U.S. patent application number 17/393752 was filed with the patent office on 2021-11-25 for systems and methods for selecting stimulation parameters based on stimulation target region, effects, or side effects.
The applicant listed for this patent is Boston Scientific Neuromodulation Corporation. Invention is credited to Stephen Carcieri, Richard Mustakos, G. Karl Steinke.
Application Number | 20210361947 17/393752 |
Document ID | / |
Family ID | 1000005754727 |
Filed Date | 2021-11-25 |
United States Patent
Application |
20210361947 |
Kind Code |
A1 |
Carcieri; Stephen ; et
al. |
November 25, 2021 |
SYSTEMS AND METHODS FOR SELECTING STIMULATION PARAMETERS BASED ON
STIMULATION TARGET REGION, EFFECTS, OR SIDE EFFECTS
Abstract
A system or method for identifying sets of stimulation
parameters can include receiving at least one image of a region of
a patient; registering the at least one image with an anatomical or
physiological atlas that identifies different anatomical or
physiological structures; identifying a desired stimulation region
using the at least one image; comparing the desired stimulation
region with each of a plurality of predetermined estimated
stimulation regions, where each of the estimated stimulation
regions is a calculated estimate of a stimulation volume for a
corresponding set of electrical stimulation parameters; selecting
one of the predetermined estimated stimulation regions based on the
comparing; and providing the corresponding set of electrical
stimulation parameters for the selected one of the predetermined
estimated stimulation regions to a user or an electrical
stimulation device. Other systems or methods use functional maps or
subregions of a region of synchronous neural activity to identify
stimulation parameters.
Inventors: |
Carcieri; Stephen; (Los
Angeles, CA) ; Steinke; G. Karl; (Valencia, CA)
; Mustakos; Richard; (Simi Valley, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Neuromodulation Corporation |
Valencia |
CA |
US |
|
|
Family ID: |
1000005754727 |
Appl. No.: |
17/393752 |
Filed: |
August 4, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16537136 |
Aug 9, 2019 |
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17393752 |
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15194336 |
Jun 27, 2016 |
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16537136 |
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62186184 |
Jun 29, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G16H 50/50 20180101;
G16H 40/63 20180101; G16H 20/30 20180101; A61N 1/36135 20130101;
A61N 1/36071 20130101; A61N 1/36082 20130101; A61N 1/3787 20130101;
A61N 1/37241 20130101; A61N 1/37247 20130101; A61N 1/0551
20130101 |
International
Class: |
A61N 1/36 20060101
A61N001/36; G16H 40/63 20060101 G16H040/63; G16H 50/50 20060101
G16H050/50; G16H 20/30 20060101 G16H020/30; A61N 1/05 20060101
A61N001/05; A61N 1/372 20060101 A61N001/372; A61N 1/378 20060101
A61N001/378 |
Claims
1. A method of providing electrical stimulation of a patient, the
method comprising: providing at least one functional map
identifying anatomical or physiological volumes that, when
stimulated, produce at least one stimulation effect or at least one
stimulation side effect in at least one patient, wherein the at
least one functional map includes an estimate of a likelihood that
the anatomical or physiological volumes will produce the at least
one stimulation effect or the at least one stimulation side effect;
identifying at least one desired stimulation effect or at least one
undesired stimulation side effect; using the at least one
functional map, identifying a desired stimulation region that
produces the at least one desired stimulation effect at a first
predetermined threshold likelihood or avoids the at least one
undesired stimulation side effect at a second predetermined
threshold likelihood; based on the desired stimulation region,
identifying an estimated stimulation region that is an estimate of
a stimulation volume for a corresponding set of electrical
stimulation parameters using an electrical stimulation lead; and
delivering electrical stimulation to the patient according to the
corresponding set of electrical stimulation parameters for the
estimated stimulation region.
2. The method of claim 1, further comprising providing the
corresponding set of electrical stimulation parameters for the
selected one of the estimated stimulation regions to an electrical
stimulation device.
3. The method of claim 2, wherein the electrical stimulation device
comprises an implantable pulse generator and an electrical
stimulation lead that is coupled to the implantable pulse generator
and comprises a plurality of electrodes, wherein the delivering the
electrical stimulation comprises delivering the electrical
stimulation by the implantable pulse generator through at least one
of the electrodes of the electrical stimulation lead according to
the corresponding set of electrical stimulation parameters for the
estimated stimulation region.
4. The method of claim 2, wherein the electrical stimulation device
comprises an external trial stimulator and an electrical
stimulation lead that is coupled to the external trial stimulator
and comprises a plurality of electrodes, wherein the delivering the
electrical stimulation comprises delivering the electrical
stimulation by the external trial stimulator through at least one
of the electrodes of the electrical stimulation lead according to
the corresponding set of electrical stimulation parameters for the
estimated stimulation region.
5. The method of claim 1, wherein the identifying the at least one
desired stimulation effect or the at least one undesired
stimulation side effect comprises identifying both the at least one
desired stimulation effect and the at least one undesired
stimulation side effect.
7. The method of claim 1, wherein the providing at least one
functional map comprises providing the at least one functional map
with scores associated with the anatomical or physiological
volumes, each score being associated with at least one of the at
least one stimulation effect or the at least one stimulation side
effect.
7. The method of claim 1, wherein the identifying the estimated
stimulation region comprises comparing the desired stimulation
region with each of a plurality of potential estimated stimulation
regions, wherein each of the potential estimated stimulation
regions is an estimate of a stimulation volume for a corresponding
set of electrical stimulation parameters using an electrical
stimulation lead; and selecting one of the potential estimated
stimulation regions as the estimated stimulation region based on
the comparing.
8. The method of claim 7, further comprising receiving at least one
selection criterion, wherein the selecting the one of the potential
estimated stimulation regions comprises selecting the one of the
potential estimated stimulation regions based on the at least one
selection criterion.
9. The method of claim 7, further comprising automatically
rejecting any of the potential estimated stimulation regions that
fails to have a predetermined amount of overlap with the desired
stimulation region.
10. The method of claim 7, further comprising obtaining the
plurality of possible estimated stimulation regions by calculating
each of the possible estimated stimulation regions.
11. The method of claim 7, further comprising obtaining the
plurality of possible estimated stimulation regions from a memory
of a device.
12. The method of claim 7, wherein the comparing comprises
determining a difference between the desired stimulation region and
each of the plurality of possible estimated stimulation
regions.
13. The method of claim 1, further comprising determining an amount
or percentage of the estimated stimulation region outside the
desired stimulation region.
14. The method of claim 1, further comprising presenting, on a
display, the desired stimulation region and the estimated
stimulation region.
15. The method of claim 14, further comprising determining, and
displaying on the display, at least one of the following: an amount
or percentage coverage of the desired stimulation region by the
estimated stimulation region, an amount or percentage of the
desired stimulation region that is outside the estimated
stimulation region, an amount or percentage of the estimated
stimulation region that covers the desired stimulation region, or
an amount or percentage of the estimated stimulation region that is
outside the desired stimulation region.
16. The method of claim 1, wherein the providing the at least one
function map comprises registering at least one patient image into
a common atlas space.
17. The method of claim 1, further comprising providing the
corresponding set of electrical stimulation parameters for the
selected one of the estimated stimulation regions to a user.
18. The method of claim 1, wherein the functional map represents an
aggregate of clinical effects across at least 10 patients.
19. The method of claim 1, wherein the identifying the at least one
desired stimulation effect or the at least one undesired
stimulation side effect comprises identifying both the at least one
desired stimulation effect and a plurality of the undesired
stimulation side effects.
20. A method of providing electrical stimulation of a patient, the
method comprising: identifying a region of synchronous neural
activity; dividing the region into a plurality of subregions;
comparing the plurality of subregions with a plurality of estimated
stimulation regions, wherein each of the estimated stimulation
regions is a calculated estimate of a stimulation volume for a
corresponding set of electrical stimulation parameters using an
electrical stimulation lead; selecting, for each of the subregions,
one of the estimated stimulation regions based on the comparisons
such that each of the selected estimated stimulation regions
overlaps with any of the other selected estimated stimulation
regions by no more than a predetermined threshold; and delivering
electrical stimulation to the patient according to the
corresponding set of electrical stimulation parameters for each of
the selected estimated stimulation regions.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/537,136, filed Aug. 9, 2019, which is a
divisional of U.S. patent application Ser. No. 15/194,336, filed
Jun. 27, 2016, which claims the benefit under 35 U.S.C. .sctn.
119(e) of U.S. Provisional Patent Application Ser. No. 62/186,184,
filed Jun. 29, 2015, all of which are incorporated herein by
reference.
FIELD
[0002] The present invention is directed to the area of implantable
electrical stimulation systems and methods of making and using the
systems. The present invention is also directed to methods of
selecting stimulation parameters based on desired stimulation
effects or undesired stimulation side effects.
BACKGROUND
[0003] Implantable electrical stimulation systems have proven
therapeutic in a variety of diseases and disorders. For example,
spinal cord stimulation systems have been used as a therapeutic
modality for the treatment of chronic pain syndromes. Peripheral
nerve stimulation has been used to treat chronic pain syndrome and
incontinence, with a number of other applications under
investigation. Functional electrical stimulation systems have been
applied to restore some functionality to paralyzed extremities in
spinal cord injury patients. Stimulation of the brain, such as deep
brain stimulation, can be used to treat a variety of diseases or
disorders.
[0004] Stimulators have been developed to provide therapy for a
variety of treatments. A stimulator can include a control module
(with a pulse generator), one or more leads, and an array of
stimulator electrodes on each lead. The stimulator electrodes are
in contact with or near the nerves, muscles, or other tissue to be
stimulated. The pulse generator in the control module generates
electrical pulses that are delivered by the electrodes to body
tissue.
BRIEF SUMMARY
[0005] One embodiment is a system for identifying a set of
stimulation parameters, the system includes a computer processor
configured and arranged to perform the following actions:
identifying a desired stimulation region; comparing the desired
stimulation region with each of a plurality of predetermined
stimulation regions, where each of the stimulation regions can be a
defined region or a calculated estimate of a stimulation volume for
a corresponding set of electrical stimulation parameters using an
electrical stimulation lead; selecting one of the predetermined
stimulation regions based on the comparing; and providing the
corresponding set of electrical stimulation parameters for the
selected one of the predetermined stimulation regions to a user or
an electrical stimulation device.
[0006] Another embodiment is a non-transitory computer-readable
medium having processor-executable instructions for identifying a
set of stimulation parameters, the processor-executable
instructions when installed onto a device enable the device to
perform actions, including: identifying a desired stimulation
region; comparing the desired stimulation region with each of a
plurality of predetermined stimulation regions, where each of the
stimulation regions can be a defined region or a calculated
estimate of a stimulation volume for a corresponding set of
electrical stimulation parameters using an electrical stimulation
lead; selecting one of the predetermined stimulation regions based
on the comparing; and providing the corresponding set of electrical
stimulation parameters for the selected one of the predetermined
stimulation regions to a user or an electrical stimulation
device.
[0007] Yet another embodiment is a method for identifying a set of
stimulation parameters. The method includes identifying a desired
stimulation region; comparing the desired stimulation region with
each of a plurality of predetermined stimulation regions, where
each of the stimulation regions can be a defined region or a
calculated estimate of a stimulation volume for a corresponding set
of electrical stimulation parameters using an electrical
stimulation lead; selecting one of the predetermined stimulation
regions based on the comparing; and providing the corresponding set
of electrical stimulation parameters for the selected one of the
predetermined stimulation regions to a user or an electrical
stimulation device.
[0008] In at least some embodiments of the system, non-transitory
computer-readable medium, or method described above, the actions
further comprise: receiving at least one image of an anatomical or
physiological region of a patient; and registering the at least one
image with an anatomical or physiological atlas that identifies a
plurality of different anatomical or physiological structures;
where identifying a desired stimulation region comprises
identifying a desired stimulation region using the at least one
image. In at least some embodiments of the system, non-transitory
computer-readable medium, or method described above, receiving at
least one image includes receiving an image with the electrical
stimulation lead implanted within the anatomical or physiological
region. In at least some embodiments of the system, non-transitory
computer-readable medium, or method described above, receiving at
least one image includes receiving a first image of an anatomical
or physiological region and a second image of the anatomical or
physiological region with the electrical stimulation lead implanted
within the anatomical or physiological region.
[0009] A further embodiment is a system for identifying a set of
stimulation parameters, the system includes a computer processor
configured and arranged to perform the following acts: providing at
least one functional map identifying anatomical or physiological
volumes that, when stimulated, produce at least one stimulation
effect or stimulation side effect in at least one patient along
with an estimate of a likelihood that the anatomical or
physiological volume will produce the at least one stimulation
effect or stimulation side effect; identifying at least one desired
stimulation effect or undesired stimulation side effect; using the
at least one functional map, identifying a desired stimulation
region that produces the at least one desired stimulation effect at
a predetermined threshold likelihood or avoid the undesired
stimulation side effect at a predetermined threshold likelihood;
comparing the desired stimulation region with each of a plurality
of stimulation regions, where each of the stimulation regions is a
calculated estimate of a stimulation volume for a corresponding set
of electrical stimulation parameters using an electrical
stimulation lead; selecting one of the stimulation regions based on
the comparing; and providing the corresponding set of electrical
stimulation parameters for the selected one of the stimulation
regions to a user or an electrical stimulation device.
[0010] Another embodiment is a non-transitory computer-readable
medium having processor-executable instructions for identifying a
set of stimulation parameters, the processor-executable
instructions when installed onto a device enable the device to
perform actions, including: providing at least one functional map
identifying anatomical or physiological volumes that, when
stimulated, produce at least one stimulation effect or stimulation
side effect in at least one patient along with an estimate of a
likelihood that the anatomical or physiological volume will produce
the at least one stimulation effect or stimulation side effect;
identifying at least one desired stimulation effect or undesired
stimulation side effect; using the at least one functional map,
identifying a desired stimulation region that produces the at least
one desired stimulation effect at a predetermined threshold
likelihood or avoid the undesired stimulation side effect at a
predetermined threshold likelihood; comparing the desired
stimulation region with each of a plurality of estimated
stimulation regions, where each of the estimated stimulation
regions is a calculated estimate of a stimulation volume for a
corresponding set of electrical stimulation parameters using an
electrical stimulation lead; selecting one of the estimated
stimulation regions based on the comparing; and providing the
corresponding set of electrical stimulation parameters for the
selected one of the estimated stimulation regions to a user or an
electrical stimulation device.
[0011] Yet another embodiment is a method for identifying a set of
stimulation parameters. The method includes providing at least one
functional map identifying anatomical or physiological volumes
that, when stimulated, produce at least one stimulation effect or
stimulation side effect in at least one patient along with an
estimate of a likelihood that the anatomical or physiological
volume will produce the at least one stimulation effect or
stimulation side effect; identifying at least one desired
stimulation effect or undesired stimulation side effect; using the
at least one functional map, identifying a desired stimulation
region that produces the at least one desired stimulation effect at
a predetermined threshold likelihood or avoid the undesired
stimulation side effect at a predetermined threshold likelihood;
comparing the desired stimulation region with each of a plurality
of estimated stimulation regions, where each of the estimated
stimulation regions is a calculated estimate of a stimulation
volume for a corresponding set of electrical stimulation parameters
using an electrical stimulation lead; selecting one of the
estimated stimulation regions based on the comparing; and providing
the corresponding set of electrical stimulation parameters for the
selected one of the estimated stimulation regions to a user or an
electrical stimulation device.
[0012] In at least some embodiments of the system, non-transitory
computer-readable medium, or method described above, identifying
the desired stimulation region includes selecting the desired
stimulation region to produce the at least one desired stimulation
effect and to avoid any stimulation side effects above a threshold
likelihood. In at least some embodiments of the system,
non-transitory computer-readable medium, or method described above,
identifying the desired stimulation region includes selecting the
desired stimulation region to produce the at least one desired
stimulation effect and to avoid at least one identified stimulation
side effect above a threshold likelihood. In at least some
embodiments of the system, non-transitory computer-readable medium,
or method described above, providing at least one functional map
includes providing at least one functional map with scores
associated with the anatomical or physiological volumes, each score
being associated with at least one of the stimulation effects or
stimulation side effects.
[0013] A further embodiment is a system for identifying a set of
stimulation parameters that includes a computer processor
configured and arranged to perform the following acts: identifying
a region of synchronous neural activity; dividing the region into a
plurality of subregions; comparing the plurality of subregions with
each of a plurality of estimated stimulation regions, where each of
the estimated stimulation regions is a calculated estimate of a
stimulation volume for a corresponding set of electrical
stimulation parameters using an electrical stimulation lead;
selecting, for each of the subregions, one of the estimated
stimulation regions based on the comparisons such that each of the
selected estimated stimulation regions overlaps with any of the
other selected estimated stimulation regions by no more than a
predetermined threshold; and providing the corresponding set of
electrical stimulation parameters for each of the selected
estimated stimulation regions to a user or an electrical
stimulation device.
[0014] Another embodiment is a non-transitory computer-readable
medium having processor-executable instructions for identifying a
set of stimulation parameters, the processor-executable
instructions when installed onto a device enable the device to
perform actions, including: identifying a region of synchronous
neural activity; dividing the region into a plurality of
subregions; comparing the plurality of subregions with each of a
plurality of estimated stimulation regions, where each of the
estimated stimulation regions is a calculated estimate of a
stimulation volume for a corresponding set of electrical
stimulation parameters using an electrical stimulation lead;
selecting, for each of the subregions, one of the estimated
stimulation regions based on the comparisons such that each of the
selected estimated stimulation regions overlaps with any of the
other selected estimated stimulation regions by no more than a
predetermined threshold; and providing the corresponding set of
electrical stimulation parameters for each of the selected
estimated stimulation regions to a user or an electrical
stimulation device.
[0015] Yet another embodiment is a method for identifying a set of
stimulation parameters. The method includes identifying a region of
synchronous neural activity; dividing the region into a plurality
of subregions; comparing the plurality of subregions with each of a
plurality of estimated stimulation regions, where each of the
estimated stimulation regions is a calculated estimate of a
stimulation volume for a corresponding set of electrical
stimulation parameters using an electrical stimulation lead;
selecting, for each of the subregions, one of the estimated
stimulation regions based on the comparisons such that each of the
selected estimated stimulation regions overlaps with any of the
other selected estimated stimulation regions by no more than a
predetermined threshold; and providing the corresponding set of
electrical stimulation parameters for each of the selected
estimated stimulation regions to a user or an electrical
stimulation device.
[0016] In at least some embodiments of the system, non-transitory
computer-readable medium, or method described above, identifying a
region of synchronous neural activity includes receiving the region
from a user. In at least some embodiments of the system,
non-transitory computer-readable medium, or method described above,
dividing the region includes dividing the regions into the
plurality of subregions, wherein each subregion overlaps by no more
than a predetermined threshold percentage with any other of the
plurality of subregions. In at least some embodiments of the
system, non-transitory computer-readable medium, or method
described above, each of the selected estimated stimulation regions
overlaps with any of the other selected estimated stimulation
regions by no more than a predetermined threshold percentage. In at
least some embodiments of the system, non-transitory
computer-readable medium, or method described above, each of the
selected estimated stimulation regions does not overlap with any of
the other selected estimated stimulation regions.
[0017] In at least some embodiments, any of the systems described
above further includes the electrical stimulation device which
includes the electrical stimulation lead. In at least some
embodiments, any of the systems described above further includes an
implantable pulse generator and providing the corresponding set of
electrical stimulation parameters includes providing the
corresponding set of electrical stimulation parameters to the
implantable pulse generator.
[0018] In at least some embodiments of any of the systems,
non-transitory computer-readable media, or methods described above,
selecting one of the estimated stimulation regions includes
selecting the one of the estimated stimulation regions based on at
least one selection criterion supplied by the user. In at least
some embodiments of any of the systems, non-transitory
computer-readable media, or methods described above, selecting one
of the estimated stimulation regions includes selecting the one of
the estimated stimulation regions based on at least one threshold
criterion supplied by the user.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] Non-limiting and non-exhaustive embodiments of the present
invention are described with reference to the following drawings.
In the drawings, like reference numerals refer to like parts
throughout the various figures unless otherwise specified.
[0020] For a better understanding of the present invention,
reference will be made to the following Detailed Description, which
is to be read in association with the accompanying drawings,
wherein:
[0021] FIG. 1 is a schematic view of one embodiment of an
electrical stimulation system, according to the invention;
[0022] FIG. 2 is a schematic side view of one embodiment of an
electrical stimulation lead, according to the invention;
[0023] FIG. 3 is a schematic block diagram of one embodiment of a
system for determining stimulation parameters, according to the
invention;
[0024] FIG. 4 is a flowchart of one embodiment of a method of
determining stimulation parameters, according to the invention;
[0025] FIG. 5 is a flowchart of a second embodiment of a method of
determining stimulation parameters, according to the invention;
and
[0026] FIG. 6 is a flowchart of a third embodiment of a method of
determining stimulation parameters, according to the invention.
DETAILED DESCRIPTION
[0027] The present invention is directed to the area of implantable
electrical stimulation systems and methods of making and using the
systems. The present invention is also directed to methods of
selecting stimulation parameters based on desired stimulation
effects or undesired stimulation side effects.
[0028] Suitable implantable electrical stimulation systems include,
but are not limited to, a least one lead with one or more
electrodes disposed on a distal end of the lead and one or more
terminals disposed on one or more proximal ends of the lead. Leads
include, for example, percutaneous leads and paddle leads. Examples
of electrical stimulation systems with leads are found in, for
example, U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032;
6,741,892; 7,244,150; 7,450,997; 7,672,734;7,761,165; 7,783,359;
7,792,590; 7,809,446; 7,949,395; 7,974,706; 8,175,710; 8,224,450;
8,271,094; 8,295,944; 8,364,278; 8,391,985; and 8,688,235; and U.S.
Patent Applications Publication Nos. 2007/0150036; 2009/0187222;
2009/0276021; 2010/0076535; 2010/0268298; 2011/0005069;
2011/0004267; 2011/0078900; 2011/0130817; 2011/0130818;
2011/0238129; 2011/0313500; 2012/0016378; 2012/0046710;
2012/0071949; 2012/0165911; 2012/0197375; 2012/0203316;
2012/0203320; 2012/0203321; 2012/0316615; 2013/0105071; and
2013/0197602, all of which are incorporated by reference. In the
discussion below, a percutaneous lead will be exemplified, but it
will be understood that the methods and systems described herein
are also applicable to paddle leads.
[0029] A percutaneous lead for electrical stimulation (for example,
deep brain or spinal cord stimulation) includes stimulation
electrodes that can be ring electrodes or segmented electrodes that
extend only partially around the circumference of the lead or any
combination thereof. The segmented electrodes can be provided in
sets of electrodes, with each set having electrodes
circumferentially distributed about the lead at a particular
longitudinal position. For illustrative purposes, the leads are
described herein relative to use for deep brain stimulation, but it
will be understood that any of the leads can be used for
applications other than deep brain stimulation, including spinal
cord stimulation, peripheral nerve stimulation, or stimulation of
other nerves and tissues.
[0030] Turning to FIG. 1, one embodiment of an electrical
stimulation system 10 includes one or more stimulation leads 12 and
an implantable pulse generator (IPG) 14. The system 10 can also
include one or more of an external remote control (RC) 16, a
clinician's programmer (CP) 18, an external trial stimulator (ETS)
20, or an external charger 22.
[0031] The IPG 14 is physically connected, optionally via one or
more lead extensions 24, to the stimulation lead(s) 12. Each lead
carries multiple electrodes 26 arranged in an array. The IPG 14
includes pulse generation circuitry that delivers electrical
stimulation energy in the form of, for example, a pulsed electrical
waveform (i.e., a temporal series of electrical pulses) to the
electrode array 26 in accordance with a set of stimulation
parameters. The implantable pulse generator can be implanted into a
patient's body, for example, below the patient's clavicle area or
within the patient's buttocks or abdominal cavity. The implantable
pulse generator can have eight stimulation channels which may be
independently programmable to control the magnitude of the current
or voltage stimulus from each channel. In some embodiments, the
implantable pulse generator can have more or fewer than eight
stimulation channels (e.g., 4-, 6-, 16-, 32-, or more stimulation
channels). The implantable pulse generator can have one, two,
three, four, or more connector ports, for receiving the terminals
of the leads.
[0032] The ETS 20 may also be physically connected, optionally via
the percutaneous lead extensions 28 and external cable 30, to the
stimulation leads 12. The ETS 20, which has similar pulse
generation circuitry as the IPG 14, also delivers electrical
stimulation energy in the form of, for example, a pulsed electrical
waveform to the electrode array 26 in accordance with a set of
stimulation parameters. One difference between the ETS 20 and the
IPG 14 is that the ETS 20 is often a non-implantable device that is
used on a trial basis after the neurostimulation leads 12 have been
implanted and prior to implantation of the IPG 14, to test the
responsiveness of the stimulation that is to be provided. Any
functions described herein with respect to the IPG 14 can likewise
be performed with respect to the ETS 20.
[0033] The RC 16 may be used to telemetrically communicate with or
control the IPG 14 or ETS 20 via a uni- or bi-directional wireless
communications link 32. Once the IPG 14 and neurostimulation leads
12 are implanted, the RC 16 may be used to telemetrically
communicate with or control the IPG 14 via a uni- or bi-directional
communications link 34. Such communication or control allows the
IPG 14 to be turned on or off and to be programmed with different
stimulation parameter sets. The IPG 14 may also be operated to
modify the programmed stimulation parameters to actively control
the characteristics of the electrical stimulation energy output by
the IPG 14. The CP 18 allows a user, such as a clinician, the
ability to program stimulation parameters for the IPG 14 and ETS 20
in the operating room and in follow-up sessions.
[0034] The CP 18 may perform this function by indirectly
communicating with the IPG 14 or ETS 20, through the RC 16, via a
wired or wireless communications link 36. Alternatively, the CP 18
may directly communicate with the IPG 14 or ETS 20 via a wired or
wireless communications link (not shown). The stimulation
parameters provided by the CP 18 are also used to program the RC
16, so that the stimulation parameters can be subsequently modified
by operation of the RC 16 in a stand-alone mode (i.e., without the
assistance of the CP 18).
[0035] For purposes of brevity, the details of the RC 16, CP 18,
ETS 20, and external charger 22 will not be further described
herein. Details of exemplary embodiments of these devices are
disclosed in U.S. Pat. No. 6,895,280, which is expressly
incorporated herein by reference. Other examples of electrical
stimulation systems can be found at U.S. Pat. Nos. 6,181,969;
6,516,227; 6,609,029; 6,609,032; 6,741,892; 7,949,395; 7,244,150;
7,672,734; 7,761,165; 7,974,706; 8,175,710; 8,224,450; and
8,364,278; and U.S. Patent Application Publication No.
2007/0150036, as well as the other references cited above, all of
which are incorporated by reference.
[0036] FIG. 2 illustrates one embodiment of a lead 110 with
electrodes 125 disposed at least partially about a circumference of
the lead 110 along a distal end portion of the lead and terminals
135 disposed along a proximal end portion of the lead.
The lead 110 can be implanted near or within the desired portion of
the body to be stimulated such as, for example, the brain, spinal
cord, or other body organs or tissues. In one example of operation
for deep brain stimulation, access to the desired position in the
brain can be accomplished by drilling a hole in the patient's skull
or cranium with a cranial drill (commonly referred to as a burr),
and coagulating and incising the dura mater, or brain covering. The
lead 110 can be inserted into the cranium and brain tissue with the
assistance of a stylet (not shown). The lead 110 can be guided to
the target location within the brain using, for example, a
stereotactic frame and a microdrive motor system. In some
embodiments, the microdrive motor system can be fully or partially
automatic. The microdrive motor system may be configured to perform
one or more the following actions (alone or in combination): insert
the lead 110, advance the lead 110, retract the lead 110, or rotate
the lead 110.
[0037] In some embodiments, measurement devices coupled to the
muscles or other tissues stimulated by the target neurons, or a
unit responsive to the patient or clinician, can be coupled to the
implantable pulse generator or microdrive motor system. The
measurement device, user, or clinician can indicate a response by
the target muscles or other tissues to the stimulation or recording
electrode(s) to further identify the target neurons and facilitate
positioning of the stimulation electrode(s). For example, if the
target neurons are directed to a muscle experiencing tremors, a
measurement device can be used to observe the muscle and indicate
changes in tremor frequency or amplitude in response to stimulation
of neurons. Alternatively, the patient or clinician can observe the
muscle and provide feedback.
[0038] The lead 110 for deep brain stimulation can include
stimulation electrodes, recording electrodes, or both. In at least
some embodiments, the lead 110 is rotatable so that the stimulation
electrodes can be aligned with the target neurons after the neurons
have been located using the recording electrodes.
[0039] Stimulation electrodes may be disposed on the circumference
of the lead 110 to stimulate the target neurons. Stimulation
electrodes may be ring-shaped so that current projects from each
electrode equally in every direction from the position of the
electrode along a length of the lead 110. In the embodiment of FIG.
2, two of the electrodes 120 are ring electrodes 120. Ring
electrodes typically do not enable stimulus current to be directed
from only a limited angular range around of the lead. Segmented
electrodes 130, however, can be used to direct stimulus current to
a selected angular range around the lead. When segmented electrodes
are used in conjunction with an implantable pulse generator that
delivers constant current stimulus, current steering can be
achieved to more precisely deliver the stimulus to a position
around an axis of the lead (i.e., radial positioning around the
axis of the lead). To achieve current steering, segmented
electrodes can be utilized in addition to, or as an alternative to,
ring electrodes.
[0040] The lead 100 includes a lead body 110, terminals 135, and
one or more ring electrodes 120 and one or more sets of segmented
electrodes 130 (or any other combination of electrodes). The lead
body 110 can be formed of a biocompatible, non-conducting material
such as, for example, a polymeric material. Suitable polymeric
materials include, but are not limited to, silicone, polyurethane,
polyurea, polyurethane-urea, polyethylene, or the like. Once
implanted in the body, the lead 100 may be in contact with body
tissue for extended periods of time. In at least some embodiments,
the lead 100 has a cross-sectional diameter of no more than 1.5 mm
and may be in the range of 0.5 to 1.5 mm. In at least some
embodiments, the lead 100 has a length of at least 10 cm and the
length of the lead 100 may be in the range of 10 to 70 cm.
[0041] The electrodes 125 can be made using a metal, alloy,
conductive oxide, or any other suitable conductive biocompatible
material. Examples of suitable materials include, but are not
limited to, platinum, platinum iridium alloy, iridium, titanium,
tungsten, palladium, palladium rhodium, or the like. Preferably,
the electrodes are made of a material that is biocompatible and
does not substantially corrode under expected operating conditions
in the operating environment for the expected duration of use.
[0042] Each of the electrodes can either be used or unused (OFF).
When the electrode is used, the electrode can be used as an anode
or cathode and carry anodic or cathodic current. In some instances,
an electrode might be an anode for a period of time and a cathode
for a period of time.
[0043] Deep brain stimulation leads may include one or more sets of
segmented electrodes. Segmented electrodes may provide for superior
current steering than ring electrodes because target structures in
deep brain stimulation are not typically symmetric about the axis
of the distal electrode array. Instead, a target may be located on
one side of a plane running through the axis of the lead. Through
the use of a radially segmented electrode array ("RSEA"), current
steering can be performed not only along a length of the lead but
also around a circumference of the lead. This provides precise
three-dimensional targeting and delivery of the current stimulus to
neural target tissue, while potentially avoiding stimulation of
other tissue. Examples of leads with segmented electrodes include
U.S. Patent Application Publications Nos. 2010/0268298;
2011/0005069; 2011/0130803; 2011/0130816; 2011/0130817;
2011/0130818; 2011/0078900; 2011/0238129; 2012/0016378;
2012/0046710; 2012/0071949; 2012/0165911; 2012/197375;
2012/0203316; 2012/0203320; 2012/0203321, all of which are
incorporated herein by reference.
[0044] An electrical stimulation lead can be implanted in the body
of a patient (for example, in the brain or spinal cord of the
patient) and used to stimulate surrounding tissue. It is useful to
estimate the effective region of stimulation (often called a volume
of activation (VOA) or stimulation field model (SFM)) given the
position of the lead and its electrodes in the patient's body and
the stimulation parameters used to generate the stimulation. Any
suitable method for determining the VOA and for graphically
displaying the VOA relative to patient anatomy can be used
including those described in, for example, U.S. Pat. Nos.
8,326,433; 8,675,945; 8,831,731; 8,849,632; and 8,958,615; U.S.
Patent Application Publications Nos. 2009/0287272; 2009/0287273;
2012/0314924; 2013/0116744; 2014/0122379; and 2015/0066111; and
U.S. Provisional Patent Application Ser. No. 62/030,655, all of
which are incorporated herein by reference. Several of these
references also discloses methods and systems for registering an
atlas of body structures to imaged patient physiology. As used
herein, unless indicated otherwise, the term "estimated stimulation
region" can refer to a VOA; a SFM; an estimate of an electric
field, potential field, activating function field, Hermitian of an
activating function, or any combination thereof or the like.
[0045] In conventional systems, a VOA is determined based on a set
of stimulation parameters input into the system. The VOA can then
be modified by the user by modifying the stimulation parameters and
determining the new VOA from the modified stimulation parameters.
This allows the user to tailor the stimulation volume.
[0046] In contrast to these conventional systems which determine
the VOA from user-selected stimulation parameters, in at least some
embodiments, the present systems or methods allow the user to
define the volume of tissue that is desired for stimulation and
then the systems or methods determine a set of stimulation
parameters based on that volume. There are a number of different
methods for selecting a desired stimulation volume described below.
In some embodiments, the user selects the volume directly. In other
embodiments, the user selects the volume indirectly by indicating
one or more stimulation effects to achieve or stimulation side
effects to avoid. Alternatively, the user or system can select a
volume based on regions with synchronous neural activity.
[0047] FIG. 3 illustrates one embodiment of a system for
determining electrical stimulation parameters. The system can
include a computing device 300 or any other similar device that
includes a processor 302 and a memory 304, a display 306, an input
device 308, and, optionally, the electrical stimulation system 312.
The system 300 may also optionally include one or more imaging
systems 310.
[0048] The computing device 300 can be a computer, tablet, mobile
device, or any other suitable device for processing information.
The computing device 300 can be local to the user or can include
components that are non-local to the computer including one or both
of the processor 302 or memory 304 (or portions thereof). For
example, in some embodiments, the user may operate a terminal that
is connected to a non-local computing device. In other embodiments,
the memory can be non-local to the user.
[0049] The computing device 300 can utilize any suitable processor
302 including one or more hardware processors that may be local to
the user or non-local to the user or other components of the
computing device. The processor 302 is configured to execute
instructions provided to the processor, as described below.
[0050] Any suitable memory 304 can be used for the computing device
302. The memory 304 illustrates a type of computer-readable media,
namely computer-readable storage media. Computer-readable storage
media may include, but is not limited to, nonvolatile,
non-transitory, removable, and non-removable media implemented in
any method or technology for storage of information, such as
computer readable instructions, data structures, program modules,
or other data. Examples of computer-readable storage media include
RAM, ROM, EEPROM, flash memory, or other memory technology, CD-ROM,
digital versatile disks ("DVD") or other optical storage, magnetic
cassettes, magnetic tape, magnetic disk storage or other magnetic
storage devices, or any other medium which can be used to store the
desired information and which can be accessed by a computing
device.
[0051] Communication methods provide another type of computer
readable media; namely communication media. Communication media
typically embodies computer-readable instructions, data structures,
program modules, or other data in a modulated data signal such as a
carrier wave, data signal, or other transport mechanism and include
any information delivery media. The terms "modulated data signal,"
and "carrier-wave signal" includes a signal that has one or more of
its characteristics set or changed in such a manner as to encode
information, instructions, data, and the like, in the signal. By
way of example, communication media includes wired media such as
twisted pair, coaxial cable, fiber optics, wave guides, and other
wired media and wireless media such as acoustic, RF, infrared, and
other wireless media.
[0052] The display 306 can be any suitable display device, such as
a monitor, screen, display, or the like, and can include a printer.
The input device 308 can be, for example, a keyboard, mouse, touch
screen, track ball, joystick, voice recognition system, or any
combination thereof, or the like.
[0053] One or more imaging systems 310 can be used including, but
not limited to, MRI, CT, ultrasound, or other imaging systems. The
imaging system 310 may communicate through a wired or wireless
connection with the computing device 300 or, alternatively or
additionally, a user can provide images from the imaging system 310
using a computer-readable medium or by some other mechanism.
[0054] The electrical stimulation system 312 can include, for
example, any of the components illustrated in FIG. 1. The
electrical stimulation system 312 may communicate with the
computing device 300 through a wired or wireless connection or,
alternatively or additionally, a user can provide information
between the electrical stimulation system 312 and the computing
device 300 using a computer-readable medium or by some other
mechanism. In some embodiments, the computing device 300 may
include part of the electrical stimulation system, such as, for
example, the IPG, CP, RC, ETS, or any combination thereof.
[0055] The methods and systems described herein may be embodied in
many different forms and should not be construed as limited to the
embodiments set forth herein. Accordingly, the methods and systems
described herein may take the form of an entirely hardware
embodiment, an entirely software embodiment or an embodiment
combining software and hardware aspects. Systems referenced herein
typically include memory and typically include methods for
communication with other devices including mobile devices. Methods
of communication can include both wired and wireless (e.g., RF,
optical, or infrared) communications methods and such methods
provide another type of computer readable media; namely
communication media. Wired communication can include communication
over a twisted pair, coaxial cable, fiber optics, wave guides, or
the like, or any combination thereof. Wireless communication can
include RF, infrared, acoustic, near field communication,
Bluetooth.TM., or the like, or any combination thereof.
[0056] Stimulation is one type of neuromodulation. Types of
neuromodulation can include, for example, stimulation (application
of a stimulating field or drug), activation (actuating neurological
tissue), depression (reducing the likelihood of activation of the
neurological tissue), silencing (preventing the activation of the
neurological tissue), or other forms of neuromodulation. Although
stimulation is referred to in the embodiments below, it will be
recognized that any other type of neuromodulation can be
substituted for stimulation unless indicated otherwise. Moreover,
multiple forms of neuromodulation as described previously may be
used in various combinations in the methods and systems described
herein, with varying temporal order or relation, on the same target
or targets. The intervention can be accomplished using electrical
stimulation, optical stimulation, drug stimulation, or the like or
any combination thereof. The one or more targets may be selected
with respect to the desired type of intervention, for example, one
or more targets can be selected for activation, one or more targets
for depression, and one or more targets for silencing, or any
combination thereof. When multiple targets are identified, the
targets may be selected for the same type of intervention or
different targets may be selected for different types of
intervention.
[0057] FIG. 4 is a flowchart illustrating one method for
determining a set of stimulation parameters based on a
user-selected stimulation volume. In step 402, at least one image
of an anatomical or physiological region of a patient is received.
The image can be any suitable image such as a MRI, CT, ultrasound,
or other image. At least one image preferably also includes an
implanted electrical stimulation lead within the image so that the
position, and, preferably, the orientation, of the lead relative to
the patient tissue can be identified. In at least some embodiments,
more than one image can be received. For example, in at least some
embodiments, a MRI image of an anatomical or physiological region,
such as the brain, spinal cord, or other organ or tissue, or a
portion thereof, can be obtained to show soft tissue portions of
the region. A CT or MRI scan can also be obtained for the
anatomical or physiological region with the electrical stimulation
lead implanted to identify the position and orientation of the
lead. In at least some embodiments, the two or more images may be
registered with each other.
[0058] In other embodiments, an image is not used, but the user or
system estimates the position or orientation of the lead within the
patient. This estimation may be based on, for example, surgical
results, a surgical plan, external observations, or the like. In at
least some embodiments, the estimate is based on a proposed
position of a lead in the patient. The lead may or may not have
been actually implanted in the patient. In some embodiments, the
system can be used to plan a surgical implantation of a lead by
investigating different placements or orientations. In the
remainder of the discussion regarding the embodiment of FIG. 4,
reference will be made to at least one image, but it will be
understood that instead of an image an estimate of position or
orientation or a proposed position or orientation of the lead can
be used.
[0059] In step 404, the at least one image received in step 402 is
registered with an anatomical or physiological atlas, such as a
neuroanatomical atlas, to associate anatomical or physiological
structures from the atlas with the at least one image. In at least
some embodiments, the registered image(s) can be segmented into
volume units that can, for example, each correspond to specific
anatomical or physiological structures, or portions of anatomical
or physiological structures, or correspond to any other division of
the imaged region. In at least some embodiments, the anatomical or
physiological structures or segmented volumes can be labeled,
numbered, or otherwise differentiated for the user on, for example,
a display for review by the user.
[0060] In step 406, the user identifies a desired stimulation
region. In embodiments in which at least one image is received the
desired stimulation region can be identified within, or at least
partially within, the imaged anatomical or physiological region. In
at least some embodiments, a user can select the desired
stimulation region by drawing or otherwise indicating the region on
a display or other device. In at least some embodiments, a user can
select the desired stimulation region by entering the name of one
or more anatomical or physiological structures or by selecting one
or more anatomical or physiological structures on a list. Any other
suitable method for selecting a desired stimulation region can be
used.
[0061] In step 408, the desired stimulation region is compared to
multiple predetermined estimated stimulation regions. The system
may utilize any number of predetermined estimated stimulation
regions, such as at least 10, 25, 50, 100, 200, or 500
predetermined estimated stimulation regions. These estimated
stimulation regions are each associated with a set of stimulation
parameters and can be predetermined using any method of calculation
or estimation, including those disclosed in the references cited
above, using the corresponding set of stimulation parameters.
Additionally or alternatively, the desired stimulation region can
be compared to one or more estimated stimulation regions that are
calculated or estimated after selection of the desired stimulation
region.
[0062] In at least some embodiments, the estimated stimulation
regions are estimated or determined with respect to the lead and
then those estimated stimulation regions are registered to the
anatomical or physiological atlas, images, or the desired
stimulation region based on the position or orientation of the lead
within the patient. In at least some embodiments, the comparisons
between the desired stimulation regions and the multiple
predetermined estimated stimulation regions include, for example, a
quantitative determination of the fit of the identified stimulation
region with one or more of the estimated stimulation regions.
[0063] In some embodiments, the system can reject an estimated
stimulation region that fails to have a predetermined amount or
percentage of overlap, or fails any other acceptance criteria, with
respect to the identified stimulation region. In some embodiments,
the system can reject an estimated stimulation region that fails to
overlap with a predetermined amount or percentage of the identified
stimulation region. The system may include other threshold
determinations or, in at least some embodiments, the user may
select one or more threshold requirements.
[0064] The comparison may include reporting comparative information
on a display or other device to the user. Such comparative
information can include one or more of, for example, the amount or
percentage coverage of the desired stimulation region by the
estimated stimulation region, the amount or percentage of the
desired stimulation region that is outside the estimated
stimulation region, the amount or percentage of the estimated
stimulation region that covers the desired stimulation region, the
amount or percentage of the estimated stimulation region that is
outside the desired stimulation region, other anatomical or
physiological structures that may be stimulated by the estimated
stimulation region, or the like. Alternatively or additionally, the
desired stimulation region and the estimated stimulation region can
be displayed to illustrate the overlap between the two. In some
embodiments, the system may only report comparative information on
one or more, but less than all, of the estimated stimulation
regions or display only one or more, but less than all, of the
estimated stimulation regions. The selection of which estimated
stimulation regions to include in the report or display may be by
the best fit or other criteria that the system or user
determines.
[0065] In step 410, one of the predetermined estimated stimulation
regions is selected based on the comparisons. In some embodiments,
one of the predetermined estimated stimulation regions is selected
by a user, preferably based on comparative information provided by
the system to the user. In some embodiments, one of the
predetermined estimated stimulation regions is selected by the
system based on the comparisons. In at least some embodiments, the
user can set selection criteria such as, for example, one or more
thresholds for overlap, non-overlap, or the like or may provide
rules or criteria for selecting among estimated stimulation regions
that meet the thresholds, such as priority selection factor(s) or
weighting of comparative information. As an example, the system may
determine a "goodness-of-fit" based on the difference between the
desired stimulation region and the estimated stimulation region and
the system selects the estimated stimulation region with the best
"goodness-of-fit". In at least some embodiments, the system may
allow the user to override the automatic selection by the system so
that the user can select another estimated stimulation region.
[0066] In step 412, stimulation parameters for the selected
estimated stimulation region can be provided to the user or
directly to an implantable pulse generator, external trial
stimulator, or other device that generates the electrical
stimulation. These parameters can be provided by a wired
connection, a wireless connection, or in any other suitable manner.
In some embodiments, the system may allow a user to modify the
stimulation parameters.
[0067] FIG. 5 is a flowchart illustrating one method for
determining a set of stimulation parameters based on a
user-selected stimulation effects or side effects. In step 502, one
or more functional maps can be provided with each functional map
identifying anatomical or physiological regions that produce one or
more stimulation effects or stimulation side effects (collectively,
"clinical effects") when electrically stimulated.
[0068] One example of a method for forming a functional map
includes registering patient images (for example, MRI images) into
a common atlas space. Based on this registration, the therapeutic
and side effects of various stimulation parameters applied to the
patients can be associated with anatomical or physiological
structures or other volume units in the common atlas space. The
individual anatomical or physiological structures or other volume
units into which the atlas space is divided can be referred to as
"voxels". For each set of stimulation parameters, an estimated
stimulation region can be calculated or estimated. Stimulation
effects or side effects that are identified by the user or patient
when stimulated using the set of stimulation parameters can then be
associated with the voxels in the estimated stimulation region. In
at least some embodiments, a score can be associated with any
clinical effect associated with the voxel. The score may be based
on any suitable rating scale (for example, the Unified Parkinson's
Disease Rating Scale (UPDRS)).
[0069] In at least some embodiments, these mapped clinical effects
can be aggregated across patients (for example, at least 5, 10, 20,
25, 50, or 100 patients or more) to generate an estimation of the
likelihood for achieving a certain clinical effect given activation
of a voxel at a given location in the common atlas space. For
example, p(R.gtoreq.2|v) could be the estimated probability of at
least a 2-point therapeutic improvement in rigidity (R) given
activation of voxel v, where this estimated probability is derived
directly from the number of patients for which voxel v was
stimulated. As an example of this estimated probability, if a total
of 40 patients had voxel v stimulated and 30/40 of them experienced
a rigidity improvement of 2 points or greater,
p(R.gtoreq.2|v)=0.75. One or more (or even all) of the voxels in
the atlas space can be labeled with multiple probabilities of being
associated with multiple clinical effects, including stimulation
effects and stimulation side effects.
[0070] In step 504, the user identifies at least one desired
stimulation effect or undesired stimulation side effect. In at
least some embodiments, the user can select from a list of
stimulation effects or stimulation side effects. In other
embodiments, the user may input an effect or side effect and the
system may correlate the input with a list of effects or side
effects.
[0071] In step 506, the system identifies a desired stimulation
region using the one or more functional maps based on the at least
one selected stimulation effect or simulation side effect. For
example, a stimulation region for a tremor-dominant patient might
be selected by choosing voxels with a high probability of tremor
improvement above a certain probability threshold, with the most
probable voxels for achieving that improvement automatically
selected and labeled as part of the desired stimulation region. In
at least some embodiments, the user or system could combine
numerous voxels with the desired clinical effects and exclude
voxels with having a likelihood above a threshold likelihood (for
example, at least 10, 20, 25, 50, or 75 percent) of side effects
(in general or specifically selected side effects) to generate the
desired stimulation region.
[0072] In step 508, the desired stimulation region is compared to
multiple estimated stimulation regions. The system may utilize any
number of estimated stimulation regions, such as at least 10, 25,
50, 100, 200, or 500 estimated stimulation regions. These estimated
stimulation regions are each associated with a set of stimulation
parameters and can be determined using any method of calculation or
estimation, including those disclosed in the references cited
above, using the corresponding set of stimulation parameters. In at
least some embodiments, the desired stimulation region can be
compared to one or more estimated stimulation regions that are
calculated or estimated after selection of the desired stimulation
region. In at least some embodiments, the estimated stimulation
regions can be predetermined prior to the selection of the desire
stimulation region or prior to any other step in this method.
[0073] In at least some embodiments, the estimated stimulation
regions are estimated or determined with respect to the lead and
then those estimated stimulation regions are registered to the
anatomical or physiological atlas, images, or the desired
stimulation region based on the position or orientation of the lead
within the patient. In at least some embodiments, the comparisons
between the desired stimulation regions and the multiple estimated
stimulation regions include, for example, a quantitative
determination of the fit of the identified stimulation region with
one or more of the estimated stimulation regions.
[0074] In some embodiments, the system can reject an estimated
stimulation region that fails to have a predetermined amount or
percentage of overlap with the identified stimulation region. In
some embodiments, the system can reject an estimated stimulation
region that fails to overlap with a predetermined amount or
percentage of the identified stimulation region. The system may
include other threshold determinations or, in at least some
embodiments, the user may select one or more threshold
requirements.
[0075] The comparison may include reporting comparative information
on a display or other device to the user. Such comparative
information can include one or more of, for example, the amount or
percentage coverage of the desired stimulation region by the
estimated stimulation region, the amount or percentage of the
desired stimulation region that is outside the estimated
stimulation region, the amount or percentage of the estimated
stimulation region that covers the desired stimulation region, the
amount or percentage of the estimated stimulation region that is
outside the desired stimulation region, other anatomical or
physiological structures that may be stimulated by the estimated
stimulation region, or the like. Alternatively or additionally, the
desired stimulation region and the estimated stimulation region can
be displayed to illustrate the overlap between the two. In some
embodiments, the system may only report comparative information on
one or more, but less than all, of the estimated stimulation
regions or display only one or more, but less than all, of the
estimated stimulation regions. The selection of which estimated
stimulation regions to include in the report or display may be by
the best fit or other criteria that the system or user
determines.
[0076] In step 510, one of the estimated stimulation regions is
selected based on the comparisons. In some embodiments, one of the
estimated stimulation regions is selected by a user, preferably
based on comparative information provided by the system to the
user. In some embodiments, one of the estimated stimulation regions
is selected by the system based on the comparisons. In at least
some embodiments, the user can set selection criteria such as, for
example, one or more thresholds for overlap, non-overlap, and the
like and may provide rules or criteria for selecting among
estimated stimulation regions that meet the thresholds, such as
priority selection factor(s) or weighting of comparative
information. As an example, the system may determine a
"goodness-of-fit" based on the difference between the desired
stimulation region and the estimated stimulation region and the
system selects the estimated stimulation region with the best
"goodness-of-fit". In some of these embodiments, the system may
allow the user to override the automatic selection by the system so
that the user can select another estimated stimulation region.
[0077] In step 512, stimulation parameters for the selected
estimated stimulation region are provided to the user or directly
to an implantable pulse generator, external trial stimulator, or
other device that generates the electrical stimulation. These
parameters can be provided by a wired connection, a wireless
connection, or in any other suitable manner. In some embodiments,
the system may allow a user to modify the stimulation
parameters.
[0078] FIG. 6 is a flowchart illustrating one method for
determining a set of stimulation parameters based on a user- or
system-selected stimulation region utilizing information regarding
synchronous neural activity. It has been found that stimulating
subpopulations of neurons that exhibit synchronous neural activity
can be used to treat a disease or disorder associated with the
synchronous neural activity. U.S. Pat. Nos. 8,000,794 and 8,280,514
and U.S. Provisional Patent Applications Ser. Nos. 62/053,414;
62/053, 427; 62/053,501; 62/053,509; and 62/053,589, all of which
are incorporated herein by reference, describe methods of
performing such stimulation. In at least some embodiments, the
stimulation of different subpopulations of neurons can eliminate or
reduce the synchronous neural activity. In at least some instances,
the stimulation can produce a coordinated reset of the neural
subpopulations.
[0079] In step 602, one or more regions of synchronous neural
activity are determined. For example, local field potentials (LFPs)
could be measured to map a region of synchronous neural activity,
such as pathological coupling of oscillations in different regions
of the brain. In other embodiments, the region of synchronous
neural activity may be estimated by observation of patient symptoms
or using information from other patients. In at least some
embodiments, at least one image of an anatomical or physiological
region of a patient is received. The image can be any suitable
image such as a Mill, CT, ultrasound, or other image. At least one
image preferably also includes an implanted electrical stimulation
lead within the image so that the position of the lead relative to
the patient tissue can be identified. In at least some embodiments,
more than one image can be received. For example, in one
embodiment, a MRI image of an anatomical or physiological region,
such as the brain or spinal cord or other organ, can be obtained to
show soft tissue portions of the region. A CT scan can also be
obtained for the anatomical or physiological region with the
electrical stimulation lead implanted to identify the position and
orientation of the lead. In at least some embodiments, the two or
more images may be registered with each other.
[0080] In some embodiments, the regions of synchronous neural
activity can then be registered to the at least one image of the
patient. Alternatively or additionally, the at least one image of
the patient of the regions of synchronous neural activity can be
registered to an anatomical or physiological atlas.
[0081] In step 604, one of the anatomical or physiological regions,
if there is more than one, determined in step 602 or a portion of
the anatomical or physiological region is selected. The selection
may be made by a user or can be automatically made by the
system.
[0082] In step 606, the selected anatomical or physiological region
is divided into multiple subregions. In at least some embodiments,
the subregions do not overlap. In other embodiments, the subregions
may overlap by no more than a threshold percentage, such as, for
example, 1, 5, 10, or 25% in volume.
[0083] In step 608, the identified subregions are each compared to
multiple estimated stimulation regions. The system may utilize any
number of estimated stimulation regions, such as at least 10, 25,
50, 100, 200, or 500 estimated stimulation regions. These estimated
stimulation regions are each associated with a set of stimulation
parameters and can be using any method of calculation or
estimation, including those disclosed in the references cited
above, using the corresponding set of stimulation parameters. In at
least some embodiments, the desired stimulation region can be
compared to one or more estimated stimulation regions that are
calculated or estimated after selection of the subregions. In at
least some embodiments, the estimated stimulation regions can be
predetermined prior to the selection of the desire stimulation
region or prior to any other step in this method.
[0084] In at least some embodiments, the estimated stimulation
regions are estimated or determined relative to the lead and then
those estimated stimulation regions are registered to the
anatomical or physiological region and the identified subregions
based on the position and orientation of the lead within the
patient. The comparison include, for example, a quantitative
determination of the fit of the subregions with each of the
estimated stimulation regions. In some embodiments, the system can
reject an estimated stimulation region that fails to have a
predetermined amount or percentage of overlap with the subregion.
In some embodiments, the system can reject an estimated stimulation
region that fail to overlap with a predetermined amount or
percentage of the subregion.
[0085] The comparison may include reporting comparative information
on a display or other device to the user. Such comparative
information can include one or more of, for example, the amount or
percentage coverage of the subregion by the estimated stimulation
region, the amount or percentage of the subregion that is outside
the estimated stimulation region, the amount or percentage of the
estimated stimulation region that covers the subregion, the amount
or percentage of the estimated stimulation region that is outside
the subregion, or the like. Alternatively or additionally, the
subregion and the estimated stimulation region can be displayed to
illustrate the overlap between the two.
[0086] In step 610, one of the estimated stimulation regions is
selected for each subregion based on the comparison. In some
embodiments, one of the estimated stimulation regions is selected
by a user, preferably based on comparative information on the
display. In some embodiments, one of the estimated stimulation
regions is selected by the system based on the comparisons. The
user may set selection criteria including thresholds for overlap,
non-overlap, and the like and may provide rules or criteria for
selecting among estimated stimulation regions that meet the
thresholds, such as priority selection factor(s) or weighting of
comparative information. In some of these embodiments, the system
may allow the user to override the automatic selection by the
system so that the user can select another estimated stimulation
region. In at least some embodiments, the individuals estimated
stimulation regions for the subregions activate non-overlapping (or
only slightly overlapping by no more than a threshold percentage,
for example, no more than 1, 5, 10, or 25%), synchronized neuronal
populations. This can allow the user or system to generate a
desynchronizing pattern of stimulation pulses, aimed at a
coordinated reset of the synchronized neural activity.
[0087] In step 612, stimulation parameters for the selected
estimated stimulation region for each subregion are provided to the
user or directly to an implantable pulse generator, external trial
stimulator, or other device that generates the electrical
stimulation. These parameters can be provided by a wired
connection, a wireless connection, or in any other suitable
manner.
[0088] It will be understood that the system can include one or
more of the methods described hereinabove with respect to FIGS. 4-6
in any combination. The methods, systems, and units described
herein may be embodied in many different forms and should not be
construed as limited to the embodiments set forth herein.
Accordingly, the methods, systems, and units described herein may
take the form of an entirely hardware embodiment, an entirely
software embodiment or an embodiment combining software and
hardware aspects. The methods described herein can be performed
using any type of processor or any combination of processors where
each processor performs at least part of the process.
[0089] It will be understood that each block of the flowchart
illustrations, and combinations of blocks in the flowchart
illustrations and methods disclosed herein, can be implemented by
computer program instructions. These program instructions may be
provided to a processor to produce a machine, such that the
instructions, which execute on the processor, create means for
implementing the actions specified in the flowchart block or blocks
disclosed herein. The computer program instructions may be executed
by a processor to cause a series of operational steps to be
performed by the processor to produce a computer implemented
process. The computer program instructions may also cause at least
some of the operational steps to be performed in parallel.
Moreover, some of the steps may also be performed across more than
one processor, such as might arise in a multi-processor computer
system. In addition, one or more processes may also be performed
concurrently with other processes, or even in a different sequence
than illustrated without departing from the scope or spirit of the
invention.
[0090] The computer program instructions can be stored on any
suitable computer-readable medium including, but not limited to,
RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM,
digital versatile disks ("DVD") or other optical storage, magnetic
cassettes, magnetic tape, magnetic disk storage or other magnetic
storage devices, or any other medium which can be used to store the
desired information and which can be accessed by a computing
device.
[0091] The above specification provides a description of the
structure, manufacture, and use of the invention. Since many
embodiments of the invention can be made without departing from the
spirit and scope of the invention, the invention also resides in
the claims hereinafter appended.
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