RU2800894C2 - System and method for treating a user's skin with radio frequency energy - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: group of inventions relates to a system and method for treating a user's skin with radio frequency RF energy. The system contains electrodes, an RF generator, and a controller. The electrodes are configured to transmit RF energy. When executing the method, the skin is treated with electrodes, while using the decision rules with the help of the controller in response to the set parameter values. The parameter indicates the characteristics of the skin. By iterative execution, the appropriate value is set from the set values. The processing setting is determined from the processing settings by applying the decision rules to the set value. Induce RF currents to pass through the skin between the electrodes according to a specific treatment setting. With the help of the controller, the decision rules are changed in response to the set values.

EFFECT: improved efficiency and safety of exposure to RF energy on the skin by determining the skin treatment setting based on the set value of the parameter and changing the decision rules regarding the value of the parameter in response to new medical information.

51 cl, 4 dwg

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority of Provisional Application US 62/683070 titled "Constant RF Energy Density for Skin Tightening - Therapeutic Method and Device", filed June 11, 2018, the disclosure of which is incorporated herein by reference.

FIELD OF TECHNOLOGY TO WHICH THE INVENTION RELATES

The present invention generally relates to the field of cosmetics and in particular to the treatment of skin.

BACKGROUND OF THE INVENTION

US 8,700,176 discloses skin treatment devices and systems for delivering radio frequency (RF) electromagnetic energy to the skin. The devices include one or more RF electromagnetic signal generation units, a plurality of RF electrode arrays, and a controller for controlled delivery of RF energy to the skin through any selected RF electrode array or any selected combination of RF electrode arrays selected from the plurality of RF electrode arrays. The electrodes may be stationary and/or movable. Different radio frequencies and/or frequency bands may be used.

DISCLOSURE OF THE INVENTION

In some embodiments, the present invention provides a system including a plurality of electrodes, one or more radio frequency (RF) generators, and a controller. The controller is configured to process the user's skin using one or more decision rules in response to a plurality of set values of at least one parameter, by iteratively performing: determining at least one corresponding value from the set values, by applying at least one of the decision rules making decisions to a set value, determining a treatment setting among the plurality of treatment settings, and causing the RF generators to cause one or more RF currents to pass through the skin between at least some of the electrodes in accordance with the determined treatment setting. The controller is further configured to change at least one of the decision rules in response to the set values.

In some embodiments, the controller is configured to modify at least one of the AI decision rules.

In some embodiments, another respective one of the RF generators is connected to each of the electrodes.

In some embodiments

the electrodes contain at least three electrodes, with at least one pair of electrodes located further apart than the other pair of electrodes,

while processing settings are assigned to the appropriate groups of electrodes for activation, and

wherein the controller is configured to cause the RF generators to cause RF currents to flow between the set of electrodes assigned to be activated with a certain processing setting.

In some embodiments, at least some of the processing settings are assigned to different respective groups for activation.

In some embodiments

the processing settings are further assigned to respective sets of phases, wherein at least some of the processing settings are assigned to different corresponding sets for the same group, and

wherein the controller is configured to cause the RF generators to induce RF currents to pass between the electrode group by causing the RF generators to supply appropriate RF signals to the electrode group, the RF signals having respectively a set of phases assigned by a certain processing setting.

In some embodiments, the system further includes a path-shaped surface,

at least one of the electrodes is movable along a path,

wherein at least some of the processing settings are assigned different respective electrode spacings, and

wherein the controller is configured to cause the RF generators to cause RF currents to pass between at least some of the electrodes in accordance with the determined processing setting by:

moving the movable electrode along the path such that the movable electrode and the other of the electrodes are spaced apart from each other by an electrode spacing designated by the specific processing setting, and

causing, after moving the movable electrode, the RF generators to induce RF currents to pass between the movable electrode and the other of the electrodes.

In some embodiments

decision rules are represented by mapping a set of parameter domains to processing settings, respectively,

wherein the controller is configured to determine the processing setting by determining the domain to which the set value belongs, and

wherein the controller is configured to change at least one of the decision rules by changing at least one boundary of at least one of the domains.

In some embodiments

the domains are associated with different respective characteristic values, and

wherein the controller is configured to change the boundary of at least one of the domains by:

changing a characteristic value of at least one of the domains based on set values belonging to at least one of the domains, and

adjusting the boundary in response to the changed characteristic value of at least one of the domains.

In some embodiments, the controller is configured to set the boundary equidistant from (i) a changed characteristic value of at least one of the domains and (ii) a characteristic value of another of the domains adjacent to at least one of the domains.

In some embodiments, the controller is configured to change the characteristic value of at least one of the domains by:

calculating an average of the set values belonging to at least one of the domains, and

setting the characteristic value to a weighted average of (i) the characteristic value and (ii) the average value.

In some embodiments

the set values are the first set values, and

wherein the domains include a plurality of skin region domains corresponding to respective skin regions,

each of the skin region domains corresponds to a corresponding one of the skin regions by setting, based on the second set values, a parameter associated with the skin region.

In some embodiments, the skin areas include the cheek and forehead.

In some embodiments, the domains further include one or more electrically improper contact domains corresponding to various respective states in which the electrodes are not in proper electrical contact with the skin and the controller is further configured to:

setting another parameter value,

determining that the other value belongs to one of the domains of improper electrical contact, and

terminating skin treatment in response to determining that another value belongs to the domain of improper electrical contact.

In some embodiments, the states include a state in which the electrodes are not in electrical contact with the skin.

In some embodiments, states include a state in which the electrodes are in electrical contact with the skin, but not through a layer of gel having a thickness in a predetermined range.

In some embodiments, the controller is further configured to generate an output signal indicative of the state to which the misconduct electrical contact domain corresponds.

In some embodiments, the system further comprises a temperature sensor configured to measure skin temperature and, in response, generate a temperature sensor output, the setpoints include temperature temperature values, and the controller is configured to set temperature values in response to the temperature sensor output.

In some embodiments, the system further includes an electric current sensor configured to measure at least some of the RF currents and, in response, generate an output signal, wherein the controller is configured to establish set values in response to the output signal.

In some embodiments, the set values include electrical current property values for a property of at least some of the RF currents.

In some embodiments, the system further includes a voltage sensor configured to measure a voltage associated with at least some of the RF currents and, in response, generate a voltage sensor output, and the controller is configured to set a set value in response to the output. voltage sensor signal.

In some embodiments, the set values include stress property values for the stress property.

In some embodiments, the set values include skin impedance values.

In some embodiments

the controller is further configured to cause, prior to skin treatment, the RF generators to cause the pretreatment electrical current to pass through the skin between any pair of electrodes,

wherein the controller is configured to set an initial one of the set values based on the pretreatment electric current.

In some embodiments, the system further includes a server configured to communicate with the controller over a computer network, and the server and controller are configured to co-execute a process including:

comparing the quantity derived from the set values with the base quantity, and

in response to the comparison, generating an output for the user.

In some embodiments, the output signal includes a message indicating the characteristic of the skin.

In some embodiments, the output signal includes a skin care product recommendation.

In addition, according to some embodiments of the present invention, a method is provided, including: processing, using one or more decision rules, the user's skin in response to a plurality of set values of at least one parameter, by iteratively performing:

establishing at least one corresponding value from the set values,

by applying at least one of the decision rules to the set value, determining a processing setting from a plurality of processing settings, and

causing one or more RF currents to pass through the skin between at least some of the plurality of electrodes in accordance with the determined treatment setting.

The method further includes changing at least one of the decision rules in response to the set values.

The present invention will be better understood by studying the following detailed description of its embodiments and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a schematic illustration of a system for treating a user's skin, in accordance with some embodiments of the present invention;

fig. 2-3 are schematic illustrations of methods for treating a user's skin in accordance with various treatment settings in accordance with some embodiments of the present invention;

fig. 4A is a flow diagram of an iterative method for treating skin according to some embodiments of the present invention; And

fig. 4B is a flow diagram of a post-treatment process in accordance with some embodiments of the present invention.

IMPLEMENTATION OF THE INVENTION

REVIEW

When the dermis layer of the skin is heated to about 50-52°C, the collagen fibers in the dermis are remodeled, thereby causing skin tightening. Therefore, some skin tightening techniques involve heating the skin by applying RF energy to it. RF energy can be applied, for example, using a portable treatment head containing a pair of electrodes. In particular, RF currents can pass between a pair of electrodes when the electrodes are in electrical contact with the skin, so that the RF currents penetrate the skin.

In general, the depth to which each RF current penetrates depends on the distance between the electrodes. For example, the penetration depth for a pair of cylindrical electrodes may be about half the distance between the pair. Therefore, a problem with using the same RF device to tighten multiple skin areas is that the thickness of the skin to be treated, and hence the required penetration depth of the RF currents, can vary from one area to another. For example, while the deepest part of the dermis on the cheek or chin may be 0.2 to 3 mm from the skin surface, the dermis on the forehead may not be deeper than 0.1 to 1 mm. Thus, a penetration depth suitable for the cheek may be dangerous for the forehead, while a penetration depth suitable for the forehead may be ineffective for the cheek.

To solve this problem, the electrode spacing (or "separation") can be varied depending on the thickness of the skin. For example, a first pair of electrodes spaced apart may be used to treat the cheek, while a second pair of electrodes spaced less apart may be used to treat the forehead. Alternatively, the distance between one pair of electrodes can be adjusted depending on the thickness of the skin by moving one or both of the electrodes.

The above approach requires measuring the thickness of the skin during a treatment session, or at least measuring a parameter that is indicative of the thickness. One such parameter is skin impedance; therefore, theoretically, the electrodes can be used to measure skin impedance, and the distance between the electrodes can be changed depending on the measured impedance. However, the impedance of any given area of skin in one user may be different from the impedance of the same area of skin in another user. Moreover, even within a single user, the impedance of any area of the skin can change over time.

To solve this problem, in embodiments of the present invention, the portable processing device comprises a controller configured to deliver RF currents in accordance with specific user decision rules and to continuously update the decision rules over time using artificial intelligence. In particular, during a treatment session, the controller repeatedly sets the value of a parameter, such as the user's skin impedance. Based on each set value, the controller, using a decision rule, assigns an appropriate processing setting, including, for example, an appropriate inter-electrode separation, and then delivers one or more RF currents in accordance with the assigned processing setting. After the processing session, the controller may revise the decision rules based on the set parameter values.

For example, for each user, a plurality of impedance value domains may be mapped to different respective processing settings corresponding to different respective skin regions, with each pair of adjacent domains bordering each other at a respective decision boundary. Thus, for example, for one particular hypothetical user, impedances less than 350 ohms may be associated with a processing setting suitable for the forehead, while impedances greater than 350 ohms may be associated with another processing setting suitable for the cheek. During a processing session, the controller may identify the domain to which each set impedance value belongs, and then select the processing setting to which the domain is associated. After the processing session, the controller may change at least one of the decision boundaries based on the set impedance values.

In some embodiments, to change the decision boundary, the controller first updates the "characteristic impedance" Zc of each of the treated skin areas based on the skin area impedance values that were set during the treatment session. In response to the updated characteristic impedances, the controller may set each decision boundary to be equidistant from the respective characteristic impedances of the two skin regions that meet at the decision boundary.

In some embodiments, to update Zc, the controller first calculates an average Za from the impedance values that were obtained during the treatment of the skin area. The controller then calculates the weighted average of the characteristic current resistance and Za, i.e. the controller sets a new characteristic impedance Zc (n) equal to α * Zc (n-1)+(1-α) * Za (n), where α is, for example, from 0.3 to 0.99, for example, from 0 .85 to 0.95. (In some embodiments, the controller does not update Zc if the skin area has not been treated for at least a predefined minimum duration, such as one minute, and/or if a predefined minimum number of skin area impedance values has not been received.)

Typically, when the user activates the processing device, the controller obtains an initial impedance measurement by applying a short RF current to the skin, referred to herein as a "pre-pulse". Based on this initial measurement, the controller selects a suitable processing setting and starts processing according to this setting. Subsequently, when regular processing pulses are applied, the impedance is measured periodically, for example, with a period of 0.1 to 1 second. Based on each periodic measurement, the controller decides whether to use a different processing setting.

Typically, the controller is further configured to identify situations in which the electrodes are not in proper electrical contact with the skin, such as when the treatment device has been lifted from the skin during a treatment session. In response, the controller may suspend or stop the processing session.

As a rule, the impedance of the skin depends on the amount of moisture in the skin. Therefore, in some embodiments, the controller or cloud server may determine that the user's skin is dry based on the skin impedance values that were set during the treatment session. For example, the controller or server may compare the current characteristic impedance for a particular skin area with the base characteristic impedance for the same user and/or with the base characteristic impedance of a group of other users. If the current characteristic impedance deviates from the baseline, a message may be sent to the user recommending the use of a moisturizer.

SYSTEM DESCRIPTION

First, FIG. 1 which is a schematic illustration of a system 20 for treating the skin of a user 22 according to some embodiments of the present invention. In general, the system 20 can be used to treat any suitable area of the skin, such as the skin of the cheek 24, forehead 26, other part of the face, arm, leg, or abdomen.

The system 20 includes a portable skin tightening device 21 which may be made of plastic and/or any other suitable material. The device 21 includes a shell (or "casing") 44 connected to the head 23 processing. The processing head 23, which is further described below with reference to FIG. 2 comprises a plurality of electrodes 28. The electrodes 28 are typically positioned on the distal surface 46 of the treatment head or within holes in the distal surface 46, such as such that the electrodes protrude from the distal surface 46.

Sheath 44 contains one or more RF generators 30 connected to electrodes 28, typically via wires 29 extending between sheath 44 and processing head 23. Enclosure 44 further includes controller (CONTR) 36, memory 34, and sensor 32. Typically, RF generators 30, controller 36, memory 34, and sensor 32, along with one or more additional components described below, are mounted on electronic board 42. in some embodiments, two or more of these components are integrated into a single chip. For example, device 21 may include a chip containing both controller 36 and memory 34, such as the CY8C4247LQI-BL473 chip manufactured by Cypress SemiconductorTM. In some embodiments, memory 34 includes both internal memory that is integrated with controller 36 as described above and an external memory chip.

Typically, controller 36 is configured to perform at least some of the functions described herein by executing firmware and/or program code. Alternatively, the functionality of the controller 36 may be implemented entirely in hardware.

In order to use the device 21, the user 22 first coats the distal surface 46 (or at least the electrodes 28) with a layer of gel having a thickness within a predetermined range, such as 2-70 mm. The user then runs the treatment head 23 over the user's skin so that the electrodes 28 are in electrical contact with the skin through the gel. As the treatment head passes over the skin, the controller 36 treats the skin of the user 22 with one or more electrical RF currents causing the RF generators to pass currents through the skin between the electrodes in accordance with the feedback from the sensor 32 and the data from the memory 34.

More specifically, during and/or immediately after the application of at least some electrical currents, the sensor 32 measures the corresponding characteristic of the skin or electrical current and in response generates an output signal for the controller 36. For example, the sensor 32 may include a temperature sensor configured to measure the temperature of the skin during and/or immediately after the application of electric current. (Typically, an electric current passing through thinner skin causes a greater temperature rise than an electric current passing through thicker skin.) Alternatively or additionally, sensor 32 may include a current sensor configured to measure an electric current applied to the skin. Alternatively or additionally, sensor 32 may include a voltage sensor configured to measure voltage associated with electrical current, such as voltage across one or more activated electrodes, when current is applied. Alternatively or additionally, sensor 32 may include a moisture sensor configured to measure skin moisture. Alternatively or additionally, sensor 32 may comprise an optical sensor configured to measure optical reflections from the skin and/or an ultrasonic transducer configured to measure ultrasound reflections from the skin.

Based on the output signal of the sensor 32, the controller sets the value of at least one parameter. For example, based on the output of a temperature sensor, the controller may determine the temperature of the skin. Alternatively or additionally, based on the output of the current sensor, the controller may determine a property such as amplitude and/or phase of the applied current. Alternatively or additionally, based on the output of the voltage sensor, the controller may determine a property such as amplitude and/or phase of the voltage between the activated electrodes. Alternatively or additionally, based on the output of the aforementioned current sensor and/or voltage sensor, the controller may determine the skin impedance; for example, the controller may divide the voltage amplitude measured by the voltage sensor by the current amplitude measured by the current sensor.

As a rule, parameter values are set periodically, for example, with a period from several microseconds to one second.

In response to setting each parameter value, the controller assigns a processing setting from a plurality of processing settings by applying at least one decision rule to the set value. For example, the controller may input a parameter value into a machine-learnable model, such as a decision tree or forest, and configured to select a processing setting in response to the input by implementing a set of decision rules. Alternatively, the decision rules may be represented by a mapping from a plurality of parameter domains to processing settings, respectively, so that the controller can assign a processing setting by designating the domain to which the value belongs. In other words, as further described below with reference to FIG. 2-3, the controller may designate the domain to which the set value belongs, and then designate the processing setting to which the domain corresponds according to the mapping.

In response to the assignment of treatment settings, the controller causes the RF generators to induce one or more RF currents to pass through the skin between the electrodes in accordance with the assigned treatment settings. In particular, if, when the processing setting is assigned, the RF current is already supplied in accordance with the assigned processing setting, the controller causes the current to continue to be supplied. (This causality can be active, in that the controller can send an appropriate control signal to the RF generators so that the RF generators continue to supply current, or passive, in the sense that the controller can refrain from stopping the RF generators from supplying current.) otherwise, if the RF current is supplied according to another processing setting, the controller stops the supply of this current by transmitting the appropriate control signal to the RF generators. Subsequently, or if no RF current is applied when the processing setting is assigned, the controller supplies new RF current in accordance with the assigned processing setting by transmitting the appropriate control signal to the RF generators.

Typically, the amplitude of each RF current is 20 to 130 V (eg, 40 to 55 V). In some embodiments, the RF currents are pulsed, such that the duration of each RF current, which may also be referred to as a "pulse" in these embodiments, is between 1 and 1000 ms. (The amplitude and/or duration of each pulse may vary to deliver the required amount of energy to the skin.) Alternatively, a single current may be applied continuously until the next treatment setting is scheduled or until the treatment session is completed.

During or after each processing session, the controller may change at least one decision rule in response to the set parameter values. For example, if decision rules are implemented in a machine learning model, the controller can retrain the model. Alternatively, as further described below with reference to FIG. 2-3, the controller may change the boundary of at least one parameter range stored in memory 34.

Alternatively, or in addition to the components described above, device 21 may include any other suitable components such as a power button or switch, a battery configured to power the device, one or more LEDs, and/or a motion sensor such as an accelerometer. In response to the motion sensor not detecting movement of the device across the skin, the controller can cause the device to turn off, thereby protecting the user's skin from excessive electrical current.

In some embodiments, as shown in FIG. 1, a different corresponding RF generator is connected to each of the electrodes. (Each RF generator also has a ground, which is not shown in the drawing.) In such embodiments, each electrical current is typically generated by applying one RF signal to one electrode and another RF signal of the same amplitude but opposite phase to the other. electrode. The voltage between the pair can then be established by measuring the voltage across one of the electrodes and multiplying that voltage by two. In other embodiments, a single RF generator is connected to all electrodes. As yet another alternative, different sets of multiple electrodes may be connected to different respective RF generators.

In some embodiments, each RF generator operates as a voltage source because the RF generator is configured to supply a predetermined voltage. However, since the amplitude of the actually applied voltage may differ from the predetermined amplitude, for example due to the discharge of the battery powering the device, the applied voltage can be measured. Similarly, the applied current can be measured even if the RF generator is operating as a current source.

In some embodiments, device 21 further comprises a communication interface, such as a network interface (not shown), a WiFi interface, and/or a Bluetooth interface. Through the communication interface, the controller may communicate with an external processor, such as a processor owned by the user's smartphone and/or a processor 39 owned by the cloud server 38. (Optionally, the controller may communicate with the processor 39 via the user's smartphone.) At least some of these communications may be transmitted over a suitable computer network 40 such as the Internet.

Typically, the server 38 further comprises a network interface 37, such as a network interface controller (NIC). Through the network interface 37, the processor 39 can communicate with the device 21, the user's smartphone and/or any number of other devices owned by other users.

In general, each of the processors described herein may be implemented as a single processor or as a networked or clustered set of processors. In some embodiments, the functionality of at least one of the processors as described herein is implemented entirely in hardware, such as using one or more application specific integrated circuits (ASICs) or field programmable gate arrays (FPGAs). In other embodiments, the functionality of each processor is at least partially implemented in software. For example, in some embodiments, each processor is implemented as a programmed digital computing device including at least a central processing unit (CPU) and random access memory (RAM). Program code, including software, and/or data is loaded into RAM for execution and processing by the CPU. The program code and/or data may be downloaded to the processor in electronic form, such as over a network. Alternatively or additionally, the program code and/or data may be provided and/or stored on non-volatile tangible media such as magnetic, optical or electronic memory. Such program code and/or data, when provided to a processor, creates a machine or special computer configured to perform the tasks described herein.

ADAPTIVE SKIN TREATMENT

Next, FIG. 2 which is a schematic illustration of a method for treating a user's skin in accordance with various treatment parameters in accordance with some embodiments of the present invention.

In some embodiments, the skin tightening device comprises at least three electrodes, with at least one pair of electrodes spaced further apart than the other pair of electrodes. In the specific exemplary embodiment of FIG. 2, for example, four electrodes protrude from the distal surface 46: a first electrode 28a, a second electrode 28b, a third electrode 28c, and a fourth electrode 28d. Some pairs of these electrodes have a first electrode spacing d1, others have a second electrode spacing d2 that is greater than d1, and a third electrode spacing d3 that is greater than d2. (The distance between the first electrode 28a and the fourth electrode 28d is not explicitly indicated in the drawing.) As another purely illustrative example, the first electrode 28a may be at a distance d3 from each of the second electrode 28b and the third electrode 28c, the second electrode 28b may be at a distance d1 from the third electrode 28c, and the fourth electrode 28d may be at a distance d2 from each of the second electrode 28b and the third electrode 28c. (Example values for these distances are 2 mm for d1, 3 mm for d2, and 4 mm for d3.) Alternatively, the electrodes may be of any other suitable number and/or may be arranged in any other suitable configuration.

In such embodiments, the processing settings stored in the memory 34 assign the appropriate groups of electrodes to be activated. For example, a memory may store a mapping of a plurality of domains of a corresponding parameter, such as impedance or skin temperature, to corresponding groups of electrodes for activation. In response to determining a processing setting for each set parameter value, the controller causes the RF generators to induce one or more electrical currents to flow between the group of electrodes designated by the particular processing setting for activation.

Typically, at least some of the processing settings specify different appropriate groups to activate. For example, the hypothetical display of FIG. 2 includes four different groups of activated electrodes: (i) domain [x0, x1) is mapped to a group consisting of a first electrode 28a, a second electrode 28b, and a third electrode 28c, (ii) a domain [x1, x2) is mapped to a group consisting of of the first electrode 28a, the third electrode 28c, and the fourth electrode 28d, (iii) the domain [x2, x3) is mapped into a group consisting of the second electrode 28b and the fourth electrode 28d, and (iv) each of the domains [x3, x4) and [x4 , x5) are displayed in a group consisting of all electrodes.

In some embodiments, the processing parameters further define respective sets of phases, at least some of the processing parameters define different respective sets of phases for the same group of electrodes. In response to determining the processing setting, the controller causes the RF generators to apply appropriate RF signals to the group of electrodes designated by the processing setting, the RF signals having, respectively, a set of phases assigned by the particular processing setting.

For example, in FIG. 2, although the [x3, x4) and [x4, x5) domains are mapped to the same electrode group, these domains are mapped to different respective phase sets. Specifically, for the [x3, x4) domain, the first electrode 28a and the third electrode 28c have a zero phase, and the second electrode 28b and the fourth electrode 28d have a 180 degree phase. (Thus, according to this processing setting, RF signals are applied to the electrodes so that the polarity of the first electrode 28a and the third electrode 28c is opposite to the polarity of the second electrode 28b and the fourth electrode 28d.) For the [x4, x5] domain, on the other hand , the first electrode 28a and the fourth electrode 28d have a zero phase, while the second electrode 28b and the third electrode 28c have a 180 degree phase.

Typically, the domains include a plurality of skin region domains corresponding to respective skin regions, with each of the skin region domains corresponding to a respective one of the skin regions by setting based on the values of a parameter associated with the skin region. For example, one domain may correspond to a cheek by being defined based on cheek related parameter values, such as cheek impedance values. The other domain may correspond to the forehead by setting based on forehead related parameter values such as forehead impedance values.

In some embodiments, parameter values used to determine skin area domains are collected during a calibration procedure. During this procedure, the user sweeps the treatment head over areas of skin for which skin area domains must be defined. For each of these areas, RF currents are applied to it, and the parameter values \u200b\u200bare set.

For example, prior to using the treatment device, the user may move the treatment head (with a suitable thick layer of gel covering the electrodes) sequentially over a plurality of specific skin areas, indicating to the controller (for example, by pressing a specific button) each transition from one skin area to another. For each skin area, the controller may set a plurality of parameter values, and then set a domain for the skin area based on the set values. For example, for each area of the skin, the controller may calculate the corresponding characteristic value (Char.value), for example, by calculating the average value of the set values (excluding any outliers). The controller may then set the boundaries of the domains such that each boundary between adjacent domains is equidistant from the corresponding characteristic values of the adjacent domains.

For example, based on the calibration procedure, the controller may calculate a characteristic impedance ZC for the user's cheek and a characteristic impedance ZF for the forehead of the user. In response, the controller may set a boundary (ZC+ZF)/2 between the cheek area and the forehead area.

In other embodiments, the values are collected from a suitable population of other users. Based on the values, the processor (eg, processor 39 (FIG. 1)) defines a set of default skin region domains that can be loaded into the memory of each skin tightening device during manufacture.

In any case, whether the domains are calculated based on a user-specific calibration procedure or based on data obtained from the general population, the domain boundaries can be adjusted throughout the life of the device, as further described below.

In some embodiments, the domains in memory 34 further include one or more electrically improper contact domains corresponding to various appropriate states in which the electrodes are not in proper electrical contact with the skin. In response to the establishment during processing of the value of the parameter belonging to the area of improper electrical contact, the controller stops processing the skin or suspends processing until the proper electrical contact is restored.

Typically, at least one of the electrically inappropriate contact domains corresponds to a state in which the electrodes are not in any electrical contact with the skin. For example, the "gel domain", which may include, for example, impedances from 550 to 800 ohms, may correspond to a state in which the electrodes are coated with a gel layer having a thickness within a predetermined range, but not in electrical contact with the skin. As another example, "air region", which may include, for example, impedances above 4000 ohms, may correspond to a state in which the electrodes are not coated with gel and are not in electrical contact with the skin. As another example, a "short region", which may include, for example, impedances of less than 100 ohms, may correspond to a state in which the electrodes are electrically connected to each other through a low resistance conductor, such as a user's wrist watch.

Alternatively or additionally, one of the improper electrical contact domains may correspond to a state in which the electrodes are in electrical contact with the skin, but not through a gel layer having a thickness in a predetermined range; in other words, the electrodes may be coated with too little or too much gel. As a purely illustrative example, the area corresponding to skin contact with too little intermediate gel may include impedances from 1800 to 4000 ohms, while the area corresponding to skin contact with too much intermediate gel may include impedances from 100 to 200 ohms. .

In some embodiments, in response to detecting a condition in which the electrodes are not in proper electrical contact with the skin, the controller generates an output signal indicative of the condition. For example, in response to detecting an inappropriate amount of gel, the controller may cause the appropriate LED to turn on so that the user is aware of the need to increase or decrease the amount of gel. Alternatively or additionally, the controller may send a message indicating the status to an external device such as the server 38 (FIG. 1) or the user's smartphone. In response to receiving this message, the external device may generate an output to the user indicating the status, along with any action necessary to resume processing. For example, in the event of an inappropriate amount of gel, the user may be instructed to increase or decrease the amount of gel.

Each of the improper electrical contact domains can be defined by passing RF currents between the electrodes and setting the corresponding parameter values while the electrodes are in the corresponding electrical improper contact state. Alternatively, at least one of the domains of improper electrical contact may be defined based on pre-existing data, such as tables of impedance values for various types of materials. In any case, typically the same set of inappropriate electrical contact domains is loaded into the memory of each skin tightening device at the time of manufacture.

During each processing session, the controller may store in memory 34 each set value belonging to each domain. Subsequently, after the processing session, based on the stored values, the controller can change the corresponding characteristic values of one or more domains. The controller may then reset at least one of the domain boundaries in response to the changed characteristic values. For example, the controller may set each boundary to be equidistant from the two nearest characteristic values.

In some embodiments, the implementation of the controller changes the characteristic value of the domain by calculating the average value of the set values belonging to the domain, and then setting the characteristic value to the weighted average (current) characteristic value and the average value. In other words, given the characteristic value Har.val.i and the average value M of the set values, the controller can calculate the new characteristic value Har.val+1 as α Har.val+(1-α) M, where α is a suitable constant from zero to units, such as a constant from 0.3 to 0.99, such as from 0.85 to 0.95.

As an alternative to assigning one characteristic value to each domain, the controller may assign several characteristic values to each domain, for example by calculating several local averages from a plurality of parameter values belonging to the domain. In such embodiments, in response to a plurality of parameter values set during a processing session, the controller may update one or more local averages. Subsequently, the controller may change the boundary between two adjacent domains by minimizing the sum of squared distances between the boundary and local averages in the adjacent domains, or by using any other suitable technique.

Next, FIG. 2 which is a schematic illustration of a method for treating a user's skin in accordance with various treatment parameters in accordance with some embodiments of the present invention.

In some embodiments, surface 46 is shaped to define path 48 and at least one electrode 28e is movable along path 48 so that electrode distance "c" between electrode 28e and another electrode 28f can be adjusted. For example, the movable electrode may be positioned within the track, with the proximal end of the movable electrode, which is below surface 46, screwed onto a screw parallel to the track and connected to the motor. By using the motor to turn the screw, the controller can move the movable electrode towards or away from the electrode 28f.

In such embodiments, at least some of the processing settings stored in memory 34 assign various appropriate inter-electrode separations. For example, in FIG. 3 for the same set of hypothetical domains from FIG. 2 shows the various corresponding inter-electrode separations c1, c2, c3, c4 and c5. During a treatment session, in response to determining a suitable treatment setting, the controller moves the electrode 28e along the path so that the electrode 28e and the electrode 28f are separated from each other by an electrode spacing designated by the treatment setting. After electrode 28e is moved, the controller causes the RF generators to induce one or more electrical currents to pass between electrode 28e and electrode 28f. (Note that the processing setting can implicitly indicate inter-electrode separation by assigning the position of the moving electrode relative to any coordinate system.)

In general, for such embodiments, the controller may change the characteristic values and/or boundaries for domains, as described above with reference to FIG. 2.

In some embodiments, the processing head 23 comprises one or more pairs of electrodes in a fixed position, as in FIG. 2 together with at least one moving electrode as in FIG. 3. Thus, the processing setting can assign a group of activated electrodes (optionally together with the corresponding phases for the group) together with an inter-electrode separation for the moving electrode.

It should be noted that the processing settings may assign additional processing parameters not described above with reference to FIG. 2-3. For example, the two processing settings may be assigned different corresponding voltage or current amplitudes.

In some cases, a combination of domains can be mapped to a single processing setting. Thus, for example, a particular impedance value domain in combination with a first temperature or humidity value domain can be associated with a first treatment setting, while the same impedance value domain in combination with a second temperature or humidity value domain can be associated with a second treatment setting. processing.

Preferably, the combination of an impedance domain with a temperature or humidity domain may take into account the fact that skin impedance may be dependent on skin temperature or moisture such that one impedance domain may correspond to different respective skin areas at different respective temperatures or humidity levels. In addition, this scheme may facilitate the provision of multiple treatment settings for one area of the skin. For example, at the start of a treatment session, when the skin temperature is relatively low, a first treatment setting that assigns a relatively large number of activated electrodes can be used. However, as the session continues and the skin temperature approaches the predetermined safety threshold, a second treatment mode can be used that assigns fewer activated electrodes.

EXAMPLES OF ALGORITHMS

Further reference is made to FIG. 4A, which is a flowchart of an iterative skin treatment method 50 according to some embodiments of the present invention. The method 50 is executed by the controller 36 (FIG. 1) after turning on the device 21 (FIG. 1) and, optionally, an input from the user (eg, by pressing an appropriate button) indicating that the user wishes to start a processing session.

Typically, method 50 begins with a pre-pulse step 52 in which the controller causes the RF generators to cause the pre-treatment electrical current to pass through the skin between any pair of electrodes prior to treating the skin. (The duration of this "pre-pulse" is typically 1 to 20 ms, such as 1 to 5 ms.) In some embodiments, one pair of electrodes on the treatment head is dedicated to delivering the pre-pulse; in other embodiments, the steam used for the prepulse may vary from one feed to the next.

Based on the prepulse, the controller sets the initial value of the corresponding parameter, such as the skin temperature, the amplitude and/or phase of the prepulse, or the amplitude and/or phase of the interelectrode voltage, at the step of setting the value of the parameter 54. Then, at the step 56 of determining the domain, the controller determines the domain to which the parameter value.

Next, in step 58 of domain classification, the controller checks whether the determined domain is a skin area domain. If so, the controller determines the processing setting in the setting determination step 60 with which, according to the mapping in the memory 34 (FIG. 1), the specific domain is mapped. In response to determining the treatment settings, the controller causes the RF generators to induce one or more electrical currents to pass through the skin between the electrodes in accordance with the assigned treatment settings.

On the other hand, if the determined domain is not a skin area domain (but rather an improper electrical contact domain), the controller decides in decision step 59 whether to stop skin treatment. For example, the controller can determine if a certain domain corresponds to a state in which the device or user is at risk of harm, such as in the event of a short circuit or insufficient gel coverage of the electrodes. If the controller decides to stop processing, it proceeds to step 65 post-processing, described below. Otherwise, the controller returns to step 52 pre-pulse. In this way, the controller can deliver repeated pre-pulses until proper electrical contact is established between the electrodes and the skin.

After the energizing step 62, the controller checks in a duration check step 64 whether the duration of the processing session exceeds a predetermined safety limit, such as two or three minutes. If not, the controller returns to step 54 setting the parameter value. Otherwise, the controller stops processing the skin and proceeds to step 65 post-processing. In the same way as described above with reference to FIG. 1, processing may be stopped in response to no detectable device movement. Similarly, the treatment may be stopped in response to skin temperature exceeding the aforementioned predetermined safety threshold, or in response to the user actively terminating the treatment, for example by pressing an appropriate button.

After processing the skin, the controller performs a post-processing step 65 in which the controller, typically using artificial intelligence, changes at least one boundary of at least one of the parameter value domains in response to the parameter values set during processing. In this regard, reference is made here to FIG. 4B, which is a block diagram for a post-processing step 65 according to some embodiments of the present invention.

The post-processing step 65 begins with a first check step 66 in which the controller checks if any of the skin area domains determined during method 50 have not yet been processed. domain. Then, in the second test step 70, the controller checks if the number of parameter values set for the selected domain exceeds a predetermined threshold. If so, the controller, in step 72 calculate the average value, calculates the average value of the parameters set for the selected domain (excluding any outliers). Then, in step 74 change the characteristic value, the controller changes the characteristic value for the selected domain based on the average value. For example, as described above with reference to FIG. 2, the controller may calculate a weighted average of the characteristic value and the average value. After step 74 of changing the characteristic value, or if not enough parameter values have been set, the controller returns to step 66 of the first check.

In response to first checking at step 66 that there are no unprocessed defined skin area domains, the controller changes the boundaries of the skin area domains at step 76 based on the changed characteristic values. For example, as described above with reference to FIG. 2, the controller may set each boundary of each domain of the skin area to be halfway between the characteristic value of the domain and the characteristic value of the corresponding adjacent domain.

OTHER EMBODIMENTS FOR CARRYING OUT THE INVENTION

In some embodiments, server 38 (FIG. 1) and controller 36 are configured to jointly perform a process including comparing a quantity derived from at least some set parameter values with a base quantity, and in response to the comparison, generating an output signal for user, for example, by sending an email message to the user's email account or a text message to the user's phone.

For example, the controller may send to the server a plurality of set temperature or impedance values for at least one area of the user's skin. The server can then calculate the mean or median of these values and compare this number to the baseline. (Alternatively, the controller may calculate an average or median value and communicate this value to the server.) In response to the comparison, the server may determine a skin characteristic, such as skin moisture. In response, the server may generate an output message for the user, such as a message indicating a characteristic (eg, a message indicating that the skin is dry) and/or a recommendation for a skin care product (eg, moisturizer). Skin care product recommendations may also be provided to the user regardless of the user's skin properties based on data collected from other users.

Alternatively or additionally, the controller and at least one external processor, such as the processor 39 (FIG. 1) belonging to the server 38 and/or the processor belonging to the user's smartphone, may jointly perform at least some of the functions described above with reference to blueprints. For example, during each processing session, the controller may transmit each set parameter value to an external processor, and the external processor may then determine the appropriate processing setting and transmit the processing setting to the controller. Alternatively or additionally, the post-processing in which the decision rules are changed may be performed by an external processor.

Those skilled in the art will appreciate that the present invention is not limited to what has been specifically shown and described above. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications thereof, which may be apparent to those skilled in the art upon reading the above description, and which are not disclosed in the prior art.

Claims (109)

1. A system for treating a user's skin with radio frequency (RF) energy, comprising: electrodes configured to transmit RF energy; one or more RF generators; And controller configured for: processing, using one or more decision rules, the skin in response to the set values of at least one parameter indicative of the characteristic of the skin, by iteratively performing: establishing at least one corresponding value from the set values, by applying at least one of the decision rules to the set value, determining a processing setting among the processing settings, and causing the RF generators to cause one or more RF currents to pass through the skin between at least some of the electrodes in accordance with the determined treatment setting, and changing at least one of the decision rules in response to the set values. 2. The system of claim 1, wherein the controller is configured to modify at least one of the AI decision rules. 3. The system according to any one of claims 1, 2, wherein the other one of the RF generators is connected to each of the electrodes. 4. The system according to any one of claims 1 to 3, wherein the electrodes comprise at least three electrodes, with at least two electrodes spaced further apart than the other two electrodes, while processing settings are assigned to the appropriate groups of electrodes for activation, and wherein the controller is configured to cause the RF generators to cause RF currents to flow between the set of electrodes assigned to be activated with a certain processing setting. 5. The system of claim 4, wherein at least some of the processing settings are assigned, for activation, to various respective groups. 6. A system according to any one of claims 4, 5, wherein the processing settings are further assigned to respective sets of phases, wherein at least some of the processing settings are assigned to different respective sets for the same group, and wherein the controller is configured to cause the RF generators to induce RF currents to pass between the electrode group by causing the RF generators to supply appropriate RF signals to the electrode group, the RF signals having respectively a set of phases assigned by a certain processing setting. 7. The system according to any one of claims 1 to 3, further comprising a surface shaped to set the path, wherein at least one of the electrodes is configured to move along the path, wherein at least some of the processing settings are assigned different respective electrode spacings, and wherein the controller is configured to cause the RF generators to cause RF currents to pass between at least some of the electrodes in accordance with the determined processing setting by: moving the movable electrode along the path such that the movable electrode and the other of the electrodes are spaced apart from each other by an electrode spacing designated by the specific processing setting, and causing, upon movement of the movable electrode, the RF generators to be induced to pass RF currents between the movable electrode and the other of the electrodes. 8. The system according to any one of claims 1 to 7, wherein the decision rules are represented by mapping parameter domains to processing settings, respectively, wherein the set values are the first set values, moreover, the domains include domains of the skin area corresponding to the corresponding areas of the skin, each of the domains of the skin area corresponds to the corresponding one of the skin areas by setting, based on the second set values of the parameter associated with the skin area, wherein the controller is configured to determine the processing setting by determining the domain to which the set value belongs, and wherein the controller is configured to change at least one of the decision rules by changing at least one boundary of at least one of the domains. 9. The system of claim 8, wherein the domains are associated with different respective characteristic values, and wherein the controller is configured to change the boundary of at least one of the domains by: changing the characteristic value of at least one of the domains based on the first set values belonging to at least one of the domains, and adjusting the boundary in response to the changed characteristic value of at least one of the domains. 10. The system of claim 9, wherein the controller is configured to set the boundary equidistant from (i) a changed characteristic value of at least one of the domains and (ii) a characteristic value of another of the domains adjacent to at least one of the domains. 11. The system according to any one of claims 9, 10, wherein the controller is configured to change the characteristic value of at least one of the domains by: calculating the average of the first set values belonging to at least one of the domains, and setting the characteristic value to a weighted average of (i) the characteristic value and (ii) the average value. 12. The system according to any one of claims 8 to 11, wherein the skin areas include the cheek and forehead. 13. The system according to any one of claims 8-12, wherein the domains further include one or more electrically improper contact domains corresponding to various respective states in which the electrodes are not in proper electrical contact with the skin, wherein the controller is further configured to : setting another parameter value, determining that the other value belongs to one of the domains of improper electrical contact, and terminating skin treatment in response to determining that another value belongs to the domain of improper electrical contact. 14. The system of claim 13, wherein the states include a state in which the electrodes are not in electrical contact with the skin. 15. The system according to any one of claims 13, 14, wherein the states include a state in which the electrodes are in electrical contact with the skin, but not through a gel layer having a thickness in a predetermined range. 16. The system according to any one of claims 13-15, wherein the controller is further configured to generate an output signal indicative of the state to which the improper electrical contact domain corresponds. 17. The system according to any one of claims 1 to 16, further comprising a temperature sensor configured to measure the temperature of the skin and, in response, generate a temperature sensor output signal, while the set values include temperature temperature values, while the controller is configured to set temperature values in response to the temperature sensor output. 18. The system according to any one of claims 1-17, further comprising an electric current sensor configured to measure at least some of the RF currents and, in response, generate an output signal, while the controller is configured to establish set values in response to the output signal. 19. The system of claim 18, wherein the set values include electrical current property values such as amplitude or phase for at least some of the RF currents. 20. The system according to any one of claims 1-19, further comprising a voltage sensor configured to measure the voltage associated with at least some of the RF currents and, in response, generate a voltage sensor output signal, the controller is configured to set set values in response to the voltage sensor output. 21. The system of claim 20, wherein the set values include voltage property values such as voltage magnitude or phase. 22. A system according to any one of claims 1-21, wherein the set values include skin impedance values. 23. The system according to any one of claims 1-22, wherein the controller is further configured to cause, prior to skin treatment, the RF generators to cause the pretreatment electrical current to pass through the skin between any pair of electrodes, wherein the controller is configured to set an initial one of the set values based on the pretreatment electric current. 24. The system according to any one of claims 1 to 23, further comprising a server configured to communicate with the controller over a computer network, while the server and the controller are configured to jointly perform a process, including: comparing the quantity derived from the set values with the base quantity, and in response to the comparison, generating an output for the user. 25. The system of claim 24, wherein the output signal includes a message indicative of a skin characteristic. 26. The system according to any one of claims 24, 25, wherein the output signal includes a recommendation for a skin care product. 27. A method of treating the user's skin with radio frequency (RF) energy, including: skin processing using one or more decision rules and electrodes configured to transmit RF energy by a controller, in response to set values of at least one parameter indicative of a skin characteristic, by iteratively executing: establishing at least one corresponding value from the set values, by applying at least one of the decision rules to the set value, determining the processing setting from the processing settings, and causing one or more RF currents to pass through the skin between at least some of the electrodes in accordance with a particular treatment setting; And changing, via the controller, at least one of the decision rules in response to the set values. 28. The method of claim 27, wherein changing at least one of the decision rules includes changing at least one of the decision rules using artificial intelligence. 29. The method according to any one of claims 27, 28, in which the electrodes contain at least three electrodes, and at least two electrodes are located further apart than the other two electrodes, while processing settings are assigned to the appropriate groups of electrodes for activation, and wherein causing the RF currents to pass between at least some of the electrodes includes causing the RF currents to pass between a group of electrodes assigned to activate a certain processing setting. 30. The method of claim 29, wherein at least some of the processing settings are assigned, for activation, to various respective groups. 31. The method according to any one of claims 29, 30, wherein the processing settings are further assigned to respective sets of phases, wherein at least some of the processing settings are assigned to different respective sets for the same group, and wherein causing the RF currents to pass between the electrode group includes causing the RF currents to pass between the electrode group by causing one or more RF generators to supply appropriate RF signals to the electrode group, the RF signals having, respectively, a set of phases assigned certain processing setting. 32. The method according to any one of claims 27-28, wherein at least one of the electrodes is movable along a path, wherein at least some of the processing settings are assigned different respective electrode spacings, and wherein causing the RF currents to pass between at least some of the electrodes in accordance with a particular processing setting includes: moving the movable electrode along the path so that the movable electrode and the other of the electrodes are spaced apart by an electrode distance from each other designated by the specific processing setting, and causing, after moving the movable electrode, RF currents to pass between the movable electrode and the other of the electrodes. 33. The method according to any one of claims 27-32, wherein the decision rules are represented by a mapping from parameter domains to processing settings, respectively, wherein the set values are the first set values, moreover, the domains include domains of the skin area corresponding to the corresponding areas of the skin, each of the domains of the skin area corresponds to the corresponding one of the skin areas by setting, based on the second set values of the parameter associated with the skin area, wherein determining the processing setting includes determining the processing setting by determining the domain to which the set value belongs, and wherein changing at least one of the decision rules includes changing at least one of the decision rules by changing at least one boundary of at least one of the domains. 34. The method of claim 33, wherein the domains are associated with different respective characteristic values, and while changing the boundary of at least one of the domains includes: changing the characteristic value of at least one of the domains based on the first set values belonging to at least one of the domains, and adjusting the boundary in response to the changed characteristic value of at least one of the domains. 35. The method of claim 34, wherein setting the boundary includes setting the boundary equidistant from (i) the changed characteristic value of at least one of the domains and (ii) the characteristic value of another one of the domains adjacent to at least one of the domains. 36. The method according to any one of claims 34, 35, in which the change in the characteristic value includes: calculating the average of the first set values belonging to at least one of the domains, and setting the characteristic value to a weighted average of (i) the characteristic value and (ii) the average value. 37. The method according to any one of claims 33-36, wherein the skin areas include the cheek and forehead. 38. The method according to any one of claims 33-37, wherein the domains further include one or more electrically improper contact domains corresponding to various respective states in which the electrodes are not in proper electrical contact with the skin, the method further comprising : set another parameter value; establish that the other value belongs to one of the domains of improper electrical contact, and stop processing the skin in response to establishing that another value belongs to the domain of improper electrical contact. 39. The method of claim 38, wherein the states include a state in which the electrodes are not in electrical contact with the skin. 40. The method according to any one of claims 38, 39, wherein the states include a state in which the electrodes are in electrical contact with the skin, but not through a gel layer having a thickness in a predetermined range. 41. The method according to any one of claims 38-40, further comprising generating an output signal indicative of a state to which the improper electrical contact domain corresponds. 42. The method according to any one of claims 27-41, wherein the set values include skin temperature temperature values. 43. The method of any one of claims 27-42, further comprising measuring at least some of the RF currents and, in response, generating an output signal, the method comprising setting set values in response to the output signal. 44. The method of claim 43, wherein the set values include electrical current property values, such as amplitude or phase, for at least some of the RF currents. 45. The method of any one of claims 27-44, further comprising measuring a voltage associated with at least some of the RF currents and generating, in response, an output signal indicative of a voltage, the method comprising setting set values in response to the indicative voltage output signal. 46. The method of claim 45, wherein the set values include voltage property values for a voltage property, such as amplitude or phase of the voltage. 47. The method of any one of claims 27-46, wherein the set values include impedance values for skin impedance. 48. The method according to any one of claims 27-47, further comprising, prior to treating the skin, causing a pretreatment electric current to pass through the skin between any pair of electrodes, wherein the method includes setting an initial one of the set values based on the pretreatment electric current. 49. The method according to any one of claims 27-48, further comprising: comparing the quantity derived from the set values with the base quantity, and in response to the comparison, generating an output for the user. 50. The method of claim 49, wherein the output signal includes a message indicating a characteristic of the skin. 51. The method according to any one of claims 49, 50, wherein the output signal includes a recommendation for a skin care product.

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