# US 2013/0158634 A1 · Self operated esthetic device with a substrate > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0158634 A1 - Document ID: US20130158634A1 - Status: Published application - Kind: A1 - Application number: 13/820,573 - Filed: 2011-09-05 - Published: 2013-06-20 - Earliest claimed: 2010-09-05 - Assignees: Venus Concept Ltd. - Inventors: Orit Ron Edoute; Oded Ron Edoute - Web page: https://patentgrep.com/patent/US20130158634A1 ## CPC - A61N 5/00: Radiation therapy (ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00) - A61B 18/12: by passing a current through the tissue to be heated, e.g. high-frequency current - A61N 1/328: {for improving the appearance of the skin, e.g. facial toning or wrinkle treatment} - A61N 1/40: Applying electric fields by inductive or capacitive coupling (microwave apparatus A61N5/00); {Applying radio-frequency signals} - A61B 2018/00452: {Skin} - A61B 2018/00648: {using more than one sensed parameter} - A61B 2018/00696: {Controlled or regulated parameters} - A61B 2018/00702: {Power or energy} - A61B 2018/00714: {Temperature} - A61B 2018/00732: {Frequency} - A61B 2018/00779: {Power or energy} - A61B 2018/00791: {Temperature} - A61B 2018/00845: {Frequency} - A61B 2018/00875: {Resistance or impedance} - A61B 2090/065: {for measuring contact or contact pressure} - A61N 5/0625: {Warming the body, e.g. hyperthermia treatment} - A61N 2005/007: {for cooling the patient} - A61N 2005/0628: {including a radiation sensor} - A61N 2005/0645: {Applicators worn by the patient} - A61N 2007/0034: {Skin treatment} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract The present invention provides a self-operated device for treating a skin of a patient, comprising: a. a substrate having a first side and a second side; b. a plurality of RF electrodes arranged in said substrate, said RF electrodes are configured to emit RF radiation from said first side to the surface of said skin; c. at least one RF generator configured to generate pulses of current to said RF electrodes; and, d. a control unit connected to said at least one RF generator, said control unit is adapted to control the operation of said RF electrodes; wherein said control unit is adapted to control the operation of said RF electrodes according to a predetermined treatment protocol, such that the same activates or deactivates at least one of said RF electrodes at any predetermined time interval according to a predetermined pattern so as to achieve a particular therapeutic result. ## Claims ### Claim at position 1 1-145. (canceled) ### Claim 146 A self-operated device for treating a skin of a patient, comprising: a. a substrate having a first side and a second side; b. a plurality of RF electrodes arranged in said substrate, said RF electrodes are configured to emit RF radiation from said first side to the surface of said skin; c. at least one RF generator configured to generate pulses of current to said RF electrodes; and, d. a control unit connected to said at least one RF generator, said control unit is adapted to control the operation of said RF electrodes; wherein said control unit is adapted to control the operation of said RF electrodes according to a predetermined treatment protocol, such that the same activates or deactivates at least one of said RF electrodes at any predetermined time interval according to a predetermined pattern so as to achieve a particular therapeutic result; wherein said predetermined pattern is adapted to mimic a treatment in which an applicator with RF electrodes that are moved on the surface of said skin; further wherein said device is a self-operable device which does not require an operator to be operated. ### Claim 147 (depends on 146) The device according to claim 146, wherein at least one of the following is being held true (a) said substrate is substantially flexible; (b) said substrate is adapted to be incorporated within on object selected from the group consisting of: a bed, a mattress, a chair, any treatment apparatus, a clothing element, a garment and any combination thereof; (c) said treatment protocol is adapted to activate or deactivate at any of said time intervals a substantially different set of RF electrodes; wherein said set of electrodes comprises n RF electrodes, where n equals to or greater than 1. ### Claim 148 (depends on 146) The device according to claim 146, further comprising temperature estimation mechanism for direct or indirect measurement of the skin heat distribution and temperature; wherein said temperature estimation mechanism comprises at least one sensor selected from the group consisting of: an impedance meter for measuring impedance across said RF electrodes; thermal sensor; thermometer; lights sensor, ultrasonic sensor, piezoelectric sensor, magnetic sensor, mechanical sensor, pressure sensor, and any combination thereof. ### Claim 149 (depends on 146) The device according to claim 146, wherein at least one of the following is being held true (a) said device is modular; wherein the modularity of said device is provided by ability to change the size of said substrate by adding and removing elements, such that a predetermined size of said substance is received; (b) said treatment is a safe treatment, such that unexpected thermal injury to said skin is prevented; further wherein the temperate of said skin during said treatment is prevented from increasing beyond 45°; (c) further comprising an input subsystem for manually determining the parameters of said treatment protocol; wherein said input subsystem is controllable by a person selected from the group consisting of: the patient himself, the operator, and any combination thereof; further wherein said input subsystem is adapted to provide fine tuning of the parameters of said treatment protocol; said fine-tuning is adapted to change the temperature generated by said RF electrodes in a range of ±2°. ### Claim 150 (depends on 146) The device according to claim 146, further comprising a plurality of contact sensors in communication with said control unit, said sensors are adapted to detect the areas on said substrate in which said substrate is proximal to said skin; further wherein said control unit is adapted to activate or deactivate only RF electrodes in which said contact sensors detected proximity between said substrate and said skin; further wherein said plurality of contact sensors are selected from the group consisting of: thermal sensors, lights sensors, ultrasonic sensors, piezoelectric sensors, magnetic sensors, mechanical sensors, pressure sensors, and any combination thereof; further wherein said contact sensors are either integrated with said RF electrodes; or, positioned between said RF electrodes. ### Claim 151 (depends on 146) The device according to claim 146, further comprising a feedback mechanism connected to said control unit and adapted to change the parameters of said treatment protocol, according to predetermined parameters; further wherein, said feedback mechanism adapted to change said current to said RF electrodes according to predetermined medical needs, said feedback mechanism comprising: a. sensing means; adapted to sense electrotherapy parameters selected from a group consisting of dermal tensile forces, tissue impedance, muscle contraction forces, skin elasticity, a combination thereof, and any other parameter implying said treatment; b. processing means, adopted to score analyzed tissue parameters according to a predetermined scale of treatment success; said parameters are selected from a group consisting of: dermal tensile forces, tissue impedance, muscle contraction forces, skin elasticity, a combination thereof, and any other parameter implying said treatment; and, c. regulating means, adapted to allow said treatment if said score is higher than a predetermined value and to stop said treatment if said score is lower than a predetermined value. ### Claim 152 (depends on 146) The device according to claim 146, wherein said treatment protocol comprises parameters selected from the group consisting of: power of each of said RF electrodes, length of pulse of each of said RF electrodes, frequency of each of said RF electrodes, the frequency of pulses of each of said RF electrodes, the structure of said pulses of each of said RF electrodes, the shape of said pulses of each of said RF electrodes, and any combination thereof; further wherein at least one of the following is being held true (a) said shape is selected from a group consisting of: triangular, rectangular, ramp, sinusoidal, composite, sawtooth shape, and any combination thereof; (b) said frequency of each of said RF electrodes ranges between about 1 Hz to about 100 MHz; (c) said length of pulse of each of said RF electrodes ranges between about 1 micro seconds to about 1000 milliseconds; (d) said parameters of said treatment protocol are changeable during said treatment according to various circumstances; wherein said various circumstances are selected from: an overheating of said skin, a preprogrammed change as part of said treatment protocol, an unexpected event, or any combination thereof ### Claim 153 (depends on 146) The device according to claim 146, wherein at least one of the following is being held true (a) said RF electrodes are arranged in said substrate according to a geometrical shape selected from the group consisting of: matrix shape, line, at least one circle, zig-zag, polygonal shape, irregular shape, arbitrary shape, and any combination thereof; (b) said substrate is a thin substrate which is characterized by a thickness of between about 20 micrometer to about 25 cm; (c) said substrate is made of a non-conductive but thermally conductive material; (d) said substrate is made of an electrically insulating material; (e) said substrate is made of a material selected from the group consisting of: polyimide, polyester, silicone, plastic, polymeric fabric, polyurethane, textile, cloth, of wool, flax, cotton and any combination thereof; (f) said device further comprising a cooling unit adapted to cool said skin; (g) said device further comprises electronic components arranged in said substrate, said electronic components are selected from the group consisting of: resistors, capacitors, transistors, current regulators, and any combination thereof; (h) said substrate is adapted to conform to a non-planar treatment surface of said skin; (i) said substrate is adapted to be worn on said patient; and any combination thereof. ### Claim 154 (depends on 146) The device according to claim 146, further comprising a pulsed electromagnetic field (PEMF) frequency generator for constantly providing electromagnetic pulses to said skin of said patient; further wherein said device is adapted for simultaneously applying heat by said RF electrodes and PEMF to said skin of said patient; wherein said electromagnetic pulse is square shaped at a frequency of 15 Hz, duration of about 5 milliseconds and intensity of 15 Gauss; further wherein the shape of said electromagnetic pulse is selected from a group consisting of square wave, a sine wave, a triangular wave, sawtooth wave, ramp waves, spiked wave or any other mathematical combination. ### Claim 155 (depends on 146) The device according to claim 146, wherein said plurality of RF electrodes comprises N pairs of RF electrodes, each of said pairs in independent communication with RF generating means, said RF electrodes configured to transmit RF energy to said skin; further wherein said RF generator is adapted to generate N independent RF signals of predetermined waveforms, frequencies, amplitudes, and relative phases; further wherein said device additionally comprising control means for controlling the output of said RF generator, said control means in communication with said RF generator; and, an electrically insulating casing adapted to hold said RF electrodes such that said RF electrodes may be placed in simultaneous physical contact with said skin; wherein said N independent RF signals are phase shifted relative to one another. ### Claim 156 (depends on 155) The device according to claim 155, wherein the time-dependent amplitude At,m of the mth of said N independent RF signals is given by the relationship At,m=A0,m·Fm (ωmt+φm), where A0,m is a predetermined constant which greater than or equals to 1, Fm is a predetermined periodic function of time, ωm is the angular frequency of the mth RF signal, and ωm is a predetermined phase shift of the mth RF signal; wherein for each of said N independent RF signals, ϕ m = π  ( m - 1 )  k N , where 0≦k≦1 and m=1, 2, 3 . . . N; where N is the amount of said RF electrodes pairs; further wherein Fm is chosen from the group consisting of sine, cosine, tan, cotangents (cot), sawtooth wave, triangular wave, square wave, rectangular wave, trapezoidal wave, and any combination of the above. ### Claim 157 (depends on 155) The device according to claim 155, wherein at least one of the following is being held true (a) each of said predetermined frequencies is between about 1 Hz and about 100 MHz; (b) said RF signals are transmitted in either a continues mode or in pulses; wherein, when the RF is applied in pulses, the length of said pulses is between about 0.01 micro-sec and about 1 ms; (c) additionally comprising means adapted to apply Pulsed Electromagnetic Field Therapy (PEMF); wherein the length of said pulses is between about 0.1 and about 1000 ms; (d) the power transmitted by said RF electrodes and said RF generating means to said skin is between 1 W and 700 W; (e) said RF electrodes are further adapted to provide heat to said skin; (f) said device additionally comprising means for massaging said skin; (g) at least one of said RF electrodes comprises a hypodermic syringe for penetrating into subcutaneous tissue; (h) said device further comprising temperature measuring means adapted to measure the temperature of the surface of said skin; said temperature measuring means comprises at least one sensor chosen from the group consisting of impedance meter adapted to measure impedance across at least one of said pairs of RF electrodes; thermal sensor; thermometer; and any combination thereof; wherein said temperature measuring means are either come into contact with the skin or not in contact with the skin; (i) further comprising cooling means adapted to cool said skin; said cooling means are chosen from the group consisting of a Peltier effect cooling device, irrigation with cool water, and means for blowing air across the skin. ### Claim 158 (depends on 155) The device according to claim 155, further comprising a deep tissue diathermy device; said deep tissue diathermy device is chosen from the group consisting of devices emitting RF radiation, any means adapted for producing electrical current absorbed by subcutaneous tissue, acoustic (e.g., ultrasonic) diathermy devices, optical diathermy devices, electromagnetic induction diathermy devices, devices for producing sound waves, ultrasonic diathermy devices, and devices for direct application of heat, optical device adapted to emit light in wavelengths absorbed by subcutaneous tissue such that said subcutaneous tissue is heated, any device for producing sound waves adapted to emit sound waves of a frequency absorbed by the subcutaneous tissue such that said subcutaneous tissue is heated. ### Claim 159 (depends on 155) The device according to claim 155, wherein said control means are adapted to monitor physical tissue parameters and to change at least one of (a) the amount of heat applied and (b) the form of said RF in response to the values of said physical tissue parameters; further wherein said control means additionally comprise a feedback mechanism, adapted to change said RF signal according to predetermined medical needs, and comprising: i. sensing means adapted to monitor electrotherapy parameters related to the level of skin rejuvenation and viability; ii. processing means, adapted to determine the degree of esthetic improvement in at least one tissue parameter related to the level of skin rejuvenation and vitality; and, iii. regulating means adapted to stop the operation of said device when said degree of esthetic improvement reaches a predetermined value. ### Claim 160 (depends on 159) The device according to claim 159, wherein at least one of the following is being held true (a) said electrotherapy parameters are chosen from the group consisting of dermal tensile forces, tissue impedance, muscle contraction forces, skin elasticity, and any combination thereof; (b) said at least one tissue parameter is chosen from the group consisting of dermal tensile forces, tissue impedance, muscle contraction forces, skin elasticity, and any combination thereof; (c) said sensing means are adapted to sense electrotherapy parameters are chosen from the group consisting of time of said treatment, temperature of said tissue, frequency, power, tissue impedance, superficial muscle contractions and any combination thereof; (d) said processing means are adapted to store in a communicable database predetermined parameters defining safe and unsafe treatment conditions; wherein said predetermined parameters are chosen from the group consisting of time of said treatment, temperature of said tissue, frequency, power, tissue impedance, superficial muscle contractions, and any combination thereof ### Claim 161 (depends on 155) The device according to claim 155, additionally comprising at least one acoustic transducer in communication with said substrate, adapted for producing ultrasonic waves; further wherein at least one of the following is being held true (a) said device additionally comprising at least one first coil wrapped around at least a portion of said at least one acoustic transducer; (b) said at least one acoustic transducer is a piezoelectric transducer; (c) said device additionally comprising a plurality of acoustic transducers, wherein a single coil is wrapped around all of said acoustic transducers; (d) said device additionally comprising means for evacuating at least a portion of the skin so as to apply either pulses of suction or a constant vacuum; (e) said device further comprising temperature measurement means and control means adapted to regulate at least one said RF electrical current, said time-varying current, and said alternating current such that the measured skin temperature does not go outside of predetermined limits. ### Claim 162 A method for treating a skin of a patient, comprising steps of: a. providing a self-operated device for treating a skin of a patient, comprising: (i) a substrate having a first side and a second side; (ii) a plurality of RF electrodes arranged in said substrate, said RF electrodes are configured to emit RF radiation from said first side to the surface of said skin; (iii) at least one RF generator configured to generate pulses of current to said RF electrodes; and, (iv) a control unit connected to said at least one RF generator, said control unit is adapted to control the operation of said RF electrodes; b. at least partially contacting or adjacently bringing said substrate with said skin of said patient; c. activating at least one of said RF electrodes at any predetermined time interval according to a predetermined pattern; and, d. controlling said RF electrodes according to a predetermined treatment protocol thereby achieving a particular therapeutic result; wherein said predetermined pattern is adapted to mimic a treatment in which an applicator with RF electrodes that is moved on the surface of said skin; wherein said substrate is substantially flexible. ### Claim 163 (depends on 162) The method according to claim 162, wherein said step (b) of contacting said substrate further comprising step of locating said patient on an object selected from the group consisting of: a bed, a mattress, a chair, any treatment apparatus, a clothing element, a garment and any combination thereof ### Claim 164 (depends on 162) The method according to claim 162, further comprising at least one step of (a) activating at any of said time intervals a substantially different set of RF electrodes according to said treatment protocol wherein said set of RF electrodes comprises n RF electrodes, where n equals to or greater than 1; (b) directly and indirectly measuring the heat distribution and temperature of said skin via a temperature estimation mechanism; wherein said temperature estimation mechanism comprises at least one sensor selected from the group consisting of: an impedance meter for measuring impedance across said RF electrodes; thermal sensor; thermometer; lights sensor, ultrasonic sensor, piezoelectric sensor, magnetic sensor, mechanical sensor, pressure sensor, and any combination thereof ### Claim 165 (depends on 162) The method according to claim 162, further comprising step of detecting the areas on said substrate in which said substrate is proximal to said skin via a plurality of contact sensors in communication with said control unit; wherein said plurality of contact sensors are selected from the group consisting of: thermal sensors, lights sensors, ultrasonic sensors, piezoelectric sensors, magnetic sensors, mechanical sensors, pressure sensors, and any combination thereof ### Claim 166 (depends on 165) The method according to claim 165, wherein said contact sensors are either integrated with said RF electrodes; or, positioned between said RF electrodes. ### Claim 167 (depends on 162) The method according to claim 162, further comprising step of preventing the temperate of said skin to increase beyond 45° during said treatment; wherein said treatment is a safe treatment, such that unexpected thermal injury to said skin is prevented. ### Claim 168 (depends on 162) The method according to claim 162, further comprising steps of providing said device with a feedback mechanism connected to said control unit; and changing the parameters of said treatment protocol, according to predetermined parameters; wherein said feedback mechanism adapted to change said current to said RF electrodes according to predetermined medical needs, said feedback mechanism comprising: (a) sensing means; adapted to sense electrotherapy parameters selected from a group consisting of dermal tensile forces, tissue impedance, muscle contraction forces, skin elasticity, a combination thereof, and any other parameter implying said treatment; (b) processing means, adopted to score analyzed tissue parameters according to a predetermined scale of treatment success; said parameters are selected from a group consisting of: dermal tensile forces, tissue impedance, muscle contraction forces, skin elasticity, a combination thereof, and any other parameter implying said treatment; and, (c) regulating means, adapted to allow said treatment if said score is higher than a predetermined value and to stop said treatment if said score is lower than a predetermined value. ### Claim 169 (depends on 162) The method according to claim 162, wherein said treatment protocol comprises parameters selected from the group consisting of: power of each of said RF electrodes, length of pulse of each of said RF electrodes, frequency of each of said RF electrodes, the frequency of pulses of each of said RF electrodes, the structure of said pulses of each of said RF electrodes, the shape of said pulses of each of said RF electrodes, and any combination thereof ### Claim 170 (depends on 169) The method according to claim 169, wherein at least one of the following is being held true (a) said shape is selected from a group consisting of: triangular, rectangular, ramp, sinusoidal, composite, sawtooth shape, and any combination thereof; (b) said frequency of each of said RF electrodes ranges between about 1 Hz to about 100 MHz; (c) said length of pulse of each of said RF electrodes ranges between about 1 micro seconds to about 1000 milliseconds; (d). ### Claim 171 (depends on 162) The method according to claim 162, further comprising step of manually determining the parameters of said treatment protocol via an input subsystem; wherein said input subsystem is controllable by a person selected from the group consisting of: the patient himself, the operator, and any combination thereof; wherein said input subsystem is adapted to provide fine tuning of the parameters of said treatment protocol; said fine-tuning is adapted to change the temperature generated by said RF electrodes in a range of ±2°. ### Claim 172 (depends on 162) The method according to claim 162, wherein said RF electrodes are arranged in said substrate according to a geometrical shape selected from the group consisting of: matrix shape, line, at least one circle, zig-zag, polygonal shape, irregular shape, arbitrary shape, and any combination thereof ### Claim 173 (depends on 162) The method according to claim 162, further comprising step of providing said device as a modular device; wherein the modularity of said device is provided by ability to change the size of said substrate by adding and removing elements, such that a predetermined size of said substance is received. ### Claim 174 (depends on 162) The method according to claim 162, wherein at least one of the following is being held true (a) said substrate is made of a non-conductive but thermally conductive material; (b) said substrate is made of an electrically insulating material; (c) said substrate is made of a material selected from the group consisting of: polyimide, polyester, silicone, plastic, polymeric fabric, polyurethane, textile, cloth, of wool, flax, cotton and any combination thereof; (d) said device further comprising a cooling unit adapted to cool said skin; (e) said device further comprises electronic components arranged in said substrate, said electronic components are selected from the group consisting of: resistors, capacitors, transistors, current regulators, and any combination thereof; (f) said substrate is adapted to conform to a non-planar treatment surface of said skin; (g) said substrate is adapted to be worn on said patient. ### Claim 175 (depends on 162) The method according to claim 162, further comprising step of providing said device with an adhesive which is adapted to secure said substrate from said first side to a portion of said skin, with said subtract conforming thereto. ### Claim 176 (depends on 162) The method according to claim 162, further comprising step of providing said device with a pulsed electromagnetic field (PEMF) frequency generator for constantly providing electromagnetic pulses to said skin of said patient; wherein said device is adapted for simultaneously applying heat by said RF electrodes and PEMF to said skin of said patient; further wherein said simultaneous application of increases the results of said treatment such that this increase is greater than the sum of the increases when said treatment is performed by said RF electrodes and said PEMF not simultaneously. ### Claim 177 (depends on 176) The method according to claim 176, wherein at least one of the following is being held true (a) said electromagnetic pulse is square shaped at a frequency of 15 Hz, duration of about 5 milliseconds and intensity of 15 Gauss; (b) the shape of said electromagnetic pulse is selected from a group consisting of square wave, a sine wave, a triangular wave, sawtooth wave, ramp waves, spiked wave or any other mathematical combination. ### Claim 178 (depends on 162) The method according to claim 162, wherein said treatment is selected from the group consisting of: skin rejuvenation, smoothing wrinkles, skin tightening circumferential reduction, treatment of cellulite, and any combination thereof.