Apparatus and method for micro-electric medical stimulation of cells

36 Pages·2013·2.23 MB·English

United States Patent [19] [11] Patent Number: 4,738,250
Fulkerson et a1. [45] Date of Patent: Apr. 19, 1988
[54] APPARATUS AND METHOD FOR Journal of Investigative Dermatology, vol. 81, pp.
MICRO-ELECTRIC MEDICAL 144-148, 1983.
STIMULATION OF CELLS OF LIVING Bok, Lee, “Chronic Ulcers of the Skin,” published by
ANIMAL TISSUE McGraw-Hill Book Company, 1985.
Cheng, Ngok, M. D., “The Effects of Electric Current
[75] Inventors: Melvin A. Fulkerson, Burnsville; or ATP Generation, Protein Synthesis and Membrane
Wyman E. Jacobson, Minnetonka; Transport in Rat Skin,” Clinical Orthopedics, vol. 171,
Joseph P. Tretter, Minneapolis; John pp. 264-272.
Van Dierendonck, Robinsdale, all of Konikoff, J. J., “Electrical Promotion of Soft Tissue
Minn. Repairs,” Annals of Biomedical Engineering, vol. 4, pp.
l-5, 1976.
[73] Assignee: Mems Technology, Incorporated,
Mannheimer & Lampe, “Clinical Transcutaneous Elec
Minneapolis, Minn.
trical Nerve Stimulation,” published by F. A. Davis
Company of Philadelphia, Pa., 1984.
[21] Appl. No.: 782,427
Mitchell, Peter, D. Ph.D., “Chemiosmotic Coupling in
[22] Filed: on. 1, 1985 Oxidative and Photosynthetic Phosphorylation,” Bio
logical Review, vol. 41, pp. 445-502, 1966.
[51] lint. (31.4 ............................................. .. A61N 1/36 Mitchell, Peter D. Ph.D., “Vectorial Chemistry and the
[52] US. Cl. ........................................... .. 128/421 Molecular Mechanics of Chemiosmotic Coupling:
[58] Field of Search ............. .. 128/419 R, 429 R, 422, Power Transmission by Proticity,” presented at the
128/423 R Ninth CIBA Medal Lecture and published in Biochemi
cal Society Transactions, vol. 4, pp. 400-430, 1976.
[56] References Cited Wolcott, L. E. et al., “Accelerated Healing of Skin
Ulcers by Electrotherapy: Preliminary Clinical Re
U.S. PATENT DOCUMENTS
sults,” Southern Medical Journal, vol. 62, pp. 795-801,
3,645,267 2/1972 Hagfors 128/421 Jul. 1969.
3,648,708 3/1972 Haeri' ...... .. 128/422
3,718,132 2/1973 Holt et a1. 128/1 C Primary Examiner-William E. Kamm
Attorney, Agent, or Firm-Kinney & Lange
4,088,141 5/1978 Niemi . . . . . . . . . . . . . . . . .. 128/421
4,102,348 7/1978 Hihara et a1. ......... .. 128/422
[57] ABSTRACT
4,208,008 6/1980 Smith ............. .. 128/419 PG
4,255,790 3/1981 l-londeyhen ............... .. 128/421 A medical electrical apparatus impresses a bipolar, low
4,408,608 10/1983 Daly et a1. ..... .. 128/421 frequency voltage wave form through spaced-apart
4,456,012 6/1984 Lattin ................. .. 128/420 R
electrodes, across a damaged area of living animal tissue
4,520,825 6/ 1985 Thompson et a1. ........... .. 128/422
to cause a low, bipolar, current to ?ow through the
4,582,063 4/1986 Mickiewicz et a1. ............. .. 128/421
damaged area to increase the metabolic activity of via
FOREIGN PATENT DOCUMENTS ble cells in that area and hence to accelerate healing.
The current ?ow is monitored and used to control the
1422845 1/1976 United Kingdom .
1535413 12/1978 United Kingdom . magnitude of the voltage wave to cause the magnitude
1575322 9/1980 United Kingdom . of current flow to be within the desired parameters. The
1587665 4/1981 United Kingdom. frequency, wave form and voltage of the impressed
voltage wave and the current ?ow are all below a level
OTHER PUBLICATIONS
which can damage typical living cells.
Alverez, Oscar M., “The Healing of Super?cial Skin
Wounds is Stimulated by External Electrical Current,” 33 Claims, 3 Drawing Sheets
MS» Patent Apr.19,1988 ‘ Sheet 1 m3 4,738,250
CROSS/N6 P4 7'7'ER/V
MS“ Patent Apr.19,1988 Sheet 2 of3 4,738,250

4,738,250
l 2
Dr. Cheng and his colleagues reported some of the
APPARATUS AND METHOD FOR biochemical effects that occur in skin tissue of rats dur
MICRO-ELECTRIC MEDICAL STIMULATION OF ing in vitro stimulation with an electric current. Their
CELLS OF LIVING ANIMAL TISSUE method included the application of a direct electrical
current to samples of tissue using currents that varied
BACKGROUND OF THE INVENTION from one to 30,000 microamperes, usually for two to
1. Field of the Invention four hours at a constant temperature of 37° C. Separate
A portion of the disclosure of this patent document strips of living rat skin were exposed for 2 hours to 10,
contains material which is subject to copyright protec 50 , 100, 500, 1000 and 5000 microamperes direct cur
tion. The copyright owner has no objection to the fac rent. These were then analyzed for ATP levels and
simile reproduction by anyone of the patent document compared with untreated (control) tissues. Their results
or the patent disclosure, as it appears in the U8. Patent indicated a ?ve fold increase in ATP in tissue stimulated
and Trademark Office patent files or records, but other with 500 microamperes direct current.
wise reserves all copyright rights whatsoever. Using one to 30,000 microamperes direct current to
This invention has relation to the use of an electrical additional strips of rat tissue optimum incorporation of
treatment signal adapted for application to living animal glycine into amino-acids, and subsequent synthesis of
tissue, including human tissue, to thereby induce elec cell protein, occurred also at about 500 microamperes.
tric current flow through cells of that tissue for the Both ATP and protein synthesis fell off in a linear man
purpose of increasing the metabolic activity of the cells, ner for tissue stimulated with 1000 to 5000 microam
20
and for the purpose of preventing further damage to peres. At 5000 to 30,000 microamperes, protein synthe
cells in an area where cells have been initially damaged. sis did not occur, which ?ndings suggested severe and
2. Description of the Prior Art /or lethal damage to the cells.
A chemiosmotic hypothesis has been promulgated by Oscar M. Alvarez, Ph.D. and his colleagues pub
Peter D. Mitchell, Ph.D. Although Dr. Mitchell pub lished a paper entitled: “The Healing of Super?cial Skin
lished a large number of papers in the scienti?c litera Wounds is Stimulated by External Electrical Current.”
ture, an elucidation of this hypothesis, his life’s work, Journal of Investigative Dermatology, 1983; Vol. 81, Pgs.
was presented by him in THE NINTH CIBA MEDAL 144-148. Reported in this paper were the effects of
LECTURE and was published as follows: “Vectorial direct electric current supplied by an energized silver
Chemistry and the Molecular Mechanics of Chemios coated electrode on dermal and epidermal wound heal
motic Coupling: Power Transmission by Proticity.” ing. Eleven young “Yorkshire” pigs were wounded,
Biochemical Society Transactions, 1976, Vol. 4: Pgs. and a direct current was delivered by a silver-coated
400-430. To a substantial extent, this paper is an expla electrode directly over each wound through a wet
nation of, an expansion of, and an updating of a paper dressing with the return electrode situated on another
published by him in 1966 entitled “Chemiosmotic Cou portion of the pig’s body. A self-contained, battery
35
pling in Oxidative and Photosynthetic Phosphoryla operated generator was a source of “constant curren .”
tion.” Biological Review (1966), Vol. 41, Pgs. 445-502. The current was applied as steady state direct current
This hypothesis has now been widely accepted, and for 24 hours at a time over a seven day term. During
in 1976, Dr. Mitchell received the Nobel Prize for his each 24 hour period, “the current intensity decreased
work. The hypothesis was based on four fundamental linearly from 300 microamperes upon initial connection
40
postulates, as to the structural and functional systems to 50 microamperes at the end of a 24 hour treatment
involved in chemical and osmotic forces and by which period.” A large increase in “labeled collagen” was
proton-translocating mechanisms and proton-linked noticed but not until four and ?ve days after wounding.
porter systems operate for cellular metabolism, through Other work in the prior art is discussed in each of the
a topologically-closed insulating membrane, called the foregoing papers, and is listed in the bibliography of
45
coupling membrane. each of these four papers.
By translocating protons, a protonic potential differ A paper by J. J. Konikoff entitled: “Electrical Pro
ential is generated across the insulating membrane. This motion of Soft Tissue Repairs”; Annals of Biomedical
potential difference is quite similar to an electrical po Engineering, Vol. 4, Pgs. l-5 (1976) reported on the
tential difference. 50 tensile strength of excised skin/incisions in rabbits that
The chemiosmotic mechanism at the level of the cell had been cut, and subjected to a 20 microampere cur
membrane has sometimes been referred to as “the rent flow through the incisions for seven days. This
Mitchell pump”, but not so designated by Dr. Mitchell. current flow was direct and applied, apparently, with
Following the teachings of Dr. Mitchell, others have out change of direction for the entire seven day test.
investigated the setting up of an electrical potential Favorable results were obtained as to the strength of the
difference across areas of damaged epidermal and der treated skin/incisions compared to the untreated (con
mal tissue to study the effects of the flow of electrical trol) incisions.
currents through such tissue on the stimulation of meta Other related papers, apparently also dealing with
bolic activity. This includes the stimulation of the gen direct current applied over extended time period in
eration of adenosine triphosphate (ATP), protein syn 60 clude the following: Wolcott, L. E. et al “Accelerated
thesis, an accelerated cell membrane transport system, Healing of Skin Ulcers by Electrotherapy: Preliminary
' and an increase in the production of collagen. Clinical Results”, Southern Medical Journal, Vol. 62,
Ngok Cheng, MD. and his associates investigated Pgs. 795-801 and bibliography cited therein.
some of these effects and published a paper entitled This paper by Wolcott et a1, after summarizing the
“The Effects of Electric Current on ATP Generation, 65 problems faced in connection with bedsores or decubi
Protein Synthesis and Membrane Transport in Rat tus ulcers and other ischemic skin ulcers, goes on to
Skin.” Clinical Orthopedics 1982; Vol. 171, Pgs. characterize the state of the art prior to the present
264-272. invention quite accurately as follows: “Historically,
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3 4
remedies have been distinguished by their ingenuity, cause further damage by cell membrane disruption; and
variety and rather uniform ineffectiveness.” this reduction, done in accordance with the teachings of
The literature relating to transcutaneous electrical the invention, tends to reduce or eliminate this continu
nerve stimulation (TENS) and related to chronic ulcers ing damage without the current flow itself damaging
of the skin has been consulted for possible pertinence to the cells or otherwise insulting the living tissue being
the present invention, and nothing pertinent has been treated.
located. For example, a book entitled: “Clinical Trans— The electrical medical treatment apparatus and in
cutaneous Electrical Nerve Stimulation” by Mann strument of the invention can include a source of direct
heimer and Lampe, has been published by F. A. Davis electrical energy of predetermined voltage. A pair of I
Company of Philadelphia, @1984. It shows the present output terminals are connected to a pair of electrodes
state of the art in the TENS ?eld to be the use of spiked which are adapted to be placed in contact with healthy
waveform electrical energy “bursts” of suf?cient mag tissue opposite one another across damaged tissue, for
nitude and duration to cause muscle twitching and con example; and means is provided for generating from the
tractions. The currents involved are several orders of energy source a voltage wave of predetermined shape
magnitude greater than the currents utilized in the pres 15 and magnitude and impressing it across the output ter
ent invention. minals. The power is held below that at which a cell to
A book “Chronic Ulcers of the Skin” by Y. Lee Bok, be treated can be damaged, and the wave form of the
published by McGraw-Hill Book Company, @1985, voltage wave is such that it and the resulting current
does not even refer to electrical stimulation. Dr. Bok is How will not damage or otherwise insult living tissue
a recognized authority in his ?eld. 20 when impressed across that tissue.
No reference in either book was found which ap To accomplish its purposes, the instrument includes a
peared pertinent to the present invention. means for producing a periodic electrical treatment
A computerized search of the literature relating to signal at a desired treatment signal frequency for a de
this invention has been made; but turned up nothing any sired treatment signal time period. The treatment signal
more pertinent than the prior art discussed above. 25 is characterized by ?rst and second electrical parame
As is evident from the above references, medical ters. The instrument also includes means for receiving
techniques for treating soft living animal tissue through information representative of a selected value of the
the application of electrical energy have only recently ?rst electrical parameter of the treatment signal; means
.vgbeen studied. All of the studies to date appear to use a for monitoring the ?rst electrical parameter of the treat
tsunidirectional current flow. There are, however, detri 30 ment signal; and means responsive to the means for
.~,;mental side effects associated with this technique. Gal receiving information and the means for monitoring the
_,.vanic effects associated with unidirectional current ?rst electrical parameter for causing the second param
.,,flow can, for example, cause cell damage and loss of eter of the treatment signal to increase during each
...tissue integrity. treatment signal time period until the ?rst parameter of
There is clearly a continuing need for improved med 35 the treatment signal attains the selected value, and for
.,_ical techniques for treating such tissue. Electrical tech maintaining the ?rst parameter of the treatment signal at
niques appear to hold great promise. Improvements to the selected value for a remainder of such preselected
known techniques which signi?cantly increase treat treatment signal time period.
ment results would be especially desirable. Such tech In the form of the invention as shown, the ?rst electri
niques should employ current flows which do not have 40 cal parameter is the current of the treatment signal, and
‘jother adverse effects on living animal (including hu the means for producing the treatment signal causes the
(man) tissues, the cells which make up such tissues, or second electrical parameter to be the voltage of the
other biologic systems. To be avoided are current ?ows treatment signal. Without limiting the general coverage
causing stress-electricity (piezoelectricity), excessive of the concept involved, the means for producing the
heat (pyroelectricity), electrical polarization, electrical 45 treatment signal, in the form of the invention as shown,
double layering, or electrophoresis (?eld differential). can cause the magnitude of the current of the treatment
The instrument used to implement these techniques signal to be within a range of about 20 to 900 microam
must, of course, be safe to use. The instrument should peres; and the means for producing the treatment signal
also be easy for clinicians to operate. causes the magnitude of the voltage of the treatment
The inventors and those in privity with them are now signal to be within a range of from zero to 30 volts.
aware of no prior art which is closer than that set out The means for producing the treatment signal pro
above; and are aware of no prior art which negates the duces a bipolar treatment signal having a treatment
patentability of the claims made herein. signal frequency to be within a range of about 0.1 to 15
Hz.
SUMMARY OF THE INVENTION
In one form of the invention, the means for producing
The electrical medical instrument of the invention is a treatment signal causes a treatment activation period
for increasing metabolic activity of desired cells of liv to be within a range of about 20 seconds to about
ing tissue by producing an electrical treatment signal twenty minutes.
adapted for application to the tissue to thereby induce In a ?rst embodiment of the invention, the means for
electrical current ?ow through the cells to be treated. 60 causing the second parameter of the treatment signal to
This increase in metabolic activity results in at least increase causes the second parameter of the treatment
the following positive bene?ts: accelerated production signal to increase linearly during each treatment signal
of adenosine triphosphate (ATP), increased synthesis of time period until the ?rst parameter of the treatment
cell protein, improved cell membrane transport system, signal attains its preselected value; and in a second em
and accelerated production of collagen. 65 bodiment of the invention, the means for causing the
Additionally, this electrical treatment signal reduces second parameter of the treatment signal to increase
the concentration of free radicals which appear when causes the second parameter to increase nonlinearly
cells are damaged. These free radicals are known to during each treatment signal time period until the ?rst
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parameter of the treatment signal attains its preselected
DETAILED DESCRIPTION OF THE
value. In this second form of the invention, the means
PREFERRED EMBODIMENTS
for causing the second parameter of the treatment signal
to increase causes the second parameter of the treat An electrical medical treatment instrument 10 in
ment signal to increase as an exponential function dur cludes a microcomputer 12, a key pad 14 for entering
ing each treatment signal time period until the ?rst information relative to desired parameters into the mi
parameter of the treatment signal attains its preselected crocomputer and for activating and deactivating a treat
value. ment activation time period, a liquid crystal display
A method of increasing the metabolic activity of (LCD) 16 for displaying the status of the operation of
preselected cells and living animal tissue, including, for 10 the instrument at each point in time, a pair of output
example, damaged human tissue, includes the steps of terminals 18 and 19, an analog ampli?er/driver 20 for
situating a pair of spaced-apart electrodes in contact impressing a controlled voltage wave across the termi
with healthy animal tissue on opposite sides of an area nals 18 and 19 for controlled treatment activation time
containing damaged cells and containing cells to be periods, a digital-to-analog converter 22 for transmit
ting control signals from microcomputer 12 to am
treated and stimulated; and externally inducing a ?ow
pli?er/driver 20, a current monitor 24 for reading the
of electrical current between the electrodes through the
current ?owing through the output terminals 18 and 19,
treatment area by impressing an external bipolar voltage
and an analog-to-digital converter 26 to transmit infor
wave across the electrodes at a frequency of between
mation relative to this current flow information from
0.1 and 1.0 Hz. Effective results have been obtained 20
monitor 24 to the microcomputer so that the microcom
when the voltage impressed between the electrodes is
puter can supply information to the digital-to-analog
so regulated that the current flow resulting from the
converter 22 to control the signal to the ampli?er/
steps set out above does not exceed 900 microamperes.
driver so that the voltage wave will be such as to keep
In order to stimulate the most metabolic activity of
the current flow within the desired parameters.
the most cells, the electrodes are activated by a bipolar
Apparatus 28 of the invention includes not only the
voltage wave having a frequency of slightly less than
electrical medical treatment instrument 10 and all of its
1.0 Hz, bipolar for a period of at least 20 seconds, and
components as above described, but also ?rst and sec
then the electrodes are repositioned and the voltage
ond electrodes 30 and 31 each having a replaceable
wave reapplied. This repositioned placement can be
electrode pad 32 of any or unusual preferred construc
done by moving the electrodes on generally parallel
tion, and lead wires 34,34, each extending between one
paths with respect to each other starting at one end of of the output terminals 18 and 19 and one of the elec
the damaged area and moving to the other. Then for trodes 30 and 31.
each treatment session, the current paths between elec A direct current power supply 27 within the instru
trodes during each successive placement will lie on lines ment 10 powers the microcomputer and the other ele
parallel to each other. ments of the instrument and its output is controlled to
Another way of positioning the electrodes to treat the generate the output voltage wave as needed. It also
entire damaged area is to move the electrodes in, for forms part of the apparatus 28.
example, a counterclockwise direction between place The method of the invention includes placing ?rst
ments such that each current path between the elec 40 electrode 30 and second electrode 31 (and pads 32) in
trodes during each successive placement period will lie electrical contact with two spaced-apart healthy por
on a line passing near or through the center of the dam tions of living animal tissue (including living human
aged area, and these lines, taken together, will resemble tissue) and impressing a bipolar voltage wave of very
the spokes of a wheel. low frequency between the electrodes to cause a very
45 low current ?ow through the living tissue between the
BRIEF DESCRIPTION OF THE DRAWINGS electrodes, the wave form, frequency and current den
sity of such flow being such that a typical cell in the
FIG. 1 is a perspective view of a medical instrument
and other apparatus for micro-electric medical stimula path of such ?ow will not be damaged or otherwise
insulted.
tion of cells of living animal tissue showing the relation
ship of two electrodes forming a part of that apparatus 50 This carefully limited and controlled current flow
will tend to increase the metabolic activity of all healthy
with respect to living animal tissue to be stimulated;
cells in living tissue which come within the path of any
FIG. 2 is a block diagram of the electrical compo
of such current flow, tending to causing such cells to
nents of the apparatus of FIG. 1;
divide, thus replacing any adjacent cells which are fa
FIG. 3 is a schematic representation of an area of
tally damaged and encouraging healthy growth and/or
damaged living human tissue within a healthy area of
regrowth of such living tissue.
such tissue and illustrating a crossing pattern for succes
Early experimentation with the apparatus and
sive placement of the electrodes of the apparatus of the
method of the invention has been in conjunction with
invention for the treatment of such damaged area;
the treatment of dicubital ulcers. However, the inven
FIG. 4 is likewise a schematic representation of a
tion will be effective in treating areas of damaged or
damaged area of living animal tissue within a healthy
otherwise insulted living animal tissue from many dif
area of such tissue but illustrating a circumferential ferent causes, and in increasing the metabolic activity of
pattern for the placement of such electrodes for such cells in apparently healthy areas of living tissue. By way
purpose; and _ of example, and not by way of limitation, the invention
FIG. 5 is a plan view of an instrument panel of the is effective in treating burns of all degrees from the light
instrument of FIG. 1 as it and the liquid crystal display sunburn of a ?rst degree through very severe third
(LCD) forming a part of it will appear just prior to degree burns, wounds resulting from cutting, abrasion,
initiating a treatment activation time period. bruising, gunshot, etc.
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When individual cells are damaged, substantial con amperes give good results, while a current of between
centrations of atoms and groups of atoms each having at 500 and 600 microamperes provides optimum results.
least one unpaired electron result. If these free radicals Current ?ows approaching 1000 microamperes or 1
are not somehow supplied with their “missing” elec milliampere have proved destructive to cells in the
trons, they can be disruptive of adjacent healthy cells pathway of such ?ow.
over a period of time following the initial damage and For the purposes of research and experimentation,
their creation. The current flow induced by the appara the instrument can be provided with switch means to
tus and method of the present invention serves to supply produce not only the bipolar full wave form as dis
the needed electrons to ‘these free radicals, reducing or cussed above, but also halfway forms of positive polar
eliminating their threat to adjacent healthy cells.
ity or of negative polarity. This facility allows for the
For purposes of illustration and example, and without
opportunity to obtain test data on unipolar wave forms
limitation, FIGS. 1, 3 and 4 more or less diagrammati
which can be compared with the data and results ob
cally illustrate surface areas covering healthy living
tained using the preferred bipolar wave form. To date
tissue 36 and areas of damaged living tissue and cells 38
use of the bipolar wave form has proved much superior.
within the living tissue. 15
The treatment instrument 10 provides a current flow
In use, electrodes 30 and 31 are placed in electrical
contact with healthy living tissue on opposite sides of between electrodes 30 and 31 which meet the predeter
the damaged living tissue and cells to be treated at posi mined criteria. If the measured parameters differ from
tion, for example, as indicated in FIG. 3. As indicated, ' the parameters selected by plus or minus 15%, the mi
these electrodes (and pads 32) present a circular area of 20 crocomputer will cause the particular treatment se
approximately 2 centimeters (cm) in diameter in contact quence to be aborted by dropping the voltage potential
with the surface of the healthy living tissue 36, and are across electrodes 30 and 31 to zero. Similarly, should
situated approximately two cm from the area 38 of the parameters outside of the appropriate ranges be selected
damaged tissue. However, other con?gurations of elec by the operator, the selection will be rejected, and an
trodes, electrode pads 32 and other placements can be 25 audible and visual signal will indicate that an unaccept
used within the spirit and scope of the invention as long able parameter has been signaled.
as a current path is provided through the living tissue to To operate the instrument, the power supply 27 will
be treated between the two electrodes. be turned on to supply battery power to and throughout
With the electrodes so positioned, a voltage wave the instrument 10 by operation of an “ON/OFF”
‘form is impressed across the electrodes 30 and 31 30 switch 40 accessible at the key pad 14. If the battery
‘fthrough the instrumentality of the electrical medical
power is too low for operation, the lower level of the
'atreatment instrument 10 for a preselected treatment
LCD 16 will read:
activation period of time. Favorable results can be ob
tained when this activation time period is less than 20 LOW BATTERY
seconds or as long as 20 minutes. Longer or shorter time 35
If the battery power is adequate, the lower level of
periods appear to have no detrimental effects when the
the LCD 16 will read:
.voltage wave is applied in accordance with the other
_1;teachings of the invention.
STEP 1—SYSTEM SELF CHECKING-—PRESS
While experimentation on the use of unipolar voltage
ENTER
.j-iwave forms for particular applications continues, use of 40
ilbipolar wave forms have proved to be especially effec If the instrument is ready to function properly, the
"tive and to be devoid of the problems mentioned above upper level of the LCD 16 will signal “O.K.” under the
in connection with the use of direct current not in the legend STEP 1 and the lower half will read:
form of a bipolar wave.
STEP 2-—ENTER uAMP
The frequency of the bipolar wave form used can be 45
varied from a very low frequency to a frequency An appropriate number of microamperes will be en
slightly less than 1 Hz. Good results have been obtained tered by pressing the appropriate numbered keys on the
between 0.1 Hz and 0.9 Hz, and optimum results have key pad, for example, 500. Then the “ENTER” key will
been obtained using a frequency of 0.5 Hz. be pressed. The microamperes, in this case 500, will
The wave forms used can be from a group of wave 50 appear in the upper half of the LCD under the legend
forms, designated herein as “square wave” forms STEP 2 and the lower half of that display will read:
wherein the voltage rises in a linear fashion until a pre
determined current ?ow is reached and then is main STEP 3-—-ENTER FREQUENCY
tained until the end of a treatment signal time period
An appropriate frequency such as 0.9 Hz is entered
which is the half cycle determined by the selected fre 55 by pressing the “9” key on the key pad and also the
quency; and a group of waves designated herein as
“ENTER” key. In addition to the signal “O.K.” under
“modi?ed square waves” wherein the voltage increases
STEP 1, and the entry “500” under STEP 2, the LCD
as an exponential function until the predetermined cur
will now display “0.9” under STEP 3, and the notation
rent ?ow reaches the predetermined level and is held at
on its lower half will read:
that level until the end of that half treatment signal time
period.
STEP 4—ENTER TIME
The method of the invention calls for inducing a
An appropriate treatment activation period time,
bipolar current ?ow between electrodes through the
animal tissue to be treated, and limiting the maximum such for example, as 50 seconds will be indicated by
magnitude of that ?ow to below a level which can do 65 activation of keys 0050 on the key pad. After the “EN
damage to a typical cell in the path of the ?ow. Currents TER” key has been pressed, the notation “00:50” will
of from 20 to 900 microamperes maximum have been appear under STEP 4, and the bottom half of the LCD
proved effective, currents between 20 and 600 micro will read:
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10
To reduce the functions of the instrument 10 to its
STEP 5—PUSH START TO BEGIN TREATMENT
basic terms, the treatment signal is characterized by ?rst
When the instrument is ?rst turned on, the wave form and second electrical parameters. In this particular case,
selected from the wave form patterns stored in the mi the ?rst electrical parameter is the current of the treat
crocomputer will be that of a “modi?ed square wave,” 5 ment signal and the second electrical parameter is the
and the letter “M” will appear under the legend WAVE voltage of the treatment signal.
FORM. If a “square wave” form is desired, the The microcomputer 12, digital-to-analog converter
“WAVE” button will be pressed once, changing the 22 and analog ampli?er/driver 20 together are pro
LCD under the notation “wave form” from an “M” grammed for producing a plurality of periodic electrical
(modi?ed square wave) to an “S” (square wave). 10 treatment signals at a treatment signal frequency, each
When the machine is turned on, the notation “+/-—” treatment signal existing for a treatment signal time
will appear on the LCD under the legend POLARITY period which is an inverse function of that frequency.
and a full bipolar wave of the selected form will be The microcomputer, the key pad 14 and the LCD 16
utilized by the microcomputer in supplying potential together provide a means for receiving information
across the output terminals 18 and 19. Pressing the “P01 representative of a selected value of the ?rst electrical
+/-—” key one time will cause the microcomputer to parameter or current of the treatment signal. The cur
cause generation of a positive (+) half wave form, rent monitor 24 is a means for monitoring the ?rst elec
while pressing that key a second time will cause a nega trical parameter or current of the treatment signal. The
microcomputer 12, the digital-to-analog converter 22
tive (——) wave form to be generated. Operation of that
key for the third time will return the instrument to the 20 and the analog ampli?er/driver 20 together provide
bipolar (+/——) operation. means responsive to the means for'receiving informa
tion and the means for monitoring the ?rst electrical
The microcomputer 12 is programmed to continue
parameter (current) for causing the second parameter
operation as long as speci?c parameters are within spe
(voltage) of the treatment signal to increase during each
ci?c, preselected ranges. For example, magnitude of
current flow, magnitude of voltage of treatment signal, 25 treatment signal time period until the ?rst parameter of
the treatment signal attains the selected value, and for
treatment signal frequency. When any such parameter
maintaining the ?rst parameter of the treatment signal at
moves out of its preselected range, the treatment will be
the selected value for the remainder of such treatment
aborted by the microcomputer causing the voltage
signal time period. t
across terminals 18 and 19 returning to zero. Such an
30 In order that an entire damaged area of animal tissue
abort sequence can occur because, for example, the
and the cells in that area receive the current flow of the
electrodes are not connected to the terminals, because
invention during each treatment session, electrodes 30
electrodes are spaced too far apart, because of abnor
and 31 will have a number of different placements, each
mally low resistance, and for other reasons.
for a predetermined activation period, during each ses
Should a parameter outside the preselected range be
35 sion. Any one of a number of different schedules for
pressed into the key pad 14 by a clinician, it will not be
placements may be used effectively so long as the cur
accepted by the microcomputer as programmed, and
rent path ?owing during all of the activation periods
the display will so indicate.
includes substantially the entire area (for example the
Typically the resistance of the current path between
damaged area) to be treated. Two such schemes or
electrodes through healthy skin and other healthy liv
systems for placement of the electrodes during succes
ing tissue is relatively high with respect to the resistance
sive activation periods will be understood by consider
to current flow of the current path between electrodes
ation of FIGS. 3 and 4.
which passes through an area of damaged cells of living In FIG. 3, a crossing pattern for electrode placement
tissue. In a usual case, the greater the damage, the lower during each activation period is suggested. After a ?rst
the resistance to current flow between two electrodes 45 placement of electrodes 30 and 31 adjacent points A and
placed in contact with the living tissue on opposite sides
B as seen in FIG. 3 for a ?rst treatment activation per
of the damaged area. The resistance in the current path iod, a second placement will be made with each of the
between two equally spaced electrodes on the dry skin electrodes in contact with healthy living animal tissue
of different persons or even on different parts of the about two centimeters away from the damaged area and
body of the same person will vary. Likewise, the resis 50 in position such that the line between the electrodes will
tance to current flow between two electrodes on oppo coincide with the line CD. The next placement of the
site sides of a damaged area will also vary from one electrodes will be the same distance from the damaged
placement of electrodes to the next as the electrodes are area and in alignment with line EF, while a fourth
moved after each successive activation period to insure placement of electrodes, similarly spaced from the dam
that the entire damaged area receives the bene?ts of the 55 aged area, will be in alignment with line GH. This
treatment. Therefore, in order to treat the living animal crossing pattern is the preferred pattern.
tissue, including the cells adjacent to permanently dam However, sometimes the position of the damaged
aged cells, with a bipolar current flow of a precisely area on the human body, for example, will make it easier
de?ned magnitude as that ?ow is generated by a voltage and more effective to use a circumferential pattern of
wave of predetermined shape, it is necessary that the 60 electrode placements as suggested in FIG. 4. Here the
current ?owing through the terminals 18 and 19 and electrodes will also be placed in contact with healthy
consequently the current ?owing between those termi tissue about two centimeters from the damaged tissue
nals through the living animal tissue be monitored by and each placement successively to be in alignment
the instrument. Based on the information received by with lines AB; CH; EF; and DG.
the microcomputer from the current monitor, the mi 65 A suitable program for use in the microprocessor is as
crocomputer will cause the appropriate voltage wave follows.
form or treatment signal to be generated to keep the Although the present invention has been described
current ?ow within the desired range at all times. with reference to preferred embodiments, workers
4,738,250
11 12
skilled in the art will recognize that changes may be spirit and scope of the invention.
gnade in form and detail without departing from the
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