U.S. patent application number 13/336608 was filed with the patent office on 2012-04-26 for device and method for the treatment of pain with electrical energy.
This patent application is currently assigned to NewLife Sciences, LLC. Invention is credited to Daniel H. Schumann.
Application Number | 20120101549 13/336608 |
Document ID | / |
Family ID | 37781671 |
Filed Date | 2012-04-26 |
United States Patent
Application |
20120101549 |
Kind Code |
A1 |
Schumann; Daniel H. |
April 26, 2012 |
DEVICE AND METHOD FOR THE TREATMENT OF PAIN WITH ELECTRICAL
ENERGY
Abstract
An electronic pain treatment device delivering electrical energy
to the tissue of a patient in pain is provided which includes a
variable wave generator, an impedance measurement circuit, and at
least one electrode probe. Associated methods for treating pain are
also disclosed.
Inventors: |
Schumann; Daniel H.; (Lake
Forest, CA) |
Assignee: |
NewLife Sciences, LLC
Merrimack
NH
|
Family ID: |
37781671 |
Appl. No.: |
13/336608 |
Filed: |
December 23, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11594389 |
Nov 8, 2006 |
8108047 |
|
|
13336608 |
|
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|
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60735156 |
Nov 8, 2005 |
|
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Current U.S.
Class: |
607/46 |
Current CPC
Class: |
A61H 39/002 20130101;
A61N 1/0472 20130101; A61N 1/36021 20130101; A61B 5/053
20130101 |
Class at
Publication: |
607/46 |
International
Class: |
A61N 1/34 20060101
A61N001/34 |
Claims
1-10. (canceled)
11. A method for relieving pain comprising the following steps: (a)
providing means for locating first and second trigger points on
painful innervated tissue of a patient; (b) placing a first
electrode on the first trigger point and a second electrode on the
second trigger point; (c) measuring an impedance of the tissue
between the two electrodes; (d) providing means for determining a
treatment time period; (e) treating the patient by supplying
electrical energy to the tissue via the electrodes in the form of a
pulsed electric waveform during the treatment time period; (f)
measuring an impedance of the tissue between the two electrodes;
(g) evaluating an impedance change; and, (h) providing means for
determining whether steps e-g are repeated.
12. The method of claim 11 wherein the means for locating the
trigger points further comprises the steps of: palpating areas
indicated by the patient to elicit the patient's qualitative
indication of the most painful spots; and, confirming the
qualitative indication of the most painful spots by measuring the
impedance there between and comparing it with impedance readings
taken for other nearby spots.
13. The method of claim 11 wherein the means for determining
whether steps e-g are repeated further comprises the step of
comparing the last measured impedance to a first pre-selected
impedance value and ending the treatment when the measured
impedance falls below the first pre-selected impedance value.
14. The method of claim 11 wherein the means for determining
whether steps e-g are repeated further comprises the step of
comparing the impedance change during the last treatment to the
impedance change during the treatment immediately prior to the last
treatment and ending the treatment when the difference between the
two impedance changes falls below a second pre-selected impedance
value.
15. The method of claim 11 wherein the means for determining
whether steps e-g are repeated further comprises the step of
comparing at least two impedance measurements taken after the last
treatment to determine the tendency of the impedance to increase
between measurements and ending the treatment when the rate of
change of impedance between measurements falls below a pre-selected
impedance rate of change value.
16. The method of claim 11 wherein the means for determining
whether steps e-g are repeated further comprises the steps of:
comparing the last measured impedance to a first pre-selected
impedance value and ending the treatment when the measured
impedance falls below the first pre-selected impedance value;
comparing the impedance change during the last treatment to the
impedance change during the treatment immediately prior to the last
treatment and ending the treatment when the difference between the
two impedance changes falls below a second pre-selected impedance
value; and, comparing at least two impedance measurements taken
after the last treatment to determine the tendency of the impedance
to increase between measurements and ending the treatment when the
rate of change of impedance between measurements falls below a
pre-selected impedance rate of change value.
17. The method of claim 14 further comprising: placing two
electrodes on the skin of the patient adjacent to a site of a
medical procedure selected from the group consisting of injection,
incision, and surgery: supplying electrical energy to the site of
the medical procedure via the electrodes for treating pain caused
by the medical procedure.
18. The method of claim 17 wherein the treatment for pain begins
before said medical procedure.
19. The method of claim 11 further comprising: placing two
electrodes on the skin of the patient adjacent to a site of an
injury; supplying electrical energy to the site of the injury via
the electrodes for treating pain caused by the injury.
20. A method for relieving pain comprising the following steps:
providing means for locating first and second trigger points on
painful innervated tissue of a patient; placing a first electrode
on the first trigger point and a second electrode on the second
trigger point; treating the patient by supplying electrical energy
to the tissue via the electrodes in the form of a pulsed electric
waveform; providing means for identifying the shape of the
waveform; identifying a transition of a portion of the waveform
from a square-like wave having two peaks to a triangle-like wave
having a single peak; and, ending treatment after the transition to
the triangle-like wave has occurred.
21. The method of claim 20 further comprising; locating the
electrodes at trigger points identified by the patient; and,
confirming the location of the trigger points based on one or more
impedance measurements.
Description
PRIORITY CLAIM
[0001] This application claims the benefit of U.S. provisional
patent application 60/735,156 filed Nov. 8, 2005 entitled DEVICE
AND METHOD FOR THE TREATMENT OF PAIN WITH ELECTRICAL ENERGY.
FIELD OF THE INVENTION
[0002] The present invention relates to devices and methods for the
treatment of pain. In particular, the present invention relates to
devices and methods of treating pain via administration of specific
electrical energy to trigger points.
BACKGROUND OF THE INVENTION
[0003] Pain is a major medical problem. Best estimates are that
nearly 120 million Americans suffer from chronic pain; at least 10%
of these individuals are in serious pain (50 mm or more on the 100
mm visual analog scale [VAS]) despite all treatment. Studies show
that many pain sufferers, particularly those suffering from chronic
pain, cannot be treated effectively. The effects of ineffective
treatment include reduced mobility, limited function, poor sleep
and low quality of life. For many, chronic pain is truly
devastating.
[0004] In addition, current methods for the treatment of chronic
pain often have undesirable effects. For instance, the typical oral
or topical administration of a drug can result in widespread
systemic distribution of the drug and undesirable side effects.
Epidural blocks are of uncertain effectiveness and can be only
given a limited number of times. Surgery is employed to treat many
forms of pain but recent studies shoo outcomes are uncertain, and
surgery is expensive and invasive.
[0005] Electricity has been used to treat pain for many years,
starting with the ancient Egyptians who used electric eels from the
Nile to treat pain. In theory, treatment of pain by electricity or
electrical means could have advantages compared with current
alternatives, in that it would provide relief in a non-invasive
manner without side effects. Currently, Transcutaneous Electrical
Nerve Stimulation (TENS) is used as a palliative treatment for
pain. This technology, which inputs electricity using conductive
adhesive pads over painful sites, stimulates certain nerve fibers
and is theorized to close a pain "gate" between the painful site
and the brain. In so doing it blocks the sensation of pain.
However, once the device is turned off and the pads removed the
pain "gate" opens and the sensation of pain returns. Thus TENS,
while useful in treating pain in the short-term, does not have a
lasting effect.
[0006] What is needed is a method of treating pain that is
long-lasting, and that does not have the drawbacks of current
treatment methods such as surgery, epidural blocks or drugs.
SUMMARY OF THE INVENTION
[0007] The electronic pain treatment device of the present
invention, combined with its method of application, provides an
effective, lasting and non-surgical means of treating pain. The
electronic pain treatment device administers electrical energy, of
a specific electrical waveform and generated by the device, to
trigger points associated with the pain.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 depicts one embodiment of the electronic pain
treatment device of the present invention.
[0009] FIG. 2A depicts a schematic diagram of one embodiment of the
conduction/impedance measurement circuit (FIG. 2A) of the
electronic pain treatment device of FIG. 1.
[0010] FIG. 2B depicts a schematic diagram of one embodiment of the
treatment output circuit (FIG. 2B) of the electronic pain treatment
device of FIG. 1.
[0011] FIGS. 3A-J depict electrical waveforms of the treatment
output of the electronic pain treatment device of FIG. 1.
[0012] FIG. 4 depicts a probe tip of the electronic pain treatment
device of FIG. 1.
[0013] FIGS. 5A-C depict a multi-function probe assembly of the
electronic pain treatment device of FIG. 1.
[0014] FIGS. 6 and 7 depict a compound probe assemblies of the of
the electronic pain treatment device of FIG. 1.
[0015] FIG. 8 depicts a roller type probe assembly of the
electronic pain treatment device of FIG. 1.
DETAILED DESCRIPTION OF THE INVENTION
[0016] The electronic pain treatment device of the present
invention, combined with its method of application, provides an
effective, lasting and non-surgical means of treating pain. FIG. 1
shows an embodiment of the electronic pain treatment device 100
which administers electrical energy, of a specific electrical
waveform and generated by the device, to trigger points of the
human body associated with the pain. The electronic pain treatment
device of the present invention is useful for the treatment of pain
including, but not limited to, acute, chronic and post-surgical
pain. As shown in FIGS. 2A & B, an embodiment of the invention
comprises a variable wave generator 202, an impedance or
conductivity measurement circuit 204, a minimum of two electrode
probes 206a, b (or a single multi-electrode probe) and various
controls and accessory equipment, including an amplitude control
208a, b and a polarity control 209.
[0017] Trigger points are discrete, focal, hyperirritable spots
located in a taut band of skeletal muscle. They produce pain
locally and in a referred pattern and often accompany chronic
musculoskeletal disorders. Acute trauma or repetitive microtrauma
may lead to the development of stress on muscle fibers and the
formation of trigger points. Patients may have regional, persistent
pain resulting in a decreased range of motion in the affected
muscles. Palpation of a hypersensitive bundle or nodule of muscle
fiber of harder than normal consistency is the physical finding
typically associated with a trigger point. Palpation of the trigger
point will elicit pain directly over the affected area and/or cause
radiation of pain toward a zone of reference and a local twitch
response. Every muscle has a potential trigger point. When this
trigger point flares up, goes into spasm and becomes painful, often
that one trigger point radiates its pain to another, satellite
point. The combination of the trigger point and satellite point are
referred to as a set of trigger points. A more complete description
and mapping of trigger points can be found in Myofascial Pain and
Dysfunction: The Trigger Point Manual by Travell and Simons
(Waverly Press, 1983).
[0018] The electronic pain treatment device of the present
invention 100 can take various forms. Exemplary, non-limiting
examples include: (1) a main console 114 with at least two
electrode probes 110a,b that connect to the console via a wired or
wireless connection (see, for example, FIG. 1), and optionally one
or more remote controls 116 that connect to the console via a wired
or wireless connection; (2) a set of probes connected to each other
with a wired or wireless connection, and optionally one or more
remote controls that connect to the probes in a wired or wireless
fashion, but no main console (see, for example, FIGS. 5A-C); and
(3) a single, self-contained compound probe assembly (see, for
example, FIGS. 6-8) and optionally one or more remote controls that
connect to the probe assembly via a wired or wireless
connection.
[0019] The compound probe assemblies of FIGS. 6-8 having electrodes
614a-c may or may not be self-contained and are useful for treating
pain in specific local areas with or without precisely locating
trigger points. Such probe assemblies may be used to treat small
areas that are presenting pain, or as a local pain reduction device
when giving injections, making incisions, or other painful
procedures (see FIGS. 6-8 for probe providing opening for
injections). This assembly (or the probes described above) may also
be moved along a painful area while the device is in treatment mode
in order to treat large, painful areas. For example, the electrodes
could be moved along a wound or incision that is healing in order
to reduce the associated post-operative pain. In an embodiment, the
electronic pain treatment device of the present invention 100 can
be used as described above to reduce pain in innervated tissues
such as tissues having inflammation, bruising or swelling
associated with injuries or surgery.
[0020] In an embodiment, the electronic pain treatment device of
the present invention 100 administers therapeutic electrical
energy, of specific and predetermined electrical waveforms,
generated by the device, to trigger points associated with the
pain. And in some embodiments of the device of the present
invention, the device incorporates at least two probes. And in an
embodiment, one probe, referred to here as the primary probe 110a,
includes a control 112 that signals activation of the therapeutic
electrical output as well as other controls 108, indicators, and/or
displays 504. In an embodiment, a "trigger" type switch 505 is used
to activate the therapeutic output. The second probe is referred to
here as the secondary probe 110b. The probes and probe tips 214a, b
are of a specific form that is designed to comfortably focus the
electrical energy on the trigger points. Because it has been
discovered that the facility to reverse the polarity of the
electrical output is desirable, the device is configured such that
the probe electrical polarity can be reversed enabling both points
within the trigger point set targeted for treatment to be treated
equally without the need to physically reverse the probes. As shown
in FIG. 2B, an embodiment of the invention utilizes a center tapped
transformer 212 in combination with a SPDT switch activated by a
polarity control 209 to accomplish this function. Other embodiments
of this polarity selection feature will also be known to persons of
ordinary skill in the art; for example, a DPDT switch could also be
used.
[0021] In an embodiment of the electronic pain treatment device of
the present invention 100, the device has three active modes. First
is the "idle mode" wherein the device is active but does not
provide electrical output to the probes. The second mode is a
"measurement mode" or a "reading mode" wherein a small amount of
electrical current is administered between the probes to measure
conductivity of innervated tissue, such as human tissue, between
the probes. The third mode is a "treatment mode" wherein the
electrical wave shape and amplitude (i.e., waveform) available at
the probe tips 214a, b are sufficient to be therapeutically
effective in treating pain. In alternative embodiments,
measurements are taken or not taken when in "treatment mode."
[0022] In one embodiment of the electronic pain treatment device of
the present invention 100, treatment progress is monitored via a
conductivity indication such as from a meter or conductivity
indicating device 212 indicating conductivity, resistance or
impedance that is incorporated into the device. When in measurement
mode, the electronic pain treatment device administers a small
direct or alternating current between the probe tips or electrodes
214a, b and utilizes ratios between indicated voltage and current
to provide an indication of the conductivity, such as impedance, of
the tissue between the probe tips. Typically, before any treatment
is applied, the tissue conductivity in the painful area is measured
and noted. As treatment proceeds, additional conductivity
measurements are periodically taken, and increases in tissue
conductivity are expected. Increased conductivity is a consistent
marker for immediate reductions in perceived pain. The goal of
treatment is to maximize conductivity (minimize impedance) and, as
the treatment progresses, to achieve persistent high conductivity
measurements. For example, where the electrodes are spaced apart by
about 50 mm, initial conductivity measurements in the range of
about 1.times.10 -8 to 1.times.10 -7 Mhos may be expected,
depending on the area being treated. And, during the course of
treatment, conductivity increases in the range of about 20 to 500%
may be expected, depending on the area being treated. As a person
of ordinary skill in the art will recognize, the type and state of
tissue being treated and the spacing between the electrodes may
result in different ranges; for example, electrodes which are more
closely spaced will likely result in higher conductivity
readings.
[0023] Once the conductivity is maintained at the higher level for
a predetermined period of time, the treatment session is concluded
for that trigger point set. In an embodiment, time periods
indicating the desired persistence of higher conductivity
indications are typically in the range of about 5 to 20 seconds.
Such persistence indicates that the treatment will alleviate the
pain for a substantial time period discussed more fully below.
During a single treatment session, a single trigger point set may
be treated or a plurality of trigger point sets may be treated.
[0024] The probe tips 214a, b are made of a conductive material
such as stainless steel or another conductive metal, non-metal or a
matrix including one or both such as a carbon fiber matrix. In an
embodiment, the probe tip is a small, rounded tip to allow focused
application of the electrical signal. In another embodiment, the
probe includes a hemispherical tip with a radius of about 0.125
inches (see also FIG. 4). In yet other embodiments the radius may
vary between 0.100 and 0.500 inches. And in some embodiments, an
electrode incorporates a conductive roller or wheel 614c allowing
the probe to be moved easily along a painful area such as alongside
the site of an incision.
[0025] The conductance/impedance measurement circuit and/or
amplifier 215 and treatment circuit 216 of the electronic pain
treatment device of the present invention 100 are depicted in FIGS.
2A and 2B. In an embodiment, the indications of conductance or
impedance may be taken when the double pole, double throw (DPDT)
switch 218 interconnects the primary probe 110a with the
conductance/impedance measurement circuit 215 and interconnects the
secondary probe with a current source 220 (as shown). And when the
DPDT switch is in an alternate setting, the primary probe is
interconnected with the treatment circuit 216 and the secondary
probe is interconnected with the treatment circuit.
[0026] The electrical output of the electronic pain treatment
device of the present invention 100 comprises specific electrical
wave shapes of variable amplitude. In an embodiment, the wave shape
is akin to a pulse whose shape changes as a function of the
impedance of the skin or other tissue under treatment (material
between the electrode probe tip 214a, b). FIGS. 3A-J represent a
series of waveforms or pulses generated by an embodiment of
electronic pain treatment device of the present invention. In this
embodiment, the electrodes are placed on the skin of a patient. The
highest voltage in the pulse is indicated by V.sub.H; the lowest by
V.sub.L, and the final voltage before the next pulse begins is
indicated by V.sub.F. The period is indicated by the symbol lambda
(.lamda.). The pulse duration is indicated by P. At high impedance
(approximately 1 M.OMEGA. or more) a first portion of the wave is
square-shaped and has two distinct peaks; an adjacent portion of
the wave is a damped sinusoid (see, for example, FIG. 3A). As the
impedance value reduces, damping of the sinusoidal portion
increases (see, for example, FIGS. 3B-3D). At mid-level impedance
(approximately 100 K.OMEGA. ), one of the peaks becomes less
distinct and damping of the sinusoidal portion is increased (see,
for example, FIG. 3E). As the impedance value continues to reduce,
the first portion of the wave begins to take on the shape of a
triangle wave and damping of the sinusoidal portion is increased
(see, for example, FIGS. 3F-3I). At low impedance (approximately 5
K.OMEGA. or less) the first portion of the wave appears as a
triangle wave and the sinusoidal portion of the wave is over-damped
(see, for example, FIG. 3j). The frequency of the pulses may be
varied from 1 Hertz (Hz) to 10,000 Hz and the peak amplitude of the
pulses may be varied from 0 to 500 volts. The pulse duration, P,
may be varied from 0 milliseconds up to the output's period
(.lamda.), which would vary depending on the frequency of the
output in a range from about 0.1 millisecond to 1.0 second.
[0027] In another embodiment, the electronic pain treatment device
of the present invention 100 has an electrical output with a
variable frequency and amplitude but a fixed fundamental wave shape
(for example, a square wave). And in some embodiments, the
treatment output has a wave shape that varies with impedance to
form one or more of or a composition of a staircase wave, triangle
wave, or sine wave.
[0028] When the therapeutic output is activated, the output can
reach the set amplitude and current in a few milliseconds, or it
can ramp up to this level more slowly. In an embodiment, the
ramp-up time is variable between 20 milliseconds and 10 seconds and
in another embodiment between 20 milliseconds and 1 minute. Some
embodiments limit the voltage to a range of about 0 to 120 volts
and the current to a range of about 0 to 10 milliamps. In order to
prevent sudden changes to the electrical output that could occur as
a result of sudden changes in tissue conductivity, one embodiment
of the treatment circuit 216 of the present invention provides a
current change-rate limiter to limit to pre-selected values the
maximum rate of current change (measured in milliamps/second).
Another embodiment of the treatment circuit 216 of the present
invention provides a voltage change-rate limiter to limit to
pre-selected values the maximum rate of voltage change (measured in
volts/second). And in yet another embodiment of the treatment
circuit 216 of the present invention, the maximum rate of current
change (milliamps/second) is adjusted downward as the conductivity
of the tissue between the electrodes increases. In some
embodiments, the maximum rate of current change is inversely
proportional to conductivity and in other embodiments the maximum
rate of current change is adjusted to limit to predetermined values
the power dissipated in the tissue as a function of
conductivity.
[0029] In an embodiment of the present invention 100, the
electrical output when taking impedance readings includes a direct
or alternating current signal variable between about 0 and 100
Volts. And in an embodiment, the setting for this electrical output
for human tissue is about 5.2 Volts.
[0030] When the electrical pain treatment device of the present
invention 100 is inactive, it provides no electrical output. When
active, but not in treating mode (this is referred to "reading
mode" or "measurement mode"), the device is electrical output is a
direct or alternating current output that is used to determine the
impedance of the tissue or material between the probe tips 214a, b.
These readings range from 0 Ohms (shorted probe electrodes) to
values approaching infinite Ohms (electrodes with airgap
between).
[0031] These impedance readings can be displayed in one or more
forms, including, but not limited to, a numeric, graphic, other
visual, or audible forms. In an embodiment, the output display is
located on the main console 102 and in another embodiment on a
remote display/output 502, 504. Display scales include one or more
of a linear scale such as a linear scale of 0-100, a logarithmic
scale, an exponential scale or another suitable scale known in the
art. Impedance reading displays include those displayed with
discrete units (Ohms, etc.), or on a relative/dimensionless scale.
In an embodiment, these readings are sent to a computer for
analysis, storage, display, and the like.
[0032] Impedance readings are used to determine the state of the
tissue under test and/or treatment. A reduction in impedance
(increase in conductivity) during or after treatment indicates the
treatment is reducing the level of pain perceived by the patient
under treatment. In an embodiment, the device takes these impedance
readings only when in reading mode, and in another embodiment, the
readings are taken only when in treatment mode. In yet another
embodiment, the impedance readings may be taken in both modes. In
this embodiment, automation of the treatment method is enabled
since trending of impedance values during treatment allows for
control of the treatment duration. In another embodiment,
identification of the shape of the waveform allows identification
of the transition of a first portion of the waveform from a
square-like wave having two peaks to a triangle-like wave having a
single peak which signals the end of the treatment.
[0033] Where the device does not take impedance readings when in
treatment mode, some embodiments provide a display indicating
(numerically and/or graphically) the last reading taken before the
device was switched from reading to treatment mode, and/or a series
of past readings.
[0034] In an embodiment, a counter displays the elapsed time since
the device was switched from reading to treatment mode
(essentially, "treatment duration"). And in an embodiment, the
counter resets automatically when the device is switched back to
reading mode. In some embodiments, the counter holds its value when
reading and resets before the next treatment begins.
[0035] In yet other embodiments of the electronic pain treatment
device of the present invention 100, components including, but not
limited to, counters and/or data collection devices are included to
measure parameters such as, but not limited to, total treatment
time during the patient's office visit, total reading time during
the patient's office visit, total treatment time during the
patient's cumulative course of treatment (numerous doctor visits),
total reading time during the patient's cumulative course of
treatment (numerous doctor visits), total treatment time over the
life of the device, total reading time over the life of the device,
total number of treatment sessions over the life of the device,
total hours of "switched on" time over the life of the device, the
locations of the treatment points where the patient was treated
over the cumulative course of treatments (numerous doctor visits),
and other patient-specific data.
[0036] The data generated by the electronic pain treatment device
of the present invention 100 can be stored on a computer in
electronic form and used to provide medical professionals involved
in the care or evaluation of patients information, including, but
not limited to, session summaries, and overall course of treatment
summaries. Such summaries are useful for numerous purposes,
including but not limited to patient-specific analysis, billing
support, and clinical trials. In some embodiments, these data are
displayed on the device, printed out, stored, and/or transmitted to
other systems.
[0037] The electronic pain treatment device of the present
invention 100 includes a plurality of control actuators which can
be operated by the patient or the device operator (typically, a
medical professional), or they may be computer-controlled. The
control actuators can take the form of any device known in the art
which is effective to control an electrical output, including, but
not limited to, one or more of knobs 104, sliders, dials or
thumbwheels 108, buttons 106, 504, switches 112 or other similar
control actuators actuating controls including one or more of
analog switches, digital switches, potentiometers,
encoders/decoders, or the like. Control actuators actuate controls
suitable for controlling parameters of the electrical output and
other interfaces of the electronic pain treatment device of the
present invention, including, but not limited to the following.
[0038] Frequency Adjustment: adjusts the output signal's frequency
across its range. [0039] Amplitude/Intensity Adjustment: adjusts
the amplitude of the output wave. [0040] Stop Treatment/Amplitude
to Zero Control: sets the amplitude to zero when activated. [0041]
Volume Adjustment: adjusts the volume of the conductivity reading
audio output. [0042] Tone Adjustment: adjusts the tone of the
conductivity reading audio output. [0043] Display Adjustment:
adjust the intensity/contrast/color/etc. of the electronic pain
treatment device's displays. [0044] Polarity Switch, such as a
two-position switch or a/b toggle that reverses the polarity of the
treatment probes. This has the same effect as switching the probes
with each other, but without interrupting the treatment or moving
the probes. [0045] Data Interface, such as analog or digital
input/output via one or more wired or wireless interfaces such as
802g, USB or ethernet interface.
[0046] The above controls can be located in locations on the device
including, but not limited to, on the main console 114 of the
device; on one of the treatment probes 110 (wireless or
non-wireless) or on a remote control 116 (wireless or
non-wireless). In an embodiment, certain controls are operated by
the device operator and in another embodiment, the same or fewer
than the same controls are operated by the patient. And in an
embodiment having redundant controls (such as a redundant
adjustment control located on the main console, one of the probes,
and/or a remote control), a controller incorporated in the device
determines which control or control actuator is active. A typical
controller includes an A/B or A/B/C, etc. selector switch for
providing, inter alia, a scheme whereby all controls are active, a
scheme whereby some of the controls are active, and a controller
scheme with a hierarchical logic to determine which subset of
controls or control actuator is active. In an embodiment, a
controller scheme determines that if a remote is present, then the
remote control is active and other controls are not; or, if there
is no remote present, then the control on the main console is
active. In another embodiment of the electronic pain treatment
device of the present invention, an indicator to indicate which
control is active is present. An exemplary indicator is a lamp or
similar light-emitting device. Also, an indicator lamp may be used
to indicate whether the treatment is active/on or inactive/off.
[0047] In an embodiment, the medical professional may operate all
of the controls on the device 100. And in an embodiment, the
intensity of the electrical output is selected by the patient
(using one or more of the amplitude, frequency, or a combined
amplitude and frequency adjustment). Here, the patient is
instructed to set the intensity at a point where he or she strongly
feels a tingling sensation but is not feeling pain from the
treatment; this provides the patient the means to treat the pain
aggressively but safely and comfortably (see earlier discussion of
current and voltage limiting) while ensuring that future treatments
are not suppressed by memories of a painful experience when another
operated these controls. Frequency and/or amplitude adjustments
that result in the "tingling sensation" vary for different
patients. Typically, the frequency adjustment is set in the range
of about 1 to 10,000 Hz and the amplitude adjustment is set in the
range of about 0 to 500 volts.
[0048] In an embodiment, the method of treatment disclosed herein
consists of a single treatment session. In yet another embodiment,
the method of treatment discussed herein comprises a series of
treatment sessions. Notably, the administration of electrical
energy as described above has been found to have an unexpected
generally cumulative effect. In some embodiments of the method of
the present invention, multiple treatment sessions can take place
24-72 hours apart, preferably at least about 24 hours apart.
[0049] The number of treatment sessions necessary to treat an
individual patient is to be determined by a medical professional.
In one non-limiting example, a series of treatment sessions in a
range from two to twelve sessions is appropriate. It is also within
the scope of the present invention to provide additional treatment
sessions, including weekly sessions for a prolonged period of time,
months or years or occasional sessions over similar time
periods.
[0050] During treatment of pain with the electronic pain treatment
device of the present invention, communication between the patient
and the medical professional is necessary to evaluate the
perceptions of comfort of the patient. And, in initiating a
treatment session, it is recommended to determine precisely where
the pain is; in most cases the patient can be quite specific about
the location of the pain. After locating the painful spot or area,
the primary probe tip 214a,b is placed on this location (the
trigger point) and the secondary probe tip is placed on an
associated satellite or involved point. The satellite location is
located by locating a second nearby trigger point using the methods
discussed herein. When the treatment begins, communication with the
patient should continue; the patient should be asked whether they
believe the correct location is being treated. Patients often can
sense whether the appropriate area is being treated. If the patient
is certain the area being treated is not the right area, a
different area should be selected for treatment, preferably with
the patient's assistance.
[0051] When a set of trigger points has been treated, the patient
is typically asked whether the treatment seems to have helped.
Especially in the first treatment, one of the medical
professional's goals is to find those trigger points where
treatment is most effective. This can take some time and for that
reason the first treatment session in a series of treatments
generally requires 25% to 50% more time than subsequent sessions of
typically 5 to 15 minutes per trigger point treated.
[0052] In most cases, the treatment is carried out on trigger point
sets adjacent to or on the site of the painful location. These
trigger point sets can be found manually as described above and/or
with the aid of the conductivity meter 212. Manually located
trigger point locations can also be confirmed by use of the
conductivity or impedance indicating meter; for example impedance
values obtained from a tissue sample which is not in pain may be
compared to impedance values obtained from manually located trigger
sets. Locating trigger point sets is thus aided by both
conductivity and/or impedance measurements and palpation or
application of pressure in painful areas identified by the
patient.
[0053] A goal of the treatment with the electronic pain treatment
device of the present invention 100 is to improve the conductivity
of the painful area. An initial conductivity measurement is taken
before treatment; then the site is treated for about 1 minute, and
the conductivity is measured again. If the conductivity has not
increased (impedance decreased), the treatment may not have
occurred on the proper points; if so, the probes typically should
be relocated as described above. If there is an increase in
conductivity, the treatment should continue for about 30 seconds
and then the conductivity should be measured again. It may be
necessary to adjust the amplitude or frequency of the electrical
output to prevent the treatment from becoming uncomfortable for the
patient as the tissue's impedance changes. Treatment is continued
until the conductivity no longer increases and the conductivity
stays at or near the highest achieved level for about 10 seconds.
At this time, the pain is reassessed and either the next set of
trigger points is identified and treated or, where beneficial, as
may be indicated by the patient, the polarity is reversed and
treatment of the same trigger points continues.
[0054] In an embodiment, after treating a pair of sites with the
primary probe on the most painful site and the secondary probe on
an adjacent, or satellite site, the probe polarity is reversed
(using the polarity switch) and the treatment regime described
above continues until conductivity is increased by about 20 to 500%
FIG. 2A depicts a schematic diagram of one embodiment of the
conduction/impedance measurement circuit (FIG. 2A) and treatment
output circuit (FIG. 2B) of the electronic pain treatment device of
FIG. 1. This ensures that both sites receive therapeutic
treatment.
[0055] After treating the initial painful points one may find that
the pain has "moved." Patients may indicate that the pain at the
first spot has abated and that it has moved to a new, often close
by, location. In fact, what has happened is that, once the original
painful location has been treated, the patient is now aware of pain
that was masked by that of the original painful location. Because
of this phenomenon, it is typical to spend time "chasing the pain"
around one or more specific areas. It is also typical that chasing
the pain occurs less frequently as the course of treatment
progresses. As the goal is to eliminate "the pain," the treatment
continues while the pain is chased until no further painful
locations present themselves. This chasing technique requires
frequent communication with the patient.
[0056] While the patient may be feeling substantially better at
this point, this improvement may or may not persist and it should
be expected that additional treatment sessions may be required to
eliminate and/or manage the pain. In many treatment regimes,
follow-up visit/treatment sessions will be scheduled to occur
within 24 to 72 hours from the time of initial treatment
session.
[0057] While the electronic pain treatment device of the present
invention and associated methods of treatment, have thus far been
described with regard to its use in a non-invasive manner, it is
within the scope of the present invention to use the device, and
the associated methods, during surgery, as an implantable device,
in wound healing and in other instances. Such other instances
include use of the present invention for wound healing, bone
healing, macular degeneration and multiple sclerosis.
[0058] In another embodiment of the electronic pain treatment
device of the present invention 100, a monitoring system 221 is
provided to control and/or monitor the usage of the device. The
monitoring system is useful to monitor the number of uses of the
device including dispensing uses, storing information on uses and
storing and obtaining credits for the use of the device. One use
can represent different parameters and any of the following types
of "use" can be monitored with the monitoring system of the present
invention. A use, or one use, may include, but is not limited to, a
specific amount of time during which the device is active or
enabled, a specific amount of time during which the device is in
treatment mode; a specific amount of electrical power used, one
complete treatment session, and the like. In an embodiment, uses
are quantified and controlled by use credits which are electronic
units of use that are purchased enabling operation of the
device.
[0059] In one embodiment of the present invention, where a "use" is
determined by a specific amount of time (for example, active time,
enabled time, measurement time, or any combination of these or
other parameters), an "extend treatment" function may be employed
that enables the user to extend the treatment for a specific amount
of time without using an additional use credit. In some
embodiments, the "extend treatment" function is used with a
cumulative electrical energy administered use-measurement
system.
[0060] In another embodiment of the present invention, the medical
professional who administers treatment using the electronic pain
management device 100 purchases use credits which allow the use of
the device. For example, the medical professional purchases ten use
credits and the monitoring system 221 of the electronic pain
treatment device tracks the consumption of these credits. After ten
uses of the device, the medical professional is required to
purchase additional credits to continue use of the device. The
monitoring system thereby limits use of the device to users having
use credits.
[0061] In yet another embodiment of the present invention, the
monitoring system 221 includes systems for controlling the number
of uses of the electronic pain treatment device during a particular
period of time. In this embodiment of the monitoring system, the
medical professional purchases from the device's manufacturer a
fixed number of uses as discussed above. A system for storing,
tracking and dispensing the uses includes but is not limited to, at
least one of the following: card readers such as Smartcards,
standard magnetic cards, optical cards, etc.; a plug in dongle or
cartridge; a link to a computer system from which credits for use
are downloaded; a keypad or other input device; and other devices
as are known to those skilled in the art.
[0062] Methods for tracking the uses and use credits include but
are not limited to, a device, including a remote device or integral
device, which displays the number of use credits available to the
user of the device, a printed document which displays the number of
available use credits, a computer-based system which displays and
tracks the number and use of use credits.
[0063] Unless otherwise indicated, all numbers expressing
quantities of ingredients, properties such as molecular weight,
reaction conditions, and so forth used in the specification and
claims are to be understood as being modified in all instances by
the term "about." Accordingly, unless indicated to the contrary,
the numerical parameters set forth in the following specification
and attached claims are approximations that may vary depending upon
the desired properties sought to be obtained by the present
invention. At the very least, and not as an attempt to limit the
application of the doctrine of equivalents to the scope of the
claims, each numerical parameter should at least be construed in
light of the number of reported significant digits and by applying
ordinary rounding techniques. Notwithstanding that the numerical
ranges and parameters setting forth the broad scope of the
invention are approximations, the numerical values set forth in the
specific examples are reported as precisely as possible. Any
numerical value, however, inherently contains certain errors
necessarily resulting from the standard deviation present in their
related test measurements.
[0064] The terms "a" and "an" and "the" and similar referents used
in the context of describing the invention (especially in the
context of the following claims) are to be construed to cover both
the singular and the plural, unless otherwise indicated herein or
clearly contradicted by context. Recitation of ranges of values
herein is merely intended to serve as a shorthand method of
referring individually to each separate value falling within the
range. Unless otherwise indicated herein, each individual value is
incorporated into the specification as if it were individually
recited herein. All methods described herein can be performed in
any suitable order unless otherwise indicated herein or otherwise
clearly contradicted by context. The use of any and all examples,
or exemplary language (e.g. "such as") provided herein is intended
merely to better illuminate the invention and does not pose a
limitation on the scope of the invention otherwise claimed. No
language in the specification should be construed as indicating any
non-claimed element essential to the practice of the invention.
[0065] Groupings of alternative elements or embodiments of the
invention disclosed herein are not to be construed as limitations.
Each group member may be referred to and claimed individually or in
any combination with other members of the group or other elements
found herein. It is anticipated that one or more members of a group
may be included in, or deleted from, a group for reasons of
convenience and/or patentability. When any such inclusion or
deletion occurs, the specification is herein deemed to contain the
group as modified thus fulfilling the written description of all
Markush groups used in the appended claims.
[0066] Preferred embodiments of this invention are described
herein, including the best mode known to the inventors for carrying
out the invention. Of course, variations on those preferred
embodiments will become apparent to those of ordinary skill in the
art upon reading the foregoing description. The inventor expects
skilled artisans to employ such variations as appropriate, and the
inventor intends for the invention to be practiced otherwise than
specifically described herein. Accordingly, this invention includes
all modifications and equivalents of the subject matter recited in
the claims appended hereto as permitted by applicable law.
Moreover, any combination of the above-described elements in all
possible variations thereof is encompassed by the invention unless
otherwise indicated herein or otherwise clearly contradicted by
context.
[0067] It is also to be understood that the embodiments of the
invention disclosed herein are illustrative of the principles of
the present invention. Other modifications that may be employed by
persons of ordinary skill in the art are within the scope of the
invention. Thus, by way of example, but not of limitation,
alternative configurations of the present invention may be utilized
in accordance with the teachings herein. Accordingly, the present
invention is not limited to that precisely as shown and described,
but is that which is described by the appended claims.
EXAMPLE
[0068] A group of forty patients experiencing chronic pain have
received cutaneously administered treatment using an embodiment of
the device and method of the present invention. The device included
probes, a treatment circuit and an impedance measurement circuit.
Pain levels indicated by relative impedance were recorded using a
100 mm Visual Analog Scale (VAS).
[0069] The treatment methodology for all patients included
assessment of patient pain level, initial location of trigger point
sets, placement of the probes on the trigger points, initial or
base line impedance measurements (inverse of conductivity),
administering the therapeutic output, measuring impedance, and
receiving patient feedback.
[0070] The assessment of patient pain level prior to treatment was
done using the 100 mm Visual Analog Scale, where the patient marked
his or her own pain level along the 100 mm scale with values of 0
representing "no pain" and 100 representing "the worst pain
imaginable." A typical pain level for untreated patients was 70
mm.
[0071] Locating trigger points began with the patient's indication
of the painful area. Palpation by the medical professional was used
to confirm the general location and also to locate the most painful
spot within that area. Continued palpation in the region around the
trigger point was used in conjunction with patient feedback to
locate a satellite point or second nearby trigger point. Having
located the trigger point set, a first probe was placed on one
trigger point and a second probe was placed on the other trigger or
satellite point.
[0072] The initial or baseline impedance was measured by applying a
DC voltage of between 2 and 10 volts to establish a current flow
through the tissue between two electrodes. From this, the impedance
measurement circuit calculated the impedance of the tissue between
the electrodes and displayed a relative indication on the
display.
[0073] Initially, the therapeutic output of the device was set to
administer a series of pulses at a frequency in the range of 450 to
500 pulses per second. The voltage was adjusted from zero upwards
until the patient perceived a tingling sensation, generally in the
range of 0 to 120 volts. The therapeutic output so adjusted was
applied for about 60 seconds. If the treatment begins to become
more painful for the patient, the voltage and/or frequency was
adjusted to ensure that discomfort was minimized.
[0074] Impedance measurements were made following the initial
application and typically showed a reduction in impedance. The goal
of the treatment during each patient visit was to decrease the
impedance (increase the conductivity) through successive
applications of the therapeutic output to achieve a persistently (5
to 20 seconds) lower level of impedance. When successive treatments
showed little or no impedance change, the patient's treatment
session for that office visit was ended, or in cases, a second set
of trigger points was treated.
[0075] Because it was found that the effects of multiple treatments
were cumulative, patients were treated in multiple office visits
and some patients made as many as twelve such visits for treatment.
Patient feedback confirmed a strong correlation between the
reduction of perceived pain and a decrease in impedance. For each
patient, a pain assessment was taken one week after that patient's
last treatment session; on average the entire group measured 35 mm
on the VAS. Fifteen of these patients had individual VAS
indications of under 10 mm. For several patients, the relief from
pain persisted for months following their last treatment
session.
* * * * *