Note: Descriptions are shown in the official language in which they were submitted.
CA 02363383 2001-11-13
PHOTODYNAMIC STIMULATION DEVICE AND METHODS
BACKGROUND OF THE INVENTION
Field of the Invention
The present invention relates in general to electrotherapy devices and more
particularly to devices
and methods for photodynamic stimulation of living tissue, directly and also
indirectly by
stimulation of photosensitive substances introduced into or onto living
tissue.
Description of the Related Art
Mitochondria within cells of protozoa and metazoa represent sources of energy
delivering
vesicular respiration. They are moreover capable of synthesizing proteins,
because they dispose
from the cell nucleus an independent or self dependent genetic system ofDNA
and RNA.
The mitochondria's main function however is vesicular respiration, that is
within the cells the
tn~.nsformation of nutrient media and oxygen either supplied through the blood
stream or in some
other way into energy and endogenous substances, whereby through this
transformation, waste
products like water, carbon dioxide, alcohol and lactic acid are produced. Of
great importance is
adenosine-triphosphorus acid (ATP), which is synthesized by the mitochondria
into adenosine-
diphosphorus acid (ADP) and orthophosphate. Complicated 20 chemical compounds
are of great
importance as reaction catalyst.
Stimulation of the vesicular respiration, especially a stimulation of the ATP
production by cells,
is used therapeutically, preferably for the promotion of strong use of cell
energy in the healing
processes and by reduction of weight, healing of wounds and a reduction of
pain sensitivity due
to an illness or weakness caused by hypopolarization or depolarization of the
cell membrane. In
general, weakening of cells caused by an increase of vesicular respiration due
to stress, illness or
by old age can be counteracted. In order to achieve stimulation of the
mitochondria through
optical radiation, two conditions must be fulfilled. The radiation must be of
appropriate
wavelengths in order to be elective, and a pulse frequency must be chosen to
penetrate to an
appropriate tissue depth without causing tissue damage or pain.
CA 02363383 2001-11-13
A device is known (Patent DE-U-8-13852lNormed, E. Larsen). which uses infrared
radiation for
the photodynamic stimulation of energy in living cells, cells at the surface
of the skin and
especially cells lying deeper down. The device consists of a supply and
control mechanism and
an applicator on which infi~red radiation fibm 900 nm (1 nm = 1 nanometer)
radiating IR
(infi~ared) semiconductor diodes are mounted with reflectors for the bundling
of the IR radiation
fi~om the applicator. In this known device, a generator containing a
controller mechanism supplies
the semiconductor diodes with current pulses of a certain frequency within the
range of 500
5000 Hz. A disadvantage of the known device is that the semiconductor diodes
during use tend to
overheat, which causes a decrease in the effectiveness of the device.
The known device therefore does not deliver a constant effect during use.
Another disadvantage
is that only infrared radiation within a range of 900 nm is available, while
other wavelengths may
be called for to achieve cell stimulation.
Light is used for bonding and hardening of plastic composite filling materials
containing an agent
which is photosensitive to light of 400 - 500 nm wavelength (blue light).
Worldwide, there are many producers of such materials (e.g., 3M Corporation,
which also
manufactures appropriate lamps). Information on these materials and lamps may
be found on the
Internet.
Well known in the art is a halogen lamp with a lamp housing including a
reflector and a filter to
obtain light output in the 400 - 500 nm range (blue light). The housing also
contains a fan to cool
the lamp and filter but practical considerations concerning the size of the
housing and the
capacity of the fan typically result in insuihcient cooling during operation,
which causes the
light output to vary. This can result in improper hardening, and perhaps also
shrinking, of the
fillings. Further, the lamps and filters must be replaced fi~equently. And,
the apparatus is bulky
and thus unwieldy in use.
The halogen apparatus has in the past been used mainly for setting plastic
fillings in front teeth
where relatively small amounts of filling material, are used, and access is
relatively easy.
Recently however, there has been speculation that so-called silver fillings
(actually mercury
2
CA 02363383 2001-11-13
based) which have traditionally been used in the larger teeth may pose health
risks, and many
patients are requesting plastic fillings instead. Fillings in the larger teeth
require much more
filling material, and thus much more light dosage in order to harden properly
without shrinkage,
than in front teeth. The di~culties of using the unwieldy halogen apparatus
are thereby exacer-
bated. For example, operating them at higher output results in temperature
fluctuation,
which in turn results in fluctuation of the light intensity which may result
in improper hardening,
and perhaps even shrinkage, ofthe fillings. Also, the lamps will have to be
replaced more often.
In the field of dermatology, light is used as a stand-alone therapy for
wounds, leg 20 ulcers,
eczema, burns, etc., and as such is used to stimulate tissue directly.
Techniques are known for
introducing agents for altering the light absorbing qualities of tissue to
enhance the effect of light
(for example, U.S. Patent 5,226,907 to Tankovich teaches contamination of hair
follicles with a
dark particulate material to enhance light-induced heating in the follicles
for hair removal).
Treatments have included the application of substances such as photofi-in, 5-
aminolevulan acid,
hematoporphyrin, verteporfin, chlorins, phthalodyanines, phenothiazine, and
benzoporphyrin-
derivative monoacid-A (ATMPn) onto or into tissue for healing solar keratoses,
basal cell
carcinoma, melanomas, etc. Such substances are known as "biopharmaceuticals"
and treatment
with these substances has been called biopharmaceutical therapy. Therapy
involving the
application of biopharmaceuticals and their subsequent activation by light
after they have been
absorbed into tissue has been called photodynamic therapy (PDT).
PDT has been used successfi~lly in the treatment of internal inoperable
cancers. A
biopharmaceutical (specifically, hematoporphyrin) is injected into the
tumortissue, and an optical
method known as photodynamic diagnostic (PD) is used to determine when the
biopharmaceutical has been absorbed by the entire tumor. Then the tumor tissue
is irradiated with
light typical for a dye laser, which activates the photosensitive reactors in
the hematoporphyrin,
whereby singlet oxygen is liberated. Singlet oxygen is toxic to protein and
phosphorlipids in the
tumor tissue, whereby the tumor is destroyed without destroying the
surrounding tissue.
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CA 02363383 2001-11-13
For treatment of skin keratosis (pre-cancerous tissue), trials with, for
example, 5- aminolevulinic
acid have shown that it can be used effectively in PDT if introduced into oil
in a water suspension
which is then applied to skin keratosis and then irradiated with a light
source. A fast and
cosmetically perfect healing has been attained with a very low rate of
recurrence compared to
conventional treatments, such as cryotherapy. In view of these favourable test
results, it is
anticipated that pharmaceutical companies will be marketing the next
generations of PDT
chemicals in convenient forms, such as creams, suspensions, sprays, etc.
The light source typically used to irradiate PDT chemicals is commonly known
as the surgical
laser, a solid-state laser which is bulky, and which is expensive both to
purchase and to operate.
Surgical lasers are designed primarily for cutting, i.e., they output very
high energy in a very
small spot, and are thus difficult to adapt to the requirement to irradiate a
more generalized area
for PDT. Further, they generally radiate at a single wavelength. Radiation at
several wavelengths
is desirable in PDT, for several reasons: a single wavelength may cause the
patient to experience
burning pain in the tissue adjoining the tissue under treatment; some
photosensitive chemicals
respond to two different wavelengths; and, some pigmented melanomas do not
respond to visible
radiation due to absorption in the pigment (typically melanin), and must be
irradiated with near-
infrared light.
Common dermatological diseases like acne, warts, and onycho-mycosis (nail
fungus) can
successfully be treated with light as a stand-alone treatment, but recent work
indicates that
treatments using PDT (with ALA/5-aminolevulanic acid) give excellent results
with only two or
three treatments.
In a recent pilot study using PDT to treat acne, the cosmetic results were
excellent, and oil gland
activity which causes acne, and the resultant inflammation, were reduced for
as much as twenty
weeks after a series of PDT treatments. (The PDT treatments precipitated
immediate but short-
term inflammatory reactions.) In general the photodynamic stimulation used in
the physiotherapy
is producing very good results, but in the area of long-term chronic diseases
such as gout,
arthritis, etc. there is often a need for many treatments, as many as 12 -20
treatments spaced over
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CA 02363383 2001-11-13
a period of time. Also, initial phases of such treatment often cause
reactions, which in turn cause
pain and discomfort.
SUMMARY OF THE INVENTION
The present invention provides a device using red and infrared radiation of
several wavelength
ranges suited for the photodynamic stimulation of the cell energy in living
cells, in particular
human cells ofboth surface and underlying tissue. Furthermore, blue light is
provided as well to
enhance vesicular respiration, particularly stimulation of the ATP production
in cells, thus
enhancing the therapeutic capabilities of the device.
The device consists of a standpillar, with which machine applicators are
connected through a
jointed arm. The standpillar, freely moveable on wheels, consists ofcontrol
mechanism, whereby
the desired therapy data can be adjusted and the device can be switched ON and
OFF. The
plain surface applicators can consist of more applicators placed side by side,
connected and
moveable with each other through hinges, whereby the applicators are suitable
for the treatment
of large-area tissues, for example, the human back.
The applicators contain printed circuit boards mounted with semiconductor
diodes and/or laser
diodes (in large numbers) and the diodes are mounted with reflectors, which
collect the radiation
and bundle them in front of the applicator. At least one of the applicator
elements is equipped
with sensors for controlling if the amount of radiation is suitable for the
patient. The applicator
contains a polarization filter, which is placed directly in front of the
diodes. The control
mechanism is also connected with a hand applicator, which is constructed for
treatment of small
tissue areas, e.g., acupuncture points and trigger points (pain points).
The hand applicator includes a cylindrical shaft, to which a headpiece is
connected. At the
head piece a printed circuit board is fastened mounted with semiconductor
diodes or laser diodes.
The light radiation emits finm a cleft in the head piece, which also has a
light radiation opening
in the front. In the head piece, in finnt of the opening, a lens for the
focusing of the light rays and
a polarization filter is placed. A second version hand applicator, which is
especially invented for
CA 02363383 2001-11-13
dental treatment shows at the front end of the shaft a printed circuit board,
where an IR (infrared)
light semiconductor diode or laser diode and a blue light semiconductor diode
are placed. The
head piece in finnt of the printed circuit board can be rotated 180° so
that the expander, which
contains an optical fibre, can be positioned in front of either the one or the
other radiation
source.
The invention provides multiple wavelength stimulation that is effective in
conjunction with
photodynamic therapy (PDT) chemicals. Such chemicals are applied or injected
into or onto
tissue to be treated, and subsequent photo-stimulation ofthem causes reactions
in them that result
in treating the tissue. Irradiation at multiple wavelengths enhances the
effects of PDT chemicals
while reducing discomfort to the patient.
The present invention provides an apparatus including a semiconductor light
source including a
hand applicator. The hand applicator can selectively emit light of various
wavelengths and
introduce the light-sensitive substances into the tissue by means of air-
pressure and electrical
impulses (Ionto-phoresis). The absorption time, depending on the type of light-
reactive
substances, may vary from 1 to 24 hours without this technique. Other
advantages with the
described technique are that the light-sensitive substances can be applied
very precisely and the
absorption dose can be improved and more accurately regulated.
The present invention provides an apparatus including a semiconductor light
source, and further
includes a hand applicator. The applicator may selectively emit blue light for
the bonding and
hardening of composite plastic fillings or infrared light for treatment of
dental pain, gingivitis,
and wounds. In order to optimize bonding by the blue light, output of the hand
applicator is
supplied at 25 % of fill power for the first ten seconds of the radiation
time, and then is switched
to full power.
Other advantages of the invention will become evident from the following
description of the
invention and from the appended drawings, wherein:
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CA 02363383 2001-11-13
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a drawing of the inventive device in perspective description;
Figs. 1 a, l b, 1 c illustrate details from the machine applicator of the
inventive device;
Fig. 3 illustrates a jointed arm used for the movable connection ofthe machine
applicators;
Fig. 4 is a circuit block diagram of a controller unit, which supplies the
applicators.
Fig. 5 depicts a hand applicator according to the present invention;
Fig. 6 depicts an applicator conforming to Fig. 5 with axial light emission;
Fig. 7 depicts an applicator conforming to Fig. S with radial light emission;
Fig. 8 an applicator with a rotary headpiece;
Fig 9. shows details of a printed circuit board for the applicator of Fig. 8;
and
Fig. 10 depicts the molecular structure of ammi visnaga, a herbal substance
for use with the
presentinvention.
Fig. 11 shows the air unit with the hand applicator belonging to this part of
the invention device.
Fig. 12 illustrates an exchangeable round head for the hand applicator.
7
CA 02363383 2001-11-13
Fig. 13a shows the hand applicator for light-sensitive substances in a bottom
view.
Fig. 13b illustrates the hand applicator in a side view.
DETAILED DESCRIPTION OF TI3E PREFERRED EMBODIMENT
As shown in Fig. 1, the inventive device 10 for the energy stimulation of
cells consists of a
standpillar 11, with which machine applicators 13 (in the following just
called applicators 13) are
connected through a jointed arm 12. The standpillar 11 is also connected by an
electric circuit
14 with hand applicator 15. The standpillar 11, freely movable on wheels,
includes control
mechanism 16 (described in Fig. 4). whereby the fimction of the control
mechanism 16 can be
adjusted and switched ON/OFF at a control board 30 (also called description
equipment 30).
The Fig. 2a, 2b and 2c show plain surfaced applicators 13. which can be used
in the working
model according to Fig. 2a to 2c individually, side by side (in large numbers)
or in combination
with an applicator. According to Fig. 2 a, the applicators 13 in the working
model are mounted in
a shifting order with semiconductor diodes 17 and 17a (in the following called
diodes), whereby
shifting the order of diodes 17 means, that the respective diode 17a of one
row is placed at the
point of intersection of the two diagonals through the two respective diodes
17, which are placed
adjoining on both sides. The diodes 17 and 17a are mounted with reflectors 18,
which collect the
radiation and bundle it in front of the applicator 13. The applicator contains
a polarization filter,
which is placed directly in finnt of the semiconductor diodes 17 and 17a,
whereby the radiation
can be better absorbed by the irradiated tissue.
According to Fig. 2b and 2c the diodes 17 are placed in regular row
arrangements, i.e., 20
equidistant from each other, whereby, according to Fig. 2c, one applicator 13
additional to the
diodes 17 has a light source 19. The diodes 17 radiate light in three
wavelengths which are 600,
900 and 1200 nm, i.e., red and infrared (IR) radiation. The light source 19
formed as a cylinder as
well as the diodes 17a (Fig. 2a) radiate light with a wavelength of 350 - 500
nm, i.e., blue light.
8
CA 02363383 2001-11-13
For the treatment of large-area tissues according to Fig. 1, more applicators
13 are connected and
movable with respect to each other through hinges 10, respectively connecting
one edge with the
other, whereby the applicators are suitable for the treatment of, for example,
the backs of humans
and so become adjustable for an equidistant positioning of the applicators 13.
The joint arm 12,
shown at Fig. 3, connects one or more applicators) 13 with the standpillar 11.
The jointed arm 12
has three joint Garners. 21, 22, 23, where the joint carrier 21, together with
the standpillar 11 and
the joint carrier 23 are moveable at a free end through a fixing joint 24
connected with one or
more applicators 13. Another fixing joint 25 connects the joint carrier 23
with 21, while the joint
carrier 22 is connected with the joint carrier 21 with a hinge 26. The joint
carrier 21 is connected
with the standpillar 11 through a joint 27. The jointed arm 12 thereby allows
the positioning of
the applicators 13 in front of, or above, a tissue area while maintaining a
correct positioning
distance. The jointed arm 12 also carries the electrical circuits 14 (not
further described) from the
control mechanism 16, which is integrated in standpillar 11, to the
applicators) 13.
According to Fig. 4 the controller mechanism 16 consists of a generator 28, a
timer 29, and a
display 30. With help of the generator 28 the current impulses necessary to
the production of light
are contributed, while over timer 29, all time functions are adjustable, e.g.
the duration of
treatment. Display 30 shows pertinent treatment data, as current pulse
frequency, pulse length
and pulse amplitude. With help of the controller mechanism 16 the inventive
device with
reference to duration, amplitude and frequency of surge of current is
adjustable within a relatively
large range, so that the diodes 17, 17a and 19, as well as laser 17 diodes
with the same realization
as diode 17, can be used as light sources. For that purpose the controller
mechanism is equipped
with a changeover switch for operating either with semiconductor diodes 17 or
with laser diodes.
For the semiconductor diode mode, operating diodes 17 and at the same time the
diodes 17a or
19 for blue light are supplied with current pulse frequencies from 200 to
20,000 Hz with current
pulse lengths between 2 and 200 microseconds, preferably between 2 and 20
microseconds, and
current pulse amplitudes from 12 to 25 Volts. Operating this way overheating
is avoided because
of the short current pulse lengths. Therefore operation with a constant effect
is attained. At the
9
CA 02363383 2001-11-13
same time at each diode 17, produces simultaneous light emissions within the
three separate
wavelengths 600, 900 and 1200 nm. Through a simultaneous stimulation of the
blue light diode's
17a, and 19, there are four radiation ranges with wavelengths of 350 - 500 nm
(blue-light) as well
as 600, 900 and 1200 nm which is available for therapeutic use. Light within
the range of blue
light stimulates activities within the cells and through that the regeneration
of fatigued and sick
tissue, especially the decomposition of fatty deposits during weight reduction
therapy. The main
radiation comes from the infiared semiconductor diodes 17. Radiation within
the range of 600
nm stimulates primarily the vesicular respiration of the upper tissue, while
the radiation within
the range of 900 nm causes a stimulation of cells from the tissue surface down
to about 70 mm in
the deeper tissue. The radiation within the range of 1200 nm penetrates even
deeper into the
tissue and stimulates especially the water absorption in a living organism.
For the second operating mode, namely the laser operating mode, laser diodes
work as light
sources 17 supplied with current pulses with a frequency from 200 and 20,000
Hz, a current pulse
length between 2 and 200 nanoseconds, preferably between 2 and 20 nanoseconds,
and a current
pulse amplitude from 40 to 400 Volts. A laser radiation with a wavelength
somewhere in the
range from 400-1500 nm would have the same therapeutic effect as light ofthe
same wavelength
produced by semiconductor diodes 17, as long as the laser operating mode keeps
the current
pulse length for the photodynamic biostimulation within a range of 2 - 200
nanoseconds.
Adjustment to short pulse lengths within the range of 2 to 20 nanoseconds
combined with a high
operating potential results in a double-photon radiation of the laser diode,
which again causes a
blue light radiation within the wavelength range of 350 - 500 nm. With the
help of this two-
photon tool in the right infrared range the relatively large energy of the
blue light, which
normally is already absorbed at the skin's surface, can be transmitted much
deeper down into
the tissue. During the absorption of the double photons (2.8 e. v.)
cytochromes within the range
of blue light are made active. Moreover the double photons stimulate the
activity of the
chymotrypsin enzymes.
CA 02363383 2001-11-13
The applicators 13, according to the Fig. 2a. 2b and 2c, are equipped with
sensors 32 arranged
between the semiconductor or laser diodes 17. For therapeutic uses it is
typically intended to
apply a given amount of energy (Joule/cm2) per irradiated surface of tissue,
which can be
adjusted at the controller mechanism 16. Sensors 32 measure the amount of
energy radiated away
finm the skin surface, which is indicative of the total energy penetrating
into the tissue. Taking
into account individual variations finm patient to patient, the exposure can
be determined
according the measurements taken by sensors 32 so that the correct amount of
therapeutic energy
(Joule/cm2) reaches the tissue. An increase of the registered amount of energy
can be achieved
by the inventive device by increasing the operating potential (and thereby the
pulse amplitude) or
the pulse frequency and/or prolonging the duration of the treatment time
through an adjustment
of the controller mechanism 16.
While the applicators 13 according to Figs. 2a. 2b and 2c are constructed for
the treatment of
larger tissue areas, the hand applicator's 15a, 15b according to figs. 5 and 8
are constructed for
the treatment of small tissue areas.
The hand applicator 1 Sa includes a cylindrical shaft 34 to which a headpiece
35 is connected. At
the head piece 35 a printed circuit board 36 is fastened with light sources
mainly from
semiconductor diodes 17 (not described). At the printed circuit board 36 there
can also be placed
a blue light semiconductor diode 17a, which is stimulated in the same way as
the diodes of the
applicators 13, so that light 38 of wavelengths 400, 600, 900 and 1200
nanometers is available,
and according to Fig. 7, radiates finm a cleft 37 in the head piece 35. For
the polarization of the
light rays, a polarization filter 41 is placed in front of the printed circuit
board 36. The use of the
polarization filter brings about the advantage that the radiation can be
better absorbed by the
treated tissue. The head piece 35 also has a radiation opening in the front
39. In headpiece 35, in
front of the opening 39, are placed a lens for the focusing of the light rays
30 and a polarization
filter 41, whereby as shown in Fig. 6 a light source (not described) radiates
light 38 in an axial
direction through lens 40 and polarization filter 41. The device with this
kind of light 38 emission
is especially designed for the treatment of small tissue areas, e.g.
acupuncture points.
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CA 02363383 2001-11-13
In the field of dermatology, light is used as a stand-alone therapy for
wounds, leg ulcers, eczema,
bums, etc., and as such is used to stimulate tissue directly. Light may also
be used to treat tissue
using photodynamic therapy (PDT) by activating chemical reactions in
photosensitive chemicals
introduced into or onto the tissue, such as photofrin, S-aminolevulan acid,
hematoporphyrin,
verteporfin, chlorins, phthalodyanines, phenothiazine, and benzoporphyrin-
derivative monoacid-
A (A TMPn) etc. for healing solar keratoses, basal cell carcinoma, melanomas,
etc.
PDT substances may be administered in various forms: lotion or cream for
topical application,
tablets or capsules for oral injection, and local injection of solutions.
Dimethylsulfoxide (DMSO) is a solution which has the property of breaking down
the barrier of
the skin and is often used before- administering PDT substances in order to
increase the
absorption thereof. Alternatively, PDT substances may be mixed with DMSO for
application to
the skin.
An instrument consisting of a handle with a head, wherein a number of needles
connected to a
spring arrangement can be used to pierce small, closely distanced holes in the
upper layer ofthe
skin before the PDT substances are applied, in order to increase and
accelerate the absorption.
Treatment by light irradiation with the inventive device should not commence
until sufficient
absorption by the target tissue is obtained. Simply waiting for empirically
determined times to
elapse can suffice, or photodynamic diagnostic (PD) may be employed to
determine absorption.
PD comprises viewing the target area under illumination of a particular
spectral content (such as
fibm a fluorescent wood lamp) and observing apparent colour of the target
tissue.
High-intensity treatments (higher doses of PDT substances and strong
irradiation) are used where
it is desired to destroy tissue, as in destroying tumor tissue to cure cancer,
or in hair removal
where it is desired to destroy the hair follicle. Low-intensity treatments are
used where it is
desired to energize affected cells and to stimulate the local immune system,
as in the
rehabilitation of epicondylitis, tendinitis, arthritis, arthroses, gout, and
pulmonary diseases; or in
the treatment of acne, actinic keratoses, warts, onychomycosis, psoriasis,
dermatitis, and basal
carcinoma; and in improving the appearance of wrinkles, cellulite, and fat
deposits.
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CA 02363383 2001-11-13
Low-intensity treatments have been observed to activate aspects ofthe local
immune system such
as the macrophages, which produce prostaglandine E2 (PGE2) and TNF (pro-
inflammatory
zytokines). There have also been observed an accumulation of leucozytes in the
venoles, and
higher activity of the lymphozytes and plasma cells in the skin. The residual
5 content TNF-a of
pro inflammatory zytokines has been detected in the urine of patients after
having PDT treatment.
Treatment with the inventive device further enhances the efficacy of medicinal
substances by
photo-phoresis, a process of propelling fluids into the skin or tissue and
propelling molecules
through cell walls. The absorption process is speeded up, and amount of PDT
substance
absorbed is increased. Other methods of phoresis are in use, such as galvanic-
iono-phoresis,
exchange phoresis, and phono-phoresis. These methods create a concentration
gradient across the
skin, and a resultant Brownian molecular motion creates a thermal influence
which enhances
transfer of medicaments. However, this warming may be uncomfortable, and may
render
impossible a facelift using a collagen face-mask, since collagen will not
withstand temperatures
above 27 degrees Celsius.
Photofrin is PDT substance which is administered by injection, at a dosage of
1 - 2 mg. per kg. of
the patient's weight. 48 hours is allowed for absorption of the photofrin by
the tissue to be treated,
during which time the patient is kept in dim light. The treatment consists of
irradiation by the
inventive device. The patient remains photosensitive for 6 to 8 weeks, and
should avoid strong
light and direct sunlight during that time.
ALA (5-Aminolavulinacid) is externally applied as a 10 to 20 percent mixture
in an oil in water
emulsion or in a cream. 4 to 6 hours is allowed for absorption, during which
time the patient
should remain in dim light. After treatment by irradiation from the inventive
device, the patient
remains photosensitive for 24 to 48 hours, during which he should avoid strong
light and direct
sunlight.
L-Phenylalanin is applied in liquid form as a lotion or a spray or in a cream
form, in a 5 to 30
percent mixture according the severity of the condition to be treated. Optical
irradiation with the
inventive device may begin almost immediately. Alternatively, doses of 50 to
100 mg may be
13
CA 02363383 2001-11-13
taken orally 30 to 60 minutes before irradiation. The patient is
photosensitive for 24 hours after
application.
Ammi visnaga is an herbal substance obtained from a dried extract of the fiuit
ammeos visnagae
fi~uctus. Its molecular structure is depicted in Fig. 10. Fluid application of
a S to 30 percent
mixture (according to pathology) in the form of a lotion, spray, or cream is
performed shortly (30
minutes) before irradiation, or an oral dose of 100 mg. is given 2 to 3 hours
before irradiation.
The patient need not be kept in a darkened room before irradiation, and may be
subjected to
normal incidence of direct sunlight immediately after treatment.
Tests indicate that ammi visnaga solution prepared in the homeopathic manner
is effective at
lower concentrations, which is advantageous both from the standpoint of
economics (the amrni
visnaga extract may cost several dollars per gram) and because of a lowered
risk oftoxicity (side
effects). In a homeopathic preparation, the herb is first micronized and a
weak solution in a fluid
medium such as alcohol, sterile water, or oil (glycerine) is prepared and
bottled. Vibrations are
introduced into it by concussing the bottle repetitively against a medium-hard
surFace such as a
rubber plate on a table, or by subjecting the bottle to low- fi~equency (1 to
500 Hz.)
electromagnetic vibrations, which pulls energy out of the micronized herb into
the entire
solution. The solution must be prepared so that the molecule size is
comparable to that for amino
acids, so that the molecules may easily permeate cell membranes.
PDT has been used successfully in the treatment of internal inoperable
cancers. A
biopharmaceutical (specifically, hematoporphyrin) is injected into the
tumortissue, and an optical
method known as photodynamic diagnostic (PD) is used to determine when the
biopharmaceutical has been absorbed by the entire tumor. Then the tumor tissue
is irradiated with
light typical for a dye laser, which activates the photosensitive reactors in
the hematoporphyrin,
whereby singlet oxygen is liberated. Singlet oxygen is toxic to protein and
phosphor lipids in the
tumor tissue, whereby the tumor is destroyed without destroying the
surrounding tissue.
For treatment of skin keratosis (precancerous tissue), trials with, for
example, 5- aminolevulinic
acid have shown that it can be used effectively in PDT if introduced into oil
in a water suspension
14
CA 02363383 2001-11-13
which is then applied to skin keratosis and then irradiated with a light
source. A fast and
cosmetically perfect healing has been attained with a very low rate of
recurrence compared to
conventional treatments, such as cryotherapy.
Common dermatological diseases like acne, warts, onycho-mycosis (nail fungus)
and wrinkle
treatment can be successfully and effectively treated using PDT (with ALA/5-
aminolevulanic
acid) at a lower concentration than has conventionally been used. The
treatment works not by
causing cell death as light treatment has historically done, but instead works
by stimulating the
immune system so as to enable it to better control the inflammatory reaction
to oil gland activity.
The irradiation at multiple wavelengths as provided by the present invention
enhances the
efficacy of treatment in this manner.
Stimulating the immune system so as to reduce inflammatory reactions has also
been found
effective in the therapy of many other conditions, for example, epicondylitis
(tennis elbow),
tendinitis, gout, arthritis, arthroses, pulmonary diseases, and numerous other
muscular and joint
symptoms. Good results have been obtained with PDT in conjunction with the
present
invention's multiple wavelength output. Studies indicate that the patient
often is pain-free after
only one treatment, and the number of treatments can be reduced to 3 - 4,
instead of 12 - 20 as
required without the inventive device.
The PDT substance is applied topically as cream or oil in water suspension,
typically a 10 - 20
percent solution. Augmented action may be obtained by use of injection instead
of or in addition
to topical application. A large joint such as the knee requires 10 - 12
subcutaneous or intra-
muscular injections, preferably at the trigger points, while for a smaller
joint such as the elbow 5 -
6 injections is su~cient. First the trigger points are found and irradiated
for 30 seconds with hand
applicator of the present invention. This gives an anaesthetic effect, which
is useful for lessening
discomfort from the injections. (Injection at the trigger points is known for
reduction of pain).
Then, after determination that the PDT substance is absorbed by the target
tissue, the surface
applicator of the present invention is folded around the target joint and
irradiation takes place for
CA 02363383 2001-11-13 ,
..
30 minutes. Ammi visnaga can be selected as a homeopathic PDT solution both
for topical use
and for the trigger-point injections.
Good results have also been obtained in the physiotherapy and physical
rehabilitation with the
present invention ability to radiate visible light in conjunction with several
wavelengths of
infi~ared light which is able to penetrate to deep tissue.
Fig. 8, in connection with Fig. 9, describes a hand applicator 1 Sb, which is
especially intended for
dental treatment. The applicator 1 Sb shows at the finnt end of the shaft 42 a
printed circuit board
43, where an IR semiconductor diode (IR infi~.red light) 44 and a
semiconductor diode (blue
light) 45 are placed, where the diode 44 is stimulated to radiate light with
the described three
wavelengths and the diode 45 is stimulated to radiate the described wavelength
range of 350 -
500 nm. In front of the printed circuit board 43 a head piece 46 is placed,
connected with a
fastened hollow expander 47, in which an optical fibre is sealed (not shown).
The head piece 46
is in front of the printed circuit board 43 so it can be rotated 180°,
so that the expander 47 can be
positioned in front of either the diodes 44 or 45. If the expander 47 is
positioned, for example, in
fibnt of the diode 44, light with the wavelengths 600, 900 and 1200 nanometer
is transmitted
through the optical fibre in expander 47 and ultimately strikes the tissue,
e.g. gum tissue, through
which painful gingival diseases can be eliminated. Through a positioning ofthe
expander 47 in
front of the blue light semiconductor diode 45, blue light is conducted
through the expander 47,
with which plastic fillings in teeth can be hardened. It is obvious that the
light rays with this form
of execution can also be conducted through polarization fibers. Furthermore,
the two hand
applicators are equipped with sensors 32 for the same purpose as described for
the
applicators 13. The control unit of the present invention causes output of the
blue light to be at
25 % of full output for the first ten seconds, and full power thereafter. This
results in better
hardening of the fillings, without shrinkage.
Fig.l l Shows a diagram of the air-pressure unit 48, which can either be built
into the control
mechanism of the device or produced as a separate device connectable with the
invented
photodynamic stimulation device. The air unit can either be produced as a
rechargeable alr-tank
16
CA 02363383 2001-11-13
or as a small air-compressor with container. The container outlet is equipped
with a reduction
valve 51, combined with a pressure meter 52, well known of their ark The
electronic valve 51 a in
the air tube 49 leading to the hand applicator 50 can be switched on fi-om the
hand applicator and
the ON impulses can be regulated at the control mechanism 53 . The current
impulses 63 and
amplitude 64 for the ionto-phoresis treatment are also adjustable at the
control mechanism.
Fig.l2 lllustrates an exchangeable mund head 56 for the hand applicator, which
can be
exchanged by a click in bracket (not illustrated). The treatment head 56 is
changeable according
to the purpose of radiation, so that a round head could be used for treating
round spots, while a
rectangular head 56a would be preferable for treating wrinkles.
Fig.13a The hand applicator is illustrated in a bottom view, mounted with a
rectangular treatment
head 56a. Next to treatment head the semiconductor and or laser diodes 17,
17a, 18 is placed in
rows covered of a polarization filter 37 and/or lens system. There is also
integrated a sensor 32
for feedback measurement.
Fig.l3b shows a drawing of the hand applicator 50, which can be used for the
following
purposes:
- Introducing light-reactive substances to the tissue with the aid of air-
pressure pulses
- Introducing light-reactive substances to the tissue by help of ionto-
phoresis
- Radiating the tissue with a mix of light radiation which can be selected at
the control
mechanism.
The hand applicator contains a valve 55 placed just after the air inlet,
prohibiting the substances
finm nmning back into the air tube 49. The treatment head is mounted with a
sensor 57
permitting exposure only on skin contact and fiuthermore the head also
contains a valve-system
58 which opens only on skin contact, thus preventing the substances firm
running out ofthe head
before it touches the skin.
The chamber 59 containing the substances is placed next to the air duct in the
hand applicator 50
and the chamber is connected with a dosage pump 60, so that the amount of
substance per air-
shot can be dosed very accurately.
17
CA 02363383 2001-11-13
The hand applicator's 50 housing is made of an insulating material, and the
treatment head 56 is
made of an electrically conductive material so that it can also be used for
ionto-phoresis
treatment combined with air-pressure treatment in order to attain maximum
absorption.
Around the treatment head the semiconductor and/or laser diodes 17, 17a, 18
are placed for the
selective light radiation.
The ON/OFF switches 54, 61, 62 for operating the hand applicator are placed on
the top of the
applicator. During the ionto-phoresis treatment the patient must hold an
electric conductor 65
handle in his hand.
Thus, while there have been shown and described and pointed out fundamental
novel features of
the invention as applied to a preferred embodiment thereof, it will be
understood that various
omissions and substitutions and changes in the form and details ofthe devices
illustrated, and in
their operation, may be made by those skilled in the art without departing
from the spirit of the
invention. For example, it is expressly intended that all combinations of
those elements and/or
method steps which perform substantially the same function in substantially
the same way to
achieve the same results are within the scope ofthe invention. Moreover, it
should be recognized
that stmctures and/or elements and/or method steps shown and/or described in
connection with
any disclosed form or embodiment of the invention may be incorporated in any
other disclosed or
described or suggested form or embodiment as a general matter of design
choice. It is the
intention, therefore, to be limited only as indicated by the scope of the
claims appended hereto.
18
