Note: Descriptions are shown in the official language in which they were submitted.
LASER ASSISTED WOUND HEALING PROTOCOL AND SYSTEM
CROSS REFERENCES
This application is an International Application claiming priority to CIP
Patent Application
No. 15/348,793 filed November 10, 2016 claiming the benefit of priority under
35 U.S.C. 120
from U.S. Patent Application No. 14/937,858 filed November 10, 2015 which
claims the benefit
of priority from U.S. Patent Application No. 13/864,226 filed April 16, 2013,
now issued Patent
No. 9,180,319, which claims the benefit of priority from U.S. Patent
Application No. 13/078,757
filed April 4, 2011.
FIELD OF THE INVENTION
The present invention relates generally to a method of treating gum diseases
using a diode
laser which produces a beam of light having a wavelength in the visible
portion of the
electromagnetic spectrum (400nm - 700nm). Optionally, the laser light utilizes
green wavelength
range (520nm - 570nm) at a laser power 0.001 W to 5W to treat wounds. It is
also contemplated
that described is a method of treating diseased tissue using a diode laser.
Optionally, the laser light
utilizes the IR wavelength range (700nm - 1400nm) at a laser power of .001W to
5W to treat
wounds. Optionally, an LED light utilizes the IR wavelength range to treat
wounds.
BACKGROUND OF THE INVENTION
Laser Assisted Periodontium and Osseous Regeneration (LAPOR) is a protocol
which is
laser assisted with the use of a substrate such as but not limited the LAPOR
periodontal solution,
the LAPOR periodontal gel and the LAPOR substrate and thus causes an increase
in cell
attachment of epithelial cells, gingival fibroblasts, PDL fibroblasts and
adhesion of osteogenic
cells. Enhanced cell migration and proliferation appears to lead to
accelerated wound fill rates in
vitro using PDL fibroblasts, gingival fibroblasts and osteoblast-like cells.
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A substrate such as the LAPOR periodontal solution, the LAPOR periodontal gel.
and the
LAPOR substrate, used in the LAPOR protocol, stimulates total protein
synthesis and the synthesis
of specific extracellular matrix molecules. Studies that evaluate the bone
remodeling regulation
system indicate that proteins influence this regulation system, thus
indicating an indirect
involvement in the bone remodeling process. When used in conjunction with
three specially
formulated periodontal and wound healing substrates, and LAPOR gel root
conditioner, LAPOR
has shown to stimulate total tissue and bone synthesis, increase gingival
attachment, gingival
height, bone density, bone height thereby showing accelerated wound till rates
in vivo.
The diode laser used produces a beam of light having a wavelength in the
visible portion
of the electromagnetic spectrum (400mn ¨ 700nm), Optionally, a beam of light
having a
wavelength in the green wavelength range (520 ¨ 570 nm) at a laser power of
0,5 to 1.2W is used
in the LAPOR protocol. It has been shown by the LAPOR protocol to biostimulate
the healing and
regenerative processes of the neriodontiumõ including the biostimulation of
new bone and its
supporting elements. The diode laser used in the LAPOR. protocol,
biostimulates the healing
response of the peTiodontium nonsurgi.cally, and biostimulates the tissue
regeneration of the
periodontium, nonsurgically, and prcvent6 long j turd:lona' c,-pithelium from
migrating downwards
into the sulcus (a biomechanical aspect of tissue healing), thereby preserving
the tissue height. A
diode laser used in the LAPOR protocol helps a substrate such as but not
limited to proteins to
stimulate total protein synthesis and the synthesis of extracellular matrix
molecules, nonsurgically.
Alternatively, the LAPOR protocol may use a beam of light having a wavelength
in the
green wavelength range (520-570 rim), red wavelength range (620-750 mu), or
yellow wavelength
range (570-590 ran) having an alternative wattage of 0,001W to 5W, preferably
0,002W to 4W,
more preferably 0.003W to 4W, and most preferably 0.005W to 2W. The diode
laser used helps
the substrates stimulate total tissue and bone synthesis by biostimulating the
healing response and
bone/tissue regeneration and its supporting elements of the wound.
It is further contemplated that the invention may be used to treat tissue
damage and wounds,
i.e. Laser Assisted Tissue and Osseous Regeneration (LATOR) using a solution,
LA.TOR gel and
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LATOR substrate to enhance cell migration and proliferation leading to
accelerated wound fill
rates. The protocol is used in conjunction with six specially formulated
tissue and wound healing
substrates and a gel conditioner to stimulate total tissue and bone synthesis,
increase tissue
attachment, tissue height, hone density and bone height thereby showing
accelerated would fill
rates like the LAPOR protocol..
SUMMARY OF THE INVENTION
In an exemplary embodiment of the present invention, there is disclosed a
method of
treating wounds, including gum disease and gingival tissues post scaling/root
planning, using a
diode laser which generates a beam of light having a wavelength in the visible
portion of the
electromagnetic spectrum (400nm ¨ 700nm). Optionally, a beam of light having a
wavelength in
the green range (520 ¨ 570 am) at a laser power of 0.5 to 1.2 watts is used to
decontaminate the
gum tissue and to biostimulate healing and regenerate the periodontium
(including cemenhim of
the root surface), thus preventing long junctional epithelium from migrating
downwards into the
sulcus and thereby preserving the tissue height. Alternatively, a beam of
light having a wavelength
in the green wavelength range (520-570 mu), red wavelength range (620-750 nm),
or yellow
wavelength range (570-590 am) having an alternative wattage of 0.001W to 5W
may be used to
hiostinaulate healing and regenerate the wound site, its tissue and bone. In a
preferred embodiment,
the wattage is in the range of 0.002W to 4W, more preferred in the range of
0.003 to 3W, and most
preferred in the range of 01)05W to DAL A diode laser also biostimulates the
healing and
regenerative response induced by a substrate, i.e. the LAPOR periodontal and
wound healing
solution, the LAPOR periodontal gel and the LAPOR periodontal and wound
healing substrates,
the method comprising: 1) placing the laser inside the sulcus; 2) penetrating
the entire micas by
moving the laser light intermittently vertically and horizontally throughout
the sulcus; and 3)
placing the substrate in the sulcus prior to a blood clot forming (which then
increases cell
attachment, adhesion, migration and proliferation). In a preferred embodiment,
the LATOR
protocol may use a diode laser per the above parameters to treat general wound
sites. Optionally,
the laser light utilizes the IR wavelength range (700nm ¨ 1400nni) at a laser
power of .001W to
5W to treat wounds.
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In an alternative embodiment, the LAPOR, protocol may use an LED light to
biostitnulate
healing and regenerate periodontium and general wound tissue (LATOR protocol).
The LED light
is used at IOW or lower on wounds to assist in new cell organization and hence
tissue regeneration.
Optionally, an LED light utilizes the IR wavelength range to treat wounds.
Optionally, the laser
light utilizes the IR wavelength range (700iirn ---- 1400m) at a laser power
of .001W to 5W to treat
wounds.
In an alternative embodiment, the LAPOR and LATOR protocols may use a
radiofrequency (RF) wave to decontaminate the gum tissue and biostimulate
healing and
regenerate the periodontium, The 'RT. beam is used at 10W or lower on wounds
to assist in new
cell organization and hence tissue regeneration. A carrier wave (sine wave)
transpol ts a non
sinusoidal waveform to the treatment location. The canier wave frequency may
be in the range
of 0.1MHz to 20MHz while the non-sinusoidal waveform may be in the range of 0
to 40 KHz or
alternatively O- 24 GElz, In a preferred embodiment, the carrier wave
frequency is in the range
of 0.2N11-1z to 10MHz, preferably 0.3MHz to 5M-Hz. Optionally the 0.001W to 10
watt range,
preferably a (1001W to 3W range, is utilized in the hertz range of 40 Hz to 24
Gliz, In a fuither
alternative embodiment, the RF wave is a single sine wave. In a further
alternative embodiment,
the RF wave is more than one sine wave Wherein the more than one demonstrates
a hamionics
pattern. In a preferred embodiment, the LATOR protocol may use an RF wave per
the above
parameters to treat general wound sites. Optionally, the non-sinusoidal
waveform may be in the
range of the above parameters in the absence of a carrier wave.
In another embodiment of the present invention, there is disclosed a
root/bone/cartilage
conditioner comprised of EDTA 15%, calcium gluconate 20%, rnethylparaben,
propylparaben,
Ethanolamine as a buffering agent, carboxymethyleellulose, and green food
coloring and sterile
water.
In still another embodiment of the present invention, there is disclosed It
.first substrate
comprised of: a combination of mono or disodium phosphate and sodium hydroxide
in solution
with a sodium content of 1 lmg/100g; 60% water; 9% Lysine; 9% Proline; 9% all
other essential
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amino acids wherein the amino acids are chosen from the group consisting of
Isoleucine, Leucine,
Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Histadine,
Asparaginc and
Seleriocysteine; 2% of all other rion-essential amino acids wherein the amino
acids are chosen from
the group consisting of Alanine, Argniinc, Aspartate, Cy-steine, Glutamate,
Glutamine; Glycine,
Serine, Tyrosinc and Pyrrolsine; 6.9% free bases wherein the free bases are
chosen from the group
consisting of adenosine, oridine, guanosine, iridin and cytidine; 2%
phosphates wherein the
phosphates are chosen from the group consisting of .ADP, ATP and
etcetycholine; and I% benzoic
acid.
In still another embodiment of the present invention, there is disclosed a
second substrate
comprised of: tricalcitun phosphate wherein the tri calcium phosphate is
precipitated with calcium
hydroxide/Claw oil; and hydroxyapatite crystals.
In yet another embodiment of the present invention, there is disclosed a third
substrate
comprised of: 5.1 % hyaluronic acid; 8% fatty acids wherein the fatty acids
are chosen from the
group consisting of Linoleic acid (LA), alpha-linolenic acid (ALA), 4.4%
sugars wherein the
sugars are Chosen from the group consisting of mannese, galactose, N-
acetylglactosamine, 1\1-
acetylglucosalaiinc, N-acetyhteuraininic fucuse (L configuration minus a
carboxyl group at
the 6 position), and xylose; 2.2% mixture of glucose and fueose (L
configuration minus a carboxyl
group at the 6 position); 3% lipids wherein the lipids are chosen from the
group consisting of
vitamin A, vitamin D2, D3, vitamin E, vitamin K1, K2, vitamin B12
(tnctilylvebalamin,
hydroxocobalamin), cholesterol, and diaglycerol; 2.7% vitamins wherein the
vitamins are Chosen.
from the group consisting of vitamin B1, vitamin132, vitamin B3, vitamin 135,
vitamin 136, vitamin
137, vitamin 139, vitamin C and pantothenic acid; 4.5% electmlyte sources:
wherein the electrolyte
sources are chosen from the group consisting of Calcium Chloride, Choline
Chloride, Magnesium
Sulfate, Potassium Chloride, Potassium). Phosphate (monobasic), Sodium
Bicarbonate, Sodium
Chloride, and Sodium Iodide; 6% metals wherein the metals are chosen from the
group consisting
of Ag nanoparficles and Au nanoparficies; 3.9% ionic metals wherein the ionic
metals are chosen
from the group consisting of copper, zinc, selenium, iron, manganese, cobalt,
chromium, boron,
and molybdenum; and 4% other ionic metals wherein the other ionic metals are
chosen from the
group consisting of boron, silicon, nickel and vanadium.
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In another embodiment of the present invention, there is disclosed a fourth
substrate
comprised of carbomer, potassium chloride, chloride, sodium, potassium,
manganese, calcium tri-
phosphate, sulfate, carbonate, snail serum, snail secretion filtrate, HA, Au,
A& Cu, Fe, Pt,
collagen, glyceine HO and fucose.
In another embodiment of the present invention, there is disclosed as fifth
substrate
comprised of a tricalcium phosphate andlor collagen limed andior collagen
unlimed.
In another embodiment of the present invention, there is disclosed a sixth
substrate
comprised of tricalcium phosphate and/or collagen limed and/or collagen
unlimed and/or HCI
and/or NaCl, and/or metals wherein the metals are chosen from the group
consisting of copper,
Au, Ag, iron and platinum or any combination thereof,
The more important features of the invention have thus been outlined in order
that the more
detailed description that follows maybe better understood and in order that
the present contribution
to the art may better be appreciated. Additional features of the invention
will be described
hereinafter and will form the subject mania of the claims that follow.
Before explaining at least one embodiment of the invention in detail, it is to
be understood
that the invention is not limited in its application to the details of
construction and the arrangements
of the components set forth in the following description or illustrated in the
drawings. The
invention is capable of other embodiments and of being practiced and carried
out in various ways.
Also, it is to be understood that the phraseology and terminology employed
herein are tbr the
purpose of description and should not be regarded as limiting.
As such, those skilled in the art will appreciate that the conception, upon
which this
disclosure is based, may readily be utilized as a basis for the designing of
other structures, methods
and systems for carrying out the several purposes of the present invention, It
is important,
therefore, that the claims be regarded as including such equivalent
constructions insofar as they do
not depart from the spirit and scope of the present invention.
6
According to an aspect of the invention is a system for healing soft tissue
comprising:
(a) an instrument comprising a hand piece with at least one opening through
which a
radiofrequency (RF) wave is transmitted;
wherein the at least one opening from the hand piece of the instrument is for
positioning directly or in close proximity to the soft tissue of an
individual;
wherein the RF wave is configured for bio-stimulating the soft tissue and for
controlling a temperature of the soft tissue, and
wherein the RF wave has a wattage of less than .5 W; and/or
(b) a laser configured to generate a beam of light having a wavelength
from about
400 nm to about 700 nm, wherein the beam of light exits the instrument through
the at least one
opening, wherein the beam of light is also configured for bio-stimulating the
soft tissue and for
controlling the temperature of the soft tissue;
a power source to operate the instrument to generate the RF wave and/or the
laser; and
a substrate comprising collagen, 200mg to 6g hyaluronic acid, water, 0.1g to
lg Cu,
0.1g to 1g Fe, and 0.1g to 1g silver,
wherein the substrate, in combination with the RF wave and/or the beam of
light, is for
healing the soft tissue.
6a
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The foregoing has outlffied, rather broadly, the preferred feature of the
present invention
so that .those Skilled in the art may better .understand the detailed
description of the invention that
follows. Additional features of the invention will he described hereinafter
that form the subject of
the claims of the invention. Those skilled in the art should appreciate that
they can readily use the
disclosed conception and specific embodiment as a basis for designing or
modifying other
structures for carrying out the same purposes of the present invention and
that such other structures
do not depart from the spirit and scope of the invention in its broadest form,
BRIEF DESCRIPTION OF THE DRAWINGS
Other aspects, features, and advantages of the present invention will become
more fully
apparent from the following detailed description, the appended claim, and the
accompanying
drawings in which similar elements are given similar reference numerals.
Fig. I shows an X-Ray view of a patient's teeth before treatment with a diode
laser before
a substrate has been applied.
Fig. 2-7 Show X-Ray views of the lower teeth of Fig. 1 after treatment with a
diode laser
after treatment with a substrate.
Fig. 8 shows an X-Ray view of the upper teeth before treatment with a diode
laser after
treatment with a substrate.
Fig. 9 shows an X-ray view of the upper teeth of Fig. 8 after treatment with a
diode laser
after treatment with a substrate.
Fig. 10 shows a flow diagram of a method of using a diode laser to treat gum
disease in
accordance with the principles of the invention.
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Fig. 11 shows bone density measurements for tooth 15 of a patient. at 12 loci
on the tooth
following treatment with a diode laser and a substrate over time,
Fig. 12 shows bone density measurements for tooth 28 of a patient at 17 loci
on the tooth
following treatment with a diode laser and a substrate over time.
Fig 13 shows bone density measurements for tooth 2, tooth. 3 and tooth 15 of a
patient at
3 loci per tooth following treatment with a diode laser and a substrate over
time.
Fig 14a and 14b show X-rays of tooth 1.5 of a patient from which measurements
shown in
Fig. 11 were collected. (a) shows tooth 15 'before treatment, (b) shows tooth
15 at the October
2011 measurement following three treatments.
Fig. 15a and 15b show X-rays of tooth 28 of a patient from which measurements
shown in.
Fig. 12 were collected, (a) shows tooth 28 before treatment. (b) shows tooth
28 at the January
2011 measurement following four treatments.
Fig. 16a and 16b Nhow a panoramic X-ray of tooth 2, tooth 3 and tooth 13 of a
patient from
which measurements shown in Fig. 13 were collected. (a) shows the teeth before
treatment. (b)
shows the teeth at the July 2011 measurement.
Fig. 17a-17f show various views of a first embodiment of a diode laser of the
present
invention, (a) shows a right side view. (h) shows a back side view, (c) shows
a left side view,
(d) shows a front side view, (e) shows a top view, (f) shows a bottom view.
Fig. 18a-18c show as exploded view of the diode laser of Fig. 17. (a) shows an
exploded
view, (b) shows an assembled view, (c) shows a close-up of the laser housing.
Fig. 19a49g shows various views of a second embodiment of a diode laser of the
present
invention, (a) shows a top perspective view. (b) shows a back view. (e) shows
a left side view.
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(d) shows a top view. (e) shows a front perspective view. (t) shows a right
side view. (g) shows
a bottom view.
Fig. 20a arid 20b an exploded view of the diode laser of Fig. 19. (a) shows an
exploded
view. (b) shows a close-up of the laser housing.
Fig. 21a-21c show various view of a third embodiment of the diode laser of the
present
invention. (a) shows a side perspective view. (b) shows an exploded view. (c)
shows a close-up
view of the laser housing.
Fig. 22a-220 shows a fiber optic laser of the present invention. (a) shows an
assembled
view. (b) shows an exploded view, (c) shows a fully ass. bled la.ser.
Fig. 23 shows a flow chart of the protocol for using a laser of the present
invention.
Fig. 24 Shows chin profile measurements before and after treatment,
Fig. 25 shows toe crease length mcastuments hefure and after treatment
Fig. 26a-26c show gingival wound healing and tissue regeneration measurements
before
and after treatment (a) shows wounds before treatment. (b) shows tissue
regeneration after
treatment. (c) shows tissue height measurements before and after treatment.
Fig. 27 shows hand crease length measurements before and after treatment.
Fig. 28 shows wound new skin growth measurements before and after treatment.
Fig. 29 shows (anal) scar width reduction measurements before and after
treatment.
Fig. 30 shows (anal) scar length reduction measurements before and after
treatment.
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Fig, 31 shows swallowing strength measurements before and after treatment.
Fig. 32 shows breast firmness measurements before and after treatment.
Fig. 33a-33e show various views of an RF hand piece of the present invention,
(a) shows
a top view. 09 shows a side view. (e) shows a perspective view of the RF tips,
(d) shows an
exploded side perspective view. (e) shows an alternative side perspective
view.
Fig. 34a-34f show various views of a fourth alternative diode laser of the
present invention.
(a) shows a right side view. (b) shows a front view. (c) shows a left side
view. (d) shows a left
side perspective view. (e) shows a top view, (0 shows a right side perspective
view.
Fig, 35a-35f show various views of a laser power source for the fiber optic
hand piece and
interchangeable tips.
Fig. 36a-36f shows various views of a portable RF transmitter of the present
invention. (a)
shows a top view. (b) shows a front view. (0) shows a bottom view. (d) shows a
left side view.
(6) shows a left front perspective view. (f) shows a right front perspective
view.
Fig. 37a-37b show alternative fiber optic lasers of the present invention. (a)
shows a fiat
(b) shows a glass dispenion tip.
Fig. 38 shows epithelial wound regeneration before and after treatment.
Fig. 39 shows cancaeal tendon wound regeneration before and after treatment.
Fig. 40 shows ankle epithelial wound regeneration before and after treatment.
Fig. 41 shows ankle wound size reduction before and after treatment.
Fig. 42 shows oral cavity wound regeneration before and after treatment,
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Fig. 43 a-b shows (a) vein wound regeneration before and after treatment and
(b) a flashlight
style infrared Iant.
DETAILED DESCRIPTION OF THE INVENTION
Definitions
As used herein, the term "gum disease" means periodontal disease which can
lead to tooth
loss and/or other health problems. Examples of periodontal disease include
gingivitis, aggressive
periodontitis, chronic periodorititis, periodontitis as a manifestation of
systemic diseases, and
necrotiArig periodontal disease.
As used herein, the term "tissue disease" means tissue and/or epithelial loss
due to injury
and/or wounds which can lead to other health problems such as amputation of
limbs.
As used herein, the term "patient" means any individual suffering from a
disease of the
gums and in need of treatment for said gum disease.
As used herein, the term "locus" means an exact point of measurement within
the sulcus
or the immediate surrounding area.
As used herein, the term "substrate mixture" means the mixture of the first
substrate and/or
the second substrate and/or the third substrate and/or the fourth substrate
and/or the MI substrate
and/or sixth substrate disclosed herein for treatment of gum disease and/or
tissue disease and/or
wounds.
As used herein, the term "bone regeneration" means increasing the density of
calcium at
specific loci in or around the suleus,
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As used herein, the term "calcium density means the measurement of calcium
mass
around a given loci.
As used herein the term "wound" means any area that has lost any original
tissue or bone
or any other structure not named that lost a healthy non-wounded, undamaged
and unaged form.
The LAPOR protocol can be .used in the treatment of gum disease and wounds by
combining the most effective methods of treatment with the use of a special
laser. Approximately
66% of the United States population has some form of gum disease. But many
avoid seeking
treatment because of the discomfort that often results from gum surgery. LAPOR
provides a new
choice The LAPOR protocol is a treatment that is more effective as traditional
periodontal.
surgery, and it is much more beneficial to the patient both in the short term
and in the long mil
The LATOR protocol can similarly be used for treatment of tissue disease and.
wounds.
The LAPOR protocol takes only about an hour and only two short follow-up
visits. Patients
enjoy no downtime with recovery taking only 24 hours. This makes immediate
return to work both
possible and oomfiniable.
After having the LAPOR protocol performed, gum recession is zero when compared
to that
which most often follows nonnal periodontal surgery, This, combined with new
cementuni
.formation on the roots, hone formation in previous defects, periodontal
ligament formation and no
tooth loss. After having the LATOR protocol performed, wound fibrosis is zero
compared to that
which most often follows normal treatment, new tissue formation occurs multi
directionally and
the wound closes without grafting.
The LAPOR protocols of the present invention can be used to heal wound sites
by
combining or using separately the most effective methods of treatment with the
laser, LED,
radioliequ.ency energy and substrates. Following performance of treatment
protocols, no
receding of tissue from the wound site was observed. in a preferred
embodiment, the RF energy
waves may be up to 10W. The carrier wave frequency may be in the range of
0.1MHz to
201µ41-1z while the non-sinusoidal waveform may be in the range of 0 to 40 KHz
or from 0 to
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24GHz, In a preferred embodiment, the carrier wave frequency is in the range
of 0.21V1Hz to
10MHz, preferably 0,3MHz to 5X41-/z. Optionally a 0.001W to 10W range RF
energy, preferably
a 0.00IW to SW range, is utilized in the hertz ranee of 40 Hz to 24 In a
farther alternative
embodiment, the RF wave is more than one sine wave wherein the more than one
demonstrates a
harmonics pattern.
The special type of laser used in the LAPOR protocol and the ',AMR protocol is
the diode,
a semiconductor coherent light beam used on s. The laser light used has a
wavelength in the visible
portion of the electromagnetic spectrum, between 400nrn 700run wavelength.
Optionally, the
green range (520 570 ritn) of the visible spectrum is utilized at a laser
power of 0.5 to L2 watts,
which disinfects the site, leaving the gima tissue bacteria free, and
biostimulates healing; in.
conjunction with treatment with a substrate, the laser biostimulates
regeneration of the
periodontiura. Traditional periodontal therapy removes tissue height of a
tooth to reduce the pocket
depths. The LAPOR protocol is a regenerative procedure. The patient does not
lose tissue volume.
Tissue volume is increased and bone is regenerated. For general tissue
disease, the laser
biostimulates regeneration of tissue where traditional therapy removes tissue
height to reduce the
disease. Optionally, the laser light utilizes the IR wavelength range (700nm ¨
1.400nm) at a laser
power of .001W to 5W to treat wounds. Optionally, LED light is used at 10W or
lower.
The use of the diode laser in conjunction with routine sealing and root
planning is more
effective than sealing and root planning alone. It enhances the speed and
extent of the patients
gingival healing and postoperative comfort. This is accomplished through laser
bacterial reduction
and biostimulatiori with a laser light having a wavelength in the visible
portion of the
electromagnetic spectrum, between .400nin 700nin wavelength_ Optionally, the
green range (520
¨570 um) of the visible spectrum is utilized at a laser power of 0_5 to 1.2
watts. Alternatively, the
laser power wattage may be in the range of 0.001W to 5W, preferably 0.002W to
4W, more
preferably 0.003W to 3W, and most preferably 0.005W to 2W.
Referring to Fig. 10, there is disclosed a method 10 of using a diode laser
which produces
a beam of light, used intefinittently, having a wavelength in the visible
portion of the
electromagnetic spectrum, between 400nrn¨ 700nrn wavelength. Optionally, the
green range (520
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¨570 run) of the visible spectrum is utilized at a laser power of 0.5 to 1.2
watts to treat gam disease.
Starting at block 12, a petio probe determines the degree of excessive pocket
depth and thus helps
the dentist better identify diseased tissue and areas of bacterial infection.
The dentist removes
calculus from the root surface using an ultrasonic scaler and hand
instruments, block 14. This
action by the dentist helps stimulate a healing response in the sulcus by
opening the capillaries
upon scaling Going to block 18, the laser tip is placed inside the sulcus and
a continuous light
beam with intermittent stops for tissue temperature control is allowed to
penetrate the entire sulcus
by moving the tip vertically and horizontally throughout the sulcus, The laser
tip is cut at a 45
degree angle during the first pass. The laser is cut at the opposite 45 degree
angle during the second
pass. This allows for the laser beam to penetrate the existing periodontium to
decontaminate the
tissue, as the heat of the targeted laser light kills the bacteria.. This also
allows for biostimulation
of the sulcular contents, At block 20, the dentist scales the sulcular area
and root surfaces once
again to induce a healing response through renewed blood flow. Going to block
22, at least one
substrate, such as but not limited to matrix proteins, is then placed in the
sulcus of the tooth prior
to the blood clot terming and at block 24, a blood clot is carefiilly allowed
to form by gently
helping patient keep their mouth open for 5 minutes, to keep the substrate
intact. Optionally, the
laser light utilizes the IR wavelength range (700nm 1400nm.) at a laser power
of ,001 W to 5W
to treat wounds.
Alternatively, the laser tip is a specially designed tip that disperses light
energy throughout
the wounded stilcus which allows the laser beam to penetrate the existing
tissues to decontaminate
the tissue, as the heat of the targeted laser light kills the bacteria and as
a result block 20 may be
eliminated going directly to block 22
The LAPOR protocol is much less invasive than traditional surgery and offers
advantages
and benefits over its counterpart. Recovery time is much faster because most,
if not all, damage to
healthy tissue is avoided through the use of more advanced technology. Because
the LAPOR
protocol leaves healthy tissue intact, the height of the gums themselves
increases around the teeth
and is better preserved, The LAPOR protocol prevents long junctional
epithelium_ from migrating
downwards into the sulcus, thus preserving the tissue height and allowing for
the regeneration of
the periodontiten.
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Referring to Fig, 17a-17f, shown are various angles of the first embodiment of
a device
100 for use in conjunction with the substrates and methods of the present
invention. Fig. 18a and
18b show perspective .views of the device 100 in the first embodiment.
Specifically, Fig, 18a
illustrates an exploded view of the device 100 comprised of cord 101
integrally connected to
handle 109, handle 109 further connected to beat sink 102. Housing 103
securely connects to
heat sink 102 thereby creating a cavity between the housing 103 and heat sink
102. Laser 104 is
positioned within the cavity between housing 103 and heat sink 102. Male
connectors 105
connect RF source 108 to housing 103 wherein threaded inserts 106 cover the
connection
therebetween. Cap 107 is positioned over housing 103 and secures to handle
109. FIG 18c
shows a detailed view of heat sink 102, laser 104, housing 103 and male
connectors 105 in
relation to each other. In a preferred embodiment, the device 100 may have a
plurality of RF
sources 108 wherein a plurality is defined as at least two tips (i.e. dipole).
Housing 103 is
capable of movement such that RF source 108 may be adjusted 45' up or down
relative to the x-
axis for ease of use depending upon the location of the wound receiving
treatment.
The laser energy may have wavelength in the green wavelength range (520-570
mu), red
wavelength rainge (620-750 Jun), or yellow wavelength range (570-590 urn)
having a wattage of
0.001W to 5W. In a preferred embodiment, laser energy has a wattage of .001W
to 5W. The
wattage is in the range of 0.001W to 4W2 more preferred in the range of 0,003
to 3W, and most
preferred in the range of 0.005W to 2W, The RF energy may have a power of 10
watts or lower.
The carrier wave frequency may be in the range of 0,1MHz to 20MHz while the
non-sinusoidal
waveform may he in the range of 0 to 40 KHz or from 0 to 240liz. In a
preferred embodiment,
the carrier wave frequency is in the range of 0.2MHz to 10MHz, preferably
0,3MHz to 5MHz.
Optionally a 0.001W to 10W range RF energy, preferably a 0.001W to 3W range,
is utilized in
the hertz range of 40 Hz to 24 GHz. in a flirther alternative embodiment, the
RF wave is more
than one sine wave wherein the more than one demonstrates a harmonics pattern.
Optionally, the
non-sinusoidal waveform may be in the range of the above parameters in the
absence of a carrier
wave.
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Referring to Fig. 19a49g, shown are various angles of a second embodiment of a
device
200 for use in conjunction with the substrates and methods of the present
invention. Fig. 20a
shows a perspective view of the device 200 of the second embodiment.
Specifically. Fig, 20a
illustrates an exploded view of the device 200 comprised of wire grommet 201
integrally
connected to handle 209, handle 209 further comprised of heat sink 202.
Housing 203 securely
connects to heat sink 202 thereby creating a cavity between the housing 203
and heat sink 202.
Laser 204 is positioned within the cavity between housing 203 and heat sink
202. Male connectors
205 connect RF source 208 to housing 203 Wherein threaded inserts 206 cover
the connection there
between. Fig, 20b shows a detailed view of laser 204 and housing 203 in
relation to each other.
Referring to Fig. 21a-21c, shown is a third embodiment of a device 300 for use
in
conjunction with the substrates and methods of the present invention. Fig. 21a
Shows a perspective
view oldie device 300 of the second embodiment. Specifically. Fig, 21b
illustrates an exploded
view of the device 300 comprised of wire grommet 301 integrally connected to
housing 303,
housing 303 further comprised of heat sink 302. Housing $03 securely connects
to heat sink 302
thereby creating a cavity between the housing 303 and heat sink 302. Laser 304
is positioned
within the cavity between housing 303 and heat sink 302. Male connectors 305
connect RF source
308 to housing 303 wherein threaded inserts 306 cover the connection there
between. Fig. 21c
shows a detailed view of laser 304 and housing 303 in relation to each other.
By way of example
only, the device may have five or six. tips.
Referring to Fig. 22a and 22b, shown is a fiber optic device 400 for use in
conjunction with
the subsLates and methods of the present invention. Fiber optic device 400 is
comprised of hand
grip assembly 401 disposed between a first end and a second end. The first end
is further
comprised of nose insert 402 positioned between hand grip assembly 401 and
removable nose
a.sserribly 404. Bent fiber tube 405 extends from removable nose assembly 405.
The second end
is fin-tiler comprised of base insert 406 positioned between hand grip
assembly 401 and rubber
boot 407. Extending from rubber boot 407 is sheathed fiber 408 having a SMA
connector 409 at
the end opposite rubber boot 407. Fig, 22c shows a fully assembled fiber optic
device 400 further
comprising a body for housing the laser source.
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Firstly, the conditioner is applied to the root or bone surface. The root
conditioner
corn.prises the following at Table 1:
Table I
component
EDTA 20-25g.
calcium &cm-late 10-20 g.
Methylparaben 1-9g.
Pro pyl pa ra ben 01-1g..
Etha nola mine 2-8 oils.
Ca rboxymethylcellulose 240g.
Green food coloring 1-2 drops
Sterile water 100 tills.
The conditioner is optionally rinsed out prior to application of additional
substrates or laser
lightõAlternatively, the conditioner is left on the root or bone surface with
the laser light being
applied prior to application of any substrate. In an alternative embodiment,
the conditioner is left
in with only one substrate applied prior to application of the laser light
Optionally, the conditioner
is left in the sulcus and substrate is added prior to any application of laser
light.
The placement of the substrate into the sulcus containing luminesced blood
enables the
luminesced blood to coagulate upon the substrate.
Optionally, the liquid substrate or substrate I is comprised of the following,
per I., of
solution, at Table 2:
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Table 2
Essential
Amino Acids _______________
Isoleucine 1.125
Lend ne 1.125
Methionine 1.1.25
Phenylalanine 1.125
Threonine 1.125
Tryptophan 1.125
Vann e 1.125
Histidine 1.125
Lysine 9
Nan-
Essential
Amino A ads
Alanine 0.25
0.25
Aspartate 0.75
Glutamate 0.25
Glyeine 0.25
Serine 0.25
Prolific 9
.Phos&totes
ADP 0.667
ATP 0.667
Acetylcholine 0.667
Free Bases
Adenosine 1.725
Uridine 1.725
Guanosine 1.725
Cytidine 1.725
Benzoic Acid
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Sodium
1.1
Chloride
Sterile water 60
Total: 100
Optionally, the total sterile water component is adjusted 20% up or down,
depending on
the desired viscosity to be achieved.
In an alternative en-abodiment, the liquid substrate or substrate I is
comprised of the
following, at Table 3:
Table 3
Essential
Grains
Amino Acids ..........................
ist)k mine 11.25
Lamina 11.25
Methionine 11,25
Phenylalanine 112.5
Threonine
Tryptophan 11,25
\Wine 11.25
Histidine 11,25
Lysine 90
Non-
Essential Grams
Amino /icids
Arne 2.5
Arginine 2.5
Aspartate 7.5
Glutamate 2,5
Glycine 2.5
Serine 2,5
Praline 90
Phosphates Grams
ADP 7-8
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ATP 7-8
Acetylcholine 6-7
Free Bases Grams
Adenosine 13-14
'Uridine 1344
Guanosinc 13-14
Cytidine 13-14
Iridine 13-14
Benzoic Acid 20
Sodium
.1-S
Chloride
Sterile water
In an alternative embodiment, an additional substrate may be applied, the
additional
substrate, substrate 2, comprised of: tricalcium phosphate wherein the
tricalcium phosphate is
precipitated with calcium hydroxide/Claw oil; and hydroxyapatite crystals.
in an alternative embodiment, an additional substrate may be applied, the
additional
substrate, substrate 3, is comprised of the following at Table 4:
Table 4
200mg
Hyaiuronic acid
to 5.1g
Fatty odds Grams
Urccacki(L&) 4
Alpha-linolenic acid
4
(ALA)
8
Sugars (except
Grams
glucose and fame)
nnow 0.6
Galactose 0.6
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N-
0,6
acetylpiackosamine
N-
0,6
ace.tylglucosamine
N-acetylneurarninic
0.6
acid
Fucose (1 config.
and no carboxyl at 6 0.6
position)
Xyiose 0.6
4.2
Glucose 1,1
Fucose (L config.
and no carboxyl at 6 1,1
position)
Lipids Grams
A 03
D2 0.3
D3 0.3
0,3
Ki 0.3
K2 0.3
B12
0.3
(Methylcobalamin)
B12
0.3
(Nydroxocobalamin)
Cholesterol 0.3
Diaglycerol 0.3
3.0
Vitamins Grams
81 0.3
82 0.3
83 0.3
35 0.3
86 0,3
87 0.3
B9 0.3
0,3
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Pantothenic acid 0.3
2.7
Electrolyte Sources Grams
Calciuni chloride .5
Choline Chloride .5
Magnesium Suitate .5
Potassium Chloride .5
Potassium
Phosphate-
monobasic
Sodium Bicarbonate .5
Sodium Chloride .5
Sodium Iodide
4,5
Metals Grams
Ag nanoparticies 0.3
Au na no pa rticies 0.3
0.6
Iconic metals Grams
Copper 0.3
Zinc 0,3
Selenium 0.3
Iron 0.3
Manganese 0.3
Cobalt 0.3
Chromium 0.3
Boron 0.3
Molybdenum 0.3
2.7
Other lank rnet(2115 Grams
Boron 0,3
Silicon 0,3
Nickel 0.3
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Vanadium 0.3
1.2
Up to
Benzoic Acid
10,1
Sodium Chloride .1-.9
60-
Sterile water
300m1
Optionally, the total sterile water component is adjusted 20% up or down,
depending on the desired
viscosity to be achieved.
In an alternative embodiment, an additional substrate may be applied, the
additional
substrate, substrate 4, is comprised of the following at Table 5:
Tablc 5
Component Grams Notes
carbomer 10-40 For acute wound (see Fig. 39} use 10-20
For chronic wound (see Hg. 38) use 25-40
Electrolytes Grams
Potassium chloride 0.5-3
Chloride 01,1-1
Sodium 0,1-1
Potassium 0.14
Manganese 0.1-1
With one size or variety of sizes of crystals: 4-50
Calcium tri- 0 gm, 50-150 pm, 100-300 gm, 500-1000 m, 1-3
.5-4
Phosphate mm, and 3-6 mm; may be dense or porous.
Sulfate 0.14
Bicarbonate 0.1-1
50-150 ml; for chronic wounds substrate 6 may be
Snail serum incorporated (see Fig. 41); decreases depending
of
volume of substrate 6
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SW secretion SO-
filtrate 150mg
HA 3-6
Au 0.14
Ag 0,1-1
Cu 0,1-1
Fe 01-1
Pt al-1
SO-
Collagen
150
fucose as-1
Oyceine KC 0-0A,
Metals may be increased 50% for chronic wounds (see Figõ 40).
Optionally, the total sterile water component is adjusted 20% up or down,
depending on
the desired viscosity to be achieved.
Substrates 1, 2 and 3 may have different modalities of delivery, for example,
drops, sprays,
injections or intravenous having the same ingredients, as well as sublingual,
anal, foam and
ointment formulations or drinkable liquids.
In an alternative embodiment, an additional substrate may be applied, the
additional
substrate 5 is comprised of the following:
1. collagen, limed and/or
2. collagen, u.nlimed, and/or
3. collagen, supplemented with porous tricaleiwn phosphate crystals with
one size or
variety of sizes: 4-50 gin, 50-150 pm, 100-300 gm, 500-1000 gm, 1-3mm and 3-6
mill The
tricalcium phosphate crystals may be dense or porous. Optionally, substrate 5
may be used in the
absence of other substrates.
In an alternative embodiment, an additional substrate may be applied, the
additional
substrate 6 is comprised of the following:
I. collagen, limed and/or
2. collagen, until/led and/or
õ HCi and/or
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4, NaCI and/or
5. Cu, Ag, Fe, Au, Pt or any combination thereof and/ox
6. Collagen, supplemented with. porous tricalcium phosphate crystals with
one size or
variety of sizes: 4-50 pm, 50450 lum, 100-300 pm, 500-1000 m, 1-3mm and 3-6mm.
The
tricalcium phosphate crystals may be dense or porous. Optionally, substrate 6
may he used in the
absence of other substrates.
An additional substrate may be applied, the additional substrate comprised of
the
following: a mixture of tricalcium phosphate and hydroxyapatite crystals. The
tricalcium
phosphate is precipitated with CaOH/devil's claw oil, in a preferred
embodiment Optionally, the
additional substrate includes 50% tricalcium phosphate/devil's claw oil
precipitated with 50%
porous hydroxyapatite crystals. The tricalcium phosphate crystals used are
granules in the
following sizes: 4-50 pm, 50-150 pm, 100-300 p.m, 500-1000 gm, 1-31mn and 3-6
ram. The
tricalcium phosphate crystals may be dense or porous.
The additional substrate may be comprised of hydroxyapatite crystals of
granules
containing the following sizes: 10-50 um, 50-150 pm, 100-300 um, 500-1000 pm,
1-3min and 3-
6 nun. The hydroxyapatite eryskals may be dense or porous.
In the following examples, the conditioner is applied and subsequently rinsed
out.
Optionally, the conditioner is left in the suleus, as the conditioner allowed
the mien-Toms within
the tooth structures to remain open.
After the conditioner is applied, the sulcus is biestimulated with a laser
light. After this
occurs, the liquid substrate is applied. Optionally, the additional substrate
is applied. For cavities
other than oral cavities, a diluted substrate assists treatment when ingested
or taken via IV is
beneficial although not required.
In an alternative embodiment, an optional spray substrate, spray I, may be
applied, the
spray comprised of the following: Au, Ag, Cu, Fe, Pt, and sterile water.
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In an alternative embodiment, an optional spray substrate, spray 2, may be
applied, the
spray comprised of the following: Cl, Na, K, Mg, Phosphate, Sulfate,
bicarbonate and sterile water.
The fiber optic device of the present invention is the sole device placed
inside the sulcus
for treatment. The suleus may also be treated with lager, RP or laser with RR
The remaining
disclosed embodiments of the device may be used in wound treatment in
conjunction with the
substrates depending on the wound site and sevet-ity of the wound. Substrates
disclosed herein
may be a form including, but not limited to, liquid, tablet, enema, gel,
injection or foam.
Alternative RF andlodaser assisted wounded tissue rmszneration:
1. Seale/root plane;
2. Etch root of tooth;
3. Rinse with saline water;
4. Place tip of laser into the sulcular wound and turn the laser on for 5
seconds;
5. Repeat step 4 circumferentially vertically and horizontally around tooth
until the
entire sulcular wound has been saturated by laser energy;
6. Place Substrate 1, and/or 2, and/or 3, and/or 4 and/or 5 into glass
dappen dishes;
7. Mix the desired amount of substrate 1, and/or 2 and/or 3 and/or 4 and/or
5 in dapper,
dish;
8. Place the desired mixture into the sulcular wound where bone/tissue loss
()CCM-1W;
9. Wait a fogy seconds;
10. Place more of the mixture into the sulcular wound where boneltissue
damage
occurred;
11. Wait a few seconds:
12. Repeat steps 8 until all defects have been filled;
11 Wait 1 minute;
14. Place hand piece with its RF tip and/or LED tip, with or without laser,
perpendicular
to the wound, turn on and keep in position for / minute;
15. Wait 10 seconds; and
16. Repeat RF step 14 until entire wound has been covered with RF energy,
with or
without laser.
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Alternative flIz and/or imser assisted Weunded tissue repair:
1. Cleanse wound with saline;
2. Place Substrate 1 and/or 3 onto wound;
3. Direct .RF/laser, RF, LED, or laser energy at wound for 1 minute;
4. Place another layer of substrate 1, and/or 2, and/or 3, and/or 4, and/or
5 or any
combination thereof onto wound;
5. Wait 10 seconds;
6. Repeat steps 2-5 until wound bed is covered; and
7. Alternatively wait a week in between step 2-6 and gradually cover wound
bed.
Treatment of the oral cavity, headineck, tongue, anal, vaginal region and the
deeper areas
reached while treating these may be performed with the RF with substrate
(applied substrate or
drank with water), RF without substrate, RF plus laser with substrate (applied
substrate or drank
with water.). RF plus laser without substrate and laser with substrate
(applied substrate or drank
with water), laser without substrate. The treatment described may be utilized
throughout the
gastrointestinal tract, hea.dinock and anus. 'The laser, RF or LED treatment
applied to the oral
cavity and surrounding structures, anal cavity and its surrounding structures,
head and neck region
and its surrounding structures has benefits in deeper areas of the structures.
Those deeper areas of
the corresponding structures are thus part of the treatrnerit site.
Surrounding structures include,
but are not limited to, all bone, cartilage, muscles, tendons, nerves, blood
vessels, epithelium and
fascia.
andler laser assisted head and neck wound tissue repair:
1. Drink 4 oz. diluted Substrate 1;
2, Wait 15 minutes;
3. Drink 4 oz. diluted Substrate 3;
4. Wait 15 minutes;
5. Direct RFilaser, RF or laser energy at head and neck location and the
surrounding
structures where wound occurred;
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6. Keep energy in place or move over desired area until desired effect
achieved; and
7. Move on to nest site until desired result achieved,
Surrounding structures include, but are not limited to, all bone, cartilage,
muscles, tendons, nerves,
blood vessels, and epithelium.
Head and neck includes, but is not limited to, all structures of the head and
neck including
esophagus and its surrounding structures, mouth including all interior mouth
structures such as
tongue (entire area of tongue including but not limited .to anterior,
posterior, dorsal, ventral, and
sublingual), floor of mouth including but not limited to arterial and nerve
beds, lines alba,. buccal
M1100Sa, buccal flanges, lingual flanges, nose, interior of nose (including
but not limited to the
epithelial lining), all muscles and other structures of the tongue and
surrounding the tongue, all
muscles of the eye and surrounding the eye, all arterial, venous and nerve
beds of the eye and
surrounding the eye. All muscles, nerves, veins, all glands and tissue of the
head and neck and.
any other structure of the head and neck,
RF and/or laser assisted vaginal wound repair:
1. Drink 4 oz. diluted Substrate 1;
2. Wait 15 minutes;
3, Drink 4 oz. diluted Substrate 2;
4, Wait 15 minutes;
5. Direct RF/laser, RF or laser energy at the vagina and its surrounding
structures;
6. Keep energy in place for i 0-20 minutes or until desired effect
achieved;
7. Rotate hand piece; and
8. Repeat steps 5-7 until desired result achieved.
Surrounding structures include, but are not limited to, all bone, cartilage,
muscles, tendons, nerves,
blood vessels, and epithelium.
RF and/or laser and/or LED assisted wound/tissue rep* ¨ sphincter ard
exterids:
1. Drink 4 oz. diluted Substrate 1, and/or 2, and/or 3, and/or 4, and/or 5;
2. Wait 15 minutes;
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3. Drink 4 oz, diluted Substrate 1, and/or 2, and/or 3, and/or 4, and/or 5;
4. Wait 15 minutes;
5. Direct RF/laser, RLF or laser energy at the anus and its surrounding
structures;
6. Keep energy in place for 10-20 minutes or until desired effect achieved;
7. Rotate hand piece; and
8. Repeat steps 5-7 until desired result achieved.
Surrounding structures include, but are not limited to, all bone, cartilage,
muscles, tendons, nerves,
blood vessels, and epithelium and any other structures of the anal cavity.
andlor laser assisted Wailitid repfiritissue repair - breast:
I. Drink 4 oz. diluted Substrate 1, and/or 2, and/or 3, and/or 4,
and/or 5;
2, Wait 15 minutes;
3. Drink 4 oz. diluted Substrate /, and/or 2, and/or 3, and/or 4, and/or 5;
4. Wait 15 minutes;
5. Direct RFilaser, R,F or laser energy at the breast and structures
related to the breast;
6. Keep energy in place for 10-20 minutes or until desired effect achieved;
7. Rotate hand piece; and
S. Repeat steps 5-7 until desired result achieved,
Related structures include, but are not limited to, all bone, cartilage,
muscles, tendons, nerves,
blood vessels, lymph nodes and epithelium.
RF audiur laser assisted
d/tissue reDafr4 d its supporiresinthe
mechanism:
1. Drink 4 oz. diluted Substrate 1, and/or 2, and/or 3, and/or 4, and/or 5;
2. Wait 15 minutes;
3. Drink 4 oz. diluted Substrate 1, and/or 2, and/or 3, and/or 4, and/or 5;
4. Wait 15 minutes;
5. Direct RFIlaser, RF or laser energy at tongue and its surrounding
structures;
6. Keep energy in place for 10-20 minutes or until desired effect achieved;
7. Rotate hand piece if necessary; and
8. Repeat steps 5-7 until desired result achieved,
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Surrounding ,structures include, but are not limited to, all bone, cartilage,
muscles, tendons, nerves,
blood vessels, and epithelium.
RF and/or laser assisted. wooed rmuncratiow
1. Drink 4 oz. diluted Substrate I, and/or 2, and/or 3 andlor 4, and/or 5
and/or 6;
2. Wait 15 minutes;
3. Drink 4 oz. diluted Substrate 1, and/or 2, and/or 3, and/or 4, and/or 5
and/or 6;
4. Wait 15 minutes;
5, Direct RE/laser, RF, LED or laser energy at wound and its
surrounding struetums;
6. Apply Substrate 1, and/or 2, and/or 3, and/or 4, and/or 5 and/or 6;
7. Direct RE/laser, RF, LED or laser energy at wound and its surrounding
structures;
8. Keep energy in place for 10-20 minutes or until desired effect achieved;
9. Rotate energy source if necessary; and
10. Repeat steps 5-9 until desired result achieved.
11 Alternatively wait a week in between steps 5-9 and gradually cover
wound bed.
Surrounding structures include, but are not limited to, all hone, cartilage,
muscles, tendons, nerves,
blood vessels, and epithelium.
RF and/or laser assisted Dore repair:
1. Drink 4 oz. diluted Substrate 1, and/or 2, and/or 3, and/or 4,
and/or 5;
2, Wait 15 minutes;
3. Drink 4 oz. diluted Substrate 1, andlor 2, and/or 3, and/or 4, and/or 5;
4. Wait 15 minutes;
5. Direct RF/laser, RF or laser energy at pores and their surrounding
structures;
6. Keep energy in place for 10-20 minutes or until desired effect achieved;
7. Rotate hand piece; and.
8. Repeat steps 5-7 until desired result achieved.
Surrounding structures include, but are not limited to, all bone, cartilage,
muscles, tendons, nerves,
blood vessels, and epithelium.
RF andior laser and/or LED assisted oral cavity wound repair:
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1. Drink 402. diluted Substrate 1, andlor 2, and/or 3, and/or 4, and/or 5
and/or 6;
2, Wait 15 minutes;
3. Drink 4 oz. diluted Substrate 1, and/or 2, and/or 3, and/or 4, and/or 5
and/or 6;
4, Wait 15 minutes;
5. Direct RE/laser, RF or laser energy at oral cavity and its' surrounding
structures;
6, Apply Substrate 1, and/or 2, and/or 3õ and/or 4, and/or 5 and/or 6;
7. Direct RE/laser, RF, LED or laser energy wound and its surrounding
structures;
8. Keep energy in place for 10-20 minutes or until desired effect achieved;
9. Rotate energy source; and
8. Repeat steps 5-9 until desired result achieved.
Surrounding structures include, but are not limited to, all bone, cartilage,
muscles, tendons, nerves,
blood vessels, and epithelium.
Further still, wound treatment may be utilized for additional conditions
including, but not
limited to, vaginal wound repair, breast wound repair/regeneration/generation,
anal wound repair,
age spot repair, pore repair, skin and tissue repair and general body wound
repair.
Referring to Fig 33a-33e, shown is a fourth embodiment of a device 500 for use
in
conjunction with the substrates and methods of the present invention. Fig. 33a
shows a top view
of the device 500 of the fourth embodiment. Fig. 33h shows a side view and
Fig. 33c shows a
close-up of the tip of device 500. Specifically', Fig. 33d illustrates an
exploded view of the device
500 comprised of housing 503, tips 505 and energy source 507. Energy source
507 provides RF
energy to housing 503 when connected. Fig. 33e shows a side perspective view
of the assembled
device 500. Optionally, the device 500 may be used in the absence of
substrates.
Referring to Fig. 34a-34f, shown is a fifth embodiment of a device 600 for use
in
conjunction with the substrates and methods of the present invention. Fig. 34d
and 34f show side
perspective views of device 600. Fig. 34a shows a side view of device 600
wherein device 600
has a hemispheric shape and is further comprised of a flat surface opposite
the hemispheric surface.
The flat surface is fur her comprised of a plurality of mini lasers 605 for
delivery of diode laser
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energy for treatment of an acute wound. The mini lasers 605 are self-contained
within device 600,
In a preferred embodiment, the laser power used for treatment may be
fipproximaely 6-24 niVir.
Referring to Fig. 35a-35f, shown is power device 700 for a fiber optic had
piece for use in
conjunction with the substrates and methods of the present invention. Fig. 35a
shows the
components of pocket power device 700, the pocket power device 700 further
comprised of a base
701, a battery mount 702, a rechargeable battery 703, a handle for a fiber
optic laser 704, and a top
705. Fig. 35b-35f show various views of the pocket power device 700. The
handle 704 is a self-
contained unit having an attached fiber optic line 706 upon which a fiber
optic laser head (not
shown) is connected. Further, a diode laser module is housed in pocket power
device 700.
Referring to Fig. 36a-36f, shown is a portable RE transmitter 800 for use in
conjunction
with the substrates and methods of the present invention. Fig, 36e and 36f
show side perspective
views of RE transmitter 800. Fig. 36a shows a top view; Fig. 36b shows front
view; Fig. 36c
shows a bottom view; and Fig, 36d shows a left side view. Optionally, the RF
transmitter 800 may
be used in the absence of substrates.
Referring to Fig, 37a-37b, shown are alternative embodiments of
interchangeable fiber
optic tips for a laser for use in conjunction with the substrates and methods
of the present invention.
Fig. 37a shows an interchangeable fiber optic tip for a laser having a nose
piece 900 and a flat tip
901. Fig. 371, shows an interchangeable fiber optic tip for a laser having a
nose piece 900 and a
glass dispersion tip 902.
Examples
An,thadõs,..91õTheittmAL.11,un4clue,,Loo
A patient's pocket depths at tooth 15 were measured at 12 separate loci, The
root of the
tooth was then scaled and planed to remove calculus build up on the root
surface, After scaling
and planning, bleeding occurs in the sulcus. The sulcus was allowed to air
dity and immediately
thereafter the conditioner is applied to the sulcus and left for 30 seconds
before being rinsed with
saline, The tooth was next scaled and planed again to renew blood flow, With
blood pooling in
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the sulcus, the 45 laser tip was placed into the sulcus. The laser light used
has a wavelength in the
visible portion of the electromagnetic spectrum, between 400nm ¨ 700mn
wavelength. The la...g.tr
was emitted continuously with only intermittent stops for tissue temperature
control. The laser
was allowed to penetrate the entire sulcus by moving the tip vertically and
horizontally throughout
the sul ells for 10 second. The :Ina' tip was cut to 45" in the opposite angle
for the second pass into
the sulcus and 90' for the third pass to allow the laser bean to penetrate the
existing periodontium
to decontaminate and biostimulate the sulcular contents.
In the meantime, the first substrate and the second substrate were mixed in a
glass dish.
Some of the patient's blood that has been treated with the laser light in the
sulcus was also mixed
in the glass dish. This mixture is then placed immediately into the sulcus
upon mixture. Enough
of the mixture was placed into the sulcus to fill the sulcus while ensuring
the mixture stayed 3 aim
below the top of the gingival margin and remained immersed in blood. The
patient's mouth was
kept open for 5 minutes to ensure the newly formed blood clot containing the
substrate mixture
remained intact.
Treatment was repeated on tooth 15 on four subsequent occasions, at which time
the pocket
depths at each loci were measured prior to treatment Measurements are shown in
Fig, 11, The
data show an increase in calcium density at the specific. loci.
IL Analysts of Tooth #12 at 17 Unique Loci
A patient's pocket depths at tooth 28 were measured at /7 separate loci. The
treatment
disclosed herein was performed on five subsequent occasions, at which time the
pocket depths at
each loci were measured prior to treatment. Measurements are shown in Fig. 12.
The data show
an increase in calcium density across all loci.
ILL Analysis of Tooth #2. #3 and #15 at 3 Unique Lod Per Tooth.
A patient's pocket depths at tooth 2., tooth 3 and tooth 15 were measured at
three separate
loci per tooth. The treatment disclosed herein was performed 3 months after
the initial treatment,
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at which time the pocket depths at each loci were measured prior to treatment.
Measurements are
shown in Fig. 13. The data show a progression of bone generation.
A.natsis of Chin Profile
A patient's chin profile was measured, The treatment disclosed herein was
performed
once after the initial measurements were taken with measurements repeated
following treatment.
Measurements are shown in Fig. 24. The data show a general increase in chin
profile fellowing
a single treatment.
V. Analysis of Toe Crease
A patient's toe crease length was measured. The treatment disclosed herein was
performed after initial measurements were obtained with measurements repeated
following
treatment Measurements are shown in Fig. 25. The data show a 71% overall
decrease in crease
size following treatment.
YL Analysis of Gingivsd Wound. Tissue
A patient's gingival wounds were measured from the line to the top of the
gingiva. The
treatment diselooed herein was performed and measereramts ware repeated
following treatment.
Images of gingival wounds are shown before and after treatment in Fig. 26a and
26h.
Measurements are shown in Fig. 26e. The data show a 50% or greater decrease in
the wound
following a single treatment.
VII. Analysis of Hand Crease
A patient's hand crease length was measured. The treatment disclosed herein
was
performed after initial measurements were taken with measurements repeated
following
treatment. Measurements are shown in Fig, 27, The data show an overall
decrease in crease
length .following treatment.
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ABIANSIS of New Skin Growth
A patient's skin leg wound was measured. The treatment disclosed herein was
pertbrrned
after initial measurements were taken with measurements repeated. following
treatment.
Measurements are shown in Fig. 28. The data show an overall increase in new
skin growth
following treatment. In a preferred embodiment, chronic wounds on limbs may be
treated using
a three-sided LED system wherein the treatment unit is placed around the limb
on three sides and
applies the LED energy to a larger surface area. The LED system uses an energy
source no
greater than 60 MW.
IX. linallsis of Anal Sear Reduction
A patient's anal scar tissue was measured. The treatment disclosed herein was
performed
after initial measurements were taken with measurements repeated following
treatment
Measurements are shown in Fig. 29 and Fig. 30. The data show a reduction in
both length and
width of sear tissue following treatment.
X. Analysis of Tongue Strenkth
Tongue strength and swallowing was assessed for three patients. The treatment
disclosed
herein was performed after initial assessments were made and tongue strength
and swallowing
were reevaluated following treatment. Measurements are shown in Fig. 31, The
data show each
patient experiencing an increase in tongue strength following treatment.
XL Analysis of Breast Firmness
Breast firmness was recorded for two patients. The treatment disclosed herein
was
performed after initial assessments were made and breast firmness was
reevaluated following
treatment. Comparative firmness is shown in Fig. 32. The data show the
patients experiencing
an increase in firmness of 75% and 66.7% following treatment, respectively.
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XII. Analysba of Epithelisd Wound Regeneration
The epithelial wound regeneration of a patient was assessed. The treatment
disclosed
herein was performed after initial wound measurement and wound size was
remeasured
following treatment. Comparative measurements are shown in Fig. 38, Epithelial
regeneration
was found to have increased in area by 170% one day following treatment,
XIIL.Analvsis of Cale tlea.1 Tendon Wound Regeneration
The calcaneal tendon wound regeneration of a patient was assessed, The
treatment
disclosed herein was performed after initial wound measurement and wound size
was
remeasured following treatment. Comparative measurements are shown in Fig. 39,
Tendon
Shelf size increased four times from the initial measurement to the third and
final measurement,
XIII. Analysis of Ankle Epithelial Wound Regeneration
The ankle epithelial WOUIld regeneration of a patient was assessed. The
treatment
disclosed herein was performed after initial wound measurement and wound size
was
remeasured following treatment Comparative measurements for two treatment
areas are shown
irt Fig. 411 Epithelial regeneration was found to have increased in area by
264% five months
following treatment.
XIV. Analysis of Ankle Wound Size Reduction
The ankle epithelial wound size reduction of a patient was assessed. The
treatment
disclosed herein was performed after initial wound measurement and wound size
was
remeasured following treatment, Comparative measurements for two treatment
areas are shown
in Fig, 41, Epithelial wound size was found to have decreased in area by 72%
five months
following treatment.
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XV. Linatvsis of Oral Cavity Wound Reeeneration
The oral cavity epithelial wound regeneration of a patient was assessed. The
treatment
disclosed herein was performed after initial wound measurement and wound size
was
remeasured following treatment. Comparative measurements are shown in Fig. 42.
Epithelial
regeneration size increased by 1.34 cm2 from the initial measurement to the
fourth and final
measurement.
XVI. Analysis of Vein Wound,
The vein wound regeneration of a patient was assessed. The treatment disclosed
herein
was performed after initial wound measurement and wound RiZe was remeasured
following
teatment. Comparative measurements are shown in Fig, 43a. Epithelial
regeneration size
increased by 2.9 cm2 from the initial measurement to final measurement.
Treatment was
conducted using a flashlight style infrared laser as shown in Fig, 43b wherein
the LED beam is a
concentrated flat line of light applied to the skin and veins. The flashlight
style laser is a self-
contained modular laser that allows for manipulation of skin around a wound
during treatment.
Althrnatively, a. LED paid way be used,
One embodiment of the present invention provides a device for treating a wound
according to the method described herein, the device emitting a laser a beam
of light having a
wavelength in the green wavelength range (520-570 ma), red wavelength range
(620-750 mil), or
yellow wavelength range (570-590 urn) having an alternative wattage of 0.001W
to 5W,
preferably 0.002W to 4W, more preferably 0.003W to 3W, and most preferably
0.005W to 2W.
Optionally, the laser light utilizes the IR wavelength range (700mn ¨ 1400nm)
at a laser power
of ,001W to 5W to treat wounds. Optionally, a LED light utilizes the IR
wavelength range to
treat wounds.
Another embodiment of the present invention provides a device for treating a
wound
according to the method described herein, the device emitting a RF beam .up to
lOW comprised
of a carrier wave frequency in the range of 0_1MHZ to 20MHz and a non-
sinusoidal waveform in
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the range of 0 to 40 KHz. In a preferred embodiment, the carrier wave
frequency is in the range
of 0.2MHz to 10MHz, preferably 0,31Vatz to 5MHz. Optionally a 0.001W to lOW
range RF
energy, preferably a 0.001W to 3W range, is utilized in the hertz range of 40
Hz to 24 GHz, In a
further alternative embodiment, the RF wave is more than one sine wave wherein
the more than
one demonstrates a harmonics pattern. Optionally, the non-sinusoidal waveform
may be in the
range of the above parameters in the absence of a carrier wave.
Yet another embodiment of the present invention provides a device for
treatment of a
wound according to the method described herein, the device, emitting a laser
beam, a RF beam or
a ombination. thereof.
Still another embodiment of the present invention provides a device for
treatment of
wounds in the oral cavity according to the method described herein, the device
emitting a fiber
optic laser beam. In a preferred embodiment, the fiber optic device may be
used in conjunction
with the laser and RF device for treating general wounds and wounds of the
oral cavity.
Optionally, the device emits a LED light.
Whi1C there have been shown and described and pointed out the fundamental
novel features
of the invention as applied to the preferred embodiments, it will be
understood that the foregoing
is considered as illustrative only of the principles of the invention and not
intended to be exhaustive
or to limit the invention to the precise forms disclosed.
Obvious modifications or variations are possible considering the above
teachings. The
embodiments discussed were chosen and described to provide the best
illustration of the principles
of the invention and its practical application to enable one of ordinary skill
in the art to utilize the
invention in various embodiments and with various modifications as are suited
to the particular
use contemplated All such modifications and variations are within the scope of
the invention as
determined by the appended claims when interpreted in accordance with the
breadth to which they
are entitled.
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