U.S. patent application number 17/098174 was filed with the patent office on 2021-05-20 for a planning and/or control system for a neuromodulation system.
This patent application is currently assigned to ONWARD Medical B.V.. The applicant listed for this patent is ONWARD Medical B.V.. Invention is credited to Jurriaan BAKKER, Robin BROUNS, Miroslav CABAN.
Application Number | 20210149552 17/098174 |
Document ID | / |
Family ID | 1000005262455 |
Filed Date | 2021-05-20 |
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United States Patent
Application |
20210149552 |
Kind Code |
A1 |
BROUNS; Robin ; et
al. |
May 20, 2021 |
A PLANNING AND/OR CONTROL SYSTEM FOR A NEUROMODULATION SYSTEM
Abstract
A planning and/or control system for a system for providing
neuromodulation, especially neurostimulation, at least comprising:
a graphical presentation module configured and arranged for
providing graphical information about an electrode array comprising
multiple electrodes and/or an implantation side for the electrode
array comprising at least one target area, a selection module
configured and arranged for determining a stimulation zone and/or a
stimulation direction on the electrode array comprising at least
one electrode and/or for individually selecting at least one
electrode and/or for selecting at least one target area, a
calculation module configured and arranged for determining a
contribution of currents provided by electrodes of the stimulation
zone and/or stimulation direction on the electrode array and/or the
at least one electrode selected and/or to the at least one target
area selected.
Inventors: |
BROUNS; Robin; (Eindhoven,
NL) ; BAKKER; Jurriaan; (Eindhoven, NL) ;
CABAN; Miroslav; (Renens, CH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ONWARD Medical B.V. |
Eindhoven |
|
NL |
|
|
Assignee: |
ONWARD Medical B.V.
Eindhoven
NL
|
Family ID: |
1000005262455 |
Appl. No.: |
17/098174 |
Filed: |
November 13, 2020 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/0551 20130101;
G06F 3/0488 20130101; G06F 3/04847 20130101; A61N 1/36128 20130101;
G16H 40/63 20180101; A61N 1/37247 20130101; G06F 3/0482 20130101;
G16H 20/30 20180101; A61N 1/36062 20170801 |
International
Class: |
G06F 3/0484 20060101
G06F003/0484; G06F 3/0482 20060101 G06F003/0482; A61N 1/05 20060101
A61N001/05; A61N 1/36 20060101 A61N001/36; A61N 1/372 20060101
A61N001/372; G16H 20/30 20060101 G16H020/30; G16H 40/63 20060101
G16H040/63 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 19, 2019 |
EP |
19209911.7 |
Claims
1. A planning and/or control system for a system for providing
neuromodulation, comprising: a graphical presentation module
configured and arranged for providing graphical information about
an electrode array comprising multiple electrodes and/or an
implantation side for the electrode array comprising at least one
target area, a selection module configured and arranged for
determining a stimulation zone and/or a stimulation direction on
the electrode array comprising at least one electrode and/or for
individually selecting at least one electrode and/or for selecting
at least one target area, a calculation module configured and
arranged for determining a contribution of currents provided by
electrodes of the stimulation zone and/or stimulation direction on
the electrode array and/or the at least one electrode selected
and/or to the at least one target area selected.
2. The system according to claim 1, wherein the graphical
presentation module is configured and arranged for providing
graphical information about the electrode array comprising actual
physical electrodes and/or virtual electrodes.
3. The system according to claim 2, wherein the calculation module
is configured and arranged for determining an equal contribution of
currents provided by the electrodes of the stimulation zone (Z)
and/or stimulation direction and/or the one or more electrodes
individually selected and/or to the at least one target area
selected.
4. The system according to claim 2, wherein the calculation module
is configured and arranged for determining a weighted contribution
of provided by the electrodes of the stimulation zone and/or
stimulation direction and/or the one or more electrodes
individually selected and/or to the at least one target area
selected.
5. The system according to claim 4, wherein the calculation module
is configured and arranged for determining the weighted
contribution of currents provided by the electrodes of the
stimulation zone and/or stimulation direction by calculating a
Euclidean distance from an electrode to the stimulation zone and/or
stimulation direction and/or to at least one point of the
stimulation zone and/or stimulation direction.
6. The system according to claim 4, wherein the calculation module
is configured and arranged for determining the weighted
contribution of currents provided by the electrodes of the
stimulation zone and/or the stimulation direction and/or at least
one electrode individually selected based on a generated field of
neighbor electrodes.
7. The system according to claim 4, wherein the calculation module
is configured and arranged for determining the weighted
contribution of currents provided by the electrodes of the
stimulation zone and/or the stimulation direction and/or the at
least one electrode individually selected and/or to the at least
one target area selected by a numerical method.
8. The system according to one of claim 1, wherein the system
further comprises at least one of a display, a controller, a
programmer, a communication module, a telemetry module, a
stimulation device, an electrode, a sensor and/or a sensor
network.
9. The system according to claim 1, wherein the system further
comprises at least one computer-assisted module configured and
arranged for at least partially automatically determining a
stimulation zone and/or a stimulation direction on the electrode
array comprising at least one electrode and/or for at least
partially automatically selecting at least one electrode.
10. The system according to claim 7, wherein the calculation module
is be configured and arranged to feature an algorithm to determine
the weighted contribution of currents to a benefit of power
efficiency.
11. A method for planning neuromodulation comprising the steps of:
providing graphical information about an electrode array comprising
multiple electrodes and/or an implantation side for the electrode
array comprising at least one target area, determining a
stimulation zone and/or a stimulation direction on the electrode
array comprising at least one electrode and/or individually
selecting at least one electrode and/or selecting at least one
target area, determining a contribution of currents provided by
electrodes of the stimulation zone and/or the stimulation direction
on the electrode array and/or the at least one electrode selected
and/or to at least one selected target area.
12. The method according to claim 11, wherein the graphical
information about the electrode array comprises actual physical
electrodes and/or virtual electrodes.
13. The method according to claim 12, wherein the method further
comprises a step of determining an equal contribution of currents
provided by the electrodes of the stimulation zone and/or the
stimulation direction and/or at least one electrode individually
selected and/or to the at least one target area selected.
14. The method according to claim 12, wherein the method further
comprises a step of determining a weighted contribution of currents
provided by the electrodes of the stimulation zone and/or the
stimulation direction and/or at least one electrode individually
selected and/or to the at least one target area selected.
15. The method according to claim 14, wherein the method further
comprises the step of determining the weighted contribution of
currents provided by the electrodes of the stimulation zone and/or
the stimulation direction by calculating a Euclidean distance from
an electrode to the stimulation zone and/or the stimulation
direction and/or to at least one point of the stimulation zone
and/or at least one stimulation direction.
16. The method according to claim 14, wherein the method further
comprises the step of determining the weighted contribution of
currents provided by the electrodes of the stimulation zone and/or
the stimulation direction and/or the at least one electrode
individually selected based on a generated field of neighbor
electrodes.
17. The method according to claim 14, wherein the method further
comprises the step of determining the weighted contribution of
currents provided by the electrodes of the stimulation zone and/or
the stimulation direction and/or at least one electrode
individually selected and/or to the at least one target area
selected by a numerical method.
18. The method according to claim 10, wherein the method further
comprises the step of least partially automatically determining a
stimulation zone and/or a stimulation direction on the electrode
array comprising at least one electrode and/or for at least
partially automatically selecting at least one electrode.
19. The method according to claim 18, wherein the method further
comprises the step of featuring an algorithm to determine the
weighted contribution of currents to the benefit of power
efficiency.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] The present application claims priority to European Patent
Application No. 19209911.7, entitled "A PLANNING AND/OR CONTROL
SYSTEM FOR A NEUROMODULATION SYSTEM", and filed on Nov. 19, 2019.
The entire contents of the above-listed application is hereby
incorporated by reference for all purposes.
TECHNICAL FIELD
[0002] The present invention relates to control systems for tissue
stimulating systems, in particular a planning and/or control system
for a system for providing neuromodulation, especially
neurostimulation for a patient.
BACKGROUND AND SUMMARY
[0003] The present invention further relates to a method for
planning neuromodulation, especially neurostimulation for a
patient.
[0004] The spinal cord is an integral part of the central nervous
system (CNS). Spinal cord injury (SCI), but also other disorders
(e.g. stroke, multiple sclerosis, autonomic failure, autonomic
neuropathy or cancer of the neurological tissue which impair
operation of descending sympathetic pathways that normally
facilitate control of autonomic functions) result in motor
deficits. For instance, SCI interrupts the communication between
the spinal cord and supraspinal centres, depriving these
sensorimotor circuits from the excitatory and modulatory drives
necessary to produce movement. However, SCI also results in sensory
deficits and in autonomic dysfunctions. In particular, SCI results
in disconnection of some, most, or all descending sympathetic
pathways that carry signals responsible for regulating arterial
blood pressure, heart rate and/or gut and/or bladder function.
[0005] Spinal cord stimulation (SCS) is a well-established
neuromodulatory therapy not only for restoring locomotion/motoric
function after spinal cord injury or central nervous diseases, but
also for treating inter alia pain and/or restoring autonomic
function.
[0006] Neuromodulation, in particular neurostimulation, in
particular SCS is typically applied to a subject by a
neuromodulation system comprising at least one electrode array
comprising at least one electrode. Neuromodulation systems may
further comprise at least one of a controller, e.g. a
microcontroller, a processor, e.g. a microprocessor, a pulse
generator, in particular an implantable pulse generator, a sensor,
a communication module, a telemetry module.
[0007] The electrode array, e.g. comprised in a lead paddle, can be
applied for percutaneous electrical stimulation, transcutaneous
electrical nerve stimulation (TENS), epidural electrical
stimulation (EES), subdural electrical stimulation (SES),
functional electrical stimulation (FES) and/or all neurostimulation
and/or muscle stimulation applications that use at least one
electrode array and/or at least one electrode.
[0008] Lead paddles are for example known from U.S. Pat. No.
8,108,051B2, US 2013/0096662 A1, US 2012/0006793A1 and
EP3013411A1.
[0009] A neuromodulation system, especially a neuro stimulation
system for a patient suffering from motoric dysfunction and/or
autonomic dysfunction requires programming to define which
stimulation settings need to be used to evoke certain muscles or
muscle groups. Such muscles and/or muscle groups may be responsible
for locomotion of the arms or legs, and/or responsible for e.g.
bowel movement, sphincter control, bladder control and/or sexual
function. Such programming of stimulation parameters may be
performed by a user, such as a clinical professional, a
physiotherapist and/or the patient himself, and facilitated by a
computer-driven application. Neurostimulation, in particular
multi-channel and/or variable neurostimulation often requires an
interface to create the stimulation program and a stimulation
system to deliver the stimulation. A user selects specific
electrodes via a user interface on which he would like to perform
stimulation for a patient who's implanted with the lead comprising
the electrode array.
[0010] EP3527258A1 discloses a system for an electrical
neurostimulator coupled to a plurality of electrodes, comprising: a
user-controlled input device configured for generating directional
control signals; and control circuitry configured for sequentially
defining a plurality of different ideal bipole/tripole
configurations relative to the plurality of electrodes in response
to the directional control signals, generating a plurality of
stimulation parameter sets respectively corresponding to the
plurality of ideal bipole/tripole configurations, each stimulation
parameter set defining relative amplitude values for the plurality
of electrodes that emulate the respective ideal bipole/tripole
configuration, and instructing the electrical neurostimulator to
convey electrical energy to the plurality of electrodes in
accordance with the plurality of stimulation parameter sets.
[0011] EP3285855B1 discloses a system for delivering
neurostimulation including a programming control circuit and a user
interface. The programming control circuit may be configured to
generate stimulation parameters controlling delivery of
neurostimulation pulses according to one or more stimulation
waveforms associated with areas of stimulation each defined by a
set of electrodes. The neurostimulation pulses are each delivered
to an area of stimulation. The user interface may include a display
screen and an interface control circuit. The interface control
circuit may be configured to define the one or more stimulation
waveforms and the areas of stimulation and may include a
stimulation frequency module configured to display a stimulation
rate table on the display screen. The stimulation rate table may
present stimulation frequencies associated with each of the areas
of stimulation for selection by a user.
[0012] Currently, leads comprising an electrode array comprising
multiple electrodes with an intended use for neuromodulation offer
a limited range of freedom since their resolution is confined by
the number of electrodes. Options such as unipolar and multipolar
stimulation increase field-steering capabilities, but the user is
still limited by the fixed set of electrodes that he or she can
pick from.
[0013] Therefore, the present disclosure provides a neuromodulation
system which allows increasing neuromodulation options on a lead
comprising an electrode array comprising electrodes.
[0014] This increasing of the neuromodulation options may be solved
according to the present invention by a planning and/or control
system for a system for providing neuromodulation, especially
neurostimulation, at least comprising:
[0015] a graphical presentation module configured and arranged for
providing graphical information about an electrode array comprising
multiple electrodes and/or an implantation side for the electrode
array comprising at least one target area,
[0016] a selection module configured and arranged for determining a
stimulation zone and/or a stimulation direction on the electrode
array comprising at least one electrode and/or for individually
selecting at least one electrode and/or for selecting at least one
target area,
[0017] a calculation module configured and arranged for determining
a contribution of currents provided by electrodes of the
stimulation zone and/or stimulation direction on the electrode
array and/or the at least one electrode selected and/or to the at
least one target area selected.
[0018] The invention is based on the basic idea that the amount of
stimulation options and/or stimulation resolution of a lead
comprising an electrode array may be increased by using the concept
of electrode and/or current weighting. Thus, the options for
choosing stimulation options may no longer be constricted by
selecting discrete electrodes (that means separate electrodes or
one or more single electrode(s)) on a lead and/or electrode array
but leverages the wide freedom of current weighting/balancing and
presenting this in an intuitive way to a user using the system.
Alternatively, and/or additionally, combining stimulation options
with imaging may allow a user to create a root for stimulation or
steering current to more naturally stimulate nerves rather than
creating homogenous fields. The use of a general concept including
a graphical presentation module, a selection module and a
calculation module combined into one strategy and made available
for a system for providing neuromodulation, especially
neurostimulation may enable to reduce limitations of stimulation
options with current leads and/or electrode arrays and enable that
the patient may receive best possible stimulation.
[0019] In particular, the system may use anatomical information
about the dorsal root trajectory, to adapt the weighing of
electrode currents, to steer the field, such (parallel to the
trajectories) that maximum activation is obtained at target roots,
while avoiding activation of the non-targeted roots.
[0020] The graphical presentation module may provide graphical
information about an electrode array comprising actual physical
electrodes and/or virtual electrodes. In particular, actual
physical electrodes may reflect actual physical electrodes of a
corresponding neuromodulation system related to the system for
planning and/or control system. In particular, virtual electrodes
may be represented by the graphical presentation module of the
system only and may not reflect actual physical electrodes of a
corresponding neuromodulation system related to the panning and/or
control system according to the present invention. In other words,
virtual electrodes may be introduced by the system without
physically introducing more. In particular, any number of virtual
electrodes may be introduced in addition to the actual physical
electrodes. In particular, virtual electrodes presented to a user
may be more understandable and graspable than current-weighting or
current-steering in percentages or absolute numbers. Overall, this
enhances the options for choosing stimulation options.
[0021] In particular, each virtual and/or physical electrode may be
controlled independently. In particular, this may enable that each
virtual and/or physical electrode may be characterized by a
different frequency and/or waveform.
[0022] In particular, the user may be e.g. a therapist, a
physiotherapist, a physician, a trainer, a medical professional, a
patient and/or any person related to the patient.
[0023] In particular, the target area may be or may comprise
fictious and/or realistic anatomical conditions of a mammal, in
particular a human being, such as the patient himself or a healthy
individual. In particular, the target area may be or may comprise
at least one target nerve and/or nerve fiber and/or dorsal root
and/or area of the spinal cord and/or tissue and/or area related to
the spinal cord and/or muscle fiber and/or muscle.
[0024] In particular, the target area could be augmented with an
approximate neuronal model, e.g. neuronal fibers passing through
dorsal roots. In particular, the system may enable to calculate
contribution of currents based on neuronal simulations and/or
anatomical conditions.
[0025] The selection module may be or may comprise a user
interface. In particular, the user interface may be a graphical
user interface. In particular, the selection module may be an input
module. The selection module may comprise a mouse and/or a
trackball and/or a joystick, a display and/or a touch screen and/or
a touch pad and/or an acoustic signal and/or acoustic tone and/or a
verbal command input. In particular, the selection module may be
configured and arranged for allowing a user to actuate at least one
control element, including but not limited to axes, points, knots,
buttons, arrows, hand signals, emojis, crosses and/or windows
and/or text and/or shortcuts in order to modify graphical
information.
[0026] In particular, the selection module may enable to select
information and/or links and/or strategies provided by the
graphical presentation module.
[0027] In particular, the stimulation zone may be or may comprise
an area on a lead and/or electrode array comprising multiple
electrodes, wherein the area comprises at least one electrode.
[0028] In particular, a stimulation zone may also be or may
comprise a stimulation vector and/or a stimulation direction and/or
at least one single electrode.
[0029] The calculation module may be or may comprise at least one
algorithm. In particular, the calculation module may translate a
selected stimulation zone and/or stimulation direction and/or the
one or more electrodes individually selected and/or the at least
one target area selected into a certain weighting, such as current
weighting, on a real electrode array comprising electrodes, for
stimulating a patient.
[0030] The calculation module may be configured and arranged for
determining an equal contribution of currents provided by the
electrodes of the stimulation zone and/or stimulation direction
and/or the one or more electrodes individually selected and/or to
the at least one target area selected. In particular, a user may
select a stimulation zone and/or a stimulation direction and/or one
or more electrodes individually and current sourcing may be
distributed equally over all electrodes and/or anodes selected.
Alternatively, and/or additionally, a user may select at least one
target area and current sourcing may be distributed equally over
the electrodes located at the at least one target area. In
particular, this has the advantage that differences in excitation
and/or excitability of different target nerves during equal
stimulation may identified, which finally may enable optimizing
stimulation protocols.
[0031] The calculation module may be configured and arranged for
determining a weighted contribution of currents provided by the
electrodes of the stimulation zone and/or stimulation direction
and/or the at least one electrode individually selected and/or to
the at least one target area selected. Overall, weighted
contribution of currents, compared to homogenous fields, may enable
more effective and closer to natural stimulation. In particular,
weighted contribution may enable to direct a current to overcome
neurological activity thresholds in an optimized matter. In
particular, the second spatial derivative, tangential to a
neuron/nerve may be the driving force behind activation. A simple
field normal to a fiber may not lead to predictive activation, yet
a tangent directional field may do.
[0032] In particular, for a stimulation direction, such as a
stimulation vector, the weighting of electrodes may comprise
distance and/or direction, in particular with the origin of the
stimulation direction as the reference.
[0033] The calculation module may be configured and arranged for
determining the weighted contribution of currents provided by the
electrodes of the stimulation zone and/or stimulation direction by
calculating the Euclidean distance from an electrode to the
stimulation zone and/or stimulation direction and/or to at least
one point of the stimulation zone and/or stimulation direction.
[0034] In particular, the Euclidean distance may be the ordinary
distance between two points, here two electrodes and/or points of
two electrodes. In particular, it may be the straight-line distance
between two points and/or two electrodes and/or two points of
electrodes. In particular, in a stimulation zone comprising more
than two electrodes, this may have the advantage that the distance
and the weighting of two electrodes is not affected by the addition
of a third electrode to the analysis. Overall, weighting of each
electrode of a stimulation zone and/or stimulation direction, based
on the absolute and/or relative distance of the respective
electrode of the stimulation zone and/or stimulation direction to
one point of the stimulation zone and/or stimulation direction may
be enabled. This may enable that e.g. decreased stimulation
intensity is provided, the farer an electrode of the stimulation
zone is from a specific stimulation center of a stimulation zone.
This may enable close to natural stimulation.
[0035] In particular, the Euclidean distance may be the ordinary
distance between two points, here e.g. two nerves and/or nerve
fibers and/or parts of nerves and/or parts of nerve fibers of at
least one target area. In particular, it is the straight-line
distance between e.g. two nerves and/or nerve fibers and/or parts
of nerves and/or parts of nerve fibers of at least one target area.
Overall, weighting of nerves and/or nerve fibers and/or parts of
nerves and/or parts of nerve fibers of at least one target area,
based on the absolute and/or relative distance of the respective
nerve and/or nerve fiber and or part of a nerve and/or part of a
nerve fiber of the of the target area to one point of the target
area may be enabled. This may enable that e.g. decreased
stimulation intensity is provided, the farer a nerve and/or nerve
fiber and/or part of nerve and/or part of nerve fiber of at least
one target area is from a specific stimulation center of a target
area. This may enable close to natural stimulation.
[0036] The calculation module may be configured and arranged for
determining the weighted contribution of currents provided by the
electrodes of the stimulation zone and/or the stimulation direction
and/or at least one electrode individually selected based on a
generated field of neighbor electrodes. In particular, this may
enable soft transitions of the current strengths of adjacent
electrodes. Overall, this may enable close to natural
stimulation.
[0037] The calculation module may be configured and arranged for
determining the weighted contribution of currents provided by the
electrodes of the stimulation zone and/or the stimulation direction
and/or the at least one electrode individually selected and/or to
the at least one target area selected by a numerical method. In
particular, this approach may enable using a personalized patient
model comprising the targeted and unwanted nerve locations
(crosstalk), and which has computed for N electrode configurations
the 3D potential distributions, as well as the activation
potentials and/or selectivity indices. In particular, based on the
stimulation zone and/or the stimulation direction and/or the at
least one electrode individually selected and/or the at least one
target area selected the numerical method may optimize the
weighting of electrode intensities for maximizing a selectivity
index, or for maximizing the target while minimizing sensitive
areas. Overall, this may enable stimulation adapted to patient
specific needs, i.e. patient specific stimulation.
[0038] In principle, it may be additionally and/or alternatively
possible that different frequencies and/or pulse with are applied
to different electrodes to create a stimulation zone. In
particular, a user may select a certain zone and intends it to have
130 Hz stimulation, which may then be achieved by delivering
differing stimulation frequencies to its surrounding electrodes,
and the frequency of 130 Hz in the stimulation zone may be achieved
by amplification (overlapping, or constructive interference) or
cancellation interference.
[0039] Further, the system may decide for which intended
muscles/roots, a certain waveform should be used, e.g. a low
frequency, a higher frequency, or a burst (e.g.
triplets/quadruplets, with different burst frequency) waveform. In
this case, the system may use knowledge of neurophysiology, i.e.
which muscles (agonists/antagonists) and/or roots to determine if a
higher frequency, or a burst frequency is required to increase
activation of target muscles and/or roots, while keeping unwanted
muscles and/or roots less exposed.
[0040] The calculation module may be configured and arranged to
feature an algorithm to determine the weighted contribution of
currents to the benefit of power efficiency. This algorithm may be
appended to any of the previously mentioned calculation module
implementations. This algorithm may interpret the input weighted
electrode configuration and optimize it such that a new
configuration is created that creates a considerably similar
electrical field with the same effect on the effectuated neural
tissue, yet with better power efficiency. In particular, with the
increased stimulation freedom offered to the system by the `Virtual
Electrodes` concept, the search-space for more power-efficient
settings to the algorithm is also increased. In addition to the
algorithm altering the current weighting, the algorithm may further
achieve power-efficiency effects by combining this with reduction
or increase of the amount of allocated electrodes (to reduce
impedance), or may update the required stimulation current or total
charge required to achieve the neurostimulation.
[0041] The system may further comprise at least one
computer-assisted module configured and arranged for at least
partially automatically determining a stimulation zone and/or a
stimulation direction on the electrode array comprising at least
one electrode and/or for at least partially automatically selecting
at least one electrode, optionally based on medical imaging
superimposing. In particular, medical images may be obtained by
MRI, CT, X-Ray, photography, etc. Alternatively, and/or
additionally, anatomical models could be used. In particular, this
may enable finding optimal zones and/or targets for stimulation,
specifically adapted to the patient's anatomy and needs.
[0042] In other words, in general, the stimulation direction and/or
stimulation zone on an electrode array comprising at least one
electrode may be either selected manually by a user or
automatically or semi-automatically by identifying a target area
from anatomical data.
[0043] So, especially the following use-case is possible: On the
visualization of the electrode overlapped on the anatomical model
(with roots visible), we should be able to draw the stimulation
zone (and direction) desired in order to target the roots of
interest.
[0044] Furthermore this zone could be determined automatically if a
software identifies the roots automatically from the anatomical
model (e.g. MRI).
[0045] The system may further comprise at least one of a display, a
controller, a programmer, a communication module, a telemetry
module, a stimulation device, an electrode, a sensor and/or a
sensor network.
[0046] In particular, the system may be a closed-loop system or an
open-loop system.
[0047] It is also possible that the system allows both closed-loop
or open loop functionality. In this regard, the user may switch
between these options or there may be routines or control elements
that can do or propose such a switch from closed-loop to open-loop
and vice versa.
[0048] In particular, the system may be related to a system for
providing neuromodulation, in particular neurostimulation to a
patient. The system for providing neuromodulation, in particular
neurostimulation to a patient may comprise at least one of a
controller, a programmer, a communication module, a telemetry
module, a stimulation device comprising an electrode array
comprising multiple electrodes, a sensor and/or a sensor
network.
[0049] According to the present invention a method is disclosed,
the method being performed with the system described above.
[0050] In particular, a method for planning neuromodulation,
especially neurostimulation, may comprise at least the steps
of:
providing graphical information about an electrode array comprising
multiple electrodes and/or an implantation side for the electrode
array comprising at least one target area, determining a
stimulation zone and/or a stimulation direction on the electrode
array comprising at least one electrode and/or individually
selecting at least one electrode and/or selecting at least one
target area, determining a contribution of currents provided by
electrodes of the stimulation zone on the electrode array and/or
the at least one electrode selected and/or to the at least one
selected target area.
[0051] In particular, the graphical information about the electrode
array may comprise actual physical electrodes and/or virtual
electrodes.
[0052] The method may further comprise the step of determining an
equal contribution of currents provided by the electrodes of the
stimulation zone and/or the stimulation direction and/or at least
one electrode individually selected and/or to the at least one
target area selected.
[0053] In particular, the method may further comprise the step of
determining a weighted contribution of currents provided by the
electrodes of the stimulation zone and/or the stimulation direction
and/or at least one electrode individually selected and/or to the
at least one target area selected.
[0054] The method may further comprise the step of determining the
weighted contribution of currents provided by the electrodes of the
stimulation zone and/or the stimulation direction by calculating
the Euclidean distance from an electrode to the stimulation zone
and/or the stimulation direction and/or to at least one point of
the stimulation zone and/or stimulation direction.
[0055] The method may further comprise the step of determining the
weighted contribution of currents provided by the electrodes of the
stimulation zone and/or the stimulation direction and/or the at
least one electrode individually selected based on a generated
field of neighbor electrodes.
[0056] The method may further comprise the step of determining the
weighted contribution of currents provided by the electrodes of the
stimulation zone and/or the stimulation direction and/or at least
one electrode individually selected and/or to the at least one
target area selected by a numerical method.
[0057] The method may further comprise the step of least partially
automatically determining a stimulation zone and/or a stimulation
direction on the electrode array comprising at least one electrode
and/or for at least partially automatically selecting at least one
electrode, optionally based on medical imaging superimposing.
[0058] The method may further comprise the step of featuring an
algorithm to determine the weighted contribution of currents to the
benefit of power efficiency.
BRIEF DESCRIPTION OF THE FIGURES
[0059] Further details and advantages of the present invention
shall now be disclosed in connection with the drawings.
[0060] It is shown in:
[0061] FIG. 1 a schematical overview of an embodiment of the
planning and/or control system for a system for providing
neuromodulation, especially neurostimulation according to the
present invention, with which the method according to the present
invention may be performed;
[0062] FIG. 2 an example of an equal contribution of currents
provided by individually selected electrodes of an electrode array,
according to the present invention;
[0063] FIG. 3 an example of weighted contribution of currents
provided by electrodes of a determined stimulation zone of an
electrode array, according to the present invention;
[0064] FIG. 4 an example of an embodiment of an electrode array,
comprising virtual electrodes, according to the present
invention;
[0065] FIG. 5 an example of determining a stimulation direction,
according to the present invention;
[0066] FIG. 6 two examples of graphical information provided by the
graphical presentation module, combining an electrode array with a
target area, according to the present invention;
[0067] FIG. 7 a further example of graphical information provided
by the graphical presentation module, combining an electrode array
with at least one possible target area, according to the present
invention; and
[0068] FIG. 8 a further example of graphical information provided
by the graphical presentation module, according to the present
invention.
DETAILED DESCRIPTION
[0069] FIG. 1 shows a schematical overview of an embodiment of the
planning and/or control system 10 for a system for providing
neuromodulation, especially neurostimulation according to the
present invention, with which the method according to the present
invention may be performed.
[0070] The system 10 comprises a graphical presentation module 12,
a selection module 14, and a calculation module 16. In some
examples, the graphical presentation module 12, the selection
module 14, and the calculation module 16 may be present on a single
device, or one or more of the graphical presentation module 12, the
selection module 14, and the calculation module 16 may be present
on separate devices. The device(s) comprising the graphical
presentation module 12, the selection module 14, and the
calculation module 16 may include memory, one or more processors,
and a communication subsystem, though other components and modules
may also be included as known to those of skill in the art. In some
aspects, the device(s) comprising the graphical presentation module
12, the selection module 14, and the calculation module 16 may be
coupled to a user input device, a display, an electrode array
comprising one or more electrodes, and/or other peripheral
components.
[0071] Collectively, the various tangible components or a subset of
the tangible components of the planning and/or control system 10
may be referred to herein as "logic" configured or adapted in a
particular way, for example as logic configured or adapted with
particular software, hardware, or firmware and adapted to execute
computer readable instructions. The processors may be single core
or multicore, and the programs executed thereon may be configured
for parallel or distributed processing. The processors may
optionally include individual components that are distributed
throughout two or more devices, which may be remotely located
and/or configured for coordinated processing. One or more aspects
of the logic subsystem may be virtualized and executed by remotely
accessible networked computing devices configured in a cloud
computing configuration, that is, one or more aspects may utilize
ubiquitous, convenient, on-demand network access to a shared pool
of configurable computing resources that can be rapidly provisioned
and released with minimal management effort or service provider
interaction. Clouds can be private, public, or a hybrid of private
and public, and may include Infrastructure as a Service (IaaS),
Platform as a Service (PaaS) and Software as a Service (SaaS). In
some aspects, logic and memory may be integrated into one or more
common devices, such as an application specific integrated circuit,
field programmable gate array, or a system on a chip.
[0072] In some embodiments, one or more of the device(s) of the
planning and/or control system 10 may be any computing or mobile
device, for example, mobile devices, tablets, laptops, desktops,
PDAs, and the like, as well as virtual reality devices or augmented
reality devices. Thus, in some embodiments, the device(s) may
include a display and thus a separate display or user input device
may not be necessary. In other aspects, the device(s) may be
coupled to a plurality of displays.
[0073] The memory generally comprises a random-access memory
("RAM") and permanent non-transitory mass storage device, such as a
hard disk drive or solid-state drive. The memory may store an
operating system as well as the various modules and components
discussed herein. It may further include devices which are one or
more of volatile, non-volatile, dynamic, static, read/write,
read-only, random access, sequential access, location addressable,
file addressable and content addressable.
[0074] The communication subsystem may be configured to
communicatively couple the modules within a device as well as
communicatively coupling a device with one or more other computing
and/or peripheral devices. Such connections may include wired
and/or wireless communication devices compatible with one or more
different communication protocols including, but not limited to,
the Internet, a personal area network, a local area network (LAN),
a wide area network (WAN) or a wireless local area network (WLAN).
For example, wireless connections may be WiFi, Bluetooth.RTM., IEEE
802.11, and the like.
[0075] In this embodiment, the graphical presentation module 12 is
configured and arranged for providing graphical information about
an electrode array A comprising multiple electrodes E, V and/or an
implantation side for the electrode array A comprising at least one
target area X.
[0076] The system 10 further comprises the selection module 14.
[0077] In this embodiment, the selection module 14 is configured
and arranged for determining a stimulation zone Z and/or a
stimulation direction D on the electrode array A comprising at
least one electrode E, V and/or for individually selecting at least
one electrode E, V and/or for selecting at least one target area
X.
[0078] The system 10 further the a calculation module 16.
[0079] In this embodiment, the calculation module 16 is configured
and arranged for determining a contribution of currents provided by
electrodes E, V of the stimulation zone Z and/or stimulation
direction D on the electrode array A and/or the at least one
electrode E, V selected and/or a to the at least one target area X
selected.
[0080] In this embodiment, the graphical presentation module 12,
the selection module 14 and the calculation module 16 are
connected.
[0081] In this embodiment, the graphical presentation module 12,
the selection module 14 and the calculation module 16 are connected
via a bidirectional connection.
[0082] In this embodiment, the graphical presentation module 12,
the selection module 14 and the calculation module 16 are connected
via a wireless link.
[0083] However, in an alternative embodiment, a unidirectional
and/or cable-bound connection between the graphical presentation
module 12, the selection module 14 and/or the calculation module 16
could be generally possible.
[0084] In this embodiment, the graphical presentation module 12
provides graphical information about an electrode array A
comprising multiple electrodes E, V.
[0085] In an alternative embodiment, the graphical presentation
module 12 could provide additionally and/or alternatively graphical
information abound an implantation side for the electrode array A
comprising at least one target area X.
[0086] Not shown in this embodiment is that the graphical
information about the implantation site could be patient-specific
data.
[0087] Not shown in this embodiment is that the graphical
information about the implantation site could be patient-specific
MRI data, X-Ray data, pictures obtained during surgery, etc.
[0088] In this embodiment, the selection module 14 determines a
stimulation zone Z.
[0089] In this embodiment, the selection module 14 determines a
stimulation zone Z based on a user input.
[0090] Not shown in this embodiment is that the selection module 14
could generally comprise a user interface.
[0091] In an alternative embodiment, the selection module 14 could
additionally and/or alternatively determine a stimulation direction
D on the electrode array A comprising at least one electrode E, V
and/or for selecting at least one target area X, based on user
input.
[0092] Not shown in FIG. 1 is that the system 10 could further
comprise at least one of a display, a controller, a programmer, a
communication module, a telemetry module, a stimulation device, an
electrode, a sensor and/or a sensor network, as described above.
For example, each of the modules described herein could be included
as part of or coupled to a controller, where the controller
includes a non-transitory memory (e.g., the memory described above)
storing instructions that are executable by a processor (e.g., the
processor described above) to perform the functions described
herein.
[0093] Not shown in this embodiment is that the graphical
presentation module 12 could in general provide graphical
information about an electrode array A comprising actual physical
electrodes E and/or virtual electrodes V.
[0094] Not shown in this embodiment is that virtual electrodes V
could be selected for stimulation.
[0095] Not shown in FIG. 1 is that virtual electrodes V may be more
understandable and graspable to the user than current-weighting or
current-steering in percentages and/or absolute numbers.
[0096] Not shown in FIG. 1 is that it could be generally possible
that the calculation module 16 could be configured and arranged for
determining an equal contribution of currents provided by the
electrodes E, V of the stimulation zone Z and/or the stimulation
direction D and/or the one or more electrodes E, V individually
selected and/or to the at least one target area X selected.
[0097] Not shown in FIG. 1 is that it could be generally possible
that the calculation module 16 could be configured and arranged for
determining a weighted contribution of currents provided by the
electrodes E, V of the stimulation zone Z and/or stimulation
direction D and/or the at least one electrode E, V individually
selected and/or to the at least one target area X selected.
[0098] Not shown in FIG. 1 is that it could be generally possible
that the calculation module 16 could be configured and arranged for
determining the weighted contribution of currents provided by the
electrodes E, V of the stimulation zone Z and/or stimulation
direction D by calculating the Euclidean distance from an electrode
E, V to the stimulation zone Z and/or stimulation direction D
and/or to at least one point of the stimulation zone Z and/or
stimulation direction D.
[0099] Further not shown in FIG. 1 is that it could be generally
possible that the calculation module 16 could be configured and
arranged for determining the weighted contribution of currents
provided by the electrodes E, V of the stimulation zone Z and/or
the stimulation direction D and/or at least one electrode E, V
individually selected based on a generated field of neighbor
electrodes E, V.
[0100] In particular, from an activation line such as a stimulation
vector and/or a stimulation direction D, it could be calculated
which neighboring electrodes E, V can create a field in this
direction and weighting factors could be determined.
[0101] Further not shown in FIG. 1 is that it could be generally
possible that the calculation module 16 could be configured and
arranged for determining the weighted contribution of currents
provided by the electrodes E, V of the stimulation zone Z and/or
the stimulation direction D and/or the at least one electrode E, V
individually selected and/or to the at least one target area X
selected by a numerical method.
[0102] In general, instead of analytical models, a numerical method
could be used, using a personalized patient model M, e.g. a MRI
based patient model M, that includes both targeted and unwanted
(cross-talk) nerve locations, and which has computed for N
electrode E, V configurations the 3D potential distributions, as
well as the activation potentials/selectivity indices.
[0103] Not shown in FIG. 1 is that the system 10 could further
comprise at least one computer-assisted module configured and
arranged for at least partially automatically determining a
stimulation zone Z and/or a stimulation direction D on the
electrode array A comprising at least one electrode E, V and/or for
at least partially automatically selecting at least one electrode
E, V, optionally based on medical imaging superimposing, cf. FIG.
6.
[0104] Not shown in FIG. 1 is that the calculation module 16 could
generally feature an algorithm to determine the weighted
contribution of currents to the benefit of power efficiency.
[0105] Based on the electrodes E, V of the stimulation zone Z
and/or the stimulation direction D and/or the at least one
electrode E, V individually selected and/or the at least one target
area X indicated by the user, the calculation module 16 could use a
(pre-computed, or online calculated) neuronal activation model, to
optimize the weighting of electrode E, V intensities for maximizing
the selectivity index, or for maximizing the target while
minimizing the sensitive areas.
[0106] In general, the system 10 could perform a method for
planning neuromodulation, especially neurostimulation, at least
comprising the steps of:
providing graphical information about an electrode array A
comprising multiple electrodes E, V and/or an implantation side for
the electrode array A comprising at least one target area X,
determining a stimulation zone Z and/or a stimulation direction D
on the electrode array A comprising at least one electrode E, V
and/or individually selecting at least one electrode E, V and/or
selecting at least one target area X, determining a contribution of
currents provided by electrodes E, V of the stimulation zone Z
and/or the stimulation direction D on the electrode array A and/or
the at least one electrode E, V selected and/or to the at least one
selected target area X.
[0107] In general, the graphical information about the electrode
array A could comprise actual physical electrodes E and/or virtual
electrodes V.
[0108] The method could further comprise the step of determining an
equal contribution of currents provided by the electrodes E, V of
the stimulation zone Z and/or the stimulation direction D and/or at
least one electrode E, V individually selected and/or to the at
least one target area X selected.
[0109] The method could further comprise the step of determining a
weighted contribution of currents provided by the electrodes E, V
of the stimulation zone Z and/or the stimulation direction D and/or
at least one electrode E, V individually selected and/or to the at
least one target area X selected.
[0110] The method could further comprise the step of determining
the weighted contribution of currents provided by the electrodes E,
V of the stimulation zone Z and/or the stimulation direction D by
calculating the Euclidean distance from an electrode E, V to the
stimulation zone Z and/or the stimulation direction D and/or to at
least one point of the stimulation zone Z and/or stimulation
direction D.
[0111] The method cold further comprises the step of determining
the weighted contribution of currents provided by the electrodes E,
V of the stimulation zone Z and/or the stimulation direction D
and/or the at least one electrode E, V individually selected based
on a generated field of neighbor electrodes E, V.
[0112] The method could further comprise the step of determining
the weighted contribution of currents provided by the electrodes E,
V of the stimulation zone Z and/or the stimulation direction D
and/or at least one electrode E, V individually selected and/or to
the at least one target area X selected by a numerical method.
[0113] The method could further comprise the step of least
partially automatically determining a stimulation zone Z and/or a
stimulation direction D on the electrode array A comprising at
least one electrode E, V and/or for at least partially
automatically selecting at least one electrode E, V, optionally
based on medical imaging superimposing.
[0114] The method could further comprise the step of featuring an
algorithm to determine the weighted contribution of currents to the
benefit of power efficiency.
[0115] In general, the weighting may be presented as absolute
numbers (e.g. in V, mA, A) and/or expressed as percentage of total
current applied by involved electrodes E, V.
[0116] Examples of how to determine a stimulation zone Z and/or
stimulation direction D and/or select individual electrodes E, V
and/or at least one target area X are disclosed in FIGS. 2, 3, 4,
5, 6, 7 and/or 8.
[0117] FIG. 2 shows an example of an equal contribution of currents
provided by individually selected electrodes E, V of an electrode
array A, determined by the calculation module 16 of the system 10
disclosed in FIG. 1.
[0118] In this embodiment, the graphical information provided by
the graphical presentation module 12 of the system 10 disclosed in
FIG. 1 comprises an electrode array A comprising 16 electrodes
E.
[0119] In this embodiment, the system 10 is connected to a system
for neuromodulation, comprising an electrode array A'.
[0120] In this embodiment, the electrode array A comprising 16
electrodes E provided by the graphical presentation module 12
reflects an electrode array A' of a related neuromodulation system
configured and arranged for providing neuromodulation to a
patient.
[0121] In this embodiment, the selection module 14 comprises a user
interface.
[0122] In this embodiment, the selection module 14 comprises a
graphical user interface.
[0123] In this embodiment, the selection module 14 is configured
and arranged for individually selecting at least one electrode E of
the electrode array A.
[0124] In this embodiment, the selection module 14 is configured
and arranged for individually selecting at least one electrode E of
the electrode array A based on a user input.
[0125] The shown embodiment is a display of a tablet computer, in
particular a touch screen.
[0126] However, in general, any display and/or touch screen and/or
programmer and/or mobile device could be possible.
[0127] In this embodiment, the display discloses the graphical
information provided by the graphical presentation module 12.
[0128] In this embodiment, the user selects electrodes E of the
electrode array A' by touching with a finger on the touch screen,
in particular on respective electrodes E of the electrode array A
on the display.
[0129] Alternatively, the electrodes E could be selected via a
mouse click.
[0130] In general, it could be possible that the electrodes E are
selected by a mouse and/or a trackball and/or a joystick, a display
and/or a touch screen and/or a touch pad and/or an acoustic signal
and/or acoustic tone and/or a verbal command input.
[0131] In general, the selection module 14 could allow a user to
actuate at least one control element, including but not limited to
axes, points, knots, buttons, arrows, hand signals, emojis, crosses
and/or windows and/or text and/or shortcuts.
[0132] In this embodiment, the user input is translated by the
calculation module 16 into a certain weighting that could then be
sent to the neuromodulation system for providing
neuromodulation.
[0133] In this embodiment, the neuromodulation provided by the
system for providing neuromodulation is modified according to the
user input.
[0134] In this embodiment, the calculation module 16 of the system
10 disclosed in FIG. 1 determines an equal contribution of currents
provided by three electrodes E individually selected.
[0135] In this embodiment, the calculation module 16 of the system
10 disclosed in FIG. 1 determines an equal contribution of currents
provided by electrodes E 2, 7 and 8 individually selected.
[0136] In this embodiment, the calculation module 16 of the system
10 disclosed in FIG. 1 determines an equal contribution of currents
provided by three anodes individually selected.
[0137] In this embodiment, each selected anode comprises 33.33%
current sourcing.
[0138] In this embodiment, the calculation module 16 translates
electrodes E of an electrode array A individually selected into an
equal weighting on a real electrode array A' comprising electrodes
E, for stimulating a patient.
[0139] Not shown in FIG. 2 is that the electrode array A' of the
related neuromodulation system could provide neuromodulation, in
particular neurostimulation to a patient based on the determined
current sourcing.
[0140] FIG. 3 shows an example of weighted contribution of currents
provided by electrodes E of a determined stimulation zone Z of an
electrode array A, determined by the calculation module 16 of the
system 10 disclosed in FIG. 1.
[0141] In this embodiment, the graphical information provided by
the graphical presentation module 12 of the system 10 disclosed in
FIG. 1 comprises an electrode array A.
[0142] In this embodiment, the electrode array A comprises 16
electrodes E.
[0143] In this embodiment, the electrode array A comprising 16
electrodes E provided by the graphical presentation module 12
reflects an electrode array A' of a neuromodulation system
configured and arranged for providing neuromodulation to a
patient.
[0144] In this embodiment, the selection module 14 comprises a user
interface.
[0145] In this embodiment, the selection module 14 comprises a
graphical user interface.
[0146] In this embodiment, the selection module 14 is configured
and arranged for determining at least one stimulation zone Z.
[0147] In this embodiment, the selection module 14 is configured
and arranged for determining at least one stimulation zone Z based
on a user input.
[0148] The shown embodiment is a display of a tablet computer, in
particular a touch screen.
[0149] However, in general, any display and/or touch screen and/or
programmer and/or mobile device could be possible.
[0150] In this embodiment, the display discloses the graphical
information provided by the graphical presentation module 12.
[0151] In this embodiment, the user determines a stimulation zone Z
by touching with a finger on the touch screen.
[0152] Alternatively, the stimulation zone could be determined via
a mouse click.
[0153] In general, it could be possible that the stimulation zone
and/or stimulation direction D is determined by a mouse and/or a
trackball and/or a joystick, a display and/or a touch screen and/or
a touch pad and/or an acoustic signal and/or acoustic tone and/or a
verbal command input.
[0154] In general, the selection module 14 could allow a user to
actuate at least one control element, including but not limited to
axes, points, knots, buttons, arrows, hand signals, emojis, crosses
and/or windows and/or text and/or shortcuts.
[0155] This user input could generally be translated by the
calculation module 16 into a certain weighting that could then be
sent to a neuromodulation system for providing neuromodulation.
[0156] In this embodiment, the system 10 is connected to a system
for neuromodulation, comprising an electrode array A'.
[0157] In this embodiment, the user input is translated by the
calculation module 16 into a certain weighting that could then be
sent to the neuromodulation system for providing
neuromodulation.
[0158] In this embodiment, the neuromodulation provided by the
system for providing neuromodulation can be modified according to a
modification of the user input.
[0159] In this embodiment, the calculation module 16 of the system
10 disclosed in FIG. 1 determines
[0160] a weighted contribution of currents provided by the
electrodes E of the stimulation zone Z.
[0161] In this embodiment, the calculation module 16 of the system
10 disclosed in FIG. 1 determines
[0162] a weighted contribution of currents provided by the
electrodes E of the stimulation zone Z, with two anodes comprising
40% of current sourcing and one anode comprising 20% of current
sourcing.
[0163] Not shown in this embodiment is that the weighted
contribution of currents provided by the electrodes E of the
stimulation zone Z is determined by calculating the Euclidean
distance from the electrodes E to the center C of the stimulation
zone Z.
[0164] Not shown in this embodiment is that the weighted
contribution of currents provided by the electrodes E of the
stimulation zone Z is determined by calculating the Euclidean
distance from the electrodes E to any other point on the electrode
array A, including the stimulation zone Z.
[0165] In this embodiment, the calculation module 16 translates the
selected stimulation zone Z of an electrode array A into a
different weighting on a real electrode array A' comprising
electrodes E, for stimulating a patient.
[0166] Not shown in FIG. 3 is that the electrode array A' of the
related neuromodulation system could provide neuromodulation, in
particular neurostimulation to a patient based on the determined
current sourcing.
[0167] FIG. 4 shows an example of an embodiment of an electrode
array A, comprising virtual electrodes V, according to the present
invention.
[0168] In this embodiment, the system 10 is connected to a system
for neuromodulation, comprising an electrode array A' (actual
physical electrode array A' comprising actual physical electrodes
E).
[0169] The shown example shows an actual physical electrode array
A' (left) as well as a display of a tablet computer, in particular
a touch screen (right).
[0170] In this embodiment, the display discloses the graphical
information provided by the graphical presentation module 12.
[0171] However, in general, any display and/or touch screen and/or
programmer and/or mobile device could be possible.
[0172] In this embodiment, the graphical information provided by
the graphical presentation module 12 of the system 10 disclosed in
FIG. 1 comprises an electrode array A.
[0173] In this embodiment, the graphical information provided by
the graphical presentation module 12 of the system 10 disclosed in
FIG. 1 comprises an electrode array A, comprising multiple
electrodes E, V.
[0174] In this embodiment, the electrode array A disclosed by the
graphical presentation module 12 comprises 16 physical electrodes
E.
[0175] In this embodiment, the electrode array A' of the actual
physical electrode array A comprises 16 physical electrodes E.
[0176] In an alternative embodiment, the electrode array A could
comprise any other number of physical electrodes E.
[0177] In this embodiment, the 16 physical electrodes E of the
electrode array A relate to the 16 physical electrodes of the
actual physical electrode array A' comprised in the neuromodulation
system related to the system 10 disclosed in FIG. 1.
[0178] In this embodiment, the electrode array A comprises 10
virtual electrodes V.
[0179] In this embodiment, the 10 virtual electrodes V do not
relate to physical electrodes of an actual physical electrode array
A' comprised in a neuromodulation system related to the system 10
disclosed in FIG. 1.
[0180] In other words, the 10 virtual electrodes V allow to go from
16 electrodes E present on an electrode array A to 26 electrodes E,
V.
[0181] Not shown in FIG. 4 is that any number of virtual electrodes
V could be added to the electrodes E.
[0182] In this embodiment, the selection module 14 comprises a user
interface.
[0183] In this embodiment, the selection module 14 comprises a
graphical user interface.
[0184] In this embodiment, the selection module 14 is configured
and arranged for selecting electrodes E, V.
[0185] In this embodiment, the selection module 14 is configured
and arranged for selecting electrodes E, V based on a user
input.
[0186] In this embodiment, the user determines a stimulation zone Z
on the electrode array A' by selecting actual physical electrodes E
and virtual electrodes V on the electrode array A shown on the
display.
[0187] In this embodiment, the stimulation zone Z is determined by
selecting electrodes E, V via a mouse click.
[0188] In general, it could be possible that the stimulation zone
and/or a stimulation direction D is determined by a mouse and/or a
trackball and/or a joystick, a display and/or a touch screen and/or
a touch pad and/or an acoustic signal and/or acoustic tone and/or a
verbal command input.
[0189] In general, the selection module 14 could allow a user to
actuate at least one control element, including but not limited to
axes, points, knots, buttons, arrows, hand signals, emojis, crosses
and/or windows and/or text and/or shortcuts.
[0190] This user input could generally be translated by the
calculation module 16 into a certain weighting that could then be
sent to a neuromodulation system for providing neuromodulation.
[0191] This user input, thus the selection of physical electrodes E
and virtual electrodes V on an electrode array A could generally be
translated by the calculation module 16 into a certain weighting
(equal or unequal) that could then be sent to a neuromodulation
system for providing neuromodulation via an electrode array A'
comprising physical electrodes E.
[0192] Not shown in FIG. 4 is that the virtual electrodes V that
can be selected for stimulation could be more understandable and
graspable to the user than current-weighting or current-steering in
percentages.
[0193] Not shown in FIG. 4 is that while selecting and/or
interacting with virtual electrodes V, at least one key performance
indicator, such as the selectivity index could be provided, in
particular as graphical information provided by the graphical
presentation module 12.
[0194] Not shown in FIG. 4 is that while selecting and/or
interacting with virtual electrodes V, at least one key performance
indicator, such as the selectivity index could be provided
dynamically, in particular as graphical information provided by the
graphical presentation module 12.
[0195] FIG. 5 shows an example of determining a stimulation
direction D, according to the present invention.
[0196] The shown embodiment is a display of a tablet computer, in
particular a touch screen.
[0197] However, in general, any display and/or touch screen and/or
programmer and/or mobile device could be possible.
[0198] In this embodiment, the display discloses the graphical
information provided by the graphical presentation module 12.
[0199] In this embodiment, the graphical information provided by
the graphical presentation module 12 of the system 10 disclosed in
FIG. 1 comprises an electrode array A.
[0200] In this embodiment, the selection module 14 comprises a user
interface.
[0201] In this embodiment, the selection module 14 comprises a
graphical user interface.
[0202] In this embodiment, the selection module 14 is configured
and arranged for determining a stimulation direction D.
[0203] In this embodiment, the selection module 14 is configured
and arranged for determining at least one stimulation direction D
based on a user input.
[0204] In this embodiment, the user determines a stimulation
direction D by touching with a finger on the touch screen and
moving the finger.
[0205] In this embodiment, the stimulation direction D is a
vector.
[0206] Alternatively, the stimulation direction D could be
determined via a mouse click.
[0207] In general, it could be possible that the stimulation
direction D is determined by a mouse and/or a trackball and/or a
joystick, a display and/or a touch screen and/or a touch pad and/or
an acoustic signal and/or acoustic tone and/or a verbal command
input.
[0208] In general, the selection module 14 could allow a user to
actuate at least one control element, including but not limited to
axes, points, knots, buttons, arrows, hand signals, emojis, crosses
and/or windows and/or text and/or shortcuts.
[0209] This user input could generally be translated by the
calculation module 16 into a certain weighting that could then be
sent to a neuromodulation system for providing neuromodulation.
[0210] Not shown in FIG. 5 is that the stimulation direction D on
the electrode array A comprises electrodes E.
[0211] Not shown in FIG. 5 is that the calculation module 16 of the
system 10 disclosed in FIG. 1 determines a weighted contribution of
currents provided by the electrodes E of the stimulation direction
D.
[0212] In general, the user input could generally be translated by
the calculation module 16 into a certain weighting that could then
be sent to a neuromodulation system for providing
neuromodulation.
[0213] Not shown in FIG. 5 is that the calculation module 16 of the
system 10 disclosed in FIG. 1 could generally determine a weighted
contribution of currents provided by the electrodes E of the
stimulation direction D or an equal contribution of currents
provided by the electrodes E of the stimulation direction D.
[0214] FIG. 6 shows two examples of graphical information provided
by the graphical presentation module, combining an electrode array
A with a target area X, according to the present invention.
[0215] The shown embodiment (both examples) is a display of a
tablet computer, in particular a touch screen.
[0216] However, in general, any touch screen and/or programmer
and/or mobile device could be possible.
[0217] In this embodiment, the display discloses the graphical
information provided by the graphical presentation module 12 of the
system 10 disclosed in FIG. 1.
[0218] In this embodiment, the selection module 14 comprises a user
interface.
[0219] In this embodiment, the selection module 14 comprises a
graphical user interface.
[0220] In this embodiment, the electrode array A is comprised in a
lead L.
[0221] In this embodiment, the lead L is superimposed on a target
area X.
[0222] In this embodiment, the graphical information provided by
the graphical presentation module 12 of the system 10 disclosed in
FIG. 1 comprises an electrode array A and a target area X.
[0223] Left: In this embodiment, the target area X is provided as
patient specific data obtained my MRI.
[0224] However, it could be generally possible, that the target
area X is provided as patient specific data obtained by other
methods, such as X-Ray, CT, or pictures obtained during
surgery.
[0225] Right: In this embodiment, the target area X is a
reconstruction.
[0226] In this embodiment, the target area X is a model M.
[0227] In general, the target area X could be provided as a 2D
model M and/or a 3D model M.
[0228] Not shown in FIG. 6 is that the user could place the
electrode array A on at least one target area X by touching with
his finger on the electrode array A and moving the electrode array
A with his finger.
[0229] Not shown in FIG. 6 is that a computer-assisted module could
at least partially automatically determining a stimulation zone Z
and/or a stimulation direction D on the electrode array A
comprising at least one electrode E, V and/or for at least
partially automatically selecting at least one electrode E, V
optionally based on the medical imaging superimposing and/or a
model M.
[0230] It could be generally possible that the electrode array A is
superimposed on a medical image and/or model.
[0231] FIG. 7 shows a further example of graphical information
provided by the graphical presentation module, combining an
electrode array A with at least one possible target area X,
according to the present invention.
[0232] The shown embodiment (both examples) is a display of a
tablet computer, in particular a touch screen.
[0233] However, in general, any touch screen and/or programmer
and/or mobile device could be possible.
[0234] In this embodiment, the display discloses the graphical
information provided by the graphical presentation module 12 of the
system 10 disclosed in FIG. 1.
[0235] In this embodiment, the selection module 14 comprises a user
interface.
[0236] In this embodiment, the selection module 14 comprises a
graphical user interface.
[0237] In this embodiment, the graphical information provided by
the graphical presentation module 12 of the system 10 disclosed in
FIG. 1 comprises an electrode array A and different possible target
areas X.
[0238] In this embodiment, the electrode array A is comprised in a
lead L.
[0239] In this embodiment, different possible target areas X with a
superimposed lead L are shown.
[0240] In this embodiment, the different possible target areas X
are shown as buttons B.
[0241] In this embodiment, a user can select at least one target
area X by selecting at least one corresponding button B, e.g. by
touching the corresponding button B with a finger.
[0242] Alternative ways of selection are disclosed for FIG. 1, 2,
3, 4, 5, 6.
[0243] In this embodiment, the different possible target areas X
are provided schematically as spinal cord and pairs of spinal
nerves, i.e. pairs of thoracic nerves T11, T12 and lumbar nerves
L1, L2.
[0244] In an alternative embodiment, the different possible target
areas X could alternatively and/or additionally include muscles
(e.g. leg/trunk muscles) and/or organs.
[0245] In general, muscles and/or organs could be positioned under
an electrode array A and/or a lead L and/or or next to an electrode
array A and/or a lead L.
[0246] However, in an alternative embodiment, the different
possible target areas X could be provided as any spinal nerve
and/or any combination of at least two spinal nerves.
[0247] In general, the at least one target area X could be or could
comprise fictious and/or realistic anatomical conditions of a
mammal, in particular a human being, such as the patient
himself.
[0248] In general, the at least one target area X could be or could
comprise at least one target nerve and/or nerve fiber and/or dorsal
root and/or area of the spinal cord and/or tissue and/or area
related to the spinal cord and/or muscle fiber and/or muscle.
[0249] In general, image data and/or 2D models M and/or 3D models M
could be used as target area X for visual representation of anatomy
of the patient, e.g. the dorsal roots.
[0250] In this embodiment, the user can select at least one target
area X, i.e. left and/or right thoracic nerve T11 and/or T12 and/or
left and/or right lumbar nerve L1 and/or L2.
[0251] In this embodiment, the user can select at least one target
area X, i.e. left and/or right thoracic nerve T11 and/or T12 and/or
left and/or right lumbar nerve L1 and/or L2 by selecting the
respective button B.
[0252] In general, via a user interface comprised in the selection
module 14, a target area X could be determined and weighted by the
system 10.
[0253] Not shown in this embodiment is, that the calculation module
16 could translate the at least one target area X selected into a
certain weighting, such as a current weighing, on a real electrode
array A' comprising electrodes E related to the system 10 for
stimulating a patient.
[0254] In general, the target area X could be alternatively and/or
additionally provided as kinematic model M, wherein intended
muscles could be determined and weighted and/or unwanted crosstalk
between agonists and antagonists could be assigned.
[0255] Not shown in FIG. 7 is that while selecting and/or
interacting with target areas, at least one key performance
indicator, such as the selectivity index could be provided, in
particular as graphical information provided by the graphical
presentation module 12.
[0256] In general, it could also be possible that target muscles
and/or planed movements are selected, and stimulation is applied
according to the selection, cf. FIG. 8.
[0257] FIG. 8 shows a further example of graphical information
provided by the graphical presentation module 12, according to the
present invention.
[0258] The shown embodiment is a display of a tablet computer, in
particular a touch screen.
[0259] However, in general, any touch screen and/or screen and/or
mobile device could be possible.
[0260] In this embodiment, the display discloses the graphical
information provided by the graphical presentation module 12 of the
system 10 disclosed in FIG. 1.
[0261] In this embodiment, the selection module 14 comprises a user
interface.
[0262] In this embodiment, the selection module 14 comprises a
graphical user interface.
[0263] In this embodiment, the graphical information provided by
the graphical presentation module 12 of the system 10 disclosed in
FIG. 1 comprises possible target muscles MU to be stimulated,
illustrated as different muscles MU of an avatar AV.
[0264] In this embodiment, the graphical information provided by
the graphical presentation module 12 of the system 10 disclosed in
FIG. 1 further comprises a schema configured and arranged to
illustrate a target area X based on target muscles MU.
[0265] In this embodiment, a user can select at least one target
muscle MU by selecting at least one muscle MU, e.g. by touching the
corresponding muscle MU of the avatar AV with a finger.
[0266] In this embodiment, the user selects the right quadriceps
Q.
[0267] In this embodiment, the selection module 14, based on the
selected target muscle MU, selects a target area X.
[0268] In this embodiment, the target area X comprises spinal
nerves L1-L5.
[0269] Not shown in this embodiment is that a patient is implanted
with an electrode array A (electrode array A also shown in FIG. 8)
capable of providing stimulation on the target area X.
[0270] In this embodiment, the calculation module 16 determines a
contribution of currents provided to the target area X selected in
order to stimulate the muscle MU selected.
[0271] In this embodiment, the contribution of currents provided to
the target area X gradually decreases from the center to the
outside O of the target area X.
[0272] The electrode array A provides stimulation to the target
area X via selected electrodes E and selected stimulation
parameters.
[0273] In this example, the current is 1.5 mA, the frequency is
1.0000 Hz and the pulse-width is 0.3 ms.
[0274] However, in an alternative embodiment, other stimulation
parameters could be generally possible.
[0275] It will be appreciated that the configurations and routines
disclosed herein are exemplary in nature, and that these specific
embodiments are not to be considered in a limiting sense, because
numerous variations are possible. The subject matter of the present
disclosure includes all novel and non-obvious combinations and
sub-combinations of the various systems and configurations, and
other features, functions, and/or properties disclosed herein.
[0276] The following claims particularly point out certain
combinations and sub-combinations regarded as novel and
non-obvious. Such claims should be understood to include
incorporation of one or more such elements, neither requiring nor
excluding two or more such elements. Other combinations and
sub-combinations of the disclosed features, functions, elements,
and/or properties may be claimed through amendment of the present
claims or through presentation of new claims in this or a related
application. Such claims, whether broader, narrower, equal, or
different in scope to the original claims, are also regarded as
included within the subject matter of the present disclosure.
* * * * *