Method and apparatus for administering microcurrent electrotherapy treatment

The present invention relates to a microcurrent electrotherapy device that is pre-programmed to produce a series of different microcurrent waveform signals that are directed to a selected treatment area of a human or animal. More particularly, the electrotherapy device is pre-programmed to produce a sequence of different pulsed and continuous direct microcurrent waveforms. In one programmed mode, the programmed electrotherapy device produces a pulsed direct current waveform of approximately 10 .mu.A to 100 .mu.A which is followed by a second treatment phase of a direct microcurrent of approximately 300 .mu.A to 1000 .mu.A which is followed by a third treatment phase of pulsed direct microcurrent of approximately 50 to 250 .mu.A.

FIELD OF THE INVENTION 
The present invention relates generally to a method and apparatus for 
aiding in pain relief and promoting healing in injured tissues using 
electrical current. More particularly, this invention relates to a 
microcurrent electrotherapy treatment program involving the sequential 
application of at least three different electric profiles and an apparatus 
therefor. 
BACKGROUND OF THE INVENTION 
The application of electrical energy to injured tissues has been an 
acceptable mode of medical therapy for many years and is well 
characterized. For instance, U.S. Pat. No. 4,846,181 to Miller, issued on 
Jul. 11, 1989, lists eleven technical articles on the subject of 
electrotherapy. Those articles suggest, among other ideas, that: 
application of electrical stimulation can promote wound healing; that 
electrical stimulation can be applied to wounds in the presence of saline; 
that low intensity direct current can be utilized as the applied 
electrical stimulation; that applied low intensity direct current 
stimulation can be switched between negative and positive polarities 
during the course of treatment; that high voltage, low amperage galvanic 
stimulation can be applied for short treatment pulses that are 
periodically repeated. 
In addition, several patents have also been issued directed to promoting 
healing by electrical stimulation. Included in these patents are the 
following: 
______________________________________ 
Patent Number Inventor Issue Date 
______________________________________ 
2,099,511 Caesar 11/16/37 
3,918,459 Horn 11/11/75 
3,964,477 Ellis et al 6/22/76 
4,019,510 Ellis 4/26/77 
4,233,965 Fairbanks 11/18/80 
4,312,340 Donadelli 01/26/82 
4,313,438 Greatbatch 02/02/82 
4,314,554 Greatbatch 02/09/82 
4,556,051 Maurer 12/3/85 
______________________________________ 
The above-listed patents include showings that: electrical stimulation can 
utilize preselected treatment times between a few minutes to a few hours; 
the polarity of the active electrode can be switched during the course of 
treatment, and that pulses can be utilized as electrical stimulation. 
U.S. Pat. No. 4,989,605 to Rossen discloses an example of known 
transcutaneous electrical nerve stimulation (TENS) devices. The Rossen 
device outputs between 25 microamps to 9000 microamps of a monophasic 
sequence of bursts of a D.C. carrier signal (10,000 Hz to 19,000 Hz) which 
is modulated off and on in time at a frequency selected from the range 0.3 
Hz to 10,000 Hz. The Rossen device's bursts are characterized as having a 
periodicity greater in duration than that associated with the modulation 
frequency. In addition, Rossen suggests reversing the polarity of the 
electrodes periodically during treatment. 
Another patent, U.S. Pat. No. 5,397,338 to Grey et. al., discloses another 
electrotherapy device for pain control and the promotion of tissue 
healing. The Grey device is capable of operating in either TENS mode, 
Microcurrent Electrical Neuromuscular Stimulation (MENS) mode, or in 
lontophoresis mode. The modes are distinguished from each other based on 
the electrical waveform produced. For instance, the iontophoresis mode 
utilizes D.C. burst waveforms with currents of from 100 microamps to 4 
milliamps. The TENS mode utilizes a positive biphasic or alternating 
monophasic waveform with currents of from 20 microamps to 20 milliamps. 
The MENS mode utilizes a monophasic waveform with currents of from 10 
microamps to 150 microamps. The Grey device is intended as a multi-purpose 
unit capable of operating in various modes without requiring the changing 
of electronic stimulation units or electrodes between modes. However, 
changing from one mode to another in the Grey device is accomplished by 
manually altering switch positions, thus the Grey unit does not 
automatically change from one mode to another. 
Existing electrotherapy methods utilize the above described devices, or 
variations thereof, to subject the tissue to be treated to a particular 
electrotherapy treatment. Typically, these treatments utilize only a 
single waveform and/or current setting for the duration of the treatment. 
SUMMARY OF THE INVENTION 
The present invention improves upon the prior electrotherapy methods by 
subjecting the tissue to be treated to series of waveform/current 
treatment stages so as to better promote healing or pain relief. The 
method of the present invention includes engaging an area of the body to 
be treated with a plurality of electrodes, then treating that area of the 
body by directing in sequence a series of different microcurrent 
treatments to the area being treated. In one embodiment of the present 
invention, a pulsed direct current of between 10 .mu.A and 100 .mu.A 
having a frequency of between 100 and 500 Hz is directed to the treatment 
area during a first treatment stage. In a second treatment stage, a 
continuous direct current of between 300 .mu.A and 1000 .mu.A is applied 
to the area to be treated. In a third treatment stage, a pulsed direct 
current of between 50 .mu.A and 250 .mu.A having a frequency of between 1 
and 10 Hz and a duty cycle of between 30 and 70 percent is directed to the 
treatment area. 
With respect to the method of administering microcurrent electrotherapy to 
a body area, the method of the present invention comprises the step of 
sequentially directing to a body area being treated a series of different 
and programmed microcurrent treatments wherein the programmed microcurrent 
treatments sequentially administered include both a pulsed direct and 
continuous direct microcurrent treatments. 
It is therefore an object of the present invention to provide a 
microcurrent electrotherapy device that is programmed to produce in 
sequence a series of different microcurrent waveforms for treating a 
selected body area of a patient. 
Other objects and advantages of the present invention will become apparent 
and obvious from a study of the following description and the accompanying 
drawings which are merely illustrative of such invention.

DETAILED DESCRIPTION OF THE INVENTION 
FIG. 1 shows the electrotherapy device 10 of the present invention. 
Preferably, the electrotherapy device 10 includes a primary channel 30 and 
a secondary channel 130 encased in an outer shell 20 equipped with a 
primary electrode port 27, and a secondary electrode port 28. 
FIG. 2 shows the basic electronic operating configuration of the primary 
channel 30 of the present invention. The primary channel 30 includes a 
primary electrode port 27, a microprocessor 32, LEDs 34, a beeper 36, and 
a waveform generator 40. Connected to the primary channel 30 are an on/off 
switch 22, input switches 23, 24, 25 (collectively 26), the primary 
electrodes 50, and a power supply 60. The input switches 26 and the on/off 
switch 22 are preferably push button type and resistor multiplexed into an 
analog to digital port of the microprocessor 32. The primary electrodes 50 
can be of any type known in the art of microcurrent electrotherapy; the 
particular details of the electrodes 50 are not necessary to understanding 
the present invention. 
The power supply 60 supplies the microprocessor 32 and rest of the primary 
channel 30 with power. The power supply 60 includes a primary battery 62 
and, optionally, a secondary battery 64. The primary battery 62 supplies 
power to the primary channel 30. If present, the secondary battery 64 
provides power to a secondary channel 130. Turning on the device 10 via 
the on/off switch 22 activates the power supply 60, which in turn controls 
the on/off state of the battery 62. In a preferred embodiment the power 
supply 60 converts the battery voltage to a supply logic level of five 
volts. 
The microprocessor 32 controls and/or monitors voltage, input switches 23, 
24, 25, status LEDs 34, beeper 36, and the waveform generator 40. The 
waveform generator 40 takes signals from the microprocessor 32, transforms 
them into the appropriate microcurrent waveforms, and supplies the 
waveforms to the primary electrode port 27. From the primary electrode 
port 27, the primary electrodes 50 carry the waveforms to the tissue to be 
treated. 
As shown in FIG. 3, the waveform generator 40 preferably includes a voltage 
multiplier 41, a current modulator 42, an integrator 43, and a switched 
bridge 44. The combined portions of the waveform generator 40 take power 
from the power supply 60 and generate a microcurrent electrotherapy 
waveform under direction from the microprocessor 32. 
The voltage multiplier 41 supplies a voltage pumped signal to the switched 
bridge 44. Preferably, the voltage multiplier 41 includes a voltage 
feedback loop with the microprocessor 32. The switched bridge 44 supplies 
the generated microcurrent waveform to the primary electrode port 27. 
Preferably, the switched bridge 44 comprises four opto-isolators in a 
bridge configuration. In addition to the voltage pumped signal from the 
voltage multiplier 41, the switched bridge 44 receives an output polarity 
control signal from the microprocessor 32 and a current modulation signal 
from the current modulator 42. The integrator 43 manipulates the waveform 
signals received from the microprocessor 32 resulting in ramp, sine and 
square wave outputs as required. These outputs are sent on to the current 
modulator 42. The current modulator 42 controls the output current level 
under direction of the microprocessor 32. The current modulator 42 
receives the signals from the integrator 43 and also receives numerous 
current control signals from the microprocessor 32. 
The microprocessor 32 supplies different signals to various portions of the 
waveform generator 40 so as to generate the appropriate microcurrent 
electrotherapy waveforms. For instance, the microprocessor 32 supplies a 
modulated square wave signal to the voltage multiplier 41, an output 
polarity setting to the switched bridge 44, a pulse width modulated 
synthesized waveform to the integrator 43, and a current level selection 
signal to the current modulator 42. 
The primary channel output from the device 10 is to the electrodes 50. 
These electrodes 50 are supplied electrical signals from the waveform 
generator 40 via the primary electrode port 27. The status of the device 
10 is indicated by LEDs 34 which are controlled by the microprocessor 32. 
Also, the device 10 includes a warning beeper 36 which is controlled by 
the microprocessor 32. The warning beeper 36 is activated when the device 
10 detects high resistance between the electrodes 50 of an electrode pair, 
indicating that the electrodes 50 are not making proper contact to the 
portion of the body to be treated. Such a situation is called a pad open 
condition. 
From an inactivated state, the above identified device 10 is activated via 
the on/off switch 22. Once energized, the microprocessor 32 checks the 
other switches 23, 24, 25 to determine which one of various pre-programmed 
treatments has been selected. Based on the program selected, the 
microprocessor 32 sends the appropriate signals to the waveform generator 
40 to cause the appropriate signals to be sent to the electrodes 50. The 
microprocessor also instructs the LEDs 34 and the beeper 36 to indicate 
the appropriate status. Once the selected treatment is completed, the unit 
automatically returns to a ready state. In addition, if the treatment 
selection is changed while another treatment is running, the 
microprocessor 32 will terminate the existing treatment and initiate the 
new treatment program. 
In a preferred embodiment, the device 10 is pre-programmed to provide three 
different treatments depending on which of the input switches 23, 24, or 
25 is selected. Switch 23 causes only a first treatment stage to be 
provided to the tissue to be treated. Switches 24 and 25 cause each of a 
first, second, and third treatment stages to be provided to the tissue to 
be treated and then terminates. Switch 24 provides a lower electrotherapy 
current level and switch 25 provides a higher electrotherapy current 
level. Preferably, the switch 24 current levels are 20 .mu.A for the first 
treatment stage, 400 .mu.A for the second treatment stage, and 60 .mu.A 
the third treatment stage and switch 25 current levels are 20 .mu.A for 
the first treatment stage, 650 .mu.A for the second treatment stage, and 
120 .mu.A the third treatment stage. The waveforms and treatment stages 
are more fully discussed below. 
The description above has focused on the primary channel 30. However, in a 
preferred embodiment, the device 10 also includes a secondary channel 130 
within the same outer shell 20 as the primary channel 30 for 
simultaneously treating a second tissue area. A block diagram of a device 
having both a primary channel 30 and a secondary channel 130 is shown in 
FIG. 4. The secondary channel 130 includes a secondary microprocessor 132, 
a secondary waveform generator 140, secondary LEDs 134, and a secondary 
electrode port 28. The secondary channel 130 communicates with the primary 
channel 30 described above via an opto-isolator 100. The secondary channel 
130 is configured and functions like the primary channel 30 except: 1) 
there are no additional input switches, the input switches 23, 24, 25 for 
the primary channel 30 communicate with both channels and 2) there is no 
additional beeper 36; pad open status for the secondary channel 130 is 
communicated to the primary channel beeper 36 via the opto-isolator 100. 
In addition, the secondary LEDs 134 indicate only battery status of the 
secondary battery 64. The secondary channel 130 has its own battery 64; 
power for the secondary circuit is derived from this battery 64. When the 
battery 64 is present, the secondary channel is activated whenever the 
primary channel 30 is active and supplies the same waveform to its own 
electrodes 150 via the secondary electrode port 28 as the primary channel 
30 provides to its electrodes 50 via the primary electrode port 27. If the 
secondary battery 64 is not present (or is dead), the secondary channel 
130 is not activated. 
The method of the present invention relates to an electrotherapy method 
utilizing at least three different treatment stages applied sequentially 
so as to relieve pain and/or promote healing. During the three treatment 
stages, electrical signals are sent to an area of the body via electrodes 
50, 150 which have been placed on either side of injured or painful 
tissue. The process is designed to function with one electrode pair 50, or 
with a plurality of electrode pairs such as a primary pair 50 and a 
secondary pair 150. For instance, a large area such as a knee might be 
treated with a plurality of electrode pairs, but a small area such as a 
single finger joint might be treated with a single electrode pair. In each 
case, the electrode pair(s) would be disposed such that the tissue to be 
treated would be interposed between the individual electrodes of each 
pair. 
The present inventive method includes steps of arranging electrodes around 
the area of the body to be treated, supplying a first electrotherapy 
waveform in a first treatment stage, supplying a second electrotherapy 
waveform in a second treatment stage, and supplying a third electrotherapy 
waveform in a third treatment stage. After the third treatment stage, the 
process is complete. However, the process could obviously be restarted 
upon completion. 
The first treatment stage is intended to help cleanse the injured tissue of 
toxins. In humans, the first treatment stage is particularly designed to 
stimulate the lymphatic system to facilitate cleansing. During this 
cleansing stage, the electrodes receive pulsed direct current impulses of 
between 10 .mu.A and 100 .mu.A having a frequency of between 100 and 500 
Hz. Preferably, the impulses are of 20 .mu.A at a frequency of 300 Hz. 
While the cleansing stage may last for longer or shorter periods, the 
preferred method is for this stage to last 5 to 10 minutes. 
The waveform for the first treatment stage is shown in FIG. 5(a). The 
waveform for the first treatment stage is a modified square wave. For the 
first portion of each period, the waveform is a square wave characterized 
by a rapid rise to a high current level followed by a hold at that high 
current level. The second portion of each period is a gradual decay from 
the high current level to a level near zero. The waveform then repeats for 
the next period. In a preferred embodiment, the first portion of the 
waveform occurs for approximately 1/3 of the period and the second portion 
of the waveform occurs during the remaining 2/3 of the period. 
The second treatment stage is intended to change the resistance of the 
injured tissue. It has been postulated that injured tissue has a higher 
electrical resistance than healthy tissue such that the flow of electrical 
impulses through an injured section of the body is different from normal. 
It has been further postulated that reducing the resistance back to normal 
would aid the healing process or otherwise reduce pain. To facilitate such 
change in tissue resistance, the electrodes receive a continuous direct 
current of between 300 .mu.A and 1000 .mu.A during the second treatment 
stage. Preferably, the current is between 400 .mu.A and 650 .mu.A. In 
addition, the polarity of the electrodes is preferably reversed at 
periodic intervals during this "charging" stage to avoid acid/base 
build-up in the injured tissue. While the charging stage may last for 
longer or shorter periods, the preferred method is for this stage to last 
10 to 15 minutes. 
The waveform for the second treatment stage is shown in FIG. 5(b). The 
waveform for the second treatment stage includes a non-repeating ramp 
period followed by a level period. The ramp period is preferably 1/2 
second; the level period is preferably the remainder of the second 
treatment stage. 
The third treatment stage is intended to promote healing in the injured 
tissue. During this healing stage, the electrodes receive pulsed direct 
current impulses of between 50 .mu.A and 250 .mu.A having a frequency of 
between 1 and 10 Hz and a duty cycle of between 30 and 70 percent. 
Preferably, the impulses are of 60 .mu.A to 120 .mu.A, at a frequency of 3 
Hz, and a 50 percent duty cycle. While the healing stage may last for 
longer or shorter periods, the preferred method is for this stage to last 
15 to 20 minutes. 
The waveform for the third treatment stage is shown in FIG. 5(c). The 
waveform for the third treatment stage is a square wave of a particular 
duty cycle. For the first portion of each period, the waveform is a square 
wave characterized by a rapid rise to a high current level, a hold at that 
high current level, followed by a rapid return to near zero current. The 
second portion of each period is a hold at near zero current level. The 
waveform then repeats for the next period. The ratio of time at the high 
current level to the time period from one rapid rise to the next rapid 
rise is called the duty cycle. Preferably, the duty cycle is 50 percent, 
meaning that the two portions are of equal duration. 
In a preferred embodiment, the three treatment stages are automatically 
executed sequentially, without any other intervening treatment stages. 
Such an arrangement overcomes problems of user forgetfulness and allows 
for the invention to be used on non-human subjects. 
The description above has assumed that the tissue has been recently 
injured, such as a pulled muscle, or subjected to invasive medical 
treatment, such as reconstructive surgery on a knee. However, the method 
is also useful in treating chronic conditions such as pain from arthritic 
joints. 
The present invention may, of course, be carried out in other specific ways 
than those herein set forth without departing from the spirit and 
essential characteristics of the invention. The present embodiments are, 
therefore, to be considered in all respects as illustrative and not 
restrictive, and all changes coming within the meaning and equivalency 
range of the appended claims are intended to be embraced therein.