Apparatus and method for staging tissue using tissue properties

Abstract

Disclosed herein is a skin tissue treatment device and method comprising at least one first elongate electrode having a first polarity and configured for receiving an electrical current from an electrical current source and for insertion into skin tissue to one or more depths. Also included is at least one second electrode located proximate to the at least one first elongated electrode and configured to receive current from the current source in a second polarity opposite the at least one first elongated electrode; and an actuation mechanism connected at least to the at least one first elongate electrode and configured to spatially move the first elongate electrode along the one or more axes. At least one controller connected to the at least one first elongate electrode, the at least one second electrode, the current source and the actuation mechanism; and the at least one controller is configured to: control the current source; actuating the actuating mechanism; and selectively applying a staged treatment of at least one of skin tissue ablation, skin tissue coagulation, or skin tissue mechanical insertion to the skin tissue.

Description

[0001] Cross-reference to related applications

[0002] This application claims the priority of U.S. Provisional Patent Application No. 63 / 530,561, filed August 3, 2024, entitled “DEVICES AND METHODS FOR FRACTIONALTREATMENT OF TISSUE UTILIZING TISSUE PROPERTIES”, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The published text belongs to the field of medical aesthetics and specifically relates to devices and methods for treating tissues (such as skin) for aesthetic and / or cosmetic purposes. More specifically, the published text relates to devices and methods for grading the skin tissue of a subject. Background Technology

[0004] Various skin tissue treatment techniques exist to revitalize skin tissue. Some treatments involve graded skin tissue treatment, a term used to describe a form of treatment that creates a discrete array of relatively small treatment sites within the skin tissue, leaving areas of healthy, untreated skin tissue surrounding the treatment sites. Treatment sites can be created using optical (e.g., laser), electromagnetic (e.g., radio frequency), acoustic (e.g., ultrasound), or other energy / modal methods. At each treatment site, micro-damage is created within the skin tissue. This micro-damage at the treatment site triggers the skin tissue's natural healing response. The intact, healthy skin tissue surrounding the treatment site provides the foundation for healing the micro-damage.

[0005] Examples of graded skin tissue treatment can be found in WO2021234609A1 and WO2021234605A1, which have been assigned to the assignee of the public text, and are incorporated in full hereby by reference. Summary of the Invention

[0006] The subject matter disclosed herein provides devices and methods for skin tissue treatment. The disclosed text provides a skin device comprising: a current source configured to provide alternating current (AC), direct current (DC), or any combination thereof; at least one first elongated electrode having a first polarity and configured to receive current from the current source and for insertion into skin tissue to one or more depths; at least one second electrode located near the at least one first elongated electrode and configured to receive current from the current source with a second polarity opposite to that of the at least one first elongated electrode; an actuation mechanism at least connected to the at least one first elongated electrode and configured to spatially move the first elongated electrode along one or more axes; and at least one controller connected to the at least one first elongated electrode, the at least one second electrode, the current source, and the actuation mechanism. The at least one controller is configured to: control the current source; actuate the actuation mechanism; and selectively apply treatments of skin tissue ablation, skin tissue coagulation, or mechanical insertion of skin tissue to the skin tissue.

[0007] In one aspect of the disclosed subject matter, the device also includes a handheld component configured to be held by a user. The handheld component includes: at least one first elongated electrode; at least one second electrode; and an actuation mechanism. The device further includes a disposable end removably attachable to the handheld component, wherein the disposable end includes at least one of: at least the first elongated electrode; or at least one second electrode. Furthermore, the device includes a sensing system configured to transmit sensed data from skin tissue to a controller, wherein the sensed data indicates at least one of electrical impedance or mechanical impedance.

[0008] In another aspect of the disclosed subject matter, the device has at least one second electrode configured as at least one of the following: elongated in shape, configured to penetrate skin tissue; flat in shape, configured to contact the surface of skin tissue; or flat in shape with perforations, configured to allow at least one first elongated electrode to pass through and reach the skin tissue. In one aspect of the device, a plurality of at least one elongated electrodes are configured as a comb-like one-dimensional array, and the plurality of comb-like one-dimensional arrays are arranged side-by-side with each other along a second axis to form a two-dimensional array of at least one elongated electrode. In another aspect of the device, at least one elongated electrode is configured to have at least one of a plurality of insulating patterns on its surface, and further includes a plurality of conductive points along the plurality of insulating patterns, and the plurality of insulating patterns are configured in an elongated shape on at least one second electrode. In yet another aspect of the device, an actuator is additionally configured to rotate at least one elongated electrode about a longitudinal axis of at least one elongated electrode.

[0009] In one aspect of the disclosed subject matter, there is a method for processing skin tissue, comprising: providing a current source configured to provide alternating current (AC), direct current (DC), or any combination thereof; providing at least one first elongated electrode having a first polarity and configured to receive current from the current source and for insertion into skin tissue to one or more depths; providing at least one second electrode located near the at least one first elongated electrode and configured to receive current from the current source with a second polarity opposite to that of the at least one first elongated electrode; providing an actuation mechanism at least connected to the at least one first elongated electrode and configured to spatially move the first elongated electrode along one or more axes; providing a connection to the at least one first elongated electrode, the at least one second electrode, the current source, and the actuation mechanism; providing at least one controller; and positioning the at least one elongated electrode and the at least one second electrode in contact with the skin tissue. The method further includes selective activation by the at least one controller of: the current source for applying a current profile to at least one of the at least one first elongated electrode or the at least one second electrode; and the actuation mechanism for moving the at least one elongated electrode into or out of the skin tissue by a predetermined distance. Methods in which selective treatments such as skin tissue ablation, skin tissue coagulation, or mechanical insertion of skin tissue are applied to skin tissue.

[0010] In another aspect, the method further includes: activating a current source by at least one controller to provide a current profile to at least one first elongated electrode and at least one second electrode for a predetermined first time period; deactivating the current source by at least one controller; activating an actuation mechanism by at least one controller to move at least one elongated electrode into or out of skin tissue by a predetermined distance; and activating an actuation mechanism by at least one controller to move at least one elongated electrode a second distance.

[0011] In one aspect, the method further includes: providing a sensing system configured to transmit sensing data of at least one of the indicative impedance or mechanical impedance of skin tissue; and adjusting, based on the sensing data and by at least one controller, at least one of the following: a current received by at least one first elongated electrode, or a current received by at least one second electrode, or activating an actuation mechanism.

[0012] In another aspect, the method further includes selectively applying skin tissue ablation or skin tissue coagulation based on sensing data and adjusted by at least one controller. The method also includes providing a plurality of at least one elongated electrodes and dividing the plurality of at least one elongated electrodes into two or more groups of elongated electrodes; and the method further includes actuating two or more groups by at least one controller to move into and out of skin tissue in different activation modes. In some aspects, the plurality of at least one elongated electrodes may include at least one of the following: equal length; different lengths; equal cross-sectional area or shape; or different cross-sectional area / shape. Furthermore, in one aspect of the method, an actuation mechanism is configured to additionally rotate at least one elongated electrode about a longitudinal axis of at least one elongated electrode; and the method further includes actuating the actuation mechanism by at least one controller to move at least one elongated electrode into or out of skin tissue a predetermined distance as the at least one elongated electrode rotates about a longitudinal axis of at least one elongated electrode.

[0013] A final aspect of the method is provided, wherein at least one second electrode is configured to have a flat shape having a perforation configured to allow at least one first elongated electrode to pass through therethrough; and the method further includes actuating an actuation mechanism by at least one controller to move at least one elongated electrode a predetermined distance through the perforation into skin tissue. Attached Figure Description

[0014] To better understand the subject matter disclosed herein and to illustrate how it can be implemented in practice, implementation methods will now be described by way of non-limiting example only with reference to the accompanying drawings.

[0015] Figure 1 A non-limiting exemplary embodiment of a device based on the subject matter disclosed herein is shown.

[0016] Figure 2 Non-limiting exemplary embodiments of the methods disclosed herein are shown.

[0017] Figure 3 Non-limiting examples of graded skin tissue treatment using the devices and methods disclosed herein are shown.

[0018] Figures 4A to 4I Various shapes of elongated electrodes and second electrodes for use in a device are shown, according to non-limiting embodiments of the subject matter disclosed herein.

[0019] Figure 5 This is a close-up view of flat and elongated electrodes for use in a device according to a non-limiting embodiment of the subject matter disclosed herein.

[0020] Figure 6This is a perspective view of the distal portion of an elongated electrode in a device according to a non-limiting embodiment of the subject matter disclosed herein. Detailed Implementation

[0021] According to the published text, the treatment of tissue may involve one or more of the following: tissue ablation, where the tissue is ablated and no longer exists, for example, due to exposure to high heat energy; tissue coagulation, where the tissue is damaged to a certain extent to promote regeneration and revitalization, for example, when exposed to heat energy lower than that that caused ablation; and mechanical damage to the tissue. Mechanical damage is typically achieved by mechanical insertion or mechanical removal of elongated electrodes, referred to below as mechanical insertion.

[0022] Typically, ablation alone can be performed using a thin electrode to puncture the skin and move the electrode deeper into the skin tissue. As a skin tissue puncture and movement mechanism, ablation usually requires a short needle for optimal ablation. Alternatively, mechanical insertion utilizing pressure from a sharp or pointed thin electrode can often be used alone to puncture the skin and move it deeper into the skin tissue. In some embodiments of the disclosed text, puncture and movement into the skin tissue are accomplished by ablation and / or mechanical insertion pressure, and are employed in any combination of simultaneous, alternating, or any desired activation mode thereof.

[0023] Properties of skin tissue that can be used for optimized treatment include, for example, electrical impedance (resistance) and mechanical impedance. For instance, the properties of skin tissue and underlying tissue layers (such as fat and muscle) can vary relative to their electrical and / or mechanical impedance. Therefore, hierarchical treatment can be optimized in the spatial domain (and possibly in the temporal domain) to achieve effective treatment results.

[0024] Grading processes create a discrete array of relatively small treatment sites in skin tissue and leave areas of healthy, untreated skin tissue around the treatment sites. Typically, grading processes employ multiple spaced-apart elongated electrodes inserted into the skin tissue, such that only small areas of the skin surface are treated. Grading processes as referred to herein can be one-dimensional, two-dimensional, or three-dimensional. In some embodiments, grading processes are performed along a single axis, such as the propagation axis of the elongated electrode, needle, or pin. In some embodiments, multiple elongated electrodes are provided, arranged side-by-side relative to the skin tissue being treated, to perform grading processes along at least two axes with defined alignment (e.g., the propagation axis perpendicular to the needle or pin). In the disclosed text, “electrode” (singular) or “electrode” (plural) should be understood to mean one or more electrodes.

[0025] exist Figure 1The block diagram illustrates a non-limiting example of a device configured for grading skin tissue according to the subject matter disclosed herein. In some embodiments, device 100 is configured for grading skin tissue, the grading being tailored to the specific, localized properties of the skin or the tissue being treated. Specifically, alternating current (AC) (e.g., but not limited to, in the radio frequency (RF) range) and / or direct current (DC) may be employed. Thus, the AC and / or DC current source 160 may be part of the device as shown in 100A, or it may be located externally and connected to device 100.

[0026] In some embodiments, the current source is configured to controllably provide AC and DC simultaneously, alternately, or in any desired activation mode. That is, the current source 160 can provide electrical energy or current to generate heat and cause damage to the treated skin tissue. In some embodiments, the device is at least partially configured as a handheld device. For example, the components of the device may be housed within a handheld component that contacts the site of skin tissue to be treated.

[0027] In some embodiments, device 100 further includes one or more electrodes or microelectrodes 110, 120A, and 120B configured to receive and deliver current. In some embodiments, current is used alone or as a supplement to mechanical grading of tissue, as further described below. It should be noted that ablation of skin tissue can be accomplished using an AC signal that generates heat, while DC current can ablate tissue based on a chemical reaction. The electrodes in device 100 can be configured to have elongated shapes 110 and 120B. In some embodiments, the elongated shape allows the electrodes to be inserted deep into the tissue and optionally into the fat and / or muscle layers beneath the skin tissue. For this purpose, the elongated electrodes can have a length dimension much larger than their width and depth dimensions and can be referred to as microneedles or pins, having a solid or hollow cross-section.

[0028] In some embodiments, one or more first elongated electrode 110s are configured to receive a current of a first polarity and for insertion into skin tissue to one or more depths. In some embodiments, a second electrode 120A or 120B is configured to receive a current of the opposite polarity to the first polarity. In some embodiments, the second electrode 120A is a flat electrode. Flat second electrodes in combination with elongated electrodes are described in U.S. Patents 11,717,679 and 11,963,710, both filed May 19, 2021, which have been assigned to the assignee of the publication and are incorporated herein by reference in their entirety.

[0029] In some embodiments, the second electrode 120B is also configured as an elongated electrode. In some embodiments, the second electrode is located near the first elongated electrode. In some embodiments, when the elongated electrode 120B includes insulating segments, the elongated electrode 110 and the second electrode are represented by dashed lines of 110 and 120B.

[0030] In some embodiments, device 100 includes a disposable end (not shown) removably connectable to a handheld component and a housing, the disposable end including at least one first elongated electrode of a first polarity. In some embodiments, the disposable end also accommodates at least one second electrode of a second polarity. In some embodiments, the device is configured to supply or dispense an ingredient or substance into skin tissue. In some embodiments, the elongated electrode is configured to have one or more hollow channels for delivering the ingredient or substance into the skin tissue. The hollow channel 21 may be located within the elongated electrode 11, such as... Figure 6 As shown, elongated electrode 11 represents any elongated electrode (including 110 and 120B).

[0031] In some embodiments, the device further includes an actuation mechanism 130 configured to spatially move the first and / or second elongated electrodes along one or more axes. In some embodiments, a plurality of elongated electrodes are arranged in a comb-like one-dimensional array. In some embodiments, a plurality of comb-like one-dimensional arrays are arranged side-by-side with each other along a second axis to form a two-dimensional array of the first and / or second elongated electrodes.

[0032] Generally, a randomized distribution of graded treatments is advantageous for addressing specific skin tissue conditions. In some embodiments, the actuation mechanism 130 is further configured to arrange multiple elongated electrodes in any three-dimensional arrangement, for example, randomly distributed or distributed in the xy-plane according to a predetermined pattern and advancing into the skin tissue along the z-direction. In some embodiments, the actuator is also configured to rotate the elongated electrodes about their longitudinal axes. For example, the actuator can move the elongated electrodes into or out of the skin tissue a predetermined distance while rotating the elongated electrodes about their longitudinal axes.

[0033] In some embodiments, the second electrode is a flat electrode aligned at a specific angle (e.g., 90°) with respect to the longitudinal axis of the first elongated electrode. As a specific example, Figure 5 A flat second electrode 15 is shown, wherein an elongated first electrode 11 is at a 90° angle to the flat second electrode. The flat second electrode can be configured to contact the surface of the skin tissue site into which the first elongated electrode is inserted. In some embodiments, the flat second electrode is configured to be activated independently of the first elongated electrode. In some embodiments, the flat second electrode has perforations (…). Figure 4H 430A in Figure 4I The 440A in the middle, and Figure 5 (17) One or more of the first elongated electrodes pass through these holes on their way to the skin tissue site located below the flat second electrode.

[0034] In some embodiments, the second electrode is an elongated electrode 120B, configured as the first elongated electrode and operable for insertion into and withdrawal from skin tissue, such that current is applied to the interior of the skin tissue between the first and second elongated electrodes. It should be understood that in such cases, the second electrode, as part of the elongated electrode arrangement, forms part of the elongated electrode arrangement; in other words, all the features described herein with respect to the first elongated electrode apply to the second electrode. In this case, the second elongated electrode can be activated with opposite polarities in any order to apply current treatment to the skin tissue.

[0035] In some embodiments, the elongated electrodes in the first and / or second electrodes have equal or different lengths. In some embodiments, the elongated electrodes in the first and / or second electrodes have equal or different cross-sectional areas / shapes. In some embodiments, the elongated electrodes in the first and / or second electrodes are divided into two or more groups with different lengths or cross-sectional areas / shapes. In some embodiments, different groups of elongated electrodes are actuated by different activation modes.

[0036] In some embodiments, the device further includes a sensing system or mechanism 140 configured to provide sensing data indicative of at least one of skin tissue impedance, skin tissue mechanoimpedance, or any combination thereof. In some embodiments, the sensing mechanism 140 further includes a device-skin tissue alignment system 140C; an impedance sensing system 140A; and a skin tissue mechanoimpedance sensing system 140B. In some embodiments, at least a portion of the sensing system 140 is mounted on / embedded in an electrode (not shown) at the active portion (i.e., the location of the activating current) of at least one elongated electrode and / or at least one second electrode. In some embodiments, and in the case of impedance, the active portion of the electrode may form at least a portion of the sensing system.

[0037] In some embodiments, device 100 includes controller 150. In this publication, "controller" should be understood to mean one or more controllers or processors that may be hosted on a single computer, or whose features and functions may be distributed across multiple networked computers. In some embodiments, controller 150 also includes an associated user interface, including but not limited to a display or input device (which may include a keyboard and / or mouse (not shown)). In some embodiments, the controller is configured to: receive sensing data from sensing mechanism 140; control current source 160; and control actuation mechanism 130 to selectively apply at least one of skin tissue ablation, skin tissue coagulation, and mechanical skin tissue insertion to the treated skin tissue. In some embodiments, the controller is configured to apply skin tissue treatments, including skin tissue ablation, skin tissue coagulation, and mechanical skin tissue insertion, individually or in any combination thereof.

[0038] In some embodiments, in the case of an RF signal from a current source, the controller controls at least one of amplitude and frequency. In some embodiments, the controller manually or automatically controls and adjusts at least one of the RF amplitude and frequency of the current source based on real-time sensing data received from a sensing system. It is well known that, regardless of tissue type, impedance increases with depth and the distance between at least one elongated electrode and at least one second electrode. In some embodiments, the controller manually or automatically controls and adjusts at least one of the amplitude and frequency of the current source based on stored data or a lookup table related to tissue type according to depth (e.g., the depth of the elongated electrode).

[0039] In some embodiments, the controller is configured to control a current source and an actuation mechanism to cause movement of at least one elongated electrode within the skin tissue based on skin tissue ablation or mechanical insertion / puncture. In some embodiments, the skin tissue ablation or mechanical insertion / puncture is based on sensing data received from a sensing system, such as impedance measurements. In some embodiments, at least one controller is configured to alternately switch a current source on and off as at least one of the first and / or second elongated electrodes is moved within the skin tissue by the actuation mechanism according to one or more predetermined procedures, thereby causing treatment of the skin tissue along the propagation axis of at least one elongated electrode.

[0040] In some implementations, the impedance sensing system and controller are configured to determine the profile of the current (intensity and / or frequency) to achieve a desired localized skin tissue ablation or coagulation effect. For example, the controller may adjust the intensity and / or frequency to achieve predetermined lateral and / or three-dimensional localized skin tissue ablation or coagulation. For instance, increasing the frequency of the RF signal at a predetermined intensity selected to induce skin tissue coagulation will result in the coagulation area being closer to at least one first and / or second elongated electrode, and vice versa.

[0041] In some embodiments, the mechanical impedance measurement system and controller are configured to determine actuation mechanism parameters, such as the strength and / or frequency of the movement force and / or the rate of insertion into the skin tissue, to induce a desired profile of localized movement of the first and / or second elongated electrodes within the skin tissue. In some embodiments, the mechanical impedance is determined based on the current consumption of the actuation mechanism.

[0042] In some embodiments, the sensing system provides at least one of impedance or mechanical impedance sensing data indicating coupling or alignment between the device and the skin tissue to be treated, for example, as a safety measure. The controller can be configured to automatically activate a treatment session only once when the coupling / alignment condition is met, by activating an actuation mechanism to deploy at least one elongated electrode into the skin tissue and activating a current source to apply an ablation or coagulation treatment to the skin tissue. For example, the sensing system can measure mechanical impedance measurements by combining one or more of the following non-limiting examples: pressure sensors, velocity sensors, acoustic sensors, optical sensors. The sensing system can additionally or alternatively measure impedance measurements indicating coupling / alignment, such as via dedicated electrode sensors (not shown) located at the interface between the device and the skin tissue. In some embodiments, the coupling / alignment condition is that the entire surface of the device intersecting with the skin tissue is coupled / aligned without any air gap therebetween. In some embodiments, the controller is configured to automatically disconnect the current source and pull the first and second elongated electrodes out of the skin tissue once the coupling / alignment condition ceases to exist.

[0043] In some implementations, the controller is configured to activate the current source and the actuation mechanism in a periodic pattern. The actuation mechanism can be activated to deploy an elongated electrode into the skin tissue and then retract the elongated electrode from the skin tissue. Simultaneously, while the elongated electrode is within the skin tissue, the current source can be activated to apply treatment according to a predetermined pattern (e.g., continuously or intermittently). Sensing data (such as impedance data) received from the sensing system can be used by the controller to determine parameters of the actuation mechanism, such as deployment and retraction speeds (which can be constant or variable), and activation parameters of the current source, such as the intensity, frequency, and timing pattern of the processing current. In some implementations, the periodic pattern is such that it repeats at time intervals between each activation cycle to allow the user of the device to move the device between different skin tissue sites using a so-called “imprinting” method. In some implementations, controlling the current parameters (e.g., through a multi-pulse scheme) enables the avoidance of overall heating, undesirable overtreatment, and / or burns / damage to surrounding skin tissue.

[0044] exist Figure 2 The flowchart illustrates a non-limiting example of a method for grading skin tissue configured according to the subject matter disclosed herein.

[0045] Method 10a may include providing at least one first elongated electrode having a first polarity.

[0046] Method 10b may include providing at least one second electrode, the at least one second electrode being located near at least one first elongated electrode and having a second polarity opposite to that of the first elongated electrode.

[0047] Method 10c may include providing a current source connected to at least one first elongated electrode and at least one second electrode.

[0048] Method 10d may include providing an actuation mechanism that is at least connected to at least one first elongated electrode and configured to spatially move at least one first elongated electrode along one or more axes.

[0049] Method 10e may include contacting skin tissue with at least one first elongated electrode and at least one second electrode.

[0050] Method 10f may include the following two steps being applied sequentially a predetermined number of times by at least one controller:

[0051] Step f1 may include activating a current source by at least one controller to provide a current profile to at least one first elongated electrode and at least one second electrode for a predetermined first time period; and

[0052] Step f2 may include activating a current source by at least one controller and activating an actuation mechanism to move at least one first elongated electrode into or out of the skin tissue by a predetermined distance.

[0053] Method 10g may include activating an actuation mechanism by at least one controller to move at least one elongated electrode a second distance. In some embodiments, method 10g may be completed during step (f1).

[0054] Method 10h may include adjusting the current profile by at least one controller based on sensing data. Method 10g may be completed during step (f1).

[0055] In some implementations, the above method may include an RF power source that activates a current source to ablate skin tissue, and a DC power source that activates after the elongated electrode is located inside the skin tissue.

[0056] In some embodiments, and when the elongated electrode is rotated, the activation mode can result in directional thermal damage to the skin tissue in both the xy direction (due to rotation) and the z direction (due to propulsion into or out of the skin tissue). In some embodiments, the thermal damage can have a helical shape, i.e., a three-dimensional helical curve. In some embodiments, the elongated electrode includes multiple conductive points along multiple insulating surfaces, as described below. Therefore, more complex treatment profiles, such as double-helix or triple-helix thermal damage regions, can be achieved as needed.

[0057] exist Figure 3 The figure illustrates different examples of the tissue effects of grading treatments on skin tissue according to different aspects of the subject matter described herein. For simplicity, the figure shows different tissue effects of grading treatment performed by an elongated electrode having an opposite polarity to a second flat electrode positioned on the skin tissue surface TS (neither the elongated electrode nor the flat monopole is shown). The grading treatment effect propagates along the axis of the elongated electrode within and beside the skin tissue. As another aspect of the invention, exemplary skin tissue effects can be obtained based on transient skin tissue impedance measurements performed at the end of the elongated electrode.

[0058] At skin tissue region TZ1, skin tissue ablation TA1 is achieved using appropriate electrical energy. At skin tissue region TZ2, skin tissue mechanical insertion TI1 is achieved by puncturing the skin tissue using a thin electrode that is mechanically moved to the skin tissue. At skin tissue region TZ3, skin tissue coagulation TC1 is achieved using appropriate electrical energy. At skin tissue region TZ4, skin tissue mechanical insertion TI2, with a length longer than TZ2, is achieved by puncturing the skin tissue using a thin electrode that is mechanically advanced. At skin tissue region TZ5, skin tissue ablation TA2 and directional skin tissue coagulation TC2 are achieved using appropriate electrical energy. According to one aspect of the invention, coagulation energy can be applied before ablation energy, and according to another aspect of the invention, ablation energy can be applied before coagulation energy. According to the invention, different combinations of mechanical puncture length, ablation electrode insertion, and coagulation tissue region can be applied.

[0059] exist Figures 4A to 4G The image shows a non-limiting example of a first and / or second elongated electrode configured according to the subject matter disclosed herein.

[0060] Figures 4A to 4C This is a side view showing the insulation of the outer surface of the elongated electrode. In some embodiments, the elongated electrode is completely or partially insulated along its proximal outer surface.

[0061] Figure 4A An insulating profile 412A is shown, extending the entire length L of the elongated electrode 410A. A conductive, uninsulated portion 414A is located on the underside of the elongated electrode. In an embodiment, current exits the elongated electrode only at the underside in the direction of its propagation axis. Note that current flows between the underside 414A of the elongated electrode and at least one second electrode. When the latter is a flat electrode placed on the surface of the skin tissue site, current flows between a small area (and therefore a high current density) at the end of the elongated electrode and a large area (and therefore a low current density) of the flat second electrode. This configuration results in a higher and more controllable precision tissue effect near the end of the elongated electrode and a lower or negligible tissue effect adjacent to the flat second electrode. When the latter is another elongated electrode inserted into the skin and adjacent to the first elongated electrode and having opposite polarity during RF application, the treatment effect on the tissue adjacent to the ends of the paired elongated electrodes can be achieved by ablation and / or coagulation.

[0062] Figure 4BAn insulating profile 412B is shown, extending for most of the length of the elongated needle electrode 410B. A conductive portion 414B extends along a portion of the length of the needle electrode and its underside. In some embodiments, the elongated electrode is insulated along its entire outer surface, except for one or more elongated strips extending proximally from the bottom end of the elongated electrode. Typically, this configuration results in the directional flow of current into / out of the elongated electrode.

[0063] Figure 4C An elongated electrode, insulated over its entire outer surface, is shown, except for a longitudinal strip 414C that remains uninsulated and therefore conductive. In some embodiments, the actuation mechanism is further configured to selectively rotate the elongated electrode about its longitudinal axis to select the direction of current flow from strip 414C to its paired second electrodes, which have opposite polarities during RF operation. Such second electrodes may be flat electrodes located on the skin surface and / or one or more adjacent elongated electrodes. In some embodiments, at least one controller determines the directional flow of current to achieve the desired treatment effect based on impedance measurements.

[0064] In some embodiments, the elongated electrode includes an insulating outer elongated member and at least one inner conductive elongated member, the at least one inner conductive elongated member being controllably protruding from the insulating outer elongated member (not shown). In some embodiments, the inner conductive elongated member is resilient but still capable of penetrating skin tissue by ablation and / or mechanical means. This configuration allows for control of the effective conductive portion of the elongated electrode by projecting the desired length of the inner conductive elongated member distally from the insulating outer elongated member.

[0065] In some embodiments, the insulating outer elongated member includes a grooved portion in the form of an elongated strip extending distal to the insulating outer elongated member, such as... Figure 4C As shown in 414C. The insulating outer elongated member can be rotated relative to the inner conductive elongated member by an actuating mechanism, thereby allowing the desired side of the inner conductive elongated member to pass through the elongated strip to control the directional flow and intensity / density of the current.

[0066] In some embodiments, the first and / or second elongated electrodes have flat side bodies, for example, with a rectangular or polygonal cross-sectional shape, such as... Figure 4E As shown. Figure 4E The rectangular cross-section of the electrode is shown in more detail.

[0067] In some embodiments, the first and / or second elongated electrodes have curved side bodies, such as the circular (circular or elliptical) cross-section of the electrodes, as... Figure 4D As shown.

[0068] In some implementations, the elongated first and / or second electrodes have blunt distal ends, such as Figure 4F The flattened distal end 410T1 is shown in the figure. The blunt distal end can be flat or curved.

[0069] In some implementations, the elongated electrode has a sharp or pointed distal end configured for puncturing skin tissue, such as Figure 4G The sharp end 410T2 is shown in the figure.

[0070] Figure 4H This is a bottom view of a single flat second electrode 420A and, for example, an array of six first elongated electrodes 410D (which pass through a hole 430A formed in the single flat second electrode) as described above. These six elongated electrodes are electrically isolated from the flat second electrode. At any given time, any number of the first elongated electrodes can be activated relative to the single flat second electrode. In another example, at least some of these six elongated electrodes can be activated with opposite polarities; that is, some of them function as second elongated electrodes.

[0071] Figure 4I Two flat second electrodes 420B1 and 420B2 are shown, each having three holes 440A through which two arrays 410E1 and 410E2, consisting of three first elongated electrodes, pass. In addition... Figure 4H In addition to the possibility of this, it also makes it possible to activate the two flat second electrodes relative to each other, and to activate the two flat second electrodes relative to an array of elongated electrodes passing through the other flat second electrode.

[0072] Therefore, the subject matter disclosed herein enables customized grading of skin tissue based on local skin tissue impedance (electrical and / or mechanical) measurements, including any combination of ablation, coagulation, and mechanical insertion.

[0073] To aid understanding, detailed descriptions may include the use of introductory phrases such as “at least one / at least one” and “one or more / one or more”. However, the use of such phrases should not be construed as implying that the introduction of the indefinite article “a” or “a” limits any particular embodiment containing such phrases to a disclosure containing only one such statement, even when it includes the introductory phrases “one or more / one or more” or “at least one / at least one” and indefinite articles such as “a” or “a” (e.g., “a” and / or “a” should generally be interpreted as meaning “at least one / at least one” or “one or more / one or more”); the same applies to the use of definite articles used to introduce descriptions. Furthermore, even when a specific number of introduced descriptions is explicitly stated, those skilled in the art will recognize that such statements should generally be interpreted as meaning at least the number stated (e.g., an unmodified statement of “two statements” in the absence of other modifiers generally means at least two statements, or two or more statements).

Claims

1. A skin tissue treatment device, comprising: a current source configured to provide alternating current (AC), direct current (DC), or any combination thereof; at least one first elongated electrode having a first polarity and configured to receive a current from the current source and for insertion into the skin tissue to one or more depths; at least one second electrode located in proximity to the at least one first elongated electrode and configured to receive the current from the current source at a second polarity opposite to the at least one first elongated electrode; an actuation mechanism connected to at least the at least one first elongated electrode and configured to spatially move the first elongated electrode along one or more axes; at least one controller connected to the at least one first elongated electrode, the at least one second electrode, the current source, and the actuation mechanism; and the at least one controller is configured to: control the current source; cause the actuation mechanism to actuate; and selectively apply a treatment of skin tissue ablation, skin tissue coagulation, or skin tissue mechanical insertion to the skin tissue.

2. The device of claim 1, further comprising a handpiece configured to be held by a user, and the handpiece comprises: the at least one first elongated electrode; the at least one second electrode; and the actuation mechanism.

3. The device of claim 2, wherein the handpiece further comprises a disposable tip removably connectable to the handpiece, wherein the disposable tip comprises at least one of: the at least first elongated electrode; or the at least one second electrode.

4. The device of claim 1, further comprising a sensing system configured to transmit sensing data of the skin tissue to the controller, wherein the sensing data is indicative of at least one of electrical impedance or mechanical impedance.

5. The device of claim 1, wherein the at least one second electrode is configured to at least one of: an elongated shape configured to penetrate into the skin tissue; a flat shape configured to contact a surface of the skin tissue; or a flat shape with perforations configured to pass the at least one first elongated electrode through to the skin tissue.

6. The device of claim 1, wherein a plurality of the at least one elongated electrode is configured as a comb-like one-dimensional array.

7. The device of claim 6, wherein a plurality of the comb-like one-dimensional arrays are arranged side-by-side with each other along a second axis forming a two-dimensional array of the at least one elongated electrode.

8. The device of claim 1, wherein the at least one elongated electrode is configured to have at least one of a plurality of insulating patterns on a surface, and further comprising a plurality of conductive points along the plurality of insulating patterns.

9. The device of claim 8, wherein the plurality of insulating patterns are configured in an elongated shape on the at least second electrode.

10. The device of claim 1, wherein the actuator is additionally configured to rotate the at least one elongated electrode about a longitudinal axis of the at least one elongated electrode.

11. A skin tissue treatment method, comprising: ​ ​ providing a current source configured to provide an alternating current (AC), a direct current (DC), or any combination thereof; providing at least one first elongated electrode having a first polarity and configured to receive a current from the current source and to be inserted into the skin tissue to one or more depths; providing at least one second electrode located in proximity to the at least one first elongated electrode and configured to receive the current from the current source at a second polarity opposite to the at least one first elongated electrode; providing an actuation mechanism connected to at least the at least one first elongated electrode and configured to spatially move the first elongated electrode along one or more axes; providing a connection to the at least one first elongated electrode, the at least one second electrode, the current source, and the actuation mechanism; and providing at least one controller; placing the at least one elongated electrode and the at least one second electrode in contact with the skin tissue; selectively activating, by the at least one controller: the current source to apply a current profile to at least one of the at least one first elongated electrode or the at least one second electrode, and the actuation mechanism to move the at least one elongated electrode into or out of the skin tissue by a predetermined distance, wherein a treatment of skin tissue ablation, skin tissue coagulation, or skin tissue mechanical insertion is selectively applied to the skin tissue.

12. The method of treating skin tissue of claim 11, further comprising: activating, by the at least one controller, the current source to provide a current profile to the at least one first elongated electrode and the at least one second electrode for a predetermined first time period; deactivating, by the at least one controller, the current source; activating, by the at least one controller, the actuation mechanism to move the at least one elongated electrode into or out of the skin tissue by a predetermined distance; and activating, by the at least one controller, the actuation mechanism to move the at least one elongated electrode by a second distance.

13. The method of claim 11, wherein the method further comprises: providing a sensing system configured to transmit sensing data indicative of at least one of an electrical impedance or a mechanical impedance of the skin tissue; and adjusting, based on the sensing data and by the at least one controller, at least one of: a current received by the at least one first elongated electrode, or a current received by the at least one second electrode, or activating the actuation mechanism.

14. The method of claim 13, wherein the method further comprises: adjusting, based on the sensing data and by the at least one controller, the received current to selectively apply skin tissue ablation or skin tissue coagulation.

15. The method of claim 11, wherein: a plurality of the at least one elongated electrode is provided and divided into two or more groups of elongated electrodes; and ​ ​ ​ The method further includes actuating, by the at least one controller, the two or more groups so as to move into and out of the skin tissue in different activation patterns.

16. The method of claim 15, wherein the plurality of the at least one elongated electrode can comprise at least one of: equal lengths; different lengths; equal cross-sectional areas or shapes; or different cross-sectional areas / shapes.

17. The method of claim 11, wherein the actuation mechanism is configured to additionally cause the at least one elongated electrode to rotate about a longitudinal axis of the at least one elongated electrode; and the method further includes causing, by the at least one controller, the actuation mechanism to actuate to cause the at least one elongated electrode to move into or out of the skin tissue a predetermined distance while the at least one elongated electrode is rotating about the longitudinal axis of the at least one elongated electrode.

18. The method of claim 11, wherein the at least one second electrode is configured in a flat shape having a perforation configured to pass the at least one first elongated electrode through; and the method further includes causing, by the at least one controller, the actuation mechanism to actuate to move the at least one elongated electrode a predetermined distance through the perforation into the skin tissue.

Images