The present disclosure relates to treatment of mammalian tissue, in particular human skin and subdermal tissue, more in particular it relates to heat treatment by radiofrequency energy for skin tightening and/or skin rejuvenation.
It is known that human skin may be rejuvenated if the skin is intently heated to a temperature that is significantly above normal body temperature so as to induce intently small-scale tissue injury and/or minor damage, collagen denaturation and/or coagulation, tissue ablation and/or necrosis. This urges the body to respond by restoring the damaged tissue, which results in the desired tightened and rejuvenated skin.
For successful treatment, the target tissue zone or treatment zone should be properly addressed and other tissue should be spared. The treatment zone for skin rejuvenation is generally in the cutis (epidermis and dermis) and subcutis. For localized heating, U.S. Pat. No. 7,955,262 discloses a system and method for treating skin, to obtain the aesthetic effect of skin rejuvenation by using radiofrequency (RF) energy to heat the tissue. The RF treatment is preceded by first directing acoustic energy at ultrasound wavelengths to the skin surface. This provides a first heating of the tissue at the focal volumes of the ultrasound energy. RF energy is subsequently applied to the skin and the RF current is guided into the focal volumes preheated by the ultrasound energy. According to U.S. Pat. No. 7,955,262 it is believed that this guiding effect is based on the temperature dependence of RF conductivity on the tissue temperature and to prevent damaging of tissue surrounding focal volumes to be heated and the remainder of the treatment zone, the treated zone should preferably be cooled prior to application of the energy sources.
However, ultrasound tends to interact with biological tissues not only thermally but also mechanically (even at low pressure levels), specifically by the generation of cavitation bubbles, which is deemed undesirable and unsafe for biological tissues. Furthermore, scattering of deep-penetrating focused or unfocused ultrasound energy can result in hotspots inside tissues which is a serious safety concern. Control of the amount, location and temperature of the pre-heating and therewith of the RF heating, and thus of the treatment as a whole, is therefore inadequate or at least very complicated.
In order to improve skin tissue therapy the method and system defined in the appended claims are provided herewith.
The method of skin tissue treatment, in particular being a method for cosmetic skin tightening and skin rejuvenation, comprises the steps of: determining a treatment zone within the skin tissue below the skin surface; modifying an electrical conductance property of at least two first skin tissue portions present on opposite sides of the treatment zone with respect to a direction parallel to the skin surface and providing radiofrequency energy to the treatment zone to heat the treatment zone. The step of the modifying said first skin tissue portions comprises decreasing electrical impedance for the radiofrequency energy, in particular increasing electrical conductance, of said first skin tissue portions relative to a second skin tissue portion present between said first skin tissue portions and such that said first skin tissue portions with a decreased electrical impedance extend into the skin tissue substantially from the skin surface to the treatment zone.
The first skin tissue portions, hereafter also called “low-impedance portions”, provide channels into the skin to the treatment zone within the skin having reduced losses for radiofrequency (RF) energy compared to skin tissue surrounding the first skin tissue portions that is not modified. Due to the effectively increased conductance with respect to the surrounding tissue, the RF energy is preferentially guided to the treatment zone by said low-impedance portions and dissipation of the RF energy in the first skin tissue portions is reduced compared to skin tissue that is not modified. This improves effective penetration depth of the RF energy and it improves accuracy of the application of the RF energy, as well as increases the usable RF energy in the treatment zone. Due to the low-impedance portions extending substantially from the skin surface to the treatment zone or, depending on the point of view, from the treatment zone up to the skin surface, electrical contact resistance between the source of RF energy and the low-impedance portion is decreased, improving incoupling of the RF energy into the channels improving effectiveness of the method.
The low-impedance skin tissue portions may be, but need not be, substantially straight.
In another aspect, a system for skin tissue treatment, in particular for performing one or more aspects of the method generally outlined above is provided herewith. The system comprises a radio frequency source for providing radio frequency energy to the treatment zone of the skin tissue to heat said treatment zone, comprising a radiofrequency (RF) energy source with one or more radiofrequency electrodes. The system further comprises a modifier configured to modify an electrical conductance property of at least two first skin tissue portions for guiding the radio frequency energy from the one or more radiofrequency electrodes through said first skin tissue portions to the treatment zone. The modifier for modifying an electrical conductance property of at least two first skin tissue portions for guiding the radiofrequency energy from the one or more radiofrequency electrodes through said first skin tissue portions to the treatment zone for guiding the radiofrequency energy from the one or more radiofrequency electrodes through said first skin tissue portions to the treatment zone. The modifier is configured to decrease the electrical impedance for the radiofrequency energy, in particular increase electrical conductance, of at least two first skin tissue portions relative to a second skin tissue portion present between said first skin tissue portions, wherein the first skin tissue portions are present on opposite sides of the treatment zone with respect to a direction parallel to the skin surface and extend into the skin tissue substantially from the skin surface toward the treatment zone. Advantageously, the device for locally increasing electrical conductance is configured to heat skin tissue and/or to provide a fluid-filled cavity in the skin tissue.
The method of claim 2 and likewise the system of claim 9 facilitates guiding of the RF energy into the treatment zone since the path of least resistance for the RF energy extends between the portions of the first skin tissue portions that are closest to each other. In case of substantially straight channels extending toward each other within the skin tissue, such low-resistance path extends between the respective tips of the channels. In case of one or more curved channels and/or having a varying width along the axis of extension, a close separation may also be provided at one or more other portions than the tips along the length of one or both channels.
The method of claim 3 employs the positive correlation of heating of skin tissue tending to increase its electrical conductivity. Localised heating of skin tissue may be realised by various reliable techniques. A further benefit of the method is that heating of the skin tissue may be non-invasively and transient, leaving no lasting effects. In another embodiment, the heating may cause thermal injury, which may be beneficial for inducing skin rejuvenation as well.
The system of claim 10 facilitates accurate control over heating of one or more skin tissue portions to decrease the electrical impedance thereof. Laser beams may be reliably directed, focused, power-controlled, intensity controlled and/or switched etc. with well-proven technology. Numerous Lasers emitting different wavelengths, powers etc. with associated different effects are commercially available. In particular infrared (IR) radiation wavelengths in the infrared spectrum between about 1-10 micrometers show useful combinations of penetration depths and absorption into mammalian, in particular human, skin tissue. Combinations of plural wavelengths may be used to provide particular electrical impedance variations in the skin tissue, e.g. with respect to size and/or location within the skin tissue.
The method of claim 4 and likewise the system of claim 11 benefits from the effect that ablating skin tissue provides a layer of heated skin tissue adjacent the ablated zone which has a relatively high electrical conductivity, whereas the burnt tissue or ablated zone has a relatively very low electrical conductivity compared to unaffected tissue. Hence, the low-impedance zone is well-defined and RF energy may be directed away from the burnt or ablated zone and guided more effectively into the surrounding tissue.
The method of claim 5 and likewise the system of claim 12 facilitates providing a large difference in impedance between the fluid-filled cavities and the surrounding tissue. Said cavity(s) may be formed by the application of the fluid itself by a suitable dispenser, e.g. due to an injection with a physical applicator such as a hollow needle, a syringe and/or by direct dispensing the fluid in the form of a forceful fluid jet.
In an aspect, a cavity may be made in the skin tissue by burning and/or ablating tissue.
The fluid may be provided from an external source, e.g. water, saline, etc. and/or comprise a body fluid of the treated subject, e.g. interstitial fluid, lymph and/or blood. The latter method may efficiently be combined with burning or ablating a tissue portion to provide an open cavity that is at least partly filled with a body fluid, where the conductance of heated skin tissue adjacent the cavity is exploited concurrent with and/or directly subsequent to the burning and/or ablation step and during the filling of the cavity with body fluid that takes over the role of the high-conductivity portion as the tissue cools.
Filling such cavity with one or more body fluids may be assisted by applying a pressure difference across one or more of said cavities between the skin tissue and the surrounding atmosphere, e.g. by applying a negative pressure or suction to the cavity(s) and/or applying positive pressure to tissue adjacent the cavity(s).
The method of claim 7 improves incoupling of the RF energy into the low-impedance skin tissue portion by reduction of the physical (and electromagnetic) path length between the electrodes and said skin tissue portion(s).
The system of claim 14 facilitates providing close contact between the RF electrodes and the low-impedance skin tissue portion, at least a portion of the first and second patterns may be substantially identical.
Closest contact is direct physical contact with said skin tissue portion(s). The electrical contact may be improved by use of impedance matching fluids, e.g. conductive creams and/or gels. In an advantageous embodiment, plural RF electrodes are used, each in close contact with another low-impedance skin tissue portion. The electrodes may wholly or partly surround and/or overlap the positions of the skin surface in which the modifier interacts with the skin tissue.
In the drawings:
It is noted that in the drawings, like features may be identified with like reference signs. It is further noted that the drawings are schematic, not necessarily to scale and that details that are not required for understanding the present invention may have been omitted. The terms “upward”, “downward”, “below”, “above”, and the like relate to the embodiments as oriented in the drawings. Further, elements that are at least substantially identical or that perform an at least substantially identical function are denoted by the same numeral.
When an RF signal is applied to the electrode 5, the RF energy will flow through the low-impedance portions 11 and through the skin tissue present between them, which will be heated thereby. Due to the reduced impedance and in accordance with Ohms law, the RF energy will preferentially flow through the low-inductance portions 11 rather than through skin portions with higher impedance. Hence, the RF energy will penetrate relatively deep into the skin tissue 1, so that a treatment zone 9 extending deep into the skin 1 or localized deep within the skin 1 may be treated effectively and controllably by appropriately forming the first skin tissue portions 11.
In the embodiment of
Without wishing to be bound by any specific theory and for general understanding of the working principles of the presently provided method, consider the following with reference to
The RF heating mainly occurs at the location where the tissue has the highest current flow and resistance. Specifically, the locally produced heat Qi equals the locally deposited power and is proportional to the square of the local current I multiplied by the local electric resistance R (series circuit) as
Q∝I
2
R. (Eq. 1)
Since the current is dependent on the electric potential V and resistance as
I=V/R, (Eq. 2)
the heat produced can be expressed as
Q∝V
2
/R. (Eq. 3)
Note that this shows that one can indeed guide the electric current flow and consequently localize heating by modifying the tissue's resistance. In the present disclosure the tissue is locally heated and/or fluid-filled to guide the electric current into deep areas of the skin, allowing deeper penetration of RF energy into the skin.
In
ΔT3∝Q3/l3A3. (Eq. 4)
This can be rewritten, using Eq. (1), as
ΔT3∝I32R3/l3A3. (Eq. 5)
Since I3=V/(R2+R3+R2) and Ri=li/(σiAi), the depth-dependent temperature change can be expressed as
ΔT3(d)=σ3/{(2σ3d/σ2 cos θ)−(2d tan θ)+l1}2. (Eq. 6)
Human skin tissue is generally electrically conductive. For an RF frequency of 1 MHz, the electrical conductivity C of different types of human tissue is given in Table 1, in units of S m−1 (from: Sadick and Makino in: Lasers in Surgery and Medicine 34:91-97 (2004)).
Further, the thermal coefficient of the skin conductance is approximated to be 2% ° C.−1 (Sadick and Markino, op.cit.), so that raising the tissue temperature lowers the electrical resistance of the tissue.
The results of detailed numerical simulations of different parameter configurations are shown in
In the simulations the skin surface temperature is maintained at normal human skin temperature of 34° C. by suitable cooling, and the first skin tissue portions 11 are prepared by heating columns of skin tissue to 70° C. This temperature was maintained constant as well. The first skin tissue portions 11 are generally columnar with a length along the longitudinal axis A of about 1 mm, and extend at an angle θ into the skin. The RF electrodes have identical sizes as the first skin tissue portions and both are at a separation at the skin surface 3 of about 1 mm or 1.4 mm in the case of
Taking the values of Table 1, and assuming substantially constant resistance at the used RF frequency yields
σ3=σ(T=35° C.)≈0.25
σ2=σ(T=70° C.)≈0.50
Further, the distance between the RF electrodes on the skin surface 3l1 is taken to be 5 mm and equal to the local separation of the first skin tissue portions 11.
In
It is noted that application of RF energy to skin also the temperature of the low-inductance skin tissue portions will increase. This may be suitably employed for skin treatment as well.
For some treatments the RF frequency of choice may differ from 1 MHz.
Larger diameters of the first skin portions are found to guide the RF energy better than smaller diameters. Providing plural low-impedance portions adjacent each others to form an array (e.g. in a generally linear direction) improves guiding of the RF heating between the electrodes. Without such array, the RF energy dissipation is distributed over a larger volume of tissue.
In the simulated configurations, the heat flux that is created by the RF electrodes placed on the skin surface on top of the first skin tissue columns can easily be removed by surface cooling, if so desired, e.g. to better localise the treatment zone within the skin below the skin surface.
It is expected that instead of using heated skin tissue portions, ablated portions filled with high conductance liquid are used, the result will be an even better guiding (see also below).
Similar to the 3 dimensional geometry presented above, it has been calculated that for a substantially 2-dimensional geometry, e.g. plate-like first skin tissue portions extending adjacent each other at constant separation, for an angle θ=ca 30° (α=ca. 120°), a substantially homogenous temperature increase profile may be found, whereas for an angle θ>ca 30° (or conversely α<ca. 120°), the heating occurs predominantly deep within the skin with a decreasing gradient towards the skin surface 3, as shown for the 3-dimensional case.
It is noted that laser beam(s) need not be stationary and/or used for illumination at one position, but a laser beam position and/or angle may be adjusted with the appropriate optics, such as manually and/or machine adjustable optics e.g. piezo-mounted optics, acousto-optics, electro-optics, stepper motors etc, to provide different optical energy distributions and/or define plate-like heated or ablated shapes and/or more complex illumination profiles, concurrently and/or subsequently.
As set out above, it has been found out that ablating skin tissue producing one or more small cavities in the skin may invoke the rejuvenation process.
The basic principle of the method is that increasing the local conductance of the skin tissue enables RF energy to be guided to the treatment zone. This can be achieved by changing the tissue temperature or composition in the local zones to obtain a reduced impedance. Examples are simultaneous tissue heating or thermolysis of pre-defined geometries, e.g. pillars, plates, and/or combinations of these shapes leading to more complex zones, straight or angled zones, parallel edges or conical/tapered zones, etc. Subsequently, the RF energy will be applied via the thus prepared skin tissue zones.
The size, e.g. the diameter, of the photothermolysed or ablated tissue of first skin tissue portions is preferably about 1 micrometer or larger, preferably between 50-800 micrometer. Merely heated zones may be larger still. For laser-heated skin tissue, the water absorption coefficient of the tissue should preferably be >1 cm−1. Light wavelengths in a range of about 0,1 micrometer to about 20 micrometer can be used to create the low-impedance skin tissue portions.
In skin treatment application systems relating to creation of photothermolysed lesions a focused pulsed laser at a wavelength of about 1 micrometer or longer may be used, preferably having a wavelength in the range of about 1.2-3 micrometer, with a pulse width of less than about 50 ms, preferably with a pulse length in the range of about 0.1-40 ms, with a fluence higher than about 1 J/cm2, preferably between about 10-60 J/cm2.
Suitable lasers and wavelengths for heating may be solid state lasers at a wavelength of about 1.3-1.5 micrometer, focused to produce heated skin tissue portions and/or lesions with typical dimensions of about 200-250 micrometer diameter or width, depending on the shape of the heated skin portion, although the diameter of the focus spot size may be smaller or larger. Suitable lasers may be pulsed at 9-11 mJ and 7.5-10 ms per pulse, resulting in a fluence of about 20-35 J/cm2, and having a penetration depth into skin tissue of about 300 micrometer.
Suitable lasers and wavelengths for creation of ablative lesions may be solid state and/or gas lasers at a wavelength of about 2.5-11 micrometer. E.g. 2.9 micrometer wavelength Er:YAG, focused to about 100 micrometer diameter spot size, pulsed at 9-11 mJ and 2.5-5 ms per pulse. Or, CO2 laser at 10.6 micrometer wavelength, focused to about 120-200 micrometer diameter spot size, at 50-80 mJ and 0.2-3 ms per pulse, and having a penetration depth of about 500-750 micrometer into human skin tissue. Pulsed CO lasers at a wavelength of 5.3 micrometer could also be used.
Skin ablation could also be provided by high power short pulse length lasers in the femtosecond range, e.g. Nd:YAG or Yb:YAG high power diode lasers. Further optical devices and techniques to provide suitable wavelengths, energies and/or heating or ablative effects may be suitably employed.
The treatment methods and systems disclosed herein may be used in a domestic environment but are also quite suitable for professional use for cosmetic treatment in a beauty salon, possibly in a cosmetic medical environment.
Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measured cannot be used to advantage. A computer program may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunication systems. Any reference signs in the claims should not be construed as limiting the scope. Elements and aspects discussed in relation with a particular embodiment may be suitably combined with elements and aspects of different embodiments within the scope of the appended claims.
Filing Document | Filing Date | Country | Kind |
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PCT/IB2013/052912 | 4/12/2013 | WO | 00 |
Number | Date | Country | |
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61624521 | Apr 2012 | US |