System and method for skin rejuvenation using impedance monitoring

Abstract

The present disclosure relates, in part, to a method of cosmetic tissue treatment. The method includes disposing a treatment applicator including an electrode array having a plurality of needles on a portion of tissue such that a region of the electrode array contacts the portion of tissue, wherein each needle is an electrode in electrical communication with a control system; applying a pulse of radiofrequency (RF) energy to the portion of tissue through the electrode array; measuring impedance of the electrode array over time; detecting a decrease in the measured impedance when the electrode array is in contact with the portion of tissue; and terminating the application of the pulse of RF energy after a treatment period upon detecting a threshold decrease in impedance.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority and benefit to U.S. Provisional Patent Application No. 63 / 024,483, filed May 13, 2020, entitled “System and Method for Skin Rejuvenation Using Impedance Monitoring,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to systems and methods for treating a patient’s skin (e.g., dermis and subcutaneous tissue) and other target tissues using radio frequency (RF) energy. Background Technology

[0004] Electrosurgical devices are known to apply RF energy to tissue to produce a variety of effects, including invasive procedures (e.g., for ablation or vaporization of tissue) or less invasive procedures (e.g., for gently heating the surface of the skin). However, there remains a need for methods and systems to deliver RF energy in cosmetic and / or aesthetic applications, such as to improve the appearance of the skin, thereby improving the skin's (or making it appear) firmer / smoother. Summary of the Invention

[0005] In various embodiments, this disclosure relates to systems and methods for processing tissue. A processing apparatus is activated, and RF energy is delivered to the tissue via one or more electrodes. Impedance is monitored during one or more time periods associated with the processing, such as before, during, and after processing, and during subsets thereof. Impedance monitoring is performed during periods of increasing impedance values, which are associated with tissue transformation such as tissue removal. Impedance monitoring is also performed during periods of decreasing impedance. The impedance decrease after the start of processing is associated with one or more electrodes transmitting a signal indicating the impedance decrease, which is due to contact with another region or volume of tissue that has different characteristics relative to the transformed tissue, such as a previously untouched layer of hydrated tissue or tissue having another characteristic associated with lower impedance, lower resistance, or increased conductivity. In various embodiments, processing is stopped, such as by stopping the delivery of RF energy, after the processing time period measured from when the aforementioned impedance decrease was detected.

[0006] This disclosure relates in part to a method for treating cosmetic tissue. The method includes placing a treatment applicator comprising an electrode array containing multiple needles on a portion of tissue such that a region of the electrode array contacts the portion of the tissue, wherein each needle is an electrode electrically connected to a control system; applying radio frequency (RF) energy pulses to the portion of the tissue through the electrode array; measuring the impedance of the electrode array over time; detecting a decrease in the measured impedance when the electrode array contacts the portion of the tissue; and terminating the application of the RF energy pulses after a treatment period when an impedance reduction threshold is detected.

[0007] In one embodiment, the duration of the pulse is between about 1 ms and about 12 ms. In one embodiment, impedance is measured at a sampling rate ranging from about 10 kHz to about 50 kHz. In one embodiment, impedance is measured at a sampling rate of about 30 kHz. In one embodiment, the method further includes avoiding inducing muscle spasms during the treatment period, and optionally, the electrode array has an output voltage with a ramp time ranging from about 100 ms to about 5 ms. In one embodiment, multiple electrodes are connected in parallel. In one embodiment, the method includes transforming tissue such that tissue is removed near a subset of contacts with the multiple electrodes. In one embodiment, the method further includes applying a topical agent to a portion of the tissue before setting the treatment applicator. In one embodiment, the method further includes applying a topical agent to a portion of the tissue after the treatment period. In one embodiment, the method further includes applying a topical agent to a portion of the tissue before and after the treatment period. In one embodiment, the topical agent is a skin moisturizer. In one embodiment, the RF energy pulse travels along the electrode surface and induces a tissue effect upon reaching a portion of the tissue. In one implementation, one or more ring-shaped lesions are generated in the tissue in response to a radio frequency (RF) energy pulse.

[0008] This disclosure relates in part to an apparatus for treating tissue. The apparatus includes a first treatment applicator head including a first plurality of needles; and an applicator body having a first end connected to the first treatment applicator head; wherein the applicator body includes a second end in communication with a radio frequency (RF) power supply and a control system; wherein the first treatment applicator head is electrically connected to the RF power supply when connected to the applicator body, the RF power supply being in communication with the second end; wherein the control system is operable to terminate tissue treatment after a treatment period occurs, the treatment period being initiated upon detection of an initial increase in impedance followed by a decrease in impedance. In one embodiment, each of the plurality of needles has a blunt tip. In one embodiment, the apparatus further includes a second treatment applicator head including a second plurality of needles, the first end of the applicator body being connected to the second treatment applicator head, wherein the second treatment applicator head is electrically connected to the RF power supply when connected to the applicator body.

[0009] This disclosure relates in part to a method of processing tissue, the method comprising applying radio frequency (RF) power to the tissue via a plurality of electrodes; periodically measuring the impedance of the tissue during the application of the RF power; and controlling the application of the RF power based on the impedance of the tissue such that processing is terminated upon a measured decrease in the impedance. In one embodiment, the decrease in the measured impedance is associated with one or more of the plurality of electrodes contacting an untreated region of the tissue. In one embodiment, a first conductivity characteristic of the untreated region of the tissue differs from a second conductivity characteristic of a treated region of the tissue. In one embodiment, the treated region of the tissue is positioned above the untreated region of the tissue. In one embodiment, the RF power is reduced when a decrease in the impedance of the tissue is detected. In one embodiment, the processing time for the RF power application ranges from about 1 ms to about 12 ms. In one embodiment, the decrease in the measured impedance ranges from about 10% to about 90%. In one embodiment, the decrease in the measured impedance ranges from about 20% to about 50%.

[0010] Although this disclosure relates to different aspects and embodiments, it should be understood that the different aspects and embodiments disclosed herein can be integrated, combined, or used together as a combined system, or, where appropriate, partly as separate components, devices, and systems. Therefore, each embodiment disclosed herein can be incorporated into each aspect to varying degrees for a given implementation, as appropriate. Furthermore, the various systems, probes, applicators, needle arrays, controllers, components, and portions described above can be used with any suitable tissue surface, cosmetic application, medical application, and other methods, and can be used in conjunction with other devices and systems without limitation.

[0011] These and other features of the applicant's teachings are described in this document. Attached Figure Description

[0012] This patent or application document contains at least one color drawing. The Patent Office will provide a color copy of this patent or patent application publication upon request and payment of the necessary fees.

[0013] Unless otherwise stated, the accompanying drawings illustrate aspects of the innovations described herein. Referring to the drawings, where like numerals refer to like parts in several views and throughout this specification, several embodiments of the currently disclosed principles are shown by way of example rather than limitation. The drawings are not intended to be drawn to scale.

[0014] Figure 1A This is a diagram illustrating an RF non-penetrating needle / electrode in contact with tissue according to an embodiment of the present disclosure.

[0015] Figure 1B This is a diagram illustrating the formation of annular damage and the associated RF electrodes / pins after RF energy transmission according to an embodiment of this disclosure.

[0016] Figure 1C This is a diagram illustrating a first applicator and a second applicator with different electrode array configurations according to embodiments of the present disclosure.

[0017] Figure 2A-2D This is a diagram showing different views of the processing applicator / probe and its components according to embodiments of the present disclosure.

[0018] Figure 3A This is an alternative perspective view of the body of a treatment applicator suitable for tissue treatment according to an embodiment of the present disclosure.

[0019] Figure 3B These are images showing an exploded view of some exemplary components of the applicator head according to an embodiment of the present disclosure.

[0020] Figure 4 This is a diagram of a metal conductive pin / needle electrode in an applicator, according to an embodiment of the present disclosure.

[0021] Figures 5A-5C This is a simplified illustration of an electrode array from a treatment applicator that applies RF energy to the skin, according to an embodiment of the present disclosure.

[0022] Figure 6 This is a diagram showing the electrical signals before, after, and during tissue processing using a processing applicator, according to an embodiment of the present disclosure.

[0023] Figure 7-10It is a graphical display diagram depicting electrical signals including current, impedance, and voltage during various time periods during tissue treatment using RF energy applied by a treatment applicator, according to embodiments of the present disclosure.

[0024] Figure 11A According to an embodiment of this disclosure, an organization processes a first photographic image of the organization after using a processing applicator to process the processing duration determined using impedance monitoring.

[0025] Figure 11B According to an embodiment of this disclosure, the organization takes a second photographic image after processing the organization for a period of time less than the recommended processing duration using a processing applicator.

[0026] Figure 12A The image is a histological image of tissue obtained from a first region after applying a moisturizer before processing with an RF on-time of approximately 3 ms, according to an embodiment of the present disclosure.

[0027] Figure 12B The image is a histological image of tissue obtained from a first region after applying a moisturizer before processing with an RF on-time of approximately 5 ms, according to an embodiment of this disclosure.

[0028] Figure 13 This is a schematic diagram of an RF-based system applicable to the control and transmission of power and RF energy according to an illustrative embodiment of the present disclosure. Detailed Implementation

[0029] This disclosure relates in part to systems, apparatus, and methods for directing and / or delivering electromagnetic energy, such as radio frequency (RF) energy, to one or more tissue regions, volumes, or layers to alter the aforementioned tissue through one or more mechanisms of action, thereby directly or indirectly producing or inducing cosmetic, restorative, and / or other tissue changes. Examples of other tissue alterations or transformations that can be induced or induced using the applicators and methods disclosed herein may include stimulating, repairing, and / or growing tissue or one or more of its components through mechanisms such as fractional rejuvenation or others. In one embodiment, RF treatment alters tissue by increasing collagen production. The treatment applicator may also be referred to as a probe or RF treatment device, and as otherwise mentioned herein.

[0030] Unbound by any specific theory or mechanism, this pin / needle-based electrode array application can use electrical signals, rather than optical signals such as lasers, to transform tissue. Specific types of tissue transformation and effects generated or induced during a given treatment segment can include, but are not limited to, ablation, tissue removal, cauterization, plasma generation, RF-induced plasma generation, non-thermal RF-induced pressure waves, tissue carbonization, tissue vaporization, mechanical changes in tissue, damage formation, void formation, tissue excavation, increased production of tissue compounds, tissue scarring, and combinations thereof. The given tissue transformation is customized on a per-user basis using treatment time adjusted by monitoring impedance changes.

[0031] Figure 1A The diagram illustrates an RF tissue contact non-penetrating needle / electrode N being pushed against a tissue surface such as skin. RF energy from the outer surface of the needle / electrode N propagates along the outer surface of the needle / electrode N and comes into contact with the tissue surface.

[0032] Figure 1A This illustrates how the outer surface of the needle / electrode N and the RF transmitted therefrom induce the skin effect in one or more regions near or in contact with the electrode. The skin effect is the tendency of alternating current (AC) within a conductor to result in a maximum current density near the conductor surface, decreasing exponentially with increasing conductor depth. Current flows primarily at the conductor's "skin," between the outer surface and a level known as the skin depth. The skin depth depends on the frequency of the AC; as the frequency increases, current flow shifts towards the surface, causing the skin depth to decrease. (Still referencing...) Figure 1A The electroskin effect is caused by the distribution of alternating current (AC) within a conductor, which tends to maximize the current density near the conductor surface and decrease exponentially with increasing conductor depth. In various embodiments, the conductor surface corresponds to the surface of the needle / electrode N. This electroskin effect is proportional to the frequency of the AC. In one embodiment, the needle / electrode N receives RF generated using an AC generator with a frequency ranging from about 0.5 MHz to about 4 MHz. In various embodiments, the aforementioned selection of the high-frequency range increases the intensity of the electroskin effect generated by the needle / electrode N. The electroskin effect imparts a tissue effect on the skin surface (e.g., the superficial skin region).

[0033] like Figure 1AAs illustrated, when such contact is established by pushing or otherwise deflecting or penetrating one or more non-penetrating needles / electrodes N toward or into the skin, the RF energy tends to initially meet the surface of the tissue. When the RF energy meets the skin tissue surface, damage is formed around the outer surface of the needle / electrode N. In various embodiments, this damage occurs at the point where the RF energy meets the skin surface. The resulting skin-effect damage is initially concentrated around the junction between the outer surface of the needle / electrode N and the skin surface.

[0034] Turning Figure 1B In embodiments where the needle / electrode N has a circular cross-section, annular lesions can be created on the skin / tissue surface (e.g., Figure 1B (As shown in the diagram). The annular damage caused by such a needle / electrode N causes the RF energy to concentrate at the junction of the outer surface of the needle / electrode N and the skin surface in response. The damage is geometrically annular, at least in part, because the tip of the non-penetrating needle / electrode N vaporizes and / or ablates the surface of the tissue it contacts. The tip of the needle / electrode N effectively serves as the RF focus for the RF energy along the surface of the needle / electrode N. The RF energy propagates to adjacent tissue surfaces, where one or more tissue injuries are generated.

[0035] like Figure 1B As shown, the area at the bottom or low point LP of the crater W is exposed to the dermis or epidermal / dermal junction due to tissue damage generated by the response to RF transmission through the needle / electrode N. One or more heat-affected zones TZ may also be due to the transmission of RF energy and associated skin effects, where the RF energy travels along the surface of the conductive needle / electrode N before propagating through the tissue from the dotted tip of the needle / electrode N to the low point LP.

[0036] Ablation of tissue in contact with the tip of a non-penetrating needle / electrode N creates a hole (or pit or depression) W in the tissue. Furthermore, the surface of the hole or pit W created by electrode N is ablated / vaporized. This ablation / vaporization exposes the tissue beneath the surface, such as dermis and / or epidermal / dermal junction tissue, while simultaneously contributing to or causing the appearance of the hole or pit W. The exposed tissue around the bottom of the pit W is relatively undamaged (e.g., with minimal thermal effect). RF treatment using electrode N effectively exposes one or more portions of tissue by ablation and / or vaporization of tissue previously covering the exposed tissue. The newly exposed tissue may absorb and / or retain the topical treatment.

[0037] In various embodiments, topical creams or other agents can be applied to tissues exposed or exposed due to the transmission of RF energy as described herein. Various topical products suitable for application to exposed or exposed tissues are discussed in detail herein. For example, certain topical products (e.g., hydrophilic, hydrophobic) may preferably be used for tissues exposed by RF energy transmission. Figure 1BThe RF treatment shown in the image provides damage to the non-penetrating needle electrode N. Certain external materials are expected to be suitable for use in... Figure 1B The damage shown in other aspects disclosed herein undergoes improved absorption and / or retention. As discussed herein, the choice of fundamental frequency can determine the extent of thermal effects in the treated area, thus allowing the skin effect to be utilized with a higher fundamental frequency (e.g., from about 1 kHz to about 1 GHz). Conversely, a relatively lower fundamental frequency (e.g., from about 100 Hz to about 1 kHz) can achieve a uniform thermal effect.

[0038] Skin rejuvenation treatments typically use laser ablation, which can be a complex and expensive procedure. Generally, RF treatments are advantageous in terms of lower costs and the availability of less damaging or more readily available components. Unfortunately, the various methods of applying RF energy have their drawbacks. For example, some treatment systems have attempted to use long-duration pulses with low RF energy. Long-duration pulses with low RF energy result in higher residual heat retention in the skin. Managing residual heat is generally difficult because individual skin varies, and excessive heat can lead to pain and unpredictable outcomes.

[0039] The amount of RF energy required to treat different individuals depends on many variables (e.g., the amount of pigmentation and hydration level of an individual's skin). To help address some of these technical challenges, the systems and methods disclosed herein have been adapted to provide cost-effective and customized, user-specific methods for skin rejuvenation or other treatment of individual tissues. In part, the subject-specific nature of the treatment can be achieved by incorporating impedance monitoring as a mechanism to tailor the treatment time on a per-individual basis.

[0040] In various embodiments, this disclosure describes a system including a control and / or analysis system connected to a processing applicator. The control and / or analysis processing system includes one or more ASICs, circuits, microprocessors, or other control systems that stop the transmission of RF energy after detecting / measuring an impedance value or threshold or an impedance transition and / or after a predetermined time period following such detection.

[0041] In various embodiments, the treatment applicator includes a treatment applicator head having a group of electrodes arranged in a pattern. The treatment head may be removable / releasable relative to the probe / applicator body. The electrodes are conductive pins or needles or other protrusions extending from a conductive surface or otherwise electrically connected to an analytical and control processing system. In some embodiments, the electrodes of the treatment applicator are arranged in a pattern such as a regular polygon or other shape, with the electrodes positioned at their vertices and / or centered relative to such a polygon or other shape. For example, in one embodiment, the treatment applicator includes about 50 electrodes or applicator needles, wherein the electrodes are arranged in rows of about 10 electrodes. In this embodiment, the electrodes are evenly spaced within the tissue contact area of ​​the treatment applicator.

[0042] Figure 1C Two different applicators A1 and A2 are shown. The first applicator A1 has a single array of non-penetrating needle electrodes (e.g., pins). A given array may be supported by or connected to a first applicator head. In one embodiment, a single array of applicator A1 has an area of ​​approximately 1 cm × approximately 1 cm. Various applicator embodiments may have two or more applicator heads. The second applicator A2 has four separate arrays of approximately 1 cm × approximately 1 cm, positioned at the four corners of a square or rectangle on the applicator surface, such that the total pin coverage is approximately 2 cm × approximately 2 cm. Each array or array combination may be part of one or more applicator heads connected to the applicator body. Multiple applicators may also be used in different embodiments.

[0043] In various implementations, the number of non-penetrating needle electrodes (e.g., pins) in any array and / or any applicator is limited by the distribution of the number of pins in each array to maintain uniform energy deposition for each needle. When the number of pins in the array exceeds this permissible threshold, the desired processing uniformity decreases, resulting in uneven energy distribution. The factors determining the permissible threshold for the number of pins in the array vary from applicator to applicator. These factors may include needle diameter, spacing between adjacent needles, needle material, frequency, mode (bipolar or monopolar), time, etc. Each applicator A1, A2 includes a handle, actuator, and wire, whether it has one array or multiple arrays. Each wire connects its applicator to an RF generator and one or more control systems.

[0044] When multiple arrays are used, the arrays do not need to be activated simultaneously, but they can be activated sequentially in time to distribute the same power to the smaller array units in a short sequence representing a single activation of the RF handheld device. A single activation, created by sensing automatic contact between the pins and tissue via, for example, a foot switch, a manual switch, or impedance monitoring when the arrays make contact, can pulse each array to represent a covered area larger than a single pulse of a single array. Since the pulse duration is on the order of milliseconds, and the timing between pulses can be less than one millisecond, theoretically the device can cover many square centimeters with a single pulse activation and is still considered a short pulse (<100ms), suitable for manual imprinting techniques. In one embodiment, an RF pulse of approximately 3ms duration can be used to power the array of applicator A1. In one embodiment, an RF pulse of approximately 3ms duration can be used to power the array of applicator A2 simultaneously or in an alternating pattern such as a cyclic scheme. In one embodiment, applicator A2 has a total power-on time of approximately 12ms, powering each of the four arrays for approximately 4ms.

[0045] Application array selection in the processing area

[0046] The applicator array can be configured to conform to the surface curvature shape of the treatment area. Applicators with a conformal surface shape are advantageous because they can apply uniform electrode pressure to the underlying skin. The uniform electrode pressure of a conformal applicator is expected to result in more consistent and predictable treatment outcomes. Each array element can be rigid, but can also employ a suspension to precisely maintain perpendicularity to the curved tissue plane. Examples of such mechanisms can be seen in electric shavers, where each cutting head conforms to the tissue surface via a suspension mechanism with a load-bearing spring. Various array shapes suitable for specific anatomical regions can be envisioned, such as around the nose; the upper lip, etc.

[0047] Row and column configuration

[0048] In various embodiments, the delivery electrodes can be positioned on a hexagonal or rectangular grid. A hexagonal arrangement offers the advantage of the most uniform distance between the electrodes and their nearest neighbors, and a correspondingly uniform biological effect of the treatment. Alternatively, in various embodiments, a non-uniform spacing between the delivery electrodes may be beneficial if the desired biological effect has a preferred orientation. For example, for skin tightening treatments, a higher density of delivery electrodes in the desired tightening direction and a lower density in the lateral direction may be beneficial to optimize tissue heating and healing time for maximum tightening effect in that direction with minimal healing time and minimal side effects.

[0049] cross-section of the pin

[0050] The cross-section of each pin or transmission electrode can be of any geometry, which results in the blunt tip of the pin pressing against the skin. The blunt tip is preferred such that when the pin array is pressed against the skin, the pin does not penetrate the epidermis before RF energy transmission. This arrangement optimizes high RF power density transmission in the epidermis and lower RF power density transmission in the dermis. The skin surface contact area of ​​the blunt tip is optimized for sufficiently high RF power density transmission to induce the tissue effects and impedance changes described in this application.

[0051] Apply topical products before / after using the applicator.

[0052] Topical formulations can be applied to the skin before and / or after RF power transmission. If applying each specific topical formulation before RF power transmission is considered, the effect of the formulation on the impedance of the transmission electrode and / or the underlying skin region must be evaluated for those specific formulations. If applying each specific topical formulation before RF power transmission is considered, the formulation that may undergo chemical, physical, or structural changes during RF power transmission must be evaluated for those specific formulations. For topical formulations applied to the skin after RF power transmission, impedance or RF heating is not considered. In some embodiments, the topical formulation can be applied to the skin at a predetermined dose via an RF treatment applicator before and / or after RF power transmission.

[0053] Applicator processing scheme / timing

[0054] The treatment process can be conceived as a first treatment, optionally followed by multiple treatments at intervals between approximately 1 week and approximately 3 months. Multiple treatments with relatively low RF power levels and / or short power delivery durations will preferably be delivered at shorter intervals, such as approximately 1 to approximately 3 weeks. Multiple treatments with relatively high RF power levels and / or longer power delivery durations will preferably be delivered at longer intervals, such as approximately 3 weeks to approximately 3 months. A treatment process can also be employed, as described below, wherein the RF power level and / or power delivery duration are maintained for each subsequent treatment during the subject treatment protocol.

[0055] The treatment applicator is capable of inducing a pattern shift of tissue, such as lesions or voids, relative to tissue such as the epidermis, for example, across a treatment area on or within the subject. Tissue is removed from the vicinity of an area or volume in contact with one or more surfaces of a given pin or needle of the applicator. Each lesion is created by a corresponding electrode within an electrode pattern within the treatment applicator. Each electrode receives a short burst of high RF energy from a controller and / or analysis system. The lesions are spaced apart such that each lesion is surrounded by undamaged tissue.

[0056] In these cases, undamaged tissue helps support the repair of adjacent portions of the damaged tissue, which promotes faster healing and / or repair of the damaged portion of the tissue. In various embodiments, the fractional pattern can be varied to cover treatment areas of different sizes. In some embodiments, the treatment applicator can cover multiple treatment areas. In these embodiments, one or more of the multiple treatment areas can be treated simultaneously or sequentially to effectively treat a larger portion of the skin. Multiple applicators or padding devices comprising pin / needle arrays can also be used.

[0057] In various embodiments, the treatment applicator creates a matrix of lesions. For example, a given lesion extent can be about 100 micrometers wide to about 300 micrometers wide. Similarly, a given lesion extent can be about 50 micrometers deep to about 300 micrometers deep. However, in other embodiments, the size of each lesion can be adjusted in response to the power level or duration applied by each electrode. The aforementioned depth and width ranges can be expanded or reduced by a factor of about 0.1 to about 10. For a given treatment segment, the RF power and / or duration can be varied as needed to increase the size and / or depth of the lesion. In some cases, the treatment applicator can be used to create larger lesions, deeper channels, or lesions of different sizes. In some embodiments, the size and / or shape of each electrode can be varied to select and / or adjust the size and / or depth of the lesions created. In a given treatment segment, in addition to RF energy delivery, the operator of the treatment system can apply downward pressure to push the needle / pin array into the tissue being treated.

[0058] In various embodiments, the treatment applicator includes one or more sensors to detect various changes within the skin during treatment. For example, in one embodiment, the treatment applicator includes an impedance sensor for detecting skin impedance at the contact point between the electrode and the skin. In this embodiment, the treatment applicator is capable of obtaining high-frequency sensor measurements. In one embodiment, the applicator does not include a sensor, and impedance measurements are performed at the treatment system using an input signal to the applicator and return signals that change during, before, and after treatment, such as an increase in impedance value, a substantially constant value, and a decrease. For example, in one embodiment, the treatment applicator can record measurements at a sampling rate of about 30 kHz. In various embodiments, the control system includes measurement circuitry operable to measure impedance values ​​at sampling rates ranging from about 20 kHz to about 50 kHz. In one embodiment, the sampling rate ranges from about 1 kHz to about 1 MHz. In some embodiments, the treatment applicator or treatment system is capable of varying the number of measurements that can be performed, making the sampling rate user-selectable.

[0059] Typically, an increase in impedance is expected during the application of RF energy through one or more electrodes in an array. Once the skin layer is ablated, carbonized, and / or vaporized during treatment, the expected outcome is indicated by the presence of gaps or obstructions. This gap relative to the electrode positioning results in increased impedance. Typically, once cells are removed from the tissue, vaporization / vaporization obstructions or air gaps arise between the tissue and the electrode tips, causing increased impedance. This is an expected outcome.

[0060] Unexpectedly, during the process, while the detected impedance increases with the start of treatment, the impedance measured during product progress decreases once the electrodes within the treatment applicator damage the outer layer of tissue, such as skin. This impedance decrease is an unexpected result. Instead of creating an obstruction or air gap between the skin and the electrodes, the healthy and hydrated skin beneath the electrodes has a lower measured impedance than the removed skin layer. This unexpected result provides a mechanism for impedance monitoring and customized treatment based on such monitoring. In various embodiments, processing is stopped in response to the decrease in measured impedance following the initial impedance increase during the RF transmission processing segment.

[0061] In various embodiments, the processing applicator is connectable to a controller and / or analysis system that provides RF power to the processing applicator. In at least one embodiment, the controller and / or analysis system can provide RMS (root mean square power) between about 150 and about 500 volts. The controller and / or analysis system is operable to provide a configurable amount of RF power to the processing applicator. In various embodiments, the controller system receives sensor data from the processing applicator to determine when to turn off or ramp down the RF power. In various embodiments, impedance can be used to determine whether processing is complete.

[0062] Once the treatment applicator penetrates the outer layer of skin using RF energy, the measured impedance decreases, indicating that the treatment applicator has contacted healthy / untreated tissue. Prior to this, impedance increases during the ramp-up phase. In some embodiments, the system is operable to measure impedance values ​​at high rates, such as about 30 kHz. In various embodiments, impedance is measured at the contact point between the pin electrode and the tissue being treated. In various embodiments, impedance measurements are performed in parallel for all tissue contact electrodes in a given array. As RF energy is applied to the tissue, the tissue's impedance level increases until the tissue is ablated, carbonized, and / or removed from the energy source or undergoes another transformation disclosed herein.

[0063] Not bound by any specific theory or mechanism, impedance levels can increase due to RF energy heating or drying of tissue. Tissue dehydration may be the cause of the initial increase in impedance. In this embodiment, once the treatment applicator contacts the untreated tissue layer, beneath the treated tissue layer, the impedance level decreases in response to a healthy tissue layer having greater conductivity relative to the impedance during treatment of the layer transitioned by RF transmission. In some cases, the greater conductivity is due to increased hydration of the skin. In at least one embodiment, the controller system shuts off the RF energy when the amount of impedance decreases by a certain percentage, threshold, or other value. In various embodiments, the decrease threshold is configurable. In some embodiments, the decrease threshold (see...) Figure 9 and 10 ) can be configured based on differences between patients (e.g., amount of skin pigmentation, age, skin hydration, etc.). These impedance variations can be observed in Figure 6-10 The chart / figure.

[0064] Figure 2A-2D This is a schematic diagram of an applicator 5 suitable for directing electromagnetic energy, such as radio frequency (RF) energy, to various tissues of a subject. The applicator can be used for skin rejuvenation treatments, cosmetic treatments, acne treatments, and other treatments disclosed herein. Figure 2A A view showing the tissue contact area of ​​the applicator is illustrated. The applicator may include multiple needles (generally shown as 5, but with rows of needles, specifically 5a, 5b, 5c, and 5d). The needles are arranged as an electrode array 7 according to a pattern with equally varying spacing between them. As shown, the needle array 7 is arranged relative to the treatment head 10 of the applicator 3. In one embodiment, each needle 5 of the array 7 is an electrode. In another embodiment, the overall array 7 is an electrode. Each needle includes a tissue contact surface.

[0065] In various embodiments, one or more RF energy delivery devices transform a region, volume, or portion of tissue. Compared to other devices, RF delivery devices use short pulses of RF energy along with higher power output. This design facilitates better pain management during treatment segments, such as less pain during treatment. In one embodiment, the treatment time during RF energy delivery ranges from about 3 milliseconds (ms) to about 5 ms. In one embodiment, the RF power delivered ranges from about 200 to about 400 watts. In one embodiment, the RF-powered delivery ranges from about 250 watts to about 350 watts. In one embodiment, the output voltage delivered to a given tissue region, portion, or volume ranges from about 150 volts RMS to about 550 volts RMS.

[0066] In one embodiment, the pins are equidistant from the vertices of a hexagon, with one pin positioned at the center of the hexagon to define an equidistant spacing of approximately 60 degrees relative to a given center pin. In one embodiment, the distance between the pins ranges from approximately 0.5 mm to approximately 3 mm. In one embodiment, the pin spacing is approximately 1.5 mm. The processing array can range from approximately 1 mm × approximately 1 mm to approximately 30 mm × 30 mm. For various embodiments, each of the electrodes (pins / tip) in a given electrode array is connected in parallel and monitored in parallel, such as during impedance, voltage, resistance, current, and other input, output, and processing segment-specific measurements. In some embodiments, hybrid or selectively addressable electrode arrays are used with one or more control circuits operable to activate a subset of electrodes in a larger array designed to cover a larger processing area.

[0067] As shown in the figure, the treatment applicator head 10 includes an internal portion with an array of holes through which electrode pins can extend and / or retract. In some embodiments, the electrodes are fixed in the extended position. Figure 2B A side view of a treatment applicator 3 with a tapered shaft is shown, having a first end including a treatment applicator head 10, and a second end or applicator end 25 in communication with an analysis and / or control system. One or more cables 30, such as nested cables within a common sheath, extend from the end and connect to the analysis and / or control system. The one or more cables may include cables for power and control signal transmission. Furthermore, the treatment head 10 may include one or more ports or surfaces in fluid communication with a coolant reservoir or other coolant system. Additionally, the treatment head may include a suction port in fluid communication with a conduit bundled with and / or one or more cables / conduits 30. The treatment head 10 may be attached to the body 3a of the applicator 3 via various fasteners / attachment assemblies 35.

[0068] like Figure 2C As shown, the treatment applicator head is detachably attached to the treatment applicator. When switch 38 is activated, the treatment applicator can be separated from the body 3a of the treatment applicator 3. In some embodiments, the switch is slidable. In other embodiments, the switch is pressable. Various compression fits and other tension-based attachment mechanisms can be used to releasably connect the treatment head 10 to the body 3a. In various embodiments, the treatment applicator is disposable after use. In some embodiments, the treatment applicator head 10 is removable for cleaning and / or disinfection.

[0069] Figure 3A This is based on an embodiment of the present disclosure. Figure 2A-2DThe image depicts a perspective view of the treatment applicator body 3a, applicable to skin rejuvenation and other treatments. As shown, the treatment applicator body does not have a removable treatment applicator. The treatment applicator body includes a second end or tip 25, which is connected to a communication cable 30 capable of being connected to an analysis and / or control system.

[0070] Figure 3B This is an exploded view of the applicator head 10a according to an embodiment of the present disclosure. The applicator head may be together with the applicator body 3a, such as... Figure 3A The illustrated treatment applicator head 10a is used in conjunction with an electrode array and other components to form an integral treatment applicator. The illustrated treatment applicator head 10a includes a fastening element 35, a fixing element 37 such as a nut (as shown), a housing 41, an inner housing 43, a first support or gasket 45, and a second support or gasket 47. A given support or gasket may be fitted within a given housing or otherwise disposed or arranged relative to a given housing. References to the first and second supports are non-limiting, and any support may begin as referred to as the first support, with subsequent supports being identified as the second support without limitation. Electrode arrays or assemblies, such as conductive plates having conductive pins or needles electrically connected thereto, are also incorporated into the treatment head, such that the pins or needles extend outward in a direction facing the tissue. The head 10a may also include one or more conduits and ports defined by one or more of their surfaces, suitable for aspirating air, smoke, fluids, etc., and / or delivering coolants, agents, or other liquids or gels to a reservoir within the head or to tissue.

[0071] Figure 4 According to embodiments of this disclosure, an n-electrode array 7a includes multiple needles 5 for a treatment applicator. As shown, the electrodes are coupled to individual pads arranged in rows. When mounted within the treatment applicator, each electrode within the array can be individually controllable. In one embodiment, the pins or needles (e.g., non-penetrating or blunt needles) and the plates extending from them are a single conductive structure. The electrode array comprises metal or one or more metals, such as alloys. In one embodiment, a control system is used to address and measure all electrodes in parallel.

[0072] Figures 5A-5C This is a simplified cross-sectional view of an electrode array from a treatment applicator that applies RF energy to the skin, according to an embodiment of the present disclosure. As depicted, the electrode rows in the array include needles or pins 5a, 5b, 5c, and 5d. In one embodiment, the pins or needles 5 are also referred to as dot matrix probe pins / needles. Pins / needles 5a-5d represent a subset of electrodes from the treatment applicator (e.g., ...). Figure 2A-2D or Figure 1C(As shown in the figure). The needles and the entire electrode array are positioned to contact the treatment area of ​​the tissue, in this case, the skin. In one embodiment, deformation of the skin at the needle contact point is achieved by the operator pressing the surface of the electrode array into the skin. In other embodiments, the pins / needles of the array remain on the skin surface and descend into the skin as the tissue is subsequently deflected or removed after RF energy is applied through one or more of the pins or needles.

[0073] Upon contact, the controller and / or analysis system pulses RF energy through each electrode. The pulsed RF energy induces tissue transformation, such as tissue removal at the contact point or other transformation or deformation processes as disclosed herein. In some embodiments, skin tissue transformation ( Figure 5B (As shown in the diagram) This causes tissue removal. In other embodiments, the electrodes are heated, causing the tissue in contact with each electrode to be carbonized and removed from the skin. In some embodiments, the tissue in contact with the electrodes evaporates due to the use of RF energy. In other embodiments, after RF energy is applied to the electrode array, one or more transformations occur with respect to the tissue, as disclosed herein, including combinations of different transformations.

[0074] In various implementations, the tissue undergoes a transformation, resulting in its removal and the movement of the pins / needles of the electrode array into a previously occupied tissue volume. This tissue has been transformed and effectively removed or altered from the subject through processes such as compaction, vaporization, carbonization, plasma formation, or other transformations initiated or caused by RF energy transfer. As the tissue is removed (e.g....), Figure 5C (As shown in the diagram), the electrode contacts the underlying healthy tissue. The given tissue may have one or more parameters that vary depending on the given subject, such as pigmentation, hydration, tissue thickness, etc. In some embodiments, the tissue may be fumed or vaporized, and it may be removed by a fluid transfer device, which may be part of or separate from the applicator.

[0075] In various implementations, as the treatment applicator is placed on the skin and RF signals / energy are delivered to the skin, a control system or impedance detection subsystem in communication with the treatment applicator measures the skin's impedance. As RF energy is applied to the skin through each electrode, the measured impedance increases due to tissue transformation occurring at the area where the electrode array contacts the tissue. Because the RF energy induces one or more tissue transformations, such as damage, the tissue impedance increases slowly as tissue is removed or otherwise transformed.

[0076] Once the electrode array penetrates further into the tissue and contacts the underlying tissue layer, a decrease in impedance is detected. In one embodiment, the decrease in impedance is associated with the electrode array contacting a more conductive tissue layer beneath the tissue that has recently undergone a transformation process. The initial increase in impedance is referred to as an impedance rise, and the subsequent unexpected decrease in impedance is referred to as an impedance (ramp) fall. Figure 2A-5C And various other aspects of the applicants and / or arrays disclosed herein may be related to those disclosed herein, such as... Figure 1B , 1C It can be used in conjunction with one or more other arrays such as 2A and / or one or more applicators.

[0077] Figure 6 This is a diagram illustrating the action of treating a portion of skin according to an embodiment of the present disclosure. As shown, the diagram displays the power (i.e., the power output of the system), the current transmitted by the treatment applicator, the detected resistance, and the measured voltage. As shown, the power corresponds to the power cycle of the DC buck converter transistor, which corresponds to the output DC voltage from the DC buck converter. In various embodiments, 0 power is 0 voltage, while 1.0 power is the maximum DC voltage. In various embodiments, the system controls the RF output voltage (the voltage applied to the subject) because, for a given load impedance, the buck DC voltage is proportional to the RF output voltage. In various embodiments, the power supply may have a range of voltage outputs, including various setpoints, such as... Figure 8 The high, medium, and low setpoints are shown in the figures. The maximum DC buck power mentioned herein refers to the maximum output voltage of the power supply. In one embodiment, the power supply is a buck-boost power supply. In various embodiments, the resistors shown in the figures and discussed elsewhere herein are related to or the same as the impedances.

[0078] Before RF energy is transmitted, the measured resistance is approximately 3017 ohms, with a corresponding current of approximately 67 mAms and a voltage of approximately 204 Vrms. The resistance curve plotted based on the measured or calculated resistance value initially rises and then (ramps down). After the processing energy is transmitted to the target tissue, the resistance (ramps down) to approximately 1417 ohms, with a corresponding current of approximately 277 mAms and a voltage of approximately 393 Vrms. In one embodiment, this change in resistance / impedance occurs approximately 600 microseconds after the resistance / impedance begins to rise. In various embodiments, tissue processing occurs for a period of time after the decrease in resistance / impedance following its initial increase / rise.

[0079] Figure 7-10 This is a graphical display illustrating different electrical signals and their variations during the application of RF pulse energy from the electrode array of the processing applicator according to an embodiment of the present disclosure. Figure 7 The graph shown illustrates the relationship between power output, current, impedance, and voltage over time. After processing begins, the output power ramps up over approximately 500 microseconds. Alternatively, in another embodiment, the output power ramps up over approximately 100 microseconds to approximately 5 ms, or approximately 500 microseconds to approximately 1 ms, at the start of processing. As shown, line T2 represents the time to reach maximum impedance. In various embodiments, T2 also corresponds to the occurrence of maximum resistance. T2 also indicates the beginning of a substantially flat output power after the ramp-up preceding T2. T1 represents the time after the impedance drops and reaches a flat, stable state. The entire pulse occurs within milliseconds, with the difference between T1 and T2 being approximately 1.3 ms.

[0080] In one implementation, the RF power transfer time ranges from approximately 0.3 ms to approximately 50 ms. In one implementation, the impedance drop value is also referred to herein as impedance or resistance threshold or threshold drop. Figure 9 In this context, it is designated as r_drop_threshold. Threshold drop corresponds to the threshold used to determine when an impedance drop has been achieved. Once a resistance / impedance drop that meets or exceeds the expected threshold drop occurs, the control system starts a timer to continue processing with RF energy. In various implementations, different impedance / resistance thresholds can be specified for different tissues / body parts. In some implementations, the time period from T2 to the output voltage ramp-down corresponds to the processing time.

[0081] At time T1, the electrodes from the treatment applicator have penetrated the outer layer of the tissue and made contact with the underlying tissue. In one embodiment, the conductivity of the underlying tissue is greater than that of the treated tissue. In various embodiments, the treatment time is a substantially flat region of the output power graph between a slowly rising ramp and a downwardly sloping ramp, i.e., a plateau region between ramps. In one embodiment, the ramp time is controlled to reduce or prevent muscle tissue twitching or otherwise experiencing involuntary contractions / spasms. In one embodiment, the ramp time ranges from greater than about 0 to about 500 ms. In another embodiment, the output voltage ramp time is about or about 500 microseconds. Alternatively, in another embodiment, the output voltage ramp time ranges from about 100 microseconds to about 5 ms, or from about 500 microseconds to about 1 ms. In one embodiment, the pulse duration and output power can be selected by the user and can be adjusted based on one or more parameters associated with a given treatment subject / tissue type.

[0082] In various embodiments, when operating the processing system, the user can select the operating setpoint and pulse duration. In various embodiments, the setpoint indicates the amount of RF energy transmitted through the processing applicator. The setpoint variable can be set to high, medium, or low. These can be automatically set using measured impedance or specified by the user based on the operator's experience with various tissue types / skin parameters. In various embodiments, the pulse duration corresponds to the amount of time the RF energy pulse is effective. In at least one embodiment, the pulse duration can be set between about 1 ms and about 12 ms.

[0083] In various embodiments, the pulse duration can be modified based on a prescribed process. In some embodiments, a foot switch is used to control the initiation of pulses within the system. In these embodiments, the RF pulse is initiated when the foot switch is pressed and terminates regardless of whether the user releases the switch. In one embodiment, the maximum operating frequency is approximately 1.5 Hz. In another embodiment, the maximum operating frequency is approximately 3 Hz. In yet another embodiment, the maximum operating frequency is approximately 5 Hz. The operating frequency range can be approximately 0.5 Hz to approximately 10 Hz, approximately 0.5 Hz to approximately 5 Hz, or approximately 1.5 Hz to approximately 5 Hz. In various embodiments, the system operation produces an audible sound lasting approximately 500 ms. In various embodiments, the processing applicator is implemented with a maximum power output of approximately 200 watts. Each setpoint corresponds to an amount of RF output provided by the system. Some examples of various system values ​​are listed in the table below, and the relevant scaling factors are discussed in the table below.

[0084] High set point 1.2 N / A Middle_Set Point 1.0 N / A Low set point 0.8 N / A r_decline_threshold 0.2 N / A r_resistance_decrease_sp 0.003 s Slope_Time 0.0005 s

[0085] Each of the aforementioned values ​​is an “approximate” value shown and can vary within a range such that each value in the table spans a range defined by multiplying or dividing the given value by a factor selected from a group of approximately 1 to approximately 50.

[0086] For example, in one implementation, "high" corresponds to ramping the DC buck power to a high setpoint * DCBUCKDUTYMAX. "Medium" corresponds to ramping the DC buck power to a medium setpoint * DCBUCKDUTYMAX. "Low" corresponds to ramping the DC buck power to a low setpoint * DCBUCKDUTYMAX. In various implementations, DCBUCKDUTYMAX refers to the maximum amount of RF energy that can be provided by a controller and / or analysis system connected to the processing applicator.

[0087] like Figure 8 As shown, the setpoint is set to "high" and has 500. μsThe ramp ascent and ramp descent times. In this example, the ramp ascent and ramp descent times are set to minimize the likelihood of muscle response when RF energy is applied to the skin.

[0088] like Figure 9 As shown, the controller and analysis system are configured with a drop threshold of 0.2, which corresponds to a 20% impedance drop. In this case, the processing is successful, shown as a 20% resistance drop between T2 and T1. The drop threshold is shown by a dashed line and illustrates the initial rise in impedance, followed by a drop in impedance after T2. In one implementation, the processing period begins at T2 and lasts for a millisecond time period as disclosed herein. In various implementations, the impedance / resistance drop threshold ranges from about 5% to about 80%, or from about 10% to about 90%, or from about 20% to about 50%.

[0089] like Figure 10 As shown, the processing time is defined by the drop threshold and the pulse duration. Processing begins when the amount of impedance drop equals the drop threshold, denoted as r_drop_threshold, and represented by the dashed line shown. In various implementations, the pulse duration is set by the user.

[0090] Figure 11A This is a photograph of the skin after treatment according to an embodiment of the present disclosure. As shown, the treatment applicator has created a dotted treatment pattern within the skin, and the outer portion of the tissue has been removed. The area in contact with the electrodes is indicated by dashed circles. The treatment duration used is selected in response to impedance monitoring and is customized for the individual receiving the treatment. In this way, by performing impedance monitoring, factors such as the hydration level, age, pigmentation, tissue condition, and other factors of a given subject can be used as factors in setting the treatment duration. See also... Figure 1B The described tissue damage includes Figure 1B The hole / pit W shown is Figure 11A The image shows a depiction of the cross-section of one of the circular damage patterns in the lattice processing mode.

[0091] The fractional lesion pattern shown offers several advantages for skin rejuvenation. With this pattern, the damaged portion of the epidermis is presented as an island of damage surrounded by healthy / untreated tissue. This surrounding healthy / untreated tissue allows the treated tissue to heal / recover more quickly. This faster healing from a smaller distribution of fractional lesions contrasts with methods that treat all tissue in a single area with larger, aggregated lesions, resulting in a slower overall recovery time. Compared to larger, aggregated treatments, the fractional approach promotes faster tissue repair and regeneration.

[0092] Figure 11BThese are photographs of skin treated according to embodiments of this disclosure. Compared to Figure 11A , Figure 11B This indicates that the treatment was unsuccessful. In this case, the treatment duration was not long enough to remove the outer layer of tissue. The area where treatment was attempted is shown with a dashed circle. Therefore, the treatment did not remove enough tissue to reach the healthy tissue underneath.

[0093] Figure 1A This image shows partial superficial skin damage observed after RF fractional processing using the example device described above. Histological and clinical studies were conducted to evaluate the observed superficial skin damage at a microscopic level.

[0094] A patient scheduled for abdominoplasty was recruited for a histological clinical study. Prior to abdominoplasty, the area to be excised was marked and divided into four treatment zones (1, 2, 3, and 4). In zones 1 and 2, impedance-guided timing treatment with and without skin moisturization was evaluated pre-treatment. In zones 3 and 4, treatment with and without skin moisturization was evaluated against impedance-guided timing or normal timing. A skin moisturizer was applied to zones 1 and 3 half an hour before treatment. In all four zones, the treatment power level varied between levels 1, 2, and 3, and the power delivery duration ranged from approximately 1 ms to approximately 8 ms. The applied moisturizer was provided to zones 1 and 3 to improve the consistency of electrical characteristics when the RF dot matrix was applied to the treatment zone.

[0095] All procedures were performed while the patient was under anesthesia. After resection of the abdominoplasty surgical area, approximately 6 mm of perforated biopsy tissue was obtained from each treated area. The biopsy tissue was stained with hematoxylin / eosin (H&E) and evaluated under an optical microscope. Example micrographs are shown below. Figure 12A and 12B In the middle. Both images show histology taken from region 1 before level 3 treatment with a moisturizing agent applied and using impedance-guided timing. Processing time was approximately 3 ms. Figure 12A The organization within it processes the data in approximately 5ms. Figure 12B The organization within.

[0096] Histological observations by a licensed dermatologist revealed: "Intact fractional epidermis and superficial papillary dermis ablation, with wounds limited to adjacent papillary dermis within 60 to 80 micrometers. This dermatologist's practice includes reading dermatological histology. Ablation depth increased with prolonged work time. Histological results were more consistent with those obtained with topical application of a moisturizer compared to samples without such application."

[0097] The observed ablation areas and the wounds in the papillary dermis act as conduits for the externally applied compounds or mixtures of compounds. Macromolecules and non-lipid-soluble topical products or other topical products that do not absorb well through the intact epidermis can be selected to achieve greater absorption in the fractional skin feature created using the systems, apparatus, and methods disclosed herein. Examples of topical materials and molecules / compounds expected to have greater absorption in a fractional skin feature include: growth factors; antioxidants, such as vitamin C or other molecules with similar properties; PRP (platelet-rich plasma); tranexamic acid; and azelaic acid. A variety of aqueous and non-aqueous lotions and topical products can be used in various embodiments. Conditions addressed by such topical products with enhanced penetration can include acne, melasma, acne scars, freckles, wrinkles, uneven pigmentation, redness, and rosacea.

[0098] The histological lesions involving the epidermis and dermis created using the systems, apparatus, and methods disclosed herein are generally similar to those created by low-power lattice CO2 and lattice Er:YAG treatments. Therefore, drug penetration data collected using lattice CO2 and lattice Er:YAG devices will be applicable to RF lattice lesions created by such devices. Drug penetration for drugs has been studied using lattice CO2 and lattice Er:YAG, and similar drugs can be used for RF lattice lesion-assisted delivery. Examples of drugs and substances with enhanced skin penetration reported via lattice CO2 and lattice Er:YAG devices are provided. Merete, et al. "Fractional CO2 laser-assisted drug delivery." *Lasers in Surgery and Medicine: 42.2 (2010): 113-122 and Lin, Chih-Hung, et al. "Lasers as an approach for promoting drug delivery via skin." *Expert Opinion on Drug Delivery 11.4 (2014): 599-614," the contents of which are incorporated herein by reference in their entirety.

[0099] Examples of drugs and substances reported in these references and suitable for use as external treatments during RF treatment include: nalbuphine and indomethacin; morphine, nalbuphine, and buprenorphine; 5-aminolevulinic acid; methotrexate; lidocaine; dextran; oligonucleotides and plasmid DNA; peptides and vaccines; small interfering RNA and plasmid vectors; TiO2 nanoparticles (100 nm) and Al2O3 microparticles (27 μm); Vitamin C and magnesium ascorbate phosphate; 3-O-ethyl ascorbic acid and ascorbate 2-glucosidase; Diclofenac; Prednisone; ALA; Imiquimod, peptides and dextran; Ovalbumin; ATG and basiliximab; CpG adjuvant allergens; Methyl ALA; Ascorbate 2-glucosidase; Polyethylene glycol (400, 1000, 2050 and 3350 Da); siRNA and plasmid DNA; Dextran and quantum dots. Examples of drugs and substances that have enhanced skin penetration after physical enhancement of the epidermis are provided in Benson, Heather AE, "Transdermal drug delivery: penetration enhancement techniques." Current drug delivery 2.1 (2005):23-33 and Cross et al., "Physical enhancement of transdermal drug application: is delivery technology keeping up with pharmaceutical development?" Current drug delivery 1.1 (2004):81-92, the contents of which are incorporated herein by reference in their entirety.

[0100] One or more topical agents can be applied prior to RF dot matrix treatment to improve the consistency of electrical properties when RF dot matrix energy is applied to the treatment area. Topical agents can also be applied to penetrate RF dot matrix damage created by the RF dot matrix device. In various embodiments, a single topical agent, such as a moisturizer, can be used to improve one or more electrical or other properties during RF energy delivery. Topical agents can be selected based on enhanced tissue penetration properties, such as better penetration relative to tissue damage created by the RF-based systems and methods disclosed herein. A given topical agent can be applied before treatment, reapplied during treatment, applied after treatment, or a combination of the foregoing.

[0101] Alternatively, a multi-step process can be employed, comprising a first treatment course of topical application prior to treatment with the RF fractional device and a second treatment course of topical application to the RF fractional lesions already created in the tissue. The topical products used in this multi-step process can be the same or different products.

[0102] Finally, in some embodiments, the RF dot matrix device is used to treat skin to which no topical product has been applied, and after RF dot matrix damage has been created in the tissue, the topical product can be applied to the RF dot matrix damage.

[0103] Conditions that can be addressed by using RF dot matrix devices and topical products include acne, melasma, acne scars, blemishes, wrinkles, uneven pigmentation, redness, and erythematous acne.

[0104] Figure 13 This is a block diagram illustrating the interaction between the control system and impedance assessment feedback surrounding impedance diagnosis during RF power delivery and subject handling. In the system, AC power is converted to DC voltage in an AC-to-DC converter. The DC voltage is delivered to the RF power amplifier and then through the patient separation component (e.g., a transformer). Starting from patient separation, RF power is subsequently delivered to the handpiece / electrode and the electrode array attached to the handpiece (e.g., 1C and 2B-2D) (see, e.g., Figure 1C , 2A , 4 and 5A-5C), and then RF power is transmitted to the patient via the array of needle or non-penetrating needle electrodes (e.g. pins).

[0105] RF power can be transmitted in unipolar or bipolar mode, or a single system can transmit both unipolar and bipolar modes (e.g., the Potenza manufactured by Jeisys Medical, Inc.). TM RF microneedle systems combine monopolar and bipolar RF at 1 or 2 MHz in a single device. The electrodes in the electrode array are also called needles or blunt needles. RF power is delivered to the patient at a level suitable for treating the target condition, such as skin rejuvenation, or for creating fractional lesions to enhance the penetration of topical products into the skin. Conditions addressed by topical products with enhanced penetration can include acne, melasma, acne scars, freckles, wrinkles, uneven pigmentation, redness, and rosacea. The RF power used for treatment ranges from about 1 milliwatt to about 10 kilowatts, or from about 100 milliwatts to about 500 watts.

[0106] Optionally, Figure 13Not shown, the DC voltage passes through a DC-DC buck converter, which controllably converts the supplied DC voltage to the desired RF frequency. The controlled DC voltage is then transmitted to an RF power amplifier and then through a patient disconnect (e.g., a transformer). From the patient disconnection point, the RF power is then transmitted to the patient via the handheld device / electrode array disclosed herein.

[0107] Therapeutic treatment:

[0108] Still referencing Figure 13 The system energizes a single electrode or a selected subset of single electrodes (unipolar mode) or a subset of electrode pairs (bipolar mode) on the handheld device to therapeutically treat areas identified as benefiting from the desired treatment. To complete the therapeutic treatment, RF power is transmitted to the patient via electrodes present on the handheld device. The control system provides control signals instructing the RF power to be multiplexed to the patient's tissue through an array of electrodes present on the handheld device.

[0109] In various implementations, the control system multiplexes either a single electrode (unipolar mode) or several pairs of electrodes on the handheld device (bipolar mode). For example, RF power is delivered to the patient at a level suitable for treating a target condition such as skin rejuvenation or for creating fractional lesions to enhance the penetration of the topical product into the skin. Conditions addressed by topical products with enhanced penetration can include acne, melasma, acne scars, freckles, wrinkles, uneven pigmentation, redness, and rosacea. The RF power used for treatment ranges from about 1 milliwatt to about 10 kilowatts, or from about 100 milliwatts to about 500 watts.

[0110] In general, 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 can be used to rejuvenate the skin or to create fractional lesions to enhance the penetration of topical products into the skin. 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 of the undesirable conditions disclosed herein.

[0111] Additional details relating to the various systems that use RF and impedance sensing to process tissue 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.

[0112] Additional details relating to various systems for processing tissue using RF and impedance sensing are disclosed in U.S. Publication No. 20190239939, entitled “METHODS AND APPARATUS FOR CONTROLLED RFTREATMENTS AND RF GENERATOR SYSTEM,” the entire disclosure of which is incorporated herein by reference. Furthermore, additional details relating to various systems for processing tissue using RF and impedance sensing are disclosed in U.S. Application No. 17 / 308,898, filed May 5, 2021, entitled “Needle-Array Devices and Related Methods,” the entire disclosure of which is incorporated herein by reference.

[0113] This document describes systems and methods for treating an individual's skin (e.g., dermis and hypothalamus) or other target tissues located at a depth below the tissue surface using RF energy. In various aspects, this teaching can provide non-invasive, cooled (or non-cooled) RF-based treatments to achieve, as non-limiting examples, one or more of the following: body shaping (lipolysis), sebaceous gland treatment, gland damage / deactivation, skin tightening (relaxation improvement), cellulite treatment devices, vaginal relaxation treatment or restoration, urinary incontinence treatment, fecal incontinence treatment, and treatment of other urogenital conditions.

[0114] It should be understood that, for clarity, the following discussion will illustrate various aspects of the implementation of the applicant's teachings, while omitting certain specific details wherever 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 some implementations of the applicant's teachings may not require the specific details described in each implementation, which are set forth herein merely for the purpose of facilitating a thorough understanding of the implementation. Similarly, it will be apparent that the described implementations can be readily modified 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.

[0115] As used herein, the terms “about” and “substantially” refer to possible variations in numerical quantities, such as those occurring through real-world measurement or processing procedures; those occurring through unintentional errors in such procedures; those occurring through variations / failures in the manufacture of electrical components; those occurring through power losses; and variations that a person skilled in the art would consider equivalent, provided that such variations do not encompass values ​​known from prior art practice. Generally, the term “about” means a value greater than or less than 1 / 10 of a specified value, or a range of values, for example, ±10%. For example, applying a voltage of about +3V DC to an element could mean a voltage between +2.7V DC and +3.3V DC. Similarly, where values ​​are referred to as “substantially the same,” these values ​​can differ by up to 5%. Regardless of whether modified by the terms “about” or “substantially”, the numerical values ​​set forth in the claims include equivalent forms of the stated values, such as possible variations in the numerical quantities of such values ​​that a person skilled in the art would consider equivalent.

[0116] Furthermore, nothing disclosed herein is intended for the general public, whether or not such disclosure is expressly stated in the claims. Unless the phrases “intended for” or “for the purpose of…” are expressly used in a particular claim, the applicant wishes to note that they do not intend any claimed feature to be construed as being based on or otherwise invoked under 35 USC 112(f) in order to assist the Patent Office and any reader of any patent issued under this application in understanding the appended claims or other claims presented in ongoing or subsequent patent applications.

[0117] All accompanying figures include one or more decorative features and views, each of which includes solid lines, any of which also combine with and correspond to dashed lines and provide support for dashed lines, and alternatively, each of which includes dashed lines, any of which also combine with solid lines and provide support for solid lines.

[0118] Unless otherwise specified, the use of the terms “include,” “includes,” “including,” “have,” “has,” or “having” should generally be understood as open-ended and non-restrictive.

[0119] Unless otherwise specified, the use of the singular in this document includes the plural (and vice versa). Furthermore, unless the context clearly indicates otherwise, the singular forms “a / an” and “the” include the plural form. Additionally, unless otherwise specified, the teachings of this application also include the specific quantitative value itself when the term “about” is used before a quantitative value.

[0120] It should be understood that the order of steps or the sequence of actions is not important as long as the teachings of this application remain operable. Furthermore, two or more steps or actions can be performed simultaneously.

[0121] When a range or list of values ​​is provided, each intermediate value between the upper and lower limits of that range or list of values ​​is considered individually and encompassed in this disclosure, just as each value is specifically listed herein. Furthermore, smaller ranges between the upper and lower limits of a given range, and including the upper and lower limits of a given range, are contemplated and encompassed in this disclosure. The list of exemplary values ​​or ranges is not a negative representation of other values ​​or ranges between the upper and lower limits of a given range, or including the upper and lower limits of that range.

[0122] 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 as covered by the appended claims.

Claims

1. An apparatus for cosmetic tissue treatment, comprising: Control system; A treatment applicator containing an electrode array of multiple needles, wherein each needle is an electrode electrically connected to the control system, and the electrode array contacts the portion of the tissue when the treatment applicator is placed on a portion of the tissue. The control system is operable This allows radio frequency (RF) energy pulses to be applied to portions of the tissue via the electrode array; The impedance of the measuring electrode array changes over time; The measured impedance decreases upon initial increase in impedance when the detection electrode array comes into partial contact with the tissue; and A processing period begins when an initial increase in impedance followed by a decrease to a threshold is detected, and the application of the RF energy pulse is terminated after the processing period.

2. The apparatus of claim 1, wherein the duration of the pulse is between about 1 ms and about 12 ms.

3. The apparatus of claim 1, wherein impedance is measured at a sampling rate ranging from about 10 kHz to about 50 kHz.

4. The apparatus of claim 3, wherein impedance is measured at a sampling rate of about 30 kHz.

5. The apparatus according to claim 1, further comprising: Avoid triggering muscle spasms during the treatment period.

6. The apparatus of claim 5, wherein the electrode array has an output voltage with a ramp time range of about 100 milliseconds to about 5 ms.

7. The apparatus of claim 1, wherein a plurality of electrodes are connected in parallel.

8. The apparatus according to claim 1, further comprising: The transformation of the tissue results in the removal of the tissue near the point of contact with a subset of the plurality of electrodes.

9. The apparatus of claim 1, wherein the topical application is applied to a portion of the tissue prior to the application of the treatment applicator.

10. The apparatus of claim 9, wherein the topical product is applied to a portion of the tissue after a treatment period.

11. The apparatus of claim 1, wherein the topical agent is applied to a portion of the tissue after a treatment period.

12. The device according to claim 11, wherein the external product is a skin moisturizer.

13. The apparatus of claim 1, wherein the RF energy pulse travels along the electrode surface and induces a tissue effect upon reaching a portion of the tissue.

14. The apparatus of claim 1, wherein one or more annular lesions are generated in tissue in response to a radio frequency (RF) energy pulse.

15. An apparatus for processing tissue, comprising: A first processing applicator head, the first processing applicator head including a first plurality of needles; and An applicator body having a first end connected to the first processing applicator head; The applicator body includes a second end that is connected to an RF power supply and a control system; Wherein, the first processing applicator head is electrically connected to the RF power supply when connected to the applicator body, and the RF power supply is connected to the second end; The control system is operable to terminate tissue processing after a processing period occurs, the processing period being initiated upon detection of an initial increase in impedance followed by a decrease in impedance.

16. The apparatus of claim 15, wherein each of the plurality of needles has a blunt tip.

17. The apparatus of claim 15, further comprising a second treatment applicator head, the second treatment applicator head including a second plurality of needles, wherein the first end of the applicator body is connected to the second treatment applicator head, wherein, The second processing applicator head is electrically connected to the RF power supply when connected to the applicator body.

18. An apparatus for cosmetic treatment, comprising: A first processing applicator head, the first processing applicator head including a first plurality of needles; and An applicator body having a first end connected to the first processing applicator head and a second end connected to an RF power supply and control system; Wherein, the first processing applicator head is electrically connected to the RF power supply when connected to the applicator body, and the RF power supply is connected to the second end; The control system is operable to terminate tissue processing after a processing period occurs, the processing period being initiated upon detection of an initial increase in impedance followed by a decrease in impedance.

19. The apparatus of claim 18, wherein the decrease in measured impedance is related to an untreated area of ​​tissue contacted by one or more of the first plurality of needles.

20. The apparatus of claim 19, wherein the first conductive properties of the untreated region of the tissue are different from the second conductive properties of the treated region of the tissue.

21. The apparatus of claim 20, wherein the treated region of the tissue is disposed above the untreated region of the tissue.

22. The apparatus of claim 18, wherein the RF power is reduced when a decrease in the impedance of the tissue is detected.

23. The apparatus of claim 22, wherein the processing time for applying the RF power ranges from about 1 ms to about 12 ms.

24. The apparatus of claim 18, wherein the decrease in measured impedance ranges from about 10% to about 90%.

25. The apparatus of claim 18, wherein the decrease in measured impedance ranges from about 20% to about 50%.

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