Note: Descriptions are shown in the official language in which they were submitted.
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ELECTRICAL ST~IULATION APPARATUS AND METHOD
Background of the Invention
[0001] This invention is directed towards an electric nerve or muscle
stimulator, and in particular a stimulator that is controlled based on
detected
breathing patterns.
[0002] Recent years have seen a rise in interest in western countries in
alternative therapies such as meditation, acupressure, and acupuncture,that
have been practised in eastern cultures for thousands of years. Interest in
more
contemporary variations of alternative therapies such as electrical muscle and
nerve stimulation has also soared in recent years, resulting in a
proliferation of
transcutaneous electric stimulation devices appearing on the market.
[0003] Numerous branches of medicine deal with the stimulation of the
body's nervous system. Traditional Chinese acupuncture is based on the
proposition that stimulation of specific areas on the skin affects the
functioning of
certain organs of the body and can balance energy levels in the body. It has
evolved into a system of medicine that is believed by many to restore and
maintain health by the insertion of fine needles into acupuncture points just
beneath the body surface that lie on channels of energy. Small electric
currents
may also be used in the place of fine needles. In Western medicine, sending an
electrical impulse to selected nerve fibres in the spinal cord (spinal cord
stimulation) is used to block pain messages from the spinal cord to the brain.
[0004] Breathing efficiently has been shown to improve and promote health
and personal well-being. Meditation and Tai Chi both use breathing methods
that
are intended to focus the mind and promote deep-relaxed breathing. It has been
observed that meditation leads to a °relaxation response " resulting in
changes in
the body that are deeply restorative and which quicken healing. These changes
include reductions in heart rate, blood pressure, respiratory rate, oxygen
consumption, blood filow to skeletal muscles, perspiration and muscle tension,
as
well as an improvement in immunity. Some eastern doctrines, for example
Taoism, rely on a combination of breath control and exercise to achieve a
healthy
mind and body by stimulating energy flow through the body. Some experienced
and highly trained practitioners of meditation use stimulation of muscles and
or
nerves below the base of the spine (for example, the rectal sphincter muscle)
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and along the back at appropriate times during the meditative breathing cycle
to
balance energy flow through the body resulting in further promotion of the
benefits of meditation. In the past, the stimulation has been done by the
person
meditating manually clenching or activating selected muscles at certain times
during his or her meditative breathing cycle. This requires the person
performing
the meditation to be highly trained and motivated in order to coordinate their
breathing and muscle activity to achieve maximum benefits.
(0005] It is therefore desirable to provide a method and device that
reinforces proper meditative breathing and that assists a person in
stimulating
selected muscles or nerves during his or her breathing cycle.
Summar~~of the Invention
[0006] The present invention provides an electrical stimulation device
including a breathing pattern detector and electrodes to stimulate selected
tissues of a user in coordination with the user's breathing pattern.
Electrical
stimulation is preferably performed at the anal area and along the spine of
the
user at selected times during each breathing cycle in order to assist in
promoting
relaxation and a feeling of well-being.
[0007] According to one aspect of the invention, there is provided an
electrical stimulation device for applying a stimulation signal to living
tissue. The
device inlcudes a sensor for sensing breathing of a person, at least a first
electrode pair and a second electrode pair for contacting the living tissue of
the
person, and a controller responsive to the sensor and operatively connected to
the first electrode pair and the second electrode pair. The controller is
configured
to determine a breathing cycle pattern of the person based on input from the
sensor and cause the first electrode pair and the second electrode pair to
apply a
stimulating first waveform signal and second waveform signal, respectively, to
the living tissue based on the determined breathing cycle pattern of the
person.
Preferably, the controller is configured to cause the first electrode pair and
the
second electrode pair to apply the first waveform signal and the second
waveform signal, respectively, to the living tissue for predetermined
durations
during each determined breathing cycle of the person during a treatment
period,
the second waveform signal commencing a predetermined delay after
commencement of the first waveform signal in each breathing cycle. As well,
the
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first electrode pair is preferably adapted to be applied to an anal area of
the
person, and the second electrode pair is adapted to be applied higher than the
first electrode pair to a lower spine area of the person.
[0008] According to a further aspect of the present invention, there is
provided a method for applying a stimulation signal to living tissue that
includes:
(a) monitoring the breathing pattern of a person; and (b) applying
stimulating electrical waveforms signals to the anal area of the person in
response to the monitored breathing pattern. According to yet a further aspect
of the invention, there is provided a method for applying a stimulation signal
to
living tissue that includes (a) monitoring the breathing pattern of a person;
and
(b) applying stimulating electrical waveforms signals to the spinal area of
the
person in response to the monitored breathing pattern.
[0009] According to still a further aspect of the invention there is provided
an electrical stimulation device for applying electrical stimulation to living
tissue,
including a plurality of electrode pairs adapted to be applied along a spinal
area
of a person, a sensing device for sensing breathing of the person, and a
controller connected to receive signals from the sensing device and control
operation of the electrode pairs, the controller being configured to, based on
signals received from the sensing device, cause the electrode pairs to apply
stimulating electrical pulses to areas of the person to which they are
respectively
applied.
[0010] ~ther aspects and features of the present invention will become
apparent to those ordinarily skilled in the art upon review of the following
description of specific embodiments of the invention in canjunction with the
accompanying figures.
Brief Description of the Drawings
[0011] Figure 1 is a partial front view showing a person wearing an
electrical stimulation device according to embodiments of the present
invention.
[0012] Figure 2 is a partial back view of a person wearing the electrical
stimulation device of Figure 1.
[0013] Figure 3 is a partial bottom view of the person wearing the electrical
stimulation device of Figure 1.
[0014] Figure 4 is a perspective view of a preferred embodiment of an
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electrical stimulation controller of the electrical stimulation device of the
present
invention;
(0015, Figure 5 is a schematic diagram of a preferred embodiment of the
electronic stimulation device of the present invention.
[0016) Figure 6 is a flowchart of the operation of the electric stimulation
device in accordance with embodiments of the present invention.
[0017] Figure 7 is an illustrative timing diagram showing operation of
sensor switches of the electrical stimulation device.
[0018) Figure 8 is a graph showing stimulation signals generated by the
electrical stimulation device during a first mode of operation in accordance
with
embodiments of the present invention.
[0019) Figure 9 is a graph showing stimulation signals generated by the
electrical stimulation device during a second mode of operation in accordance
with embodiments of the present invention.
[0020) Figure 10 is a graph showing stimulation signals generated by the
electrical stimulation device during a third mode of operation in accordance
with
embodiments of the present invention.
[0021] Figure 11 is a graph showing stimulating signals generated by the
electrical stimulation device during a fourth mode of operation in accordance
with
embodiments of the present invention.
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Disclosure of Examnie Embodiments
[0022] With reference to Figures 1-3 an electric stimulation device 10 in
accordance with preferred embodiments of the invention is shown mounted on a
person 12. The electric stimulation device 10 includes a sensor belt 14, an
electrode belt 16 and a control unit 18. The sensor belt 14 is provided and
formed of any suitable flexible and resilient material and can be adjusted to
fit
the user's torso size. As an illustrative example, the sensor belt 14 may
preferably be designed as an elastic or non-elastic belt and may be of any
desired adjustable length which will fit both men and woman (for example from
30 inches to 65 inches). Also, the sensor belt 14 may be of any suitable or
desired construction and material and may have any suitable closure or buckle
to
allow easy installation of the sensor belt about the person's torso. Attached
to
the sensor belt are two sensor units 20. Each of the senor units 20 include a
pressure sensitive switch that closes when a sufficient amount of pressure is
applied thereto. The pressure mounted switch can be mounted in a sensor
housing which can be secured by adhesive or velcro (TM) hook and loop like
material positioned on the sensor housing and the sensor belt 14, thereby
permitting the position of the sensor units 20 to be adjusted on the sensor
belt
14. In use, the two sensor units 20 are preferably positioned such that one of
the sensor units 20 is located toward one side of the abdomen and the other
sensor unit 20 is located towards another side of the abdomen ef the user 12.
The pressure sensitive switches of the sensor units 20 are directed inwards
towards the person 12 such that movement of the person's abdomen in an
outward direction will cause the pressure switches located within the sensor
units
20 to close, and subsequently open upon retraction of the abdomen of the
person
12. The sensor units 20 are electrically connected to the control unit 18 such
that the control unit 18 can detect whether one or both of the pressure
switches
associated with the sensor unit 20 are closed and/or open.
[0023] The electrode belt 16 preferably includes three pairs of treatment
electrodes including a first "anal zone" pair of electrodes 22A, 22B, a second
"lower back zone" pair of electrodes 24A and 24B and a third "upper back zone"
pair of electrodes 26A, 26B. The treatment electrodes are each preferably
formed from flexible material having a conductive grid embeded therein for
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transferring electrically energy from the electrodes to the human body. The
conductive surfaces of each of the electrodes may have a conductive gel pad
affixed thereto to assist securing the electrodes to the person I2 and also to
increase conductivity between the electrodes and the skin of the person 12.
r0024] As illustrated in Figures 1-3, in a preferred embodiment the three
electrode pairs are longitudinally positioned along the elongate electrode
belt 16
so that they can be positioned on the person 12 with the first pair of
electrodes
22A, 22B being located at the anal area of the person 12, the second pair of
electrodes 24A, 24B can be located along a longitudinal spinal area above the
first electrode pair 22A, 228, and the third electrode pair 26A, 26B can be
positioned along an upper spinal area above the second electrode pair 24A,
24B.
The electrode belt 16 includes straps 28 and 30 which extend from an upper
portion of the belt located near the top electrode 24B to a lower part of the
belt
located near the front of electrode 22A in order to assist in fastening the
electrode belt 16 to the body of the person 12. The straps 28 and 30 are
intended to extend from the belt to pass around opposite sides of the neck of
the
person 12, extend down the front of the body of the person, and connect in the
crotch area to a bottom portion of the electrode belt 16. The straps 28 and 30
are preferably adjustable in length and include a buckle or other realeasable
closure means to enable the electrode belt 16 to be removed from the body of
the person 12.
(0025] Although the electrodes 22A-26B are illustrated as being fastened
along a belt, the electrodes could alternatively each be physically separated
from
each other and individually placed on the body of the person 12 in the
locations
indicated in the figures. Positioning the electrodes along the electrode belt
16
offers an advantage however in that it assists in securing the electrodes to
the
body of the person 12, and furthermore assists in achieving the correct
electrode
ordering and positioning along the spine and lower spine areas of the person
12.
Each of the electrode pairs 22A-B, 24A-B and 26A-B are electrically connected
through a multiple conductor cable 32 to the control unit 18, In a preferred
embodiment, each of the electrode pairs is arranged so that adjacent pairs
have
alternating polarity in order to minimize electrical interference between the
electrodes. For example, electrodes 22B and 24A are both positive electrodes,
and electrodes 24B and 26A are both negative electrodes.
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[0026] Turning to Figure 4, the control unit 18 includes a circuit that is
housed within a housing 34. A female connector 60 is provided for receiving
male connector 62 from which a number of conductive wires extend to the
sensors 20 and electrodes 22A-268. The control unit i8 includes a master power
on/off switch 38 for turning the control unit 18 on and off, an upper back
switch
40 for adjusting the intensity of the signal provided to the upper back zone
electrode pair 26A, 26B; a lower back switch 42 for adjusting the electrode
intensity to the lower back zone electrode pair 24A-248; and an anal muscle
switch 44 for adjusting the signal provided to the anal zone electrode pair
22A-
228. A repeat switch 46 is provided to allow restarting of another timed cycle
using the settings recorded for the previous timed cycle.
[0027 In one preferred embodiment, a lung breathing mode switch 48,
jogging and walking mode switch 50, abdominal breathing mode switch 52,
exercise mode switch 58 and mediation mode switch 59 are provided for
selecting between five different modes of operation for the electric
stimulation
device 10, as wilt be explained in greater detail below. A time selector
switch 54
is provided to allow a user to select between one of three different possible
treatment time durations, the selected length of which is indicated by visual
indicator. In the embodiment shown in Figure 4, a first display element LED 1
lights up if the selected time is 15 minutes, a second display element LED2
lights
up if the selected time is 20 minutes, and a third display element LED3 lights
if
the selected treatment time is 25 minutes. Display elements LED4, ZEDS, LED6,
LED12 and LED13 are located next to the lung breathing mode switch 48, jogging
and walking mode switch 50, abdominal breathing mode switch 52, exercise
mode switch 57, and mediation mode switch 59, respectively, to provide a
visual
indication of which of these five possible modes has been selected by the
user.
Three display elements LED7A-LED7C are located next to the upper back switch
40 to provide a visual indication of which of three possible intensity levels
have
been selected by the user in respect of the upper back zone electrode pair 26A-
268. Similarly, three display elements LEDBA-LEDBC are positioned next to
lower back switch 42 and four display elements LED9A-LED9D are positioned
next to anal muscle switch 44 to indicate the different intensity levels that
have
been selected by such switches for the electrode pairs 24A-B and 22A-B,
respectively. A thumbwheel 58 is provided as a master intensity selector to
allow
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the user to adjust the maximum desired strength of signal supplied to all
three
pairs of electrodes. The wheel 58 may have the indicia 1-5 printed on an outer
surface thereof and visible through a window 36 in the housing to provide an
indication to the user of the maximum intensity level that has been selected.
A
range selection switch 56 is provided for use in conjunction with intensity
selection switches 40, 42 and 44, and thumbwheel for adjusting the signal
intensity applied to the electrode pairs. Two display elements LED10A and
LED10B are provided to indicate which of two possible intensity ranges are
selected, with LED10A indicating a "low" range and LED10B indicating a "high"
range.
[0028] Referring now to Figure 5, there is shown a partially block, partially
schematic diagram of the electric stimulation device 10 according to preferred
embodiments of the instant invention. The data processing functions of the
instant invention are performed by a microcomputer or CPU 66 which is,
preferably, a single integrated circuit data processing chip. In a preferred
embodiment, the CPU 66 includes memory 68. The memory 68 can take the
form of an electrically erasable, programable, read-only memory (EE prom).
While not limited thereto, the CPU 66 is preferably a stand alone, high
performance single chip micro-controller fabricated in plus 5 volt advanced
CMOS
technology so as to provide low power consumption along with high speed
operation. The memory 68 is used by the CPU 66 for a storage of the
application
specific instructions required for the functionality of the present invention
as
described herein.
[0029] The electric stimulation device 10 is powered by a rechargeable 9
volt nickel-cadmium battery 70. An external DC voltage obtained from an
external AC/DC converter (120 VAC to 9VDC) can be applied to a jack 72 to
recharge the battery 70, or alternatively act as the power supply for the
electric
stimulation device 10. A diode 74 placed in parallel with the battery 70
protects
against damage to the battery resulting from incorrect polarity of power
applied
to jack 72. Master Power on/off switch 38 is connected in series with the
batter
70. A DC to DC converter 76 is used to convert the 9 volt power supply to a
usable 5 volt DC logic voltage VCC. The 5 volt VCC is supplied to the CPU 66,
digital potentiometers 78, 80 and 82 and the 19 status display elements LED1-
LED12. (For the purpose of simplifying the diagram on Figure 5, only one
display
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element LED1 is shown. However, the 19 additional LEDs are each individually
connected to the CPU 66 in a manner similar to display element LED1.)
[0030] The 9 volt source is connected through a manually actuated
potentiometer 84 to supply power to the resistor portions of each of the
digital
potentiometers 78, 80 and 82. The value of the manual potentiometer 84 is
controlled by thumbwheef 58 and determines the maximum intensity of the
signal that can be provided to the respective signal input terminals 87, 89
and 91
of each of the digital potentiometers 78, 80 and 82. A sensor input 85 from
the
potentiometer 84 is provided to the CPU 66 so that the CPU 66 can track the
potentiometer setting (and hence the position of thumbwheel 58). The switches
40 to 57 and 59 are all electrically connected to the CPU 66 such that the CPU
66
can determine when such switches have been depressed. Similarly, pressure
switches 64A and 64B, each of which is located within a respective sensor unit
20, are electrically connected to the CPU 66 such that the CPU 66 can
determine
when one, or the other, or both of the sensor pressures switches 64A or 64B
are
closed or open. The CPU 66 is operatively connected to each of the digital
potentiometers 78, 80 and 82 so that the CPU 66 controls the tap location in
each of the respective potentiometers 78, 80 and 82. Thus, while manual
potentiometer 84 (which is adjusted by the thumbwheel 58) dictates the
maximum voltage of the signal that can be applied to input terminals 87, 84
and
91 of the digital potentiometers 78, 80 and 82, the CPU 66 controls what
proportion of the maximum voltage is actually output on the output terminals
86,
88 and 90 of the potentiometers.
[0031] The output terminal 90 of the digital potentiometer 82 is connected
to supply power to the anal zone electrode pair 22A-22B via a transistor Q1
and
an isolation transformer T1. The output terminal 88 of digital potentiometer
80 is
connected to supply power to the lower back zone transistor pair 24A-24B via
transistor Q2 and isolation transformer T2, and similarly the output terminal
86
of digital potentiometer 78 is connected to supply power to the upper back
electrode pair 26A-26B via a transistor Q3 and isolation transformer T3. The
base
of each of the transistors Q1, Q2 and Q3 is connected to the CPU 66 such that
the CPU 66 can turn each of the transistors Q1, Q2 and Q3 selectively on and
off
in accordance with predetermined patterns to permit signal pulses to be output
from the respective electrode pairs. Accordingly, the frequency and duration
of
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the signals output by the respective electrode pairs is controlled by the CPU
66
gating of transistors Q1, Q2 and Q3. The amplitude of the signals output by
the
electrode pairs is controlled by adjustment of the digitaP potentiometers 78,
80
and 82 by the CPU 66, with the maximum amplitude of the output signals being
determined by the position of manually adjusted tap 84.
[0032] The isolation transformers T1, T2 and T3 are sized to convert the
voltages provided by transistors Q1, Q2 and Q3 to a final desired output
level.
For example, in one embodiment, the transformers T2 and T3 are sized to
provide a maximum output voltage of 35-40 volts volts, and the isolation
transformer T1 has a turns ratio to provide 50% of that value.
[0033] A piezoelectric crystal 92, together with capacitors 94A and 94B
provides a stable frequency source for the operation of the time and control
functions of the CPU 66.
[0034] An overview of the various components of the stimulation device 10
having been provided, its operation will now be explained in greater detail.
During operation, the control unit 18 is configured to apply stimulating
pulses to
each of the electrode pairs 22A-228, 24A-24B and 26A-26B for predetermined
intervals during each breathing cycle of the person using the device. The
timing
of the predetermined intervals within each breathing cycle and the length of
the
predetermined intervals depends on which one of the five possible modes have
been selected by the user through activation of the lung breathing mode switch
48, the jogging and walking mode switch 50, the abdominal breathing mode
switch 52, the exercise mode switch 57 or the mediation mode switch 59. The
treatment time that the device operates continuously for is selected by the
user
using time selector switch 54, which in the illustrated embodiment allows for
three different run times, namely 15, 20, and 25 minutes. The selected
treatment time is identified by a corresponding visual indicator LED1, LED2
and
LED3. A maximum pulse intensity for the three electrode pairs is determined by
the setting of the thumbwheel 58 and the range that has been selected by the
range selector switch 56. In particular, the CPU 66 is configured to allow the
digital potentiometers 78, 80 and 82 to output signals within two possible
ranges,
namely a "high" range and a "low" range, as selected by the range selector
switch 56. The default is "low" range, and when such range is selected, the
CPU
66 will only allow the digital potentiometers 78, 80 and 82 to output up to a
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maximum of 50% of the signal intensity applied to their respective input
terminals 87, 89 and 91. If the CPU 66 detects that the range selection button
56 is pressed twice in quick succession at the same time that the thumbwheel
58
is positioned at its lowest intensity setting "1", it will place the control
unit 18 into
a "high" range in which the CPU 66 will allow the digital potentiometers to
output
between 50 to 100% of the signal intensity applied to their respective input
terminals 87, 89 and 91. In one embodiment, the control unit 18 will, once
"high" range has been selected, continue to operate in high "range" until the
user
moves the thumbwheel out of then back into its lowest intensity "1" setting,
or
the control unit is turned off. Thus, the setting of thumbwheel 58, and the
range
selected by range selector 56 determines the maximum pulse intensity that can
be applied to each of the electrode pairs. Within either the "high" or "low"
ranges,
a percentage of the maximum pulse intensity applied to the electrode pairs is
individually determined for each pair by the corresponding upper back switch
40
(for the upper back zone electrode pair 26A-26B), lower back switch 42 (for
the
lower back zone electrode pair 24A-24B), and anal muscle switch 44 (for the
anal
zone electrode pair 22A- 22B). In particular, the switches 40 and 42 each
allow
for three different intensity levels to be selected, namely 70%, 85% and 100%
of
the maximum pulse intensity as determined by the thumbwheel 58 and range
selector switch 56. Visual indicators t_ED7 and t-ED8 indicate what intensity
level
has been selected by switches 40 and 42 respectively. As the anal area tends
to
have a greater degree of sensitivity, the anal muscle switch 44 allows for
four
different intensity levels to be selected, namely 70%, 80%, 90% or 100% of the
possible maximum intensity value. As noted above, the isolation transformer
associated with the anal zone electrode pair 22A-22B is, in one embodiment,
sized such that the maximum pulse intensity for the anal zone electrode pair
is
half that of the lower and upper back zone electrode pairs 24A-24B and 26A-
26B.
[0035] The inclusion of the range selection switch is of course an optional
embodiment of the invention, however its presence ensures that the user of the
device 10 has actively decided to use the higher intensity voltages, rather
than
mistakenly selected a higher intensity.
[0036] In one embodiment of the invention, the control unit 18 is
coni'fgured so that the electrical pulses provided to the lower and upper back
zone electrode pairs 24A-24B and 26A-26B can have a maximum voltage
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amplitude of up to 10V in '~low" range, and a maximum current of llmA, and a
maximum voltage of 20v in "high" range and a maximum current of l8mA. The
electrical pulses provided to the anal zone electrode pair have half the
voltage
values note above. The voltages and currents provided above are merely
illustrative.
[0037] The power on/off switch 38 is used to activate the stimulation device
10. The flowchart 100 of Figure 6 is illustrative of the operation of one
embodiment of the stimulation device 10 once it has been turned on. When first
turned on, the CPU 66 performs an initialization routine ( step 100-1) during
which it is reset and configured to select as default values the lowest
intensity
values for the anal muscle zone, tower back zone and upper back zone electrode
pairs, and the lowest operating time duration (15 minutes in the illustrated
embodiment). The stimulation device 10 will not commence pulsing operation
until the user selects an operating mode by pressing one of the mode selection
switches 48, 50 or 52 at the same time that the thumbwheel 58 is set to its
lowest intensity "1" (step 100-2). The first time a user selects an operating
mode
after the device 10 has been turned on, the control unit 18 will execute a
"learn
breathing" routine (step 100-3) during which the CPU 66 monitors input from
the
pressure switches 64A and 64B to determine a breathing pattern for the user
(person 12). In particular, the CPU 66 monitors the operation of the pressure
switches 64A and 64B over a number of breathing cycles of the person to
determine an approximate breathing pattern of the person. In tine preferred
embodiment of the invention, the device 10 is used in conjunction with a
controlled breathing pattern , with the person 12 receiving pre-use
instructions,
perhaps in the form of printed or video materials provided with the device 10,
on
the desired breathing techniques for each of the different modes of operation
of
the stimulation device 10.
[0038] For the purpose of better explaining the operation of the present
invention, Figure 7 is an illustrative timing diagram showing possible
operation of
the switches 64A and 64B during the breathing cycle of the person 12. A single
breathing cycle commences when the person 12 starts inhaling, and concludes
when the person 12 stops exhaling. In Figure 7, the operation of switches 64A
and 64B over two complete breathing cycles is represented, with each breathing
cycle having a duration of T seconds, with inhalation lasting J seconds, and
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exhalation lasting T-) seconds. At some point during inhalation, the pressure
switches 64A and 64B will close as a result of the pressure applied to them
due to
the expansion of the torso of the person 12, and at some time during
exhalation,
the pressure switches 64A and 64 B will subsequently open back up due to
contraction of the torso of the person 12. The time that the switches 64A and
64B are closed, or "on" during the two breathing cycles (illustrated in Figure
7 by
the lines 96 and 98 respectively), and the time that they are open is
monitored
by the CPU 66 over a number of breathing cycles during the learn breathing
routine. In one embodiment, the CPU 66 is configured to perform the learn
breathing routine (step 100-3 of Figure 6) for a predetermined time period
such
as two minutes. Alternatively, the CPU 66 could be configured to perform the
learn breathing routine until it detects that the person 12 has, within
predetermined variance thresholds, maintaining an consistent breathing rate
over
a predetermined number of breathing cycles (for example, five breathing
cycles).
At the conclusion of the learn breathing routine, the CPU uses the information
obtained from the two sensor switches 64A and 64B to determine, with
reasonable accuracy, the average breathing cycle timing of the person 12,
including breathing cycle duration, inhalation start and end timing, and
exhalation start and stop timing. Although Figure 6 illustrates the pressure
switch
64A as closing prior to the pressure switch 648 during each breathing cycle,
it
will be appreciated that the relative timing of the switches will depend on
their
location on the person 12.
[0039] In some embodiments of the invention, activation of both switches
64A and 64B is required for the CPU 66 to conclude that a breathing cycle is
in
process. In another embodiment, the CPU 66 is configured to detect a breathing
cycle upon the activation of either one of the switches 64A and 64B, thus
allowing detection of breathing cycle even if one of the sensors is not
activated
during a particular breathing cycle due to the position of the user's body.
[0040, Once the initial learn breathing routine has been successfully
completed, the control unit 18 will commence sending poises to the three
electrode pairs in accordance with the selected mode of operation for the
duration of the run time as selected by the user through time selector 54
(step
100-4). In addition to determining the person's 12 breathing pattern during
the
initial learn breathing routine, the CPU 66 continuously tracks the person's
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breathing (step 100-5) throughout the ongoing operation of the device 10 in
order to detect and compensate for on-going variations in the person's
breathing
pattern during use. In one embodiment, the CPU 66 is configured to calculate
new average breathing cycle timing values at predetermined intervals based on
values taken during a predetermined preceding time interval. For example, the
CPU 66 could be con>'Igured to calculate new average values every minute based
on average readings taken over the pervious two minutes. Preferably, the CPU
66 is configured to detect and ignore false triggering of the switches 64A and
64B
that may occur, for example, from a sudden movement of the person 12. In this
regard, the CPU may be configured to ignore, after the initial learn breathing
routine, sporadic triggering of the switches 64A and/or 64B that occurs
outside of
a predetermined time window for expected switch activity. Alternatively or
additionally, the CPU 66 could be configured to ignore new calculated average
timing values that vary more than a predetermined amount from the previous
calculated average timing values, and continue using the old values.
[0041] Figure 8 is illustrative of the voltage waveforms applied to the three
electrode pairs 22A-22B, 24A-24B and 26A-26B during step 100-4 in the event
that "lung breathing mode" has been selected by the user. In lung breathing
mode, the control unit 18 is configured to apply a low frequency voltage pulse
waveform to each of the electrode pairs for predetermined durations during the
inhalation portion of the breathing cycle (in Figure 8, inhalation occurs
during the
duration 0 to J for one breathing cycle, and duration T to T+J for the
subsequent
breathing cycle). In particular, the CPU 66 is configured to, at the
calculated
inhalation start time of the person 12, start pulsing the gate of the
transistor Q1
that is associated with the anal zone electrode pair 22A -22B to cause
stimulating
electrical pulses to be applied through the anal zone electrode pair 22A-22B
to
the anal zone area of the person 12, as indicated by illustrative waveform
110.
The CPU 66 is configured to continue sending the pulses to the electrode pair
22A-22B throughout inhalation and then cease at the start of the exhalation
portion of the breathing cycle.
[0042] As indicated in Figure 8, the CPU 66 is configured to start pulsing, at
a predetermined delay (x) after commencing pulsing of the anal zone electrode
pair 22A-22B, the gate of the transistor Q2 that is associated with the lower
back
electrode pair 24A-24B to cause stimulating electrical pulses to be applied
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CA 02484880 2004-10-15
through the lower back zone electrode pair 24A-24B to the lower back/spine
area of the person 12, as illustrated by the waveform 112. The CPU 66 is
configured to continue sending the pulses to the electrode pair 24A-24B
throughout the rest of the inhalation portion and then cease at the start of
the
exhalation portion of the breathing cycle. The CPU 66 is also configured to
start
pulsing, at a predetermined delay (x) after commencing pulsing of the lower
back
zone electrode pair 24A-24B, the gate of the transistor Q3 that is associated
with
the upper back electrode pair 26A-26B to cause stimulating electrical pulses
to be
applied through the upper back electrode pair 26A-26B to the upper back/spine
area of the person 12, as illustrated by the waveform 114. The CPU 66 is
configured to continue sending the pulses to the electrode pair 26A-26B
throughout the rest of the inhalation portion and then cease at the start of
the
exhalation portion of the breathing cycle.
[0043] Thus, in lung breathing mode, during each breathing cycle, the anal
zone electrode pair 22A-22B is activated commencing at the start of
inhalation,
followed after a predetermined delay by the lower back electrode pair 24A-248,
followed after a further predetermined delay by the upper back electrode pair
26A-26B, with stimulating pulses from all three electrode pairs continuing
through the remainder of inhalation and ceasing at the start of exhalation,
with
the inhalation and exhalation start times being determined by the CPU 66 based
on the operation of pressure switches 64A and 64B during the learn breathing
routine and previous breathing cycles. The delay between the activation of the
electrode pairs simulates manual activation of different muscles during the
breathing cycle. In one preferred embodiment, the predetermined delay (x) is
100ms, with pulsing of the lower back electrode pair 24A-24B occurring 100ms
after the start of anal zone electrode pair 22A-22B, and pulsing of the upper
back
electrode pair 26A-26B occurring 100ms after the start of the lower back
electrode pair. However, the delay (x) could have other values for example,
50ms to 150ms, and could be variable either through manual input, or
calculated
by the CPU 66 as a percentage of the measured breathing cycle. Breathing cycle
mode assists in training the user to take long and deep breaths as stimulation
occurs only during inhalation, thus providing feedback to the user while they
are
inhaling.
[0044] As indicated above, the amplitude of the applied voltage pulses to
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CA 02484880 2004-10-15
the electrode pairs 22A-228, 24A-24B and 26A-26B is variable based on what
fraction of a maximum possible voltage amplitude (as determined by thumbwheel
58 and range selector switch 56) has been selected by the user of the device
10
via the respective intensity selector switches 40, 42 and 43. During step 100-
4,
the CPU 66 monitors these switches, and will adjusts the digital
potentiometers
78, 80 and 82 accordingly. In one preferred embodiment, as illustrated in
Figure
8, the CPU 66 is configured to cause the pulses occurring at the start of the
waveforms 110, 112 and 114 to ramp up in value, maintain a selected amplitude,
and then ramp down in value at the end of the waveforms 110, 112 and 114
(through adjustment of the digital potentiometers 78, 80 and 82). Such ramping
up and down softens the changes in tissue stimulation that occurs during use
of
the device but is not necessary for all embodiments of the invention.
[0045] When they are applying voltage, the electrodes are preferably
providing pulses with a frequency of up to 100Hz when "Low" intensity has been
selected and up to 250Hz when "high" intensity has been selected, although
other values are possible. in one embodiment, the CPU 66 is configured to vary
the frequency of the pulses of waveforms 110,112 and 114 while the waveforms
are being generated, thus exposing the body tissues to variations in pulse
frequency.
[0046 The CPU 66 is configured to continue running the selected mode for
a treatment period corresponding to the amount of time selected by time
selector
switch 54. If the repeat button 46 is pressed (step100-6), the CPU 66 will re-
commence the latest program mode it just ran using the latest settings for
treatment time and intensity.
[0047 In jogging and walking mode and abdominal breathing mode, the
stimulation device 10 functions in a similar manner as in lung breathing mode,
except for the differences noted below. Figure 9 is illustrative of the
voltage
waveforms applied to the three electrode pairs 22A-22B, 24A-24B and 26A-26B
during step 100-4 in the event that '°exercise mode" has been selected
by the
user. In jogging and walking mode, the control unit 18 is configured to apply
a
low frequency voltage pulse waveform to each of the electrode pairs for
predetermined durations commencing at predetermined times after the start of
the inhalation portion of the breathing cycle, and ending at a predetermined
time
prior to the end of the exhalation portion. In particular, the CPU 66 is
configured
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CA 02484880 2004-10-15
to, after an interval of K seconds after the calculated inhalation start time
of the
person 12, start pulsing the gate of the transistor Q1 that is associated with
the
anal zone electrode pair 22A -22B to cause stimulating electrical pulses to be
applied through the anal zone electrode pair 22A-22B to the anal zone area of
the person 12, as indicated by illustrative waveform 116. The CPU 66 is
configured to continue sending the pulses to the electrode pair 22A-22B until
a
predetermined time prior to the end of the exhalation portion, namely L
seconds
after the calculated inhalation start time. In one preferred embodiment, the
active pulsing duration of the waveform 116, namely L minus K, is selected by
the CPU 66 to be equal to 75% of the duration T of the breathing cycle, with K
being 1/8th of T and T minus L being 1/8th of T.
[0048] As indicated in Figure 9, in jogging and walking mode the CPU 66 is
configured to start pulsing; at a predetermined delay (y) after commencing
pulsing of the anal zone electrode pair 22A-22B, the gate of the transistor Q2
that is associated with the lower back electrode pair 24A-24B to cause
stimulating electrical pulses to be applied through the lower back zone
electrode
pair 24A-24B to the lower back/spine area of the person 12, as illustrated by
the
waveform 118. The CPU 66 is configured to continue sending the pulses to the
electrode pair 24A-24B until a predetermined time prior to the end of the
exhalation portion, namely L seconds after the calculated inhalation start
time.
The CPU 66 is also configured to start pulsing, at a predetermined delay (y)
after
commencing pulsing of the lower back zone electrode pair 24A-248, the gate of
the transistor Q3 that is associated with the upper back electrode pair 26A-
26B
to cause stimulating electrical pulses to be applied through the upper back
electrode pair 26A-26B to the upper back/spine area of the person 12, as
illustrated by the waveform 120. The CPU 66 is configured to continue sending
the pulses to the electrode pair 26A-26B until a predetermined time prior to
the
end of the exhalation portion, namely L seconds after the calculated
inhalation
start time.
[0049] Thus, in jogging and walking mode, during each breathing cycle, the
anal zone electrode pair 22A-22B is activated after a predetermined delay from
the start of inhalation, followed after a further predetermined delay by the
lower
back electrode pair 24A-248, followed after yet a further predetermined delay
by
the upper back electrode pair 26A-268, with stimulating pulses from all three
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CA 02484880 2004-10-15
electrode pairs continuing through the remainder of inhalation and ceasing
prior
to the end of exhalation, with the inhalation and exhalation start times being
determined by the CPU 66 based on the operation of pressure switches 64A and
64B during the learn breathing routine and previous breathing cycles. In one
preferred embodiment, the predetermined delay (y) is 200ms, with pulsing of
the
lower back electrode pair 24A-24B occurring 200ms after the start of anal zone
electrode pair 22A-22B, and pulsing of the upper back electrode pair 26A-26B
occurring 200ms after the start of the lower back electrode pair 24A-24B.
However, the delay (y) could have other values, and could be variable either
through manual input, or calculated by the CPU 66 as a percentage of the
measured breathing cycle.
[0050] Figure 10 is illustrative of the voltage waveforms applied to the
three electrode pairs 22A-228, 24A-24B and 26A-26B during step 100-4 in the
event that "abdominal breathing mode" has been selected by the user. In
abdominal breathing mode, the control unit 18 is configured to apply a low
frequency voltage pulse waveform to each of the electrode pairs for
predetermined durations during the exhalation portion of the breathing cycle.
In
particular, the CPU 66 is configured to, at the calculated exhalation start
time of
the person 12, start pulsing the gate of the transistor Q1 that is associated
with
the anal zone electrode pair 22A -22B to cause stimulating electrical pulses
to be
applied through the anal zone electrode pair 22A-22B to the anal zone area of
the person 12, as indicated by illustrative waveform 122. The CPU 66 is
configured to continue sending the pulses to the electrode pair 22A-22B
throughout exhalation and then cease at the end of the exhalation portion of
the
breathing cycle.
[0053] As indicated in Figure 10, in abdominal breathing mode the CPU 66
is configured to start pulsing, at a predetermined delay (x) after commencing
pulsing of the anal zone electrode pair 22A-22B, the gate of the transistor Q2
that is associated with the lower back electrode pair 24A-24B to cause
stimulating electrical pulses to be applied through the lower back zone
electrode
pair 24A-24B to the lower back/spine area of the person 12, as illustrated by
the
waveform 124. The CPU 66 is configured to continue sending the pulses to the
electrode pair 24A-24B throughout the rest of the exhalation portion and then
cease at the end of the exhalation portion of the breathing cycle. The CPU 66
is
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also configured to start pulsing, at a predetermined delay (x) after
commencing
pulsing of the lower back zone electrode pair 24A-24B, the gate of the
transistor
Q3 that is associated with the upper back electrode pair 26A-26B to cause
stimulating electrical pulses to be applied through the upper back electrode
pair
26A-26B to the upper back/spine area of the person 12, as illustrated by the
waveform 126. The CPU 66 is configured to continue sending the pulses to the
electrode pair 26A-26B throughout the rest of the exhalation portion and then
cease at the end of the exhalation portion of the breathing cycle.
[0052) Thus, in abdominal breathing mode, during each breathing cycle,
the anal zone electrode pair 22A-22B is activated commencing at the start of
exhalation, followed after a predetermined delay by the lower back electrode
pair
24A-24B, followed after a further predetermined delay by the upper back
electrode pair 26A-268, with stimulating pulses from all three electrode pairs
continuing through the remainder of exhalation and ceasing at the end of
exhalation, with the exhalation start and end times being determined by the
CPU
66 based on the operation of pressure switches 64A and 64B during the learn
breathing routine and previous breathing cycles. In one preferred embodiment,
the predetermined delay {x) is 100ms, with pulsing of the lower back electrode
pair 24A-24B occurring 100ms after the start of anal zone electrode pair 22A-
228, and pulsing of the upper back electrode pair 26A-26B occurring 100ms
after
the start of the lower back electrode pair. However, the delay (x) could have
other values, and could be variable either through manual input, or calculated
by
the CPU 66 as a percentage of the measured breathing cycle.
[0053) Electrical stimulation of the nerves in the anal area, followed by
subsequent stimulation of nerves along the spine in the lower back area,
followed
by subsequent stimulation of nerves along the spine in the upper back area,
done
in a consistent manner during breathing cycles over a duration of time can
promote relaxation and well being in the user of the electrical device 10. Use
of
the present device can train the user to practice deep breathing by
encouraging
the user to concentrate on long inhalations and exhalations by providing
electrical
feedback at different times during the breathing cycle depending on the mode
selected. Lung breathing mode is intended to be used to train the user to
expand their lung capacity, which in turn benefits the body due to increased
volumes of oxygen being introduced in the blood stream. Some doctrines,
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CA 02484880 2004-10-15
including Taoism and Yoga, advocate deep breathing meditation as a method for
purifying the body from toxins. Use of the device in walking and jogging mode,
and in particular tensing of the anal area caused by the electrical
stimulation, is
intended to prevent the escape of energy from the body to help re-energize
body
strength and improve health. Abdominal mode is intended to assist the user in
achieving what is known in Tao meditation as "bone marrow wash", which is
believed to stimulate the spinal chord and improve the immune system.
Abdominal mode also is intended to train the user to activate what is known as
Chakras (energy centres) in Yoga, in order to keep the flow of information
between the brain and other parts of the body flowing freely.
[0~54~ Figure 11 is illustrative of the voltage wave forms applied to the
three electrode pairs 22A-228, 24A-24B and 26A-26B in the event that "exercise
mode" has been selected by the user. In exercise mode, the CPU 66 is
configured to apply pulses of randomly varying frequency (50-180Hz on one
embodiment) and randomly varying amplitude to three electrode pairs
continuously throughout the treatment time. In one embodiment, the pulsing of
the electrode pairs is periodically ceased and then restarted during treatment
time in order to provide a reminder to the user to focus on proper breathing
and
meditation techniques during the treatment time. For example, the pulsing may
continue for 2 minutes, then cease for 30 seconds, then restart for 2 minutes,
and so on, throughout the treatment time, In exercise mode, the breathing
pattern of the user need not be measured, as the pulses are applied
irrespective
of the breathing cycles. As indicated in Figure 11, there may be predetermined
delays between activation of the anal zone electrodes, lower back zone
electrodes, and upper back zone electrodes at the start-up of the treatment
time.
Exercise mode is intended to generally confine energy in the body to help
promote the user's health.
j0055~ The fifth possible mode of operation of the present invention is
°Meditation Mode°', which is selected through the Meditation
Mode switch 59. In
meditation mode, the control unit progresses successively through lung
breathing
mode; abdominal breathing mode and exercise breathing mode for the duration
of the treatment time. For example, if the treatment time of 15 minutes is
selected, the control unit 18 will perform approximately three and a half
minutes
of each lunch and abdominal breathing mode, then 9 minutes of exercise mode.
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CA 02484880 2004-10-15
If the treatment time is 20 minutes, then the unit will perform about four
minutes each of Lung and Abdominal Mode, followed by 12 minutes of exercise
mode. If the treatment time is Z5 minutes, then the unit will perForm about 5
minutes each of lung and Abdominal mode, followed by 15 minutes of exercise
mode. Meditation mode is intended for use by persons who have mastered the
lung, abdominal and exercise modes independently, in order to provide the
benefits of these three modes.
[0056] In addition to encouraging the user to learn proper meditative
breathing, the stimulation provided under the different operational modes of
the
present invention are intended to stimulate the anal and spinal areas in a
manner
consistent with some eastern meditative doctrines (such stimulation
traditionally
being done by precisely timed self activation of muscles by a highly trained
meditation practitioner), thus permitting less skilled meditative
practitioners to
experience the same benefits previously available only to highly experienced
and
skilled practitioners.
[0057] It will be appreciated that the electrical stimulation device 10
described above could be modified in many respects and still perform the same
functions. For example, other pressure sensitive devices, such as strain
gauges,
could be used instead in sensor units 20 in place of switches 64A and 64B, and
the number of sensor units varied. Characteristics other than expansion of the
body torso could be used to determine breathing patterns - for example, a
microphone or airflow sensor could be used to detect breath entering and
exiting
the mouth of person 12. In some applications, the number of and/or location of
electrode pairs could be varied as well. Although the control unit 18 has been
shown as a central control unit implemented using a programmed CPU, it could
be implemented using other electronic configurations such as programmable
logic
circuits or dedicated electronic components such as ASICs, or combinations
thereof. Rather than be localized in a single housing, elements of the control
unit
18 could be distributed with greater functionality occurring at the sensor
units
20, for example.
[0058] While particular embodiments of the invention have been shown and
described, it will be obvious to those skilled in the art that various changes
and
modifications may be made without departing from the present invention in its
broader aspects.
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