throbber

`
`US 20050228463A1
`
`(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2005/0228463 A1
`
`
` Mac et al. (43) Pub. Date: Oct. 13, 2005
`
`(54) METHOD AND APPARATUS FOR TREATING
`THE BODY
`
`(52) us. Cl.
`
`.............................................................. .. 607/89
`
`(76)
`
`Inventors: Bia Mac, San Jose, CA (US); John
`Iest, R. Santa Margarita, CA (US);
`Theresa Quach, San Jose, CA (US)
`
`Correspondence Address:
`SHOEMAKER AND MATTARE, LTD
`10 POST OFFICE ROAD - SUITE 110
`
`SILVER SPRING, MD 20910 (US)
`
`(21) Appl. No.:
`
`10/814,785
`
`(22)
`
`Filed:
`
`Apr. 1, 2004
`
`Publication Classification
`
`(51)
`
`Int. Cl.7 ..................................................... .. A61B 5/06
`
`(57)
`
`ABSTRACT
`
`A therapeutic method in which plural points on the body are
`stimulated by light of different wavelengths emitted from
`wands, probes or other applicators under the control of a
`central microprocessor. The microprocessor executes pro-
`gram instructions to produce light at each applicator whose
`intensity, frequency, duration and pulsation accord with
`protocols which are automatically selected depending on the
`portion of the body being treated. The protocols can be
`manually overridden by the therapist,
`in which case the
`changed parameters are stored in memory. The apparatus is
`particularly useful
`in performing traditional
`therapeutic
`methods to treat internal disorders, substance abuse, pedi-
`atric and podiatric problems and disorders of the ear, nose,
`throat, as well as musculoskeletal, neurological or derma-
`tological disorders.
`
`Data from Cell
`8; Tissue Culture
`
`
`
`
`Data from
`
`Animal Study
`
`
`
`
`
`
`
`
`Recovery
`Mechanism
`
`Data from
`Human
`
`
`
`
`
`
`
`% Tissue Optic,
`Optimal
`wavelength,frequency,
`Light«Tissue Interact
`
`
`lntensity, Dosage
`
`
`
`
`
`
`Treatment
`
`
`Protocols
`
`
`
`
`
`Control Clinical Trial
`BELG Method &
`
`
`
`Data
`
`
`
`Computerized —
`Devices
`
`
`
`Multiple
`Pilot Treatment
`
`
`Treatment
`
`
`Center
`Centers
`
`
`
`
`
`0001
`
`US. Patent No. 8,652,040
`
`Apple Inc.
`APL1065
`
`Apple Inc.
`APL1065
`U.S. Patent No. 8,652,040
`
`0001
`
`

`

`Patent Application Publication Oct. 13, 2005 Sheet 1 of 10
`
`US 2005/0228463 A1
`
`Data from Cell
`
`8: Tissue Culture
`
`Data from
`
`Animal Study
`
`Recovery
`Mechanism
`
`Human
`
`
`
`
`% Tissue Optic,
`Optimal
`Light-Tissue Interact
`wavelengthfrequency,
`
`
`
`Intensity, Dosage
`
`
`
`
` Treatment
`Protocols
`
`
`
`Control Clinical Trial
`
`
`BELG Method &
`Data
`
`Computerized —
`
`Devices
`
`
`
`Multiple
`
`
`Pilot Treatment
`
`Treatment
`
`
`
`Center
`
`
`
`Centers
`
`Fig. 1
`
`0002
`
`0002
`
`

`

`Patent Application Publication Oct. 13, 2005 Sheet 2 0f 10
`
`US 2005/0228463 A1
`
`
`
`
`
`Fig. 2
`
`0003
`
`0003
`
`

`

`Patent Application Publication Oct. 13, 2005 Sheet 3 0f 10
`
`US 2005/0228463 A1
`
`
`
`
`
`
`
`
`
`
`Fig. 3
`
`0004
`
`0004
`
`

`

`Patent Application Publication Oct. 13, 2005 Sheet 4 0f 10
`
`US 2005/0228463 A1
`
`24
`
`24d
`
`
`
`26d
`
`26c:
`
`24b mm—
`
`26b
`
`28
`
`28c
`
`
`
`Fig. 4
`
`0005
`
`0005
`
`

`

`Patent Application Publication Oct. 13, 2005 Sheet 5 0f 10
`
`US 2005/0228463 Al
`
`28f
`
`F“
`
`
`
`Fig. 5
`
`0006
`
`0006
`
`

`

`Patent Application Publication Oct. 13, 2005 Sheet 6 0f 10
`
`US 2005/0228463 A1
`
`
`
`Incidau inlauilyaxmfacg = [00%
`
`.
`____11Wd.€”h"3_6%
`
`__ _ __ _?§!xménudondqwh==LT%
`
`l
`
`2
`
`3
`
`. Penetration deplh
`
`_ _ _ _3
`
`=4_S%
`
`100
`
`Ea?
`E'3

`.5
`3 50
`A:
`‘z
`
`‘5’
`E3
`
`Fig. 6a
`
`0007
`
`0007
`
`

`

`Patent Application Publication Oct. 13, 2005 Sheet 7 0f 10
`
`US 2005/0228463 A1
`
`100
`
`Melanin
`
`.9 ’0
`
`\
`
`_
`
`E“
`53
`Q
`Q:
`0)
`
`£3.
`E;
`No
`
`0‘5
`
`a
`
`I
`
`Water
`
`0.1
`
`0.01
`
`H6
`
`V
`
`-‘ Water
`
`HMOIygeRaIed)
`
`200
`
`300
`
`500
`Wavelength (mu)
`
`1000
`
`200
`
`Fig. 6b
`
`0008
`
`0008
`
`

`

`Patent Application Publication Oct. 13, 2005 Sheet 8 0f 10
`
`US 2005/0228463 A1
`
`SmES
`
`{avm
`
`8m.22,
`
`{at
`
`.oom~20...
`
`«owe
`
`agmzzggm
`
`
`
`83.8253E;332::£223$33::50
`
`858.oz
`
`e\ov
`
`3mErma
`
`£3302
`
`{on
`
`.81Erma
`
`{of
`
`
`
`,322:328Egan‘mlfifiamhsas:
`
`..
`
`327323.53
`
`238oz
`
`.$8
`
`
`
`03e.,2.x.231
`
`$32.35.”:
`
`335.25
`
`2.32oz
`
`{om
`
`.SmEcma
`
`{in
`
`£3302
`
`0%
`
`
`
`.0;.28.
`
`$00
`
`a::32£6.H.
`
`
`
`333.02352.18
`
`
`
`$0..8»
`
`I;
`
`.L:
`
`0009
`
`0009
`
`
`
`
`
`
`
`
`

`

`Patent Application Publication Oct. 13, 2005 Sheet 9 0f 10
`
`US 2005/0228463 A1
`
`
`
`385:3;:26
`
`32322232
`
`$3
`
`8m:28
`
`$9
`
`8m52.
`
`$2
`
`5:32.0588E32.829:3me
`
`30825285
`
`m:3mm_OZ
`
`Sgflfizflum
`
`322.525
`
`253.oz
`
`$08a653
`
`$8
`
`23%:02
`
`{K
`
`8mREE
`
`{Km
`
`
`
`883:2.5:382:3£2.23
`
`253.oz
`
`.égm5:3
`
`Qua_.
`
`0010
`
`253.oz
`
`$9
`
`8m5E3
`
`{own
`
`23802
`
`
`
`fin‘$8i8m$5
`
`.03;E6.”
`
`{emu
`
`.8m58
`
`$2
`
`0010
`
`
`
`
`
`
`
`

`

`Patent Application Publication Oct. 13, 2005 Sheet 10 0f 10
`
`US 2005/0228463 A1
`
`8m53
`
`.
`my.
`,9.
`
`
`
`852:3.M
`
`in.o&EB
`
`«a:
`
`
`
`23$.oz.omm5:th
`
`05mm
`
`{or
`
`mg:mm:02
`
`33:3;2:G2:;2:35:22.38wocx.ocozacflumou>nnamsmo£92.00
`
`:5.EE
`
`
`
`
`
`.332.3.8.2:E322:52:3
`
`.omEmEE
`
`$8
`
`gamma02
`
`35:3:558203Egg
`
`.94.0momm:.H
`
`ago
`
`.08Efmmmgzmm.oz
`
`£1.F0\00
`
`as:ammo£3
`
`$3
`
`
`
`.09“.3E».«on
`
`938..oz
`
`€35
`
`
`
`£339.onFunmaso2:3.695...
`
`6%58.
`
`{com
`
`60¢.38
`
`$3
`
`o\omm
`
`.ommErma.Qm0
`
`$.32oz
`
`
`
`833«6.25::«5.5.3
`
`.03“.Each
`
`$3
`
`0011
`
`0011
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`US 2005/0228463 A1
`
`Oct. 13, 2005
`
`METHOD AND APPARATUS FOR TREATING THE
`BODY
`
`BACKGROUND OF THE INVENTION
`
`[0001] This invention relates to a method and apparatus
`for treating the body.
`
`[0002] The apparatus of the invention uses low-intensity
`light
`to treat disorders of biological
`tissues, and more
`practically, provides a computer-controlled system including
`self-adhesive multiple probes and wands for applying bio-
`energy to the body. The invention also relates to methods of
`using low-intensity light for medical therapy, combining key
`principles from different areas of medicine.
`
`[0003] Since the time of “the father of western medicine,”
`Hippocrates,
`light and energy have been used to treat
`biological problems. More recently, N.R Finsen, “the father
`of contemporary photo-therapy”, used red and ultraviolet to
`treat lupus vulgaris, pockmarks, and other skin diseases.
`However, ultraviolet must be used with caution, because it
`is an ionizing radiation that has the potential for damaging
`biomolecules.
`
`[0004] Today, light sources are used in both the visible and
`the near infrared (and thus invisible) portion of the electro-
`magnetic spectrum to provide medical therapy. Such light
`sources provide both coherent and polarization modes (e.g.,
`laser diodes) and non-coherent modes (e.g., super luminous
`diodes).
`
`[0005] As reported by Karu in “Photo-biological Funda-
`mentals of Low Power Laser Therapy”, IEEE Journal Quan-
`tum Electronics QE-23, 10:1703-1987, photo-biological and
`clinically significant reaction responses of cells have been
`induced by non-coherent, non-polarized, monochromatic
`light. Laser beams penetrate deeper into the tissue, scattering
`quickly and losing the coherence and polarization properties
`which distinguish lasers from non-laser light diodes. Elec-
`tromagnetic wavelengths in the range of 400-2000 nm (both
`visible and invisible irradiation) provide non-ionizing radia-
`tion that does not induce mutagenic or carcinogenic eifects.
`After over twenty years of clinical application of low-
`intensity light therapy, according to David Baxter (Thera-
`peutic Lasers. P. 62, 1997), to date no serious side effects
`have been reported in the literature.
`
`[0006] There are bio-energy light and heat generating
`apparatus combining both optical (visible) and infrared
`(invisible) with wavelengths ranging from 360 nm to 1,380
`nm. Prior patents disclosing such devices include Nos.
`4,232,678, 4,930,504, 5,500,009, 5,766,233, 5,800,479, and
`4,535,784. Such devices may include a laser, laser diodes, or
`light emitting diodes to produce bio-energy which does not
`have a the potential for biological reaction in cells as does
`ionizing radiation in ultraviolet lights.
`
`tissue using
`[0007] Devices for stimulating biological
`low-intensity light energy to stimulate acupuncture points
`are disclosed in US. Pat. Nos. 6,013,096, 6,238,424; 6,063,
`1089; 6,471,716; and 6,074,411(Lai et al.), which describes
`multi-diodes, self-adhesive using holder to attach diode
`modules onto patient’s body. However, Lai’s design can
`produce inaccuracy in terms of the thickness changes to the
`actual depth of acupuncture points. Furthermore, by placing
`a diode laser module into a counterbored hole in a holder,
`
`that device has difficulty maintaining an exact illumination
`90° angle because the holder is made of soft, plastic foam
`paper.
`
`[0008] For ideal biological tissue stimulation, a combina-
`tion of wavelengths must be used to achieve illumination to
`specific depths at acupuncture points and to stimulate sev-
`eral tissue layers to the specific depths simultaneously. A
`third LED is added to the wand to produce therapeutic heat
`as moxibustion in TCM of specific light color of color
`therapy principles. Plural probes and wands provide the
`ability to treat a number of symptoms by simultaneously
`stimulating a plurality of acupuncture points. The probes and
`wands are made self-adhesive with a double-sided, non-
`allergenic tape to avoid the inconvenience of hand-held
`models (with which inconsistent radiation can result from
`movements of the practitioner/patient during treatment). The
`apparatus also saves time by treating more than one area at
`once.
`
`[0009] Abenefit of the present invention is that if the depth
`of an acupuncture point is variable, a practitioner can set a
`specific depth of each point in controlling software, provid-
`ing more accurate treatment at that point’s location. A fixed
`preset illumination depth (for example 3 cm depth, as in the
`Lai design) is not correct for all acupuncture points. For
`example, a hand acupuncture point is much closer to the
`surface than an acupuncture point located at the thigh of a
`patient.
`
`[0010] Whereas prior devices required one to set a single
`time for all treatments, the present invention provides for
`variable treatment times. To fulfill the principles of TCM,
`the practitioner needs to stimulate each TCM acupuncture
`point by one of the following choices: tonify, sedate or even
`method. The present invention is built to control the fre-
`quency, intensity, dosage, and pulsing of light to satisfy
`these principle requirements. Pulsing the emissions not only
`affects the stimulation/inhibition of the biological
`tissue
`reaction; it also increases the life span of the treatment unit
`compared to continuously emitting models.
`
`[0011] Taking the incident radiation and angle of reflection
`into account, the exact location of acupuncture point will be
`somewhat relative only. So another object of this invention
`is to minimize human errors in the complicated setting of
`depths (depending on area), frequencies,
`intensities, and
`dosages.
`
`[0012] An apparatus according to this invention is an
`automated system,
`like a small computer, with specific
`operating software. Practitioners need only select a certain
`part or treatment area of the body; then the software auto-
`matically sets the frequency,
`intensity, and dosage and
`memorizes the settings for the next time. While the auto-
`matic mode is particularly convenient for the practitioner,
`the invention also provides an optional manual mode, allow-
`ing for more flexibility in treatment.
`
`the probes and
`[0013] An important advantage is that
`wands may be started and stopped at the same time, so that
`they stimulate the body simultaneously to create an ideal
`effect, considering that the human body is an integrated
`system.
`
`[0014] The invention combines techniques and methods
`from several different areas of medicine into an inventive
`
`treatment method. It also enables one to apply acupuncture
`
`0012
`
`0012
`
`

`

`US 2005/0228463 A1
`
`Oct. 13, 2005
`
`in TCM, or Prana in
`and moxibustion to regulate Qi
`Ayurvedic, or vital life force of Hippocrates, without using
`metal needles or burning wools.
`
`light therapy applies the color principle, which corresponds
`to the five elements of TCM, including the benefits from the
`color spectrum.
`
`[0015] One can stimulate the production of certain hor-
`mones and enzymes, without the complication of injecting
`synthesized materials, by placing the plural probes and
`wands at specific glands’anatomical location to affect the
`endocrine system. By using LEDs of five different colors
`(such as white, blue, green, red, and yellow), one can
`perform color therapy. According to the TCM, these colors
`correspond to the five elements of the world. Red and
`infrared diodes are absorbed by the skin, muscles, tissues,
`and bones and work at the cellular level. The color red
`
`represents the element fire, or the cardiovascular system.
`Yellow represents the element earth, and provides a neutral/
`central balance state of the body, as related to the stomach.
`The yellow lights can be a great stimulant for the nervous
`system as well as toning muscles (spleen dominates muscle
`according to TCM). White represents the metal element and
`transformation of the body system that relates to your lung
`system, especially allergies. Blue represents the water ele-
`ment that relates to the kidney and your willpower; it is best
`for calming and gives a relaxing effect on treatment therapy.
`Green represents the wood element in TCM, which relates to
`the liver, tendons, and emotional state (stress), harmonizing
`the bio-electromagnetic energy field that surrounds our
`body.
`
`[0016] Light is bio-energy that moves in a wave pattern.
`For this reason, the inventive method incorporates sound
`therapy’s wave patterns, which harmonizes the endogenous
`rhythm of the organs and provides a new generation of
`therapy to enhance the natural building process of biological
`tissues.
`
`the body with
`[0017] The method and apparatus treat
`bio-energy light and heat for various conditions. Using this
`bio-energy light and heat, the apparatus applies energy to
`patients for the benefits of healing. As modern quantum
`physics teaches us that all matter is composed of vibrating
`packets of energy (quanta) that appear to us as particles, so
`bio-electromagnetic energy is present in all living things
`with its own specific frequency range, both measurable
`(frequency of electromagnetic spectrum, such as light
`(color) and sound) and unmeasurable by conventional sci-
`entific methods. We live in a world that is surrounded and
`
`affected by the various interconnected magnetic fields of
`energy. According to Oriental medicine (Ayurvedic and
`Traditional Chinese Medicine), a human being is a whole, a
`small universe that is composed of a body, mind, and spirit
`in a state of harmony including the free flow of invisible
`vital energy (life force), known as Qi in TCM and Prana in
`Ayurvedic, throughout the body. Illness is understood to be
`a result of the disharmonization of energy. BELG medicine
`aims to restore the harmonious interaction of energy within
`the patients and their environment by using the inventive
`bio-energy light and heat device and BELG method. Instead
`of injecting healthy cellular materials into the body to
`promote regeneration in cells, BELG method and its devices
`provide a non invasive stimulation at cellular level without
`the complication of injection and cell rejection. At the same
`time, if stimulated at the endocrine system, restoration of the
`balance of natural hormone/enzymes will be restored with-
`out the actual procedure of hormone/enzyme replacement
`therapy. Through BELG method, energy and light/colored
`
`[0018] BELG methods and devices are the perfect answer
`for oriental medicine. The invention is especially able to
`regulate and harmonize the vital life force known as Qi in
`TCM/Prana in Ayurvedic without using a metal needle or
`burning moxa wool for heat. In other words, energy, light
`(colored light) and sound therapy are similar because all of
`them are just different types of wavelengths that generated
`light beam through the inventive equipment for therapy
`purposes.
`
`[0019] At the same time, neural therapy can be carry out
`to remove short circuits in the human’s electrical network in
`
`the absence of anesthetic injection. Another important aspect
`of BELG method and devices is its ability to incorporate
`longevity medicine into the practice. By balancing the
`biochemistry of aging (such as stress hormones/enzymes
`hclicasc ) as well as enhancing cell functions to boost up
`immune system,
`the aging process may be slowed. The
`invention also relates to the equipment for stimulating
`mammal tissue with bio-energy light and heat therapy. The
`equipment has a power source and a central microprocessor
`that controls twelve other probes and wands to provide
`bio-energy. The invention works like a small computer with
`preset protocols for exact frequency, intensity, and time of
`specific probes/wands to be activated, in order to eliminate
`human error. Another unique feature is that practitioners are
`able to select a variety of preset protocols or set their own
`preferred selections.
`
`SUMMARY OF THE INVENTION
`
`[0020] The inventive device provides an apparatus for
`treating a disorder of a biological
`tissue in manual by
`emitting bio-energy light and therapeutic heat having auto-
`mated selections on time protocol to frequency, intensity,
`and dosage.
`
`[0021] This invention is characterized by the use of dif-
`ferent wavelengths combination. For example, one wave-
`length is applied for penetrating a certain bio-tissue layer
`while another different wavelength is used for penetrating a
`deeper layer, and so on. The idea is to combine more than
`one wavelength to stimulate diiferent bio-tissue simulta-
`neously to achieve a chain reaction through the whole body.
`
`[0022] Accordingly, the present invention is directed to a
`treatment system comprising:
`
`(a) a power source for providing power to a central
`[0023]
`microprocessor; a central microprocessor running software
`(which can be updated and monitored from the Internet)
`having stored time protocols that specify frequency, inten-
`sity, and dosage suitable for treating a range of disorders of
`biological tissue and a means for manually specifying pro-
`tocols;
`
`(b) a plurality of independent microprocessors to
`[0024]
`provide individual specific selection, plus paired indicator
`monitoring lights;
`
`(c) means for a central microprocessor, the control
`[0025]
`for pulsing the bio-energy light emitting, ranging from 1 to
`256 different digital frequencies, intensity, and time interval
`from 5-30 minutes of each output voltage, of each other 12
`
`0013
`
`0013
`
`

`

`US 2005/0228463 A1
`
`Oct. 13, 2005
`
`individual microprocessors are totally in control and moni-
`tored to give the design to stimulation or inhibition of tissue,
`means of pulsing the bio-energy-emitting gives the life span
`to the unit longer comparing to a continue emitting model,
`and preventing the plateau effect of stimulations;
`
`[0026]
`
`(d) safety means for preventing overexposure;
`
`(e) means for displaying a shut down screen show-
`[0027]
`ing probe and wand status at all
`times including their
`frequency, intensity, dosage, and time protocol selections,
`and the remaining time status; and
`
`a plurality probes and wands, each adapted to
`[0028]
`produce light of a wavelength from 360 nm to 1,380 nm, and
`optionally a second wavelength of from 400 nm to 1,300 nm,
`including a color LED or SLD.
`
`[0029] The apparatus provides light sources of different
`colors; these correspond to the five elements in TCM for
`therapeutic purposes. For example, a red diode is best to be
`absorbed by the skin, muscle, tissues and bone for biochemi-
`cal reaction at cellular level. A yellow diode provides a
`harmonized stage of the body. A white diode enhances the
`immune system which also will fight allergy. A blue diode
`gives a calming and relaxing effect to the body. A green
`diode helps control stress. Each optical source may be, for
`example, a laser, laser diode, a super luminous diode or an
`LED. Any combination of the various sources can be applied
`simultaneously. This gives the practitioner the ability to
`stimulate the biological tissue at different levels, such as the
`cell membrane, mitochondria, organelle, etc.
`
`[0030] Another aspect of the invention relates to a method
`for stimulating the natural healing process of the biological
`tissue known as BELG method, which combines key prin-
`ciples from nine different areas of medicines into one. The
`inventive apparatus is able to regulate Qi and Prana, vital
`living life force without the complication of metal needles,
`as in acupuncture.
`
`[0031] BELG—the inventive method—stimulates at cel-
`lular level to enhance ATP production, protein synthesis,
`DNA and RNA formation, and many neuro-transmitter in
`pain control. At the tissue level, better blood circulation;
`new blood and lymphatic vessels are formed; and collagen
`is synthesized to assist better wound healing. All
`these
`advantages are obtained, without the complexity of gene
`therapy or hormone/enzyme replacement therapy, by com-
`bining different wavelengths, frequency, intensity, and dos-
`ages at each treatment location.
`
`[0032] The inventive BELG method uses matching wave-
`lengths, as the sounds in Qi Gong therapy have been used,
`but using wavelengths from 360 nm to 1,380 nm. The
`treatment protocol, for example, a dose of from 0.5 -50J/cm2,
`an intensity of from 0.5-6000 W/cm2 and a wavelength from
`360 nm to 1380 nm, is set for each treatment location.
`
`[0033] The inventive apparatus may be used to treat a
`wide range of biological tissue dysfunctions or their symp-
`toms, including:
`
`a. Chiropractic medicine- pain management, tissue
`[0034]
`rehabilitation, nerve irritation, and spinal bone spur.
`
`b. Oriental medicine—regulates Qi and blood for
`[0035]
`disharmonized body to restore the balance states of the
`mind, body, and spirit.
`
`c. Pediatric medicine—middle ear infection, tooth-
`[0036]
`ache, sore throat, cough, running/bleeding nose, indigestion,
`constipation, and diarrhea.
`
`d. Podiatric medicine—pain management,
`[0037]
`injuries, nerve irritation, and heel spurs.
`
`tissue
`
`e. Substance/chemical dependency—drug addic-
`[0038]
`tion, smoking, mood swing, weight management.
`
`Internal medicine—immune system enhance-
`f.
`[0039]
`ment, liver inflammation, liver cirrhosis, hepatitis, diabetes
`types II, hemorrhoid, benign cyst, small gall bladder/kidney
`stones, and regulation of secretion of hormones and
`enzymes.
`
`post
`g. Neurology medicine—semi-paralysis
`[0040]
`stroke, spinal cord injuries, nerve irritation, and multiple
`sclerosis.
`
`h. Dermatological medicine—bums, acne, ulcers
`[0041]
`of different etiology such as venous ulcer, diabetic ulcer,
`pressure ulcer, and post traumatic ulcer.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0042] Amore complete appreciation of the present inven-
`tion and its scope, and the manner in which it achieves the
`above noted improvements can be obtained by referring to
`the following detailed description of presently embodiments
`of the invention taken in connection with the accompanying
`drawings plus graphs which are briefly summarized below
`and the claims.
`
`[0043] FIG. 1 is a schematic flow chart of the develop-
`ment of BELG treatment method protocols.
`
`[0044] FIG. 2 is a perspective view, from the front, of an
`apparatus embodying my invention;
`
`[0045] FIG. 3 is a rear elevation of the apparatus;
`
`[0046] FIG. 4 shows a wand, probe, and ear probe accord-
`ing to the invention;
`
`[0047] FIG. 5. shows the locations for placing wands and
`probes along the umbilicus for diabetes type II condition;
`
`[0048] FIG. 6ais a graph showing the Gaussian distribu-
`tion of the depth of penetration, the exponential attenuation
`of light radiation intensity within irradiated tissue;
`
`[0049] FIG. 6bdepicts the approximate absorptions curves
`for water, oxygenated and reduced haemoglobin, and mela-
`nin; and
`
`[0050]
`tics.
`
`FIGS. 7a-7c graphically illustrate recovery statis-
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`
`[0051] Amethod embodying the invention is illustrated in
`FIG. 1. Selected treatment protocols may be stored in a base
`unit 18 (FIG. 2), which has twelve individual microchips.
`The microchips are controlled by a central microprocessor.
`The system may be powered by any standard electrical
`power source. A screen window 16 displays the status of
`each individual channel: its frequency, intensity, and time.
`Each of those levels can be adjusted by a set of wands, arrays
`and probes that can be checked by a phototransistor 10. A
`count down clock and an audio beeper on the screen 16
`
`0014
`
`0014
`
`

`

`US 2005/0228463 A1
`
`Oct. 13, 2005
`
`signal and automatically turn off light output of all wands
`and probes at a time set. Each wand ,array and probe are
`independently set, run, and monitored by corresponding red
`lights 14. There is a flexible treatment protocol for each
`element; the wands and probes can all be activated simul-
`taneously, or specific selected wands and probes may be run
`individually. Each of the twelve channels is independently
`operated and set.
`
`[0052] There are a variety of preset treatment protocols
`from which to choose, each including parameters of fre-
`quency, pulse duration, intensity, and time, which can be
`selected for the optimal dosage to treat a particular disorder.
`The clinically proven treatment dosage is set in a data bank
`by the software, as indicated in Table 1.
`
`Area
`
`Arm (upper)
`Back
`Buttock
`Chest, Abdomen
`Ear
`Face
`Finger
`Foot
`Forearm
`Hand
`Head
`Leg (lower)
`Nape
`Neck
`Thigh
`The
`
`Dep h
`(mm)
`
`
`
`10— 5
`10—20
`10—50
`5— 0
`2
`6— .2
`2—1
`2—:
`3— 5
`3— 0
`5— 0
`5—20
`—— 0
`
`——8
`10—50
`2—:
`
`TABLE 1
`
`Frequency
`
`Intensity
`
`Duration
`(min)
`
`6-7—8—9
`6-7
`4-5-6-7
`7-8
`9
`6-7—8
`9
`8-9
`6-7—8
`7-8
`7-8
`5-6-7—8
`7-8
`7-8-9
`3-4-5-6-7
`8-9
`
`8, 9
`8, 9, 10
`9, 10
`8, 9
`7, 8
`7, 8
`8, 9
`8,9,10
`8, 9
`8, 9
`7, 8
`8, 9
`7, 8
`7, 8
`9, 10
`8,9,10
`
`25
`30
`30
`25
`20
`20
`20
`30
`25
`25
`20
`30
`20
`20
`30
`30
`
`Intensity is the rate of bio-light energy delivery per
`[0053]
`unit area of bio-tissue/skin, expressed herein in units of
`milliwatts per square centimeter (mW/cmz). Real intensity
`on the skin surface depends on light reflection and scattering
`from the skin and underlying tissue layers.
`
`techniques,
`[0054] For applications using non-contact
`applied power must be adjusted to compensate for reflection.
`The reflection coefficient R is 0.4-0.75, depending on wave-
`length and skin type and condition. Back scattering has to be
`taken into account for dosimetry as well. In contact tech-
`nique applications, less power is lost, due to the repeating
`light reflection back to skin surface from optical source unit.
`Therefore the required light intensity is different, depending
`on the technique chosen (contact or non-contact).
`
`[0055] The “photo-bio-modulation” phenomenon can be
`best activated within a certain range of wavelengths. For
`example, collagen Type 1 production is thought
`to be
`affected by bio-energy light in an inverse manner to fibro-
`blast proliferation. When cell proliferation is increased,
`collagen Type I production is decreased and vice versa (Van
`Breugel and Bar, 1992, Laser Surg. Med. 12:528-537).
`
`[0056] Bio-energy light intensity decreases with depth. In
`skin and subcutaneous tissue layers, light intensity can be
`approximately described by Beer’s Law, which assumes that
`the incident light has exponential attenuation (see FIG. 6.1)
`according to the equation
`
`Iz=IincTyz
`where:
`
`[0057]
`
`IZ=the irradiance (W/cm2 or mW/cmz) at a
`[0058]
`given depth,
`
`Iinc=incident irradiance (W/cm2 or mW/cmz)
`[0059]
`at the surface of the skin,
`
`[0060]
`
`z =depth in tissue (cm), and
`
`[0061]
`where
`
`y=total attenuation coefficient
`
`(cm—1)=a+s,
`
`[0062]
`
`a=absorption coefficient (cm—1) and
`
`[0063]
`
`s=scattering coefficient (cm—1).
`
`[0064] The absorption and tissue scattering of photons add
`to the total amount of light energy within a given volume of
`tissue, or more correctly,
`the light fluctuates within the
`tissue. Light distribution is a relative radiation transfer
`theory, Mie theory. Thus the light distributions must be
`looked at in two or three dimensions using the so-called
`Monte Carlo method (Keijzer et al 1989) which computes a
`random “walk” for each proton and flow the photon until it
`is absorbed. Light distribution is then estimated from the
`distribution of absorbed photons (see FIG. 6.2). Suitable
`intensities for ideal bio-stimulation are in the range of from
`0.1-5000 mW/cmz. For stimulating healing of an ulcer/
`wound, intensity may preferably be in the range of from 14to
`80 mW/cmz, depending on tissue pathologies. From expe-
`riences and clinically proofs, the ideal dosages for treatment
`are in the range of from 0.1-21J/cm2; the frequencies are in
`the range of from 5-200 Hz; and the wavelengths range from
`632 nm to 1300 nm, depending on bio-tissue pathologies.
`
`[0065] An apparatus for harmonizing energy in Auyverdic
`therapy with non-ionizing low level bio-energy includes a
`power source for providing power to light sources which
`generate bio-energy light beams for healing purposes. The
`light sources include multiple arrays of both visible and
`invisible light emitting devices for providing a harmonizing
`effect on the total energy of the body by balancing all the
`energy centers of the body.
`
`[0066] The light sources preferably have wavelengths in a
`range of from 530-890 nm, from 900-960 nm, or from
`980-1380 nm.
`
`[0067] Any of the wavelengths can be turned on or off as
`needed to treat a specific condition, and preferably, different
`wavelengths may be selected simultaneously to stimulate
`different tissue layers for physiological effect.
`
`[0068] The apparatus preferably includes means for oper-
`ating the light source in a repeated pulse mode having a
`pulse frequency in a range from 5 to 200 Hz.
`
`[0069] The bio-energy light parameters are determined
`automatically by preset protocols defining wavelength,
`intensity, dosage and treatment values, or manually, as
`preferred.
`
`[0070] A count down clock, controlled by software, may
`be included which automatically shuts off the apparatus at a
`preset time.
`
`[0071] Patients having high blood pressure were treated
`with the apparatus described above by the following
`method:
`
`0015
`
`0015
`
`

`

`US 2005/0228463 A1
`
`Oct. 13, 2005
`
`a) applying light energy with an ear probe to each
`[0072]
`ear at the auricular helix crust tubercle/liver yang acupunc-
`ture point to control blood pressure,
`
`b) if the heart is rate greater than a predetermined
`[0073]
`high limit, then applying light energy with a probe from 2.0
`to 2.5 inches above the wrist crest at the middle of P-6
`
`acupuncture point,
`
`c) determining which of the internal organ(s) is/are
`[0074]
`the cause for high blood pressure, then applying light energy
`with respective wands at the particular organ(s),
`
`d) continuing treatment for one week, then if the
`[0075]
`blood pressure is stable, slowly decreasing the medication
`dosage to half of the original dosage,
`
`[0076]
`
`e) repeating steps a-c for the next three weeks, then
`
`f) measuring the blood pressure daily for further
`[0077]
`evaluation and, if the blood pressure is stable at the normal
`level, then
`
`g) stopping treatment after a minimum of two
`[0078]
`months and checking up every one to three months there-
`after or, if the blood pressure is not decreased and stable,
`then
`
`[0079]
`
`h) continuing treatment by repeating steps a-c.
`
`[0080] Patients having diabetes type II were treated by:
`
`a) applying light energy with an ear probe to the
`[0081]
`mouth area of auricular acupuncture point, a wand at the
`stomach area of auricular acupuncture point, another wand
`at the subcortex area of auricular acupuncture point,
`
`b) placing another wand 2.0-2.5 inches lateral to
`[0082]
`the right side of the umbilicus of the patient and another
`wand at 135° to the umbilicus and about 2-2.5 inches away,
`
`c) placing a probe 1.5-2.0 inches above the umbi-
`[0083]
`licus, and another probe at 225° to the umbilicus and about
`2.0-2.5 inches away,
`
`[0084]
`
`d) continuing treatment for one week, then
`
`e) measuring the glucose level to check if it is
`[0085]
`stable and decreased and if so, then
`
`f) reducing medication to half then repeating steps
`[0086]
`a-d or, if the glucose level is increased or unstable then
`
`g) repeating steps a-d without reducing the medi-
`[0087]
`cations until the glucose level stays stable and
`
`[0088]
`
`h) continuing the treatment for one to three months.
`
`[0089] Semi-paralyzed patients were treated post-stroke
`with a method which included steps of:
`
`placing the applicators at acupuncture points cor-
`[0090]
`responding to observed symptoms,
`
`placing a wand of mixed wavelengths at the elbow
`[0091]
`joint-anterior aspect of LI-11 acupuncture point and at the
`knee joint of the posterior side of UB-40 acupuncture point
`on a problem side,
`
`placing other probes as follows:
`[0093]
`[0094]
`a first probe at the shoulder mid point of the
`joint of LI-15 acupuncture point,
`[0095]
`a second probe at the deltoid muscle end,
`3-3.5 inches below the top of the shoulder joint, of
`the LI-14 acupuncture point,
`[0096]
`a third probe at the 1-1.5 inches away from the
`web of the thumb and index fingers, of LI-4 acu-
`puncture point,
`[0097]
`a fourth pr

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket