WO2023281448A1 - Appareil à usage esthétique utile pour accroître le rajeunissement de la peau et méthodes associées - Google Patents
Appareil à usage esthétique utile pour accroître le rajeunissement de la peau et méthodes associées Download PDFInfo
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- WO2023281448A1 WO2023281448A1 PCT/IB2022/056307 IB2022056307W WO2023281448A1 WO 2023281448 A1 WO2023281448 A1 WO 2023281448A1 IB 2022056307 W IB2022056307 W IB 2022056307W WO 2023281448 A1 WO2023281448 A1 WO 2023281448A1
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- A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
- A61N2005/0659—Radiation therapy using light characterised by the wavelength of light used infrared
Definitions
- This invention generally relates to a device used to improve skin viability and skin rejuvenation, and a method of using the device.
- the chemical peel approach usually involves injury to the outermost layer of the skin – the epidermis – which may cause discoloration. Since collagen fibers are found in the dermis – the subcutaneous layer of the skin, and since heat was shown to contract these fibers and stimulate their production [Zelickson BD, Kist D, Bernstein E, Brown DB, Ksenzenko S, Burns J, Kilmer S, Mehregan D, Pope K. Histological and ultrastructural evaluation of the effects of a radiofrequency-based nonablative dermal remodeling device: a pilot study. Arch Dermatol.2004 Feb;140(2):204-9], methods of differentially heating the dermis (deep tissue diathermy) have recently arisen.
- PEMF Pulsed Electromagnetic Fields
- ELF extremely low frequencies
- RF radiofrequencies
- PEMF works in few ways. Due to the radiation absorbed in the tissue, it can be heated to various temperatures, depending on the power applied, the frequency transmitted, and more importantly the tissue characteristics. Eventually, the tissue can be warmed to denaturation temperatures, which cause coagulation necrosis and tissue damage. It can also be heated to lower temperatures, which proved to result in the afore-mentioned contraction of collagen fibers.
- Another modus operandi involves non thermal effects.
- Angiogenesis the sprouting of new blood vessels, increases blood flow to the tissue, which in turn increases oxygen and nutritional substances delivery to the tissue. This enhanced anabolic effect is most beneficial for an injured tissue, promoting rapid and improved healing. The growth factor released further enhances the healing process, both in quality and time of improvement.
- the effect of PEMF on tissues was utilized in various applications. For example, US20050182462A1 discloses healthy deep tissue heating using PEMF for the purpose of causing contraction and tightening of the skin. [0013] PEMF has also been used to improve skin wound healing.
- WO08064272 discloses a method of treating a severe diabetic ulcer using PEMF.
- the patent also discloses the addition of intermittent compression therapy (ICT) and the use of low intensity ultrasound (up to 50 W/cm 2 ), the latter aimed at inhibiting microbial growth.
- ICT intermittent compression therapy
- WO98005380 discloses a method of tightening skin using an RF electromagnetic energy delivery device.
- Improving the results of skin tightening based on dermis diathermy is still a long felt need.
- PEMF pulsed electromagnetic field
- a deep tissue diathermy device (4) for constantly applying heat to said region of a patient's skin up to temperature T;
- said system (10) is adapted for simultaneously applying heat and PEMF to said region of a patient's skin; wherein application of said system increases said skin rejuvenation such that said skin rejuvenation increase (SRI) is greater than the sum of said SRI provided by electromagnetic pulses increase and said SRI provided by said deep tissue diathermy device increase.
- SRI skin rejuvenation increase
- said electromagnetic pulse is square shaped at a frequency of 16 Hz, duration of about 5 milliseconds and intensity of 12 Gauss.
- said deep tissue diathermy device (4) is selected from any device emitting RF radiation or any means adapted for producing electrical current absorbed by subcutaneous tissue (e.g., subcutaneous fat).
- said deep tissue diathermy device (4) additionally comprises: a. at least one electrical output device adapted to generate RF electromagnetic energy; b.
- said deep tissue diathermy device (4) additionally comprises: a. at least one electrical output device adapted to generate electrical current; b. at least two electrodes electrically coupled to said electrical output device and placed on said skin region, wherein all said electrodes are adapted to simultaneously apply said electrical current to said skin region.
- said system additionally comprising a control system (6) adapted to regulate said electromagnetic pulses and/or said electromagnetic pulses.
- said pulsed electromagnetic frequency generator is adapted to provide a dynamic magnetic field such that said pulses vary with time.
- the magnetic field intensity B of each pulse applied by said pulsed electromagnetic frequency generator (2) ranges between about 0 and about 3 Tesla.
- the duration of each pulse applied by said pulsed electromagnetic frequency generator (2) ranges between about 3 and about 1000 milliseconds.
- the frequency F applied by the pulses of said pulsed electromagnetic frequency generator (2) ranges between about 1 Hz and about 1M Hz.
- the power applied by the RF electrode ranges between about 1 and about 150 watts per pulse.
- said deep tissue diathermy device (4) is selected in a non-limiting manner from a group consisting of an ultrasonic diathermy, an optical device, electromagnetic induction, sound waves emitting instrument, direct heat applying instrument, or from any other means of heating subcutaneous tissue to temperature T.
- said power supply and control system (6) additionally comprising: a. processing means, adapted to store in a communicable database predetermined parameters defining (i) safe treatment parameters and (ii) unsafe treatment parameters; said parameters are selected from a group consisting of time t of said treatment, temperature T of said tissue, ratio t/T, Frequency F, power P, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), treatment depth, superficial muscle contractions or a combination thereof; b.
- processing means adapted to store in a communicable database predetermined parameters defining (i) safe treatment parameters and (ii) unsafe treatment parameters; said parameters are selected from a group consisting of time t of said treatment, temperature T of said tissue, ratio t/T, Frequency F, power P, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (S
- sensing means adapted to sense electromagnetic radiation and heat radiation parameters selected from a group consisting of time t of time t of said treatment, temperature T of said tissue, ratio t/T, Frequency F, power P, Intensity I of said ultrasound irradiation, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), treatment depth, superficial muscle contractions or a combination thereof; c. regulating means, adapted to allow said electromagnetic radiation and heat radiation if said parameters are within said safe treatment parameters and to stop the electromagnetic radiation if the radiation parameters are in said unsafe treatment parameters.
- the method comprises steps selected inter alia from: a. obtaining (i) pulsed electromagnetic frequency generator; and, (ii) a deep tissue diathermy device; b.
- parameters defining (i) safe treatment parameters and (ii) unsafe treatment parameters; said parameters are selected from a group consisting of time t of said treatment, temperature T of said tissue, ratio t/T, Frequency F, power P, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), treatment depth, superficial muscle contractions or a combination thereof; b.
- electromagnetic radiation and heat radiation parameters selected from a group consisting of time t of said treatment, temperature T of said tissue, ratio t/T, Frequency F, power P, Intensity I of said ultrasound irradiation, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), treatment depth, superficial muscle contractions or a combination thereof; c. allowing said electromagnetic radiation and said heat radiation if parameters within said safe treatment parameters and to stop the electromagnetic radiation if the radiation parameters are in said unsafe treatment parameters.
- step of applying heat to a subcutaneous tissue additionally comprising steps of a. obtaining at least one electrical output device adapted to generate RF electromagnetic energy; b. electrically coupling at least two electrodes to said electrical output device; c. placing said at least two electrodes on said skin region; and, d. simultaneously applying via all said electrodes said RF energy to said skin region.
- IEC selected from a group consisting of IEC 60601-2-35, IEC 60601-2-33, IEC 60601-2-29, IEC 60601-2-9, IEC 60601- 2-5, IEC 60601-2-3, IEC 60601-1-8, IEC 60601-1-6, IEC 60601-1-4, IEC 60601-1-3, IEC 60601-1-2, IEC 60601-1-1 or any combination thereof.
- processing means adapted to store in a communicable database predetermined parameters defining (i) safe treatment parameters and (ii) unsafe treatment parameters; said parameters are selected from a group consisting of time t of said treatment, temperature T of said tissue, ratio t/T, Frequency F, power P, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), treatment depth, superficial muscle contractions or a combination thereof; b.
- sensing means adapted to sense electromagnetic radiation and heat radiation parameters selected from a group consisting of time t of time t of said treatment, temperature T of said tissue, ratio t/T, Frequency F, power P, Intensity I of said ultrasound irradiation, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), treatment depth, superficial muscle contractions or a combination thereof; c. regulating means, adapted to allow said electromagnetic radiation and heat radiation if said parameters are within said safe treatment parameters and to stop the electromagnetic radiation if the radiation parameters are in said unsafe treatment parameters.
- said integrated system (20) comprises: at least two electrodes (41) adapted to be placed on said region of a patient's skin; each of said electrodes is a least partially coiled via a coil 42; b.
- parameters defining (i) safe treatment parameters and (ii) unsafe treatment parameters; said parameters are selected from a group consisting of time t of said treatment, temperature T of said tissue, ratio t/T, Frequency F, power P, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), treatment depth, superficial muscle contractions or a combination thereof; b.
- electromagnetic radiation and heat radiation parameters selected from a group consisting of time t of said treatment, temperature T of said tissue, ratio t/T, Frequency F, power P, Intensity I of said ultrasound irradiation, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), treatment depth, superficial muscle contractions or a combination thereof; c. allowing said electromagnetic radiation and said heat radiation if parameters within said safe treatment parameters and to stop the electromagnetic radiation if the radiation parameters are in said unsafe treatment parameters.
- step of applying heat is applied for about 0.01 to 60 minutes.
- step of applying heat is applied for about 0.01 to 60 minutes.
- the heat and the pulsed electromagnetic therapy are applied simultaneously, sequentially or separately.
- said method is repeated 1 to 100 times in each treatment.
- said treatment is repeated more than once.
- devices selected from a group consisting of: ultrasonic diathermy, an optical device, electromagnetic induction, sound waves emitting instrument, direct heat applying instrument, or from any other means of heating subcutaneous tissue to temperature T.
- FIGS.1A - 1D schematically present a skin viability improving system (10), comprising a pulsed electromagnetic frequency generator (2) and a deep tissue diathermy device (4).
- FIG.1E is a diagram illustrating an example of electrical current applied by the deep tissue diathermy device (4). The current involves a maximal amplitude of 160 volts, and a frequency close to 1 Hz.
- FIG.2 schematically presents a skin viability improving system (10), comprising a pulsed electromagnetic frequency generator (2), a deep tissue diathermy device (4) and a power supply and control system (6).
- FIG.3 schematically presents square waves at a rate of 16 Hz in duration of about 5 milliseconds in an intensity of 12 Gauss which stimulate angiogenesis.
- FIG.4 schematically presents triangular wave pulses at a frequency of 25 Hz and intensity of 20 Gauss which stimulate collagen production.
- FIGS.5 - 6 illustrate another embodiment of the skin viability improving system (20).
- FIGS.7 - 12 schematically present the methods of improving skin viability (400- 420).
- FIGS.13A1-13C2 are pictures of one patient out of the study group treated with the device of the present invention.
- FIGS.14A1-14C2 are pictures of one patient out of the first control group treated with the device of the present invention on the right side and RF on the left side.
- FIGS.15A1-15C2 are pictures of one patient out of the second control group treated with the device of the present invention on the right side and PEMF on the left side.
- FIGS.16A1-16C2 are pictures of one patient out of the third control group treated with the device of the present invention on the right side. The left side was treated with PEMF followed by RF.
- FIG.17 illustrates another embodiment of the device of the present invention.
- FIG.18 illustrates a cyclic diagram according to an embodiment.
- DETAILED DESCRIPTION OF THE DRAWINGS [0134] The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of said invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, will remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide means and method for increasing the viability of the skin. Yet more the present invention provides means and system for skin tightening and rejuvenation.
- PEMF Pulsed Electromagnetic Fields
- Radio Frequency refers hereinafter in a non-limiting manner to part of the electromagnetic spectrum with frequency range of about 3 Hz to 300 GHz.
- ELF Extremely Low Frequencies
- ELF Extremely Low Frequencies
- collagen refers hereinafter in a non-limiting manner to a long, fibrous structural protein which is a major component of the extracellular matrix that supports most tissues and gives cells structure. It is responsible for skin strength and elasticity, and its degradation leads to wrinkles that accompany aging.
- the term “epidermis” refers hereinafter in a non-limiting manner to the outermost layer of the skin.
- the term “dermis” refers hereinafter in a non-limiting manner to a layer of skin beneath the epidermis that consists of connective tissue, and cushions the body from stress and strain.
- the term “deep tissue diathermy” refers hereinafter in a non-limiting manner to a device which heats tissues beneath the epidermis.
- the term “electric diathermy” refers hereinafter in a non-limiting manner to a device which uses high frequency alternating electric or magnetic fields, sometimes with no electrode or device contact to the skin, to induce gentle deep tissue heating by induction.
- typical electrical parameters may include, in a non limiting manner, frequency of about 1 MHz, energy of about 80 joule per 1 square tissue volume, applied for about 6 seconds.
- the term “ultrasonic diathermy” refers hereinafter in a non-limiting manner to heating of tissues by ultrasound.
- the term “about” refers hereinafter to a range of 25% below or above the referred value.
- the term “physical tissue parameters” refers hereinafter to parameters such as tissue temperature, electric current, tissue impedance, specific absorption rate (SAR), treatment depth and superficial muscle contractions.
- SAR specific absorption rate
- angiogenesis refers hereinafter to the sprouting of new blood vessels.
- the term "square wave” refers hereinafter to a non-sinusoidal waveform named for its triangular shape.
- the term “triangle wave” refers hereinafter to a non-sinusoidal waveform named for its triangular shape.
- the term "International Electrotechnical Commission Standards (IEC) 60601-1” refers hereinafter to a medical electrical equipment standard. More specifically it refers to general requirements for basic safety and essential performance.
- IEC 60601-1-1 refers hereinafter to medical electrical equipment standard. More specifically it refers to general requirements for safety - Collateral standard: Safety requirements for medical electrical systems.
- the IEC 60601-1 set of standards are divided into three distinct areas.
- the first area is the basic standard IEC 60601-1. This is the general requirement for all electrical medical based products.
- the second area is the collateral standards, which cover across the board issues such as combining into a system with other devices, EMC, radiation protection, and programmable electronic medical systems (software, firmware, etc.).
- the standard numbers are IEC 60601-1-1, -1-2, -1-3, and -1-4 respectively.
- the third area is the particular standards that deal with a specific type of medical device.
- the particular standards are identified as IEC 60601-2-XX where XX identifies the particular standard number for the particular type of medical equipment. An example would be IEC 60601-2-3 which is the particular standard for short-wave therapy equipment.
- IEC 60601-1-2 refers hereinafter to medical electrical equipment standard. More specifically it refers to general requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-1-3 refers hereinafter to a medical electrical equipment standard. More specifically it refers to general requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
- IEC 60601-1-4 refers hereinafter to a medical electrical equipment standard. More specifically it refers to general requirements for safety - Collateral Standard: Programmable electrical medical systems.
- IEC 60601-1-6 refers hereinafter to a medical electrical equipment standard. More specifically it refers to general requirements for basic safety and essential performance - Collateral standard: Usability.
- IEC 60601-1-8 refers hereinafter to a medical electrical equipment standard. More specifically it refers to general requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
- IEC 60601-2-3 refers hereinafter to a medical electrical equipment standard. More specifically it refers to particular requirements for the safety of short-wave therapy equipment.
- IEC 60601-2-5" refers hereinafter to a medical electrical equipment standard.
- the term “IEC 60601-2-9” refers hereinafter to a medical electrical equipment. More specifically it refers to particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors.
- the term “IEC 60601-2-29” refers hereinafter to a medical electrical equipment standard. More specifically it refers to particular requirements for the basic safety and essential performance of radiotherapy simulators.
- the term “IEC 60601-2-33” refers hereinafter to a medical electrical equipment standard. More specifically it refers to particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
- the term "IEC 60601-2-35" refers hereinafter to a medical electrical equipment standard. More specifically it refers to particular requirements for the safety of blankets, pads and mattresses intended for heating in medical use.
- the present invention relates to a physical therapeutic methods and systems. In said systems a dynamic magnetic pulse and electromagnetic heating systems are incorporated together to accomplish a physical therapy, epically skin tightening and rejuvenation.
- the present invention provides a system adapted to increase skin rejuvenation of a region of a patient's skin.
- the system comprising in a non-limiting manner the following: a. a pulsed electromagnetic field (PEMF) frequency generator (2) for constantly providing electromagnetic pulses to said region of a patient's skin; and, b.
- PEMF pulsed electromagnetic field
- a deep tissue diathermy device (4) applying heat to said region of a patient's skin up to temperature T;
- the system (10) is adapted for simultaneously apply heat and PEMF to said region of a patient's skin. Furthermore, the system increases the skin rejuvenation such that the increase is greater than the sum of the electromagnetic pulses increase and the deep tissue diathermy.
- the system reduces side effects and/or harmful effects of the electromagnetic pulses and/or said deep tissue diathermy such that said reduction of said side effects and/or said harmful effects is greater than the sum of said reduction of said electromagnetic pulses and/or said reduction of said deep tissue diathermy.
- the system comprising at least two electrodes adapted to be placed on said region of a patient's skin; each of said electrodes is at least partially coiled via a coil. It is emphasized that each of said electrodes is adapted for both (i) providing electromagnetic pulses to said region of a patient's skin; and, (ii) applying heat up to temperature T to said region of a patient's skin. Furthermore, it is emphasized that all of said electrodes are adapted to simultaneously provide electromagnetic pulses to said region of a patient's skin; and, apply heat up to temperature T to said region of a patient's skin.
- FIGS.1A-1D illustrating the system 10 for increasing skin rejuvenation.
- the system comprising a pulsed electromagnetic frequency generator (2) for providing electromagnetic pulses to the region of a patient's skin; and, a deep tissue diathermy device (4) adapted to apply heat to the region of a patient's skin up to temperature T.
- the system increases the skin rejuvenation such that the increase is greater than the sum of the electromagnetic pulses increase and the deep tissue diathermy.
- the present invention relays on 2 effects, the thermal effect and the electromagnetic pulse effect: [0173]
- the thermal effect includes heating the tissue such that when the tissue is heated to a sufficiently high temperature, tissue injury is produced. Furthermore, when heat is generated within the dermis, it usually causes contraction and thickening of collagen fibers. This results in an overall tightened and rejuvenated appearance of the skin.
- Heat within the dermis creates a limited thermal injury. The body's natural response to this injury is to produce collagen at the site of the wound.
- the thermal effect i.e., can be produced by: 1. Optical means (e.g. an optical emitter, an illuminator, etc.) – by emitting light in different wavelengths absorbed by subcutaneous tissue such that said tissue is heated; or 2. Electrical means (e.g., current circuitry, a current generator) – by passing electrical current; or 3. Electromagnetic means (e.g., an electromagnetic emitter, electromagnetic circuitry, induction circuitry, etc.) – by transmitting or inducting (electromagnetic induction) electromagnetic filed on the skin; or 4.
- Optical means e.g. an optical emitter, an illuminator, etc.
- Electrical means e.g., current circuitry, a current generator
- Electromagnetic means e.g., an electromagnetic emitter, electromagnetic circuitry, induction circuitry, etc.
- Sound waves e.g., an acoustic emitter
- Physical means e.g., an applicator such as a massager, a topical application
- the electromagnetic pulses may start natural healing processes which usually occur in response to an injury (especially, angiogenesis, and generation of new collagen fibers via the release of tissue growth factors).
- Said electromagnetic field generates movements of charged molecules (ions) within the inter cellular fluids. This movement generates heat which may enhance the thermal effect discussed earlier.
- the present invention utilizes PEMF (combined with heat applying source) for cosmetic purposes as described above.
- PEMF combined with heat applying source
- the important role of PEMF in the specific field intensities and frequencies increases epidermal collagen synthesis. This new formed collagen increases skin elasticity and rejuvenates its appearance.
- PEMF increases the degree of endothelial cell tubulization and proliferation, and augmented angiogenesis primarily by stimulating endothelial release of FGF-2, inducing paracrine and autocrine changes in the surrounding tissue.
- Angiogenesis the sprouting of new blood vessels, increases blood flow to the tissue, which in turn increases oxygen and nutritional substances delivery to the tissue. This effect is most beneficial for an injured tissue, promoting rapid and improved healing.
- the present invention discloses a system 10 which incorporates both regulated heating means (a heater) and electromagnetic pulses.
- the heat can be produced by: 1. Optical means – by emitting light in different wavelengths absorbed by subcutaneous tissue such that said tissue is heated (e.g., from an illuminator, such as an array of LEDs). 2. Electrical means – by passing electrical current. 3. Electromagnetic means – by transmitting or inducting (electromagnetic induction) electromagnetic filed on the skin. 4. Sound waves – specifically in the ultrasound frequencies. 5.
- the deep tissue diathermy device (4) comprises: a. at least one electrical output device adapted to generate electrical current; and, b. at least two electrodes (41) electrically coupled to said electrical output device and placed on said skin region.
- the deep tissue diathermy device (4) comprises 4 electrodes (denoted by numerical reference 41).
- FIGS.1C-1D illustrate the system 10 in which the deep tissue diathermy device (4) comprises 8 electrodes (denoted by numerical reference 41).
- FIG.1E illustrating an example of electrical current applied by the deep tissue diathermy device (4). The current involves a maximal amplitude of 160 volts, and a frequency close to 1 Hz.
- the pulsed electromagnetic frequency generator is adapted to provide an electromagnetic field which varies with time (dynamic magnetic field).
- the pulsed electromagnetic frequency generator (2) which provides electromagnetic pulses to the patient's skin is positioned near the treated tissue and emits a dynamic magnetic field which varies with time.
- the dynamic magnetic field can vary according to any specific treatments. For examples, to stimulate angiogenesis, pulses at a frequency of 16 Hz, intensity of 12 Gauss and duration of about 5 milliseconds are generated. Alternatively, to stimulate collagen production a triangular wave pulses at a frequency of 25 Hz and intensity of 20 Gauss are generated.
- the deep tissue diathermy device (4) is adapted to apply heat to said region of a patient's skin up to temperature T. According to one embodiment of the present invention the heat is applied by passing electrical current through the tissue.
- the electrical current can be performed in one of the following three manners: 1. Through at least one electrode which is in direct physical contact with the skin; 2.
- FIG.2 illustrates another embodiment of the present invention, According to that embodiment the system additionally comprising a control system (6) adapted to regulate said electromagnetic pulses and/or said electromagnetic pulses.
- the treatment is provided only in safe treatment parameters.
- control system (6) additionally comprises: (a) processing means, adapted to store in a communicable database predetermined parameters defining (i) safe treatment parameters and (ii) unsafe treatment parameters; said parameters are selected from a group consisting of time t of said treatment, temperature T of said tissue, duty cycle t/T, Frequency F, power P, Intensity I of said ultrasound diathermy, energy E applied by the pulses of said pulsed electromagnetic frequency generator, treatment depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), superficial muscle contractions or a combination thereof; (b) sensing means; adapted to sense electromagnetic radiation and heat radiation parameters selected from a group consisting of time t of time t of said treatment, temperature T of said tissue, duty cycle t/T, Frequency F
- the system as defined above additionally comprising sensors for monitoring physical parameters selected form a group consisting of time t of said treatment, temperature T of said tissue, duty cycle t/T, Frequency F, power P, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), treatment depth, superficial muscle contractions or a combination thereof.
- the sensors receives said parameters from the treated tissue and changes the parameters of the pulsed electromagnetic frequency generator (2) and the deep tissue diathermy device (4) to optimize the effect of each component and/or to augment the synergistic effect of both components, whilst avoiding harm to the tissue.
- the shape of the electromagnetic pulse is selected in a non-limiting manner from a group consisting of square wave, a sine wave, a triangular wave, sawtooth wave, ramp waves, spiked wave or any other mathematical combination.
- the system as defined above is adapted to provide electromagnetic pulse at a frequency of 16 Hz which increases from 0 Gauss to 12 Gauss.
- the system as defined above is adapted to provide electromagnetic square wave pulse at a frequency of 16 Hz which increases from 0 Gauss to 12 Gauss.
- the system as defined above is adapted to provide short square waves at a rate of 16 Hz in duration of about 5 milliseconds in an intensity of 12 Gauss. Such square wave pulses are especially provided to stimulate angiogenesis. Reference is now made to FIG.3, which illustrates such square wave pulse.
- the system as defined above is adapted to provide triangular wave pulses at a frequency of 25 Hz and intensity of 20 Gauss. Such pulses are especially provided to stimulate collagen production. Reference is now made to FIG.4, which illustrates such triangular wave pulses.
- the system as defined above is adapted to provide alternating current (AC) at a frequency of 1 MHz.
- AC alternating current
- the system as defined above is adapted to provide intensity of about 80 J/cm 2 sec.
- the magnetic field intensity B of each pulse applied by said pulsed electromagnetic frequency generator (2) ranges between about 0 and about the max magnetic field used in MRI devices (i.e., 3 Tesla).
- the duration of each pulse applied by said pulsed electromagnetic frequency generator (2) ranges between about 3 and about 1000 milliseconds.
- the frequency F applied by the pulses of said pulsed electromagnetic frequency generator (2) ranges between about 1 and about 1M Hz.
- the energy E applied by the pulses of said pulsed electromagnetic frequency generator (2) ranges between about 1 and about 150 watts per pulse.
- the deep tissue diathermy device (4) is selected in a non-limiting manner from a group consisting of electric diathermy or any device emitting RF radiation absorbed by subcutaneous tissue.
- the deep tissue diathermy device (4) is selected in a non-limiting manner from a group consisting of an ultrasonic diathermy, an optical device, electromagnetic induction, sound waves emitting instrument, direct heat applying instrument, or from any other means of heating subcutaneous tissue to temperature T.
- the optical device is adapted to emit light in wavelengths absorbed by subcutaneous tissue such that said subcutaneous tissue is heated.
- the sound waves emitting instrument is adapted to emit sound waves absorbed by the subcutaneous tissue such that said subcutaneous tissue is heated.
- the temperature T is higher than about 30 and lower than about 80 degrees.
- the power supply and control system (6) includes a mechanism for skin cooling.
- system (10) is encased in at least one platform.
- the pulsed electromagnetic frequency generator (2) and said deep tissue diathermy device (4) have more than one applicator to treat more than one body part simultaneously.
- the pulsed electromagnetic frequency generator (2) has electrostatic shielding.
- the system as defined in any of the embodiments produces synergic outcomes in the following three ranges: [0223] The immediate (short) range, in the intermediate range and in the long range. [0224] In the immediate (short) range – the contraction and thickening of collagen fibers occur, which in turn results in an overall tightened and rejuvenated appearance of the skin.
- FIGS.5-6 illustrating another system (20) according to a preferred embodiment of the present invention.
- an integrated system (20) adapted to increase skin rejuvenation of a region of a patient's skin is provided.
- the system 20 comprising at least two electrodes (41) adapted to be placed on said region of a patient's skin; each of said electrodes is a least partially coiled (or looped) via a coil (42).
- each of said electrodes is adapted for both (i) providing electromagnetic pulses to said region of a patient's skin (via said coil); and, (ii) applying heat up to temperature T to said region of a patient's skin.
- all said electrodes provide simultaneously electromagnetic pulses to said region of a patient's skin; and, apply heat up to temperature T to said region of a patient's skin.
- the heat is provided to the skin by applying electrical current through said electrodes which is absorbed by subcutaneous tissue.
- FIG.5 illustrates such a system 20 comprising 4 electrodes (denotes as 41) and FIG. 6 illustrates such a system comprising 8 electrodes (denotes as 41).
- the application of said system 20 increases said skin rejuvenation such that said skin rejuvenation increase (SRI) is greater than the sum of said SRI provided by electromagnetic pulses increase and said SRI provided by said deep tissue diathermy device increase.
- SRI skin rejuvenation increase
- the electromagnetic pulse in system 20 is a triangular shaped at frequency of 25 Hz and intensity of 20 Gauss.
- the electromagnetic pulse in system 20 is square shaped at a frequency of 16 Hz, duration of about 5 milliseconds and intensity of 12 Gauss.
- the system 20 reduces side effects and/or harmful effects of said electromagnetic pulses and/or said deep tissue diathermy such that said reduction of said side effects and/or said harmful effects is greater than the sum of said reduction of said electromagnetic pulses and/or said reduction of said deep tissue diathermy.
- the system 20 additionally comprising a control system (6) adapted to regulate said electromagnetic pulses and/or said electromagnetic pulses.
- the system is adapted to provide a dynamic magnetic field that varies with time.
- the shape of said electromagnetic pulse in system 20 is selected in a non-limiting manner from a group consisting of square wave, a sine wave, a triangular wave, sawtooth wave, ramp waves, spiked wave or any other mathematical combination.
- the magnetic field intensity B in system 20 of each pulse applied by said pulsed electromagnetic frequency generator (2) ranges between about 0 and about 3 Tesla.
- the duration of each pulse applied in system 20 ranges between about 3 and about 1000 milliseconds.
- the frequency F applied by the pulses of said system ranges between about 1 Hz and about 1M Hz.
- the energy E applied by said system ranges between about 1 and about 150 watts per pulse.
- the temperature T is higher than about 30 and lower than about 80 degrees.
- the power supply and control system (6) in system (20) monitors physical tissue parameters and changes applied heat and electromagnetic pulses accordingly.
- the power supply and control system (6) additionally comprising: a.
- processing mean e.g., a processor configured to communicate with a non-transitory computer readable medium configured to store instructions thereon which are executable by the processor to cause the processor to carry out operations
- processing mean e.g., a processor configured to communicate with a non-transitory computer readable medium configured to store instructions thereon which are executable by the processor to cause the processor to carry out operations
- parameters are selected from a group consisting of time t of said treatment, temperature T of said tissue, ratio t/T, Frequency F, power P, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), treatment depth, superficial muscle contractions or a combination thereof; b.
- sensing means e.g., a sensor, a radiation sensor, a thermal sensor, a combination sensor, etc.
- electromagnetic radiation and heat radiation parameters selected from a group consisting of time t of time t of said treatment, temperature T of said tissue, ratio t/T, Frequency F, power P, Intensity I of said ultrasound irradiation, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), treatment depth, superficial muscle contractions or a combination thereof; c.
- the power supply and control system (6) includes a mechanism for skin cooling.
- the system (20) is especially adapted to increase skin rejuvenation in the immediate (short) range.
- the system (20) is especially adapted to increase skin rejuvenation in the intermediate range.
- the system (20) is especially adapted to increase skin rejuvenation in the long range.
- FIG.7 schematically illustrating one possible method (400) of increasing skin rejuvenation of a region of a patient's skin. The method comprising steps selected inter alia from obtaining (i) pulsed electromagnetic frequency generator; and, (ii) a deep tissue diathermy device (401); applying heat to a subcutaneous tissue within said region up to temperature T (402); said temperature T is optimized for production of new dermal ground substance and collagen contraction. While the collagen contraction tightens the skin and conceals wrinkles immediately, the dermal proliferation and new collagen production has a later effect.
- the next step is applying additional pulsed electromagnetic field (403) which generates a healing mechanism of the heated skin, which includes growth factor and cytokines release and eventually angiogenesis.
- additional pulsed electromagnetic field (403) which generates a healing mechanism of the heated skin, which includes growth factor and cytokines release and eventually angiogenesis.
- FIG.8 illustrates another preferred method of the present invention.
- the method 400 additionally comprises the step of: monitoring and/or controlling said steps of applying heat to a subcutaneous tissue within said region and/or said step of applying pulsed electromagnetic therapy to said region (404).
- FIG.9 schematically illustrating one possible method (410) of increasing skin rejuvenation of a region of a patient's skin.
- the method comprising steps selected inter alia from obtaining (i) pulsed electromagnetic frequency generator; and, (ii) a deep tissue diathermy device (411).
- the next step is applying additional pulsed electromagnetic field (412) which generates a healing mechanism of the heated skin, which includes growth factor and cytokines release and eventually angiogenesis.
- the final step is applying heat to a subcutaneous tissue within said region up to temperature T (413); said temperature T is optimized for production of new dermal ground substance and collagen contraction. While the collagen contraction tightens the skin and conceals wrinkles immediately, the dermal proliferation and new collagen production has a later effect.
- FIG.10 illustrates another preferred method of the present invention.
- the method 410 additionally comprises the step of: monitoring and/or controlling said steps of applying heat to a subcutaneous tissue within said region and/or said step of applying pulsed electromagnetic therapy to said region (414).
- FIG.11 schematically illustrating one possible method (420) of increasing skin rejuvenation of a region of a patient's skin. The method comprising steps selected inter alia from obtaining (i) pulsed electromagnetic frequency generator; and, (ii) a deep tissue diathermy device (421). The next step is applying additional pulsed electromagnetic field (422) whilst simultaneously applying heat to a subcutaneous tissue within said region up to temperature T.
- the electromagnetic pulses generate a healing mechanism of the heated skin, which includes growth factor and cytokines release and eventually angiogenesis.
- the heat applied temperature T is optimized for production of new dermal ground substance and collagen contraction. While the collagen contraction tightens the skin and conceals wrinkles immediately, the dermal proliferation and new collagen production has a later effect.
- FIG.12 illustrates another preferred method of the present invention.
- the method 420 additionally comprises the step of: monitoring and/or controlling said steps of applying heat to a subcutaneous tissue within said region and/or said step of applying pulsed electromagnetic therapy to said region (424).
- each of the methods as defined above additionally comprising step of selecting said temperature T from a region of about 30 to about 80 degrees.
- each of the methods as defined above additionally comprising step of applying a dynamic magnetic field onto said region.
- each of the methods as defined above additionally comprising steps of: a.
- parameters defining (i) safe treatment parameters and (ii) unsafe treatment parameters; said parameters are selected from a group consisting of time t of said treatment, temperature T of said tissue, duty cycle t/T, Frequency F, power P, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), treatment depth, superficial muscle contractions or a combination thereof; b.
- sensing electromagnetic radiation and heat radiation parameters selected from a group consisting of time t of time t of said treatment, temperature T of said tissue, duty cycle t/T, Frequency F, power P, Intensity I of said ultrasound diathermy, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), treatment depth, superficial muscle contractions or a combination thereof; c. allowing said electromagnetic radiation and said heat radiation if parameters are within said safe treatment parameters and stopping the electromagnetic radiation if the radiation parameters are in said unsafe treatment parameters.
- the step of applying heat is performed by devices selected from a group consisting of: ultrasonic diathermy, an optical device, electromagnetic induction, sound waves emitting instrument, direct heat applying instrument, or from any other means of heating subcutaneous tissue to temperature T.
- devices selected from a group consisting of: ultrasonic diathermy, an optical device, electromagnetic induction, sound waves emitting instrument, direct heat applying instrument, or from any other means of heating subcutaneous tissue to temperature T.
- each of the methods as defined above additionally comprising step of selecting the magnetic field intensity B of each pulse applied by said step of applying pulsed electromagnetic therapy to said region to be higher than about 0 and lower than about max magnetic field used in MRI devices (i.e., 3 Tesla).
- each of the methods as defined above additionally comprising step of selecting the frequency F applied by the pulses applied by said step of applying pulsed electromagnetic therapy to said region to be higher than about 1 Hz and lower than about 1 MHz.
- each of the methods as defined above additionally comprising step of selecting the energy E applied by said step of applying pulsed electromagnetic therapy to said region to be higher than about 1 and lower than about 150 watts per pulse.
- the step of applying heat lasts about 0.01 to 100 minutes.
- the pulsed electromagnetic field lasts about 0.01 to 100 minutes.
- the steps of applying heat and applying the pulsed electromagnetic therapy are simultaneous, sequential or separate.
- the method is repeated 1 to 100 times in each treatment.
- a typical protocol for the pulsed electromagnetic frequency generator (4) includes for example, and in a non limiting manner, a preset number of 1 microsecond period pulses with duty cycle of 50% and a pause of up to 250 microsecond (in which the preset number of pulses correlates with energy to be supplied to skin under the treatment.)
- a typical protocol for the pulsed electromagnetic frequency generator (4) includes for example, and in a non limiting manner 10 pulses, of 1 microsecond period with 50% duty cycle and preset pause of up to 512 microseconds (in which the pause correlates with energy to be supplied to skin under the treatment).
- a typical protocol for the pulsed electromagnetic frequency generator (4) includes for example, and in a non limiting manner, a repetition of the previous protocol, wherein the number of pulses administered is a multiplication of 10.
- the treatment is repeated more than once.
- each of the methods as defined above additionally comprising step of selecting the shape of said electromagnetic pulse is selected in a non-limiting manner from a group consisting of square wave, a sine wave, a triangular wave, sawtooth wave, ramp waves, spiked wave or any other mathematical combination.
- the first applicator comprises at least one RF electrode.
- the second applicator comprises an optical system to provide laser radiation to treat subcutaneous fat.
- the third applicator provides electrical current to the tissue so as to provide electro muscle stimulation.
- Such device is an advanced medical aesthetic device that offers an effective solution for body aesthetic treatments through non-invasive lipolysis of the any desired body part (e.g., back, thighs abdomen and flanks), resulting in fat reduction.
- the optical system uses, according to one embodiment of the present invention, a 600 ⁇ x 600 ⁇ square profile fiber and an aspheric lens to produce a square image of 60 x 60 mm after about 100mm.
- the source is a multi-mode 600 ⁇ fiber with a numerical aperture of approx.0.22.
- the optical system comprises at least one laser source having a wavelength of about 800 nm - 1200 nm; said optical system is adapted to provide a homogeneous illumination to the skin surface to effect at least one target tissue at a depth of from about 1 mm to about 3 cm from said patient's skin’s surface, at a power density in the range of 0.2 to 3 w/cm2 (most preferably, 1.4 W/cm 2 ). More specifically, the wavelength is in the range of 1060 nm - 1064 nm.
- the homogenous distribution is one with a substantially uniform light distribution under given conditions.
- the 1064 nm diode laser applicators induce lipolysis in the desired body part (e.g., back, thighs abdomen and flanks), leading to destruction of fat cells, giving patients a solution to their stubborn fat deposits.
- the first applicator the RF or combined RF and PEMF
- the second applicator is a diode laser lipolysis treatment.
- the second applicator also includes a cooling mechanism and homogeneously energy distribution to avoid hot spots.
- the optical applicator (the second applicator) can be four diode laser applicators that can be activated individually and placed in various configurations on a belt (or any other wearable element such as a wearable accessory, accoutrement or garment; e.g., a strap, a sleeve and any combination thereof).
- the treatment area of each diode laser applicator measures, e.g., 36 cm 2 .
- the laser applicator energy is capable of effectively penetrating into the hypodermis to affect adipose tissue without harming the skin’s surface. Over time, the body is able to naturally process and eliminate the disrupted fat cells through the lymphatic system.
- Each applicator is equipped with user-friendly features to achieve lipolysis effectively, safely, and comfortably. The energy distribution across the laser applicator, contacting the patient’s skin, is uniform for an even heating of target tissue, preventing hot spots in small areas and increasing the comfort.
- Each individual laser applicator is equipped with four tissue-contact sensors to indicate appropriate contact with the patient’s skin and ensure energy delivery only under these contact conditions, which ensures safety and the desired therapeutic effect.
- the top of each applicator features a red and green LED light to indicate proper and constant coupling of the applicator to the skin during the full course of the treatment.
- a unique belt design is also provided to allow a hands-free operation and ensures continuous contact of the applicators with the skin while assuring patient comfort throughout the treatment.
- FIG.17 illustrating the second applicator (in the FIG.2, optical applicators, 600, are illustrated) and the belt 601 to which said applicators are coupled so as to enable the hands-free operation.
- the coupling therebetween is enabled by simple mechanical connectors 602 (e.g., stretchers, strings etc.).
- Each laser applicator is further enhanced with two internal temperature sensors that measure the water temperature coming in and out from the applicator. This is to ensure that the applicators, and the skin they are in contact with, are constantly cooled during the entire treatment.
- the first applicator has a dual multi-polar electrode crown design, where the outer flat crown constantly controls volumetric heating, while the inner deep tetra- polar crown provides intermittent vacuum-assisted heating.
- vacuum is also provided. This, combined with the multi-polar technology, delivers a significant depth of impact of up to 4.5 cm for a greater effect on cellulite, while also affecting dermal connective tissue, likely via stimulation of fibroblast proliferation and collagen production.
- the first applicator is provided with an adjustable pulsed suction (vacuum) (e.g., a negative pressure means, a negative pressure source, negative pressure applicator, suction means) that facilitates a deep effect on tissue.
- ATC Automatic Temperature Control
- the ATC may be implemented in the form of a programmable temperature regulator which may use pulse-width modulation and hysteresis control to maintain a temperature within a predetermined threshold of a selected temperature.
- the ATC may employ a temperature sensor to determine a deviation between a sensed actual temperature and a preset (selected) temperature, and then activate or selectively turn on/off either heating and/or cooling if the sensed temperature is more than a given deviation from the selected temperature.
- either one of the applicators (the first, second or third) is also equipped with an integrated sensor that provides real-time thermal feedback, allowing for easy, immediate, and continuous monitoring of the skin’s temperature profile.
- the treatment time of the warm-up phase and/or the relax phase is at least 90 sec.
- the applied frequency shifts and increases during that warm-up phase and in the relax phase the applied frequency decreases during the phase.
- the applied frequency, in the warm-up and the relax phases is in the range of 1-100 Hz, most preferably, it is below 10Hz.
- the treatment time of the contraction phase is at least 7 minutes; more preferably, 20 minutes; most preferably, 25 minutes.
- the contraction phase comprises at least one sub- treatment, each sub-treatment comprises 3 cycles, as listed in the following table: [0303]
- the contraction phase comprises at least 3 reoccurring phases of the sub-treatment.
- FIG.18 illustrating an exemplary EMS treatment.
- the EMS treatment comprises 3 phases: ⁇ a warm-up phase; ⁇ a contraction stage phase; and, ⁇ a relax phase.
- the warm-up and the relax phases takes ⁇ 180 seconds and in which the frequencies increases (in the warm-up phase) and decreases (in the relax phase).
- the contraction phase comprises several reoccurring phases of the sub-treatment, each comprises 3 cycles of 3 minutes of 50Hz; 2 minutes of 150 Hz; and, 2 minutes of 5 Hz.
- the shape of the electric waves is selected from the group consisting of a square wave, a sine wave, asymmetrical ladder, Trapezoid, symmetrical ladder, symmetrical bi phasic, a triangular wave, a sawtooth wave, a ramp wave, a spiked wave and any combination thereof.
- the frequency of the electric signal is in the range of about 1Hz-250Hz.
- the duration of the electric signal is in the range of about 400-5,000 microsecond.
- the frequency of the electric signal is in the range of about 40Hz-2,500Hz.
- the shape of the signal is rectangular with waveform symmetric biphasic.
- the used frequency range is from about 1 to about 200 Hz; the pulse width is in the range of about 600 to about 1000 ⁇ S; the max intensity (output Voltage) is about 255 V.
- At least one second applicator in communication with an optical system, said optical system comprising: at least one laser source having a wavelength of about 800 nm - 1200 nm; said optical system is adapted to provide a homogeneous illumination to the skin surface to effect at least one target tissue at a depth of from about 1 mm to about 3 cm from said patient's skin’s surface, at a power density in the range of 0.2 to 3 w/cm 2 .
- the subcutaneous fat may be fat associated with said region of the patient’s skin, e.g., fat beneath the skin.
- said first applicator additionally comprising a control system.
- said control system is adapted to control said electromagnetic field generator and application of RF by said heat by said electrodes (which is converted to heat due to impedance); and, all of said electrodes are adapted to simultaneously provide said electromagnetic pulses to said region of a patient's skin and to apply said heat to said region of a patient's skin.
- cooling means e.g., a cooler, a chilling mechanism, a fan, an air source
- said coil is a helical coil.
- said heat applied to said region of a patient's skin is obtained by emitting RF radiation or via producing electrical current absorbed by subcutaneous tissue.
- each of said electromagnetic pulses has a shape selected from the group consisting of a square wave, a sine wave, a triangular wave, a sawtooth wave, a ramp wave, a spiked wave and any combination thereof.
- said control system (6) monitors physical tissue parameters and changes said applied heat and said electromagnetic pulses accordingly.
- a magnetic field intensity B of each pulse applied by said pulsed electromagnetic frequency generator (2) ranges between about 0 and about 3 Tesla.
- a duration of each pulse applied by said system ranges between about 3 and about 1000 milliseconds.
- a frequency F applied by the pulses of said system ranges between about 1 Hz and about 1M Hz.
- an energy E applied by the pulses of said system ranges between about 1 and about 150 watts per pulse.
- the shape of the electric waves is selected from the group consisting of a square wave, a sine wave, asymmetrical ladder, Trapezoid, symmetrical ladder, symmetrical bi phasic, a triangular wave, a sawtooth wave, a ramp wave, a spiked wave and any combination thereof.
- the frequency of the electric signal is in the range of about 1Hz-250Hz.
- first, second and third applicators are integrated into a single applicator.
- It is another object of the present invention to provide the system as defined above, wherein said first and second applicators are integrated into a single applicator.
- It is another object of the present invention to provide a method of increasing skin rejuvenation of a region of a patient's skin and treating a subcutaneous fat region of said patient, comprising step of: a. obtaining the system of any of the defined above, b. applying either simultaneously or in batch like manner (a) heat to a subcutaneous tissue within said region up to temperature T; (c) radiation in the form of a laser radiation having a wavelength of about 800 nm - 1200 nm; or any combination thereof.
- said laser radiation is provided either in a continuous wave or a pulsed like manner.
- said at least one laser emitting energy in the form of radiation having a wavelength of about 1060 nm - 1064 nm.
- said power density in the range of 0.8 to 1.4 w/cm 2 .
- control system is adapted to control said electromagnetic field generator and application of said heat by said electrodes; and, all of said electrodes are adapted to simultaneously provide said electromagnetic pulses to said region of a patient's skin and to apply said heat (by means of RF energy) to said region of a patient's skin.
- all of said electrodes are adapted to simultaneously provide said electromagnetic pulses to said region of a patient's skin and to apply said heat (by means of RF energy) to said region of a patient's skin.
- method as defined above additionally comprising a step of monitoring and/or controlling said steps of applying heat to a subcutaneous tissue within said region and/or said step of applying pulsed electromagnetic therapy to said region.
- electromagnetic radiation and heat radiation parameters selected from a group consisting of time t of said treatment, temperature T of said tissue, ratio t/T, Frequency F, power P, Intensity I of said ultrasound irradiation, energy E applied by the pulses of said pulsed electromagnetic frequency generator, depth D of said treated tissue, magnetic field intensity B, tissue impedance, specific absorption rate (SAR), treatment depth, superficial muscle contractions or a combination thereof; c. allowing said electromagnetic radiation and said heat radiation if parameters within said safe treatment parameters and to stop the electromagnetic radiation if the radiation parameters are in said unsafe treatment parameters.
- a step of applying a series of electromagnetic pulses said series of electromagnetic pulses comprising recurring applications of a pattern comprising a preset number of square pulses of duration of about 1 microsecond with a duty cycle of 50% followed by a pause of not more than about 250 microseconds.
- step of applying heat is applied for about 0.01 to 60 minutes.
- step of applying heat is performed by devices selected from a group consisting of: ultrasonic diathermy, an optical device, electromagnetic induction, sound waves emitting instrument, direct heat applying instrument, or from any other means of heating subcutaneous tissue to temperature T.
- the shape of the electric waves is selected from the group consisting of a square wave, a sine wave, asymmetrical ladder, Trapezoid, symmetrical ladder, symmetrical bi phasic, a triangular wave, a sawtooth wave, a ramp wave, a spiked wave and any combination thereof.
- the frequency of the electric signal is in the range of about 1Hz-250Hz.
- EXAMPLE 1 A clinical test was performed to demonstrate the synergic effect of the combined PEMF and the deep tissue diathermy device. [0390] The aim of the example is to evaluate the synergetic effect of the combined technology and compare it to each technology individually. [0391] A multi polar magnetic pulsed synthesizer which simultaneously emits RF and magnetic pulses in varying phases that homogeneously cause supra normal temperatures over the treated area and penetrates the dermis and hypodermis was used. METHOD [0392] The test included 40 women at the age of 42-61 years. [0393] They were divided to 4 groups; 1 study group and 3 control groups, each group included 10 clients.
- FIG.13A1-FIG.13C2 are pictures of one patient out of the study group treated with the device of the present invention. The pictures were taken before the treatment (see FIG.13A1 for the forehead and FIG.13A2 for the neck), after the first treatment (see FIG.13B1 for the forehead and FIG.13B2 for the neck) and after the 8 th treatment (see FIG.13C1 for the forehead and FIG.13C2 for the neck).
- First control group [0416] All patients have shown immediate results on both sides, after the first treatment.
- FIGS.14A1-14C2 are pictures of one patient out of the first control group treated with the device of the present invention on the right side and RF on the left side.
- FIGS.15A1-15C2 are pictures of one patient out of the second control group treated with the device of the present invention on the right side and PEMF on the left side. The pictures were taken before the treatment (see FIG.15A1 for the forehead and FIG.15A2 for the neck), after the first treatment (see FIG.15B1 for the forehead and FIG.15B2 for the neck) and after the 8 th treatment (see FIG.15C1 for the forehead and FIG.15C2 for the neck).
- Third control group [0430] All patients have shown on the right side very noticeable immediate and accumulative results (skin tightening and wrinkles fading). [0431] The satisfaction was very high.
- FIGS.16A1 -16C2 are pictures of one patient out of the third control group treated with the device of the present invention on the right side.
- the left side was treated with PEMF followed by RF.
- the pictures were taken before the treatment (see FIG.16A1 for the forehead and FIG.16A2 for the neck), after the first treatment (see FIG.16B1 for the forehead and FIG.16B2 for the neck) and after the 8 th treatment (see FIG.16C1 for the forehead and FIG.16C2 for the neck).
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Abstract
L'invention concerne un système intégré permettant d'accroître le rajeunissement de la peau d'une région de la peau d'un patient et de traiter la graisse sous-cutanée associée à la région. Le système comprend au moins un premier applicateur comportant une ou plusieurs électrodes RF conçues pour être placées sur la région de la peau du patient sans pénétrer dans la peau. Au moins l'une desdites électrodes RF est conçue pour appliquer de l'énergie RF sur la région de la peau du patient pour la chauffer jusqu'à une température dans une plage de température spécifiée. Le système comprend également au moins un second applicateur, en communication avec un système optique. Le système optique comprend au moins une source laser et est conçu pour fournir un éclairage homogène sur la surface de la peau pour avoir un effet au moins sur un tissu cible à une plage de profondeur donnée et à une plage de densité de puissance donnée.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP22837145.6A EP4366639A1 (fr) | 2021-07-08 | 2022-07-08 | Appareil à usage esthétique utile pour accroître le rajeunissement de la peau et méthodes associées |
| CA3225011A CA3225011A1 (fr) | 2021-07-08 | 2022-07-08 | Appareil a usage esthetique utile pour accroitre le rajeunissement de la peau et methodes associees |
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202163219385P | 2021-07-08 | 2021-07-08 | |
| US63/219,385 | 2021-07-08 | ||
| US17/859,933 | 2022-07-07 | ||
| US17/859,933 US20220370814A1 (en) | 2008-06-29 | 2022-07-07 | Esthetic apparatus useful for increasing skin rejuvenation and methods thereof |
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| Publication Number | Publication Date |
|---|---|
| WO2023281448A1 true WO2023281448A1 (fr) | 2023-01-12 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IB2022/056307 WO2023281448A1 (fr) | 2021-07-08 | 2022-07-08 | Appareil à usage esthétique utile pour accroître le rajeunissement de la peau et méthodes associées |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP4366639A1 (fr) |
| CA (1) | CA3225011A1 (fr) |
| WO (1) | WO2023281448A1 (fr) |
Cited By (7)
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|---|---|---|---|---|
| US11794029B2 (en) | 2016-07-01 | 2023-10-24 | Btl Medical Solutions A.S. | Aesthetic method of biological structure treatment by magnetic field |
| US11806528B2 (en) | 2020-05-04 | 2023-11-07 | Btl Healthcare Technologies A.S. | Device and method for unattended treatment of a patient |
| US11826565B2 (en) | 2020-05-04 | 2023-11-28 | Btl Healthcare Technologies A.S. | Device and method for unattended treatment of a patient |
| US11878162B2 (en) | 2016-05-23 | 2024-01-23 | Btl Healthcare Technologies A.S. | Systems and methods for tissue treatment |
| US11883643B2 (en) | 2016-05-03 | 2024-01-30 | Btl Healthcare Technologies A.S. | Systems and methods for treatment of a patient including RF and electrical energy |
| CN117503323A (zh) * | 2023-12-14 | 2024-02-06 | 上海交通大学 | 用于调控皮肤内温度的射频装置 |
| US11896816B2 (en) | 2021-11-03 | 2024-02-13 | Btl Healthcare Technologies A.S. | Device and method for unattended treatment of a patient |
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- 2022-07-08 WO PCT/IB2022/056307 patent/WO2023281448A1/fr active Application Filing
- 2022-07-08 CA CA3225011A patent/CA3225011A1/fr active Pending
- 2022-07-08 EP EP22837145.6A patent/EP4366639A1/fr active Pending
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| US11826565B2 (en) | 2020-05-04 | 2023-11-28 | Btl Healthcare Technologies A.S. | Device and method for unattended treatment of a patient |
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| CN117503323A (zh) * | 2023-12-14 | 2024-02-06 | 上海交通大学 | 用于调控皮肤内温度的射频装置 |
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| Publication number | Publication date |
|---|---|
| CA3225011A1 (fr) | 2023-01-12 |
| EP4366639A1 (fr) | 2024-05-15 |
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