EA041903B1 - BIOCERAMIC COMPOSITIONS AND THEIR APPLICATION FOR BIOMODULATION - Google Patents

Description

The wavelength of the infrared range varies from 0.7 to 1000 microns and is immediately beyond the boundaries of the visible light of the electromagnetic spectrum. Infrared radiation has strong physical properties and great thermal activity.

The essence of the invention

The natural resonant frequency range of water and living organisms, including humans, is within the infrared range. For example, the wavelength range of 6-18 microns is favorable for the human body due to its activating and tonic effect on the body. Indeed, human skin emits an infrared wave of 9.36 microns, which is very close to the resonant frequency of the water molecule - and rightly so, since our bodies are about 70% water. Infrared waves are considered a safe and useful source of energy for humans. The authors of the present invention have identified the useful properties of bioceramic compositions according to the invention and applications, as described in this document.

As described herein, bioceramics include ceramics that emit infrared waves beneficial to living organisms. The object of the invention described in this document uses the beneficial effects of infrared radiation. The methods, articles, systems, and compositions described herein use a unique composition of bioceramic materials, which are ultrafine mineral particles that, when heated by a living organism, such as the human body, emit radiation energy in the far infrared region. The bioceramic materials described herein are refractory polycrystalline compounds which, due to their inertness in aqueous conditions, are highly biocompatible and safe for human interaction and application to humans. The inventors have discovered many biomodulatory or physiological uses for these bioceramic formulations, including, but not limited to, regulation of cellular metabolism, induction of analgesia, muscle relaxation, and modulation of inflammation and oxidative stress.

In accordance with 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 motion of charged particles in matter. Thus, when the bioceramic materials, articles and compositions described herein and the human body are in contact, there is an exchange of thermal radiation, in particular far infrared radiation. Due to the specific properties of the minerals and oxides contained in the subject matter described here, ie. highly refractory minerals, this radiation is amplified in the far infrared spectrum, which has numerous biomodulatory or physiological effects. The inventors have unexpectedly discovered numerous advantages of using the bioceramic materials described herein, which complement or serve as the basis for a therapeutic approach for living organisms.

The subject matter of the invention described herein provides a non-invasive, safe, convenient and effective method for delivering the benefits of far infrared radiation therapy to a subject. For example, in some embodiments, the patient carries, wears, and/or uses the bioceramic compositions, for example, when applied to a finished product, such as a T-shirt, at home and/or during daily activities to enhance the beneficial effects of the treatment that the patient may receive in the clinic, or to improve the patient's condition during or after exercise.

A feature of the subject matter described herein, including articles, compositions, methods, devices, and systems, is a composition that contains a bioceramic, wherein when heated or exposed to heat, such as that of the human body, the bioceramic provides a biomodulatory physiological effect when the article is applied to subject. In some embodiments, the product is a garment such as a T-shirt.

Another distinguishing feature of the subject matter of the invention described here is the bioceramic composition. For example, in one embodiment, the composition contains:

(a) from about 20 to about 80 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ );

(b) from about 1 to about 30 wt.% tourmaline;

(c) from about 1 to about 40 wt.% alumina (Al ₂ O ₃ );

(d) from about 1 to about 40 wt.% silicon dioxide (SiO ₂ );

- 1 041903 (e) from about 1 to about 20 wt.% zirconium oxide (ZrO ₂ );

the quantities are presented based on the total weight of the bioceramic composition.

In another embodiment, the composition contains:

(a) about 40 to 60 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ );

(b) about 5 to 15% tourmaline by weight;

(c) about 15 to 25 wt.% alumina (Al ₂ O ₃ );

(d) about 10 to 20 wt.% silicon dioxide (SiO ₂ );

(e) about 1 to 20 wt.% zirconium oxide (ZrO ₂ );

the quantities are presented based on the total weight of the bioceramic composition.

In yet another embodiment, a bioceramic composition is provided comprising:

(a) about 50 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ );

(b) about 10 wt.% tourmaline;

(c) about 18 wt.% alumina (Al ₂ O ₃ );

(d) about 14 wt.% silicon dioxide (SiO ₂ );

(e) about 8 wt.% zirconium oxide (ZrO ₂ );

the quantities are presented based on the total weight of the bioceramic composition.

In some of these embodiments, the compositions contain tourmaline and said tourmaline is NaFe ²⁺ ₃ Al ₆ Si ₆ O ₁₈ (BO ₃ ) ₃ (OH) ₃ OH.

An additional feature of the subject matter described herein is the provision of a biomodulatory or physiological effect that includes modulation of pain, increased muscle endurance, modulation of the cardiorespiratory system, modulation of cellular metabolism, analgesia, antioxidative effect, antifibromyalgic effect, reduction of inflammation, reduction of oxidative stress, modulation of levels cytokines, modulating blood circulation, reducing cold intolerance, ameliorating a symptom of arthritis or vascular disease, increasing skin perfusion, decreasing heart rate, lowering blood pressure, an aesthetic effect such as body parameters, weight loss, or reduction in cellulite in a subject.

Another feature of the subject matter of the invention described herein is a non-invasive method of providing a biomodulatory or physiological effect to a subject or subject, which includes bringing an article containing bioceramic into contact with the skin of the subject, wherein, when heated or exposed to heat, the bioceramic composition provides thermal radiation in the far infrared regions and a biomodulatory or physiological effect on the subject in a non-invasive manner.

Another distinguishing feature of the subject matter of the invention described here is a method for manufacturing an article, comprising the following steps:

(a) preparing the bioceramic solution;

(b) applying the solution to the article;

while the solution when applied to the product contains:

about 20 to 80 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ );

about 1 to 30 wt.% tourmaline;

about 1 to 40 wt.% alumina (Al ₂ O ₃ );

about 1 to 40 wt.% silicon dioxide (SiO ₂ );

about 1 to 20 wt.% zirconium oxide (ZrO ₂ ), while, in addition, the amounts are based on the total weight of the bioceramic composition.

An additional distinguishing feature of the subject matter of the invention described here is a method for manufacturing an article, including the steps:

(a) preparing the bioceramic solution;

(b) applying the solution to the article;

at the same time, when heated or exposed to heat, the bioceramic provides a biomodulating or physiological effect when the product is applied to the subject.

Brief description of the drawings

The novel features contained in the invention are set forth in detail in the appended claims. A better understanding of the features and advantages of the present invention may be obtained from the following detailed description containing illustrative embodiments of the present invention in which the principles of the invention are used, as well as from the accompanying drawings, which are contained in this document in the Examples section below.

In FIG. 1 is a non-limiting example of a T-shirt containing the bioceramic of the present invention.

In FIG. 2 is a non-limiting example of a T-shirt and pad containing the bioceramic of the present invention.

In FIG. 3 is a graph illustrating a non-limiting example of the effects of a bioceramic according to the present disclosure on flexibility.

In FIG. 4 is a graph illustrating a non-limiting example of the effects of bioceramics of the present disclosure on tidal volume.

In FIG. 5 is a graph illustrating a non-limiting example of the effects of the bioceramic of the present invention on maximum expiratory flow (PEF).

In FIG. 6 is a non-limiting example of the effects of the bioceramics of the present invention on muscle endurance.

In FIG. 7 is a non-limiting example of the effects of the bioceramic of the present invention on cardiorespiratory endurance.

In FIG. 8 is a non-limiting example of the effects of bioceramic paint on CFA-induced mechanical hypersensitivity.

In FIG. 9 is a non-limiting example of a bioceramic paint according to the present invention.

In FIG. 10 shows a non-limiting example of a pad containing a bioceramic according to the present invention.

In FIG. 11 is a non-limiting example of a bracelet containing a bioceramic according to the present invention.

In FIG. 12 is a graph illustrating a non-limiting example of a subjectively perceived reduction in overall pain levels of greater than 7.5% in human subjects treated with clothing according to the present invention.

In FIG. 13 is a graph illustrating a non-limiting example of a subjectively perceived improvement in overall levels of well-being of greater than 46% in human subjects treated with clothing according to the present invention.

In FIG. 14 is a graph illustrating a non-limiting example of a subjectively perceived reduction in overall levels of fatigue of greater than 25% in human subjects treated with clothing according to the present invention.

In FIG. 15 is a graph illustrating a non-limiting example of a subjectively perceived improvement in overall sleep quality of greater than 8.5% in human subjects treated with clothing according to the present invention.

In FIG. 16 is a graph illustrating a non-limiting example of a subjectively perceived improvement in overall performance levels of more than 7% in human subjects treated with clothing according to the present invention.

In FIG. 17 is a non-limiting example of the absolute value of the infrared radiation intensity of smooth tissue (not containing bioceramics).

In FIG. 18 is a non-limiting example of the absolute value of the infrared radiation intensity of a tissue containing 30% bioceramics according to the present invention.

In FIG. 19 is a non-limiting example of the absolute value of the infrared intensity of a tissue containing 50% bioceramics according to the present invention.

In FIG. 20 provides non-limiting example graphs that show that exposure to a pad containing increased concentrations of bioceramic and for longer periods of exposure (both embodiments of the present invention) produces longer lasting effects.

In FIG. 21 is a non-limiting graph illustrating the effect of adding a bioceramic according to the present disclosure to a water treatment in a hydroponic system.

In FIG. 22 is a non-limiting example of a graph illustrating the lower electrical conductivity of water treated with the bioceramic of the present invention on days 16 to 20 compared to the control group (water only).

In FIG. 23 are non-limiting examples of photographs showing the effect of the bioceramic of the present invention on the growth of organic crops.

In FIG. 24 is a graph illustrating a non-limiting example of the analgesic effect of a far-infrared bioceramic (cFIR) of the present invention compared to another formulation in a mouse model of CFA-induced mechanical hypersensitivity.

In FIG. 25 shows a non-limiting example of infrared transmission by various bioceramic compositions according to the present invention.

In FIG. 25A shows infrared transmission of the bioceramic compositions described herein containing 18% alumina, 14% silica, 50% kaolinite, 8% zirconia, and 10% tourmaline.

In FIG. 25B shows infrared transmission of the bioceramic compositions described herein containing 20% aluminium, 3% titanium, 11% magnesium oxide, 6% diiron trioxide (hematite), and 60% silicon.

In FIG. 26 is a graph illustrating the effect of bioceramic clothing emitting

- 3 041903 far infrared radiation, on heart rate and performance based on functional exercise capacity of human subjects afflicted with fibromyalgia who followed a hydrotherapy regimen.

In FIG. 27 shows that hydrotherapy in combination with the use of a control garment had no effect on the balance of the subjects, while the use of bioceramics emitting far infrared radiation statistically reduced latero-lateral vibrations.

In FIG. 28 is a graph illustrating the effects on overall pain perception in fibromyalgia human subjects treated with an infrared-emitting bioceramic bodyworn or dummy bodyworn.

In FIG. 29A is a graph illustrating the results of the Fibromyalgia Impact Questionnaire (FIQ) (panel A), the McGill pain questionnaire (panel B), and the McGill descriptors index (panel C).

In FIG. 30 is a block diagram of a study according to the invention.

In FIG. 31 is a graph illustrating the effect of far infrared emitting bioceramic clothing on postural control.

In FIG. 32 is a graph illustrating the effect of far-infrared bioceramic clothing on flexibility and grip strength in Pilates practitioners.

In FIG. 33 is a graph illustrating the effect of far-infrared-emitting bioceramic clothing on stabilometry (lateral-lateral) in Pilates practitioners.

In FIG. 34 is a graph illustrating the effect of far-infrared-emitting bioceramic clothing on stabilometry (anterior-posterior) in Pilates practitioners.

In FIG. 35 shows the effect of far-infrared bioceramic clothing on heart rate variability (HRV) in Pilates practitioners.

In FIG. 36 shows the effects of far infrared bioceramic clothing on daytime dysfunction (panel A), sleep quality (panel B), and sleep efficiency (panel C).

In FIG. 37 shows the effects of far infrared bioceramic clothing on sleep duration (panel A), sleep disturbance (panel B), and PQSI (panel C).

In FIG. 38 shows the results of the London Chest Activity of Daily Living Questionnaire (LCADL) in subjects with chronic obstructive pulmonary disease (COPD).

In FIG. 39 shows the results of performing exercise capacity tests in subjects with chronic obstructive pulmonary disease (COPD).

In FIG. 40 shows the results of a heart rate variability (HRV) test (frequency domain method) in subjects affected by chronic obstructive pulmonary disease (COPD) before and after bioceramic treatment.

In FIG. 41 shows the results of a heart rate variability (HRV) test (time domain method) in subjects affected by chronic obstructive pulmonary disease (COPD) before and after bioceramic treatment.

In FIG. 42 shows the results of an initial VO ₂ oxygen consumption test in young baseball players training in bioceramic T-shirts or imitation T-shirts.

In FIG. 43 shows the results of the initial _VO2max test in young baseball players training in bioceramic or fake T-shirts.

In FIG. 44 shows the results of an aerobic threshold test in young baseball players training in bioceramic T-shirts or fake T-shirts.

In FIG. 45 shows the results of an anaerobic threshold test in young baseball players training in bioceramic T-shirts or fake T-shirts.

In FIG. 46 shows heart rate recovery in young baseball players training in bioceramic T-shirts or fake T-shirts.

In FIG. 47A shows the effects of far infrared clothing on sleep duration (panel A), sleep disturbance (panel B), and daytime dysfunction (panel C) in young baseball players.

In FIG. 47B shows the effects of far infrared clothing on daytime sleep dysfunction (panel A), sleep latency (panel B), and PQSI (panel C) in young baseball players.

- 4 041903

Detailed description of the invention

As used herein, singular grammatical forms include references to the plural unless the context clearly dictates otherwise. Unless otherwise indicated, all technical and scientific terms used herein have the same meanings that are commonly understood by a person skilled in the art. As used herein, the term containing means including, but not limited to.

Without being limited by any theory, the inventors of the present invention have found 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. Since a significant proportion of living organisms include water, the resonant frequency of the emission of water molecules from the bioceramics described here can activate water and affect living organisms, including humans, including the treatment of diseases and biological complications and pathways.

The bioceramic of the present invention radiates far infrared radiation energy towards or away from the subject's body. When the bioceramic radiates energy towards the subject's body, the bioceramic provides the cells with concentrated radiant energy by reflecting far infrared or body heat radiation energy into the subject's joints, muscles, and tissues of the subject. Far infrared radiation energy penetrates cells and provides biomodulatory or physiological effects such as anti-inflammatory, analgesic and other biomodulatory or physiological effects. When the bioceramic radiates energy away from the subject's body, the bioceramic prevents the far infrared radiation energy from penetrating through the subject's skin, thereby providing a cooling effect.

bioceramic compositions.

One aspect of the articles, compositions, methods, devices, and systems described herein is a bioceramic composition that, in certain applications, provides a biomodulatory or physiological effect. For example, in some embodiments, a bioceramic composition is provided that, when heated or exposed to heat, provides a biomodulatory or physiological effect when the article is applied to a subject.

In one embodiment, the bioceramic contains:

a) about 20 to 80 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ );

b) about 1 to 30% tourmaline by weight;

c) about 1 to 40 wt.% alumina (Al ₂ O ₃ );

d) about 1 to 40 wt.% silicon dioxide (SiO ₂ );

e) about 1 to 20 wt.% zirconium oxide (ZrO ₂ );

the quantities are presented based on the total weight of the bioceramic composition.

In further or additional embodiments, a bioceramic composition is provided that, when heated or exposed to heat, provides a biomodulatory or physiological effect when the article is applied to a subject, comprising:

a) about 40 to 60 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ );

b) about 5 to 15% tourmaline by weight;

c) about 15 to 25 wt.% alumina (Al ₂ O ₃ );

d) about 10 to 20 wt.% silicon dioxide (SiO ₂ );

e) about 1 to 20 wt.% zirconium oxide (ZrO ₂ );

the quantities are presented based on the total weight of the bioceramic composition.

In some embodiments, the implementation of the bioceramic composition contains kaolinite in an amount of about 45 to 55 wt.%. In further or additional embodiments, a bioceramic composition is provided that contains kaolinite in an amount of about 47 to 53% by weight. In further or additional embodiments, a bioceramic composition is provided that contains kaolinite in an amount of about 48 to 52% by weight.

In some embodiments, a bioceramic composition is provided that contains:

a) about 50 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ );

b) about 10 wt.% tourmaline;

c) about 18 wt.% alumina (Al ₂ O ₃ );

d) about 14 wt.% silicon dioxide (SiO ₂ );

e) about 8 wt.% zirconium oxide (ZrO ₂ ).

Another feature of the subject matter described herein are bioceramic compositions that include tourmaline. As used herein, the term tourmaline has a meaning known in the field of minerals and gems. For example, tourmaline is a group of isomorphic minerals with an identical crystal lattice. Each member of the tourmaline group has its own chemical formula due to slight differences in their elemental distribution. For example, in some embodiments, tourmaline has the following generic formula:

- 5 041903

X1Y3Al6(BO3)3Si6O18(OH)4, where X = Na and/or Ca;

Y = Mg, Li, Al and/or Fe ²⁺ , which is represented by the following formula:

(Na, Ca)(Mg, Li, Al, Fe^AWBOP^O^OH^.

In some embodiments, Al may 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, Fe ²⁺ h(Al, Mg, Cr)6(BO3)3Si6O18(OH)4.

In some embodiments, tourmaline is a bergerite that contains three O atoms and one F atom in place of the OH radical. The bergerite molecule also contains an Fe atom, which is in the 3+ oxidation state, and is denoted as follows:

(Na, Ca)(Mg, Li, Al, Fe ²⁺ ,Fe ³⁺ )3(Al, Mg, Cr)6(BO3hSi6O18(OH, O, F)4.

In other embodiments, the tourmaline is one or more of the following:

Schorl: NaFe ² AAIft(BO3) ₃ Si6Ois(OH) ₄ ;

Dravite: NaMg ₃ A16(BO ₃ )3Si6Oi8(OH) ₄ ;

Elbaite: Na(L1,A1) ₃ Alb(BO3)386O18(OH) ₄ ;

Liddicoatite: Ca(N, Al)3A1b(BO3)386O18(OH)4;

Uvit: Ca (M _& Re ² DzA15M _yo (BO3) z3! bO18 (OH) 4;

Bergerite: \аРс%А1b(BO3)^|D)-koOSCH

In one embodiment, a tourmaline-based bioceramic composition is provided that contains NaFe ²⁺ ₃ Al ₆ Si ₆ O ₁₈ (BO ₃ ) ₃ (OH) ₃ OH.

Another aspect of the articles, composite mixtures, methods, devices and systems described herein is a bioceramic composition consisting of micrometer-sized particles. For example, in some embodiments, a bioceramic composition is provided wherein the largest size of any bioceramic particle in the bioceramic is about 0.1 to 250 microns. In further or additional embodiments, a bioceramic composition is provided wherein the largest size of any particle in the bioceramic is about 0.5 to 25 microns. In some instances, the bioceramic particle may have a diameter or cross-sectional area of about 0.1 to 1 µm, about 0.1 to 10 µm, about 0.1 to 20 µm, about 0.1 to 30 µm, about 0.1 to 40 µm, about 0.1 to 50 µm, about 0.1 to 60 µm, about 0.1 to 70 µm, about 0.1 to 80 µm, about 0.1 to 90 µm, about 0.1 to 100 µm, or other desired size. In some cases, the inlet may have a transverse diameter of about 10 to 100 microns, about 10 to 200 microns, about 10 to 300 microns, about 10 to 400 microns, about 10 to 500 microns, or other desired size.

In further or additional embodiments, a bioceramic composition is provided that, when heated or exposed to heat, provides a biomodulatory or physiological effect when the article is applied to a human, wherein the bioceramic composition contains tourmaline, kaolinite, and at least one oxide. In some cases, the bioceramic of the present invention contains tourmaline, kaolinite, alumina and silica. In some cases, the bioceramic of the present invention contains tourmaline, kaolinite, alumina, silica, and one other oxide. In some cases, the other oxide is zirconium oxide. In some cases, the other oxide is titanium dioxide (TiO ₂ ). In some cases, the other oxide is magnesium oxide (MgO).

Kaolinite is a layered silicate mineral containing oxides. In some cases, kaolinite contains various oxides. In some cases, the bioceramic composition contains additional oxides that are not part of the kaolinite. In some embodiments, the bioceramic composition contains 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.

In some embodiments, the implementation of the oxide of the bioceramic composite mixture according to the present invention has different oxidation states. The oxide of the present invention has an oxidation state of +1, +2, +3, +4, +5, +6, +7 or +8. In some cases, the bioceramic composition according to the invention contains more than one oxide, with at least one oxide having a different oxidation state from the other oxide. For example, in some cases, the bioceramic composition according to the present invention contains alumina (Al2O3) with an oxidation state of +2 or +3, silicon dioxide (SiO ₂ ) with an oxidation state of +4, and zirconium oxide (ZrO ₂ ) with an oxidation state of +4.

Non-limiting examples of oxides with an oxidation state of +1 include copper(I) oxide (Cu ₂ O),

- 6 041903 dicarbon monoxide (C2O), dichlorine monoxide (Cl ₂ O), lithium oxide (Li2O), potassium oxide (K2O), rubidium oxide (Rb2O), silver oxide (Ag ₂ O), thallium(1) oxide (Tl ₂ O), sodium oxide (Na2O) or water (hydrogen oxide) (H2O).

Non-limiting examples of +2 oxides include alumina(II) oxide (AlO), barium oxide (BaO), beryllium oxide (BeO), cadmium oxide (CdO), calcium oxide (CaO), carbon monoxide (CO), chromium oxide (P) (CrO), cobalt(II) oxide (CoO), copper(II) oxide (CuO), iron(II) oxide (FeO), lead(II) oxide (PbO), magnesium oxide (MgO), oxide mercury(P) (HgO), nickel(P) oxide (MO), nitric oxide (NO), palladium(P) oxide (PdO), strontium oxide (SrO), sulfur monoxide (SO), disulfur dioxide (S2O2), tin(II) oxide (SnO), titanium(II) oxide (TiO), vanadium(II) oxide (VO), or zinc oxide (ZnO).

Non-limiting examples of +3 oxides include alumina (Al ₂ O ₃ ), antimony trioxide (Sb ₂ O ₃ ), arsenic trioxide (As ₂ O ₃ ), bismuth(III) oxide (Bi ₂ O ₃ ), boron trioxide (B ₂ O ₃ ), chromium(III) oxide (Cr ₂ O ₃ ), dinitrogen trioxide (N2O3), erbium(III) oxide (Er ₂ O ₃ ), gadolinium(III) oxide (Gd ₂ O ₃ ), oxide gallium (III) (Ga ₂ O ₃ ), holmium oxide (III) (Ho ₂ O ₃ ), indium oxide (III) (In ₂ O ₃ ), iron oxide (III) (Fe ₂ O ₃ ), lanthanum oxide ( La ₂ O ₃ ), lutetium oxide (III) (Lu ₂ O ₃ ), nickel oxide (III) (Ni ₂ O ₃ ), phosphorus trioxide (P ₄ O ₆ ), promethium oxide (III) (Pm ₂ O ₃ ) , rhodium oxide (Sh) (Rh ₂ O ₃ ), samarium oxide (Sh) (Sm ₂ O ₃ ), scandium oxide (Sc ₂ O ₃ ), terbium oxide (Sh) (Tb ₂ O ₃ ), thallium oxide (Sh ) (Tl ₂ O ₃ ), thulium oxide (Ш) (Tm ₂ O ₃ ), titanium oxide (Ш) (Ti ₂ O ₃ ), tungsten oxide (Ш) (W ₂ O ₃ ), vanadium oxide (Ш) ( V ₂ O ₃ ), ytterbium(III) oxide (Yb ₂ O ₃ ), yttrium(III) oxide (Y2O3).

Non-limiting examples of +4 oxides include carbon dioxide (CO2), carbon trioxide (CO3), cerium(IV) oxide (CeO ₂ ), chlorine dioxide (ClO ₂ ), chromium(IV) oxide (CrO ₂ ), dinitrogen tetroxide (N ₂ O ₄ ), germanium dioxide (GeO2), hafnium(IV) oxide (HfO ₂ ), lead dioxide (PbO ₂ ), manganese dioxide (MnO ₂ ), nitrogen dioxide (NO2), plutonium(IV) oxide (PuO ₂ ), rhodium(IV) oxide (RhO2), ruthenium(IV) oxide (RuO2), selenium dioxide (SeO ₂ ), silicon dioxide (SiO ₂ ), sulfur dioxide (SO2), tellurium dioxide (TeO ₂ ), thorium dioxide (ThO ₂ ), tin dioxide (SnO ₂ ), titanium dioxide (TiO ₂ ), tungsten(IV) oxide (WO2), uranium dioxide (UO2), vanadium(IV) oxide (VO2) or zirconia (ZrO ₂ ).

Non-limiting examples of oxides with an oxidation state of +5 include antimony pentoxide (Sb ₂ O ₅ ), arsenic pentoxide (As ₂ O ₅ ), dinitrogen pentoxide (N ₂ O ₅ ), niobium pentoxide (Nb ₂ O ₅ ), phosphorus pentoxide (P ₂ O ₅ ), tantalum pentoxide (Ta ₂ O ₅ ) or vanadium(V) oxide (V ₂ O ₅ ).

Non-limiting examples of oxides with an oxidation state of +6 include chromium trioxide (CrO ₃ ), molybdenum trioxide (MoO ₃ ), rhenium trioxide (ReO ₃ ), selenium trioxide (SeO ₃ ), sulfur trioxide (SO ₃ ), tellurium trioxide (TeO ₃ ) , tungsten trioxide (WO3), uranium trioxide (UO3) or xenon trioxide (XeO ₃ ).

Non-limiting examples of oxides with an oxidation state of +7 include dichlor heptoxide (Cl ₂ O ₇ ), manganese heptoxide (Mn ₂ O ₇ ), rhenium(VII) oxide (Re ₂ O ₇ ), or technetium(VII) oxide (Tc ₂ O ₇ ) .

Non-limiting examples of oxides with an oxidation state of +8 include osmium tetroxide (OsO ₄ ), ruthenium tetroxide (RuO 4 ), xenon tetroxide (XeO 4 ), iridium tetroxide (IrO 4 ), or hassium tetroxide (HsO 4 ).

Non-limiting examples of oxides with various oxidation states include antimony tetroxide (Sb ₂ O ₄ ), cobalt(P, III) oxide (CO ₃ O ₄ ), iron(P, III) oxide (Fe ₃ O ₄ ), lead oxide (P, IV) (Pb ₃ O ₄ ), manganese oxide (P, III) (Mn ₃ O ₄ ) or silver oxide (I, III) (AgO).

In further or additional embodiments, the implementation of the bioceramic composition according to the present invention, in addition, contains a metal. The metal may 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, group 14, and group 15 metals. Periodic table. Non-limiting examples of the metal 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.

The content of minerals and oxides in the bioceramic composition can be varied depending on a number of variables, including, for example, the amount of thermal radiation, in particular radiation in the far infrared spectrum, to be emitted, the disease or condition to be treated, the route of administration, the requirements of the particular subject, the severity of the disease or condition being treated, or the physician's judgment.

physical properties.

Tourmaline and kaolinate have different granulometric, mineralogical, chemical and physical properties depending, for example, on whether the minerals are extracted from a particular geographic area or chemically synthesized. For example, in many parts of the world, kaolinite has a pink-orange-red color that is related to the amount of impurity(s). Often the impurity(s) contain iron oxide. In some embodiments, the implementation of the kaolinite according to the present description has a high level of purity and is characterized by a pure white color.

In some embodiments, the purity of tourmaline or kaolinate is related to the amount

- 7 041903 infrared energy emitted by the bioceramic composition. In some cases, the kaolinite or tourmaline of the bioceramic composition according to the invention has a purity greater than 99, greater than 98, greater than 97, greater than 96, greater than 95, greater than 94, greater than 93, greater than 92, greater than 91, greater than 90, more than 89, more than 88, more than 87, more than 86, more than 85, more than 80, more than 75, more than 70, more than 65, more than 60 and more than 55%.

In some embodiments, the graininess of the kaolinite or tourmaline is related to the amount of infrared energy emitted by the bioceramic composition. For example, a bioceramic composition containing a coarse sized mineral reflects an amount of infrared energy that is different from the amount of infrared energy reflected by a bioceramic composition containing smaller minerals. In some embodiments, the grain size of the bioceramic composition varies from about 100 nm to 0.1 µm, about 100 nm to 1 µm, about 100 nm to 10 µm, about 100 nm to 25 µm, about 100 nm to 50 µm, about 100 nm to 75 µm, about 100 nm to 100 µm, about 100 nm to 125 µm, about 100 nm to 150 µm, about 100 nm to 175 µm, about 100 nm to 300 µm, about 100 nm to 225 µm or about 100 nm to 250 µm.

In some embodiments, the grain size of the bioceramic composition varies from about 0.5 to 1 µm, about 0.5 to 10 µm, about 0.5 to 25 µm, about 0.5 to 50 µm, about 0.5 to 75 µm, about 0.5 to 100 µm, about 0.5 to 125 µm, about 0.5 to 150 µm, about 0.5 to 175 µm, about 0.5 to 200 µm, about 0.5 to 225 µm or about 0.5 to 250 µm.

Emission, transmission and reflection of radiation in the far infrared region

Yet another aspect of the articles, compositions, methods, devices, and systems described herein is a bioceramic composition that emits, transmits, and/or reflects infrared radiation when heated or exposed to heat. In some embodiments, bioceramics are provided. In some embodiments, a bioceramic is provided that absorbs, stores, and/or reflects thermal energy, such as far infrared radiation energy or rays. In some embodiments, a bioceramic is provided that emits, transmits, or reflects infrared radiation, which is far infrared radiation and has a wavelength of about 1 µm to 1 mm. In further or additional embodiments, a bioceramic composition is provided that emits, transmits, or reflects infrared radiation at a wavelength of about 3 to 15 microns. In further or additional embodiments described herein, a bioceramic composition is provided that provides the bioceramic with at least 80% reflectivity at room temperature of 25° C. in the infrared range of about 7 to 12 microns.

The emissivity of the bioceramic material can be measured, for example, with a calorimeter or a Flir thermographic camera. The calorimeter can be used to measure the amount of thermal energy that can be received, stored and/or released by the bioceramic-containing body wear item. The Flir thermographic camera can generate a thermal image of various types of body wear items containing the bioceramic of the invention. The Flir thermographic camera can detect up to a thousand measurement points in each thermal image and provide emissivity data for each image.

The bioceramic composition according to the invention is formulated in such a way that it has the desired refractory properties.

In some embodiments, the bioceramic of the invention reflects about 99% of received infrared energy or rays, about 98% of received infrared energy or rays, about 97% of received infrared energy or rays, about 96% of received infrared energy or rays, about 95% of received infrared energy about 94% of infrared energy or rays received, about 93% of infrared energy or rays received, about 92% of infrared energy or rays received, about 91% of infrared energy or rays received, about 90% of infrared energy or rays received, about 89 % of infrared energy or rays received, about 88% of infrared energy or rays received, about 87% of infrared energy or rays received, about 86% of infrared energy or rays received, about 85% of infrared energy or rays received, about 84% of infrared energy or rays received rays, about 83% of the received infrared energy or rays, about 82% of the received infrared energy or rays, about 81% of infrared energy or rays received, about 80% of infrared energy or rays received, about 79% of infrared energy or rays received, about 78% of infrared energy or rays received, about 77% of infrared energy or rays received, about 76% of infrared energy or rays received, about 75% of infrared energy or rays received, about 74% of infrared energy or rays received, about 73% of infrared energy or rays received, about 72% of infrared energy or rays received, about 71% of infrared energy or rays received about 70% of infrared energy or rays received, about 65% of infrared energy or rays received, about 60% of infrared energy or rays received, about 55% of infrared energy or rays received, about 50% of infrared energy received or rays, about 45% of the received infrared energy or rays, about 40% of the received infrared energy or rays, an eye about 35% of infrared energy or rays received, about 30% of infrared energy or rays received, about 25% of infrared energy or rays received, about 20% of infrared energy or rays received, about 15% of infrared energy or rays received, about 10% of infrared energy or rays received energy or rays or about 5% of the received infrared energy or rays.

In some cases, the bioceramics according to the invention reflect more than 99% of the received infrared energy or rays, more than 98% of the received infrared energy or rays, more than 97% of the received infrared energy or rays, more than 96% of the received infrared energy or rays, more than 95% of the received infrared energy or More than 94% of infrared energy or rays received More than 93% of infrared energy or rays received More than 92% of infrared energy or rays received More than 91% of infrared energy or rays received More than 90% of infrared energy or rays received More than 89% more than 88% of received infrared energy or rays, more than 87% of received infrared energy or rays, more than 86% of received infrared energy or rays, more than 85% of received infrared energy or rays, more than 84% of received infrared energy or rays , more than 83% of the received infrared energy or rays, more than 82% of the received infrared energy more than 81% of infrared energy or rays received, more than 80% of infrared energy or rays received, more than 79% of infrared energy or rays received, more than 78% of infrared energy or rays received, more than 77% of infrared energy or rays received, more than 76% of infrared energy or rays received, more than 75% of infrared energy or rays received, more than 74% of infrared energy or rays received, more than 73% of infrared energy or rays received, more than 72% of infrared energy or rays received, more than 71% of infrared energy received more than 70% of infrared energy or rays received, more than 65% of infrared energy or rays received, more than 60% of infrared energy or rays received, more than 55% of infrared energy or rays received, more than 50% of infrared energy or rays received, more than 45 % of infrared energy or rays received, more than 40% of infrared energy or rays received, more than 35% of infrared received more than 30% of received infrared energy or rays, more than 25% of received infrared energy or rays, more than 20% of received infrared energy or rays, more than 15% of received infrared energy or rays, more than 10% of received infrared energy or rays or more than 5% of the received infrared energy or rays.

In some cases, the bioceramic of the invention 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 less than 94% of infrared energy or rays received, less than 93% of infrared energy or rays received, less than 92% of infrared energy or rays received, less than 91% of infrared energy or rays received, less than 90% of infrared energy or rays received, less than 89% less than 88% of received infrared energy or rays, less than 87% of received infrared energy or rays, less than 86% of received infrared energy or rays, less than 85% of received infrared energy or rays, less than 84% of received infrared energy or rays , less than 83% of received infrared energy or rays, less than 82% of received infrared energy less than 81% of infrared energy or rays received, less than 80% of infrared energy or rays received, less than 79% of infrared energy or rays received, less than 78% of infrared energy or rays received, less than 77% of infrared energy or rays received, less than 76% infrared energy or rays received, less than 75% infrared energy or rays received, less than 74% infrared energy or rays received, less than 73% infrared energy or rays received, less than 72% infrared energy or rays received, less than 71% infrared energy received less than 70% of infrared energy or rays received, less than 65% of infrared energy or rays received, less than 60% of infrared energy or rays received, less than 55% of infrared energy or rays received, less than 50% of infrared energy or rays received, less than 45 % of infrared energy or rays received, less than 40% of infrared energy or rays received, less than 35% of infrared received less than 30% of received infrared energy or rays, less than 25% of received infrared energy or rays, less than 20% of received infrared energy or rays, less than 15% of received infrared energy or rays, less than 10% of received infrared energy or rays or less than 5% of received infrared energy or beams.

In some embodiments, the bioceramic reflects far infrared radiation energy toward the subject's body, and in some embodiments, the bioceramic reflects far infrared radiation energy away from the subject's body. Bioceramics can provide a cooling effect when it reflects infrared energy away from the body. In some embodiments, the bioceramic is adjacent to or adjacent to the insulating material. In some embodiments, an article containing the insulated bioceramic provides a cooling effect to the subject, wherein, when heated or exposed to heat, the bioceramic reflects far-infrared infrared rays away from the subject.

In some embodiments, the body-worn article of the invention comprises an insulating material that is in contact with, or adjacent to, the bioceramic. An insulating material may be used in embodiments in which the body-worn material containing the bioceramic is made to reflect far infrared radiation energy away from the subject's body. In some embodiments, the implementation of the insulating material is a material with low thermal conductivity, and prevents the reflection of radiation energy in the far infrared spectrum in the other direction. Various types of materials can be used to reflect infrared radiation, with non-limiting examples of insulating materials including rubber, glass, paper, plastic, wood, fabric, foil, or polystyrene foam.

The body-worn article of the invention may provide a therapeutically effective amount of infrared radiation to a subject. In some instances, the body-worn article is a T-shirt containing the bioceramic, and when exposed to heat, the T-shirt containing the bioceramic provides at least 1.5 J/cm ² far infrared rays to the subject. In some cases, the body-worn article may be a sports uniform, sports accessory, or sports equipment, including, but not limited to, orthopedic inserts, sports shoes, wetsuits, survival gear, t-shirts, shorts, wrist bands, arm bands, arm bands. head, gloves, jackets, trousers, hats and backpacks, skis, ski poles, snowboards, skateboards, roller skates, bicycles, surfboards, water skis, jet skis, diving equipment, cables, chains, goggles and/or blankets. In some embodiments, the body-worn article is a sports accessory, including, but not limited to, a blanket. In some embodiments, the body-worn article is designed for use in orthopedic applications, including, but not limited to, orthopedic inserts, shoes, and the like. In some embodiments, the item is a body patch (e.g., a patch that is made to adhere or not adhere to the skin, such as transdermal patches, transdermal hydrogel patches, and the like), an adhesive tape, such as kinesio, non-stick tape, pads, insoles, linens including sheet, mattress, bedspread, pillow and/or pillowcase, body support systems, massage roll, toner, soap, tape, glassware, furniture, paint, ink, sticker, carpet , mat, food and/or drink containers, drinking containers (e.g. bottle or jar), headgear (e.g. helmet, hat, etc.), shoes (e.g. boots, sneakers, sandals, etc.) .), headphones, surface, sports surface, artificial turf, etc. In some cases, the body wear item is a T-shirt, pants, shorts, dress, skirt, jacket, hat, underwear, socks, cap, gloves, scarf, diaper, blanket, blanket, duvet cover, mattress teak, mattress topper, etc. P. In another embodiment, the article is a body support system selected from a knee pad, elbow support, compression hand cuff, compression leg cuff, wrist straps, and the like.

In some embodiments, the subject matter described herein provides 1 to 45 J/cm ² , 2-10 J/cm ² , or 4-6 J/cm ² far infrared or radiation energy to a subject.

In certain embodiments, a bioceramic composition that provides at least 1, 1.5, at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least at least 8, at least 9, at least 10,

By lesser measure eleven, By lesser measure 12, By lesser measure 13, By lesser measure 14, By lesser measure 15, By lesser measure 16, By lesser measure 17, By lesser measure 18, By lesser measure 19, By lesser measure 20, By lesser measure 21, By lesser measure 22, By lesser measure 23, By lesser measure 24, By lesser measure 25, By lesser measure 26, By lesser measure 27, By lesser measure 28, By lesser measure 29, By lesser measure thirty, By lesser measure 31, By lesser measure 32, By lesser measure 33, By lesser measure 34, By lesser measure 35, By lesser measure 36, By lesser measure 37, By lesser measure 38, By lesser measure 39, By lesser measure 40, By lesser measure 41, By lesser measure 42, By at least 43, at least 44, or about 45 J/ ^cm2 radiation energy in the far field

infrared spectrum or radiation to the subject.

In some cases, a body wear item as described may provide no more than 1.5, no more than 2, no more than 3, no more than 4, no more than 5, no more than 6, no more than 7, no more than 8, no more than 9, no more than 10, no more than 11, no more than 12, no more than 13, no more than 14, no more than 15, no more than 16, no more than 17, no more than 18, no more than 19, no more than 20, no more than 21, no more 22, max 23, max 24, max 25, max 26, max 27, max 28, max 29, max 30, max 31, max 32, max 33, max 34, max 35, no more than 36, no more than 37, no more than 38, no more than 39, no more than 40, no more than 41,

- 10 041903 not more than 42, not more than 43, not more than 44 or not more than 45 J/cm ² of radiation energy in the far infrared region or radiation to the subject.

In some cases, a body wear item as described provides 1.5 to 45 J/ ^cm2 , 1.5 to 40 J/ ^cm2 , 1.5 to 35 J/ ^cm2 , 1.5 to 30 J / cm ² , from 1.5 to 25 J / cm ² , from 1.5 to 20 J / cm ² , from 1.5 to 15 J / cm ² , from 1.5 to 10 J / cm ² , from 1.5 to 5 J/ ^cm2 , 2 to 45 J/ ^cm2 , 2 to 40 J/ ^cm2 , 2 to 35 J/ ^cm2 , 2 to 30 J/ ^cm2 , 2 to 25 J/cm ² , 2 to 20 J/cm ² , 2 to 15 J/cm ² , 2 to 10 J/cm ² , 2 to 5 J/cm ² far infrared radiation energy or radiation to the subject . In some instances, the body-worn article is a T-shirt, and said T-shirt delivers no more than 45 J/cm ² far infrared or radiation energy to the subject.

Infrared energy can be absorbed, reflected or emitted by molecules. In many cases, the thermal radiation emitted by objects at or near room temperature (approximately 25°C) is infrared.

For example, in certain applications of the subject matter described herein, infrared energy is emitted or absorbed by molecules during rotational and/or vibrational movements. In certain embodiments, the bioceramic materials provided herein provide infrared energy that induces vibrational modes in the molecule by changing the dipole moment. In some embodiments, the implementation of the absorption of heat by the bioceramic according to the present invention causes vibrational modes in at least one molecule of the bioceramic through changes in the dipole moment. In addition, infrared radiant energy is, in certain embodiments, absorbed and reflected by molecules in the bioceramic as they change their rotational-vibrational energy. In further or additional embodiments provided herein, a bioceramic is provided that comprises a ceramic material composition and vibrational technology that provides enhanced biomodulatory properties upon contact with or application to a subject, including as one example a human subject.

Products.

One aspect of the articles, compositions, methods, devices, and systems described herein is an article containing a composition that includes a bioceramic, wherein, when heated or exposed to heat, the bioceramic provides a biomodulatory or physiological effect when the article is applied to a human.

In some embodiments, articles that contain a bioceramic composition and articles coated with bioceramics are provided. In one embodiment, the bioceramic composition is present as a coating on at least a portion of the surface of the article (eg, on the inner or outer surface of the article) or incorporated directly into the substrate prior to or during manufacture of the article itself. In another embodiment, the substrate is a polymer, fabric or metal material.

In some embodiments, bioceramic compositions are provided that further comprise a support, binder, solvent, polymer, or ink. In some embodiments, a bioceramic composition is provided that further comprises a support that includes at least one elastomer. In some embodiments, a bioceramic composition is provided that further comprises a polymer selected from the group consisting of polyoxybenzylmethylene glycol hydride, polyvinyl chloride, polystyrene, polyethylene, polypropylene, polyacrylonitrile, polyvinyl butyral, polylactic acid, and combinations thereof. In further or additional embodiments, a bioceramic composition is provided comprising an elastomer that is selected from the group consisting of polychloroprene, nylon, polyvinyl chloride based elastomer, polystyrene based elastomer, polyethylene based elastomer, polypropylene based elastomer, polyvinyl butyral based elastomer, silicone , thermoplastic elastomer and combinations thereof.

In some embodiments, an article is provided that contains a bioceramic composition that further comprises a substrate that includes a material selected from the group consisting of wool, silk, cotton, canvas, jute, glass, nylon, polyester, acrylic, elastane , polychloroprene, laminated fabrics containing foamed polytetrafluoroethylene, and combinations thereof. In still other or additional embodiments, an article is provided that contains a bioceramic composition that further comprises a polygel.

For example, in one embodiment, a polymeric article is obtained by mixing a bioceramic composition with a polymeric substrate, or alternatively by depositing a bioceramic on a substrate, while the substrate is in liquid or flowable form. In some embodiments, the amount of the bioceramic composition included in or applied to the polymeric substrate may be any suitable amount that reflects a sufficient amount of far infrared radiation energy. In one embodiment, the bioceramic composition is added in an amount of about 1 to about 75% by weight of

- 11 041903 of the total weight of the product. In another embodiment, the bioceramic composition is added in an amount of from about 0.01 to about 25 wt.% of the total weight of the product. In yet another embodiment, the bioceramic composition is added in an amount of from about 3 to about 20 wt.% of the total weight of the product. In another embodiment, the bioceramic composition is added in an amount of from about 7 to about 13 wt.% of the total weight of the product. In another embodiment, the polymeric substrate is in the form of a fabric substrate, such as a T-shirt, which is described in more detail below.

The polymeric substrate includes any polymer that is suitable for making the product. For example, the polymeric substrate includes at least one elastomeric polymer or at least one non-elastomeric polymer. As bonded polymers and polymer systems, polymer mixtures are used, which include continuous and/or dispersed phases, and the like.

Elastomers include, but are not limited to, viscoelastic polymers such as, for example, natural rubbers, synthetic rubbers, highly elastic and rubbery polymeric materials. One example of synthetic rubber is polychloroprene (neoprene). In one embodiment, the elastomer is selected from polychloroprene, nylon, polyvinyl chloride based elastomer, polystyrene based elastomer, polyethylene based elastomer, polypropylene based elastomer, polyvinyl butyral based elastomer, silicone, thermoplastic elastomer and combinations thereof.

Thermoplastic elastomers (TPE) are composite materials made from a combination of an elastomeric material and a thermoplastic material. TPEs are elastomeric materials that are dispersed and crosslinked into a continuous phase of a thermoplastic material. Exemplary TPEs include Santoprene® available from Advanced Elastomers Systems, Inc. and Sarlink® available from DSM Elastomers, Inc.

In one embodiment, the non-elastomer is selected from a group of polymers that includes, but is not limited to, polyoxybenzylmethylene glycol hydride, polyvinyl chloride, polystyrene, polyethylene, polypropylene, polyacrylonitrile, polyvinyl butyral, polylactic acid, and the like.

With respect to an article that includes a fabric substrate and a bioceramic composition, the bioceramic composition may be applied to clothing by any process known in the clothing/fabric art using a liquid or fluid carrier that contains the bioceramic composition. For example, a screen printing process, a spot application process, a binder solution application process, a visual pattern repeating process, or any other suitable method may be used. Screen printing is a printing process that uses a form called a frame or screen, which is a very fine mesh fabric that remains permeable to ink in areas of the image to be reproduced and impermeable in other areas. The spot application process uses special devices, such as a bioceramic-containing syringe, to apply the ceramic to specific parts of a body-worn article. The binder solution process is used to dip fabrics into solutions or suspensions containing bioceramics, in some cases this is used to impregnate fabrics with bioceramics. The visual pattern repeat process is used to add a single pattern or pattern repeats to an article to be worn on the body. In one embodiment, the bioceramic composition may be incorporated into an ink, which is then applied by screen printing to at least a portion of the surface of a fabric substrate.

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 which are used to make a fabric substrate.

The fabric substrates used herein include fabric or textile substrates made by any method known to those skilled in the textile arts. Such techniques include, but are not limited to, weaving, knitting, crocheting, felting, knotting, reinforcing, and the like. Suitable starting materials for fabric substrates include natural or synthetic (eg, polymeric) fibers and filaments. In one embodiment, the fabric backing includes, but is not limited to, a material selected from wool, silk, cotton, canvas, jute, glass, nylon, polyester, acrylic, elastane, polychloroprene, laminated fabrics containing expanded polytetrafluoroethylene (e.g., fabric Gore-Tex®) and combinations thereof.

With respect to an article that includes a metal substrate, the bioceramic composition is optionally applied to the metal in liquid/fluid form by a process known in the art of metalworking. For example, the bioceramic composition is optionally incorporated into a liquid/fluid carrier such as, but not limited to, paint, sealant, lacquer, and the like, and applied to at least a portion of the surface of a metal substrate. The amount of bioceramic composition added to the paint or other liquid/fluid carrier may be any suitable amount.

- 12 041903

Suitable metal substrates for use herein include any metal substrate that is useful for making an article containing the bioceramic composition. Exemplary metal substrates include pure metals and alloys. In one embodiment, the metal 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, etc.

Item to be worn on the body (clothes).

In fact, any article to which a bioceramic composition can be applied or incorporated is suitable. In one embodiment, the article is selected from a body-worn article (e.g., wearables 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, pads, insoles, compression sleeves, uniforms, casual/home wear, bedding including sheets, mattresses, bedspreads, pillows and pillowcases, body support systems, supports, massage rolls, lotions, soaps, tape, glassware, furniture, paint, ink, stickers, carpets, mats, food and/or drink containers, covers for beverage containers (e.g. bottles or cans), hats (e.g. helmets, hats, etc.), footwear (e.g. boots, sneakers, sandals, etc.), headphones, surface, sports surface, artificial turf, etc.

In some embodiments, the body-worn article includes sportswear, sports accessories, or sports equipment, including, but not limited to, orthopedic inserts, running shoes, uniforms, sports shoes, insoles, compression sleeves, wetsuits, life aids, t-shirts, shorts, headbands. on the wrist, armbands, hats (e.g. beanies), headbands, gloves, jackets, trousers, hats and backpacks, skis, ski poles, snowboards, skateboards, roller skates, bicycles, surfboards, water skis, water motorcycles, diving equipment, cables, chains, goggles and/or blankets. In some embodiments, the body-worn article is a sports accessory, including but not limited to blankets. In some embodiments, the item is designed for use in orthopedic applications, including, but not limited to, orthopedic inserts, shoes, and the like.

In another embodiment, the article is a garment selected from T-shirts, trousers, shorts, dresses, skirts, jackets, hats, underwear, socks, caps, gloves, scarves, diapers, and the like. In yet another embodiment, the article is a piece of jewelry selected from bracelets, chains, earrings, medallions, pendants, rings, and the like. In still another embodiment, the article is a bed linen selected from duvets, sheets, pillows, pillowcases, blankets, duvet covers, mattress ticks, mattress pads, and the like. In another embodiment, the article is a body support system selected from knee pads, elbow supports, compression sleeves, compression leg sleeves, wrist straps, and the like. In some embodiments, the clothing includes casual/home wear.

In further or additional embodiments, an article is provided that contains a bioceramic composition, or an article to which a bioceramic is applied, the article being selected from the group consisting of clothing, jewelry, patches, pads, insoles, bedding, body supports, roller skates, lotions, soaps, tape, glassware, furniture, paint, ink, stickers, carpets, mats, food and/or drink containers, drink container covers, headgear, shoes, headphones, and combinations thereof. In further or additional embodiments, the article includes an article to be worn on the body, such as clothing. In some embodiments, the body-worn article is a casual/home wear. In some embodiments, the body-worn article is a sportswear. In some embodiments, the body-worn article includes a T-shirt, jacket, shorts, or trousers. In still other embodiments, the body-worn article includes a wrist band, pad, knee brace, ankle brace, sleeve, compression sleeve, headgear (eg, headband), patch, shoe, or insole.

In some embodiments, the product is a surface, sports surface, or artificial turf.

biomodulatory effect.

Another aspect of the articles, compositions, methods, devices, and systems described herein is a bioceramic composition that provides a biomodulatory or physiological effect when heated or exposed to heat, such as human radiation. In some embodiments, the biomodulatory or physiological effect includes modulating pain, increasing muscle endurance, increasing body resistance, increasing strength.

- 13 041903 muscle, modulation of the cardiorespiratory system, such as an increase in respiratory volume of the lungs, an increase in flexibility, modulation of cellular metabolism, an improvement in analgesia, an antioxidant effect, an antifibromyalgic effect, a decrease in inflammation, a decrease in oxidative stress, a modulation of cytokine levels, a modulation of blood circulation, a decrease in cold intolerance, amelioration of the symptom of arthritis or vascular disease, increase in skin perfusion, decrease in heart rate, decrease in blood pressure, faster recovery from injury or exercise, aesthetic effect such as reduction of cellulite in the subject, improvement in quality of life.

The bioceramic composition according to the invention has a biomodulatory or physiological effect in various subjects. In some embodiments, the subjects are humans, non-human primates such as chimpanzees, and other species of monkeys and marmosets; farm animals such as cattle, horses, sheep, goats, pigs; pets such as rabbits, dogs and cats; laboratory animals, including rodents such as rats, mice and guinea pigs, and the like. The subject can be of any age. In some embodiments, the subjects are elderly, adults, adolescents, preteens, children, preschool children, infants.

In some embodiments, the biomodulatory or physiological effect is a change in body composition. Body composition can be described by body mass index, fat mass index, skeletal muscle mass index, percentage of body fat, or any combination thereof. Various methods can be used to measure body composition, such as bioimpedance analysis. The bioimpedance analyzer can be used in bioimpedance analysis to determine total body water (TBW). TBW can be used to calculate lean (lean) body mass and then subtract body fat from total body mass.

In some embodiments, the implementation of the biomodulatory or physiological effect is an increase or decrease in the levels of expression of the biomarker. Biomarkers broadly refer to any characteristics that can be 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 herein refers primarily to biomarkers that have biophysical properties and can be measured in biological samples (eg, saliva, plasma, serum, cerebrospinal fluid, bronchoalveolar lavage, biopsy material). Examples of biomarkers include nucleic acid-based biomarkers (eg, oligonucleotides or polynucleotides), peptide or protein biomarkers, cytokines, hormones, or lipids. In some embodiments, an article containing a bioceramic composition of the invention has a biomodulatory or physiological effect on the biomarker.

In some embodiments, the biomarker is a cytokine. Non-limiting examples of cytokines include a) IL-2 subfamily cytokines such as erythropoietin (EPO) and thrombopoietin (TPO); b) the interferon (IFN) subfamily, eg IFN-γ; c) IL-6 subfamily; d) IL-10 subfamily; e) an IL-1 subfamily, eg IL-1 and IL-18, f) IL-17, or g) a tumor necrosis factor family, eg tumor necrosis factor alpha (TNF-alpha or TNF-α). In some embodiments, an article containing a bioceramic composition of the invention has a biomodulatory or physiological effect on a cytokine. In some embodiments, the cytokine is associated with inflammation, pain, muscle endurance, modulation of the cardiorespiratory system, modulation of cellular metabolism, analgesia, cellular oxidation, fibromyalgia effect, or other condition described herein.

In some embodiments, the 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 stimulated by reactive oxygen species. This usually refers to a process in which reactive ketones or aldehydes are formed that can react with 2,4-dinitrophenylhydrazine (DNPH) to form hydrazones. Direct oxidation of the side chains of lysine, arginine, proline and threonine residues, including other amino acids, in the carbonylation reaction of the original protein provides DNPH-detectable protein products. In some embodiments, an article containing a bioceramic composition of the invention has a biomodulatory or physiological effect on a protein. In some embodiments, the protein is associated with inflammation, pain, muscle endurance, modulation of the cardiorespiratory system, modulation of cellular metabolism, analgesia, cellular oxidation, fibromyalgia effect, or other condition described herein.

In some embodiments, the 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. This is a process in which free

- 14 041903 dicals remove electrons from lipids in cell membranes, resulting in cell damage. In some embodiments, an article containing a bioceramic composition of the invention has a biomodulatory or physiological effect on lipid. In some embodiments, the lipid is associated with inflammation, pain, muscle endurance, modulation of the cardiorespiratory system, modulation of cellular metabolism, analgesia, cellular oxidation, fibromyalgia effect, or other condition described herein.

In some embodiments, the bioceramic composition provides a biomodulatory or physiological effect, which is a change that is statistically significant. In other or additional embodiments, the implementation of the biomodulatory or physiological effect includes a change that is at least 5%. In other or additional embodiments, the implementation of the biomodulatory or physiological effect includes a change that is at least 10%. In still other or additional embodiments, the implementation of the biomodulatory or physiological effect is the reduction of pain, which is caused by physical activity. In still other or additional embodiments, the biomodulatory or physiological effect is a reduction in inflammation.

The time required for the bioceramic according to the invention to modulate the effect of the biomarker often depends on the predominant amount, distribution and concentration of the bioceramic in contact with the subject. In some embodiments, the biomodulatory or physiological effect of the bioceramic of the invention 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 body containing bioceramics.

adjuvant therapies.

The bioceramic of the invention can provide a variety of beneficial therapeutic effects to a subject who wears a body wear item containing the bioceramic. The far-infrared energy provided by bioceramics can be beneficial in increasing blood circulation, reducing pain, strengthening the cardiovascular system, reducing joint stiffness and inflammation, and repairing skin cells. Far infrared radiation energy can provide an analgesic effect to a subject. The examples described in the present invention provide a qualitative and quantitative measurement of bioceramics in a variety of physiological parameters. In some cases, the bioceramic-containing body wear item may contain another active compound. In other cases, a therapeutic regimen that uses bioceramics can be carried out in conjunction with adjuvant therapy.

Bioceramics can be formulated with another active compound/substance. In some cases, bioceramics are formulated with a pharmaceutically active or inactive compound that provides the desired smell, feel, texture. For example, a body-worn article, such as a patch, may be made using one or more additional active or inactive materials. One or more other substances may be, for example, menthol, cinnamon, mint, cayenne pepper (capsaicin), camphor, mustard, medicinal herbs, compounds derived from such herbs, or substitutes thereof. The ratio of agent (e.g. bioceramic) to other substance can 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.

In other instances, the bioceramic composition may have an analgesic effect on a subject who is wearing a body wear item such as a patch, t-shirt, shorts, etc. containing the bioceramic. In some cases, the analgesic effect is provided exclusively by bioceramics and an additional substance. Multiple doses of active substances such as menthol, cinnamon, mint, cayenne pepper (capsaicin), mustard, medicinal herbs, compounds derived from such herbs, or substitutes thereof, may be incorporated into the body wear article of the invention. Non-limiting examples of medicinal herbs and illustrative species include the following: acai (Euterpe oleracea), alfalfa (Medicago sativa), aloe vera (e.g. Aloe barbadensis), arnica (Arnica montana), Brazilian pepper (Schinus terebinthifolius), ashoka (Saraca indica), spurge (Euphorbia hirta), astragalus (Astragalus propinquus), barberry (Berberis vulgaris), belladonna (Atropa belladonna), bilberry (Vaccinium myrtillus), bitter cucumber (Momordica charantia), Veronia leaves (Vernonia amygdalina), wild orange (Citrus x aurantium) ), boswellia (Boswellia serrata), black cohosh (Actaea racemosa), blessed knykus (Cnicus benedictus), blueberry (genus Vaccinium), burdock (Arctium lappa), tobacco tree (Solanum mauritianum), cat's claw (Uncaria tomentosa), kars caensky pepper (Capsicum annuum), celery (Apium graveolens), chamomile (for example: Matricaria recutita and Anthemis nobilis), chaparral (Larrea tridentata), vitex (Vitex agnus-castus), chili pepper (Capsicum frute scens), cinchona (the genus contains about 38 species of trees, the bark of which is a source of alkaloids, including quinine), carnation du

- 15 041903 Syzygium aromaticum, coffee bean (Cassia occidentalis), comfrey (Symphytum officinale), cranberry (Vaccinium macrocarpon), dandelion (Taraxacum officinale), woolly foxglove (Digitalis lanata), Chinese angelica (Angelica sinensis), black elderberry (Sambucus nigra), Chinese ephedra (Ephedra sinica), eucalyptus (Eucalyptus globulus), European thong (Viscum album), evening primrose (Oenothera spp.), fenugreek (Trigonella foenum-graecum), maiden tansy (Tanacetum parthenium), flax common (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 (especially Crataegus monogyna and Crataegus laevigata), henna (Lawsonia Inermis), hoodia (Hoodia gordonii), horse chestnut (Aesculus hippocastanum), horsetail (Equisetum arvense), Jamaican swine (Piscidia erythrina/Piscidia piscipula), lavender (Lavandula angustifolia), lemon (Citrus limon), licorice root (Glycyrrhiza glabra), lotus (Nelumbo nucifera), calendula (Calendula officinalis), marshmallow (Althaea officinalis), noni (Morinda citrifolia), opium poppy (Papaver somniferum), oregano (Origanum vulgare), mint (Mentha x piperita), istod (Paniculata L), podofilox (podofilox), sucupira (Pterodon emarginatus), sweet savory (Satureja hortensis), a plant called thunder god vine (Tripterygium wilfordii), turmeric (Curcuma longa), willow bark (Salix alba), and white willow bark (Salix alba).

In some instances, the bioceramic composition may have an anti-inflammatory effect on a subject who is wearing a body wear item such as a patch, shirt, shorts, etc. containing the bioceramic. In some cases, the anti-inflammatory effect is provided by a combination of bioceramics and an additional substance. A plurality of doses of anti-inflammatory agents may be administered to the body-worn article of the invention. Non-limiting examples of substances, herbs, and exemplary species that may provide anti-inflammatory effects include Alfalfa alfalfa (Medicago sativa L.), aloe vera gel (Aloe Vera Gel, Aloe vera), andiroba oil (Carapa guianensis), ashwagandha root (Withania somnifera ), poplar (Populus spp), Peruvian balsam tree (Myroxylon pereirae), barberry (Berberis vulgaris L.), hare barley (Hordeum vulgare), blueberry (Vaccinium myrtillus), birch bark and leaves (Betula alba), black cumin oil (Nigella sativa), Eupatorium perfoliatum, Borage (Borago officinalis) seed oil, Frankincense Indian frankincense, Frankincense Indian frankincense, thurifera frankincense, Bupleurum chinense, Calendula (Calendula officinalis), Cat's claw (Uncaria tomentosa), chamomile (Matricaria recutita), starflower medium (Stellaria media), chicory root (Cichorium intybus), chrysanthemum (Chrysanthemum morifolium, C. sinense), coriander (Cori andrum sativum), Copai balsam (Copaifera Officinalis), Coptis (Coptis spp), Stigma corn columns (Zea mays), Cornflower (Centaurea cyanus), Cumin (Cuminum cyminum), Devil's claw (Harpagophytum procumbens), Echinacea (Echinacea angustifolia) , feverfew (Tanacetum parthenium), gnarled boletus (Scrophularia nodosa), ginkgo biloba (Ginkgo biloba L.), grindelia (Grindelia spp), immortelle oil (Helichrysum angustifolium), Jamaican dogwood (Piscidia piscipula), steeple (Eupatorium purpureum), marshmallow root (Althaea officinalis L), mullein (Verbascum spp.), oats (Avena sativa L), mahonia root (Mahonia aquifolium), pineapple (Ananas comosus), sarsaparilla root (Smilax sarsaparilla), sea buckthorn oil (Hippophae rhamnoides), Shea Butter (Butyrospermum parkii), Saponaria (Saponaria officinalis), Aralia (Aralia racemosa), Spilanthes (Spilanthes acmella), Tamanu Oil (Calophyllum inophyllum), Turmeric (Curcuma longa L), White Peony Root (Paeonia albi) flora), white willow bark (Salix Alba), wild cherry bark (Prunus serotina), virgin hazel (Hamamelis virginiana), yarrow (Achillea millefolium) and yucca root (Yucca spp).

In some cases, the active substance is an analgesic agent. In some cases, many doses are in the range of about 1 to 200 mg; about 5 to 1000 mg, about 10 to 25 mg, up to 500 mg, about 50 to 250 mg, about 100 to 200 mg, about 1 to 50 mg, about 50 to 100 mg, about 100 to 150 mg, about 150 to 200 mg, about 200 to 250 mg, about 250 to 300 mg, about 300 to 350 mg, about 350 to 400 mg, about 400 to 450 mg, about 450 to 500 mg, about 500 to 550 mg, about 550 to 500 mg, about 600 to 650 mg, about 650 to 700 mg, about 700 to 750 mg, about 750 to 800 mg, about 800 to 850 mg , about 850 to 900 mg, about 900 to 950 mg, or about 950 to 1000 mg.

In some cases, multiple administration to a subject is carried out over a period of time. The time period may be about, not less than or not more than 30 seconds, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 min.

In addition to the beneficial effects of using body wear items containing bioceramic, subjects can combine additional treatment regimens using bioceramic body wear as adjuvant therapies. For example, physical therapy can be used as an adjuvant therapy regimen for a bioceramic treatment regimen. Additional examples of adjuvant therapies include physical therapy, physical rehabilitation, hydrotherapy, Pilates, or other suitable complementary therapy.

The adjuvant therapy regimen may be administered to the subject in parallel or concurrently with a therapy regimen involving the use of a bioceramic body-worn article. Mode

- 16 041903 adjuvant therapy can be carried out in a variety of settings, such as the subject's home, fitness centers or gyms, outpatient clinics or offices and health clinics, rehabilitation hospitals, nursing care facilities, sanatorium-type medical institutions, private homes, educational and research centers, schools, hospices, workplaces, or other settings.

Non-invasive methods for providing biomodulation in a subject.

Another aspect of the subject matter of the invention described herein is a non-invasive method of providing a biomodulatory or physiological effect to or for a subject, comprising bringing an article containing bioceramic into contact with the skin of the subject, wherein, when heated or exposed to heat, the bioceramic composition provides thermal radiation in the far field. infrared spectrum and biomodulatory or physiological effect on the subject in a non-invasive manner.

For example, in some embodiments, a bioceramic composition is provided that, when heated or exposed to heat, provides a biomodulatory or physiological effect when the article is applied to a subject, comprising:

a) about 20 to 80 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ );

b) about 1 to 30% tourmaline by weight;

c) about 1 to 40 wt.% alumina (Al ₂ O ₃ );

d) about 1 to 40 wt.% silicon dioxide (SiO ₂ );

e) about 1 to 20 wt.% zirconium oxide (ZrO ₂ );

the quantities are presented based on the total weight of the bioceramic composition.

In other or additional embodiments, a bioceramic composition is provided that, when heated or exposed to heat, provides a biomodulatory or physiological effect when the article is applied to a subject, comprising:

a) about 40 to 60 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ );

b) about 5 to 15% tourmaline by weight;

c) about 15 to 25 wt.% alumina (Al ₂ O ₃ );

d) about 10 to 20 wt.% silicon dioxide (SiO ₂ );

e) about 1 to 20 wt.% zirconium oxide (ZrO ₂ );

the quantities are presented based on the total weight of the bioceramic composition.

In some embodiments, the implementation of the bioceramic composition contains kaolinite in an amount of about 45 to 55 wt.%. In other or additional embodiments, the implementation provides a bioceramic composition that contains kaolinite in an amount of from about 47 to 53 wt.%. In other or additional embodiments, the implementation provides a bioceramic composition that contains kaolinite in an amount of from about 48 to 52 wt.%.

In some embodiments, a bioceramic composition is provided that contains:

a) about 50 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ );

b) about 10 wt.% tourmaline;

c) about 18 wt.% alumina (Al ₂ O ₃ );

d) about 14 wt.% silicon dioxide (SiO ₂ );

e) about 8 wt.% zirconium oxide (ZrO ₂ ).

In some embodiments, the biomodulatory or physiological effect includes modulation of pain, increased muscle endurance, modulation of the cardiorespiratory system, modulation of cellular metabolism, analgesia, antioxidant effect, antifibromyalgic effect, reduction of inflammation, reduction of oxidative stress, modulation of endoplasmic reticulum stress, modulation of cytokine levels, modulation of circulation , reducing cold intolerance, ameliorating a symptom of arthritis or vascular disease, increasing skin perfusion, decreasing heart rate, lowering blood pressure, an aesthetic effect such as a reduction in body size, weight loss, or reduction in cellulite in a subject.

In some embodiments, the bioceramic composition provides a biomodulatory or physiological effect that includes a change that is statistically significant. In other or additional embodiments, the implementation of the biomodulatory or physiological effect includes a change that is at least 5%.

In some embodiments, an article is provided that contains a bioceramic composition, or an article to which a bioceramic is applied, said article being selected from the group consisting of body wear, jewelry, patches, pads, insoles, bed linen, bedding supports. body, roller skates, lotions, soaps, tape, glassware, furniture, paint, ink, stickers, carpets, mats, food and/or drink containers, drink container covers, headbands, shoes, headphones, and combinations thereof . In other or additional embodiments, the article includes an article to be worn on the body, such as

- 17 041903 clothes. In some embodiments, the body-worn article includes a T-shirt, jacket, shorts, or trousers. In still other embodiments, the body-worn article includes a wrist band, pad, knee brace, ankle brace, sleeve, or patch. In some embodiments, the product includes a surface, sports surface, or artificial turf.

The bioceramic composition according to the invention may be a combination of any of the compounds described herein with other chemical components such as carriers, stabilizers, diluents, dispersing agents, suspending agents, thickeners and/or adjuvants. The bioceramic can be administered directly or indirectly to the skin of a subject. In some cases, active compounds can be applied to the product and directly affect the subject. In other cases, the active compounds may be applied directly to the subject's skin.

Manufacturing methods

Another aspect of the subject matter described herein is a method for manufacturing an article, comprising the following steps:

a) preparation of the bioceramic solution;

b) applying the solution to the product;

while the solution when applied to the product contains:

about 20 to 80 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ );

about 1 to 30 wt.% tourmaline;

about 1 to 40 wt.% alumina (Al ₂ O3);

about 1 to 40% by weight silicon dioxide (SiO2);

about 1 to 20 wt.% zirconium oxide (ZrO ₂ ), while the amounts are based on the total weight of the bioceramic composition.

In other or additional embodiments, a method for manufacturing an article is provided, comprising the following steps:

a) preparation of the bioceramic solution;

b) applying the solution to the product;

however, when heated or exposed to heat, the bioceramic provides a biomodulatory or physiological effect when the product is applied to the subject.

In other or additional embodiments, a method for making an article is provided wherein the solution is applied to the article using spray techniques on the inside or outside of the article. In some embodiments, the solution is applied to the article by a screen printing method, a dot method, a bonding solution method, a visually repeating pattern approach, or any other suitable method, to the inside or outside of the article, optionally using a dye. In other or additional embodiments, no ink is used in the method. In some embodiments, the solution is applied to the article by dipping or dipping the article into the suspension or solution. In specific embodiments, the implementation of the bioceramic solution contains a polymer. In some embodiments, the implementation of the polymer includes a silicone polymer. In other or additional embodiments, the implementation of the solution is applied to the inner surface of the product, the outer surface of the product or a specific area of the product. In one embodiment, the solution is applied to the product in the form of small dots.

For example, in some embodiments, the implementation of the bioceramic composition contains:

a) about 20 to 80 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ );

b) about 1 to 30% tourmaline by weight;

c) about 1 to 40 wt.% alumina (Al ₂ O ₃ );

d) about 1 to 40 wt.% silicon dioxide (SiO ₂ );

e) about 1 to 20 wt.% zirconium oxide (ZrO ₂ );

the quantities are presented based on the total weight of the bioceramic composition.

In other or additional embodiments, a bioceramic composition is provided, comprising:

a) about 40 to 60 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ );

b) about 5 to 15% tourmaline by weight;

c) about 15 to 25 wt.% alumina (Al ₂ O ₃ );

d) about 10 to 20 wt.% silicon dioxide (SiO ₂ );

e) about 1 to 20 wt.% zirconium oxide (ZrO ₂ );

the quantities are presented based on the total weight of the bioceramic composition.

In some embodiments, the implementation of the bioceramic composition contains kaolinite in an amount of about 45 to 55 wt.%. In other or additional embodiments, the implementation provides a bioceramic composition that contains kaolinite in an amount of from about 47 to 53 wt.%. In other or additional embodiments, the implementation provides a bioceramic composition that contains kaolinite in an amount of from about 48 to 52 wt.%.

- 18 041903

In some embodiments, a bioceramic composition is provided that contains:

a) about 50 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ );

b) about 10 wt.% tourmaline;

c) about 18 wt.% alumina (Al2O ₃ );

d) about 14 wt.% silicon dioxide (SiO2);

e) about 8% by weight of zirconium oxide (ZrO2).

In some embodiments, the implementation of the bioceramic composition contains tourmaline, which is Na ²⁺ ₃ Al ₆ Si ₆ O ₁₈ (BO ₃ )(OH) ₃ OH.

In some embodiments, the article is a body-worn item selected from T-shirts, trousers, shorts, dresses, skirts, jackets, hats, underwear, socks, caps, gloves, scarves, diapers, and the like. In yet another embodiment, the article is a piece of jewelry selected from bracelets, chains, earrings, medallions, pendants, rings, and the like. In yet another embodiment, the article is a bedding selected from duvets, sheets, pillows, pillowcases, bedspreads, duvet covers, elasticated mattress covers, mattress toppers, and the like. In another embodiment, the article is a body support selected from knee pads, elbow pads, arm compression sleeves, leg compression sleeves, boxing wraps, and the like.

In other or additional embodiments, an article is provided that contains a bioceramic composition, or an article to which a bioceramic composition is applied, the article being selected from the group consisting of body wear, jewelry, patches, pads, insoles, bedding, body supports, roller skates, lotions, soaps, tape, glassware, furniture, paints, inks, stickers, carpets, mats, food and/or drink containers, covers for beverage containers, headbands, shoes, headphones and their combinations. In other or additional embodiments, the article includes an article to be worn on the body, such as clothing. In some embodiments, the body-worn article includes a T-shirt, jacket, shorts, or trousers. In still other embodiments, the body-worn article includes a wrist band, pad, knee brace, ankle brace, sleeve, or patch.

Optionally, the products further include one or more additional frequencies imprinted on the product 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. 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, etc.). Typically, frequency generators produce selected frequencies, which are then transmitted over a connecting cable to a commercially available Frequency Imprinting Plate (eg SP9 or SP12 Vortex Frequency Imprinting Plates). In one embodiment, the frequency or frequencies range from about 0.05 Hz to 20 MHz. In another embodiment, the frequency or frequencies vary in the range of about 5 Hz to 5 MHz. In another embodiment, the frequency or frequencies vary from about 100 Hz to 0.1 MHz. In yet another embodiment, the frequency or frequencies vary in the range of about 1 to 10 kHz. The article to be imprinted with the selected frequency or frequencies is exposed to the frequency emitted by the generator. To accomplish this, the article is placed on the imprinting plate and subjected to a signal of the selected frequency or frequencies to be imprinted. In one embodiment, the imprinting process takes about 5-10 minutes per cycle depending on the number of frequencies to be imprinted and the selected imprinting program. In another embodiment, the imprinting process takes about 5, 6, 7, 8, 9, or 10 minutes per cycle, depending on the number of frequencies to be imprinted and the selected imprinting program. The imprinted articles can transmit frequency imprints to the user upon contact in combination with the waves emitted by the bioceramic composition that is incorporated into the article.

In some embodiments, the implementation of the method of manufacturing products containing bioceramics according to the invention, includes a approach based on the use of silicone. As a rule, silicones are inert synthetic compounds. A silicone coating is, for example, an ink, paint, oil, film, coating, lubricant or resin that is applied to an article according to the invention by screen printing, spraying or otherwise. In some embodiments, the silicone coating is premixed with the bioceramic prior to application to the body-worn article. In some embodiments, the implementation of the silicone coating is applied over the bioceramic in the form of a film. In some embodiments, the implementation of the silicone is mixed with a bioceramic composition having a certain concentration, while the mixture provides a biomodulatory or physiological effect on the subject. In some embodiments, the silicone is mixed with a bioceramic having a higher concentration than the concentration of the bioceramic that can be effectively mixed with an ink or gel.

- 19 041903

In some embodiments, bioceramics are mixed with silicone at a concentration of up to 50% compared to ink or gel.

In some embodiments, the bioceramic composition of the invention is mixed in a ratio of about 1 part bioceramic to 1 part silicone, about 1 part bioceramic to 2 parts silicone, about 1 part bioceramic to 3 parts silicone, about 1 part bioceramic to 4 parts silicone, about 1 part bioceramic to 5 parts silicone, about 1 part bioceramic to 6 parts silicone, about 1 part bioceramic to 7 parts silicone, about 1 part bioceramic to 8 parts silicone, about 1 part bioceramic to 9 parts silicone, about 1 part bioceramic to 10 parts silicone , about 1 part bioceramic to 11 parts silicone, about 1 part bioceramic to 12 parts silicone, about 1 part bioceramic to 13 parts silicone, about 1 part bioceramic to 14 parts silicone, about 1 part bioceramic to 15 parts silicone, about 1 part bioceramic to 16 parts of silicone, about 1 part of bioceramics to 17 parts of silicone, about 1 part of bioceramics to 18 parts of silicone, about 1 part of bioceramics about 1 part bioceramic to 20 parts silicone, about 1 part bioceramic to 21 parts silicone, about 1 part bioceramic to 22 parts silicone, about 1 part bioceramic to 23 parts silicone, about 1 part bioceramic to 24 parts silicone , about 1 part bioceramic to 25 parts silicone, about 1 part bioceramic to 26 parts silicone, about 1 part bioceramic to 27 parts silicone, about 1 part bioceramic to 28 parts silicone, about 1 part bioceramic to 29 parts silicone, about 1 part bioceramic to 30 parts silicone, about 1 part bioceramic to 31 parts silicone, about 1 part bioceramic to 32 parts silicone, about 1 part bioceramic to 33 parts silicone, about 1 part bioceramic to 34 parts silicone, about 1 part bioceramic to 35 parts silicone or another suitable ratio.

In some embodiments, the bioceramic composition of the invention is mixed in a ratio of about 1 part bioceramic to 1 part silicone, about 2 parts bioceramic to 1 part silicone, about 3 parts bioceramic to 1 part silicone, about 4 parts bioceramic to 1 part silicone, about 5 parts bioceramic to 1 part silicone, about 6 parts bioceramic to 1 part silicone, about 7 parts bioceramic to 1 part silicone, about 8 parts bioceramic to 1 part silicone, about 9 parts bioceramic to 1 part silicone, about 10 parts bioceramic to 1 part silicone , about 11 parts bioceramic to 1 part silicone, about 12 parts bioceramic to 1 part silicone, about 13 parts bioceramic to 1 part silicone, about 14 parts bioceramic to 1 part silicone, about 15 parts bioceramic to 1 part silicone, about 16 parts bioceramic for 1 part of silicone, about 17 parts of bioceramics for 1 part of silicone, about 18 parts of bioceramics for 1 part of silicone, about 19 parts of bioceramics about 20 parts of bioceramic to 1 part of silicone, about 25 parts of bioceramic to 1 part of silicone, about 26 parts of bioceramic to 1 part of silicone, about 27 parts of bioceramic to 1 part of silicone, about 28 parts of bioceramic to 1 part of silicone , about 29 parts bioceramic to 1 part silicone, about 30 parts bioceramic to 1 part silicone, about 31 parts bioceramic to 1 part silicone, about 32 parts bioceramic to 1 part silicone, about 33 parts bioceramic to 1 part silicone, about 34 parts bioceramic to 1 part of silicone, about 35 parts of bioceramics to 1 part of silicone or other suitable ratio.

In other embodiments, the implementation of the method of manufacturing products containing bioceramics according to the invention, includes the approach based on the dot application. In a dot-based manufacturing method, a dot containing the bioceramic, alone or in combination with a matrix, is applied to the product. In some embodiments, the matrix is, for example, a silicone matrix, a polymer matrix, or a gel matrix. In some embodiments, the polymer matrix is a non-toxic bioceramic holder. In some embodiments, the implementation of the polymer matrix has an active function in relation to determining the amount of infrared energy that is reflected by the bioceramic. In some embodiments, the implementation of the polymer matrix is adhesive. In some embodiments, the polymer is used to bond the bioceramic composition to the fabric.

Various polymers can be mixed with the bioceramics of the invention and applied to the product, including, for example, silicone, hydrogels such as cross-linked polyvinyl alcohol and polyhydroxyethyl methacrylate, acyl-substituted cellulose acetates and their alkyl derivatives, and fully hydrolyzed alkylene-vinyl acetate copolymers, unplasticized polyvinyl chloride , crosslinked polyvinyl acetate homo- and copolymers, crosslinked acrylic acid and/or methacrylic acid polyesters, polyvinyl alkyl ethers, polyvinyl fluoride, polycarbonate, polyurethane, polyamide, polysulfones, styrene-acrylonitrile copolymers, crosslinked polyethylene oxide, polyalkylenes, polyvinylimidazole, polyesters, polyethylene terephthalate, polyphosphazenes and chlorosulfonated polyolefins, and combinations thereof. In some embodiments, the implementation of the polymer contains ethylene vinyl acetate.

In some embodiments, the implementation of the method of manufacturing products containing bioceramics according to the invention, includes the approach based on the application of a binder or solution. In some embodiments, the bioceramic composition is sprayed over or wetted onto an article, such as a T-shirt, pad, or bandage. In some embodiments, the implementation of the binder is a film-forming component of the bioceramic paint. In some cases, the binder contains materials that allow the bioceramic to adhere to the body-worn article and have a significant effect on properties such as gloss, strength, flexibility, and resilience of the applied bioceramic. In some cases, the binder includes synthetic or natural resins such as alkyls, acrylics, vinylacryls, vinyl acetate/ethylene (VAE), polyurethanes, polyesters, melamine resins, epoxy or oils.

Other non-erodible materials suitable for inclusion in a bioceramic body wear article include, for example, proteins such as zein, resilin, collagen, gelatin, casein, silk, wool, polyesters, polyorthoesters, polyphosphoesters, polycarbonates, polyanhydrides, polyphosphazenes, polyoxalates, polyamino acids, polyhydroxyalkanoates, polyethylene glycol, polyvinyl acetate, polyhydroxy acids, polyanhydrides, hydrogels, including polyhydroxyethyl methyl acrylate, polyethylene glycol, poly-P-isopropylacrylamide, poly-P-vinyl-2-pyrrolidone, polyvinyl alcohol/cellulose, silicone hydrogels, polyacrylamides and polyacrylic acid.

In some embodiments, the implementation of the method of manufacturing products containing bioceramics according to the invention, is a process of visual repetition of the pattern. The method for visually repeating patterns often includes a first step in which the pattern is applied to the body-worn article by printing, screen printing, spraying, or otherwise using conventional inks (without bioceramics). The method of visually repeating patterns often includes a second step in which application is carried out by spraying a second material, such as silicone or a binder base containing bioceramics, over the first pattern. Any of the above materials can be used in the visual patterning method, including silicones, adhesives, and polymers.

The manufacturing method described herein is used to apply a bioceramic to a specific location on a body-worn article or to the entire body-worn article. For example, the manufacturing method disclosed herein can be used to apply the bioceramic to the inside surface, the outside surface, or any combination of the inside/outside surface of a body wear item. In most embodiments, application of the bioceramic to the inner surface, outer surface, or inner/outer surface combination of the body wear does not affect the biomodulatory or physiological effect of the bioceramic.

In some embodiments, the item contains about 5% bioceramic by weight,

about 10% bioceramics from the total mass about 15% bioceramics of the total mass about 20% bioceramics from total mass, about 25% bioceramics of the total mass, about 30% bioceramics from total mass, about 35% bioceramics of the total mass, about 40% bioceramics from total mass, about 45% bioceramics of the total mass, about 50% bioceramics from total mass, about 55% bioceramics of the total mass, about 60% bioceramics from total mass, about 65% bioceramics of the total mass, about 70% bioceramics from total mass, about 75% bioceramics of the total mass, about 80% bioceramics from total mass, about 85% bioceramics of the total mass, about 90%

bioceramics of the total mass or about 95% of bioceramics of the total mass.

In some embodiments, the implementation of the bioceramic is applied to part or all of the surface of the object to be worn on the body. In some cases, the bioceramic composition is applied to more than 1%

from area surface, more how 10% from area surface, more how 15% from area surface, more how 20% from area surface, more how 25% from area surface, more how thirty% from area surface, more how 35% from area surface, more how 40% from area surface, more how 45% from area surface, more how 50% from area surface, more how 55% from area surface, more how 60% from area surface, more how 65% from area surface, more how 70% from area surface, more how 75% from area surface, more how 80% from area surface, more how 85% from area surface, more how 90% from area surface, more how 95% from the surface area or more than 99% of the surface area of the body-worn item. In some cases, bioceramic composition applied to not more how 1% from area surface, no more how 5% from area surfaces, not more how 10% from area surface, no more how 15% from area surfaces, not more how 20% from area surface, no more how 25% from area surfaces, not more how thirty% from area surface, no more how 35% from area surfaces, not more how 40% from area surface, no more how 45% from area surfaces, not more how 50% from area surface, no more how 55% from area surfaces, not more how 60% from area surface, no more how 65% from area surfaces, not more how 70%

- 21 041903

from area surfaces, not more how 75% from area surfaces, not more how 80% from area surfaces, not more how 85% from area surfaces, not more how 90% of the surface area, not more than 95% of the surface area, or not more than the surface area of the item to be worn on the body. how 99% In some cases, bioceramic the composition is applied near on 1% from area surface, near on 2% from area surface, near on 3% from area surface, near on 4% from area surface, near on 5% from area surface, near on 6% from area surface, near on 7% from area surface, near on 8% from area surface, near on 9% from area surface, near on 10% from area surface, near on eleven% from area surface, near on 12% from area surface, near on 13% from area surface, near on 14% from area surface, near on 15% from area surface, near on 16% from area surface, near on 17% from area surface, near on 18% from area surface, near on 19% from area surface, near on 20% from area surface, near on 21% from area surface, near on 22% from area surface, near on 23% from area surface, near on 24% from area surface, near on 25% from area surface, near on 26% from area surface, near on 27% from area surface, near on 28% from area surface, near on 29% from area surface, near on thirty% from area surface, near on 31% from area surface, near on 32% from area surface, near on 33% from area surface, near on 34% from area surface, near on 35% from area surface, near on 36% from area surface, near on 37% from area surface, near on 38% from area surface, near on 39% from area surface, near on 40% from area surface, near on 41% from area surface, near on 42% from area surface, near on 43% from area surface, near on 44% from area surface, near on 45% from area surface, near on 46% from area surface, near on 47% from area surface, near on 48% from area surface, near on 49% from area surface, near on 50% from area surface, near on 51% from area surface, near on 52% from area surface, near on 53% from area surface, near on 54% from area surface, near on 55% from area surface, near on 56% from area surface, near on 57% from area surface, near on 58% from area surface, near on 59% from area surface, near on 60% from area surface, near on 61% from area surface, near on 62% from area surface, near on 63% from area surface, near on 64% from area surface, near on 65% from area surface, near on 66% from area surface, near on 67% from area surface, near on 68% from area surface, near on 69% from area surface, near on 70% from area surface, near on 71% from area surface, near on 72% from area surface, near on 73% from area surface, near on 74% from area surface, near on 75% from area surface, near on 76% from area surface, near on 77% from area surface, near on 78% from area surface, near on 79% from area surface, near on 80% from area surface, near on 81% from area surface, near on 82% from area surface, near on 83% from area surface, near on 84% from area surface, near on 85% from area surface, near on 86% from area surface, near on 87% from area surface, near on 88% from area surface, near on 89% from area surface, near on 90% from area surface, near on 91% from area surface, near on 92% from area surface, near on 93% from area surface, near on 94% from area surface, near on 95% from area surface, near on 96% from area surface, near on 97% from area surface, near on 98% from area surface, near on 99%

from the surface area, about 100% of the surface area of the object to be worn on the body.

Application in cosmetics

In some aspects, the present invention relates to a cosmetic composition containing a composite powder, foam, liquid, oil, wax, base or emulsifying agent that contains a far infrared emitting bioceramic. Cosmetic compositions according to the invention may contain an effective amount of bioceramics in various cosmetic carriers such as cosmetic lotion, cream, powder, mask, gel patch and general cosmetics. The cosmetic composition according to the invention may contain various proportions

- 22 041903 solutions for ceramics and cosmetic carriers. For example, a composition according to the invention may contain 1 part bioceramic to 1 part cosmetic carrier, 1 part bioceramic to 2 parts cosmetic carrier, 1 part bioceramic to 3 parts cosmetic carrier, 1 part bioceramic to 4 parts cosmetic carrier, 1 part bioceramic to 5 parts cosmetic carrier. carrier, 1 part bioceramic per 6 parts cosmetic carrier, 1 part bioceramic per 7 parts cosmetic carrier, 1 part bioceramic per 8 parts cosmetic carrier, 1 part bioceramic per 9 parts cosmetic carrier, 1 part bioceramic per 10 parts cosmetic carrier, 1 part bioceramic 1 part bioceramic per 12 parts cosmetic carrier, 1 part bioceramic per 13 parts cosmetic carrier, 1 part bioceramic per 14 parts cosmetic carrier, 1 part bioceramic per 15 parts cosmetic carrier, 1 part bioceramic per 16 parts cosmetic carrier , 1 part of bioceramics for 17 hours parts of cosmetic carrier, 1 part bioceramic per 18 parts cosmetic carrier, 1 part bioceramic per 19 parts cosmetic carrier, 1 part bioceramic per 20 parts cosmetic carrier, 1 part bioceramic per 21 parts cosmetic carrier, 1 part bioceramic per 22 parts cosmetic carrier, 1 part bioceramic per 23 parts cosmetic carrier, 1 part bioceramic per 24 parts cosmetic carrier, 1 part bioceramic per 25 parts cosmetic carrier, 1 part bioceramic per 26 parts cosmetic carrier, 1 part bioceramic per 27 parts cosmetic carrier, 1 part bioceramic per 28 parts cosmetic carrier, 1 part bioceramic to 29 parts cosmetic carrier, 1 part bioceramic to 30 parts cosmetic carrier, or other suitable ratio. In some cases, the bioceramic composition according to the invention can be applied directly to the skin.

Another aspect of the subject matter described herein are cosmetic compositions, and in particular cosmetic compositions for the reduction of expression lines, scars, skin blemishes, and for the reduction/control of puffiness around the eyes. A cosmetic composition effective for reducing expression lines, scars, reddening spots on the skin, as well as for reducing/controlling puffiness around the eyes, can be obtained by adding bioceramics to a cosmetic composition such as lotion, cream, powder, mask, gel patch, oil , foundation, wax, emulsifying agents or general cosmetic powders in various colors. The cosmetic compositions provide a beneficial biomodulatory effect by providing far infrared radiation energy that reduces expression lines on the skin, puffiness around the eyes and blemishes, thereby making the lines on the skin less noticeable.

The composition according to the invention can be applied to various types of skin. Skin types include normal, oily, dry, sensitive and combination skin types. Some people also have combination skin types on different areas of the skin. The composition according to the invention can be applied to skin types that differ in a) water content, which affects the comfort and elasticity of the skin; b) the fat (lipid) content, which can affect the softness of the skin; and c) the level of sensitivity. The cosmetic composition according to the invention can provide beneficial far infrared radiation for various skin types. For example, when exposed to factors that cause dryness, the skin can crack, peel, or become itchy, irritated, or inflamed. The cosmetic composition according to the invention can help reduce itching, irritation, sensitivity or inflammation.

The composition according to the invention can be applied directly or indirectly to the skin. For example, a far infrared emitting bioceramic may be contained within an eye mask and the subject may wear said eye mask to reduce eye puffiness. The far infrared emitting bioceramic can be administered topically and can be contained in various topical formulations such as solutions, suspensions, lotions, gels, pastes, medicated sticks, balms, creams and ointments. Such pharmaceutical compositions may contain solubilizing agents, stabilizing agents, tonicity agents, buffers and preservatives.

The far infrared emitting bioceramic can be formulated as an oil or an emulsion. Suitable lipophilic solvents or carriers that can be formulated with the bioceramics described herein 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 that increase the viscosity of the suspension, such as sodium carboxymethyl cellulose, sorbitol or dextran. The suspension may also contain suitable stabilizing agents or agents which increase the solubility of the compounds to enable highly concentrated solutions to be obtained. Alternatively, the active bioceramic ingredient may be presented in powder form for reconstitution with a suitable vehicle, eg sterile, pyrogen-free water, prior to use.

In some cases, transdermal patches can provide controlled delivery of far infrared radiation energy to a subject. For example, the rate of absorption of radiation in the far infrared can be slowed down by using con

- 23 041903 rate controlling membranes or by encapsulating the compound in a polymer matrix or gel. On the contrary, absorption enhancers can be used to increase the absorption of radiation energy in the far infrared region. The absorption enhancer or carrier may include absorbent pharmaceutically acceptable diluents to facilitate skin passage. For example, transdermal devices may be in the form of a dressing comprising a liner, a reservoir containing compounds and carriers, a rate-controlling barrier to deliver compounds to a subject's skin at a controlled and predetermined rate over an extended period of time, and adhesives to hold the device. on the skin.

Typically, the coloring agent and/or resin can be used in conjunction with the bioceramic composition in cosmetic applications. A variety of coloring agents and resins, including inorganic and organic dyes or pigments, can be used to make and color cosmetics. Polymeric materials approved by the Food and Drug Administration as Indirect Food Additives can be used as resins for use in cosmetic compositions containing bioceramics. Non-limiting examples of polymeric materials that can be used as resins in cosmetic formulations include acrylic and modified acrylic plastics; acrylonitrile/butadiene/styrene copolymers; acrylonitrile/butadiene/styrene/methyl methacrylate copolymers; acrylonitrile/styrene copolymers; acrylonitrile/styrene copolymers modified with styrene-butadiene elatomer; cellophane; copolymers of cyclohexylene-dimethylene-terephthalate and 1,4-cyclohexylenedimethylene-isophthalate; copolymers of ethylene and acrylic acid; ethylene 1,4 cyclohexylene dimethylene terephthalate copolymers; ethylene-ethyl acrylate copolymers; ionomer resins; ethylene-methyl acrylate copolymer resins; ethylene-vinyl acetate copolymers; ethylene-vinyl acetate-vinyl alcohol copolymers; fluoropolymers; a water-soluble film based on hydroxyethyl cellulose; isobutylene polymers; isobutylene-butene copolymers; 4,4'-isopropylidene diphenol epichlorohydrin resins; melamine-formaldehyde resins; nitrile rubber, modified arylonitrile-methyl arylate copolymers; polyamide resins; olefin polymers; perfluorocarbon resins; polyacrylate resins; polyarylsulfone resins; poly-1-butene resins and butene/ethylene copolymers; polycarbonate resins; elastomers based on polyesters; polyesterimide resins; carboxyl-modified polyethylene resins; chlorinated polyethylene; fluorinated polyethylene; oxidized polyethylene; polyethylene phthalate polymers; poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene); polystyrene and rubber-modified polystyrene; polysulfide polymer-polyepoxy resins; polysulfone resins; poly(tetramethylene terephthalate); films based on polyvinyl alcohol; polyurethane resins; styrene block copolymers; copolymers of styrene with maleic anhydride; copolymers of styrene with methyl methacrylate; textiles; urea-formaldehyde resins; vinyl chloride-ethylene copolymers; copolymers of vinyl chloride and hexene-1; vinyl chloride-lauryl vinyl ether copolymers; vinyl chloride-propylene copolymers; vinylidene chloride/methyl acrylate copolymers; polymers based on vinylidene chloride/methyl acrylate/methyl methacrylate; chlorosulfonated ethylene polymers; thermoset epoxy resins based on 4,4'-isopropylidenediphenol-epichlorohydrin; polyamide resins with mineral filler; cured perfluorocarbon elatomers; phenolic resins; polyester resins, crosslinked; polyester resins, chlorinated; polyethersulfone resins; polyamideimide resins; poly(2,6-dimethyl-1,4-phenylene) oxide resins; polyoxymethylene copolymers; polyoxymethylene homopolymers; polyphenylene sulfide resins; polyvinylidene fluoride resins; and styrene-divinylbenzene resins, cross-linked.

A method of making cosmetic compositions containing a far infrared emitting bioceramic described herein involves formulating compounds with one or more inert, pharmaceutically acceptable excipients or carriers to form a solid, semi-solid composition in the form of a foam, wax, cream, lotion, or liquid. compositions.

These compositions may also contain minor amounts of non-toxic excipients such as wetting or emulsifying agents, pH buffering agents and other pharmaceutically acceptable additives.

Patterns.

Bioceramics can be added to a product in a variety of regular or irregular patterns. The bioceramic pattern may cover the entire surface of the body-worn article, or the pattern may cover a portion of the body-worn article. The bioceramic pattern covering the object may have areas of discontinuity having various shapes and sizes. For example, the pattern may be a honeycomb pattern (for example, with hexagonal discontinuities), a grid pattern (for example, with square or rectangular discontinuities), a random pattern (for example, with non-uniformly distributed discontinuities), and so on. .d. Typically, areas of discontinuity

- 24 041903 can be spread over the surface at regular or irregular intervals. The areas of discontinuity may have a variety of regular or irregular shapes, such as, for example, round, semicircular, diamond-shaped, hexagonal, multilobal, octagonal, oval, pentagonal, rectangular, square, star-shaped, trapezoidal, triangular, wedge-shaped, etc. Optionally, one or more areas of discontinuity can be formed in the form of logos, letters or numbers. In some embodiments of the present invention, discontinuity regions may have dimensions of about 0.1, about 1, about 2, about 3, 4, about 5, about 6, 7, about 8, about 9, about 10 mm, or other desired distance.

In some embodiments, the areas of discontinuity may vary from 0.1 to about 1 mm, from 1 to about 5 mm, from 1 to about 10 mm, from 1 to about 15 mm, from 1 to about 20 mm, from 1 to about 25 mm, 1 to about 30 mm, or other desired spacing.

Typically, discontinuities may be the same or different shapes or sizes.

The bioceramic pattern may be applied as a coating covering the inside and/or outside surface of the body-worn article. The bioceramic pattern may be imbibed into a material such as fabric. The bioceramic pattern may cover various parts of the tissue in a continuous, discontinuous, regular or irregular pattern, or any combination thereof. Bioceramic pattern can impregnate 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 75%, less than 80%, less than 85%, less than 90%, less than 95%, or less than 99% of the inner surface of the body-worn article, the outer surface of the body-worn article, or any combination thereof.

The following non-limiting examples serve to further illustrate the present invention.

Examples

Example 1. Production of a bioceramic powder composition.

Kaolinite is mined in the vicinity of Parintins, Amazonas, Brazil. The city is located in the Amazonas region (coordinates: latitude: 2°37'42 S/longitude: 56°44'11 west of Greenwich, 50 m above sea level). Alternatively, kaolinite is purchased from a mining company/supplier.

The recovered kaolinite is washed with hydrogen peroxide (H ₂ O ₂ ) and allowed to dry. The dried kaolinite is then finely ground and mixed with tourmaline; aluminum oxide (Al ₂ O ₃ ); silicon dioxide (SiO ₂ ) and zirconium oxide (ZrO ₂ ) until a homogeneous mixture is obtained. The resulting bioceramic composition contains 50 wt.% kaolinite, 10 wt.% tourmaline, 18 wt.% alumina, 14 wt.% silicon dioxide and 8 wt.% zirconium oxide.

The bioceramic composition can also be synthesized. The resulting bioceramic contains any of the compositions described herein, including about 50% kaolinite, about 10% tourmaline, about 18% alumina, about 14% silica, and about 8% zirconia.

Example 2 Application to clothing.

The bioceramic according to the invention is a refractory, inorganic, polycrystalline composition that can be reduced to powder form by grinding, crushing or other suitable method. In powder form, bioceramics are incorporated into a range of materials; including various types of resins and inks. The bioceramic in powder form is introduced into a fabric substrate to apply the ink containing the bioceramic to the fabric.

Received a fabric substrate containing 88 wt.% polyamide and 12 wt.% elastane. Bioceramic composition obtained in accordance with the method in example 1 was introduced into plastisol ink in the amount of 10-50 wt.% and mixed. The mixture was applied to a fabric substrate using a standard screen printing process. The specific type of ink was chosen based on the selected fabric.

Example 3 Application of bioceramics to clothing (eg T-shirt) by screen printing.

Concentration: Ceramic materials were mixed with ink at a concentration of 30% of the total weight/volume.

Mixing process: The ceramics were gradually added to the ink. The continuous mixing process was carried out using a mixer, which is usually used for mixing pigments and inks. The materials were mixed until a homogeneous and evenly distributed mixture/suspension was obtained. The process was fast because the ceramic mixes well with different types of inks.

Slurry/Mixture Life: A well-sealed mixture can be stored and used within one week of manufacture.

Application: The bioceramic material is applied in the same way as conventional ink through a screen printing process. Due to the particle size, it has been observed that bioceramic materials can scratch screens. It is recommended to check/inspect the screens every 1000 T-shirts and, if

- 25 041903 necessary, their replacement, in particular in order to avoid defects in the application and appearance of the logo.

Fabric Choice: The ceramic did not cause any visible damage to the fabric. It has been observed that the use of fabrics that are too porous or cannot be subjected to the normal drying process commonly used in screen printing should be avoided.

Ink selection: Ceramics can increase ink density and the type of ink should be selected by one skilled in the art based on the type of fabric being used.

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 chosen. After a first experiment using the selected fabric and ink, the product should be subjected to a wash test to ensure that the ink does not bleed or crack.

The screen printing process is used to provide the body-worn article with ceramics in the desired pattern. The screen printing approach is used to imprint a pattern on a T-shirt. In FIG. 1 shows a T-shirt containing a ceramic composition according to the invention, which is produced using screen printing.

Example 4 Approach using dot application of bioceramics to clothing (eg T-shirt).

Concentration: The ceramic material is mixed with silicone or a polymer such as gel in a ratio of 1 part ceramic to 9 parts silicone. Alternatively, the ceramic materials are mixed with a polymer such as m-gel in a ratio of 1 part ceramic to 9 parts m-gel.

Application: The device was used to apply ceramic dots to the fabric with the desired pattern. The spot application approach is used, for example, to imprint a pattern on a T-shirt. In FIG. 1 shows a T-shirt containing a ceramic composition according to the invention.

Fabric Choice: Ceramic does not cause any observable tissue damage. The spot application approach is used to apply bioceramics to specific areas of tissue or body wear. In some cases, the spot application approach is used to apply the ceramic to specific areas, even to the top of the stencil, to achieve a higher concentration of ceramic per surface area. The spot application approach is applied around the shoulders, elbows, or any area where a higher concentration of ceramic is desired.

Example 5 Binder/solution approach for applying bioceramics to clothing (eg T-shirt).

Concentration: As an alternative to mixing the ceramic with the ink and using screen printing and dot-based approaches to apply the ceramic to the fabric, a binder solution approach was used. The binder solution or suspension contains up to 50% ceramic and up to 50% binder solution.

Application: The fabric was placed in a suspension solution containing ceramic and binder at the desired concentration. The fabric was removed from the suspension solution and left to dry. The fabric has now been impregnated or infused with the ceramic of the invention. The tissue that had been impregnated or infused with the ceramic was directly brought into contact with the subject's skin.

Example 6 Approach using visual repetition of a pattern for applying bioceramics to clothing (eg a T-shirt).

Concentration: Prepared the first solution containing the ink. A second solution, slurry or binder containing about 10 to 50% ceramic was prepared by mixing the ceramic of the invention with the ink, slurry or binder.

Application: The first pattern was applied to the fabric by spraying, screen printing or otherwise. The first pattern consists of ink and does not contain bioceramic material. A second pattern containing about 10 to 50% ceramic was then applied to the first pattern by spraying, screen printing, or otherwise. A silicone coating may be applied over the second pattern to provide a glossy finish to the pattern applied to the fabric. The silicone coating can be mixed with the ceramic prior to application at a certain concentration.

Example 7. Making a pillow.

Thermoplastic elastomer (TPE) was liquefied with the bioceramic of the invention. TPE and ceramic were 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 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. The liquid mixture was placed in a matrix. The mixture containing TPE and bioceramics was left to cure, after which a matrix-shaped object was obtained. The item was removed from the matrix. The item is a thermoplastic pad containing bioceramic, such as the pad shown in FIG. 3.

- 26 041903

Example 8 Use of bioceramics as anti-inflammatory agents and for modulating cytokine levels.

Laboratory mice were injected with the bioceramic composition according to Example 1. On day 5 after CFA injection (following 5 consecutive bioceramic treatments), the mice's right hind paw was cut off and used to assess cytokine levels by enzyme-linked immunosorbent assay (ELISA), with data obtained from sample analysis , corrected for protein levels. The following cytokines can be evaluated, individually or as a group: TNF-α, IL-1e, IL-10 and IL-6. The uptake intensity for the above cytokines can be measured using a microplate reader at 450 and 550 nm. The level of cytokines in mice can be determined to confirm the anti-inflammatory effect of bioceramic compositions.

Example 9 Determination of levels of oxidative stress and antioxidant enzymes.

Laboratory mice were injected with a bioceramic composition according to example 1.

On day 5 after CFA injection, tissues from the right hind legs (skin and muscle) of mice were harvested and used to evaluate oxidative damage. For this test, the formation of reactive particles of thiobarbituric acid (TBARS) was measured during reaction with acid on heating. The samples were mixed with 1 ml of 10% trichloroacetic acid (TCA) and 1 ml of 0.67% thiobarbituric acid and then heated in a boiling water bath for 15 minutes. TBARS levels were determined from the absorption intensity at a wavelength of 535 nm. Results are expressed as malondialdehyde (MDA) equivalents (nmol/mg protein).

Oxidative damage to proteins was measured by quantifying carbonyl groups based on the reaction with dinitrophenylhydrazine (DNPH) described previously. Proteins were precipitated by adding 20% trichloroacetic acid and optionally redissolved in DNPH; absorbance was read at a wavelength of 370 nm. Results may be reported as nmol carbonyl content per mg protein (nmol/mg protein), or results may be reported using another suitable unit of measure.

To determine catalase (CAT) activity, paw tissues were sonicated in 50 mmol/l phosphate buffer (pH 7.0) and the resulting suspension was centrifuged at 3000xg for 10 min. The supernatant was used for enzyme analysis. Measurement of catalase activity (CAT) was performed by the rate of decrease in the absorption of hydrogen peroxide at 240 nm. Results are presented as U/mg protein or any other suitable unit of measure.

Superoxide dimutase (SOD) activity was assessed by measuring inhibition of adrenaline autoxidation as described previously. All biochemical parameters were normalized to protein content using bovine albumin as a standard. All results were normalized to protein concentration as measured by the Lowry assay. Results are presented as (U/mg protein) or any other suitable unit.

Example 10 Effect of Far Infrared Radiation Emitted from Bioceramics on Physical Performance Parameters in Mice.

Objective: To evaluate the effect of far infrared radiation therapy emitted by bioceramics on physical performance parameters in mice subjected to a swimming protocol.

Methods: Experiments were performed using male Swiss mice (30-35 g) after approval by the University of South of Santa Catarina Ethics Committee. Mice were randomized into 2 groups and subjected to a 30 min swimming protocol for 21 days. For treatment, a bioceramic pad containing the composition described in Example 1 (80% BioCorn PVC - 20% bioceramic material) was placed in animal boxes for three weeks. Control animals were placed on a sham pad (100% BioCorn PVC without bioceramics) and subjected to this experimental protocol. At the end of each week, body weight and volume of food and water intake were measured and an endurance test was performed in which mice were made to swim to exhaustion with a weight of 5% of their body weight tied to their tails. The point of exhaustion was considered to be the moment when the animal could not keep its head above the water for more than 5 s. At the end of the third week, the grip strength of the right hind leg was tested using a feedback system with a tensiometer, and the weight of the gastrocnemius muscle was measured using an analytical scale.

Results: Far infrared radiation emitted from the bioceramic pad containing the composition of Example 1 increased the time to point of exhaustion in the forced swim test (133.1%, 60.4%, and 90.83% in weeks 1 to 3) but had no effect on body weight, water and food intake. Although the weight of the gastrocnemius muscle did not change, the bioceramic according to example 1 increased the grip strength of the hind leg by 6.6%.

Conclusion: Far infrared radiation therapy emitted by the bioceramics of Example 1 increased hindlimb grip strength and time to point of exhaustion in mice subjected to a three week swimming protocol. These results indicate an increase in resistance, muscle endurance and overall endurance (energy levels).

- 27 041903

Example 11 Far infrared radiation therapy emitted by bioceramics improves postural swing in athletes.

Purpose of the study: The purpose of this study was to evaluate the effect of far infrared radiation therapy emitted by bioceramics on the orthostatic balance of judokas of the University of Brazil team in a double-blind, controlled study.

Methods: A total of 17 athletes (7 women and 10 men; aged 23±4.75 years) from the University of South of Santa Catarina (UNISUL) wore a bioceramic t-shirt containing the composition of Example 1 (a t-shirt with a screen printed bioceramic) or an imitation T-shirt (without bioceramics) during practice (for 2 hours, 5 times a week for 5 months). The judokas belonged to seven different weight categories and were evenly divided into two experimental groups (bio-ceramic or imitation T-shirts) in such a way that each group had approximately the same number of athletes from each weight category. Center of pressure (CoP) parameters (length, range of motion, anterior-posterior and mid-lateral speed) were measured in three 30-s tasks of a static two-legged stance—athletes were asked to keep their eyes open and stand with a narrow stance on the Balance Platform (T-Plate Balance Platform, Medicapteurs, France). Assessments were made before and after 5 months of bioceramic T-shirts.

Results: The results obtained showed statistically significant reductions (p<0.05) in all assessed CoP parameters (length, swing area, AP and mid-lateral speed) in the group of athletes who wore the bioceramic T-shirt compared to the group who wore an imitation T-shirt.

Conclusion: Far infrared radiation therapy emitted from a bioceramic T-shirt containing the composition according to example 1 had a positive effect on the orthostatic balance of the judo team of the Brazilian University.

Example 12 Far infrared radiation emitted by bioceramics reduces mechanical and thermal hyperalgesia in an animal model of chronic inflammatory pain.

Objective of the study: This study evaluated the effect of far infrared radiation emitted by the bioceramic composition of example 1, injected into the pad, against mechanical and thermal hyperalgesia, as well as increased paw temperature and edema in a mouse model of inflammatory pain.

Methods: Experiments were performed on male Swiss mice (30-35 g) after receiving approval from the University of South of Santa Catarina Ethics Committee. Animals were injected intraplantarly with complete Freund's adjuvant (CFA, 20 μl - 70%) and a bioceramic pad (80% BioCorn PVC - 20% bioceramic material) was placed in animal boxes for treatment. After 24 hours of exposure to the product, mechanical and thermal hyperalgesia was evaluated as response rates per 10 applications of 0.4 g von Frey filament or hot stimuli applied to the right hind paw of the animal (Hot Plate Method). Assessments were made daily for 10 days. After the evaluation, the animals were placed in boxes and re-exposed to the pad until the next evaluation (after 24 hours). In addition, edema formation and hindpaw temperature were assessed on experimental days 1, 3, and 10 with a micrometer and a digital thermometer, respectively. Control mice were placed on a sham pad (100% BioCorn PVC without bioceramics) and subjected to the same experimental protocol.

Results: Acute exposure to the bioceramic pad produced analgesia that lasted for 2 hours (P<0.001 - maximum inhibition was 53±11%). Long-term treatment caused a decrease in mechanical hyperalgesia on all assessment days and thermal hyperalgesia on days 1 and 3. In addition, treatment caused a decrease in paw temperature on days 1 and 3.8±1% (P<0.001) and 5±1% (P <0.05), but did not affect the formation of edema.

Conclusion: Far-infrared radiation emitted by the bioceramic pad reduced mechanical and thermal hyperalgesia of inflammatory origin, as well as increased paw temperature, induced by CFA intraplantar injection in mice.

Example 13 Randomized, double-blind, placebo-controlled study of the University Division I hockey team to assess fitness parameters.

Objective: To evaluate the effect of the bioceramic printed training uniform on lung tidal volume, back and leg muscle strength, and cardiorespiratory endurance.

Study design: Randomized, double-blind, placebo-controlled study of 30 healthy ice hockey players. Each participant was randomized by manual draw (pulling a match or a piece of paper out of the bag) to wear a training uniform containing the bioceramic composition according to Example 1 or a simulated training uniform during daily training, and a bioceramic or simulated bandage throughout the day. Evaluations were performed in both groups once a week for 4 consecutive weeks on predetermined days prior to the start of daily training.

Testing methodology and results.

(a) Tidal volume of the lungs.

The tidal volume of the lungs was assessed using a spirometer (model SP-10). The parameters assessed were forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF). Forced vital capacity (FVC) is the volume of air forcefully exhaled after the deepest possible breath, measured in liters. FVC is the most important technique in spirometry studies.

FEV1 is the volume of air exhaled during the first second of forced exhalation. Peak expiratory flow (PEF) is the maximum flow (or rate) achieved during a maximally forced exhalation starting from a full inspiration, measured in liters per minute.

(b) Strength of back and leg muscles.

A back/leg dynamometer (Baseline, United States) was used to measure leg and back muscle strength. Using a pronated grip, the participant held the handle of the device and slowly extended their legs to their maximum level.

(c) Cardiorespiratory endurance.

Cardiorespiratory endurance was assessed by a standard 3-minute exercise test (pre-determined in collaboration with the team coach). The cardiorespiratory endurance score was derived from the recovery of normal heart rate after testing by the following formula: cardiorespiratory endurance score=exercise duration (seconds) x 100/sum of heart rate during the recovery period/2. The sum of heartbeats during the recovery period is the sum of heartbeats during 3 periods after testing: 1 to 1.5 minutes, 2 to 2.5 minutes, and 3 to 3.5 minutes.

Conclusion: The results indicate that across the various parameters analyzed, the athletes who wore the bioceramics all performed better than the athletes who wore the placebo garment.

Example 14 Effect of Far Infrared Radiation Emitted by Bioceramics on Clinical Fitness Measures.

Objective: To evaluate the effect of bioceramic far-infrared radiation therapy on flexibility, grip strength, and tidal volume in a randomized, double-blind, placebo-controlled study of 9-12 Florida Atlantic University basketball players (age 18-22).

Methods: Each participant was randomized to wear a bioceramic t-shirt (a t-shirt with a screen printed bioceramic) containing a bioceramic according to example 1, or a fake t-shirt (no bioceramic). Baseline assessments were made in week 1. The players wore the T-shirts three times a week during practice hours from 9 am to 12 noon. Evaluations were performed in both groups once a week for three consecutive weeks on Wednesdays during the first hour of daily training. On the second round of testing, the groups were swapped. The group that wore the Sham BioPower Practice Uniforms (simulation uniform) was selected to wear BioPower T-shirts 7 times a week (all day long) and the group that previously wore the BioPower uniform stopped wearing and served as controls. Evaluations were performed in both groups once a week for 3 consecutive weeks on Wednesdays during the first hour of daily training.

Flexibility was measured using the Sit-and-reach test (Novel Flex-Tester® Sit & Reach Box). For evaluation, each subject was asked to sit on the floor with the knees firmly pressed to the floor and the soles of the feet pressed firmly against the measuring box. The subject then leaned over the box and tried to reach the scale mark. The average of three measurements was used in the analysis.

Dominant hand grip strength was measured using a Baseline Smedley Digital Spring Hand Dynamometer with subjects standing with their elbows extended. The average score of the three attempts was recorded for analysis.

The tidal volume of the lungs was assessed using a spirometer (model SP-10). The parameters assessed were forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF). The best of the three scores was used for analysis. Forced vital capacity (FVC) is the volume of air forcefully exhaled after the deepest possible breath, measured in liters. FEV1 is the volume of air exhaled during the first second of forced exhalation. Peak expiratory flow (PEF) is the maximum flow (or rate) achieved during a maximally forced exhalation starting from a full inspiration, measured in liters per minute.

- 29 041903

Results.

Flexibility.

Fig. 3 is a graphical illustration of a non-limiting example of the effects of the bioceramics of the present invention on flexibility. In the first round of testing, the use of bioceramics did not affect flexibility from baseline (Fig. 3, panel A). In the second round of testing, compared to baseline, the use of bioceramic technology increased flexibility by 5.5 and 14.1% in the first and second weeks of continuous use, respectively. Flexibility did not change in the group of athletes who did not use the technology (Fig. 3, panel B).

Grab strength.

In the first round of testing, the use of bioceramics increased grip strength by 5.6% in the second week of continuous use relative to baseline levels. The grip strength in the control group did not change (Fig. 3, panel C). In the second round of testing, compared to baseline, grip strength increased by 10.8 and 10.9% with the use of bioceramic technology in the first and second weeks of continuous use, respectively (Fig. 3, panel D). On the other hand, in the group consisting of athletes who used the technology for 2 weeks (in the first round of testing) and interrupted its use, there was a decrease in grip strength of 7.23 and 13.51% in the first and second weeks, respectively (Fig. 3, panel D).

Respiratory volume of the lungs.

In FIG. 4 and 5 are graphs illustrating a non-limiting example of the effects of the bioceramic of the present invention on lung tidal volume. In FIG. 4 shows a non-limiting example of the effect of the bioceramic of the present invention on forced vital capacity (FVC) and forced expiratory volume in the first second (FEV1). In FIG. 4 shows a non-limiting example of the effect of the bioceramic of the present invention on peak expiratory flow (PEF). In the first round of testing, the use of bioceramics increased FVC (5.8% Fig. 4, panel A) and FEV1 (5.9% - Fig. 3, panel C), but did not affect PEF (Fig. 5, panel A) by compared to baseline. In the control groups, there was a decrease in FVC, FEV1 and PEF from one score to another (Fig. 4, panels A and C, and Fig. 5, panel A). In the second round of testing compared to baseline, the use of bioceramic technology increased the FVC (5.8% in the second week - Fig. 4, panel B); FEV1 (15 and 10% in the first and second weeks, respectively - Fig. 4, panel D), as well as PEF (52.77 and 50.9% in the first and second weeks, respectively - Fig. 5, panel B). In the group consisting of athletes who applied the technology by wearing for 2 weeks (on the first round of testing) and discontinued its use, FVC and FEV1 deviated from one score to another (Fig. 4, panels B and D, respectively), while PEF, on the other hand, decreased by 19.7% in the first and 23.3% in the second week of evaluations (Fig. 5, panel B).

Conclusion: Far-infrared radiation therapy emitted by bioceramic T-shirts improved flexibility, grip strength, and tidal volume in healthy Florida Atlantic University basketball players. Continuous long-term use produced the most significant results.

Example 15 Effect of a Bioceramic Imprinted Body Worn Product on Muscle Endurance and Cardiorespiratory Endurance in Athletes.

Purpose of the study: To evaluate the effect of training clothing (shirts and shorts) with imprinted bioceramics on muscle endurance and cardiorespiratory endurance.

Test method and results: Each participant wore a bioceramic t-shirt/shorts during training (3 times a week - training for 120 min). Additionally, participants wore the bioceramic T-shirt for 6-8 hours per day, 7 days per week. Assessments were made once a week on Mondays.

(a) Muscle endurance.

Muscle endurance was measured using a push-up test. Subjects were asked to (1) lie on the floor on their stomach with arms slightly wider than shoulder width, then (2) lift their torso off the floor by straightening their arms with a straight torso. The maximum number of push-ups performed to exhaustion was used as a measure of muscle endurance.

In FIG. 6 shows the effect of bioceramics on human muscle endurance. The data shown in FIG. 6 show the presence of a gradual increase in the maximum number of push-ups performed by athletes. The best increase compared to the assessment carried out without the use of bioceramics was obtained at week 4 (13.95%). In FIG. 6 shows the results of an experiment in which N=5. The numbers above the column represent the increase from the No BioPower control week.

(b) Cardiorespiratory endurance.

Cardiorespiratory endurance was assessed using a standardized test with minor deviations. The cardiorespiratory endurance score was derived from the recovery of heart rate after testing by the following formula: cardiorespiratory endurance score=exercise duration (seconds) x 100/sum of heart rate during the recovery period/2. The sum of heart beats during the recovery period is the sum of heart beats during the three periods after testing: 1 to 1.5 minutes, 2 to 2.5 minutes, and 3 to 3.5 minutes ² . Two evaluations were carried out: the first after

10-minute warm-up and a second after the 1-minute push-up test described in paragraph 3.2. A standard time of 3 minutes was used in the calculations to normalize the results of both tests to facilitate comparisons.

In FIG. 7 shows the effect of bioceramics on human cardiorespiratory endurance, as well as the results of an experiment in which N=5. In FIG. 7, panel A, shows the results of the evaluation performed after the warm-up. In FIG. 7, panel B, shows the results of the evaluation performed after the push-up test. The numbers above the columns represent the increase from the No BioPower control week.

The results shown in FIG. 7 indicate that the use of bioceramic increased the cardiorespiratory endurance score in all post-workout (FIG. 7, panel A) and push-up test (FIG. 7, panel B) scores. The maximum increase compared to the assessment carried out without the use of bioceramics occurred at week 3 (6.10 and 7.69%).

Conclusion: The results indicate that the use of a bioceramic-embossed body wear product increased muscle endurance and cardiorespiratory endurance in 5 mixed martial arts fighters.

Example 16 Effect of Bioceramic Paint on CFA-Induced Mechanical Hypersensitivity

Purpose of the study: Evaluation of the use of bioceramic paint containing the composition according to example 1 on CFA-induced mechanical hypersensitivity.

Methods: Experiments were performed using adult male Swiss mice weighing 25-35 g housed at 22° C. under a 12 h light/12 h dark cycle (lights on at 6:00 am), with ad libitum access to food and water. Experiments were performed after approval of the protocol by the Ethics Committee of the Universidade do Sul de Santa Catarina (UNISUL). Animals (n=8) were subjected to an intraplantar injection (right hind leg) of a solution containing 20 μl of complete Freund's adjuvant (CFA, 70%). For treatment, bioceramic paint (concentration of 10 and 20%) was applied to the bottom of the box with animals. After 24 hours of exposure, the mechanical nociceptive threshold was assessed as the frequency of responses to 10 applications of 0.4 g of von Frey thread on the right hind paw of the animals. Evaluations were performed on days 2 and 3 after CFA injection.

Results: The results showed that CFA intraplantar injection induced mechanical hypernociception (P<0.001), which was significantly reduced by exposure to bioceramic paint (20 but not 10% bioceramic concentration) applied to the bottom of the animal box. The effect lasted for 4 hours (day 2 and 3). In FIG. 8 shows the effects of a bioceramic dye on CFA-induced mechanical hypersensitivity. Evaluation of 8 individuals, vertical lines represent S.E.M. *p<0.05. In FIG. 9 shows a bioceramic paint.

Conclusion: The bioceramic dye reduced mechanical hypersensitivity induced by CFA paw injections.

Example 17 Far infrared radiation emitted by ceramic materials increases paw temperature and reduces mechanical hypersensitivity and swelling of the knee in a rat model of monoiodoacetate-induced osteoarthritis.

Objective: This study investigates the effect of far-infrared radiation emitted by ceramic materials on skin temperature, paw mechanical hypersensitivity, and knee edema in a rat model of monoiodoacetate (MIA)-induced osteoarthritis.

Methods: Experiments were performed on male Winsar rats (200-250 g) anesthetized with a mixture of ketamine and xylazine (50 and 10 mg/kg, respectively, intraperitoneally (ip)). Joint injury was induced by a single intra-articular injection of MIA (1 mg/50 μl; Sigma UK - which disrupts glycolysis leading to chondrocyte death) through the right knee subpatellar ligament. Control animals received a single injection of saline (50 μl). Three separate indicators were evaluated:

(1) thermal analyzes of the central regions of the forepaws of animals (using the ThermaCAM® E320 handheld thermal imager - from Flir, Sweden - with a resolution of 320x240 pixels, thermal sensitivity <0.10°C at 25°C and an accuracy of ±2°C - positioned at a distance of 0.5 m from the animal's paw.Infrared images were analyzed using FLIR QuickReport 1.2 software);

(2) hindpaw withdrawal mechanical stimulus thresholds (using von Frey monofilaments - Semmes-Weinstein monofilaments with a bending force of 1-15 g) that provide an indicator of central sensitization; and (3) edema formation (measured with a digital caliper - Pantec, Brazil) directly related to local inflammatory response. For treatment bioceramic pad,

- 31 041903 containing bioceramics according to example 1 (80% BioCorn PVC - 20% ceramic material), was placed in a box with animals; control animals were placed on a sham pad (100%

BioCorn PVC without ceramic) and subjected to the same experimental protocol.

Results: On day 3 post MIA injection, acute exposure (2 h) to the bioceramic pad increased paw temperature (±4°C), although only prolonged exposure (day 7 and 10 post MIA injection) reduced mechanical hypersensitivity (p<0.001) and edema. knee (p<0.001).

Conclusion: Far-infrared radiation emitted by ceramic materials increased paw temperature (after acute exposure), while long-term treatment alone reduced mechanical hypersensitivity and knee swelling in a rat model of MIA-induced osteoarthritis.

Example 18 Far infrared radiation emitted by bioceramics reduces hypernociception of inflammatory origin in mice.

Purpose: The purpose of this study is to evaluate the effect of far infrared radiation emitted/reflected by the bioceramic in the pad containing the bioceramic according to Example 1 on pain of inflammatory origin, as well as on the increase in paw temperature and the formation of edema in an experimental model of inflammation in mice.

Methods: Experiments were performed using adult male Swiss mice weighing 25-35 g housed at 22° C. under a 12 h light/12 h dark cycle (lights on at 6:00 am), with ad libitum access to food and water. Experiments were performed after approval of the protocol by the Ethics Committee of the Universidade do Sul de Santa Catarina (UNISUL). Animals (n=8) were injected intraplantarly (right hind leg) with a solution containing 20 µl of complete Freund's adjuvant (CFA, 70%). For treatment, the bioceramic pad was placed in a box with animals. After 24 hours of exposure to the product, the mechanical nociceptive threshold was assessed as the response rate per 10 applications of 0.4 g of von Frey thread on the right hind paw of the animals. Assessments were performed daily for 10 days - after each assessment, the animals were returned back to the boxes and re-padded until the next assessment (24 hours). In addition, volume (edema formation) and temperature of the right hind paws were assessed on experimental days 1, 3, and 10 using a plethysmometer and digital thermometer, respectively. Control animals were placed on a sham pad composed of 100% BioCorn PVC (no bioceramics) and subjected to the same experimental protocol.

Results: The results showed that CFA intraplantar injection induced mechanical hypernociception (P<0.001) which was significantly reduced by acute exposure to a bioceramic pad containing bioceramic according to Example 1. Analgesia lasted up to 2 hours with a maximum effect 30 minutes after treatment (P<0.001 maximum inhibition was 53±11%). Long-term treatment with the bioceramic pad reduced mechanical hypernociception on all assessment days. In addition, treatment significantly reduced paw temperature on days 1 and 3, 8±1% (P<0.001) and 5±1% (P<0.05), respectively, compared with the control group.

Conclusion: The bioceramic pad reduced paw temperature induced by CFA intraplantar injection in mice.

Example 19 Application of Far Infrared Bioceramics to Treat Human Diseases.

Bioceramics emitting infrared energy are used to modulate or treat one or more of the following: pain, muscle endurance, body resistance, muscle strength, cardiorespiratory endurance, lung tidal volume, flexibility, cellular metabolism, analgesia, cellular oxidation, fibromyalgia, inflammation, oxidative stress, circulation, cold intolerance, arthritis or vascular disease, skin perfusion, arrhythmia, high blood pressure, tissue damage, aesthetic effect such as reduction of cellulite in the subject, improved quality of life.

Methods: The subject wears an article of the invention containing a bioceramic for at least 6 weeks. The following parameters or endpoints, alone or in combination, are used to measure the effects of articles impregnated with infrared-emitting ceramic material(s) in the treatment of human subjects having the condition disclosed herein:

a) quality of life, sleep phases, depression and anxiety;

b) pain, muscle strength and flexibility;

c) static pressure balance and distribution;

d) stress (measured by the activity of the autonomic, sympathetic and parasympathetic nervous systems;

e) body surface temperature;

f) inflammatory mediators (anti- and pro-inflammatory cytokines) or

- 32 041903

g) oxidative stress and oxidant systems.

Bioceramic Treatment Methods: T-shirts or pads impregnated with BioPower® brand infrared-emitting bioceramic material or control T-shirts were distributed between groups. Patients were instructed to wear a piece of clothing containing ceramic materials during the day, at night, or while sleeping. The treatment was carried out for about three consecutive months. In FIG. 10 shows a human subject wearing exemplary T-shirts or pads containing the ceramics of the invention.

Study Endpoints: Some of the following endpoints, alone or in combination, were used to quantify the efficacy of the bioceramic material in a subject: a) grip strength assessment; b) flexibility assessment; c) thermography; d) assessment of pro-inflammatory and anti-inflammatory cytokines; e) assessment of antioxidants, assessment of markers of oxidative stress or f) questionnaires.

Grip Strength Evaluation: A dynamometer was used as a tool to evaluate grip strength. The principle of operation of a dynamometer is based on the deformation of a spring under the action of a load attached to it, which moves downward under the influence of a force. Force intensity is graduated, so a dynamometer is a useful way to measure force in some subjects. The dynamometer is particularly useful for measuring force intensity, for example, in a human subject afflicted with fibromyalgia, as the dynamometer readings take into account total and predominant muscle fatigue in the upper limbs (UL) and appendicular skeleton compared to axial upper limb studies.

Flexibility Evaluation: Flexibility was assessed using the Third Finger-Soil test. The instrument measures the overall flexibility of the subject in terms of bending the subject from a standing position, the ability of the subject to keep their feet together, and the maximum flexibility of the subject's spinal column, without bending the knees. This measurement was carried out on subjects with a relaxed head, and the distance between the ground and the third finger of the hand was measured using a measuring tape on the right or left side. A subject that could touch the ground was considered a subject with good flexibility.

Thermographic Evaluation: Thermography is a useful technique for analyzing hyperradiance points in an infrared image because it allows detection of thermographic images on a subject's skin surface, such as the skin of a human body. This method can be applied to a human subject who is in a standing position and without clothes, with arms extended along the body, but not touching the body. The temperature is maintained at approximately 20°C throughout the procedure. Prior to imaging, subjects are asked to rest for 15 min to allow body temperature to acclimate to the controlled room temperature.

Evaluation of pro-inflammatory and anti-inflammatory cytokines: Blood samples were collected and prepared for analysis by centrifugation (IL-10, IL-6, IL-1e and TNF-α). Serum was processed for cytokine analysis. Serum can be stored frozen at 80°C for one year. Serum was analyzed by immunoassay (pg/dl) (Sandwich ELISA) using commercial kits and the concentration of cytokines was determined. One of skill in the art will appreciate that other methods known in the art can be used to assess levels of pro-inflammatory and anti-inflammatory cytokines.

Assessing Antioxidants and Determining Oxidative Stress:

a) thiobarbituric acid-TBARS responsive substances: To determine the effects of bioceramics on modulating oxidative stress, a sample containing serum lipids was collected from a subject. The sample was analyzed by heating it in an acidic reaction with 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 was mixed with 1 ml of 10% trichloroacetic acid and 1 ml of 0.67% thiobarbituric acid and then placed in a boiling water bath for 15 minutes. Absorbance at 535 nm was measured using 1,1,3,3-tetramethoxypropane as an external standard. The results were calculated and presented as equivalents of malondialdehyde per 1 mg of protein. One of skill in the art will appreciate that other methods known in the art can be used to assess levels of oxidative stress in a sample;

b) protein carbonylation: the effect of oxidative stress on proteins was evaluated based on the reaction of carbonyl groups with dinitrophenylhydrazine (Levine et al., 1990) (Levine, R.L.; Garland, D.; Oliver, C.N.; Amici, A.; Climent, I.; Lenz, A. G.; Ahn, B. W.; Shaltiel, S.; Stadman, E. R. Determination of carbonyl content in oxidatively modified proteins Methods Enzymol, v. 186, pp. 464-478, 1990; incorporated here by reference). Briefly, proteins were first precipitated by adding 20% trichloroacetic acid and dissolved in dinitrophenylhydrazine, and then absorbance was measured at 370 nm. The results were expressed as the levels of carbonyl groups of the protein per 1 mg of protein. One of skill in the art will appreciate that other methods known in the art can be used to assess protein carbonylation levels;

c) the degree of oxidative damage to the sulfhydryl group of proteins: oxidative damage

- 33 041903 Protein densities were analyzed by determining damage to sulfhydryl groups (previously described by: Aksenov et al. (Aksenov, M.Y., Markesbery, W.R. Changes in thiol content and expression of glutathione redox system genes in the hippocampus and cerebellum in Alzheimer disease. Neurosci. Lett ., v. 302, p. 141145, 2001). Briefly, the proteins in the sample were precipitated and dissolved in dithionitrobenzoic acid. Absorbance was measured at 412 nm. Results were expressed as TNB levels per 1 mg of protein. One skilled in the art will appreciate that other methods known in the art can be used to assess oxidative damage to the sulfhydryl group of proteins;

d) Enzyme Antioxidant Activity: Catalase (CAT) activity was determined by measuring the reduction in hydrogen peroxide uptake at 240 nm. Data were plotted as units per 1 mg of protein. Superoxide dismutase (SOD) activity was determined by inhibition of adrenaline autoxidation measured spectrophotometrically at 480 nm (described by Bannister, J.V.; Calabrese, L. Assays for superoxide dismutase. Methods Biochem Anal, v. 32, p. 279-312, 1987) and expressed as units of activity per 1 mg of protein. One of skill in the art will appreciate that other methods known in the art can be used to assess levels of enzymatic activity;

e) determination of total protein: all biochemical assays can be normalized to protein content using bovine serum albumin as a standard using the methods described, for example, by Lowry, Rosebrough, and Farr (Lowry, O.H.; Rosebrough, N.J.; Fair, A Protein measurement with the Folin phenol reagent J. Biol Chem., v. 193, pp. 265-275, 1951).

The subject obtains at least one of the following beneficial effects when using the body-worn article of the invention: reduction of pain, increase in muscle endurance, increase in body resistance, increase in muscle strength, modulation of cardiorespiratory endurance, such as an increase in lung tidal volume, increase in flexibility, modulation cellular metabolism, improved analgesia, antioxidant effect, antifibromyalgic effect, reduced inflammation, reduced oxidative stress, modulated cytokine levels, modulated blood circulation, reduced cold intolerance, reduced symptom of arthritis or vascular disease, increased skin perfusion, decreased heart rate, lowered blood pressure, faster recovery after injury or training, aesthetic effect such as reduction of cellulite in the subject, improved quality of life.

Example 20 Use of Far Infrared Bioceramics for the Treatment of Human Fibromyalgia.

Fibromyalgia is a painful chronic condition, usually accompanied by various symptoms and predominantly affecting the musculoskeletal system. In Brazil, 2.5% of the population is affected by fibromyalgia. According to the latest epidemiological data, approximately 2% of the world's population is affected by fibromyalgia. The main symptoms of fibromyalgia are associated with persistent pain lasting more than three months, sleep disturbances, fatigue, anxiety, parasthesia, headaches, and pressure points. There is an ongoing debate about the main causes of fibromyalgia, but research points to a possible link between fibromyalgia and genetic causes, trauma, infections, and stress.

Purpose of Study: This study evaluates the effects of garments impregnated with infrared-emitting ceramic material(s) (bioceramics) versus water gymnastics on the symptoms and prognosis of patients diagnosed with fibromyalgia.

Study design: This study is based on a blinded, randomized clinical trial. It is designed to adequately compare the effectiveness of different treatments; patients were randomly assigned to groups in order to avoid bias. Individuals were randomized as follows (n=25 per group):

group 1: control group not receiving treatment with hydrokinesitherapy or bioceramics;

group 2: treated only with bioceramic materials;

group 3: received treatment only with the use of hydrokinesitherapy;

group 4: received treatment using hydrokinesitherapy and bioceramics.

Hydrokinesitherapy treatment: Exercises previously described in Berti et al., (2008) (BERTI, Gabriela et al. RS. Revista digital de Educatión Fisica in Desportes, n. 122, 2008; incorporated here by reference) was performed, for example, in a UNISUL Aquatic Complex temperature controlled pool. Alternatively, the exercises may be performed in any suitable pool.

The exercises were performed in four phases, covering 36 sessions of 1 hour each, three times a week per group. During the first phase, a general warm-up is carried out along the pool line with movements forward and laterally. The second phase may last approximately 15 minutes and may include active stretching of the upper and lower muscles with a 20 second delay. The duration of the exercises in the third phase is about 20 minutes, and the exercises are designed in such a way that the activity in the upper and lower

- 34 041903 body elements are practically absent. Finally, the fourth phase may consist of relaxation exercises characterized by oscillatory movements performed under the supervision of a physiotherapist.

Conclusion: One or more of the endpoints/parameters described in Example 19 was used to determine the efficacy of a far infrared bioceramic in the treatment of human fibromyalgia. It has been hypothesized that the ceramic of the invention is effective in treating a person having fibromyalgia.

Example 21 Randomized placebo controlled trial to test the effectiveness of bioceramics as an adjunct in the treatment of chronic low back pain in humans with physical therapy.

Low back pain (LBP) is a common complaint in today's society and a significant cause of discomfort in adults under 45 years of age. Debilitating pain in the lower back that lasts more than 3 months is considered chronic. Chronic low back pain (CLBP) can be caused by a variety of causes that can be treated in a variety of ways, such as bed rest, lumbar support, traction, thermotherapy, electrical stimulation, and manipulation in most cases. Invasive therapies such as surgery, blockage of a specific nerve root, and epidural injection may be used to treat chronic low back pain.

Purpose of Study: The purpose of this study is to evaluate the effect of a body wear article according to the invention containing a bioceramic that emits radiation energy in the far infrared spectrum for the treatment of chronic back pain.

Methods: The study is designed as a controlled clinical trial to test the effectiveness of a far infrared emitting ceramic sleeve or patch as an adjunct in the treatment of chronic low back pain through physical therapy.

Experimental: Subjects follow a regular physical therapy (PT) regimen at the Wilfred R. Cameron Wellness Center clinic in Washington, PA. Subjects are randomly divided into three experimental groups:

a) control: receive only RT therapy;

b) bioceramic patch: receive RT therapy and apply the bioceramic patch for n hours after treatment;

c) placebo: receive PT treatment and use a placebo patch (no bioceramic) for n hours after treatment.

Pain and Disability Assessment: The Oswestry Back Pain Disability Index (ODI) questionnaire was used to assess pain levels; the Roland-Morris Low Back Pain and Disability Questionnaire and the Backache Index (BAI). It has been hypothesized that the patch of the invention would be effective in treating a person with chronic back pain.

Example 22 Application of Far Infrared Bioceramics for the Treatment of Human Pain.

A subject with chronic back pain wears a pad according to the invention. The effectiveness of the pad was evaluated in the study described in example 21, or other suitable study. An exemplary chronic back pain pad is the pad shown in FIG. 2 worn as shown in FIG. 10, vertically or horizontally.

Experimental: A subject with chronic back pain wears a pad daily for about 6 consecutive weeks for 7 consecutive days. The pad provides the subject with some infrared energy. The amount of infrared energy received by the subject is the following (far infrared radiation wavelength in the range of 9 to 10 microns):

*fabric screen printed with ink at 50% concentration of bioceramic: radiation intensity of 4.05 mW/cm ² at body temperature of 36.5°C provides about 2.43 J/cm ² for 1 hour of application;

*fabric screen printed with ink at 30% bioceramic concentration: 3.65 mW/ ^cm2 radiation intensity at 36.5°C body temperature provides about 2.19 J/ ^cm2 for 1 hour of application.

The treatment provides relief to a subject with chronic back pain.

The subject wants to prolong the relief of chronic back pain. The subject may consult with a therapist or physical therapist regarding treatment regimens and conditions. The subject adjusts the treatment regimen to prolong the feeling of relief by wearing the patch for a longer time. The subject experiences long-term relief from chronic back pain.

Example 23 Use of Bioceramics Emitting Far Infrared Radiation Energy for the Treatment of Human Capral Tunnel Syndrome

Capral tunnel syndrome (CTS) is a compression neuropathy that is caused primarily by compression of the median nerve and irritation at the level of the carpal tunnel. Its symptoms include pain and parasthesia in the wrist and hand, which may radiate to the forearm.

CTS affects 1 to 3% of the population, with a higher incidence in people of certain occupational groups who perform repetitive hand and wrist movements.

Purpose: The purpose of this study is to evaluate the effect of a body wear article according to the invention containing a bioceramic that emits radiation energy in the far infrared spectrum, for the treatment of corporal tunnel syndrome.

Methods: A randomized, placebo-controlled, pilot clinical trial to test the efficacy of a far-infrared-emitting ceramic sleeve as an adjunct in the treatment of corporal tunnel syndrome with physical therapy.

Experimental: Subjects follow a regular physical therapy (PT) regimen at the Wilfred R. Cameron Wellness Center clinic in Washington, PA. Subjects are randomly divided into three experimental groups:

a) control: receive only PT therapy;

b) bioceramic sleeve: receive PT therapy and use a bioceramic patch for n hours after treatment;

c) placebo: receive RT treatment and use a placebo sleeve (without bioceramics) for n hours after treatment.

End points measured: 1) Assessment of pain and level of disability: The Boston Carpal Tunnel Syndrome Questionnaire is used to determine the effectiveness of the sleeve of the invention in the treatment of corporal tunnel syndrome; and 2) grip strength (muscle strength) assessment: Muscle strength of the affected dominant hand is measured using a Digital Spring Hand Dynamometer (Baseline Smedley, USA) with subjects standing with elbows extended. It has been hypothesized that the sleeve according to the invention would be effective in treating a person with corporal tunnel syndrome.

Example 24 Use of Bioceramics Emitting Far Infrared Radiation Energy to Treat Inflammation in Humans

Purpose: The purpose of this study is to evaluate the effect of a body-worn article according to the invention, such as a T-shirt, sleeve or pad, containing a bioceramic that emits radiation energy in the far infrared spectrum, for the treatment of inflammation.

Methods: The study is designed as a controlled clinical trial to test the efficacy of a far infrared energy-emitting ceramic sleeve or patch as an adjuvant in the treatment of inflammation in humans, such as joint inflammation in a person with arthritis.

Type of study: intervention. Subjects were randomly assigned to three experimental groups;

a) group 1: no treatment;

b) group 2: wears an article according to the invention: T-shirt, pad or both for n hours after treatment;

b) group 3: wears a control item that does not contain bioceramics for n hours after treatment.

Endpoint Classification: The efficacy of bioceramics in treating inflammation is determined based on the expression of the following cytokines: individually or as a group: TNF-α, IL-1e, IL-10 and IL-6. The uptake intensity for the above cytokines is measured using a microplate reader at 450 and 550 nm. Cytokine levels in humans are used to confirm the anti-inflammatory effect of bioceramic compositions.

Example 25 Self-reported levels of overall pain, overall well-being, overall fatigue, overall sleep quality, and overall performance levels in people participating in the Zumba fitness program.

An interactive questionnaire was used to assess the effect of bioceramic materials in subjects participating in the Zumba Fitness Program (ZUMBA®). Subjects were asked to report how many times per week they practice Zumba. Subjects attending zumba classes were selected for further analysis. 10 subjects were asked to answer the following questions:

1) How would you rate your overall pain level over the past 2 weeks? Choose the number that best describes your pain: 1 = no pain, 10 = worst. In FIG. 12 is a graph illustrating a self-assessed reduction in overall pain levels of greater than 7.5% in human subjects treated with a body-worn article of the invention.

2) How do you rate your general level of well-being over the past 2 weeks? Choose the number that best describes how you feel overall: 1 = very good, 10 = very poor.

- 36 041903 hoe. In FIG. 13 is a graph illustrating a self-assessed improvement in overall well-being of more than 46% in human subjects who wore a t-shirt according to the invention during a Zumba fitness program.

3) How would you rate your overall level of fatigue over the past 2 weeks? Choose the number that best describes your overall level of fatigue: 1 = very low, 10 = very high. In FIG. 14 is a graph illustrating a self-assessed reduction in overall levels of fatigue of greater than 25% in human subjects who wore a t-shirt according to the invention during a Zumba fitness program.

4) How would you rate the overall quality of your sleep over the past 2 weeks? Choose the number that best describes the overall quality of your sleep: 1 = very good, 10 = very poor. In FIG. 15 is a graph illustrating a self-assessed improvement in overall sleep quality of greater than 8.5% in human subjects who wore a T-shirt according to the invention during a Zumba fitness program.

5) How would you rate your overall performance over the past 2 weeks? Choose the number that best describes your overall performance level: 1 = very good, 10 = very poor. In FIG. 16 is a graph illustrating a self-assessed improvement in overall performance of greater than 7% in human subjects who wore a T-shirt according to the invention during a Zumba fitness program.

Conclusion: Wearing a bioceramic T-shirt according to the invention reduces overall pain, improves overall well-being, reduces overall fatigue, improves overall sleep quality, and improves overall performance levels of individuals participating in the Zumba fitness program.

Example 26 Far Infrared Radiation Report of Bioceramic Materials.

Absolute Radiation Report: Based on 9-11 µm infrared radiant energy emission analysis performed at the Laboratory of Spectroscopy and Laser Institute of Exact Sciences, Federal University Fluminense using a Scientech calorimeter (Boulder, CO, USA), model 118 , serial number 380802, attached to a Scientech power and energy measurement unit, model 473, serial number 364002, on the following materials:

1) smooth fabric (not containing bioceramics);

2) bioceramic fabric (30% bioceramic), bioceramic was prepared as described in example 1;

3) bioceramic fabric (50% bioceramic), bioceramic was prepared as described in example 1.

The emissivity analysis was performed based on the Stefan-Boltzmann equation:

P = εσT ⁴ , where P is the radiation power per unit area (W/m ² );

ε - emissivity of the plate (without units);

σ - Stefan-Boltzmann constant (5.7x10'8 W/m ² -K ⁴ );

T is the temperature of the materials in Kelvin.

The emissivity of a material and dimensionless quantity is a property of a material, refers to the ability to release energy by radiation from its surface and the ratio of the energy emitted by a particular material urn to the energy emitted by a black body (e=1). Any object that is not a true blackbody has an emissivity that is less than 1 and greater than 0.

For analysis, the materials were cut into discs with a diameter of 15 mm and placed in a heat-insulated oven and electronically maintained at these temperatures (with a deviation of ±1°C). After thermal equilibrium was established, the furnace set/disk was placed in front of the calorimeter and the radiation was measured. Potential measurements per 1 m ² for each material were corrected depending on the high fourth power of temperature in Kelvin. The emissivity value was calculated from the slope of a straight line constructed from points using the least squares method performed using the free QtiPlot program. The following results were obtained:

1) smooth fabric (not containing bioceramic): radiation 0.68 (Fig. 17);

2) bioceramic fabric (30% bioceramic): radiation 0.70 (Fig. 18);

3) bioceramic fabric (50% bioceramic): radiation 0.74 (Fig. 19).

The results correspond to the average value of the measurements; five measurements were averaged for each material with a tolerance of ±0.02. In the tested samples, the addition of bioceramic materials increased the absolute value of the emissivity of the materials, which confirms the higher emission of radiant energy in the far infrared range between 9 and 11 µm.

Example 27 Application of Far Infrared Bioceramics Improves Back, Leg and Grip Strength, Improves Lung Tidal Volume, and Increases Cardiorespiratory Endurance

Purpose: The purpose of this study is to evaluate the effect of the body-worn article according to the invention on improving flexibility, increasing back, leg and grip strength, improving respiratory lung volume, and improving cardiorespiratory endurance in humans.

Methods: The study is designed as a controlled, double-blind clinical study to test the statistical effects of a far-infrared-emitting bioceramic T-shirt, sleeve, or patch on improved flexibility, back, leg, and grip strength, improved lung tidal volume, and increased cardiorespiratory endurance in human

Study type: Interventional. Subjects were randomly assigned to three experimental groups that received treatment for at least 6 weeks:

a) group 1: no treatment;

b) group 2: wears a body wear according to the invention: T-shirt, pad or both for n hours after treatment;

c) group 3: wearing a control body wear that does not contain bioceramics for n hours after treatment.

n hours can be about 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11, about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21, about 22, about 23 or about 24 hours during the day.

Study Endpoint Classification: Flexibility, back, leg and grip strength, tidal volume, and cardiorespiratory endurance were measured as previously described in Examples 11, 13, 14, 19, and 20.

Example 28 Use of Far Infrared Bioceramics as an Analgesic in Mice.

Purpose: The purpose of this study is to evaluate the analgesic effect of different bioceramic concentrations and duration of treatment in an experimental model of CFA-induced inflammation in mice.

Methods: Experiments were performed using adult male Swiss mice weighing 25-35 g housed at 22° C. under a 12 h light/12 h dark cycle (lights on at 6:00 am), with ad libitum access to food and water. Experiments were performed after approval of the protocol by the Ethics Committee of the Universidade do Sul de Santa Catarina (UNISUL). Animals (n=8) were injected intraplantarly (right hind leg) with a solution containing 20 µl of complete Freund's adjuvant (CFA, 70%). Animals not previously used in the experiments were injected with saline. The mechanical nociceptive threshold was assessed as the frequency of responses to 10 applications of 0.4 g of von Frey thread on the right hind paw of the animals.

In experiment number 1, the animals were placed in their boxes for 2 hours:

(1) on a pad made of 70% BioCorn PVC and 30% bioceramic;

(2) on a pad made of 90% BioCorn PVC and 10% bioceramic; or (3) a pad made of 100% BioCorn PVC and 0% Bioceramic.

After 2 hours of exposure, the mechanical nociceptive threshold was assessed. Animals not previously used in experiments were not treated.

In experiment number 2, animals were placed in their boxes on a pad composed of 70% BioCorn PVC and 30% bioceramic for 0.5, 1, or 2 hours. After that, the mechanical nociceptive threshold was assessed. Animals not previously used in experiments were not treated.

Results: The results indicated that CFA intraplantar injection induced mechanical hypernociception (P<0.001) which was significantly reduced by acute exposure to bioceramic-containing pads. Exposure to the pad with a higher concentration of bioceramic produced long lasting effects (FIG. 20, panel A). Longer exposure to the bioceramic pad produced longer lasting effects (FIG. 20, panel B).

Conclusion: Exposure to the bioceramic pad reduced mechanical hypernociception of inflammatory origin induced by CFA intraplantar injection in mice in a dose-dependent manner.

Example 29 Effect of Bioceramics on the Growth of Organic Products.

Purpose: Evaluation of the effect of BioPower® on the growth of hydroponic lettuce (Lactuca sativa).

Methods: The experiment was carried out using lettuce (Lactuca sativa) grown in a hydroponic system. The control group was grown following standard hydroponic growing methods. The experimental group (bioceramic) was treated with bioceramic beads (30% bioceramic, 70% polystyrene-polypropylene - 1 lb) placed in a water pump. Lettuce was grown for 3 weeks and harvested for analysis.

Results: The results indicate that the lettuce treated with bioceramic water weighed more and had more leaves compared to the control group. In FIG. 21 are graphs illustrating the effect of adding bioceramics to treatment water in a hydroponic system. n=12, vertical lines represent S.E.M. *p<0.05.

Electrical conductivity (EC) (expressed in microsiemens (µS)) is a measure of the ability

- 38 041903 nutrient solutions conduct electricity. Pure water (deionized water) is an insulator. It is the conductive substances (or ionized salts) dissolved in water that determine the degree of conductivity of the solution. With few exceptions, at a higher concentration of nutrients, the electrical current will flow faster and at a lower concentration, the electrical current will flow more slowly. This is because the amount of dissolved solids in the nutrient solution is directly proportional to the electrical conductivity. Thus, by measuring the EC, it is possible to determine how strong or weak the concentration of the nutrient solution is. In this case, the lower electrical conductivity in the experimental group (BioPower group) means a lower concentration of nutrients in the solution, suggesting that the plants treated with BioPower absorbed more nutrients than the plants in the control group. In FIG. 22 is a graph illustrating the lower electrical conductivity of bioceramic treated water present on days 16-20 compared to the control group (water only). In FIG. 23 are pictures showing lettuce at start of treatment - day 1 in the system (FIG. 23, panel A); lettuce after the first week of treatment (Fig. 23, panel B); lettuce after the third week of treatment (Fig. 23, panel C) and a snapshot of the bioceramic pellets used in the experiment (Fig. 24).

Example 30 Randomized, double-blind, placebo-controlled clinical trial of the effect of bioceramics emitting far infrared radiation energy in people participating in exercise or fitness programs.

Objective: To study the effect of a ceramic far infrared (cFIR) body wear on people who engage in a Zumba (ZUMBA®) workout or fitness program.

Description of the study: Bioceramics are refractory, inorganic, non-metallic polycrystalline compounds, which, due to their inertness in aqueous conditions, are highly biocompatible and are widely used in implants. The bioceramic fabrics and body wear items disclosed herein have been optimized for their ability to reflect/emit far infrared (FIR) radiation. The aim of this study is to evaluate the effect of fabrics containing bioceramics in combination with exercise or fitness programs on humans.

Study Design: Randomized, double-blind, placebo-controlled study.

Demographics: The study will include male and female subjects of varying ages.

Experimental: Human subjects participate in a Zumba (ZUMBA®) workout or fitness program. All human subjects participate in a Zumba workout or fitness program at least once a week. Subjects are randomly divided into three experimental groups:

Group 1 (Non-Treatment Control Group - Regular Garment): Subjects in this group wear regular control T-shirts and/or leggings (pants) during Zumba training or fitness programs;

group 2 (placebo control group - T-shirt and/or leggings (trousers) containing ceramics that do not reflect infrared energy or rays): subjects in this group wear control T-shirts and/or leggings (trousers) containing ceramics that do not reflect infrared energy or beams during a Zumba workout or fitness program;

group 3 (experimental group - T-shirts and/or leggings (trousers) containing about 50% by weight of the following bioceramic composition: about 18% aluminum oxide Al ₂ O ₃ , about 14% silicon dioxide SiO ₂ , about 50% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ ), about 8% zirconium oxide (ZrO ₂ ) and about 10% tourmaline (NaFe ²⁺ ₃ Al ₆ Si ₆ O ₁₈ (BO ₃ ) ₃ (OH) ₃ OH)): subjects in This group wears T-shirts and/or leggings (trousers) containing said bioceramics while doing Zumba exercises or fitness programs.

Experiments that measure the amount of infrared energy emitted by the above body-worn items are described in Example 26. Additional experiments are performed that measure the amount of infrared energy emitted by T-shirts before, during, and after participants perform Zumba exercises or fitness programs.

Evaluations: The following evaluation methods are used to measure the effect of bioceramic-containing tissues in humans in combination with exercise or fitness programs:

Body Composition: Body Mass Index (BMI) and Thallium Circumference: The percentage of body fat is measured either by skinfold measurement or by bioimpendance measurement (BIA). Body composition is assessed at least twice: 1) baseline assessment is carried out prior to intervention and control trials; and 2) at least one follow-up evaluation is performed 6 weeks after the start of the intervention.

Functional state of the cardiovascular system: Harvard step test (Harvard

- 39 041903

Step test) is used to measure aerobic and cardiovascular condition. The Harvard Step Test is a widely accepted method for measuring the increase in oxygen consumption with increasing intensity of exercise. _VO2max is defined as the highest rate of oxygen uptake achieved during maximal or strenuous exercise.

Harvard Step Test Protocol: The participant walks up and down the bench at 30 full steps per minute (1 second up, one second down) for 5 minutes or until exhaustion. Exhaustion is defined as when a competitor is unable to maintain up and down speed for 15 continuous seconds. Upon completion of the test, the subject sits down and the total heart rate is measured by measuring the pulse at the wrist at the following times:

a) 1-1.5 minutes after completion of the test;

b) 2-2.5 minutes after completion of the test;

c) 3-3.5 minutes after completion of the test.

The functional state of the cardiovascular system is assessed after the completion of a Zumba (ZUMBA®) workout or fitness classes:

1) baseline assessment is carried out before the start of intervention and control trials;

2) follow-up evaluations are performed after the completion of a Zumba (ZUMBA®) workout or fitness classes.

The subjects' fitness index score is then determined using the following equations:

Endurance Score = (100 x test duration in seconds)/(2 x sum of heart rate during recovery periods).

Flexibility: The flexibility of each human subject is measured using the Sit-and-reach test (Novel Flex-Tester® Sit & Reach Box). For evaluation, each subject is asked to sit on the floor with the knees firmly pressed to the floor and the soles of the feet firmly pressed against the measuring box. The subject then leans over the box and tries to reach the scale mark. The analysis uses the average of three measurements. Flexibility is assessed after completing a Zumba (ZUMBA®) workout or fitness classes:

1) the baseline assessment is carried out before the start of the intervention and control trials;

2) follow-up assessments are performed at least once a week for a total of six weeks after completion of a Zumba (ZUMBA®) workout or fitness classes.

Back and leg strength: Back/leg dynamometers (Baseline, United States) are used to measure leg and back muscle strength. The strength of the leg muscles is assessed in a standing position with the legs bent at the knees at an angle of 135°. To assess the strength of the back muscles, the participant is asked to stand on the platform with the legs bent at the knees at an angle of 135°. Using a pronated grip, participants hold the handle of the device and slowly straighten their legs to their maximum level without using their back or shoulder muscles. To assess back muscle strength, subjects are asked to repeat the described procedure using only their back muscles (knees kept straight). Flexibility is assessed after completing a Zumba (ZUMBA®) workout or fitness classes:

1) baseline assessment is carried out before the start of intervention and control trials;

2) follow-up assessments are performed at least once a week for a total of six weeks after completion of a Zumba (ZUMBA®) workout or fitness classes.

Questionnaires: Subjects may be asked to answer questions contained in questionnaires designed to assess the effects of an intervention on parameters related to: general health, sleep, pain, feeling of well-being, or quality of life. Illustrative questionnaires include the Short-Form health survey (SF-36); Pittsburg sleep quality index (PSQI); McGill Pain Questionnaire; Wellness Questionnaire; WHO Quality of Life Questionnaire (WHOQOL-BREF); the questionnaire described in example 25, and/or a plurality of variants thereof.

Example 31 Randomized, double-blind, placebo-controlled clinical study of the effect of bioceramics emitting far-infrared radiation energy in people participating in exercise or fitness programs.

Objective: To evaluate the effect of T-shirts containing far infrared (cFIR) ceramics on physical endurance parameters.

Methods: Participants were randomly assigned to two experimental groups:

experimental group I (t-shirts containing cFIR): each participant wears a t-shirt containing cFIR for a minimum of 4 hours after the training protocol and for a minimum of 4 hours daily between workouts;

experimental group II (placebo t-shirts): participants wear a placebo t-shirt (without cFIR) for a minimum of 4 hours after the training protocol and for a minimum of 4 hours daily between workouts.

Study type: Randomized, double-blind, placebo-controlled clinical trial.

Fitness Program: Subjects participate in Pilates training for 1 hour 3 times per week. The standardized progressive treatment protocol focuses on muscle activation strategies through a variety of movements, including muscle stretching/contraction. The protocols require participants to consciously involve certain muscle groups in various movements in order to work all major muscle groups and increase physical endurance in general.

Sample size and population: The results obtained in experimental group I (t-shirts containing cFIR) and in experimental group II (placebo t-shirts) were compared. It is assumed that the acceptable number of participants required to provide α=0.05 with a power of 0.95, will be only 62 subjects distributed between two experimental groups (31 subjects in each group). The required number of subjects was calculated using G*power Statistical Power Analyzes version 3.1 (Heinrich-Heine-Universitat Diisseldorf, Germany) as follows.

Analysis: A priori.

Inputs: effect size f=0.35/a, error rate=0.05/Power (1-β error probability)=0.95/number of groups=2/number of measurements=9/correlation between repeated measurements=0, 5.

Output data: non-centrality parameter λ=13.6710000/Critical F=4.0011914/enumerator df=1.0000000/Denominator df=60.0000000/total sample size=62/actual power=0.9532935.

Randomization: Participants were randomly assigned to each group. The researcher generates random numbers using the Research Randomizer software. These numbers will be stored on the computer and will only be available to the assistant. No stratification or blocking strategies will be used.

Estimated number and frequency of evaluations: Baseline evaluation is performed before study entry and then every week for a total of six weeks (minimum).

Measured study endpoints.

A) Functional endurance:

Balance: The static balance of each human subject was measured by a stabilometric exam using a stabilometric pressure plate (Medicapteurs®, model S-Plate®). The platform records deviations of the center of pressure (COP) in the anteroposterior and mediolateral directions. Data is received within 30 under the following conditions:

condition 1: the human subject keeps his eyes open during measurements;

Condition 2: The human subject keeps his eyes closed during measurements.

Cardiorespiratory endurance: The oxygen consumption (VO ₂ ) of each human subject was calculated using a regression equation as described by King et al. (J. Rheumatol. 1999; 26:2233-7).

B) Body composition:

Body mass index, fat mass index, skeletal muscle mass index, body fat percentage were calculated using bioimpendancemetry (BIA).

C) The ability of human subjects wearing bioceramics to emit far-infrared radiation:

Human subjects were photographed before, during and after the training protocol using an infrared thermographic camera (Flir E6 IR camera, FLIR Systems, Inc). Far infrared images were used to determine changes in body temperature caused by cFIR emissions and/or physical activity.

D) The ability of bioceramic T-shirts and other body wear items to emit far infrared radiation:

The emissivity of the T-shirts was measured using an Astral Series S Calorimeter AC2500S calorimeter connected to a hand-held measuring device (Astral AI310 (Scientech, Boulder, CO, USA). Assessments were performed before and after participants completed the training protocol (Pilates class) Assessments can be performed during training.

E) Blood/saliva samples are collected for biochemical analyzes (muscle stress markers/inflammatory markers/oxidative stress markers):

Muscle stress markers: creatine kinase (CK) and lactate dehydrogenase (LDH).

Inflammatory markers: interleukin IL-10, IL-6, II.-1 β and tumor necrosis factor TNF-α.

Oxidative stress: thiobarbituric acid reactive substances (TBARS), carbonylated proteins, catalase (CAT) and superoxide dismutase (SOD).

F) Questionnaires:

The following questionnaires are used to obtain an individual score from each subject:

a) modified Borg Scale of Perceived Exertion (RPE);

- 41 041903

b) Pittsburg sleep quality index (PSQI);

c) WHO Quality of Life-BREF (WHOQOL-BREF).

Example 32 Comparison of a bioceramic according to the invention with another bioceramic composition incorporated into an UnderArmour Cold Gear T-shirt.

Objective: Comparison of the analgesic effect of a bioceramic according to the invention with a far infrared (cFIR) emitting bioceramic composition obtained from UnderArmour™ (UA) in a mouse model of CFA-induced mechanical hypersensitivity. The mouse model of CFA is further described in Examples 15, 16 and 18.

Evaluation of mechanical hypersensitivity: Experiments were performed using adult male Swiss mice weighing 25-35 g housed at 22°C under a 12 h light/12 h dark cycle (lights on at 6:00), with ad libitum access to food and water. Animals (n=8) were subjected to an intraplantar injection (right hind leg) with a solution containing 20 μl of complete Freund's adjuvant (CFA, 70%) to induce mechanical hypersensitivity.

For treatment, a screen-printed cloth containing a far-infrared emitting bioceramic of the invention or an UnderArmour™ trademark formulation was placed at the bottom of the animal boxes. After 2 hours of exposure to bioceramics, the mechanical nociceptive threshold of each animal was assessed as the frequency of responses to 10 applications of 0.4 g of von Frey thread on the right hind paw of the animals.

Results: CFA-induced mechanical hypernociception in mice was significantly reduced after exposure to tissue containing bioceramic according to the invention, while the bioceramic contained about 40 to 60 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ ), about 5 to 15 wt.% tourmaline, about 15 to 25 wt.% alumina (Al ₂ O ₃ ), about 10 to 20 wt.% silicon dioxide (SiO ₂ ) and about 1 to 20 wt.% zirconia (ZrO ₂ ). CFA-induced mechanical hypernociception in mice was not reduced after exposure to tissue containing the bioceramic formulation described by UnderArmour™. The analgesic effect lasted up to 2 hours.

In FIG. 24 is a graph illustrating the analgesic effect of a far infrared emitting bioceramic (cFIR) of the invention compared to an UnderArmour™ formulation in a CFA-induced mechanical hypersensitivity mouse model. N=8 mice per group, vertical lines represent S.E.M. *p<0.05.

Conclusion: The bioceramic according to the invention reduced the mechanical hypersensitivity induced by injection of CFA into the paw, while the other formulation did not provide an analgesic effect.

Example 33 Transmission of infrared radiation by bioceramics.

The purpose of the study: to compare the infrared transmission of the bioceramic according to the present invention (containing 18% alumina, 14% silica, 50% kaolinite, 8% zirconium oxide and 10% tourmaline) with another bioceramic composition (containing 20% aluminum, 3% titanium, 11% magnesium oxide, 6% diiron trioxide and 60% silicon).

Methods: The infrared transmission of powder samples (particle size = about 25 μm) was measured using a Bruker spectrometer (Model Spectrum VERTEX 70, OPUS 6.5 software). Transmittances (%) were determined with a resolution of 4 cm ^-1 and 72 scans in the scan range from 350 to 4000 cm ^-1 .

In FIG. 25A shows the infrared transmission of a bioceramic composition of the present invention containing 18% alumina, 14% silica, 50% kaolinite, 8% zirconia and 10% tourmaline.

In FIG. 25B shows the infrared transmission of a bioceramic composition containing 20% aluminium, 3% titanium, 11% magnesium oxide, 6% diiron trioxide and 60% silicon.

Example 34 Effect of Far Infrared Emitting Bioceramic Body Worn Article on Fibromyalgia in Human Subjects Receiving Hydrotherapy.

Objective of the Study: To investigate the effect of a far-infrared emitting bioceramic body-worn article on the following parameters of human subjects with fibromyalgia: a) heart rate; b) ability to tolerate functional exercise, c) balance, d) overall level of subjective pain, e) questionnaires related to the impact of 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 anti-inflammatory enzyme activity.

Study design: Double-blind, placebo-controlled study.

Experimental part: Participants followed a hydrotherapy regimen 3 times a week for 6 weeks and were divided into two different groups (placebo and bioceramic). Subjects in the placebo group wore mock body-worn items, ie. human subjects wore T-shirts that did not have far-infrared emitting properties

- 42 041903 (t-shirts not containing bioceramics). Subjects in the bioceramic group wore bioceramic-containing T-shirts every night during sleep (6 to 8 hours) for 6 consecutive weeks, as well as during hydrotherapy sessions. Each hydrotherapy session consisted of four phases, namely: (1) warm-up: participants were asked to walk back and forth along the pool; (2) active stretching of the upper and lower extremities; (3) active exercises for the upper and lower extremities; and (4) relaxation exercises through oscillatory movements. All phases were conducted under the guidance of a therapist.

Sample size and population: 16 participants: 8 females in each group, evenly distributed by age. All participants were female.

Assessments: Assessments were made to determine the following parameters and endpoints: flexibility, grip strength, heart rate, pain, performance, and functional exercise capacity. The results listed below represent data from 6 consecutive weeks of assessments:

A) Heart rate: A heart monitor was used to assess the flexibility of human subjects. Number of evaluations: the initial evaluation was carried out before the start of testing. Follow-up assessments were made before and after each hydrotherapy session (3 times a week for 6 weeks). The results of this test are shown in Fig. 26 and are described below.

B) Functional exercise capacity: To assess the functional exercise capacity of human subjects, a 6-minute walking test (6MWT) was used, measuring the distance that an individual is able to walk in 6 minutes on a hard, flat surface. Number of evaluations: Baseline evaluation was performed before the start of testing and 6 weeks after the start of testing. The results of this test are shown in Fig. 26 and are described below.

In FIG. 26 is a graph illustrating the effect of a far infrared emitting body wear item on heart rate and exercise capacity of human subjects afflicted with fibromyalgia who followed a hydrotherapy treatment regimen. Baseline assessments were performed once a week before any intervention. In FIG. 26, panels A and B, show the cumulative effect of a far-infrared emitting body-worn article on heart rate over a period of 6 weeks before and after hydrotherapy, respectively. In FIG. 26, panel C, shows functional exercise capacity as total distance traveled in meters in 6 min. Baseline assessments were performed once a week prior to any intervention. *p<0.05 indicates a statistically significant difference between groups (paired t-test at 95% confidence interval - Graphpad Prism software, USA, 2014).

C) Balance: A stabilometric/baropodometric platform (S-Plate - Medicapteurs, France) was used to assess the balance of human subjects. Number of evaluations: Baseline evaluation was performed prior to testing and subsequent evaluations were performed after 6 weeks of treatment. In FIG. 27 is a graph illustrating the effect of a far-infrared emitting bioceramic body-worn article on the balance of fibromyalgia patients who followed a hydrotherapy treatment regimen. Fig. 27 demonstrates that hydrotherapy in combination with the use of a control body wear did not affect the balance of the subjects, while the use of a far infrared emitting bioceramic statistically reduced latero-lateral vibrations. In FIG. 27 shows the cumulative results obtained over a period of 6 weeks. *p<0.05 means statistically significant difference between groups (paired t-test at 95% confidence interval - Graphpad Prism software, USA, 2014).

D) Overall Level of Subjectively Assessed Pain: The Visual Analogue Scale (VAS) was used to assess pain levels. Number of evaluations: the initial evaluation was carried out before the start of testing. Follow-up assessments were made before and after each hydrotherapy session (3 times a week for 6 weeks). *p<0.05 means a statistically significant difference between groups. Baseline assessments were performed once a week before any intervention (paired t-test with 95% confidence interval - Graphpad Prism software, USA, 2014). In FIG. 28 is a graph illustrating the effects on the overall level of subjective pain of human subjects affected by fibromyalgia who were treated with a far infrared emitting body wear or dummy body wear. Based on the results shown in FIG. 28, it can be hypothesized that (1) hydrotherapy in combination with the use of a simulated body wear or body wear containing bioceramics reduces the overall levels of subjective pain in patients (comparison of baseline with levels before and after therapy for each groups - statistical significance not shown in the figure); (2) the results suggest a long-term effect (cumulative) of the combined treatment.

E) Questionnaires related to the impact of fibromyalgia, pain, quality of life and general condition

- 43 041903 health: The Fibromyalgia Impact Questionnaire (FIQ), the McGill pain questionnaire and the McGill descriptors index, and the SF-36 questionnaire (physical functioning, pain and general index) were used to evaluating the effects of far-infrared-emitting bioceramics on fibromyalgia, pain, quality of life, and other health-related aspects. Number of evaluations: Baseline evaluation was performed before the start of testing and after 6 weeks. In FIG. 29A is a graph illustrating the results of the Fibromyalgia Impact Questionnaire (FIQ) (panel A), the McGill Pain Inventory (panel B), and the McGill descriptors index (panel C). *p<0.05 and **p<0.01 mean a statistically significant difference between groups. Baseline assessments were performed once a week before any intervention (paired t-test at 95% confidence interval - Graphpad Prism software, USA, 2014).

The results shown in FIG. 29A indicate that (1) hydrotherapy combined with placebo (sham) T-shirts or bioceramic T-shirts has a positive effect on FIQ scores, but far-infrared emitting bioceramic T-shirts combined with hydrotherapy is more effective than hydrotherapy alone (placebo T-shirts); (2) the use of only bioceramic T-shirts statistically affects the McGill pain index and descriptors. It should be noted that the lower the score, the better the result. In FIG. 29B is a graph illustrating the results of the SF-36 questionnaire; physical functioning (panel A), pain (panel B) and general index (panel C). Baseline assessments were performed once a week before any intervention (paired t-test at 95% confidence interval - Graphpad Prism software, USA, 2014). The results shown in FIG. 29B indicate that hydrotherapy combined with placebo T-shirts or far-infrared-emitting bioceramics has a positive effect on pain in the SF-36 questionnaire as well as the overall index, while the use of bioceramic T-shirts has a statistical effect on scores on all three rating scales. It should be noted that the scores of the rating scales can vary from 0 to 100, and the lower the score, the worse the prognosis.

F) Blood levels of inflammatory and anti-inflammatory cytokines. Enzyme immunosorbent assay (ELISA) was used to assess blood levels of inflammatory and anti-inflammatory cytokines. Number of evaluations: the initial evaluation was carried out before the start of testing. Follow-up assessments were made before and after each hydrotherapy session (3 times a week for 6 weeks).

G) Blood levels of markers of oxidative stress and activity of antioxidant enzymes. Enzyme immunosorbent assay (ELISA) was used to assess blood levels of inflammatory and anti-inflammatory cytokines. Number of evaluations: the initial evaluation was carried out before the start of testing. Follow-up assessments were made before and after each hydrotherapy session (3 times a week for 6 weeks).

Example 35 Effect of a far-infrared emitting bioceramic body-worn article on the postural swing of judokas.

Research rationale: Postural control is defined as the control of the body's position in space for the purposes of balance and orientation. Postural stability/balance is an important component in evaluating the effectiveness of interventions to improve balance.

Objectives of the study: To determine the effects of fabrics impregnated with ceramic material emitting radiation in the far infrared spectrum on the postural oscillation of university judokas.

Study design: Single-blind, randomized, placebo-controlled study. 17 male and female volunteers who were randomly assigned to the experimental group (the cFIR group consisting of 4 male wrestlers and 4 female wrestlers who were asked to wear T-shirts impregnated with FIR-emitting ceramic material for five months); and a control group (a non-cFIR group consisting of 5 male wrestlers and 4 female wrestlers who were asked to wear sham/placebo T-shirts, i.e. not impregnated with cFIR-emitting ceramic material). Randomization numbers were generated on the randomization website (randomization.com).

Participants: A total of 17 judokas (nine men and eight women) participated in this study. The following inclusion criteria were considered: (1) each human subject takes part in official judo competitions during the calendar year; (2) each human subject works out at least three times per week; (3) each human subject is between 18 and 35 years of age; (4) each human subject has been practicing judo for at least 10 years. The following exclusion criteria were considered: (5) Individuals with a history of musculoskeletal injury to the hip, knee, or ankle in the previous 2 months; subjects who have taken pharmacological agents or nutritional supplements; those with a musculoskeletal injury during the study or who did not wear a T-shirt for at least 4 hours per day were excluded from the study. All participants took part in the competition

- 44 041903 national level.

Bio-ceramic and body wear: The experimental group wore T-shirts impregnated with FIR-emitting bio-ceramic material. The bioceramic material was mixed with textile ink (Silkscreen Plastisol, Imagine Color, Brazil) and applied to a bioceramic item for body wear, i. t-shirts. Bio-ceramic inks were used to screen-print a repeating pattern onto a 92% polyester, 8% spandex fabric that had previously been used to impregnate bioceramic T-shirts. Simulated T-shirts were screen printed with the same pattern but using 100% plastisol ink (no far infrared emitting ceramic powder). The average absolute emissivity of the ceramic powder was 93% at wavelengths of 9-11 µm, determined using a Scientech calorimeter (Boulder, CO, USA), Astral model S AC2500S series, connected to a Scientech Astral model S AI310D detector unit. The control group wore a placebo T-shirt (no FIR-emitting ceramic material).

Experimental: Participants were instructed by the researcher, who had no information about the treatments, to wear one of the T-shirts for 4 hours daily during practice (which included aerobic training, weight lifting and combat classes) throughout the experiments. The experiment lasted for 5 months with daily use of bioceramic T-shirts (4 hours during practice). Static balance (stabilmetry) was assessed before and after the experiment. The training protocol consisted of 2 hours of fitness in the morning and 2 hours of tatami-specific technical training in the daytime, 5 days a week. In FIG. 30 shows a flowchart describing the procedure for conducting the study.

Study Endpoints: Advances in technology have provided the scientific community with computerized platform systems for quantifying static balance. These systems provide an easy, practical and low cost way to quantify functional balance through postural swing analysis. Such systems record displacement from the center of foot pressure (COP) using sensors built into the platform structure. COP movements reflect the position of the center of gravity (COG) horizontally, as well as the load on the supporting surface due to the muscular activity of the lower limb, transmitted through the foot. Postural oscillation can be measured as a sustained oscillation of the center of mass (COM) along the anterior-posterior (AP) and mid-lateral (ML) axes.

Statistical analysis: For statistical analysis, the Kolmogorov-Smirnov test was used to determine that the sample had an appropriate distribution, using a parametric test to analyze data obtained from pressure plate testing. Paired and unpaired t-tests were used for intragroup and intergroup comparisons, respectively. GraphPad prism software (version 5.0, Mac OS) was used for statistical analysis with a significance level set at 5% (p<0.05).

Results: Total length and area of displacement from the center of pressure (COP) decreased significantly after treatment in the experimental group with varying degrees of reduction with eyes open (p<0.05) but not with eyes closed (p>0.05). In addition, the experimental group demonstrated a reduction in mid-lateral and postero-anterior deviations (width) from COP after treatment in the open-eye analysis.

Analyzes were performed on 25 participants (FIG. 30). Anthropometric characteristics of the participants are presented in Table. 1. There is no statistically significant difference between groups in terms of individual characteristics.

Table 1

Groups Control experimental Individual(s) 9 8 Age (years) 21.4±2.6 22.3±4.3 Body weight (kg) 80.2 ± 28.2 79.5±25.8 Height (m) 1.74±0.1 1.69±0.0 BMI (kg/ ^m2 ) 25.7±6.3 27.5 ± 7.4 Men/women tires 5/4 4/4 Duration of training (years) 10.5±4.1 12.1±4.4

In FIG. 31 is a graph illustrating the effect of a far-infrared emitting body-worn article on postural control. In FIG. 31 shows the results of variables before and after FIR-placebo or FIR treatment, with values presented as mean and standard deviation. The total length and area of deviation from COP decreased after treatment in the experimental group, with varying degrees of reduction when

- 45 041903 eyes were open (p<0.05) but not closed (p>0.05). There was no reduction in body displacement in the control group after placebo treatment with open and closed eyes (p>0.05). These findings demonstrate that exposure to FIR results in less body deflection and therefore greater orthostatic control.

In addition, as shown in Table. 2, the experimental group showed a reduction in mid-lateral and antero-posterior deviations (width) from COP after treatment in the open-eye analysis, thus demonstrating higher orthostatic control, while no significant difference was found in the control group (p>0.05) . Analysis of the average speed of the median-lateral and antero-posterior deviations did not reveal statistically significant differences between the groups (p>0.05).

table 2

Eyes open analysis

Control group Experimental group Deviation Before After Before After Mid-lateral - width (mm) 4.750±2.308 7.060±2.092 4.310±2.617 4.500±1.619* Mid-lateral - average speed (mm/sec) 1.100±0.2160 1.300±0.2280 1.010±0.1853 1.1 17±0.0408 Front-back - width (mm) 5.350±2.178 6.633±2.181 4.250±2.611 4.217±1.333* Anterior-posterior - average speed (mm/sec) 1.200±0.673 1.583±0.879 1.040±0.607 0.950±0.314

In table. 3 shows that FIR treatment did not affect orthostatic control for mid-lateral and antero-posterior deviations across all analyzed parameters in human subjects with eyes closed (width and mean speed) compared to placebo-FIR.

Table 3

Eyes closed analysis

Control group Experimental group Deviation Before After Before After Mid-lateral - width (mm) 3.522±2.228 3.533±2.856 3.b30±2.412 4.350±1.773 Mid-lateral - average speed (mm/sec) 0.960±0.23 1 1.217±0.337 0.910±0.213 1.000±0.281 Front-back - width (mm) 4.556±4.005 4.183±3.056 3.0±1.272 4.133±1.475 Anterior-posterior - medium speed (mm/sec) 1.200±1.715 1.467±1.480 0.790±0.568 О,85О±О,ЗО1

Conclusion: These findings indicate that exposure to FIR results in less body sway and therefore greater orthostatic control. The results obtained here suggest that FIR garments may have practical clinical applications for balance disorders or as a performance-enhancing garment for body wear in both daily activity and competitive sports.

Example 36 Effect of a Far Infrared Emitting Bioceramic Body Worn Article on Human Subjects Exercising Pilates.

Objectives of the study: To study the effect of a far-infrared emitting bioceramic body-worn object on flexibility, grip strength, balance, heart rate variability and sleep quality.

Study design: Double-blind, placebo-controlled clinical trial.

Experimental: Participants followed a Pilates beginner protocol of one hour, three times a week for eight weeks, and were randomly assigned to two different groups (placebo and bioceramics). The placebo group wore a t-shirt simulating a far-infrared emitting ceramic t-shirt (without bioceramics), while the bioceramic group wore a bioceramic t-shirt that emitted far-infrared radiation for 8 weeks every night during sleep (from 6 to 8 hours).

clinical measurements.

Sample size and population: 30 participants: 15 individuals in each group. Even distribution by sex/age.

Flexibility: The sit-and-reach bench test was used to measure flexibility. Baseline assessment was performed before testing and before each Pilates session (3 times a week for 8 weeks). Grip strength: A hand dynamometer was used to measure grip strength. Baseline assessment was performed prior to the start of pre-Pilates testing (3 times per week for 8 weeks). Balance: balance was assessed using a stabilometric/baropodometric platform (S-Plate - Medicapteurs, France). Baseline assessment was performed before testing and after six weeks.

In FIG. 32 is a graph illustrating the effect of a far-infrared emitting bioceramic body-worn article on the flexibility and grip strength of Pilates practitioners. Baseline assessments were performed once a week prior to any intervention. *p<0.05 when compared with baseline score (paired t-test with 95% confidence interval - Graphpad Prism software, USA, 2014). The results shown in FIG. 32 indicate that the use of bio-ceramic T-shirts in combination with Pilates training statistically increased the flexibility and grip strength of the participants.

In FIG. 33 and 34 are graphs illustrating the effect of a far-infrared emitting bioceramic body-worn article on the stabilometry of Pilates practitioners.

In FIG. 33 is a graph illustrating the effect of a far-infrared emitting bioceramic body-worn article on the stabilometry (latero-lateral) of Pilates practitioners: length in the latero-lateral direction (Panel A), distance in the latero-lateral direction (Panel B) , speed in the latero-lateral direction (panel C).

In FIG. 34 is a graph illustrating the effect of a far infrared emitting bioceramic body-worn article on stabilometry (anterior-posterior) in Pilates practitioners: length in anterior-posterior direction (panel A), distance in anterior-posterior direction (panel B ), speed in anterior-posterior direction (panel C). *p<0.05 means a statistically significant difference between groups.

Baseline assessments were performed once a week before any intervention (paired t-test with 95% confidence interval - Graphpad Prism software, USA, 2014). The results shown in FIG. 33 and 34 indicate that the use of bioceramic T-shirts in combination with Pilates training statistically reduced the anterior-posterior oscillations - total length, distance from the center and speed, while the use of placebo T-shirts statistically influenced (to a lesser extent) the total length and distance from the center.

Heart rate variability (HRV): Heart rate was assessed using the Nerve-Express unit (Valley Stream, NY, USA). Baseline assessment was performed before testing and after eight weeks. In FIG. 35 shows the effect of far-infrared-emitting clothing on heart rate variability (HRV) in Pilates practitioners. Heart rate variability was assessed using the Nerve-Express unit (Valley Stream, NY, USA). The results shown in FIG. 35 indicate that the use of far infrared emitting bioceramic T-shirts increases rMSSD and HF (High Frequency Power) and also decreases LF (Low Frequency Power). The combination of these findings indicates an overall increase in parasympathetic autonomic nervous system activity and a decrease in sympathetic branch activity. (In this case, an increase in parasympathetic activity and a decrease in sympathetic activity indicate a more favorable outcome.) RMSSD (square root mean square difference between adjacent NN intervals): commonly used as a measure of vagus (vagus nerve) mediated cardiac control that detects respiratory sinus arrhythmia (RSA), changes in heart rate in response to breathing. RMSSD is a recognized measure of parasympathetic activity and correlates with HF frequency spectrum analysis. High Frequency Power is a marker of parasympathetic activity. Low Frequency Power is a marker of both parasympathetic and sympathetic activity.

Sleep Quality: Sleep quality was assessed using The Pittsburgh Quality of Sleep Questionnaire. The assessment of the initial state was carried out before the start of testing and after 8 weeks. In FIG. Figures 36 and 37 show the results of the Pittsburgh Quality of Sleep Questionnaire. *p<0.05 when compared to baseline (paired t-test with 95% confidence interval - Graphpad Prism software, USA, 2014). Several parameters were assessed, including daytime dysfunction (Fig. 36, panel A), sleep quality (Fig. 36, panel B), sleep efficiency (Fig. 36, panel C), sleep duration (Fig. 37, panel A), disturbance sleep (FIG. 37, panel B) and the PQSI questionnaire (FIG. 37, panel C).

Results: The results shown in FIG. 4 indicate that the use of far infrared emitting bioceramic T-shirts reduces the following indices (a lower index means 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 Quality of Sleep Questionnaire: minimum score = 0 (best); maximum score = 21 (worst).

Conclusion: Wearing far-infrared T-shirts during sleep increases sleep duration and efficiency, increases parasympathetic nervous system activity, and decreases sympathetic nervous system activity, which may be associated with more relaxed and better sleep. Studies have shown that far infrared (FIR) radiation emitted by bioceramics promotes microcirculation (A), causes a reduction in muscle fatigue (B), reduces the effects of stress (C), and promotes analgesia and reduces inflammatory conditions (D); it is possible that the combination of these effects results in more relaxed and efficient sleep.

Example 37 Effect of Far Infrared Clothing on Weight Loss, Body Shape Change and Cellulite Reduction.

Objectives of the study: To study the effect of shorts containing bioceramics on weight loss, changes in body parameters and cellulite reduction.

Study type: Randomized, double-blind, placebo-controlled. Women were randomly assigned to the experimental group (cFIR group, participants were asked to wear shorts impregnated with FIR-emitting ceramic material); and a control group (control group, participants were asked to wear shorts impregnated with imitation ceramic material, i.e. ceramic material that did not provide far infrared radiation energy). Randomization numbers were optionally generated from a randomization website (randomization.com).

Materials and Methods: Thirty healthy adult women with moderate to severe cellulite (on a cellulite scale of at least II of IV) assessed by the Investigator Therapist were randomly assigned to either an experimental or control group (15 participants in each group). Participants had no information about which group they were enrolled in. Participants wore shorts daily for at least 6 hours a day for 6 weeks.

Exclusion criteria include the following participants:

participants who received treatment to reduce cellulite on their thighs one month prior to study entry;

participants with a history of deep vein thrombosis in the past two years;

participants with a history of congestive heart failure;

participants who were diagnosed with an occlusive lesion of a leg artery;

pregnant and lactating women;

participants who used topical medications (eg, corticosteroids) in the two weeks prior to study entry.

Estimated parameters: Initial, i.e. baseline, body weight, cellulite, and body parameters were measured for each participant prior to study entry. Subsequent measurements were taken approximately every two weeks from the first day of the study.

Specific measured parameters include:

weight or body mass index (BMI: weight, in kilograms, divided by height squared, in meters);

hip circumference. Measuring hip circumference at fixed points using a centimeter can give an indirect measure of localized fat and is possibly related to cellulite. Thigh circumference measurements are carried out on both legs at a distance of 18 and 26 cm from the upper pole of the patella and upper thigh, respectively, using a centimeter;

cellulite examination. Direct or photographic examination of skin irregularities such as wrinkling, dimples, and bumpiness is used to assess cellulite levels. The examiner takes high quality color digital images of the posterior and lateral sides of the thighs from the following angles:

(a) right thigh at 90°, (b) right thigh at 45°, (c) right thigh at 180°, (d) both thighs at 90°, (e) left thigh at 90°, (f) left femur at 45°, (g) left femur at 180°.

The photographs are reviewed by five independent, Ministry of Health-certified dermatologists with no information on treatments;

skin elasticity. Measuring skin tension with an elastomer (suction elastometer) can evaluate the elasticity of the dermis, connective tissue function, helping to measure the amount of cellulite present;

- 48 041903 electrical conductivity of the skin. Electrical conductivity was used to measure tissue resistance to electron flow and to determine a specific body composition percentage (lean mass, fat mass, water).

Example 38 Effect of far infrared bioceramic clothing on muscle recovery and delayed muscle soreness syndrome.

Research objectives: To study the effect of bioceramic trousers (shorts) on muscle recovery after a muscle injury protocol (strength), delayed muscle soreness syndrome, blood levels of CK (creatine kinase) and LDH (lactate dehydrogenase), blood levels of inflammatory and anti-inflammatory cytokines (TNF-α , IL-6, Ι.-1β, IL-10 and IL-4) and blood levels of markers of oxidative stress, as well as the activity of antioxidant enzymes (TBARS carbonyls, superoxide dismutase (SOD) and catalase).

Study type: Double-blind, placebo-controlled clinical trial.

Experimental: Subjects were randomly assigned to two groups (placebo and bioceramics). Subjects in the placebo group wore sham trousers (without bioceramics), while participants in the bioceramics group wore trousers containing far infrared emitting bioceramics. Subjects in both groups wore pants for 2 hours immediately after the start of the injury protocol (day 0). Subjects also wore pants for longer periods of time starting on day 1 (24 hours after the start of the muscle injury protocol), day 2 (48 hours after the start of the muscle injury protocol), and day 3 (72 hours after the start of the muscle injury protocol).

Ratings:

a) Muscle recovery after a muscle injury protocol: quadriceps strength was assessed using isokinetic equipment (De Queen, AR, USA). Baseline assessments were made before testing, immediately after the muscle injury protocol, and on days 1, 2, and 3 (after wearing trousers).

b) Delayed muscle soreness syndrome was calculated using a visual analogue scale (VAS) estimating the intensity of pain. Baseline assessments were made before testing, immediately after the muscle injury protocol, and on days 1, 2, and 3 (after wearing pants).

c) Blood levels of CK (creatine kinase) and LDH (lactate dehydrogenase), inflammatory and anti-inflammatory cytokines (TNF-α, IL-6, Π.-1β, IL-10 and IL-4), markers of oxidative stress and antioxidant enzyme activity ( carbonyls TBARS, SOD and catalase) were measured using biochemical assays (ELISA). Measure baseline exercise before testing, immediately after muscle injury protocol, and on days 1, 2, and 3 (after wearing trousers).

Sample size and population: 30 participants: 15 individuals in each group. Even distribution by sex/age.

Example 39 Evaluation of biomodulation induced by the use of infrared emitting ceramic t-shirts in patients with chronic obstructive pulmonary disease (COPD).

Study Objectives: This study evaluates the biomodulatory effects induced by the use of cFIR-impregnated T-shirts in patients with chronic obstructive pulmonary disease (COPD). COPD is defined as chronic and progressive airflow limitation associated with an impaired inflammatory response in the lungs. One of the hallmarks of COPD is a decrease in aerobic endurance and muscle strength, resulting in loss of functionality and exercise intolerance, with a negative impact on the patient's quality of life.

Inclusion Criteria: Subjects of both sexes diagnosed with COPD were selected according to the following criteria: clinical diagnosis of COPD and age (subjects over 40 years of age).

Exclusion Criteria: Current disabling comorbidity and/or exacerbation of COPD within the last 6 months.

T-shirts impregnated with BioPower® bioceramics were used for the treatment. Participants wore T-shirts at night (6-8 hours) for 3 consecutive weeks. Assessments were made before and after treatment. A modified Medical Research Council Dyspnoea Scale (mMRC) was used to classify the functional clinical status of each patient. Functionality was assessed using the London Chest Activity of Daily Living scale (LCADL) and the 6-minute walking test (6MWT). The activity of the autonomic nervous system was assessed using the analysis of heart rate variability. 13 patients were selected and 3 patients withdrew from the study. Thus, the sample consisted of 10 COPD individuals with a mean age of 63.70 years, a mean BMI of 26.19 kg/m ² , and a smoking history of 24.41 years/pack. 40% of the sample were women and 60% men.

- 49 041903

Analysis using the LCADL questionnaire showed that patients experienced a statistically significant improvement (p<0.01) compared to their pre-treatment conditions (FIG. 38). In pre-treatment analyses, patients had a mean proportion of total scores of 42.88% and 40.36% in post-treatment analyses.

In the 6MWT test, using the reference BMI in Equation 1, patients showed an increase of 5.37% of the predicted distance. In FIG. 39 shows the results of the 6MWT (Performance-based functional exercise capacity test) with equation 1 (panel A), equation 2 (panel B), and distance walked before and after treatment (panel C). Columns represent mean values from 10 patients and vertical lines correspond to standard error of the mean (SEM). **P<0.01 when comparing the state before and after treatment (paired t-test). This data is confirmed by the analysis of equation 2 (using AHR in the comparison equation), in which the increase is 8.32% of the predicted distance. In addition, the results showed an increase of 36 m compared with the assessment before treatment.

In FIG. 40 shows the results of changes in heart rate (frequency domain) of COPD patients assessed before and after treatment. (Panel A) low frequency (ms ² ), (panel B) low frequency (nu), (panel C) high frequency (ms ² ), (panel D) high frequency (nu). Columns represent mean values from 10 patients and vertical lines correspond to standard error of the mean (SEM). ** P<0.01 when comparing the state before and after treatment (paired t-test).

In FIG. 41 shows the results of changes in heart rate (time domain) of COPD patients assessed before and after treatment. (Panel A) RR intervals, (panel B) HR intervals, (panel C) SDNN component, (panel D) rMSSD. Columns represent mean values for 10 patients and vertical lines correspond to standard error of the mean (SEM). **P<0.01 when comparing the state before and after treatment (paired t-test).

Heart rate fluctuation analyzes showed a reduction in low-frequency parameters, indicating a decrease in sympathetic nervous system activity. Based on these data, it can be concluded that far infrared treatment with cFIR-impregnated T-shirts increased exercise capacity, reduced daily restrictions, and decreased sympathetic nervous system activity in patients with COPD.

Example 40 Evaluation of the effect of far-infrared-emitting ceramic T-shirts on oxygen consumption, heart rate, and sleep quality: a randomized, double-blind, placebo-controlled clinical trial in young baseball players.

Research Objectives: This study investigates the effect of far-infrared-emitting ceramic T-shirts on oxygen consumption, heart rate, and sleep quality.

Study design: Double-blind, placebo-controlled clinical trial.

Experimental: Participants were randomly assigned to two different groups (placebo and Biopower). The Biopower group wore far-infrared-emitting Biopower-branded ceramic T-shirts (with bio-ceramic), while the placebo group wore a fake T-shirt (with bio-ceramic) for 6 weeks every night during sleep (6 to 8 hours).

Ratings:

a) Initial VO2 intake;

b) maximum oxygen uptake (VO _2max );

c) aerobic threshold (AeT);

d) anaerobic threshold (AnT);

e) heart rate (initial, at VO _2max , AeT and AnT);

f) sleep quality.

Oxygen consumption and heart rate assessments were performed using CardioCoach (VO ₂ estimator - KORR Medical Technologies, Salt Lake City, UT, USA). Sleep quality was assessed using the Pittsburgh Quality of Sleep Questionnaire. All participants were assessed before testing (baseline) and after 6 weeks.

Sample size and population: 30 participants: 15 individuals in the control group (sham T-shirts) and 15 individuals in the experimental group (bioceramic T-shirts). All participants were healthy male baseball players.

In FIG. 42 shows initial VO2 intake results for young baseball players: Panel A shows initial VO2 intake. Panel B shows the percentage of participants with the highest initial VO2. Panel C shows the starting heart rate and panel D shows the percentage of participants with the lowest heart rate. Each column represents the average of 12-15 participants, and the vertical lines indicate S.E.M. NS means not statistically significant (t-test with 95% confidence interval - Graphpad Prism software, USA, 2014). The results shown in FIG. 42, panel A, suggest that the use of bioceramic T-shirts increases initial VO2 intake in a non-statistically significant manner.

In FIG. 43 shows the results of the maximum intake of VO _2max by young baseball players: panel A shows VO _2max , and panel B shows the percentage of participants with the highest VO _2max . Panel C shows the subjects' heart rate at VO _2max and panel D shows the percentage of participants with the lowest heart rate at VO _2max . Each column represents the mean of 12-15 participants, and vertical lines indicate SEM NS means not statistically significant. *p<0.05 when compared to baseline (t-test with 95% confidence interval - Graphpad Prism software, USA, 2014). Fig. 43, panel C, suggests that the use of bioceramic T-shirts reduces heart rate at VO2max. In addition, a higher percentage of subjects in the bioceramic T-shirt group showed higher VO2max and lower heart rate than the placebo group (BD panels) compared to baseline. The results for each group were obtained when measured after 6 weeks.

In FIG. Figure 44 shows the aerobic endurance threshold results for young baseball players: panel A shows the aerobic endurance threshold (AeT) and panel B shows the percentage of participants with the highest (AeT). Panel C shows the heart rate at AeT and panel D shows the percentage of participants with the lowest heart rate at (AeT). Each column represents the average of 12-15 participants, and the vertical lines represent the S.E.M. NS means not statistically significant. *p<0.05 when compared to baseline (t-test with 95% confidence interval - Graphpad Prism software, USA, 2014). The results shown in FIG. 44, panel C, suggest that the use of bioceramic t-shirts reduces heart rate in AeT subjects. In addition, a higher percentage of participants in the bioceramic T-shirt group showed higher AeT and lower heart rate than the placebo group (panels B-D) compared to baseline. The results for each group were obtained when measured after 6 weeks.

In FIG. Figure 45 shows the aerobic endurance threshold measurements for young baseball players: Panel A shows the aerobic endurance threshold (AnT) and panel A shows the percentage of participants with the highest AnT. Panel C shows the heart rate at AnT, and panel D shows the percentage of participants with the lowest heart rate at AnT. Each column represents the average of 12-15 participants, and the vertical lines indicate the S.E.M. NS means not statistically significant. *p<0.05 when compared to baseline (t-test with 95% confidence interval - Graphpad Prism software, USA, 2014). The results shown in FIG. 44, panel C, suggest that wearing bioceramic T-shirts reduces participants' heart rate at AnT. In addition, a higher percentage of participants in the Biopower group showed a higher AnT value and a lower heart rate compared to the placebo group (panels B-D) when compared to baseline. Measurements were taken after 6 weeks for each group.

In FIG. Figure 46 shows the results of heart rate recovery 1 minute after evaluation of young baseball players: Panel A shows heart rate recovery 1 minute after evaluation, and panel B shows the percentage of participants with the highest percentage of recovery. Panel C shows heart rate recovery 2 min after assessment, and panel D shows the percentage of participants with the highest percentage of recovery. Each column represents the average of 12-15 participants, and the vertical lines indicate the S.E.M. NS means not statistically significant. *p<0.05 when compared to baseline (t-test with 95% confidence interval - Graphpad Prism software, USA, 2014).

In FIG. 47A and 47B show the results of the Pittsburgh Quality of Sleep Questionnaire. Each column represents the average of 12-15 participants, and the vertical lines indicate the S.E.M. NS means not statistically significant. *p<0.05 when compared to baseline (t-test with 95% confidence interval - Graphpad Prism software, USA, 2014). The overall results shown in FIG. 47A and 47B suggest that wearing far-infrared-emitting Biopower ceramic T-shirts statistically reduces the following indices (the lower index is indicative of a more favorable result). Fig. 47B, panel E, sleep latency: minimum score = 0 (best); maximum score = 3 (worst); and fig. 47B, panel F, Pittsburgh Quality of Sleep Questionnaire: minimum score = 0 (best); maximum score = 21 (worst). Differences between the bioceramic group and the control group for FIG. 47A, panels A-C (sleep duration, sleep disturbance, daytime dysfunction) and FIG. 47B, panel A, (daytime dysfunction due to lack of sleep) were not statistically significant.

Although preferred embodiments of the present invention are shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes and substitutions may occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be used in the practice of the invention. It is intended that the following claims define the scope of the invention and that methods and structures falling within the scope of those claims and their equivalents are thereby covered.

Claims (14)

CLAIM 1. A product that provides a biomodulating or physiological effect when heated by the heat of the human body, containing a bioceramic composition, while the bioceramic composition contains: from about 20 to about 80 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ ); from about 1 to about 30 wt.% tourmaline; from about 1 to about 40 wt.% alumina (Al ₂ O ₃ ); from about 1 to about 40 wt.% silicon dioxide (SiO ₂ ) and titanium dioxide (TiO ₂ ), while the amounts are based on the total weight of the bioceramic composition, and while the bioceramic provides concentrated infrared radiation, which provides a biomodulatory or physiological effect when heated by the heat of the human body. 2. The product according to claim 1, characterized in that the bioceramic contains: from about 40 to about 60 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ ); from about 5 to about 15 wt.% tourmaline; from about 15 to about 25 wt.% alumina (Al ₂ O ₃ ); from about 10 to about 20 wt.% silicon dioxide (SiO ₂ ) and titanium dioxide (TiO ₂ ). 3. The product according to claim 2, characterized in that the bioceramic contains: about 50 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ ); about 10 wt.% tourmaline; about 18 wt.% alumina (Al ₂ O ₃ ); about 14 wt.% silicon dioxide (SiO ₂ ) and titanium dioxide (TiO 2 ). 4. An article according to any one of claims 1 to 3, characterized in that the bioceramic contains from about 1 to about 20% by weight of titanium dioxide (TiO ₂ ). 5. The product according to claim 4, characterized in that the bioceramic contains about 8 wt.% titanium dioxide (TiO ₂ ). 6. Product according to any one of claims 1 to 5, characterized in that the bioceramic composition additionally contains a substrate, binder, solvent, polymer, polygel or ink. 7. An article according to any one of claims 1 to 5, characterized in that the proportion of the bioceramic composition is from about 0.01 to about 75% by weight of the total weight of the article. 8. An article according to any one of claims 1 to 3, characterized in that the article is selected from the group consisting of clothing, jewelry, plasters, pads, insoles, bedding, body supports, massage rolls, lotions, soaps, tapes, glassware, furniture, paint, ink, stickers, carpets, mats, food and/or drink containers, drink container covers, hats, shoes, headphones, surfaces, sports surfaces, artificial turf, and combinations thereof. 9. The product according to claim 8, characterized in that the product is a garment. 10. The product according to claim 9, characterized in that the product is a T-shirt, jacket, shorts, trousers or sleeve. 11. A method for producing an article according to claim 1, including combining said article with a bioceramic composition, comprising the following steps: preparation of a bioceramic composition, where the bioceramic composition contains: from about 20 to about 80 wt.% kaolinite (Al2Si2O5(OH)4); from about 1 to about 30 wt.% tourmaline; from about 1 to about 40 wt.% alumina (Al2O3); from about 1 to about 40 wt.% silicon dioxide (SiO2) and titanium dioxide (TiO2), while the amounts are based on the total weight of the bioceramic composition; combining bioceramic composition with a substrate in an amount of 10-50 wt.% to obtain a mixture; applying the mixture to the product and drying the bioceramic mixture on the product. - 52 041903 12. The method according to claim 11, characterized in that the bioceramic contains: from about 40 to about 60 wt.% kaolinite (Al ₂ Si ₂ O5(OH) ₄ ); from about 5 to about 15 wt.% tourmaline; from about 15 to about 25 wt.% alumina (Al ₂ O ₃ ); from about 10 to about 20 wt.% silicon dioxide (SiO ₂ ) and titanium dioxide (TiO ₂ ). 13. The method according to claim 12, characterized in that the bioceramic contains: about 50 wt.% kaolinite (Al ₂ Si ₂ O ₅ (OH) ₄ ); about 10 wt.% tourmaline; about 18 wt.% alumina (Al ₂ O ₃ ); about 14 wt.% silicon dioxide (SiO ₂ ) and titanium dioxide (TiO 2 ). 14. The method according to claim 11, characterized in that the bioceramic mixture is applied to the product by spraying, screen printing, dot application, dipping or bonding solution.