NZ725517B2 - Bioceramic compositions and biomodulatory uses thereof - Google Patents

Bioceramic compositions and biomodulatory uses thereof Download PDF

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Publication number
NZ725517B2
NZ725517B2 NZ725517A NZ72551715A NZ725517B2 NZ 725517 B2 NZ725517 B2 NZ 725517B2 NZ 725517 A NZ725517 A NZ 725517A NZ 72551715 A NZ72551715 A NZ 72551715A NZ 725517 B2 NZ725517 B2 NZ 725517B2
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New Zealand
Prior art keywords
bioceramic
infrared
composition
bioceramics
joules
Prior art date
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NZ725517A
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NZ725517A (en
Inventor
Filho Francisco Jose Cidral
Paula Moreira Francisco De
Steven Midttun
Shannon Vissman
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Multiple Energy Technologies Llc
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Publication date
Application filed by Multiple Energy Technologies Llc filed Critical Multiple Energy Technologies Llc
Priority claimed from PCT/US2015/028910 external-priority patent/WO2015171467A1/en
Publication of NZ725517A publication Critical patent/NZ725517A/en
Publication of NZ725517B2 publication Critical patent/NZ725517B2/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0088Radiating heat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/08Oxides; Hydroxides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/22Boron compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K41/00Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
    • A61K41/0052Thermotherapy; Hyperthermia; Magnetic induction; Induction heating therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M2021/0005Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
    • A61M2021/0016Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus by the smell sense
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M21/00Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
    • A61M21/02Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/0635Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0643Applicators, probes irradiating specific body areas in close proximity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/0635Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0643Applicators, probes irradiating specific body areas in close proximity
    • A61N2005/0645Applicators worn by the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/065Light sources therefor
    • A61N2005/0656Chemical light sources
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/0658Radiation therapy using light characterised by the wavelength of light used
    • A61N2005/0659Radiation therapy using light characterised by the wavelength of light used infrared
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/0658Radiation therapy using light characterised by the wavelength of light used
    • A61N2005/0659Radiation therapy using light characterised by the wavelength of light used infrared
    • A61N2005/066Radiation therapy using light characterised by the wavelength of light used infrared far infrared
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0613Apparatus adapted for a specific treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0613Apparatus adapted for a specific treatment
    • A61N5/0616Skin treatment other than tanning
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0613Apparatus adapted for a specific treatment
    • A61N5/0625Warming the body, e.g. hyperthermia treatment
    • CCHEMISTRY; METALLURGY
    • C04CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04BLIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B2235/00Aspects relating to ceramic starting mixtures or sintered ceramic products
    • C04B2235/70Aspects relating to sintered or melt-casted ceramic products
    • C04B2235/96Properties of ceramic products, e.g. mechanical properties such as strength, toughness, wear resistance
    • C04B2235/9607Thermal properties, e.g. thermal expansion coefficient
    • CCHEMISTRY; METALLURGY
    • C04CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04BLIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B33/00Clay-wares
    • C04B33/02Preparing or treating the raw materials individually or as batches
    • C04B33/04Clay; Kaolin
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M11/00Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with inorganic substances or complexes thereof; Such treatment combined with mechanical treatment, e.g. mercerising
    • D06M11/32Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with inorganic substances or complexes thereof; Such treatment combined with mechanical treatment, e.g. mercerising with oxygen, ozone, ozonides, oxides, hydroxides or percompounds; Salts derived from anions with an amphoteric element-oxygen bond
    • D06M11/36Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with inorganic substances or complexes thereof; Such treatment combined with mechanical treatment, e.g. mercerising with oxygen, ozone, ozonides, oxides, hydroxides or percompounds; Salts derived from anions with an amphoteric element-oxygen bond with oxides, hydroxides or mixed oxides; with salts derived from anions with an amphoteric element-oxygen bond
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M11/00Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with inorganic substances or complexes thereof; Such treatment combined with mechanical treatment, e.g. mercerising
    • D06M11/32Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with inorganic substances or complexes thereof; Such treatment combined with mechanical treatment, e.g. mercerising with oxygen, ozone, ozonides, oxides, hydroxides or percompounds; Salts derived from anions with an amphoteric element-oxygen bond
    • D06M11/36Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with inorganic substances or complexes thereof; Such treatment combined with mechanical treatment, e.g. mercerising with oxygen, ozone, ozonides, oxides, hydroxides or percompounds; Salts derived from anions with an amphoteric element-oxygen bond with oxides, hydroxides or mixed oxides; with salts derived from anions with an amphoteric element-oxygen bond
    • D06M11/45Oxides or hydroxides of elements of Groups 3 or 13 of the Periodic Table; Aluminates
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M11/00Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with inorganic substances or complexes thereof; Such treatment combined with mechanical treatment, e.g. mercerising
    • D06M11/32Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with inorganic substances or complexes thereof; Such treatment combined with mechanical treatment, e.g. mercerising with oxygen, ozone, ozonides, oxides, hydroxides or percompounds; Salts derived from anions with an amphoteric element-oxygen bond
    • D06M11/36Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with inorganic substances or complexes thereof; Such treatment combined with mechanical treatment, e.g. mercerising with oxygen, ozone, ozonides, oxides, hydroxides or percompounds; Salts derived from anions with an amphoteric element-oxygen bond with oxides, hydroxides or mixed oxides; with salts derived from anions with an amphoteric element-oxygen bond
    • D06M11/46Oxides or hydroxides of elements of Groups 4 or 14 of the Periodic Table; Titanates; Zirconates; Stannates; Plumbates
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M11/00Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with inorganic substances or complexes thereof; Such treatment combined with mechanical treatment, e.g. mercerising
    • D06M11/77Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with inorganic substances or complexes thereof; Such treatment combined with mechanical treatment, e.g. mercerising with silicon or compounds thereof
    • D06M11/79Treating fibres, threads, yarns, fabrics or fibrous goods made from such materials, with inorganic substances or complexes thereof; Such treatment combined with mechanical treatment, e.g. mercerising with silicon or compounds thereof with silicon dioxide, silicic acids or their salts
    • DTEXTILES; PAPER
    • D06TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06MTREATMENT, NOT PROVIDED FOR ELSEWHERE IN CLASS D06, OF FIBRES, THREADS, YARNS, FABRICS, FEATHERS OR FIBROUS GOODS MADE FROM SUCH MATERIALS
    • D06M15/00Treating fibres, threads, yarns, fabrics, or fibrous goods made from such materials, with macromolecular compounds; Such treatment combined with mechanical treatment
    • D06M15/19Treating fibres, threads, yarns, fabrics, or fibrous goods made from such materials, with macromolecular compounds; Such treatment combined with mechanical treatment with synthetic macromolecular compounds
    • D06M15/37Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • D06M15/643Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds containing silicon in the main chain

Abstract

The subject matter described herein is directed to articles, compositions, systems, and methods of using and preparing bioceramic compositions and to the bioceramic compositions. A bioceramic composition of the disclosure radiates infrared energy or rays and can be used in the treatment of various conditions. A bioceramic composition disclosed herein comprises tourmaline, kaolinite, aluminium oxide, silicon dioxide, and titanium oxide. Methods of plant cultivation by applying a composition comprising the bioceramic are claimed.

Description

BIOCERAMIC COMPOSITIONS AND BIOMODULATORY USES F CROSS REFERENCE This application claims the benefit of U.S. Provisional Application No. 62/115,567, filed on February 12, 2015; U.S. Provisional Application No. 62/064,939, filed on r, 16, 2014, U.S. ional Application No. 62/062,686; filed on r 10, 2014, U.S.
Provisional Application No. 62/018,085, filed on June 27, 2014; and U.S. Provisional Application No. 61/988,837, filed on May 5, 2014; the contents of each of which of which are incorporated by reference herein in their entireties.
BACKGROUND OF THE INVENTION Infrared wavelength ranges from 0.7 to 1000 microns and is just beyond visible light on the electromagnetic spectrum. Infrared has strong physical properties and great thermal activity.
The natural resonant frequency range of water and living organisms, including man, falls within the infrared range. For example, the wavelength range of 6-18 micrometers is beneficial to the human body by virtue of its activating and energizing effect on the body.
Indeed, human skin radiates 9.36 micrometer infrared wave which is very close to the resonant frequency of a water molecule -- and rightly so since our bodies are about 70% water. Infrared waves are considered a safe and beneficial energy source for humans. The instant inventors have identified cial properties of the inventive bioceramic itions and applications as described herein.
SUMMARY OF THE INVENTION [0003a] In a first aspect there is provided a method for increasing the growth of a plant, said method comprising applying a ition comprising a bioceramic to the plant, the amic comprising: a) about 5 wt % to about 15 wt % tourmaline, b) about 40 wt % to about 60 wt % ite, c) about 15 wt % to about 25 wt % aluminium oxide, d) about 10 wt % to about 20 wt % silicon dioxide, and e) about 1 wt % to about 20 wt % zirconium oxide (ZrO2).
As described herein, bioceramics include ceramics which radiate beneficial infrared waves to living organisms. The subject matter described herein utilizes the beneficial s of the ed radiation. The methods, articles, systems, and compositions of matter bed herein employ a unique formulation of bioceramic materials, which are ultra-fine mineral particles, that when heated by a living organism, such as the human body, emit farinfrared energy. The bioceramic materials described herein are refractory polycrystalline compounds that due to their inertness in aqueous ions are highly biocompatible and safe for human interaction and application. The inventors have invented numerous biomodulatory or physiological applications of these bioceramic formulations, including but not d to the regulation of cell metabolism, the induction of analgesia, muscle relaxation and tion of inflammation and oxidative stress.
[NEXT PAGE IS PAGE 2] ing to the laws of thermodynamics, any two bodies in contact reach thermal equilibrium through a direct microscopic exchange of kinetic energy in the form of electromagnetic radiation ted by the thermal motion of the d 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, more speci?cally far infrared radiation. Because of the speci?c properties of the minerals and oxides contained in the subject matter bed herein, i.e., highly refractory minerals, this emission is intensi?ed in the spectrum of far infrared which has numerous biomodulatory or logical effects. The inventors of the instant application have unexpectedly discovered numerous advantages of using the amic materials bed herein to complement or serve as the basis of a therapeutic approach for living organisms.
The subject matter described herein provides a non-invasive, safe, ient, and effective methodology to deliver the positive effects of far—infrared therapy to a subject. For e, in some embodiments, a patient cam'es, wears and/or uses the bioceramic compositions, for example when applied to an article ofmanufacture such as a shirt, at home and/or in the course of ng out daily activities to help extend the bene?ts of the treatment the patient may receive at a clinic or to improve a patient’s condition during or after physical exercise.
A feature of the subject matter described herein, including the es, compositions of matter, methods, devices, and systems, is a composition that comprises a bioceramic, provided that when heated or exposed to heat, such as the warmth of the human body, the bioceramic provides a biomodulatory physiological effect when the article is applied to a subject. In some ments, the article is an apparel of clothing such as a shirt.
Another feature of the subject matter described herein is a bioceramic composition of matter. For example, in one embodiment, the composition comprises (a) about 20 wt % to about 80 wt % kaolinite (AlgSi205(OH)4); (b) about 1 wt % to about 30 wt % tourmaline; (c) about 1 wt % to about 40 wt % aluminum oxide (A1203); (d) about 1 wt % to about 40 wt % silicon dioxide (SiOz); and (e) about 1 wt % to about 20 wt % zirconium oxide (ZrOg); provided that the amounts are by total weight of the bioceramic composition. In another embodiment, the ition comprises: (a) about 40 wt % to about 60 wt % kaolinite (A128i205(OH)4); (b) about wt % to about 15 wt % tourmaline; (0) about 15 wt % to about 25 wt % aluminum oxide (A1203); (d) about 10 wt % to about 20 wt % n e (SiOz); and (e) about 1 wt % to about 20 wt % zirconium oxide (ZrOz); provided that the amounts are by total weight of the bioceramic composition. In yet another embodiment, provided is a bioceramic composition sing: (a) about 50 wt % kaolinite (AlgSi205(OH)4); (b) about 10 wt % tourmaline; (c) _ 2 _ about 18 wt % aluminum oxide (A1203); (d) about 14 wt % silicon dioxide (SiOz); and (e) about 8 wt % zirconium oxide (ZrOg); provided that the amounts are by total weight of the bioceramic composition. In n of these embodiments, the compositions of matter comprise line and the tourmaline comprises 3Al6Si6O18(B03)3(OH) 30H.
An additional feature of the subject matter described herein is the provision of a biomodulatory or physiological effect that comprises: a modulation of pain, an increase in muscle endurance, a modulation of the cardiorespiratory , a modulation of cellular metabolism, analgesia, an anti-oxidative effect, an anti—?bromyalgia effect, a decrease in ation, a decrease in oxidative , a modulation of cytokine levels, a modulation of blood circulation, a ion in intolerance to a cold environment, a reduction in a symptom of arthritis or vascular disease, an increase in cutaneous per?asion, a decrease in heart rate, a decrease in blood pressure, an esthetic effect such as a reduction of body measurements), reduction of , or a reduction in cellulite of the subject.
Yet another e of the subject matter described herein is a vasive method of providing a biomodulatory or physiological effect in or to a subject comprising contacting an article comprising a bioceramic to the skin of the subject, provided that when heated or exposed to heat, the bioceramic composition provides far infrared l radiation and a biomodulatory or physiological effect to the subject in a non-invasive manner.
Another feature of the subject matter described herein is a method for preparing an e comprising the steps of: (a) preparing a bioceramic solution; and (b) applying the solution to the article; provided that the solution, when applied to the article, comprises about 20 wt % to about 80 wt % kaolinite (Alzsi205(OH)4); about 1 wt % to about 30 wt % tourmaline; about 1 wt % to about 40 wt % aluminum oxide (A1203); about 1 wt % to about 40 wt % silicon e (SiOz); and from about 1 wt % to about 20 wt % zirconium oxide (ZrOz) ?arther provided that the amounts are by total weight of the bioceramic composition.
An additional e of the subject matter described herein is a method for preparing an article comprising the steps of: (a) ing a bioceramic solution; and (b) applying the solution on the article; provided that when heated or exposed to heat, the bioceramic provides a biomodulatory or physiological effect when the article is applied to a subject.
BRIEF DESCRIPTION OF THE DRAWINGS The novel and inventive features of the invention are set forth with particularity in the appended claims. A better understanding of the es and advantages of the present invention will be obtained by nce to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings which in this provisional patent application are provided in the Examples section below.
FIGURE 1 illustrates a non-limiting example of a shirt comprising a bioceramic of the instant disclosure FIGURE 2 illustrates a miting example of a shirt and a pad comprising a bioceramic of the instant sure FIGURE 3 is a graph illustrating a miting example of effects of bioceramics of the instant disclosure on ?exibility.
FIGURE 4 is a graph illustrating a non-limiting example of s of bioceramics of the instant disclosure on respiratory capacity.
FIGURE 5 is a graph illustrating a non-limiting example of effects of bioceramics of the instant disclosure on peak expiratory ?ow (PEF).
FIGURE 6 illustrates a non—limiting example of effects of bioceramics of the instant disclosure on muscle endurance.
FIGURE 7 illustrates a non-limiting example of effects of bioceramics of the instant disclosure on cardiorespiratory ?tness.
FIGURE 8 rates a non-limiting example of effects of bioceramic paint on CFA induced ical hypersensitivity.
FIGURE 9 illustrates a non-limiting e of a amic paint of the instant disclosure.
FIGURE 10 illustrates a non-limiting example of apad comprising a bioceramic of the instant sure.
FIGURE 11 illustrates a non-limiting example of a et comprising a bioceramic of the instant disclosure.
FIGURE 12 is a graph rating a miting example of a self-reported reduction of greater than 7.5% overall pain levels in human subjects treated with an apparel of the instant disclosure.
FIGURE 13 is a graph illustrating a non-limiting example of a self-reported improvement of greater than 46% overall health levels of human subjects treated with an apparel of the instant disclosure.
FIGURE 14 is a graph illustrating a non—limiting example of a self-reported reduction of greater than 25 % l fatigue levels in human subjects treated with an apparel of the instant disclosure. _ 4 _ FIGURE 15 is a graph illustrating a non-limiting example of a self-reported ement of greater than 8.5 % overall y of sleep in human subjects with an apparel of the instant disclosure.
FIGURE 16 is a graph illustrating a non—limiting example of a self-reported improvement of greater than 7% overall performance level in human subjects with an apparel of the instant disclosure.
FIGURE 17 shows a non-limiting example of the absolute infrared emission of plain fabric (not comprising a bioceramic).
FIGURE 18 shows a non-limiting example of the absolute infrared emission of a fabric comprising 30 % amics of the instant sure.
FIGURE 19 shows a miting example of the absolute infrared emission of a fabric comprising 50 % bioceramics of the instant sure.
FIGURE 20 are non-limiting examples of graphs illustrating that re to a pad with a higher amic concentrations and longer periods of exposure (both embodiments of the instant disclosure) induced longer lasting results.
FIGURE 21 are non-limiting graphs illustrating the effect of adding bioceramic of the instant disclosure to a water treatment in a hydroponic system.
FIGURE 22 is a miting example of a graph rating the lower ical conductivity of water treated with bioceramics of the instant disclosure presented from day 16 to in comparison to control group (water only).
FIGURE 23 are non-limiting examples ographs showing the effect of amics of the instant disclosure in the grth of organic produce.
FIGURE 24 is a graph illustrating a non—limiting example of the analgesic effect of a far- infrared emitting bioceramic (cFIR) of the instant disclosure versus a ent formulation in the CFA mouse model of induced mechanical hypersensitivity.
FIGURE 25 illustrates a non-limiting example of the infrared transmittance of distinct bioceramic compositions of the instant disclosure. FIGURE 25 A illustrates the infrared transmittance of a bioceramic compositions described herein comprising 18 % aluminium oxide, 14 % silicon dioxide, 50 % kaolinite, 8% zirconium oxide, and 10% tourmaline. FIGURE 25 B illustrates the infrared transmittance of a bioceramic compositions described herein comprising % aluminum, 3% titanium, 11% magnesium oxide, 6% diiron trioxide, and 60% silica.
FIGURE 26 is a graph illustrating the effect of far—infrared emitting bioceramic l on the heart rate and performance based functional exercise capacity of human subjects af?icted with fibromyalgia that followed a hydrotherapy treatment regimen. _ 5 _ FIGURE 27 trates that hydrotherapy in combination with the use of control apparel did not affect the balance of the subjects, whereas the use of far-infrared emitting bioceramic statistically reduced latero-lateral oscillations.
FIGURE 28 is a graph illustrating the overall perceived pain level effects of human subjects af?icted with ?bromyalgia that are treated with a far—infrared emitting bioceramic l or a sham l.
FIGURE 29A is a graph illustrating the results of a algia impact questionnaire (FIQ) (PANEL A), McGill pain questionnaire (PANEL B), and McGill descriptors index (PANEL C).
FIGURE 30 is an organization ?owchart of a study of the disclosure.
FIGURE 31 is a graph illustrating the effect of far-infrared emitting bioceramic apparel on on postural control.
FIGURE 32 is a graph illustrating the effect of frared emitting bioceramic apparel on the ?exibility and grip strength of pilates practitioners.
FIGURE 33 is a graph illustrating the effect of far-infrared emitting bioceramic apparel on the stabilometry (latero-lateral) of pilates practitioners.
FIGURE 34 is a graph illustrating the effect of far-infrared emitting bioceramic apparel on the stabilometry (antero-posterior) of pilates practitioners.
FIGURE 35 illustrates the effect of far-infrared emitting bioceramic apparel on the heart rate variability (HRV) of pilates practitioners.
FIGURE 36 illustrate the results of far-infrared emitting bioceramic apparel on day dysfunction (Panel A), quality of sleep (Panel B), and sleep ency (Panel C).
FIGURE 37 illustrate the s of frared emitting bioceramic apparel on sleep duration (Panel A), sleep disturbance (Panel B), and PQSI (Panel C).
FIGURE 38 illustrate the results London Chest Activity of Daily Living Questionnaire (LCADL) in subjects af?icted with c Obstructive Pulmonary Disease (COPD).
FIGURE 39 illustrate the results of the performance-based ?anctional exercise capacity test in subjects af?icted with Chronic Obstructive Pulmonary e (COPD).
FIGURE 40 illustrate the results of a heart rate ce test (HRV) (frequency domain) in subjects af?icted with Chronic Obstructive Pulmonary Disease (COPD) before and a?er treatment with a bioceramic.
FIGURE 41 illustrate the results of a heart rate variance test (HRV) (time domain) in subjects af?icted with c Obstructive ary Disease (COPD) before and after treatment with a bioceramic. _ 6 _ FIGURE 42 illustrate the s on the initial V02 consumption of young baseball players exercising with bioceramic t-shirts or sham t-shirts..
FIGURE 43 illustrate the results on the l VOzMax of young baseball players sing with bioceramic ts or sham t-shirts..
FIGURE 44 illustrate the results of the aerobic threshold of young baseball players exercising with bioceramic t-shirts or sham t—shirts.
FIGURE 45 illustrate the results of the anaerobic threshold of young baseball players exercising with amic ts or sham t-shirts.
FIGURE 46 illustrate the heart rate recovery of young baseball players exercising with bioceramic t-shirts or sham t-shirts.
FIGURE 47A illustrate the results of far—infrared emitting bioceramic apparel on sleep on (Panel A), sleep disturbance (Panel B), and day disfunction (Panel C) of young baseball s. FIGURE 47B illustrate the results of far—infrared emitting bioceramic apparel on day dysfunction due to sleepiness (Panel A), sleep y (Panel B), and PQSI (Panel C) of young baseball players.
DETAILED DESCRIPTION OF THE INVENTION As used in this document, the singular forms 4‘ 3) (L a an," and "the" include plural references unless the context clearly dictates otherwise. Unless de?ned otherwise, all cal and scienti?c terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. As used in this document, the term "comprising" means "including, but not limited to." t being limited by theory the instant inventors have discovered that the biological effects of bioceramics are based on the fact that the infrared frequency range is the natural resonant frequency range of water and living organisms. Because a erable part of living organisms include water, the resonant frequency of water molecules radiated from the bioceramics described herein can activate the water and affect living organisms, including humans, and including the treatment of disease and biological complications and pathways.
The bioceramics of the disclosure radiate far infrared energy towards the body or away from the body of a subject. When a bioceramic radiates energy towards the body of a t, the bioceramic provides concentrated radiant energy to cells by re?ecting the far infrared energy or rays of the body heat into the subject’s joints, muscles, and tissues. The far ed energy penetrates the cells and provides biomodulatory or physiological effects, such as anti- in?ammatory, analgesic, and other biomodulatory or physiological effects. When a bioceramic radiates energy away from the body of a subject, the bioceramic prevents far infrared energy from penetrating the skin of a subject, thereby providing a cooling effect.
Bioceramic Compositions An aspect of the articles, itions of matter, 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, provided is a bioceramic composition that when heated or exposed to heat provides a biomodulatory or physiological effect when the article is applied to a subject. In one ment, the bioceramic a about 20 wt % to about 80 wt % kaolinite (AlgSi205(OH)4); b. about 1 wt % to about 30 wt % tourmaline; c. about 1 wt % to about 40 wt % aluminum oxide (A1203); (1. about 1 wt % to about 40 wt % silicon dioxide (SiOz); and e. about 1 wt % to about 20 wt % zirconium oxide (ZrOz); ed that the amounts are by total weight of the bioceramic composition.
In further or additional embodiments, provided is a bioceramic composition of matter that when heated or exposed to heat provides a biomodulatory or physiological effect when the e is applied to a subject, comprising: a. about 40 wt % to about 60 wt % ite (A128i205(OH)4); b. about 5 wt % to about 15 wt % tourmaline; c. about 15 wt % to about 25 wt % aluminum oxide (A1203); d. about 10 wt % to about 20 wt % silicon dioxide (SiOz); and e. about 1 wt % to about 20 wt % zirconium oxide ; provided that the amounts are by total weight of the amic composition. In some ments, the bioceramic composition comprises kaolinite in a range from about 45 wt % to about 55 wt %. In further or onal embodiments, provided is a bioceramic composition that comprises kaolinite in the range from about 47 wt % to about 53 wt %. In further or additional embodiments, provided is a bioceramic composition that contains kaolinite in a range from about 48 wt % to about 52 wt %.
In some embodiments, provided is a bioceramic ition that comprises a. about 50 wt % kaolinite (AIZSi205(OH)4); b. about 10 wt % tourmaline; c. about 18 wt % aluminum oxide (A1203); _ 8 _ (1. about 14 wt % silicon e (SiOz); and e. about 8 wt % ium oxide (ZrOz).
Another feature of the subject matter described herein are bioceramic compositions that include tourmaline. As used herein, the term "tourmaline" retains its meaning known in the mineral and gemstone arts. For example, tourmaline, is a group of isomorphous minerals with an identical crystal e. Each member of the tourmaline group has its own chemical formula, due to small differences in their elemental distribution. For example, in some embodiments, the tourmaline has the following generic formula X1Y3Al6(B03)3Si6018(OH)4, where: X = Na and/or Ca and Y = Mg, Li, Al, and/or Fe2+’ which is represented with the following formula, (Na,Ca)(Mg,Li,Al,Fe2+)3Al6(B03)3Si6018(OH)4.
In some embodiments, the Al may be replaced by other elements. For e, in UVite, the Al is partially replaced by Mg which expands the a to: CNa,Ca)(Mg,Li,Al,Fe2+)3 (Al,Mg,Cr)6(B03)3Si6018(OH)4, In some embodiments, the tourmaline is rite which contains three 0 atoms and one F atom in place of the OH radical. A Buergerite molecule also contains an Fe atom that is in a 3+ oxidation state which is depicted as: (Na,Ca)(Mg,Li,Al,Fe2+,Fe3+)3(Al,Mg,Cr)6(B03)3Si6O18(OH,O,F)4. In other embodiments, the line is one or more of the following: o Schorl: NaFe2+3Al6(B03)3Si6018(OH)4; o Dravite: 16(B03)3Si6018(OH)4; o Elbaite: Na(Li,Al)3Al6(B03)3Si6018(OH)4; o Liddicoatite: Ca(Li,Al)3Al6(B03)3Si6O18(OH)4; . Uvite: Ca(Mg,Fe2+)3A15Mg(B03)3Si6O18(OH)4; o Buergerite: NaFe3+3Al6(BO3)3Si6O1803F.
In one embodiment, the bioceramic composition tourmaline that comprises NaFe2+3A168i6018(BO3)3(OH) 3on.
Another aspect of the articles, itions of matter, methods, devices, and systems described herein is a bioceramic composition of micrometer particle size. For e, in some embodiments, provided is a bioceramic composition containing a largest dimension of any particle in the bioceramic of from about 0.1 micrometer (um) to about 250 micrometers. In further or additional embodiments, ed is a bioceramic composition, provided that the largest dimension of any particle in the bioceramic is from about 0.5 micrometers to about 25 micrometers. In some cases, a bioceramic le can have a diameter, or cross-sectional area, of about 0.1 um to about 1 um, of about 0.1um to about 10 um, of about 0.1um to about 20 um, of about 0.1um to about 30 um, of about 0.1um to about 40 um, of about 0.1um to about 50 um, of about 0.1um to about 60 um, of about 0.1um to about 70 um, of about 0.1um to about 80 um, of about 0.1um to about 90 um, of about 0.1um to about 100 um, or other desired size. In some cases, an inlet can have a cross-sectional diameter of about 10 um to about 100 um, of about 10 um to about 200 um, of about 10 um to about 300 um, of about 10 um to about 400 um, of about um to about 500 um, or other desired Size.
In r or additional embodiments, provided is a bioceramic composition of matter that when heated or exposed to heat provides a biomodulatory or physiological effect when the article is applied to a subject, wherein the bioceramic composition comprises tourmaline, kaolinite and at least one oxide. In some cases a bioceramic of the disclosure comprises line, kaolinite, aluminum oxide and silicon dioxide. In some cases a bioceramic of the disclosure comprises tourmaline, kaolinite, aluminum oxide, silicon dioxide and one other oxide. In some cases, the other oxide is zirconium oxide. In some cases the other oxide is titanium dioxide (Ti02). In some cases the other oxide is magnesium oxide (MgO).
Kaolinite, is a layered silicate mineral sing . In some cases, various oxides are comprised within the kaolinite. In some cases, a bioceramic composition comprises additional oxides that are not part of the kaolinite. In some embodiments, a bioceramic composition comprises one oxide, two oxides, three oxides, four oxides, ?ve oxides, six oxides, seven oxides, eight oxides, nine oxides, ten oxides, eleven oxides, twelve , or more oxides.
In some cases, the additional oxides are highly refractory oxides.
In some ments, an oxide of a bioceramic composition of matter of the sure has various oxidation states. An oxide of the disclosure has an oxidation number of +1 , +2, +3, +4, +5, +6, +7, or +8. In some cases a bioceramic composition of the sure will have more than one oxide wherein at least one oxide has a different oxidation number as compared to the other oxide. For example, in some cases a bioceramic composition of the disclosure comprises an um oxide (A1203) with a +2 or a +3 oxidation state, a silicon dioxide (Si02) with a +4 oxidation state, and a zirconium oxide (Zr02) with a +4 oxidation state.
Non-limiting es of oxides with +1 oxidation state include: copper(I) oxide (Cu20), dicarbon monoxide (C20), dichlorine monoxide (C120), lithium oxide (Li20), potassium oxide (K20), rubidium oxide (Rb20), silver oxide (Ag20), thallium(I) oxide (T120), sodium oxide , or water (Hydrogen oxide) (H20).
Non-limiting examples of oxides with +2 ion state include: ium(II) oxide (A10), barium oxide (Ba0), beryllium oxide (Be0), cadmium oxide (Cd0), calcium oxide _ 10 _ (Ca0), carbon monoxide (CO), chromium(II) oxide (Cr0), cobalt(II) oxide (C00), copper(II) oxide (Cu0), iron(II) oxide (Fe0), lead(II) oxide (Pb0), magnesium oxide (Mg0), mercury(II) oxide (Hg0), nickel(II) oxide (Ni0), nitric oxide (NO), palladium(II) oxide (Pd0), ium oxide (SrO), sulfur monoxide (SO), disulfur dioxide (S202), tin(II) oxide (SnO), titanium(II) oxide (Ti0), vanadium(II) oxide (V0), or zinc oxide (ZnO).
Non-limiting examples of oxides with +3 oxidation states include: ium oxide (A1203), antimony trioxide (Sb203), arsenic trioxide (AS203), bismuth(III) oxide ), boron trioxide (B203), chromium(III) oxide (Cr203), dinitrogen trioxide (N203), erbium(III) oxide (Er203), gadolinium(III) oxide (Gd203), gallium(III) oxide ), holmium(III) oxide (H0203) oxide (In203), iron(III) oxide (Fe203), lanthanum oxide (La203), lutetium(III) oxide , indium(III) (Lu203), nickel(III) oxide (Ni203), phosphorus trioxide , promethium(III) oxide (Pm203), rhodium(III) oxide (Rh203), samarium(III) oxide (Sm203), scandium oxide (SC203), terbium(III) oxide (Tb203), thallium(III) oxide (T1203), thulium(III) oxide (Tm203), titanium(III) oxide (Ti203), tungsten(III) oxide , vanadium(III) oxide (V203), ytterbium(III) oxide (Yb203), yttrium(III) oxide (Y203). miting examples of oxides with +4 oxidation states include: carbon dioxide (CO2), carbon trioxide (C03), (IV) oxide (Ce02), ne dioxide (C102), um(IV) oxide (Cr02), ogen tetroxide (N204), germanium dioxide (Ge02), hafnium(IV) oxide (Hf02), lead dioxide (Pb02), manganese dioxide (Mn02), en dioxide (N02), plutonium(IV) oxide (Pu02), rhodium(IV) oxide (Rh02), ruthenium(IV) oxide (Ru02), selenium dioxide (Se02), silicon dioxide (Si02), sulfur dioxide ($02), tellurium dioxide (Te02), thorium dioxide (Th02), tin dioxide (Sn02), titanium dioxide (Ti02), tungsten(IV) oxide (W02), uranium dioxide (U02), um(IV) oxide (V02), or zirconium dioxide (Zr02).
Non-limiting examples of oxides with +5 oxidation states include: antimony pentoxide (Sb205), arsenic pentoxide (AS205), dinitrogen pentoxide (N205), m pentoxide (Nb205), phosphorus pentoxide (P205), um pentoxide (Ta205), or vanadium(V) oxide (V205). Non- limiting examples of oxides with +6 oxidation states include: chromium trioxide , molybdenum trioxide , rhenium trioxide (Re03), um de (Se03), sulfur trioxide (SO3), tellurium trioxide (Te03), tungsten de (W03), uranium trioxide (U03), or xenon trioxide (Xe03).
Non-limiting examples of oxides with +7 oxidation states include: dichlorine heptoxide (C1207), manganese heptoxide (Mn207), rhenium(VII) oxide (Re207), or technetium(VII) oxide (TC207). miting examples of oxides with +8 oxidation states include: osmium tetroxide (0504), ruthenium tetroxide (Ru04), xenon tetroxide , iridium tetroxide (Ir04), or _ 11 _ hassium tetroxide (HsO4). Non-limiting examples of oxides with various states of oxidation include antimony tetroxide (Sb204), cobalt(II,III) oxide (C0304), iron(II,III) oxide (Fe304), lead(II,IV) oxide (Pb304), ese(II,III) oxide (Mn304), or silver(I,III) oxide (AgO).
In further or additional embodiments a bioceramic composition of matter of the disclosure further comprises a metal. A metal can be in elemental form, such as a metal atom, or a metal ion. Non-limiting examples of metals include transition metals, main group metals, and metals of 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 of the ic Table. Non-limiting examples of metal include um, titanium, vanadium, chromium, manganese, iron, cobalt, nickel, copper, zinc, m, zirconium, niobium, molybdenum, tium, ium, rhodium, palladium, silver, cadmium, lanthanum, hafnium, tantalum, tungsten, rhenium, osmium, iridium, platinum, gold, mercury, tin, lead, and bismuth.
The tion of minerals and oxides in a bioceramic composition can optionally be altered ing on a number of variables, including, for example, the amount of thermal radiation, more speci?cally far infrared radiation, to be emitted, the disease or ion to be treated, the mode of administration, the requirements of the individual subject, the severity of the disease or condition being treated, or the judgment of a practitioner.
Physical Properties Tourmaline and kaolinate have distinct ometric, mineralogical, chemical, and physical properties depending on, for example, whether the minerals are extracted from a particular geographic region or whether the ls are chemically sized. For instance, in many parts of the world a kaolinite has a pink—orange-red tion that is associated with an amount of an impurity(ies). Often, the impurity(ies) comprises iron oxide. In some embodiments, a kaolinite of the disclosure is of a high purity level, and it is characterized by a ?ne white color.
In some embodiments, a purity of the tourmaline or kaolinate is associated with an amount of infrared energy that is radiated from a amic composition. In some cases the kaolinite or tourmaline of a bioceramic composition of the disclosure is greater than 99 % pure, greater than 98 % pure, r than 97 % pure, greater than 96 % pure, greater than 95 % pure, greater than 94 % pure, greater than 93 % pure, greater than 92 % pure, greater than 91 % pure, greater than 90 % pure, greater than 89 % pure, greater than 88 % pure, greater than 87 % pure, greater than 86 % pure, greater than 85 % pure, greater than 80 % pure, greater than 75 % pure, r than 70 % pure, greater than 65 % pure, greater than 60 % pure, or greater than 55 % _ 12 _ pure.
In some ments, a granularity of a kaolinite or tourmaline is ated with an amount of infrared energy that is radiated from a bioceramic composition. For instance, a bioceramic composition comprising coarser—size mineral re?ects a different amount of infrared energy as compared to a bioceramic composition comprising ?ner-size ls. In some embodiments, the granularity of a bioceramic composition ranges from about 100 nanometers to about 0.1 micrometers, from about 100 nanometers to about 1 micrometer, from about 100 nanometers to about 10 eters, from about 100 nanometers to about 25 micrometers, from about 100 nanometers to about 50 micrometers, from about 100 nanometers to about 75 micrometers, from about 100 nanometers to about 100 micrometers, from about 100 nanometers to about 125 micrometers, from about 100 nanometers to about 150 eters, from about 100 ters to about 175 eters, from about 100 nanometers to about 200 micrometers, from about 100 nanometers to about 225 micrometers, or from about 100 nanometers to about 250 micrometers.
In some embodiments, the granularity of a bioceramic composition ranges from about 0.5 micrometers to about 1 micrometer, from about 0.5 micrometers to about 10 micrometers, from about 0.5 micrometers to about 25 micrometers, from about 0.5 micrometers to about 50 micrometers, from about 0.5 micrometers to about 75 micrometers, from about 0.5 micrometers to about 100 micrometers, from about 0.5 micrometers to about 125 eters, from about 0.5 micrometers to about 150 micrometers, from about 0.5 micrometers to about 175 micrometers, from about 0.5 micrometers to about 200 micrometers, from about 0.5 micrometers to about 225 micrometers, or from about 0.5 micrometers to about 250 micrometers.
Far-Infrared Emittancea Transmission, and Re?ection Yet another aspect of the articles, compositions of matter, methods, s, and systems described herein is a bioceramic composition that emits, transmits, and/or re?ects an infrared ngth when heated or exposed to heat. In some embodiments, provided is a bioceramic. In some embodiments, provided is a amic that absorbs, stores, and/or re?ects thermal energy, such as far infrared energy or rays. In some embodiments, provided is a bioceramic that emits, transmits, or s an infrared wavelength that is far ed and that comprises a wavelength from about 1 micrometer to about 1 eter. In ?thher or additional embodiments, provided is a bioceramic composition that emits, transmits, or re?ects an infrared wavelength that is from about 3 micrometers to about 15 micrometers. In ?irther or additional embodiments, described herein is a bioceramic composition that provides a re?ectance of the bioceramic at a room _ 13 _ temperature of 25°C is at least 80% in an infrared range between about 7 micrometers and about 12 micrometers.
The material emissivity of a bioceramic material can be measured with, for example, a calorimeter or a Flir thermographic camera. A calorimeter can be used to measure the amount of thermal energy that can be received, store, and/or release by an apparel comprising a bioceramic.
A Flir thermographic camera can create a thermal image of various types of apparel comprising a bioceramic of the disclosure. A Flir thermographic camera can detect up to thousands of measurement points in each l image and e emissivity data for each image.
A bioceramic composition of the disclosure is ated to have desired refractory properties. In some embodiments a bioceramic of the disclosure re?ects about 99 % of the ed energy or rays received, about 98 % of the infrared energy or rays received, about 97 % of the infrared energy or rays received, about 96 % of the infrared energy or rays received, about 95 % of the infrared energy or rays ed, about 94 % of the infrared energy or rays ed, about 93 % of the infrared energy or rays received, about 92 % of the infrared energy or rays received, about 91 % of the infrared energy or rays received, about 90 % of the infrared energy or rays received, about 89 % of the infrared energy or rays received, about 88 % of the infrared energy or rays received, about 87 % ofthe ed energy or rays received, about 86 % of the infrared energy or rays received, about 85 % of the ed energy or rays received, about 84 % of the infrared energy or rays received, about 83 % of the infrared energy or rays received, about 82 % of the infrared energy or rays received, about 81 % of the infrared energy or rays received, about 80 % of the infrared energy or rays received, about 79 % of the infrared energy or rays received, about 78 % of the infrared energy or rays received, about 77 % of the infrared energy or rays ed, about 76 % of the infrared energy or rays received, about 75 % of the infrared energy or rays received, about 74 % ofthe infrared energy or rays received, about 73 % of the infrared energy or rays received, about 72 % of the infrared energy or rays received, about 71 % of the infrared energy or rays ed, about 70 % of the infrared energy or rays received, about 65 % of the infrared energy or rays received, about 60 % of the infrared energy or rays received, about 55 % of the infrared energy or rays received, about 50 % of the infrared energy or rays received, about 45 % of the infrared energy or rays received, about 40 % of the infrared energy or rays received, about 35 % of the ed energy or rays received, about 30 % of the infrared energy or rays received, about 25% of the infrared energy or rays received, about 20 % of the infrared energy or rays received, about 15 % of the ed energy or rays received, about 10 % of the infrared energy or rays ed, or about 5 % of the infrared energy or rays received.
In some cases a bioceramic of the disclosure re?ects greater than 99 % of the infrared energy or rays received, greater than 98 % of the ed energy or rays received, greater than 97 % of the infrared energy or rays received, greater than 96 % of the infrared energy or rays received, greater than 95 % of the infrared energy or rays received, r than 94 % of the infrared energy or rays received, greater than 93 % of the infrared energy or rays ed, greater than 92 % of the infrared energy or rays received, greater than 91 % of the infrared energy or rays received, greater than 90 % 0f the infrared energy or rays received, greater than 89 % of the infrared energy or rays received, greater than 88 % 0f the ed energy or rays received, greater than 87 % of the infrared energy or rays received, greater than 86 % of the infrared energy or rays received, greater than 85 % of the infrared energy or rays received, greater than 84 % of the infrared energy or rays ed, greater than 83 % of the infrared energy or rays received, greater than 82 % of the infrared energy or rays received, r than 81 % of the infrared energy or rays received, greater than 80 % of the infrared energy or rays received, greater than 79 % of the infrared energy or rays received, greater than 78 % of the infrared energy or rays received, greater than 77 % of the infrared energy or rays received, greater than 76 % of the infrared energy or rays received, r than 75 % of the infrared energy or rays received, greater than 74 % of the infrared energy or rays received, greater than 73 % of the infrared energy or rays received, greater than 72 % of the infrared energy or rays received, r than 71 % of the infrared energy or rays received, greater than 70 % of the infrared energy or rays received, greater than 65 % of the infrared energy or rays ed, greater than 60 % of the infrared energy or rays received, greater than 55 % of the infrared energy or rays ed, greater than 50 % 0f the infrared energy or rays received, greater than 45 % of the infrared energy or rays received, greater than 40 % of the infrared energy or rays received, greater than 35 % of the infrared energy or rays received, greater than 30 % of the infrared energy or rays received, r than 25% of the infrared energy or rays received, greater than 20 % of the infrared energy or rays received, greater than 15 % of the infrared energy or rays received, greater than 10 % 0f the infrared energy or rays received, or greater than % of the infrared energy or rays received.
In some cases a bioceramic of the disclosure re?ects fewer than 99 % of the infrared energy or rays received, fewer than 98 % of the ed energy or rays received, fewer than 97 % of the infrared energy or rays received, fewer than 96 % of the infrared energy or rays ed, fewer than 95 % of the infrared energy or rays received, fewer than 94 % of the infrared energy or rays received, fewer than 93 % of the infrared energy or rays received, fewer than 92 % of the infrared energy or rays ed, fewer than 91 % of the infrared energy or rays received, fewer _ 15 _ than 90 % of the infrared energy or rays received, fewer than 89 % of the infrared energy or rays received, fewer than 88 % of the infrared energy or rays received, fewer than 87 % of the infrared energy or rays received, fewer than 86 % of the infrared energy or rays received, fewer than 85 % of the infrared energy or rays received, fewer than 84 % of the infrared energy or rays received, fewer than 83 % of the infrared energy or rays received, fewer than 82 % of the infrared energy or rays ed, fewer than 81 % of the infrared energy or rays received, fewer than 80 % of the infrared energy or rays received, fewer than 79 % of the infrared energy or rays received, fewer than 78 % of the infrared energy or rays received, fewer than 77 % of the infrared energy or rays received, fewer than 76 % of the infrared energy or rays received, fewer than 75 % of the infrared energy or rays received, fewer than 74 % of the ed energy or rays received, fewer than 73 % of the infrared energy or rays received, fewer than 72 % of the infrared energy or rays received, fewer than 71 % of the infrared energy or rays received, fewer than 70 % of the infrared energy or rays received, fewer than 65 % of the infrared energy or rays received, fewer than 60 % of the infrared energy or rays received, fewer than 55 % of the infrared energy or rays received, fewer than 50 % of the infrared energy or rays received, fewer than 45 % of the infrared energy or rays received, fewer than 40 % of the infrared energy or rays received, fewer than 35 % of the infrared energy or rays received, fewer than 30 % ofthe infrared energy or rays received, fewer than 25% of the infrared energy or rays received, fewer than 20 % of the ed energy or rays received, fewer than 15 % of the infrared energy or rays received, fewer than 10 % of the infrared energy or rays received, or fewer than 5 % of the infrared energy or rays received.
In some embodiments, the bioceramic re?ects far infrared energy towards the body of a t and in some ments the bioceramic re?ects far infrared energy away from the body of the subject. A bioceramic can provide a g effect when it s ed energy away from the body. In some embodiments a bioceramic is nt to or near an insulator. In some embodiments, an article comprising an insulated amic es a cooling effect to a subject, provided that when heated or exposed to heat, the bioceramic re?ects the far infrared rays away from the subject.
In some embodiments, an apparel of the sure comprises an insulator that is in contact with or is adjacent to a bioceramic. The insulator can be used in ments where the apparel comprising the bioceramic is fabricated to re?ect far infrared energy away from the body of a subject. In some embodiments, the insulator is a material of low thermal conductivity and prevents far infrared energy from being re?ected in a direction. Different types of materials can be used to re?ect infrared, non-limiting examples of insulators include rubber, glass, paper, plastic, wood, cloth, foil, or styrofoam. _ 16 _ An apparel of the disclosure can e a therapeutically-effective amount of infrared to a subject. In some cases the apparel is a shirt comprising a bioceramic, and when exposed to heat, the shirt comprising the bioceramic provides at least 1.5 joules/cm2 of far infrared rays to a subject. In some cases the l is athletic apparel, a sporting accessory, or a sports equipment including, but not limited to, orthotic inserts, athletic shoes, diving suits, life preservers, shirts, , wrist bands, arm bands, head bands, gloves, jackets, pants, hats, and backpacks, skis, ski poles, snowboards, skateboards, in-line skates, bicycles, surf boards, water skis, jet skis, diving equipment, ropes, chains, goggles, and/or blankets. In some embodiments, the apparel is a sporting ory, including but not limited to a t. In some embodiments, the apparel is con?gured for use in ic applications, including but not limited to orthotic inserts, shoes, and the like. In some cases the apparel is a patch (e.g. a patch that is fabricated to adhere to skin or not, such as transdermal patches, transdermal hydrogel patches, etc.), adhesive tape, such as kinesio, non-adhesive tape, pads, insoles, bedding, including a sheet, a mattress, a cover, a pillow, and/or a pillow case, a body support, a foam , a lotion, a soap, tape, glassware, furniture, paint, ink, a label, carpet, a mat, a food and/or beverage container, a drink koozie (e. g. bottle or can), headware (e. g. a helmet, a hat, etc.), ar (e. g. a shoe, sneaker, sandal, etc.), an earphone, a surface, a sports surface, an arti?cial grass, and the like. In some cases, the apparel is a shirt, a pant, a short, dresses, a skirt, jacket, a hat, an arment, a sock, a cap, a glove, a scarf, a diaper, a blanket, a comforter, aduvet cover, a mattress cover, a mattress pad, and the like. In another ment, the article is a body support selected from a knee wrap, an elbow support, a compression arm sleeve, a compression leg sleeve, a wrist wrap, and the like.
In some embodiments, the subject matter described herein provides from 1 joule/cm2 to 45 joules/cm2, from 2-10 joules/cmz, or from 4-6 joules/cm2 of far infra-red energy rays or rays to a subject. In certain embodiments, the bioceramic formulation that provides at least 1 joule/cmz, 1.5 joules/cmz, at least 2 joules/cmz, at least 3 joules/cmz, at least 4 joules/cmz, at least joules/cmz, at least 6 joules/c1112, at least 7 joules/cmz, at least 8 joules/c1112, at least 9 joules/ch, at least 10 joules/cmz, at least 11 joules/cm2, at least 12 joules/cm2, at least 13 /cmz, at least 14 joules/cmz, at least 15 /cm2, at least 16 joules/cmz, at least 17 /cmz, at least 18 joules/cmz, at least 19 joules/cmz, at least 20 joules/cmz, at least 21 joules/cmz, at least 22 /cmz, at least 23 joules/cmz, at least 24 joules/cmz, at least 25 joules/cmz, at least 26 joules/cmz, at least 27 joules/cmz, at least 28 joules/cmz, at least 29 joules/cmz, at least 30 joules/cmz, at least 31 joules/cmz, at least 32 joules/cm2, at least 33 joules/cmz, at least 34 /cmz, at least 35 joules/cmz, at least 36 joules/cmz, at least 37 joules/cmz, at least 38 joules/cmz, at least 39 joules/cmz, at least 40 joules/cmz, at least 41 _ 17 _ joules/cmz, at least 42 joules/cmz, at least 43 joules/cmz, at least 44 joules/cmz, or about 45 joules/cm2 of far infrared energy or rays to a subject.
In some cases, an apparel of the sure can provide at most 1.5 joules/cmz, at most 2 joules/cmz, at most 3 joules/cmz, at most 4 joules/cmz, at most 5 joules/cmz, at most 6 joules/cmz, at most 7 joules/cmz, at most 8 joules/cmz, at most 9 joules/cmz, at most 10 joules/cmz, at most 11 joules/cmz, at most 12 joules/cmz, at most 13 joules/cmz, at most 14 joules/cmz, at most 15 joules/cmz, at most 16 joules/cmz, at most 17 /cmz, at most 18 joules/cmz, at most 19 joules/ch, at most 20 /cmz, at most 21 joules/cm2, at most 22 joules/cm2, at most 23 /cmz, at most 24 joules/cmz, at most 25 joules/cmz, at most 26 joules/cmz, at most 27 joules/cmz, at most 28 joules/cmz, at most 29 joules/cmz, at most 30 joules/cmz, at most 31 joules/cmz, at most 32 joules/cmz, at most 33 joules/cmz, at most 34 joules/cmz, at most 35 joules/cmz, at most 36 joules/cmz, at most 37 joules/cmz, at most 38 /cmz, at most 39 joules/cmz, at most 40 joules/cmz, at most 41 joules/cmz, at most 42 joules/cmz, at most 43 joules/cmz, at most 44 joules/cmz, or at most 45 joules/cm2 of far infrared energy or rays to a subject.
In some cases, an apparel of the disclosure provides between 1.5 joules/cm2 and 45 joules/cmz, between 1.5 joules/cm2 and 40 joules/cmz, between 1.5 /cm2 and 35 joules/cmz, n 1.5 joules/cm2 and 30 joules/cmz, between 1.5 joules/cm2 and 25 joules/cmz, between 1.5 joules/cm2 and 20 joules/cmz, between 1.5 joules/cm2 and 15 joules/cmz, between 1.5 joules/cm2 and 10 joules/cmz, between 1.5 joules/cm2 and 5 joules/cmz, between 2 joules/cm2 and 45 joules/cmz, between 2 joules/cm2 and 40 joules/cm2, between 2 joules/cm2 and 35 joules/cmz, between 2 joules/cm2 and 30 joules/cmz, between 2 joules/cm2 and 25 joules/cm2, between 2 joules/cm2 and 20 joules/cmz, between 2 joules/cm2 and 15 joules/cmz, between 2 /cm2 and joules/cmz, between 2 joules/cm2 and 5 joules/cm2 of far ed energy or rays to a subject.
In some cases, the apparatus is a shirt, and the shirt provides at most 45 joules/cm2 of far infrared energy or rays to a subject. ed energy can be absorbed, re?ected, or emitted by les. In many cases, the thermal ion emitted by objects on 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 ed by molecules upon a rotational and/or Vibrational nts. In certain embodiments, the bioceramic materials provided herein es infrared energy elicits vibrational modes in a molecule through a change in the dipole moment. In some embodiments, absorption of heat by a bioceramic of the instant disclosure elicits vibrational modes in at least _ l8 _ one molecule of the bioceramic through changes in the dipole moment. Further, infrared energy from the thermal ion, in certain embodiments, is absorbed and re?ected by molecules in the bioceramic when they change their rotational—vibrational energy. In further or additional embodiments, provided herein is a bioceramic that comprises a formulation of a ceramic material and vibrational technology that provides enhanced bio-modulatory properties when in t with or applied to a subject, including as one example a human subject.
Articles An aspect of the articles, compositions of matter, methods, devices, and systems described herein is an e sing a composition that comprises a bioceramic, provided that when heated or exposed to heat, the bioceramic provides a ulatory or physiological effect when the article is applied to a subject.
In some embodiments, provided are articles that incorporate a bioceramic composition, and articles with bioceramics applied to them. In one embodiment, the bioceramic composition is present as a coating on at least a portion of the surface of the article (for example on the inside or the outside of the article) or is incorporated ly into a substrate prior to or during manufacture of the article itself. In another embodiment, the substrate is a polymeric, cloth, or metallic material.
In some ments, provided are bioceramic compositions that r comprise a substrate, a binder, a solvent, a polymer, or an ink. In some embodiments, provided is a amic ition that further comprises a ate that comprises at least one elastomer. In some embodiments, provided is a bioceramic composition that further comprises a polymer that is selected from the group ting of polyoxybenzylmethylenglycolanhydride, polyvinyl chloride, polystyrene, hylene, polypropylene, polacrylonitrile, polyvinyl butyral, polylactic acid, and combinations thereof. In further or onal embodiments, ed is a bioceramic composition ning an elastomer that is selected from the group consisting of polychloroprene, nylon, a polyvinyl chloride elastomer, a polystyrene elastomer, a polyethylene elastomer, a polypropylene elastomer, a polyvinyl butyral elastomer, silicone, a thermoplastic elastomer, and combinations f.
In some embodiments, provided is an article containing a bioceramic composition that further comprises a substrate that comprises a material selected from the group consisting of wool, silk, cotton, canvas, jute, glass, nylon, polyester, acrylic, elastane, loroprene, expanded polytetra?uoroethylene-containing laminate fabrics, and combinations thereof. In still further or additional embodiments, provided is an article containing a bioceramic composition that ?arther ses a l.
For example, in one embodiment a polymeric article is prepared by mixing a bioceramic composition with the polymeric substrate, or alternatively applying the bioceramic to the substrate, while the substrate is in a liquid or ?uid form. In some embodiments, the amount of bioceramic composition incorporated into the polymeric substrate or that is applied to the substrate can be any suitable amount that s a suf?cient amount of far infrared energy. In one embodiment, the bioceramic composition is added in an amount from about 1 wt% to about 75 wt% by total weight of the article. In another embodiment, the bioceramic composition is added in an amount from about 0.01 wt% to about 25 wt% by total weight of the article. In yet another embodiment, the bioceramic composition is added in an amount from about 3 wt% to about 20 wt% by total weight of the article. In a further embodiment, the bioceramic composition is added in an amount from about 7 wt% to about 13 wt% by total weight of the e. In another embodiment, the ric substrate is in the form of a cloth substrate, such as a shirt, which is sed in greater detail below.
The polymeric substrate es any polymer that is useful for preparing an article. For example, the polymeric substrate includes at least one elastomeric polymer or at least one non-elastomeric polymer. As linked polymers and polymer systems, polymer blends that include continuous and/or dispersed , and the like.
Elastomers include, but are not limited to, lastic polymers, such as, for e, natural s, synthetic rubbers, rubbery, and rubber-like polymeric materials. One example of a synthetic rubber is polychloroprene ene). In one embodiment, the elastomer is selected from loroprene, nylon, a polyvinyl chloride elastomer, a polystyrene elastomer, a polyethylene elastomer, a polypropylene elastomer, a polyvinyl butyral elastomer, silicone, a thermoplastic elastomer, and combinations thereof.
Thermoplastic elastomers (TPEs) are composite materials obtained from the combination of an elastomeric material and a thermoplastic al. TPEs are meric materials that are dispersed and crosslinked in a continuous phase of a thermoplastic material.
Examples of conventional 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 rs that includes, but is not limited to, polyoxybenzylmethylenglycolanhydride, polyvinyl de, polystyrene, polyethylene, polypropylene, polacrylonitrile, polyvinyl butyral, polylactic acid, and the like. _ 20 _ ] With respect to an article that includes a cloth substrate and a bioceramic composition, the amic composition can be applied to the cloth by any s known in the cloth/fabric art using a liquid or ?uid carrier that contains the bioceramic composition. For example, a silk-screen printing process, a dot application process, a binder solution ation process, a visible repeating pattern process or any other suitable method can be employed. Silk- screen printing is a printing process which uses a form — referred to as a frame or sieve — that includes a fabric with a very ?ne mesh, which is left permeable to the ink in the areas of the image to be reproduced and impermeable in the other areas. A dot application process uses speci?c devices, such as a syringe comprising a bioceramic, to apply the ceramics to particular portions of an apparel. A binder solution application process is used to dip fabrics into solutions or slurs comprising the bioceramics — in some cases this is used to impregnate the fabric with a bioceramic. A Visible repeating pattern process is used to add a single pattern or repetitions of a pattern to an apparel. In one embodiment, the bioceramic composition can be incorporated into an ink, which is then creened onto at least a portion of the surface of the cloth substrate.
In r embodiment, the bioceramic ition is ed with one or more liquid polymers (e.g. polyester and/or the like). The bioceramic/polymer composition is then extruded using methods known in the art to form ?bers that are used in preparing a cloth substrate.
Cloth substrates useful herein include fabric or textile substrates prepared by any method known to one of skill in the cloth fabrication art. Such techniques include, but are not limited to, weaving, knitting, crocheting, felting, knotting, g, and the like. Suitable ng materials for the cloth substrates include natural or synthetic (e. g. polymeric) ?bers and ?laments. In one embodiment, the cloth substrate includes, but is not limited to, a material selected from wool, silk, cotton, canvas, jute, glass, nylon, polyester, c, elastane, polychloroprene, expanded polytetra?uoroethylene-containing laminate fabrics (e. g. Gore-Tex® fabric), and combinations thereof.
With t to an article that includes a metallic substrate, the bioceramic composition is optionally applied to the metal in a liquid/?uid form by any s known in the metal processing art. For example, the bioceramic composition is ally incorporated into a liquid/?uid carrier, such as, but not limited to, a paint, sealant, varnish, and the like, and applied to at least a portion of the surface of the metallic substrate. The amount of bioceramic composition added to a paint or other /?uid carrier can be any suitable amount.
Suitable metallic substrates for use herein include any metallic substrate that is useful for preparing an article that incorporates a bioceramic composition. Exemplary metallic substrates _ 21 _ include pure metals and alloys. In one embodiment, the metallic substrate is selected from zinc, molybdenum, cadmium, um, titanium, vanadium, chromium, manganese, iron, cobalt, nickel, copper, zirconium, niobium, ruthenium, rhodium, palladium, silver, tantalum, tungsten, rhenium, osmium, m, platinum, gold, aluminum, gallium, indium, tin, and the like.
Virtually any article that a bioceramic ition can be applied to or incorporated within is suitable. In one embodiment, the article is ed from apparel (e.g. ts, such as: jewelry, patches (e.g. patches that are fabricated to adhere to skin, such as ermal patches, transdermal hydrogel patches, etc.), adhesive tape, such as kinesio, non- adhesive tape, pads, insoles, performance sleeves, uniforms, casual/leisure wear, bedding, including sheet, mattresses, , pillows, and pillow cases, body supports, supports, foam rollers, lotions, soaps, tape, glassware, furniture, paints, inks, labels, s, mats, food and/or beverage containers, drink koozies (e.g. bottle or can), headware (e. g. helmets, hats, etc.), footwear (e.g. shoes, sneakers, sandals, etc.), earphones, a surface, a sports surface, arti?cial grass, and the like.
In some embodiments, the apparel includes ic apparel, sporting accessories, and sports equipment including, but not limited to, orthotic inserts, athletic shoes, uniforms, footwear, insoles, performance sleeves, diving suits, life vers, shirts, , wrist bands, arm bands, headwear (e.g. skull caps), head bands, gloves, jackets, pants, hats, and backpacks, skis, ski poles, snowboards, oards, in-line skates, bicycles, surf boards, water skis, jet skis, diving equipment, ropes, chains, goggles, and blankets. In some embodiments, the apparel is sporting ories, including but not d to blankets. In some embodiments, the apparel is con?gured for use in orthotic applications, including but not limited to orthotic s, shoes, and the like.
In another embodiment, the article is apparel selected from shirts, pants, shorts, dresses, skirts, jackets, hats, undergarments, socks, caps, gloves, scarves, diapers, and the like. In yet another embodiment, the article is jewelry ed from bracelets, necklaces, earrings, medallions, pendants, rings, and the like. In still another embodiment, the article is bedding selected from blankets, sheets, pillows, pillow cases, comforters, duvet covers, mattress covers, mattress pads, and the like. In another embodiment, the article is a body support selected from knee wraps, elbow supports, compression arm sleeves, compression leg sleeves, wrist wraps, and the like. In some ments, the apparel includes casual/leisure wear.
In further or additional ments, provided is an article that incorporates a bioceramic composition, or an article with a bioceramic d to it, provided that the article is selected from the group consisting of apparel, jewelry, patches, pads, s, bedding, body ts, foam rollers, lotions, soaps, tape, glassware, ?lmiture, paints, inks, , carpets, mats, food and/or beverage containers, drink koozies, headwear, footwear, earphones, and combinations thereof. In r or additional ments, the article comprises apparel such as clothing. In some embodiments, the apparel is a casual/leisure wear apparel. In some ments, the apparel is an athletic apparel. In some embodiments, the apparel comprises a shirt, a jacket, shorts, or trousers. In still further embodiments, the apparel comprises a wrist band, a pad, a knee bracelet, an ankle bracelet, a sleeve, a performance sleeve, headwear (e. g. skull cap), a patch, footwear, or insoles.
In some embodiments, the e is a surface, a sports surface, or arti?cial grass.
Biomodulation Effect Another aspect of the articles, compositions of matter, s, devices, and systems described herein is a bioceramic ition that provides a biomodulatory or physiological effect when heated or exposed to heat, such as human ion. In some embodiments, the biomodulatory or physiological effect comprises: a modulation of pain, an increase in muscle endurance, an increase in stamina, an increase in muscle strength, a modulation of the cardiorespiratory system, such as an increase in respiratory capacity, an increase in ?exibility, a modulation of cellular metabolism, an improvement of analgesia, an anti- oxidative effect, an anti-fibromyalgia , a decrease in in?ammation, a decrease in oxidative stress, a modulation of cytokine levels, a modulation of blood circulation, a reduction in intolerance to a cold environment, a reduction in a symptom of arthritis or vascular disease, an increase in cutaneous perfusion, a decrease in heart rate, a decrease in blood pressure, r recovery from injury or exercise, an esthetic effect such as a reduction in cellulite of the subject, an improvement in the quality of life.
A bioceramic composition of the sure has a ulatory or physiological effect in various subjects. In some embodiments, subjects are humans, non-human primates such as chimpanzees, and other apes and monkey s; farm animals such as cattle, horses, sheep, goats, swine; domestic s such as rabbits, dogs, and cats; laboratory animals including rodents, such as rats, mice and guinea pigs, and the like. A subject can be of any age. In some embodiments, subjects are, for example, elderly adults, adults, adolescents, pre-adolescents, en, toddlers, infants. _ 23 _ In some embodiments, the biomodulatory or physiological effect is a change in body composition. A body composition can be described in terms of body mass index, fat mass index, skeletal muscle mass index, percentage of body fat, or any combinations thereof. Various methods can be used to measure a body composition, such as the bioimpedance is. A bioimpedance analyzer can be used in a bioimpedance is to ate an te of total body water (TBW). TBW can be used to estimate fat-free body mass and, by difference with body weight, body fat.
In some ments, the biomodulatory or physiological effect is an se or a ion in the expression level of a biomarker. Biomarkers broadly refer to any characteristics that are ively measured and evaluated as indicators of normal biological processes, normal muscle function, pathogenic ses, or cologic responses to bioceramics. Unless otherwise noted, the term biomarker as used herein speci?cally refers to biomarkers that have sical properties, which allow their measurements in biological samples (e. g., saliva, plasma, serum, cerebrospinal ?uid, bronchoalveolar lavage, biopsy).
Examples of biomarkers include c acid biomarkers (e.g., oligonucleotides or polynucleotides), peptides or protein biomarkers, cytokines, hormones, or lipids. In some embodiments, an article comprising a bioceramic composition of the disclosure has a biomodulatory or physiological effect on a biomarker.
In some embodiments, a ker is a cytokine. miting examples of cytokines include: a) cytokines in the IL-2 subfamily, for example erythropoietin (EPO) and thrombopoietin (TPO); b) the interferon (IFN) subfamily, for example IFN-y; c) the IL-6 subfamily; d) the IL-lO subfamily; e) the IL-1 subfamily, for example, IL-l and IL-18, f) IL-l7; or g) tumor necrosis factor family, for example tumor necrosis factor alpha (TNF-alpha or TNF- 0L). In some embodiments, an article comprising a bioceramic composition of the disclosure has a biomodulatory or physiological effect on a cytokine. In some embodiments, the cytokine is associated with in?ammation, pain, muscle endurance, a modulation of the cardiorespiratory system, a modulation of cellular metabolism, analgesia, cellular oxidation, ?bromyalgia effect, or another condition described herein.
In some embodiments, a biomarker is a wild-type protein or a protein that has been modi?ed from a native state. For example, protein carbonylation is a type of protein oxidation that can be ed by reactive oxygen species. It usually refers to a process that forms reactive ketones or aldehydes that are amenable to reacting with 2,4- dinitrophenylhydrazine (DNPH) to form hydrazones. Direct oxidation of side chains of lysine, arginine, proline, and threonine residues, among other amino acids, in the "primary protein _ 24 _ carbonylation" reaction produces DNPH detectable protein products. In some embodiments, an article comprising a bioceramic composition of the disclosure has a biomodulatory or physiological effect on a protein. In some embodiments, the protein is associated with in?ammation, pain, muscle nce, a modulation of the cardiorespiratory system, a modulation of cellular metabolism, analgesia, cellular oxidation, ?bromyalgia , or another condition described herein.
In some embodiments, a biomarker is a wild-type lipid or a lipid that has been modi?ed from a native state. For example, lipid peroxidation refers to the oxidative degradation of lipids. It is the process in which free radicals remove electrons from the lipids in cell membranes, resulting in cell damage. In some embodiments, an article comprising a bioceramic composition of the disclosure has a biomodulatory or physiological effect on a lipid. In some embodiments, the lipid is associated with in?ammation, pain, muscle endurance, a modulation of the cardiorespiratory system, a modulation of cellular metabolism, analgesia, ar oxidation, yalgia effect, or another condition described herein.
In some embodiments, the bioceramic composition provides a biomodulatory or logical effect that comprises a change that is statistically signi?cant. In further or additional embodiments, the ulatory or physiological effect ses a change that is at least 5% in the . In some embodiments, the biomodulatory or physiological effect ses a change that is at least 10% in the effect. In still further or additional embodiments, the biomodulatory or physiological effect is pain relief, and the pain is caused by a physical activity. In still further or additional embodiments, the biomodulatory or physiological effect is in?ammation.
The time needed for a bioceramic of the disclosure to modulate the effect of a biomarker often depends on the prevalent quantity, distribution and concentration of the bioceramic in contact with the subject. In some embodiments, a ulatory or physiological effect of a bioceramic of the disclosure is achieved within less than 10 s, less than 1 hour, less than 6 hours, less than 12 hours, less than 24 hours, less than 48 hours, less than 72 hours, less than 1 week, less than 2 weeks, less than 3 weeks, less than 4 weeks, less than 2 months, less than 6 months, or less than 12 months of a use of an apparel comprising a bioceramic.
Adjuvant Therapies A amic of the disclosure can provide numerous therapeutic benefits to a subject wearing an l that ses the bioceramic. The far infrared energy provided by a bioceramic can be helpful for enhancing blood circulation, reducing pain, strengthening the _ 25 _ cardiovascular system, easing joint stiffness and in?ammation, and revitalizing skin cells. The far infra-red energy can provide an analgesic effect to the subject. Examples described in this instant disclosure provide qualitative and quantitative metrics of a amic on numerous physiological parameters. Yet, in some cases, a amic apparel can se another active compound. In other cases, a treatment regimen that utilizes a bioceramic can be administered alongside an adjuvant therapy.
A bioceramic can be formulated with another active compound/substance. In some instances, a bioceramic is formulated with a pharmaceutically active or ve compound that provides a desired smell, sensation, texture. For example an apparel, e.g.: patch, can be ated with one or more additional active or ve substances. The one or more other substances can be, e.g., menthol, cinnamon, peppermint, cayenne pepper (capsaicin), camphor, mustards, medicinal herbs, compounds derived from such herbs, or substitutes thereof. The ratio of agent (e.g., bioceramic) to another nce 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, 3021,2521, 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,]: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 some cases, a bioceramic composition can have an sic effect on a subject that wears an apparel, e.g.: patch, shirt, , etc, comprising the bioceramic. In some cases the analgesic effect is exclusively provided by the bioceramic and the additional substance. A plurality of dosages of active substances such as l, cinnamon, peppermint, cayenne pepper (capsaicin), mustards, medicinal herbs, nds derived from such herbs, or substitutes thereof can be incorporated in an apparel of the disclosure. Non-limiting examples of medicinal herbs and exemplary species include Acai (Euterpe oleracea), Alfalfa (Medicago sativa), Aloe vera (e. g.: Aloe barbadensz's), Amica (Amica montana), aroeira (Schinas terebz’nthz'folz’as), Ashoka tree (Saraca indica), Asthma-plant (Euphorbia hirta), Astragalus (Astragalus qaas), Barberry (Berberis valgarz's), Belladonna (Atropa belladonna), Bilberry (Vaccinz’am myrtz'llas), Bitter gourd (Momordz‘ca charamz'a), Bitter leaf (Vernonz’a amygdalz’na), Bitter orange s >< aarantz‘am), Boswellia llia serrata), Black cohosh (Actaea racemosa), d thistle (Cm'cas benedictas), Blueberries (genus ’am), Burdock (Arctium lappa), bugweed (Solanam maarz'tz'anam), Cat’s claw (Uncarz’a tomentosa), Cayenne cum annaum), Celery (Apiam graveolens), Chamomille (e.g.: Matricaria recutita and Anthemis nobilis), Chaparral (Larrea tridentata), Chasteberry (Vitex agnus—castus), Chili (Capsicum cens), Cinchona (genus of about 38 species of trees whose bark is a source of alkaloids, including quinine), Clove (Syzygz'am aromaticam), Coffee senna (Cassia occidentalis), Comfrey (Symphytum o?‘zcz’nale), _ 26 _ Cranberry niam macrocarpon), Dandelion (Taraxacum o?icinale), Digitalis (Digitalis lanata), Dong quai (Angelica sinensis), Elderberry (Sambucas nigra), Ephedra (Ephedra sinica), Eucalyptus (Eucalyptus globalas), European Mistletoe (Viscam album), Evening primrose (Oenothera spp.), Fenugreek (Trigonellafoenum-graecam), Feverfew (Tanacetam partheniam), Flaxseed (Linam asitatissimum), Garlic m sativam), Ginger (Zingiber o?icinale), Ginkgo (Ginkgo biloba), Ginseng (Panax ginseng and Panax quinqaefolias), Goldenseal (Hydrastis canaalensis), Green Tea (Camellia sinensz's), Grape (Vitis vinifera), Guava (Psidiam gaajava), Hawthorn (speci?cally Crataegas monogyna and Crataegus laevigata), Henna (Lawsonia s), Hoodia (H00a’ia gora’oniz’), Horse chestnut (Aesculus hippocastanum), Horsetail (Equisetam e), Jamaica d (Piscz'dz'a erythrz'na / Piscz'dz'a piscipula), Lavender (Lavana’ala angastifolia), Lemon (Citrus limon), Licorice root (Glycyrrlziza glabra), Lotus (Nelambo nacifera), Marigold (Calendula o?icinalis), Marsh-mallow (Althaea o?icinalis), Noni (Morina’a citrifolia), Opium Poppy (Papaver somnifemm), Oregano num vulgare), Peppermint (Mentha x ta), Polygala (Paniculata L), Podo?lox (podo?lox), Sucupira (Pterodon emarginatas), Summer savory (Satureja horrensis), Thunder God Vine (Tripterygiam wilfordii), Turmeric (Carcama , Willow Bark (Salix alba), and White willow (Salix alba).
In some cases, a amic ition can have an anti-in?ammatory effect on a subject that wears an apparel, e.g.: patch, shirt, shorts, etc, comprising the bioceramic. In some cases the anti-in?ammatory effect is provided by a combination of the bioceramic and an additional substance. A plurality of dosages of anti-in?ammatory substances can be incorporated in an apparel of the disclosure. Non-limiting examples of substances, medicinal herbs of origin, and exemplary species that can e an anti-in?ammatory effect include Alfalfa Alfalfa (Medicago sativa L.), Aloe Vera Gel (Aloe Vera Gel, Aloe vera), Andiroba Oil (Carapa nsis), Ashwagandha root, (Witham’a somnifera), Balm of Gilead (Papalas spp), Balsam of Peru (Myroxylon pereirae), ry (Berberis vulgaris L), Barley Grass (Hordeam e), ry niam myrtillas), Birch bark & leaf (Betala alba), Black Seed oil (Nigella ), Boneset (Eapatoriam perfolialam), Borage Seed Oil (Borago alis), Boswellia incense), lia (Frankincense), Boswellia thurifera, Bupleurum (Bupleurum chinense), Calendula (Calendula o?icinalis), Cat’s Claw (Uncaria tomentosa), ile (Matricaria recutz’ta), Chickweed (Stellaria media), Chicory root (Ciclzoriam inlybas), Chrysanthemum (Chrysanthemum morifolium, C. e), Cilantro (Coriandram sativam), Copaiba Balsam (Copaifera O?icinalis), Coptis (Coptis spp), Corn Silk (Zea mays), Comflowers (Centaurea cyanas), Cumin (Cuminum cyminum), Devil’s Claw (Harpagophytam procambens), Echinacea (Echinacea angustifolia), Feverfew (Tanacetam _ 27 _ parthenium), Figwort (Scrophularia nodosa), Ginkgo biloba (Ginkgo biloba L.), Grindelia (Grindelia spp), Immortelle Oil (Helichrysum angustz'folium), Jamaican Dogwood (Piscz'dz'a pula), Joe-pye weed (Eupatorium purpureum), Marsh Mallow Root (Althaea o?‘zcz’nalis L.), Mullein (Verbascum spp.), Oats (Avena sativa L.), Oregon Grape root (Mahom'a aquz’folz’um), Pineapple (Ananas comosus), Sarsaparilla Root (Smilax sarsaparz'lla), Sea Buckthom Oil (Hz'ppophae rhamnoides), Shea Nut Butter ospermum parkiz'), Soapwort (Saponarz'a nalz's), Spikenard (Aralz‘a racemosa), Spilanthes nthes acmella), Tamanu Oil (Calophyllum inophyllum), Turmeric (Curcuma longa L), White Peony root (Paeonz'a albl'?ora), White Willow Bark (Salix Alba), Wild Cherry Bark (Prams serotz’na), Witch Hazel (Hamamelz’s virginiana), Yarrow (Achillea millefolz'um), and Yucca Root (Yucca spp).
In some cases, the active substance is an analgesic. In some cases the plurality of sis?oniaboutlIngtoabout20001ng;?on1about5IngtoaboutlOOOrng,?on1about10 mg to about 25 mg to 500 mg, from about 50 mg to about 250 mg, from about 100 mg to about 200 mg, from about 1 mg to about 50 mg, from about 50 mg to about 100 mg, from about 100 mg to about 150 mg, from about 150 mg to about 200 mg, from about 200 mg to about 250 mg, from about 250 mg to about 300 mg, from about 300 mg to about 350 mg, from about 350 mg to about 400 mg, from about 400 mg to about 450 mg, from about 450 mg to about 500 mg, from about 500 mg to about 550 mg, from about 550 mg to about 600 mg, from about 600 mg to about 650 mg, from about 650 mg to about 700 mg, from about 700 mg to about 750 mg, from about 750 mg to about 800 mg, from about 800 mg to about 850 mg, from about 850 mg to about 900 mg, from about 900 mg to about 950 mg, or from about 950 mg to about 1000 mg. In some cases, the plurality of times occurs is administered to a subject with a treatment regimen that occurs over a period of time. The period oftime can be about, at least or at most 30 seconds, 1, 2, 3, 4, , 6, 7, 8, 9, 10, ll, l2, l3, 14, 15, 16,17,18,l9, or 20 minutes.
In addition to the s of using apparel sing bioceramics on their own, subjects can combine additional treatment regimens with the use of a bioceramic apparel as co- adjuvant therapies. For e, physical therapy can be used as an adjuvant therapy treatment for a bioceramic treatment regimen. Further examples of adjuvant therapies include physical therapy, physical litation, hydrotherapy, s, or another suitable complementary therapy.
An adjuvant therapy regimen can be ibed to a subject concomitantly of concurrently with a therapy regimen involving a use of a bioceramic apparel. An adjuvant y regimen can be carried out in many settings, such as in the home of a subject, in ?tness centers and sports ng facilities, in outpatient clinics or of?ces, health and wellness clinics, _ 28 _ rehabilitation hospitals facilities, nursing facilities, extended care facilities, private homes, education and research centers, schools, hospices, aces or other environments.
Non-Invasive Methods of Providing Biomodulation to a Subject ] Another aspect of the subject matter described herein is a non-invasive method of ing a biomodulatory or physiological effect in or to a subject comprising contacting an article sing a bioceramic to the skin of the subject, provided that when heated or exposed to heat, the bioceramic composition provides far infrared thermal radiation and a biomodulatory or physiological effect to the t in a non-invasive manner.
For example, in some embodiments, provided is a bioceramic composition that when heated or exposed to heat provides a ulatory or physiological effect when the article is applied to a subject, comprising: a. about 20 wt % to about 80 wt % kaolinite (AlZSi205(OH)4); b. about 1 wt % to about 30 wt % tourmaline; c. about 1 wt % to about 40 wt % aluminum oxide (A1203); (1. about 1 wt % to about 40 wt % silicon dioxide (SiOz); and e. about 1 wt % to about 20 wt % zirconium oxide (ZrOz); provided that the amounts are by total weight of the bioceramic ition.
In further or additional embodiments, provided is a bioceramic composition of matter 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 wt % to about 60 wt % kaolinite (A128i205(OH)4); b. about 5 wt % to about 15 wt % tourmaline; c. about 15 wt % to about 25 wt % aluminum oxide (A1203); d. about 10 wt % to about 20 wt % n dioxide (SiOz); and e. about 1 wt % to about 20 wt % zirconium oxide (ZI‘Oz); provided that the amounts are by total weight of the bioceramic composition. In some embodiments, the bioceramic composition comprises kaolinite in a range from about 45 wt % to about 55 wt %. In further or onal embodiments, provided is a amic composition that comprises kaolinite in the range from about 47 wt % to about 53 wt %. In r or onal embodiments, provided is a bioceramic composition that contains kaolinite in a range from about 48 wt % to about 52 wt %.
In some embodiments, provided is a bioceramic composition that comprises a. about 50 wt % kaolinite (A128i205(OH)4); _ 29 _ b. about 10 wt % tourmaline; c. about 18 wt % aluminum oxide (A1203); (1. about 14 wt % silicon dioxide (SiOz); and e. about 8 wt % zirconium oxide (ZrOz).
In some embodiments, the biomodulatory or physiological effect comprises: a modulation of pain, an increase in muscle endurance, a modulation of the cardiorespiratory system, a modulation of cellular metabolism, analgesia, an anti—oxidative , an anti- algia effect, a decrease in in?ammation, a decrease in oxidative stress, a decrease in endoplasmic reticulum stress, a modulation of cytokine levels, a tion of blood circulation, a reduction in intolerance to a cold environment, a reduction in a symptom of arthritis or vascular disease, an increase in cutaneous ion, a decrease in heart rate, a decrease in blood pressure, an esthetic effect, such as reduction of body measurements, reduction of weight, or a reduction in cellulite of the subject.
In some embodiments, the amic ition es a biomodulatory or physiological effect that comprises a change that is statistically signi?cant. In further or additional embodiments, the biomodulatory or physiological effect ses a change that is at least 5% in the effect. In some ments, ] In some embodiments, provided is an article that incorporates a bioceramic composition, or an article with a bioceramic applied to it, provided that the article is ed from the group consisting of apparel, jewelry, patches, pads, insoles, bedding, body supports, foam rollers, lotions, soaps, tape, are, furniture, paints, inks, labels, carpets, mats, food and/or beverage containers, drink koozies, headwear, footwear, earphones, and combinations thereof. In further or additional embodiments, the article comprises apparel such as clothing. In some embodiments, the apparel comprises a shirt, a , shorts or trousers. In still further embodiments, the apparel comprises a wrist band, a pad, a knee bracelet, an ankle bracelet, a sleeve, or a patch. In some embodiments, the article comprises a surface, a sports surface, or artificial grass.
A amic composition of the ion can be a combination of any nds described herein with other chemical components, such as carriers, stabilizers, diluents, dispersing agents, suspending agents, thickening agents, and/or excipients. The bioceramic can be administered directly or indirectly to the skin of a subject. In some cases, the active compounds can be applied to an e and exposed to a subject indirectly. In other cases, the active compounds can be applied directly to the skin of a subject.
Methods of Manufacture Another aspect of the subject matter described herein is a method of preparing an article comprising the steps of: a. preparing a bioceramic solution; and b. applying the solution to the article; provided that the solution, when applied to the article, comprises about 20 wt % to about 80 wt % kaolinite (A128i205(OH)4); about 1 wt % to about 30 wt % tourmaline; about 1 wt % to about 40 wt % aluminum oxide (A1203); about 1 wt % to about 40 wt % silicon dioxide (8102); and from about 1 wt % to about 20 wt % zirconium oxide (Zr02) further provided that the s are by total weight of the amic composition. In further or additional ments, provided is a method for ing an article comprising the steps of: a. preparing a bioceramic solution; and b. applying the solution on the article; provided that when heated or exposed to heat, the bioceramic provides a biomodulatory or physiological effect when the article is applied to a subject. In further or additional embodiments, ed is a method aring an article whereby a solution is applied to the article by a spraying technique to an inside or an outside of the article. In some embodiments, a solution is applied to the e by a silk screening technique, a dot application technique, a binder solution application method, a visible repeating pattern approach or any other suitable method to the inside or the outside of the article optionally with use of a dye. In further or additional embodiments, an ink is not used in the method. In some embodiments, a solution is applied to the article by g or immersing the article in a slurry or solution. In ular embodiments, bioceramic solution comprises a r. In some embodiments, the polymer comprises a silicone polymer. In further or additional embodiments, a solution is applied to an inside of the article, an outside of an article, or a speci?c area of the article. In one embodiment, a solution is applied as small dots on the article.
For example, in some embodiments, the bioceramic comprises: a. about 20 wt % to about 80 wt % kaolinite (A1281205(OH)4); b. about 1 wt % to about 30 wt % tourmaline; 0. about 1 wt % to about 40 wt % um oxide (A1203); (1. about 1 wt % to about 40 wt % silicon dioxide (8102); and e. about 1 wt % to about 20 wt % zirconium oxide (ZrOz); provided that the amounts are by total weight of the bioceramic composition.
] In further or additional embodiments, provided the bioceramic composition comprising: a about 40 wt % to about 60 wt % kaolinite (Alzsi205(OH)4); b. about 5 wt % to about 15 wt % tourmaline; c. about 15 wt % to about 25 wt % aluminum oxide (A1203); d. about 10 wt % to about 20 wt % silicon dioxide (SiOz); and e. about 1 wt % to about 20 wt % zirconium oxide (ZI‘Oz); provided that the amounts are by total weight of the amic composition. In some embodiments, the bioceramic composition comprises kaolinite in a range from about 45 wt % to about 55 wt %. In r or additional embodiments, provided is a amic composition that comprises kaolinite in the range from about 47 wt % to about 53 wt %. In further or additional embodiments, provided is a bioceramic composition that contains kaolinite in a range from about 48 wt % to about 52 wt %.
In some embodiments, ed is a bioceramic composition that comprises a. about 50 wt % kaolinite (AlgSi205(OH)4); b. about 10 wt % tourmaline; c. about 18 wt % aluminum oxide (A1203); d. about 14 wt % silicon dioxide (SiOz); and e. about 8 wt % zirconium oxide (ZrOz).
In some embodiments, the bioceramic composition comprises tourmaline which comprises NaFe2+3Al6Si6O18(B03)3(OH)30H.
In one ment, the article is apparel selected from shirts, pants, , dresses, skirts, jackets, hats, undergarments, socks, caps, gloves, scarves, diapers, and the like. In yet r embodiment, the article is jewelry ed from bracelets, necklaces, gs, medallions, pendants, rings, and the like. In still another embodiment, the article is bedding selected from blankets, sheets, pillows, pillow cases, comforters, duvet covers, mattress covers, mattress pads, and the like. In another embodiment, the article is a body support selected from knee wraps, elbow ts, compression arm sleeves, compression leg sleeves, wrist wraps, and the like.
In further or onal embodiments, provided is an e that incorporates a bioceramic composition, or an article with a bioceramic applied to it, provided that the article is selected from the group consisting of apparel, y, patches, pads, insoles, bedding, body supports, foam rollers, lotions, soaps, tape, glassware, furniture, paints, inks, labels, carpets, mats, food and/or beverage containers, drink koozies, headwear, footwear, earphones, and _ 32 _ combinations thereof. In r or additional embodiments, the article comprises apparel such as clothing. In some embodiments, the apparel ses a shirt, a jacket, shorts or trousers. Ion still ?rrther embodiments, the l comprises a wrist band, a pad, a knee bracelet, an ankle bracelet, a , or a patch.
Optionally, articles further include one or more additional frequencies imprinted on the e 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 (e.g. ProWave 101; F-Scan2; TrueRife F-117; Wellness Pro 2010; Global Wellness; GB4000; GB4000 BCX Ultra; and the like. In l, frequency tors produce selected frequencies that are then transmitted through a connecting cable to a commercially available frequency imprinting plate (e. g. SP9 or SP12 vortex frequency imprinting ). In one embodiment, the frequency or frequencies range from about 0.05 Hz to about 20 MHz. In another embodiment, the frequency or frequencies range from about 5 Hz to about 5 MHz. In a further embodiment, the frequency or frequencies range from about 100 Hz to about 0.1 MHz. In yet another embodiment, the frequency or frequencies range from about 1 KHz to about 10 KHz. The article to be imprinted with the selected frequency or frequencies is exposed to the frequency emitted by the tor. To accomplish this, the article may be placed on the imprinting plate and exposed to the signal of the selected frequency or frequencies for imprinting. In one embodiment, the imprinting s takes about 5-10 minutes per cycle depending upon the amount of frequencies to be imprinted and the selected imprinting program. In another embodiment, the imprinting s takes about 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, or 10 minutes per cycle depending upon the amount of frequencies to be imprinted and the selected imprinting program. Imprinted articles may transmit the frequency ts to a user upon t in ction with the waves emitted from the amic composition that is incorporated into the ] In some embodiments, the method of manufacturing an article comprising a bioceramic of the disclosure comprises a silicon based approach. Silicones are typically inert synthetic compounds. A silicone g is, for example, and ink, paint, oil, film, coat, grease, or resin that is silkscreened, sprayed, or otherwise directly applied to an article of the disclosure. In some embodiments, a silicone coating is pre-mixed with a bioceramic prior to being applied to an apparel. In some embodiments, a silicone coating is applied over a bioceramic as a ?lm. In some embodiments, a silicone is mixed with a concentration of a bioceramic composition, wherein the mix provides a biomodulatory or physiological effect to a subject. In some _ 33 _ embodiments, a higher tration of a bioceramic is mixed with a silicone as ed to a concentration of a bioceramic that can be effectively mixed with an ink or a gel. In some embodiments, up to 50% more bioceramic is mixed with a silicone as compared to an ink or a In some embodiments, a amic composition of the disclosure is mixed at a ratio of about 1 part bioceramic to about 1 part silicone, about 1 part bioceramic to about 2 parts silicone, about 1 parts bioceramic to about 3 parts silicone, about 1 part bioceramic to about 4 parts silicone, about 1 part bioceramic to about 5 parts ne, about 1 part bioceramic to about 6 parts silicone, about 1 part bioceramic to about 7 parts silicone, about 1 part amic to about 8 parts silicone, about 1 part bioceramic to about 9 parts silicone, about 1 part bioceramic to about 10 parts silicone, about 1 part bioceramic to about 11 parts silicone, about 1 part bioceramic to about 12 parts silicone, about 1 part bioceramic to about 13 parts silicone, about 1 part bioceramic to about 14 parts silicone, about 1 part bioceramic to about 15 parts silicone, about 1 part bioceramic to about 16 parts silicone, about 1 part bioceramic to about 17 parts silicone, about 1 part bioceramic to about 18 parts silicone, about 1 part amic to about 19 parts silicone, about 1 part bioceramic to about 20 parts silicone, about 1 part bioceramic to about 21 parts silicone, about 1 part bioceramic to about 22 parts ne, about 1 part bioceramic to about 23 parts silicone, about 1 part bioceramic to about 24 parts silicone, about 1 part bioceramic to about 25 parts silicone, about 1 part amic to about 26 parts silicone, about 1 part bioceramic to about 27 parts silicone, about 1 part bioceramic to about 28 parts silicone, about 1 part bioceramic to about 29 parts silicone, about 1 part bioceramic to about 30 parts silicone, about 1 part amic to about 31 parts ne, about 1 part bioceramic to about 32 parts silicone, about 1 part bioceramic to about 33 parts silicone, about 1 part bioceramic to about 34 parts silicone, about 1 part bioceramic to about 35 parts silicone, or another suitable ratio.
In some ments, a bioceramic composition of the disclosure is mixed at a ratio of about 1 part bioceramic to about 1 part silicone, about 2 parts bioceramic to about 1 part silicone, about 3 parts bioceramic to about 1 part silicone, about 4 parts bioceramic to about 1 part silicone, about 5 parts bioceramic to about 1 part silicone, about 6 parts bioceramic to about 1 part silicone, about 7 parts bioceramic to about 1 part silicone, about 8 parts bioceramic to about 1 part silicone, about 9 parts amic to about 1 part silicone, about 10 parts bioceramic to about 1 part silicone, about 11 parts bioceramic to about 1 part silicone, about 12 parts bioceramic to about 1 part silicone, about 13 parts bioceramic to about 1 part silicone, about 14 parts bioceramic to about 1 part silicone, about 15 parts bioceramic to about 1 part silicone, about 16 parts bioceramic to about 1 part silicone, about 17 parts bioceramic to about 1 part silicone, _ 34 _ about 18 parts bioceramic to about 1 part silicone, about 19 parts bioceramic to about 1 part silicone, about 20 parts bioceramic to about 1 part silicone, about 25 parts amic to about 1 part silicone, about 26 parts bioceramic to about 1 part silicone, about 27 parts bioceramic to about 1 part silicone, about 28 parts bioceramic to about 1 part silicone, about 29 parts amic to about 1 part silicone, about 30 parts bioceramic to about 1 part silicone, about 31 parts bioceramic to about 1 part silicone, about 32 parts amic to about 1 part silicone, about 33 parts amic to about 1 part silicone, about 34 parts bioceramic to about 1 part silicone, about 35 parts bioceramic to about 1 part silicone, or another suitable ratio.
In some embodiments, the method of manufacturing an article sing a bioceramic of the disclosure comprises a dot application approach. In a dot application method of manufacturing, a dot comprising a bioceramic, either alone or in combination with a matrix is applied to an article. In some embodiments, a matrix is, for example, a silicon matrix, a polymer matrix, or a gel matrix. In some embodiments, a polymer matrix is an innocuous holder of the bioceramic. In some embodiments, a polymer matrix has an active function in determining the amount of infrared energy that is re?ected by a bioceramic. In some embodiments, the polymer is adhesive. In some embodiments, a polymer is used to glue a bioceramic ition to a fabric. s polymers can be mixed with a bioceramic of the disclosured and applied to an article, including, for example, silicone, hydrogels such as crosslinked poly(vinyl alcohol) and ydroxy ethylmethacrylate), acyl substituted cellulose acetates and alkyl derivatives thereof, partially and completely hydrolyzed alkylene-vinyl acetate copolymers, unplasticized polyvinyl chloride, crosslinked homo- and copolymers of polyvinyl acetate, crosslinked polyesters of acrylic acid and/or methacrylic acid, polyvinyl alkyl ethers, polyvinyl ?uoride, polycarbonate, polyurethane, polyamide, polysulphones, styrene acrylonitrile copolymers, crosslinked poly(ethylene oxide), poly(alkylenes), poly(vinyl imidazole), poly(esters), poly(ethylene thalate), polyphosphazenes, and chlorosulphonated polyole?nes, and combinations thereof. In some embodiments the polymer ses ethylene vinyl e.
In some embodiments, the method of manufacturing an article sing a bioceramic of the sure comprises a binder or solution application approach. In some embodiments, the bioceramic composition is sprayed or dipped on an article, for example a shirt, a pad, or a e. In some embodiments, a binder is the rming component of a bioceramic paint. In some cases, a binder comprises materials that impart adhesion of the bioceramic to the apparel and strongly in?uence properties such as glossiness, durability, ?exibility, and resilience of the applied bioceramic. In some embodiments, binders include _ 35 _ synthetic or natural resins such as alkyls, acrylics, vinyl-acrylics, Vinyl acetate/ethylene (VAE), polyurethanes, ters, melamine resins, epoxy, or oils.
Further non-erodible materials suitable for inclusion in a apparel with a bioceramic include, for example, proteins such as zein, n, collagen, gelatin, casein, silk, wool, polyesters, polyorthoesters, polyphosphoesters, polycarbonates, polyanhydrides, polyphosphazenes, polyoxalates, polyaminoacids, polyhydroxyalkanoates, polyethyleneglycol, polyvinylacetate, polyhydroxyacids, hydrides, els including poly(hydroxyethy1 methylacrylate), polyethylene , -isopropylacrylamide), po1y(N—Viny1pyrrolidone), cellulose polyvinyl alcohol, silicone hydrogels, polyacrylamides, and polyacrylic acid.
In some embodiments, the method of manufacturing an article comprising a bioceramic of the disclosure comprises a Visible repeating pattern process. A method of Visible repeating patterns often comprises a ?rst step of printing, silk screening, spraying, or using another method to apply a pattern with regular ink (without a bioceramic) on an apparel. A method of Visible repeating ns often comprises a second step of applying a second material, such as a spray, a silicone, or a binder base comprising a bioceramic over the ?rst pattern. A method of Visible repeating patterns can optionally use any of the aforementioned materials, ing nes, binders, and polymers.
The methods of manufacture described herein are used to apply a bioceramic at a speci?c location within an apparel or throughout the apparel. For instance, a method of manufacture disclosed herein can be used to apply a bioceramic to an inner side, to an outer side, or any inner/outer combination of an l. In most embodiments, application of a bioceramic to an inner side, an outer, or any inner/outer combination of an apparel does not affect a biomodulatory or physiological effect of a bioceramic.
In some ments, an apparel ses about 5 % bioceramics by total weight, about 10 % bioceramics by total weight, about 15 % bioceramics by total weight, about % bioceramics by total weight, about 25 % bioceramics by total , about 30 % bioceramics by total weight, about 35 % bioceramics by total weight, about 40 % bioceramics by total weight, about 45 % bioceramics by total weight, about 50 % bioceramics by total weight, about 55 % bioceramics by total weight, about 60 % bioceramics by total weight, about 65 % bioceramics by total weight, about 70 % bioceramics by total weight, about 75 % bioceramics by total weight, about 80 % bioceramics by total weight, about 85 % bioceramics by total weight, about 90 % bioceramics by total weight, or about 95% amics by total weight.
In some embodiments, a bioceramic is applied to a n or to the entire surface of l. In some cases, a bioceramic composition is applied to greater than I % of the surface _ 36 _ area, greater than 5 % of the surface area, r than 10 % of the surface area, greater than 15 % of the surface area, greater than 20 % of the surface area, greater than 25 % of the surface area, greater than 30 % of the surface area, greater than 35 % of the surface area, greater than 40 % of the surface area, greater than 45 % of the e area, greater than 50 % of the surface area, greater than 55 % of the surface area, greater than 60 % of the surface area, greater than 65 % of the surface area, greater than 70 % of the surface area, greater than 75 % of the surface area, greater than 80 % of the surface area, greater than 85 % of the surface area, greater than 90 % of the surface area, r than 95 % of the e area, or greater than 99 % of the surface area of an apparel.
In some cases, a bioceramic composition is applied to no more than 1 % of the surface area, no more than 5 % of the surface area, no more than 10 % of the surface area, no more than 15 % of the surface area, no more than 20 % of the surface area, no more than 25 % of the surface area, no more than 30 % of the surface area, no more than 35 % of the surface area, no more than 40 % of the surface area, no more than 45 % of the surface area, no more than 50 % of the e area, no more than 55 % of the surface area, no more than 60 % of the surface area, no more than 65 % of the surface area, no more than 70 % of the surface area, no more than 75 % of the surface area, no more than 80 % of the surface area, no more than 85 % of the surface area, no more than 90 % of the surface area, no more than 95 % of the surface area, or no more than 99 % of the surface area of an apparel.
In some cases, a bioceramic composition is applied to about 1 % of the surface area, about 2 % of the surface area, about 3 % of the surface area, about 4 % of the surface area, about 5 % of the e area, about 6 % of the surface area, about 7 % of the surface area, about 8 % of the surface area, about 9 % of the surface area, about 10 % of the surface area, about 11 % of the surface area, about 12 % of the surface area, about 13 % of the surface area, about 14 % of the surface area, about 15 % of the surface area, about 16 % of the surface area, about 17 % of the surface area, about 18 % of the e area, about 19 % of the surface area, about 20 % of the surface area, about 21 % of the surface area, about 22 % of the surface area, about 23 % of the e area, about 24 % of the surface area, about 25 % of the e area, about 26 % of the e area, about 27 % of the surface area, about 28 % of the surface area, about 29 % of the surface area, about 30 % of the surface area, about 31 % of the surface area, about 32 % of the e area, about 33 % of the surface area, about 34 % of the surface area, about 35 % of the surface area, about 36 % of the surface area, about 37 % of the surface area, about 38 % of the surface area, about 39 % of the surface area, about 40 % of the surface area, about 41 % of the surface area, about 42 % of the surface area, about 43 % of the surface area, about 44 % of _ 37 _ the surface area, about 45 % of the e area, about 46 % of the surface area, about 47 % of the surface area, about 48 % of the surface area, about 49 % of the surface area, about 50 % of the surface area, about 51 % of the surface area, about 52 % of the e area, about 53 % of the surface area, about 54 % of the surface area, about 55 % of the surface area, about 56 % of the surface area, about 57 % of the surface area, about 58 % of the surface area, about 59 % of the surface area, about 60 % of the surface area, about 61 % of the surface area, about 62 % of the surface area, about 63 % of the surface area, about 64 % of the surface area, about 65 % of the e area, about 66 % of the surface area, about 67 % of the surface area, about 68 % of the surface area, about 69 % of the surface area, about 70 % of the surface area, about 71 % of the surface area, about 72 % of the surface area, about 73 % of the surface area, about 74 % of the surface area, about 75 % of the surface area, about 76 % of the surface area, about 77 % of the surface area, about 78 % of the surface area, about 79 % of the surface area, about 80 % of the surface area, about 81 % of the surface area, about 82 % of the surface area, about 83 % of the surface area, about 84 % of the surface area, about 85 % of the surface area, about 86 % of the surface area, about 87 % of the surface area, about 88 % of the surface area, about 89 % of the e area, about 90 % of the surface area, about 91 % of the e area, about 92 % of the surface area, about 93 % of the surface area, about 94 % of the surface area, about 95 % of the surface area, about 96 % of the surface area, about 97 % of the surface area, about 98 % of the surface area, about 99 % of the surface area, or about 100 % of the e area of an apparel.
Cosmetic Applications In some aspects, the t invention relates to a ic composition comprising a composite powder, foam, liquid, oil, wax, base, or emulsifying agent that comprises a far-infrared emitting bioceramic. The cosmetic compositions of the invention can comprise an effective amount of a bioceramic in various cosmetic vehicles, such as a cosmetic , cream, mascara, mask, gel patch, and general make—up. A ic ition of the disclosure can comprise various ratios of bioceramics to cosmetic vehicle. For instance, a composition of the disclosure can be 1 part bioceramic 1 part cosmetic vehicle, 1 part bioceramic 2 parts cosmetic vehicle, 1 part bioceramic 3 parts cosmetic e, 1 part bioceramic 3 parts cosmetic vehicle, 1 part bioceramic 4 parts cosmetic vehicle, 1 part bioceramic 5 parts cosmetic vehicle, 1 part bioceramic 6 parts ic vehicle, 1 part bioceramic 7 parts cosmetic vehicle, 1 part bioceramic 8 parts ic vehicle, 1 part bioceramic 9 parts cosmetic vehicle, 1 part bioceramic 10 parts cosmetic vehicle, 1 part bioceramic 11 parts cosmetic vehicle, 1 part bioceramic 12 parts cosmetic vehicle, 1 part bioceramic 13 parts cosmetic vehicle, 1 part _ 38 _ bioceramic 14 parts cosmetic vehicle, 1 part bioceramic 15 parts cosmetic vehicle, 1 part bioceramic 16 parts cosmetic vehicle, 1 part bioceramic 17 parts cosmetic vehicle, 1 part bioceramic 18 parts cosmetic vehicle, 1 part bioceramic 19 parts cosmetic e, 1 part bioceramic 20 parts cosmetic vehicle, 1 part bioceramic 21 parts cosmetic vehicle, 1 part bioceramic 22 parts cosmetic e, 1 part bioceramic 23 parts cosmetic vehicle, 1 part bioceramic 24 parts cosmetic vehicle, 1 part bioceramic 25 parts ic vehicle, 1 part bioceramic 26 parts cosmetic vehicle, 1 part bioceramic 27 parts cosmetic vehicle, 1 part amic 28 parts cosmetic vehicle, 1 part bioceramic 29 parts cosmetic vehicle, 1 part bioceramic 30 parts cosmetic vehicle, or another suitable ratio. In some cases, a bioceramic composition of the disclosure can be applied directly to the skin.
Another aspect of the subject matter described herein are cosmetic compositions, and more particularly cosmetic compositions for reducing facial expression marks, scars, blemishes on the skin, as well as for eye puf?ness reduction/control. A cosmetic composition effective for reducing facial expression marks, scars, redness of blemishes on the skin, as well as for eye puf?ness reduction/control may be prepared by addition of a bioceramic to a cosmetic composition such as a lotion, cream, mascara, mask, gel patch, oil, base, wax, emulsifying agents, or general make-up powders with various colors. The cosmetic compositions provide a beneficial biomodulatory effect by ing far-infrared energy that reduces facial expression marks on the skin, reduces eye ss, and reduces blemishes thereby making skin marks less obvious.
A composition of the disclosure can be d to various skin types. Skin types include normal, oily, dry, sensitive, and combination skin types. Some people also have a combination of skin types in ent areas of their skin. A composition of the disclosure can be applied to skin types that vary in a) water content, which s skin’s comfort and elasticity; b) oil (lipid) content, which can affect skin’s ss; and c) sensitivity level. A cosmetic composition of the disclosure can e bene?cial far-infrared radiation to various types of skins. For ce, when exposed to drying factors, skin can crack, peel, or become itchy, irritated, or in?amed. A cosmetic composition of the sure can help alleviate the itchiness, irritation, soreness, or in?ammation.
A ition of the disclosure can be applied directly or indirectly to the skin.
For instance, a far-infrared emitting bioceramic can be formulated inside an eye mask, and the eye mask can be worn by a subject to reduce a puf?ness of the eye. A far-infrared emitting bioceramic can be stered topically and can be ated into a variety of topically administrable compositions, such as solutions, suspensions, lotions, gels, pastes, medicated _ 39 _ sticks, balms, creams, and ointments. Such pharmaceutical compositions can contain solubilizers, stabilizers, tonicity enhancing agents, buffers and preservatives.
A far-infrared emitting bioceramic can be formulated as an oil or emulsion.
Suitable lipophilic solvents or es that can be formulated with a bioceramic described herein include fatty oils such as sesame oil, or tic fatty acid esters, such as ethyl oleate or triglycerides, or liposomes. Aqueous suspensions can contain substances which increase the viscosity of the suspension, such as sodium carboxymethyl cellulose, sorbitol, or dextran. The suspension can also contain le stabilizers or agents which increase the solubility of the nds to allow for the preparation of highly concentrated solutions. Alternatively, the active bioceramic ingredient can be in powder form for constitution with a suitable vehicle, e.g, sterile pyrogen-free water, before use.
In some cases, transdermal patches can provide controlled red of far- infrared energy to a subject. For instance, the rate of far-infrared absorption can be slowed by using rate-controlling membranes or by ng the compound within a polymer matrix or gel.
Conversely, absorption enhancers can be used to se absorption or far-infrared . An absorption enhancer or carrier can include absorbable pharmaceutically acceptable solvents to assist passage through the skin. For e, ermal devices can be in the form of a bandage comprising a backing member, a reservoir containing compounds and carriers, a rate controlling barrier to deliver the compounds to the skin of the subject at a controlled and predetermined rate over a prolonged period of time, and adhesives to secure the device to the skin.
Generally, a ng agent and/or a resin can be used along with a bioceramic composition in a cosmetic ation. A variety of coloring agents and resins can be used to form and color cosmetics, including inorganic and organic dyes or pigments. ric materials approved by the Food and Drug Administration as "Indirect Food Additives" can be used as resins for use in the p compositions sing bioceramics. Non-limiting examples of polymeric als that can be used as resins for the make-up compositions include, c and modi?ed acrylic plastics; acrylonitrile/butadiene/styrene copolymers; acrylonitrile/butadiene/styrene/methyl methacrylate copolymers; acrylonitrile/styrene copolymers; acrylonitrile/styrene copolymers modi?ed with butadiene/styrene elastomer; cellophane; cyclohexylene dimethylene terephthalate and 1,4-cyclohexylene dimethylene isophthalate copolymers; ethylene—acrylic acid copolymers; ethylene-l,4-cyclohexylene dimethylene terephthalate copolymers; ethylene—ethyl acrylate copolymers; ionomeric resins; ethylene-methyl acrylate copolymer resins; ethylene—vinyl acetate copolymers; ethylene-vinyl _ 40 _ e-vinyl alcohol copolymers; ?uorocarbon resins; hydroxyethyl cellulose ?lm, water- insoluble; isobutylene polymers; isobutylenebutene copolymers; 4,4'- isopropylidenediphenolepichlorohydrin resins; melamine-formaldehyde resins; nitrile rubber modi?ed acrylonitrile-methyl acrylate mers; nylon resins; ole?n polymers; per?uorocarbon resins; polyarylate resins; polyarylsulfone resins; poly-l -butene resins and butene/ethylene copolymers; polycarbonate ; polyester elastomers; polyetherimide ; polyethylene resins, carboxyl modi?ed; polyethylene, chlorinated; polyethylene, ?uorinated; polyethylene, oxidized; polyethylene phthalate polymers; poly(p-methylstyrene) and rubber- modi?ed poly(p-methylstyrene); polystyrene and rubber-modi?ed polystyrene; polysul?de polymer-polyepoxy resins; polysulfone resins; poly (tetramethylene terephthalate); polyvinyl alcohol ?lms; polyurethane ; styrene block polymers; styrene-maleic ide copolymers; styrene-methyl methacrylate copolymers; textryls; urea-formaldehyde resins; vinyl chloride-ethylene mers; vinyl chloride-hexene-l copolymers; vinyl chloride-lauryl vinyl ether copolymers; vinyl chloride-propylene copolymers; Vinylidene chloride/methyl acrylate copolymers; dene chloride/methyl acrylate/methyl methacrylate polymers; ethylene polymers, chlorosulfonated; 4,4'-isopropylidenediphenol-epichlorohydrin thermosetting epoxy resins; l reinforced nylon resins; per?ourocarbon cured elastomers; phenolic resins; polyester resins, cross-linked; her resins, chlorinated; polyethersulfone resins; polyamide- imide ; poly(2,6-dimethyl-l ,4-phenylene) oxide resins; polyoxymethylene copolymers; polyoxymethylene lymers; polyphenylene sul?de resins; polyvinylidene ?uoride resins; and e-divinylbenzene resins, cross—linked.
Methods for the preparation of cosmetic compositions comprising the far infra-red emitting bioceramics described herein e formulating the compounds with one or more inert, pharmaceutically-acceptable excipients or carriers to form a solid, semi-solid, foam, wax, cream, lotion, or liquid composition. These compositions can also contain minor amounts of nontoxic, auxiliary substances, such as wetting or emulsifying agents, pH buffering agents, and other pharrnaceutically—acceptable additives.
A bioceramic may be added to an article of apparel in a variety of regular or irregular patterns. A bioceramic pattern may cover the entirety of the surface of an apparel or a pattern may cover a portion of an apparel. A bioceramic pattern ng an apparel may have s of discontinuity having a variety of shapes and sizes. For example, a pattern may be a honeycomb pattern (e.g., with hexagonal regions of discontinuity), a grid pattern (e.g., with _ 41 _ square-shaped or rectangular regions of discontinuity), a random pattern (e.g., with regions of discontinuity distributed randomly), and so forth. In general, the regions of discontinuity may be distributed across the surface at intervals that are regularly spaced or not regularly spaced. The regions of discontinuity may be formed with a variety of regular or irregular shapes such as, for example, circular, half-circular, diamond—shaped, hexagonal, multi-lobal, octagonal, oval, pentagonal, rectangular, square- shaped, star-shaped, trapezoidal, triangular, wedge-shaped, and so forth. If desired, one or more regions of discontinuity may be shaped as logos, letters, or s. In some embodiments, the regions of discontinuity may have sizes of about 0.1mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, or other d distance. In some embodiments, the s of discontinuity may range from 0.1 mm to about 1 mm, from 1 mm to about 5 mm, from 1 mm to about 10 mm, from 1 mm to about 15 mm, from 1 mm to about 20 mm, from 1 mm to about 25 mm, from 1 mm to about 30 mm, or other desired ce. In general, the regions of discontinuity may have the same or different shapes or sizes.
A bioceramic pattern may be applied as a coat covering an interior and/or an exterior surface of an article of l. A amic n may permeate a material, such as a fabric. A bioceramic pattern may cover various portions of a fabric in a continuous, discontinuous, regular, or irregular pattern, or any combination thereof. A bioceramic n may permeate less than 1%, less than 5%, less than 10%, less than 15%, less than 20%, less than %, less than 30%, less than 35%, less than 40%, less than 45%, less than 50%, less than 55%, less than 60%, less than 65%, less than 70%, less than 75%, less than 80%, less than 85%, less than 90%, less than 95%, or less than 99%, of an or surface of an article of apparel, an or surface of an article of apparel, or any combination thereof.
The following non-limiting es serves to further illustrate the present invention.
EXAMPLES EXAMPLE 1: Preparation of a bioceramic powder composition The kaolinite is extracted in the outskirts of the city of Parintins, in the Amazon State, Brazil. The city is located in the Lower Amazon Region (coordinates: latitude: 2° 37' 42" south / longitude: 56° 44' 11" west of Greenwich, 50 m above sea level). Alternatively, the kaolinite is obtained by purchasing it from a mining y/supplier.
The extracted kaolinite is washed with hydrogen peroxide (H202) and allowed to dry. The dried kaolinite is then ?nely ground and mixed with tourmaline; aluminum oxide (A1203); silicon dioxide (SiOz); and zirconium oxide (ZrOz) until a homogeneous mixture is achieved. The resulting bioceramic composition contains 50 wt % kaolinite, 10 wt % line, 18 wt % aluminum oxide, 14 wt % silicon e, and 8 wt % zirconium oxide.
A bioceramic composition was also synthesized. The resulting bioceramic contains any composition described herein, including about 50 % kaolinite, about 10 % tourmaline, about 18 % aluminum oxide, about 14 % silicon dioxide, and about 8 % zirconium oxide.
EXAMPLE 2: Application to clothing A bioceramic of the disclosure is a refractory, inorganic, polycrystalline ition that can be reduced to powdered format by grinding, crushing, or another suitable.
In powder form, a amic is incorporated into a range of materials; including various types of polymers and inks. A powered bioceramic is incorporated into a cloth substrate to ng an ink sing the bioceramic to the cloth.
A cloth substrate that includes 88 wt % polyamide and 12 wt % ne was obtained. A bioceramic composition ed according to the method of Example 1 was incorporated onto a plastisol ink in an amount of 10 — 50 wt % and mixed. The mixture was applied to the cloth substrate using a traditional silkscreen process. The speci?c type of ink was selected based on the chosen fabric.
EXAMPLE 3: Silkscreen a lication ofbioceramics to clothin e. . a shirt Concentration: ceramic materials are mixed with the ink at a 30% concentration of the total weight/volume.
Mixing process: ceramics were added to the ink gradually. Regular mixing process was d using a mixer that is customarily used for pigment and ink mixing. The materials are mixed until a consistent and uniform mix/slurry was ed. The s was fast as the ceramics mix well with all ent types of inks.
Durability of the slurry/mix: a well sealed mixture is stored and used up to one week after production.
Application: the bioceramic material was applied in the same manner as regular ink through a silk-screening process. It was observed that due to their particle size, the ceramic materials may h the screens. It is recommended that after every 1000 shirts the screens are checked/inspected and if needed they should be replaced, especially to avoid defects on the application and the look of the logo. _ 43 _ Fabric selection: the ceramics did not cause any observable damage to the fabric.
It was observed that fabrics that are too porous or cannot go through the regular drying process commonly used in silk-screening should be avoided.
Ink selection: the ceramics may increase ink density and the type of ink should be selected by a person of ordinary skill in the art based on the type of fabric used.
Drying process after silk-screening: due to the fact that the ceramics may contain a small amount of moisture, it was observed that the drying may take longer than usual.
The duration and intensity of the process depend upon the type of fabric and ink selected. After the ?rst experimental run with the fabric and ink selected, the product should be ted to a wash test to make sure the ink does not come off or crack.
A silk ing process is used to provide a c to an apparel with a desired pattern. A silk screen approach is used to intercalate an imprint with a pattern into a shirt.
FIGURE 1 illustrates a shirt comprising a c composition of the disclosure that was fabricated with a silkscreen ation.
EXAMPLE 4: Dot a lication a roach of a 1 in bioceramics to clothin e. . a shirt Concentration: ceramic materials are mixed with either silicone or a polymer, such as m-gel at a ratio of 1 part ceramic to 9 parts silicone. Alternatively, ceramic materials are mixed with a polymer, such as m-gel at a ratio of 1 part ceramic to 9 parts m-gel.
Application: a device has been used to apply the ceramic dots to the fabric with a desired pattern. A dot application approach is used to, for instance, intercalate a pattern into a shirt. FIGURE 1 illustrates a shirt comprising a ceramic composition of the sure.
Fabric ion: the ceramics do not cause any observable damage to the fabric.
A dot application approach is used to apply a amic to c areas of fabrics or apparel.
In some instances, a dot application approach is used to apply the ceramics to speci?c areas of the piece even on top of the silkcreen in order to e a higher concentration of ceramics per surface area. A dot application approach is used around the shoulders, elbows, or any area where it is desirable to apply a higher concentration of ceramics.
EXAMPLE 5: Binder/solution a roach of a l in amics to clothin e. . a shirt Concentration: as an alternative to mixing a ceramic to an ink and using a silkscreen or dot approach to apply the ceramic to a fabric, a binder solution approach is used. A binder solution ses up to 50 % c and up to 50 % binder solution or slurry.
] Application: a fabric is placed in a slurry solution comprising a ceramic and a binder at a d concentration. The fabric is removed from the slurry solution and d to dry. The fabric is now impregnated or infused with a ceramic of the disclosure. The fabric that is impregnated or infused with the ceramic is directly placed in contact with a skin of a subject.
EXAMPLE 6: Visible re eatin attema roach of a l in bioceramics to clothin e. . a shirt 1 Concentration: a ?rst solution comprising an ink is prepared. A second solution, slur, or binder comprising from about 10% ceramic to about 50 % ceramic is prepared by mixing a ceramic of the sure with the ink, slur, or binder.
Application: a ?rst pattern is sprayed, d, silk screened, or otherwise applied to a fabric. The ?rst pattern consists of ink and does not contain a bioceramic material. A second pattern comprising from about 10% ceramic to about 50 % ceramic is subsequently sprayed, printed silk screened, or otherwise applied to the surface of the ?rst pattern. Optionally, a silicone coating is applied over the second pattern to provide a glossy appearance of the pattern d to the fabric. Optionally, a silicone coating is mixed with a tration of the ceramics prior to being d as a coat.
EXAMPLE 7: Fabrication of a pad A thermoplastic elastomer (TPE) is lique?ed with a bioceramic of the disclosure.
The TPE and the ceramic are mixed at a concentration of about 1 part ceramic to 1 part TPE, 1 part ceramic to 2 parts TPE, 1 part ceramic to 3 parts TPE, 1 part ceramic to 4 parts TPE, 1 part c 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 ed mix is placed on a mold.
The mix of TPE and bioceramic is allowed to solidify to e an apparel with the shape of the mold. The apparel is removed from the mold. The apparel is a thermoplastic pad comprising a bioceramic, such as the pad illustrated in FIGURE 3.
EXAMPLE 8: Bioceramics as anti-in?ammatory agents and c?okine modulation Laboratory mice are administered injections of the bioceramic composition of Example 1. On the 5th day post CFA injection (after 5 consecutive Bioceramic treatments) the right hindpaw of the mice is collected and used to estimate the cytokine levels by enzyme-linked immunosorbent assay (ELISA), with sample values corrected by protein levels. Optionally, the following cytokines are evaluated, individually or as a group: TNF-(x, lL-lB, lL-lO and lL—6. _ 45 _ The absorbance for the aforementioned cytokines could be measured using a microplate reader at 450 and 550 nm. ne levels of mice could be determined to con?rm the anti-in?ammatory effect of the amic compositions.
EXAMPLE 9: Determination of oxidative stress and anti-oxidative enzme levels Laboratory mice are administered injections of the amic composition of Example 1.
On the 5th day post CFA injection right hindpaw tissues (skin and muscles) of the mice can be collected and used to assess oxidative damage. For this test the formation of thiobarbituric acid reactive species (TBARS) is measured during an acid-heating reaction. The s are mixed With 1 mL of oroacetic acid (TCA) 10% and 1 mL of thiobarbituric acid 0.67% and then heated in a boiling water bath for 15 min. TBARS levels are determined by the absorbance at 535 nm. Results are expressed as malondialdehyde (MDA) equivalents (nmol/mg Oxidative damage to proteins are measured by the quanti?cation of carbonyl groups based on the reaction with dinitrophenylhydrazine (DNPH), as previously described.
Proteins are precipitated by the addition of20% trichloroacetic acid and are optionally redissolved in DNPH; the absorbance is read at 370 nm. Results can be reported as nmol of carbonyl content per mg of protein (nmol/mg protein) or results can be reported using another suitable unit.
To determine catalase (CAT) activity, the paw tissues are sonicated in 50 mmoL/L phosphate buffer (pH 7.0), and the resulting suspension is ?iged at 3000 x g for 10 min.
The supernatant is used for enzyme assay. CAT activity is measured by the rate of decrease in hydrogen peroxide ance at 240 nm. Results can be reported as (U/mg protein) or any other suitable unit.
Superoxide dimuthase (SOD) activity is assayed by measuring the inhibition of adrenaline auto-oxidation, as usly bed. All biochemical measures are normalized to the protein content, with bovine albumin as standard. All the results are ized by protein concentration measured by the Lowry assay. Results are reported as (U/mg protein) or any other suitable unit.
EXAMPLE 10: Effect of far infrared emitted by bioceramics on parameters of physical performance in mice Objective: To evaluate the effect of Far Infrared therapy emitted by amics on ters of physical performance in mice subjected to a swimming protocol.
Methods: Experiments were conducted with male Swiss mice (30-35g) after approval of the University of South of Santa Catarina Ethics Committee. The mice were randomly divided into 2 groups and subjected to a 30 min 21 day swimming protocol. For treatment, a bioceramics pad containing the composition described in e 1 (80% n PVC - 20% Bioceramic materials) was placed inside the animals box for three weeks. Control animals were placed on a sham pad (100% n PVC without bioceramics) and underwent the same experimental protocol. At the end of each week body weight and food and water intake were measured and an exhaustion test was conducted in which the mice were put to swim until exhaustion with a charge of 5% ofbody weight tied to their tail. Point of Exhaustion was determined when the animal could not maintain its head out of the water surface for more than 5 s. At the end of third week right hind limb grasping strength was conducted using a strain gauge force feedback system and the gastrocnemius muscle weight was assessed with an analytical scale.
Results: Far infrared d by a bioceramic pad containing the composition of Example 1 increased time to reach exhaustion in forced swimming test (133.1%, 60.4% and 90.83% in weeks 1 to 3) but did not affect body weight, water or food consumption. Although gastrocnemius muscle weight was not affected, the bioceramic of Example 1 increased hindlimb grasping strength in 6.6%.
Conclusion: Far Infrared therapy emitted by a bioceramic of Example 1 increased hindlimb grasping strength and time to reach exhaustion of mice ted to a three week swimming protocol. These results indicate increased resistance, muscle endurance, and overall stamina (energy levels).
EXAMPLE 11: Far infrared therapy emitted by bioceramics improves postural sway in human athletes Objective: The objective of the present study was to te the effect of far ed therapy emitted by bioceramics on the orthostatic balance ofjudo practitioners as) of a Brazilian university team in a double blind controlled trial.
Methods: A total of 17 athletes (7 women and 10 men; 23 i 4.75 of age) of the University of South of Santa Catarina L) wore either a bioceramics shirt containing the _ 47 _ composition of Example 1 shirt (bioceramics silkscreened shirt) or a sham shirt (without bioceramics) during practice (for two hours, ?ve times a week for a period of ?ve months). The Judokas were of seven ent weight ries and were evenly divided in the two experimental groups (bioceramic or sham shirt) in such a way that each group had approximately the same amount of athletes of each weight category. Center of pressure (CoP) parameters (length, sway area, velocity in anteroposterior and mediolateral direction) were measured in three sec duration static bipedal standing tasks - the athletes were asked to maintain their eyes opened and stand in a narrow stance on a Balance Platform (T-Plate Balance Platform , Medicapteurs, France). Evaluations were conducted before and after 5 months of use of the amic shirts.
Results: The results obtained demonstrated statistically signi?cant ses (p<0.05) in all CoP parameters evaluated (length, sway area, velocity in anteroposterior and mediolateral direction) in bioceramics shirt group athletes when compared with sham shirt group.
Conclusion: Far Infrared therapy emitted by a amics shirt containing the composition of Example 1 positively affected the orthostatic balance of Judo practitioners of a Brazilian university team.
EXAMPLE 12: Far infrared emitted by bioceramics reduces mechanical and thermal hyperalgesia in an animal model of chronic in?ammatory pain Objective: This study evaluated the effect of far infrared emitted by the bioceramic composition of Example 1 incorporated into a pad t mechanical and thermal hyperalgesia as well as paw temperature increase and edema formation in a mice model of in?ammatory pain.
Methods: Experiments were ted with male Swiss mice (30-35 g) after al of the University of South of Santa Catarina Ethics Committee. The animals underwent intraplantar injection of Freud’s te adjuvant (CFA, 20 ul - 70%) and for treatment the bioceramics pad (80% BioCorn PVC - 20% Bioceramic als) was placed inside the animals box. After 24 h of exposure to the product, mechanical and thermal hyperalgesia was assessed as se frequency to 10 presentations of a 0.4g von frey ?lament or by hot stimuli applied to the animals right hind paw (Hot Plate Method). Evaluations were performed daily for 10 days.
After evaluation the animals were placed in their boxes and re-exposed to the Pad until the subsequent evaluation (24 hours later). In addition, edema formation and hind paw temperature were evaluated on mental days 1, 3 and 10 with a eter and a l thermometer, respectively. Control animals were placed on a sham pad (100% BioCom PVC t bioceramics) and underwent the same experimental protocol.
Results: Acute exposure to the bioceramics pad induced analgesia which lasted for 2 hours (P<0.001 - maximum inhibition of 53 i 11%). Chronic treatment d mechanical hyperalgesia on all evaluation days and thermal hyperalgesia on days 1 and 3. In addition, the treatment decreased paw temperature on days 1 and 3 day, 8i1% (P <0.001) and 5i1% (P <0.05) but did not affect edema formation.
Conclusion: Far infrared emitted by the bioceamics pad reduced mechanical and thermal hyperalgesia of in?ammatory origin as well as paw temperature increase induced by intraplantar injection of CFA in mice.
EXAMPLE 13: A randomized double bind placebo—controlled trial with a sity Division I soccer team to assess physical ?tness parameters Objective: To evaluate the effect of amic imprinted practice uniforms on: respiratory capacity, back and leg muscle strength and cardiorespiratory ?tness.
: A randomized double bind placebo-controlled trial involving 30 healthy Soccer Players. Each participant was randomized via manual draw to wear either a practice uniform comprising a bioceramic ition of Example 1 or a sham ce uniforms during r practice sessions as well as a bioceramic or sham band throughout the day. Evaluations were conducted with both groups once a week for 4 utive weeks on pre-determined days before the beginning of the days practice.
Testing Methodology and Results (a) Respiratory ty Respiratory capacity was evaluated with a spirometer (Model SP-10). The parameters evaluated were Forced Vital Capacity (FVC), Forced Expired Volume in one second (FEV1) and Peak expiratory ?ow (PEF). Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters. FVC is the most basic maneuver in spirometry tests.
FEVl is the volume of air that can forcibly be blown out in one second, after full ation.
Peak expiratory ?ow (PEF) is the maximal ?ow (or speed) ed during the maximally forced expiration initiated at full inspiration, measured in liters per minute. (b) Back and leg muscle strength Back/leg dynamometer (Baseline, United States) was used to measure leg and back muscle strength. Using a pronated grip the participant held the device's handle bar and slowly straightened his legs up to their maximal level. (c) Cardiorespiratory ?tness Cardiorespiratory ?tness was evaluated h the standardized 3-minute se test (pre- determined in ction with the Team's coach). The cardiorespiratory nce index is derived from heart rate recovery after the test with the following formula: cardiorespiratory endurance index=duration of exercise (seconds)x100/sum of heart beats during the recovery period/2. The sum of heart beats during the recovery period is the sum of the heart rates during 3 periods after the test: 1 to 1.5 minutes, 2 to 2.5 minutes, and 3 to 3.5 minutes.
Conclusion: Results indicate that in all different parameters analyzed the athletes wearing bioceramics technology presented better overall s in comparison to the athletes that were g placebo gear.
EXAMPLE 14: Effect of far infrared emitted by bioceramics on clinical measures of physical ?tness Objective: To evaluate the effect of Far Infrared therapy emitted by bioceramics on ?exibility, grip strength and respiratory capacity in a randomized double blind placebo controlled trial involving 9-l2 Basketball Players of the Florida Atlantic University (ages 18-22). s: Each participant was randomized to wear either a bioceramics shirt (bioceramics silkscreened shirt) ning bioceramic of Example 1 or a sham shirt (without bioceramics). Baseline evaluations were conducted on week 1. The players wore the jerseys three times a week during practice hours - from 9am to 12pm. Evaluations were ted with both groups once a week for 3 consecutive weeks on Wednesdays during the ?rst hour of the day’s practice. In the second round of tests the groups were swapped. The group that was wearing the Sham BioPower Practice Uniforms was selected to wear BioPower shirts 7 days a week (throughout the day) and the group that was previously wearing BioPower uniforms stopped wearing the technology and served as control. Evaluations were conducted with both groups once a week for 3 consecutive weeks on days during the ?rst hour of the day’s Flexibility was measured with the sit—and—reach test (Novel ester® Sit & Reach Box). For evaluation each subject was asked to sit on the ?oor with knees ?at against the ?oor and the box ?at against the r aspect of his feet. Then the subject stretched out and reached towards the box and moved to distance indicator as far as le. The mean of three measurements was used in the analysis.
] The grip strength of the dominant hand was measured with a hand dynamometer a Baseline Smedley Digital Spring Hand Dynamometer with the subjects standing with their elbows extended. The mean score ofthree trials was recorded for analysis.
Respiratory capacity was evaluated with a spirometer (Model SP-lO). The ters ted were Forced Vital Capacity (FVC), Forced Expired Volume in one second (FEVl) and Peak expiratory ?ow (PEF). The best of three measurements was used in the analysis. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters. Forced Expired Volume in one second (FEV 1) is the volume of air that can ly be blown out in one second, after full inspiration. Peak expiratory ?ow (PEF) is the maximal ?ow (or speed) achieved during the maximally forced expiration initiated at full inspiration, ed in liters per minute.
Results: Flexibility.
FIGURE 3 is a graph illustrating a non—limiting example of effects of bioceramics of the instant disclosure on ?exibility. In the ?rst round of tests the use of a bioceramic did not affect Flexibility in comparison to baseline levels (FIGURE 3, Panel A). In the second round of tests, in comparison to baseline levels, the use of the bioceramic technology increased Flexibility in 5.5% and 14.1% in the ?rst and second week of continuous use, respectively. Flexibility was not affected in the group of athletes not wearing the technology (FIGURE 3, Panel B). Grip Strength. In the ?rst round of tests the use of the bioceramic sed Grip Strength in 5.6% on the second week of continuous use in relation to baseline levels. l group Grip Strength was not altered from one tion to the other (FIGURE 3, Panel C). In the second round of tests, in comparison to baseline levels, the use of the bioceramic technology increased Grip Strength in 10.8% and 10.9% in the ?rst and second week of continuos use, respectively E 3, Panel D). On the other hand, in the group that consisted of athletes who were wearing the technology for 2 weeks (in the ?rst round of tests) and discontinued its use, there was a decrease in Grip th of 7.23% and 13.51% in the ?rst and second week of evaluations respectively (FIGURE 3, Panel D).
Respiratory Capacity. S 4 and 5 are graphs illustrating a non-limiting example of effects of bioceramics of the t disclosure on respiratory capacity. FIGURE 4 illustrates a non-limiting e of the effect of a bioceramic of the instant disclosure on forced vital capacity (FVC) and forced expired volume in 1 second (FEVl). FIGURE 4 illustrates a non-limiting example of the effect of a bioceramic of the instant disclosure on peak expiratory _ 51 _ ?ow (PEF). In the ?rst round of tests the use of the bioceramic increased FVC (5.8% - FIGURE 4, Panel A) and FEVl (5.9% - FIGURE 3, Panel C) but did not affect PEF E 5, Panel A) in comparison to baseline levels. Control group FVC, FEVl and PEF decreased from one evaluation to the other E 4, Panels A and C, and FIGURE 5, Panel A).
In the second round of tests, in ison to baseline levels, the use of the bioceramic technology increased FVC (5.8% in the second week - FIGURE 4, Panel B); FEVl (15% and % in week one and two respectively - FIGURE 4, Panel D) as well as PEF (52.77% and 50.9% in week one and two respectively - FIGURE 5, Panel B). In the group that consisted of athletes who were wearing the logy for 2 weeks (in the ?rst round of tests) and tinued its use, PVC and FEVI oscillated from one evaluation to the other (FIGURE 4, Panels B and D, respectively), while PEF, on the other hand, decreased 19.7% in the ?rst and 23.3% in second week of tions (FIGURE 5, Panel B).
Conclusion: Far Infrared therapy emitted by bioceramics shirts increased ?exibility, grip strength and respiratory capacity in healthy basketball players of the Florida Atlantic University. Continuous prolonged use induced the most signi?cant results.
EXAMPLE 15: Effect of bioceramics imprinted l on muscle endurance and cardiorespiratory ?tness in es Objective: To evaluate the effect of amics imprinted practice apparel (shirts and shorts) on muscle endurance and cardiorespiratory ?tness.
Testing Methodology and Results: Each participant wore a bioceramics shirt/short during ce (3 times a week - 120 minute training session). In additional the participants wore a bioceramics shirt for 6-8 hours a day, 7 days a week. Evaluations were conducted once a week on Mondays. (a) Muscle Endurance Muscle endurance was measured with the p test. The subjects were asked to (1) lie prone on ?oor with hands slightly wider than shoulder width then (2) raise body up off ?oor by extend arms with body straight. The maximum number of sit-ups performed until exhaustion was used to represent muscle endurance.
FIGURE 6 illustrates the effect of bioceramics on muscle endurance of humans.
Data depicted in FIGURE 6 demonstrate that there has been a gradual increment in the maximum number of push-ups performed by the athletes. Best ent in comparison to evaluation conducted without the use of bioceramics was obtained in week n#4 (13.95%).
FIGURE 6 illustrates the results of an experiment where N = 5. Numbers above bar indicate se in comparison to "No BioPower" week control. (b) Cardiorespiratory Fitness Cardiorespiratory ?tness was evaluated through a standardized test with minor variations. The cardiorespiratory nce index is derived from heart rate recovery after the test with the following formula: cardiorespiratory endurance index=duration of exercise ds)x100/sum of heart beats during the recovery period/2. The sum of heart beats during the recovery period was the sum of the heart rates during 3 periods after the test: 1 to 1.5 minutes, 2 to 2.5 minutes, and 3 to 3.5 minutes.2 Two evaluations were conducted: the ?rst after a 10-minute warm-up session and the second after the te p test described in item 3.2. The standardized 3- minute time was used in the calculations in order to normalize the results of both tests to facilitate comparisons.
FIGURE 7 illustrates the effect of bioceramics on cardiorespiratory ?tness of humans. FIGURE 7 illustrates the results of an experiment where N = 5. FIGURE 7, panel A illustrates the s of an evaluation conducted after warm-up n. FIGURE 7, panel B illustrates the results of an evaluation conducted after push-up session. Numbers above bar indicate se in comparison to "No BioPower" week l.
Results presented in FIGURE 7 indicate that the use of bioceramics increased cardiorespiratory index in all evaluations conducted both after warm-up (FIGURE 7, panel A) and push-up sessions (FIGURE 7, panel B). Maximum increment in comparison to evaluation conducted without the use of bioceramics ed on week n#3 (6.10% and 7.69%).
Conclusion: Results indicate that the use of bioceramics imprinted l helped increase muscle endurance and cardiorespiratory ?tness of 5 MMA ?ghters.
EXAMPLE 16: Effect of bioceramics paint on CFA induced mechanical hypersensitivity Objective: The use of bioceramic paint containing the composition of Example 1 on CFA induced mechanical hypersensitivity was evaluated.
Methods: Experiments were conducted using adult male Swiss mice weighing -35 g, housed at 22°C under a 12-h light/12-h dark cycle (lights on at , with access to food and water ad libitum. The experiments were performed after approval of the protocol by the Ethics Committee of the Universidade do Sul de Santa Catarina L). The animals (n = 8) underwent intraplantar injection (right hind paw) of a solution containing 20 ul of Freud's complete nt (CFA, 70%). For treatment a bioceramics paint (10 and 20% concentration) was applied to the bottom of the animals’ box. After 24 h of exposure mechanical nociceptive _ 53 _ old was assessed as response frequency to 10 tations of a 0.4g von frey ?lament applied to the animals right hind paw. tions were also conducted on days 2 and 3 post CFA injection.
Results: The results show that the i.pl. injection of CFA induced mechanical ciception (P <0.001) which was signi?cantly reduced by exposure to the bioceramic paint (20 but not 10% bioceramic concentration) applied to the bottom of the animals’ box.
Effect lasted for up to 4 hours (day 2 and 3). FIGURE 8 rates the effects of bioceramic paint on CFA induced mechanical hypersensitivity. Evaluation of 8 individuals, the vertical lines indicate the S.E.M. * p<0.05. FIGURE 9 illustrates a bioceramic paint.
Conclusion: Bioceramic paint reduced ical hypersensitivity induced by CFA paw injection.
EXAMPLE 17: Far infrared emitted by c materials increases p_aw temperature and reduces ical hypersensitivity and knee edema in a rat model of monoiodoacetate-induced osteoarthritis Objective: This study investigated the effect of far infrared emitted by ceramic materials on skin ature, paw mechanical hypersensitivity and knee edema in a rat model of monoiodoacetate (MIA)—induced osteoarthritis.
Methods: Experiments were conducted with male Winsar rats (200-250 g) anesthetized with a mixture of ketamine and xylazine (50 and 10 mg/kg, respectively, i.p.). Joint damage was induced by a single intra-articular ion of MIA (1 mg/SO ul; Sigma UK - which disrupts glycolysis resulting in ocyte death) through the infrapatellar nt of the right knee. Control animals ed a single injection of saline (50 ul). Three separate measures were assessed: (1) thermal analyses of the central areas of the front paws of the animals (with a portable ThermaCAM® E320 ed camera - Flir, Sweden - with a 320 x 240 pixels resolution, thermal sensitivity of<0. 10°C at 25°C and accuracy of i 2°C - positioned 0.5 m away from the animals paws. The infrared images were analyzed with the FLIR QuickReport 1.2 software); (2) hind paw mechanical withdrawal thresholds (using von Frey mono?laments - Semmes-Weinstein monofilaments of bending forces 1-15 g), which provide an index of central sensitisation; and (3) edema formation (measured with a digital caliper - Pantec, Brazil), which is directly associated with the localized in?ammatory response. For treatment a bioceramics pad ning the bioceramic of Example 1 (80% BioCorn PVC - 20% ceramic materials) was placed inside the animals box; control animals were placed on a Sham Pad (100% BioCorn PVC without ceramics) and underwent the same experimental protocol. _ 54 _ Results: On day 3 post-MIA injection acute exposure (2 hours) to the bioceramics pad increased paw temperature (i 4°C), gh only chronic exposure to the treatment (Day 7 and 10 post-MIA) reduced mechanical hypersensitivity (p<0.001) and knee edema 01).
Conclusion: Far infrared emitted by ceramic materials increased paw temperature (after acute re) whereas only prolonged treatment reduced mechanical hypersensitivity and knee edema in a rat model of MIA-induced osteoarthritis.
EXAMPLE 18: Far infrared emitted by bioceramics reduced hypemociception of in?ammatom origin in mice Objective: The aim of this study was to evaluate the effect of far infrared radiation emitted / re?ected by bioceramics in a pad containing the bioceramic of Example 1 on pain of in?ammatory origin as well as on paw temperature increase and edema formation in an experimental model of in?ammation in mice.
Methods: ments were ted using adult male Swiss mice weighing -35 g, housed at 22°C under a 12-h light/12—h dark cycle (lights on at 06:00), with access to food and water ad libitum. The ments were performed after approval of the protocol by the Ethics Committee of the Universidade do Sul de Santa Catarina L). The animals (n = 8) ent intraplantar ion (right hind paw) of a solution containing 20 ul of Freud's complete adjuvant (CFA, 70%). For treatment a bioceramics pad was placed inside the animals box. After 24 h of exposure to the product, ical nociceptive threshold was assessed as se frequency to 10 presentations of a 0.4g von frey ?lament applied to the s right hind paw. The evaluations were performed daily for 10 days - after each evaluation, the animals were put back in their boxes and re-exposed to the Pad until the subsequent evaluation (24 hours). In addition, the volume (edema formation) and the temperature of the right hind paws were evaluated on mental days 1, 3 and 10 with a Pleithsmometer and a digital thermometer respectively. Control animals were placed on a sham pad - consisting of 100% BioCom PVC (without bioceramics) and underwent the same experimental protocol.
Results: The results show that the i.pl. injection of CFA induced mechanical ciception (P <0.001) which was signi?cantly reduced by acute re to the bioceramics pad containing bioceramic of Exanple 1. The analgesia lasted for up to 2 hours with peak effect 30 min after treatment (P <0.001 — maximum inhibition of 53 i 11%). Chronic treatment with the bioceramic pad reduced mechanical hypemociception on all evaluation days.
In addition, the treatment signi?cantly decreased paw temperature on days 1 and 3 day, 8::l% (P <0.001) and 5::l% (P <0.05) respectively, when compared with the l group.
] Conclusion: The bioceramics pad reduced mechanical hypemociception of in?ammatory origin as well as the increase ofpaw temperature induced by intraplantar injection of CFA in mice.
EXAMPLE 19: Uses of bioceramics emitting far infrared energy in the treatment of human conditions A bioceramic emitting far infrared energy is used to modulate or treat one or more of the following: pain, muscle endurance, stamina, muscle strength, respiratory ?tness, respiratory capacity, ?exibility, cellular lism, analgesia, cellular oxidation , ?bromyalgia, in?ammation, oxidative stress, blood circulation, intolerance to cold environments, arthritis or vascular disease, cutaneous perfusion, arrhythmia, high blood pressure, tissue , an esthetic effect such as a reduction in cellulite of the subject, an improvement in the y of life.
Methods: a subject wears an apparel of the disclosure comprising a bioceramic for at least 6 weeks. The following parameters or endpoints, alone or in combination, are used to measure the effects of articles of clothing impregnated with an infrared emitting ceramic material(s) in the treatment of human subjects with a condition disclosed herein: a) quality of life, sleep patterns, depression and anxiety; b) pain, muscle strength, and ?exibility; c) balance and distribuition of the standing pressure; d) stress (measured by activity of the autonomous, sympathetic, and parasympathetic nervous systems; e) body surface temperature; f) tory mediators (anti- and pro-in?amatory cytokines); or g) oxidative stress and antioxidant systems. amic treatments: t-shirts or pads impregnated with an infrared emitting bioceramic material of the BioPower® brand or control T-shirts are buted between groups.
Patients are instructed to wear the apparel comprising the ceramic materials during the day, at night, or during their sleep. Treatment is conducted for about three utive .
FIGURE 10 rates a human subject wearing exemplary t-shirts or pads comprising a ceramic of the sure. nts: some ofthe following endpoints, alone or in combination, are used to quantify an efficacy of a amic material in a subject: a) evaluation of grip strength; b) _ 56 _ ?exibility evaluation; 0) thermography; d) tion of pro-in?ammatory and anti-in?ammatory cytokines; e) evaluation of antioxidants, tion ofmarkers of oxidative stress, or f) questionnaires.
Evaluation of grip strength: a dynamometer is used as an instrument for the assessment of grip strength. The principle of operation of the dynamometer relies in the deformation undergone by a spring due to the action of a force. The intensity of the force is graded, so the dynamometer is a useful method for the measurement of force of some subjects.
The dynamometer is particularly useful to measure the intensity of force in, for instance, human subjects af?icted with ?bromyalgia, since the dynamometer ements take into account the common and predominant muscle fatigue in the upper limbs (UL) and in the icular skeleton as compared to the axial upper limb studies.
Flexibility Evaluation: ?exibility tion is ed with the Third Finger- Soil test. The instrument measures the overall ?exibility of a subject with regards to subject standing ?exibility, the ability of a subject to hold their feet er, and the maximum ?exibility of the trunk of a subject without ?exing their knees. This measurement is conducted on subjects with relaxed heads and the distance between the ground and the third toe is measured with a tape measure, on either the right or left side. A subject that is e of touching the ground is considered a subject with good ?exibility.
Thermography Evaluation: thermography is a useful technique in the analysis of hyper-radiating points in the infrared image, as it allows for the detection of thermography images in the surface skin of a t, such as the skin of the human body. The technique is optionally performed on a human subject that is standing up and undressed, with the arms ed alongside the body but not touching the body. The temperature is maintained at about 0C throughout the ure. Prior to capturing the image, the subjects are asked to rest for minutes to allow for the body temperature to become acclimated to the lled room temperature.
Evaluation of Proin?ammatory and Anti-In?ammatory Cytokines: Blood samples are collected and prepared for analysis by centrifugation , IL-6, IL-lB e TNF-u).
The serum is processed for cytokine analysis. The serum may optionally be kept frozen at 80 0C for up to one year. The serum is analyzed by immunoassay (pg/dL) (Sandwich ELISA) using commercial kits and the concentration of cytokines is determined. One of skill in the art will appreciate that other methods known in the art can optionally be used to evaluate levels of proin?ammatory and anti-in?ammatory cytokines.
Evaluation of idants and Determination of Oxidative Stress: _ 57 _ a) substances reactive to thiobarbituric BARS: to ine the effects of bioceramics on the modulation of oxidative stress a sample comprising serum lipids is collected from a subject. The sample is analyzed by heating it in an acid reaction by TBARS. (Esterbauer, H., Cheeseman, K.H. ination of aldehydic lipid peroxidation products: malonaldehyde and 4-hydroxynonenal. s Enzymol, V. 186, p. 407-421, 1990). Brie?y, serum is mixed with 1 mL of 10% trichloroacetic acid and 1 mL of 0.67% rbituric acid and is subsequently placed in a g water bath for 15 min. Absorbance at 535 nm is measured using 1,1,3,3- tetramethoxypropane as external standard. The results are calculated and ted as malondialdehyde equivalents per milligram of protein. One of skill in the art will appreciate that other methods known in the art can optionally be used to evaluate levels of oxidative stress in a sample. b) protein carbonylation: the effect of oxidative stress on proteins is 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, 1.; Lenz, A.G.; Ahn, B.W.; Shaltiel, S.; Stadman, E.R. Determination of carbonyl content in oxidatively modified proteins. Methods Enzymol, v. 186, p. 464-478, 1990; incorporated by reference herein). Brie?y, the proteins are first itated with the addition of 20% trichloroacetic acid and dissolved in dinitrophenylhydrazine, and then the absorbance is measured at 370 nm. The results are expressed as levels of protein carbonyls by milligram of protein. One of skill in the art will appreciate that other s known in the art can optionally be used to evaluate levels of protein carbonylation. c) extent of oxidative damage in the sulfyhydryl group of proteins: oxidative damage of proteins is analyzed by characterizing damage to the dryl 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. NeurosciLett, v. 302, p. 141-145, 2001). Brie?y, the proteins in the sample are precipitated and dissolved in dithionitrobenzoic acid. Absorbance is measured at 412 nm. The results are sed as levels of TNB per milligram protein. One of skill in the art will appreciate that other methods known in the art can be used to evaluate levels of oxidative damage in the sulfyhydryl group of proteins. d) idant ty of enzymes: the activity of se (CAT) is determined by measuring the decrease in the absorbance of hydrogen peroxide at 240 nm. The data is plotted as units per ram of protein. The activity of superoxide dismutase (SOD) is determined by the inhibition of auto-oxidation of adrenaline ed spectrophotometrically at 480 nm (described _ 58 _ by Bannister, J.V.; Calabrese, L. Assays for superoxide dismutase. Methods Biochem Anal, V. 32, p. 279—312, 1987) and expressed as activity units per milligram of protein. One of skill in the art will appreciate that other methods known in the art can be used to evaluate enzyme activity levels. e) determination of total protein: all biochemical ements can be ized by protein content with bovine serum albumin as standard with for example, the methods describe by Lowry, Rosebrough, and Farr (Lowry, O.H.; ough, N.J.; Farr, A. Protein measurement with the Folin phenol reagent] BiolChem, v. 193, p. 265-275, 1951).
The t bene?ts from at least one of the following by using an l of the disclosure: a reduction in pain, an increase in muscle endurance, an increase in stamina, an se in muscle strength, a modulation of the cardiorespiratory system, such as an increase in respiratory capacity, an increase in ?exibility, a modulation of cellular metabolism, an improvement of analgesia, an anti—oxidative effect, an anti—fibromyalgia effect, a decrease in in?ammation, a decrease in oxidative stress, a modulation of cytokine levels, a modulation of blood circulation, a reduction in intolerance to a cold environment, a reduction in a symptom of tis or vascular disease, an increase in cutaneous perfusion, a decrease in heart rate, a decrease in blood pressure, quicker recovery from injury or exercise, an esthetic effect such as a reduction in cellulite of the subject, an improvement in the quality of life.
EXAMPLE 20: Uses of bioceramics emitting far infrared energy in the treatment of human fibromyalgia Fibromyalgia is a pain?Jl chronic condition, usually anied by diverse symptoms and preponderantly affecting the musculoskeletal system. 2.5% of the Brazilian population is af?icted with Fibromyalgia. According to recent iological data, imately 2% of the world population is affected by Fibromyalgia. The principal symptoms of fibromyalgia are associated with persistent pain lasting longer than three months, disruptions in sleep, e, anxiety, hesia, hes, and tender points. There is an ongoing debate ing the underlying causes of fibromyalgia, however studies have raised the possibility that yalgia is d to genetic causes, trauma, infections, stress.
Objective: this study evaluates the effects articles of clothing impregnated with an infrared emitting ceramic al(s) (bioceramic) as compared to aquatic exercises in the ms and prognosis of patients diagnosed with ?bromyalgia.
Study Design: the present research is based in a blind randomized clinical study.
It is designed to adequately compare the ef?ciency of distinct treatments; patients are randomly _ 59 _ distributed within groups to avoid systematic errors. Individuals are randomized as follows (11 = per group): Group 1: control group, is not treated with hydrokinesiotherapy or bioceramic; Group 2: is treated with bioceramic materials only; Group 3: is treated with hydrokinesiotherapy only; Group 4: is treated with both hydrokinesiotherapy and bioceramic. inesiotherapy Treatment: exercises previously described by Berti et al (2008) (BERTI, Gabriela et al. Hidroterapia Aplicada ao tratamento de Fibromialgia: avaliacao clinica e laboratoriais de pacientes atendidos no Centro Universitario e em Nova go — RS. a digital de Educacion Fisica y Desportes. n. 122, 2008; incorporated herein by reference) are conducted, for instance, in the temperature controlled ng pool of the UNISUL Aquatic x. Alternatively, exercises can be conducted in any suitable pool.
Exercises are ted in four phases encompassing 36 sessions of 1 hour each, three times a week per group. During the ?rst phase there can be a global warm-up following a straight line along the extension of the pool, moving forwards and laterally. The second phase can last approximately 15 minutes and can include active stretching of superior and inferior muscles, sustained for consecutive 20 second intervals. The on of the exercises in the third phase is about 20 minutes, and the exercises are designed to be vely free of activity in superior and inferior body s. Finally, the fourth phase can consist of relaxing exercises characterized by oscillatory movements, conducted under the supervision the physiotherapist.
Conclusion: one or more ofthe nts /parameters described in Example 19 are used to determine an y of a bioceramics emitting far infrared energy in the treatment of human ?bromyalgia. The hypothesis is that a c of the disclosure is effective in the treatment of humans with ?bromyalgia.
EXAMPLE 21: Randomizedl placebo-controlled trial to test the ef?cacy of a bioceramic as an adjuvant to physical therapy in the treatment of chronic low back pain in humans Low back pain (LBP) is a common complaint in today’s society and is a signi?cant cause of discomfort in adults younger than 45 years old. tating back pain that ues for more than 3 months is considered chronic. Chronic low back pain (CLBP) has many causes, which are treated with diverse methods, such as bed rest, lumbar support devices, traction, thermotherapy, electrical stimulation, and manipulation in most cases. Invasive treatment methods, such as surgery, selective nerve root block and epidural injection, can be used to treat chronic back pain.
Objective: the aim of this study is to evaluate the effect of an apparel of the disclosure comprising a bioceramic that emits far infrared energy re?ecting bioceramics to treat chronic back pain.
] Methods: the study is designed as a controlled clinic trial to test the ef?cacy of a far-infrared emitting c sleeve or patch as an nt to physical therapy treatment of chronic low back pain.
] Intervention: subjects will follow a regular physical therapy (PT) regimen treatment at the Wilfred R. Cameron Wellness Center clinic in Washington, PA. Subjects will be randomly divided into 3 (three) experimental groups: a) control: receives PT treatment only. b) bioceramic patch: receives PT treatment and uses a amic patch for "11" hours after the treatment. c) placebo: receives PT treatment and uses a placebo patch (without bioceramics) for "11" hours after the treatment hours after the treatment.
Evaluation of pain and lity level: The Oswestry Back Pain Disability Index (ODI); the -Morris Low Back Pain and Disability Questionnaire and the che Index" (BAI) will be used to evaluate pain levels. The hypothesis is that a patch of the disclosure will be effective in the treatment of humans with chronic back pain.
E 22: Uses of bioceramics emitting far infrared energy in the treatment of human p_ain A subject with chronic back pain wears a pad of the disclosure. The ef?cacy of the pad has been evaluated in a study described in Example 21 or another suitable study. An exemplary pad for the treatment of chronic back pain is the pad shown in FIGURE 2 worn as shown in FIGURE 10, either vertically or horizontally.
Intervention: the subject with chronic back pain wears the pad daily for about 6 consecutive weeks for 7 consecutive days. The pad provides an amount of ed energy to the subject. The amount of infrared energy received by the t is as follows (far infrared wavelength between 9 and 10 micrometers): * Fabric silkscreened with ink at a 50% bioceramic tration: irradiance of 4.05 milliW/cm2 at a body temperature of 36.5 0C provides about 2.43 J/cm2 per hour of use.
* Fabric silkscreened with ink at a 30% bioceramic concentration: irradiance of 3.65 milliW/cm2 at a body temperature of 36.5 0C provides about 2.19 J/cm2 per hour of use.
The ent provides relief to the subject with chronic back pain.
The subject wants to prolong the relief from chronic back pain. The subject optionally consults his physician or physical therapist to discuss treatment regimens and options.
The subject adjusts the treatment regimen to prolong the feeling of relief by wearing the patch for longer s of time. The subject experiences prolonged relief to c back pain.
EXAMPLE 23: Uses of bioceramics emitting far infrared energy in the treatment of human carpal tunnel sEdrome Carpal tunnel syndrome (CTS) is an ment neuropathy, which is caused mainly by median nerve compression and irritation at the level of carpal tunnel. Its symptoms include pain and paraesthesia in the wrist and hand that can radiate to the forearm. CTS affects 1% to 3% of population, with higher incidence in certain occupational groups who perform repetitive motions of the hand and wrist.
Objective: the aim of this study is to evaluate the effect of an apparel of the disclosure comprising a bioceramic that emits far infrared energy re?ecting amics to treat carpal tunnel syndrome.
Methods: ized, placebo—controlled pilot clinic trial to test the ef?cacy of a frared emitting ceramic sleeve as an nt to physical therapy treatment of carpal tunnel syndrome.
Intervention: subjects will follow a r physical therapy (PT) regimen treatment at the Wilfred R. Cameron Wellness Center clinic in Washington, PA. Subjects will be randomly d into 3 (three) experimental groups: a) control: receives PT treatment only. b) bioceramic : receives PT treatment and uses a bioceramic patch for "11" hours after the treatment. c) placebo: receives PT treatment and uses a placebo sleeve (without bioceramics) for "n" hours after the treatment hours after the treatment.
Endpoints measured: 1) Evaluation of pain and disability level: The Boston Carpal Tunnel Syndrome onnaire will be used to determine the ef?cacy of a sleeve of the disclosure in the treatment of carpal tunnel syndrome; and 2) Evaluation of grip strength (muscle strength): The grip strength of the affected nt hand will be measured with a l Spring Hand Dynamometer (Baseline Smedley, USA) with the subjects standing with their elbows extended. The hypothesis is that a sleeve of the sure will be effective in the treatment of humans with carpal tunnel syndrome.
E 24: Uses of bioceramics emitting far infrared energy in the treatment of human in?ammation ] Objective: the aim of this study will be to evaluate the effect of l of the disclosure, such as a shirt, a sleeve, or a pad, comprising a bioceramic that emits far infrared energy re?ecting bioceramics for the treatment of in?ammation.
] Methods: the study will be designed as a controlled clinic trial to test the cy of a frared emitting ceramic sleeve or patch as an adjuvant to treat in?ammation in humans, such as joint in?ammation of humans with arthritis.
Study type: interventional. Subjects will be randomly divided into 3 (three) experimental groups: a) group 1: receives no treatment. b) group 2: wears an apparel of the disclosure: a shirt, a pad, or both, for "11" hours after the ent. b) group 3: wears a control apparel that does not comprise any amic, for "11" hours after the treatment.
Endpoint classi?cation: the ef?cacy of the bioceramics in treating in?ammation will be determined based ont he expression of the following cytokines: either individually or as a group: TNF-d, IL-1 [3, IL-10 and IL-6. The absorbance for the aforementioned cytokines will be measured using a microplate reader at 450 and 550 nm. Cytokine levels of humans will be used to con?rm the anti-in?ammatory effect ofthe bioceramic compositions.
EXAMPLE 25: Self-reported levels of overall pain, overall health levels, overall fatigpe, overall guality of sleep, and overall performance levels of humans participating in a Zumba Fitness program An online questionnaire was used to assess the impact of bioceramic materials in subjects participating in a Zumba ?tness program (ZUMBA ®). ts were asked to identify how many times a week they ced Zumba. Subjects taking zumba classes were selected for further analysis. 10 subjects were asked to answers the following questions: 1) "How would you rate your overall pain level the past 2 weeks? Check the number that best describes your pain. 1 = no pain 10 = worst." FIGURE 12 is a graph illustrating a self-reported reduction of r than 7.5% overall pain levels in human subjects treated with an l of the disclosure. 2) "How you rate your overall health level the past 2 weeks? Check the number that best describes your overall health level 1 = really good 10 = really bad." FIGURE 13 is a _ 63 _ graph illustrating a self-reported improvement of greater than 46% overall health levels of human subjects wearing a shirt of the disclosure while exercising in a Zumba ?tness program. ] 3) "How would you rate your overall fatigue level the past 2 weeks? Check the number that best bes your l fatigue 1 = really good 10 = really bad." FIGURE 14 is a graph illustrating a self-reported reduction of greater than 25 % overall fatigue levels in human subjects wearing a shirt of the disclosure while exercising in a Zumba s m. 4) "How do you rate your overall quality of sleep for the past 2 weeks? Check the number that best describes your overall sleep 1=really good 10: really bad." FIGURE 15 is a graph illustrating a self-reported improvement of greater than 8.5 % overall quality of sleep in human subjects wearing a shirt of the disclosure while exercising in a Zumba ?tness program. ] 5) How would you rate your l performance level for the past 2 weeks.
Check the number that best describes your overall performance 1 = really good 10 = really bad." FIGURE 16 is a graph illustrating a self—reported improvement of r than 7% overall performance level in human subjects wearing a shirt of the disclosure while exercising in a Zumba fitness m.
Conclusion: wearing a bioceramic shirt of the disclosure reduces overall pain, improves l health levels, reduces overall fatigue, improves overall quality of sleep, and improves overall performance levels of humans participating in a Zumba Fitness program.
EXAMPLE 26: Report on the far ed on of bioceramic materials Report of Absolute Emission: according to analysis of emission of radiant power in the infrared region in the range between 9 and 11 micrometers performed at Laboratory of Spectroscopy and Laser Institute of Exact Sciences, Federal University Fluminense, using urn Calorimeter Scientech (Boulder, CO, USA), Model 118, serial number 380802, attached to a unit measures power and energy Scientech, model 473, serial number 364002, in the following materials: 1) plain fabric (not comprising a bioceramic); 2) bioceramic fabric (30 % amics), the formulation of the bioceramic was as described in Example 1; 3) bioceramic fabric (50 % bioceramics), the formulation of the bioceramic was as described in Example 1; The analysis of the emissivity was taken based on the Stefan-Boltzmann equation given by: P = SGT4 Where P is the radiant power per unit area (Watts/m2), c is the emissivity of the wafer (no units), a is the Stefan-Boltzmann constant (5.7 x 10'8 W/m2K4) and T is the temperature of the materials in Kelvins. The emissivity of the material and a dimensionless ty, is a material property, concerns the ability of emission of energy by radiation from its surface. And the ratio of energy radiated by urn particular material to energy radiated by black body urn (e = 1). Any object that is not a true black body has emissivity that is less than 1 and greater than zero.
For analysis the materials were cut into discs of 15 mm in diameter and placed in a thermally insulated oven and maintained electronically in those atures (with a ion of d: 1 ° C). Once in thermal equilibrium, the oven set/ disc was positioned in front of the calorimeter and radiation measurement performed.
The potential measurements per square meter for each al are adjusted as a function of ature in Kelvin high fourth power. The emissivity value is calculated from the slope of the ?tted straight h the method of least squares performed making use of QtiPlot program, free domain.
] The results obtained are as follows: 1) plain fabric (not comprising a bioceramic): emission 0.68 (FIGURE 17) 2) bioceramic fabric (30 % bioceramics): emission 0.70 (FIGURE 18) 3) bioceramic fabric (50 % bioceramics): emission 0.74 (FIGURE 19) The s correspond to a mean value of ements; an average of ?ve measurements for each material, with an estimated error of i 0.02 was performed. In the samples tested the addition of bioceramic materials increased the absolute emissivity of materials which con?rms the greater ce of long—infrared spectral range 9 and 11 micrometers.
EXAMPLE 27: Uses of bioceramics emitting far infrared energy improve ?exibility, increase back, leg, and grip strength, e respiratog; capacity, and enhance cardiorespiratory ?tness Objective: the aim of this study will be to evaluate the effect of apparel of the disclosure in improving ?exibility, increasing back, leg, and grip strength, ing respiratory capacity, and enhancing cardiorespiratory ?tness in a human.
Methods: the study will be designed as a controlled double blind clinic trial to test the statistical impact of a far-infrared emitting bioceramic shirt, sleeve, or patch in improving ?exibility, increasing back, leg, and grip strength, improving respiratory capacity, and enhancing cardiorespiratory ?tness in humans.
Study type: interventional. Subjects will be randomly divided into 3 (three) experimental groups and will receive treatment for at least 6 weeks: a) group 1: receives no treatment. b) group 2: wears an apparel of the disclosure: a shirt, a pad, or both, for "11" hours after the treatment. b) group 3: wears a l apparel that does not comprise any bioceramic, for "11" hours after the treatment. "n" hours can be about 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, 12 hours, 13 hours, 14 hours, 15 hours, 16 hours, 17 hours, 18 hours, 19 hours, 20 hours, 21 hours, 22 hours, 23 hours, or 24 hours during the course of a day.
Endpoint classi?cation: ?exibility, back, leg, and grip strength, respiratory ty, and cardiorespiratory ?tness will be measured as previously described in Examples 11, 13,14,19, and 20.
E 28: Uses of bioceramics emitting far infrared energy as an analgesic in mice Objective: the aim of this study was to evaluate the analgesic effects of distinct bioceramic concentrations and treatment times in an experimental model of CFA induced in?ammation in mice.
Methods: ments were conducted using adult male Swiss mice weighing 25- grams, housed at 22 CC under a 12 hours light]12 hours dark cycle (lights on at 06:00 am), with access to food and water ad libitum. The experiments were performed after approval of the protocol by the Ethics Committee of the Universidade do Sul de Santa Catarina (UNISUL). The animals (n = 8) underwent intraplantar ion (right hind paw) of a solution containing 20 ul of Freud’s complete adjuvant (CFA, 70%). Naive animals were injected with saline solution.
Mechanical nociceptive threshold was assessed as se frequency to 10 presentations of a 0.4g von frey ?lament applied to the animals right hind paw.
In experiment number 1 the animals were placed in their housing boxes for 2 hours on top of a either: (1) a pad composed of 70% BioCorn PVC and 30% bioceramics; (2) a pad composed of 90% BioCorn PVC and 10% bioceramics; or (3) a pad composed of 100% BioCorn PVC and 0% bioceramics. After 2h of exposure mechanical ptive threshold was assessed. Naive animals were not treated.
In experiment number 2 the animals were placed in their g boxes on top of a pad composed of 70% BioCorn PVC and 30% bioceramics for either 0.5, 1 or 2 hours. ards mechanical ptive threshold was assessed. Naive s were not treated. _ 66 _ Results: the results show that the i.pl. injection of CFA induced mechanical hypernociception (P <0.001) which was signi?cantly reduced by acute exposure to the pads containing bioceramics. Exposure to the pad with a higher bioceramic concentration induced longer lasting results (FIGURE 20, panel A). Longer exposure to the bioceramic pad induced longer lasting results (FIGURE 20, panel B).
Conclusion: exposure to amic Pad reduced mechanical hypernociception of atory origin induced by intraplantar injection of CFA in mice in a dose-dependant manner.
EXAMPLE 29: Effect of bioceramics in the growth of organic produce Objective: to evaluate the effect of BioPower® on the growth of hydroponic lettuce (Lactuca sativa).
Methods: experiments were conducted with lettuce (Lactuca sativa) cultivated in a onic . l group was cultivated following standard hydroponics methodology. Experimental group (bioceramics) was treated with amic pellets (30% bioceramic, 70% polystyrene-polypropylene — 1 pound) placed inside the water pump. The lettuce was cultivated for 3 weeks and collected for analyses.
Results: the results indicate that lettuce that received water treated with bioceramics weighted more and presented more leaves in ison to l group.
FIGURE 21 are graphs illustrating the effect of adding bioceramic to a water treatment in a hydroponic system. * 11 = 12, the vertical lines indicate the S.E.M. p < 0.05.
Electrical conductivity (EC) (displayed in microsiemens (uS)) is a measurement of the nutrient solutions ability to conduct an electrical current. Pure water (deionized water) is an tor. It is the conductive substances (or ionized salts) dissolved in the water that determine how conductive the on is. With few ions, when there is a r concentration of nutrients, the electrical current will ?ow faster, and when there is a lower concentration, the current will ?ow slower. This is because the quantity of ved solids in the nutrient solution is directly proportional to the conductivity. Thus, by measuring the EC, one can determine how strong or weak the concentration of the nutrient solution is. In this case, a lower electrical conductivity in the experimental group (BioPower group) denotes a lower concentration of nutrients in the solution, which may suggest that er treated plants absorbed more nutrients than l groups plants. FIGURE 22 is a graph illustrating the lower electrical conductivity of water treated with bioceramics presented from day 16 to 20 in comparison to control group (water only). FIGURE 23 are photographs showing the lettuce at _ 67 _ the start of treatment — lSt day in the system (FIGURE 23 panel A); the lettuce after the ?rst week of treatment E 23 panel B); the e after the third week of treatment (FIGURE 23 panel C); and a photograph of the bioceramic pellets used in the experiment (FIGURE 24).
EXAMPLE 30: Randomizedl double—blind, placebo controlled clinical test of Effect of bioceramics emitting far infrared energy in humans participating in exercise or ?tness programs Objective: to igate the effect of far-infrared emitting ceramic chIR) apparel on humans engaging in Zumba (ZUMBA ®) exercise or ?tness programs.
Background: bioceramics are refractory, inorganic, nonmetallic polycrystalline compounds that due to their inertness in aqueous ions are highly biocompatible and have been extensively used in implants. The bioceramic fabrics and apparel disclosed herein have been optimized for their ability to re?ect/emit far—infrared (FIR). The purpose of this study is to evaluate the effect of fabrics comprising bioceramics in conjunction with sing or ?tness programs in humans.
Design: randomized, double—bind, placebo-controlled trial. Demographics: study will e male and female subjects ofvarious ages.
Intervention: human subjects will participate in Zumba (ZUMBA ®) exercising or ?tness ms. All human subjects will participate in Zumba exercising or ?tness programs at least once a week. ts will be randomly divided into three experimental groups: 0 Group 1 (Non-treatment control — plain apparel): subjects in this group will wear plain control shirts and/or leggings (pants) during Zumba exercise or ?tness programs. 0 Group 2 (Placebo control - shirt and/or leggings (pants) comprising a c that does not re?ect ed energy or rays): subjects in this group will wear l shirts and/or leggings ) comprising a ceramic that does not re?ect infrared energy or rays during Zumba exercise or ?tness programs. 0 Group 3 (Experiment - shirt and/or leggings ) comprising about 50% by weight of the following bioceramic composition: about 18% aluminium oxide A1203, about 14% silicon dioxide 8102, about 50% kaolinite (AlgSl205(OH)4), about 8% zirconium oxide (ZrOz), and about 10% Tourmaline (NaFe2+3A16$i6018(BO3)3(OH) 30H)). Subjects in this group will wear shirts and/or gs (pants) comprising the said bioceramic during Zumba exercise or ?tness programs. Experiments measuring the amount of infrared energy emitted by the aforementioned apparel have been described in EXAMPLE 26.
Additional experiments measuring the amount of infrared energy emitted by shirts before, , and after subjects participate in Zumba exercising or ?tness programs will be performed.
Evaluations: The following evaluation methods will be used to measure the effect of s comprising bioceramics in humans in conjunction with exercising or ?tness programs: Body composition: Body Mass Index (BMI) and waist circumference: body fat percentage will be measured either by the skin fold method or using Bioelectrical Impedance es (BIA). Body composition will be evaluated at least twice: 1) a baseline evaluation will be conducted prior to the beginning of the interventional and control tests; and 2) at least one follow-up evaluation will be conducted at the end of a period of 6 weeks after the start of the intervention.
Cardiovascular : The Harvard Step test will be used to measure "aerobic" or "cardiovascular" ?tness. The Harvard step test is an art acknowledged method to measure how oxygen consumption increases with exercise intensity. VOgmax is de?ned as the highest rate of oxygen consumption attainable during maximal or exhaustive exercise. 0 Harvard Step test protocol: The participant steps up onto, and back down from the step at a rate of 30 completed steps per minute (one second up, one second down) for 5 minutes or until exhaustion. Exhaustion is de?ned as when the participant cannot maintain the ng rate for 15 continuous s. The subject immediately sits down on completion of the test, and the subject’s total number of heart beats are d, based on their pulse at their wrist, within the following time-frames: a) from a minute to a minute- and-a-half after ?nishing; b) from two minutes to two-and-a-half minutes after ?nishing; and c) from three minutes to three—and—a—halfminutes after ?nishing.
Cardiovascular ?tness will be evaluated at the end of Zumba (ZUMBA ®) exercise or ?tness classes: 1) a baseline evaluation will be conducted prior to the beginning of the interventional and control tests; and 2) follow-up tions will be conducted at the end of Zumba (ZUMBA ®) exercise or ?tness classes. The subjects ?tness index score will then be determined by the following equations: Fitness Index = (100 x test duration in seconds) divided by (2 x sum of heart beats in the ry periods).
Flexibility: the ility of each human subject is be measured with the sit-and- reach test (Novel Flex—Tester® Sit & Reach Box). For evaluation each subject will be asked to sit on the floor with knees ?at against the ?oor and the box ?at t the plantar aspect of his/her feet. Then the t stretches out and reaches towards the box moving the distance indicator as far as possible. The mean of 3 measurements will be used in the analysis. Flexibility will be evaluated at the end of Zumba (ZUMBA ®) se or ?tness classes: 1) a ne evaluation will be ted prior to the beginning of the interventional and control tests; and 2) follow-up evaluations will be conducted at least once a week for a total of six weeks at the end of Zumba (ZUMBA ®) exercise or ?tness classes.
Back and Leg strength: Back/leg dynamometer (Baseline, United States) will be used to measure leg and back muscle strength. Leg muscle strength will be recorded at a ng position while both knees are ?exed at an angle of 135°. For evaluation of back muscle strength the participant is asked to stand on the device’s platform with both knees ?exed at an angle of 135°. Using a pronated grip the participant holds the device’s handle bar and slowly straightens his legs up to their l level t using back or shoulder muscles. For evaluations of back muscle strength, subjects are asked to repeat the described procedure while using their back muscles only (knees are kept in extension). Flexibility will be evaluated at the end of Zumba (ZUMBA ®) exercise or ?tness classes: 1) a baseline evaluation will be conducted prior to the beginning of the interventional and control tests; and 2) follow-up evaluations Will be ted at least once a week for a total of six weeks at the end of Zumba (ZUMBA ®) exercise or ?tness classes.
Questionnaires: subjects will optionally be asked to answer questionnaires that aim to assess the effects of the intervention on parameters associated with: general health, sleep, pain, perceived wellness, or quality of life. Exemplary questionnaires e: Form health survey (SF-36); the Pittsburg sleep quality index (PSQI); the McGill Pain Questionnaire; a Wellness Questionnaire; the WHO Quality of Life Questionnaire L-BREF); the questionnaire described in E 25, and/or a number of variations of these.
EXAMPLE 31: Randomized= —blind, placebo controlled clinical test of Effect of bioceramics emitting far infrared energy in humans participating in exercise or ?tness programs ] Objective: To evaluate the effect of far—infrared emitting ceramic (cFIR) shirts on physical ?tness parameters.
Methods: Each participant is randomly divided into 2 (two) experimental groups: 0 Experimental group I (cFIR shirts): each participant wears a cFIR shirt for a minimum of four hours after engaging in physical exercise and a minimum of 4 hours daily in between exercising days. 0 Experimental group II (placebo shirts): Participants wear a placebo shirt (no cFIR) for a minimum of 4 hours after the exercising protocol and a m of 4 hours daily in between exercising days.
Study type: Randomized, double—blind, placebo controlled clinical test. s program: ts will participate in a 1-hor Pilates exercise session 3 times a week. The standardized, progressive treatment protocol will address muscle activation strategies through a variety of movement patterns involving muscle activation strategies through a variety of movement patterns involving muscles extension/contraction. In the protocols the participants will be required to consciously recruit speci?c muscle groups in a variety of movement patterns to exercise all main muscle groups and se physical ?tness as a whole.
] Sample size and population: results from Experimental group I (cFIR shirts) and Experimental group II (placebo shirts) will be compared. A reasonable number of subjects required to provide OL = 0.05 with a power of 0.95 is estimated to be a total of 62 subjects divided between both experimental groups (31 subjects in each group). The required number of subjects was calculated with G*power Statistical Power Analyses version 3.1 (Heinrich-Heine-Universitat Dusseldorf, Germany) and is as follows: 0 is: a priori 0 Input: effect size f= 0.35 / 0t err propb = 0.05 / Power (l-B err prob) = 0.95 / number of groups = 2 / Number of measurments = 9/ ation among rep measures = 0.5 0 Output: noncentrality parameter 7t = 0000 / al F = 4.0011914 / numerator df = 1.0000000 / nator df = 60.0000000 / Total sample size = 62/ Actual power = 0.9532935 Randomization: the participants will be randomly assigned to each group. A research assistant will generate random numbers using a Research Randomizer software. These numbers will be stored on a computer and will be accessible only by the assistant. No strati?cation or blocking strategies will be used.
Suggested number and frequency of evaluations: a baseline evaluation is conducted before the beginning of the study, followed by a weekly evaluation for a total of 6 (six) weeks (minimum).
] Endpoints measured: A) Functional capacity: e: the static balance of each human t is measured with (stabilometric exam) using a re plate (Medicapteurs®, S-Plate® model). The platform records deviations from the center ofpressure (COP) in the anterior-posterior and mediolateral directions. Data acquisition is performed for 30 s under the following conditions: 1) ion 1: human subjects maintain their eyes open during the measurements; condition 2: human subjects maintain their eyes closed during the ements.
Cardiorespiratory capacity: the oxygen consumption (V02) of each human subject is calculated with a regression equation as taught by King et al (J Rheumatol 1999; 26: 2233-7).
B) Body composition: Body mass index, fat mass index, skeletal muscle mass index, percentage of body fat: are calculated with bioelectrical impedance analysis.
] C) Far-infrared emissivity of human subjects g the bioceramic apparel: human subjects are photographed , during and after the exercise ol with an infrared thermographic camera (Flir E6 IR camera, FLIR Systems, Inc). Far-infrared images are used to determine s in body ature triggered by the cFIR emissions and/or physical activity.
D) Far-infrared emissivity of bioceramic shirts and other apparel: FIR Emissivity of the shirts is measured with the Astral Series S Calorimeter AC2500S attached to a handheld meter (Astral A1310 (Scientech, Boulder, CO, USA). Far infrared emissivity of bioceramic shirts with a calorimeter are used to determine FIR emissivity of the shirts in real time. Evaluations are conducted before and after the human subject participates in the exercise protocol (pilates class). Evaluations are optionally conducted during the exercise class.
] E) Blood/saliva samples will be collected for biochemical analyses (muscle stress markers / in?ammation markers / oxidative stress markers): Muscle stress markers: creatine kinase (CK) and lactate dehydrogenase (LDH).
In?ammation markers: interleukin (IL)—lO, IL-6, IL-lB, and Tumor Necrosis factor (TNF)-0L.
Oxidative stress: thiobarbituric acid reactive substances (TBARS), carbonylated proteins, catalase (CAT) and superoxide dismutase (SOD) F) Questionnaires: The ing questionnaires will be used to obtain a personal evaluation from each t: a) the modi?ed Borg Scale of Perceived Exertion (RPE); b) the Pittsburg sleep quality index (PSQI); c) the WHO y of Life-BREF (WHOQOL-BREF) EXAMPLE 32: Comparison of a Bioceramic of the Disclosure with a different bioceramic composition orated into the UnderArmour Cold Gear T-shirt.
] Objective: to compare the analgesic effect of a bioceramic of the claims versus a bioceramic far-infrared emitting bioceramic (cFIR) formulation provided by UnderArmourTM (UA) in a mice 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 conducted using adult male Swiss mice weighing 25-35 g, housed at 22°C under a 12 hour light /12 hour dark cycle (lights on at 06:00), with access to food and water ad libitum. The animals (n = 8) underwent intraplantar injection (right hind paw) of a solution containing 20 ul of Freud’s complete adjuvant (CFA, 70%) to induce mechanical hypersensitivity.
For treatment, either silk—screened fabric comprising either a far-infrared ng bioceramic of the sure or a formulation described by UnderArmourTM was placed at the bottom of the animals’ boxes. After 2 hours of re to the bioceramics, the mechanical ptive threshold of each animal was assessed as a response frequency to 10 tations of a 0.4g von frey fllament applied to the animals right hind paw.
Results: CFA induced mechanical hypemociception in mice was signi?cantly reduced by exposure to a fabric sing a bioceramic of the sure, the bioceramic comprising about 40 wt % to about 60 wt % kaolinite (Alzsi205(OH)4), about 5 wt % to about 15 wt % tourmaline, about 15 wt % to about 25 wt % aluminum oxide (A1203), about 10 wt % to about 20 wt % silicon dioxide (SiOg), and about 1 wt % to about 20 wt % zirconium oxide (ZrOz). CFA induced mechanical hypemociception in mice was not reduced by exposure to a fabric comprising a bioceramic formulation described by UnderArmourTM. The analgesic effect lasted for up to 2 hours.
FIGURE 24 is a graph illustrating the analgesic effect of a far-infrared emitting bioceramic (cFIR) of the disclosure versus the UnderArmourTM formulation in the CFA mouse model of induced mechanical hypersensitivity. N= 8 mice per group, the al lines indicate the S.E.M. * p<0.05.
Conclusion: a bioceramic of the disclosure reduced mechanical ensitivity induced by CFA paw injection whereas a different ation did not provide the sic effect.
EXAMPLE 33: ed Transmittance of Bioceramics.
Objective: to compare the infrared transmittance of a bioceramic of the t disclosure (comprising 18 % aluminium oxide, 14 % silicon dioxide, 50 % kaolinite, 8% zirconium oxide, and 10% tourmaline) to a distinct bioceramic composition ising 20 % um, 3% titanium, ll% magnesium oxide, 6% diiron trioxide, and 60% silica).
Methods: the infrared transmittance of powdered samples (particle size = about micrometers) of the bioceramic powders was taken using a Bruker spectrometer (Model Spectrum VERTEX 70, OPUS 6.5 software). ittance (%) ratings were determined with a resolution of 4 cm‘1 and 72 scans at a scan range from 350 cm‘1 to 4000 cm‘l.
FIGURE 25 A illustrates the infrared transmittance of a bioceramic ition of the instant sure comprising 18 % Aluminium oxide, 14 % silicon dioxide, 50 % kaolinite, 8% zirconium oxide, and 10% tourmaline. FIGURE 25 B illustrates the ed transmittance of a bioceramic composition comprising 20 % aluminum, 3% titanium, ll% magnesium oxide, 6% diiron trioxide, and 60% silica.
EXAMPLE 34: Effect of far-infrared emitting amic apparel on Fibromyalgia human subjects aking Hydrotherapy.
Objectives: to investigate the effect of far-infrared emitting bioceramic apparel on the following ters of human subjects af?icted with fibromyalgia: a) heart rate; b) performance-based ?anctional exercise capacity, c) balance, d) overall ved pain level, e) Fibromyalgia impact, Pain, Quality of Life and Health related Questionnaires; f) blood levels of in?ammatory and anti-in?ammatory nes, and g) blood levels of markers of oxidative stress and activity of anti-oxidative enzymes.
Study Design: Double-blind, placebo controlled trial.
Intervention: Participants followed a Hydrotherapy exercise regimen 3 times a week for a period of 6 weeks and were randomly divided in 2 different groups (Placebo and Bioceramic). Subjects in the placebo group wore "sham apparel", i.e., human subjects wore shirts that did not have far-infrared emitting properties (shirts lacked bioceramics). Subjects in the bioceramic group wore a shirt sing bioceramics every night during sleep (6 to 8 hours), for 6 consecutive weeks, and also during the Hydrotherapy Sessions. Each hydrotherapy session consisted of four phases, i.e., (l) warming up: participants were asked to walk the length of the pool back and forth; (2) active stretching of upper and lower limbs; (3) active exercising of the upper and lower limbs; and (4) relaxation exercises h oscillatory movements. All Phases were guided by the therapist.
Sample size and population: 16 participants: 8 human s in each group with an even age distribution. All participants were women.
Evaluations: evaluations were conducted to assess the following parameters and endpoints: lity, grip strength, heart rate, pain, performance, and onal exercise capacity. The results listed below described the data obtained in the first 6 consecutive weeks of evaluations: A) Heart rate: a heart monitor was used to evaluate ?exibility of the human ts. Number of evaluations: a baseline evaluation was conducted before the beginning of the tests. -up evaluations were conducted before and after every hydrotherapy session (3 times a week for 6 weeks). The results of this test are illustrated in FIGURE 26 and discussed below.
B) Performance-based functional exercise capacity: the six-minute walk test (6MWT) which measures the distance an individual is able to walk over a total of six minutes on a hard, ?at surface was used to evaluate the functional exercise capacity of human subjects.
Number of evaluations: a baseline evaluation was conducted before the beginning of the tests and 6 weeks after the start of tests. The results of this test are illustrated in FIGURE 26 and discussed below.
FIGURE 26 is a graph illustrating the effect of far-infrared emitting bioceramic l on the heart rate and performance based ?mctional exercise capacity of human subjects af?icted with f1bromyalgia that ed a hydrotherapy treatment regimen. Baseline evaluations were performed once a week before any intervention. FIGURE 26 Panels A and B illustrate the cumulative effect of far-infrared emitting bioceramic apparel on the heart rate over a period of 6 weeks before and after hydrotherapy, tively. FIGURE 26 Panel C illustrates the performance-based measure of functional exercise capacity over total distance walked in meters over a period of 6 minutes. Baseline evaluations were med once a week before any intervention. * p < 0.05 indicates statistically signi?cant difference between groups. (paired T- Test 95% con?dence interval - Graphpad Prism software, USA, 2014).
C) Balance: a ometry/baropodometry rm (S—Plate - Medicapteurs, France) was used to evaluate the balance of human subjects. Number of evaluations: a baseline evaluation was ted before the beginning of the tests and a follow-up evaluations was conducted after 6 weeks of treatment. FIGURE 27 is a graph rating the effect of frared emitting bioceramic l on the balance of ?bromyalgia patients that followed a hydrotherapy treatment regimen. FIGURE 27 demonstrates that hydrotherapy in combination with the use of control apparel did not affect the balance of the ts, whereas the use of far-infrared emitting bioceramic statistically reduced latero-lateral oscillations. FIGURE 27 illustrates cumulative _ 75 _ results over a period of 6 weeks. *p < 0.05 indicates a statistically signi?cant difference between groups. d T-Test 95% con?dence interval — Graphpad Prism software, USA, 2014).
D) Overall perceived pain level: Visual Analogue Scale (VAS) was used to assess pain levels. Number of evaluations: a baseline evaluation was conducted before the beginning of the tests. Follow-up evaluations were conducted before and after each hydrotherapy session (3 times a week for 6 weeks). * p < 0.05 indicates statistically signi?cant difference between groups. Baseline evaluations were performed once a week before any intervention. (paired T-Test 95% con?dence interval — Graphpad Prism re, USA, 2014). FIGURE 28 is a graph illustrating the overall perceived pain level effects of human subjects af?icted with ?bromyalgia that are treated with a far-infrared emitting bioceramic l or a sham l. s shown in FIGURE 28 t that: (1) herapy in combination with the use of sham apparel or apparel comprising a bioceramic reduced the patients overall pain levels (compare baseline with before and after for each group — statistical signi?cance not shown in the picture). (2) The results suggest a c effect (cumulative) of the combination treatment.
E) Fibromyalgia impact, pain, quality of life and health related questionnaires: yalgia Impact Questionnaire (FIQ), McGill pain questionnaire and McGill descriptors index, and SF-36 questionnaire cal oning, Pain and l index) were used to assess the impact of a far-infrared emitting bioceramic on ?bromyalgia, pain, quality of ?fe and other health related aspects. Number of evaluations: Baseline evaluation before the beginning of the tests and after 6 weeks. FIGURE 29A is a graph illustrating the results of a algia impact questionnaire (FIQ) (PANEL A), McGill pain questionnaire (PANEL B), and McGill descriptors index (PANEL C).*p<0.05 and **p<0.01 indicate tically signi?cant difference between groups. Baseline evaluations were performed once a week before any intervention. (paired T-Test 95% con?dence interval - Graphpad Prism software, USA, 2014).
Results depicted in FIGURE 29A indicate that: (l) Hydrotherapy in combination with the use of placebo (sham) shirts or bioceramic shirts had a positive effect in the score of the FIQ, although the use of far-infrared emitting bioceramic shirts in combination with hydrotherapy was more effective than hydrotherapy alone (placebo shirt). (2) the use of bioceramic shirts alone statistically affect the McGill pain index and descriptors. Please note that the lower the score the better the result. FIGURE 29B is a graph illustrating the results of a SF- 36 questionnaire; physical functioning (PANEL A), pain (PANEL B), and overall index (PANEL C). Baseline evaluations were performed once a week before any intervention. (paired T-Test 95% nce interval - Graphpad Prism re, USA, 2014). Results depicted in _ 76 _ FIGURE 29B indicate that hydrotherapy in ation with the use of placebo shirts or far- infrared emitting bioceramic had a positive effect in the SF-36 pain as well as overall index whereas the use of amic shirts statistically affected all three scores. Please note that the score can vary from zero to 100, and the lower the score, the worse the prognosis.
F) blood levels of in?ammatory and anti-in?ammatory cytokines. Enzyme- linked Immunoabsorbent Assay (ELISA) was used to assess the blood levels of in?ammatory and anti-in?ammatory cytokines. Number of evaluations: a baseline evaluation was conducted before the beginning of the tests. —up evaluations were conducted before and after each hydrotherapy session (3 times a week for 6 weeks).
G) blood levels of markers of oxidative stress and activity of anti-oxidative enzymes. Enzyme—linked absorbent Assay (ELISA) was used to assess the blood levels of in?ammatory and anti—in?ammatory cytokines. Number of tions: a baseline evaluation was conducted before the ing of the tests. Follow—up evaluations were conducted before and after each hydrotherapy session (3 times a week for 6 weeks).
EXAMPLE 35: Effect of far-infrared emitting bioceramic apparel on Postural Sway of Judo Athletes.
Background: Postural control has been de?ned as the control of the body’s position in space for the purposes of balance and orientation. Postural stability/Balance is an essential component in ing the ef?cacy of interventions for ing balance.
Objectives: To determine the effects of frared radiation emitting ceramic material-impregnated fabrics on postural sway in university judo ?ghters.
Design: Single-blinded randomized placebo lled trial. 17 male and female eers who were randomly allocated to an experimental group (cFIR group, formed by 4 male and 4 female ?ghters that were asked to wear T-shirts impregnated with FIR ng ceramic material during ?ve months); and a control group (No-cFIR group formed by 5 male and 4 female ?ghters that were asked to wear sham/placebo T-shirts, i.e., that were not nated with cFIR emitting ceramic material). Randomization numbers were generated from a randomization site (randomizationcom).
Participants: A total of seventeen judo ?ghters (nine men and eight women) participated in the present study. The following inclusion criteria were ered: (1) each human subject had to take part in of?cial judo competitions during the calendar year; (2) each human subject had to train at least three times per week; (3) each human subject had to be between the ages of 18 and 35; (4) each human subject had to have been practicing Judo for at _ 77 _ least 10. The following exclusion ia were ered: (5) Individuals that presented a history of musculoskeletal injury to the hips, knees or ankles in the previous 2 months; subjects that made use of cological agents or nutritional supplements; ted musculoskeletal injury during the study or that did not wear the shirt for a minimum of 4 hours a day were excluded from the study. All participants were competing at national level competitions. amics and Apparel: The experimental group wore a T-Shirt impregnated with FIR-emitting amic al. The bioceramic material was mixed with a textile ink (Silkscreen Plastisol, Imagine Color, Brazil) and applied to the bioceramic apparel, i.e. the T- shirts. The bioceramic ink was used to silkscreen a repetitive pattern in a 92% polyester, 8% x fabric which was used to impregnate the T-shirts with bioceramics. Sham shirts were silkscreened using the same pattern, although with a 100% plastisol ink (without far-infrared emitting ceramic powder). The average absolute emissivity of the ceramic powder was 93% at wavelengths of 9-ll um, determined with a Scientech meter (Boulder, CO, USA), Astral series S AC2500S model, attached to a unit detector Scientech, model Astral series S A13 lOD.
The control group wore a placebo shirt ut FIR—emitting ceramic material).
Interventions: participants were instructed by a blinded researcher to wear one of the shirts for four (4) hours daily during practice (which includes aerobic training, weight lifting and fight classes) for the duration of the experiments. The intervention lasted ?ve months, with daily use of the bioceramic T-shirts (4 hours during practice). Static e (stabilometry) was assessed before and after the intervention. The training protocol consisted of a 2 hour focus on fitness in the morning period and a 2 hour technical training specific for tatami in the afternoon period, 5 days a week. FIGURE 30 is an organization ?owchart describing the set-up of the study.
Endpoints: advancements in technology have provided the scientific community with computerized platform systems for the quantitative assessment of static balance. These s provide an easy, practical, and ffective method to quantitatively assess functional e through the analysis of postural sway. Such systems record the cements of the centre of foot pressure (COP) by means of s embedded in the rm structure. The movements of the COP re?ect both the horizontal location of the centre-of—gravity (COG) and the ground reaction forces due to the muscular activity of the lower limb, transmitted through the foot. Body sway can be measured as the persistent oscillation of the centre of mass (COM) referring to the antero-posterior (AP) and medio—lateral (ML) axes.
Statistical analysis: For the statistical analysis, the Kolmogorov-Smimov test was used to determine the distribution of the sample, using the parametric test in the analysis of the _ 78 _ pressure plate data. Paired and unpaired t tests were used for the intra and intergroup isons, respectively. The GraphPad prism program (version 5.0, Mac OS) was used for the statistical analysis, with the level of signi?cance set at 5% (p < 0.05).
Results: The total length and area of oscillation of the centre of foot pressure (COP) underwent a signi?cant reduction following the treatment in the mental group, with different degrees of reduction when the eyes were open (p <0.05), but not closed (p > 0.05).
Furthermore, the experimental group exhibited a ion in the mediolateral and anterior- posterior deviations (width) of the COP following treatment in the open eyes analysis.
Analyses were performed for 25 participants (FIGURE 30). The pometric characteristics of the participants are presented in TABLE 1. There was no statistically signi?cant difference between the groups for personal characteristics.
TABLE 1 Groups Control Experimental Individuals (n) Age (years) 21.4 :: 2.6 22.3 i 4.3 Body mass (Kg) 80.2 i 28.2 79.5 i 25.8 Height (m) 1.74 i 0.1 1.69 :t 0.0 BMI (Kg/m2) 25.7 i 6.3 27.5 :t 7.4 Men/woman 5/4 4/4 Time oftraining (years) 10.5 i 4.1 12.1 i 4.4 FIGURE 31 is a graph illustrating the effect of far-infrared emitting bioceramic apparel on postural control. FIGURE 31 displays the results of the les before and after ent with placebo FIR or with FIR, with the values expressed as the mean and standard deviation. The total length and area of oscillation of the COP ent a reduction following treatment in the experimental group, with different degrees of reduction when the eyes were open (p < 0.05) but not closed (p > 0.05). Reduction in body ations in the control group _ 79 _ following placebo ent with the eyes open and closed (p > 0.05) was not observed. These ?ndings demonstrate that FIR interventions led to lesser body oscillation and, consequently, greater orthostatic control. rmore, as shown in TABLE 2, the experimental group exhibited a ion in mediolateral and anterior-posterior deviations (width) of the COP following treatment in open eyes analysis, thereby demonstrating greater orthostatic control, whereas no signi?cant difference was found in the control group (p > 0.05). The ateral and anterior-posterior deviations e speed analysis revealed no statistically signi?cant differences between groups (p > 0.05).
TABLE 2 Analysis with open eyes Control Group Experimental Group Mediolateral-width (mm) 4.750i2.308 7.060i2.092 4.310::2.6l7 4.500::1.6l9* Mediolateral - average speed 1100102160 l.300i0.2280 (mm/s) Anterior-posterior - width (mm) 5.350i2.l78 6.633i2.181 4.250::2.6ll 4.217: Anterior-posterior - average 1.200i0.673 0.879 speed (mm/s) TABLE 3 shows the FIR treatment had no effect on orthostatic control in the mediolateral and anterior-posterior deviations in all analyzed parameters in human subjects with closed eyes (width and average speed) when compared with placebo FIR.
TABLE 3 Analysis with closed eyes ateral-width (mm) 3.522i2.228 3.533i2.856 3.630i2.412 4.350::1.773 Mediolateral - average speed (mm/s) 0.960i0.231 1.217i0.337 0.910::0.213 1.000::0.281 Anterior-posterior - width (mm) 4.556i4.005 4.183i3.056 3.0::1.272 4.133::1.475 Anterior-posterior - e speed 1.200i1.715 1.467i1.480 0.790i0.568 0.850: (mm/s) Conclusion: These ?ndings demonstrate that FIR intervention led to lesser body oscillation and, consequently, greater orthostatic control. The results ed herein suggest that FIR garments may ?nd practical clinical ations in balance disorders or even for performance enhancing apparel in both e activities and competitive sports.
EXAMPLE 36: Effect of far—infrared emittin bioceramic a arel on human sub'ects undertaking a Pilates exercise regimen.
Objectives: to investigate the effect of far—infrared emitting ceramic l on the ?exibility, grip strength, balance, heart rate variability, and quality of sleep.
Study Design: Double-blind, placebo controlled trial.
Intervention: ipants followed a er Pilates ol of one hour session, three times a week for a period of eight weeks and were randomly divided in 2 different groups (placebo and bioceramic). Placebo group wore a sham frared emitting ceramic shirt (no bioceramics) while bioceramic group participants wore a amic shirt that emits far- infrared energy for 8 weeks every night during sleep (6 to 8 hours).
Evaluations: Sample size and population: 30 participants: 15 individuals in each group. Even distribution between sexes/ages.
Flexibility: the sit-and-reach bench test was used to measure ?exibility. A baseline evaluation was conducted before the beginning of the tests and before every Pilates session (3 times a week for eight weeks). Grip Strength: a hand dynamometer was used to measure grip strength. A baseline evaluation was conducted before the ing of the tests and before every Pilates session (3 times a week for eight weeks). Balance: balance was evaluated with a stabilometry/baropodometry platform (S—Plate — Medicapteurs, France). A baseline tion before the beginning of the tests and after six weeks.
FIGURE 32 is a graph illustrating the effect of far-infrared emitting bioceramic l on the ?exibility and grip strength of pilates practitioners. Baseline evaluations were performed once a week before any intervention. *p<0.05 when comparing with baseline _ 81 _ evaluation (T-Test 95% con?dence interval — Graphpad Prism software, USA, 2014). The results ofFIGURE 32 indicate that the use of bioceramic shirts in combination with s sessions statistically increased the participants lity and grip force.
FIGURES 33 and 34 are graphs rating the effect of far-infrared emitting bioceramic apparel on the stabilometry of pilates practitioners. FIGURE 33 is a graph illustrating the effect of far-infrared emitting bioceramic apparel on the stabilometry o- lateral) of pilates tioners: latero-lateral length (Panel A), latero-lateral ce (Panel B), latero-lateral speed (Panel C). FIGURE 34 is a graph illustrating the effect of far—infrared emitting bioceramic apparel on the stabilometry (antero-posterior) of pilates practitioners: anteroposterior length (Panel A), -posterior distance (Panel B), antero-posterior speed (Panel C). *p<0.05 tes statistically signi?cant difference between groups. Baseline evaluations were performed once a week before any intervention. (paired T-Test 95% confidence interval - Graphpad Prism software, USA, 2014). The results shown in S 33 and 34 indicate that the use of bioceramic shirts in combination with Pilates sessions statistically reduced anteroposterior oscillation - overall length, distance from center and speed, whereas the use of placebo shirts statistically ed (to a lesser extent) overall length and distance from center.
Heart rate variability (HRV): heart rate was evaluated with the nerve express unit (Valley Stream, NY, USA). A baseline evaluation before the ing of the tests and after eight weeks. FIGURE 35 illustrates the effect of far-infrared emitting bioceramic apparel on the heart rate variability (HRV) of pilates practitioners. Heart rate ility was evaluated with the nerve s unit y Stream, NY, USA). The results of FIGURE 35 indicate that indicate that the use of far-infrared emitting bioceramic shirts increased rMSSD and HF (High Frequency Power) as well as decreased LF (Low Frequency Power). The combination of these results indicate an overall se of the activity of the parasympathetic autonomic nervous system and decrease in the sympathetic branch. (in this case, an se in the activity of the parasympathetic and a decrease in the activity of the sympathetic indicate a more bene?cial result). The RMSSD (The square root of the mean squared difference between adjacent N-N intervals): commonly used as an index of vagally (Vagus Nerve) mediated cardiac control, which captures respiratory sinus arrhythmia (RSA), the frequent s in heart rate occurring in response to respiration. RMSSD is an accepted measure of parasympathetic activity and correlates with HF of frequency domain analysis. High Frequency Power is a marker of Parasympathetic Activity. Low Frequency Power is a marker of both Parasympathetic and Sympathetic Activity.
Quality of Sleep: quality of sleep was evaluated with the The urgh y of Sleep Questionnaire. A baseline evaluation before the beginning of the tests and after eight weeks. FIGURES 36 and 37 illustrate the results of the Pittsburgh Quality of Sleep Questionnaire. * p < 0.05 when compared with baseline evaluation (paired T-Test 95% con?dence interval - Graphpad Prism re, USA, 2014). Several parameters were evaluated including day dysfunction (FIGURE 36 Panel A), quality of sleep (FIGURE 36 Panel B), sleep ef?ciency (FIGURE 36 Panel C), sleep on (FIGURE 37 Panel A), sleep disturbance (FIGURE 37 Panel B), and PQSI (FIGURE 37 Panel C).
] Results: Results presented in ?gure 4 indicate that the use of far-infrared emitting bioceramic shirts decreased the following indexes (a lower index tes a more bene?cial result): Sleep Duration: Minimum Score = 0 (better); Maximum Score = 3 (worse); Sleep Disturbance: Minimum Score = 0 r); Maximum Score = 3 (worse); Overall Quality of Sleep: Minimum Score = 0 (better); Maximum Score = 3 (worse); and The Pittsburgh Quality of Sleep Questionnaire: Minimum Score = 0 r); Maximum Score = 21 (worse).
Conclusion: The use of far—infrared ng bioceramic shirts during sleep increased the duration of sleep and its ef?ciency, sed the activity of the parasympathetic nervous system as well as decreased the activity of the sympathetic, that can be associated with a more relaxed and better quality sleep. Our studies have demonstrated that far infrared (FIR) produced by amics promotes microcirculation (A), induces reduction of muscular fatigue (B), reduces the effects of stress (C) as well as promotes analgesia and the decrease of in?ammatory conditions (D); it is possible that the combination of these effects leads to a more relaxed and effective sleep.
EXAMPLE 37: Effect of far-infrared emitting bioceramic apparel on weight loss, changes in body measurements, and cellulite reduction.
] Objectives: to igate the effect of shorts comprising bioceramics on weight loss, changes in body measurements, and cellulite ion.
Study type: randomized, double-blind, o controlled. Females randomly allocated to an experimental group (cFIR group, participants are asked to wear shorts impregnated with FIR emitting ceramic material); and a control group (control group, participants are asked to wear shorts that are impregnated with a sham ceramic al, i.e.: a ceramic material that does not provide far infrared energy). Randomization numbers are optionally generated in a randomization site (randomizationcom).
Materials and Methods: 30 healthy adult women with moderate to severe cellulite (cellulite score of at least 11 out of IV) as assessed by a physician investigator are ized in either the experimental group or the control group (15 participants in each group).
Participants are blinded as to which group they have been assigned. Participants wear the shorts daily for at least 6 hours a day for a period of 6 weeks.
Exclusion criteria e: - participants that have received treatment for cellulite reduction in the thighs within one month of the start time of the study; 0 participants with a history of deep vein thrombosis within the past two years; 0 participants with a history of tive heart failure; - ipants diagnosed with cclusive arterial e of the legs; - pregnant or lactating participants; - participants that have used a topical medication usage (e.g.: corticosteroids) within two weeks of the study period; ters to be evaluated: initial, i.e. baseline, weight, cellulite and body ements are measured for each participant prior to the start of the study. Follow up measurements are taken approximately every two weeks from the start day of the study. c parameters being evaluated include: ° weight or body mass index (BMI: weight in kilograms d by height in meters, squared). 0 thigh circumference. The measure of thigh circumference at set points with a ?exible ruler can give an indirect measurement of zed fat and possibly relates to cellulite.
Thigh circumference measurements will be taken of both legs at 18 cm and 26 cm from the superior pole of the a for the lower and upper thigh, respectively, using a ?exible measuring ruler. - cellulite observation. Direct or photographic visualization of skin irregularities such as puckering, dimpling, and nodularities is used to evaluate levels of cellulite. High-quality color digital photographs are taken of the posterior and lateral thighs by an investigator at the following angles: (a) 90° right thigh (b) 45° right thigh (0) 180° right thigh ((1) 90° both thighs ] (e) 90° left thigh (f) 45° left thigh (g) 180° left thigh Photographs are reviewed by ?ve blinded, independent board-certi?ed dermatologists. 0 skin elasticity. Measurement of skin tension with a suction elastometer can give an estimate of the resilience of the dermis, a on of connective tissue helping to gauge the amount of cellulite present. ] 0 Skin electrical conductivity. ical conductivity is used to measure tissue resistance to electron ?ow and determine speci?c percentages of body composition (lean mass, fat mass, water).
EXAMPLE 38: Effect of far-infrared emitting bioceramic apparel on muscle recovery and delayed onset muscle soreness.
Objectives: to igate the effect of amics bottoms (shorts) on muscle recovery after muscle damage protocol (strength), delayed onset muscle soreness, blood levels of CK (creatine ) and LDH (lactate dehydrogenase), blood levels of in?ammatory and anti- in?ammatory cytokines (TNF—oa, IL—6, IL—1 B, IL—10 and IL-4), and blood levels of ive stress as well as of anti-oxidative enzymes ty (TBARS Carbonyls, SOD and catalase).
Study type: double-blind, placebo controlled.
Intervention: subjects are randomly divided into 2 groups (placebo and bioceramics). Subjects in the placebo group wear sham bottoms (no amics) while participants in the amics group wear bottoms comprising far-infrared emitting bioceramics.
Subjects in both groups wear the ention for a period of two hours immediately following the start of the damage protocol (day 0). Subjects also wear the bottoms for onal periods of two hours starting at day l (24 hours following the start of the muscle damage protocol), day 2 (48 hours following the start of the muscle damage protocol), and day 3 (72 hours following the start of the muscle damage protocol) later.
Evaluations: a) Muscle recovery after muscle damage protocol: quadriceps strength is evaluated with isokinetic equipment (De Queen, AR, USA). A baseline evaluation is conducted before the beginning of the tests, immediately after the muscle damage protocol, and on days 1, 2, and 3 (after the use of the bottoms). b) Delayed onset muscle soreness is calculated with a Visual analog scale for pain (VAS) questionnaire. A baseline evaluation is conducted before the beginning of the tests, immediately after the muscle damage ol, and on days 1, 2, and 3 (after the use of the bottoms). c) Blood levels of CK (creatine kinase) and LDH (lactate dehydrogenase), in?ammatory and anti-in?ammatory cytokines (TNF—(x, IL-6, IL-lB, IL-10 and IL-4), oxidative _ 85 _ stress markers and anti-oxidative enzymes activity (TBARS Carbonyls, SOD and catalase) are measure with biochemical analyses (ELISA). A baseline evaluation is conducted before the beginning of the tests, immediately after the muscle damage protocol, and on days 1, 2, and 3 (after the use of the bottoms).
Sample size and population: 30 participants: 15 individuals in each group. Even distribution between sexes/ages.
EXAMPLE 39: Evaluation of the biomodulation induced by the use of infrared emitting ceramic shirts in patients with c obstructive pulmona? e [COPD 2.
Objectives: this study evaluated the biomodulatory effects induced by the use of shirts impregnated with CFIR in patients with Chronic Obstructive Pulmonary Disease .
COPD is de?ned as a chronic and progressive reduction in the air?ow, secondary to an abnormal in?ammatory response of the lungs. One of the features of COPD is the reduction of aerobic capacity and muscle strength, which leads to loss of functionality and se intolerance, negatively impacting upon the patient’s quality of life.
Inclusion criteria: ts diagnosed with COPD of both sexes were recruited according to the following criteria: present clinical diagnosis of COPD and age (subjects were older than 40 years of age).
Exclusion criteria: present incapacitating comorbidity and/or exacerbations of the COPD in the last 6 months.
] For treatment, t-shirts impregnated with a bioceramic of the er® brand were used. The participants wore the t—shirts at night (6-8 hours) for 3 consecutive weeks. The evaluations were performed pre- and post—treatment. In order to fy the functional clinical status of each patient the modified l Research Council Dyspnoea Scale (mMRC) was used. To assess functional capacity the London Chest Activity of Daily Living scale (LCADL) and the six-minute walk test (6MWT) were used. The activity of the autonomic nervous system was assessed by the analysis of heart rate ility. 13 patients were recruited and there were 3 dropouts. Thus, the sample consisted of 10 individuals with COPD, with an average of 63.70 years of age, mean BMI of 26. 19 kg/m2, smoking history of 24.41 years/pack. 40% of the sample were female and 60% male.
] The LCADL questionnaire analysis indicated that patients experienced a statistically signi?cant improvement (p<0.01) when compared with their pretreatment conditions E 38). In pretreatment analyses patients had a mean tion of the total score of 42.88% and 40.36% in the reatment assessment. _ 86 _ In the 6MWT, using the BMI nce in equation 1, the patients showed an increase of 5.37% of the predicting distance. FIGURE 39 illustrate the results of the 6MWT (performance-based functional exercise capacity test) with equation 1 (PANEL A), on 2 (PANEL B) and distance walked before and after treatment (PANEL C). The columns represent the mean values of 10 patients and the verticle lines correspond to the standard error of the mean (SEM). ** P <0.01 when comparing pre to post—treatment condition d t-test).These data were corroborated with the analysis of the equation 2 (using the AHR in the reference equation), in which the increased 8.32% the predicting distance. Furthermore, the results showed an se of 36 meters when compared to the pretreatment evaluation.
] FIGURE 40 illustrate the results of the heart rate variance (frequency domain) of COPD patients assessed before and after treatment. (PANEL A) Low frequency (ms2), (PANEL B) low frequency (nu), (PANEL C) high frequency (ms2), (PANEL D) high frequency (nu).
The columns represent the mean values of 10 patients and the vertical lines correspond to the standard error of the mean (SEM). ** P <0.01 when comparing pre to reatment condition (paired t-test).
FIGURE 41 rate the s of the heart rate variance (time domain) of COPD patients assessed before and after treatment. (PANEL A) RR intervals (PANEL B) HR, intervals (PANEL C) component SDNN, (PANEL D) rMSSD. The s represent the mean values of 10 patients and the vertical lines correspond to the standard error of the mean (SEM).
** P <0.01 when comparing pre to post-treatment condition (paired ).
The heart rate ility analyses, showed a reduction in the low frequency parameters, indicating reduced activity of the sympathetic nervous system. Based on these data, far-infrared treatment through cFIR impregnated shirts increased performance-based functional exercise capacity, reduced daily limitations as well as the activity of the sympathetic nervous system in patients with COPD.
EXAMPLE 40: Evaluation of the effect of far-infrared ng c shirts on oxygen consumption, heart rate and quality of sleep: randomized: double-blind: placebo controlled trial with young baseball players.
Objectives: this Study investigated the effect of far-infrared emitting ceramic shirts on oxygen consumption, heart rate and quality of sleep.
Study Design: Double—blind, placebo controlled trial.
Intervention: Participants were randomly divided in 2 different groups (Placebo and Biopower). Biopower group wore a Biopower far-infrared emitting ceramic shirt (with _ 87 _ amics) while the Placebo group participants wore a sham shirt (with bioceramics) for 6 weeks every night during sleep (6 to 8 hours).
] Evaluations: a) Initial V02 consumption; b) l oxygen consumption (V02Max); c) Aerobic Threshold (AeT), d) Anaerobic Threshold (AnT); e) Heart Rate (Initial, at V02Max, AeT and AnT); and f) Quality of Sleep. Oxygen consumption and Heat rate assessments were conducted with the CardioCoach (V02 evaluation device - KORR Medical logies, Salt Lake City, UT, USA). Quality of sleep was evaluated with the Pittsburgh Quality of Sleep Questionnaire. All participants were evaluated before the beginning of the tests (baseline) and after 6 weeks.
Sample size and population: 30 participants: 15 individuals in a l group (sham ) and 15 individuals in an experimental group (bioceramic shirts). All participants were healthy male baseball s.
] FIGURE 42 illustrates the results on the initial V02 consumption of young baseball players: PANEL A illustrates the initial V02 consumption. PANEL B illustrates the percentage of participants with higher initial V02. PANEL C illustrates the initial heart rate and PANEL D illustrates the percentage icipants with lower initial heart rate. Each column represents the mean of 12-15 ipants, and the vertical lines indicate the S.E.M. NS stands for not statistically signi?cant (T-Test 95% con?dence interval - Graphpad Prism software, USA, 2014). The results presented in FIGURE 42 PANEL A suggest that the use of bioceramic shirts increased initial V02 in a not statistically signi?cant manner.
FIGURE 43 illustrates the results of the V02Max consumption of young ll players: PANEL A illustrates the V02Max and PANEL B illustrate the percentage of participants with higher V02Max. PANEL C illustrate the heart rate of subjects at V02Max and PANEL D illustrate the percentage of participants with lower heart rate at V02Max. Each column represents the mean of 12-15 participants, and the vertical lines indicate the S.E.M. NS stands for not statistically signi?cant. *p < 0.05 when comparing with baseline evaluation (T- Test 95% con?dence interval - Graphpad Prism software, USA, 2014). FIGURE 43 PANEL C suggests that the use of biocerrnaic shirts decreased the participants heart rate at V02Max. In addition, a higher percentage of subjects in the group wearing bioceramic t-shirts presented higher V02Max and lower heart rate than the Placebo group (PANELS B-D) when comparing baseline. Results were measured after 6 weeks for each group.
FIGURE 44 illustrates the results of the aerobic threshold of young baseball players: PANEL A rates the c old (AeT) and PANEL B illustrates the tage of participants with higher AeT. PANEL C illustrates the heart rate at AeT and _ 88 _ PANEL D illustrates the percentage of participants with lower heart rate at AeT. Each column ents the mean of 12-15 participants, and the vertical lines te the S.E.M. NS stands for not statistically signi?cant. *p < 0.05 when comparing with baseline evaluation t 95% con?dence interval - Graphpad Prism software, USA, 2014). Results shown in FIGURE 44 PANEL C suggest that the use of bioceramic shirts decreased the heart rate of subjects at AeT.
Additionally, a higher tage of subjects in the group wearing bioceramic t-shirts presented higher AeT and lower heart rate than the Placebo group (PANELS B-D) when compared with the baseline. Results were measured after 6 weeks for each group.
FIGURE 45 illustrates the results of the anaerobic threshold of young ll players: PANEL A illustrates the anaerobic threshold (AnT) and PANEL A illustrate the percentage of participants with higher AnT. PANEL C illustrate the heart rate at AnT and PANEL D illustrate the percentage of participants with lower heart rate at AnT. Each column represents the mean of 12-15 ipants, and the vertical lines indicate the S.E.M. NS stands for not statistically signi?cant. * p < 0.05 when ing with baseline evaluation (T-Test 95% con?dence interval - Graphpad Prism software, USA, 2014). Results shown in FIGURE 44 PANEL C suggest that the use of bioceramic shirts decreased the participants heart rate at AnT.
Additionally, a higher percentage of Biopower group participants ted higher AnT and lower heart rate than the Placebo group (PANELS B-D) when compared with the baseline.
Results were ed after 6 weeks for each group.
FIGURE 46 illustrates the results of the heart hate recovery 1 minute after evaluation of young baseball players: PANEL A illustrates the heart rate recovery 1 minute after evaluation and PANEL B illustrates the tage of participants with higher recovery percentage PANEL C illustrates the heart rate recovery 2 minutes after evaluation and PANEL D illustrates the tage of participants with higher ry tage. Each column represents the mean of 12-15 participants, and the vertical lines indicate the S.E.M. NS stands for not statistically signi?cant (T-Test 95% con?dence interval - Graphpad Prism software, USA, l 4).
FIGURES 47A and 47B illustrate the results of the Pittsburgh Quality of Sleep onnaire. Each column represents the mean of 12-15 participants, and the vertical lines indicate the S.E.M. * p < 0.05 when comparing with baseline evaluation (paired T-Test 95% con?dence interval - Graphpad Prism software, USA, 2014). The overall results shown in FIGURES 47A and 47B suggest that the use of Biopower far-infrared emitting ceramic shirts statistically decreased the following indexes (a lower index is indicative of a more bene?cial result). FIGURE 47B PANEL E sleep latency: Minimum Score =0 (better); Maximum Score = _ 89 _ 3 (worse); and FIGURE 47B PANEL F The Pittsburgh Quality of Sleep onnaire: Minimum Score = 0 (better); Maximum Score = 21 (worse). The differences between the bioceramics and the control groups for FIGURE 47A PANELS A-C (sleep duration, sleep disturbance, day dysfunction) and FIGURE 47B PANEL A (day dysfunction due to sleepiness) were not statistically signi?cant.
While preferred embodiments of the t ion have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now 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 ed in practicing the invention. It is intended that the following claims de?ne the scope of the ion and that methods and structures Within the scope of these claims and their equivalents be covered thereby.

Claims (12)

Claims:
1. A method for increasing the growth of a plant, said method comprising applying a composition comprising a bioceramic to the plant, the bioceramic comprising: a) about 5 wt % to about 15 wt % tourmaline, b) about 40 wt % to about 60 wt % kaolinite, c) about 15 wt % to about 25 wt % aluminium oxide, d) about 10 wt % to about 20 wt % silicon dioxide, and e) about 1 wt % to about 20 wt % zirconium oxide (ZrO2).
2. The method of claim 1, provided that the amic emits, its, or reflects an infrared wavelength when heated or exposed to heat.
3. The method of claim 2, provided that the infrared wavelength is far infrared that comprises a wavelength from about 1 micrometre to about 1 millimetre.
4. The method of claim 2, provided that the infrared wavelength is from about 3 micrometres to about 15 micrometres.
5. The method of claim 1, provided that the reflectance of the bioceramic at a room temperature of 25°C is at least 80% in an infrared range between about 7 micrometres and about 12 micrometres.
6. The method of any one of claims 1-5, provided that the line comprises NaFe2+3Al6Si6018(B03)3(OH)3OH.
7. The method of claim 1, provided that the largest dimension of any particle in the bioceramic is from about 0.1 micrometres to about 250 micrometres.
8. The method of claim 1 provided that the composition further comprises a substrate, a , a t, a polymer, or an ink.
9. The method of claim 8, provided that the composition r ses a substrate that comprises at least one elastomer.
10. The method of claim 8, provided that the composition comprises a polymer that is selected from the group ting of polyoxybenzylmethylenglycolanhydride, polyvinyl chloride, polystyrene, polyethylene, polypropylene, polyacrylonitrile, polyvinyl butyral, polylactic acid, and combinations thereof.
11. The method of claim 9, provided that the mer is ed from the group consisting of polychloroprene, nylon, a polyvinyl chloride elastomer, a polystyrene elastomer, a polyethylene elastomer, a polypropylene elastomer, a polyvinyl l elastomer, silicone, a thermoplastic elastomer, and combinations thereof.
12. The method of claim 11, provided that the substrate comprises a al selected from the group consisting of wool, silk, cotton, canvas, jute, glass, nylon, polyester, acrylic, ne, polychloroprene, expanded polytetrafluoroethylene-containing laminate fabrics, and combinations thereof. Multiple Energy Technologies LLC By the Attorneys for the Applicant SPRUSON & FERGUSON
NZ725517A 2015-05-01 Bioceramic compositions and biomodulatory uses thereof NZ725517B2 (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201461988837P 2014-05-05 2014-05-05
US201462018085P 2014-06-27 2014-06-27
US201462062686P 2014-10-10 2014-10-10
US201462064939P 2014-10-16 2014-10-16
US201562115567P 2015-02-12 2015-02-12
PCT/US2015/028910 WO2015171467A1 (en) 2014-05-05 2015-05-01 Bioceramic compositions and biomodulatory uses thereof

Publications (2)

Publication Number Publication Date
NZ725517A NZ725517A (en) 2023-09-29
NZ725517B2 true NZ725517B2 (en) 2024-01-04

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