The application relates to skin treatment. More generally, the application relates to skin treatment systems, devices, and methods with a thermally modulated treatment head. Suitable applications include, but are not limited to, microcurrent devices for cosmetic skin care and skin treatment, skin treatment systems with a thermally modulated head adapted for heating a topical agent, and combinations thereof.
The skin is the largest organ of the human body, forming a physical barrier to the environment and providing important functions including insulation, temperature regulation and protection against microorganisms, as well as touch, heat sensitivity, and other forms of sensation. The skin also regulates the passage of water and electrolytes, and produces vitamin D.
The outermost skin layer or epidermis covers the body's surface. Most of the 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 sensitivity to touch, and Langerhans cells, a type of white blood cell or macrophage that is part of the immune system, acting to protect the body against infection.
The epidermis surrounds the dermis. The structure of the dermis is provided by fibroblasts, which synthesize collagen and elastin proteins to form the extracellular matrix, with collagen fibers to provide strength and toughness, and elastin threads or filaments to provide elasticity and flexibility. The fibroblasts also produce proteoglycans, viscous proteins that provide hydration and lubrication, and regulate ionic binding and molecular transport. The dermis also includes macrophages and mast cells, part of the immune system, as well as the hair follicles, sweat and oil glands, nerve cells, and blood vessels.
The epidermis and dermis make up the cutis. Subcutaneous tissue connects the cutis to the underlying muscle and fascia, and to other connective tissue including the periosteum (covering the bones). The subcutis also includes elastin and adipose (fat) cells.
Skin firmness and elasticity are often associated with the production of Type I collagen (typically the more abundant form), as well as elastin, proteoglycans, and other components of what is known as the extracellular matrix. A healthy extracellular matrix can also improve skin resilience and coloration, and promote immune response.
A range of personal skin care products have been provided to help enhance these effects, including topical products and hand-held devices for cleansing, exfoliating and smoothing the outer skin layers. In galvanic systems, one or more anode or cathode electrodes are typically arranged to produce an electric potential across the skin, providing current flow through the epidermal and dermal layers. Advanced microcurrent based devices can include a control circuit operably connected to the electrodes, in order to carefully regulate the current to promote ion transport and other biological effects; e.g., as described in for example as described in U.S. Pat. No. 10,046,160 B 1, U.S. Pat. No. 10,080,428 B2, U.S. Pat. No. 10,661,072 B2, and U.S. Pat. No. 10,772,473 B2, each of which is assigned to NSE (Nu Skin Enterprises) Products, Inc., of Provo Utah, and incorporated by reference herein.
More generally, skin response to electric current flow involves a number of complex and interacting biological processes, and the full range of different effects have not all been recognized in the prior art. There is an ongoing need more advanced approaches to skin care, including skin treatment techniques developed with a better understanding of the underlying biological response mechanisms of the skin, and how these mechanisms interact with different topical treatments and delivery techniques.
A skin treatment device is provided with a thermally modulated treatment head adapted for contact with a user's skin. The device includes one or more thermal elements adapted to modulate the temperature of the head, a power source adapted to provide current to the thermal elements, and a controller adapted to modulate the head temperature by controlling the current delivered to the thermal elements. A topical agent can be disposed between the treatment head and the user's skin, where the temperature of the topical agent is modulated to have different temperatures in regions spaced from the skin surface, and proximate the skin surface.
In some examples, the device can be provided with one or more emitters or electrodes configured for electrical communication with the surface of the subject's skin. A voltage or current source can be adapted to generate an electrical waveform for application to the skin surface, via the one or more emitters or electrodes. A controller can be configured for modulating the electrical waveform, so that the pulse width, pulse period, pulse frequency and/or pulse amplitude vary in a periodic, random, pseudorandom, non-repeating or aperiodic manner.
Collagen fibers 125 extend from the lower dermis 110 through the subcutis 120, forming bands and sheets of connective tissue (fascia) connecting the skin (cutis) 100 to the underlying muscles and connective tissue. The dermis 110 also includes a papillary layer 111 and a reticular layer 112, formed of more loosely arranged and denser collagen fibers, respectively.
The subcutis 120 includes adipose tissues 130, for example in the form of lipocytes (fat cells) and intracellular or intercellular lipids, which can form lobules and other structures between the collagen fibers 125. A network of small blood vessels or capillaries 135 provide circulation, extending from the subcutis 120 into the dermis 110.
For example, in one embodiment a current or microcurrent stimulus S can be generated by a skin treatment device 150 with one or more emitters or electrodes 155 disposed along the skin surface 101, either in direct contact with the skin surface 101, or in electrical contact with the skin surface 101 via a conducting topical agent 140. One or more thermal control components 160 can also be provided, in order to modulate the temperature of the topical agent 140 during application.
A current source or waveform generator 170 can be configured to generate a potential (V) or current (I) waveform for application to the skin surface 101 via one or more of the emitters or electrodes 155. It is also possible to use other forms of electromagnetic energy as a form of stimulus S to treat the skin 100, for example in the form of radio frequency (RF), infrared (IR), optical or ultraviolet (UV) light (e.g., low-energy near UV light), or to provide an energetic stimulus S in the form of sonic, subsonic or ultrasonic acoustic energy.
These energetic stimuli can be presented to the skin 100 as a modulated waveform, similar to the modulated waveforms provided in the form of an electrical or current stimulus S. Thus, electrical, electromagnetic and acoustic forms of energy are all within the teachings of the present disclosure, and any suitable combination of these energetic stimuli can be presented in the form of a modulated waveform.
In particular examples, one or more resistive heating elements or thermal control component (“thermal components”) 160 can be used to heat the topical agent 140, adjacent the skin surface 101. On a molecular scale, the transfer and movement of molecules within the topical agent 140 increases with temperature. Heating can also activate ingredients in the agent 140, and allow active ingredients to more rapidly move through the agent 140, across the skin surface 101, and into the epidermis 105, and/or the (upper) papillary layer 111 and (lower) reticular layer 112 of the dermis 110. Heating may also reduce the viscosity of the topical agent 140 (e.g., in gel or fluid form), which will reduce the drag on the skin as the skin treatment device or head is moved over the skin. Using one or more thermal components 160 to modulate the temperature of the topical agent 140, heat from the fluid can also be transferred across the skin surface 101, increasing user comfort by providing a warming sensation, and opening pores in the skin to improve cleansing and absorption of active elements in the agent 140.
As shown in
Depending upon application, a potential V can be provided to the emitters or electrodes 155 to apply a current stimulus S to the top epidermal layer 105 of the skin 100, or a current propagating through the epidermal layer 105 to one or both of the papillary and reticular layers 111, 112 of the dermis 110. The electrical stimulus may also propagates into or through the subcutis 120, promoting a favorable response from both cutaneous and subcutaneous tissues. The stimulus S can thus promote a range of biological responses in epidermal, dermal (cutaneous) and subcutaneous tissues. Alternatively one or more (or all) of the emitters or electrodes 155 can take the form of LEDs or laser light sources (or other electromagnetic emitters) configured to provide a stimulus in the form of RF, IR, optical or UV light energy, or one or more acoustic transducers configured to provide a subsonic, sonic, ultrasonic, or other acoustic stimulus, or any suitable combination of electrical, acoustic, and electromagnetic emitters 155.
Suitable waveforms and waveform modulation techniques are described, for example, in U.S. Publication No. 2021/0308452 A1, “Modulated Waveform Treatment Device and Method,” and in U.S. Provisional Patent Application No. 63/256,106, “Current Control System for Skin Treatment Device,” filed Oct. 15, 2021, each of which is incorporated by reference herein, in the entirety and for all purposes. In particular applications, for example, pulse width modulation (PWM) can be used to generate the stimulus S as a pulsed microcurrent waveform, or other energetic stimulus S, for example by applying a programmed, random or pseudorandom pulse width modulated (PRPWM) current or voltage waveform, or as a modulated electromagnetic or acoustic waveform, as described herein. The power output to the skin surface can also be modulated to reduce transients and increase user comfort, while maintaining treatment efficacy.
In other examples, a DC (direct current) or pulsed DC potential V or current I is applied via the electrodes 155, so that the electrical stimulus S propagates in a particular direction through the skin 100. In other examples, an AC (alternating current) potential V of current I can be applied, so that the electrical stimulus S propagates back and forth, in alternating fashion.
The potential V can be applied as a steady-state (constant or alternating) voltage signal, or using a modulated waveform. Depending on application, the pulse width, amplitude, period and frequency of the applied voltage V or current I can all be controlled, either individually or in combination, in order to generate the electrical stimulus S as an AC, DC or pulsed DC current treatment for the skin 100 of the user or other subject.
Depending on application, device 150 can also a microprocessor (μP) based controller 180 with memory 185, and a power supply (P/S) 175 adapted for operation of the electrodes 155, thermal components 160, waveform generator 170 and controller 180. The microprocessor controller 180 is provided in data communication with memory 185, which provides storage for control code 186 and operational data 188.
The power supply 175 can be provided in the form of a line connection or a rechargeable capacitor or battery system, for example with a power port or charger (C) 178 adapted for external wired or wireless (e.g., inductive) charging of the power supply 175. A communications interface (UF) 190 can be adapted for data and control communications with the controller 180, for example using a hard-wired or wireless communications port (P) 195.
In operation of device 150, power supply 175 provides power to the electrodes 155 via the voltage or current waveform generator (or source) 170, as well as the thermal components 160, sensors 165, controller 180, memory 185, interface 190, and the other internal components of device 150. Controller 180 is configured regulate the potential (V) or current (I) waveform generated by source 170, for example by executing control code 186 stored in memory 185. Control parameters and other operational data 188 can be used for modulating the waveform provided to each selected emitter or electrode 155, in order to deliver the desired amplitude, frequency, and pulse width modulation. One or more sensors 165 can also be provided in direct or indirect contact with the treatment head or skin surface, for example in direct physical contact with the treatment head or skin surface, or in inductive, conductive or thermal communication. Sensors 165 can be configured to measure treatment head and skin surface temperature and resistivity, and to determine other skin conditions such as hydration level, skin firmness, etc. Suitable sensors 165 can also be provided to measure or monitor environmental conditions such as ambient temperature and humidity, etc.
The microprocessor controller 180 can also be adapted to monitor feedback signals from the emitters or electrodes 155, and for regulating the applied potential (V) or current (I) responsive to the feedback. Feedback-based regulation allows the controller 180 to maintain the desired electrical stimulus S, taking into account the number and arrangement of electrodes 155 as well as the subject's skin type and related skin conditions such as resistivity, temperature, hydration, etc., for example as determined with additional data from one or more skin sensors and other environmental sensors 165. The controller 180 can also be adapted to regulate the current stimulus S transmitted through the subject's skin via the electrodes 155, based on the based the voltage (V) or current (I) waveform generated by the source 170, and based on operational and environmental conditions such as the temperature of the skin surface (or topical agent disposed on the skin surface), the impedance of the skin between adjacent electrodes 155, and other operational data include prior (recent or historical) treatment information recorded in the operational data 188.
Generally, this disclosure is directed to the value of heating technology in skin treatment devices, and more specifically to heating technology focused on the topical agent or composition applied to the subject's skin surface (e.g., as a fluid or gel medium). On a molecular scale, the warmer the topical composition, the more rapid the transfer and movement of molecules within the topical medium. Heating can allow active ingredients to more rapidly move through the fluid or gel medium, while reducing the medium's viscosity.
Warming the topical agent to a suitable temperature thus reduces drag between the skin surface and the treatment device, as it moves over the subject's skin. A warmer topical composition can also transfer thermal energy to the skin, providing a beneficial warming sensation and opening pores in the skin surface, to increase penetration of active ingredients.
This approach contrasts with existing technologies, including warming the topical fluid when pumped or otherwise dispensed from a reservoir. This approach requires combining a fluid pump with a heating element, and topical agents that are pre heated before application can quickly cool, and the benefits of heating can be lost within a few seconds. Heating the entire treatment surface, on the other hand, requires high amounts of energy, and can lead to discomfort.
As shown in
Simple, direct heating mechanisms can be used to heat the topical agent to the selected temperature range, as described herein, for example with a minimum power output of about 15.6 W, distributed over one or more a treatment surfaces 250 with an area of about 60 to 80 cm2 or more. Alternatively the thermal power output and treatment surface area may vary; e.g., from less than about 10 W to about 15-20 W, 20-25 W or more, over a treatment area up to about 50 cm2, from about 50-100 cm2, or more. The thermal power output can also be adapted to heat the topical to a desired temperature within a particular time, for example within a minute or less, when the agent is distributed over the treatment area with the device in a static location adjacent the subject' skin. The heating time may also vary, for example from about 30 seconds (or less) to about two minutes (or more), and the thermal power output can also be adapted to maintain the desired topical agent temperature when the device is subject to dynamic movement over the skin surface.
In some configurations, textured or patterned application surfaces 255 comprise a network of branching, intersecting, on interconnected groove or channel structures 260, in a proximal position with respect to the contact element 250 (spaced from the subject's skin), and a complementary network or set of oblong pads, lands, or similar structures 265, in a distal position with respect to the contact element 250 (adjacent the subject's skin). Alternatively, complementary ridged or grooved structures 260 and pads or lands 265 can be formed in parallel, intersecting, branched, concentric, or randomized patterns, or combinations thereof.
Contact elements 250 of
Contact elements 250 can be made from stainless steel, nickel, copper, chrome, silver, and alloys thereof, or other suitable conducting metals or metal alloys. The application surfaces 255 can be formed in a punch and die operation (e.g., from stamped metal plate contact elements 250), or via a plating process, machining, or a combination thereof. Contact elements 250 can also be formed with substantially smooth application surfaces 255, or with grooves or channels 260 and ridges or lands 265 defining rounded nodules, undulating ridges, crossed perpendicular bars, ovals, circles, rectangular or oblong features, triangles, stars, or other textured or patterned geometries, as adapted for a range of different skin treatments and topical applications.
In some configurations, thermal elements 360 are disposed adjacent and along the individual ridges, grooves or channel structures 260 making up the proximal portions of the patterned application surface 255, spaced from the user's skin 100. Air gaps or similar insulating spaces 540 are defined between the heating module 500 with thermal elements 360, and the distal portions or lands 265 of the application surface 255, adjacent the user's skin 100.
Thermal elements 360 are energized by a power supply and controlled by a microprocessor, for example a power supply 175 and a processor-based controller 180, provided in combination with other components of a skin treatment device 150 according to
In some applications, thermal elements 360 comprise resistive heating elements adapted to modulate the temperature of the contact element 250 (e.g., a thermally conducting metal plate), adjacent the topical agent 140 being delivered to the user's skin along the ridged, grooved or channel structures 260. Generally, increasing the temperature of the topical agent 140 will increases the fluid conductivity, and increased fluid conductivity can provide increased ability to deliver active components (e.g., molecular ions), in response to electrochemical effects such as iontophoresis, electro-osmosis and electrophoresis.
In some examples, heating of the topical agent 140 can be concentrated in the grooves or channels 260 adjacent the thermal elements 360, and through which the topical fluid flows for delivery to the subject's skin 100. Limiting heating to the channels 260 can increase efficiency for heating the topical agent 140 (e.g., as opposed to the subject's skin 100), resulting in lower energy demand on the power supply.
Depending on skin type, topical composition, and individual preference, a typical comfort range for the temperature of a topical agent 140 when applied to a subject's skin 100 may be in the range of up to 37-42 C, or up to a comfort limit of about 45 C. Depending upon the design of thermal elements 360 and the size of the treatment head 200, the may be achieved with a power output of about in the range of about 10-20 W, for example about 15.6 W, to produce a desired temperature range on the skin contact element 250, for example after about one minute of operation, or after a few minutes of operation, or less than a minute of operation. Is some examples, this power level range may also be suitable to maintain the desired head and fluid temperature ranges, as the topical agent 140 is delivered along channels 260 while the treatment head 200 is moved across the subject's skin 100. In these applications, suitable rechargeable power sources are can provide a treatment cycle in the range of a few minutes or more, for example five to ten minutes, or more or less.
In some examples, the contact surface 45 is formed of a metal or similar thermally and electrically conducting material, for example by stamping. In other examples, the head 200 can be built with a metal or similar thermally conductive material along the channels 260 adjacent the thermal elements 360, and other portions of the contact element 250 adjacent the skin 100 may be formed of thermally and/or electrically insulating materials, for example using a two-piece metal/plastic or composite contact element 250, or other suitable multi-component form.
Suitable contact elements 250 can be formed with different components having different thermal conductivities, or with a substantially uniform conducting material. Suitable thermal elements 360 can be operated to modulate the temperature of the contact elements 250 at different positions along the treatment head 200; maintaining a temperature profile 256 between the individual thermal elements 360 disposed along the treatment surface 255. For example, the temperature profile 256 can be controlled to define a thermal gradient 258 between the proximal ridge or groove structures 260, spaced from the subject's skin 100, and the lands or similar distal portions 265 of the textured or patterned treatment surface 255, adjacent the subject's skin 100. The temperature profile 256 can be controlled as the head 200 moves across the skin 100, in response to heat absorption through the skin 100, at the nominal skin temperature. Further, the thermal gradient 258 can be generated using a either one-component contact element 250 (e.g., with a metal co0ntact surface 255), or two-component design (e.g., a metal stamped channel structure 260, with plastic or composite skin contact material in the distal or land portions 265, adjacent the skin 100).
In some of these applications, the temperature of the topical agent 140 in channels 260 may increase to about 50-55 C, or up to 60 C, in order to increase activation chemistry in active treatment components of the agent 140. Activation chemistry can be very sensitive to temperature, and the treatment components of topical agent 140 can be activated at higher temperature (e.g., up to 60 C) in the channels 260, spaced from the skin 100, then delivered to skin at lower (more comfortable) application temperature range, along the pads or lands 265 adjacent the skin 100.
In addition to ionization, increased fluid temperature can also affect molecular structure (e.g., resulting in the release of active ingredients in a “caged” molecular structure, or by releasing one or more active topical components that react readily at relative higher fluid temperature in the grooves 260, adjacent the thermal elements 360 and spaced from the subject's skin 100, and then are applied to the skin 100 at relatively lower fluid temperatures along the lands or pads 265, adjacent the skin 100.
In other examples, thermal elements 360 can be provided as a combination or resistive heating and Peltier devices or similar elements 360 adapted to heat one or more skin contact elements 250, or regions within a given element 250, and to cool one or more other contact elements 250, or other regions within a given element 250. This arrangement can be used to enhance the thermal gradient 258 in the topical agent 140 between the subject's skin 100 and the channels 260, spaced from the skin 100. This arrangement can also be used to modulate the temperate of one or more contact elements 250, or different regions within a given element 250, so that the subject experiences different temperatures along or adjacent different pads or lands 265, as the treatment head 200 moves across the skin 100.
Generally, the use of heating channels or other structures 260 to introduce a thermal gradient 258 in the topical agent 140 provides for a more advanced approach to topical skin treatment, defining an in-situ reaction chamber to activate the topical agent 140 at one temperature, and deliver agent 140 to the skin 100 at another temperature. The thermal gradient 258 can be defined to heat the agent 140 to a higher temperature for activation, and to lower the temperature of the agent 140 for application to the skin 100.
Single or multiple skin contact pads or similar elements 250 can be used in a given head 200. The substantially linear or lineal thermal elements 360 can also be replaced with “buttons” or other discrete structures, or with a resistive plate. One or more regions of the treatment head 200 could also be uniform in temperature profile, or comprise a combination of different heated or temperature modulated regions and unheated or unmodulated regions, with textured, patterned or smooth application surfaces 255. For example, the head 200 can be provided with regions of the contact element 250 heated to a temperature range selected to open pores and encourage vasodilation, and other regions cooling to a temperature range selected to close pores and encourage vasoconstriction, while promoting iontophoretic delivery and enhanced permeability for active skin treatment components in the topical agent 140.
One or more thermal components 160 can be incorporated into the textured or patterned application surface 250 adjacent the electrodes 155, for example in the form of discrete thermal elements 360 disposed on the opposite side of the application surface 250, inside the housing of device 150, as shown in
In addition, the temperate profile 256 may tend to be relatively higher proximate the grooved structures 260, spaced from the skin surface, and relatively lower proximate the pads or lands 265, adjacent the skin surface. This defines a thermal gradient in the adjacent topical agent; e.g., as achieved by selected placement of the thermal elements to increase temperature-dependent chemical activity for the topical agent in the grooves 260, spaced from the skin surface, and a relatively lower temperature proximate the lands or 265, where the topical agent is in contact with the subject's skin.
In these examples, the contact element 250 can be formed as a corrugated metal stamping disposed within a plastic or composite frame 152. A heating element can be provided in the form of a laterally extended plate disposed on the opposite side of the contact element 250, adjacent the grooves 260 (spaced from the lands 265), or as a set of linear elements aligned along the grooves 260. Suitable heating elements include a thermocouple plate adapted to the shape of the contact element 250, and extending across the grooves 260, or a set of linear thermocouple elements extending along the individual grooves 260.
Upon application of a topical agent, a thermal gradient is defined between portions of the topical agent adjacent the grooves 260, as compared to the lands 265. Generally, the heat pattern defines hotter spots (higher temperatures) along the grooves or channels 260, forming a warmed reservoir of topical agent for delivery to the subject's skin, with cooler spots (lower temperatures) along the lands 265, after the topical agent is applied the skin surface. The topical agent is applied by movement of the application surface 255 across the skin, distributing the topical by a wiping motion from which the topical flows from the grooves or channels 260 (warmer topical agent, spaced from the skin surface), and across the lands 265 (cooler topical agent, adjacent the skin surface).
A topical agent 140 can be applied to the subject's skin 100. The thermal elements 360 are controlled to alternately cool and heat the conductors 560 on the adjacent, opposing sides of each element 360, providing a temperature differential adjacent the grooves 260 and lands 265. For example, the thermal elements 360 can be oriented to transfer heat from a first conductor 560 extending to a grooved portion 260 of the application surface 255, to another conductor 560 extending to a contact pad or land 265.
In this configuration, a temperature profile 256 is controlled along or across the application surface 255 to establish a thermal gradient 258 in the topical agent 140; e.g., so that the topical agent 140 is relatively warmer in and adjacent the grooves 260, spaced from the skin surface, and relatively cooler toward the contact pads or lands 265, adjacent the skin surface. Alternatively the direction of heat flow via elements 360 may be reversed, from the grooves 260 to the lands 265, so that the thermal gradient 258 defines the topical agent 140 at a relatively cooler temperature in and adjacent the grooves 260, spaced from the skin surface, and at a relatively warmer temperature toward the contact pads or lands 265, adjacent the skin surface.
This disclosure is made with respect to representative examples and embodiments. Each can be used either alone or in combination with any other embodiment or example described or illustrated herein, and each may incorporate additional modifications, changes, equivalents, and alternatives that fall within the breadth of disclosure, as read and understood by a person of ordinary skill, and without departing from practice of the invention as claimed. These various examples and embodiments are provided by way of illustration, and should not be construed to limit the scope of the invention, nor to limit the meets and bounds of coverage as defined by the language of the appended claims.
The application claims priority to U.S. Provisional Patent Application No. 63/209,916, SKIN TREATMENT DEVICE WITH THERMALLY MODULATED HEAD, filed Jun. 11, 2021, which is incorporated by reference herein, in the entirety and for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 63209916 | Jun 2021 | US |