U.S. patent application number 16/741258 was filed with the patent office on 2020-05-14 for prescribed neuromodulation dose delivery.
The applicant listed for this patent is Boston Scientific Neuromodulation Corporation. Invention is credited to Ismael Huertas Fernandez, Michael A. Moffitt.
Application Number | 20200147400 16/741258 |
Document ID | / |
Family ID | 70550228 |
Filed Date | 2020-05-14 |
United States Patent
Application |
20200147400 |
Kind Code |
A1 |
Moffitt; Michael A. ; et
al. |
May 14, 2020 |
Prescribed Neuromodulation Dose Delivery
Abstract
Methods and systems for providing stimulation therapy are
disclosed. Embodiments of the system include an implantable
stimulator and an external controller configured to control the
implantable stimulator. A clinician can prescribe a set amount of
stimulation therapy to a patient. The external controller is
programmed with the prescription. As the patient uses the external
controller and the stimulator device the external controller tracks
the amount of stimulation the patient uses. Once the patient has
used all of the prescribed therapy the patient may return to the
clinician for a follow-up appointment.
Inventors: |
Moffitt; Michael A.; (Solon,
OH) ; Huertas Fernandez; Ismael; (Madrid,
ES) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Neuromodulation Corporation |
Valencia |
CA |
US |
|
|
Family ID: |
70550228 |
Appl. No.: |
16/741258 |
Filed: |
January 13, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16738786 |
Jan 9, 2020 |
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16741258 |
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16657560 |
Oct 18, 2019 |
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16738786 |
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16100904 |
Aug 10, 2018 |
10576282 |
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16657560 |
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16460640 |
Jul 2, 2019 |
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16657560 |
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16460655 |
Jul 2, 2019 |
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16657560 |
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62916958 |
Oct 18, 2019 |
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62693543 |
Jul 3, 2018 |
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62544656 |
Aug 11, 2017 |
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62803330 |
Feb 8, 2019 |
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62803330 |
Feb 8, 2019 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/3615 20130101;
A61N 1/3787 20130101; G16H 20/40 20180101; A61N 1/37247 20130101;
A61N 1/36167 20130101; A61N 1/36071 20130101; G16H 40/67
20180101 |
International
Class: |
A61N 1/372 20060101
A61N001/372; A61N 1/36 20060101 A61N001/36; A61N 1/378 20060101
A61N001/378; G16H 40/67 20060101 G16H040/67; G16H 20/40 20060101
G16H020/40 |
Claims
1. A method of providing a prescribed amount of stimulation to a
patient using an implantable stimulator device that is implantable
in the patient and an external controller configured to control the
implantable stimulator device, the method comprising: receiving a
prescription for stimulation, wherein the prescription quantifies
the prescribed amount of stimulation, using the external controller
to instruct the implantable stimulator device to provide
stimulation, tracking the provided stimulation to determine an
amount of provided stimulation, determining a difference between
the prescribed amount of stimulation and the amount of provided
stimulation, wherein the difference indicates the amount of
stimulation remaining on the prescription and/or an amount of the
prescription used, and providing an indication of the
difference.
2. The method of claim 1, wherein the prescribed amount of
stimulation is based on a total amount of actively delivered charge
to be delivered to the patient.
3. The method of claim 1, wherein the prescribed amount of
stimulation is based on a total amount of time that stimulation is
to be provided to the patient.
4. The method of claim 1, wherein the prescribed amount of
stimulation is based on a total number of boluses of stimulation to
be delivered to the patient.
5. The method of claim 4, wherein each bolus of stimulation
comprises a specified duration during which stimulation is to be
delivered to the patient.
6. The method of claim 4, wherein each bolus of stimulation
comprises an amount of actively driven charge to be delivered to
the patient.
7. The method of claim 1, wherein providing an indication of the
difference comprises displaying an indication of the difference on
a user interface of the external controller.
8. The method of claim 1, wherein providing an indication of the
difference comprises sending a message to a remote location.
9. The method of claim 1, wherein receiving a prescription
comprises receiving the prescription from a clinician
programmer.
10. The method of claim 1, wherein the steps of receiving a
prescription, tracking the provided stimulation, and determining a
difference between the prescribed amount of stimulation and the
amount of provided stimulation are performed by the implantable
stimulator device.
11. The method of claim 1, wherein the steps of receiving a
prescription, tracking the provided stimulation, and determining a
difference between the prescribed amount of stimulation and the
amount of provided stimulation are performed by the external
controller.
12. The method of claim 1, further comprising using an external
power supply to provide RF power to the implantable stimulator
device to provide stimulation.
13. The method of claim 12, wherein the external power supply is
part of the external controller.
14. The method of claim 12, wherein the external power supply is
separate from the external controller.
15. A system for providing a prescribed amount of stimulation to a
patient, the system comprising: an implantable stimulator device
that is implantable in the patient and an external controller
configured to control the implantable stimulator device, wherein
the system is configured to: receive a prescription for
stimulation, wherein the prescription quantifies the prescribed
amount of stimulation to be provided by the implantable stimulator
device, provide stimulation, track the provided stimulation and
determine an amount of provided stimulation, determine a difference
between the prescribed amount of stimulation and the amount of
provided stimulation, wherein the difference indicates the amount
of stimulation remaining on the prescription and/or an amount of
the prescription used, and provide an indication of the
difference.
16. The system of claim 15, wherein the steps of receiving a
prescription, tracking the provided stimulation, and determining a
difference between the prescribed amount of stimulation and the
amount of provided stimulation are performed by the implantable
stimulator device.
17. The system of claim 15, wherein the steps of receiving a
prescription, tracking the provided stimulation, and determining a
difference between the prescribed amount of stimulation and the
amount of provided stimulation are performed by the external
controller.
18. The system of claim 15, further comprising a clinician
programmer configured to: determine the prescription for
stimulation, and transmit the prescription for stimulation to
either the implantable stimulator device or the external
controller.
19. The system of claim 18, wherein determining the prescription
for stimulation comprises: receiving a stimulation program
comprising one or more parameters of a stimulation waveform,
receiving one or more inputs indicating an amount of stimulation to
be provided to the patient, and calculating the prescription for
stimulation based on the stimulation program and the one or more
inputs.
20. The system of claim 15, further comprising an external power
supply configured to provide RF power to the implantable stimulator
device for providing stimulation.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a non-provisional application of U.S.
Provisional Patent Application Ser. No. 62/916,958, filed Oct. 18,
2019.
This application is also a continuation-in-part of U.S. patent
application Ser. No. 16/738,786, filed Jan. 9, 2020, which is a
continuation-in-part of U.S. patent application Ser. No.
16/657,560, filed Oct. 18, 2019, which is a continuation-in-part
of; [0002] U.S. patent application Ser. No. 16/100,904, filed Aug.
10, 2018, which is a non-provisional application of U.S.
Provisional Patent Application Ser. Nos. 62/693,543, filed Jul. 3,
2018, and 62/544,656, filed Aug. 11, 2017; [0003] U.S. patent
application Ser. No. 16/460,640, filed Jul. 2, 2019, which is a
non-provisional application of U.S. Provisional Patent Application
Ser. No. 62/803,330, filed Feb. 8, 2019; and [0004] U.S. patent
application Ser. No. 16/460,655, filed Jul. 2, 2019, which is a
non-provisional application of U.S. Provisional Patent Application
Ser. No. 62/803,330, filed Feb. 8, 2019. Priority is claimed to
these above-referenced applications, and all are incorporated by
reference in their entireties.
FIELD OF THE INVENTION
[0005] This application relates to Implantable Medical Devices
(IMDs), generally, Spinal Cord Stimulators, more specifically, and
to methods of control of such devices.
INTRODUCTION
[0006] Implantable neurostimulator devices are devices that
generate and deliver electrical stimuli to body nerves and tissues
for the therapy of various biological disorders, such as pacemakers
to treat cardiac arrhythmia, defibrillators to treat cardiac
fibrillation, cochlear stimulators to treat deafness, retinal
stimulators to treat blindness, muscle stimulators to produce
coordinated limb movement, spinal cord stimulators to treat chronic
pain, cortical and deep brain stimulators to treat motor and
psychological disorders, and other neural stimulators to treat
urinary incontinence, sleep apnea, shoulder subluxation, etc. The
description that follows will generally focus on the use of the
invention within a Spinal Cord Stimulation (SCS) system, such as
that disclosed in U.S. Pat. No. 6,516,227. However, the present
invention may find applicability with any implantable
neurostimulator device system.
[0007] An SCS system typically includes an Implantable Pulse
Generator (IPG) 10 shown in FIG. 1. The IPG 10 includes a
biocompatible device case 12 that holds the circuitry and battery
14 necessary for the IPG to function. The IPG 10 is coupled to
electrodes 16 via one or more electrode leads 15 that form an
electrode array 17. The electrodes 16 are configured to contact a
patient's tissue and are carried on a flexible body 18, which also
houses the individual lead wires 20 coupled to each electrode 16.
The lead wires 20 are also coupled to proximal contacts 22, which
are insertable into lead connectors 24 fixed in a header 23 on the
IPG 10, which header can comprise an epoxy for example. Once
inserted, the proximal contacts 22 connect to header contacts
within the lead connectors 24, which are in turn coupled by
feedthrough pins through a case feedthrough to circuitry within the
case 12, although these details aren't shown.
[0008] In the illustrated IPG 10, there are sixteen lead electrodes
(E1-E16) split between two leads 15, with the header 23 containing
a 2.times.1 array of lead connectors 24. However, the number of
leads and electrodes in an IPG is application specific and
therefore can vary. The conductive case 12 can also comprise an
electrode (Ec). In a SCS application, the electrode leads 15 are
typically implanted proximate to the dura in a patient's spinal
column on the right and left sides of the spinal cord midline. The
proximal electrodes 22 are tunneled through the patient's tissue to
a distant location such as the buttocks where the IPG case 12 is
implanted, at which point they are coupled to the lead connectors
24. In other IPG examples designed for implantation directly at a
site requiring stimulation, the IPG can be lead-less, having
electrodes 16 instead appearing on the body of the IPG for
contacting the patient's tissue. The IPG leads 15 can be integrated
with and permanently connected the case 12 in other IPG solutions.
The goal of SCS therapy is to provide electrical stimulation from
the electrodes 16 to alleviate a patient's symptoms, most notably
chronic back pain.
[0009] IPG 10 can include an antenna 26a allowing it to communicate
bi-directionally with a number of external devices, as shown in
FIG. 4. The antenna 26a as depicted in FIG. 1 is shown as a
conductive coil within the case 12, although the coil antenna 26a
can also appear in the header 23. When antenna 26a is configured as
a coil, communication with external devices preferably occurs using
near-field magnetic induction. IPG may also include a
Radio-Frequency (RF) antenna 26b. In FIG. 1, RF antenna 26b is
shown within the header 23, but it may also be within the case 12.
RF antenna 26b may comprise a patch, slot, or wire, and may operate
as a monopole or dipole. RF antenna 26b preferably communicates
using far-field electromagnetic waves. RF antenna 26b may operate
in accordance with any number of known RF communication standards,
such as Bluetooth, Zigbee, WiFi, MICS, and the like.
[0010] Stimulation in IPG 10 is typically provided by pulses, as
shown in FIG. 2. Stimulation parameters typically include the
amplitude of the pulses (A; whether current or voltage); the
frequency (F) and pulse width (PW) of the pulses; the electrodes 16
(E) activated to provide such stimulation; and the polarity (P) of
such active electrodes, i.e., whether active electrodes are to act
as anodes (that source current to the tissue) or cathodes (that
sink current from the tissue). These stimulation parameters taken
together comprise a stimulation program that the IPG 10 can execute
to provide therapeutic stimulation to a patient.
[0011] In the example of FIG. 2, electrode E5 has been selected as
an anode, and thus provides pulses which source a positive current
of amplitude +A to the tissue. Electrode E4 has been selected as a
cathode, and thus provides pulses which sink a corresponding
negative current of amplitude -A from the tissue. This is an
example of bipolar stimulation, in which only two lead-based
electrodes are used to provide stimulation to the tissue (one
anode, one cathode). However, more than one electrode may act as an
anode at a given time, and more than one electrode may act as a
cathode at a given time (e.g., tripole stimulation, quadripole
stimulation, etc.).
[0012] The pulses as shown in FIG. 2 are biphasic, comprising a
first phase 30a, followed quickly thereafter by a second phase 30b
of opposite polarity. As is known, use of a biphasic pulse is
useful in active charge recovery. For example, each electrodes'
current path to the tissue may include a serially-connected
DC-blocking capacitor, see, e.g., U.S. Patent Application
Publication 2016/0144183, which will charge during the first phase
30a and discharged (be recovered) during the second phase 30b. In
the example shown, the first and second phases 30a and 30b have the
same duration and amplitude (although opposite polarities), which
ensures the same amount of charge during both phases. However, the
second phase 30b may also be charged balance with the first phase
30a if the integral of the amplitude and durations of the two
phases are equal in magnitude, as is well known. The width of each
pulse, PW, is defined here as the duration of first pulse phase
30a, although pulse width could also refer to the total duration of
the first and second pulse phases 30a and 30b as well. Note that an
interphase period (IP) during which no stimulation is provided may
be provided between the two phases 30a and 30b.
[0013] IPG 10 includes stimulation circuitry 28 that can be
programmed to produce the stimulation pulses at the electrodes as
defined by the stimulation program. Thus, the IPG 10 acts as a
power supply to deliver power to the electrodes for providing
stimulation to the patient. Stimulation circuitry 28 can for
example comprise the circuitry described in U.S. Patent Application
Publications 2018/0071513 and 2018/0071520, or described in U.S.
Pat. Nos. 8,606,362 and 8,620,436. These references are
incorporated herein by reference.
[0014] FIG. 3 shows an external trial stimulation environment that
may precede implantation of an IPG 10 in a patient. During external
trial stimulation, stimulation can be tried on a prospective
implant patient without going so far as to implant the IPG 10.
Instead, one or more trial leads 15' are implanted in the patient's
tissue 32 at a target location 34, such as within the spinal column
as explained earlier. The proximal ends of the trial lead(s) 15'
exit an incision 36 and are connected to an External Trial
Stimulator (ETS) 40. The ETS 40 generally mimics operation of the
IPG 10, and thus can provide stimulation pulses to the patient's
tissue as explained above. See, e.g., U.S. Pat. No. 9,259,574,
disclosing a design for an ETS. The ETS 40 is generally worn
externally by the patient for a short while (e.g., two weeks),
which allows the patient and his clinician to experiment with
different stimulation parameters to try and find a stimulation
program that alleviates the patient's symptoms (e.g., pain). If
external trial stimulation proves successful, trial lead(s) 15' are
explanted, and a full IPG 10 and lead(s) 15 are implanted as
described above; if unsuccessful, the trial lead(s) 15' are simply
explanted.
[0015] Like the IPG 10, the ETS 40 can include one or more antennas
to enable bi-directional communications with external devices,
explained further with respect to FIG. 4. Such antennas can include
a near-field magnetic-induction coil antenna 42a, and/or a
far-field RF antenna 42b, as described earlier. ETS 40 may also
include stimulation circuitry 44 able to form the stimulation
pulses in accordance with a stimulation program, which circuitry
may be similar to or comprise the same stimulation circuitry 28
present in the IPG 10. ETS 40 may also include a battery (not
shown) for operational power.
[0016] FIG. 4 shows various external devices that can wirelessly
communicate data with the IPG 10 and the ETS 40, including a
patient, hand-held external controller 45, and a clinician
programmer 50. Both of devices 45 and 50 can be used to send a
stimulation program to the IPG 10 or ETS 40--that is, to program
their stimulation circuitries 28 and 44 to produce pulses with a
desired shape and timing described earlier. Both devices 45 and 50
may also be used to adjust one or more stimulation parameters of a
stimulation program that the IPG 10 or ETS 40 is currently
executing. Devices 45 and 50 may also receive information from the
IPG 10 or ETS 40, such as various status information, etc.
[0017] External controller 45 can be as described in U.S. Patent
Application Publication 2015/0080982 for example, and may comprise
either a dedicated controller configured to work with the IPG 10.
External controller 45 may also comprise a general purpose mobile
electronics device such as a mobile phone which has been programmed
with a Medical Device Application (MDA) allowing it to work as a
wireless controller for the IPG 10 or ETS 40, as described in U.S.
Patent Application Publication 2015/0231402. External controller 45
includes a user interface, including means for entering commands
(e.g., buttons or icons) and a display 46. The external controller
45's user interface enables a patient to adjust stimulation
parameters, although it may have limited functionality when
compared to the more-powerful clinician programmer 50, described
shortly.
[0018] The external controller 45 can have one or more antennas
capable of communicating with the IPG 10 and ETS 40. For example,
the external controller 45 can have a near-field magnetic-induction
coil antenna 47a capable of wirelessly communicating with the coil
antenna 26a or 42a in the IPG 10 or ETS 40. The external controller
45 can also have a far-field RF antenna 47b capable of wirelessly
communicating with the RF antenna 26b or 42b in the IPG 10 or ETS
40.
[0019] The external controller 45 can also have control circuitry
48 such as a microprocessor, microcomputer, an FPGA, other digital
logic structures, etc., which is capable of executing instructions
an electronic device. Control circuitry 48 can for example receive
patient adjustments to stimulation parameters, and create a
stimulation program to be wirelessly transmitted to the IPG 10 or
ETS 40.
[0020] Clinician programmer 50 is described further in U.S. Patent
Application Publication 2015/0360038, and is only briefly explained
here. The clinician programmer 50 can comprise a computing device
51, such as a desktop, laptop, or notebook computer, a tablet, a
mobile smart phone, a Personal Data Assistant (PDA)-type mobile
computing device, etc. In FIG. 4, computing device 51 is shown as a
laptop computer that includes typical computer user interface means
such as a screen 52, a mouse, a keyboard, speakers, a stylus, a
printer, etc., not all of which are shown for convenience. Also
shown in FIG. 4 are accessory devices for the clinician programmer
50 that are usually specific to its operation as a stimulation
controller, such as a communication "wand" 54, and a joystick 58,
which are coupleable to suitable ports on the computing device 51,
such as USB ports 59 for example.
[0021] The antenna used in the clinician programmer 50 to
communicate with the IPG 10 or ETS 40 can depend on the type of
antennas included in those devices. If the patient's IPG 10 or ETS
40 includes a coil antenna 26a or 42a, wand 54 can likewise include
a coil antenna 56a to establish near-filed magnetic-induction
communications at small distances. In this instance, the wand 54
may be affixed in close proximity to the patient, such as by
placing the wand 54 in a belt or holster wearable by the patient
and proximate to the patient's IPG 10 or ETS 40.
[0022] If the IPG 10 or ETS 40 includes an RF antenna 26b or 42b,
the wand 54, the computing device 51, or both, can likewise include
an RF antenna 56b to establish communication with the IPG 10 or ETS
40 at larger distances. (Wand 54 may not be necessary in this
circumstance). The clinician programmer 50 can also establish
communication with other devices and networks, such as the
Internet, either wirelessly or via a wired link provided at an
Ethernet or network port.
[0023] To program stimulation programs or parameters for the IPG 10
or ETS 40, the clinician interfaces with a clinician programmer
graphical user interface (GUI) 64 provided on the display 52 of the
computing device 51. As one skilled in the art understands, the GUI
64 can be rendered by execution of clinician programmer software 66
on the computing device 51, which software may be stored in the
device's non-volatile memory 68. One skilled in the art will
additionally recognize that execution of the clinician programmer
software 66 in the computing device 51 can be facilitated by
control circuitry 70 such as a microprocessor, microcomputer, an
FPGA, other digital logic structures, etc., which is capable of
executing programs in a computing device. Such control circuitry
70, in addition to executing the clinician programmer software 66
and rendering the GUI 64, can also enable communications via
antennas 56a or 56b to communicate stimulation parameters chosen
through the GUI 64 to the patient's IPG 10.
[0024] A portion of the GUI 64 is shown in one example in FIG. 5.
One skilled in the art will understand that the particulars of the
GUI 64 will depend on where clinician programmer software 66 is in
its execution, which will depend on the GUI selections the
clinician has made. FIG. 5 shows the GUI 64 at a point allowing for
the setting of stimulation parameters for the patient and for their
storage as a stimulation program. To the left a program interface
72 is shown, which as explained further in the '038 Publication
allows for naming, loading and saving of stimulation programs for
the patient. Shown to the right is a stimulation parameters
interface 82, in which specific stimulation parameters (A, D, F, E,
P) can be defined for a stimulation program. Values for stimulation
parameters relating to the shape of the waveform (A; in this
example, current), pulse width (PW), and frequency (F) are shown in
a waveform parameter interface 84, including buttons the clinician
can use to increase or decrease these values.
[0025] Stimulation parameters relating to the electrodes 16 (the
electrodes E activated and their polarities P), are made adjustable
in an electrode parameter interface 86. Electrode stimulation
parameters are also visible and can be manipulated in a leads
interface 92 that displays the leads 15 (or 15') in generally their
proper position with respect to each other, for example, on the
left and right sides of the spinal column. A cursor 94 (or other
selection means such as a mouse pointer) can be used to select a
particular electrode in the leads interface 92. Buttons in the
electrode parameter interface 86 allow the selected electrode
(including the case electrode, Ec) to be designated as an anode, a
cathode, or off. The electrode parameter interface 86 further
allows the relative strength of anodic or cathodic current of the
selected electrode to be specified in terms of a percentage, X.
This is particularly useful if more than one electrode is to act as
an anode or cathode at a given time, as explained in the '038
Publication. In accordance with the example waveforms shown in FIG.
2, as shown in the leads interface 92, electrode E5 has been
selected as the only anode to source current, and this electrode
receives X=100% of the specified anodic current, +A. Likewise,
electrode E4 has been selected as the only cathode to sink current,
and this electrode receives X=100% of that cathodic current,
-A.
[0026] The GUI 64 as shown specifies only a pulse width PW of the
first pulse phase 30a. The clinician programmer software 66 that
runs and receives input from the GUI 64 will nonetheless ensure
that the IPG 10 and ETS 40 are programmed to render the stimulation
program as biphasic pulses if biphasic pulses are to be used. For
example, the clinician programming software 66 can automatically
determine durations and amplitudes for both of the pulse phases 30a
and 30b (e.g., each having a duration of PW, and with opposite
polarities +A and -A). An advanced menu 88 can also be used (among
other things) to define the relative durations and amplitudes of
the pulse phases 30a and 30b, and to allow for other more advance
modifications, such as setting of a duty cycle (on/off time) for
the stimulation pulses, and a ramp-up time over which stimulation
reaches its programmed amplitude (A), etc. A mode menu 90 allows
the clinician to choose different modes for determining stimulation
parameters. For example, as described in the '038 Publication, mode
menu 90 can be used to enable electronic trolling, which comprises
an automated programming mode that performs current steering along
the electrode array by moving the cathode in a bipolar fashion.
[0027] While GUI 64 is shown as operating in the clinician
programmer 50, the user interface of the external controller 45 may
provide similar functionality.
[0028] FIG. 6 shows an alternative embodiment of an implantable SCS
system 600 comprising an implanted electrode lead 602 having
electrodes 16 disposed thereon. The SCS system 600 does not use an
implanted IPG to provide power for electrical stimulation. Instead,
power is provided via radio frequency (RF) transmission through the
patient's tissue 32 from an external power supply (EPS) 604. The
EPS has an RF antenna 606 configured to transmit RF power and the
implanted lead 602 comprises an antenna 608 configured to receive
the RF power. The implanted lead 602 also has simple circuitry (not
shown) configured to rectify the RF power and generate pulses. As
with the IPG system described above, the RF-powered system 600 may
use an external controller 45 to control and transmit stimulation
parameters. However, in the system 600, the external controller 45
provides stimulation parameters to the EPS 604, rather than to an
implanted IPG. While the EPS 604 and the external controller 45 are
illustrated as separate units in FIG. 6, the EPS 604 and the
external controller 45 may be combined as a single unit. The
illustrated SCS system 600 has an advantage over the system
illustrated in FIG. 1 in that the system 600 does not require a
surgical procedure to implant an IPG (10, FIG. 1) and tunnel lead
wires (20, FIG. 1) between the IPG and the electrode leads.
However, a disadvantage of the system 600 (FIG. 6) is that the
patient must position the EPS 604 near their tissue any time that
they wish to receive stimulation. The EPS 604 may be carried in a
belt, pouch or other carrying device, for example. Systems as shown
in FIG. 6, which rely on RF energy provided by an EPS are referred
to herein as "RF systems."
SUMMARY
[0029] A method of providing a prescribed amount of stimulation to
a patient using an implantable stimulator device that is
implantable in the patient and an external controller configured to
control the implantable stimulator device is disclosed herein.
According to some embodiments, the method comprises: receiving a
prescription, wherein the prescription quantifies the prescribed
amount of stimulation to be provided by the implantable stimulator
device, using the external controller to instruct the implantable
stimulator device to provide stimulation, tracking the provided
stimulation and determine an amount of provided stimulation,
determining a difference between the prescribed amount of
stimulation and the amount of provided stimulation, wherein the
difference indicates the amount of stimulation remaining on the
prescription and/or an amount of the prescription used, and using
the external controller to provide an indication of the difference.
According to some embodiments, the prescribed amount of stimulation
is based on a total amount of actively delivered charge to be
delivered to the patient. According to some embodiments, the
prescribed amount of stimulation is based on a total amount of time
that stimulation is to be provided to the patient. According to
some embodiments, the prescribed amount of stimulation is based on
a total number of boluses of stimulation to be delivered to the
patient. According to some embodiments, each bolus of stimulation
comprises a specified duration during which stimulation is to be
delivered to the patient. According to some embodiments, each bolus
of stimulation comprises an amount of actively driven charge to be
delivered to the patient. According to some embodiments, using the
external controller to provide an indication of the difference
comprises displaying an indication of the difference on a user
interface of the external controller. According to some
embodiments, using the external controller to provide an indication
of the difference comprises sending a message to a remote location.
According to some embodiments, receiving a prescription at the
external controller comprises receiving the prescription from a
clinician programmer. According to some embodiments, the steps of
receiving a prescription, tracking the provided stimulation, and
determining a difference between the prescribed amount of
stimulation and the amount of provided stimulation are performed by
the implantable stimulator device. According to some embodiments,
the steps of receiving a prescription, tracking the provided
stimulation, and determining a difference between the prescribed
amount of stimulation and the amount of provided stimulation are
performed by the external controller.
[0030] A system for providing a prescribed amount of stimulation to
a patient using an implantable stimulator device that is
implantable in the patient and an external controller configured to
control the implantable stimulator device is described herein.
According to some embodiments, the system is configured to: receive
a prescription for stimulation, wherein the prescription quantifies
the prescribed amount of stimulation to be provided by the
implantable stimulator device, provide stimulation, track the
provided stimulation and determine an amount of provided
stimulation, determine a difference between the prescribed amount
of stimulation and the amount of provided stimulation, wherein the
difference indicates the amount of stimulation remaining on the
prescription and/or an amount of the prescription used, and provide
an indication of the difference. According to some embodiments, the
system further comprises a clinician programmer configured to:
determine the prescription for stimulation, and transmit the
prescription for stimulation to the external controller. According
to some embodiments, determining the prescription for stimulation
comprises: receiving a stimulation program comprising one or more
parameters of a stimulation waveform, receiving one or more inputs
indicating an amount of stimulation to be provided to the patient,
and calculating the prescription for stimulation based on the
stimulation program and the one or more inputs.
[0031] Also disclosed herein is a non-transitory computer-readable
medium executable on an external controller configured to
communicate with an implantable stimulator device, comprising
instructions, which when executed by the external controller,
configure the controller to: receive a prescription for
stimulation, wherein the prescription quantifies a prescribed
amount of stimulation to be provided by the implantable stimulator
device, instruct the implantable stimulator device to provide
stimulation, track the provided stimulation and determine an amount
of provided stimulation, determine a difference between the
prescribed amount of stimulation and the amount of provided
stimulation, wherein the difference indicates the amount of
stimulation remaining on the prescription and/or an amount of the
prescription used, and provide an indication of the difference.
[0032] Also disclosed herein is a method for providing stimulation
to a patient using an implantable stimulator device and an external
controller configured to control the implantable stimulator device,
the method comprising: determining a bolus of stimulation therapy,
wherein the bolus comprises a duration during which stimulation is
applied and after which stimulation is terminated, using the
external controller to instruct the implantable stimulator device
to issue a bolus of stimulation therapy. According to some
embodiments, determining a bolus of stimulation therapy comprises:
issuing a plurality of trial boluses, wherein each trial bolus
comprises a different duration, receiving an indication of
effectiveness of each of the trial boluses, and based on the
indications of effectiveness, determining the best bolus.
[0033] Also disclosed herein is a method for providing stimulation
to a patient using an implantable stimulator device and an external
controller configured to control the implantable stimulator device
(ISD), the method comprising: tracking instances when a patient
uses the external controller to instruct the implantable stimulator
device to issue a bolus of stimulation, wherein the bolus of
stimulation comprises active stimulation for a first period of time
and wherein after the first period of time the ISD provides no
stimulation for a second period of time, correlating the instances
with one or more predictors indicative of a need for stimulation,
determining an occurrence of one or more of the predictors, and in
response to the occurrence, either prompting the patient to issue a
bolus of stimulation or automatically issuing a bolus of
stimulation. According to some embodiments, the one or more
predictors comprises a time of day. According to some embodiments,
the one or more predictors is selected from the group consisting of
a heartrate measurement, a blood pressure measurement, an activity
level, a postural measurement, and a weather condition. According
to some embodiments, the first period of time is ten minutes to
thirty minutes. According to some embodiments, the second period of
time is thirty minutes to twelve hours.
[0034] The invention may also reside in the form of a programed
external device (via its control circuitry) for carrying out the
above methods, a programmed IPG or ETS (via its control circuitry)
for carrying out the above methods, a system including a programmed
external device and IPG or ETS for carrying out the above methods,
or as a computer readable media for carrying out the above methods
stored in an external device or IPG or ETS.
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] FIG. 1 shows an Implantable Pulse Generator (IPG) useable
for Spinal Cord Stimulation (SC S), in accordance with the prior
art.
[0036] FIG. 2 shows an example of stimulation pulses producible by
the IPG, in accordance with the prior art.
[0037] FIG. 3 shows use of an External Trial Stimulator (ETS)
useable to provide stimulation before implantation of an IPG, in
accordance with the prior art.
[0038] FIG. 4 shows various external devices capable of
communicating with and programming stimulation in an IPG and ETS,
in accordance with the prior art.
[0039] FIG. 5 shows a Graphical User Interface (GUI) of a clinician
programmer external device for setting or adjusting stimulation
parameters, in accordance with the prior art.
[0040] FIG. 6 shows an alternative configuration of an SCS system
using an external power supply.
[0041] FIG. 7 shows a system for providing a prescribed amount of
stimulation.
[0042] FIG. 8 shows an algorithm for determining a prescription for
an amount of stimulation.
[0043] FIG. 9 shows a user interface for tracking prescribed
stimulation.
[0044] FIG. 10 shows an algorithm for determining and monitoring
bolus-mode stimulation.
[0045] FIG. 11 shows an algorithm for preemptively issuing a bolus
of stimulation.
[0046] FIGS. 12A-12C show the use of an algorithm for preemptively
issuing a bolus of stimulation.
DETAILED DESCRIPTION
[0047] Generally, when a patient has been identified as a candidate
for neuromodulation therapy, such as spinal cord stimulation (SCS),
the patient receives one or more surgically implanted electrode
leads (such as leads 15, FIG. 1). The leads may then be connected
to an external trial stimulator (ETS 40, FIG. 4), which allows the
patient and his clinician to experiment with different stimulation
parameters to try and find a stimulation program that alleviates
the patient's symptoms (e.g., pain). If the trial stimulation
proves successful, the patient may receive a fully implanted IPG
(10, FIG. 1). The patient will typically also receive an external
controller (45, FIG. 4), which may be programmed with one or more
stimulation programs comprising the parameters that have been
determined to be most effective. The external controller allows the
patient to select the stimulation programs and also allows them to
control various parameters of their therapy, such as stimulation
intensity, duration, etc. Under current paradigms, the patient is
simply released and they can self-administer therapy at will
without returning to the physician for review of effectiveness or
follow-up.
[0048] The inventors have recognized deficiencies with this
treatment paradigm. For one, simply releasing the patient without
further scheduled follow-ups may be a missed opportunity for
further evaluation and optimization of the patient's therapy. This
is in contrast to typical pharmaceutical treatment regimens in
which a clinician prescribes a finite number of doses of a drug and
requires a follow-up visit to refill the prescription.
[0049] Another problem with the present SCS treatment paradigm of
allowing the patient the unfettered ability to self-medicate is
that the patient may overuse stimulation and develop a tolerance to
their stimulation. Overstimulation can reduce the effectiveness of
therapy even in the absence of other side effects. A patient may
increase the frequency and/or intensity of their stimulation in an
effort to compensate for a decrease in the effectiveness of their
therapy. But such increases in stimulation can actually negatively
impact the patient's therapy because they accelerate the rate at
which the patient develops a tolerance to the stimulation. An ideal
system would enable a clinician to manage the use of stimulation so
that the patient does not overuse the stimulation and reduce the
therapy effectiveness.
[0050] Disclosed herein are systems and methods that enable a
clinician to prescribe a set amount of stimulation that a patient
can receive before requiring the patient to seek a further
prescription for additional stimulation. According to some
embodiments, the prescribed amount of stimulation can be programmed
into the patient's external controller or into the IPG. The system
may track the amount of stimulation used. The user interface of the
external controller may include an indication of the amount of
prescribed stimulation remaining. When the patient has used all of
the prescribed stimulation, the patient may be directed to make an
appointment for a follow-up visit with their clinician to obtain a
"refill" for their stimulation prescription. According to some
embodiments, the patient's external controller may be an internet
connectable device, in which case, the external controller may be
configured to send a message to the clinician indicating that the
patient has used all of their prescribed stimulation so that the
clinician can proactively contact the patient to arrange an
appointment.
[0051] FIG. 7 illustrates a system 700 for prescribing and
monitoring stimulation therapy. The system comprises a clinician
programmer 50, which includes the functionality described above. In
addition, the clinician programmer 50 comprises one or more therapy
prescription modules 702, which are configured to aid the clinician
in prescribing an amount of stimulation therapy. The therapy
prescription module(s) 702 may be implemented as instructions
embodied within non-transitory computer readable media associated
with the clinician programmer 50 and executable by processing
resources (i.e., one or more microprocessors and/or control
circuitry) of the clinician programmer. Such execution configures
the clinician programmer to perform the functionality of the
prescription module 702, which is described in more detail
below.
[0052] The clinician programmer is configured to transmit the
stimulation prescription to the patient's external controller 45 or
to the patient's IPG 10. The patient's external controller 45 may
have all of the functionality described above for controlling the
patient's IPG 10 (FIGS. 1, 3, and 4), ETS (FIG. 4), and/or EPS 604
(FIG. 6). In the illustrated embodiment, the external controller is
configured with a stimulation tracking and display module 704 that
is configured to receive the stimulation prescription from the
clinician programmer 50, track the amount of stimulation used, and
display an amount of stimulation remaining on the prescription to
the patient. The stimulation tracking and display module 704 may be
implemented as instructions embodied within non-transitory computer
readable media associated with the external controller 45 and
executable by processing resources (i.e., one or more
microprocessors and/or control circuitry) of the external
controller. Such execution configures the external controller to
perform the functionality of the stimulation tracking and display
module. According to other embodiments, the prescription and the
tracking of the stimulation used may be performed in the IPG, which
can communicate the prescription/use information to the patient's
external controller for display.
[0053] As the prescribed stimulation is used up, the patient may be
prompted to schedule an appointment with their clinician to receive
a further prescription for additional stimulation. As mentioned
above, if the patient's external controller 45 is an
internet-connected device, the external controller may be
configured to send a notice to the clinician indicating that the
patient's prescribed amount of stimulation is depleted or
approaching depletion so that the clinician can proactively contact
the patient to schedule an appointment. In embodiments wherein the
IPG tracks the prescription, the IPG may be configured to send a
notice to the patient's personal phone or other computing device
(via a Bluetooth connection, for example) informing them that the
prescription is depleted or nearing depletion. According to some
embodiments, the clinician programmer 50 may be configured to
refresh the prescription via an internet connection.
[0054] According to some embodiments, the prescribed amount of
stimulation can be set as a total amount of actively delivered
charge. FIG. 8 illustrates an example of an embodiment of an
algorithm 800 that a clinician may use to determine and prescribe
an amount of total charge to prescribe for a patient's therapy. The
algorithm 800 may implemented as a program in the clinician
programmer 50 (FIG. 4), for example, as a component of a
prescription module 702 (FIG. 7). The algorithm assumes that the
clinician and patient have determined one or more stimulation
programs that are expected to be beneficial for the patient. The
process of determining appropriate stimulation programs may be
referred to as a fitting process.
[0055] At step 802 of the algorithm, the algorithm receives the
stimulation parameters for the one or more programs that have been
determined during the fitting process. For example, assume that the
clinician has determined that the patient experiences pain relief
when the patient is stimulated using a simple biphasic stimulation
waveform, such as the waveform illustrated in FIG. 2. Assume that
the waveform has a frequency of 100 Hz, an amplitude of 3 mA, and a
pulse width of 100 .mu.s. All of those parameters are provided to
the algorithm at step 802. Of course, the stimulation program could
be more complex, for example, involving complex pulse shapes, pulse
patterns, and the like. Moreover, multiple programs may be
determined during the fitting process. But for simplicity, a single
simple biphasic waveform is considered here.
[0056] At step 804 the algorithm analyzes the stimulation waveforms
contained in the defined stimulation program and calculates the
rate of charge injection into the patient (i.e., the amount of
actively driven charge provided as a function of time) when
executing the stimulation program. For example, the stimulation
parameters listed above would nominatively pass 0.108 Coulombs of
charge per hour when executing the stimulation program.
[0057] At step 806 the algorithm receives input indicating an
amount of time that stimulation should ideally be applied before
the patient returns for a follow-up visit. For example, assume that
the clinician believes that the patient should generally applying
stimulation for 12 hours per day and the clinician would like for
the prescription to be adequate for six months, after which, the
patient should return for a follow-up visit. The clinician would
enter those time parameters into the user interface of the
clinician programmer, for example, as part of the prescription
module 702 (FIG. 7).
[0058] At step 808 the algorithm calculates a charge prescription.
In this simple example, the calculation is relatively straight
forward. The values of the programmed stimulation
parameters--amplitude, frequency, and pulse width--provide actively
driven charge at a rate of 0.108 Coulombs per hour. That rate
correlates to 1.3 Coulombs per day if the patient applies
stimulation for 12 hours per day, which further correlates to 232
Coulombs over six months (180 days). Thus, the prescription will be
calculated as 232 Coulombs, based on the parameters provided by the
clinician. It should be appreciated that since the algorithm has
access to the stimulation waveform program and the relevant
stimulation parameters, the algorithm can be configured to
calculate the actively driven charge for generally any duration of
stimulation, even for complex waveforms.
[0059] At step 810, the calculated charge prescription can be
transmitted from the clinician programmer to the patient's external
controller. It should be noted that while the illustrated algorithm
800 computes a stimulation prescription based on Coulombs of
charge, neither the clinician nor the patient may be interested in
the absolute value of Coulombs, per se. Instead, the clinician can
simply prescribe stimulation based on the particular stimulation
parameters, the amount of stimulation per day, and the ideal length
of time before a follow-up appointment. Given those data points,
the algorithm 800 calculates a "charge prescription." It should
also be noted that the prescription may be determined on the basis
of total energy or some other metric that relates to an amount of
stimulation. For example, the clinician may prescribe stimulation
on the basis of time, time per day, or boluses of stimulation,
which is discussed in more detail below. The prescription module
702 executed on the clinician programmer may be configured with
different options for allowing the clinician to prescribe
stimulation.
[0060] FIG. 9 illustrates an embodiment of an external controller
45 having a display 46. The external controller may comprise a
stimulation tracking and display module 704 (FIG. 7) configured to
receive the stimulation prescription from the physician controller
and to account for the amount of charge used during stimulation.
The amount of charge remaining for the patient's prescription may
be displayed on the display 46 of the patient's external
controller. For example, in the illustrated embodiment, the
external controller presents a gauge 902 indicating the amount of
therapy remaining on the prescription. As the patient uses their
SCS system their external controller can track the amount of charge
used and may display the amount of charge remaining on the
prescription (either as charge or some variable related to charge).
When the patient's prescribed charge is depleted or approaching
depletion, they may be prompted to schedule a follow-up appointment
with the clinician. The patient may use their prescribed amount of
stimulation at a faster rate than anticipated, for example, by
applying stimulation more frequently or by using a greater
amplitude or pulse width. In that case, the patient will be
prompted to schedule a follow-up sooner than the anticipated six
months. This may afford the patient and clinician to explore
reasons that the patient is requiring more stimulation than
anticipated.
[0061] According to some embodiments, stimulation may be provided
in discreet chunks of stimulation, referred to as a "bolus" of
stimulation. A bolus of stimulation may be thought of as analogous
to a single dose of stimulation, similar to a dose of a
pharmaceutical agent. For example, a bolus may comprise stimulation
for a first period of time, such as 10 minutes of stimulation (or
30 minutes, or 1 hour, etc.). After a bolus is issued further
stimulation is not provided until another bolus is issued.
Typically, the time period between boluses (i.e., a second period
of time) is on the order of at least minutes, or hours, for
example. For example, according to some embodiments, the second
period of time may be thirty minutes to twelve hours. However,
according to some embodiments, a patient could issue themselves
another bolus immediately following a first bolus, just as patient
could take a second dose of a pharmaceutical immediately following
a first dose.
[0062] It has been observed that some patients respond well to
bolus mode treatment. A patient may initiate a bolus of stimulation
when they feel pain coming on. Some patients experience extended
pain relief, up to several hours or more, following receiving a
bolus of stimulation. According to some embodiments, a clinician
may prescribe stimulation therapy based on a number of boluses of
stimulation. To draw an analogy to a pharmaceutical prescription, a
clinician might prescribe a given number of boluses of stimulation
to a patient per day for a certain duration. For example, a
clinician might prescribe five 30-minute boluses of stimulation per
day for three months, after which the patient returns to the
clinician for a follow-up evaluation.
[0063] FIG. 10 illustrates an example of a method 1000 of
determining and prescribing a bolus mode treatment. At step 1002,
appropriate stimulation parameters are determined for the patient.
This process is generally done in a fitting session with the aid of
a clinician programmer 50 (FIGS. 4, 5, and 7), as described above.
Assume that, during the fitting process, the clinician has
determined one or more stimulation programs that alleviate the
patient's pain and also assume that the clinician believes that the
patient may respond well to bolus mode treatment. Having determined
optimum stimulation parameters, the patient may be released with an
implanted IPG (or ETS or EPS) and their external controller 45 to
determine an appropriate time period corresponding to a bolus of
stimulation. For example, the stimulation tracking and display
module 704 in the patient's external controller may be programmed
with a bolus algorithm configured to help the patient and clinician
determine an appropriate bolus of stimulation. The goal is to
determine a time period of stimulation that achieves long-lasting
pain relief. When the patient experiences the onset of pain, they
may activate a trial bolus. For example, a trial bolus may comprise
5 minutes of stimulation using the patient's optimum stimulation
parameters. The patient will receive a bolus of stimulation, after
which the stimulation will terminate. The patient may then be asked
to periodically rate their pain relief (for example, every hour
after the administration of the trial bolus) using the interface of
their external controller. Over a period of days or weeks,
different time periods of stimulation may be tried to determine a
minimum time period that provides the longest-lasting pain relief.
Various optimization criteria may be used for making the
determination of an optimum bolus, depending on the patient's and
the clinician's preferences. Alternatively, the clinician may
simply decide what time period of stimulation will constitute a
bolus of stimulation at step 1004.
[0064] Having determined an appropriate stimulation duration
corresponding to a bolus of stimulation, the patient may receive a
prescription for a number of boluses (step 1006). According to some
embodiments, the patient may return to their clinician following
the bolus determination step (step 1004) so that the clinician can
program the patient's external controller with a prescription for a
given number of boluses. According to some embodiments, if the
patient's external controller is an internet-connected device, the
patient may not need to return to the clinician. Instead, the
patient's external controller may transmit the bolus duration to
the clinician programmer via an internet connection and the
clinician programmer may transmit the bolus prescription to the
patient's external controller via the internet connection. Once the
patient's external controller is programmed with a bolus
prescription, the external controller can monitor the number of
boluses used (Step 1008). The number of boluses remaining on the
patient's prescription may be displayed on the external controller.
Once the patient has used the prescribed number of boluses, the
patient may be prompted to schedule a follow-up visit with the
clinician.
[0065] It should be noted that, according to some embodiments, the
clinician may simply prescribe a certain stimulation duration as a
bolus without using an algorithm such as the algorithm 1000. For
example, the clinician may simply decide that a bolus of
stimulation will correspond to ten minutes of stimulation.
Alternatively, according to some embodiments, the patient's
external controller may be programmed with an algorithm that helps
the patient determine an appropriate bolus of stimulation without
approval of the clinician. For example, the patient's external
controller may be programmed with a bolus calibration duration, for
example, two weeks, during which the patient is prompted to rank
therapy using different bolus durations. After the calibration
duration, the external controller considers the determined optimum
duration of stimulation as a bolus of stimulation. The external
controller may then begin tracking the number of boluses remaining
for the patient's prescription. For example, the GUI of the
external controller may inform the patient that they have x of y
boluses remaining.
[0066] According to some embodiments, the patient's external
controller may be programmed with one or more algorithms that
attempt to optimize when a bolus of stimulation should issue. When
the algorithm determines that a bolus should be issued, the
patient's external controller may alert the patient to administer
themselves a bolus of stimulation. Such an embodiment may be
particularly useful for patients using an RF system (i.e., a system
without an implanted IPG). A patient using such a system can
receive a notice or alert when it is time to receive a bolus of
stimulation and the patient can then arrange their external power
supply (EPS) appropriately an administer themselves a bolus.
Alternatively, a patient using a system with a traditional IPG can
use their external controller to cause the IPG to issue a bolus of
stimulation when they receive an alert that it is time to issue a
bolus. According to some embodiments, the external controller may
simply instruct the IPG to issue a bolus automatically without the
patient instructing the external controller to so. According to
some embodiments, the patient may receive an alert on their
personal computing device, such as a personal phone, that it is
time to take a bolus.
[0067] FIG. 11 illustrates an example of an algorithm 1100 for
predicting when a bolus should issue. The algorithm 1100 comprises
a "training period" during which the algorithm attempts to
correlate one or more "pain predictors" with instances that the
patient issues themselves a bolus. The pain predictor is a
predictor indicative of a need for stimulation. Examples of pain
predictors may include the time of day, the weather, the patient's
activity level, or one or more physiological parameters of the
patient, such as heartrate, blood pressure, posture, or the like.
For example, during the training period the algorithm may determine
that the patient tends to issue themselves a bolus at certain times
during the day. The algorithm may therefore determine that those
are the times of day that the patient tends to experience pain.
Likewise, the algorithm may determine that the patient tends to
administer a bolus when they transition from sitting to standing,
or vice-versa. Such postural changes may be detected using measured
evoked compound action potentials (ECAPs) or other sensed neural
responses, as described in Provisional Patent Application No.
62/860,627, filed Jan. 22, 2019, Attorney Docket No. 585-0308PUS.
Alternatively (or additionally), postural changes and/or patient
activity level may be determined using accelerometers.
Physiological parameters, such as heartrate, blood pressure, and
the like may be determined using one or more physiological sensors
associated with the patient. According to some embodiments, pain
predictors such as activity level, weather, posture, and the like,
may be determined based on patient input, for example, via an
application running on their external controller or other external
device in communication with their external controller.
Alternatively, to determine weather conditions, the patient's
external controller (or other external device in communication with
the external controller) may be configured to obtain weather
information via internet weather data. The training period may be a
few days or a few weeks, for example.
[0068] Once the training period is concluded, the algorithm may
proceed to a directed therapy or automatic therapy regime wherein
the algorithm monitors for one or more of the pain predictors. When
a pain predictor is detected the algorithm may either instruct the
patient to preemptively issue themselves a bolus or may
automatically issue the patient a bolus without patient input. As
mentioned above, embodiments wherein the patient is instructed to
issue themselves a bolus are particularly useful for patients with
an RF system that does not use an implanted IPG.
[0069] According to some embodiments, the patient may be prompted
for feedback ranking the effectiveness of the attempted therapy
programs, for example, by selecting a ranking on the user interface
of their external controller. Based on the patient feedback, the
algorithm may attempt to optimize the algorithm.
[0070] FIGS. 12A-12C illustrate an example of the algorithm 1100
for determining when to preemptively issue a bolus of stimulation.
The example algorithm 1100 illustrated in FIG. 12A-12C uses the
time of day as the pain predictor and also uses patient feedback to
optimize the algorithm. FIG. 12A illustrates a training period
where the patient self-administers a bolus (represented by a
capsule in FIGS. 12A-12C) each time they perceive the onset of pain
(represented by a lighting bolt). According to some embodiments, an
algorithm may track the times that the patient issues themselves a
bolus and then attempt to preemptively issue a bolus before the
patient experiences pain onset. Notice in FIG. 12A that the
patient's pain onset events are weighted more heavily to the early
part of the day. Assume that the algorithm 1100 has tracked the
three days of therapy illustrated in FIG. 12A. FIG. 12B illustrates
an attempt by the algorithm to preemptively issue boluses of
therapy over a three-day period based on the boluses that the
patient administered in FIG. 12A. For example, in FIG. 12A, the
patient, on average, administered three boluses per day. So, in
FIG. 12B, the algorithm 1100 automatically provides those boluses
each day at time periods that best match those in FIG. 12A. The
patient can continue to self-administer boluses and the algorithm
1100 can continue to optimize the timing of automatically providing
boluses. For example, on days one and three, the preemptively
issued boluses of were not sufficient to completely curtail the
patient's pain and the patient had to self-administer an extra
bolus on those days. In FIG. 12B, the patient has rated the therapy
two-out-of-five. In FIG. 12C, the algorithm has attempted to
improve the therapy by issuing the third bolus earlier in the day,
corresponding to the self-administered boluses. The patient has not
had to self-administer a bolus of stimulation over a three-day
period and has ranked the therapy a four-out-of-five. The algorithm
1100 may thus determine that the timing determined in FIG. 10C may
be used as ongoing therapy.
[0071] Bolus mode therapy may provide several advantages compared
to traditional continuous therapy. For example, bolus mode therapy
may decrease the chances that the patient overuses stimulation,
thereby developing a tolerance to the therapy. Also, bolus mode
therapy is particularly well suited for RF stimulation systems,
such as described above with reference to FIG. 6. Since a bolus of
stimulation is only applied for a finite duration of time, a
patient using an RF system need only have access to their external
power supply during the time they are receiving a bolus of
stimulation.
[0072] Various aspects of the disclosed techniques, including
processes implementable in the IPG or ETS, or in external devices
such as the clinician programmer and/or the external controller can
be formulated and stored as instructions in a computer-readable
media associated with such devices, such as in a magnetic, optical,
or solid-state memory. The computer-readable media with such stored
instructions may also comprise a device readable by the clinician
programmer or external controller, such as in a memory stick or a
removable disk, and may reside elsewhere. For example, the
computer-readable media may be associated with a server or any
other computer device, thus allowing instructions to be downloaded
to the clinician programmer system or external controller or to the
IPG or ETS, via the Internet for example. The various algorithms
described herein and stored in non-transitory computer readable
media can be executed by one or more microprocessors and/or control
circuitry configured within the relevant device, thereby causing
the device to perform the steps of the algorithm(s).
[0073] Note that some of the applications to which this present
disclosure claim priority, which are incorporated by reference
above, are directed to concepts (e.g., picking optimal stimulation
parameters, and in particular stimulation parameters that cause
sub-perception at lower frequencies) that are relevant to what is
disclosed. Techniques in the present disclosure can also be used in
the context of these priority applications. For example, the
prescribed stimulation may be determined and optimized using the
techniques described in some of the priority applications. Also,
the parameters of the bolus stimulation may be determined and
optimized using the techniques described in some of the priority
applications.
[0074] Although particular embodiments of the present invention
have been shown and described, it should be understood that the
above discussion is not intended to limit the present invention to
these embodiments. It will be obvious to those skilled in the art
that various changes and modifications may be made without
departing from the spirit and scope of the present invention. Thus,
the present invention is intended to cover alternatives,
modifications, and equivalents that may fall within the spirit and
scope of the present invention as defined by the claims.
* * * * *