BIOCERAMIC COMPOSITIONS AND BIOMODULATING USES OF THEM

专利摘要:
bioceramic compositions and biomodulating uses thereof. the subject matter described herein is directed to articles, compositions, systems and methods of use and preparation of bioceramic compositions and to bioceramic compositions. a developing bioceramic composition radiates infrared energy or rays and can be used in the treatment of various conditions.
公开号:BR112016026001B1
申请号:R112016026001-5
申请日:2015-05-01
公开日:2021-08-17
发明作者:Shannon Vissman；Francisco Jose Cidral Filho；Francisco de Paula Moreira；Steven Midttun
申请人:Multiple Energy Technologies Llc；
IPC主号:

专利说明:

CROSS REFERENCE
[0001] This order claims the benefit of US Interim Order No. 62/115,567, filed February 12, 2015; US Provisional Application No. 62/064,939, filed October 16, 2014, US Provisional Application No. 62/062,686; filed October 10, 2014, US Provisional Application No. 62/018,085, filed June 27, 2014; and US Provisional Application No. 61/988,837, filed May 5, 2014; the contents of each of them being incorporated by reference, in the present invention, in their entirety. BACKGROUND OF THE INVENTION
[0002] The infrared wavelength ranges from 0.7 to 1000 microns and is just below that of visible light in the electromagnetic spectrum. Infrared has strong physical properties and great thermal activity. SUMMARY OF THE INVENTION
[0003] The natural resonant frequency range of water and living organisms, including man, is within the infrared range. For example, the infrared range of 6 to 18 micrometers is beneficial to the human body because of its activating and energizing effect on the body. In fact, human skin radiates infrared waves at 9.36 micrometers, which is very close to the resonant frequency of a water molecule - and rightly so, since our bodies are made up of about 70% water. Infrared waves are considered a safe and beneficial energy source for human beings. The present inventors have identified beneficial properties of the bioceramic compositions of the invention, as well as applications, as described in the present invention.
[0004] As described in the present invention, bioceramics include ceramics that radiate infrared waves beneficial to living organisms. The subject described here utilizes the beneficial effects of infrared radiation. The methods, articles, systems and compositions of the subject described herein utilize a unique formulation of bioceramic materials, which are ultra-fine mineral particles that, when heated by a living organism such as the human body, emit far infrared energy. The bioceramic materials described herein are refractory polycrystalline compounds which, due to their inertness under aqueous conditions, are highly biocompatible and safe for human application and interaction. The inventors have devised several physiological or biomodulatory applications of these bioceramic formulations, including, but not limited to, regulation of cell metabolism, induction of analgesia, muscle relaxation, and modulation of inflammation and oxidative stress.
[0005] According to the laws of thermodynamics, any two bodies in contact reach thermal equilibrium through a direct microscopic exchange of kinetic energy in the form of electromagnetic radiation generated by the thermal movement of the charged particles in question. Thus, when the bioceramic materials, articles and compositions described herein and the human body are in contact, there is an exchange of thermal radiation, and more specifically, far infrared radiation more specifically. Due to the specific properties of the minerals and oxides contained in the subject described here, that is, the highly refractory minerals, this emission is intensified in the far infrared spectrum which has several physiological or biomodulating effects. The inventors of the present application have unexpectedly discovered several advantages in using the bioceramic materials described herein to complement or serve as a basis for a therapeutic approach to living organisms.
[0006] The subject described in the present invention provides a non-invasive, safe, convenient and effective methodology to provide the positive effects of far infrared therapy to an individual. For example, in some modalities, a patient carries, wears and/or uses the bioceramic compositions, for example, when applied to an article of manufacture such as a shirt, at home and/or while performing daily activities to help extend the benefits of the treatment the patient may receive in a clinic, or to improve the patient's condition during or after exercise.
[0007] A feature of the subject described herein, including articles, subject compositions, methods, devices and systems, is a composition comprising a bioceramic, provided that when heated or exposed to heat, such as human body heat, the bioceramics provides a physiological biomodulating effect when the article is applied to an individual. In some embodiments, the article is an article of clothing such as a shirt.
[0008] Another feature of the subject described here is a bioceramic composition of the subject. For example, in one embodiment, the composition comprises (a) from about 20% by weight to about 80% by weight kaolinite (Al2Si2O5(OH)4); (b) from about 1% by weight to about 30% by weight of tourmaline; (c) from about 1% by weight to about 40% by weight aluminum oxide (Al2O3); (d) from about 1 wt% to about 40 wt% silicon dioxide (SiO2); and (e) from about 1% by weight to about 20% by weight of zirconium oxide (ZrO2); provided the amounts are by total weight of the bioceramic composition. In another embodiment, the composition comprises (a) from about 40% by weight to about 60% by weight kaolinite (Al2Si2O5(OH)4); (b) from about 5% by weight to about 15% by weight tourmaline; (c) from about 15% by weight to about 25% by weight aluminum oxide (Al2O3); (d) from about 10 wt% to about 20 wt% silicon dioxide (SiO2); and (e) from about 1% by weight to about 20% by weight of zirconium oxide (ZrO2); provided the amounts are by total weight of the bioceramic composition. In yet another embodiment, a bioceramic composition is provided which comprises: (a) about 50% by weight of kaolinite (Al2Si2O5(OH)4); (b) about 10% by weight tourmaline; (c) about 18% by weight aluminum oxide (Al2O3); (d) about 14% by weight silicon dioxide (SiO2); and (e) about 8% by weight of zirconium oxide (ZrO2); provided the amounts are by total weight of the bioceramic composition. In some of these modalities, the subject compositions comprise tourmaline, and tourmaline comprises NaFe2+3Al6Si6O18(BO3)3(OH)3OH.
[0009] An additional feature of the subject described here is the provision of a biomodulatory or physiological effect, comprising: a modulation of pain, an increase in muscle endurance, a modulation of the cardiorespiratory system, a modulation of cell metabolism, analgesia, antioxidative effect , an antifibromyalgia effect, a decrease in inflammation, a decrease in oxidative stress, a modulation of cytokine levels, a modulation of blood circulation, a reduction in intolerance to a cold environment, a reduction in a symptom of arthritis or vascular disease, a increased skin perfusion, a decrease in heart rate, a decrease in blood pressure, an aesthetic effect such as a reduction in body measurements), weight reduction or a decrease in the individual's cellulite.
[0010] Yet another feature of the subject described in the present invention is a non-invasive method of providing a physiological or biomodulatory effect in or to an individual, which comprises contacting an article, comprising a bioceramic, with the individual's skin, provided that , when heated or exposed to heat, the bioceramic composition provides far infrared thermal radiation and a biomodulating or physiological effect to the individual in a non-invasive manner.
[0011] Another feature of the subject described herein is a method for preparing an article comprising the steps of: (a) preparing a bioceramic solution; and (b) apply the solution to the article; provided that the solution, when applied to the article, comprises about 20 wt% to about 80 wt% kaolinite (Al2Si2O5(OH)4); about 1% by weight to about 30% by weight tourmaline; about 1% by weight to about 40% by weight aluminum oxide (Al2O3); about 1% by weight to about 40% by weight silicon dioxide (SiO2); and from about 1 wt% to about 20 wt% zirconium oxide (ZrO 2 ), and additionally provided the amounts are by weight of the total bioceramic composition.
[0012] A further feature of the matter described in the present invention is a method for preparing an article comprising the steps of: (a) preparing a bioceramic solution; and (b) applying the solution to the article; provided that, when heated or exposed to heat, the bioceramics provide a biomodulating or physiological effect when the article is applied to an individual. BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The novel and inventive features of the invention are particularly defined in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description, which defines the illustrative embodiments in which the principles of the invention are used, and the associated drawings which, in the present provisional patent application, are provided in the Examples section below.
[0014] Figure 1 illustrates a non-limiting example of a jacket comprising a bioceramic of the present disclosure.
[0015] Figure 2 illustrates a non-limiting example of a jacket and a quilted material quilted material comprising a bioceramic of the present disclosure.
[0016] Figure 3 is a graph illustrating a non-limiting example of the effects of the bioceramics of the present disclosure on flexibility.
[0017] Figure 4 is a graph illustrating a non-limiting example of the effects of the bioceramics of the present disclosure on respiratory capacity.
[0018] Figure 5 is a graph illustrating a non-limiting example of the effects of the bioceramics of the present disclosure on maximum expiratory flow (PEF).
[0019] Figure 6 illustrates a non-limiting example of the effects of the bioceramics of the present disclosure on muscle strength.
[0020] Figure 7 illustrates a non-limiting example of the effects of the bioceramics of the present disclosure on cardiorespiratory fitness.
[0021] Figure 8 illustrates a non-limiting example of the effects of bioceramic paint on CFA-induced mechanical hypersensitivity.
[0022] Figure 9 illustrates a non-limiting example of a bioceramic painting of the present disclosure.
[0023] Figure 10 illustrates a non-limiting example of a quilted material quilted material comprising a bioceramic of the present disclosure.
[0024] Figure 11 illustrates a non-limiting example of a bracelet comprising a bioceramic of the present disclosure.
[0025] Figure 12 is a graph illustrating a non-limiting example of a self-reported reduction in overall pain levels greater than 7.5% in human subjects treated with a device of the present disclosure.
[0026] Figure 13 is a graph illustrating a non-limiting example of a self-reported increase in overall health levels greater than 46% in human subjects treated with a device of the present disclosure.
[0027] Figure 14 is a graph illustrating a non-limiting example of a self-reported reduction in overall fatigue levels greater than 25% in human subjects treated with a device of the present disclosure.
[0028] Figure 15 is a graph illustrating a non-limiting example of a self-reported increase in overall sleep quality greater than 8.5% in human subjects with a device of the present disclosure.
[0029] Figure 16 is a graph illustrating a non-limiting example of a self-reported improvement in overall performance level greater than 7% in human subjects treated with a device of the present disclosure.
[0030] Figure 17 shows a non-limiting example of the absolute infrared emission from smooth tissue (which does not include a bioceramic).
[0031] Figure 18 shows a non-limiting example of the absolute infrared emission of a tissue, comprising 30% of bioceramics of the present disclosure.
[0032] Figure 19 shows a non-limiting example of the absolute infrared emission of a tissue, comprising 50% of bioceramics of the present disclosure.
[0033] Figure 20 comprises non-limiting examples of graphs illustrating that exposure to a padded material padded material with higher concentrations of bioceramic and for longer periods of exposure (both modalities of the present disclosure) induced more lasting results.
[0034] Figure 21 are non-limiting graphs illustrating the effect of adding bioceramic of the present disclosure to a water treatment in a hydroponic system.
[0035] Figure 22 is a non-limiting example of a graph illustrating the low electrical conductivity of water treated with bioceramics of the present disclosure presented from day 16 to day 20, compared to the control group (water only).
[0036] Figure 23 are non-limiting examples of photographs showing the effect of the bioceramics of the present disclosure on the growth of organic products.
[0037] Figure 24 is a graph illustrating a non-limiting example of the analgesic effect of a far infrared (cFIR) emitting bioceramic of the present disclosure compared to a different formulation in the CFA mouse model of induced mechanical hypersensitivity.
[0038] Figure 25 illustrates a non-limiting example of the infrared transmittance of bioceramic compositions other than the present disclosure. Figure 25A illustrates the infrared transmittance of the bioceramic compositions described in the present invention, comprising 18% aluminum oxide, 14% silicon dioxide, 50% kaolinite, 8% zirconium oxide and 10% tourmaline. Figure 25B illustrates the infrared transmittance of the bioceramic compositions described in the present invention, comprising 20% aluminum, 3% titanium, 11% magnesium oxide, 6% ferric trioxide and 60% silica.
[0039] Figure 26 is a graph illustrating the effect of far infrared emitting bioceramic garment on heart rate and functional exercise capacity based on performance of human subjects afflicted with fibromyalgia after a hydrotherapy treatment regimen.
[0040] Figure 27 demonstrates that hydrotherapy, together with the use of the control garment, did not affect the balance of individuals, while the use of far infrared emitting bioceramics statistically reduced the alterolateral oscillations.
[0041] Figure 28 is a graph illustrating the effects of the global perceived pain level of human subjects afflicted with fibromyalgia who are treated with a far infrared emitting bioceramic garment or a fake garment.
[0042] Figure 29A is a graph illustrating the results of a Fibromyalgia Impact Questionnaire (FIQ) (Table A), a McGill Pain Questionnaire (Table B) and McGILL Descriptor Indices (Table C) .
[0043] Figure 30 is a flowchart of the organization of a study on disclosure.
[0044] Figure 31 is a graph illustrating the effect of far infrared emitting bioceramic garment on postural control.
[0045] Figure 32 is a graph illustrating the effect of the far infrared emitting bioceramic garment on the flexibility and grip strength of Pilates practitioners.
[0046] Figure 33 is a graph illustrating the effect of the far infrared emitting bioceramic garment on the (lateral) stabilometry of pilates practitioners.
[0047] Figure 34 is a graph illustrating the effect of the far infrared emitting bioceramic garment on the stabilometry (anteroposterior) of pilates practitioners.
[0048] Figure 35 illustrates the effect of the far infrared emitting bioceramic garment on the heart rate variability (HRV) of Pilates practitioners.
[0049] Figure 36 illustrates the results of the far infrared emitting bioceramic garment on daytime dysfunction (panel A), sleep quality (panel B) and sleep efficiency sleep efficiency (panel C).
Figure 37 illustrates the results of the far infrared emitting bioceramic garment on sleep duration (panel A), sleep disturbance (panel B) and PQSI (panel C).
[0051] Figure 38 illustrates the London Chest Activity Questionnaire London chest activity results in individuals affected with chronic obstructive pulmonary disease (COPD).
[0052] Figure 39 illustrates the results of the performance-based functional exercise capacity test in individuals afflicted with chronic obstructive pulmonary disease (COPD).
[0053] Figure 40 illustrates the results of a test of heart rate variance (HRV) (frequency domain) in individuals afflicted with chronic obstructive pulmonary disease (COPD) before and after treatment with a bioceramic.
[0054] Figure 41 illustrates the results of a test of heart rate variance (HRV) (time domain) in individuals afflicted with chronic obstructive pulmonary disease (COPD) before and after treatment with a bioceramic.
[0055] Figure 42 illustrates the results on the initial VO2 consumption of young baseball players exercising with bioceramic shirts or fake shirts.
[0056] Figure 43 illustrates the results on the initial VO2 max of young baseball players exercising with bioceramic shirts or fake shirts.
[0057] Figure 44 illustrates the aerobic threshold results of young baseball players exercising with bioceramic shirts or fake shirts.
[0058] Figure 45 illustrates the anaerobic threshold results of young baseball players exercising with bioceramic shirts or fake shirts.
[0059] Figure 46 illustrates heart rate recovery of young baseball players exercising with bioceramic shirts or fake shirts.
[0060] Figure 47A illustrates the results of the far infrared emitting bioceramic garment on the sleep duration (panel A), sleep disturbance (panel B) and daytime dysfunction (panel C) of baseball players young. Figure 47B illustrates far infrared emitting bioceramic garment results on daytime dysfunction due to drowsiness (panel A), sleep latency (panel B), and PQSI (panel C) of young baseball players. DETAILED INVENTION
[0061] As used in this document, the singular forms "a", "an" and "the" include plural references unless the context clearly specifies otherwise. Unless otherwise defined, all technical and scientific terms used in this document have the same meaning as commonly understood by a person of ordinary skill in the art. As used in this document, the term "comprising" means "including, but not limited to".
[0062] Without being bound by theory, the present inventors have discovered that the biological effects of bioceramics are based on the fact that the infrared frequency range is the natural resonant frequency range of water and living organisms. Because a considerable part of living organisms include water, the resonance frequency of the water molecules irradiated from the bioceramics described here can activate water and affect living organisms, including humans, and including the treatment of disease, complications and pathways. biological.
[0063] The bioceramics of revelation radiates far infrared energy towards the body or away from the body of an individual. When bioceramics radiate energy into an individual's body, the bioceramics deliver concentrated radiant energy to the cells, reflecting far infrared energy or body heat rays to the individual's joints, muscles and tissues. Far infrared energy penetrates cells and provides biomodulatory or physiological effects such as anti-inflammatory, analgesic and other biomodulatory or physiological effects. When bioceramics radiate energy away from an individual's body, the bioceramics prevent the far infrared energy from penetrating an individual's skin, thus providing a cooling effect. Bioceramic Compositions
[0064] One aspect of the articles, subject compositions, methods, devices and systems described herein is a bioceramic composition which, in certain applications, provides a physiological or biomodulating effect. For example, in some embodiments, a bioceramic composition is provided which, when heated or exposed to heat, provides a physiological or biomodulating effect when the article is applied to an individual. In one embodiment, bioceramics comprises: a. about 20% by weight to about 80% by weight kaolinite (Al2Si2O5(OH)4); b. about 1% by weight to about 30% by weight tourmaline; c. about 1% by weight to about 40% by weight aluminum oxide (Al2O3); d. about 1% by weight to about 40% by weight silicon dioxide (SiO2); and is. about 1% by weight to about 20% m and weight of zirconium oxide (ZrO2); provided the amounts are by the total weight of the bioceramic composition.
[0065] In extra or additional embodiments, a bioceramic composition of matter is provided which, when heated or exposed to heat, provides a physiological or biomodulating effect when the article is applied to an individual, comprising: a. about 40% by weight to about 60% by weight kaolinite (Al2Si2O5(OH)4); b. about 5% by weight to about 15% by weight of tourmaline; c. about 15% by weight to about 25% by weight aluminum oxide (Al2O3); d. about 10 wt% to about 20 wt% silicon dioxide (SiO2); and is. about 1% by weight to about 20% m and weight of zirconium oxide (ZrO2); provided the amounts are by the total weight of the bioceramic composition. In some embodiments, the bioceramic composition comprises kaolinite in a range of from about 45% by weight to about 55% by weight. In extra or additional embodiments, a bioceramic composition comprising kaolinite, in the range of from about 47% by weight to about 53% by weight, is provided. In extra or additional embodiments, a bioceramic composition is provided which contains kaolinite in a range of about 48% by weight to about 52% by weight.
In some embodiments, a bioceramic composition comprising the same is provided. about 50% by weight of kaolinite (Al2Si2O5(OH)4); b. about 10% tourmaline by weight; c. about 18% by weight aluminum oxide (Al2O3); d. about 14% by weight silicon dioxide (SiO2);ee. about 8% by weight of zirconium oxide (ZrO2).
[0067] Another feature of the subject described here are bioceramic compositions that include tourmaline. As used in the present invention, the term "tourmaline" retains its known meaning in mineral and gemstone techniques. For example, tourmaline is a group of isomorphic minerals with an identical crystalline lattice. Each member of the tourmaline group has its own chemical formula, due to small differences in their elemental distribution. For example, in some modalities, tourmaline has the following general formula X1Y3Al6(BO3)3Si6O18(OH)4, where X = Na and/or Ca and Y = Mg, Li, Al and/or Fe2+, which is represented with a following formula, (Na,Ca)(Mg,Li,Al,Fe2+)3Al6(BO3)3Si6O18(OH)4.
[0068] In some embodiments, Al can be replaced by other elements. For example, in uvite, Al is partially replaced by Mg, which expands the formula to: (Na,Ca)(Mg,Li,Al,Fe2+)3 (Al,Mg,Cr)6(BO3)3Si6O18(OH) 4.
[0069] In some embodiments, tourmaline is buergerite, which contains three O atoms and one F atom in place of the OH radical. A buergerite molecule also contains an Fe atom that is in a 3+ oxidation state, which is depicted as:(Na,Ca)(Mg,Li,Al,Fe2+,Fe3+)3(Al,Mg,Cr)6 (BO3)3Si6O18(OH,O,F)4. In other modalities, tourmaline is one of the following:• schorlite: NaFe2+3Al6(BO3)3Sí6Oi8(OH)4;• dravite: NaMg3Al6(BO3)3Si6Oi8(OH) )4;• Elbaite: Na(Li,Al)3Al6(BO3)3Si6O18(OH)4;• Lidicoatite: Na(Li,Al)3Al6(BO3)3Si6O18(OH)4;• uvite: Ca(Mg,Fe2+) 3Al5Mg(BO3)3Si6O18(OH)4;• buergerite: NaFe3+3Al6(BO3)3Si6O18O3F. In one modality, the bioceramic composition is tourmaline comprising NaFe2+3Al6Si6O18(BO3)3(OH)3OH.
[0070] Another aspect of the articles, compositions of matter, methods, devices and systems described in the present invention is a micrometer particle size bioceramic composition. For example, in some embodiments, a bioceramic composition is provided containing the largest dimension of any particle in the bioceramic from about 0.1 micrometer (µm) to about 250 micrometers. In extra or additional embodiments, a bioceramic composition is provided, provided the largest dimension of any particle in the bioceramic is from about 0.5 micrometer to about 25 micrometer. In some cases, a bioceramic particle may have a diameter, or cross-sectional area, from about 0.1 µm to about 1 µm, from about 0.1 µm to about 10 µm, from about 0.1 µm to about 20 μm, from about 0.1μm to about 30 μm, from about 0.1μm to about 40 μm, from about 0.1μm to about 50 μm, from about 0.1μm to about 60 μm, from about 0.1μm to about 70 μm, from about 0.1μm to about 80 μm, from about 0.1μm to about 90 μm, from about 0.1μm to about 100 μm or other desired size. In some cases, an inlet may have a transverse diameter from about 10 µm to about 100 µm, from about 10 µm to about 200 µm, from about 10 µm to about 300 µm, from about 10 µm to about 400 µm, from about 10 µm to about 500 µm, or other desired size.
[0071] In extra or additional modalities, a bioceramic composition of matter is provided which, when heated or exposed to heat, provides a physiological or biomodulating effect when the article is applied to an individual, wherein the bioceramic composition comprises tourmaline, kaolinite and at least one oxide. In some cases, a developing bioceramic comprises tourmaline, kaolinite, aluminum oxide and silicon dioxide. In some cases, a developing bioceramic comprises tourmaline, kaolinite, aluminum oxide, silicon dioxide and another oxide. In some cases, the other oxide is zirconium oxide. In some cases, the other oxide is titanium dioxide (TiO2). In some cases, the other oxide is magnesium oxide (MgO).
[0072] Kaolinite is a layered silicate mineral composed of oxides. In some cases, several oxides are comprised within kaolinite. In some cases, a bioceramic composition comprises additional oxides that are not part of the kaolinite. In some embodiments, a bioceramic composition comprises one oxide, two oxides, three oxides, four oxides, five oxides, six oxides, seven oxides, eight oxides, nine oxides, ten oxides, eleven oxides, twelve oxides or more oxides. In some cases, the additional oxides are highly refractory oxides.
[0073] In some embodiments, an oxide of a bioceramic composition of matter of disclosure has various oxidation states. An oxide of revelation has an oxidation number equal to +1, +2, +3, +4, +5, +6, +7 or +8. In some cases, a bioceramic composition of the disclosure will have more than one oxide, where at least one oxide has a different oxidation number compared to the other oxide. For example, in some cases, a developing bioceramic composition comprises an aluminum oxide (Al2O3) with an oxidation state of +2 or +3, a silicon dioxide (SiO2) with an oxidation state +4 and a zirconium oxide (ZrO2) with oxidation state +4.
[0074] Non-limiting examples of oxides with oxidation state +1 include: copper(I) oxide (Cu2O), dicarbon monoxide (C2O), dichlorine monoxide (Cl2O), lithium oxide (Li2O), potassium oxide (K2O), rubidium oxide (Rb2O), silver oxide (Ag2O), thallium (I) oxide (Tl2O), sodium oxide (Na2O) or water (hydrogen oxide) (H2O).
[0075] Non-limiting examples of oxides with oxidation state +2 include: aluminum (II) oxide (AlO), barium oxide (BaO), beryllium oxide (BeO), cadmium oxide (CdO), calcium oxide (CaO), carbon monoxide (CO), chromium (II) oxide (CrO), cobalt (II) oxide (CoO), copper (II) oxide (CuO), iron (II) oxide (FeO) , lead (II) oxide (PbO), magnesium oxide (MgO), mercury (II) oxide (HgO), nickel (II) oxide (NiO), nitric oxide (NO), palladium (II) oxide (PdO), strontium oxide (SrO), sulfur monoxide (SO), sulfur dioxide (S2O2), tin (II) oxide (SnO), titanium (II) oxide (TiO), vanadium oxide (II) ) (VO) or zinc oxide (ZnO).
[0076] Non-limiting examples of oxides with +3 oxidation states include: aluminum oxide (Al2O3), antimony trioxide (Sb2O3), arsenic trioxide (As2O3), bismuth (III) oxide (Bi2O3), boron trioxide (B2O3), chromium oxide (Cr2O3), dinitrogen trioxide (N2O3), erbium (III) oxide (Er2O3), gadolinium (III) oxide (Gd2O3), gallium (III) oxide (Ga2O3), holmium (III) (Ho2O3), indium (III) oxide (In2O3), iron (III) oxide (Fe2O2), lanthanum oxide (La2O3), lutetium (III) oxide (Lu2O3), nickel (III) oxide ) (Ni2O3), phosphorus trioxide (P4O6), promethium (III) oxide (Pm2O3), rhodium (III) oxide (Rh2O3), samarium (III) oxide (Sm2O3), scandium oxide (Sc2O3), oxide of terbium (III) (Tb2O3), thallium (III) oxide (Tl2O3), thulium (III) oxide (Tm2O3), titanium (III) oxide (Ti2O3), tungsten (III) oxide (W2O3), oxide of vanadium(III) (V2O3), ytterbium(III) oxide (Yb2O3) or yttrium(III) oxide (Y2O3).
[0077] Non-limiting examples of oxides with +4 oxidation states include: carbon dioxide (CO2), carbon trioxide (CO3), cerium (IV) oxide (CeO2), chlorine dioxide (ClO2), chromium oxide (IV) (CrO2), dinitrogen tetroxide (N2O4), germanium dioxide (GeO2), hafnium oxide (IV) (HfO2), lead dioxide (PbO2), manganese dioxide (MnO2), nitrogen dioxide (NO2 ), plutonium (IV) oxide (PuO2), rhodium (IV) oxide (RhO2), ruthenium (IV) oxide (RuO2), selenium dioxide (SeO2), silicon dioxide (SiO2), sulfur dioxide ( SO2), tellurium dioxide (TeO2), thorium dioxide (ThO2), tin dioxide (SnO2), titanium dioxide (TiO2), tungsten (IV) oxide (WO2), uranium dioxide (UO2), oxide vanadium (IV) (VO2) or zirconium dioxide (ZrO2).
[0078] Non-limiting examples of oxides with oxidation state +5 include: antimony pentoxide (Sb2O5), arsenic pentoxide (As2O5), dinitrogen pentoxide (N2O5), niobium pentoxide (Nb2O5), phosphorus pentoxide (P2O5) , tantalum pentoxide (Ta2O5) or vanadium oxide (V) (V2O5). Non-limiting examples of oxides with +6 oxidation states include: chromium trioxide (CrO3), molybdenum trioxide (MoO3), rhenium trioxide (ReO3), selenium trioxide (SeO3), sulfur trioxide (SO3), trioxide tellurium (TeO3), tungsten trioxide (WO3), uranium trioxide (UO3) or xenon trioxide (XeO3).
[0079] Non-limiting examples of oxides with +7 oxidation states include: dichlorine heptoxide (Cl2O7), manganese heptoxide (Mn2O2), rhenium oxide (VII) (Re2O7) or technetium oxide (VII) (Tc2O7). Non-limiting examples of oxides with oxidation states + 8: osmium tetroxide (OsO4), ruthenium tetroxide (RuO4), xenon tetroxide (XeO4), iridium tetroxide (IrO4) or hassium tetroxide (HsO4). Non-limiting examples of oxides with various oxidation states include antimony tetroxide (Sb2O4), cobalt (II, III) oxide (Co3O4), iron (II, III) oxide (Fe3O4), lead (II, IV) oxide ( Pb3O4), manganese oxide (II, III) (Mn3O4) or silver oxide (I, III) (AgO).
[0080] In extra or additional embodiments, a bioceramic composition subject of the disclosure further comprises a metal. A metal can be in elemental form, such as a metal atom, or a metal ion. Non-limiting examples of metals include transition metals, main group metals, and group 3, group 4, group 5, group 6, group 7, group 8, group 9, group 10, group 11, group 12, group 13 metals , group 14 and group 15 of the periodic table. Non-limiting examples of metals include scandium, titanium, vanadium, chromium, manganese, iron, cobalt, nickel, copper, zinc, yttrium, zirconium, niobium, molybdenum, technetium, ruthenium, rhodium, palladium, silver, cadmium, lanthanum, hafnium , tantalum, tungsten, rhenium, osmium, iridium, platinum, gold, mercury, tin, lead and bismuth.
[0081] The proportion of minerals and oxides in a bioceramic composition can be optionally changed depending on a number of variables, including, for example, the amount of thermal radiation, more specifically the amount of far infrared radiation, to be emitted, the disease or condition being treated, the mode of administration, the individual's requirements, the severity of the disease or condition being treated, or the judgment of a clinician. Physical properties
[0082] Tourmaline and kaolinite have distinct granulometric, mineralogical, chemical and physical properties depending, for example, on whether the minerals are extracted from a certain geographic region or whether the minerals are chemically synthesized. For example, in many parts of the world, a kaolinite has a pink-orange-red color that is associated with an amount of impurity(s). Often, the impurity(s) comprise(s) iron oxide. In some embodiments, a developing kaolinite is of a high purity level, and is characterized by a refined white color.
[0083] In some embodiments, the purity of tourmaline or kaolinite is associated with an amount of infrared energy that is radiated from a bioceramic composition. In some cases, the kaolinite or tourmaline of a developing bioceramic composition is more than 99% pure, more than 98% pure, more than 97% pure, more than 96% pure, more than 95% pure, more than 94% pure, more than 93% pure, more than 92% pure, more than 91% pure, more than 90% pure, more than 89% pure, more than 88% pure , more than 87% pure, more than 86% pure, more than 85% pure, more than 80% pure, more than 75% pure, more than 70% pure, more than 65% pure, more than 60% pure or more than 55% pure.
[0084] In some embodiments, a granularity of a kaolinite or tourmaline is associated with an amount of infrared energy that is radiated from a bioceramic composition. For example, a bioceramic composition comprising coarser minerals reflects a different amount of infrared energy compared to a bioceramic composition comprising finer sized minerals. In some embodiments, the granularity of a bioceramic composition ranges from about 100 nanometers to about 0.1 micrometer, from about 100 nanometers to about 1 micrometer, from about 100 nanometers to about 10 micrometers, from about 100 nanometers to about 25 micrometers , from about 100nanometers to about 50 micrometers, from about 100nanometers to about 75 micrometers, from about 100nanometers to about 100 micrometers, from about 100nanometers to about 125 micrometers, from about 100nanometers to about 150 micrometers , from about 100 nanometers to about 175 micrometers, from about 100 nanometers to about 200 micrometers, from about 100 nanometers to about 225 micrometers or from about 100 nanometers to about 250 micrometers.
[0085] In some embodiments, the granularity of a bioceramic composition ranges from about 0.5 micrometer to about 1 micrometer, from about 0.5 micrometer to about 10 micrometers, from about 0.5 micrometer to about 25 micrometers , from about 0.5 micrometer to about 50 micrometers, from about 0.5 micrometer to about 75 micrometers, from about 0.5 micrometer to about 100 micrometers, from about 0.5 micrometer to about 125 micrometers, from from about 0.5 micrometer to about 150 micrometers, from about 0.5 micrometer to about 175 micrometers, from about 0.5 micrometer to about 200 micrometers, from about 0.5 micrometer to about 225 micrometers or about 0.5 micrometer to about 250 micrometers. Emission, transmission and reflection of far infrared radiation
[0086] Yet another aspect of the articles, subject compositions, methods, devices and systems described herein is a bioceramic composition that emits, transmits and/or reflects an infrared wavelength when heated or exposed to heat. In some embodiments, a bioceramic is provided. In some embodiments, a bioceramic is provided that absorbs, stores and/or reflects thermal energy, such as far infrared energy or rays. In some embodiments, a bioceramic is provided that emits, transmits, or reflects an infrared wavelength that is far infrared, and that comprises a wavelength of from about 1 micrometer to about 1 millimeter. In extra or additional embodiments, a bioceramic composition is provided that emits, transmits or reflects an infrared wavelength that is from about 3 micrometers to about 15 micrometers. In extra or additional embodiments, described in the present invention is a bioceramic composition that provides a reflectance of the bioceramic at an ambient temperature of 25°C of at least 80% in an infrared range between about 7 micrometers and about 12 micrometers.
[0087] The material emissivity of a bioceramic material can be measured, for example, with a calorimeter or a Flir thermographic camera. A calorimeter can be used to measure the amount of thermal energy that can be received, stored and/or released by an article of clothing comprising a bioceramic. A Flir thermal imager can create a thermal image of various types of garments comprising a developing bioceramic. A Flir thermal imager can detect up to thousands of measurement points in each thermal image and provide emissivity data for each image.
[0088] A developing bioceramic composition is formulated to have the desired refractory properties. In some embodiments, a developing bioceramic reflects about 99% of the received infrared energy or rays, about 98% of the received infrared energy or rays, about 97% of the received infrared energy or rays, about 96% of the received infrared energy or rays received infrared, about 95% of received infrared energy or rays, about 94% of received infrared energy or rays, about 93% of about 92% of about 91% of about 90% of about 89% of about 88% of about 87% of about 86% of about 85% of about 84% of about 83% of about 81% of about 80% of about 79% of about 78% of about 77% of about 76% of about 75 % of about 74% of about 73% of about 72% of about 71% of about 70% of about 65% of about 55% of about 50% of about 45% of about 40% of about 35% of energy or rays energy or rays energy or rays energy or rays energy or rays energy or energy rays or energy rays or energy rays or energy rays or energy rays or energy rays or energy rays or energy rays or energy rays or energy rays or energy rays or energy rays or energy rays or energy rays or energy rays or Rays Energy or Rays Energy or Rays Energy or Rays Energy or Rays Energy or Rays Energy or Rays Energy or Rays Energy or Rays Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared Infrared infrared infrared infrared infrared infrared infrared infrared infrared infrared infrared about 30% of the energy or infrared rays received, about 25% of the energy or beam s received infrared, about 20% of the received infrared energy or rays, about 15% of the received infrared energy or rays, about 10% of the received infrared energy or rays, or about 5% of the received infrared energy or rays.
[0089] In some cases, a developing bioceramics received, more than 98% of the energy or infrared rays received, more than 97% of the energy or infrared rays received, more than 96% of the energy or infrared rays received, more than 95% of the energy or rays infrareds received, more than 94% of the energy or infrared rays received, more than 93% of the energy or infrared rays received, more than 92% of the energy or infrared rays received, more than 91% of the energy or infrared rays received, more than 90% of the energy or infrared rays infrareds received, more than 89% of the energy or infrared rays received, more than 88% of the energy or infrared rays received, more than 87% of the energy or infrared rays received, more than 86% of the energy or infrared rays received, more than 85% of the energy or rays infrareds received, more than 84% of the energy or infrared rays received, more than 83% of the energy or infrared rays received, more than 8 2% of the energy or infrared rays received, more than 81 % of the energy or infrared rays received, more than 80% of the energy or infrared rays received, more than 79% of the energy or infrared rays received, more than 78% of the energy or infrared rays received, more than 77% of the infrared energy or rays received, more than 76% of the infrared energy or rays reflect more of the incoming infrared energy than 99 received, more than 75% of the received infrared energy or rays, more than 74% of the received infrared energy or rays, more than 73% of the energy or infrared rays received, more than 72% of the energy or infrared rays received, more than 71% of the energy or infrared rays received, more than 70% of the energy or infrared rays received, more than 65% of the energy or infrared rays received, more than 60% of the energy or infrared rays received, more than 55% of the energy or infrared rays received, more than 50% of the energy or ray s infrared received, more than 45% of the energy or infrared rays received, more than 40% of the energy or infrared rays received, more than 35% of the energy or infrared rays received, more than 30% of the energy or infrared rays received, more than 25% of the energy or infrared rays received, more than 20% of the energy or infrared rays received, more than 15% of the energy or infrared rays received, more than 10% of the energy or infrared rays received, or more than 5% of the energy or infrared rays received.
[0090] In some cases, a developing bioceramics reflects less than 99% of the received infrared energy or rays, less than 98% of the received infrared energy or rays, less than 97% of the received infrared energy or rays, less than 96% of the received infrared energy or rays, less than 95% of the received infrared energy or rays, less than 94% of the received infrared energy or rays, less than 93% of the received infrared energy or rays, less than 92% of the received infrared energy or rays, less than 91% of the energy or infrared rays received, less than 90% of the energy or infrared rays received, less than 89% of the energy or infrared rays received, less than 88% of the energy or infrared rays received, less than 87% of the energy or infrared rays infrared rays received, less than 86% of the energy or infrared rays received, less than 85% of the energy or infrared rays received, less than 84% of the energy or infrared rays received less than 83% of the energy or infrared rays received, less than 82% of the energy or infrared rays received, less than 81% of the energy or infrared rays received, less than 80% of the energy or infrared rays received, less than 79% of the energy or infrared rays infrareds received, less than 78% of the energy or infrared rays received, less than 77% of the energy or infrared rays received, less than 76% of the energy or infrared rays received, less than 75% of the energy or infrared rays received, less than 74% of the energy or infrared rays infrareds received, less than 73 % of the energy or infrared rays received, less than 72 % of the energy or infrared rays received, less than 71 % of the energy or infrared rays received, less than 70% of the energy or infrared rays received, less than 65% of the energy or rays infrared rays received, less than 60% of the energy or infrared rays received, less than 55% of the energy or infrared rays rbest received, less than 50% of the energy or infrared rays received, less than 45% of the energy or infrared rays received, less than 40% of the energy or infrared rays received, less than 35% of the energy or infrared rays received, less than 30% of the energy or infrared rays infrared energy received, less than 25% of the energy or infrared rays received, less than 20% of the energy or infrared rays received, less than 15% of the energy or infrared rays received, less than 10% of the energy or infrared rays received, or less than 5% of the energy or infrared rays received.
[0091] In some embodiments, bioceramics reflects far infrared energy towards an individual's body and in some embodiments bioceramics reflects far infrared energy away from the individual's body. A bioceramic can provide a cooling effect when it reflects infrared energy away from the body. In some embodiments, a bioceramic is adjacent to or close to an insulator. In some embodiments, an article comprising an insulated bioceramic provides a cooling effect to an individual, provided that, when heated or exposed to heat, the bioceramic reflects the rays of far infrared radiation away from the individual.
[0092] In some embodiments, an article of clothing of the disclosure comprises an insulator that is in contact with or is adjacent to a bioceramic. The insulator can be used in embodiments where the article of clothing comprising the bioceramic is manufactured to reflect far infrared energy away from an individual's body. In some embodiments, the insulator is a material of low thermal conductivity and prevents far infrared energy from being reflected in one direction. Different types of materials can be used to reflect infrared, and non-limiting examples of insulators include rubber, glass, paper, plastic, wood, fabric, aluminum foil or Styrofoam.
[0093] An article of clothing of the disclosure can provide a therapeutically effective amount of infrared to an individual. In some cases, the garment is a jacket comprising a bioceramic, and when exposed to heat, the jacket comprising the bioceramic provides at least 1.5 Joule/cm2 of far infrared radiation to an individual. In some cases, the article of clothing is an article of sporting apparel, sporting accessory, or sporting equipment including, but not limited to, orthotic inserts, athletic shoes, diving suits, life jackets, shirts, shorts, wristbands , armbands, headbands, gloves, jackets, pants, hats and backpacks, skis, ski poles, snowboards, skateboards, inline skates, bicycles, surfboards, water skis, jet skis, diving equipment, ropes, chains, goggles and/or blankets. In some embodiments, the article of clothing is a sporting accessory, including, but not limited to, a blanket. In some embodiments, the garment is configured for use in orthopedic applications, including, but not limited to, the orthopedic garment, footwear, and the like. In some cases, the garment is a patch (eg a patch that is made to adhere to the skin or not, such as transdermal patches, transdermal hydrogel patches, etc.), adhesive tape, such as kinesio, non-adhesive tape, fillers or bandages or padded materials (pads), insoles, bedding, including a sheet, a mattress, a blanket, a pillow, and/or a pillowcase, a body support, a foam roller, a lotion, a soap, tape, glassware, furniture, paint, paint, a label, rug, a mat, a food and/or beverage container, a beverage insulator (eg bottle or can), headgear (by example, a helmet, a hat, etc.), footwear (eg a shoe, sneakers, sandal, etc.), a headset, a surface, a sports surface, synthetic grass, and the like. In some cases, the article of clothing is a shirt, pants, shorts, dresses, a skirt, jacket, a hat, an underwear, a sock, a cap, a glove, a scarf, a diaper, a blanket, a duvet, a duvet cover, a mattress and the like. In another embodiment, the article is a body support selected from a body support selected from a knee strap, an elbow support, a compression arm sleeve, a compression leg sleeve, a wrist and the like.
[0094] In some embodiments, the subject described herein provides from 1 joule/cm2 to 45 joules/cm2, from 2 to 10 joules/cm2 or from 4 to 6 joules/cm2 of far infrared energy rays or rays for an individual. In certain embodiments, the bioceramic formulation provides at least 1 joule/cm2, 1.5 joule/cm2, at least 2 joules/cm2, at least 3 joules/cm2, at least 4 joules/cm2, at least 5 joules/cm2 , at least 6 joules/cm2, at least 7 joules/cm2, at least 8 joules/cm2, at least 9 joules/cm2, at least 10 joules/cm2, at least 11 joules/cm2, at least 12 joules/cm2, at least at least 13 joules/cm2, at least 14 joules/cm2, at least 15 joules/cm2, at least 16 joules/cm2, at least 17 joules/cm2, at least 18 joules/cm2, at least 19 joules/cm2, at least 20 joules/cm2 , at least 21 joules/cm2, at least 22 joules/cm2, at least 23 joules/cm2, at least 24 joules/cm2, at least 25 joules/cm2, at least 26 joules/cm2, at least 27 joules/cm2, at least 28 joules /cm2, at least 29 joules/cm2, at least 30 joules/cm2, at least 31 joules/cm2, at least 32 joules/cm2, at least 33 joules/cm2, at least 34 joules/cm2, at least 35 joules/cm2, at least 36joules/cm2, at least 3 7 joules/cm2, at least 38 joules/cm2, at least 39 joules/cm2, at least 40 joules/cm2, at least 41 joules/cm2, at least 42 joules/cm2, at least 43 joules/cm2, at least 44 joules/cm2 or about 45 joules/cm2 of energy or far-infrared rays to an individual.
[0095] In some cases, a revelation garment can provide a maximum of 1.5 joules/cm2, a maximum of 2 joules/cm2, a maximum of 3 joules/cm2, a maximum of 4 joules/cm2, a maximum of 5 joules/ cm2, maximum 6 joules/cm2, maximum 7 joules/cm2, maximum 8 joules/cm2, maximum 9 joules/cm2, maximum 10 joules/cm2, maximum 11 joules/cm2, maximum 12 joules/cm2 , maximum 13 joules/cm2, maximum 14 joules/cm2, maximum 15 joules/cm2, maximum 16 joules/cm2, maximum 17 joules/cm2, maximum 18 joules/cm2, maximum 19 joules/cm2, maximum 20 joules/cm2, maximum 21 joules/cm2, maximum 22 joules/cm2, maximum 23 joules/cm2, maximum 24 joules/cm2, maximum 25 joules/cm2, maximum 26 joules/cm2, no maximum 27 joules/cm2, maximum 28 joules/cm2, maximum 29 joules/cm2, maximum 30 joules/cm2, maximum 31 joules/cm2, maximum 32 joules/cm2, maximum 33 joules/cm2, maximum 34 joules/cm2, maximum 35 joules/cm2, maximum 36 joules/cm2, maximum 37 joules/cm2, maximum 38 joules/cm2, maximum 39 joules/cm2, maximum 40 joules/cm2, maximum 41 joules/cm2, maximum 42 joules/cm2, maximum 43 joules/cm2, maximum 44 joules/cm2 or maximum 45 joules/cm2 /cm2 of energy or far infrared rays for an individual.
[0096] In some cases, an article of clothing of the revelation provides between 1.5 joule/cm2 and 45 joules/cm2, between 1.5 joule/cm2 and 40 joules/cm2, between 1.5 joule/cm2 and 35 joules /cm2, between 1.5 joule/cm2 and 30 joules/cm2, between 1.5 joule/cm2 and 25 joules/cm2, between 1.5 joule/cm2 and 20 joules/cm2, between 1.5 joule/cm2 and 15 joules/cm2, between 1.5 joules/cm2 and 10 joules/cm2, between 1.5 joules/cm2 and 5 joules/cm2, between 2 joules/cm2 and 45 joules/cm2, between 2 joules/cm2 and 40 joules /cm2, between 2 joules/cm2 and 35 joules/cm2, between 2 joules/cm2 and 30 joules/cm2, between 2 joules/cm2 and 25 joules/cm2, between 2 joules/cm2 and 20 joules/cm2, between 2 joules /cm2 and 15 joules/cm2, between 2 joules/cm2 and 10 joules/cm2, between 2 joules/cm2 and 5 joules/cm2 of energy or far infrared rays for an individual. In some cases, the device is a shirt, and the shirt provides a maximum of 45 joules/cm2 of energy or far-infrared rays for an individual.
[0097] Infrared energy can be absorbed, reflected or emitted by molecules. In many cases, thermal radiation emitted by objects at or near ambient temperature (approximately 25 °C) is infrared.
[0098] For example, in certain applications of the subject described in the present invention, infrared energy is emitted or absorbed by molecules through rotational and/or vibrational movements. In certain embodiments, the bioceramic materials provided in the present invention that provide infrared energy elicit vibrational modes in a molecule through a change in dipole moment. In some embodiments, heat absorption by a bioceramic of the present disclosure causes vibrational modes in at least one molecule of the bioceramic through changes in dipole moment. Furthermore, the infrared energy from thermal radiation, in certain modalities, is absorbed and reflected by molecules in the bioceramics when they change their rotational-vibrational energy. In extra or additional embodiments, there is provided in the present invention a bioceramic comprising a formulation of a ceramic material and vibrational technology that provides enhanced biomodulatory properties when in contact with or applied to a subject, including as an example of a human subject. Articles
[0099] One aspect of the articles, subject compositions, methods, devices and systems described in the present invention is an article comprising a composition comprising a bioceramic, provided that, when heated or exposed to heat, the bioceramic provides a biomodulating or physiological when the article is applied to an individual.
[0100] In some embodiments, articles are provided that incorporate a composition of bioceramics, and articles with bioceramics applied to them. In one embodiment, the bioceramic composition is present as a coating on at least a portion of the surface of the article (e.g., on the inside or outside of the article) or is directly incorporated into a substrate before or during fabrication of the article itself. In another embodiment, the substrate is a polymeric material, fabric or metallic material.
[0101] In some embodiments, bioceramic compositions are provided that further comprise a substrate, a binder, a solvent, a polymer or a paint. In some embodiments, a bioceramic composition is provided that further comprises a substrate that comprises at least one elastomer. In some embodiments, a bioceramic composition is provided which further comprises a polymer that is selected from the group consisting of polyoxybenzylmethylenglycol anhydride, polyvinyl chloride, polystyrene, polyethylene, polypropylene, polyacrylonitrile, polyvinyl butyral, polylactic acid and combinations thereof. In extra or additional embodiments, a bioceramic composition is provided containing an elastomer which is selected from the group consisting of polychloroprene, nylon, a polyvinyl chloride elastomer, a polystyrene elastomer, a polyethylene elastomer, a polypropylene elastomer, an elastomer of polyvinyl butyral, silicone, a thermoplastic elastomer and combinations thereof.
[0102] In some embodiments, an article is provided that contains a bioceramic composition that further comprises a substrate comprising a material selected from the group consisting of wool, silk, cotton, canvas, jute, glass, nylon, polyester, acrylic, spandex , polychloroprene, laminated fabrics containing expanded polytetrafluoroethylene and combinations thereof. In still further or additional embodiments, an article containing a bioceramic composition which further comprises a polygel is provided.
[0103] For example, in one embodiment, a polymeric article is prepared by mixing a bioceramic composition with the polymeric substrate, or alternatively applying the bioceramic to the substrate while the substrate is in a liquid or fluid form. In some embodiments, the amount of bioceramic composition incorporated into the polymeric substrate or applied to the substrate can be any suitable amount that reflects a sufficient amount of far infrared energy. In one embodiment, the bioceramic composition is added in an amount from about 1% by weight to about 75% by weight by total weight of the article. In another embodiment, the bioceramic composition is added in an amount of from about 0.01% by weight to about 25% by weight by total weight of the article. In yet another embodiment, the bioceramic composition is added in an amount of from about 3% by weight to about 20% by weight by total weight of the article. In a further embodiment, the bioceramic composition is added in an amount of from about 7% by weight to about 13% by weight by total weight of the article. In another embodiment, the polymeric substrate is in the form of a fabric substrate, such as a jacket, which is discussed in more detail below.
[0104] The polymeric substrate includes any polymer that is useful for preparing an article. For example, the polymeric substrate includes at least one elastomeric polymer or at least one non-elastomeric polymer. As bonded polymers and polymeric systems, polymer blends that include continuous and/or dispersed phases, and the like.
[0105] Elastomers include, but are not limited to, viscoelastic polymers such as, for example, natural rubbers, synthetic rubbers, rubber-like and elastic polymeric materials. An example of a synthetic rubber is polychloroprene (Neoprene). In one embodiment, the elastomer is selected from polychloroprene, nylon, a polyvinyl chloride elastomer, a polystyrene elastomer, a polyethylene elastomer, a polypropylene elastomer, a polyvinyl butyral elastomer, silicone, a thermoplastic elastomer, and combinations thereof .
[0106] Thermoplastic elastomers (TPEs) are composite materials obtained from the combination of an elastomeric material and a thermoplastic material. TPEs are elastomeric materials that are dispersed and crosslinked in a continuous phase of a thermoplastic material. Examples of conventional TPEs are Santoprene®, available from Advanced Elastomers Systems, Inc., and Sarlink®, available from DSM Elastomers, Inc.
[0107] In one embodiment, the non-elastomer is selected from a group of polymers including, but not limited to, polyoxybenzylmethylenglycol anhydride, polyvinyl chloride, polystyrene, polyethylene, polypropylene, polyacrylonitrile, polyvinyl butyral, polylactic acid and the like.
[0108] In relation to an article that includes a fabric substrate and a bioceramic composition, the bioceramic composition can be applied to the fabric by any process known in the cloth/fabric art using a liquid or fluid vehicle containing the fabric composition. bioceramics. For example, a silk-screen printing process, a dot application process, a binder solution application process, a visible repeat pattern process, or any other suitable method can be used. Silkscreen printing is a printing process that uses a shape - referred to as a frame or sieve - that includes a fabric with a very fine mesh, which is permeable to ink in the areas of the image to be reproduced and impermeable in other areas. A stitch application process uses specific devices, such as a syringe comprising a bioceramic, to apply the ceramic to particular portions of an article of clothing. A binding solution application process is used to dip tissues into solutions or pastes that comprise the bioceramic - in some cases this is used to impregnate the tissue with a bioceramic. A visible repeat pattern process is used to add a single pattern or repeats of a pattern to an article of clothing. In one embodiment, the bioceramic composition can be incorporated into an ink, which is then screen-printed on at least a portion of the surface of the fabric substrate.
[0109] In another embodiment, the bioceramic composition is combined with one or more liquid polymers (eg polyester and/or the like). The bioceramic/polymer composition is then extruded using methods known in the art to form fibers that are used in preparing a fabric substrate.
[0110] Fabric substrates useful in the present invention include fabric or textile substrates prepared by any method known to a person skilled in the art of fabric manufacturing. Such techniques include, but are not limited to, weaving, knitting, crochet, felting, knitting, gluing and the like. Suitable starting materials for fabric substrates include natural or synthetic (e.g. polymeric) fibers and filaments. In one embodiment, the fabric substrate includes, but is not limited to, a material selected from wool, silk, cotton, canvas, jute, glass, nylon, polyester, acrylic, spandex, polychloroprene, laminated fabrics containing expanded polytetrafluoroethylene ( eg Gore-Tex® fabric) and combinations thereof.
[0111] In relation to an article that includes a metallic substrate, the bioceramic composition is optionally applied to the metal in a liquid/fluid form by any process known in the metal processing art. For example, the bioceramic composition is optionally incorporated into a liquid/fluid vehicle, such as, but not limited to, a paint, sealant, varnish and the like, and applied to at least a portion of the surface of the metal substrate. The amount of bioceramic composition added to a paint or other liquid/fluid vehicle can be any suitable amount. Suitable metal substrates for use in the present invention include any metal substrate that is useful for preparing an article that incorporates a bioceramic composition. Exemplary metal substrates include alloys and pure metals. In one embodiment, the metallic substrate is selected from zinc, molybdenum, cadmium, scandium, titanium, vanadium, chromium, manganese, iron, cobalt, nickel, copper, zirconium, niobium, ruthenium, rhodium, palladium, silver, tantalum, tungsten, rhenium, osmium, iridium, platinum, gold, aluminum, gallium, indium, tin, and the like. article of clothing
[0112] Virtually any article that a bioceramic composition can be applied to or incorporated into is suitable. In one embodiment, the article is selected from an article of clothing (e.g., an article of clothing, such as: jewelry, patches (e.g., patches that are made to adhere to the skin, such as transdermal patches, transdermal hydrogel patches, etc.). ), adhesive tape, such as kinesio, non-adhesive tape, fillings or bandages and padded materials, insoles, performance sleeves, uniforms, casual/leisure clothing, bedding, including sheets, mattresses, covers, pillows and pillowcases, supports for the body, supports, foam rollers, lotions, soaps, tapes, glassware, furniture, paints, paints, labels, rugs, mats, food and/or beverage containers, beverage insulators (eg bottle or can ), headgear (eg helmets, hats, etc.), footwear (eg shoes, sneakers, sandals, etc.), headphones, a surface, a sports surface, artificial grass and the like.
[0113] In some embodiments, the article of clothing includes an article of sporting apparel, sporting accessories and sports equipment including, but not limited to, an orthopedic article of apparel, athletic shoes, uniforms, footwear, insoles, performance sleeves, clothing diving gear, life jackets, shirts, shorts, bracelets, armbands, headgear (eg caps), headbands, gloves, jackets, pants, hats and backpacks, skis, ski poles, snowboards, skateboards , inline skates, bicycles, surfboards, water skis, jet skis, diving equipment, ropes, chains, goggles and blankets. In some embodiments, the article of clothing comprises sporting accessories, including, but not limited to, blankets. In some embodiments, the garment is configured for use in orthopedic applications, including, but not limited to, the orthopedic garment, footwear, and the like.
[0114] In another modality, the article is an article of clothing selected from shirts, pants, shorts, dresses, skirts, jackets, hats, underwear, socks, caps, gloves, scarves, diapers and the like. In yet another modality, the item is a jewelry selected from bracelets, necklaces, earrings, medallions, pendants, rings and similar. In yet another modality, the item is bedding selected from blankets, sheets, pillows, pillow cases, duvet covers, duvet covers, mattress covers, mattress protectors and the like. In another embodiment, the article is a body support selected from knee wraps, elbow supports, arm compression sleeves, leg compression sleeves, wrist wraps, and the like. In some embodiments, the article of clothing includes leisure/casual clothing.
[0115] In extra or additional embodiments, an article is provided that incorporates a bioceramic composition, or an article with bioceramic applied to it, provided that the article is selected from the group consisting of an article of clothing, jewelry, plasters, fillers or dressings or padded materials, insoles, bedding, body supports, foam rollers, lotions, soaps, ribbons, glass items, furniture, paints, paints, labels, rugs, mats, food and/or beverage containers, insulators for beverages, headgear, footwear, headphones and combinations thereof. In extra or additional embodiments, the article comprises article of clothing such as clothing. In some embodiments, the garment is a casual/leisure garment garment. In some embodiments, the article of clothing is an article of sporting apparel. In some embodiments, the article of clothing comprises a shirt, jacket, shorts or trousers. In still other embodiments, the article of clothing comprises a wristband, a padding or bandage or quilting material, a knee brace, an anklet, a sleeve, a performance sleeve, headgear (e.g., cap), a plaster, shoes or insoles.
[0116] In some modalities, the article is a surface, a sports surface or synthetic grass. Biomodulation Effect
[0117] Another aspect of the articles, subject compositions, methods, devices and systems described herein is a bioceramic composition that provides a biomodulatory or physiological effect when it is heated or exposed to heat, such as human radiation. In some modalities, the biomodulatory or physiological effect comprises: pain modulation, increased muscle endurance, increased vigor, increased muscle strength, modulation of the cardiorespiratory system, such as an increase in respiratory capacity, increased flexibility, a modulation of cell metabolism , an improvement in analgesia, an antioxidative effect, an antifibromyalgia effect, a decrease in inflammation, a decrease in oxidative stress, a modulation of cytokine levels, a modulation of blood circulation, a reduction in intolerance to a cold environment, a reduction in a symptom of arthritis or vascular disease, an increase in skin perfusion, a decrease in heart rate, a decrease in blood pressure, faster recovery from injury or exercise, an aesthetic effect such as a reduction in the individual's cellulite, and an improvement in the quality of life.
[0118] A developing bioceramic composition has a biomodulatory or physiological effect on various individuals. In some embodiments, individuals are humans, non-human primates such as chimpanzees, and other primate and monkey species; farm animals such as cattle, horses, sheep, goats and swine; domestic animals such as rabbits, dogs and cats; laboratory animals, including rodents such as rats, mice and guinea pigs; and the like. An individual can be of any age. In some modalities, individuals are, for example, elderly adults, adults, teenagers, pre-teens, children, young children and infants.
[0119] In some modalities, the biomodulatory or physiological effect is a change in body composition. A body composition can be described in terms of body mass index, fat mass index, skeletal muscle mass index, body fat percentage, or any combination of these. Various methods can be used to measure body composition, such as bioimpedance analysis. A bioimpedance analyzer can be used in a bioimpedance analysis to calculate an estimate of total body water (TBW). TBW can be used to estimate fat-free body mass and, by difference with body weight, body fat.
[0120] In some embodiments, the biomodulatory or physiological effect is an increase or decrease in the level of expression of a biomarker. Biomarkers broadly refer to any characteristics that are objectively measured and evaluated as indicators of normal biological processes, normal muscle function, pathogenic processes, or pharmacological responses to bioceramics. Unless otherwise indicated, the term biomarker as used in the present invention refers specifically to biomarkers that have biophysical properties that allow their measurements in biological samples (e.g., saliva, plasma, serum, cerebrospinal fluid, lavage bronchoalveolar and biopsy). Examples of biomarkers include nucleic acid biomarkers (oligonucleotides or polynucleotides), peptides or protein biomarkers, cytokines, hormones or lipids. In some embodiments, an article comprising a bioceramic composition of the disclosure has a biomodulatory or physiological effect on a biomarker.
[0121] In some embodiments, a biomarker is a cytokine. Non-limiting examples of cytokines include: a) cytokines from the IL-2 subfamily, for example, erythropoietin (EPO) and thrombopoietin (TPO); b) the interferon subfamily (IFN), for example IFN-Y; c) the IL-6 subfamily; d) the IL-10 subfamily; e) the IL-1 subfamily, for example, IL-1 and IL-18, f) IL-17; or g) the tumor necrosis factor family, for example tumor necrosis factor alpha (TNF-alpha or TNF-α). In some embodiments, an article comprising a bioceramic composition of the disclosure has a biomodulatory or physiological effect on a cytokine. In some embodiments, the cytokine is associated with inflammation, pain, muscle endurance, a modulation of the cardiorespiratory system, a modulation of cell metabolism, analgesia, cell oxidation, fibromyalgia effect, or other condition described in the present invention.
[0122] In some embodiments, a biomarker is a wild-type protein or a protein that has been modified from a native state. For example, protein carbonylation is a type of protein oxidation that can be promoted by reactive oxygen species. It generally refers to a process that forms reactive ketones or aldehydes that are favorable to react with 2,4-dinitrophenylhydrazine (DNPH) to form hydrazones. Direct oxidation of the side chains of lysine, arginine, proline and threonine residues, among other amino acids, in the “primary protein carbonylation” reaction produces detectable protein products of DNPH. In some embodiments, an article comprising a bioceramic composition of the disclosure has a biomodulatory or physiological effect on a protein. In some embodiments, the protein is associated with inflammation, pain, muscle endurance, a modulation of the cardiorespiratory system, a modulation of cell metabolism, analgesia, cell oxidation, fibromyalgia effect, or other condition described in the present invention.
[0123] In some embodiments, a biomarker is a wild-type lipid or a lipid that has been modified from a native state. For example, lipid peroxidation refers to the oxidative degradation of lipids. It is the process in which free radicals remove electrons from lipids in cell membranes, resulting in cell damage. In some embodiments, an article comprising a bioceramic composition of the disclosure has a biomodulating or physiological effect on a lipid. In some embodiments, lipid is associated with inflammation, pain, muscle endurance, a modulation of the cardiorespiratory system, a modulation of cell metabolism, analgesia, cell oxidation, fibromyalgia effect, or other condition described in the present invention.
[0124] In some embodiments, the composition of bioceramics provides a biomodulatory or physiological effect that comprises a change that is statistically significant. In extra or additional embodiments, the biomodulatory or physiological effect comprises a change that is at least 5% of the effect. In some embodiments, the biomodulatory or physiological effect comprises a change that is at least 10% of the effect. In still other extra or additional modalities, the biomodulatory or physiological effect is pain relief, and the pain is caused by physical activity. In still other extra or additional modalities, the biomodulatory or physiological effect is inflammation.
[0125] The time required for a developing bioceramic to modulate the effect of a biomarker generally depends on the predominant amount, distribution and concentration of the bioceramic in contact with the individual. In some embodiments, a biomodulating or physiological effect of a developing bioceramic is achieved in less than 10 minutes, less than 1 hour, less than 6 hours, less than 12 hours, less than 24 hours, less than 48 hours, less than 72 hours, less than 1 week, less than 2 weeks, less than 3 weeks, less than 4 weeks, less than 2 months, less than 6 months, or less than 12 months of a use of an article of clothing comprising a bioceramic. Adjunctive therapies
[0126] A bioceramic of revelation can provide numerous therapeutic benefits to an individual wearing an article of clothing comprising the bioceramic. Far infrared energy provided by a bioceramic can be helpful in improving blood circulation, reducing pain, strengthening the cardiovascular system, relieving joint stiffness and inflammation, and revitalizing skin cells. Far infrared energy can provide an analgesic effect for the individual. Examples described in this disclosure provide qualitative and quantitative metrics of a bioceramic on various physiological parameters. Also, in some cases, a bioceramic garment may comprise another active compound. In other cases, a treatment regimen that utilizes a bioceramic may be given along with adjuvant therapy.
[0127] A bioceramic can be formulated with another compound/active substance. In some cases, a bioceramic is formulated with a pharmaceutically active or inactive compound that provides a desired smell, feel or texture. For example, an article of clothing, for example a plaster, can be formulated with one or more additional active or inactive substances. The one or more other substances can be, for example, menthol, cinnamon, peppermint, cayenne pepper (capsaicin), camphor, mustards, medicinal herbs, compounds derived from such herbs or substitutes thereof. The ratio of agent (e.g. bioceramic) to another substance may be at least 100:1, 95:1, 90:1, 85:1, 80:1, 75:1, 70:1, 65:1 , 60:1, 55:1, 50:1, 45:1, 40:1, 35:1, 30:1, 25:1, 20:1, 15:1, 10:1, 5:1, 2 :1, 1:1, 1:2, 1:5, 1:10, 1:15, 1:20, 1:25, 1:30, 1:35, 1:40, 1:45, 1:50 , 1:55, 1:60, 1:65, 1:70, 1:75, 1:80, 1:85, 1:90, 1:95 or 1:100.
[0128] In some cases, a bioceramic composition may have an analgesic effect on an individual wearing an article of clothing, eg plaster, shirt, shorts, etc., comprising the bioceramic. In some cases, the analgesic effect is exclusively provided by the bioceramic and the additional substance. A plurality of dosages of active substances such as menthol, cinnamon, peppermint, cayenne (capsaicin), mustards, medicinal herbs, compounds derived from such herbs or substitutes thereof may be incorporated into an article of clothing of the disclosure. Non-limiting examples of medicinal herbs and exemplary species include açaí (Euterpe oleracea), alfalfa (Medicago sativa), aloe vera (eg, Aloe barbadensis), arnica (Arnica montana), mastic (Schinus terebinthifolius), Açoca (Saraca indica) , blackberry (Euphorbia hirta), astragalus (Astragalus propinquus), barberry (Berberis vulgaris), belladonna (Atropa belladona), blueberry (Vaccinium myrtillus), melon (Momordica charantia), vernonia (Vernonia amygdalina), bitter orange (Citrus x aurantium), boswellia (Boswellia serrata), acacia or St. Kitts grass (Actaea racemosa), holy thistle (Cnicus benedictus), blueberries (genus Vaccinium), burdock (Arctium lappa), wild tobacco (Solanum mauritianum), cat's claw (Uncaria tomentosa), pepper (Capsicum annuum), celery (Apium graveolens), chamomile (eg Matricaria recutita and Anthemis nobilis), chaparral (Larrea tridentata) vitex (Vitex agnus-castus), chili pepper (Capsicum frutescens), chi na (a genus of about 38 species of trees whose bark is a source of alkaloids, including quinine), cloves (Syzygium aromaticum), pine (Cassia occidentalis), comfrey (Symphytum officinale), cranberry or cranberry (Vaccinium macrocarpon), dent- dandelion (Taraxacum officinale), foxglove (Digitalis lanata), angelica or Dong quai (Angelica sinensis), elderberry (Sambucus nigra), ephedra (Ephedra sinica), eucalyptus (Eucalyptus globulus), mistletoe (Viscum album), evening primrose (Oenothera spp.), fenugreek (Trigonella foenum-graecum), feverfew (Tanacetum parthenium), flaxseed (Linum usitatissimum), garlic (Allium sativum), ginger (Zingiber officinale), Ginkgo (Ginkgo biloba), ginseng (Panax ginseng and Panax quinquefolius), goldenseal (Hydrastis canadensis), green tea (Camellia sinensis), grape (Vitis vinifera), guava (Psidium guajava), hawthorn (specifically Crataegus monogyna and Crataegus laevigata), henna (Lawsonia Inermis), hoodnii (Hoodia gordonii) ), horse chestnut (Aesculus hippocastanu m), horsetail (Equisetum arvense), timbó (Piscidia erythrina/Piscidia piscipula), lavender (Lavandula angustifolia), lemon (Citrus limon), licorice root (Glycyrrhiza glabra), lotus (Nelumbo nucifera), marigold (Calendula officinalis), marshmallow (Althaea officinalis), noni (Morinda citrifolia), poppy (Papaver somniferum), oregano (Origanum vulgare), peppermint (Mentha x piperita), polygala (Paniculata L), podofilox (podofilox), fava-de-de sucupira (Pterodon emarginatus), summer savory (Satureja hortensis), God's thunder vine (Tripterygium wilfordii), turmeric (Curcuma longa), willow bark (Salix alba) and white willow (Salix alba).
[0129] In some cases, a bioceramic composition may have an anti-inflammatory effect on an individual wearing an article of clothing, eg plaster, shirt, shorts, etc. comprising bioceramics. In some cases, the anti-inflammatory effect is provided by a combination of bioceramic and an additional substance. A plurality of dosages of anti-inflammatory substances can be incorporated into an article of clothing of the disclosure. Non-limiting examples of exemplary substances, medicinal herbs of origin and species that can provide an anti-inflammatory effect include alfalfa (Medicago sativa L.), aloe vera gel (Aloe Vera gel, Aloe vera), andiroba oil (Carapa guianensis ), Indian ginseng (Withania somnifera), Gilead balm (Populus spp), Peruvian balsam (Myroxylon pereirae), barberry (Berberis vulgaris L.), barley grass (Hordeum vulgare), blueberry (Vaccinium myrtillus), bark and leaf of birch (Betula alba), black sesame oil (Nigella sativa), eupatorium (Eupatorium perfoliatum), borage seed oil (Borago officinalis), boswellia (Frankincense), boswellia (Frankincense), Boswellia thurifera, Bupleurum chin , marigold (Calendula officinalis), cat's claw (Uncaria tomentosa), chamomile (Matricaria recutita), chickweed (Stellaria media), chicory root (Cichorium intybus), chrysanthemum (Chrysanthemum morifolium, C. sinense), coriander (Coriandrum sativu m), copaiba balsam (Copaifera Officinalis), coptis (Coptis spp), corn silk (Zea mays), brush (Centaurea cyanus), cumin (Cuminum cyminum), devil's claw (Harpagophytum procumbens), flower cone (Echinacea angustifolia), feverfew (Tanacetum parthenium), scrofularia (Scrophularia nodosa), ginkgo biloba (Ginkgo biloba L.), Grindelia (Grindelia spp), immortelle oil (Helichrysum angustifolium), jamaican dogwood (Piscipis), marshmallow (Eupatorium purpureum), marshmallow root (Althaea officinalis L.), mullein (Verbascum spp.), oats (Avena sativa L.), Oregon grape root (Mahonia aquifolium), pineapple (Ananas comosus), sarsaparilla root (Smilax sarsaparilla), sea buckthorn oil (Hippophae rhamnoides), shea butter (Butyrospermum parkii), saponaria (Saponaria officinalis), spinach (Aralia racemosa), watercress (Spilanthes acmella), tamanu oil Calophyllum inophyllum), turmeric (Curcuma longa L.), white peony root (Paeon ia albiflora), white willow bark (Salix Alba), wild cherry bark (Prunus serotina), witch hazel (Hamamelis virginiana), yarrow (Achillea millefolium) and yucca root (Yucca spp).
[0130] In some cases, the active substance is an analgesic. In some cases, the plurality of dosages is from about 1 mg to about 2000 mg; from about 5 mg to about 1000 mg, from about 10 mg to about 25 mg to 500 mg, from about 50 mg to about 250 mg, from about 100 mg to about 200 mg, from about 1 mg to about 50 mg, from about 50 mg to about 100 mg, from about 100 mg to about 150 mg, from about 150 mg to about 200 mg, from about 200 mg to about 250 mg, from about 250 mg to about 300 mg, from about 300 mg to about 350 mg, from about 350 mg to about 400 mg, from about 400 mg to about 450 mg, from about 450 mg to about 500 mg, from about 500 mg to about 550 mg, from about 550 mg to about 600 mg, from about 600 mg to about 650 mg, from about 650 mg to about 700 mg , from about 700 mg to about 750 mg, from about 750 mg to about 800 mg, from about 800 mg to about 850 mg, from about 850 mg to about 900 mg, from about 900 mg to about 950 mg or from about 950 mg to about 1000 mg. In some cases, the plurality of events is administered to an individual with a treatment regimen that occurs over a period of time. The time period can be about at least or at most 30 seconds, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 minutes.
[0131] In addition to the benefits of using garments comprising bioceramics alone, individuals can combine additional treatment regimens with the use of a bioceramic garment as adjuvant therapies. For example, physiotherapy can be used as an adjunctive therapy treatment to a bioceramics treatment regimen. Other examples of adjunctive therapies include physical therapy, physical rehabilitation, hydrotherapy, pilates or other suitable complementary therapy.
[0132] An adjunctive therapy regimen may be prescribed to an individual concurrently or concurrently with a therapy regimen involving a use of a bioceramic garment. An adjunctive therapy regimen can be performed in many settings, such as in an individual's home, in fitness centers and sports training facilities, in outpatient clinics or offices, in health and wellness clinics, in rehabilitation hospital facilities. , in nursing facilities, in long-term care facilities, in private homes, in training and research centers, in schools, hospitals, workplaces or other settings. Non-invasive methods of providing biomodulation to an individual
[0133] Another aspect of the subject described in the present invention is a non-invasive method of providing a physiological or biomodulatory effect in or to an individual, which comprises contacting an article, comprising a bioceramic, with the individual's skin, provided that, when heated or exposed to heat, the bioceramic composition provides far infrared thermal radiation and a biomodulating or physiological effect to the individual in a non-invasive manner.
[0134] For example, in some embodiments, a bioceramic composition is provided which, when heated or exposed to heat, provides a physiological or biomodulatory effect when the article is applied to an individual, comprising: a. about 20% by weight to about 80% by weight kaolinite (Al2Si2O5(OH)4); b. about 1% by weight to about 30% by weight tourmaline; c. about 1% by weight to about 40% by weight aluminum oxide (Al2O3); d. about 1% by weight to about 40% by weight silicon dioxide (SiO2); and is. about 1% by weight to about 20% m and weight of zirconium oxide (ZrO2); provided the amounts are by the total weight of the bioceramic composition.
[0135] In extra or additional embodiments, a bioceramic composition of matter is provided which, when heated or exposed to heat, provides a physiological or biomodulating effect when the article is applied to an individual, comprising: a. about 40% by weight to about 60% by weight kaolinite (Al2Si2O5(OH)4); b. about 5% by weight to about 15% by weight of tourmaline; c. about 15% by weight to about 25% by weight aluminum oxide (Al2O3); d. about 10 wt% to about 20 wt% silicon dioxide (SiO2); and is. about 1% by weight to about 20% m and weight of zirconium oxide (ZrO2); provided the amounts are by the total weight of the bioceramic composition. In some embodiments, the bioceramic composition comprises kaolinite in a range of from about 45% by weight to about 55% by weight. In extra or additional embodiments, a bioceramic composition comprising kaolinite, in the range of from about 47% by weight to about 53% by weight, is provided. In extra or additional embodiments, a bioceramic composition is provided which contains kaolinite in a range of about 48% by weight to about 52% by weight.
[0136] In some embodiments, a bioceramic composition comprising it is provided. about 50% by weight of kaolinite (Al2Si2O5(OH)4); b. about 10% tourmaline by weight; c. about 18% by weight aluminum oxide (Al2O3); d. about 14% by weight silicon dioxide (SiO2);ee. about 8% by weight of zirconium oxide (ZrO2).
[0137] In some modalities, the biomodulatory or physiological effect comprises: a modulation of pain, an increase in muscle endurance, a modulation of the cardiorespiratory system, a modulation of cell metabolism, analgesia, antioxidative effect, an antifibromyalgia effect, a decrease in inflammation , a decrease in oxidative stress, a decrease in endoplasmic reticulum stress, a modulation of cytokine levels, a modulation of blood circulation, a reduction in intolerance to a cold environment, a reduction in a symptom of arthritis or vascular disease, an increase of skin perfusion, a decrease in heart rate, a decrease in blood pressure, an aesthetic effect such as a reduction in body size, weight reduction or a decrease in the individual's cellulite.
[0138] In some embodiments, the bioceramic composition provides a biomodulatory or physiological effect that comprises a change that is statistically significant. In extra or additional embodiments, the biomodulatory or physiological effect comprises a change that is at least 5% of the effect.
[0139] In some embodiments, an article is provided that incorporates a bioceramic composition, or an article with bioceramic applied to it, provided the article is selected from the group consisting of an article of clothing, jewelry, plasters, fillers or dressings or padded material, insoles, bedding, body supports, foam rollers, lotions, soaps, ribbons, glassware, furniture, paints, paints, labels, rugs, mats, food and/or beverage containers, insulators for beverages, headgear, footwear, headphones and combinations thereof. In extra or additional embodiments, the article comprises article of clothing such as clothing. In some embodiments, the article of clothing comprises a shirt, jacket, shorts or trousers. In still other embodiments, the article of clothing comprises a wristband, a padding or bandage or padding material, a knee brace, an anklet, a sleeve or a patch. In some embodiments, the article comprises a surface, a sports surface or synthetic grass.
[0140] A bioceramic composition of the invention can be a combination of any compounds described herein with other chemical components, such as vehicles, stabilizers, diluents, dispersing agents, suspending agents, thickening agents and/or excipients. Bioceramics can be administered directly or indirectly to an individual's skin. In some cases, active compounds can be applied to an article and exposed to an individual indirectly. In other cases, the active compounds can be applied directly to an individual's skin. Manufacturing Methods
[0141] Another aspect of the subject described in the present invention is a method of preparing an article, comprising the steps of: a. prepare a bioceramic solution; and b. applying the solution to the article; provided the solution, when applied to the article, comprises from about 20% by weight to about 80% by weight of kaolinite (Al2Si2O5(OH)4); from about 1% by weight to about 30% by weight tourmaline; from about 1% by weight to about 40% by weight aluminum oxide (Al2O3); from about 1 wt% to about 40 wt% silicon dioxide (SiO2); and from about 1% by weight to about 20% by weight of zirconium oxide (ZrO2); provided, in addition, the amounts are by total weight of the bioceramic composition. In extra or additional embodiments, a method for preparing an article is provided which comprises the steps of: a. prepare a bioceramic solution; and b. applying the solution onto the article; since, when heated or exposed to heat, the bioceramics provide a physiological or biomodulating effect when the article is applied to an individual. In extra or additional embodiments, a method of preparing an article is provided, whereby a solution is applied to the article by a spray technique to the interior or exterior of the article. In some embodiments, a solution is applied to the article by a screen printing technique, a stitch application technique, a binder solution application method, a visible repeat pattern approach, or any other suitable method for inside or outside the article. , optionally, with the use of a colorant. In extra or additional modalities, an ink is not used in the method. In some embodiments, a solution is applied to the article by dipping or immersing the article in a solution or slurry. In particular embodiments, the bioceramic solution comprises a polymer. In some embodiments, the polymer comprises a silicone polymer. In extra or additional modalities, a solution is applied to the interior of the article, the exterior of an article or a specific area of the article. In one modality, a solution is applied as small dots in the article.
[0142] For example, in some modalities, bioceramics comprises: a. about 20% by weight to about 80% by weight kaolinite (Al2Si2O5(OH)4); b. about 1% by weight to about 30% by weight tourmaline; c. about 1% by weight to about 40% by weight aluminum oxide (Al2O3); d. about 1% by weight to about 40% by weight silicon dioxide (SiO2); and is. about 1% by weight to about 20% m and weight of zirconium oxide (ZrO2); provided the amounts are by the total weight of the bioceramic composition.
[0143] In extra or additional modalities, a bioceramic composition is provided, comprising: a. about 40% by weight to about 60% by weight kaolinite (Al2Si2O5(OH)4); b. about 5% by weight to about 15% by weight of tourmaline; c. about 15% by weight to about 25% by weight aluminum oxide (Al2O3); d. about 10 wt% to about 20 wt% silicon dioxide (SiO2); and is. about 1% by weight to about 20% m and weight of zirconium oxide (ZrO2); provided the amounts are by the total weight of the bioceramic composition. In some embodiments, the bioceramic composition comprises kaolinite in a range of from about 45% by weight to about 55% by weight. In extra or additional embodiments, a bioceramic composition comprising kaolinite, in the range of from about 47% by weight to about 53% by weight, is provided. In extra or additional embodiments, a bioceramic composition is provided which contains kaolinite in a range of about 48% by weight to about 52% by weight.
[0144] In some embodiments, a bioceramic composition comprising it is provided. about 50% by weight of kaolinite (Al2Si2O5(OH)4); b. about 10% tourmaline by weight; c. about 18% by weight aluminum oxide (Al2O3); d. about 14% by weight silicon dioxide (SiO2);ee. about 8% by weight of zirconium oxide (ZrO2). In some embodiments, the bioceramic composition comprises tourmaline, which comprises NaFe2+3Al6Si6O18(BO3)3(OH)3OH.
[0145] In one modality, the article is an article of clothing selected from shirts, pants, shorts, dresses, skirts, jackets, hats, underwear, socks, caps, gloves, scarves, diapers and the like. In yet another modality, the item is a jewelry selected from bracelets, necklaces, earrings, medallions, pendants, rings and similar. In yet another modality, the item is bedding selected from blankets, sheets, pillows, pillow cases, duvet covers, duvet covers, mattress covers, mattress protectors and the like. In another embodiment, the article is a body support selected from knee straps, elbow supports, elbow supports, compression arm sleeves, compression leg sleeves, wrist wraps and the like.
[0146] In extra or additional embodiments, an article is provided that incorporates a bioceramic composition, or an article with bioceramic applied to it, provided that the article is selected from the group consisting of an article of clothing, jewelry, plasters, fillers or dressings or padded material, insoles, bedding, body supports, foam rollers, lotions, soaps, ribbons, glass items, furniture, paints, paints, labels, rugs, mats, food and/or beverage containers, insulators for beverages, headgear, footwear, headphones and combinations thereof. In extra or additional embodiments, the article comprises article of clothing such as clothing. In some embodiments, the article of clothing comprises a shirt, jacket, shorts or trousers. In still other embodiments, the article of clothing comprises a wristband, a padding or bandage or padding material, a knee brace, an anklet, a sleeve or a patch.
[0147] Optionally, the articles further include one or more additional frequencies printed on the article using a frequency generator, i.e. a signal generating machine that emits an electromagnetic signal (audio or radio waves) at a selected frequency or frequencies (s). Examples of commercially available frequency generators include, but are not limited to, rife machines (eg ProWave 101; F-Scan2; TrueRife F-117; Wellness Pro 2010; Global Wellness; GB4000; GB4000 BCX Ultra; and the like. In general , the frequency generators produce selected frequencies which are then transmitted through a connecting cable to a commercially available frequency printing plate (eg SP9 or SP12 vortex frequency printing plates). the frequency or frequency ranges range from about 0.05 Hz to about 20 MHz. In another mode, the frequency or frequency ranges range from about 5 Hz to about 5 MHz. frequencies range from about 100 Hz to about 0.1 MHz. In another modality, the frequency or frequency range varies from about 1 KHz to about 10 KHz. The article to be printed with the selected frequency or frequencies ) is exposed to fr frequency emitted by the generator. To do this, the article can be placed on the printing plate and exposed to the signal of the selected frequency or frequencies for printing. In one modality, the printing process takes about 5 to 10 minutes per cycle, depending on the number of frequencies to be printed and the printing program selected. In another modality, the printing process takes about 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes or 10 minutes per cycle, depending on the number of frequencies to be printed and the printing program selected. Printed articles can transmit the frequency impressions to a user through contact, along with the waves emitted from the bioceramic composition that is incorporated into the article.
[0148] In some embodiments, the method of manufacturing an article comprising a bioceramic of the disclosure comprises a silicone-based approach. Silicones are normally inert synthetic compounds. A silicone coating is, for example, a paint, paint, oil, film, coating, grease or resin that is screen-printed, sprayed, or otherwise directly applied to a developing article. In some embodiments, a silicone coating is pre-mixed with a bioceramic before being applied to an article of clothing. In some embodiments, a silicone coating is applied over a bioceramic as a film. In some embodiments, a silicone is blended with a concentration of a bioceramic composition, where the blend provides a biomodulating or physiological effect to an individual. In some embodiments, a higher concentration of a bioceramic is blended with a silicone compared to a concentration of a bioceramic that can effectively blend with a paint or gel. In some embodiments, up to 50% more bioceramic is mixed with a silicone compared to a paint or gel.
[0149] In some embodiments, a bioceramic composition of the disclosure is blended at a ratio of about 1 part bioceramic to about 1 part silicone, about 1 part bioceramic to about 2 parts silicone, about 1 part bioceramic to about 3 parts silicone, about 1 part bioceramic to about 4 parts silicone, about 1 part bioceramic to about 5 parts silicone, about 1 part bioceramic to about 6 parts of silicone, about 1 part bioceramic to about 7 parts silicone, about 1 part bioceramic to about 8 parts silicone, about 1 part bioceramic to about 9 parts silicone, about 1 part bioceramic to about 10 parts silicone, about 1 part bioceramic to about 11 parts silicone, about 1 part bioceramic to about 12 parts silicone, about 1 part bioceramic to about 13 parts silicone , about 1 part of bioceramic to about 14 pa Parts of silicone, about 1 part bioceramic to about 15 parts silicone, about 1 part bioceramic to about 16 parts silicone, about 1 part bioceramic to about 17 parts silicone, about 1 part of bioceramic to about 18 parts silicone, about 1 part bioceramic to about 19 parts silicone, about 1 part bioceramic to about 20 parts silicone, about 1 part bioceramic to about 21 parts silicone, about 1 part bioceramic to about 22 parts silicone, about 1 part bioceramic to about 23 parts silicone, about 1 part bioceramic to about 24 parts silicone, about 1 part bioceramic to about 25 parts silicone, about 1 part bioceramic to about 26 parts silicone, about 1 part bioceramic to about 27 parts silicone, about 1 part bioceramic to about 28 parts silicone, about 1 part of bioceramics to about 29 parts of itself licone, about 1 part bioceramic to about 30 parts silicone, about 1 part bioceramic to about 31 parts silicone, about 1 part bioceramic to about 32 parts silicone, about 1 part bioceramic to about 33 parts silicone, about 1 part bioceramic to about 34 parts silicone, about 1 part bioceramic to about 35 parts silicone, or other suitable ratio.
[0150] In some embodiments, a bioceramic composition of the disclosure is blended at a ratio of about 1 part bioceramic to about 1 part silicone, about 2 parts bioceramic to about 1 part silicone, about 3 parts bioceramic to about 1 part silicone, about 4 parts bioceramic to about 1 part silicone, about 5 parts bioceramic to about 1 part silicone, about 6 parts bioceramic to about 1 part of silicone, about 7 parts bioceramic to about 1 part silicone, about 8 parts bioceramic to about 1 part silicone, about 9 parts bioceramic to about 1 part silicone, about 10 parts bioceramic to about 1 part silicone, about 11 parts bioceramic to about 1 part silicone, about 12 parts bioceramic to about 1 part silicone, about 13 parts bioceramic to about 1 part silicone , about 14 parts of bioceramic to about 1 part and silicone, about 15 parts bioceramic to about 1 part silicone, about 16 parts bioceramic to about 1 part silicone, about 17 parts bioceramic to about 1 part silicone, about 18 parts of bioceramic to about 1 part silicone, about 19 parts bioceramic to about 1 part silicone, about 20 parts bioceramic to about 1 part silicone, about 25 parts bioceramic to about 1 part silicone, about 26 parts bioceramic to about 1 part silicone, about 27 parts bioceramic to about 1 part silicone, about 28 parts bioceramic to about 1 part silicone, about 29 parts bioceramic to about 1 part silicone, about 30 parts bioceramic to about 1 part silicone, about 31 parts bioceramic to about 1 part silicone, about 32 parts bioceramic to about 1 part silicone, about 33 parts of bioceramic to about 1 part of silica one, about 34 parts bioceramic to about 1 part silicone, about 35 parts bioceramic to about 1 part silicone, or other suitable ratio.
[0151] In some embodiments, the method of manufacturing an article comprising a developing bioceramics comprises a stitch application approach. In a stitch application fabrication method, a stitch comprising a bioceramic, alone or in combination with a matrix, is applied to an article. In some embodiments, a matrix is, for example, a silicone matrix, a polymer matrix, or a gel matrix. In some embodiments, a polymer matrix is an innocuous support of the bioceramic. In some embodiments, a polymeric matrix plays an active role in determining the amount of infrared energy that is reflected by a bioceramic. In some embodiments, the polymer is adhesive. In some embodiments, a polymer is used to bond a bioceramic composition to tissue.
[0152] Various polymers can be blended with a developing bioceramic and applied to an article, including, for example, silicone, hydrogels such as cross-linked (poly)vinyl alcohol and (poly)hydroxyl ethyl methacrylate, acyl substituted cellulose acetates and alkyl derivatives thereof, partially or completely hydrolyzed alkylenevinyl acetate copolymers, unplasticized polyvinyl chloride, crosslinked polyvinyl acetate homo and copolymers, crosslinked acrylic acid and/or methacrylic acid polyesters, polyvinylalkyl ethers, polyvinyl fluoride, polycarbonate, polyurethane, polyamide, polysulfones, styrene acrylonitrile copolymers, cross-linked (poly)ethylene oxide, poly(alkylenes), (poly)vinylimidazole, (poly)esters, (poly)ethylene terephthalate, polyphosphazenes and chlorosulfonated polyolefins, and combinations of the same. In some embodiments, the polymer comprises ethylene-vinyl acetate.
[0153] In some embodiments, the method of manufacturing an article comprising a bioceramic of the disclosure comprises a binder or solution application approach. In some embodiments, the bioceramic composition is sprayed or dipped into an article, for example, a shirt, dressing, or bandage. In some embodiments, a binder is a film-forming component of a bioceramic paint. In some cases, a binder comprises materials that impart adhesion of the bioceramic to the garment and strongly influence properties such as gloss, durability, flexibility and resilience of the applied bioceramic. In some embodiments, binders include synthetic or natural resins such as alkyls, acrylics, vinylacrylics, vinyl acetate/ethylene (VAE), polyurethanes, polyesters, melamine resins, epoxy or oils.
[0154] Other non-erodible materials suitable for inclusion in an article of clothing with a bioceramic include, for example, proteins such as zein, resilin, collagen, gelatin, casein, silk, wool, polyesters, polyorthoesters, polyphosphoroesters, polycarbonates, polyanhydrides , polyphosphazenes, polyoxalates, polyamino acids, polyhydroalkanoates, polyethylene glycol, polyvinyl acetate, polyhydroxy acids, polyanhydrides, hydrogels including (poly)hydroxyethyl methacrylate, polyethylene glycol, (poly)N-isopropylacrylamide), poly(N-vinyl-2- pyrrolidone), polyvinyl cellulose alcohol, silicone hydrogels, polyacrylamides and polyacrylic acid.
[0155] In some embodiments, the method of manufacturing an article comprising a developing bioceramic comprises a visible repeat pattern process. A method of visible repeating patterns often comprises a first step of printing, screen printing, spraying or using another method to apply a pattern with common ink (without a bioceramic) onto an article of clothing. A visible repeating pattern method often includes a second step of applying a second material, such as a spray, silicone or binder base comprising a bioceramic over the first pattern. A visible repeating pattern method can optionally use any of the aforementioned materials, including silicones, binders and polymers.
[0156] The manufacturing methods described in the present invention are used to apply a bioceramic to a specific location on an article of clothing or on the entire article of clothing. For example, a manufacturing method disclosed in the present invention can be used to apply a bioceramic to an inner side, an outer side, or any interior/exterior combination of an article of clothing. In most embodiments, the application of a bioceramic to an inner side, an outer side, or any interior/exterior combination of an article of clothing does not affect a biomodulatory or physiological effect of a bioceramic.
[0157] In some embodiments, an article of clothing comprises about 5% bioceramic by total weight, about 10% bioceramic by total weight, about 15% bioceramic by total weight, about 20% bioceramic by weight total, about 25% bioceramic by total weight, about 30% bioceramic by total weight, about 35% bioceramic by total weight, about 40% bioceramic by total weight, about 45% bioceramic by weight total, about 50% bioceramic by total weight, about 55% bioceramic by total weight, about 60% bioceramic by total weight, about 65% bioceramic by total weight, about 70% bioceramic by weight total, about 75% bioceramic by total weight, about 80% bioceramic by total weight, about 85% bioceramic by total weight, about 90% bioceramic by total weight, or about 95% bioceramic by weight total.
[0158] In some embodiments, a bioceramic is applied to a portion or the entire surface of the garment. In some cases, a bioceramic composition is applied to more than 1% of the surface area, more than 5% of the surface area, more than 10% of the surface area, more than 15% of the surface area, more than 20% of the surface area , more than 25% of the surface area, more than 30% of the surface area, more than 35% of the surface area, more than 40% of the surface area, more than 45% of the surface area, more than 50% of the surface area, more 55% surface area, more than 60% surface area, more than 65% surface area, more than 70% surface area, more than 75% surface area, more than 80% surface area, more than 85 % surface area, more than 90% surface area, more than 95% surface area, or more than 99% surface area of a garment.
[0159] In some cases, a bioceramic composition is applied to no more than 1% of the surface area, not more than 5% of the surface area, not more than 10% of the surface area, not more than 15% of the surface area, not more than 20% of the surface area, not more than 25% of the surface area, not more than 30% of the surface area, not more than 35% of the surface area, not more than 40% of the surface area, not more than 45% of the surface area, not more than 50% of the surface area, not more than 55% of the surface area, not more than 60% of the surface area, not more than 65% of the surface area, not more than 70% of the surface area, no more than 75% of the surface area, not more than 80% of the surface area, not more than 85% of the surface area, not more than 90% of the surface area, not more than 95% of the surface area or not more than 99% of the surface area surface area of an article of clothing.
[0160] In some cases, a bioceramic composition is applied to about 1% of the surface area, about 2% of the surface area, about 3% of the surface area, about 4% of the surface area, about 5% of the surface area, about 6% of the surface area, about 7% of the surface area, about 8% of the surface area, about 9% of the surface area, about 10% of the surface area, about 11% of the area surface area, about 12% of the surface area, about 13% of the surface area, about 14% of the surface area, about 15% of the surface area, about 16% of the surface area, about 17% of the surface area, about 18% of the surface area, about 19% of the surface area, about 20% of the surface area, about 21% of the surface area, about 22% of the surface area, about 23% of the surface area, about 24% of the surface area, about 25% of the surface area, about 26% of the surface area, about 27% of the surface area , about 28% of the surface area, about 29% of the surface area, about 30% of the surface area, about 31% of the surface area, about 32% of the surface area, about 33% of the surface area, about 34% of the surface area, about 35% of the surface area, about 36% of the surface area, about 37% of the surface area, about 38% of the surface area, about 39% of the surface area, about 40 % of the surface area, about 41% of the surface area, about 42% of the surface area, about 43% of the surface area, about 44% of the surface area, about 45% of the surface area, about 46% of the surface area, about 47% of the surface area, about 48% of the surface area, about 49% of the surface area, about 50% of the surface area, about 51% of the surface area, about 52% of the surface area , about 53% of the surface area, about 54% of the surface area, about 55% of the surface area, about 56% of the water. surface area, about 57% of the surface area, about 58% of the surface area, about 59% of the surface area, about 60% of the surface area, about 61% of the surface area, about 62% of the surface area , about 63% of the surface area, about 64% of the surface area, about 65% of the surface area, about 66% of the surface area, about 67% of the surface area, about 68% of the surface area, about 69% of the surface area, about 70% of the surface area, about 71% of the surface area, about 72% of the surface area, about 73% of the surface area, about 74% of the surface area, about 75 % of the surface area, about 76% of the surface area, about 77% of the surface area, about 78% of the surface area, about 79% of the surface area, about 80% of the surface area, about 81% of the surface area, about 82% of the surface area, about 83% of the surface area, about 84% of the surface area, about 85% of the surface area, about 86% of the surface area, about 87% of the surface area, about 88% of the surface area, about 89% of the surface area, about 90% of the surface area, about 91% of the surface area, about 92% of the surface area, about 93% of the surface area, about 94% of the surface area, about 95% of the surface area, about 96% of the surface area, about 97% of the surface area, about 98% of the surface area, about 99% of the surface area, or about 100% of the surface area of a garment. Cosmetic Applications
[0161] In some aspects, the present invention relates to a cosmetic composition comprising comprising a composite powder, foam, liquid, oil, wax, base or emulsifying agent comprising a far infrared emitting bioceramic. The cosmetic compositions of the invention can comprise an effective amount of a bioceramic in various cosmetic vehicles, such as a cosmetic lotion, cream, eyelash mask, mascara, gel plaster and general makeup. A cosmetic composition of the disclosure can include various bioceramic to cosmetic vehicle ratios. For example, a disclosure composition can be 1 part bioceramic to 1 part cosmetic vehicle, 1 part bioceramic to 2 parts cosmetic vehicle, 1 part bioceramic to 3 parts cosmetic vehicle, 1 part bioceramic to 3 parts cosmetic cosmetic vehicle, 1 part bioceramic to 4 parts cosmetic vehicle, 1 part bioceramic to 5 parts cosmetic vehicle, 1 part bioceramic to 6 parts cosmetic vehicle, 1 part bioceramic to 7 parts cosmetic vehicle, 1 part cosmetic vehicle bioceramic for 8 parts cosmetic vehicle, 1 part bioceramic for 9 parts cosmetic vehicle, 1 part bioceramic for 10 parts cosmetic vehicle, 1 part bioceramic for 11 parts cosmetic vehicle, 1 part bioceramic for 12 parts vehicle cosmetic, 1 part bioceramic to 13 parts cosmetic vehicle, 1 part bioceramic to 14 parts cosmetic vehicle, 1 part bioceramic to 15 parts cosmetic vehicle, 1 part bioceramic to 16 parts cosmetic vehicle, 1 part bioceramic to 17 parts cosmetic vehicle, 1 part bioceramic to 18 parts cosmetic vehicle, 1 part bioceramic to 19 parts cosmetic vehicle, 1 part bioceramic to 20 parts of cosmetic vehicle, 1 part bioceramic to 21 parts cosmetic vehicle, 1 part bioceramic to 22 parts cosmetic vehicle, 1 part bioceramic to 23 parts cosmetic vehicle, 1 part bioceramic to 24 parts cosmetic vehicle, 1 part of bioceramic for 25 parts of cosmetic vehicle, 1 part of bioceramic for 26 parts of cosmetic vehicle, 1 part of bioceramic for 27 parts of cosmetic vehicle, 1 part of bioceramic for 28 parts of cosmetic vehicle, 1 part of bioceramic for 29 parts of cosmetic vehicle, 1 part bioceramic to 30 parts cosmetic vehicle, or any suitable ratio. In some cases, a developing bioceramic composition can be applied directly to the skin.
[0162] Another aspect of the subject described here are cosmetic compositions and, more particularly, cosmetic compositions to reduce facial expression marks, scars, skin blemishes, as well as to reduce / control puffiness in the eyes. An effective cosmetic composition for reducing facial expression marks, scars, redness of skin blemishes, as well as the reduction/control of eye puffiness, can be prepared by adding a bioceramic to a cosmetic composition, such as a lotion, cream, mascara, mascara, gel plaster, oil, foundation, wax, emulsifying agents or makeup powders in general, in various colors. Cosmetic compositions provide a beneficial biomodulating effect by providing far infrared energy that reduces facial expression marks on the skin, reduces puffiness in the eyes and reduces blemishes, making skin marks less obvious.
[0163] A developing composition can be applied to various skin types. Skin types include normal, oily, dry, sensitive and mixed types. Some people also have a combination of skin types on different areas of their skin. A developing composition can be applied to skin types that vary in terms of a) water content, which affects the comfort and elasticity of the skin; b) oil content (lipid), which can affect the smoothness of the skin; and c) level of sensitivity. A cosmetic revealing composition can provide beneficial far infrared radiation for various types of skins. For example, when exposed to drying factors, the skin may crack, peel or become itchy, irritated or inflamed. A reveal cosmetic makeup can help relieve itchiness, irritation, pain or inflammation.
[0164] A developing composition can be applied directly or indirectly to the skin. For example, a far infrared emitting bioceramic can be formulated inside an eye mask, and the eye mask can be worn by an individual to reduce eye puffiness. A far infrared emitting bioceramic can be administered topically and can be formulated into a variety of topically administrable compositions such as solutions, suspensions, lotions, gels, pastes, medicated sticks, balms, creams and ointments. Such pharmaceutical compositions may contain solubilizers, stabilizers, tonicity enhancing agents, buffers and preservatives.
[0165] A far infrared emitting bioceramic can be formulated as an oil or emulsion. Suitable lipophilic solvents or vehicles that can be formulated with a bioceramic described in the present invention include fatty oils such as sesame oil or synthetic fatty acid esters such as ethyl oleate or triglycerides, or liposomes. Aqueous suspensions may contain substances which increase the viscosity of the suspension, such as sodium carboxymethylcellulose, sorbitol or dextran. The suspension may also contain suitable stabilizers or agents, which increase the solubility of the compounds to allow for the preparation of highly concentrated solutions. Alternatively, the active ceramic ingredient may be in powder form for constitution with a suitable vehicle, e.g., sterile pyrogen-free water, before use.
[0166] In some cases, transdermal patches can provide the controlled release of far infrared energy to an individual. For example, the rate of absorption of far infrared radiation can be decreased by using rate-controlling membranes or by entrapping the compound in a polymeric matrix or gel. On the other hand, absorption enhancers can be used to increase absorption or far infrared energy. An absorption enhancer or vehicle can include absorbable pharmaceutically acceptable solvents to aid passage through the skin. For example, transdermal devices may be in the form of a bandage comprising a support member, a reservoir containing compounds and vehicles, a rate controlling barrier to deliver the compound to the subject's skin at a controlled and predetermined rate over a period of time. extended time and adhesives to fix the device to the skin.
[0167] Generally, a coloring agent and/or a resin can be used together with a bioceramic composition in a cosmetic application. A variety of coloring agents and resins can be used to form and color cosmetics, including organic and inorganic dyes or pigments. Polymeric materials approved by the Food and Drug Administration as "Indirect Food Additives" can be used as resins for use in cosmetic compositions comprising bioceramics. Non-limiting examples of polymeric materials that can be used as resins for cosmetic compositions include acrylics and modified acrylic plastics; acrylonitrile/butadiene/styrene copolymers; acrylonitrile/butadiene/styrene/methyl methacrylate copolymers; acrylonitrile/styrene copolymers; acrylonitrile/styrene copolymers modified with butadiene/styrene elastomer; cellophane; copolymers of cyclohexylenedimethylene terephthalate and 1,4-cyclohexylenedimethylene isophthalate; ethylene-acrylic acid copolymers; ethylene-1,4-cyclohexylenedimethylene terephthalate copolymers; ethylene-acrylic acid copolymers; ethylene-1,4-cyclohexylenedimethylene terephthalate copolymers; ethylene-ethyl acrylate copolymers; ionomeric resins; ethylene-methyl acrylate copolymer resins; ethylene-vinyl acetate copolymers; ethylene-vinyl acetate-vinyl alcohol copolymers; fluorocarbon resins; water-insoluble hydroxyethylcellulose film; isobutylene polymers; isobutylenebutene copolymers; 4,4'-isopropylidenediphenolepichlorohydrin resins; melamine-formaldehyde resins; nitrile rubber modified with acrylonitrile-methyl acrylate copolymers; nylon resins; olefin polymers; perfluorocarbon resins; polyarylate resins; polyarylsulfone resins; poly-1-butene resins and butene/ethylene copolymers; polycarbonate resins; polyester elastomers; polyetherimide resins; polyethylene resins, modified carboxyl; polyethylene, chlorinated; polyethylene, fluorinated; polyethylene, oxidized; polyethylene phthalate polymers; poly(p-methylstyrene) and poly(p-methylstyrene) modified rubber; polystyrene and polystyrene modified rubber; polysulfide-polyepoxy polymer resins; polysulfone resins; (poly)tetramethylene terephthalate; polyvinyl alcohol films; polyurethane resins; polymers in padded material styrene padded material; styrene-maleic anhydride copolymers; styrene-methyl methacrylate copolymers; textrils; urea formaldehyde resins; vinyl-ethylene chloride copolymers; vinyl-1-hexene chloride copolymers; vinyl chloride-lauryl vinyl ether copolymers; vinyl-propylene chloride copolymers; vinylidene chloride/methyl acrylate copolymers; vinylidene chloride/methyl acrylate/methyl methacrylate polymers; ethylene polymers, chlorosulfonated; 4,4'-isopropylidenediphenolepichlorohydrin thermosetting epoxy resins; mineral reinforced nylon resins; perfluorocarbon-cured elastomers; phenolic resins; cross-linked polyester resins; chlorinated polyester resins; polyethersulfone resins; polyamide-imide resins; poly(2,6-dimethyl-1,4-phenylene oxide resins); polyoxymethylene copolymers; polyoxymethylene homopolymers; polyphenylenesulfide resins; polyvinylidene fluoride resins; and cross-linked styrene-divinylbenzene resins.
[0168] Methods for preparing cosmetic compositions comprising the far infrared radiation emitting bioceramics described in the present invention include formulating the compounds with one or more inert pharmaceutically acceptable excipients or carriers to form a solid, semi-solid, foam composition, wax, cream, lotion or liquid. Such compositions may also contain small amounts of non-toxic adjuvant substances such as emulsifying or wetting agents, pH buffering agents, auxiliaries and other pharmaceutically acceptable additives. Standards
[0169] A bioceramic can be added to an article of garment in various regular or irregular patterns. A bioceramic pattern can cover the entire surface of a garment or a pattern can cover a portion of a garment. A bioceramic pattern covering an article of clothing may have regions of discontinuity, having a variety of shapes and sizes. For example, a pattern can be a honeycomb pattern (for example, with hexagonal discontinuity regions), a grid pattern (for example, with square or rectangular discontinuity regions), a random pattern (for example, with regions of discontinuity of discontinuity distributed randomly) and the like. In general, regions of discontinuity can be distributed across the surface at intervals that are regularly spaced or not regularly spaced. Regions of discontinuity can be formed with a variety of regular or irregular shapes, such as, for example, circular, half-circle, diamond, hexagonal, multilobal, octagonal, oval, pentagonal, rectangular, diamond-shaped shapes. square, star-shaped, trapezoidal, triangular, wedge-shaped and the like. If desired, one or more regions of discontinuity can be shaped like logos, letters or numbers. In some embodiments, the discontinuity regions can have sizes of about 0.1 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7mm, about 8mm, about 9mm, about 10mm or other desired distance. In some embodiments, regions of discontinuity can range from 0.1 mm to about 1 mm, from 1 mm to about 5 mm, from 1 mm to about 10 mm, from 1 mm to about 15 mm, from 1 mm. mm to about 20 mm, 1 mm to about 25 mm, 1 mm to about 30 mm, or other desired distance. In general, regions of discontinuity can have the same or different shapes or sizes.
[0170] A bioceramic pattern can be applied as a coating covering an inner and/or outer surface of an article of clothing. A bioceramic pattern can permeate a material such as tissue. A bioceramic pattern can cover various parts of a tissue in a continuous, discontinuous, regular or irregular pattern, or in any combination thereof. A bioceramic standard can permeate less than 1%, less than 5%, less than 10%, less than 15%, less than 20%, less than 25%, less than 30%, less than 35%, less than 40% , less than 45%, less than 50%, less than 55%, less than 60%, less than 65%, less than 70%, less than 75%, less than 80%, less than 85%, less than 90% , less than 95% or less than 99% of an inner surface of an article of clothing, an outer surface of an article of clothing, or any combination thereof.
[0171] The following non-limiting examples further illustrate the present invention. EXAMPLESEXAMPLE 1: Preparation of a powdered bioceramic composition
[0172] Kaolinite is extracted on the outskirts of the city of Parintins, in the state of Amazonas, Brazil. The city is located in the Lower Amazon region (coordinates: latitude: 2° 37' 42“ South/longitude: 56° 44' 11“ west of Greenwich, 50 m above sea level). Alternatively, kaolinite is obtained by purchasing from a mining company/supplier.
[0173] The extracted kaolinite is washed with hydrogen peroxide (H2O2) and allowed to dry. The dried kaolinite is then finely ground and mixed with tourmaline; aluminum oxide (Al2O3); silicon dioxide (SiO2); and zirconium oxide (ZrO2) until a homogeneous mixture is obtained. The resulting bioceramic composition contains 50% by weight of kaolinite, 10% by weight of tourmaline, 18% by weight of aluminum oxide, 14% by weight of silicon dioxide and 8% by weight of zirconium oxide.
[0174] A bioceramic composition was also synthesized. The resulting bioceramic contains any composition described in the present invention, including about 50% kaolinite, about 10% tourmaline, about 18% aluminum oxide, about 14% silicon dioxide and about 8% oxide of zirconium.EXAMPLE 2: Application on clothing
[0175] A developing bioceramic is a refractory, inorganic, polycrystalline composition that can be reduced to a powder form by grinding, crushing or other suitable method. In powder form, a bioceramic is incorporated into a variety of materials; including various types of polymers and inks. A bioceramic powder is incorporated into a fabric substrate to apply a paint comprising the bioceramic to the fabric.
[0176] A fabric substrate which includes 88 by weight of polyamide and 12% by weight of elastane was obtained. A bioceramic composition prepared according to the method of example 1 was incorporated into a plastisol paint in an amount of 10 to 50% by weight and mixed. The mixture was applied to the fabric substrate using a traditional screen printing process. The specific ink type was selected based on the chosen fabric.EXAMPLE 3: Silkscreen application of bioceramics to the garment (eg a shirt)
[0177] Concentration: Ceramic materials are mixed with the paint at a concentration of 30% of the total weight/volume.
[0178] Mixing process: ceramics were added to the paint gradually. The regular mixing process was applied using a mixer that is usually used to mix pigments and paints. The materials are mixed until a consistent and uniform mix/slurry is achieved. The process was quick as the ceramic mixes well with all different types of paints.
[0179] Slurry/Blend Durability: A well-sealed mixture is stored and used up to one week after production.
[0180] Application: The bioceramic material was applied in the same way as regular ink through a screen printing process. It was observed that, due to their particle size, ceramic materials can scratch the screens. It is recommended that, after every 1000 shirts, the screens are checked/inspected and, if necessary, they are replaced, especially to avoid defects in the application and appearance of the logo.
[0181] Tissue Selection: Ceramics did not cause noticeable tissue damage. It has been observed that fabrics that are too porous or cannot go through the common drying process commonly used in screen printing.
[0182] Ink Selection: Ceramics can increase ink density and the ink type should be selected by a person skilled in the art based on the type of fabric used.
[0183] Drying process after screen printing: Due to the fact that ceramics may contain a small amount of moisture, it has been observed that drying may take longer than usual. The duration and intensity of the process depends on the type of fabric and ink selected. After the first experimental analysis with the selected fabric and ink, the product should be sent for a wash test to make sure the ink has not come off or cracked.
[0184] A screen printing process is used to provide a ceramic for an article of clothing with a desired pattern. A screen printing approach is used to intersperse a print with a pattern on a shirt. FIGURE 1 illustrates a liner comprising a ceramic composition of the disclosure that was fabricated with a screen printing application. EXAMPLE 4: Application point-of-application approach of bioceramics to the garment (eg a shirt)
[0185] Concentration: Ceramic materials are mixed with silicone or a polymer such as an m-gel in the ratio of 1 part ceramic to 9 parts silicone. Alternatively, ceramic materials are blended with a polymer such as an m-gel in the ratio of 1 part ceramic to 9 parts m-gel.
[0186] Application: A device was used to apply the ceramic stitches to the fabric in a desired pattern. A stitch application approach is used, for example, to interleave a pattern into a shirt. FIGURE 1 illustrates a jacket comprising a ceramic composition of the disclosure.
[0187] Tissue Selection: Ceramics do not cause noticeable tissue damage. A stitch application approach is used to apply a bioceramic to specific areas of fabric or garment. In some cases, a spot application approach is used to apply the ceramic to specific areas of the part, even on top of screen printing, to achieve a higher ceramic concentration per surface area. A stitch application approach is used around the shoulders, elbows or any area where it is desirable to apply a higher concentration of ceramic.EXAMPLE 5: Bioceramics application bonding/solution approach to the garment (eg, a shirt). )
[0188] Concentration: As an alternative to mixing a ceramic with an ink and using a screen printing or dot approach to apply the ceramic to a fabric, a binder solution approach is used. A binder solution comprises up to 50% ceramic and up to 50% binder solution or slurry.
[0189] Application: A fabric is placed in a slurry solution comprising a ceramic and a binder in a desired concentration. The tissue is removed from the slurry solution and allowed to dry. The fabric is then impregnated or infused with a developing ceramic. The fabric that is impregnated or infused with the ceramic is placed directly in contact with an individual's skin.EXAMPLE 6: Visible repeat pattern approach of applying bioceramics to the garment (eg, a shirt)
[0190] Concentration: A first solution comprising a paint is prepared. A second solution, slurry or binder comprising from about 10% ceramic to about 50% ceramic is prepared by mixing a developing ceramic with the ink, slurry or binder.
[0191] Application: A first pattern is sprayed, printed, screen-printed or otherwise applied to a fabric. The first pattern consists of paint and does not contain a bioceramic material. A second pattern, comprising from about 10% ceramic to about 50% ceramic, is subsequently sprayed, screen-printed, or otherwise applied to the surface of the first pattern. Optionally, a silicone coating is applied over the second pattern to provide a glossy appearance of the pattern applied to the fabric. Optionally, a silicone coating is mixed with a concentration of ceramic before being applied as a coating. EXAMPLE 7: Fabrication of a dressing
[0192] A thermoplastic elastomer (TPE) is liquefied with a developing bioceramic. TPE and ceramic are mixed at a concentration of about 1 part ceramic to 1 part TPE, 1 part ceramic to 2 parts TPE, 1 part ceramic to 3 parts TPE, 1 part ceramic to 4 parts of TPE, 1 part ceramic to 5 parts TPE, 1 part ceramic to 6 parts TPE, 1 part ceramic to 7 parts TPE, 1 part ceramic to 8 parts TPE, or 1 part ceramic to 9 parts TPE of TPE. The liquefied mixture is placed in a mold. The blend of TPE and bioceramic is allowed to solidify to provide a mold-shaped garment. The garment is removed from the mold. The garment is a quilted material quilted material thermoplastic quilted material comprising a bioceramic, such as the quilted material quilted material quilted material illustrated in FIGURE 3.EXAMPLE 8: Bioceramics as anti-inflammatory agents and cytokine modulation
[0193] Injections are applied to laboratory mice of the bioceramic composition of example 1. On the 5th day after CFA injection (after 5 consecutive bioceramic treatments), the mouse's right hind paw is collected and used to estimate levels of cytokine by enzyme-linked immunosorbent assay (ELISA) with sample values corrected for protein levels. Optionally, the following cytokines are evaluated, individually or in groups: TNF-α, IL-1β, IL-10 and IL-6. The absorbance for the aforementioned cytokines could be measured using a microplate reader at 450 and 550 nm. The cytokine levels of mice could be determined to confirm the anti-inflammatory effect of the bioceramic compositions.EXAMPLE 9: Determination of oxidative stress and antioxidative enzyme levels
[0194] Injections are applied to laboratory mice of the bioceramic composition of example 1.
[0195] On the 5th day after CFA injection, the tissues of the right hind paw (skin and muscles) of mice can be collected and used to assess oxidative damage. For this test, the formation of thiobarbituric acid reactive species (TBARS) is measured during an acidic reaction under heating. The samples are mixed with 1 ml of 10% trichloroacetic acid (TCA) and 1 ml of 0.67% thiobarbituric acid and then they are heated in a boiling water bath for 15 min. TBARS levels are determined by absorbance at 535 nm. Results are expressed as malondialdehyde equivalents (MDA) (nmol/mg protein).
[0196] Oxidative damage to proteins is measured by the quantification of carbonyl groups, based on the reaction with dinitrophenylhydrazine (DNPH), as described above. Proteins are precipitated by the addition of 20% trichloroacetic acid and are optionally redissolved in DNPH; absorbance is read at 370 nm. Results can be reported as nmol carbonyl content per mg protein (nmol/mg protein) or results can be reported using another suitable unit.
[0197] To determine catalase activity (CAT), paw tissues are subjected to ultrasound in 50 mmoL/L phosphate buffer (pH 7.0), and the resulting suspension is centrifuged at 3000 x g for 10 minutes. The supernatant is used for the enzyme assay. CAT activity is measured by the rate of decrease in the absorbance of hydrogen peroxide at 240 nm. Results can be reported as (U/mg protein) or any other suitable unit.
[0198] Superoxide demutase (SOD) activity is analyzed by measuring the inhibition of adrenaline auto-oxidation as described above. All biochemical measurements are normalized for protein content, with bovine albumin being the standard. All results are normalized to the protein concentration measured by the Lowry assay. Results are reported as (U/mg protein) or any other suitable unit.EXAMPLE 10: Effect of far infrared emitted by bioceramics on physical performance parameters in mice
[0199] Objective: To assess the effect of far infrared radiation therapy emitted by bioceramics on physical performance parameters in mice undergoing a swimming protocol.
[0200] Methods: Experiments were performed with male Swiss mice (30 to 35 g) after approval by the Ethics Committee of the University of Southern Santa Catarina. The mice were randomly divided into 2 groups and submitted to a 30-min swimming protocol on day 21. For the treatment, a padded material made of bioceramic padding material containing the composition described in example 1 (BioCorn PVC 80% - bioceramic materials 20 %) was placed inside the animal box for three weeks. The control animals were placed in a quilted material with fake quilting material (100% BioCorn PVC without bioceramics) and were submitted to the same experimental protocol. At the end of each week, body weight and food and water intake were measured, and an exhaustion test was performed in which mice were allowed to swim to exhaustion with a 5% body weight load strapped to their tail. The point of exhaustion was determined when the animal could not keep its head above the water surface for more than 5 seconds. At the end of the third week, the grip strength of the right hind limb was measured using a strain measurement force feedback system and the weight of the gastrocnemius muscle was assessed with an analytical balance.
[0201] Results: Far infrared radiation emitted by a quilted material quilted bioceramic material containing the composition of example 1 increased the time needed to reach exhaustion in the forced swim test (133.1%, 60.4% and 90, 83% in weeks 1 to 3) but did not affect body weight or water or food consumption. Although the weight of the gastrocnemius muscle was not affected, the bioceramics of example 1 increased the grip strength of the hind limb by 6.6%.
[0202] Conclusion: The therapy with far infrared radiation emitted by a bioceramic of example 1 increased the grip strength of the hind limb and the time to reach exhaustion in the mouse submitted to a swimming protocol of three weeks. These results indicate increased endurance, muscular endurance and general vigor (energy levels). EXAMPLE 11: Therapy with far infrared radiation emitted by bioceramics improves postural sway in human athletes
[0203] Objective: The aim of the present study was to evaluate the effect of far infrared radiation therapy emitted by bioceramics on the orthostatic balance of judo practitioners (judokas) of a team from a Brazilian university in a double-blind controlled trial.
[0204] Methods: A total of 17 athletes (7 women and 10 men; 23 ± 4.75 age) from the University of Southern Santa Catarina (UNISUL) wore a bioceramic shirt containing the composition of the shirt from example 1 (shirt with screen-printed bioceramics) or a fake shirt (without bioceramics) during practice (for two hours, five times a week for a period of five months). The judokas were from seven different weight categories and were evenly divided into two experimental groups (bioceramic jackets or not) in such a way that each group had approximately the same number of athletes from each weight category. The center of pressure (CoP) parameters (length, area of sway, velocity in the anteroposterior and mediolateral directions) were measured in three static bipedal posture tasks lasting 30 s - athletes were asked to keep their eyes open and stay in a narrow position on an equilibrium platform (T-plate equilibrium platform, Medicapteurs, France). The evaluations were carried out before and after 5 months of using the bioceramic jackets.
[0205] Results: The results obtained showed statistically significant decreases (p < 0.05) in all CoP parameters evaluated (length, oscillation area, velocity in the anteroposterior and mediolateral direction) in the athletes of the bioceramic jacket group compared with the shirt group without bioceramics.
[0206] Conclusion: Therapy with far infrared radiation emitted by a bioceramic shirt containing the composition of example 1 positively affected the orthostatic balance of judo practitioners on a team from a Brazilian university.EXAMPLE 12: Far infrared radiation emitted by bioceramics reduces mechanical and thermal hyperalgesia in an animal model of chronic inflammatory pain
[0207] Objective: This study evaluated the effect of far infrared radiation emitted by the bioceramic composition of example 1 incorporated in a quilted material quilted material against mechanical and thermal hyperalgesia, as well as the increase in paw temperature and edema formation in a mouse model of inflammatory pain.
[0208] Methods: Experiments were performed with male Swiss mice (30 to 35 g) after approval by the Ethics Committee of the University of Southern Santa Catarina. The animals received an intraplantar injection of Freud's complete adjuvant (CFA, 20 μl - 70%) and, for treatment, the quilted material quilted bioceramic material (80% BioCorn PVC - 20% bioceramic materials) was placed inside of the animal box. After 24 h of exposure to the product, mechanical and thermal hyperalgesia were assessed as the frequency response of 10 presentations of a 0.4 g von frey filament or by heat stimuli applied to the animals' right hind paw (plate method of heating). Assessments were performed daily for 10 days. After evaluation, animals were placed in their boxes and re-exposed to the padded material padded material until subsequent evaluation (24 hours later). In addition, edema formation and hindpaw temperature were evaluated on experimental days 1, 3 and 10 with a micrometer and a digital thermometer, respectively. The control animals were placed in a quilted material with fake quilting material (100% BioCorn PVC without bioceramics) and were submitted to the same experimental protocol.
[0209] Results: Acute exposure to padded material quilted bioceramic material induced analgesia, which lasted 2 hours (P < 0.001 - maximum inhibition 53 ± 11%). Chronic treatment reduced mechanical hyperalgesia on all assessment days and thermal hyperalgesia on days 1 and 3. In addition, treatment decreased paw temperature on days 1 and 3, 8 ± 1% (P < 0.001) and 5 ± 1% (P < 0.05) but did not affect edema formation.
[0210] Conclusion: Far infrared radiation emitted by the padded material quilted bioceramic material reduced mechanical and thermal hyperalgesia of inflammatory origin, as well as the increase in paw temperature induced by intraplantar injection of CFA in mice.EXAMPLE 13: A double trial blind placebo-controlled trial randomized with a University Division 1 football team to assess physical fitness parameters.
[0211] Objective: To evaluate the effect of practice uniforms printed with bioceramics on: respiratory capacity, back and leg muscle strength and cardiorespiratory fitness.
[0212] Design: A randomized, double-blind, placebo-controlled trial involving 30 healthy soccer players. Each participant was randomized by manual draw to wear an exercise suit comprising a bioceramic composition from Example 1 or exercise suits without bioceramics during regular practice sessions, as well as a bioceramic or negative control band throughout the day. Assessments were performed with both groups once a week for 4 weeks on predetermined days before the start of practice days.
[0213] Methodology and test results(a) Respiratory capacity Respiratory capacity was assessed with a spirometer (model SP-10). The parameters evaluated were forced vital capacity (FVC), forced expired volume in one second (FEV1) and maximum expiratory flow (PEF). Forced vital capacity (FVC) is the volume of air that can be forcefully blown after complete inspiration, measured in liters. FVC is the most basic maneuver in spirometry testing.FEV1 is the volume of air that can be forcefully blown out in one second after complete inspiration.Maximum expiratory flow (PEF) is the maximum flow (or velocity) achieved during the maximum forced expiration starting at full inspiration, measured in liters per minute.(b) Back and leg muscle strengthA back/leg dynamometer (Baseline, USA) was used to measure leg and back muscle strength. Using a prone grip, the participant grasped the device's cable bar and slowly stretched their legs to their maximum level.(c) Cardiorespiratory fitness Cardiorespiratory fitness was assessed using the standardized 3-minute exercise test (predetermined along with the team coach). The cardiorespiratory endurance index is derived from the post-test heart rate recovery with the following formula: cardiorespiratory endurance index = exercise duration (seconds) x 100/sum of heart beats during the recovery period/2. The sum of the heart beats during the recovery period is the sum of the heart rates for 3 periods after the test: 1 to 1.5 minutes, 2 to 2.5 minutes and 3 to 3.5 minutes.
[0214] Conclusion: The results indicate that, in all the different parameters analyzed, athletes using bioceramics technology had better overall results compared to athletes who were using placebo equipment.EXAMPLE 14: Effect of far infrared radiation emitted by bioceramics on clinical measurements of physical fitness
[0215] Objective: To assess the effect of far infrared radiation therapy emitted by bioceramics on flexibility, grip strength and breathing capacity, a double-blind randomized placebo-controlled trial involving 9 to 12 basketball players from Florida Atlantic University (ages 18 to 22).
[0216] Methods: Each participant was randomized to wear a bioceramic shirt (screen-printed bioceramic shirt) containing the bioceramic of example 1 or a negative control shirt (no bioceramic). Baseline assessments were performed at week 1. Players wore the jerseys three times a week during practice hours - 9:00 am to 12:00 pm. Assessments were performed with both groups once a week for 3 weeks on Wednesdays, during the first hour of the day's practice. In the second round of testing, the groups were switched. The group that was wearing the BioPower workout uniforms without bioceramics were chosen to wear the BioPower shirts 7 days a week (all day) and the group that was previously wearing the BioPower suits stopped using the technology and served as a control. Assessments were performed with both groups once a week for 3 weeks on Wednesdays, during the first hour of the day's practice.
[0217] Flexibility was measured with the sit and reach test (Sit Box and Reach Novel Flex-Tester®). For evaluation, each individual was asked to sit on the floor with their knees against the floor, and the flat box was placed against the plantar surface of their feet. Then the subject stretched towards the box and moved as far away from the index as possible. The mean of three measurements was used in the analysis.
[0218] The grip strength of the dominant hand was measured with a hand dynamometer, a Smedley Digital Spring Baseline Hand dynamometer, with subjects standing with their elbows extended. The mean score of the three trials was recorded for analysis.
[0219] Respiratory capacity was assessed with a spirometer (model SP-10). The parameters evaluated were forced vital capacity (FVC), forced expired volume in one second (FEV1) and maximum expiratory flow (PEF). The best of the three measurements was used in the analysis. Forced vital capacity (FVC) is the volume of air that can be forcefully blown after complete inspiration, measured in liters. Forced exhaled volume in one second (FEV1) is the volume of air that can be forcefully blown out in one second after complete inspiration. Maximum expiratory flow (PEF) is the maximum flow (or velocity) achieved during forced maximum expiration starting at full inspiration, measured in liters per minute.
[0220] Results: Flexibility.
[0221] Figure 3 is a graph that illustrates a non-limiting example of the effects of the bioceramics of the present disclosure on flexibility. In the first round of testing, the use of a bioceramic did not affect flexibility compared to baseline levels (FIGURE 3, Table A). In the second round of testing, compared to baseline levels, the use of bioceramics technology increased flexibility by 5.5% and 14.1% in the first and second week of continuous use, respectively. Flexibility was not affected in the group of athletes not using the technology (FIGURE 3, Table B). Grip strength. In the first round of testing, the use of bioceramics increased grip strength by 5.6% in the second week of continuous use compared to baseline levels. The grip strength of the control group was not changed from one assessment to the other (FIGURE 3, Table C). In the second round of testing, compared to baseline levels, the use of bioceramic technology increased grip strength by 10.8% and 10.9% in the first and second week of continuous use, respectively (FIGURE 3, Table D). On the other hand, in the group consisting of athletes who were using the technology for 2 weeks (in the first round of testing) and discontinued its use, there was a decrease in grip strength of 7.23% and 13.51% in the first and second week of evaluations, respectively (FIGURE 3, Table D).
[0222] Respiratory capacity. Figures 4 and 5 are graphs illustrating a non-limiting example of the effects of the bioceramics of the present disclosure on respiratory capacity. FIGURE 4 illustrates an example of the effect of a bioceramic of the present disclosure on forced vital capacity (FVC) and forced expired volume in 1 second (FEV1). FIGURE 4 illustrates a non-limiting example of the effect of a bioceramic of the present disclosure on maximum expiratory flow (PEF). In the first round of tests, the use of bioceramics increased FVC (5.8% - FIGURE 4, Table A) and FEV1 (5.9% - FIGURE 3, Table C) but did not affect the PEF (FIGURE 5, Table A) ) compared to baseline levels. In the control group, FVC, FEV1 and PEF decreased from one assessment to the other (FIGURE 4, Tables A and C and FIGURE 5, Table A). In the second round of testing, compared to baseline levels, the use of bioceramics technology increased FVC (5.8% in the second week - FIGURE 4, Table B); FEV1 (15% and 10% at week one and two, respectively - FIGURE 4, Table D) as well as PEF (52.77% and 50.9% at week one and two, respectively - FIGURE 5, Table B). In the group that consisted of athletes who used the technology for 2 weeks (in the first round of tests) and who discontinued its use, FVC and FEV1 fluctuated from one assessment to the other (FIGURE 4, Tables B and D, respectively), while that the PEF, on the other hand, decreased by 19.7% in the first and 23.3% in the second week of evaluations (FIGURE 5, Table B).
[0223] Conclusion: Far infrared radiation therapy emitted by bioceramic shirts increased flexibility, grip strength, and breathing capacity in healthy Florida Atlantic University basketball players. Long-term continuous use induced the most significant results.EXAMPLE 15: Effect of Bioceramic Printed Garment on Muscle Endurance and Cardiorespiratory Fitness in Athletes
[0224] Objective: To evaluate the effect of a bioceramic printed exercise garment (shirts and shorts) on muscle endurance and cardiorespiratory fitness.
[0225] Test methodology and results: Each participant wore a bioceramic shirt/short during exercise (3 times a week - 120 minute training session). In addition, participants wore a bioceramic shirt for 6 to 8 hours a day, 7 days a week. Assessments were performed once a week, on Mondays. (d) Muscle strength
[0226] Muscle endurance was measured with the lifting test. Subjects were asked to (1) lie down on the floor with their hands slightly wider than shoulder-width apart and then (2) raise their bodies off the floor by extending their arms, with the body in a straight line. . The maximum number of flexions performed until exhaustion was used to represent muscle resistance.
[0227] FIGURE 6 illustrates the effect of bioceramics on muscle strength in humans. The data represented in FIGURE 6 demonstrate that there was a gradual increase in the maximum number of flexions performed by the athletes. A better increase compared to the evaluation performed without the use of bioceramics was obtained in week 4 (13.95%). FIGURE 6 illustrates the results of an experiment, where N = 5. The numbers above the bar indicate an increase compared to the “No BioPower” week control.(e) Cardiorespiratory fitness
[0228] Cardiorespiratory fitness was assessed using a standardized test with small variations. The cardiorespiratory endurance index is derived from the post-test heart rate recovery with the following formula: cardiorespiratory endurance index = exercise duration (seconds) x 100/sum of heart beats during the recovery period/2. The sum of heartbeats during the recovery period was the sum of the heart rates during 3 periods after the test: from 1 to 1.5 minutes, from 2 to 2.5 minutes and from 3 to 3.5 minutes.2 Two evaluations were performed: the first after a 10-minute warm-up session and the second after the lifting test described in item 3.2. The standardized 3-minute time was used in the calculations to normalize the results of both assays to facilitate comparisons. FIGURE 7 illustrates the effect of bioceramics on human cardiorespiratory fitness. FIGURE 7 illustrates the results of an experiment, where N = 5. In FIGURE 7, panel A illustrates the results of an assessment performed after the warm-up session. In FIGURE 7, panel B illustrates the results of an assessment performed after the survey session. The numbers above the bar indicate an increase compared to the “No BioPower” week control.
[0229] The results presented in FIGURE 7 indicate that the use of bioceramics increased the cardiorespiratory index in all assessments performed both after the warm-up (FIGURE 7, table A) and the lifting sessions (FIGURE 7, table B). The maximum increment compared to the evaluation performed without the use of bioceramics occurred in week 3 (6.10% and 7.69%).
[0230] Conclusion: The results indicate that the use of a bioceramic printed garment helped to increase muscle endurance and cardiorespiratory fitness in 5 MMA fighters.EXAMPLE 16: Effect of bioceramic paints on CFA-induced mechanical hypersensitivity
[0231] Purpose: The use of bioceramic paint containing the composition of Example 1 on CFA-induced mechanical hypersensitivity was evaluated.
[0232] Methods: Experiments were carried out using adult male Swiss mice weighing 25 to 35 g, housed at 22 °C, under a 12h light/12h dark cycle (lights on at 06:00), with access to food and water ad libitum. The experiments were carried out after approval of the protocol by the Ethics Committee of the University of Southern Santa Catarina (UNISUL). The animals (n = 8) underwent intraplantar (i.pl.) injection (right hind paw) of a solution containing 20 µL of Freud's complete adjuvant (CFA, 70%). For the treatment, a bioceramic paint (10% and 20% concentration) was applied to the bottom of the animal box. After 24 h of nociceptive mechanical exposure, the threshold was assessed as the response frequency of 10 presentations of a 0.4 g von frey filament applied to the animals' right hind paw. Assessments were also performed on days 2 and 3 after CFA injection.
[0233] Results: The results show that i.pl. of CFA induced mechanical hypernociception (P < 0.001) which was significantly reduced by exposure to bioceramic paint (20 but not 10% bioceramic concentration) applied to the underside of the animals' box. The effect lasted up to 4 hours (days 2 and 3). FIGURE 8 illustrates the effects of bioceramic paint on CFA-induced mechanical hypersensitivity. In the evaluation of 8 individuals, the vertical lines indicate the standard error of the means * p < 0.05. FIGURE 9 illustrates a bioceramic painting.
[0234] Conclusion: Bioceramic paint reduced mechanical hypersensitivity induced by foot injection of CFA.EXAMPLE 17: Far infrared radiation emitted by ceramic materials increases foot temperature and reduces mechanical hypersensitivity and knee edema in a model of monoiodoacetate-induced osteoarthritis mouse
[0235] Objective: This study investigated the effect of far infrared radiation emitted by ceramic materials on skin temperature, mechanical peta hypersensitivity and knee edema in a mouse model of monoiodoacetate-induced osteoarthritis (MIA).
[0236] Methods: Experiments were performed with male Winsar rats (200 to 250 g) anesthetized with a mixture of ketamine and xylazine (50 and 10 mg/kg, respectively, i.pl.). Joint damage was induced by a single intra-articular injection of MIA (1 mg/50 μL; Sigma UK - which interrupts glycolysis resulting in chondrocyte death) through the infrapatellar ligament of the right knee. Control animals received a single injection of saline solution (50 μL). Three distinct measurements were evaluated: (1) thermal analysis of the central areas of the animals' forelegs (with a portable infrared camera ThermaCAM® E320 - Flir, Sweden - with a resolution of 320x240 pixels, thermal sensitivity of < 0.10 °C at 25 °C and accuracy ± 2 °C - positioned 0.5 m away from the animals' paws. Infrared images were analyzed using FLIR QuickReport 1.2 software); (2) the limits of mechanical withdrawal of the hindpaw (using von Frey monofilaments - Semmes-Weinstein monofilaments of bending strengths from 1 to 15 g), which provide an index of central sensitization; and (3) edema formation (measured with a digital caliper - Pantec, Brazil), which is directly associated with the localized inflammatory response. For the treatment of a quilted bioceramic material, the bioceramic of example 1 (80% BioCorn PVC - 20% ceramic materials) was placed inside the animal box; control animals were placed in a negative control padded material (100% PVC BioCorn without ceramic) and were subjected to the same experimental protocol.
[0237] Results: On day 3 after acute exposure from MIA injection (2 hours) the bioceramic padding material increased paw temperature (± 4 °C), although only one chronic exposure to treatment (days 7 and 10 after MIA ) reduced mechanical hypersensitivity (p < 0.001) and knee edema (p < 0.001).
[0238] Conclusion: Far infrared emitted by ceramic materials increased paw temperature (after acute exposure), whereas only prolonged treatment reduced mechanical hypersensitivity and knee edema in a mouse model of MIA-induced osteoarthritis. EXAMPLE 18: Far infrared radiation emitted by bioceramics reduced hypernociception of inflammatory origin in mice
[0239] Objective: The aim of this study was to evaluate the effect of far infrared radiation emitted/reflected by bioceramics in a padded material containing the bioceramic of example 1, on pain of inflammatory origin, as well as the increase in temperature of the paw and the formation of edema in an experimental model of inflammation in mice.
[0240] Methods: Experiments were carried out using adult male Swiss mice weighing 25 to 35 g, housed at 22 °C, under a 12h light/12h dark cycle (lights on at 06:00), with access to food and water ad libitum. The experiments were carried out after approval of the protocol by the Ethics Committee of the University of Southern Santa Catarina (UNISUL). The animals (n = 8) underwent intraplantar injection (right hind paw) of a solution containing 20 μL of Freud's complete adjuvant (CFA, 70%). For the treatment, a padded bioceramic material was placed inside the animal box. After 24 h of exposure to the product, the mechanical nociceptor threshold was evaluated as the response frequency of 10 presentations of a 0.4 g von frey filament applied to the animals' right hind paw. Assessments were performed daily for 10 days - after each assessment, the animals were placed back in their boxes and re-exposed to the padded material, until further assessment (24 hours). In addition, the volume (eedema formation) and temperature of the hind paws were evaluated on experimental days 1, 3 and 10 with a plethysmometer and a digital thermometer, respectively. Control animals were placed in a fake padded material (consisting of 100% BioCorn PVC (without bioceramic) and were subjected to the same experimental protocol.
[0241] Results: The results show that i.pl. injection; of CFA induced mechanical hypernociception (P < 0.001) which was significantly reduced by exposure to the bioceramic quilting material containing the bioceramic of example 1. Analgesia lasted up to 2 hours with maximum effect 30 min after treatment (P < 0.001 - maximum inhibition of 53 ± 11%). Chronic treatment with padded bioceramic material reduced mechanical and hypernociception every day of evaluation. In addition, treatment significantly decreased paw temperature on days 1 and 3, 8 ± 1% (P < 0.001) and 5 ± 1% (P < 0.05) respectively, compared to the control group.
[0242] Conclusion: The padded bioceramic material reduced mechanical hypernociception of inflammatory origin, as well as the increase in paw temperature induced by intraplantar CFA injection in mice.EXAMPLE 19: Uses of bioceramics that emit far infrared radiation in the treatment of conditions human
[0243] A bioceramic that emits far infrared radiation is used to modulate or treat one or more of the following: pain, muscle endurance, vigor, muscle strength, cardiorespiratory fitness, respiratory capacity, flexibility, cell metabolism, analgesia, cell oxidation, fibromyalgia , inflammation, oxidative stress, blood circulation, intolerance to cold environments, arthritis or vascular disease, skin perfusion, arrhythmia, high blood pressure, tissue damage, an aesthetic effect such as a reduction in the individual's cellulite and improved quality of life.
[0244] Methods: A subject wears an article of clothing from the revelation, which comprises a bioceramic for at least 6 weeks. The following parameters, alone or in combination, are used to measure the effects of articles of clothing impregnated with (a) ceramic material/materials that emit infrared radiation in the treatment of human subjects with a condition disclosed in the present invention: a) quality life, sleep patterns, depression and anxiety; b) pain, muscle strength and flexibility; c) balance and distribution of foot pressure; d) stress (measured by the activity of the autonomic, sympathetic and parasympathetic nervous systems; e) temperature of the body surface; f) inflammatory mediators (anti and pro-inflammatory cytokines); or g) oxidative stress and antioxidant systems.
[0245] Bioceramic treatments: T-shirts or padded materials impregnated with a BioPower® brand infrared emitting bioceramic material are distributed among the groups. Patients are instructed to wear the article of clothing comprising the ceramic materials during the day, at night, or during sleep. The treatment is carried out for about three consecutive months. FIGURE 10 illustrates a human wearing exemplary t-shirts or quilted materials comprising a revelation pottery.
[0246] Parameters: some of the following parameters, alone or in combination, are used to quantify an effectiveness of a bioceramic material in an individual: a) grip strength assessment; b) flexibility assessment; c) thermography; d) evaluation of pro-inflammatory and anti-inflammatory cytokines; e) assessment of antioxidants, assessment of oxidative stress markers, or f) questionnaires.
[0247] Grip strength assessment: A dynamometer is used as an instrument for grip strength assessment. The working principle of the dynamometer is based on the deformation suffered by a spring due to the action of a force. The strength of strength is graded, so the dynamometer is a useful method for measuring the strength of some individuals. The dynamometer is particularly useful for measuring strength intensity, for example, in humans afflicted with fibromyalgia, as dynamometer measurements take into account common and predominant muscle fatigue in the upper limbs (UL) and appendicular skeleton in comparison with the axial upper limb studies.
[0248] Flexibility assessment: Flexibility assessment is measured with the third toe-ground test. The instrument measures an individual's overall flexibility in relation to the individual's posture flexibility, an individual's ability to keep their feet together, and an individual's maximum trunk flexibility without bending the knees. This measurement is taken on individuals with relaxed heads and the distance between the floor and the third toe is measured with a measuring tape, on the right or left side. An individual who is able to touch the ground is considered an individual with good flexibility.
[0249] Thermography Evaluation: Thermography is a useful technique in the analysis of hyper-radiation points in infrared imaging, as it allows the detection of Thermography images on the surface skin of an individual, such as the skin of the human body. The technique is optionally performed on a human who is standing and undressed, with arms extended at the sides of the body, but not touching the body. The temperature is maintained at about 20°C throughout the procedure. Before capturing the image, subjects are asked to rest for 15 minutes to allow their body temperature to acclimate to room temperature.
[0250] Evaluation of pro-inflammatory and anti-inflammatory cytokines: Blood samples are collected and prepared for analysis by centrifugation (IL-10, IL-6, IL-1 β and TNF-α). Serum is processed for cytokine analysis. The serum can optionally be kept frozen at 80 °C for up to one year. Serum is analyzed by immunoassay (pg/dL) (sandwich ELISA), using commercial kits, and cytokine concentration is determined. One of skill in the art will appreciate that other methods known in the art can optionally be used to assess levels of pro-inflammatory and anti-inflammatory cytokines.
[0251] Evaluation of antioxidants and determination of oxidative stress: a) thiobarbituric acid-reactive substances - TBARS: to determine the effects of bioceramics in the modulation of oxidative stress, a sample comprising serum lipids is collected from an individual. The sample is analyzed by heating it in an acidic reaction by TBARS. (Esterbauer, H., Cheeseman, K.H. Determination of aldehydic lipid peroxidation products: malonaldehyde and 4-hydroxynonenal. Methods Enzymol, v. 186, p. 407-421, 1990). Briefly, the serum is mixed with 1 ml of 10% trichloroacetic acid and 1 ml of 0.67% thiobarbituric acid and subsequently placed in a boiling water bath for 15 min. Absorbance at 535 nm is measured using 1,1,3,3-tetramethoxypropane as the external standard. Results are calculated and reported as malondialdehyde equivalents per milligram of protein. A person skilled in the art will note that other methods known in the art can optionally be used to assess levels of oxidative stress in a sample.b) protein carbonylation: the effect of oxidative stress on proteins is evaluated based on the reaction of the carbonyl groups with dinitrophenylhydrazine (Levine et al., 1990) (Levine, RL; Garland, D.; Oliver, CN; Amici, A.; Climent, I.; Lenz, AG; Ahn, BW; Shaltiel, S.; Stadman ER Determination of carbonyl content in oxidatively modified proteins. Methods Enzymol, v. 186, p. 464-478, 1990; incorporated by reference in the present invention). In short, proteins are first precipitated with the addition of 20% trichloroacetic acid and dissolved in dinitrophenylhydrazine, and then absorbance is measured at 370 nm. Results are expressed as levels of carbonyls in protein per milligram of protein. One of skill in the art will note that other methods known in the art can optionally be used to assess protein carbonylation levels. c) extent of oxidative damage to the sulfhydryl group of proteins: oxidative damage of proteins is analyzed by characterizing damage to the groups sulfhydryl (previously described by: Aksenov et al. ( Aksenov, MY, Markesbery, WR Changes in thiol content and expression of glutathione redox system genes in the hippocampus and cerebellum in Alzheimer disease. NeurosciLett, v. 302, p. 141-145, 2001). Briefly, the proteins in the sample are precipitated and dissolved in dithionitrobenzoic acid. Absorbance is measured at 412 nm. The results are expressed as TNB levels per milligram of protein. A person skilled in the art will note that other methods are known in the art. technique can be used to assess the levels of oxidative damage in the sulfhydryl group of proteins. d) antioxidant activity of enzymes: the activity of cat alase (CAT) is determined by measuring the decrease in absorbance of hydrogen peroxide at 240 nm. Data is graphically represented as units per milligram of protein. Superoxide dismutase (SOD) activity is determined by inhibition of adrenaline auto-oxidation measured spectrophotometrically at 480 nm (described by Bannister, JV; Calabrese, L. Assays for superoxide dismutase. Methods Biochem Anal, v. 32, p. 279 -312, 1987) and expressed as units of activity per milligram of protein. One of skill in the art will appreciate that other methods known in the art can be used to assess levels of enzyme activity. e) determination of total proteins: all biochemical measurements can be normalized by protein content with bovine serum albumin as a standard with, for example, the methods described by Lowry, Rosebrough and Farr (Lowry, OH; Rosebrough, NJ; Farr, A. Protein measurement with the Folin phenol reagent. J BiolChem, v. 193, p. 265-275, 1951).
[0252] The individual benefits from at least one of the following effects, using a revelation device: pain reduction, increased muscle endurance, increased stamina, increased muscle strength, modulation of the cardiorespiratory system, such as increased capacity respiratory, increased flexibility, a modulation of cell metabolism, an improvement in analgesia, an antioxidative effect, an antifibromyalgia effect, a decrease in inflammation, a decrease in oxidative stress, a modulation of cytokine levels, a modulation of blood circulation, a reduction in intolerance to a cold environment, a reduction in a symptom of arthritis or vascular disease, an increase in skin perfusion, a decrease in heart rate, a decrease in blood pressure, faster recovery from injury or exercise, an aesthetic effect such as a reduction in the individual's cellulite and an improvement in the quality of life.EXAMPLE 20: Uses of bioceramics that emit infrared radiation distant look in the treatment of human fibromyalgia
[0253] Fibromyalgia is a chronic pain condition, often accompanied by diverse symptoms and predominantly affecting the musculoskeletal system. 2.5% of the Brazilian population is afflicted by fibromyalgia. According to recent epidemiological data, approximately 2% of the world population is affected by fibromyalgia. The main symptoms of fibromyalgia are associated with persistent pain that lasts more than three months, sleep disturbance, fatigue, anxiety, paraesthesia, headaches and tender points. There is an ongoing debate about the causes of fibromyalgia, however studies have raised the possibility that fibromyalgia is related to trauma, infections and stress causes.
[0254] Objective: This study evaluates the effects of articles of clothing impregnated with ceramic material/materials emitting infrared radiation compared to aquatic exercise on the symptoms and prognosis of patients diagnosed with fibromyalgia.
[0255] Study design: the present research is based on a blinded randomized clinical trial. It is designed to properly compare the effectiveness of different treatments; patients are randomly assigned to groups to avoid systematic errors. Subjects are randomized as follows (n = 25 per group): group 1: control group, not treated with hydrokinesiotherapy or bioceramics; group 2: is treated only with bioceramic materials; group 3: is treated only with hydrokinesiotherapy; group 4: is treated with hydrokinesiotherapy and bioceramics.
[0256] Treatment with hydrokinesiotherapy: exercises previously described by Berti et al. (2008) (BERTI, Gabriela et al. Hydrotherapy Applied to the treatment of Fibromyalgia: clinical and laboratory evaluation of patients treated at the Feevale University Center in Nova Humburgo - RS. Digital Journal of Educación Física y Desportes. n. 122, 2008; incorporated in the present invention by reference) are carried out, for example, in the pool under controlled temperature of the aquatic complex of UNISUL. Alternatively, the exercises can be performed in any suitable pool.
[0257] The exercises are performed in four phases, comprising 36 sessions of 1 hour each, three times a week per group. During the first phase, there may be global warming, followed by a straight line along the length of the pool, moving forward and sideways. The second phase can last about 15 minutes and may include active stretching of the upper and lower muscles, and sustaining for consecutive 20-second intervals. Exercise duration in the third phase is about 20 minutes, and the exercises are designed to be relatively free from activity in the upper and lower body. Finally, the fourth phase may consist of relaxation exercises, characterized by oscillatory movements, performed under the supervision of a physical therapist.
[0258] Conclusion: one or more of the parameters described in example 19 are used to determine the effectiveness of a bioceramic emitting far infrared energy in the treatment of human fibromyalgia. The hypothesis is that a revelation ceramic is effective in the treatment of humans with fibromyalgia.EXAMPLE 21: Randomized placebo-controlled trial to test the efficacy of a bioceramic as an adjunct to physical therapy in the treatment of chronic low back pain in humans
[0259] Low back pain (LBP) is a common complaint in today's society and is an important cause of discomfort in adults under 45 years of age. Debilitating low back pain that persists for more than 3 months is considered chronic. Chronic low back pain (CLBP) has many causes, which are treated with various methods, such as bed rest, lumbar support devices, traction, thermotherapy, electrical stimulation and manipulation, in most cases. Invasive treatment methods such as surgery, selective percutaneous root blocks, and epidural injection can be used to treat chronic low back pain.
[0260] Objective: The purpose of this study is to evaluate the effect of an article of clothing from the revelation that comprises a bioceramic that emits far infrared energy reflecting on the bioceramic to treat chronic low back pain.
[0261] Methods: The study is designed as a controlled clinical trial to test the efficacy of a far infrared radiation emitting ceramic sleeve or plaster as an adjunct to the physiotherapy treatment of chronic low back pain.
[0262] Intervention: Subjects will follow a regular physical therapy (PT) regimen treatment at the Wilfred R. Cameron Wellness Center in Washington, PA. Individuals will be randomly divided into 3 (three) experimental groups: a) control: receives only PT treatment.b) bioceramic plaster: receives PT treatment and uses a bioceramic plaster for “n” hours after treatment.c) placebo : receives PT treatment and uses a placebo patch (without bioceramics) for “n” hours after treatment hours after treatment.
[0263] Assessment of pain level and disability: The Oswestry Back Pain Disability Index (ODI); the Roland-Morris Low Back Pain and Low Back Pain Questionnaire and Roland-Morris Disability Questionnaire and the “Back Pain Index” (BAI) will be used to assess pain levels. The hypothesis is that a revelation plaster will be effective in the treatment of human beings with chronic low back pain.EXAMPLE 22: Uses of bioceramics that emit far infrared radiation in the treatment of human pain
[0264] An individual with chronic low back pain wears a padding material for revelation. The effectiveness of the quilted material was evaluated in a study described in example 21 or in another suitable study. An exemplary padded material for the treatment of chronic low back pain is the padded material shown in FIGURE 2, used as shown in FIGURE 10, either vertically or horizontally.
[0265] Intervention: The individual with chronic low back pain wears the padded material daily for approximately 6 consecutive weeks for 7 consecutive days. The quilted material provides an amount of infrared energy to the individual. The amount of infrared energy received by the individual is as follows (far infrared wavelength between 9 and 10 micrometers):* Screen-printed tissue with ink in a bioceramic concentration of 50%: irradiance of 4.05 milliW/cm2 at a temperature 36.5 °C body provides approximately 2.43 J/cm2 per hour of use.* Fabric screen-printed with ink at a bioceramic concentration of 30%: irradiance of 3.65 milliW/cm2 at a body temperature of 36 0.5 °C provides about 2.19 J/cm2 per hour of use.
[0266] Treatment provides relief for the individual with chronic low back pain.
[0267] The individual wants to prolong relief from chronic low back pain. The individual optionally consults with their physician or physiotherapist to discuss treatment options and regimens. The individual adjusts the treatment regimen to prolong the feeling of relief from using the patch for longer periods of time. The individual experiences prolonged relief from chronic low back pain.EXAMPLE 23: Uses of bioceramics that emit far infrared radiation in the treatment of carpal tunnel syndrome
[0268] Carpal tunnel syndrome (CTS) is an entrapment neuropathy that is primarily caused by median nerve compression and irritation at the carpal tunnel. Its symptoms include pain and paraesthesia in the wrist and hand, which may radiate to the forearm. CTS affects 1% to 3% of the population, with a higher incidence in certain occupational groups that perform repetitive hand and wrist movements.
[0269] Purpose: The purpose of this study is to evaluate the effect of a revelation garment comprising a bioceramic that emits far infrared energy reflecting bioceramics to treat carpal tunnel syndrome.
[0270] Methods: Pilot randomized placebo-controlled clinical trial to test the efficacy of a far infrared radiation emitting ceramic sleeve as an adjunct to the physiotherapy treatment of carpal tunnel syndrome.
[0271] Intervention: Subjects will follow a regular physical therapy (PT) regimen treatment at the Wilfred R. Cameron Wellness Center in Washington, PA. Individuals will be randomly divided into 3 (three) experimental groups: a) control: receives only PT treatment.b) bioceramic sleeve: receives PT treatment and uses a bioceramic plaster for “n” hours after treatment.c) placebo : receives PT treatment and wears a placebo sleeve (without bioceramics) for “n” hours after treatment hours after treatment.
[0272] Measured parameters: 1) Assessment of level of pain and disability: The Boston Carpal Tunnel Syndrome Questionnaire will be used to determine the effectiveness of a revealing sleeve in the treatment of carpal tunnel syndrome; and 2) assessment of grip strength (muscle strength): The grip strength of the affected dominant hand will be measured with a digital spring-loaded dynamometer (Baseline Smedley, USA) with individuals standing with their elbows extended. The hypothesis is that a revelation sleeve will be effective in treating humans with carpal tunnel syndrome.EXAMPLE 24: Uses of bioceramics that emit far infrared radiation in the treatment of human inflammation
[0273] Objective: The aim of this study will be to evaluate the effect of the revelation article of clothing, such as a shirt, a sleeve or a quilted material, comprising a bioceramic that emits far infrared energy corresponding to bioceramics for the treatment of inflammation.
[0274] Methods: The study will be designed as a controlled clinical trial to test the effectiveness of a far infrared radiation emitting ceramic sleeve or plaster as an adjunct to treat inflammation in humans, such as joint inflammation in humans with arthritis.
[0275] Type of study: interventionist. Subjects will be randomly divided into 3 (three) experimental groups: a) group 1: no treatment. b) group 2: wears an article of clothing from the revelation: a shirt, a quilted material or both, for “n” hours after treatment.c) group 3: uses a control garment that does not comprise any bioceramics, for “n” hours after treatment.
[0276] Parameter classification: the effectiveness of bioceramics in the treatment of inflammation will be determined based on the expression of the following cytokines: individually or in groups: TNF-α, IL-1β, IL-10 and IL-6. The absorbance for the aforementioned cytokines could be measured using a microplate reader at 450 and 550 nm. Human cytokine levels will be used to confirm the anti-inflammatory effect of the bioceramic compositions.EXAMPLE 25: Global Self-Reported Pain Levels, Global Health Levels, Global Fatigue, Global Sleep Quality, and Global Human Performance Levels Participating in a Zumba Fitness Program
[0277] An online questionnaire was used to assess the impact of bioceramic materials on individuals participating in a Zumba fitness program (ZUMBA®). Subjects were asked to identify how many times a week they practiced Zumba. Individuals who participated in Zumba classes were selected for further analysis. 10 individuals were asked to answer the following questions:
[0278] 1) “How would you rate your overall pain level in the last 2 weeks Check the number that best describes your pain. 1 = no pain, 10 = worse”. FIGURE 12 is a graph illustrating greater than 7.5% self-reported reduction in overall pain levels in human subjects treated with an article of clothing of the disclosure.
[0279] 2) “How would you rate your overall health level in the last 2 weeks Check the number that best describes your overall health level 1 = very good, 10 = very poor”. FIGURE 13 is a graph illustrating a self-reported improvement of more than 46% in overall health levels for human subjects wearing a reveal shirt when exercising in a Zumba fitness program.
[0280] 3) “How would you rate your overall level of fatigue in the last 2 weeks Check the number that best describes your overall fatigue 1 = very good 10 = very bad”. FIGURE 14 is a graph illustrating a self-reported reduction of more than 25% in overall fatigue levels in human subjects wearing a reveal shirt while exercising in a Zumba fitness program.
[0281] 4) “How would you rate the overall quality of sleep in the last 2 weeks Check the number that best describes your overall sleep 1 = very good 10 = very bad”. FIGURE 15 is a graph illustrating a self-reported improvement of more than 8.5% in overall sleep quality in human subjects wearing a reveal shirt while exercising in a Zumba fitness program.
[0282] 5) “How would you rate your overall performance level in the last 2 weeks Check the number that best describes your overall fatigue 1 = very good 10 = very bad”. FIGURE 16 is a graph illustrating a self-reported improvement of more than 7% in overall performance levels in human subjects wearing a reveal shirt when exercising in a Zumba fitness program.
[0283] Conclusion: Wearing a bioceramic revealing shirt reduces overall pain, improves overall health levels, reduces overall fatigue, improves overall sleep quality, and improves overall performance levels of humans participating in a program by Zumba Fitness.EXAMPLE 26: Report on Far Infrared Radiation Emission from Bioceramic Materials
[0284] Absolute emission report: according to the analysis of radiant energy emission in the infrared region in the range between 9 and 11 micrometers carried out at the Laboratory of the Spectroscopy and Laser of Exact Sciences Institute, of the Fluminense Federal University, the use of a Scientech calorimeter (Boulder, CO, USA), model 118, serial number 380802, connected to a Scientech power and energy measuring unit, model 473, serial number 364002, in the following materials: 1) smooth fabric (other than includes a bioceramic); 2) bioceramic tissue (30% bioceramic), the bioceramic formulation was as described in example 1; 3) bioceramic tissue (50% bioceramic), the bioceramic formulation was as described in example 1 .
[0285] The emissivity analysis was based on the Stefan-Boltzmann equation given by: P = esT4 where P is the radiant energy per unit area (Watts/m2), c is the wafer emissivity (without units), a is the Stefan-Boltzmann constant (5.7 x 10-8 W/m2K4) and T is the temperature of the materials in degrees Kelvin. The emissivity of the material and a dimensionless quantity is a material property, it concerns the capacity of emitting energy by radiation from its surface. It is the ratio of energy radiated by the particular material of the urn to the energy radiated relative to the dark-body urn (e = 1). Any object that is not a dark body actually has an emissivity of less than 1 and greater than zero.
[0286] For the analysis, the materials were cut into 15 mm diameter disks and placed in a thermally insulated oven and kept electronically at these temperatures (with a variation of ± 1 °C). Once in thermal equilibrium, the oven/disk assembly was positioned in front of the calorimeter and the radiation measurement was performed.
[0287] The potential measurements per square meter for each material are adjusted as a function of temperature at a high fourth power of the Kelvin temperature. The emissivity value is calculated from the slope of the straight line fitted by the least squares method performed using the free domain QtiPlot program.
[0288] The results obtained are as follows: 1) smooth tissue (which does not include a bioceramic): 0.68 emission (FIGURE 17) 2) bioceramic tissue (30% bioceramic): 0.70 emission (FIGURE 18)3) bioceramic tissue (50% bioceramic): emission of 0.74 (FIGURE 19)
[0289] The results correspond to the mean value of the measurements; an average of five measurements was performed for each material, with an estimated error of ± 0.02. In the tested samples, the addition of bioceramic materials increased the absolute emissivity of the materials, which confirms the higher spectral emission of far infrared radiation in the range of 9 to 11 micrometers.EXAMPLE 27: Uses of bioceramics emitting far infrared energy improves flexibility, increase back, leg and grip strength, improve respiratory capacity and improve cardiorespiratory fitness.
[0290] Objective: The aim of this study will be to evaluate the effect of the article of clothing of the revelation on improving flexibility, increasing back, leg and grip strength, improving respiratory capacity and increasing cardiorespiratory fitness in a human being.
[0291] Methods: The study will be designed as a double-blind controlled clinical trial to test the statistical impact of a far infrared emitting bioceramic shirt, sleeve, or plaster on improving flexibility, increasing back, leg endurance, and leg strength. prehension, improved respiratory capacity and increased cardiorespiratory fitness in humans.
[0292] Type of study: interventionist. Individuals will be randomly divided into 3 (three) experimental groups and will receive treatment for at least 6 weeks: a) group 1: no treatment. b) group 2: wears a revealing garment: a shirt, a quilted material, or both, for “n” hours after treatment. c) group 3: wears a control garment that does not comprise any bioceramics, by “n” hours after treatment. “n” hours may be 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 or 24 hours in the course of a day.
[0293] Parameter classification: flexibility, back endurance, legs and grip strength, respiratory capacity and cardiorespiratory fitness will be measured as previously described in examples 11, 13, 14, 19 and 20.EXAMPLE 28: Uses of bioceramics that emit Far infrared energy as an analgesic in mice
[0294] Objective: The aim of this study was to evaluate the analgesic effects of different concentrations of bioceramic and treatment times in an experimental model of CFA-induced inflammation in mice.
[0295] Methods: Experiments were carried out using adult male Swiss mice weighing 25 to 35 g, housed at 22 °C, under a 12h light/12h dark cycle (lights on at 6:00), with access to food and water ad libitum. The experiments were carried out after approval of the protocol by the Ethics Committee of the University of Southern Santa Catarina (UNISUL). The animals (n = 8) underwent intraplantar injection (right hind paw) of a solution containing 20 μL of Freud's complete adjuvant (CFA, 70%). Virgin animals were injected with saline solution. The mechanical nociceptor threshold was evaluated as the response frequency to 10 presentations of a 0.4 g von frey filament applied to the animals' right hind paw.
[0296] In experiment number 1, the animals were placed in their housing boxes for 2 hours on top of: (1) a padded material composed of 70% BioCorn PVC and 30% bioceramic; (2) a padded material composed of 90% BioCorn PVC and 10% bioceramic; or (3) a padded material composed of 100% BioCorn PVC and 0% Bioceramic. After 2 h of exposure, the mechanical nociceptor threshold was assessed. Virgin animals were not treated.
[0297] In experiment number 2, the animals were placed in their housing boxes on top of a padded material composed of 70% BioCorn PVC and 30% bioceramic, for 0.5, 1 or 2 hours. Thereafter, the mechanical nociceptor threshold was assessed. Virgin animals were not treated.
[0298] Results: The results show that i.pl. injection; of CFA induced mechanical hypernociception (P < 0.001) which was significantly reduced by acute exposure to padded material containing bioceramics. Exposure to padded material with a higher concentration of bioceramic induced longer lasting results (FIGURE 20, table A). Longer exposure to the quilted bioceramic material induced longer lasting results (FIGURE 20, Table B).
[0299] Conclusion: exposure to quilted bioceramic material reduced mechanical hypernociception of inflammatory origin induced by intraplantar injection of CFA in mice, in a dose-dependent manner.EXAMPLE 29: Effect of bioceramics on the growth of organic products
[0300] Objective: to evaluate the effect of BioPower® on the growth of hydroponic lettuce (Lactuca sativa).
[0301] Methods: experiments were carried out with lettuce (Lactuca sativa), grown in a hydroponic system. The control group was cultured according to standard hydroponics methodology. The experimental group (bioceramics) was treated with bioceramic pellets (30% bioceramic, 70% polystyrene-polypropylene - 1 pound) placed inside the water pump. Lettuce was grown for 3 weeks and collected for analysis.
[0302] Results: The results indicate that the lettuce that received water treated with bioceramics had greater weight and had more leaves compared to the control group. Figure 21 is non-limiting graphs illustrating the effect of adding bioceramics of the present disclosure to a water treatment in a hydroponic system. n = 12, vertical lines indicate standard error of means * p < 0.05.
[0303] Electrical conductivity (EC) (displayed in microsiemens (μS)) is a measure of the ability of nutrient solutions to conduct an electrical current. Pure (deionized) water is an insulator. It is the conductive substances (or ionized salts) dissolved in water that determine the conductivity of the solution. With few exceptions, when there is a higher concentration of nutrients, the electrical current will flow faster, and when there is a lower concentration, the current will flow more slowly. This is because the amount of dissolved solids in the nutrient solution is directly proportional to the conductivity. Thus, by measuring EC, it is possible to determine how strong or how weak the concentration of the nutrient solution is. In this case, a low electrical conductivity in the experimental group (BioPower group) denotes a lower concentration of nutrients in the solution, which may suggest that the plants treated with BioPower absorbed more nutrients than the plants in the control groups. Figure 22 is a graph illustrating the lower electrical conductivity of water treated with bioceramics presented from day 16 to day 20 compared to the control group (water only). FIGURE 23 are photographs showing lettuce at the beginning of treatment - 1st day in the system (FIGURE 23, table A); lettuce after the first week of treatment (FIGURE 23, panel B); lettuce after the third week of treatment (FIGURE 23, table C); and a photograph of the bioceramic pellets used in the experiment (FIGURE 24).EXAMPLE 30: Randomized, double-blind, placebo-controlled clinical study on the effect of bioceramics that emit far infrared energy in humans participating in exercise or exercise programs fitness
[0304] Purpose: To investigate the effect of far infrared (cFIR) emitting ceramic garment on humans participating in exercise or Zumba fitness (ZUMBA®) programs.
[0305] Background: bioceramics are refractory, inorganic and non-metallic polycrystalline compounds that, due to their inertness in aqueous conditions, are highly biocompatible and have been extensively used in implants. The bioceramic fabrics and article of clothing disclosed in the present invention have been optimized for their ability to reflect/emitting far infrared radiation (FIR). The aim of this study is to evaluate the effect of tissues comprising bioceramics along with exercise or fitness programs in humans.
[0306] Design: Randomized double-blind placebo-controlled trial. Demographics: The study will include male and female subjects of various ages.
[0307] Intervention: Humans will participate in exercise or Zumba fitness (ZUMBA®) programs. All human subjects will participate in exercise or Zumba fitness programs at least once a week. Subjects will be randomly divided into three experimental groups:• Group 1 (no treatment control - plain article of clothing): subjects in this group will wear plain control shirts and/or leggings during exercise or Zumba fitness programs.• Group 2 (placebo control - shirt and/or leggings (pants) comprising a ceramic that does not reflect energy or infrared rays): individuals in this group will wear control shirts and/or leggings (pants), which comprise a ceramic that does not reflect energy or infrared rays during exercise programs or Zumba fitness.• Group 3 (Experiment - shirt and/or leggings (pants) comprising 50% by weight of the following bioceramic composition: about 18% aluminum oxide Al2O3, about 14% silicon dioxide SiO2, about 50% kaolinite (Al2Si2O5(OH)4), about 8% zirconium oxide (ZrO2) and about 10% tourmaline (NaFe2+3Al6Si6O18(BO3)3 (OH)3OH)). Individuals in this group will wear shirts and/or leggings (pants) comprising said bioceramics during exercise or Zumba fitness programs. Experiments measuring the amount of infrared energy emitted by the aforementioned apparatus were revealed in EXAMPLE 26. Additional experiments measuring the amount of infrared energy emitted by shirts before, during, and after individuals participate in exercise or Zumba fitness programs will be performed.
[0308] Assessments: The following assessment methods will be used to measure the effect of tissues comprising bioceramics on humans in conjunction with exercise or fitness programs:
[0309] Body composition: body mass index (BMI) and waist circumference: percentage of fat will be measured using the skinfold method or using bioelectrical impedance analysis (BIA). Body composition will be assessed at least twice: 1) a baseline assessment will be performed prior to initiation of interventional and control testing; and 2) at least one follow-up assessment will be performed at the end of a six-week period after the start of the intervention.
[0310] Cardiovascular Conditioning: The Harvard Step Test will be used to measure “aerobic” or “cardiovascular” fitness. The Harvard Step Test is an art-recognized method for measuring how oxygen consumption increases with exercise intensity. VO2max is defined as the highest rate of oxygen consumption achievable during maximal or exhaustive exercise.• Harvard Step Test Protocol: Participant ascends and descends a ladder at a rate of 30 completed steps per minute (one second up and one second second down) for 5 minutes or until exhausted. Exhaustion is defined as when the participant cannot maintain the stride rate for 15 continuous seconds. The subject immediately sits down upon completion of the test, and the subject's total number of heartbeats is contacted, based on their pulse, at the following time intervals: a) from one minute to one and a half minutes after completion; b) from two minutes to two and a half minutes after the thermal; and c) from three minutes to three and a half minutes after completion.
[0311] Cardiovascular fitness will be assessed at the end of exercise or Zumba fitness (ZUMBA ®) classes: 1) a baseline assessment will be performed prior to initiation of interventional and control testing; and 2) follow-up assessments will be performed at the end of exercises or Zumba fitness classes (ZUMBA ®). The individuals' aptitude index score will then be determined by the following equations: Aptitude index = (100 x test duration in seconds) divided by (2 x sum of heartbeats in recovery periods).
[0312] Flexibility: The flexibility of each human is measured with the sit and reach test (Novel Flex-Tester® sit and reach box). For evaluation, each individual will be asked to sit on the floor with their knees against the floor, and with the flat box placed against the plantar surface of their feet. Then the subject stretches and reaches towards the box, moving the index finger as far as possible. The average of the 3 measurements will be used in the analysis. Flexibility will be assessed at the end of exercise or Zumba fitness (ZUMBA ®) classes: 1) a baseline assessment will be performed prior to the start of interventional and control tests; and 2) follow-up assessments will be performed at least once a week for a total of six weeks at the end of the exercises or Zumba fitness classes (ZUMBA ®).
[0313] Back and Leg Strength: The Back/Leg Dynamometer (Baseline, USA) will be used to measure leg and back muscle strength. Leg muscle strength will be recorded in an upright position while both knees are bent at a 135° angle. To assess back muscle strength, the participant is asked to stand on the device platform with the knees bent at a 135° angle. Using an overhand grip, the participant grasps the device's cable bar and slowly straightens their legs to their maximum level, without using their back or shoulder muscles. For back muscle strength assessments, subjects are asked to repeat the procedure described using only their back muscles (knees are kept straight). Flexibility will be assessed at the end of exercise or Zumba fitness (ZUMBA ®) classes: 1) a baseline assessment will be performed prior to the start of interventional and control tests; and 2) follow-up assessments will be performed at least once a week for a total of six weeks at the end of the exercises or Zumba fitness classes (ZUMBA ®).
[0314] Questionnaires: subjects will optionally be asked to answer questionnaires that aim to assess the effects of the intervention on parameters associated with: general health, sleep, pain, perception of well-being or quality of life. Exemplary questionnaires include: brief health research questionnaire (SF-36); the Pittsburgh Sleep Quality Index (PSQI); the McGill Pain Questionnaire; a wellness questionnaire; the WHO Quality of Life Questionnaire (WHOQOL-BREF); the questionnaire described in EXAMPLE 25 and/or several variations thereof.EXAMPLE 31: Randomized, double-blind, placebo-controlled clinical study on the effect of bioceramics that emit far infrared energy in humans participating in exercise or fitness programs
[0315] Objective: To evaluate the effect of far infrared radiation (cFIR) emitting ceramic shirts on physical fitness parameters.
[0316] Methods: Each participant is randomly divided into 2 (two) experimental groups: • Experimental group I (cFIR shirts): each participant wears a cFIR shirt for a minimum period of four hours after engaging in physical exercise, and one minimum of 4 hours per day between exercise days.• Experimental group II (placebo shirts): participants wear a placebo shirt (without cFIR) for a minimum period of 4 hours after the exercise protocol and a minimum of 4 hours daily between exercise days.
[0317] Type of study: randomized, double-blind, placebo-controlled clinical trial
[0318] Fitness Program: Subjects will participate in a 1-hour Pilates workout, 3 times a week. The standardized and progressive treatment protocol will address muscle activation strategies through a variety of movement patterns that involve muscle activation strategies through a variety of movement patterns, involving muscle extension/contraction. In the protocols, participants will be asked to intentionally recruit specific muscle groups in a variety of movement patterns to exercise all major muscle groups and increase overall fitness.
[0319] Sample size and population: the results of experimental group I (with cFIR shirts) and experimental group II (placebo shirts) will be compared. A reasonable number of individuals needed to provide a = 0.05 with a power of 0.95 is estimated in a total of 62 individuals divided between the two experimental groups (31 individuals in each group). The required number of subjects was calculated with G*power Statistical Power Analyzes version 3.1 (Heinrich-Heine-Universitât Düsseldorf, Germany) and is as follows:• Analysis: a priori• Input data: effect size f = 0, 35 / α err propb = 0.05 / force (1-β err prob) = 0.95 / number of groups = 2 / number of measurements = 9 / rep measurements between correlation = 0.5• Output data: parameter of non-centrality À = 13.6710000 / F critical = 4.0011914 / numerator df = 1.0000000 / denominator df = 60.0000000 / total sample size = 62 / effective force = 0.9532935
[0320] Randomization: Participants will be randomly assigned to each group. A search assistant will generate random numbers using search randomizer software. These numbers will be stored on a computer and will only be accessible by the wizard. No layering or blocking strategies will be used.
[0321] Number and frequency of suggested assessments: A baseline assessment is performed prior to the start of the study, followed by a weekly assessment for a total of 6 (six) weeks (minimum). Measured Parameters:A) Functional capacity :
[0322] Balance: the static balance of each human being is measured using a pressure plate (stabilometric exam) (Medicapteurs®, model S-Plate®). The platform records center of pressure (COP) deviations in the anteroposterior and mediolateral directions. Data acquisition is performed for 30 seconds under the following conditions: 1) condition 1: human subjects keep their eyes open during measurements; Condition 2: Human subjects keep their eyes closed during measurements.
[0323] Cardiorespiratory capacity: the oxygen consumption (V02) of each human is calculated with a regression equation, as taught by King et al (J Rheumatol 1999; 26: 2233-7).B) Body composition:
[0324] Body mass index, fat mass index, skeletal muscle mass index, body fat percentage: are calculated with bioelectrical impedance analysis.C) Far infrared radiation emissivity of human subjects wearing the bioceramic garment :
[0325] Human subjects are photographed before, during and after the exercise protocol with an infrared thermographic camera (Flir E6 IR camera, FLIR Systems, Inc). Far infrared radiation images are used to determine changes in body temperature caused by cFIR emissions and/or physical activity. D) Far infrared radiation emissivity of shirts and other articles of bioceramic garments:
[0326] The emissivity of jackets is measured with the Astral S-series AC2500S calorimeter connected to a portable meter (Astral AI310 (Scientech, Boulder, CO, USA) The emissivity of far infrared radiation of bioceramic jackets with a calorimeter is used for determine the FIR emissivity of the shirts in real time. Assessments are performed before and after the human participates in the exercise protocol (pilates class). Assessments are optionally performed during gym class. E) Blood/saliva samples will be collected for biochemical analysis (muscle stress markers/inflammation markers/oxidative stress markers):
[0327] Muscle stress markers: creatine kinase (CK) and lactate dehydrogenase (LDH).
[0328] Markers of inflammation: interleukin (IL)-10, IL-6, Il-1b and tumor necrosis factor (TNF)-a.
[0329] Oxidative stress: thiobarbituric acid reactive substances (TBARS), carbonylated proteins, catalase (CAT) and superoxide dismutase (SOD)F) Questionnaires:
[0330] The following questionnaires will be used to obtain a personal assessment of each individual: a) the modified Borg scale of perceived exertion (RPE); b) the Pittsburgh Sleep Quality Index (PSQI); c) WHO quality of life questionnaire (WHOQOL-BREF)EXAMPLE 32: Comparison of a developing bioceramic with a different bioceramic composition embedded in an UnderArmour Cold Gear jacket.
[0331] Purpose: to compare the analgesic effect of a bioceramic of the claims against a far infrared emitting (cFIR) bioceramic formulation provided by UnderArmourTM (UA) in a mouse model of mechanical hypersensitivity induced by CFA. The mouse model of CFA is further described in EXAMPLES, 15, 16, and 18.
[0332] Evaluation of mechanical hypersensitivity: experiments were performed using adult male Swiss mice weighing 25 to 35 g, housed at 22 °C, under a 12h light/12h dark cycle (lights on at 06:00), with access to food and water ad libitum. The animals (n = 8) underwent intraplantar injection (right hind paw) of a solution containing 20 μL of Freud's complete adjuvant (CFA, 70%) to induce mechanical hypersensitivity.
[0333] For treatment, the screen-printed tissue comprising a far infrared emitting bioceramic of the revelation or a formulation described by UnderArmourTM was placed in the lower part of the animals' boxes. After 2 h of exposure to bioceramics, the mechanical nociceptor limit of each animal was assessed as the response frequency of 10 presentations of a 0.4 g von frey filament applied to the animals' right hind paw.
[0334] Results: CFA-induced mechanical hypernociception in mice was significantly reduced by exposure to a tissue comprising a developing bioceramic, the bioceramic comprising from about 40% by weight to about 60% by weight of kaolinite (Al2Si2O5(OH) )4), from about 5% by weight to about 15% by weight of tourmaline, from about 15% by weight to about 25% by weight of aluminum oxide (Al2O3), from about 10% by weight to about 20% by weight of silicon dioxide (SiO2) and from about 1% by weight to about 20% by weight of zirconium oxide (ZrO2). CFA-induced mechanical hypernociception in mice was not reduced by exposure to a tissue comprising a bioceramic formulation described by UnderArmourTM. The analgesic effect lasted up to 2 hours.
[0335] FIGURE 24 is a graph illustrating the analgesic effect of a far infrared (cFIR) emitting bioceramic of the revelation compared to an UnderArmour™ formulation in the CFA mouse model of induced mechanical hypersensitivity. N = 8 mice per group, vertical lines indicate standard error of means * p < 0.05.
[0336] Conclusion: A developing bioceramics reduced the mechanical hypersensitivity induced by CFA footpad injection, while a different formulation did not provide the analgesic effect.EXAMPLE 33: Infrared Transmittance of Bioceramics.
[0337] Purpose: to compare the infrared transmittance of a bioceramic of the present disclosure (comprising 18% aluminum oxide, 14% silicon dioxide, 50% kaolinite, 8% zirconium oxide and 10% tourmaline) to a distinct bioceramic composition (including 20% aluminum, 3% titanium, 11% magnesium oxide, 6% ferric trioxide and 60% silica).
[0338] Methods: The infrared transmittance of powder samples (particle size = about 25 micrometers) of bioceramic powders was taken using a Bruker spectrometer (Spectrum model VERTEX 70, OPUS 6.5) software. Transmittance rates (%) were determined with a resolution of 4 cm-1 and 72 scans, at a scan range from 350 cm-1 to 4000 cm-1.
[0339] Figure 25A illustrates the infrared transmittance of a bioceramic composition of the present disclosure, comprising 18% aluminum oxide, 14% silicon dioxide, 50% kaolinite, 8% zirconium oxide and 10% tourmaline. Figure 25B illustrates the infrared transmittance of bioceramic compositions comprising 20% aluminum, 3% titanium, 11% magnesium oxide, 6% ferric trioxide and 60% silica. Far infrared emitting bioceramics in human subjects with fibromyalgia undergoing hydrotherapy.
[0340] Objectives: To investigate the effect of far infrared emitting bioceramic garment on the following parameters of human subjects afflicted with fibromyalgia: a) heart rate; b) performance-based functional exercise capacity, c) balance, d) level of global perceived pain, e) questionnaires related to the impact on fibromyalgia, pain, quality of life and health; f) blood levels of inflammatory and anti-inflammatory cytokines and g) blood levels of oxidative stress markers and antioxidative enzyme activity.
[0341] Study design: double-blind placebo-controlled trial.
[0342] Intervention: Participants followed a regimen of hydrotherapy exercise 3 times a week for a period of 6 weeks and were randomly divided into 2 groups (placebo and bioceramics). Subjects in the placebo group wore “fake article of clothing,” that is, human subjects wore shirts that did not have far infrared radiation emitting properties (shirts without bioceramics). Subjects in the bioceramics group wore a shirt comprising bioceramics every night at bed (6 to 8 hours), for 6 consecutive weeks, and also during hydrotherapy sessions. Each hydrotherapy session consisted of four phases, namely, (1) warm-up: participants were asked to walk the length of the pool back and forth; (2) active stretching of the upper and lower limbs; (3) active exercise of the upper and lower limbs; and (4) relaxation exercises through oscillatory movements. All phases were guided by the therapist.
[0343] Population and sample size: 16 participants: 8 women in each group, with uniform age distribution. All participants were women.
[0344] Assessments: Assessments were performed to assess the following parameters: flexibility, grip strength, heart rate, pain, performance and functional exercise capacity. The results listed below describe the data obtained in the first 6 consecutive weeks of evaluations:
[0345] A) Heart rate: a heart monitor was used to assess the flexibility of human subjects. Number of Assessments: A baseline assessment was performed prior to the start of testing. Follow-up assessments were performed before and after each hydrotherapy session (3 times a week for 6 weeks). The results of this test are illustrated in FIGURE 26 and discussed below.
[0346] B) Performance-based functional exercise capacity: the six-minute walk test (6MWT), which measures the distance an individual is able to walk in a total of six minutes on a hard, flat surface was used. to assess the functional exercise capacity of human subjects. Number of Assessments: A baseline assessment was performed prior to the start of testing and 6 weeks after the start of testing. The results of this test are illustrated in FIGURE 26 and discussed below.
[0347] Figure 26 is a graph illustrating the effect of far infrared emitting bioceramic garment on heart rate and functional exercise capacity based on performance of human subjects afflicted with fibromyalgia after a hydrotherapy treatment regimen. Baseline assessments were performed once a week, prior to any intervention. Tables A and B of FIGURE 26 illustrate the cumulative effect of the far infrared emitting bioceramic garment on heart rate over a 6 week period before and after hydrotherapy, respectively. Table C of FIGURE 26 illustrates the performance-based measure of functional exercise capacity in relation to the total distance covered in meters over a 6-minute period. Baseline assessments were performed once a week, prior to any intervention. * p < 0.05 indicates a statistically significant difference between groups. (paired t-test with 95% confidence interval - Graphpad Prism software, USA, 2014).
[0348] C) Balance: a stabilometry/baropodometry platform (S-plate - Medicapteurs, France) was used to assess the balance of human subjects. Number of assessments: A baseline assessment was performed prior to initiation of testing and follow-up assessments were performed after 6 weeks of treatment. FIGURE 27 is a graph illustrating the effect of the far infrared emitting bioceramic garment on the balance of fibromyalgia patients following a hydrotherapy treatment regimen. FIGURE 27 demonstrates that hydrotherapy, together with the use of a control garment, did not affect the individuals' balance, while the use of far-infrared emitting bioceramics statistically reduced the lateral-lateral oscillations. FIGURE 27 illustrates the cumulative results over a 6 week period. *p < 0.05 indicates a statistically significant difference between groups. (paired t-test with 95% confidence interval - Graphpad Prism software, USA, 2014).
[0349] D) Perceived global pain level: visual analogue scale (VAS) was used to assess pain levels. Number of Assessments: A baseline assessment was performed prior to the start of testing. Follow-up assessments were performed before and after each hydrotherapy session (3 times a week for 6 weeks). * p < 0.05 indicates a statistically significant difference between groups. Baseline assessments were performed once a week, prior to any intervention. (paired t-test with 95% confidence interval - Graphpad Prism software, USA, 2014). Figure 28 is a graph illustrating the effects of the global perceived pain level of human subjects afflicted with fibromyalgia who are treated with a far infrared emitting bioceramic garment or a fake garment. The results shown in FIGURE 28 suggest that: (1) hydrotherapy, together with the use of the fake garment or the garment comprising a bioceramic, reduced the patients' overall pain levels (compare baseline before and after for each group - statistical significance not shown in the photo). (2) The results suggest a chronic (cumulative) effect of the combined treatment.
[0350] E) Questionnaires related to the impact of fibromyalgia, pain, quality of life and health: The fibromyalgia impact questionnaire (FIQ), the McGill pain questionnaire and the McGILL descriptor index, and the SF- 36 (Index of physical functioning, pain and general condition) were used to assess the impact of a far infrared emitting bioceramic on fibromyalgia, pain, quality of life and other health-related aspects. Number of assessments: A baseline assessment was performed before the start of testing and after 6 weeks. FIGURE 29A is a graph illustrating the results of the Fibromyalgia Impact Questionnaire (FIQ) (TABLE A), the McGill Pain Questionnaire (TABLE B), and the McGILL Descriptor Index (TABLE C). *p < 0.05 and ** p < 0.01 indicate a statistically significant difference between groups. Baseline assessments were performed once a week, prior to any intervention. (paired t-test with 95% confidence interval - Graphpad Prism software, USA, 2014).
[0351] The results depicted in FIGURE 29A indicate that: (1) hydrotherapy together with the use of placebo (false) jackets or bioceramic jackets had a positive effect on the FIQ score, although the use of infrared emitting bioceramic jackets distant in combination with hydrotherapy was more effective than hydrotherapy alone (placebo shirt). (2) the use of only bioceramic shirts statistically affected McGill's pain index and descriptors. Note that the lower the score, the better the result. FIGURE 29B is a graph illustrating the results of an SF-36 questionnaire; physical functioning (CHART A), pain (CHART B) and general index (CHART C). Baseline assessments were performed once a week, prior to any intervention. (paired t-test with 95% confidence interval - Graphpad Prism software, USA, 2014). The results described in FIGURE 29B indicate that hydrotherapy, together with the use of placebo or far infrared emitting bioceramic shirts has a positive effect on SF-36 pain, as well as on the global index, whereas the use of bioceramic shirts statistically affected all three scores. Note that the score can range from zero to 100, and the lower the score, the worse the prognosis.
[0352] F) blood levels of inflammatory and anti-inflammatory cytokines. Enzyme-linked immunosorbent assay (ELISA) was used to assess blood levels of inflammatory and anti-inflammatory cytokines. Number of Assessments: A baseline assessment was performed prior to the start of testing. Follow-up assessments were performed before and after each hydrotherapy session (3 times a week for 6 weeks).
[0353] G) blood levels of oxidative stress markers and antioxidant enzyme activity. Enzyme-linked immunosorbent assay (ELISA) was used to assess blood levels of inflammatory and anti-inflammatory cytokines. Number of Assessments: A baseline assessment was performed prior to the start of testing. Follow-up assessments were performed before and after each hydrotherapy session (3 times a week for 6 weeks).EXAMPLE 35: Effect of far infrared emitting bioceramic garment on postural sway in judo athletes.
[0354] Background: Postural control has been defined as the control of the position of the body in space for the purposes of balance and orientation. Postural stability/balance is an essential component in evaluating the effectiveness of interventions to improve balance.
[0355] Objectives: To determine the effects of fabrics impregnated with far infrared radiation emitting ceramic material on postural sway in college judo wrestlers.
[0356] Design: randomized, single-blind, placebo-controlled trial. 17 volunteers, male and female, who were randomly allocated to an experimental group (cFIR group, formed by 4 fighters and 4 fighters who were invited to wear T-shirts with FIR-emitting ceramic material for five months); and a control group (non-cFIR group formed by 5 wrestlers and 4 wrestlers who were asked to wear fake/placebo shirts, ie, those that were not impregnated with cFIR-emitting ceramic material). Randomization numbers were generated from a randomization site (randomization.com).
[0357] Participants: A total of seventeen judo wrestlers (nine men and eight women) participated in the present study. The following inclusion criteria were considered: (1) each human had to participate in official judo competitions during the calendar year; (2) each individual had to train at least three times a week; (3) each human should be between the ages of 18 and 35 years; (4) and each human had to have been practicing judo for at least 10 years. The following exclusion criteria were considered: (5) individuals who had a history of musculoskeletal injuries in the hips, knees, or ankles within the previous 2 months; individuals who used pharmacological agents or nutritional supplements; who had musculoskeletal injuries during the study or who did not wear the shirt for a minimum of 4 hours a day were excluded from the study. All participants were competing in competitions nationwide.
[0358] Bioceramics and Garment: The experimental group wore a shirt impregnated with FIR-emitting bioceramic material. The bioceramic material was mixed with a textile paint (Silkscreen Plastisol, Imagine Color, Brazil) and was applied to the bioceramic garment, ie the t-shirts. Bioceramic ink was used to screen a repetitive pattern onto a 92% polyester and 8% lycra fabric, which was used to impregnate the shirts with bioceramic. The fake shirts were screen-printed using the same pattern, albeit with 100% plastisol ink (no far infrared emitting ceramic powder). The mean absolute emissivity of the ceramic powder was 93% at wavelengths from 9 to 11 µm, determined with a Scientech calorimeter (Boulder, CO, USA), model S series AC2500S Astral, connected to a Scientech detection unit, S series model AI310D Astral. The control group wore a placebo shirt (without FIR-emitting ceramic material).
[0359] Interventions: Participants were instructed by a blindfolded researcher to wear one of the shirts for four (4) hours daily during workouts (which includes aerobic training, weight lifting and wrestling classes) during the experiments. The intervention lasted five months, with the daily use of bioceramic shirts (4 hours during exercises). Static balance (stabilometry) was assessed before and after the intervention. The training protocol consisted of a 2-hour focus of physical preparation in the morning and a 2-hour tatami-specific technical training in the afternoon, 5 days a week. FIGURE 30 is a flowchart of the organization describing the study setup.
[0360] Parameters: advances in technology have provided the scientific community with computerized platform systems for the quantitative assessment of static balance. These systems provide an easy, practical and cost-effective method to quantitatively assess functional balance by analyzing postural sway. Such systems record the displacements of the center of pressure of the foot (COP) through sensors embedded in the platform structure. COP movements reflect both the horizontal location of the center of gravity (COG) and ground reaction forces due to lower limb muscle activity transmitted through the foot. Body balance can be measured as the persistent sway of the center of mass (COM), referring to the anteroposterior (AP) and mediolateral (ML) axes.
[0361] Statistical analysis: For statistical analysis, the Kolmogorov-Smirnov test was used to determine the sample distribution, using the parametric test in the analysis of pressure plate data. Paired and unpaired t tests were used for intra- and between-group comparisons, respectively. The GraphPad prism program (version 5.0, Mac OS) was used for statistical analysis, with the significance level set at 5% (p < 0.05).
[0362] Results: The total length and area of oscillation of the center of pressure of the foot (COP) were significantly reduced after treatment in the experimental group, with different degrees of reduction when the eyes are open (p < 0.05) , but not closed (p > 0.05). In addition, the experimental group exhibited a reduction in COP mediolateral and anteroposterior (width) deviations after treatment in the open-eyed analysis.
[0363] Analyzes were performed for 25 participants (FIGURE 30). The anthropometric characteristics of the participants are shown in TABLE 1. There was no statistically significant difference between the groups for personal characteristics.

[0364] Figure 31 is a graph illustrating the effect of far infrared emitting bioceramic garment on postural control. FIGURE 31 displays the results of variables before and after treatment with placebo FIR or with FIR, with values expressed as mean and standard deviation. The length and total area of sway of the COP were reduced after treatment in the experimental group, with different degrees of reduction when the eyes were open (p < 0.05) but not closed (p > 0.05). A reduction in body sway in the control group after placebo treatment with eyes open and closed (p > 0.05) was not observed. These results demonstrate that FIR interventions led to less body sway and, consequently, to greater orthostatic control.
[0365] In addition, as shown in TABLE 2, the experimental group exhibited a reduction in the mediolateral and anteroposterior (width) deviations of the COP, after the open-eye analysis treatment, thus demonstrating greater orthostatic control, while no difference significant was found in the control group (p > 0.05). The mean velocity analyzes of the mediolateral and anteroposterior deviations did not reveal statistically significant differences between the groups (p > 0.05).

[0366] TABLE 3 shows that FIR treatment had no effect on orthostatic control in mediolateral and anteroposterior shifts in all parameters analyzed in humans with eyes closed (mean width and speed) compared to placebo FIR.


[0367] Conclusion: These results demonstrate that the FIR intervention led to less body sway and, consequently, greater orthostatic control. The results obtained in the present invention suggest that FIR garments may find practical clinical applications in balance disorders, or even for garments that improve performance in leisure activities and competitive sports.EXAMPLE 36: Effect of the garment of far infrared emitting bioceramics in human subjects under a Pilates exercise regimen.
[0368] Objectives: To investigate the effect of far infrared emitting ceramic garment on flexibility, grip strength, balance, heart rate variability and sleep quality.
[0369] Study design: double-blind placebo-controlled trial.
[0370] Intervention: Participants followed a one-hour beginners' pilates protocol three times a week for an eight-week period and were randomly assigned to 2 different groups (placebo and bioceramics). The placebo group wore a fake far infrared radiation emitting ceramic shirt (no bioceramics) while the participants in the bioceramic group wore a bioceramic shirt that emits far infrared energy for 8 weeks every night during sleep (6 to 8 hours ).Assessments:
[0371] Population and sample size: 30 participants: 15 individuals in each group. Uniform distribution between sexes/ages.
[0372] Flexibility: The sit and reach bench test was used to measure flexibility. A baseline assessment was performed before the start of testing and before each pilates session (3 times a week for 8 weeks). Grip strength: A portable dynamometer was used to measure grip strength. A baseline assessment was performed before the start of testing and before each pilates session (3 times a week for 8 weeks). Balance: balance was assessed with a stabilometry/baropodometry platform (S-plate - Medicapteurs, France). A baseline assessment was performed before the start of testing and after six weeks.
[0373] Figure 32 is a graph illustrating the effect of the far infrared emitting bioceramic garment on the flexibility and grip strength of Pilates practitioners. Baseline assessments were performed once a week, prior to any intervention. * p < 0.05 when comparing with baseline assessment (t test with 95% confidence interval - Graphpad Prism software, USA, 2014). The results in FIGURE 32 indicate that the use of bioceramic shirts in combination with Pilates sessions statistically increased flexibility strength and grip strength.
[0374] Figures 33 and 34 are graphs illustrating the effect of the far infrared emitting bioceramic garment on the stabilometry of pilates practitioners. FIGURE 33 is a graph illustrating the effect of the far infrared emitting bioceramic garment on the (lateral) stabilometry of Pilates practitioners: laterolateral length (Table A), laterolateral distance (Table B), and velocity laterolateral (Table C). FIGURE 34 is a graph illustrating the effect of the far infrared emitting bioceramic garment on the (laterolateral) stabilometry of Pilates practitioners: lateroposterior length (Table A), anteroposterior distance (Table B) and anteroposterior velocity (Table C). * p < 0.05 indicates a statistically significant difference between groups. Baseline assessments were performed once a week, prior to any intervention. (paired t-test with 95% confidence interval - Graphpad Prism software, USA, 2014). The results shown in FIGURES 33 and 34 indicate that the use of bioceramic shirts together with the Pilates sessions statistically reduced the anteroposterior sway - total length, distance from the center and speed, while the use of placebo shirts affected it statistically (to a lesser degree ) the total length and distance from the center.
[0375] Heart rate variability (HRV): heart rate was assessed with the Nerve-Express unit (Valley Stream, NY, USA). A baseline assessment was performed before the start of testing and after eight weeks. Figure 35 illustrates the effect of the far infrared emitting bioceramic garment on the heart rate variability (HRV) of Pilates practitioners. Heart rate variability was assessed with the Nerve-Express unit (Valley Stream, NY, USA). The results in FIGURE 35 indicate that the use of far infrared emitting bioceramic jackets increased rMSNN and HF (high frequency energy) as well as decreased LF (low frequency energy). The combination of these results indicates an overall increase in parasympathetic autonomic nervous system activity and a decrease in the sympathetic branch (in this case, an increase in parasympathetic activity and a decrease in sympathetic activity indicate a more beneficial outcome). The RMSNN (the square root of the mean square deviations referring to the mean between adjacent NN intervals): commonly used as an index of cardiac control mediated by the vagus nerve, which captures respiratory sinus arrhythmia (RSA), the frequent changes in heart rhythm that occur in response to breathing. The RMSNN is an accepted measure of parasympathetic activity and correlates with the HF of frequency domain analysis. High frequency energy is a marker of parasympathetic activity. Low frequency energy is a marker of sympathetic and parasympathetic activity.
[0376] Sleep Quality: Sleep quality was assessed with the Pittsburgh Sleep Quality Questionnaire. A baseline assessment was performed before the start of testing and after eight weeks. FIGURES 36 and 37 illustrate the results of the Pittsburgh Sleep Quality Questionnaire. * p < 0.05 when comparing with baseline assessment (t-test paired with 95% confidence interval - Graphpad Prism software, USA, 2014). Several parameters were assessed, including daytime dysfunction (FIGURE 36, Table A), sleep quality (FIGURE 36, Table B), sleep efficiency (FIGURE 36, Table C), sleep disturbance (FIGURE 37, Table B) and the PQSI (FIGURE 37, Table C).
[0377] Results: The results presented in Figure 4 indicate that the use of far infrared emitting bioceramic shirts decreased the following indexes (a lower index indicates a more beneficial result): sleep duration: minimum score = 0 (better); maximum score = 3 (worst); sleep disturbance: minimum score = 0 (best); maximum score = 3 (worst); overall sleep quality: minimum score = 0 (best); maximum score = 3 (worst); and the Pittsburgh Sleep Quality Questionnaire: minimum score = 0 (best); maximum score = 21 (worst).
[0378] Conclusion: The use of far infrared radiation shirts during sleep increased sleep duration and efficiency, increased parasympathetic nervous system activity and also decreased sympathetic activity, which can be associated with more relaxed sleep and of better quality. Our studies have shown that the far infrared radiation (FIR) produced by Bioceramics promotes microcirculation (A), induces a reduction in muscle fatigue (B), reduces the effects of stress (C) and promotes analgesia and a reduction in conditions of inflammation (D); it is possible that the combination of these effects causes more relaxing and effective sleep. EXAMPLE 37: Effect of far infrared emitting bioceramic garment on weight loss, changes in body size and cellulite reduction.
[0379] Objectives: to investigate the effect of shorts comprising bioceramics on weight loss, changes in body measurements and cellulite reduction.
[0380] Study type: randomized, double-blind, placebo-controlled study Women randomly assigned to an experimental group (cFIR group, participants are asked to wear shorts impregnated with FIR-emitting ceramic material); and a control group (control group, participants are asked to wear shorts that are impregnated with a fake ceramic material, ie a ceramic material that does not provide far infrared energy). Randomization numbers were optionally generated from a randomization site (randomization.com).
[0381] Materials and methods: 30 healthy adult women with moderate to severe cellulite (cellulite score of at least II of IV), as assessed by a medical investigator, are randomized to either the experimental group or the control group (15 participants each group). Participants are blinded to the group they were assigned to. Participants wear the shorts daily for at least 6 hours a day for a period of six weeks.
[0382] Exclusion criteria include: • participants who received treatment for cellulite reduction in the thighs within one month of the study start time; • participants with a history of deep vein thrombosis within the past two years; • participants with a history of congestive heart failure; • participants diagnosed with arterial occlusive disease of the legs; within two weeks of the study period;
[0383] Parameters to be evaluated: The initial grade ie baseline, weight, cellulite and body measurements are taken for each participant prior to the start of the study. Follow-up measurements are taken approximately every two weeks from the start day of the study. The specific parameters being evaluated include: • weight or body mass index (BMI: weight in kilograms divided by height in meters squared). • thigh circumference. Measuring the circumference of the thigh at defined points with a flexible ruler can provide an indirect measure of localized fat and possibly relates to cellulite. Thigh circumference measurements will be taken on both legs 18 cm and 26 cm from the upper pole of the patella to the upper and lower thigh, respectively, using a flexible measuring ruler.• Cellulite observation. Direct or photographic visualization of skin irregularities, such as puckering, wavy, and nodules, is used to assess cellulite levels. High-quality color digital photographs are taken of the posterior and lateral thighs by an investigator at the following angles: (a) 90° from the right thigh (b) 45° from the right thigh (c) 180° from the right thigh (d) 90° on both thighs (e) 90° from the left thigh (f) 45° from the left thigh (g) 180° from the left thigh
[0384] Photographs are reviewed by five credentialed blind and independent dermatologists.• Skin elasticity. Measuring skin tension with a suction elastomer can provide an estimate of dermis resistance, a function of connective tissue helping to measure the amount of cellulite present.• Electrical conductivity of the skin. Electrical conductivity is used to measure tissue resistance to electron flow and to determine specific percentages of body composition (lean mass, fat mass, water).EXAMPLE 38: Effect of far infrared emitting bioceramic garment on tissue muscle recovery and delayed-onset muscle pain.
[0385] Objectives: to investigate the effect of bioceramic (short) underwear on muscle recovery after the protocol of muscle damage (strength), delayed onset muscle pain, blood levels of CK (creatine phosphokinase) and LDH (lactate dehydrogenase), blood levels of inflammatory and anti-inflammatory cytokines (TNF-α, IL-6, IL-1 β, IL-10 and IL-4) and levels of oxidative stress, as well as the activity of antioxidative enzymes ( TBARS carbonyls, SOD and catalase).
[0386] Study type: double-blind, placebo-controlled.
[0387] Intervention: subjects are randomly divided into 2 groups (placebo and bioceramics). Individuals in the placebo group use fake backgrounds (without bioceramics) while participants in the bioceramics group use backgrounds comprising bioceramics emitting far infrared radiation. Individuals in both groups use the intervention for a period of two hours immediately after starting the harm protocol (day 0). Subjects also wear underwear for additional two-hour periods, beginning on day 1 (24 hours after the start of the muscle damage protocol), day 2 (48 hours after the start of the muscle damage protocol), and day 3 ( 72 hours after starting the muscle damage protocol).
[0388] Assessments: a) Muscle recovery after muscle damage protocol: quadriceps strength is assessed with isokinetic equipment (De Queen, AR, USA). A baseline assessment is performed before the start of testing, immediately after the muscle damage protocol, and on days 1, 2, and 3 (after wearing the underwear).b) Delayed onset muscle pain is calculated with a visual analogue scale for the pain questionnaire (VAS). A baseline assessment is performed before the start of testing, immediately after the muscle damage protocol, and on days 1, 2, and 3 (after wearing the underwear).c) Blood CK (creatine phosphokinase) levels and LDH (lactate dehydrogenase), inflammatory and anti-inflammatory cytokines (TNF-α, IL-6, IL-1 β, IL-10 and IL-4), oxidative stress markers and antioxidative enzyme activity (TBARS carbonyls, SOD and catalase) are measured with biochemical analysis (ELISA). A baseline assessment is performed before the start of testing, immediately after the muscle damage protocol, and on days 1, 2, and 3 (after wearing the underwear).
[0389] Population and sample size: 30 participants: 15 individuals in each group. Uniform distribution between sexes/ages.EXAMPLE 39: Evaluation of biomodulation induced by the use of infrared radiation emitting ceramic shirts in patients with chronic obstructive pulmonary disease (COPD).
[0390] Objectives: This study evaluated the biomodulatory effects induced by the use of cFIR-impregnated shirts in patients with chronic obstructive pulmonary disease (COPD). COPD is defined as a chronic and progressive decrease in airflow secondary to an abnormal inflammatory response of the lungs. One of the characteristics of COPD is the reduction in muscle strength and aerobic capacity, which leads to loss of functionality and exercise intolerance, negatively impacting the patient's quality of life.
[0391] Inclusion criteria: Individuals diagnosed with COPD of both sexes were recruited according to the following criteria: clinical diagnosis of COPD and age (subjects were over 40 years of age).
[0392] Exclusion criteria: present disabling comorbidity and/or COPD exacerbations in the past 6 months.
[0393] For the treatment, T-shirts impregnated with a BioPower® brand bioceramic were used. Participants wore the shirts at night (6 to 8 hours) for 3 consecutive weeks. Assessments were performed before and after treatment. To classify each patient's clinical functional status, the modified medical research board dyspnea scale (mMRC) was used. To assess functional capacity, the London chest activity or the daily living scale (LCADL) and the six-minute walk test (6MWT) were performed. Autonomic nervous system activity was assessed by analyzing heart rate variability. 13 patients were recruited and there were 3 dropouts. Thus, the sample consisted of 10 individuals with COPD, with a mean age of 63.70 years, mean BMI of 26.19 kg/m2, and a smoking history of 24.41 years/pack. 40% of the sample were women and 60% were men.
[0394] Analysis of the LCADL questionnaire indicated that patients experienced a statistically significant improvement (p < 0.01) compared to their pretreatments (FIGURE 38). In the pre-treatment analyses, patients had a mean proportion of the total score equal to 42.88% and 40.36% in the post-treatment assessment.
[0395] In the 6MWT, using the BMI reference in equation 1, patients showed an increase of 5.37% of the predicted distance. FIGURE 39 illustrates the results of the 6MWT (performance-based functional exercise capacity test) with equation 1 (TABLE A), equation 2 (TABLE B) and the distance walked before and after treatment (TABLE C). The columns represent the mean values of 10 patients and the vertical lines correspond to the standard error of the means (SEM). ** P < 0.01 when comparing conditions before and after treatment (paired t-test). These data were corroborated with the analysis of equation 2 (using the ΔHR in the reference equation), in which there was an increase of 8.32% of the predicted distance. Furthermore, the results showed an increase of 36 meters compared to the pre-treatment assessment.
[0396] FIGURE 40 illustrates the results of heart rate variance (frequency domain) of COPD patients evaluated before and after treatment. (FRAME A) Low frequency (ms2), (FRAME B) low frequency (nu), (FRAME C) high frequency (ms2), (FRAME D) high frequency (nu). The columns represent the mean values of 10 patients and the vertical lines correspond to the standard error of the means (SEM). ** P < 0.01, when comparing the pre- and post-treatment condition (paired t-test).
[0397] FIGURE 41 illustrates the results of heart rate variance (time domain) of patients with COPD evaluated before and after treatment. (TABLE A) RR intervals (TABLE B) HR, SDNN component of the intervals (TABLE C), RMSNN (TABLE D). The columns represent the mean values of 10 patients and the vertical lines correspond to the standard error of the means (SEM). ** P < 0.01, when comparing the pre- and post-treatment condition (paired t-test).
[0398] Heart rate variability analyzes showed a reduction in low-frequency parameters, indicating reduced sympathetic nervous system activity. Based on these data, infrared radiation treatment through cFIR-impregnated shirts increased performance-based functional exercise capacity, reduced daily limitations, and reduced sympathetic nervous system activity in COPD patients. EXAMPLE 40: Evaluation of the Effect of Far Infrared Radiation Emitting Ceramic Shirts on Oxygen Consumption, Heart Rate and Sleep Quality: Randomized, Double-Blind, Placebo-Controlled Study with Young Baseball Players.
[0399] Objectives: This study investigated the effect of far infrared emitting ceramic shirts on oxygen consumption, heart rate and sleep quality.
[0400] Study design: double-blind placebo-controlled trial.
[0401] Intervention: Participants were randomly divided into 2 groups (placebo and biopower). The Biopower group wore a Biopower far infrared radiation emitting ceramic shirt (with bioceramics) while the placebo group members wore a negative control shirt (without bioceramics) for 6 weeks every night during sleep (6 to 8 hours) .
[0402] Assessments: a) initial VO2 consumption; b) maximum oxygen consumption (VO2Max); c) aerobic threshold (AeT); d) anaerobic threshold (AnT); e) heart rate (initial, in VO2Max, AeT and AnT); and f) sleep quality. Oxygen consumption and heart rate assessments were performed with the CardioCoach (VO2 assessment device - KORR Medical Technologies, Salt Lake City, UT, USA). Sleep quality was assessed with the Pittsburgh Sleep Quality Questionnaire. All participants were evaluated before the start of testing (baseline) and after 6 weeks.
[0403] Population and sample size: 30 participants: 15 individuals in a control group (fake shirts) and 15 individuals in an experimental group (bioceramic shirts). All participants were healthy male baseball players.
[0404] FIGURE 42 illustrates the results of the initial VO2 consumption of young baseball players: TABLE A illustrates the initial VO2 consumption. CHART B illustrates the percentage of participants with the highest initial VO2. CHART C illustrates the initial heart rate and CHART D illustrates the percentage of participants with a lower initial heart rate. Each column represents the mean of 12 to 15 participants, and the vertical lines indicate the standard error of the means. NS means not statistically significant (T test with 95% confidence interval - Graphpad Prism software, USA, 2014). The results presented in FIGURE 42, in CHART A, suggest that the use of bioceramic jackets increased the initial VO2 in a non-statistically significant way.
[0405] FIGURE 43 illustrates the results of VO2Max consumption of young baseball players: CHART A illustrates VO2Max and CHART B illustrates the percentage of participants with higher VO2Max. CHART C illustrates the heart rate of individuals in VO2Max and CHART D illustrates the percentage of participants with low heart rate in VO2Max. Each column represents the mean of 12 to 15 participants, and the vertical lines indicate the standard error of the means. NS means not statistically significant. *p < 0.05 when comparing with baseline assessment (t test with 95% confidence interval - Graphpad Prism software, USA, 2014). CHART C of FIGURE 43 suggests that the use of bioceramic liners decreased the heart rate of participants in VO2Max. In addition, a higher percentage of individuals in the group wearing bioceramic shirts had higher VO2Max and lower heart rate than the placebo group (CHARTS B to D) when compared to baseline. Results were measured after 6 weeks for each group.
[0406] FIGURE 44 illustrates the results of the aerobic threshold of young baseball players: CHART A illustrates the aerobic threshold (AeT) and CHART B illustrates the percentage of participants with higher AeT. CHART C illustrates heart rate in AeT and CHART D illustrates the percentage of participants with lower heart rate in AeT. Each column represents the mean of 12 to 15 participants, and the vertical lines indicate the standard error of the means. NS means not statistically significant. *p < 0.05 when comparing with baseline assessment (t test with 95% confidence interval - Graphpad Prism software, USA, 2014). The results shown in FIGURE 44, in CHART C, suggest that the use of bioceramic jackets decreased the heart rate of individuals in the AeT. Furthermore, a greater percentage of individuals in the group wearing the bioceramic shirts had higher AeT and lower heart rate than the placebo group (CHARTS B to D) compared to baseline. Results were measured after 6 weeks for each group.
[0407] FIGURE 45 illustrates the results of the anaerobic threshold of young baseball players: CHART A illustrates the anaerobic threshold (AeT) and CHART A illustrates the percentage of participants with higher AnT. CHART C illustrates heart rate in Ant and CHART D illustrates the percentage of participants with low heart rate in Ant. Each column represents the mean of 12 to 15 participants, and the vertical lines indicate the standard error of the means. NS means not statistically significant. *p < 0.05 when comparing with baseline assessment (t test with 95% confidence interval - Graphpad Prism software, USA, 2014). The results shown in FIGURE 44, in CHART C, suggest that the use of bioceramic liners decreased the heart rate of participants in AnT. In addition, a greater percentage of participants in the BioPower group had higher AeT and lower heart rate than the placebo group (TABLES B to D) compared to baseline. Results were measured after 6 weeks for each group.
[0408] FIGURE 46 illustrates the results of heart rate recovery 1 minute after the assessment of young baseball players: CHART A illustrates heart rate recovery 1 minute after the assessment and CHART B illustrates the percentage of participants with higher percentage of recovery, CHART C illustrates heart rate recovery 2 minutes after assessment and CHART D illustrates the percentage of participants with the highest percentage of recovery. Each column represents the mean of 12 to 15 participants, and the vertical lines indicate the standard error of the means. NS means not statistically significant (T test with 95% confidence interval - Graphpad Prism software, USA, 2014).
[0409] FIGURES 47A and 47B illustrate the results of the Pittsburgh Sleep Quality Questionnaire. Each column represents the mean of 12 to 15 participants, and the vertical lines indicate the standard error of the means. *p < 0.05 when comparing with baseline assessment (t test with 95% confidence interval - Graphpad Prism software, USA, 2014). The overall results shown in FIGURES 47A and 47B suggest that the use of BioPower far infrared radiation emitting ceramic jackets statistically reduced the following rates (a lower rate is indicative of a better result). FIGURE 47B, CHART AND sleep latency: minimum score = 0 (best); maximum score = 3 (worst); and FIGURE 47B, CHART F The Pittsburgh Sleep Quality Questionnaire: minimum score = 0 (best); maximum score = 21 (worst). The differences between the bioceramics and the control groups for FIGURE 47A, TABLES A to C (sleep duration, sleep disturbance, day dysfunction) and FIGURE 47B, TABLE A (day dysfunction due to drowsiness) were not statistically significant .
[0410] Although preferred embodiments of the present invention have been demonstrated and described in this document, it will be obvious to persons skilled in the art that such embodiments are provided by way of example only. Countless variations, alterations and substitutions will now occur to persons skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein can be used in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents are covered by them.

权利要求:
Claims (14)
[0001]
1. Use of a bioceramic composition characterized in that it is for preparing an article of clothing to increase muscle endurance, muscle recovery or sleep quality in an individual, comprising placing the article of clothing comprising the bioceramic composition in contact with the individual, where, when heated or exposed to heat, the bioceramic composition provides far infrared thermal radiation and a biomodulating or physiological effect to the individual that increases muscle endurance, muscle recovery, or sleep quality in an individual of a non-invasive form, wherein the bioceramic composition comprises: a. about 40% by weight to about 60% by weight kaolinite (Al2Si2O5(OH)4); b. about 5% by weight to about 15% by weight tourmaline (NaFe2+3Al6Si6O18(BO3)3(OH)3OH); c. about 15% by weight to about 25% by weight aluminum oxide (Al2O3); ed. about 1 wt% to about 20 wt% silicon dioxide (SiO 2 ).
[0002]
2. Use according to claim 1, characterized in that the reflectance of the bioceramic composition at an ambient temperature of 25°C is at least 80% in an infrared range between about 7 micrometers and about 12 micrometers.
[0003]
3. Use according to any one of claims 1 to 2, characterized in that, when exposed to heat, the article of clothing comprising the bioceramic composition provides at least 1.5 joule/cm2 of far infrared energy to an individual.
[0004]
4. Use according to any one of claims 1 to 3, characterized in that, when exposed to heat, the article of clothing comprising the bioceramic composition provides a maximum of 45 joules/cm2 of far infrared radiation for a individual.
[0005]
5. Use, according to any one of claims 1 to 4, characterized by the fact that the bioceramic composition has a statistically significant change of at least 5% in muscle strength, muscle recovery or sleep quality in the individual.
[0006]
6. Use according to any one of claims 1 to 5, characterized in that the bioceramic composition is applied to more than 5% of the surface area of the garment.
[0007]
7. Use according to any one of claims 1 to 6, characterized in that the bioceramic composition provides a biomodulatory or physiological effect to the individual in less than 1 week of using the article of clothing.
[0008]
8. Use according to any one of claims 1 to 7, characterized in that the bioceramic composition is applied as a coating to an internal or external surface of an article.
[0009]
9. Use according to any one of claims 1 to 8, characterized in that the article of clothing is selected from the group consisting of a shirt, a jacket, shorts or trousers, wrist band, a padding, a knee brace , an anklet, an elbow pad, a body support, a wristband, a sleeve or a plaster.
[0010]
10. Use according to any one of claims 1 to 9, characterized in that the article of clothing is selected from the group consisting of sheets, pillows, pillow covers, duvet covers, duvet covers, mattress covers, protectors for mattresses and the like.
[0011]
11. Use according to any one of claims 1 to 10, characterized in that the article of clothing further comprises a material selected from the group consisting of wool, silk, cotton, canvas, jute, glass, nylon, polyester, acrylic, spandex, polychloroprene, laminated fabrics containing expanded polytetrafluoroethylene and combinations thereof.
[0012]
12. Use according to any one of claims 1 to 11, characterized in that the article of clothing further comprises a material selected from the group consisting of nylon, a polyvinyl chloride elastomer, a polystyrene elastomer, an elastomer of polyethylene, a polypropylene elastomer, a polyvinyl butyral elastomer, silicone, a thermoplastic elastomer, a polygel and combinations thereof.
[0013]
13. Use according to any one of claims 1 to 12, characterized in that the purity of tourmaline or kaolinite is greater than 95% pure.
[0014]
14. Use according to any one of claims 1 to 13, characterized in that the bioceramic composition comprises yet another oxide selected from titanium dioxide (TiO2) or magnesium oxide (MgO).

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JP2020143420A|2020-09-10|

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AU2015256338A1|2016-11-10|

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US20180055933A1|2018-03-01|

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US20160136386A1|2016-05-19|

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PE20170278A1|2017-04-05|

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EP3140004A4|2018-01-10|

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JP2017525400A|2017-09-07|

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US20160136452A1|2016-05-19|

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BR112016026001A2|2017-08-15|

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KR20170003607A|2017-01-09|

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CA2946898A1|2015-11-12|

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EP3140004A1|2017-03-15|

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EA201692098A1|2017-05-31|

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法律状态:
2020-07-28| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-06-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-08-03| B09W| Correction of the decision to grant [chapter 9.1.4 patent gazette]|Free format text: RETIFIQUE-SE POR INCORRECAO NO QUADRO 1 |

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2021-08-17| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 01/05/2015, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201461988837P| true| 2014-05-05|2014-05-05|

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US61/988,837|2014-05-05|

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US201462018085P| true| 2014-06-27|2014-06-27|

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US62/018,085|2014-06-27|

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US201462062686P| true| 2014-10-10|2014-10-10|

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US62/062,686|2014-10-10|

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US201462064939P| true| 2014-10-16|2014-10-16|

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US62/064,939|2014-10-16|

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US201562115567P| true| 2015-02-12|2015-02-12|

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US62/115,567|2015-02-12|

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PCT/US2015/028910|WO2015171467A1|2014-05-05|2015-05-01|Bioceramic compositions and biomodulatory uses thereof|

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