Note: Descriptions are shown in the official language in which they were submitted.
CA 02228817 1998-02-OS
BACKGROUND OF THE INVENTION
1. FIELD OF THE INVENTION
The present invention relates to acupuncture therapy and
devices therefor.
2. DESCRIPTION OF THE RELATED AR'r
Acupuncture treatment has been widely used for many centuries
in southeast Asian countries, but has not had the same extensive
use in western culture. Typically, regular acupuncture treatments
require one hour per day and must be performed by a trained
professional over the course of several months by the use of very
small needles. Many patients are not able to tolerate needles, nor
are they able to invest the hour-per-day treatment times.
Conventional acupuncture electrodes tend to deliver a static
or monotonous signal to one more single acupuncture points on a
meridian line. These monotonous signals tend to be filtered out
by the brain after a period ranging from about 2 to 30 seconds in
a process known as 'habituation'.
Acupuncture electrodes have developed such as hand held pencil
shaped probes, as disclosed in tJ.S. Patent 4,180,079 to Wing, or
electrodes which are directly attachable to the body and are thus
stationary during treatment, as disclosed in Canadian patent
1, 202, 683 to Pameranz et al . Pomeranz describes the effects of
'habituation' and proposes to reduce them by changing the gain on
the signal being delivered to hi.s stationary electrodes. Despite
the advances in the electrodes themselves, they still require
professional training and the treatments using these instruments
have shown to provide unsatisfactory results in some cases, because
they tend to deliver a signal which is not sufficiently dynamic to
counter the brain's habituation effects. Nonetheless, acupuncture
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is believed by increasing numbers in western countries to be a
treatment of value.
It is an object of the present invention to provide an
improved device for acupuncture therapy.
SUMMARY OF THE INVENTION
Briefly stated, the invention involves a device for delivering
acupuncture therapy to an acupuncture meridian region of a patient,
comprising;
generating means for generating a signal having at least one
signal'component at a given frequency, the generating means being
operable over a number of successive time periods to change the
given frequency for each of the time periods, the time periods
being sufficiently short to at least partially offset brain-induced
habituation effects in the patient; and
delivery means for delivering the signal to the acupuncture
meridian region.
Preferably, the signal is a train of pulses at a first
frequency, at least some of the pulses further comprising a train
of subpulses at a second frequency and each of the time periods
ranges from about 2 to 30 seconds.
More preferably, the second frequency ranges from about 100
Khz to about 200 Khz and the first frequency ranges from about 1 Hz
to about 100 Hz. Still more preferably, the second frequency
ranges from about 160 Khz to about 170 Khz and the first frequency
ranges from about 1 Hz to 6 Hz and from about 70 Hz to 90 Hz. In
one embodiment, the second frequency signal ranges from about 162
Khz to about 166 Khz and the first frequency is selected from a
group of frequencies comprising 2 Hz, 4 Hz, 77 Hz and 84 Hz.
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In another aspect of the present invention, there is provided
a device for delivering acupuncture therapy to an acupuncture
meridian region of a patient, comprising;
a housing;
generating means contained within the housing for generating
a therapeutic acupuncture signal;
the housing having a support portion to be placed adjacent the
meridian region; the support portion having a plurality of regions
therein, each of which includes a means for delivering the signal
to the meridian region.
Preferably, the support portion includes a lower surface, the
delivery means further including an electrode element positioned
relative to the lower surface. More preferably, the lower surface
further includes a plurality of apertures in the lower surface,
each of the electrode elements being located in one of the
apertures. Still more preferably, the electrode element includes
a conductive surface, the conductive surface being movable relative
to the lower surface. In several preferred embodiments, the
conductive surface is convex and the electrode element is rotatably
mounted relative to the lower surface and is in the shape of a
wheel or a ball.
In still another aspect of the present invention, there is
provided a method for administering acupuncture therapy to an
acupuncture meridian region of a patient, comprising the steps of:
generating a signal having at least one component at a
predetermined frequency;
delivering the signal to the acupuncture meridian region; and
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varying the frequency over successive time periods during the
therapy, the time periods being sufficiently short to at least
partially offset brain-induced habituation effects in the patient.
In still another aspect of the present invention, there is
provided a technique for administering acupuncture therapy to an
acupuncture meridian region of a patient, comprising the steps of:
a) delivering to the meridian region a first pulse train of
electrical pulses at a first frequency, each of the pulses further
comprising a subpulse train of subpulses at a second frequency,
b) varying at least one of the first and second frequencies of
the~pulse train after a predetermined period of time to form a
second pulse train;
c) delivering the second pulse train to the meridian region;
and
d) repeating steps a) to c) through the duration of the
therapy.
BRIEF DESCRIPTION OF THE DRAWINGS
Several preferred embodiments of the present invention will
now be described, by way of example only, with reference to the
appended drawings in which:
Figure 1 is a perspective view of a device for acupuncture
therapy;
Figure 2 is a side view taken on arrow 2 of figure 1;
Figure 2a is a magnified fragmentary perspective assembly view
of a portion of the device illustrated in figure 1;
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Figure 2b is a sectional view taken on line 2b-2b of figure 2a;
Figure 3 is a schematic view of another portion of the device
illustrated in figure 1;
Figures 3a and 3b are schematic views of waveforms generated by
the portion shown in figure 3;
Figure 4 is more detailed schematic view of the portion
illustrated in figure 3;
Figures 5(i) to 5(iv) are detailed circuit diagrams of the
portion illustrated in figure 3;
Figures 5a, 5b and 5c are graphs showing wave forms for signals
generated in the portion of figure 3;
Figures 6a and 6b are more graphs showing wave forms for pulses
generated by the device of figure 1;
Figure 7 is a schematic view of the device of figure 1 one
operative position;
Figure 8 is a sectional view of another device for acupuncture
therapy; and
Figure 9 is a schematic view of another device for acupuncture
therapy in one operative position.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to figure 1, a device is shown at 10 for acupuncture
therapy, having a housing 12 which contains a means for generating
a plurality of stimulating electrical pulses in the form of a
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stimulating pulse generator 14. The housing 12 has a support
portion or lower region in the form of a base 16 with several
delivery regions in the form of apertures 16a through which
projects three movable electrode elements 18, 20, 22, each in the
form of a wheel electrode which i_s suspended for rolling movement
relative to the housing 12 and which i.s provided with a conductive
outer surface 18a to deliver the pulses to the skin of a patient.
Two positive or active wheel electrodes are provided, in this
case wheel electrodes 18 , 20 , as wel l as one negative or common
wheel electrode as shown at 22, thereby allowing the pulses to
travel between the active and common electrodes when the electrodes
are placed in contact with the patient and thereby providing
therapeutic benefit to the regions of the patient's body that lie
therebetween, such as a group of points in one region of an
acupuncture meridian line. In this case, the wheel electrodes have
a fixed distance relative to one another and provide three points
of transfer, two of which are shown at P1 and P2 to transfer the
simulating pulses to the patient:. In this case, the points of
transfer are at a fixed distance relative to one another. The
wheel electrodes are rollable on the skin of the patient, thereby
providing points of transfer that move relative to the patient,
that is between P2 and P3 and P1 and P4 a distance 'D'
respectively. Thus, it will be seen that the device provides
multiple points of transfer which are movable along the skin of the
patient which provides improved therapeutic benefits. In addition,
by virtue of the fact that the electrode wheels are mounted in the
housing of the device, the device may be operated with only one
hand if necessary.
The housing 12 may be compact to be hand-held as shown at 'H'
and can have dimensions of about 14 cm length, 4 cm width and 2 cm
height. The diameter of the wheel electrodes may conveniently be
about 4 cm. The active wheel electrodes may be spaced from the
common wheel electrode by about 10 cm.
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The stimulating pulse generator 14 is coupled to the wheel
electrodes by way of wires shown at 24, 26 to deliver thereto the
stimulating pulses over a predetermined period of time.
Each wheel electrode, as shown for wheel electrode 20 in figures 2a
and 2b, is rotatably mounted to the base 16 by way of an
electrically conductive bearing assembly including a block 20a with
a lateral bore 20b which is dimensioned to receive one of a pair of
shafts 20c extending from the wheel electrode. The wheel electrode
is electrically conductive and is formed from a brass alloy with an
electroplated gold layer on its outer surface as shown at 20d to
enhance the transfer of the electrical signal to the patient as
will be explained. Each block is mounted to the base by way of a
pair of threaded fasteners, one of which also receives a coupling
with the cable 26.
The wheel electrode may also be formed of other materials,
provided they have a conductive outer surface. For example,
plastic moulded with conductive layer which is fully or partially
covering the wheel electrode's outer surface.
The stimulating pulse generator 14 generates a pulse train of
stimulating pulses at a first frequency. Each of these pulses
further comprise a subpulse train of subpulses at a second
frequency. As will be described, the pulse generator varies the
first and second frequencies, in a manner to deliver a dynamic
pulse train to the patient through the electrodes in a manner which
is believed to provide therapeutic benefits.
Referring to figure 3, the pulse generator 14 includes a
signal generating unit 28, with five outputs 28a to 28e, to
generate a plurality of relatively low frequency digital signals,
in this case 4, and at least one relatively high frequency digital
signal, a modulator unit 30 for modulating each of the relatively
low frequency signals with the relatively high frequency signal,
thereby to form a pulse train as shown in figure 3a having a pulse
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duration of 'ta' and a period 'Ta'. Each pulse in turn is a
subtrain of subpulses shown in figure 3b with a subpulse duration
of 'tb' and a period 'Tb'. The modulator unit 30 includes four
output channels 30a to 30d, each of which carries a corresponding
pulse train thereon.
Each of the channels is joined to a designated input of a
multiplexing unit 32 which in turn applies successive pulse trains
one-by-one from selected ones of the channels to an output circuit
34, over a predetermined period of time. The output circuit
converts the pulse trains to a stimulating pulse train, that is
with a strength capable of delivering therapeutic benefits, and
conveys the stimulating pulse trains to the wheel electrodes.
A schematic view of the stimulating pulse generator 14 is
shown in figure 4. The signal generating unit 28 has an oscillator
crystal 50 which generates a 4.096 Mhz output which is coupled with
a frequency divider 52 (IC4060) which acts as crystal buffer and
has a first 250 Hz frequency output which is coupled to an input of
a 12 stage frequency divider 54 (IC4040). The latter generates
four outputs having digital signals with 0.125, 0.0625, 2 and 4 Hz
respectively, each of the 2 and 4 Hz outputs having a 'duty cycle'
of 50 percent, that is, it has a 1 to 2 ratio between the length or
duration of the 'on' state of the signal and the length or duration
of the period of the signal, that is including both the 'on' and
'off' states. The 0.125 and 0.0625 Hz outputs are provided as
driver signals and are coupled directly with two inputs of the
multiplexing unit 32 (IC4052). The 2 and 4 Hz outputs are coupled
directly with two designated inputs of the modulator unit 30.
The frequency divider 52 has a second 1000 Hz output which is
also coupled with an input of a decoder 56 (IC4017) to generate a
76.92 Hz output with a 23 percent duty cycle, while the first 250
Hz output is also coupled to an input of a decoder 58 (IC4017) to
generate an 83.33 Hz output with a 33 percent duty cycle. The
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76.92 and 83.33 Hz outputs are coupled to two additional designated
inputs of the modulator unit 30.
The frequency divider 52 has a third 4.096 Mhz output which is
S coupled to a frequency divider 60 (IC4060) to generate an 819200 11z
output, which is in turn coupled to the input of a decoder 62
(IC4017) to generate a 163840 Hz output (hereinafter referred to as
the 164 Khz output) with a 20 percent duty cycle. The output of the
decoders is also coupled to a designated input of the modulator
unit 30.
The modulator unit 30 is arranged to modulate the 164 Khz signal
with one of the 2, 4, 77 and 84 Hz frequencies to form four
modulated pulse trains. These four modulated pulse trains are
conveyed to the multiplexing unit 32 through four output channels
30a to 30d in the form of output terminals l, 2, 3 and 4. The
waveforms of these outputs are illustrated in figures 5a to 5c
where, in each case, the pulse train has a relatively low frequency
in which each pulse includes a subtrain of subpulses, themselves
having a relatively high frequency, and in this particular case 164
Khz. Signal pattern I corresponds to 4 Hz at a duty cycle of 50
percent, signal pattern II corresponds to 2 Hz at a duty cycle of 50
percent, signal pattern III corresponds to 76.92 Hz at a duty cycle
of 23 percent, signal pattern IV corresponds to 83.33 Hz at a duty
cycle of 33 percent and signal pattern V corresponds to 163830 Hz at
a duty cycle of 20 percent.
The multiplexing unit 32 is driven by the 0.25 and 0.125 Hz
signals from the Frequency divider 58 and couples one of the four
inputs with its single output in a predetermined sequence, that is
from input 1, 2, 3 and 4 in a predetermined pattern and switches the
input coupling after a time period of 4 seconds, that is 2 Hz, 4 Hz,
77 Hz, 84 Hz, then repeats again.
Referring to figures 5(i) to 5(iv), the modulator 30 is
shown with four AND
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gates 30a, each of which receives one of the four relatively low
frequency signals, namely 2, 4, 77, 84 Hz, on one input and the
relatively high frequency signal, namely 164 Khz, on the second
input. The multiplexer 32 output Y is coupled to the output
circuit 34 via a transistor shown at 34a and thereafter is directed
to two transformer units shown at 34b, 34c. Each transformer has
a secondary, each of which is coupled to an active wheel electrode
as shown at 18, 20, to deliver a bipolar pulse train as shown at
figure 6a, 6b. An indicator light is also provided at 34d as an
indication of the frequency of the pulse train being delivered to
the wheel electrodes at particular period of time.
The interval or time period of 4 seconds was calculated by
considering the approximate speed of the device during use as the
device is passed over the skin of the patient at an approximate
speed of 1.5 cm/sec, the distance between the wheel electrodes is
about 10 cm. Therefore, it was calculated that the signal
simulates every point for about 3.5 seconds and a 4 second
switching between frequencies allows even low frequency signals to
be applied for a sufficient amount of time. The change of the
pulse train is provided by the 4 second change of state at input
'A' and the 8 second change of state at input 'B' on the
multiplexer 32. However, the time period may be other than 4
seconds, such as between 2 and 30 seconds, so that it is
sufficiently short to at least partially offset brain-induced
habituation effects in the patient.
Referring to figures 6a, 6b, the amplitude of the pulse should
be such to provide an effective pulse while taking into account
factors that may influence the effective delivery of a therapeutic
pulse to the patient, such a:~ losses that may arise at the
connection of the wheel electrode surface with the output circuit
and at the boundary of the wheel electrode surface and foreign
material on the wheel electrode surface or on the skin of the
patient, such as perspiration and dirt. Preferably, the pulse
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has sufficient strength to penetrate the skin of the patient at a
depth of between 0.5 and 0.7 cm without causing skin damage such as
burning. For example, the amplifier unit may be configured to
provide the pulse with an amplitude swing in the order of about 9
volts with a maximum amplitude swing in the order of about 150 rnA.
The device is operated in the following manner. First, a
desired group of points are identified on the patient along a
particular acupuncture median line such as in the upper abdominal
region identified in figure 7. The device is placed on the patient
so that the meridian line is located between the two active wheel
electrodes and with the common wheel electrode placed in a region
adjacent the meridian line, for example directly on the meridian
line ats shown at A in figures 7. The device is then activated,
causing a train stimulating pulses to appear at the wheel
electrodes as described above . ~'he device may then be moved slowly
in a reciprocating fashion along a particular region, for example
within six inches, as shown at B, on either side of the desired
group of points.
Thus, the device provides for a technique for administering
acupuncture therapy to an acupuncture meridian region of a patient,
comprising the steps of:
a) delivering to the meridian region a first pulse train of
electrical pulses at a first frequency, each of the pulses further
comprising a subpulse train of subpulses at a second frequency,
b) varying at least one of the first and second frequencies of
the pulse train after a predetermined period of time to form a
second pulse train:
c) delivering the second pulse train to the meridian region;
and
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d) repeating steps a) to c) through the duration of the
therapy.
The high frequency subtrain can be seen as an agent to
facilitate the penetration of the low frequency signal through the
skin of the patient while the low frequency pulses provide
therapeutic benefits, depending an their frequency. For example,
the 2 and 4 Hz frequencies are believed to induce the production of
natural pain killers known as 'endorphins', one of the
'enkephalins' produced by the body. The 77 Hz frequency is
believed to produce other enkephalins and is believed to be a
stress relieving agent, while the 84 Hz frequency is believed to
have similar therapeutic benefits of the 77 Hz frequency.
It has been determined that the stimulation of several
acupuncture points along any given meridian line on the body either
at the same time or in reasonably short intervals therebetween is
believed to be more effective than the stimulation of one or a
group of such points in the conventional static manner using a
single electrode for each such paint and this can be explained as
follows. If an electronic acupuncture signal is applied to any
acupuncture point for a long period of time, the brain 'habituates'
that is it tends to filter out any such monotonous signal.
Depending on the patient, it has been found that this brain-induced
habituation can occur after a range of about 2 to 30 seconds.
In the case of the above device, the signal is a pulse train
at one relatively low frequency, wherein each pulse is itself
another subtrain of subpulses at a relatively high frequency. The
frequency of the pulse train changes over time and thus adds one
dynamic variable to counter the habituating influence of the brain.
Furthermore, the points of transfer between the wheel electrodes
and the patient change as the wheel electrodes roll, thereby adding
a second dynamic variable to counter the habituating influence of
the brain. Two pulse trains leave the two active electrodes,
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penetrating the skin and progressing to the common electrode,
passing through the desired group of points along the way in a
manner which is believed to cause release of endorphins and other
therapeutic benefits. Thus, the range of points being treated is
constantly changing as the device is moved along the skin of the
patient.
The processes of acupuncture, electro-acupuncture and TENS
stimulate of a natural pain response mechanism, causing the release
of pain relieving chemicals of a class known as opioid peptides, of
which endorphins is just one. It has been shown that the body
releases a class of chemicals known as 'endopeptidase', which
destroys the endorphins after a relatively short period of time.
It ~is~ believed that, the signal emitted by standard fixed
electrodes causes this pain response mechanism, the consequence
being that therapeutic benefits of the endorphins are short lived
by the destructive effects of the endopeptidase.
The present device is believed to stimulate different
acupuncture points by moving back and forth along the meridian
lines, in a manner which is believed to at least partially offset
the brain-induced habituation effects in the patient. Moreover,
by stimulating one region and then returning to that same region a
relatively short time thereafter, the device and its treatment is
believed to repeat or reset the body's pain response mechanism
causing, once again, the release of the body's natural pain
killers, thereby increasing the overall quantity of endorphins
available to the body for pain relief.
The device does not require the placement of needles, nor the
attachment of electrodes. Rather, the device need only be placed
in contact with the skin of the patient in the desired meridian
line region with an appropriate electrode cream if necessary and
therefore does not necessarily require extensive professional
training for its use. The signals, in the device of figure 1,
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deliver the pulse signals simultaneously to the two active wheel
electrodes. However, it may be beneficial to provide different
signals to each of the active wheel electrodes, depending on the
treatment.
While the device shown in figure 1 has two active wheel
electrodes and one common wheel electrode, other configurations are
also contemplated such as the use of more than two active wheel
electrodes as well as two or more common wheel electrodes. rigure
8 is a cross sectional view of a device 100 having a housing 102,
a base 104 and a number of rollers, two of which are shown at 106,
The rollers are supported in conductive bearings 108 which are
coupled to a pulse generator 110 in the manner above described for
device~l0. Similar in most other respects to the device 10 shown
above, the device 100 is not confined to uniaxial reciprocal
movement as shown in figure 7 , but rather may be used in a circular
reciprocal movement as shown in figure 9.
Thus, the multiplexing unit functions as a means for varying
the pulse by switching the output signal between a sequence of
input signals. Each input signal is generated by the modulator
unit which modulates one relatively low frequency signal with one
relatively high frequency signal. The modulator unit, if desired,
may be configured to add one ar more relatively low frequency
signals with the one relatively high frequency signal or may
instead use one or more relatively high frequency signals, again
depending on the therapeutic effect being desired.
Preferably, the train o.f pulses have relatively low
frequencies in a range between about 1 Hz to 100 Hz, more
preferably from about 1 Hz to 6 Hz and from about 70 Hz to 90 Hz,
and specifically for the above device, frequencies of about 2 Hz,
4 Hz, 77 Hz and 84 Hz and each subtrain of subpulses have a
relatively high frequency in a range of between about 100 and 200
Khz, more preferably between about 160 Khz and 170 Khz, still more
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preferably between about 162 Khz and 166 Khz and in the present
case about 164 Khz. These specific frequencies have been selected
because they are believed to provide certain therapeutic benefits,
that is by triggering the patient's body to release its own defence
mechanisms, such as endorphins anc~ the like. Other frequencies may
also be used either with or without these selected frequencies,
depending on therapeutic treatment desired. The therapeutic
effects of the pulse signal can a7_so be varied by changing the duty
cycle of one or more of the frequency components.
While the multiplexing unit applies one of the four inputs
with its single output in a predetermined sequence, the
multiplexing unit may couple the inputs in another manner such as
by using a random sampling unit to randomly select one of the
inputs over a regular interval. Furthermore, the multiplexing unit
may switch from one randomly se_Lected input to another randomly
selected input in a randomly sE:lected period of time within a
normal operating period, say for example 4 seconds.
While the devices shown herein switch the pulse train
frequencies every four seconds, other time periods may be used such
as in a range from about 2 to 30 seconds.
While the device shown herein makes use of electrical pulses
for treatment, it may be configured to provide magnetic or other
pulses in a similar manner. In addition, the waveforms of the
pulses may indeed be other shapes than those shown herein and may
include sharp peaks or be sinusoidal rather than rectangular as
shown herein.
While each of the pulses in the pulse trains described above
include a subtrain of subpulses, it should be recognized that
significant therapeutic benefit may be available by providing a
number of pulse trains as described above and then one or more
relatively constant pulses, repeated by a number of pulse trains
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again as described above.
While the above devices make use of a number of circuit
components, it will be understood and that advances in electronics
may result in circuit optimizatian and a reduction in the number of
components needed. For example, a microprocessor may be used
either with a frequency generating crystal or an on-board frequency
generating capability, without the need of separate frequency
dividers as described.
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