Note: Descriptions are shown in the official language in which they were submitted.
CA 02707351 2010-06-10
=
IMPROVED CRANIAL-ELECTRO STIMULATOR
10
Field of the Invention
The present invention relates generally to a method and system of
electro-biological stimulation and more particularly to method and system,
which
supports current therapeutic techniques of electro-stimulation.
Background of the Invention
Nontraditional procedures that are used to manage pain include the
electrical stimulation of tissue. One method of accomplishing this is by
attaching
electrodes to a person's skin. This procedure, which is generally referred to
as
trans-cutaneous electro-stimulation (TENS), typically uses a square wave
signal
with a current that is in the microampere to milliampere range and a frequency
that normally varies from under a hertz to about 100 Hertz, which is applied
to a
1
CA 02707351 2016-04-14
select region of a person's anatomy such as, for example, the ear lobes or
across a
muscle.
SUMMARY OF THE INVENTION
There is disclosed a method and system for treating pain with cranial-electro
stimulation (CES) and trans-cutaneous electro-stimulation (TENS) where the
pulses
of the square wave signal are modified to provide a square wave stimulus edge
that
is somewhat rounded which provides a more tolerable procedure by reducing the
stinging sensation felt from the stimulus.
Certain exemplary embodiments can provide a device for reducing pain in a
person comprising: a first electrode configured for removably attaching to an
ear on
the person's head; a second electrode configured for removably attaching to
another ear on the person's head; and a computer or a digital port for
supplying to
the first and second electrodes rectangular voltage pulses of "1s" and "Os",
wherein
the "1s" have a potential that is a supply voltage of the computer or the
digital port
and the "Os" have a potential of no volts, and wherein at least a leading edge
of
each rectangular voltage pulse is rounded, wherein a frequency of the
rectangular
voltage pulses to either the first electrode or to the second electrode ramps
up or
down at a rate when the frequency of the rectangular voltage pulses to either
the
first electrode or second electrode changes.
In an embodiment of the invention the square wave stimuli pulses applied to
left and right parts of a person's body are randomized at 100 Hz to reduce
habituation.
2
CA 02707351 2016-04-14
In an embodiment of the invention randomized left and right electrical stimuli
pulse sare independently varied between 0.5 to 3 Hz to reduce habituation of
the
CES stimuli used for reducing the neurological perception of pain.
In an embodiment of the invention randomized left and right electrical
stimuli pulses are independently varied in the 0.5 ¨ 3 Hz range for treating
pain
directly over the affected area.
In an embodiment of the invention the method and system of cranial-
electro stimulation (CES) is combined with trans-cutaneous electro-stimulation
.. (TENS) for treating muscle pain.
The foregoing has outlined, rather broadly, the preferred feature of the
present invention so that those skilled in the art may better understand the
2a
CA 02707351 2010-06-10
detailed description of the invention that follows. Additional features of the
invention will be described hereinafter that form the subject of the claims of
the
invention. Those skilled in the art should appreciate that they can readily
use the
disclosed conception and specific embodiment as a basis for designing or
modifying other structures for carrying out the same purposes of the present
invention and that such other structures do not depart from the spirit and
scope
of the invention in its broadest form.
BRIEF DESCRIPTION OF THE DRAWINGS
Other aspects, features, and advantages of the present invention will
become more fully apparent from the following detailed description, the
appended claim, and the accompanying drawings.
FIG. 1 is a schematic diagram of a circuit that can be used to round the
corner of a square wave pulse by implementing a low-pass filter;
FIG. 2 is a schematic diagram of a circuit that can be used to round the
corner of a square wave pulse by implementing a pulse width control signal;
FIG. 3 shows examples of offsetting pulses that are applied to the left and
right ear lobes of a person; and
FIG. 4 shows the frequency of the signals to the left and right ears
changing at 0.1 Hz/second increments until a target frequency is reached
through multiple targets over time.
3
CA 02707351 2010-06-10
=
DETAILED DESCRIPTION OF THE INVENTION
This invention relates to using Cranial-electro Stimulation (CES) to
improve sleep and relieve pain. CES is an electrical stimulation technique
that
has been used for decades. It is officially recognized for the treatment of
anxiety,
depression and pain. CES is a form of Trans-cutaneous Electro-Stimulation
(TENS) in that an electrical stimulus is delivered through a person's skin
such as
his/her ear lobes. Because the stimuli are delivered specifically via the
person's
ear lobes and across his/her cranium, the Food & Drug Administration (FDA) has
classified this particular type of stimulation as CES.
It is generally believed that Cranial-electro Stimulation, when operating at
100 Hz, can result in an increase of serotonin production and, therefore, can
be
beneficial in reducing anxiety and depression and, at the same time, augment
sleep. Low frequency CES pulse signals have been found to increase endorphin
production and, therefore, may be beneficial in reducing the perception of
pain.
Typically, electrical stimulation in the form of a square wave pulse signal is
obtained from a computer or a logic port. All logic ports generate digital
"is" and
"Os" where the digital ls have a potential of the power supply voltage, and
the
digital Os are at zero voltage. These voltage transitions are amplified into
much
larger voltages needed to produce the current necessary for biological
stimulation. However, the amplified voltages continue to exactly follow the
digital
signals, unless the digital signals are conditioned.
Digital ports switch at a speed that is typically faster then a microsecond.
Whenever there is a sharp transition or corner in the waveform, harmonics are
4
CA 02707351 2010-06-10
=
=
generated. It is believed that the harmonics, which are produced by the square
wave ls and Os cause a stinging sensation in the skin of a person at the site
of
the electrode which is felt mainly during negative voltage transitions.
It has been determined that much of the sting and discomfort can be
eliminated by rounding the square corner from 10-30% without degrading the
effectiveness of the stimulus.
FIG. 1 is a schematic diagram of a circuit that can be used to round the
corner of a square wave. The square wave signal 10 from a digital port is fed
through a low-pass RC circuit having a resistor 12 and a capacitor 14 to a
switching device 16 to produce a square wave signal 18 having a rounded edge.
The switching device 16 could be a PNP or NPN transistor or a P-Channel or N-
Channel field effect transistor. It can also be an operational amplifier. The
square
wave stimuli signal can be rounded directly or it can be rounded when
connected
to a voltage increasing coil or transformer. FIG. 2 shows the same wave
rounding
circuit of FIG. 1 where the input signal 20 is a pulse-width control signal
and the
output signal is a square wave signal 22 having a rounded edge.
Randomizing Cranial-electro Stimulation at 100 HZ
Cranial-electro Stimulation at 100 HZ has been popularized in a number of
CES devices manufactured in the past 30 years or so. They typically employ a
0.5 msec., negative going (stimulation) pulse that alternates on each ear
every 5
msec., where the cycle is completed every 10 msec., or 100 Hz. The spectral
5
CA 02707351 2010-06-10
=
components of such a technique are 2 Khz from the 0.5 msec. pulse itself and
100 Hz in relation to the 10 msec. stimulus repetition rate.
The problem with this technique is that a degree of habituation occurs with
the steady, repetitive pulse train. By randomly offsetting the alternating
left and
right pulse intervals, randomly from between 1 to 30 seconds, a wide range of
frequency variations are produced which results in an increased effectiveness
for
improving sleep. Referring to FIG. 3, there are shown examples of offsetting
pulses that are applied to the left and right ear lobes of a person. At the
start 50
of the pulse stream, the left (L) and right (R) pulses are evenly timed every
five
milli-seconds. However, at a randomly determined time (52), the left pulse
interval is randomly shortened and the next left pulse, 54 starts a bit
earlier. Now
the left stimuli occurs about 8 msec before the right stimulus. At a random
time
some seconds later, the right stimulus interval at time 56 is increased
causing the
left stimulus pulse to occur about 1 msec before the right stimulus pulse
occurs.
This technique of randomly changing both sides produces harmonics within that
side and between both sides.
Randomizing Low Frequency Cranial-electro Stimulation for Relief of pain.
Presently low frequency stimulation is achieved by stimulating one ear
lobe with one frequency at 0.5 Hz and the other ear lobe at 0.6 Hz, or 0.5 and
0.4
Hz, to generate a 0.1 Hz beat frequency. This beat occurs because, unlike the
short pulses used with the 100 Hz method, in this stimulation method, the
stimulus duty cycle is 50%. Therefore, both the left and right stimuli
constantly
6
CA 02707351 2015-09-29
interact with each other. When the left side has gone negative, the right side
must
be positive in order to complete the current loop. Should the right side go
negative
while the left side is negative, or both sides go positive, the current loop
will stop
and stimulation will cease until the sides are different from each other.
Again, with
this method, habituation occurs and the effectiveness is reduced.
To overcome this, there is disclosed a method where both the left and right
sides independently generate a stimuli signal at random frequencies between
0.5
and 3 Hz from each other. The stimulation signal should not just "jump" from
one
frequency to another which can produce a jittery effect, but the frequency
should
"ramp" up or down in small increments. Over a random period of time, these
small
increments will add up to produce a significant shift that ranges from 0.5 to
3 Hz.
The small increments can be produced with a random number which can be
generated by a microcontroller that indicates the target frequency to
approach. The
stimuli signal will increase or decrease in 0.1 Hz/second increments until the
target
is reached. Upon reaching the target, the stimuli signal will stay at the
target
frequency for a couple of seconds. The timing-loop in software, which is known
to
those familiar with the art, will then be given another random number and the
stimuli
signal will again either increase or decrease at a frequency of 0.1 Hz/second
until
the next target is reached. A random target will be generated in both the left
and
right sides independent of each other. This is graphically shown in FIG.4.
This
method produces a myriad of pulse widths and harmonics, which in turn enhances
the effectiveness of a treatment.
7
CA 02707351 2010-06-10
'
,
,
Randomizing Low Frequency Trans-cutaneous Electro-Stimulation (TENS) for
Relief of Pain
This method employs the same features as explained for Randomizing
Low Frequency Cranial-electro Stimulation for Relief of pain, except that this
is
used on a muscle directly. The pulse width in the case of muscle stimulation
(TENS) is short, (<2 msec), in accordance with standard practices.
Traditional stimulators allow for either the stimulation of the nervous
system (CES) or stimulation of muscle (TENS). It is here disclosed to have two
channels, one channel that provides CES and the associated endorphin
production and the other channel that provides simultaneous treatment of a
muscle. In this case, the CES duty cycle would be at 50% and the TENS pulse
width would be at 2 msec., or less.
Based upon the foregoing, it will be apparent that there has been provided
a new and useful method and system to relieve pain.
While there have been shown and described and pointed out the
fundamental novel features of the invention as applied to the preferred
embodiments, it will be understood that various omissions and substitutions
and
changes of the form and details of the apparatus illustrated and in the
operation
may be done by those skilled in the art, without departing from the spirit of
the
invention.
8