WO2019070871A1 - Champs bioélectromagnétiques thérapeutiques, dispositifs de soulagement de la douleur et procédés associés - Google Patents

Champs bioélectromagnétiques thérapeutiques, dispositifs de soulagement de la douleur et procédés associés Download PDF

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Publication number
WO2019070871A1
WO2019070871A1 PCT/US2018/054190 US2018054190W WO2019070871A1 WO 2019070871 A1 WO2019070871 A1 WO 2019070871A1 US 2018054190 W US2018054190 W US 2018054190W WO 2019070871 A1 WO2019070871 A1 WO 2019070871A1
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WIPO (PCT)
Prior art keywords
subject
aspects
pain relief
composition
relief device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
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PCT/US2018/054190
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English (en)
Inventor
Gary Karpf
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PREZACOR Inc
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PREZACOR Inc
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Priority claimed from US15/724,347 external-priority patent/US10905894B2/en
Application filed by PREZACOR Inc filed Critical PREZACOR Inc
Publication of WO2019070871A1 publication Critical patent/WO2019070871A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0452—Specially adapted for transcutaneous muscle stimulation [TMS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4848—Monitoring or testing the effects of treatment, e.g. of medication
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0484—Garment electrodes worn by the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0492—Patch electrodes
    • A61N1/0496—Patch electrodes characterised by using specific chemical compositions, e.g. hydrogel compositions, adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36132—Control systems using patient feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A61N1/37241—Aspects of the external programmer providing test stimulations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A61N1/37247—User interfaces, e.g. input or presentation means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/2415—Measuring direct current [DC] or slowly varying biopotentials

Definitions

  • This invention relates generally to treatments for pain, inflammation, and skin disorders, among other conditions. More particularly, the invention relates to such treatments through exposure of the body to a low frequency, low voltage
  • bioelectromagnetic field or a bioelectric field, or a biomagnetic field that reduces pain, reduces inflammation, and reduces skin disorders such as acne or eczema.
  • Therapeutic low frequency, low voltage bioelectromagnetic fields, a bioelectric fields, or biomagnetic fields may be used to treat any condition described or exemplified herein.
  • a pai n relief device includes: (i) a body portion including a contact region configured for contacting a subject; and (ii) a monopolar transmitter including a single electrical pole for providing an electrical signal to the body portion for treatment of the subject.
  • a method of treating a subject includes the steps of: (a) applying a body portion of a pain relief device to be in contact with the subject, the pain relief device including a monopolar transmitter including a single electrical pole for providing an electrical signal to the body portion; and (b) transmitting the electrical signal to the subject through the body portion using the monopolar transmitter.
  • a method of determining a medical treatment for a subject includes the steps of: (a) applying test recipes to a plurality of subjects to obtain test data; (b) analyzing the test data to formulate treatment options for application to a subject; and (c) programming a device to include the treatment options.
  • a method of applying a treatment to a subject includes the steps of: (a) applying a treatment to a subject based on a selected treatment option using a programmable pain relief device, the programmable pain relief device including a monopolar transmitter including a single electrical pole for providing electrical signals to the subject; (b) analyzing a condition of the subject through measurements taken using the programmable pain relief device; and (c) adjusting the treatment provided by the programmable pain relief device based on the results of step (b).
  • a method of analyzing one or more subjects includes the steps of: (a) measuring naturally occurring waveforms on a surface of a body of a subject; and (b) analyzing data resulting from the measuring step.
  • aspects of the disclosure provide methods, devices, and compositions for generating beneficial electrical fields for treating one or more conditions in subjects (e.g., humans or other animals, for example domestic and/or agricultural animals).
  • subjects e.g., humans or other animals, for example domestic and/or agricultural animals.
  • the invention features a method for treating pain, comprising directly contacting a surface of a region of the body of a subject in need of treatment for pain with an electrical device powered by an external power source and having a voltage of from about 0.1 millivolts (mV) to about 1000 mV for a period of time sufficient to treat the pain, wherein the device has one point of conductive attachment to the surface and wherein the device emits an electric field comprising a frequency of from about 0.1 Hz to about 2 Hz, thereby treating the pain.
  • an electrical device powered by an external power source and having a voltage of from about 0.1 millivolts (mV) to about 1000 mV for a period of time sufficient to treat the pain
  • the device has one point of conductive attachment to the surface and wherein the device emits an electric field comprising a frequency of from about 0.1 Hz to about 2 Hz, thereby treating the pain.
  • exposing the subject to the low frequency, low voltage bioelectromagnetic field is accomplished by bringing a device or composition which produces the low frequency, low voltage bioelectromagnetic field in proximity to, or in direct contact with, the subject.
  • the device or composition may have one or more electrical properties selected from the group consisting of conductance, semi- conductance, inductance, resistance and capacitance. Proximity within which the device or composition is brought to the subject is preferably less than about 10 centimeters, for example, within about 1 to about 5 centimeters.
  • the frequency of the bioelectromagnetic field is from about 1 Hz to about and 10 Hz.
  • the frequency of the bioelectromagnetic field may be from about 2 Hz to about 7.5 Hz, or even from about 0.5 Hz to about 4 Hz.
  • the voltage of the bioeletromagnetic field may be from about 0.1 mV to about 500 mV.
  • the voltage of the bioelectromagnetic field may be from about 0.1 mV to about 250 mV, or even from about 50 mV to about 250 mV.
  • the frequency of the bioelectromagnetic field may be from about 1 Hz to about 10 Hz and the voltage is from about 0.1 mV to about 500 mV.
  • the frequency may be from about 2 Hz to about 7.5 Hz and the voltage is from about 0.1 mV to about 250 mV.
  • the frequency may be from about 0.5 Hz to about 4 Hz and the voltage may be from about 50 mV to about 250 mV.
  • the device or composition may comprise an external source of power, such as a battery or an AC or DC circuit.
  • a pain-relieving or inflammation-reducing bioelectromagnetic field, bioelectric field, or biomagnetic field is produced when the body is brought contact with or brought into proximity of the device or composition such that the device or composition induces, interacts with, or otherwise synergizes with one or more of the natural electric fields, electromagnetic fields, or magnetic field produced by the body, thereby establishing the low frequency, low voltage bioelectromagnetic field, a bioelectric field, or biomagnetic field that produces a pai n-relieving or inflammation-reduci ng effect.
  • the invention also features methods for treati ng a skin condition .
  • the methods may comprise exposing the ski n of a subject to a low frequency, low voltage bioelectromagnetic field comprising a frequency of from about 0.1 Hz to about 20 Hz and a voltage of from about 0.1 millivolts (mV) to about 1000 mV for a period of time sufficient to treat the skin condition .
  • Exposing the skin of the subject to a low frequency, low voltage bioelectromagnetic field may be accomplished by bringing a device or composition which produces the low frequency, low voltage
  • the device or composition may have one or more electrical properties selected from the group consisting of conductance, semi-conductance, inductance, resistance and capacitance.
  • the subject may be any animal, including a mammal, and more preferably including a human being.
  • the method may further comprise determining whether the device or composition has an electrical frequency response of from about 0.01 to about 20 Hz and an electrical voltage response of from about 0.1 mV to about 1000 mV.
  • the skin condition may be for example, one or more of the following : psoriasis, acne, dermatitis, eczema, insect bites or stings, disorders causing swelling, itching, or scaling of the skin, allergic reactions of the skin to environmental allergens, blisters, ulcers, burns, hyperkeratotic lesions, or skin cancer such as melanoma. Acne, itching, and eczema are preferred.
  • the frequency of the bioelectromagnetic field is from about 1 Hz to about and 10 Hz.
  • the frequency of the bioelectromagnetic field may be from about 2 Hz to about 7.5 Hz, or even from about 0.5 Hz to about 4 Hz.
  • the voltage of the bioeletromagnetic field is from about 0.1 mV to about 500 mV.
  • the voltage of the bioelectromagnetic field may be from about 0.1 mV to about 250 mV, or even from about 50 mV to about 250 mV.
  • the frequency of the bioelectromagnetic field is from about 1 Hz to about 10 Hz and the voltage is from about 0.1 mV to about 500 mV.
  • the frequency may be from about 2 Hz to about 7.5 Hz and the voltage is from about 0.1 mV to about 250 mV.
  • the frequency may be from about 0.5 Hz to about 4 Hz and the voltage may be from about 50 mV to about 250 mV.
  • the proximity within which the device or composition is brought to the subject is less than about 10 centimeters, for example, within about 1 to about 5 centimeters.
  • the device or composition comprises an external source of power, such as a battery or an AC or DC circuit. In some aspects, the device or composition does not comprise an external source of power.
  • a pain-relieving or inflammation-reducing bioelectromagnetic field, bioelectric field, or biomagnetic field is produced when the body is brought contact with or brought into proximity of the device or composition such that the device or composition induces, interacts with, or otherwise synergizes with one or more of the natural electric fields, electromagnetic fields, or magnetic field produced by the body, thereby establishing the low frequency, low voltage
  • bioelectromagnetic field a bioelectric field, or biomagnetic field that produces a pain- relieving or inflammation-reducing effect.
  • a subject can be treated by exposing the surface (e.g., the skin) of the subject to an electrical field (e.g., a low frequency electrical field) in order to relieve pain or discomfort, reduce inflammation, and/or treat other conditions that are responsive to electrical fields as described herein.
  • an electrical field e.g., a low frequency electrical field
  • one or more symptoms e.g., inflammation, pain, etc.
  • tissue beneath the skin e.g., muscles, joints, ligaments, etc.
  • an electrical field having a frequency of between about 0.1 Hz and about 10 Hz.
  • devices and compositions that output electrical fields can be placed on or near (e.g., within a few centimeters) the skin surface of a subject in order to improve or relieve symptoms of one or more conditions in the subject (e.g., human patient).
  • electrical fields e.g., low frequency, for example extremely low frequency, electrical fields
  • 10 Hz e.g., between 0.1 Hz and 10 Hz
  • devices and compositions that output electrical fields can be placed on or near (e.g., within a few centimeters) the skin surface of a subject in order to improve or relieve symptoms of one or more conditions in the subject (e.g., human patient).
  • devices or compositions may generate a suitable electrical field.
  • a device may include a battery or other power source and one or more electrical components suitable for generating a useful electrical field.
  • a device or composition that generates an electrical field without an external power source also can be used.
  • a device or composition may be responsive to external energy sources (e.g., by absorbing energy) and produce a suitable electrical field.
  • a device includes one or more electrical components that are responsive to external energy sources.
  • a device includes a composition (e.g., a material) that is responsive to external energy sources.
  • a composition that includes a plurality of elemental metal particles within a matrix of non-metallic material can be used to provide a suitable electrical field.
  • useful devices and/or compositions are responsive to energy (e.g., electrical fields) produced by the body of a subject (e.g., at the surface of a subject).
  • useful compositions and devices are responsive, without an extrinsic power source, to electrical fields having a frequency of between 0.01 and 100 Hertz (Hz), for example between 0.1 and 10 Hz.
  • the optimal frequency response of a composition or device described herein is between 0.01 and 100 Hz, for example between 0.1 Hz and 10 Hz (e.g., around 0.5 Hz, around 1 Hz, around 2.5 Hz, around 5 Hz, around 7.5 Hz, or around 10 Hz).
  • the voltage response of a device or composition described herein is between 0.1 mVolt (mV) and 5.0 Volts (V), for example between 0.5 mV and 1 V, between 25 mV and 500 mV, or between 50 mV and 100 mV.
  • composition or device described herein is designed to be placed on or near the skin surface of a subject (e.g., within 1-10 cm, for example on the surface, or adjacent to the surface, or on clothing that is near the surface, for example within around 1, 2, 3, 4, or 5 cm of the body surface) where it can absorb energy and generate an electrical output that is therapeutically useful.
  • a composition or device can include one or more electrical components that can provide appropriate frequency and/or voltage responses and/or generate electrical fields with appropriate frequencies and/or voltages as described herein.
  • a power source is included (e.g., a battery or other power source). However, a power source is not required.
  • a composition or device can absorb energy (e.g., from the environment, and/or from the body surface of a subject) and emit a suitable electrical field (e.g., a low frequency electrical field). Accordingly, in some aspects, a composition or device can act as an antenna that absorbs energy (e.g., from a low frequency electrical field that the composition or device is exposed to, for example from the body of a subject).
  • a composition or device is based on the field effects of elemental metal particles within a matrix of non-metallic material (e.g., without requiring a battery or power source for example).
  • a composition comprises a plurality of elemental metal particles incorporated into an organic or synthetic non-metallic matrix (e.g., a non-conducting or semi-conducting matrix).
  • the non-metallic matrix is a plastic, rubber, and/or resin material.
  • the plastic, rubber, or resin material interacts with the elemental metal particles to produce an appropriate electrical field effect.
  • the resulting product is shaped or molded to fit on a body surface of interest.
  • the resulting product can be provided as a flexible sheet, patch, or tape, or in any other suitable configuration.
  • Flexible products can be placed on any surface of the body of interest since they can bend to conform to the shape of the body.
  • the sheet, patch, or tape can include at least one or more adhesive zones or layers (for example, at least one side can include a layer adhesive material) to help attach the sheet or patch to the skin of a patient.
  • adhesive zones or layers are not required .
  • composition or device descri bed herein is useful to treat pain, inflammation, irritation or other conditions described herein on or beneath the skin of a subject (e.g., joint pai ns or tissue inflammation beneath the skin of a subject) .
  • pain, inflammation, irritation or other conditions described herein on or beneath the skin of a subject e.g., joint pai ns or tissue inflammation beneath the skin of a subject
  • neurological and/or neuromuscular conditions can be treated . These and other conditions are described in more detail herein .
  • a composition or device is configured to be placed on the surface of the body of a subject at a location where treatment is desired (e.g., above or near a site of pain, injury, inflammation, or other condition to be treated) .
  • a composition is in the form of a cream or ointment that can be applied to the ski n of a subject.
  • a composition is enclosed within a container so that the composition is not in direct contact with the skin, but wherein the contai ner can be placed on the skin (e.g., it is either shaped and/or has one or more features such as a belt, strap, hook, adhesive, or other feature that is adapted to help maintain contact between the container and the body surface of a subject) .
  • a composition is fixed within an organic or synthetic matrix to form a sheet of material (e.g., a patch or any suitable size or shape) that can be placed on the skin of a subject.
  • a device for example an electrical device
  • the device may include one or more belts, straps, hooks, adhesives, or other features for attachment to the subject (or for attachment to the clothes of a subject).
  • aspects of the disclosure relate to methods for determi ning whether a composition or device has beneficial electrical properties (e.g . , whether the composition or device has appropriate electrical outputs and/or frequency response characteristics) . In some aspects, aspects of the disclosure relate to methods of using compositions or devices that have been determined to have beneficial electrical properties to treat one or more conditions in a subject.
  • conditions that can be treated include skin conditions (e.g., psoriasis, acne, dermatitis, eczema, and other inflammatory skin conditions, for example skin conditions or diseases that cause itching, swelling, and/or scaly skin patches), skin cancer or pre-cancerous conditions such as hyperkeratotic lesions, melanomas, etc.
  • skin conditions e.g., psoriasis, acne, dermatitis, eczema, and other inflammatory skin conditions, for example skin conditions or diseases that cause itching, swelling, and/or scaly skin patches
  • skin cancer or pre-cancerous conditions such as hyperkeratotic lesions, melanomas, etc.
  • itching or pain associated with an insect bite or an exposure to an allergen or other environmental stimulus that causes an inflammatory response e.g., a response to skin contact with poison ivy, poison oak, or other plant or animal stimulus that can cause an inflammatory skin response
  • an inflammatory response e.g., a response to skin contact with poison ivy, poison oak, or other plant or animal stimulus that can cause an inflammatory skin response
  • skin blisters or ulcers e.g., due to sun burns, chemical burns, and/or heat injuries, for example first, second, or third degree burns
  • heat injuries for example first, second, or third degree burns
  • conditions that can be treated include injuries or wounds (e.g., lacerations, bruising, soft tissue injuries, bone fractures, burns, cuts).
  • injuries or wounds e.g., lacerations, bruising, soft tissue injuries, bone fractures, burns, cuts.
  • conditions that can be treated include pain or discomfort (e.g., joint pain, neuromuscular pain, and other forms of pain).
  • pain or discomfort are associated with a disease or condition (e.g., cancer, inflammation, tissue degeneration, injuries, fractures, arthritis, rheumatoid arthritis, osteoarthritis, a degenerative etiology of pain, a discogenic disease, etc.).
  • compositions or devices described herein can be used to relieve pain associated with growth (e.g., in children) or associated with tissue degeneration (e.g., associated with aging).
  • compositions or devices described herein can be used to provide analgesic relief for one or more conditions (for example, analgesic relief may be provided for Osgood Schlatter's Disease, Patella-Femeral syndrome, and/or Chondromalacia).
  • compositions or devices described herein can be used to treat recurring pain (e.g., pain associated with menstrual cramps), seasonal pain or inflammation or irritation, or sporadic pain or inflammation or irritation.
  • compositions or devices described herein can be used to provide relief for pain associated with musculoskeletal injuries and overuse syndromes (e.g., carpel tunnel syndrome).
  • compositions or devices described herein can be used to provide relief for pain associated with surgery. In some aspects, compositions or devices described herein can be used with implants for joint repair, non-union fracture repair, etc.
  • compositions or devices described herein can be used to increase flexibility, mobility, agility, and/or overall activity in subjects that have arthritis (e.g., osteoarthritis), suffer from muscular or neuromuscular degeneration, are injured, have undergone surgery, and/or are undergoing physical therapy.
  • arthritis e.g., osteoarthritis
  • compositions or devices described herein can be used to improve the focus or increase the alertness of a subject. Accordingly, compositions or devices described herei n can be used to treat, reduce, or prevent the effects of sleep deprivation. In some aspects, compositions or devices described herein are useful to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD) or other conditions associated with reduced attention, over-activity, impulsivity, or a combination thereof. In some aspects, compositions or devices described herein can be used to treat sleep disorders, e.g ., to improve sleeping patterns. In some aspects, compositions or devices described herein can be used to treat mood disorders.
  • ADD attention deficit disorder
  • ADHD attention deficit hyperactivity disorder
  • sleep disorders e.g ., to improve sleeping patterns.
  • compositions or devices described herein can be used to treat mood disorders.
  • compositions or devices described herein can be used as sexual enhancement products (e.g ., to increase sensation, to increase libido and/or sex drive, and/or to increase arousal and/or arousal potential) .
  • compositions or devices described herein can be used to treat, prevent, or reduce one or more symptoms of a hangover (veisalgia) associated with alcohol-consumption, for example, headache, nausea, vomiting, irritation, tremor, thirst, dryness of mouth, event recall, discomfort, restlessness, i mpatience, or a combination thereof.
  • a hangover veisalgia
  • a hangover associated with alcohol-consumption
  • headache nausea, vomiting, irritation, tremor, thirst, dryness of mouth, event recall, discomfort, restlessness, i mpatience, or a combination thereof.
  • compositions or devices descri bed herein also can be used to treat one or more of these effects associated with other conditions (non-alcohol related conditions) including vertigo, motion sickness, or other conditions that can cause one or more of these symptoms in a subject.
  • other conditions non-alcohol related conditions
  • vertigo vertigo
  • motion sickness or other conditions that can cause one or more of these symptoms in a subject.
  • compositions or devices described herein can be used as antimicrobial elements.
  • FIGS. 1A-1C illustrate non-li miting examples of circuit configurations that can be used to evaluate the electrical properties of compositions or devices described herein in accordance with various exemplary embodiments of the invention ;
  • FIG. 2 illustrates a composition including elemental metal particles within a matrix of non-conducting or semi-conducting material (the composition as shown includes air pockets, however, in other aspects a composition may have few or no air pockets) ;
  • FIG. 3A is a drawing of a subject usi ng a pain relief device in accordance with an exemplary embodiment of the i nvention
  • FIG. 3B is a detailed view of a portion of FIG. 3A;
  • FIG. 3C is a block diagram view of a pain relief device in accordance with an exemplary embodiment of the invention.
  • FIG. 4A is a drawing of a subject usi ng a pain relief device in connection with a user device, in accordance with an exemplary embodiment of the invention.
  • FIG. 4B is a block diagram illustration of the user device of FIG. 4A, running a software application on the user device, in accordance with an exemplary embodiment of the invention
  • FIGS. 5A-5K are illustrations of various pain relief devices worn by subjects in accordance with various exemplary embodiments of the invention.
  • FIG. 6 is a flow diagram illustrating a method of determining a medical treatment for a subject in accordance with an exemplary embodi ment of the invention.
  • FIG. 7 is a flow diagram illustrating a method of applyi ng a medical treatment to a subject in accordance with an exemplary embodi ment of the invention.
  • aspects of the disclosure relate to methods, compositions, and devices for generating beneficial magnetic, electrical or
  • the generated magnetic, electrical, or electromagnetic fields create, induce, enhance, or synergize with natural magnetic, electrical, and/or electromagnetic fields produced naturally by the body in order to produce a biomagnetic, bioelectric, and/or bioelectromagnetic field that produces a therapeutic effect in the body, including a pai n-reducing, inflammation-reducing, and/or healing effect.
  • the biomagnetic, bioelectric, and/or bioelectromagnetic field that is produced preferably has a low frequency and low voltage, and in some aspects preferably has a lower frequency than the magnetic, electrical, and/or electromagnetic fields produced naturally by the body.
  • the biomagnetic, bioelectric, and/or bioelectromagnetic field that is produced may stimulate the parasympathetic nervous system, and may produce a parasympathetic effect.
  • compositions suitable for use in the methods of the invention which are described in detail hereinafter have one or more electrical properties (e.g ., conductance and/or semi-conductance, inductance, resistance, capacitance, etc.) that provide beneficial electrical frequency and/or voltage responses and/or outputs when placed on or near the body of a subject.
  • a composition or device has the ability to generate an intrinsic electrical charge, hold an electrical charge, and/or discharge energy spontaneously and/or intrinsically.
  • a composition or device absorbs and then discharges an electrical charge. In some aspects, discharge occurs at a lower frequency than absorption of the electrical charge through conductance and/or the field effect of inductance.
  • a device or composition provides a therapeutic field effect when it is in physical proximity and/or contact with the surface of a biological living tissue (e.g., the surface of the body of a subject).
  • a subject may be any animal, and preferably is a mammal.
  • Preferred mammals include farm animals (e.g., horses, cows, etc.), laboratory animals (e.g., rabbits, rats, mice), companion animals (e.g., cats, dogs), and non-human primates. Human beings are highly preferred.
  • the device or composition is in direct contact, or in proximity with the subject, as well as the degree of proximity, may depend, for example, on the characteristics of the subject (e.g., age, sex, height, weight, muscle mass), as well as the type and severity of pain or inflammation being experienced by the subject. For example, proximity within which the device or composition is brought to the subject is preferably less than about 10 centimeters, more preferably from about 1 to about 5 centimeters. Proximity may be less than about 1 cm. The device or composition may directly contacted with the a body surface of the subject.
  • a biologically effective frequency response of a composition or device described herein is within the range of 0.01 Hz to 1000.0 Hz, including about 0.01 Hz to about 500 Hz.
  • a low frequency electrical field has a frequency of about 0.
  • 1 Hz to about 25 Hz (e.g., less than about 25 Hz, less than about 20 Hz, less than about 15 Hz, less than about 10 Hz, less than about 8 Hz, less than about 6 Hz, less than about 5 Hz, less than about 4 Hz, less than about 2 Hz, less than about 1 Hz, less than about 0.5 Hz, or less than about 0.2 Hz, or within a frequency range of from about 0.1 Hz to about 25 Hz, from about 0.1 Hz to about 20 Hz, from about 0.2 Hz to about 5 Hz, or from about 0.5 Hz and 6 Hz).
  • the frequency of the bioelectromagnetic field may be from about 0.1 Hz to about 25 Hz, from about 0.1 Hz to about 20 Hz, from about 0.1 Hz to about 18 Hz, or from about 0.1 Hz to about 15 Hz, or from about 0.1 Hz to about 12 Hz, or from about 0.1 Hz to about 10 Hz, or from about 0.1 Hz to about 8 Hz, or from about 0.1 Hz to about 7.5 Hz, or from about 0.1 Hz to about 6 Hz, or from about 0.1 Hz to about 5 Hz, or from about 0.1 Hz to about 4 Hz, or from about 0.1 Hz to about 3 Hz, from about 0.1 Hz to about 2 Hz.
  • the frequency of the bioelectromagnetic field may be from about 0.5 Hz to about 25 Hz, from about 0.5 Hz to about 20 Hz, from about 1 Hz to about 20 Hz, from about 1 Hz to about 10 Hz, from about 1 Hz to about 8 Hz, from about 1 Hz to about 5 Hz, from about 1 Hz to about 3 Hz, from about 2 Hz to about 16 Hz, from about 2 Hz to about 18 Hz, from about 2 Hz to about 20 Hz, from about 2 Hz to about 14 Hz, from about 2 Hz to about 12 Hz, from about 2 Hz to about 10 Hz, from about 2 Hz to about 8 Hz, from about 2 Hz to about 6 Hz, from about 3 Hz to about 17 Hz, from about 3 Hz to about 15 Hz, from about 3 Hz to about 10 Hz, from about 3 Hz to about 7 Hz, from about 3 Hz to about 6 Hz, from about 4 Hz to about 22 Hz, from about 4 Hz to about 16
  • a biologically effective voltage response of a composition or device described herein is within the range of 0.5 mVolt to 5.0 Volts.
  • a useful low frequency electrical field is between 0.5 mV and up to several V, for example between 0.5 mV and 900 mV, between 1 mV and 500 mV, between 25 mV and 500 mV, around 50 mV, around 100 mV, around 250 mV, around 500 mV, around 750 mV, or around 1 V.
  • the voltage of the bioelectromagnetic field may be from about 0.1 millivolts (mV) to about 1000 mV, or from about 0.1 millivolts (mV) to about 800 mV, or from about 0.1 millivolts (mV) to about 600 mV, or from about 0.1 millivolts (mV) to about 500 mV, or from about 0.1 millivolts (mV) to about 400 mV, or from about 0.1 millivolts (mV) to about 250 mV, or from about 0.1 millivolts (mV) to about 200 mV, or from about 0.1 millivolts (mV) to about 100 mV, or from about 0.1 millivolts (mV) to about 75 mV from about 0.1 millivolts (mV) to about 50 mV, or from about 0.1 millivolts (mV) to about 25 mV, or from about 0.1 millivolts (mV) to about 10 mV.
  • the voltage of the bioelectromagnetic field may be from about 1 millivolts (mV) to about 1000 mV, or from about 10 millivolts (mV) to about 1000 mV, or from about 50 millivolts (mV) to about 1000 mV, or from about 100 millivolts (mV) to about 1000 mV, or from about 250 millivolts (mV) to about 1000 mV, or from about 500 millivolts (mV) to about 1000 mV, or from about 600 millivolts (mV) to about 1000 mV, or from about 750 millivolts (mV) to about 1000 mV, or from about 800 millivolts (mV) to about 1000 mV.
  • the voltage of the bioelectromagnetic field may be from about 100 millivolts (mV) to about 750 mV, or from about 250 millivolts (mV) to about 750 mV, or from about 50 millivolts (mV) to about 500 mV, or from about 50 millivolts (mV) to about 250 mV, or from about 10 millivolts (mV) to about 100 mV, or from about 10 millivolts (mV) to about 50 mV, or from about 1 millivolts (mV) to about 100 mV, or from about 1 millivolts (mV) to about 50 mV, or from about 1 millivolts (mV) to about 25 mV.
  • the frequency of the bioelectromagnetic field is from about 1 Hz to about 20 Hz and the voltage is from about 0.1 mV to about 500 mV. In some preferred aspects, the frequency of the bioelectromagnetic field is from about 2 Hz to about 8 Hz and the voltage is from about 0.1 mV to about 500 mV. In some preferred aspects, the frequency of the bioelectromagnetic field is from about 4 Hz to about 16 Hz and the voltage is from about 0.1 mV to about 500 mV. In some preferred aspects, the frequency of the bioelectromagnetic field is from about 1 Hz to about 10 Hz and the voltage is from about 0.1 mV to about 500 mV.
  • the frequency may be from about 2 Hz to about 7.5 Hz and the voltage is from about 0.1 mV to about 250 mV.
  • the frequency may be from about 0.5 Hz to about 4 Hz and the voltage may be from about 50 mV to about 250 mV.
  • electrical field effects of a device or composition described herein can be evaluated experimentally.
  • a test circuit can be used to determine that the frequency and/or voltage output and/or response of a composition or device described herein are within desirable ranges.
  • one or more non-limiting circuits illustrated in FIG. 1 and/or one or more technique illustrated in the examples can be used to evaluate or measure the frequency or voltage output and response of devices or compositions of interest.
  • compositions or devices that have been tested and shown to have appropriate frequency and/or voltage responses can be further evaluated and optimized by testing their effects on physiological conditions (for example on one or more of the conditions described herein).
  • the methods may optionally include first determining whether the device or composition has an electrical frequency response of from about 0.01 to about 20 Hz and an electrical voltage response of from about 0.1 mV to about 1000 mV, for example, prior to bringing the device or composition into proximity or direct contact with the subject.
  • compositions and devices that produce low frequency electrical fields on or near the body surface of a subject are useful to promote healing and/or pain relief in the subject in addition to being effective for other conditions described herein.
  • Devices and compositions that produce low frequency electrical fields can include batteries or other sources of power, such as an AC or DC circuit.
  • the device or composition does not need to include a power source and instead can generate a suitable low frequency electrical field from absorbed energy (e.g., electromagnetic energy).
  • absorbed energy e.g., electromagnetic energy
  • energy from the body of a subject can be absorbed and emitted in the form of a suitable low frequency electrical field.
  • a therapeutic bioelectromagnetic field, bioelectric field, or biomagnetic field may be produced when the body is brought contact with or brought into proximity of the device or composition that induces, interacts with, or otherwise synergizes with one or more of the natural electric fields, electromagnetic fields, or magnetic field produced by the body, thereby establishing the low frequency, low voltage bioelectromagnetic field, a bioelectric field, or biomagnetic field that produces the desired therapeutic effect.
  • a composition comprising a plurality of elemental metal particles dispersed within a non-metallic matrix (e.g., a nonconducting or semi-conducting matrix, for example an organic matrix) can act as an antenna and produce a low frequency electrical field from absorbed electromagnetic energy.
  • a non-metallic matrix e.g., a nonconducting or semi-conducting matrix, for example an organic matrix
  • Devices and compositions having properties described herein produce a biological field effect that can be used to treat a range of conditions associated with pain, injury, inflammation, and other conditions that are responsive to an electrical effect as described herein.
  • compositions comprising one or more elemental metal structures that are mixed and/or coated with one or more non-conducting and/or semi-conducting materials can have significant therapeutic and/or agricultural uses when placed on or near biological living tissue.
  • certain elemental metal compositions interact with electrical fields (e.g., electrostatic and/or electromagnetic fields) associated with living biological systems (e.g., cells, tissue, organs, organisms, etc.) and this interaction can be used to alter certain biological processes.
  • compositions described herein may be applied to a biological surface (e.g., skin) in the form of a cream or ointment
  • compositions or devices described herein also may be effective when put in close proximity to a biological surface (e.g., a composition may be provided in an enclosure or container that is placed on or near a biological tissue, or a composition may be provided in the form of a plastic, rubber, or resin sheet or film that can be placed on or near a biological tissue, or a device having suitable electrical properties can be placed on or near a biological tissue).
  • compositions having useful electrical properties can be based on a plurality of conducting elemental metal particles (e.g., balls, beads, powder, nanoparticles, etc.) that are separated from each other by a matrix of non-metallic material (e.g., non-conducting or semi-conducting material, for example organic material). Electrical properties of these compositions can be assessed as described herein and compositions of interest can be selected based on their electrical properties and/or further tested for their physiological properties.
  • conducting elemental metal particles e.g., balls, beads, powder, nanoparticles, etc.
  • non-metallic material e.g., non-conducting or semi-conducting material, for example organic material
  • the separating matrix material can be in the form of solid particles that are mixed with the elemental metal particles (e.g., in the form of a dry mixture).
  • the separating matrix material may be in the form of a coating that can be mixed with or applied to the elemental metal particles.
  • the coating may be mixed or applied in a viscous, liquid, or aerosol form. It should be appreciated that a matrix may include a combination of solid particles and coating(s).
  • the resulting composition may be a dry, viscous, or otherwise flowable composition depending on the intended use.
  • the composition may be a solid, liquid, grainy, semisolid, waxy, oily, or low viscosity composition comprising elemental metal particles at least some of which are separated from each other by a matrix of non-conducting and/or semi-conducting material.
  • the separation of the conducting elemental metal particles within a matrix produces certain electrical properties that can interact with living biological systems and alter the nature and/or magnitude (e.g., intensity, speed, etc.) of certain biological processes. It should be appreciated that the nature, dimensions, and relative amounts of the elemental metal and the matrix materials may alter the electrical properties of a composition and may be optimized for a particular biological application.
  • one aspect of the invention provides a biologically active elemental metal composition including one or more elemental metal particles within a matrix of non-conducting or semi-conducting material wherein the composition has been evaluated to determine that it has useful electrical frequency and/or voltage responses and/or outputs.
  • the matrix can be a coating material that is disposed around at least a fraction of the surface area of the particulate elemental metal(s).
  • the matrix may be, or may include, a particulate material that is mixed with the elemental metal particles and that separates at least a fraction of the elemental metal particles from each other.
  • the material may be a semiconducting material.
  • the matrix material can include a silicon dust, sulfur, boron, fiberglass, or other suitable material .
  • the elemental metal particles are incorporated in (e.g., dispersed within) a non-metallic adhesive matrix, a rubber matrix, a plastic matrix, a colloidal matrix, or a combination thereof.
  • suitable non-metallic matrices can include one or more of the following non-limiting materials: rubber, plastic, resin, silicone (e.g., polymerized siloxanes), expanded polytetrafluoroethylene (PTFE, e.g., available under the name Teflon), vinyl, latex, or one or more other organic polymers, elastomers, or colloidal preparations (e.g., one or more
  • hydrocolloids or a combination thereof (e.g., a combination of PTFE and silicone, for example available under the name Silon).
  • one or more oils and/or carboxy-methyl cellulose can be used.
  • a composition can be produced in the form of a flexible sheet (e.g., a patch or a tape) that can readily conform to the contours of a body surface region (or other biological surface), for example when it is applied directly to the skin surface of a subject.
  • a sheet can be produced in a size and configuration that can be readily applied to most body surfaces (e.g., above any joints or muscles, on the back, stomach, arm, leg, or forehead, etc.) depending on the condition being treated.
  • a sheet of material described herein is sticky (e.g., includes an adhesive layer).
  • a flexible sheet as described herein is made of durable material that is resistant to wear and tear associated with its use on the body surface of a subject.
  • a composition is cured or otherwise processed, for example, to modify its physical properties (e.g., to optimize them for a particular use).
  • a backing may be used to further strengthen a flexible patch or sheet.
  • a polymeric backing may be used (e.g., a thermoplastic polyurethane).
  • the elemental metal particles, the non-metallic matrix material, and the adhesive material can be selected to be physiologically compatible (e.g., nontoxic, non-irritant, stable, and/or water-stable).
  • a composition described herein for example in any suitable solid form described herein, including for example a solid molded shape and/or a flexible sheet
  • a coating for example an adhesive coating (e.g., an acrylic adhesive or any other suitable adhesive).
  • a coating covers the entire surface of a composition described herein (e.g., a solid composition), thereby sealing the composition (including, in some aspects, the elemental metal particles and/or the matrix material) within the coating, but still allowing electrical properties of the composition to be effective as described herein.
  • a composition described herein e.g., a solid composition
  • the disclosure provides a body surface (external) appliance or device constructed to fit a certain body part and containing a compound that is specifically formulated to consist of microscopic capacitors that respond to and resonate with naturally occurring electrical fields (e.g., fields produced by muscle, nerve and/or other body tissue).
  • a body surface appliance or device constructed to fit a certain body part and containing a compound that is specifically formulated to consist of microscopic capacitors that respond to and resonate with naturally occurring electrical fields (e.g., fields produced by muscle, nerve and/or other body tissue).
  • compositions or devices described herein may be used in an amount and for a time sufficient to obtain a particular biological outcome.
  • Biological applications include medical, veterinary, and agricultural applications as described herein. It should be appreciated that different amounts and or exposure times may be appropriate for different applications. Effective and/or optimal compositions and exposure conditions (including amount and/or time of exposure) may be determined for any particular application based on the description and examples provided herein.
  • compositions or devices are placed on or near the body of a subject for several hours to several days, weeks, or months (e.g., 6-8 hours per day for up to several weeks, for example up to 12-16 weeks or longer, or for 24 hours/day daily, or for a time period that is sufficient to produce a desired effect).
  • a composition or device can be used (for example, used at night, or worn during the day, or both) for an amount of time that is required to treat a particular condition.
  • compositions or devices are used repeatedly or continuously (for several months or even years) to treat a chronic condition. However, in some aspects, compositions or devices are used only when needed.
  • aspects of the disclosure include non-invasive methods, compositions, and devices, for reducing the severity of pain/inflammation/irritation, delaying the onset of pain/inflammation/irritation, reducing the duration of
  • pain/inflammation/irritation maintaining or increasing mobility
  • reducing or preventing the use of topical creams or other medication e.g., pain killers, anti-inflammatory medications, etc., or any combination thereof
  • increasing the quality of life e.g., activity and/or mobility
  • delaying or postponing an invasive surgical procedure e.g., for pain remediation
  • devices and compositions described herein also may be used for other applications.
  • metal containing compositions can be evaluated as described herein. Aspects of the invention are based, in part, on the discovery that certain compositions including one or more elemental metals can produce electrical fields that can alter biological processes.
  • biologically active compositions including one or more elemental metals are referred to herein as elemental metal compositions.
  • the elemental metal (s) are provided in particulate form.
  • the elemental metal(s) may be coated with one or more non-metallic materials (e.g., non-conducting or semi-conducting materials, for example organic material).
  • elemental metal compositions act as capacitors.
  • elemental metal compositions produce an electrical field (e.g., a low frequency electrical field) that is biologically effective.
  • elemental metal compositions stabilize a biological process when exposed to a biological tissue (e.g., through surface exposure).
  • elemental metal compositions alter a biological process when exposed to a biological tissue (e.g., through surface exposure).
  • elemental metal particles are contained within a matrix such that the particles (or a fraction thereof) are separated from each other by the matrix material.
  • the matrix includes one or more non-metallic coating materials (e.g., materials that can form a coating or film on the surface of the elemental metal particles) to enhance the biological effects of the composition.
  • the matrix includes one or more particulate materials (e.g., powders, grains, etc.) that can be mixed with the elemental metals to enhance the biological effects of the composition.
  • a coating and/or particulate matrix material may be less conducting than an elemental metal particle (e.g., a matrix coating or particle may be non-conducting or semi-conducting).
  • a composition of the invention may have non-uniform conductivity that contributes to its capacitor and/or field effect properties.
  • the size of the elemental metal particles may affect the capacitor and/or field effect properties of a biologically effective composition.
  • the average distance between elemental metal particles in the composition also may affect the capacitor and/or field effect properties of a biologically effective composition.
  • a composition containing smaller elemental metal particles has a greater area of surface contact between the elemental metal(s) and the matrix material(s) resulting in stronger capacitor and/or field effects.
  • the capacitor and/or field effects of an elemental metal composition also may be affected by the type of elemental metal(s) and matrix material(s) that are used.
  • the presence of moisture and/or oxidized metals also may affect (e.g., reduce) the capacitor and/or field effects.
  • a matrix material e.g., coating
  • compositions of the disclosure can be used to impact physiological processes in animals (e.g., humans) and/or plants. Accordingly, compositions including elemental metals may be used for therapeutic purposes to treat certain conditions in humans and/or other animals. In other aspects, compositions including elemental metals may be used for agricultural purposes to promote or stabilize certain physiological states in plants.
  • compositions of the invention may be provided in the form of a topical preparation that can be applied to or contacted to a biological surface (e.g., skin of an animal or surface of a plant).
  • a biological surface e.g., skin of an animal or surface of a plant.
  • compositions of the invention may be provided in a container that is adapted to be exposed or contacted to a biological surface (e.g., without the surface being directly contacted by the elemental metal composition).
  • the elemental metal composition may be formed (e.g., molded) into a solid device having a defined shape (e.g., a shape adapted for contact with a biological surface).
  • one or more elemental metal(s) may be provided in particulate form and contained within a device (e.g., a shaped device).
  • the elemental metal(s) may be provided in a matrix or in a container/sheath.
  • the elemental metal(s) may form a single solid structure.
  • the elemental metal(s) may be in the form of two or more structures having similar or different shapes.
  • the elemental metal(s) are particulate (e.g., balls, filings, grains, granules,
  • the particles all may be of approximately the same size.
  • the particles may range in size.
  • the average size of an elemental metal particles may be smaller or larger than the average size of a matrix particle (e.g., the ratio of elemental metal to matrix particle may be between 1/100 and 100/1, for example between 1/10 and 10/1). However, higher, lower,, or intermediate ratios may be used.
  • the ratio of elemental metal (e.g., by weight or volume) to matrix material (particulate or not) may be between about 1/100 and 100/1 (e.g., between 1/10 and 10/1, about 1/5 to 5/1, or about 1/2 to 2/1, or about 1/1).
  • elemental metal particles are incorporated (e.g., embedded) in a non-metallic plastic, rubber, silicone, polymeric, and/or adhesive matrix (e.g., an organic matrix).
  • a non-metallic plastic, rubber, silicone, polymeric, and/or adhesive matrix e.g., an organic matrix.
  • the resulting composition can be flexible and durable and provided in any suitable form, including, for example a sheet (e.g., a patch or strip) that is sufficiently flexible to readily conform to the shape of a body surface region to which it is applied.
  • an elemental metal composition may have a field effect on biological tissue (e.g., it may alter an electrostatic and/or electromagnetic field of a biological tissue).
  • the field effect may be used to impact one or more biological processes.
  • a biological process may be impacted if it is altered in any manner. For example, a process may be enhanced (e.g., the amplitude, degree, and/or speed of the process may be increased). In other aspects, a process may be suppressed (e.g., the amplitude, degree, and/or speed of the process may be reduced). In further aspects, a process may be established, redirected, or terminated.
  • compositions of the invention may be used therapeutically to treat certain conditions in animals (e.g., humans, pets, agricultural animals, etc.). Conditions that can be treated include skin diseases, pain, inflammation, injuries, and other conditions described herein.
  • compositions of the invention may be used in agriculture and/or horticulture to alter certain aspects of plant physiology. In certain aspects, plant growth, seed germination, fruit and/or vegetable ripening, and/or other aspects of plant physiology may be modified as described herein (e.g., to preserve fruits or vegetables, to increase seed germination, etc.).
  • Elemental metal compositions of the invention may be prepared and/or packaged in different formulations and/or configurations depending on their intended use as described herein.
  • electromagnetic field effect may not be the only factor that influences or determines the type of metal, coating, and/or container that is used for a particular application.
  • properties such as toxicity, availability, cost, ease of use, and other properties described herein, or any combination thereof may inform the choice of appropriate metal(s), coating(s), and/or container(s).
  • compositions and devices comprising certain configurations of one or more elemental metals and methods for their use.
  • Applicant has discovered that certain configurations of elemental metals may have therapeutic and/or biological effect(s) when contacted to a biological tissue surface.
  • therapeutic and/or biological effect(s) are related to an electric field produced by an elemental metal composition, and not to specific chemical interactions between the elemental metal(s) and one or more biological molecules within a biological tissue.
  • an elemental metal may be a transition metal, a metalloid, or other metal that can be stable as a free metal in nature.
  • a transition metal may be scandium, titanium, vanadium, chromium, manganese, iron, cobalt, nickel, copper, zinc, yttrium, zirconium, niobium, molybdenum, technetium, ruthenium, rhodium, palladium, silver, cadmium, hafnium, tantalum, tungsten, rhenium, osmium, iridium, platinum, gold, mercury, ruth erf ordium, dubnium, seaborgium, bohrium, hassium, meitnerium, ununnilium, unununium, or ununbium.
  • Transition metals have valence electrons in more than one shell, and can exist in different oxidation states. Transition metals include metals that can produce a magnetic field (iron, cobalt, and nickel). A metalloid may be boron, silicon, germanium, arsenic, antimony, tellurium, or polonium. Some metalloids are semi-conductors (silicon and germanium). Other metals that can exist as free metals include aluminum, gallium, indium, tin, thallium, lead, and bismuth. These metals only have valence electrons in their outer shell and do not exist in more than one oxidation state.
  • alkali metals and alkaline earth metals are not present as free metals in nature and are not elemental metals as used herein.
  • Alkali metals include lithium, sodium, potassium, rubidium, cesium, and francium.
  • Alkali metals are reactive metals with one electron in their outer shell and they readily lose this electron in an ionic bond with other elements.
  • Alkaline earth metals include beryllium, magnesium, calcium, strontium, barium, and radium. Alkaline earth metals are also very reactive metals and are not stable as free metals in nature.
  • any elemental metal or combination of elemental metals may be included in a biologically effective composition if it imparts suitable electrical field properties to the composition (e.g., when coated with one or more non-metallic materials).
  • suitable electrical field properties e.g., when coated with one or more non-metallic materials.
  • biochemical properties may be considered and evaluated when choosing an elemental metal, even though the biological effectiveness of the composition does not depend on specific chemical interactions between the elemental metal and one or more biological molecules.
  • a composition preferably is not harmful (e.g., is non-toxic), particularly if it is not contained within a physical device that protects an animal, plant, or the environment from exposure to the composition. Accordingly, in some aspects one or more non-harmful metals are used.
  • an elemental metal composition may include only (or primarily) elemental metal(s) that are naturally present in a biological tissue (animal or plant) that is being treated.
  • a composition for use with a human may include one or more of iron, copper, magnesium, and selenium.
  • the relative amounts of two or more elemental metals in a composition may be similar (e.g., the same or about the same) as their relative amounts in a biological tissue.
  • any one or more elemental metals may be included in a composition described herein.
  • any two or more different elemental metals may be combined.
  • Two or more elemental metals may be included as a mixture or as an alloy.
  • a composition may contain a combination of one or more elemental metal(s), and one or more alloys.
  • a composition may contain only elemental metal(s) or only alloy(s). Ratios of different metals (e.g., in mixtures or in alloys) in different compositions of the invention may range from 1 : 1000 to 1000 : 1 (e.g., by weight).
  • a composition may include iron, zinc, copper, aluminum, silicon, or any combination of two or more thereof (e.g., all thereof).
  • a composition may include iron and zinc.
  • a composition may include iron and copper.
  • a composition may include, zinc and copper. Any one of these compositions also may include aluminum, or silicon, or a combination or aluminum or silicon.
  • the ratio of iron to zinc may be between about 10/1 and about 1/1 (e.g., 10/1, 5/1, 2/1, 1/1, for example by weight) or any higher, lower, or intermediate ratio.
  • the ratio of zinc to copper may be between about 10/1 and about 1/1 (e.g., 10/1, 5/1, 2/1, 1/1, for example by weight) or any higher, lower, or intermediate ratio.
  • the ratio of copper to aluminum may be between about 10/1 and about 1/1 (e.g., 10/1, 5/1, 2/1, 1/1, for example by weight) or any higher, lower, or intermediate ratio.
  • the ratio of aluminum to silicon may be between about 10/1 and about 1/1 (e.g., 10/1, 5/1, 2/1, 1/1, for example by weight) or any higher, lower, or intermediate ratio. Any specific combination of the above ratios may be used in a composition of the invention.
  • a combination of particles of one or more (e.g., any 2 or 3, or all 4) of iron, zinc, copper, of aluminum can be present in any ratio of the four elements.
  • a ratio of between about 20/1 and about 1/1 e.g., about 15/1, about 10/1, or about 5/1, for example by weight
  • iron relative to any of the other elemental metals can be used.
  • a ratio of between about 10/1 and about 1/10 (e.g., about 5/1, about 1/1, about 1/5, for example by weight) between any two of zinc, copper, and/or aluminum can be used.
  • a composition can also or alternatively include particles of one or more of the following metals: silver, gold, nickel, tin, carbon, cobalt, selenium, boron, and/or sulfur.
  • a composition can also or alternatively include particles of steel, stainless steel, and/or bronze.
  • iron, zinc, copper, aluminum, and silicon may be present in any ratio of the five elements relative to each other (for example, in relative order of iron/zinc/ copper/aluminum/silicon from about 10,000/1,000/100/10/1 to about 1/1/1/1/1, e.g., about 16/8/4/2/1, about 20/4/2/2/1, about 8/4/2/2/1, about 50/10/2/1/1, about 50/50/25/25/1, about 50/25/5/5/1, for example by weight, or any other combination of ratios described herein).
  • a composition may include oxidized or reduced forms of elemental metal(s).
  • oxidized and/or reduced forms should not represent more than 50%, for example, not more than 25%, not more than 20%, not more than 15%, not more than 10%, not more than 5%, not more than 1%, not more than 0.1 %, or not more than 0.01% of the weight or volume of the elemental metal in the composition.
  • a composition may include metals that are non- elemental in addition to one or more elemental metals.
  • the non-elemental metal(s) do not constitute more than 50%, for example not more that 40%, 30%, 25%, 20%, 15%, 10%), 5%, 1%, or 0.1% of the weight or volume of metal in the composition.
  • the elemental metal(s) may represent more than 50%, for example more than 60%, 70%, 75%, 80%, 85%, 90%, 95%, 99%, or 99.9% of the weight or volume of metal in the composition.
  • the total elemental metal(s) may represent from more than 99% to less than 1% of the total weight or volume of a composition (e.g., about 90%, 75%, 50%, 25%, 20%, 15%, 10%, 5%, 1%, or more or less).
  • a composition or device includes only or at least 50%, 60%, 70%, 80%, 90%, 95%, 99%, or more non-ionic metal .
  • an elemental metal is provided in an inert or non-reactive matrix or coating (e.g., carbonaceous) to prevent the production of ionic metals (e.g., borates, sulfates, etc.).
  • a composition of the invention includes one or more elemental metals in particulate form. Accordingly, in some aspects, an elemental metal is provided in an insoluble form within a matrix.
  • the diameter of a metal particle may range from several mms (e.g., 1 cm) to several nms. However, in certain aspects bigger or smaller particles may be used. Accordingly, a metal particle may be about 1 mm in diameter, about 100 microns in diameter, about 10 microns in diameter, about 1 micron in diameter, about 100 nms in diameter, about 10 nms in diameter, about 1 nm in diameter.
  • a composition may contain from one to dozens, hundreds, thousands, millions, billions or more particles per unit volume.
  • compositions of the invention may include metal balls, metal filings, metal powders, nano-particles (e.g., particles between 0.1 to 10 nm in diameter).
  • particles have a diameter that is less than about 100 microns, for example less than about 50 microns, or less than about 10 microns.
  • particles with a diameter of about 40 microns or less may be selected using a 325 mesh sieve which excludes particles with a diameter greater than about 40 microns.
  • shape of the metal particles is not necessarily spherical.
  • a metal particle may be a sphere or approximated to a sphere in some aspects.
  • a particle may be ovoid, elongated, rectangular, irregular, etc. It should be understood that the reference to a diameter in the context of a particle relates to an average dimension across the particle. In the context of a sphere, a diameter is the diameter of the sphere. In the context of a less-spherical, or non- spherical particle, a diameter refers to an average dimension of the particle (e.g., an average of the longest distance, an average of the shortest distance, or an average of all distances, between two sides of the particle).
  • Particles of different sizes may be obtained or prepared using any suitable method.
  • particle sizes may be selected by sieving elemental metal particles using different meshes (e.g., 200 mesh, 300 mesh, 325 mesh, etc.).
  • compositions and/or devices contain at least one elemental metal coated with a layer or within a matrix of non-metallic material (e.g., a layer or matrix of one or more non-conducting or semi-conducting materials).
  • compositions and/or devices contain at least one elemental metal mixed with a preparation of non-metallic material (e.g., particles of one or more nonconducting or semi-conducting materials).
  • a matrix e.g., a coating
  • a fraction e.g., 100% or less, for example, about 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, 5%, or less
  • the elemental metal particles may enhance one or more electrical properties of the composition.
  • Coatings may be organic material(s) (e.g., organic waxes, etc.), synthetic material(s), or any combination thereof.
  • suitable coating materials include VASELINE® (Conopco, Inc. d/b/a Unilever), petroleum jellies, oils, beeswax, lanolin, etc.). It should be appreciated that certain materials may be used i) as coating materials to impart suitable electrical properties (e.g., conductance, field- effect, capacitance, etc.) on an elemental composition and/or ii) as mixture
  • lanolin may be used as a coating and/or as an emulsifier.
  • a material e.g., lanolin
  • an oil e.g., a mineral, animal, and/or a vegetable oil
  • an animal fat may be used as the matrix or may be added to a different matrix to modify one or more physical properties.
  • one or more other materials or compounds may be used to increase or decrease the malleability, flexibility, and/or stickiness of a composition. However, their effect on the electrical properties of the composition also should be considered (e.g., evaluated experimentally).
  • elemental metal particles are incorporated (e.g., embedded) within a flexible matrix of plastic, rubber, resin, and/or colloidal material.
  • a preparation of elemental metal particles may be mixed with particles of a non-conducting or semi-conducting material (e.g., glass, silicone, wool, cotton, etc.). Any suitable ratio may be used.
  • the size range of the particles of elemental metal may be the same as that of the non-conducting or semi-conducting material. In one embodiment, the size range of the particles of elemental metal may be different from that of the non-conducting or semi-conducting material.
  • a composition may be viscous or semi-solid (e.g., waxy) at room temperature (or other temperature that is characteristic of the environment of use) so that it is easy to apply to a surface (e.g. , skin).
  • a composition may be liquid at room temperature (or other temperature that is characteristic of the environment of use).
  • a composition may be solid or grainy at room temperature (or other temperature that is characteristic of the environment of use). Liquid solutions may be particularly useful for applying to surfaces where physical spreading of a cream/ointment is not practical (e.g., for spreading/spraying over relatively large areas (e.g., agricultural areas).
  • compositions also may be used in situations where a large number of units or volumes of an elemental metal composition may be dispersed over a large area (e.g., an agricultural area).
  • Any form of composition may be contained within an enclosure (e.g., a container such as a solid container, a pouch, a sac, etc.).
  • a composition of the invention may be provided as an aerosol or other form that can be readily dispersed over an area of interest (e.g., a spray that can be sprayed onto a patient skin or a spray that can be sprayed over plants in a greenhouse or on a field).
  • a composition is rubbery or flexible and can be produced in the form of a sheet or patch that can be applied to the skin surface of a subject.
  • a coating is sufficiently malleable to be mixed with an elemental metal so that the coating covers at least a portion of the elemental metal surface thereby forming an interface between the elemental metal(s) and the coating material(s).
  • the coating may cover between 1% and 100%, e.g., about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or about 99% of the surface of the elemental metal (e.g., when inspected visually).
  • FIG. 2 illustrates an example of several metal particles that are covered with a coating material .
  • an elemental metal may be covered with a coating material under conditions that are suitable for preparing a mixture with the coating material covering the elemental material or a portion thereof (e.g., a wax may be mixed with elemental metal at a temperature sufficiently high to melt the wax).
  • a wax may be mixed with elemental metal at a temperature sufficiently high to melt the wax.
  • the resulting preparation subsequently may be used under different conditions (e.g., at a lower temperature).
  • properties may include conductivity, toxicity, availability, malleability, stability, etc., or any combination of two or more thereof.
  • matrix materials may be solid, liquid, particulate, non-particulate, or a combination of two or more thereof.
  • different materials may be selected based on their electrical properties, while also considering certain properties such as toxicity, availability, cost, etc.
  • materials including elemental metals and provide groupings of elemental metals and other materials based on properties that may be useful for certain applications.
  • different properties described herein for individual metals may be considered for compositions including only one elemental metal, a mixture of two or more elemental metals, an alloy of two or more metals, or any combination of two or more thereof.
  • certain metals may be less toxic when in combination with other elements.
  • certain metals may be less toxic or hazardous when in an alloy than when present as a pure metal.
  • elemental metals and matrix materials are evaluated and selected to have suitable electrical properties as described herein in addition to considering other factors.
  • compositions may include only non-hazardous and/or non-radioactive metals (i.e., no hazardous and/or radioactive metals). In one embodiment, compositions may include only non-hazardous and/or non-radioactive alloys (e.g., alloys that contain no metals that are inherently hazardous and/or radioactive).
  • the hazardous properties of a metal may be rated according to HMIS (Hazardous Materials Information System).
  • HMIS Hazardous Materials Information System
  • non-hazardous metals are those with a health rating of 2 or lower (ratings typically range from 0-4).
  • a composition of the invention does not contain any of the following radioactive elements: technetium, bismuth, (metalloids) polonium and astatine, actinium, thorium, protactinium, uranium, neptunium, plutonium, americium, curium, berkelium, californium, einsteinium, fermium, mendelevium, nobelium, lawrencium, rutherfordium, dubnium, seaborgnium, bohrium, hassium, meitnerium, darmstadtium, unununium, ununbium, ununtrium, ununquadium, ununpentium, ununhexium and radioactive elements that are higher on the periodic table.
  • one or more such elements may be used in certain aspects, for example by providing them in a shielding container or device that reduces the amount of damage that may be caused by radiation.
  • certain radioactive metals emit a low energy radiation and may be used without a shielding container or device.
  • indium is only slightly radioactive (beta decay), is not harmful, and may be useful in compositions and methods of the invention .
  • Si milarly, other slightly radioactive metals may be used.
  • a composition of the invention does not contain a spontaneous combustible or explosive solid element or an element with any other dangerous physical property.
  • HMIS Hazardous Material Information System
  • individual metals with Hazardous Material Information System (HMIS) ratings of 3 or greater in flammability and other health properties may be excl uded from compositions of the invention (except in the form of an alloy or mixture that is not as physically dangerous) .
  • HMIS Hazardous Material Information System
  • Examples of metals and alloys that may be physically dangerous include, Lanthanum, Manganese, Hafnium ( 10 micron particles spontaneously ignite), Osmium, and Phosphorus.
  • metals that are generally (grossly) toxic may be excluded from compositions of the invention .
  • metals that may be toxic to animal or plant life include (especially at high concentrations) Hafnium, Tungsten, Manganese, Chromium, Osmium, Cobalt, Thallium, Phosphorus, Mercury, Arsenic, and Lead .
  • any of these metals may be non-toxic or less toxic when used as a stable alloy (e.g ., a manganese, chromium, or phosphorous alloy) .
  • certain of these metals may be important metals for the growth of some organisms (e.g ., plants) and therefore non-toxic when used in suitable amounts (e.g., relatively low concentrations) .
  • EDP Environmental Protection
  • Cadmium, Hafni um, Antimony, Mercury, Arsenic, Lead, Osmium, and Cobalt metals that are toxic when inhaled may be excluded (e.g., Hafnium, Tungsten, Manganese, Osmium, Cobalt, Cad mium, Thallium, Phosphorus, Antimony, Arsenic, and Lead) .
  • metals that are toxic when ingested orally may be excluded (e.g., Cobalt, Cadmium, Thallium, Phosphorus, Anti mony, Arsenic, and Lead).
  • metals that are toxic when absorbed through the skin, and/or metals that are skin irritants, and/or metals that cause ulcerations may be excluded.
  • metals i nclude Hafnium, Manganese, Osmium, Cobalt, Thallium, Phosphorus, and Arsenic.
  • CNS toxic elements or alloys that contain these elements may be excluded (e.g., Tungsten, Manganese (Parkinson's), Lead, Antimony, and Mercury) .
  • toxic metals and/or alloys that destroy mucosal membranes and/or skin may be excluded (e.g., Chromium, Osmium, Thallium, and Phosphorus) .
  • metals that are toxic to plants may be excluded (e.g., Aluminum at high concentrations) .
  • carcinogen metals e.g., as defined by Occupational Safety and Health Administration, Food and Drug Administration, or other
  • any one of more of these elements may be used if provided in a suitable container or protective device that reduces any undesirable properties of the metals to an acceptable level in view of the anticipated exposure to ani mal (e.g., human) and/or plant.
  • nuisance metals may be excl uded. However, in many aspects nuisance metals may be used if the nuisance factor does not outweigh the anticipated or observed physiological benefit.
  • Nuisance metals may have an HMIS rati ng of 2 on health exposure.
  • Non-limiting examples of nuisance metals include: Scandium (Flammability 2-powder, Health 1-inhalation, Reactivity 0) ; Yttrium (Flammability 3-powder spontaneous ignition, Health-1, Reactivity 0) ; Titanium (Flammability 3-powder, Health 1-inhalation, Reactivity 1) ; Vanadium (Flammability 0, Health 2-chronic inhalation, Reactivity 0) is used in medical devices; Niobium
  • Rhenium Femmability 0, Health 0, Reactivity 0
  • Iron Femmability 0, Health- ingestion 2, Reactivity 0
  • Ruthenium Felammability 1, Health 1, Reactivity 0
  • Rhodium Femmability 1, Health 1, Reactivity 0
  • Iridium Femmability 1, Health 0, Reactivity 0
  • Nickel low overall toxicity except on ingestion and then carcinogenic and reactivity is low
  • Palladium Femmability 0, Health 1-inhalation, Reactivity 0) ; Plati num
  • Non-limiting examples of nuisance metalloids include: Boron
  • Non-limiting examples of nuisance non-metals that may be used as a matrix include Carbon (Flammability 1-powder Health 0, Reactivity 0) ; Sulfur (Flammability 1-powder, Health 1-ingestion, Reactivity 0) ; and Selenium
  • compositions may exclude materials (e.g., metals) that cause acute inflammation or that are readily absorbed through the skin of an animal (e.g ., a human) .
  • metals may be used if they are used in low amounts or if they are provided in a container or suitable device that protects the skin from direct contact with the metal .
  • Non-limiting examples of such metals include: Ruthenium (strongly stains skin) ; Nickel and Silver (Argyrosis).
  • useful elements e.g. , elemental metals and alloys
  • i n include: Yttrium, Titanium, Vanadium, Molybdenum, Iron, Nickel, Palladium, Copper, Silver, Zinc, Boron, Aluminum, Gallium, Indium (shot), Carbon, Silicon, Germani um, Tin, Sulfur, Selenium, and Tellurium.
  • Other useful metals that may be more expensive include: Scandium, Niobium, Tantal um, Rhenium, Ruthenium,
  • HMIS 0 or 1 may cause some/minor ski n irritation (HMIS 0 or 1) in finely divided form:
  • Elements that may be readily available in particulate or finely divided powder or nanoparticle forms i n include: Yttrium, Scandium, Titanium, Vanadium, N iobium, Tantalum, Molybdenum, Rhenium, Iron, Ruthenium, Rhodium, Iridium, Nickel, Palladium, Platinum, Copper, Silver, Gold, Zinc, Boron, Aluminum, Indium, Carbon, Silicon, Germani um, Tin, Sulfur, Selenium, and Tellurium (note that Gallium may be available as soft/liquid) .
  • the following elements should be used with care to prevent ingestion by an animal (e.g ., a human) or leaching into the environment: Yttrium, Scandium, Titanium, Vanadium, Tantalum, Molybdenum, Rhenium, Iron, Ruthenium, Rhodium, Iridium, Nickel, Palladium, Platinum, Copper, Silver, Gold, Zinc, Boron, Aluminum, Gallium, Indium, Carbon, Silicon, Germanium, Tin, Sulfur, Selenium, and Tellurium.
  • an animal e.g a human
  • leaching into the environment Yttrium, Scandium, Titanium, Vanadium, Tantalum, Molybdenum, Rhenium, Iron, Ruthenium, Rhodium, Iridium, Nickel, Palladium, Platinum, Copper, Silver, Gold, Zinc, Boron, Aluminum, Gallium, Indium, Carbon, Silicon, Germanium, Tin, Sulfur, Selenium, and Tellurium.
  • Certain of these elements may be non-toxic or even beneficial in low amounts but toxic in higher amounts (e.g., vanadium which is an essential element required in low amounts for some biological tissue or organisms including lower invertebrates, but often toxic in higher amounts). Niobium also should be used with care as it may cross the placental barrier in animals.
  • the following elements may be particularly useful for agricultural applications: Yttrium, Scandium, Titanium,
  • sodium, potassium, calcium, magnesium, phosphorus, and sulfur may be essential macronutrients for certain plants.
  • Chlorine, iron, boron, manganese, zinc, copper, molybdenum, and nickel may be essential micronutrients for certain plants.
  • silicon, sodium, cobalt, and selenium may be beneficial elements for certain plants.
  • Examples of other elements that may be used but that are more difficult to obtain and/or more expensive include: Yttrium, Scandium, Niobium, Tantalum, Rhenium, Ruthenium, Rhodium, Iridium, Platinum, Gold, and Gallium (soft).
  • elements and alloys that have FDA approval may be selected for certain human applications.
  • examples include: Titanium (approved for implants and coatings); Vanadium (approved for implants and coatings); Tantalum (approved for implants, dental and surgical instruments); Molybdenum (approved for prosthetic devices, trace element in plants and animals); Iron (essential element, approved for supplements, and has multiple approvals); Iridium (approved for surgical tools); Palladium (approved for multiple uses in alloys); Platinum (approved for multiple uses); Copper (approved for multiple uses); Silver (approved for multiple uses); Gold (approved for multiple uses); Zinc (approved for multiple uses); Carbon (approved for multiple applications); Silicon (approved for multiple uses); Germanium (alloy, approved for uses); Tin (approved for multiple uses); Sulfur (approved for multiple uses); and Selenium (approved for multiple uses).
  • compositions of the invention may be used for these and/or other uses.
  • the fact that a compound has been approved for one use suggests that it may be suitable (e.g.
  • one or more alloys listed with American Iron and Steel Institute may be used, for example, Iron Alloys with : Aluminum, Silicon, Manganese, Chromium, Vanadium, Molybdenum, Niobium (columbium), Selenium, Titanium, Phosphorus, Cobalt, Tungsten, Boron, Iron-Carbon Alloys with : Silicon, Phosphorus, Sulfur, Manganese, Nickel, Chromium, Molybdenum, Copper, and/or Titanium.
  • AISA American Iron and Steel Institute
  • prosthetic alloys may be used.
  • strongly adherent and passivating surface oxides such as titanium oxide (Ti02) on titanium- based alloys and chromium oxide (Cr203) on cobalt-based alloys may be used.
  • ferrous, cobalt-based, or titanium-based alloys may be used : for example, cold-worked stainless steel; cast Vitallium; a wrought alloy of cobalt, nickel, chromium, molybdenum, and titanium; titanium alloyed with Aluminum and vanadium; and commercial-purity titanium may be used.
  • certain alloys may be modified by nitriding or ion-implantation of surface layers of enhanced surface properties.
  • one or more of the following alloys may be used : as cast Co-Cr-Mo alloy; Bronze: copper and tin plus traces of other elements; Brass: copper and zinc; Bearing alloys: Babbitt metal, tin (Sn), antimony (Sb) and copper (Cu), copper, or silver (Ag); Corrosion- resisting alloys: Stainless steels: Austenitic, Ferritic and Martensitic formulas;
  • Aluminum alloys Al-lithium, chromium (Cr), nickel (Ni), Monel, an alloy of nickel and copper; Inconel : which contains chromium and iron (Fe), Spiegeleisen : iron- manganese-carbon-silicon; Dental alloys: Amalgams silver and mercury (Hg), tin, copper, and zinc (Zn), Gold-base (Au), silver, and copper, palladium and platinum; Vitallium an alloy of cobalt, chromium, molybdenum, and nickel; Die-casting alloys: Zinc-base: aluminum and copper; Aluminum-base: Silicon, copper, iron, silicon; Eutectic alloys: copper with silver, tantalum carbide (TaC) fibers in a matrix of a cobalt- rich alloy; Fusible alloys: lead, cadmium, bismuth, tin, antimony, and indium, bismuth; and/or, Inter metallics: Mu-metal (nickel-iron-copper-moly
  • high-temperature alloys may be used, including one or more of: Stainless steels: Cr, Ni, and molybdenum; both nickel-base and cobalt-base alloys, Nichrome, a nickel-base alloy containing, chromium and iron; Rene-41 contains, chromium, aluminum, titanium (Ti), cobalt (Co), molybdenum, iron, carbon (C), boron (B), and nickel; and/or Molybdenum-base alloys.
  • joining alloys may be used.
  • one or more of the following may be used : copper-zinc, tin brass, silicon-aluminum eutectic alloy, aluminum-containing magnesium, and/or lead-tin alloys.
  • light-metal alloys may be used.
  • one or more of the following may be used : Aluminum and magnesium (Mg), aluminum and copper, and magnesium and aluminum; ternary (three-element) and/or more complex: aluminum-zinc-magnesium systems.
  • any one or more of the following alloys may be used : low-expansion alloys (e.g., Invar (iron- nickel), Kovar (5 iron-nickel- cobalt), etc.); magnetic alloys (e.g., silicon-ferrite); permalloy (nickel-iron) and some comparable cobalt-base alloys; ceramic ferrites; Inicos, Alnico-4 (iron- nickel- aluminum-cobalt), RCo5, where R is samarium (Sm), lanthanum (La), cerium (Ce); precious-metal alloys (e.g., yellow gold which is an Au-Ag-Cu alloy, white gold which is Au-nickel, silver, or zinc, which change the color from yellow to white); the alloy platinum (Pt)-rhodium (Rh)- platinum; sterling silver; shape memory alloys; gold alloyed with cadmium; nickel and titanium known as nitinal; thermocouple alloys; Chromel : nickel and chrom
  • an elemental metal-containing composition described herein may be evaluated or selected based on measured electrical properties (e.g ., to have an output and/or opti mal response within a frequency range of about 0.01 Hz to about 100 Hz, for example from about 0.1 Hz to about 10 Hz, for example, between 0.2 Hz and 5 Hz, between 0.5 Hz and 4 Hz, for example around 1 Hz, around 2 Hz, or around 3 Hz; and/or to have a voltage output or opti mal response within a voltage range of about 0.1 mV to several Vs as described herein, for example around 10 mV, around 50 mV, around 100 mV, around 250 mV, or around 500 mV) .
  • compositions having suitable electrical properties can be tested and/or optimized for their effect on different biological systems. Accordingly, one of ordinary skill can optimize a composition of the invention for a particular use.
  • elements that due to their particular electroresistivity may be useful in elemental metal compositions of the invention include elements with high or low electroresistivity.
  • electroresistivity properties may be used depending on the biological application and the desired biological effect (e.g ., the desired intensity of the biological effect) .
  • Suitable electroresistivity also may be influenced by other metals i n the composition and by the coating material (s) and the configuration of the final compositions (e.g ., an ointment or cream, or enclosed within a container, etc.) .
  • an elemental metal composition may include one or more of a low resistivity, semiconductor, or high resistivity (electron deficient and/or nonmetal) metal (s) .
  • low resistivity metals include: Yttrium, Scandium, Titanium, Vanadium, Niobium, Tantalum, Molybdenum, Rhenium, Iron, Ruthenium, Rhodium, Iridium, Nickel, Palladium, Platinum, Copper, Silver, Gold, Zinc, Aluminum, Gallium, Indium, Silicon, and/or tin.
  • semi-conductors (Metalloids) i include: Boron, Silicon, Germani um, and/or Tellurium.
  • high resistivity elements incl ude Boron (electron deficient), Carbon, Germanium, Silicon, Sulfur, Selenium, and/or Tellurium.
  • elements that due to their electron-nucleus "charging characteristics" i n the form of electronegativity (Pauling) may be useful in elemental metal compositions of the invention include those that are not so high as to be dangerously reactive.
  • electronegativity may yield compositions with a high “capacitance.”
  • Different electronegativity properties may be used depending on the biological application and the desired biological effect (e.g., the desired intensity of the biological effect).
  • Suitable electronegativity also may be influenced by other metals in the composition and by the coating material(s) and the configuration of the final compositions (e.g., an ointment or cream, or enclosed within a container, etc.) .
  • compositions contain one or more metals with electronegativity values between 1.2 and 2.56 Paulings.
  • elements that due to their relatively low, medium or high oxidation potential may be particularly useful in elemental metal compositions of the invention may nonetheless have special handling considerations as discussed herein.
  • low oxidation potential metals include: Gallium, Indium, Silicon, Nickel, Tin, Copper, Silver, Ruthenium, Germanium, Boron, Tellurium Rhodium, Iridium (mildly basic), Palladium, Platinum, Gold, Carbon, and/or Selenium.
  • moderate oxidation potential metals include: Aluminum, Zinc, Iron, Titanium, Niobium (5 micron spontaneous ignition in air), Tantalum, and/or Rhenium.
  • elements with combined extremes in reduction-oxidation potential may be particularly useful in certain combinations.
  • elements with high electro-positive potential include: Yttrium, Scandium, Titanium, Vanadium, Ruthenium, Nickel, Niobium, Zinc, Iron, Aluminum, Gallium, Indium, Tin, Sulfur, Selenium, and/or
  • elements with high electro-negative potential include: Copper, Silver, Gold, Rhodium, Platinum, and/or
  • elements with a moderate degree of negative reduction potential may be useful in some elemental metal compositions of the invention for human use.
  • Zinc, Gallium, Indium, Silicon, Iron, Nickel, Tin, Copper, and/or Silver may be used .
  • these elements form particularly effective energy compounds when mixed with elements from the extremes of the electromotive series.
  • one or more elements with a moderate degree of negative reduction potential may be mixed with one or more elements below 1.6 Pauling such as Molybdenum (1.16), Scandium (1.3), Yttrium ( 1.3), Aluminum (1.5), Titanium (1.5), Tantal um ( 1.5), Vanadium (1.6), and/or N iobium (1.6) .
  • one or more elements with a moderate degree of negative reduction potential may be mixed with one or more elements above 1.9 Pauling such as Rhenium (1.9), Germanium (2.01), Boron (2.04), Tellurium (2.1), Rhodium (2.2), Platinum (2.2), Palladium (2.2), Ruthenium (2.2), Iridium (2.2), Gold (2.4) Sulfur (2.5), Carbon (2.55), and/or Selenium (2.55) .
  • elements with particular electrostatic properties may be useful in elemental metal compositions of the invention .
  • tantalum may be useful, because it has the most capacitance per volume of any substance.
  • Ruthenium may be useful, because it has multi-valence states and high capacitance. Boron may be useful in some aspects, because it has poor thermal and electrical conductivity. Gallium may be useful in some aspects, because it is a "poor metal" and soft/liquid . Indium may be useful in some aspects, because it has a unique response to electric fields. Carbon may be useful in some aspects as a coati ng or other matrix. Carbon also may be used in one or more alloys (e.g., carbon steels), because it has multiple forms with variable electrostatic properties. Silicon may be useful in some aspects, because it is a stable semiconductor. Germanium may be useful in some aspects, because it is a semi-conductor and has a unique response to infra-red radiation. Sulfur may be useful in some aspects, because it has multiple crystalline morphologies. Selenium may be useful in some aspects, because of its rectifier functions and it is radiant to electrical energy. Tellurium may be useful in some aspects, because it is slightly photosensitive.
  • “poor metals” or “post transition metals” may be used (metals occurring between metalloids and transition metals that are more
  • transition metals For example, Aluminum, Gallium, Indium, and/or Tin may be used .
  • certain elements and/or alloys may be particularly useful in elemental metal compositions of the invention.
  • metals with a non- chemical bonding and/or an inducible and/or fluctuating electrostatic "field effect" may be particularly useful.
  • Palladium, Silver, Zinc, Aluminum (“elemental clustering"), Iron, Copper, Gallium, Indium, Carbon, Silicon, Germanium, Sulfur, Selenium, and/or Tellurium may be particularly useful.
  • elements and alloys that have ferromagnetic potential may be non-toxic and useful for compositions of the invention.
  • ferro-magnetic group Iron, Cobalt Nickel, Platinum, and/or Yttrium (slight magnetic susceptibility) may be used.
  • metals in the Platinum metal group may be useful, for example, Platinum, Palladium, Ruthenium, Rhodium, and/or Iridium. In one embodiment, Osmium is not used.
  • metal particles can be mixed with a polymer, gel, colloidal material or other matrix material before the matrix material solidifies (e.g., by polymerizing, setting, curing, or otherwise solidifying), for example, to form an elastic and/or flexible composition that can be placed on a subject.
  • certain metal powders may be thermally unstable in the presence of oxygen, because the powders possess a high surface area per unit mass.
  • Very fine metal powders can burn in air (pyrophoricity) and are potentially explosive. Therefore clean handling of powder may be important. Suitable methods for handling powders may include venting, controlled oxidation to passivate particle surfaces, surface coating, minimization of sparks or heat sources, etc., or any combination thereof.
  • Some respirable fine powders pose a health concern and can cause disease or lung dysfunction : the smaller the particle size, the greater the potential health hazard. Control is exercised by the use of protective equipment and safe handling systems such as glove boxes, respirators, masks, air-handling devices, filters, etc.
  • compositions of the invention may be prepared under conditions that prevent or minimize oxidation and/or reduction of the elemental metals (e.g., prevent or minimize exposure to humidity and/or oxygen (e.g., time and/or amount)).
  • Elements and alloys (that may contain these elements) that are useful to the formulation of elemental metal compositions of the invention may require special handling with precautions in finely divided forms determi ned by OSHA regulations. All may have respiratory exposure limits (due to irritation, but not biological toxins except at high doses of particulates or fumes) defined by OSHA for finely divided form.
  • Certain elements may require special care due to skin irritation, known allergens, and may be absorbed (or cross) through inflamed skin, relatively low (HMIS ratings on flammability-will ignite as powder with a heat source, and health effects, envi ronmental and chemical reactivity generally low HMIS # 1 or less).
  • compositions of the invention may be mixed using any suitable method to obtain elemental metal(s) coated with sufficient coating material(s) in order to exhibit desirable field effect properties.
  • additional materials may be added to an elemental metal composition to improve certain physical characteristics (e.g ., malleability) .
  • an emulsifier such as lanolin may be added.
  • other types of materials may be added, e.g., for stability, to prevent moisture, to prevent oxidation, to prevent microbial growth, etc. (e.g. , sulfur, antioxidant(s), vitamin(s), other stabilizers) .
  • compositions may be prepared so that they are suitably malleable to be molded to fit a particular shape such as the individual shape of a subject's anatomical region that is to be treated (e.g ., joint, back, etc.) or a plant feature.
  • the composition may be molded during preparation to fit a form.
  • composition may be molded when applied to a subject or plant.
  • compositions can be prepared by including an activation step that increases the responsiveness of biological tissue when exposed to the activated composition.
  • activation include heat (e.g ., during or after mixing, or both), exposure to a source of electro-magnetic radiation (e.g ., a Tesla coil) ; exposure to sunlight; exposure to the air; exposure to a source of ionizing radiation ; exposure to electric current (e.g ., by inserting electrodes into the composition and applying an alternating or direct current to the electrodes) ; exposure to a negative ion generator; etc. ; or any combination of two or more of the above.
  • a source of electro-magnetic radiation e.g ., a Tesla coil
  • electric current e.g ., by inserting electrodes into the composition and applying an alternating or direct current to the electrodes
  • a negative ion generator e.g a negative ion generator
  • the ratio of elemental metal to coating material may range from 1 : 1,000 to 1,000 : 1 by weight or volume. However, higher, lower, or intermediate ratios may be used . For example, ratios of 100 : 1, 50 : 1, 10: 1, 5 : 1, 1 : 1, 1 : 5, 1 : 10, 1 : 50, or 1 : 100 may be used. The appropriate ratio may depend on the nature of the metal (e.g. , the size of the particles), the nature of the coating material (e.g. , how waxy or oily it is), and the intended use (e.g ., whether the composition is intended as a cream to be applied to ski n or whether it will be provided i n a container or a sealed device).
  • the nature of the metal e.g. , the size of the particles
  • the nature of the coating material e.g. , how waxy or oily it is
  • the intended use e.g ., whether the composition is intended as a cream to be applied to ski n or whether it will
  • Elemental compositions of the inventions may be formulated as creams, ointments, etc.
  • a cream or ointment may be manufactured based on a coated elemental metal preparation.
  • elemental metal (s) e.g., particulate elemental metal(s)
  • the elemental metal (s) may be added i n a coated form.
  • the elemental metal(s) may be added without a coating and the components of the cream or ointment may act as a coating.
  • Suitable composition percentages of ointment mixtures may be determi ned for maximal biological or healing effect.
  • each of the metals listed herein may have the capability to independently form a biologically active composition at many concentrations in combination with coating materials such as organic substances. Therefore, iron filings and ferrous metal sheets that are coated with organic substances also may become biologically active and can be shaped into many different useful applications. The overall effect of the surface area involved with metallic/organic interface and the capacitance of the substance in total appears to i mpact (and in some aspects maximize) the biological effects.
  • an elemental metal composition may have non-linear or alternating properties (e.g. , non-linear or alternating capacitance and/or field effects) .
  • an elemental metal composition maybe inducible (e.g., have increasing capacitance and/or field effect upon repeated exposure to an electrostatic or electromagnetic field) .
  • Suitable formulations may be identified and used to preserve and/or enhance the nonlinear, alternating, inducible properties of a composition of the invention . Certain formulations may be used to protect a metal from oxidation .
  • a composition of the invention may be formulated with one or more additives (e.g ., preservatives, anti-bacterial, anti-inflammatory, emulsifier, thickener, hardener, etc., or any combination thereof) i n addition to the elemental metal and matrix components.
  • a composition may incl ude an insulating, a corrosion resistant, and/or a hydrophobic or other water excluding material (e.g., i n the form of the matrix or in addition to the matrix) .
  • the electrostatic and/or electromagnetic effects of one or more additives should be considered or assayed, and an appropriate amount should be used to prevent any unwanted effects.
  • a composition may include a homogeneous mixture of components (e.g., an evenly-distributed mixture).
  • a heterogeneous mixture of components e.g., an uneven distribution
  • the distribution may be evaluated, for example, using a microscope.
  • a composition may be provided in a container that is adapted to be contacted or exposed to an animal or plant surface.
  • the container may be flexible, malleable, rigid, or include one or more flexible and/or malleable and/or rigid members or portions.
  • a container may be a sack, bag, or other flexible container.
  • an elemental metal composition of the invention may be wrapped or folded within a support material (e.g., metallic sheet, film, cloth, glass, etc.).
  • a container may be shaped to fit onto a biological structure (e.g., anatomical feature).
  • a container may include one or more features adapted for attachment to a biological structure. Examples of attachment features include belts, straps, hooks, etc.
  • a container may be shaped to attach to a biological structure.
  • the container may be shaped as a cylinder, sheath, glove, sock, hat, etc.
  • the container may be shaped or designed to fit into an article of clothing (e.g., hat, glove, shoe, coat, etc.).
  • a container may be shaped as a disc or sphere (e.g., a ball).
  • a composition of the invention may be shaped as a disc or sphere (e.g., a ball).
  • a disc or sphere may be between about 1 and about 5 inches in diameter. However, smaller or larger discs or spheres may be used (e.g., less than 1 inch, less than 0.5 inches, etc., or more than 1 inch, more than 5 inches, more than 10 inches, etc.).
  • a disc may be about 2 inches in diameter.
  • a disc may be of any suitable thickness.
  • a disc may be between 1/10 and 10 inches thick (e.g., about 1/8, 1/4, 3/8, 1/2, 5/8, 3/4, 7/8, 1, 5, or more inches thick).
  • a composition of the invention may be provided in a shape that roughly approximates a geometric shape.
  • a composition may be provided in a pad.
  • a composition may be shaped to fit an anatomical feature (e.g., of a plant or animal, for example of a human) as described in more detail herein.
  • a container may be adapted to receive one or more biological materials.
  • a belt or item of clothing may be adapted to receive material, with or without a surrounding container material .
  • the material may be provided in any shape.
  • One or more separate packages may be added to a belt, an item of clothi ng, furniture (e.g ., chair, couch, bed, car-seat), sheet, or any other suitable support.
  • furniture e.g ., chair, couch, bed, car-seat
  • 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more packages e.g., discs, spheres, cubes, etc.
  • packages may be affixed or introduced into a single or separate spaces or pockets in a belt, an item of clothing, furniture, sheet, or any other suitable support.
  • layers of an elemental metal composition may be separated by one or more layers of a support material (e.g., sheathing, for example fiberglass screening) .
  • layers of compositions may be included between layers of different materials (e.g., solid metal foil, non-conducting felt, etc. , or any combination thereof) to modify the intensity of a field effect (e.g., to enhance or reduce the effect) .
  • a container may contain dry, sticky, waxy, and/or low viscosity elemental compositions. Any suitable mass of an elemental metal composition may be used, for example, included in a container. For example, less than 1 g, 1- 10 g, 10-100 g, 100- 500 g, 500 g to 1 kg, 1-10 kg, 10-50 kg, or more material may be used (e.g ., with or without a surrounding container) .
  • a container may be adapted to be mixed with biological materials (e.g ., a pod or small container that can be mixed with seeds or fruit or vegetables or other biological materials) .
  • a suitable storage container may be used to preserve or maintain an electrostatic charge and/or an activated state of an elemental metal composition .
  • a container may be manufactured from any suitable material (e.g., glass, cotton, wool, sil k, metals, plastics, wood, synthetic fibers, natural fibers, polymeric material, resins, etc.) .
  • a container may be of a material that is untreated (e.g., that has not been treated with a chemical additive, bleachi ng agent,
  • a container does not include (e.g ., does not include a significant amount of, for example less than 50%, less than 40%, less than 30%, less than 20%, less than 10%, less than 5%, less than 1% by weight or vol ume of) a material that reduces the electronegative properties of an elemental composition (or that results in an electropositive effect) .
  • plastic containers e.g. , polyethylene and/or polypropylene plastic contai ners
  • a container may be used to protect a metal from oxidation .
  • a container may include a desiccant.
  • a container may be air-tight and/or provide a moisture barrier.
  • aspects of the invention include therapeutic applications for animals and humans as described herei n.
  • medical applications in human include treatments of skin conditions (e.g ., psoriasis, skin cancer or pre-cancerous conditions such as hyperkeratotic lesions, melanomas, etc. ) .
  • the invention also provides methods for treating a ski n condition in a subject in need thereof.
  • the methods comprise exposing the subject to a low frequency, low voltage
  • bioelectromagnetic field comprising a frequency of from about 0.1 Hz to about 20 Hz and a voltage of from about 0.1 millivolts (mV) to about 1000 mV for a period of time sufficient to treat the skin condition .
  • the period of time sufficient to treat the skin condition is at least one minute.
  • the period of time may be several minutes, or several hours.
  • the period of time may be spread out over a number of days, or weeks, or months, or even a year or more.
  • Skin conditions include, but are not limited to, psoriasis, acne, dermatitis, eczema, insect bites or stings, disorders causi ng swelling, itching, or scaling of the skin, allergic reactions of the skin to environmental allergens, blisters, ulcers, burns, hyperkeratotic lesions, or melanomas.
  • the devices and compositions suitable for use in the method of treating a skin condition have one or more electrical properties (e.g., conductance and/or semi-conductance, inductance, resistance, capacitance, etc.) that provide beneficial electrical frequency and/or voltage responses and/or outputs when placed on or near the body of a subject.
  • electrical properties e.g., conductance and/or semi-conductance, inductance, resistance, capacitance, etc.
  • the low frequency, low voltage bioelectromagnetic field useful for the method of treating a skin condition should have a frequency and voltage in the same ranges as descri bed hereinabove for the method of treating pai n or inflammation, i .e., a frequency of from about 0.1 Hz to about 20 Hz and a voltage of from about 0.1 millivolts (mV) to about 1000 mV.
  • the frequency of the bioelectromagnetic field useful for the method of treati ng a skin condition may be from about from about 0.1 Hz to about 18 Hz, or from about 0.1 Hz to about 15 Hz, or from about 0.1 Hz to about 12 Hz, or from about 0.1 Hz to about 10 Hz, or from about 0.1 Hz to about 8 Hz, or from about 0.1 Hz to about 7.5 Hz, or from about 0.1 Hz to about 6 Hz, or from about 0. 1 Hz to about 5 Hz, or from about 0.1 Hz to about 4 Hz, or from about 0.1 Hz to about 3 Hz, from about 0.1 Hz to about 2 Hz.
  • the frequency of the bioelectromagnetic field for the method of treating a skin condition may be from about 0.5 Hz to about 20 Hz, or from about 1 Hz to about 20 Hz, from about 5 Hz to about 20 Hz, or from about 8 Hz to about 20 Hz, or from about 10 Hz to about 20 Hz, or from about 0.1 Hz to about 10 Hz, or from about 0.5 Hz to about 10 Hz, or from about 1 Hz to about 10 Hz, or from about 2 Hz to about 10 Hz, or from about 3 Hz to about 10 Hz, or from about 4 Hz to about 10 Hz, or from about 5 Hz to about 10 Hz, or from about 6 Hz to about 10 Hz, or from about 7 Hz to about 10 Hz, or from about 8 Hz to about 10 Hz.
  • the voltage of the bioelectromagnetic field useful for the method of treating a skin condition may be from about 0.1 millivolts (mV) to about 1000 mV, or from about 0.1 millivolts (mV) to about 800 mV, or from about 0.1 millivolts (mV) to about 600 mV, or from about 0.1 millivolts (mV) to about 500 mV, or from about 0.1 millivolts (mV) to about 400 mV, or from about 0.1 millivolts (mV) to about 250 mV, or from about 0.1 millivolts (mV) to about 200 mV, or from about 0.1 millivolts (mV) to about 100 mV, or from about 0.1 millivolts (mV) to about 75 mV from about 0.1 millivolts (mV) to about 50 mV, or from about 0.1 millivolts (mV) to about 25 mV, or from about 0.1 millivolts (mV) to
  • the voltage of the bioelectromagnetic field useful for the method of treating a skin condition may be from about 1 millivolts (mV) to about 1000 mV, or from about 10 millivolts (mV) to about 1000 mV, or from about 50 millivolts (mV) to about 1000 mV, or from about 100 millivolts (mV) to about 1000 mV, or from about 250 millivolts (mV) to about 1000 mV, or from about 500 millivolts (mV) to about 1000 mV, or from about 600 millivolts (mV) to about 1000 mV, or from about 750 millivolts (mV) to about 1000 mV, or from about 800 millivolts (mV) to about 1000 mV.
  • the voltage of the bioelectromagnetic field useful for the method of treating a skin condition may be from about 100 millivolts (mV) to about 750 mV, or from about 250 millivolts (mV) to about 750 mV, or from about 50 millivolts (mV) to about 500 mV, or from about 50 millivolts (mV) to about 250 mV, or from about 10 millivolts (mV) to about 100 mV, or from about 10 millivolts (mV) to about 50 mV, or from about 1 millivolts (mV) to about 100 mV, or from about 1 millivolts (mV) to about 50 mV, or from about 1 millivolts (mV) to about 25 mV.
  • the frequency of the bioelectromagnetic field useful for the method of treating a skin condition is from about 1 Hz to about 10 Hz and the voltage is from about 0.1 mV to about 500 mV.
  • the frequency may be from about 2 Hz to about 7.5 Hz and the voltage is from about 0.1 mV to about 250 mV.
  • the frequency may be from about 0.5 Hz to about 4 Hz and the voltage may be from about 50 mV to about 250 mV.
  • the method of treating a skin condition it may be beneficial, prior to bringing the device or composition into proximity or direct contact with the subject, to first determine whether the device or composition has an electrical frequency response of from about 0.01 to about 20 Hz and an electrical voltage response of from about 0.1 mV to about 1000 mV.
  • Proximity may be less than about 10 cm, less than about 5 cm, less than about 3 cm, less than about 2 cm, less than about 1 cm, or less than about 0.5 cm.
  • aspects of the invention also provide methods for treating one or more injuries (e.g., lacerations, braising, soft tissue injuries, bone fractures, burns) and pain (e.g., joint pain, neuromuscular pain, and other forms of pain).
  • Joint or bond pain may include pain in one or more of the following : an anatomical feature, a joint, a bone, a spine or portion thereof (e.g., a foot, an ankle, a hand, a wrist, a knee, an elbow, a hip, a shoulder, a lower back region, an upper back region, a shin, a neck, etc.).
  • compositions of the invention may be used for similar applications in veterinary care for animals such as pets and farm animals.
  • An animal may be a vertebrate, such as a bird, a fish, or a mammal, e.g., a mouse, cat, dog, rat, hamster, cow, pig, horse, goat, sheep, or rabbit.
  • compositions described herein can be included with an implant or other device that is surgically inserted into a body (e.g., a human body).
  • the composition may be coated on the surface of the implant/device or it may be encased within the body of the device or within one or more containers that are inserted into the body in proximity to the implant or device.
  • compositions of the invention may be used with implants for joint repair, non-union fracture repair, etc.
  • analgesic analgesic; anti-hyperplasia; anti-inflammatory; anti-infective; anti-mycotic; antimicrobial; anti-viral ; antineoplastic; anti-proliferative; anti-psoriatic; anti-photo aging; anti-rheumatic; anti-arthritic; wound healing; augmentation of grafts and implants; inclusion in containers to preserve transplant organs; insect bite healing; treatment of warts; treatment of burns; treatment of sun burns; treatment of abrasions; treatment of ulcers; to improve healing of trauma; and/or to improve or treat any other skin condition (e.g., acne, etc.) .
  • Aspects of the invention may be used to treat any other skin condition (e.g., acne, etc.) .
  • aspects of the invention may be used to treat, prevent or reduce a response to an allergen or toxin (e.g., after exposure to animal hair or dander, pollen, animal venom, plant or animal toxin, poison ivy, poison oak etc.).
  • aspects of the invention may be used to treat pain or discomfort associated with a disease or condition (e.g., cancer, inflammation, tissue degeneration, injuries, fractures, arthritis, rheumatoid arthritis, osteoarthritis, a degenerative etiology of pain, a discogenic disease, etc.).
  • aspects of the invention may be used to provide analgesic relief for one or more conditions.
  • analgesic relief may be provided for Osgood Schlatter's Disease, Patella-Ferneral syndrome, and/or Chondromalacia.
  • compositions and devices of the invention may be used to relieve pain associated with growth (e.g., in children) or associated with tissue degeneration (e.g., associated with aging).
  • compositions and devices of the invention may be used to treat regular pain (e.g., pain associated with menstrual cramps), seasonal pain or inflammation or irritation, or sporadic pain or inflammation or irritation.
  • compositions or devices described herein can be used to improve the focus or increase the alertness of a subject. Accordingly, compositions or devices described herein can be used to treat, reduce, or prevent the effects of sleep deprivation. In some aspects, compositions or devices described herein are useful to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD) or other conditions associated with reduced attention, over-activity, impulsivity, or a combination thereof. In some aspects, compositions or devices described herein can be used to treat sleep disorders, e.g., to improve sleeping patterns. In some aspects, compositions or devices described herein can be used to treat mood disorders. In some aspects, compositions or devices described herein can be used as sexual enhancement products (e.g., to increase sensation, to increase libido and/or sex drive, and/or to increase arousal and/or arousal potential).
  • sexual enhancement products e.g., to increase sensation, to increase libido and/or sex drive, and/or to increase arousal
  • compositions or devices described herein can be used to treat, prevent, or reduce one or more symptoms of a hangover (veisalgia) associated with alcohol-consumption, for example, headache, nausea, vomiting, irritation, tremor, thirst, dryness of mouth, event recall, discomfort, restlessness, impatience, or a combination thereof.
  • a patch or other configuration can be applied to a subjects skin (for example on the forehead or neck) in order to prevent one or more symptoms of veisalgia.
  • a patch or other configuration can be used prior to or after alcohol consumption.
  • compositions or devices described herein also can be used to treat one or more of these symptoms associated with other conditions (non-alcohol related conditions) including vertigo, motion sickness, or other conditions that can cause one or more of these symptoms in a subject.
  • the elemental metal composition may be used in a different suitable configuration (e.g., paste, cream or ointment, layered configuration, container, sheath, patch, etc.).
  • a composition e.g., a composition enclosed in a container
  • the amount of composition that is applied may be tailored to a particular application.
  • a composition in a cream (or past or ointment) form may be applied in a sufficient amount to cover an affected area of skin or an area covering a joint or other bone or body part that is in need of treatment. If the composition is enclosed in a container, a sufficient amount should be used so that the effects of the material can reach to the desired area of treatment.
  • the amount of material may, in part, be determined by the size of the enclosure. Accordingly, different amounts of material may be used (e.g., from several grams to several kilograms, for example, about 5g, lOg, 20g, 30g, 40g, 50g, lOOg, 250g, 500g, or 750g). However, smaller or larger amounts may be used.
  • the duration of exposure may be tailored to a particular application and also may be determined by the user. For example, if a desired result is obtained (e.g., pain relief) a subject may discontinue use.
  • a subject may be exposed on a regular basis (e.g., every day, once a week, etc.) to a suitable composition.
  • a subject may be exposed at night.
  • a suitable composition may be applied at night or incorporated into a bedding material (e.g., a pillow, blanket, mattress, other suitable enclosure, an animal bedding material, etc.).
  • a subject may be exposed during the day.
  • a suitable composition may be included in clothing material (e.g., pants, shirts, skirts, coats, gloves, hats, shoes, socks, etc.).
  • a composition may be provided in an enclosure that can be attached to, or placed in, an item of clothing (e.g., in a hat, glove, shoe, pocket, etc.).
  • composition of the invention may be included in a bandage (e.g., included in a pad in a bandage such as a band-aid) or other material that is used to wrap or cover a wound or painful area of a body.
  • a composition may be formed into one or more separate shapes that can be inserted into container, a pocket, or sewn into a belt or other support.
  • a belt may include one or more discs of material (e.g., 1- 5, 5-10, or more).
  • An animal surface e.g., skin
  • a composition of the invention directly or indirectly (e.g., in a container or through clothing, bedding, or furniture) for any suitable period of time (e.g., 1-5, 5-10, 10-30, or longer), one or more hours (e.g., 1-5, 5-10, or longer), one or more days (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more), one or more weeks (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more), one or more months (e.g., 1-5, 5-10, or longer) or one or more years (e.g., 1, 2, 3, 4, 5, etc.).
  • an animal may be exposed to an elemental metal material on a regular and/or seasonal basis (e.g., every, spring, summer, fall, winter, or any combination thereof) depending on the application and/or the condition being treated.
  • compositions or devices of the invention may be used to alter one or more aspects of plant physiology (germination, growth, flowering, ripening, decaying, etc.).
  • Compositions of the invention may be used in connection with any plant tissue, including, but not limited to, seeds, roots, branches, fruits, vegetables, etc.
  • a composition of the invention may be applied directly to plant material (e.g., in the form of a cream, oil, or other similar substance).
  • a composition of the invention may be provided in a container or sheath that can be contacted with plant tissue, structure, or cells (e.g., roots, stems, branches, leaves, seeds, flowers, etc.).
  • a composition of the invention may be provided in bags or solid containers that can be included with seeds (e.g., in seed silos, sacs, etc.) in order to enhance germination (e.g., to speed up germination, to increase the percentage of seeds that germinate, etc., or any combination thereof).
  • seeds may be stored with a device of the invention.
  • a device of the invention may be added to seed containers when germination is desired (or for example several weeks prior to germination or before seeds are sowed).
  • seeds may be coated directly with a composition of the invention.
  • a composition of the invention may be used as a seed or soil "amendment.”
  • one or more elemental metals e.g., particulate elemental metals
  • a container or surface e.g., a table
  • Plant material e.g., bulbs, seeds, seedlings, small plants, large plants, vegetables, fruit, etc.
  • Plant material e.g., bulbs, seeds, seedlings, small plants, large plants, vegetables, fruit, etc.
  • a device e.g., a weather resistant device
  • a plant growing inside e.g., in a house or a greenhouse
  • outside e.g., in a garden, field, or forest
  • water e.g., in a tank, pond, lake, river, sea, ocean, etc.
  • an elemental metal composition of the invention may be added, either directly or in a suitable container, to agricultural/horticultural products such as soil (e.g., top-soil), mulch, fertilizer, insect or other pest control compositions, etc.
  • an elemental metal composition of the invention may be applied to the inner surface of a container (e.g., a vial, beaker, vase, vat, silo, etc., or any combination thereof) that will be used to store, germinate, and/or grow seeds and/or other plant material.
  • a formulation of the invention may be included in a seed tray, a growing platform, or other surface or container.
  • a composition of the invention may be covered or contained within a material that does not reduce the electro-negative properties of the material or result in an electropositive environment.
  • plastic e.g., polyethylene and/or
  • polypropylene plastic is not used as a coating or encasing material.
  • a composition for use with a plant may include one or more elemental metals that are plant nutrients (e.g., micro- or macro- nutrients essential for plant growth).
  • plant nutrients e.g., micro- or macro- nutrients essential for plant growth.
  • macronutrients include: N, K, Ca, Mg, P, and S.
  • micronutrients include: CI, Fe, B, Mn, Zn, Cu, Mo, and Ni.
  • aspects of the invention may be used to improve food storage and/or transport; to improve seed and/or grain germination; or to improve fruit, grain and/or seed yield.
  • aspects of the invention may be used in connection with any plant or seed, for example any agricultural plant or seed (e.g., barley, corn, cotton, rice, soy, wheat, lettuce, tomatoes, potatoes, apples, oranges, pairs, bananas, etc.) or any flower plant or seed.
  • any agricultural plant or seed e.g., barley, corn, cotton, rice, soy, wheat, lettuce, tomatoes, potatoes, apples, oranges, pairs, bananas, etc.
  • a seed or plant may be exposed to an elemental metal composition for one or more minutes (e.g., 1-5, 5-10, 10-30, or longer), one or more hours (e.g., 1-5, 5-10, or longer), one or more days (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more), one or more weeks (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more), one or more months (e.g., 1-5, 5- 10, or longer) or one or more years (e.g., 1, 2, 3, 4, 5, etc.).
  • a seed or plant may be exposed to an elemental metal material on a regular and/or seasonal basis (e.g., every, spring, summer, fall, winter, or any combination thereof).
  • suitable amounts of material and/or durations of exposure may be optimized by comparing results for animals or plants exposed to different amounts (e.g., including a placebo control), and/or durations of one or more different types of elemental metal compositions with or without containers (e.g., using one or more different types of containers).
  • the effectiveness of an exposure may be evaluated statistically.
  • an exposure of the invention e.g., a combination of type and amount of material, container, and/or duration or exposure
  • the effectiveness of a therapeutic composition may be evaluated in a double-blind placebo-controlled trial.
  • the effectiveness to treat pain or inflammation may be evaluated by obtaining average patient reports (e.g., using a pain scale, for example a 0-10 Lickert type scale) relative to a control on a daily, weekly, monthly, or other time-dependent basis and evaluating them using one or more statistical tests.
  • a patient quality of life score e.g., related to activity and/or mobility
  • the average amount of medication used over a certain time period e.g., a week, a month, or longer
  • a treatment is effective.
  • composition of the invention may be combined with one or more other compositions or preparations that are used to treat or enhance an animal or plant biological process.
  • a composition of the invention may be sterilized.
  • a composition may be prepared from sterile materials.
  • a composition may be sterilized after preparation or during preparation (e.g., by heating, irradiation, etc.).
  • compositions of the invention may have a limited period of effectiveness (e.g., a period during which a useful electronegative or electropositive effect is maintained). Accordingly, certain compositions of the invention may be disposable an or rechargeable. For example, an elemental metal composition may be rechargeable as described herein. In some aspects, a container described herein may be refillable (e.g., with freshly produced or recycled elemental metal material).
  • compositions of the invention may be useful to alter growth, differentiation, or other properties of biological materials ex vivo or in vivo (e.g., to enhance plant, animal, or microbial cell growth in vitro, to preserve organs such as organs for transplantation, to preserve plants or plant grafts for transport, etc.).
  • compositions were tested for their effectiveness to treat different conditions, including different sources of pain, inflammation, itching, and acne as shown in Table 1.
  • Compositions were contacted directly to the skin of a subject, or were enclosed within a container (e.g., a wrap) such that the compositions did not contact the skin directly.
  • elemental metals including combinations of one or more of iron, aluminum, copper, zinc, stainless steel, nickel, bronze, silver, gold, cobalt, or selenium, mixed with one or more of bees wax, lanolin, silicone, silicone powder, silicone adhesive, hydrocolloid, PTFE, castor oil, petroleum jelly, candle wax, polyethylene, mineral oil, or sulfur contained within wraps, including fixation devices and belts made from natural fabrics (such as wool, cotton, and silk), synthetic fabrics (such as synthetic polymers and neoprene), and commercial dressings and commercial adhesives shaped to fit the body part being treated. Representative results are shown in Table 1.
  • One or more physical properties of a composition or device described herein can be measured using any suitable method. Measured physical properties can be used to evaluate biological effectiveness and determine which application(s) a composition or device may be suited for. In addition, the measured physical properties of a composition or device may be used to determine how to modify a composition to change its physical properties and adapt it for a particular biological application.
  • the disclosure relates to techniques for evaluating or quantifying the electrical properties of a device or composition that is to be used for producing a biological field effect when placed in proximity to (or on) the skin of a subject.
  • a Kolbe Electroscope is negatively charged to a stable midrange.
  • a material to be tested is charged by exposure to a suitable energy source (e.g., by exposure to sunlight, to negative ions from a negative ion generator, to a Van de Graff generator, to a body surface, or to any other suitable energy source).
  • the charged material is then brought within the field of the charged Kolbe electroscope and the response is measured.
  • a negative field response is shown by a drop of the charged electroscope, no response is shown by no change or drop in the charged electroscope, a low response is shown by a small deflecting increase ⁇ 1 segment response, a moderate response is shown by a 1 segment increase in charge, and a high response is shown by a > 1 segment increase.
  • FIGS. 1A-1C can be used.
  • FIG. 1A illustrates a non-limiting embodiment of a circuit that can be used to evaluate (e.g., measure) a phase shift between applied voltage and current flow caused by a composition or device being tested. This can be used to evaluate the energy storage functionality of a composition or device. Phase shifts can be tested at different frequencies such as those described herein.
  • FIG. IB illustrates a non-limiting embodiment of a circuit that can be used to evaluate (e.g., measure) a transient discharge resulting from the storage of electromagnetic energy by a composition or device described herein.
  • FIG. 1C illustrates a non-limiting
  • circuit that can be used to evaluate (e.g., measure) current in a composition or device described herein (e.g., at one or more different frequencies described herein).
  • an exemplary pain relief device includes (i) a body portion including a contact region configured for contacting a subject, and (ii) a monopolar transmitter (which may be, for example, a distinct monopolar transmitter, or part of an integrated monopolar transceiver) including a single electrical pole for providing an electrical signal to the body portion for treatment of the subject (e.g., where the subject may be a human patient, a non- human patient such as a pet or other animal, etc.).
  • a monopolar transmitter which may be, for example, a distinct monopolar transmitter, or part of an integrated monopolar transceiver
  • the contact region of the body portion may be considered to be electrically equivalent to the single pole of the monopolar transmitter.
  • a monopolar transmitter certain elements shall be referred to as a monopolar transmitter; however, it is understood such an element may be a monopolar transmitter, a monopolar transmitter along with a monopolar receiver, or a monopolar transceiver.
  • the body portion may include, and/or be one of, a variety of medical devices.
  • the body portion may be a patch, a sleeve, a garment, etc. Additional exemplary medical devices are described below with respect to FIGS. 5A-5K.
  • the contact region of the body portion may be formed from an electrically conductive material .
  • the body portion of the pain relief device may also be configured to receive electrical signals from the subject (e.g., through the single pole of the monopolar transmitter, where the electrical signals may be provided through a surface electricity at the interface between the monopolar transmitter and the subject).
  • the monopolar transmitter interacts with the subject causing electrical signals to be transferred (i) from the monopolar transmitter to the subject, and/or (ii) from the subject to the monopolar transmitter, in the treatment of the subject.
  • the pain relief device may include a signal generator (e.g., such as a waveform generator), for example, which may be included in a programmable device of the pain relief device.
  • the signal generator may generate the electrical signal (for treating the subject) to have a frequency between, for example: 0.1 Hz and 20 Hz; 0.1 Hz and 10 Hz; and 0.1 Hz and 5 Hz.
  • the signal generator may generate the electrical signal (for treating the subject) to have a voltage between, for example: 0.1 volts and 10 volts; 0.1 volts and 5 volts; and 0.1 volts and 1 volt.
  • the pain relief device may include a programmable device.
  • a programmable device may include computer program instructions for providing treatment options for use by the subject.
  • the treatment options may be customized based on patient criteria of the subject. Examples of such patient criteria include at least one of an age of the subject, a gender of the subject, and feedback from the subject regarding prior treatment.
  • the electrical signals transmitted from the pain relief device to the subject utilize the single electrical pole of the monopolar transmitter to interact with the subject.
  • the single electrical pole of the monopolar transmitter may be considered a form of antenna.
  • the second electrical "pole” may be insulated from the subject such that the electrical circuit between the subject may include a path through the "air", or "ground”, or "earth”.
  • the monopolar transmitter (which may include a receiver, and/or which may be a transceiver) may be used to measure waveforms/electrical signals on the surface of the human body.
  • waveforms/signals may be naturally occurring on the surface of the human body.
  • waveforms/signals may be in response to treatment (e.g., from the monopolar transmitter).
  • Such waveforms/signals may be associated with pain, or may not be associated with pain.
  • the waveforms/signals may be acquired (e.g., using a data acquisition function) where the waveforms/signals may be analyzed, processed, and/or reformulated to determine a treatment to be applied to the subject, among other functions.
  • aspects of the invention involve a mass data acquisition process that may have wide implications to the study of energy medicine to many pathologies in addition to the application and treatment of pain (analgesia).
  • a subject 100 e.g., a human patient
  • a pain relief device 102 for treatment of a site of discomfort 100a (e.g., an injured elbow). That is, in FIG. 3A, pain relief device 102 is a form of medical patch/pad secured to the elbow of subject 100 (in this example, the site of discomfort 100a is the elbow).
  • FIG. 3B is a closer view of pain relief device 102 secured to site 100a through contact region 102b of pain relief device 102. Electrical signals
  • FIG. 3C is a block diagram of an exemplary pain relief device 102 including body portion 102a.
  • pain relief device 102 as shown in FIG. 3C, has a simplistic shape for ease of illustration; however, pain relief device 102 may have any shape desired for the given application (e.g., a patch as shown in FIGS. 3A-3B, any of the shapes of the devices 502a-502k shown in FIGS. 5A-5K, among others).
  • pain relief device 102 includes contact portion 102b.
  • contact portion 102b is adjacent monopolar transmitter 102c including a single pole (which may also include a receiver for receiving electrical signals, and/or may be a monopolar transceiver 102c).
  • Exemplary pain relief device 102 also includes a programmable device 102d and a power source 102e (e.g., a battery).
  • Power source 102e provides electrical power for the various elements of programmable device 102d including waveform generator 102dl, waveform analyzer 102d2 (e.g., providing a spectrum analyzer function, such as through the use of an oscilloscope), communication device 102d3, controller 102d4, and memory 102d5.
  • Programmable device 102d e.g., through controller 102d4 and/or memory 102d5 includes computer program instructions for providing treatment options for use by subject 100. An exemplary operation of the elements of programmable device 102d will now be described.
  • Controller 102d4 has access to treatment instructions for subject 100.
  • the treatment instructions may be stored in memory 102d5, and the treatment instructions may be accessed by controller 102d4.
  • the treatment instructions may be provided via communication device 102d3 in communication with a user device (e.g., a bluetooth device, such as a smart phone or other device, etc.).
  • the treatment instructions may be determined by controller 102d4, for example, using data from waveform analyzer 102d2. Further still, combinations of these examples are contemplated (e.g., where initial treatment instructions may be provided via a user device, and then may be updated using the data from waveform analyzer 102d2.
  • controller 102d4 controls waveform generator 102d l to provide electrical signals to monopolar transmitter 102c for transmission of electrical signals to subject 100 (e.g., for treatment of subject 100).
  • Signals from monopolar transmitter 102c e.g., where such signals may represent a status/characteristic of subject 100 wearing pain relief device 102
  • waveform analyzer 102d2 e.g., where output signals from waveform analyzer 102d2 (related to the signals from monopolar transmitter 102c) are provided to at least one of controller 102d4 and memory 102d5 (where memory 102d5 may store information from waveform analyzer 102d2 for later analysis and treatment determination).
  • Such signals from waveform analyzer 102d2 may be used by controller 102d4 in determining a present, or future, treatment to be provided to the subject. That is, controller 102d4 may be used to provide treatment signals through waveform generator 102dl in a closed loop manner, with an input to the closed loop being data/measurements collected from the subject using waveform analyzer 102d2. Specifically, waveform analyzer 102d2 and controller 102d4 may be used in a closed loop manner to efficiently provide pain relief (e.g., maximized pain relief) in real time by measuring the subject steady state and response to treatment.
  • pain relief e.g., maximized pain relief
  • FIG. 4A illustrates subject 100 holding a personal electronic device 300 (e.g., sometimes referred to as a user device, with exemplary user devices being a cell phone, a smart phone, a tablet, etc.).
  • User device 300 may be used (e.g., by subject 100) in communication with pain relief device 102.
  • user device 300 may be bluetooth enabled, and may communicate with pain relief device 102 via communication device 102d3 of programmable device 102d.
  • Bluetooth communication is just one exemplary method of communication between user device 300 and communication device 102d3. Other wired, and/or wireless, communication methods are contemplated.
  • FIG. 4B illustrates user device 300 with a user interface of an exemplary software treatment application shown on the screen of user device 300.
  • the user interface in FIG. 4B illustrates a series of body parts which may now (or in the future) experience discomfort, such that subject 100 (or another person, such as a medical professional) may select the "tab" corresponding to the appropriate body part (e.g., elbow, knee, neck, wrist, etc.).
  • the user may (i) enter pain information about the body part, (ii) review the treatment history associated with the body part, and/or (iii) review treatment options for the body part.
  • the user may also review/edit the patient information (e.g., age, gender, medical details, family history, etc.), and/or may communicate with a medical professional, etc.
  • patient information e.g., age, gender, medical details, family history, etc.
  • other functions may be available to a user of user device 300 in connection with other functions.
  • FIGS. 3A-3C and FIGS. 4A-4B may take any of a number of shapes/configurations, depending on the treatment to be provided to the subject.
  • FIG. 3A and 4A illustrate pain relief device 102 secured to the elbow of subject 100, where pain relief device 102 has the shape/ configuration of a patch/medical pad.
  • FIGS. 5A-5K illustrates various other exemplary pain relief devices 502a-502k which have the same (or substantially the same) functionality as pain relief device 102 described herein. That is, each of devices 502a-502k may include the elements shown in pain relief device 102 shown in FIG. 3C, or different elements within the scope of the invention.
  • FIG. 3C illustrates various other exemplary pain relief devices 502a-502k which have the same (or substantially the same) functionality as pain relief device 102 described herein. That is, each of devices 502a-502k may include the elements shown in pain relief device 102 shown in FIG. 3C, or different elements within the scope of the invention.
  • FIG. 5A illustrates pain relief device 502a having a sleeve shape for treating an elbow
  • FIG. 5B illustrates pain relief device 502b having a sleeve shape (such as a wrist guard or wrist wrap) for treating a wrist
  • FIG. 5C illustrates pain relief device 502c having a sleeve shape (such as a knee brace) for treating a knee
  • FIG. 5D illustrates pain relief device 502d having a sleeve shape for treating an foot (e.g., the arch of a foot)
  • FIG. 5E illustrates pain relief device 502e having a sleeve shape for treating a calf
  • FIG. 5F illustrates pain relief device 502f having a sleeve shape for treating a upper leg (e.g., a thigh of a human subject);
  • FIG. 5G illustrates pain relief device 502g having a sleeve shape for treating an ankle;
  • FIG. 5H illustrates pain relief device 502h having a sleeve shape for treating a neck;
  • FIG. 51 illustrates pain relief device 502i having a glove shape for treating a hand/wrist;
  • FIG. 5J illustrates pain relief device 502j having a skull cap shape for treating a head; and
  • FIG. 5K illustrates pain relief device 502k having a sleeve shape for treating a
  • FIGS. 6-7 are flow diagrams illustrating methods in accordance with the invention. As is understood by those skilled in the art, certain steps included in the flow diagrams may be omitted; certain additional steps may be added; and the order of the steps may be altered from the order illustrated. [00221] Referring specifically to FIG. 6, a method of determining a medical treatment for a subject is provided. At Step 600, a plurality of test recipes are applied to a plurality of subjects (e.g., human subjects, other animal subjects, etc.) to obtain test data. At Step 602, the test data from the plurality of test recipes is analyzed to formulate treatment options for application to a subject.
  • a plurality of test recipes are applied to a plurality of subjects (e.g., human subjects, other animal subjects, etc.) to obtain test data.
  • the test data from the plurality of test recipes is analyzed to formulate treatment options for application to a subject.
  • a device e.g ., a pain relief device such as pain relief devices 102 and 502a-502k illustrated and described herein
  • a treatment option is selected for a patient based on patient criteria. Examples of such patient criteria include at least one of an age of the subject, a gender of the subject, and feedback from the subject regarding prior treatment. Such patient criteria may be made accessible to an algorithm running on the pain relief device (e.g., using user device 300 in communication with the pain relief device).
  • a method of applying a medical treatment to a subject is provided.
  • a treatment is applied to a subject based on a selected treatment option using a programmable pain relief device (e.g., pain relief device 102 including programmable device 102d).
  • the treatment option may have been selected by: a subject (e.g., a human patient); a medical professional on behalf of the patient; or a third party.
  • the pain relief device may have been initially configured with the selected treatment option.
  • the subject or the medical professional or the third party
  • may communicate with the pain relief device e.g., using a user device, such as user device 300 to select the treatment option.
  • a condition of the subject is analyzed through measurements taken using the programmable pain relief device.
  • measurements may be taken using waveform analyzer 102d2 (e.g., receiving signals from monopolar transmitter 102c), where the measurements may be analyzed using controller 102d4 and/or memory 102d5.
  • the treatment is adjusted by the programmable pain relief device based on the results of Step 704. That is, after measurements are taken (and analyzed at Step 704), it may be determined that the treatment applied in Step 700 may need to be adjusted.
  • Steps 702-704 are repeated, as desired in the given application (e.g., at a selected interval, at a predetermined interval, etc.).
  • Providing a pain relief device including a monopolar transmitter (having a single electrical pole) for passing electrical signals to a subject has broad applicability beyond the examples described herein.
  • a user device to communicate with the pain relief device e.g., using bluetooth communication
  • to apply, or adjust, treatment options for a subject also has broad applicability beyond the examples described herein.

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Abstract

L'invention concerne un dispositif de soulagement de la douleur. Le dispositif de soulagement de la douleur comprend : (i) une partie corps comprenant une région de contact configurée pour entrer en contact avec un sujet ; et (ii) un émetteur monopolaire comprenant un seul pôle électrique pour fournir un signal électrique à la partie corps pour le traitement du sujet.
PCT/US2018/054190 2017-10-04 2018-10-03 Champs bioélectromagnétiques thérapeutiques, dispositifs de soulagement de la douleur et procédés associés Ceased WO2019070871A1 (fr)

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US15/724,347 US10905894B2 (en) 2013-03-15 2017-10-04 Therapeutic bioelectromagnetic fields, pain relief devices, and related methods

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070123952A1 (en) * 2004-02-12 2007-05-31 Ndi Medical, Llc Portable assemblies, systems, and methods for providing functional or therapeutic neurostimulation
US20140142654A1 (en) * 2009-03-20 2014-05-22 ElectroCore, LLC. Medical self-treatment using non-invasive vagus nerve stimulation
US20140275717A1 (en) * 2013-03-15 2014-09-18 Prezacor, Inc. Therapeutic bioelectromagnetic fields

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070123952A1 (en) * 2004-02-12 2007-05-31 Ndi Medical, Llc Portable assemblies, systems, and methods for providing functional or therapeutic neurostimulation
US20140142654A1 (en) * 2009-03-20 2014-05-22 ElectroCore, LLC. Medical self-treatment using non-invasive vagus nerve stimulation
US20140275717A1 (en) * 2013-03-15 2014-09-18 Prezacor, Inc. Therapeutic bioelectromagnetic fields

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