Bioelectronics Corp (BIEL)

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Bioelectronics : "Pulsed Electromagnetic Field Device with Adhesive Applicator" in Patent Application Approval Process

09/17/2014 | 11:03pm US/Eastern

http://www.4-traders.com/BIOELECTRONICS-CORP-130840/news/Bioelectronics--Pulsed-Electromagnetic-Field-Device-with-Adhesive-Applicator-in-Patent-Applicatio-19065443/

By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- A patent application by the inventor Martinez, John Robert (Woodsboro, MD), filed on October 22, 2012, was made available online on September 11, 2014, according to news reporting originating from Washington, D.C., by NewsRx correspondents (see also Bioelectronics Corp.).

This patent application is assigned to Bioelectronics Corp.

The following quote was obtained by the news editors from the background information supplied by the inventors: "Applying an electromagnetic field to injured bodily tissue has been shown to promote therapeutic healing. In particular, application of a high-frequency electromagnetic field at a sufficiently low field strength so as not to produce tissue heating has been shown to promote a beneficial effect on healing of the tissue. In some cases, effectiveness of the therapeutic effect of the electromagnetic field has been improved by reducing the power requirements of the applied field and extending the treatment duration."

In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventor's summary information for this patent application: "The following description relates to an electromagnetic field radiator that influences the metabolic characteristics of living systems. The systems and techniques may be used to therapeutically promote healing of tissue and treat diseases.

"In one aspect, a device includes a pulsed electromagnetic field device and an applicator. The pulsed electromagnetic field device includes an electromagnetic field generator, a power source coupled to the electromagnetic field generator, a single-turn loop antenna coupled to the electromagnetic field generator and arranged to radiate an electromagnetic field, and an activator configured to initiate radiation of the electromagnetic field. The applicator includes a flexible substrate defining an opening, an adhesive composition supported by a first surface of the flexible substrate, and a therapeutic substance supported by the first surface of the flexible substrate. The applicator is configured to adhere the pulsed electromagnetic field device to a human body with the adhesive composition such that the therapeutic substance contacts a first portion of the body, a second portion of the body is exposed to air through the opening defined by the flexible substrate, and the radiated electromagnetic field impinges on bodily tissue proximate the first portion and the second portion of the body.

"In another general aspect, a device includes a pulsed electromagnetic field device and an applicator. The pulsed electromagnetic field device includes an electromagnetic field generator, a power source coupled to the electromagnetic field generator, a single-turn loop antenna coupled to the electromagnetic field generator and arranged to radiate an electromagnetic field, and an activator configured to initiate radiation of the electromagnetic field. The applicator includes a flexible substrate defining an opening and an adhesive composition supported by a first surface of the flexible substrate. The applicator is configured to adhere the pulsed electromagnetic field device to a surface with the adhesive composition such that a portion of the surface is exposed to air through the opening defined by the flexible substrate. The surface to which the pulsed electromagnetic field device is adhered may be, for example, bodily tissue (e.g., a human body) or an article of clothing intended to be worn close to the surface of the body.

"In another general aspect, a kit includes a pulsed electromagnetic field device, an applicator, and instructions for adhering the pulsed electromagnetic field device to a human body with the applicator. The pulsed electromagnetic field device includes an electromagnetic field generator, a power source coupled to the electromagnetic field generator, a single-turn loop antenna coupled to the electromagnetic field generator and arranged to radiate an electromagnetic field, and an activator configured to initiate radiation of the electromagnetic field. The applicator includes a flexible substrate defining an opening, an adhesive composition supported by a first surface of the flexible substrate, a therapeutic substance supported by the first surface of the flexible substrate, and a release liner in contact with the adhesive composition. The instructions describe adhering the pulsed electromagnetic field device to a human body with the applicator such that therapeutic substance contacts a first portion of the body and a second portion of the body is exposed to air through the opening defined by the flexible substrate. The instructions also describe how to initiate radiation of the electromagnetic field. The radiated electromagnetic field impinges on bodily tissue proximate the first portion and the second portion of the body.

"Another general aspect includes providing a pulsed electromagnetic field device and an applicator. The applicator includes a flexible substrate defining an opening, an adhesive composition supported by a first surface of the flexible substrate, a therapeutic substance supported by the first surface of the flexible substrate, and a release liner in contact with the adhesive composition. The release liner is removed from the adhesive composition, and the opening defined by the flexible substrate is aligned with an opening defined by the pulsed electromagnetic field device. The pulsed electromagnetic field device is contacted with the adhesive composition supported by the first surface of the flexible substrate, and the pulsed electromagnetic field device is affixed to a human body with the applicator such that the therapeutic substance contacts a first portion of the human body and a second portion of the human body is exposed to air through the opening defined by the flexible substrate. The pulsed electromagnetic field device is caused to radiate an electromagnetic field that impinges on the human body.

"Another general aspect includes providing a pulsed electromagnetic field device fixed in an applicator, removing a release liner from the applicator, affixing the applicator to a human body, and causing the pulsed electromagnetic field device to radiate an electromagnetic field that impinges on the human body. The applicator defines an opening and includes an adhesive composition supported by a first surface of the applicator, a therapeutic substance supported by the first surface of the applicator, and a release liner in contact with the adhesive composition. The therapeutic substance contacts a first portion of the human body and a second portion of the human body is exposed to air through the opening defined by the applicator.

"Another general aspect includes positioning a pulsed electromagnetic field device and an applicator proximate a human body, affixing the pulsed electromagnetic field device to the human body with the applicator such that the therapeutic substance contacts a first portion of the human body and a second portion of the human body is exposed to air through the opening defined by the flexible substrate, and causing the pulsed electromagnetic field device to radiate an electromagnetic field that impinges on the human body. The applicator includes a flexible substrate defining an opening, an adhesive composition supported by a first surface of the flexible substrate, and a therapeutic substance supported by the first surface of the flexible substrate.

"Another general aspect includes positioning a pulsed electromagnetic field device fixed in an applicator proximate a human body, affixing the applicator to the human body such that the therapeutic substance contacts a first portion of the human body and a second portion of the human body is exposed to air through the opening defined by the flexible substrate, and causing the pulsed electromagnetic field device to radiate an electromagnetic field that impinges on the human body. The applicator includes a flexible substrate defining an opening, an adhesive composition supported by a first surface of the flexible substrate, and a therapeutic substance supported by the first surface of the flexible substrate.

"Another general aspect includes adhering a pulsed electromagnetic field device to an article of clothing with an applicator, causing the pulsed electromagnetic field device to radiate an electromagnetic field, and dressing a human body with the article of clothing, such that the pulsed electromagnetic field device is proximate the human body and the radiated electromagnetic field impinges on the human body.

"Implementations of all of the above general aspects may include one or more of the following features as applicable. In some cases, a release liner is in contact with the adhesive composition. The adhesive may be non-toxic and/or hypoallergenic and/or FDA-approved. For example, the adhesive can be a pharmaceutical grade adhesive. In some cases, the adhesive composition includes the therapeutic substance. The adhesive composition may also include one or more additives, such as an antibacterial or antimicrobial additive, a hydrogel, etc. In certain cases, the therapeutic substance and/or one or more additives may be applied as separate layers on the flexible substrate rather than (or together with) being mixed in with the adhesive composition.

"The therapeutic substance may be a topical rubefacient. The rubefacient may include, for example, a salicylate, a nicotinate ester, capsaicin, isopropanol, menthol, or a combination thereof. In some cases, the rubefacient includes an extract or oil of cloves, garlic, ginger, horseradish, mustard, nettle, rosemary, rue, or a combination thereof. The therapeutic substance may have analgesic properties, anti-inflammatory properties, anesthetic properties, or a combination thereof. In certain cases, the duration of the electromagnetic field radiation exceeds the duration of efficacy of the therapeutic substance (i.e., the pulsed electromagnetic field device is still operating after the effects of the therapeutic substance have worn off).

"In another aspect, a device for applying a therapeutic electromagnetic field is disclosed including an electromagnetic field generator, which is coupled to an antenna that is arranged to radiate the electromagnetic field. A power source is coupled to the generator to provide power for the device and an activator is used to initiate radiation of the electromagnetic field. The therapeutic device is self-contained and portable and is disposed over a surface of bodily tissue such that the radiated electromagnetic field impinges upon the bodily tissue.

"In an implementation, the power source is a battery of less than approximately 10 VDC. In another implementation, the device is a component of a therapeutic delivery system. The therapeutic delivery system includes a member from the group of a patch, a bandage, a pad, a brace, a strap, tape, adhesive and a cast.

"In another aspect, a technique for applying a therapeutic electromagnetic field is facilitated by incorporating a power source, antenna and electromagnetic field generator within a portable and disposable package and affixing the device to bodily tissue. The device generates an electromagnetic field that induces an alternating current in the bodily tissue. In another implementation, the average available radiated power is less than approximately 1 milliwatt and the peak available radiated power density is less than 100 microwatts per square centimeter measured substantially at the surface of the tissue.

"Some implementations of the systems and techniques described herein may provide one or more of the following advantages. The device may be suitable for prolonged use. The self-contained unit can encourage patient compliance. In some implementations the device may be placed directly over bodily tissue to provide electromagnetic therapy to the tissue. The device may be part of a therapeutic agent delivery system such as a patch, bandage, pad, brace, cast, or other tissue injury support device.

"In another aspect, a method is disclosed for inducing electrical current in a bodily tissue by: (1) positioning a device described herein adjacent a bodily tissue of an individual; and (2) operating the device for a duration, at a frequency, and at a peak available radiated power density effective to induce electrical current in the bodily tissue, wherein the device is positioned relative to the individual such that the device induces electrical current in the bodily tissue without making conductive contact with the bodily tissue. In some embodiments, the induction of electrical current in the bodily tissue reduces or eliminates a pain sensation in the individual.

"In another aspect, a method is disclosed for treating an individual by: (1) positioning a device described herein adjacent a bodily tissue of an individual; and (2) operating the device for a duration, at a frequency, and at a peak available radiated power density effective to elicit a therapeutic response in the individual, wherein the device is positioned relative to the individual such that the device induces electrical current in a bodily tissue of the individual without making conductive contact with the bodily tissue.

"In another aspect, a method is disclosed for treating an individual by: (1) providing a device containing an electromagnetic field generator; (2) positioning the device adjacent a bodily tissue of an individual; and (3) operating the device for a duration, at a frequency, and at a peak available radiated power density effective to elicit a therapeutic response in the individual, wherein the device is positioned relative to the individual such that the device induces electrical current in the bodily tissue of the individual without making conductive contact with the bodily tissue, and wherein the device effects a penetration of the induced current into the bodily tissue such that the therapeutic response is elicited at a depth of at least 2 cm in the bodily tissue. In some embodiments, the therapeutic response is elicited at a depth of at least 3, 4, 5, or 6 cm in the bodily tissue. In other embodiments, the therapeutic response is elicited at a depth of 2 to 3, 2 to 4, 2 to 5, 2 to 6, 3 to 4, 3 to 5, or 3 to 6 cm in the bodily tissue.

"In another aspect, a method is disclosed for treatment by: (1) providing a device selected from the group consisting of a pulsed electromagnetic field therapy (PEMF) apparatus, a transcutaneous electrical neural stimulator, and a static magnet array; (2) positioning the device at a distance from an individual effective to elicit a therapeutic response in the individual, wherein the device is positioned at a bodily location selected from the group consisting of the external end of the elbow transverse crease, the depression at the lower border of the malleolus lateralis, below the lateral extremity of the clavicle at the level of the first intercostals space, between the fourth lumbar vertebra and the fifth lumbar vertebra or 1 inch to the right or left thereof horizontally, a depression anterior or inferior to the head of the fibula, about 1.5 inches above the medial border of the patella, and between the radius and the palmaris longus; and (3) maintaining the device at the bodily location for a duration effective to elicit the therapeutic response.

"In the methods described herein, positioning a device adjacent a bodily tissue of an individual refers to placing the device close to the skin of the individual (e.g., within 0.5, 1, 2, 3, 4, 5, or 6 inches of the skin) or in contact with the skin. The device can be encapsulated in a material and still be considered adjacent a bodily tissue, so long as it operates in the manner described herein. The methods do not entail penetration of the skin by the device and/or the application of electrodes to the skin (e.g., the device induces current in a bodily tissue in the absence of an application of electrodes to the skin). Tissues that can receive the electrical current according to the methods described herein include, for example, the skin as well as tissues that underlay the skin (e.g., joints or bones).

"An exemplary device for use in the methods described herein comprises: an electromagnetic field generator; an antenna coupled to the generator and arranged to radiate the electromagnetic field; a power source (e.g., a battery) coupled to the generator; and an activator to initiate radiation of the electromagnetic field, wherein the device is self-contained and portable. The antenna can optionally contain antenna conductors on a printed circuit board. In some embodiments, the device additionally contains: an annular ring to surround the battery; and a wire wound around the annular ring. In some embodiments, the annular ring has a stepped cross-section and a wire wound on a top and outer side of the annular ring coupled to the antenna conductors. In some embodiments, the annular ring contains a ferrite ring. In some embodiments, the annular ring contains an insulating-magnetic ring.

"The current induced in the bodily tissue of an individual can be, for example, parallel or perpendicular to the direction of antenna conductors.

"In some embodiments of the methods described herein, the frequency is 27+/-0.5 MHz (e.g., 27.1 MHz).

"In some embodiments of the methods described herein, the peak available radiated power density is less than 100 microwatts per square centimeter measured at the surface of the bodily tissue (e.g., the skin of the individual).

"The device used in the methods can optionally contain a delivery system, e.g., a patch, bandage, pad, brace, strap, tape, adhesive, or cast. In some embodiments the delivery system is a single use adhesive bandage.

"The methods described herein can additionally include pulsing the generated electromagnetic field. In addition, the methods can also include altering at least one of a duty-cycle and a pulse repetition rate of the pulsed electromagnetic field. In some embodiments, the duty cycle is approximately 8%-10%.

"In some embodiments, the individual has a pain-related disorder and the therapeutic response includes a reduction or elimination of pain in the individual. Examples of pain-related disorders include, for example, pain response elicited during tissue injury (e.g., inflammation, infection, and ischemia), pain associated with musculoskeletal disorders (e.g., joint pain such as that associated with arthritis, toothache, and headaches), pain associated with surgery, pain related to irritable bowel syndrome, and chest pain.

"In some embodiments, the individual has a disorder selected from the group consisting of adhesive capsulitis, tennis elbow, osteoarthritis, back pain, multiple sclerosis, tendon inflammation, and carpal tunnel syndrome, and the therapeutic response includes a reduction or elimination of pain associated with the disorder.

"In some embodiments, the individual has a bone, joint, soft-tissue, or connective tissue disorder and the therapeutic response includes a reduction or elimination of inflammation in a bone, joint, soft-tissue, or connective tissue of the individual. In some embodiments, the individual has a bone, joint, soft-tissue, or connective tissue disorder and the therapeutic response includes a reduction or elimination of pain associated with the disorder.

"In some embodiments, the individual has a dental condition, and the therapeutic response includes a reduction or elimination of pain associated with the condition.

"In some embodiments, the individual has an arthritic disorder and the therapeutic response includes a reduction or elimination of pain associated with the disorder. In an example, the disorder is osteoarthritis of the knee and the therapeutic response includes a reduction or elimination of pain of the knee.

"Details of one or more implementations are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

"FIG. 1 is an implementation of a therapeutic electromagnetic device depicting an arrangement of the components.

"FIG. 2 is an implementation of a therapeutic electromagnetic patch depicting components in layers.

"FIG. 3 is a block diagram of an implementation of a therapeutic electromagnetic device.

"FIGS. 4A-B illustrate a control waveform and resulting RF waveform.

"FIGS. 5A-I illustrate antenna configurations.

"FIG. 6 depicts an annular electromagnetic device adhered to bodily tissue.

"FIGS. 7A-D depict various applications of a PEMF device.

"FIGS. 8 and 8A depict an enhanced antenna.

"FIG. 9 depicts anatomical locations for placement of a therapeutic device.

"FIG. 10A depicts a PEMF device with a single-turn loop antenna.

"FIG. 10B depicts an applicator for adhering the PEMF device of FIG. 10A.

"FIG. 10C shows the PEMF device of FIG. 10A adhered to the applicator of FIG. 10B.

"FIG. 10D depicts the PEMF device of FIG. 10A adhered to a human body with the applicator of FIG. 10B.

"FIG. 10E is a side view of the applicator shown in FIG. 10C aligned above the PEMF device of FIG. 10A.

"FIG. 10F depicts the applicator of FIG. 10C in contact with the PEMF device of FIG. 10A.

"FIG. 10G depicts the PEMF device of FIG. 10A adhered to a surface with the applicator of FIG. 10C.

"FIG. 10H depicts the PEMF device of FIGS. 10A and 10B fixed in an applicator prior to application to a surface.

"FIG. 10I depicts the PEMF device of FIG. 10H adhered to a surface.

"FIG. 11A depicts a front view of a PEMF device with a single-turn loop antenna.

"FIG. 11B depicts the PEMF device of FIG. 11A adhered to an applicator prior to application to a surface.

"FIG. 12A depicts a kit including a PEMF device, an applicator, and instructions for use.

"FIG. 12B depicts a kit including a PEMF device fixed in an applicator and instructions for use.

"FIGS. 13A-13E are flow charts describing application of a PEMF device to a surface with an applicator.

"Like reference symbols in the various drawings indicate like elements."

URL and more information on this patent application, see: Martinez, John Robert. Pulsed Electromagnetic Field Device with Adhesive Applicator. Filed October 22, 2012 and posted September 11, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1200&p=24&f=G&l=50&d=PG01&S1=20140904.PD.&OS=PD/20140904&RS=PD/20140904

Keywords for this news article include: Bioelectronics Corp., Bone Research, Electromagnet, Electronics, Inflammation, Legal Issues, Therapeutics, Therapy.

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