Devices for treating diseases and conditions

Abstract

Disclosed herein are medical devices, uses thereof, methods of manufacture, and kits comprising medical devices. Also disclosed herein are uses of medical devices. For example, medical devices are used to produce biophotons for biophoton therapy. Also disclosed herein is the administration of biophoton therapy for the treatment of diseases and conditions in a subject in need thereof.

Description

[0001] DEVICES FOR TREATING DISEASES AND CONDITIONS

[0002] CROSS REFERENCE TO RELATED APPLICATIONS

[0003] [1] This application claims priority under 35 U.S.C. §119 from Provisional Application Serial No. 63 / 548,967 filed on February 2, 2024, Provisional Application Serial No. 63 / 562,387 filed on March 7, 2024, and Provisional Application Serial No: 63 / 672,867 filed on July 18, 2024, the disclosures of which are incorporated herein by reference in their entirety.

[0004] INCORPORATION BY REFERENCE

[0005] [2] All publications, patents, and patent applications herein are incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. In the event of a conflict between a term herein and a term in an incorporated reference, the term herein controls.

[0006] SUMMARY

[0007] [3] Disclosed herein are medical devices. In some embodiments, 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. In some embodiments, 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. In some embodiments, the medical device can comprise biophotons as measured by a biophoton detector. In some embodiments, the weight to weight ratio of the stone, the sand, the metal, the polymer, and the water can be equal. In some embodiments, 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. In some embodiments, the stone can be the diamond. In some embodiments, 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. In some embodiments, the polysaccharide can comprise a hyaluronic acid or a salt thereof. In some embodiments, the supporting material can be the grout. In some embodiments, the supporting material can be the modified sulfur cement. In some embodiments, the supporting material can be the agar.

[0008] [4] 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. In some embodiments, the biological system can be a human, an animal, a microbial culture, or a plant.

[0009] [5] Also disclosed herein are methods of treating a stroke in a subject in need thereof. In some embodiments, 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. 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. In some embodiments, 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. In some embodiments, 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.

[0010] [6] Also disclosed herein are methods of treating a disease or condition in need thereof. In some embodiments, 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. In some embodiments, 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.

[0011] [7] Also disclosed herein are methods of treating a disease in a subject in need thereof, wherein the disease is selected from the group consisting of: an Alzheimer's disease, a dementia, a Parkinson's disease, a traumatic brain injury (TBI), a long COVID-19, and a depression. In some embodiments, 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. In some embodiments, 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. 1 mm to about 5 mm; wherein the medical device comprises biophotons as measured by a biophoton detector. In some embodiments, 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. In some embodiments, the supporting material can be the grout. In some embodiments, 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. In some embodiments, the stone can be the tourmaline. In some embodiments, the disease can be the long COVID-19. In some embodiments, the disease can be the Alzheimer’s disease. In some embodiments, 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. 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 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. 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 1 or 8 hours per day for at least 1 week. In some embodiments, 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. In some embodiments, 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. In some embodiments, the substantially heterogeneous mixture can be a solid mixture.

[0012] BRIEF DESCRIPTION OF THE DRAWINGS

[0013] [8] The features of the disclosure are set forth with particularity' in the appended claims. A better understanding of the features and advantages of the present disclosure can be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:

[0014] [9] FIGS. 1A-1B shows biophoton release from two different medical devices. FIG. 1A shows the biophoton release from Device A and 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.

[0015]

[0010] 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.

[0016]

[0011] 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.

[0017]

[0012] 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.

[0018]

[0013] 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.

[0019]

[0014] 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.

[0020]

[0015] FIG. 7 shows the difference readings of biophotons of a water bottle before and after being energized with a strong medical device.

[0021]

[0016] FIG. 8 shows the Life Quality (SF-36) scores of Alzheimer’s patients treated with the medical device.

[0022]

[0017] 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.

[0023] DETAILED DESCRIPTION

[0024] Overview

[0025]

[0018] The current disclosure provides 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. Also disclosed herein are 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.

[0026] Definitions

[0027]

[0019] Unless defined otherwise, all terms of art, notations and other technical and scientific terms or terminology used herein are intended to have the same meaning as is commonly- understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some cases, terms with commonly understood meanings are defined herein for clarity and / or for ready reference, and the inclusion of such definitions herein should not necessarily be construed to represent a substantial difference over what is generally understood in the art.

[0028]

[0020] Throughout this application, various aspects may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure.

[0029] Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, 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.

[0030]

[0021] As used herein, the term ‘about’ 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.

[0031]

[0022] As used in the specification and claims, the singular forms “a”, "an” and "the” include plural references unless the context clearly dictates otherwise. For example, the term “a sample” includes a plurality' of samples, including mixtures thereof.

[0032]

[0023] The terms “determining”, “measuring”, “evaluating”, “assessing,” “assaying,” and “analyzing” are often used interchangeably herein to refer to forms of measurement and include 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.

[0033]

[0024] The terms “subject,” “individual,” or “patient” are often used interchangeably herein. 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). In some cases, 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.

[0034]

[0025] 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. For example, 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.

[0035]

[0026] The term “in vivo” may be used to describe an event that takes place in a subject’s body. The term “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.

[0036]

[0027] The term “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.

[0037]

[0028] As used herein, the terms “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. Also, 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. For 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.

[0038]

[0029] Without being bound to any theories, 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. Without being bound to any theories, biophotons can comprise a quantum particle. In some embodiments, a biophoton can comprise a photon. Without being bound to any theories, a biophoton can comprise a photon of light in the ultraviolet and low visible light range that are produced by a system disclosed herein. In some cases, a biophoton can radiant emittance in the visible and ultraviolet frequencies ranges from 1017to 1027W / cm2In some cases, a biophoton herein can be in the wavelength range of about 200 nanometers (nm) to about 800 nm. In some cases, a biophoton herein can be in the wavelength range of about 200 and 1300 nanometers. Without being bound to any theories, a biophoton can comprise an infrared radiation. In some cases, infrared radiation can be electromagnetic radiation with wavelengths between 760 nm and 100,000 nm. Without being bound to any theories, a biophoton can comprise a low-level light therapy (LLLT) or photobiomodulation (PBM). In some cases, low- level light therapy (LLLT) or photobiomodulation (PBM) can comprise light at red and nearinfrared wavelengths (600-1000 nm). In some cases, far infrared light can be comprised in a biophoton. Without being bound to any theories, 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. In some cases, far infrared light can penetrate into the muscles, tissues, joints, and more. In some embodiments, biophotons can be produced by a medical device. In some cases, a biophoton can be produced at least in part by non-living material, such as inorganic material. In some cases, a biophoton can be produced at least in part by an organic material.

[0039]

[0030] As used herein, a “dose” can refer to a measured quantity of a therapeutic agent to be taken or administered at one time.

[0040]

[0031] As used herein, the term “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. The term “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.

[0041]

[0032] As used herein, 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

[0042]

[0033] The term “substantially” or “essentially” 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%,

[0043] 16%, 1 7%, 18%, 19%, 20%, 21 %, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31 %,

[0044] 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%. 41%. 42%. 43%. 44%. 45%. 46%. 47%.

[0045] 48%. 49%. 50%. 51%. 52%. 53%. 54%, 55%. 56%. 57%. 58%. 59%. 60%. 61%. 62%. 63%. 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71 %, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%. 92%. 93%. 94%. 95%. 96%. 97%. 98%. 99%. or 100% In some cases, 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.

[0046]

[0034] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

[0047]

[0035] Medical device

[0048]

[0036] In some embodiments, a medical device can be referred to as a biophoton generator. In some embodiments, a medical device can be referred to as a bioenergy' generator. In some embodiments, a biophoton generator can comprise a medical device. In some embodiments, 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. In some embodiments, a medical device herein can comprise a polymer such as a rubber. In some embodiments, a medical device herein can comprise a sand. In some embodiments, a medical device herein can comprise a metal and / or an alloy. In some instances, a medical device herein can comprise a stone, a sand, a polymer, a metal (or alloy), a water, or any combination thereof. In some cases, a medical device herein can comprise a supporting material to support a mixture of components. In some cases, an ingredient herein in a medical device can be further activated by using a larger medical device on an ingredient. In some embodiments, a medical device can substantially constantly generate and release biophotons in a 3 dimensional field.

[0049]

[0037] In some embodiments, a medical device herein can comprise a stone. In some cases, a medical device herein can comprise a mix of stones, for example 1, 2, 3, 4, 5 or more types of stones. In some cases, a particle size of a stone 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 stone 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 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. In some cases, a stone can comprise an amethyst, a tourmaline, a jade, an obsidian, or any combination thereof. In some cases, amethyst can have a trigonal crystal system and / or a Mohs Hardness value of about 7. In some cases, tourmaline can have a trigonal cry stal system and / or a Mohs Hardness value of about 7-7.5. In some cases, jade can have a monoclinic crystal system and / or a Mohs Hardness value of about 6-7. In some cases, obsidian can have a spherulites and / or a Mohs Hardness value of about 5-6. In some cases, tourmaline and jade can produce negative ions when it is heated up or at room temperature. For example, tourmaline can produce more than about 1500 negative ions per cubic centimeter when heated. In another example, when heated jade can produce around 700 negative ions per cubic centimeter. Tourmaline can be superconductive and can generate a natural infrared wave. In some cases, 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.

[0050]

[0038] In some embodiments, a medical device herein can comprise a polymer. In some cases, a medical device herein can comprise a mix of polymers, for example 1, 2, 3, 4, 5 or more types of polymers. In some cases, a polymer herein is a rubber. In some cases, a polymer herein can comprise a cellulose. In some cases, a polymer herein can comprise a polysaccharide. In some cases, 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. In some cases, a cellulose can comprise an alpha cellulose or a salt thereof. In some cases, 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. In some cases, 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. In some cases, the rubber can comprise an isoprene. In some cases, a rubber herein can be polymer of isoprene. In some cases, a rubber herein can be polymer of butyl. In some cases, 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. In some cases, the rubber can be a natural rubber. In some cases, 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. In some cases, 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.

[0051]

[0039] In some embodiments, a medical device herein can comprise a metal or an alloy. In some cases, 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. In some cases, a metal can be in the form of a powder. In some cases, 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. In some cases, a metal can be in the form of a powder. In some cases, 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. In some cases, 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. In some cases, a metal can comprise a copper, an iron, or both. In some cases, 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.

[0052]

[0040] In some embodiments, a medical device herein can comprise a sand. In some cases, a medical device herein can comprise a mix of sands, for example 1, 2, 3, 4, 5 or more types of sands. In some cases, the sand can comprise silicon dioxide. In some cases, the sand is substantially compnsed of silicon dioxide by weight. In some cases, 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%,

[0053] 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%. 43%. 44%. 45%. 46%. 47%. 48%. 49%.

[0054] 50%. 51%. 52%. 53%. 54%. 55%. 56%. 57%. 58%. 59%. 60%. 61%. 62%. 63%. 64%. 65%.

[0055] 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%,

[0056] 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%,

[0057] 98%, or 99% silicon dioxide by weight. In some cases, 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. In some cases, 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.

[0058]

[0041] In some embodiments, a medical device herein can comprise a water. In some cases, a water can be collected from a natural source. In some cases, 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. In some cases, a water can be a distilled water.

[0059]

[0042] In some embodiments, a medical device can comprise supporting material. In some cases, a supporting material can comprise a grout. In some cases, a supporting material can comprise a concrete. In some cases, a supporting material can comprise an agar. In some cases, an agar can comprise an agar from a seaweed. In some cases, an agar is a food grade agar. In some cases, a supporting material can comprise a sulfur cement such as a modified sulfur cement. In some cases, a supporting material can comprise a cement and / or a polymer. In some cases, a supporting material can comprise adhesive composition. In some cases, a supporting material does not contribute to the production of biophotons in a medical device. In some cases, a supporting material can contribute to the production of biophotons in a medical device.

[0060]

[0043] In some embodiments, 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. In some embodiments, the biophotons produced can penetrate the wall of the container, such as a metal container or a plastic container. In some cases, a biophoton can be detected outside of a container. In some cases, the medical device is active at room temperature and at temperatures less than room temperature or greater than room temperature. In some cases, 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,

[0061] 35 °C, 36 °C, 37 °C, 38 °C, 39 °C, 40 °C, 41 °C, 42 °C, 43 °C, 44 °C, 45 °C, 46 °C, 47 °C, 48

[0062] °C, 49 °C, 50 °C, 51 °C, 52 °C, 53 °C, 54 °C, 55 °C, 56 °C, 57 °C, 58 °C, 59 °C, 60 °C, 61 °C,

[0063] 62 °C, 63 °C, 64 °C, 65 °C, 66 °C. 67 °C, 68 °C, 69 °C, 70 °C, 71 °C, 72 °C, 73 °C, 74 °C, 75

[0064] °C. 76 °C, 77 °C, 78 °C, 79 °C, 80 °C. 81 °C, 82 °C, 83 °C. 84 °C, 85 °C, 86 °C. 87 °C, 88 °C,

[0065] 89 °C, 90 °C, 91 °C, 92 °C, 93 °C, 94 °C, 95 °C, 96 °C, 97 °C, 98 °C, 99 °C, or 100 °C.

[0066]

[0044] In some embodiments, a medical device can be produced by methods disclosed herein. In some instances, 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.

[0067]

[0045] 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. In some case, the ingredient can be in the form of small pieces of a material. For example, the material can be in the form of a granule, a particle, a grain, or a fragment. In some cases, raw material can be processed to be similar in size. For example, 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. In some cases, the material can be in the shape of a sphere, an oval, an amorphous shape, a cube, a crystalline structure, or any combination thereof. In some cases, 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. In some cases, 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. 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm. 0.5 mm. 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm. 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm. 12 mm, 13 mm, 14 mm. 15 mm, 16 mm, 17 mm, 18 mm. 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm, 31 mm, 32 mm, 33 mm, 34 mm, 35 mm, 36 mm, 37 mm, 38 mm, 39 mm, 40 mm, 41 mm, 42 mm, 43 mm,

[0068] 44 mm, 45 mm, 46 mm, 47 mm, 48 mm, 49 mm, 50 mm, 51 mm, 52 mm, 53 mm, 54 mm, 55 mm, 56 mm, 57 mm. 58 mm, 59 mm, 60 mm, 61 mm, 62 mm, 63 mm, 64 mm, 65 mm, 66 mm,

[0069] 67 mm, 68 mm, 69 mm, 70 mm, 71 mm, 72 mm, 73 mm, 74 mm, 75 mm, 76 mm, 77 mm, 78 mm, 79 mm, 80 mm, 81 mm, 82 mm, 83 mm, 84 mm, 85 mm, 86 mm, 87 mm, 88 mm, 89 mm,

[0070] 90 mm, 91 mm, 92 mm, 93 mm, 94 mm, 95 mm, 96 mm, 97 mm, 98 mm, 99 mm, 100 mm, 110 mm, 00 mm, 120 mm, 140 mm, 160 mm, 180 mm, 200 mm, 220 mm, 240 mm, 260 mm. 280 mm, 300 mm, 320 mm, 340 mm, 360 mm, 380 mm, 400 mm. 420 mm. 440 mm. 460 mm, 480 mm, or 500 mm. In some cases, 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. In some cases, 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. 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm. 8 mm, 9 mm, 10 mm, 11 mm, 12 mm. 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm. 20 mm, 21 mm, 22 mm. 23 mm. 24 mm, 25 mm, 26 mm. 27 mm, 28 mm, 29 mm, 30 mm, 31 mm, 32 mm, 33 mm, 34 mm, 35 mm, 36 mm, 37 mm, 38 mm,

[0071] 39 mm, 40 mm, 41 mm, 42 mm, 43 mm, 44 mm, 45 mm, 46 mm, 47 mm, 48 mm, 49 mm, 50 mm, 51 mm, 52 mm. 53 mm, 54 mm, 55 mm, 56 mm, 57 mm, 58 mm, 59 mm, 60 mm, 61 mm,

[0072] 62 mm, 63 mm, 64 mm, 65 mm. 66 mm, 67 mm, 68 mm, 69 mm. 70 mm, 71 mm, 72 mm, 73 mm, 74 mm, 75 mm, 76 mm, 77 mm, 78 mm, 79 mm, 80 mm, 81 mm, 82 mm, 83 mm, 84 mm,

[0073] 85 mm, 86 mm, 87 mm, 88 mm, 89 mm, 90 mm, 91 mm, 92 mm, 93 mm, 94 mm, 95 mm, 96 mm, 97 mm, 98 mm. 99 mm, 100 mm, 110 mm, 00 mm, 120 mm, 140 mm, 160 mm, 180 mm. 200 mm, 220 mm, 240 mm, 260 mm, 280 mm, 300 mm, 320 mm, 340 mm, 360 mm. 380 mm. 400 mm, 420 mm, 440 mm, 460 mm, 480 mm, or 500 mm. In some embodiments, small particles can be preferred over large particles. In some instances, 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.

[0046] In some cases, 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. In some cases, 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.

[0074]

[0047] In some embodiments, the materials can be weighed to achieve an exemplary' ratio of activated materials. In some cases, 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%. For example, if the net weight of the content of the medical device is 1000 g (1 kg), then said ingredients of a stone, a sand, a metal, and a water can be 100g, 100g, 100g, 100g and unactivated material is 600g. In some cases, 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. In some cases, 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%. In some cases, a stone, a sand, a metal, a polymer, and a water can be in a weight to weight ratio of about:

[0075] 1%: 1%: 1%: 1%: 1% and unactivated material at about 95%. In some cases, 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%. In some cases, 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%. In some cases, 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%. In some cases, a stone, a sand, a metal, a polymer, and a water can be in a weight to weight ratio of about:

[0076] 15%: 15%: 15%: 15%: 15% and unactivated material at about 25%. In some cases, 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%. In some cases, a stone, a sand, a metal, a polymer, and / or a water can be in an equal weight to weight ratio. In some cases, a stone, a sand, a metal, a polymer, a water, and / or a supporting material can be in an equal weight to weight ratio. In some cases, 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%. In some cases, 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%,

[0077] 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%,

[0078] 47%, 48%, 49%, 50%. 51%. 52%. 53%. 54%. 55%. 56%. 57%. 58%. 59%. 60%. 61%. 62%.

[0079] 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%,

[0080] 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%,

[0081] 95%, 96%, or 97% for a weight to weight ratio total of 100%. In some cases, a stone, a sand, a polymer, a metal, and / or a water can be added to a mixture in a specific amount. For example, 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. In some cases, 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 g, 1900 g, 2000 g. 2100 g, 2200 g, 2300 g, 2400 g, 2500 g. 2600 g,

[0082] 2700 g. 2800 g, 2900 g, 3000 g, 3100 g. 3200 g. 3300 g, 3400 g, 3500 g, 3600 g. 3700 g. 3800 g,

[0083] 3900 g, 4000 g, 4100 g, 4200 g, 4300 g, 4400 g, 4500 g, 4600 g, 4700 g, 4800 g, 4900 g, 5000 g,

[0084] 5100 g, 5200 g, 5300 g, 5400 g, 5500 g, 5600 g, 5700 g, 5800 g, 5900 g, 6000 g, 6100 g, 6200 g,

[0085] 6300 g. 6400 g, 6500 g, 6600 g, 6700 g, 6800 g. 6900 g, 7000 g, 7100 g, 7200 g, 7300 g. 7400 g,

[0086] 7500 g. 7600 g, 7700 g, 7800 g, 7900 g. 8000 g. 8100 g, 8200 g, 8300 g, 8400 g. 8500 g. 8600 g,

[0087] 8700 g, 8800 g, 8900 g, 9000 g, 9100 g, 9200 g, 9300 g, 9400 g, 9500 g, 9600 g, 9700 g, 9800 g,

[0088] 9900 g, or 10000 g.

[0089]

[0048] In some embodiments, the materials for a medical device can be contacted and / or mixed together. In some cases, the materials are mixed in a substantially heterogeneous or substantially homogeneous mixture. In some cases, one or more of a stone, a sand, a metal, a polymer, a water, and an unactivated material are mixed. In some cases, the material are mixed by a mixer. In some cases, an unactivated ingredient is first added to the mixer then the activated materials are added to the mixer to create a mixed composition. In some cases, an activated material is first added to the mixer then the unactivated material is added to the mixer to create a mixed composition. In some cases, activated materials and unactivated materials are added to the mixer at the same time to create a mixed composition. In some cases, the substantially solid structure can be solidified after the materials are mixed together by different inactive materials such as grouts. In some cases, 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.

[0090]

[0049] In some embodiments, the materials for a medical device can be added into or to a container. In some cases, the materials are substantially mixed prior to adding the materials to a container. In some cases, a container can be a stainless steel container or a plastic container. In some cases, a container can be a glass container or an organic container such as a wood container. In some cases, the container comprises a stainless steel container, an aluminum container, or a mixture of both. In some cases, a container can be a mix of materials. In some cases, a container is a closed container. In some cases, a container is a sealed container. In some cases, the container may not substantially contribute to the production of biophotons. In some cases, the container may contribute to the production of biophotons. Any shape of container can be used. In some cases, 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:

[0091] 1 gram, 5 grams, 10 grams, 20 grams, 30 grams, 40 grams, 50 grams. 60 grams, 70 grams, 80 grams, 90 grams. 100 grams, 200 grams, 300 grams, 400 grams, 500 grams, 600 grams, 700 grams, 800 grams, 900 grams, 1000 grams, 1 kg, 2 kg, 3 kg, 4 kg, 5 kg, 6 kg, 7 kg, 8 kg, 9 kg, 10 kg, 11 kg, 12 kg, 13 kg, 14 kg, 15 kg, 16 kg, 17 kg, 18 kg, 19 kg, 20 kg, 25 kg, 30 kg, 35 kg, 40 kg, 45 kg, 50 kg, 55 kg, 60 kg, 65 kg, 70 kg, 75 kg, 80 kg, 85 kg, 90 kg, 95 kg, or 100 kg.

[0092]

[0050] In some cases, 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. In some cases, 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. 240 ml, 300 ml, 400 ml, 500 ml, 600 ml, 700 ml, 800 ml, 900 ml, 1000 ml, 1100 ml, 1200 ml, 1300 ml, 1400 ml,

[0093] 1500 ml, 1600 ml, 1700 ml, 1800 ml, 1900 ml, 2000 ml, 2100 ml, 2200 ml, 2300 ml, 2400 ml,

[0094] 2500 ml, 2600 ml, 2700 ml, 2800 ml, 2900 ml, 3000 ml, 3100 ml, 3200 ml, 3300 ml, 3400 ml,

[0095] 3500 ml, 3600 ml, 3700 ml, 3800 ml, 3900 ml, 4000 ml, 4100 ml, 4200 ml, 4300 ml. 4400 ml. 4500 ml, 4600 ml, 4700 ml, 4800 ml, 4900 ml, 5000 ml, 5100 ml, 5200 ml, 5300 ml, 5400 ml, 5500 ml, 5600 ml, 5700 ml, 5,760 ml, 5800 ml, 5900 ml, or 6000 ml.

[0096]

[0051] In some embodiments, the biophotons produced by a medical device are produced in a three-dimensional field and can penetrate body of a subject. In some cases, 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. In some cases, 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. In some cases, the biophotons can be active on direct contact with a subject, for example if a subject is touching a medical device. In some instances, 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.

[0097]

[0052] In some embodiments, the biophotons produced by a medical device can be measured with a biophoton detector. In some cases, in order to measure the production of biophotons the device must produce at least about 500 or 1000 biophotons per second.

[0098]

[0053] In some cases, biophotons can be measured at least in part by low-consumption high- sensitivity Complementary Metal Oxide Semiconductor (CMOS) sensors. In some cases, CMOS sensors can have resolution in the UV spectrum visual range and infrared range.

[0099]

[0054] In some cases, a biophotons can be measured by a MIRA camera. In some cases, a biophoton can be detected and / or measured with a photomultiplier or by a CCD camera (e.g., an ultra-low noise CCD camera). In some cases, a biophoton can be measured with a single photon detector. In some cases, a MIRA camera can be a Model 800, MIRA digital multispectral videocamera manufactured by The Daniele Gulla Laboratory, Ecole Universitarie, Bologna, Italy. The MIRA camera, used herein to capture photon and biophoton emissions, is a digital multispectral video camera. In some cases, it can record, process, and save ultraviolet / visible / near infrared spectroscopy (UV-vis-NIR images) and communicate with remote devices. The video camera collects different frames and quickly compares the frames pixel by pixel. In case of minor variations, 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. As a result, 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.

[0100] Treatment of Diseases and Conditions

[0101]

[0055] Disclosed herein are diseases and conditions that can be treated with a biophoton therapy. In some cases, the biophoton therapy can be administered by a medical device. In some cases, a biophoton therapy can be used to supplement and / or improve the health of a subject. In some cases, a biophoton therapy herein can be used to treat a symptom of a disease or condition.

[0102]

[0056] In some cases, 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. In some cases, 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. In some cases, a pain can be a back pain. In some cases, a pain can comprise an acute pain, a chronic pain or both. In some cases, a pain can comprise a neuropathic pain, a nociceptive pain, a radicular pain, or any combination thereof.

[0103]

[0057] In some cases, a biophoton therapy disclosed herein can be used to treat a migraine. In some cases, 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.

[0104]

[0058] In some cases, a biophoton therapy disclosed herein can be used to treat an arthritis. In some cases, an arthritis can comprise a rheumatoid arthritis. In some cases, 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.

[0105]

[0059] In some cases, a composition herein can be administered to improve focus, improve a mood, promote brain health, and / or provide energy. In some cases, 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. In some cases, a biophoton therapy can be used to increase the intelligence level of a subject. In some cases, 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. In some cases, a medical device can be used to enhance an athletic ability. In some cases, the subject can have a low IQ level. In some cases, a medical device can be used to improve the ability to focus.

[0106]

[0060] In some cases, a medical device herein can be used to treat a subject with a chronic fatigue, an insomnia, a mental condition, or any combination thereof. In some cases, a medical device herein can be used to treat a stress, treat a fatigue, or both. In some cases, a stress can be an acute stress, a chronic stress, a physical stress, a phycological stress, or any combination thereof. In some cases, a chronic fatigue system can comprise a physical exhaustion, a mental exhaustion, a difficulty walking or any combination thereof.

[0107]

[0061] In some cases, a biophoton therapy herein can be used to treat a symptom of a disease or condition. In some cases, 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).

[0108]

[0062] In some cases, biophoton therapy disclosed herein can be used to treat a sleep disorder. In some cases, a biophoton therapy disclosed herein can increase sleep duration of a subject. In some cases, 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. In some cases, biophoton therapy disclosed herein can be used to treat an insomnia. In some cases, biophoton therapy disclosed herein can be used to treat a chronic fatigue syndrome. In some cases, 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.

[0109]

[0063] In some cases, biophoton therapy disclosed herein can be used to treat a mental disorder. In some cases, 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. In some cases, biophoton therapy disclosed herein can be used to treat an attention-deficit- hyperactivity disorder (ADHD). In some cases, 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. In some cases, biophoton therapy disclosed herein can be used to treat an autism.

[0110]

[0064] In some cases, a medical device herein can be used to treat a wound and / or accelerate wound healing. In some cases, a wound can be a surgical wound. In some cases, a wound can be a wound from a battlefield or from an accident such as a car accident. In some cases, 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.

[0111]

[0065] In some cases, a biophoton therapy can be used to treat a stroke. In some cases, a stroke is a chronic stroke. In some cases, a stroke is an acute stroke. In some cases, 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. In some cases, biophoton therapy disclosed herein can be used to treat a paralysis (e.g., paralysis after a stroke). In some cases, a biophoton therapy can be used to treat a stroke or a stroke-paralysis.

[0112]

[0066] In some cases, biophoton therapy disclosed herein can be used to treat a dementia. In some cases, 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. In some cases, 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. In some cases, 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. In some cases, the reverse of the loss of cognitive ability is measured using the integrated Alzheimer’s questionnaire (AQ). In some cases, 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. In some cases, 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. In some cases, the biophoton therapy disclosed herein can result in an AQ score of 4 points or less. In some cases, the biophoton therapy as disclosed here can reduce an AQ score of 20 or more. In some cases, improvement in cognition is measured by the Montreal Cognitive Assessment (MoCA). In some cases, a biophoton therapy can result in an increase in MoCA scores. In some cases, 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.

[0113]

[0067] In some cases, 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. In some cases, biophoton therapy disclosed herein can be used to treat a multiple sclerosis. In some cases, a biophoton therapy can be used to promote brain cell function. In some cases, 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. In some cases, a low SF-36 score indicates a low quality of life. In some cases, a higher SF-36 score indicates a high quality of life. In some cases, 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. In some cases, a biophoton therapy can be used to improve brain injury status as measured by electroencephalography (EEG). In some cases, the biophoton therapy can decrease eyes open: posterior peak frequency score as measured by EEG. In some cases, 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. In some cases, the biophoton therapy can decrease eyes open: theta / beta ratio as measured by EEG. In some cases, the eyes open: theta / beta ratio 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. In some cases, the biophoton therapy can decrease eyes closed: posterior peak frequency score as measured by EEG. In some cases, the eyes closed: 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. In some cases, a biophoton therapy can decrease evoked potentials (ERPs). In some cases, the ERPs include, but is not limited to, visual processing, auditory processing, attention / vigilance, and information procession / working memory . In some cases, the ERPs are reduced from about 1 millisecond (ms) to about 5 ms. from about 5 ms to about 10 ms, from about 10 ms to about 20 ms, from about 20 ms to about 50 ms, from about 50 ms to about 100 ms, or from about 100 ms to about 150 ms as compared to the time of a subject prior to biophoton therapy. In some cases, a biophoton therapy can decrease reaction time as measured by EEG as compared to a subject prior to receiving biophoton therapy. In some cases, a biophoton therapy can decrease reaction time variance as measured by EEG as compared to a subject prior to receiving biophoton therapy. In some cases, a biophoton therapy can decrease missed responses as measured by EEG as compared to a subject prior to receiving biophoton therapy. In some cases, a biophoton therapy can decrease wrong responses as measured by EEG as compared to a subject prior to receiving biophoton therapy. In some cases, a biophoton therapycan improve peripheral blood circulation in the left and / or right side of the body as compared to a subject prior to receiving biophoton therapy. In some cases, 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 . In some cases, biophoton therapy disclosed herein can be used to treat a cardiac disorder. In some cases, 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. In some cases, biophoton therapy disclosed herein can be used to treat a hypertension. In some cases, biophoton therapy disclosed herein can be used to treat a heart disease and / or a heart failure.

[0114]

[0068] In some cases, 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. In some cases, a kidney disease can comprise a glomerulonephritis, a kidney stone, a kidney failure, a urinary7tract infection, a lupus, a polycystic kidney disease, an Alport syndrome, an ectopic kidney, a Fabry7disease, 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. In some cases, biophoton therapy disclosed herein can be used to treat a diabetes. In some cases, a diabetes can be a ty pe 1 diabetes or a type 2 diabetes.

[0115]

[0069] In some cases, 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. In some cases, a viral disease is a SARS infection such as SARS-CoV-2, an influenza infection, a rhinovirus infection, or any combination thereof. In some cases, a medical device can be used to increase an immune response. In some cases, 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. In some cases, a biophoton therapy herein can be used to treat an autoimmune disorder. In some cases, a biophoton therapy can be used to treat a Lyme disease.

[0116]

[0070] In some cases, biophoton therapy disclosed herein can be used to treat an anemia. In some cases, an anemia can be due to chemotherapy and / or radiotherapy. In some cases, a biophoton therapy herein can alter a skin temperature, a blood oxygen level, or both. For example, 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.

[0117]

[0071] In some cases, biophoton therapy disclosed herein can be used to treat a gynecological dysmenorrhea, a premenstrual syndrome (PMS), an infertility, or any combination thereof. In some cases, 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.

[0118]

[0072] In some cases, biophoton therapy disclosed herein can be used to treat a seizure disorder. In some cases, 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.

[0119]

[0073] In some cases, biophoton therapy disclosed herein can be used to improve bone health, for example in a subject who has an osteoporosis. In some cases, a biophoton therapy can be used to treat an osteoporosis. In some cases, a biophoton therapy can be used to treat a hip dysplasia.

[0120]

[0074] In some cases, 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. In some cases, the improvement can be compared against cellular activities of a cell, organ, or biological tissue that was not exposed to a biophoton therapy.

[0121]

[0075] In some cases, a biophoton therapy can be used to reduce ageing in a subject, reduce the occurrence or wrinkles, blemishes or both. In some cases, 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 scarring of a skin, a spider vein, a skin textural change, a wrinkle, or any combination thereof. In some cases, a biophoton therapy can be used to induce stem cell proliferation to replace those aged, injured, or diseases cells.

[0122]

[0076] In some cases, a biophoton therapy can be used to treat an eye disorder. In some cases, the eye disorder can be glaucoma. In some cases, 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. In some cases, a biophoton therapy can improve a retina. In some cases, the improved retina can increase visual function, and blood circulation in an eye.

[0123]

[0077] In some cases, a biophoton therapy can be used to treat a mitochondrial deficiency. In some cases, a biophoton therapy can be used to treat a mitochondrial disease. In some cases, 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.

[0124]

[0078] In some cases, a biophoton therapy can be used to treat an asthma, a Chronic Obstructive Pulmonary Disease (COPD), a respiratory disease, or any combination thereof. In some cases, a treatment of a respiratory disease can comprise an increase in breathing capacity after treatment as compared to the breathing capacity before a treatment. In some cases, a biophoton therapy can be used to treat a tinnitus. In some cases, a biophoton therapy can be used to treat a genetic disease. In some cases, a biophoton therapy can be used to treat a neuromuscular disease.

[0125]

[0079] In some cases, a biophoton therapy can be used to treat a gastrointestinal disorder. In some cases 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. In some cases, 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 blurry7vision, 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. In some cases, 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.

[0126]

[0080] In some cases, a biophoton therapy can be used to treat a thyroid disorder. In some cases, a thyroid disorder can comprise hyperthyroidism, hypothyroidism, or any combination thereof. In some cases, a medical device can be used to balance a hormone level, for example in a subject who has a hyperthyroid or hypothyroid function. In some cases, a biophoton therapy can be used to treat a Cushing's disease. In some cases, a biophoton therapy can be used to treat an endocrine disorder.

[0127]

[0081] In some cases, a biophoton therapy can be used to treat delayed growth of a subject (e.g., a short stature), a delayed puberty7, or both. In some cases, a biophoton therapy can be used to induce body growth (e.g., for a child who has a delayed grow th). In some cases, a medical device can be used to increase the metabolism of a human.

[0128]

[0082] In some cases, a medical device can be used to treat a cancer. In some cases, a cancer can be a terminal cancer. In some cases, a cancer can comprise a stage 1 cancer, a stage 2 cancer, a stage 3 cancer, or a stage 4 cancer. In some cases, 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. In some cases, 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. In some cases, a biophoton therapy can be used to treat a lymphedema. In some cases, 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. brain cancer), 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 neoplasms, a colorectal cancer, a craniopharyngioma (e.g., brain cancer), a cutaneous T-cell lymphoma, a ductal carcinoma In Situ (DCIS), an embryonal tumor, a medulloblastoma, an endometrial cancer (e.g., uterine cancer), an ependymoma, an esophageal cancer, an esthesioneuroblastoma (e.g. head and neck cancer), an Ewing sarcoma (e.g., bone cancer), an extracranial germ cell tumor, 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 hypopharyngeal cancer (e.g., head and neck cancer), an intraocular melanoma, an islet cell tumor, a pancreatic neuroendocrine tumor, a soft tissue sarcoma, a kidney (renal cell) cancer, a Langerhans cell histiocytosis, a laryngeal cancer, an eye cancer, a leukemia, a lip and oral cavity cancer (e.g., head and neck cancer), a liver cancer, a lung cancer (e.g., nonsmall cell, small cell, pleuropulmonary blastoma, pulmonary inflammatory myofibroblastic tumor, and tracheobronchial tumor), a lymphoma, a male breast cancer, a melanoma, a melanoma (e.g., intraocular (Eye)), a Merkel cell carcinoma (e g., skin cancer), a mesothelioma, a metastatic cancer, a metastatic squamous neck cancer with occult primary, a midline tract carcinoma with NUT gene changes, a mouth cancer (e.g., head and neck cancer), a multiple endocrine neoplasia syndrome, s multiple myeloma / plasma cell neoplasm, mycosis fungoides (e.g., lymphoma), myelodysplastic syndromes, myelodysplastic / myeloproliferative neoplasms, a myelogenous leukemia (CML) (e.g.. chronic), a myeloid leukemia (AML) (e.g., acute), 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 pheochromocytoma, a pituitary' tumor, a plasma cell neoplasm / multiple myeloma, a pleuropulmonary blastoma, a pregnancy and breast cancer, a primary central nervous system (CNS) lymphoma, a primary peritoneal cancer, a prostate cancer, a pulmonary inflammatory myofibroblastic tumor, a rare cancer, a rectal cancer, a recurrent cancer, a renal cell cancer (e.g., kidney cancer), a retinoblastoma, a rhabdomyosarcoma (e.g., soft tissue sarcoma), a salivary gland cancer, a sarcoma, a childhood rhabdomyosarcoma, a childhood vascular tumor, a bone cancer, a Kaposi sarcoma, an osteosarcoma, a soft tissue sarcoma, a uterine sarcoma, a Sezary syndrome (e.g., lymphoma), a skin cancer, a small cell lung cancer, a small intestine cancer, a soft tissue sarcoma, a squamous cell carcinoma of the skin, a squamous neck cancer with occult primary, a stomach (gastric) cancer, a T-cell lymphoma (e.g.. 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.. endometrial), a uterine sarcoma, a vaginal cancer, a vascular tumor, a vulvar cancer, a Wilms tumor (e.g., kidney tumors), a cancer in young adults, or any combination thereof.

[0129] Additional uses of biophoton therapy

[0130]

[0083] In some embodiments, a biophoton therapy can be used to stimulate a biological process. For example, 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.

[0131]

[0084] In some embodiments, biophoton therapy can be used to increase the rate of fermentation, for example fermentation of an alcohol. In some cases, a fermentation can be in a fermentation tank. In some cases, the rate of fermentation by yeast (e.g., Saccharomyces cerevisiae) can be increased by biophoton therapy. In some cases, 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. In some cases, the yield of a fermentation (e.g., yield of ethanol) can be increased by a biophoton therapy. In some cases, 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.

[0132]

[0085] In some embodiments, 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. In some cases, 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. In some cases, 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. In some cases, administration of a biophoton therapy can increase the rate of therapeutic protein production by a cell. For example, the rate of antibody production by a cell can be increased by biophoton administration to the cell. In some cases, the yield of a protein and / or compound production by a cell can be increased by a biophoton therapy. In some cases, 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.

[0133]

[0086] In some cases, a medical device can be used to infuse a water, a beverage, a soda, and / or juices with biophotons. In some cases, a water or a beverage can be energized with biophotons produced by a medical device. In some cases, 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. In some cases, a beverage can comprise an alcoholic beverage (e.g., a wine, a beer, or a liquor). In some cases, a beverage can comprise a juice, a soft drink, or any beverage. In some cases, a biophoton therapy can be used to increase the aging process / speed of a wine, liquor, or other beverage.

[0134]

[0087] In some embodiments, a biophoton therapy can be used to promote the grow th of an animal, such as a farm animal. In some cases, a farm animal can comprise chickens, ducks, pigs, sheep, cows, and / or horses. In some cases, biophoton therapy can be used to increase the weight of an animal. In some cases, 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. In some cases, 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. In some cases, 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.

[0135]

[0088] In some cases, 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. In some cases, 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. In some cases, the yield of a crop of a plant (e.g., the total fruit / product produced) can be increased by a biophoton therapy. In some cases, 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.

[0136] Administration

[0137]

[0089] In some embodiments, a medical device as disclosed herein can be used to administer biophotons to a subject. In some cases, the administration of biophotons to a subject is referred to herein a biophoton therapy.

[0138]

[0090] Biophoton therapy can be administered to a subject by placing a medical device near the subject. For example, 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.

[0139]

[0091] In some embodiments, to receive biophoton therapy, 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. In some cases, to receive biophoton therapy, 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. 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 to a medical device. In some cases, the biophotons can be active on direct contact with a subject, for example if a subject is touching a medical device.

[0092] In some embodiments, 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.

[0140]

[0093] In some embodiments, 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. In some embodiments, 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,

[0141] 21 min, 22 min, 23 min, 24 min, 25 min, 26 min, 27 min, 28 min, 29 min, 30 min, 31 min, 32 min, 33 min, 34 min. 35 min, 36 min, 37 min, 38 min, 39 min, 40 min, 41 min. 42 min, 43 min,

[0142] 44 min, 45 min, 46 min, 47 min, 48 min, 49 min, 50 min, 51 min, 52 min, 53 min, 54 min, 55 min, 56 min, 57 min, 58 min, 59 min, or 60 min per dose. In some embodiments, 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. 15 hours, 16 hours, 17 hours, 18 hours, 19 hours, 20 hours, 21 hours, 22 hours, 23 hours, 24 hours, 25 hours, 26 hours, 27 hours, 28 hours, 29 hours, 30 hours, 31 hours, 32 hours, 33 hours, 34 hours, 35 hours, 36 hours, 37 hours, 38 hours, 39 hours, 40 hours, 41 hours, 42 hours, 43 hours, 44 hours, 45 hours, 46 hours, 47 hours, or 48 hours per dose. In some cases, 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.

[0143]

[0094] In some embodiments, administering of biophoton therapy (e.g., by a medical device) 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. In some cases, 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. In some cases, 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. In some cases. administration of a biophoton therapy can be performed at least: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,

[0144] 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,

[0145] 38. 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50. 51. 52. 53. 54, 55, 56, 57, 58, 59, 60, 61, 62, 63,

[0146] 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89,

[0147] 90, or more than 90 times a month. In some cases, administering can be performed daily, weekly, monthly, or as needed. In some cases, administration can be performed by a subject (e.g., the patient), a health care provider, or both.

[0148]

[0095] In some embodiments, 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,

[0149] 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55. 56. 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68,

[0150] 69. 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81. 82. 83. 84. 85. 86, 87, 88, 89, 90, 91, 92, 93, 94,

[0151] 95, 96, 97, 98, 99, 100, 150, 200, 300, 400, 500, 600, 700, 800, 900, or 1000 days consecutive or nonconsecutive days. In some cases, 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.

[0152]

[0096] In some embodiments, 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.

[0153]

[0097] In some embodiments, a biophoton therapy can be administered with 1 or more medical devices. In some cases, 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. In some cases, 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. 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37. 38. 39. 40. 41. 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76,

[0154] 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89. 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100 medical devices.

[0155]

[0098] In some cases, administering a biophoton therapy herein can comprise administering an amount sufficient to treat a disease, condition, and / or symptom. In some cases, 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 pm2 / sec as measured by a MIRA camera. In some cases, 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, 33 million biophotons, 34 million biophotons, 35 million biophotons, 36 million biophotons, 37 million biophotons, 38 million biophotons, 39 million biophotons, 40 million biophotons in 600 pm2 / sec as measured by a MIRA camera.

[0156]

[0099] In some cases, 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. In some instances, 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.

[0157] Kits

[0158]

[0100] In some embodiments, a medical device disclosed herein can be comprised in a kit. In some cases, the materials for a medical device (e.g., a stone, a polymer, a metal, a sand, a water and / or an unactivated ingredient) can be comprised in a kit. In some cases, the materials are comprised in a kit individually or in combination. In some cases, a kit can comprise a container. In some cases, a container can be any container such as a glass container, a metal container, a plastic container, a wood container, or any combination thereof.

[0159]

[0101] Numbered Embodiments

[0160]

[0102] A number of devices, and methods are disclosed herein. Specific exemplary embodiments of some of these methods are disclosed below. The following embodiments recite non-limiting permutations of combinations of features disclosed herein. Other permutations of combinations of features are also contemplated. In particular, each of these numbered embodiments is contemplated as depending from or relating to every previous or subsequent numbered embodiment, independent of their order as listed.

[0161]

[0103] Numbered Embodiments Section 1:

[0162]

[0104] 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; 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 the medical device comprises biophotons as measured by a biophoton detector and thereby treating the stroke in the subject in need thereof.

[0163]

[0105] Embodiment 2. The method of embodiment 1, wherein the supporting material is the grout.

[0164]

[0106] 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.

[0165]

[0107] Embodiment 4. The method of embodiment 1, wherein the stone is the diamond.

[0166]

[0108] Embodiment 5. The method of embodiment 1, wherein the stone is the amethyst.

[0167]

[0109] Embodiment 6. The method of embodiment 1 , w herein the stone is the tourmaline.

[0168] [HO] Embodiment 7. The method of embodiment 1. wherein the stone is the jade.

[0169] [Hl] Embodiment 8. The method of embodiment 1. wherein the stone is the obsidian.

[0112] Embodiment 9. The method of embodiment 1, wherein the metal is the copper.

[0170]

[0113] Embodiment 10. The method of embodiment 1, wherein the metal is the iron.

[0171]

[0114] Embodiment 11. The method of embodiment 1, wherein the polymer is the isoprene rubber.

[0172]

[0115] Embodiment 12. The method of embodiment 1, wherein the polymer is the butyl rubber.

[0173]

[0116] Embodiment 13. The method of embodiment 1, wherein the polymer is the cellulose and comprises an alpha cellulose or a salt thereof.

[0174]

[0117] Embodiment 14. The method of embodiment 1, wherein the polymer is the polysaccharide and comprises a hyaluronic acid or a salt thereof.

[0175]

[0118] Embodiment 15. The method of embodiment 1, wherein the supporting material is the modified sulfur cement.

[0176]

[0119] 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.

[0177]

[0120] 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.

[0178]

[0121] 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.

[0179]

[0122] 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.

[0180]

[0123] Embodiment 20. The method of embodiment 1, wherein the substantially heterogeneous mixture is a solid mixture.

[0181]

[0124] Numbered Embodiments Section 2:

[0182]

[0125] 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 the medical device comprises biophotons as measured by a biophoton detector.

[0183]

[0126] Embodiment 2. The medical device of embodiment 1, wherein the supporting material is the grout.

[0184]

[0127] 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.

[0185]

[0128] Embodiment 4. The medical device of embodiment 1 , wherein the stone is the tourmaline.

[0186]

[0129] Embodiment 5. The medical device of embodiment 1. wherein the stone is the diamond.

[0187]

[0130] Embodiment 6. The medical device of embodiment 1 , wherein the stone is the amethyst.

[0188]

[0131] Embodiment 7. The medical device of embodiment 1, wherein the stone is the jade.

[0189]

[0132] Embodiment 8. The medical device of embodiment 1, wherein the stone is the obsidian.

[0190]

[0133] Embodiment 9. The medical device of embodiment 1. wherein the metal is the copper.

[0191]

[0134] Embodiment 10. The medical device of embodiment 1, wherein the metal is the iron.

[0192]

[0135] Embodiment 11. The medical device of embodiment 1, wherein the polymer is the isoprene rubber.

[0193]

[0136] Embodiment 12. The medical device of embodiment 1, wherein the polymer is the buty l rubber.

[0194]

[0137] Embodiment 13. The medical device of embodiment 1, wherein the polymer is the cellulose and comprises an alpha cellulose or a salt thereof.

[0195]

[0138] Embodiment 14. The medical device of embodiment 1, wherein the polymer is the polysaccharide and comprises a hyaluronic acid or a salt thereof.

[0196]

[0139] Embodiment 15. The medical device of embodiment 1, wherein the polymer is the cellulose and comprises an alpha cellulose or a salt thereof.

[0197]

[0140] Embodiment 16. The medical device of embodiment 1, wherein the polymer is the polysaccharide and comprises a hyaluronic acid or a salt thereof.

[0141] Embodiment 17. The medical device of embodiment 1, wherein the supporting material is the modified sulfur cement.

[0198]

[0142] Embodiment 18. The medical device of embodiment 1, wherein the supporting material is the agar.

[0199]

[0143] Embodiment 19. The medical device of embodiment 1, wherein the sand comprises at least about 98% silicon dioxide.

[0200]

[0144] Embodiment 20. The medical device of embodiment 1, wherein the substantially heterogeneous mixture is a solid mixture.

[0201] Examples

[0202]

[0145] Example 1: Biophoton Release Comparison between two Medical devices

[0203]

[0146] Two medical device devices were tested for their ability to generate biophotons.

[0204]

[0147] The first device (Device A) was an early medical device that comprised: copper powder

[0205] - 100 grams, tourmaline powder - 100 grams, sand comprising silicon dioxide - 100 grams, water

[0206] - 50 grams, grout - 150 grams, for a total weight of 500 grams. The second device (Device B) 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.

[0207]

[0148] FIG. 1A shows Device A released about 7 million biophotons in 600 pm2 / sec as measured by a MIRA camera. In comparison. FIG. IB shows Device B released about 8 million biophotons in 600 gm2 / 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.

[0208]

[0149] Example 2: Biophoton Release Comparison between Combined Materials and a Single Material

[0209]

[0150] Two medical device devices were tested for their ability to generate biophotons. 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.

[0210]

[0151] 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.

[0211]

[0152] Example 3: Biophoton Therapy for the Treatment of Stroke

[0212]

[0153] A randomized double blinded placebo controlled two group comparison clinical study was conducted on chronic stroke patients. Thirty' -three patients with chronic stroke between 0.6 years to 24 years since their last stroke were enrolled in the study.

[0213]

[0154] The patient demographic of the stroke study is shown in Table 1.

[0214] Table 1: Patient demographic for stroke study

[0215]

[0155] The treatment comprised administration of biophoton therapy w ith a medical device. For the treatment group (and control group once switched to treatment after week 2), 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.

[0216]

[0156] 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.

[0217]

[0157] 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.

[0218]

[0158] A variety of metrics were used to compare the treatment group vs. the control group and are described below.

[0219]

[0159] 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. For the current study, scores of SIS were obtained weekly by the clinical study team staffer, from the study participant or his / her caregiver. In FIG. 3 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,

[0220] 1.08 in week 2, 1. 16 in week 3, and 1. 17 in week 4. The scores for the control group were: 1.0 at week 0 (baseline), 1.01 in week 1, 1.01 in week 2, 1.04 in week 3, 1.07 in week 4, 1.09 in week 5, and 1.09 in week 6.

[0221]

[0160] Statistical analysis for data in FIG. 3, was completed with a two-group ANOVA analysis and / or a self-comparison against the baseline values, by an ANOVA analysis.

[0222]

[0161] The control group compared to the baseline control group:

[0223]

[0162] Comparing the changes from the baseline at each week (weeks 1 to 6), 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.

[0224]

[0163] The treatment group compared to the baseline treatment group:

[0225]

[0164] Comparing the changes from the baseline, the p-values are 0.0032, 0.0006, 0.0001, 0.0002 after the treatment started for 1 - 4 weeks respectively.

[0226]

[0165] Comparing the treatment group against the control group (Comparing the weekly changes from baseline between the two groups):

[0227]

[0166] 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.

[0228]

[0167] Comparing the two groups after receiving the active treatment for 1 - 4 weeks, a) treatment Week 1 vs. Control Week 3; b) treatment Week 2 vs. Control Week 4; c) treatment Week 3 vs. Control Week 5; d) treatment Week 4 vs. Control Week 6. The p-values are 0.5059, 0.6215. 0.2570, 0.1443 respectively. After receiving the treatment, there was no difference between these two groups.

[0229]

[0168] The stroke recovery rate 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. In FIG.

[0230] 4 the Y-Axis shows the percentage of the stroke recovery rate, and the X-axis shows the length of time of the study.

[0231]

[0169] Statistical analysis of the stroke recovery rates betw een the tw o groups was completed with a Self-comparison ANOVA against Baseline value and / or a tw o-group ANOVA analysis:

[0232]

[0170] The control group:

[0171] 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.

[0233]

[0172] The treatment group:

[0234]

[0173] Comparing the changes from the baseline, the p-values are 0.0119, 0.0032, 0.0077, 0.0005 after the treatment started for 1 - 4 weeks respectively, which shows a statistically significant increase in each week. This is similar with what was observed in the Control group - a numerical improvement was shown after 1 week of treatment and the improvement became statistically significant starting at week 2 of treatment.

[0235]

[0174] Comparing the treatment group against the control group:

[0236]

[0175] Comparing the weekly changes from baseline between the two groups

[0237]

[0176] 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.

[0238]

[0177] Comparing the two groups after receiving the active treatment for 1 - 4 weeks, a) treatment Week 1 vs. Control Week 3; b) treatment Week 2 vs. Control Week 4; c) treatment Week 3 vs. Control Week 5; d) treatment Week 4 vs. Control Week 6. The p-values are 0.5059, 0.6215. 0.2570, 0.1443 respectively. Comparing the improvement after receiving the same time of treatment, there was no difference between these two groups.

[0239]

[0178] The Neurologic Exam Scores of the patients with chronic stroke improved after using medical devices as show n in FIG. 5. The observation of change was performed objectively by the clinical research physician. 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.

[0179] 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. In FIG. 6 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. As shown in FIG. 6, 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.

[0240] [ISO] As shown in FIG. 6, patients with chronic stroke had no placebo effect for their disability or life quality during the 4 weeks at home before the study, nor 2-week stay in a hotel where the clinical study was conducted. After switching to treatment, they had reduced disability after using the medical device.

[0241]

[0181] In summary, the control group during the first two weeks (placebo phase) did not have any significant changes in SIS percentage change (see FIG. 3), stroke recover rate change (see FIG. 4), neurological exam scores (see FIG. 5). and SF-36 scores (see FIG. 6) as compared to the treatment group which had improvement in all measured assays. After the control group switched to the treatment for 4 weeks, they had improvements in the SIS percentage change, stroke recover rate change, neurological exam scores, and SF-36 scores, which w as similar to the treatment group.

[0242]

[0182] Example 4: Biophoton Therapy for the Treatment of Traumatic Brain Injury (TBI)

[0183] A randomized double blinded placebo controlled two group comparison clinical study for the treatment of Traumatic Brain Injury (TBI) is ongoing. The study comprises thirty -two patients with Traumatic Brain Injury.

[0243]

[0184] 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.

[0244]

[0185] 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. For the control 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.

[0245]

[0186] Preliminary results showed no change in the placebo group during the first two-weeks of the trial in disability, functionality, and a physician-conducted neurologic examination. After switching to the treatment for 4 weeks, the placebo group showed improvements in the physician-conducted neurologic examination, improvements in pain, and improvements in SF-36 scores which w ere similar to the treatment group.

[0246]

[0187] Example 5: Biophoton Therapy for the Treatment of Alzheimer’s Disease

[0247]

[0188] 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. During a 4- week observational period, 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.

[0248]

[0189] 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.

[0249]

[0190] Example 6: Biophoton energized water.

[0250]

[0191] 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.

[0251]

[0192] Example 7: Biophoton energy generator.

[0252]

[0193] 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.

[0253]

[0194] Example 8: Treatment of Disease with a Medical device

[0254]

[0195] 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.

[0255]

[0196] Example 9: Treatment of Alzheimer’s disease with a Medical device

[0256]

[0197] Background. Alzheimer's disease (AD) poses a significant global health challenge, which demands innovative therapeutic approaches. The strong biophoton field generated by medical devices disclosed herein has preliminarily shown a high rate of success in improving cognition and life quality7of the patients with AD.

[0257]

[0198] 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.

[0258]

[0199] During a 4-week observational period, 16 participants in the treatment group used the medical device daily. Cognitive function, life quality and EEG were assessed using standardized measurements. Preliminary analysis revealed an improvement in cognitive performance among participants in the biophoton therapy group compared to the control group. Seventy-five percent (75%) participants had a reduced the Alzheimer’s Questionnaire severity; and eighty-three percent (83%) participants had an increased life quality as determined using the standard Short Form Health Survey-36 (SF-36) score. All were significantly different from the Control group (P < 0.01). EEG test also showed that the “missed response” was reduced in the Treatment group. Caregivers reduced the stress and difficulty in caring for their seniors. No adverse effects were observed.

[0259]

[0200] These promising results highlight the potential of biophoton therapy generated by medical devices disclosed herein for treatment of Alzheimer's disease. This clinical study represents a significant step forward in treating Alzheimer's disease

[0260]

[0201] Introduction: 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. First, with 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. Second, the emotional and psychological impact caused by AD includes anxiety, depression, and a sense of frustration or helplessness as cognitive functions deteriorate. Third, as the disease progresses. patients can face physical health issues including but not limited to: mobility issues, difficulty swallowing, and increased susceptibility to infections and other illnesses. Lastly, 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.

[0261]

[0202] The families and caregivers of those affected by AD often experience emotional strain, financial burden, time and effort, and social isolations. First, families often experience emotional strain including grief, stress, and emotional exhaustion as they watch their loved one decline. The emotional toll can be profound, especially as personality changes and memory loss deepen. Second, financial burden including the cost of care can be substantial, including medical treatments, home modifications, and professional caregiving. Many families face significant financial strain due to these expenses. Third, caregiving often requires extensive time and effort, leading to potential neglect of other responsibilities, including work, social relationships, and personal health. Lastly, caregivers and family members may experience social isolation due to the demanding nature of caregiving and the need to prioritize the patient's needs over their own social interactions and activities.

[0262]

[0203] Finally, society is also burdened by AD due to the economic costs, limited healthcare resources, public health impact, and social services. First, 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. Second, the increasing prevalence of Alzheimer’s places a heavy demand on healthcare resources, including hospitals, nursing homes, and home care services, potentially limiting availability for other patients. Third, as the population ages, the number of Alzheimer's cases is expected to rise, leading to increased public health challenges. This includes the need for more research funding, better diagnostic tools, and effective treatments to manage the disease. Lastly, AD also impacts social services, requiring more support for families, including counseling, respite care, and assistance programs to help manage the burden of caregiving.

[0263]

[0204] Conducting clinical trials to treat Alzheimer's disease is of paramount importance for several reasons: (1) Scientific Validation. Clinical trials provide a rigorous and systematic way to evaluate the safety and efficacy of new treatments. They follow strict protocols to ensure that the results are reliable and reproducible. Without these trials, it would be difficult to determine whether a treatment is truly effective or if observed benefits are due to placebo effects or other factors. (2) Safety Assurance. New treatments should be tested for safety to identify any potential side effects or adverse reactions. Clinical trials are conducted in phases, starting with small groups of volunteers and gradually increasing in size. This phased approach helps to identify and mitigate risks before a treatment is widely available to the public. (3) Efficacy Evaluation. Alzheimer's disease is complex, and its progression can vary widely among individuals. 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. (4) 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. (5) 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.

[0264]

[0205] The use of 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.

[0265]

[0206] Initial studies involving biophotons have shown some promising results in laboratory settings. For example, in vitro (cell culture) experiments have indicated that biophoton emissions might influence neural cell activity and promote cellular health. There have been some animal studies where the effects of biophoton treatments on Alzheimer's models have been investigated. These studies aim to understand how biophoton exposure might alter disease progression in animals exhibiting Alzheimer's-hke symptoms. Results have shown potential improvements in cognitive function and brain pathology, but more extensive research is required. As of now, there are no large-scale clinical trials involving biophotons for Alzheimer's disease in humans.

[0266]

[0207] Methods:

[0267]

[0208] Study design. The clinical study was a randomized, triple-blinded, placebo-controlled prospective intervention clinical research. Sixteen Alzheimer’s disease (AD) patients participated in the study observed by a clinical research physician for 4 or 6-weeks.

[0268]

[0209] Study randomization. The biostatistician prepared a randomization schedule including a serial of subject numbers. The Study Coordinator randomly assigned each qualified male or female AD participant into a Control or Treatment Group by using the subject number.

[0269]

[0210] Two weeks after observing the placebo impact on the participants in the Control Group, the participant was switched to the Treatment, then observed by the study physician for 4 more weeks. Other than the Informed Consent Form (ICF), all study data collection forms were recorded by using the subject number. The Principal Investigator, study physicians, data-entry specialists, and biostatisticians, as well as the participant and caregiver, were blinded about who received which product.

[0270]

[0211] Study enrollment. Each potentially qualified volunteer (with caregiver) reviewed the Informed Consent Form online (e-ICF) and Enrollment Criteria online (e-Criteria) first, then discussed the e-ICF and e-Criteria with the study coordinator via telephone during the scheduled time. Each qualified participant signed the e-ICF and sent it to the Study Coordinator. The Study Coordinator assigned the qualified participant a randomized subject number.

[0271]

[0212] Study procedure. Each participant assigned to the Control Group was treated with the current Standard of Care (SOC) plus a set of placebo devices for 2-weeks to observe if there are any placebo effects. Then all were switched to the Treatment Group. Each participant assigned to the Treatment group received SOC plus a set of medical devices.

[0272]

[0213] 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 every72-weeks during the study treatment.

[0273]

[0214] Study supply. All study devices (Placebo or Treatment medical device) were installed in the hotel rooms for use by the at-center study participants; or placed on each side of the pillow for use by those at-home study participants. Each participant was given a special subject code to record the study data according to the randomized Subject Number.

[0274]

[0215] Study participant population. The adult patient who was clinically diagnosed with an AD unable to have an independent life, was considered a qualified participant.

[0275]

[0216] Investigational product and mode of administration. 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 (at least 1000 times lower) 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.

[0276]

[0217] The participant’s caregiver recorded the cognition and brain function changes and answered the standard study questionnaires at the baseline, and after each 2-week of treatment a total of 3-times for the Treatment Group, 4-times for the Control Group and 6-times for at home study.

[0277]

[0218] Comparator and mode of administration. A placebo-device with the same shape, size, and weight of the medical device was also used. The placebo devices comprise sand comprising silicon dioxide - 2000 grams, water - 250 grams, grout - 250 grams, for a total weight of 2500 grams. The comparator device was placed next to the user as long as possible during the entire study period.

[0278]

[0219] The caregiver recorded the cognition and brain function changes and answered the standard study questionnaires. Clinical measurements were conducted by medical professionals for those who participated in at-center study.

[0279]

[0220] Duration of treatment. The at-center study participants in the Control and Treatment Groups actively participated in the study for 4-weeks (Treatment Group) or 6-weeks (Control Group). Each participant’s caregiver answered the standard study questionnaires, respectively at the baseline, at the end of every 2-weeks of the study treatment.

[0280]

[0221] Outcome Variables

[0281]

[0222] Primary Outcome Measure: Cognition Capability

[0282]

[0223] 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.

[0283]

[0224] Secondary Outcome Measure 1 :

[0284]

[0225] 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.

[0285]

[0226] Secondary Outcome Measure 2:

[0286]

[0227] Brain function change detected by using an electroencephalogram (EEG) machine. EEG was performed at the baseline and every 2 weeks during the study.

[0287]

[0228] Secondary Outcome Measure 3:

[0288]

[0229] Peripheral Blood Circulation. The peripheral vascular diagnostic system 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.

[0289]

[0230] Safety Outcome Measure:

[0290]

[0231] Any Adverse Events were recorded by the caregiver during the entire study period. Occurrence of Adverse Events as reported by participants. [Time Frame: Any adverse events occurred at the baseline, at 2-weeks and then at 4-weeks (Treatment Group), 6-weeks (Control Group) or 8-weeks (at home) study treatment.] Any adverse events reported by caregivers were tabulated and compared between the two groups

[0291]

[0232] Results:

[0292]

[0233] Clinical Efficacy Study:

[0293]

[0234] The clinical study observed significant improvements in 16 AD patients using the medical device described herein at a clinical study center. Table 2, shows Alzheimer questionnaire results from patients from the study. A score of 4 points or less is regarded as normal. A score between 5 and 14 points suggest mild cognitive impairment and a score of 15 or more points suggests dementia. The Alzheimer Questionnaire results showed that after 4 weeks of treatment (average score 15.5) there was a significant improvement in the scores as compared to the baseline scores (average score 21.25).

[0294] Table 2. Alzheimer Questionnaires (AQ) of Participants Impacted by the Medical Device

[0295]

[0235] Additionally, the Montreal Cognitive Assessment (MoCA) test was used in several patients. The MoCA is a test used to detect mild cognitive decline and early signs of dementia. The current study participants had severe Alzheimer's disease. The MoCA test results from several patients are shown in Table 3. A higher MoCA score indicates improved cognition. The results showed a modest improvement in total score in cognition as demonstrated with subject # 2, 3, and 4 all exhibited a two score increase after week 4. Subject 1 exhibited a moderate improvement in total score in cognition with a ten score increase as compared to baseline at week 4.

[0296] Table 3, MoCA scores of Participants Impacted by the Medical Device

[0297]

[0236] The SF-36 Life Quality Scores from 16 AD participants who were treated with the medical device are shown in FIG. 8. Each served as the historical control since there is no standard of care which can enable the AD patients to regain cognition. The life quality of the AD patients did not change during the 4-week period before participating in the biophoton treatment study (week -4 to baseline). Life quality was improved after being treated with biophoton generators (week 1 through week 4). By Week 3 and Week 4. the improvement became statistically significant. Among the 12 who completed the 4-week life quality assessment, 10 of them (83.3%) improved their SF-36 scores from about 1550 to about 2050. These results showed the medical device herein increased the Life Quality scores from the patients in the clinical study.

[0298]

[0237] 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. For example, the eyes open posterior peak frequency reduced by 10% at Week 4 with a 8.2 Hz compared to 9.2 Hz. Similarly, the theta / beta ratio reduced by 7% after 4-week exposure. Lastly, 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}7processing 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. Lastly, there were no missed responses at week 4, as compared to baseline (20% missed responses).

[0299]

[0238] Table 4 EEG results of Participants Impacted by the Medical Device

[0239] Blood circulation of the study participants was examined. 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.

[0300]

[0240] DISCUSSION

[0301]

[0241] Potential Mechanisms

[0302]

[0242] Cellular Regeneration and Repair. 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.

[0303]

[0243] Reduction of Neuroinflammation. 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. By reducing inflammation in the brain, the medical devices herein could alleviate some of the pathological processes driving the progression of Alzheimer's, thereby preserving cognitive function.

[0304]

[0244] 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.

[0305]

[0245] Clinical Benefits.

[0306]

[0246] 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.

[0307]

[0247] Improved Mood and Behavior. Alzheimer's disease often comes with mood disorders and behavioral issues, such as depression, anxiety, and aggression. By modulating brain activity and neurotransmitter levels, biophoton therapy can help stabilize mood and reduce behavioral problems, leading to a more positive emotional state and better social interactions.

[0308]

[0248] Increased Quality of Life. By potentially reversing some of the cognitive and behavioral symptoms of Alzheimer's disease, biophoton generators can enhance the overall quality of life for patients. Greater cognitive clarity and emotional stability enable patients to engage more meaningfully with their surroundings, participate in social activities, and maintain a better quality of life despite their condition.

[0309]

[0249] Conclusion

[0310]

[0250] 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. These results show the medical devices herein can be used to treat Alzheimer’s disease.

[0311]

[0251] By leveraging the potential of light to stimulate cellular repair, reduce inflammation, and enhance neurotransmitter activity, 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

[0312]

[0252] While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions can occur to those skilled in the art without departing from the disclosure. It should be understood that various alternatives to the embodiments of the disclosure described herein may be employed in practicing the disclosure. It is intended that the following claims define the scope of the disclosure and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A medical device comprising 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; and wherein the medical device comprises biophotons as measured by a biophoton detector.

2. The medical device of claim 1, wherein the weight to weight ratio of the stone, the sand, the metal, the polymer, and the water are equal.

3. The medical device of claim 1. wherein the 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 about 10% the supporting material.

4. The medical device of claim 1, wherein the stone is the diamond.

5. The medical device of claim 1. wherein the stone is the amethyst.

6. The medical device of claim 1. wherein the stone is the tourmaline.

7. The medical device of claim 1, wherein the stone is the jade.

8. The medical device of claim 1, wherein the stone is the obsidian.

9. The medical device of claim 1. wherein the metal is the copper.

10. The medical device of claim 1. wherein the metal is the iron.

11. The medical device of claim 1, wherein the polymer is the isoprene rubber.

12. The medical device of claim 1, wherein the polymer is the butyl rubber.

13. The medical device of claim 1, wherein the polymer is the cellulose.

14. The medical device of claim 13, wherein the cellulose comprises an alpha cellulose or a salt thereof.

15. The medical device of claim 1, wherein the polymer is the polysaccharide.

16. The medical device of claim 15, wherein the polysaccharide comprises a hyaluronic acid or a salt thereof.

17. The medical device of claim 1, wherein the supporting material is the grout.

18. The medical device of claim 1, wherein the supporting material is the modified sulfur cement.

19. The medical device of claim 1. wherein the supporting material is the agar.

20. A method, comprising placing the medical device of claim 1 within about 0. 1 meters to about 10 meters from a biological system for at least 15 minutes.

21. The method of claim 20, wherein the biological system is a human, an animal, a microbial culture, or a plant.

22. A method of treating a stroke in a subject in need thereof, the method comprising placing the medical device of claim 1 within about 0. 1 meters to about 5 meters from a subject for at least about 1 hour per day.

23. The method of claim 22, 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.

24. The method of claim 22, wherein the subject has 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.

25. The method of claim 22, wherein the subject 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 a medical device for at least about 1 hour per day.

26. The method of claim 22, wherein the subject 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 a medical device for at least about 1 hour per day.

27. The method of claim 22, wherein the subject has 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.

28. A method of treating a disease or condition in need thereof, the method comprising placing the medical device of claim 1 within about 0.1 meters to about 5 meters from a subject for at least about 1 hour per day.

29. The method of claim 28, 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.

30. The method of claim 28, wherein the disease or condition is 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.

31. A method of treating a disease in a subj ect in need thereof, wherein the disease is selected from the group consisting of: an Alzheimer's disease, a dementia, a Parkinson's disease, a traumatic brain injury (TBI), a long COVID-19, and a depression, the method comprising placing a medical device within about 0.1 meters to about 5 meters from the 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, ajade, an obsidian, and any combination thereof;(b) a sand comprising at least about 95% silicon dioxide by w eight;(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 the medical device comprises biophotons as measured by a biophoton detector and thereby treating the Alzheimer's disease, the dementia, the Parkinson's disease, the TBI and the depression in the subject in need thereof.

32. The method of claim 31, wherein the supporting material is the grout.

33. The method of claim 31, 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 about 10% the supporting material.

34. The method of claim 31, wherein the stone is the tourmaline.

35. The method of claim 31, wherein the disease is the long COVID-19.

36. The method of claim 31. wherein the disease is the Alzheimer’s disease.

37. The method of claim 31, wherein the disease is the dementia.

38. The method of claim 31, wherein the disease is the Parkinson’s disease.

39. The method of claim 31, wherein the disease is the TBI.

40. The method of claim 31, wherein the disease is the depression.

41. The method of claim 31, wherein the metal is the copper.

42. The method of claim 31, wherein the polymer is the isoprene rubber.

43. The method of claim 31, wherein the polymer is the butyl rubber.

44. The method of claim 31, wherein the polymer is the cellulose and comprises an alpha cellulose or a salt thereof.

45. The method of claim 31, wherein the polymer is the polysaccharide and comprises a hyaluronic acid or a salt thereof.

46. The method of claim 31. wherein the supporting material is the modified sulfur cement.

47. The method of claim 31 , wherein the medical device is 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.

48. The method of claim 31, wherein the subject in need thereof has 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.

49. The method of claim 31, wherein the subject in need thereof has an increase in a physician-conducted neurologic examination score after about 4 w eeks of treatment as compared to a subject who was not treated with the medical device for at least about 1 hour per day.

50. The method of claim 31. wherein the substantially heterogeneous mixture is a solid mixture.

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