Needle array devices and related methods

Abstract

A system and method for performing treatments, such as acne treatments and other cosmetic treatments, using contact technology is provided. In part, the present disclosure relates to a method for treating acne and / or excessive sweating and / or unwanted hair and / or unwanted blood vessels, which may include providing a needle array having a plurality of needles, inserting the plurality of needles into the dermis of a treatment site, locating an enlarged sebaceous gland, and energizing at least one of the plurality of needles to treat the sebaceous gland and / or one or more sweat glands and / or vascular lesions and / or unwanted hair follicles and / or unwanted blood vessels.

Description

Related Applications

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 020,461, filed May 5, 2020, the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] Treatment of acne is a major problem for dermatologists, with millions of people visiting dermatologists each year. While acne typically develops in the early teens and resolves by the mid-twenties, in many cases, especially in women, it remains a chronic problem that persists into adulthood.

[0003] Acne vulgaris, the most common form of acne, occurs when sebum secreted by sebaceous glands blocks pores. Continued secretion causes sebum to accumulate in the blocked pores. Bacteria in the pores can cause infection, resulting in the commonly unsightly skin condition known as a pimple. Sebaceous hyperplasia is another common type of acne that occurs when sebaceous glands produce too much sebum, causing them to grow or enlarge. Summary of the Invention [Problem to be solved by the invention]

[0004] Traditional acne treatments involve the destruction of sebaceous glands using radiation therapy. However, because radiation does not specifically target sebaceous glands, it can cause significant pathology in normal tissues through mutagenic toxicity. An increased risk of skin cancer is also associated with radiation therapy. Many acne treatments are unsatisfactory, being non-curative because they do not selectively eliminate sebaceous glands and also adversely affect surrounding normal tissues. This results in lengthy treatments lasting many years and can lead to scarring for patients.

[0005] The present disclosure relates to systems and methods that address some or all of the above, as well as systems and methods for treating acne and other cosmetic treatments using contact-based technology. [Means for solving the problem]

[0006] In particular, the systems and methods described herein treat tissues of the human body. As a specific example, the systems and methods described below treat skin conditions caused by hair follicles becoming clogged with oil and dead skin cells, affecting various parts of the body, including the face, neck, and other areas traditionally prone to acne vulgaris.

[0007] In addition, in part, the present disclosure relates to systems and methods for identifying sebaceous glands on the face or other tissue regions using tissue characterization circuitry and for targeting the sebaceous glands to treat or prevent acne using a handheld applicator. In various embodiments, a microneedle array is used, which includes needles arranged in a regular pattern, such as a hexagon or other regular polygon, with a needle at each vertex and at the center (or between the vertices). These needles are sometimes referred to as electrodes. That is, a microneedle array can also be an array of electrodes.

[0008] In part, the present disclosure relates to a method for treating acne, comprising providing a needle array having a plurality of needles, inserting the plurality of needles into the dermis at a treatment site, locating an enlarged sebaceous gland, and energizing at least one of the plurality of needles to treat the enlarged sebaceous gland.

[0009] In one embodiment, the diameter of the enlarged sebaceous gland is greater than about 50 μm. In one embodiment, the detecting step includes delivering a low-power pulse from each of the plurality of needles, collecting impedance data for each of the plurality of needles, and determining which of the plurality of needles is in proximity to the enlarged sebaceous gland based on the collected impedance data. In one embodiment, the low-power pulse is a series of low-power pulses that are repeatedly delivered until the collected impedance data exhibits a contrast indicative of the presence or absence of an enlarged sebaceous gland.

[0010] In one embodiment, the energizing step includes delivering energy to a needle of the plurality of needles positioned proximate the enlarged sebaceous gland. In one embodiment, at least one needle has a liquid outlet and a flow path for receiving a solution. In one embodiment, the solution is a conductive solution.

[0011] In one embodiment, the method further comprises designating at least one needle of the plurality of needles according to an energization scheme, such as a multiplexing scheme. In one embodiment, the plurality of needles are arranged in hexagonal needle clusters with one needle within each cluster. In one embodiment, normal-sized sebaceous glands are excluded from the energy exposure.

[0012] In one embodiment, detecting the location of enlarged sebaceous glands further comprises performing impedance mapping on the treatment area. In one embodiment, detecting the location of enlarged sebaceous glands further comprises identifying the enlarged sebaceous glands according to one or more impedance measurements obtained from the impedance mapping. In one embodiment, detecting the location of enlarged sebaceous glands further comprises measuring an impedance difference between two adjacent needles across the sebaceous glands. In one embodiment, the method further comprises performing a diagnostic impedance measurement on the treatment area. In one embodiment, the method further comprises excluding high and / or low impedance values ​​from the diagnostic measurement.

[0013] In part, the present disclosure relates to a method for treating excessive sweating, comprising providing a needle array having a plurality of needles, inserting the plurality of needles subcutaneously into a treatment area, locating one or more sweat glands, and energizing at least one of the plurality of needles to treat the one or more sweat glands.

[0014] In one embodiment, the detecting step includes delivering a low-power pulse from each of the plurality of needles, collecting impedance data for each of the plurality of needles, and determining which of the plurality of needles is in proximity to the one or more sweat glands based on the collected impedance data. In one embodiment, the low-power pulse is a series of low-power pulses that are delivered repeatedly until the collected impedance data exhibits a contrast indicative of the presence or absence of one or more sweat glands.

[0015] In one embodiment, the energizing step includes delivering energy through a needle of the plurality of needles located near the one or more sweat glands. In one embodiment, at least one needle has a liquid outlet and a flow path for receiving a solution. In one embodiment, the solution is a conductive solution.

[0016] In one embodiment, the method further comprises designating at least one needle of the plurality of needles according to an energization scheme, such as a multiplexing scheme. In one embodiment, the plurality of needles are arranged in hexagonal needle clusters with one needle within each cluster. In one embodiment, a portion of the one or more sweat glands are excluded from energy exposure.

[0017] In one embodiment, detecting the location of one or more sweat glands further comprises performing impedance mapping on the treatment area. In one embodiment, detecting the location of one or more sweat glands further comprises identifying the one or more sweat glands according to one or more impedance measurements obtained from the impedance mapping. In one embodiment, detecting the location of one or more sweat glands further comprises measuring an impedance difference between two adjacent needles that straddle the one or more sweat glands. In one embodiment, the method further comprises performing a diagnostic impedance measurement on the treatment area. In one embodiment, the method further comprises excluding high impedance values ​​and / or low impedance values ​​from the diagnostic measurement.

[0018] In part, the present disclosure relates to a method for treating unwanted hair, comprising providing a needle array having a plurality of needles, inserting the plurality of needles into the dermis of a treatment site containing unwanted hair, locating a hair shaft of an unwanted hair follicle, and energizing at least one of the plurality of needles to treat the unwanted hair follicle.

[0019] In one embodiment, the detecting step includes delivering a low-power pulse from each of the plurality of needles, collecting impedance data for each of the plurality of needles, and determining which of the plurality of needles is in proximity to an unwanted hair shaft based on the collected impedance data. In one embodiment, the low-power pulse is a series of low-power pulses that are repeatedly delivered until the collected impedance data exhibits a contrast indicative of the presence or absence of an unwanted hair shaft.

[0020] In one embodiment, the energizing step includes delivering energy from a needle of the plurality of needles positioned proximate the unwanted hair follicle. In one embodiment, at least one needle has a liquid outlet and a flow path for receiving a solution. In one embodiment, the solution is a conductive solution.

[0021] In one embodiment, the method further comprises designating at least one needle of the plurality of needles according to an energization scheme, such as a multiplexing scheme. In one embodiment, the plurality of needles are arranged in hexagonal needle clusters with one needle within each cluster.

[0022] In one embodiment, detecting the location of unwanted hairs further comprises performing impedance mapping of hair shafts of unwanted hair follicles. In one embodiment, detecting unwanted hairs further comprises identifying the unwanted hair shafts according to one or more impedance measurements obtained from the impedance mapping. In one embodiment, detecting the location of unwanted hairs further comprises measuring an impedance difference between two adjacent needles that span the unwanted hair shafts. In one embodiment, the method further comprises performing a diagnostic impedance measurement on the treatment area. In one embodiment, the method further comprises excluding high and / or low impedance values ​​from the diagnostic measurement.

[0023] In part, the present disclosure relates to a method for treating a vascular lesion, the method comprising the steps of providing a needle array having a plurality of needles, inserting the plurality of needles into the dermis at a treatment site, locating one or more blood vessels (e.g., unwanted blood vessels), and energizing at least one of the plurality of needles to treat the one or more blood vessels (e.g., one or more of the unwanted blood vessels).

[0024] In one embodiment, the detecting step further includes delivering a low-energy power pulse from each of the plurality of needles, collecting impedance data for each of the plurality of needles, and determining which of the plurality of needles is near the one or more blood vessels based on the collected impedance data. In one embodiment, the low-power pulse is a series of low-power pulses that are repeatedly delivered until the collected impedance data exhibits a contrast indicating the presence or absence of one or more blood vessels. In one embodiment, the energizing step includes delivering energy from a needle of the plurality of needles that is located near the one or more blood vessels. In one embodiment, at least one needle has a liquid delivery port and a flow path for receiving a solution. In one embodiment, the solution is a conductive solution.

[0025] In one embodiment, the method further comprises designating at least one needle of the plurality of needles according to an energization scheme, such as a multiplexing scheme. In one embodiment, the plurality of needles are arranged in hexagonal needle clusters with one needle within each cluster. In one embodiment, regions containing one or more blood vessels with normal blood concentrations are excluded from energy exposure. In one embodiment, locating the one or more blood vessels further comprises performing impedance mapping of the treatment area. In one embodiment, locating the one or more blood vessels further comprises identifying one or more enlarged blood vessels according to one or more impedance measurements obtained from the impedance mapping.

[0026] In one embodiment, detecting the location of one or more blood vessels further includes identifying one or more elevated blood volume fractions in response to one or more impedance measurements obtained from the impedance mapping. In one embodiment, detecting the location of one or more blood vessels further includes measuring an impedance difference between two adjacent needles spanning the one or more blood vessels. In one embodiment, detecting the location of one or more regions of elevated blood volume fraction further includes measuring an impedance difference between two adjacent needles spanning the one or more regions of elevated blood volume fraction. In one embodiment, the method further includes performing a diagnostic impedance measurement on the treatment site. In one embodiment, the method further includes excluding high impedance values ​​and / or low impedance values ​​from the diagnostic measurement. In some embodiments, some blood vessels detected in the impedance mapping are intentionally not treated, while the remaining detected blood vessels are treated with RF power by energizing at least one of the needles. This is because it is assumed or understood that one or more blood vessels are being treated because they are one or more vascular lesions that are visible from the outside, and it is expected that treating these one or more specific blood vessels will improve the appearance of those one or more vascular lesions.

[0027] In part, the present disclosure relates to a method of treating tissue, comprising providing a needle array having a plurality of needles, inserting the plurality of needles into one or more tissue layers at a treatment site, detecting the location of a tissue object, and energizing at least one of the plurality of needles to perform a cosmetic treatment on one or more portions of the tissue object.

[0028] In one embodiment, the tissue target is selected from the group including one or more of a hair follicle, a sweat gland, a blood vessel, a vascular lesion, and a sebaceous gland. In one embodiment, detecting the location of the tissue target further includes delivering a low-power pulse from each of the plurality of needles, collecting impedance data for each of the plurality of needles, and determining which of the plurality of needles is proximate to the tissue target based on the collected impedance data. In one embodiment, detecting the location of the tissue target further includes performing impedance mapping for the treatment site.

[0029] While the present disclosure relates to various aspects and embodiments, it should be understood that the various aspects and embodiments disclosed herein may be integrated, combined, or used together as an integrated system, or as separate components, devices, or systems, as appropriate. That is, any implementation may incorporate any of the embodiments disclosed herein to any extent, as appropriate. Furthermore, the various systems, probes, applicators, needle arrays, controllers, components, and parts described above may be used with any other devices or systems, on any suitable tissue surface, for cosmetic, aesthetic, medical, or other applications.

[0030] These and other aspects of the applicant's teachings are described herein. [Brief explanation of the drawings]

[0031] [Figure 1A] FIG. 1 is a schematic diagram illustrating the application of a needle array to tissue to identify and treat specific classes of tissue or organ structures, such as enlarged sebaceous glands, in an exemplary embodiment of the present disclosure. [Figure 1B] FIG. 10 is another schematic diagram illustrating the application of a needle array to tissue to identify and treat specific classes of tissue or organ structures, such as enlarged sebaceous glands, in an exemplary embodiment of the present disclosure. [Figure 2A]FIG. 10 is yet another schematic diagram illustrating the application of a needle array to tissue to identify and treat specific classes of tissue or organ structures, such as enlarged sebaceous glands, in an exemplary embodiment of the present disclosure. [Figure 2B] FIG. 10 is yet another schematic diagram illustrating the application of a needle array to tissue to identify and treat specific classes of tissue or organ structures, such as enlarged sebaceous glands, in an exemplary embodiment of the present disclosure. [Figure 3] 1 is a graph showing the impedance characteristic ratio of fat to wet skin, specifically the ratio of the impedance amplitude of fat to the impedance amplitude of wet skin (solid line) and the ratio of the impedance phase angle of fat to the impedance phase angle of wet skin (dashed line), over a frequency range of about 0.0001 MHz to about 1000 MHz (e.g., about 100 Hz to about 1 GHz, etc.), in an exemplary embodiment of the present disclosure. [Figure 4] 1 is a graph showing four curves of the permittivity and conductivity of blood versus wet skin (a surrogate for dermal tissue) over a frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz, etc.) in an exemplary embodiment of the present disclosure. [Figure 5] 1 is a graph showing two curves of the specific impedance amplitude of blood versus wet skin (a surrogate for dermal tissue) over a frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz, etc.) in an exemplary embodiment of the present disclosure. [Figure 6] 1 is a graph showing two curves of the phase angle of blood versus wet skin (a surrogate for dermal tissue) over a frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz, etc.) in an exemplary embodiment of the present disclosure. [Figure 7] 1 is a graph showing two curves of the impedance amplitude ratio and impedance phase angle ratio of blood to wet skin (a surrogate for dermal tissue) over a frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz, etc.) in an exemplary embodiment of the present disclosure. [Figure 8] FIG. 1 is a schematic diagram illustrating an example of an RF electrode needle having a liquid delivery port around its circumference in accordance with an exemplary embodiment of the present disclosure. [Figure 9] FIG. 1 is a schematic diagram illustrating an example of RF electrode needles with liquid delivery ports mounted in a hexagonal pattern on an electrode applicator holder in an exemplary embodiment of the present disclosure. [Figure 10] FIG. 1 is a schematic cross-sectional view illustrating an example of an RF electrode needle with a liquid delivery port mounted in a hexagonal pattern on an electrode applicator holder in an exemplary embodiment of the present disclosure. [Figure 11] FIG. 1 is a schematic diagram illustrating an example of an RF electrode needle having liquid delivery ports around its circumference and at its tip, according to an exemplary embodiment of the present disclosure. [Figure 12] FIG. 10 is a schematic diagram illustrating an example of an RF electrode needle without a liquid delivery port in accordance with an exemplary embodiment of the present disclosure. [Figure 13] FIG. 1 is a schematic diagram illustrating an example of an RF electrode needle having a liquid delivery port at its tip in accordance with an exemplary embodiment of the present disclosure. [Figure 14] FIG. 1 is a schematic diagram illustrating an example of an RF electrode needle mounted on an electrode holder, allowing the electrode applicator holder with the electrode to be removed from the handpiece, in an exemplary embodiment of the present disclosure. [Figure 15]1 is a graph showing the dielectric properties, including permittivity and conductivity, of wet skin (a surrogate for dermal tissue) and fat (a surrogate for sebaceous tissue) over the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz, etc.). (All data source: Gabriel S, Lau RW, and Gabriel C, "The dielectric properties of biological tissues: III. Parametric models for the dielectric spectrum of tissues." Physics in Medicine & Biology. 1996 Nov; 41(11):2271 and Gabriel C, Peyman A, and Grant EH, "Electrical conductivity of tissue at frequencies below 1 MHz." Physics in medicine & biology. 2009 Jul 27;54(16):4863.) [Figure 16] 1 is a graph showing the ratio of the dielectric properties of fat (a surrogate for sebaceous glands) to wet skin (a surrogate for dermal tissue) over the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz), specifically, the ratio of the conductivity of fat to the conductivity of wet skin (solid line) and the ratio of the permittivity of fat to the permittivity of wet skin (dashed line). [Figure 17] 1 is a graph of the specific electrical impedance amplitude of wet skin (a surrogate for dermal tissue) (solid line) and fat (a surrogate for sebaceous tissue) (dashed line) over a frequency range of about 0.0001 MHz to about 1000 MHz (e.g., about 100 Hz to about 1 GHz, etc.) in an exemplary embodiment of the present disclosure. [Figure 18] 1 is a graph showing the specific impedance phase angle of wet skin (a surrogate for dermal tissue) (solid line) and fat (a surrogate for sebaceous tissue) (dashed line) over a frequency range of about 0.0001 MHz to about 1000 MHz (e.g., about 100 Hz to about 1 GHz, etc.) in an exemplary embodiment of the present disclosure. [Figure 19] 1 is a graph showing, with four curves, the relative permittivity and conductivity of fat and the relative permittivity and conductivity of artificial sweat at frequencies in a frequency range of approximately 0.0001 MHz to approximately 1000 MHz (e.g., 100 Hz to 1 GHz, etc.) in an exemplary embodiment of the present disclosure. [Figure 20] 1 is a graph showing two curves of sweat-to-fat specific impedance amplitude over a frequency range of approximately 0.0001 MHz to approximately 1000 MHz (eg, 100 Hz to 1 GHz, etc.) in an exemplary embodiment of the present disclosure. [Figure 21] 1 is a graph showing two curves of sweat-to-fat phase angles over a frequency range of approximately 0.0001 MHz to approximately 1000 MHz (eg, 100 Hz to 1 GHz, etc.) in an exemplary embodiment of the present disclosure. [Figure 22] 1 is a graph showing two curves of sweat-to-fat impedance amplitude ratio and impedance phase angle ratio over a frequency range of approximately 0.0001 MHz to approximately 1000 MHz (e.g., 100 Hz to 1 GHz, etc.) in an exemplary embodiment of the present disclosure. [Figure 23] FIG. 1 is a block diagram that schematically illustrates a temperature-controllable circuit topology for an RF-based system in accordance with an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0032] This disclosure describes devices and methods for delivering energy to sebaceous glands to treat acne and / or identify specific types of sebaceous glands to treat. Sebaceous glands are located in the dermis of the skin. Sebaceous glands are distributed throughout the body, except for the palms of the hands and soles of the feet, with the greatest abundance on the scalp and face. Sebaceous glands produce and release sebum, a lipid substance, to help protect and lubricate the skin surface. Sebum is composed of lipids, cellular debris, and keratin. Acne is typically associated with enlarged sebaceous glands, often due to blockage of the sebaceous gland's exit to the skin surface, resulting in sebum accumulation within hair follicles. RF energy is delivered to a treatment device containing a needle array, which activates the needles to deliver RF treatment energy to tissue, specifically to targeted structures within the tissue, such as enlarged sebaceous glands. Sebaceous glands help maintain moisture and lubrication in the skin and hair. Some research also suggests that sebaceous glands contribute to immune system function. Therefore, it is important that acne treatments that focus on treating enlarged sebaceous glands avoid treating normal sebaceous glands, which perform and support important functions of the skin and, in some cases, the immune system.

[0033] In one embodiment, the treatment is performed across the tissue region between a pair of needle electrodes. The array can be integrated into at least one handpiece or applicator. In some embodiments, the array is a detachable consumable item, such as a detachable needle array.

[0034] Suitable microneedle puncture systems may have power delivery levels within the range of about 1 milliwatt to about 10 kilowatts or about 100 milliwatts to 100 watts. Such microneedle puncture systems may deliver RF energy for a time period of about 1 nanosecond to about 10 seconds, about 1 microsecond to about 1 second, or about 1 millisecond to about 500 milliseconds.

[0035] A suitable microneedle puncture system includes microneedle puncture electrodes, also referred to as electrodes and / or needle electrodes. These may be uninsulated, insulated, or nearly insulated, with only the tip uninsulated. This allows RF energy to be delivered to the target depth within the tissue at the tip. The target depth of the needle electrodes may vary based on the target tissue. For example, sebaceous glands are located approximately 1-2 mm below the skin surface, while sweat glands are located below the dermal / subcutaneous junction, which may be within a range of approximately 2-5 mm below the skin surface. The diameter of each needle electrode may range from approximately 100 to approximately 1000 micrometers, more preferably from approximately 200 to approximately 600 micrometers. The desire for a relatively small needle diameter to prevent stinging / pain upon penetration into the skin surface must be balanced against the need to maintain the electrode's straightness / non-bending during repeated use. Future material advances may result in even smaller diameter electrodes that meet this need.

[0036] In various embodiments, treatment is carried out over several treatment sessions to reduce and / or damage and / or destroy one or more enlarged sebaceous glands. The reduction, damage, destruction, or destruction of the glands and / or exposure to RF energy alleviates the symptoms of acne vulgaris and sebaceous hyperplasia. Furthermore, in various embodiments, RF energy is applied in a controlled amount and / or in a time-varying pattern (e.g., multiplexed delivery from each needle cluster) to disrupt sebum production in the sebaceous glands. Over several treatment sessions, enlarged sebaceous glands may be restricted, controlled, or modified to reduce or cease sebum production compared to their pre-treatment state. In some embodiments, an initial treatment regimen may be followed by occasional treatments to prevent, mitigate, or modify the development and / or progression of acne.

[0037] Typically, sebum provides skin with moisture and lubrication, and is thought to also function as the skin's immune barrier. However, in some cases, one or more sebaceous glands may become enlarged and produce too much sebum. Without being bound by any particular theory or mechanism, acne vulgaris appears to develop in response to alterations (e.g., increases) in sebaceous gland secretion and / or sebum flow to the skin surface. Generally speaking, increased sebum production by sebaceous glands and / or restricted or obstructed sebum flow lead to the typical symptoms of acne vulgaris and sebaceous hyperplasia.

[0038] Other energy-based treatments for acne vulgaris involve devices that deliver energy to the affected area. However, these devices typically cannot locate sebaceous glands in the dermis without additional devices. Generally, various imaging techniques can be used separately to locate sebaceous glands, including confocal microscopy, optical coherence tomography, multiphoton microscopy, and other similar techniques that take into account the scattering properties of the human dermis. Typically, these imaging techniques are followed by targeted energy delivery, which removes most of the epidermis and dermis and damages the sebaceous glands, minimizing damage to surrounding tissue. These techniques can also be used in conjunction with one or more embodiments disclosed herein and may benefit from the synergy of the needle arrays and treatment modes disclosed herein.

[0039] In various embodiments, the present disclosure describes methods and systems for detecting and targeting sebaceous glands, followed by delivery of RF energy configured to treat the sebaceous glands in the target area. In various embodiments, the RF energy diagnostic delivery device includes an array of electrodes, also referred to as needles or microneedles. FIGS. 1A and 1B are schematic diagrams illustrating the application of a needle array (also referred to as a microneedle array or an array of electrodes) 5 to tissue to identify and treat specific types of tissue or organ structures, such as enlarged sebaceous glands. As shown, FIGS. 1A and 1B schematically depict a needle array of individual needles N. Each needle N is in electrical communication with a control system and an energy delivery system. In various embodiments, each needle is an electrode. In various embodiments, RF energy can be generated in pairs between at least one pair of two needles, or between at least one needle and an indifferent electrode pad attached to the patient's body.

[0040] The needle array 5 may include clusters of needles, i.e., one or more subarrays of needles, arranged in various patterns. These needles are brought into contact with tissue containing sebaceous glands (SG) and enlarged sebaceous glands (ESG). Normal sebaceous glands (SG) measure approximately 50 μm or less in diameter. Enlarged sebaceous glands (ESG) measure greater than 100 μm, e.g., 100 μm to 1 mm, or 100 μm to 5 mm in diameter. Clusters C1 and C2 are marked in FIG. 1A and cluster C2 in FIG. 1B as individual hexagonal clusters or subarrays, each with six needles at the apex and one at the center. Needles N1 and N2 within cluster C2 are marked in association with enlarged sebaceous glands (ESG). In FIGS. 2A and 2B, hexagonal clusters C3 and C4 are marked along with the needle array 10, each with a needle N.

[0041] Arranging needle clusters in a hexagonal pattern advantageously provides a regular arrangement that maximizes the number of nearest equidistant electrodes for any electrode (six in this example). A needle array with electrodes and needles (e.g., microneedles) arranged in a hexagonal cluster or arrangement can be used to identify sebaceous glands within the skin. The dermis and the lipid sebum have different impedances, with the dermis impedance being similar to that of wet skin, and the sebum impedance being similar to that of adipose tissue. Thus, diagnostic scanning of the needle grid identifies adjacent pairs of needles with high sebum concentrations in the intervening space (enlarged sebaceous glands). For example, in Figures 1A and 2A, the scanning process distinguishes between the SG and ESG. Then, as shown in Figures 1B and 2B, the ESG is treated with RF. In Figure 2B, two ESGs are treated simultaneously.

[0042] When scanning a normal sebaceous gland, e.g., a gland with a diameter of about 50 μm or less, the differential impedance measurements between two adjacent needles straddling the same gland tend to exhibit minimal impedance differences or to fall within the low impedance difference range characteristic of normal (i.e., non-enlarged) sebaceous glands or the absence of sebaceous glands within the scanned area. The edge-to-edge spacing of the microneedles within the array can vary from about 100 μm to about 3 mm, from about 100 μm to about 1 mm, or from about 200 μm to about 500 μm.

[0043] Larger sebaceous glands (e.g., ESG) exhibit greater impedance variability from a baseline measurement. Smaller sebaceous glands (SG) exhibit smaller impedance variability from a baseline. The baseline may be defined as the average impedance measurement for a group of electrodes, excluding outliers (e.g., high impedance, low impedance, etc.). For a given treatment session, a microneedle array is inserted into a tissue site. The array may be detachably or directly connected to a reusable or disposable handpiece. A diagnostic scan of the tissue site measures the impedance of each electrode or between each pair of electrodes. High and / or low impedance values ​​are excluded from the diagnostic measurement, and then a baseline impedance for the particular tissue site is determined. In one embodiment, if a high and / or low impedance value is determined, the microneedle or microneedle pair associated with the high and / or low impedance value is reserved for subsequent treatment. In other embodiments, after the baseline impedance is determined, the system again references high and / or low impedance values ​​to determine which impedance values ​​to investigate for treatment purposes based, for example, on the current frequency of the system.

[0044] The edge-to-edge spacing of the microneedles in the array can vary from about 100 μm to about 1 mm, or from about 200 μm to about 500 μm. For example, a diagnostic system can be designed to identify the presence or absence of enlarged sebaceous glands (ESG) based on the contrast in impedance amplitude ratios observed at about 0.01 MHz to about 1000 MHz, about 0.03 MHz to about 500 MHz, and about 1 MHz to about 10 MHz in Figure 3.

[0045] In other embodiments, the array may be configured in a shape other than a hexagon, including, but not limited to, a rectangle, a pentagon, an octagon, a circle, or other geometric shapes. Just prior to treatment, the array of electrodes or microneedles is inserted into the treatment area on the skin. Figures 1A and 1B and 2A and 2B depict each array 5, 10 in contact with tissue during a treatment session.

[0046] In various embodiments, after proper placement of an electrode array (e.g., a needle array, a microneedle array, etc.), the subject's sebaceous glands are treated in a two-step process. First, in at least one example, a low-energy diagnostic pulse is applied to the needle array. The location of each sebaceous gland is determined based on the difference in dielectric properties between sebum and the skin dermis. A control system energizes the needle array in either a monopolar or bipolar manner. In a monopolar diagnostic process, the impedance between each electrode of the needle array and a neutral return electrode identifies the electrode inserted into the sebaceous gland. In some cases, needles of the needle array may accidentally be inserted into a sebaceous gland. In a bipolar diagnostic process, the location of sebaceous glands located between the electrodes of the array is calculated based on pairwise or groupwise impedance measurements between two, three, or four or more electrodes. In various embodiments, the control system sequentially energizes each group of two, three, four or more electrodes to map each sebaceous gland within the treatment area formed by the needles of the needle array.

[0047] The diagnostic process concludes by identifying some of the electrodes in the needle array that happen to be directly inserted into a sebaceous gland and the nearest electrode pair (or group of electrodes consisting of one or more pairs of electrodes) surrounding another sebaceous gland. In various embodiments, the location and approximate size of the sebaceous gland are determined by the impedance variation. The impedance variation caused by a sebaceous gland surrounded by a group of two or more electrodes increases with the size of the sebaceous gland, compared to the needle array average of impedance measurements between similar electrodes in the absence of the sebaceous gland.

[0048] In one embodiment, selected pairs of adjacent needles, such as needle pairs N1 and N2 in FIGS. 1A and 1B and needle pairs N3, N4, N5, and N6 in FIGS. 2A and 2B, are energized to treat enlarged sebaceous glands ESG with RF energy. These pairs may be selected based on the ESG with the highest lipid concentration determined during the diagnostic procedure. Treatment is then performed using a treatment technique. Specifically, these needle pairs may be energized for a time approximately equal to the thermal relaxation time of the tissue between each pair of needles, as shown in FIGS. 1B and 2B. The RF delivered results in selective RF heating. Depending on the treatment session, high power / output may be required for a short period of time for selective RF heating.

[0049] In one embodiment, energizing the array is selectively performed to manage or alleviate pain. Energizing a select subset of needles simultaneously for short periods can reduce associated pain. While maintaining the same energy delivery rate, applying shorter rather than longer pulses at therapeutic levels may reduce perceived pain. Alternatively, selective energizing the array to treat one or a few ESGs at a time can also manage or alleviate pain. Cooling or other techniques may also be used. In various embodiments, the needle array is implemented as a handpiece or applicator that can be used with one or more umbilicals and one or more associated treatment systems. Epidermal cooling may be used to distract the patient for pain management.

[0050] In various embodiments, the size of the localized sebaceous glands is estimated from the impedance variation. Typically, the diameter of an uninflamed sebaceous gland is approximately 50 μm or less. However, various conditions can disrupt sebaceous gland output, leading to enlargement and inflammation, potentially reaching diameters of 1 millimeter or more. Larger sebaceous glands exhibit larger impedance variations from baseline. Smaller glands exhibit smaller impedance variations from baseline. The baseline may be defined as the average impedance measurement of the electrodes, excluding outliers (e.g., high impedance, low impedance, etc.). In various embodiments, the control system selects the most enlarged sebaceous gland ESG for energy delivery. A cutoff ESG that is 50%, 2x, 3x, 4x, or 5x larger than a normal-sized SG may be defined as treatment target. Normal-sized and small sebaceous glands may be ignored (left intact) due to their low impedance contrast. Treatment may be selected in a round-robin fashion, from largest to smallest ESGs, based on available RF power and pain sensitivity, or all ESGs may be treated with a single short pulse. In either case, the control system selects ESGs to be treated so that each treated area is surrounded by untreated areas.

[0051] In various embodiments, the diagnostic process may be performed in a frequency range where the dynamic change in the specific impedance of the sebaceous gland upon heating is significant. For example, in one embodiment, the diagnostic process begins at a frequency where the specific impedance of the epidermis differs from that of the sebaceous gland by approximately two-fold or more. The diagnostic process then proceeds in two stages. In the first stage, a diagnostic pulse of intermediate power is applied between groups of diagnostic electrodes. The intermediate power of the diagnostic pulse is selected to induce the intended dynamic change in the specific impedance without causing undesirable heating effects, such as skin coagulation. The diagnostic intermediate power is selected so that the change in the specific impedance of the sebaceous gland due to the intermediate power RF heating is much larger than the change in the specific impedance of the surrounding dermis. In the second stage (which may be performed in parallel with the first stage), impedance-based localization is performed based on the fact that the change in the impedance of the dermis due to the intermediate power RF heating is much smaller than the dynamic change in impedance observed at the sebaceous gland. The diagnostic power level may vary from about 1 nanowatt to about 10 watts. The preferred power levels are determined with an exemplary assembly and are based on testing with real tissue, including the parasitic impedance of the assembly.

[0052] In other embodiments, the diagnostic process can be performed by sweeping the diagnostic frequency over a range in which the specific impedance of the sebaceous gland and / or dermis and / or the ratio of the specific impedances change rapidly as the diagnostic frequency is changed. This diagnostic technique can be particularly advantageous when the parasitic impedance of the diagnostic system, including the electrodes, produces data with a low signal-to-noise ratio. For example, based on the specific impedance phase angle ratio plotted in FIG. 3 (i.e., the ratio of the impedance amplitude of fat to the impedance phase angle of wet skin (dashed line)), the frequency range from about 1 kHz to about 1 MHz represents the range in which the ratio of the specific impedance phase angle changes rapidly. In various embodiments, the optimal frequency for determining the location of sebaceous glands is one that allows for contrast between the specific impedance of the sebaceous gland and the specific impedance of the surrounding dermis (in this example, fat is used as a proxy for sebaceous tissue, and wet skin is used as a proxy for dermal tissue).

[0053] In various embodiments, after the location of the target sebaceous gland is identified, the control system delivers a high-power treatment pulse suitable for treatment rather than detection / diagnosis to each electrode identified as being within or near the target sebaceous gland (e.g., an enlarged sebaceous gland, etc.). In most cases, only a relatively small percentage of the electrodes in the needle array will be near the target sebaceous gland, resulting in only a small portion of the dermis near the target sebaceous gland experiencing thermal damage.

[0054] In various embodiments, RF power levels during a treatment session can vary from about 0.001 Watts to about 1000 Watts. Preferred power levels are determined using a tester and based on actual tissue testing, including the tester's parasitic impedance. For example, preferred treatment power levels using a tester can be determined by testing a series of skin tissue sections with treatments corresponding to various power levels. Each skin tissue section can then be evaluated for disruption of enlarged sebaceous glands. This evaluation can also include ensuring that normal-sized sebaceous glands are not damaged. The power level for a given treatment session can be set by the power level associated with a tissue section in which large sebaceous glands are disrupted / damaged but normal-sized glands are not damaged.

[0055] In some embodiments, the portion of energy that reaches the dermis provides additional benefits, such as collagen remodeling and skin tightening. In various embodiments, the control system preferentially energizes electrodes with the largest impedance difference, thereby repairing thermally damaged tissue areas without undesirable side effects. The control system may select ESGs to treat such that each treated area is surrounded by untreated areas. Such non-uniform or adaptive "spot" treatment speeds tissue repair.

[0056] In various embodiments, the treatment frequency may be optimally selected so that the impedance of the targeted sebaceous gland is lower than that of the surrounding dermis, so that the sebaceous gland heats more efficiently and reaches a higher temperature than the surrounding dermis. For example, the temperature of the targeted sebaceous gland during treatment may be expected to be greater than about 45°C.

[0057] In other embodiments, the treatment frequency can be selected so that the impedance of the sebaceous gland is similar to or higher than the surrounding dermis. Even in this situation, the sebaceous gland can be heated to a higher temperature than the surrounding dermis due to its low heat capacity and low thermal conductivity. Alternatively, the treatment frequency can be selected so that the impedance of the sebaceous gland is similar to or higher than the surrounding dermis. In this case, the sebaceous gland is heated by thermal diffusion from the surrounding dermis, which is heated more efficiently. By limiting thermal damage to the dermis to only the area containing the ESG between the segmented RF electrodes, the thermally damaged dermal area can be quickly restored after treatment. Within the range of frequency data for fat and wet skin, the impedance of fat is higher than the impedance of wet skin at approximately 100 Hz to approximately 1 GHz. This corresponds to the case where the dermis has a higher heat generation efficiency and the sebaceous gland is heated by thermal diffusion from the surrounding dermis.

[0058] When the RF frequency is selected to heat the ESG more efficiently than the dermis, the duration of energization corresponds to the thermal relaxation time of the sebaceous gland tissue. When the RF frequency is selected to heat the dermis more efficiently than the ESG, the duration of energization corresponds to the thermal relaxation time of the dermal tissue between the RF electrodes and the embedded ESG. Additionally, the duration for which the RF electrodes are energized may be selected so that heat accumulates in the enlarged sebaceous glands, resulting in a higher temperature than normal sebaceous glands, which are much smaller in diameter. In various embodiments, this treatment of the sebaceous glands is referred to as selective electrothermolysis.

[0059] Another method for treating sebaceous glands may be based on selective heating and coagulation of the blood vessels that supply the glands.

[0060] During the initial diagnostic procedure, the location of the enlarged sebaceous gland is determined as described above. During the subsequent treatment procedure, high-energy treatment pulses are applied only to electrodes identified as being inside the sebaceous gland. Next, high-energy treatment pulses are delivered by electrodes identified as being near the sebaceous gland, selectively heating and coagulating all or part of the blood vessels near the gland, with the goal of reducing and / or isolating the blood supply that nourishes the gland.

[0061] Figure 4 shows the electrical conductivity of tissues at frequencies below 1 MHz by Gabriel et al., "The dielectric properties of biological tissues: I. Literature survey, Phys. Med. Biol. 41 (1996) 2231-2249," by Gabriel S, Lau RW and Gabriel C, "The dielectric properties of biological tissues: III. Parametric models for the dielectric spectrum of tissues," Physics in Medicine & Biology. 1996 Nov; 41(11):2271, and by Gabriel C, Peyman A and Grant EH, "Electrical conductivity of tissue at frequencies below 1 MHz," Phys. in medicine & biology. 2009 Jul. 27;54(16):4863, the dielectric properties of wet skin (i.e., dermis) and blood are plotted. Figure 5 plots the calculated specific electrical impedance amplitude |z| of wet skin and blood in the frequency range of 100 Hz to 1 GHz, and Figure 6 plots the calculated phase angle θ of wet skin and blood in the frequency range of 100 Hz to 1 GHz. Figure 7 plots the ratio of blood-to-dermis specific electrical impedance amplitude and phase angle. Figure 7 shows the relationship between the specific impedance of blood and the true It can be seen that there exists a wide frequency range where the specific impedance of blood differs by more than two-fold from that of the dermis. For example, in the frequency range of about 100 Hz to about 50 MHz, the specific impedance of blood is about 25% to about 50% of that of the dermis. By delivering RF power in the range of about 100 Hz to about 50 MHz from an electrode identified near the targeted sebaceous gland, selective power delivery to the blood vessels is achieved by reducing the power density delivered to the surrounding dermis (i.e., the dermis surrounding the blood vessels) to 1 / 2 to 1 / 4 of that of the blood vessels.

[0062] The low RF impedance of blood within a vessel allows for greater RF power to be delivered to a vessel located between two or more electrodes identified as being near the targeted sebaceous gland. RF power flow to the vessel and corresponding heating of the vessel damages its wall. Preferably, the RF pulse ON time is selected to produce selective heating of the vessel based on the application of selective photothermolysis theory (R. Rox Anderson et al., "Selective Photothermolysis: Precise Microsurgery by Selective Absorption of Pulsed Radiation," Science, Vol. 220, pp. 524-528) to selective heating of vessels with RF power. Higher frequency RF power delivery is preferred due to the "skin effect," which increases current density around the periphery of the RF conductor, resulting in more localized damage to the vessel wall. Within 5–100 seconds of RF power delivery, thermal, mechanical, and other damage to the vessel wall can result in total or partial coagulation of blood within the damaged vessels (Falati et al., “Real-time in vivo imaging of platelets, tissue factors, and fibrin during arterial thrombus formation in the mouse,” Nature Medicine, Volume 8, Number 10, October 2002, pp. 1175–1180; and Furie et al., “Thrombus Formation in Vivo,” The Journal of Clinical Investigation, Vol. 115:12, December 2005, pp. 3355–3362). The coagulation described here can be the initiation of a series of events leading to complete coagulation of the vessels. Clotting of blood vessels supplying sebaceous glands can lead to gland disruption until angiogenesis restores blood supply to the glands. Cutting off blood flow to sebaceous glands can reduce their size. Dysfunctional conditions of the gland can also lead to necrosis of the gland.The reduction in size or necrosis of enlarged sebaceous glands within a given skin area leads to a reduction in acne symptoms in that area.

[0063] In various embodiments, when the RF electrode is energized, high current densities can cause undesirable temperatures to build up near the RF electrode. By way of example, the delivery needle electrode may be hollow to allow for the delivery of a cold conductive liquid (e.g., saline) immediately prior to energy delivery to mitigate and / or reduce undesirable electrode temperatures.

[0064] (RF delivery equipment and devices) FIG. 8 shows an example of a needle having a liquid delivery port suitable for delivering various solutions. For example, FIG. 9 is a schematic diagram showing an example of an RF electrode needle having a liquid delivery port mounted on an electrode holder in a hexagonal pattern, in one embodiment within a hexagonal array. Openings may be formed approximately every 60° around the circumference, and may be oriented along the hexagonal grid of the electrode array. This allows the openings of two adjacent (e.g., horizontally and / or diagonally adjacent) needles to be oriented toward each other. The space between them may then be filled with liquid delivered from one or both of the adjacent needles in the array, as shown in FIG. 10. In one exemplary embodiment, it may be preferable for the openings around the circumference of each electrode to be oriented toward the nearest neighboring electrode in the electrode array, as shown in FIG. 10.

[0065] FIG. 8 is a diagram of an RF electrode needle 20 having a fluid delivery port LDP or notch around its circumference, according to one embodiment of the present disclosure. The fluid may include a conductive solution, a drug, or other compound for treating acne, enhancing healing, or cooling or modifying one or more tissue properties before, during, or after treatment. One or more needles in the array may deliver various solutions. A reservoir and pump device for each solution may be in fluid communication with a given LDP port. In some embodiments, the needle shaft may be insulated to prevent energy delivery to the epidermis or superficial dermis, where sebaceous glands are not present. The uninsulated tip region of the needle is inserted to deliver energy to approximately the depth of the sebaceous glands (SG) in the dermis. In most embodiments, the depth of the sebaceous glands in the dermis varies from about 0.5 to about 1.5 mm (or about 2 mm), or from about 0.75 to about 1.25 mm. In various embodiments, the array of electrodes or microneedles is also referred to as a needle array.

[0066] Figure 9 is a schematic diagram of an example of an RF electrode needle array 21. The illustrated needles N have liquid delivery ports LDP. The needles N are mounted in a hexagonal pattern on an electrode applicator holder (i.e., electrode applicator substrate 23). As shown in Figure 9, the liquid delivery ports LDP of the mounted electrodes are oriented to point toward the nearest electrode.

[0067] FIG. 10 is a schematic cross-sectional view illustrating an example of RF electrode needles 27 having liquid delivery ports LDPs mounted in a hexagonal pattern on an electrode applicator holder. Each needle is depicted as having six LDPs around its circumference. In various embodiments, the number of LDPs on each needle N can vary from 1 to approximately 16 LDPs. The centers of the cross sections of the needles are connected by line segments to form a hexagonal or triangular arrangement. The plane of the cross section includes various triangles extending between the needle centers, and six triangles define the hexagonal arrangement of the needles N. The cross section (and the sides of the triangles) are located midway between the liquid delivery ports and perpendicular to the axis of the electrode. In this schematic, the wall portions of the RF electrode (portions not serving as liquid delivery ports) are depicted as dark cross-hatched lines, and the liquid delivery ports are depicted as light outlines. The liquid delivery ports of the attached electrodes are oriented to point toward the nearest electrode. To emphasize the orientation of a given fluid outlet relative to the nearest electrode, dashed-dotted lines have been added connecting the centers of the RF electrodes containing the fluid outlet.

[0068] 11 is a schematic diagram showing an example of an RF electrode needle 30 having a liquid delivery port LDP around the circumference and at the tip T. The port at the tip is depicted oriented eccentrically from the center of the tip T.

[0069] 12 is a schematic diagram showing an example of an RF electrode needle 32 without a liquid delivery port. The length of this example of the needle, as well as the lengths of the other needles described herein, can be within a range of about 1 mm to about 50 mm. The length of this example of the needle that is inserted into the subject's skin tissue can be within a range of about 1 mm to about 5 mm. The thickness or diameter of this example of the needle, as well as the thickness or diameter of the other needles described herein, can be within a range of about 0.1 to about 1 mm.

[0070] 13 is a schematic diagram showing an example of an RF electrode needle 38 having a liquid delivery port LDP at its tip T. In this embodiment, the LDP is oriented eccentrically as shown.

[0071] 14 is a schematic diagram illustrating an example of an RF electrode needle array 40 mounted on an electrode holder (i.e., electrode assembly) 42. The electrode holder (i.e., electrode assembly) 42 is detachably coupled to a support structure. In some embodiments, the holder 42 allows the electrode applicator holder with attached electrodes to be removed from a handpiece or another support or structure 45. The RF electrodes may be inserted into the patient's skin. Mechanical couplers 48, such as spring-loaded connectors, press-fit ports, or the like, may cooperate with the electrode holder 42 to couple the electrode holder 42 to the handpiece 45.

[0072] In some embodiments, the electrode applicator assembly 42 is replaced or sterilized for each patient. The treatment handpiece contains complex mechanical and electronic components, as well as optional fluid delivery components. The handpiece 45 facilitates electrode insertion into the skin, RF diagnostics, optional fluid delivery, therapeutic energy delivery, and electrode removal from the skin. While not specifically illustrated, the mechanical and electronic components that facilitate electrode (e.g., microneedle) insertion and removal from the skin are known to those skilled in the art and are also present in microneedle insertion devices such as the Potenza® RF Microneedle Insertion System (manufactured by Jeisys Medical, Inc.). It is economically advantageous to make the portion of the handpiece that does not contact the patient reusable, eliminating the need for replacement between patients. Therefore, as shown, the portion of the treatment handpiece containing the microneedle array is detachably coupled to the handpiece.

[0073] In various embodiments, the conductive liquid delivered from the hollow electrode may contain an anesthetic to alleviate any pain that may accompany the procedure. In various embodiments, the individual electrode needles delivering the cryogenic liquid may be open at the tip, as shown in FIG. 13, open at the periphery, as shown in FIG. 8, or a combination thereof, as shown in FIG. 11. Other electrodes that do not deliver liquid are shown in FIG. 12.

[0074] In various embodiments, spurious electrode polarization can cause errors in the characterization of the impedance and dielectric properties of the tissue being assessed between the electrodes. Selection of electrode material and finishing can improve spurious electrode polarization. For example, platinum electrodes coated with a rough platinum black layer can reduce the effects of spurious electrode polarization.

[0075] FIG. 15 is a chart showing the dielectric properties, including permittivity and conductivity, of fat and wet skin. Wet skin data for frequencies below approximately 1 MHz are data for the lower layer of skin with the stratum corneum removed. Specifically, wet skin data for frequencies below approximately 1 MHz (approximately 0.0001 MHz to approximately 1 MHz) are data for the lower layer of skin collected after the stratum corneum was removed. Wet skin data for frequencies above approximately 1 MHz (approximately 1 MHz to approximately 1000 MHz) are from the skin layer with the stratum corneum remaining. However, at higher frequencies, such as above approximately 1 MHz, there is no difference between data with and without the stratum corneum, so there is no discontinuity between the data below approximately 1 MHz. FIGS. 3, 16, 17, and 18 were calculated based on the data in FIG. 15. Therefore, the data shown in FIGS. 3, 16, 17, and 18 also include data without the stratum corneum.

[0076] Fat is used as a surrogate for sebaceous tissue, and wet skin is used as a surrogate for dermal tissue. Figure 15 plots the relative permittivity and conductivity of fat and wet skin over the frequency range from approximately 100 Hz to approximately 1 GHz. The permittivity and conductivity of fat and wet skin allow for a wide frequency range to be examined. This allows for judicious selection of a frequency range where a strong contrast between sebaceous tissue and dermal tissue is expected to occur.

[0077] 16 is a graph showing the dielectric property ratio of fat (a surrogate for sebaceous glands) to wet skin (a surrogate for dermal tissue), specifically, the ratio of fat conductivity to wet skin conductivity (solid line) with frequency (MHz) on the x-axis, and the ratio of fat permittivity to wet skin permittivity (dashed line) with frequency (MHz) on the x-axis. As shown in FIG. 16, there are wide frequency ranges (x-axis: frequency (MHz)) where one or both of the two dielectric properties for fat and wet skin (i.e., the ratio of fat conductivity / wet skin conductivity and / or the ratio of fat permittivity / wet skin permittivity) differ by more than 2-fold, more than 5-fold, or more than 10-fold at a particular frequency and are other than 1 (e.g., the dielectric property ratio is greater than or less than 1).

[0078] Alternatively, sebaceous glands are preferably targeted at frequencies where the dielectric properties of sebum and the dermis differ from each other and the ratio of their dielectric properties is outside the range of about 0.9 to about 1.1, about 0.8 to about 1.2, or about 0.6 to about 1.4. Frequency ranges where the dielectric properties of fat and wet skin differ, for example, by more than 10-fold, more than 5-fold, or more than 2-fold, are preferred for targeting sebaceous glands. Referring again to FIG. 15 , it can be seen that ratios of 10 or greater and ratios of 0.1 or less are highly useful for diagnostic purposes, and in these regions, the ratios of the fat conductivity / wet skin conductivity and the fat permittivity / wet skin permittivity are relatively different, e.g., by more than 10-fold in many regions. Frequencies where the dielectric properties of sebum and the dermis of the skin differ from each other and the fat / wet skin conductivity ratio and / or fat / wet skin permittivity ratio are greater than, for example, 2, 5, 10, etc. are preferred for targeting the treated sebaceous glands (using fat as a surrogate for sebaceous tissue). In a given embodiment, all of the above multiples may differ by about 5% or 10%.

[0079] As shown in Figure 17, in the candidate frequency range of approximately 100 Hz to approximately 1000 MHz, the impedance of fat is higher than the impedance of wet skin. In this case, the sebaceous glands are heated by thermal diffusion from the surrounding dermis. Thermal diffusion from the surrounding tissue may be more efficient for tissue heating. By limiting thermal damage to the dermis to only the area containing the ESG between the segmented RF electrodes, the thermally damaged dermal area can be quickly restored after treatment.

[0080] In various embodiments, the control system targets electromagnetic energy to the sebaceous glands using measurements of tissue impedance. Targeting of the sebaceous glands is based on the impedance difference between the dermal tissue and the sebum. For example, the relative permittivity of the tissue, ε γ and the electrical conductivity σ, the specific admittance γ of the tissue can be calculated.

[0081]

number

[0082] (where ε0 is the dielectric constant of a vacuum, ω=2πf is the angular frequency, and i is the imaginary unit: i=√-1.)

[0083] The specific electrical impedance z is the reciprocal of the specific admittance γ.

[0084]

number

[0085] The tissue properties of interest in diagnostic procedures can be the magnitude |z| and the tangent phase angle θ of the specific electrical impedance. These terms can be written in terms of the relative permittivity and conductivity of the tissue as follows:

[0086]

number

[0087] The calculated wet skin and fat specific electrical impedance amplitude |z| is plotted in Figure 17, and the calculated wet skin and fat phase angle θ is plotted in Figure 18. The fat-to-wet skin specific electrical impedance amplitude ratio and phase angle ratio are plotted in Figure 15.

[0088] FIG. 15 is a chart of the impedance ratio of fat to wet skin versus frequency. As shown, FIG. 15 reveals that there are frequency ranges in which the specific impedance of fat and that of wet skin differ by more than two-fold, five-fold, or ten-fold. When targeting sebaceous glands, a difference in specific impedance of more than ten-fold is optimal, a difference of more than five-fold is less ideal, and a difference of more than two-fold is least desirable. Based on FIG. 15, in the candidate frequency range of approximately 100 Hz to approximately 1000 MHz, the impedance amplitude of fat is higher than that of wet skin. In this case, the sebaceous glands can be heated by thermal diffusion from the surrounding dermis, which is heated more efficiently. By limiting thermal damage to only the area containing the ESG between the segmented RF electrodes, the thermally damaged dermal area can be rapidly restored after treatment.

[0089] The graphs in Figures 3, 15, 16, 17, and 18 show the relationship between the dermis and sebaceous glands in terms of their relative electrical properties. However, the data is actually from wet skin, a surrogate for the dermis, and adipose tissue, a surrogate for the sebaceous glands. While the graphs may change slightly in the future as more accurate data on the dielectric properties of sebum and dermis, as well as data on dermal and sebaceous tissue, become available, the technical content of ESG designation and treatment with RF energy will remain consistent.

[0090] The above-described devices and methods may be extended to other localized tissue structures, tissues, organs, cells, organelles, cell outputs and products, and other conditions. For example, localized selective electrocautery of sweat glands may be applied to areas of skin that experience excessive sweating. Another example is tissue areas containing unwanted blood or gray hair. These tissue areas often do not exhibit sufficient pigment contrast for laser-based selective photothermolysis and may therefore be treated with localized selective electrocautery as disclosed herein.

[0091] (unwanted hair) The same approach described above for treating enlarged sebaceous glands can also be applied to the treatment of unwanted hair. In an initial diagnostic step, hair follicles are located by exploiting the lower electrical conductivity of the hair shaft compared to the surrounding dermis. In a subsequent treatment step, high-energy treatment pulses are applied only to electrodes identified near each identified hair follicle due to the lower electrical conductivity of the hair shaft compared to the surrounding dermis. The treatment pulses deliver high RF power to selectively heat and coagulate blood vessels near the hair follicle, either in whole or in part. This treatment technique is extremely useful for treating white, red, blonde, and light-colored hair, which are difficult to treat with conventional laser hair removal. Generally speaking, unwanted body hair can be a source of embarrassment and social anxiety for the individual. Removal or prevention of unwanted hair through cosmetic treatment of hair follicles can enhance self-esteem and reduce embarrassment and social anxiety. Therefore, cosmetic treatment of unwanted hair and other cosmetic treatments disclosed herein can provide many benefits to people and help them overcome ridicule and criticism from others in social situations.

[0092] (vascular lesions) The same approach described above for treating enlarged sebaceous glands can also be applied to treating unwanted vascular lesions. Unwanted vascular lesions on the skin are generally associated with increased blood vessel diameter and / or increased vascular density in the affected area. Examples of vascular lesions include telangiectasia, diffuse erythema, hemangiomas, and hemangiomas simplex. In each case, either increased blood vessel diameter or increased vascular density results in a high blood volume fraction in the dermis of the affected area.

[0093] In the initial diagnostic process, the differences in the dielectric properties of blood versus the dermis and the corresponding impedance amplitude and phase (Figures 4, 5, and 6) can be used to identify locations of elevated blood volume fraction. The ratio of blood-to-dermis specific electrical impedance amplitude and phase angle is plotted in Figure 7. Figure 7 shows that there is a wide frequency range where the specific impedance of blood differs from that of the dermis by more than a factor of two. For example, in the frequency range from about 100 Hz to about 50 MHz, the specific impedance of blood is about 25% to about 50% of that of the dermis. The higher the blood volume fraction, the greater the impedance variation surrounding an electrode group consisting of two or more electrodes compared to the array average of impedance measurements between similar electrodes without elevated blood volume fraction. The region with the highest blood volume fraction is targeted for energy delivery.

[0094] Generally speaking, unwanted blood vessels and vascular lesions, such as spider veins, can be a source of embarrassment and social anxiety for an individual. Removal or prevention of unwanted red spots, age spots, spider veins, and other unwanted, noticeable marks and breakouts through cosmetic treatment of blood vessels and lesions can boost self-esteem and reduce embarrassment and social anxiety. Thus, cosmetic treatment of blood vessels and lesions, as well as the other cosmetic treatments disclosed herein, can provide numerous benefits to individuals and help them overcome ridicule and criticism from others in social situations.

[0095] The low RF impedance of blood within a vessel allows for greater RF power to be delivered to a vessel located between two or more electrodes identified as being near a target region with a high blood volume fraction. RF power flow to the vessel and corresponding heating of the vessel damages its wall. Preferably, the RF pulse ON time is selected to produce selective heating of the enlarged vessel based on the application of selective photothermolysis theory to selective heating of vessels with RF power (R. Rox Anderson et al., "Selective Photothermolysis: Precise Microsurgery by Selective Absorption of Pulsed Radiation," Science, Vol. 220, pp. 524-528). Higher frequency RF power delivery is preferred due to the "skin effect," which increases current density around the periphery of the RF conductor. Within 5–100 seconds of RF power delivery, thermal, mechanical, and other damage to the vessel wall induces coagulation of blood within the injured vessels (Falati et al., “Real-time in vivo imaging of platelets, tissue factors, and fibrin during arterial thrombus formation in the mouse,” Nature Medicine, Volume 8, Number 10, October 2002, pp. 1175–1180; and Furie et al., “Thrombus Formation in Vivo,” The Journal of Clinical Investigation, Vol. 115:12, December 2005, pp. 3355–3362). Selective coagulation of all or part of the enlarged vessels is expected to reduce the elevated blood volume fraction in the target area after recovery. This reduction in elevated blood volume fraction is expected to lead to cosmetic improvement of unwanted vascular lesions.

[0096] (sweat glands) Hyperhidrosis is generally defined as excessive sweating that exceeds physiological thermoregulatory needs. The social impact of hyperhidrosis on people's lives is comparable to that of many skin disorders, such as psoriasis, acne, and vitiligo. People often adopt restrictive lifestyles to avoid the risk of excessive sweating in social situations. Preventing or improving excessive sweating through sweat gland regulation cosmetic procedures can boost self-esteem and reduce embarrassment. Common areas of excessive sweating include the axillae (i.e., underarms), palms, and soles of the feet.

[0097] It is commonly believed that there are two types of sweat glands: eccrine glands and apocrine glands. A third type of sweat gland, the apoeccrine gland, has also been discovered and is currently the subject of much discussion. Eccrine glands secrete clear, odorless sweat, and their primary function is thermoregulation. Sweat glands are distributed throughout the body, with varying numbers per unit area. Apocrine glands secrete milky-white sweat and are found primarily in the axilla and genital areas. Both types of glands are found near the dermis / subcutaneous (DH) boundary. Studies of the human axilla have shown that all or most of the sweat glands are located in the subcutaneous tissue below the DH border (Beer et al., “Immunohistochemical Differentiation and Localization Analysis of Sweat Glands in the Adult Human Axilla,” https: / / journals.lww.com / plasreconsurg / Abstract / 2006 / 05000 / Immunohistochemical Differentiation and.52.aspx).

[0098] Localized treatment of sweat glands with RF power induces thermal damage and necrosis, potentially leading to the improvement of hyperhidrosis. Microwave treatment without localizing sweat glands has been demonstrated to improve hyperhidrosis (Hong et al., "Clinical Evaluation of a Microwave Device for Treating Axillary Hyperhidrosis," 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc. ISSN: 1076-0512, Dermatol Surg 2012;38:728-735, DOI: 10.1111 / j.1524-4725.2012.02375.x). Microwave treatment without localizing sweat glands involves heating a wide area from the skin surface to the DH junction. Nonselective volumetric heating requires skin cooling and local injection of anesthetics for pain management. Localized treatment of sweat glands with RF power avoids non-selective volumetric heating and provides benefits over microwave treatment while improving safety and patient comfort.

[0099] The subcutaneous or subcutaneous tissue is made up of adipose tissue. The dielectric properties of fat (a substitute for adipose tissue) are those summarized in "The dielectric properties of biological tissues: I. Literature survey, Phys. Med. Biol. 41 (1996) 2231-2249" by Gabriel et al., "The dielectric properties of biological tissues: III. Parametric models for the dielectric spectrum of tissues" by Gabriel S, Lau RW and Gabriel C, Phys. Medicine & Biology. 1996 Nov; 41(11):2271, and "Electrical conductivity of tissue at frequencies below 1 MHz" by Gabriel C, Peyman A and Grant EH, Phys. Medicine & Biology. 2009 Jul 27;54(16):4863. The dielectric properties of artificial sweat (a substitute for human sweat) are those summarized in "Study of the Dielectric Properties of Artificial Sweat Mixtures at Microwave Frequencies" by Eldamak et al. We used the data summarized in Biosensors 2020, 10, 62. Figure 19 plots the relative permittivity and conductivity of fat and artificial sweat in the frequency range from approximately 100 Hz to approximately 1 GHz. As more accurate data on the dielectric properties of subcutaneous tissue and sweat become available, these values ​​may be updated to provide more accurate results. However, the validity of the basic concepts of sweat gland location and RF processing based on dielectric properties remains unchanged.

[0100] The same approach described above for treating enlarged sebaceous glands can also be applied to treating excessive sweating. The initial diagnostic process identifies the location of sweat glands based on the difference in the dielectric properties of sweat versus fat. The diagnostic process can also determine whether the uninsulated energy delivery electrode tip is located within the dermis or subcutaneously, based on the significant difference between fat and dermis (Figure 3). If the uninsulated electrode tip is determined to be within the dermis, it can be repositioned to penetrate subcutaneously. If the uninsulated electrode tip is located subcutaneously, the location and approximate size of the sweat gland can be determined by impedance variation diagnostics using the electrode array.

[0101] During the subsequent treatment process, high-energy treatment pulses are delivered only to those electrodes identified as being inside or near sweat glands. Because only a relatively small percentage of the electrodes in the array will be found to be near sweat glands, only a small percentage of the subcutaneous volume near these glands will experience thermal damage when energized.

[0102] Generally speaking, unwanted excessive sweating can be a source of embarrassment and social anxiety for an individual. Eliminating or preventing unwanted sweating through cosmetic treatment of sweat glands can boost self-esteem and reduce embarrassment and social anxiety. Therefore, cosmetic treatment of excessive sweating, as well as the other cosmetic treatments disclosed herein, can provide many benefits to individuals and help them overcome ridicule and criticism from others in social situations.

[0103] FIG. 19 shows that there are wide frequency ranges in which the dielectric properties of fat and sweat glands differ by more than about two times, more than about five times, or even more than about ten times. FIG. 20 plots the calculated values ​​of the specific electrical impedance amplitude ||z| between sweat and the dermis for the frequency range of about 100 Hz to about 1 GHz, and FIG. 21 plots the calculated values ​​of the phase angle θ between sweat and the dermis for the frequency range of about 100 Hz to about 1 GHz. FIG. 22 plots the ratio of the specific electrical impedance amplitude and phase angle between sweat and fat. FIG. 22 shows that in the frequency range of about 100 Hz to about 1 GHz, the specific impedance amplitude of sweat is about 1 / 10 of the impedance of fat. Selective power delivery to sweat glands is achieved by delivering RF power in the range of about 100 Hz to about 1 GHz from electrodes identified near the targeted sweat glands, thereby reducing the power density delivered to the surrounding fat to about 1 / 10 of that of the sweat glands. An RF electrode located near each identified sweat gland is energized for a time period that matches the thermal relaxation time of that gland (R. Rox Anderson, "Selective Photothermolysis: Precise Microsurgery by Selective Absorption of Pulsed Radiation," Science, Vol. 220, pp. 524-528).

[0104] The applicators and handpieces disclosed herein, and variations thereof, may be combined with control circuitry to limit and count their usage, so that exceeding treatment limits can be tracked and the handpiece can be turned off directly or remotely by the operator or control system.

[0105] Described herein are systems and methods that utilize RF energy to treat a patient's skin (e.g., dermis, subcutaneous, etc.) and other target tissues below the tissue surface with RF energy. In various embodiments of the present teachings, non-invasive RF-based treatments with or without cooling can be performed to achieve one or more of the following, but are not limited to: sebaceous gland treatment, acne treatment, sweat gland treatment, vascular treatment, spider vein treatment, gland damage / inactivation, skin tightening (improvement of laxity), cellulite treatment devices, and unwanted hair and vascular lesion removal treatments.

[0106] FIG. 23 is a block diagram showing a control system for receiving and transmitting impedance evaluation feedback during pre-treatment diagnosis, pre-treatment impedance mapping, and actual treatment. Here, AC power is converted to DC voltage by an AD converter. The DC voltage is then supplied to an RF power amplifier and then to a patient isolation section (e.g., a transformer). RF power from the patient isolation section is then supplied to the handpiece / electrodes and the electrode array (see, e.g., FIGS. 9 and 14) attached to the handpiece (e.g., FIG. 14), and then delivered to the patient through the needles of the electrode array. The RF power may be delivered in either monopolar or bipolar mode, or the same system may be capable of delivering both monopolar and bipolar modes (e.g., the Potenza® RF Microneedle Puncture System (manufactured by Jeisys Medical, Inc.) integrates 1 MHz or 2 MHz monopolar RF and bipolar RF within the same device). The electrodes of the electrode array are also referred to as needles or microneedles. RF power may be delivered to a patient at a relatively low level suitable for impedance diagnosis and / or impedance mapping. This RF power may be in the range of about 1 nanowatt to about 10 watts. Alternatively, RF power may be delivered to a patient at a level suitable for treating a target condition (e.g., acne, unwanted hair, excessive sweating, unwanted vascular lesions (e.g., unwanted blood vessels), etc.). Treatment RF power ranges are in the range of about 1 milliwatt to about 10 kilowatts or about 100 milliwatts to about 500 watts.

[0107] Although not shown in Diagram A, the DC voltage may optionally be applied to a DC buck converter section, which controllably converts the applied DC voltage to a desired RF frequency. The controlled DC voltage is then applied to the RF power amplifier section and then to a patient isolation section (e.g., a transformer section). RF power from the patient isolation section is then delivered to the patient via the handpiece / electrode disclosed herein.

[0108] (Impedance diagnosis / impedance mapping) Referring again to Figure 23, to perform impedance diagnosis / impedance mapping, relatively low levels of RF power are delivered to the patient from electrodes present on the handpiece. The control system provides control signals to multiplex the low level RF power from the array of electrodes present on the handpiece to the patient's tissue being diagnosed / mapped. The control system receives control signals for generating impedance diagnosis information and impedance maps to collect impedance information at the patient's tissue treatment site.

[0109] For example, RF power may be delivered to a patient at a relatively low level suitable for impedance diagnosis and / or impedance mapping, ranging from about 1 nanowatt to about 10 watts. As a diagnostic scan of a tissue site is performed, the control system collects control signals to measure the impedance of each electrode or electrode pair.

[0110] Impedance values ​​are determined for most, if not all, electrodes or electrode pairs in the array of the handpiece. The more electrodes or electrode pairs that are interrogated, the greater the relative accuracy of the impedance map. High and / or low impedance values ​​may be excluded from the diagnostic measurement before a baseline impedance for the particular tissue site can be determined. In one embodiment, if high and / or low impedance values ​​are determined, the microneedles or microneedle pairs associated with the high and / or low values ​​are reserved for subsequent therapeutic treatment, depending on the treatment condition of interest. In another embodiment, the system revisits high and / or low impedance values ​​after the baseline impedance is determined and determines which impedance values ​​to interrogate for therapeutic purposes based, for example, on the current frequency of the system.

[0111] (Treatment) Referring again to FIG. 23 , based on an impedance mapping of the patient's tissue, a single electrode or a selected subset of individual electrodes (monopolar mode) on the handpiece, or a selected subset of electrode pairs (bipolar mode) on the handpiece, are energized to treat the patient's tissue at a location identified from the impedance mapping as a site where the desired treatment effect will occur. To perform the treatment, RF power is delivered to the patient through the electrodes present on the handpiece. The control system provides control signals to multiplex RF power from the array of electrodes present on the handpiece to the impedance-mapped patient tissue. The control system multiplexes RF power through the single / individual electrodes (monopolar mode) or through specific electrode pairs (bipolar mode) on the handpiece based on the impedance map, which is constructed using impedance data collected from the region of the patient's tissue to be treated. For example, RF power is delivered to the patient at a level appropriate to treat the target condition (e.g., acne, unwanted hair, excessive sweating, unwanted blood vessels, etc.). Treatment RF power ranges are within the range of about 1 milliwatt to about 10 kilowatts or about 100 milliwatts to about 500 watts.

[0112] (Acne) In one embodiment, a selected subset of adjacent needle or electrode pairs are energized to treat enlarged sebaceous glands (ESGs) with RF power. Impedance mapping can be used to identify ESGs with relatively large or largest diameters. The mapped ESGs are then treated with an RF power range and duration appropriate for treatment. Impedance mapping can also be used to identify ESGs with the highest lipid concentration between the electrode pairs. The mapped ESGs are then treated with an RF power range and duration appropriate for treatment. A larger ESG represents a relatively higher lipid concentration in the space between the needle pairs. Specifically, each needle pair can be energized for a time approximately equal to the thermal relaxation time of the tissue between the needle pairs (bipolar mode). When a single needle (or some individual needles) directly contacts the ESGs, each single / individual electrode can be energized for a time approximately equal to the thermal relaxation time of the tissue in contact with the electrode (monopolar mode). Depending on the treatment session, selective RF heating requires high power / output for short periods of time, either with single / individual needles (monopolar mode) or needle pairs (bipolar mode).

[0113] (excessive sweating) In one embodiment, a selected subset of adjacent needle or electrode pairs are energized to therapeutically treat sweat glands with RF energy. The presence of sweat glands can be identified through impedance mapping. A selected subset of these mapped sweat glands are then treated with RF power ranges and durations appropriate for treatment. Specifically, each needle pair can be energized for a time approximately equal to the thermal relaxation time of the tissue between each needle pair (bipolar mode). Depending on the treatment session, selective RF heating requires high power / power for short periods of time. In one embodiment, all identified sweat glands at a patient's tissue site are treated with RF power ranges and durations appropriate for treatment.

[0114] (Removal of unwanted hair) In one embodiment, a selected subset of adjacent needle or electrode pairs are energized to therapeutically treat unwanted hair follicles with RF energy. Impedance mapping can identify the presence of hair shafts within the follicles. A selected subset of these mapped follicles are then treated with RF power ranges and durations appropriate for hair removal treatment. Specifically, each needle pair can be energized for a time approximately equal to the thermal relaxation time of the tissue between each needle pair (bipolar mode). Depending on the treatment session, selective RF heating requires short periods of high power / power. In one embodiment, all unwanted hair follicles identified as present in the patient's tissue site are treated with RF power ranges and durations appropriate for treatment.

[0115] (unnecessary blood vessels) In one embodiment, selected pairs of adjacent needle or electrode pairs are energized to treat unwanted blood vessels with RF power. Impedance mapping can identify unwanted blood vessels based on their high blood volume fraction. The mapped unwanted blood vessels are then treated with an RF power range and duration appropriate for treatment. Alternatively, impedance mapping can be used to identify unwanted blood vessels based on the proportion of dilated blood vessels. The mapped unwanted blood vessels are then treated with an RF power range and duration appropriate for treatment. Specifically, each needle pair can be energized for a time approximately equal to the thermal relaxation time of the tissue between each needle pair (bipolar mode). When a single needle (or some individual needles) directly contacts the unwanted blood vessel, each single / individual electrode can be energized for a time approximately equal to the thermal relaxation time of the tissue in contact with that electrode (monopolar mode). Depending on the treatment session, selective RF heating requires short-term high power / power, whether using a single / individual needle (monopolar mode) or a pair of needles (bipolar mode).

[0116] Generally speaking, the methods and systems disclosed herein can be used to perform a variety of non-medical treatments, including cosmetic treatments, aesthetic treatments, and combinations thereof. Cosmetic treatment of tissue to reduce or prevent excessive sweating, removal of unwanted hair, removal of blood vessels and lesions, and reduction or prevention of acne are all beneficial cosmetic treatments. These and other cosmetic treatments disclosed herein can improve the appearance and well-being of people suffering from the above conditions and other conditions disclosed herein. In various embodiments, the present disclosure relates to methods for controlling the delivery of RF energy to one or more tissue targets to reduce, prevent, reverse, or cosmetically treat one or more undesirable conditions disclosed herein through cosmetic treatment.

[0117] Further details of various systems for treating tissue using RF and impedance sensing are disclosed in U.S. Patent Application Publication No. 20200352633 ("NON-INVASIVE, UNIFORM AND NON-UNIFORM RF METHODS AND SYSTEMS RELATED APPLICATIONS"), the entire disclosure of which is incorporated by reference.

[0118] Further details of various systems for treating tissue using RF and impedance detection are disclosed in U.S. Patent Application Publication No. 20190239939 ("METHODS AND APPARATUS FOR CONTROLLED RF TREATMENTS AND RF GENERATOR SYSTEM"), the entire disclosure of which is incorporated by reference.

[0119] It should be understood that, for clarity, the following description describes various aspects of embodiments of the applicant's teachings while omitting some specific details where deemed convenient or appropriate. For example, descriptions of similar or similar components may be omitted for the sake of brevity in alternative embodiments. Furthermore, well-known ideas and concepts may not be described in detail for the sake of brevity. Those skilled in the art will appreciate that, depending on the embodiment of the applicant's teachings, some of the details specifically described may be included herein merely to provide a thorough understanding of the embodiment and may not be essential in all implementations. Similarly, it is apparent that changes and modifications may be made to the described embodiments in accordance with common knowledge without departing from the scope of the present disclosure. The following detailed description of the embodiments should in no way be construed as limiting the scope of the applicant's teachings.

[0120] As used herein, the terms "about" and "substantially the same" refer to variations in numerical quantities that may occur, for example, due to real-world measurement or handling procedures, inadvertent errors in these procedures, variations / defects in the manufacture of electrical elements, electrical losses, and variations that would be recognized by one of ordinary skill in the art as equivalent, provided the variations do not encompass known values ​​practiced by the prior art. Generally, the term "about" refers to a tenth of a value or range of values, e.g., ±10%. For example, applying a direct current (DC) voltage of about +3V to an element may refer to a voltage between +2.7VDC and +3.3VDC. Similarly, values ​​that are "substantially the same" may differ by up to 5%. Whether modified by the terms "about" or "substantially the same," quantitative values ​​recited in the claims also include equivalents to the recited values, e.g., variations in the numerical quantities of the values ​​that may occur but would be recognized as equivalents by one of ordinary skill in the art.

[0121] Furthermore, nothing disclosed herein is intended to be publicly available, regardless of whether such disclosure is expressly recited in the claims. To assist the Patent Office and readers of patents issued based on this application in interpreting the claims appended hereto or otherwise presented throughout the prosecution of this or any continuing patent application, applicants are advised that they do not intend any claimed feature to be construed under or subject to the provisions of 35 U.S.C. 112(f) unless the phrase "means for" or "step for" is expressly used in a particular claim.

[0122] All drawings attached hereto contain one or more ornamental features and figures, and each drawing contains solid lines, any of which may also be incorporated into, correspond to, and provide support for, dotted lines; alternatively, each drawing contains dotted lines, any of which may also be incorporated into, correspond to, and provide support for, the solid lines.

[0123] Use of the terms "comprises," "equips," "contains," "includes," "has," and "having" should generally be understood as open and non-limiting, unless otherwise specified.

[0124] As used herein, the use of the singular includes the plural (and vice versa) unless otherwise specified. Furthermore, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Furthermore, where the term "about" is used before a quantitative value, the present teachings also encompass the specific quantitative value itself unless otherwise specified.

[0125] It should be understood that the order of processes / steps or order for performing certain actions is immaterial so long as the present teachings remain operable. Further, two or more processes / steps or actions may be conducted simultaneously.

[0126] When a range or list of values ​​is provided, each intervening value between the upper and lower limits of that range or list of values ​​is individually contemplated and encompassed within the disclosure as if each value were specifically recited herein. Moreover, smaller ranges between and including the upper and lower limits of a given range are also contemplated and encompassed within the disclosure. The recitation of exemplary values ​​or ranges does not exclude other values ​​or ranges between and including the upper and lower limits of the given range.

[0127] It should be understood that numerous modifications may be made to the embodiments of the present disclosure without departing from the scope of the teachings of the present application. While specific configurations / components are referenced in the foregoing figures and examples, this is for illustrative purposes only and is not intended to limit the present invention. Those skilled in the art will appreciate that various modifications in form and detail of the embodiments of the present disclosure may be made without departing from the scope of the teachings encompassed by the appended claims. [Aspect 1] 1. A method of treating acne, comprising: providing a needle array comprising a plurality of needles; inserting a plurality of needles into the dermis at the treatment site; the process of detecting the location of enlarged sebaceous glands; energizing at least one of the plurality of needles to treat the enlarged sebaceous glands; A method for providing the above. [Aspect 2] The method of embodiment 1, wherein the diameter of the enlarged sebaceous glands is greater than about 50 μm. The method of embodiment 1, wherein the step of detecting the location of enlarged sebaceous glands comprises: delivering a low power pulse from each of said plurality of needles; collecting impedance data for each of the plurality of needles; and determining, based on the collected impedance data, a needle among the plurality of needles that is in the vicinity of the enlarged sebaceous gland; A method comprising: Aspect 4 A method according to aspect 3, wherein the low-power pulses are a series of low-power pulses that are repeatedly delivered until the collected impedance data exhibits contrast suggestive of the presence or absence of enlarged sebaceous glands. Aspect 5 In the method according to aspect 1, the energizing step comprises: delivering energy from a needle located near the enlarged sebaceous gland among the plurality of needles; A method comprising: Aspect 6 The method of embodiment 1, wherein at least one needle has a liquid delivery outlet and a flow path for receiving a solution. Aspect 7 7. The method of claim 6, wherein the solution is a conductive solution. Aspect 8 The method of embodiment 1, further comprising: designating at least one needle of the plurality of needles according to an energization method such as a multiplexing method; A method for providing the above. Aspect 9 The method of embodiment 1, wherein the plurality of needles are arranged in hexagonal needle clusters with one needle within each cluster. Aspect 10 The method of embodiment 1, wherein normal-sized sebaceous glands are excluded from the energy exposure. Aspect 11 The method of embodiment 1, wherein the step of detecting the location of enlarged sebaceous glands further comprises: performing impedance mapping of the treatment area; A method comprising: Aspect 12 12. The method of claim 11, wherein the step of detecting the location of enlarged sebaceous glands further comprises: identifying the enlarged sebaceous glands in response to one or more impedance measurements obtained from the impedance mapping; A method comprising: Aspect 13 The method of embodiment 1, wherein the step of detecting the location of enlarged sebaceous glands further comprises: measuring the impedance difference between two adjacent needles spanning the sebaceous gland; A method comprising: Aspect 14 The method of embodiment 1, further comprising: performing a diagnostic impedance measurement on the treatment site; A method for providing the above. Aspect 15 The method of embodiment 14, further comprising: excluding high and / or low impedance values ​​from said diagnostic measurement; A method for providing the above. Aspect 16 1. A method of performing a cosmetic treatment on tissue, comprising: providing a needle array comprising a plurality of needles; inserting a plurality of needles into one or more tissue layers at a treatment site; detecting the location of the tissue object; energizing at least one of the plurality of needles to perform a cosmetic treatment on one or more portions of a tissue object; A method for providing the above. Aspect 17 The method of embodiment 16, wherein the tissue target is selected from the group consisting of a hair follicle, a sweat gland, a vascular lesion, a blood vessel, and a sebaceous gland. Aspect 18 17. The method of embodiment 16, wherein the location of the tissue object is: delivering a low power pulse from each of said plurality of needles; collecting impedance data for each of the plurality of needles; and determining which of the plurality of needles is proximate to the tissue target based on the collected impedance data; A method comprising: Aspect 19 18. The method of embodiment 17, wherein the step of detecting the location of the tissue object further comprises: measuring an impedance difference between two adjacent needles across the tissue object; A method comprising: Aspect 20 17. The method of claim 16, wherein the step of detecting the location of the tissue object further comprises: performing impedance mapping of the treatment area; A method comprising:

Claims

1. A substrate; a needle array extending from the substrate, the needle array including a plurality of needles arranged according to a pattern; a handpiece coupled to the electrode assembly; a control system in electrical communication with the plurality of needles, the control system detects the location of an enlarged sebaceous gland in response to the impedance measured using at least two of the plurality of needles, energizes at least one of the plurality of needles to treat the enlarged sebaceous gland, delivers a low power pulse through each of the plurality of needles, and collects impedance data for each of the plurality of needles; the low-power pulses are a series of low-power pulses delivered until the collected impedance data exhibits a contrast indicative of the presence or absence of enlarged sebaceous glands; A system in which normal sized sebaceous glands are excluded from energy exposure in response to the collected impedance data exhibiting the contrast.

2. 10. The system of claim 1, further comprising a radio frequency (RF) power amplifier in electrical communication with the plurality of needles, the RF power amplifier generating at least one RF signal for energizing at least one of the plurality of needles.

3. 10. The system of claim 1, wherein the pattern includes hexagonal needle clusters with at least one needle within each cluster.

4. 10. The system of claim 1, wherein the enlarged sebaceous glands have a diameter greater than about 50 μm.

5. 2. The system according to claim 1, wherein the control system includes: A system for determining which of the plurality of needles is in the vicinity of the enlarged sebaceous gland based on the collected impedance data.

6. 2. The system of claim 1, wherein the control system sends energy to a needle of the plurality of needles that is positioned near the enlarged sebaceous gland in order to energize at least one of the plurality of needles.

7. 10. The system of claim 1, wherein at least one needle has a fluid delivery outlet and a fluid channel for receiving a solution.

8. 8. The system of claim 7, wherein the solution is a conductive solution.

9. 2. The system according to claim 1, wherein the control system designates at least one of the plurality of needles according to an energization method such as a multiplexing method.

10. 10. The system of claim 1, wherein detecting the location of the enlarged sebaceous glands further comprises performing impedance mapping of the treatment area.

11. 11. The system of claim 10, wherein detecting the location of the enlarged sebaceous gland further comprises identifying the enlarged sebaceous gland in response to one or more impedance measurements obtained in the impedance mapping.

12. 10. The system of claim 1, wherein detecting the location of the enlarged sebaceous gland further comprises measuring an impedance difference between two adjacent needles that straddle the sebaceous gland.

13. 10. The system of claim 1, wherein the control system further performs diagnostic impedance measurements related to the treatment site.

14. 14. The system of claim 13, wherein the control system further excludes high and / or low impedance values ​​from the diagnostic impedance measurement.

15. A substrate; a needle array extending from the substrate, the needle array having a plurality of needles arranged according to a pattern; a handpiece coupled to the electrode assembly; a control system in electrical communication with the plurality of needles, the control system detects a location of an enlarged tissue object in response to the measured impedance using at least two of the plurality of needles; energizes at least one of the plurality of needles to cosmetically treat at least one of the enlarged tissue objects; delivers a low power pulse through each of the plurality of needles; and collects impedance data for each of the plurality of needles. the low-power pulses are a series of low-power pulses delivered until the collected impedance data exhibits a contrast indicative of the presence or absence of enlarged sebaceous glands; A system in which normal sized tissue objects are excluded from energy exposure in response to said collected impedance data exhibiting contrast.

16. 16. The system of claim 15, wherein the tissue target is a blood vessel.

17. 16. The system of claim 15, wherein to detect the location of the enlarged tissue object, the control system comprises: A system for determining which of the plurality of needles is proximate to the enlarged tissue target based on the collected impedance data.

18. 16. The system of claim 15, wherein the control system further measures an impedance difference between two adjacent needles that straddle the tissue object to detect the location of the tissue object.

19. 16. The system of claim 15, wherein the tissue target is a sebaceous gland.

20. 20. The system of claim 19, wherein the normal-sized tissue object is a sebaceous gland of normal size, and the enlarged tissue object is an enlarged sebaceous gland, and the normal-sized sebaceous gland has a diameter of about 50 μm or less.

21. 21. The system of claim 20, wherein the enlarged sebaceous glands have a diameter greater than 100 μm.

22. 10. The system of claim 1, wherein the diameter of the normal-sized sebaceous gland is about 50 μm or less.

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