Modulated waveform treatment device and method

Abstract

A microcurrent treatment device has one or more electrodes or emitters configured to be in electrical communication with a skin surface of a subject. A voltage or current source is adapted to generate an electrical or other energy waveform to be applied to the skin surface through the one or more electrodes or emitters, and a controller is configured to modulate the waveform. The controller can modulate successive pulses of the waveform such that the pulse width, period, frequency, amplitude, or integrated amplitude of the successive pulses varies in a pre-defined, random, pseudo-random, or other non-periodic manner, or such that the pulses exhibit a degree of statistical randomness over a pre-defined period. The period can cover a group of successive pulses defining a treatment period, or can cover successive subsets of successive pulses defining one or more phases of a treatment period.

Description

[0001] Cross-referencing related applications

[0002] This invention claims priority to U.S. Provisional Application No. 63 / 004,839, filed April 3, 2020, entitled “Microcurrent Skin Care Device and Method”, the entire contents of which are incorporated herein by reference and used for all purposes. Technical Field

[0003] This invention relates to waveform modulation, and modulated waveforms for microcurrent skin care and other energy stimulation. More generally, this invention relates to systems, apparatuses, methods, and functions for modulating electrical waveforms and energy stimulation, as well as improvements to these techniques. Suitable uses include, but are not limited to, pulsed modulated waveforms suitable for microcurrent skin care techniques, and other modulations of electrical and energy stimulation. Uses of these improved techniques include cosmetic skin care and skin care applications, and other cosmetic and beauty applications suitable for meeting applicable regulatory requirements. Background Technology

[0004] The skin is the largest organ in the human body. It forms a physical barrier against the environment and provides important functions, including insulation, temperature regulation, protection against microorganisms, and tactile, thermal, and other forms of sensation. The skin also regulates the passage of water and electrolytes and produces vitamin D.

[0005] The outermost layer of skin, or epidermis, covers the surface of the body. Most epidermal cells are keratinocytes, which form an environmental barrier and synthesize vitamin D. The epidermis also includes: melanocytes, which produce melanin to protect against harmful UV radiation; Merkel cells, which provide touch; and Langerhans cells (a type of white blood cell or macrophage), which are part of the immune system and play a role in protecting the body against infection.

[0006] The epidermis surrounds the dermis. The structure of the dermis is provided by fibroblasts, which synthesize collagen and elastin to form the extracellular matrix. Collagen fibers provide strength and toughness, while elastin threads or elastin filaments provide elasticity and flexibility. Fibroblasts also produce proteoglycans, a type of sticky protein that plays a role in hydration and lubrication, and regulates ion binding and molecular transport. The dermis also includes macrophages and mast cells (components of the immune system), as well as hair follicles, sweat glands and sebaceous glands, nerve cells, and blood vessels.

[0007] The epidermis and dermis make up the skin. Subcutaneous tissue connects the skin to deep muscles and fascia, and also connects the skin to other connective tissues, including the periosteum (which covers the bones). Subcutaneous tissue also includes elastin and fat cells.

[0008] As skin ages, the loss of firmness and elasticity may be associated with reduced production of type I collagen (the most abundant form) as well as decreased levels of elastin, proteoglycans, and other components of the extracellular matrix. Skin aging can also manifest as thinning, discoloration, and a decreased immune response.

[0009] A range of personal skincare products have been provided to help mitigate certain effects of aging, including topical products and handheld devices for cleansing, exfoliating, and smoothing the outer layers of skin. In addition, various current-based (electric current-driven) care devices are known, for example, as described in U.S. Patents Nos. 5,147,297A, 5,162,043A, 5,298,017A, 5,326,341A, and 5,405,317A, originally assigned to Alza Corporation of Palo Alto, California; U.S. Patent No. 5,685,837A, originally assigned to LTS-Lohman Therapie-Systeme of Neuwiede, Germany; U.S. Patent No. 6,584,349B1, originally assigned to Viteris, Inc. of Philland, New Jersey; and U.S. Patents Nos. 6,421,561B1 and 6,653,014B2, originally assigned to Birch Point Medical of Oakdale, Minnesota. Other stimuli may also exist, such as the form of light energy described in U.S. Patent No. 9,079,022B2, originally assigned to LEDIntellectual Properties, Irvine, California.

[0010] In a current system, one or more anodic or cathode electrodes are arranged to generate a potential on the skin to provide a current flowing through the epidermis and dermis. Advanced devices based on microcurrents may include control circuitry operatively connected to the electrodes to finely modulate the current, thereby facilitating ion transport and other biological effects; for example, as described in U.S. Patent Nos. 7,653,970B1 and 10,046,160B1, assigned to NSE Products, Prover, Utah, and U.S. Patent Publication No. 2007 / 0185431A1, the entire contents of which are incorporated herein by reference and used for all purposes.

[0011] More generally, the skin's response to electrical currents involves many complex and interacting biological processes, and current technologies have not fully identified the full range of different care mechanisms. Therefore, there is a continued need for more advanced skin care methods, including microcurrent-based skin care technologies developed with the help of a better understanding of the underlying biological responses, and modulated electrical waveforms and energy stimulation to improve care responses and enhance user comfort. Summary of the Invention

[0012] A microcurrent skin care device is provided, comprising one or more electrodes or transmitters configured to electrically communicate with the skin surface of a subject. A voltage or current source is adapted to generate an electrical waveform for application to the skin surface via the one or more electrodes or transmitters. A controller may be configured to modulate continuous pulses of the electrical waveform such that one or more of the pulse width, pulse period, pulse frequency, and pulse amplitude vary with random or pseudo-random components or in other non-repetitive or non-periodic manner.

[0013] For example, in a particular implementation, a different set of pulse parameters can be selected to modulate the waveform. These parameters can be randomly ordered using a pseudo-random number generator or other non-repeating ordered set of variables and applied to continuous pulses to modulate the pulse width, pulse period, pulse frequency, or pulse amplitude of the waveform, or any combination thereof.

[0014] Alternatively, one or more selected pulse parameters can be modulated by random or pseudo-random components, or one or more selected pulse parameters can be varied in a non-repetitive or non-periodic manner, regardless of the order in which the pulses are applied. Furthermore, methods for operating microcurrent skin care devices, as well as randomization functions and processes for modulating the applied waveform, are also covered. Other advantages and features of these techniques are set forth in the detailed description below and will be apparent to those skilled in the art upon examination of the specification, drawings, and claims. Attached Figure Description

[0015] Figure 1 It is a cross-sectional view showing representative components of human skin;

[0016] Figure 2 It is a cross-sectional view showing the electric current flowing through a representative layer of skin;

[0017] Figure 3 This is a block diagram of a microcurrent skin care device;

[0018] Figure 4 This is a block diagram of a method for microcurrent skin care;

[0019] Figure 5 This is a block diagram of a method for pulse waveform modulation;

[0020] Figure 6 It is the amplitude-time plot of a waveform with random pulse width modulation;

[0021] Figure 7A It is the amplitude-time diagram of a random pulse width modulation waveform with a fixed carrier frequency;

[0022] Figure 7B It is the amplitude-time plot of a pulse width modulation waveform with matched switching pulse widths;

[0023] Figure 8A It is an amplitude-time graph of a waveform modulated by a random pulse frequency;

[0024] Figure 8B It is an amplitude-time diagram of a waveform with random pulse amplitude modulation;

[0025] Figure 9 It is an amplitude-time diagram of a waveform with random pulse width, pulse frequency, and pulse amplitude modulation;

[0026] Figure 10 It is a block diagram of functions or processes used for random pulse width, pulse frequency, and pulse amplitude modulation;

[0027] Figure 11A This is a front view of one embodiment of a handheld device for generating and applying modulated waveform stimulation as described herein;

[0028] Figure 11B yes Figure 11A Side view of the device shown;

[0029] Figure 12A and Figure 12B This is a bar graph showing the exemplary application results of a device for generating modulated waveform stimulation, as described herein, based on a user's self-assessment of the first set of care criteria.

[0030] Figure 12C and Figure 12D This is a bar chart showing the results based on the first set of criteria according to clinical grading.

[0031] Figure 13A and Figure 13B This is a bar graph showing the exemplary application results of the device for generating modulated waveform stimulation, as described herein, based on the user's self-assessment of the second set of care standards.

[0032] Figure 13C and Figure 13D This is a bar chart showing the results based on the second set of criteria according to clinical grading.

[0033] Figure 14A and Figure 14B This is a bar graph showing the exemplary application results of a device for generating modulated waveform stimulation, as described herein, based on a user's self-assessment of the third set of care standards.

[0034] Figure 14C and Figure 14D This is a bar chart showing the results based on the third set of criteria according to clinical grading.

[0035] Figure 15A and Figure 15B These are tables and bar charts summarizing laser Doppler flux measurement data according to exemplary applications of devices for generating and applying modulated waveform stimulation as described herein;

[0036] Figure 16A and Figure 16B They are summaries Figure 15A and Figure 15B Tables and bar charts showing temperature measurement data for representative applications are provided.

[0037] Figure 17 This is a table summarizing tolerance study data for exemplary applications of devices used to generate and apply modulated waveform stimuli as described herein. Detailed Implementation

[0038] While this disclosure describes specific embodiments and preferred embodiments of the invention, those skilled in the art will recognize that changes in form and detail may be made without departing from the scope of the claims. Furthermore, various embodiments and implementations are described in conjunction with the accompanying drawings, wherein the same reference numerals denote the same structural and functional components throughout several views. These embodiments and implementations do not limit the practice of the invention as described in the claims; rather, the specification merely sets forth representative applications of different systems, methods, and apparatuses, and the practice of the invention is not limited unless set forth in the appended claims.

[0039] Waveform modulation for energy skin stimulation

[0040] Modulated waveforms can be used to define a range of energy stimulations suitable for skin care and treatments, including current- and microcurrent-based treatments, as well as other voltage- or current-based devices. Waveform modulation can also be used to generate LED, laser, or other electromagnetic stimulations, or ionizing radiation treatments, in the frequency ranges of radio frequency (RF), infrared (IR), near-ultraviolet (near-UV), or ultraviolet (UV), as required by all applicable laws and regulations, for cosmetic, non-cosmetic, medical, or non-medical applications. Furthermore, it can generate, for example, acoustic stimulation in the subsonic, sound, or ultrasonic range, or a combination of voltage, current, electromagnetic, and acoustic stimulation can be applied.

[0041] While various relationships between modulation signal amplitude, treatment duration, and efficacy have been explored in some existing technologies, significant design challenges remain in this area. Specifically, there are no well-defined modulation parameters that can be uniformly applied to improve the efficacy of a particular skin care treatment across all the different potential ranges of applied stimulation. Furthermore, no broader signal modulation techniques have been identified to improve treatment efficacy while reducing user discomfort and avoiding potential homeostatic trends that could significantly impact treatment outcomes over time.

[0042] These problems can be partially or completely solved using random or pseudo-random waveform modulation methods. By employing this method, a set of pulses in a waveform can be modulated or controlled in a random, pseudo-random, or non-periodic manner to vary with pulse width, period, frequency, or amplitude. This modulation can include pseudo-random variations based on computational algorithms, or "real" random variations based on probabilistic physical phenomena (e.g., atmospheric or thermal noise, background fluctuations, radioactive decay, or other quantum phenomena) and suitable for providing a statistically random sequence of pulse variations known in the art as described in this specification.

[0043] Random waveform modulation can be locally confined to a given set of pulses within a care cycle or phase, or more globally confined to multiple such phases constituting a care cycle. Quantum-computer-based randomization can also be used to generate random pulse variations, or more generally, a combination of random, pseudo-random, and quantum-based effects can be chosen to provide statistically random pulse parameters; for example, in non-repetitive or non-periodic sequences, or in the absence of other identifiable patterns or regularities, any form of randomness of a waveform that results in some quantity of statistical randomness (in at least some aspects of the waveform) known in the art when analyzed over a relevant time period. Random or pseudo-random sequences can be determined in real time or predefined (e.g., one or more such sequences can be determined using a random or pseudo-random generator) and then reordered to be applied to a subset of continuous pulses constituting each phase, or to the entire set of continuous pulses constituting a care cycle.

[0044] This random waveform modulation method can significantly improve skin health and appearance, while also improving user comfort and potentially mitigating potential homeostatic shifts—the tendency to adjust to a relatively stable equilibrium in response to applied stimuli. As described below, these improvements can be defined using quantitative user assessments (a measure highly relevant to individual skin care and maintenance techniques) across a broad range of care standards and based on well-defined clinical trial data (using objective, blinded, clinically graded results independent of user assessments).

[0045] Application of apparatus and methods

[0046] Figure 1This is a cross-sectional view showing representative structural and functional components of human skin 100. (Example) Figure 1 As shown, skin (or "skin") 100 includes an upper epidermal layer (or epidermis) 105 that extends from the skin surface 101 to the lower dermis (dermis) 110. The epidermis 105 and the dermis 110 together constitute skin tissue or skin. Subcutaneous tissue includes subcutaneous tissue (or hypodermal tissue) 120 located beneath skin 100.

[0047] Collagen fibers 125 extend from the lower dermis 110 to the subcutaneous tissue 120, forming multiple strips and sheets of connective tissue (fascia) connecting the skin (or dermis) 100 to the deep muscles and connective tissue. The dermis 110 also includes a papillary layer 111 and a reticular layer 112, which are formed by loosely arranged collagen fibers and denser collagen fibers, respectively.

[0048] Subcutaneous tissue 120 includes, for example, fat storage cells (adipocytes) and adipose tissue 130 in the form of intracellular or intercellular lipids, which may form lobules 135 and other structures between collagen fibers 125. A network of small blood vessels or capillaries 140 provides circulation extending from subcutaneous tissue 120 to dermis 110.

[0049] Figure 2 This is a cross-sectional view showing electrical stimulation 150 propagating through different layers of skin 100. For example, in one embodiment, current or microcurrent stimulation 150 may be generated by one or more electrodes or transmitters 155 disposed along the skin surface 101. Gel or other topical skin care product 160 may be applied to the skin surface 101 to increase conductivity and provide nutrients and other beneficial substances to the skin 100. Furthermore, electromagnetic energy may also be used as a form of stimulation 150 to care for the skin, for example, in the form of radio frequency (RF), infrared (IR), optical, or ultraviolet (UV) radiation (e.g., low-energy near-UV); or, energy stimulation 150 may be provided in the form of sound waves, subsonic, or ultrasonic acoustic energy. These energy stimuli may be presented to the skin as modulated waveforms, similar to modulated waveforms provided in the form of electrical or current stimulation 150. Therefore, forms of electrical, electromagnetic, and acoustic energy are all within the scope of the teachings of this disclosure, and any suitable combination of these energy stimuli may be presented in the form of modulated waveforms.

[0050] like Figure 2As shown, for example, electrical stimulation 150 can be generated by applying a potential V (or current source I) between two or more electrodes or transmitters 155 spaced apart along the outer surface 101 of skin 100 and adjacent to or in direct contact with skin surface 101. Alternatively, one or more electrodes 155 may be positioned at a specific location on or near skin surface 101 (e.g., on the face, arm, torso, or leg) and remotely coupled to another electrode 155, for example, through contact with the user's (or other care subject's) hand or other parts of the subject's body. In other applications, electrical stimulation 150 can be applied using a single electrode 155, for example, by applying an ungrounded (floating) potential waveform from one or more electrodes 155 to skin surface 101; or by forming a current loop through the subject's foot or other grounded contact.

[0051] Depending on the application, a potential V can be supplied to the electrode or emitter 155 to apply an electrical stimulation 150 to the upper epidermal layer 105 of the skin 100, or to one or both of the (upper) papillary layer 111 and (lower) reticular layer 112 of the dermis 110, with the current propagating through the epidermal layer 105. The electrical stimulation can also propagate to or through the subcutaneous tissue 120, thereby promoting a favorable response from the skin tissue and subcutaneous tissue. Thus, stimulation 150 can promote a range of biological responses in the epidermis, dermis (skin) tissue, and subcutaneous tissue. Alternatively, one or more electrodes or emitters 155 can take the form of: an LED or laser light source (or other electromagnetic emitter) configured to provide stimulation in the form of RF, IR, optical, or UV light energy; or one or more acoustic transducers configured to provide subsonic, ultrasonic, or other acoustic stimulation; or any suitable combination of electrical emitters, acoustic emitters, and electromagnetic emitters 155.

[0052] In a specific example, a DC (direct current) or pulsed DC potential V or a current I is applied through electrode 155, causing electrical stimulation 150 to propagate through skin 100 in a specific direction. In other examples, an alternating current (AC) potential V may be applied, causing electrical stimulation 150 to propagate back and forth in an alternating manner.

[0053] The potential V can be applied as a steady-state (constant or alternating) voltage signal or using a modulated waveform. Depending on the application, the pulse width, amplitude, period, and frequency of the applied voltage V or current I can be controlled individually or in combination to generate electrical stimulation 150 as AC, DC, or pulsed DC current care for the skin 100 of a user or other subject. In specific applications, pulse width modulation (PWM) can be used to generate stimulation 150 as a pulsed microcurrent signal, or it can be used to generate other energy stimulation 150, for example, by applying a programmed random or pseudo-random pulse width modulation (PRPWM) current or voltage waveform, or as a modulated electromagnetic or acoustic waveform, as described herein.

[0054] Figure 3 It is based on Figure 2 The diagram shown represents a typical device or apparatus 300 configured for microcurrent-based skin care or other energy stimulation 150. Figure 3 As shown, the microcurrent device 300 includes: a housing 305 with a power supply (P / S) 310; a current or voltage generator (V / I) 320 electrically connected to one or more electrodes or other transmitters 155; a microprocessor-based (μP) controller 330; a memory 340; and an external communication interface 350.

[0055] The power supply 310 may be provided in the form of a rechargeable capacitor or battery system, for example, having a power port 315 suitable for external wired or wireless (e.g., inductive) charging. The microprocessor controller 330 communicates with a memory 340, which stores control code 345 and operational data 348. The communication interface (I / F) 350 may be adapted to communicate with the controller 330 for data and control purposes, for example, using a hardwired communication port or a wireless device 355.

[0056] In operation of device 300, power supply 310 provides power to voltage or current generator (or source) 320, as well as microprocessor controller 330, memory 340, and interface 350. Controller 330 is configured, for example, to regulate the potential (V) or current (I) signal generated by source 320 by executing control code 345 stored in memory 340. Control parameters and other operational data 348 can be used to modulate the signal provided to each selected electrode or transmitter 155 to deliver the desired amplitude, frequency, and pulse width modulation. Additionally, one or more skin sensors 158 may be provided, for example, to measure skin surface temperature and resistivity, and to determine other skin conditions such as hydration. Furthermore, additional sensors 158 may be provided to measure or monitor environmental conditions such as ambient temperature and humidity.

[0057] The microprocessor controller 330 may also be adapted to monitor feedback signals from the electrodes or transmitters 155 and adjust the applied potential (V) or current (I) in response to the feedback. This feedback-based adjustment allows the controller 330 to maintain the desired electrical stimulation 150, taking into account the number and arrangement of the electrodes 155, as well as the subject's skin type and relevant skin conditions, such as resistivity, temperature, hydration, etc., determined using additional data from one or more skin sensors and other environmental sensors 158. The controller 330 may also be adapted to adjust the current stimulation 150 transmitted through the subject's skin based on the voltage (V) or current (I) signal actually applied to the electrodes 155, other operational and environmental conditions (e.g., the presence of conductive gel or other skin care products between the electrodes 155 and the skin surface), and other recent and historical care information recorded in the operational data 348.

[0058] Figure 4 It is shown (for example) using Figure 3 The diagram shows a representative method or process 400 for performing microcurrent-based skin care using the device 300 shown. Figure 4 As shown in a specific example, method 400 includes one or more steps: determining operational data (step 410); defining a stimulus (step 420); generating a waveform (step 430); modulating the waveform (step 440); and applying the stimulus based on the modulated waveform (step 450).

[0059] Depending on the application, method 400 may also include monitoring feedback (step 460) and adjusting the modulated waveform (step 470), for example, to reduce the difference between the defined stimulus and the applied stimulus. These steps may be performed in any order or combination, with or without additional procedures. For example, monitoring feedback (step 460) may also include monitoring sensor data, for example, to determine skin condition (step 480) and environmental conditions (step 490).

[0060] Determining the operational data (step 410) can be performed as an initialization or startup operation of method 400, for example, by reading the operational data from memory. The operational data may include a set of operational parameters for performing the steps of method 400, or data for generating this set of parameters. For example, the operational data may include stimulation data or parameters from which a desired stimulus can be selected or defined (step 420), and waveform data or parameters from which a desired voltage or current waveform can be generated (step 430).

[0061] The waveform data may also include a selected set of pulse parameters for modulating the waveform (step 440), thereby enabling the desired stimulus to be delivered or applied to the subject's skin (step 450). The pulse parameters may be selected to characterize one or more pulse widths of the "on" and "off" portions of the cycle, as well as the pulse period, frequency, and amplitude.

[0062] The applied waveform can be unipolar or bipolar; for example, the sign can be determined based on the sign definition of the amplitude parameter, or by defining the absolute (non-negative) amplitude using a separate polarity parameter. Pulse modulation can be randomized to produce non-repetitive or aperiodic modulation pulse sequences by assigning selected parameters to continuous pulses in a random or pseudo-random sequence, or by including random or pseudo-random components in the modulation pulse parameters themselves.

[0063] For example, pulse width, period, frequency, amplitude, or other modulation pulse parameters can be aperiodic or non-repetitive over a given set of pulses, such that the modulation parameters do not repeat at all within a given subset or set, or do not repeat in any identifiable pattern or sequence. Aperiodic or non-repetitive pulse parameters can be modulated over a continuous set of pulses defining a care cycle with one or more care phases, or over a continuous subset of pulses defining one or more phases.

[0064] The applied stimulus can be monitored (step 450) by measuring the voltage or current applied through electrodes or other transmitters. Feedback parameters can be used to adjust the modulated waveform (step 470), for example, by applying hardware- or software-based gain parameters to reduce any discrepancies between the defined stimulus (step 420) and the actually applied stimulus (step 450). Monitoring the feedback (step 460) may also include receiving sensor data for determining skin and environmental conditions, such as resistivity, surface temperature, hydration, ambient temperature, humidity, etc. (steps 480 and 490).

[0065] The operational data (step 410) may also include historical log data of previous operations performed on the appropriate microcurrent device 300 according to method 400. For example, log data may be recorded to characterize previously defined stimuli (step 420) and parameters for waveform generation (step 430) and modulation (step 440). Additional log data may provide records of: stimuli actually delivered or applied in previous care (step 450), electrode or transmitter and sensor feedback (step 460), and additional parameters for: adjusting the modulation waveform (step 470); determining resistivity and other skin conditions (step 480); and describing relevant environmental conditions (step 490).

[0066] Waveform modulation (step 440) can be performed using various pulse modulation techniques. For example, in the radio frequency (RF) range, amplitude modulation (AM) and frequency modulation (FM) techniques are commonly used. In these techniques, the modulated waveform is typically a sinusoidal carrier generated at a specific carrier frequency (e.g., in the range of kilohertz (kHz), megahertz (MHz), or gigahertz (GHz)).

[0067] In amplitude modulation (AM) technology, the amplitude of the carrier wave can vary according to an analog (e.g., audio) signal. The modulated carrier signal is demodulated at the receiver, thus separating the information-carrying modulation frequency from the carrier wave. For analog modulation with an audio range of approximately 1-10 kHz, typical carrier frequencies extend from tens of kilohertz (kHz) to tens of megahertz (MHz) or higher.

[0068] In frequency modulation (FM) technology, the instantaneous frequency of the carrier wave, rather than its amplitude, changes. For audio range applications, FM carrier frequencies typically extend from about 10 MHz or higher to the gigahertz (GHz) range. Furthermore, frequency shift keying (FSK) can be applied in both lower and higher frequency ranges, for example, to encode digital signals by shifting the carrier frequency between a selected set of discrete adjacent frequencies.

[0069] In skin care applications, stimulation is not limited to narrowband carrier waves and can also be defined based on a pulse waveform (step 430) (step 420). A programmed random pulse waveform modulation (PRPWM) can be applied to the pulse waveform (step 440) to deliver the desired stimulation (step 450) to the subject's skin. Programmed random pulse waveform modulation can also be adapted to ensure charge and power balance, combined with a deeper understanding of the underlying biological mechanisms of the body, including the effects of random pulse width modulation on homeostasis.

[0070] Pulse waveform modulation

[0071] Figure 5 This is a block diagram of a method or process 500 for pulse waveform modulation. For example, such as... Figure 3 As shown, method 500 can be used to operate device 300 having one or more electrodes or transmitters 155; as Figure 2 As shown, method 500 is adapted to apply pulsed modulated electrical stimulation 150 to the skin of a subject. Similarly, for example, according to Figure 4 The methods 400 and 500 shown can also be adapted to modulate waveforms for microcurrent-based skin care.

[0072] like Figure 5As shown, method 500 includes: generating a pulse waveform (step 530); modulating the waveform (step 540); and applying a pulse-modulated stimulus (step 550). These steps can be performed in any order or combination, with or without additional processes. For example, method 500 may also include: monitoring a combination of sensors and electrical feedback (step 560); and adjusting the modulated waveform according to the feedback (step 570), for example, to match a predefined and applied stimulus according to steps 420 and 430 through 470 of method 400.

[0073] Generating a pulse waveform (step 530) includes, for example, using... Figure 3 The voltage or current generator 320 shown provides a pulsed electrical signal. The pulse waveform can be a sinusoidal or non-sinusoidal waveform (e.g., square wave, rectangular wave, sawtooth wave, or triangular wave), or other periodic or non-periodic functions. The waveform can also be generated in positive or negative polarity or in bipolar form, and can be grounded as a reference or superimposed on a DC signal with positive or negative bias.

[0074] Pulse waveform modulation (step 540) includes a series of modulation techniques, including pulse width modulation (PWM; step 545), pulse frequency modulation (PFM; step 546), pulse amplitude modulation (PAM; step 547), and combinations thereof. In a specific example, random or pseudo-random pulse width modulation (RPW) 548 may be applied to enhance biological responses (step 550) and reduce homeostatic tendencies when stimulation is applied to the subject's skin.

[0075] Pulse width modulation (PWM; step 545) is a technique for selectively distributing power across individual pulses in a pulse waveform or carrier wave according to a desired (e.g., analog or digital) modulation function. The average value of the delivered power is determined based on the time integral of the modulated voltage and current waveforms, while the instantaneous power is determined by the corresponding amplitude at a specific time. Since the pulse width is also reflected in the length or duration of the signal, pulse width modulation can also be described as pulse duration modulation (PDM).

[0076] In Pulse Frequency Modulation (PFM) 546, the frequency of the pulse waveform can vary independently of the pulse width and amplitude, or a combination thereof. The frequency variation is reflected by periodic changes between consecutive pulses and can be performed based on analog or digital modulation signals, for example, by Frequency Shift Keying (FSK), where the pulse-to-pulse frequency varies between a selected set of discrete digital frequency variations.

[0077] In Pulse Amplitude Modulation (PAM) 547, the amplitude of the pulse waveform (or carrier) can vary from pulse to pulse independently of one or more of, or in combination with, the pulse width, pulse period, and carrier frequency. Pulse Amplitude Modulation (PAM) can also be applied as an analog or digital modulation technique, for example, via Amplitude Shift Keying (ASK), where pulses are modulated according to a selected set of discrete amplitudes, each of which is assigned a different digital value.

[0078] In random pulse width modulation (RPW; step 548), the width of each waveform pulse is modulated according to a random or pseudo-random scheme. The pulse width and duty cycle of the waveform can be randomized independently of the pulse frequency and amplitude, or these techniques can be used in combination, as described below.

[0079] like Figure 3 As shown, the modulated waveform can be applied in the form of voltage or current (step 550), for example, delivered to the subject's skin via one or more electrodes or transmitters 155. Furthermore, feedback from electrodes 155 and one or more sensors 158 can be monitored (step 560) to determine the difference between the defined stimulus and the actually applied stimulus.

[0080] The modulated pulse width can be adjusted based on feedback (step 570) to match the applied stimulation with the desired effect. For example, the amplitude of a given voltage stimulation can be adjusted based on the skin's resistivity to deliver the desired current stimulation. Alternatively, any combination of the pulse width, frequency, and amplitude of the applied stimulation can be adjusted based on temperature, hydration level, and other skin and environmental conditions, or based on the presence of local care between the care electrode (or other transmitter) and the skin surface.

[0081] Random Pulse Modulation

[0082] As described above, the random pulse width modulation (RPW) 548 may also include any combination of pulse width modulation (PWM) 545, pulse frequency modulation (PFM) 546, and pulse amplitude modulation (PAM) 547. For example, using a machine-based pseudo-random number generator (PRNG) or a hardware-based (“real”) random number generator (HRNG), a set of individual “on” and “off” pulse widths can be defined within a specific range and then randomly ordered to be applied to a continuous pulse in the waveform.

[0083] Alternatively, the pulse width can be defined using random or pseudo-random components, and the pulse width can be applied sequentially to consecutive pulses with or without an additional sequential randomization step. Furthermore, similar randomization techniques can be used to modulate pulse amplitude, pulse period, and frequency, thereby producing modulated waveforms with any suitable combination of constant, deterministic, and random or pseudo-random pulse amplitude, frequency, and width.

[0084] For example, if the total pulse period (“on” plus “off” period) is fixed, the pulse width can nominally be modulated independently of the instantaneous (pulse-to-pulse) carrier frequency, although the varying pulse width will still be reflected in the Fourier transform. If the total period (“on” plus “off”) is not fixed, both the pulse width and the instantaneous carrier frequency vary from pulse to pulse. Similarly, while the pulse amplitude can nominally be modulated independently of the pulse width and the instantaneous carrier frequency (based on the pulse-to-pulse period), the frequency of any amplitude modulation will be reflected as a sideband in the Fourier transform. All these random modulations of the applied stimulus can enhance the skin’s response and provide additional benefits to skin care, as described in the various examples herein.

[0085] Random Pulse Modulation

[0086] Figure 6 This is an amplitude-time graph of a pulse width modulation (PWM) waveform with random pulse width modulation (RPW) 600. The vertical axis represents pulse amplitude, expressed in arbitrary units. The horizontal axis represents time, also expressed in arbitrary units.

[0087] exist Figure 6 In a specific example, programmed random pulse width modulation (PRPWM) is used. Waveform 600 is generated as a series of individual pulses 610 (where the modulated “on” pulse widths W = Wi, Wj, etc.) and corresponding “off” pulse segments 615 (widths W’ = Wi’, Wj’, etc.). The nominal pulse amplitude is substantially constant when A = A0. The instantaneous carrier frequency f = 1 / T varies from pulse to pulse according to the total (on + off) period T; that is, Ti = Wi + Wi’, Tj = Wj + Wj’, and so on.

[0088] The pulses 610 in waveform 600 can be generated in unipolar or bipolar form. For example, waveform 600 can define a care cycle comprising one or more alternating sequences or phases 620 and 625 of continuous positive or negative polarity pulses 610, wherein the individual pulses 610 are generated by… Figure 6 The “off” segments 615 shown are separated. In this particular example, pulse 610 has a positive amplitude +A0>0 in the first (positive) phase 620 and a negative amplitude –A0<0 in the second (negative) phase 625.

[0089] In unipolar applications, waveform 600 can define a care cycle comprising multiple positive pulses 610 (amplitude +A0>0) arranged in one or more positive phases 620, or multiple negative pulses 610 (amplitude –A0<0) arranged in one or more negative phases 625. The number of pulses and amplitudes can vary from phase to phase, and the polarity of the phases (620, 625) can be reversed without loss of generality. Pulses 610 can also be generated in a bipolar form, for example, positive pulse slices converted to negative pulse slices, or vice versa; and a bias voltage can be applied to a reference amplitude, wherein the pulse amplitude ±A0 is measured according to the bias voltage value.

[0090] exist Figure 6 In a specific example, the "on" pulse width (W = Wi, Wj) and the "off" segment width (Wi', Wj') vary relative to the nominal width W0, depending on the random or pseudo-random modulation function. The first phase 620 may have the same (N) number of pulses 610 as the second phase 625, or a different number, and the sequences of pulse widths (Wi, Wi', Wj, Wj') may be the same or different. For example, the same set of random pulse widths (Wi, Wi', Wj, Wj') may be used in the same order for both phases (620, 625), such that the pulse sequences are identical except for polarity, and the period (Ti, Tj) and the on / off pulse widths (Wi, Wi'; Wj, Wj') are identical for each pulse sequence 610 in the positive phase 620 and the negative phase 6250 using the same order. Alternatively, the pulse width sequence can be randomized, shifted or reversed, or otherwise varied from phase to phase such that (Ti, Tj) and the on / off pulse widths (Wi, Wi'; Wj, Wj') vary in any order from pulse to pulse 610 in each phase (620, 625).

[0091] Power and duty cycle

[0092] The power transmitted by waveform 600 depends on the pulse frequency (f = 1 / T0), pulse height or amplitude (A), and duty cycle, which is determined by the width of the “on” and “off” slices of each pulse 610 (Wi, Wi’, Wj, Wj’, etc.). In current-based applications, the power can be expressed as the product of current and voltage, P = I × V, where the pulse amplitude typically represents either voltage (V) or current (I), or power itself (P). More generally, skin tissue may have a complex impedance reflecting a combination of resistive and reactive (capacitive and inductive) effects, and the power function will take into account the frequency and phase of the current and voltage signals.

[0093] The duty cycle of the modulated waveform 600 is determined by the “on” pulse width (Wi, Wj) relative to the corresponding period (Ti, Tj) within the total care time in each phase (620, 625). For example, in a square wave pulse, the widths of the “on” and “off” pulse slices are equal, and the duty cycle is 50%. For the modulated random pulses described herein, the duty cycle can vary with the pulse and phase, or the duty cycle can be limited to a specific value based on the integral pulse width for each phase, for example, about 50%, a few percent or less (≤1–10%), or up to 90% or more (≥90%). Furthermore, similar techniques can be applied to modulate the pulse period (T) and amplitude (A) to primarily maintain charge balance.

[0094] In specific applications, each phase (620, 625) may include one to ten or more individual pulses 610(N), thereby providing current (I) up to 100-250 microamps (μA) or higher. The individual “on” and “off” pulse widths (Wi, Wi’, Wj, Wj’) can vary from a few milliseconds or less (T≤1–10ms) to a fraction of a second or more (T≥0.1–1.0s).

[0095] Because the pulse width is randomized, the power function also varies from pulse to pulse, and the variations within a specific phase and over consecutive phases (620, 625) can be aperiodic (or non-repetitive). For example, the pulse width can be modulated within a selected range of the nominal width W0; for example, from about 0.20 × W0 or 0.50 × W0 to about 2.0 × W0, or from about 0.1 × W0 to about 10 × W0, or from about 0.01 × W0 (or less) to about 100 × W0 (or greater).

[0096] More generally, the pulse width, period, frequency, or amplitude (or other modulation pulse parameters) can vary within a similar range compared to the average or nominal value of the modulation parameters. The average nominal value can be defined or determined on a subset of continuous pulses defining a phase of a selected care cycle, or on a group of continuous pulses defining the care cycle itself. Variations in modulation pulse parameters can be 1% or less of the nominal or average value, or at least 1% of the average or nominal value. Variations in modulation pulse parameters can be at least 10% or at least 20% of the nominal or average value, for example, up to 50%, 100%, or twice the nominal or average value. Variations in modulation pulse parameters can also extend to ten times or one hundred times or more of the nominal or average value.

[0097] This variation can be a non-periodic, non-repetitive manner on a given set or subset of pulses, such that the modulation parameters do not repeat at all within the given subset or set, or do not repeat in any identifiable pattern or sequence. A set or subset of continuous pulses 610 can be defined on a care cycle comprising one or more care phases (620, 625) or on one or more phases (620, 625) within a care cycle. For example, the pulse width (or other pulse parameters) can be assigned to the continuous pulses 610 in each phase (620 or 625) using random, pseudo-random, or predefined sequences, such that the pulse parameters are non-periodic or non-repetitive within each individual phase (620, 625) or on one or more phases (620, 635) constituting a care cycle.

[0098] Alternatively, as defined globally, the pulse parameters can be non-repetitive or aperiodic on a complete set of pulses 610 that define a care cycle comprising any number of individual phases (620, 625). For example, a suitable random or pseudo-random sequence can be defined in real time and assigned to consecutive pulses 610 in one or more phases (620, 625); or, a suitable sequence can be predefined using a random or pseudo-random pattern and then rearranged or reordered for each phase (620, 625). Furthermore, random or pseudo-random components can be assigned to individual pulses 610, or predefined random or pseudo-random sequences or patterns can be used such that the modulation parameters are non-repetitive or aperiodic on individual pulses in each phase (620, 625) or on a care cycle comprising any number of such phases.

[0099] The nursing time varies depending on the pulse frequency (F) and period (T), as well as the number of individual pulses 610 in each phase (620, 625). In some applications, for example, 10 or more (N≥10) pulses 610 may be sequentially distributed across each phase (620, 625) with an average pulse period of approximately 120 ms and transmitted over a time period of approximately 1.2 s (1200 ms). Alternatively, the number of pulses per phase may range from 1 to approximately 100 or more. The average pulse period may range from approximately 50 ms or less to approximately 500 ms or more, corresponding to nursing times ranging from 1 second or less to 10 seconds or more.

[0100] The total treatment cycle time depends on the average pulse period, the number of pulses per phase, and the number of phases applied. A typical treatment cycle can include up to 10 or more phases for each required polarity, with the total treatment cycle time ranging up to 10 seconds or longer (e.g., ≥10s). In other applications, the number of phases ranges (for example) from 1 to 10 or more, or from 10 to 50 or more, or from 50 to 100 or more, and the total treatment cycle time can range from about a few seconds or less (≤1–10s) to several minutes or longer (≥1–10min).

[0101] Charge Balance

[0102] The random modulation function may be limited or controlled such that the absolute value of the integrated pulse height is the same in each successive phase 620 or 625 to achieve charge balance. For example, when delivering electrical stimulation such as microcurrent skin treatment, the integrated current or charge applied in each positive phase 620 can be limited to equal the absolute value of the integrated current or charge delivered in each negative phase 625, such that the net current and charge delivered to the skin are balanced.

[0103] In charge balance applications, the integrated power delivered in successive phases (620, 625) is substantially the same, and the net integrated charge and current are equal to or close to zero (i.e., within a selected limit or a minimum threshold range around zero). Alternatively, the modulation function may be unrestricted with respect to one or more parameters (e.g., pulse width, period, frequency, or amplitude), and the integrated charge or current may vary not only from pulse to pulse but also from phase to phase.

[0104] Other Modulated Waveforms

[0105] Figure 7A is an amplitude-time plot of a random pulse width modulation (RPW) waveform 700 having a substantially constant pulse period T0 and a carrier frequency f=1 / T0. The vertical axis represents pulse amplitude and the horizontal axis represents time, both scaled in arbitrary units.

[0106] As Figure 7A shown, waveform 700 is generated as a series of individual pulses 710 having a fixed or nominal amplitude A=A0, distributed over a plurality of phases (720, 725) of opposite polarity. Individual pulses 710 have variable ("on") pulse widths W=Wi, Wj, etc., separated by "off" pulse slices 715 of variable width, for which the amplitude is substantially zero or fixed at a selected bias voltage value. In this particular example, some pulses 710 have a width greater than the nominal width Wi>W0, corresponding to a positive pulse width deviation Δi (+) =+|Wi–W0|; other pulses have a relatively smaller width Wj<W0, corresponding to a negative deviation Δj (–)=–|W0–Wj|.

[0107] like Figure 7A As shown, individual deviations in periods Δi and Δj can also vary between different phases (720, 725). Therefore, each pulse width (Wi, Wj) can be different, making the modulated waveform 700 non-repetitive and non-periodic in each care phase (720, 725) or throughout the entire care cycle including any number of phases (720, 725). Alternatively, the values ​​of individual pulse widths (W = Wi, Wj) can be randomly ordered within each phase (720, 750), throughout the entire care cycle, or in other suitable non-repetitive or non-periodic manner.

[0108] Figure 7A The modulation function shown is constrained such that adjacent pulses 710 remain different in time; for example, positive deviations are constrained by |Δi| < |T – W0|, and negative deviations by |Δj| < |W0|. As mentioned above, the modulation function can also be constrained to maintain a selected average duty cycle on each care phase (720, 725) and to ensure charge, current, and power balance. More generally, any waveform 700 or other waveform described herein can be modulated to provide any number of positive pulses, negative pulses, or bipolar pulses on any number of consecutive phases, wherein each pulse can have a nominal, increasing, or decreasing pulse width (W = W0, Wi, Wj, etc.).

[0109] Figure 7B This is an amplitude-time diagram of waveform 750 with matched switching pulse width modulation. In this example, as shown on the vertical axis, the pulse amplitude is fixed at an arbitrary nominal value A = A0, and there are variable pulse widths (Wi, Wj) along the horizontal direction, also expressed in arbitrary units.

[0110] As shown in the figure, the pulses 710 that make up waveform 750 are distributed among multiple continuous phases (720, 725) and have positive or negative polarity. The “on” pulse width (W = Wi, Wj) of each pulse 710 matches the pulse width of the corresponding “off” pulse segment 715, and the pulse period T (“on” + “off”) changes accordingly (e.g., Ti = 2 × Wi, Tj = 2 × Wj, and so on).

[0111] In this specific example, since the widths of the "on" and "off" pulse slices are matched, the duty cycle of each pulse 710 is fixed at 50%, while the instantaneous frequency f varies with the total pulse period (f=1 / Ti, f=1 / Tj, etc.). The modulation function is constrained to achieve charge, current and power balance, and such that the total integrated pulse width and treatment time in each successive period (720, 725) are the same. More generally, any waveform 750 or other waveforms described herein can be modulated to have matched or unmatched "on" and "off" pulse widths, with fixed or variable pulse amplitude, pulse period and carrier frequency.

[0112] Figure 8A is an amplitude-time plot of a pulse frequency modulation (PFM) waveform 800 with random pulse period and frequency (RPF). In this example, the nominal amplitude of each pulse 810 is substantially constant (A=A0; vertical axis), and has a fixed "on" pulse width W0 (horizontal axis, expressed in arbitrary units). As reflected in the pulse period (T=Ti, Tj, etc.), the carrier frequency is modulated by changing the length of the "off" pulse slice 815, and the instantaneous (pulse-to-pulse) frequency varies accordingly (e.g., f=1 / Ti, F=1 / Tj, etc.).

[0113] As Figure 8A shows, a series of frequency-modulated pulses 810 can be arranged into consecutive phases (820, 825) with the same or alternating (e.g., positive and negative) polarities. The period of some pulses 810 is less than the nominal period Ti<T0, corresponding to a negative pulse period deviation δi (–) =–|T0–Ti|, and has a relatively high instantaneous (inter-pulse) frequency f>1 / T0. The period of other pulses 810 is greater than the nominal period Tj>T0, corresponding to a positive deviation Δj (+) =+|Tj–T0|, and has a relatively low instantaneous frequency f<1 / T0.

[0114] In Figure 8A the specific example, the nominal "on" pulse width W0 and amplitude A0 are substantially the same for each pulse 810 in the waveform 800. Therefore, as long as the number of pulses (N) is the same, charge, current and power balance between consecutive phases (820, 825) can be achieved without further restricting the modulation function. In addition, the modulation function can also be constrained to maintain the phase application time N×T0, such that consecutive phases (820, 825) are equally spaced in time. In other applications, the pulse width and amplitude of any waveform 800 or other waveforms described herein can also be modulated to provide different phase application times independent of the pulse period and carrier frequency or a combination thereof.

[0115] Figure 8Bis an amplitude-time diagram of a pulse amplitude modulation (PAM) waveform 850 with random pulse amplitude (RPA). As Figure 8B shown, the amplitude (A) of individual pulses 810 varies according to a random or pseudo-random function, while the nominal pulse width W0 remains substantially constant; for example, as shown, the "on" pulse width W0 may also be equal to the nominal width of the corresponding "off" pulse slice 815.

[0116] In Figure 8B the specific example, for each pulse 810 in the pulse amplitude modulated waveform 850, the nominal period T=T0 is substantially the same. Accordingly, the carrier frequency f=1 / T0 is also substantially constant. In other applications, the pulse period and carrier frequency may vary with the number of pulses and the individual pulse width.

[0117] As Figure 8B shown, the amplitude (A=Ai, Aj) of individual pulses 810 may vary relative to the nominal value A=A0. For example, some pulses have a relatively lower amplitude Ai<A0, corresponding to a negative amplitude deviation Di (–) = -|A0-Ai|. Other pulses have a relatively larger amplitude Aj>A0, corresponding to a positive deviation Dj (+) = +|Aj-A0|. Amplitude modulation may be applied to each phase in the same order in the same sequence, such that the amplitudes (Ai, Aj) of individual pulses 610 are the same in a first (e.g., positive) phase 820 and a second (e.g., negative) phase 825; alternatively, amplitude modulation may be applied in any order in any sequence, such that individual pulse amplitudes (Ai, Aj) vary in each phase (820, 825).

[0118] The random modulation function applied to the pulse amplitude modulation (PAM) waveform 850 may be constrained such that the integrated pulse amplitude is constant over each successive pulse sequence or treatment phase (820, 825) to achieve charge and current balance. Similarly, the modulation function may be constrained to deliver the same integrated power over successive phases (820, 825), and such that the net integrated charge and current is substantially zero (or close to zero within a selected minimum threshold as described above). Alternatively, the modulation function may be unconstrained, and the integrated amplitude of any waveform 850 or other waveforms described herein may vary with pulses, phases, and the applied voltage, current, and power.

[0119] Figure 9This is an amplitude-time diagram of waveform 900, which has a combination of random pulse width (RPW) modulation, random pulse amplitude (RPA) modulation, and random pulse frequency (RPF) modulation. In this particular example, the pulse width (W) and amplitude (A) vary between individual pulses 910 and the pulse period (T) and the corresponding instantaneous carrier frequency f = 1 / T. The number (N) of individual pulses can also vary with the distribution between consecutive (e.g., positive and negative polarity) phases (920, 925).

[0120] like Figure 9 As shown, a random modulation function is applied to waveform 900 to vary the widths (Wi, Wj) of individual pulses 910 relative to the nominal width W0. The modulation function can also be adapted to randomize the pulse amplitudes (Ai, Aj) (defined relative to the nominal value A0) and the instantaneous carrier frequency f = 1 / T (which varies with the individual pulse periods (Ti, Tj)). The width of the "off" pulse slice 915 can also vary with a width defined relative to the nominal "on" pulse width W0.

[0121] Individual modulation functions can be applied to randomize the parameters of each selected pulse, or combinations of modulation functions can be used. The modulation functions can also be adapted to maintain a fixed or constant pulse width, pulse amplitude, pulse period, or frequency on the sequence of individual pulses 610 constituting any one or more consecutive pulses 910 in the same order, or modulation can be applied in any sequence, combination, or order. Similarly, the number (N) of individual pulses in each sequence phase (920, 925) can be the same, or the number of pulses (N) can vary with the phase.

[0122] An appropriate random modulation function can be constrained to maintain a constant integral pulse amplitude in each consecutive phase (920, 925) to achieve charge, current, and power balance. Furthermore, the modulation function can be constrained to maintain a constant application time window N×T0 in each phase (920, 925) such that the consecutive phases are equidistant in time. Alternatively, the modulation function can be constrained without relation to the total pulse width or the integral pulse amplitude, or both, and the applied stimulus will vary accordingly.

[0123] Random pulse modulation function

[0124] Figure 10 This is a block diagram of a modulation function or method 1000 for random pulse width modulation, suitable for use with any waveform described herein. For example, the modulation function or method 1000 can be applied to modulate a waveform to use... Figure 3 The device 300 shown applies electrical stimulation for use in accordance with Figure 4 The method 400 shown is used for microcurrent-based skin care, or for... Figure 5 The method 500 shown performs pulse waveform modulation.

[0125] exist Figure 10 In a specific example, the modulation function or method 1000 includes: one or more start blocks or process steps 1100 with one or more initialization subfunctions or steps (1110, 1120, 1130, 1140); a sequence randomization process block or step 1200; an initial value process block or step 1300 with one or more shift, set, and count subfunctions or steps (1310, 1320, 1330); a pulse counting block or step 1400 with one or more output, system timer, delay, and polarity switching subfunctions or steps (1410, 1420, 1430, 1450); and a pulse increment process block or step 1500 with one or more sequence, delay, and count increment subfunctions or steps (1510, 1520, 1530). These functions, subfunctions, process blocks, and steps can be performed in any order or combination, with or without the additional functions and techniques described herein.

[0126] Function or method 1000 can be initialized in the startup operation or step 1100. The associated initialization steps (1110, 1120, 1130, 1140) can be executed as process steps or subfunctions to generate an initial pulse parameter vector or array PA representing a set of N pulses in a waveform or phase (initializing pulse array step 1110), and to generate an initial random (or other non-repeating) sequence vector or array RA representing a sequence in which pulses may occur (initializing random sequence step 1120).

[0127] The pulse parameter array PA represents the pulse width of an individual pulse in the waveform, or any combination of pulse parameters including pulse width, period, frequency, and amplitude. The pulse amplitude parameter can be randomized according to the sequence array RA, or the individual parameter values ​​can be randomized to make them aperiodic, or vary in some other random, pseudo-random, non-repetitive, aperiodic, or predefined manner. Some pulse parameters can also be fixed or substantially constant, for example, by varying the pulse width (or other pulse parameters) independently of other parameters.

[0128] To initialize the initial values ​​(step 1130), the initial value vector or array SA is set to zero (or other suitable initial value), for example, to reference a previous or pre-selected initial sequence, or a set of initial random waveform parameters. More generally, the initial value array SA can be used to track individual waveform modulation values ​​in the modulation parameter array PA, or a random array RA (or other random, pseudo-random, or predefined array) indicating the sequence in which varying pulse parameters are applied to modulate continuous pulses in the waveform.

[0129] To initialize the pulse polarity (step 1140), a pulse polarity indicator PP is generated or defined. For example, a bipolar polarity indicator PP can be defined to specify the positive or negative phase of the modulated pulse application, or a unipolar indicator PP can be defined to indicate one or more sequential unipolar phases.

[0130] In the sequence randomization block (randomization sequence step 1200), the array RA representing the waveform sequence is filled with a randomized set of different values ​​(step 1120), thereby indicating that the sequence of waveforms should be modulated by the pulse modulation parameter array PA. For example, the sequence can be randomized in a non-repeating manner using a set of pseudo-random integers, or a sequence corresponding to N pulses in a given phase can use another set of ordered, non-repeating, aperiodic variables. Alternatively, the pulse modulation parameter array PA can be generated or regenerated by random, pseudo-random, or other non-repeating or aperiodic components, and the sequence in which these parameters are applied can remain unchanged, or both the sequence and the parameters themselves can be randomized.

[0131] In the initial value check block (step 1300), the random sequence array RA or the pulse parameter array PA is compared with the corresponding initial value array SA. If the random sequence is the same as the initial value (or if the modulation parameters are the same), the sequence array RA can be shifted (shift sequence step 1310) to avoid repeating the same sequence. Depending on the application, the random sequence array RA can be cyclically shifted one or more positions in any direction, or otherwise reordered to change the sequence in which the pulse modulation parameter array PA is applied to continuous pulses. Alternatively, one or both of the modulation parameters (array PA) and the sequence (array RA) can be regenerated using a new set of random, pseudo-random, or other non-repeating or non-periodic values; for example, by returning the operation to the randomization sequence step 1200.

[0132] If the random sequence array RA is different from the initial value array SA (or after its shift or reordering), the initial value array SA is reset to the current random sequence array RA (setting initial value step 1320). Similarly, if the applied pulse modulation parameter array PA is different from the corresponding initial value (or after its rerandomization), the initial value array SA can be reset to the current parameter array PA.

[0133] Therefore, the initial value array SA can be used to track the latest sequence in which the modulation waveform parameter PA is applied, or to track the actual parameter values ​​themselves (or both). Once the initial value is updated (step 1320), the pulse count is reset to zero (step 1330), and it can be counted as continuous pulses are applied in the waveform.

[0134] When the pulse counting block is started (step 1400), the pulse count is checked. If the count has not yet reached the desired number of pulses (N) in the phase or waveform, the next pulse can be output according to steps 1410, 1420, and 1430. If the count has reached the number of pulses (N), the polarity indicator PP is switched (in the polarity switching + / - step 1450) before returning the operation to the sequence randomization block (step 1200). For example, the polarity indicator PP can be switched between positive and negative phases, or it can indicate that a new phase should be initialized in a unipolar application.

[0135] A waveform pulse is applied by setting the output to a high value and checking the system timer to determine an appropriate delay (step 1410). For example, a controller can be used to instruct a voltage or current source to apply a "high" or "on" signal to one or more electrodes according to the desired pulse amplitude. Furthermore, the controller can read or access the system clock or timer to maintain the output amplitude for a delay period according to the desired pulse width or pulse duration (delay pulse duration step 1420).

[0136] The pulse width (as well as pulse frequency, period, and amplitude) parameters used to modulate each continuous pulse are determined based on the pulse modulation parameter array PA, and applied sequentially to the continuous pulses according to the random sequence array RA. Once the pulse is output for the desired duration, the output is set to zero or other default "low" (or "off") value in the output low value step (block 1430).

[0137] The pulse count is checked again (step 1500), and if the count has reached N-1, the random sequence array RA can be refilled in the filling sequence block (step 1510) using pseudo-random integers or other ordered non-repeating values. Alternatively, the pulse parameter array PA can be reset using a new set of random, pseudo-random, or other non-repeating or non-periodic values ​​(see randomization sequence step 1200).

[0138] In the delayed pulse duration step (step 1520), the output is maintained at a low ("off") value for the desired duration based on the selected pulse width, period, or frequency parameters (delayed pulse duration step 1520). Alternatively, in an embodiment applying a bipolar pulse, the pulse polarity can be reversed.

[0139] Then, the count is incremented (count++ step 1530), and the process is returned to the check count block (step 1400). The function or method 1000 can then be iterated until the required number of pulses N are applied in each polarity phase and until the required number of care phases are applied, or until the process is manually stopped (e.g., by the user).

[0140] Representative device embodiments

[0141] Figure 11A and Figure 11B These are front and side external views, respectively, illustrating an embodiment of a representative skin care device 300 within a handheld housing 305. The housing 305 can be configured to encapsulate a power supply 310 with a voltage or current generator (or source) 320, a microprocessor controller 330, a memory 340, a user interface 350, and other internal components; for example, as described above. Figure 3 As stated above.

[0142] like Figure 11A and Figure 11B As shown in a specific embodiment, the elongated housing 305 may include a handle 306; for example, a textured gripping area 307 and a skin contact head 308 are formed at its upper end. The skin contact head 308 is shown having one, two, or more electrodes (155A, 155B) on its outer surface; for example, having a conductive surface that may have a patterned texture to generate electrical stimulation or other energy stimulation 150; for example, for delivering microcurrent stimulation to the skin of a subject. For example, suitable surface patterns are described in U.S. Design Patent Application No. 29 / 732,120, filed April 21, 2020, entitled “Microcurrent Skin Care Device,” the entire contents of which are incorporated herein by reference and used for all purposes.

[0143] In these specific embodiments, the outer electrode 155A is typically formed as an elliptical band that runs along the outer periphery of the contact head 308 and surrounds the elliptical inner electrode 155B. The center of electrode 155B is region 309, which may contain one or more skin sensors and other environmental sensors 158, for example, as described above.

[0144] biological effects

[0145] When modulated waveforms are applied as electrical (e.g., voltage or current) stimulation to a subject's skin, the use of programmed random pulse width modulation (PRPWM) can produce a variety of different biological effects. These applications differ from those using unmodulated or "non-random" (periodic or repetitive) waveforms, where the pulse width, pulse amplitude, and pulse period may not vary from pulse to pulse or between individual pulses within a given care phase.

[0146] The beneficial effects of microcurrent skin stimulation modulated with random pulse waveforms depend on the applied stimulation. Generally, due to the low levels of applied voltage, current, and charge, the microcurrent care disclosed herein is insufficient to significantly increase skin temperature through resistance heating, nor is it sufficient to directly induce electrochemical responses or neuromuscular stimulation. However, other effects may include both biological and electrochemical effects. Furthermore, these benefits are not limited to the skin tissue itself but may extend to include the subcutaneous layer. These effects may include, but are not limited to, changes in tissue resistivity, circulating blood flow, connective tissue and collagen properties, as well as changes in adenosine triphosphate (ATP) synthesis and amino acid uptake.

[0147] Furthermore, it is well known that electrical stimulation can alter selected properties of skin tissue, which in turn can be characterized by changes in resistivity. For these effects, microcurrent stimulation for a few minutes is sufficient to elicit the desired changes when applied within the voltage, current, and power range disclosed herein. Since the disclosed apparatus and methods can be applied in unipolar or bipolar modes, these effects can also respond to the net charge, current, or power applied in each care phase, as well as the total charge, current, and power applied over a complete care cycle.

[0148] For example, studies have confirmed that circulating blood responds more to microcurrent stimulation, including the use of electrolytes or other skincare products applied topically to the skin. This increased circulation, in turn, is associated with other beneficial biological effects, including improved capillary formation, healing, and nerve function.

[0149] Microcurrent skin care can also promote the formation and regeneration of collagen and other connective tissues in the epidermis, dermis, and subcutaneous tissue layers. Substantial results can also be seen after repeated treatment cycles (e.g., once or more daily) over several weeks or months. Studies have also shown that microcurrent therapy with alternating (opposite) positive and negative polarity phases, as disclosed in this article, can accelerate healing.

[0150] Microcurrent skin treatments have also been shown to increase ATP production and amino acid uptake in cells. As mentioned above, the associated increase in cellular metabolism and protein synthesis rates may be related to enhanced collagen formation, and these benefits may accumulate over treatment cycles of several weeks or longer, with total treatment cycles lasting two hours or more.

[0151] As mentioned above, the skin's response to electrical stimulation depends on the net charge or current delivered in each care phase, and the total charge or current delivered throughout the entire care cycle (including multiple consecutive phases with the same or opposite polarities). However, when subjected to more constant or more rigorous periodic stimulation, the homeostatic tendency may reduce the skin's response. Such stimulation may also lead to the development of corresponding periodic responses in tissues to maintain homeostasis in the skin tissue that the body perceives is being disrupted. Modulating the electrical pulses applied to the skin with random or pseudo-random components to make the pulses non-periodic, and modulating the random pulse width, amplitude, and period, can weaken the homeostatic tendency or the homeostatic maintenance tendency. These beneficial effects can also manifest as changes in resistivity, circulation, and ATP synthesis, which in turn may favor collagen formation and connective tissue properties.

[0152] The inventive systems and techniques disclosed herein can be modified in various ways and alternatively. Specific applications are described in detail through examples. However, the practice of the invention is not limited to these particular embodiments and implementations, and the scope of the invention includes any and all modifications, equivalents, and alternatives within the scope of the invention as defined in the appended claims. In these different embodiments, the invention includes any suitable combination of the elements described herein and those stated in the claims, and the claims may be practiced without any element specifically described herein.

[0153] Other energy stimuli

[0154] The general principle of applying electrical stimulation to the skin, as described above, can be extended to other forms of energy stimulation, not only in electrical form but also in other forms, where energy can be presented to the skin as a stimulus, allowing the energy to penetrate skin tissue and potentially produce biological effects. One example is the use of LEDs, low-power lasers, or other electromagnetic radiation emitters, commonly referred to as light, but also including or represented as radio frequency (RF), infrared (IR), or light energy from any suitable portion of the electromagnetic spectrum, or low-energy (near-UV) or other suitable ultraviolet (UV) light or other visible or invisible forms of light energy. Similarly, stimulation can be provided in the form of acoustic energy, for example, as subsonic, sound waves, or ultrasound stimulation. These different energy stimuli can be generated from an emitter that is controllable to produce modulated waveforms that have beneficial effects on the skin.

[0155] As described herein, such controllable waveforms can be modulated or controlled by randomizing or pseudo-randomizing one or more parameters of the waveform. If these modulation and controlled modulation and randomization techniques can be applied to electrical stimulation to project energy into the skin and produce beneficial effects, the same or similar techniques can be applied to other energy stimuli, including but not limited to electromagnetic and acoustic stimulation or any combination thereof. Therefore, the principles discussed herein can be applied in a similar manner by modulating continuous pulse groups in other energy waveforms, where the pulse widths of the continuous pulses vary in a random or pseudo-random manner.

[0156] These applications offer a variety of skin care options, where appropriate (e.g., low-level) energy stimulation is introduced to the skin by using the same or similar waveform modulation techniques to deliver energy stimulation from one or more transmitters, thereby producing beneficial effects on other or additional biological processes in the skin. For the reasons described above, these additional stimuli can also produce beneficial effects and can be applied to the skin to influence these and other biological processes.

[0157] For example, for LED lights or other light energy directed to the skin, the emitter's light or other electromagnetic energy output can be presented in pulse form, where the pulse width, period, frequency, or amplitude of continuous pulses varies in a random, pseudo-random, or other non-periodic manner. Therefore, the waveform control and modulation techniques described above are equally applicable to electrical, electromagnetic, and acoustic stimulation involving voltage, current, light, sound, and other forms of energy stimulation and combinations thereof, which can be generated, emitted, and transmitted in a relatively concentrated manner to, into, or through a selected limited area of ​​skin receiving treatment or other suitable area.

[0158] Experimental data

[0159] The following embodiments describe experiments designed and performed to provide information on the effectiveness and / or utility of the devices and methods described herein. In each embodiment described herein, reference to an ageLOC LumiSpa microcurrent accessory device with PRPWM refers to such a device disclosed herein, for example, a microcurrent device with PRPWM, a microcurrent accessory with PRPWM, or a PRPWM microcurrent device described herein.

[0160] All these embodiments have been selected using appropriate inclusion and exclusion criteria and are representative only. Other embodiments and implementations exist within the scope of this disclosure and the appended claims.

[0161] Example 1: A four-week clinical study combining microcurrent and PRPWM. The aim of this study was to observe and understand the tolerability, use, comfort, and beneficial skin appearance associated with the use of a microcurrent device with PRPWM and a conductive gel containing water (solution), glycerin, pentylene glycol, carbomer, sodium hydroxide, and chlorophenyl ether, and to compare it with a control group that applied the same conductive gel but did not use the microcurrent device.

[0162] The study employed a split-face design. The research center invited participants who met all inclusion criteria, did not meet any exclusion criteria, and had not used any anti-aging skincare products. Twenty participants completed the assessment. These participants were women with skin types ranging from Fitzpatrick I to III and ages from 25 to 40. A conductive gel containing the aforementioned ingredients, supplied by Nu Skin Enterprises, Inc., Prover, Utah, was applied to the entire face of each participant. Over a four-week period, the ageLOC LumiSpa microcurrent attachment device with PRPWM was used on a randomly selected side of the face. Instructions for use were as follows: Apply the gel to the entire face once daily. Use the device for one minute only on the randomly selected side of the face. Applying the gel to both sides of the face prevented the gel itself from becoming a differentiating factor.

[0163] Upon enrollment, subjects had conductive gel applied to their entire face, but the device was used on one randomly selected side of their face. Researchers and subjects assessed skin appearance and tolerance on both sides of the face to provide a baseline for comparison. A questionnaire was completed. Subjects received a compliance log and were informed of the device's usage. Subjects received instructions on how to use the device and used it for the first time at the research center under staff supervision.

[0164] Following the initial application, researchers and participants assessed the device efficacy and tolerability on each side of the face (receiving PRPWM treatment and not receiving PRPWM treatment). The following time points were defined: baseline, post-application, and weeks 1, 2, and 4.

[0165] Subjects were asked to return to the research center in weeks 1, 2, and 4. Assessments were completed at each time point: once based on clinical grading results and again based on the subject's self-perception. Efficacy assessments focused on multiple defined assessment points, including: tactile roughness, visual smoothness, overall firmness, eye area firmness, skin plumpness, texture, fine lines, wrinkles, crow's feet, smile lines, cheek wrinkles, pigmentation, skin tone, jawline contour, pores, radiance, and overall appearance.

[0166] These assessments used a 5-point scale: 0 = none; 1 = very mild; 2 = mild; 3 = moderate; 4 = severe. Tolerance assessments included irritation, stinging, burning, itching, peeling, and dryness. These assessments used a 5-point scale: 0 = none; 1 = very mild; 2 = mild; 3 = moderate; 4 = severe. Subjects' compliance logs were checked at the assessment time points.

[0167] Figure 12A and Figure 12B The percentage change in user-perceived results relative to baseline for the first set of skin care criteria (tactile roughness, visual smoothness, overall firmness, eye area firmness, skin plumpness, and texture) is shown. As described herein, skin effects of receiving only the care gel are shown at time points immediately after application and at weeks 1, 2, and 4. Figure 12A ) and the skin effects of receiving gel and PRPWM microcurrent device treatment ( Figure 12B ).

[0168] Figure 12C and Figure 12D The figures show the percentage change relative to baseline for the clinical grading results of the first set of criteria at each corresponding time point. The two figures also illustrate the skin effects of receiving only the treatment gel. Figure 12C ) and the effects on skin treated with gel and PRPWM device ( Figure 12D ).

[0169] exist Figures 12A to 12D In the diagram, each group of four adjacent bars represents the change in one criterion from the baseline at the time points of application and at weeks 1, 2, and 4 (bars arranged from left to right) within the first group of criteria. The percentage above the bar indicates a statistically significant change relative to the baseline, determined based on the corresponding care criterion and time point represented by that bar. Results for some criteria may indicate a more significant effect based on user self-assessment at a given time point; while results for others may indicate a more significant effect based on clinical grading results. Some results may also indicate that no significant change was observed based on self-assessment or clinical grading results, rather than no observation at all.

[0170] Figure 13A and Figure 13B The percentage change in user self-perceived results relative to baseline for the second set of skin care criteria (fine lines, wrinkles, crow's feet, smile lines, and cheek wrinkles) is shown. As described herein, skin effects of receiving only the treatment gel are shown at time points immediately after application and at weeks 1, 2, and 4. Figure 13A ) and the skin effects of receiving gel and PRPWM microcurrent device treatment ( Figure 13B ).

[0171] Figure 13C and Figure 13D The figures show the percentage change in clinical grading results relative to baseline for the second set of criteria at each corresponding time point. The two figures also illustrate the skin effects of receiving only the gel. Figure 13C ) and the effects on skin treated with gel and PRPWM device ( Figure 13D ).

[0172] exist Figures 13A to 13D In the diagram, each group of four adjacent bars represents the change in one criterion of the second group of standards relative to the baseline at consecutive time points. In one embodiment, data from an additional time point at week 8 are also shown. Percentages indicate statistically significant changes relative to the baseline, determined based on the relevant standard of care and time point. Some results may indicate that no significant changes were observed for self-assessment or clinical grading results, rather than no observations were made.

[0173] Figure 14A and Figure 14B The percentage change in user self-perceived results relative to baseline for the third set of skin care criteria (pigmentation, skin tone, jawline contour, pores, radiance, and overall appearance) is shown. As described herein, skin effects of receiving only the care gel are shown at time points immediately after application and at weeks 1, 2, and 4. Figure 14A ) and the skin effects of receiving gel and PRPWM device treatment ( Figure 14B ).

[0174] Figure 14C and Figure 14D The figures show the percentage change relative to baseline in clinical grading results for the third set of criteria (pigmentation, skin tone, jawline contour, pores, radiance, and overall appearance) at each time point after application, at week 1, week 2, and week 4. The two figures also show the skin effects of receiving only the gel. Figure 14C ) and the effects on skin treated with gel and PRPWM device ( Figure 14D ).

[0175] exist Figures 14A to 14D In the table, each group of four adjacent bars represents the change in one of the criteria in the third group relative to the baseline at consecutive time points. Percentage changes indicate statistically significant changes relative to the baseline, determined based on the relevant care criteria and time points. Depending on the user's self-assessment or clinical grading results, some criteria may show significant or relatively insignificant effects, while other results may indicate no significant change (rather than no observation).

[0176] Efficacy evaluation by researchers. (Blinded) Researchers evaluated the treated side of the face and the untreated side of the face separately. Differences were considered useful in baseline analysis. After one application, both sides of the face typically showed a reduction in roughness. Figures 12A to 12D This immediate effect may be due to the microcurrent gel, microcurrent treatment, or both applied to both sides of the face. During the 4-week study, the roughness of both sides of the face continued to improve.

[0177] In week 1, at least for the first set of standards and the second set of standards (e.g., such as...) Figures 12A to 12D , Figures 13A to 13D as well as Figures 14A to 14D (As shown in bold and / or baseline), no statistically significant differences were observed between the treated and untreated sides of the face. By week 2, the treated side showed statistically significant improvements in overall firmness (p = 0.004), eye area firmness (p = 0.001), and overall facial appearance (p = 0.031) compared to the untreated side (based on both the first and third criteria). Figures 12A to 12D as well as Figures 14A to 14D These improvements persisted into week 4, with statistically significant improvements observed in roughness (p = 0.039), smoothness (p = 0.019), facial firmness (p < 0.001), eye area firmness (p < 0.001), skin plumpness (p = 0.024), texture (p = 0.013), and overall facial appearance (p = 0.001). Considering the younger age of the sponsor-designated participant group, participants noticed significant improvements in skin firmness and visual and tactile properties of the skin after 4 weeks of device use.

[0178] Efficacy assessment of subjects. Generally, (non-blinded) subjects did not immediately notice any statistically significant changes after one use of the device. During week 1, subjects noted statistically significant improvements in pore size (p = 0.046) and radiance (p = 0.036) on the treated side of the face (third-group criteria). Figures 14A to 14D By week 2, participant assessments showed a statistically significant improvement in eye tightness (p = 0.006) (first-group standard). Figures 12A to 12D By week 4, other additional assessments showed statistically significant improvements, including smoothness (p = 0.014), eye area firmness (p = 0.037), and pore size (p = 0.008) (based on both Group 1 and Group 3 criteria). Figures 12A to 12D as well as Figures 14A to 14D ).

[0179] The efficacy endpoints are shown below:

[0180] Primary efficacy endpoint: The primary efficacy endpoint refers to the ability of the microcurrent device, as evaluated by researchers, to provide skin benefits compared to the control group. The primary endpoint has been met.

[0181] Secondary efficacy endpoint: The secondary efficacy endpoint refers to the ability of the microcurrent device to provide skin benefits as assessed by subjects compared to the control group. The secondary endpoint has been met.

[0182] Tolerability. No serious adverse events, adverse events, or adverse experiences occurred in subjects or researchers during the study. The safety endpoint was the absence of significant adverse reactions. All subjects met the safety endpoint. According to researcher or subject assessments, use of the device did not cause any skin problems.

[0183] Example 2: Circulation / Blood Flow Procedure in Female Subjects. This was a 1-day clinical study conducted in healthy female volunteers to compare the effects of using a microcurrent device with PRPWM versus conductive gel and investigating topical medications on circulation / blood flow (relative to baseline). The device used was the ageLOC LumiSpa microcurrent accessory with PRPWM. The topical products used are as follows: Nu Skin conductive gel (ingredients as described in Example 1 above); research formulation, named MC Boost "East" (ingredients: water, glycerin, butylene glycol, dimethicone, niacinamide, tetrahexyldecanoic acid, polyglycerol-6-distearate, jojoba ester, polyglycerol-6-polyricinoleate, phenoxyethanol, watermelon fruit extract, sodium acrylate copolymer, chlorphenesin, sodium PCA, lentil seed extract, beeswax, cetyl alcohol, acrylic acid / C10-30 alkanol acrylate crosspolymer, xanthan gum, apple extract, lecithin, ethylhexylglycerin, tetrasodium diacetate, sodium lactate, aminomethylpropanol, hydroxypropyl methylcellulose stearyl ether, propylene glycol, acetylated sodium hyaluronate, sodium hyaluronate, potassium sorbate, sodium benzoate, sea hyaluronic acid extract, sodium hydroxide).

[0184] This study was a single-blind, facetized, randomized clinical trial with 25 participants, all healthy female volunteers aged 25 to 40 years with Fitzpatrick skin types I-III. The following test samples were provided by the sponsor:

[0185] 1. Device: ageLOC LumiSpa microcurrent accessory with PRPWM—specifically for clinical research use;

[0186] 2. Topical medications: Nu Skin conductive gel; and

[0187] 3. Topical medication: MMC Boost "East".

[0188] The care procedure for topical conductive gel is as follows:

[0189] 1. Researchers used gloved fingers / hands to apply a coin-sized amount of product to a defined circular area approximately 2 inches (about 5.08 cm) in diameter on one side of the subject's face (randomized based on the application of the topical medication).

[0190] 2. Researchers spent less than 10 seconds applying the product to their cheeks.

[0191] 3. After applying the product, the researchers immediately turned on the age LOC LumiSpa microcurrent attachment device with PRPWM and applied it to the subject's cheek area for 20 seconds, ensuring that it remained within the circle drawn for the purpose of applying the product.

[0192] 4. No more than 2 minutes after using PRPWM care, measure the laser Doppler reading and temperature reading at the center of a 2-inch (5.08 cm) diameter circle.

[0193] Treatment procedure for topical MC Boost “East”: Researchers repeated steps 1 through 4 above on other cheek areas of the subjects.

[0194] On day 1 of the study (baseline), participants arrived at the testing facility with clean faces and no makeup. Prior to the study, participants provided written informed consent and underwent screening to determine their eligibility. Researchers inquired about participants' medical history and any medications they were taking. Participants underwent facial skin condition assessments and demographic information collection.

[0195] Before undergoing instrumental assessment, subjects acclimatized to room temperature for at least 30 minutes. Prior to the instrumental assessment, a researcher or designated person drew a circle approximately 2 inches (about 5.08 cm) in diameter on both sides of the subject's face. Inside the testing facility, both sides of the subject's face underwent baseline temperature readings and laser Doppler instrumental assessment. The researcher or designated person applied the testing product to the subject and used a PRPWM device (see the care procedure above). The side of the face receiving the conductive gel treatment was randomly assigned to either the right or left side. After both sides of the face had been treated, the subject underwent the same instrumental assessment on both sides of the face.

[0196] Instrumental and visual assessments include:

[0197] Laser Doppler Flowmeter – Measures skin blood flow (mean flux, in arbitrary units) using a laser Doppler imager (Moor LD12-IR). The LDI2-IR system uses a 785nm near-IR laser (maximum power 2.5mW) for measurement. Maximum penetration depth is between 2mm and 3mm into the skin. The measurement site is approximately 1 inch (approximately 2.54 cm) in diameter, centered on a treatment area approximately 2 inches (approximately 5.08 cm) in diameter. Subjects are instructed to remain as still as possible while the laser Doppler readings are taken. Subjects' eyes are covered to prevent exposure of their eye area to the laser. Measurements are taken on both sides of the subject's face at baseline (before treatment) and after treatment.

[0198] Temperature assessment – ​​After baseline and treatment, temperature is assessed on a 2-inch (5.08 cm) diameter area of ​​skin surface on both cheeks using a non-contact infrared device (Equinox International EQ-THERM03).

[0199] Visual assessment – ​​to evaluate the overall skin condition of the subjects to ensure they meet the study eligibility criteria.

[0200] Statistical analysis. Data were obtained from laser Doppler and temperature assessments at each time interval (baseline, 2 minutes after treatment). Changes relative to the baseline were analyzed during the treatment process using t-tests. Changes relative to the baseline were analyzed between treatments using ANOVA with the baseline as a covariate vector. All statistical tests for this hypothesis were two-sided tests at a significance level of 0.05, and the number of tests was not adjusted.

[0201] Figure 15A and Figure 15B These are a table and a bar chart summarizing the laser Doppler assessment data. Figure 15B The bar chart shown contains three pairs of bars. The left bar in each pair shows the data for the conductive gel (Example 1), and the right bar in each pair shows the data for the MC Boost “East” gel (as described above).

[0202] Figure 16A and Figure 16B These are a table and a bar chart summarizing the temperature assessment data. Similarly, the left bar in each pair shows the data for the conductive gel (Example 1), while the orange or right bar in each pair shows the data for the MC Boost “East” gel (as described above).

[0203] Study Conclusions: Room-of-care and in-care analyses were conducted to examine changes in mean flux (blood flow) and facial temperature relative to baseline. In-care analysis revealed statistically significant decreases in mean flux and temperature at both care sites relative to baseline. No statistically significant differences were found between care sites regarding mean flux or temperature. While not theoretically constrained, these decreases are believed to be caused by vasoconstriction, but the mechanisms of vasoconstriction under experimental conditions are not fully understood.

[0204] Example 3: Tolerance Study in Male Subjects. A crucial aspect of facial microcurrent treatments is tolerability. Microcurrent treatments that are very uncomfortable or painful, or even cause mild discomfort, are generally unacceptable to some. To investigate the tolerability of microcurrent attachments with PRPWM, this study focused on shaving in male subjects.

[0205] It is well known that freshly shaved skin is typically more sensitive than other areas of skin. Six male participants aged 25 to 40 completed a comparative evaluation using the Nu Skin ageLOC Galvanic Spa and a microcurrent attachment with PRPWM. The former delivers a low-level direct current to the skin. While conductivity and sensitivity vary from person to person and depending on any moisturizer or other materials applied, the Nu Skin ageLOC Galvanic Spa typically delivers 2.5 times less current than is required to produce only a slight sensation.

[0206] In the tolerability study, participants shaved using their own shaving cream / gel / topical product and razor, and received a microcurrent attachment with PRPWM and a Nu Skin ageLOC Galvanic Spa. Immediately after shaving, participants used the ageLOC Galvanic Spa at setting 1 on one side of their face (cheek). A clinical observational researcher recorded the time the subject could comfortably tolerate the device. Then, participants used the ageLOC Galvanic Spa at setting 2 on the same side of their face (cheek). The clinical observational researcher again recorded the time the subject could comfortably tolerate the device. After using the ageLOC Galvanic Spa at settings 1 and 2, participants used the ageLOC LumiSpa microcurrent attachment with PRPWM on the other side of their face. The clinical observational researcher again recorded the time the subject could comfortably tolerate the device.

[0207] Figure 17 This is a table summarizing the tolerance data of male subjects in Example 3. Figure 17The table shown illustrates the observations of clinical researchers on the three different current care methods described above. It should be noted that when the ageLOC Galvanic Spa is set to level 1, a positively polarized microcurrent is present, which can be automatically set to 0.125mA, 0.250mA, or 0.350mA (±10%). The setting is based on the capacitance of the skin at the point of contact, the prevailing environmental conditions, and the physiological condition of the subject's skin at the time of use.

[0208] When the ageLOC Galvanic Spa is set to level 2, a negative microcurrent is present, which can be automatically adjusted to the same level as level 1. Level 1 lasts for 2 minutes, and level 2 lasts for 3 minutes, but the user can remove the device from the skin at any time. Some users have shortened the treatment time, as shown in the table.

[0209] The results in Example 3 showed that the ageLOC LumiSpa microcurrent attachment with PRPWM was more tolerable compared to treatments using the ageLOC Galvanic Spa at both settings (level 1 and level 2); that is, the latter was considered gentler on freshly shaved skin. Specifically, the PRPWM microcurrent treatment was tolerable for 30-second treatment cycles without causing any discomfort, while for subjects using level 1, the ageLOC Galvanic Spa at level 1 was only tolerable for 1 to 3 seconds. For the ageLOC Galvanic Spa at level 2, one subject tolerated up to 25 seconds, while the others tolerated 1 to 6 seconds.

[0210] Representative applications, examples, and implementation schemes

[0211] Representative device applications, embodiments, and implementations include: one or more transmitters configured to apply stimulation to the skin surface of a subject; a voltage source or current source; and a computer-based controller. The voltage source or current source may be adapted to generate a waveform for applying the stimulation to the skin surface of the subject via the one or more transmitters. The controller may be configured with memory and processor hardware for modulating continuous pulse groups in the waveform.

[0212] In any of these applications, embodiments, and implementations, the continuous pulse group may define a care cycle having one or more phases, for example, each phase defining a continuous subset of the continuous pulses. The pulse width or absolute integral amplitude (or other amplitude) of the continuous pulses in each phase may alternatively or in combination vary over at least one continuous subset defining at least one phase, over each subset defining each phase, or over the continuous pulse group defining the care cycle. For example, the pulse width or the absolute integral amplitude may be non-repetitive or non-periodic over one or more phases of the care cycle or over each phase of the care cycle; or, the pulse width or the absolute integral amplitude may otherwise vary over one or more phases of the care cycle or over each phase of the care cycle.

[0213] In any of these applications, embodiments, and implementations, the pulse width or absolute integral amplitude (or other amplitude) of the continuous pulses can vary in a predefined, random, or pseudo-random sequence, such that the pulse width or absolute integral amplitude is, alternatively or in any combination, non-repetitive in one or more of the phases, in each of the phases, or on the continuous pulse group defining the care cycle. The predefined, random, or pseudo-random sequence can also be shifted or reordered between phases or otherwise restricted to provide the same duty cycle on each phase, and / or to provide charge balance on two or more phases of continuous pulses with opposite polarities. The sequence can be shifted or reordered between phases such that the pulse width or absolute integral amplitude varies in different sequences in two or more of the phases.

[0214] In any of these applications, embodiments, and implementations, the pulse width and the absolute integral amplitude (or other amplitude) of the continuous pulse can be determined at least in part based on a random or pseudo-random number generator. The pulse width and the absolute integral amplitude of the continuous pulse may also include or contain random, predetermined, or pseudo-random components, such that the absolute integral amplitude of the continuous pulse has the same absolute value over each subset of the continuous pulse (defining two or more phases) or over each phase.

[0215] In any of these applications, embodiments, and implementations, the pulse width, period, frequency, or absolute integral amplitude (or other amplitude) of the continuous pulses can be varied in any combination. The variation can be aperiodic or non-repetitive, such that the modulation parameters do not repeat at all on a given set of pulses defining a care cycle and / or on a continuous subset of pulses defining a phase of the care cycle, or do not repeat in any identifiable pattern or sequence.

[0216] In any of these applications, embodiments, and implementations, the variation of the modulation pulse parameter may be at least 1% or at least 10% or less of the nominal value or average value of the parameter, wherein the nominal value or average value is determined in a subset of consecutive pulses defining a phase of a selected care cycle or in a group of consecutive pulses defining the care cycle. The variation of the modulation pulse parameter may also be at least 20% of the nominal value or average value, for example, up to 50%, up to 100%, or up to twice the nominal value or average value, using any order or combination of lower limits of at least 1% or at least 10% of the nominal value or average value of the parameter. The variation of the modulation pulse parameter may also be extended to ten times or one hundred times or more of the nominal value or average value, using any other order or combination of limits.

[0217] In any of these applications, embodiments, and implementations, the one or more phases may include: a first phase (or one or more first phases), a first continuous subset of the continuous pulses having a first polarity; and a second phase (or one or more second phases), a second continuous subset of the continuous pulses having a second polarity opposite to the first polarity. The absolute integral amplitude (or other amplitude) of the continuous pulses may vary such that the amplitude is wholly or partially non-repetitive and / or non-periodic within the continuous pulse subset defining each phase, or wholly or partially non-repetitive and / or non-periodic within the continuous pulse group defining the care cycle.

[0218] In any of these applications, embodiments, and implementations, the subset of continuous pulses in each phase may have a constant absolute integral amplitude or other constant amplitude. The period of the subset of continuous pulses may be fixed such that the frequency of the continuous pulses is constant over one or more of the phases, over each of the phases in the care cycle, or over the set of continuous pulses defining the care cycle.

[0219] In any of these applications, embodiments, and implementations, the frequency of the subset of continuous pulses in each phase can be varied such that the period of the continuous pulses is non-repetitive or non-periodic over one or more of the phases, over each of the phases in the care cycle, or over the set of continuous pulses defining the care cycle.

[0220] In any of these applications, embodiments, and implementations, each of the continuous pulses may include a first slice having a first absolute integral amplitude (or other amplitude) and a second slice, for example, a second amplitude or no amplitude, wherein the first slice and the second slice have the same width. Each of the continuous pulses may include a first slice and a second slice with different widths.

[0221] In any of these applications, embodiments, and implementations, the one or more transmitters may include at least one electrode disposed near the skin surface. The waveform may include an electrical waveform emitted through the at least one electrode and adapted to apply the stimulation to the skin surface as microcurrent care. The modulated waveform may be adapted to apply the microcurrent care directly to the skin surface or through a conductive fluid disposed on or between the skin surface and the at least one electrode. A sensor may be configured to generate feedback in response to the stimulation propagating to or through the subject's skin surface (e.g., using a sensor circuit coupled to one of the transmitters or using a separate sensor device), wherein the waveform is modulated based on the feedback to apply the microcurrent care to the skin surface through a fluid disposed on or between the skin surface and the at least one electrode.

[0222] Representative method applications, embodiments, and implementations include modulating a waveform for applying stimulation to the skin surface of a subject. Suitable methods may include: providing a device near the skin surface of the subject; supplying a voltage or current adapted to generate a waveform for applying the stimulation to the skin surface; and modulating a continuous group of pulses in the waveform; for example, using one or more transmitters configured to apply the stimulation to the skin surface.

[0223] In any of these applications, embodiments, and implementations, the continuous pulse set may define a care cycle having one or more phases, for example, each phase defining a continuous subset of the continuous pulses. The pulse width or absolute integral amplitude of the continuous pulses may vary over at least one continuous subset defining at least one phase or over the continuous pulse set defining the care cycle (e.g., over each of the subsets defining each phase). For example, the pulse width or the absolute integral amplitude may be non-repetitive or non-periodic over one or more phases, over one or more continuous subsets defining each phase, or over the entire set of continuous pulses defining the care cycle.

[0224] In any of these applications, embodiments, and implementations, the pulse width or absolute integral amplitude (or other amplitude) of the continuous pulses can vary in a predefined, random, or pseudo-random sequence such that the pulse width or amplitude is non-repetitive or aperiodic on one or more of the phases, on each of the phases, or on the continuous pulse set defining the care cycle. The sequence can be shifted or reordered between phases such that the pulse width or absolute integral amplitude (or other amplitude) varies differently in a subset of continuous pulses defining two or more of the phases; for example, varying in different sequences in two or more phases. All or in combination, the sequence can be restricted to provide the same duty cycle on each phase or on two or more phases, and / or to provide charge balance on two or more phases of continuous pulses with opposite polarities.

[0225] In any of these applications, embodiments, and implementations, the absolute integral amplitude (or other amplitude) of the subset of continuous pulses in each phase can be varied such that the amplitude is entirely or in any combination of the following: in one or more phases, in each phase, in the subset of continuous pulses defining each phase, or in the group of continuous pulses defining the care cycle. The frequency of the subset of continuous pulses in each phase can be varied such that the period of the continuous pulses is entirely or in combination of the following: in each phase or in the group of continuous pulses defining the care cycle.

[0226] A non-transitory machine-readable data storage medium may be provided, on which program code is stored. The program code may be executed by a microprocessor or other computing device to operate a device or perform a method according to any of these applications, embodiments, and implementations.

[0227] Representative skin care system applications, embodiments, and implementation schemes may further include: one or more transmitters configured to emit stimulation for application to the skin surface of a subject; a voltage or current source configured to generate a waveform for applying the stimulation to the skin surface via the one or more transmitters; and a controller configured to modulate a continuous pulse group in the waveform. The continuous pulse group may define a care cycle having one or more phases, for example, each phase defining a continuous subset of the continuous pulses; the continuous pulses may vary with pulse width, period, frequency, or amplitude, for example, by varying them randomly, pseudo-randomly, or in a pre-selected sequence, such that the continuous pulses are entirely or in combination non-repetitive or non-periodic on the continuous pulse subset defining one or more phases, on each phase, or on the continuous pulse group defining the care cycle.

[0228] In any of these applications, embodiments, and implementations, the one or more transmitters may include: one or more electrodes configured to emit the stimulation applied to the skin surface as an energy voltage or current stimulus. The one or more transmitters may include: one or more transducers configured to generate the stimulation applied to the skin surface as an energy subsonic, sound wave, ultrasound, or acoustic stimulus. The one or more transmitters may include: one or more LEDs, lasers, or other electromagnetic sources configured to generate the stimulation as an energy radio frequency (RF), infrared (IR), near-ultraviolet (near-UV), or ultraviolet (UV) stimulus. The one or more transmitters may include any combination of the electrodes, transducers, LEDs, lasers, or other electromagnetic sources.

[0229] In any of these applications, embodiments, and implementations, the continuous pulses can be a predefined, random, or pseudo-random sequence variation such that the continuous pulses are non-repetitive or non-periodic on at least one of the phases, on each of the phases, or on the group of continuous pulses defining the care cycle. The sequence can be restricted to provide the same duty cycle on each phase, or to provide charge balance on two or more of the phases of continuous pulses with opposite polarities. The sequence can be shifted or reordered (e.g., between phases) such that the subset of continuous pulses provides the same duty cycle on each phase, or to provide charge balance on two or more of the phases of continuous pulses with opposite polarities.

[0230] In any of these applications, embodiments, and implementations, the waveform may be further modulated based on feedback that responds to stimulation from the one or more transmitters, for example via a topical agent applied between the transmitter and the skin surface, or by using a fluid (e.g., a conductive fluid) disposed between the transmitter and the skin surface, or in the absence of such a topical agent or fluid, to propagate into or through the subject's skin surface.

[0231] A non-transitory machine-readable data storage medium may be provided, on which program code is stored; for example, wherein the program code is executable by a microprocessor to operate a portable computing device, such as a smartphone, tablet, personal computer, or other user computing device. The portable computing device may be configured to communicate with a device according to any one of these applications, embodiments, and implementations; for example, the one or more transmitters are configured to emit the stimulus, the voltage or current source is configured to generate the waveform, the controller is configured to modulate the continuous pulse group in the waveform, or the continuous pulses are varied by operating the portable computing device with pulse width, period, frequency, or amplitude.

[0232] In any of these applications, embodiments, and implementations, the device may include an interface (e.g., a wired or wireless interface) configured to communicate with a portable computing device having a non-transitory machine-readable data storage medium thereon storing program code executable by a microprocessor to operate the portable computing device in communication with the skin care device, wherein the stimulus can be selected by operating the portable computing device, or the portable computing device can be configured to select the stimulus. Suitable portable computing devices include, but are not limited to, mobile phones, tablets, smartphones, smartwatches, personal computers, and other personal computing devices.

[0233] Combination, modification, and equivalent forms

[0234] This disclosure relates to representative embodiments and implementations. Each exemplary embodiment of the invention disclosed herein can be used alone or in combination with any other embodiment or implementation described or illustrated herein, and each exemplary embodiment can be combined with additional modifications, variations, equivalents, and alternatives within the scope of this disclosure, as read and understood by one of ordinary skill in the art, without departing from the practice of the invention as set forth in the appended claims. These different embodiments and implementations are provided illustratively and should not be construed as limiting the scope of the invention, nor should they be construed as limiting the scope defined by the common language of the claims.

Claims

1. A device (300) for microcurrent care, the device comprising: One or more transmitters (155) are configured to apply stimulation (150) to the skin surface of a subject; A voltage or current source (310) is adapted to generate a waveform for applying stimulation (150) to the skin surface of the subject via the one or more transmitters (155); as well as A controller (330) is configured to modulate a continuous pulse group in the waveform, wherein the continuous pulse group defines a nursing cycle having one or more phases, each phase defining a continuous subset of the continuous pulses; The pulse width or absolute integral amplitude of the continuous pulse varies over at least one continuous subset defining at least one phase or over the group of continuous pulses defining the nursing cycle. The feature is that the one or more transmitters (155) include at least one electrode disposed adjacent to the skin surface, and the waveform includes an electrical waveform emitted through the at least one electrode and adapted to apply the stimulation to the skin surface as microcurrent care; The pulse width or absolute integral amplitude of the continuous pulse varies in a predefined, random, or pseudo-random sequence, such that the pulse width or absolute integral amplitude is non-repetitive or non-periodic on one or more of the phases or on the continuous pulse set defining the care cycle. The sequence is restricted to providing the same working cycle on each phase or on two or more of the phases, or to providing charge balance on two or more of the phases with consecutive pulses of opposite polarity.

2. The apparatus of claim 1, wherein the pulse width and the absolute integral amplitude of the continuous pulse are determined at least in part based on a random or pseudo-random number generator, or the pulse width and the absolute integral amplitude of the continuous pulse include random, predetermined, or pseudo-random components such that the absolute integral amplitude of the continuous pulse has the same absolute value determined on each subset of the continuous pulses in two or more of the phases.

3. The apparatus of claim 1, wherein the one or more phases comprise: A first phase, the first phase having a first continuous subset of the continuous pulses having a first polarity; And a second phase having a second continuous subset of the continuous pulses having a second polarity opposite to the first polarity.

4. The apparatus of claim 1, wherein the continuous pulse subset in one or more of the phases has a constant absolute integral amplitude, or wherein the period of the continuous pulse subset is fixed such that the frequency of the continuous pulse is constant over one or more of the phases.

5. The apparatus of claim 1, wherein each of the continuous pulses includes a first segment having a first amplitude, and further includes a second segment having a second amplitude or having no amplitude, the first segment and the second segment having different widths.

6. The apparatus of claim 1, further comprising a sensor (158) configured to generate feedback in response to the stimulus propagating to or through the skin surface of the subject, wherein the waveform is modulated based on the feedback to apply the microcurrent care to the skin surface via fluid disposed on or between the skin surface and the at least one electrode.

7. The apparatus of claim 1, wherein the sequence is shifted or reordered between phases such that the pulse width or the absolute integral amplitude varies in different sequences in two or more of the phases.

8. The apparatus of claim 1, wherein the absolute integral amplitude of the subset of continuous pulses in each phase varies such that the absolute integral amplitude is non-periodic or non-repetitive over one or more of the phases or over the set of continuous pulses defining the care cycle.

9. The apparatus of claim 1, wherein the frequency variation of the subset of continuous pulses in each phase is such that the period of the continuous pulses is non-repetitive or non-periodic on each phase or on the set of continuous pulses defining the care period.

10. A non-transitory machine-readable data storage medium having program code stored thereon, the program code being executable by a microprocessor to operate the device according to claim 1.

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