Needle array device and related methods

Abstract

The present disclosure relates, in part, to a method of treating acne, excessive sweating, unwanted hair, and / or unwanted blood vessels. The method can include providing a needle array comprising a plurality of needles; inserting the plurality of needles into a dermis of a treatment area; detecting a location of an enlarged sebaceous gland; and exciting one or more of the plurality of needles to treat the sebaceous gland, one or more sweat glands, a vascular lesion, an unwanted hair follicle, and / or an unwanted blood vessel.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority and benefit to U.S. Provisional Patent Application No. 63 / 020,461, filed May 5, 2020, the disclosure of which is incorporated herein by reference in its entirety. Background Technology

[0003] Acne treatment is a major concern for dermatologists. Acne leads to millions of visits to dermatologists each year. Typically, acne appears in early adolescence and subsides by the mid-twenties. In many cases, especially in women, acne remains a chronic problem into adulthood.

[0004] Acne vulgaris, the most common form of acne, results from sebum secreted by the sebaceous glands entering clogged pores. Continued secretion leads to a buildup of sebum in the clogged pores. Bacteria in the pores can cause infection and a common, unsightly skin condition known as papules. Sebaceous hyperplasia is also a common form of acne, in which the sebaceous glands grow or enlarge due to excessive sebum production.

[0005] In the past, doctors used radiation therapy to destroy sebaceous glands to treat acne. However, radiation does not specifically target sebaceous glands and, due to its mutagenic toxicity, can cause significant morbidity in normal tissue. An increased risk of skin cancer is also associated with radiation therapy. Many acne treatments cannot selectively eradicate sebaceous glands without damaging surrounding normal tissue, and are therefore still non-curative and inadequate. The result is years of chronic treatment and potential scarring for patients.

[0006] This disclosure relates to systems and methods for using contact-based technologies to address some or all of the above-described problems and to otherwise provide acne treatment and other cosmetic procedures. Summary of the Invention

[0007] In part, the systems and methods discussed herein treat tissues in the human body. In certain variants, the systems and methods described below treat skin conditions that occur when hair follicles are 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.

[0008] Furthermore, in part, this disclosure relates to systems and methods for identifying sebaceous glands in the face and other tissue areas using tissue characterization circuitry and for targeting these sebaceous glands using a handheld applicator to treat or prevent acne. In various embodiments, a microneedle array is used, comprising groups of needles arranged according to a regular pattern such as a hexagon or other regular polygon, the needles positioned at their vertices and at the center or otherwise located within the vertices. The needles may also be referred to as electrodes, such that the microneedle array may be an electrode array.

[0009] In part, this disclosure relates to a method for treating acne. The method includes providing a needle array comprising a plurality of needles; inserting the plurality of needles into the dermis of a treatment area; detecting the location of enlarged sebaceous glands; and stimulating one or more of the plurality of needles to treat the enlarged sebaceous glands.

[0010] In one embodiment, the enlarged sebaceous gland has a diameter greater than about 50 μm. In one embodiment, the detection includes transmitting a low-power pulse through each of a plurality of needles; collecting impedance data associated with each of the plurality of needles; and determining, based on the collected impedance data, which of the plurality of needles is near the enlarged sebaceous gland. In one embodiment, the low-power pulse is a series of low-power pulses transmitted repeatedly until the collected impedance data displays a contrast indicating the presence or absence of the enlarged sebaceous gland.

[0011] In one embodiment, the excitation involves transmitting energy through a needle located near an enlarged sebaceous gland among a plurality of needles. In one embodiment, one or more needles include a liquid delivery port and a channel for receiving a solution. In one embodiment, the solution is a conductive solution.

[0012] In one embodiment, the method further includes addressing one or more needles among a plurality of needles according to an excitation scheme such as a multiplexed sequence. In one embodiment, the plurality of needles are arranged in a hexagonal needle cluster, with one needle disposed within each such cluster. In one embodiment, a normal-sized sebaceous gland is exempt from targeted energy exposure.

[0013] In one embodiment, detecting the location of an enlarged sebaceous gland further includes performing impedance mapping associated with the treatment area. In one embodiment, detecting the location of an enlarged sebaceous gland further includes identifying the enlarged sebaceous gland in response to one or more impedance measurements obtained during impedance mapping. In one embodiment, detecting the location of an enlarged sebaceous gland further includes measuring the impedance difference between two adjacent needles across the sebaceous gland. In one embodiment, the method further includes performing diagnostic impedance measurements associated with the treatment area. In one embodiment, the method further includes excluding high impedance values ​​and / or low impedance values ​​from the diagnostic measurements.

[0014] In part, this disclosure relates to a method for treating excessive sweating. The method includes providing a needle array comprising a plurality of needles; inserting the plurality of needles into the subepithelial layer of a treatment area; detecting the location of one or more sweat glands and stimulating one or more of the plurality of needles to treat the one or more sweat glands.

[0015] In one embodiment, the detection includes transmitting a low-power pulse through each of a plurality of needles; collecting impedance data associated with each of the plurality of needles; and determining, based on the collected impedance data, which of the plurality of needles is near one or more sweat glands. In one embodiment, the low-power pulse is a series of low-power pulses transmitted repeatedly until the collected impedance data displays a contrast indicating the presence or absence of one or more sweat glands.

[0016] In one embodiment, the excitation involves transmitting energy through a needle located near one or more sweat glands among a plurality of needles. In one embodiment, the one or more needles include a liquid delivery port and a channel for receiving a solution. In one embodiment, the solution is a conductive solution.

[0017] In one embodiment, the method further includes addressing one or more needles among a plurality of needles according to an excitation scheme such as a multiplexed sequence. In one embodiment, the plurality of needles are arranged in a hexagonal needle cluster, with one needle disposed within each such cluster. In one embodiment, a portion of one or more sweat glands is exempt from targeted energy exposure.

[0018] In one embodiment, detecting the location of one or more sweat glands further includes performing impedance mapping associated with the treatment area. In one embodiment, detecting the location of one or more sweat glands further includes identifying one or more sweat glands in response to one or more impedance measurements obtained during impedance mapping. In one embodiment, detecting the location of one or more sweat glands further includes measuring the impedance difference between two adjacent needles across one or more sweat glands. In one embodiment, the method further includes performing diagnostic impedance measurements associated with the treatment area. In one embodiment, the method further includes excluding high impedance values ​​and / or low impedance values ​​from the diagnostic measurements.

[0019] In part, this disclosure relates to a method for treating unwanted hair. The method includes providing a needle array comprising a plurality of needles; inserting the plurality of needles into the dermis of a treatment area containing unwanted hair; detecting the hair shaft location of unwanted hair follicles; and stimulating one or more of the plurality of needles to treat the unwanted hair follicles.

[0020] In one implementation, the detection includes sending a low-power pulse through each of a plurality of needles; collecting impedance data associated with each of the plurality of needles; and determining, based on the collected impedance data, which of the plurality of needles is near an unwanted hair shaft. In one implementation, the low-power pulse is a series of low-power pulses that are repeatedly sent until the collected impedance data displays a contrast indicating the presence or absence of an unwanted hair shaft.

[0021] In one embodiment, the excitation involves sending energy through a needle located near an unwanted hair follicle among a plurality of needles. In one embodiment, one or more needles include a liquid delivery port and a channel for receiving a solution. In one embodiment, the solution is a conductive solution.

[0022] In one embodiment, the method further includes addressing one or more of a plurality of needles according to a multiplexing sequence such as an excitation scheme. In one embodiment, the plurality of needles are arranged in a hexagonal needle cluster, with one needle disposed within each such cluster.

[0023] In one embodiment, detecting the location of unwanted hair further includes performing impedance mapping of the hair shaft of the unwanted hair follicle. In one embodiment, detecting unwanted hair further includes identifying the unwanted hair shaft in response to one or more impedance measurements obtained during impedance mapping. In one embodiment, detecting the location of unwanted hair further includes measuring the impedance difference between two adjacent needles across the unwanted hair shaft. In one embodiment, the method further includes performing diagnostic impedance measurements associated with the treatment area. In one embodiment, the method further includes excluding high impedance values ​​and / or low impedance values ​​from the diagnostic measurements.

[0024] In part, this disclosure relates to a method for treating vascular injury. The method includes providing a needle array comprising a plurality of needles; inserting the plurality of needles into the dermis of a treatment area; detecting the location of one or more blood vessels (e.g., unwanted blood vessels); and stimulating one or more of the plurality of needles to treat the one or more blood vessels (e.g., one or more unwanted blood vessels).

[0025] In one embodiment, the detection further includes transmitting a low-power pulse through each of the plurality of needles; collecting impedance data associated with each of the plurality of needles; and determining, based on the collected impedance data, which of the plurality of needles is near one or more blood vessels. In one embodiment, the low-power pulse is a series of repeatedly transmitted low-power pulses until the collected impedance data displays a contrast indicating the presence or absence of one or more blood vessels. In one embodiment, excitation includes transmitting energy through a needle located near one or more blood vessels. In one embodiment, the one or more needles include a liquid delivery port and a channel for receiving a solution. In one embodiment, the solution is a conductive solution.

[0026] In one embodiment, the method further includes addressing one or more needles among a plurality of needles according to an excitation scheme such as a multiplexed sequence. In one embodiment, the plurality of needles are arranged in a hexagonal needle cluster, with one needle disposed within each such cluster. In one embodiment, a region having one or more vessels containing normal blood concentrations is exempt from targeted energy exposure. In one embodiment, detecting the location of one or more vessels further includes performing impedance mapping associated with the treated region. In one embodiment, detecting the location of one or more vessels further includes identifying one or more enlarged vessels in response to one or more impedance measurements obtained during impedance mapping.

[0027] 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 during impedance mapping. In one embodiment, detecting the location of one or more blood vessels further includes measuring the impedance difference between two adjacent needles spanning one or more blood vessels. In one embodiment, detecting the location of one or more regions of elevated blood volume fraction further includes measuring the impedance difference between two adjacent needles spanning one or more regions of elevated blood volume fraction. In one embodiment, the method further includes performing diagnostic impedance measurements associated with the treated area. In one embodiment, the method further includes excluding high impedance values ​​and / or low impedance values ​​from diagnostic measurements. In some embodiments, certain blood vessels are detected by impedance mapping but intentionally left untreated, while other detected blood vessels are treated by exciting one or more of a plurality of needles via RF power, because one or more treated blood vessels are expected or understood to be one or more visible vascular lesions, and treatment of some or all of these blood vessels is expected to improve the cosmetic appearance of the one or more vascular lesions.

[0028] In part, this disclosure relates to a method of treating tissue. The method includes providing a needle array comprising a plurality of needles; inserting the plurality of needles into one or more tissue layers of a treatment area; detecting the location of a tissue target; and stimulating one or more of the plurality of needles to cosmetically treat one or more portions of the tissue target.

[0029] In one embodiment, the tissue target is selected from one or more of the group consisting of hair follicles, sweat glands, blood vessels, vascular lesions, and sebaceous glands. In one embodiment, detecting the location of the tissue target further includes transmitting low-power pulses through each of the plurality of needles; collecting impedance data associated with each of the plurality of needles; and determining, based on the collected impedance data, which of the plurality of needles is near the tissue target. In one embodiment, detecting the location of the tissue target further includes performing impedance mapping associated with the treatment area.

[0030] Although this disclosure relates to different aspects and embodiments, it should be understood that the different aspects and embodiments disclosed herein may be integrated, combined, or used together as a combined system, or in part as separate components, devices, and systems, as appropriate. Therefore, each embodiment disclosed herein may be incorporated into each aspect to varying degrees, depending on the suitability of a given implementation. Furthermore, the various systems, probes, applicators, needle arrays, controllers, components, and parts described above can be used with any suitable tissue surface, cosmetic and aesthetic application, as well as medical applications and other methods, and in combination with other devices and systems, but are not limited thereto.

[0031] This article describes these and other characteristics of the applicant's teaching. Attached Figure Description

[0032] Figure 1A and Figure 1B This is a schematic diagram illustrating the application of a needle array to tissue to identify and treat certain types of tissue or organ structures, such as enlarged sebaceous glands, according to an illustrative embodiment of the present disclosure.

[0033] Figure 2A and Figure 2B This is a schematic diagram illustrating the application of a needle array to tissue to identify and treat certain types of tissue or organ structures, such as enlarged sebaceous glands, according to an illustrative embodiment of the present disclosure.

[0034] Figure 3 It is a graph showing the ratio of the impedance characteristics of fat to wet skin in the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., about 100 Hz to about 1 GHz) according to the illustrative embodiments of the present disclosure, in particular the ratio of the impedance amplitude of fat to that of wet skin (represented by solid lines) and the ratio of the phase angle of fat impedance to that of wet skin impedance (represented by dashed lines).

[0035] Figure 4 It is a graph showing the dielectric constant and conductivity of blood as four different curves compared to wet skin (as a substitute for dermal tissue) in the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz) according to an illustrative embodiment of the present disclosure.

[0036] Figure 5 It is a graph showing the specific impedance amplitude of blood versus wet skin (as a substitute for dermal tissue) as two different curves in the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz) according to an illustrative embodiment of the present disclosure.

[0037] Figure 6It is a graph showing the phase angle of blood as two different curves compared to wet skin (as a substitute for dermal tissue) in the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz) according to an illustrative embodiment of the present disclosure.

[0038] Figure 7 It is a graph showing the impedance amplitude ratio and impedance phase angle ratio of blood as two different curves in the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz) according to an illustrative embodiment of the present disclosure.

[0039] Figure 8 This is a schematic diagram of an exemplary RF electrode needle having a liquid delivery port surrounding its outer periphery, according to an illustrative embodiment of the present disclosure.

[0040] Figure 9 This is a schematic diagram of an exemplary RF electrode needle with a liquid delivery port mounted on an electrode applicator holder in a hexagonal pattern according to an illustrative embodiment of the present disclosure.

[0041] Figure 10 This is a schematic cross-sectional view of an exemplary RF electrode needle with a liquid delivery port mounted on an electrode applicator holder in a hexagonal pattern according to an illustrative embodiment of the present disclosure.

[0042] Figure 11 This is a schematic diagram of an exemplary RF electrode needle having a liquid delivery port around its periphery and a liquid delivery port at its tip, according to an illustrative embodiment of the present disclosure.

[0043] Figure 12 This is a schematic diagram of an exemplary RF electrode needle without a liquid delivery port according to an illustrative embodiment of the present disclosure.

[0044] Figure 13 This is a schematic diagram of an exemplary RF electrode needle having a liquid delivery port at its tip, according to an illustrative embodiment of the present disclosure.

[0045] Figure 14 This is a schematic diagram of an exemplary RF electrode needle mounted on an electrode holder according to an illustrative embodiment of the present disclosure, which enables the electrode applicator holder with attached electrodes to be disconnected from the handheld device.

[0046] Figure 15It is a graph showing the dielectric properties (including dielectric constant and conductivity) of wet skin (as a substitute for dermal tissue) and fat (as a substitute for sebaceous tissue) in the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz), all data of which are derived from Gabriel S, Lau RW, 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, Grant EH. Electrical conductivity of tissue at frequencies below 1 MHz Physics in medicine & Biology. 2009 Jul 27; 54(16): 4863.

[0047] Figure 16 It is a graph showing the ratio of the dielectric properties of fat (as a substitute for sebaceous glands) to that of moist skin (as a substitute for dermal tissue) in the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz), in particular the ratio of the conductivity of fat to that of moist skin (represented by solid lines) and the ratio of the dielectric constant of fat to that of moist skin (represented by dashed lines).

[0048] Figure 17 This is a graph showing the specific electrical impedance amplitudes of wet skin (as a substitute for dermal tissue) represented by solid lines and fat (as a substitute for sebaceous tissue) represented by dashed lines in the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., about 100 Hz to about 1 GHz) according to an illustrative embodiment of the present disclosure.

[0049] Figure 18 This is a graph showing the specific impedance phase angles of wet skin (as a substitute for dermal tissue) represented by solid lines and fat (as a substitute for sebaceous tissue) represented by dashed lines in the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., about 100 Hz to about 1 GHz) according to an illustrative embodiment of the present disclosure.

[0050] Figure 19It is a graph showing the relative permittivity and conductivity of fat and artificial sweat as four different curves in the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz) according to an illustrative embodiment of the present disclosure.

[0051] Figure 20 It is a graph showing the specific impedance amplitude of sweat versus fat as two different curves in the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz) according to an illustrative embodiment of the present disclosure.

[0052] Figure 21 It is a graph showing the phase angles of sweat versus fat as two different curves in the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz) according to an illustrative embodiment of the present disclosure.

[0053] Figure 22 It is a graph showing the impedance amplitude ratio and impedance phase angle ratio of sweat versus fat as two different curves in the frequency range of about 0.0001 MHz to about 1000 MHz (e.g., 100 Hz to 1 GHz) according to an illustrative embodiment of the present disclosure.

[0054] Figure 23 A block diagram of a temperature-controlled circuit topology for an RF-based system according to an illustrative embodiment of the present disclosure is shown schematically. Detailed Implementation

[0055] The disclosed technologies describe devices and methods for delivering energy to sebaceous glands to treat acne and / or to detect certain types of sebaceous glands for treatment. Sebaceous glands are located in the dermis of the skin. They are distributed throughout the body except for the palms and soles; they are most abundant on the scalp and face. Sebaceous glands function by producing and releasing the lipid substance sebum, which helps protect and lubricate the skin surface. Sebum contains lipids, cellular debris, and keratin. Acne is often associated with enlarged sebaceous glands; for example, acne occurs when the outlet from the sebaceous gland to the skin surface is blocked, causing sebum to accumulate in the hair follicle and leading to sebaceous gland enlargement. RF energy is directed to a treatment device comprising an array of needles, wherein the needles are operable to deliver the RF treatment energy to tissues, and particularly to features within the tissue, such as enlarged sebaceous glands, for treatment. Sebaceous glands help maintain the moisture and lubrication of the skin and hair. Furthermore, some studies have shown that sebaceous glands also contribute to the functioning of the immune system. Therefore, for any acne treatment that focuses on treating enlarged sebaceous glands, it is important that the treatment also preserves the normal sebaceous glands that provide or support important functions for the skin and the underlying immune system.

[0056] In one implementation, treatment is performed across tissue regions (e.g., between a pair of needle electrodes). The array may be integrated into one or more handheld devices or applicators. In some implementations, the array is a detachable consumable, such as, for example, a detachable needle array.

[0057] Suitable microneedle systems can have power delivery levels ranging from about 1 milliwatt to about 10 kilowatts, or from about 100 milliwatts to 100 watts. Such microneedle systems can deliver RF energy for a period of about 1 ns to about 10 seconds, or about 1 microsecond to about 1 second, or about 1 millisecond to about 500 milliseconds.

[0058] Suitable microneedle systems include microneedle electrodes, also known as needle electrodes and / or electrodes, and these can be non-insulated, insulated, or substantially insulated, such that only the tip of the needle is non-insulated, allowing RF energy to be delivered at the target depth of the tip within the tissue. The target depth of the needle electrode can vary depending on the target tissue; for example, sebaceous glands are located at a depth of approximately 1 to 2 mm from the skin surface, and sweat glands are located at a depth below the dermal / subcutaneous junction, ranging from approximately 2 to approximately 5 mm from the skin surface. Each needle electrode can have a diameter ranging from approximately 100 to approximately 1000 micrometers, more preferably from approximately 200 to approximately 600 micrometers. The relatively small diameter of the needle is desirable to avoid pressure / pain upon entering the skin surface, which must be balanced with the need for the electrode to remain straight / unbent during repeated use. Future material advancements may result in electrodes with even smaller diameters that meet this requirement.

[0059] In various embodiments, treatments are applied in several treatment periods to reduce the size of one or more enlarged sebaceous glands, damage, and / or destroy one or more enlarged sebaceous glands. In turn, the reduction in size, damage, or destruction of such glands, and / or exposure to RF energy, alleviates the symptoms of acne vulgaris or sebaceous hyperplasia. Furthermore, in various embodiments, RF energy is applied in controlled amounts and / or according to time-varying patterns, such as through multiplexed delivery via various needle clusters, to interfere with sebum production by the sebaceous glands. During the several treatment periods, the enlarged sebaceous glands may be modulated or controlled, or otherwise altered relative to their pre-treatment state, to reduce or stop sebum production. In some embodiments, occasional treatments may be applied after the initial treatment program to prevent, mitigate, or otherwise alter acne events and / or flare-ups.

[0060] Normally, sebum provides the skin with moisturizing and lubricating compounds and may play a role in the skin's immune barrier. However, in some cases, one or more enlarged sebaceous glands may overproduce sebum. Without adhering to a specific theory or mechanism, acne vulgaris appears to be a response to changes (e.g., increased) in sebum secretion from the sebaceous glands and the flow of sebum to the skin surface. Typically, increased sebum production in the sebaceous glands and / or restricted or blocked sebum flow lead to the typical symptoms of acne vulgaris or sebaceous gland hyperplasia.

[0061] Other energy-based treatments for acne vulgaris involve devices that deliver energy to the affected area. However, these devices are often unable to pinpoint the location of sebaceous glands in the dermis without auxiliary devices. Typically, various individual imaging techniques can be used to identify the location of sebaceous glands, including confocal microscopy, optical coherence tomography, multiphoton microscopy, and other similar techniques that take into account the scattering characteristics of the human dermis. These imaging techniques are often used in conjunction with subsequent targeted energy delivery, which preserves most of the epidermis and dermis and destroys the sebaceous glands with minimal damage to surrounding tissue. These methods can be combined with one or more embodiments disclosed herein and benefit from synergy with the needle arrays and treatment modalities disclosed herein.

[0062] In various embodiments, this disclosure describes methods and systems for detecting and targeting sebaceous glands and subsequently guiding and delivering RF energy, said RF energy being configured to treat the sebaceous glands within a target area. In various embodiments, the RF energy diagnostic and delivery device includes an array of electrodes (also referred to as needles or microneedles). Figure 1A and Figure 1B This is a schematic diagram illustrating the application of a needle array 5 (also known as a microneedle array or electrode array) to tissue to identify and treat certain types of tissue or organ structures, such as enlarged sebaceous glands. Figure 1A and Figure 1B As shown, an array of needles with individual needles N is generally displayed. Each needle N is electrically connected to 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 needles attached to the patient's body or between at least one needle and a neutral electrode pad.

[0063] For the entire needle array 5, there exist clusters or one or more sub-arrays of needles that can be arranged in various patterns. These needles contact the tissue including sebaceous gland SG and enlarged sebaceous gland ESG. Normal sebaceous gland SG has a diameter measured to be less than or equal to about 50 μm. Enlarged sebaceous gland ESG has a diameter measured to be greater than 100 μm, for example, between 100 μm and 1 mm, or for example, between 100 μm and 5 mm. Figure 1A In, clusters C1 and C2, and in Figure 1BCluster C2 is shown as individual hexagonal clusters or subarrays. Six needles are positioned at the vertices, and one needle is positioned at the center. Within cluster C2, needles N1 and N2 are shown relative to the enlarged sebaceous gland ESG. Figure 2A and Figure 2B Also shown is a needle array 10 with multiple needles N and hexagonal clusters C3 and C4.

[0064] For any electrode, choosing a hexagonal arrangement of needle clusters offers an advantage for an ordered arrangement with the largest number of equidistant nearest neighbors (six in this case). Sebaceous glands in the skin can be located using hexagonal clusters or arrays of needles, including electrodes or needles (such as microneedles). The dermis and sebum, as lipids, have different impedances; the impedance of the dermis is similar to that of wet skin, while the impedance of sebum is similar to that of adipose tissue. As a result, diagnostic scanning of the needle grid locates adjacent needles with a high sebum concentration (enlarged sebaceous glands) in the spaces between them. For example, in Figure 1A and Figure 2A In this process, a scanning procedure is used to distinguish between SG and ESG. Then, as... Figure 1B and Figure 2B The diagram shows ESG being processed using RF. In Figure 2B In the middle, two ESGs are processed simultaneously.

[0065] When scanning normal sebaceous glands, such as those with a diameter less than or equal to about 50 μm, the impedance measurement obtained as the difference between two adjacent needles spanning the sebaceous gland will be the lowest impedance difference or within the range of the lower impedance difference characteristic of normal (i.e., unenlarged) sebaceous glands, or in the scan area where there is no other tendency for sebaceous glands. The edge-to-edge spacing between microneedles in the array can vary between about 100 μm and about 3 mm, or between about 100 μm and about 1 mm, or between about 200 μm and about 500 μm.

[0066] Compared to baseline measurements, larger sebaceous glands (e.g., ESG) show greater impedance changes. Smaller sebaceous glands (SG) will show smaller impedance changes compared to baseline. The baseline can be defined as the average impedance measured by the electrode array after excluding outliers (e.g., high or low impedance). For a given treatment period, a microneedle array is inserted into the tissue area. The array can be releasably or directly coupled to a reusable or disposable handheld device. A diagnostic scan of the tissue area is performed to measure the impedance of each electrode, or alternatively, the impedance between each pair of electrodes. High and / or low impedance values ​​from this diagnostic measurement are excluded, and a baseline impedance is established for that particular tissue area. In one implementation, when an impedance value is determined to be high and / or low, the microneedle or microparticle associated with that high and / or low value is designated for subsequent therapeutic treatment. In another implementation, once the baseline impedance is determined, the system will subsequently revisit the high and / or low impedance values ​​and determine, based on, for example, the system's fundamental frequency, which impedance values ​​to query for therapeutic purposes.

[0067] The edge-to-edge spacing between microneedles in the array can vary between approximately 100 μm and approximately 1 mm, and between approximately 200 μm and approximately 500 μm. For example, in Figure 3 In this regard, we anticipate that based on the contrast we see in impedance amplitude ratios of approximately 0.01 MHz to approximately 1000 MHz, approximately 0.03 MHz to approximately 500 MHz, and approximately 1 MHz to approximately 10 MHz, it will be possible to design a diagnostic system that can distinguish between the presence and absence of enlarged sebaceous gland ESG.

[0068] In other embodiments, the array can be configured in shapes other than hexagons, including but not limited to rectangles, pentagons, octagons, circles, or other geometries. The electrode or microneedle array is inserted into the treatment area of ​​the skin prior to treatment. Figure 1A and Figure 1B as well as Figure 2A and Figure 2B Each array 5, 10 shown is depicted as contacting the tissue for the treatment period.

[0069] In various embodiments, once the electrode array (e.g., a needle array or microneedle array) is correctly positioned, the treatment of the affected sebaceous gland is a two-step process. First, in at least one instance, a low-energy diagnostic pulse is applied to the needle array. Each sebaceous gland is located based on the difference in dielectric properties between sebum and the dermis of the skin. The control system enables the needle array to be excited using a monopolar or bipolar scheme. In the monopolar diagnostic step, the electrode inserted into the sebaceous gland is identified using the impedance between each electrode in the needle array and the neutral return electrode. In some cases, a needle from the needle array may accidentally insert into the sebaceous gland. In the bipolar diagnostic step, the location of the sebaceous gland located between the electrodes of the array is calculated using the impedance measured between pairs or groups of two, three, or more electrodes. In various embodiments, the control system sequentially excites each available group of two, three, or more electrodes to map each sebaceous gland in the treatment area defined by the needles in the needle array.

[0070] The diagnostic process concludes by identifying the subset of electrodes in the needle array that have been directly inserted into the sebaceous glands (accidentally) and the nearest pair (or larger group of electrodes) surrounding other sebaceous glands. In various implementations, the use of impedance variations determines the location of the sebaceous glands and their approximate size. Larger sebaceous glands, when surrounded by groups of two or more electrodes, exhibit greater impedance variations compared to the average impedance of the needle array measured between similar electrode groups in the absence of sebaceous glands.

[0071] In one implementation, the stimulus targets a selected subset, such as... Figure 1A and Figure 1B N1 and N2 or Figure 2A and Figure 2B The N3 and N4 pairs, and the N5 and N6 pairs, are targeted to treat enlarged sebaceous gland ESGs using RF energy. These pairs can be selected based on the ESGs with the highest lipid concentrations identified in the diagnostic steps, and then treated using the appropriate treatment method. Specifically, as... Figure 1B and Figure 2B As shown, these targets can be excited over a time interval approximately equal to the thermal relaxation time of the tissue between each corresponding target, wherein RF is delivered to initiate selective RF heating. For some processing periods, selective RF heating will require short periods of high power.

[0072] In one implementation, the array is selectively stimulated to control or alleviate pain. Simultaneously stimulating a selected subset of needles at short time intervals can reduce associated pain. Applying shorter pulses at the therapeutic level is sometimes considered less painful than delivering longer pulses of the same energy. Alternatively, the array can be selectively stimulated to control or alleviate pain by treating only one or more ESGs at a time. Cooling and other techniques may also be used. In various implementations, the needle array is implemented as a handheld device or applicator that can be used with one or more umbilical cord or combined treatment systems. Skin cooling can be provided to control pain by distracting the patient.

[0073] In various implementations, impedance variation provides a method for estimating the size of a located sebaceous gland. Typically, an uninflamed sebaceous gland has a diameter of about 50 μm or less. However, in various cases, when the output of the sebaceous gland is blocked, the gland size increases, it may be inflamed, and may have a diameter of one millimeter or more. Larger sebaceous glands show a larger impedance variation compared to a baseline. Smaller glands will show a smaller impedance variation compared to a baseline. The baseline can be defined as the average impedance measured by the electrode array after excluding outliers (e.g., high or low impedance). In various implementations, the controller system selects the largest sebaceous gland ESG for energy delivery. A threshold can be defined as the ESG being processed being 50%, 2 times, 3 times, 4 times, or 5 times larger than a normal-sized SG. Normal-sized and smaller-sized sebaceous glands result in smaller impedance contrast and can remain intact. A cyclic processing scheme from the largest to the smallest ESG can be selected based on available RF power and pain level. Alternatively, all ESGs can be processed with a single short pulse. In any case, the control system selects the ESGs to be processed so that each processed area is surrounded by an unprocessed area.

[0074] In various embodiments, the diagnostic steps can be performed at frequencies at which the specific impedance of the sebaceous gland exhibits a large dynamic change when heated. For example, in one embodiment, the diagnostic steps begin at a frequency corresponding to approximately twice or more the specific impedance difference between the sebaceous gland and the epidermis. The diagnosis is then performed in two phases. In the first phase, an intermediate-power diagnostic pulse is applied between the diagnostic electrode sets. The intermediate-power diagnostic pulse is selected such that it produces the desired dynamic change in specific impedance without undesirable heating effects, such as avoiding dermal coagulation. The intermediate diagnostic power is selected such that the change in specific impedance in the sebaceous gland due to intermediate-power RF heating is much larger than that in the surrounding dermis. In the second phase (possibly in parallel with the first phase), impedance localization is based on the observed dynamic change in sebaceous gland impedance due to intermediate-power RF heating compared to a much smaller change in dermal impedance. The diagnostic power level can vary between approximately 1 nanowatt and approximately 10 watts. A preferred power level for the exemplary component will be determined, and it is based on actual tissue testing including the parasitic impedance of the exemplary component.

[0075] In another embodiment, the diagnostic step can be performed by scanning a range of specific impedances and / or their ratios in the sebaceous glands and / or dermis that change rapidly with the diagnostic frequency. This diagnostic method can be particularly advantageous when the parasitic impedance of the diagnostic system including electrodes produces data with a low signal-to-noise ratio. For example, based on the specific impedance phase angle ratio, i.e. Figure 3 The ratio of the fat impedance amplitude to the wet skin impedance phase angle (shown as a dashed line) plotted in the image provides a range of rapidly changing specific impedance phase angle ratios in the frequency range of approximately 1 kHz to approximately 1 MHz. In various embodiments, when determining the location of the sebaceous gland, where fat is a substitute for sebaceous gland tissue and wet skin is a substitute for dermal tissue, the optimal frequency allows for contrast between the specific impedance of the sebaceous gland and the surrounding dermis.

[0076] In various implementations, after locating the target sebaceous gland, the controller system directs higher-power processing pulses (pulses suitable for processing rather than detection / diagnosis) to each electrode identified as being inside or near the target sebaceous gland (e.g., an enlarged sebaceous gland). In most cases, only a relatively small portion of the electrodes in the needle array will be located near the target sebaceous gland, resulting in only a small portion of the dermis near the target sebaceous gland being thermally damaged.

[0077] In various implementations, the RF power level during the treatment period can vary between about 0.001 watts and about 1000 watts. A preferred power level for the exemplary component will be determined, and it will be based on actual tissue testing including the parasitic impedance of the exemplary component. For example, a preferred treatment power level for the exemplary component can be determined by examining a set of skin tissue sections having treatments corresponding to different power levels. In turn, the corresponding damage to enlarged sebaceous glands can be evaluated in each tissue section. This evaluation may also include verifying that normal-sized sebaceous glands are undamaged. The relevant power levels associated with tissue sections having damaged / damaged large sebaceous glands and undamaged normal-sized glands can be used to set the power level for a given treatment period.

[0078] In some implementations, delivering partial energy to the dermis causes additional benefits such as collagen remodeling and skin tightening. In various implementations, the control system preferentially excites the electrodes with the greatest impedance difference, allowing thermally damaged tissue portions to heal without undesirable side effects. The control system can select the ESG to be treated so that each treated area is surrounded by an untreated area. This non-uniform or adaptive “partial” treatment accelerates tissue healing.

[0079] In various implementations, under optimal conditions, the treatment frequency can be selected such that the impedance of the target sebaceous gland is lower than that of the surrounding dermis. In this case, the sebaceous gland is heated more effectively and reaches a higher temperature than the surrounding dermis; for example, the target sebaceous gland temperature is expected to be above approximately 45°C during treatment.

[0080] In other implementations, the processing frequency can be selected so that the impedance of the sebaceous gland is similar to or higher than that of the surrounding dermis. In this case, the sebaceous gland may still be heated to a higher temperature than the surrounding dermis due to their lower heat capacity and lower thermal conductivity. Alternatively, the processing frequency can be selected so that the impedance of the sebaceous gland is similar to or higher than that of the surrounding dermis. In this case, the sebaceous gland will be heated by heat diffusion from the more effectively heated surrounding dermis. Limiting thermal damage in the dermis to areas containing ESG between the tiered RF electrodes will allow the thermally damaged dermal areas to heal rapidly after treatment. For the available frequency data range of approximately 100 Hz to approximately 1 GHz for fatty and wet skin, fatty skin impedance is higher than wet skin impedance, and this corresponds to more efficient heat generation in the dermis and heating of the sebaceous gland by heat diffusion from the surrounding dermis.

[0081] When an RF frequency is selected to heat the ESG more effectively than the dermis, the excitation period corresponds to the thermal relaxation time of the sebaceous tissue. When an RF frequency is selected to heat the dermis more effectively than the ESG, the excitation period corresponds to the thermal relaxation time of the ESG embedded between the dermal tissue and the RF electrode. Furthermore, the excitation period of the RF electrode assembly can be selected to allow the enlarged sebaceous gland to accumulate heat and raise its temperature to levels much higher than that of a normally smaller sebaceous gland. In various embodiments, this treatment of the sebaceous gland is referred to as selective electropyrolysis.

[0082] Alternative methods for treating sebaceous glands can be based on selective heating and coagulation of the blood vessels supplying the glands.

[0083] In the first diagnostic step, the location of the enlarged sebaceous gland is determined as described above. In the second treatment step, higher-energy treatment pulses are initially delivered only to electrodes identified as being located within the sebaceous gland. Then, even higher-energy treatment pulses are delivered using electrodes identified as being close to the sebaceous gland; these pulses selectively heat and coagulate all or part of the blood vessels near the sebaceous gland. The aim is to reduce and / or eliminate the blood supply to the sebaceous gland.

[0084] The dielectric properties of wet skin or dermis and blood are plotted on Figure 4The above data are based on the following: Gabriel et al., “The dielectric properties of biological tissues: I Literature survey, Phys. Med. Biol. 41 (1996) 2231-2249, and Gabriel S, Lau RW, 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, Grant EH. Electrical conductivity of tissue atfrequencies below 1MHz Physics in medicine & Biology. 2009 Jul 27; 54 (16): 4863. For frequencies between 100 Hz and 1 GHz, the calculated specific electrical impedance amplitude |z| and phase angle θ of wet skin and blood are plotted on Figure 5 and Figure 6 Above. The ratio of the resistivity amplitude and phase angle of blood to that of dermis is plotted on... Figure 7 superior. Figure 7 This indicates the existence of a wide frequency range where the specific impedance of blood and dermis differs by more than a factor of 2. For example, at frequencies between approximately 100 Hz and approximately 50 MHz, the specific impedance of blood is between approximately 25% and approximately 50% of that of dermis. Delivering RF power in the range of approximately 100 Hz to approximately 50 MHz through electrodes identified as being close to the target sebaceous gland will result in selective power delivery to the blood vessel, with the power density delivered to the surrounding dermis (i.e., the dermis surrounding the blood vessel) being at most as low as 1 / 2 to 1 / 4 of that.

[0085] The lower RF impedance of blood in a vessel will result in higher RF power delivery through vessels identified as located between two or more electrodes near the target sebaceous gland. RF power flowing through the vessel and associated vascular heating can lead to damage to the vessel wall. Based on the theory of selective photothermolysis, the preferred RF pulse conduction time is selected to induce selective heating of the vessel (R. Rox Anderson et al., “Selective Photothermolysis: Precise Microsurgery by Selective Absorption of Pulsed Radiation,” Science, Vol. 220, pp. 524-528), applying RF power to selectively heat blood vessels. Higher frequency RF power delivery would be preferred due to the “skin effect” of the larger current density around the RF conductor and more localized damage to the vessel wall. Thermal, mechanical, and other damage to the vessel wall can cause complete or partial blood coagulation in the damaged vessel within 5 to 100 seconds after RF power delivery (Falati et al., “Real-time in vivoimaging of platelets, tissue factor, 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 herein can include the initiation of a cascade of events leading to complete vascular coagulation. Coagulation of the vessels supplying the sebaceous glands will lead to gland destruction until angiogenesis re-establishes blood flow to the glands. Disruption of blood flow to the glands may result in a reduction in the size of the sebaceous glands. Glandular destruction may also lead to glandular necrosis. Reducing the size of sebaceous glands in enlarged skin areas or causing necrosis will lead to a decrease in acne symptoms in those areas.

[0086] In various implementations, when the RF electrode is energized, the region near the RF electrode may reach undesirable temperatures due to the high current density. In one instance, the undesirable electrode temperature can be mitigated and / or reduced by hollowing out the delivery needle electrode, thereby allowing a cold conductive liquid (e.g., brine) to be delivered just before energy delivery.

[0087] Devices and equipment for RF transmission

[0088] Figure 8 An exemplary needle with a liquid delivery port suitable for delivering various solutions is shown. For example, in one embodiment, within a hexagonal array, Figure 9 The diagram illustrates an exemplary RF electrode needle with a liquid delivery port mounted on an electrode holder in a hexagonal pattern. The outer peripheral openings can be fabricated in angular increments of approximately 60° and oriented along a hexagonal electrode array grid. This allows two adjacent needles (e.g., horizontally adjacent and / or diagonally adjacent) to have openings oriented towards each other, such that the space between them can be permeated with liquid delivered from one or both of the adjacent needles in the array, such as... Figure 10 As shown. In an exemplary embodiment, the openings around the periphery of each electrode can be preferentially oriented toward the nearest adjacent electrode in the electrode array, such as, for example... Figure 10 As shown.

[0089] Figure 8 This is a diagram of an RF electrode needle 20 according to one embodiment of the present disclosure, having a liquid delivery port LDP or incision around its periphery. The liquid may include a conductive solution, drug, or other compound for treating acne, improving healing, or additionally cooling or altering one or more tissue properties before, during, or after treatment. Various solutions can be delivered via one or more needles in an array. A reservoir and pump assembly for a given solution may be in fluid communication with a given LDP port. In some embodiments, the needle shaft may be insulated, such that no energy delivery is possible in the epidermis and superficial dermis where sebaceous glands are absent. The non-insulated needle tip region is inserted to deliver energy at a depth approximately equal to the sebaceous gland SG in the dermis. In most embodiments, the depth of the sebaceous gland in the dermis is between about 0.5 and about 1.5 mm (down to about 2 mm) or varies between about 0.75 and about 1.25 mm. In various embodiments, the electrode or microneedle array is referred to as a needle array.

[0090] Figure 9 This is a schematic diagram of an exemplary RF electrode needle array 21. The needle N shown includes a liquid delivery port (LDP). The needle N is mounted in a hexagonal pattern on an electrode applicator holder or substrate 23. Figure 9 As shown, the liquid delivery port (LDP) of the installed electrode is oriented towards the nearest electrode.

[0091] Figure 10This is a cross-sectional schematic of an exemplary RF electrode needle array 27 with liquid delivery ports (LDPs) mounted on an electrode applicator holder in a hexagonal pattern. Each needle is shown as having six LDPs around its circumference. In various embodiments, the number of LDPs per needle N can vary between 1 and 16 LDPs. Multiple line segments connect the center of the needle cross-section to define the arrangement of hexagons and triangles. The cross-sectional plane includes multiple triangles spanning the center of the needle, such that six triangles define the hexagonal arrangement of the needle N. The cross-section (and the sides of the triangles) is located at the center of the liquid delivery ports and is perpendicular to the axis of the electrode. The walled portions of the RF electrodes (those not containing the liquid delivery ports) are shown as darker shaded areas in the schematic, while the liquid delivery ports are shown as lighter outlined areas. The liquid delivery ports of the mounted electrodes are oriented toward the nearest electrode. Dashed lines connecting the centers of the RF electrodes to the liquid delivery ports are drawn to emphasize the orientation of certain liquid delivery ports relative to the nearest electrode.

[0092] Figure 11 This is a schematic diagram of an exemplary RF electrode needle 30, which has a liquid delivery port LDP around its outer periphery and a liquid delivery port LDP at its tip T. The port at the tip is shown as having an off-center orientation at the tip T.

[0093] Figure 12 This is a schematic diagram of an exemplary RF electrode needle 32 without a liquid delivery port. The length of the exemplary needle and other needles described herein can range from about 1 mm to about 50 mm, and the length of the exemplary needle inserted into the subject's skin tissue can range from about 1 mm to about 5 mm. The thickness or diameter of the exemplary needle and other needles described herein can range from about 0.1 to about 1 mm.

[0094] Figure 13 This is a schematic diagram of an exemplary RF electrode needle 38 having a liquid delivery port LDP at its tip T. As shown, in the illustrated embodiment, the LDP is off-center oriented.

[0095] Figure 14 This is a schematic diagram of an exemplary RF electrode needle array 40 mounted on an electrode holder or assembly 42. The electrode holder or assembly 42 is releasably coupled to a support structure. In some embodiments, the holder 42 has the ability to disconnect an electrode applicator holder with attached electrodes from a handheld device or another support or structure 45. The RF electrodes can be inserted into the patient's skin. A mechanical coupler 48, such as a spring-loaded coupler or a friction-fit socket, can work with the electrode holder 42 to couple it to the handheld device 45.

[0096] In some embodiments, the electrode applicator assembly 42 is replaced or sterilized between patients. The handling 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 retraction from the skin. Mechanical and electronic components that facilitate the insertion and retraction of electrodes (e.g., microneedles) from the skin are not specifically shown here, but are known to those skilled in the art and exist in microneedle devices, such as the Potenza manufactured by Jeisys Medical, Inc. TM RF microneedle system. The handheld portion, which does not come into contact with the patient, is reusable, eliminating the need for replacement between patients, which is economically advantageous. Therefore, as shown, the portion of the applicator including the microneedle array is releasably coupled to the handheld portion.

[0097] In various embodiments, the conductive liquid delivered via the hollow electrodes may contain an anesthetic to alleviate procedural pain. In various embodiments, the individual electrode needles for delivering the cold liquid may have openings at their tips, such as, for example... Figure 13 As shown, it has an opening on its outer periphery, such as, for example Figure 8 As shown, or a combination of both, such as, for example Figure 11 As shown. Alternatively, for example, Figure 12 The image shows an electrode without liquid delivery.

[0098] In various implementations, spurious electrode polarization can be a source of error in characterizing the impedance and dielectric properties of tissues assessed between electrodes. The choice of electrode material and surface finish can improve spurious electrode polarization. For example, platinum electrodes coated with a roughened platinum black layer can reduce the impact of spurious electrode polarization.

[0099] Figure 15 This is a graph showing the dielectric properties of fatty and wet skin, including dielectric constant and conductivity. Wet skin data at frequencies below about 1 MHz are used as data for the lower skin layer without a stratum corneum. Specifically, wet skin data at frequencies below about 1 MHz (about 0.0001 MHz to about 1 MHz) are used as data for the lower skin layer where the stratum corneum has been removed prior to data collection. Wet skin data at frequencies above about 1 MHz (about 1 MHz to about 1000 MHz) are taken from skin layers including a complete stratum corneum, but this data shows no discontinuity compared to the data obtained below about 1 MHz, because at higher frequencies, such as above about 1 MHz, the data with and without a stratum corneum are identical. Figure 3 , Figure 16 , Figure 17 and Figure 18 Based on Figure 15 The data in the calculation is from the data in the calculation. Therefore, Figure 3 , Figure 16, Figure 17 and Figure 18 The data described in the text is also based on the absence of a stratum corneum.

[0100] Fat serves as a substitute for sebaceous tissue, and moist skin serves as a substitute for dermal tissue. Figure 15 The relative permittivity and conductivity of fatty and moist skin are shown in the range of approximately 100 Hz to approximately 1 GHz. The permittivity and conductivity of fatty and moist skin allow us to observe a wide frequency range. This enables us to make informed choices within the possible frequency range where there is a strong contrast between sebaceous and dermal tissues.

[0101] Figure 16 This is a graph showing the ratio of the dielectric properties of fat (as a substitute for sebaceous glands) to that of moist skin (as a substitute for dermal tissue) on the y-axis. Specifically, the ratio of fat conductivity to moist skin conductivity (represented by a solid line) is compared to a frequency in MHz on the x-axis, and the ratio of fat dielectric constant to moist skin dielectric constant (represented by a dashed line) is compared to a frequency in MHz on the x-axis. Figure 16 As shown, there is a wide frequency range, which is displayed on the x-axis as frequencies in MHz, where one or both of the two dielectric properties of fat and wet skin (i.e., the fat / wet skin conductivity ratio and / or the fat / wet skin dielectric constant ratio) differ by more than a factor of 2, 5 or 10 at a specific frequency, and where the dielectric property ratio is not equal to 1 (e.g., greater than or less than a dielectric property ratio of 1).

[0102] Alternatively, sebaceous glands are preferentially targeted at frequencies where the dielectric properties of sebum and dermal skin differ and where the dielectric property ratio differs from 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. For example, sebaceous glands are targeted under preferred conditions at frequencies where the dielectric properties of fat and moist skin change by more than 10-fold, more than 5-fold, and more than 2-fold. It is worth noting that reference is still made to... Figure 15 For diagnostic purposes, dielectric property ratio data displayed on the y-axis are particularly useful for ratios of 10 or greater and 0.1 or less, in which regions the characteristics of the fat / wet skin conductivity ratio and fat / wet skin dielectric constant ratio vary relatively greatly, for example, greater than 10 times in many regions. Targeting sebaceous glands (fat being a substitute for sebaceous tissue) is preferred for treatment at frequencies where the dielectric properties of sebum and the dermis differ and where the fat / wet skin conductivity ratio and / or fat / wet skin dielectric constant ratio is, for example, greater than 2, greater than 5, or greater than 10. In a given embodiment, all the foregoing factors may vary by about 5% or 10%.

[0103] like Figure 17As shown, within the considered frequency range of approximately 100 Hz to approximately 1000 MHz, the impedance of fat is greater than that of wet skin. In this case, the sebaceous glands will be heated by thermal diffusion from the surrounding dermis. In some cases, thermal diffusion from surrounding tissues provides more effective tissue heating. Limiting thermal damage in the dermis to areas containing ESG between graded RF electrodes will allow thermally damaged dermal areas to heal rapidly after treatment.

[0104] In various implementations, when using electromagnetic energy to target sebaceous glands, the controller system utilizes measured tissue impedance. Sebaceous gland targeting is based on the impedance difference between sebum and dermal tissue. For example, the relative permittivity ε of the tissue... r The conductivity σ can be used to calculate the admittance γ of a tissue.

[0105] γ=σ+iωε r ε0

[0106] Where ε₀ is the dielectric constant of vacuum, ω = 2πf is the angular frequency, and i is the imaginary unit. The specific electrical impedance z is the reciprocal of the admittance γ.

[0107]

[0108] During diagnostic procedures, the measured tissue properties can be the magnitude |z| of the specific impedance and its tangent at the phase angle θ. These terms can be written in terms of the tissue's relative permittivity and conductivity, as follows:

[0109]

[0110]

[0111] The calculated specific impedance amplitude |z| and phase angle θ of wet skin and fat are plotted on... Figure 17 and Figure 18 Above. The ratio of the resistivity amplitude and phase angle of fat to that of wet skin is plotted on... Figure 15 superior.

[0112] Figure 15 This is a graph comparing the frequency of fat versus wet skin to the impedance ratio. As shown, Figure 15 This indicates a frequency range where the impedance difference between fatty and moist skin exceeds 2, 5, or 10 times. Optimal targeting of sebaceous glands occurs when the impedance change is greater than 10 times (ideally greater than 5 times, with the lowest preferred level), and greater than 2 times (with the lowest preferred level). Figure 15Within the considered frequency range of approximately 100 Hz to approximately 1000 MHz, the impedance amplitude of fat is greater 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 effectively. Limiting thermal damage in the dermis to areas containing ESG between graded RF electrodes will allow thermally damaged dermal areas to heal rapidly after treatment.

[0113] exist Figure 3 , Figure 15 , Figure 16 , Figure 17 and Figure 18 The figure illustrates the relationship between the dermis and sebaceous glands as represented by their relative electrical properties; however, the data are actually wet skin data as a substitute for the dermis, and adipose tissue data as a substitute for the sebaceous glands. In the future, data from dermal and sebaceous gland tissues, or other more accurate data on the dielectric properties of sebum and dermis, may become available, and therefore the figure may change, but the technical analysis utilizing RF energy to resolve and process ESG will remain consistent.

[0114] Extensions of the described apparatus and methods are conceivable for use on other localized tissue structures and for various tissues, organs, cells, organelles, cell outputs and products, and other conditions. For example, location-guided selective electropyrolysis of sweat glands can be applied to areas of skin that are excessively sweaty. Another example is tissue areas with unwanted blonde and white hair. These tissue areas typically have insufficient pigment contrast for laser-based selective photopyrolysis and can therefore be treated using location-guided selective electropyrolysis as disclosed herein.

[0115] unwanted hair

[0116] Similar methods described above for treating enlarged sebaceous glands can also be applied to the treatment of unwanted hair. In the first diagnostic step, the location of the hair follicle is determined by using the lower conductivity of the hair shaft compared to the surrounding dermis. In the second treatment step, higher-energy treatment pulses are delivered only to electrodes identified as being adjacent to the hair follicle, these electrodes having previously been identified by the lower conductivity of their respective hair shafts compared to the surrounding dermis. The treatment pulses are used to deliver higher RF power, thereby selectively heating and coagulating all or part of the blood vessels near the hair follicle. Such treatment techniques will be particularly suitable for treating white, red, blonde, and light-colored hair that is difficult to treat with conventional laser hair removal. Generally, unwanted body hair can cause embarrassment and social anxiety. The ability to cosmetically treat hair follicles to remove or prevent unwanted hair can help improve self-esteem and reduce embarrassment and social anxiety. Therefore, the cosmetic treatments for unwanted hair and other cosmetic treatments disclosed herein offer numerous benefits and help overcome ridicule and criticism from others in social situations.

[0117] Vascular injury

[0118] Similar methods described above for treating enlarged sebaceous glands can also be applied to treating unwanted vascular damage. Unwanted vascular damage on the skin is typically associated with an increase in the diameter or density of blood vessels in the affected area. Examples of vascular damage include telangiectasia, diffuse erythema, hemangioma, and erythema. In both cases, the volume fraction of blood in the dermis of the affected area increases due to the increased diameter or density of blood vessels.

[0119] In the first diagnostic step, the location of the increased blood volume fraction can be determined by comparing the difference in dielectric properties between blood and dermis, as well as the corresponding impedance amplitude and phase. Figure 4 , Figure 5 and Figure 6 The ratio of the resistivity amplitude and phase angle of blood to that of dermis is plotted on... Figure 7 superior. Figure 7 This indicates the existence of a wide frequency range where the specific impedance of blood and dermis differs by more than a factor of 2. For example, for frequencies between approximately 100 Hz and approximately 50 MHz, the specific impedance of blood is between approximately 25% and approximately 50% of that of dermis. When surrounded by a group of two or more electrodes, a larger blood volume fraction will result in a greater impedance change compared to the array-average impedance measured between similar electrode groups without an increased blood volume fraction. The region with the highest blood volume fraction will become the target for energy delivery.

[0120] Generally, unwanted blood vessels (such as spider veins) or vascular damage can be a source of embarrassment and social anxiety. The ability to cosmetically treat blood vessels and lesions to remove or prevent unwanted erythema, skin discoloration, spider veins, or other unwanted visible marks or blemishes can boost self-esteem and reduce embarrassment and social anxiety. Therefore, the cosmetic treatments for blood vessels and lesions, and other cosmetic procedures disclosed in this article, offer numerous benefits and help people overcome ridicule and criticism from others in social situations.

[0121] The lower RF impedance of blood in a vessel will result in higher RF power delivery through the vessel between two or more electrodes identified as being located near a target region with an elevated blood volume fraction. RF power flowing through the vessel and associated vascular heating can lead to damage to the vessel wall. Based on the theory of selective photothermolysis, the preferred RF pulse conduction time is selected to induce selective heating of the dilated vessel (R. Rox Anderson et al., “Selective Photothermolysis: Precise Microsurgery by Selective Absorption of Pulsed Radiation,” Science, Vol. 220, pp. 524-528), through the application of RF power to selective vascular heating. Higher frequency RF power delivery would be preferred due to the “skin effect” of the larger current density around the RF conductor. Thermal, mechanical, and other damage to the vessel wall will cause blood coagulation in the damaged vessel within 5 to 100 seconds after RF power delivery (Falati et al., “Real-time in vivoimaging of platelets, tissue factor 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 vessel is expected to result in a decrease in the elevated blood volume fraction in the target area after healing. This reduction in the elevated blood volume fraction is expected to improve the visual appearance of unwanted vascular damage.

[0122] sweat glands

[0123] Hyperhidrosis is generally defined as excessive sweating beyond what is physiologically necessary for regulating body temperature. The social impact of hyperhidrosis on a patient's life is comparable to many skin conditions such as psoriasis, acne, and vitiligo. Patients sometimes restrict their lifestyle choices to avoid the risk of excessive sweating in social situations. Appropriate cosmetic treatments of the sweat glands to prevent or improve excessive sweating can help build self-esteem and reduce embarrassment. Common examples of areas with excessive sweating are the armpits, or armpits, palms, and soles of the feet.

[0124] Generally, two types of sweat glands are accepted: eccrine and apocrine glands. A third type, "apoeccrine," has also been identified and discussed. Eccrine glands secrete clear, odorless sweat, and their primary function is to regulate body temperature. Sweat glands are distributed throughout the body, with varying numbers per unit area. Apocrine glands secrete milky sweat; these glands are mainly found in the armpits and genital area. Both types of glands are located near the dermal / subcutaneous DH interface. In a study of the human armpit, all or most sweat glands were found to be located in the subcutaneous tissue below the DH interface (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 Differentiationand.52.aspx).

[0125] Localized treatment of sweat glands with RF power, causing thermal damage or necrosis, is expected to improve hyperhidrosis. Microwave treatment without sweat gland localization has been shown 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 sweat gland localization involves heating most of the skin from the surface to the DH junction. Non-selective volumetric heating requires skin cooling and local injection of anesthetics for pain control. Using RF power to treat sweat glands locally avoids non-selective volumetric heating, improves safety and patient comfort, while maintaining or exceeding the efficacy of microwave treatment.

[0126] The epithelium or subcutaneous tissue is composed of adipose tissue. The dielectric properties of fat (for adipose tissue) are summarized in the following literature: Gabriel et al., “The dielecwic properties of biological tissues: I Literature survey, Phys. Med. Biol. 41 (1996) 2231-2249; and Gabriel S, Lau RW, 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, Grant EH. Electrical conductivity of tissue at frequencies below 1MHz Physics in medicine & Biology. 2009 Jul 27; 54 (16): 4863. The dielectric properties of artificial sweat (for human sweat) are summarized in Eldamak et al., “Study of the Dielectric Properties of Artificial Sweat Mixtures at Microwave”. The frequency of these events is summarized in Biosensors 2020, 10, 62. Figure 19 The relative permittivity and conductivity of sebum and artificial sweat at frequencies ranging from approximately 100 Hz to approximately 1 GHz were plotted. These precise values ​​may be updated when more accurate data on the dielectric properties of sebum and sweat become available; however, the general concept of locating sweat glands and performing RF processing based on their dielectric properties will remain unchanged.

[0127] A similar method described above for treating enlarged sebaceous glands can also be applied to treat excessive sweating. In the first diagnostic step, the sweat glands are located based on the difference in dielectric properties between sweat and fat. Furthermore, during the diagnostic step, due to the significant specific differences between fat and dermis, it is possible to determine whether the electrode is non-insulated and whether the energy delivery tip is located in the dermis or subepithelial fold. Figure 3 If the non-insulated tips of the electrodes are located in the dermis, they can be repositioned to penetrate the subcutaneous layer. Then, with the non-insulated tips of the electrodes in the subcutaneous layer, diagnostic methods using impedance variations of the electrode array will allow for the determination of the location and approximate size of the sweat glands.

[0128] In the second processing step, higher-energy processing pulses are delivered only to electrodes identified as being located inside or near sweat glands. Only a relatively small fraction of the electrodes in the array are close to the sweat glands, and when they are stimulated, only a small portion of the hypothalamus near these sweat glands is subjected to thermal damage.

[0129] Unwanted excessive sweating can often be a source of embarrassment and social anxiety. The ability to cosmetically treat sweat glands to remove or prevent unwanted sweating can help boost self-esteem and reduce embarrassment and social anxiety. Therefore, the cosmetic treatments for excessive sweating and other cosmetic procedures disclosed in this article offer numerous benefits and can help overcome ridicule and criticism from others in social situations.

[0130] Figure 19 This indicates the existence of a wide frequency range where the dielectric properties of fat and sweat differ by more than approximately 2, 5, or 10 times. Figure 20 and Figure 21 The resistivity amplitude |z| and phase angle θ of sweat and dermis, calculated for frequencies from approximately 100 Hz to approximately 1 GHz, are plotted above. The ratio of the resistivity amplitude and phase angle of sweat to that of fat is plotted on... Figure 22 superior. Figure 22 This indicates that, for frequencies from approximately 100 Hz to approximately 1 GHz, the specific impedance amplitude of sweat is approximately 1 / 10 that of fat. Delivering RF power in the range of approximately 100 Hz to approximately 1 GHz to electrodes identified as being close to the target sweat glands results in selective power delivery to the sweat glands, with the power density delivered to the surrounding fat being at most as low as approximately 1 / 10 of that. Excitation of the RF electrodes identified as being close to each sweat gland corresponds to a period of time corresponding to its thermal relaxation time. (R. Rox Anderson, “Selective Photothermolysis: Precise Microsurgery by Selective Absorption of Pulsed Radiation,” Science, Vol. 220, pp. 524-528.)

[0131] The applicator or handheld device disclosed herein, and its variants, can be combined with control circuitry to regulate and count the number of uses, thereby enabling tracking of exceeding processing limits and causing the handheld device to be deactivated directly or remotely by the supplier or control system.

[0132] This document describes systems and methods for using RF energy to treat patient skin (e.g., dermis and hypothalamus) or other target tissues at depths below the tissue surface. In various aspects, this teaching can provide non-invasive, cooling (or non-cooling) RF-based treatments to achieve one or more of the following: sebaceous gland treatment, acne treatment, sweat gland treatment, vascular treatment, spider vein treatment, gland damage / deactivation, skin tightening (improvement of laxity), cellulite treatment devices, removal of unwanted hair, and treatment for unwanted vascular damage, as examples of which are not limiting.

[0133] Figure 23 This is a block diagram illustrating the interaction of the control system with feedback regarding pre-treatment diagnosis, pre-treatment impedance mapping, and impedance assessment of the treated subject. Here, AC power is converted to DC voltage in an AC-to-DC converter. The DC voltage is delivered to an RF power amplifier and then forward through a patient isolator (e.g., the converter). Starting from the patient isolator, the RF power is then delivered to the handpiece / electrode and attached to the handpiece (e.g., Figure 14 Electrode arrays (see, for example, Figure 9 and Figure 14 The RF power is then delivered to the patient via needles in an electrode array. The RF power can be delivered in monopolar or bipolar mode, or a single system can be capable of delivering both monopolar and bipolar modes (e.g., the Potenza manufactured by Jeisys Medical, Inc.). TM RF microneedle systems combine 1 or 2 MHz of monopolar and bipolar RF in a single device. The electrodes in the electrode array are also referred to as needles and microneedles. RF power can be delivered to the patient at a relatively low level suitable for impedance diagnosis and / or impedance mapping, and this RF power ranges from about 1 nanowatt to about 10 watts. Alternatively, RF power can be delivered to the patient at a level suitable for treating conditions of interest such as acne, unwanted hair, excessive sweating, or unwanted vascular damage (e.g., unwanted blood vessels). The RF rate used for treatment ranges from about 1 milliwatt to about 10 kilowatts, or from about 100 milliwatts to about 500 watts.

[0134] Optionally, not shown in Figure A, the DC voltage proceeds through a DC-DC buck converter that controllably converts the supplied DC voltage to the desired RF frequency. The controlled DC voltage is then delivered to an RF power amplifier and proceeds through a patient isolator (e.g., a converter). From the patient isolator, the RF power is then delivered to the patient via the handheld device / electrode disclosed herein.

[0135] Impedance diagnosis / impedance mapping:

[0136] Still referencing Figure 23To perform impedance diagnosis / impedance mapping, a relatively low level of RF power is delivered to the patient via electrodes present on the handheld device. The control system provides control signals instructing the low-level RF power to be multiplexed through the electrode array present on the handheld device to the patient tissue being diagnosed / mapped. The control system collects impedance information from the patient tissue processing area via the received control signals, which are used to generate impedance diagnosis information or impedance mapping.

[0137] For example, when RF power is delivered to the patient at a relatively low level suitable for impedance diagnosis and / or impedance mapping, the RF power ranges from about 1 nanowatt to about 10 watts, and diagnostic scanning of the tissue area is achieved by measuring the impedance of each electrode or, alternatively, the impedance between each pair of electrodes using control signals collected by the control system.

[0138] Impedance values ​​are determined for most (if not all) of the electrodes or electrode pairs within the array of the handheld device. The relative accuracy of impedance mapping improves when more electrodes or electrode pairs are queried. High and / or low impedance values ​​from this diagnostic measurement can be excluded before establishing a baseline impedance for that specific tissue region. In one implementation, when an impedance value is determined to be high and / or low, the microneedles or micro-apertures associated with that high and / or low value are designated for subsequent therapeutic treatment, based on the indication of interest. In another implementation, once the baseline impedance is determined, the system subsequently revisits the high and / or low impedance values ​​and determines, based on, for example, the system's fundamental frequency, which impedance values ​​to query for therapeutic purposes.

[0139] Therapeutic treatment:

[0140] Still referencing Figure 23 Based on the impedance mapping of the patient tissue, a single electrode or a selected subset of single electrodes (in unipolar mode) or a subset of electrode pairs (in bipolar mode) on the handheld device is excited to therapeutically treat areas identified as benefiting from the desired treatment, as indicated by the impedance mapping of the patient tissue. To perform the therapeutic treatment, RF power is delivered to the patient via electrodes present on the handheld device. The control system provides control signals instructing the RF power to be multiplexed through an array of electrodes present on the handheld device to the previously impedance-mapped patient tissue. Based on the impedance mapping previously constructed using impedance data collected from the treated patient tissue area, the control system multiplexes the power via a single electrode (in unipolar mode) or certain electrode pairs (in bipolar mode) on the handheld device. For example, the RF power is delivered to the patient at a level suitable for treating conditions of interest such as acne, unwanted hair, excessive sweating, or unwanted blood vessels. The RF rate used for treatment ranges from about 1 milliwatt to about 10 kilowatts, or from about 100 milliwatts to about 500 watts.

[0141] Acne:

[0142] In one implementation, a selected subset of adjacent needles or electrode pairs is excited to therapeutically treat enlarged sebaceous glands (ESGs) with RF energy. Impedance mapping can be used to identify ESGs with relatively large or maximum diameters, and these mapped ESGs are then treated with an appropriate range of RF power and time for treatment. Impedance mapping can also be used to identify ESGs with the highest lipid concentrations between a pair of electrodes, and these mapped ESGs are then treated with an appropriate range of RF power and time for treatment. Relatively large ESGs will make the space between the needles appear to have relatively high lipid concentrations. In particular, these needles (in bipolar mode) can be excited approximately equal to the time interval of the thermal relaxation time of the tissue between each respective needle. In the case where a single needle (or a subset of single needles) is in direct contact with an ESG (in unipolar mode), each single needle can be excited approximately equal to the time interval of the thermal relaxation time of the tissue it contacts. For some treatment periods, selective RF heating, whether for needles (in bipolar mode) or single needles (in unipolar mode), requires high power for a short period.

[0143] Excessive sweating:

[0144] In one implementation, a selected subset of adjacent needles or electrode pairs is excited to therapeutically treat sweat glands with RF energy. The presence of sweat glands can be identified using impedance mapping, and then the selected subset of mapped sweat glands is treated using an appropriate range of RF power and time for treatment. Specifically, these needles (in bipolar mode) can be excited at a time interval approximately equal to the tissue's thermal relaxation time between each corresponding needle. For some treatment periods, selective RF heating will require short periods of high power. In one implementation, all sweat glands identified as present in the patient's tissue area are treated using an appropriate range of RF power and time for treatment.

[0145] Unwanted hair removal:

[0146] In one implementation, a selected subset of adjacent needles or electrode pairs is excited to therapeutically treat unwanted hair follicles with RF energy. Impedance mapping can be used to identify the presence of hair shafts within the follicles, and then the selected subset of these mapped follicles is treated with an RF power range and time suitable for the hair removal treatment. Specifically, these needles (in bipolar mode) can be excited at a time interval approximately equal to the tissue's thermal relaxation time between each respective needle. For some treatment periods, selective RF heating will require short periods of high power. In one implementation, all unwanted hair follicles identified as present in the patient's tissue area are treated using an RF power range and time suitable for treatment.

[0147] Unwanted blood vessels:

[0148] In one implementation, a selected subset of adjacent needles or electrode pairs is excited to therapeutically treat unwanted vessels with RF energy. Impedance mapping can be used to identify unwanted vessels by increasing blood volume fraction, and then these mapped unwanted vessels are treated using an appropriate range of RF power and time for treatment. Alternatively, impedance mapping can be used to identify unwanted vessels by increasing vessel fraction, and then these mapped unwanted vessels are treated using an appropriate range of RF power and time for treatment. In particular, these targets (in bipolar mode) can be excited approximately equal to the time interval of the thermal relaxation time of the tissue between each respective target. In the case where a single needle (or a subset of single needles) is in direct contact with an unwanted vessel (in unipolar mode), each single needle can be excited approximately equal to the time interval of the thermal relaxation time of the tissue it is in contact with. For some treatment periods, selective RF heating, whether by targets (in bipolar mode) or single needles (in unipolar mode), requires high power for a short period.

[0149] Generally, the methods and systems disclosed herein can be used to provide a variety of non-medical treatments, such as cosmetic treatments, aesthetic treatments, and combinations thereof. Cosmetic treatments of tissues to reduce or prevent excessive sweating, remove unwanted hair, remove blood vessels and lesions, and reduce or prevent acne are all beneficial cosmetic treatments. These and other cosmetic treatments disclosed herein can improve the appearance and health of individuals suffering from the aforementioned conditions and other conditions disclosed herein. In various embodiments, this disclosure relates to methods of controlling RF energy delivery such that one or more tissue targets are cosmetically treated to reduce, prevent, reverse, or otherwise cosmetically treat one or more unwanted conditions disclosed herein.

[0150] Further details relating to the various systems that use RF and impedance sensing to treat tissues are disclosed in U.S. Publication No. 20200352633 entitled “NON-INVASIVE, UNIFORM AND NON-UNIFORM RF METHODS AND SYSTEMS RELATED APPLICATIONS”, the entire contents of which are incorporated herein by reference.

[0151] Furthermore, additional details relating to various systems used for processing tissues using RF and impedance sensing are disclosed in U.S. Publication No. 20190239939 entitled “METHODS AND APPARATUS FOR CONTROLLED RF TREATMENTS AND RF GENERATOR SYSTEM”, the entire disclosure of which is incorporated herein by reference.

[0152] It should be understood that, for clarity, the following discussion will explain various aspects of the implementations taught by the applicant, while omitting certain specific details where convenient or appropriate. For example, the discussion of similar or analogous features in alternative implementations may be simplified. For brevity, well-known ideas or concepts may also not be discussed in detail. Those skilled in the art will recognize that certain implementations taught by the applicant may not require certain details specifically described in each implementation; these details are set forth herein merely to provide a thorough understanding of the implementations. Similarly, it will be apparent that the described implementations may be readily altered or varied based on common general knowledge without departing from the scope of this disclosure. The following detailed description of the implementations should not be construed as limiting the scope of the applicant's teachings in any way.

[0153] As used herein, the terms “about” and “substantially the same” refer to variations in numerical quantities that can occur, for example, through: real-world measurement or processing procedures; through negligence or errors in such procedures; through differences / failures in the manufacture of electrical components; through electrical losses; and variations that are considered equivalent by those skilled in the art, provided that such variations do not include values ​​known in prior art practice. Typically, the term “about” means greater than or less than a specified value or a range of 1 / 10 of a value, such as ±10%. For example, applying about +3V DC to an element may mean a voltage between +2.7V DC and +3.3V DC. Similarly, when values ​​are referred to as “substantially the same,” these values ​​may differ by up to 5%. Whether modified by the terms “about” or “substantially the same,” the quantitative values ​​recited in the claims include equivalents to the recited values, such as variations in the numerical quantities of these values ​​that are considered equivalent by those skilled in the art.

[0154] Furthermore, nothing disclosed herein is intended to be offered to the public, whether or not such disclosure is expressly stated in the claims. In order to assist the Patent Office and any reader of any patent issued under this application in interpreting the appended claims or otherwise brought in throughout the proceedings of this patent application or any ongoing patent application, the applicant wishes to note that they do not intend to interpret any claimed feature in accordance with or otherwise invoke 35 USC 112(f) unless the phrase “means” or “step” is expressly used in a particular claim.

[0155] All accompanying figures include one or more decorative features and views, each including solid lines, wherein any of them also includes and corresponds to dashed lines and provides support for dashed lines, and alternatively, each including dashed lines, wherein any of them also includes and corresponds to solid lines and provides support for solid lines.

[0156] Unless otherwise expressly stated, the use of the terms “include,” “includes,” “including,” “have,” “has,” or “having” should generally be understood as open-ended and non-restrictive.

[0157] Unless otherwise expressly stated, the singular as used herein includes the plural (and vice versa). Furthermore, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly specifies otherwise. Additionally, where the term “about” precedes a quantitative value, this teaching also includes the specific quantitative value itself, unless otherwise expressly stated.

[0158] It should be understood that the order of steps or the sequence of actions is irrelevant, as long as this teaching remains operational. Furthermore, two or more steps or actions can be performed simultaneously.

[0159] When a list of ranges or values ​​is provided, each intermediate value between the upper and lower limits of that range or list of values ​​is considered individually and included within this disclosure as if each value were specifically listed herein. Furthermore, smaller ranges between and including the upper and lower limits of a given range are considered and included within this disclosure. The list of exemplary values ​​or ranges is not a disclaimer regarding other values ​​or ranges between and including the upper and lower limits of a given range.

[0160] It should be understood that various changes can be made to the disclosed embodiments without departing from the scope of this teaching. Although the foregoing figures and examples involve specific elements, they are intended to be illustrative and not limiting. Those skilled in the art will understand that various changes in form and detail can be made to the disclosed embodiments without departing from the scope of the teachings covered by the appended claims.

Claims

1. A system comprising: The applicator includes: Electrode assembly, including: Substrate, and A needle array comprising multiple needles extending from a substrate, the needles being arranged according to a pattern; and A handheld device connected to the electrode assembly; and A control system electrically connected to the plurality of needles; The control system is configured as follows: In response to detecting the location of enlarged sebaceous glands using impedance data measured by two or more of the plurality of needles, Stimulate one or more of the plurality of needles to treat the enlarged sebaceous gland; A series of low-power pulses are sent through each of the plurality of needles; Collect impedance data associated with each of the plurality of needles. Until the collected impedance data show a contrast indicating the presence or absence of enlarged sebaceous glands, The collected impedance data showed contrast, indicating that normal-sized sebaceous glands were exempt from targeted energy exposure.

2. The system according to claim 1 further includes an RF power amplifier electrically connected to the plurality of pins, wherein, The RF power amplifier generates one or more RF signals to excite one or more of the plurality of needles.

3. The system according to claim 1, wherein, The pattern comprises hexagonal clusters of needles, with at least one needle disposed within each such cluster.

4. The system according to claim 1, wherein, The enlarged sebaceous glands have a diameter greater than approximately 50 μm.

5. The system according to claim 1, wherein, To detect the location of the enlarged sebaceous glands, the control system is further configured to: Based on the collected impedance data, it is determined which of the plurality of needles is near the enlarged sebaceous gland.

6. The system according to claim 5, wherein, The series of low-power pulses is sent repeatedly.

7. The system according to claim 1, wherein, To stimulate one or more of the plurality of needles, the control system is also configured to send energy through the needles located near the enlarged sebaceous glands.

8. The system according to claim 1, wherein, One or more needles include a liquid delivery port and a channel for receiving the solution.

9. The system according to claim 8, wherein, The solution is a conductive solution.

10. The system according to claim 1, wherein, The control system is also configured to address one or more of a plurality of needles according to an excitation scheme such as a multiplexed sequence.

11. The system according to claim 1, wherein, Normal-sized sebaceous glands are protected from targeted energy exposure.

12. The system according to claim 1, wherein, Detecting the location of enlarged sebaceous glands also includes performing impedance mapping associated with the treatment area.

13. The system according to claim 1, wherein, Detecting the location of enlarged sebaceous glands also includes identifying the enlarged sebaceous glands in response to one or more impedance measurements obtained during impedance mapping.

14. The system according to claim 1, wherein, Detecting the location of enlarged sebaceous glands also involves measuring the impedance difference between two adjacent needles that cross the sebaceous gland.

15. The system according to claim 1, wherein, The control system is also configured to perform diagnostic impedance measurements related to the target area.

16. The system according to claim 15, wherein, The control system is also configured to exclude high and / or low impedance values ​​from diagnostic impedance measurements.

17. A system comprising: The applicator includes: Electrode assembly, including: Substrate, and A needle array comprising multiple needles extending from a substrate, the needles being arranged according to a pattern; and A handheld device connected to the electrode assembly; and A control system connected to multiple needles, wherein the control system is configured to detect the position of a tissue target, and the control system is configured as follows: The location of the enlarged tissue target is detected in response to impedance measured using two or more of the plurality of needles. Stimulate one or more of the plurality of needles to cosmetically treat one or more portions of an enlarged tissue target; A series of low-power pulses are sent through each of the plurality of needles; Collect impedance data associated with each of the plurality of needles. Until the collected impedance data show contrast indicating the presence or absence of an increased tissue target, The collected impedance data showed contrast, indicating that normal-sized tissue targets were spared from targeting energy exposure.

18. The system according to claim 17, wherein, Tissue targets are selected from hair follicles; sweat glands, vascular damage, blood vessels and sebaceous glands.

19. The system according to claim 17, wherein, In order to detect the location of the tissue target, the control system is also configured to: Send a low-power pulse through each of the multiple needles; Collect impedance data associated with each of the multiple needles; as well as Based on the collected impedance data, it is determined which of the multiple needles is near the tissue target.

20. The system according to claim 17, wherein, In order to detect the position of the tissue target, the control system is also configured to measure the impedance difference between two adjacent needles that cross the tissue target.

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