The issue of the use of electrotherapy for blood electrification and disease treatment

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Abstract
I have been asked to write a synopsis of the scientific uses of electrotherapy devices for the Michael Forrest case. I am a medical doctor who was Board Certified in Neurology and Psychiatry in 1985. I have worked with and done research with a variety of electrotherapy devices for twenty years. I have lectured all over the world on the electrical properties of human cells and I have written a number of papers and authored chapters in books about electrotherapy. Please refer to my CV for further background information about my credentials. It is my opinion that there is a scientific basis for the use of electrotherapy devices in the treatment of many illnesses. I have been asked by the defense team to be brief, which limits the scope of my review. Since a full review of electrotherapy would fill many books, I have included in the appendix of this paper several key documents and a number of scientific abstracts that substantiate my opinion. I have also prepared a second document entitled "Electrotherapy in the treatment of cancer and viruses -examples of papers". This second document includes many US patents that describe how electronic devices can be used for the treatment of a variety of human diseases. One of the issues in this case is the use of electrical devices (Black Box, Magnetic Pulse Generators) for the use of blood electrification with the claim that use of such devices can be used to treat infections such as viruses, bacteria and yeast and diseases such as cancer. There is a historical basis in the scientific literature for these claims.
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The issue of the use of electrotherapy for blood electrification and
disease treatment
By: Steve Haltiwanger, M.D., C.C.N.
I have been asked to write a synopsis of the scientific uses of electrotherapy devices for
the Michael Forrest case. I am a medical doctor who was Board Certified in Neurology
and Psychiatry in 1985. I have worked with and done research with a variety of
electrotherapy devices for twenty years. I have lectured all over the world on the
electrical properties of human cells and I have written a number of papers and authored
chapters in books about electrotherapy. Please refer to my CV for further background
information about my credentials.
It is my opinion that there is a scientific basis for the use of electrotherapy devices in the
treatment of many illnesses. I have been asked by the defense team to be brief, which
limits the scope of my review. Since a full review of electrotherapy would fill many
books, I have included in the appendix of this paper several key documents and a number
of scientific abstracts that substantiate my opinion. I have also prepared a second
document entitled “Electrotherapy in the treatment of cancer and viruses - examples of
papers”. This second document includes many US patents that describe how electronic
devices can be used for the treatment of a variety of human diseases.
One of the issues in this case is the use of electrical devices (Black Box, Magnetic Pulse
Generators) for the use of blood electrification with the claim that use of such devices can
be used to treat infections such as viruses, bacteria and yeast and diseases such as cancer.
There is a historical basis in the scientific literature for these claims.
In 1990, Lyman and colleagues reported that the passage of 50 to 100 microamperes of
D.C. electrical current through Aids infected blood would inactivate the Aids virus and
stop viral replication (Lyman et al., 1990). This research was presented at the First
International Symposium on Combination Therapies (an AIDS conference) in
Washington DC on March 14th, 1991.
SCIENCE NEWS briefly reported on this experiment on March 30, 1991 under the
headline:
Shocking Treatment Proposed For AIDS
“Zapping the AIDS virus with low voltage electric current can nearly eliminate its ability
to infect human white blood cells cultured in the laboratory, reports a research team at
the Albert Einstein College of Medicine in New York City. William D Lyman and his
colleagues found that exposure to 50 to 100 microamperes of electricity - comparable to
that produced by a cardiac pacemaker - reduced the infectivity of the AIDS virus (HIV)
by 50 to 95 percent. Their experiments, described March 14 in Washington D.C., at the
First International Symposium on Combination Therapies, showed that the shocked
viruses lost the ability to make an enzyme crucial to their reproduction, and could no
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longer cause the white cells to clump together - two key signs of virus infection. The
finding could lead to tests of implantable electrical devices or dialysis-like blood
treatments in HIV-infected patients Lyman says. In addition, he suggests that blood banks
might use electricity to zap HIV, and vaccine developers might use electrically
incapacitated viruses as the basis for an AIDS vaccine (Science News March 30, 1991
pg. 207).”
In 1993, (Kaali and Schwolsky) were granted United States Patent 5,188,738
ALTERNATING CURRENT SUPPLIED ELECTRICALLY CONDUCTIVE
METHOD AND SYSTEM FOR TREATMENT OF BLOOD AND/OR OTHER
BODY FLUIDS AND/OR SYNTHETIC FLUIDS WITH ELECTRIC FORCES. Device
patents are only awarded by the US Patent Office after the inventor or inventors are able
to prove to independent patent examiners that they have a reasonable scientific basis that
they have a workable device.
Kaali and Schwolsky’s patent quickly became widely known by researchers in the field
of bioelectromagnetic medicine. This patent clearly reviewed the scientific basis that
electrification of biological fluids could inactivate infectious organisms without harming
normal cells. For example, a brief quote from the patent will be reviewed.
“With the treatment system thus conditioned, the hypodermic needle is inserted into a
vein in the donor’s/recipient’s arm and blood is withdrawn, given, or recycled through
the tubing 11. As the blood passes through the electric fields produced within the
electric conductive tubing 11 it will be subjected to and treated by biologically
compatible electric current flow through the blood or other body fluid with a current
density of from one microampere per square millimeter (1 A/mm ) of electrode cross
sectional area exposed to the fluid to about two milliamperes per square millimeter (2
mA/mm ) dependent upon field strength of the electric field gradient existing between
electrodes 16 and 16A, the space between the electrodes 16, 16A and the conductivity
(resistivity) of the body fluid being treated. Recent experiments have proven that
exposure to electric fields induced by supply voltages in the range produces electric
current flow through blood of the order of 1 to 100 microamperes. Effectiveness is
dependent upon length of time of treatment in conjunction with the magnitude of the
biologically compatible current flow. For example, treatment of virus in media at 100
microamperes for 3 minutes has been observed to substantially attenuate (render
ineffective) the AIDS virus. Similar treatment at other field strength values and lengths
of time will have a similar attenuating effect on bacteria, virus, parasites and/or fungus
which are present in blood or other body fluids being treated. By controlling the length
of time and field strength values that blood is subjected to the electric field forces,
undesirable contaminants such as virus, bacteria, fungus and/or parasites will be
adequately attenuated to the point that they are rendered ineffective by the sustained
action of the electric current flow as the blood travels from the hypodermic needle 12 to
the storage bag 14, or vice versa, or in a recycling mode. The length of travel of the
blood through the sustained electric field induced current flow also can be adjusted so
that the blood is subjected to the electric field force for time periods of the order of from
one to six minutes at least. At the current values noted above this is believed adequate to
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attenuate (render ineffective) bacteria, virus (including the AIDS virus), parasites
and/or fungus entrained in blood or other body fluids, but does not render the fluids
unfit for human use or impair their biological usefulness (Kaali and Schwolsky, 1993).”
The authors of the patent describe how they could insert a needle into blood vessel and
circulate blood through tubing while subjecting the externally circulating blood to an
electric field. Subsequent exposure to an electric field that was able to create a current
flow through blood of “100 microamperes for 3 minutes has been observed to
substantially attenuate (render ineffective) the AIDS virus. Similar treatment at other
field strength values and lengths of time will have a similar attenuating effect on
bacteria, virus, parasites and/or fungus which are present in blood or other body fluids
being treated.”
The application of electricity to treat a wide variety of illnesses has been known for
hundreds of years. However researchers, clinicians and inventors worldwide escalated
their experimentation of applying electricity to the human body after 1993 because of
Lyman, Hatch, Kaali and Schwolsky’s work. Most of these electronic devices employ
AC or DC current with surface electrodes or use magnetic induction to apply electricity
into the body. Dr. Robert J. Thiel is another researcher who documented in a 1998 study
that bioelectric devices that deliver pulsed electrical frequency signals through the skin
can be useful in the treatment of a variety of infections (Thiel, 1998).
In the mid 1990’s Dr Robert C. Beck was one of these researchers who decided to
duplicate the therapy outlined by Kaali and Schwolsky in their 1993 patent. Beck
designed a device that used a circuit that varied the voltage with an alternating current
(AC) at a very low frequency. Beck’s circuit used a bi-phasic square wave that not only
allowed the current to reverse direction each half cycle, but his wave form would also
generate a large number of harmonics. Dr. Robert Beck’s use of harmonics to generate
resonant frequencies to inactivate infectious diseases was built upon prior historical
scientific experimentation. Nikola Tesla, Georges Lakhovsky and Royal Rife had all
recognized that every organ, cell, bacteria, virus, parasite, and fungus in the body has its
own resonant frequency. In addition the application of the correct frequency, waveform
and current could lead to inactivation of harmful pathogen without damaging normal
tissues, which had different resonant frequencies. Beck subsequently placed his circuit of
the internet so that other researchers could create their own devices. The “Black Box” is
one such microcurrent device.
Beck designed his microcurrent blood electrifier device to create a 50-100 micro
ampere current into the bloodstream when electrodes were applied to the skin directly
over arteries that were close to the skin surface, such as the wrists or ankles. The
application of a bi-phasic AC square wave through surface electrodes creates an electrical
current in the bloodstream by the process of electromagnetic induction. The use of
electromagnetic induction permits the electronic therapy to be applied externally, without
the need for implanting electrodes into the arteries. Dr. Beck's Magnetic Pulse
Generator is another device that was designed to induce electrical current into the
bloodstream at a distance without using surface electrodes.
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It takes no great stretch of the imagination to understand that a scientist like Dr. Bob
Beck, who was a physicist, holding a Ph.D in physics from the University of Southern
California, a former consultant to the Sandia Corp, a Senior Staff Scientist at Eyring
Research Institute, and a former consultant to the US Navy could design devices that
electrified blood, while the blood remained in the internal tubing of the blood vessels.
Moving the blood outside of the body in plastic external tubes to electrify the blood
confers no special properties that could not also be achieved by a competent scientist who
could devise electronic equipment capable of creating the proper electrical field strength
within the blood vessels of the body. It is erroneous to believe that circulating blood
through plastic tubing to electrify the blood is superior to electrifying blood in the blood
vessels of the body. It is also erroneous to believe that the blood within the blood vessels
can not be electrified by the use of electronic devices capable of generating the proper
electric field strength.
Scientific explanations exist that explain how external electromagnetic devices that
employ microcuurent technology like the “Black Box” and magnetic inducers like
the “Magnetic Pulser” and the “Magnetic Multi-Pulser” can affect humans. In the
next section I will briefly outline the electronic features of the body that make this
possible.
Endogenous weak electric fields are naturally present within all living organisms and are
apparently involved in pattern formation and regeneration (Nuccitelli, 1984).
The body uses electricity (biocurrents) as part of the body’s mechanism for controlling
growth and repair (Borgens et al., 1989). Some of these biocurrents travel through the
nerves while other biocurrents travel through the liquid crystal semiconducting proteins
of the connective tissue (Ho, 1998; Oschman, 2000).
Tissues of the body that are injured have a higher electrical resistance than the
surrounding tissue (Wing, 1989). The cell membranes of these tissues become less
permeable to the flow of ions and more electrically insulated. This results in the
endogenous bioelectric currents avoiding these areas of high resistance (Wing, 1989).
The reduction in electrical flow through an injured area is one factor that interferes with
healing. Wing, in his 1989 paper, is one of many researchers who have described how the
use of microcurrent therapy with attached electrodes could accelerate healing of injured
tissue.
Increasing the electrical resistance of a tissue by injury or disease will impede the flow of
healing biocurrents through that tissue (Becker, 1985). A decrease in the flow of natural
electrical currents through an injured area also results in a decrease of the electrical
potential of the membranes of cells in the affected area. This electrical property of cell
membrane charge is known as membrane capacitance.
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Electrical properties of cells
The cell membrane is a dividing structure that maintains biochemically distinct
compartments between the inside (intracellular) and outside (extracellular) spaces
(Marieb 1998).
In order to maintain balance in intracellular fluid and electrolytes, water, sodium and
potassium are in constant motion between the intracellular and extracellular
compartments (Edwards 1998). The passage of electrically charged ions through a
membrane will create a flow of electric currents through the membrane. These ions in
turn will affect the metabolism of the cell and the potential of the cell membrane.
The lipid structure of a cell membrane makes it relatively impermeable to the passage of
charged molecules. Therefore charged molecules must cross through ion channels. Ion
channels are transmembrane protein molecules that contain aqueous pores connecting the
inside of the cell to the extracellular space. These channels can open and shut in response
to a variety of signals. The passage of charged molecules through ion channels in the cell
membrane endows the membrane with an electrical conductive property allowing for
inward and outward current flows (Aidley and Stanfield, 1996). This is one factor that
establishes electric circuits in biological tissues.
So it would be expected that all living cells of the body would naturally have a weak,
electric current flowing through them. In fact there are bioelectrical circuits continually
circulating throughout the body (Stanish, 1985).
The buildup of different concentrations of mineral ions on either side of the membrane
also helps create a membrane potential and endows cell membranes with the electrical
property of capacitance.
Capacitors are well known electronic components that are composed of two conducting
sheets or metal plates separated by a thin layer of insulating material. Cells contain
several forms of biological capacitors, which consist of an insulating material (the
membrane) covered on both sides by collections of charged dissolved minerals, which
serve the same function as a conducting metal plate. Because the exterior cell membrane
and the membranes of cell organelles like the mitochondria in animals and the
chloroplasts in plants are biological capacitors they have the capacity to accumulate and
store charge and hence energy to be given up when needed.
Energy is taken from a circuit to supply and store charge on the plates. Energy is returned
to the circuit when the charge is removed. The area of the plates, the amount of plate
separation and the type of dielectric material used all affect the capacitance. The
dielectric characteristics of a material include both conductive and capacitive properties
(Reilly, 1998). In cells the cell membrane is a leaky dielectric. This means that any
condition, illness or change in dietary intake that affects the composition of the cell
membranes and their associated minerals can affect and alter cellular capacitance.
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A cell or human body is coupled to an electric field in proportion to its capacitance such
that the greater the frequency of the electrical field the greater the current flow in the cell
or body. For soft tissues low frequency natural or applied electrical fields create currents
that are conducted primarily along the surface of cells (Adey 1993a). When high
frequency fields are applied with external signal generators, such as microcurrent
devices, magnetic pulsers or the plasma tubes of Rife devices, electrical charging of
the cell membranes occurs causing an increase in cell membrane capacitance and
increased conduction of current through the cell membranes (Haltiwanger, 2003). This
means that devices that generate low frequency currents will have different biological
effects than devices that generate high frequency currents. It can thus be seen that the
frequency a device generates is an important factor in eliciting different biological
effects.
Because cell membranes naturally have capacitance this makes the cell membrane
frequency-dependent conductors. At high frequencies a greater percentage of current
will flow into and out the cell as a circuit loop. Higher frequency fields can strongly
affect cell membrane permeability, which in turn can affect nutrient entry into the cells
and toxin release from the cells and the connective tissues of the body.
In summary an increase in cellular membrane capacitance may: change membrane
permeability, increase cellular nutrient and mineral entry in to the cell and facilitate
release of impregnated toxins from the membrane and cell interior.
Scientific research has proven that cells are electromagnetic in nature, they generate
their own electromagnetic fields and they are also capable of harnessing external
electromagnetic energy of the right wavelength and strength to communicate, control and
drive metabolic reactions (Adey, 1988, 1993a, 1993b; Becker, 1990).
Normal cells possess the ability to communicate information inside themselves and
between other cells. The coordination of information by the cells of the body is involved
in the regulation and integration of cellular functions and cell growth. When tissues of the
body are injured the cells in and around the injured area are sent extracellular signals that
turn on repair processes. The stimulus for repair has conventionally been considered to be
by chemical agents such as cytokines and growth factors; however over the last five
decades through the work of Robert O. Becker and others it has become apparent that
mechanical, electric and magnetic signals also have a regulatory influence (Becker, 1960,
1961, 1967, 1970, 1972, 1974, 1990).
Among the electrical properties that cells manifest are the ability to conduct electricity,
create electrical fields and function as electrical generators and batteries. In electrical
equipment the electrical charge carriers are electrons. In the body electricity is carried by
a number of mobile charge carriers as well as electrons. Although many authorities would
argue that electricity in the body is only carried by charged ions, Robert O. Becker and
others have shown that electron semiconduction also takes place in biological polymers
located in the connective tissues of the body (Becker and Selden, 1985; Becker, 1990).
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Connective tissue is a strong composite tissue composed of liquid crystalline collagen
fibers embedded in a gel-like ground substance (Oschman, 1984, 2000). “The connective
tissue is a continuous fabric extending throughout the animal body, even into the
innermost parts of each cell (Oschman, 2000).”
Intracellular and extracellular biological liquid crystal molecules inherently possess the
property of resonance according to the laws of physics. Biological molecules, atoms
and even electrons have special resonant frequencies that will only be excited by energies
of very precise vibratory characteristics. When two oscillators are tuned to the same
identical frequency the emission of one will cause the other to respond to the signal and
begin to vibrate. Resonance occurs in biological molecules or even whole cells when
acoustical or electric vibrations emitted from a generating source match the absorption
frequency of the receiving structure producing an energy transference, which amplifies
the natural vibrational frequency of the cell or the cell component (Beal, 1996a, 1996b).
All metabolic reactions of a cell are controlled by a complex interaction of regulatory
processes. These regulatory processes are usually defined in biochemistry by their
chemical properties, however according to Brugemann and others, the internal chemical
regulatory forces are in turn controlled by electromagnetic oscillations, which are
biophysically specific (Brugemann, 1993). This physical principle makes it possible to
obtain very specific metabolic responses when very weak electrical fields are applied or
created in the body, which exactly match the frequency codes of the chemicals involved
in the metabolic process you want to affect. This is one reason that frequency specific
equipment like the “Black Box”, magnetic inducers like the “Magnetic Pulser” and
“Rife frequency generators” can exert biological effects on humans.
When an electromagnetic field that possesses the resonant frequency of a biological
molecule is generated in the body, conducting molecules of that particular type will
absorb energy from the field and undergo induced electron flow.
A fact that is not widely understood is that the cells of the body are exquisitely responsive
to electrical frequencies of exactly the right frequency and amplitude (Adey, 1993a,
1993b). Researchers such as Ross Adey and others have discovered that the cells of the
body have built in electromagnetic filters so they only respond to electromagnetic fields
of particular frequencies and amplitudes (Adey, 1993a, 1993b).
Improving the electrical conductance in the connective tissues will improve healing and
improve cell membrane charge. Correction of tissue inflammation and connective tissue
toxicity can improve the electrical functions of the connective tissue. Therefore the
composition and degree of toxicity of the connective tissue will affect the electrical field
and the flow of biocurrents in the connective tissue. The electrical field and biocurrent
conduction in the connective tissue in turn will affect: cell membrane capacitance,
permeability of the cell membrane, signaling mechanisms of the cell membrane,
intracellular mineral concentrations, nutrient flow into the cell and waste disposal (Wing,
1989; Oschman, 2000). There exists scientific justification that electronic devices like the
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“Black Box” and “Magnetic Pulsers” can help reestablish electrical current flow in
diseased tissues and assist in both healing and the release of stored toxins.
The phenomenon of magnetic induction helps explain how Magnetic Pulsers work
The application of a varying magnetic flux to an area of the body will induce an electric
field, along the perimeter of the area according to the basic laws of electromagnetism. In
1831 Michael Faraday, one of the first electrical pioneers, was the first person to describe
the phenomenon of electromagnetic induction. He discovered that he could produce a
measurable electrical current in a wire conductor simply by moving a magnet near the
wire. This discovery became the basis for Faraday’s Law of Induction, which is a basic
law of electromagnetism (Jones and Childers, 1990).
When varying magnetic fields are applied to human tissues that contain free (or mobile)
charge carriers, these charge carriers will be accelerated by the electric field thereby
generating eddy currents in the tissues. The induced electric field or the generated current
depends upon the rate of change, dB/dt, of the magnetic field, with the electric field or
current increasing with increasing rate of change. According to Edmonds, “When living
cells are exposed to sinusoidal or otherwise time-varying magnetic fields it is likely that
electric fields and thus currents will be induced within them (Edmonds, 2001).
The activation of biological processes in the human body takes place within a large range
of electric fields. If the magnetic device induces too high an electrical field it will elicit
the action potentials of excitable cells in the region. The elicitation of cellular action
potentials is undesirable since it may lead to disturbing symptoms in the patient or give
rise to undesirable physiological reactions. For example, the effects of large induced
electrical fields can cause flexing of muscles due to activation of muscle cells or
elicitation of nerve impulses due to activation of neural cells.
Bone contains proteins that have piezoelectric properties so mechanical stress will create
endogenous electrical currents. Endogenous electrical current densities under physiologic
conditions approximate 1 Hz and 0.1 - 1.0 microA/cm2 (MacGinitie et al., 1994).
The endogenous current density in many organs and tissues lie in the range of 0.1-10
mA/m2 (Bernhardt, 1979). Current densities less than this in general are thought to
produce few biological effects; however the work of Jerry Jacobson has shown that even
weak picotesla magnetic fields do produce noticeable biological effects (Jacobson et al.,
1995).
Time-varying magnetic fields that induce current densities greater than approximately 1-
10 mA/m2 have been reported by many researchers to produce various alterations
including cell growth acceleration, enzyme activation, and changes in the metabolism of
carbohydrates, fats, proteins and nucleic acids (Tenforde, 1990).
The main goal in treating biological tissues i.e. bone healing, wound healing, nerve
growth, and angiogenesis with a time- varying magnetic field is to induce tissue
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currents. These currents must have enough intensity and duration to be capable of
activating cellular signaling processes and extracellular signals, thus initiating enzyme
reactions, membrane transport, cell proliferation and differentiation and other biological
processes without being so strong that they create undesirable physiological reactions.
The production of electrical currents and magnetic fields in the body
It is now well recognized in medicine that electrical currents and magnetic fields are
continually being produced in the body at all times. For example, cardiologists measure
the electrical currents produced by the beating heart and neurologists measure the
electrical activity of the brain.
Electricity in the body comes from the food that we eat and the air that we breathe
(Brown, 1999). Cells derive their energy from enzyme catalyzed chemical reactions,
which involves the oxidation of fats, proteins and carbohydrates. Cells can produce
energy by oxygen-dependent aerobic enzyme pathways and by less efficient fermentation
pathways.
The specialized proteins and enzymes involved in oxidative phosphorylation are located
on the inner mitochondrial membrane and form a molecular respiratory chain or wire.
This molecular wire (electron transport chain) conducts electrons donated by several
important electron donors through a series of intermediate compounds to molecular
oxygen, which becomes reduced to water. In the process ADP is converted into ATP.
The biological activities of cells, tissues and the bloodstream thus generate electrical
currents in the body and electrical fields that can be detected on the skin surface; however
the laws of physics require that the generation of an electrical current always results in
the production of a corresponding magnetic field in the surrounding space. A current
flowing through a volume conductor always gives rise to a magnetic field (Jackson,
1975).
Through the use of a piece of equipment called a SQUID (Superconducting Quantum
Interference Device) magnetometer scientists have now objectively proven that there is a
weak magnetic energy field around the human body. This biomagnetic field arises
because of physiologic activities within the human body, which in electrical terms is a
volume conductor.
Biomagnetic signals are thought to arise from intra-cellular currents that are produced by
muscular contraction or neural excitation of tissue cells (Rottier, 2000). The current
produced in the cells flows out of the cells through cell membrane protein connections
and cell ion channels into the extracellular matrix creating bioelectric current flows in the
body. When this natural electrical current flows in the body a weak magnetic field is also
produced outside of the body (Rottier, 2000). According to the physics principle of
induction, the creation of an electric current in a material will always induce a
corresponding magnetic field and the movement of conductive material in a magnetic
field or the exposure of a conductive material to a fluctuating magnetic field will induce
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an electric current in the material. Thus the application to the body of an appropriate
fluctuating magnetic field will produce electrical activity in the tissues and cells of the
body.
Scientists and practitioners for centuries have used electronic equipment to measure
bioelectrical fields that are present on the skin. [Field potentials that appear at the surface
of the body are the basis of clinical electrocardiography (ECG), electromyography
(EMG), electroencephalography (EEG), etc.] The detection of the magnetic component,
however had to wait until 1963 when researchers at Syracuse University first measured
the magnetic field produced by the heart, which is one-millionth the strength of the
earth's magnetic field (Baule et al., 1963).
In 1971, equipment sensitive enough to measure the brain’s weak biomagnetic field,
which is even 100 times weaker than the heart’s magnetic field, was developed (Cohen,
1972).
Uses of electromagnetic devices in medicine
Thousands of papers now exist on the use of electrotherapy devices in the treatment of
human diseases. I have included a bibliography in this report that lists hundreds of
studies. I have included a list of selected abstracts that gives more details of some of
these medical papers. Because I was asked to only write a short synopsis on the uses of
electrotherapy for this case I will only discuss several other examples such as bone
healing, wound healing and nerve repair.
For example, both magnets as well as electromagnetic therapy devices have been
reported to relieve physical symptoms such as pain and edema and facilitate the healing
of broken bones (Barker, 1984). Electromagnetic devices are now widely used by
orthopedists in the treatment of fractures. Although the underlying physiological
mechanisms are still not completely understood, several medical studies have shown that
pulsating electromagnetic fields can stimulate bone formation and bone graft
incorporation (Cruess et al., 1983; Rubin et al., 1989). The United States Food and Drug
Administration has already approved this form of therapy for the treatment of delayed
and non-union fractures.
The use of pulsating electromagnetic fields has also been reported to be useful in
promoting healing of bedsores (Ieran et al., 1990) and in neuronal regeneration (Kort et
al., 1980). Many more examples can be seen in Appendix 5: ELECTROMEDICINE: The
Textbook of the American Academy of Pain Management by Daniel L. Kirsch, Ph.D. and
Fred N. Lerner, Ph.D.
I have referenced the key points of my argument to document that my opinion is backed
by prior scientific research. In summary, it is my opinion that both published peer
reviewed scientific papers and US patents substantiate many of the medical claims made
by Michael Forrest.
11
References:
1. Adey WR. Physiological signaling across cell membranes and cooperative
influences of extremely low frequency electromagnetic fields. In: Biological
Coherence and Response to External Stimuli, H. Frohlich, ed., Heidelberg,
Springer-Verlag, pgs 148-170, 1988.
2. Adey WR. Whispering Between Cells: Electromagnetic fields and regulatory
mechanism in tissue. Frontier Perspectives 1993a;3(2):21-25.
3. Adey WR. Electromagnetics in biology and medicine. In Modern Radio Science,
(ed. H. Matsumoto). Oxford, England: Oxford University Press, pgs 277-245,
1993b.
4. Aidley DJ, Stanfield PR. Ion Channels: Molecules in Action. Cambridge, UK:
Cambridge University Press, 1996.
5. Barker AT. Pulsating electromagnetic field therapy for the treatment of tibial non-
union fractures. Lancet 8384 (1): 994-996, 1984.
6. Baule GM, McFee R. Detection of the Magnetic Field of the Heart. Am Heart J
1963;66, 95-96.
7. Beal J. Biosystem Liquid Crystals: Several hypotheses relating to interacting
mechanisms which may explain biosystem and human hypersensitivities to
electric and magnetic fields. 1996a. Website:
http://www.cyberspaceorbit.com/BIOSYSTEMLIQUIDCRYSTALSbyJamesBeal
.htm.
8. Beal JB. Biosystems liquid crystals & potential effects of natural & artificial
electromagnetic fields (EMFs) 1996b. Website:
http://frontpage.simnet.is/vgv/jim1.htm
9. Beck R March 16, 1996 Experimental in vivo blood clearing device for
eliminating viruses pathogens, microbes, bacteria, fungi, and parasites. Robert
Beck, Santa Ana, California.
10. Becker RO. The bioelectric field pattern in the salamander and its simulation by
an electronic analog. IRE Trans Med Electron 1960; ME-7:202.
11. Becker RO. The bioelectric factors in amphibian limb regeneration. Journal of
Bone and Joint Surgery 1961;43A:643-656.
12. Becker RO. The electrical control of growth processes. Medical Times 1967;95:
657-669.
13. Becker RO. Stimulation of partial limb regeneration in rats. Nature 1972;235:109-
111.
14. Becker RO. The basic biological data transmission and control system influenced
by electrical forces. Ann N Y Acad Sci 1974;238: 236-241.
15. Becker RO. Cross Currents. London, England: Bloomsbury Publishing, 1990.
16. Becker RO, Murray DG. The electrical control system regulating fracture healing
in amphibians. Clin Orthop Rel Res 1970;73:169.
17. Becker RO, Selden G. The Body Electric. New York: W. Morrow and Company
Inc, 1985.
18. Bernhardt J. The direct influence of electromagnetic fields on nerve and muscle
cells of man within the frequency range of 1Hz to 30MHz. Radiat Environ
Biophys 1979;16:309-323.
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19. Borgens RB, Robinson KR, Vanable JW, McGinnis ME. Electric Fields in
Vertebrate Repair. NY: Alan R. Liss, 1989.
20. Brown G. The Energy of Life: The Science of What Makes Our Minds and Bodies
Work. New York, NY: The Free Press, 1999.
21. Brugemann H. Bioresonance and Multiresonance Therapy (BRT). Brussels,
Belgium: Haug International, 1993.
22. Cohen D. Magnetoencephalography: detection of the brain's electrical activity
with a superconducting magnetometer Science 1972;175: 664-666.
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refandres/papers_articles.html
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Edge, NJ: World Scientific, 1998.
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276-282, 1990.
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31. Jones ER, Childers RL. Contemporary College Physics. Reading, MA: Addison-
Wesley Publishing Company, 1990.
32. Kaali S, Schwolsky PM. United States Patent 5,188,738 ALTERNATING
CURRENT SUPPLIED ELECTRICALLY CONDUCTIVE METHOD AND
SYSTEM FOR TREATMENT OF BLOOD AND/OR OTHER BODY FLUIDS
AND/OR SYNTHETIC FLUIDS WITH ELECTRIC FORCES.
33. Kort J, Ito H, Basset CAL. Effects of pulsing electromagnetic fields on peripheral
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34. Lyman WD, et al. Lab Test Results of HIV inactivation by electric current:
Reporting Inactivation of AIDS Virus by Electric Current. First International
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Increase Protein Synthesis in Articular Cartilage Explants. J Orthop Res 12: 151-
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Benjamin/Cummings Publishing Company, 1998.
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13
38. Oschman JL. Energy Medicine: The Scientific Basis. Edinburgh, England:
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electromagnetic fields. J Bone Joint Surg [Am] 71: 411-416, 1989.
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Appendix 1: pgs 14-26. Lab Test Results of HIV inactivation by electric current
from Appendix E. Paper by W. Lyman, et al. Reporting Inactivation of AIDS Virus
by Electric Current William D. Lyman, Irwin R.Merkatz, William C. Hatch and
Steven C. Kaali pgs 14-26
Appendix 2: pgs 27-40. United States Patent 5,188,738 Kaali, et. al. * Feb. 23, 1993
Appendix 3: 41-47. Thiel RJ. Bioelectrical Stimulation for People with Patterns
Consistent with Certain Chronic Infections. ANMA Monitor 1998;2(4):5-9.
Appendix 4: 47-100. Electrical Stimulation And Wound Healing References
(Abstracts)
Appendix 5: 100-108. ELECTROMEDICINE: The Textbook of the American
Academy of Pain Management by Daniel L. Kirsch, Ph.D. and Fred N. Lerner,
Ph.D.
14
Appendix 1.
Lab Test Results of HIV inactivation by electric current from Appendix E
Paper by W. Lyman, et al. Reporting Inactivation of AIDS Virus by Electric
Current
William D. Lyman, Irwin R.Merkatz
William C. Hatch and Steven C. Kaali
Departments of Pathology,
and Obstetrics & Gynecology
Albert Einstein. College of Medicine,
1300 Morris Park Ave., Bronx, N.Y.10461
William D. Lyman, Irwin R.Merkatz
William C. Hatch and Steven C. Kaali
Departments of Pathology,
and Obstetrics & Gynecology
Albert Einstein. College of Medicine,
1300 Morris Park Ave., Bronx, N.Y.10461
SUMMARY
In this report, we present the results of double-blinded studies on the use of direct electric
current to alter the infectivity o£ HIV-1 for susceptible cells in vitro. Two lymphoblastoid
cell lines (H9 and CEM-SS) were exposed to aliquots of the RT strain of HIV-1 treated
with direct current. Results of these studies show that virus treated with currents from 50
to 100 microamperes (ìA) has a significantly reduced infectivity for susceptible cells.
These experimental currents were equal to 3.85 and 7.7.ìÁ/mm2 current densities
respectively. The reduction of infectivity was dependent upon, the total electric charge
(ìA x min) passing through the chamber to which the virus was exposed. Viral infectivity
was determined by two independent measures: a syncytium-formation assay which can
be used to quantify the production of infectious particles; and. a reverse transcriptase
assay which is an index of viral protein production. Additional experiments demonstrated
that the currents employed were biocompatible. Uninfected H9 cells were exposed to the
same conditions used for the viral aliquots.
There was no significant change in the percentage of viable uninfected cells exposed to
any of the currents tested. Therefore, because biocompatible direct electric current
attenuates the infectivity of cell-free virus, this treatment may allow development of new
strategies to prevent transmission of HIV-1 through either treating the general blood
supply or developing alternative barrier contraceptive devices. Additionally,
biocompatible electric. current may be applicable for the direct treatment of AIDS
patients by utilizing either extracorporeal systems or self contained indwelling electrodes.
15
Lastly, because the virus is being attenuated, electric current may also render treated
HIV-1 suitable for vaccine development.
Key words: HIV-1, AIDS, treatment, suppression of infectivity, electricity
INTRODUCTION
The number of individuals infected by the human immunodeficiency virus type-1 (I-
(HIV-1) continues to increase on a world-wide basis (1). A significant percentage, if not
all, of these individuals will eventually develop the acquire d immunodeficiency
syndrome (AIDS) (2)- While horizontal transmission in the homosexual. population may
be contained or decreasing (3), heterosexual transmission and infection through
contaminated blood supplies continues to increase (4). Additionally ver tical transmission
from infected females to their fetuses is also on the rise with a resultant increase in the
number of children with AIDS (5). New strategies, therefore, must be devised in order to
limit more effectively the spread of this virus.
In this regard, three principal approaches are currently being investigated. In order to
decrease susceptibility to the consequences of infection, vaccines are being sought which
will induce the production of protective antibodies (6). As treatment modalities, the use
of soluble antagonists to block the receptor for HIV-1 is being studied (7) as are
pharmacologic agents such as nucleic acid analogs which can interfere with the
transcription of viral genomic sequences (8). Each of these systems has------------ and
limitations and to date none has proven completely effective.
Because heat or light in combination with drugs and dyes can inactivate viruses
including HIV-2 in vitro (9), others have suggested the use of these forms of energy to
treat .. AIDS patients. The results of studies using heat have not been peer- reviewed and
are therefore impossible to evaluate. The use of light with drugs ["photopheresis"] (10)
appears to be efficacious although this treatment may be limited by drug toxicity and the
potential long-term effects of ultraviolet radiation on blood c ell nucleic acids. Also, by
its nature, this last system may not be suitable for the treatment of tissue-associated virus.
As result of our interest in the use of electric current to alter biological systems , we
focused our investigations on the ability of direct electrical current at biocompatible
levels to alter the infectivity of HTV-1 for susceptible CD4 positive cell s in vitro.
MATERIALS AND METHODS
16
Electrical treatment of HIV 1:
The RF strain of HIV-I (AIDS Reagent Program) was cryopreserved prior to treatment at
-70°C. Fur treatment, a sample of virus was thawed and maintained on ice at 4°C . Ten
microliters (ìl) of HIV-1 at a concentration of 105 infectious particles per ml were placed
into a chamber which included a pair of platinum electrodes 1mm apart permanently
mounted into a well 1.56mm in length an d 8.32mm in depth equal to 12.9 ìl volume
capacity. The chamber was connected to a power supply capable of creating constant
direct current. The viral aliquots were exposed to direct currents ranging from 0
microamperes ( ìA) for up to 12 minutes to 100ìA for up to 6 minutes. Intermediate
currents of 25, 50 and 75ìA were used to expose similar viral aliquots. Under these
conditions, for example, 0, 50 and 100ìA represent 0, 3.85 and 7 .7ìA/mm2 current
densities respectively. The current was monitored throughout the experiment. A matrix of
current and time employed is shown in Table 1.
After the exposure of virus to electric current, the contents of the chamber were removed
and placed into sterile microtubes. Five ìl of each sample were removed and diluted with
95ìl tissue culture medium supplemented with 10% fetal calf serum (FCS) for subsequent
assays.
Syncytium-formation assays:
This assay was performed as previously described by Nara et al (11). Briefly, 105 CEM-
SS cells were dispensed into poly-L-lysine coated microliter wells. Thereafter, tenfold
dilutions o f H9 cells incubated with the treated HIV-1 samples were co-cultured in
triplicate for up to 4 days with the CEM-SS cells. Identical wells were prepared with
control uninfected and infected cells. The wells were examined for syncytium formation
at 2 and 3 days and quantified using an inverted microscope.
RReverse trascriptase assay:
Uninfected H9 cells, were pelleted at 1,000 rpm for minutes at room temperature, the
supernatant was decanted and the cells were resuspended in 100ìl treated viral sample.
The cells were incubated for up to 6 hours with the viral samples. At the end of the
incubation time, the viral/cell suspensions were centrifuged at 1,000 RPM for 5 minutes
and the supernatant decanted. The cell pellet was then resuspended in 5ml of RPMI, 10%
FCS and placed into a T25 tissue culture flask and maintained at 370C, 5% CO2 in a
humidified chamber. At 2 day intervals (beginning at day 2}, 1ml of the cell suspensions
was removed from each sample and centrifuged at 1,000 rpm for 5 minutes in order to
pellet the cells. The supernatant was subsequently centrifuged at 14,000 RPM for I5
minutes. The pellet was resuspended in suspension buffer and assayed using standard
methodology employing Mg+ + as the divalent cation poly (rA) oligo d(T) 12-18 as
template primer, and tritiated thymidine (3H-TdR) which comprise the reaction mixture.
17
Known HIV positive and negative control samples were included in each assay for
reference. Thirty ìl of the reacti on mixture were added to each 10 ìl viral sample and
incubated at 37 0C for 60 min. Samples were then incubated with 1ml of cold quench
solution on ice for 15 minutes and filtered through a Millipore manifold. Chimneys were
rinsed first with wash solution and followed by cold 95% ethanol. The filters were dried
by vacuum and counted in scintillation fluid. Reverse transcriptase activity is expressed
as counts per minute (cpm) and is considered positive only if cpm are at least five times
greater than the cpm obtained with HIV negative control samples.
Biocompatibility of electric currents/time:
To determine if the electric currents used were in a biocompatibility range of energy,
uninfected H9 cells were exposed to distinct currents for different amounts of time. The
H9 cells were washed two times in Hanks Balance Salt Solution (HBSS). Thereafter, the
cells were resuspended in RPMI, 10% FCS at a concentration of 106 cells per ml, Ten ìl
of the cell samples were placed into the reaction c hamber. The cell samples were then
exposed to 0, 50 or 100ìA for 0, 3 or 6 minutes. At the end of each test, the cell sample
was removed from the chamber and approximately 10ìl of the sample was mixed with
90ìl of trypan blue. The number of viable cells w as determined by trypan blue exclusion
using a hemocytometer and tight microscope. Results are expressed as percentage of
viable cells from the total of all cells. At least 200 cells per field were counted.
Statistical analysis:
Results of the syncytium-formation and reverse transcriptase assays were tested for
statistical significance by the Student's t test and analyses of variance.
RESULTS
Syncytium-formation assay:
Using this index of HIV-1 infectivity, it was determined that exposing virus to direct
electric current suppressed its capacity to induce the formation of syncytia. Figure 1
shows a representative e xperiment and Table 2 shows the Croup data for 3 separate
experiments. As can be noted in Figure l, a statistically significant (p<0.001) reduction in
sycytium number was observed and this reduction was dependent upon the current
applied to the viral i solate. At three different viral dilutions, there were analogous results
in that a total charge of 200ìA x min (25ìA for 8 minutes) reduced the number of syncytia
from 50 to 65% while a charge of 300ìA x min (50ìA for 6 minute s, 75ìA for 4 minutes
or 100ìA for 3 minutes) resulted in 90% reduction.
18
Reverse transcriptase assays:
The direct electric currents to which HIV-1 was exposed also reduced reverse
transcriptase activity. Five separate experiments were conducted and a representative
experiment is shown in Figure 2 and the ;coup data are included in Table 3. As can be
seen in Figure 2, there was a significant decrease in the amount of reverse transcriptase
activity after exposure of the virus to either 50ìA for 3 or 6 minutes. An equivalent
reduction in reverse transcriptase activity was also noted with exposure to, 100ìA for 3
minutes and almost ablation of reverse transcriptase activity was seen with exposure of
the viral isolate to 100ìA for 6 minutes. The group data (Table 3} show that after
exposure to 50ìA for 6 minutes, there was a 44% reduction in activity and treatment of
virus with 100ìA for 6 minutes resulted in a 94% reduction. An analysis of variance
indicates that t he decrease in reverse transcriptase activity was statistically significant (p
<0.0001).
Biocompatibility of the electric currents/time:
The results of a viability analysis using trypan blue exclusion criteria applied to
uninfected cells exposed to the different currents and times used far these studies are
shown in Table 4. The viability of H9 cells, after exposure to 100ìA fur either 3 or b
minutes, did not show a significant decrease when compared to the 0 Current control.
After maximum treatment at 100ìA for 6 minutes, cell viability was 93%. Interestingly, in
other preliminary experiments in which HIV-infected H9 cells were used, the results
show that at 100 ìA there may have been a significant decrease in the number of viable
cells. That is, while an insta ntaneous pulse of 100 ìA did not affect the viability of
infected cells, at 3 and 6 minutes of exposure to 100 ìA, a decrease in viability was noted.
This decrease was time dependent in that exposure to 100 ìA far 3 min utes resulted in a
viability of 83% while 100 ìA for 6 minutes resulted in a viability of 80%. Although
these data are provocative, they only represent a preliminary experiment and require
further investigation.
With respect to the possibility that the electric current was transduced into heat, the
calculated rise in temperature within the chamber was determined to be less than 1°C. In
order to verify this, a temperature microprobe was introduced into the cham ber
containing tissue culture medium alone. Results of these studies are shown in Table S.
Similar results were obtained when H9 cell-containing medium was placed in the reaction
chamber. The data indicate that for the currents and times used for these ex periments,
there was no alteration in the temperature of the chamber.
DISCUSSION
19
The results reported here demonstrate that HIV-1 treated with direct electric currents
from 50 to 100ìA has a significantly reduced infectivity for susceptible cells in vitro. This
reduction o f infectivity correlates with the total electric change passing through the
chamber. Although extrapolation of these data predicts that ablation of HIV infectivity
may be possible, and additional preliminary data support this prediction, the expectation t
hat some virions may still escape the electrical effect cannot be discounted. Nevertheless,
the .therapeutic potential of electric current may reside in its ability to lower the viral titer
to subclinical significance or in its incorporation into a strate gy analogous to that of
other therapies in which repeated cycles of treatment eventually achieve remission or
cure.
The data presented in this report are based on both quantitative and quantal
determinations of viral infectivity. Although the syncytium-formation assay can be used
to quantify the number of infectious viral particles, this use with respect to HI V-1 may
be abridged because of the ability of free fusigenic peptide (gp41) to induce syncytia by
itself. Therefore, while syncytia were observed at some dilutions of electrically-treated
virus, this may simply represent the presence of soluble gp41 in th e tissue culture
medium. We believe that the correlation between total charge and reduction in syncytium
number more adequately reflects the ability of direct electric current to reduce HIV-1
infectivity.
This belief is also supported by the results of the reverse transcriptase assays.
Although a decrease in HIV-1 reverse transcriptase does not assure reduced
infectiousness of this virus for Susceptible cells; we feel that, taken together with the
syncytium-formation data, the results indicate that significant attenua tion of HIV-I
infectivity is achieved by treatment with direct electric currents.
With respect to the biocompatibility of the electric currents and total charges reported
here, two separate sets of evidence are applicable. The first has to do with the results
showing that, by trypan blue exclusion, no significant cyt otoxicity was induced in by any
total charge tested. The other evidence is obtained from reports which clearly indicates
that the amount of electricity used for these experiments is significantly below presently
used therapeutic electric currents which ar e in the milliampere range (12-16).
Rather than negative effects, exposure of cells to electric current may actually have
positive consequences for resistance to infection in that important cellular
electrochemical changes correlate with enhancement of specific enzymatic activities. In
particular, a facilitation of succinate dehydrogenase (SDH) and ATPase activity has been
observed (12,15). Both of these enzymes are associated with the oxidative capacity of the
cell. Specifically, it has been suggested that an elec trochemical reaction occurs between
mitochondrial membrane-bound H+ ATPase and ADP leading to the formation of ATP.
Therefore, exposure of cells to direct electric current may directly or indirectly increase
20
energy resources within a cell and facil itate cell metabolism. This, in turn, may actualIy
render a cell less susceptible to the effects of viral infection.
In summary, the data presented here indicate that biocompatible direct electric current
significantly reduces the infectivity of HIV-1. Continuing investigations are exploring the
mechanisms through which this effect is mediated. The in itial focus of these experiments
is centered on the potential role which ionic and molecular species generated by
electrolysis may have on the virus. However, the complete mechanism by which direct
electric current attenuates HIV-1 infectivity is undoubte dly far re complex than simple
electrolysis. Nonetheless. and independent of a complete understanding of all of the
mechanisms involved in the attenuation of HIV-1 infectivity, the present observations
may serve as an initiaI step for the development of new strategies to treat infection or
prevent transmission of HIV-1 through either treat ing the general blood supply or
developing alternative barrier contraceptive devices. It may also be feasible to treat AIDS
patients with direct electric current using either extracorporeal systems or self contained
indwelling electrodes. Lastly, because viral infectivity is being attenuated, electric current
may render treated HIV-1 suitable for vaccine development.
ACKNOWLEDGMENTS
Thanks go to Mrs. Agnes Geoghan for her excellent secretarial assistance and to
Dr.Gabor, Kemeny for important technical help. Additional thanks go to Drs. Frank Lilly
and Philip Aisen for their constructive criticism of this manuscript.
LEGENDS
21
Figure 1. Results of a representative syncytium-formation assay. Five aliquots of the RF strain of HIV -1
were exposed to direct electric current for up to 8 minutes. Three of the samples were exposed to a total
electric charge of 300.ìA x min (50/6, 75/4 and 100/3). At all the dilutions tested ( shown here), electrical
treatment of the virus aliquots resulted in a significant decrease in syncytium formation.
22
Figure 2. Results of a representative reverse transcriptase assay. Six aliquots o£ the RF strain of HIIV-1
were exposed to different amounts .of current for 3 or 6 minutes. A. significant decrease (p < 0. 005)from 0
current levels (0/3 and 0/6) in reverse transcriptase activity is noted. However, the decrease is more
significant (p<0.0001) when virus is exposed to 100ìA for 6 minutes.
Table 1
Experimental Paradigm
Current (ì.A). Time (Minutes)
0 1 4 8 12
25 2 4 8 12
50 3 4 6 12
75 2 4 8 12
100 1 3 4 12
23
Table 2
Effect of ELECTRIC Current on Syncytium Formationa
% of O Current Control (Ä%)b
Current (ìA) Six Minute Exposure
0100 (0)
50 50 (-50)
100 35 (-65)
a = Value at I:160 dilution of virus.
b = Value equals the mean of 3 experiments.
Table 3
Effect of Electric Current on Reverse
Transcriptase Activitya
% of O Current Control (Ä%)
Current (ìa) Six Minute Exposure
0100 (0)
50 56 (-44)
100 6 (-94)
a = Value equals the mean of 5 experiments.
The standard error of the mean in each case was less than10% of the mean value.
Table 4
Effect of Eclectic Current onViability of Uninfected H9 Cells
(% Viable CeIIsa)
Length of exposure (Minutes), Current (ìA) 0 3 6
24
0 96 94 6
50 98 95 98
100 96 97 93
a = At feast 200 cells counted in hemocytometer field
Table 5
Effect of Electric Current on Temperature of
Tissue Culture Medium a (°C) Length of Exposure (Minutes)
Current (ìA) 0 3 6
0 19 19 19
50 19 19 19
100 19 19 19
a = The temperature was monitored before, during and after exposure.
Results shown are end-point determinations.
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26
27
Appendix 2:
United States Patent 5,188,738 Kaali, et. al. * Feb. 23, 1993
Alternating current supplied electrically conductive method and system for treatment of blood and/or other
body fluids and/or synthetic fluids with electric forces.
Inventors: Kaali; Steven (88 Ashford Ave., Dobbs Ferry, NY 10522); Schwolsky; Peter M. (4101 Cathedral
Ave., NW., Washington, DC 20016).
[*] Notice: The portion of the term of this patent subsequent to Aug. 18, 2009 has been disclaimed.
Appl. No.: 615,437
Filed: Nov. 16, 1990
Related U.S. Application Data
Continuation-in-part of Ser No. 562,721, Aug. 6, 1990, abandoned.
Intl. Cl.: B01D 35//06 A61K 41/00 U.S. Cl.: 210/748; 128/419.R; 128/421; 128/783;
128/784; 204/131; 204/164; 204/186; 204/302; 210/243; 422/ 22; 422/ 44; 604/ 4 Field of
Search: 210/243, 748, 764; 128/419 R, 421, 783, 784; 604/4; 422/22, 44; 204/131, 164,
186, 242, 275, 302, 305
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U.S. Patent Documents 592,735 Oct., 1897 Jones 204/242 672,231 Apr., 1901 Lacomme
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4,473,449 Sept., 1984 Michaels et al. 204/101 4,616,640 Oct., 1986 Kaali et al. 128/130
4,770,167 Sept., 1988 Kaali et al. 128/788 4,932,421 Jun., 1990 Kaali et al. 128/831
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Primary Examiner: Dawson; Robert A. Assistant Examiner: Kim; Sun Uk Attorney, Agent or Firm: Charles W.
Helzer
28
Abstract
A new alternating current process and system for treatment of blood and/or other body fluids and/or
synthetic fluids from a donor to a recipient or storage receptacle or in a recycling system using novel
electrically conductive treatment vessels for treating blood and/or other body fluids and/or synthetic fluids
with electric field forces of appropriate electric field strength to provide electric current flow through the blood
or other body fluids at a magnitude that is biologically compatible but is sufficient to render the bacteria,
virus, parasites and/or fungus ineffective to infect or affect normally healthy cells while maintaining the
biological usefulness of the blood or other fluids. For this purpose low voltage alternating current electric
potentials are applied to the treatment vessel which are of the order of from about 0.2 to 12 volts and
produce current flow densities in the blood or other fluids of from one microampere per square millimeter of
electrode area exposed to the fluid being treated to about two milliamperes per square millimeter.
31 Claims, 26 Drawing Figures
This invention relates to novel electrically conductive methods and systems employing electrically
conductive vessels provided with electrically conductive surfaces for use in subjecting blood and/or other
body fluids and/or synthetic fluids such as tissue culture medium to direct treatment by alternating current
electric forces.
BACKGROUND PROBLEM
It is now well known in the medical profession and the general public that blood collected in a blood bank
from a large number of donors may be contaminated by contaminants such as bacteria, virus, parasites
and/or fungus obtained from even a single donor. While screening of donors has done much to alleviate this
problem, the screening of donors can and does miss occasional donors whose blood is unfit for use. When
this occurs and the unfit blood is mixed with otherwise usable blood, the entire batch must be discarded for
transfusion purposes. Because of this problem, the present invention has been devised to attenuate any
bacteria, virus (including the AIDS HIV virus) parasites and/or fungus contained in blood contributed by a
donor to the point that any such contaminant is rendered ineffective for infecting a normally healthy human
cell, but does not make the blood biologically unfit for use in humans. Similar problems exist with respect to
treatment of other body fluids, such as amniotic fluids. The treatment method and system is also applicable
to mammals other than humans.
In addition to the above, there is a need for methods and systems for the treatment of blood and other body
fluids both in in-situ processing wherein the treated blood and/or other body fluids are withdrawn from the
body, treated and then returned to the body in a closed loop, recirculating treatment process that is located
near but outside the patient's body, or the treatment can be effected through implanted treatment system
components.
In co-pending United States application serial No. 07/615,800 entitled "Electrically Conductive Methods and
Systems for Treatment of Blood and Other Body Fluids with Electric Forces"-Steven Kaali and Peter M.
Schwolsky, inventors, filed concurrently and co-pending with this application, a similar treatment method and
system employing direct current excitation potentials is described and claimed. The disclosure of co-pending
application Ser. No. 07/615,800 hereby is incorporated into this application in its entirety.
SUMMARY OF INVENTION
The present invention provides new electrically conductive methods and systems using alternating electric
current excitation potentials for treating blood and/or other body fluids, such as amniotic fluids, and/or
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synthetic fluids such as tissue culture medium from a donor to a transfusion recipient or to a storage
receptacle, or for re-circulating a single donor's or patient's blood or other body fluids. The treatment can be
accomplished in a treatment system external of the body or by implant devices for purging contaminants
using a novel electrically conductive vessel for direct electric treatment of blood or other body fluids, such as
amniotic fluids, with alternating current electric field forces of appropriate electric field strength to attenuate
such contaminants to the extent that bacteria, virus, fungus, and/or parasites contained in the blood or other
body fluids are rendered ineffective to infect and/or affect normally healthy human cells. The treatment,
however, does not render the blood or other body fluids biologically unfit for use in humans or other
mammals after the treatment. The new methods and systems according to the invention achieve these ends
without requiring time consuming and expensive processing procedures and equipment in addition to those
normally required in the handling of blood or other body fluids or synthetic fluids. The invention can be used
to achieve the electric field force treatment during the normally occurring transfer processing from a donor to
a recipient or to a collection receptacle, or recirculation of a single donor's or patient's blood or other body
fluids, such as amniotic fluids.
BEST MODE OF PRACTICING INVENTION
FIG. 1 is a schematic illustration of one form of a novel blood and other body fluid treatment system
according to the invention. FIG. 1 shows an electrically conductive blood and/or other body fluid treatment
vessel constructed according to the invention which is in the form of intravenous tubing 11 interconnected
between a hypodermic needle 12 and a blood storage receptacle 14. The needle 12 is inserted in an artery
or vein of the arm 13 of a blood donor and the tubing 11 leads from the arm 13 to the receptacle 14.
Alternatively, the system could be set up to transfer blood from the storage receptacle 14 to the arm of a
recipient or could be designed to recirculate the blood through electrified tubing 11 back to the donor. The
electrically conductive tubing 11 may be of any desired length as indicated by the break at 15 so that it can
be appropriately set up to lead from a comfortable position for the donor from whose arm 13 the blood is
being taken to a proper storage location for the receptacle 14. The greater the length of the electrified
portion of tubing 11, then the more extended is the exposure of the blood (or other body fluid) to the electric
field force effects and low level, biologically compatible current flow through the body fluid being treated
thereby assuring adequate electrification treatment of the fluid without impairing the biological usefulness of
the blood or other body fluid being treated.
FIG. 2 is a cross sectional view of the electrically conductive tubing 11 taken through plane 2--2 of FIG. 1.
The tubing 11 may be from 1 to about 20 millimeters in inside diameter, although it may be larger or smaller
in diameter depending upon the intended application. For example, if the blood transfer system is for the
purpose shown in FIG. 6, then the tubing may have a cross sectional dimension of about 5 millimeters.
However, if the intended use is in an implanted blood treatment system, such as shown in FIG. 8, then the
tubing diameter must be designed to result in a flow-through rate corresponding to the natural circulatory
blood flow rate of the patient in which the system is implanted, and must be long enough to assure effective
electrification treatment at the flow rate selected. The tubing 11 is formed from plastic, rubber, medical grade
polymer, or other suitable material which is compatible with human fluids and/or tissue. A plurality of
physically separated, electrically conductive surface segments form opposed, parallel electrodes shown at
16 and 16A on the inside of tubing 11 from electrically conductive materials such as platinum, platinum
alloys, silver, silver or platinum covered alloys, or other similar conductive materials such as conductive
polymers, or silver or platinum covered polymers which are compatible with human fluids and tissue. The
spacing between opposed electrodes 16 and 16A is of the order of 1 to 19 millimeters and perhaps may be
more or less dependent upon the application and the conductivity of the body fluids being treated.
FIG. 3 is a longitudinally extending sectional view along the axis of tubing 11 taken through staggered
section lines 3--3 of FIG. 2. From FIG. 3 of the drawings it will be seen that the electrically conductive
surface segments 16 and 16A all comprise longitudinally extending, zebra-like stripe or strip electrodes
which extend longitudinally in parallel with the longitudinal axis of the tubing 11. In between each
longitudinally extending conductive stripe electrode 16 or 16A is a longitudinally extending electric insulating
area 17 which electrically isolates the alternate electrically conductive, zebra-like stripe electrodes 16 and
16A one from the other.
As best shown in FIG. 3, a first set of alternate electrically conductive surface stripes 16 are electrically
connected in common to a first annular terminal buss 18 which circumferentially surrounds the tubing 11 and
30
is embedded within the sidewalls of the tubing 11 at a suitable point along its length. The design is such that
the first annular terminal buss 18 is electrically isolated from the remaining second set of alternate,
electrically conductive surface stripe electrodes 16A and is electrically connected through a conductor
terminal 19 to an alternating current source of electric excitation potential. AC source 20 may comprise the
output from an AC to AC voltage converter for converting 110 volt AC potential to the desired 0.2 volts to 12
volts for use in the invention. For those treatment systems which are to be implanted as described hereafter,
the AC source may comprise a miniaturized DC to AC converter for converting the DC voltage from a
miniaturized battery to low voltage (0.2 to 12 volts) AC. As best depicted in FIG. 2, all of the first set of
positive electrically conductive stripes 16 are physically and electrically connected in common to the first
annular terminal buss 18 so that all of the conductive stripes 16 are maintained at a constant, alternating
current electric excitation potential.
A second annular terminal buss 21, which circumferentially surrounds the tubing 11, is embedded within the
tubing 11 at a point along its length displaced from the position of the first annular terminal buss 18 and is
spaced inwardly towards the inside diameter of the tubing relative to the first annular buss 18. By this
arrangement it is possible to electrically connect the remaining second set of alternate electrically conductive
surface stripes 16A in common to the second annular terminal buss 21 in a manner such that the second
annular terminal buss is electrically isolated from the first annular terminal buss 18 as well as the first set of
alternate electrically conductive surface stripes 16. As shown in FIG. 3, the second annular terminal buss 21
is provided with an outside terminal conductor connection 22 for connecting the annular buss 21 and annular
buss 18 across AC source 20 as shown in the system drawing of FIG. 1. The second set of alternate
electrically conductive surface stripes 16A are all provided with internal connector studs which physically
and electrically connect all of the 16A stripes in common to the second annular terminal buss 21 so that all
of these conductive stripes will be maintained at a potential opposite to that from the potential applied to the
first set of electrically conductive stripes 16 by annular buss 18.
As described earlier, the AC source of electric potential 20 may constitute an AC to AC converter for
converting 110 volt AC to 0.2 to 12 volt AC or a DC to AC converter for converting 12 volt DC to 0.2 to 12
volt AC. The AC source 20 is connected to the conductor terminals 19 and 22 through electric supply
conductors 23 and 24 preferably by a double pole, double throw, on-off control switch 25. In preferred
embodiments of the invention, voltage controlling variable resistors 26 and 27 also are included in the
electric supply conductors 23 and 24 in order to control the value of the excitation voltage developed
between the alternate sets of conductive surface stripes 16, 16A.
In operation, the donor whose blood is to be taken, or the recipient who is to be given blood, or is to have his
or her blood recycled, is made comfortable on a cot with his or her arm 13 extended and the interconnecting
electrically conductive tubing 11 having the hypodermic needle 12 for withdrawal, or supplying, or recycling
of blood set up as shown in FIG. 1. When both the donor/recipient and the system is in readiness, the
control switch 25 is closed so that an electric field is built up across the oppositely disposed electrically
conductive zebra-like stripes 16, 16A, etc. Voltages of the order of from 0.2 to 12 volts are applied to the
conductive surfaces 16, 16A For this purpose it is important to note that the hypodermic needle should be
electrically isolated via conventional electrically insulating IV tubing from any of the zebra stripe electrodes
16, 16A so that the donor/recipient does not receive a shock. By this precaution, he or she will not even be
aware of the existence of the electric field within the electrically conductive tubing 11. With the treatment
system thus conditioned, the hypodermic needle is inserted into a vein in the donor's/recipient's arm and
blood is withdrawn, given, or recycled through the tubing 11.
As the blood passes through the electric fields produced within the electric conductive tubing 11 it will be
subjected to and treated by biologically compatible electric current flow through the blood or other body fluid
with a current density of from one microampere per square millimeter (1 muA/mm(^2)) of electrode cross
sectional area exposed to the fluid to about two milliamperes per square millimeter (2 mA/mm(^2))
dependent upon field strength of the electric field gradient existing between electrodes 16 and 16A, the
space between the electrodes 16, 16A and the conductivity (resistivity) of the body fluid being treated.
Recent experiments have proven that exposure to electric fields induced by supply voltages in the range
produces electric current flow through blood of the order of 1 to 100 microamperes. Effectiveness is
dependent upon length of time of treatment in conjunction with the magnitude of the biologically compatible
current flow. For example, treatment of virus in media at 100 microamperes for 3 minutes has been
observed to substantially attenuate (render ineffective) the AIDS virus. Similar treatment at other field
strength values and lengths of time will have a similar attenuating effect on bacteria, virus, parasites and/or
fungus which are present in blood or other body fluids being treated. By controlling the length of time and
field strength values that blood is subjected to the electric field forces, undesirable contaminants such as
31
virus, bacteria, fungus and/or parasites will be adequately attenuated to the point that they are rendered
ineffective by the sustained action of the electric current flow as the blood travels from the hypodermic
needle 12 to the storage bag 14, or vice versa, or in a recycling mode. The length of travel of the blood
through the sustained electric field induced current flow also can be adjusted so that the blood is subjected
to the electric field force for time periods of the order of from one to six minutes at least. At the current
values noted above this is believed adequate to attenuate (render ineffective) bacteria, virus (including the
AIDS virus), parasites and/or fungus entrained in blood or other body fluids, but does not render the fluids
unfit for human use or impair their biological usefulness.
The species of the invention shown in FIGS. 2 and 3 is advantageous since it is possible to fabricate the
treatment tubing by preforming the conductive segments 16 and 16A on the tubing walls while it is in a flat
planar condition, and then rolling the walls into tubular form using a suitable mandrel. The adjoining
longitudinal edges of the planar member after rolling are thereafter heat sealed along a longitudinally
extending seam located within one of the electrically insulating sections 17. Particular attention must be paid
to the juncture of the ends of the annular terminal busses 18 and 21 during the rolling and heat sealing steps
to assure that good electrical interconnection and continuity at these junctures of the annular terminal
busses is provided in the completed treatment tubing. The conductive electrode segments 16, 16A may be
electro-deposited, chemically formed, separately formed conductive polymer surfaces, or conductive foil or
wires adhesively secured to the side walls of the tubing 11 in advance of the rolling and sealing using
techniques well known in the printed circuit and integrated circuit manufacturing technologies.
FIG. 6 is a diagrammatic, fragmentary, elevational view of a modified blood treatment system using the
novel electrically conductive treatment tubing in accordance with the invention. In the FIG. 6 embodiment of
the invention, a blood pump 28 of conventional, commercially available construction is inserted in the tubing
11 at some point along its length. The blood pump 28 is electrically isolated from the zebra striped
conductive surfaces 16, 16A by suitable insulators 29 formed on the blood input-output connections of pump
28. Provision for electrically bypassing the blood pump 28 (if need be) is made through the shunt conductors
30, 30A which maintain electrical continuity of the alternating current excitation potential applied to the
conductive stripes 16, 16A on each side of pump 28. For convenience, the alternating current excitation
source 20 and its connection to the electrically conductive tubing 11 has not been shown in FIG. 6 but would
have to be provided. A separate source of excitation current for running the blood pump 28 is provided from
a conventional 110 volt alternating current source through the input terminals 31, 31A.
In systems employing a blood pump, it may be desirable in some applications to provide a blood flow
regulating valve 37 inserted in the system at the output of blood pump 28 and within the by-pass loop 30,
30A for the conductive stripes 16, 16A. By thus controlling blood flow, the electrified transfer system safely
can be employed in a closed loop recycling system for withdrawing blood from a patient, electrically treating
the blood as described above and then returning the electrically treated blood to the patient. This procedure
is referred to herein as recycling. The system of FIG. 6 also can be used in those situations where the blood
flow of a donor's blood is not sufficient to assure supply of an adequate amount of blood to or from the
collection receptacle 14 or other recipient. It may also be desirable to have a blood flow regulating valve
such as 37 in non-pump systems.
FIGS. 4 and 5 of the drawings show another embodiment of the invention wherein the electrically conductive
treatment tubing 11 includes electrically conductive electrode segments 32 and 32A which are in the form of
zebra stripes that extend radially around the inside diameter of tubing 11 in spaced-apart, alternating
polarity, conductive annular bands 32 and 32A separated by insulating surface bands 11I which serve to
electrically isolate the respective first set of conductive zebra stripes 32 from the second set of conductive
zebra stripes 32A. The first set of alternate ones of the electrically conductive annular stripes 32 are
electrically connected in common to a first longitudinally extending terminal buss bar 33 that is embedded
within tubing 11 in parallel with the longitudinal axis of the tubing and electrically isolated from the remaining
second set of alternate electrically conductive annular stripes 32A. The first longitudinally extending terminal
buss bar 33 is designed for connection to one output terminal of a source, such as 20, of alternating current
electric excitation potential through a supply conductor connection 35 on the exterior surface of the tubing
11.
A second longitudinally extending terminal buss bar 34 is embedded within the body of tubing 11 and is
electrically connected to the remaining second set of alternate electrically conductive annular stripes 32A.
The second longitudinally extending terminal buss bar 34 is electrically isolated from the first longitudinally
extending terminal buss 33 and the first set of alternate electrically annular stripes 32. Terminal buss bar 33
32
is designed for connection to a second output terminal for the alternating current source of electric excitation
potential. For this purpose an input supply conductor connection 36 is directly connected through the
exterior surface of tubing 11 and to the second longitudinally treatment extending terminal buss bar 34.
In operation, the embodiment of the invention shown in FIGS. 4 and 5 is physically arranged in a blood
treatment system in the manner illustrated in FIG. 1 of the drawings with the positive polarity and negative
polarity zebra annular stripes being connected to the respective output terminals of AC source 20 via control
switch 25. If required, a blood pump such as 28 and blood flow regulating valve 37 shown in FIG. 6 can be
included in the blood transfer system employing electrified tubing as shown in FIGS. 4 and 5.
Similar to the system shown in FIG. 1, a blood transfer system employing the embodiment of the invention
shown in FIGS. 4 and 5 would be electrically excited in advance of injection of the hypodermic needle 12
into the arm of a blood donor so that all blood passing through the tubing 11 will be subjected to electric
forces produced between the alternate polarity annularly formed conductive bands 32 and 32A. Experience
with the invention will establish what length is required for the electrification field. However, for initial
installations the length of the electrified field as related to the flow of blood through electrified tubing 11
should correspond to at least the 1-6 minute treatment time mentioned earlier. This is achieved by using an
extended array of the alternate annular zebra bands 32 and 32A of adequate length to assure thorough
subjection of blood to electric current flow produced between the alternating polarity zebra stripes 32 and
32A. The electric field force intensity applied to the blood by means of the electrified tubing is anticipated to
be of the order of from 0.2 to 12 volts similar to the embodiment of the invention shown in FIGS. 1-3.
In place of supplying continuous alternating current excitation to the conductive stripes 16, 16A of FIGS. 2
and 3 or 32, 32A of FIGS. 4 and 5, it also is possible to excite these electrically conductive segments of
tubing 11 with pulsed waveform direct current excitation potentials. For use in this manner, the pulse rate of
the pulsed waveform excitation potentials must be sufficiently high to maintain continuous current flow
through blood being treated. In addition, it may be desirable to couple a bank of storage capacitors in
parallel across respective pairs of opposite polarity electrically conductive segments 16, 16A and 32, 32A
where operation in a pulsed DC mode is desired.
FIG. 7 of the drawings is a cross sectional view of another embodiment of the invention which is
substantially different from those previously described. In FIG. 7, the material used for fabrication of the
tubing 11 is one of the new space-age polymer materials which can be either highly electrically conductive,
insulating, or semiconducting and may have values of conductivity ranging from essentially fully conductive
to insulating. In the embodiment of the invention of FIG. 7, the conductive surface areas on the inside
diameter of the tubing 11 are actually formed into segments, such as 11C, of the cross sectional area of the
tubing 11 fabricated from the highly conductive polymer material. The intervening segments of the tubing 11I
which separate the conductive segments 11C are integrally formed from the highly insulating polymer
material. Suitable positive polarity and negative polarity potentials are applied to the exterior surface areas
of alternate ones of the sets of conductive polymer segments 11C from a source of electric potential via the
conductors 23 and 24 as illustrated schematically in FIG. 7.
It will be appreciated that the embodiment of the invention shown in FIG. 7 is much simpler and hence less
expensive to make in that it requires fewer processing steps than the embodiments of the invention shown in
FIGS. 1-6. In other respects, the embodiment of the invention shown in FIG. 7 would be used in a blood
transfer system similar to that shown in FIG. 1 or 6 with or without a blood pump 28 and blood flow
regulating valve 37 to effect transfer of blood from a donor to a receptacle or recipient in the event of a
transfusion or recycling. During the blood transfer process, again it would be necessary to provide
alternating current excitation potentials across the spaced-apart, alternate sets of electrically conductive
polymer segments 11C prior to passing blood through the tubing 11. This will assure that all of the blood
being transferred is subjected to the electric field forces produced between the alternate conductive surfaces
11C. As a variation of the FIG. 7 embodiment, which visualizes that the segments 11C and 11I all extend
longitudinally and parallel to the longitudinal axis of tubing 11, it would be possible, but more elaborate to
design, to employ alternate radially surrounding annular conductive segments 11C and interlacing insulating
segments 11I similar to FIG. 5, but such fabrication would require somewhat more complex terminal buss
bar electric supply connections 23 and 24 than those shown in FIG. 7.
FIG. 8 is a fragmentary, diagrammatic, elevational view showing a form of blood treatment system according
to the invention wherein a small electrically conductive vessel 41 in the form of a short piece of electrified
tubing and a combined miniaturized DC to AC converter and battery power source 42 are implanted in the
33
arm of a human being. The electrified tubing 41 may be in the form of any of the prior disclosed electrified
tubing structures described with relation to FIGS. 1-7, but which are fabricated in miniaturized form so that
the tubing 41 and power package 42 can be inserted in a section of or surrounding a vein 44 of the arm 13
of a patient whose blood is being treated. The implantation is such that the blood through the patient's vein
44 naturally is pumped through the short piece of electrified tubing 41 while circulating blood to the hand of
the patient to thereby form a closed loop, recirculating, implanted treatment system that comprises an
integral part of the circulatory system of the patient being treated. Because the parameters of such an
implanted system are necessarily small, a single passage through the implanted electrified tube 14 may
accomplish relatively little attenuation of contaminants in the blood. Therefore, it is the repeated passage of
small portions of the patient's blood continuously twenty-four hours a day and for as many days as are
needed which will gradually attenuate the contaminants to the point where they are rendered ineffective as
described earlier.
FIG. 9 is a partial, fragmentary, sectional view of the upper arm portion 13 of a vein or artery of a patient in
which a treatment system according to the invention has been implanted, and shows in greater detail the
construction of a specialized, miniaturized, electrically conductive treatment vessel with associated
miniaturized battery electric power source and DC to AC converter for use in an implanted treatment system
as shown in FIG. 8. In FIG. 9, the electrified vessel 41 is in the form of an outer housing 45 that is in the
shape of a football which is implanted within the interior walls 44 of an artery or a vein. The outer housing 45
is comprised by a central, cylindrically-shaped portion 45M of solid conductor such as platinum which is
biocompatible with human blood and tissue and has integrally formed, conically-shaped porous ends 45C
which are attached to and form an electrically conductive screen grid (at the same potential) as the mid
portion 45M. The conical end portions 45C both are perforated and may be in the nature of a screen or
mesh wire and of the same material composition as the mid portion 45M. Disposed within the outer housing
45 is a inner housing 46 which is tear-drop shaped and secured within the central portion 45M of the outer
housing by suitable insulating support spider legs 47. The inner housing 46 likewise is formed from platinum
or other suitable biocompatible conductive material and has supported within its interior a miniaturized AC
source comprising a miniaturized battery and AC to DC converter 42 secured to the conductive walls of
inner housing 46 by conductive support legs 48. The support legs 48 serve as terminal connectors from one
terminal of AC power converter 42 to the inner housing 46 so that it is maintained at one polarity excitation
potential. The remaining opposite polarity terminal of miniaturized AC source 42 is connected through an
insulated conductor 49 to the central portion 45M of outer housing 45 whereby the entire outer housing
including the meshed conical end portions 45C are maintained at an opposite polarity potential from the
inner housing 46.
Prior to implantation in a patient, the electrified vessel shown in FIG. 9 is activated by connection to AC
source 42 so that an electric field gradient is produced across the space between the inner and outer
housings 45 and 46. Following implantation of the activated, electrified treatment vessel 41, its presence in a
vein or artery will cause all blood flowing through the vein or artery to pass between the side walls of the
inner and outer housings 45 and 46 so as to be subjected to the electric field force gradient existing in these
spaces. The presence of the electric field forces will induce a current flow through the blood passing
between the interior and outer housings as explained above which will result in attenuating bacteria, virus,
parasites and/or fungus which are present in the blood as contaminants. Here again, because of the
relatively small portion of the total blood flowing in a patient that will be treated by the device within a given
time period, it is the repeated, recycling process treatment of the blood over a prolonged period of time that
will result in attenuation of the contaminants in the blood to the point where such contaminants are rendered
ineffective as described earlier.
In order to further assure adequate treatment of the blood of a patient receiving the implant device, it is
recommended that the blood be treated in an external treatment processing facility such as described earlier
in FIGS. 1 and 6 or to be described hereinafter with relation to FIGS. 18 and 19 in which the total capacity of
the treatment system is greater whereby substantial attenuation effect can be achieved in a comparatively
shorter time period yet to be determined, and then the in vitro implant treatment system such as shown in
FIGS. 8, 9 and 10 can be used to maintain the attenuated condition and to prevent any subsequent build up
of contaminants after the initial treatment, if determined to be desirable.
FIG. 10 is a fragmentary, diagrammatic view of a partial vein or artery 44 showing in greater detail the
cylindrical or tubular electrified treatment vessel 41 originally described with relation to FIG. 8. This implant
treatment vessel 41 is miniaturized so that it is in effect an open-ended cylinder in shape and has a diameter
comparable to that of a large vein or artery and so that it can be grafted or implanted into the vein or artery
as illustrated in FIG. 10. The tubular treatment vessel 41 may be designed pursuant to FIGS. 2 and 3 of the
34
drawings, for example. For this application, the battery source of power and interconnected DC to AC
converter 42 are annular in shape and are slipped over the tubular treatment vessel 41 in the manner
shown. In FIG. 10 a longitudinal sectional view of the hollow annular-shaped treatment vessel 41 and AC
power source 42 is illustrated. At the point where the battery driven AC power source 42 fits over the tubular
treatment vessel 41, the respective terminals of the AC power source 42 are exposed to engage the
corresponding positive and negative supply terminals 19 and 22 of the tube 41 so that the resulting structure
has a minimum exterior profile to facilitate implantation. From a comparison of FIG. 10 to FIG. 9 of the
drawings, it will be appreciated that the FIG. 9 treatment vessel introduces some flow restriction in the vein
or artery in which it is implanted and for this reason the construction shown in FIG. 10 is preferred.
FIGS. 11 and 11A of the drawings illustrate a construction for the electrified treatment vessel 51 wherein the
treatment vessel is in the form of square or rectangular cross sectionally-shaped open-ended tubing. The
treatment tubing 51 provided with a square or rectangular shape so that provision of opposed, parallel
conductive electrode surfaces 51U and 51L is greatly simplified as best seen in FIG. 11A of the drawings,
which is a cross sectional view taken through plane 11A--11A of FIG. 11. By fabricating the upper and lower
surfaces of the tubing 11 from electrically conductive material such as platinum, etc., and separating the
upper and lower surfaces 51U and 51L by electrically insulating side walls 52R and 52L, provision of the
electrically isolated, opposed, parallel electrode surfaces is simplified and the resulting treatment vessel
introduces minimum restriction to flow of blood. By connecting the upper surface 51U to one terminal of the
AC power source 42 and connecting the lower surface 51L to the opposite terminal, AC electrification of the
interior area of the tubing wherein the fluids to be treated flow is readily achieved with a greatly simplified
electrode structure. Variations of this structural feature wherein the side insulating surfaces 52R and 52L are
curved with their concave surfaces facing each other and the cross sectional area of the upper and lower
conductive surfaces 51U and 51L tailored to provide a desired current density, tubular treatment vessels
such as shown in FIGS. 11 and 11A could be readily provided for use in implantation devices such as that
illustrated in FIG. 8.
FIG. 12 is a perspective view of a novel, electrified, closed, octagonally-shaped, flat, box-like treatment
vessel 60 according to the invention which provides an enlarged cross-sectional area relative to the cross
sectional diameter of the inlet and outlet tubing supplying the interior of the treatment vessel whereby
increased through-put of a fluid being treated can be achieved in a given time period. The treatment vessel
60 shown in FIG. 12 is comprised essentially of upper and lower, octagonally-shaped, flat insulating plates
61 and 62, respectively, of an insulating material which is compatible with human blood and/or other body
fluids. Disposed immediately below and above the upper and lower plates 61 and 62 are octagonally-
shaped, conductive electrode members 63 and 64, respectively, which are separated and electrically
isolated one from the other by a surrounding electric insulating gasket member 65. The entire structure is
sandwiched together and held in assembled relation by threaded thru-pins 66 as best seen in FIG. 12A of
the drawings. The insulating gasket 65 which may be of teflon defines an open space 67 between the two
conductive electrode members 63 and 64 into which the blood or other body fluid to be treated is introduced
via inlet and outlet conduits 68 and 69. Alternating current electric potentials are applied across the
respective conductive plates 63 and 64 to produce an electric field force across the intermediate space 67
through which the fluids being treated flow between electrode plates 63 and 64. By thus structuring the
treatment vessel, increased treatment surface area is provided to the blood or other body fluid flowing
through the space 67 whereby in a given time period an increased quantity of fluids can be treated.
FIG. 13 is a perspective view of another form of enlarged cross sectional area treatment vessel 70 having an
exterior shape similar to that of the treatment vessel shown in FIG. 12. The electrified treatment vessel
shown in FIG. 13 differs from that in FIG. 12, however, in the construction of its electrically conductive
electrodes which comprise a plurality of interleaved, conductive, flat, electrode plates 71 and 71A. The
electrode plates 71 are secured in and project inwardly from a right hand (RH) conductive end plate 73R as
shown in FIG. 13A. The alternate set of flat electrode plates 71A are secured to and project inwardly from a
corresponding conductive end plate 73L on the left hand end of the treatment vessel 70. The conductive end
plates 73R and 73L and coacting insulating side plates 72 which insulate the conducting end plates from
one another, form an octagonally-shaped box frame which is closed by upper and lower insulating top and
bottom insulating plates 74 and 75. The conductive end plates 73R and 73L have a central opening formed
therein into which inlet and outlet tubes 76 and 77 are secured as best seen in FIG. 13 for providing inlet
and outlet flow through connection to the treatment vessel 70.
The alternate sets of flat electrode plates 71 and 71A extend parallel to one another and are provided with
alternating current electric potentials supplied across the respective sets of interleaved electrode plates via
the respective conductive end members 73R and 73L. If desired, the respective flat conductive electrode
35
plates 71 and 71A may be fabricated from a perforated material as shown in FIG. 13B of the drawings. Also,
it may be desirable that some form of thermal insulation, or a thermally controlled chamber be provided
around the exterior of the treatment vessel 70 as indicated by the thermal insulation 78 shown in FIG. 13A.
In operation, electrified treatment vessel 70 shown in FIGS. 13, 13A and 13B functions in essentially the
same manner as was described earlier with respect to FIGS. 1-7 to effect attenuation of contaminants such
as bacteria, virus and fungus contained in blood and/or other body fluids being treated in the flow through
treatment vessel of FIG. 13.
FIG. 14 is a longitudinal sectional view of still another form of enlarged cross sectional area, electrified
treatment vessel 80. The treatment vessel 80 shown in FIG. 14 is in the form of an open-ended, elongated
cylinder 81 whose cylindrical walls are fabricated from an insulating material which is biocompatible with
human blood and/or other body fluids and whose open ends are closed by circular-shaped conductive end
pieces 82 and 83. Inlet and outlet tubular openings 84 and 85 are provided to the interior of cylindrical
housing 81 through centrally formed apertures in the circular and plates 82 and 83. Within the interior of the
cylindrical, insulating housing 81 at least two, separate, concentric, perforated, cylindrically-shaped
electrode members 86 and 87 are provided which extend longitudinally through the interior of the outer
cylindrical housing 81. The first set of concentric, perforated, electrically conductive electrodes 86 is
embedded in and supported by the conductive end plate 82 which serves as an electrical terminal for
applying electric potentials to all of the concentric electrode member 86. Similarly, the concentric, perforated,
conductive electrode member 87 is physically supported by and electrically connected to the conductive end
plate 83 for the supply of alternating current potentials there across. Additionally, if desired, one or more
additional perforated concentric electrode members similar to 86 may be spaced apart from the inner
concentric electrode member 86 outwardly along the diameter of the circular end member 82 with additional
perforated concentric electrode members 87 being sandwiched between the two electrode members 86 and
spaced apart there from so as to provide an electric field force between all the spaced apart, separated
electrically conductive electrode members 86 and 87. Additionally, if desired, a conductive surface 89 may
be formed around the interior walls of the outer, insulating cylindrical housing member 81 and electrically
connected to the conductive end plate 82 or 83. This will assure that the entire interior of the treatment 80
vessel cross sectional area is crossed by the electric field force and all blood or other body fluid passing the
cylindrical housing member 81 is subjected to biologically compatible low electric current flow as a
consequence of the alternating current electric fields produced between the different concentric electrode
members including the coated surface 89 within the interior insulating housing member 81.
In operation, the embodiment of the invention shown in FIG. 14 and 14A operates in substantially the same
manner as described with relation to earlier embodiments of the invention to assure production of
biologically compatible electric current flow through the blood or other body fluid being treated in the
treatment vessel 80.
FIG. 15 is a longitudinal sectional view of still another embodiment of an enlarged cross-sectional area
treatment vessel 90. The treatment vessel 90 again comprises an outer, hollow, open-ended cylindrically-
shaped, insulating body member 91 whose open ends are closed by electrically conductive, circular end
plates 92 and 93, respectively. Inlet and outlet tubular openings 94 and 95 are provided through the central
axial opening in the conductive end plates 92 and 93 for passage of blood and/or other body fluids being
treated into the interior of the treatment vessel 90. The conductive end plates 92 and 93 have respective
sets of opposite polarity potential needle-like electrodes 96 and 97, respectively, projecting there from
inwardly into the interior of the treatment vessel 90. Alternating current electric potentials are applied to the
respective conductive end plates 92 and 93 through respective AC supply terminals indicated at 98 and 99.
If desired, and in order to assure complete saturation of the entire volumetric area within treatment vessel 90
with electric fields, a conductive coating similar to that shown at 89 in FIG. 14 can be provided to the inner
surface of the hollow, cylindrically-shaped outer body member 91 of treatment vessel 90.
FIG. 15A is a cross sectional view taken through plane A-A of FIG. 15 and shows how the array of needle-
like electrodes appear within the interior of the treatment vessel 90. In operation, the treatment vessel 90 will
function in substantially the same manner as has been described previously wit relation to earlier described
embodiments of the invention.
FIG. 16 is a perspective view of still another form of enlarged cross sectional area treatment vessel 100
according to the invention and FIG. 16A is a partial cross sectional view taken through plane 16A--16A of
FIG. 16. The treatment vessel 100 comprises a relatively large rectangular-shaped block 101 of electrical
36
insulating material which is biocompatible with blood and/or other human body fluids. The insulating block
101 has a plurality of parallel, longitudinally extending, open-ended, tubular-shaped openings 102 formed
therein through the entire length of the block. The tubes 102 are provided with electrically isolated, opposed,
parallel extending conductive plate electrodes 109 as best shown in FIG. 16A, which have alternating
current electric potentials applied there across. One set of these electrodes, formed for example by the
lower electrode 109 in each tube, extend out to and engage a conductive surface coating formed on one end
of the insulating block, for example 101R, and the remaining upper electrodes 109 form a second set which
extend out of the left hand end of the tubes and contact a conductive coating formed on the remaining end
101L of block 101. Alternating current electric potentials are connected across the respective conductive
surfaces 101R and 101L so that a potential difference exists between the sets of electrodes 109 within each
longitudinally extending tube in block 101. The ends of the tubes 102 open into and are supplied from, or
supply, respective header reservoirs 103 and 104 formed on the respective opposite ends of the block of
insulating material 101. Each of the reservoirs 103 and 104 has a centrally formed opening for receiving
either an inlet tube 105 applied to header 103 or an outlet tube 106 secured to header 104 for supply of
blood or other body fluids to be treated to and from the treatment vessel 100. If desired, a blood pump or
other fluid pump can be inserted between the supply tube 105 and header 103, or between outlet tube 106
and the or outlet from the header reservoir 104, or both. Alternatively, both inlet and outlet pumps can be
used. In operation, the electrified treatment vessel 100 shown in FIG. 16 functions in the same manner as
those species of treatment vessels described previously.
For some treatment applications, it may be desirable to provide exhaust vents such as shown at 107 and
108 in FIG. 16 to the inlet reservoir 103 and/or the outlet reservoir 104 with the vents that can be selectively
operated by valves that can be automatically or manually controlled for venting off gases that might be
trapped in the tops of reservoirs and which otherwise might interfere with the proper operation of the
electrified treatment vessel. In a similar manner, suitable venting apparatus may be provided to other of the
large cross sectional area electrified treatment vessels described previously.
FIG. 17 is a perspective view of still another enlarged cross-sectional area treatment vessel 110 which is
similar in all respects to the treatment vessel shown in FIG. 16 with the exception that the body or block of
insulating material 101 through which the elongate tubular openings are made, is cylindrically shaped as
illustrated in FIG. 17. In other respects, the embodiment of the invention shown in FIG. 17 would be identical
to FIG. 16 in the fabrication and operation of its component parts including the reservoir headers 103 and
104 and would operate in a similar manner.
FIG. 18 is a diagrammatic, sketch of a human blood or other body fluid treatment system employing one of
the larger cross-sectional dimension luid treatment vessels 60, such as any one of those shown in FIGS. 12-
17 of the drawings. The particular fluid treatment system shown in FIG. 18 is for a continuous flow-through
recirculating body fluid treatment wherein blood is withdrawn from the arm 13 of a patient and supplied
through IV tubing 111 to a commercially available blood pump 28 and thence to an electrified treatment
vessel 60. The treatment vessel 60 may be like any of the treatment vessels described with relation to FIGS.
12-17 of the drawings wherein the blood or other body fluid being treated is exposed to a low voltage, low
current electric current flow for attenuating to the point of rendering them ineffective, any contaminants
entrained in the blood, such as bacteria, virus and fungus. The treated blood appearing at the output of the
treatment vessel 60 then is recirculated back through IV tubing 112 to the arm 13 of the patient whose blood
or other body fluid is being treated. If desired, IV tubing 111 and 112 could also be treatment tubing such as
described in FIGS. 1-7 and 11. This could provide double treatment for the fluid if that were desirable. In the
event that the entire treatment does not take place in an air conditioned, temperature controlled room, then it
may be desirable to provide a temperature controlled enclosure indicated by dotted lines 78 around at least
the pump 28, electrified treatment vessel 60 and the interconnecting IV tubing sections 111 and 112 in order
to assure maintaining a substantially constant viscosity of the blood or body fluid being treated.
Normally, the system of FIG. 18 would be used in a continuous flow-through re-circulating treatment system
wherein blood from the patient's arm 13 is supplied through pump 28 to the treatment vessel 60 where it is
treated and then discharged back through tubing section 112 to the arm of the patient. The flow rate of the
blood thus processed would be adjusted to correspond substantially to the natural flow rate of blood
circulated through the patient's body to the extent possible.
In addition to operation in the above manner, it would also be possible to operate the system of FIG. 18 in a
stopped-flow, batch treatment manner wherein the blood pump is intermittently stopped to allow for more
extended electrical treatment of the blood or other body fluid contained in the treatment vessel 60 during the
37
period of time (referred to as the dwell time) that the blood pump is stopped thereby assuring fuller
electrification treatment and the greater attenuation of the bacteria, virus, parasites and/or fungus entrained
in the blood.
FIG. 19 is a diagrammatic sketch of a form of closed loop, flow-through recirculating treatment system
according to the invention that is somewhat similar to the system shown in FIG. 18. FIG. 19 differs from FIG.
18 in that an inlet pump 28 and an outlet pump 28' are connected to, respectively, the intake to and outlet
from the electrified treatment vessel 60. If desired, an inlet control valve 113 and an outlet control valve 114
also can be interconnected between the inlet pump 28 and the intake to the treatment vessel 60 and
between the output from the treatment vessel 60 and the intake to the outlet blood pump 28'. These inlet and
outlet control valves indicated at 113 and 114 preferably are automatically operated in a time sequence
which allows the system of FIG. 19 to be operated as a two pump, start-stop flow through system. When
operated in this manner, the first pump 28 is allowed to operate and discharge blood from the arm 13 of the
patient to be pumped into the treatment vessel 60 and thereafter is closed off with both the inlet and outlet
valves 113 and 114 in their closed condition. At this point electrification treatment of the blood or other body
fluid takes place for a predetermined, scheduled time period to assure adequate attenuation to the point of
rendering ineffective the contaminant bacteria, virus, parasites or fungus. Upon completion of the pre-
scheduled treatment period, the outlet valve 114 is opened and outlet pump 28' actuated to return the
treated blood to the arm of the patient 13. Operation in this semi-continuous, start-stop, batch fashion will
assure that adequate electrified treatment of the blood has been accomplished while achieving this end in a
somewhat continuous manner suitable for use in a closed loop, recycling blood treatment process.
PRACTICAL USES OF INVENTION
While the disclosure herein presented has been directed to principally the electrical treatment of blood, it is
believed obvious to those skilled in the art that the invention can be applied with corresponding effect to
other body fluids which are electrically conductive for the treatment of contaminants such as bacteria, virus,
parasites and/or fungus contained therein. Further, while voltages of the order of from about 0.2 volts to 12
volts AC have been indicated as preferable, it is possible that certain virus may be attenuated (or attenuated
at a faster rate) if they are subjected to greater electric current magnitudes of the order of 500 microamperes
for shorter time periods. Acceptable current magnitudes normally would require an excitation voltage of from
0.2 to 12 volts. However, in certain cases where faster or more complete attenuation of the contaminants in
body fluids may be desired under certain circumstances and conditions, the excitation voltage supplied to
the conductive tubing may in fact exceed the 0.2 to 12 volt range indicated for most treatments.
Although it is uncertain what is specifically causing the attenuation of the contaminants (virus, bacteria,
parasites and/or fungus), some possible explanations have been put forward. One is that the attenuation is
caused simply by the direct affect of the electric current and voltage. Another entails the following. When a
voltage is applied to the electrodes, a small current will flow through the electrically conductive medium. The
applied voltage and ensuing current will induce changes in the complex biologically active fluid. Current can
flow through the media if positive and/or negative charges are transported through said media. The transport
might induce changes in the charge distribution of the biologically active molecules thus changing their
biological activity. Furthermore, the voltage and current can induce the production or elimination of different
ions, radicals, gases and/or PH levels which may affect, alone or in combination, the biologically active
molecules and/or cells. The above products of the electrical processes may either be very short lived and
stay in the close proximity of the electrodes or can diffuse or mix in the bulk of the media and react with the
biologically active molecules or cells to result in their attenuation.
Having described several embodiments of new and improved electrically conductive treatment methods and
vessels for use in practicing the novel method for the treatment of blood and/or other body fluids with electric
field forces and treatment systems employing the same, it is believed obvious that other modifications and
variations of the invention will be suggested to those skilled in the art in the light of the above teachings. It is
therefore to be understood that changes may be made in the particular embodiments of the invention
described which are within the full intended scope of the invention as defined by the appended claims.
38
Claims
What is claimed is:
1. An electrically conductive vessel for direct electric treatment of bacteria, and/or virus, and/or parasites
and/or fungus entrained in blood and/or other body fluids and/or synthetic fluids contained within or flowing
through the vessel in the presence of electric field forces, said electrically conductive vessel being fabricated
with only biologically compatible material contacting the fluid being treated and with an array of at least two
or more spaced-apart, opposed electrically conductive electrode segments formed of biologically compatible
conductive material on or in the interior surface of the vessel and exposed to blood or other fluids contained
in or flowing through the vessel, said electrically conductive electrode segments being electrically isolated
from each other and extending over or through a portion of the length of the vessel, and means for applying
low voltage alternating current non-biologically damaging electric potentials to the electrically conductive
electrode segments whereby electrical field forces are produced between the electrically conductive
electrode segments that induce biologically compatible current flow through the blood and/or other fluids
contained in or flowing through the vessel so as to attenuate bacteria, virus, parasites and/or fungus
contained in the blood and/or other fluids by the action of the electric current flow therethrough to thereby
render the bacteria, virus, parasites and/or fungus ineffective while not impairing and maintaining the
biological usefulness of the fluids.
2. An electrically conductive vessel according to claim 1 wherein the low voltage alternating current electric
potentials are in the range from about 0.2 volts to 12 volts and induce electric current flow densities in the
blood or other fluids of from one microampere per square millimeter (1 muA/mm(^2)) to about two
milliamperes per square millimeter (2 mA/mm(^2)).
3. An electrically conductive vessel according to claim 2 wherein the vessel is in the form of tubing and is
inserted in a flow-thru blood treatment system between a hypodermic needle employed to withdraw and/or
supply blood from a donor and/or to a recipient and/or a blood storage receptacle or to a patient in a blood
recycling system.
4. An electrically conductive vessel according to claim 2 wherein the vessel is part of a system and is in the
form of tubing and a blood pump is inserted in the tubing between a donor and a recipient or a receptacle,
and the system further includes means for electrically isolating the blood pump from the electrically
conductive vessel, means for regulating blood flow rate from the blood pump output and means for
maintaining electrical continuity throughout a desired length of the conductive vessel.
5. An electrically conductive vessel according to claim 2 wherein the vessel is in the form of tubing and the
electrically conductive electrode segments are in the form zebra stripes which extend longitudinally parallel
with the longitudinal axis of the tubing with the alternate electrically conductive electrode stripes being
separated by alternate electrically insulating stripes for electrically isolating the alternate electrically
conductive electrode stripes one from the other, a first set of alternate ones of the electrically conductive
electrode stripes being electrically connected in common to a first annular terminal buss formed on and
circumferentially surrounding the tubing and electrically isolated from the remaining second set of alternate
electrically conductive electrode stripes, said first annular terminal buss being designed for connection to
one supply terminal of a source of alternating current electric excitation potential, and a second annular
terminal buss circumferentially surrounding the tubing and electrically connected to the remaining second
set of alternate electrically conductive electrode stripes, said second annular terminal buss being electrically
isolated from the first annular terminal buss and the first set of alternate electrically conductive electrode
stripes and being designed for connection to a second supply terminal of a source of alternating current
electric excitation potential.
6. Electrically conductive tubing according to claim 5 wherein the tubing is inserted in a flow-thru blood
treatment system between a hypodermic needle employed to withdraw and/or supply blood from a donor
and/or to a recipient and/or a blood storage receptacle or to a patient in a blood recycling system.
7. Electrically conductive tubing according to claim 5 wherein a blood pump is inserted in the tubing between
a donor and a recipient and/or a receptacle, and the tubing is a part of a system which further includes
means for electrically isolating the blood pump from the electrically conductive tubing, means for regulating
39
blood flow rate from the blood pump output, and means for electrically interconnecting the input and output
sides of the tubing around the blood pump and the blood flow regulating means whereby electrical continuity
is maintained throughout a desired length of the tubing.
8. An electrically conductive tubing according to claim 2 wherein the vessel is in the form of tubing and the
electrically conductive electrode segments are in the form of zebra stripes which extend radially around the
inside diameter of the tubing in alternating conductive and insulating annular bands whereby alternate
conductive bands are electrically isolated one from the other by respective insulating bands, a first set of
alternate ones of the electrically conductive annular electrode stripes being electrically connected in
common to a first longitudinally extending terminal buss that is formed on the tubing in parallel with the
longitudinal axis thereof and electrically isolated from the remaining second set of alternate electrically
conductive annular electrode stripes, said first longitudinally ext ending terminal buss being designed for
connection to a first supply terminal of a source of alternating current electric excitation potential, and a
second longitudinally extending terminal buss electrically connected to the remaining second set of alternate
electrically conductive annular electrode stripes, said second longitudinally extending terminal buss being
electrically isolated from the first longitudinally extending terminal buss and the first set of alternate
electrically conductive annular electrode stripes and being designed for connection to a second supply
terminal of a source of alternating current electric excitation potential.
9. Electrically conductive tubing according to claim 8 wherein the tubing is inserted in a flow-thru blood
treatment system between a hypodermic needle employed to withdraw and/or supply blood from a donor
and/or to a recipient and/or a blood storage receptacle or to a patient in a blood recycling system.
10. Electrically conductive tubing according to claim 9 wherein a blood pump is inserted in the tubing
between a donor and a recipient and/or a receptacle, and the tubing is part of a system that further includes
means for electrically isolating the blood pump from the electrically conductive tubing, means for regulating
blood flow from the output of the blood pump, and means for electrically interconnecting the input and output
sides of the tubing around the blood pump and blood flow regulating means whereby electrical continuity is
maintained through a desired length of the tubing.
11. An electrically conductive vessel according to claim 2 wherein the walls of the vessel itself are formed
from electrically conductive polymer material that is compatible with human tissue and blood and/or other
body fluids with the electrically conductive portions being formed into desired patterns of spaced apart
electrically conductive electrode segments physically interconnected by integrally formed electrically
insulating tubing walls portions which electrically isolate a first array of electrode segments from a second
array of electrode segments.
12. An electrically conductive vessel according to claim 11 wherein the vessel is in the form of tubing and
the electrically conductive electrode segments are in the form of zebra stripes which extend longitudinally
parallel with the longitudinal axis of the tubing with the alternate electrically conductive electrode stripes
being separated by alternate electrically insulating stripes for electrically isolating the alternate electrically
conductive electrode stripes one from the other, a first set of alternate ones of the electrically conductive
electrode stripes being electrically connected in common to a first annular terminal buss formed on and
circumferentially surrounding the tubing and electrically isolated from the remaining second set of alternate
electrically conductive electrode stripes, said first annular terminal buss being designed for connection to
one supply terminal of a source of alternating current electric excitation potential, and a second annular
terminal buss circumferentially surrounding the tubing and electrically connected to the remaining second
set of alternate electrically conductive electrode stripes, said second annular terminal buss being electrically
isolated from the first annular terminal buss and the first set of alternate electrically conductive electrode
stripes and being designed for connection to a second supply terminal of a source of alternating current
electric excitation potential.
13. Electrically conductive tubing according to claim 12 wherein the tubing is inserted in a flow-thru blood
treatment system between a hypodermic needle employed to withdraw and/or supply blood from a donor
and/or to a recipient and/or a blood storage receptacle or to a patient in a blood recycling system.
14. Electrically conductive tubing according to claim 13 wherein a blood pump is inserted in the tubing
between a donor and a recipient and/or a receptacle, and the tubing is part of a system which further
includes means for electrically isolating the blood pump from the electrically conductive tubing, means for
regulating blood flow from the output of the blood pump, and means for electrically interconnecting the input
40
and output sides of the tubing around the blood pump and blood flow regulating means whereby electrical
continuity is maintained throughout a desired length of the tubing.
15. An electrically conductive vessel according to claim 11 wherein the vessel is in the form of tubing and
the electrically conductive electrode segments are in the form of zebra stripes which extend radially around
the inside diameter of the tubing in alternating conductive and insulating annular bands whereby alternate
conductive bands are electrically isolated one from the other by respective insulating bands, a first set of
alternate ones of the electrically conductive annular electrode stripes being electrically connected in
common to a first longitudinally extending terminal buss that is formed on the tubing in parallel with the
longitudinal axis thereof and electrically isolated from the remaining second set of alternate electrically
conductive annular electrode stripes, said first longitudinally extending terminal buss being designed for
connection to a first supply terminal of a source of alternating current electric excitation potential, and a
second longitudinally extending terminal buss electrically connected to the remaining second set of alternate
electrically conductive annular electrode stripes, said second longitudinally extending terminal buss being
electrically isolated from the first longitudinally extending terminal buss and the first set of alternate
electrically conductive annular electrode stripes and being designed for connection to a second supply
terminal of a source of alternating current electric excitation potential.
16. Electrically conductive tubing according to claim 15 wherein the tubing is inserted in a flow-thru blood
treatment system between a hypodermic needle employed to withdraw and/or supply blood from a donor
and/or to a recipient and/or a blood storage receptacle or a patient in a blood recycling system.
17. Electrically conductive tubing according to claim 16 wherein a blood pump is inserted in the tubing
between a donor and a recipient and/or a receptacle, and the tubing is part of a system that further includes
means for electrically isolating the blood pump from the electrically conductive tubing, means for regulating
blood flow from the output of the blood pump, and means for electrically interconnecting the input and output
sides of the tubing around the blood pump and the blood flow regulating means whereby electrical continuity
is maintained throughout a desired length of the tubing.
18. A fluid treatment process for attentuating bacteria, and/or virus, and/or parasites, and/or fungus, existing
in blood and/or other body fluids and/or synthetic fluids within a treatment vessel having only biologically
compatible internal and conductive electrode surfaces therein contacting fluid being treated thereby
maintaining the biological usefulness of the blood or other fluids being treated comprising subjecting the fluid
within the treatment vessel to low voltage, low alternating current electric field forces within non-biologically
damaging electric field forces for producing a biologically compatible current flow through the blood or other
fluids for a predetermined period of time sufficient to attenuate bacteria and/or virus, and/or parasites and/or
fungus contained in the blood or other fluids to thereby render them ineffective while maintaining the
biological usefulness of the fluids being treated.
19. The product of the process according to claim 18.
20. A fluid treatment process according to claim 18 wherein the low voltage alternating current electric
potentials are in the range from about 0.2 to 12 volts and induce electric current flow densities in the blood
or other fluids of from one microampere per square millimeter (1 muA/mm(^2)) to about two milliamperes per
square millimeter (2 mA/mm(^2)).
21. The product of the process according to claim 20.
22. A fluid treatment system for attentuating bacteria, and/or virus, and/or parasites, and/or fungus existing
in blood and/or other body fluids and/or synthetic fluids being treated without biological damage to the blood
or other fluids comprising an electrically conductive vessel formed at least in part of biologically compatible
conductive material for contacting blood or other fluids to be treated, means for subjecting the blood or other
fluids within the conductive vessel to low voltage, low alternating current electric field forces for producing
biologically compatible current flow through the blood or other fluids for a predetermined period of time
sufficient to attenuate bacteria and/or virus, and/or parasites, and/or fungus contained in the blood or other
fluids to thereby render such contaminants ineffective while maintaining the biological usefulness of the
blood or other fluids.
41
23. A fluid treatment system according to claim 22 wherein the low voltage alternating current electric
potentials are in the range from about 0.2 to 12 volts and produce electric current flow densities in the blood
or other body fluids of from one microampere per square millimeter (1 muA/mm(^2)) to about two
milliamperes per square millimeter (2 A/mm(^2)).
24. A fluid treatment system according to claim 22 wherein the system comprises a plurality of components
including an electric power source all of which the miniaturized and implanted in the body of a patient being
treated to form a closed loop, continuous recirculating body fluid treatment system.
25. A fluid treatment system according to claim 22 wherein the conductive vessel is in the form of an open
ended tube to allow flow-thru treatment of blood and other fluids and is miniaturized along with an electric
power source for supply of alternating current electric potentials thereto whereby the system may be
implanted in human beings and other mammals to operate as a continuous recirculating fluid treatment
process.
26. A fluid treatment system according to claim 22 wherein the conductive vessel in the vicinity of the
spaced-apart opposed electrically conductive electrode segments is provided with an enlarged cross
sectional area wherein enlarged electrically conductive electrode segment surface areas are provided to act
on the blood or other fluids flowing through the vessel thereby increasing the through-put and/or
effectiveness of the treatment accomplished within the vessel for a given dwell time.
27. A body fluid treatment system according to claim 26 wherein the electrically conductive vessel comprises
an enlarged rectangular-shaped body of electrical insulating material having a plurality of parallel,
longitudinally extending tubular openings formed all the way through the insulating material from one end to
the other and having spaced-apart electrically conductive metal strips secured to respective opposite sides
of all of the tubes in opposed, parallel relationship, one set of corresponding conductive strips of all of the
tubes extending out of the ends of each tube on one side or end of the body of electrical insulating material
and contacting a conductive surface forming a terminal buss for all conductive strips of the set, and the
remaining set of conductive strips projecting out of the opposite ends of the respective tubes on the opposite
end of the insulating block to engage a conductive terminal surface, and header reservoirs formed on each
of the ends of the body of electrical insulating material into which the ends of the tubular openings are
connected, each header having a respective inlet or outlet opening for supply of blood and/or other fluids for
treatment thereto.
28. A fluid treatment system according to claim 27 wherein the enlarged insulating clock member is
cylindrically shaped and the header reservoirs at each end of the block member are correspondingly
cylindrically shaped.
29. A fluid treatment system according to claim 27 wherein selectively operated gas vents are provided in
the top of the respective header reservoirs of the electrically conductive vessel.
30. A fluid treatment system according to claim 26 wherein the electrically conductive vessel is in the form of
an enlarged cross sectional area treatment vessel of substantially greater cross sectional area than the inlet
and outlet conduits supplying body fluids to be treated to the vessel and wherein the enlarged cross
sectional area vessel is included in a blood transfer system between a hypodermic needle employed to
withdraw and/or supply blood from a donor and/or to a recipient and/or a blood storage receptacle or to a
patient in a continuous flow-thru blood recycling system.
31. A fluid treatment system according to claim 30 wherein a blood pump is inserted in the flow path of the
blood or other fluid either to or from the enlarged cross sectional area vessel, or both, and are located in a
tubing system between the donor and recipient or receptacle, and the system further includes means for
regulating blood flow rate from or to the enlarged cross sectional area treatment vessel via the inlet or outlet
pumps or both.
42
Appendix 3:
Originally Published in
the American Naturopathic Medical Association Monitor
Bioelectrical Stimulation for People with Patterns
Consistent with Certain Chronic Infections
ANMA Monitor 2(4):5-9.1998).
Robert J. Thiel, Ph.D., N.H.D., Director of Research, Doctors’ Research
Key words: infections, bioelectrical stimulation, zappers, nutrition, parasite, fungi, virus,
staphylococci, streptococci, alternative health, antibiotic alternatives
ABSTRACT
The purpose of this pilot trial was to determine whether there may be any efficacy to
combining the use of bioelectrical stimulating units with nutritional interventions for
people with patterns consistent with chronic fungal, bacterial, viral, or parasitic
infections. This trial was a pretest-posttest, natural control-group design where subjects
were assessed before and after bioelectrical stimulation was introduced by the use of a
device, most commonly referred to as a ?zapper?. 140 of 143 (97.9%) participants
reported improvement within 45 days, P<.01; 48.2% improved substantially and 49.7%
improved minimally. Thus, it appears that combining bioelectrical stimulation with
nutritional interventions may have efficacy and deserves further study.
Thiel R. Bioelectrical Stimulation for People with Patterns Consistent with Certain Chronic Infections. ANMA Monitor, 1998; 2(4):5-9
Thiel R. Bioelectrical Stimulation for People with Patterns Consistent with Certain Chronic Infections. Townsend Letter, 2000; 203:65-67
INTRODUCTION
Reports of infections are on the increase [1-4]. Within the past two decades, at least
twenty new infectious diseases (or new presentations of old infectious diseases) have
become universally recognized as problems for humans [3,4]. Increases of infections are
believed to be caused by changes in lifestyle, diet, agricultural practices, travel, and
medical interventions [2-4]. Regarding medical interventions, the excessive use of
antibiotics has led to an increase of bacteria which are resistant to antibiotics [5]. This, in
turn, has led to the development of stronger antibiotics, which then has led to an increase
of the amounts of strains of bacteria which are resistant to antibiotics [5,6]. There is even
a strain of staphylococcus aureus that was initially described as ?a deadly bacterium that
can resist every drug in science’s infection-treatment arsenal? [7]. Approaches other than
antibiotics are needed to deal with these and other infections [2,5].
One approach, as advocated by Hulda Clark (Ph.D., N.D.), involves the use of
bioelectrical stimulation (which she terms ?zapping?) combined with herbal interventions
43
[2]. Dr. Clark believes that all invading organisms are parasitic and can be destroyed by
zapping or by being exposed to an electronic field at a frequency taken from its own
bioradiation band width, and that devices exist which can generate the proper
frequencies. Similar to my hypothesis that all matter appears to emit some type of
electro-magnetic energy [8], Dr. Clark has hypothesized that all living matter emits some
type of high frequency energy (which she terms as ?bioradiation?). Dr. Clark believes
that a particular frequency range for each form of living matter can be identified and that
a lethal effect can be obtained through a device she refers to as a ?zapper? [2]. Others
have made units which predate her comments, even back in the 19th Century [9,10].
Actually, instructions on how to make such devices are now nearly universally available
from a variety of copyrighted sources (and these devices are often made and used by the
lay public without any type of supervision) [2,9,11,12]. Dr. Clark has stated that a zapper
can selectively electrocute parasitic organisms without adversely affecting humans
because humans are not harmed by such a low voltage (9v) and that the frequencies that
affect parasites are sufficiently far removed from those that could bother humans [2]. A
clinical trial was performed to determine if such interventions may have any efficacy
when combined with nutritional interventions.
MATERIALS AND METHOD
Non-HIV infected adults were eligible for inclusion in this pretest-posttest trial if they
resided in California, came to our office, agreed to provide (and did provide) feedback,
signed a consent agreement, had evidence of a pattern of chronic infection consistent
within the scope of this trial, had not completely responded to previous nutritional
interventions, were not pregnant, did not wear a pacemaker, underwent at least one
zapping session, and followed the nutritional recommendations. The natural control
group met the same criteria, except that they did not undergo a zapping session.
This report includes every subject who met these criteria during the twelve month time
period of this trial. 158 people were eligible, but 15 failed to provide the required
feedback. Of the 143 actual participants, 41 of the participants were male and 102 were
female. Ages ranged from 5 to 84 years. 34 were in the natural control group, but 3 failed
to provide the required feedback. Of the 31 actually in the natural control group 9 of them
were male and 22 of them were female; ages ranged from 4-82. All were interviewed for
approximately 30 minutes. Signs and symptoms associated with their possible infections
were noted. Five categories of infection were considered without regard to specific
species, strains, or varieties. All continued with their nutritional recommendations (taking
commercially available vitamin, herbal, and glandular combinations), including dietary
restrictions when involved. As the nutritional interventions, have been written about
extensively elsewhere by this investigator [8,13-15] and are not the independent variable
being tested in this trial, they are not detailed in this paper. Subjects then underwent one
or more zapping sessions. Subjects were re-interviewed approximately three weeks later
to determine any change.
44
As the State of California does not allow naturopaths to order medical tests, changes in
health in this pilot trial was based upon subject reports of improvement. A zapping
session consisted of having the participant hold a zapping unit (two different ones were
used in this study) three times for between 7 to 15 minutes each time, with a break of
between 10-20 minutes (time varied depending upon the zapper used).
Two different zappers were used: A commercial model and a specially engineered model.
The commercial model used was a SyncroZap Pulse Generator Model B3 from Self
Health Resource Center, Imperial Beach, California; it is operated by a 9 volt battery and
produces a 32KHz output. The engineered model was based upon the same design as the
commercial model (was also operated by a 9 volt battery), but due to an extra integrated
circuit, its output sweeps the frequency in steps of 2 KHz from 20 - 40 KHz (this
sweeping is believed by the developer to generate an output at 10 times as many
frequencies than the commercial model). The commercial model was normally held for 7
minutes with 15-20 minute breaks, while the engineered model was normally held for 15
minutes with 10 minute breaks.
RESULTS
Reflex assessment, combined with the interview process, suggested that the average
participant had 1.1 chronic infections (note that reflex assessment is not diagnostic [8]).
48.2% reported substantial symptomatic improvement (between 75% improvement to
complete remission), whereas 49.7% reported minimal improvement (less than 75%
improvement); total with any improvement was 97.9%. In the control group, the average
control also had 1.1 chronic infections; 12.9% reported significant improvement, whereas
48.4% reported minimal improvement; total with any improvement was 61.3%.
Improvement (from both groups) was reported for symptoms including bloating, diarrhea,
constipation, flatulence, fecal incontinence, congestion, fatigue, lethargy, skin rashes,
itching, abdominal pain, indigestion, and coughing. Analyzing the results utilizing Chi-
square, comparing the two groups for total improvement and any improvement revealed
P <.0.1 and P <0.01 respectively.
The improvement by possible infection type for the participants is shown below.
Type.............. %...... Substantially Improved....... % Minimally Improved
Strep........... 2.8%............ 75.0%................................ 25.0%
Staph......... 10.5% ...........60.0%................................ 33.3%
Viral........... 21.7%........... 35.5%................................ 61.3%
Fungal........ 33.6%........... 39.6%................................ 60.4%
Parasitic..... 42.7%............ 59.0%............................... 37.7%
The commercial zapping model seemed to require more repeated sessions than the
engineered model to get similar results: this could be because the engineered model was
designed differently (with an extra circuit) and/or because it was held by the participants
longer. When long-term staphylococcus infections were present that did not clear-up with
conventional antibiotic treatments, the engineered model seemed to be substantially more
45
effective than the commercial model. 97.9% of participants reported symptomatic
improvement; with 97.4% zapped with the commercial model and 98.4% with the
engineered model (both combined with supplementation) reporting improvement. Neither
age nor gender were found to have any significant impact on improvement.
Temporary (lasting less then one hour) adverse reactions to zapping, specifically
dizziness or a near intoxicating feeling, were noted from three (2.1%) of the participants;
all of which stated that benefits associated with the zapper exceeded the temporal adverse
reactions. (A recent monograph by Dr. Robert Beck regarding the use of a similar device
states ?if subjects ever feel sleepy, sluggish, listless, bloated or headachy, or have flu-like
reactions, they may be neglecting sufficient water intake? [16]. Dr. Clark advises that
those who are pregnant or wearing a pacemaker should not use a zapping unit [2]) A
more commonly heard comment was that some participants (5.1%) felt refreshed or
relaxed after undergoing the zapping sessions. Temporary adverse reactions to
supplementation included increased itching (in subjects who had previously complained
of itching), increase of various reported symptoms, and mild intestinal discomfort: these
complaints were only temporary when they occurred (generally less than one week).
DISCUSSION
This trial did not include anyone who completely responded to previous nutrition-only
interventions. My previous research has clearly shown that nutritional interventions can,
on their own, result in symptomatic improvement when chronic infections are present
[14,15]. This trial attempted to see if adding the intervention of bioelectrical stimulation
could result in symptomatic improvement to greater degrees for people with chronic
infections. Many of the participants were greatly impressed by the effectiveness of the
zapper; some who improved, however, felt the zapper had no effect and improvement
was entirely due to the continued use of supplementation.
Although most understand that bacterial and viral infections are common [1-4], many
health practitioners do not seem to understand that yeast/fungal infections and parasites
are often found in humans [17,18]. Although one major study found parasites in 20.1% of
stool samples [18], many of these parasites appear to not always cause detectable
symptoms [1]. In humans, most parasites are believed to live within the digestive tract
[1,18] (though Dr. Clark has implied that this may not be the case [2]). Parasites, by
nature, must be able to live in an organism for a long-time without killing the host
organism or getting killed by it [19]. Thus, it is not surprising that the highest percentage
of the participants had this type of infection.
How does zapping work? Dr. Clark has written, ?Any positively offset frequency kills all
bacteria, viruses and parasites simultaneously given sufficient voltage (5 to 10 volts),
duration (seven minutes), and frequency (anything from 10 Hz to 500,000 Hz)? [2]. A
positive offset frequency is one which alternates between positive and zero voltage. I am
not at all certain that zapping actually kills any invading microorganism. This trial
suggests that since only 48.3% improved substantially, zapping probably did not kill ?all
46
bacteria, viruses and parasites? (according to Dr. Clark’s book, the reason could be that
possibly the current did not access all body regions, specifically the bowel contents [2]).
There are several reasons to believe that there may be scientific justification for the use of
zappers. First, it needs to be understood that precisely how the body combats parasitic
infections is not fully known [20]; this may be because many of the disease causing
parasites have the ability to turn off immune responses [20]. (Both immune and non-
immune responses are involved in the body’s defenses against pathogens of all types
[20].) It is possible that the body produces additional acid, has an IgG response [1,21], or
has other actions to deal with intestinal parasites [20]. Second, it needs to be understood
that both the colon and the small intestine produce electrical spike bursts [22]. Third,
animal studies support the hypothesis that electrical stimulation has various effects on the
body, including the inactivation of muscle acetyl CoA carboxylase and increasing AMP-
activated protein kinase [23]. The inactivation of muscle acetyl CoA carboxylase may
temporarily increase pyruvic acid [24] or decrease the effectiveness of normal portions of
the immune system [25]. It has been reported that researchers from the Albert Einstein
College of Medicine found that passing a current of only 50 microamps can prevent
certain viruses (including HIV) from replicating [26]. It is of interest to note that a
technique recently developed at the Royal London Hospital uses gracilis muscle
augmentation combined with electrical stimulation to improve sphincter control in
individuals with fecal incontinence [27] (some of the subjects in this trial had this
symptom).
It may be possible that some of the body’s defense mechanisms against pathogens
include electrical activity or that electrical activity may improve nutrient absorption. This
last hypothesis is consistent with work performed by Dr. J.C. Weaver. Dr. Weaver
performed a study in which he found that electrical stimulation appeared to make the
body’s cell walls more permeable so that its response to infection after ingesting
supplemental nutrients was enhanced [28]. It is also consistent with a similar hypothesis
written in 1924 by Dr. E.W. Cordingley that ?electrotherapy? increases ?local nutrition?
[29].
Why does a subject undergo three zappings? Dr. Clark and this investigator have
different opinions. Dr. Clark has written that the first zapping ?kills viruses, bacteria, and
parasites. But a few minutes later, bacteria and viruses (different ones) often recur. I
conclude they had been infecting the parasites, and killing the parasites released them.
The second zapping kills the released viruses and bacteria, but soon a few viruses appear
again. They must have been infecting some of the last bacteria. After a third zapping, I
never find any viruses, bacteria, or parasite, even hours later?[2]. This investigator does
not agree, however, because often the same infection remains. It appears that repeated
zappings are needed because it takes that long for the proper portion of the immune
system to be properly stimulated into action. And I should add, for some people it only
seems to be needed one or two times (some many more).
There are at least 130 different parasites [2,17], many different bacteria and viruses [4-7],
and at least 150 medically significant yeast/fungi (Candida albicans is only 1 of them)
47
[17,30]. Is the solution to the multiple infectious agents, as has been proposed by some
[6], new antibiotics? With deadly infections that do not respond to ?drug-based?
treatments [4-7], should not other avenues be explored? The results of this study suggest
that zapping combined with nutritional interventions may have helped most of the
participants improve. Nutritional interventions give the body substances which it can use
to improve immune responses [18]. Although this is not certain, it appears that either
nutrient absorption is somehow improved [28,29] or IgG (immunoglobin G) [1,19], some
T cell (T-lymphocyte), biochemical acid, or some other defense mechanism is somehow
stimulated through zapping and thus some segment of the immune system, but not the
zapper, destroys the invader. Regardless of which (or whose) hypothesis is correct, it can
be concluded that zapping and nutritional interventions can be helpful adjuncts for people
with various forms of chronic infection and does deserve additional study.
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[1] Targan S, Shanahan F 1990 Immunology and Immunopathology of the Liver and
Gastrointestinal Tract. Igaku-Shoin Medical Publishers, New York.
[2] Clark H 1995 The Cure for All Diseases. New Century Press, San Diego.
[3] Lorbor B. Changing patterns of infectious disease revisited. Am J Phar 1991; 1163:5-
17.
[4] Nugent S. New viruses in the jungle. ANMA Update 1995; 1 (2): 1
[5] Norby SR. Antibiotic resistance: A self-inflicted problem. J Int Med 1996; 239:373-
375.
[6] Bradley J, Scheld W. The challenge of penicillin-resistant Streptococcus pneumoniae
meningitis: current antibiotic therapy in the 1990s. Clin Inf Dis 1997; 24 (Sup.2):S213-
S221.
[7] Supergerm resists antibiotics. The Good News 1997; 2 (5):13.
[8] Thiel RJ 1995 Serious Nutrition for Health Care Professionals. California Health
Group, Arroyo Grande (CA).
[9] Dr. Detox Circa 1987 The Scalartronix: Rife Generator Operations Manual and
Training Program. San Diego.
[10] Card #36 Shock Machine at Ripleys Odditorium, Hollywood, California
(Specifically Identified as Electric Magneto Machine).
[11] Beck R March 16, 1996 Experimental in vivo blood clearing device for eliminating
viruses pathogens, microbes, bacteria, fungi, and parasites. Robert Beck, Santa Ana.
[12] Miller T. Building the bioelectrifier: Can you heal yourself and take a poke at the
medical establishment at the same time? Amateur Radio Today, May 1997:13-19.
[13] Thiel R. Natural interventions for systemic mycoses. JANA, in review 1998.
[14] Thiel RJ. Nutrition to improve the CD4 count of persons with AIDS. National
Institutes of Health, Bethesda. April 1997:Submittal NTN B1.
[15] Thiel RJ. Chronic fatigue assessment and intervention. ANMA & AANC J 1996; 1
(3):17-19.
[16] Beck R March 20, 1997 Expanded instructions for experimental/theoretical blood
electrification. Robert Beck, Santa Ana.
[17] Chandler FW, Watts JC 1990 Mycotic, actinomycotic, and algal infections. In
Anderson’s Pathology, 9th ed., Mosby, St. Louis, pp. 391-432.
48
[18] Results of testing for intestinal parasites by state diagnostic laboratories, United
States, 1987. Morbidity and Mortality Weekly 1992; 40 (SS4):25-30.
[19] Frank SA. Models of parasite virulence. Qtr Rev Bio 1996; 71 (1):37-78.
[20] Keusch G 1994 Nutrition and Infection. In Modern Nutrition in Health and Disease,
8th ed.. Lea & Febiger, Philadelphia, pp. 1241-1258.
[21] Akue JP, et al. High levels of parasite-specific IgG1 correlate with the
amicrofilaremic state in Loa loa infection. J Inf Dis 1997; 175 (1):158-163.
[22] Medeiros JA, Pontes FA, Mesquita OA. Is colonic electrical activity a similar
phenomena to small-bowel electrical activity? Dis. Colon Rectum 1997; 40 (1):93-99.
[23] Hutber CA, Hardie DG, Winder WW. Electrical stimulation inactivates muscle
acetyl-CoA carboxylase and increases AMP-activated protein kinase. Am J Phys 1997;
(2pt1):E262-E266.
[24] Sidransky H 1990 Malnutrition and Deficiency Diseases. In Anderson’s Pathology,
9th ed. Mosby, St. Louis, pp. 546-565.
[25] Dakshinamurti K 1994 Biotin. In Modern Nutrition in Health and Disease, 8th ed.
Lea & Febiger, Philadelphia, pp. 426-448.
[26] Shocking treatment proposed for AIDS. Science News, March 30, 1991:207.
[27] Stuchfield B. The electrically stimulated neoanal sphincter and colonic conduit. Brit
J Nurs 1997; 6 (4):219-224.
[28] Weaver JC. Electroporation: A general phenomenon for manipulation of cells and
tissue. J Cell Bio 1993; 51:426-435.
[29] Cordingley EW 1924 (Reprint 1971) Principles and Practices of Naturopathy. Health
Research, Mokelume Hill (CA), pp. 12-14.
[30] Larone DH 1993 Medically Important Fungi, 2nd ed. American Society of
Microbiology, Washington.
Appendix 4. Electrical Stimulation And Wound Healing References
Agren M.S., Engel M.A., and Mertz P.M. (1994) Collagenase during burn wound healing:
influence of a hydrogel dressing and pulsed electrical stimulation. Plast. Reconstr.
Surg. 94, 518-524. Abstract: Epithelialization of second-degree burn wounds is
known to be accelerated by topical treatment with hydrogel dressings and further
enhanced by pulsed electrical stimulation compared with no treatment (air exposure).
Tissue collagenase has been proposed to be involved during the process of
epithelialization. In the present study collagenase levels were examined in partial-
thickness burn wounds in the skin of four domestic pigs. Collagenase levels,
assayed on postburn days 1 to 10, were substantially reduced in deblistered and air-
exposed burn wounds compared with excisional partial-thickness wounds. Early
application of hydrogel dressing to the burn wounds was accompanied by elevated
collagenase activities and an increased inflammatory reaction in dermis. Addition of
pulsed electrical stimulation increased (p < 0.001) collagenase levels twofold above
those with hydrogel alone during initiation of epithelialization (postburn days 3 and
4). These results suggest that collagenase is closely linked to wound epithelialization
Ahl T., Andersson G., Herberts P., and Kalen R. (1984) Electrical treatment of non-
united fractures. Acta Orthop. Scand. 55, 585-588. Abstract: The semi-invasive
technique for electrical stimulation of bone healing developed by Brighton et al.
(1977) was used in 23 patients with nonunited fractures of the tibia (14 cases),
49
humerus (4 cases), scaphoid, femur and fibula as well as one failed arthrodesis of
the ankle. The fractures were clinically not healed and not operated on within a
minimum of 6 months. The mean period from fracture to treatment was 18 months.
Electrical stimulation led to solid bone healing in 10 cases. Two deep infections
occurred during the treatment. Of 13 cases that did not unite, a great range of motion
in the nonunion area was an obvious cause of failure in seven cases. The results in
this series cannot compete with those of bone graft surgery for nonunions
Ahmed A.N., Islam K.M., Rahman M.F., Islam M.S., and Rabbani K.S. (1987) Effect of
electrical stimulation on the early phase of healing in induced fracture in rat tibiae.
Bangladesh Med. Res. Counc. Bull. 13, 69-79.
Akai M., Oda H., Shirasaki Y., and Tateishi T. (1988) Electrical stimulation of ligament
healing. An experimental study of the patellar ligament of rabbits. Clin. Orthop. 296-
301. Abstract: To examine the effects of direct electric current on ligament healing in
rabbits, a full-thickness defect of the patellar ligament was electrically stimulated for
time periods of up to seven weeks. The rabbits were randomly assigned to
biomechanical and biochemical studies, and healing was evaluated by these
parameters. Electrical stimulation was shown to restore tensile stiffness in a short
period of time and to decrease the relative proportion of Type III collagen more
rapidly than in the control group. However, electrical stimulation did not change the
collagen content of newly formed tissue. Electricity enhances the repair process of
the ligament by changing the ratio of collagen types
Akai M., Wadano Y., Yabuki T., Oda H., Sirasaki Y., and Tateishi T. (1991) [Effect of a
direct electric current on modification of bone and ligament repair processes--
experimental investigation of a rabbit model]. Nippon Seikeigeka Gakkai Zasshi
65, 196-206. Abstract: Investigations of the effect of direct current on 1)
fracture healing, and 2) ligament healing was conducted by applying 10
microA to 1) the defect of the fibula, and 2) that of the patellar ligament of
adult rabbits. After time periods for stimulation all specimens were tested with
combinations of roentgenological, histological, biomechanical and
biochemical methods. The results were analyzed and compared with the non-
stimulated, opposite side and with the normal tissue. The electricity produced
1) a more massive callus with normal histological features in an early stages
at the fracture site, and 2) higher tensile stiffness and earlier change of the
collagen types in the newly-formed tissue, though no significant differences
were observed as to 1) the mechanical parameters of callus and bone
material, and 2) histological findings of repairing tissue. Electrical stimulation
was indicated not only on bone tissue but also on non-osseous tissues and
their components
al Holou N., Benghuzzi H., and Forbes K. (1997) Development of a
microcomputer-based system to monitor healing from injury. Biomed. Sci.
Instrum. 34, 181-185. Abstract: It is well documented that induction of electric
current in bone not only prevents the bone loss of functional disuse, but also
induces new bone formation. Moreover, the literature suggests that the
50
skeletal response is optimal at a distinct frequency range 10-30 Hz. Indeed,
even at peak strains, well below those typical of habitual physiological
loading, applications of 30 Hz were shown to be osteogenic. This evidence
supports the concept that inducing even very low strains may generate an
effective osteogenic stimulus, provided that they are induced at optimal
frequency (10 to 30 Hz). Bone appears to respond with greater selectivity and
sensitivity to this frequency range of electrical stimulation. Inducing insulin-like
growth factors, which are negatively charged, will provide the required
electrical stimulus. Traditionally, the progression of the cellular events during
trauma is normally followed by x-ray to determine a healing rate. Frequent
use of this method can result in serious side effects to the vital and
reproductive organs. The objective of this study is to develop a
microcomputer-based system to monitor the cellular events associated with
healing. The system is capable of transmitting an electrical signal directly to
the site of injury to improve the healing process and to monitor the progress
of osteogenesis. The system consists of a base unit and implanted units. One
implanted unit will be inserted in the femur with induced trauma and the other
implant will be in the control femur. The base unit will transmit low frequency
electromagnetic waves to the implanted units as well as receive periodic
information about the ion movement in both femurs
Albert S.F. and Wong E. (1991) Electrical stimulation of bone repair. Clin.
Podiatr. Med. Surg. 8, 923-935. Abstract: Interest in methods of accelerating
bone healing persists. Electrical stimulation has demonstrated consistently
high success rates in recalcitrant, complicated nonunions. The promise of
successful noninvasive alternatives for treating nonunions continues to be
realized. Given the rapidity of advances in this field, it appears likely that
acceleration of fracture repair by electrical stimulation will become more
widespread in the future
Alexander L.G. (1997) HCFA's decision to not cover electrical stimulation for the
treatment of wounds is delayed 60 days. Ostomy. Wound. Manage. 43, 62.
Ammer K. (1994) [Electrotherapy]. Wien. Med. Wochenschr. 144, 60-65.
Abstract: Electrotherapy is defined as the sum of therapeutic modalities of
physical medicine capable to change the threshold of elicitation of nerve or
muscle. Classification due to applied pulse frequencies, way of action of
transcutaneous nerve stimulation (= TENS) and of iontophoresis is described.
Pain syndromes, muscle atrophy by loss of activity and support of wound
healing are named as accepted indications for electrotherapy. The difficulties
of electrical stimulation of paretic muscles and the problem, whether different
indications for certain forms of electrotherapy exist or not, is discussed
Aro H., Aho A.J., Vaahtoranta K., and Ekfors T. (1980) Asymmetric biphasic
voltage stimulation of the osteotomized rabbit bone. Acta Orthop. Scand. 51,
711-718. Abstract: An experimental study was performed to determine the
51
effect of electric current on the healing of osteotomies in the antebrachium of
the rabbit. Starting with the assumption that the waveform of biphasic
asymmetric voltage simulates the asymmetric pattern of stress-induced
physiological electrical potentials in normal bone, biphasic asymmetric
voltage was applied to the osteotomized radius or ulna. The effects of the
electrical stimulation were evaluated by means of X-rays and histological
studies. The voltage supplied induced periosteal proliferation whether
implanted, insulated electrodes were employed or uninsulated external
transfixation pins were used as electrodes. The stimulation had not only
osteogenic but also chondrogenic effect. The external callus formation at the
osteotomy sites and around the transfixation pins proved to be greater in the
stimulated animals than in the controls
Baker L.L., Chambers R., DeMuth S.K., and Villar F. (1997) Effects of electrical
stimulation on wound healing in patients with diabetic ulcers. Diabetes Care
20, 405-412. Abstract: OBJECTIVE: To evaluate the effects of two stimulation
waveforms on healing rates in patients with diabetes and open ulcers. The
hypothesis was that stimulus waveforms with minimal polar characteristics
would provide significant healing for this patient sample. RESEARCH
DESIGN AND METHODS: This was a prospective study that enrolled 80
patients with open ulcers. Patients received stimulation with either an
asymmetric biphasic (A) or symmetric biphasic (B) square-wave pulse.
Amplitudes were set to activate intact peripheral nerves in the skin. Two other
groups received either very low levels of stimulation current (MC), or no
electrical stimulation (C). When combined these groups were referred to as
the control group. Treatment was carried out daily until the wound healed, the
patient withdrew from the study, or the physician changed the overall wound
management program. Average healing rates were calculated from weekly
measures of the wound perimeter and were used for statistical comparison
through a one-way analysis of variance. RESULTS: Stimulation with the A
protocol significantly increased the healing rate, enhancing healing by nearly
60% over the control rate of healing. Stimulation with the B protocol did not
increase the healing rate when compared with control subjects.
CONCLUSIONS: Electrical stimulation, given daily with a short pulsed,
asymmetric biphasic waveform, was effective for enhancement of healing
rates for patients with diabetes and open ulcers
Bassett C.A., Becker R.O., Brighton C.T., Lavine L., and Rowley B.A. (1974)
Panel discussion: To what extent can electrical stimulation be used in the
treatment of human disorders? Ann. N. Y. Acad. Sci. 238, 586-593.
Bauerle J. and Neander K.D. (1996) [Use of pulsed electrical stimulation in the
therapy of decubitus ulcers]. Krankenpfl. J. 34, 270-275.
Becker M.H., Lassner F., Dagtekin F.Z., Walter G.F., and Berger A. (1995)
Morphometric changes in free neurovascular latissimus dorsi flaps: an
52
experimental study. Microsurgery 16, 786-792. Abstract: This study was
designed to investigate regeneration of reinnervated, free transplanted
muscles. We used a rat model, consisting of eight rats per group, in which the
latissimus dorsi muscle was transplanted orthotopically and then harvested
and evaluated after 2 and 12 weeks. Age-matched control animals were used
to oppose non-operated muscles. At date of removal the patency of the
vascular anastomoses was checked clinically and histologically.
Electrophysiological measurements were also performed and conventional
and enzyme histochemical histological slides manufactured. Two weeks after
the free neurovascular flap transfer the muscle was not yet innervated, and
histologically a dissolved pattern of type 1 and type IIA muscle fibres was
found. The muscle fibres demonstrated a decrease of more than 50% cross-
sectional area. After 12 weeks the muscles were reinnervated again; muscle
contraction was positive with electrical stimulation and the cross- sectional
area had regained 80% of the activity of normal muscle fibres. With enzyme
histochemical staining the typical type grouping of reinnervated muscles could
be demonstrated
Beer L., Hintner J., Kleditzsch J., and Lorenz T. (1990) [Behavior of alkaline
serum phosphatase (AP) and its bone isoenzyme in healing of the
osteotomized tibia in rabbits--an animal experimental study]. Z. Exp. Chir
Transplant. Kunstliche. Organe. 23, 230-232. Abstract: The effectiveness of
the electrical stimulation on the healing of an osteotomy was proved by
determining the total alkaline phosphatase (AP) in the serum and its bone
isoenzyme in rabbits. A non-stimulated animal group served as control. The
changes appeared more distinctly by interference stimulation than by
stimulation with bipolar rectangle impulses
Bertsch V. (1980) [The treatment of Dupuytren's contracture from the medical
gymnastic standpoint]. Handchirurgie. 12, 119-123. Abstract: A special
treatment program has been developed for each individual patient. Each day
the patient receives three different treatment modalities--active exercises,
passive exercises and electrical stimulation. On days when X-ray therapy is
administered, the patient performs only active exercises and receives no
electrical stimulation. The patient is also directed to perform certain exercises
at home. Patients are advised strongly against the use of hot baths. Dynamic
splints are adjusted regularly. In winter and during cold weather, patients are
instructed to wear gloves. This therapy, combined with meticulous surgical
technique, permits the rehabilitation of most hands affected by Dupuytren's
contracture. The goal of rehabilitation is tailored to the needs of the patient
and should include a sufficiently strong grasp, chuck pinch and possibly a
good pulp pinch. When necessary, the therapy should be continued for long
periods of time because a small gain in mobility may represent a significant
improvement in overall function of the hand
53
Biedebach M.C. (1989) Accelerated healing of skin ulcers by electrical
stimulation and the intracellular physiological mechanisms involved.
Acupunct. Electrother. Res. 14, 43-60.
Abstract: Evidence is reviewed (8 studies involving 215 clinical patients with
ischemic skin ulcers and 7 animal tissue or tissue culture studies) that
electrical stimulation of fibroblast cells accelerates the intracellular
biosynthesis necessary to form new granulation tissue in a healing wound,
and that both a direct local tissue effect and a circulatory improvement occur.
A model is presented in which transmembrane currents open voltage-
controlled calcium channels in fibroblast cells, causing ATP resynthesis,
activation of protein kinase mechanisms to synthesize new cellular protein,
and the DNA replication necessary for mitotic cell division. Stimulation
efficacy appears to be determined by a number of basic electrical parameters,
and judicious waveform control is desirable
Black J. (1985) Electrical stimulation of hard and soft tissues in animal models.
Clin. Plast. Surg. 12, 243-257. Abstract: Studies in animals have clearly
established that various forms of electrical stimulation positively affect the
growth, repair, and remodeling of hard and soft tissue. Although the various
electrical stimulation modalities (faradic, capacitive, and inductive) are
different in their physics and biochemistry, each produces a variety of
biological responses in a wide range of animal models. The level of interest in
animal studies of electrical stimulation is rising rapidly, and new
understanding, in parallel with studies in vitro and in the clinic, will continue to
be gained. The future holds the promise of a wide range of hard and soft
tissue conditions being routinely treated by electrical stimulation, based in
part on progress in studies in animals
Bogie K.M., Reger S.I., Levine S.P., and Sahgal V. (2000) Electrical stimulation
for pressure sore prevention and wound healing. Assist. Technol. 12, 50-66.
Abstract: This paper reviews applications of therapeutic electrical stimulation
(ES) specific to wound healing and pressure sore prevention. The application
of ES for wound healing has been found to increase the rate of healing by
more than 50%. Furthermore, the total number of wounds healed is also
increased. However, optimal delivery techniques for ES therapy have not
been established to date. A study of stimulation current effects on wound
healing in a pig model has shown that direct current (DC) stimulation is most
effective in wound area reduction and alternating current (AC) stimulation for
wound volume reduction at current densities of 127 microA/cm2 and 1,125
microA/cm2, respectively. Preliminary studies have been carried out at two
research centers to assess the role of ES in pressure sore prevention.
Surface stimulation studies have shown that ES can produce positive short-
term changes in tissue health variables such as regional blood flow and
pressure distribution. The use of an implanted stimulation system consisting
of intramuscular electrodes with percutaneous leads has been found to
54
produce additional long-term changes. Specifically, gluteal muscle thickness
increased by 50% with regular long-term ES application concurrent with a
20% decrease in regional interface pressures and increased tissue oxygen
levels. These findings indicate that an implantable ES system may have great
potential for pressure sore prevention, particularly for individuals who lack
sensation or who are physically unable to perform regular independent
pressure relief
Bogie K.M., Reger S.I., Levine S.P., and Sahgal V. (2000) Electrical stimulation
for pressure sore prevention and wound healing. Assist. Technol. 12, 50-66.
Abstract: This paper reviews applications of therapeutic electrical stimulation
(ES) specific to wound healing and pressure sore prevention. The application
of ES for wound healing has been found to increase the rate of healing by
more than 50%.
Furthermore, the total number of wounds healed is also increased. However,
optimal delivery techniques for ES therapy have not been established to date.
A study of stimulation current effects on wound healing in a pig model has
shown that direct current (DC) stimulation is most effective in wound area
reduction and alternating current (AC) stimulation for wound volume reduction
at current densities of 127 microA/cm2 and 1,125 microA/cm2, respectively.
Preliminary studies have been carried out at two research centers to assess
the role of ES in pressure sore prevention. Surface stimulation studies have
shown that ES can produce positive short-term changes in tissue health
variables such as regional blood flow and pressure distribution. The use of an
implanted stimulation system consisting of intramuscular electrodes with
percutaneous leads has been found to produce additional long-term changes.
Specifically, gluteal muscle thickness increased by 50% with regular long-
term ES application concurrent with a 20% decrease in regional interface
pressures and increased tissue oxygen levels. These findings indicate that an
implantable ES system may have great potential for pressure sore prevention,
particularly for individuals who lack sensation or who are physically unable to
perform regular independent pressure relief
Braddock M., Campbell C.J., and Zuder D. (1999) Current therapies for wound
healing: electrical stimulation, biological therapeutics, and the potential for
gene therapy. Int. J. Dermatol. 38, 808-817.
Branham G.B., Triplett R.G., Yeandle S., and Vieras F. (1985) The effect of
electrical current on the healing of mandibular freeze- dried bone allografts in
dogs. J. Oral Maxillofac. Surg. 43, 403-407. Abstract: Low levels of electrical
current have been shown to affect the process of osseous repair. This study
experimentally evaluated the effect of electrical stimulation on the healing of
freeze-dried mandibular allogeneic bone grafts in dogs. Healing of the grafts
was monitored by sequential submento-occlusal radiographs and radionuclide
bone imaging at two, four, six, and eight weeks after grafting. Results
55
indicated no significant difference in the osseous repair of stimulated and
nonstimulated freeze-dried allogeneic bone grafts
Brighton C.T., Hozack W.J., Brager M.D., Windsor R.E., Pollack S.R., Vreslovic
E.J., and Kotwick J.E. (1985) Fracture healing in the rabbit fibula when
subjected to various capacitively coupled electrical fields. J. Orthop. Res. 3,
331-340. Abstract: The effect of capacitively coupled electrical stimulation on
the healing of midshaft transverse osteotomies of the rabbit fibula is assessed
roentgenographically, mechanically, and histologically. The results show that
a dose-response curve for capacitive coupling and fracture healing exists and
that a 220 mV, 250 microA, 60 kHz applied electrical signal (0.33 V/cm
internal electric field) is the most effective signal for fracture stimulation in this
model
Brondbo K., Jacobsen E., Gjellan M., and Refsum H. (1992) Recurrent
nerve/ansa cervicalis nerve anastomosis: a treatment alternative in unilateral
recurrent nerve paralysis. Acta Otolaryngol. 112, 353-357. Abstract:
Sectioning of the right recurrent nerve was done in 5 mongrel dogs under
general anaesthesia. The distal stump was anastomosed with the ansa
cervicalis nerve branch to the sternothyroid muscle. Three to 5 months later
the vocal cord movements during light and very light anaesthesia were
videorecorded. Under light anaesthesia contraction and medial bulging of the
reinnervated right vocal cord
occurred in 4 of the dogs. Under very light anaesthesia there was also some
adduction of the right vocal cord in these 4 dogs. The right recurrent nerve
was then sectioned proximally to the anastomosis and stimulated electrically.
In all 5 dogs we observed that electrical stimulation produced a strong
adduction of the right vocal cord. Histochemistry of the right vocal and
posterior cricoarytenoid muscles showed that reinnervation had taken place.
The study indicates that in cases of unilateral vocal cord paralysis an
anastomosis between the ansa cervalalis and the recurrent nerve will result in
improved phonatory function of the affected vocal cord
Brown M., McDonnell M.K., and Menton D.N. (1988) Electrical stimulation effects
on cutaneous wound healing in rabbits. A follow-up study. Phys. Ther. 68,
955-960. Abstract: The purpose of this study was to determine the effects of
high voltage monophasic pulsed electrical stimulation on wound healing using
positive polarity. Forty-four rabbits were assigned to experimental or control
groups and followed for four or seven days. We classified the groups as
Exp4, Con4, Exp7, and Con7, respectively. Each animal was anesthetized,
and a full-thickness incision, 3.5-cm long, was made on its back. After 24
hours, the Exp4 and Exp7 rabbits received high voltage electrical stimulation
for two hours twice daily. Wound closure for the Exp4 rabbits (50%) was
significantly less than that of the Con4 rabbits (78%). After seven days,
however, the Exp7 and Con7 rabbits had similar wound-closure values (80%
56
and 82%, respectively). Tensile- strength values for the control and
experimental animals were comparable at both time periods. Histologic
examination of the wounds suggested a more rapid rate of epithelization
between the Exp4 and Exp7 rabbits compared with the Con4 and Con7
rabbits. The results of this study are inconclusive, but may indicate that
positive-polarity stimulation enhanced wound closure between four and seven
days of treatment
Buntine J.A. and Johnstone B.R. (1988) The contributions of plastic surgery to
care of the spinal cord injured patient. Paraplegia 26, 87-93. Abstract: Plastic
surgeons have contributed to the understanding of pressure sore
pathophysiology and prophylaxis. Increasingly sophisticated surgical
techniques such as myocutaneous or innervated flaps add to the reliability
and durability of repairs. The majority of quadriplegics may benefit from
surgical restoration of active elbow extension, lateral pinch and grasp.
Prolonged postoperative care in bed or immobilisation of the upper limb
demands that patients should understand fully all that the reconstructive
procedure involves. The nature and importance of subsequent rehabilitation
must be appreciated by the patient so that he will be motivated to achieve the
best possible result. Functional electrical stimulation may find an increasing
role in the years to come
Caliskan M.K. (1993) Success of pulpotomy in the management of hyperplastic
pulpitis. Int. Endod. J. 26, 142-148. Abstract: Hyperplastic pulpitis is a variety
of chronic open pulpitis which is regarded as irreversible. This condition is
usually treated by root canal treatment, unless coronal damage does not
permit restoration, in which case extraction is indicated. In the present study,
24 permanent teeth of individuals, aged 10-22 years and diagnosed as
hyperplastic pulpitis were treated by pulpotomy using an atraumatic surgical
technique with calcium hydroxide alone. The treatment was successful in 22
teeth, according to the following criteria: absence of clinical symptoms,
absence of any intraradicular or periradicular radiographic pathological
changes, presence of dentine bridge detected by clinical examination and
sometimes observed
radiographically, and sensitivity to electrical stimulation. The follow-up
examination ranged from 12 to 48 months. The high frequency of clinical
healing in this study appears to justify recommending pulpotomy as the
treatment regime in selected cases of chronic hyperplastic pulpitis
Carr R.W., Delaney C.A., Westerman R.A., and Roberts R.G. (1993) Denervation
impairs cutaneous microvascular function and blister healing in the rat
hindlimb. Neuroreport 4, 467-470. Abstract: Skin sensory nerve nocifensor
functions were investigated non- invasively in rats by measuring neurogenic
inflammation and blister healing-rate after unilateral hindlimb denervation.
Axon reflexes were evoked by transdermal iontophoresis of acetylcholine
57
(ACh) or noxious electrical stimulation (TNS). Sodium nitroprusside (SNP)
evoked direct dilator responses. Resultant changes in skin microvascular
blood flux were measured by laser Doppler flowmetry. Compared with their
sham- operated control limbs, denervation reduced inflammatory responses
(ACh or TNS) by more than 85% and SNP responses by 28% (p < 0.05).
Healing of dry-ice blisters raised on the hindpaw 14d post-denervation was
significantly slower to complete healing (42d) than controls (26d) and initial
inflammation was attenuated, confirming that innervation is important for
inflammation and blister-healing
Castillo E., Sumano H., Fortoul T.I., and Zepeda A. (1995) The influence of
pulsed electrical stimulation on the wound healing of burned rat skin. Arch.
Med. Res. 26, 185-189. Abstract: Electrostimulation of wounds caused
healing to proceed in a thoroughly organized manner. A trial using rats
subjected to second degree burns was conducted to evaluate, under
scanning electron microscopy (SEM), the healing capabilities of skin to which
an antiseptic (iodine) and referred electrical stimulation were applied.
Untreated, unharmed skin was also studied as control. Images obtained using
SEM revealed that only the repaired skin of the electrostimulated group had
an appearance similar to that of the control skin (kappa = 1), and that the
overall appearance of the repaired skin was compatible with a well organized
healing process
Chakkalakal D.A., Lippiello L., Shindell R.L., and Connolly J.F. (1990)
Electrophysiology of direct current stimulation of fracture healing in canine
radius. IEEE Trans. Biomed. Eng 37, 1048-1058. Abstract:
Electrophysiological mechanisms involved in the electrical stimulation of
fracture healing remain largely unknown. The purpose of the present study
was to establish relationships between osteogenetic response and
intraosseous measures of electrical dose in experimental fractures
(osteotomies) of canine radii stimulated by direct currents. The response was
determined postmortem at seven weeks after osteotomy by measuring the
bending rigidity and four physicochemical properties: tissue density, mineral
density, matrix density, and mineral-to-matrix ratio. The currents measured in
bone ranged from 0.1 to 17 microA. Three regions of enhanced osteogenetic
response were observed at approximately 1, 7, and 13 microA, separated by
regions of unstimulated response. Evidence presented in this paper suggests
that enhanced response resulted mainly from electrical modulation of early
events in the fracture repair sequence
Chakkalakal D.A., Lippiello L., Wilson R.F., Shindell R., and Connolly J.F. (1990)
Mineral and matrix contributions to rigidity in fracture healing. J. Biomech. 23,
425-434.
Abstract: The purpose of this study was to investigate the relationships among
selected properties of fracture callus: bending rigidity, tissue density, mineral
58
density, matrix density and mineral-to-matrix ratio. The experimental model
was an osteotomized canine radius in which the development of the fracture
callus was modified by electrical stimulation with various levels of direct
current. This resulted in a range of values for the selected properties of the
callus, determined post mortem at 7 weeks after osteotomy. We found that
the rigidity (R) of the bone-callus combination obeyed relationships of the
form R = axb, where x is the tissue density, mineral density, matrix density or
the mineral-to-matrix ratio of the repair tissue. These are analogous to power-
law relationships found in studies of compact and cancellous bone. The
results suggest that fracture callus at 7 weeks after osteotomy in canine
radius behaves more like immature compact bone than cancellous bone in its
mechanical and physicochemical properties. The present study demonstrates
the feasibility of developing non-invasive in vivo densitometric methods to
monitor fracture healing, since models may be developed that can predict
mechanical properties from densitometric data. Further studies are needed to
develop a refined model based on experimental data on the mechanical and
physicochemical properties and microstructure of fracture callus at different
stages of healing
Chang W.H., Hwang I.M., and Liu H.C. (1991) Enhancement of fracture healing
by specific pulsed capacitively-coupled electric field stimulation. Front Med.
Biol. Eng 3, 57-64. Abstract: The histologic procedure technique was used to
evaluate the bone fracture healing rate of manually fractured fibulae after they
were submitted to several different types of capacitively-coupled electric field
stimulation, classified depending on the parameters of peak-to- peak voltage,
frequency and duration. Using a completely randomized design, 30 New
Zealand male rabbits were divided into six different groups: a control group, a
60 kHz and 220 mVp-p sine wave group as proposed by Brighton in 1985,
and four special parameters of pulse wave groups. After comparing these
different types of electrical stimulation, the group with the parameters of a
pulse train repetition frequency of 15 Hz, a pulse frequency of 10 kHz and 5 V
peak-to-peak intensity experienced the same enhancement of bone fracture
healing as the group with the parameters suggested by Brighton in 1985
Cheng K., Tarjan P.P., and Mertz P.M. (1993) Theoretical study of rectangular
pulse electrical stimulation (RPES) onskin cells (in vivo) under conforming
electrodes. Biomed. Sci. Instrum. 29, 349-354. Abstract: Our previous in vivo
experimental results have shown RPES can enhance skin wound healing by
using conforming electrodes. Based on an equation of polarization
transmembrane voltage [Cole, K. S. 1972], two equations were derived to
describe the peak RPES intensity on skin cells in vivo: (1) U = 1.5 a J/sigma,
(2) Jm = 1.5 a (J/sigma) (Cm/tau). Where U: polarization transmembrane
voltage. a: radius (R) for spherical cells or semi-length (L) for long fibers
parallel to the electrical field. J: external imposed pulse current density under
the electrode. sigma: average conductivity of skin tissue. Jm: transmembrane
displacement current density. Cm: membrane capacitance per unit area and
tau: time constant. Calculations indicated that the sensory fibers (SF) would
59
receive the strongest stimulation compared to other cells in skin since
generally LSF > or = 100 R. The sensitivity of SF to the stimulation could
enhance skin wound healing as well as protect normal skin cells from harmful
electroporation. From these theoretical calculations. We proposed a
theoretical range of the pulse current density as: U1 sigma/(1.5 L) < or = J z
or = U2
sigma/(1.5 L), where U1 and U2 are the excitation threshold voltage (about 0.01
V) and polarization electroporation voltage (about 0.1 V) for a SF respectively,
for RPES to enhance skin wound healing
Cho M.R., Thatte H.S., Lee R.C., and Golan D.E. (2000) Integrin-dependent
human macrophage migration induced by oscillatory electrical stimulation.
Ann. Biomed. Eng 28, 234-243. Abstract: Electrical stimulation has been used
to promote wound healing. The mechanisms by which such stimulation could
interact with biological systems to accelerate healing have not been
elucidated. One potential mechanism could involve stimulation of
macrophage migration to the site of a wound. Here we report that oscillatory
electric fields induce human macrophage migration. Macrophages exposed to
a 1 Hz, 2 V/cm field show an induced migration velocity of 5.2+/-0.4 x 10(-2)
microm/min and a random motility coefficient of 4.8+/-1.4 x 10(-2)
microm2/min on a glass substrate. Electric field exposure induces
reorganization of microfilaments from ring-like structures at the cell periphery
to podosomes that are confined to the contact sites between cell and
substrate, suggesting that the cells are crawling on glass. Treatment of cells
with monoclonal antibodies directed against beta2-integrins prior to field
exposure prevents cell migration, indicating that integrin-dependent signaling
pathways are involved. Electric fields cause macrophage migration on laminin
or fibronectin coated substrates without inducing podosome formation or
changes in cellular morphology. The migration velocity is not significantly
altered but the random movement is suppressed, suggesting that cell
movements on a lam
Cochran G.V., Johnson M.W., Kadaba M.P., Palmieri V.R., and Mahaffey G.
(1987) Design considerations in development of a prototype, piezoelectric
internal fixation plate: a preliminary report. J. Rehabil. Res. Dev. 24, 39-50.
Abstract: The piezoelectric internal fixation plate represents a new concept in
orthopaedic implants. The purpose of this device is to provide stable bone
fixation while delivering internally generated, microampere direct currents to
prevent or treat nonunion of a fracture or osteotomy. Clinically, currents of this
type have been effective in treatment of nonunion, but application has
required separate, implanted, or external battery or radiofrequency powered
circuits. The "piezoplate" being developed contains an integral piezoelectric
element that generates current in response to either physiological loading
such as weightbearing or to externally applied ultrasound. Currents are
processed by a rectifying circuit for delivery to bone by electrodes. Specially
60
designed series/parallel piezoelectric elements and dual processing circuits
are required to generate optimum rectified currents from the low-frequency,
high-voltage signals generated by weightbearing, as well as the high-
frequency, low-voltage signals produced by ultrasound. This paper reports on
the current status of development and describes design parameters of this
device which combines the modalities of mechanical fixation and electrical
stimulation in a single implant
Collier J.H., Camp J.P., Hudson T.W., and Schmidt C.E. (2000) Synthesis and
characterization of polypyrrole-hyaluronic acid composite biomaterials for
tissue engineering applications. J. Biomed. Mater. Res. 50, 574-584.
Abstract: New tissue engineering technologies will rely on biomaterials that
physically support tissue growth and stimulate specific cell functions. The goal
of this study was to create a biomaterial that combines inherent biological
properties which
can specifically trigger desired cellular responses (e.g., angiogenesis) with
electrical properties which have been shown to improve the regeneration of
several tissues including bone and nerve. To this end, composites of the
biologically active polysaccharide hyaluronic acid (HA) and the electrically
conducting polymer polypyrrole (PP) were synthesized and characterized.
Electrical conductivity of the composite biomaterial (PP/HA) was measured by
a four-point probe technique, scanning electron microscopy was used to
characterize surface topography, X-ray photoelectron spectroscopy and
reflectance infrared spectroscopy were used to evaluate surface and bulk
chemistry, and an assay with biotinylated hyaluronic acid binding protein was
used to determine surface HA content. PP/HA materials were also evaluated
for in vitro cell compatibility and tissue response in rats. Smooth, conductive,
HA- containing PP films were produced; these films retained HA on their
surfaces for several days in vitro and promoted vascularization in vivo. PP/HA
composite biomaterials are promising candidates for tissue engineering and
wound-healing applications that may benefit from both electrical stimulation
and enhanced vascularization
Collier M.A., Kallfelz F.A., Rendano V.T., Krook L.P., and Schryver H.F. (1985)
Capacitively coupled electrical stimulation of bone healing in the horse: in vivo
study with a Salter type IV osteotomy model with stainless steel surface
electrodes. Am. J. Vet. Res. 46, 622-631. Abstract: The use of capacitively
coupled low-voltage signals for stimulation of osteogenesis has been reported
in a variety of animal models. Electrically induced osteogenesis was
investigated with a capacitively coupled electric field on a radius (distal-lateral
orientation) osteotomy model, in conjunction with internal fixation and
postoperative loading. Twelve adult horses of either sex were allotted to 2
groups of 6; 1 group was given electrical stimulation and the other served as
controls. A low-voltage high-frequency capacitively coupled electrical signal
was locally and continuously applied to the electrically stimulated group for 60
61
days through external, bare stainless steel surface electrodes which were
placed on the skin in circuit with a small, portable power source. Harness
compatibility and stimulator and battery durability were excellent. However,
stainless steel electrodes required a rigid maintenance schedule to maintain
consistent current levels. Synovial fluid evaluation demonstrated intra-
articular inflammation (decreased viscosity, hyaluronic acid, and increased
protein concentration) 1 week postoperatively that generally improved during
subsequent weeks and no distinction between groups was observed at 60
days. Radiographically, there was no difference in the appearance of the
healing process of control and that of stimulated horses during the 60 days.
Angiography showed bridging blood vessels in both groups. Uptake of a bone
seeking radiopharmaceutical peaked at 3 weeks in both groups and was 1.92
+/- 0.6 cps/pixel/mCi and 1.26 +/- 0.40 csp/pixel/mCi for control and
stimulated horses, respectively. At any given observation period, uptake in
the lesion area was greater in the control group. Ultimate strengths of
trabecular bone in 60-day control radii and stimulated radii were 12.64 +/-
3.013 and 9.60 +/- 3.95 MN/m2, and the flexural moduli of elasticity were
698.0 +/- 423 and 402.0 +/- 523 MN/m2, respectively. Porosity index was
similar for all specimens. Gross, histologic, and microradiographic evaluations
indicated that controls healed more efficiently than stimulated horses. A
capacitively coupled applied voltage of 2.2 V RMS (mean) producing a
current of 17.32 mA (mean) did not stimulate sufficient bone production in a
metaphyseal osteotomy model to affect the mechanical properties of the bone
or accelerate the healing process
Collier M.A., Brighton C.T., Norrdin R., Twardock A.R., and Rendano V.T. (1985)
Direct current stimulation of bone production in the horse: preliminary study
with a "gap healing" model. Am. J. Vet. Res. 46, 610-621. Abstract: The effect
of a 20-microA direct-current implantable bone growth stimulator (BGS) on
bone production with a "gap healing" model in the horse was evaluated. The
right and left 4th metatarsal bones (Mt-4) were used in 7 adult horses to
create the "gap healing" model. A 4-mm section of the Mt-4 bone was
resected bilaterally in each horse. The BGS was surgically placed into the 7
left Mt-4 defects. The 7 right Mt- 4 defects served as controls. Six horses
survived the 16-week experimental period. Signs of pain, decreased range of
limb motion, or lameness was not observed in any animal during the 16
weeks. None of the animals showed complete healing radiographically. Four
stimulated sites showed less periosteal reaction and 2 showed greater
reaction than the 6 controls. The greatest amount of periosteal reaction or
bone resorption was seen around the screws and plates in both groups.
Uptakes of 99mTc-MDP in counts/pixel for control sites and stimulated sites
were 7.90 and 8.25 in the "gap defect" and 5.19 and 5.06 in the areas
adjacent to the gap defect. The ratio of uptake between the gap defect and
adjacent area was 1.5 and 1.58 respectively. Biocompatability of the BGS
was excellent; however, 1 horse had a broken cathode wire 5 cm from the
generator capsule at 6 weeks. All polyethylene cathode sheaths were fluid
62
filled at 16 weeks. The average mineralization rates were 1.57 +/- 0.34, 1.71
+/- 0.28 mm/day and bone formation activity was 0.0182 +/- 0.171, and
0.0168 +/- 0.0149 mm2/day for control limbs and stimulated limbs,
respectively. There was no significant difference between groups in any of the
histomorphometric values measured. Direct current (20 microA) did not
increase bone production in this experiment. Methods to objectively evaluate
electrically induced osteogenesis and a "gap defect" model for BGS research
on the horse are discussed. The results provide a basis for additional
research on electrical stimulation of fractures in the horse and for dose-
response studies
Connolly J.F. (1981) Selection, evaluation and indications for electrical
stimulation of ununited fractures. Clin. Orthop. 39-53. Abstract: Management
of nonunions requires careful and critical assessment of the true biologic
status of the fracture. The mere radiographic persistence of a fracture line
does not invariably indicate nonunion. Ten percent of fractures considered
initially to be ununited in this series healed spontaneously without further
treatment. The patient who has no pain with weight-bearing and no
demonstrable motion on careful stress studies does not usually require further
treatment, except for protection against reinjury. Intraosseous venography
may be useful to distinguish the delayed from the nonunion in order to
institute appropriate and early treatment. Percutaneous direct-current
electrostimulation is proving to be a reliable and effective method of
managing the most common nonunion of the tibia or distal femur. It appears
less satisfactory for the more proximal femoral fractures and for fractures of
the humerus. Electrical stimulation does not eliminate the need to stabilize the
nonunion of either the femur or the upper limb. Electrical stimulation also
does not eliminate the need for bone grafting in approximately 15% to 20% of
nonunions. The fractures' biologic inability to respond may be identifiable by
99MTc diphosphonate bone scan. The implantable direct-current electrical
stimulatory device proved ineffective in this series. Hopefully, further
development of this technology may produce more consistent results in the
future. The electromagnetic noninvasive stimulator appears to be a useful
alternative method to the semi-invasive system. This, of course, should
depend on the individual needs of the patient and the nature and location of
the fracture. Continued technologic improvement in all electrical stimulatory
methods should broaden their usefulness and applicability. However, the
healing status of the fracture and the processes by which each fracture
responds must be carefully assessed to appreciate what is being effected by
electrical stimulation. Critical evaluation and clarification of indications are
essential if the patient is to be offered the most effective therapy available
Davis R., Houdayer T., Andrews B., and Barriskill A. (1999) Paraplegia:
prolonged standing using closed-loop functional electrical stimulation and
Andrews ankle-foot orthosis. Artif. Organs 23, 418-420. Abstract: One T10
63
paraplegic male (CS) implanted in 1991 with a Nucleus FES-22 stimulator
has been able to achieve closed-loop standing for 1 h. The knee angles are
monitored by electrogoniometers, resulting in the quadriceps stimulation time
being less than 10%. Stance stability is achieved by the Andrews anterior
ankle-foot orthosis (AFO). The use of accelerometers for trunk inclination and
vertical acceleration during controlled stand-to-sit, diminishes slamming onto
the seat. CS does one- handed tasks with objects of 2.2 kg. In another T10
paraplegic male (FR), surface stimulation was applied over 1.5 years to both
femoral nerves at the groin for conditioning and prolonged standing. With
quadricep conditioning, 55 Nm at 45 degrees of knee flexion is produced.
With the AFO and knee monitoring, FR can stand uninterrupted for up to 70
min and perform one-handed tasks. In August 1998, he was implanted with
the multifunctional Praxis FES 24-A stimulator for restoration of limb
movements, bladder and bowel function, and pressure sore prevention
Davis S.C. and Ovington L.G. (1993) Electrical stimulation and ultrasound in
wound healing. Dermatol. Clin. 11, 775-781. Abstract: The events that lead to
tissue repair are very complex. Because our understanding of these
processes is increasing in scope, the use of nontraditional treatment
therapies should be considered. Evidence is reported in the literature that
both electrical stimulation and ultrasound therapies may be beneficial in
certain circumstances to heal various wound types. Owing to clinicians'
unfamiliarity with the current research and general understanding of such
therapies, many patients receive only traditional treatment and remain
unexposed to the potential benefits of the nontraditional. With continued
research to better define optimal treatment parameters, improved wound
healing will result
Dayton P.D. and Palladino S.J. (1989) Electrical stimulation of cutaneous
ulcerations. A literature review. J. Am. Podiatr. Med. Assoc. 79, 318-321.
Abstract: The effect of electrical currents on living cellular systems has been
studied by many researchers and is becoming useful in clinical medicine.
Alteration of cellular activity with externally applied currents can positively or
negatively influence the status of a healing tissue, thereby directing the
healing process to a desired outcome. A review of the literature pertaining to
the effect of electrical currents on tissue healing is presented and the
relevance of this modality to ulcer healing is discussed
de Haas W.G., Lazarovici M.A., and Morrison D.M. (1979) The effect of low
frequency magnetic fields on the healing of the osteotomized rabbit radius.
Clin. Orthop. 245-251. Abstract: The object of this experimental work was to
evaluate the effect of a noninvasive method of electrical stimulation on the
healing of freshly- created
osteotomies of the rabbit radius. The apparatus consisted of a solid core
electromagnet energized by a square wave unidirectional current. The
64
magnetic field was pulsed transversely across the osteotomy site of the
radius while the animal was confined to a restraining device 6 hours daily for
5 days per week. In one group of animals the influence of different pulse
frequencies, using 0.1 Hz, 1 Hz, and 4 Hz, was evaluated, while the period of
stimulation was kept constant at 2 weeks. In another group of animals,
exposure was continued for 3 and 4 weeks while the pulse frequency was
kept constant at 1 Hz. Histologic and radiologic comparison with control
animals revealed that the initiation of the healing process can be accelerated
in magnetic fields pulsed at 1 Hz, but that this effect is not maintained, and
that the total period of time required for union is not significantly shortened. In
view of these findings, this form of treatment is not recommended for clinical
use in the treatment of recent fractures of long bones
de Haas W.G., Watson J., and Morrison D.M. (1980) Non-invasive treatment of
ununited fractures of the tibia using electrical stimulation. J. Bone Joint Surg.
Br. 62-B, 465-470. Abstract: A non-invasive method of electrical stimulation of
healing in ununited fractures of the tibia by pulsed magnetic fileds has been
evaluated. In a series of 17 patients all but two of the fractures united within 4
to 10 months, with an average time of just under six months. The method is
sufficiently promising to merit further clinical investigation
de Haas W.G., Beaupre A., Cameron H., and English E. (1986) The Canadian
experience with pulsed magnetic fields in the treatment of ununited tibial
fractures. Clin. Orthop. 55-58. Abstract: A clinical survey of 56 patients was
conducted at four different centers in Canada to evaluate the effect of
extremely low frequency pulsed magnetic fields (PMF) on ununited fractures
of the tibia. All ten patients with delayed union and 84% of the 44 patients
with nonunion healed. One case with a traumatic pseudarthrosis and one with
a congenital pseudarthrosis failed to respond to treatment. These results
compare favorably to those reported by others using a system with different
pulse characteristics. Prolonged immobilization is necessary and poses
problems of rehabilitation. Nonunions with a gap between the tibial fragments
and pseudarthroses are better treated with bone grafting and internal fixation
prior to electrical stimulation
Dunn A.W. and Rush G.A., III (1984) Electrical stimulation in treatment of
delayed union and nonunion of fractures and osteotomies. South. Med. J. 77,
1530-1534. Abstract: This study reviews the cases of 52 patients with 52
ununited fractures and osteotomies who were treated with two methods of
electrical stimulation, one surgical, the other nonsurgical. Seventeen patients,
14 of whom had concomitant bone grafting, had implantation of a bone
growth stimulator. There were three synovial pseudarthroses but no active
infection in this group. The overall success rate in healing of the fractures was
82%. Thirty-five patients, of whom four had initial concomitant bone grafting,
were treated with pulsing electromagnetic fields (PEMF). There were six
draining infections but no pseudarthrosis in this group. Two nonunions healed
after bone grafting was combined with PEMF treatment, when the latter alone
65
had failed. Eighty-one percent of the fractures united, and drainage ceased in
five of the six infections
Dunn M.G., Doillon C.J., Berg R.A., Olson R.M., and Silver F.H. (1988) Wound
healing using a collagen matrix: effect of DC electrical stimulation. J. Biomed.
Mater. Res. 22, 191-206. Abstract: Rapid fibroblast ingrowth and collagen
deposition occurs in a reconstituted type I collagen matrix that is implanted on
full- thickness excised animal dermal wounds. The purpose of this study is to
evaluate the effects of direct current stimulation on dermal fibroblast ingrowth
using carbon fiber electrodes incorporated into a collagen sponge matrix.
Preliminary results suggest that fibroblast ingrowth and collagen fiber
alignment are increased in collagen sponges stimulated with direct currents
between 20 and 100 microA. Maximum fibroblast ingrowth into the collagen
sponge is observed near the cathode at a current of 100 microA. These
results suggest that electrical stimulation combined with a collagen matrix
may be a method to enhance the healing of chronic dermal wounds
Enneking W.F., Eady J.L., and Burchardt H. (1980) Autogenous cortical bone
grafts in the reconstruction of segmental skeletal defects. J. Bone Joint Surg.
Am. 62, 1039-1058. Abstract: The results of using segmental cortical
autogenous bone grafts to reconstruct defects created by resection of tumors
were analyzed in forty patients. Thirty-three patients had dual grafts while
seven had a single fibular graft. Dual grafts were used for major bones
(humerus, femur, and tibia without fibula) while single grafts were used for the
radius and for the tibia when the ipsilateral fibula was intact. Thirty patients
had good or excellent results; seven, fair; and three, poor results. In twenty-
five patients primary union was achieved within tweleve months and in two, in
twenty months, while twelve patients required a second, supplementary
cancellous graft at the site of non- union to obtain stability. One patient
required removal of an infected graft and had a poor result. Stress fractures of
the grafts occurred in eighteen of the forty patients after union had occurred.
The stress fractures healed in fifteen of these patients: in six with no
treatment (the fracture was identified retrospectively), in seven with external
immobilization, and in two after bone-grafting of the ununited fracture. There
were three persistent non-unions of stress fractures despite bone-grafting,
internal fixation, and electrical stimulation, and these account for two of the
three poor results. The length of the defect did not affect the incidence of non-
union but it did affect the number of fatigue fractures. The shorter grafts (7.5
to twelve centimeters) were associated with a 33 per cent incidence of non-
union (four non-unions of twelve grafts) while the longer grafts (twelve to
twenty-five centimeters) had a 32 per cent rate of non-union (nine non- unions
of twenty-eight grafts). The incidence of fatigue fractures in the longer grafts
(58 per cent) was much greater than that in the shorter grafts (17 per cent).
The grafts decreased in density during the first six months but gradually
regained their mass and were generally comparable to normal cortical bone
at two years. As the patients became functiona, most (55 per cent) of the the
66
grafts became more dense than normal, some (34 per cent) remained the
same, and a few (11 per cent) became less dense. Similarly, some (32 per
cent) hypertrophied, most (58 per cent) remained the same size, and a few (9
per cent) atrophied. There was little morbidity (three of forty patients)
associated with graft procurement. In twelve patients an additional graft was
implanted experimentally, labeled with tetracycline, and subsequently
removed at the time of a secondary procedure. These grafts were analyzed to
determine if human grafts were repaired in the same fashion as grafts in
experimental animals. The studies showed that human grafts are repaired in
the same fashion, but that the sequence takes approximately twice as long as
it does in the dog
Enwemeka C.S. (1989) Inflammation, cellularity, and fibrillogenesis in
regenerating tendon: implications for tendon rehabilitation. Phys. Ther. 69,
816-825. Abstract: The initial three weeks of tendon healing were followed via
electron microscopy to elucidate the process of inflammation, fibrillogenesis,
and the cellular and subcellular events in tenotomized Achilles tendons, a
model that is commonly used to determine the biomechanical effects of
electrical stimulation, physical activity, ultrasound, and other forms of physical
therapy. The right Achilles tendons of 18 rabbits were tenotomized, sutured,
and immobilized. On each of postoperative days 5, 7, 12, 15, 18, and 21, the
right Achilles tendons of three experimental rabbits were excised and
processed for electron microscopy. To compare these tendons to normal
tendons, the Achilles tendons of three control rabbits were excised bilaterally
without prior tenotomy and processed for electron microscopy. Electron
micrographs thus obtained revealed 1) an initial period of inflammation lasting
at least five days, 2) a subsequent period of fibroplasia and fibrillogenesis,
and 3) a third period of progressive alignment and organization of the
collagen fibrils into bundles that were oriented in the longitudinal axis of the
tendon. Although healing in rabbits may not translate directly to healing in
humans, the findings of this study indicate that healing begins soon after
tenotomy and that the regenerating Achilles tendon undergoes different
stages of healing. Because each stage entails a different set of ultrastructural
events, therapeutic interventions should be modified to address the specific
events of each stage
Esterhai J.L., Jr., Brighton C.T., Heppenstall R.B., and Thrower A. (1986)
Nonunion of the humerus. Clinical, roentgenographic, scintigraphic, and
response characteristics to treatment with constant direct current stimulation
of osteogenesis. Clin. Orthop. 228-234. Abstract: Forty-six trauma patients
who had developed non-union of the humerus were evaluated from 1972
through 1981 as part of a large prospective study on nonunion. The average
age of the 46 patients was 55 years. Women outnumbered men (29 women
and 17 men). Seventy-one percent of the fractures occurred below the
midpoint of the humerus. Inadequate immobilization and/or distraction and
failure of internal fixation devices to obtain and maintain fracture fragment
67
contiguity and stability was noted. Of the 46 patients referred, 39 were treated
with constant direct current, using percutaneously inserted electrodes. Senile
and disuse osteoporosis (62%), synovial pseudarthrosis (42%), obesity
(20%), and osteomyelitis (5%) in this older patient population made this a
difficult treatment problem. Seventeen patients' nonunions healed (46%).
Electrical stimulation of nonunion of the humerus is not a panacea. Patient
selection is critical
Evans R.D., Foltz D., and Foltz K. (2001) Electrical stimulation with bone and
wound healing. Clin. Podiatr. Med. Surg. 18, 79-95, vi. Abstract: Electrical
stimulation has been used to heal fractures and ulcers and reduce pain
through modulation of local body processes. It has been recognized that
mechanical forces and bioelectricity have an intimate relationship in
influencing the production of bone. Science has developed techniques to
affect change in the electrical charge of fractures to positively affect the
healing process. Electrical stimulation, through invasive and noninvasive
applications, has produced excellent results in the treatment of nonunions
and ulcer care. A thorough review of the electrical properties of bone and soft
tissue and the influence of electrical stimulation on healing is presented here
Farkas L.G., Herbert M.A., and James J.S. (1980) Peritendinous healing after
early movement of repaired flexor tendon: anatomical study. Ann. Plast. Surg.
5, 298-304. Abstract: In 64 chickens the deep flexor tendon of the third toe
was divided and resutured, preserving the sheath and flexor sublimis tendon.
The leg was placed in a cast for 35 days postoperatively; in some birds
minimal flexion of the toes was induced by electrical stimulation of the deep
flexor muscle in the last 17 days of cast immobilization. At day 35 the cast
was removed, and the return of flexion carried out in the third toe was
measured up to day 60. Assessment of the tendon repair site was at 18, 35,
and 60 days. Restored peritendinous connections in specific areas were
similar to those in controls. Early movement resulted in fewer adhesions, a
significantly higher incidence of free intertendinous spaces (standard error of
difference = 6.3, difference = 14.5%), and significant lengthening of bridges
between the flexor profundus and phalanx (p = 0.01). The effect of early
movement gradually decreased from the dorsal to the ventral structures
Feedar J.A., Kloth L.C., and Gentzkow G.D. (1991) Chronic dermal ulcer healing
enhanced with monophasic pulsed electrical stimulation. Phys. Ther. 71, 639-
649. Abstract: The purposes of this randomized, double-blind, multicenter
study were to compare healing of chronic dermal ulcers treated with pulsed
electrical stimulation with healing of similar wounds treated with sham
electrical stimulation and to evaluate patient tolerance to the therapeutic
protocol. Forty-seven patients, aged 29 to 91 years, with 50 stage II, III, and
IV ulcers were randomly assigned to either a treatment group (n = 26) or a
control (sham treatment) group (n = 24). Treated wounds received 30 minutes
of pulsed cathodal electrical stimulation twice daily at a pulse frequency of
68
128 pulses per second (pps) and a peak amplitude of 29.2 mA if the wound
contained necrotic tissue or any drainage that was not serosanguinous. A
saline-moistened nontreatment electrode was applied 30.5 cm (12 in)
cephalad from the wound. This protocol was continued for 3 days after the
wound was debrided or exhibited serosanguinous drainage. Thereafter, the
polarity of the treatment electrode on the wound was changed every 3 days
until the wound progressed to a stage II classification. The pulse frequency
was then reduced to 64 pps, and the treatment electrode polarity was
changed daily until the wound was healed. Patients in the control group were
treated with the same protocol, except they received sham electrical
stimulation. After 4 weeks, wounds in the treatment and control groups were
44% and 67% of their initial size, respectively. The healing rates per week for
the treatment and control groups were 14% and 8.25%, respectively. The
results of this study indicate that pulsed electrical stimulation has a beneficial
effect on healing stage II, III, and IV chronic dermal ulcers
Ferguson A.C., Keating J.F., Delargy M.A., and Andrews B.J. (1992) Reduction
of seating pressure using FES in patients with spinal cord injury. A preliminary
report. Paraplegia 30, 474-478. Abstract: The aim of this study was to
investigate the use of functional electrical stimulation (FES) as a means of
pressure sore prevention in seated spinal cord injured (SCI) subjects. Nine
SCI subjects took part in tests in which electrical stimulation was applied to
the quadriceps with the lower legs restrained. Ischial pressures were
measured during periods of quiet sitting and FES application. A strain gauged
lever arm was used to measure the knee moment during quadriceps
stimulation. The average pressure drop at the right and left buttocks was 44
mmHg and 27 mmHg respectively. In general the greatest reductions
occurred in subjects with larger knee moments; however, there was no direct
relationship between the
pressure reduction obtained and the quadriceps strength. This form of FES may
be useful as a prophylactic aid in the management of pressure sores in SCI
subjects
Fitzgerald G.K. and Newsome D. (1993) Treatment of a large infected thoracic
spine wound using high voltage pulsed monophasic current. Phys. Ther. 73,
355-360. Abstract: This case report describes the use of electrical stimulation
with high voltage pulsed monophasic current for treatment of a large, infected
wound of the thoracic spine, following a surgical debridement procedure. The
patient was a 21-year-old man with spastic quadriplegic cerebral palsy who
was dependent for all self-care and was severely mentally retarded. The initial
wound size was as follows: length = 17 cm, top width = 7.5 cm, middle width
= 5.5 cm, bottom width = 2 cm, and depth = 5 cm. The wound was infected
with Staphylococcus aureus. The initial treatment consisted of 60 minutes of
electrical stimulation (20 minutes of negative polarity followed by 40 minutes
of positive polarity) once daily. The frequency of treatment was increased to
69
twice daily after 2 weeks. Total treatment duration was 10 weeks. The patient
received antibiotic treatment and daily nursing wound care in addition to
electrical stimulation treatment. The wound was completely closed after 10
weeks of treatment. The possible role of high voltage pulsed monophasic
current in accelerating the wound-healing process is discussed
Fleischli J.G. and Laughlin T.J. (1997) Electrical stimulation in wound healing. J.
Foot Ankle Surg. 36, 457-461. Abstract: The authors present a review of the
current literature regarding electrical stimulation with special focus on the
merits of its uses in wound healing. Literature from a basic science, animal
studies and clinical investigations are reviewed. The literature seems to
suggest that electrical stimulation can effect wound healing, but the method of
delivery remains uncertain
Fontanesi G., Traina G.C., Giancecchi F., Tartaglia I., Rotini R., Virgili B.,
Cadossi R., Ceccherelli G., and Marino A.A. (1986) Slow healing fractures:
can they be prevented? (Results of electrical stimulation in fibular
osteotomies in rats and in diaphyseal fractures of the tibia in humans). Ital. J.
Orthop. Traumatol. 12, 371-385. Abstract: The purpose of the study was to
evaluate the possibility of preventing delayed union in fractures by the use of
low-frequency pulsing electromagnetic fields (PEMFs). The study was
conducted in two parts, both with control groups. Fibular osteotomies in rats
and diaphyseal fractures of the tibia in humans were treated with and without
electrical stimulation (PEMF). The rats were sacrificed on the 8th and 23rd
days respectively in order to evaluate the histological picture of the repair
callus and its mechanical resistance. In the human subjects, the clinical and
radiological follow-up took into account various factors known to affect the
rate of union in the various fracture groups. The results obtained suggest that
PEMF stimulation is capable of accelerating and modulating the physiological
process of union by its favourable effect on osteogenesis
Forsted D.L., Dalinka M.K., Mitchell E., Brighton C.T., and Alavi A. (1978)
Radiologic evaluation of the treatment of nonunion of fractures by electrical
stimulation. Radiology 128, 629-634. Abstract: A procedure is described in
which nonunion of fractures is treated by implantation of electrodes with direct
electric current at the site of fracture. Of 107 patients treated with electrode
stimulation, 71 (66%) healed. If one eliminates 9 cases of congenital
pseudoarthrosis and 11 patients treated with only 10
microamperes of current, 70 of 87 patients (8095%) healed. Severe osteoporosis
and sclerosis were common radiologic findings, but had no value in predicting
which patients would respond to therapy
Frank C., Schachar N., Dittrich D., Shrive N., deHaas W., and Edwards G. (1983)
Electromagnetic stimulation of ligament healing in rabbits. Clin. Orthop. 263-
272. Abstract: To evaluate the effect of a specific noninvasive method of
70
electrical stimulation on ligament healing in rabbits, a solid core
electromagnet energized by a square wave unidirectional current was applied
to injured and repaired medial collateral ligaments seven hours per day, five
days per week for intervals of up to six weeks. Healing was evaluated by
gross, histologic, biochemical, and biomechanical parameters. Stimulation
was shown to increase histologic maturity relatively, restore stiffness and
failure strength earlier, and return collagen content toward normal unoperated
values sooner in these healing ligaments. It is uncertain whether the end point
of healing is affected by this technique, but at six weeks both histologic and
biochemical evidence of acceleration remains. Further investigation into the
effect of electromagnetic stimulation by this and other fields on non-osseous
tissues and their components is indicated
Frenzel P., Kleditzsch J., and Kienemund A. (1990) [A procedure for quantitative
roentgen image analysis for follow-up of Harrington scoliosis surgery]. Beitr.
Orthop. Traumatol. 37, 117-122. Abstract: A photometric procedure for
evaluating non-standardized X-ray films is described. The X-ray series of a
total of 23 patients operated on because of idiopathic scoliosis have been
measured out. In 16 patients Harrington's method with dorsal spondylodesis
was applied and in 7 patients an electrical stimulation with an implanted
stimulator was additionally employed. A time-saving effect of about 30 per
cent for the osseous consolidation is obtained by this method. The
fundamental suitability of the photometric procedure can be demonstrated
Fujita M., Hukuda S., and Doida Y. (1992) The effect of constant direct electrical
current on intrinsic healing in the flexor tendon in vitro. An ultrastructural study
of differing attitudes in epitenon cells and tenocytes. J. Hand Surg. [Br. ] 17,
94-98. Abstract: Light and electron microscopy were performed in a study of
the effects of electrical stimulation upon the reparative processes in flexor
tendons cultured in vitro. After one or two weeks of incubation, the
unstimulated control tendons were covered with fibroblastic surface cells,
thought to have originated from the epitenon. In contrast, the tendons
subjected to electrical stimulation had no proliferation of the epitenon cells in
the surface layer. The results indicate that electrical currents of low amperage
suppress adhesion-causing synovial proliferation in the epitenon and promote
active collagen synthesis in the tenocytes. This suggests the potential value
of electrical stimulation in the control of adhesion formation after flexor tendon
repair
Gardner S.E., Frantz R.A., and Schmidt F.L. (1999) Effect of electrical stimulation
on chronic wound healing: a meta- analysis. Wound. Repair Regen. 7, 495-
503. Abstract: The purpose of this meta-analysis was to quantify the effect of
electrical stimulation on chronic wound healing. Fifteen studies, which
included 24 electrical stimulation samples and 15 control samples, were
analyzed. The average rate of healing per week was calculated for the
electrical stimulation and control samples. Ninety-five percentage confidence
71
intervals were also calculated. The samples were then grouped by type of
electrical stimulation device and chronic wound and
reanalyzed. Rate of healing per week was 22% for electrical stimulation samples
and 9% for control samples. The net effect of electrical stimulation was 13%
per week, an increase of 144% over the control rate. The 95% confidence
intervals of the electrical stimulation (18- 26%) and control samples (3.8-14%)
did not overlap. Electrical stimulation was most effective on pressure ulcers
(net effect = 13%). Findings regarding the relative effectiveness of different
types of electrical stimulation device were inconclusive. Although electrical
stimulation produces a substantial improvement in the healing of chronic
wounds, further research is needed to identify which electrical stimulation
devices are most effective and which wounds respond best to this treatment
Gentzkow G.D. and Miller K.H. (1991) Electrical stimulation for dermal wound
healing. Clin. Podiatr. Med. Surg. 8, 827-841. Abstract: The investigations of
biologic actions (in vitro, animal, and human) demonstrated several effects
that help explain why electrical stimulation works. Based on the latest
scientific understanding of the wound healing process, one would expect that
a therapy that decreases edema, debrides necrotic tissue, attracts neutrophils
and macrophages, stimulates receptor sites for growth factors, stimulates
growth of fibroblasts and granulation tissue, increases blood flow, stimulates
neurite growth, induces epidermal cell migration, prevents postischemic
oxygen radical-mediated damage, inhibits bacteria, and reduces numbers of
mast cells ought to be beneficial for wound healing. Numerous human and
animal efficacy studies confirm that electrical stimulation of the proper charge,
density, and total energy causes dramatically improved healing of dermal
wounds. As of this writing, no devices have yet been approved by the FDA for
use in wound healing, although several devices approved for other indications
are being used for this purpose. One device (the Staodyn Dermapulse) has
undergone controlled animal and human testing, and an application
requesting approval for treating dermal ulcers has been submitted to FDA.
Taken together, the efficacy studies and the "mechanism of action" studies
provide compelling, scientific evidence that electrical stimulation is safe and
effective for promoting the healing of dermal wounds
Gentzkow G.D. (1993) Electrical stimulation to heal dermal wounds. J. Dermatol.
Surg. Oncol. 19, 753-758. Abstract: BACKGROUND. Numerous human and
animal efficacy studies have demonstrated that electrical stimulation of the
correct charge, density and total energy causes dramatically improved
healing of dermal wounds. The investigations of biological actions (in vitro,
animal, and human) demonstrate several effects that go a long way to
explaining why electrical stimulation works. OBJECTIVE. To discuss recent
research and advances in electrical stimulation of wound healing. RESULTS.
Based on the latest scientific understanding of the wound healing process,
one would expect a beneficial outcome from a therapy what decreases
72
edema, debrides necrotic tissue, attracts neutrophils and macrophages,
stimulates receptor sites for growth factors, stimulates growth of fibroblasts
and granulation tissue, increases blood flow, stimulates neurite growth,
induces epidermal cell migration, prevents post- ischemic oxygen radical-
mediated damage, inhibits bacteria, and reduces numbers of mast cells.
CONCLUSION. Taken together, the efficacy studies and the "mechanism of
action" studies provide compelling, scientific evidence that electrical
stimulation is safe and effective for promoting the healing of dermal wounds
Gilcreast D.M., Stotts N.A., Froelicher E.S., Baker L.L., and Moss K.M. (1998)
Effect of electrical stimulation on foot skin perfusion in persons with or at risk
for diabetic foot ulcers. Wound. Repair Regen. 6, 434-441. Abstract: The
failure of foot wounds to heal results in 54,000 people with diabetes having to
undergo extremity amputations annually. Therefore, treatment is needed to
speed healing in people with diabetes in order to reduce the need for
amputation. This study tested the effect of high- voltage pulsed current on
foot blood flow in human beings who are at risk for diabetic foot ulcers.
Neuropathy, vascular disease, Wagner Class, glucose, gender, ethnicity, and
age were measured. A sample of 132 subjects was tested using a repeated-
measures design. A baseline transcutaneous oxygen level was obtained;
stimulation was applied, and transcutaneous oxygen measurements were
recorded at 30- and 60- minute time intervals. The grouped foot
transcutaneous oxygen levels decreased (F = 5.66, p =. 0039) following
electrical stimulation. Analysis of variance (Scheffe, p <.05) showed that initial
transcutaneous oxygen was significantly higher than subsequent readings.
However, oxygen response was distributed bimodally: 35 (27%) subjects
showed increased transcutaneous oxygen (mean 14.8 mm Hg), and 97 (73%)
experienced a decreased transcutaneous oxygen reading (mean 12.2 mm
Hg). Logistic regression analysis did not explain these differences. Although
this treatment appears to increase blood flow in a subset of patients, further
study is needed to identify probable mechanisms for this response
Gogia P.P. (1996) Physical therapy modalities for wound management. Ostomy.
Wound. Manage. 42, 46-2, 54. Abstract: As part of a multidisciplinary team
approach to the management of chronic wounds, physical therapists can add
certain physical modalities to the care plan. Whirlpool, electrical stimulation,
ultrasound, low- energy laser and compression therapy are physical therapy
modalities that have been used to enhance wound healing. All of these
modalities are used as adjunct treatments that, when appropriate, may help
shorten the length of treatment and reduce patient suffering. Because the
efficacy of some of these modalities remains to be established in controlled
clinical trials, conventional wound care continues to be an important part of
the team approach
Goh J.C., Bose K., Kang Y.K., and Nugroho B. (1988) Effects of electrical
stimulation on the biomechanical properties of fracture healing in rabbits. Clin.
73
Orthop. 268-273. Abstract: One hundred fifteen white rabbits with an average
weight of 2.0 kg were used to study the influence of electrical stimulation on
osteogenesis. They were divided into three groups: Group I was electrically
stimulated with a constant direct current of 20 microamperes delivered to the
fracture site; Group II was the control group having the same protocol as
Group I except that the stimulator was not switched on; and Group III was the
normal fracture healing group (no introduction of electrodes to the fracture
site). Roentgenologic and histologic assessment showed that new bone
formation in the electrical stimulation group was more exuberant than those in
the other two groups in observation periods from three to eight weeks.
However, at 12 weeks no difference was observed among the three groups.
Biomechanical analysis showed definite increases in the breaking strength
and bending stiffness of the fracture healing tibia in Group I, especially at six
weeks after surgery. However, at 12 weeks no significant difference was
observed among the three groups. Therefore, electrical stimulation of fracture
healing has a positive effect
only at the midphase of the healing process, and it does not lead to faster
fracture healing
Gum S.L., Reddy G.K., Stehno-Bittel L., and Enwemeka C.S. (1997) Combined
ultrasound, electrical stimulation, and laser promote collagen synthesis with
moderate changes in tendon biomechanics. Am. J. Phys. Med. Rehabil. 76,
288-296. Abstract: The biomechanical, biochemical, and ultrastructural effects
of a multitherapeutic protocol were studied using regenerating rabbit Achilles
tendons. The multitherapeutic protocol was composed of low- intensity Ga:As
laser photostimulation, low intensity ultrasound, and electrical stimulation.
Achilles tendons of 63 male New Zealand rabbits were tenotomized, sutured,
immobilized, and subjected to the multitherapeutic protocol for five days, after
which casts were removed and the therapy was continued for nine more days
without electrical stimulation. The tendons were excised and compared with
control tendons. Multitherapy treatment produced a 14% increase in maximal
strength, a 42% increase in load-at-break, a 20% increase in maximal stress,
a 45% increase in stress-at-break, a 21% increase in maximal strain, and a
14% increase in strain-at-break. Similarly, multitherapy treatment was
associated with an increase in Young's modulus of elasticity of 31%, an
increase in energy absorption at maximum load of 9%, and an increase in
energy absorption at load-at-break of 11%. Biochemical analysis of the
tendons showed an increase of 23% in the total amount of collagen in the
multitherapy-treated tendons, with fewer mature crosslinks (decrease of 6%).
Electron micrographs revealed no ultrastructural or morphologic changes in
the tendon fibroblasts or in the extracellular matrix. The improvements
measured in tendons receiving multitherapy were consistent but less
remarkable compared with our earlier works with single modality protocols.
The results warrant the hypothesis that the beneficial effects of ultrasound
74
and laser photostimulation on tendon healing may counteract one another
when applied simultaneously
Gupta T.D., Jain V.K., and Tandon P.N. (1991) Comparative study of bone
growth by pulsed electromagnetic fields. Med. Biol. Eng Comput. 29, 113-
120. Abstract: Pulsed electromagnetic fields have been widely used for
treatment of non-united fractures and congenital pseudarthrosis. Several
electrical stimulation systems such as air-cored and iron-cored coils and
solenoids have been used the world over and claimed to be effective.
Electrical parameters such as pulse shape, magnitude and frequency differ
widely, and the exact bone-healing mechanism is still not clearly understood.
The study attempts to analytically investigate the effectiveness of various
parameters and suggests an optimal stimulation waveform. Mathematical
analysis of electric fields inside the bone together with Fourier analysis of
induced voltage waveforms produced by commonly used electrical stimulation
wave-forms has been performed. A hypothesis based on assigning different
weightings to different frequencies for osteogenic response has been
proposed. Using this hypothesis astonishingly similar effective values of
electric fields have been found in different systems. It is shown that effective
electric field rather than peak electric field is the main parameter responsible
for osteogenesis. The results are in agreement with experimental findings
made on human beings by different investigators
Guttler P., Kleditzsch J., and Schieche A. (1980) [The control of the effect of the
electrical stimulation for the callus formation by means of conductance
measurement in the rabbit tibia after osteotomy]. Z. Exp. Chir 13, 290-296.
Abstract: The measurement of the resistance between the electrodes for
stimulation during the operation shows the electrical field strength in the
osteotomie. This one will recommend for the comparison of the results of
stimulation experiments. The measurement in the course of healing shows
faults at the electrodes and the contacts, whereas as the assertions about the
process of healing are slightly
Han Z.F. and Zhang Y.C. (1985) [Electrical stimulation in promoting healing of
mandibular defects in the rabbit]. Zhonghua Kou Qiang. Ke. Za Zhi. 20, 32-4,
64.
Hanaoka T. (1983) [The effects of pulsed micro-electrical currents on internal
remodeling in long tubular bone and bone healing]. Nippon Seikeigeka
Gakkai Zasshi 57, 151-166. Abstract: The effects of pulsed micro-electrical
currents on internal remodeling in the cortex of long tubular bone were
evaluated by the following three experiments. 1. Electrodes were inserted in
both femora of 14 adult mongrel dogs, 15 mm apart, and pulsed micro-
electrical current was applied in the right femoral cortex for 4 weeks, but not
in the left femur, which was left as a control. Dogs were divided into 4 groups;
75
in each of these groups current with 1Hz-10 microA, 0.1 Hz-10 microA, 50
Hz-10 microA and 1Hz-20 microA was applied. The effects were evaluated by
histometric parameters, i.e. number of resorption cavities (Ar), osteons with
osteoid seam (osAf), mineralization rate of osteoid seam (Mo), and perimeter
of osteoid seam (Sf). Number of Ar and osAf increased. Bone formation rate
(Vf) which is the product of osAf, Mo and Sf increased, especially in the group
in which current with 1Hz-10 microA was applied. The main reason for
increase of Vf was considered due to that the activation frequency in internal
remodeling increased by electrical stimulation. 2. A metal plate was placed on
the right humerus, not on the left humerus, both femora of 5 dogs, and
electrical current of 1Hz-10 microA was applied in the right femur for either 12
or 16 weeks. Decrease of internal remodeling tended to take place in the mid-
portion of the plated area of femur, whereas Vf increased by pulsed micro-
electrical currents. Decrease of internal remodeling thus caused by placing a
plate and screws increased by pulsed micro- electrical current. 3. Number of
osteons in the newly formed bone in the osteotomized gap and in the cortex
adjacent to the gap of femora of 7 dogs, which were plated for either 4 or 6
weeks, was measured in longitudinal sections labelled by tetracycline. The
number of osteons increased more in the right femur in which current of 1Hz-
10 microA was applied than in the left femur. Based on the results above
described, it was concluded that bone healing was enhanced by pulsed
micro- electrical currents
Harris W.H., Moyen B.J., Thrasher E.L., Davis L.A., Cobden R.H., MacKenzie
D.A., and Cywinski J.K. (1977) Differential response to electrical stimulation:
a distinction between induced osteogenesis in intact tibiae and the effect on
fresh fracture defects in radii. Clin. Orthop. 31-40.
Haupt H.A. (1984) Electrical stimulation of osteogenesis. South. Med. J. 77, 56-
64. Abstract: The three electrical stimulation systems available for treating
nonunion of long bones are successful in approximately 85% of cases. The
percutaneous direct current bone growth stimulator is partially invasive,
allows patient mobility, can be used with magnetic fixation devices, and can
be monitored for proper function, but it requires an operation, cannot be used
where infection exists, and is subject to breakage. The implantable direct
current bone growth stimulator is similar, but is totally invasive. The external
pulsing electromagnetic field bone growth stimulator is
noninvasive and can be used where infection exists, but it requires long, exact
patient compliance and cannot be used with magnetic fixation devices or at
certain sites. None of the systems can be used where synovial pseudarthrosis
or a sizeable gap between bone ends exists, nor are they more effective than
bone grafting. Whether their use might evoke malignant transformation or
might accelerate or retard epiphyseal growth patterns is not known. Many
controlled studies are needed before it is clear how commonly electrical
stimulation should be used to treat bony ununion
76
Hellinger J. and Kleditzsch J. (1980) Electrical stimulation of the callus formation
by means of bipolar rectangular pulse sequences. Arch. Orthop. Trauma
Surg. 96, 241-246. Abstract: The clinical application of the electrical
stimulation, lasting several weeks, for the callus formation is reported in 11
patients. Bipolar rectangular pulse sequences were used for the stimulation at
a frequency of 1 Hz and a current intensity of +/-20mu amp. The electrical
stimulation was successfully employed after distraction osteotomies with a
KDA-apparatus in shortening of the leg provoked by different causes or in the
treatment of pseudarthroses. The realignment of the newly formed callus and
the osseous consolidation are stimulated and speeded up by the bipolar
rectangular pulse sequences as it is also shown in the light of the
roentgenograms of a case
Houghton P.E. and Campbell K.E. (1999) Choosing an adjunctive therapy for the
treatment of chronic wounds. Ostomy. Wound. Manage. 45, 43-52. Abstract:
Adjunctive therapies such as ultrasound, laser, ultraviolet light, superficial
heating, pulsed electromagnetic fields, and electrical stimulation have all been
indicated in the treatment of chronic wounds. The purpose of this article is to
outline the issues a healthcare professional must consider when choosing the
best adjunctive therapy for a chronic wound. It summarizes the effects of
therapeutic modalities on the wound healing process, analyzes the clinical
research evidence, discusses practical considerations, and reviews
indications, contraindications, precautions, and safety considerations. Finally,
an algorithm is presented to help guide the clinician in selecting a modality. In
summary, research evidence exists in the literature that suggests these
adjunctive therapies can directly stimulate new tissue growth, augment wound
tissue strength, improve local circulation and oxygenation, reduce edema,
and/or inhibit bacterial growth. Electrical stimulation and ultrasound are the
only therapeutic modalities that currently have sufficient clinical research
evidence to support their use in the treatment of chronic wounds. Practical
issues such as cost, time and training required, and patient and therapist
safety concerns, will ultimately influence the selection of these modalities
Il'inskii O.B., Lebedev V.P., Savchenko A.B., Solov'eva A.I., and Spevak S.E.
(1987) [Effect of transcranial non-invasive stimulation of the antinociceptive
structures of the brain on processes of repair]. Fiziol. Zh. SSSR Im I. M.
Sechenova 73, 223-229. Abstract: Transcranial electrical stimulation (AC +
DC) of antinociceptive brain structures causing the maximal analgetic effect
accelerated skin-wound healing in rats. The effect being completely blocked
with naloxone. Participation of opioidergic, antinociceptive brain structures in
wound healing and maintenance of structural homeostasis, is discussed
Jivegard L., Augustinsson L.E., Carlsson C.A., and Holm J. (1987) Long-term
results by epidural spinal electrical stimulation (ESES) in patients with
inoperable severe lower limb ischaemia. Eur. J. Vasc. Surg. 1, 345-349.
Abstract: Arterial reconstruction is the treatment of choice for patients with
77
severe lower limb ischaemia, but may at times be technically impossible.
Thirty-two consecutive patients with impending (n = 24) or already established
(n = 8) distal arteriosclerotic or diabetic lower limb gangrene, in whom
vascular surgery was either technically impossible or had failed, were treated
with epidural spinal electrical stimulation (ESES) for 27 +/- 16 (S.D.) months.
All patients had severe rest pain, which was reduced by ESES in 91% of the
cases. Improved ulcer healing was noted in 58% of the patients who had skin
ulceration. Eighty-three percent of those patients who did not have
established gangrene when ESES was started, retained their leg after 1 year,
and 54% after 3 years. These results suggest that ESES often provides pain
relief and improves skin healing in patients with impending arteriosclerotic or
diabetic gangrene in whom vascular surgery is impossible or has failed.
Epidural spinal electrical stimulation (ESES) does not affect the progression
of established gangrene but may provide pain relief. The observed outcome
of severe limb ischaemia in this study could be used to compare with those
after arterial reconstruction performed in patients with poor run-off vessels,
and may allow us to examine the natural history of this disease when
adequate pain relief is provided. The results reported here and the previously
reported enhancement of cutaneous blood flow in severely ischaemic
extremities by ESES may suggest, that ESES enhances limb salvage by
improving skin blood flow
Johnson E.E., Urist M.R., and Finerman G.A. (1992) Resistant nonunions and
partial or complete segmental defects of long bones. Treatment with implants
of a composite of human bone morphogenetic protein (BMP) and autolyzed,
antigen-extracted, allogeneic (AAA) bone. Clin. Orthop. 229-237. Abstract:
Twenty-five patients with resistant nonunions including partial or complete
segmental defects were treated with a composite alloimplant of human bone
morphogenetic protein (h-BMP) and autolyzed, antigen-free, allogeneic bone
(AAA). The series consisted of 16 females and nine males; average age was
45 years. Preoperative symptoms averaged 30 months (range, five to 83
months); 22 of 25 patients had failed multiple attempts at electrical
stimulation. Twenty-three of 25 patients had an average of three prior failed
surgical attempts at union (range, one to ten). There were ten segmental
defects with an average length of 4 cm (range, 2-9 cm). The composite
implant was incorporated as an onlay in 15 extremities and as an inlay graft
supported by internal fixation in ten extremities. Seven patients received
supplementary autogeneic cancellous bone grafting. Average healing time
was six months (range, three to 14 months). Average follow- up time was 21
months (range, five to 82 months). Functional results were rated as excellent,
14; good, five; and fair, five. One failed to unite because of a recurrent
infection. Union was obtained in 24 of 25 patients. There were five failures of
the original operation that required reoperations; union eventually occurred in
four of five extremities by repeat composite grafting and replacement of the
failed internal fixation. Bony union between host bone and the composite
implant began at an average of eight weeks postoperatively. Present results
indicate that h-BMP/AAA composite implants represent adjunctive treatment
78
of difficult nonunions. The h-BMP/AAA composite implants may be implanted
in either partial or complete segmental defects of long bones.(ABSTRACT
TRUNCATED AT 250 WORDS)
Jorgensen T.E. (1977) Electrical stimulation of human fracture healing by means
of a slow pulsating, asymmetrical direct current. Clin. Orthop. 124-127.
Abstract: Twenty-eight tibial fractures were treated with external fixation by
means of a Hoffmann apparatus. Through two electrode-screws in the
Hoffmann apparatus a slowly pulsating, asymmetrical direct current was
applied to the fracture site in each patient. The stimulated patients
experienced a 30 per cent acceleration in healing as determined by
mechanically stressing the Hoffmann apparatus used for immobilization of the
fracture
Kahanovitz N. and Arnoczky S.P. (1990) The efficacy of direct current electrical
stimulation to enhance canine spinal fusions. Clin. Orthop. 295-299. Abstract:
A prospective experimental study was devised to examine the effect of direct
current electrical stimulation on the healing of lumbar spinal fusions. Twelve
mongrel dogs had posterior facet fusion bilaterally at L1-L2 and L4-L5. A
direct current electrical stimulator was placed through each facet fusion. One-
half of the electrodes were functional, while the remainder served as controls.
Two animals were killed at two and four weeks, and four animals were killed
at six and 12 weeks, postoperatively. Each facet fusion was evaluated using
high-resolution roentgenograms and routine histology. In the two-, four-, and
six-week specimens, there was little difference in the roentgenographic or
histologic appearance of the control and stimulated fusions. However, by 12
weeks, all eight stimulated facet joints showed roentgenographic and
histologic evidence of solid bony fusion, but none of the eight control facet
joints demonstrated osseous bridging of the fusion site. The results of this
study suggest that direct current electrical stimulation appears to enhance the
bony union of facet fusions in the canine lumbar spine
Kahanovitz N. (1996) Spine update. The use of adjunctive electrical stimulation
to enhance the healing of spine fusions. Spine 21, 2523-2525. Abstract: The
use of electrical stimulation as an adjunct to enhance lumbar spinal fusion
continues to gain popularity. The different types of electrical stimulation and
their varying effects on posterior and anterior spinal fusion are discussed. The
selection of an electrical stimulation device should be based on the clinical
and experimental evidence of efficacy
Kambic H.E., Reyes E., Manning T., Waters K.C., and Reger S.I. (1993)
Influence of AC and DC electrical stimulation on wound healing in pigs: a
biomechanical analysis. J. Invest Surg. 6, 535-543. Abstract: To evaluate the
effects of electrical stimulation on the mechanical properties of healing skin,
20 Hanford mini-pigs weighing 10-15 kg with trochanteric pressure ulcers
were subjected to electrical stimulation. Examination of the biomechanical
79
properties of the skin and changes in wound area and volume was done on
previously wounded and healing pigskin subject to AC or DC electrical
stimulation. The behavior of normal pigskin was compared to (1) denervated
controls, (2) denervated AC-stimulated skin, and (3) denervated DC-
stimulated skin. A denervated limb trochanteric pressure sore model
developed in house permitted the use of a 6.5-mm percutaneous cancellous
screw for wound formation and a 3-cm-diameter spring compression indentor
to create reproducible and uniformly controlled grade 3 or higher tissue ulcers
in the monoplegic hind limbs. Denervation was accomplished by right
unilateral extradural rhizotomies from L2 to S1 nerve roots. Electrodes were
placed 1 cm distal and proximal to the wound periphery, and wounds were
stimulated 2 h/day, 5 days/week for 30 days. Dumbbell-shaped skin
specimens with a length to width ratio of 3:1 were uniaxially loaded in tension
until failure at an extension rate of 150 mm/min. The stiffness values for skin
samples oriented parallel to the current flow were reduced by nearly half the
values obtained for normal controls. Statistical differences (P < .05) were
found for stress, Young modulus, and stiffness when compared to normal
skin. Samples oriented in the perpendicular direction were comparable to
normal skin (P = NS).(ABSTRACT TRUNCATED AT 250 WORDS)
Kambic H.E., Reyes E., Manning T., Waters K.C., and Reger S.I. (1993)
Influence of AC and DC electrical stimulation on wound healing in pigs: a
biomechanical analysis. J. Invest Surg. 6, 535-543. Abstract: To evaluate the
effects of electrical stimulation on the mechanical properties of healing skin,
20 Hanford mini-pigs weighing 10-15 kg with trochanteric pressure ulcers
were subjected to electrical stimulation. Examination of the biomechanical
properties of the skin and changes in wound area and volume was done on
previously wounded and healing pigskin subject to AC or DC electrical
stimulation. The behavior of normal pigskin was compared to (1) denervated
controls, (2) denervated AC-stimulated skin, and (3) denervated DC-
stimulated skin. A denervated limb trochanteric pressure sore model
developed in house permitted the use of a 6.5-mm percutaneous cancellous
screw for wound formation and a 3-cm-diameter spring compression indentor
to create reproducible and uniformly controlled grade 3 or higher tissue ulcers
in the monoplegic hind limbs. Denervation was accomplished by right
unilateral extradural rhizotomies from L2 to S1 nerve roots. Electrodes were
placed 1 cm distal and proximal to the wound periphery, and wounds were
stimulated 2 h/day, 5 days/week for 30 days. Dumbbell-shaped skin
specimens with a length to width ratio of 3:1 were uniaxially loaded in tension
until failure at an extension rate of 150 mm/min. The stiffness values for skin
samples oriented parallel to the current flow were reduced by nearly half the
values obtained for normal controls. Statistical differences (P # .05) were
found for stress, Young modulus, and stiffness when compared to normal
skin. Samples oriented in the perpendicular direction were comparable to
normal skin (P = NS).(ABSTRACT TRUNCATED AT 250 WORDS)
80
Kernahan D.A. (1978) Muscle repair in unilateral cleft lip, based on findings on
electrical stimulation. Ann. Plast. Surg. 1, 48-53. Abstract: The appearances,
distribution, and direction of muscle in the unilateral cleft lip as indicated by
electrical stimulation are described. The findings differ from those reported by
Fara and associates in their dissections in that functionally the fibers do not
appear to parallel the margin of the cleft. Based on these findings, a method
of layer-by-layer, step-by-step closure of the unilateral cleft lip is described
that attempts to split the orbicularis bulge and advance the lateral muscle into
the philtrum to a position more nearly imitating the direction and extent of the
muscle in a normal lip
Khalil Z. and Merhi M. (2000) Effects of aging on neurogenic vasodilator
responses evoked by transcutaneous electrical nerve stimulation: relevance
to wound healing. J. Gerontol. A Biol. Sci. Med. Sci. 55, B257-B263. Abstract:
We have previously shown an age-related decline in the modulation of skin
vascular reactivity by sensory nerves that correlates with a decline in wound
repair efficacy. This study was designed to examine the possibility that
improving the functional ability of aged sensory nerves using noninvasive
transcutaneous electrical
nerve stimulation (TENS) could also accelerate tissue repair. TENS of the sciatic
nerve, combined with measuring blood flow responses in the rat hind-footpad
using laser Doppler flowmetry, was used to establish the vascular effects.
Following TENS (using parameters 20V, 5 Hz for 1 min), similar increases in
vascular responses were obtained in both young (13.2+/-0.9 cm2) and old
rats (11.6+/-2.3 cm2). In contrast, capsaicin-pretreated rats showed markedly
diminished responses. Sympathetic fibers did not appear to modulate these
sensory nerve responses. In the second part, a thermal wound was induced
(using a CO2 laser) in the interscapular region of old rats (under anesthesia).
In the active treatment group, TENS was applied twice daily for the initial 5
days, and the sham group received inactive TENS. Using the healing
endpoint as the time when full wound contraction occurred, the active group
required 14.7+/-0.2 days for complete healing, a significant improvement over
the sham group (21.8+/-0.3 days). We contend that low-frequency TENS can
improve the vascular response of old rats. In addition, wound healing in aged
rats can be accelerated by peripheral activation of sensory nerves at low-
frequency electrical stimulation parameters
Kloth L.C. and Feedar J.A. (1988) Acceleration of wound healing with high
voltage, monophasic, pulsed current. Phys. Ther. 68, 503-508. Abstract: The
purpose of this study was to determine whether high voltage electrical
stimulation accelerates the rate of healing of dermal ulcers. Sixteen patients
with stage IV decubitis ulcers, ranging in age from 20 to 89 years, participated
in the study. The patients were assigned randomly to either a Treatment
Group (n = 9) or a Control Group (n = 7). Patients in the Treatment Group
received daily electrical stimulation from a commercial high voltage generator.
81
Patients in the Control Group had the electrodes applied daily but received no
stimulation. The ulcers of patients in the Treatment Group healed at a mean
rate of 44.8% a week and healed 100% over a mean period of 7.3 weeks.
The ulcers of patients in the Control Group increased in area an average of
11.6% a week and increased 28.9% over a mean period of 7.4 weeks. The
results of this study suggest that high voltage stimulation accelerates the
healing rate of stage IV decubitis ulcers in human subjects
Kloth L.C. (1995) Physical modalities in wound management: UVC, therapeutic
heating and electrical stimulation. Ostomy. Wound. Manage. 41, 18-4, 26.
Abstract: In spite of efforts to create an optimum wound environment for
healing, there are times that a wound may not heal, may heal very slowly, or
may worsen. In these cases, a series of treatments with an appropriate
physical agent can be added to the patient's care plan to augment tissue
reparative processes. Three modalities that have received support in the
literature for use in wound healing are ultraviolet "C" radiation (UVC),
therapeutic heating, and electrical stimulation. Treatment goals for UVC are
hyperplasia and enhanced re- epithelialization or desquamation of the leading
edge of periulcer epidermal cells, granulation tissue formation, sloughing of
necrotic tissue, and bactericidal effects. Treatment goals for therapeutic
heating are increased blood perfusion with subsequent increased delivery of
oxygen to the tissues (avoiding the dessication of wound tissues). The
treatment goal for electrical stimulation is to attract negatively or positively
charged cells into the wound area, such as neutrophils, macrophages,
epidermal cells and fibroblasts that in turn will contribute to wound healing
processes by way of their individual cellular activities
Kloth L.C. and McCulloch J.M. (1996) Promotion of wound healing with electrical
stimulation. Adv. Wound. Care 9, 42-45.
Abstract: Clinicians involved in the conservative care of chronic wounds have
many treatment interventions from which to choose, including
debridement/irrigation, dressings, pressure-relieving devices, hyperbaric or
topically applied oxygen, whirlpool/pulsed lavage, ultrasound, topical
antibiotics, and cytokine growth factors. All except the last two interventions
are physical treatments that create a wound-tissue environment conducive to
healing. Unfortunately, many chronic wounds heal very slowly, do not heal, or
worsen despite the best efforts of caregivers to promote tissue repair. An
intervention commonly used to treat chronic wounds, especially by physical
therapists, is electrical stimulation (ES). The rationale for use of this method is
based on the fact that the human body has an endogenous bioelectric system
that enhances healing of bone fractures and soft- tissue wounds. When the
body's endogenous bioelectric system fails and cannot contribute to wound
repair processes, therapeutic levels of electrical current may be delivered into
the wound tissue from an external source. The external current may serve to
mimic the failed natural bioelectric currents so that wound healing can
82
proceed. Certain chemotaxic factors found in wound substrates contribute to
tissue repair processes by attracting cells into the wound environment.
Neutrophil, macrophage, fibroblast, and epidermal cells involved in wound
repair carry either a positive or negative charge. When these cells are needed
to contribute to autolysis, granulation tissue formation, anti-inflammatory
activities, or epidermal resurfacing, ES may facilitate galvanotaxic attraction
of these cells into the wound tissue and thereby accelerate healing
Kloth L.C. (1999) The APTA electrical stimulation lawsuit and its aftermath.
American Physical Therapy Association. Adv. Wound. Care 12, 472-475.
Kondo J. (1985) [Experimental histopathological studies of electrical callus
formation and mechanism of bone healing by direct micro-electrical current].
Nippon Seikeigeka Gakkai Zasshi 59, 803-817. Abstract: In order to get better
understanding of the effects of electrical stimulation on bone healing
processes, the author compared the healing processes of the femur in dogs
between two groups: a stimulation group and a control group (non-stimulation
group) which were experimentally prepared. These bone specimens were
periodically extirpated and used for pathological examinations and X-ray
micro-analysis. In the stimulation group, strong proliferation of osteoblasts
and new trabecular formation in the bone marrow were observed at the 3rd
day, and transition from fibrous to bony callus were noted at the 9th day; after
the 3rd week bone remodeling was sparsely seen and bone healing period
was shortened. In electromicroscopic observation, calcification of bone matrix
and bone remodeling also seemed to be facilitated in this group. However, no
marked differences in histological process of bone healing were observed
between the stimulation group and the control group
Lavine L.S. and Grodzinsky A.J. (1987) Electrical stimulation of repair of bone. J.
Bone Joint Surg. Am. 69, 626-630.
Litke D.S. and Dahners L.E. (1994) Effects of different levels of direct current on
early ligament healing in a rat model. J. Orthop. Res. 12, 683-688. Abstract:
Electrical stimulation has been shown to enhance the repair of biological
tissues such as bone and tendon. The objective of this study was to
determine whether low level direct current enhances the early healing of
injured medial collateral ligaments. Eighty-seven rats were divided into three
groups on the basis of
the level of current delivered. All underwent transection of the medial collateral
ligament bilaterally. The experimental medial collateral ligaments received
current (which varied by group), while the contralateral medial collateral
ligaments (the controls), with identical electrodes, received no current. After
12 days, each ligament was tested biomechanically with use of a hydraulic
materials testing machine. Group 1 (8.6 +/- 5.9 microA) showed statistically
significant improvements in maximum rupture force, energy absorbed,
83
stiffness, and laxity. The groups that had received lower levels of current did
not show significant improvements. In this study, stimulation of 1-20 microA
was the most effective level of direct current for the enhancement of early
healing of the medial collateral ligament
Lundeberg T.C., Eriksson S.V., and Malm M. (1992) Electrical nerve stimulation
improves healing of diabetic ulcers. Ann. Plast. Surg. 29, 328-331. Abstract: A
controlled study of the effects of electrical nerve stimulation (ENS) was
performed in conjunction with a standard treatment for healing chronic
diabetic ulcers on 64 patients divided randomly into two groups. All patients
received standard treatment (paste-impregnated bandage and a self-
adhesive elastic bandage) plus placebo ENS or ENS (alternating constant
current; frequency, 80 Hz; pulse width, 1 msec; intensity-evoking strong
paresthesias) for 20 minutes twice daily for 12 weeks. Comparison of
percentages of healed ulcer area and the number of healed ulcers was made
after 2, 4, 6, 8, and 12 weeks. There were significant differences (p < 0.05) in
both ulcer area and healed ulcers in the ENS group compared with the
placebo group after 12 weeks of treatment. The results of the present study
support the use of ENS in diabetic ulcers. ENS is easy to apply and can be
used by the patient at home following instructions from a medical doctor or a
therapist experienced in electrical stimulation and the treatment of ulcers.
Additional studies are needed to identify the mechanisms involved in the
promotion of ulcer healing with electrical stimulation and to determine the
stimulus variables that most efficaciously accelerate tissue repair
Mammi G.I., Rocchi R., Cadossi R., Massari L., and Traina G.C. (1993) The
electrical stimulation of tibial osteotomies. Double-blind study. Clin. Orthop.
246-253. Abstract: The effect of electromagnetic field stimulation was
investigated in a group of 40 consecutive patients treated with valgus tibial
osteotomy for degenerative arthrosis of the knee. All patients were operated
on by the same author and followed the same postoperative program. After
surgery, patients were randomly assigned to a control group (dummy
stimulators) or to a stimulated one (active stimulators). Four orthopedic
surgeons, unaware of the experimental conditions, were asked to evaluate
the roentgenograms taken 60 days postoperatively and to rate the osteotomy
healing according to four categories (the fourth category being the most
advanced stage of healing). In the control group, 73.6% of the patients were
included in the first and second category. In the stimulated group, 72.2% of
the patients were included in the third and fourth category. On a
homogeneous group of patients, electromagnetic field stimulation had positive
effects on the healing of tibial osteotomies
Marino A.A., Gross B.D., and Specian R.D. (1986) Electrical stimulation of
mandibular osteotomies in rabbits. Oral Surg. Oral Med. Oral Pathol. 62, 20-
24. Abstract: The use of electrical stimulation to accelerate mandibular
healing was studied in rabbits that had undergone bilateral mandibular slot
84
osteotomies. Stimulation on the day of surgery and for 3 successive days
thereafter (2 hours per
day) produced accelerated healing as evaluated histologically 8 days after
surgery. Stimulation during the entire postoperative period did not result in
accelerated healing. Intermittent stimulation in the early postoperative period
may be clinically useful for accelerating the healing of mandibular fractures
Masureik C. and Eriksson C. (1977) Preliminary clinical evaluation of the effect of
small electrical currents on the healing of jaw fractures. Clin. Orthop. 84-91.
Abstract: A clinical investigation has been carried out into the effect of small
electrical currents on the healing of mandibular fractures. Electrical
stimulation of fracture healing was carried out in 40 patients with a direct
current of 10 or 20 microamperes delivered through a platinum electrode. An
equal number of patients with similar fractures were selected as controls.
Rate of repair was assessed by measuring the mobility of the fracture. Serum
phosphatase and calcium were regularly measured at intervals in both groups
after reduction and suggested that alkaline phosphatase activity increased in
the stimulated group. The repair process was enhanced in the electrically
stimulated fractures compared to the controls in the first 10-14 days after
reduction
Mawson A.R., Siddiqui F.H., and Biundo J.J., Jr. (1993) Enhancing host
resistance to pressure ulcers: a new approach to prevention. Prev. Med. 22,
433-450. Abstract: Pressure ulcers are notoriously common in spinal-cord-
injured patients, in patients with other neurological deficits, in malnourished
and severely debilitated patients, and in the frail elderly. Prolonged localized
external pressure, coupled with insensitivity to ischemia resulting from
neurologic injury, has long been considered the major causal factor.
Preventive efforts have focused on the relief of pressure via frequent
repositioning and the use of pressure-relieving devices. However, consensus
is growing that host factors also play a role in the development of pressure
ulcers, the most important in spinal-cord-injured patients being the injury-
induced loss of vasomotor control below the level of the lesion, resulting in
hypoxemia. Accordingly, pressure ulcers may be prevented not only by
reducing external pressure but also by increasing the patient's resistance to
pressure, that is, by directly influencing tissue oxygenation. Review of the
literature suggests that electrical stimulation increases cutaneous blood flow
and promotes the healing of pressure ulcers. Moreover, high-voltage pulsed
galvanic stimulation (75 V, 10 Hz) applied to the back at spinal level T6 in
spinal-cord-injured persons lying supine on egg-crate mattresses can raise
sacral transcutaneous oxygen tension levels into the normal ranges (A. R.
Mawson, F. H. Siddiqui, B. J. Connolly, C. J. Sharp, W. R. Summer, and J. J.
Biundo, Jr., Paraplegia in press). Randomized controlled trials are needed to
determine the efficacy of high-voltage pulsed galvanic stimulation for
85
preventing pressure ulcers in spinal-cord-injured persons and other groups at
high risk
McCulloch J.M. (1998) The role of physiotherapy in managing patients with
wounds. J. Wound. Care 7, 241-244. Abstract: The physiotherapist is a highly
respected member of the wound-care team in the USA. While assisting in all
aspects of wound care, including debridement and dressing selection and
application, the physiotherapist also provides a unique function. The
numerous physical agents, such as electrical stimulation, ultrasound,
hydrotherapy and heat all have benefits to offer the patient in contributing to
healing. The background knowledge of biomechanics possessed by members
of this discipline likewise enhances the services of the wound-care team.
Physiotherapists
recommend strategies to relieve or redistribute pressure for those confined to
bed or wheelchair or for the ambulatory individual with an insensate foot. It is
perceived that physiotherapists who remain uninvolved in wound care are a
major untapped resource with great potential for promoting wound healing
McElhannon F.M., Jr. (1975) Congenital pseudarthrosis of the tibia. South. Med.
J. 68, 824-827. Abstract: Congenital pseudarthrosis of the tibia is a rare and
difficult problem. The cause is unknown, the treatment is nonstandardized,
and the results are generally poor. One or two good attempts at union should
be made, followed by amputation if union is not obtained or if deformity is
worse than that produced by a prosthesis. Electrical stimulation of bone
healing is not yet technically advanced enough for use in stimulating fractures
to heal in humans, but it has been proven to promote healing in animals and
holds considerable promise for the future
McLachlan C.S., Jelinek H.F., Kummerfeld S.K., Rummery N.M., Jusuf P.R.,
Hambly B., and McGuire M.A. (2000) Cross-sectional infarct edge jaggedness
does not influence ventricular electrical stability in a rabbit model of late
myocardial infarct healing. Redox. Rep. 5, 122-123. Abstract: Previous
studies have suggested that the jaggedness of the healed or healing infarct
edge influences cardiac electrical stability. However, these findings have
been based on histological observations rather than quantitative
measurements. The aim of this study was to assess infarct jaggedness by
calculating its fractal dimension and to examine how this influences cardiac
electrical stability during late infarct healing in the rabbit. Using programmed
electrical stimulation, it was found that the fractal dimension did not differ
significantly in 19 rabbits that had inducible ventricular tachycardia and 16
that did not. We conclude from these studies in the mature rabbit that infarct
edge jaggedness does not influence the ease with which ventricular
tachycardia is induced during late myocardial infarct healing
86
Miller G.J. (1983) Experience with electrical stimulation of nonunions. Bull. Hosp.
Jt. Dis. Orthop. Inst. 43, 178-186. Abstract: The use of electrical stimulation
modalities for the treatment of nonunions in the orthopaedic patient
population is receiving increasing attention. The following report briefly
describes the early results obtained from using three commercially available
devices in 33 patients
Moriya M. and Tanaka H. (1990) [Experimental study on the application of direct
current to the intra- osseous implant]. Nippon Hotetsu. Shika. Gakkai Zasshi
34, 309-317. Abstract: The purpose of this study is to investigate the effect of
the direct current electrical stimulation on surrounding tissue of the intra-
osseous implant. The implant was composed of a peripheral hydroxyapatite
layer and a central metal which was used as electrodes, and applied 10
microA constant direct current. They were implanted in femurs of four guinea
pigs. These results were as follows: 1. When the bone marrow is stimulated
electrically with 10 microA direct current for 28 days, large amount of bone
formation around the implant was seen in wide area. 2. There was a different
reaction surrounding tissue between cathode and anode. Around the cathode,
bone formation on the surface of the implant was recognized remarkably.
Around the anode, little amount of bone formation on the surface of the
implant was
recognized. 3. The electrical stimulation, with newly developed power unit and
electrode, accelerated new bone formation
Morykwas M.J. and Argenta L.C. (1997) Nonsurgical modalities to enhance
healing and care of soft tissue wounds. J. South. Orthop. Assoc. 6, 279-288.
Abstract: The rapidly aging population and patients with multiple concomitant
pathologies present an increasing population of patients with nonhealing and
problem wounds causing an unwelcome challenge for all health care
providers. Many of these patients are not surgical candidates, or surgical
procedures have failed to close their wounds. These wounds are particularly
worrisome when an orthopaedic component is included, since bone and
hardware must be covered as quickly as possible to prevent infection and
even worse complications. We present a brief overview of several nonsurgical
modalities that may be used to heal soft tissue wounds completely or to
prepare the wound so a smaller surgical intervention may be done with
greater chance for success. We include exogenous application of growth
factors, cultured keratinocyte grafts, electrical stimulation, hyperbaric oxygen,
and a vacuum- assisted closure system (V.A.C.)
Nath C. and Gulati S.C. (1998) Role of cytokines in healing chronic skin wounds.
Acta Haematol. 99, 175-179. Abstract: In the chronic wound, the normal
cascade of inflammation, granulation and reconstruction phases of healing is
interrupted. Cytokines are now known to orchestrate different biochemical
mediators resulting in the restoration of the healing phases. Growth factors
87
may play a significant role in stimulating wound repair by stimulating growth
and proliferation. Since growth factors stimulate a variety of functions
depending on cell type and wound stage and since wound-healing defects
may occur at any phase of healing, a mixed combination of growth factors
would be predicted to be more effective than a single factor. Factors that may
modulate the action of growth factors include electrical stimulation, weight
bearing, debriding and ischemia
Nessler J.P. and Mass D.P. (1987) Direct-current electrical stimulation of tendon
healing in vitro. Clin. Orthop. 303-312. Abstract: The intrinsic capacity of
tendons to heal in response to injury has recently been demonstrated by
many investigators. Electrical stimulation is often assumed to augment
regeneration of various tissues. Using newly developed methods of whole-
tendon culture, the authors examined the effect of direct-current electricity on
healing in vitro. Deep flexor tendons of rabbits were excised, transected,
repaired, and grown in an acellular culture medium for seven, 14, 21, or 42
days. Tendons through which a continuous 7-microAmp current was passed
at the repair site were compared with nonstimulated controls. The
incorporation of (14C)proline and its conversion to (14C)hydroxyproline was
measured at seven days. The mean (14C)proline and (14C)hydroxyproline
activities were 91% and 255% greater, respectively, in the stimulated group.
The activity was also higher in the stimulated group, by 42 days. Histologic
sections showed that intrinsic tenoblastic repair may be enhanced with
electrical stimulation in vitro
Ni R.X. (1982) [Augmentation of bone repair by electrical stimulation: experiment
and clinical observation (author's transl)]. Zhonghua Wai Ke. Za Zhi. 20, 103-
105.
O'Malley T.J. (1992) A review of the functional electrical stimulation equipment
market. Assist. Technol. 4, 40-45. Abstract: The market for functional
electrical stimulation (FES) equipment for use in rehabilitation is growing as
increasingly sophisticated products enter the market each year. Factors that
impact the availability of FES equipment include technological limitations,
government regulation, reimbursement status, and clinician training. New
products have become available in the last decade with many innovative
applications available under investigational status. The current availability of
FES equipment for selected applications such as therapeutic muscle
stimulation, cardiovascular exercise, restoration of function in the lower and
upper extremities, respiratory assist, restoration of bladder function,
electroejaculation, and scoliosis correction is reviewed. A review of FES
equipment for nonneuromuscular applications such as control of epilepsy,
cochlear implants, electrotactile stimulation, and systems to enhance wound
healing and bone growth is also included. Key manufacturers are identified
88
Okada Y. and Shiba R. (1984) [The relationship between electrical callus
formation and the amount of electricity]. Nippon Seikeigeka Gakkai Zasshi 58,
1013-1023. Abstract: Electrical stimulation to enhance callus formation has
been in use for some time now. This experiment was undertaken to find the
relationship between electrical callus formation and the amount of electricity.
In this experiment, the long bones of canines were stimulated by direct
current and observed microscopically for callus formation. Moreover,
distribution patterns of electric potential and current density were calculated
theoretically by finite element method. The results are summarized as follows:
Electrical callus formation was observed in the medullary canal with 8.7-20
microA direct current. Electrical callus is fibrous ossification and the peak of
callus formation is from fourteen to twenty one days. There is no difference in
volume and/or speed of callus formation between the simple and the constant
direct current. Using platinum electrodes, the amount of callus formed around
the cathode and anode is the same. To prevent electrolysis of the tissues,
distance between electrodes must be kept at a minimum. On the other hand,
the surface area of the electrodes must be widen to keep the electric potential
at the minimum level. The area of callus formation is related to 5-10
microA/cm2 of electric current density
Osterman A.L. and Bora F.W., Jr. (1986) Electrical stimulation applied to bone
and nerve injuries in the upper extremity. Orthop. Clin. North Am. 17, 353-
364. Abstract: In conclusion, electrical stimulation of bone has advanced from
the laboratory to clinical reality. Despite the lack of good double-blind clinical
studies, it is impossible to ignore the excellent results reported from
numerous multicenter trials. Doubts and controversies will and should
continue. Electrical stimulation has a definite place in the treatment of
scaphoid nonunion as well as other failures of osteogenic biology in the upper
extremity. The future may realize the enormous potential of electrical
stimulation in areas of nerve repair, wound healings, or osteoporosis. The
hand surgeon may soon be operating in the age of biophysics where he or
she can charge by the kilowatt hour. Yet one should not become a mere
technician, but understand the basic science of what one is doing and, above
all, maintain a balanced and critical approach
Paterson D.C., Carter R.F., Maxwell G.M., Hillier T.M., Ludbrook J., and Savage
J.P. (1977) Electrical bone-growth stimulation in an experimental model of
delayed union. Lancet 1, 1278-1281.
Abstract: An experimental model has been devised for the consistent production
of delayed bone healing of the tibia in adult dogs. A double-blind trial, with
bias eliminated, was used to evaluate the use of a commercially available
direct-current bone-growth stimulator with this model. The stimulator
produced a statistically significant acceleration of bone healing at four weeks
in the experimental model. Osteogenesis was normal, and no dysplastic,
inflammatory, or neoplastic changes were found. This research has shown
89
that electrical stimulation of bone is safe and augments bone formation. The
bone-growth stimulator unit remains on trial, but in future it may alter the
management of many difficult orthopaedic problems
Paterson D.C., Hillier T.M., Carter R.F., Ludbrook J., Maxwell G.M., and Savage
J.P. (1977) Experiemtnal delayed union of the dog tibia and its use in
assessing the effect of an electrical bone growth stimulator. Clin. Orthop. 340-
350. Abstract: A technique has been described for the consistent production
of delayed bone healing of the tibia in an animal model. A controlled double
blind trial, where independent observors did not know the coding of the
stimulators and did not collaborate with each other, has evaluated the use of
a direct current bone growth stimulator in such an animal model. The
conclusion of the experiment is that this commercially available direct current
stimulator does produce a significant acceleration of bone healing at 4 weeks
in the experimental model used. There is no evidence of inflammatory or
neoplastic changes. The eventual clinical role of electrical bone stimulation
remains uncertain and many questions remain unanswered, but are
promising enough to encourage a controlled clinical trial in situations of
disturbed bone healing. Electrical stimulation is apparently safe and appears
to significantly augment bone formation. A controlled clinical trial is now being
carried out in major medical centers in Australia
Paterson D.C., Carter R.F., Tilbury R.F., Ludbrook J., and Savage J.P. (1982)
The effects of varying current levels of electrical stimulation. Clin. Orthop.
303-312. Abstract: An effort has been made to find an experimental delayed
union of a long bone that could be used to evaluate the osteogenic effect of
different current strengths. It is important that the optimum current strength be
determined. Any such model should be able to produce a difference in new
bone formation with an active and an inactive stimulator, particularly one
using a 20 microA direct current. Attempts to produce a nonunion model in
dogs were unsatisfactory, possibly because the defect was too small and
surrounded by normal bone, and excessive movement occurred at the
cathode plate. The optimum range of electrical stimulation using a titanium
cathode has not been established by this work. The changes in serum
alkaline phosphatase, serum calcium and serum phosphorus concentrations
in response to trauma have been shown to be the same in the bone formation
induced by electrical current
Petersson C.J. and Johnell O. (1983) Electrical stimulation of osteogenesis in
delayed union of the rabbit fibula. Arch. Orthop. Trauma Surg. 101, 247-250.
Abstract: The present paper describes an experimental model where union
was delayed in an osteotomy gap of the rabbit fibula by means of a silicone
rubber spacer during 48 days. After the silicone spacer had been removed,
electrical transistor regulated direct current of 20 microamperes delivered
through stainless steel electrodes was used to stimulate osteogenesis on the
right side during 62 days. On the left side a sham operation inserting stainless
90
steel electrodes without current was performed. In one out of six animals
overbridging callus was received on the
stimulated side. In the rest of the animals a high frequency of synostoses
between the fibular ends and the tibia was found. There was no significant
difference in synostosis formation between the right and the left side. No
adverse effect of the current could be detected histologically
Piekarski K., Demetriades D., and Mackenzie A. (1978) Osteogenetic stimulation
by externally applied dc current. Acta Orthop. Scand. 49, 113-120. Abstract: A
new, simple, safe and noninvasive technique for the electrical stimulation of
fracture healing is introduced. The safety and the simplicity of the technique
makes it possible to apply it almost immediately to clinical experimentation.
Electrodes were applied externally to the fractured site producing current
across the limb. It was observed that the current density changes the volume
of callus and affects the direction of the trabecular orientation. When the
trabecular orientation is completely changed from longitudinal to transverse,
the larger volume of callus does not compensate for the loss of strength as
compared with the callus on the control bone
Polak A., Franek A., Hunka-Zurawinska W., Bendkowski W., Kucharzewski M.,
and Swist D. (2000) [High voltage electrical stimulation in leg ulcer's
treatment]. Wiad. Lek. 53, 417-426. Abstract: The results of leg ulcers
treatment in two comparative groups, A and B, are presented in the article. In
the group A 22 patients with leg ulcers were treated with the use of high
voltage electrical stimulation. In the group B 20 patients with leg ulcers were
treated actively with the use of traditional methods. The average time of
treating patients subjected to electrical stimulation was 7 weeks and in the
control group the average time of treatment was 6 weeks. The healing
progress was estimated on the basis of rate of wounds surfaces and volumes
changes per week and their proportional changes. In the group A the average
rate of ulcer surface decreasing was 1.4 cm2 per week and the average
volume diminishing in this group was 1.0 cm2 per week. These indicators in
the group B were respectively 1.0 cm2 and 0.6 cm3. In the group A wound
surface decreased by 73.4% during the treatment and wound volume by
91.3%. In the group B these indicators were respectively 46.9% and 67.6%.
After the treatment all indicators estimating the progress of wound healing in
the groups A and B proved the statistically significant increases. The
proportional indicators of wounds surfaces and volumes were significantly
higher in the group A than in the group B
Reger S.I., Hyodo A., Negami S., Kambic H.E., and Sahgal V. (1999)
Experimental wound healing with electrical stimulation. Artif. Organs 23, 460-
462. Abstract: The effect of alternating current (AC) and direct current (DC)
stimulation was studied on experimental pressure ulcer healing in a new
monoplegic pig model. The study was conducted in 30 healthy young Hanford
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minipigs. The rate of wound healing, histology, vascularization, collagen
formation, microbiology, perfusion, and the mechanical strength of the healed
wounds were studied. Normal pigskin was compared to denervated control
and denervated AC and DC stimulated healed skin. Hind limb denervation
was by right unilateral extradural rhizotomies from the L2 to S1 nerve roots.
Reproducible uniformly controlled Stage III or higher tissue ulcers were
created. When compared to the control wounds, both the AC and DC
stimulated wounds showed reduced healing time and increased perfusion in
the early phases of healing. DC stimulation reduced the wound area more
rapidly than AC, but AC stimulation reduced the wound volume more rapidly
than DC. The
electrical stimulation did not reduce the strength of the healing wounds below
those of the nonstimulated controls. The applied current appears to orient
new collagen formation even in the absence of neural influences
Reich J.D., Cazzaniga A.L., Mertz P.M., Kerdel F.A., and Eaglstein W.H. (1991)
The effect of electrical stimulation on the number of mast cells in healing
wounds. J. Am. Acad. Dermatol. 25, 40-46. Abstract: Many cutaneous
disorders are associated with activation or increased numbers of mast cells.
Electrical stimulation has been shown to be effective in treating many of these
disorders. This study is designed to examine the effect of electrical
stimulation on mast cells in acute wounds. Four pathogen-free pigs received
20 wounds, each of which was subjected to biopsy at various times after
wounding. Half of the wounds were treated with electrical stimulation and the
other half were treated with a sham electrode. The biopsy specimens were
fixed in Carnoy's medium and stained with alcian blue and Nuclear Fast Red.
Mast cells from both sets of wounds were counted and analyzed. Highly
significant reductions in the number of mast cells were seen with electrical
stimulation on days 1 and 2 compared with nonstimulated control wounds.
Electron microscopy was performed to compare the stimulated and control
mast cells for characteristic features in morphology, location, and evidence of
degranulation. Electrical stimulation did not appear to induce degranulation.
The ability of electrical stimulation to decrease the number of mast cells may
be related to a reduction of either proliferation or migration of these cells and
may prove to be a valuable therapeutic technique
Reswick J.B. and Simoes N. (1975) Application of engineering principles in
management of spinal cord injured patients. Clin. Orthop. 124-129. Abstract:
Engineering services currently being used for spine stabilization, respiratory
assist, and pressure sore prevention are discussed as well as devices under
development for bowel and bladder control, reduction of contractural
deformities and spasticity, and electrical stimulation of paralyzed muscles.
Concepts and devices for improved function are divided into categories of:
orthotic devices; environmental control systems; mobility systems; page-
92
turning devices. A wide range of engineering devices are available but strict
attention must be given to medical rationale for their use
Rinaldi R., Shamos M., and Lavine L. (1974) Uptake of tritiated thymidine during
electrical stimulation of induced cortical bone defects. Ann. N. Y. Acad. Sci.
238, 307-313.
Rogerson A.R., Clark K.F., Bandi S.R., and Bane B. (1996) Voice and healing
after vocal fold epithelium removal by CO2 laser vs. microlaryngeal stripping.
Otolaryngol. Head Neck Surg. 115, 352-359. Abstract: Controversy exists
regarding voice recovery after the use of laser vs. microforceps techniques in
the removal of benign vocal fold lesions. The purpose of this study is to
compare recovery of voice and healing between groups of cats undergoing
vocal fold epithelium removal by CO2 laser and those having vocal fold
stripping. Fourteen adult female cats underwent standardized unilateral vocal
fold injuries by CO2 laser ablation or stripping. After a 6-week recovery
period, phonations were evoked by electrical stimulation of the midbrain
periaqueductal gray area. Phonations were recorded for acoustic analysis.
The larynges were harvested, fixed, and sectioned for histologic correlation.
Acoustic analysis showed the mean
signal-to-noise ratios in the laser group (19.72) to be significantly higher than
those in the stripped group (13.51) (p = 0.04). The stripped group showed
significantly greater amplitude perturbation (8.68% vs. 2.43%, p = 0.02). No
between-group difference was found for period perturbation. Histologically,
the laser group showed minimal Reinke's space scarring and near-normal
epithelial regeneration, and the stripped group showed marked subepithelial
scarring, often involving the vocalis muscle. These results demonstrate
superior recovery of voice and healing in animals undergoing vocal fold
epithelium removal with the CO2 laser. Inferior outcomes seen in the stripped
group may be related to difficulty in preserving Reinke's space during
epithelium removal
Romanko K.P. (1991) Pressure ulcers. Clin. Podiatr. Med. Surg. 8, 857-867.
Abstract: Progress in treatment of pressure ulcers over the past decade has
contributed to our ability to more effectively treat problem ulcers. Through
choice of the proper dressing, wound environment and cellular activity may be
positively influenced and wound repair accelerated. Electrical stimulation,
biologic implants, and growth factors are advanced forms of treatment that
will become more accessible during the 1990s. Despite all the progress
made, one must remember that these modalities are not substitutions for the
care necessary to prevent the occurrence of pressure ulcers. Appropriate
care and knowledge of available products are necessary to ensure the most
effective treatment
93
Sanders-Shamis M., Bramlage L.R., Weisbrode S.E., and Gabel A.A. (1989) A
preliminary investigation of the effect of selected electromagnetic field devices
on healing of cannon bone osteotomies in horses. Equine Vet. J. 21, 201-205.
Abstract: The effect of electrical stimulation by means of selected
electromagnetic field devices on healing of cannon bone osteotomies in
horses was examined. The defects were created as 3 cm x 1 mm longitudinal
osteotomies through the dorsal cortices of the mid- metacarpi/metatarsi of
adult horses. This type of defect would asses bone healing in a situation
similar to an acute, stable fracture of the cortex. Three electromagnetic
devices of different design were tested in three different groups of horses.
Healing was evaluated radiographically and histologically. Results showed
that osteotomies treated with the electromagnetic devices healed similarly to
untreated controls. Our conclusion is that the electromagnetic devices studied
did not have a local effect on the repair process of an acute, stable, osseous
defect
Sanderson K., Nyberg F., and Khalil Z. (1998) Modulation of peripheral
inflammation by locally administered hemorphin- 7. Inflamm. Res. 47, 49-55.
Abstract: OBJECTIVE: Sensory nerves mediate peripheral inflammation via
the release of sensory peptides at the site of tissue injury. Using a blister
model of inflammation, we have previously documented that endogenous
opioids modulate chronic but not acute inflammation. Hemorphins are
nonclassical opioid peptides found in the region of the beta-chain of
hemoglobin (Hb). The heptapeptide hemorphin-7 is identical with residues 35-
41 of the beta-chain of the human Hb. The aim of this study was to examine
the effect of hemorphin-7 on the inflammatory response in acute and chronic
injury models. METHODS: We have used a vacuum-induced blister model in
the footpad of anaesthetized rats to induce an inflammatory response in naive
skin by (a) electrical stimulation (ES) of the distal end of the cut sciatic nerve
at 20 V, 5 Hz, 2 ms for 1 min or (b) superfusion of sensory peptides;
substance P (SP) or calcitonin gene related peptide (CGRP) over the blister
base. In addition, we examined the effect of hemorphin- 7 on the
inflammatory response to
SP induced in a previously injured but healed skin site (recurrent injury model)
and in denervated skin site due to chronic nerve lesion (chronic injury model).
RESULTS: The results showed that prior and concomitant perfusion of
hemorphin-7 over the blister base inhibited the acute inflammatory response
to ES of the sciatic nerve at C-fibre strength in a dose-dependent manner.
Significant inhibition was achieved at 20 and 200 microM concentration of
hemorphin-7. When hemorphin-7 (20 microM) was perfused prior to and
together with SP or CGRP (both at 1 microM), over the base of acutely
induced blister in naive skin, it significantly reduced the inflammatory
response to SP (both plasma extravasation and vasodilatation), but was
without effect on the vasodilatation response to CGRP. Naloxone, the general
opioid antagonist at (1 mg/kg i.v.) reversed the inhibitory effect of hemorphin-
94
7 on the inflammatory response to SP. On the other hand, hemorphin-7 had
no effect on the inflammatory response to SP in the recurrent injury or the
chronic injury models. CONCLUSIONS: The results of this study suggest that
hemorphins might play a role in inhibiting the inflammatory response in acute,
but not in recurrent or chronic injury conditions. Evidence is also provided that
the modulatory inhibitory effect of hemorphin-7 is mediated via activation of
opioid receptor(s). The significance of this study in conjunction with our
previous work, is that it raises the possibility that different endogenous
inhibitory mechanisms may operate under different injury conditi
Schubert T., Kleditzsch J., and Wolf E. (1986) [Results of fluorescence
microscopy studies of bone healing by direct stimulation with bipolar impulse
currents and with the interference current procedure in the animal
experiment]. Z. Orthop. Ihre Grenzgeb. 124, 6-12. Abstract: 42 cross-breed
rabbit bastards of either sex were osteotomized on the left proximal third of
the tibia. A teflonisolated stable plating was made by means of the
polychromatically KF-AO-instrumentarium. The animals were
fluorescentlabelled in weekly intervals. Tetraverinex, alizarin complexon,
fluorexon, xylenol orange and calceine were used as colours. The animals
were stimulated in the bipolar squaretopped pulse current procedure (1 Hz
and 10 Hz, resp., +/- 25 and +/- 50 microA, resp., intensity, permanent
stimulation) or in the interference current procedure (oscillation frequency 100
Hz, intensity 1 mA, 4 hours daily). An osteotomized group served as a control.
The undecalcified bone sections were quantitatively measured in the area of
the periosteal and endoosteal accummulation seams as well as in the area of
the Haversians canals and compared by means of multiple variance
analyses. A delay in the Haversian remodelling within the first 2 weeks was
found in the animals only osteotomized. This delay could not be detected in
all electrically stimulated groups. The electrical stimulation leads to a
shortening of the fracture healing period by skipping the physiologically
occurring delay of the Haversian remodelling in fractures and osteotomies.
Further on there was derived a growth function of the osteones as a
regression function r (t) = a + beta X e gamma t. For the rabbit the concrete
formula expression r (t) = 50.9 X e-0.094 X t + 17.4 for the animals not treated
and r (t) = 42.9 X e-0.067 X t + 8.5 for the electrical stimulated animals has
been found.(ABSTRACT TRUNCATED AT 250 WORDS)
Shandler H.S., Weinstein S., and Nathan L.E., Jr. (1979) Facilitated healing of
osseous lesions in the canine mandible after electrical stimulation. J. Oral
Surg. 37, 787-792. Abstract: A study was performed to investigate the effect
of electrical stimulation on the repair of osseous lesions in the canine
mandible. Results showed considerably more osteoblastic activity on the
electrically stimulated side, with maximal growth
nearest the negative electrode. Histologic examination showed healing consisted
of the production of intramembranous bone, with no evidence of neoplastic
95
changes. The practical uses of electrical stimulation in the practice of oral and
maxillofacial surgery are discussed
Sharp I.K. and Lightwood R. (1983) Stimulation of bone union by externally
applied radio-frequency energy. Injury 14, 523-530. Abstract: Pulsed radio-
frequency electrical energy has been used for many years in the treatment of
various soft tissue lesions, and this paper describes its use in stimulating
repair in delayed and non-union, with a success rate in 16 cases equal to that
of the other electrical stimulation techniques. The equipment is described and
a theory proposed that the cell membrane has a diode effect in allowing the
absorption of electrical charge, which, by its influence on the calcium ion,
stimulates the cell into activity
Simonis R.B., Shirali H.R., and Mayou B. (1991) Free vascularised fibular grafts
for congenital pseudarthrosis of the tibia. J. Bone Joint Surg. Br. 73, 211-215.
Abstract: We describe 11 patients with congenital pseudarthrosis of the tibia
treated by a free vascularised fibular graft (FVFG) and followed up from 10 to
64 months (mean 38). Bony union was achieved in nine of the 11 cases: two
failures required amputation. The mean time for union in the successful cases
was five months. Nine of the 11 patients had had an average of four surgical
procedures before the FVFG, so the graft was a salvage procedure for which
the only alternative was amputation. FVFG is recommended as a primary
procedure for the treatment of congenital pseudarthrosis of the tibia if there is
a large tibial defect (over 3 cm) or shortening of more than 5 cm. The primary
use of this operation is not advised for cases in which standard orthopaedic
procedures are expected to succeed. For a small defect with a favourable
prognosis (Boyd and Sage 1958), we recommend conventional bone grafting,
intramedullary nailing and electrical stimulation
Smith J., Romansky N., Vomero J., and Davis R.H. (1984) The effect of electrical
stimulation on wound healing in diabetic mice. J. Am. Podiatry. Assoc. 74, 71-
75.
Spadaro J.A. (1977) Electrically stimulated bone growth in animals and man.
Review of the literature. Clin. Orthop. 325-332. Abstract: The literature on the
electrical stimulation of bone growth and fracture healing has been increasing
exponentially in recent years. About 95 per cent are positive reports despite
an extraordinarily wide selection of experimental techniques and models.
Fourteen research groups report that electrical currents stimulated fracture
healing with few if any complications in a total of 595 patients. The
mechanisms of action and ideal technique for applying stimulation has yet to
be determined
Spielholz N.I. and Kloth L.C. (2000) Electrical stimulation and pulsed
electromagnetic energy: differences in opinion. Ostomy. Wound. Manage. 46,
8, 10, 12.
96
Srivastava K.P. and Saxena A.K. (1977) Electrical stimulation in delayed union of
long bones. Acta Orthop. Scand. 48, 561-565. Abstract: The role of electricity
in the promotion of fracture union of long bones in human beings requires
further investigation. An electric stimulator was devised through which 15
microamperemeter current was applied to the fractured long bones
of 20 patients with delayed union. The best results were obtained in cases where
the negative electrode was introduced at the fracture site and the positive
electrode was placed proximal to the fracture area. In 90 per cent of cases
treated by different methods in this series, union occurred within an average
period of 9 1/4 weeks. The rate of infection following introduction of
electrodes for electrical stimulation was 20 per cent
Srivastava K.P. and Saxena A.K. (1977) Fracture healing in a case of nonunion
of the tibia by electrical stimulation. Int. Surg. 62, 35-36.
Srivastava K.P., Lahiri V., Khare A., and Chandra H. (1982) Histomorphologic
evidence of fracture healing after direct electrical stimulation in dogs. J.
Trauma 22, 785-786. Abstract: A histomorphologic study was done at
intervals up to 10 days after causing a fracture in both hindleg tibiae in dogs
and giving direct electrical stimulation in one tibia, the other being used as
control (20 microns ampere of direct current were passed in 28 limbs and the
current was maintained with the help of a simple regulator developed by the
authors). The radiologic and histomorphologic study showed definite evidence
of early start and completion of healing processes in the electrically
stimulated hindlegs. Negative potentials induced at the fracture sites
appeared to be the cause of improved healing. The incidence of infection and
focal necrosis at the anode was minimal in this experiment
Steckel R.R., Page E.H., Geddes L.A., and Van Vleet J.F. (1984) Electrical
stimulation on skin wound healing in the horse: preliminary studies. Am. J.
Vet. Res. 45, 800-803. Abstract: The effect of low-level direct-current
stimulation on skin wound healing in the horse was assessed. Self-sustaining
electrical circuits with electrodes were implanted subcutaneously in or near
the wound. Stimulation by direct current (10 or 20 microA) was used to
determine the effect on equine skin healing. The efficacy of electrotherapy
was evaluated by sequentially comparing the clinical appearance of the
wound and measuring the size of the granulating wound bed. The histologic
appearance of the healing stimulated wounds was compared with that in
nonstimulated control wounds created on 9 horses. Seemingly, electrical
stimulation had no discernible effect on experimentally created skin wounds.
Clinical observation and histologic examination of the wounds indicated that
severe tissue reaction from the implanted electrodes and concurrent local
infection produced local detrimental effects to wound healing
97
Steiner M. and Ramp W.K. (1990) Electrical stimulation of bone and its
implications for endosseous dental implantation. J. Oral Implantol. 16, 20-27.
Abstract: Applied electrical potentials can alter cellular movement, stimulate
production or destruction of cells, and change the chemical concentration and
composition of both soft tissue and bone. These actions vary depending on
the microamperage and duration of the applied current and whether it is
continuous or pulsed, the type of metallic electrode, and the types of cells or
tissues involved. Relative to skeletal effects, researchers have accumulated
data from bone cell cultures, embryonic and adult animal bone, and human
clinical studies. This article reviews the historical use of electric current for
fracture healing, the piezoelectric effect found in tissues, and the possible
deleterious effects of electrical stimulation. The types of electric current
presently used for treating extremity fractures and reports where electric
current has been used on tissues in the oral cavity are
discussed. Alternate sources of energy to stimulate bone and possible
implications for use of electrical stimulation to augment attachment of
endosseous dental implants are also included
Stewart K.M. (1991) Review and comparison of current trends in the
postoperative management of tendon repair. Hand Clin. 7, 447-460. Abstract:
The precision of the Evans/Burkhalter protocol and the work by Silverman
and associates exemplify one of the most valuable of all current trends in
rehabilitation of the healing tendon. Knowledge of tendon excursion at each
level and throughout the range of motion in each joint gives us safe
parameters for tendon mobilization. Hand rehabilitation is becoming more of a
science while remaining an art. Research into tendon healing, nutrition,
anatomy, biomechanics, and physiology gives us a solid basis for our
treatment techniques. We now need to replicate studies already performed
and quantify more precisely the data we have. Many questions remain
unanswered. There is a wide variety in the position of splinting for flexor
tendon mobilization under current protocols: What joint positions are optimal
and why? The number and frequency of repetitions in early mobilization
protocols varies greatly: What number and frequency is more appropriate for
which patients? How much tendon excursion will control adhesions, promote
healing, and avoid gap formation or elongation of the repair? How much force
should we apply passively to maintain or increase joint motion? How soon
should we start active motion, and how can we control the strength of those
early muscle contractions? Do "place-hold" exercises truly place less tension
on the repair site? How soon should we begin resisted exercise, and how
much resistance are we applying with each type of exercise? Should blocking
exercises be considered resistive? How should tendon management
protocols be adapted in the presence of associated injuries? Lack of space
has prevented discussion here of recent and needed research in a number of
areas, such as the effectiveness and appropriate precautions for the use of
ultrasound, iontophoresis, and neuromuscular electrical stimulation in tendon
98
management. The evidence is growing, but we have a long way to go. To
improve our clinical results, the trend toward precision must continue and
grow
Sumano H. and Mateos G. (1999) The use of acupuncture-like electrical
stimulation for wound healing of lesions unresponsive to conventional
treatment. Am. J. Acupunct. 27, 5-14. Abstract: Based on previous
experimental evidence suggesting improved healing of wounds treated with
electrical stimulation, we conducted a clinical trial with patients seeking
alternative medicine after unsuccessful conventional medical treatment.
Electricity was delivered in two forms: (1) For wounds with extensive loss of
tissue and/or those that had failed to heal spontaneously, electrical
stimulation was delivered via subcutaneously inserted needles surrounding
the wound edges and applying a dose charge of 0.6 coulombs/cm2/day; (2) in
second degree burn injuries, lesions were covered with gauze soaked in a
10% (w/v) sterile saline solution and the same dose of electricity was applied
as for (1). Forty-four patients were treated with electrical stimulation of the
skin; 34 in group (1) and 10 in group (2). Following electrostimulation in all
patients in both groups healing proceeded in a thoroughly organized manner,
almost regardless of the severity of the type of wound or burn treated.
Advantages and limitations of this technique are discussed
Taskan I., Ozyazgan I., Tercan M., Kardas H.Y., Balkanli S., Saraymen R., Zorlu
U., and Ozugul Y. (1997) A comparative study of the effect of ultrasound and
electrostimulation on wound healing in rats. Plast. Reconstr. Surg. 100, 966-972.
Abstract: A comparative study has been carried out to investigate the effects
of electrical stimulation and ultrasound on wound healing. Eighty-four female
rats were divided into four groups depending on the treatment received. The
first group was given electrical stimulation of 300 microA direct current, 30
minutes daily, starting with negative polarity and then changed after 3 days of
treatment. Group 2 received sham electrostimulation treatment. The third
group received 0.1 W/cm2 pulsed ultrasound using the moving applicator
technique for 5 minutes a day. Group 4 received sham ultrasound treatment.
A total of 7 days of treatment was given to all groups. Histopathologic and
biochemical analyses on the fourth and seventh days and wound breaking
strength on the twenty-fifth day were performed for all groups. By accelerating
the inflammatory phase, electrical stimulation had progressed the proliferative
phase of wound healing earlier than ultrasound had done. Both electrical
stimulation and ultrasound have positive effects on proliferative phases, but
electrical stimulation was superior to ultrasound at the maturation phase.
There was no difference between the two experimental groups on the mast
cell reduction effect. Although ultrasound treatment may seem to be efficient
in terms of time, when the effects of electrical stimulation and ultrasound on
wound healing with the methods employed in our study are considered, it is
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concluded that electrical stimulation is a means of treatment superior to
ultrasound in wound healing
Uhl R.L. (1989) The use of electricity in bone healing. Orthop. Rev. 18, 1045-
1050. Abstract: The history of electrical bone healing and the vast amount of
laboratory and clinical data that support its efficacy are reviewed. The paper
presents guidelines for the proper use of electrical stimulation and a
description of the various systems available. The use of electrical stimulation
to treat scaphoid fractures is covered in detail. Contraindications to the use of
electrical stimulation are also addressed
Unger P.G. (1992) Wound healing currents: a brief review of recent research
points to electrical stimulation as a viable treatment technique. Rehab.
Manag. 5, 42-43.
Valdes A.M., Angderson C., and Giner J.J. (1999) A multidisciplinary, therapy-
based, team approach for efficient and effective wound healing: a
retrospective study. Ostomy. Wound. Manage. 45, 30-36. Abstract: This
paper presents a 4-year retrospective study (1994 to 1998) of therapy-based
treatment outcomes for chronic wounds of all stages and most common
etiologies. Treatment in this study consists of outpatient wound treatments
given by trained therapists and nurses who were supervised by the podiatrist
or internist. Many patients were referred to the clinic for last-resort treatment
(i.e., electrical stimulation, topical hyperbaric therapy, etc.) before major lower
extremity amputations: hip disarticulation, above knee amputation (AKA),
below- knee amputation (BKA). This study does not consider age, sex,
chronicity, or ethnicity because the authors want to demonstrate the
effectiveness of this treatment approach for healing chronic wounds
notwithstanding these variables. Wound healing was achieved in 100% of
patients who completed their treatment program (233 patients with 242
wounds). This study shows the total average healing time for wounds is 7
weeks for Stage II wounds, 10 weeks for Stage III wounds, and 19 weeks for
Stage IV wounds. The average healing time for diabetic wounds is 14 weeks
(wounds of neuropathic origin heal in 12 weeks and wounds of ischemic
origin heal in 16 weeks). The average healing time for venous stasis wounds
is 8 weeks. The study includes patients with ischemia who are not candidates
for
revascularization. The authors assert that the most effective treatment for wound
healing is a therapy- based, multidisciplinary team approach. This
retrospective study shows that the goal of complete healing is attainable
Waldorf H. and Fewkes J. (1995) Wound healing. Adv. Dermatol. 10, 77-96.
Abstract: Wound healing is a dynamic biologic process of repairing insults to
the integumentary system. It is commonly divided into three phases:
inflammatory, proliferative, and maturation. Each phase has unique cellular
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and substance constituents without which it cannot progress normally. A large
variety of factors may influence any part of wound healing, including local
factors such as bacteria, oxygen tension, and bleeding, and systemic factors
such as the mental and physical health of the patient. There are also extrinsic
factors that can be influenced by the caretakers of the wound to enhance
wound healing. Areas of intervention include using antiseptic technique when
one is dealing with the wound, using good surgical technique, choosing the
appropriate wounding method and repair for the individual patient, and using
antibiotics and special wound dressings. Modern science and technology are
giving us new insights into wound healing and leading us to exciting new
ways of influencing it, including the topical use of growth factors, artificial
skins, cultured epithelium with and without dermal components, and electrical
stimulation. The future of wound healing holds a better understanding of the
complexities of the physiologic events that occur and a translation of that into
a biologically active and interactive wound care
Walter T.H. (1985) Bioelectrical osteogenesis: acceleration of fracture repair and
bone growth. An alternative to bone grafting in nonunions. Clin. Podiatry. 2,
41-57. Abstract: Electrical stimulation of fracture nonunions has become a
viable alternative to bone grafting. The success rate is comparable but the
morbidity rate is significantly lower. Individual fracture healing problems must
be thoroughly assessed and the treatment designed for the individual patient
Weiss D.S., Kirsner R., and Eaglstein W.H. (1990) Electrical stimulation and
wound healing. Arch. Dermatol. 126, 222-225. Abstract: Living tissues
possess direct current surface electropotentials that regulate, at least in part,
the healing process. Following tissue damage, a current of injury is generated
that is thought to trigger biological repair. In addition, exogenous electrical
stimuli have been shown to enhance the healing of wounds in both human
subjects and animal models. Intractable ulcers have demonstrated
accelerated healing and skin wounds have resurfaced faster and with better
tensile properties following exposure to electrical currents. This article
examines the bioelectric properties of living systems and reviews the existing
literature on electrical stimulation and wound healing
Westerman R.A., Carr R.W., Delaney C.A., Morris M.J., and Roberts R.G. (1993)
The role of skin nociceptive afferent nerves in blister healing. Clin. Exp.
Neurol. 30, 39-60. Abstract: Because sensory neuropeptides improve survival
of critical skin and muscle flaps in rats, skin nociceptive sensory nerve
function in blister healing was examined. Sensory nerve ablation by unilateral
hindlimb denervation or cutaneous axon reflex enhancement by 14 days
systemic nicotine treatment (5 mg kg-1 day-1) decreased and increased,
respectively, peripheral motor functions of nociceptive (peptidergic) skin
nerves. Effects on nociception were measured by a radiant heat
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tail-flick test. Axon reflex flares were evoked by transdermal iontophoresis of
acetylcholine or noxious electrical stimulation under pentobarbitone 40 mg kg-
1 anaesthesia. Resultant changes in cutaneous microvascular blood flux were
measured non-invasively by laser Doppler flowmetry. In nicotine-treated rats
compared with placebo-treated controls, acetylcholine-evoked axon reflex
flare was enhanced by 240% (p < 0.01) without enhancement of electrically
evoked flare. Thus, nicotine-sensitized nociceptors show stimulus specificity
in their enhancement of neurogenic flare responses. No significant changes
were seen in other endothelial-dependent or smooth muscle-dependent
microvascular dilator responses. Nicotine-treated rats had prolonged tail-flick
withdrawal latencies to noxious radiant heat stimuli compared with placebo-
treated controls (p < 0.05), suggesting an antinociceptive or analgesic effect
of nicotine-treatment. Neurogenic effects on wound healing rate were
assessed by measuring the dimensions of standardized blisters twice daily.
The blisters were raised on hindpaw glabrous skin using a constant weight
and diameter of compressed dry ice pellet applied for 30 secs at constant
force. Dry- ice blisters raised on the hindpaw 14 days post-denervation were
significantly slower to heal completely (42 days) than controls (30 days: P <
0.05) and the surrounding inflammation was reduced. By contrast, nicotine-
treated rats showed more rapid blister healing (25 days) than controls (30
days), seen only in the later phase after day 15. Finally, resting substance P
release from blisters, after direct cutaneous nerve stimulation, appears to be
enhanced in nicotine-treated rats. Thus nociceptive innervation appears
critical for inflammation and rapid healing of blisters in rat skin. The data
signal a possible important role for neuropeptides in these processes and
question the function of nicotinic receptors on sensory nerves