U.S. patent application number 17/080544 was filed with the patent office on 2021-04-22 for dry electrodes for transcutaneous nerve stimulation.
The applicant listed for this patent is Cala Health, Inc.. Invention is credited to John Vincent Colombo, Samuel Richard Hamner, Kathryn H. Rosenbluth, Gregory T. Schulte, Serena HanYing Wong.
Application Number | 20210113834 17/080544 |
Document ID | / |
Family ID | 1000005315869 |
Filed Date | 2021-04-22 |
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United States Patent
Application |
20210113834 |
Kind Code |
A1 |
Wong; Serena HanYing ; et
al. |
April 22, 2021 |
DRY ELECTRODES FOR TRANSCUTANEOUS NERVE STIMULATION
Abstract
Disclosed herein are systems, devices, and methods for
peripheral nerve stimulation, particularly for treating tremor. The
nerve stimulation may be accomplished by a wearable nerve
stimulation device, such as a band configured to be worn on the
wrist or other body part. The device can accomplish targeted nerve
stimulation using circumferentially spaced electrodes. In some
embodiments, the device may use only the same number of electrodes
as the number of nerves that are to be stimulated. A biphasic
charge-balanced waveform may be used to selectively stimulate a
nerve near one of the activated electrodes but not to stimulate the
nerve near the other activated electrode. The device may use dry
electrodes for long-term, repeated use. The dry electrodes may
include a conductive base layer and a polymeric, plastic or rubber
skin contact layer comprising a conductive filler. The filler may
be a powder, fiber, conductive coating, etc.
Inventors: |
Wong; Serena HanYing; (Palo
Alto, CA) ; Schulte; Gregory T.; (Oakland, CA)
; Hamner; Samuel Richard; (San Francisco, CA) ;
Rosenbluth; Kathryn H.; (San Francisco, CA) ;
Colombo; John Vincent; (Burlingame, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cala Health, Inc. |
Burlingame |
CA |
US |
|
|
Family ID: |
1000005315869 |
Appl. No.: |
17/080544 |
Filed: |
October 26, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16241846 |
Jan 7, 2019 |
10814130 |
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17080544 |
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PCT/US2017/040920 |
Jul 6, 2017 |
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16241846 |
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62360265 |
Jul 8, 2016 |
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62432519 |
Dec 9, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/681 20130101;
A61N 1/18 20130101; A61N 1/3787 20130101; A61N 1/36025 20130101;
A61N 1/36 20130101; A61N 1/0476 20130101; A61N 1/0484 20130101;
A61N 1/0456 20130101; A61N 1/36031 20170801; A61N 1/36007 20130101;
A61N 1/04 20130101; A61N 1/32 20130101; A61N 1/0492 20130101; A61N
1/36067 20130101; A61N 1/36021 20130101 |
International
Class: |
A61N 1/36 20060101
A61N001/36; A61N 1/04 20060101 A61N001/04; A61N 1/32 20060101
A61N001/32; A61N 1/18 20060101 A61N001/18; A61N 1/378 20060101
A61N001/378 |
Claims
1. A dry electrode for transcutaneous electrical stimulation, the
dry electrode comprising: a conductive backing layer; and a skin
contact layer disposed on the conductive backing layer, the skin
contact layer comprising a polymer, plastic, or rubber material,
and a conductive filler material dispersed substantially evenly
throughout the polymer, plastic, or rubber material, wherein the
skin contact layer has a skin facing surface that is not coated
with a hydrogel or liquid.
2. The dry electrode of claim 1, wherein the conductive backing
layer comprises a metal foil.
3. The dry electrode of claim 2, wherein the metal foil is disposed
on a flexible polymer substrate.
4. The dry electrode of claim 1, wherein the conductive filler
material comprises a powder or fine particulate material.
5. The dry electrode of claim 1, wherein the conductive filler
material comprises metal, carbon, or a mixture thereof.
6. The dry electrode of claim 1, wherein the conductive layer
comprises porous material treated with a conductive coating.
7. The dry electrode of claim 1, wherein the skin contact layer has
a Shore hardness between about 10 A to about 100 A.
8. The dry electrode of claim 1, wherein the skin contact layer has
a volume resistivity between about 1 ohm*cm and about 2000
ohm*cm.
9. The dry electrode of claim 1, wherein the measured resistance or
conductance at a plurality of points across the skin facing surface
of the skin contact layer has a standard deviation of within about
50% of the average measured resistance or conductance.
10. The dry electrode of claim 1, wherein the skin contacting layer
comprises silicone.
11. A dry electrode for transcutaneous electrical stimulation, the
dry electrode comprising: a conductive backing layer; and a skin
contact layer disposed on the conductive backing layer, the skin
contact layer comprising a polymer, plastic, or rubber material,
and a conductive filler material dispersed substantially evenly
throughout the polymer, plastic, or rubber material, wherein the
conductive filler material comprises silver coated glass bubbles or
single wall carbon nanotubes, wherein the skin contact layer has a
skin facing surface that is not coated with a hydrogel or liquid,
wherein the dry electrode has a bulk resistivity of between about
50 ohm-cm and about 1,000 ohm-cm, wherein the skin contact layer
has a Shore A durometer of between about 30 A and about 50 A,
wherein the homogeneity of the conductive filler material is such
that there is less than about a 5% difference in resistivity across
the skin contact layer.
12. The dry electrode of claim 11, wherein the skin contact layer
comprises silicone.
13. The dry electrode of claim 11, wherein the conductive filler
material comprises silver coated glass bubbles.
14. The dry electrode of claim 11, wherein the conductive filler
material comprises single wall carbon nanotubes.
15. The dry electrode of claim 13, wherein the loading of silver
coated glass bubbles is between about 3% and about 30% of the skin
contact layer.
16. The dry electrode of claim 14, wherein the loading of single
wall carbon nanotubes is between about 1% and about 5%.
17. A method of delivering transcutaneous electrical stimulation to
a person, comprising: providing a wearable device comprising at
least 2 dry electrodes comprising a conductive backing layer, and a
skin contact layer comprising a polymer, plastic, or rubber
material and a conductive filler material dispersed substantially
evenly throughout the polymer, plastic, or rubber material, the
skin contact layer further comprising a conductive filler material
dispersed substantially evenly throughout the polymer, plastic, or
rubber material; positioning the skin contact layer of the dry
electrodes on desired locations on the skin, wherein the polymer,
plastic, or rubber material is in direct contact with the skin; and
activating the device, thereby delivering electrical current
through the dry electrodes to the desired locations on the
skin.
18. The method of claim 17, wherein the desired locations are
adjacent one or more target nerves.
Description
INCORPORATION BY REFERENCE
[0001] This application claims the benefit as a continuation of PCT
App. No. PCT/US2017/040920 filed on Jul. 6, 2017, which in turn
claims the benefit as a nonprovisional application under 35 U.S.C.
.sctn. 119(e) of U.S. Prov. App. No. 62/360,265, filed on Jul. 8,
2016, and U.S. Prov. App. No. 62/432,519, filed on Dec. 9, 2016.
Each of the foregoing applications is hereby incorporated by
reference in their entireties. This application also incorporates
by reference in their entireties International Application Number
PCT/US2015/033809, filed Jun. 10, 2016; U.S. Pat. No. 9,452,287
issued on Sep. 27, 2016; International Application No.
PCT/US2016/37080, filed Jun. 10, 2016; International Patent
Application No. PCT/US2015/033809, filed Jun. 2, 2015; U.S.
Application No. 62/173,894, filed Jun. 10, 2015; International
Patent Application No. PCT/US2016/045038 filed on Aug. 1, 2016;
International Patent Application No. PCT/US2016/053513 filed on
Sep. 23, 2016; and International Patent Application No.
PCT/US2017/014431 filed on Jan. 20, 2017.
BACKGROUND
Field of the Invention
[0002] Embodiments of the invention relate generally to systems,
devices, and methods for stimulating nerves, and more specifically
relate to system, devices, and methods for electrically stimulating
peripheral nerve(s) to treat various disorders.
Description of the Related Art
[0003] Electrical stimulation can be delivered transcutaneously via
transcutaneous electrical nerve stimulation (TENS) systems to
stimulate peripheral nerves, such as the median, radial, or ulnar
nerves in the upper extremities, or the tibial, saphenous, or
peroneal nerve in the lower extremities, or the vagus nerve in the
ear or neck. Electrical stimulation of these nerves has been shown
to provide therapeutic benefit across a variety of diseases,
including but not limited to movement disorders (including but not
limited to essential tremor, Parkinson's tremor, orthostatic
tremor, and multiple sclerosis), urological disorders,
gastrointestinal disorders, and cardiac diseases. A number of
conditions, such as tremors, can be treated through some form of
transcutaneous peripheral nerve stimulation.
[0004] Other disorders can also be treated through peripheral nerve
neurostimulation. For example, stimulation of the sacral and/or
tibial nerve has been shown to improve symptoms of overactive
bladder and urinary incontinence, and stimulation of the vagus
nerve has been shown to improve symptoms of hypertension and
cardiac dysrhythmias.
[0005] Some previously described transcutaneous stimulators
describe using multiple electrodes, such as at least three
electrodes, in order to stimulate multiple peripheral nerves, such
as various combinations of the median, radial, and ulnar nerves in
the arm. For example, each nerve can be stimulated with a dedicated
electrode pair, which would require twice the number of electrodes
compared to the number of nerves to be stimulated. For example, to
stimulate both radial and median nerves would require 4 electrodes.
Circumferential electrodes with a dedicated return electrode and
individual electrodes placed over each nerve could also be used.
For example, three circumferentially spaced electrodes can also be
used to stimulate those two nerves, thereby reducing the number of
electrodes by one, to three electrodes.
[0006] It would be desirable to further reduce the number of
electrodes required to stimulate multiple nerves in order to reduce
the size and cost of the stimulation surface or disposable.
[0007] Most commercially available devices that deliver electrical
stimulation transcutaneously utilize a hydrogel electrode to
provide a reliably comfortable stimulation to the wearer (or are a
dry electrode with a conductive gel applied). Hydrogel electrodes
have two beneficial properties that provide uniform current
distribution across the surface of the electrode, which improves
comfort of stimulation: (1) a water or gel based electrode surface
allows for preferable conduction properties electrode, and (2)
adhesion to the skin provides high skin conformance. This
conformance and integrity of the contact can be important in some
cases for comfortable electrical stimulation of sensory nerves
below the skin surface. However, the sticky hydrogel electrode can
potentially provide challenges in usability for the wearer, as the
hydrogel material does not allow movement (e.g., adjustment of a
body-worn device), can be challenging to remove and apply (e.g.,
can lose its adhesive properties), can easily and quickly become
dirty or degrade, especially in real-world environments, and can
cause skin irritation. Thus, hydrogel electrodes may not be
desirable for repeated, all day wear. For these reasons, it can be
advantageous in some embodiments to develop a dry skin interface
between the electrode and skin known as a "dry electrode" to
deliver electrical stimulation, particularly for body-worn
stimulation devices intended for long-term, repeated wear. It can
also be challenging to develop a dry electrode material, because
loading agents that allow for conduction also tend to increase
material stiffness, which reduces conformance and leads to
discomfort at the skin interface. Furthermore, it can in at least
some cases be very difficult to manufacture dry electrodes which
provide uniform field at the skin electrode interface.
SUMMARY
[0008] The present invention relates generally to systems, devices,
and methods for stimulating nerves, and more specifically relate to
system, devices, and methods for electrically stimulating
peripheral nerve(s) to treat various disorders.
[0009] In some embodiments, a system for noninvasively stimulating
at least two peripheral nerves of a patient is provided. The system
can include a first electrode and a second electrode. The first
electrode can be placed against the patient's skin proximate a
first peripheral nerve and the second electrode can be placed
against the patient's skin proximate a second peripheral nerve. The
system further includes a stimulator configured to generate an
electrical stimulation, the stimulator in electrical communication
with the first electrode and the second electrode. The system
further includes a controller configured to control the generation
of the electrical stimulation by the stimulator. The electrical
stimulation can include a first stimulation waveform that is charge
balanced and can have an excitatory phase and a charge balance
phase where the first electrode serves as an excitatory electrode
(e.g., as an anode) and the second electrode serves as a charge
balance electrode (e.g., as a cathode). The system can include
exactly the same number of electrodes as the number of nerves
configured to be stimulated.
[0010] In some embodiments, the excitatory phase of the first
stimulation waveform has the same amplitude and duration as the
charge balance phase of the first stimulation waveform. The first
stimulation waveform is configured to stimulate the first
peripheral nerve and the second peripheral nerve
simultaneously.
[0011] In some embodiments, the excitatory phase of the first
stimulation waveform has a greater amplitude and a shorter duration
than the charge balance phase of the first stimulation waveform.
The first stimulation waveform is configured to stimulate the first
peripheral nerve and not stimulate the second peripheral nerve. The
excitatory phase can have either a positive or negative-going
charge with the charge balance phase have a corresponding opposite
polarity.
[0012] In some embodiments, the system includes no more than two
electrodes.
[0013] In some embodiments, the electrical stimulation generated by
the controller further includes a second stimulation waveform that
is charge balanced and includes an excitatory phase and a charge
balance phase. The polarity of the first electrode and the second
electrode can be switched between the first stimulation waveform
and the second stimulation waveform such that in the second
stimulation waveform the first electrode serves as the charge
balance electrode and the second electrode serves as excitatory
electrode. The excitatory phase of the second stimulation waveform
has a greater amplitude and a shorter duration than the charge
balance phase of the second stimulation waveform. The second
stimulation waveform is configured to stimulate the second
peripheral nerve and not stimulate the first peripheral nerve.
[0014] In some embodiments, the first electrode and second
electrode are disposed on a wearable band.
[0015] In some embodiments, the first electrode and the second
electrode are spaced farther apart than the spacing of the first
nerve and the second nerve such that when placed on skin, the first
electrode and the second electrode flank the first nerve and the
second nerve.
[0016] In some embodiments, the first electrode and the second
electrode are spaced apart less than the spacing of the first nerve
and the second nerve such that when placed on skin, the first nerve
and the second nerve flank the first electrode and the second
electrode.
[0017] In some embodiments, the amplitude of the excitatory phase
of the first stimulation waveform is about or at least about 2, 3,
4, 5, 6, 7, 8, 9, 10, 15, 20, or more times greater than the
amplitude of the charge balance phase of the first stimulation
waveform, or within a range incorporating any two of the
aforementioned values.
[0018] In some embodiments, the amplitude of the excitatory phase
of the first stimulation waveform is less than about 20, 15, 10, 9,
8, 7, 6, 5, 4, 3, 2 times or less greater than the amplitude of the
charge balance phase of the first stimulation waveform.
[0019] In some embodiments, the first electrode is spaced apart
from the second electrode based on the spacing between the first
nerve and the second nerve.
[0020] In some embodiments, the first electrode is spaced apart
from the second electrode based additionally on the depths of the
first nerve and second nerve.
[0021] In some embodiments, the number of electrodes equals the
number of nerves to be stimulated.
[0022] In some embodiments, the system further includes one or more
additional electrodes. Each additional electrode is placed over a
peripheral nerve, and the controller is configured to select one of
the electrodes as the excitatory electrode and one of the other
electrodes as the charge balance electrode. The selection of the
excitatory electrode is based on the peripheral nerve to be
stimulated.
[0023] In some embodiments, the selection of the charge balance
electrode is based in part on the spacing between the excitatory
electrode and the charge balance electrode.
[0024] In some embodiments, the first electrode and the second
electrodes are dry electrodes including a conductive backing layer
and a skin contact layer disposed on the conductive backing layer.
The skin contact layer includes a polymer, plastic, or rubber
material, and a conductive filler material dispersed substantially
evenly throughout the polymer, plastic, or rubber material. The
skin contact layer has a skin facing surface that is not coated
with a hydrogel or liquid.
[0025] In some embodiments, the conductive backing layer of the dry
electrodes may include a metal foil. The metal foil may be disposed
on a flexible polymer substrate. The conductive filler material may
include a powder or fine particulate material. The conductive
filler material may include metal, carbon, or a mixture thereof.
The conductive layer can include a porous material treated with a
conductive coating. The skin contact layer may have a Shore
hardness between about 10 A to about 100 A. The skin contact layer
may have a volume resistivity between about 1 ohm*cm and about 2000
ohm*cm. The measured resistance or conductance at a plurality of
points across the skin facing surface of the skin contact layer may
have a standard deviation of within about 50% of the average
measured resistance or conductance. The skin contacting layer may
comprise silicone. The conductive filler material may include
silver coated glass bubbles or single wall carbon nanotubes,
wherein the homogeneity of the conductive filler material is such
that there is less than about a 5% difference in resistivity across
the skin contact layer. The conductive filler material may include
silver coated glass bubbles. The conductive filler material may
include single wall carbon nanotubes. The loading of silver coated
glass bubbles may be between about 3% and about 30% of the skin
contact layer. The loading of single wall carbon nanotubes may be
between about 1% and about 5%. The skin contact layer may have a
Shore hardness between about 25 A to about 55 A. The skin contact
layer may have a volume resistivity between about 50 ohm*cm and
about 1000 ohm*cm.
[0026] In some embodiments, a system for noninvasively stimulating
at least two peripheral nerves of a patient is provided. The system
includes a first electrode and a second electrode, wherein the
first electrode is configured to be placed against the patient's
skin proximate a first peripheral nerve and the second electrode is
configured to be placed against the patient's skin proximate a
second peripheral nerve. The system further includes a stimulator
configured to generate an electrical stimulation. The stimulator is
in electrical communication with the first electrode and the second
electrode. The system further includes a controller configured to
control the generation of the electrical stimulation by the
stimulator. The electrical stimulation includes a first stimulation
waveform that is charge balanced and comprises an excitatory phase
and a charge balance phase where the first electrode serves as an
excitatory electrode and the second electrode serves as a charge
balance electrode. The excitatory phase of the first stimulation
waveform has a greater amplitude and a shorter duration than the
charge balance phase of the first stimulation waveform. The first
stimulation waveform is configured to stimulate the first
peripheral nerve and not stimulate the second peripheral nerve.
[0027] In some embodiments, the system may include no more than two
electrodes. The electrical stimulation generated by the controller
may further include a second stimulation waveform that is charge
balanced and comprises a excitatory phase and a charge balance
phase. The polarity of the first electrode and the second electrode
may be switched between the first stimulation waveform and the
second stimulation waveform such that in the second stimulation
waveform the first electrode serves as the charge balance electrode
and the second electrode serves as excitatory electrode. The
excitatory phase of the second stimulation waveform may have a
greater amplitude and a shorter duration than the charge balance
phase of the second stimulation waveform. The second stimulation
waveform may be configured to stimulate the second peripheral nerve
and not stimulate the first peripheral nerve.
[0028] In some embodiments, the first electrode and second
electrode may be disposed on a wearable band. The first electrode
and the second electrode may be spaced farther apart than the
spacing of the first nerve and the second nerve such that when
placed on skin, the first electrode and the second electrode flank
the first nerve and the second nerve. The first electrode and the
second electrode may be spaced apart less than the spacing of the
first nerve and the second nerve such that when placed on skin, the
first nerve and the second nerve flank the first electrode and the
second electrode. The amplitude of the excitatory phase of the
first stimulation waveform may be at least about 4 times greater
than the amplitude of the charge balance phase of the first
stimulation waveform. The amplitude of the excitatory phase of the
first stimulation waveform may be less than about 10 times greater
than the amplitude of the charge balance phase of the first
stimulation waveform. The first electrode may be spaced apart from
the second electrode based on the spacing between the first nerve
and the second nerve. The first electrode may be spaced apart from
the second electrode based additionally on the depths of the first
nerve and second nerve. The number of electrodes can equal the
number of nerves to be stimulated. The system may further include
one or more additional electrodes, wherein each additional
electrode is placed over a peripheral nerve. The controller can be
configured to select one of the electrodes as the excitatory
electrode and one of the other electrodes as the charge balance
electrode, wherein the selection of the excitatory electrode may be
based on the peripheral nerve to be stimulated. The selection of
the charge balance electrode may be based in part on the spacing
between the excitatory electrode and the charge balance
electrode.
[0029] In some embodiments, a method for noninvasively stimulating
a plurality of peripheral nerves of a patient with exactly one
electrode per each peripheral nerve stimulated is disclosed. The
method includes positioning a first electrode against the patient's
skin proximate a first peripheral nerve; positioning a second
electrode against the patient's skin proximate a second peripheral
nerve; and delivering a first electrical stimulation through the
first electrode to stimulate the first peripheral nerve. The first
electrical stimulation includes a first stimulation waveform that
is charge balanced and comprises an excitatory phase and a charge
balance phase. During the first electrical stimulation, the first
electrode serves as an excitatory electrode and the second
electrode serves as a charge balance electrode. The excitatory
phase of the first stimulation waveform has a greater amplitude and
a shorter duration than the charge balance phase of the first
stimulation waveform. The first stimulation waveform is configured
to stimulate the first peripheral nerve and not stimulate the
second peripheral nerve.
[0030] In some embodiments, the method further includes delivering
a second electrical stimulation through the second electrode to
stimulate the second peripheral nerve. The second electrical
stimulation includes a second stimulation waveform that is charge
balanced and includes an excitatory phase and a charge balance
phase. During the second electrical stimulation, the second
electrode serves as an excitatory electrode and the first electrode
serves as a charge balance electrode. The excitatory phase of the
second stimulation waveform has a greater amplitude and a shorter
duration than the charge balance phase of the second stimulation
waveform. The second stimulation waveform is configured to
stimulate the second peripheral nerve and not stimulate the first
peripheral nerve.
[0031] In some embodiments, the first electrode and second
electrode may be disposed on a wearable band. The first electrode
and the second electrode may be spaced farther apart than the
spacing of the first nerve and the second nerve such that when
placed on skin, the first electrode and the second electrode flank
the first nerve and the second nerve. The first electrode and the
second electrode may be spaced apart less than the spacing of the
first nerve and the second nerve such that when placed on skin, the
first nerve and the second nerve flank the first electrode and the
second electrode. The amplitude of the excitatory phase of the
first stimulation waveform may be at least about 4 times greater
than the amplitude of the charge balance phase of the first
stimulation waveform. The amplitude of the excitatory phase of the
first stimulation waveform may be less than about 10 times greater
than the amplitude of the charge balance phase of the first
stimulation waveform. The first electrode may be spaced apart from
the second electrode based on the spacing between the first nerve
and the second nerve. The first electrode may be spaced apart from
the second electrode based additionally on the depths of the first
nerve and second nerve. The first nerve may be selected from the
group consisting of the ulnar nerve, the radial nerve, and the
median nerve. The second nerve may be selected from the group
consisting of the ulnar nerve, the radial nerve, and the median
nerve, wherein the second nerve is a different nerve from the first
nerve. The first nerve may be selected from the group consisting of
the pudendal nerve, pelvic nerve, tibial nerve, medial plantar
nerve, lateral plantar nerve, calcaneal nerve, and saphenous nerve.
The second nerve may be selected from the group consisting of the
pudendal nerve, pelvic nerve, tibial nerve, medial plantar nerve,
lateral plantar nerve, calcaneal nerve, and saphenous nerve,
wherein the second nerve is a different nerve from the first
nerve.
[0032] In some embodiments, a method for noninvasively stimulating
a plurality of peripheral nerves of a patient with exactly one
electrode per each peripheral nerve stimulated is provided. The
method includes positioning a first electrode against the patient's
skin proximate a first peripheral nerve; positioning a second
electrode against the patient's skin proximate a second peripheral
nerve; and delivering a first electrical stimulation through the
first electrode to stimulate the first peripheral nerve. The first
electrical stimulation includes a first stimulation waveform that
is charge balanced and comprises an excitatory phase and a charge
balance phase. During the first electrical stimulation the first
electrode serves as an excitatory electrode and the second
electrode serves as a charge balance electrode. The first
stimulation waveform is configured to stimulate the first
peripheral nerve and the second peripheral nerve
simultaneously.
[0033] In some embodiments, the excitatory phase of the first
stimulation waveform may have the same amplitude and duration as
the charge balance phase of the first stimulation waveform. The
first electrode and second electrode may be disposed on a wearable
band. The first electrode and the second electrode may be spaced
farther apart than the spacing of the first nerve and the second
nerve such that when placed on skin, the first electrode and the
second electrode flank the first nerve and the second nerve. The
first electrode and the second electrode may be spaced apart less
than the spacing of the first nerve and the second nerve such that
when placed on skin, the first nerve and the second nerve flank the
first electrode and the second electrode. The first electrode may
be spaced apart from the second electrode based on the spacing
between the first nerve and the second nerve. The first electrode
may be spaced apart from the second electrode based additionally on
the depths of the first nerve and second nerve. The first nerve may
be selected from the group consisting of the ulnar nerve, the
radial nerve, and the median nerve. The second nerve may be
selected from the group consisting of the ulnar nerve, the radial
nerve, and the median nerve, wherein the second nerve is a
different nerve from the first nerve. The first nerve may be
selected from the group consisting of the pudendal nerve, pelvic
nerve, tibial nerve, medial plantar nerve, lateral plantar nerve,
calcaneal nerve, and saphenous nerve. The second nerve may be
selected from the group consisting of the pudendal nerve, pelvic
nerve, tibial nerve, medial plantar nerve, lateral plantar nerve,
calcaneal nerve, and saphenous nerve, wherein the second nerve is a
different nerve from the first nerve.
[0034] In some embodiments, a system for noninvasively stimulating
at least two peripheral nerves of a patient is provided. The system
includes a first electrode and a second electrode, wherein the
first electrode is configured to be placed against the patient's
skin proximate a first peripheral nerve and the second electrode is
configured to be placed against the patient's skin proximate a
second peripheral nerve. The system further includes a stimulator
configured to generate an electrical stimulation. The stimulator is
in electrical communication with the first electrode and the second
electrode. The system further includes a controller configured to
control the generation of the electrical stimulation by the
stimulator. The electrical stimulation includes a first stimulation
waveform that is charge balanced and comprises an excitatory phase
and a charge balance phase. The first electrode serves as an
excitatory electrode and the second electrode serves as a charge
balance electrode. The system comprises exactly the same number of
electrodes as the number of nerves configured to be stimulated.
[0035] In some embodiments, the excitatory phase of the first
stimulation waveform may have the same amplitude and duration as
the charge balance phase of the first stimulation waveform. The
first stimulation waveform may be configured to stimulate the first
peripheral nerve and the second peripheral nerve simultaneously.
The excitatory phase of the first stimulation waveform may have a
greater amplitude and a shorter duration than the charge balance
phase of the first stimulation waveform. The first stimulation
waveform may be configured to stimulate the first peripheral nerve
and not stimulate the second peripheral nerve.
[0036] In some embodiments, the electrical stimulation generated by
the controller may further include a second stimulation waveform
that is charge balanced and includes an excitatory phase and a
charge balance phase. The polarity of the first electrode and the
second electrode can be switched between the first stimulation
waveform and the second stimulation waveform such that in the
second stimulation waveform the first electrode serves as the
charge balance electrode and the second electrode serves as
excitatory electrode. The excitatory phase of the second
stimulation waveform may have a greater amplitude and a shorter
duration than the charge balance phase of the second stimulation
waveform. The second stimulation waveform may be configured to
stimulate the second peripheral nerve and not stimulate the first
peripheral nerve.
[0037] In some embodiments, the first electrode and second
electrode may be disposed on a wearable band. The first electrode
and the second electrode may be spaced farther apart than the
spacing of the first nerve and the second nerve such that when
placed on skin, the first electrode and the second electrode flank
the first nerve and the second nerve. The first electrode and the
second electrode may be spaced apart less than the spacing of the
first nerve and the second nerve such that when placed on skin, the
first nerve and the second nerve flank the first electrode and the
second electrode. The amplitude of the excitatory phase of the
first stimulation waveform may be at least about 4 times greater
than the amplitude of the charge balance phase of the first
stimulation waveform. The amplitude of the excitatory phase of the
first stimulation waveform may be less than about 10 times greater
than the amplitude of the charge balance phase of the first
stimulation waveform. The first electrode may be spaced apart from
the second electrode based on the spacing between the first nerve
and the second nerve. The first electrode may be spaced apart from
the second electrode based additionally on the depths of the first
nerve and second nerve.
[0038] In some embodiments, the first electrode and the second
electrodes can be dry electrodes including a conductive backing
layer and a skin contact layer disposed on the conductive backing
layer. The skin contact layer may include a polymer, plastic, or
rubber material, and a conductive filler material dispersed
substantially evenly throughout the polymer, plastic, or rubber
material. The skin contact layer may have a skin facing surface
that is not coated with a hydrogel or liquid. The conductive
backing layer of the dry electrodes may include a metal foil. The
metal foil may be disposed on a flexible polymer substrate. The
conductive filler material may include a powder or fine particulate
material. The conductive filler material may include metal, carbon,
or a mixture thereof. The conductive layer may include a porous
material treated with a conductive coating.
[0039] In some embodiments, the skin contact layer may have a Shore
hardness between about 10 A to about 100 A. The skin contact layer
may have a volume resistivity between about 1 ohm*cm and about 2000
ohm*cm. The measured resistance or conductance at a plurality of
points across the skin facing surface of the skin contact layer may
have a standard deviation of within about 50% of the average
measured resistance or conductance. The skin contacting layer may
include silicone. The conductive filler material may include silver
coated glass bubbles or single wall carbon nanotubes. The
homogeneity of the conductive filler material may be such that
there is less than about a 5% difference in resistivity across the
skin contact layer. The loading of silver coated glass bubbles may
be between about 3% and about 30% of the skin contact layer. The
loading of single wall carbon nanotubes may be between about 1% and
about 5%. In some embodiments, the skin contact layer may have a
Shore hardness between about 25 A to about 55 A. The skin contact
layer may have a volume resistivity between about 50 ohm*cm and
about 1000 ohm*cm.
[0040] In some embodiments, a dry electrode for transcutaneous
electrical stimulation is provided. The dry electrode includes a
conductive backing layer and a skin contact layer disposed on the
conductive backing layer. The skin contact layer includes a
polymer, plastic, or rubber material, and a conductive filler
material dispersed substantially evenly throughout the polymer,
plastic, or rubber material. The skin contact layer has a skin
facing surface that is not coated with a hydrogel or liquid.
[0041] In some embodiments, the conductive backing layer may
include a metal foil. The metal foil may be disposed on a flexible
polymer substrate. The conductive filler material may include a
powder or fine particulate material. The conductive filler material
may include metal, carbon, or a mixture thereof. The conductive
layer may include a porous material treated with a conductive
coating. The skin contact layer may have a Shore hardness between
about 10 A to about 100 A. The skin contact layer may have a volume
resistivity between about 1 ohm*cm and about 2000 ohm*cm. The
measured resistance or conductance at a plurality of points across
the skin facing surface of the skin contact layer may have a
standard deviation of within about 50% of the average measured
resistance or conductance. The skin contacting layer may include
silicone.
[0042] In some embodiments, a wearable band for an electrical
device that can be worn by a person is provided. The band includes
a strap configured to be worn around a body part, at least two dry
electrodes disposed on the strap, a flexible circuit disposed
within the strap, and an electrical connect feature. The dry
electrodes include a polymer, plastic, or rubber material, and a
conductive filler material dispersed substantially evenly
throughout the polymer, plastic, or rubber material. The flexible
circuit is in electrical communication with the at least two dry
electrodes. The electrical connect feature is in electrical
communication with the flex circuit and configured to electrically
connect the flex circuit with the electrical device.
[0043] In some embodiments, the strap includes an elastic portion
configured to apply tension or pressure to the at least two dry
electrodes against the skin when the strap is tightened around the
body part. The strap may include a hook and loop fastener. The
electrical connect feature may be a tab that is an extension of the
flex circuit. The electrical device may be an electrical nerve
stimulation device. The electrical nerve stimulation device can be
programmed to deliver electrical stimulation through the dry
electrodes to treat tremor. The polymer, plastic, or rubber
material may include silicone.
[0044] In some embodiments, a dry electrode for transcutaneous
electrical stimulation is provided. The dry electrode includes a
conductive backing layer and a skin contact layer disposed on the
conductive backing layer. The skin contact layer includes a
polymer, plastic, or rubber material, and a conductive filler
material dispersed substantially evenly throughout the polymer,
plastic, or rubber material. The conductive filler material
includes silver coated glass bubbles or single wall carbon
nanotubes. The skin contact layer has a skin facing surface that is
not coated with a hydrogel or liquid. The dry electrode has a bulk
resistivity of between about 50 ohm-cm and about 1,000 ohm-cm. The
skin contact layer has a Shore A durometer of between about 30 A
and about 50 A. The homogeneity of the conductive filler material
is such that there is less than about a 5% difference in
resistivity across the skin contact layer.
[0045] In some embodiments, the skin contact layer may include
silicone. The conductive filler material may include silver coated
glass bubbles. The conductive filler material may include single
wall carbon nanotubes. The loading of silver coated glass bubbles
may be between about 3% and about 30% of the skin contact layer.
The loading of single wall carbon nanotubes may be between about 1%
and about 5%.
[0046] In some embodiments, a method of delivering transcutaneous
electrical stimulation to a person is provided. The method includes
providing a wearable device comprising at least 2 dry electrodes.
The dry electrodes include a conductive backing layer and a skin
contact layer. The skin contact layer includes a polymer, plastic,
or rubber material and a conductive filler material dispersed
substantially evenly throughout the polymer, plastic, or rubber
material. The skin contact layer further includes a conductive
filler material dispersed substantially evenly throughout the
polymer, plastic, or rubber material. The method further includes
positioning the skin contact layer of the dry electrodes on desired
locations on the skin, wherein the polymer, plastic, or rubber
material is in direct contact with the skin, and activating the
device. Activation of the device delivers electrical current
through the dry electrodes to the desired locations on the skin.
The desired locations may be adjacent one or more target
nerves.
BRIEF DESCRIPTION OF THE DRAWINGS
[0047] A better understanding of the features and advantages of
some embodiments of the present invention will be obtained by
reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings of which:
[0048] FIGS. 1A-IE illustrate various views of an embodiment of a
device and system that provides peripheral nerve stimulation,
targeting individual nerves, to reduce tremor. FIGS. 1A-ID show
multi-perspective views of the device. FIG. 1E shows a schematic of
a housing of the device that contains various electronic
components.
[0049] FIGS. 2A-2C illustrate various embodiments of electrodes on
a wrist, including a charge-balance electrode on the back of the
wrist to reduce the number of electrodes needed to stimulate
multiple nerves and electrodes positioned on the circumference of
the wrist to selectively stimulate the nerves targeted for
excitation.
[0050] FIGS. 3A and 3B illustrate how in some embodiments the band
width can vary depending on how the electrodes are arranged. FIG.
3A illustrates that if the electrodes are placed along the
circumference with a charge-balance electrode, the band width
decreases. FIG. 3B illustrates that in line placement increases the
size of the wrist banded needed.
[0051] FIGS. 4A-4D illustrate various two electrode placements that
can be used to independently stimulate two nerves.
[0052] FIGS. 5A-5G illustrate various charge balanced waveforms and
schematics of electrode configurations that can be used to
stimulate a nerve.
[0053] FIGS. 6A-6B illustrate various schemes for nerve stimulation
at multiple sites. FIG. 6A is a diagram showing an embodiment of an
excitation scheme to dephase the brain regions receiving sensory
input from sites, such as two nerves. FIG. 6B is a diagram showing
an embodiment of an excitation scheme to dephase the brain regions
receiving sensory input from four sites.
[0054] FIGS. 7 and 8 illustrate various embodiments of a wearable
band with two electrodes.
[0055] FIGS. 9A-9H illustrate various embodiments of dry
electrodes.
[0056] FIGS. 10A-10C illustrate views of mechanical elements, such
as holes, that can allow the skin contact layer to surround the
base layer and maintain good contact.
[0057] FIG. 10D illustrates a star-shaped dry electrode, according
to some embodiments of the invention.
[0058] FIG. 10E illustrates schematically a cross-section of a dry
electrode with a variable filler concentration.
[0059] FIGS. 11A-11B illustrate views of electrode geometries with
non-sharp edges and corners.
[0060] FIGS. 12A-12B illustrate electrode testing devices. FIG. 12A
illustrates a testing device for assessing dry electrodes for
consistency and uniformity. FIG. 12B illustrates a device for
testing the impedance of a dry electrode configuration.
[0061] FIGS. 13A-13B illustrate various non-limiting ways dry
electrodes can be attached to a wearable band.
[0062] FIGS. 14A-14F illustrate multi-perspective views of an
embodiment of a band with dry electrodes that can be attached to or
retrofitted to an electrical device, such as a TENS device.
[0063] FIGS. 15A-15D illustrate an exploded view of the various
layers and components of an embodiment of a band with dry
electrodes.
[0064] FIGS. 16A-16F illustrate the steps for an embodiment of a
method of assembling the band shown in FIGS. 15A-15D.
[0065] FIGS. 17A-17B depict results of treating tremor with nerve
stimulation using a wearable device. FIG. 17A illustrates a graph
showing a reduction in tremor for a patient with a customized
stimulation from an embodiment using an array of electrodes. FIG.
17B demonstrates the improvement in a spiral drawn by a patient
before stimulation (at left) and after stimulation (at right).
[0066] FIGS. 18A-18F depict a wearable band and user feedback
regarding the comfort of using the band for nerve stimulation. FIG.
18A illustrates examples of an embodiment of a wearable band with
two dry electrodes and an adjustable strap. FIGS. 18B-18F are
graphs that illustrate that stimulation using the wearable band of
FIG. 18A is comfortable to most wearers.
DETAILED DESCRIPTION
Peripheral Nerve Stimulation Devices and Methods
[0067] One aspect of the invention, according to some embodiments,
is a device and system that provides peripheral nerve stimulation,
targeting individual nerves. FIGS. 1A-1E illustrate an embodiment
of a device and system 10 that allows customization and
optimization of transcutaneous electrical treatment provided to an
individual. In particular, the device 10 described is for
electrical stimulation of two or more nerves. For example, a two
electrode embodiment can be used to stimulate any two of the
median, radial, or ulnar nerves in the wrist or fingers for
treating tremors. Peripheral nerves in other limbs such as the legs
and ankles can also be targeted, as well as peripheral nerves in
the torso and back. Targeting those specific nerves while utilizing
appropriately customized stimulation can result in more effective
therapy (e.g., reduction or prevention of tremor, incontinence or
overactive bladder symptoms, arrhythmias, normalization of blood
pressure, etc.).
[0068] FIGS. 1A-1E illustrate an embodiment of a device and system
10 that provides peripheral nerve stimulation, targeting individual
nerves, to reduce tremor. In some embodiments, the device 10 is
designed to be worn on the wrist, arm, finger, leg, or ankle and is
formed from a housing 12 and a band 14. FIG. 1A illustrates a top
view of the device 10 with the band 14 in an unstrapped
configuration. FIG. 1B illustrates a top view of the device 10 with
the band 14 in a strapped configuration, as if being worn around
the wrist of a user. FIG. 1C illustrates a perspective view of the
device 10 with the band 14 in an unstrapped configuration. FIG. 1D
illustrates a side cross-section of the device 10 with the band 14
in a strapped configuration. FIG. 1E schematically depicts the
operative connections of various electronic components that may be
housed in the device 10. In some embodiments, electronics are
located in a housing 12. The electronics may have sensors to
measure motion, heart rate, and/or skin conduction, and/or generate
an electrical stimulation waveform. The electronics can include a
pulse generator 18 for generating nerve stimulation pulses, a
controller 22 for executing instructions, one or more sensors 20
such as an accelerometer and/or gyroscope for monitoring motion, a
communication module 28 for transmitting data between the device 10
and an external computer or processor (e.g., wirelessly), a user
interface 26 which can include a display and/or buttons for
allowing user operation of the device 10 and for presenting
information, memory 24 for storing data (e.g., instructions,
stimulation protocols, and/or tremor measurements), a battery 30
which may be rechargeable for powering the device 10, and/or an
optional inductive coil 30 for wirelessly charging the battery 30.
Electrical contacts and/or traces in the band 14 and/or housing 12
can transmit the stimulation waveform from the pulse generator 18
to the electrodes 16, which can be disposable. The locations of the
contacts in the band 12 can be arranged such that specific nerves
may be targeted, such as the median and radial nerves in the wrist.
The housing 12 also can have a digital display screen to provide
feedback about the stimulation, measured data, and history to the
wearer of the device 10.
[0069] In some embodiments, the treatment device 10 is a wearable
device including 1) an electronics box or housing 12 containing the
stimulator or pulse generator 18, sensors 20, and other associated
electronics, 2) a band 14 to hold all the components together and
securely fasten the device around the wrist or other body part of
an individual, and 3) a plurality of electrodes 16 (e.g., two
electrodes, three electrodes, etc.) positioned on the inner surface
of the band 14.
Circumferentially Spaced Electrodes
[0070] One aspect of the device, as schematically illustrated in
FIGS. 2A-2C, is the use of only three electrodes to electrically
stimulate two nerves (e.g., median and radial), with an electrode
302, 304 placed on the skin over or proximate to each one of the
two nerves 306, 308 and a third charge balance electrode 300 placed
on an opposite side of the body part (e.g., wrist) as the two
nerves 306, 308. FIG. 2A shows the dorsal side (left) and ventral
side (right) of a user's wrist and illustrates an example of the
placement of the three electrodes 300, 302, 304 on the user's wrist
for targeting two nerves. The three electrodes 300, 302, 304 may
all be operatively connected to a single controller 301, as
schematically illustrated in FIG. 2A, for regulating the targeted
stimulation of the nerves. In some embodiments, the third electrode
300 (e.g., a charge balance electrode) can be placed approximately
on the longitudinal midline of the dorsal side of the arm or wrist.
In some embodiments, the first electrode 302 can be placed
approximately on the longitudinal midline of the ventral side of
the arm or wrist to target the median nerve. In some embodiments,
the second electrode 304 can be placed in between the charge
balance electrode 300 and the ventrally placed electrode 302 to
target the radial nerve. In some embodiments, yet another electrode
(not shown) can be placed to target the ulnar nerve or an electrode
targeting the ulnar nerve can replace either the first electrode
302 targeting the median nerve 306 or the second electrode 304
targeting the radial nerve 308.
[0071] FIGS. 2B and 2C illustrate the positions of the charge
balance electrode 300, the ventrally placed electrode 302, and the
radial electrode 304 in relation to the median nerve 206 and the
radial nerve 208 in a distal-looking transverse cross-sectional
plane of the patient's wrist or arm. The electrodes 200, 202, 204
are positioned such that in a projection into the transverse
cross-sectional plane of the arm or wrist there is a 90 degree to
180 degree angle, al, between a line connecting the median nerve
306 and the center of the charge balance electrode 300 and a line
connecting the median nerve 306 and the center of the ventrally
placed electrode 303, and there is a 90 degree to 180 degree angle,
.alpha.2, between a line connecting the radial nerve 308 and the
charge balance electrode 300 and a line connecting the radial nerve
308 and the radial electrode 304. The angles .alpha.1 and .alpha.2
may each be measured in either a counter-clockwise direction (as
.alpha.1 is shown in FIG. 2B) or in a clockwise direction (as
.alpha.1 is shown in FIG. 2C). More generally, the electrodes 300,
302, 304 can be spaced apart by a predetermined distance such that
when the electrodes 300, 302, 304 are positioned circumferentially
around a patient's wrist, one of the angles formed between each
electrode pair and its target nerve is between about 90 degrees and
180 degrees. Such an orientation results in each electrode of the
electrode pair being placed generally on opposite sides of the
target nerve. In other words, the target nerve is positioned
approximately between the electrode pair.
[0072] FIG. 3A schematically illustrates the placement of three
electrodes 400, 402, 404 for targeted stimulation of two nerves, as
described above. FIG. 3B schematically illustrates the traditional
placement of two electrodes 400', 402' for targeting each of the
same two nerves for a total of four electrodes. As shown in
comparison of FIGS. 3A and 3B, three electrodes 400, 402, 404
placed circumferentially around the wrist allow: (1) a reduced band
width compared to a typical arrangement where the two electrodes
400', 402' are longitudinally placed along the same nerve, and (2)
targeting deeper into the tissue by having the pair of electrodes
positioned across from each other to target each nerve compared to
a typical arrangement where the two electrodes 400', 402' are
positioned on the same side of the arm relative to the targeted
nerve. Although the embodiments have been described with reference
to three electrodes for the stimulation of two nerves, it is
understood that alternative embodiments can utilize two electrodes
to stimulate a single nerve, where the two electrodes can have a
fixed spacing to allow the electrodes to stimulate the nerve from
opposing sides of the nerve. Similarly, other embodiments can
utilize more than three electrodes. For instance, an additional
electrode can be added to target the ulnar nerve. In some
embodiments, five or more electrodes may be used to target four or
more nerves. In addition, different combination of electrodes can
be used to target one or more nerves from the group of the median,
radial, and ulnar nerves.
[0073] Mapping the nerves of a number of individuals with different
wrist sizes was performed by selectively stimulating
circumferential locations on the wrist and verifying where the user
feels paresthesia in order to identify the median, radial, and
ulnar nerve. The mapping showed variability in nerve location
relative to wrist size, as well as high individual variability in
physiology. Individual nerves can be targeted with electrodes
positioned at the correct location, such as the positions shown in
FIG. 2A, or by using an array of multiple electrodes allowing
selection of electrodes which target those individual nerves, as
discussed elsewhere herein.
N Electrode Stimulator to Stimulate N Nerves
[0074] In some embodiments, a stimulator with N electrodes (e.g.,
where N is an integer greater than 1, e.g., 2 or at least 2
electrodes) can be used to stimulate exactly N nerves (e.g., where
N is an integer greater than 1, e.g., 2 or at least 2 electrodes)
either simultaneously or in an alternating pattern to treat various
disorders such as, for example, tremor, overactive bladder,
hypertension, arrhythmias, and other conditions. For example, in
some embodiments, two nerves, such as the median and radial nerves,
can be stimulated using exactly two electrodes, rather than the
three or more electrodes as described above and as described in
International Application Number PCT/US2015/033809 (International
Publication Number WO2015/187712) and U.S. patent application Ser.
No. 14/805,385 (U.S. Application Publication No. 2015/0321000),
which are each incorporated by reference in their entireties. In
other embodiments, exactly 3 nerves can be stimulated by exactly 3
electrodes, exactly 4 nerves can be stimulated by exactly 4
electrodes, etc. Reducing the number of electrodes to be the
exactly the same as the number of nerves to be stimulated (e.g.,
two electrodes to stimulate two nerves) can reduce both
manufacturing costs and electrode installation time while
increasing the durability and/or robustness of the device, which in
some embodiments may need to be utilized on a regular basis, such
as daily. There can also be an improvement in comfort because there
are only, e.g., two contact points instead of three for stimulating
two distinct nerves. The reduced number of electrodes also could
allow integration with other wearable devices (e.g., a smart watch
display) by not requiring a third electrode under the watch face on
the dorsal side of the wrist. Furthermore, in some embodiments,
configurations with a lower number of electrodes required (e.g.,
exactly two electrodes corresponding to exactly two nerves) can
employ unique stimulation patterns/waveforms that stimulate a first
nerve but not a second nerve.
[0075] In some embodiments, the two electrodes, e.g., exactly and
no more than two electrodes may be placed on a band that can be
worn around a body part such as a wrist, ankle, arm, or leg, for
example, in order to excite, for example, the median, radial,
and/or ulnar nerves or the tibial, trigeminal, saphenous and/or
fibular nerves, and/or other peripheral nerves. As shown in FIGS.
4A-4D, the two electrodes, a first electrode 400 and a second
electrode 402 (but no additional electrodes in some embodiments),
can be spaced apart and located on the band such that when worn,
each electrode is positioned on the skin over or proximate to a
target nerve 404, 406. In some embodiments, as shown in FIG. 4A,
the electrodes 400, 402 can be placed on the skin such that the
electrodes are as close as possible to the target nerves 404, 406.
In some embodiments, as shown in FIG. 4B, the electrodes 400, 402
can be spaced wider apart to flank the two nerves 404, 406 such
that the two nerves 404, 406 are positioned between the two
electrodes 400, 402. In some embodiments, as shown in FIG. 4C, the
electrodes 400, 402 can be spaced more narrowly than the two nerves
404, 406 such that the electrodes 400, 402 are positioned between
the two nerves 404, 406. In some embodiments, as shown in FIG. 4D,
the electrodes 400, 402 can be positioned such that the two nerves
404, 406 fall approximately on a straight line drawn between the
two electrodes 400, 402. In other embodiments, combinations of the
electrode spacing described above relative to each nerve may be
employed (e.g., the electrodes 400, 402 and nerves 404, 406 may be
staggered).
[0076] In some embodiments, the spacing of the electrodes depends
in part on the spacing between the nerves to be stimulated and/or
the depth of the nerves beneath the skin because the spacing
between the electrodes affects the depth the generated electrical
field can reach. Generally, the further apart the electrodes (of
opposite polarity) are placed, the deeper the electrical field will
penetrate. The spacing may also be based on the circumference of
the limb or body part and the positioning or location of the target
nerves within the limb or body part. In some embodiments, the
electrodes can be positioned on the same limb or body part of the
subject to be treated, and in some cases spaced apart by a distance
of within about 50 cm, 45 cm, 40 cm, 35 cm, 30 cm, 25 cm, 20 cm, 15
cm, 10 cm, 5 cm, 4 cm, 3 cm, 2 cm, or less.
[0077] There can be a balance between the width and spacing of the
electrodes on the one hand and the circumference of the limb and
spacing of the nerves being treated on the other hand. This has an
effect on the sizing of the electrodes and band, and also on the
number of band sizes to ensure coverage of the majority of the
patient wrist sizes. If the electrodes are spaced too close
together, the penetrations of the electrical fields are not as deep
into the skin and may not reach the target nerves and/or may cause
discomfort. If the electrodes are spaced too far apart, then a
singular spacing of electrodes may not work for enough wrist sizes
(will not appropriately position the electrodes on wrists of
various sizes), which can yield too many different band sizes and
electrode spacings for the product line. If the electrodes are too
narrow, targeting the nerve will be quite difficult, but if the
electrodes are too wide, then the electrodes cannot be spaced
adequately for enough wrist circumferences, which will yield a lot
of different sized products for the product line. For the wrist,
electrode widths between about 10 mm-30 mm and electrode spacing
between about 5 mm-20 mm can enable encompassing the vast majority
of all individuals using approximately three band sizes, for
example.
[0078] In some embodiments, the stimulation waveform is biphasic
and charge balanced as shown in FIGS. 5A-5G. A biphasic waveform
has a phase of a first polarity (e.g., positive current) and a
phase of the opposite polarity (e.g., negative current). A charged
balanced waveform has a net zero charge when the waveform is
integrated over time (in other words, the cumulative area beneath
the curve is zero). The stimulation waveform can have an excitatory
phase/pulse and a charge balance phase/pulse with the opposite
polarity. The excitatory phase may arise from an electrode serving
as the excitatory electrode and the charge balance phase may arise
from an electrode serving as the charge balance electrode. The
excitatory electrode may be positioned over or proximate to one
nerve (e.g., a first nerve) and the charge balance electrode may be
positioned over or proximate to another nerve (e.g., a second
nerve), as described elsewhere herein. In some embodiments, the
stimulation waveform excitatory phase can excite the nerve located
near the cathode without exciting the nerve under the anode. In
other embodiments, the excitatory phase may be an anodic phase
while the charge balance phase may be the cathodic phase. In some
embodiments, the excitatory and charge balance phases can have the
same amplitude and duration, as shown in FIGS. 5A and 5B, with the
stimulation amplitude as the Y axis and time as the X axis. The
pulse width, pulse spacing, and period variables are also
illustrated. This type of symmetrical stimulation waveform can tend
to stimulate both nerves, such as simultaneously. FIG. 5A
illustrates an embodiment of a biphasic stimulation waveform with a
positive-going leading edge, while FIG. 5B illustrates an
embodiment of a biphasic stimulation waveforms with a
negative-going leading edge. In some embodiments as illustrated in
FIGS. 5A-5B, the waveforms can have square or rectangular shapes
with stimulation at maximum amplitude. Other embodiments can
include curved waveforms where there can be a ramp-up and/or
ramp-down period to or from maximum amplitude. Other embodiments
can include a sinusoidal waveform.
[0079] FIG. 5C illustrates a schematic illustrating a waveform and
a stimulation device 500 positioned on the skin of a subject's limb
502, shown in cross-section. The device 500 can include in some
embodiments 3 electrodes to stimulate 2 nerves (nerves not shown)
with the electrodes grouped as alternating pairs (pair 1 and pair
2). The electrodes serving as activated electrodes 504 and
inactivated electrodes 506 during particular phases of stimulation
are shown. In another embodiment, utilizing exactly two electrodes
to stimulate exactly two nerves such as illustrated schematically
in FIGS. 4A-4D can utilize, for example, symmetrical stimulation
waveforms such as shown, for example, in FIGS. 5A-5B to
simultaneously stimulate exactly two nerves with exactly two
electrodes.
[0080] In other embodiments, the excitatory and charge balance
phases of the stimulation waveform can have different amplitudes
and durations, yet still remain charge balanced or substantially
charge balanced. For example, as shown in FIGS. 5D and 5E, a first
stimulation waveform can have an excitatory phase with a greater
amplitude but a shorter duration than the charge balance phase to
stimulate the nerve close to the electrode serving as the
excitatory electrode such that the excitatory phase and the charge
balance phase are not symmetric (e.g., not mirror inverses of each
other), with the stimulation amplitude as the Y axis and time as
the X axis. The pulse width, pulse spacing, and period variables
are also illustrated. This type of asymmetrical stimulation
waveform can allow for alternating stimulation of nerves (e.g.,
only one nerve at a time in some cases). FIG. 5D illustrates an
embodiment of a biphasic asymmetric stimulation waveform with a
positive-going leading edge, while FIG. 5E illustrates an
embodiment of a biphasic asymmetric stimulation waveforms with a
negative-going leading edge. As shown, the asymmetric waveform can
be configured to be charge balanced such that the area under the
positive-going pulse 552 can be equal to the area under the
negative-going pulse. In some embodiments as illustrated in FIGS.
5D-5E, the waveforms can have square or rectangular shapes with
stimulation at maximum amplitude. Other embodiments can include
curved waveforms where there can be a ramp-up and/or ramp-down
period to or from maximum amplitude. Other embodiments can include
sinusoidal waveforms.
[0081] In FIG. 5F, the charge balance phase may initially have an
amplitude that is equal to or greater than the excitatory phase,
but its duration is relatively brief and the amplitude rapidly
drops such that the waveform is not excitatory (the nerve is not
stimulated), similar to a capacitive discharge. What is important
in some cases is that the charge balance waveform is
non-excitatory. The amplitudes and duration can be configured such
that only one nerve, but not both nerves, is stimulated with the
stimulation waveform, while the other (e.g., second) nerve is not
stimulated by the stimulation waveform. A second stimulation
waveform can also have an excitatory phase with a greater amplitude
but a shorter duration than the charge balance phase, but the
electrodes serving as the excitatory electrode and charge balance
electrode can be switched, by reversing the polarities of the two
electrodes, so that the second nerve is stimulated and the first
nerve is not stimulated.
[0082] In some embodiments, the amplitude (e.g., the mean, median,
or maximum amplitude) of the excitatory phase of the first
stimulation waveform is about or at least about 2, 3, 4, 5, 6, 7,
8, 9, 10, 15, 20, or more times greater than the amplitude (e.g.,
the mean, median or maximum amplitude) of the charge balance phase
of the first stimulation waveform, or within a range incorporating
any two of the aforementioned values. In some embodiments, the
pulse width can be between, for example, about 50 .mu.s to about
1,000 .mu.s. The stimulation amplitude can be, in some cases,
between about 1-15 mA, or between about 1-10 mA, or between about
1-25 mA.
[0083] In some embodiments, the duration of the charge balance
phase (either in total, or the duration of which the charge balance
phase is at maximum amplitude or substantially at maximum
amplitude) of the first stimulation waveform is about or at least
about 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, or more times
greater than the duration of the charge balance phase of the first
stimulation waveform, or within a range incorporating any two of
the aforementioned values.
[0084] In some embodiments, as described above, the same two
electrodes can switch functions as the excitatory electrode and
charge balance electrode between stimulation waveforms/pulses so
that each nerve can be stimulated serially (but not necessarily at
the same time). In some implementations, this may be accomplished
by switching the polarities of the two electrodes and applying the
same or similar stimulation waveform from the second electrode as
the first electrode, as illustrated schematically in FIG. 5G,
showing exactly two electrodes for stimulating exactly two nerves
(N1 and N2) on a patient's limb 502, and the electrodes serving as
the anode 580 and the cathode 582 can change depending on the
desired stimulation pattern. In other implementations, this may be
accomplished by retaining the same polarities but by altering the
amplitudes and durations of the cathodic and anodic phases, such
that a cathodic electrode is used to stimulate the first nerve and
an anodic electrode is used to stimulate the second nerve or
vice-versa. In some embodiments, three, four, or more electrodes as
part of an array, or multiple pairs of electrodes can alternate as
either excitatory electrodes or charge balance electrodes as noted
above.
Stimulation Timing
[0085] Since the nerves can be independently stimulated, it allows
for each nerve to be stimulated, in some embodiments at different
times, as shown schematically in FIG. 5C above. For example, after
the first nerve has been stimulated or has started being
stimulated, the second nerve can begin stimulation after a delay
that can be based on the period of the tremor, T, as shown in FIGS.
6A and 6B. For example, the delay can be the period of the tremor
divided by the number of nerves to be stimulated, which can be
exactly two when just the median and radial nerves are to be
stimulated.
[0086] Some stimulation schemes can be designed to dephase,
override or obscure an abnormal neural network. For example, in
some embodiments for stimulation to reduce hand tremor, as
illustrated in FIG. 6A, a conceptual diagram showing a sample
excitation scheme to dephase brain regions receiving sensory input
from two sites. For example, the two sites could be two locations
on the wrist over the median and radial nerves. The stimulation at
site 2 is delayed after site 1 by time T/2, where T is the period
of the native tremor. For example, if the tremor is at 8 Hz the
period is 125 ms and the stimulation of site 2 would be delayed by
62.5 ms. The stimulation is designed to reset the phase of the
neuron, which may be implemented using high frequency stimulation
(e.g., above 100 Hz) as shown in FIGS. 6A and 6B or a DC pulse.
FIG. 6B is a conceptual diagram showing a sample excitation scheme
to dephase brain regions receiving sensory input from four sites,
with subsequent sites delayed by T/4. In some implementations, the
stimulation scheme is periodic, repeating the stimulation pulses at
regular intervals over a duration of time.
Wearable Band
[0087] In some embodiments as shown in FIGS. 7 and 8, the
electrodes can be disposed on a wearable band that can be worn
around the wrist, arm, ankle, leg, or other limb or body part. The
wearable band may include a removable/detachable controller as
further described in International Application No.
PCT/US2016/37080, titled SYSTEMS AND METHOD FOR PERIPHERAL NERVE
STIMULATION TO TREAT TEREMOR WITH DETACHABLE THERAPY AND MONITORING
UNITS, which is hereby incorporated by reference in its entirety
for all purposes. As shown in FIGS. 7 and 8, the wearable bands
have two electrodes which can be used to stimulate up to two
nerves. However, other embodiments can have N electrodes to
stimulate up to N nerves, wherein N represents a variable integer
number as described elsewhere herein.
[0088] FIG. 7 illustrates a wearable band 800 with disposable
electrodes 802, 804. In some embodiments, the disposable electrodes
802, 804 can be coated or covered with an electrically conductive
material, such as a solid hydrogel or a conductive liquid. The
disposable electrodes 802, 804 may be disposed on a strip 806 that
can be removably attached to the wearable band 800, which may have
a receptacle 808 for receiving the strip 806. Other embodiments may
comprise other means of attaching the strip 806 to the band 800.
The strip 806 and the band 800 can have electrical contacts and a
flexible circuit so that the electrodes are electrically connected
to the controller 810. To accommodate various body part sizes, the
disposable strip 806 can be provided with a variety of electrode
spacings. This allows one band size, which can be adjustable (e.g.,
via an adjustable clasp or hook and loop fastener), to accommodate
users with different body part sizes. In some embodiments, hydrogel
coated electrodes may be more suitable for use with removable
electrodes, as shown in FIG. 7, that can be disposed and replaced
on a regular basis, such as every 1, 2, 3, 4, 5, 6, or 7 days, for
example.
[0089] FIG. 8 shows a wearable band 900 with integrated electrodes
902, 904. In some embodiments, the integrated electrodes 902, 904
can be dry electrodes, described elsewhere herein, in electrical
communication with a controller 910, comprising electronics for
operating the device and a battery, which may be rechargeable. In
some embodiments, the controller 910 may be detachable from the
band 900. The electrodes 902, 904 may be in electrical
communication with the controller 910 through a flexible circuit
embedded in the band 900. Dry electrodes may be more suitable for
longer term use electrodes that can be used for months, such as at
least 3 months, before the band needs to be replaced. In some
embodiments, the band may be a single use band that can be used for
a relatively long period of time before replacement.
Dry Electrodes
[0090] A dry electrode for transcutaneous electrical stimulation
and/or for electrical sensing can be used for many applications,
including but not limited to peripheral nerve stimulation for
treating tremor, osteoarthritis, overactive bladder, high blood
pressure, dysrhythmias, pain, diabetes, and inflammatory diseases.
Dry electrodes advantageously do not require any adhesive or layer
of conductive moisture (such as a gel or spray) to achieve the skin
contact sufficient for comfortable delivery of electrical
stimulation. In contrast, wet electrodes utilize either integrated
adhesives or conductive gels and moisture to achieve that contact
and electrical connection. Some such examples are hydrogels, which
can be adhesive or non-adhesive. The gels and moisture tend to dry
out over time and the adhesives tend to only be effective for one
use due to contamination from adhesion of dead skin cells, dirt,
etc. As such, wet electrodes tend to be not reusable or only
reusable for a short period of time, for example less than one day,
even when stored optimally. Dry electrodes allow the electrode to
be effectively used for relatively long periods of times, such as
for about or at least about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or
12 months, 1, 2, 3, 4, 5 years, or more before the electrode needs
to be replaced.
[0091] There are several challenges in developing a dry electrode
in a body-worn device that provides comfortable transcutaneous
stimulation. First, the electrode can in some cases have a bulk
resistivity (e.g., the inverse of conductance) that is near the
resistivity of skin, or resistivity high enough to allow for a
uniform distribution of current through the electrode, as
concentration of current, especially around electrode edges or
imperfections in the electrode surface, can cause uncomfortable
stimulation. Most dry electrode materials utilize a polymeric base
material, such as silicone, loaded with a conductive filler
material, such as carbon. Bulk resistivity depends on the amount of
filler material loaded into the base polymer, and also the
resistivity of the base polymer. In some implementations, optimal
bulk resistivity for providing good conduction in a body-worn
device may be between about 25 and about 2000 ohm-cm, between about
50 and about 1000 ohm-cm, or between about 100 and about 500
ohm-cm.
[0092] Second, the electrode can be configured to be compliant
enough to provide conformance to the skin, especially around bony
structures such as the radius and ulnar bones in the wrist. If the
material is too stiff and cannot conform to the skin, areas of the
electrode surface can lift from the skin, causing concentrations in
current and uncomfortable stimulation. Compliance of the electrode
depends on the base polymer material properties, the amount of
conductive filler material loaded into the base polymer, and the
thickness of the electrode. For example, more filler material tends
to lead to a less compliant (or stiffer) electrode. Additionally, a
thicker electrode will tend to be stiffer than a thinner electrode.
In some implementations, a preferred durometer for providing good
conformance to a dry electrode may have a Shore hardness between
about 25 A and about 55 A, between about 30 A and about 50 A, or
between about 35 A and about 45 A.
[0093] Third, the electrode can in some cases have uniform material
properties across the surface of the electrode, which must be
controlled during manufacturing. Drastic inhomogeneities in
properties of the electrode surface, such as resistivity or surface
finish, can also cause concentrations in current and lead to
uncomfortable stimulation. In some implementations, an optimal
measure of homogeneity for providing uniform current distribution
may be less than about 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or less
difference in resistivity across the electrode surface. Uniform
material properties of a dry electrode depend upon a uniform
distribution of the conductive filler material in the base polymer
and a uniform surface finish across the electrode, the latter of
which is typically controlled by the surface finish of a mold.
These three properties of the electrode affect each other, so
designing a cost-efficient, manufacturable, and durable dry
electrode material that provides comfortable transcutaneous
stimulation requires optimizing these multiple parameters.
[0094] In some embodiments, as shown in FIGS. 9A-9D, the dry
electrode 100 includes a conductive base layer 102 and a conductive
skin contact layer 104 made of a conductive plastic, rubber,
silicone material, or other suitable dry material. In some
embodiments, the base layer 102 can include a thin layer of
conductive material (e.g., copper, gold, silver-coated copper,
stainless steel, silver, silver chloride, titanium, other metals or
metal alloys, combinations thereof, polydimethylsiloxane, etc). In
some embodiments, the base layer 102 can include metal coated
polymer or plastic. In another configuration, the base layer 102
can include conductive polymer or plastic. In some embodiments, any
two, three, or more materials such as those disclosed herein can be
combined to make a base layer 102. The base layer 102 may be, for
example, a continuous metal or a patterned metal. The size of metal
patterns can be relatively large, such as, for example, between
about 50% and about 70% of the surface area of the base layer 102,
or about or at least about 50%, 55%, 60%, 65%, 70%, 75%, or 80% (or
ranges incorporating any two of the aforementioned values) of the
surface area of the base layer 102 and still maintain a uniformity
of current density of the electrode depending on the conductivity
of the dry electrode 100 as well as the frequency of the waveform
being delivered. Keeping the base layer 102 thin may allow
increased flexibility, desirable for body-worn applications,
especially where a stiff material is used. Using a patterned metal
may also enhance the flexibility of the base layer 102.
[0095] In some embodiments, the dry electrodes 100 need to maintain
good skin contact across the surface of the skin contact layer 104
in order to deliver comfortable transcutaneous electrical
stimulation at the appropriate current. As such, the materials that
make up the dry electrodes 100 typically are more conformal
materials that are loaded with conductive materials. Challenges
also lie in the ability for the base layer 102 to maintain
flexibility without deforming or fracturing. The strong, secure
electrical connection between the base layer 102 and the conductive
layer 104, which in some embodiments are two or more different
materials, can also be important in some cases to prevent
delamination, which can cause the conductance to greatly
decrease.
[0096] In some embodiments, the skin contact layer 104 is disposed,
layered or coated over the base layer 102 and may include any
moldable polymer, rubber, or plastic, including but not limited to
silicone, rubber, or thermoplastic urethane. The material could be
loaded with one or more conductive fillers, including but not
limited to metal, carbon (e.g., carbon nanotubes or carbon black),
graphite, and metal coated particles (e.g., metal-coated, such as
silver-coated glass microspheres or bubbles). In some embodiments,
the conductive filler material may be a mixture of different filler
materials with different conductivities. For example, in some
embodiments, a first highly conductive material (e.g., a metallic
material) may be mixed with a second material with lower
conductivity with respect to the first conductive material, such as
carbon black, in order to increase the conductivity of the second
filler material. The second material may have better physical
properties (e.g., reduced stiffness) than the first material.
Mixing filler material may allow less filler material to be used,
resulting in a more flexible skin contact layer 104.
[0097] In some embodiments, as shown in FIG. 9B, the conductive
filler material can be in a fiber form. In some embodiments as
shown in FIG. 9C, the conductive filler material can be in a
powdered or particulate form when added to the silicone, rubber, or
plastic material. In some embodiments, a powdered form may be
preferable over a fiber form in order to create a more uniform
conductance across the surface of the loaded material. Long fiber
length materials may extend through the entire thickness of the
skin contact layer 104 and/or may be more difficult to evenly
disperse, thereby creating areas of high conductance in some
locations and areas of low conductance where the fibers are absent.
The areas of high conductance may transmit too much current to the
skin and cause pain or discomfort. In contrast, powder materials
may be more easily and more uniformly dispersed throughout the skin
contact layer to yield a material with uniform conductance across
its surface. However, in some embodiments, materials that include
fibers can be utilized.
[0098] In some embodiments as shown in FIG. 9D, the skin contact
layer 104 can include open cell foam treated with a conductive
surface coating that causes the foam to be conductive. The open
cell foam can provide a high surface area-to-volume ratio which
allows increased incorporation of the conductive coating. In some
embodiments, the foam pattern is random and in some embodiments, it
is not random. In some embodiments, the skin contact layer 104 can
include a non-conductive substrate made from a porous material,
including but not limited to foam, neoprene, sponge, etc. filled
with a conformal conductive coating that allows current to pass
from the base layer backing 102 to the skin contact layer 104.
[0099] In some embodiments, a fibrous filler material may tend to
increase the stiffness or durometer of the loaded material more
than a powdered filler material. Also, more generally, as more
filler is added and the concentration of filler increases, the
loaded material tends to increase in stiffness. However, a low
durometer, flexible material can be desirable in some embodiments
to result in good conformance to the skin, which improves the
physical comfortability of wearing the electrode 100. In addition,
poor conformance to the skin can lead in some cases to the
concentration of current through the electrode 100 to a smaller
area still in contact with the skin, leading to the perception of
pain if the resulting current density is too high. Therefore, in
some embodiments where increased flexibility is desirable, a
powdered filler material may be preferred and the amount of filler
material can be limited or reduced in order to keep the durometer
of the material within a desired limit. In some embodiments, the
powder or particulate filler material can possess a diameter,
length, width, and/or thickness that is less than about 1/3, 1/4,
1/5, 1/10, 1/100, or less than the thickness of the skin contact
layer 104. The amount or loading of filler material can affect both
conduction and stiffness. The optimal loading amount will generally
depend on the materials used for both the skin contact layer 104
and the conductive filler. In embodiments having a skin contact
layer 104 comprising a silicone base polymer material,
silver-coated glass bubbles having diameters of, for example,
between about 10 .mu.m and about 100 .mu.m, between about 18 .mu.m
and about 50 .mu.m, or approximately 18 .mu.m, 25 .mu.m, 35 .mu.m,
or 50 .mu.m. can have a loading for example, of between about 1%
and about 40%, between about 3% and about 25%, between about 5% and
about 20%, or about 5%, about 10%, or about 20% (measured by weight
or volume). In embodiments having a skin contact layer 104
comprising a silicone base polymer material, a preferred loading of
conductive single walled carbon nanotubes (SWCNT) may be, in some
embodiments, about or less than about 10%, 9%, 8%, 7%, 6%, 5%, 4%,
3%, 2%, 1%, or less, or between about 1% and about 5% (measured by
weight or volume). In some embodiments, incorporation of such
materials can be unexpectedly advantageous when used as dry
electrode materials. For example, glass bubbles can reduce weight
of material, as the density is lower than most polymers (because
bubbles are filled with air). Conductivity of the filler material
can be controlled with the type of silver or silver alloy applied
to the glass bubble. The spherical shape of the bubbles can
advantageously allow for uniform or substantially uniform
dispersion the in base polymer. SWCNTs have high conductivity
(e.g., 10.sup.6 to 107 S/m) and robust mechanical properties
(combination of stiffness, strength, and tenacity) as a filler
material within a polymer. Loading of SWCNTs can be more efficient
(by weight or volume) than carbon black or carbon fibers as the
structure of SWCNTs allow better transfer of their mechanical load
to the polymer matrix. Conductivity of SWCNTs can be controlled
during manufacturing by the chiral vector, C=(n, m), the parameter
that indicates how the graphene sheet is rolled to form a carbon
nanotube. Both materials can advantageously require less loading by
volume to achieve required conductivity and changes in conductivity
are less sensitive to deformation of the electrode material, for
example due to applied pressure or forces during wear.
[0100] In some embodiments, any number of the following materials
could be incorporated into a dry electrode: metals and metal alloys
(e.g., stainless steel, titanium (e.g., 6AI-4V (Ti64) or cobalt
chrome); graphite coated with pyrolytic carbon (e.g., pyrolytic
carbon AXF-5Q POCO); a conductive ink/coating (e.g., silver or
silver chloride printed ink); a self-wound transfer adhesive that
can include an electrically conductive pressure-sensitive adhesive,
e.g., ARcare 90366 from Adhesives Research, Glen Rock, Pa.); a
double-sided, isotropically conductive pressure sensitive tape
which conducts electricity through the thickness (the Z-axis) and
the plane of the adhesive (X, Y planes) e.g., XYZ-Axis Electrically
Conductive Adhesive Transfer Tape 9719 from 3M, Maplewood, Minn.);
a conductive fabric having multiple layers (e.g., screen printed
breathable fabric electrode arrays); a textile electrode that
includes silver-coated nylon (e.g., a conductive fabric that
includes silvered polyamide and/or Spandex); silver-plated,
aluminum-filled fluorosilicone; a thermoplastic elastomer with
conductive particle filler (e.g., X TP-1494502 Natural from
STAT-TECH, PolyOne Corp., Avon Lake, Ohio); silicone filled with
nanoparticles (e.g., silver nanoparticles, such as LTE-75 from
Leader Tech (Tampa, Fla.); thermoplastic polyolefin elastomer
(TEO), and/or thermoplastic vulcanizate (TPV) styrene ethylene
butylene styrene (SEBS) alloy with carbon black (e.g., ESD C2800
B-45A Black from RTP Co., Winona, Minn.); electrically conductive
silicone (e.g., silver plated aluminum such as SSP-2368 from
Specialty Silicone Products, Inc., Ballston Spa, N.Y.); silicone
elastomers with silver fillers; conductive elastomers such as
silicone with carbon black (e.g., NuSil EPM-2461P from NuSil
Technology, Carpinteria, Calif.); and/or a hydrogel (e.g.,
Axelgaard AG735 from Axelgaard Manufacturing Co. Ltd., Fallbrook,
Calif.).
[0101] The resistance of the skin contact layer 904 can increase
proportionally with thickness; therefore minimizing thickness of
the skin contact layer 904 can improve conductivity of the
electrode 900. Higher resistance in the electrode 900 due to a
thicker skin contact layer 904 could increase power required in the
system to maintain the desired current. However, if the skin
contact layer 904 is too thin, variations in the processing could
cause significant inhomogeneity in the material properties and/or
conductance at the skin contact layer 904. The skin contact layer
904 thickness can be, in some embodiments, between about 0.25 mm
and about 5 mm, between about 0.5 mm and about 2 mm, between about
0.5 mm and about 1 mm, between about 1 mm and about 2 mm, between
about 0.15 mm and about 10 mm, or ranges including any two of the
aforementioned values or ranges there between.
[0102] Overall, the thickness of the electrode 900 can affect its
flexibility and stiffness, with the stiffness increasing with
increasing thickness. In some embodiments, the thickness of the
skin contact layer 904 depends of the material properties (e.g.,
natural durometer) of the selected material, such as silicone, the
choice of filler (e.g., for providing conductivity), and the
desired durometer and desired resistivity or conductance of the
conductive filler loaded skin contact layer 904. In some
embodiments, the skin contact layer 904 of the electrode 900 can
have a durometer between a shore hardness of about 10 A to 50 A,
between about 10 A and about 30 A, between about 50 OO and about 50
A, between about 40 OO and about 70 A, or ranges including any two
of the aforementioned values or ranges there between. In some
implementations, these durometers can provide good conformance to
the skin. As discussed above, the durometer can be controlled by
various factors, including material selection, thickness of the
layers, and the type and/or amount of the conductive filler added
to the skin contact layer 904. Additionally, the surface tackiness
of the electrode 900 could be modified to enhance or decrease
gripping against the skin (i.e., friction or resistance to shear
force). Enhanced gripping (as in the case of a fully smooth
electrode) could aid in skin conformance and reduction of sliding,
which would reduce the unpleasant changes in stimulation intensity
experienced by a wearer. In some embodiments, the skin-contacting
surface 904 of the dry electrode 900 is smooth and flat, and lacks
any spikes, projections, bumps, microneedles, or similar features.
However, other embodiments could have a curved, domed, or tapered
shaped electrode surface that could help improve contact with the
skin at the center of the electrode, where current is delivered, by
applying more contact force and reducing likelihood of sliding. In
some embodiments, the curved or domed electrode 1900 can have a
backing material 1902 that is as or more compliant as the electrode
material 1900, as illustrated in FIG. 9E, to apply appropriate
pressure for good skin conformance. Also illustrated is a band 1901
which can be circumferential in some embodiments and configured to
attach to a plurality of spaced apart electrodes as disclosed
elsewhere herein. In some embodiments, the curved dry electrode
1900 does not require a separate backing material, as illustrated
in FIG. 9F. In some embodiments, as illustrated in FIG. 9G the
backing material 1902 is also curved or domed to match the shape of
the dry electrode 1900, which could provide beneficial adhesion of
the two layers during manufacturing or control stiffness of the dry
electrode assembly. FIG. 9H schematically shows a side view of a
tapered electrode 1000 to improve the conformability and control of
delivery of current at the edges of the electrode. As shown, the
electrode 1000 can be thicker in the center of the electrode than
at the peripheral edges of the electrode. In some embodiments, the
thickness at the center of the electrode 1000 can be about or at
least about 1.5.times., 2.times., 2.5.times., 3.times., 4.times.,
5.times., 6.times., 7.times., 8.times., 9.times., 10.times., or
more times the thickness at the peripheral edges of the
electrode.
[0103] Additionally, concentrated delivery of current to the skin
due to edges of the electrode can in some cases cause pain or
discomfort; a curved shape would also increase the radius of edges
to reduce likelihood of current concentrations. However, other
embodiments can include one or more of the aforementioned features.
However, if too tacky, this could make the band of a wearable
device difficult to slide over the appendage. In this case, more
subtly texturing the surface and/or treating the skin contact layer
904 with a coating could provide a more moderate level of
tackiness.
[0104] The thickness and patterning of the base layer 902 can also
in some cases affect the ability of the electrode to mechanically
bend and conform to different body parts, like the arm, wrist,
hand, knee, ankle, or leg, for example. Continuous metal foils or
films on thin polyimide substrates can be good candidates for
producing flexible bands. Continuous metals can, in some
embodiments, preferably be ductile enough to produce the bends
needed for the particular appendage--for instance in a typical gold
coated flex application, copper is coated with nickel and then
passivated with gold. In some embodiments, because nickel tends to
be brittle and crack, only a thin layer of nickel is desired. This
flexibility could also be increased by patterning the backing
material in a serpentine fashion along the direction of the
bending. Additionally, other more ductile metals such as silver
could be used for the conductive base layer backing 902.
[0105] The adhesion of the skin contact layer to the base layer can
be important as delamination can cause the electrical current to be
unable to pass to the wearer. Adhesion can be improved using
mechanical elements, as shown in FIGS. 10A-10C. FIG. 10A
illustrates a base layer 1002 with no mechanical attachment or
adhesion means for adhering to the skin contact layer. FIG. 10B
illustrates a base layer 1002 with a plurality of holes 1003
positioned uniformly around the perimeter of the base layer 1002.
FIG. 10C illustrates a base layer 1002 with a plurality of holes
1003 positioned uniformly around the perimeter and a larger hole
1003' positioned approximately in the center of the base layer
1002. These holes 1003, 1003' allow the skin contact layer material
(e.g., silicone) to surround (e.g., penetrate) the base layer 1002
upon application (e.g., overmolding) and maintain good contact. Any
combination of these holes 1003, 1003' may be used across the base
layer 1002. In addition, surface treatments such as primers, corona
or plasma treatments can be used to prep the surface of the base
layer 1002 material for promoting adhesion of the skin contact
layer.
[0106] In some embodiments, instead of overmolding directly onto
the base layer, the skin contact layer can be adhered to the base
layer using loaded glues (e.g., silver epoxies) or other conductive
adhesives such as Z-axis tapes that allow conduction only in the
z-direction across the thickness of the tape and not along the
length or width of the tape (i.e., the direction perpendicular to
the surface of adhesion). Provided the interface is thin enough,
nonconductive adhesives can also be utilized in some
embodiments.
[0107] To provide stimulation that is comfortable to the wearer,
several features of the electrode can be desirable in some
embodiments as discussed elsewhere herein. One electrode feature in
some embodiments is to provide the electrode surface with a
substantially uniform homogeneity of conductance, meaning that the
current is transmitted evenly across the skin contact surface of
the electrode. To validate whether the electrode surface has a
substantial uniform homogeneity of conductance, the end-to-end
resistance or conductance of the skin contact layer, or the entire
electrode with the base layer added to the skin contact layer, can
be measured at a plurality of points across the entire skin contact
surface of the electrode. In some embodiments, the standard
deviation of the measured resistivity or conductance at the
plurality of points is less than about 10, 15, 20, 25, 30, 35, 40,
45, or 50 (on an absolute, like ohm-cm, or percentage basis) more
or less than the average value or mean value of the measured
resistivity or conductance. In some embodiments, verifying whether
the current passing through the skin contact surface is uniform can
be measured at a plurality of points across the entire skin contact
surface of the electrode. In some embodiments, the standard
deviation of the measured current at the plurality of points is
less than about 10, 15, 20, 25, 30, 35, 40, 45, or 50 (on an
absolute, like milliamps, or percentage basis) more or less than
the average value or mean value of the measured current.
[0108] In some embodiments, the dry electrodes can be disposed in a
band that applies pressure, such as radially inward pressure in
some cases, in order to maintain good contact and a good electrical
connection with the skin. Various embodiments of the band, such as
a D-ring, or inflatable cuff, are all bands that when combined with
thin dry electrodes can provide the skin conformance needed to
provide good electrical contact. In some cases, the pressure
required to provide effective electrical contact is around 10-40
mmHg, around 5-50 mmHg, around 15-300 mmHg, or ranges including any
two of the aforementioned values or ranges there between.
[0109] In some embodiments, the conductive material forming the
skin contact layer has a high volume resistivity that can be
between about 1 ohm cm and about 2000 ohm cm, between about 20 ohm
cm and about 200 ohm-cm, between about 100 ohm-cm and about 1000
ohm cm, between about 5 ohm-cm and about 100 ohm cm, between about
1 ohm cm and about 10,000 ohm-cm, or ranges including any two of
the aforementioned values or ranges there between. These
resistivity ranges can be comparable with current hydrogel
electrodes. A lower volume resistivity can result in discomfort
during stimulation, while a higher volume resistivity can result in
power loss. Therefore, in some embodiments, a moderate volume
resistivity may be optimal.
[0110] In some embodiments, the electrode can have a lower
resistivity towards the center of the electrode and a higher
resistivity toward the edges of the electrode to reduce the
likelihood of concentration of current being delivered through the
edges of the electrode (i.e., spreading the current across the
surface of the electrode). Concentrated delivery of current to the
skin due to edges of the electrode can cause pain or discomfort.
Resistivity of the electrode can be controlled by varying the
concentration of conductive filler material throughout the
electrode 1200, as illustrated in FIG. 10E, schematically
illustrating a cross-section of a dry electrode that can include a
first outer zone 1202 with less filler material at the edge of the
electrode with relatively low conductivity, a second middle zone
1204 with more filler material than the outer zone 1202 with
relatively intermediate conductivity, and a third inner zone 1206
with more filler material than the first outer zone 1202 and the
second middle zone 1204 and relatively high conductivity. Some
embodiments could have a different number of zones, such as two,
four, five, or more zones, or a gradual conductivity gradient
within each zone. In some embodiments, the resistivity of the
electrode can be controlled by varying the profile shape of the
electrode, such as a star pattern 1100 as illustrated in FIG. 10D,
or by varying the thickness of the electrode, such as having an
electrode that is thicker toward the center and thinner toward the
edges, as illustrated in FIG. 9E, which illustrated the side view
of an electrode with a tapered profile. FIG. 9E schematically shows
a side view of a tapered electrode 1000 to improve the
conformability and control of delivery of current at the edges of
the electrode. As shown, the electrode 1000 can be thicker in the
center of the electrode than at the peripheral edges of the
electrode. In some embodiments, the thickness at the center of the
electrode 1000 can be about or at least about 1.5.times., 2.times.,
2.5.times., 3.times., 4.times., 5.times., 6.times., 7.times.,
8.times., 9.times., 10.times., or more times the thickness at the
peripheral edges of the electrode. As illustrated in FIG. 10D, the
top view of the star pattern electrode 1100 can include a central
hub 1102 with a plurality, such as about or at least about 3, 4, 5,
6, 7, 8, 9, 10, or more radially outwardly extending projections
1104. The electrode can be integrally formed in some embodiments.
In some embodiments, the patterned electrode can include a
non-conductive material, such as silicone, wherein the star or
other pattern is conductive and the outer, surrounding material is
non-conductive, such as via a two-part molding process. In some
embodiments, controlling the spatial resistivity of the electrode,
for example by the amount of filler material, can also control the
location of current delivery to stimulate skin and nerves in one or
more preferred locations.
[0111] The shape of the electrode can also contribute to the
ability to conform to the skin. If an electrode has edges and/or
corners, such as in a square or rectangle shape, for instance, the
edges and corners can deform and bend downward into the wearer's
skin. This deformation can lead to uneven pressure at the skin
contact layer, which can lead to localized concentration of current
flow and discomfort. FIGS. 11A and 11B illustrate electrode shapes
that may optimize conformity with the skin and homogenous current
distribution. FIG. 11A illustrates a side cross sectional view of
an electrode 1100. FIG. 11B illustrates a top view of an electrode
1100', which may be the same or a different electrode as electrode
1100 shown in FIG. 11A. Shapes, such as the pillowed-shape profile
electrodes with tapered (e.g., rounded, non-sharp) edges as
illustrated in FIG. 1A and/or electrodes with rounded corners as
illustrated in FIG. 11B, prevent discomfort by reducing deformation
of the electrode around the corners and edges when coming into
contact with a person's skin. In some embodiments, the electrodes
can have a generally square or rectangular geometry. In some
embodiments, the electrodes can have an arcuate, e.g., circular or
oval geometry (e.g., from a top view). Additionally, electrodes can
in some cases protrude beyond the band surface to ensure that the
electrode is the primary material touching the person's skin.
Additionally, the shape of the electrode can also help with
conformance--for instance, squares with rounded corners can reduce
the chances of a single point contacting the skin.
Testing Apparatus
[0112] FIGS. 12A and 12B illustrate example of testing apparatuses
for testing conductance of dry electrodes. FIG. 12A illustrates an
embodiment of a pinpoint tester 1200 that can be used to assess the
dry electrode consistency and uniformity of the resistance or
conductance across the surface of the dry electrode. The pinpoint
tester 1200 can have a first plate with a first array of electrodes
1202 that spans the entire area of the dry electrode to be tested,
and a second plate (not visible) with a second array of electrodes
that corresponds with the first array. For testing, the dry
electrode or just the skin contact layer can be inserted between
the two plates and compressed to a typical wearing pressure to
ensure contact between the electrode arrays and the dry electrode.
The pinpoint tester 1200 can then simultaneously measure the
resistance or conductance of the dry electrode at a plurality of
discrete points across the entire surface of the dry electrode. The
resistance or conductance of the individual points can be
statistically compared to determine the consistency or uniformity
of material properties across the electrode surface. FIG. 12B shows
an embodiment of a cylindrical tester 1204 used to measure the
impedance of a configuration of electrodes affixed to a band
attached around the cylindrical tester 1204 under a certain
pressure/band pull force. The cylindrical tester 1204 can be used
to approximate a relationship between the amount of pressure/force
applied to the band and the conductance of the electrodes.
Increased pressure/force should promote better contact/conformity
between the dry electrodes and the cylindrical tester 1204,
allowing better conduction between the electrodes and cylindrical
tester 1204.
Wearable Band Configured for Dry Electrodes
[0113] FIG. 13A illustrates examples of an electrode 500 that is
attached to the band through a snap fitting. The electrode 500 may
comprise a number of apertures, such as around the perimeter of the
electrode 500 that allows mechanical snaps to secure the electrode
500 to a band. FIG. 13B illustrates examples of an electrode 500'
that is attached to the band through a welded wire 502 or
electrical trace. The wire 502 may be welded to the electrode 500'
and threaded into or otherwise secured to a band. The snap fitting
requires more structural support than a direct wire connection, and
therefore, the snap fitting tends to increase the rigidity of the
electrodes on the band. By using a direct wire 502 or electrical
trace connection, the flexibility of the electrodes 500' on the
band can be improved, which improves skin conformance.
[0114] FIGS. 14A-14F illustrate an embodiment of a band 600
comprising 3 dry electrodes 602. FIG. 14A illustrates an underside
or skin-facing side of the band 600. FIG. 14B illustrates an outer
side or non-skin-facing side of the band 600, configured for
attaching to a nerve stimulation device. FIG. 14C illustrates a top
perspective view of the band 600 including a nerve stimulation
device 600. FIG. 14D illustrates a bottom view of the skin-facing
side of the band 600 including the nerve stimulation device 604.
FIG. 14E illustrates a side view of the band 600 in a strapped
configuration as if worn around a limb. FIG. 14F illustrates a top
view of the band 600 including the nerve stimulation device 604. In
some embodiments, the dry electrodes 602 may be aligned along the
longitudinal axis of the band 600. The dry electrodes 602 can be
spaced apart as illustrated in FIGS. 14A-14F. The dry electrodes
602 may be electrically attached to an electrical device, such as
an electrical nerve stimulation device 604. The band 600 can have
an elastic strap 606 (FIG. 14A) that allows the band 600 to be
tensioned around the body part, such as the wrist, arm, ankle, or
leg, for example. The band 600 can also use a hook and loop
fastener 608 (FIG. 14B) to provide continuous adjustment
capabilities which allows an adjustable amount of tension and
pressure to be applied by the electrodes 602 to the wearer's skin.
Flexible circuits can be incorporated into one or more layers in
the band 600, as further described elsewhere herein, which
electrically connect the electrodes 602 to at least one electrical
connection tab 610 (FIG. 14B) on the side of the side of the band
600 which attaches to the electrical nerve stimulation device 604.
The electrical connection tab 610 can be electrically coupled and
physically secured to the electrical nerve stimulation device 604.
In some embodiments, there may be two tabs on the band 600, both of
which can be used to physically secure the electrical nerve
stimulation device to the band 600, but only one tab may provide
the electrical connection. In some embodiments, both tabs provide
an electrical connection. In some embodiments, the electrical
connection tabs 610 are separate from attachment tabs or features
that are used to physically secure the electrical nerve stimulation
604 device to the band 600.
[0115] FIGS. 15A-15D illustrate examples of the various layers and
components that can comprise an embodiment of the band 700 with dry
electrodes 702. As shown in FIG. 15A, the top layer 704 of the band
700 can have an elastic portion 706, a D-ring 708 attached to one
of the band 700 for receiving the other end of the band 700 and
allowing it to loop back on itself, and a hook and loop fastener
710 (e.g., Velcro) on the non-skin facing side of the band 700 for
securing the band 700 around a body part. FIG. 15B illustrates the
flex circuit 712 layer with overmolded conductive silicone
electrodes 702 and an electrical connection tab 714. The base layer
of the dry electrodes 702 may be directly integrated into the flex
circuit 712. The electrical connection tab 714 can be an extension
of the flex circuit that can be connected to an electrical nerve
stimulation device. FIG. 15C illustrates an adhesive layer 716 with
backing (e.g., 3M.TM. adhesive) that is used to attach the flex
circuit 712 layer to the bottom layer 718 shown in FIG. 15D. The
adhesive layer 716 may accordingly be adhesive on both sides. The
adhesive layer 716 can have cutouts for receiving the electrodes
702. The bottom layer 718 has cutouts for receiving the electrodes
702 and an adhesive (e.g., a heat activated adhesive) disposed
around the outer areas of the bottom layer 718 for attaching the
bottom layer 718 to the top layer 704. As shown in FIG. 15D, a
first area 719 (the darker/black area) of the bottom layer 718
corresponds and is attached to the adhesive layer 716. The first
area 719 may be polycarbonate or another material specifically
configured to adhere to the adhesive layer 716. A second area 720
(the lighter color area) may comprise the adhesive used to attach
the top layer 704 and bottom layer 718 together. The skin-facing
side of the bottom layer 718 can be a fabric or other comfortable
material.
[0116] FIGS. 16A-16F illustrate the assembly (in numbered steps
1-7) of the band 700 and electrodes 702 shown in FIGS. 15A-15D.
FIG. 16A illustrates the attachment of one side of the adhesive
layer 716 to the flex circuit 712 layer. Then, as shown in FIG.
16B, the bottom layer 718 can be attached to the other side of the
adhesive layer 716, thereby securing the flex circuit 712 layer to
the bottom layer 718. Next, as shown in FIG. 16C, the adhesive used
to attach the top and bottom layers 704, 718 can be activated
(e.g., heat activated or UV activated). In other embodiments, a
non-activated adhesive may be applied prior to this step. In some
embodiments, the adhesive can change color when activated, which
lets the person assembling the band know when the bottom layer 718
is ready to be attached to the top layer 704. Then, as shown in
FIG. 16D, the top layer 704 can be attached to the bottom layer
718, thereby sandwiching the flex circuit layer 712 between the top
layer 704 and bottom layer 718. The electrical connection tab 714
can be inserted through a slit or opening in the top layer 704.
FIG. 16E illustrates the electrical connection tab 714 and separate
physical securement tabs 720 that can be used to fasten a device to
the band 700. FIG. 16F illustrates both sides of a fully assembled
band 700, with step 6 showing the fully assembled skin-facing side
of the band 700 and step 7 showing the fully assembled
non-skin-facing side of the band 700. An electric nerve stimulator
device, as described elsewhere herein, may subsequently be secured
to the non-skin-facing side of the band 700.
[0117] In some embodiments, the band may have two or more tension
settings that are adjustable by interacting with the band, such as
through a control, e.g., a button or dial that adjusts band length
to pre-selected settings or through a working range. The first
tension setting could be at tension that applied enough pressure
between the electrode and the wearer's skin for good conformance
and comfortable stimulation during a specified stimulation session
period. The second tension setting could be at a tension less than
the first setting that secures the device to the wearer's limb, but
not with enough pressure for good skin conformance, to allow for
comfortable all day wear. The device could prevent stimulation at
the second lower tension setting. Tension and pressure could be
adjusted, for example, by changing the length of the band attached
to the wearer's wrist or by inflating the band.
EXAMPLES
Example 1
[0118] FIGS. 17A and 17B demonstrate dramatic tremor reduction
after providing electrical stimulation to nerves in the patient's
wrist in accordance with the embodiments described herein. FIG. 17A
is an example of the tremor reduction detected using a gyroscope to
measure the tremor energy during a postural hold. The severity of
the tremor is measured by the energy output according to the hand
gyroscope. Two baseline measurements were recorded with no
stimulation. The energy was measured for different durations of the
postural hold (0, 10, 20, or 30 min) either before, during, or
after application of a therapeutic stimulation protocol by a nerve
stimulation device as described according to the embodiments
herein. The results demonstrate discernable reduction in hand
tremor both during and after the stimulation. FIG. 17B is an
example of the tremor reduction as detected by having the patient
draw a spiral before nerve stimulation (left) and after nerve
stimulation (right). The spiral pattern is noticeably less
distorted after nerve stimulation treatment. Stimulation was
delivered for about 40 minutes. In some embodiments, stimulation
can be delivered from between about 40 minutes to about 120
minutes, or up to about 8 hours in some cases.
Example 2
[0119] FIG. 18A illustrates examples of an embodiment of a wearable
band 1800 comprising two dry electrodes 1802 that was tested on 15
subjects in order to determine if the electrodes were comfortable
for all day use. Subjects were stimulated for 120 minutes, which
was equivalent to about 3 typical stimulation sessions for treating
hand tremors due to essential tremor. In addition, subjects wore
the band 1800 for an additional 8 hours without stimulation, for a
total wear time of 10 hours per day. The target acceptance criteria
was that at least 80% of the subjects would find the device
comfortable for all day use.
[0120] FIGS. 18B-18F illustrates preliminary data from the study
that show that the vast majority of subjects felt that wearing and
using the dry electrodes was comfortable. FIG. 18B shows the
distribution of wrist size (small, medium, or large) for 14 of the
subjects. Small wrists sized at or under 13.5-15.5 cm, medium
wrists sized between 15.5-17.5 cm, and large wrists sized at or
above 17.5-19.5 cm. As shown in FIG. 18C, 79% of the subjects did
not experience pain from a 2 hour stimulation using the dry
electrode, 14% of the subjects experienced only transient pain, and
only 7% of the subjects experienced persistent pain. As shown in
FIG. 18D, at least 86% of the subjects felt that wearing the
electrodes throughout the day was comfortable (experienced no
discomfort). As shown in FIG. 18E, at least 79% of the subjects
felt no itchiness from the 2 hour stimulation, and only 14% of the
subjects felt transient itchiness, while no subjects had yet
reported persistent itchiness. FIG. 18F shows preliminary
distributions of the number of subjects experiencing relative
pain/comfort levels (comfortable, transient itch, transient pain,
persistent pain) at various levels (currents) of nerve
stimulation.
[0121] When a feature or element is herein referred to as being
"on" another feature or element, it can be directly on the other
feature or element or intervening features and/or elements may also
be present. In contrast, when a feature or element is referred to
as being "directly on" another feature or element, there are no
intervening features or elements present. It will also be
understood that, when a feature or element is referred to as being
"connected", "attached" or "coupled" to another feature or element,
it can be directly connected, attached or coupled to the other
feature or element or intervening features or elements may be
present. In contrast, when a feature or element is referred to as
being "directly connected", "directly attached" or "directly
coupled" to another feature or element, there are no intervening
features or elements present.
[0122] Although described or shown with respect to one embodiment,
the features and elements so described or shown can apply to other
embodiments. It will also be appreciated by those of skill in the
art that references to a structure or feature that is disposed
"adjacent" another feature may have portions that overlap or
underlie the adjacent feature.
[0123] Terminology used herein is for the purpose of describing
particular embodiments only and is not intended to be limiting of
the invention. For example, as used herein, the singular forms "a",
"an" and "the" are intended to include the plural forms as well,
unless the context clearly indicates otherwise. It will be further
understood that the terms "comprises" and/or "comprising," when
used in this specification, specify the presence of stated
features, steps, operations, elements, and/or components, but do
not preclude the presence or addition of one or more other
features, steps, operations, elements, components, and/or groups
thereof. As used herein, the term "and/or" includes any and all
combinations of one or more of the associated listed items and may
be abbreviated as "/".
[0124] Spatially relative terms, such as "under", "below", "lower",
"over", "upper" and the like, may be used herein for ease of
description to describe one element or feature's relationship to
another element(s) or feature(s) as illustrated in the figures. It
will be understood that the spatially relative terms are intended
to encompass different orientations of the device in use or
operation in addition to the orientation depicted in the figures.
For example, if a device in the figures is inverted, elements
described as "under" or "beneath" other elements or features would
then be oriented "over" the other elements or features. Thus, the
exemplary term "under" can encompass both an orientation of over
and under. The device may be otherwise oriented (rotated 90 degrees
or at other orientations) and the spatially relative descriptors
used herein interpreted accordingly. Similarly, the terms
"upwardly", "downwardly", "vertical", "horizontal" and the like are
used herein for the purpose of explanation only unless specifically
indicated otherwise.
[0125] Although the terms "first" and "second" may be used herein
to describe various features/elements (including steps), these
features/elements should not be limited by these terms, unless the
context indicates otherwise. These terms may be used to distinguish
one feature/element from another feature/element. Thus, a first
feature/element discussed below could be termed a second
feature/element, and similarly, a second feature/element discussed
below could be termed a first feature/element without departing
from the teachings of the present invention.
[0126] Throughout this specification and the claims which follow,
unless the context requires otherwise, the word "comprise", and
variations such as "comprises" and "comprising" means various
components can be co-jointly employed in the methods and articles
(e.g., compositions and apparatuses including device and methods).
For example, the term "comprising" will be understood to imply the
inclusion of any stated elements or steps but not the exclusion of
any other elements or steps.
[0127] As used herein in the specification and claims, including as
used in the examples and unless otherwise expressly specified, all
numbers may be read as if prefaced by the word "about" or
"approximately," even if the term does not expressly appear. The
phrase "about" or "approximately" may be used when describing
magnitude and/or position to indicate that the value and/or
position described is within a reasonable expected range of values
and/or positions. For example, a numeric value may have a value
that is +/-0.1% of the stated value (or range of values), +/-1% of
the stated value (or range of values), +/-2% of the stated value
(or range of values), +/-5% of the stated value (or range of
values), +/-10% of the stated value (or range of values), etc. Any
numerical values given herein should also be understood to include
about or approximately that value, unless the context indicates
otherwise. For example, if the value "10" is disclosed, then "about
10" is also disclosed. Any numerical range recited herein is
intended to include all sub-ranges subsumed therein. It is also
understood that when a value is disclosed that "less than or equal
to" the value, "greater than or equal to the value" and possible
ranges between values are also disclosed, as appropriately
understood by the skilled artisan. For example, if the value "X" is
disclosed the "less than or equal to X" as well as "greater than or
equal to X" (e.g., where X is a numerical value) is also disclosed.
It is also understood that the throughout the application, data is
provided in a number of different formats, and that this data,
represents endpoints and starting points, and ranges for any
combination of the data points. For example, if a particular data
point "10" and a particular data point "15" are disclosed, it is
understood that greater than, greater than or equal to, less than,
less than or equal to, and equal to 10 and 15 are considered
disclosed as well as between 10 and 15. It is also understood that
each unit between two particular units are also disclosed. For
example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are
also disclosed.
[0128] Although various illustrative embodiments are described
above, any of a number of changes may be made to various
embodiments without departing from the scope of the invention as
described by the claims. For example, the order in which various
described method steps are performed may often be changed in
alternative embodiments, and in other alternative embodiments one
or more method steps may be skipped altogether. Optional features
of various device and system embodiments may be included in some
embodiments and not in others. Therefore, the foregoing description
is provided primarily for exemplary purposes and should not be
interpreted to limit the scope of the invention as it is set forth
in the claims.
[0129] The examples and illustrations included herein show, by way
of illustration and not of limitation, specific embodiments in
which the subject matter may be practiced. As mentioned, other
embodiments may be utilized and derived there from, such that
structural and logical substitutions and changes may be made
without departing from the scope of this disclosure. Such
embodiments of the inventive subject matter may be referred to
herein individually or collectively by the term "invention" merely
for convenience and without intending to voluntarily limit the
scope of this application to any single invention or inventive
concept, if more than one is, in fact, disclosed. Thus, although
specific embodiments have been illustrated and described herein,
any arrangement calculated to achieve the same purpose may be
substituted for the specific embodiments shown. This disclosure is
intended to cover any and all adaptations or variations of various
embodiments. Combinations of the above embodiments, and other
embodiments not specifically described herein, will be apparent to
those of skill in the art upon reviewing the above description. The
methods disclosed herein include certain actions taken by a
practitioner; however, they can also include any third-party
instruction of those actions, either expressly or by implication.
For example, actions such as "percutaneously stimulating an
afferent peripheral nerve" includes "instructing the stimulation of
an afferent peripheral nerve."
* * * * *