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WO2025166282A1 - Dispositifs de traitement de maladies et d'états pathologiques - Google Patents

Dispositifs de traitement de maladies et d'états pathologiques

Info

Publication number
WO2025166282A1
WO2025166282A1 PCT/US2025/014184 US2025014184W WO2025166282A1 WO 2025166282 A1 WO2025166282 A1 WO 2025166282A1 US 2025014184 W US2025014184 W US 2025014184W WO 2025166282 A1 WO2025166282 A1 WO 2025166282A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical device
cases
meters
disease
subject
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/014184
Other languages
English (en)
Inventor
James Zhou LIU
Yuehua GU
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tesla Biohealing Inc
Original Assignee
Tesla Biohealing Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tesla Biohealing Inc filed Critical Tesla Biohealing Inc
Publication of WO2025166282A1 publication Critical patent/WO2025166282A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/74Synthetic polymeric materials
    • A61K31/745Polymers of hydrocarbons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/12Magnesium silicate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/26Iron; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/34Copper; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/44Elemental carbon, e.g. charcoal, carbon black
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients

Definitions

  • a medical device can comprise a substantially heterogeneous mixture of: (a) a stone selected from the group consisting of: a diamond, an amethyst, a tourmaline, a jade, an obsidian, and any combination thereof; (b) a sand comprising at least about 95% silicon dioxide by weight; (c) a metal selected from the group consisting of: a copper, an iron, and any combination thereof; (d) a polymer selected from the group consisting of: an isoprene rubber, a butyl rubber, a cellulose, a polysaccharide, or any combination thereof; (e) a water; and (d) a supporting material selected from the group consisting of: a grout, a modified sulfur cement, an agar, and any combination thereof.
  • the stone, the sand, the metal, and the polymer can comprise particles that each comprise a particle size diameter ranging from about 0. 1 mm to about 5 mm.
  • the medical device can comprise biophotons as measured by a biophoton detector.
  • the weight to weight ratio of the stone, the sand, the metal, the polymer, and the water can be equal.
  • the weight to weight ratio of the stone, the sand, the metal, the polymer, the water and the supporting material can be about 10% the stone: 10% the sand: 10% the metal: 50% the polymer: 10% the water: and about 10% the supporting material.
  • the stone can be the diamond.
  • the stone can be the amethyst. In some embodiments, the stone can be the tourmaline. In some embodiments, the stone can be the jade. In some embodiments, the stone can be the obsidian. In some embodiments, the metal can be the copper. In some embodiments, the metal can be the iron. In some embodiments, the polymer can be the isoprene rubber. In some embodiments, the polymer can be the butyl rubber. In some embodiments, the polymer can be the cellulose. In some embodiments, the cellulose can comprise an alpha cellulose or a salt thereof. In some embodiments, the polymer can be the polysaccharide.
  • the polysaccharide can comprise a hyaluronic acid or a salt thereof.
  • the supporting material can be the grout.
  • the supporting material can be the modified sulfur cement.
  • the supporting material can be the agar.
  • Also disclosed herein are methods comprising placing the medical device disclosed herein within about 0.1 meters to about 10 meters from a biological system for at least 15 minutes.
  • the biological system can be a human, an animal, a microbial culture, or a plant.
  • a method can comprise placing a medical device disclosed herein within about 0. 1 meters to about 5 meters from a subject for at least about 1 hour per day.
  • the medical device can be placed within about 0.1 meters to about 5 meters from the subject for at least about 8 hours per day.
  • the subject can have an increase in their Stroke Impact Scale (SIS) score after about 1 week of treatment as compared to a subject who was not within about 0. 1 meters to about 5 meters from a medical device for at least about 1 hour per day.
  • SIS Stroke Impact Scale
  • the subject can have an increase in their SF-36 score after about 1 week of treatment as compared to a subject who was not within about 0. 1 meters to about 5 meters from a medical device for at least about 1 hour per day. In some embodiments, the subject can have an increase in their stroke recovery rate score after about 1 week of treatment as compared to a subject who was not within about 0. 1 meters to about 5 meters from a medical device for at least about 1 hour per day. In some embodiments, the subject can have an increase in their neurological exam score after about 1 week of treatment as compared to a subject who was not within about 0. 1 meters to about 5 meters from a medical device for at least about 1 hour per day.
  • the method can comprise placing the medical device disclosed herein within about 0. 1 meters to about 5 meters from a subject for at least about 1 hour per day. In some embodiments, the medical device can be placed within about 0. 1 meters to about 5 meters from the subject for at least about 8 hours per day.
  • the disease or condition can be selected from: an Alzheimer’s disease, a Parkinson’s disease, a Traumatic Brain Injury (TBI), a depression, a stroke, an epilepsy, a cancer, an anemia, a long COVID- 19, an asthma, a Chronic Obstructive Pulmonary Disease (COPD), a glaucoma, a mitochondrial deficiency, a diabetes, a hypertension, an insomnia, a chronic pain, an acute pain, a neuromuscular disease, a kidney disease, and any combination thereof.
  • TBI Traumatic Brain Injury
  • COVID Chronic Obstructive Pulmonary Disease
  • COPD Chronic Obstructive Pulmonary Disease
  • a glaucoma a mitochondrial deficiency
  • a diabetes a hypertension
  • an insomnia a chronic pain, an acute pain, a neuromuscular disease, a kidney disease, and any combination thereof.
  • the method can comprise placing a medical device within about 0.1 meters to about 5 meters from the subject for at least about 1 hour per day.
  • the medical device can comprise a substantially heterogeneous mixture of: (a) a stone selected from the group consisting of: a diamond, an amethyst, a tourmaline, a jade, an obsidian, and any combination thereof; (b) a sand comprising at least about 95% silicon dioxide by weight; (c) a metal selected from the group consisting of: a copper, an iron, and any combination thereof; (d) a polymer selected from the group consisting of: an isoprene rubber, a butyl rubber, a cellulose, a polysaccharide, or any combination thereof; (e) a water; and (d) a supporting material selected from the group consisting of: a grout, a modified sulfur cement, an agar, and any combination thereof; wherein the stone, the sand, the metal, and the polymer comprise particles that each comprise a particle size diameter ranging from about 0.
  • the method comprises treating the Alzheimer's disease, the dementia, the Parkinson's disease, the TBI and the depression in the subject in need thereof.
  • the supporting material can be the grout.
  • a weight to weight ratio of the stone, the sand, the metal, the polymer, the water and the supporting material can be about: 10% the stone, 10% the sand, 10% the metal, 50% the polymer, 10% the water, and about 10% the supporting material.
  • the stone can be the tourmaline.
  • the disease can be the long COVID-19.
  • the disease can be the Alzheimer’s disease.
  • the disease can be the dementia. In some embodiments, the disease can be the Parkinson’s disease. In some embodiments, the disease can be the TBI. In some embodiments, the disease can be the depression. In some embodiments, metal can be the copper.
  • the polymer can be the isoprene rubber. In some embodiments, the polymer can be the butyl rubber. In some embodiments, the polymer can be the cellulose and can comprise an alpha cellulose or a salt thereof. In some embodiments, the polymer can be the polysaccharide and can comprise a hyaluronic acid or a salt thereof. In some embodiments, the supporting material can be the modified sulfur cement.
  • the medical device can be placed within about 0.1 meters to about 5 meters from the subject for at least about 1 or 8 hours per day for at least 1 week.
  • the subject in need thereof can have an increase in an SF-36 score after about 4 weeks of treatment as compared to a subject who was not treated with the medical device.
  • the subject in need thereof can have an increase in a physician-conducted neurologic examination score after about 4 weeks of treatment as compared to a subject who was not treated with the medical device for at least about 1 hour per day.
  • the substantially heterogeneous mixture can be a solid mixture.
  • FIGS. 1A-1B shows biophoton release from two different medical devices.
  • FIG. 1A shows the biophoton release from Device A
  • FIG. IB shows the biophoton release from Device B released as measured by a MIRA camera.
  • the Y-axis of the figures indicates the amount of biophotons released
  • the X-axis shows the captured image frame of the recording by the camera over time.
  • FIG. 2 shows the difference of the biophotons released from a single stone and a finished product (containing a mix of materials) detected by a biophoton detection camera.
  • the Y-axis shows the strength of the biophoton signal.
  • the X-axis shows the time in minutes.
  • FIG. 3 shows the Stroke Impact Scale (SIS) results of patients with stroke during a randomized double blinded and placebo controlled clinical study.
  • the Y-axis of the figure indicates the SIS score percentage change, the X-axis shows the length of time of the study.
  • FIG. 4 shows the recovery rates of the patients with stroke during a randomized double blinded and placebo controlled clinical study.
  • the Y-axis of the figure indicates the stroke recovery rate score change as compared to baseline score, the X-axis shows the length of time of the study.
  • FIG. 5 shows the neurologic examination score of the patients with stroke during a randomized double blinded and placebo controlled clinical study.
  • the Y-axis of the figure indicates the neurological exam score
  • the X-axis shows the length of time of the study.
  • the black bars are the control patient group
  • the white bars are the treatment patient group.
  • FIG. 6 shows the Life Quality (SF-36 Score) change of the patients with stroke during a randomized double blinded and placebo controlled clinical study.
  • the Y-axis of the figure indicates the SF-36 score change (compared to 100% baseline score), the X-axis shows the length of time of the study.
  • FIG. 7 shows the difference readings of biophotons of a water bottle before and after being energized with a strong medical device.
  • FIG. 8 shows the Life Quality (SF-36) scores of Alzheimer’s patients treated with the medical device.
  • FIG. 9A - 9B shows the peripheral blood circulation score in the right and left side of the body from the baseline (before treatment) and after 2 and 4 weeks of treatment with the medical device in Alzheimer’s patients.
  • Biophoton therapies to restore cellular activities, to slow down aging, and to treat diseases and conditions, such as a stroke, a traumatic brain injury, an Alzheimer's Disease, a dementia, a Parkinson’s Disease, a chronic obstructive pulmonary disease (COPD), an asthma, a genetic mutation, a cancer, a chronic pain, or other diseases disclosed herein.
  • Biophoton therapies disclosed herein can be produced by a medical device.
  • a medical device comprises different materials that when combined produce biophotons.
  • kits comprising a medical device and methods for manufacturing the medical device.
  • a medical device can be placed near a subject and be used to produce biophotons for biophoton therapy of a subject.
  • the biophotons emitted by the medical device can be used to modulate biological processes and restore cellular function.
  • a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range.
  • description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1. 2, 3, 4. 5, and 6. This applies regardless of the breadth of the range.
  • a number can refer to that number plus or minus 10% of that number.
  • the term ‘about’ a range can refer to that range minus 10% of its lowest value and plus 10% of its greatest value.
  • determining means determining if an element may be present or not (for example, detection). These terms may include quantitative and/or qualitative determinations. Assessing may be alternatively relative or absolute. “Detecting the presence of’ includes determining the amount of something present, as well as determining whether it may be present or absent.
  • a “subject” may be a biological entity.
  • the biological entity' may be a plant, animal, or microorganism, including, for example, bacteria, viruses, fungi, and protozoa.
  • the subject may be tissues, cells and their progeny of a biological entity obtained in vivo or cultured in vitro.
  • the subject may be a mammal.
  • the mammal may be a human.
  • the subject may be diagnosed or suspected of being at high risk for a disease. In some cases, the subject may not be necessarily diagnosed or suspected of being at high risk for the disease. In some cases, the subject may be healthy (e.g., the subject may not have a significant disease).
  • a subject can be a child or an adult. In some cases, a subject can be about 1 day of age to about 18 years of age, 1 day of age to about 120 years of age, 18 years of age to about 120 years of age, or 60 years of age to about 120 years of age.
  • the term “at least partially” may refer to a qualitative condition that exhibits a partial range or degree of a feature or characteristic of interest.
  • at least partially can comprise a partial range or degree of a feature or characteristic of interest that is at least about: 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 99%, or 100% of the feature or characteristic.
  • in vivo may be used to describe an event that takes place in a subject’s body.
  • ex vivo may be used to describe an event that takes place outside of a subject’s body.
  • An “ex vivo” assay may not be performed on a subject. Rather, it may be performed upon a sample separate from a subject.
  • An example of an “ex vivo” assay performed on a sample may be an “in vitro” assay.
  • in vitro may be used to describe an event that takes place contained in a container for holding laboratory reagent such that it may be separated from the living biological source organism from which the material may be obtained.
  • in vitro assays may encompass cellbased assays in which cells alive or dead are employed.
  • In vitro assays may also encompass a cell-free assay in which no intact cells are employed.
  • treatment or “treating” are used in reference to a pharmaceutical or other intervention regimen (e.g., a biophoton therapy) for obtaining beneficial or desired results in the recipient such as reducing the symptoms of a stroke in a subject.
  • beneficial or desired results include but are not limited to a therapeutic benefit and/or a prophylactic benefit.
  • beneficial or desired results include but are not limited to treatment of a complication of a disease.
  • a therapeutic benefit may refer to eradication or amelioration of symptoms or of an underlying disorder being treated.
  • a therapeutic benefit may be achieved with the eradication or amelioration of one or more of the physiological symptoms associated with the underlying disorder such that an improvement may be observed in the subject, notwithstanding that the subject may still be afflicted with the underlying disorder.
  • a prophylactic effect includes delaying, preventing, or eliminating the appearance of a disease or condition, delaying or eliminating the onset of symptoms of a disease or condition, slowing, halting, or reversing the progression of a disease or condition, or any combination thereof.
  • a prophylactic benefit a subject at risk of developing a particular disease, or to a subject reporting one or more of the physiological symptoms of a disease may undergo treatment, even though a diagnosis of this disease may not have been made.
  • biophotons can be light-based particles that can have dual parti cl e/wave properties and can be used to treat a disease or condition of a subject or supplement the health of a subject.
  • biophotons can comprise a quantum particle.
  • a biophoton can comprise a photon.
  • a biophoton can comprise a photon of light in the ultraviolet and low visible light range that are produced by a system disclosed herein.
  • a biophoton can radiant emittance in the visible and ultraviolet frequencies ranges from 10 17 to 10 27 W/cm 2
  • a biophoton herein can be in the wavelength range of about 200 nanometers (nm) to about 800 nm.
  • a biophoton herein can be in the wavelength range of about 200 and 1300 nanometers.
  • a biophoton can comprise an infrared radiation.
  • infrared radiation can be electromagnetic radiation with wavelengths between 760 nm and 100,000 nm.
  • a biophoton can comprise a low-level light therapy (LLLT) or photobiomodulation (PBM).
  • LLLT low-level light therapy
  • PBM photobiomodulation
  • low- level light therapy (LLLT) or photobiomodulation (PBM) can comprise light at red and nearinfrared wavelengths (600-1000 nm).
  • far infrared light can be comprised in a biophoton.
  • a biophoton disclosed herein can penetrate the human body up to more than, less than, or equal to about: 0.5 inches, 1 inch, 2 inches, 3 inches, 4 inches, 5 inches, 6 inches, 7 inches, or 8 inches.
  • far infrared light can penetrate into the muscles, tissues, joints, and more.
  • biophotons can be produced by a medical device.
  • a biophoton can be produced at least in part by non-living material, such as inorganic material.
  • a biophoton can be produced at least in part by an organic material.
  • a “dose” can refer to a measured quantity of a therapeutic agent to be taken or administered at one time.
  • unit dose or “dosage form” may be used interchangeably and may be meant to refer to pharmaceutical drug products or other therapies in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components, in a particular configuration, and apportioned into a particular dose to be delivered.
  • unit dose may also sometimes encompass non-reusable packaging. More than one unit dose may refer to distinct pharmaceutical drug products packaged together, or to a single pharmaceutical drug product containing multiple drugs and/or doses. Types of unit doses may vary with the route of administration for drug delivery, and the substance(s) being delivered.
  • the terms “effective amount” or “therapeutically effective amount” of a therapy used to treat a disease may be an amount and/or duration of a therapy that may reduce the severity of a disease, reduce the severity of one or more symptoms associated with the disease or its treatment, or delay the onset of more serious symptoms of a disease.
  • An “effective amount” may be determined empirically and in a routine manner, in relation to the stated purpose
  • substantially can refer to a qualitative condition that exhibits an entire or nearly total range or degree of a feature or characteristic of interest. In some cases, substantially can refer to a total range or degree of a feature or characteristic of interest by about plus or minus: 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%,
  • substantially can refer to at least about: 70%, 75%. 80%, 85%, 90%, 95%, 99%, or 100% of the total range or degree of a feature or characteristic of interest.
  • a medical device can be referred to as a biophoton generator.
  • a medical device can be referred to as a bioenergy' generator.
  • a biophoton generator can comprise a medical device.
  • a bioenergy generator can comprise a medical device.
  • the medical device disclosed herein can include a stone, such as a diamond, an amethyst, a tourmaline, a jade, an obsidian, or any combination thereof.
  • a medical device herein can comprise a polymer such as a rubber.
  • a medical device herein can comprise a sand.
  • a medical device herein can comprise a metal and/or an alloy.
  • a medical device herein can comprise a stone, a sand, a polymer, a metal (or alloy), a water, or any combination thereof.
  • a medical device herein can comprise a supporting material to support a mixture of components.
  • an ingredient herein in a medical device can be further activated by using a larger medical device on an ingredient.
  • a medical device can substantially constantly generate and release biophotons in a 3 dimensional field.
  • a medical device herein can comprise a stone.
  • a medical device herein can comprise a mix of stones, for example 1, 2, 3, 4, 5 or more types of stones.
  • a particle size of a stone in a medical device can have a diameter of about 0.01 mm to about 5 mm.
  • a particle size of a stone in a medical device can have a diameter of about 0.1 mm to about 5 mm.
  • a particle size of a stone in a medical device can have a diameter of more than, less than or equal to about: 0. 1 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm.
  • a stone can comprise an amethyst, a tourmaline, a jade, an obsidian, or any combination thereof.
  • amethyst can have a trigonal crystal system and/or a Mohs Hardness value of about 7.
  • tourmaline can have a trigonal cry stal system and/or a Mohs Hardness value of about 7-7.5.
  • jade can have a monoclinic crystal system and/or a Mohs Hardness value of about 6-7.
  • obsidian can have a spherulites and/or a Mohs Hardness value of about 5-6.
  • tourmaline and jade can produce negative ions when it is heated up or at room temperature.
  • tourmaline can produce more than about 1500 negative ions per cubic centimeter when heated.
  • when heated jade can produce around 700 negative ions per cubic centimeter.
  • Tourmaline can be superconductive and can generate a natural infrared wave.
  • a jade can be a black jade, a blue jade, a green jade, a nephrite jade, a jadeite jade, an orange jade, a purple jade, a red jade, or any combination thereof.
  • a medical device herein can comprise a polymer.
  • a medical device herein can comprise a mix of polymers, for example 1, 2, 3, 4, 5 or more types of polymers.
  • a polymer herein is a rubber.
  • a polymer herein can comprise a cellulose.
  • a polymer herein can comprise a polysaccharide.
  • a cellulose can comprise a cellulose I, a cellulose II, a cellulose III, a cellulose IV. a salt of any of these, or any combination thereof.
  • a cellulose can comprise an alpha cellulose or a salt thereof.
  • a cellulose can comprise a beta cellulose, a gamma cellulose, or both. In some cases, a cellulose can comprise a hemicellulose, a cellulose ester, a cellulose ether, a salt of any of these, or any combination thereof.
  • a polysaccharide can comprise a hyaluronic acid, or a salt thereof. In some cases, a polysaccharide can comprise a starch, a glycogen, a galactogen, an inulin, an arabinoxylan, a chitin, a pectin, a heparin, a peptidoglycan, a salt of any of these, or any combination thereof.
  • the rubber can comprise an isoprene.
  • a rubber herein can be polymer of isoprene.
  • a rubber herein can be polymer of butyl.
  • a rubber herein can comprise a styrene-butadiene, a butyl, a nitrile, an ethylene propylene diene monomer, a silicone, a polyurethane, a hydrogenated nitrile, or any combination thereof.
  • the rubber can be a natural rubber.
  • a particle size of a polymer in a medical device can have a diameter of about 0.01 mm to about 5 mm or about 1 mm to about 2 mm.
  • a particle size of a polymer in a medical device can have a diameter of about 0. 1 mm to about 5 mm. In some cases, a particle size of a polymer in a medical device can have a diameter of more than, less than or equal to about: 0. 1 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm.
  • a medical device herein can comprise a metal or an alloy.
  • a medical device herein can comprise a mix of metals or alloys, for example 1, 2, 3, 4, 5 or more types of metals or alloys.
  • a metal can be in the form of a powder.
  • a particle size of a metal or alloy in a medical device can have a diameter of about 0.01 mm to about 5 mm.
  • a metal can be in the form of a powder.
  • a particle size of a metal or alloy in a medical device can have a diameter of about 0. 1 mm to about 5 mm.
  • a particle size of a metal or alloy in a medical device can have a diameter of more than, less than or equal to about: 0.1 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm.
  • a metal can comprise a copper, an iron, or both.
  • a metal or alloy can comprise an iron, a copper, a zinc, an aluminum, a calcium, a magnesium, a silver, a gold, a steel, or any combination thereof.
  • a medical device herein can comprise a sand.
  • a medical device herein can comprise a mix of sands, for example 1, 2, 3, 4, 5 or more types of sands.
  • the sand can comprise silicon dioxide.
  • the sand is substantially compnsed of silicon dioxide by weight.
  • a sand can comprise at least about: 1% , 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%,
  • a sand can comprise at least about 95% silicon dioxide by weight. In some cases, the sand comprises 100% silicon dioxide by weight. In some cases, a sand can comprise about: 1% to about 100%, 50% to about 100%, 75% to about 100%, 80% to about 100%, or 90% to about 100% of silicon dioxide by weight. In some cases, a particle size of a sand in a medical device can have a diameter of about 0.01 mm to about 5 mm. In some cases, a particle size of a sand in a medical device can have a diameter of about 0. 1 mm to about 5 mm.
  • a particle size of a sand in a medical device can have a diameter of more than, less than, or equal to about: 0.1 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm or 5 mm.
  • a medical device herein can comprise a water.
  • a water can be collected from a natural source.
  • a water herein can comprise a mix of natural water, for example 1, 2, 3, 4. 5 or more types of natural water can be mixed.
  • a water can be a distilled water.
  • a medical device can comprise supporting material.
  • a supporting material can comprise a grout.
  • a supporting material can comprise a concrete.
  • a supporting material can comprise an agar.
  • an agar can comprise an agar from a seaweed.
  • an agar is a food grade agar.
  • a supporting material can comprise a sulfur cement such as a modified sulfur cement.
  • a supporting material can comprise a cement and/or a polymer.
  • a supporting material can comprise adhesive composition.
  • a supporting material does not contribute to the production of biophotons in a medical device.
  • a supporting material can contribute to the production of biophotons in a medical device.
  • a medical device disclosed herein can continually generate biophotons for at least: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, or 10 years without adding any extra energy source.
  • the biophotons produced can penetrate the wall of the container, such as a metal container or a plastic container.
  • a biophoton can be detected outside of a container.
  • the medical device is active at room temperature and at temperatures less than room temperature or greater than room temperature.
  • the medical device is active at a temperature of more than, less than, or equal to about: 0 °C, 1 °C, 2 °C, 3 °C, 4 °C, 5 °C, 6 °C, 7 °C, 8 °C, 9 °C, 10 °C, 11 °C, 12 °C, 13 °C, 14 °C. 15 °C, 16 °C, 17 °C. 18 °C, 19 °C, 20 °C, 21 °C. 22 °C, 23 °C, 24 °C. 25 °C, 26 °C. 27 °C, 28 °C, 29 °C. 30 °C, 31 °C, 32 °C. 33 °C, 34 °C,
  • a medical device can be produced by methods disclosed herein.
  • materials for a biophoton can be selected, which can comprise: 1) a stone or a mix of stones; 2) a polymer such as a rubber; 3) a sand; 4) a metal; 5) a water; 6) a supporting material such as a grout; 7) or any combination thereof.
  • each different material in the medical device can be of the same size or be different sizes.
  • Each individual material in the medical device can be of the same size or be different sizes.
  • the ingredient can be in the form of small pieces of a material.
  • the material can be in the form of a granule, a particle, a grain, or a fragment.
  • raw material can be processed to be similar in size.
  • a material can be manufactured to have a particle diameter of about 0.01 mm to about 5 mm or about 0. 1 mm to about 5 mm.
  • the material can be in the shape of a sphere, an oval, an amorphous shape, a cube, a crystalline structure, or any combination thereof.
  • the diameter or the radius of a material can comprise from about: 0.001 mm to about 1000 mm, 0.001 mm to about .01 mm, 0.01 mm to about 1 mm, 0.01 mm to about 5 mm ,0. 1 mm to about 5 mm, 0. 1 mm to 50 mm, 0. 1 mm to about 100 mm, 1 mm to about 100 mm, 0.5 mm to about 50 mm, 1 mm to about 25 mm, or about 0. 1 mm to about 10 mm.
  • the diameter or the radius of a material can comprise more than about, less than about, or equal to about: 0.01 mm. 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm.
  • the length, width, or height of a material can comprise from about: 0.001 mm to about 1000 mm, 0.001 mm to about .01 mm, 0.01 mm to about 1 mm, 0.01 mm to about 5 mm, 0. 1 mm to 50 mm, 0. 1 mm to about 100 mm, 1 mm to about 100 mm, 0.5 mm to about 50 mm. 1 mm to about 25 mm. or about 0.1 mm to about 10 mm.
  • the length, width, or height of a material can comprise more than about, less than about, or equal to about: 0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm.
  • the use of large particles can reduce the amount of biophotons produced by a medical device as compared to the use of small particles in a medical device.
  • the materials in a medical device can be activated. In some cases, the materials in a medical device can be unactivated. In some embodiments, the materials of a medical device can be activated to produce additional biophotons as compared to unactivated materials. In some instances, the materials (e.g., the stones, sands, metal, polymer and/or water) can be activated by placing next to a strong field formed by using one or more medical devices.
  • the unactivated materials can be placed near the medical device for at least about: 2 hours, 4 hours, 6 hours, 8 hours, 10 hours. 12 hours. 16 hours, 24 hours, 48 hours, 72 hours, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, or 14 days to become activated.
  • the materials can be weighed to achieve an exemplary' ratio of activated materials.
  • a stone, a sand, a metal, and a water can be in a weight to weight ratio of about: 10%: 10%: 10%: 10%, and unactivated material at about 60%.
  • said ingredients of a stone, a sand, a metal, and a water can be 100g, 100g, 100g, 100g and unactivated material is 600g.
  • a stone, a sand, a metal, a polymer, and a water can be in a weight to weight ratio of about: 10%: 10%: 10%: 10%: 10% and unactivated material at about 50%. The ratio can be varied in a range.
  • a stone, a sand, a metal, and a water can be in a weight to weight ratio of about: 1%: 1%: 1%: 1% and unactivated material at about 96%.
  • a stone, a sand, a metal, a polymer, and a water can be in a weight to weight ratio of about:
  • a stone, a sand, a metal, and a water can be in a weight to weight ratio of about: 5%: 5%: 5%: 5% and unactivated material at about 80%.
  • a stone, a sand, a metal, a polymer, and a water can be in a weight to weight ratio of about: 5%:5%:5%:5%:5% and unactivated material at about 75%.
  • a stone, a sand, a metal, and a water can be in a weight to weight ratio of about: 15%: 15%: 15%: 15% and unactivated material at about 40%.
  • a stone, a sand, a metal, a polymer, and a water can be in a weight to weight ratio of about:
  • a polymer, a stone, a sand, a metal, and a water can be in a weight to weight ratio of about: 50% (polymer): 10% (stone): 10% (sand): 10% (metal): 10%(water) and unactivated material at about 10%.
  • a stone, a sand, a metal, a polymer, and/or a water can be in an equal weight to weight ratio.
  • a stone, a sand, a metal, a polymer, a water, and/or a supporting material can be in an equal weight to weight ratio.
  • the ratio can be varied in a range that those said ingredients of a stone, a sand, a metal, a polymer, and a water can be in a weight to weight ratio of 1% for one material and 1-99% for the other materials and 1-99% for the unactuated materials for a weight to weight ratio total of 100%.
  • a stone, a sand, a metal, a polymer, and/or a water can be in a weight to weight ratio with the other ingredients (e.g..
  • a stone, a sand, a metal, a polymer, and/or a water and unactive materials and be in an amount of about: 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%,
  • a stone, a sand, a polymer, a metal, and/or a water can be added to a mixture in a specific amount.
  • a stone, a sand, a polymer, a metal, and/or a water can be added in an amount that ranges from about: 1 mg to about 10 grams, 1 gram to about 10,000 grams, 1 gram to about 1 ,000 grams, 10 gram to about 100 grams, 50 grams to about 250 grams, 100 grams to about 1,000 grams, or about 1,000 grams to about 10,000 grams.
  • a stone, a sand, a polymer, a metal, and/or a water can be added in an amount of more than, less than, or equal to about: 1 mg, 10 mg, 100 mg, 1 gram (g), 5 g, 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 45 g, 50 g, 55 g, 60 g, 65 g, 70 g, 75 g, 80 g, 85 g, 90 g, 95 g, 100 g, 150 g, 200 g, 250 g, 300 g, 350 g, 400 g, 450 g, 500 g, 550 g, 600 g, 650 g, 700 g, 750 g, 800 g, 850 g, 900 g, 950 g, 1000 g, 1100 g, 1200 g, 1300 g, 1400 g, 1500 g. 1600 g, 1700 g, 1800
  • the materials for a medical device can be contacted and/or mixed together.
  • the materials are mixed in a substantially heterogeneous or substantially homogeneous mixture.
  • one or more of a stone, a sand, a metal, a polymer, a water, and an unactivated material are mixed.
  • the material are mixed by a mixer.
  • an unactivated ingredient is first added to the mixer then the activated materials are added to the mixer to create a mixed composition.
  • an activated material is first added to the mixer then the unactivated material is added to the mixer to create a mixed composition.
  • activated materials and unactivated materials are added to the mixer at the same time to create a mixed composition.
  • the substantially solid structure can be solidified after the materials are mixed together by different inactive materials such as grouts.
  • the medical device can produce biophotons day and night automatically and consistently without the use of other energy resources, such as electricity, light, or heat.
  • the materials for a medical device can be added into or to a container.
  • the materials are substantially mixed prior to adding the materials to a container.
  • a container can be a stainless steel container or a plastic container.
  • a container can be a glass container or an organic container such as a wood container.
  • the container comprises a stainless steel container, an aluminum container, or a mixture of both.
  • a container can be a mix of materials.
  • a container is a closed container.
  • a container is a sealed container.
  • the container may not substantially contribute to the production of biophotons.
  • the container may contribute to the production of biophotons.
  • the net w eight of the mix of materials can range from about: 1 gram to about 100 kg, 10 grams to about 100 kg. 1 gram to about 10 grams. 10 grams to about 100 grams, 50 grams to about 500 grams, 100 grams to about 1 kg, 500 grams to about 5 kg, 1 kg to about 20 kg, 1 kg to about 10 kg, 5 kg to about 25 kg, 20 kg to about 50 kg, or 50 kg to about 100 kg. In some cases, the net w eight of the mix of materials can be more than, less than, or equal to about:
  • a medical device can have a total filled or unfiled volume of about: 100 ml to about 10,000 ml, 240 ml to about 5,760 ml, about 200 ml to about 8,000 ml, 100 ml to about 1000 ml, 500 ml to about 5,000 ml, 1,000 ml to about 8,000 ml, 2,000 ml to about 6,000 ml or 5,000 ml to about 10,000 ml.
  • a medical device can have a total filled or unfiled volume of more than, less than, or equal to about: 10 ml, 100 ml, 200 ml.
  • the biophotons produced by a medical device are produced in a three-dimensional field and can penetrate body of a subject.
  • the biophotons produced by a medical device are effective and/or active on a subject at a distance in a range of about: 0. 1 meter to about 20 meters, 0. 1 meters to about 1 meter, 0.5 meters to about 3 meters, 1 meter to about 10 meters, 0.5 meter to 5 meters. 2 meters to 8 meters. 5 meters to about 15 meters or about 10 meters to about 20 meters.
  • the biophotons produced by a medical device are effective and/or active on a subject at a distance of more than, less than, or equal to about: 0.1 meters, 0.2 meters, 0.3 meters, 0.4 meters, 0.5 meters, 0.6 meters, 0.7 meters, 0.8 meters, 0.9 meters. 1 meters. 2 meters, 3 meters, 4 meters, 5 meters, 6 meters, 7 meters, 8 meters, 9 meters. 10 meters, 11 meters, 12 meters. 13 meters, 14 meters, 15 meters, 16 meters. 17 meters, 18 meters, 19 meters, or 20 meters.
  • the biophotons can be active on direct contact with a subject, for example if a subject is touching a medical device.
  • the strength of the photon field can correlate with the size of the device and the closeness from the user. For example, a medical device produces a larger biophoton dose when the subject is closer to the medical device.
  • the biophotons produced by a medical device can be measured with a biophoton detector.
  • the device in order to measure the production of biophotons the device must produce at least about 500 or 1000 biophotons per second.
  • biophotons can be measured at least in part by low-consumption high- sensitivity Complementary Metal Oxide Semiconductor (CMOS) sensors.
  • CMOS sensors can have resolution in the UV spectrum visual range and infrared range.
  • a biophotons can be measured by a MIRA camera.
  • a biophoton can be detected and/or measured with a photomultiplier or by a CCD camera (e.g., an ultra-low noise CCD camera).
  • a biophoton can be measured with a single photon detector.
  • a MIRA camera can be a Model 800, MIRA digital multispectral videocamera manufactured by The Daniele Gulla Laboratory, autoimmune Universitarie, Bologna, Italy.
  • the MIRA camera, used herein to capture photon and biophoton emissions, is a digital multispectral video camera.
  • UV-vis-NIR images ultraviolet/visible/near infrared spectroscopy
  • the video camera collects different frames and quickly compares the frames pixel by pixel.
  • the system amplifies the weak signal with a series of mathematical elaborations, namely a fast Fourier transform (FFT) pyramidal algorithm that paints the monochromatic parts in black and white while following a fixed color code scale.
  • FFT fast Fourier transform
  • the electromagnetic field variation and the photon flux increase exponentially.
  • the unstable flux is produced by microvariations and oscillations of the optical field (luminance and chrominance), which are likely to be of a quantum nature.
  • biophoton therapy can be administered by a medical device.
  • a biophoton therapy can be used to supplement and/or improve the health of a subject.
  • a biophoton therapy herein can be used to treat a symptom of a disease or condition.
  • a biophoton therapy disclosed herein can increase a blood circulation, remove a metabolic waste, treat a pain of a muscle, treat a joint pain, treat a muscle and/or joint stiffness, treat a joint pain associated with an arthritis, relieve a muscle spasm, treat a muscle strain, treat a muscular back pain, provide a muscle relaxation, or any combination thereof.
  • a biophoton therapy disclosed herein can be used to treat muscle pain, treat a pain, treat a headache, treat a muscle tension, treat a chronic pain, or any combination thereof.
  • a pain can be a back pain.
  • a pain can comprise an acute pain, a chronic pain or both.
  • a pain can comprise a neuropathic pain, a nociceptive pain, a radicular pain, or any combination thereof.
  • a biophoton therapy disclosed herein can be used to treat a migraine.
  • a migraine can comprise a hemiplegic migraine, an abdominal migraine, a vestibular migraine, a menstrual migraine, a migraine with brainstem aura, a medication overuse headache, a status migrainosus, a cluster headache, a sinus headache, a caffeine headache, or any combination thereof.
  • a biophoton therapy disclosed herein can be used to treat an arthritis.
  • an arthritis can comprise a rheumatoid arthritis.
  • an arthritis can comprise an osteoarthritis, a gout, a fibromyalgia, a childhood arthritis, an infectious arthritis, a psoriatic arthritis, an ankylosing spondylitis, or any combination thereof.
  • a composition herein can be administered to improve focus, improve a mood, promote brain health, and/or provide energy.
  • a biophoton therapy disclosed herein can be used to improve circulation, improve breathing, reduce inflammation, accelerate wound healing, normalize frequency of urination, or any combination thereof.
  • a biophoton therapy can be used to increase the intelligence level of a subject.
  • a biophoton therapy can be used to improve a strength, a mental exhaustion, a physical exhaustion, a libido, or any combination thereof of a subject.
  • a medical device can be used to enhance an athletic ability.
  • the subject can have a low IQ level.
  • a medical device can be used to improve the ability to focus.
  • a medical device herein can be used to treat a subject with a chronic fatigue, an insomnia, a mental condition, or any combination thereof.
  • a medical device herein can be used to treat a stress, treat a fatigue, or both.
  • a stress can be an acute stress, a chronic stress, a physical stress, a phycological stress, or any combination thereof.
  • a chronic fatigue system can comprise a physical exhaustion, a mental exhaustion, a difficulty walking or any combination thereof.
  • a biophoton therapy herein can be used to treat a symptom of a disease or condition.
  • a symptom of a disease or condition can comprise a fatigue, feeling tired weakness, brain fog (problems concentrating or thinking), a headache, a tremor, a rapid or pounding heartbeat, a feeling of skipped heartbeats (e.g., palpitations), a dizziness upon standing, a symptoms that worsen after physical or mental activity (e.g., as post-exertional malaise).
  • biophoton therapy disclosed herein can be used to treat a sleep disorder.
  • a biophoton therapy disclosed herein can increase sleep duration of a subject.
  • a sleep disorder can comprise restless legs syndrome, narcolepsy, a sleep apnea, a parasomnia, a sleep paralysis, a hypersomnia, a sleep walking disorder, a nightmare disorder, a bruxism or any combination thereof.
  • biophoton therapy disclosed herein can be used to treat an insomnia.
  • biophoton therapy disclosed herein can be used to treat a chronic fatigue syndrome.
  • biophoton therapy disclosed herein can be used to treat a chronic pain, an acute pain, a mild pain, a moderate pain, a severe pain, a very severe pain, and/or a worst possible pain.
  • biophoton therapy disclosed herein can be used to treat a mental disorder.
  • a mental disorder can comprise an anxiety disorders, a behavioral disorder, an emotional disorder, a bipolar disorder, a depression, a dissociation disorder, a dissociative disorder, an eating disorder, an obsessive compulsive disorder, a paranoia disorder, a post-traumatic stress disorder (PTSD), a psychosis, a schizophrenia, or any combination thereof.
  • biophoton therapy disclosed herein can be used to treat an attention-deficit- hyperactivity disorder (ADHD).
  • ADHD attention-deficit- hyperactivity disorder
  • a mental health disorder can comprise a generalized anxiety disorder, a social phobia, an agoraphobia, a claustrophobia, a panic disorder, an obsessive compulsive disorder (OCD), an autism, an oppositional defiant disorder, a conduct disorder, an anorexia, a major depression, a persistent depressive disorder, a bipolar disorder, a seasonal affective disorder, a postpartum depression, a premenstrual dysphoric disorder, an atypical depression, a treatment resistant depression, a bulimia nervosa, or any combination thereof.
  • OCD obsessive compulsive disorder
  • an autism an oppositional defiant disorder
  • a conduct disorder an anorexia, a major depression, a persistent depressive disorder, a bipolar disorder, a seasonal affective disorder, a postpartum depression, a premenstrual dysphoric disorder, an atypical depression, a treatment resistant depression, a bulimia nervosa,
  • a medical device herein can be used to treat a wound and/or accelerate wound healing.
  • a wound can be a surgical wound.
  • a wound can be a wound from a battlefield or from an accident such as a car accident.
  • a medical device can be used to increase wound healing speed, for example for those who have surgery as compared to a wound not exposed to a medical device.
  • a biophoton therapy can be used to treat a stroke.
  • a stroke is a chronic stroke.
  • a stroke is an acute stroke.
  • a stroke can comprise a ischemic stroke, a hemorrhagic stroke, a transient ischemic attack (e.g., a mini stroke), a brain stem stroke, a cryptogenic stroke, or any combination thereof.
  • biophoton therapy disclosed herein can be used to treat a paralysis (e.g., paralysis after a stroke).
  • a biophoton therapy can be used to treat a stroke or a stroke-paralysis.
  • biophoton therapy disclosed herein can be used to treat a dementia.
  • a dementia can comprise an Alzheimer's disease, a vascular dementia, a Lewy Body disease, a frontotemporal dementia, an alcohol related dementia, an HIV associated dementia, a chronic traumatic encephalopathy (CTE) dementia, a childhood dementia, a mixed dementia, or any combination thereof.
  • CTE chronic traumatic encephalopathy
  • biophoton therapy disclosed herein can be used to treat an Alzheimer’s disease, a dementia pugilistica, traumatic brain injury, a Parkinson’s disease, or any combination thereof.
  • a biophoton therapy can be used to reverse the loss of a cognitive ability such as the loss of a cognitive ability due to a dementia.
  • the reverse of the loss of cognitive ability is measured using the integrated Alzheimer’s questionnaire (AQ).
  • improvement in cognitive ability can comprise an AQ score of about 15 points, about 14 points about 13 points, about 12 points, about 11 points, about 10 points, about 9 points, about 8 points, about 7 points, about 6 points, about 5 points, about 4 points, about 3 points, about 2 points, about 1 point or less.
  • the biophoton therapy can decrease an AQ score by at least 1 point, at least 2 points, at least 3 points, at least 4 points, at least 5 points, at least 6 points, at least 7 points, at least 8 points, at least 9 points, at least 10 points, at least 11 points, at least 12 points, at least 13 points, at least 14 points, at least 15 points, at least 16 points, at least 17 points, at least 18 points, at least 19 points, or at least 20 points as compared to the AQ score of a subject prior to biophoton therapy.
  • the biophoton therapy disclosed herein can result in an AQ score of 4 points or less.
  • the biophoton therapy as disclosed here can reduce an AQ score of 20 or more.
  • a biophoton therapy can result in an increase in MoCA scores.
  • the biophoton therapy can increase an MoCA score by at least 1 point, at least 2 points, at least 3 points, at least 4 points, at least 5 points, at least 6 points, at least 7 points, at least 8 points, at least 9 points, at least 10 points, at least 11 points, at least 12 points, at least 13 points, at least 14 points, at least 15 points, at least 16 points, at least 17 points, at least 18 points, at least 19 points, at least 20 points, at least 21 points, at least 22 points, at least 23 points, at least 24 points, at least 25 points, at least 26 points, at least 27 points, at least 28 points, at least 29 points, or 30 points as compared to the MoCA score of a subject prior to biophoton therapy.
  • a biophoton therapy can be used to substantially stop the loss of a cognitive ability such as the loss of a cognitive ability due to a dementia.
  • biophoton therapy disclosed herein can be used to treat a multiple sclerosis.
  • a biophoton therapy can be used to promote brain cell function.
  • a biophoton therapy can be used to increase the quality of life as measured using the standard Short Form Health Survey-36 (SF-36) score.
  • SF-36 Short Form Health Survey-36
  • a low SF-36 score indicates a low quality of life.
  • a higher SF-36 score indicates a high quality of life.
  • a biophoton therapy can increase an SF-36 score by 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%. 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, 99%, or about 100% as compared to the SF-36 score of a subject prior to biophoton therapy.
  • a biophoton therapy can be used to improve brain injury status as measured by electroencephalography (EEG).
  • EEG electroencephalography
  • the biophoton therapy can decrease eyes open: posterior peak frequency score as measured by EEG.
  • the eyes open posterior peak frequency score decreases by 1%, 2%, 3%, 4%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, 99%, or about 100% as compared to the score of a subject prior to biophoton therapy.
  • the biophoton therapy can decrease eyes open: theta/beta ratio as measured by EEG.
  • the eyes open decreases by 1%, 2%, 3%, 4%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, 99%, or about 100% as compared to the score of a subject prior to biophoton therapy.
  • the biophoton therapy can decrease eyes closed: posterior peak frequency score as measured by EEG.
  • a biophoton therapy can decrease evoked potentials (ERPs).
  • the ERPs include, but is not limited to, visual processing, auditory processing, attention/vigilance, and information procession/working memory .
  • the ERPs are reduced from about 1 millisecond (ms) to about 5 ms.
  • a biophoton therapy can decrease reaction time as measured by EEG as compared to a subject prior to receiving biophoton therapy.
  • a biophoton therapy can decrease reaction time variance as measured by EEG as compared to a subject prior to receiving biophoton therapy.
  • a biophoton therapy can decrease missed responses as measured by EEG as compared to a subject prior to receiving biophoton therapy.
  • a biophoton therapy can decrease wrong responses as measured by EEG as compared to a subject prior to receiving biophoton therapy.
  • a biophoton therapy can improve peripheral blood circulation in the left and/or right side of the body as compared to a subject prior to receiving biophoton therapy.
  • the improvement in peripheral blood circulation occurs after 1 week, after 2 weeks, after 3 weeks, after 4 weeks, after 5 weeks, after 6 weeks, after 7 weeks, or after 8 weeks of receiving biophoton therapy .
  • biophoton therapy disclosed herein can be used to treat a cardiac disorder.
  • a cardiac disorder can comprise a coronary heart disease, an angina, an unstable angina, a heart attack, a heart failure, an arrhythmia, a valve disease, a high blood pressure, a congenital heart condition, an inherited heart condition, or any combination thereof.
  • biophoton therapy disclosed herein can be used to treat a hypertension.
  • biophoton therapy disclosed herein can be used to treat a heart disease and/or a heart failure.
  • biophoton therapy disclosed herein can be used to treat a liver disease. In some cases, biophoton therapy disclosed herein can be used to treat a cirrhosis and/or a hepatitis. In some cases, biophoton therapy disclosed herein can be used to treat a kidney deficiency. In some cases, biophoton therapy disclosed herein can be used to treat a kidney disease.
  • a kidney disease can comprise a glomerulonephritis, a kidney stone, a kidney failure, a urinary 7 tract infection, a lupus, a polycystic kidney disease, an Alport syndrome, an ectopic kidney, a Fabry 7 disease, an analgesic nephropathy, a kidney cancer, a nephronophthisis, a vasculitis, an acute tubular necrosis, an APOL1 -related nephropathy, a hemolytic uremic syndrome, an inherited FSGS syndromes, an interstitial nephritis, a kidney cyst, or any combination thereof.
  • biophoton therapy disclosed herein can be used to treat a diabetes.
  • a diabetes can be a ty pe 1 diabetes or a type 2 diabetes.
  • biophoton therapy disclosed herein can be used to treat diseases and conditions such a viral disease, a bacterial disease, a parasitic disease, or any combination thereof.
  • a viral disease is a SARS infection such as SARS-CoV-2, an influenza infection, a rhinovirus infection, or any combination thereof.
  • a medical device can be used to increase an immune response.
  • a biophoton therapy can be used to treat a long coronavirus disease 2019 (COVID-19), a COVID-19 disease, a Coronavirus disease, or any combination thereof.
  • a biophoton therapy herein can be used to treat an autoimmune disorder.
  • a biophoton therapy can be used to treat a Lyme disease.
  • biophoton therapy disclosed herein can be used to treat an anemia.
  • an anemia can be due to chemotherapy and/or radiotherapy.
  • a biophoton therapy herein can alter a skin temperature, a blood oxygen level, or both.
  • a biophoton therapy herein can increase a skin temperature of a subject, increase a blood oxygen level of a subject (as measured by a pulse-oximeter), or both.
  • biophoton therapy disclosed herein can be used to treat a gynecological dysmenorrhea, a premenstrual syndrome (PMS), an infertility, or any combination thereof.
  • a biophoton therapy disclosed herein can be used to treat a male disease, such as a prostate enlargement, an erectile dysfunction, or any combination thereof.
  • biophoton therapy disclosed herein can be used to treat a seizure disorder.
  • a seizure disorder can comprise an epilepsy, a tonic seizure, an atonic seizure, a myoclonic seizure, a clonic seizure, a generalized seizure, a focal seizure, a temporal lobe epilepsy, a Dravet syndrome, or any combination thereof.
  • biophoton therapy disclosed herein can be used to improve bone health, for example in a subject who has an osteoporosis.
  • a biophoton therapy can be used to treat an osteoporosis.
  • a biophoton therapy can be used to treat a hip dysplasia.
  • a biophoton therapy can be used to improve cellular activities of cerebral arteries, improve cellular activities of a neck vein, improve cellular activities of a retina, improve cellular activities of a major organ, improve cellular activities of a pancreas, improve cellular activities of a spleen, improve cellular activities of a kidney, improve cellular activities of an intestine, or any combination thereof.
  • the improvement can be compared against cellular activities of a cell, organ, or biological tissue that was not exposed to a biophoton therapy.
  • a biophoton therapy can be used to reduce ageing in a subject, reduce the occurrence or wrinkles, blemishes or both.
  • a biophoton therapy can be used to treat an acne, a folliculitis, an acne scars, an aging skin, a blemish, a broken blood vessel, a brown spots, a discolored skin, a crease, a deflated or sinking (e.g., around cheeks, temples, lips and eyes), a dull skin, a discolored skin, a fatigued appearance, a tired appearance, a fine line, a fine crease, a flaking skin, a cracking skin, a flushed appearance, a freckle, a furrow, a or a crinkle, a skin rash, a hirsutism, a hypertrichosis, a hyperpigmentation, a rosacea, a sagging or loss of volume, a scar
  • a biophoton therapy can be used to treat an eye disorder.
  • the eye disorder can be glaucoma.
  • a glaucoma can comprise a tension glaucoma, a congenital glaucoma, a pigmentary glaucoma, a primary glaucoma, an open-angle glaucoma, a normal-tension glaucoma, an angle-closure glaucoma, a neovascular glaucoma, an exfoliation glaucoma, a uveitic glaucoma, or any combination thereof.
  • a biophoton therapy can improve a retina.
  • the improved retina can increase visual function, and blood circulation in an eye.
  • a biophoton therapy can be used to treat a mitochondrial deficiency.
  • a biophoton therapy can be used to treat a mitochondrial disease.
  • a mitochondrial disease can comprise a mitochondrial encephalopathy, a lactic acidosis and strokelike episodes (MELAS) syndrome, a Leber hereditary optic neuropathy, a Leigh syndrome, a Kearns-Sayre syndrome, a Myoclonic epilepsy and ragged-red fiber disease, an Alpers syndrome, a Pearson syndrome, a mitochondrial cardiomyopathy, a Barth syndrome, a lactic acidosis, or any combination thereof.
  • MELAS lactic acidosis and strokelike episodes
  • a biophoton therapy can be used to treat an asthma, a Chronic Obstructive Pulmonary Disease (COPD), a respiratory disease, or any combination thereof.
  • COPD Chronic Obstructive Pulmonary Disease
  • a treatment of a respiratory disease can comprise an increase in breathing capacity after treatment as compared to the breathing capacity before a treatment.
  • a biophoton therapy can be used to treat a tinnitus.
  • a biophoton therapy can be used to treat a genetic disease.
  • a biophoton therapy can be used to treat a neuromuscular disease.
  • a biophoton therapy can be used to treat a gastrointestinal disorder.
  • a gastrointestinal disorder can comprise an irritable bowel syndrome, an ulcerative colitis, a Celiac disease, a constipation, an ulcer, a hemorrhoids, a diarrhea, a diverticulitis, a dyspepsia, an anal fissures, a bowel obstruction, a colon cancer, a gallstone, a gastroententis, a nausea, a pancreatitis, a bowel incontinence, a colorectal polyp, a gastric neoplasm, a gastritis, a short bowel syndrome, or any combination thereof.
  • a biophoton therapy can be used to treat a taste or smell disorder, a cough, a chest pain, a hearing problem (e.g., hearing loss or ringing in the ears), a shortness of breath, a hair loss, a sleep disorder, a bladder disorder, including difficulty urinating or incontinence, a vision problem (such as blurry 7 vision, sensitivity to light, floaters, flashing lights, or difficulty reading or focusing eyes) a swelling of the legs, a problem with teeth, a foot pain, a change in menstrual cycle, or any combination thereof.
  • a vision problem such as blurry 7 vision, sensitivity to light, floaters, flashing lights, or difficulty reading or focusing eyes
  • a bladder disorder can comprise a bedwetting, a cystitis, a bladder stone, an overactive bladder, a paruresis, an urinary incontinence, a cystocele, a bladder polyp, a bladder cancer, or any combination thereof.
  • a biophoton therapy can be used to treat a thyroid disorder.
  • a thyroid disorder can comprise hyperthyroidism, hypothyroidism, or any combination thereof.
  • a medical device can be used to balance a hormone level, for example in a subject who has a hyperthyroid or hypothyroid function.
  • a biophoton therapy can be used to treat a Cushing's disease.
  • a biophoton therapy can be used to treat an endocrine disorder.
  • a biophoton therapy can be used to treat delayed growth of a subject (e.g., a short stature), a delayed puberty 7 , or both.
  • a biophoton therapy can be used to induce body growth (e.g., for a child who has a delayed grow th).
  • a medical device can be used to increase the metabolism of a human.
  • a medical device can be used to treat a cancer.
  • a cancer can be a terminal cancer.
  • a cancer can comprise a stage 1 cancer, a stage 2 cancer, a stage 3 cancer, or a stage 4 cancer.
  • a cancer can comprise a lung cancer, a colon cancer, a leukemia, a prostate cancer, a bone cancer, a breast cancer, a brain tumor, a pancreatic cancer, a stomach cancer, an ovary cancer, a uterus cancer, or any combination thereof.
  • treatment of a cancer can comprise reducing the size of a tumor, stopping the growth of a tumor, stopping the spread of a tumor, reduce side effects or toxicity of a chemotherapy or radiotherapy of a cancer, or any combination thereof.
  • a biophoton therapy can be used to treat a lymphedema.
  • a cancer can comprise an acute lymphoblastic leukemia (ALL), an acute myeloid leukemia (AML), an adolescent cancer, an adrenocortical carcinoma, an AIDS-related cancers, an AIDS-related lymphoma (e.g., a lymphoma), a primary CNS lymphoma (e g., a lymphoma), an anal cancer, an appendix cancer, an astrocytoma (e.g., a brain cancer), an atypical teratoid, a rhabdoid tumor, a central nervous system cancer (e.g.
  • ALL acute lymphoblastic leukemia
  • AML acute myeloid leukemia
  • adolescent cancer an adrenocortical carcinoma
  • an AIDS-related cancers e.g., a lymphoma
  • a primary CNS lymphoma e.g., a lymphoma
  • an anal cancer e
  • a basal cell carcinoma of the skin a bile duct cancer, a bladder cancer, a bone cancer (including an Ewing sarcoma and an osteosarcoma and an malignant fibrous histiocytoma), a sarcoma, a bronchial tumor (e.g., lung cancer), a Burkitt lymphoma, a carcinoma, an aty pical teratoid, a rhabdoid tumor (e.g., brain cancer), an medulloblastoma and other CNS embryonal tumors, a germ cell tumor, a primary CNS lymphoma, a cervical cancer, a childhood cancer, a cancer of childhood (e.g., rare), a cholangiocarcinoma, Chordoma (e.g., bone cancer, a chronic lymphocytic leukemia (CLL), a chronic myelogenous leukemia (CML), a chronic myeloproliferative neoplasm
  • an Ewing sarcoma e.g., bone cancer
  • an extracranial germ cell tumor e.g., an extragonadal germ cell tumor, an eye cancer, an intraocular melanoma, a retinoblastoma, a fallopian tube cancer, a gallbladder cancer, a gastric (stomach) cancer, gastrointestinal neuroendocrine tumors, gastrointestinal stromal tumors (GIST) (e.g., soft tissue sarcoma), a germ cell tumor, a childhood central nervous system germ cell tumors, an extracranial germ cell tumors, an extragonadal germ cell tumor, an ovarian germ cell tumor, a testicular cancer, a gestational trophoblastic disease, an hairy cell leukemia, a head and neck cancer, heart tumors, a hepatocellular (liver) cancer, an histiocytosis (e.g., langerhans cell), a Hodgkin lymphoma, a hypo
  • AML myeloid leukemia
  • myeloproliferative neoplasms e.g., chronic
  • a nasal cavity and paranasal sinus cancer a nasopharyngeal cancer, a neuroblastoma, neuroendocrine tumors, a non-Hodgkin lymphoma, anon-small cell lung cancer, an oral cancer, a lip and oral cavity cancer and oropharyngeal cancer, a osteosarcoma and undifferentiated pleomorphic sarcoma of bone treatment, an ovarian cancer, a pancreatic cancer, pancreatic neuroendocrine tumors (e.g., an islet cell tumor), a papillomatosis (e.g., laryngeal), a paraganglioma, a paranasal sinus and nasal cavity cancer, a parathyroid cancer, a penile cancer, a phary ngeal cancer, a p
  • cutaneous a testicular cancer, a throat cancer (e.g., head and neck cancer), a nasopharyngeal cancer, an oropharyngeal cancer, a hypopharyngeal cancer, a thymoma and thymic carcinoma, a thyroid cancer, tracheobronchial tumors (e.g., lung cancer), a transitional cell cancer of the renal pelvis and ureter (e.g., kidney cancer), an unknown primary, a ureter and renal pelvis (e g., transitional cell cancer), a urethral cancer, a uterine cancer (e.g..).
  • a uterine sarcoma a vaginal cancer
  • a vascular tumor a vascular tumor
  • a vulvar cancer a Wilms tumor (e.g., kidney tumors), a cancer in young adults, or any combination thereof.
  • a biophoton therapy can be used to stimulate a biological process.
  • biophoton therapy can be used to simulate increased fermentation of a microbial sy stem/ culture, induce accelerated plant growth, increase cellular production of a biological material, promote growth of an animal, among other things.
  • biophoton therapy can be used to increase the rate of fermentation, for example fermentation of an alcohol.
  • a fermentation can be in a fermentation tank.
  • the rate of fermentation by yeast e.g., Saccharomyces cerevisiae
  • the rate of a fermentation after or during biophoton therapy can be increased by at least about: 2%. 3%, 4%, 5%, 10%, 15%, 20%. 25%. 30%. 35%. 40%. 45%. 50%. 55%. 60%. 65%. 70%. 75%. 80%. 85%. 90%. 95%. or 100% as compared to a fermentation that is not administered a biophoton therapy.
  • the yield of a fermentation can be increased by a biophoton therapy.
  • the yield of fermentation after or during biophoton therapy can be increased by at least about: 2%, 3%, 4%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100% as compared to a fermentation that is not administered a biophoton therapy.
  • administration of a biophoton therapy can be used to increase biological processes, for example administration of biophotons can increase the rate of protein production and/or molecule production from a cell.
  • the rate of a protein production from a cell after or during biophoton therapy can be increased by at least about: 2%, 3%, 4%, 5%, 10%, 15%. 20%. 25%. 30%. 35%. 40%. 45%. 50%. 55%. 60%, 65%, 70%, 75%, 80%. 85%. 90%. 95%. or 100% as compared to a protein production from a cell that is not administered a biophoton therapy.
  • the rate of a compound produced from a cell after or during biophoton therapy can be increased by at least about: 2%, 3%, 4%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100% as compared to a compound produced from a cell that is not administered a biophoton therapy.
  • administration of a biophoton therapy can increase the rate of therapeutic protein production by a cell.
  • the rate of antibody production by a cell can be increased by biophoton administration to the cell.
  • the yield of a protein and/or compound production by a cell can be increased by a biophoton therapy.
  • the yield of a protein and/or compound from a cell after or during biophoton therapy can be increased by at least about: 2%, 3%, 4%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100% as compared to a yield of a protein and/or compound from a cell that is not administered a biophoton therapy.
  • a medical device can be used to infuse a water, a beverage, a soda, and/or juices with biophotons.
  • a water or a beverage can be energized with biophotons produced by a medical device.
  • the biophotons can remain in the water and be administered by drinking a water or a beverage or by contacting a subject with the water.
  • a beverage can comprise an alcoholic beverage (e.g., a wine, a beer, or a liquor).
  • a beverage can comprise a juice, a soft drink, or any beverage.
  • a biophoton therapy can be used to increase the aging process/speed of a wine, liquor, or other beverage.
  • a biophoton therapy can be used to promote the grow th of an animal, such as a farm animal.
  • a farm animal can comprise chickens, ducks, pigs, sheep, cows, and/or horses.
  • biophoton therapy can be used to increase the weight of an animal.
  • the weight of an animal after or during biophoton therapy can be increased by at least about: 2%, 3%, 4%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100% as compared to the weight of an animal that is not administered a biophoton therapy.
  • a medical device can be used to enhance the growth of an animal, increase the production of a product (e.g., eggs) as compared to an animal not exposed to a medical device.
  • a product e.g., eggs
  • the egg production from an animal after or during biophoton therapy can be increased by at least about: 2%, 3%, 4%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%. 55%. 60%. 65%. 70%. 75%. 80%. 85%. 90%, 95%, or 100% as compared to the egg production from an animal that is not administered a biophoton therapy.
  • a medical device can be used to increase the speed of growth, the yield, the shelf life, the nutritional value, or any combination thereof, of an agriculture product such as a fruit or a vegetable as compared to an agriculture product not exposed to a medical device.
  • the growth rate of a plant after or during biophoton therapy can be increased by at least about: 2%, 3%, 4%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100% as compared to a growth grate of a plant that is not administered a biophoton therapy.
  • the yield of a crop of a plant can be increased by a biophoton therapy.
  • the yield of a crop of a plant after or during biophoton therapy can be increased by at least about: 2%, 3%, 4%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100% as compared to a yield of a crop of a plant that is not administered a biophoton therapy.
  • a medical device as disclosed herein can be used to administer biophotons to a subject.
  • the administration of biophotons to a subject is referred to herein a biophoton therapy.
  • Biophoton therapy can be administered to a subject by placing a medical device near the subject.
  • a medical device can be placed under a bed, next to a bed, on a nightstand, on or under a table, under a chair, packed in a backpack, or in any location that is in proximity to the subject.
  • a subject can be within in a range of about: 0.1 meter to about 20 meters, 0.1 meters to about 1 meter, 0.5 meters to about 3 meters, 0.1 meters to about 10 meters. 0.5 meters to about 10 meters, 1 meter to about 10 meters, 0.5 meter to 5 meters, 2 meters to 8 meters, 5 meters to about 15 meters or about 10 meters to about 20 meters to a medical device.
  • a subject can be at a distance of more than, less than, or equal to about: 0.1 meters, 0.2 meters, 0.3 meters, 0.4 meters, 0.5 meters, 0.6 meters. 0.7 meters. 0.8 meters. 0.9 meters. 1 meters.
  • the biophotons can be active on direct contact with a subject, for example if a subject is touching a medical device.
  • a biophoton therapy can be administered as needed, or for: one day, two days, three days, four days, five days, six days, a week, two weeks, three weeks, a month, two months, three months, four months, five months, six months, seven months, eight months, nine months, ten months, eleven months, a year, two years, or chronically.
  • a biophoton therapy can be administered continuously or intermittently for a total exposure of about: 5 minutes to about 24 hours, 5 minutes to about 60 minutes, 10 minutes to about 30 minutes, 5 minutes to about 20 minutes, 15 minutes to about 30 minutes, 20 minutes to about 40 minutes, 40 minutes to about 60 minutes, 30 minutes to about 60 minutes, 1 hour to about 1.5 hours, 1 hour to about 2 hours, 2 hours to about 4 hours, 3 hours to about 6 hours, 5 hours to about 10 hours, 7 hours to about 12 hours, 8 hours to about 16 hours, 12 hours to about 24 hours, or about 24 hours to about 48 hours per dose.
  • a biophoton therapy can be administered continuously or intermittently for a total exposure of more than, less than, or equal to about: 1 min, 2 min, 3 min, 4 min, 5 min, 6 min, 7 min, 8 min, 9 min, 10 min, 11 min, 12 min, 13 min, 14 min, 15 min, 16 min, 17 min, 18 min, 19 min, 20 min,
  • a biophoton therapy can be administered continuously or intermittently for a total exposure of more than, less than, or equal to about: 1 hour, 2 hours, 3 hours. 4 hours, 5 hours. 6 hours, 7 hours. 8 hours, 9 hours, 10 hours, 11 hours, 12 hours. 13 hours. 14 hours.
  • a biophoton therapy can be administered in about: 1 dose, 2 doses, 3 doses, 4 doses, 5 doses, 6 doses, 7 doses, 8 doses, 9 doses, 10 doses, or more than 10 doses.
  • administering of biophoton therapy can be performed at least about: 1 time per day, 2 times per day, 3 times per day, 4 times per day, 5 times per day, 6 times per day, 7 times per day, 8 times per day, 9 times per day, or more than 9 times per day.
  • administration of a biophoton therapy can be performed at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, or 24 times in a 24-hour period.
  • administration of a biophoton therapy can be performed at least: 1, 2, 3, 4, 5, 6, 7, 8. 9, 10, 11, 12, 13, 14. 15. 16. 17. 18. 19, 20, or 21 times a week.
  • administration of a biophoton therapy can be performed at least: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,
  • administering can be performed daily, weekly, monthly, or as needed.
  • administration can be performed by a subject (e.g., the patient), a health care provider, or both.
  • administering of biophoton therapy can be performed for a treatment duration of at least about, or equal to: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42,
  • a treatment duration of a biophoton therapy can be from about 1 to about 30 days, from about 10 to about 30 days, from about 25 to about 60 days, from about 45 to about 90 days, from about 100 to about 300 days, from about 200 to about 500 days, or from about 250 days to about 1000 days.
  • administering of biophoton therapy can be performed for a treatment duration of at least about 1 day, at least about 1 week, at least about 1 month, at least about 1 year, at least about 2 years, at least about 3 years, at least about 4 years, at least about 5 years, at least about 6 years, at least about 7 years, at least about 8 years, at least about 9 years, at least about 10 years, at least about 15 years, at least about 20 years, or for life.
  • Administration can be performed repeatedly over a lifetime of a subject, such as once a day, once a week, once a month or once a year for the lifetime of a subject.
  • a biophoton therapy can be administered with 1 or more medical devices.
  • a biophoton therapy can be administered with about: 1 medical device to about 100 medical devices, 1 medical device to about 20 medical devices, 1 medical device to about 5 medical devices, 5 medical devices to about 15 medical devices, 1 medical device to about 10 medical devices, 10 medical devices to about 25 medical devices, 20 medical devices to about 50 medical devices, 30 medical devices to about 60 medical devices, 50 medical devices to about 80 medical devices, 60 medical devices to about 90 medical devices, or about 80 medical devices to about 100 medical devices.
  • a biophoton therapy can be administered with at least about: 1, 2, 3, 4, 5, 6, 7. 8, 9, 10, 11, 12, 13, 14, 15, 16, 17. 18. 19, 20, 21, 22, 23, 24, 25.
  • administering a biophoton therapy herein can comprise administering an amount sufficient to treat a disease, condition, and/or symptom.
  • administering a biophoton therapy herein can comprise administering a range of about: 1 million to about 40 million biophotons, 1 million to about 10 million biophotons, 5 million to about 15 million biophotons, 10 million to about 20 million biophotons, 15 million to about 25 million biophotons, 20 million to about 30 million biophotons, 25 million to about 35 million biophotons, or about 30 million to about 40 million biophotons in 600 pm 2 /sec as measured by a MIRA camera.
  • administering a biophoton therapy herein can comprise administering more than about, less than about, or equal to about: 1 million biophotons, 2 million biophotons, 3 million biophotons, 4 million biophotons, 5 million biophotons, 6 million biophotons, 7 million biophotons, 8 million biophotons, 9 million biophotons, 10 million biophotons, 11 million biophotons, 12 million biophotons, 13 million biophotons, 14 million biophotons, 15 million biophotons, 16 million biophotons, 17 million biophotons, 18 million biophotons, 19 million biophotons, 20 million biophotons, 21 million biophotons, 22 million biophotons, 23 million biophotons, 24 million biophotons, 25 million biophotons, 26 million biophotons, 27 million biophotons, 28 million biophotons, 29 million biophotons, 30 million biophotons, 31 million biophotons, 32 million biophotons,
  • a biophoton therapy can be administered when the subject is awake, or sleeping. In some cases, a biophoton therapy can be administered when the subject is stationary, for example at work.
  • a medical device can be placed under or near the bed of a subject. In some cases, a medical device can be placed at any location that is near the subject, for example on a desk, in backpack of a subject, or under a chair of a subject.
  • a medical device disclosed herein can be comprised in a kit.
  • the materials for a medical device e.g., a stone, a polymer, a metal, a sand, a water and/or an unactivated ingredient
  • the materials are comprised in a kit individually or in combination.
  • a kit can comprise a container.
  • a container can be any container such as a glass container, a metal container, a plastic container, a wood container, or any combination thereof.
  • Embodiment 1 A method of treating a stroke in a subject in need thereof, the method comprising placing a medical device within about 0. 1 meters to about 5 meters from a subject for at least about 1 hour per day, wherein the medical device comprises a substantially heterogeneous mixture of: (a) a stone selected from the group consisting of: a diamond, an amethyst, a tourmaline, a jade, an obsidian, and any combination thereof: (b) a sand comprising at least about 95% silicon dioxide by weight; (c) a metal selected from the group consisting of: a copper, an iron, and any combination thereof; (d) a polymer selected from the group consisting of: an isoprene rubber, a butyl rubber, a cellulose, a polysaccharide, or any combination thereof; (e) a water; and (d) a supporting material selected from the group consisting of: a grout, a modified sulfur cement, an agar, and any combination thereof; where
  • Embodiment 2 The method of embodiment 1, wherein the supporting material is the grout.
  • Embodiment 3 The method of embodiment 1, wherein the weight to weight ratio of the stone, the sand, the metal, the polymer, the w ater and the supporting material is about 10% the stone: 10% the sand: 10% the metal: 50% the polymer: 10% the water: and about 10% the supporting material.
  • Embodiment 4 The method of embodiment 1, wherein the stone is the diamond.
  • Embodiment 5 The method of embodiment 1, wherein the stone is the amethyst.
  • Embodiment 6 The method of embodiment 1 , w herein the stone is the tourmaline.
  • Embodiment 7 The method of embodiment 1. wherein the stone is the jade.
  • Embodiment 8 The method of embodiment 1. wherein the stone is the obsidian.
  • Embodiment 9 The method of embodiment 1, wherein the metal is the copper.
  • Embodiment 10 The method of embodiment 1, wherein the metal is the iron.
  • Embodiment 11 The method of embodiment 1, wherein the polymer is the isoprene rubber.
  • Embodiment 12 The method of embodiment 1, wherein the polymer is the butyl rubber.
  • Embodiment 13 The method of embodiment 1, wherein the polymer is the cellulose and comprises an alpha cellulose or a salt thereof.
  • Embodiment 14 The method of embodiment 1, wherein the polymer is the polysaccharide and comprises a hyaluronic acid or a salt thereof.
  • Embodiment 15 The method of embodiment 1, wherein the supporting material is the modified sulfur cement.
  • Embodiment 16 The method of embodiment 1 , wherein the medical device is placed within about 0.1 meters to about 5 meters from the subject for at least about 8 hours per day for at least 1 week.
  • Embodiment 17 The method of embodiment 1, wherein the subject in need thereof has an increase in their Stroke Impact Scale (SIS) score after about 1 week of treatment as compared to a subject who w as not within about 0.1 meters to about 5 meters from the medical device for at least about 1 hour per day.
  • SIS Stroke Impact Scale
  • Embodiment 18 The method of embodiment 1, wherein the subject in need thereof has an increase in their SF-36 score after about 1 week of treatment as compared to a subject who was not within about 0.1 meters to about 5 meters from the medical device for at least about 1 hour per day.
  • Embodiment 19 The method of embodiment 1, wherein the subject in need thereof has an increase in their stroke recovery rate score after about 1 week of treatment as compared to a subject who was not within about 0. 1 meters to about 5 meters from the medical device for at least about 1 hour per day.
  • Embodiment 20 The method of embodiment 1, wherein the substantially heterogeneous mixture is a solid mixture.
  • Embodiment 1 A medical device, wherein the medical device comprises a substantially heterogeneous mixture of: (a) a stone selected from the group consisting of: a diamond, an amethyst, a tourmaline, a jade, an obsidian, and any combination thereof; (b) a sand comprising at least about 95% silicon dioxide by weight; (c) a metal selected from the group consisting of: a copper, an iron, and any combination thereof; (d) a polymer selected from the group consisting of: an isoprene rubber, a butyl rubber, a cellulose, a polysaccharide, or any combination thereof; (e) a water: and (d) a supporting material selected from the group consisting of: a grout, a modified sulfur cement, an agar, and any combination thereof; wherein the stone, the sand, the metal, and the polymer comprise particles that each comprise a particle size diameter ranging from about 0. 1 mm to about 5 mm; wherein
  • Embodiment 2 The medical device of embodiment 1, wherein the supporting material is the grout.
  • Embodiment 3 The medical device of embodiment 1, wherein a weight to weight ratio of the stone, the sand, the metal, the polymer, the water and the supporting material is about: 10% the stone. 10% the sand, 10% the metal, 50% the polymer. 10% the water, and 10% the supporting material.
  • Embodiment 4 The medical device of embodiment 1 , wherein the stone is the tourmaline.
  • Embodiment 5 The medical device of embodiment 1. wherein the stone is the diamond.
  • Embodiment 6 The medical device of embodiment 1 , wherein the stone is the amethyst.
  • Embodiment 7 The medical device of embodiment 1, wherein the stone is the jade.
  • Embodiment 8 The medical device of embodiment 1, wherein the stone is the obsidian.
  • Embodiment 9 The medical device of embodiment 1. wherein the metal is the copper.
  • Embodiment 10 The medical device of embodiment 1, wherein the metal is the iron.
  • Embodiment 11 The medical device of embodiment 1, wherein the polymer is the isoprene rubber.
  • Embodiment 12 The medical device of embodiment 1, wherein the polymer is the buty l rubber.
  • Embodiment 13 The medical device of embodiment 1, wherein the polymer is the cellulose and comprises an alpha cellulose or a salt thereof.
  • Embodiment 14 The medical device of embodiment 1, wherein the polymer is the polysaccharide and comprises a hyaluronic acid or a salt thereof.
  • Embodiment 15 The medical device of embodiment 1, wherein the polymer is the cellulose and comprises an alpha cellulose or a salt thereof.
  • Embodiment 16 The medical device of embodiment 1, wherein the polymer is the polysaccharide and comprises a hyaluronic acid or a salt thereof.
  • Embodiment 17 The medical device of embodiment 1, wherein the supporting material is the modified sulfur cement.
  • Embodiment 18 The medical device of embodiment 1, wherein the supporting material is the agar.
  • Embodiment 19 The medical device of embodiment 1, wherein the sand comprises at least about 98% silicon dioxide.
  • Embodiment 20 The medical device of embodiment 1, wherein the substantially heterogeneous mixture is a solid mixture.
  • the first device was an early medical device that comprised: copper powder
  • the second device was an updated device that comprised: fine isoprene rubber powder - 250 grams, copper powder - 50 grams, tourmaline powder - 50 grams, sand comprising silicon dioxide - 50 grams, water - 50 grams, grout - 50 grams, for a total weight of 500 grams.
  • the particle sizes of the copper powder, tourmaline powder, sand, and isoprene rubber were with the range of 0.1 mm to 5 mm in diameter.
  • FIG. 1A shows Device A released about 7 million biophotons in 600 pm 2 /sec as measured by a MIRA camera.
  • FIG. IB shows Device B released about 8 million biophotons in 600 gm 2 /sec as measured by a MIRA camera. This data was reproducible in independent replicates.
  • the multispectral video camera counts the number of biophotons per second released from a 600 x 600 [im window. Overall, for the exemplified experiments there was a total biophoton emission of about 130,000,000 biophotons from Device A and about 140,000,000 biophotons from Device B for the recorded session.
  • the data shows the updated medical device (Device B) with added isoprene rubber powder surprisingly and unexpectedly produced more biophotons than the original medical device.
  • the medical devices that were tested were a medical device that comprised a single stone and a medical device that comprised a mix of materials.
  • the medical device that comprised a single stone comprised: tourmaline powder - 300 grams, sand comprising silicon dioxide - 100 grams, water - 50 grams, grout - 50 grams, for a total mixture weight of 500 grams.
  • the medical device that comprised a mix of materials comprised: tourmaline powder - 200 grams, isoprene rubber powder - 100 grams, copper powder - 50 grams, sand comprising silicon dioxide 50 grams, water 50 grams, grout 50 grams, total 500 grams.
  • the particle sizes of the copper powder, tourmaline powder, sand, and isoprene rubber were within the range of 0.1 mm to 5 mm in diameter.
  • the device that contained a mix of materials produced more biophotons than the device with a single stone as shown in FIG. 2.
  • the device comprising a mix of materials produced 12x more biophotons as compared to the device with a single stone.
  • the biophotons were measured by a single photon detector produced by Thorlabs. The intensity of biophotons over 30 minutes was measured for each product. The measurement was reproducible in independent replicates.
  • the Y-axis indicates the intensity (strength) of the biophoton signal and the X-axis indicates the time in minutes.
  • Table 1 Patient demographic for stroke study
  • the treatment comprised administration of biophoton therapy w ith a medical device.
  • medical devices w ere placed under the bed of the patients with chronic stroke.
  • the treated subjects w ere each exposed to a group of 14 medical devices each w eighing 2.5 kg.
  • the medical devices comprised rubber isoprene powder - 1250 grams, copper powder - 250 grams, tourmaline pow der - 250 grams, sand comprising silicon dioxide - 250 grams, water - 250 grams, grout - 250 grams for a total weight of 2500 grams.
  • the placebo (control) group were each exposed to a group of 14 placebo devices each weighing 2.5 kg.
  • the placebo device comprised sand comprising silicon dioxide - 2000 grams, water - 250 grams, grout - 250 grams for a total of 2500 grams.
  • the placebo device emitted a much lower amount of biophotons as compared to the treatment medical device.
  • the particle sizes of the copper powder, tourmaline powder, sand, and isoprene rubber powder were within the range of 0. 1 mm to 5 mm in diameter.
  • the patients in the treatment group were exposed to the devices at a distance of about 40 centimeters for a time ranging from a minimum 8 hours to a maximum of 24 hours per day.
  • the patients in the control group were exposed to the placebo devices at a distance of about 40 centimeters for a time ranging from a minimum of 8 hours to a maximum of 24 hours per day.
  • the active devices were used for the entire 4 weeks for these patients in the Treatment group. Therefore, these patients were also actively treated for 4 weeks.
  • the placebo devices were used for the first two weeks of the study but were switched to the active biophoton therapy after the first two weeks of placebo treatment. Therefore, these patients were also actively treated for 4 weeks, to be ethically justified.
  • the Stroke Impact Scale (SIS) of the patients in the treatment group increased significantly as compared to the control group (see FIG. 3).
  • the SIS is an internationally used standard research tool to monitor the disease and function status of stroke.
  • the SIS has multiple components.
  • scores of SIS were obtained weekly by the clinical study team staffer, from the study participant or his/her caregiver.
  • the Y-Axis shows the percentages of the increased SIS as compared to the baseline, the X-axis shows the length of time of the study.
  • the scores for the treatment group were: 1.0 at week 0 (baseline), 1.06 in week 1,
  • the p-values are 0.7758 and 0.7328 at Week 1 and 2 before switching to the treatment. After switching to the treatment, the p-values are 0. 1137, 0.0332, 0.0019, and 0.0079 after being treated for 1 to 4 weeks respectively.
  • the p-value becomes significant after the treatment was started for 2 weeks. It shows that there was no improvement while patients were on the placebo treatment. The numerical improvement shows immediately after the switch and the improvement becomes significant after the subjects were treated for 2 weeks.
  • the p-values are 0.0084, 0.0112, 0.0406, 0.0812. These p-values are for comparing a) 1 week of treatment vs 1 week of placebo; b) 2 weeks of treatment vs 2 w eeks of placebo; c) 3 weeks of treatment vs 2 weeks of placebo + 1 week of treatment; d) 4 weeks of treatment vs 2 weeks of placebo + 2 weeks of treatment, respectively.
  • the change from baseline was statistically significantly between the placebo and the treatment. Although the difference (treated for 3 weeks vs treated for 1 week) was still significant at Week 3, the control group demonstrates numerical improvement. At Week 4, the treatment group still showed improvement compared to the Control, but the difference w as no longer significant.
  • the stroke recovery rate improved in the treatment group after using a medical device improved in the treatment group after using a medical device. Improvement was seen in the first week of the treatment group (score of 1.39) as compared to the control group (score of 1.02) as shown in FIG. 4.
  • the stroke recovery rate was reported by the study participant or caregiver and verified by the study physician.
  • the stroke recovery rate is an individual measurement on the Stroke Impact Scale (SIS) questionnaire. This increase was maintained throughout the length of the study. Once the control group was switched to the biophoton therapy, there was an increase in stroke recovery rate from week 3 to week 6.
  • SIS Stroke Impact Scale
  • the Y-Axis shows the percentage of the stroke recovery rate
  • the X-axis shows the length of time of the study.
  • the control group [171] Comparing the changes from the baseline at each week (weeks 1 to 6), the p-values are 0.6878 and 0.5232 at Week 1 & 2 before switching to the treatment. After switching to the treatment, the p-values are 0.4560, 0.0003, 0.0005, and 0.0003 after being treated for 1 to 4 weeks respectively. The p-value became significant after the treatment started for 2 weeks. The data shows that there is no improvement while patients were on the placebo treatment. Though it is not significant with a p value of 0.4560 at Week 3 (1 week after switching to the active treatment), there was a numerical improvement. The improvement becomes significant 2 weeks after switching from the placebo to the treatment.
  • the p-values are 0.0624, 0.0216, 0.0640, 0.0355. These p-values are for comparing a) 1 w eek of treatment vs 1 week of placebo; b) 2 weeks of treatment vs 2 weeks of placebo; c) 3 w eeks of treatment vs 2 weeks of placebo + 1 week of treatment; d) 4 w eeks of treatment vs 2 weeks of placebo + 2 weeks of treatment.
  • the change from baseline was statistically significantly different between the placebo and the treatment. Although the difference (treated for 3 weeks vs treated for 1 week) was still significant at Week 3, the control group demonstrated numerical improvement. At Week 4, the treatment group showed better improvement comparing to the Control, but the difference w as no longer significant.
  • the neurological exam comprised measuring multiple factors and the total score was summarized by the study physician. The results are shown in FIG. 5.
  • the Y- Axis shows the neurologic exam scores, the X-axis shows the length of time of the study.
  • the scores for the treatment group were: 328 at week 0 (baseline), 341 in week 1, 355 in week 2, 360 in week 3, and 384 in week 4.
  • the scores for the control group were: 323 at week 0 (baseline). 324 in week 1, 333 in week 2, 357 in week 3, 360 in week 4, 368 in week 5, 379 in week 6.
  • the Neurologic Exam Score improved in the treatment group after using a medical device throughout the 4 weeks of the study. Similarly, improvement was seen in the first week of the treatment group (score of 341 - change of 13 points from the baseline) as compared to the control group (score of 324 - change of 1 point from baseline) as shown in FIG. 5. This increase was maintained throughout the length of the study. Once the control group was switched to the biophoton therapy, there was an increase in Neurologic Exam Scores from week 3 to week 6. [179] The life quality of the patients with chronic stroke improved significantly after using medical devices as shown in FIG. 6. To assess the life quality of the patients a SF-36 was administered to the patients in both groups before and during the clinical study.
  • the SF-36 assessment is an internationally used standard research tool to monitor the life quality for many chronic conditions.
  • the total score of the 36 questions was used to calculate the overall SF-36 score.
  • the Y-Axis shows the percentage of the SF-36 score as compared to the baseline, the X-axis shows the length of time of the study.
  • patients in both the Control and Treatment groups did not have any change 4 weeks before participating in the living-in at-center study. Once exposed to the medical device, the treatment group had an immediate increase in the score.
  • the patients in the placebo-control group did not make any meaningful improvement during the first 2 weeks (the placebo phase) as noted by the constant score. After the control group was switched to the treatment (after week 2). their life quality improved.
  • TBI Traumatic Brain Injury
  • the treatment comprises administration of biophoton therapy with a medical device.
  • the treatment group (and control group once switched to treatment after week 2) are exposed to a group of 14 medical devices that each weigh 2.5 kg.
  • the medical devices comprise isoprene rubber powder - 1250 grams, copper powder - 250 grams, tourmaline powder - 250 grams, sand comprising silicon dioxide - 250 grams, water - 250 grams, grout - 250 grams, for a total of 2500 grams.
  • the control subjects are exposed to a group of 14 placebo devices that each weigh 2.5 kg.
  • the placebo devices comprise sand comprising silicon dioxide - 2000 grams, water - 250 grams, grout - 250 grams, for a total weight of 2500 grams.
  • the placebo device emitted a much lower amount of biophotons as compared to the treatment medical device.
  • the particle sizes of the copper powder, tourmaline powder, sand, and isoprene rubber powder were within the range of 0. 1 mm to 5 mm in diameter.
  • the patients in the treatment group are each exposed to 14 devices at a distance of about 40 centimeters for a time ranging from a minimum 8 hours to a maximum of 24 hours per day.
  • the patients in the control group are each exposed to the 14 placebo devices at a distance of about 40 centimeters for a time ranging from a minimum of 8 hours to a maximum of 24 hours per day.
  • the active medical devices are used for the entire 4 weeks for the patients in the treatment group.
  • the placebo devices are used for the first two weeks of the study but are switched to active medical devices after the first two weeks of placebo treatment. Therefore, these patients are also actively treated for 4 weeks, to be ethically justified.
  • a randomized triple blinded placebo controlled clinical study was conducted to verify if biophotons can improve cognition of patients with Alzheimer’s disease (AD).
  • the clinical trial enrolled a total of 30 participants diagnosed with moderate to severe AD. All participants continued their standard care if any.
  • 16 participants in the treatment group individually used a group of 14 medical devices daily.
  • the medical devices each weighted 2.5 kg and comprised isoprene rubber powder - 1250 grams, copper powder - 250 grams, tourmaline powder - 250 grams, sand comprising silicon dioxide - 250 grams, water - 250 grams, grout - 250 grams, for a total weight of 2500 grams.
  • the placebo device emitted a much lower amount of biophotons as compared to the treatment medical device.
  • the particle sizes of the copper powder, tourmaline powder, sand, and isoprene rubber powder were within the range of 0. 1 mm to 5 mm in diameter.
  • Preliminary' outcome cognitive function was assessed by using an Alzheimer Questionnaire, life quality was measured using a SF-36 life quality questionnaire; and electroencephalogram (EEG) measurements were assessed using standardized measurements.
  • Preliminary analysis reveals an improvement in cognitive performance among participants in the biophoton therapy group compared to the control group. Seventy -five percent (75%) of participants had reduced severity of Alzheimer's disease; and 88% had an increased life quality SF-36 score. All were significantly different from the Control group (P ⁇ 0.01) - statistics were completed with a self-comparison ANOVA.
  • the EEG test also showed that the “missed response” was reduced in the Treatment group. In addition, caregivers reduced the stress and difficulty in caring for their seniors. No adverse effects were observ ed.
  • FIG. 7 shows an image of the biophotons of a water bottle before and after being energized with a strong medical device.
  • a bottle of water was exposed for over 24 hours to 4 medical devices each weighing 45 kg.
  • the medical devices comprised isoprene rubber - 22,500 grams, copper powder - 4500 grams, tourmaline powder - 4500 grams, sand - 4500 grams, water - 4500 grams, grout - 4500 grams, for a total weight of 45,000 grams.
  • the particle sizes of the copper powder, tourmaline powder, sand, and isoprene rubber powder were within the range of 0. 1 mm to 5 mm in diameter.
  • An image of the energized water is shown in FIG. 7. The image was captured using a MIRA camera.
  • a medical device was made by contacting isoprene rubber - 22,500 grams, copper powder - 4500 grams, tourmaline powder - 4500 grams, sand comprising silicon dioxide - 4500 grams, water - 4500 grams, grout - 4500 grams, for a total weight of 45,000 grams and mixed into a heterogeneous mixture.
  • the composition was allowed to solidify and sealed into a container.
  • the particle sizes of the copper powder, tourmaline powder, sand, and isoprene rubber powder were within the range of 0. 1 mm to 5 mm in diameter.
  • Example 8 Treatment of Disease with a Medical device
  • a patent suffering from any disease or condition enumerated herein is administered a biophoton therapy with one or more medical devices.
  • the biophoton therapy is administered for at least: 6, 7, or 8 hours a day for about 1, 2, 3, or 4 weeks.
  • the biophoton therapy is administered to a patient that is within 0. 1 meters to 3 meters from the one or more medical devices. After biophoton therapy for about I . 2. 3. or 4 weeks the patient demonstrates an improvement in their disease which can be a quantifiable improvement.
  • Example 9 Treatment of Alzheimer’s disease with a Medical device
  • AD Alzheimer's disease
  • the strong biophoton field generated by medical devices disclosed herein has preliminarily shown a high rate of success in improving cognition and life quality 7 of the patients with AD.
  • the study described in this example was a randomized triple blinded placebo controlled clinical study to verify if biophotons can improve cognition of AD.
  • the clinical trial is planning to enroll a total of 46 participants diagnosed with moderate to severe AD. As an interim, the study outcomes of 1 AD patients are presented here. All participants continued their standard care if any.
  • Alzheimer's Disease causes significant burden to the patient-self, to their family and to society.
  • Patients with AD experience cognitive decline, emotional and psychological impact, physical health issues and a loss of independence.
  • cognitive decline patients experience progressive loss of memory, thinking skills, and the ability to perform every day tasks. This leads to confusion, disorientation, and difficulty in communication.
  • the emotional and psychological impact caused by AD includes anxiety, depression, and a sense of frustration or helplessness as cognitive functions deteriorate.
  • patients can face physical health issues including but not limited to: mobility issues, difficulty swallowing, and increased susceptibility to infections and other illnesses.
  • patients with moderate to severe AD often experience a loss of independence because the gradual decline in cognitive and physical abilities leads to an increased dependency on caregivers for daily activities, which can significantly impact their quality of life.
  • AD society is also burdened by AD due to the economic costs, limited healthcare resources, public health impact, and social services.
  • AD imposes a significant economic burden on healthcare systems due to the high costs of medical care, long-term care facilities, and professional caregiving services. This includes both direct medical costs and indirect costs such as lost productivity.
  • AD also impacts social services, requiring more support for families, including counseling, respite care, and assistance programs to help manage the burden of caregiving.
  • Clinical trials help researchers understand how a treatment affects different aspects of the disease, such as cognitive decline, behavioral changes, and daily functioning. This comprehensive evaluation is crucial for developing treatments that can effectively slow or halt disease progression.
  • Regulatory Approval Regulatory agencies, require robust clinical trial data to approve new treatments. This ensures that only those treatments that have been proven to be safe and effective are made available to patients. Without clinical trials, new treatments could not gain the necessary' regulatory' approval to reach the market.
  • Advancement of Medical Knowledge Clinical trials contribute to the broader understanding of Alzheimer's disease. They can uncover new insights into the disease's underlying mechanisms, identify potential biomarkers for early diagnosis, and reveal how different populations respond to treatment. This knowledge is essential for developing more targeted and effective therapies in the future. (6) Hope for Patients and Families.
  • Alzheimer's disease has a profound impact on patients and their families, and there are currently limited treatment options available. Clinical trials offer hope by exploring new avenues for treatment. Participation in clinical trials also provides patients with access to cutting-edge therapies that are not yet available to the general public. (7) Economic Impact. The burden of Alzheimer's disease on healthcare sy stems and economies is substantial. Effective treatments can reduce the need for long-term care and lower associated costs. Clinical trials are a crucial step in developing these treatments, which can ultimately alleviate the economic burden of the disease. (8) Ethical Responsibility. researchers have an ethical obligation to ensure that any new treatment for Alzheimer's disease is both safe and effective. Clinical trials provide the framework for ethical testing, ensuring that patients' rights are protected and that the potential benefits of new treatments are thoroughly investigated.
  • biophotons generated from medical devices as disclosed herein in treating Alzheimer's disease is an emerging and experimental area of research that holds promise but is still in its early stages.
  • researchers are exploring how biophotons might influence brain function and potentially be harnessed to treat neurological conditions, including Alzheimer's disease.
  • Mechanisms of Action - scientists hypothesize that biophotons might help improve cellular function and communication in the brain, potentially reducing the effects of Alzheimer's. The exact mechanisms are still being studied, but some theories suggest that biophotons could help in reducing oxidative stress, improving mitochondrial function, and enhancing the repair of damaged neural tissues.
  • This example describes the successful use of biophoton therapy administered by a medical device described herein to treat Alzheimer’s disease.
  • Each participant used the Treatment device for at least 8-hours every day for 4-weeks (1- month) during sleep and any time during the day.
  • Each participant guided by study team staff, answered the Integrated Alzheimer's Questionnaires (AQ), and the standard Short Form Health Survey-36 questionnaires (SF-36) for measuring life quality biweekly, respectively at the baseline, after each 2-week of 4-weeks (Treatment Group), 6-weeks (Control Group) or 8 weeks (at home) study treatment.
  • the study participants were monitored with electroencephalography (EEG) at the baseline, and every 7 2-weeks during the study treatment.
  • EEG electroencephalography
  • Alzheimer's Questionnaire (AQ) score [Time Frame: at the baseline to week 4 for the Treatment Group, week 6 for the Control Group] was utilized to determine cognition capability.
  • the AQ is a clinically commonly used tool to measure the severity of Alzheimer’s disease.
  • SF-36 [Time Frame: at the baseline, after each 2-week of 4-weeks (Treatment Group), 6- weeks (Control Group) or 8-weeks (at home) study treatment] was utilized to measure the quality of life as influenced by the placebo or treatment medical device.
  • SF-36 is used worldwide as a standard clinical research tool for many years. Lower SF-36 scores indicate worse life quality due to poor cognition and decreased brain function.
  • EEG electroencephalogram
  • Peripheral Blood Circulation supports numerous standard and new unique features for the benefit of the medical staff and patients alike, such as Simultaneous measurements of up to 10 PVR channels; Quality control of blood pressure measurements; Simultaneous measurements of up to 5 PPG channels; Simultaneous AB1 measurements; Simultaneous Raynaud’s Diagnosis; 10 MHz Doppler probe; Enhanced measurements of blood pressure with PPG; Integrated temperature sensor, or ideal for diagnosis of the Raynaud’s syndrome.
  • MoCA Montreal Cognitive Assessment
  • EEG detected brain injury status from Alzheimer Disease study participants who were treated at the Study Center.
  • the results of the EEG are shown in Table 4.
  • the results showed a reduction in EEG frequency at week 4.
  • the eyes open posterior peak frequency reduced by 10% at Week 4 with a 8.2 Hz compared to 9.2 Hz.
  • the theta/beta ratio reduced by 7% after 4-week exposure.
  • the eyes closed posterior peak frequency reduced from 9.8 Hz to 9.3 Hz after 4-week exposure.
  • the results also showed a reduction in evoked potentials. For example, visual processing decreased by 8 milliseconds (ms) at week 4 as compared to baseline.
  • Auditor ⁇ 7 processing also decreased at week 4, as there was a 15% (24 ms) reduction in time as compared to baseline.
  • Attend on/Vigilance decreased by 5% (17 ms) at week 2, but only had a modest change of 1 ms at week 4.
  • Information procession and working memory modestly decreased by 6 ms.
  • the results of the behavioral motor tests also demonstrate a marked improvement at week 4. For example, reaction time at week 4 decreased by 19% (167 ms) as compared to baseline.
  • the reaction time variance at week 4 also decreased by 55% (4.4 ms) as compared to baseline.
  • FIG. 9A and FIG. 9B shows the peripheral blood circulation in the left and right side of the body detected at the Baseline, week 2 and week 4 after the Study Treatment using the peripheral vascular diagnostic system.
  • the Peripheral blood circulation in the treatment group improved faster than the Control group for both left and right side of the body. This was shown to be statistically significant at week 4.
  • the medical devices herein can emit light at specific wavelengths that penetrate tissues and interact with cellular components. This interaction can stimulate cellular regeneration and repair mechanisms, potentially counteracting the neuronal damage caused by Alzheimer's disease. Enhanced mitochondrial function, promoted by light exposure, could improve energy production in brain cells, supporting their survival and function.
  • Neuroinflammation is a hallmark of Alzheimer's disease, contributing to neuronal damage and cognitive decline.
  • Biophoton therapy has been suggested to possess anti-inflammatory properties.
  • the medical devices herein could alleviate some of the pathological processes driving the progression of Alzheimer's, thereby preserving cognitive function.
  • Enhancement of Neurotransmitter Activity Cognitive functions are heavily reliant on the proper functioning of neurotransmitter systems. Biophoton exposure may enhance neurotransmitter activity, improving synaptic communication and plasticity. This could lead to better memory retention, learning, and overall cognitive performance in Alzheimer's patients.
  • Cognitive Improvement The primary benefit of biophoton therapy in Alzheimer's patients was improvement in cognitive functions. Enhanced neuronal repair, reduced inflammation, and improved neurotransmitter activity can collectively contribute to better memory, attention, and executive functions, significantly improving the patients' ability to perform daily tasks and maintain independence.
  • the medical devices herein represent a treatment for Alzheimer's disease.
  • the medical devices were shown to 1) statistically improve results in the Alzheimer questionnaire after 4 weeks of use; 2) improve the Montreal Cognitive Assessment (MoCA) score of participants; 3) statistically improve the SF-36 scores of participants after 3 and 4 weeks of treatment; 4) improve EEG results; and 5) improve peripheral blood circulation in the left and right side of the body at after 4 w eeks of treatment.
  • MoCA Montreal Cognitive Assessment
  • biophoton therapy could offer a multifaceted approach to managing Alzheimer's symptoms. While more research is needed to establish definitive clinical protocols, the preliminary evidence suggests that biophoton generators hold promise in restoring cognitive function and improving the quality of life for patients with moderate to severe Alzheimer's disease. This innovative therapy could eventually become a valuable component of a comprehensive treatment strategy for this challenging condition

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Abstract

La divulgation concerne des dispositifs médicaux, leurs utilisations, des procédés de fabrication et des kits comprenant des dispositifs médicaux. La divulgation concerne également des utilisations de dispositifs médicaux. Par exemple, des dispositifs médicaux sont utilisés pour produire des biophotons pour une thérapie par biophotons. La divulgation concerne également l'administration d'une thérapie par biophotons pour le traitement de maladies et d'états pathologiques chez un sujet en ayant besoin.
PCT/US2025/014184 2024-02-02 2025-01-31 Dispositifs de traitement de maladies et d'états pathologiques Pending WO2025166282A1 (fr)

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US3145083A (en) * 1959-06-22 1964-08-18 Cabot Corp Production of silicon tetrachloride
US4386182A (en) * 1979-07-24 1983-05-31 Vredestein Icopro B.V. Thermoplastic elastomeric composition containing vulcanized rubber particles and surfactant and process for preparation thereof
US20050220829A1 (en) * 2004-03-30 2005-10-06 Chien-Min Sung Healthcare and cosmetic compositions containing nanodiamond
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