U.S. patent application number 13/751511 was filed with the patent office on 2013-08-01 for apparatus and method for quick pain suppression.
This patent application is currently assigned to Competitive Technologies, Inc.. The applicant listed for this patent is Competitive Technologies, Inc.. Invention is credited to Giuseppe Marineo.
Application Number | 20130197604 13/751511 |
Document ID | / |
Family ID | 39462177 |
Filed Date | 2013-08-01 |
United States Patent
Application |
20130197604 |
Kind Code |
A1 |
Marineo; Giuseppe |
August 1, 2013 |
APPARATUS AND METHOD FOR QUICK PAIN SUPPRESSION
Abstract
Apparatus and methods for quick acute and chronic pain
suppression, particularly useful and effective towards high-grade
pains and/or pains resistant to other analgesic drugs such as
opiates. One apparatus and method generate synthetic "non-pain"
information strings of great clinical effectiveness, allowing high
reproducibility of the clinical result. Synthesis of the strings
occurs by combining novel geometries of complex waveforms in a
sequence, perceived as "self" and "non-pain" by the CNS.
Inventors: |
Marineo; Giuseppe; (Rome,
IT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Competitive Technologies, Inc.; |
Fairfield |
CT |
US |
|
|
Assignee: |
Competitive Technologies,
Inc.
Fairfield
CT
|
Family ID: |
39462177 |
Appl. No.: |
13/751511 |
Filed: |
January 28, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12080434 |
Apr 2, 2008 |
8380317 |
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13751511 |
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PCT/IT2007/000647 |
Sep 18, 2007 |
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12080434 |
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Current U.S.
Class: |
607/46 |
Current CPC
Class: |
A61N 1/36021 20130101;
A61N 1/36071 20130101; A61N 1/36146 20130101 |
Class at
Publication: |
607/46 |
International
Class: |
A61N 1/36 20060101
A61N001/36 |
Claims
1-20. (canceled)
21. An apparatus for alleviating pain comprising: a controller for
generating electrical signals, wherein the electrical signals are
generated by selecting a sequence of pre-determined waveforms,
selecting a frequency for each waveform of the sequence, setting a
duration for each waveform of the sequence, and selecting an
intercycle pause for the sequence such that the electrical signals
are not monotonous; and at least two electrodes operatively
connected to the controller for delivering the electrical signals
to a patient's body.
22. An apparatus as recited in claim 21, wherein the controller
includes a main module for controlling operation, a synthesizer
module for overseeing the digital/analog conversion of the sequence
of waveforms, and at least one channel output module for carrying
out a further analog processing of the sequence.
23. An apparatus as recited in claim 21, wherein the electrical
signals a delivered on skin of the patient's body so that surface
receptors in polymodal nerve fibers of a nervous system carry the
electrical signals as non-pain information to suppress chronic
and/or neuropathic pain.
24. An apparatus as recited in claim 21, wherein the pre-determined
waveforms are a set of sixteen different waveforms, each different
waveform having a periodic and predetermined pattern over time.
25. An apparatus as recited in claim 21, further comprising a data
storage memory module operatively connected to the controller and
including a first probabilistic criterion and the controller
selects an arrangement of the pre-determined waveforms using the
first probabilistic criterion.
26. An apparatus as recited in claim 25, wherein the first
probabilistic criterion entails a selection of the pre-determined
waveforms depending on a specific probability to create a plurality
of packets, wherein the specific probability varies dynamically for
each new packet generated.
27. An apparatus as recited in claim 25, wherein the first
probabilistic criterion is dynamically modified according to a
first probabilistic filter stored in the data storage means based
on rules stored in the data storage means to vary a selection
probability of each of the pre-determined waveforms.
28. An apparatus as recited in claim 21, wherein the synthesizer
module comprises a microprocessor and a first digital/analog
converter adapted and configured to convert the electrical signals
into an analog signal corresponding to the sequence.
29. An apparatus as recited in claim 28, wherein the said
synthesizer module further comprises a second digital/analog
converter adapted and configured to produce a modulating signal
based on a pre-programmed signal used as reference for the first
digital/analog converter, thereby carrying out an amplitude
modulation of the electrical signals.
30. An apparatus as recited in claim 21, further comprising: a
first circuit operatively connected to the controller for filtering
and amplifying the electrical signals; a second circuit operatively
connected to the controller for feedback-adjusting a current level
of the electrical signals; and a third circuit operatively
connected to the controller for safety electric decoupling.
31. An apparatus as recited in claim 30, further comprising: a
fourth circuit operatively connected to the controller for
amplitude modulation of the electrical signals, the amplitude
modulation being cyclically activated.
32. An apparatus as recited in claim 21, further comprising a
series resistor operatively connected to the controller for
limiting a maximum current delivered to the patient's body so as
not to exceed 9 mA for safety.
33. An apparatus as recited in claim 21, further comprising
circuitry connected to the controller for allowing modification of
stimulus amplitude to adapt the electrical signals to a sensitivity
of a patient.
34. An apparatus as recited in claim 21, wherein the controller
includes a computer.
35. An apparatus as recited in claim 21, wherein the sequence is
selected from sixteen different waveforms grouped into four groups
such that selection of a waveform from within each group is
initially equiprobable but after selection, a first selected
waveform has a zero probability of selection until a different
waveform from the same group is selected, at which time the first
selected waveform probability of selection is restored to 33%.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of and priority to PCT
Patent Application No. PCT/IT2007/000647, filed Sep. 18, 2007,
which is incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention refers to an apparatus and a method
for quick acute and chronic pain suppression, particularly useful
and effective towards high-grade pains and/or pains resistant to
other analgesic drugs such as opiates.
[0004] 2. Background of the Related Art
[0005] Pain therapy by electrostimulation is practiced with
apparatuses normally producing wave trains ranging from 5 to 100
Hz, with variable duty cycle, at times implementing automatic
frequency and amplitude scanning. These apparatuses are generally
referred to as TENS when used in a non-invasive manner with surface
electrodes, or as implanted electric stimulators when they are
invasive. With reference to substantiated scientific literature,
this kind of electroanalgesia works only with some types of pain,
yet almost never or with largely unsatisfactory and unforeseeable
results in high-grade chronic pain, neuropathic pain, pain
non-responsive to morphine and/or derivatives thereof.
[0006] Moreover, these electric stimulations have a heuristic base
of scientific and technological development; in fact, in the
scientific literature, no commonly accepted explanation exists for
the biological mechanisms of the analgesic effect that is produced
in some cases. One of the theories, still erroneously considered as
plausible to date, is that the electric stimulus fosters endorphin
production, and endorphins, in turn, are accountable for the
analgesia. Actually, targeted and published clinical research
experimentally invalidated this explanation attempt, leaving this
method to empiricism. More reliable is the explanation of operation
according to Gate Control theory. Accordingly, these electric
stimulations are deemed to have an inhibiting function on painful
stimulus transmission, by blocking electric-type nerve
conduction.
[0007] Ultimately, though using electronic technologies, the
operation principle does not diverge much from the first attempts
at electroanalgesia, historically ascribable to Hippocrates, who
used torpedo fish to cure gout pains.
[0008] In preceding studies, the problem of oncological pain and
that of high-grade chronic pain non-responsive to protocols have
been specifically dealt with. These studies have led to the
development of an "artificial neuron" able to generate "non-pain"
information strings. The artificial bioinformation, by modulating
suitable electric potentials carried into the nerve network by
surface electrodes, overlaps pain-coding endogenous information,
attaining a powerful analgesic effect.
[0009] Italian Patent No 1324899, to the same Inventor, begins to
introduce the concepts of a so-called "Scrambler Therapy", based on
the concept of synthetic "non-pain" information for therapeutic
purposes. The patent relates to the manufacture of an apparatus
able to generate an "artificial neuron" allowing concrete use of
this theoretical research and the subsequent technological
development in clinical practice. Neuronal synthesis used in
Italian Patent No 1324899 yielded waveform geometries quite similar
to action potentials produced by human nerve cells (see FIG. 1),
organized according to pre-programmed sequences that achieved a
concrete result in terms of analgesic effect.
[0010] However, subsequent clinical testing of the neuronal
synthesis used in Italian Patent No 1324899 exhibited some
limitations, both in the method and in the hardware implementation
of the apparatus, which entailed a less than satisfactory
efficiency from the standpoint of reproducibility of clinical data,
data that was operator-dependent, and in the difficulties
encountered when treating more complex polyneuropathy cases, which
appeared hardly manageable and rapidly recurring. Moreover,
stimulation perception in some patients who were more sensitive,
also due to neuropathic damage, was hardly tolerable. This
compliance problem increased when treating particularly sensitive
zones, such as the face, or specific regions of the body very rich
in nerve terminations.
[0011] Synthesis was carried out by setting a string comprised of n
action potentials of alike geometry, imitating that typical of
nerve cells to which a control algorithm subtracted, in determined
points, variable blocks of individual potentials, in order to
create the required synthetic information in the form of strings.
Such a procedure, initially being of a survey type, was mainly
aimed at replacing the "pain" information with a bland nociception
one; this to be sure to fall within information that the Central
Nervous System (hereinafter, CNS) might easily recognize as "self",
therefore assessing with greater ease the exactness of the
theoretical premise, reducing experimental variability.
[0012] This resulted in an extremely compressed dynamics of the
putative "non-pain" synthetic information, as well as compressed
was the ability to recruit polymodal receptors.
SUMMARY OF THE INVENTION
[0013] Hence, an object of the present technology is to overcome
the drawbacks mentioned above with reference to the known art, by
providing an apparatus for quick pain suppression, including a main
module comprising data storage and processing means, said data
storage including first parameters (V.sub.i) identifying a set of
primitive waveforms (S00-S15), each primitive waveform (S.sub.i)
having a periodic and predetermined pattern over time and second
parameters (T-pack.sub.i, Freq.sub.i, T-slot.sub.i) associable with
each of said primitive waveforms (S.sub.i). The data storage and
processing means are able to process a data set (B.sub.i)
identifying a sequence (S) consisting of one or more of said
primitive waveforms (S.sub.i) in a time sequence, each of the
primitive waveforms of the sequence (S) being processed on the
basis of one or more of said second parameters (T-pack.sub.i,
Freq.sub.i, T-slot.sub.i). The apparatus also includes a
synthesizer module comprising means for generating an electric
output signal corresponding to said sequence (S) and one or more
channel modules (Ch.sub.k) comprising means for applying said
electric output signal to a patient's body.
[0014] Further, another object of the present technology is to
provide a definition of one or more waveforms to be made and used
for generating an electric signal in a therapy for quick pain
suppression.
[0015] Still further, another object of the present invention is a
method for generating an electric signal to be used in a therapy
for quick pain suppression.
[0016] The present technology, by overcoming the mentioned problems
of the known art, entails several evident advantages. One advantage
lies in that the outcome of this inventive process is the
generation of synthetic "non-pain" information strings of great
effectiveness, capable of allowing a high reproducibility of the
clinical outcome.
[0017] Known-art limitations were overcome by restructuring the
geometries of primitive waveforms, in order to construct different
and more complex dynamic "non-pain" information, jointly with the
need to engage a greater number of nerve fibres, especially the
polymodal ones, intrinsically able to carry a wider dynamic of
non-strictly nociceptive information, therefore also able to
establish a greater patient compliance.
[0018] In one embodiment, the method of widening the variability of
"non-pain" synthetic information entails the need to use, for a
dynamic management of the novel and different waveform geometries
(constituting a base comparable to "letters of the alphabet" of the
synthetic information with a wider "non-pain" variability), novel
control algorithms for the definitive assembly into dynamic
strings, i.e., information more complex than the individual
waveforms.
[0019] A further advantage attained is an increase in patient
compliance. With the preceding known-art system, the use of
substitutive information mainly based on bland nociception
synthesis, especially in particularly sensitive persons, created a
certain stress and a state of apprehension for fear of feeling pain
grow or receiving "jolts" during the treatment. Replacement of this
information with other information always perceived as "self" and
"non-pain" by the CNS, instead produced in treated patients
opposite emotional responses, in some cases also described as:
"sensations difficult to describe, but anyhow very pleasant".
[0020] Therefore, the outcome of this inventive process is the
generation of synthetic "non-pain" information strings of great
clinical effectiveness, not merely in immediate analgesia, but also
in medium and long-term effects, and allows high reproducibility of
the result for damage typology, as well as a sensible increase in
the compliance of patients subjected to therapy.
[0021] A further advantage of the present technology is making less
critical the use of the method in clinical practice, thanks to the
increase in the likelihood of recruiting groups of fibres involved
in the carrying of synthetic "non-pain" information, and therefore
to a less critical selection of surface receptors useful to carry
the synthetic "non-pain" information. The studies and testing
carried out, whose results are summarised in the graphs of FIGS.
12A to 12C, illustrate the effectiveness of the subject technology,
which certainly will become the basis of new technologies used for
pain control by means of antagonist synthetic information.
[0022] It should be appreciated that the present technology can be
implemented and utilized in numerous ways, including without
limitation as a process, an apparatus, a system, a device, a method
for applications now known and later developed or a computer
readable medium.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Other advantages, features and the operation modes of the
present invention will be made apparent in the following detailed
description of an embodiment thereof, given by way of example and
not for limitative purposes. Reference will be made to the figures
of the annexed drawings, wherein:
[0024] FIG. 1 shows a typical action potential produced by human
nerve cells;
[0025] FIGS. 2A to 2P are graphs depicting the pattern over time of
the primitive waveforms according to the present invention;
[0026] FIG. 3 is a block diagram of an apparatus according to the
present invention;
[0027] FIG. 4A is a flow chart schematically illustrating a control
algorithm of the synthesis according to the present invention;
[0028] FIG. 4B schematically illustrates the algorithm result, in
terms of sequence of data S and control bytes S;
[0029] FIG. 5 is a circuit diagram of a synthesizer module
according to the present invention;
[0030] FIG. 6 is a block diagram of a channel module according to
the present invention;
[0031] FIG. 7 is a view of a pair of electrodes to be used in the
use of the present invention;
[0032] FIGS. 8A to 8P are graphs representing the pattern over time
of the waveforms as processed and applied to a patient;
[0033] FIGS. 9 to 11 show examples of electrode arrangement on a
patient's body, according to the method of the present invention;
and
[0034] FIGS. 12A to 12C are graphs showing the results of performed
testing.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0035] The present invention overcomes many of the prior art
problems associated with managing pain. The advantages, and other
features of the technology disclosed herein, will become more
readily apparent to those having ordinary skill in the art from the
following detailed description of certain preferred embodiments
taken in conjunction with the drawings which set forth
representative embodiments of the present invention and wherein
like reference numerals identify similar structural elements.
[0036] The present invention is based on the following theoretical
observation. As it is known, the "pain system" is characterized by
a high level of information content, which per se forms its
essence. The data of interest taken into account here is the
central role of control of "pain" information as to the
chemico-structural variations of the pain system on the whole, and
in its varied clinical manifestations.
[0037] Therefore, according to the present technology, it is deemed
possible to control the lower levels of complexity of the pain
system, i.e., the biochemical ones, by manipulating at higher
levels of complexity (the bioelectric ones generated by nerve
cells) the associated "information" variable alone, which in these
levels of emerging properties is easily treatable by coding
electric potentials into synthesis of waveforms having variable
geometry and dynamic assembly structure, with informative
functionality analogous to that peculiar to nerve cells.
[0038] Therefore, the present invention is carried out by
manipulating the endogenous "pain" information, replacing it with a
synthetic, yet recognized as "self" by the body, "non-pain"
one.
[0039] From an informative standpoint, the geometry of the
individual primitive waveforms (see FIGS. 2A to 2P) substantially
represents an alphabet of "letters" that, when dynamically
assembled into strings of variable length and content, constructs
the equivalent of plural synthetic "non-pain" information, which
the nervous system recognizes as "self" once carried therein.
[0040] The synthetic information is able to overmodulate the
endogenous pain information, attaining as a clinical effect the
immediate disappearance of perception of pain; this regardless of
pain intensity, frequency, benign or oncological typology, presence
of neuropathic damage, resistance to opiates or to other forms of
electroanalgesia.
[0041] By precisely selecting the geometry of the primitive
waveforms and applying the waveforms in a specific sequence manner,
excellent results can be accomplished.
[0042] It is also easy to imagine that, in principle, synthesis
options are substantially infinite, as there is no general rule
such waveforms have to meet. Therefore, the selection according to
the present technology was carried out through the several studies
and clinical testing performed therefor.
[0043] Therefore, since these are synthetic waveforms not simply
describable by mathematic models, hereinafter there will be
described a set of primitive waveforms (S00-S15) used on the basis
of respective first parameters V.sub.i identifying them, in
particular of their respective amplitude values, and used just for
the synthesis. Each primitive waveform has a periodic and
predetermined pattern over time. This, in association to a definite
time basis that will be pointed out, allows an exact reconstruction
thereof.
[0044] In the following Table 1 there are reported the amplitude
values, expressed in the hexadecimal system, used for waveform
synthesis.
[0045] According to a preferred embodiment of the present
technology, each individual primitive waveform S.sub.i is
numerically represented by a vector V.sub.i of 64 8-bit values.
TABLE-US-00001 TABLE 1 Prim- itive wave- form vector V.sub.i of
amplitude values (i = 0 . . . 15) S00 B6 FE FE FE FE FE FE FE FE FE
FE FE FE FE FE FE EC DA C8 B6 A4 92 80 00 20 40 60 6E 80 80 80 80
80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80
80 80 80 80 80 80 80 80 80 80 S01 81 B6 FE FE FE FE FE FE FE FE FE
FE FE FE FE FE FE FE FE FE FE FE FA EC DE D0 C2 B4 A6 9A 8E 00 20
40 60 6E 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80
80 80 80 80 80 80 80 80 80 S02 81 AA D4 FE FE FE FE FE FE FE FE FE
FE FE FE FE FE FE FE FE FE FE FE FE FE FE F0 E2 D4 C6 B8 AA 9C 8E
80 00 20 40 60 6E 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80
80 80 80 80 80 80 80 80 S03 81 AA D4 FE FE FE FE FE FE FE FE FE FE
FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE F5 EC E3 DA D1 C8 BF
B6 AD A5 9B 92 80 00 20 40 60 6E 80 80 80 80 80 80 80 80 80 80 80
80 80 80 80 80 80 80 S04 B6 FE FE FE FE FE FE FE FE FE FE FE FE FE
FE FE EC DA C8 B6 A4 92 80 00 10 20 30 40 60 70 80 80 80 80 80 80
80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80
80 80 80 80 80 80 S05 81 B6 FE FE FE FE FE FE FE FE FE FE FE FE FE
FE FE FE FE FE FE FE FA EC DE D0 C2 B4 A6 9A 8E 00 10 20 30 40 60
70 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80
80 80 80 80 80 S06 81 AA D4 FE FE FE FE FE FE FE FE FE FE FE FE FE
FE FE FE FE FE FE FE FE FE FE F0 E2 D4 C6 B8 AA 9C 8E 80 00 10 20
30 40 60 70 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80
80 80 80 80 S07 81 AA D4 FE FE FE FE FE FE FE FE FE FE FE FE FE FE
FE FE FE FE FE FE FE FE FE FE FE F5 EC E3 DA D1 C8 BF B6 AD A5 9B
92 80 00 10 20 30 40 60 70 80 80 80 80 80 80 80 80 80 80 80 80 80
80 80 80 S08 B6 FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE EC DA
C8 B6 A4 92 80 00 04 08 0C 10 16 1C 22 28 2E 34 3A 40 50 60 70 78
80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80
80 80 S09 81 B6 FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE
FE FE FE FA EC DE D0 C2 B4 A6 9A 8E 00 04 08 0C 10 16 1C 22 28 2E
34 3A 40 50 60 70 78 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80
80 S10 81 AA D4 FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE
FE FE FE FE FE FE F0 E2 D4 C6 B8 AA 9C 8E 80 00 04 08 0C 10 16 1C
22 28 2E 34 3A 40 50 60 70 78 80 80 80 80 80 80 80 80 80 80 80 80
S11 81 AA D4 FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE
FE FE FE FE FE FE FE F5 EC E3 DA D1 C8 BF B6 AD A5 9B 92 80 00 04
08 OC 10 16 1C 22 28 2E 34 3A 40 50 60 70 78 80 80 80 80 80 80 S12
B6 FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE EC DA C8 B6 A4 92
89 00 05 09 0E 18 1E 20 22 28 2E 34 3A 40 49 52 5B 64 6D 77 7F 80
80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 80 S13 81
B6 FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FA
EC DE D0 C2 B4 A6 9A 8E 00 05 09 0E 18 1E 20 22 28 2E 34 3A 40 49
52 5B 64 6D 77 7F 80 80 80 80 80 80 80 80 80 80 80 80 80 S14 81 AA
D4 FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE
FE FE F0 E2 D4 C6 B8 AA 9C 8E 80 00 05 09 0E 18 1E 20 22 28 2E 34
3A 40 49 52 5B 64 6D 77 7F 80 80 80 80 80 80 80 80 80 S15 81 AA D4
FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE FE
FE FE FE F5 EC E3 DA D1 C8 BF B6 AD A5 9B 92 80 00 05 09 OE 18 1E
20 22 28 2E 34 3A 40 49 52 5B 64 6D 77 7F 80 80 80
[0046] FIGS. 2A to 2P show the pattern of the waveforms
preferentially selected according to the invention, S00 to S15. It
should also be understood that even forms diverging from the above
ones (for example variations in the amplitude of one or more
samples) could be used for the application of a method such as that
described here.
[0047] The images shown in those figures were obtained with a PC
oscilloscope (Picoscope 3204), having the following technical
features:
TABLE-US-00002 Band 50 MHz Buffer size 256K Basic range of times 5
ns/div to 50 s/div Analog bandwidth 50 MHz Precision 3% Resolution
8 Bit Sampling rate 50 MS/s
[0048] Hereinafter, an apparatus according to the present
technology will be described.
[0049] FIG. 3 shows a block diagram of an apparatus 100 according
to the present technology. Referring to the diagram of FIG. 3, it
is possible to identify a Common Bus 102 to which there are
connected the various apparatus modules that will be detailed.
[0050] In particular, the modules are: a main module "Main" 104 for
management; a synthesizer module "Synt" 106 overseeing the
digital/analog conversion of the sequence of primitive waveforms,
as processed by the Main module 104; one or more channel output
modules "Ch.sub.k" 108 for carrying out a further analog processing
of the signals, prior to the application of the latter to the
patient's body, through electrodes 160 (see FIG. 7) precisely
arranged as will be described hereinafter.
[0051] The Main module 104 provides for the full management of the
treatment and the safety devices for the subject undergoing the
therapy. Moreover, a serial output is provided for any
communications and remote control of the device.
[0052] The hardware and the resident firmware mainly carry out
three functions: a first one of user interfacing, a second one of
controlling information string synthesis, and a third one of
patient's safety.
[0053] At a circuit level, the Main module 104 preferably comprises
data storage 110 and processing means 112, implemented with a first
microprocessor, to which the I/O devices and the bus control flags
interface. Such an architecture is to be deemed as within the reach
of a person skilled in the art.
[0054] The user interface 114 is preferably made by means of an LCD
display 116 and an array of keys 118 for commonly requested
functions. Optionally, remote control via serial interface is
possible. It is understood that other interface typologies are
viable, e.g., a touch screen and the like.
[0055] In addition, the Main module 104, and specifically the
storage 110 and processing means 112, is assigned to controlling
the synthesis of data, data which comprises the above-indicated
parameters V.sub.i and also second parameters T-pack.sub.i,
Freq.sub.i, T-slot.sub.i; associable to each primitive waveform
S.sub.i, whose meaning will be explained in detail.
[0056] Advantageously, the set of primitive waveforms S00-S15 may
be stored on a storage medium, be it internal to the Main module
104, and an integral part thereof (nonvolatile memory modules or
the like) or external thereto and/or removable, like e.g., a CD-ROM
or the like.
[0057] Resident software continually processes the sequence S to be
digitalized, sending on the bus 102 a data set B.sub.i, identifying
said sequence S, required by the synthesizer module 106 in order to
produce, in real time, an electric output signal "Out",
corresponding to the required sequence S.
[0058] In particular, the software residing in the Main module 104
implements a selection algorithm, schematically illustrated in the
flowchart 120 of FIG. 4A.
[0059] For clarity's sake, in FIG. 4B a schematization of the
outcome of the selection algorithm in flowchart 120 of FIG. 4A is
shown. In FIGS. 4A and 4B, the description the following
definitions will be used:
[0060] Packet--Pack: sequence of an individual primitive waveform,
repeated over time. The time duration T-pack.sub.i of a packet
Pack.sub.i is preferably of at least 700 mS, with a preferred upper
limit of about 10 s. However, it is understood that a packet
duration of could also be longer than 10 s, and even equal to the
treatment duration.
[0061] Inter-cycle pause--Slot: pause interval between a packet and
the next one of a time duration (value) T-slot.sub.i preferably
ranging from 0 to 38 mS.
[0062] Frequency--Freq: frequency to be associated to the waveform
of the packet, preferably ranging from about 43 to 52 Hz, values
corresponding to a period ranging from about 23.26 ms to 19.23
ms.
[0063] Therefore, the sequence S will be processed as a composition
of one or more of said primitive waveforms S.sub.i in a time
sequence, each of which will in turn be processed on the basis of
the parameters T-pack.sub.i, Freq.sub.i, T-slot.sub.i which are
calculated according to predetermined modes that will be
illustrated hereinafter.
[0064] The geometry of each individual primitive waveform S.sub.i
described has an intrinsic content of information such as to induce
analgesia.
[0065] In this sense, making a traditional-type TENS which, instead
of using the classic waveforms derived from square, sinusoid,
triangle, continually delivers even only one of the waveforms
S00-S15 described here, would already constitute a remarkable
advance in technology and results.
[0066] However, any processing, described hereinafter, of the basic
information of the individual primitive waveforms, into packets and
therefore more complex information strings, is preferable in order
to optimize the analgesic effect in the most difficult cases, above
all of chronic pain, to which the device 100 is explicitly
destined; i.e., those cases not satisfactorily responding to any
conventional pharmacological and/or surface or implanted
electroanalgesic treatment.
[0067] Yet, before continuing with the description, a short premise
is in order. CNS by its own nature discriminates and processes
information, but in this process it also has the property of
modifying over time the perception of information into ground noise
if the content thereof is monotonous, e.g., always the same for
long time intervals. An explanatory analogy is what happens when
one is in a crowded place, full of people talking. At first, one
will tend to concomitantly discriminate one or more voices present
in the surrounding environment, yet over time perceptive adaptation
will lead to consider the whole as environment noise, i.e., ground
noise, ignoring the associated information content, though the
latter is still present. This situation changes only if background
noise changes briskly, i.e., if in monotony a new element is
introduced which varies the average information content, e.g., a
person suddenly raising his/her voice, a plate falling and
breaking, etc.
[0068] A similar problem is known in the use of traditional TENS,
with its known limitations in efficacy. Over time, initially
responsive patients become resistant and the therapy is no longer
effective.
[0069] Since acknowledged information always has the central role
of controlling CNS discriminating properties, just as for the
analgesic effectiveness in the different pain typologies, it is
beneficial to synthesize different "non-pain" information
sequences, thereby widening the dynamics of the resulting string
and avoiding monotony, so that treatment proves effective. This
principle was experimentally tested in clinical practice, with a
favourable outcome for the object and the ends of the present
technology.
[0070] The strategy of the dynamic construction of information is
processed by the Main module 104, which, by writing control bytes
B.sub.i on the bus, makes it available to the synthesizer module
Synt 106; the latter, by reading the current byte, accordingly
generates the required geometry with the associated properties of
frequency, inter-cycle pause, packet duration.
[0071] Each control byte B.sub.i may contain at least the
information related to an individual packet, and specifically:
[0072] a first four-bit portion to code the primitive waveform
S.sub.i to be used for the current packet Pack.sub.i,
[0073] a second two-bit portion to set the frequency Freq.sub.i
(43, 46, 49, 52 Hz) thereof, and
[0074] a third two-bit portion to set the duration of the
inter-cycle pause T-slot.sub.i (0-38 mS), subsequent to the current
packet Pack.sub.i.
[0075] The time duration T-pack.sub.i of the packet is instead
determined by the time in which the corresponding control byte
B.sub.i is kept unvaried and available on the BUS 102.
[0076] The dynamic construction of the control byte B.sub.i occurs
by following probabilistic criteria, whose reference parameters
have been identified in the fundamental scientific research of the
subject inventor, propaedeutical to the development of the
described.
[0077] The core for processing the probabilities of the control
byte coming out in the composition is a random number generator
slaved to a probabilistic filter that modifies its output in
percent terms.
[0078] Essentially, a pseudo-random number ranging from 1 to 100 is
continuously generated. This number passes through a conditional
filter setting the probability thresholds of the actual user. For
example, when desiring a variable P at each output of the random
generator to have a 40% possibility of being 0 and a 60%
possibility of being 1, a condition such as: "IF random
number<41 then P=0 else P=1" will be used.
[0079] This code carries out the filtering required in order that
the arbitrary probability, which has been defined to modify the
values of variable P starting from a random number, be complied
with.
[0080] This design is explicitly recalled in the following
descriptions, related to the algorithm for control byte
construction, applying one or more of the conditional filters
described hereinafter.
[0081] Selection Probability of Primitive Waveform.
[0082] Referring to FIG. 4A, at step 122, selection of primitive
waveforms S.sub.i is performed on the basis of a first
probabilistic criterion. Though it is understood that such a first
criterion could entail a completely random selection, according to
a preferred embodiment, it is preferable to vary each time the
probability of selection of each of the waveforms, by dynamically
varying a first probabilistic filter used for this purpose.
[0083] In particular, the 16 primitive waveforms are subdivided
into 4 groups, each containing 4 different primitive waveforms.
Initially, the same probability (25%) of coming out is assigned to
each group, and the same probability (25%) of coming out is
assigned to any group-associated primitive waveform.
[0084] When a group is selected, its probability of coming out is
reduced to 10%, that of the immediately subsequent group is
automatically increased to 40%, and that of the remaining groups is
brought back to the 25%, with a circular pattern.
[0085] In practice, selection of group 1 implies setting at 10% its
next probability of coming out, at 40% that of group 2, at 25% that
of groups 3 and 4. Likewise, selection of group 4 implies setting
at 10% its next probability of coming out, at 40% that of group 1,
at 25% that of the remaining ones, etc.
[0086] Another step is the modifying of the probability of
selection, within the selected group, of one of the 4 possible
waveforms, initially equiprobable, within the same group. The
selected waveform, in conjunction with the associated frequency,
brings to 0% its next probability of coming out in the group,
probability that is restored to 33.33% only when another waveform
is selected which belongs to the same group and is associated to
the same frequency, following the same procedure of modifying the
next probability of coming out within the same group.
[0087] In practice, before setting at zero its probability of
coming out in the absence of a general resetting, each waveform has
4 different possibilities of coming out in connection to the 4
possible associated frequencies. Therefore, consecutive coming out
of the same waveform with a different frequency is possible, though
it is a low-probability event, yet the consecutive coming out of
the same waveform with the same frequency will not be possible in
the preferred embodiment.
[0088] It has to be pointed out that the association of the 16
available waveforms to the 4 provided groups follows analytical
criteria associated to experimental validations. One of the
groupings experimentally detected as more effective is the
following one:
[0089] Group 1: S00, S01, S02, S03
[0090] Group 2: S04, S05, S06, S07
[0091] Group 3: S08, S09, S10, S11
[0092] Group 4: S12, S13, S14, S15
[0093] However, it should be deemed valid in any possible
combination thereof and even with repetitions, as anyhow the
resulting analgesic information rate is always present, albeit with
different effectiveness.
[0094] Concerning the further parameters indicated, T-pack.sub.i,
Freq.sub.i, T-slot.sub.i, probabilistic selection rules are still
applied. In particular, parameters are selected from values, or
value ranges, set on the basis of further and respective
probabilistic criteria, which preferably are dynamically modified
by applying further probabilistic filters, in order to vary each
time the selection probability of set starting values.
[0095] Hereinafter there are described probabilistic filters
related to the above-indicated parameters, as preferably used in a
preferred embodiment. Once again, it is understood that said
conditions may be modified, without thereby altering the inventive
concept underlying the present invention.
[0096] Selection Probability of Frequency Associated to Selected
Primitive Waveform
[0097] Still referring to FIG. 4A, at step 124, a primitive
frequency is selected. It is envisaged that the four preferred
frequencies, to be assigned to the selected primitive waveform, be
the following ones:
TABLE-US-00003 43 Hz 15%, 46 Hz 45%, 49 Hz 15%, 52 Hz 25%.
[0098] As mentioned hereto, the selection of one of the frequencies
also affects the subsequent probability of selection of the
waveforms, as described above.
[0099] Selection Probability of Inter-Cycle Pause.
[0100] Still referring to FIG. 4A, at step 128 intercycle pause is
selected. It is noted that step 126 could also occur next. Indeed,
the order of the steps shown and described is merely illustrative
and not meant to be limiting in any way. The overall therapy time
is divided by 4, and differentiated into corresponding phases at
which the selection probability of a duration is modified. The
duration of inter-cycle pauses pause deriving in terms of
probability is the following: [0101] Phase 1: 70%-0 mS, 30%-12 mS
[0102] Phase 2: 70%-12 mS, 30%-25 mS [0103] Phase 3: 70%-25 mS,
30%-38 mS [0104] Phase 4: 70%-38 mS, 30%-0 mS
[0105] Time Duration Probability for a Packet.
[0106] Still referring to FIG. 4A, at step 126 packet duration is
set. In this case, randomization is simpler and sets the time
duration of a packet from a minimum of 0.7 seconds.
[0107] The synthesizer module "Synt" 106 comprises first of all
means for generating an output electric signal "Out", corresponding
to the sequence S as programmed by the Main module 104.
[0108] Synthesis preferably occurs by 8-bit digital/analog
conversion, controlled by resident firmware.
[0109] Referring to the diagram of FIG. 5, there may be observed
the use of two digital/analog converters (hereinafter DAC) 140, 142
slaved to a second microprocessor "Micro" of the processor 112 of
the main module 104. The second Micro of the processor 112 is
dedicated to synthesis, e.g., a synthesis microprocessor.
[0110] The synthesis microprocessor continually reads on the bus
the current control byte B.sub.i processed and provided by the Main
module 104, and, on the basis of the information contained therein,
provides on the input port of the DAC2 142, the amplitude values
(read by the corresponding vector S00-S15) to be converted for the
synthesis of the selected waveform. Of course, each individual
sample is timed according to the selected frequency Freq.sub.i.
[0111] The DAC2 output, typically stepped, is preferably integrated
by a low-pass filter made with an output operational amplifier,
which also works as buffer. In the embodiment described, filter
cutoff (frequency) is calculated at about 1592 Hz, and its slope is
of 6 db/oct. At the output, the Out signal is made available on the
bus 102 for the channel modules 108 connected thereto.
[0112] Preferably, the reference input of the converter DAC2 142,
is not connected to a constant-value voltage source as usual, but
supplied by the other DAC1 140.
[0113] The input port of the converter DAC1 140 is supplied with
pre-programmed data, in order to carry out a rapid equalizing of
the response of current feedback circuits present on the subsequent
channel module, precision rectifier included, depending on the
different waveforms synthesized at the moment.
[0114] Thus, at the beginning of each change of waveform, a first
amplitude modulation is obtained of each packet due both to digital
equalization and to the response time of the precision rectifier,
whose output is continuously compared with the output level
manually set to keep the output level constant even if the load
modifies its impedance in the therapy time.
[0115] Modulation is useful to enhance the noise figure, in terms
of amplitude non-linearity, present in long sequences of action
potentials typical of a nerve cell subjected to prolonged stimuli.
Overall dynamics of the output variation, considering 100% as
maximum amplitude, can drop to 67% of the upper limit.
[0116] As mentioned, the analog signal thus produced is made
available on the bus 102 for all channel modules Ch.sub.k 108
provided and connected thereto.
[0117] A channel module Ch.sub.k 108 may be made according to
different architectures, from that envisaging merely the use of a
microprocessor to that envisaging a wide use of operational
amplifiers and wired logic. Alternatively, though requiring more
componentry and higher circuit complexity, is usually intrinsically
more stable and reliable, as well as less noisy on the level of
processing and analog output.
[0118] These requirements are fundamental to the safety of a
patient subjected to the treatment, and for this reason preferable
with respect to other industrial demands.
[0119] The block diagram of FIG. 6 schematically shows the
structure of a general channel module Ch.sub.k 108 that should
perform the required functions, substantially of filtering and
amplifying the output signal provided by the Synt module 106, of
adjusting in feedback the current level of the output signal,
needed also to compensate for pressure variations on the electrodes
160, perspiration effects, alarm in case of cut-off or
short-circuiting of the external wiring on the patient.
[0120] It is deemed that the implementation of a channel module
108, once its functionalities have been described and the needs to
which it is subject, entails no specific technical problems and are
within the skill of a person in this field.
[0121] Referring to FIG. 7, two electrodes 160 are shown. In a
preferred embodiment, single-use 5-cm electrodes 160 of ECG-type or
of equivalent surface may be used.
[0122] Output signal amplitude control depends on a level, manually
set by the user with a mere potentiometer, which, compared to a
small fraction of the output signal, representative of the current
actually delivered on the user, drives a digital potentiometer.
This comparator-driven digital potentiometer sets the actual output
current, but also performs the task of compensating for differences
between the manually set value of current intensity and deviations
of the effective value over time, due to electrode gel drying, skin
dehydration, pressure variations on the electrode 160, and the
like.
[0123] Current feedback is also monitored with a threshold
comparator to ascertain whether standard operating limits have been
exceeded, an event activating safety protections with cut-off of
on-patient output, restorable only manually upon removing the
causes of intervention of the protection.
[0124] The signal thus controlled is sent to a low-pass filter cut
off at 159 Hz with a 20 slope of 6 dB/oct., and voltage-amplified
to drive a class-B power amplifier, preferably comprised of two
complementary Darlington pairs. The power stage has as load, a
transformer/separator that works as a voltage raiser (1/39 ratio)
and decouples the patient from the remainder of the circuitry,
increasing the insulation level and the safety to any power-supply
failures. Maximum voltage deliverable by the amplifier is
preferably of 95V RMS on a >1 Kohm load. Maximum current
delivered to the patient is limited by a series resistor at the
output and by a varistor, preferably so as not to exceed 9 mA. Also
the current output fraction feedbacked for the above-described
adjustment purposes is preferably decoupled through a transformer,
for the same user's safety reasons.
[0125] A further channel-associated function is that of a
programmed amplitude desynchronization, necessary when more
channels are used concomitantly in order to diversify the
perception thereof by the CNS, as well as supplementing noise
simulation.
[0126] This desynchronization is based on a second AM-type
modulation; but, unlike that operated in the Synt module 106, which
works in a synchronic and parallel manner on all channels, this
second amplitude modulation is of local type, and is cyclically
active in sequence only on one channel at a time. The rate of this
second amplitude modulation is equal to about 8% of the reference
value of voltage inputted to the manual-adjustment potentiometer,
which is automatically affected thereby. Maximum duration of the
modulation, cyclically repeated in sequence on each of the n
channels, is of about 40 mS.
[0127] The channel module 108 may be repeated to increase the
number of outputs available for the user. Therefore, it is possible
to provide the use of one or more channel modules 108 (preferably 5
or more), all exactly alike and driven as described above.
[0128] Hence, for "non-pain" information strings, the system 100
provides a time sequence of packets and pauses with the modulation
characteristics described above.
[0129] The waveforms denoted by C00 to C15, graphically illustrated
in FIGS. 8A to 8P, refer to the real output on the patient.
[0130] For clarity's sake, the waveforms reported in FIGS. 8A to 8P
are devoid of the modulations required to simulate the noise of the
endogenous nerve conduction line, modulations anyhow not
substantially varying the geometry thereof.
[0131] Moreover, by means of suitable digital signaling incoming
from the channel modules 108, the Main module 104 can also check
correct operativeness and any presence of critical failures.
[0132] Patient safety is ensured by three levels of simultaneous
circuit responses in case of operation anomalies, operative errors
and failures.
[0133] A first level of response is of software type, carried out
through the monitoring of suitable signaling read by the Main
module 104. A second level of protection is internal to the channel
module 108, and is based on responses directly slaved to wired
logic, therefore not sensitive to any program execution blocking. A
last level of protection is of passive type and ensures, also in
case of serious failures, non-exceeding of limit currents for the
patient, thanks to the output resistor network, a branch of which
is variable by means of the varistor.
[0134] From a therapeutic standpoint, the present technology is
indicated in all cases of pain such as severe-grade, chronic,
drug-resistant, resistant to opiates, TENS, implanted stimulators,
of benign and oncological type.
[0135] In the envisaged conditions of correct use, detailed
hereinafter, analgesia is very rapid; upon starting the treatment,
only a few seconds are needed to attain complete disappearance of
the perception of pain, even for maximum intensities and no
response to opiates. A prolonged use increases treatment
effectiveness, with a gradual raise in the pain threshold outside
of the same treatment and an increase in the analgesic effect
duration measured in hours.
[0136] During testing, no undesired effects were found under
envisaged use conditions.
[0137] An apparatus according to the present technology, in order
to apply the analgesic therapeutic method, may be used in a
hospital context as well as in an outpatient care unit one, even in
an autonomously patient-managed way, but of course always under a
doctor's supervision.
[0138] For many conditions, optimal treatment time, ensuring
immediate effectiveness as well as analgesia duration, is 30-45
minutes.
[0139] In case of oncological pain, save specific reasons, patient
treatment should be performed when required.
[0140] It is advisable to reduce with a scaling down mode and, as
far as possible, the analgesic support of pharmacological type,
when used. It has been tested that a complete suspension of
analgesic drugs is viable in the majority of cases affected by very
severe-grade or untreatable oncological pain, whereas in other
cases, it is possible to greatly reduce the dosage of opiates, or
those can be replaced by other less invasive drugs. This precaution
is required not only to optimize the effects of the treatment, but
also to improve the patient's quality of life, a main aim of
palliative care.
[0141] In the case of mild pain, the treatment should envisage
(optionally repeatable) cycles consisting of 10 treatment sessions
with a 5/week frequency. When possible, the sessions may be
consecutively performed when required.
[0142] It is advisable to reduce with a scaling down mode and, as
far as possible, the analgesic support of pharmacological type,
when used. A special case is that of patients using
anticonvulsants. In this case, responses are usually slower and
less stable over time. The reduction in efficacy is likely due to
depression of cerebral bioelectric activity induced by the
anticonvulsant drug, a likely antagonist of the active principle of
the method. Anticonvulsant scaling down, especially when too brisk,
can cause rebound effects. Optimal adjuvant drugs, if required,
generally belong to FANS or the paracetamol category.
i) Opiate use does not reduce effectiveness during treatment; yet,
if not eliminated during the therapy cycle, opiates can prevent a
favourable upward remodelling of the pain threshold, and produce
less stable responses over time at the end of the cycle.
[0143] The therapy subject-matter of the present technology
constitutes an extraordinarily effective pain control system as
long as it is used correctly, following the rules illustrated
hereinafter. It has been experimentally observed that in the
near-totality of cases lacking a satisfactory response under
treatment, this was exclusively due to an erroneous on-skin
deployment of the electrodes 160, or to a faulty assembly thereof.
Upon removing the faults, effectiveness was restored.
[0144] For a good effectiveness, it is preferable to use single-use
5-cm electrodes 160 of ECG-type or of equivalent surface.
Electrodes that are too small can cause rashes, and electrodes that
are too big can engage more nerve ends than required. If the
surface to be treated is wide, plural channels can be used.
[0145] Each single-use electrode 160, even if pretreated, should
preferably be covered with conductive gel on the spongy surface,
using greater amounts if the skin is very dry.
[0146] Body portions where the electrodes 160 are to be positioned
should not be cleaned with alcohol or other dehydrating substances
and ought to be well-dried to allow correct electrode 160 adhesion.
A bad contact, beside making the treatment less effective, may
cause bothersome rashes.
[0147] Lastly, it is certainly preferable not to position the
electrodes 160 on irritated or wound zones or on biological fluids
and, as a general rule, to connect wires on the electrodes 160 only
after having well positioned the latter.
[0148] Save from specific neurological damages, the electrodes 160
are to be arranged "immediately beside" the painful area, setting
them vertical with respect thereto when possible, and anyhow
preferably not positioning the electrodes 160 inside the painful
area. FIG. 9 shows two examples of positioning of a pair of
electrodes 160 on a schematic person 162, where the electrodes 160
are positioned about a painful area 164.
[0149] Imagining a straight line passing through the two points
represented by the electrodes 160, the same should approximately
pass at the center of the area 164 of maximum pain. When required,
plural channels 108 (e.g., electrodes 160) can cover very wide
painful areas 164, observing the electrical phases, which are
identifiable e.g., by a conventional polarity marked, for instance,
by a different colour of the electrodes 160 (e.g., red and black)
or otherwise (+/-, etc.). Therefore, in general, all electrodes 160
of a same kind should be positioned on a same side. For
simplicity's sake, in the figures electrodes 160 are conventionally
identified by symbols "+" and "-".
[0150] Hence, if plural channels 108 are used, all vertical
positionings should have at the top and bottom the electrodes 160
of the same type of each channel 108. The same for horizontal
positionings, which for each channel 108 should have electrodes 160
of the same type both on the right and the left, under pain of loss
of effectiveness.
[0151] Moreover, by following the guidelines above, it is possible
to perform mixed horizontal and vertical positionings, as
illustrated in the representations of FIG. 10. Other configurations
can also be effective.
[0152] In fact, at times finding the right arrangement of the
electrodes 160 can be difficult owing to innervation modifications
due to neuropathy, traumas, surgery, or other
chronicization-induced modifications of the pain system. In this
case, it is necessary to proceed by redundancy, and by subsequent
attempts, taking into account that it can be immediately understood
when a positioning is correct, as pain immediately disappears in a
correctly treated zone. By using such feedback, it is possible to
solve even the most complex situations thanks to the immediate
confirmation on the pain symptom.
[0153] In some cases, difficulties may be found in identifying
pain-free zones useful for the treatment. In these difficult
situations, advanced positioning strategies may be used, which
usually solve the problem. A first strategy, especially useful in
facial pain, is that of using contralateral pathways. Generally, in
a case of lack of response, it is possible to use an homolateral
positioning for one of the two electrodes 160 of the channel 108,
and a contralateral one for the second coupled electrode 160.
[0154] Another type of positioning often solving difficult
situations in a very simple manner, is the X-crossed one, in
conjunction, when required, to the traditional horizontal/vertical
positioning using the other free channels 108. The X-crossed
positioning is illustrated in the representations of FIG. 11.
[0155] Of course, it is understood that, beyond the exemplary
illustrations shown, all described positioning types may validly be
applied to any body area.
[0156] It should be borne in mind that the sign of a correct
treatment is only the disappearance of pain in the treated areas.
For this reason, it is not possible to treat pain prior to its
appearance.
[0157] Moreover, in the case of pains appearing only in certain
positions, it is preferable to ensure that the positioning and the
checking of its effectiveness always occur in conditions in which
pain is present, otherwise the therapy cannot be deemed as
certainly effective. Once certain of the correct positioning, the
patient could take on the positions he/she prefers for getting on
with the treatment.
[0158] In addition, in difficult cases, it is preferable to always
test one channel at a time, in sequence, by positioning one pair of
electrodes 160 at a time and making sure of its analgesic
effectiveness. If the overall time of the entire treatment has
greatly reduced that of residual therapy, it suffices to set to
zero the levels of each channel 108 without modifying the
positioning any more, then stop the therapy with the appropriate
controls, and restart the therapy to correctly perform an entire
treatment.
[0159] In most applications, beneficial and positive effects are
found already after a very short treatment, almost instantly.
However, a treatment of at least 30 min. is preferable. In cases of
very intense pain, typically oncological, the optimal value is to
be brought preferably to 45 min.
[0160] The treatment starts automatically when the level of any one
of the channels 108 rises, and automatically stops once the preset
time (modifiable by setup if necessary) expires.
[0161] The treatment is completely automated and requires no
individual setting of wave parameters, like, e.g., frequency, duty
cycle, scanning, etc., also because irrelevant in the active
principles used. The sole manual regulation required is that of the
stimulus amplitude, to adapt it to the patient's individual
sensitivity.
[0162] For this purpose, channel amplitudes should preferably be
regulated to the limit of the individual tolerability threshold
that the patient under treatment subjectively feels.
[0163] Preferably, levels should initially be regulated during the
first instants of treatment, preferably within the first minute,
and adjusted once the first minute is expired, when the apparatus
is in a steady state, and thereafter whenever the stimulus is not
correctly sensed anymore on both electrodes 160 of each channel 108
involved.
[0164] If at treatment start, the signal is sensed only on one of
the two electrodes 160 of each channel 108, it is necessary to stop
the treatment and modify the positioning of the electrodes 160.
[0165] In muscle pain, for improved effectiveness, at times it may
be preferable that, beside what is expressed in (generally
sufficing) indications on positioning, when certain of a correct
positioning current flow be sensed between electrode pairs 160 of
the same channel 108. If nevertheless the response is not good,
then it is preferable to use plural channels 108 for the same
area.
[0166] In order to prevent rebound effects during or after the
therapy, it is preferable to always make sure that the patient does
not report, in correspondence to one or more electrodes 160, a
painful and/or extremely unpleasant sensation, expression of a
residual recruiting of fibers in connection with the painful area.
This sensation is easy to recognize, as generally a synthesis of
"non-pain" information (i.e., the desired one) is optimally
tolerated, and the sensation associated thereto is often defined as
pleasant. In this case, the electrodes 160 are to be repositioned
slightly farther from the selected spot, until eliminating the
problem and obtaining effective analgesia. Noncompliance with this
indication may result in undesired rebound effects during or after
the treatment.
[0167] A further relevant check to understand whether the
positioning is correct under an electric and functional standpoint,
is that of asking the patient under treatment, after activation of
each channel, if perceived pain sensation varies in that sector. In
fact, regardless of initial pain intensity, which may also be very
high, the answer should always be negative (i.e., no pain
perception=optimal positioning) already after just a few seconds
from the correct adjustment of the stimulus intensity.
[0168] If, upon complete activation of all channels 108, the
patient still reports pain, coverage is not complete and the
therapy will yield effects significantly lower than what can be
done. Less than complete analgesia depends on a mismatching of
involved innervations, or by a very wide and incompletely treated
area 164. In the first case, the electrodes 160 should be better
positioned, as explained in the various positioning strategies. In
the second case, other channels 108 should be used, as explained
above.
[0169] If positioning cannot be modified and after some minutes of
treatment--preferably after about 5 min--perception of pain
persists, even though dimmed, the result will not be good. During
treatment there should always be a decrease in the perception of
pain, even when the latter is of an extremely high degree.
[0170] If pain--even though not present during the
application--recurs (even in a dimmed form) at the end of the
treatment, or reappears a few minutes later, application has to be
repeated making sure that all of the above-described steps have
been complied with.
[0171] For completeness' sake in the description, though by way of
example and without limitation, some results of tests performed are
reported in the graphs of FIGS. 12A to 12C.
[0172] Referring to FIGS. 12A to 12C, the data relates only to
chronic pain non-responsive to other protocol therapies including
opiates, TENS, implanted electroanalgesia. Pain intensities were
measured on a VAS scale from 0 (e.g., no pain) to 10 (e.g.,
unbearable pain), and refer to a treatment cycle consisting of 10
applications. From an analysis of said data, it could easily be
assessed how the latter provide clear evidence of treatment
effectiveness.
[0173] The present invention has been hereto described with
reference to a preferred embodiment thereof. It is understood that
other embodiments might exist, all falling within the concept of
the present invention, and all comprised within the protective
scope of the claims hereinafter.
* * * * *