Systems and methods of treating medical conditions using arrays of planar coils configured to generate pulsed electromagnetic fields and integrated into clothing

Information

  • Patent Grant
  • 11517760
  • Patent Number
    11,517,760
  • Date Filed
    Tuesday, May 5, 2020
    3 years ago
  • Date Issued
    Tuesday, December 6, 2022
    a year ago
Abstract
The present specification discloses a pulsed electromagnetic field system having planar microcoil arrays integrated into clothing. Each of the planar microcoil arrays has two or more planar microcoils positioned on a flexible substrate. The planar microcoil arrays are connected to a controller configured to generate an electrical current and transmit that electrical current, in accordance with a particular stimulation protocol, to each of the planar microcoil arrays.
Description
FIELD OF THE INVENTION

The present invention is directed toward treating certain medical conditions using planar coils. More specifically, the present invention is directed toward the design, creation and use of clothing products, and other devices, that integrate configurations of arrays of planar coils to generate pulsed electromagnetic fields to treat various medical conditions, such as peripheral or diabetic neuropathies, damaged nerves, wounds, the effects of Parkinson's disease, neurodegenerative disorders, arthritis, cancer, wrinkles, and degenerated musculoskeletal tissues such as cartilage, bone, tendon and ligament.


BACKGROUND OF THE INVENTION

Chronic pain affects more than 100 million people in the US. The most common underlying biological causes for chronic pain include decreased blood circulation, damaged nerves, and/or increased inflammation. While opioids have been a widely used way of alleviating chronic pain, the medical community now recognizes the substantial disadvantages of prescribing opioids. According to the National Institute of Health, more than 130 people in the United States die every day after overdosing on opioids, 21 to 29 percent of patients prescribed opioids for pain misuse them, and between 8 and 12 percent develop an opioid use disorder. The Centers for Disease Control and Prevention estimates that the total economic burden of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement. Therefore, the search is on for a better way to treat pain without relying on highly addictive drugs.


One conventional approach to treating pain is applying pulsing, low frequency electromagnetic fields (PEMF), non-invasively, to the area of the patient's skin where the patient is feeling pain. PEMF therapy uses bursts of low-level electromagnetic radiation to heal damaged tissues and bone and to relieve injury-related pain. The idea is that, when low frequency pulses pass through the skin and penetrate into muscle, nerves, bone and/or tendons, the body's natural repair mechanisms are activated, possibly by normalizing electrical charge distribution in cells, increasing blood perfusion in the affected areas, or improving signaling and/or conduction in nerves.


PEMF therapy has been shown to be effective in regenerating nerves, treating back pain, improving wound healing, countering the effects of Parkinson's disease, and treating peripheral neuropathy, using magnetic fields ranging from picoTesla to Tesla levels. PEMF is a recognized therapy for treating pseudoarthrosis, diabetes mellitus induced complications, delayed wound healing, pain and neurodegenerative disorders and arthritis, and for regenerating musculoskeletal tissues such as cartilage, bone, tendon and ligaments.


Conventionally, PEMF therapy is delivered by a mat, ring or a small disc device that generates a pulsing electromagnetic field using large cylindrically shaped, non-planar coils, such as Helmholtz coils or butterfly coils, where the winding or turns of the coils extend outward from the surface of the first coil in a Z axis. There are numerous disadvantages with these conventional devices. First, they are difficult to use for long periods of time because they require patients to either lay on a mat or strap a special bulky device to their body. Therefore, patient compliance is low and extended treatment periods, such as one or more hours, tends to be unrealistic for most active patients.


Second, they generate highly localized magnetic fields which tend to only over a small portion of the body or are substantially non-homogenous across their surface areas. As a result, the surface areas of the devices have regions with very low, non-therapeutic magnetic field dose levels interspersed with regions with sufficiently high, therapeutic doses of magnetic fields. Patients, however, are unaware of what surface areas emit therapeutic doses and what surface areas emit non-therapeutic doses, resulting in suboptimal therapy. For example, a patient with a need for PEMF therapy in his or her feet may lay on a mat in a way that the feet are not sufficiently exposed to the requisite magnetic field dose levels.


Third, for patients with extensive peripheral neuropathies, it is very difficult to get all over body PEMF therapy in an efficient manner. For example, a patient with pain all around his or her torso would have to lay on a mat in the right alignment with the surface areas emitting the right therapeutic doses, assuming such areas can be identified, for at least a period of time ranging from 20 minutes to 3 hours and then have to flip over and repeat the process. Again, this is highly inefficient for active patients.


Fourth, these devices are not specifically designed to treat, or be applied to, specific parts of the body. As such, they often fail to conform to particular body parts, are difficult to position or wear for long periods of time and are to use consistently.


Fifth, commercial PEMF devices, designed for at home use, to treat anxiety disorders, obsessive compulsive disorder, post-traumatic stress disorder, memory degeneration, schizophrenia, Parkinson's disease, stroke rehabilitation, drug addiction, including addiction to, or cravings for, nicotine, cocaine, alcohol, heroine, methamphetamines, stimulants, and/or sedatives, depression and depression-related conditions, such as post-partum depression or bipolar depression, auditory hallucinations, multiple sclerosis, fibromyalgia, Alzheimer's disease, spinocerebellar degeneration, epilepsy, urinary incontinence, movement disorders, chronic tinnitus, and sleep apnea are simply not available and have generally been deemed to be untreatable using PEMF devices.


It is therefore desirable to have a pulse electromagnetic field device that can generate substantially homogenous magnetic fields across large surface areas. It is further desirable to have a pulse electromagnetic field device that can be comfortably worn for long periods of time, thereby increasing patient compliance and allowing active patients to get the necessary treatment. It would also be desirable to have a pulse electromagnetic field device where the therapeutically effective dose regions are known and/or predictable. Finally, it would also be desirable to have a pulse electromagnetic field device designed to treat a wide range of disorders, particularly disorders with a locus of dysfunction in the brain.


SUMMARY OF THE INVENTION

The present specification discloses a pulsed electromagnetic field device comprising: an article of clothing; a controller removably attachable to the article of clothing; and a plurality of planar microcoil arrays, wherein each of the plurality of planar microcoil arrays comprises two or more planar microcoils positioned on a flexible substrate, wherein each of the plurality of planar microcoil arrays is integrated into the article of clothing; and wherein each of the plurality of planar microcoil arrays is in electrical communication with the controller.


Optionally, the pulsed electromagnetic field device further comprises a docking station, wherein the docking station is configured to releasably receive the controller. Optionally, the docking station comprises a first mechanical connector and a first electrical interface, wherein the controller comprises a second mechanical connector and a second electrical interface, and wherein, upon the first mechanical connector and the second mechanical connector latching, the first electrical interface is automatically placed in electrical communication with the second electrical interface.


Optionally, the article of clothing comprises two or more layers of material and the plurality of planar microcoil arrays is positioned between the two or more layers of material.


Optionally, the article of clothing is at least one of a sock, a shoe, a shirt, a pant, a glove, a mask, a neck covering, a head covering, a headband, a sleeve, or a brace configured to fit over an elbow, an ankle, or a knee.


Optionally, the controller is configured to generate a pulse train, wherein each pulse train comprises a plurality of pulses having an amplitude in a range of 1 mA to 200 mA. Optionally, the pulse train comprises a first pulse having a first amplitude, a second pulse having a second amplitude, and a third pulse having a third amplitude, wherein the first amplitude is less than the second amplitude and the second amplitude is less than the third amplitude. Each of the first pulse, second pulse, and third pulse may have a square shape. Each of the two or more planar microcoils may be configured to generate a magnetic field in a range of 1 microTesla to 100 microTesla upon receiving the pulse train.


Optionally, each of the plurality of planar microcoil arrays comprises at least six planar microcoils. Each of the plurality of planar microcoil arrays may comprise an input terminal configured to receive current from the controller, an output terminal, and at least two traces to electrically connect each of the at least six planar microcoils to the input terminal and the output terminal. Optionally, a first set of the at least six planar microcoils is configured to direct current clockwise and a second set of the at least six planar microcoils is configured to direct current counterclockwise. Optionally, the first set of the at least six planar microcoils is less than the second set of the at least six planar microcoils. Optionally, the first set of the at least six planar microcoils is equal to the second set of the at least six planar microcoils. All of the at least six planar microcoils may be configured to direct current in a same direction.


Optionally, each of the two or more planar microcoils is at least one of a spiral circular planar microcoil, a rectangular circular planar microcoil, a non-spiral circular planar microcoil, or a non-spiral rectangular planar microcoil.


Optionally, each of the plurality of planar microcoil arrays is physically separate and a first subset of the plurality of planar microcoil arrays has a different surface area than a second subset of the plurality of planar microcoil arrays.


Optionally, each of the plurality of planar microcoil arrays is physically separate and has a same surface area.


The controller may be configured to generate a time varying current in order to create a time varying magnetic field at each of the plurality of planar microcoil arrays. Optionally, the time varying current is defined by square waves having substantially equal peak amplitude values. Optionally, the time varying current is defined by sinusoidal waves having substantially equal peak amplitude values. Optionally, the time varying current is defined by square waves having substantially different peak amplitude values. Optionally, the time varying current is defined by a train of square waves wherein, in each train, the square waves have peak values that ramp from a low peak amplitude value to a higher peak amplitude value.


The controller may be configured to cause an electrical current to be concurrently transmitted to all of the plurality of planar microcoil arrays.


The controller may be configured to cause an electrical current to be transmitted to all of the plurality of planar microcoil arrays at different times.


Optionally, the pulsed electromagnetic field device further comprises a set of programmatic instructions stored on a separate computing device, wherein, when executed by the separate computing device, the programmatic instructions generate a display for prompting a user to input a pain level and a locus of pain. Optionally, when executed by the separate computing device, the programmatic instructions determine which of the plurality of planar microcoil arrays should receive an electrical current based on at least one of the pain level or the locus of pain.


Optionally, when executed by the separate computing device, the programmatic instructions generate data indicative of which of the plurality of planar microcoil arrays should receive an electrical current based on at least one of the pain level or the locus of pain and transmit the data to the controller. Optionally, the controller generates an electrical current based on the data and in a predefined pattern based on at least one of the pain level or the locus of pain.


Optionally, the pulsed electromagnetic field device further comprises a plurality of traces integrated into the article of clothing and extending from each of the plurality of planar microcoil arrays to the controller.


The present specification also discloses a method of treating a condition, comprising: attaching an article of clothing to a portion of a patient's body, wherein the article of clothing comprises a plurality of planar microcoil arrays, wherein each of the plurality of planar microcoil arrays comprises two or more planar microcoils positioned on a flexible substrate, wherein each of the plurality of planar microcoil arrays is integrated into the article of clothing; and wherein each of the plurality of planar microcoil arrays is in electrical communication with a docking station integrated into the article of clothing; attaching a controller to the docking station, wherein the controller comprises a circuit and a power source; and activating the controller to cause a time varying current to be transmitted to each of the plurality of planar microcoil arrays.


The method condition may be at least one of an anxiety disorder, an obsessive compulsive disorder, a post-traumatic stress disorder, memory degeneration, schizophrenia, Parkinson's disease, stroke rehabilitation, drug addiction, drug cravings, depression, depression-related conditions, post-partum depression, bipolar depression, auditory hallucinations, multiple sclerosis, fibromyalgia, Alzheimer's disease, spinocerebellar degeneration, epilepsy, urinary incontinence, movement disorders, chronic tinnitus, or sleep apnea.


Optionally, the method further comprises attaching the article of clothing such that at least one of the two or more planar microcoils in at least one of the plurality of planar microcoil arrays is positioned over an acupoint of the patient's body.


Optionally, upon attaching the controller to the docking station, the circuit automatically electrically interfaces with at least one of the plurality of planar microcoil arrays.


The present specification also discloses a pulsed electromagnetic field system comprising: a plurality of planar microcoil arrays, wherein each of the plurality of planar microcoil arrays comprises two or more planar microcoils positioned on a flexible substrate and wherein one of the plurality of planar microcoil arrays is connected to another of the plurality of planar microcoil arrays; and a controller configured to generate an electrical current and transmit that electrical current, in accordance with a particular stimulation protocol, to each of the plurality of planar microcoil arrays.


Optionally, the planar microcoil is at least one of a spiral circular planar microcoil, a rectangular circular planar microcoil, a non-spiral circular planar microcoil, or a non-spiral rectangular planar microcoil.


Optionally, a first subset of the plurality of planar microcoil arrays has a different surface area than a second subset of the plurality of planar microcoil arrays.


Optionally, each of the plurality of planar microcoil arrays has a same surface area.


Optionally, the stimulation protocol comprises a time varying magnetic field. Optionally, the time varying magnetic field is defined by square waves having substantially equal peak values. Optionally, the time varying magnetic field is defined by a sinusoidal wave. Optionally, the time varying magnetic field is defined by square waves having different peak values. Optionally, the time varying magnetic field is defined by a train of square waves wherein, in each train, the square waves have peak values that ramp from a low peak value to a higher peak value.


Optionally, the controller is configured to cause an electrical current to be transmitted substantially currently to all of the plurality of planar microcoil arrays.


Optionally, the controller is configured to cause an electrical current to be transmitted to the plurality of planar microcoil arrays at different times.


Optionally, the pulsed electromagnetic field system further comprises a set of programmatic instructions stored on a separate computing device, wherein, when executed by the separate computing device, the programmatic instructions generate a display for prompting a user to input a pain level and a locus of pain. Optionally, when executed by the separate computing device, the programmatic instructions determine which of the plurality of planar microcoil arrays should receive an electrical current based on the pain level and/or locus of pain. Optionally, when executed by the separate computing device, the programmatic instructions generate data indicative of which of the plurality of planar microcoil arrays should receive an electrical current based on the pain level and/or locus of pain and transmit said data to the controller. Optionally, the controller generates an electrical current based on said data and in a predefined pattern based on the pain level and/or locus of pain.


The present specification also discloses a sock, shirt, pant, glove, head covering, head band, helmet, mask, neck covering, sleeve, and garment comprising the pulsed electromagnetic field system described above.


The aforementioned and other embodiments of the present specification shall be described in greater depth in the drawings and detailed description provided below.





BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present specification will be further appreciated, as they become better understood by reference to the following detailed description when considered in connection with the accompanying drawings:



FIG. 1A depicts an exemplary planar microcoil in a first circular configuration;



FIG. 1B depicts an exemplary planar microcoil in a first rectangular configuration;



FIG. 2A depicts an exemplary planar microcoil in a second circular configuration;



FIG. 2B depicts an exemplary planar microcoil in a second rectangular configuration;



FIG. 3A depicts an exemplary planar microcoil in a third circular configuration;



FIG. 3B depicts an exemplary planar microcoil in a third rectangular configuration;



FIG. 3C depicts an exemplary planar microcoil in a fourth configuration;



FIG. 4A depicts an exemplary planar microcoil in a first alternative configuration;



FIG. 4B depicts an exemplary planar microcoil in a second alternative configuration;



FIG. 4C depicts an exemplary planar microcoil in a third alternative configuration;



FIG. 5A depicts a first exemplary set of dimensions associated with an exemplary rectangular planar microcoil;



FIG. 5B depicts a second exemplary set of dimensions associated with an exemplary rectangular planar microcoil;



FIG. 6 depicts an exemplary planar microcoil system with multiple arrays of microcoils;



FIG. 7A depicts an exemplary planar microcoil positioned on a substrate;



FIG. 7B depicts an exemplary set of planar microcoils positioned on a substrate;



FIG. 8 depicts exemplary planar microcoils positioned on a second substrate;



FIG. 9 depicts an exemplary planar microcoil circuit diagram;



FIG. 10A depicts a first pulsed electromagnetic frequency signal which may be implemented to administer the therapies described herein;



FIG. 10B depicts a second pulsed electromagnetic frequency signal which may be implemented to administer the therapies described herein;



FIG. 10C depicts a third pulsed electromagnetic frequency signal which may be implemented to administer the therapies described herein;



FIG. 10D depicts a fourth pulsed electromagnetic frequency signal which may be implemented to administer the therapies described herein;



FIG. 10E depicts a fifth pulsed electromagnetic frequency signal which may be implemented to administer the therapies described herein;



FIG. 10F depicts a sixth pulsed electromagnetic frequency signal which may be implemented to administer the therapies described herein;



FIG. 10G depicts a seventh pulsed electromagnetic frequency signal which may be implemented to administer the therapies described herein;



FIG. 11A depicts a shirt with embedded planar microcoil arrays, in accordance with some embodiments of the present specification;



FIG. 11B depicts a pair of socks with embedded planar microcoil arrays, in accordance with some embodiments of the present specification;



FIG. 11C depicts a head covering with embedded planar microcoil arrays, in accordance with some embodiments of the present specification;



FIG. 11D depicts a pair of pants or leggings with embedded planar microcoil arrays, in accordance with some embodiments of the present specification;



FIG. 11E depicts a glove with embedded planar microcoil arrays, in accordance with some embodiments of the present specification;



FIG. 12A depicts a shirt with embedded planar microcoil arrays, in accordance with other embodiments of the present specification;



FIG. 12B depicts a pair of socks with embedded planar microcoil arrays, in accordance with other embodiments of the present specification;



FIG. 12C depicts a head covering with embedded planar microcoil arrays, in accordance with other embodiments of the present specification;



FIG. 12D depicts a pair of pants or leggings with embedded planar microcoil arrays, in accordance with other embodiments of the present specification;



FIG. 12E depicts a glove with embedded planar microcoil arrays, in accordance with other embodiments of the present specification;



FIG. 13 is a flowchart showing an exemplary use of the system;



FIG. 14 is an exemplary footwear system;



FIG. 15 is an exemplary array of planar coils;



FIG. 16 is an exemplary current directionality of a coil array;



FIG. 17 is an exemplary docking station configured to interface with a controller;



FIG. 18 is an exemplary head covering with planar microcoil arrays integrated therein;



FIG. 19 is a side view of an article of clothing with planar microcoil arrays integrated therein; and



FIG. 20 shows an exemplary method of using the PEMF device.





DETAILED DESCRIPTION

The present specification is directed towards multiple embodiments. The following disclosure is provided in order to enable a person having ordinary skill in the art to practice the invention. Language used in this specification should not be interpreted as a general disavowal of any one specific embodiment or used to limit the claims beyond the meaning of the terms used therein. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.


In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated. It should be noted herein that any feature or component described in association with a specific embodiment may be used and implemented with any other embodiment unless clearly indicated otherwise.


As used herein, the indefinite articles “a” and “an” mean “at least one” or “one or more” unless the context clearly dictates otherwise.


As used herein, the term “planar coil” or “planar microcoil” both refer to a conductive pathway with curves or turns where the entirety of the conductive pathway is substantially positioned within the same plane. Stated differently, the turns, curves, or coils of the conductive pathway occupy varied positions within an X-Y plane but are of the same thickness or have a thickness within a range of 20% of each other. Accordingly, such a planar microcoil is differentiated from conventional coil structures because the windings or turns of the coil do not extend substantially upward or outward from the innermost or first coil in the Z direction or normal to the X-Y plane defined by the innermost or first coil. The terms “extend substantially upward or outward”, “within the same plane”, or “within the same X-Y plane” are defined as within +/−20 mm, within +/−15 mm, within +/−10 mm, or more preferably within +/−5 mm of a 0 point on the Z axis. The planar footprint area of a “planar coil” or “planar microcoil” is preferably greater than 1 cm2, more preferably between 1 cm2 and 9 cm2, and even more preferably between 2 cm2 and 4 cm2.


As used herein, the term “magnetic flux” refers to a quantity or strength of magnetic lines produced by a current passing through one or more planar coils and the term “magnetic flux density” refers to the amount of that magnetic flux in an area taken perpendicular to the magnetic flux's direction, typically measured in Tesla. It should be appreciated that, throughout this specification and in each embodiment taught here, all magnetic fields, and corresponding magnetic flux and magnetic flux densities, are generated by a current passing through one or more planar coils and are not generated by one or more permanent magnets unless otherwise stated. It should further be appreciated that each embodiment described herein may further include an optional version which expressly does not include, incorporate, or otherwise use permanent magnets but, yet, which still generate magnetic fields.


Planar Microcoil Structure


Referring to FIGS. 1A, 1B, 2A, and 2B, the planar microcoils may have a plurality of different shapes and dimensions. FIG. 1A shows a spiral circular planar microcoil 100a having six turns where the conductive pathway follows a spiral shape from a first part of the circuit 102a, or where the spiral coil conductive pathway begins, to a second part of the circuit 104a, or where the spiral coil conductive pathway terminates. Each turn forms a circle, except that the beginning and end of the circle are offset from each other, thereby creating a spiral across all turns. The spiral shaped conductive pathway 106a is substantially entirely positioned within the same X-Y plane.


Similarly, FIG. 1B shows a spiral rectangular planar microcoil 100b having 10 turns where the conductive pathway follows a spiral shape from a first part of the circuit 102b, or where the spiral coil conductive pathway begins, to a second part of the circuit 104b, or where the spiral coil conductive pathway terminates. Each turn forms a rectangle, except that the beginning and end of the circle are offset from each other, thereby creating a spiral across all turns. The spiral shaped conductive pathway 106b is substantially entirely positioned within the same X-Y plane.


It should be appreciated that the present invention is directed toward any spiral shaped planar microcoil, including polygonal, elliptical, or other shapes, having a plurality of turns where the conductive pathway follows a spiral shape from a first part of the circuit, or where the spiral coil conductive pathway begins, to a second part of the circuit, or where the spiral coil conductive pathway terminates. In such embodiments, each turn would form the same polygonal, elliptical, or other shape, except that the beginning and end of the shape are offset from each other, thereby creating a spiral across all turns. The spiral shaped conductive pathway would also be substantially entirely positioned within the same X-Y plane.



FIG. 2A shows a non-spiral circular planar microcoil 200a having three turns where the conductive pathway follows a curved, or circular, shape from a first part of the circuit 202a, or where the coil conductive pathway begins, to a second part of the circuit 204a, or where the coil conductive pathway terminates. Each turn forms an incomplete circle and shares a common electrical input and electrical output with the adjacent turns, thereby creating a set of nested incomplete circles, each in electrical communication with a common electrical input 202a and electrical output 204a and each having a progressively smaller (or larger) radius. The conductive pathway of nested incomplete circles 206a is substantially entirely positioned within the same X-Y plane.


Similarly, FIG. 2B shows a non-spiral rectangular planar microcoil 200b having four turns where the conductive pathway follows a polygonal, or rectangular, shape from a first part of the circuit 202b, or where the coil conductive pathway begins, to a second part of the circuit 204b, or where the coil conductive pathway terminates. Each turn forms an incomplete rectangle and shares a common electrical input and electrical output with the adjacent turns, thereby creating a set of nested incomplete rectangles, each in electrical communication with a common electrical input 202b and electrical output 204b and each having a progressively smaller (or larger) length and width. The conductive pathway of nested incomplete rectangles 206b is substantially entirely positioned within the same X-Y plane.


It should be appreciated that the present invention is directed toward any non-spiral shaped planar microcoil, including polygonal, elliptical, or other shapes, having a plurality of turns where the conductive pathway follows a polygonal, elliptical, or other shape from a first part of the circuit, or where the coil conductive pathway begins, to a second part of the circuit, or where the coil conductive pathway terminates. In such embodiments, each turn would form the same incomplete polygonal, elliptical, or other shape and would share a common electrical input and electrical output with the adjacent turns, thereby creating a set of nested incomplete polygonal, elliptical, or other shapes, each in electrical communication with a common electrical input and electrical output and each having a progressively smaller (or larger) length and width or radius. The conductive pathway of nested incomplete polygonal, elliptical, or other shapes would be substantially entirely positioned within the same X-Y plane



FIGS. 3A, 3B, 3C, 4A, 4B, 4C, 5A, 5B, 7A, 7B and 8 show additional exemplary microcoil embodiments and configurations. Referring to FIG. 3A, a circular spiral coil is shown 300a with a current input 305a and current output 310a on the same side and parallel to each other. FIG. 3B shows a rectangular spiral coil 300b with a current input or output 305b in the interior of the coil 300b. FIG. 3C shows a high-density spiral coil with an interior, wireless region 320c that is rectangular with curved corners. FIGS. 4A-4C show less preferred embodiments where 400a shows a two pronged coil with the two parallel ends of the coil separated by an open space 405a, 400b shows a two pronged coil with the two parallel ends of the coil separated by a zig-zag coil 405b, and 400c shows a two pronged coil with the two parallel ends of the coil separated by a zig-zag coil and having a conductive material positioned therein 405c. Referring to FIG. 8, a multi-coil planar array 800 may include two or more pronged coils 810 with the two ends of the coil separated by a zig-zag coil 805.



FIG. 5A shows a side perspective view of a planar coil 500a with coil depth in the Z the direction, as denoted by the variable “h”. The variable D denotes a dimension indicative of the distance from one exterior side of the coil to the opposing exterior side of the coil. The variable b denotes a dimension indicative of the thickness of the coil. The variable p denotes a dimension indicative of the distance between coils, referred to as a pitch. The variable Di denotes a dimension indicative of the distance from one interior side of the innermost coil to the opposing interior side of the innermost coil. Referring to FIG. 5B, the variable g also shows a spacing between coils. The arrow indicates a flow of current from an outside current coil connection to an inside current coil output. Referring to FIG. 7A, a single coil 700a mounted on a substrate 730a, where the coil is rectangular and has an input/output, 720a, 725a, on the exterior of the coil and in the interior of the coil. Referring to FIG. 7B, six coil 700a mounted on a substrate 730a, where the coil is rectangular and has an input/output, 720a, 725a, on the exterior of the coil and in the interior of the coil. FIG. 7B represents the preferred embodiment of a planar multi-coil array 700b and is discussed in greater detail with respect to FIG. 15. Six circular planar coils, 740b, 741b, are mounted on a flexible substrate 730b. Three coils 740b are on a top side and three coils 741b are on a bottom side. All coils are electrically connected, via traces 750b which run across the substrate, and 760b which connect from trace 750b to an individual coil, to a current input 720b and a current output 725b. In one embodiment, the current input 720b and output 725b are on the same side of the substrate 730b. In another embodiment, the current input 720b and output 725b may be on the different sides of the substrate 730b.


Table 1 has a list of preferred attributes of each of the spiral circular coil (FIG. 1A), spiral rectangular coil (FIG. 1B), non-spiral circular coil (FIG. 2A), and non-spiral rectangular coil (FIG. 2B). It should be appreciated that one or more of the other coils, as described herein, may have one or more of the preferred attributes described in Table 1 below.









TABLE 1







Coil Attributes












Spiral
Spiral
Non-spiral
Non-spiral



circular coil
rectangular coil
circular coil
rectangular coil


Variables
FIG. 1a
FIG. 1b
FIG. 2a
FIG. 2b





Width of the coil
1 to 200 microns
1 to 200 microns
1 to 200 microns
1 to 200 microns


segments (note that
(preferably 25 to
(preferably 25
(preferably 25 to
(preferably 25 to 100


the widths may be
100 microns,
to 100 microns,
100 microns,
microns, preferably


constant or
preferably 50
preferably 50
preferably 50
50 microns)


variable)
microns)
microns)
microns)


Distance from
10 to 500
10 to 500
10 to 500 microns
10 to 500 microns


center of coil to
microns
microns
(preferably 100
(preferably 100


innermost coil
(preferably 100
(preferably 100
microns)
microns)


segment
microns)
microns)


Distance from
43 to 800250
43 to 800250
43 to 800250
43 to 800250


center to the
microns, where
microns, where
microns, where
microns, where the


outermost coil
the max distance
the max
the max distance
max distance is


segment
is calculated
distance is
is calculated
calculated using 100



using 100
calculated using
using 100
microns for the width



microns for the
100 microns for
microns for the
of the coil segment,



width of the coil
the width of the
width of the coil
250 microns for the



segment, 250
coil segment,
segment, 250
distance from the



microns for the
250 microns for
microns for the
center of the coil to



distance from the
the distance
distance from the
the innermost coil



center of the coil
from the center
center of the coil
segment, pitch is



to the innermost
of the coil to the
to the innermost
1500 microns,



coil segment,
innermost coil
coil segment,
number of turns is



pitch is 1500
segment, pitch
pitch is 1500
500



microns, number
is 1500
microns, number



of turns is 500
microns,
of turns is 500




number of turns




is 500


Distance between
10 to 3000
10 to 3000
10 to 3000
10 to 3000 microns


each coil segment,
microns
microns
microns
(preferably 50, 200,


referred to as pitch
(preferably 50,
(preferably 50,
(preferably 50,
650, 1150 microns)


(note that the pitch
200, 650, 1150
200, 650, 1150
200, 650, 1150


may be constant or
microns)
microns)
microns)


variable)


Height of the coil
0.1 to 20
0.1 to 20
0.1 to 20 microns
0.1 to 20 microns


segments
microns
microns
(preferably 1
(preferably 1 micron)



(preferably 1
(preferably 1
micron)



micron)
micron)


Number of turns
3 to 500
3 to 500
3 to 500
3 to 500 (preferably


(defined as the
(preferably 5, 20,
(preferably 5,
(preferably 5, 20,
5, 20, 48, 94)


number of times a
48, 94)
20, 48, 94)
48, 94)


coil travels around


the center of the


coil at least 270


degrees)


Support structure
SiO2/Si, wafer,
SiO2/Si, wafer,
SiO2/Si, wafer,
SiO2/Si, wafer,



Kapton, flexible
Kapton, flexible
Kapton, flexible
Kapton, flexible









Referring back to FIG. 3C, in another embodiment, a copper coil 305c that is substantially circular with a substantially rectangular inner air core (having rounded internal edges) is provided. In one embodiment, it has the following attributes:


1. The coil, including any hard-plastic backing, has a footprint no greater than 2 cm by 2 cm, preferably no greater than 1.65 by 1.65 centimeters.


2. The coil comprises a plurality of wire turns, where the diameter of the coil in the plane of the coil is 0.04 mm.


3. The coil will have a minimum of 100 turns, preferably 175 windings, and even more preferably greater than 150 windings.


4. Each corner of the coil will have 1 quarter-circle with a radius of 0.18125 cm.


5. The inductance is in a range of 200 to 700 uH, preferably around 373 uH and the resistance is in a range of 50 to 800 ohms, preferably around 144 ohms.


6. The inner air core has dimensions in a range of 0.2 cm by 0.2 cm with each corner of the inner air core being 1 quarter-circle with a radius of 0.00625 cm.


Planar Microcoil Arrays and Controllers


Referring to FIG. 6, the therapeutic system 600 comprises a flexible patch or substrate 620 having one or more planar microcoils 620 positioned thereon. The flexible patch or substrate 620 comprises a flexible material, such as Kapton, polyimide, or any other suitable non-conductive flexible material. A single patch 620 comprising a plurality of planar microcoils 615 constitutes a planar microcoil array 630, as shown in FIGS. 7b and 15. Each of the arrays is connected in parallel or in series to a controller 605. For example, the set of patches 620 in column 603 may be connected serially, while the patches in columns adjacent to column 603 may be connected in parallel to the patches in column 603 via wires, or electrical communication pathways, 610.


In one embodiment, the single patch 620 comprises two or more planar microcoils 615 or between 2 and 100 microcoils or more than 2 planar microcoils. In one embodiment, the set of patches used in any specific application, including in any piece of clothing, may have different sizes (e.g. surface areas), and therefore different numbers of planar microcoils, in order to better fit or suit different parts of a person's anatomy. For example, clothing positioned adjacent to the patient's torso may have larger patches, and more planar microcoils, integrated into a single patch than clothing positioned near the patient's toes or fingers, which may have smaller patches to better contour to the curves and crevices near the patient's toes or fingers, as further discussed in relation to FIGS. 12a to 12e.


Controller 605 may be programmed to concurrently stimulate all the planar microcoils in all the patches, all planar microcoils on a subset of the patches, or a subset of planar microcoils on a subset of the patches. Further, the controller 605 may be optionally configured to removably interface with a docking station 675. Referring to FIG. 17, a docking system 1700 is comprised of a controller 1705 having circuitry 1710 configured to generate current signals in accordance with the stimulation protocols described herein, a first mechanical connection 1722, and a power source, such as a battery 1720, and a docking station 1730, having an electrical connection 1740 configured to mate to the circuitry 1710 and a second mechanical connection 1745 configured to mate with the first mechanical connection 1722. In one embodiment, the electrical connection 1740 comprises one or more pins having data stored therein indicative of the type of clothing, device, or application the docking station 1730 is integrated into. As described below, the planar microcoil arrays are integrated into clothing and, preferably, the docking station 1730 is as well. The controller 1705 is removably attachable to the docking station 1730 such, upon connecting the first mechanical connection 1722 to the second mechanical connection 1745, the circuit 1710 is automatically placed in electrical communication with, and is therefore capable of driving a current through, electrical interface 1740. Further, upon being automatically interfaced with electrical interface 1740, the circuit 1710 is configured to read the data indicative of the type of clothing or planar array configuration to which the docking station 1730 is connected, thereby allowing a user to use one controller 1705 with multiple different clothing types and further allowing the controller 1705 to be charged or serviced separate from the docking station 1730, planar microcoil arrays, and clothing into which both are integrated. The mechanical connection may be a male/female latch combination, a male/female snap combination, or any other male/female mechanical combination.


In one embodiment, programmatic instructions on a separate computing device, such as a phone, 635, are executed to capture pain data from the patient, analyze the pain data to determine which areas of the patient's anatomy requires pulsed electromagnetic field therapy, and, depending on the garment being worn by the patient, activate one or more planar microcoils on one or more patches to target the determined areas requiring pulsed electromagnetic field therapy.


More specifically, referring to FIG. 13, a patient first acquires a specific piece of clothing with the patches and planar microcoil arrays integrated therein, as further described below. The patient downloads an app onto his or her phone 635, creates an account, and inputs a clothing identifier, using a QR code, RFID tag, serial number or another identifier. In response to inputting the clothing identifier, the app determines the type of clothing (shirt, pant, sock, etc.) and generates a set of clearance questions specific to that type of clothing 1305. Clearance questions may be directed toward making sure the device is not used proximate to implanted devices, metal or other structures that, if positioned on the patient's skin, could experience induced electrical currents if pulsed electromagnetic fields are applied thereto.


After receiving the user's response to the clearance questions, the app determines if there are any contraindications to use (i.e. a pacemaker, spinal implants, pins, or other implanted devices) 1310 and, depending upon the determination, generates an activation code which is transmitted to the controller 605. If the user inputted data is contraindicated for use with the specific piece of clothing, the app recommends the user first activate the device under the supervision of a physician. An override code, which would require the user to actively acknowledge the risks involved, may be provided by the app and either wirelessly transmitted to the controller 605 or displayed to the user who may manually input it into the controller 605.


If user, relative to the identified piece of clothing, is cleared for use and the controller 605 is activated, the app then prompts the user to input data indicative of the patient's pain level and location of the pain 1315. The app may do so by generating a visual analog scale that the user may use to indicate a level of pain being experienced (i.e. on a scale of 1 to 10 or using graphical emojis) and a graphical image of a human body, or portions thereof, to allow the user to identify, by pointing to the right location on the graphical image, the locus of pain. In one embodiment, the graphical image used is specific to the type of clothing identified using the original code indicative of the clothing acquired. Once the degree and/or locus of pain has been identified, the app may determine which set of patches and/or set of planar microcoils should be energized in order to treat the inputted level and location of pain 1320 and transmit such data to the controller. For other conditions, other questions may be posed, such as degree and timing of memory lapses, degree and timing of tremors, or degree and timing of other symptoms.



FIG. 9 describes an exemplary circuit 900 configured to generate electrical currents, in accordance with stimulation protocols described below. The exemplary circuit may be in the controller 605 or distributed between the controller 605 and patches 620.


Referring to FIG. 15, the coil array 1500 may comprise a flexible substrate 1502 upon which a plurality of coil pieces 1504 are attached. Each coil piece 1504 comprises a backing, such as a hard-plastic backing 1506, upon which a coil 1508 is wound or molded. The coils may be any of the rectangular spiral, rectangular non-spiral, circular spiral, circular non-spiral or other shaped coils. The coil pieces 1504 are preferably spaced from each other in a range of 0.1 cm to 10 cm, preferably 0.5 cm to 2 cm, and preferably less than 15 cm, or any numerical increment therein. Each coil 1508 comprises an input lead and an output lead. The input lead of each coil 1508 may be routed to one side of the array 1510 and may be kept separate from each other by one or more layers of insulation tape 1512. The input leads of all the coils 1508 of the array 1500 are integrated or multiplexed together to form an input terminal 1522 to which electrical current from the controller and energy source may be directed. Accordingly, all the coils 1508 of the array 1500 may be concurrently energized by directing current from a single energy or battery source to just one input terminal 1522.


Similarly, the output lead of each coil 1508 may be routed to one side of the array 1514 and may be kept separate from each other by one or more layers of insulation tape 1512. The output leads of all the coils 1508 of the array 1500 are integrated or multiplexed together to form an output terminal 1524 to which electrical current from the controller and energy source may be directed. Accordingly, the output leads of all the coils 1508 of the array 1500 are integrated or multiplexed together to form an output terminal 1524 to which electrical current may be directed from the array to the controller and energy source. Further, all the coils 1508 of the array 1500 may form a closed circuit by directing current from the array to the single energy or battery source via the one output terminal 1524.


Preferably, positioned between each coil piece 1504 or coil 1508 is a material that may act as a cushion, barrier, or padding 1518 that functions to both prevent the coil pieces from 1504 shifting and to gently position the array 1500 against the user's skin. Additionally, or alternatively, area 1518 may include an adhesive to attach, secure, or otherwise fixedly position the array 1500 against the user's skin. Additionally, or alternatively, area 1518 may include an attachment mechanism, such as Velcro or snaps, to attach area 1518, and therefore array 1500, to another substrate or material to form a piece of clothing, as further discussed below.


It should be appreciated that the directionality of the current of each coil may be modified to achieve a desired magnetic flux level by properly routing its input lead or output lead to the input or output side of the array 1500. Referring to FIG. 16, in this array 1600, the top coils 1632 and the bottom coils 1636 have counterclockwise currents. The directionality of the current of a coil may be modified by changing which lead, extending from that coil, is routed to the input terminal and is routed to the output terminal. For example, if lead A is directed to the input terminal and lead B is directed to the output terminal, the current directionality of the corresponding coil may be clockwise. That current directionality may be switched to become counterclockwise by routing lead A to the output terminal and lead B to the input terminal


It should further be appreciated that the form factor and range of coil sizes and relative separation between coil pieces are important to achieving two core objectives. First, the coil footprint should not be too large, and the coil separation should not be too small, otherwise the array will not be flexible enough to conform to uneven or non-planar portions of a user's body. Second, the coil footprint should not be too small, and the coil separation should not be too large, otherwise the array will not generate a sufficiently large magnetic flux for therapeutic purposes. Hence, the dimensions and distances disclosed herein have a distinct utility and are not merely aesthetic in nature.


Stimulation Protocols


The controller is configured to generate an electrical current, and selectively transmit the electrical current to all of the plurality of planar microcoils, or a subset of the plurality of planar microcoils, in order to generate pulsed electromagnetic fields in accordance with one or more of FIGS. 10A to 10G. The electrical current may be a sinusoidal curve 1000a defined by a first period, a sinusoidal curve 1000b defined by a second period, or a sinusoidal curve 1000c defined by a third period where each of the three periods are of different lengths. The electrical current may also be a sinusoidal curve 1000d having a varying amplitude. In other embodiments, the electrical current pulse may be a trapezoidal 1000e, a spike 1000f, or square shaped 1000g. Referring to FIG. 10G, in one embodiment, the stimulation pulse, or shape of the electrical current pulse, may comprise a series of pulse trains 1000g, each defined by a set of ramping square pulses, 1005g, 1015g, 1020g. In particular, within a stimulation session, each pulse train 1000g may be initiated at a frequency in a range from 5 Hz to 200 Hz, preferably in a range of 8 to 30 Hz. Each pulse train 1000g comprises at least 1 square pulse, typically having an amplitude of between 20 and 100 mA. More preferably, each pulse train 1000g comprises a series of ramping square pulses, 1005g, 1015g, 1020g, that increase in amplitude from a first pulse in a range of 20 to 50 mA, to a second pulse in a range of 40 to 70 mA, to a third pulse in a range of 60 to 100 mA. It should be appreciated that other ramping configurations could be implemented, including a down ramping pulse that, in the course of the pulse train, decreases in amplitude.


A stimulation session may go from 1 minute to 24 hours. As described above, within a given stimulations session, you may have a series of pulse bursts. A pulse burst may have one or more pulses. Each pulse in the pulse burst may have the same or different pulse shapes, as shown in FIGS. 10A-10F. Each pulse in the pulse burst may have the same or different amplitude. In one preferred stimulation, there are multiple pulses in a pulse burst where the amplitude of each pulse burst ramps from low to high or ramps from high to low. Each pulse amplitude causes a generation of a field in the range of 1 to 10000 microTesla, preferably 3 to 500 microTesla, preferably 10 to 200 microTesla. The frequency of the pulse burst is in a range of 1 to 500 Hz, preferably 5 to 30 Hz, and more preferably 6 to 15 Hz. Amperage is dependent on the selected planar microcoil design but is in a range of 1 mAmp to 5 Amp. In embodiments, the pulse bursts may have characteristics as described with reference to Table 2 below:









TABLE 2





Pulse Burst Characteristics



















Amplitude of
1 mAmp to 1 Amp
1 mAmp to 1 Amp
1 mAmp to 1 Amp
1 mAmp to 1 Amp


electrical signal
(preferably 0.1,
(preferably 0.1,
(preferably 0.1,
(preferably 0.1,


generated by the
0.2, 0.4 0.5,
0.2, 0.4 0.5,
0.2, 0.4 0.5,
0.2, 0.4 0.5,


controller
0.55 Amps)
0.55 Amps)
0.55 Amps)
0.55 Amps)


Frequency of
1 Hz to 500 Hz
1 Hz to 500 Hz
1 Hz to 500 Hz
1 Hz to 500 Hz


electrical pulse
(preferably 5 to
(preferably 5 to
(preferably 5 to
(preferably 5 to


bursts (each burst
30 Hz, more
30 Hz, more
30 Hz, more
30 Hz, more


contains one or
preferably 5 to
preferably 5 to
preferably 5 to
preferably 5 to


more pulses)
15 Hz)
15 Hz)
15 Hz)
15 Hz)


Number of pulses
1 to 20
1 to 20
1 to 20
1 to 20


in each burst


Ramping
No ramping (all
No ramping (all
No ramping (all
No ramping (all



pulses are equal
pulses are equal
pulses are equal
pulses are equal



in amplitude),
in amplitude),
in amplitude),
in amplitude),



ramping up (first
ramping up (first
ramping up (first
ramping up (first



pulse is less than
pulse is less than
pulse is less than
pulse is less than



the last pulse in
the last pulse in
the last pulse in
the last pulse in



the burst),
the burst),
the burst),
the burst),



ramping down
ramping down
ramping down
ramping down



(first pulse is
(first pulse is
(first pulse is
(first pulse is



more than the last
more than the last
more than the last
more than the last



pulse in the burst)
pulse in the burst)
pulse in the burst)
pulse in the burst)


Shape of each
Square,
Square,
Square,
Square,


pulse in the pulse
Trapezoidal,
Trapezoidal,
Trapezoidal,
Trapezoidal,


burst
Sinusoidal
Sinusoidal
Sinusoidal
Sinusoidal


Generated EMF
1 microTesla to
1 microTesla to
1 microTesla to
1 microTesla to


field over the
10 milliTesla
10 milliTesla
10 milliTesla
10 milliTesla


surface area of the


coil and extending


outward from the


surface of the coil


in a range of 0 mm


to 20 mm










Controller Software


In one embodiment, the treatment systems disclosed herein, including the coils, coil arrays, and controller circuit configured to generate and deliver electrical current to the coils and coil arrays, are controlled by a software application configured to be installed and execute on a separate computing device, such as a mobile phone, laptop, or external controller, that is in wired or wireless communication with the controller circuit.


In one embodiment, the software application, or controller application, is configured to identify a type of coil system being used by a patient. Operationally, the controller application may be installed on a mobile phone and be configured to use a camera functionality of the mobile phone to capture a bar code, QR code, or other identification or be configured to generate a graphical user interface to receive an alphanumeric identifier of the coil system. Based on the data provided, the controller application may 1) validate the coil system as being a legitimate, authorized, or otherwise acceptable coil system, 2) determine what type of coil system is being used and whether that coil system is specific to a particular anatomical region, e.g. a coil system specific to a neck region, torso region, back region, leg region, foot region, arm region, head region, or other anatomical region, and 3) based upon that determination, generate graphical user interfaces that display anatomical regions specific to the coil system being used, e.g. if the coil system is specific to a neck region the generated graphical user interfaces visually display a neck, if the coil system is specific to a torso region the generated graphical user interfaces visually display a torso, if the coil system is specific to a back region the generated graphical user interfaces visually display a back region, if the coil system is specific to a leg region the generated graphical user interfaces visually display a leg region, if the coil system is specific to a foot region the generated graphical user interfaces visually display one or more feet, if the coil system is specific to an arm region the generated graphical user interfaces visually display one or more arms, and if the coil system is specific to a head region the generated graphical user interfaces (GUIs) visually display a head region.


In one embodiment, the generated GUIs are configured to receive an input from a patient as to a locus or loci of pain relative to the displayed anatomical region. For example, upon displaying the anatomical region in a GUI, a patient may paint, using a stylet or finger pressed upon a display, an area of the anatomical region that may be in pain. One or more GUIs may then be presented to prompt from a patient, and receive from the patient, an indication of the level of the pain via, for example, a visual analog scale where a user may indicate using numbers or icons a degree of the pain.


Based upon the highlighted anatomical region and the level of pain, the controller software determines 1) a desired level of magnetic flux to be delivered, 2) a corresponding set of coils to be energized in what order and at what frequency, and 3) a level of current to be delivered to each coil or coil array to generate the desired level of magnetic flux in the right location and at the right frequency. In particular, different locus or loci of pain may require an increased or decreased intensity or frequency of magnetic flux to be delivered at nerves located upstream or downstream from the locus or loci of pain. The controller software therefore comprises programmatic instructions, and supporting data, that correlates anatomical locations of pain with nerve areas that are co-located with the locus or loci of pain, upstream from the locus or loci of pain and/or downstream from the locus or loci of pain. In one embodiment, the controller software becomes aware of the location of specific coils or coil arrays based on at least one of 1) a preset relationship of the coils/coil arrays that is stored and known to the controller software based on identifying the type of coil system or 2) input by a user that indicates to the controller software where each of the coils are being positioned on a patient—such an indication being provided through a GUI that presents possible anatomical locations either through text or graphically.


In one embodiment, the software application, or controller application, is configured to generate instructions that, when communicated to and executed by the controller circuit, causes the controller circuit to generate electrical current and deliver that electrical current to different coils and/or coil arrays based on the desired frequency, intensity level, order, and location, as described above. For example, if a patient is suffering from acute pain on top of his or her right foot, the controller software may determine that coil arrays positioned on top of his or her right foot need to generate a magnetic flux in a range of 100 microTesla at a frequency of 10 Hz while coils positioned in the sole of the footwear, proximate the bottom of the patient's foot, need only be activated to generate a magnetic flux in a range of 20 microTesla at a frequency of 30 Hz.


In another embodiment, the controller circuit may be configured to electrically connect with a coil array or coils and upon making such a connection, to detect and store an identifier of the coil array or coil. The controller circuit preferably stores each of the identifiers and communicates it to the controller software upon connecting. These identifiers may be further used to identify the validity and/or type of coils or coil arrays being used.


To determine desired dosing levels, in another embodiment, the controller software may include a set of programmatic instructions for dose training. In one embodiment, the controller software operates in a training mode in which 1) a user is prompted to provide real-time feedback on pain levels using a visual analog scale, 2) the controller software modulates, over predefined periods of time, the frequency of pulse signals, the amount of current (and therefore magnetic flux intensity level) and/or the shape of the pulse signals in various combinations over the predefined period of time, and 3) as the parameters change, the user is prompted to input feedback on pain levels through the visual analog scale. For example, once a user identifies a locus of loci of pain, it initiates a cycling process starting with a set of frequency and modulating the current level and therefore the magnetic flux level up and down, prompting the user for feedback on pain levels during the cycling process. The controller software may then change frequency settings and repeat the up and down modulation of current level and magnetic flux level, again concurrently prompting the user for feedback on pain levels during the cycling process. Once the cycling processes are completed, the controller software analyzes the user's feedback to determine an optimal combination of frequency and current level for a given locus or loci of pain.


Integration of Planar Microcoils with Clothing


To improve patient compliance and provide for ease of use, the patches comprising planar microcoil arrays are integrated into clothing. Referring to FIGS. 11A to 11E and 12A to 12E, the patches 1105, 1205 are sandwiched between a first outer layer and a second inner layer (closer to body) where the second layer is the same material as the first layer but thinner or is of a different material and thicker or thinner than the first layer. The patches are connected to a controller strip 1115, 1215 positioned at the base of the shirt (11A, 12A), top of the socks (11B, 12B), the base of a mask or neck covering (11C, 12C), top of pants (11D, 12D), or base of a glove (11E, 12E). Preferably, the controller comprises a rechargeable battery. Alternatively, the patches may be connected to a docking station to which a controller may be removably attached, as described above.


It should be appreciated that the array sizes may be variable. For example, as shown in each of the FIGS. 12A to 12E, one may have a plurality of planar microcoils integrated onto a small substrate surface area 1207, i.e. in a range of 0.5 in2 to 2 in2, or onto a larger substrate surface area 1209, i.e. in a range of 2.01 in2 to 120 in2. The smaller substrate surface areas 1207 are designed to be positioned near crevices, curves, or other non-planar anatomical areas of the patient, such as the areas in or around the toes. The larger substrate surface areas 1209 are designed to be positioned on substantially planar surface areas, such as portions of the arms, legs, and back.


It should further be appreciated that the planar microcoil arrays are preferably integrated into a layer of the clothing and are not directly exposed to the user's skin or to the outside environment. Referring to the shirt, head covering, foot covering, and hand coverings shown in FIGS. 12A-12E and further including elbow, knee, leg, ankle, shoulder, or neck braces made from materials ranging from polyester to lycra or spandex, the planar microcoil arrays and associated traces may be incorporated into a layer positioned between an innermost layer of clothing, which touches the user's skin, and an outermost layer of clothing, which is exposed to the outside environment.


Footwear


In one embodiment, the present invention is directed toward the integration of coils and/or coil arrays into footwear, such as a shoe, boot, sock, or other foot covering. The sole or base of the footwear 1401 comprises a plurality of individual coils, such as Coil S1, Coil S2, and Coil S3, and/or coil arrays, such as Array S1 that are distributed on a surface of the sole or base. The individual coils, such as Coil S1, Coil S2, and Coil S3, and/or coil arrays, such as Array S1 may be of the type described herein or

    • 1. Coil S1: 6 by 5 cm, inner air core: 0.2 by 1.2 cm, 800 to 1,500 turns (preferably 1200-1300 turns), 0.04 mm wire thickness or larger.
    • 2. Coil S2: 7 by 5.1 cm, inner air core: 0.2 by 2.3 cm, 800 to 1500 turns (preferably 1200-1300 turns), 0.04 mm wire thickness or larger.
    • 3. Coil S3: 3 by 4.5 cm, inner air core: 0.2 by 1.7 cm, 700 turns, 0.04 mm wire thickness


Preferably, the individual coils, such as Coil S1, Coil S2, and Coil S3, and/or coil arrays, such as Array S1 are configured to be of different sizes with Coil S1 being larger or having more windings than Coil S2 or Coil S3 and where a distance between the Coil S1, Coil S2, and Coil S3 is between 1 cm and 3 cm, preferably around 2 cm. Each of the Coil S1, Coil S2, and Coil S3 are in electrical communication with the controller 1403. The controller 1403 is also in electrical communication with a plurality of coil arrays U1, U2, U3, U4, U5, and/or U6 1402 that are integrated into the upper of the footwear and configured to cover the entirety of the user's foot. As discussed above, each of the coil arrays may be energized and/or controller as described above to address a user's foot pain.


Optionally, the ankle region of the footwear device may comprise two large coils which are positioned on opposing sides of the ankle region and are spaced and sized to function as Helmholtz coils.


Referring to FIG. 18, a PEMF device 1800 configured to comfortably conform to a patient's head is shown. A flexible material 1880 configured as a headband and made out of cotton, terry cloth, polyester, or other materials. Integrated into a layer of the headband 1880 are a plurality of planar microcoil arrays 1805 which are in electrical communication with a docking station and controller 1870, as described above. The headband may be adjustable by having an attachment mechanism 1890 which permits for the relative circumferential extent of the headband to be adjusted. The attachment mechanism 1890 can use, for example, a Velcro connection which can thereby adjust to the size of the user's head. Preferably there are enough planar microcoil arrays to extend along the template region of the user's head. More preferably there are enough planar microcoil arrays to extend along the entire circumferential extent of the headband.


Referring to FIG. 19, an article of clothing with a set of planar microcoils integrated therein 1900. A layer of clothing 1910b, which faces the outside environment, has, positioned on top of it, and opposing the outside layer, a set of planar microcoil arrays 1920 that are connected by traces. A layer of clothing 1910a, configured to face the skin of a user, is positioned on top of the set of planar microcoil arrays 1920. In one embodiment, the layer of clothing 1910a is contiguous and uniform. In another embodiment, the layer of clothing 1910a has a window that exposes the coils of the arrays, and therefore the generated magnetic fields, to the skin of the user. The window may be just a space or made of a different material, such as a clear plastic or a thinner material than the rest of layer 1910a. A buffer material 1930 may be positioned between the arrays to keep the arrays 1920 in position and physically separated from each other. The buffer material may be any non-conductive material, including cotton, polyester, or wool.


It should be appreciated that, upon activation, magnetic fields are generated in accordance with the stimulation protocols described above. Conventionally, it is believed that very large magnetic fields have to be directed into the brain to have any tangible therapeutic effects on certain conditions, such as depression. However, it is believed that, by modulating a position, configuration, orientation, or movement, of magnetite chains in one or more brain cells or neurons, which may be effectuated by magnetic fields less than 100 microTesla or by applying a sufficient magnetic field gradient, which is determined by the frequency and shape of pulse, one can cause a normalization of magnetite functionality, at least during the application of the magnetic fields. Normalization of magnetite functionality may thereby enable at least a partial alleviation of symptoms associated with anxiety disorders, obsessive compulsive disorder, post-traumatic stress disorder, memory degeneration, schizophrenia, Parkinson's disease, stroke rehabilitation, drug addiction, including addiction to, or cravings for, nicotine, cocaine, alcohol, heroine, methamphetamines, stimulants, and/or sedatives, depression and depression-related conditions, such as post-partum depression or bipolar depression, auditory hallucinations, multiple sclerosis, fibromyalgia, Alzheimer's disease, spinocerebellar degeneration, epilepsy, urinary incontinence, movement disorders, chronic tinnitus, or sleep apnea while the magnetic fields are being applied to the brain. Accordingly, it is within the scope of this invention to treat symptoms related to disorders having a loci of dysfunction in the brain by normalizing at least one of a position, configuration, orientation, or movement of magnetite chains in one or more brain cells or neurons by applying magnetic fields less than 100 microTesla or by applying a sufficient magnetic field gradient.


It should further be appreciated that other embodiments may be specifically designed to be directed toward 1) treating osteoporosis by, for example, positioning a plurality of arrays along a length of substrate configured to extend over an entire length of a user's spine, each of said arrays being in electrical communication with a controller, 2) effectuating an activation of acupoints that may be distributed over various areas of the user's body, where at each acupoint an array is positioned and where all of the arrays are in electrical communication with a controller; optionally, a coil that aligns with an acupoint may be configured to receive a higher level of current and generate a higher magnetic flux than the rest of the coils which are not aligned with an acupoint, 3) treating a neck region to reduce increase and increase a collagen framework, where a plurality of arrays are configured to extend around a neck region of the user, each of the arrays being in electrical communication with a controller, and 4) treating one or more broken bones by providing a plurality of arrays configured to be positioned on a user's skin and between a cast and the user's skin, each of the arrays being electrical communication with a controller.


Referring to FIG. 20, in one embodiment, a method 2000 of treating a condition is provided. An article of clothing is attached 2005 to a portion of a patient's body. The article of clothing comprises a plurality of planar microcoil arrays, wherein each of the plurality of planar microcoil arrays comprises two or more planar microcoils positioned on a flexible substrate, wherein each of the plurality of planar microcoil arrays is integrated into the article of clothing; and wherein each of the plurality of planar microcoil arrays is in electrical communication with a docking station integrated into the article of clothing. A controller is attached 2010 to the docking station, wherein the controller comprises a circuit and a power source. Preferably, upon attaching the controller to the docking station, the circuit automatically electrically interfaces with at least one of the plurality of planar microcoil arrays. The docking station is optional. The controller may be directly integrated into the article of clothing. The controller is activated 2015 to cause a time varying current to be transmitted to each of the plurality of planar microcoil arrays.


The condition is at least one of an anxiety disorder, an obsessive compulsive disorder, a post-traumatic stress disorder, memory degeneration, schizophrenia, Parkinson's disease, stroke rehabilitation, drug addiction, drug cravings, depression, depression-related conditions, post-partum depression, bipolar depression, auditory hallucinations, multiple sclerosis, fibromyalgia, Alzheimer's disease, spinocerebellar degeneration, epilepsy, urinary incontinence, movement disorders, chronic tinnitus, or sleep apnea.


The article of clothing may be attached such that at least one of the two or more planar microcoils in at least one of the plurality of planar microcoil arrays is positioned over an acupoint of the patient's body. Additionally, prior to attaching the article of clothing, a skin impedance measurement may be made and, based on the level of impedance, the article of clothing may be attached such that at least one of the two or more planar microcoils in at least one of the plurality of planar microcoil arrays is positioned over an area of impedance that exceeds a predefined threshold value. Accordingly, an impedance measurement sensor and circuit may also be integrated into the article of clothing.


While the exemplary embodiments of the present invention are described and illustrated herein, it will be appreciated that they are merely illustrative. It will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from or offending the spirit and scope of the invention.

Claims
  • 1. A pulsed electromagnetic field device comprising: an article of clothing;a controller; anda plurality of planar microcoil arrays, wherein each of the plurality of planar microcoil arrays comprises a flexible substrate and two or more planar microcoils embedded in the flexible substrate, wherein each of the two or more planar microcoils is defined by a conductive pathway embedded within the flexible substrate, wherein a first of the plurality of planar microcoil arrays is physically spaced apart from, and non-contiguous with, a a second of the plurality of planar microcoil arrays, wherein each of the plurality of planar microcoil arrays is integrated into the article of clothing; and wherein each of the plurality of planar microcoil arrays is in electrical communication with the controller such that the first of the plurality of planar microcoil arrays and the second of the plurality of planar microcoil arrays are electrically coupled to the controller in parallel.
  • 2. The pulsed electromagnetic field device of claim 1, further comprising a docking station, wherein the docking station is configured to releasably receive the controller.
  • 3. The pulsed electromagnetic field device of claim 2, wherein the docking station comprises a first mechanical connector and a first electrical interface, wherein the controller comprises a second mechanical connector and a second electrical interface, and wherein, upon the first mechanical connector and the second mechanical connector latching, the first electrical interface is automatically placed in electrical communication with the second electrical interface.
  • 4. The pulsed electromagnetic field device of claim 1, wherein the article of clothing comprises two or more layers of material and wherein the plurality of planar microcoil arrays is positioned between the two or more layers of material.
  • 5. The pulsed electromagnetic field device of claim 1, wherein the article of clothing is a sock, a shoe, a shirt, a pant, a glove, a mask, a neck covering, a head covering, a headband, a sleeve, or a brace configured to fit over an elbow, an ankle, or a knee.
  • 6. The pulsed electromagnetic field device of claim 1, wherein the controller is configured to generate a pulse train, wherein each pulse train comprises a plurality of pulses having an amplitude in a range of 1 mA to 200 mA.
  • 7. The pulsed electromagnetic field device of claim 6, wherein the pulse train comprises a first pulse having a first amplitude, a second pulse having a second amplitude, and a third pulse having a third amplitude, wherein the first amplitude is less than the second amplitude and the second amplitude is less than the third amplitude.
  • 8. The pulsed electromagnetic field device of claim 7, wherein each of the first pulse, second pulse, and third pulse has a square shape.
  • 9. The pulsed electromagnetic field device of claim 6, wherein each of the two or more planar microcoils is configured to generate a magnetic field in a range of 3 microTesla to 500 microTesla upon receiving the pulse train.
  • 10. The pulsed electromagnetic field device of claim 1, wherein each of the plurality of planar microcoil arrays comprises at least six planar microcoils.
  • 11. The pulsed electromagnetic field device of claim 10, wherein each of the plurality of planar microcoil arrays comprises an input terminal configured to receive current from the controller, an output terminal, and at least two traces to electrically connect each of the at least six planar microcoils to the input terminal and the output terminal.
  • 12. The pulsed electromagnetic field device of claim 11, wherein a first set of the at least six planar microcoils is configured to direct current clockwise and wherein a second set of the at least six planar microcoils is configured to direct current counterclockwise.
  • 13. The pulsed electromagnetic field device of claim 11, wherein the input terminal, output terminal, and at least two traces are each embedded into the flexible substrate.
  • 14. The pulsed electromagnetic field device of claim 12, wherein a number of coils in the first set of the at least six planar microcoils is equal to a number of coils in the second set of the at least six planar microcoils.
  • 15. The pulsed electromagnetic field device of claim 11, wherein all of the at least six planar microcoils are configured to direct current in a same direction.
  • 16. The pulsed electromagnetic field device of claim 1, wherein each of the two or more planar microcoils is at least one of a spiral circular planar microcoil, a rectangular circular planar microcoil, a non-spiral circular planar microcoil, or a non-spiral rectangular planar microcoil.
  • 17. The pulsed electromagnetic field device of claim 1, wherein a first subset of the plurality of planar microcoil arrays has a different surface area than a second subset of the plurality of planar microcoil arrays.
  • 18. The pulsed electromagnetic field device of claim 1, wherein each of the plurality of planar microcoil arrays has a same surface area.
  • 19. The pulsed electromagnetic field device of claim 1, wherein the controller is configured to generate a time varying current in order to create a time varying magnetic field at each of the plurality of planar microcoil arrays.
  • 20. The pulsed electromagnetic field device of claim 19, wherein the time varying current is defined by square waves having substantially equal peak amplitude values.
  • 21. The pulsed electromagnetic field device of claim 19, wherein the time varying current is defined by sinusoidal waves having substantially equal peak amplitude values.
  • 22. The pulsed electromagnetic field device of claim 19, wherein the time varying current is defined by square waves having substantially different peak amplitude values.
  • 23. The pulsed electromagnetic field device of claim 19, wherein the time varying current is defined by a train of square waves and wherein, in each train, the square waves have peak values that ramp from a low peak amplitude value to a higher peak amplitude value.
  • 24. The pulsed electromagnetic field device of claim 1, wherein the controller is configured to cause an electrical current to be concurrently transmitted to all of the plurality of planar microcoil arrays.
  • 25. The pulsed electromagnetic field device of claim 1, wherein the controller is configured to cause an electrical current to be transmitted to all of the plurality of planar microcoil arrays at different times.
  • 26. The pulsed electromagnetic field device of claim 1, further comprising a set of programmatic instructions stored on a separate computing device, wherein, when executed by the separate computing device, the programmatic instructions generate a display for prompting a user to input a pain level and a locus of pain.
  • 27. The pulsed electromagnetic field device of claim 26, wherein, when executed by the separate computing device, the programmatic instructions determine which of the plurality of planar microcoil arrays should receive an electrical current based on at least one of the pain level or the locus of pain.
  • 28. The pulsed electromagnetic field device of claim 26, wherein, when executed by the separate computing device, the programmatic instructions generate data indicative of which of the plurality of planar microcoil arrays should receive an electrical current based on at least one of the pain level or the locus of pain and transmit the data to the controller.
  • 29. The pulsed electromagnetic field device of claim 28, wherein the controller generates an electrical current based on the data and in a predefined pattern based on at least one of the pain level or the locus of pain.
  • 30. The pulsed electromagnetic field device of claim 1, further comprising a plurality of traces integrated into the article of clothing and extending from each of the plurality of planar microcoil arrays to the controller.
  • 31. A method of treating a condition, comprising: forming an article of clothing adapted to be attached to a portion of a patient's body, wherein the article of clothing comprises a plurality of planar microcoil arrays, wherein each of the plurality of planar microcoil arrays comprises a flexible substrate and two or more planar microcoils embedded in the flexible substrate, wherein each of the two or more planar microcoils is defined by a conductive pathway embedded within the flexible substrate, wherein a first of the plurality of planar microcoil arrays is physically spaced apart from and non-contiguous with a second of the plurality of planar microcoil arrays, wherein each of the plurality of planar microcoil arrays is integrated into the article of clothing; and wherein each of the plurality of planar microcoil arrays is in electrical communication with a connector integrated into the article of clothing;attaching a controller to the connector, wherein the controller comprises a circuit and a power source; andactivating the controller to cause a time varying current to be transmitted to each of the plurality of planar microcoil arrays such that the first of the plurality of planar microcoil arrays and the second of the plurality of planar microcoil arrays are electrically coupled to the controller in parallel.
  • 32. The method of claim 31, wherein the condition is at least one of an anxiety disorder, an obsessive compulsive disorder, pain, a post-traumatic stress disorder, memory degeneration, schizophrenia, Parkinson's disease, stroke rehabilitation, drug addiction, drug cravings, depression, depression-related conditions, post-partum depression, bipolar depression, auditory hallucinations, multiple sclerosis, fibromyalgia, Alzheimer's disease, spinocerebellar degeneration, epilepsy, urinary incontinence, movement disorders, chronic tinnitus, or sleep apnea.
  • 33. The method of claim 31, further comprising attaching the article of clothing such that at least one of the two or more planar microcoils in at least one of the plurality of planar microcoil arrays is positioned over an acupoint of the patient's body.
  • 34. The method of claim 31, wherein, upon attaching the controller to the connector, the circuit automatically electrically interfaces with at least one of the plurality of planar microcoil arrays.
CROSS-REFERENCE

The present application relies on U.S. Patent Provisional No. 62/892,751, entitled “Systems and Methods of Treating Medical Conditions Using Arrays of Planar Coils Configured to Generate Pulsed Electromagnetic Fields” and filed on Aug. 28, 2019, for priority. The present application also relies on U.S. Patent Provisional No. 62/843,727, entitled “Systems and Methods of Treating Medical Conditions Using Arrays of Planar Coils Configured to Generate Pulsed Electromagnetic Fields” and filed on May 6, 2019, for priority. Both applications are incorporated herein by reference.

US Referenced Citations (297)
Number Name Date Kind
5368544 Tran Nov 1994 A
5470846 Sandyk Nov 1995 A
5691324 Sandyk Nov 1997 A
5691325 Sandyk Nov 1997 A
5885976 Sandyk Mar 1999 A
6267720 Knox Jul 2001 B1
6561968 Dissing May 2003 B1
7740574 Pilla Jun 2010 B2
7744524 Pilla Jun 2010 B2
7758490 Pilla Jul 2010 B2
7896797 Pilla Mar 2011 B2
8039031 Baianu Oct 2011 B2
8262556 Fischell Sep 2012 B2
8343027 Dimino Jan 2013 B1
8415123 Pilla Apr 2013 B2
8460167 Chornenky Jun 2013 B2
8827886 Chornenky Sep 2014 B2
8932196 Chornenky Jan 2015 B2
8944985 Bonmassar Feb 2015 B2
8961385 Pilla Feb 2015 B2
9320913 Dimino Apr 2016 B2
9403028 Greff Aug 2016 B2
9410143 Rudd Aug 2016 B1
9415233 Pilla Aug 2016 B2
9427598 Pilla Aug 2016 B2
9433797 Pilla Sep 2016 B2
9440089 Pilla Sep 2016 B2
9486638 Chornenky Nov 2016 B2
9550067 Fischell Jan 2017 B1
9656096 Pilla May 2017 B2
9873000 Moss Jan 2018 B2
9968797 Sham May 2018 B2
10207122 Pilla Feb 2019 B2
10226640 Pilla Mar 2019 B2
10238867 Ryaby Mar 2019 B2
10350428 Pilla Jul 2019 B2
10398906 Jin Sep 2019 B2
10413816 Moir Sep 2019 B2
10426967 Pilla Oct 2019 B2
10441807 Moffett Oct 2019 B2
10471272 Goetz Nov 2019 B2
10556121 Gurfein Feb 2020 B2
10806942 Hochstenbach Oct 2020 B2
20010047301 Walker Nov 2001 A1
20020032667 Walker Mar 2002 A1
20020035358 Wang Mar 2002 A1
20020036367 Walmer Mar 2002 A1
20020043301 Walmer Apr 2002 A1
20020052634 March May 2002 A1
20020066702 Liu Jun 2002 A1
20020165583 Tepper Nov 2002 A1
20020165771 Walker Nov 2002 A1
20020188164 Loos Dec 2002 A1
20030054888 Walker Mar 2003 A1
20030094911 Chukanov May 2003 A1
20030153965 Supronowicz Aug 2003 A1
20030158583 Burnett Aug 2003 A1
20030158585 Burnett Aug 2003 A1
20030233122 Azure Dec 2003 A1
20040034388 Azure Feb 2004 A1
20040039639 Walker Feb 2004 A1
20040116176 Tulley Jun 2004 A1
20040140352 Walker Jul 2004 A1
20040176803 Whelan Sep 2004 A1
20040176805 Whelan Sep 2004 A1
20040181115 Sandyk Sep 2004 A1
20040210254 Burnett Oct 2004 A1
20040241311 Baianu Dec 2004 A1
20050024260 Johnston Feb 2005 A1
20050043994 Walker Feb 2005 A1
20050049640 Gurtner Mar 2005 A1
20050084962 Simon Apr 2005 A1
20050104768 Johnston May 2005 A1
20050110837 Silverbrook May 2005 A1
20050187012 Walker Aug 2005 A1
20050220674 Shafirstein Oct 2005 A1
20050271738 Simon Dec 2005 A1
20060030896 Simon Feb 2006 A1
20060052658 Ozpapu Mar 2006 A1
20060057693 Simon Mar 2006 A1
20060063963 Brunelle Mar 2006 A1
20060129456 Walker Jun 2006 A1
20060223616 Tulley Oct 2006 A1
20060223617 Tulley Oct 2006 A1
20060224456 Walker Oct 2006 A1
20060229944 Walker Oct 2006 A1
20060229945 Walker Oct 2006 A1
20060241333 Hunter Oct 2006 A1
20060241965 Walker Oct 2006 A1
20060241966 Walker Oct 2006 A1
20060246991 Tulley Nov 2006 A1
20070010314 Tulley Jan 2007 A1
20070026929 Tulley Feb 2007 A1
20070050711 Walker Mar 2007 A1
20070060477 Pedersen Mar 2007 A1
20070066995 Strother Mar 2007 A1
20070067004 Boveja Mar 2007 A1
20070073773 Walker Mar 2007 A1
20070073774 Walker Mar 2007 A1
20070073775 Walker Mar 2007 A1
20070104694 Quijano May 2007 A1
20070105769 Simon May 2007 A1
20070125851 Walker Jun 2007 A1
20070167213 Tulley Jul 2007 A1
20070167214 Tulley Jul 2007 A1
20070167990 Mangrum Jul 2007 A1
20070187539 Hoppe Aug 2007 A1
20070282388 Sandyk Dec 2007 A1
20080059318 Packes, Jr. Mar 2008 A1
20080103558 Wenzel May 2008 A1
20080125617 Puchek May 2008 A1
20080201232 Walker Aug 2008 A1
20080204021 Leussler Aug 2008 A1
20080208663 Walker Aug 2008 A1
20080217263 Higgins Sep 2008 A1
20080229795 Toeniskoetter Sep 2008 A1
20080249879 Walker Oct 2008 A1
20080280826 O'Connor Nov 2008 A1
20080288035 Gill Nov 2008 A1
20080300912 Packes, Jr. Dec 2008 A1
20090013583 Leung Jan 2009 A1
20090163762 Setti Jun 2009 A1
20090171417 Philipson Jul 2009 A1
20090208598 Novitsky Aug 2009 A1
20090224037 Walker Sep 2009 A1
20090227831 Burnett Sep 2009 A1
20090254531 Walker Oct 2009 A1
20090299128 Setti Dec 2009 A1
20090304542 Sterling Dec 2009 A1
20090310331 Leung Dec 2009 A1
20100049262 Puchek Feb 2010 A1
20100057146 Gleim Mar 2010 A1
20100121131 Mathes May 2010 A1
20100160712 Burnett Jun 2010 A1
20100185523 Tulley Jul 2010 A1
20100210893 Pilla Aug 2010 A1
20100211174 Scarborough Aug 2010 A1
20100222630 Mangrum Sep 2010 A1
20100233305 Farzamfar Sep 2010 A1
20100239544 Simon Sep 2010 A1
20100274177 Rybski Oct 2010 A1
20110004261 Sham Jan 2011 A1
20110065976 Chornenky Mar 2011 A1
20110105959 O'Connor May 2011 A1
20110112352 Pilla May 2011 A1
20110124717 O'Connor May 2011 A1
20110125287 Hotter May 2011 A1
20110130618 Ron Edoute Jun 2011 A1
20110152667 Doerr Jun 2011 A1
20110152672 Doerr Jun 2011 A1
20110152674 Doerr Jun 2011 A1
20110152972 Doerr Jun 2011 A1
20110207989 Pilla Aug 2011 A1
20110248019 Chew Oct 2011 A1
20110283607 Gleim Nov 2011 A1
20110302161 Walker Dec 2011 A1
20110313235 Gleim Dec 2011 A1
20120010559 Higgins Jan 2012 A1
20120064594 Van Bree Mar 2012 A1
20120071235 Walker Mar 2012 A1
20120101327 Dissing Apr 2012 A1
20120116149 Pilla May 2012 A1
20120143285 Wang Jun 2012 A1
20120157747 Rybski Jun 2012 A1
20120172653 Chornenky Jul 2012 A1
20120184802 Gleim Jul 2012 A1
20120191159 Willeford Jul 2012 A1
20120205558 Jindal Aug 2012 A1
20120209055 Gleim Aug 2012 A1
20120330090 Sham Dec 2012 A1
20120330771 Walker Dec 2012 A1
20130035538 Maestu Unturbe Feb 2013 A1
20130035539 Kornstein Feb 2013 A1
20130062193 Proudkii Mar 2013 A1
20130085317 Feinstein Apr 2013 A1
20130158634 Ron Edoute Jun 2013 A1
20130164736 Bernardi Jun 2013 A1
20130178425 Higgins Jul 2013 A1
20130211896 Walker Aug 2013 A1
20130218700 Walker Aug 2013 A1
20130238062 Ron Edoute Sep 2013 A1
20130289433 Jin Oct 2013 A1
20130317282 Ron Edoute Nov 2013 A1
20130328552 Chen Dec 2013 A1
20130334857 Wolsiefer Dec 2013 A1
20140024882 Chornenky Jan 2014 A1
20140046116 Gleim Feb 2014 A1
20140072926 Valoir Mar 2014 A1
20140081070 Paukshto Mar 2014 A1
20140102947 Baym Apr 2014 A1
20140152227 Tuval Jun 2014 A1
20140155680 Higgins Jun 2014 A1
20140171789 Barth Jun 2014 A1
20140175330 Black Jun 2014 A1
20140213843 Pilla Jul 2014 A1
20140213844 Pilla Jul 2014 A1
20140221726 Pilla Aug 2014 A1
20140249354 Anderson Sep 2014 A1
20140249355 Martinez Sep 2014 A1
20140274893 Woodell-May Sep 2014 A1
20140274894 Leach Sep 2014 A1
20140274895 Binder Sep 2014 A1
20140330067 Jordan Nov 2014 A1
20140378812 Saroka Dec 2014 A1
20150025299 Ron Edoute Jan 2015 A1
20150141737 Willeford May 2015 A1
20150151136 Ruetenik Jun 2015 A1
20150198381 Kuehl Jul 2015 A1
20150217125 Chornenky Aug 2015 A1
20150297910 Dimino Oct 2015 A1
20150300299 Licitar Oct 2015 A1
20150306412 Durschmidt Oct 2015 A1
20150315539 Villanueva Nov 2015 A1
20150320697 O'Connor Nov 2015 A1
20150328476 Anderson Nov 2015 A1
20150342661 Ron Edoute Dec 2015 A1
20150366999 Amritphale Dec 2015 A1
20160038753 Chornenky Feb 2016 A1
20160051827 Ron Edoute Feb 2016 A1
20160074670 Mohamed Mar 2016 A1
20160121135 Pilla May 2016 A1
20160129273 Park May 2016 A1
20160129274 Park May 2016 A1
20160145571 Giampapa May 2016 A1
20160220083 Thorne Aug 2016 A1
20160228721 Mohamed Aug 2016 A1
20160228723 Mohamed Aug 2016 A1
20160346561 Ron Edoute Dec 2016 A1
20160372362 Signamarcheix Dec 2016 A1
20170001201 Baym Jan 2017 A1
20170043177 Ron Edoute Feb 2017 A1
20170050019 Ron Edoute Feb 2017 A1
20170071977 Mohamed Mar 2017 A1
20170072210 Gangwish Mar 2017 A1
20170080245 Dimino Mar 2017 A1
20170087367 Weisend Mar 2017 A1
20170113060 Anderson Apr 2017 A1
20170151442 Walborn Jun 2017 A1
20170157318 Balakrishnan Jun 2017 A1
20170165496 Pilla Jun 2017 A1
20170175521 Pirolli Jun 2017 A1
20170189710 Goetz Jul 2017 A1
20170225004 Casse Aug 2017 A1
20170266459 Mohamed Sep 2017 A1
20170304642 Ron Edoute Oct 2017 A1
20170354830 Moffett Dec 2017 A1
20180001102 Henry Jan 2018 A1
20180028831 Ron Edoute Feb 2018 A1
20180043172 Serrano Carmona Feb 2018 A1
20180043174 Gurfein Feb 2018 A1
20180071140 Sheydin Mar 2018 A1
20180104484 Ryaby Apr 2018 A1
20180110960 Youngblood Apr 2018 A1
20180126185 Hochstenbach May 2018 A1
20180133498 Chornenky May 2018 A1
20180140861 Dimino May 2018 A1
20180200503 Ryaby Jul 2018 A1
20180200531 Pilla Jul 2018 A1
20180207439 Cook Jul 2018 A1
20180272149 Anderson Sep 2018 A1
20180318598 Russo Nov 2018 A1
20180361144 Omar-Pasha Dec 2018 A1
20190021277 Godfrey Jan 2019 A1
20190054308 Verma Feb 2019 A1
20190082990 Poltorak Mar 2019 A1
20190091474 Zeng Mar 2019 A1
20190126036 Franco-Obregon May 2019 A1
20190201280 Bak Jul 2019 A1
20190217090 Ryaby Jul 2019 A1
20190247662 Poltroak Aug 2019 A1
20190255363 Gangwish Aug 2019 A1
20190290925 Gellman Sep 2019 A1
20190296589 Ardavan Sep 2019 A1
20190299018 Chornenky Oct 2019 A1
20190323345 Pirolli Oct 2019 A1
20190329065 Gandel Oct 2019 A1
20190336782 Shealy Nov 2019 A1
20190343702 Smith Nov 2019 A1
20190351249 Pilla Nov 2019 A1
20190365803 Melosh Dec 2019 A1
20190381331 Gleim Dec 2019 A1
20190388676 Babico Dec 2019 A1
20200001101 Moffett Jan 2020 A1
20200016422 Ron Edoute Jan 2020 A1
20200016423 Ron Edoute Jan 2020 A1
20200069960 Walborn Mar 2020 A1
20200077942 Youngblood Mar 2020 A1
20200094066 Heath Mar 2020 A1
20200094068 Dimino Mar 2020 A1
20200171318 Dimino Jun 2020 A1
20200206523 Kirk Jul 2020 A1
20200238098 Chornenky Jul 2020 A1
20200276435 Ryaby Sep 2020 A1
20200285131 Marandi Sep 2020 A1
20200289841 McIntyre Sep 2020 A1
20200306554 Ron Edoute Oct 2020 A1
20200353274 Ansari Nov 2020 A1
Foreign Referenced Citations (14)
Number Date Country
1483487 Mar 2004 CN
1723985 Mar 2008 EP
100846091 Jul 2008 KR
2004011631 Feb 2004 WO
2004103098 Dec 2004 WO
2010124234 Oct 2010 WO
2011011748 Jan 2011 WO
2012033932 Mar 2012 WO
2012045079 Apr 2012 WO
2015161063 Oct 2015 WO
2016081952 May 2016 WO
2018075394 Apr 2018 WO
2020041502 Feb 2020 WO
202118341 Sep 2021 WO
Non-Patent Literature Citations (33)
Entry
International Search Report for PCT/US21/30826, dated Sep. 8, 2021.
Written Opinion of the International Search Authority for PCT/US21/30826, dated Sep. 8, 2021.
Anthony J. Lisi et al., “A Pulsed Electromagnetic Field Therapy Device for Non-Specific Low Back Pain: A Pilot Randomized Controlled Trial”, Mar. 12, 2019, Pain Ther (2019) 8:133-140.
Sujith Vijayan et al., “Thalamic model of awake alpha oscillations and implications for stimulus processing”, PNAS Nov. 6, 2012 109 (45) 18553-18558.
Mingke Jiao et al., “Effects of Low-Frequency Pulsed Electromagnetic Fields on High-Altitude Stress Ulcer Healing in Rats”, Hindawi BioMed Research International, vol. 2019, Article ID 6354054, 8 pages.
Maria Vadala et al., “Mechanisms and therapeutic effectiveness of pulsed electromagnetic field therapy in oncology”, Cancer Medicine 2016; 5(11):3128-3139.
Renate Gehwolf et al., “Global Responses of II-1β-Primed 3D Tendon Constructs to Treatment with Pulsed Electromagnetic Fields”, Published: Apr. 30, 2019, Cells 2019, 8(5), 399.
Pierre Le Chapellier et al., “Cellular Perception and Static Magnetic Fields Active Penetration Depth for Pain Magnetotherapy”, Piers Online, vol. 6, No. 3, 2010.
Tommaso Iannitti et al., “Pulsed electromagnetic field therapy for management of osteoarthritis-related pain, stiffness and physical function: clinical experience in the elderly”, Published Sep. 26, 2013, Clinical Interventions in Aging 2013:8 1289-1293.
Yvan Touitou et al., “The effects of extremely low-frequency magnetic fields on melatonin and cortisol, two marker rhythms of the circadian system”, Dialogues in Clinical Neuroscience—vol. 14. No. 4. 2012.
Alanna V Van Huizen et al., “Weak magnetic fields alter stem cell-mediated growth”, Sci Adv. Jan. 30, 2019;5(1):eaau7201.
Wenjun Xu et al., “Effect of pulsed millisecond current magnetic field on the proliferation of C6 rat glioma cells”, Electromagnetic Biology and Medicine, 2019, vol. 38, No. 3, 185-197.
Peter Kovacic et al., “Electromagnetic fields: mechanism, cell signaling, other bioprocesses, toxicity, radicals, antioxidants and beneficial effects”, Journal of Receptors and Signal Transduction, 2010; 30(4): 214-226.
Connie X. Wang et al., “Transduction of the Geomagnetic Field as Evidenced from alpha-Band Activity in the Human Brain”, eNeuro, Mar./Apr. 2019, 6(2) e0483-18.2019 1-23.
Christina L. Ross et al., “Targeting Mesenchymal Stromal Cells/Pericytes (MSCs) With Pulsed Electromagnetic Field (PEMF) Has the Potential to Treat Rheumatoid Arthritis”, Mar. 4, 2019, Frontiers in Immunology, vol. 10: Article 266.
Rachel Lai-Chu Kwan et al., “Efficacy of Biophysical Energies on Healing of Diabetic Skin Wounds in Cell Studies and Animal Experimental Models: A Systematic Review”, Jan. 16, 2019, Int. J. Mol. Sci. 2019, 20(2), 368.
Masoomeh Kazemi et al., “Effects of the Extremely Low Frequency Electromagnetic Fields on NMDA-Receptor Gene Expression and Visual Working Memory in Male Rhesus Macaques”, May, Jun. 2018, Basic and Clinical Neuroscience, 9(3), 167-176.
Yue Li et al., “Effects of pulsed electromagnetic fields on learning and memory abilities of STZ-induced dementia rats”, Mar. 17, 2019, Electromagnetic Biology and Medicine, 38:2, 123-130.
Igor Jerman et al., “Enhancing Vigilance by Low Intensity Transcranial Pulsed Magnetic Stimulation Applying the Entrainment Model”, Oct. 17, 2019, Open Access Library Journal, 6: e5782.
Igor Jerman et al., “Influencing Relaxation by a Low Intensity Transcranial Pulsed Magnetic Stimulation Applying the Entrainment Model”, Sep. 17, 2019, Open Access Library Journal, 6: e5741.
Laura Baker-Price et al., “Intermittent Burst-Firing Weak (1 Microtesla) Magnetic Fields Reduce Psychometric Depression in Patients who Sustained Closed Head Injuries: A Replication and Electroencephalographic Validation”, Perceptual and MotorSkils, 2003,96,965-974.
Kalina Makowiecki et al., “Low-intensity repetitive transcranial magnetic stimulation requires concurrent visual system activity to modulate visual evoked potentials in adult mice”, Apr. 11, 2018, Scientific Reports, vol. 8, Article No. 5792 (2018).
John A. Robertson, “Magnetic Field Effects on the Neuroprocessing of Pain”, Aug. 2011, Electronic Thesis and Dissertation Repository, Paper 236.
Mahtab Roohi-Azizi et al., “Changes of the brain's bioelectrical activity in cognition, consciousness, and some mental disorders”, Med J Islam Repub Iran. 2017(Sep. 3); 31.53.
G. Bard Ermentrout et al., “Modeling neural oscillations”, Sep. 6, 2002, Physiology & Behavior 77 (2002) 629-633.
Nermeen Mohamed Abdelhalim et al., “Short-Term impacts of pulsed electromagnetic field therapy in middle-aged university's employees with non-specific low back pain: A pilot study”, Pak J Med Sci. 2019; 35(4):987-991.
Rachel Lai-Chu Kwan et al., “Pulsed Electromagnetic Field Therapy Promotes Healing and Microcirculation of Chronic Diabetic Foot Ulcers: A Pilot Study”, May 2015, Advances in Skin & Wound Care, vol. 28, No. 5.
Magor L. Lörincz et al., “Temporal Framing of Thalamic Relay-Mode Firing by Phasic Inhibition during the Alpha Rhythm”, Neuron. Sep. 10, 2009; 63(5): 683-696.
Chul-Ho Kim et al., “The impact of pulsed electromagnetic field therapy on blood pressure and circulating nitric oxide levels: a double blind, randomized study in subjects with metabolic syndrome”, Aug. 8, 2019, Blood Pressure, 29:1, 47-54.
International Search Report for PCT/US20/31467, dated Aug. 31, 2020.
Written Opinion of the International Search Authority for PCT/US20/31467, dated Aug. 31, 2020.
OmniPENF—OmniPENF Distibutors; Become an Authorized Distributor. Contact page [online]. Cell Technologies, Inc.; Aug. 22, 2018 [retrieved on Feb. 2, 2022]. Retrieved from the Internet: <URL:https://web.archive.org/web/20180822093113/https://omnipemf.com/>.
OSKA Pulse Buy Now/How It Works; Doctor Recommended OSKA Pulse Clinically Proven Pain Relief. Purchase Page [online], Oska Wellness; Apr. 5, 2019 [retrived on Feb. 4, 2022], Retrieved from the Internet: <URL:https://web.archive.org/web/20190405101216/https://www.oskawellness.com/>.
Related Publications (1)
Number Date Country
20200353274 A1 Nov 2020 US
Provisional Applications (2)
Number Date Country
62892751 Aug 2019 US
62843727 May 2019 US