The present apparatus is related to the field of personal aesthetic procedures and in particular to cosmetic skin treatment procedures.
Skin tightening or wrinkle reduction, removal of skin lesions and reduction of subcutaneous fat or adipose tissue, are aesthetic treatments for which there is a growing demand. Types of available aesthetic therapy commonly include the application of different light sources, radio frequency energy and sometimes ultrasound energy
The electromagnetic energy is typically delivered to a target segment of the skin of a recipient by selecting a contact element that is compatible with the treated segment size. Alternatively, a plurality of contact elements may be utilized, in which the plurality of elements contact discrete points of the target segment of the skin. In the latter case, the healing period is typically shorter. Although both modes of treatment are effective, the use of multiple contact elements treating discrete points or fractions of a target segment effectively tightens the skin, reduces wrinkles, and improves the skin appearance. In recent years, noninvasive, non-ablative aesthetic skin treatments have been introduced and may replace ablative skin treatment procedures in the future. In non-ablative skin treatment thermal energy induces certain tissue modification and in particular collagen modification in the dermis. Currently non-ablative skin treatment is used for skin tightening, scar removal, acne treatment, and other aesthetic procedures typically performed in an ambulatory environment.
In non-ablative skin treatment light and/or radiofrequency (RF) energy is deposited 100-2500 μm below the skin surface, where the energy does not affect the epidermis and the skin layer in which most of the skin aging processes occur. With no epidermal wound, there is almost no recovery period and thus no interruption of daily life routines. Transient erythema or mild edema, are the only known side effects and those disappear a few hours after the treatment. The efficiency of the non-ablative treatments is lower than the one of ablative treatments; however, non-ablative skin treatments also stimulate new collagen production and repair tissue defects.
Since there are no side effects and the procedure does not leave wounds requiring a long healing period, the non-ablative treatment is associated with little or no downtime and unlike the ablative skin treatment, which requires professional supervision, non-ablative skin treatment may be used by a lay user in a home environment at a time most convenient for him/her to perform a treatment session such as, for example, skin tightening and wrinkle reduction associated with collagen remodeling.
Both light and Radio Frequency (RF) energy types may be used for these procedures. RF however, does not scatter and, penetrates deeper into the dermis and causes negligible heat sensation on the skin surface.
RF energy is conducted to skin through electrodes. With proper design of RF applying electrodes, RF energy power setting and application time the energy may be accurately conducted to the desired target tissue. For example, the energy application time and power may be shorter than skin thermal relaxation time further simplifying the non-ablative skin treatment. The employment of an applicator that includes disposable parts for electromagnetic radiation skin treatment also simplifies and facilitates aesthetic treatments in a home environment at a time most convenient for the user to perform a treatment session.
An apparatus for personal aesthetic skin treatment by RF voltage. The apparatus includes an assembly of individual electrodes operative to contact fractions of the skin and deliver to each contact RF voltage. The voltage may be a test voltage enabling determination of the quality of the contact between each of the electrodes and the skin and skin treatment voltage. The treatment voltage heats the skin and is applied only to electrodes being in proper contact with the skin. Appropriate skin treatment protocols are stored in the apparatus and the selected skin treatment protocol sets the number of electrodes to which RF voltage and the magnitude of the voltage applied. The selected protocol and skin treatment parameters ensure safe non-ablative skin treatment.
Typically, the electrodes are assembled on a common substrate or carrier that may be a reusable or disposable carrier. In course of the treatment the applicator with the carrier is applied to the skin in a patch-like step motion or moved in a sweep like movement over the treated skin segment.
The term “carrier” in the context of the present disclosure means a substrate having an array of voltage to skin application elements or electrodes. The electrodes may be in the form of one or more rows of voltage-to-skin application elements, a two dimensional array or matrix of voltage-to-skin application elements and a three dimensional shape substrate having on its external surface voltage-to-skin application elements.
The terms “electrodes”, “conductive elements”, “contact elements” and “voltage to skin application elements” are used interchangeably in the present disclosure and mean elements operative to receive voltage from a source such as, for example, an RF voltage generator and apply the received voltage to the skin, or serve as a return electrode.
The term “skin treatment” as used in the present disclosure includes aesthetic or cosmetic treatment of various skin layers such as stratum corneum, dermis, epidermis, skin rejuvenation procedures, pigmented lesions removal, and such procedures as collagen shrinking or destruction. The terms “RF voltage” and “RF power” are used interchangeably in the present disclosure. The mathematical relation between these two parameters is well known and knowledge of the value of one of them enables easy determination of the value of the other parameter.
The term “a large segment of skin” as used in the context of the present disclosure, means a segment of skin dimensions of which exceed the dimensions of the surface of the carrier, or circumference of the surface of the contact electrode or electrodes carrier.
Various embodiments of the present apparatus, including method and apparatus embodiments, are disclosed and presented, by way of nonlimiting examples only, with reference to the accompanying drawings, wherein like numerals depict the same elements throughout the text of the specifications. The present apparatus and skin treatment method will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:
Reference is made to
Apparatus 100 is intended for personal aesthetic skin treatment and in operation it heats skin segments and/or volumes in contact with the electrodes and between the operating electrodes. As will be explained below, operational parameters of apparatus 100 are set to heat the skin only and not to cause skin ablation. Nevertheless, skin ablation may be accidentally initiated by improper or insufficient electrode to skin contact or occasional skin defects.
Controller 112 could include a mechanism 158 having a memory 160 that stores and retrieves different skin treatment protocols and sets the skin treatment parameters according to the retrieved skin treatment protocol, which could be a non-ablative skin treatment protocol. Memory device 160 may communicate with controller 112. Controller 112 communicates with each of the sensors, receives from the sensors treatment status signals. Memory device 160 stores treatment protocols or instructions which, when executed by the controller, cause the controller to detect the quality of the contact between the electrode and the skin; determine the number of electrodes to be operated simultaneously; retrieve appropriate skin treatment protocol and set the treatment parameters according to the retrieved a skin treatment protocol. The selected protocol and skin treatment parameters ensure safe skin treatment, which may be non-ablative skin treatment. Additionally, controller 112 in course of treatment may adjust the skin treatment parameters according to the received signals if deviations of the set or predetermined protocol exist. For safety reasons apparatus 100 also includes skin treatment safety measures such as a skin ablation detecting mechanism 144 operative to monitor the ongoing skin treatment status and detect situations in which ablation has been initiated. When such a situation is detected the information is communicated to controller 112 that, in turn, adjusts the skin treatment parameters accordingly to maintain a non-ablative skin treatment. RF generator 116 has a plurality of exists and provides RF voltage independently and individually to each of the skin contacting elements or electrodes 132. The voltage may be a test voltage enabling determination of the quality of the contact between each of the electrodes and the skin and skin treatment voltage and/or a treatment voltage.
Selection of the number of simultaneously operating individual electrodes enables addressing and RF voltage delivery to the entire assembly or array of skin contacting elements or electrodes 132, a group of the array of skin contacting elements 132 and as noted to each of the skin contacting elements 132 individually. Depending on the configuration of carrier 128 RF electrodes 132 may be configured to operate in a mono-polar or bipolar mode. Apparatus 100 may also include a display 150 operative to provide to the user information on the skin treatment process progress and/or a graphic map of the last treatment application. Display 150 may be an Organic Light Emitting Diodes (OLED) display, a Liquid Crystal Display (LCD) or a matrix of Light Emitting Diodes (LED) that among others could display for each electrode electrode-to-skin contact status.
In the asymmetric carrier configuration such as that shown in
In the currently used aesthetic skin treatment asymmetric applicator tip carrier 200 the return path between the outermost electrodes (that could have a pin type shape) 208 and return electrode 204 is the shortest current path having the lowest return impedance. Because of this a greater amount of RF power is delivered along this short return path, again, potentially generating a higher temperature in the adjacent skin segment or volume than in the rest of the treated skin segment or volume. Voltage-to-skin applying elements or electrodes may be produced by different methods. Typically, methods used in printed circuit board production may be suitable for voltage-to-skin applying elements or electrodes production. These methods enable low cost production of a large amount of carriers populated by electrodes. Depending on the type of processing and material deposition the voltage to skin applying elements may be flat, protruding from the surface on few microns, few tens of a millimeter, or more as desired. By proper selection of the metal deposition process the voltage to skin applying elements may be made of spherical or higher order shape. The substrate 200 of the carrier 128 on which the electrodes 204 and 208 reside is common to all electrodes and may be made of a variety of materials, typically insulating materials. Non-limiting example of a suitable material includes polyimide film, paper, or similar material, with a thickness of 0.5 mil to 60 mil (12.5 micron to 1500 micron). Carrier 128 is configured to allow quick attachment to apparatus 100.
Depending on the desired use the carrier may be implemented as a reusable or disposable carrier. When the same person is repeatable using the apparatus it may prefer a reusable carrier. If more than one person employs the apparatus, a disposable carrier may be preferred.
Temperature sensors 240 (
Generally, but not necessary, electrodes 612 may be located on a grid. The grid may have equal dimensions in both X and Y dimensions (square grid), although in some embodiments the distance in the X and Y directions may be different. The carrier electrodes 604 and 608 are configured such that in course of skin treatment one or more of the electrodes are in contact with the skin. Usually, a plurality of electrodes may be in contact with the skin at a plurality of skin locations. By changing the shape of the electrodes and distance between the electrodes in X or Y direction it is possible to produce different skin treatment patterns by different carriers and by changing the size and distance between electrodes 604 and 608 it is possible to affect the depth of the treated skin layer. Electrodes 604 and 608 could be made of a rigid, semi-rigid or resilient electrically conducting material. Resilient electrodes conform to the skin relief more easily and enable better contact with the treated skin segment than the rigid electrodes enable. Resilient electrodes may be produced by coating the copper electrodes by a conductive and resilient coating such as for example a conductive silicone. The electrodes may be arranged in an array such as that shown in
The dimensions of the carriers illustrated above on which the arrays of corresponding voltage to skin applying elements or electrodes are mounted or assembled determines the size of the affected skin surface of the treated skin segment. Current sizes of carriers bearing the voltage applying elements range from 5×5 mm2 to 25×25 mm2 or 30×30 mm2. The affected skin surface is generally equal to the size of the carrier on which the electrodes are mounted. The arrays of electrodes may be located on the surface of the carriers, as an evenly or randomly spaced matrix of, for example but not limited to, 2×2 electrodes, 4×4 electrodes, 12×12 electrodes, 16×16 electrodes, 16×24 electrodes, or any other number and configuration of the electrodes. Concerning the various embodiments, the term randomly is intended to include true randomness, as well as pseudo randomness or even predictive sequencing of the operating electrodes with a variety of sequences. Carrier design and size may be scaled-up or scaled down as desired or optimal for a particular treatment or size of area to be treated. For example, for a cosmetic treatment of different body segments the carrier may have a size of 60×60 mm or more. Generally, the ability of supplying proper treatment power may be the size limiting factor. The diameter of the electrodes 208, 308 and 408 may be about 100 to 2000 micron and their size is usually selected such as to avoid formation of high density currents that may lead to skin ablation formation. In some embodiments, the electrodes may be configured in a pattern adapted to treat certain skin area having an irregular shape or surface.
RF voltage is proper coupled to skin when the contact between the skin and RF coupling electrode is such that most of the electrode surface is in contact with the skin. Electrodes being in partial contact with the skin may cause overheating of the treated skin segment; damage it and even initiate ablation. Apparatus 100 includes an electrode-to-skin contact detecting mechanism 136 (
Adapting the aesthetic treatment for personal use in the home environment requires automating the control of skin treatment parameters and introducing safety features to avoid over treatment of any particular segment of skin. Typically, the selected protocol and skin treatment parameters ensure safe skin treatment, which may be non-ablative skin treatment. Additionally, features such as, but not limited to, limiting the number of the voltage to skin application elements or electrodes activated at any one time, providing electrodes with relatively large contact surface, gradual application and/or activation of the power provided to skin application elements in a predetermined specific sequence may all contribute to the safety and comfort of the home aesthetic skin treatment, and ensure safe skin treatment.
When one of the carriers described above is applied to a segment of skin 820 to be treated not all electrodes as shown in
The retrieved from memory 160 skin treatment protocol and treatment parameters may be applied to heat the treated skin segment by delivering to the selected electrodes a skin treatment RF voltage. There may be any number of selected electrodes for example one electrode, four electrodes, seven or more electrodes provided the number of the selected electrodes ensures safe treatment. Typically, the number of activated electrodes would be at least four or six or even more electrodes. If a carrier such as carrier 628 (
Different electrode selection criteria may be applied to the treatment based on a predetermined treatment protocol and input from the electrode-to-skin contact detection mechanism. The criteria may include the number of adjacent simultaneously active electrodes, randomly located electrodes and others. The controller may monitor the current flowing through the activated electrodes to ensure the activation of only the desired electrode at any one time, where the remaining electrodes are not operative at that time.
As mentioned above, the temperature of the different treated skin segments being in contact or located in the vicinity of the active electrodes may be monitored to avoid sudden temperature raise and deviation from the currently applied skin treatment protocol. Skin temperature increase over the temperature set by the treatment protocol may cause conversion of the skin heating process into a skin ablation process. In order to avoid this conversion a skin ablation detecting mechanism may monitor the skin treatment status and communicate the status reading or information to controller 112 (
For treatment of the next target segment of skin, the apparatus may be moved (translated) over the skin in a patch-like step motion and be applied to the next target segment of skin to be treated. Alternatively, the apparatus could be moved in a sweep like movement over the treated skin segment. U.S. patent application Ser. No. 12/324,932 to the same assignee and to a common inventor discloses electrode carriers representing bodies with a rotational symmetry. In some embodiments of the present apparatus, as shown in
To achieve sufficient heat penetration into the dermis and satisfactory aesthetic treatment results, the electrodes are activated for a period of time in the range between 25 msec and 10000 msec. Other typical operating parameters of the apparatus may be: Voltage on high impedance load would be about 450 Vpp causing a current of 50 400 mA. The RF is usually supplied in pulse form with energy per pulse (Actual energy delivered to the skin) of 0.54 J, more typical 12 J. Generally, in home use devices employing low voltage settings there may be no need for cooling the electrodes or the treated skin segment and thus, almost all treatments may be performed with an apparatus that does not employ dedicated cooling means.
It should be understood that treatment applied with the above described apparatus is a noninvasive treatment. The contact elements or electrodes do not penetrate and do not introduce damage to the skin being treated. The RF voltage applied does not break through or damage the skin. Upon completion of the patient skin treatment, the carrier used to apply or distribute the voltage to the target segment of skin may be removed from the apparatus and be disposed of. It should also be noted that the exemplary carriers, although disposable upon completion of the treatment, may also be reused for a number of repeated treatments by the same subject.
Additionally and/or optionally as shown in
The color OLED or other type of display may also provide other information such as display a map of the areas being treated at the time of the display as well as inoperable (defective) electrodes, such as electrodes receiving power but not generating heat in the skin volume below the electrode.
Full or proper contact between the electrodes and the skin may be improved and almost ensured by use of electrically conducting gel. Use of gel improves not only the contact of the electrodes with the skin, but also prevents skin ablation formation points.
For in home self-use apparatuses, the voltage applied to the treated segment of skin is sufficiently low to prevent ablation of the skin yet enabling sufficient generation of heat in the sub-epidermal layers to promote, for example, skin tightening and wrinkle reduction and other cosmetic treatments associated with collagen remodeling.
The present apparatus and method have been described using detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the disclosure. The described embodiments comprise different features, not all of which are required in all embodiments of the apparatus. Some embodiments of the present apparatus and method utilize only some of the features or possible combinations of the features. Variations of embodiments of the present apparatus that are described and embodiments of the present method comprising different combinations of features noted in the described embodiments will occur to persons of the art.
While the exemplary embodiment of the present method and apparatus has been illustrated and described, it will be appreciated that various changes can be made therein without affecting the spirit and scope of the apparatus and method. The scope of the method, therefore, is defined by reference to the following claims:
Number | Date | Country | |
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61375054 | Aug 2010 | US |
Number | Date | Country | |
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Parent | 13853393 | Mar 2013 | US |
Child | 15421561 | US | |
Parent | PCT/IL2011/000630 | Aug 2011 | US |
Child | 13853393 | US |