Executive Summary of The Tens Machine

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Tens Machine
This project, a tens machine from 1989, shows how to design and build a transcutaneous electrical
nerve stimulator machine.

Executive Summary of the Tens Machine

An improved transcutaneous electrical nerve stimulator (TENS) involving a microcurrent (typically 25


to 900 microamps) monophase D.C. carrier signal (typically 10,000 to 19,000 Hz, preferably 15,000
Hz) that is modulated on and off in time (typically at 0.3 Hz up to 10,000 Hz, preferably 9.125 Hz
followed by 292 Hz) and further inverted about every second by reversing the polarity of the signal at
the electrodes. Such a device has been found to be useful in alleviating pain very rapidly.

Background of the Tens Machine

1. Field of the Design

This design relates to an improved transcutaneous electrical nerve stimulation (TENS) apparatus for
symptomatic relief and management of chronic (long term) intractable pain and adjunctive treatment
in the management of postsurgical traumatic acute pain. More specifically, the design relates to a
TENS device that operates in the electrical current range of about 25 microamps to less than 1
milliamp using a chopped (e.g., 9.125 Hz or 292 Hz) carrier frequency (e.g., 15,000 Hz) having
typically a monophasic wave profile which is preferably inverted (reversed polarity) approximately
every second.

Summary of the Tens Machine

The improved transcutaneous electrical nerve stimulator according to the present design is
categorically a microcurrent TENS which operates using a unique wave form. The instrument is
constructed such that it will operate from about 25 microamps up to about 900 microamps current
during therapeutic use with a peak current of the order of 6 milliamps.

Typically the current is applied through a pair of electrodes in the form of a high frequency,
monophasic, burst of a D.C. carrier signal (e.g., at lest 10,000 Hz to 19,000 Hz)that is chopped or
modulated at a relatively lower frequency (e.g., from about 0.3 Hz up to 10,000 Hz). The burst of the
modulated carrier signal are typically from about 0.05 seconds to about 10 seconds in duration with
about one second in duration being preferred.

Preferably, successive bursts are inverted relative to the previous burst by reversing the polarity at
the electrodes thus simulating a biphasic wave form, yet the carrier is a monophasic D.C. signal.
Preferably, the modulating frequency is selected from pairs of frequencies which exhibit specific
therapeutic action (e.g., 292 Hz and 9.125 Hz).

Advantageously the TENS can be performed synchronously with light stimulation and has been found
to relieve pain extremely fast (typically in 1 to 3 minutes) under conditions that are below the level of
human sensation.

Thus the present design provides an improved transcutaneous electrical nerve stimulator comprising:

(a) a pair of electrode means for making surface contact and supplying electrical current to
mammalian tissue; and

(b) an electrical circuit means for supplying to the pair of electrode means from about 25 microamps
up to about 900 microamps of a monophasic sequence of bursts of a D.C. carrier signal selected from
the frequency range of at least 10,000 Hz to about 19,000 Hz which is modulated on and off in time at
a frequency selected from the range of about 0.3 Hz up to 10,000 Hz and said bursts are
characterized as having a periodicity greater in duration than that associated with the modulation
frequency.

Preferably the microcurrent TENS device inverts the D.C. carrier signal between bursts by reversing
the polarity at the pair of electrodes means. Most preferably this occurs about every second with the
modulating frequency being selected from the group consisting of 9.125, 18.25, 73, 146, 292, 584,
168, 2336, and 4672 Hz with a D.C. carrier frequency of typically 15,000 Hz.

For routine pain management the use of 9.125 Hz followed by 292 Hz is particularly useful. The
present design also provides a unique LED electrode that produces electromagnetic radiation
synchronously with the electrical current therapy.

Description of the Tens Machine

The improved microcurrent transcutaneous electrical nerve stimulator according to the present design,
how it operates and how it is used, how it differs from previously known instruments and the
advantages of using the improved device can perhaps be best explained and understood by reference
to the drawings.
Figure 1 : Is a perspective view of a transcutaneous electrical nerve stimulation apparatus
according to the present invention for the tens machine

FIG. 1 illustrates one particularly preferred embodiment of the present design wherein the TENS unit
(generally designated by the numeral 10) consists of a portable housing 12 with two external
electrodes 14 and 16. In this particular embodiment the case or housing 12 is equipped with a clip 18
that allows the unit to be worn on the belt or the like during use.

The other side of the case 12 relative to the belt clip 18 is equipped with a slot 20 that allows a sliding
selector switch 22 to be used to set the beat frequency (i.e., the modulating frequency for turning the
carrier signal on and off at a predetermined frequency characteristic of the therapeutic treatment
being performed).

In this particular illustrated embodiment only two frequency settings are available to the user
(typically 9.125 Hz or 292 Hz). As such this particular embodiment is easily operated by the patient.
In a more complex embodiment, a greater number of preselected discrete frequency settings are
provided (for example, by making the slot 20 of the sliding selector switch 22 longer) thus producing a
clinical or physician's version of the instrument.

The top face of the case 12 is further provided with an on/off switch 24 and a monitor light 26 along
with an electrical current selector switch 28. Also there are two electrode connector terminals 30 and
32 provided on the top face of the case 12 which in this illustrated embodiment involve two separate
types of energy emitting electrode systems.

The first system involves two electrically conductive electrodes 34 and 36. Electrode 34 is a
conventional self adhering neurostimulation electrode which is adhesively pressed to the skin or the
like. The second current electrode 36 is a conductive pad that represents the outer skin contacting
surface of both the second electrical current electrode and the light emitting diode (LED) system (the
second type of energy emitting electrode system).

As shown in FIG. 1, there is a set of four light emitting diodes 38 protruding through the current
carrying electrode surface 36. Thus, in this particular embodiment, both the unique electrical wave
form of the present design and synchronous light radiation can be simultaneously applied
transcutaneously at the same physical location.

Typically this second electrode 36 is held adhesively to the skin or the like during use by the use of a
transparent, conductive, double adhesive electrode patch (not shown).

The actual use of the TENS unit 10 illustrated in FIG. 1 is relatively simple and straightforward. The
electrodes, typically either a pair of self adhering neurostimulation electrodes of approximately 32
millimeters in diameter such as supplied by Axelgaard Manufacturing Co. of Fallbrook, Calif., or one
such electrode plus the specialized light/current electrode of FIG. 1 adhesively held by a 38.4
millimeter in diameter model 4.times.4sp electrode patch supplied by AcuData Software Medical
Products Division of Petaluma, Calif., are positioned on mammalian skin tissue in accordance with a
health care professional or physician's instructions.

During use there are only two adjustments that need to be made. The current selector switch 28 on
the top face of the housing 12 can be adjusted from 25 microamps up to a 6 milliamp peak output.
The frequency selector 22 can be positioned wither high, e.g. 292 Hz, or low, e.g. 9.125 Hz.

The on/off switch 24 when turned on will activate the on light 26 which flashes or blinks faster as the
current setting is increased. As such, visual confirmation of the instrument being on and the particular
current setting can be readily determined by looking at the light 26. During use the current can be
adjusted by the user by use of switch 28.

Typically the current is initially elevated until the perception of electrical stimulation is perceived. The
current is then decreased until perception of stimulation is undetectable. Readjustment during
treatment can be repeated as needed. Typically a setting of about three tenths of full scale for switch
28 represents an optimum effective setting.

One particularly preferred method of use for pain involving muscle spasms, tightness or chronic
problems, starts with 9.125 Hz and the current turned up until it can be felt. The current setting is
then lowered until the sensation is gone. The current is continuously lowered each time the sensation
of stimulation becomes apparent until a setting is found where no further sensation appears for two
minutes.

The TENS unit is then switched to the high frequency setting. For acute pain such as post surgical pain
or pain involving inflammation and/or swelling rather than muscle tightness or spasm, start with 292
Hz. Such procedures have been found to alleviate pain in as little as 1 to 3 minutes.

Application of the TENS unit for periods in excess of twenty minutes is not generally needed although
longer or even continual stimulation may be beneficial in selected cases.
Figure 2 : Is a block diagram illustrating the functional components making up a typical
electrical circuit according to the present invention for the tens machine

FIG. 2 is a block diagram of the individual components making up a typical electrical circuit for the
embodiment of the TENS device shown in FIG. 1. The respective function of the individual components
are indicated on the block diagram. As shown, the device is powered by a battery 40 supplying current
to a voltage step-up converter 42.

The voltage step-up converter typically produces a 30 volt source which is part of a precision constant
current source 44 (for details see FIG. 2). The 30 volt is applied to the skin and a precision constant
current sync regulates the current through the skin.

As further illustrated on the left side of FIG. 2, the electrical circuit involves a modulation oscillator 46,
a carrier oscillator 48 and a bi-phase oscillator 50. The bi-phase oscillator 50 is typically a 0.05 second
to 10 second oscillator that drives a polarity switcher 52 which in turn reverses the polarity of the
current supplied by the precision constant current source 44 at the current electrodes 54 and 56.

The carrier oscillator 48 is typically a 10,000 Hz to 19,000 Hz signal (preferably about 15,000 Hz)
generator that drives one of the input sides of the gating circuit 58. The modulation oscillator 46 and
frequency divider 60 are the source of the beat frequency that chops the carrier frequency on and off
in time at preselected frequencies known to be beneficial for therapeutic purposes.

As suggested in FIG. 2, the output from the frequency divider 60 is either 292 Hz or 9.125 Hz. This
signal drives both the LED driver 62 and the other input side of the gating circuit 58. The LED driver
62 then drives the LED electrode 64 at the selected frequency synchronously with the current
electrodes 54 and 56.

The gating circuit 58 output is directed through attenuator 64 before the signal is directed to the
precision constant current source 44 and polarity switcher 52. The output from the attenuator is also
used to drive the feedback monitor LED flasher 66 thus alerting the patient that the TENS device is
operating by flashing at a rate proportional to the current.

Figure 3a : Is a detailed schematic of the electronic circuit of one preferred embodiment


according to the present invention for the tens machine

Figure 3ab : Is a detailed schematic of the electronic circuit of one preferred embodiment
according to the present invention for the tens machine
Figure 3b : Is a detailed schematic of the electronic circuit of one preferred embodiment
according to the present invention for the tens machine

FIG. 3A, FIG. 3AB, and FIG. 3B show a detailed schematic of one preferred embodiment of the
electrical circuitry according to the present design. This particular circuitry is generic to both the 292
Hz/9.125 Hz modulated embodiment of FIGS. 1 and 2 as sell as the physician's version having eight
different selectable modulation frequencies.

In presenting the schematic of FIG. 3, conventional electrical notation is employed to identify all
components and relevant electrical component values. A single 9 volt portable radio type battery is
employed as the current source. The following table of components categorizes and identifies the
individual elements and associated circuitry corresponding to the functional block circuit description of
FIG. 2.

TABLE
______________________________________
(FIG. 2) (FIG. 3)
______________________________________
Battery, 40 BT1 9V Alk
Voltage Step-Up Converter, 42 U2, Q10, L1
Precision Constant Current Source 44 U3, Q2
Modulation Oscillator, 46 U1
Carrier Oscillator, 48 U4D
Bi-Phase Oscillator, 50 U4B
Polarity Switcher, 52 V4A, Q5-9
Current Electrodes, 54 & 56 J2
Gating Circuit, 58 U4C
Frequency Divider, 60 U1
LED Driver, 62 Q1
Attenuator, 64 Q3, VR1
Feedback Monitor LED Flasher, 66 V5 (vco)
______________________________________

Figure 4 : Is a simplified illustration of the essential features of the unique wave form of the
electrical signal employed according to the present invention for the tens machine

FIG. 4 illustrates the essential features of the unique wave form of the electrical signal employed in
the improved TENS according to the present design. As illustrated the vertical axis is D.C. current
wherein the center line represents ground and the displacement upwards represents one polarity and
displacement downward represents the inverse or reverse polarity at the pair of conductive electrodes.

The horizontal axis is time. As seen in FIG. 4, the instantaneous current at maximum power is plotted
as a function of time with insufficient resolution to perceive the carrier frequency (i.e., typically 15,000
Hz). What can be clearly seen is the inversion or more specifically the reversing of polarity at the
electrode approximately every second in this specific illustration.

Also, the monophasic character of the D.C. carrier signal is evident in that during any given one
second burst of the 15,000 Hz carrier signal, current flows in only one direction (i.e., amplitude either
above or below the center ground but not both). The on/off time modulation of the carrier signal at
9.125 Hz is suggested in that a sequence of 110 millisecond bursts chops the one second interval into
approximately 9 cycles with approximately 50% duty cycle (i.e., current transmission during half of
the cycle).

In the case of 292 Hz a 3.4 millisecond burst chops the one second into 292 cycles. As further
suggested in the first reversed polarity modulation cycle a burst of the 15,000 Hz carrier frequency
would represent some 822 individual pulses within a given duty cycle at 9.125 Hz or 25.7 individual
pulses, at 292 Hz.
As further suggested in FIG. 4, the normal treatment range is confined to a current of up to about 900
microamps which is represented in the drawing as a central band well below the maximum current
amplitude of 6 milliamps. It should be appreciated that the illustration of FIGS. 4 and 5 are not to
scale and will vary depending on the selection and rate of polarity reversal at the electrodes.

Figure 5a : Illustrate the circuitry associated with the novel led/current electrode according
to the present invention for the tens machine
Figure 5b : Illustrate the circuitry associated with the novel led/current electrode according
to the present invention for the tens machine

FIGS. 5a and 5b illustrate the printed circuit associated with the novel combined LED/current electrode
according to the present design. As illustrated in FIG. 5a, the back side of the printed circuit involves
leads 68 and 70 which connect fours LED's (not shown) in series. The other leads 72 supply current to
the tissue contacting current electrode 74 of FIG. 5b.

Current electrode 74 is provided with four openings for insertion of the LED's into the light emitting
circuitry 68 and 70. This circuit board is then incorporated into an appropriate housing as illustrated in
FIG. 1.

The advantages of the improved TENS unit according to the present design are viewed as being
numerous and significant. The fact that the unit is a microcurrent TENS powered by a single 9 volt
battery means the unit is highly portable, readily serviceable and safe under all normal operating
conditions.

The fact that the polarity at the electrodes is systematically reversed reduces the likelihood of any
detrimental tissue damage in the vicinity of the electrodes. In this regard reversal of polarity every
0.05 seconds up to about 10 seconds (preferably from about 0.1 seconds to 8 seconds and most
preferably about every second) is useful for purposes of this design but other periodical reversal
schemes including asynchronous, random and-or time delayed or interruption of the carrier signal
should be considered equivalent.

The unique wave profile results in extremely fast management of pain under treatment conditions that
are virtually undetectable to the user. And, the overall therapeutic procedure is highly compatible with
simultaneous treatment using IR and near IR pulsed therapy again accelerating the process of pain
management.
Having thus described and exemplified the preferred embodiments with a certain degree of
particularity, it is to be understood that the design is not to be limited to the embodiments set forth
herein for purposes of exemplification, but is to be limited only by the scope of the attached claims,
including a full range of equivalents to which each element thereof is entitled.

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