U.S. patent application number 17/740950 was filed with the patent office on 2022-08-25 for neurostimulation device with recording patch.
This patent application is currently assigned to ALEVA NEUROTHERAPEUTICS. The applicant listed for this patent is ALEVA NEUROTHERAPEUTICS. Invention is credited to Alain Dransart, Andre Mercanzini, Khoa Nguyen.
Application Number | 20220266024 17/740950 |
Document ID | / |
Family ID | |
Filed Date | 2022-08-25 |
United States Patent
Application |
20220266024 |
Kind Code |
A1 |
Mercanzini; Andre ; et
al. |
August 25, 2022 |
NEUROSTIMULATION DEVICE WITH RECORDING PATCH
Abstract
The present disclosure describes systems and methods for
recording electrical activity, such as local field potentials. The
system can include a recording patch that is placed inline between
an implanted neurological lead and an implantable pulse stimulator.
The recording patch can include recording and amplification
circuitry that detects, records, and amplifies electrical activity
(also referred to as signals) from a target site. The system can be
used to select over which of the lead's electrodes therapeutic
stimulations are delivered.
Inventors: |
Mercanzini; Andre; (Saint
Sulpice, CH) ; Dransart; Alain; (Lausanne, CH)
; Nguyen; Khoa; (Lausanne, CH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ALEVA NEUROTHERAPEUTICS |
Lausanne |
|
CH |
|
|
Assignee: |
ALEVA NEUROTHERAPEUTICS
Lausanne
CH
|
Appl. No.: |
17/740950 |
Filed: |
May 10, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16424044 |
May 28, 2019 |
11344728 |
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17740950 |
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International
Class: |
A61N 1/36 20060101
A61N001/36; A61N 1/05 20060101 A61N001/05; A61N 1/08 20060101
A61N001/08; A61N 1/372 20060101 A61N001/372 |
Claims
1-20. (canceled)
21. An implantable device, comprising: a housing to secure against
a subject; a circuit disposed in the housing, the circuit to:
receive, at least partially concurrent with presentation of a
prompt to the subject to perform an activity, a first biological
signal from the subject passed via a switch connected with a lead;
set, responsive to completion of the prompt, the switch to connect
with a stimulator to pass a stimulation signal from the stimulator
to the lead; receive, subsequent to passing of the stimulation
signal from the simulator, a second biological signal from the
subject passed via the switch with the lead; and determine a
characteristic based on the first biological signal and the second
biological signal.
22. The device of claim 21, comprising the circuit to: receive,
prior to the presentation of the prompt for the subject to perform
the activity, a third biological signal; and determine the
characteristic corresponding to a difference between the second
biological signal and the third biological signal.
23. The device of claim 21, comprising the circuit to: receive, at
least partially concurrent with presentation of a second prompt to
the subject to perform a second activity in accordance with a
policy, a third biological signal; and determine a characteristic
based on the first biological signal for the activity and the third
biological signal for the second activity.
24. The device of claim 21, comprising the circuit to: select, from
a plurality of electrodes of the lead, an electrode to deliver the
stimulation signal from the stimulator to the lead based on the
characteristic of the first biological signal; and receive the
second biological signal from the subject via the electrode of the
plurality of electrodes of the lead.
25. The device of claim 21, comprising the circuit to: record the
first biological signal over a first time window relative to the
presentation of the prompt to perform the activity; and record the
second biological signal over a second time window relative to the
passage of the stimulation signal.
26. The device of claim 21, comprising the circuit to determine the
characteristic including a first power level in a beta-band of the
first biological signal and a second power level in a beta-band of
the second biological signal.
27. The device of claim 21, comprising the circuit to communicate
with a programmer via an antenna to transmit at least one of the
first biological signal or the second biological signal.
28. A programmer device, comprising: one or more processors coupled
with memory in communication with a recording patch, configured to:
transmit a first instruction to set the recording patch to receive,
at least partially concurrent with presentation of a prompt to the
subject to perform an activity, a first biological signal from the
subject passed via a switch connected a lead; transmit a second
instruction to set the recording patch to set, responsive to
completion of the prompt, the switch to connect with a stimulator
to pass a stimulation signal from the stimulator to the lead;
transmit a third instruction to set the recording patch to receive
a second biological signal from the subject passed via the switch
connected with the lead; and determine a characteristic based on
the first biological signal and the second biological signal from
the recording patch.
29. The device of claim 28, comprising the one or more processors
to: select, responsive to a determination to test the subject to
perform another activity, a second activity from a plurality of
activities in accordance with a policy; and transmit a fourth
instruction to set the recording patch to receive, at least
partially concurrent with presentation of a second prompt to
perform the second activity, a third biological signal from the
subject passed via the switch.
30. The device of claim 28, comprising the one or more processors
to: determine, subsequent to the completion of the prompt, to not
test the subject to perform another activity in accordance with a
policy; and transmit, responsive to the determination to not test
the subject to perform another activity, the second instruction to
set the switch to connect with the stimulator.
31. The device of claim 28, comprising the one or more processors
to: select, from a plurality of electrodes of the lead, an
electrode to deliver the stimulation signal from the stimulator to
the lead based on the characteristic of the first biological
signal; and transmit the third instruction to the recording patch
to receive the second biological signal from the subject via the
electrode of the plurality of electrodes of the lead.
32. The device of claim 28, comprising the one or more processors
to: record the first biological signal over a first time window
relative to the presentation of the prompt to perform the activity;
and record the second biological signal over a second time window
relative to the passage of the stimulation signal.
33. The device of claim 28, comprising the one or more processors
to determine the characteristic including a first power level in a
beta-band of the first biological signal and a second power level
in a beta-band of the second biological signal.
34. A method, comprising: receiving, by a recording patch secured
against a skull of a subject, a first biological signal from the
subject passed via a switch connected with a lead, concurrent with
presentation of a prompt to the subject; setting, by the recording
patch, responsive to completion of the prompt, the switch to
connect with a stimulator to pass a stimulation signal from the
stimulator to the lead; receiving, by the recording patch,
subsequent to passing of the stimulation signal from the simulator,
a second biological signal from the subject passed via the switch
connected with the lead; and determining, by the recording patch, a
characteristic of the first biological signal and the second
biological signal.
35. The method of claim 34, comprising: receiving, by the recording
patch, prior to the presentation of the prompt for the subject to
perform the activity, a third biological signal; and determining,
by the recording patch, the characteristic corresponding to a
difference between the second biological signal and the third
biological signal.
36. The method of claim 34, comprising: receiving, by the recording
patch, at least partially concurrent with presentation of a second
prompt to the subject to perform a second activity in accordance
with a policy, a third biological signal; and determining, by the
recording patch, a characteristic based on the first biological
signal for the activity and the third biological signal for the
second activity.
37. The method of claim 34, comprising: selecting, by the recording
patch, from a plurality of electrodes of the lead, an electrode to
deliver the stimulation signal from the stimulator to the lead
based on the characteristic of the first biological signal; and
receiving, by the recording patch, the second biological signal
from the subject via the electrode of the plurality of electrodes
of the lead.
38. The method of claim 34, comprising: recording, by the recording
patch, the first biological signal over a first time window
relative to the presentation of the prompt to perform the activity;
and recording, by the recording patch, the second biological signal
over a second time window relative to the passage of the
stimulation signal.
39. The method of claim 34, comprising: determining, by the
recording patch, the characteristic including a first power level
in a beta-band of the first biological signal and a second power
level in a beta-band of the second biological signal.
40. The method of claim 34, comprising: communicating, by the
recording patch, with a programmer via an antenna to transmit at
least one of the first biological signal or the second biological
signal.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims benefit of priority under 35
U.S.C. .sctn. 120 as a continuation of U.S. patent application Ser.
No. 16/424,044, titled "NEUROSTIMULATION DEVICE WITH RECORDING
PATCH," filed May 28, 2019, which is incorporated herein by
reference in its entirety.
BACKGROUND OF THE DISCLOSURE
[0002] Deep brain stimulation (DBS) is a neurostimulation therapy
that can involve electrical stimulation systems that stimulate the
human brain and body. DBS can be used to treat a number of
neurological disorders. Typically, DBS involves electrically
stimulating a target area of the brain.
SUMMARY OF THE DISCLOSURE
[0003] The present disclosure describes systems and methods for
recording electrical activity, such as local field potentials. The
system can include a recording patch that is placed inline between
an implanted neurological lead and an implantable pulse stimulator.
The recording patch can include recording and amplification
circuitry that detects, records, and amplifies electrical activity
(also referred to as signals) from a target site. The system can be
used to select over which of the lead's electrodes to deliver
therapeutic stimulations. The system can select the electrodes
based on the amount of power within the beta band of the signal or
other characteristics of the signal.
[0004] According to at least one aspect of the disclosure, an
implantable device can include a first port. The first port can be
configured to receive a connection from an implantable pulse
stimulator. The first port can include a first plurality of
connections. The device can include a second port. The second port
can be configured to receive a connection from an implantable lead.
The second port can include a second plurality of connections. The
device can include a plurality of switches. The switches can be
configured to selectively interconnect, at a first time point, the
first plurality of connections with the second plurality of
connections to pass a stimulation signal from the implantable pulse
stimulator to the implantable lead. The switches can selectively
interconnect, at a second time point, the second plurality of
connections with a recording module. The recording module can
generate an amplified biological signal based on a biological
signal received from the second plurality of connections. The
recording module can transmit the amplified biological signal to a
receiver.
[0005] According to at least one aspect of the disclosure, a method
can include implanting a recording patch into a subject. The
recording patch can include a first port that can be configured to
receive a connection from an implantable pulse stimulator. The
first port can include a first plurality of connections. The
recording patch can include a second port that can be configured to
receive a connection from an implantable lead that can include a
plurality of electrodes. The second port can include a second
plurality of connections. The recording patch can include a
plurality of switches in electrical communication with the first
plurality of connections and the second plurality of connections.
The recording patch can include a recording module. The method can
include coupling, with the plurality of switches, the second
plurality of connections with the recording module. The method can
include receiving, at the second plurality of connections,
biological signals from the implantable lead. The method can
include generating, by the recording module, amplified biological
signals based on the biological signals. The method can include
determining at least one signal characteristic of the biological
signals. The method can include selecting an electrode of the
plurality of electrodes based on the at least one signal
characteristic of the biological signal.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] The accompanying drawings are not intended to be drawn to
scale. Like reference numbers and designations in the various
drawings indicate like elements. For purposes of clarity, not every
component may be labelled in every drawing. In the drawings:
[0007] FIG. 1 illustrates a front view of a subject implanted with
an example system for performing neurostimulation.
[0008] FIG. 2 illustrates a perspective view of the subject
implanted with the example system for performing
neurostimulation.
[0009] FIG. 3 illustrates an enlarged view of the recording patch
implanted below the subject's scalp.
[0010] FIGS. 4-6 illustrate enlarged views of the recording patch
illustrated in FIGS. 1-3.
[0011] FIGS. 7A and 7B illustrate an example recording patch.
[0012] FIG. 8 illustrates a block diagram of an example schematic
of the system illustrated in FIGS. 1-3.
[0013] FIGS. 9A and 9B illustrate block diagrams example methods to
record biological signals with the system described herein.
[0014] FIGS. 10-13 illustrate plots of the power spectral densities
of signals recorded with the systems described herein.
[0015] FIG. 14 illustrates an example heat map of the amount of
beta activity recorded at each of the electrodes of the lead during
a plurality of activities.
DETAILED DESCRIPTION
[0016] The various concepts introduced above and discussed in
greater detail below may be implemented in any of numerous ways, as
the described concepts are not limited to any particular manner of
implementation. Examples of specific implementations and
applications are provided primarily for illustrative purposes.
[0017] The present disclosure describes a technical solution for
performing neural recordings and stimulations. The system can
include a recording patch that can be coupled inline between an
implanted pulse stimulator and a lead implanted into, for example,
a subject's brain. The recording patch can receive biological
signals from the subject's brain and can amplify the biological
signals. The biological signals can be any electrophysiological
signal generated by the patient, such as local field potentials,
single units, neural ensembles, or other electrical signals
generated by patient's brain or body. The recording patch transmit
the amplified signals to an external device. The external device
can also provide wireless power to the recording patch. The signals
collected by the recording patch can be used to guide the subject's
therapy. For example, the recording patch or external device
associated with the recording patch can select stimulation
electrodes based on power distributions within specific frequency
bands of the amplified signals. When not in use, the recording
patch can be placed into a pass-through mode that enables the
stimulation signals from the pulse stimulator to pass substantially
unchanged through the recording patch to the lead.
[0018] FIG. 1 illustrates a front view of a subject implanted with
an example system 50 for performing neurostimulation. FIG. 2
illustrates a perspective view of the subject implanted with the
example system 50 for performing neurostimulation. FIG. 3
illustrates an enlarged view of the recording patch 100 implanted
below the subject's scalp 300.
[0019] The system 50 includes a recording patch 100 implanted below
the subject's scalp. The recording patch 100 is coupled with an
implantable pulse stimulator 102, which is implanted into the
subject 104. The recording patch 100 is also coupled with an
implantable lead 106. An implantable lead 106 can be implanted into
each hemisphere of the subject's brain (or other location within
the subject). The recording patch 100 can be coupled with the pulse
generator 102 and the leads 106 via cables 108.
[0020] The system 50 can include one or more recording patches 100.
The recording patches 100 are described further in relation to
FIGS. 3-9, among others. The recording patch 100 can improve (or
provide) the recording capabilities for the implantable pulse
stimulator 102. The pulse stimulator 102 can be a stimulation only
device (e.g., the pulse stimulator 102 may not include recording
capabilities) and the recording patch 100 can perform electrical
recordings that are used to monitor the subject's response to
electrical stimulations and coordinate the subject's therapy.
[0021] The recording patch 100 can be placed inline between the
implantable pulse stimulator 102 and the leads 106. The implantable
pulse stimulator 102 can be configured to deliver electrical
stimulation to the subject via the leads 106.
[0022] The recording patch 100 can amplify electrical signals
(e.g., biological signals) detected by the electrodes of the leads
106. The recording patch 100 can amplify the signals and transmit
the amplified signals externally from the subject to, for example,
an external programmer, which can also be referred to as a
receiver. The recording patch 100 can calculate or determine one or
more characteristics of the signals and transmit the
characteristics of the signal externally from the subject. In some
cases, the recording patch 100 can transmit the amplified signals
to an external programmer that can calculate the signal
characteristics. The signal characteristics can include power
distributions within specific frequency ranges of the amplified
signals.
[0023] The leads 106 can record or detect local field potentials
(LFPs). LFPs can be low frequency fluctuations of electrical
activity below about 500 Hz. LFPs can represent the
spatial-temporal summation of postsynaptic potentials from local
neuronal ensembles in the vicinity of the electrode. The LFPs can
be viewed as a metric of neuronal synchronization. In Parkinson's
subjects, a suppression of beta activity by high-frequency
stimulation of the subthalamic nucleus can lead to motor
improvements.
[0024] The recording patch 100 can select one or more of the lead's
electrodes as stimulating electrodes. The selection of the
stimulating electrodes can be based on the signals (or the
characteristics thereof) detected or recorded at the recording
patch 100. For example, the recording patch 100 can select the
electrodes for stimulation that include the most power within the
beta band.
[0025] When the recording patch 100 is not being used to actively
record signals from the subject 104, the recording patch 100 can be
placed into a stimulation mode (which can also be referred to as a
pass-through mode) and can transmit or forward stimulation signals
from the implantable pulse stimulator 102 to the leads 106. In the
pass-through mode, the recording patch 100 does not substantially
affect the stimulation signal generated by the implantable pulse
stimulator 102 as the stimulation signal passes through the
recording patch 100. For example, the voltage and current of the
stimulation signal can be substantially the same when entering and
exiting the recording patch 100.
[0026] The implantable pulse stimulator 102 can generate
therapeutic, electrical stimulations that can be delivered to the
subject's brain or other locations by leads 106. The implantable
pulse stimulator 102 can be implanted into the subject 104 at a
surgical site remote to the recording patch 100 and the leads 106.
For example, the implantable pulse stimulator 102 can be implanted
into a surgically created pocket in the subject's chest, between
the skin and muscle. The implantable pulse stimulator 102 can
generate stimulation signals that pass to the subject 104 via the
cables 108, recording patch 100, and lead 106. The stimulation
signal can include a plurality of wave forms including, but not
limited to, pulses, charged balanced pulses, sinusoidal waves,
square waves, triangle waves, and combinations thereof. The
electrical stimulation can provide a therapeutic benefit to the
subject, such as, suppressing beta activity.
[0027] The implantable pulse stimulator 102 can be a stimulating
only device. For example, the implantable pulse stimulator 102 does
not receive biological signals from the subject. The implantable
pulse stimulator 102 can be a stimulating and recording device. For
example, the implantable pulse stimulator 102 can both generate and
output stimulation signals and also receive biological signals that
the implantable pulse stimulator 102 digitizes and stores.
[0028] The system 50 can include a plurality of cables 108. One or
more cables 108 can interconnect the recording patch 100 and the
implantable pulse stimulator 102 and the recording patch 100 and
the leads 106. Each cable 108 can include a plurality of conductors
to independently carry a plurality of signals between the
components connected with the cable 108. For example, the lead 106
can have 12 electrodes and the cable 108 can include a dedicated
conductor for each of the different electrodes. For each conductor
within the cable 108, the cable 108 can include a terminal or
connector at each end of the cable 108.
[0029] The system 50 can include one or more leads 106. The system
50 can include a lead 106 for each recording patch 100. The lead
106 can be a multielectrode lead. The lead 106 can include a distal
end and a proximal end. The distal end can include a plurality of
electrodes. The proximal end can include a plurality of terminal
contacts. Each of the terminal contacts can be electrically coupled
with at least one of the electrodes. For example, a wire (or other
electrical trace) can run through the interior of the lead 106 from
one of the terminal contacts to a contact disposed toward the
distal end that is in electrical communication with the electrode.
The lead 106 can be a MEMS-based lead 106. For example, the lead
106 can include a MEMS film that includes a plurality of
electrodes. The MEMS film can be manufactured as a planar film. The
MEMS film can be heated and molded to form a cylinder. The cylinder
can be backfilled with a polymer to electrically encapsulate the
connections of the lead 106 and fill the cylinder's lumen. The lead
106 can be a lead as described in U.S. Pat. No. 9,474,894, which is
herein incorporated by reference in its entirety.
[0030] FIGS. 4-6 illustrate enlarged views of the recording patch
100. The recording patch 100 can include a plurality of ports 400.
The ports 400 can include a plurality of connections 402. The ports
400 can include screws 412 to secure the cables 108 into the ports
400. The recording patch 100 can include an antenna 404 for
receiving power from an external source and to transmit and receive
data with an external source. The recording patch 100 can include a
controller 406 to control data exchange and a plurality of switches
that interconnect the ports 400 with a recording module. The
housing 408 of the recording patch 100 can include a pass-through
port 414 through which the lead 106 passes. The housing 408 can
include a screw 410 that can be used to secure the recording patch
100 to the subject's skull.
[0031] The recording patch 100 can include a plurality of ports
400. The recording patch 100 can include a first port 400 and a
second port 400. One of the ports 400 can be configured to receive
a connection from the pulse stimulator 102. One of the ports 400
can be configured to receive a connection from the lead 106.
[0032] The ports 400 can be male connections, female connections,
or a combination thereof. For example, one port 400 can be a female
connector and a second port 400 can be a male connector. The ports
400 can each include a plurality of connections 402. For example,
for a female port 400, the plurality of connections 402 can be
distributed along the axial length of the port's internal lumen.
For a male port 400, the connections 402 can be distributed along
the axial length of the port's barrel.
[0033] Each of the connections 402 can be ring-based electrical
contacts. At each axial position of the connections 402 along the
port 400, the connections 402 can include a metal layer around the
circumference of the port's lumen. The connections 402 can be
springed or hinged pins that can depress onto a contact of the
cable 108 when the cable 108 is inserted into the port 400. The
cable 108 can include a plurality of contacts along its tip. Each
of the cable's contacts can align with one of the connections 402
when the cable 108 is inserted into the port 400. Each port can
include between about 2 and about 64, between about 6 and about 64,
between about 12 and about 64, or between about 8 and about 32
connections 402. The connections 402 can include Platinum-Iridium,
MP35N, or other medical implantable conductive metal.
[0034] The port 400 can include a mechanism to secure the cable 108
to the recording patch 100. For example, each port 400 can include
a screw 412. The screw 412 can be a blunt tipped screw such that
the screw 412 does not puncture the cable 108. Once the cable 108
is inserted into the port 400, the screw 412 can be tightened onto
the cable 108 to secure the cable 108 in place. The mechanism to
secure the cable 108 into place can include a lure-lock or other
type of latching system.
[0035] The recording patch 100 can include an antenna 404. The
antenna 404 can be a wire coil that is embedded within the body of
the housing 408. The antenna 404 can be a plurality of electrical
traces etched onto a circuit board to which the other components
(e.g., the controller 406 and power supply) are coupled.
[0036] The diameter of the antenna 404 can be selected to enable
the antenna 404 to efficiently couple with an external source, such
as an external programmer, power source, or data storage device
(each of these functions can be performed by a single, external
device). The antenna 404 can enable the recording patch 100 to
wirelessly communicate with an external programmer over the 27 MHz
frequency. Other frequencies which could be used are any of those
determined by the International Telecommunication Union
Radiocommunication Sector (ITU-R) in their reserved Industrial,
Scientific, and Medical (ISM) Bands such as for example, but not
limited to, 6.780 Mhz, 13.560 MHz, 40.680 MHz, 2.450 GHz, 5.80 GHz.
The antenna diameter can be inversely proportional to the
wavelength of the signal the antenna 404 transmits over. For
example, with a 27 MHz frequency the loop diameter of the antenna
404 can be about 25 mm in diameter. In general, the loop diameter
of the antenna is about half the wavelength of the frequency used
to communicate with the antenna.
[0037] The antenna 404 can be used to inductively receive power
from an external power source. The recording patch 100 can have no
internal power source. In this case the inductively coupled power
from the external source can be used to power the recording patch
100. The external power source can provide sufficient power to
power the recording patch 100 during recording operations. For
example, the recording patch 100 can inductively receive between
about 5 mW and about 15 mW when in operation. The recording patch
100 can include an internal power source, such as a battery. The
recording patch 100 can recharge the battery by inductively
receiving power via the antenna 404, which is stored in the
battery.
[0038] The antenna 404 can be used to transmit data between the
recording patch 100 and an external source. For example, the
recording patch 100 can receive electrical signals from the lead
106. The electrical signals can be biological signals, such as
electrical signals generated by the subject's brain. The recording
patch 100 can amplify the received signals. The recording patch 100
can digitize the signals. The recording patch 100 can transmit the
digitized signals to the external source via the antenna 404. The
antenna 404 can also receive configuration information from the
external source. For example, via the antenna 404, the recording
patch 100 can receive configuration information that puts the
recording patch 100 into a pass-through mode or a recording mode.
The configuration information can include connection information.
The connection information can include instructions for the
interconnection of the first port's connections 402 with the second
port's connections 402.
[0039] The recording patch 100 can include a controller 406. The
controller 406 is also described further in relation to FIG. 8,
among others. The controller 406 can include one or more amplifies.
For example, the controller 406 can include an amplifier for each
of the channels coming into the recording patch 100 from the lead
106. The amplifiers can be configured to amplify the signals before
the signals are transmitted to an external source.
[0040] The controller 406 can include different modules. For
example, the controller 406 can include a recording module that
controls the recording and digitization of the signals coming into
the recording patch 100 from the lead 106. The controller 406 can
include a selector module. The selector module can determine which
of the lead's electrodes should be used to deliver electrical
stimulation to the subject. For example, based on a power
distribution within the beta band, the selector module can select
and configure which of the connections in the port 400 going to the
lead 106 should be coupled with connections in port 400 going to
the pulse stimulator 102.
[0041] The selector module can select the electrodes to use for
stimulation based on the signal characteristics of the signals
received from the lead 106. The characteristics can be the amount
of power in a beta band of the received signals. The beta band can
be between about 10 Hz and about 30 Hz, for example. The selector
module can select the electrodes that include the most power in the
beta band.
[0042] The components of the recording patch 100 can be enclosed
within a housing 408. For example, the controller 406 and the
antenna 404 can be contained within an internal space of the
housing 408. The housing 408 can be manufactured from plastic or be
a hermetically sealed titanium case. The housing 408 is molded
around the components of the recording patch 100. The housing 408
can include one or more electrode sites to enable the housing 408
to be used as a ground or reference for the recordings made at the
lead 106. The housing 408 can be metal and the housing 408 itself
can be used as a ground or reference electrode. The housing 408 can
be implemented in Titanium, Titanium Dioxide, Ceramic, Polymer, or
any material that conductive or capacitive, biocompatible, and
maintains the inner contents sealed.
[0043] The housing 408 can include a convex shape that enables the
recording patch 100 to be secure against the subject's skull. The
convex shape of the recording patch 100 can substantially match the
curvature of the subject's skull. The housing 408 can be flexible
to conform to the curvature of the subject's skull. The housing 408
can be secured to the subject's skull with a screw 410.
[0044] The housing 408 can include a pass-through port 414. The
pass-through port 414 can be configured to receive and hold the
lead 106 or body thereof. The pass-through port 414 can include a
lip 416 that mates with the burr hole (in the subject's skull)
through which the lead 106 is implanted into the subject's brain.
For example, the lip 416 can extend between about 1 mm and about 5
mm below the portion of the housing 408 including the pass-through
port 414. The outer diameter of the lip 416 can be substantially
the same or slightly less than the inner diameter of the burr hole
such that the lip 416 can be press fit into the bur hole by the
implanting surgeon.
[0045] The pass-through port 414 can be used to stabilize and
secure the lead 106. The pass-through port 414 can be used to seal
the burr hole. For example, the pass-through port 414 can include a
flexible material that includes a slit. The lead 106 can
pass-through the slit in the flexible material, which can seal
around the lead 106. The sealed flexible material can prevent
contaminants from entering the burr hole and can be implemented as
an elastomer or polymer, such as a medical grade Silicone. The
housing 408 can also include a burr hole cap that can cover and
seal the pass-through port 414.
[0046] FIGS. 7A and 7B illustrate an example recording patch 100.
FIG. 7A illustrates a top view of the recording patch 100. FIG. 7B
illustrates a perspective view of the recording patch 100.
Referring to FIGS. 7A and 7B together, the recording patch 100 can
include a housing 700 that is coupled with the subject's skull via
an anchor 702. The housing 700 can include ports 704(1)-704(3),
which can be referred to as ports 704.
[0047] The components of the recording patch 100 can be enclosed
within the housing 700. For example, the housing 700 can house a
controller 406 and the antenna 404 as described above in relation
to FIG. 6, among others. The housing 700 can be manufactured from
plastic or be a hermetically sealed titanium case. The housing 700
can be molded around the components of the recording patch 100. The
housing 700 can include one or more electrode sites to enable the
housing 700 to be used as a ground or reference for the recordings
made at the lead 106. The housing 408 can be metal and the housing
408 itself can be used as a ground or reference electrode.
[0048] The housing 700 can be configured in a "radial" or "spoke
and hub" configuration. In these configurations, the housing 700
can include a plurality of spokes 706 that radiate out from a
central hub 708. Each of the spokes 706 can terminate with or
otherwise include at least one port 704. The housing 700 can
include between about 2 and about 10, between about 2 and about 8,
between about 2 and about 6, or between about 2 and about 4 spokes
706.
[0049] The recording patch 100 can include a plurality of spokes
706. Each spoke 706 can include one or more ports 704. Each spoke
706 may include only input ports 704 or only output ports 704, or a
combination thereof. Each port can include between about 2 and
about 64, between about 2 and about 32, or between about 2 and
about 12 contacts to make an electrical connection with the
contacts of leads 106 or cables 108. The spokes 706 or a portion
thereof can be flexible to enable the recording patch 100 to
conform to the shape of the subject's skull. For example, the
distal portion of the spokes 706 can include a strain relief that
enables flexing at or near the ports 704. The recording patch 100
can include a flexible or mechanical joint at the connection
between the spokes 706 and the hub 708 to enable the spokes 706 to
deflect and conform to the shape of the subject's skull. The spokes
706 can project from the hub 708 at a predetermined angle to
conform to the shape of the subject's skull. The housing 700, from
a side profile, can include a convex shape that enables the
recording patch 100 to be secure against the subject's skull. The
convex shape of the recording patch 100 can substantially match the
curvature of the subject's skull. The housing 700 can be flexible
to conform to the curvature of the subject's skull.
[0050] The recording patch 100 can include a plurality of ports
704. The recording patch 100 can include one or more input ports
704 and one or more output ports 704. The input ports 704 can
electrically couple with the pulse generator 102 and the output
ports 704 can electrically couple with the leads 106. For example,
a port 704 can receive a connection from the cable 108. The ports
704 can be similar to the ports 400 described above in relation to
FIG. 4. For example, the ports 704 can each include connections 402
that make electrical contact with the contacts of the lead 106 or
the cable 108. The ports 704 can include one or more screws 410 to
secure a cable 108, cable to a lead 106, or other cable to the
ports 704.
[0051] The output ports 704 can electrically couple with a lead
106. The ports 704 (both the input or output ports 704) can be
female or male ports. For example, the input port 704 can be a
female port and the output ports 704 can be male ports. The output
ports 704 can include a cable tether. The cable tether can include
a connector to couple the lead 106 with the recording patch 100.
The leads 106 can be permanently coupled with the output ports 704.
For example, a cable can extend from the ports 704. The distal end
of the cable can include the lead 106. The lead 106 can be
permanently coupled with an output port 704 when the cable or port
704 does not include a connector that enables the lead 106 to be
disconnected form the recording patch 100.
[0052] The recording patch 100, as illustrated in FIGS. 7A and 7B
can include an anchor 702. The anchor 702 can be a component that
separates from the housing 700. For example, the anchor 702 can be
a separate bracket that a medical professional can use to couple
the recording patch 100 to the subject's skull. The anchor 702 can
be an integral portion of the housing 700. For example, the anchor
702 cannot be separated from the housing 700. The anchor 702 can
include a plurality of arms 710. The arms 710 can extend between
each of the spokes 706. The arms 710 can terminate with an anchor
point. The anchor point can be an opening or hole to receive a
screw 410. A screw 410 can be placed through each of the anchor
points and screwed into the subject's skull to couple the recording
patch 100 to the subject's skull. The anchor 702 can include a
medical grade metal, such as stainless steel or titanium
[0053] FIG. 8 illustrates a block diagram of an example schematic
of the system 50. The system 50 can include the recording patch 100
and a programmer 800, which can be more generally referred to as an
external source or a transmitter and receiver. The recording patch
100 can include the controller 406, which can include a recording
module 802 and a selector module 804. The recording patch 100 can
include switches 806 that can interconnect the controller 406 and
ports 400. The recording patch 100 can include a power source 808
and the antenna 404. The system 50 can include the programmer 800.
The programmer 800 can include an instance of the selector module
804, an antenna 404, and a memory element 810. The recording patch
100 can include the controller 406. The controller 406 can include
the recording module 802. The recording module 802 can include a
plurality of amplifiers. For example, the recording module 802 can
include an amplifier for each of the lead's channels.
[0054] The controller 406 can be an application specific integrated
circuit (ASIC). Each of the electronic components of the recording
patch 100 can be components of the controller 406. For example, the
switches 806, the antenna 404, and the power source 808 can each be
components of controllers ASIC. The controller 406 and components
of the recording patch 100 can be divided among a plurality of
ASICs.
[0055] The recording module 802 can pass the incoming signals from
the lead 106 through its amplifiers to generate amplified signals
based on the incoming signals. The amplifiers can have a gain
between about 50 times to 5000 times, or between about 60 dB-120
dB. The recording module 802 can digitize the amplified signals.
The recording module 802 can digitize the signals at a rate of
between about 10 Hz and about 2000 Hz, between about 50 Hz and
about 1000 Hz, or between about 50 Hz and about 20,000 Hz. The
recording module 802 can perform pre-processing on the original or
amplified signal. The pre-processing can include applying low,
high, or band pass filters. For example, the recording module 802
can band pass the original signal to remove electrical noise. The
recording module 802 can band pass filter the signals to remove all
but desired frequency ranges or bands. For example, the recording
module 802 can filter the signals to remove frequencies in the
signals above about 100 Hz, 250 Hz, or about 500 Hz.
[0056] The recording module 802 can communicate with the programmer
800 via the antenna 404. The recording module 802 can transmit the
amplified signal to the programmer 800 via the antenna 404. The
controller 406 can include the selector module 804. The recording
patch 100 and the programmer 800 can each include instances of the
selector module 804. In some examples, only one of the recording
patch 100 or the programmer 800 include an instance of the selector
module 804. For example, only the programmer 800 may include an
instance of the selector module 804 and the recording patch 100 can
transmit data (e.g., electrical signals) to the programmer 800 for
analysis.
[0057] The selector module 804 can select one or more electrodes of
the lead 106 over which a stimulation signal is delivered to the
subject. The selector module 804 can select the electrodes to use
for stimulation based on the signal characteristics of the signals
received from the lead 106. The characteristics can be the amount
of power in a beta band of the received signals. The beta band can
be between about 10 Hz and about 30 Hz, for example. The selector
module 804 can select the electrodes that include the most power in
the beta band as the electrodes to use for stimulation. The
selector module 804 can select the electrode with the highest
amount of power in the beta band as a stimulating electrode. The
selector module 804 can select the electrodes having power in the
beta band over a predetermined threshold as the stimulating
electrodes. In some implementations, the electrode with the most
power in the beta band can be selected. If a plurality of
electrodes have power in the beta band, each of the plurality of
electrodes can be selected as a multitude. If a multitude of
electrodes is selected they may stimulate at the same signal
amplitude, or at different signal amplitudes. If at different
signal amplitudes, the individual single amplitudes applied to each
electrode may be chosen to be proportional to the power of beta
band detected. For example, if two electrodes display beta band
power upon recording, with a first electrode demonstrating twice as
much power as a second electrode, the signal amplitude for each
electrode would be chosen such that the first electrode would have
a signal amplitude twice as that of the second electrodes. In
another use scenario, the signal amplitude could be applied between
two or more electrodes that have each demonstrated beta band
power.
[0058] The recording patch 100 can include a plurality of switches
806. The switches 806 can be components of the controller 406. The
switches 806 can selectively interconnect the connections in the
port 400 leading to the pulse stimulator 102 to the connections in
the port 400 leading to the lead 106. The switches 806 can
selectively interconnect the connections in the port 400 leading to
the lead 106 to the recording module 802. Selectively
interconnecting, via the switches 806, can include connecting any
of a port's connections to any input pins of the controller 406 or
other connections of another port 400. In some implementations, the
switches can be implemented as mechanical relays, micromechanical
MEMS relays, electrical switches such as JFET, MOSFET, or other FET
technology, or other microfabrication technology. In some
embodiments, no switches are necessary, but a high impedance input
to the recording module would be required. From this input a
recording signal with high signal to noise can be captured, but
stimulation signal from the pulse generator 102 would not sink.
[0059] The controller 406 can control the switches 806 to put the
recording patch 100 into a recording mode or a pass-through mode.
For example, the controller 406 can control the opened or closed
state of the switches 806. During a pass-through mode, the switches
806 can couple the connections of a first port 400 with the
connections of a second port 400. The pass-through mode can enable
stimulation signals from the pulse stimulator 102 to pass through
the recording patch 100 and to the lead 106 without substantial
alteration at the recording patch 100.
[0060] During a recording mode, the switches 806 can couple the
connections of the port 400 coupled with the lead 106 with the
controller 406. The switches 806 can couple each of the lead's
electrodes with the controller 406 or only a portion thereof.
[0061] The recording patch 100 can include a power source 808. The
power source 808 can be a rechargeable battery. The power source
808 can include a super capacitor. The power source 808 can be
recharged wirelessly via the programmer 800. For example, the
antenna 404 of the programmer 800 and the recording patch 100 can
inductively couple to provide the recording patch 100 with power.
The power can be passed to the power source 808 to charge the power
source 808.
[0062] The programmer 800 can be an external data processing
system. The programmer 800 can be a stand-alone device. The
programmer 800 can be a mobile device such as a laptop, tablet, or
smart phone. The programmer 800 can read and write data to the
recording patch 100 through wireless communication with the
recording patch 100 using the antennas 404. For example, the
programmer 800 can receive and store digitized biological signals
from the recording patch 100. The programmer 800 can transmit
configuration information, such as which connections of the ports
to interconnect, to the recording patch 100.
[0063] The programmer 800 can include a screen to provide visual
information to the user. The information can include readouts of
the electrical signals received at each of the lead's electrodes,
power within specified bands (e.g., the beta band) of the signals,
or settings (e.g., which electrodes are configured as stimulation
electrodes). The screen can be a touch screen. The programmer 800
can include an antenna 404 that can be inductively coupled with the
antenna 404 of the recording patch 100 to transmit data and power
to between the devices. Via the screen the selector module 804 can
display one or more characteristics of the received signals. Via
the screen the selector module 804 can display plots of power
within, for example, the beta band. Via the screen the selector
module 804 can display indications or approximations of the
signals' characteristics. For example, the selector module 804 can
indicate whether a given channel has a "low," "medium," or "high"
level of power in the beta band.
[0064] The programmer 800 can include an antenna 404. The antenna
404 of the programmer 800 can have a diameter that provides
efficient communication with the patch 100 via the antenna 404 of
the patch 100. For example, the antenna 404 of the programmer 800
can have a diameter between about 25 mm and about 85 mm or between
about 45 mm and about 55 mm while the antenna 404 of the patch 100
can have a diameter between about 15 mm and about 35 mm or between
about 20 mm and about 30 mm. The programmer 800 can communicate
with the patch 100 wirelessly after the implantation of the patch
100. The programmer 800 can send data to the patch 100 in order to
set the recording parameters that the patch 100 uses to record
electrical signals via the lead 106. For example, the programmer
800 can set which electrodes are used for the recording and the
sampling frequency that is used to make the recording.
[0065] The programmer 800 can download data (e.g., usage data,
recorded physiological data, or device configuration information)
from the patch 100. The programmer 800 can receive the data from
the patch 100 in substantially real time (e.g., the data can be
streamed to the programmer 800 from the patch 100). The patch 100
can transmit the data to the programmer 800 in batches. For
example, the patch 100 can include an on-board memory to which the
recordings from the lead 106 are stored and then downloaded or
transmitted to the programmer 800. Once received by the programmer
800, the programmer 800 can store the data on the memory 810. A
user can later download the recording data from the memory 810 to a
data processing system for analysis. The programmer 800 can perform
all or portions of analysis performed by the data processing
system.
[0066] The programmer 800 can be used to recharge the internal
batteries of the patch 100. For example, the antenna 404 of the
programmer 800 can be used to inductively couple power from an
external power source to the patch 100. In some implementations,
the patch 100 can have no internal power source and inductive power
from the programmer 800 can be used to power the patch 100.
[0067] The programmer 800 can include an instance of the selector
module 804. The programmer's selector module 804 can perform any of
the functions performed by the recording path's selector module
804. For example, the selector module 804 can calculate
characteristics of the signals detected by the leads 106 and select
one or more electrodes of the lead 106 over which a stimulation
signal is delivered to the subject. The selector module 804 can
select the electrodes to use for stimulation based on the signal
characteristics of the signals received from the lead 106. The
characteristics can be the amount of power in a beta band of the
received signals. The beta band can be between about 10 Hz and
about 30 Hz, for example. The selector module 804 can select the
electrodes that include the most power in the beta band as the
electrodes to use for stimulation. The selector module 804 can
select the electrode with the highest amount of power in the beta
band as a stimulating electrode. The selector module 704 can select
the electrodes having power in the beta band over a predetermined
threshold as the stimulating electrodes.
[0068] FIG. 9A illustrates a block diagram of an example method 900
to record biological signals. The method 900 can include implanting
a recording patch (ACT 902). The method 900 can include coupling a
plurality of connections with a recording module (ACT 904). The
method 900 can include receiving biological signals (ACT 906) and
generating amplified signals (ACT 908). The method 900 can include
determining characteristics of the signals (ACT 910). The method
900 can include selecting electrodes (ACT 912).
[0069] The method 900 can include implanting a recording patch (ACT
902). The recording patch can be any of the recording patches
described herein. The recording patch can be implanted into a
subject. The recording patch can include a first port that is
configured to receive a connection from an implantable pulse
stimulator. The first port can include a first plurality of
connections. The recording patch can include a second port that can
be configured to receive a connection from an implantable lead that
is implanted into the subject. The lead can include a plurality of
electrodes. The second port can include a second plurality of
connections. The recording patch can include a plurality of
switches that can be in electrical communication with the first
plurality of connections and the second plurality of connections.
The recording patch can include a recording module that is executed
by one or more processors of the recording patch. The recording
patch can include an instance of a selector module.
[0070] The recording patch can be implanted beneath the subject's
scalp following the implantation of one or more leads into the
subject's brain. The leads can include a plurality of electrodes.
The lead can include a plurality of electrodes positioned around
the circumference of the lead at plurality of different axial
locations. For example, at a plurality of different axial locations
along the body of the lead's body, the lead can include an
electrode at 0, 120, and 240 degrees. The lead can be implanted
such that the lead's electrodes are positioned within the subject's
subthalamic nucleus.
[0071] The method 900 can include coupling a plurality of
connections with a recording module (ACT 904). The patch 100 can
include a first and a second port. One port can be coupled with an
implanted lead and be referred to as a lead port and one port can
be coupled with an implanted stimulator and be referred to as a
stimulator port. At a first time point after the implantation of
the recording patch, the recording patch can wirelessly receive
instructions that place the recording patch in a recording mode. In
the recording mode, the recording patch's switches can couple one
or more of the lead port's connections to the recording module.
During the recording mode, the recording patch can inductively
couple with a programmer or other external source to wirelessly
receive power that powers the recording patch.
[0072] At a second time point before or after the recording patch
collects recordings of biological signals from the subject, the
recording patch can receive instructions can cause the recording
patch to configure one or more of the switches in a pass-through
configuration such that the switches couple connections of the lead
port with connections of the stimulator port. In a pass-through
configuration, the connections between the first port and the
second port can bypass the recording module and stimulation signals
can be delivered to the subject prior to or after the recording
phase.
[0073] The method 900 can include receiving biological signals (ACT
906). During the recording mode, the recording patch can receive
biological signals. The recording patch can receive the biological
signals via the one or more electrodes that are connected to the
lead port's connections to pass the biological signals to the
recording module. The biological signals can be electrical activity
generated by the brain or other neurological tissue. For example,
the biological signals can be LFPs.
[0074] The subject can perform physical acts during the receiving
and recording of the biological signals. For example, the subject
can perform one or more of, but not limited to, the following acts
on one side or both sides of the body simultaneously: general
movement, rest entire body, moving upper limbs, moving fingers,
moving wrists, moving elbows, moving lower limbs, moving toes,
moving ankles, moving knees, moving thighs, moving hips, moving
extremities, moving head, moving neck, talking, clearing throat,
swallowing, coughing, and speaking.
[0075] The method can include generating amplified signals (ACT
908). The patch can include one or more amplifies. The patch can
pass the biological signals through the amplifies to generate
amplified signals. The amplifiers can have a gain of between about
50 and about 5000.times. or between about 60 dB and about 120 db.
The recording patch can sample the biological signals at between
about 1 kHz and about 32 kHz, between about 8 kHz and about 32 kHz,
between about 12 kHz and about 32 kHz, or between about 24 kHz and
about 32 kHz.
[0076] The recording patch can perform pre-processing on the
biological signals or the amplified signals. The pre-processing can
include band pass filtering, high or low pass filtering, smoothing,
down sampling, up sampling, or a combination thereof. For example,
the signals can be band pass with a filter having a pass band
between about 5 Hz and about 5 kHz. The pre-processing can include
applying a notch filter (at about 50 Hz or about 60 Hz) to remove
power-line noise. The recording patch can perform the
pre-processing digitally once the biological signals are digitized
by the recording module or by one or more analog filters that can
process the biological signals prior to the digitization of the
biological signals.
[0077] The method 900 can include determining characteristics of
the signals (ACT 910). The characteristics of the signals can be
determined by the recording patch's recording module or selector
module. The recording patch's controller can determine the
characteristics of the biological signals or the amplified signals.
The recording patch can also wirelessly transmit the amplified
signal to an external device (e.g., a programmer or other device)
that can determine the characteristic of the signals. An instance
of the selector module executed by the recording patch and an
instance of the selector module executed by a programmer can
cooperatively work to determine the characteristics of the signals.
For example, the recording patch can perform pre-processing and
filtering and then the programmer's instance of the selector module
can determine the power within the beta band of the signals.
[0078] The characteristic of the signals can be a power level in a
beta band of each of the amplified biological signals. The
recording patch or the external device can divide the amplified
biological signals into a plurality of segments. For example, the
biological signals can be divided into 15 second segments. The
power in each segment can be calculated using the Welch method
using a 1 second Hanning window with a frequency resolution of 1
Hz. The power of different frequency bands can be calculated as the
area under curve of the power spectral density curves. For example,
the recordings can be divided into a plurality of bands, such as
alpha (7.5-12 Hz), low beta (12.5-16 Hz), medium beta (16.5-20 Hz)
and high beta (20.5-30 Hz).
[0079] The method 900 can include selecting electrodes (ACT 912).
The method 900 can include selecting an electrode of the plurality
of electrodes based on the at least one signal characteristic of
the biological signal. For example, the controller or the
programmer can select each of the electrodes that received a
biological signal having a power in the beta band above a
predetermined threshold. The controller or the programmer can
select the electrode that received a biological signal having the
highest power in the beta band. The one or more selected electrodes
can be used as stimulating electrodes. The selector module can
select the electrode at each axial position with the highest power
in the beta band. In some implementations, the selector module can
select a plurality of electrodes. For example, the selector module
can select the plurality of electrodes with the two, three, etc.
highest level of power in the beta band.
[0080] At a time point after the stimulating electrodes are
selected, the recording patch can connect the implantable pulse
stimulator to the selected electrodes. For example, the connections
electrically coupled with the pulse stimulator can be coupled with
the connections at the lead port that are in electrical
communication with the selected electrodes. The recording patch can
place the switches in a pass-through configuration such that the
switches couple the connections of the two ports together while
bypassing the controller.
[0081] When in the pass-through configuration, the pulse stimulator
can generate a stimulation signal that is transmitted to the
selected leads via the recording patch. Once the patch is
configured into the pass-through configuration, the external power
supply from the recording patch can be removed. The external power
supply can be removed prior to transmitting the stimulation signal
to the electrodes selected as stimulation electrodes. The acts of
the method 900 can be repeated at predetermined time points or
intervals. For example, during doctor visits the physician can
place the recording patch into a recording mode to retrieve
electrical signals from each of the electrodes and the selector
modules can re-determine which of the electrodes are receiving
electrical signals with the highest power in the beta band. During
different iterations of the method 900, different electrodes can be
selected as stimulating electrodes. For example, during a first
iteration of the method 900 a first plurality of the electrodes can
be selected as stimulation electrodes. At another time point during
a second iteration of the method 900 a second plurality of
electrodes (which can be a subset of the first plurality of
electrodes or a different plurality of electrodes) can be selected
and coupled with the recording module.
[0082] FIG. 9B illustrates a block diagram of an example method 920
to receive biological signals. The method 920 can be used in
conjunction with the ACTs of the method 900. For example, the
method 920 can be used at ACT 908 of the method 900. The method 920
can include collecting resting signals (ACT 922). The method 920
can include asking a subject to perform an action (ACT 924). The
method 920 can include collecting signals during the action (ACT
926). The method 920 can include determining whether the subject
should perform another activity (ACT 928). The method can include
stimulating the subject (ACT 930). The method 920 can include
receiving biological signals (ACT 932).
[0083] As set forth above, the method 920 can include collecting
resting signals (ACT 922). The signals can be biological signals.
For example, the biological signals can be electrical activity
generate by brain or other neurological tissue. For example, the
biological signals can be LFPs. The subject can be asked to relax
or otherwise not move as the resting signals are collected. For
example, the subject can be asked to recline, sit, or lie down as
the recording patch collects the signals. To record the signals,
the programmer can set the recording patch to the recording mode.
The recording patch can receive the biological signals via the one
or more electrodes of the lead. The recording patch can collect or
otherwise record the resting signals as the subject rests (e.g.,
does not substantially move). The recording patch can collect the
resting signals at a predetermined time interval after the subject
begins to rest. For example, the subject can be asked to recline
and the recording patch can begin to collect the resting signals
about 1 minute, 5 minute, 10 minutes, or 15 minutes after the
subject begins to recline.
[0084] The method 920 can include asking the subject to perform an
activity (ACT 924). A medical professional can request that the
subject perform an activity or action when prompted by the
programmer. The activity can include moving certain parts of the
body, walking, turning, standing, coughing, speaking, throat
clearing, swallowing, blinking, winking, squinting, performing hand
gestures, performing finger gestures, performing elbow movements,
performing shoulder movements, breathing, or halting the breath,
among others. The medical professional can ask the subject to
physically perform the activity or the medical professional can ask
the subject to visualize or imagine performing the activity.
[0085] The method 920 can include collecting signals during the
activity (ACT 926). The signals can be biological signal as
described above in relation to ACT 922. The biological signal can
be collected as the subject performs (physically or mentally) the
activity of ACT 924. The signals can be recorded immediately
following the completion of activity. For example, the recording
patch can record the signals 1 min, 5 min, 10 min, 15 min, or 30
min after the completion of the activity. The biological signals
recorded at ACT 922 and ACT 926 can be continuously recorded during
a testing session. For example, the recording patch can be placed
into a recording mode prior to the medical professional asking the
subject to rest and then continue recording through the ACTS of the
method 920. The medical professional or the programmer can annotate
the recorded signal to indicate the transitions between different
phases of the testing session. For example, via the programmer, the
medical professional can indicate when the subject begins to rest
and when the subject begins or ends the activity. The programmer
can record the time of the indication or can set a flag in the
recorded signal to indicate each of the transitions.
[0086] The method 920 can include determining whether to test
another activity (ACT 928). The programmer can be loaded with
testing policy that can indicate the one or more activities that
the subject should perform during the method 920. A medical
professional can select or configure the activities stored in the
testing policy. The programmer can determine whether there are
additional activities to ask the subject to perform. If there are
additional activities to perform, the method 920 can return to the
ACT 922. For example, determining there are additional activities
to perform, the programmer can display a message to the medical
professional to request that the medical professional ask the
subject to rest. After the recording patch records additional
resting signals (e.g., repeats ACT 922), the programmer can request
that the medical professional instruct the subject to perform the
next activity listed in the testing policy (e.g., repeats ACT 924).
The recording patch can collect the signal during or after the
subject completes the next activity listed in the testing policy
(e.g., repeats ACT 926). The method 920 can include repeating the
ACTs 922-926 until the programmer determines there are no more
additional activities in the testing policy for the subject to
perform.
[0087] The method 920 can include stimulating the subject via the
lead (ACT 930). Also referring to FIG. 1, among others, the
programmer can send an instruction to the recording patch to place
the recording patch in a pass-through mode, such that electrical
stimulations from the pulse stimulator 102 can pass from the pulse
stimulator 102 to the lead 106. As described above, the lead 106
can include a plurality of electrodes. The pulse stimulator 102 can
individually address each of the plurality of electrodes. The
programmer can select one or more of the plurality of electrodes to
which the stimulation should be delivered from the pulse stimulator
102. For example, the pulse stimulator 102 can include a plurality
of internal switches that can be opened or closed to electrically
disconnect or connect, respectively, an electrode from a
stimulation source of the pulse stimulator 102. The pulse
stimulator 102 can deliver the stimulation single to one electrode,
a plurality of electrodes, or all of the electrodes of the lead
106.
[0088] The method 920 can include receiving biological signals (ACT
932). To receive biological signals, the programmer can place the
recording patch back into the recoding mode. The recording patch
can receive the biological signals via the one or more electrodes
that are connected to the lead port's connections to pass the
biological signals to the recording module. The biological signals
can be electrical activity generate by brain or other neurological
tissue. For example, the biological signals can be LFPs. The
recording patch can receive or otherwise record the biological
signal starting at the completion of the stimulation signal
delivered at ACT 930. The recording patch can continue to record
the biological signals for between about 1 min and about 30 min,
between about 1 min and about 20 min, or between about 1 min and
about 15 minutes following the completion of the stimulation
signal. The ACT 930 and the ACT 932 can be repeated a plurality of
times. For example, the ACT 930 and ACT 932 can be repeated for
each electrode of the leads 106.
[0089] The method 920 can include determining characteristics of
the recorded signal at different time points. For example, the
characteristics of the biological signal post-stimulation or
post-activity can be compared to the characteristics of the
biological signal recording during ACT 922 when the subject was at
rest. The characteristics of the signals can be determined by the
recording patch's recording module or selector module. The
recording patch's controller can determine the characteristics of
the biological signals. Determining the characteristics is further
described in relation to FIGS. 10-14, among others. The recording
patch can also wirelessly transmit the amplified signal to an
external device (e.g., a programmer or other device) that can
determine the characteristic of the signals. An instance of the
selector module executed by the recording patch and an instance of
the selector module executed by a programmer can cooperatively work
to determine the characteristics of the signals. For example, the
recording patch can perform pre-processing and filtering and then
the programmer's instance of the selector module can determine the
power within the beta band of the signals. The characteristic of
the recorded signal can be the amount of power in a beta-band of
the recorded signal. For example, the recording patch's controller
can determine the change in the amount of power in the beta-band
between the resting phase (e.g., during ACT 922) and the amount of
power in the beta-band after the stimulation signal is provided to
the subject (e.g., during ACT 932).
[0090] FIGS. 10-13 illustrate the results of recordings made with a
system similar to that described herein. FIG. 10 illustrates a plot
1000 of a plurality of power spectral densities 1002. Each of the
power spectral densities 1002 was generated from 30-second
recordings for both moving conditions (top row) and resting
conditions (bottom row). Each recording was split into fifteen
two-second epochs to examine changes in power spectral densities
over time. Across the conditions and subjects, no marked change was
observed over time. Differences were primarily observed between
subjects in terms of peak frequency (e.g., the frequency component
with most signal energy) and in terms of directions. For example,
for subject 1 during moving, peak power was concentrated between
about 25 and about 30 Hz. Subject 2 showed peak power during moving
and resting between frequencies about 17 and about 27 Hz. For
subject 3, peak power was concentrated in a narrow band around 8
Hz. Subject 4 had peak spectral densities between about 8 and about
15 Hz.
[0091] FIG. 11 illustrates a plot 1100 of power spectral densities
for each of four subjects. The plot 1100 includes separate power
spectral densities form the different lead electrodes pointed in
the antero-lateral, medial, and postero-lateral directions. The
plot 1100 illustrates that the four subjects experienced
directional difference. For example, during moving, subject 1 had
peak power in the antero-lateral and medial directions with
slightly less power in the postero-lateral direction. Subject 2
showed peak power in the antero-lateral direction with visibly more
power than in the medial or postero-lateral direction. During
moving, subject 3 had most power in the medial direction. Subject 4
had increased power below 10 Hz in all three directions during
moving, but concentrated spectral power in the medial direction
during resting.
[0092] During resting, the power spectral densities showed more
directional differences than during moving. For example, subjects
1, 2, and 3 had heightened activity in the antero-lateral direction
with peak power at 27 Hz, 22 Hz and 9 Hz, respectively. Subject 4
showed increased activity at 10 Hz in the medial direction.
[0093] The power spectral densities were stored as ranked
stimulation directions (e.g., 1st, 2nd, and 3rd best direction) and
split the power spectral densities into four frequency bands (e.g.,
alpha, low beta, medium beta, and high beta). The directions were
ranked from the highest beta activity to the lowest beta
activity.
[0094] FIG. 12 illustrates a plot 1200 comparing different
frequency bands to different stimulation directions. In each of the
six plotted examples, the 1st best direction had more power than
the 2nd and 3rd best directions. However, in half of the cases
these directional differences between directions were not
significant. For instance, no significant difference was observed
in the alpha frequency band or in the low beta frequency band
during moving and resting. Significant differences were detected in
the medium and high beta frequency bands and were more pronounced
in the high beta frequency band and was particularly marked during
resting.
[0095] FIG. 13 illustrates a comparison 1300 of the spectral power
for the two conditions in the different frequency bands. The first
condition is moving and the second condition is resting. The
comparison 1300 illustrates that subjects 1 and 2 had most power
during resting across the four frequency bands, while subjects 3
and 4 had no preferable condition. For the medium beta frequency
band, moving and resting had similar power in these two
subjects.
[0096] The above plots in FIGS. 10-13 illustrate that the power
spectral densities showed relevant activity between about 8 Hz and
about 30 Hz. The beta band can be linked with motor functions and
Parkinson's disease can be linked with an increase in beta
oscillations in the subthalamic nucleus. On average the highest
spectral power for medium and high beta bands was observed in the
direction matching the 1st best stimulation direction, e.g., the
direction with the largest therapeutic window.
[0097] FIG. 14 illustrates an example heat map 1400 to illustrate
the amount of beta activity recorded at each of the electrodes of
the lead during a plurality of activities. The heat map 1400 can
indicate the relative amount of beta activity recorded at each of
the plurality of electrodes 1406. The amount of beta activity can
be calculated or otherwise determined as described above in
relation to FIGS. 9A-13, among others. For example, the recording
patch can record neurological activity as the subject performs a
plurality of activities as described in relation to FIG. 9B. As
illustrated in FIG. 14, a test was performed where the amount of
beta activity was identified at 6 different electrodes 1406. The
electrodes 1406 can correspond to 6 electrodes of the lead 106. The
controller can determine the beta activity as (or immediately
after) the subject performs one of a plurality of activities 1402.
The heat map 1400 can group the activities 1402 into groups 1404.
The activities 1402 can be grouped based on the region of the body
that is activated when performing the respective activity. For
example, the movement of the arm, bending of the wrist, and
movement of the fingers can be grouped into a group called "upper
limbs." As illustrated in FIG. 14, the heat map 1400 illustrates
the amount of beta activity as the subject: is at rest; talking,
clearing the throat; and swallowing (the "mouth" group); moving the
arm, bending the wrist, and moving the fingers (the "upper limb"
group); and walking, bending the leg, and rolling the ankle (the
"lower limb" group).
[0098] The heat map 1400 can be a matrix that visually illustrates,
for each electrode 1406--activity 1402 combination, a value 1408 of
beta activity detected by the recording patch. The value 1408 can
be a color-coded indicator or a value-coded indicator. For example,
as illustrated in FIG. 14, relatively low beta activity can be
indicated by a lightly colored box and a relatively high beta
activity can be indicated by a darkly colored box. The heat map
1400 can use any color mapping or other visual representation of
values. For example, for a value-coded indicator, the value 1408
can be a scored value between 1 and 10 or a relative term such as
"high," "medium," or "low." For each value 1408, the controller can
normalize the value 1408 between 0 and 1 (or other value). For
example, the controller can set the highest beta activity value
1408 of the electrode-activity combinations to 1 and the lowest
beta activity value 1408 of the electrode-activity combinations to
0. The values between the highest and lowest electrode-activity
combinations can be scaled between 0 and 1. The scaling can be
linear, logarithmic, binary, normalized, or non-linear.
[0099] As illustrated in FIG. 14, directional electrodes 2 and 3
demonstrated a relatively high beta activity within the mouth and
upper limb groups, respectively. Electrodes 1, 5, and 6 also
demonstrated beta activity to a lesser extent. Electrode 4 did not
demonstrate any beta activity. Based on the heat map 1400, the
programmer could therefore conclude that directional electrode 2
may cause side effects linked to the mouth and throat region.
However, the programmer could conclude that electrode 4 would be a
good candidate for use in stimulation because of the low beta
activity detected for each of electrode 4's electrode-activity
combinations.
[0100] While operations are depicted in the drawings in a
particular order, such operations are not required to be performed
in the particular order shown or in sequential order, and all
illustrated operations are not required to be performed. Actions
described herein can be performed in a different order.
[0101] The separation of various system components does not require
separation in all implementations, and the described program
components can be included in a single hardware or software
product.
[0102] Having now described some illustrative implementations, it
is apparent that the foregoing is illustrative and not limiting,
having been presented by way of example. In particular, although
many of the examples presented herein involve specific combinations
of method acts or system elements, those acts and those elements
may be combined in other ways to accomplish the same objectives.
Acts, elements and features discussed in connection with one
implementation are not intended to be excluded from a similar role
in other implementations or implementations.
[0103] The phraseology and terminology used herein is for the
purpose of description and should not be regarded as limiting. The
use of "including" "comprising" "having" "containing" "involving"
"characterized by" "characterized in that" and variations thereof
herein, is meant to encompass the items listed thereafter,
equivalents thereof, and additional items, as well as alternate
implementations consisting of the items listed thereafter
exclusively. In one implementation, the systems and methods
described herein consist of one, each combination of more than one,
or all of the described elements, acts, or components.
[0104] As used herein, the term "about" and "substantially" will be
understood by persons of ordinary skill in the art and will vary to
some extent depending upon the context in which it is used. If
there are uses of the term which are not clear to persons of
ordinary skill in the art given the context in which it is used,
"about" will mean up to plus or minus 10% of the particular
term.
[0105] Any references to implementations or elements or acts of the
systems and methods herein referred to in the singular may also
embrace implementations including a plurality of these elements,
and any references in plural to any implementation or element or
act herein may also embrace implementations including only a single
element. References in the singular or plural form are not intended
to limit the presently disclosed systems or methods, their
components, acts, or elements to single or plural configurations.
References to any act or element being based on any information,
act or element may include implementations where the act or element
is based at least in part on any information, act, or element.
[0106] Any implementation disclosed herein may be combined with any
other implementation or embodiment, and references to "an
implementation," "some implementations," "one implementation" or
the like are not necessarily mutually exclusive and are intended to
indicate that a particular feature, structure, or characteristic
described in connection with the implementation may be included in
at least one implementation or embodiment. Such terms as used
herein are not necessarily all referring to the same
implementation. Any implementation may be combined with any other
implementation, inclusively or exclusively, in any manner
consistent with the aspects and implementations disclosed
herein.
[0107] The indefinite articles "a" and "an," as used herein in the
specification and in the claims, unless clearly indicated to the
contrary, should be understood to mean "at least one."
[0108] References to "or" may be construed as inclusive so that any
terms described using "or" may indicate any of a single, more than
one, and all of the described terms. For example, a reference to
"at least one of `A` and `B`" can include only `A`, only `B`, as
well as both `A` and `B`. Such references used in conjunction with
"comprising" or other open terminology can include additional
items.
[0109] Where technical features in the drawings, detailed
description or any claim are followed by reference signs, the
reference signs have been included to increase the intelligibility
of the drawings, detailed description, and claims. Accordingly,
neither the reference signs nor their absence have any limiting
effect on the scope of any claim elements.
[0110] The systems and methods described herein may be embodied in
other specific forms without departing from the characteristics
thereof. The foregoing implementations are illustrative rather than
limiting of the described systems and methods. Scope of the systems
and methods described herein is thus indicated by the appended
claims, rather than the foregoing description, and changes that
come within the meaning and range of equivalency of the claims are
embraced therein.
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