U.S. patent application number 15/912058 was filed with the patent office on 2018-07-19 for non-invasive nerve stimulation.
The applicant listed for this patent is Neurostim OAB, Inc.. Invention is credited to Graham Harold CREASEY, MICHAEL BERNARD DRUKE, Alan E. LOH, Robert W. SCOTT, Hoo-min D. TOONG, Anthony WEI.
Application Number | 20180200514 15/912058 |
Document ID | / |
Family ID | 62838928 |
Filed Date | 2018-07-19 |
United States Patent
Application |
20180200514 |
Kind Code |
A1 |
DRUKE; MICHAEL BERNARD ; et
al. |
July 19, 2018 |
NON-INVASIVE NERVE STIMULATION
Abstract
A topical nerve stimulator patch and system are provided
including a dermal patch; an electrical signal generator associated
with the patch; a signal receiver to activate the electrical signal
generator; a power source for the electrical signal generator
associated with the patch; an electrical signal activation device;
and a nerve feedback sensor.
Inventors: |
DRUKE; MICHAEL BERNARD;
(Half Moon Bay, CA) ; LOH; Alan E.; (Los Altos,
CA) ; SCOTT; Robert W.; (El Grenada, CA) ;
WEI; Anthony; (Palo Alto, CA) ; CREASEY; Graham
Harold; (Menlo Park, CA) ; TOONG; Hoo-min D.;
(Cambridge, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Neurostim OAB, Inc. |
Waltham |
MA |
US |
|
|
Family ID: |
62838928 |
Appl. No.: |
15/912058 |
Filed: |
March 5, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15040856 |
Feb 10, 2016 |
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15912058 |
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|
14893946 |
Nov 25, 2015 |
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PCT/US2014/040240 |
May 30, 2014 |
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15040856 |
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62582634 |
Nov 7, 2017 |
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62574625 |
Oct 19, 2017 |
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62115607 |
Feb 12, 2015 |
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61828981 |
May 30, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/0402 20130101;
A61B 5/0022 20130101; A61N 1/3603 20170801; A61B 5/6829 20130101;
A61B 2562/029 20130101; A61N 1/0452 20130101; A61N 1/36007
20130101; A61B 2562/063 20130101; A61B 5/11 20130101; A61B 5/0036
20180801; A61B 5/6832 20130101; A61B 2562/0247 20130101; A61B 5/01
20130101; A61N 1/0492 20130101; A61B 5/04001 20130101; A61B 5/0488
20130101; A61B 5/1495 20130101; A61B 5/0531 20130101; A61N 1/36021
20130101; A61N 1/0476 20130101; A61N 1/0456 20130101; A61B 5/4836
20130101; A61B 5/6807 20130101; A61B 2562/164 20130101; A61B 5/6825
20130101; A61B 5/4824 20130101 |
International
Class: |
A61N 1/36 20060101
A61N001/36; A61N 1/04 20060101 A61N001/04 |
Claims
1. A topical nerve stimulation patch comprising: a flexible
substrate; a malleable dermis conforming bottom surface of the
substrate comprising adhesive and adapted to contact the dermis; a
flexible top outer surface of the substrate approximately parallel
to the bottom surface; a plurality of electrodes positioned on the
patch proximal to the bottom surface and located beneath the top
outer surface and coupled to the flexible substrate; and electronic
circuitry embedded in the patch and located beneath the top outer
surface and coupled to the flexible substrate, the electronic
circuitry comprising: an electrical signal generator integral to
the malleable dermis conforming bottom surface configured to
electrically activate the electrodes; an antenna in communication
with the electrical signal generator; a signal activator coupled to
the electrical signal generator; and a power source in electrical
communication with the electrical signal generator, the antenna and
the signal activator.
2. The topical nerve stimulation patch of claim 1, further
comprising: a nerve stimulation sensor that provides feedback in
response to a stimulation of one or more nerves and is coupled to
the flexible substrate.
3. The topical nerve stimulation patch of claim 2, the antenna
configured to communicate with a remote activation device; the
signal activator configured to activate in response to receipt of a
communication with the activation device by the antenna; the
electrical signal generator configured to generate one or more
electrical stimuli in response to activation by the signal
activator; the electrical stimuli configured to stimulate one or
more nerves of a user wearing the nerve stimulation patch at least
at one location proximate to the patch.
4. The topical nerve stimulation patch of claim 2 that when coupled
to a user is configured to generate a treatment comprising:
determining a target charge level; outputting a series of pulses
from the electrodes; for each pulse outputted, measuring a charge
value of the pulse and compare the charge value to the target
charge level; if the charge value is greater than the target charge
level, reducing a strength level of a subsequent outputted pulse;
and if the charge value is less than the target charge level,
increasing the strength level of a subsequent outputted pulse.
5. The topical nerve stimulation patch of claim 4, in which the
series of pulses are defined based on a frequency and duration.
6. The topical nerve stimulation patch of claim 4, in which
determining the target charge level Q.sub.target comprises
generating an acquisition series of pulses and Q target = i = 1 T *
f Q pulse ( i ) , ##EQU00002## where T is a duration of the
acquisition series of pulses, f is a frequency of the acquisition
series of pulses and Q.sub.pulse(i) is a measured charge of each of
the acquisition series of pulses.
7. The topical nerve stimulation patch of claim 4, the electronic
circuitry further comprising a differential integrator, the charge
value of the pulse based on an output of the differential
integrator.
8. The topical nerve stimulation patch of claim 3, further
comprising a shape that is based on the location and causes the
electrodes to generally be arranged along an axis of the nerves to
be stimulated.
9. A method of using a topical nerve stimulation system patch for
electrical stimulation, the method comprising: applying the patch
to a dermis using adhesive, the patch comprising: a flexible
substrate; a malleable dermis conforming bottom surface of the
substrate comprising adhesive and adapted to contact the dermis; a
flexible top outer surface of the substrate approximately parallel
to the bottom surface; a plurality of electrodes positioned on the
patch proximal to the bottom surface and located beneath the top
outer surface and coupled to the flexible substrate; and electronic
circuitry embedded in the patch and located beneath the top outer
surface and coupled to the flexible substrate, the electronic
circuitry comprising: an electrical signal generator integral to
the malleable dermis conforming bottom surface configured to
electrically activate the electrodes; an antenna in communication
with the electrical signal generator; a signal activator coupled to
the electrical signal generator; and a power source in electrical
communication with the electrical signal generator, the antenna and
the signal activator; generating one or more electrical stimuli in
response to activation by the signal activator; and receiving
feedback from the electrical stimuli.
10. The method of claim 9, the feedback provided by a nerve
stimulation sensor that provides the feedback in response to a
stimulation of one or more nerves and is coupled to the flexible
substrate.
11. The method of claim 10, the antenna configured to communicate
with a remote activation device; the signal activator configured to
activate in response to receipt of a communication with the
activation device by the antenna; and the electrical signal
generator configured to generate one or more electrical stimuli in
response to activation by the signal activator.
12. The method of claim 9, further comprising: determining a target
charge level; outputting a series of pulses from the electrodes;
for each pulse outputted, measuring a charge value of the pulse and
compare the charge value to the target charge level; if the charge
value is greater than the target charge level, reducing a strength
level of a subsequent outputted pulse; and if the charge value is
less than the target charge level, increasing the strength level of
a subsequent outputted pulse.
13. The method of claim 12, in which the series of pulses are
defined based on a frequency and a duration.
14. The method of claim 12, in which determining the target charge
level Q.sub.target comprises generating an acquisition series of
pulses and Q target = i = 1 T * f Q pulse ( i ) , ##EQU00003##
where T is duration of the acquisition series of pulses, f is a
frequency of the acquisition series of pulses and Q.sub.pulse (i)
is a measured charge of each of the acquisition series of
pulses.
15. The method of claim 12, the electronic circuitry further
comprising a differential integrator, the charge value of the pulse
based on an output of the differential integrator.
16. A topical nerve stimulation patch comprising: a flexible
substrate; a malleable dermis conforming bottom surface of the
substrate comprising adhesive and adapted to contact the dermis; a
flexible top outer surface of the substrate approximately parallel
to the bottom surface; a plurality of electrodes positioned on the
patch proximal to the bottom surface and located beneath the top
outer surface and coupled to the flexible substrate; and a
processor coupled to the flexible substrate and a storage device
that stores instructions, the processor, when executing the
instructions: determining a target charge level; outputting a
series of pulses from the electrodes; for each pulse outputted,
measuring a charge value of the pulse and compare the charge value
to the target charge level; if the charge value is greater than the
target charge level, reducing a strength level of a subsequent
outputted pulse; and if the charge value is less than the target
charge level, increasing the strength level of a subsequent
outputted pulse.
17. The patch of claim 16, in which the series of pulses are
defined based on a frequency and duration.
18. The patch of claim 16, in which determining the target charge
level Q.sub.target comprises generating an acquisition series of
pulses and Q target = i = 1 T * f Q pulse ( i ) , ##EQU00004##
where T is duration of the acquisition series of pulses, f is a
frequency of the acquisition series of pulses and Q.sub.pulse (i)
is a measured charge of each of the acquisition series of
pulses.
19. The patch of claim 16, further comprising a differential
integrator, the charge value of the pulse based on an output of the
differential integrator.
20. The patch of claim 16 having a shape that is based on a
location on the dermis and causes the electrodes to generally be
arranged along an axis of the nerves to be stimulated.
21. A topical nerve stimulation patch for treatment of overactive
bladder, comprising: a flexible substrate comprising a dermis
conforming bottom surface and a flexible top outer surface; an
adhesive for topically attaching the patch to tissue; a plurality
of electrodes positioned on the patch on the bottom surface of the
substrate and located beneath the top outer surface; electronic
circuitry embedded within the patch and located beneath the top
outer surface of the substrate, comprising: an electrical signal
generator providing a train of voltage regulated waves across the
electrodes to generate an electric current that stimulates a nerve
to inhibit a user's sensation of needing to urgently empty the
user's bladder; an antenna for communicating with a remote device
and receiving a signal therefrom to activate the signal generator;
and a power source in electrical communication with the signal
generator.
22. The patch of claim 21, the electrodes adapted to generate a
current between about 20 mA and 100 mA during use.
23. The patch of claim 22, the voltage regulated waves comprising
square waves.
24. The patch of claim 23, the squares waves comprising a frequency
between approximately 15 Hz and 50 Hz.
25. The patch of claim 21, the remote device comprising a FOB and
depressing a button on the FOB activates the signal generator of
the patch.
26. The patch of claim 21, the remote device comprising a
smartphone or tablet comprising software configured to allow a user
to communicate, using the smartphone or tablet, with the antenna of
the patch and activate the signal generator.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority of U.S. Provisional Patent
Application Ser. No. 62/582,634, filed on Nov. 7, 2017, claims
priority of U.S. Provisional Patent Application Ser. No.
62/574,625, filed on Oct. 19, 2017, and claims priority as a
continuation-in-part application of U.S. patent application Ser.
No. 15/040,856, filed on Feb. 10, 2016, which claims priority to
U.S. Provisional Patent Application Ser. No. 62/115,607, filed Feb.
12, 2015 and claims priority as a continuation-in-part application
of U.S. patent application Ser. No. 14/893,946, filed on Nov. 25,
2015, which claims priority to PCT Patent Application Serial No.
PCT/US14/40240, filed May 30, 2014, which claims priority to U.S.
Provisional Patent Application Ser. No. 61/828,981, filed May 30,
2013. The disclosure of each of these applications is hereby
incorporated by reference.
FIELD
[0002] This invention pertains to the activation of nerves by
topical stimulators to control or influence muscles, tissues,
organs, or sensation, including pain, in humans and mammals.
BACKGROUND INFORMATION
[0003] Nerve disorders may result in loss of control of muscle and
other body functions, loss of sensation, or pain. Surgical
procedures and medications sometimes treat these disorders but have
limitations. This invention pertains to a system for offering other
options for treatment and improvement of function.
BRIEF DESCRIPTION OF THE DRAWINGS
[0004] FIG. 1 is a depiction of a neuron activating a muscle by
electrical impulse.
[0005] FIG. 2 is a representation of the electrical potential
activation time of an electrical impulse in a nerve.
[0006] FIG. 3 is a cross section of a penis.
[0007] FIG. 4 is an illustration of a Topical Nerve
Stimulator/Sensor (TNSS) component configuration including a system
on a chip (SOC).
[0008] FIG. 5 is an illustration of the upper side of a Smart Band
Aid implementation of a TNSS showing location of battery, which may
be of various types.
[0009] FIG. 6 is an illustration of the lower side of the SBA of
FIG. 5.
[0010] FIG. 7 is TNSS components incorporated into a SBA.
[0011] FIG. 8 is examples of optional neural stimulator and sensor
chip sets incorporated into a SBA.
[0012] FIG. 9 is examples of optional electrode configurations for
a SBA.
[0013] FIG. 10 is an example of the use of TNSS with a Control Unit
as a System, in a population of Systems and software
applications.
[0014] FIG. 11 shows a method for forming and steering a beam by
the user of a plurality of radiators.
[0015] FIG. 12 is an exemplary beam forming and steering
mechanism.
[0016] FIG. 13 illustrates exemplary Control Units for activating a
nerve stimulation device.
[0017] FIG. 14 are exemplary software platforms for communicating
between the Control Units and the TNSS, gathering data, networking
with other TNSSs, and external communications.
[0018] FIG. 15 represents TNSS applications for patients with
spinal cord injury.
[0019] FIG. 16 shows an example TNSS system.
[0020] FIG. 17 shows communications among the components of the
TNSS system of FIG. 16 and a user.
[0021] FIG. 18 shows an example electrode configuration for
electric field steering and sensing.
[0022] FIG. 19 shows an example of stimulating and sensing patterns
of signals in a volume of tissue.
[0023] FIG. 20 is a graph showing pulses applied to the skin.
[0024] FIG. 21 is a graph showing symmetrical and asymmetrical
pulses applied to the skin.
[0025] FIG. 22 is a cross-sectional diagram showing a field in
underlying tissue produced by application of two electrodes to the
skin.
[0026] FIG. 23 is a cross-sectional diagram showing a field in
underlying tissue produced by application of two electrodes to the
skin, with two layers of tissue of different electrical
resistivity.
[0027] FIG. 24 is a cross-sectional diagram showing a field in
underlying tissue when the stimulating pulse is turned off.
[0028] FIG. 25A is a system diagram of an example software and
hardware components showing an example of a Topical Nerve
Stimulator/Sensor (TNSS) interpreting a data stream from a control
device in accordance with one example.
[0029] FIG. 25B is a flow chart showing an example of a function of
a master control program in accordance with one example.
[0030] FIG. 26 is a block diagram of an example TNSS component
configuration including a system on a chip (SOC) in accordance with
one example.
[0031] FIG. 27 is a flow diagram of the protocol for adaptive
current control in accordance with one example.
[0032] FIG. 28 is a Differential Integrator Circuit used in the
Adaptive Current Protocol in accordance with one example.
[0033] FIG. 29 is a table relating charge duration vs. frequency to
provide feedback to the Adaptive Current Protocol in accordance
with one example.
[0034] FIG. 30 is a tibial patch or TNSS or SmartPad designed in a
shape to conform to the skin in accordance with one example.
[0035] FIG. 31 is a tibial patch or TNSS or SmartPad designed in a
shape to conform to the skin in accordance with other examples.
[0036] FIG. 32 is a skin patch that includes a SmartPad with TNSS
design and packaging in accordance with one example.
[0037] FIG. 33 illustrates other example locations for a patch.
[0038] FIG. 34 illustrates a cutaway view where a right foot
plantar sock patch is affixed into the sole of a sock in accordance
with one example.
[0039] FIG. 35 illustrates a cutaway view where a right foot
plantar shoe patch is affixed into the sole of a shoe in accordance
with one example
DETAILED DESCRIPTION
[0040] A method for electrical, mechanical, chemical and/or optical
interaction with a human or mammal nervous system to stimulate
and/or record body functions using small electronic devices
attached to the skin and capable of being wirelessly linked to and
controlled by a cellphone, activator or computer network.
[0041] The body is controlled by a chemical system and a nervous
system. Nerves and muscles produce and respond to electrical
voltages and currents. Electrical stimulation of these tissues can
restore movement or feeling when these have been lost, or can
modify the behavior of the nervous system, a process known as neuro
modulation. Recording of the electrical activity of nerves and
muscles is widely used for diagnosis, as in the electrocardiogram,
electromyogram, electroencephalogram, etc. Electrical stimulation
and recording require electrical interfaces for input and output of
information. Electrical interfaces between tissues and electronic
systems are usually one of three types:
[0042] a. Devices implanted surgically into the body, such as
pacemakers. These are being developed for a variety of functions,
such as restoring movement to paralyzed muscles or restoring
hearing, and can potentially be applied to any nerve or muscle.
These are typically specialized and somewhat expensive devices.
[0043] b. Devices inserted temporarily into the tissues, such as
needles or catheters, connected to other equipment outside the
body. Health care practitioners use these devices for diagnosis or
short-term treatment.
[0044] c. Devices that record voltage from the surface of the skin
for diagnosis and data collection, or apply electrical stimuli to
the surface of the skin using adhesive patches connected to a
stimulator. Portable battery-powered stimulators have typically
been simple devices operated by a patient, for example for pain
relief. Their use has been limited by;
[0045] i. The inconvenience of chronically managing wires, patches
and stimulator, particularly if there are interfaces to more than
one site, and
[0046] ii. The difficulty for patients to control a variety of
stimulus parameters such as amplitude, frequency, pulse width, duty
cycle, etc.
[0047] Nerves can also be stimulated mechanically to produce
sensation or provoke or alter reflexes; this is the basis of touch
sensation and tactile feedback. Nerves can also be affected
chemically by medications delivered locally or systemically and
sometimes targeted to particular nerves on the basis of location or
chemical type. Nerves can also be stimulated or inhibited optically
if they have had genes inserted to make them light sensitive like
some of the nerves in the eye. The actions of nerves also produce
electrical, mechanical and chemical changes that can be sensed.
[0048] The topical nerve stimulator/sensor (TNSS) is a device to
stimulate nerves and sense the actions of the body that can be
placed on the skin of a human or mammal to act on and respond to a
nerve, muscle or tissue. One implementation of the TNSS is the
Smart Band Aid.TM. (SBA). A system, incorporating a SBA, controls
neuro modulation and neuro stimulation activities. It consists of
one or more controllers or Control Units, one or more TNSS modules,
software that resides in Control Units and TNSS modules, wireless
communication between these components, and a data managing
platform. The controller hosts software that will control the
functions of the TNSS. The controller takes inputs from the TNSS of
data or image data for analysis by said software. The controller
provides a physical user interface for display to and recording
from the user, such as activating or disabling the TNSS, logging of
data and usage statistics, generating reporting data. Finally, the
controller provides communications with other Controllers or the
Internet cloud.
[0049] The controller communicates with the Neurostim module, also
called TNSS module or SBA, and also communicates with the user. In
at least one example, both of these communications can go in both
directions, so each set of communications is a control loop.
Optionally, there may also be a control loop directly between the
TNSS module and the body. So the system optionally may be a
hierarchical control system with at least four control loops. One
loop is between the TNSS and the body; another loop is between the
TNSS and the controller, another loop is between the controller and
the user, and another loop is between the controller and other
users via the cloud. Each control loop has several functions
including: (1) sending activation or disablement signals between
the controller and the TNSS via a local network such as Bluetooth;
(2) driving the user interface, as when the controller receives
commands from the user and provides visual, auditory or tactile
feedback to the user; (3) analyzing TNSS data, as well as other
feedback data such as from the user, within the TNSS, and/or the
controller and/or or the cloud: (4) making decisions about the
appropriate treatment; (5) system diagnostics for operational
correctness; and (6) communications with other controllers or users
via the Internet cloud for data transmission or exchange, or to
interact with apps residing in the Internet cloud.
[0050] The control loop is closed. This is as a result of having
both stimulating and sensing. The sensing provides information
about the effects of stimulation, allowing the stimulation to be
adjusted to a desired level or improved automatically.
[0051] Typically, stimulation will be applied. Sensing will be used
to measure the effects of stimulation. The measurements sensed will
be used to specify the next stimulation. This process can be
repeated indefinitely with various durations of each part. For
example: rapid cycling through the process (a-b-c-a-b-c-a-b-c);
prolonged stimulation, occasional sensing
(aaaa-b-c-aaaa-b-c-aaaa-b-c); or prolonged sensing, occasional
stimulation (a-bbbb-c-a-bbbb-c-a-bbbb). The process may also start
with sensing, and when an event in the body is detected this
information is used to specify stimulation to treat or correct the
event, for example, (bbbbbbbbb-c-a-bbbbbbbb-c-a-bbbbbbbbb). Other
patterns are possible and contemplated within the scope of the
application.
[0052] The same components can be used for stimulating and sensing
alternately, by switching their connection between the stimulating
circuits and the sensing circuits. The switching can be done by
standard electronic components. In the case of electrical
stimulating and sensing, the same electrodes can be used for both.
An electronic switch is used to connect stimulating circuits to the
electrodes and electric stimulation is applied to the tissues. Then
the electronic switch disconnects the stimulating circuits from the
electrodes and connects the sensing circuits to the electrodes and
electrical signals from the tissues are recorded.
[0053] In the case of acoustic stimulating and sensing, the same
ultrasonic transducers can be used for both (as in ultrasound
imaging or radar). An electronic switch is used to connect circuits
to the transducers to send acoustic signals (sound waves) into the
tissues. Then the electronic switch disconnects these circuits from
the transducers and connects other circuits to the transducers (to
listen for reflected sound waves) and these acoustic signals from
the tissues are recorded.
[0054] Other modalities of stimulation and sensing may be used
(e.g. light, magnetic fields, etc.) The closed loop control may be
implemented autonomously by an individual TNSS or by multiple TNSS
modules operating in a system such as that shown below in FIG. 16.
Sensing might be carried out by some TNSSs and stimulation by
others.
[0055] Stimulators are protocol controlled initiators of electrical
stimulation, where such protocol may reside in either the TNSS
and/or the controller and/or the cloud. Stimulators interact with
associated sensors or activators, such as electrodes or MEMS
devices.
[0056] The protocol, which may be located in the TNSS, the
controller or the cloud, has several functions including:
[0057] (1) Sending activation or disablement signals between the
controller and the TNSS via a local network such as Bluetooth. The
protocol sends a signal by Bluetooth radio waves from the
smartphone to the TNSS module on the skin, telling it to start or
stop stimulating or sensing. Other wireless communication types are
possible.
[0058] (2) Driving the user interface, as when the controller
receives commands from the user and provides visual, auditory or
tactile feedback to the user. The protocol receives a command from
the user when the user touches an icon on the smartphone screen,
and provides feedback to the user by displaying information on the
smartphone screen, or causing the smartphone to beep or buzz.
[0059] (3) Analyzing TNSS data, as well as other feedback data such
as from the user, within the TNSS, and/or the controller and/or or
the cloud. The protocol analyzes data sensed by the TNSS, such as
the position of a muscle, and data from the user such as the user's
desires as expressed when the user touches an icon on the
smartphone; this analysis can be done in the TNSS, in the
smartphone, and/or in the cloud.
[0060] (4) Making decisions about the appropriate treatment. The
protocol uses the data it analyzes to decide what stimulation to
apply.
[0061] (5) System diagnostics for operational correctness. The
protocol checks that the TNSS system is operating correctly.
[0062] (6) Communications with other controllers or users via the
Internet cloud for data transmission or exchange, or to interact
with apps residing in the Internet cloud. The protocol communicates
with other smartphones or people via the internet wirelessly; this
may include sending data over the internet, or using computer
programs that are operating elsewhere on the internet.
[0063] A neurological control system, method and apparatus are
configured in an ecosystem or modular platform that uses
potentially disposable topical devices to provide interfaces
between electronic computing systems and neural systems. These
interfaces may be direct electrical connections via electrodes or
may be indirect via transducers (sensors and actuators). It may
have the following elements in various configurations: electrodes
for sensing or activating electrical events in the body; actuators
of various modalities; sensors of various modalities; wireless
networking; and protocol applications, e.g. for data processing,
recording, control systems. These components are integrated within
the disposable topical device. This integration allows the topical
device to function autonomously. It also allows the topical device
along with a remote control unit (communicating wirelessly via an
antenna, transmitter and receiver) to function autonomously.
[0064] Referring to FIG. 1, nerve cells are normally electrically
polarized with the interior of the nerve being at an electric
potential 70 mV negative relative to the exterior of the cell.
Application of a suitable electric voltage to a nerve cell (raising
the resting potential of the cell from -70 mV to above the firing
threshold of -55 mV) can initiate a sequence of events in which
this polarization is temporarily reversed in one region of the cell
membrane and the change in polarization spreads along the length of
the cell to influence other cells at a distance, e.g. to
communicate with other nerve cells or to cause or prevent muscle
contraction.
[0065] Referring to FIG. 2, a nerve impulse is graphically
represented from a point of stimulation resulting in a wave of
depolarization followed by a repolarization that travels along the
membrane of a neuron during the measured period. This spreading
action potential is a nerve impulse. It is this phenomenon that
allows for external electrical nerve stimulation.
[0066] Referring to FIG. 3, the dorsal genital nerve on the back of
the penis or clitoris just under the skin is a purely sensory nerve
that is involved in normal inhibition of the activity of the
bladder during sexual activity, and electrical stimulation of this
nerve has been shown to reduce the symptoms of the Over Active
Bladder. Stimulation of the underside of the penis may cause sexual
arousal, erection, ejaculation and orgasm.
[0067] A Topical nerve stimulator/sensor (TNSS) is used to
stimulate these nerves and is convenient, unobtrusive,
self-powered, controlled from a smartphone or other control device.
This has the advantage of being non-invasive, controlled by
consumers themselves, and potentially distributed over the counter
without a prescription.
[0068] Referring to FIG. 4, the TNSS has one or more electronic
circuits or chips that perform the functions of: communications
with the controller, nerve stimulation via electrodes 408 that
produce a wide range of electric field(s) according to treatment
regimen, one or more antennae 410 that may also serve as electrodes
and communication pathways, and a wide range of sensors 406 such
as, but not limited to, mechanical motion and pressure,
temperature, humidity, chemical and positioning sensors. One
arrangement would be to integrate a wide variety of these functions
into an SOC, system on chip 400. Within this is shown a control
unit 402 for data processing, communications and storage and one or
more stimulators 404 and sensors 406 that are connected to
electrodes 408. An antenna 410 is incorporated for external
communications by the control unit. Also present is an internal
power supply 412, which may be, for example, a battery. An external
power supply is another variation of the chip configuration. It may
be necessary to include more than one chip to accommodate a wide
range of voltages for data processing and stimulation. Electronic
circuits and chips will communicate with each other via conductive
tracks within the device capable of transferring data and/or
power.
[0069] In one or more examples, a Smart Band Aid.TM. incorporating
a battery and electronic circuit and electrodes in the form of
adhesive conductive pads may be applied to the skin, and electrical
stimuli is passed from the adhesive pads into the tissues. Stimuli
may typically be trains of voltage-regulated square waves at
frequencies between 15 and 50 Hz with currents between 20 and 100
mA. The trains of stimuli are controlled from a smartphone operated
by the user. Stimuli may be either initiated by the user when
desired, or programmed according to a timed schedule, or initiated
in response to an event detected by a sensor on the Smart Band
Aid.TM. or elsewhere. Another implementation for males may be a
TNSS incorporated in a ring that locates a stimulator conductively
to selected nerves in a penis to be stimulated.
[0070] Referring to FIG. 5, limited lifetime battery sources will
be employed as internal power supply 412, to power the TNSS
deployed in this illustration as a Smart Band Aid.TM.. These may
take the form of Lithium Ion technology or traditional non-toxic
Mn02 technologies. FIG. 5 illustrates different battery options
such as a printable Manganese Oxide battery 516 and a button
battery 518. A TNSS of different shapes may require different
battery packaging.
[0071] FIG. 6 shows an alternate arrangement of these components
where the batteries 616-618 are positioned on the bottom side of
the SBA between the electrodes 610 and 620. In this example,
battery 616 is a lithium ion battery, battery 617 is a Mn02 battery
and battery 618 is a button battery. Other types of batteries and
other battery configurations are possible within the scope of this
application in other examples.
[0072] Aside from the Controller, the Smart Band Aid.TM. Packaging
Platform consists of an assembly of an adhesive patch capable of
being applied to the skin and containing the TNSS Electronics,
protocol, and power described above.
[0073] Referring to FIG. 7 is a TNSS deployed as a Smart Band
Aid.TM. 414. The Smart Band Aid.TM. has a substrate with adhesive
on a side for adherence to skin, the SOC 400 previously described
in FIG. 4, or electronic package, and electrodes 408 disposed
between the dermis and the adhesive surface. The electrodes provide
electrical stimuli through the dermis to nerves and other tissue
and in turn may collect electrical signals from the body, such as
the electrical signals produced by muscles when they contract (the
electromyogram) to provide data about body functions such as muscle
actions.
[0074] Referring to FIG. 8, different chips may be employed to
design requirements. Shown are sample chips for packaging in a TNSS
in this instance deployed as a SBA. For example, neural stimulator
800, sensor 802, processor/communications 804 are represented. The
chips can be packaged separately on a substrate, including a
flexible material, or as a system-on-chip (SOC) 400. The chip
connections and electronics package are not shown but are known in
the art.
[0075] Referring to FIG. 9, SBAs with variations on arrangements of
electrodes are shown. Each electrode may consist of a plurality of
conductive contacts that give the electrode abilities to adjust the
depth, directionality, and spatial distribution of the applied
electric field. For all the example electrode configurations shown,
901-904, the depth of the electrical stimulation can be controlled
by the voltage and power applied to the electrode contacts.
Electric current can be applied to various electrode contacts at
opposite end of the SBA, or within a plurality of electrode
contacts on a single end of the SBA. The phase relationship of the
signals applied to the electrode contacts can vary the
directionality of the electric field. For all configurations of
electrodes, the applied signals can vary over time and spatial
dimensions. The configuration on the left. 901, shows a plurality
of concentric electrode contacts at either end of the SBA. This
configuration can be used to apply an electric stimulating field at
various tissue depths by varying the power introduced to the
electrode contacts. The next configuration, 902, shows electrodes
404 that are arranged in a plurality of parallel strips of
electrical contacts. This allows the electric field to be oriented
perpendicular or parallel to the SBA. The next configuration, 903,
shows an example matrix of electrode contacts where the applied
signal can generate a stimulating field between any two or more
electrode contacts at either end of the SBA, or between two or more
electrode contacts within a single matrix at one end of the SBA.
Finally, the next configuration on the far right, 904, also shows
electrodes that are arranged in a plurality of parallel strips of
electrical contacts. As with the second configuration, this allows
the electric field to be oriented perpendicular or parallel to the
SBA. There may be many other arrangements of electrodes and
contacts.
[0076] One or more TNSSs with one or more Controllers form a
System. Systems can communicate and interact with each other and
with distributed virtualized processing and storage services. This
enables the gathering, exchange, and analysis of data among
populations of systems for medical and non-medical
applications.
[0077] Referring to FIG. 10, a system is shown with two TNSS units
1006, with one on the wrist, one on the leg, communicating with its
controller, a smartphone 1000 or other control device. The TNSS
units can be both sensing and stimulating and can act independently
and also work together in a Body Area Network (BAN). Systems
communicate with each other over a communication bridge or network
such as a cellular network. Systems also communicate with
applications running in a distributed virtualized processing and
storage environment generally via the Internet 1002. The purpose
for communications with the distributed virtualized processing and
storage
[0078] environment is to communicate large amounts of user data for
analysis and networking with other third parties such as hospitals,
doctors, insurance companies, researchers, and others. There are
applications that gather, exchange, and analyze data from multiple
Systems 1004. Third party application developers can access TNSS
systems and their data to deliver a wide range of applications.
These applications can return data or control signals to the
individual wearing the TNSS unit 1006. These applications can also
send data or control signals to other members of the population who
employ systems 1008. This may represent an individual's data,
aggregated data from a population of users, data analyses, or
supplementary data from other sources.
[0079] Referring to FIG. 11, shown is an example of an electrode
array to affect beam forming and beam steering. Beam forming and
steering allows a more selective application of stimulation energy
by a TNSS to nerves and tissue. Beam steering also provides the
opportunity for lower power for stimulation of cells including
nerves by applying the stimulating mechanism directionally to a
target. In the use of an electrical beam lower power demand
lengthens battery life and allows for use of low power chip sets.
Beam steering may be accomplished in multiple ways for instance by
magnetic fields and formed gates. FIG. 11 shows a method for
forming and steering a beam by the use of a plurality of radiators
1102 which are activated out of phase with each other by a
plurality of phase shifters 1103 that are supplied power from a
common source 1104. Because the radiated signals are out of phase
they produce an interference pattern 1105 that results in the beam
being formed and steered in varying controlled directions 1106.
Electromagnetic radiation like light shows some properties of waves
and can be focused on certain locations. This provides the
opportunity to stimulate tissues such as nerves selectively. It
also provides the opportunity to focus the transmission of energy
and data on certain objects, including topical or implanted
electronic devices, thereby not only improving the selectivity of
activating or controlling those objects but also reducing the
overall power required to operate them.
[0080] FIG. 12 is another example of a gating structure 1200 used
for beam shaping and steering 1202. The gating structure 1200 shows
an example of an interlocked pair of electrodes that can be used
for simple beam forming through the application of time-varying
voltages. The steering 1202 shows a generic picture of the main
field lobes and how such beam steering works in this example. FIG.
12 is illustrative of a possible example that may be used.
[0081] The human and mammal body is an anisotropic medium with
multiple layers of tissue of varying electrical properties.
Steering of an electric field may be accomplished using multiple
electrodes, or multiple SBAs, using the human or mammal body as an
anisotropic volume conductor. Electric field steering will
discussed below with reference to FIGS. 18 and 19.
[0082] Referring to FIG. 13, the controller is an electronics
platform that is a smartphone 1300, tablet 1302, personal computer
1304, or dedicated module 1306 that hosts wireless communications
capabilities, such as Near Field Communications. Bluetooth, or
Wi-Fi technologies as enabled by the current set of communications
chips, e.g. Broadcom BCM4334. TI WiLink 8 and others, and a wide
range of protocol apps that can communicate with the TNSSs. There
may be more than one controller, acting together. This may occur,
for example, if the user has both a smartphone control app running,
and a key fob controller in his/her pocket/purse.
[0083] TNSS protocol performs the functions of communications with
the controller including transmitting and receiving of control and
data signals, activation and control of the neural stimulation,
data gathering from on board sensors, communications and
coordination with other TNSSs, and data analysis. Typically the
TNSS may receive commands from the controller, generate stimuli and
apply these to the tissues, sense signals from the tissues, and
transmit these to the controller. It may also analyze the signals
sensed and use this information to modify the stimulation applied.
In addition to communicating with the controller it may also
communicate with other TNSSs using electrical or radio signals via
a body area network.
[0084] Referring to FIG. 14, controller protocol executed and/or
displayed on a smartphone 1400, tablet 1402 or other computing
platform or mobile device, will perform the functions of
communications with TNSS modules including transmitting and
receiving of control and data signals, activation and control of
the neuro modulation regimens, data gathering from on board
sensors, communications and coordination with other controllers,
and data analysis. In some cases local control of the neuro
modulation regimens may be conducted by controller protocol without
communications with the user.
[0085] FIG. 15 shows potential applications of electrical
stimulation and sensing for the body, particularly for users who
may suffer from paralysis or loss of sensation or altered reflexes
such as spasticity or tremor due to neurological disorders and
their complications, as well as users suffering from incontinence,
pain, immobility and aging. Different example medical uses of the
present system are discussed below.
[0086] FIG. 16 shows the components of one example of a typical
TNSS system 1600. TNSS devices 1610 are responsible for stimulation
of nerves and for receiving data in the form of electrical,
acoustic, imaging, chemical and other signals which then can be
processed locally in the TNSS or passed to the Control Unit 1620.
TNSS devices 1610 are also responsible for analysis and action. The
TNSS device 1610 may contain a plurality of electrodes for
stimulation and for sensing. The same electrodes may be used for
both functions, but this is not required. The TNSS device 1610 may
contain an imaging device, such as an ultrasonic transducer to
create acoustic images of the structure beneath the electrodes or
elsewhere in the body that may be affected by the neural
stimulation.
[0087] In this example TNSS system, most of the data gathering and
analysis is performed in the Control Unit 1620. The Control Unit
1620 may be a cellular telephone or a dedicated hardware device.
The Control Unit 1620 runs an app that controls the local functions
of the TNSS System 1600. The protocol app also communicates via the
Internet or wireless networks 1630 with other TNSS systems and/or
with 3rd party software applications.
[0088] FIG. 17 shows the communications among the components of the
TNSS system 1600 and the user. In this example, TNSS 1610 is
capable of applying stimuli to nerves 1640 to produce action
potentials in the nerves 1640 to produce actions in muscles 1670 or
other organs such as the brain 1650. These actions may be sensed by
the TNSS 1610, which may act on the information to modify the
stimulation it provides. This closed loop constitutes the first
level of the system 1600 in this example.
[0089] The TNSS 1610 may also be caused to operate by signals
received from a Control Unit 1620 such as a cellphone, laptop, key
fob, tablet, or other handheld device and may transmit information
that it senses back to the Control Unit 1620. This constitutes the
second level of the system 1600 in this example.
[0090] The Control Unit 1620 is caused to operate by commands from
a user, who also receives information from the Control Unit 1620.
The user may also receive information about actions of the body via
natural senses such as vision or touch via sensory nerves and the
spinal cord, and may in some cases cause actions in the body via
natural pathways through the spinal cord to the muscles.
[0091] The Control Unit 1620 may also communicate information to
other users, experts, or application programs via the Internet
1630, and receive information from them via the Internet 1630.
[0092] The user may choose to initiate or modify these processes,
sometimes using protocol applications residing in the TNSS 1610,
the Control Unit 1620, the Internet 1630, or wireless networks.
This software may assist the user, for example by processing the
stimulation to be delivered to the body to render it more selective
or effective for the user, and/or by processing and displaying data
received from the body or from the Internet 1630 or wireless
networks to make it more intelligible or useful to the user.
[0093] FIG. 18 shows an example electrode configuration 1800 for
Electric Field Steering. The application of an appropriate electric
field to the body can cause a nerve to produce an electrical pulse
known as an action potential. The shape of the electric field is
influenced by the electrical properties of the different tissue
through which it passes and the size, number and position of the
electrodes used to apply it. The electrodes can therefore be
designed to shape or steer or focus the electric field on some
nerves more than on others, thereby providing more selective
stimulation.
[0094] An example 10.times.10 matrix of electrical contacts 1860 is
shown. By varying the pattern of electrical contacts 1860 employed
to cause an electric field 1820 to form and by time varying the
applied electrical power to this pattern of contacts 1860, it is
possible to steer the field 1820 across different parts of the
body, which may include muscle 1870, bone, fat, and other tissue,
in three dimensions. This electric field 1820 can activate specific
nerves or nerve bundles 1880 while sensing the electrical and
mechanical actions produced 1890, and thereby enabling the TNSS to
discover more effective or the most effective pattern of
stimulation for producing the desired action.
[0095] FIG. 19 shows an example of stimulating and sensing patterns
of signals in a volume of tissue. Electrodes 1910 as part of a cuff
arrangement are placed around limb 1915. The electrodes 1910 are
external to a layer of skin 1916 on limb 1915. Internal components
of the limb 1915 include muscle 1917, bone 1918, nerves 1919, and
other tissues. By using electric field steering for stimulation, as
described with reference to FIG. 18, the electrodes 1910 can
activate nerves 1919 selectively. An array of sensors (e.g.,
piezoelectric sensors or micro-electro-mechanical sensors) in a
TNSS can act as a phased array antenna for receiving ultrasound
signals, to acquire ultrasonic images of body tissues. Electrodes
1910 may act as an array of electrodes sensing voltages at
different times and locations on the surface of the body, with
software processing this information to display information about
the activity in body tissues, e.g., which muscles are activated by
different patterns of stimulation.
[0096] The SBA's ability to stimulate and collect organic data has
multiple applications including bladder control, reflex
incontinence, sexual stimulations, pain control and wound healing
among others. Examples of SBA's application for medical and other
uses follow.
Medical Uses
[0097] Bladder Management
[0098] Overactive bladder: When the user feels a sensation of
needing to empty the bladder urgently, he or she presses a button
on the Controller to initiate stimulation via a Smart Band Aid.TM.
applied over the dorsal nerve of the penis or clitoris. Activation
of this nerve would inhibit the sensation of needing to empty the
bladder urgently, and allow it to be emptied at a convenient
time.
[0099] Incontinence: A person prone to incontinence of urine
because of unwanted contraction of the bladder uses the SBA to
activate the dorsal nerve of the penis or clitoris to inhibit
contraction of the bladder and reduce incontinence of urine. The
nerve could be activated continuously, or intermittently when the
user became aware of the risk of incontinence, or in response to a
sensor indicating the volume or pressure in the bladder.
[0100] Erection, ejaculation and orgasm: Stimulation of the nerves
on the underside of the penis by a Smart Band Aid.TM. (electrical
stimulation or mechanical vibration) can cause sexual arousal and
might be used to produce or prolong erection and to produce orgasm
and ejaculation.
[0101] Pain control: A person suffering from chronic pain from a
particular region of the body applies a Smart Band Aid.TM. over
that region and activates electrically the nerves conveying the
sensation of touch, thereby reducing the sensation of pain from
that region. This is based on the gate theory of pain.
[0102] Wound care: A person suffering from a chronic wound or ulcer
applies a Smart Band Aid.TM. over the wound and applies electrical
stimuli continuously to the tissues surrounding the wound to
accelerate healing and reduce infection.
[0103] Essential tremor: A sensor on a Smart Band Aid.TM. detects
the tremor and triggers neuro stimulation to the muscles and
sensory nerves involved in the tremor with an appropriate frequency
and phase relationship to the tremor. The stimulation frequency
would typically be at the same frequency as the tremor but shifted
in phase in order to cancel the tremor or reset the neural control
system for hand position.
[0104] Reduction of spasticity: Electrical stimulation of
peripheral nerves can reduce spasticity for several hours after
stimulation. A Smart Band Aid.TM. operated by the patient when
desired from a smartphone could provide this stimulation.
[0105] Restoration of sensation and sensory feedback: People who
lack sensation, for example as a result of diabetes or stroke use a
Smart Band Aid.TM. to sense movement or contact, for example of the
foot striking the floor, and the SBA provides mechanical or
electrical stimulation to another part of the body where the user
has sensation, to improve safety or function. Mechanical
stimulation is provided by the use of acoustic transducers in the
SBA such as small vibrators. Applying a Smart Band Aid.TM. to the
limb or other assistive device provides sensory feedback from
artificial limbs. Sensory feedback can also be used to substitute
one sense for another, e.g. touch in place of sight.
[0106] Recording of mechanical activity of the body: Sensors in a
Smart Band Aid.TM. record position, location and orientation of a
person or of body parts and transmit this data to a smartphone for
the user and/or to other computer networks for safety monitoring,
analysis of function and coordination of stimulation.
[0107] Recording of sound from the body or reflections of
ultrasound waves generated by a transducer in a Smart Band Aid.TM.
could provide information about body structure, e.g., bladder
volume for persons unable to feel their bladder. Acoustic
transducers may be piezoelectric devices or MEMS devices that
transmit and receive the appropriate acoustic frequencies. Acoustic
data may be processed to allow imaging of the interior of the
body.
[0108] Recording of Electrical Activity of the Body
[0109] Electrocardiogram: Recording the electrical activity of the
heart is widely used for diagnosing heart attacks and abnormal
rhythms. It is sometimes necessary to record this activity for 24
hours or more to detect uncommon rhythms. A Smart Band Aid.TM.
communicating wirelessly with a smartphone or computer network
achieves this more simply than present systems.
[0110] Electromyogram: Recording the electrical activity of muscles
is widely used for diagnosis in neurology and also used for
movement analysis. Currently this requires the use of many needles
or adhesive pads on the surface of the skin connected to recording
equipment by many wires. Multiple Smart Band Aids.TM. record the
electrical activity of many muscles and transmit this information
wirelessly to a smartphone.
[0111] Recording of optical information from the body: A Smart Band
Aid.TM. incorporating a light source (LED, laser) illuminates
tissues and senses the characteristics of the reflected light to
measure characteristics of value, e.g., oxygenation of the blood,
and transmit this to a cellphone or other computer network.
[0112] Recording of chemical information from the body: The levels
of chemicals or drugs in the body or body fluids is monitored
continuously by a Smart Band Aid.TM. sensor and transmitted to
other computer networks and appropriate feedback provided to the
user or to medical staff. Levels of chemicals may be measured by
optical methods (reflection of light at particular wavelengths) or
by chemical sensors.
[0113] Special Populations of Disabled Users
[0114] There are many potential applications of electrical
stimulation for therapy and restoration of function. However, few
of these have been commercialized because of the lack of affordable
convenient and easily controllable stimulation systems. Some
applications are shown in the FIG. 15.
[0115] Limb Muscle stimulation: Lower limb muscles can be exercised
by stimulating them electrically, even if they are paralyzed by
stroke or spinal cord injury. This is often combined with the use
of a stationary exercise cycle for stability. Smart Band Aid.TM.
devices could be applied to the quadriceps muscle of the thigh to
stimulate these, extending the knee for cycling, or to other
muscles such as those of the calf. Sensors in the Smart Band
Aid.TM. could trigger stimulation at the appropriate time during
cycling, using an application on a smartphone, tablet, handheld
hardware device such as a key fob, wearable computing device,
laptop, or desktop computer, among other possible devices. Upper
limb muscles can be exercised by stimulating them electrically,
even if they are paralyzed by stroke of spinal cord injury. This is
often combined with the use of an arm crank exercise machine for
stability. Smart Band Aid.TM. devices are applied to multiple
muscles in the upper limb and triggered by sensors in the Smart
Band Aids.TM. at the appropriate times, using an application on a
smartphone.
[0116] Prevention of osteoporosis: Exercise can prevent
osteoporosis and pathological fractures of bones. This is applied
using Smart Band Aids.TM. in conjunction with exercise machines
such as rowing simulators, even for people with paralysis who are
particularly prone to osteoporosis.
[0117] Prevention of deep vein thrombosis: Electric stimulation of
the muscles of the calf can reduce the risk of deep vein thrombosis
and potentially fatal pulmonary embolus. Electric stimulation of
the calf muscles is applied by a Smart Band Aid.TM. with
stimulation programmed from a smartphone, e.g., during a surgical
operation, or on a preset schedule during a long plane flight.
[0118] Restoration of Function (Functional Electrical Stimulation)
Lower Limb
[0119] 1) Foot drop: People with stroke often cannot lift their
forefoot and drag their toes on the ground. A Smart Band Aid.TM. is
be applied just below the knee over the common peroneal nerve to
stimulate the muscles that lift the forefoot at the appropriate
time in the gait cycle, triggered by a sensor in the Smart Band
Aid.TM.
[0120] 2) Standing: People with spinal cord injury or some other
paralyses can be aided to stand by electrical stimulation of the
quadriceps muscles of their thigh. These muscles are stimulated by
Smart Band Aids.TM. applied to the front of the thigh and triggered
by sensors or buttons operated by the patient using an application
on a smartphone. This may also assist patients to use lower limb
muscles when transferring from a bed to a chair or other
surface.
[0121] 3) Walking: Patients with paralysis from spinal cord injury
are aided to take simple steps using electrical stimulation of the
lower limb muscles and nerves. Stimulation of the sensory nerves in
the common peroneal nerve below the knee can cause a triple reflex
withdrawal, flexing the ankle, knee and hip to lift the leg, and
then stimulation of the quadriceps can extend the knee to bear
weight. The process is then repeated on the other leg. Smart Band
Aids.TM. coordinated by an application in a smartphone produce
these actions.
[0122] Upper Limb
[0123] Hand grasp: People with paralysis from stroke or spinal cord
injury have simple hand grasp restored by electrical stimulation of
the muscles to open or close the hand. This is produced by Smart
Band Aids.TM. applied to the back and front of the forearm and
coordinated by sensors in the Smart Band Aids.TM. and an
application in a smartphone.
[0124] Reaching: Patients with paralysis from spinal cord injury
sometimes cannot extend their elbow to reach above the head.
Application of a Smart Band Aid.TM. to the triceps muscle
stimulates this muscle to extend the elbow. This is triggered by a
sensor in the Smart Band Aid.TM. detecting arm movements and
coordinating it with an application on a smartphone.
[0125] Posture: People whose trunk muscles are paralyzed may have
difficulty maintaining their posture even in a wheelchair. They may
fall forward unless they wear a seatbelt, and if they lean forward
they may be unable to regain upright posture. Electrical
stimulation of the muscles of the lower back using a Smart Band
Aid.TM. allows them to maintain and regain upright posture. Sensors
in the Smart Band Aid.TM. trigger this stimulation when a change in
posture was detected.
[0126] Coughing: People whose abdominal muscles are paralyzed
cannot produce a strong cough and are at risk for pneumonia.
Stimulation of the muscles of the abdominal wall using a Smart Band
Aid.TM. could produce a more forceful cough and prevent chest
infections. The patient using a sensor in a Smart Band Aid.TM.
triggers the stimulation.
[0127] Essential Tremor: It has been demonstrated that neuro
stimulation can reduce or eliminate the signs of ET. ET may be
controlled using a TNSS. A sensor on a Smart Band Aid.TM. detects
the tremor and trigger neuro stimulation to the muscles and sensory
nerves involved in the tremor with an appropriate frequency and
phase relationship to the tremor. The stimulation frequency is
typically be at the same frequency as the tremor but shifted in
phase in order to cancel the tremor or reset the neural control
system for hand position.
Non-Medical Applications
[0128] Sports Training
[0129] Sensing the position and orientation of multiple limb
segments is used to provide visual feedback on a smartphone of, for
example, a golf swing, and also mechanical or electrical feedback
to the user at particular times during the swing to show them how
to change their actions. The electromyogram of muscles could also
be recorded from one or many Smart Band Aids.TM. and used for more
detailed analysis.
[0130] Gaming
[0131] Sensing the position and orientation of arms, legs and the
rest of the body produces a picture of an onscreen player that can
interact with other players anywhere on the Internet, Tactile
feedback would be provided to players by actuators in Smart Band
Aids on various parts of the body to give the sensation of striking
a ball, etc.
[0132] Motion Capture for Film and Animation
[0133] Wireless TNSS capture position, acceleration, and
orientation of multiple parts of the body. This data may be used
for animation of a human or mammal and has application for human
factor analysis and design.
Sample Modes of Operation
[0134] A SBA system consists of at least a single Controller and a
single SBA. Following application of the SBA to the user's skin,
the user controls it via the
[0135] Controller's app using Near Field Communications. The app
appears on a smartphone screen and can be touch controlled by the
user; for `key fob` type Controllers. The SBA is controlled by
pressing buttons on the key fob.
[0136] When the user feels the need to activate the SBA s/he
presses the "go" button two or more times to prevent false
triggering, thus delivering the neuro stimulation. The neuro
stimulation may be delivered in a variety of patterns of frequency,
duration, and strength and may continue until a button is pressed
by the user or may be delivered for a length of time set in the
application.
[0137] Sensor capabilities in the TNSS, are enabled to start
collecting/analyzing data and communicating with the controller
when activated.
[0138] The level of functionality in the protocol app, and the
protocol embedded in the TNSS, will depend upon the neuro
modulation or neuro stimulation regimen being employed.
[0139] In some cases there will be multiple TNSSs employed for the
neuro modulation or neuro stimulation regimen. The basic activation
will be the same for each TNSS.
[0140] However, once activated multiple TNSSs will automatically
form a network of neuro modulation/stimulation points with
communications enabled with the controller.
[0141] The need for multiple TNSSs arises from the fact that
treatment regimens may need several points of access to be
effective.
Controlling the Stimulation
[0142] In general, advantages of a wireless TNSS system as
disclosed herein over existing transcutaneous electrical nerve
stimulation devices include: (1) fine control of all stimulation
parameters from a remote device such as a smartphone, either
directly by the user or by stored programs; (2) multiple electrodes
of a TNSS can form an array to shape an electric field in the
tissues; (3) multiple TNSS devices can form an array to shape an
electric field in the tissues; (4) multiple TNSS devices can
stimulate multiple structures, coordinated by a smartphone; (5)
selective stimulation of nerves and other structures at different
locations and depths in a volume of tissue; (6) mechanical,
acoustic or optical stimulation in addition to electrical
stimulation; (7) the transmitting antenna of TNSS device can focus
a beam of electromagnetic energy within tissues in short bursts to
activate nerves directly without implanted devices; (8) inclusion
of multiple sensors of multiple modalities, including but not
limited to position, orientation, force, distance, acceleration,
pressure, temperature, voltage, light and other electromagnetic
radiation, sound, ions or chemical compounds, making it possible to
sense electrical activities of muscles (EMG, EKG), mechanical
effects of muscle contraction, chemical composition of body fluids,
location or dimensions or shape of an organ or tissue by
transmission and receiving of ultrasound.
[0143] Further advantages of the wireless TNSS system include: (1)
TNSS devices are expected to have service lifetimes of days to
weeks and their disposability places less demand on power sources
and battery requirements; (2) the combination of stimulation with
feedback from artificial or natural sensors for closed loop control
of muscle contraction and force, position or orientation of parts
of the body, pressure within organs, and concentrations of ions and
chemical compounds in the tissues; (3) multiple TNSS devices can
form a network with each other, with remote controllers, with other
devices, with the Internet and with other users; (4) a collection
of large amounts of data from one or many TNSS devices and one or
many users regarding sensing and stimulation, collected and stored
locally or through the internet; (5) analysis of large amounts of
data to detect patterns of sensing and stimulation, apply machine
learning, and improve algorithms and functions; (6) creation of
databases and knowledge bases of value; (7) convenience, including
the absence of wires to become entangled in clothing, showerproof
and sweat proof, low profile, flexible, camouflaged or skin
colored, (8) integrated power, communications, sensing and
stimulating inexpensive disposable TNSS, consumable electronics;
(9) power management that utilizes both hardware and software
functions will be critical to the convenience factor and widespread
deployment of TNSS device.
[0144] Referring again to FIG. 1, a nerve cell normally has a
voltage across the cell membrane of 70 millivolts with the interior
of the cell at a negative voltage with respect to the exterior of
the cell. This is known as the resting potential and it is normally
maintained by metabolic reactions which maintain different
concentrations of electrical ions in the inside of the cell
compared to the outside. Ions can be actively "pumped" across the
cell membrane through ion channels in the membrane that are
selective for different types of ion, such as sodium and potassium.
The channels are voltage sensitive and can be opened or closed
depending on the voltage across the membrane. An electric field
produced within the tissues by a stimulator can change the normal
resting voltage across the membrane, either increasing or
decreasing the voltage from its resting voltage.
[0145] Referring again to FIG. 2, a decrease in voltage across the
cell membrane to about 55 millivolts opens certain ion channels,
allowing ions to flow through the membrane in a self-catalyzing but
self-limited process which results in a transient decrease of the
trans membrane potential to zero, and even positive, known as
depolarization followed by a rapid restoration of the resting
potential as a result of active pumping of ions across the membrane
to restore the resting situation which is known as repolarization.
This transient change of voltage is known as an action potential
and it typically spreads over the entire surface of the cell. If
the shape of the cell is such that it has a long extension known as
an axon, the action potential spreads along the length of the axon.
Axons that have insulating myelin sheaths propagate action
potentials at much higher speeds than those axons without myelin
sheaths or with damaged myelin sheaths.
[0146] If the action potential reaches a junction, known as a
synapse, with another nerve cell, the transient change in membrane
voltage results in the release of chemicals known as
neuro-transmitters that can initiate an action potential in the
other cell. This provides a means of rapid electrical communication
between cells, analogous to passing a digital pulse from one cell
to another.
[0147] If the action potential reaches a synapse with a muscle cell
it can initiate an action potential that spreads over the surface
of the muscle cell. This voltage change across the membrane of the
muscle cell opens ion channels in the membrane that allow ions such
as sodium, potassium and calcium to flow across the membrane, and
can result in contraction of the muscle cell.
[0148] Increasing the voltage across the membrane of a cell below
-70 millivolts is known as hyper-polarization and reduces the
probability of an action potential being generated in the cell.
This can be useful for reducing nerve activity and thereby reducing
unwanted symptoms such as pain and spasticity
[0149] The voltage across the membrane of a cell can be changed by
creating an electric field in the tissues with a stimulator. It is
important to note that action potentials are created within the
mammalian nervous system by the brain, the sensory nervous system
or other internal means. These action potentials travel along the
body's nerve "highways". The TNSS creates an action potential
through an externally applied electric field from outside the body.
This is very different than how action potentials are naturally
created within the body.
[0150] Electric Fields that can Cause Action Potentials
[0151] Referring to FIG. 2, electric fields capable of causing
action potentials can be generated by electronic stimulators
connected to electrodes that are implanted surgically in close
proximity to the target nerves. To avoid the many issues associated
with implanted devices, it is desirable to generate the required
electric fields by electronic devices located on the surface of the
skin. Such devices typically use square wave pulse trains of the
form shown in FIG. 20. Such devices may be used instead of implants
and/or with implants such as reflectors, conductors, refractors, or
markers for tagging target nerves and the like, so as to shape
electric fields to enhance nerve targeting and/or selectivity.
[0152] Referring to FIG. 20, the amplitude of the pulses "A",
applied to the skin, may vary between 1 and 100 Volts, pulse width
"t", between 100 microseconds and 10 milliseconds, duty cycle (t/T)
between 0.1% and 50%, the frequency of the pulses within a group
between 1 and 100/sec, and the number of pulses per group "n",
between 1 and several hundred. Typically, pulses applied to the
skin will have an amplitude of up to 60 volts, a pulse width of 250
microseconds and a frequency of 20 per second, resulting in a duty
cycle of 0.5%. In some cases balanced-charge biphasic pulses will
be used to avoid net current flow. Referring to FIG. 21, these
pulses may be symmetrical, with the shape of the first part of the
pulse similar to that of the second part of the pulse, or
asymmetrical, in which the second part of the pulse has lower
amplitude and a longer pulse width in order to avoid canceling the
stimulatory effect of the first part of the pulse.
[0153] Formation of Electric Fields by Stimulators
[0154] The location and magnitude of the electric potential applied
to the tissues by electrodes provides a method of shaping the
electrical field. For example, applying two electrodes to the skin,
one at a positive electrical potential with respect to the other,
can produce a field in the underlying tissues such as that shown in
the cross-sectional diagram of FIG. 22.
[0155] The diagram in FIG. 22 assumes homogeneous tissue. The
voltage gradient is highest close to the electrodes and lower at a
distance from the electrodes. Nerves are more likely to be
activated close to the electrodes than at a distance. For a given
voltage gradient, nerves of large diameter are more likely to be
activated than nerves of smaller diameter. Nerves whose long axis
is aligned with the voltage gradient are more likely to be
activated than nerves whose long axis is at right angles to the
voltage gradient.
[0156] Applying similar electrodes to a part of the body in which
there are two layers of tissue of different electrical resistivity,
such as fat and muscle, can produce a field such as that shown in
FIG. 23. Layers of different tissue may act to refract and direct
energy waves and be used for beam aiming and steering. An
individual's tissue parameters may be measured and used to
characterize the appropriate energy stimulation for a selected
nerve.
[0157] Referring to FIG. 24, when the stimulating pulse is turned
off the electric field will collapse and the fields will be absent
as shown. It is the change in electric field that will cause an
action potential to be created in a nerve cell, provided sufficient
voltage and the correct orientation of the electric field occurs.
More complex three-dimensional arrangements of tissues with
different electrical properties can result in more complex
three-dimensional electric fields, particularly since tissues have
different electrical properties and these properties are different
along the length of a tissue and across it, as shown in Table
1.
TABLE-US-00001 TABLE 1 Electrical Conductivity (siemens/m)
Direction Average Blood .65 Bone Along .17 Bone Mixed .095 Fat .05
Muscle Along .127 Muscle Across .45 Muscle Mixed .286 Skin (Dry)
.000125 Skin (Wet) .00121
[0158] Modification of Electric Fields by Tissue
[0159] An important factor in the formation of electric fields used
to create action potentials in nerve cells is the medium through
which the electric fields must penetrate. For the human body this
medium includes various types of tissue including bone, fat,
muscle, and skin. Each of these tissues possesses different
electrical resistivity or conductivity and different capacitance
and these properties are anisotropic. They are not uniform in all
directions within the tissues. For example, an axon has lower
electrical resistivity along its axis than perpendicular to its
axis. The wide range of conductivities is shown in Table 1. The
three-dimensional structure and resistivity of the tissues will
therefore affect the orientation and magnitude of the electric
field at any given point in the body.
[0160] Modification of Electric Fields by Multiple Electrodes
[0161] Applying a larger number of electrodes to the skin can also
produce more complex three-dimensional electrical fields that can
be shaped by the location of the electrodes and the potential
applied to each of them. Referring to FIG. 20, the pulse trains can
differ from one another indicated by A, t/T, n, and f as well as
have different phase relationships between the pulse trains. For
example with an 8.times.8 array of electrodes, combinations of
electrodes can be utilized ranging from simple dipoles, to
quadripoles, to linear arrangements, to approximately circular
configurations, to produce desired electric fields within
tissues.
[0162] Applying multiple electrodes to a part of the body with
complex tissue geometry will thus result in an electric field of a
complex shape. The interaction of electrode arrangement and tissue
geometry can be modeled using Finite Element Modeling, which is a
mathematical method of dividing the tissues into many small
elements in order to calculate the shape of a complex electric
field. This can be used to design an electric field of a desired
shape and orientation to a particular nerve.
[0163] High frequency techniques known for modifying an electric
field, such as the relation between phases of a beam, cancelling
and reinforcing by using phase shifts, may not apply to application
of electric fields by TNSSs because they use low frequencies.
Instead, examples use beam selection to move or shift or shape an
electric field, also described as field steering or field shaping,
by activating different electrodes, such as from an array of
electrodes, to move the field. Selecting different combinations of
electrodes from an array may result in beam or field steering. A
particular combination of electrodes may shape a beam and/or change
the direction of a beam by steering. This may shape the electric
field to reach a target nerve selected for stimulation.
[0164] Activation of Nerves by Electric Fields
[0165] Typically, selectivity in activating nerves has required
electrodes to be implanted surgically on or near nerves. Using
electrodes on the surface of the skin to focus activation
selectively on nerves deep in the tissues, as with examples of the
invention, has many advantages. These include avoidance of surgery,
avoidance of the cost of developing complex implants and gaining
regulatory approval for them, and avoidance of the risks of
long-term implants.
[0166] The features of the electric field that determine whether a
nerve will be activated to produce an action potential can be
modeled mathematically by the "Activating Function" disclosed in
Rattay F., "The basic mechanism for the electrical stimulation of
the nervous system". Neuroscience Vol. 89. No. 2, pp. 335-346
(1999). The electric field can produce a voltage, or extracellular
potential, within the tissues that varies along the length of a
nerve. If the voltage is proportional to distance along the nerve,
the first order spatial derivative will be constant and the second
order spatial derivative will be zero. If the voltage is not
proportional to distance along the nerve, the first order spatial
derivative will not be constant and the second order spatial
derivative will not be zero. The Activating Function is
proportional to the second-order spatial derivative of the
extracellular potential along the nerve. If it is sufficiently
greater than zero at a given point it predicts whether the electric
field will produce an action potential in the nerve at that point.
This prediction may be input to a nerve signature.
[0167] In practice, this means that electric fields that are
varying sufficiently greatly in space or time can produce action
potentials in nerves. These action potentials are also most likely
to be produced where the orientation of the nerves to the fields
change, either because the nerve or the field changes direction.
The direction of the nerve can be determined from anatomical
studies and imaging studies such as MRI scans. The direction of the
field can be determined by the positions and configurations of
electrodes and the voltages applied to them, together with the
electrical properties of the tissues. As a result, it is possible
to activate certain nerves at certain tissue locations selectively
while not activating others.
[0168] To accurately control an organ or muscle, the nerve to be
activated must be accurately selected. This selectivity may be
improved by using examples disclosed herein as a nerve signature,
in several ways, as follows: [0169] (1) Improved algorithms to
control the effects when a nerve is stimulated, for example, by
measuring the resulting electrical or mechanical activity of
muscles and feeding back this information to modify the stimulation
and measuring the effects again. Repeated iterations of this
process can result in optimizing the selectivity of the
stimulation, either by classical closed loop control or by machine
learning techniques such as pattern recognition and artificial
intelligence; [0170] (2) Improving nerve selectivity by labeling or
tagging nerves chemically: for example, introduction of genes into
some nerves to render them responsive to light or other
electromagnetic radiation can result in the ability to activate
these nerves and not others when light or electromagnetic radiation
is applied from outside the body; [0171] (3) Improving nerve
selectivity by the use of electrical conductors to focus an
electric field on a nerve; these conductors might be implanted, but
could be passive and much simpler than the active implantable
medical devices currently used; [0172] (4) The use of reflectors or
refractors, either outside or inside the body, is used to focus a
beam of electromagnetic radiation on a nerve to improve nerve
selectivity. If these reflectors or refractors are implanted, they
may be passive and much simpler than the active implantable medical
devices currently used; [0173] (5) Improving nerve selectivity by
the use of feedback from the person upon whom the stimulation is
being performed; this may be an action taken by the person in
response to a physical indication such as a muscle activation or a
feeling from one or more nerve activations; [0174] (6) Improving
nerve selectivity by the use of feedback from sensors associated
with the TNSS, or separately from other sensors, that monitor
electrical activity associated with the stimulation; and [0175] (7)
Improving nerve selectivity by the combination of feedback from
both the person or sensors and the TNSS that may be used to create
a unique profile of the user's nerve physiology for selected nerve
stimulation.
[0176] Potential applications of electrical stimulation to the
body, as previously disclosed, are shown in FIG. 15.
[0177] Referring to FIG. 25A, a TNSS 934 human and mammalian
interface and its method of operation and supporting system are
managed by a Master Control Program ("MCP") 910 represented in
function format as block diagrams. It provides the logic for the
nerve stimulator system in accordance to one example.
[0178] In one example, MCP 910 and other components shown in FIG.
25A are implemented by one or more processors that are executing
instructions. The processor may be any type of general or specific
purpose processor. Memory is included for storing information and
instructions to be executed by the processor. The memory can be
comprised of any combination of random access memory (`RAM`), read
only memory ("ROM"), static storage such as a magnetic or optical
disk, or any other type of computer readable media.
[0179] Master Control Program
[0180] The primary responsibility of MCP 910 is to coordinate the
activities and communications among the various control programs, a
Data Manager 920, a User 932, and the external ecosystem and to
execute the appropriate response algorithms in each situation. The
MCP 910 accomplishes electric field shaping and/or beam steering by
providing an electrode activation pattern to TNSS device 934 to
selectively stimulate a target nerve. For example, upon
notification by a Communications Controller 930 of an external
event or request, the MCP 910 is responsible for executing the
appropriate response, and working with the Data Manager 920 to
formulate the correct response and actions. It integrates data from
various sources such as Sensors 938 and external inputs such as
TNSS devices 934, and applies the correct security and privacy
policies, such as encryption and HIPAA required protocols. It will
also manage the User Interface (UI) 912 and the various Application
Program Interfaces (APIs) 914 that provide access to external
programs.
[0181] MCP 910 is also responsible for effectively managing power
consumption by TNSS device 934 through a combination of software
algorithms and hardware components that may include, among other
things: computing, communications, and stimulating electronics,
antenna, electrodes, sensors, and power sources in the form of
conventional or printed batteries.
[0182] Communications Controller
[0183] Communications controller 930 is responsible for receiving
inputs from the User 932, from a plurality of TNSS devices 934, and
from 3rd party apps 936 via communications sources such as the
Internet or cellular networks. The format of such inputs will vary
by source and must be received, consolidated, possibly reformatted,
and packaged for the Data Manager 920.
[0184] User inputs may include simple requests for activation of
TNSS devices 934 to status and information concerning the User's
932 situation or needs. TNSS devices 934 will provide signaling
data that may include voltage readings, TNSS 934 status data,
responses to control program inquiries, and other signals.
[0185] Communications Controller 930 is also responsible for
sending data and control requests to the plurality of TNSS devices
934. 3rd party applications 936 can send data, requests, or
instructions for the Master Control Program 910 or User 932 via the
Internet or cellular networks. Communications Controller 930 is
also responsible for communications via the cloud where various
software applications may reside.
[0186] In one example, a user can control one or more TNSS devices
using a remote fob or other type of remote device and a
communication protocol such as Bluetooth. In one example, a mobile
phone is also in communication and functions as a central device
while the fob and TNSS device function as peripheral devices. In
another example, the TNSS device functions as the central device
and the fob is a peripheral device that communicates directly with
the TNSS device (i.e., a mobile phone or other device is not
needed).
[0187] Data Manager
[0188] The Data Manager (DM) 920 has primary responsibility for the
storage and movement of data to and from the Communications
Controller 930, Sensors 938, Actuators 940, and the Master Control
Program 910. The DM 920 has the capability to analyze and correlate
any of the data under its control. It provides logic to select and
activate nerves. Examples of such operations upon the data include:
statistical analysis and trend identification; machine learning
algorithms; signature analysis and pattern recognition,
correlations among the data within the Data Warehouse 926, the
Therapy Library 922, the Tissue Models 924, and the Electrode
Placement Models 928, and other operations. There are several
components to the data that is under its control as disclosed
below.
[0189] The Data Warehouse (DW) 926 is where incoming data is
stored; examples of this data can be real-time measurements from
TNSS devices 934 or from Sensors (938), data streams from the
Internet, or control and instructional data from various sources.
The DM 920 will analyze data, as described above, that is held in
the DW 926 and cause actions, including the export of data, under
MCP 910 control. Certain decision making processes implemented by
the DM 920 will identify data patterns both in time, frequency, and
spatial domains and store them as signatures for reference by other
programs. Techniques such as EMG, or multi-electrode EMG, gather a
large amount of data that is the sum of hundreds to thousands of
individual motor units and the typical procedure is to perform
complex decomposition analysis on the total signal to attempt to
tease out individual motor units and their behavior. The DM 920
will perform big data analysis over the total signal and recognize
patterns that relate to specific actions or even individual nerves
or motor units. This analysis can be performed over data gathered
in time from an individual, or over a population of TNSS Users.
[0190] The Therapy Library 922 contains various control regimens
for the TNSS devices 934. Regimens specify the parameters and
patterns of pulses to be applied by the TNSS devices 934. The width
and amplitude of individual pulses may be specified to stimulate
nerve axons of a particular size selectively without stimulating
nerve axons of other sizes. The frequency of pulses applied may be
specified to modulate some reflexes selectively without modulating
other reflexes. There are preset regimens that may be loaded from
the Cloud 942 or 3rd party apps 936. The regimens may be static
read-only as well as adaptive with read-write capabilities so they
can be modified in real-time responding to control signals or
feedback signals or software updates. Referring to FIG. 3, one such
example of a regimen has parameters A=40 volts, t=500 microseconds,
T=1 Millisecond, n=100 pulses per group, and f=20 per second. Other
examples of regimens will vary the parameters within ranges
previously specified.
[0191] The Tissue Models 924 is specific to the electrical
properties of particular body locations where TNSS devices 934 may
be placed. As previously disclosed, electric fields for production
of action potentials will be affected by the different electrical
properties of the various tissues that they encounter. Tissue
Models 924 are combined with regimens from the Therapy Library 922
and Electrode Placement Models 928 to produce desired actions.
Tissue Models 924 may be developed by MRI, Ultrasound or other
imaging or measurement of tissue of a body or particular part of a
body. This may be accomplished for a particular User 932 and/or
based upon a body norm. One such example of a desired action is the
use of a Tissue Model 924 together with a particular Electrode
Placement Model 928 to determine how to focus the electric field
from electrodes on the surface of the body on a specific deep
location corresponding to the pudendal nerve in order to stimulate
that nerve selectively to reduce incontinence of urine. Other
examples of desired actions may occur when a Tissue Model 924 in
combination with regimens from the Therapy Library 22 and Electrode
Placement Models 928 produce an electric field that stimulates a
sacral nerve. Many other examples of desired actions follow for the
stimulation of other nerves.
[0192] Electrode Placement Models 928 specify electrode
configurations that the TNSS devices 934 may apply and activate in
particular locations of the body. For example, a TNSS device 934
may have multiple electrodes and the Electrode Placement Model 928
specifies where these electrodes should be placed on the body and
which of these electrodes should be active in order to stimulate a
specific structure selectively without stimulating other
structures, or to focus an electric field on a deep structure. An
example of an electrode configuration is a 4 by 4 set of electrodes
within a larger array of multiple electrodes, such as an 8 by 8
array. This 4 by 4 set of electrodes may be specified anywhere
within the larger array such as the upper right corner of the 8 by
8 array. Other examples of electrode configurations may be circular
electrodes that may even include concentric circular electrodes.
The TNSS device 934 may contain a wide range of multiple electrodes
of which the Electrode Placement Models 928 will specify which
subset will be activated. The Electrode Placement Models 928
complement the regimens in the Therapy Library 922 and the Tissue
Models 924 and are used together with these other data components
to control the electric fields and their interactions with nerves,
muscles, tissues and other organs. Other examples may include TNSS
devices 934 having merely one or two electrodes, such as but not
limited to those utilizing a closed circuit.
[0193] Sensor/Actuator Control
[0194] Independent sensors 938 and actuators 940 can be part of the
TNSS system. Its functions can complement the electrical
stimulation and electrical feedback that the TNSS devices 934
provide. An example of such a sensor 938 and actuator 940 include,
but are not limited to, an ultrasonic actuator and an ultrasonic
receiver that can provide real-time image data of nerves, muscles,
bones, and other tissues. Other examples include electrical sensors
that detect signals from stimulated tissues or muscles. The
Sensor/Actuator Control module 950 provides the ability to control
both the actuation and pickup of such signals, all under control of
the MCP 910.
[0195] Application Program Interfaces
[0196] The MCP 910 is also responsible for supervising the various
Application Program Interfaces (APIs) that will be made available
for 3rd party developers. There may exist more than one API 914
depending upon the specific developer audience to be enabled. For
example many statistical focused apps will desire access to the
Data Warehouse 926 and its cumulative store of data recorded from
TNSS 934 and User 932 inputs. Another group of healthcare
professionals may desire access to the Therapy Library 922 and
Tissue Models 924 to construct better regimens for addressing
specific diseases or disabilities. In each case a different
specific API 914 may be appropriate.
[0197] The MCP 910 is responsible for many software functions of
the TNSS system including system maintenance, debugging and
troubleshooting functions, resource and device management, data
preparation, analysis, and communications to external devices or
programs that exist on the smart phone or in the cloud, and other
functions. However, one of its primary functions is to serve as a
global request handler taking inputs from devices handled by the
Communications Controller 930, external requests from the Sensor
Control Actuator Module (950), and 3rd party requests 936. Examples
of High Level Master Control Program (MCP) functions are disclosed
below.
[0198] The manner in which the MCP handles these requests is shown
in FIG. 25B. The Request Handler (RH) 960 accepts inputs from the
User 932, TNSS devices 934, 3rd party apps 936, sensors 938 and
other sources. It determines the type of request and dispatches the
appropriate response as set forth in the following paragraphs.
[0199] User Request: The RH 960 will determine which of the
plurality of User Requests 961 is present such as: activation;
display status, deactivation, or data input, e.g. specific User
condition. Shown in FIG. 25B is the RH's 960 response to an
activation request. As shown in block 962, RH 960 will access the
Therapy Library 922 and cause the appropriate regimen to be sent to
the correct TNSS 934 for execution, as shown at block 964 labeled
"Action."
[0200] TNSS/Sensor Inputs: The RH 960 will perform data analysis
over TNSS 934 or Sensor inputs 965. As shown at block 966, it
employs data analysis, which may include techniques ranging from
DSP decision-making processes, image processing algorithms,
statistical analysis and other algorithms to analyze the inputs. In
FIG. 25B two such analysis results are shown; conditions which
cause a User Alarm 970 to be generated and conditions which create
an Adaptive Action 980 such as causing a control feedback loop for
specific TNSS 934 functions, which can iteratively generate further
TNSS 934 or Sensor inputs 965 in a closed feedback loop.
[0201] 3rd Party Apps: Applications can communicate with the MCP
910, both sending and receiving communications. A typical
communication would be to send informational data or commands to a
TNSS 934. The RH 960 will analyze the incoming application data, as
shown at block 972. FIG. 25B shows two such actions that result.
One action, shown at block 974 would be the presentation of the
application data, possibly reformatted, to the User 932 through the
MCP User Interface 912. Another result would be to perform a User
932 permitted action, as shown at 976, such as requesting a regimen
from the Therapy Library 922.
[0202] Referring to FIG. 26, an example TNSS in accordance to one
example is shown. The TNSS has one or more electronic circuits or
chips 2600 that perform the functions of: communications with the
controller, nerve stimulation via electrodes 2608 that produce a
wide range of electric field(s) according to treatment regimen, one
or more antennae 2610 that may also serve as electrodes and
communication pathways, and a wide range of sensors 2606 such as,
but not limited to, mechanical motion and pressure, temperature,
humidity, chemical and positioning sensors. In another example,
TNSS interfaces to transducers 2614 to transmit signals to the
tissue or to receive signals from the tissue.
[0203] One arrangement is to integrate a wide variety of these
functions into an SOC, system on chip 2600. Within this is shown a
control unit 2602 for data processing, communications, transducer
interface and storage and one or more stimulators 2604 and sensors
2606 that are connected to electrodes 2608. An antenna 2610 is
incorporated for external communications by the control unit. Also
present is an internal power supply 2612, which may be, for
example, a battery. An external power supply is another variation
of the chip configuration. It may be necessary to include more than
one chip to accommodate a wide range of voltages for data
processing and stimulation. Electronic circuits and chips will
communicate with each other via conductive tracks within the device
capable of transferring data and/or power.
[0204] The TNSS interprets a data stream from the control device,
such as that shown in FIG. 25A, to separate out message headers and
delimiters from control instructions. In one example, control
instructions contain information such as voltage level and pulse
pattern. The TNSS activates the stimulator 2604 to generate a
stimulation signal to the electrodes 2608 placed on the tissue
according to the control instructions. In another example the TNSS
activates a transducer 2614 to send a signal to the tissue. In
another example, control instructions cause information such as
voltage level and pulse pattern to be retrieved from a library
stored in the TNSS.
[0205] The TNSS receives sensory signals from the tissue and
translates them to a data stream that is recognized by the control
device, such as the example in FIG. 25A. Sensory signals include
electrical, mechanical, acoustic, optical and chemical signals
among others. Sensory signals come to the TNSS through the
electrodes 2608 or from other inputs originating from mechanical,
acoustic, optical, or chemical transducers. For example, an
electrical signal from the tissue is introduced to the TNSS through
the electrodes 2608, is converted from an analog signal to a
digital signal and then inserted into a data stream that is sent
through the antenna 2610 to the control device. In another example
an acoustic signal is received by a transducer 2614 in the TNSS,
converted from an analog signal to a digital signal and then
inserted into a data stream that is sent through the antenna 2610
to the control device. In certain examples sensory signals from the
tissue are directly interfaced to the control device for
processing.
[0206] An open loop protocol to control current to electrodes in
known neural stimulation devices does not have feedback controls.
It commands a voltage to be set, but does not check the actual
Voltage. Voltage control is a safety feature. A stimulation pulse
is sent based on preset parameters and cannot be modified based on
feedback from the patient's anatomy. When the device is removed and
repositioned, the electrode placement varies. Also the humidity and
temperature of the anatomy changes throughout the day. All these
factors affect the actual charge delivery if the voltage is
preset.
[0207] In contrast, examples of the TNSS stimulation device have
features that address these shortcomings using the Nordic
Semiconductor nRF52832 microcontroller to regulate charge in a
TNSS. The High Voltage Supply is implemented using a LED driver
chip combined with a Computer controlled Digital Potentiometer to
produce a variable voltage. A 3-1 step up Transformer then provides
the desired High Voltage, "VBOOST", which is sampled to assure that
no failure causes an incorrect Voltage level as follows. The
nRF52832 Microcontroller samples the voltage of the stimulation
waveform providing feedback and impedance calculations for an
adaptive protocol to modify the waveform in real time. The Current
delivered to the anatomy by the stimulation waveform is integrated
using a differential integrator and sampled and then summed to
determine actual charge delivered to the user for a Treatment.
After every pulse in a Stimulation event, this measurement is
analyzed and used to modify, in real time, subsequent pulses.
[0208] This hardware adaptation allows a firmware protocol to
implement the adaptive protocol. This protocol regulates the charge
applied to the body by changing VBOOST. A treatment is performed by
a sequence of periodic pulses, which insert charge into the body
through the electrodes. Some of the parameters of the treatment are
fixed and some are user adjustable. The strength, duration and
frequency may be user adjustable. The user may adjust these
parameters as necessary for comfort and efficacy. The strength may
be lowered if there is discomfort and raised if nothing is felt.
The duration will be increased if the maximum acceptable strength
results in an ineffective treatment.
[0209] A flow diagram in accordance with one example of the
Adaptive Protocol disclosed above is shown in FIG. 27. The Adaptive
Protocol strives to repeatedly and reliably deliver a target charge
("Q.sub.target") during a treatment and to account for any
environmental changes. Therefore, the functionality of FIG. 27 is
to adjust the charge level applied to a user based on feedback,
rather than use a constant level.
[0210] The mathematical expression of this protocol is as
follows:
Q.sub.target=Q.sub.target(A*dS+B*dT), where A is the Strength
Coefficient-determined empirically, dS is the user change in
Strength, B is the Duration Coefficient-determined empirically, and
dT is the user change in Duration.
[0211] The Adaptive Protocol includes two phases in one example:
Acquisition 2700 and Reproduction 2720. Any change in user
parameters places the Adaptive Protocol in the Acquisition phase.
When the first treatment is started, a new baseline charge is
computed based on the new parameters. At a new acquisition phase at
2702, all data from the previous charge application is discarded.
In one example, 2702 indicates the first time for the current usage
where the user places the TNSS device on a portion of the body and
manually adjusts the charge level, which is a series of charge
pulses, until it feels suitable, or any time the charge level is
changed, either manually or automatically. The treatment then
starts. The mathematical expression of this function of the
application of a charge is as follows:
The charge delivered in a treatment is
Q target = i = 1 T * f Q pulse ( i ) ##EQU00001##
Where T is the duration; f is the frequency of "Rep Rate";
Q.sub.pulse (i) is the measured charge delivered by Pulse (i) in
the treatment pulse train provided as a voltage MON_CURRENT that is
the result of a Differential Integrator circuit shown in FIG. 28
(i.e., the average amount of charge per pulse). The Nordic
microcontroller of FIG. 28 is an example of an Analog to Digital
Conversion feature used to quantify voltage into a number
representing the delivered charge and therefore determine the
charge output. The number of pulses in the treatment is T*f.
[0212] At 2704 and 2706, every pulse is sampled. In one example,
the functionality of 2704 and 2706 lasts for 10 seconds with a
pulse rate of 20 Hz, which can be considered a full treatment
cycle. The result of phase 2700 is the target pulse charge of
Q.sub.target.
[0213] FIG. 29 is a table in accordance with one example showing
the number of pulses per treatment measured against two parameters,
frequency and duration. Frequency is shown on the Y-axis and
duration on the X-axis. The Adaptive Current protocol in general
performs better when using more pulses. One example uses a minimum
of 100 pulses to provide for solid convergence of charge data
feedback. Referring to the FIG. 29, a frequency setting of 20 Hz
and duration of 10 seconds produces 200 pulses, which is desirable
to allow the Adaptive Current Protocol to reproduce a previous
charge.
[0214] The reproduction phase 2720 begins in one example when the
user initiates another subsequent treatment after acquisition phase
2700 and the resulting acquisition of the baseline charge,
Q.sub.target. For example, a full treatment cycle, as discussed
above, may take 10 seconds. After, for example, a two-hour pause as
shown at wait period 2722, the user may then initiate another
treatment. During this phase, the Adaptive Current Protocol
attempts to deliver Q.sub.target for each subsequent treatment. The
functionality of phase 2720 is needed because, during the wait
period 2722, conditions such as the impedance of the user's body
due to sweat or air humidity may have changed. The differential
integrator is sampled at the end of each Pulse in the Treatment. At
that point, the next treatment is started and the differential
integrator is sampled for each pulse at 2724 for purposes of
comparison to the acquisition phase Q.sub.target. Sampling the
pulse includes measuring the output of the pulse in coulombs. The
output of the integrator of FIG. 28 in voltage, referred to as
Mon_Current 2801, is a direct linear relationship to the delivered
charge in micro-coulombs and provides a reading of how much charge
is leaving the device and entering the user. At 2726, each single
pulse is compared to the charge value determined in phase 2700
(i.e., the target charge) and the next pulse will be adjusted in
the direction of the difference.
NUM_PULSES=(T*f)
After each pulse, the observed charge. Q.sub.pulse(i), is compared
to the expected charge per pulse.
Q.sub.pulse(i)>Q.sub.target/NUM_PULSES ?
The output charge or "VBOOST" is then modified at either 2728
(decreasing) or 2730 (increasing) for the subsequent pulse by:
dV(i)=G[Q.sub.target/NUM_PULSES-Q.sub.pulse(i)]
where G is the Voltage adjustment Coefficient--determined
empirically. The process continues until the last pulse at
2732.
[0215] A safety feature assures that the VBOOST will never be
adjusted higher by more than 10%. If more charge is necessary, then
the repetition rate or duration can be increased.
[0216] In one example, in general, the current is sampled for every
pulse during acquisition phase 2700 to establish target charge for
reproduction. The voltage is then adjusted via a digital
potentiometer, herein referred to as "Pot", during reproduction
phase 2720 to achieve the established target_charge.
[0217] The digital Pot is calibrated with the actual voltage at
startup. A table is generated with sampled voltage for each wiper
value. Tables are also precomputed storing the Pot wiper increment
needed for 1 v and 5 v output delta at each pot level. This enables
quick reference for voltage adjustments during the reproduction
phase. The tables may need periodic recalibration due to battery
level.
[0218] In one example, during acquisition phase 2700, the minimum
data set=100 pulses and every pulse is sampled and the average is
used as the target_charge for reproduction phase 2720. In general,
less than 100 pulses may provide an insufficient data sample to use
as a basis for reproduction phase 2720. In one example, the default
treatment is 200 pulses (i.e., 20 Hz for 10 seconds). In one
example, a user can adjust both duration and frequency
manually.
[0219] In one example, during acquisition phase 2700, the maximum
data set=1000 pulses. The maximum is used to avoid overflow of 32
bit integers in accumulating the sum of samples. Further, 1000
pulses in one example is a sufficiently large data set and
collecting more is likely unnecessary.
[0220] After 1000 pulses for the above example, the target_charge
is computed. Additional pulses beyond 1000 in the acquisition phase
do not contribute to the computation of the target charge.
[0221] In one example, the first 3-4 pulses are generally higher
than the rest so these are not used in acquisition phase 2700. This
is also accounted for in reproduction phase 2720. Using these too
high values can result in target charge being set too high and over
stimulating on the subsequent treatments in reproduction phase
2720. In other examples, more advanced averaging algorithms could
be applied to eliminating high and low values.
[0222] In an example, there may be a safety concern about
automatically increasing the voltage. For example, if there is poor
connection between the device and the user's skin, the voltage may
auto-adjust at 2730 up to the max. The impedance may then be
reduced, for example by the user pressing the device firmly, which
may result in a sudden high current. Therefore, in one example, if
the sample is 500 mv or more higher than the target, it immediately
adjusts to the minimum voltage. This example then remains in
reproduction phase 2720 and should adjust back to the target
current/charge level. In another example, the maximum voltage
increase is set for a single treatment (e.g., 10V). More than that
should not be needed in normal situations to achieve the
established target_charge. In another example, a max is set for
VBOOST (e.g., 80V).
[0223] In various examples, it is desired to have stability during
reproduction phase 2720. In one example, this is accomplished by
adjusting the voltage by steps. However, a relatively large step
adjustment can result in oscillation or over stimulation.
Therefore, voltage adjustments may be made in smaller steps. The
step size may be based on both the delta between the target and
sample current as well as on the actual VBOOST voltage level. This
facilitates a quick and stable/smooth convergence to the target
charge and uses a more gradual adjustments at lower voltages for
more sensitive users.
[0224] The following are the conditions that may be evaluated to
determine the adjustment step.
TABLE-US-00002 delta-mon_current = abs(sample_mon_current -
target_charge) If delta_mon_current > 500mv and VBOOST > 20V
then step = 5V for increase adjustments (For decrease adjustments a
500mv delta triggers emergency decrease to minimum Voltage) If
delta_mon_current > 200mv then step = 1V If delta_mon_current
> 100mv and delta_mon_current > 5% * sample_mon_current then
step = 1V
[0225] In other examples, new treatments are started with voltage
lower than target voltage with a voltage buffer of approximately
10%. The impedance is unknown at the treatment start. These
examples save the target_voltage in use at the end of a treatment.
If the user has not adjusted the strength parameter manually, it
starts a new treatment with saved target_voltage with the 10%
buffer. This achieves target current quickly with the 10% buffer to
avoid possible over stimulation in case impedance has been reduced.
This also compensates for the first 3-4 pulses that are generally
higher.
[0226] As disclosed, examples apply an initial charge level, and
then automatically adjust based on feedback of the amount of
current being applied. The charge amount can be varied up or down
while being applied. Therefore, rather than setting and then
applying a fixed voltage level throughout a treatment cycle,
implementations of the invention measure the amount of charge that
is being input to the user, and adjust accordingly throughout the
treatment to maintain a target charge level that is suitable for
the current environment.
[0227] Location-Specific Patch
[0228] The duration of use and electronic effectiveness of the
Topical Nerve Stimulation and Sensor (TNSS) apparatus as disclosed
in examples herein may be further optimized by form factor
according to specific location of skin application. Examples
include the use of a patch incorporating a TNSS apparatus and
designed in a shape to adhere to a specific location on a person's
body, or in a shape to be incorporated into clothing to be in close
proximity to a specific location on a person's body, to optimize
the effectiveness of the TNSS.
[0229] In FIG. 30, a tibial patch or TNSS or "SmartPad" 100 in
accordance with examples is designed in a shape to conform to the
skin when affixed in the location below the ankle bone 110 to be
effective at stimulating the tibial nerve; and the shape to be of
one type for the left ankle, and of a similar but mirrored type for
the right ankle. A SmartPad is more effective when the positive and
negative electrodes are placed axially along the path of the nerve
in contrast to transversely across the path of the nerve, which is
not as effective.
[0230] In FIG. 31, a radial SmartPad 200 is designed in a shape to
conform to the skin when affixed in the location on the forearm to
be electronically effective at stimulating the radial nerve 202; a
median SmartPad 220 is designed in a shape to conform to the skin
when affixed in the location on the forearm to be electronically
effective at stimulating the median nerve 222; and an ulnar
SmartPad 240 is designed to conform to the skin when affixed in the
location on the forearm to be electronically effective at
stimulating the ulnar nerve 242.
[0231] Each of the SmartPad shapes in FIGS. 30 and 31 is designed
to minimize discomfort for the user when affixed in the target
location.
[0232] In some examples, two or more of the radial 200, median 220
and ulnar SmartPads 240 may be designed into a larger SmartPad with
a shape to cover the locations on the skin corresponding to the two
or more of radial, median and ulnar nerve stimulation electrode
pairs, such as a bracelet shape 250 surrounding the forearm, or a
semi-bracelet 255 spanning one side of the forearm, or a bracelet
shape with strap 260 surrounding the forearm and using a strap 265
to tighten to maintain placement of electrodes without the need for
additional adhesives. In some examples, these combined SmartPads
are designed in one shape for the left forearm, and a similar but
mirrored shape for the right forearm.
[0233] In FIG. 32, a skin patch 300 includes a SmartPad 340 with
TNSS design and packaging disclosed above. SmartPad 340 material is
selected to be disposable after removal from the skin, for example
paper, and is selected to inhibit moisture penetration and foreign
material intrusion which might adversely affect the performance of
the TNSS. SmartPad 340 is packaged before use between top outer
packaging 310, and bottom outer packaging 320. Top outer packaging
incorporates one or more of writing 312, illustrations 314, and
orientation mark 316, the orientation mark 316 being useful for
properly positioning the SmartPad 340 on the skin. Bottom outer
packaging incorporates one or both of writing 322 and illustrations
324. SmartPad 340 may have removable orientation marking 346,
initially affixed to the outer surface of the SmartPad 340, this
marking designed to simplify proper orientation of the SmartPad
onto the target location on the skin and designed to be removed by
the user while leaving the SmartPad in place such that the
distinctive marking 346 is no longer seen on the user's skin.
SmartPad 340 may have supplementary adhesive pads 350 of sufficient
size and efficacy to maintain adhesion when in use but minimize
pulling force when removing the SmartPad 340; and adhesive pad
covers 330, initially covering the supplementary adhesive pads 350
and covering the electrodes, the adhesive pad covers 330 being
removed before affixing the adhesives to the skin; folded pull tabs
332 to facilitate remove of the adhesive film covers 330. SmartPad
340 may have non-adhering tab area 344, at one or both ends of the
SmartPad, to facilitate grabbing of the SmartPad edge to begin
removal of the SmartPad, opposite the adhesive film patches 350.
All components of SmartPad 340 are coupled to the same substrate in
one example.
[0234] FIG. 33 illustrates other example locations for a patch.
[0235] FIG. 34 illustrates a cutaway view where a right foot
plantar sock patch 530 is affixed into the sole 520 of a sock 510,
using adhesive or stitches, such that the sock patch 530 is
effective for stimulation through the sole of the user's foot skin
and tissue to stimulate the plantar nerve.
[0236] In some examples, the sock patch uses a removable battery
power supply. In some examples, the sock patch uses a rechargeable
battery power supply and has a recharging port on the sock. In some
examples, the sock patch uses a battery power supply with kinetic
power converter.
[0237] FIG. 35 illustrates a cutaway view where a right foot
plantar shoe patch 630 is affixed into the sole 625 of a shoe 615,
such that the shoe patch 630 is effective for stimulation through
the sole of the user's foot skin and tissue to stimulate the
plantar nerve, particularly when wearing no intervening clothing
layer such as a sock which reduces the effectiveness of the
stimulation.
[0238] In some examples, shoe patch 630 uses a removable battery
power supply. In some examples, the shoe patch uses a rechargeable
battery power supply and has a recharging port on the shoe. In some
examples, the shoe patch uses a battery power supply with kinetic
power converter. In some examples, shoe patch 630 is incorporated
into the shoe 615 during manufacture of the shoe, the shoe being
specifically designed for a wearer to use the integral TNSS
device.
[0239] In some examples, shoe patch 630 is applied to an interior
surface of an ordinary shoe 610 by the person intending to wear the
shoe.
[0240] Skin patches designed for specific body locations use
different software libraries for their operation, each of which is
optimized for the skin patch location and using a model for the
underlying skin, tissue and nerves. An example is a sacral skin
patch which involves models for the skin, fat, muscle, bone and
nerves specific to the sacrum location, as compared to an ulnar
skin patch which involves models which involves models for the
tibial nerve location.
[0241] Several examples are specifically illustrated and/or
described herein. However, it will be appreciated that
modifications and variations of the disclosed examples are covered
by the above teachings and within the purview of the appended
claims without departing from the spirit and intended scope of the
invention.
* * * * *