Patent Publication Number: US-9889297-B2

Title: Reduction of RF electrode edge effect

Description:
FIELD OF THE INVENTION 
     The invention relates generally to bipolar radio frequency (RF) energy treatment devices, and more particularly, to improving the delivery of RF electrical energy to tissue by improving the spatial uniformity of energy delivered to skin or other tissues. 
     BACKGROUND 
     Many aesthetic dermatologic procedures resort to delivering thermal energy to skin or underlying subcutaneous tissue as a means to stimulate a therapeutic effect. Procedures such as skin resurfacing, skin tightening, wrinkle reduction, hair reduction, tattoo removal, body contouring, and treatments for excessive sweating, sebaceous gland production, acne, pigmented lesions, vascular lesions and blood vessels take advantage of heat to achieve a desired effect. Many different technologies can be used to heat the skin and/or underlying tissues including lasers, incoherent light sources, radiofrequency electrical energy sources, and ultrasound energy sources. 
     A problem with delivering RF energy to tissue is the fundamental concentration of current density along the edges of the electrode in contact with tissue. For monopolar RF energy delivery, higher skin surface temperatures occur along the entire perimeter of the electrode. For bipolar RF energy delivery, the concentration of current also occurs along the edges, but even higher current densities occur along the inner two edges forming the gap between the two electrodes having the shortest electrical path. These non-uniform thermal effects limit the amount of energy that can be delivered to tissue so as to avoid adverse skin effects such as burns, blisters, and erythema. 
     SUMMARY OF THE INVENTION 
     The invention, in various embodiments, features a method and apparatus that uses a semiconductive material applied to an electrode that optimizes electrical energy delivered to tissue while minimizing thermal hotspots around edge of the electrode. The semiconductive material can be a ceramic material, and can have a specified electrical conductivity to improve the spatial uniformity of energy delivered to skin or other tissues. The semiconductive material can be a cap on the electrode, and can be graded to be thicker at the edges of the electrode than in the center. For bipolar RF delivery, the ceramic can be asymmetric so that it is thicker along its inner edge compared to its outer edge. The inner edge is the edge adjacent to the next closest electrode. The ceramic material is also selected to have a high thermal conductivity so that heat at the metal electrode-ceramic junction is carried away via a heat sink and does not accumulate causing unwanted skin surface heating. In addition, the ceramic can have a low coefficient of thermal expansion and be relatively scratch resistant. 
     In one aspect, there is an applicator for bipolar RF energy delivered through a skin surface. The applicator includes a base, a first electrode connected to the base, a second electrode connected to the base, a first semiconductive cap disposed on a first distal end of the first electrode, a second semiconductive cap disposed on a second distal end of the second electrode, and a source of RF energy in electrical communication with the base. The first electrode extends from the base toward a first location of the skin surface. The second electrode extends from the base toward a second location of the skin surface, and is laterally offset and has opposite phase from the first electrode along the skin surface. The first semiconductive cap has a first blunt surface adapted to contact the first location of the skin surface and a curved surface affixed to the first electrode. The second semiconductive cap has a second blunt surface adapted to contact the second location of the skin surface and a second curved surface affixed to the second electrode. The RF energy is delivered from the first electrode and the second electrode through the first semiconductive cap and the second semiconductive cap, respectively, through the skin surface. A thickness of each semiconductive cap between the blunt surface and the curved surface is thicker at an inner portion and thinner at a center portion to homogenize the electrical field at the skin surface. The applicator can receive the RF energy from a source of RF energy. 
     In another aspect, there is a method for treating a skin surface with bipolar RF energy. A first semiconductive cap disposed on a first distal end of a first electrode and a second semiconductive cap disposed on a second distal end of a second electrode are applied to the skin surface. RF energy is delivered from the first electrode and the second electrode through the first semiconductive cap and the second semiconductive cap, respectively, through the skin surface. A thickness of each semiconductive cap between a blunt skin contacting surface and a curved surface affixed to a respective electrode is thicker at an inner portion and thinner at a center portion to homogenize the electrical field at the skin surface. 
     In still another aspect, there is an apparatus for treating a skin surface with bipolar RF energy. The apparatus include means for applying to the skin surface a first semiconductive cap disposed on a first distal end of a first electrode and a second semiconductive cap disposed on a second distal end of a second electrode and means for delivering RF energy from the first electrode and the second electrode through the first semiconductive cap and the second semiconductive cap, respectively, through the skin surface. A thickness of each semiconductive cap between a blunt skin contacting surface and a curved surface affixed to a respective electrode is thicker at an inner portion and thinner at a center portion to homogenize the electrical field at the skin surface. 
     In other examples, any of the aspects above, or any apparatus, system or device, or method, process or technique, described herein, can include one or more of the following features. 
     In various embodiments, the source provides the RF energy at a frequency of about 100 kHz to about 10 MHz (e.g., about 1 MHz). The source can provide the RF energy at about 10 J/cm 3  to about 500 J/cm 3  (e.g., about 50 J/cm 3  to about 120 J/cm 3 ). The source can provide the RF energy in pulses of about 0.1 second to about 1 second. 
     In various embodiments, the conductivity of each semiconductive cap is matched to conductivity of the skin. The conductivity of each semiconductive cap can be matched so that about 10% of the RF energy is lost to the semiconductive cap. The conductivity of each semiconductive cap can be about 0.1 S/m. 
     In various embodiments, each semiconductive cap tapers from an inner edge to the center. The thickness of each semiconductive cap between the blunt surface and the curved surface can be thickest at the inner portion, thinnest at the center portion, and thicker than the center portion but thinner than the inner portion at an outer portion. 
     In various embodiments, each semiconductive cap includes a semiconductive ceramic. Each semiconductive cap can include a conductive silicon carbide based ceramic doped with a nonconductive material and/or a nonconductive aluminum nitride based ceramic doped with a conductive material. In certain embodiments, each semiconductive cap is affixed to the respective electrode with a conductive epoxy. 
     Other aspects and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, illustrating the principles of the invention by way of example only. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The advantages of the invention described above, together with further advantages, may be better understood by referring to the following description taken in conjunction with the accompanying drawings. The drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. 
         FIG. 1  shows a cross-section of a temperature profile in skin for a monopolar copper electrode applied to a skin surface without a semiconductive cap. 
         FIG. 2  shows a cross-section of a temperature profile in skin for bipolar copper electrodes applied to a skin surface without semiconductive caps. 
         FIG. 3  shows a cross-section of a temperature profile in skin when using semiconductive caps on the electrodes. 
         FIG. 4  shows a cross-section of a temperature profile in skin when using semiconductive caps having a variable thickness. 
         FIG. 5  shows a cross-section of another temperature profile in skin when using semiconductive caps with a variable thickness. 
         FIG. 6A  shows a sectional view of an applicator for bipolar RF energy delivered through a skin surface. 
         FIG. 6B  shows a sectional view of a semiconductive cap for an electrode. 
         FIG. 6C  shows a side elevation view of a semiconductive cap for an electrode. 
         FIG. 7A  shows a perspective view of another electrode and semiconductive cap embodiment. 
         FIG. 7B  shows a side view of the embodiment shown in  FIG. 7A . 
         FIG. 8A  shows a cross-section of a temperature profile in skin when using semiconductive caps having an elliptical shape. 
         FIG. 8B  shows temperature of the skin between electrodes. 
     
    
    
     DESCRIPTION OF THE INVENTION 
       FIG. 1  shows a cross-section of a temperature profile in skin for a monopolar copper electrode applied to a skin surface without a semiconductive cap.  FIG. 2  shows a cross-section of a temperature profile in skin for bipolar copper electrodes applied to a skin surface without semiconductive caps. Uneven heat distribution is seen at the edges of the monopolar electrode and is symmetric (equal at both edges). For the bipolar electrodes, the uneven heat distribution is seen at the edges, but is asymmetric. The current density is greater along the inner electrode edges because the pathlength is shorter and hence impedance is lower. More current will travel this path. In both examples, 20 joules of RF energy is delivered to tissue. In general, temperatures greater than 70° C. lead to adverse skin effects such as blisters. 
       FIG. 3  shows a cross-section of a temperature profile in skin when using semiconductive caps (e.g., formed from a ceramic material) on the electrodes. In the figure, the caps are illustrated, but the electrodes are not. The energy delivered to tissue is 20 joules, the same as was used in  FIG. 2 , but because the impedance between the cap and the tissue is better matched, the thermal hotspot is smaller. The hotspots appear on the inner edges due to the shorter electrical pathlength to the next adjacent electrode. High current densities also exist at the edge of the copper electrode-ceramic cap junction. Because of the high thermal conductivity of ceramic, this density does not cause thermal hotspots at this junction. 
       FIG. 4  shows a cross-section of a temperature profile in skin when using semiconductive caps with a variable thickness. In the figure, the caps are illustrated, but the electrodes are not. Because ceramic has finite impedance, it can be shaped to be thicker at the edges to further minimize the thermal hotspot on the inner edges causes by the shorter electrical pathlength. In this case, two times more energy or 40 Joules is delivered to skin, but the thermal hotspots are about half what is seen without the ceramic cap and more importantly less than the 70° C. critical temperature. In this case, the temperature of skin (1 mm deep, halfway between electrodes) is increased to about 42.8° C., an increase of about 10.8 degrees over the starting temperature of about 32° C. Without the ceramic cap, the increase is about 36.2° C. or only about 4.2 degrees above the initial temperature. So with the cap, the skin is more effectively heated with less risk of adverse effects to the skin surface underneath the electrodes. 
       FIG. 5  shows a cross-section of a temperature profile in skin when using semiconductive caps with a variable thickness. In the figure, the caps are illustrated, but the electrodes are not. Each cap has a blunt surface in contact with the skin and a curved surface contacting the electrode. Each cap is asymmetric, being thickest at the inner portion, thinnest at the center portion, and thicker than the center portion but thinner than the inner portion at an outer portion. In the center portion, the cap tapers from thicker than the outer portion to thinner than the outer portion. In this case, 48 Joules of RF energy is delivered, but the thermal hotspots remain under 70° C. The temperature of skin (1 mm deep, halfway between electrodes) is increased to about 40° C. or an increase of about 8° C. Compared with the bare copper electrode, the mid-dermal increase is two times higher while the electrode hotspots are two times lower. In this configuration, a larger volume of tissue is heated compared to the previous configuration so the change in temperature is not as high even through more energy is being delivered to tissue. 
       FIG. 6A  shows an applicator  10  for bipolar RF energy delivered through a skin surface  14 . The applicator  10  includes a base  18 , a first electrode  22  connected to the base  18 , a second electrode  26  connected to the base  18 , a first semiconductive cap  30  disposed on a first distal end  34  of the first electrode  22 , a second semiconductive cap  38  disposed on a second distal  42  end of the second electrode  26 . The first electrode  22  extends from the base  18  toward a first location  46  of the skin surface  14 . The second electrode  26  extends from the base  18  toward a second location  50  of the skin surface  14 . The first electrode  22  is laterally offset along the skin surface  14  from the second electrode  26 , and the first electrode  22  and the second electrode  26  have opposite phases. Each electrode  22  or  26  can be cooled to about 10° C. using a thermoelectric cooler  52  attached to the side of the electrode and or the base  18 . Each electrode  22  or  26  can have separate thermoelectric coolers  52 , which can be water or air cooled. 
     Base  18  can be any member to which the electrodes  22  and  26  are attachable. In some embodiments, base  18  is modular and includes separate members for connection to electrodes  22  and  26 . Base  18  can be a portion or section of a hand piece or applicator, or can be the hand piece or applicator. In some embodiments, base  18  and electrodes  22  and  26  are integrally formed. 
     Each electrode  22  or  26  and/or each semiconductive cap  30  or  38  can have an elliptical shape so that the footprints  46  and  50  of the caps  30  and  38  are elliptical or oval in shape. The treatment region  54  formed by the electrodes  22  and  26  and/or semiconductive caps  30  and  38  can be rectangular in shape, and can extend into the skin surface to a predetermined depth. 
       FIG. 6B  shows a sectional view of a semiconductive cap  30  (or  38 ) for an electrode  22  (or  26 ). In one example, each electrode  22  (or  26 ) and each semiconductive cap  30  (or  38 ) is about 4 mm wide at axis  56  and 12 mm deep at axis  57 . Each electrode  22  or  26  can be about 4 to 15 mm long (e.g., about 12 mm long). The electrodes can be spaced apart by about 5 to 20 mm (e.g., about 12 mm or about 13 mm from inner edge to inner edge). 
     Each electrode  22  or  26  can be an electrically conductive metal (e.g., copper) or ceramic material. Each electrode  22  or  26  can be plated with a nonoxidizing surface such as chrome. Each electrode can be formed from a semiconductive ceramic with an appropriately shaped solder pad. 
       FIG. 6C  shows a side elevation view through axis  56  of a semiconductive cap  30  (or  38 ) for an electrode  22  (or  26 ). The semiconductive cap  30  (or  38 ) has a blunt surface  58  adapted to contact a location of the skin surface  14  (e.g., the first location  46  if it is the first semiconductive cap  30  and the second location  50  if it is the second semiconductive cap  38 ). The semiconductive cap  30  (or  38 ) has a curved surface  60  that can be affixed to the first electrode  22  (or the second electrode  26 ). The thickness of each semiconductive cap  30  (or  38 ) between the blunt surface  58  and the curved surface  60  can be tapered or graded from the inner edge to the outer edge. The semiconductive cap  30  (or  38 ) can be thicker at an inner portion  62  and thinner at a center portion  66  to homogenize the electrical field at the skin surface  14 . An outer portion  70  of the semiconductive cap  30  (or  38 ) can be thicker than the center portion  66  but thinner than the inner portion  62 . In this way, the entrance or exit point for current entering or leaving the electrode is spread across the entire cap surface, which homogenizes the tissue entry current field. The inner edge or portion is the edge/portion adjacent to the next closest electrode. 
     In certain embodiments, along axis  56 , the inner portion  62  is about 2 mm thick, the center portion  66  is about 0.5 mm thick, and the outer portion  70  is about 1 mm. Along axis  57 , the center is about 1 mm thick and the upper and lower edges are about 3 mm thick. 
     Referring back to  FIG. 6A , a source  74  of RF energy is in electrical communication with the base  18  via cable  78 , which can include a single wire or a bundle of wires. Each electrode  22  and  26  includes a separate wire feed  80  and  84 , respectively. Wire feeds  80  and  84  can be in electrical communication with separate wires or feeds of cable  78 . Source  74  can deliver RF energy to and through the skin surface  14 . The source  74  can deliver RF energy via cable  78  to wire feed  80  and  84  to the first electrode  22  and the second electrode  26 , respectively. RF energy can be delivered from the first electrode  22  and the second electrode  26  through the first semiconductive cap  30  and the second semiconductive cap  30 , respectively, through the skin surface  14 . 
     The electrical conductivity of the semiconductive material (e.g., the ceramic material) can be approximate to the electrical conductivity at the tissue-electrode interface. For example, the conductivity of each semiconductive cap can be matched or substantially matched to the conductivity of the skin. The conductivity of each semiconductive cap can be matched so that about 10% of the RF energy is lost to the semiconductive cap. The conductivity of each semiconductive cap can be about 0.1 S/m. The conductivity of the semiconductive caps can be graded such that the central and outer portion are more conductive than the inner portion. 
     If the electrical conductivity is exactly matched, then the current does not concentrate at the ceramic-tissue junction because, from an electrical perspective, no junction exists because of the matched conductivity values. The electrical conductivity for skin is about 0.22 S/m at 1 MHz RF frequency. In this case, the hot spot occurs at the metal electrode-ceramic interface, which, because of the ceramic&#39;s high thermal conductivity, is quickly diffused so that little heating occurs at the skin surface. However, RF energy is lost to the ceramic material and the amount of energy lost is proportional to the electrical conductivity value. In the typical ceramic geometries used, the loss of RF energy to ceramic can be as much as 50%. An electrical conductivity of 0.1 S/m at 1 MHz for the ceramic material can minimize this. Although not exactly matched to skin, the amount of RF energy lost to the ceramic material is around 10% while the thermal hotspot at the electrode edge is greatly diminished compared to when the ceramic material is not used. 
     Each semiconductive cap can include a semiconductive ceramic, which can have an electrical conductivity of about 0.1 S/m. The semiconductive cap can be a passive material in that material properties are independent of temperature. The shape of the cap is made such that the electrical pathlength through the semiconductive cap or ceramic material towards the edges of the electrodes are longer than toward the center. This passively increases the resistance for current flowing towards the edge compared to the center thereby better homogenizing the electric field at the tissue surface. This effectively spreads the current density leaving the probe over a larger area, which reduces the magnitude of the thermal hotspot. 
     Each semiconductive cap can include a conductive silicon carbide based ceramic doped with a nonconductive material and/or a nonconductive aluminum nitride based ceramic doped with a conductive material. The nonconductive material or the conductive material can be used to tune the cap to the desired conductivity. 
     A semiconductive cap can be formed by sintering silicon carbide. The ceramic can be prepared from a green perform, which can allow shaping of the electrode cap to the desired shape and can allow mixing of an additional material to tune the electrical conductivity of the finished product. Boron, aluminum and nitrogen are dopants that can be used to change the electrical conductivity of silicon carbide materials. 
     Each semiconductive cap need not be permanently attached to an electrode. Each semiconductive cap can be affixed, bonded or attached. Each semiconductive cap can be affixed to the respective electrode with a conductive epoxy. A silver conductive epoxy has good thermal and electrical properties, and can bond to metals, glasses and ceramics. 
     Each semiconductive cap can be affixed to the respective electrode with a compressive tongue and groove joint. Each semiconductive cap can be affixed to the respective electrode with a screw passing through the cap and securing to the electrode. A compressive metal gasket can be used to improve thermal and electrical conduction between the cap and the electrode at the junction. 
     The source  74  can provide the RF energy at a frequency of about 100 kHz to about 10 MHz (e.g., about 1 MHz), although higher or lower frequencies can be used depending on the application. The source  74  can include a controller for the RF energy and/or a controller for the thermoelectric cooler  52 . The source can provide the RF energy at about 10 J/cm 3  to about 500 J/cm 3  (e.g., about 50 J/cm 3  to about 120 J/cm 3 ), although higher or lower fluences can be used depending on the application. Using a volumetric heat capacity of 4 J/cm 3 -° C. for skin, 120 J/cm 3  corresponds to a 30° C. rise in skin temperature. The source can provide the RF energy in pulses of about 0.1 second to about 1 second, although shorter or longer durations can be used depending on the application. 
       FIGS. 7A and 7B  show a perspective view and a side view, respectively, of an electrode  22 ′ and semiconductive cap  30 ′, which can be used with base  18  shown in  FIG. 6A . Electrode  22 ′ can have a body portion  88 , a tip  92  and a flange  96 . Tip  92  can extend about 3.5 mm from body  88 , and can be about 9 mm deep and 2 mm wide. Semiconductive cap  30 ′ can define an opening, which is insertable over tip  92 . Semiconductive cap  30 ′ can abut flange  96  and be formed so that its outer surface is flush with the outer surface of the body portion  88  of the electrode  22 ′. Each semiconductive cap  30 ′ can be permanently or semi-permanently attached to an electrode. 
     Cap  30 ′ can have a variable thickness, e.g., a thickness between the blunt surface and the curved surface is thicker at an inner portion and thinner at a center portion to homogenize the electrical field at the skin surface. The variable thickness of cap  30 ′ is symmetric. The cap  30 ′ can be about 0.5 mm thick at the center and about 4.0 mm thick around its perimeter. The cap  30 ′ can about 12 mm deep and 4 mm wide. The thickness of the wall surrounding the opening is about 1 mm in the x-plane and about 1.5 mm in the y-plane. 
       FIG. 8A  shows a cross-section of a temperature profile in skin when using semiconductive caps with a variable thickness. In the figure, a cap is illustrated, but the electrode is not. Each cap has a blunt surface in contact with the skin and a curved surface contacting the electrode. Each cap is elliptical or oval in shape. In this case, the hot zone around the edge is evenly distributed, with peak temperatures reaching about 69° C. (e.g., thermal hotspots remaining under 70° C.).  FIG. 8B  shows temperature of the skin between electrodes, with the temperature reaching a maximum about 2 mm from the electrode edge. In this configuration, a larger volume of tissue is heated compared to the previous configurations so the change in temperature is not as high even through more energy is being delivered to tissue. 
     While the invention has been particularly shown and described with reference to specific illustrative embodiments, it should be understood that various changes in form and detail may be made without departing from the spirit and scope of the invention.