U.S. patent application number 15/674349 was filed with the patent office on 2017-11-23 for method and apparatus for noninvasive inhibition of deep vein thrombosis.
The applicant listed for this patent is StimMed LLC. Invention is credited to James Joseph Czymy, Scott E. Friedman, Robert Edward Kaplan.
Application Number | 20170333695 15/674349 |
Document ID | / |
Family ID | 57836440 |
Filed Date | 2017-11-23 |
United States Patent
Application |
20170333695 |
Kind Code |
A1 |
Kaplan; Robert Edward ; et
al. |
November 23, 2017 |
METHOD AND APPARATUS FOR NONINVASIVE INHIBITION OF DEEP VEIN
THROMBOSIS
Abstract
System, device and method for providing neuromuscular electrical
stimulation (NMES) to muscles of foot. The device includes an
electrical signal generator for producing a wave pattern of
variable frequency, duration, intensity, ramp time and on-off
cycle. The device further includes surface electrodes for being
positioned over the foot muscles or around ankles and attached to
the signal generator. The device includes a wearable device for
positioning a first electrode adjacent a heel of the wearer's foot
and a second electrode adjacent an arch of the foot. The signal
generator is programmed to stimulate the foot muscles and nerves.
Location of the electrodes and the programming are adjusted to
reduce pooling of the blood in the soleal veins of the calf and
enhance venous blood flow to prevent deep vein thrombosis (DVT); to
enhance venous blood flow for the post-thrombotic syndrome patient;
to expedite wound healing; to reduce neuropathic pain of the foot
and ankle, chronic musculoskeletal pain of the ankle and foot, and
acute post-operative foot and ankle pain; and to prevent muscular
atrophy of the foot muscles.
Inventors: |
Kaplan; Robert Edward;
(Buffalo, NY) ; Czymy; James Joseph; (Amherst,
NY) ; Friedman; Scott E.; (Amherst, NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
StimMed LLC |
Buffalo |
NY |
US |
|
|
Family ID: |
57836440 |
Appl. No.: |
15/674349 |
Filed: |
August 10, 2017 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
15287531 |
Oct 6, 2016 |
|
|
|
15674349 |
|
|
|
|
15204625 |
Jul 7, 2016 |
|
|
|
15287531 |
|
|
|
|
12687935 |
Jan 15, 2010 |
|
|
|
15204625 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/0452 20130101;
A61N 1/36021 20130101; A61N 1/0456 20130101; A61N 1/36003
20130101 |
International
Class: |
A61N 1/04 20060101
A61N001/04; A61N 1/36 20060101 A61N001/36 |
Claims
1. A wearable device for positioning a first electrode adjacent a
heel of a wearer's foot and a second electrode adjacent an arch of
the foot, comprising: a flexible support comprising: a bottom
portion configured to extend along a least a portion of the bottom
of the foot, posteriorly from an arch, and around the heel; an
ankle portion of the support configured to extend upwardly along
the back of the wearer's foot from the heel; a foot strap carried
by the support, configured to secure the bottom portion to the
bottom of the foot; an ankle strap carried by the support,
configured to secure the ankle portion to the wearer's ankle; a
heel electrode carried by the bottom portion; and an arch electrode
carried by the bottom portion.
2. A wearable device as in claim 1, wherein the bottom portion
comprises a central longitudinal axis, and at least a portion of
each of the heel electrode and arch electrode resides on both sides
of the axis.
3. A wearable device as in claim 2, wherein each of the heel
electrode and arch electrode has a geometric center and the
geometric centers are within 0.5 inches of the longitudinal
axis.
4. A wearable device as in claim 2, wherein the arch electrode has
a surface area of at least about 150% of the surface area of the
heel electrode.
5. A wearable device as in claim 2, wherein each of the heel
electrode and arch electrode has a geometric center and the
geometric centers are spaced apart along the axis by a distance
within the range of from about 3 inches to about 5 inches.
6. A wearable device as in claim 5, wherein the geometric centers
are spaced apart along the axis by a distance within the range of
from about 3.5 inches to about 4.5 inches.
7. A wearable device as in claim 1, wherein each of the heel
electrode and arch electrode further comprise a releasable
electrically conductive pad.
8. A wearable device as in claim 1, wherein the support comprises a
first surface for contacting the wearer and a second, opposing
surface, and further comprising at least two electrical connectors
on the second surface.
9. A wearable device as in claim 8, wherein the electrical
connectors comprise mechanical connectors for both mechanically and
electrically connecting to a removable control housing.
10. A wearable device as in claim 9, wherein the electrical
connectors are carried by the ankle portion of the support.
11. A wearable device as in claim 2, wherein the arch electrode has
a surface area of at least about 150% of the surface area of the
heel electrode.
12. A wearable device as in claim 2, wherein each of the heel
electrode and arch electrode intersects the axis.
13. A wearable device as in claim 2, wherein each of the heel
electrode and arch electrode has a transverse axis, extending at a
normal angle to the longitudinal axis, and the arch transverse axis
is at least about 150% the length of the heel transverse axis.
14. A wearable device as in claim 13, wherein arch transverse axis
is at least about 180% the length of the heel transverse axis.
15. A wearable device as in claim 13, wherein the heel transverse
axis is within the range of from about 1.5 inches to about 2.5
inches in length.
16. A wearable device as in claim 13, wherein the arch transverse
axis is within the range of from about 3 inches to about 5 inches
in length.
17. A wearable device as in claim 9, further comprising a control
carried by the electrical connectors.
Description
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS
[0001] This application is a continuation application of U.S.
patent application Ser. No. 15/287,531, filed on Oct. 6, 2016,
which a continuation-in-part application of U.S. patent application
Ser. No. 15/204,625, filed on Jul. 7, 2016, which is a continuation
of U.S. patent application Ser. No. 12/687,935, filed on Jan. 15,
2010, all of which are hereby incorporated by reference in their
entirety.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The present invention pertains generally to the field of the
electrical stimulation of muscles for prevention of thrombosis and
for pain management and, more particularly, to electrical
stimulation of muscles of the foot.
Description of the Related Art
[0003] Electrical stimulation of muscles and nerves by applying
electrodes over the skin is currently used for enhancing blood
circulation and reducing blood clots and for scrambling the pain
signal that reach the brain in order to manage pain.
[0004] Patients undergoing surgery, anesthesia and extended periods
of bed rest or other inactivity are often susceptible to a
condition known as deep vein thrombosis, or DVT. DVT is a clotting
of venous blood in the lower extremities or pelvis. This clotting
occurs due to the absence of muscular activity required to pump the
venous blood in the lower extremities, local vascular injury, or a
hypercoagulable state. The condition can be life-threatening if a
blood clot migrates to the lung, resulting in pulmonary embolism
(PE), or otherwise interferes with cardiovascular circulation. More
generally, venous thromboembolic disease (VTED) is a cause of
significant morbidity and mortality for individuals immobilized
after orthopedic surgery, due to neurologic disorders, even during
prolonged travel, and a variety of other conditions.
[0005] Since 1954, it has been known that prolonged dependency
stasis, a state imposed by airplane flights, automobiles trips and
even attendance at the theater may bring on thrombosis. In 1977, it
was shown that trips as short as three to four hours could induce
DVT and PE.
[0006] DVT and related conditions may be controlled or alleviated
by assisting blood circulation (venous return) in the muscles.
[0007] Current approaches to prophylaxis include mechanical
compression using pneumatic compression devices, anticoagulation
therapy and electrical stimulation of the muscles. Pneumatic
compression equipment is often too cumbersome for mobile patients,
or during prolonged travel. Anticoagulation therapy carries the
risk of bleeding complications and must be started several days in
advance to be effective. Electric stimulation has advantages over
the other two methods in that it can be started at the time
prophylaxis is needed and can be portable using DC current
sources.
[0008] A number of U.S. patents teach various methods of applying
electrical stimulation to the calf muscle for the prevention of
DVT. These include Powell, III, U.S. Pat. No. 5,358,513; Tumey,
U.S. Pat. No. 5,674,262; Dennis, III, U.S. Pat. No. 5,782,893;
Katz, U.S. Pat. No. 5,643,331; and Katz, U.S. Pat. No.
6,002,965.
[0009] U.S. Pat. No. 6,615,080 to Unsworth et al. provides a method
for preventing DVT, PE, ankle edema and venostasis and a device
that includes a single channel sequential neuromuscular electrical
stimulation (NMES) unit. The NMES unit is battery powered and can
be programmed to deliver a particular stimulus profile. In order to
simplify the patient's ability to properly apply the NMES device,
the stimulator generates biphasic symmetrical square wave pulses
with stimulus parameters demonstrated to result in optimum venous
blood flow. The stimulus profile included a stimulus frequency
fixed at 50 pulses per second, a stimulus duration of 300
microseconds, a ramp up time of 2 seconds, a ramp down time of 2
seconds, and a stimulus cycle set at 12 seconds on and 48 seconds
off. Once set in advance by the doctor, manufacturer or user, the
patient adjusts the intensity, using a stimulus intensity dial, to
the point needed to produce a minimally visible or palpable muscle
contraction. The output leads of the stimulator are attached
through a conductor to electrodes of various types including,
self-adherent surface electrodes. These electrodes are of opposite
polarity and create an electrical potential difference between
themselves and the tissue that separates them. The frequency and
electrical characteristics of electrical impulses applied to the
patient is referred to as the electrical stimulation routine.
[0010] In published but abandoned U.S. Patent Application
Publication No. 2006/0085047 A, a variation of Unsworth et al.
provided a method of automatically controlling the delivery of
single channel NMES of the plantar muscle, in response to the
sensing of motion of the foot or leg. In the published application,
the stimulation is turned off during walking or running to prevent
slips or falls and to reduce power consumption of the unit that
provides the stimulation.
[0011] FIG. 1A, FIG. 1B, FIG. 1C, FIG. 1D, and FIG. 1E show muscles
of the sole of a foot.
[0012] There are four layers of muscles in the sole of the foot.
After the skin of the plantar region and the fatty tissue have been
removed, an expansion of fibrous tissue known as the plantar fascia
is visible. If this is also taken away, the first layer of muscles
is exposed, consisting of abductor pollicis (14), flexor brevis
digitorum (18), and the abductor minimi digiti (16) (FIG. 1A). The
second layer, situated under the first, consists of the tendons of
the flexors longus digitorum (11), proprius, and pollicis (12). On
the outer side of the foot, the tendon of the peroneus longus (5)
passes beneath the flexor accessories (20). To complete the layer,
the muscles flexor accessorius (20) and the lumbricales (19) must
be named (FIG. 1B). The third plantar layer consists of the tendon
of tibialis posticus (10), the flexor brevis pollicis (15), the
adductor pollicis (21), the flexor brevis minimi digiti (17), and,
running across the foot, the transversus pedis (22). The sheath of
the peroneus longus (5), and the plantar ligament, are also found
in this layer (FIG. 1C). The fourth layer (FIG. 1F) consists of
three interossei (23), one on the inner side of the second toe, and
the others each on the inner side of the third and fourth toes.
[0013] They draw to the central line XY, called the "central
muscular action line," or the "line of muscular action." The first
layer (FIG. 1E) on the dorsal surface consists of the tendons of
the tibialis anticus (1), extensor proprius pollicis (2), extensor
longus digitorum (3), and the tertius peroneus (4). The muscles of
the extensor brevis digitorum (13), after passing under the
extensor longus digitorum (3), divide into four tendons, and aid in
the extension of the toes. The second layer (FIG. 1D) consists of
four interossei (23a), fixed on the outer side of the second,
third, and fourth toes and drawing from the "central muscular
action line" XY, and one on the inner side of the second toe
drawing to line XY.
[0014] Muscles of the foot are also divided into a plantar group
(internal, external, and central), which pertains to the sole of
the foot, and a dorsal group, which indicates the back muscles
behind the plantar muscles.
[0015] The dorsal group includes: [0016] 13. Extensor brevis
digitorum. First layer. [0017] 23a. Interossei dorsal (4). Second
layer.
[0018] The plantar group includes: [0019] 14. Abductor pollicis.
Internal first layer. [0020] 15. Flexor brevis pollicis. Internal
third layer. [0021] 16. Abductor minimi digiti. External first
layer. [0022] 17. Flexor brevis minimi digiti. External third
layer. [0023] 18. Flexor brevis digitorum. Central first layer.
[0024] 19. Lumbricales. Central second layer. [0025] 20. Flexor
accessorius. Central second layer. [0026] 21. Adductor pollicis.
Central third layer. [0027] 22. Transversus pedis. Central third
layer. [0028] 23. Interossei plantar (3). Fourth layer.
[0029] The location and function of each muscle is further
described below. [0030] 13. The extensor brevis digitorum arises in
the upper outer side of the heel-bone, and, broadening out, it
passes under the extensor longus digitorum, when it divides into
four tendons that go forward and are inserted in the bases of the
first phalanges. Its action is to aid the extension of the toes and
to counteract the tendency of obliquity of the extensor longus
digitorum. [0031] 14. The abductor pollicis arises on the inner
posterior region of the os calcis, and is inserted in the first
phalanx of the great toe. Its action is to abduct the big toe away
from the central line of the foot to the imaginary line that forms
the centre of the body. By this action, the great toes would be
brought closer together. [0032] 15. The flexor brevis pollicis
comes from the second row of the tarsus, and is inserted to the
base of the first phalanx. [0033] 16. The abductor minimi digiti
arises from the outside of the os calcis, and goes forwards to the
external side of the first phalanx of the little toe. Its action is
to draw the little toe away from the middle line of the foot.
[0034] 17. The flexor brevis minimi digiti has origin in the sheath
of the peroneus longus and the base of the fifth metatarsal bone,
and is inserted in the first phalanx of the little toe. Its action
is to flex the little toe. [0035] 18. The flexor brevis digitorum,
from the heel-bone and the plantar fascia, draws down the toes, and
is inserted in the second phalanges of the four toes. [0036] 19.
The four lumbricales are affixed to the inner side of the four
toes. Their action is to draw the toes into the inner side of the
foot. [0037] 20. The flexor accessorius extends from the os calcis
to the second, third, and fourth toes. In contraction, it
counteracts the obliquity of the flexor longus digitorum, hence its
name. [0038] 21. The adductor pollicis arises from the sheath of
the peroneus longus and the third and fourth metatarsals, and is
inserted in the first phalanx of the great toe on the outer side.
Its action is to adduct, or draw, the great toe to the central line
of the foot. [0039] 22. The transversus pedis goes across the foot,
and is inserted in the phalanx of the great toe. Its office is to
adduct, or draw, the big toe to the line of the foot termed the
"line of muscular action." [0040] 23. The three plantar interossei
are situated between the bones of the toes on the inner side, and
draw to the central line the three outer toes. [0041] 23a. The four
interossei, on the dorsal surface of the foot, are situated on the
outer side of the bones of the toes, and draw the third and fourth
toes away from the central line of muscular action. The two
interossei on either side of the second toe draw away from the axis
of the toe either to the outer or inner side of the foot,
respectively.
[0042] The foot is provided with two kinds of nerves--those that
supply the skin with sensory branches, and the other sort that give
motor impressions to the muscles. The posterior tibial and the
anterior tibial nerves come from the sciatic nerve, the former
giving branches to the muscles in passing down to the inner side of
the ankle. The posterior tibial then divides into external plantar
nerves and internal plantar nerves, that supply the toes and sole
of the foot. The anterior tibial nerves supply the dorsum of the
foot as well as the outer side of the leg.
[0043] Under the skin are found pads of fat, at the heel and toes
especially.
[0044] The muscles of the foot are further classified as either
intrinsic or extrinsic. The intrinsic muscles are located within
the foot and cause movement of the toes. These muscles are flexors
(plantar flexors), extensors (dorsiflexors), abductors, and
adductors of the toes. Several intrinsic muscles also help support
the arches of the foot. The extrinsic muscles are located outside
the foot, in the lower leg. The powerful calf muscle is among them.
Most of these muscles have long tendons that cross the ankle, to
attach on the bones of the foot and assist in movement.
[0045] FIG. 2 shows the flexor digitorum brevis muscle.
[0046] This muscle is responsible for flexing the four smaller
toes. It lies in the middle of the sole of the foot, immediately
above the central part of the plantar aponeurosis, with which it is
firmly united. Its deep surface is separated from the lateral
plantar vessels and nerves by a thin layer of fascia. It arises by
a narrow tendon, from the medial process of the tuberosity of the
calcaneus, from the central part of the plantar aponeurosis, and
from the intermuscular septa between it and the adjacent muscles.
It passes forward, and divides into four tendons, one for each of
the four lesser toes.
[0047] Of the other muscle of the first layer, the abductor digiti
minimi (abductor minimi digiti, abductor digiti quinti) is a muscle
which lies along the lateral border of the foot, and is in relation
by its medial margin with the lateral plantar vessels and nerves.
Its function is to flex and abduct the fifth (little) toe. The last
muscle of the first layer, abductor pollicis is like the abductor
digiti minimi except that it lies along the lateral inside border
of the foot and connects to the big toe.
[0048] FIG. 3A and FIG. 3B show placement of electrodes as
disclosed by Unsworth et al., U.S. Pat. No. 6,615,080.
[0049] FIG. 3A illustrates a sole of a foot 31. Toes 32, ball 33,
arch 34, and heel 35 are shown in the drawing. Electrodes 36a, 36b
are located in an area over intrinsic muscles on the plantar
surface of the foot, or proximal to them, for example on or around
the ball of the foot 33, and over or proximal to the heel 35. In
FIG. 3A, electrodes 36a and 36b are placed that deliver the
electrical impulses generated by the NMES device 30. FIG. 3B shows
an alternate area 36a' at which an electrical impulse can be
delivered. In some embodiments of the Unsworth invention, the
electrode 36a occupies only the area of the ball of the foot, while
other embodiments include elliptical electrodes having their major
axis normal to the longitudinal axis of the foot 31.
[0050] As shown in FIG. 3A and FIG. 3B, the Unsworth issued patent
applies one electrode over or proximal to the heel and the other
over the intrinsic muscles on the plantar surface of the foot, for
example, on or around the ball of the foot. In Unsworth, the
intensity of the electrical stimulation required is only that
necessary to create a slight visible muscle twitch of the foot
muscles, or a minimally visible or palpable muscle contraction. By
stimulating in this manner, blood pooling in the calf veins was
prevented.
[0051] Electrical stimulation is also utilized for pain management.
The most common form of electrical stimulation used for pain
management is transcutaneous electrical nerve stimulation (TENS)
therapy, which provides short-term pain relief. Electrical nerve
stimulation and electrothermal therapy are used to relieve pain
associated with various conditions, including back pain. For
example, intradiscal electrothermal therapy (IDET) is a treatment
option for people with low back pain resulting from intervertebral
disc problems. In TENS therapy for pain management, a small,
battery-operated device delivers low-voltage electrical current
through the skin via electrodes placed near the source of pain. The
electricity from the electrodes stimulates nerves in the affected
area and sends signals to the brain that "scramble" normal pain
perception. TENS is not painful and has proven to be an effective
therapy to mask pain.
SUMMARY OF THE INVENTION
[0052] Aspects of the present invention provide systems, devices,
and methods for providing neuromuscular electrical stimulation
(NMES) to muscles of the foot. One aspect provides a single channel
stimulator device that includes an electrical signal generator for
producing a wave pattern of variable frequency, duration,
intensity, ramp time, and on-off cycle. The stimulator device
further includes surface electrodes for being positioned over the
foot muscles and attached to the signal generator. The signal
generator is programmed to stimulate the foot muscles. The
programming is adjusted to reduce pooling of the blood in the
soleal veins of the calf and enhance venous blood flow to prevent
DVT, to enhance venous blood flow for the post-thrombotic syndrome
patient, to expedite wound healing, to reduce neuropathic pain of
the foot and ankle, chronic musculoskeletal pain of the ankle and
foot, and acute post-operative foot and ankle pain, and to prevent
muscular atrophy of the foot muscles.
[0053] In some aspects of the present invention, the electrodes are
arranged on the heel and the mid-section or arch of the foot. This
arrangement is appropriate for systems, devices, and methods of the
present invention that contribute to (1) enhanced venous blood flow
to prevent DVT, (2) enhanced venous blood flow for the
post-thrombotic syndrome patient, and (3) prevention of muscular
atrophy of the foot muscles.
[0054] As FIG. 3A and FIG. 3B of the drawings show, in Unsworth,
one electrode is located on the heel while the second electrode
targets the ball of the foot.
[0055] Aspects of the present invention place the second electrode
in the arch of the foot. This location targets the flexor digitorum
brevis muscle. This muscle is the largest muscle; it is close to
the skin and is separated from the lateral plantar vessels and
nerves by a thin layer of fascia, and it is responsible for flexing
the four smaller toes. Because it is a larger muscle, it generates
more circulation when it is stimulated, and because it is closer to
the skin, it is more accessible by the electrode. Moreover, one end
of this muscle is located at the heel, and the electrical pulse may
be conducted through the length of the muscle and the nerves that
control it.
[0056] The ball of the foot and its vicinity are separated from the
skin with a thicker layer of fat, and the skin is generally more
calloused in that area. The arch of a normal foot is seldom
calloused and has a relatively thin skin. Moreover, the lumbricals,
which are located under the ball, lie in the second layer of foot
muscles, which is located deeper and further from the skin.
Lumbricals are much smaller than the flexor digitorum brevis and
control the same 4 small toes. Except, the motion generated by the
lumbricals is an adduction motion, which is not as extensive as a
flexing motion, and generally would not generate as much
circulation.
[0057] The electrodes are located on the heel and the bottom of the
mid-foot region or the arch. The active electrode is located at the
mid-foot region, and the ground electrode is located at the
heel.
[0058] Aspects of the present invention further provide systems,
devices, and methods that contribute to (1) enhanced wound healing,
(2) reduction of the neuropathic pain of the foot and ankle, (3)
reduction of the chronic musculoskeletal pain of the ankle and
foot, and (4) reduction of the acute post-operative foot and ankle
pain. These aspects of the present invention provide pain relief by
generating a tapping feeling that results from intermittent
electrical stimulation of the muscle. For reduction of neuropathic
pain, chronic musculoskeletal pain, acute post-op pain, and wound
healing, the electrodes are placed at the level of the main ankle
bones called the medial malleolus and the lateral malleolus. For
both electrodes, the connection site would be just below the
malleolus. For other indications, the electrodes are located on the
sole of the foot.
[0059] Aspects of the present invention provide a device for
delivering electrical stimulation to muscles of a foot of a
patient. The device includes one or more power sources, a signal
generator for generating electrical current, and electrodes in
communication with the signal generator for delivery of the
electrical current to the foot. The electrical current is for
causing the muscles to contract, and the electrodes are adapted to
be located on a heel of the foot and on an arch of the foot.
[0060] Aspects of the present invention provide a device for
delivering electrical stimulation to muscles of a foot of a
patient. The device includes one or more power sources, a signal
generator for generating electrical current, and electrodes in
communication with the signal generator for delivery of the
electrical current to the foot. The electrical current is for
disturbing pain signals communicated by the muscles to brain, and
the electrodes are connected anteriorly to ankle to stimulate
peroneal nerve of the foot. The electrodes may be adapted to be
located at two or more of medial ankle at location of posterior
tibial nerve, lateral ankle at location of sural nerve, and
anterior ankle at location of anterior tibial nerve.
[0061] Aspects of the present invention provide a method for
enhancing venous blood flow to prevent deep vein thrombosis,
enhancing venous blood flow for post-thrombotic syndrome patients,
and preventing muscular atrophy of foot muscles. The method
includes connecting electrodes to a foot of the patient, and
applying electrical current of a programmable waveform, intensity,
frequency, and duration to the foot muscles through the electrodes.
A ground electrode is connected to a heel of the foot, and a
positive electrode is connected to an arch of the foot.
[0062] Aspects of the present invention provide a method for
enhancing wound healing, reducing neuropathic pain of the foot and
ankle, reducing chronic musculoskeletal pain of the ankle and foot,
and reducing acute post-operative foot and ankle pain. The method
includes connecting electrodes to a foot of the patient, and
applying electrical current of a programmable waveform, intensity,
frequency, and duration to the foot muscles through the electrodes.
The electrodes are connected anteriorly to the ankle to stimulate
peroneal nerve of the foot. The electrodes may be connected at two
or more of just below the medial malleolus at posterior tibial
nerve, at lateral malleolus at sural nerve, and at anterior ankle
at anterior tibial nerve.
[0063] Aspects of the present invention provide a wearable device
for positioning a first electrode adjacent a heel of a wearer's
foot and a second electrode adjacent an arch of the foot,
comprising 1) a flexible support having a bottom portion configured
to extend along a least a portion of the bottom of the foot,
posteriorly from an arch, and around the heel; 2) an ankle portion
of the support configured to extend upwardly along the back of the
wearer's foot from the heel; 3) a foot strap carried by the
support, configured to secure the bottom portion to the bottom of
the foot; 4) an ankle strap carried by the support, configured to
secure the ankle portion to the wearer's ankle; 5) a heel electrode
carried by the bottom portion; and 6) an arch electrode carried by
the bottom portion. In other aspects of the present invention, the
wearable device may further comprise a control carried by the
electrical connectors.
[0064] In some aspects of the present invention, the bottom portion
may comprise a central longitudinal axis, and at least a portion of
each of the heel electrode and the arch electrode may reside on
both sides of the axis. Each of the heel electrode and the arch
electrode may intersect the central longitudinal axis.
[0065] In some aspects of the present invention, each of the heel
electrode and the arch electrode may have a geometric center that
is within about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 1.0, or 1.5
inches of the longitudinal axis. In one aspect of the present
invention, the geometric centers of the heel electrode and the arch
electrode may be within 0.5 inches of the longitudinal axis.
[0066] In some aspects of the present invention, the arch electrode
may have a surface area of at least about 25%, 50%, 100%, 150%,
200%, 250%, 300%, 400%, 500%, or 600% of the surface area of the
heel electrode. In one aspect of the present invention, the arch
electrode may have a surface area of at least about 150% of the
surface area of the heel electrode.
[0067] In other aspects of the present invention, each of the heel
electrode and the arch electrode has a geometric center and the
geometric centers are spaced apart along the longitudinal axis by a
distance within the ranges of from about 3.5 inches to about 4.5
inch, or from about 3 inch to about 5 inches. In one aspect of the
present invention, the spacing between the geometric centers of the
heel electrode and the arch electrode is approximately 4
inches.
[0068] In other aspects of the present invention, each of the heel
electrode and the arch electrode may further comprise a releasable
electrically conductive pad positioned to contact the foot of the
wearer.
[0069] In yet another aspect of the present invention, the support
may comprise a first surface for contacting the patient and a
second, opposing surface, and further comprising at least two
electrical connectors on the second surface. The electrical
connectors may comprise mechanical connectors for both mechanically
and electrically connecting to a control. Further, the electrical
connectors may be carried by the ankle portion of the support.
[0070] In some aspects of the present invention, each of the heel
electrode and the arch electrode may have a transverse axis,
extending at a normal angle to the longitudinal axis. The length of
the arch transverse axis may be at least about 50%, 100%, 150%,
180%, 200%, 250%, 300%, 400%, or 500% of the length of the heel
transverse axis. In one aspect of the present invention, the arch
transverse axis is at least about 150% the length of the heel
transverse axis. In another aspect of the present invention, the
arch transverse axis may be at least about 180% the length of the
heel transverse axis.
[0071] In some aspects of the present invention, the heel
transverse axis is within the range of from about 1.5 inches to
about 2.5 inch, from about 1.0 inch to about 3.0 inches, or from
about 0.5 inches to about 3.5 inches. In one aspect of the present
invention, the heel transverse axis is within the range of from
about 1.5 inches to about 2.5 inches in length.
[0072] In other aspects of the present invention, the arch
transverse axis is within the range of from about 3.5 inches to
about 4.5 inch, from about 3 inch to about 5 inches, from about 2.5
inches to about 5.5 inches, from about 2 inches to about 6 inches.
In one aspect of the present invention, the arch transverse axis is
within the range of from about 3 inches to about 5 inches in
length.
BRIEF DESCRIPTION OF THE DRAWINGS
[0073] FIGS. 1A, 1B, 1C, 1D, 1E and 1F show muscles of the sole of
a foot.
[0074] FIG. 2 shows the flexor digitorum brevis muscle.
[0075] FIG. 3A and FIG. 3B show placement of electrodes as
disclosed by Unsworth et al., U.S. Pat. No. 6,615,080.
[0076] FIG. 4 shows a device for providing electrical stimulation
to the foot, according to aspects of the present invention.
[0077] FIG. 5 shows placement of electrodes on the foot, according
to aspects of the present invention.
[0078] FIGS. 6A, 6B, and 6C show placement of electrodes on the
foot for pain management, according to further aspects of the
present invention.
[0079] FIG. 7 shows a flowchart of a method of increasing
circulation, according to aspects of the present invention.
[0080] FIG. 8 shows a flowchart of a method of pain management,
according to aspects of the present invention.
[0081] FIG. 9 shows a device for providing electrical stimulation
to the foot, according to aspects of the present invention.
[0082] FIG. 10 shows an exploded perspective view of a wearable
device for positioning a first electrode adjacent a heel of a
patient's foot and a second electrode adjacent an arch of the foot,
according to aspects of the present invention.
[0083] FIGS. 11 and 12 show inside and outside plan views,
respectively, of a wearable device, according to aspects of the
present invention.
[0084] FIG. 13 shows an inside view of an inside cover of a
wearable device, according to aspects of the present invention.
[0085] FIG. 14 shows an electrically conductive circuit image of a
wearable device, according to aspects of the present invention.
[0086] FIG. 15 shows a control that generates and modulates
electrical stimulation, according to aspects of the present
invention.
[0087] FIGS. 16A, 16B, and 16C show exemplary waveforms of
electrical stimulation generated from a control, according to
aspects of the present invention.
[0088] FIGS. 17A, 17B, and 17C show a procedure of attaching
electrically conductive pads to a wearable device, according to
aspects of the present invention.
[0089] FIGS. 18A, 18B, 18C, 18D, 18E, and 18F show a procedure of
mounting a wearable device and a control on a wearer's foot,
according to aspects of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0090] Aspects of the present invention provide an improved system,
device, and method of administering electrical stimulation to the
muscles of the foot.
[0091] Aspects of the present invention provide a programmable
electrical pulse generator for delivering an electrical current of
mild and tolerable intensity to the muscles of the foot, which
results in a mild contraction of the muscles. In various aspects of
the present invention, the contraction may be accomplished by
placing surface electrodes on the soles of the feet or at the
ankles. When placed on the soles, the active surface electrodes are
placed over the larger muscles of the first layer that are closer
to the surface of the skin and in an area where callousing of the
skin and the fat layer is minimal such as the mid-foot and arch
area. The ground electrodes may be placed over or proximal to the
heel. By stimulating the foot muscles in this manner, blood pooling
in the calf veins is prevented. When placed on the side or top of
the ankles, the surface electrodes stimulate the posterior tibial,
the anterior tibial, or the sural nerves. By stimulating the
peripheral nerves with the arrangement of electrodes around the
ankles, pain management and improved wound healing may be
achieved.
[0092] FIG. 4 and FIG. 9 show a device for providing electrical
stimulation to the foot, according to aspects of the present
invention.
[0093] The device 400 includes a generator 410, connecting wires
410, and electrodes 430 and 435. The electrodes are connected to
the generator via the connecting wires. The generator 410 is a
programmable electrical stimulation signal generation device. The
electrodes 430 and 435 may be interchangeable and their polarity is
determined according to their connection to the generator 410. The
electrodes are self adhesive or otherwise attachable to skin.
[0094] Various aspects of the present invention may be implemented
in footwear and accessories to footwear such as shoes, socks, and
stockings. They may be carried in a pocket or pouch in an item of
footwear, with conductors connecting the stimulus generating
portion of the device to electrodes placed on the skin. The
electrodes may vary in shape and size and may be self-adhering of
the type utilized for TENS devices. Moreover, if at least one of
the electrodes includes a power source, then the electrodes may be
wirelessly in communication with the signal generator. In that
situation, the signal generator may be located closer to the hands
and head of the user, allowing him to more easily adjust the
intensity and other parameters of the stimulation. In the case of
wireless control, the electrodes must be connected together,
outside the body, to create a closed circuit with the passage
through the muscles. Further, the signal generator may be remotely
programmable by a physician monitoring the patient.
[0095] FIG. 5 shows placement of electrodes on the foot, according
to aspects of the present invention.
[0096] The electrodes 430 and 435 are located on the foot 31 such
that one electrode attaches to the heel, and the other is attached
to the mid-section or the big arch of the foot. In the arch area,
the skin is not calloused, and the fat layer under the skin is
minimal. In one aspect, the heel electrode 430 is the ground
electrode, and the arch electrode is the active or positive
electrode.
[0097] FIGS. 6A, 6B and 6C show placement of electrodes on the
ankles, according to aspects of the present invention.
[0098] The placement of the ankle electrodes is chosen to optimally
stimulate the posterior tibial, anterior tibial, and sural nerves
of the leg 50. This in turn will provide the maximum therapeutic
effect for pain management, enhancing wound healing, and preventing
muscle atrophy. These electrodes may be located at the area of the
peroneal motor nerve, which is also referred to as the anterior
tibial nerve. In one aspect, the electrodes would be placed just
lateral to the tendon of tibialis anterior and just proximal to the
malleoli. FIG. 6B provides the ankle showing anterior electrode
placement (435) and lateral electrode placement (430). FIG. 6C
provides a line drawing of the ankle showing anterior electrode
placement (435) and medial electrode placement (430).
[0099] FIG. 7 shows a flowchart of a method of increasing
circulation, according to aspects of the present invention.
[0100] The method begins at 701. At 702, one electrode, for example
the ground electrode, is connected to heel of a foot. At 703, the
other electrode, for example the active electrode, is connected to
a mid-section or arch of the foot. At 704, electrical stimulation
is applied to the muscles of the foot through the attached
electrodes. At 705, the method ends.
[0101] In variations of this method, the electrical stimulation may
be periodically or continuously adjusted according to readout of
parameters from the patient or according to decision of a physician
or the patient himself.
[0102] FIG. 8 shows a flowchart of a method of pain management,
according to aspects of the present invention.
[0103] The method begins at 801. At 802, one electrode, for example
the ground electrode, is connected above the ankle of a foot. At
803, the other electrode, for example the active electrode, is
connected to below the ankle of the foot. At 804, electrical
stimulation is applied to the muscles of the foot through the
attached electrodes. At 805, the electrical stimulation is
adjusted. At 806, the method ends.
[0104] Aspects of the present invention provide a wearable device
for positioning a first electrode adjacent a heel of the wearer's
foot and a second electrode adjacent an arch of the foot. FIG. 10
shows an exploded perspective view of the wearable device 1000,
according to aspects of the present invention.
[0105] The wearable device 1000 comprises an outside cover 1002, an
inside cover 1050, and a circuit 1070. The inside cover 1050 is
configured to contact the wearer's foot. FIGS. 11 and 12 show
inside and outside views, respectively, of the wearable device
1000, according to aspects of the present invention. FIG. 13 shows
an inside view of the inside cover 1050 of the wearable device
1000. FIG. 14 shows an image of the circuit 1070 of the wearable
device 1000, according to aspects of the present invention.
[0106] Referring to FIGS. 10 and 12, the outside cover 1002
comprises a bottom portion 1004 and an ankle portion 1006. The
bottom portion 1004 may be configured to extend along a least a
portion of the bottom of the foot, posteriorly from an arch, and
around the heel. The ankle portion 1006 may extend upwardly along
the back of the wearer's foot from the heel. At least a portion of
the outside cover 1002 is flexible such that it can extend along a
least a portion of the bottom of the foot, posteriorly from an
arch, around the heel, and/or upwardly along the back of the foot
from the heel.
[0107] The outside cover 1002 may further comprise a foot strap
1008 and an ankle strap 1010. The foot strap 1008 secures the
bottom portion 1004 to the bottom of the wearer's foot. The foot
strap 1008 may extend around the middle of the foot to secure the
bottom portion 1004 of the outside cover 1002 to the bottom of the
foot. The ankle strap 1010 secures the ankle portion 1006 to the
wearer's ankle. The ankle strap 1010 may extend in one or both
directions to surround the ankle to secure the ankle portion 1006
of the outside cover 1002 to the ankle.
[0108] In the illustrated embodiment, the foot strap 1008 comprises
a first wing 1012 and an opposing second wing 1014 for extending
around the wearer's foot. Each end of the foot strap wings 1012,
1014 may have foot strap fasteners 1016, 1618 to hold the two ends
of the foot strap 1008 together. After the wearer places the foot
strap 1008 around the middle of the foot, the wearer can use
fasteners 1016, 1618 to hold the two ends of the strap together and
keep the foot strap 1008 around the middle of the foot. The
fasteners 1016, 1618 may be complementary structures such as
interlocking loop and hook, snaps, buttons, adhesive, buckles,
tri-glides, locks, rings, hooks or, sliders. For a foot strap 1008
without fasteners 1016, 1018, the wearer may tie a knot with the
two ends of the foot strap 1008, or the foot strap 1008 may be a
continuous strap optionally comprising an elastic material.
[0109] Similarly, two opposing wings 1020, 1022 of the ankle strap
1010 may each have complementary ankle strap fasteners 1024, 1026
to hold the ends of the ankle strap wings 1020, 1022 together.
After the wearer places the ankle strap 1010 around the ankle, the
wearer can use fasteners 1024, 1026 to hold the two ends of the
strap together and keep the ankle strap 1010 around the ankle. The
fasteners 1024, 1026 may be complementary structures such as
interlocking loop and hook, snaps, buttons, adhesive, buckles,
tri-glides, locks, rings, hooks or, sliders. For an ankle strap
1010 without fasteners 1024, 1026, the wearer may tie a knot with
the two ends of the ankle strap 1010, or the ankle strap 1010 may
be a continuous strap optionally comprising an elastic
material.
[0110] The outside cover 1002 may further comprise an extender
strap 1028. The extender strap 1028 may be attached to the foot
strap 1008 or the ankle strap 1010 of the outside cover 1002. The
extender strap 1028 extends the length of the foot strap 1008 or
the ankle strap 1010 such that the foot strap 1008 or the ankle
strap 1010 extends around the full circumference of the middle of
the foot or the ankle, respectively. The extender strap 1028 may
comprise a fastener 1034 configured such that its first end 1030 is
fastened to a first end of the wings 1012, 1014 of the foot strap
1008 or the wings 1020, 1022 of the ankle strap 1010. The fastener
1034 may be configured to hold together its second, opposing end
1032 and the second, opposing end of the wings 1012, 1014 of the
foot strap 1008 or the wings 1020, 1022 of the ankle strap
1010.
[0111] The inside cover 1050 is attached to the inside of the
outside cover 1002. The outside surface of the inside cover 1050 is
configured to abut the inside surface of the outside cover 1002 and
may be secured by stitching, adhesives, heat bonding or other
techniques. The inside surface of the inside cover 1050 is
configured to touch the skin of the wearer's foot.
[0112] Referring to FIG. 13, the inside cover 1050 comprises a
bottom portion 1054 and an optional ankle portion 1056. The bottom
portion 1054 of the inside cover 1050 is attached to the bottom
portion 1004 of the outside cover 1002. The bottom portion 1054 of
the inside cover 1050 has two apertures 1060, 1062 on or near the
central longitudinal axis of the inside cover 1050.
[0113] Referring to FIG. 11, electrically conductive pads 1064,
1066 may be removably placed in contact with the electrodes 1074,
1076 and exposed through the two apertures of the inside cover
1050. The electrically conductive pads 1064, 1066 are positioned
over the foot muscles and may be electrically and/or mechanically
connected to the electrodes 1074, 1076 of the circuit 1070. The
first aperture 1060 (arch aperture) is located near an arch of the
wearer's foot, and the first electrically conductive pad 1064 (arch
pad) may be placed in the arch aperture 1020. The second aperture
1062 (heel aperture) is located near a heel of the foot, and the
second electrically conductive pad 1066 (heel pad) may be placed in
the heel aperture 1022.
[0114] When attached to the electrodes 1074, 1076 of the circuit
1070, the electrically conductive pads 1064, 1066 are electrically
connected to the electrodes 1074, 1076. When touching the skin of
the foot, the pads 1064, 1066 electrically connected to the
wearer's foot. The pads 1064, 1066 comprise a support layer and may
further comprise a protective film on each side of the pads. The
pads 1064, 1066 may further comprise electrically conductive gel to
enhance their electrical conductivity. The outside surfaces of the
pads 1064, 1066 may be covered by adhesive so that the pads 1064,
1066 are removably attached to the electrodes. The inside surfaces
of the electrically conductive pads 1064, 1066 touch the skin of
the wearer's foot when the wearable device 1000 is worn. Electrical
stimulation conducts from the electrodes 1074, 1076 to the wearer's
foot via the pads 1064, 1066. For a wearable device 1000 without
pads 1064, 1066, electrical stimulation may directly conduct from
the electrodes 1074, 1076 to the foot.
[0115] The ankle portion 1056 of the inside cover 1050 is attached
to the ankle portion 1006 of the outside cover 1002.
[0116] The circuit 1070 (FIG. 10) is positioned between the outside
cover 1002 and the inside cover 1050 and conducts electricity from
a control, which generates electrical stimulation, to the wearer's
foot. The circuit 1070 comprises first and second connectors 1072,
arch electrode 1074, heel electrode 1076, and conductors 1078 such
as wired or conductive traces. Optionally, the electrically
conductive pads 1064, 1066 are electrically connected to the
control via the circuit 1070.
[0117] The connectors 1072 electrically connect the control with
the circuit 1070. The circuit 1070 is made out of electrically
conductive materials. The connectors 1072 may be located on the
outside surface of the outside cover 1002 or the inside surface of
the inside cover 1050.
[0118] The connectors 1072 may electrically or both electrically
and mechanically connect the control with the circuit 1070. The
control may removably attach to the connectors 1072. The connectors
1072 may be one or more snaps, clips, slides, pins, or others known
in the art.
[0119] In addition to first and second connectors 1072, one or two
or more additional connectors 1073 maybe provided for additional
electrical and or mechanical connection to a control. In the
illustrated embodiment, first and second connectors 1072 are
configured to both electrically and mechanically removably connect
to the housing of the control. Additional mechanical integrity is
provided by the third connector 1073 which mechanically releasably
connects to the housing of the control. See also FIG. 12.
[0120] Referring to FIG. 14, each of the arch electrode 1074 and
the heel electrode 1076 may comprise a flexible, conductive foil.
The conductive foil may comprise silver. The arch electrode 1074 is
placed adjacent to the first aperture 1060 of the inside cover 1050
near an arch of the foot. The heel electrode 1076 is placed
adjacent to the second aperture 1062 of the inside cover 1050 near
a heel of the wearer's foot. The electrically conductive pads 1064,
1066 may be removably attached to the arch electrode 1074 and the
heel electrode 1076.
[0121] The wires 1078 electrically connect the connectors 1072 with
the arch electrode 1074 and the heel electrode 1076. The wire 1078
may comprise a conductive foil. Insulator 1080 is placed around the
wires 1078 and electrically insulates the wires to prevent unwanted
electrical leak from the wires 1078. It is desirable that
electricity is conducted from the control to the circuit 1070 only
via the connectors 1072, and electricity is conducted from the
circuit 1070 to the skin of the foot only via the arch electrode
1074 and the heel electrode 1076. Protector 1082 is placed around
the wires 1078 near the connectors 1072 and protects the wires 1078
from load, tension, stress, physical fatigue, or failure. The
protector 1082 may be composed of materials whose stiffness is
higher than that of the wires 1078. The protector 1082 may also be
composed of insulating materials. The protector 1082 may be
composed of the same materials as the insulator 1080.
[0122] FIG. 15 shows a control 1500 for controlling administration
of electrical stimulation. The control 1500 generates electrical
stimulation signal, which is conducted to the wearer's foot via the
connectors 1072, the wires 1078, the electrodes 1074, 1076, and,
optionally, the removable pads 1064, 1066. The control 1500 may
produce an intermittent signal pattern such as a square wave
pattern of variable frequency, duration, intensity, ramp time, and
stimulation on-off cycle. The control 1500 is programmed in a
manner to stimulate the target muscles to reduce pooling of the
blood in the soleal veins of the calf. While wearing the wearable
device 1000, the wearer may modulate one or more characteristics of
electrical impulses applied to the wearer, including the frequency,
duration, intensity, ramp time, and on-off cycle of the electrical
stimulation by operating the control 1500. Alternatively, the
control 1500 may be preprogrammed or programmed once during an
initial setup process.
[0123] In one aspect of the present invention, the control 1500 may
comprise a power controller 1502 and a stimulation adjuster 1504.
The power controller 1502 turns the control 1500 on and off. The
power controller 1502 may be one or more buttons, keypads,
switches, dials, slides, or levers. The stimulation adjuster 1504
controls one or more the characteristics of the electrical
stimulation, including the frequency, duration, intensity, ramp
time, and on-off cycle. The stimulation adjuster 1504 may be one or
more buttons, keypads, switches, dials, slides, or levers. The
control 1500 may further comprise a display screen 1506, which
shows the characteristics of the electrical stimulation as the
stimulation is adjusted by the stimulation adjuster 1504. The
display screen 1506 may go to sleep after a certain period of
inactivity. In another aspect of the present invention, the control
1500 may further comprise a power indicator 1508 and a stimulation
indicator 1510. The power indicator 1508 indicates whether the
power of the control 1500 is on or off. The power indicator 1508
may be a speaker, a light bulb, a LED, a display, a vibrator, or a
motor. The stimulation indicator 1510 indicates whether the control
1500 is generating electrical stimulation. The stimulation
indicator 1508 may be a speaker, a light bulb, a LED, a display, a
vibrator, or a motor.
[0124] In one aspect of the present invention, the maximum or peak
stimulation intensity may be between about 20 mA and about 40 mA
and in one implementation is about 30 mA. The maximum frequency of
the electrical stimulation may be between about 40 Hz and about 60
Hz and in one implementation is about 50 Hz. The maximum or peak
voltage may be about 133V DC, and the maximum impedance may be
about 5 k.OMEGA.. One example of stimulation signal pattern type
may be a constant current, biphasic pulse. Constant current means
that as the impedance of the control 1500 increases, the voltage of
the control 1500 increases in order to maintain the set current.
This only happens as long as the voltage is less than the maximum
voltage. The output electrical stimulation is determined according
to the following equation: V=IZ, where V is the voltage, I is the
current, and Z is the impedance of the control 1500.
[0125] In one aspect of the present invention, the duration of each
cycle of the electrical stimulation may be about 300 microseconds
(or about 150 microseconds per phase). The positive and negative
phases of the electrical stimulation may be symmetrical to each
other. If there is any asymmetry between the phases, such asymmetry
is preferably less than 10% difference in area. The electrical
asymmetry between the phases may result in electrical charge
accumulation on one of the electrically conductive pads 1064, 1066
or the electrodes 1074, 1076 after each cycle of the electrical
stimulation (or each pair of stimulation phases).
[0126] FIGS. 16A, 16B, and 16C show exemplary waveforms of
electrical stimulation generated from the control 1500. Referring
to FIG. 16A, the waveform output generated from the control 1500 is
biphasic with 12 seconds of 50 Hz stimulation followed by 48
seconds of rest. The intensity of the electrical stimulation may
change according to the one-minute cycle that includes 2 seconds of
ramping up, 8 seconds of constant set intensity, 2 seconds of
ramping down, and 48 seconds of rest. If the intensity of the
electrical stimulation is increased, the change in the output
waveform will be as shown in FIG. 16B. If the intensity of the
stimulation is decreased, the change in the output waveform will be
as shown in FIG. 16C.
[0127] Before wearing the wearable device 1000, the wearer may
clean the area of the foot where the pads 1064, 1066 or the
electrodes 1074, 1076 will be placed in order to allow good contact
and to help prevent skin irritation. The wearer may use a mild soap
and water to wash the skin of the foot before placing the pads
1064, 1066 or the electrodes 1074, 1076 on the skin to improve
adhesion. It is preferred that the wearer applies the pads 1064,
1066 or the electrodes 1074, 1076 to clean, unbroken skin.
[0128] FIGS. 17A, 17B, and 17C show a procedure of attaching the
releasable electrically conductive heel pad 1066 (second
electrically conductive pad) to the wearable device 1000. Referring
to FIG. 17A, the wearer may peel the heel pad 1066 from the
protective film on one side of the pad 1066. The wearer may
alternatively peel the protective film from one side of the heel
pad 1066. Referring to FIG. 17B, the wearer may then place the heel
pad 1066 in the heel aperture 1022 (second aperture) of the inside
cover 1050. Referring to FIG. 17C, the wearer may then peel the
protective film from the foot contacting side of the heel pad 1066.
The wearer may place the arch pad 1064 (first electrically
conductive pad) to the wearable device 1000 in a similar fashion as
described above.
[0129] FIGS. 18A, 18B, 18C, 18D, 18E, and 18F show a procedure of
mounting the wearable device 1000 and the control 1500 on the
wearer's foot. This procedure may occur after applying the
electrically conductive pads 1064, 1066 to the wearable device
1000. Referring to FIGS. 18A and 18B, the wearer may step on the
wearable device 1000 or place the wearable device 1000 on the
wearer's foot. The wearer may place the arch pad 1064 attached to
the wearable device 1000 near the arch of the wearer's foot and
then place the heel pad 1066 attached to the wearable device 1000
near the heel of the wearer's foot. The wearer may alternatively
place the heel pad 1066 near the heel of the wearer's foot and then
place the arch pad 1064 near the arch of the wearer's foot. FIG.
18C shows where the arch pad 1064 and the heel pad 1066 may be
placed on the wearer's foot.
[0130] Referring to FIG. 18D, the wearer may wrap the foot strap
wings 1012, 1014 of the foot strap 1008 of the wearable device 1000
around the wearer's foot. The wearer may optionally use the foot
strap fasteners 1016, 1618 to hold the two ends of the foot strap
1008 together. Referring to FIG. 18E, the wearer may attach the
control 1500 to the wearable device 1000 using the connectors 1072
and optionally the additional connectors 1073. The wearer may
attach the control 1500 to the wearable device 1000 before or after
placing the electrically conductive pads 1064, 1066 to the wearable
device 1000. The wearer may attach the control 1500 to the wearable
device 1000 before, during, or after wearing the device 1000 on the
foot.
[0131] Referring to FIG. 18F, the wearer may wrap the ankle strap
wings 1020, 1022 of the ankle strap 1010 of the wearable device
1000 around the wearer's ankle. The wearer may optionally use the
ankle strap fasteners 1024, 1026 to hold the two ends of the ankle
strap 1010 together. The wearer may consult with a medical
practitioner to set up the wearable device 1000 and the control
1500.
[0132] Once the wearable device 1000 and the control 1500 are
placed on the wearer's foot, the wearer may turn on the control
1500 by operating the power controller 1502. The control 1500 may
indicate via the display screen 1506, the power indicator 1508,
and/or the stimulation indicator 1510 if the control 1500 is not
connected to the wearable device 1000 when the control 1500 is
turned on. After turning on the power of the control 1500, the
wearer may increase the intensity of the electrical stimulation by
operating the stimulation adjuster 1504. The wearer may feel an
electrical sensation as the intensity of the electrical stimulation
increases. The wearer may experience a visible curl of the wearer's
toes as the intensity of the stimulation increases. The level of
stimulation may vary from individual to individual. The wearer may
decrease the intensity of the electrical stimulation by operating
the stimulation adjuster 1504. The wearer may decrease the
intensity of the stimulation through the stimulation adjuster 1504
when the wearer feels discomfort.
[0133] Before removing the control 1500 from the wearable device
1000, the wearer may reduce the intensity of the electrical
stimulation to zero by operating the stimulation adjuster 1504 or
turn the control 1500 off by operating the power controller 1502.
The control is safe to remove from the wearable device 1000 when
the intensity of the stimulation is zero or the control is turned
off. The control 1500 may further comprise a safety module that
locks the control 1500 to the wearable device 1000 when the control
1500 is turned on, and intensity of the electrical stimulation is
not zero.
[0134] In one aspect of the present invention, the wearable device
1000 and the control 1500 may be ideally operated at temperature
from 5.degree. C. to 38.degree. C., relative humidity from 15% to
93%, atmospheric pressure from 700 hPa to 1060 hPa, and altitude up
to 3000 m above sea level.
[0135] The present invention has been described in relation to
particular examples, which are intended to be illustrative rather
than restrictive, with the scope and spirit of the invention being
indicated by the following claims and their equivalents.
* * * * *