Non-invasive, uniform and non-uniform RF methods and systems related applications

Abstract

Provided herein are systems and methods for treating a patient's skin or other target tissue using RF energy. In various aspects, the methods and systems described herein can provide RF-based treatments in which the RF energy can be selectively controlled to promote heating uniformity during one or more of body sculpting treatments (lipolysis), skin tightening treatments (laxity improvement), and cellulite treatments, all as non-limiting examples. In various aspects, the system can include: a flexible applicator comprising a plurality of layers, the plurality of layers comprising a first dielectric layer, a second dielectric layer, and a conductive layer, wherein the conductive layer is sandwiched between the first dielectric layer and the second dielectric layer, the plurality of layers defining a plurality of incisions; an interior region and N regions extending from the interior region, wherein the plurality of incisions divide the applicator into N regions.

Description

[0001] Related applications

[0002] This application is a continuation-in-part of U.S. patent application No. 16 / 238,483, filed on January 2, 2019, which is a continuation-in-part of U.S. patent application No. 15 / 640,710, filed on July 3, 2017, and claims the benefit of priority to U.S. Provisional Application No. 62 / 357,920, filed on July 1, 2016, and U.S. Provisional Application No. 62 / 514,778, filed on June 2, 2017, each of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to systems and methods for treating a patient's skin (e.g., dermis and hypodermis) and other target tissue, including tissue located at a depth below the tissue surface, using radiofrequency (RF) energy. Background Art

[0004] Electrosurgical devices are known for applying RF energy to tissue to produce a variety of effects, including invasive procedures (e.g., for ablating, removing, burning, or vaporizing tissue) or minimally invasive procedures (e.g., for slightly heating the skin surface). However, there remains a need for improved methods and systems for providing uniform and large-area RF energy application in cosmetic and / or beauty applications, for example, to improve the appearance of skin by tightening / smoothing it and / or reducing fat present in subcutaneous tissue (e.g., subcutaneous tissue). Summary of the Invention

[0005] Described herein are systems and methods for treating a patient's skin (e.g., dermis and hypodermis) with RF energy or treating other target tissue located at a depth below the tissue surface with RF energy. In various aspects, the present teachings can provide a non-invasive, cooled (or non-cooled), RF-based treatment to achieve one or more of the following as non-limiting examples: body sculpting (lipolysis), skin tightening (laxity improvement), cellulite treatment devices, vaginal laxity treatment or restoration, urinary incontinence treatment, fecal incontinence treatment, and treatment of other genitourinary disorders.

[0006] In various aspects, non-invasive treatment of unwanted fat, improvement of skin laxity / firmness, and improvement of the appearance of cellulite can be achieved via a water-cooled treatment electrode or electrode array operating in monopolar or bipolar mode by applying RF energy (e.g., 500 kHz, 1 MHz, or other) delivered to the surface of a patient's tissue (e.g., skin, vaginal wall, esophagus), from which the RF energy propagates into deeper tissue layers. According to various aspects of the present teachings, cooling superficial layers and selectively controlling the deposition of RF energy can heat tissue beneath the surface and can help ensure heating uniformity, patient safety and tolerability, and consistent clinical results.

[0007] According to various aspects of the present teachings, the systems and methods described herein may be one or more of the following:

[0008] 1. User-friendly and / or hands-free (e.g., after initial setup);

[0009] 2. Improving patient tolerance by cooling the upper layer of tissue and / or modulating RF energy and / or modulating cooling to improve patient safety and / or comfort; and

[0010] 3. Be flexible to accommodate various anatomical features.

[0011] As a non-limiting example, various systems and methods according to the present teachings can be used in a hands-free manner such that one or more RF applicators can be applied to a patient at the beginning of a treatment, energized, and optionally left unattended until the procedure is complete (e.g., a patient can be treated largely unattended, e.g., for at least up to 5 minutes or at least up to 10 minutes after initial setup). In various aspects, the methods and systems described herein can include a cooling system (e.g., via circulation of chilled temperature-controlled water adjacent to the RF source and / or electrode array) to provide patient safety (e.g., to avoid burns to the skin and / or formation of nodules in the tissue following thermal treatment of the tissue), enhance patient comfort, and / or increase patient tolerance to the potentially painful effects of RF energy during treatment in accordance with FDA and IEC safety recommendations. In various aspects, the methods and systems described herein can be sufficiently flexible and / or adaptable to be able to treat a variety of desired locations on a patient's body (e.g., the abdomen, the submental area, any of multiple facial regions, the arms, the legs), despite anatomical differences, varying surface areas, and complex curvatures between and within patients that may make it difficult to maintain contact for the time required to complete the treatment.

[0012] According to various aspects of the present teachings, a system for treating patient tissue is provided, the system comprising an RF energy source and a treatment applicator having: a plurality of treatment electrodes configured to be arranged in contact with a surface of a patient's tissue (e.g., a skin surface, a mucosal surface) and deliver RF energy to the patient's tissue surface; and a return electrode. The plurality of treatment electrodes may include at least two individually addressable treatment electrodes, to which different treatment RF signals may be applied, the RF signals exhibiting one or more of power, duty cycle, pulse duration, phase, and RF frequency. The system may also include a controller configured to determine an impedance of each of the at least two individually addressable treatment electrodes, wherein the controller is further configured to adjust the treatment RF signals simultaneously applied to the at least two individually addressable treatment electrodes based on their impedances so as to maintain uniform heating in the target tissue beneath the treatment applicator. Optionally, in some aspects, the system may also include a cooling mechanism for cooling the tissue surface in contact with the plurality of electrodes. In various aspects, at least one return electrode can be positioned on the surface of the skin or internally (eg, within the urethra).

[0013] In some aspects, the different RF signals applied simultaneously to the at least two individually addressable treatment electrodes can include one or more of different powers, pulse widths, duty cycles, phases, and RF frequencies. In some related aspects, the controller can be configured to reduce the power of the RF signal to the electrode of the at least two individually addressable treatment electrodes that exhibits a lower impedance.

[0014] In various aspects, the at least two individually addressable treatment electrodes can include at least two groups (e.g., clusters) of individually addressable treatment electrodes, wherein each treatment electrode in each group of individually addressable treatment electrodes has the same RF signal applied simultaneously to the treatment electrode as the other treatment electrodes in the group, and wherein each group of individually addressable treatment electrodes is configured to have a different RF signal applied simultaneously to the treatment electrodes.

[0015] In some aspects according to the present teachings, the system can further include a second treatment applicator configured to be arranged to contact a tissue surface spaced apart from the tissue surface on which the first treatment applicator is positioned. In some aspects, the second treatment applicator can represent the at least one return electrode, however the return electrode can also be a separate electrode. Optionally, the second treatment applicator can include a cooling mechanism for cooling the tissue surface in contact with the plurality of electrodes of the second treatment applicator. In some aspects, the second treatment applicator can include a second plurality of treatment electrodes configured to be arranged to contact and deliver RF energy to the tissue surface of the patient, wherein the second plurality of treatment electrodes includes at least two individually addressable treatment electrodes to which different RF signals can be applied. In these aspects, the controller can, for example, be configured to activate only one of the individually addressable treatment electrodes on each of the first treatment applicator and the second treatment applicator at a given time. In addition, the controller can be configured to determine the impedance between each of the at least two individually addressable treatment electrodes of the first treatment applicator and each of the at least two individually addressable treatment electrodes of the second treatment applicator (e.g., by polling one electrode from each applicator at a time). For example, the controller can be configured to determine the impedance between each of the at least two individually addressable treatment electrodes of the first treatment applicator and each of the at least two individually addressable treatment electrodes of the second treatment applicator by generating a sub-treatment threshold RF current therebetween prior to applying a treatment RF signal to the first plurality of electrodes. Additionally or alternatively, in some aspects, the controller can be configured to determine the impedance between each of the at least two individually addressable treatment electrodes of the first treatment applicator and each of the at least two individually addressable treatment electrodes of the second treatment applicator while applying a treatment RF signal to the first plurality of electrodes, so as to determine when to terminate treatment by terminating the treatment RF signal.

[0016] The return electrode can have various configurations. For example, the return electrode can be a passive electrode configured to be arranged to contact a tissue surface spaced apart from the tissue surface on which the first treatment applicator is disposed. For example, the passive electrode can be a neutral drain pad. In some related aspects, in addition to the return electrode, a second treatment applicator can be provided, the second treatment applicator configured to be arranged to contact a tissue surface spaced apart from the tissue surface on which the first treatment applicator and the passive electrode are disposed, wherein the second treatment applicator includes a second plurality of treatment electrodes configured to be arranged to contact the tissue surface of the patient and deliver RF energy to the tissue surface of the patient.

[0017] In various aspects, the controller can be configured to separately poll each of the at least two individually addressable treatment electrodes of the first treatment applicator with a low power sub-treatment threshold RF signal.

[0018] Various treatments can be provided according to the methods and systems of the present teachings. For example, the RF treatment signal can be configured to reduce skin laxity by stimulating collagen production and / or lipolysis (e.g., by substantial heating) in adipose tissue beneath the tissue surface. For example, each electrode can be configured to deliver approximately 1 W / cm 2 to about 5W / cm 2 The RF power is in the range of about 10 J / cm2, wherein the RF signal has a pulse width greater than about 1 second. Additionally or alternatively, the RF treatment signal can be configured to reduce the appearance of cellulite. For example, each electrode can be configured to deliver a signal exhibiting about 10 J / cm2. 2 to about 1000 J / cm 2 The RF pulses each have a pulse energy within a range of about 1000 ms, and wherein the RF signal has a pulse width of less than about 500 ms.

[0019] According to the present teachings, the cooling mechanism can have various configurations. For example, the cooling mechanism can include a circulating fluid, a thermoelectric element, or a phase change material disposed in the applicator in thermal contact with the electrode. In certain aspects, the cooling mechanism can include a circulating fluid, wherein the temperature of the circulating fluid is controlled by a temperature regulator (e.g., under the influence of a controller) such that the target tissue area disposed can include a temperature maintained below the tissue surface in the range of about 42°C to about 47°C during a treatment time in the range of about 10 minutes to about 30 minutes. In some aspects, the circulating fluid can include water. In various aspects, at least a portion of the fluid path of the circulating fluid can be in thermal contact with a side of the electrode that is not configured to contact the tissue surface. Additionally or alternatively, at least a portion of the fluid path of the circulating fluid can be in thermal contact with the tissue surface at a location between adjacent electrodes of the plurality of treatment electrodes.

[0020] In various aspects, the system may further include one or more temperature detectors for detecting the temperature of the tissue surface around the perimeter of the electrode array, wherein the controller is further configured to adjust the RF signal applied to the electrodes on the side of the applicator exhibiting the highest temperature (e.g., reduce the power of the treatment RF signal). Additionally or alternatively, the controller may be configured to adjust the RF signal applied to the electrodes on the side of the applicator opposite to the side of the applicator exhibiting the lowest temperature (e.g., increase the power of the treatment RF signal).

[0021] In some aspects, the RF energy source can include two or more individually controllable RF energy sources, each configured to operate at the same fundamental frequency, but the RF signals generated thereby can have different phases and amplitudes. In these aspects, the system can include two or more treatment applicators, each associated with one of the RF energy sources, wherein current can be shared between each of the two or more treatment applicators such that the two or more applicators can be positioned over two or more different treatment areas of a subject's body, and each of the two or more applicators can be configured to deliver an appropriate amount of RF energy to each of the different treatment areas.

[0022] According to various aspects of the present teachings, a system for treating patient tissue is provided, the system comprising: an RF energy source; a treatment applicator comprising a treatment electrode configured to be positioned in contact with and deliver RF energy to a tissue surface of the patient; and at least one return electrode. The system may also comprise: a controller configured to provide an RF signal to the treatment electrode, the RF signal having a pulse duration that selectively heats a membrane within the adipose tissue while substantially avoiding conduction of heat into adjacent tissue; and an impedance tracker for monitoring the patient's tissue impedance during the pulse duration and for providing information to the controller regarding changes in the patient's tissue impedance so that the controller can terminate the RF signal upon completion of the desired treatment. Optionally, the system may comprise a cooling mechanism for cooling the tissue surface in contact with the electrode.

[0023] In various related aspects, the treatment electrode can be configured to deliver a dose of about 10 J / cm 2 to about 500 J / cm 2 , wherein the RF pulses have a pulse energy of each within a range of , wherein the RF signal has a pulse width of less than about 500 ms. In some aspects, the controller may also be configured to adjust the RF signal provided to the plurality of electrodes so that a second treatment RF signal is provided to each of the plurality of electrodes simultaneously, wherein the second RF signal includes a lower RF power and a longer pulse width relative to the RF treatment signal for selectively heating the diaphragm. For example, the second RF treatment signal may be configured to reduce skin laxity and / or cause fat decomposition (e.g., after or before selectively targeting the diaphragm). In various aspects, the second RF treatment signal may be configured so that each electrode simultaneously delivers approximately 1 W / cm 2 to about 5W / cm 2 The RF power is within a range of 100 kHz to 200 kHz, wherein the RF signal has a pulse width greater than about 1 second.

[0024] According to various aspects of the present teachings, a system for treating patient tissue is provided, the system comprising an RF energy source and a treatment applicator, the treatment applicator comprising a plurality of treatment electrodes configured to be disposed in contact with and deliver RF energy to a tissue surface of the patient, wherein the plurality of treatment electrodes comprises at least two individually addressable treatment electrodes to which a treatment RF signal may be applied. In some aspects, the system may further comprise at least one return electrode and an optional cooling mechanism for cooling the tissue surface in contact with the plurality of electrodes. A controller may be provided, the controller being configured to sequentially provide a treatment RF signal to each of the at least two individually addressable treatment electrodes such that each of the at least two individually addressable treatment electrodes is configured to selectively heat a membrane within the adipose tissue while substantially avoiding conduction of heat into adjacent tissue. In some aspects, each of the at least two individually addressable treatment electrodes may be configured to deliver a RF signal having a RF energy content of approximately 10 J / cm 2 to about 500 J / cm 2 , and wherein the RF signal has a pulse width of less than about 100 ms. In addition, the controller can also be configured to adjust the RF signal provided to the plurality of electrodes so that a second treatment RF signal is provided to each of the plurality of electrodes at the same time, wherein the second RF signal includes a lower RF power and a longer pulse width relative to the RF treatment signal for selectively heating the diaphragm. For example, the second RF treatment signal can be configured to reduce skin laxity and / or cause fat decomposition. In some aspects, each electrode subjected to the second RF treatment signal can simultaneously deliver approximately 1 W / cm 2 to about 5W / cm 2 The RF power is within a range of 100 kHz to 200 kHz, wherein the RF signal has a pulse width greater than about 1 second.

[0025] According to various aspects of the present teachings, there is provided a device for treating female urogenital system disorders, the device comprising: a probe adapted for insertion into the vagina, the probe having a distal end configured to apply heat to at least a portion of the vaginal wall surface; and a plurality of radio frequency (RF) energy radiation treatment electrodes arranged in an array at the distal end of the probe to heat tissue in contact with or near the probe. At least one temperature sensor may also be incorporated into the probe to monitor the temperature of the vaginal wall surface and / or the target tissue. In various aspects, the temperature sensor may be an infrared (IR) sensor configured to detect blackbody radiation emitted by heated tissue, or may be implemented by one or more electrodes operating as impedance measurement electrodes. Optionally, the probe may also include one or more cooling circuits to avoid overheating of the vaginal wall surface.

[0026] In some aspects, the electrodes are programmable (e.g., under the influence of a controller) such that a subset of the array components can be activated to deliver heat in a specific pattern. In various aspects, the device can also include one or more return electrodes to provide a return path for the RF current from the treatment electrode. For example, the return electrode can be a drain pad (e.g., a neutral plate) adapted to be placed on an external surface of the patient's body (e.g., the skin surface). Alternatively, the return electrode can be placed in a urinary catheter. Alternatively, the return electrode can be implemented by one or more electrodes in the array that serve as ground electrodes.

[0027] In some aspects, a fixing device may also be provided to facilitate insertion of the probe and / or to hold the probe in place when inserted into the patient. For example, the fixing device may include a locking sleeve or a balloon.

[0028] According to various aspects of the present teachings, a method for treating female urogenital disorders is provided. For example, in various aspects, a method for treating stress urinary incontinence (SUI) is provided, the method comprising: delivering a controlled amount of heat to the vaginal wall surface to reshape tissue in a target area adjacent to the patient's bladder neck or urethra. In various aspects, heating can be performed by activating one or more radio frequency (RF) energy emitting treatment electrodes in contact with the vaginal wall surface to transmit RF current into the target area. In certain exemplary aspects, the treatment electrode may include an electrode array carried by a probe, the method further comprising: inserting the probe into the patient's body so that at least one treatment electrode contacts at least a portion of the vaginal wall surface. In certain aspects, the power delivered by each electrode in the array can be varied to ensure uniform heating of the tissue in the target area. In some aspects, the electrode can be configured to contact at least a portion of the anterior vaginal wall, and / or the method may further comprise: delivering RF energy to heat the tissue between the patient's vaginal wall surface and the urethra. For example, the method may further include delivering RF energy to heat tissue in a target area extending to a treatment depth of about 2 to 9 cm, preferably about 5 to 8 cm, beyond the surface of the inner wall of the vagina.

[0029] In some related aspects, RF energy can be delivered to heat the tissue in the target area for a period of time, preferably less than 30 minutes, or less than 10 minutes, or in some cases less than five minutes. Furthermore, in some aspects, the target tissue can be heated to about 40° C. to 45° C., or about 41° C. to 43° C. Optionally, the method can include cooling the vaginal wall surface before, after, or during heating of the tissue in the target area.

[0030] In various aspects, the method may further include mapping the thermal effects of the RF electrode by thermography or impedance measurements.

[0031] According to various aspects of the present teachings, a system for treating patient tissue is provided, the system comprising: an RF energy source; a treatment applicator comprising a treatment electrode configured to be placed in contact with a patient's tissue surface (e.g., a treatment probe configured for insertion into a patient's vagina, the treatment probe having one or more treatment electrodes) and delivering RF energy to the patient's tissue surface; and at least one return electrode. The system may also include a controller configured to provide an RF signal to the treatment electrode, the RF signal having a certain pulse duration, and the treatment electrode is sized to apply a current density sufficient to ablate the tissue surface in contact with the treatment electrode. Optionally, a cooling mechanism for cooling the tissue surface in contact with the electrode is provided. In various aspects, the pulse duration can be less than about 100 ms. (e.g., in the range of about 5 ms to about 35 ms). In various aspects, the treatment electrode can have a size in the range of about 0.1 mm to about 10 mm, or about 0.1 mm to about 5 mm.

[0032] In various aspects, the system may further include a second treatment electrode, the second treatment electrode may be positioned adjacent to the treatment electrode, the controller further configured to provide the RF signal to the second treatment electrode, the RF signal having a pulse duration, and the second treatment electrode being sized to apply a current density sufficient to ablate the tissue surface in contact with the treatment electrode. In various aspects, the spacing between the treatment electrode and the second electrode may be in the range of about 0.1 mm to about 10 mm or about 0.5 mm to about 5 mm. In some related aspects, the treatment electrode may be addressed by the controller simultaneously with the second treatment electrode.

[0033] In various aspects, the treatment electrode can include a cluster of two or more electrodes, each electrode in the cluster having a size ranging from about 0.1 mm to about 10 mm, or about 0.1 mm to about 5 mm. In these aspects, each of the two or more electrodes in the cluster can be sized to apply a current density sufficient to ablate the tissue surface in contact with each treatment electrode in the cluster. Additionally, in some aspects, a second cluster of two or more electrodes can be provided, the controller being configured to provide the RF signal to the second cluster, and the RF signal having a certain pulse duration, and each of the two or more electrodes in the second cluster being sized to apply a current density sufficient to ablate the tissue surface in contact with each treatment electrode in the second cluster. In various aspects, the controller can address the cluster and the second cluster separately.

[0034] According to various aspects of the present teachings, a system for treating patient tissue is provided, the system comprising: two or more treatment applicators, each of the treatment applicators being adapted to be positioned on a tissue surface; and two or more individually controllable RF energy sources. In exemplary aspects, each of the individually controllable RF energy sources can operate at the same fundamental frequency, but the phase and amplitude of each of the two or more RF energy sources can be controllable relative to each other. In these aspects, each of the two or more treatment applicators can be associated with its own individually controllable RF energy source such that current can be shared between the two or more treatment applicators such that the two or more applicators can be placed on two or more different treatment areas of a subject's body, and each of the two or more applicators can deliver an appropriate amount of RF energy to each of the different treatment areas. In various aspects, the system can also include a return electrode. Furthermore, in certain aspects, each treatment applicator can include a plurality of treatment electrodes configured to be positioned in contact with and deliver RF energy to a tissue surface of a patient, wherein the plurality of treatment electrodes include at least two individually addressable treatment electrodes to which an RF signal can be applied.

[0035] According to various aspects of the present teachings, a radio frequency (RF)-based treatment system includes: an RF transmission cable comprising a plurality of electrical leads and an RF input port; and a first applicator. The first applicator includes a plurality of electrical contacts, the plurality of electrical contacts being in electrical communication with the plurality of electrical leads. The system may also include a first support, the first support including a tissue-facing surface and a bottom surface, the tissue-facing surface defining a first shape and an array of K individually addressable electrodes, the array of K individually addressable electrodes being disposed in or on the first support and arranged relative to the tissue-facing surface, each of the K electrodes being in communication with at least one of the electrical contacts. In one embodiment, K is a positive integer.

[0036] In various aspects, the system can include a first support that can be a first flexible substrate. In some aspects, the system can include electrical contacts, and each addressable electrode can be flexible and can be disposed on the first support. Optionally, in some aspects, the RF-based processing system includes a second support that can include a second flexible material, wherein the second support can be disposed on or above the bottom surface.

[0037] In various aspects, the RF-based treatment system may include a second flexible material that may be an elastically compressible foam material. Optionally, in some aspects, the RF-based treatment system may include a fluid-based cooling device, the fluid-based cooling device defining one or more coolant flow channels, the cooling device being disposed below the tissue-facing surface. In some aspects, the RF-based treatment system may include a coolant flow channel sized to reduce tissue surface heating when the array is activated during tissue treatment. In some aspects, the RF-based treatment system may include a cooling device comprising one or more connectors extending from the cooling device, the cooling device being sandwiched between the first support member and the foam material.

[0038] In many aspects, the RF-based treatment system can include a first support that can be a flexible polymer substrate, wherein the plurality of electrical contacts are disposed on one or more edges of the polymer substrate. In some aspects, the RF-based treatment system can include an applicator kit comprising a first applicator and M applicators, wherein each of the M applicators can be substantially identical to the first applicator, wherein the first shape of each applicator can be selected such that M+1 applicators can tile a tissue treatment surface when placed adjacent to each other. In one embodiment, M can range from 1 to 1000. In one embodiment, M is a positive integer.

[0039] In various aspects, the RF-based treatment system can include one or more temperature sensors arranged in a pattern to measure the temperature of the tissue during treatment, wherein the one or more temperature sensors can communicate with one or more of the plurality of electrical contacts. In some aspects, the RF-based treatment system can include an adhesive layer disposed on or near the skin-facing surface to temporarily attach the applicator to the skin. In certain aspects, the RF-based treatment system can include an upper housing portion disposed on the foam, wherein the upper housing portion includes an attachment member.

[0040] In many aspects, the RF-based processing system can include the RF transmission cable having a cable length CL between the RF input port and the electrode array, wherein CL ranges from about 1 foot to about 40 feet. In some aspects, the RF-based processing system can include a first control node disposed between the RF input port and the electrode array and in electrical communication with the RF input port and the electrode array. In some aspects, the RF-based processing system can include the first control node, the first control node including a first controller, wherein the first controller generates control signals to turn "on" and "off" individual electrodes in the electrode array.

[0041] In various aspects, the RF-based treatment system can include a distance Y between an output of a first control node along an RF transmission cable and a connection point of the RF transmission cable to a first applicator. In some aspects, the RF-based treatment system can include a Y ranging from about 0 to about 2 inches. In some aspects, the RF-based treatment system can include a Y ranging from about 0 to about 6 inches. In various aspects, the RF-based treatment system can include a Y ranging from about 0 to about 24 inches. In some aspects, the RF-based treatment system can include a first control node comprising a first controller, wherein the first controller generates a control signal to measure a current in each of one or more electrodes in the electrode array.

[0042] In various aspects, the RF-based treatment system can include a foam material and a rigid support member, wherein the foam material is sandwiched between the rigid support member and the first support member. In various aspects, the RF-based treatment system can include a controller, where applicable, configured to provide an RF signal to the electrode array via the RF cable, the RF signal having a pulse duration that selectively heats membranes within the adipose tissue while substantially preventing heat conduction to adjacent tissue.

[0043] In various aspects, the RF-based treatment system can include an impedance tracker for monitoring the patient's tissue impedance during treatment and sensing changes in the patient's tissue impedance and relaying them to a controller so that the controller can terminate the RF signal in response to the occurrence of one or more events. In some aspects, the RF-based treatment system first support can be a rigid shell. In some aspects, the RF-based treatment system can include an array of K individually addressable electrodes that can be a first array, and also include a second array, wherein the first array can be arranged relative to a treatment area in a first zone. In various aspects, the RF-based treatment system can include the second array that can be arranged relative to a treatment area in a first zone, wherein the first zone and the second zone can be separate parts of the patient's body.

[0044] In various aspects, a method of controlling an RF-based processing system may include connecting a plurality of control nodes, wherein a first control node is a master control for the other nodes; synchronizing a second node and a third node with the first node, wherein the first, second, and third nodes are in electrical communication with a radio frequency (RF) transmission line; and transmitting a control signal from the first node to the second node using a serial communication protocol during an active processing period. In some aspects, the method may include an active processing period, which may include impedance mapping performed using an electrode array in communication with the RF transmission line. Optionally, in some aspects, the method may include phasing the second node using one or more output signals from the first node. In some aspects, the method may include measuring current signals at one or more electrodes using the third node. In various aspects, the method may include activating and deactivating electrodes using the third node. In many aspects, the method may include connecting the nodes using a plurality of connectors, wherein one of the connectors is the first node connected to a plurality of subnodes of the second node. In some aspects, the method may include wherein the active processing period also includes impedance mapping performed using the electrode array in communication with one or both of a second electrode array and a drain pad.

[0045] According to various aspects of the present teachings, a radio frequency (RF)-based treatment system includes: a flexible applicator, the flexible applicator including a plurality of layers, the plurality of layers including a first dielectric layer, a second dielectric layer, and a conductive layer, wherein the conductive layer is sandwiched between the first dielectric layer and the second dielectric layer, the plurality of layers defining a plurality of cuts; and an interior region and N regions extending from the interior region, wherein the plurality of cuts divide the applicator into the N regions.

[0046] In some aspects, N ranges from 2 to 12. Optionally, in some aspects, the plurality of layers define one or more strain relief elements, wherein each strain relief element is a circular or elliptical hole in the plurality of layers. Optionally, in some aspects, one or more of the plurality of cutouts terminate at one or more strain relief elements, wherein the interior region is adjacent to the one or more strain relief elements. Optionally, in some aspects, the interior region is a non-cutout region, wherein N is 6. Optionally, in some aspects, the plurality of N regions includes a first region and a second region, wherein each of the first region and the second region defines substantially the same one or more segments, boundaries, or cutouts.

[0047] In some aspects, the plurality of layers comprises a label, wherein the label comprises N region identifiers, wherein each of the N region identifiers is disposed on one of the N regions. Optionally, in some aspects, the applicator defines an applicator shape, wherein the applicator shape is selected from the group consisting of: elliptical, circular, substantially elliptical, substantially circular, pear-shaped, substantially pear-shaped, submental, and combinations thereof. Optionally, in some aspects, the conductive layer comprises a patterned area of ​​copper traces in each of the N regions, wherein each of the patterned areas has one or more copper traces in electrical communication with copper traces arranged along the interior region. Optionally, in some aspects, the applicator further comprises an electrical connector in electrical communication with one or more addressable regions of the conductive layer.

[0048] In some aspects, the system further comprises an RF processing system comprising an RF generator having an operating frequency in the range of about 0.5 MHz to about 10 MHz, wherein the RF generator is in electrical communication with the electrical connector. Optionally, in some aspects, the applicator further comprises an electrical connector in electrical communication with one or more addressable regions of the conductive layer, the electrical connector comprising a plurality of electrical contacts, wherein the copper traces arranged along the interior region are in electrical communication with the electrical contacts. Optionally, in some aspects, the copper traces arranged along the interior region are arranged in a series of three or more adjacent segments that increase in width in a direction toward the electrical connector. Optionally, in some aspects, the conductive layer comprises a continuous sheet of copper, and wherein each of the N regions further comprises: a first region of dielectric material having a first thickness and a first area; and a second region of dielectric material having a second thickness and a second area, wherein an area of ​​each region is greater than the first area disposed therein, and wherein each first area is greater than each second area.

[0049] In some aspects, the system further comprises an RF processing system comprising an interface device in communication with the RF processing system, the interface device comprising a clamp and a cable adapter, wherein the clamp opens and closes to releasably connect and align the electrical connector, wherein the cable adapter is in electrical communication with the electrical contacts of the clamp. Optionally, in some aspects, the area of ​​the electrode is in the range of about 50 cm 2 to about 600cm 2 Optionally, in some aspects, the system includes a thermal shield, wherein the conductive layer includes an arrangement of electrical traces, wherein the thermal shield covers a portion of the interior region, beneath which adjacent electrical traces span the portion and vary in density along the portion. Optionally, in some aspects, the system includes one or more temperature sensors per each of the N regions.

[0050] In some aspects, the system includes an RF treatment system in electrical communication with the applicator and each temperature sensor, and further includes a control system, wherein the control system selectively addresses each of the N regions according to one or more patterns to sequentially transmit RF energy to promote uniform heating. Alternatively, in some aspects, the system includes an RF treatment system in electrical communication with the applicator and each temperature sensor, and further includes a control system, wherein the control system selectively bypasses one or more of the N regions in response to an operator selecting that one or more of the N regions is positioned over a sensitive tissue area. Alternatively, in some aspects, the plurality of layers further includes one or more adhesive layers, a polyamide layer, and a hydrogel layer.

[0051] According to various aspects of the present teachings, a method for treating tissue using an RF-based applicator comprises providing a flexible applicator comprising an elongated inner spine region and a plurality of regions extending from the elongated inner spine region, wherein each of the plurality of regions is defined by a first incision and a second incision; and transmitting RF energy from each of the plurality of regions according to an alternating or sequential addressing scheme during an initial heating period to raise tissue beneath the applicator to a target temperature. Optionally, in some aspects, the method comprises shielding the inner spine region to avoid undesired heating of target tissue beneath the inner spine region of the applicator. Optionally, in some aspects, the method comprises controlling the transmission of RF energy such that one or more sensitive areas beneath one or more of the plurality of regions cannot be interrogated with the RF energy. In one embodiment, the method comprises controlling the transmission of RF energy such that one or more sensitive areas beneath one or more of the plurality of regions are cosmetically treated to enhance or induce lipolysis, skin tightening, and cellulite reduction. The method can be performed within a treatment time ranging from about 10 minutes to about 15 minutes.

[0052] Although the present 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 as part of separate components, devices, and systems, as appropriate. Thus, each embodiment disclosed herein can be incorporated into each aspect to varying degrees, as appropriate, for a given implementation. In addition, the various systems, probes, control nodes, applicators, controllers, components, and portions described above can be used with any suitable tissue surface, cosmetic and medical applications, and other methods, and can be combined with other devices and systems without limitation.

[0053] These and other features of the applicants' teachings are set forth herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Those skilled in the art will understand that the drawings described below are for illustration purposes only and are not intended to limit the scope of the applicant's teachings in any way.

[0055] Figure 1A Exemplary systems for providing RF treatment to various target areas of a patient's body in accordance with various aspects of the present teachings are schematically illustrated.

[0056] Figure 1B Schematically illustrates various aspects of the present teachings Figure 1A Additional exemplary aspects of the system.

[0057] Figure 1C An exemplary system for providing RF treatment to a target area of ​​a patient's body using an electrode tip in accordance with various aspects of the present teachings is schematically illustrated.

[0058] Figure 1D Another exemplary system for providing RF treatment to a target area of ​​a patient's body using an electrode array in accordance with aspects of the present teachings is schematically illustrated.

[0059] Figure 1E Another exemplary system for providing RF treatment to a target area of ​​a patient's body using two electrode arrays in accordance with aspects of the present teachings is schematically illustrated.

[0060] Figure 1F Another exemplary system for providing RF treatment to a target area of ​​a patient's body using one or more electrodes and a drain pad in accordance with aspects of the present teachings is schematically illustrated.

[0061] Figure 1GAn exemplary system for providing RF processing according to various aspects of the present teachings is schematically illustrated, including various nodes, such as control nodes, representing different connections and operational components of the system.

[0062] Figure 1H An exemplary arrangement of a control node suitable for use with RF-based system implementations according to various aspects of the present teachings is schematically illustrated.

[0063] Figure 1I An exemplary arrangement of nodes suitable for use with RF-based system implementations according to various aspects of the present teachings is schematically illustrated.

[0064] Figure 1J An exemplary arrangement of nodes suitable for use with RF-based system implementations according to various aspects of the present teachings is schematically illustrated.

[0065] Figure 1K An exemplary alternative arrangement of nodes suitable for use with RF-based system implementations according to various aspects of the present teachings is schematically illustrated.

[0066] Figure 2A An exemplary disposable system for providing RF treatment to a target area of ​​a patient's body in accordance with various aspects of the present teachings is schematically depicted.

[0067] Figure 2B -D schematically depicts various attachable electrode arrays having different shapes customized to cover various areas of a patient's skin for RF-based targeted treatment in accordance with various aspects of the present teachings.

[0068] Figure 2E -G schematically depicts various attachable electrode arrays having identical shapes customized to cover or surface various areas of a patient's skin for targeted RF-based treatment in accordance with various aspects of the present teachings.

[0069] Figure 2H Schematically depicted is a target tissue area that has been tiled or covered with multiple tissue-attachable electrode arrays having the same shape as part of a set or group of applicators in accordance with various aspects of the present teachings.

[0070] Figure 3A Exemplary systems for cooling a flexible electrode array and / or a patient's skin according to various aspects of the present teachings are schematically depicted.

[0071] Figure 3B-F schematically depicts various exemplary applicator embodiments suitable for treating tissue areas of various shapes in accordance with various aspects of the present teachings.

[0072] Figure 3G -H schematically depicts various exemplary applicator embodiments suitable for adhering to a tissue surface when placed in contact with the tissue surface according to various aspects of the present teachings.

[0073] Figure 3I -J schematically depicts various exemplary separable applicator embodiments including disposable and reusable components according to various aspects of the present teachings.

[0074] Figures 3K-3Q Various images depict exemplary detachable applicator embodiments according to various aspects of the present teachings.

[0075] Figure 3R -T schematically depicts various views of exemplary rigid applicator embodiments according to various aspects of the present teachings.

[0076] Figure 3U Depicted is an image of an electrode array facing embodiment of an exemplary rigid applicator according to various aspects of the present teachings.

[0077] Figure 4A Depicted are exemplary electrode arrays according to various aspects of the present teachings that can be individually addressed according to exemplary methods for monitoring and / or controlling the distribution of RF energy provided by the electrode array.

[0078] Figure 4B Schematically depicted are exemplary scans of a patient using one or more RF-based applicators to produce tissue assessment or other output of interest in accordance with various aspects of the present teachings.

[0079] Figure 4C Depicted is RF-based tissue treatment of a patient with respect to two sections of the patient in accordance with various aspects of the present teachings, wherein multiple tissue regions are treated in each such section using an RF applicator in contact with the patient.

[0080] Figure 4D RF-based tissue treatment of a patient is depicted with respect to two segments of the patient according to various aspects of the present teachings, wherein multiple tissue regions are treated using multiple applicators positioned relative to a support with respect to each such segment.

[0081] Figure 5A -F schematically depicts an exemplary process for targeting a membrane and an exemplary method for monitoring and / or controlling RF energy distribution according to various aspects of the present teachings.

[0082] Figure 6A Depicted are exemplary plots of tissue temperature of a target region including a fat region having a relatively uniform thickness during an exemplary treatment in accordance with various aspects of the present teachings.

[0083] Figure 6B Depicted are exemplary plots of tissue temperature of a target region including a fat region having relatively non-uniform thickness during an exemplary treatment in accordance with various aspects of the present teachings.

[0084] Figure 6C Schematically depicts the shift of the treatment zone due to the relatively non-uniform thickness of the fat region during RF treatment.

[0085] Figure 6D Depicted is an exemplary plot of tissue temperature due to treatment area shift during RF treatment of a fat region exhibiting relatively non-uniform thickness.

[0086] Figure 6E Depicted are exemplary plots of tissue temperature of a target region and correction for treatment zone shift during RF treatment of a fat region exhibiting relatively non-uniform thickness, in accordance with various aspects of the present teachings.

[0087] Figure 7A Depicted is a plot of RF power and temperature of a target area at a depth of 1.5 cm during an exemplary treatment in accordance with various aspects of the present teachings.

[0088] Figure 7B Depicted in Figure 7A Figure 2 is a plot of tissue impedance during an exemplary treatment using different cooling temperatures.

[0089] 7C1-8 depict exemplary electronics for an applicator having an electrode array according to various aspects of the present teachings.

[0090] Figure 8 is a schematic perspective view of a system for treating genitourinary disorders according to various aspects of the present teachings;

[0091] Figure 9 is a schematic perspective view of a probe and introducer according to various aspects of the present teachings.

[0092] Figure 10A is a schematic diagram of the female urogenital tract;

[0093] Figure 10B is a schematic diagram of the female urogenital tract showing insertion of a monitoring catheter into the urethra;

[0094] Figure 10Cis a schematic diagram of a female urogenital tract showing an inserted vaginal treatment probe according to various aspects of the present teachings;

[0095] Figure 11 is a schematic diagram of a probe operating in two different modes according to an exemplary aspect of the present teachings;

[0096] Figure 12 is a schematic diagram of an RF system including exemplary electronics according to various aspects of the present teachings;

[0097] Figure 13 An exemplary staged ablation treatment according to various aspects of the present teachings is depicted;

[0098] Figure 14A -C depicts the results of an exemplary staged ablation treatment at different pulse durations according to various aspects of the present teachings;

[0099] Figures 15A-15C Schematically depicts various exemplary flexible RF-based applicator embodiments suitable for treating tissue according to various aspects of the present teachings;

[0100] Figure 16 Schematically depicts an interface device suitable for quick connection and release of an applicator according to various aspects of the present teachings;

[0101] Figure 17 schematically depicts an embodiment of a flexible RF-based applicator according to various aspects of the present teachings, comprising in different regions different thicknesses of dielectric material suitable for treating tissue;

[0102] Figure 18 Schematically depicts various layers of an RF-based thin, flexible applicator embodiment according to various aspects of the present teachings;

[0103] Figure 19A schematically depicts an exploded view of various layers and components of an RF-based flexible applicator embodiment according to various aspects of the present teachings;

[0104] Figures 19B-19C Schematically depicts various aspects of the present teachings Figure 19A A top perspective view of an embodiment of a thin, flexible RF-based applicator;

[0105] Figure 20A schematically depicts a top view of an RF-based flexible applicator according to various aspects of the present teachings;

[0106] Figure 20B schematically depicts a bottom view of an RF-based flexible applicator according to various aspects of the present teachings;

[0107] Figure 20C schematically depicts a view of one side of an RF-based flexible applicator according to various aspects of the present teachings;

[0108] Figure 20D schematically depicts a view of the other side of an RF-based flexible applicator according to various aspects of the present teachings;

[0109] Figure 20E schematically depicts a rear view of a flexible RF-based applicator according to various aspects of the present teachings;

[0110] Figure 20F schematically depicts a front view of an RF-based flexible applicator according to various aspects of the present teachings;

[0111] Figures 21A-21F Schematically depicts various aspects of the present teachings Figures 20A-20F A view of the flexible applicator without the releasable liner;

[0112] Figures 22A-22B schematically depicts components of an RF-based flexible applicator according to various aspects of the present teachings, showing areas of electrical traces having one or more conductive layers;

[0113] Figures 23A-23B schematically depicting top and bottom views, respectively, of a flexible applicator prior to coupling with an interface device according to various aspects of the present teachings;

[0114] Figures 23C-23D schematically depicting an interface device in open and closed configurations according to various aspects of the present teachings;

[0115] Figure 24A schematically depicts a top view of an interface device according to various aspects of the present teachings;

[0116] Figure 24B schematically depicts a top side view of one side of an interface device according to various aspects of the present teachings;

[0117] Figure 24C schematically depicts a bottom view of an interface device according to various aspects of the present teachings;

[0118] Figure 24D schematically depicts a top view of another side of an interface device according to various aspects of the present teachings;

[0119] Figure 24E schematically depicts a front view of an interface device according to various aspects of the present teachings;

[0120] Figure 24Fschematically depicts a rear view of an interface device according to various aspects of the present teachings;

[0121] Figures 25A-25C Schematically depicts various dispensing arrangements suitable for use with RF-based flexible applicators and other applicators disclosed herein in accordance with various aspects of the present teachings;

[0122] Figure 26A schematically depicts a top view of a flexible RF-based applicator for submental treatment according to various aspects of the present teachings;

[0123] Figure 26B schematically depicts a bottom view of a flexible RF-based applicator for submental treatment according to various aspects of the present teachings;

[0124] Figure 26C schematically depicts a view of one side of a flexible RF-based applicator for submental treatment according to various aspects of the present teachings;

[0125] Figure 26D schematically depicts a view of the other side of an RF-based flexible applicator according to various aspects of the present teachings;

[0126] Figure 26E schematically depicts a rear view of a flexible RF-based applicator according to various aspects of the present teachings;

[0127] Figure 26F schematically depicts a front view of an RF-based flexible applicator according to various aspects of the present teachings;

[0128] Figure 27A schematically depicts an exploded view of various layers and components of an embodiment of a flexible RF-based applicator for treating the submental area according to various aspects of the present teachings;

[0129] Figures 27B-27C Schematically depicts various aspects of the present teachings Figure 27A a top perspective view of an embodiment of an RF-based flexible applicator; and

[0130] Figure 28A and 28B Depicted are graphical user interfaces (GUIs) for use with a processing system using an applicator according to various aspects of the present teachings, showing different configurations. DETAILED DESCRIPTION

[0131] It should be understood that, for the sake of clarity, the following discussion will illustrate various aspects of the embodiments 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 embodiments may be simplified. For the sake of brevity, well-known ideas or concepts may not be discussed in detail. Those skilled in the art will recognize that some embodiments of the applicant's teachings may not require certain specifically described details in each implementation, and these details are set forth herein only to facilitate a thorough understanding of the embodiments. Similarly, it will be apparent that the described embodiments can be easily changed or varied according to common general knowledge without departing from the scope of this disclosure. The following detailed description of the embodiments should not be construed as limiting the scope of the applicant's teachings in any way.

[0132] As used herein, the terms "about" and "substantially the same" refer to variations in numerical quantities that may occur, for example, through real-world measurement or processing procedures; through unintentional errors in these procedures; through differences / failures in the manufacture of electrical components; through power losses; and variations that a person skilled in the art would consider equivalent, as long as such variations do not include known values ​​practiced by the prior art. Generally, the term "about" refers to a value or range of values ​​that is greater than or less than 1 / 10 of the specified value, for example, ±10%. For example, applying a voltage of approximately +3V DC to an element may represent a voltage between +2.7V DC and +3.3V DC. Similarly, where values ​​are referred to as "substantially the same," the values ​​may differ by up to 5%. Whether or not modified by the terms "about" or "substantially" the same, the numerical values ​​recited in the claims include equivalents of the recited values, for example, variations in the numerical quantities of such values ​​that may occur but would be considered equivalent by a person skilled in the art.

[0133] As discussed in detail below, systems and methods are provided for treating a patient's skin (e.g., dermis and hypodermis), the surface of a patient's mucosal tissue (e.g., the surface of vaginal tissue or the surface of esophageal tissue), or other target tissue (including tissue located at a depth below the tissue surface (e.g., the surface of the skin, the mucosal surface of the vagina, or the esophagus)) using RF energy, and the systems and methods can generally include: one or more RF energy sources (e.g., RF generators); a treatment applicator comprising one or more electrode arrays configured to be placed in contact with the tissue surface; and a return electrode (e.g., a neutral pad) coupled to the tissue surface. The electrodes can include zones or regions of the applicator comprising multiple electrical traces or patterned / gradient containing regions of materials having different dielectric constants / properties, as well as other combinations and configurations of electrical components as disclosed herein. The systems and methods disclosed herein for delivering RF energy to one or more target areas can be used, but are not limited to, in one or more lumens or cavities of a patient.

[0134] In general, the methods and systems disclosed herein can be used to provide various non-medical treatments, such as cosmetic treatments, cosmetic treatments, and combinations thereof. Skin tightening, such as by improving skin laxity, and body contouring (e.g., via thermotherapy and via lipolysis) are examples of cosmetic and / or cosmetic treatments that can be achieved using various RF-based systems and methods, such as those discussed in more detail below.

[0135] In various aspects, the systems and methods can treat unwanted fat (e.g., via lipolysis), improve skin laxity / firmness (e.g., by stimulating collagen), improve the appearance of cellulite (e.g., by rupturing the septum), and treat various genitourinary conditions by administering RF energy (e.g., about 500 kHz, about 0.5 MHz, about 1 MHz, less than about 1 MHz, greater than about 1 MHz, about 1.5 MHz, about 2 MHz, about 2.5 MHz, about 3 MHz, about 3.5 MHz, about 4 MHz, about 4.5 MHz, and 5.5 MHz, or other frequencies including frequencies ranging from about 0.5 MHz to about 10 MHz) delivered to a patient's tissue surface (e.g., skin, vaginal wall, esophagus) via a treatment electrode or electrode array, which is optionally water-cooled, and the RF energy propagates from the surface into deeper tissue layers and returns to the RF generator via a return electrode (e.g., a large surface area neutral pad) coupled to the tissue surface at a location distal to the treatment electrode or electrode array. According to various aspects of the present teachings, there is provided a method for heating a relatively large area (e.g., greater than about 24 cm) using RF energy by applying (e.g., placing, securing) an applicator to the skin, energizing the device (e.g., activating an RF generator), while cooling the superficial layers, and selectively controlling the deposition of RF energy to heat the tissue beneath the surface. 2 , greater than about 50cm 2 or greater than about 200cm 2 Systems and methods for treating target tissues of a specific region of interest. According to various aspects of the present teachings, deposition of RF energy and / or cooling of tissue can be provided such that the tissue beneath the surface is substantially uniformly heated. It will be appreciated from the present teachings that heating uniformity may be desirable to help provide safety, patient tolerance, and consistent clinical outcomes.

[0136] Now refer to Figure 1A and 1B , schematically depicts an exemplary system 100 according to various aspects of the present teachings. As shown, the system 100 generally includes a console 110 and one or more applicators 130a-d, the applicators comprising: one or more conductive electrodes (e.g., composed of metal) configured to be placed in electrical contact with a patient's tissue (e.g., adjacent an area to be treated) for applying RF energy to the tissue surface; and a return electrode (e.g., a neutral / drain pad 130e, as shown in FIG. Figure 1A As shown, or active electrode array 160, as Figure 1B130a-d and an additional port for electrical connection to the drain pad return 130e. As discussed in detail below, for example, the applicators 130a - d may each include cooling water attachments and electrical connections to support serial communications between the console 110 and the applicators 130a - d , each connected to the console 110 via its own cable or umbilical 133 .

[0137] As this article about Figure 1G As discussed in more detail, the length of the umbilical cable may also be referred to as the length X. Each range described herein may be applicable to Figure 1G Length X between control node 1 and node 2 is shown. In one embodiment, the length of the umbilical cable can range from about 10 feet to about 20 feet. In one embodiment, the length of the umbilical cable can range from about 1 foot to about 10 feet. In one embodiment, the length of the umbilical cable can range from about 2 feet to about 8 feet. In one embodiment, the length of the umbilical cable can range from about 20 feet to about 50 feet. In one embodiment, the length of the umbilical cable is greater than about 20 feet.

[0138] One or more RF generators 135, 136 are generally configured to generate energy that is delivered to applicators 130a-d via one or more transmission lines extending through the umbilical cable 133 for application to tissue (e.g., as modified by distributed electronics within the applicators 130a-d), and the generators can be any known or later developed RF energy source modified in accordance with the present teachings. Exemplary commercially available RF sources suitable for modification in accordance with the present teachings include the ForceTriad® sold by Covidien. TM Energy Platform. In some aspects, a plurality of RF energy generators can be provided, wherein each energy generator is configured to generate RF energy having characteristics different from each other, such that one or more generators can be used individually or in combination depending on the desired treatment. Figure 1AAs shown, as a non-limiting example, system 100 includes two generators, one generator labeled 135 that can generate RF energy with a maximum power of 300W at 1 MHz (and can operate at a 100% duty cycle), and another generator labeled 136 that can generate RF energy with a maximum power of 1 kW at 1 MHz (and can operate at a 20% duty cycle).

[0139] Those skilled in the art will appreciate from the present teachings that various parameters of the RF energy (maximum power, frequency, duty cycle, pulse duration, etc.) can be selected based on the desired treatment and treatment area, as discussed elsewhere herein. For example, it should be understood that one or more of the plurality of RF generators 135, 136 can be adjusted to provide various powers, including, for example, to an applicator (e.g., Figure 1B 130a) and a return electrode per applicator (e.g., Figure 1B 130b) of 300W RF energy, the return electrode is configured to have an area of ​​about 200cm 2 (about 100cm 2 x 2) or about 1.5W / cm 2 , wherein each applicator 130a and 130b provides about 1.5W / cm 2 .

[0140] Other suitable RF energy generators may be employed, as discussed elsewhere herein, for example, by way of non-limiting example, a suitable RF energy generator may provide approximately 0.5 W / cm 2 to about 5W / cm 2wattage range. In various aspects, the appropriate duty cycle can vary depending on the target tissue type, however, in some exemplary tissue heating applications, the goal may be to deliver a certain amount of RF energy in order to cause a temperature increase while keeping the treatment time as short as possible. Therefore, as the duty cycle is reduced, the RF energy can be increased to compensate for the reduced amount of "on time" so as not to extend the total treatment time. Exemplary duty cycles for heating skin and fat are about 30% to about 80%, for example, an RF duty cycle of about 50% will be on for 5 seconds and then off for 5 seconds. The duty cycle can be adjusted at different frequencies ranging from microseconds to seconds, because in some applications, faster adjustment cycles can achieve more precise control, while in other applications, longer adjustment cycles may be desired. The duty cycle can also be adjusted to optimize energy deposition in different tissue layers or types: anatomical regions with large, deep, and highly perfused tissue target areas (e.g., fat) can allow for relatively long duty cycles (e.g., 80% duty cycle instead of 30% duty cycle), while shallow, small, and poorly perfused tissue (e.g., skin) may require relatively short duty cycles (e.g., 30% duty cycle is better than 80% duty cycle). Applications other than bulk heating that rely on tissue impedance to select target tissue can greatly benefit from very short duty cycles, even duty cycles of <1%. Such short duty cycles can also be characterized or referred to as pulsed RF.

[0141] like Figure 1A and Figure 1B As shown, the exemplary system 100 can include multiple applicators 130a-d, representing a widely adaptable independent system for safely and effectively heating and / or cooling tissue. In various aspects, reducing and or maintaining the temperature of the patient's skin tissue surface - for example, by flowing water near a relatively rigid applicator (e.g., applicators 130a and 130b) or a flexible applicator (e.g., applicator 130c applied to the skin via an adhesive) - can be important for maintaining patient safety and comfort. As shown, each of the applicators 130a-c can include a relatively rigid or flexible applicator body, distributed electronics, a water bladder or reservoir, an electrode array, and an adhesive for helping to secure the applicator 130a-c to the patient's skin, all of which are non-limiting examples. In some additional or alternative aspects, a vacuum can be used to help secure the applicator to the skin. As discussed in detail below, the applicators 130a-c can have various configurations, but are generally configured to couple to a patient's tissue surface such that RF energy delivered to the applicators 130a-c can be applied to the patient's tissue via one or more electrodes disposed in contact with the tissue surface. The applicators 130a-c can also have various configurations. Additional exemplary applicator configurations are described in greater detail herein.

[0142] For example, in Figure 1A and 1B In the exemplary system 100 of FIG. 1 , the applicators 130a-b can be substantially identical to one another, with one electrode array serving as the treatment electrode array and the other electrode array serving as the return electrode to complete the circuit. In various aspects, the system 100 can operate in a monopolar mode such that the circuit consists of electrodes from one applicator (e.g., Figure 1B 130a) of the electrode array 160a of the source electrode 162a and from another applicator (e.g., Figure 1B Additionally or alternatively, in some aspects, a large area drain pad 130e (also referred to herein as a "return electrode") can be attached to the tissue surface at a location remote from the treatment applicators 130a-d to distribute and / or return RF energy applied to the patient tissue from one or more of the "active" applicators 130a-d, such as Figure 1A As best shown. As discussed elsewhere herein, when tissue reaches the clinical endpoint for certain electrode arrays, other arrays may not deliver the full dose due to anatomical differences. In such cases, power consumption to the auxiliary return electrode 130e can be used to increase the relative temperature of the lag position. In some alternative aspects, bipolar operation can be achieved by activating electrodes within a single applicator array (e.g., array 160a of applicator 130a).

[0143] like Figure 1A As shown and as discussed elsewhere herein, the applicator 130c can also include an electrode array and can be relatively rigid, but have a shape configured to fit a particular body region. By way of non-limiting example, the applicator 130c can provide an electrode array disposed within a recess that can be configured to receive a submental region of a patient such that when coupled to the submental region of the patient, contact is substantially maintained between the skin surface and the electrode surface. Alternatively, the applicator 130c can be relatively flexible such that it can conform to curved tissue surfaces (e.g., the submental region, jaw, neck, and abdomen). Figure 1A As shown and as discussed elsewhere herein, an applicator handpiece 130d having one or more electrodes can be provided that is capable of operating in a stamping mode. For example, the applicator 130d can be held against the tissue surface of a particular treatment area while one or more RF pulses are applied to the tissue surface. In some aspects, the applicator 130d can be configured to provide: one or more short durations; high power RF pulses, which can utilize one or more of impedance mapping, impedance tracking, and temperature monitoring, as discussed elsewhere herein. After treating a particular area, the handpiece applicator 130d can be moved to another location. It should also be understood from the present teachings that more than two applicators can be used to cover a larger area.

[0144] Now refer to Figures 1C-1F Other exemplary applicator electrodes will now be described with reference to an electrosurgical unit (ESU) system 100 having a console 110 as known in the art and modified in accordance with the present teachings. Figure 1C As shown, for example, the ESU 100 can be configured to focus RF power and subsequent tissue heating on the electrode tip 162d (e.g., comprising a single small-area electrode) of the applicator 130d (e.g., configured to be held against the patient's tissue surface and operated in a stamping mode), while the relatively large-area drain pad 130e (e.g., the return electrode has a surface area that can be up to about 5000 times the surface area of ​​the delivery tip). In this way, due to the proper distribution and / or allocation of the RF power, non-uniformities in the return path remain sufficiently safe to avoid burns.

[0145] Now refer to Figure 1D In some alternative aspects, the ESU 100 can instead include an applicator 130a having an electrode array 160a (e.g., including a plurality of individually addressable electrodes 162a) for evenly distributing power over a large area, with the drain pad 130e representing a return path. Figure 1C In that way, the surface area of ​​the return electrode 130e relative to the treatment electrode array 160a can help ensure that the RF energy is adequately distributed to avoid undesirable damage. Figure 1C The return pad 130e shown is different. Figure 1D The return pad 130e in FIG. 1 is similar in surface area to the electrode array 130a, so that the benefits of large-area uniformity in the return pad 130e are reduced. That is, a return pad having a larger surface area than the electrode array can generally help avoid undesirable side effects (e.g., hot spots) in the return pad. For large-area treatment targets with an electrode array, such as Figure 1D As shown, the size requirements of the return pad may be impractical and impossible to size for connection to an untreated portion of the body (eg, too large to connect to an untreated portion of the body).

[0146] In addition, as discussed in detail below, various mechanisms according to the present teachings can be utilized to reduce "hot spots" on active treatment electrodes and ensure more uniform treatment. For example, as discussed in detail below, the distribution electronics of the applicator 130a can be used to provide the same or different RF signals to the various electrodes 162a of the electrode array 160a to provide improved control of the treatment program.

[0147] like Figure 1EAs shown, in some aspects, the system 100 can instead utilize two electrode arrays disposed on different applicators: a first applicator 130a having a delivery treatment electrode array 160a; and a second applicator 130b having a return electrode array 160b that is also used to deliver treatment energy via the electrode arrays. In these aspects, the return electrode array 160b can mirror the treatment electrode array 160a, thereby also providing treatment energy, and can help achieve good uniformity in both skin contact areas contacted by the first applicator 130a and the second applicator 130b. In some aspects, the size of both treatment pads is approximately 100 cm 2 , and each can deliver RF energy to provide uniform deep heating, whereas if differential heating occurs (e.g., due to perfusion, as described above with respect to Figure 1A If two treatment locations are in contact with the first applicator 130a and the second applicator 130b, the third electrode can consume power from that location. RF energy, current, signal or energy 159a can flow between the applicators / electrodes as shown.

[0148] like Figure 1F As shown, in some aspects, the system 100 can also utilize an applicator 130j having an electrode array 160a and another applicator 130k having electrodes 160b for use with a drain pad 130e or other drain device. The applicators 130j, 130k can be attached via an umbilical cable 133. The applicators 130j, 130k and the drain pad 130e can be used during the active treatment period to perform impedance mapping using an electrode array (130k or 130j) in communication with one or both of the second electrode array (130j or 130k) and the drain pad 130e. As shown, RF energy, current, signal, or energy 159b can flow between the applicator 130k and the drain pad 130e.

[0149] Optionally, in some exemplary aspects, the applicators 130a-d can include one or more coupling features (e.g., clips) that allow the applicators to be clipped into a frame that is attached to a strap or the like that surrounds the frame (and the applicators attached thereto) or attaches the frame (and the applicators attached thereto) to a patient's surface, so as to provide the clinician with a hands-free connection of the device to the patient. In another embodiment, the applicators 130a-d can be attached directly to the skin surface via, for example, an adhesive, a gel, and / or mild suction.

[0150] Although according to the embodiments disclosed herein, Figure 1DThe applicator of the invention is generally shown as including a generally planar electrode array (e.g., a rigid or flexible electrode array) or a single electrode, but in some alternative aspects, the applicator can be configured for insertion into an internal tissue site to apply RF energy to a mucosal tissue surface or to a depth below a mucosal tissue surface (e.g., vaginal wall, esophageal lining). For example, as described below with reference to Figure 8-12 As discussed in detail, the applicator may include a generally tubular probe that is sized and shaped to be inserted into the vagina or esophagus for RF treatment thereof. One skilled in the art will appreciate from the discussion herein that the probe may include a plurality of electrodes (or groups of electrodes) that may be activated to apply RF energy to the target tissue in a monopolar mode, a bipolar mode, or a hybrid mode. Figures 15A-15C Additional examples of applicators suitable for applying and directing RF energy are depicted in , 17, 19A-21F, 22A, 22B, 23A, 23B, 25A-25C, 26A-26F, and 27A-27C.

[0151] Operation Mode

[0152] The teachings herein include various electrical configurations, i.e., monopole, bipole, and a mixture thereof. The monopole configuration includes an active electrode (or electrode array) and a passive electrode (e.g., a drain pad). The bipole configuration includes two separate active electrodes (or two separate active electrode arrays). The hybrid configuration includes two separate active electrodes (or two separate active electrode arrays) and a passive electrode (e.g., a drain pad). Figure 1C and 1D The exemplary electrical configuration shown in is unipolar, while Figure 1E The electrical configuration shown in is bipolar. Figure 1A The electrode configuration shown in FIG1 is a hybrid. It should be understood that where only the pulse handpiece 130d and drain pad 130e as shown in FIG1 are used, this configuration would be monopolar. On the other hand, using and activating only the electrodes of the electrode arrays on both applicators 130a and 130b would be a bipolar configuration. Figure 1A Yet another subset of the options shown in , using two applicators 130a, 130b and a drain pad 130e, would be a hybrid configuration.

[0153] Figure 1Gis a schematic diagram illustrating a representation of an RF-based tissue treatment system 170A according to the present disclosure, wherein various operational and / or connectivity control nodes are shown. Specifically, Node 0, Node 1, Node 2, and Node 3 are shown in sequence. As an introduction to the specific roles of a given node type, in some embodiments, Node 0 can serve as a master control node. Node 1 can control and direct the transmission of various DC power signals and other signals discussed in more detail herein. Additionally, Node 2 can control the individual activation and deactivation of electrodes and other functions described herein. Node 3 is used to designate an electrode array that receives one or more signals, power, and other parameters from one or more nodes to which it is connected. Nodes can be interchangeably referred to as control nodes or nodes. In one embodiment, the nodes have a hierarchical architecture in which Node 0 sends control signals and related signals to other nodes to control their operation. Nodes can be considered to be reference points or labels corresponding to various electronic components or other components or subassemblies of a given RF-based tissue treatment embodiment. Temperature measurements can be taken using a sensor in an applicator located near Node 3. Specifically, in one embodiment, temperature measurement is performed using signals from such sensors, and a temperature measurement value is obtained at node 1 or node 2 .

[0154] Additionally, each of these nodes (Node 0 - Node 3) can also be used as a category or grouping, so that each of these four nodes has other nodes grouped with it. For example, in Figure 1H , node 0 can have multiple other node 0s. As shown, node 0 can have nodes 0 to n, where node k is marked as an example node. In turn, node k, which is a node 0 level node, communicates with several node 1 type nodes marked 1.1, 1.2, 1.3-1.n. In various embodiments, a group of nodes (node ​​0, node 1, node 2, and node 3) within one of the higher level node categories can be referred to as child nodes. n is used as an index to identify the number of nodes of a particular node type. The cardinality of the set of nodes of node 0 type is n. In some embodiments, the number of nodes of each node type can be greater than or less than n. For example, there can be one node 0 and twenty nodes of type node 1, 2, or 3. In general, the number of nodes of each node type can be any positive integer greater than or equal to 1.

[0155] Reference Figure 1G, each node may have nodes located within or connected to another node. Starting with node 0, the node corresponds to the RF driver platform of a given RF processing system embodiment. Node 2 is responsible for turning on / off the individual electrodes in the applicator and making local measurements of the individual currents flowing out of each individual electrode. The RF driver platform (node ​​0) includes one or more components that provide individual commands to other nodes or sub-nodes. The RF driver platform (node ​​0) can be implemented using one or more logic devices, FPGAs, circuits, circuit elements, or a combination thereof. One or more electrical connectors 171 can be used to connect the nodes, and the one or more electrical connectors can include one or more cables, buses, or other electrical signal connection and transmission mechanisms.

[0156] Node 0 includes one or more devices that act as a master controller or "brain" to regulate and control in a consistent manner all such drivers, controls, signals, parameters, including the phase, frequency, period, and amplitude of drive or control signals directed to other nodes and sub-nodes connected to Node 0. Thus, if Node 0 specifies a specific phase and amplitude for a signal that will drive a set of electrodes of an array of addressable electrodes at a Node 3-type node, these outputs and other signals can be timed and controlled, in whole or in part, by Node 0.

[0157] Still refer to Figure 1G In one embodiment, node 0 may include one or more control or timing components 173. The control or timing component 173 may include a system clock, a clock generator, or other device for timing and synchronizing the nodes to which node 0 is connected, such as node 1, node 2, and node 3. The control or timing component 173 may include one or more of a controller, a feedback loop, a waveform generator, and one or more filters. Node 0 may include or be connected to a DC power supply, an AC power supply, a connector connected thereto, or a combination thereof. The RF driver platform (node ​​0) may include a main logic device disposed in a system component, such as console 110 or other consoles described herein. A coolant flow path 172 extending from node 0 is also shown as consistent with an embodiment having node 0 within console 110. In general, with respect to the electrical connections shown in solid lines between node 0, node 1, and node 2, the coolant flow path 172, also shown in dashed lines, may originate from any node or connect to an applicator from a different source.

[0158] Node 0 controls the timing of all other nodes in the system (such as node 1, node 2, and node 3) and sub-nodes within each of these node types or categories. This can be performed using one or more timing components 173. Thus, node 0 can facilitate serial communication with other downstream nodes (such as type 1, type 2, and type 3 nodes) via active RF processing lines. In turn, this node configuration, alone or in conjunction with the use of serial communication signals, facilitates phase control of various nodes and sub-nodes in electrical communication with node 0. In one embodiment, the system drives the serial communication length synchronously with the base RF frequency. Given that the phase angles of various waveforms may vary over time, the timing control provided by node 0 and the timing components supports specifying a given phase on a signal-by-signal basis. In turn, this facilitates phase tuning or adjustment of each addressable electrode (such as those shown in node 3). In addition, this implementation of timing and phase control using node 0 supports any phasing scenario with respect to node 1 and other nodes.

[0159] The RF-based processing systems described and depicted herein (including those related to Figure 1H Node 0 and any of its child nodes are designed to phase Node 1 and any of its child nodes. Node 0 can output one or more signals with a set phase or phase relationship. In one embodiment, Node 1 is located in, near, or around an RF generator.

[0160] In various embodiments, node 1 controls one or more (or all) of the DC voltage, the RF drive signal, and the relative phasing of the RF drive signal. Furthermore, in various embodiments, node 1 specifies the frequency and pulse form (sine wave, triangle wave, square wave, chirp, sawtooth wave, etc.) of the RF drive signal, as well as other signal parameters.

[0161] There may be multiple of any of these nodes in a generator (e.g., one per applicator, multiple nodes per applicator, or multiple applicators per node). These node1 nodes (or child nodes) are labeled 1.1, 1.2, 1.3...1.n, etc., as Figure 1H -K. As with Node 0 and the other nodes described and depicted herein, Node 1 can be used as a category or node type for all nodes that are part of an RF generator or perform an operation or function of an RF generator. The use of subnodes is simply to convey the idea that a subnode is a type of node, but each subnode is itself a node that can be connected to other nodes. The node hierarchy is unlimited, and any given node for a specific function, electrode connection, applicator connection, etc. can define another node category to group nodes with similar functions and / or connections together. Thus, a node can be, but is not limited to, mapping to one or more applicators and vice versa.

[0162] As noted herein, Node 0 can facilitate serial communication with other control nodes or other components to which it is connected via active RF processing lines. Additionally, differential serial communication between Node 1 and Node 2 can be implemented using twisted pair conductors, such as Figure 1J 1 and 2. Node-based system 170C is shown in FIG. 1 . As shown, exemplary node 1.1 of node 1 is connected to node 2 via one or more twisted pair conductors. In turn, each node 2 is connected to one of nodes 3 as shown. A limited number of twisted pairs (e.g., 1 to 20 twisted pairs) delivering RF power and control signals to the distributed electronics (node ​​2) allows for no practical limit on the length of the electrical connection 171 between nodes 1 and 2, and the twist shape improves noise immunity, thereby reducing the likelihood of contaminating the integrity of the control signals.

[0163] Furthermore, placing the distributed electronics (node ​​2) away from the platform (node ​​0) and closer to the applicator's electrodes (node ​​3) can improve the fidelity of controlling and reading individual electrodes. Long lead lengths from the distributed electronics to the individual electrodes can obscure control of the individual electrodes by promoting crosstalk between the individual channels and degrading the performance of the architecture's mapping and processing capabilities. In this way, controlling the length of the lead wires can improve mapping and processing performance.

[0164] In various embodiments, node 1 has one or more outputs. This can be Figure 1I The outputs of Node 1 include: one or more main RF drive signals that power the electrodes for processing; communication signals or data between Node 1 and Node 2; and a DC power source that powers Node 2. In one embodiment, Node 1 provides isolation / electrical safety to the patient to prevent any hazardous electrical current from reaching the patient. In one embodiment, Node 1 is configured to prevent the transmission of any harmful alternating current. In one embodiment, Figure 1I The node connections shown in are configured for a typical processing scheme using RF energy.

[0165] Each individual Node 1 child node (1.1, 1.2, 1.3, ... 1.m) can be individually phased so that one or more or all output signals from Node 1 are arranged to have all of the following: the same phase, different phases, or grouping of phases between subsets of nodes before transmitting such signals to Node 2. Figure 1I As shown, each node of type Node 1—nodes 1.1, 1.2, 1.3, 1.4, ... 1.m—is connected to a node of type Node 2 in a 1-to-1 fashion. In turn, each node in the Node 2 node group (nodes 1.1.1 ... 1.n.1) branches into multiple nodes of type Node 3.

[0166] Specifically, if Figure 1I As shown, each node in the Node 2 group is connected or mapped to n nodes in the Node 3 group. Thus, the node configuration 170B has each Node 0 connected to n nodes at Node 1, where each of the n nodes at Node 1 is connected to a single node at Node 2, and then ultimately all n nodes at Node 2 are each connected to n nodes at Node 3. This hierarchical mapping of the network topology takes the form 1 to all n, each n to one n, and each n to all n moving from left to right from Node 0 to Node 3.

[0167] Node 2 is responsible for turning on / off the individual electrodes in the applicator. In one embodiment, Node 2 is also responsible for making local measurements of the individual currents flowing out of each individual electrode. Figure 1I compared to, Figure 1K An alternative configuration of node 170D is shown, where each Node 0 is connected to n nodes of type Node 1. In turn, all n Node 1 nodes are connected to a single node at Node 2, as shown by Node 1.1.1. The only Node 2 node, Node 1.1.1, is connected to all n nodes at Node 3. This configuration is a 1 to all n, all n to only 1 n, and only 1 n to all n.

[0168] based on Figure 1K In the node connection arrangement of the node-based control system 170D in FIG, such local measurements cannot be performed at Node 1, but rather are measured at Node 2. This is because Node 2 enables each node at the Node 2 level to be connected to a group of electrode groups in the applicator, such that all Node 2 nodes interface with all electrode nodes (Node 3) at the applicator. The ability of the Node 2 nodes to measure individual currents facilitates impedance mapping and individual addressing of electrodes in the electrode array.

[0169] Logic elements (such as FPGAs, ASICs, circuits, and combinations thereof) are selected and arranged so that Node 1 can individually set all phase values ​​for signals output from Node 1 to other nodes (such as Node 2 and Node 3) and each of their child nodes. This is advantageous because it broadens the range of processing options and RF profiles that can be implemented at the electrode array of Node 3. Specifically, Node 1 can be selectively phased in different configurations based on the selected node, the phase of each node, and the timing of initiating phasing or starting waveform propagation from or to each node.

[0170] Various configurations are possible for phasing node 1. These may include, but are not limited to, the following exemplary phasing sequence:

[0171] All nodes are phased in one phase as follows: 1.1, 1.2, 1.3, ... 1.n.

[0172] • Individually phase the nodes as follows: Phase node 1.1 followed by phase node 1.7 followed by phase node 1.2 followed by phase node 1.16 followed by phase node 1.1 followed by phase node 1.2 followed by phase node 1.3 followed by phase node 1.n.

[0173] • Node phasing in the cluster as follows: Phase nodes 1.1-1.6 followed by phase nodes 1.7-1.12 followed by phase nodes 1.13-1.18 followed by phase nodes 1.1-1.6 etc.

[0174] The foregoing is merely exemplary, and any combination or all of the child nodes of Node 1 or a subset thereof may be phased in a cluster, individually, collectively, in different phasing sequences or orders, or a combination thereof. This flexibility of phasing all together, individually, in a cluster, etc., enables one to tailor the treatment to the contours of the patient tissue being treated and to the location of the user. Generally speaking, although the exemplary control nodes are labeled or referred to as Node 0, Node 1, Node 2, and Node 3, each of the foregoing may be referred to, without limitation, as the first node, the second node, the third node, or the fourth node.

[0175] Cables / Umbilicals

[0176] As this article about Figure 1A As described, various conformable, rigid, semi-rigid, hybrid, disposable, reusable, partially reusable applicators and other applicators of RF energy described herein are connected to a console, such as console 110. Electrical connections from a given console embodiment to the applicators, as well as one or more of the various control node electrical connections, can be routed through an umbilical housing to safely protect the signal transmission conductors. In one embodiment, one or more sections of such an umbilical can house the RF transmission cable, its sections, and the tubing or flow path for circulating coolant to a given applicator.

[0177] In one embodiment, the length of the RF transmission cable, or the length of the conductor segments between sections thereof or various control nodes, or a subset or combination of the foregoing lengths, should be selected to support the operation of the RF-based systems described herein. In one embodiment, the present disclosure relates to various operating lengths for various electrical conductor lengths used in the systems to support the operation thereof. In some embodiments, if these lengths are exceeded, excessive noise, crosstalk, or other deleterious effects may prevent the RF-based processing systems disclosed herein from operating, or may prevent the RF-based processing systems from operating with the desired efficiency and effectiveness. By reference to Figure 1G You can see some examples of these length parameters.

[0178] like Figure 1G As shown, the distance between Node 1 and Node 2 is identified as length X. This length X may correspond to the length of the umbilical cable from a given console embodiment. Figure 1A Various suitable X length distances are discussed. In addition, the distance between node 2 and node 3 is identified as length Y. Length Y can include the length of one or more conductors (such as the multiple conductors used in RF transmission cables). Length Y can be less than the flow path of the coolant from node 2 through the applicator. Length Y can be measured from the output of node 2 to the input of the applicator. In addition, length Y can include traces or wires that extend into the applicator and terminate at a given electrode. Length Y can also include the average distance between various conductors within the applicator and each electrode, and the length of such conductors between the entry point of such conductors into the applicator plus the output of node 2 and the input of node 3. The input of node 3 can include an opening or channel for the conductors from node 2 to enter the applicator. In general, the distance or length Y is the distance outside node 2 from the output of node 2 to the starting point of the applicator.

[0179] In order for the entire system to work well at all required capacities, the selection of the length or distance Y is important to the successful operation of a given applicator-based RF treatment system. The selection of length Y maintains the electrode activation and deactivation functionality of node 2 and the current measurement functionality of node 2, so it facilitates impedance mapping and other derived functions. As part of the design work and node-based conductor configuration, it has been determined that in one embodiment, Y ranges from about 0 inches to about 2 inches. This specification of the Y distance supports a system configuration that avoids wires or other conductors and uses printed circuit boards with conductive traces to improve impedance mapping and reduce cross-coupling below a threshold level. In one embodiment, the range of about 0 to about 2 inches includes traces on the PCB. In another embodiment, the range of distance Y is about 0 to about 6 inches. In yet another embodiment, the range of distance Y is about 0 to about 1 foot. Alternatively, the range of distance Y can be about 1 foot to 2 feet. In other embodiments, Y is less than about 3 feet.

[0180] With the foregoing discussion of exemplary systems and descriptions of various electrode configurations and arrangements, it is helpful to consider additional details related to various processing parameters and other features of the present disclosure. Those skilled in the art will understand from this teaching that exemplary systems can provide the following benefits and / or include some or all of the following features:

[0181] Treatment temperature and cooling of the patient's skin

[0182] In various aspects, it can be important to ensure uniformity in the delivered RF energy in order to safely elevate the target tissue to the desired temperature. In particular, to provide effective treatment, it may be important to elevate the target tissue to the desired temperature range, but also to maintain the tissue in the target area at this elevated target temperature for a given duration. In other words, "time at temperature" may be important in conferring the desired clinical benefit. For example, the temperature within the fat layer may range from approximately 39°C to approximately 47°C, or from approximately 39°C to approximately 44°C, or from approximately 42°C to approximately 47°C, with approximately 41°C to approximately 42°C providing a typical tissue temperature for treating tissue within the fat layer or other similar tissue located at a certain depth. In some aspects, a temperature range of approximately 41°C to approximately 42°C can be used to preferentially stimulate collagen development. Higher temperatures, up to approximately 46-47°C, can be used to target more damaged tissue, thereby providing more aggressive treatment, for example, in deeper tissue layers. However, a temperature range of 46-47°C may not be tolerated directly on the skin surface due to the discomfort experienced by patients due to the relatively high temperatures. In some aspects, the treatment temperature of the submucosal tissue can be able to tolerate higher temperatures, up to about 70 ° C, or about 40 ° C to about 60 ° C. The treatment time at a certain temperature can range from about 5 minutes to about 25 minutes, and can vary with, for example, the depth or volume of the target tissue. Therefore, it may be important to actively control the RF energy as discussed elsewhere herein so as to distribute the target tissue in the target treatment area substantially uniformly, predictably, and automatically (without user intervention) in a substantially homogeneous manner. In some embodiments, the tissue surface temperature (e.g., the skin surface and / or mucosal tissue surface) can be controlled during the treatment of tissue at a certain depth to maintain it within the range of about 15 ° C to about 40 ° C, or about 25 ° C to about 40 ° C. Due to the temperature control in the range of about 15 ° C to about 40 ° C or about 25 ° C to about 40 ° C on the skin surface, a higher temperature range (e.g., from about 46-47 ° C) at a certain depth can be tolerated during treatment.

[0183] Cooling the patient's skin surface can protect the epidermis and improve patient comfort. Adequate surface cooling (e.g., cooling water to a temperature of about 10°C to about 40°C, or about 25°C to about 40°C, or about 25°C to about 35°C) can allow for safe and comfortable application of higher RF powers than would be possible without such cooling. This can be important because most target tissue is located at a depth from the surface, so surface cooling serves to protect intervening tissue layers that are not targeted.

[0184] As discussed below, the electrode array can have various configurations, but in some exemplary aspects, the electrode array can be attached to an applicator that includes a metal coolant housing (e.g., via adhesive bonding or gluing). According to various aspects of the present teachings, an electrically insulating and thermally conductive layer (Kapton or ceramic, AlO2, etc.) can be located between a cooling housing (e.g., a reservoir or bladder containing temperature-controlled cooling water) and the electrode array so that the cooling water cools the electrode array and the patient's skin surface. As described above, the cooling water can be supplied from Figure 1A and 1B The console 110 circulates the cooling water via one or more pumps through one or more fluid conduits (e.g., via one or more umbilical cables 133 to corresponding applicators connected thereto), with a cooler / heater 138 configured to detect and / or maintain the temperature of the cooling water as needed.

[0185] The RF pulse duration for the target tissue selected for treatment

[0186] According to various aspects of the present teachings, various treatment protocols can be provided. In various aspects, long duration (e.g., greater than 1 second, CW) low power RF energy (e.g., about 1 W / cm2) can be contemplated depending on the biological target selection and biological target treatment. 2 to about 5W / cm 2 ) regimen and short duration (e.g., less than 500 ms, or less than 100 ms) high energy RF pulses (e.g., about 10 to about 1000 J / cm per pulse) 2 , 10J / cm 2 -500 J / cm 2 , 10J / cm 2 -300 J / cm 2 , 10J / cm 2 -100 J / cm 2) approach, and these two approaches can provide different benefits. Without being bound by any particular theory, the method of action can be thermal in nature, where the delivered RF power is used to primarily or preferentially heat (or even coagulate) selected tissue. Heat diffusion or conduction to adjacent tissues can also be contemplated as a treatment approach. More specifically, because different tissues have different electrical impedances and RF energy tends to propagate through anatomical structures or tissues that present the lowest impedance, connective tissue (e.g., fibrous septal tissue that interpenetrates fat layers) can represent a relatively low-impedance preferential path through which RF will be conducted. Therefore, heat will tend to accumulate in the relatively low-impedance RF conduction path. For example, the connective fibers of septal tissue will begin to heat relative to adjacent tissues. As the low-impedance tissues accumulate heat (e.g., exhibit an increase in temperature), they also begin to conduct heat to nearby adjacent tissues (such as fat, for example, which has a relatively higher electrical impedance than the connective fibers (e.g., septal tissue)). In accordance with the present teachings, it should be understood that the pulse duration of the applied RF can therefore provide a method for selecting anatomical target tissues, as discussed in detail below.

[0187] Short duration high power RF pulses can be used to heat or even coagulate low impedance tissue (e.g., connective fibers of diaphragmatic tissue), while long duration low power RF energy tends to heat low impedance tissue at a rate slow enough to conduct heat into adjacent high impedance tissue (e.g., fat). For example, by applying RF energy in short duration high power pulses, fibrotic structures can be heated rapidly without being able to conduct heat into adjacent higher impedance tissue (e.g., fat) quickly enough to dissipate the rapidly accumulated heat within the fibrotic tissue. Short pulse duration high amplitude RF power can therefore deposit a temperature increase in tissue with low electrical impedance within the treatment area (below the applicator). Short duration (e.g., about 10 ms to about 500 ms, preferably <100 ms) and high amplitude RF pulse energy (e.g., about 10 to 1000 J / cm 2) can be used to selectively treat low impedance tissue, such as diaphragms or other fibrotic structures within a patient's tissue. Because the bulk of the current will flow through fibrotic structures located in, for example, a more resistive, higher impedance fat layer, the rapid delivery of such short duration RF treatment pulses serves to preferentially accumulate temperature increases in fibrous connective tissue structures (such as diaphragms). Given the short duration of the RF pulse, the rapidly heated fibrotic structure cannot conduct heat quickly enough to the adjacent higher resistance tissue (e.g., fat) to offset the rapid accumulation of temperature increases in the fibrotic tissue. Therefore, this pulse duration effect can be used to "select" fibrous tissue or diaphragms to be treated by the accumulation of temperature increases, while the surrounding tissue remains relatively cool. This approach can be used to selectively heat fibrotic structures, such as diaphragms (the main component of fat masses that cause a cheese-like or dimpled appearance). This approach can be used to coagulate fibrotic structures in tissue, such as diaphragms. Although the example of diaphragms and surrounding fat is used, the ability to target or "select" tissues with different electrical impedances can be applied to many other tissue types or layers.

[0188] On the other hand, relatively long duration, lower power RF energy can preferably (more or less uniformly) heat tissue layers that present different electrical impedances. That is, longer pulse durations or even CW (continuous RF transmission) can be used to treat all tissue types within the treatment area because low impedance connective tissue / fibrotic tissue or diaphragms are heated slowly enough to allow heat to be transferred to the surrounding relatively high impedance tissue via thermal diffusion and / or thermal conduction. Therefore, the result is that all tissues within the treatment area (e.g., below the electrode array applicator) can be heated to a greater or lesser extent. Therefore, RF power with relatively low amplitude (e.g., about 1 to about 5 W / cm 2 ) or CW transmission (about 1 second to continuous (CW)) can be used to homogenously treat a tissue mass or area, regardless of the tissue composition within the area and its different tissue electrical impedances. Long pulse duration, low amplitude RF power tends to produce a temperature increase in all tissues in the target area by thermal conduction, regardless of the electrical impedance. Because adipocytes have a lower damage tolerance (high temperature tolerance) compared to connective fibers, adipocytes can be lysed while the connective tissue remains essentially intact. Therefore, the present teachings provide, for example, a method for lipolysis by providing low amplitude, long pulse duration (or CW) heating of the connective fibers (septa) and then heating the adjacent adipocytes. It will be further understood from the present teachings that the pulse duration can be fine-tuned to optimize the temperature accumulation in the desired target tissue while protecting the surrounding tissue from exposure to excessive temperature increases.

[0189] Electrode array

[0190] In various aspects, a large electrode surface (e.g., an electrode pad) can be divided into a mosaic of smaller electrodes (e.g., an array of multiple individual electrodes). The electrode array can have various configurations, but is typically configured so that the multiple electrodes constituting the array can be placed in electrical contact with the tissue to provide RF energy to the tissue. The individual electrodes constituting the electrode array can present various numbers of electrodes and have various shapes, sizes, and layouts (e.g., spacing). As a non-limiting example, suitable individual electrodes can each have a diameter ranging from about 3 mm to about 100 mm, from about 10 mm to about 70 mm, from about 10 mm to about 30 mm. In one embodiment, for example, the diameter of each individual electrode of a given electrode array can be measured to be approximately 1 cm. In some aspects, a group of electrodes in an electrode array or more electrode arrays can be arranged to have an area of ​​about 1 cm 2 to about 500cm 2 The electrode array can be formed into a certain shape, such as a hexagon, rectangle, circle, ellipse, diamond, trapezoid or other shape adapted to the specific tissue area to be treated. The number of individual electrodes in a single electrode array can also vary. In some aspects, for example, there can be about 2 to about 100 individual electrodes in the electrode array, while in another embodiment, there can be about 6 to about 20 individual electrodes in the electrode array. In one non-limiting example, 19 individual electrodes are arranged to cover about 20 cm 2 Larger areas of tissue can be treated by providing several applicators or electrode groups (e.g., several electrode arrays) that cover the desired tissue surface area.

[0191] Individually switched electrode arrays

[0192] It will be understood from the present teachings that by dividing a large electrode face into a plurality of small electrodes, a substantially uniform deposition of energy can be achieved, wherein each electrode within the array can be individually addressed and activated. To achieve uniform deposition of energy, one or more individual electrodes within the array can be individually addressed and activated based on tissue feedback (including temperature and / or impedance feedback), for example, as discussed further below. In some aspects, for example, only one electrode (or a subset of the electrode array) can be activated based on tissue feedback to help provide substantially uniform heating of the tissue. In other aspects, individually controlled electrodes can help ensure or control the heating zone to remain centered within the desired treatment zone location (e.g., below the electrode array applicator), as well as maintain a substantially homogeneous and consistent temperature rise within the desired treatment area, regardless of how the patient's underlying tissue electrical impedance changes, or regardless of nearby or adjacent anatomical structures.

[0193] For example, Figure 1A and 1BThe distributed electronics of the applicators 130a-d of the system 100 can be used to provide the same or different RF signals to the individual electrodes of the electrode array 160 to provide improved control of the treatment program, for example, by adjusting one or more of the power, RF frequency, pulse width and / or duty cycle. In these aspects, each individual electrode in the electrode array in contact with the patient can be independently addressed (e.g., switched to gate the RF power or duty cycle applied thereto), with each individual "channel" also being able to provide current, voltage and / or phase angle feedback information that can be used to calculate the power and impedance of the individual electrodes. In some aspects, the independently switched electrodes in the array can be switched (e.g., via the controller 137) to simultaneously gate RF power to each individual electrode in the array, or alternatively, the independently switched patient contact electrodes in the array can be switched to sequentially gate RF power first to one electrode in the array, then to another electrode in the array, until all or substantially all electrodes in the array have been addressed (e.g., during impedance mapping discussed below).

[0194] In some aspects, individually controlled RF electrode arrays can be used to disrupt connective tissue that interpenetrates fat layers (e.g., disrupting fibrous septal tissue present in cellulite through the septa). In such exemplary aspects, the electrode array can be placed over the tissue area to be treated, wherein the electrode array is provided with a short duration (e.g., less than 100 ms) high energy pulse (e.g., about 10 to about 1000 J / cm 2 ) in an array of multiple electrodes to target the diaphragm to be treated that is located beneath the electrode array. After a short pulse or series of pulses is completed by the first electrode (or subset of electrodes), another electrode or subset of electrodes in the array can be addressed with a short pulse or series of pulses, wherein the process is repeated until multiple electrodes or all electrodes in the array have been addressed with short duration high power RF pulses so as to target all tissue areas located beneath the array. Optionally, each electrode is addressed sequentially with short pulses of high power RF energy. In one embodiment, all or substantially all of the RF energy available to the entire electrode array is gated to a single electrode so that the diaphragm tissue is preferentially heated with relatively short pulses due to its relatively low impedance. Alternatively, a larger power supply is employed so that the desired and / or required high level of energy (e.g., about 10 to about 1000 J / cm 2 ) is gated to a single electrode, thereby preferentially targeting septal tissue.

[0195] In another embodiment, individually controlled RF electrode arrays can be used to disrupt connective tissue of interpenetrating fat layers and provide relaxation (and / or lipolysis). For example, an RF electrode array can be first used as described above to disrupt (e.g., rupture) a diaphragm in a tissue region beneath the array using relatively short pulses of high magnitude power. That is, after each short pulse is completed by one electrode (or subset of electrodes), another electrode or subset of electrodes in the array can be addressed with a short pulse, where the process is repeated to target all tissue regions beneath the array. Thereafter, the same electrode array can be used to disrupt the connective tissue of the interpenetrating fat layer by using relatively long, low power RF pulses (e.g., about 1 to about 5 W / cm 2 ) to heat the entire same tissue region (including the diaphragm tissue and other tissues in the region, including fat, dermis, hypodermis, and the dermis / hypodermis junction) to provide a relatively large amount of heating, such as for lipolysis and / or relaxation treatment. For example, after targeting the diaphragm tissue with short pulses of high power RF treatment, the RF electrode array can be used to treat the same tissue region for relaxation by simultaneously addressing all or substantially all of the electrodes with a relatively long pulse or series of long pulses (e.g., from about 1 second to continuous (CW)) and maintaining the target tissue within the treatment temperature range for an exposure time ranging from about 5 minutes to about 35 minutes, or from about 10 minutes to about 30 minutes, or about 25 minutes. It should also be understood that in some aspects, the tissue region can be first heat treated via long pulses from multiple and / or all of the RF electrodes in the array, followed by targeted treatment of the diaphragm via short pulses applied sequentially via one (or possibly several) of the electrodes in the array of multiple electrodes.

[0196] Flexible electrode array

[0197] According to various aspects of the present teachings, flexible electrode arrays are contemplated, wherein the electrode array allows for improved connection to curved surfaces or contours of a patient's body. In these aspects, the applicator array may include a plurality of electrodes (e.g., individually controlled electrodes), wherein each individual electrode unit presents, for example, approximately 1 cm 2 active area and includes a thin metal surface integrated on a flexible substrate. In some aspects, due to the limited thickness of the conductive material (e.g., metal) of the electrode, the individual electrodes can also be flexible (e.g., able to bend). Alternatively, the electrodes can include, for example, woven metal (e.g., copper) cloth, which itself is flexible to conform to the contours of the tissue surface. Thus, the electrode array can be composed of rows and columns of rigid or flexible electrode units arranged on a flexible substrate that is scaled to provide a range of 1 to 100 cm 2This flexibility allows for uniform treatment on both small and large scales. Custom-shaped array patterns are also contemplated, allowing for any shape suitable for a given treatment area. For example, a boomerang, rectangular, or trapezoidal shape could be used for submental or chin treatments. It will be appreciated that many variations in shape and size are possible in light of the present teachings. Figure 2B -D and Figure 2E -F show various electrode arrays suitable for conforming to and attaching to tissue surfaces having various non-standard shapes and a set of standard shapes, respectively.

[0198] Disposable applicator

[0199] In some aspects, an applicator (e.g., Figure 1A The applicator 130a) or a portion thereof can be provided as a disposable item. For example, the skin-contacting portion of the applicator containing the treatment electrode and a portion of the cooling conduit can be configured to couple to a non-disposable umbilical cable side (which couples the applicator to a console) containing relatively expensive distribution electronics, which can be removably coupled (e.g., via pins) to the electrodes in the disposable portion of the applicator. The umbilical cable side can also include one or more fluid conduits for delivering fluid to the disposable portion of the applicator (e.g., via one or more fluid coupling elements). In various aspects, a viscous gel can be applied to the surface of the applicator covered by a protective sheet. The sheet can be removed (e.g., torn off) and the applicator applied to the skin. Optionally, the viscous gel pad can be discarded after one or more treatments, while the remainder of the applicator can be reused. Alternatively, in some aspects, the entire applicator can be disposable. In these aspects, the relatively expensive accessories and circuitry can be relegated to the umbilical cable side, so that the cost of the disposable applicator can be minimized.

[0200] Now refer to Figure 2A , schematically illustrates a portion of another exemplary system for RF processing according to these and other aspects of the present teachings. Figure 2A A cross section of the skin is depicted, including the dermis, hypodermis (primarily fat), and muscle layers, with an exemplary RF applicator 230 bonded to the skin surface. As discussed elsewhere herein, the RF applicator 230 from the console (e.g., Figure 1A and 1BA coolant from a console 110 (with a temperature-controlled water circulator 138) flows through the cooling lines in the umbilical cable 233, and the flowing coolant can maintain the surface temperature of the skin while applying RF energy to the array 260 of electrodes 262 to heat the skin. The heat-cold ratio can regulate the skin surface temperature and can be used to adjust the distribution of heat within the skin so that a target treatment area (e.g., treatment depth) can be selected. In general, less cooling of the same RF power tends to shift the heating zone toward the skin surface (e.g., to tighten the skin and increase skin thickness by heating the dermis). If cooling is increased, the heating zone will tend to be pushed downward to the lower tissue layers. As discussed below, the short duration pulses of RF energy combined with cooling will tend to protect the skin (e.g., to prevent large tissue heating) while preferentially heating those tissues with the lowest impedance (e.g., diaphragm). In this way, regulation of the skin surface temperature can be used to adjust the distribution of thermal energy in the skin.

[0201] In various aspects, the disposable applicator 230 can also be flexible as described above and can include a tacky adhesive on the patient-facing side of the electrode so that the flexible pad adheres to the patient's surface. In some aspects, contact with the patient's skin surface can be via a tacky gel. Although in some aspects the gel layer can be thermally conductive to enable cooling of the skin, the gel layer need not be conductive because most of the power coupling can be capacitive due to the high RF frequencies used. Figure 2A As shown, for example, the disposable portion of the flexible applicator 230 can include an adhesive gel pad 263 that can be positioned between the electrode 262 that applies the RF signal and the tissue surface. In addition, a bladder 264 can be provided through which hot or cold water can flow, so that coupling of the disposable portion (i.e., below the dotted line) to the umbilical side of the applicator allows for the formation of a fluid pathway. As discussed below, the bladder 264 can be flexible so that the applicator 230 generally conforms to the contours of the tissue surface when applied (e.g., adhered thereto). Electrodes 262 are also shown dispersed within the applicator 230, each of which can be individually addressable in some aspects via leads that can, for example, be electrically coupled to pins of distributed electronics provided on the umbilical side of the applicator 230.

[0202] In some aspects, it is desirable to cool these electrodes and the area surrounding them, but it should be understood that, for some applications, cooling only a small portion of the applicator area may be effective. It is also shown that different amounts of energy can be applied to different electrodes depending on the underlying impedance; thicker fat has higher impedance and accordingly more energy is deposited. Figure 2AThe exemplary connector concepts shown in are intended to illustrate at least one non-limiting disposable concept where expensive components for accurate distribution of RF and monitoring electrodes are located on the reusable side, and the multi-trace array connector and water lines are formed as disposable parts (including relatively low-cost flexible electrodes).

[0203] Electrode and applicator geometry and surface coverage

[0204] Various geometries may be used for the skin / tissue contacting or skin / tissue facing area of ​​a given electrode array. Figure 2B -C shows a representation of a patient 211 who is a candidate for one or more RF-based cosmetic treatments, medical treatments, or other tissue surface treatments. The patient may have: a treatment area 275 to which an applicator including an electrode array has not been applied; and other areas to which various electrode arrays based on non-standard shaped tissue surface contact applicators (such as a semi-circular applicator 277a and an elongated trumpet-shaped applicator 277b with slightly rounded or rounded corners) have been applied. Two semi-pear-shaped applicators 277c can also be used to cover the abdomen or other treatment areas of interest of a given patient. Complementary applicators 277b, 277e can also be used near the edges of other specialized non-standard applicators. Complementary applicators can be side piece applicators located on both sides of a larger main applicator. Various complementary applicator embodiments 277b, 277e are shown. As shown Figure 2C As shown, the complementary applicator 277e is tightly coupled with the two half-pear-shaped applicators 277c to cover most of the abdominal area of ​​the patient 211.

[0205] Other non-standard applicator shapes may be used, but are not limited to, such as a rounded wedge-shaped applicator 277f and a complementary applicator 277e that includes a curved border that mimics the curve of the rounded wedge-shaped applicator 277f. In one embodiment, a primary non-standard electrode is packaged or otherwise provided with other non-standard complementary applicators that track one or more edges or borders of the primary non-standard applicator to efficiently cover or surface the treatment surface with a minimum amount of uncovered tissue in a given treatment area.

[0206] Generally, when gaps exist between the electrode arrays, the gaps between the electrode arrays of the applicator can result in irregular treatment and undesirable boundary effects, such as ridges or other anomalies caused by uneven fat breakdown or other variations in tissue response. In one embodiment, the main applicator is sized to cover a larger surface area relative to a smaller complementary applicator. In one embodiment, the surface area covered by a given main applicator is in the range of about 100 cm 2 to about 300cm 2In one embodiment, the surface area covered by a given primary applicator is in the range of about 150 cm 2 to about 250cm 2 In one embodiment, the surface area covered by a given complementary applicator or side piece applicator is in the range of about 50 cm 2 to about 100cm 2 .

[0207] In one embodiment, the surface area covered by a given complementary applicator or side piece applicator is in the range of about 70 cm 2 to about 120cm 2 The above ranges can also be used to specify the area of ​​a set of standard applicators, where each applicator in the set has the same shape.

[0208] Figure 2E -G shows a patient 211 who is a candidate for one or more RF-based cosmetic, medical, or other tissue surface treatments and a representation of various standard conformal applicators 280 in place or adapted or placed over an uncovered treatment area 275. Figure 2B Compared to the non-standard applicators described in -D, the use of standard applicators (such as Figures 2E-2G The rectangular applicator 280 shown has the advantage of being able to tile or cover the tissue treatment area without having to use special shapes that are more expensive to manufacture. The use of standard applications allows such applicators to be sold in kits or other groupings. These applicators typically include a gel pad for adhering the applicator's electrode array to the tissue surface. These applicators effectively fill the space on the tissue surface and reduce the number of gaps. Regular polygons, fractal shapes, pairs of complementary shapes, and other repeating patterns can be used to specify kits of standard applicators that effectively cover the surface area required for a given treatment regimen.

[0209] Figure 2H is a schematic diagram of a target area 285 on a patient's tissue surface. For various tissue types or due to other limitations imposed by patient-specific parameters and the desired outcome of a particular treatment regimen, it may often be desirable to have an electrode array fixed to the skin surface. These electrodes can be placed and maintained in place during treatment. These conformal electrodes are also described above with respect to Figure 2B -G describes the type of implementation used in this article. Figure 2H A specific example of a standard applicator shape with an electrode array is described and depicted. A variety of materials with suitable adhesive properties can be used to attach the applicator 280a to the tissue surface. Additionally, the adhesive material can be tailored to release from the skin in response to manual manipulation.

[0210] To affect RF-based treatment of the target area 285, various electrode array geometries may be used that are space-filling or otherwise amenable to efficient tiling of the surface such that gaps between applicators are reduced. Figure 2B -D describes a variety of specialized electrode geometries, and while such specific geometry designs are suitable for specific procedures and use cases, factors such as manufacturing and per-unit cost may come into play when a given electrode is a single-use device.

[0211] As shown, the target area 285 has an irregular border. Custom electrodes for this border are expensive to manufacture and may have limited applicability to candidates in the general population for RF treatment. Therefore, in one aspect, the present disclosure relates to a kit or collection of attachable electrode arrays comprising a set of electrode arrays that can be positioned and aligned to efficiently fill a two-dimensional area with K shapes for each given kit. K can range from 1 shape to about 20 shapes. In other embodiments, K can range from about 1 to about 10 shapes. In other embodiments, K can range from about 1 to about 5 shapes. K can also be a positive integer greater than or equal to 1 and less than 50. In one embodiment, these shapes are selected so that they are all the same shape, such as shown by the square electrode 280a with a dotted border. The square shape of the electrode 280a effectively tiles the area defining the treatment area 285. Pairs of shapes (such as hexagons and pentagons) and other similar groupings can be used to cover a certain area while reducing the gap between the applicator edges.

[0212] As described above, a cooling water flow path can be supplied to the flexible electrode, which is thermally conducted through the electrically insulating layer to the back side (non-patient connection side) of the electrode so that the cooling water controls the patient's skin surface temperature during treatment. For example, Figure 3A An exemplary flexible cooling bladder layer 305a is depicted for a flexible applicator configured to flex over a compound curve, such as the submental area or flank. Thus, a multi-layer adhesive pad design can include electrodes made from thin copper-plated foil or fine copper-plated fabric (e.g., die-cut) and embedded in an adhesive laminate. Figure 3A The flexible cooling water manifold / bladder layer 305a depicted in FIG can include a top layer of a disposable pad, wherein the manifold uses two layers of polymer sheets (e.g., die cut and heat bonded in a maze pattern at various locations 310) to define one or more fluid flow paths 312 therebetween. In various aspects, the electrodes can be cooled directly with water rather than relying on conduction through a flexible substrate. Parallelograms, squares, rectangles, trapezoids, regular polygons, and other shapes can be used to provide such a kit that includes one or more applicators sized and shaped to effectively cover or drape a tissue surface.

[0213] Can be used with Figure 3A The electrode layer used in association with the flexible cooling bladder layer 305a can be any electrode array otherwise discussed herein, including in association with rigid, semi-rigid, conformable, hybrid, or flexible electrode arrays as described above, for example, with reference to Figures 1A-1F and Figure 2A system and Figure 3A -F and 3I-3X applicators. Various cooling bladder embodiments can be integrated with different applicator designs. For a given applicator design, the bladder can be sandwiched between one or more layers or other components. Various exemplary alternative cooling bladder embodiments are described and depicted in more detail. In some embodiments, the cooling bladder is part of an applicator that includes a disposable portion and a reusable portion. In turn, each of the disposable portion and the reusable portion can include various components and subassemblies.

[0214] Figure 3B An applicator 320A is shown that can be implemented as an applicator that is held in place using fasteners, or it can be used with an adhesive sheet or strip and adhered to a given patient as a conformable applicator. Applicator 320A is a hybrid applicator that can be combined with an attachment device or adhesive (such as the gel pad disclosed herein). In addition to the mechanism for securing it relative to the target tissue area, applicator 320A is also a hybrid applicator because it can include disposable and reusable components. When adhesive is not used to attach applicator 320A to the tissue surface, various mechanical attachment devices such as bands, clamps, strips and other devices can be used.

[0215] In one embodiment, the strap 317 is used in conjunction with an applicator coupler 319 that includes a slot or other mechanism to receive the strap. The applicator coupler 319 is shown as including two slots to receive and slidably secure to the strap 317. This is only one possible configuration of the strap 317 and the applicator coupler 319. The strap and coupler can have various shapes and configurations, as long as they help secure the applicator 320A to the patient during a given treatment session. The applicator coupler 319 includes a bottom surface having a deformable cylindrical shell with slits 318 spaced along the sides. The slits facilitate expansion of the cylindrical shell and gripping of one or more raised structures 340d, 340e on the applicator so that the strap can be selectively secured and removed from the applicator 320a.

[0216] In one embodiment, the applicator 320A includes a plurality of electrodes (not shown) that are individually addressable and formed into an array disposed on a first surface 340a. The surface or support 340a is applied to the skin or another tissue targeted for treatment. Although shown as a single surface or structure, the support 340a can be formed from multiple layers, for example, the layers can include one or more of electrodes, electrically insulating materials, thermally conductive layers, electrical leads, contacts, and the like.

[0217] In one embodiment, the applicator also includes a second support 340b disposed on or adjacent to the first support 340a. The second support 340b may include one or more compressible materials, such as foam or other flexible materials that conform to the contours of the patient. The second support may include a slot, clip, or other attachment mechanism so that it can be separated from the other components of the applicator to facilitate reuse of one or more components of the application. The applicator 320A also includes a third support 340c, which includes a rigid or semi-rigid material forming the upper surface of the applicator 320A. The third support may include one or more attachment mechanisms to interface with a band or other device to secure the applicator to the tissue surface so that the electrode is in close proximity to or contact with the tissue surface. The third support 340c and the second support 340b are designed to slide or tear along pre-scored lines or areas to facilitate reuse of the rigid or semi-rigid third support 340c.

[0218] The electrode array of the applicator can be formed in or on a flexible substrate, such as by print deposition or other manufacturing techniques. Such a flexible substrate can constitute one or more layers of the first support member 340a. Each electrode is connected to an electrical trace or lead that extends and connects to one or more other electrodes or electrical contacts. For example, as shown, the flexible substrate 350a can be part of the first support member 340a and extend from the first support member as a tab or flexible strip. As shown, the portion of the flexible substrate 350a extending from the rear side of the applicator has multiple electrical contacts. Each such contact 350b is in electrical communication with one or more electrodes that are arranged on the tissue-facing surface of the support member 340a relative to the skin contact surface applicator. In various embodiments, these contacts 350b can be electrical traces or printed electrical leads or other electrical leads.

[0219] The applicator may also include one or more cooling mechanisms 305, such as a closed loop bladder having multiple flow channels, e.g. Figure 3A As shown. Figure 3BAs shown, two fluid delivery ports 351 are shown to support the entry and exit of cooling fluid. During a given treatment session, water or another suitable coolant is circulated into one port 351 and out of the other port 351 after circulating through a series of channels within the applicator to draw away heat and thereby cool the treatment area receiving RF energy from the electrode array. Figure 3C An alternative view of an applicator 320A is shown with the port and flexible substrate 350a shown previously.The two-dimensional and three-dimensional shapes of each of the first, second and third supports can vary in a nearly infinite range of shapes.

[0220] Although the overall shape of the first support member 340a is generally square or generally rectangular, the shape of the support member and its surface can be any suitable regular or irregular shape. Figure 3D , an alternative applicator embodiment 320B is shown that includes a circular first support 340g. Similarly, the second support 340b is also shown as having a surrounding or curved shape. In addition, Figure 3E and 3F Two further alternative embodiments of applicators 341a, 341b are shown, which are triangular and crescent-shaped, respectively. The applicators and their tissue-contacting surfaces can comprise any suitable two-dimensional shape, including regular and irregular shapes. These shapes are shown as examples, and any suitable shape can be used in various embodiments. These embodiments can include a fluid flow path 351 for the cooling bladder and also include an electrical connector 350d, which can be a flexible substrate or include wires or other electrical conductors.

[0221] Figure 3G A flexible applicator embodiment 325A is shown. An exploded view of the applicator 325A is shown in FIG. Figure 3H . The applicator 325A includes a plurality of temperature sensors 364. Suitable temperature sensors may include thermistors, but other devices may be used. The applicator also includes a flexible electrode 362. The electrode 362 may be an electrode array. Figure 3G and 3H An embodiment of an electrode without mapping and cooling is shown, which provides the opportunity to provide substantially uniform heating and flexibility to provide good consistency to the target treatment area. Figure 3G and 3H, but for a given flexible applicator embodiment 325A and variations thereof, an array of electrodes may be used in other embodiments. The applicator may include one or more adhesive regions 370, which are generally disposed around the perimeter of the applicator 325A. Regions 370 may include a gel or other material. A cable 368 has terminal contacts or connectors 368a. The cable 368 (such as an RF transmission cable) is attached to the applicator at connection terminals or electrical contacts 369. In one embodiment, the connector 368a of the cable 368 receives the contacts 369.

[0222] like Figure 3H As shown, the applicator 325A may include one or more coatings 361 to aid in manufacturing or contact with the patient. These may include multiple gels, a single gel, a Kapton pad, or other materials. In the exploded view, various electrical traces or leads 365 are shown. These are in electrical communication with a cable 368. As shown, the applicator may also include an electrically insulating and thermally conductive layer 367. The various layers of the applicators and electrode arrays described herein may include one or more electrically insulating and thermally conductive layers (e.g., between the cooling device and one or more electrodes or electrical connectors) located between the cooling device and one or more electrodes or electrical connectors. Polyimide or ceramics such as AlO2, etc.). In various embodiments, different dielectric materials can be used to form part of a given electrode array or otherwise support or position the metal layers and conductor traces. In various embodiments, Kapton can be used as a suitable dielectric material, but other dielectric materials suitable for RF applicators used for patient-directed applications can be used.

[0223] For various RF delivery applicator embodiments, suitable dielectric materials may include Kapton and other polyesters. In these embodiments, the dielectric material is selected to have some of the following properties: a dielectric constant in the range of about 3 to about 4, which provides a good balance of capacitance and dielectric thickness; flexibility; the ability to conform to the patient's tissue geometry (such as the skin surface geometry); low thermal energy loss / dissipation factor; tissue-safe, skin-same, biocompatible, cost-effective, high-temperature resistant to allow welding without damaging the material; and strong and durable.

[0224] Figure 3I Another applicator embodiment 327B is shown in a first view with the tissue-facing surface facing downward, and in a second view with the tissue-facing surface facing upward such that the electrode 380 is visible. Figure 3J Shown Figure 3IExploded view of applicator 327B. Applicator 327B is a hybrid applicator that includes disposable and reusable components. A rigid or semi-rigid housing 371 protects some components nested therein, such as a printed circuit board stack 372. A rigid substrate 374 (which is typically a hard polymer, such as plastic) sandwiches the PCB stack 372 in the middle so that the stack is fixed in the housing. The rigid substrate 374 may include one or more elongated members 374m, 374n or fins extending therefrom. These members can be received by slits or grooves 374r, 374s in the PCB stack 372 or in the housing 371. In one embodiment, the three components of the housing, the rigid substrate, and the PCB stack can be considered as a set of reusable elements.

[0225] There may also be a compressible or conformable substrate 376, such as a foam layer. Figure 3J and 3N As shown, a cooling bladder 305b is also present in some embodiments and is used to cool tissue during exposure to RF treatment. The cooling bladder 305b is connected to a fluid delivery line 377. The flexible electrode array 378 is Figure 3J The bottom element shown in FIG. The array of 48 electrodes as part of the flexible array 378 is Figure 3I Flexible or rigid electrical traces or leads 311 can be bent around and connected to the electrode array 378, as shown in FIG. Figure 3J As shown. Applicator 327B includes a cable 368 extending from housing 371, which is suitable for transmitting RF signals and receiving impedance measurements. In part, the present disclosure relates to a quick release connector (such as Figure 3N These arrays facilitate cooling and allow for quick start and end of procedures using quick release connectors. In one embodiment, various bladder designs also benefit from disposable components.

[0226] Figure 3K -S shows Figure 3I and 3J An image of an alternative embodiment of the various components of the applicator 327B is shown. Figure 3K A bottom view of the PCB stack 374 is shown in combination with the foam layer 376 and electrode array and cooling bladder 305b. Figure 3L A perspective view is shown showing the rigid base plate 374 and the input and output 377 of the cooling bladder. Connectors for the fluid input 382a and output 382b are also shown. Figure 3L and Figure 3N The grooves or slits 374s, 374r of the PCT stack 372 are shown in FIG. Figure 3M374n, m. These slots or grooves may also be formed in the housing 371 or not used in some embodiments.

[0227] Figure 3O A top perspective view of an electrode array 380 and an exemplary electrode 381A is shown sandwiching a foam layer 376 and a rigid substrate 374. Figure 3P The flexible substrate 381 forming the electrode array 380 is shown. Figure 3O The electrode array 380 and the rigid substrate are shown. The flexible substrate includes various individual electrodes, such as electrode 381A, connected to one or more electrical leads or traces 311. Various electrical contacts or traces formed along the flexible substrate 381 are shown. Figure 3Q These traces are also shown on either side of the foam layer 376 in FIG. The arrangement of the flexible substrate 381 with electrodes 381A as part of the array and the conformable / compressible layer 376 in combination with the substrate 374 provides the benefits of a conformal applicator while facilitating the placement of the flexible substrate array and the conformable / compressible layer while saving on expensive reusable electronic components.

[0228] Figure 3R-3T and Figure 3U Alternative applicator embodiments 333A and 333B are shown that incorporate rigid electrode arrays 395a, 395b and individual electrodes 394. Housings 388a, 388b are used to protect various electronic components, such as those on a PCB stack 390. A cooling bladder 305c is also incorporated with cooling inlets and outlets 377. These inlets and outlets extend from the housing at one or more channels 393. As described herein, a cable 368 provides signals and power to the array and is in electrical communication with various control nodes. These rigid applicators are particularly suitable for scanning patients and generating data before and after impedance scans, as well as other data derived therefrom. As discussed herein, various types of applicators can be used to perform RF-based tissue treatments. In addition, for each applicator, different electrode sizes can be used in a given single electrode or electrode array embodiment.

[0229] Electrode size and spacing

[0230] Electrode size and spacing can be manipulated to achieve desired RF deposition uniformity while maintaining flexibility and reducing electrical complexity. The area is approximately 1 cm 2The rigid portion of the electrode can provide sufficient area to safely couple RF power to the skin (e.g., in the absence of high flux) and still allow flexibility between adjacent electrodes to adapt to the contours of most anatomical structures. If the electrode itself is flexible (such as woven copper cloth), the size limit of the electrode can be controlled by the edge effect, where the high frequency is concentrated at the periphery of the electrode, resulting in uneven RF deposition and, therefore, uneven heating. By balancing the edge effect with the thermal properties of the tissue, the electrode area can be optimized to provide substantially uniform heating of the skin and underlying tissue. The spacing or distance between adjacent electrodes in the array can also be optimized to heat the target area within the treatment time. Suitable spacing between adjacent electrodes can range from about 0.1 mm to about 2 cm, for example, from about 1 mm to about 1 cm. In the case of resistively coupled electrodes, suitable electrode diameter sizes can range from about 3 mm to about 20 mm, or about 10 mm. In the case of capacitively coupled electrodes, suitable electrode diameter sizes can range from about 3 mm to about 200 mm, or about 10 mm.

[0231] In the case of partial ablative RF treatment discussed below, for example, the size and spacing can be relatively small, ranging from about 0.1 mm to about 10 mm, or about 0.5 mm to about 5 mm, in an electrode array, with each electrode in close proximity to each other to cover substantially the entire applicator area. This is because, in the case of partial ablative RF treatment, the pulses are so short (e.g., less than about 100 ms, or about 5 ms to about 35 ms) that there is no time for heat diffusion between the specific tissues addressed by each electrode, whereas relatively high energy short pulses can ablate the tissue.

[0232] In the case of tissue heating and relaxation applications, exposure times can be long (e.g., 10-30 minutes), where the thermal properties of the skin / fat dictate the heat distribution and allow the use of larger electrodes and larger spacing to achieve substantial heating of the tissue.

[0233] In the case of septum disruption, short duration high power RF pulses are delivered to the target tissue and one can use a single electrode or an electrode array and the electrodes can be applied to the tissue as discussed herein and used in a hands-free manner, and due to the short pulses associated with septum disruption, the single electrode or electrode array can be constructed as a handpiece for use in a stamping mode.

[0234] Electrode cluster

[0235] In some aspects, electrode clusters (i.e., nodes comprising multiple electrodes of an array sharing a common electrical control) can be used to reduce electrical complexity while still utilizing smaller electrodes, which helps improve uniformity, flexibility, and reduce edge effects. In the simplest case, instead of driving each individual electrode in the electrode array, clusters of two, three, or more electrodes can be similarly controlled (e.g., the same RF signal), because the resolution of the thermal effect may not require more specific control, however maintaining a large number of electrodes may be preferred. For example, electrode clusters can be used to treat connective tissue that interpenetrates fat layers (e.g., the fibrous septa present in cellulite) by pulsed with a short duration high power RF pulse to one electrode cluster in the electrode array and then with a short duration high power RF pulse to another electrode cluster, and so on, until all or substantially all of the electrode clusters in the array have been addressed. In one embodiment, all or substantially all of the RF energy available to the entire electrode array is gated to a single electrode cluster so that the diaphragm tissue is preferentially heated by the relatively short pulses due to the relatively low impedance of the diaphragm tissue. Alternatively, a larger power supply may be employed so that a high level of energy per pulse (e.g., about 10 to about 1000 J / cm2) is desired and / or required. 2 ) can be gated to a separate single electrode cluster to preferentially target septal tissue. As discussed further below, real-time monitoring and / or knowledge of the impedance of each electrode (or a majority of electrodes or substantially all electrodes) can enable determination of the integrity of each electrode (or a majority of electrodes or substantially all electrodes) contact with the tissue, thereby avoiding inadvertent overtreatment of areas smaller than the target area (e.g., burns can be avoided).

[0236] Patient impedance mapping

[0237] According to various aspects of the present teachings, various detection and / or feedback mechanisms are envisioned to help provide improved RF treatment. As discussed below, RF treatment uniformity can be achieved by using tissue impedance mapping alone or in combination with surface peripheral temperature feedback. In some aspects, the patient's tissue impedance can be "mapped" by detecting the impedance of the tissue area to be treated (or being treated) so that impedance differences can be compensated, for example, by controlling or modifying the distribution of RF power (or total treatment time, or duty cycle) delivered through each individual electrode in the electrode array based on information collected via impedance mapping and / or surface peripheral temperature feedback. Such impedance mapping can adjust and / or prevent heat from accumulating in non-target areas (e.g., outside the periphery of the applicator). Such impedance mapping can adjust and / or prevent non-uniformity in the treatment area (whether due to anatomical changes or changes in tissue layer thickness) and / or unexpected non-uniformity in RF deposition.

[0238] In some aspects, electrical impedance mapping of the individual electrodes in the electrode array can be performed by polling the electrodes of the electrode array placed against the patient tissue surface to determine the individual impedances of the tissue between each electrode pair in the pair of applicators, and therefore the impedance of the corresponding tissue beneath each electrode. For example, the mapping step can be performed at very low RF power (e.g., a sub-treatment power that does not substantially increase the temperature of the tissue) with two exemplary electrode arrays placed in contact with the tissue surface (or with different tissue surfaces). Impedance can then be detected for each combination of an electrode from one array and an electrode from the other array, for example by selectively activating individual electrodes. After the tissue impedance of a combination is determined, the electrodes can be deactivated and other electrodes can be "polled" to determine the impedance along that particular path, and so on, until each individual electrode in both arrays (e.g., in the left and right arrays) is addressed.

[0239] Alternatively, the process can be repeated so that only each individual electrode in one array is addressed. In this way, tissue impedance will be measured in the tissue beneath each electrode in the array. It will be appreciated that the process can be repeated at different RF frequencies and can be performed immediately prior to applying the RF treatment power or at different times during treatment. For example, this initial step of impedance mapping can be performed in less than about one minute (e.g., about 30 seconds). Based on these measurements, it will be appreciated in accordance with the present teachings that, for example, the relative thickness of the subcutaneous fat layer can be calculated due to the impedance differences between fat and muscle. Impedance mapping of the patient beneath each discrete electrode provides a corresponding tissue impedance map of the entire treatment area.

[0240] In addition to having such mapping on an electrode-by-electrode basis, one or more applicators may be scanned across the patient's tissue to produce a baseline map or report that may include various representations showing impedance values ​​or values ​​derived or calculated based on such values ​​including variations in fat layer thickness, muscle area, tissue type, and other tissue specific parameters such as tissue type, hydration level, etc. Figure 2A Exemplary applicator-based scanning of multiple areas of a patient is shown and discussed in greater detail herein. Furthermore, multiplexed mobile or fixed arrays can also be used to scan treatment of mucosal tissue, such as vaginal tissue. Arrays can be selectively addressed so that a series of electrodes are energized to cover different tissue areas.

[0241] Therefore, as mentioned above Figures 1A-1FAs discussed, the distributed electronics of the applicator 130a can be utilized to provide the same or different RF signals to individual electrodes 162a of the electrode array 160a in order to provide improved control of the treatment procedure. In some related aspects, the distributed electronics can also be controlled so that each electrode in the electrode array can be independently switched (e.g., to gate RF power to the individual electrodes), with each individual channel providing current, voltage, and / or phase angle feedback information that can be used to calculate the power and impedance of the individual electrodes. For example, to map a tissue, the independently switched contact electrodes in the electrode array can be switched during an exemplary impedance mapping step to sequentially gate RF power first to one electrode in the array, then to another electrode in the array, until all or substantially all electrodes in the array have been addressed, as described below with reference to Figure 4A It should be noted that although Figure 4A The impedance mapping steps are depicted between two electrodes in two different applicators, but one skilled in the art will understand that such description is equally applicable to any number of applicators and electrode arrays.

[0242] like Figure 4A As schematically shown in FIG, two applicators 405a, 405b can be placed in contact with a tissue surface, wherein each applicator includes an array 410a, 410b of 16 electrodes 408. When these applicators are coupled to the tissue surface at the intended treatment location, an impedance mapping step can be performed before applying treatment RF energy (i.e., energy with sufficient power to achieve treatment in the target tissue) to determine the impedance (the resistance of the tissue to the RF energy) for each combination of one electrode 408 from applicator 405a and one electrode 408 from applicator 405b. For example, the electrodes 408 of both applicators can be selectively activated to run very low RF currents (e.g., sub-treatment energies) from A1 to B1, A1 to B2, A1 to B3, and so on, until a 16x16 matrix of resistance values ​​is generated, such that the tissue resistance between each electrode in applicator 405a and each electrode in applicator 405b is known. When applicators 405a, 405b are positioned adjacent to each other on tissue as shown (e.g., as opposed to being positioned away from each other or on opposing tissue surfaces), it is generally observed that the lowest impedance will be present between adjacent edges of applicators 405a, 405b. That is, the resistance measured between A4 and B1, A8 and B5, A12 and A9, and A16 and A13 will tend to be among the lowest impedances measured (depending on the tissue type, as discussed elsewhere herein). Such observations indicate that, during treatment, the highest RF current and the highest heating will also occur along these low impedance paths.

[0243] The impedance topography revealed by this method can thus identify changes in the electrical impedance of the patient's tissue and can therefore be used to reallocate or adjust the RF power and / or treatment time delivered to each discrete electrode in order to improve the uniformity of heat deposition (temperature increase) to achieve more effective fat destruction, skin tightening, collagen heating or diaphragm targeting, as well as to center the treatment area below the applicator (e.g., electrode array) to achieve a more uniform tissue temperature. For example, a separate electrode that detects a lower impedance relative to the average impedance of all electrodes will tend to deposit more RF energy (and cause a relatively larger temperature increase) than an electrode that encounters a higher impedance. Therefore, in order to homogenize and center the treatment area within the treatment area, the impedance topography can be used to select separate electrodes at lower impedance locations to reduce RF power and / or select separate electrodes at higher impedance locations to increase RF power. The increase or decrease in RF power delivered via the separate electrodes can be proportional to the change in electrode impedance relative to the mean or average electrode power. Therefore, in some aspects, the distributed electronics of the applicator can be used to adjust the RF signals to the individual electrodes of the electrode array to account for impedance differences. For example, the independently switched contact electrodes 408 in the arrays 410a, 410b may be switched (e.g., Figures 1A-1F 137) to modify the RF power provided to each individual electrode 408 to help evenly deposit thermal energy within the processing area.

[0244] Reference again Figure 4A , the data collected during the impedance mapping step can be used to adjust the electrode activation pattern (e.g., RF power, pulse width, total treatment time, duty cycle) to help maintain uniform heating under the applicators 410a, 410b. For example, one possible approach to mitigating edge effects between electrodes at adjacent edges is to alternate between activating electrodes A{1, 2, 5, 6, 9, 10, 13, 14} and B{1, 2, 5, 6, 9, 10, 13, 14} during a first duration (while the other electrodes are inactive) and activating electrodes A{3, 4, 7, 8, 11, 12, 15, 16} and B{3, 4, 7, 8, 11, 12, 15, 16} during a second duration to promote more uniform spacing and more uniform heating. Alternatively, the RF power to electrodes A{4, 8, 12, 16} and / or B{1, 5, 9, 13} can be significantly reduced and / or permanently disabled, for example, during the duration of the treatment. The electrodes in the second to adjacent rows between the applicators, i.e., electrodes A {3, 7, 11, 15} and B {2, 6, 10, 14}, still have a slight tendency to transfer current laterally to each other, thereby heating the area under the closed electrode. For example, this pattern (e.g., generated by the distributed electronics under the influence of the controller) will allow for more uniform heating under two adjacent electrodes operating in bipolar mode.

[0245] Additionally, the RF power applied to each electrode 408 can also be tracked and controlled during treatment, with ongoing impedance monitoring (e.g., sampling) being employed to track changes in tissue impedance and, based on this feedback, the power at each array location can be adjusted accordingly and / or the endpoint of treatment can be determined. For example, during treatment, the distribution electronics can be controlled so that each electrode 408 in the electrode arrays 410a, 410b can be sampled occasionally (e.g., by gating RF power to the individual electrodes), with each individual "channel" providing current, voltage, and / or phase angle feedback information that can be used to calculate the power and impedance of the individual electrodes. That is, this impedance mapping can also be performed in real time during treatment (e.g., at intervals during treatment). Ideally, this control feedback mechanism can inform a power equalization algorithm to monitor and / or adjust treatment conditions. Such impedance mapping is particularly useful during the early stages of treatment, e.g., before temperature changes have accumulated on the tissue surface adjacent to the target treatment area, which temperature changes can be detected by a temperature detector as discussed in detail below. Later in the treatment, when an increase in surface temperature can be observed, the impedance mapping feedback can optionally be added to the feedback provided by detecting the tissue surface temperature (e.g., around the periphery of the applicator) to provide additional feedback information. Adding these two feedback mechanisms together (e.g., taking 50% of the RF correction factor from the impedance topography and 50% of the RF correction factor indicated by the surface temperature observation) is one non-limiting exemplary approach. As a non-limiting example, another feedback method would be to switch to using the surface temperature feedback method after a detectable difference in surface temperature (e.g., a difference of 1 / 2 to 1 degree Celsius or greater) becomes apparent. According to various aspects of the present teachings, impedance mapping can also be relied upon entirely to reallocate the RF power applied through each electrode to achieve optimal treatment placement, optimal homogeneity, desired uniformity, and to obtain temperature information about the target tissue (e.g., tissue beneath the skin or mucosal surface).

[0246] Figure 4B A patient 420 is shown as a candidate for one or more RF-based treatments. One or more applicators described herein or other RF applicators or delivery devices may be used to scan one or more tissue surfaces of the patient to generate an impedance map. Figure 4B , the skin of the patient and the skin of the torso are scanned. The scanning can be performed by moving an applicator (such as applicator embodiment 315C) along the surface of the patient 420 according to various scanning patterns (such as shown by the exemplary directional arrows shown). Any suitable scanning pattern can be used.

[0247] As an alternative to moving one or more applicators across the tissue surface at one or more time instances, a set of applicators or electrode arrays can be placed on the patient and scanned by multiplexing / selectively addressing different electrodes, or by collecting impedance measurements about the tissue.

[0248] In general, scanning a patient over time before and after treatment has various beneficial consequences for users of the RF-based treatment systems herein. Time measurements can be obtained over the course of one or more treatment sessions. In some embodiments, one or more impedance maps are obtained related to a candidate tissue region for treatment before a treatment session begins. Figure 4B The left-right and up-down scanning patterns shown by the center arrows are examples of scan types that can be performed to identify impedance values ​​associated with different locations on a patient and their associated fat distribution. Impedance values ​​can be correlated with areas of increased fat / high fat levels (HF) relative to the same threshold, and decreased fat (LF) relative to the same or different thresholds. The boundary between higher fat levels (HF) and decreased or lower fat levels (LF) is shown by dashed lines. Other markings and representations can be displayed on the representative tissue scan. Based on the displayed scan results, it is apparent that the lower torso and upper thighs may require additional treatment due to increased fat levels (HF).

[0249] In this way, a "before" impedance map can be generated and stored for subsequent comparison with other impedance maps over time. Such "before" or pre-treatment impedance maps and "after" treatment impedance maps can be used to provide evidence of treatment effectiveness, increase and maintain patient motivation in assessing the benefits of ongoing treatment, and also provide diagnostic information related to treatment parameters (such as fat levels and fat loss over time).

[0250] Figure 4C Two sections of a patient 425 are depicted in which RF-based tissue treatment is being performed on the patient, wherein multiple tissue regions are being treated. Specifically, multiple RF applicators 430a, 430b, 430c, 430d, and 430e are used and placed in contact with the patient. Although any suitable applicator may be used, a conformal applicator or a rigid applicator is preferred. Figure 4CThe multi-zone treatment shown is typical. Applicators 430a, 430b are positioned in a first treatment zone, Zone 1, comprising the upper back torso, while applicators 430c, 430d, and 430e are positioned in a second treatment zone, Zone 2, comprising the upper back portion of each thigh. The applicators shown can be held in place using one or more attachment mechanisms, such as straps, clips, clamps, straps, fasteners, and other devices suitable for holding the applicators in a given position relative to the target treatment area of ​​the patient 425.

[0251] Alternatively, the applicator can be adhered to the skin of each treatment area using a suitable adhesive strip, gel, gel pad, sheet or other adhesive area that can hold the applicator in place, but can be removed at the end of the treatment without causing discomfort to the patient. As shown, each applicator is in electronic communication with one or more RF system components 440a, 440b. These components 440a, 440b may include a console (such as the console 110 described herein) or one or more components or subsystems of a given console 110. The applicator is in electronic communication with one or more electronic devices (such as one or more control nodes discussed herein). In one embodiment, the RF drive electronics are disposed in the applicator.

[0252] Each applicator can have one or more leads and one or more cables to provide control signals, power, transmission impedance measurements, or other electronic signals as disclosed herein. For example, each applicator can include one or more transmission cables. In one embodiment, the distance (or straight-line distance) of the cable segment between the output of the control node 444 and the connection point of the transmission cable to the applicator 430e is S. In one embodiment, the control node 444 is a controller that generates control signals to measure the individual currents of one or more electrodes of the electrode array of the applicator 430e. Each applicator used in a given embodiment can be directly or indirectly connected to one or more control nodes, such as nodes 0, 1, 2, 3 disclosed herein, via other electrical devices.

[0253] In one embodiment, the distance S is a target operating range suitable for maintaining accuracy of device operation and / or applicator output relative to an expected or baseline applicator output for a given set of input signals and / or powers. In one embodiment, S ranges from about 0 to about 2 inches. In one embodiment, S ranges from about 0 to about 6 inches. In one embodiment, S ranges from about 0 to about 12 inches. In one embodiment, S ranges from about 0 to about 24 inches. In one embodiment, the control node or nodes 444 include a radio frequency printed circuit board (RF PCB) stack disposed in a housing or other assembly, such as component 440b. In one embodiment, Figure 4C Each applicator depicted in is in electrical communication with one or more control nodes (such as nodes that are the same as or similar to node 444).

[0254] In one embodiment, it may be desirable to treat two or more sections or zones of a patient simultaneously in order to reduce the total amount of time that the treatment will take. Therefore, it is an advantage of the present disclosure to utilize RF to perform parallel treatment of different tissue areas in different parts of the body at the same time. In some cases, additional treatment zones may be treated in addition to these zones. In some embodiments, each tissue zone may be treated in an alternating order for a certain period of time or alternating number of iterations, with the first zone being active while the applicator delivers RF energy and the second zone being inactive, and vice versa. This approach may be used to the extent that this approach is most comfortable for the patient or where a particular treatment regimen would benefit from a rest period or alternating RF exposure during a given RF treatment.

[0255] Figure 4D A patient 445 is depicted undergoing RF-based tissue treatment in which multiple tissue areas are treated using multiple applicators positioned relative thereto. The applicators are typically conformable applicators that are adhered or otherwise bonded to the skin. In some embodiments, other applicators may be used. In more detail, Figure 4D A patient 445 is depicted undergoing RF-based tissue treatment, wherein multiple tissue regions are treated in two different sections or zones of his body, Zone A, Zone B.

[0256] Specifically, a plurality of RF applicators 450a, 450b, 450c, 450d, and 450e are used and placed in contact with the patient. Two supports, such as supports 455a and 455b, are also shown having extension arms 457a and 457b supporting distribution devices 460a and 460b. The benefits of this configuration support the above discussion of Figure 4C The multi-zone processing shown is typical. The use of separate distribution devices 460a, 460b in electrical communication with applications 450a, 450b, 450c, 450d and 450e via cables, such as cable 462, facilitates the use of thin conformable electrodes in a multi-zone processing setup.

[0257] While any suitable applicator may be used, a conformable applicator is preferred. Figure 4C The multi-zone process shown is typical. Considering that the conformal applicator can be a thin flexible sheet or stack of layers, it is advantageous to separate the drive electronics so that they are located near the electrode array of such an applicator. With this in mind, Figure 4DAn embodiment has a conformal applicator having an electrode array arranged as shown, with drive electronics and other electronic components (such as one or more control nodes) provided in distribution devices 460a, 460b as shown.

[0258] Each distribution device 460a, 460b can include multiple arms having connection ports or directly connected to a transmission cable 462 that connects each arm of the distribution device to a given applicator. As shown, each distribution device has four arms, three of which are visible in the figure, and a fourth is positioned on the other side of the device opposite the center arm of each such device. The drive electronics in the distribution device transmit power and control signals to the electrode array of each applicator connected thereto and receive impedance data when performing impedance mapping relative to the various tissue treatment areas in Zones A and B.

[0259] Applicators 450a, 450b are positioned in a first treatment zone, Zone A, which includes the upper back and triceps area of ​​each arm, while applicators 450c, 450d, and 450e are positioned in a second treatment zone, Zone B, which includes the lower back and upper back of each thigh. Figure 4D The simultaneous or alternating treatment zones depicted in the figure facilitate the use of a conformal applicator that remains fixed relative to the target treatment area. These configurations can reduce the number of office visits and improve treatment outcomes by placing the conformal applicator over a specific tissue area. Some additional benefits of selective tissue targeting are discussed in more detail below in the context of RF energy selection.

[0260] As described above, short duration, relatively high magnitude RF energy can be used to "selectively target" tissues, such as fibrotic or connective tissue, diaphragms, or even blood or lymphatic vessels, which are structures present in all tissues and present relatively low electrical impedance compared to bulk tissue. According to various aspects of the present teachings, the impedance of a measured tissue region (including diaphragms) can be monitored and tracked during the application of RF pulses to determine changes in tissue composition in real time. For example, during the transmission of an RF pulse, current, voltage, and their phase relationship can be monitored in order to calculate the impedance of the tissue to which the RF energy is being applied. Now referring to Figure 5A In various aspects of the present teachings, impedance tracking of individual electrodes and / or the average impedance of the array electrodes during treatment can also be used to determine when to terminate treatment. As described above, for example, certain tissue types (e.g., fibrotic structures such as septa) typically exhibit lower impedance relative to adipose tissue. Therefore, according to certain aspects of the present teachings, monitoring of impedance can indicate when those low-impedance tissues have been sufficiently altered by the application of RF energy to indicate that the desired result has been achieved.

[0261] Figure 5AThe impedance map of the tissue during application of an exemplary RF signal 205 intended to provide a 500 ms pulse of high power RF energy, beginning at time 210B as shown at the top of the figure. For example, before initiating the pulse at time 210B, a sub-treatment threshold low RF power between the active electrode and the drain pad (or another active electrode on a second applicator) can be used to determine whether the Figure 5B The impedance of native tissue is schematically depicted. As discussed elsewhere herein, this relatively low impedance detected at time 210B will be understood to represent the propagation through Figure 5B RF energy to the untreated membrane 200 depicted in FIG. However, as Figure 5A and 5C As shown, the application of treatment RF energy after the initiation pulse at 210B causes a change in the impedance of the tissue during heating. For example, primarily due to the RF energy propagating within the diaphragm 200 between the initiation pulse at 210B and the initiation pulse at time point 210C (e.g., approximately 300 ms), the impedance measurements generally indicate that as the diaphragm heats and / or contracts, the impedance changes, such as by decreasing Figure 5C As schematically shown by the length of the diaphragm 210, the impedance of the tissue between the active electrode and the drain pad (or another active electrode on the second applicator) decreases. For example, in some aspects, a small change in impedance (e.g., a measured impedance drop of a discernible amount, about 3%, greater than 3%, about 3% to about 20%, or about 10%) during the RF energy pulse can indicate an increase in temperature in the diaphragm and / or indicate shrinkage and / or tightening of the diaphragm. As heat continues to accumulate in the diaphragm, the impedance suddenly increases rapidly between times 210C and 210D, as shown in FIG. Figure 5A shown.

[0262] Without being bound by any particular theory, this dramatic increase in impedance can be attributed to a dramatic change in the structure and / or composition of the tissue between the active electrode and the drain pad (or another active electrode on the second applicator). Figure 5D , this impedance rise can be attributed to the rupture of the septum caused by the RF energy, such that the low impedance path through the bulk tissue no longer exists, and the detected impedance increases to a higher level consistent with the bulk tissue (including high impedance adipose tissue). For example, in some aspects, after the initial decrease in impedance described above, a sharp increase in impedance during the RF energy pulse (e.g., a rapid increase in measured impedance by a discernible amount of about 3%, greater than 3%, about 3% to about 20%, about 10%, greater than 10%, or greater than 20%) can indicate a large temperature increase in the septum causing coagulation, denaturation, rupture, and / or destruction of the septum. As Figure 6AAs shown, after time 210D (e.g., approximately 400 ms), the detected impedance remains relatively level despite the continued administration of the exemplary RF pulse for its entire 500 ms duration (time 210E). Thus, it will be appreciated in accordance with the present teachings that by monitoring the impedance of the tissue during treatment, it can be determined whether the desired results have been achieved, and in some aspects, such changes can be used to determine the endpoint of administration (termination of treatment) and / or to adjust treatment parameters (e.g., increase power, increase pulse width, administer additional RF pulses). For example, when such a sharp increase in impedance is observed, treatment can be terminated at time 210D (e.g., by ending the pulse or series of pulses).

[0263] In various aspects, the sampling rate of the monitored impedance can be selected (e.g., Figure 5A The sampling rate of the monitoring may include any of a plurality of sampling times and frequencies during the pulse transmission. For example, the sampling rate of the monitoring may occur approximately 5 times, approximately 10 times, approximately 100 times, or approximately 1000 times during the RF pulse transmission.

[0264] The above description of impedance tracking during RF treatment can be used with pulsed single-electrode applicators (e.g., Figure 1A Applicator 130d) or an applicator with multiple electrodes (e.g., Figure 1A 、 1B In various aspects of the applicator comprising an array of individually addressable electrodes, one electrode 562 (or electrode cluster) of the array 560a on one applicator 530a is used with one electrode 562 (or electrode cluster) of the array 560b on a second applicator 530b (e.g., Figure 5E After there is sufficient impedance change in the tissue between the two applicators (as shown), similar treatments can then be performed using different combinations of electrodes 562 between the two applicators (or between an applicator and the drain pad) to treat different tissue and septal areas under the electrode array, such as Figure 5F shown.

[0265] In various aspects, electrode monitoring can also be provided to monitor the electrical condition of each electrode to meet an open circuit (no contact) condition in order to determine whether the electrode is in sufficient contact with the tissue. In these aspects, uniform attachment of the applicator and any drift in the electrical condition from the point of application (e.g., start of treatment) to the end of the procedure (e.g., gel adhesive dehydration) can be optimized to avoid misinterpretation of tissue impedance conditions. Because the electrode array can be composed of many individual electrodes and the impedance of each array position can be continuously monitored, a robust method for automatic monitoring of the electrode array can be provided.

[0266] Patient surface temperature feedback:Ambient feedback of patient surface temperature for RF uniformity compensation.

[0267] As described above, in accordance with various aspects of the present teachings, various detection and / or feedback mechanisms are contemplated to help provide improved RF treatment. For example, as discussed above, surface temperature feedback can be used alone or in combination with impedance mapping to assist in achieving RF treatment uniformity. For example, by detecting temperature differences at various portions of the tissue surface adjacent to the target area, the distribution of RF power delivered through each individual electrode in the electrode array (or the total treatment time or duty cycle) can be controlled or modified to adjust for and / or prevent heat accumulation in non-target areas (e.g., outside the applicator perimeter) or non-uniformity in the treatment zone, whether due to anatomical variations or variations in tissue layer thickness.

[0268] In an exemplary aspect, the temperature of the patient's skin surface in an area around the perimeter of the applicator electrode array can be monitored by IR sensors, thermocouples, etc. (as non-limiting examples) to identify uneven heating of skin surface areas adjacent to the intended treatment area. Based on these signals (alone or in combination with impedance mapping), the controller (including Figure 1A The microprocessor and algorithms in the RF system can provide correction factors to the RF power set points of each electrode to optimize treatment uniformity, homogeneity, and placement of the treatment zone.

[0269] For example, as discussed above, dermatochalasis and other treatments requiring substantial heating may require a "time at temperature" specific to a given tissue type, anatomical region, and desired treatment endpoint. As a non-limiting example, a suitable treatment temperature range may be approximately 42-47°C, and a suitable total treatment time range may be approximately 10-35 minutes. However, dosimetry methods using a total energy and volume approach may not identify widespread variations in patient perfusion (e.g., cooling effects) or variations in heat capacity of different tissue types (e.g., nearby or adjacent bones, viscera, and / or thick fat layers may all cause variations in temperature deposition when exposed to a fixed dose of joules / volume).

[0270] Predictable RF uniformity is important for the effectiveness and safety of applying RF treatments and can be a problem if the fat layer is non-uniform. However, applying uniform RF energy (e.g., 1 MHz) through the patient's skin and then into deeper tissue (e.g., the fat layer) is complicated by the various tissue types and different impedance variations. For example, as discussed above, fibrous structures and other connective tissues have a lower impedance to RF energy than fat tissue. In addition, the tissue layers beneath the fat layer (including muscle, large blood vessels, etc.) also have a much lower impedance than fat. Therefore, as opposed to fat tissue, RF energy will preferentially travel along these low impedance paths, causing the RF energy to tend to preferentially heat (at least initially) these low impedance tissues before diffusing into adjacent fat cells.

[0271] In particular, an RF treatment applicator placed on the surface of tissue directly above a fat layer of uneven thickness (e.g., one side of the applicator is above a 20 mm thick fat layer, while the opposite side of the applicator is above a 40 mm thick fat layer) can cause uneven heat distribution and / or treatment of non-target tissue. That is, because fat cells have a higher impedance relative to deeper muscle tissue, for example, RF energy delivered uniformly at the surface will "drift" toward the direction of least impedance (in this case, toward the muscle). Because RF energy generally travels through a high-impedance fat layer via the shortest path length to enter deeper tissue, the RF energy will tend to be delivered through a 20 mm thick fat layer, causing the temperature on that side of the applicator to increase more than on the side of the applicator with a 40 mm thick fat layer. This can cause the "treatment zone" (the area of ​​tissue exposed to the increased temperature) to drift toward the shallowest fat layer, causing the actual treatment zone to shift from under the applicator toward the side of the shallowest fat layer, an undesirable and somewhat difficult to predict effect.

[0272] refer to Figure 6A -E can further understand the effects of such non-uniform energy distribution and the benefits provided by various aspects of the present teachings. First, refer to Figure 6A , depicts the temperature profile of a fat layer of relatively uniform thickness of 40 mm during treatment, where each of the multiple electrodes delivers the same RF power. Figure 6A , the left vertical axis is the distance from the patient's skin surface (e.g., the depth below the skin surface) measured in meters, while the horizontal axis is the distance from the center of the applicator measured in meters. The right vertical axis is the temperature in degrees Celsius. As shown, uniformity of the temperature concentrated in the treatment zone can be observed, where the treatment zone is symmetrical and located immediately below the RF energy applicator.

[0273] on the other hand, Figure 6B Shown in Figure 6ATemperature profile of the non-uniform fat layer during the same RF treatment. In particular, Figure 6B The left side shows a fat layer about 40mm thick, while Figure 6B There is a fat layer about 20 mm thick on the right side of the patient. Asymmetry and drift of the temperature of the treatment area away from the thicker fat layer can be observed, so that the treatment area is not located immediately below the RF energy applicator (towards the Figure 6B The thinner fat layer on the right side is displaced), which may be an undesirable result. Figure 6C This treatment zone drift is depicted schematically, with the vertical axis representing depth and the horizontal axis representing the distance parallel to the skin surface from the center of the applicator (measured in meters). As shown, the zone exhibiting the target treatment temperature is asymmetric and shifted away from the center of the applicator.

[0274] Figure 6D Describes the Figure 6B and 6C An exemplary temperature curve of a simulated tissue surface, with the left vertical axis being the temperature in degrees Celsius and the horizontal axis being the distance from the center of the applicator (along the skin surface) measured in meters. Figure 6D As shown, two heated lobes are observed, one on each side of the perimeter of the applicator's cooling surface. In the case of a uniform fat layer thickness, these two lobes would be expected to be equal in size. However, in this case, due to the shallower fat layer, more RF energy is deposited toward the right side of the depicted treatment area, making the lobes asymmetrical. Therefore, correcting and / or preventing uneven treatment zones or drift of the treatment zone from beneath the applicator is an objective of the present disclosure.

[0275] In various aspects as discussed elsewhere herein, more uniform treatment can be achieved by delivering proportionally more RF energy to the thicker fat layer side of the applicator and proportionally less RF energy to the thinner fat layer side of the applicator. In this exemplary case, the electrode is an array of a plurality of independently switchable skin surface contact electrodes (e.g., 19 electrodes arranged in a hexagonal array for the depicted example). The electrode array can be electrically isolated from but thermally coupled to a water-cooled plate (e.g., as described in reference to FIG. Figure 2A and 3A (as discussed above). Switching the electrode array allows for uneven distribution of RF energy to the tissue, counteracting the tendency of the treatment zone to drift toward the thinnest fat layer. Specifically, drift can be prevented by increasing the RF power delivered to the thicker fat layer side of the applicator while simultaneously reducing the RF power of the individual electrodes switched to the thinner fat layer side of the applicator. This uneven applicator power approach forces the treatment zone to remain centered beneath the applicator, regardless of variations in tissue impedance and / or fat thickness.

[0276] Figure 6EShown compared to the uniform RF power input method provided on the left (as described above in conjunction with Figure 6C As shown in FIG, uniformity is improved on the right side due to the redistribution of RF power to provide non-uniform RF power input to compensate for the non-uniform fat layer. Figure 6E The left-hand image of produces an offset to the right of the highest temperature region, which is well beyond the dimensions of the applicator. Figure 6E The right hand image of provides a non-uniform RF applicator power input by which the power is adjusted to compensate for underlying tissue thickness variations (e.g., as determined by impedance mapping). According to various aspects of the present teachings, Figure 6E The right-hand image in depicts the highest temperature region, which is immediately adjacent to the dimensions of the applicator, and illustrates the ability of the adjusted system to cause tissue heating to occur beneath the applicator, regardless of changes in tissue impedance caused by the non-uniform fat layer. For example, each independently switched electrode can operate in a closed loop with respect to power. In addition, each electrode can be used as a discrete impedance detector by monitoring the delivered amperes, volts, phase angle, etc. This impedance information can be used to derive a "map" of the general tissue layer non-uniformity near the applicator in order to provide a starting RF applicator power correction term to the control system so that individual electrodes located over high impedance areas (e.g., over thicker fat layers) are "corrected" to add a compensatory increase in RF power. And when individual electrodes are located over areas of relatively low impedance, the RF power is "corrected" to produce a uniform heat treatment zone that remains centered under the applicator.

[0277] The tissue impedance mapping method described above is used to provide feedback to the control system for reallocating (adding positive and negative correction terms to the RF power command) the RF power delivered through each individual electrode with the goal of controlling the treatment to remain centered under the applicator within the desired treatment zone.

[0278] Furthermore, in the case of non-uniform tissue impedance or thickness (e.g., a fat layer), the resulting skin surface temperature near the applicator periphery can be asymmetric when a correction term is applied to the individual electrode powers or when an insufficient correction is applied. That is, the skin surface near the periphery of the applicator edge located on a thinner fat layer (having lower impedance) will tend to get hotter than the skin near the side of the applicator periphery located on a thicker fat layer (having higher impedance). Therefore, even when the electrode array is uncompensated or undercompensated in reallocating RF power to individual electrodes based on impedance mapping, monitoring of the increase in skin surface temperature near the applicator periphery can provide a useful control feedback mechanism to correct for asymmetry or drift in the intended treatment zone. In some aspects, separately monitoring the patient surface near the electrode periphery (a few millimeters from the edge of the cooled patient cooling block) can provide sufficient feedback to the control algorithm to reallocate or correct the RF power delivered to the individual electrodes so that the treatment zone is controlled to remain uniform and symmetrical relative to the center of the applicator (e.g., the treatment zone is centered under the applicator).

[0279] According to various aspects of the present teachings, the patient surface temperature outside of the perimeter of the actively cooled patient water cooling block and electrode array can therefore give an indication of tissue temperature located deeper (i.e., below the skin surface). For example, an asymmetry in the surface temperature around the perimeter of the applicator can indicate an asymmetry or drift in the resulting "treatment zone" (the zone of elevated tissue temperature that reaches the target temperature). Specifically, the individual electrodes closest to the applicator area with the highest skin surface temperature will be switched to reduce the RF power, while the other side of the applicator will be switched to increase the duty cycle of the applied RF power. For example, one side of a given electrode array that is overheating can be turned off (or its duty cycle reduced) in favor of another portion of the same array with a lower skin surface temperature. Therefore, the skin surface temperature around the perimeter of the applicator electrode array can serve as an indication that the RF power must be modified so that the temperature increase on the skin surface can be controlled to remain consistent and uniform around the perimeter of the applicator.

[0280] The uniformity of the skin surface temperature increase is maintained by monitoring the temperature around the periphery of the electrode array and / or by monitoring the impedance of individual electrodes in the array, either individually or in combination, so that feedback can be provided to the control system with the goal of homogenizing and centering the treatment area beneath the center of the applicator electrode array.

[0281] Impedance measurement and temperature feedback of subcutaneous tissue

[0282] One of the main goals of hyperthermia treatments, including those used for fat destruction and tissue tightening, is to elevate the temperature of tissue beneath the superficial surface of the skin to about 39°C to about 47°C, about 39°C to about 44°C, about 41°C to about 42°C, or about 42-47°C, while maintaining the temperature of the skin surface at a normothermic temperature of about 35°C or less. However, the temperature at a certain depth is generally unknown or requires invasive methods to monitor the temperature below the surface, making it difficult to directly infer the subcutaneous temperature from the surface temperature due to active cooling of the tissue surface. Therefore, the patient's sensation is often used to determine the appropriate heating rate or dose.

[0283] However, applicants have discovered that measured impedance and subcutaneous temperature can be closely correlated. As discussed above, the impedance of the area beneath the electrode array can be mapped to determine where more or less energy should be deposited to compensate for anatomical variations. By observing the impedance mapping during treatment, it was observed that there was a strong correlation between the impedance and the temperature of the subsurface tissue, which can be further applied to a closed-loop feedback mechanism so that the system can determine the temperature of the subcutaneous volume beneath a specific electrode, electrode cluster, or electrode array. It should also be understood that one advantage of knowing the temperature beneath the tissue surface is that treatment temperature variations can be minimized by compensating for changes in perfusion or regional anatomical hot spots that may determine overall sensation.

[0284] The figures described below depict exemplary aspects of the identified correlation between impedance and subcutaneous tissue temperature. Figure 7A As shown, during an exemplary RF treatment, the tissue temperature at a depth of 1.5 cm is determined by an invasive temperature sensor (a fluorophore-tipped optical fiber, which is not affected by RF like a traditional thermocouple). Power in watts is on the vertical axis on the right, the resulting temperature in degrees Celsius is on the vertical axis on the left, and treatment time is on the horizontal axis. As shown, the graph shows a ramp-up phase as the tissue temperature rises over the first few minutes of treatment, after which the RF power is reduced to maintain an approximate plateau of approximately 45°C. That is, the target tissue can be raised to a treatment temperature range (e.g., 42-47°C) during an initial heating or build phase, wherein the RF power (or duty cycle) is increased, after which the RF power (or its duty cycle) can be reduced to maintain the target tissue within the desired treatment temperature range (e.g., at its plateau of approximately 45°C).

[0285] exist Figure 7B The same exposure is plotted in another way in . Substituting temperature, Figure 7B The total impedance of the combined electrode array is plotted against exposure time for two different cooling temperatures, 15°C as shown by squares and 28°C as shown by diamonds. Based on this figure and in accordance with the present teachings, one skilled in the art will understand the clear relationship between the ramp and hold phases, where impedance is proportional to Figure 7AThose skilled in the art will therefore appreciate, based on the present teachings, that this observation can be used to determine absolute or relative calibration based on impedance measurements (e.g., relative to a starting point and recorded increments), which helps maintain consistency and effectiveness of RF treatment.

[0286] Figure 7B The graph also shows that the detected impedance generally reflects the offset between the different cooling settings (e.g., lower temperatures are associated with higher impedance). In this case, 15°C cooled water (shown as squares) provides more conductive cooling to the patient surface and adjacent deeper tissue layers than 28°C cooled water (shown as diamonds), resulting in a different offset or different nominal starting impedance. Without being bound by any particular theory, this phenomenon may be because the cooler tissue constricts blood vessels, resulting in a higher impedance for the cooler 15°C surface temperature. It can be seen that the electrode starting impedance (resistance) is higher for tissue in the 15°C water-cooled area than for tissue in the less cooled area (28°C cooled water), with the impedance difference being approximately 19-20 ohms. As discussed above, the patient impedance is inversely proportional to the temperature increase at a given depth, such that when comparing Figure 7A -B, those skilled in the art will understand in accordance with the present teachings that an increase in temperature of approximately 11-12°C at a depth of 1.5 cm corresponds to a decrease in patient tissue resistance of approximately 19-20 ohms. In addition, similar increases or decreases in patient tissue resistance (impedance) are observed in the 28°C and 15°C curves, indicating that the temperatures at the depths are similar. In view of this relationship, the impedance increases that occur during treatment can be effectively used in accordance with various aspects of the present teachings, for example, to determine the treatment endpoint and help maintain a consistent treatment temperature at a certain depth, thereby reducing the side effects of over-treatment and improving therapeutic efficacy. Therefore, in accordance with various aspects of the present teachings, a control scheme can be provided in which changes in patient tissue impedance can be monitored during treatment, and in which the energy transmitted to the patient is reduced or increased to maintain, for example, a target decrease in resistance (e.g., approximately 19-20 ohms). That is, the RF signal can be adjusted or regulated by a closed-loop algorithm to bring the impedance close to the target value and then maintain the impedance at the target value.

[0287] Multiple processing pads

[0288] According to various aspects of the present teachings, multiple treatment pads can be used. In the simplest form of a treatment pad, one array can serve as the "source" while the other serves as the "return." Both electrode arrays can cover the same area, and the clinical endpoints for both areas can be the same. In this case, there is no return electrode where the current uselessly completes the circuit, but rather the return current provides the exact same tissue heating as the source current. This approach can also support multiple electrode arrays, such as two or more electrode arrays or three or more electrode arrays.

[0289] Running multiple processing pads

[0290] In some aspects, as this article combines Figure 1A and 1E As discussed, two or more treatment pads (e.g., treatment applicators having electrode arrays) can be operated in a bipolar or hybrid configuration. In embodiments where there can be two or more treatment applicators, each can have an active electrode array that is provided with its own DC and RF drive circuits that can be independently controllable, including voltage and phase.

[0291] Two or more treatment applicators each have an RF drive circuit operating at the same RF frequency, however, each treatment applicator operates at a different phase (e.g., the phases are not necessarily the same). In some aspects, for two or more treatment applicators, all RF transformer secondaries (e.g., the "output" side of each transformer connected to the subject or patient) are connected together and referenced to a single drain electrode.

[0292] In one embodiment, only one active electrode array is used and the drain electrode serves as the return electrode. In this case, all RF current flows through the active electrode array and the drain (return) electrode.

[0293] In another embodiment, two or more active electrode arrays are used and a minimum amount of current flows through the drain electrode. The RF applied to each of the two or more active electrodes can be controlled in voltage and / or phase to achieve all or nearly all of the current flowing between and among the two or more active electrode arrays, with a minimum amount of current flowing through the drain electrode. This method can be used for any number of active electrode arrays greater than one, including odd or even numbers of active electrode arrays. For example, it is feasible to use phasing to allow three active electrode arrays to share all of the current between the three active electrode arrays, with a minimum amount of current flowing through the drain electrode.

[0294] In the case of multiple active electrode arrays, the drain electrode can serve two purposes: (1) to monitor the voltage between the secondary of the RF transformer (e.g., connected to the output side of each transformer of the subject or patient), thereby monitoring body voltage; and / or (2) to act as a "dump" or "drain" for a small amount of RF energy in the event that the anatomical structure underlying all or part of the active RF electrode requires less current than another one of the two or more active RF electrode arrays. In such a case, phasing can be arranged to divert some current to the drain electrode so as to reduce some of the current flowing through one of the multiple active RF electrodes in the array, thereby achieving uniform tissue heating or uniform tissue temperature regardless of the different anatomical structures.

[0295] Active electrode phasing can also be adjusted to compensate for various anatomical placements of the active electrodes. For example, in the case of four electrodes, if two are placed adjacent to each other on the body, the active electrodes can be phased so that the two adjacent electrodes are in phase and do not pass current through the skin between them, but instead act as one large electrode array, effectively heating the desired tissue. Phase control of the signals transmitted to the electrodes can be used to effectively control energy, current, RF signal, power delivery, and other parameters within or near a given target treatment area to facilitate target tissue treatment or other objectives of a given treatment.

[0296] It will be appreciated that this exemplary architecture can therefore provide for the use of any number of active electrode arrays to achieve large area tissue heating without being limited by the size of the return electrode, and also with greater flexibility regarding the placement of the active electrodes.

[0297] In one exemplary configuration, three treatment applicators may be connected in a wye or star configuration, wherein each applicator is provided with an RF output that is 120 degrees out of phase with each other, and wherein the sum of the RF current on the neutral pad (e.g., the drain electrode or return electrode) is substantially zero, thereby causing a minimum amount of current to flow through the drain electrode. Other exemplary configurations would include an even number of applicators (e.g., two or four treatment applicators), and wherein the phase angle of the RF power signal to each applicator is 180 degrees out of phase. In the case of four applicators, two of the four applicators, for example, may have a phase angle of 0 degrees, while the other two may have a phase angle of 180 degrees, wherein the RF power returned via the drain electrode will be substantially zero or sum to zero.

[0298] By providing an equal number of electrodes with phase angles of 0 and 180 degrees, any even number of applicators can be used, resulting in essentially zero neutral return current or minimal return current flowing through the return pad. In the case of an odd number of applicators, multiples of three can be used, resulting in essentially zero neutral return current or minimal return current by delivering a phase angle of 120 degrees, and wherein the number of applicators operating at each phase angle is equal relative to each node. For example, in the case of six applicators, an RF signal with a phase angle of 0 can be applied to two applicators, a different RF signal with a phase angle of 120 degrees can be applied to another two applicators, and a different RF signal with a phase angle of 240 degrees can be applied to the remaining two applicators.

[0299] In the case of an odd number of applicators that is not divisible by 3 (e.g., 5, 7, 11, 13, etc.), the return current will not sum to substantially zero. However, the neutral return current will be substantially equal to the RF power provided to a single applicator, and the remaining applicators will all cancel each other out, so that their sum is substantially zero return current.

[0300] For this case of an odd number of applicators not divisible by 3, there can be two equal groups that are 180 degrees out of phase with each other, and the remaining electrodes can be operated at any phase angle. Alternatively, the number of applicators can be divided into three groups, each group operating 120 degrees out of phase, and the remaining ungrouped applicators operating at any phase angle. In both examples (two groups 180 degrees out of phase, or three groups 120 degrees out of phase), the sum of all applicators is essentially zero return current, except for a single applicator, whose sum will not be zero, and in which case no matter how many odd number of applicators not divisible by 3 are used, the neutral return current will be essentially the same as that of a single applicator.

[0301] The utility of these methods where the neutral return current sums to zero (except for one treatment applicator) is that any number of treatment applicators can be used without worrying about overheating the return pads. As a result, large areas of the body can be treated / covered with treatment applicators simultaneously while only requiring the use of a single return pad. Alternatively, one may choose to use multiple return pads. In this case, the size of the individual applicators would be increased because the return current (essentially corresponding to only one applicator as described above) would be distributed among the multiple return pads. This can allow the treatment applicator size and the number of treatment applicators / electrode arrays to be proportionally adjusted to appropriately address a given treatment area. In these examples, the essentially zero assumption is that the energy delivered to each treatment applicator is essentially equal (e.g., essentially uniform underlying anatomy). However, where slight variations in the RF power delivered to each treatment applicator or electrode array are observed, a minimal amount of return current may flow to the drain (return) electrode due to variations in the anatomy underlying each applicator or electrode array.

[0302] Referring now to Figures 7C1-8, an exemplary electronic device of a system 700 according to various aspects of the present teachings is depicted, wherein illustration 700' represents a block diagram of a single electrode array / applicator. Element 720 represents a neutral electrode return circuit. Elements 730, 740, 750, 760 represent four separate RF amplifiers (e.g., RF energy sources) that are connected in a Y-configuration and can operate at any phase angle relative to each other. Each RF amplifier is connected to a single electrode array / treatment applicator. For example, RF amplifier 730 is connected to electrode array 700'. As shown, an adjustable 48V isolated DC power supply 770 provides power to the four RF power amplifiers. A block diagram of a system controller 780 determines the operating level and phase angle at which each RF amplifier operates. Isolated communication circuits 785 connect each applicator to the system controller 780. The applicator / electrode array controller 790 switches the individual electrodes within a single array and also monitors the voltage, current, and phase of the individual electrodes within a single array, and this electrical feedback is used to determine the impedance of each individual electrode within the electrode array / applicator. As discussed elsewhere herein, the controller 790 can adjust the duty cycle of the RF energy applied to each individual electrode within the electrode array so as to enable uniform deposition of thermal energy in the tissue underlying the array.

[0303] In some exemplary aspects, a system for treating patient tissue can include two or more treatment applicators that are used to treat a single area (e.g., abdomen) of the patient tissue or to treat different areas (e.g., upper arm and thigh) of the patient tissue. In order to be able to perform two types of treatment, each treatment applicator can have its own individually controllable RF energy source, and each RF energy source can operate at the same fundamental frequency (e.g., at a single fundamental frequency), but the phase and amplitude of each of the two or more RF energy sources are controllable. Specifically, the phase and amplitude of each of the two or more RF energy sources can be controlled relative to each other so that current can be shared between the two or more applicators. In various aspects, this ability to share current between two or more applicators can enable the applicator to be flexibly placed on the subject's body, so that two or more applicators can be placed in the same treatment area (e.g., abdomen) or in two different treatment areas (e.g., one applicator is placed on the upper arm, and the other applicator is placed on the thigh) so that each different treatment area can deliver an appropriate amount of RF energy thereto. For example, in an embodiment where one applicator is placed on the upper arm, any excess current flowing to the upper arm that is unnecessary for treating the target tissue can be shared (e.g., diverted) with another applicator to treat the thigh tissue, which is an area with higher tissue density than the arm. In some embodiments, a return electrode or drain electrode can be used in addition. In various aspects, two or more treatment applicators can each have a plurality of treatment electrodes (e.g., a treatment electrode array) that are configured to be placed in contact with and deliver RF energy to a tissue surface of a patient, wherein the plurality of treatment electrodes includes at least two individually addressable treatment electrodes to which an RF signal can be applied.

[0304] drain pad

[0305] For example, a drain pad can be used to balance two process pads. If multiple arrays are used, one may heat up faster than the other, requiring some of the RF energy to be drained to a third, non-process return electrode.

[0306] Water temperature changes

[0307] The change in water temperature can be induced by changing the coolant set point, thereby changing the heating profile of the skin. Cooler temperatures will cause the heated area to be deeper, while conversely, heating the water will cause the area to be closer to the dermis for tightening. In various aspects, as discussed elsewhere herein, the circulating water can be configured to maintain the skin temperature within a range of approximately 15-35°C during treatment, with adjustments made to affect sensation / patient comfort and / or control the depth of the heated zone.

[0308] RF regulation

[0309] Adjustment of RF power can be used to improve sensation (e.g., reduce pain in the patient). For example, the temperature increase treatment can be limited to the target tissue while keeping the temperature of the tissue at a certain depth above the target tissue (e.g., epidermal and / or dermal tissue) below the damage threshold (i.e., below about 46-47°C). For example, RF treatment parameters (such as delivery mode, power, pulse duration, etc.) can be adjusted during the treatment time, and in some aspects, by taking into account the cooling rate of the skin surface, an optimized temperature distribution / gradient in the target tissue (e.g., tissue near or below the dermis / hypodermis junction, such as hypodermis) can be achieved during the treatment.

[0310] Electrode sampling

[0311] Sampling of each individual electrode for control purposes can preferably be performed at a frequency that avoids muscle fatigue. While the fundamental frequency is between 0.5-4 MHz (lower frequencies may be preferred to reduce crosstalk between electrodes), the control loop can operate at frequencies close to 100 Hz. Adjustments to the duty cycle of each electrode should be staggered to reduce the effects of fatigue.

[0312] Exemplary Treatment of Mucosal Tissue

[0313] As described above, systems and methods according to various aspects of the present teachings can also be used to provide treatment to various internal tissues by applying RF energy to mucosal tissue surfaces via water-cooled treatment electrodes or electrode arrays operating in monopolar or bipolar mode, from which the RF energy propagates to deeper tissue layers. In these aspects, for example, tissue remodeling can be achieved by heat generated within the subtissue surface region by tissue-penetrating RF energy, while cooling can protect the overlying tissue. In some embodiments, the RF electrode arrays used to treat mucosal tissue are uncooled. Although described below with reference to exemplary treatments of the vagina (e.g., vaginal laxity, rejuvenation, urinary incontinence, and other urogenital conditions), it should be understood that the present teachings can be adapted to provide desired treatments to other internal tissue surfaces (e.g., esophagus, oral cavity, fecal incontinence treatment, and digestive tract).

[0314] For example, stress urinary incontinence (SUI) is a condition characterized by the inability to prevent involuntary urination when the body is stressed, such as when coughing, sneezing, or exercising vigorously. It is often the result of weakened muscles around the bladder neck and urethra. SUI is commonly reported by postmenopausal women and is thought to be related to vaginal changes that occur during menopause, which weaken the vaginal walls or the muscles between the vaginal walls and the urethra. Although surgical intervention is well known and sometimes necessary in severe cases of vaginal laxity, surgery is often not advisable due to high cost, long recovery period, and potential side effects and complications. Therefore, non-surgical devices and methods for treating SUI and other urogenital conditions (especially in women) would meet a long-standing need.

[0315] In various aspects, methods and systems according to the present teachings can be used to treat SUI by applying RF energy to the vaginal wall to deliver a controlled amount of heat to reshape tissue (e.g., the anterior vaginal wall). The tissue can be the vaginal wall itself or tissue adjacent to the vagina near the urethra. For example, the target area for localized heating can be tissue between the vaginal wall and the middle urethra. In certain aspects, the target tissue can be heated to about 40°C to about 45°C, or about 41°C to about 43°C, or about 42°C (e.g., without surface cooling). The RF energy can be applied for a period of time, preferably less than 30 minutes, or less than 10 minutes, or in some cases less than 5 minutes. For example, RF energy can be applied for about one minute to reach the desired temperature in the target tissue area and continued to be applied to maintain the desired temperature for about 5 minutes. Thereafter, the heat source can be deactivated, and the treatment probe can be allowed to cool and removed from the vagina. In some cases, the entire procedure can be completed in less than 10 minutes. Alternatively, if surface cooling of mucosal tissue (e.g., vaginal tissue) is utilized, the tissue may be heated to a temperature above about 40°C to about 45°C, such as about 40°C to about 70°C, or about 45°C to about 60°C.

[0316] In certain aspects, the method can include the step of applying RF energy to the anterior vaginal wall to a depth of about 2 to 9 cm, preferably about 5 to 8 cm, or more specifically about 7 cm beyond the surface of the outer vaginal wall. In such embodiments, the anterior portion includes about 120 degrees of the vaginal wall closest to the urethra, for example, about 10 to 2 o'clock, 11 to 1 o'clock, 11:30 to 12:30, 12 o'clock, which is defined by the portion of the vaginal wall closest to the urethra.

[0317] In some aspects, it may be desirable to heat the entire target volume uniformly. As discussed elsewhere herein, various methods of ensuring uniform heating are described by varying the power delivered by individual electrodes. However, in some aspects, the methods of the present disclosure may also include using an array of electrodes to deliver heat to multiple tissue sites within the target area. This staged heating creates a lattice of hyperthermic islets, each of which is surrounded by relatively unaffected tissue. This "staged" treatment may be an ideal approach to tissue remodeling because the damage occurs within smaller sub-volumes or islets within the larger volume being treated. Because the resulting islets are surrounded by adjacent healthy tissue, which is largely undamaged, the healing process can be thorough and rapid.

[0318] Devices and methods for treating female urogenital conditions, such as urinary incontinence, particularly stress incontinence, are disclosed to reshape tissue in the anterior region of the vaginal wall and / or the muscles adjacent to the vaginal wall near the urethra.

[0319] The device can include a probe suitable for insertion into the vagina, the probe having a surface configured to apply heat to the anterior vaginal wall. In certain embodiments, the probe can be in the form of an elongated tube or rod with one or more treatment pads (e.g., an RF energy radiating electrode array) to deliver energy to tissue in contact with or near the probe. As previously described, each electrode in the array can be individually addressable and activated. The independently programmable electrodes in the array not only allow for customized treatment, but also can be used as sensors when inactive, thereby allowing control of the energy applied to achieve the desired heating pattern and uniformity of treatment within the target area, regardless of how the patient's underlying tissue electrical impedance or anatomical structure changes.

[0320] The probe can also include one or more temperature sensors to monitor the temperature of the vaginal wall surface and / or the target tissue. For example, the temperature sensor can be a thermistor or an infrared (IR) sensor that is configured to detect the blackbody radiation emitted by the heated tissue. Alternatively, temperature monitoring can be achieved by one or more electrodes used as impedance measurement electrodes. The application describes the relationship between impedance and temperature. The probe can also include a cooling pad to avoid overheating of the vaginal wall surface, thereby allowing heat to be delivered primarily to the target tissue area under the surface.

[0321] In some embodiments, the probe can include an array of pads or electrodes that can be programmed so that a subset of the array assembly can be activated to deliver heat to a specific area or in a specific pattern. For example, RF electrodes can be distributed over all or part of the probe's surface to heat the entire vaginal vault or a portion of the vaginal wall. Multiple electrodes allow not only monopolar treatment (characterized by an energy path from at least one electrode to a remotely located return pad) but also bipolar treatment (where energy flows between electrodes). In some embodiments, multiple electrodes can also be used to monitor tissue impedance (or simply resistance) in order to map the underlying tissue and / or further control the procedure. For example, adjusting the power to individual electrodes based on tissue impedance mapping can be used to homogenize the temperature increase across all treated areas. Controlling the output power of individual electrodes (e.g., via gate duty cycle) also allows the clinician to achieve a controlled and consistent tissue temperature increase across all treated tissues. This is particularly useful for devices that are fixed to an anatomical structure, activated, and then monitored only by a physician or staff member.

[0322] In certain embodiments, the probe may further include one or more securing devices. For example, a locking sleeve or sheath may be provided that can be inserted into the vagina before the probe can be used to secure the probe in the desired orientation and at a depth for treatment. The probe may further include one or more expandable elements that can expand after the probe is inserted to force the energy delivery element of the probe into proper contact with the anterior vaginal wall. The devices disclosed herein may be handheld or computer-guided. The probe may include markings to indicate penetration depth.

[0323] The present teachings also include systems comprising these devices, including, for example, controllers, power supplies, coolant reservoirs, monitors, and alarms, all or some of which may be incorporated into a console that provides a graphical user interface and displays various parameters. The system may also include imaging elements, either within the probe itself or partially within the probe, and used in conjunction with an auxiliary transurethral catheter to help identify the target tissue area. Alternatively, the probe may be used in conjunction with a separate imaging system, such as an ultrasound, X-ray, or fluoroscopic imager.

[0324] In other aspects, the devices and methods disclosed herein can be used to treat other genitourinary conditions by delivering controlled patterns of heat or RF energy to other areas of the vagina. One or more embodiments of the present disclosure can further be used to generally restore vaginal tissue and provide relief from various genitourinary syndromes of menopause (GSM).

[0325] It is believed that the proximity of the urethra and vagina may affect the improvement of SUI symptoms. Without being bound by any particular theory, it is further believed that heating of the vaginal wall and adjacent tissues between the vagina and urethra induces tissue remodeling through contraction, collagen regeneration, weakening, or a combination thereof of the target tissue, resulting in improvement of urine leakage symptoms.

[0326] Now refer to Figure 8 , schematically depicts an exemplary system 800 according to various aspects of the present teachings. As shown, the system 800 includes a console 810 that houses an RF generator and other electronic components (e.g., one or more microprocessors) and provides a display 832 of, for example, operating parameters. In one embodiment, the RF generator is designed to incorporate one or more features described herein with respect to node 1. In various embodiments, node 1 can be disposed in or near the console 810. The display 832 can be, for example, a touch-sensitive screen providing a graphical user interface (GUI) and / or the console 810 can provide separate user controls 811. As described above, while some exemplary applicators are described herein as generally planar (rigid or flexible) electrode arrays, in some exemplary aspects, the applicator can be configured to be inserted into a patient's body (e.g., through a lumen or natural body orifice) to apply RF energy to a mucosal tissue surface (e.g., vaginal wall, esophageal lining). For example, as Figure 8 As shown, the applicator can include a generally tubular probe 830 (e.g., a wand-shaped applicator) that is sized and shaped to be inserted into the vagina or esophagus for RF treatment thereof. The console 810 can be connected to the intelligent temperature-controlled probe 830 via a cable or umbilical cable 833, for example, for delivering RF energy from a generator disposed within the console 810 to the probe 830. In some aspects, the console 810 can also house a coolant source to provide circulating coolant to the applicator probe 830 via the cable or umbilical cable 833, as discussed elsewhere herein. It should be understood that in some aspects, the probe 830 can instead be wireless and contain its own RF generator, electronics, cooling, and power supply (e.g., a rechargeable battery).

[0327] like Figure 8 As shown, by way of non-limiting example, a probe 830 may be used for tissue heating and may include an array 860 of electrodes 862 ranging from two to several hundred electrodes, which may have a diameter of approximately 1 cm. 2A separate area of ​​the vagina. Those skilled in the art will understand from the discussion herein that the probe 830 can include a plurality of electrodes (or groups of electrodes or electrode arrays) that can be activated to apply RF energy to the target tissue in a monopolar or bipolar mode. For example, in some aspects, one electrode or group of electrodes of the probe 830 can represent an "active" electrode, while another electrode or group of electrodes can represent a neutral "return" electrode. Alternatively, it should be understood that a return pad can be placed on the skin surface (e.g., near the pubic area, on a portion of the patient's leg) during vaginal treatment to provide a path for the RF energy provided by the electrodes to return to the vaginal mucosal lining. In addition, as described below with respect to the separate probe 1130 Figure 11 As discussed in detail, the electrode array 1160a can be composed of needle tip electrodes 1162a that are configured to partially ablate the mucosa (e.g., 50 individual electrodes in a 5 x 5 mm area). Figure 8 , the probe 830 may also include one or more temperature sensors 842. In various aspects, the probe 830 may also include markings 844 to indicate the depth of its penetration into the vagina.

[0328] like Figure 9 As shown, the system 800 can also include a locking sleeve or sheath 850 (or introducer) that can be used to guide the procedure, for example, to ease insertion, provide alignment, and / or set depth based on bladder neck sounding using a Foley catheter or manual vaginal sounding. For example, the probe 830 can include a groove 851a to mate with a corresponding ridge 851b on the introducer 850, but other mating or locking mechanisms can be substituted as will be understood by those skilled in the art based on the teachings herein.

[0329] Now refer to Figure 10A -C, illustrates an exemplary method of processing SUI according to various aspects of the present teachings. In particular, Figure 10A A schematic diagram of the female urogenital tract is provided, including the uterus 802, vagina 804, bladder 806, and urethra 808. At the vaginal introitus, the urethra 808 and the vaginal wall are anatomically close. However, as the urethra 808 approaches the bladder neck, the urethra 808 separates from the vaginal wall. In various exemplary aspects, this is the area targeted for RF-based warming treatment (e.g., near the mid-urethra).

[0330] Now refer to Figure 10B, shows the insertion of a catheter 801 (e.g., a Foley catheter) after insertion into the urethra 808. As shown, the catheter 801 can be inserted into the urethra 808 until its distal end reaches the bladder 806, and then the balloon 803 can be inflated to stabilize and secure the catheter 801 in place. The full length of the urethra can be identified by its external orifice and its termination at the bladder neck. Identification of the bladder neck is a routine clinical practice, and is accomplished by inserting the catheter, inflating the balloon, and then retracting it until the balloon touches the neck.

[0331] In certain aspects, the catheter 801 may include one or more temperature sensors 805 disposed along its length and configured to measure temperature increases in, for example, the urethra 808 and / or to monitor the temperature of tissue distal to the tissue-electrode interface (e.g., at the target tissue to be heated). The catheter 801 may also be connected to Figure 8 The console 810 can be configured so that the current to the RF probe 830 can be controlled by monitoring impedance to ensure contact between the probe electrode 862 (e.g., a separately monitored electrode) and the vaginal wall, as discussed elsewhere herein.

[0332] As described above, in some aspects, the target area for RF-based warming treatment (e.g., near the mid-urethra) can be located approximately at the mid-urethra when the urethra 808 is separated (e.g., deviated) from the vaginal wall. In various exemplary aspects, the target area 809 can be tissue outside the vaginal wall located between the vagina 804 and the urethra 808. In order to heat this area via application of RF energy, the probe's electrode 862 should preferably be positioned in contact with the anterior wall of the vaginal fornix, such as Figure 10B shown.

[0333] Now refer to Figure 10C , depicts an exemplary procedure according to various aspects of the present teachings, in which a probe 830 is positioned in contact with a desired area of ​​the vaginal wall so that one or more electrodes 862 can heat the vaginal wall via application of RF thereto. It should be understood that, for example, if it is desired to heat a larger length or width of vaginal tissue with a less strenuous hand motion (or to automate the procedure), more than one electrode 862 can be used simultaneously to apply RF energy. In various exemplary aspects, the probe 830 can also include an inflatable balloon 840 to stabilize the probe 830 in contact with the vaginal wall surface. As discussed further herein, for example, the electrodes 862 can be connected to a common node (e.g., one or more electrode clusters) or can be individually controlled to deliver power only to those electrodes in contact with the vaginal wall. In various aspects, each of the plurality of electrodes 862 (or electrode groups 862) can be activated to apply RF energy to the target tissue in a monopolar or bipolar mode. Alternatively, it should be understood that a return pad (e.g., Figure 1C808 .

[0334] In some aspects, a hands-free setup may be preferred. For example, after probing the vagina and bladder neck, the practitioner can adjust the probe 830 to apply RF to the correct area along the urethra 808, secure the probe 830 in place with the balloon 840 or other means, and use feedback to confirm that the probe 830 (and its electrodes 862) are in contact to initiate the application of RF. According to various aspects of the present teachings, as discussed elsewhere herein, the probe 830 can then be operated to uniformly deposit RF energy, maintain a uniform desired temperature range in the target area, provide consistent dosimetry, and / or provide surface cooling.

[0335] For example, the probe 830 may further include a cooling mechanism 835, such as one or more cooling surfaces interspersed with electrodes 862, which cool the vaginal wall surface by circulating a coolant through the probe 830. Alternatively, in various aspects, cooling may be achieved by a thermoelectric (Peltier) device or by using a phase change material (e.g., ice) in thermal contact with the patient contact surface (e.g., via an electrode). As discussed elsewhere herein, controlling the temperature of the electrode-tissue interface may be used to control the depth of the target tissue. Cooling may alter the treatment target so that heating the target tissue is not limited by patient tolerance (e.g., within a range of about 40°C to about 45°C). For example, by cooling, the target temperature may be increased to a temperature in the range of about 40°C to about 70°C, or about 45°C to about 60°C.

[0336] Now refer to Figure 11, depicts another exemplary probe 1130 according to various aspects of the present teachings. As shown, probe 1130 can include multiple different electrodes 1162 disposed across the entire surface of probe 1130, as opposed to the anterior, distal region of the probe. As will be appreciated in light of the present teachings, advantages of this probe 1130 include the ability to treat the entire vagina 804 by turning different electrodes on and off. This type of probe (with electrodes across the entire surface) can treat vaginal conditions other than SUI (reversion) throughout the vagina. However, to address specific tissue areas targeted for SUI treatment, electrodes 1162 within the desired anterior region of the vagina (e.g., between the 10 and 2 o'clock positions) can be activated, while other electrodes remain deactivated. Furthermore, this probe can allow the clinician to adjust the position range beyond 10 to 2 o'clock, for example, by activating more electrodes to treat a larger area of ​​tissue, up to and including the entire circumference of the vagina. This probe can also allow the clinician to adjust the position range narrower than 10 to 2 o'clock, for example, by activating fewer electrodes to treat a smaller tissue region. Thus any desired area (or the entire vagina) can be selected for treatment.

[0337] Various aspects of RF treatment control can be based on feedback from multiple temperature sensors along the urethra. If the urethra is the target of heating of stimulating tissue and surrounding muscle tissue, installing monitors within the urethra can help standardize clinical outcomes and significantly improve safety. Therefore, monitoring temperature at discrete locations along the catheter can facilitate detection of any thermal anomalies, such as hot spots. Additionally or alternatively, these discrete temperature sensors can inform treatment endpoint decisions. Thus, variations in patient anatomy and tissue perfusion can be compensated for by monitoring the actual tissue temperature increase during RF energy administration.

[0338] In various aspects, the long duration low irradiance (about 1-5W / cm 2 ) and short duration high flux (about 10-1000 J / cm 2) scheme can also be used for internally accessible tissue and can provide comparative advantages with respect to biological target selection and treatment. Without being bound by any particular theory, the method of action can be thermal in nature, where the delivered RF power is used to heat or even coagulate selected tissue. For long, continuous exposures, uniform heating of the structure can be achieved. For short, concentrated bursts of energy, a focus of tissue ablation can be created. In various aspects, it may also be necessary to ensure the uniformity of the delivered RF energy. In order to provide effective treatment in some applications, it may be necessary not only to raise the temperature of the target tissue to a temperature range, but also to maintain the target tissue in the target tissue at the elevated target temperature for a given duration. That is, maintaining the temperature for a period of time can impart the desired clinical benefit. As discussed herein, it may also be advantageous to actively control the RF energy to distribute the energy uniformly, predictably, and automatically (e.g., without user intervention) through the target tissue in a homogeneous manner. In addition, the RF pulse duration can be used to select and / or target specific tissue. High-amplitude, short-duration RF pulses, when concentrated on a small electrode-tissue interface area, can generate sufficient flux or current density to coagulate and vaporize tissue, thereby causing the aforementioned "staged" treatment.

[0339] Now refer to Figure 12 , depicts another exemplary system 1200 according to the present teachings. As shown, system 1200 can include a console 1210, a coolant source 1238, a microprocessor 1237, an RF power source 1235, a switch control 1211, and measurement circuitry 1213 (which can be separate or housed together in a single console 1210). System 1200 also includes at least one probe 1230a having an array 1260a of associated electrodes 1262a. Each electrode 1262a of array 1260a can be independently switched by a switch control 1211 to gate RF energy to each electrode in the array. Electrodes not actively receiving RF energy can be monitored by measurement circuitry 1213, allowing each electrode to function as a signal channel, providing current, voltage, and / or phase angle feedback for calculating power and impedance at each individual electrode 1262a. System 1200 can also include an optional second probe 1230b to provide an electrical return path. The probe 1230b may also include an array 1260b to deliver RF energy or provide another mechanism for sensing impedance and / or other electrical parameters and / or temperature. In some embodiments, the probe 1230b may be incorporated into a catheter for placement in the patient's urethra. Alternatively or additionally, the system 1200 may also include, for example, a return (ground or neutral) pad 1230e connected to the patient to provide a drain for the applied current. In various embodiments, the system 1200 may be used with other applicators disclosed herein.

[0340] As discussed elsewhere herein, electrode arrays adapted for internal tissue surfaces according to the present teachings may also have a variety of configurations. For example, the electrode array may be configured as a probe comprising a metal coolant housing with an electrically insulating and thermally conductive layer (e.g., polyimide or ceramic, such as AlO2, etc.). The electrode array can be attached to the applicator cooling housing via an adhesive so that a circulating coolant (e.g., cooling water from a coolant source) can cool the electrode array and the patient's internal tissue surface (e.g., vaginal wall) with which the electrodes are placed in contact.

[0341] In various exemplary aspects, for example, the electrode array applicator can have 50 independently controlled electrodes arranged in a square, circular, or hexagonal pattern. Additionally or alternatively, the surface temperature of the patient's tissue surface (e.g., the vaginal wall) in an area surrounding the periphery of the applicator electrode array can be monitored by IR sensors, thermocouples, etc. (by way of non-limiting example) to identify uneven heating of the vaginal wall surface area adjacent to the intended treatment area. Based on these signals, the microprocessor and algorithms can provide correction factors for the RF power set points of the individual electrodes to optimize treatment uniformity, homogeneity, and placement of the treatment area. In various aspects, as discussed further herein, the impedance of the electrodes can be individually monitored, which can be used by the microprocessor and algorithms to define an impedance topography of the patient and provide correction factors for changing the RF power set points to optimize treatment uniformity, homogeneity, and placement of the treatment area.

[0342] Cooling the patient's internal tissue surface (e.g., mucosal lining, vaginal wall) to which the electrodes are applied can protect the tissue surface and can also improve patient comfort during the procedure or minimize postoperative discomfort. Adequate surface cooling (e.g., via circulating water at approximately 10°C to 35°C within the probe) allows for safe and comfortable application of larger amplitudes of RF power. This may be desirable because most target tissue is located at a certain depth from the internal tissue surface (e.g., the surface of the vaginal wall), so surface cooling serves to protect intervening tissue layers that are not targeted and allows heat to penetrate deeper into the tissue. Because mucosal tissue often has nerve endings close to the surface, cooling the tissue surface enables the subject to tolerate higher temperatures at the desired treatment depth below the cooling surface.

[0343] As discussed above, individually switchable electrode arrays (e.g., individually controllable electrodes that can individually adjust / control RF power delivery) can be provided to help ensure or control that the treatment zone remains centered within the desired treatment zone (beneath the electrode array applicator) and that a homogeneous and consistent temperature increase is maintained within the desired treatment zone, regardless of variations in the patient's underlying tissue electrical impedance or anatomical structure. Each electrode (or subset of electrodes) within the array can be individually addressed and activated. For example, an impedance map can be generated for the entire vaginal vault, and based on this impedance information, activation of only certain electrodes can be controlled to avoid untargeted structures. The surface temperature of the vaginal wall (and / or urethra) can also be monitored and used for RF uniformity compensation. The application of uniform RF energy (e.g., at a frequency of approximately 1 MHz) through the vaginal wall and then into deeper tissue is complicated by different tissue types and different impedance variations. For example, fibrous structures and connective tissue have a lower impedance to RF energy than fat. Therefore, RF energy will preferentially propagate along the connective fibrous tissue opposite fat. The heated connective tissue then diffuses and / or conducts heat from the fibers into adjacent fat cells, raising their temperature. Similarly, muscle tissue has a much lower impedance than other tissue types. Because predictable RF uniformity is important for the effectiveness and safety of the applied RF treatment, the heterogeneous tissue structure in the target area should be taken into account. Because some tissue structures have higher impedance relative to other tissue structures (e.g., deeper muscle tissue), the RF energy delivered uniformly on the surface can "drift" toward the direction of minimum impedance. RF energy will typically propagate to deeper tissues through the shortest path length of the high-impedance layer closest to the vaginal wall. Therefore, as discussed elsewhere herein, only one electrode (or a subset of the electrode array) can be activated based on tissue feedback (e.g., based on impedance and / or temperature feedback), and / or the power, duration, duty cycle, etc. of the RF signal provided to each electrode can be individually adjusted to help provide uniform heating.

[0344] As discussed above in accordance with various aspects of the present teachings, administration of varying RF pulse durations can be utilized to provide selective tissue treatment and / or a variety of treatments. For internal tissues, for example, long duration (e.g., greater than 1 second, CW) low power RF energy (e.g., about 1 to about 5 W / cm2) can be contemplated. 2 ) and short duration (e.g., less than 500 ms, less than 100 ms) high energy RF pulses (e.g., about 10 to about 1000 J / cm per pulse) 2 , 10J / cm 2 -500 J / cm 2 , 10J / cm 2 -300 J / cm 2 , 10J / cm 2 -100 J / cm 2) approach. In some aspects, high-amplitude, short-duration RF energy pulses can be used to generate sufficient flux or current density to ablate, coagulate, and / or vaporize tissue. For example, the RF pulses can be concentrated (e.g., focused) on a small area of ​​the electrode-tissue interface to induce sufficient flux or current density to coagulate and vaporize tissue.

[0345] refer to Figure 13 , depicts the results of an exemplary RF-based treatment of a bovine liver, wherein an electrode array is spaced and configured to deliver heat to multiple tissue sites within a target area such that treated portions are separated by untreated portions. In particular, the exemplary electrode arrays each include 20 electrodes to which an RF signal is applied while the electrodes are in contact with the liver surface. The RF signal includes 25 ms pulses with a pulse energy of approximately 30 mJ per electrode in each of the 20-electrode array. Figure 13 As shown, this exemplary treatment can be used to provide damage (e.g., ablation, coagulation) to isolated islets within a larger volume. In this "staged" treatment, damaged islets (vaporized tissue) are surrounded by healthy tissue that is substantially undamaged by the application of RF energy. In various aspects, the adjacent undamaged (e.g., healthy) tissue can improve the healing process of the islets of damaged tissue.

[0346] Figure 14A The results of another exemplary "staged" treatment are depicted in Figure 1-C. The RF signals applied to two electrode arrays (each array having 20 electrodes for each of these figures) presented the same pulse energy of approximately 30 mJ per electrode in each array, but the duration of the RF signals was different. For example, Figure 14A Shown are multiple isolated islands of vaporized tissue on the patient's skin surface resulting from the application of 35 millisecond RF pulse duration and energy to each electrode in the array. Figure 14B Depicts the isolated islets induced by using a 25 ms pulse duration, whereas Figure 14C Depicted are isolated islands resulting from the use of a 12 millisecond pulse duration. It can be observed that for the same energy per pulse, a shorter pulse duration results in more damage (eg, tissue vaporization) at the focal point.

[0347] As discussed herein, the present disclosure is directed to various embodiments. These embodiments include various applicators and electrode array designs that sandwich or combine or connect various components (such as reusable and disposable components). Designs based on flexible electrode array printed circuit boards can include any suitable rectangular, arcuate, circular, regular and / or irregular shapes and combinations thereof. These flexible electrode arrays can be paired with foams, gels and other materials to help fit the patient. They can also be paired with rigid components that contain electronic components designed for reuse. This approach helps solve the technical problem of creating RF-based treatment devices that can be used in a timely and effective manner to improve patient comfort.

[0348] Uniform heating systems and methods and additional applicator embodiments

[0349] In part, this disclosure describes a flexible, non-invasive, body-contouring applicator suitable for directing RF-based energy. The flexible applicator can be relatively thin. In various embodiments, the thickness of the applicator ranges from about 3 mils to about 10 mils. In one embodiment, the thickness of the applicator is less than about 10 mils. In one embodiment, the thickness of the applicator is greater than about 5 mils and less than about 12 mils. In various embodiments, the flexible applicator includes multiple separate treatment zones, each of which can be configured to reach a target temperature using one or more control systems by selectively energizing the zones in a pattern to gradually bring the entire zone within a preferred treatment temperature range. The applicator uses an RF energy source / generator to generate heat through each treatment zone using RF heating via conductive traces and / or a dielectric gradient. In some embodiments, the applicator is connected to the RF generator via an interface device that includes an electronics subsystem. The interface device is fixedly and releasably connected to a disposable applicator and operates as a quick disconnect / connect device. Individual zones / areas of the applicator can be energized to achieve uniform heating of each such zone / area. Furthermore, the zones / areas of the applicator are selectively energized to facilitate uniform heating of the entire area of ​​tissue in contact with the applicator.

[0350] A given flexible RF applicator can be activated using an RF source having a specific operating frequency. In various embodiments, the operating frequency can be in the range of approximately 0.5 MHz to approximately 10 MHz and as further disclosed herein. In one embodiment, the RF frequency used with the flexible applicator is approximately 3 MHz or approximately 4 MHz. Furthermore, zones or areas of the applicator can be addressed according to various schemes and patterns, wherein various delay periods and variations in addressing patterns can be controlled by the operator, for example, by the individual operating the device and / or by achieving a predetermined temperature target for each zone / area, which is maintained within a predetermined temperature range for a predetermined timeframe. A given applicator can be connected and addressed using various distribution systems. Zones or areas of the applicator can be activated or addressed, thereby directing input electrical signals to a given zone or area on a zone-by-zone or region-by-region basis using random, cyclic, alternating, zigzag, and other addressing / activation schemes. Heating a tissue region beneath each interrogation zone of the applicator allows for uniform heating without discomfort. This can be achieved by cycling between and activating different zones, with heat spreading from one zone to another to promote heating of the entire aggregated tissue portion or an area located within or extending beyond the applicator.

[0351] In various embodiments, not all areas of the applicator are typically energized simultaneously, although this may be possible in some cases. Typically, areas of the applicator are selectively energized according to one of the aforementioned schemes or modes to promote uniform heating of the body area below the area / region of the heated applicator. In addition, the applicator includes multiple layers arranged in a stack or combination of sub-stacks. In turn, the applicator has a shape that is partially defined by an outer boundary or border. The overall shape of the applicator is typically curved, with sharp edges and straight lines being avoided as part of the applicator border. Oval, circular, arcuate profiles and curved borders, as well as combinations and fractions of the foregoing, are preferred to mitigate edge effects and uneven heating.

[0352] Various flexible and / or conformable applicators may also be used to perform RF-based treatments and treatment methods, including the cosmetic treatments disclosed herein. Figure 15AA flexible RF-based applicator 880 suitable for directing RF energy to one or more tissues and body regions / volumes is shown. As shown, the applicator 880 has six regions or zones R1, R2, R3, R4, R5 and R6 divided by seven cutouts K. The cutouts K help the applicator 880 conform to the contours of patient tissue, such as, but not limited to, the skin, abdomen, and other patient tissues in general. In one embodiment, the cutouts are implemented as gaps between the regions that allow a flat applicator to conform to complex curved surfaces. In various embodiments, the shape of the cutouts and the circular or elliptical strain relief elements at the ends of the cutouts are defined by the shapes of the cutouts and the circular or elliptical strain relief elements at the ends of the cutouts. These strain relief elements / terminal strain relief elements can be incorporated into the various applicator designs disclosed herein.

[0353] Generally, in some embodiments, the applicator can include two or more regions with one or more incisions K. In some embodiments, the applicator 880 can have one region and no incisions. The applicator is flexible and adapted to conform to one or more surfaces of a patient's skin, tissue, muscle, organ, body cavity, organ system, and other areas and surfaces on or within the patient's body. The applicator 880 includes an electrical connector 890 comprising a plurality of electrical contacts 892. The contacts can be connected to electrical traces disposed in or on the applicator.

[0354] In one embodiment, the electrical connector 890 is part of the applicator 980. The electrical contacts 892 are connected to the electrical traces and other electrical components of the applicator. The applicator 880 may also include a strain relief device / element 885 that is arranged relative to, for example, by a flexible layer surrounding or clamping the applicator and the electrical connector 890. The electrical connector 890 may include one or more alignment devices 895 that are suitable for facilitating alignment of the electrical contacts 892 with corresponding electrical contacts of the interface device. The first surface 900 of the applicator may include one or more labels. In one embodiment, an integer N or other variable may be used to refer to N conductive traces, such as copper traces that direct RF to N external regions of the applicator. A given set of patterned traces arranged in a configuration such as a spiral, annular, or other concentric or nested configuration may be used as an RF transmitter for a given applicator or region thereof.

[0355] Uniformity-Flexibility / Contour

[0356] In various embodiments, the applicator has a cutout K. A cutout is a void or cutout in the stack of flexible layers that acts in a manner similar to a spur in clothing, enabling the applicator sheet to conform to the contours of the body while maintaining contact. The use of a cutout can improve the tolerance of the sheet thickness. When the applicator size is greater than about 50 cm 2The cutouts K allow the applicator to accommodate a larger treatment area and be used for multiple zones / areas R1-RN in a single applicator.

[0357] Generally, the regions or zones of the applicator are separated by incisions, channels, gaps, cavities, voids, or other defined spaces to facilitate the use of a flexible applicator that is bendable and adjustable relative to tissue regions, such as any of a plurality of regions of the stomach, abdomen, submental area, organs, organ systems, skin, subcutaneous tissue, body tissue, face, arms, legs, and other regions, cavities, or volumes of a patient. Selective and alternating excitation of the regions of a given applicator is performed to facilitate uniform heating of the target tissue, with the regions of a given RF-based applicator separated along one or more boundaries, such as incisions or channels.

[0358] A given applicator comprises a stack of layers and has a Figure 15A The first side 900 is shown. The second side or tissue-facing side is the surface opposite the first side. Figure 18 and 19A and described elsewhere herein. In general, each applicator has a first side and a second side. In one embodiment, the first side 900 corresponds to the marking side, also referred to as the vinyl or polymer side or the upper side or the top side. Alternatively, the second side refers to the gel side, wet side, bottom side, or the side facing the patient. The wet side refers to the presence of an aqueous material or gel disposed on one side of the applicator. The gel or other aqueous material helps maintain skin contact and position the applicator area for targeted RF energy delivery and subsequent tissue heating. References to the first side and the second side are not limiting and may refer to any of the aforementioned sides of the applicator as dictated by the context.

[0359] Shape / scalability

[0360] In various embodiments, the applicator can have different shapes. Preferably, the applicator has a curved border, as opposed to a straight edge, such as a polygonal border. Oval, circular, elliptical, curved, and other shapes can be used to specify the shape of the applicator and / or its outer edge or border. For example, in various embodiments, the applicator is shaped as an oval or a rugby ball, with a surface area of ​​a particular patient size or tissue of interest (i.e., approximately 225 cm 2 or about 300cm 2) are customized. Larger applicators are designed for larger treatment areas, such as, but not limited to, the abdomen and thighs, while smaller applicators are suitable for smaller treatment areas, such as the face or arms. The geometry, size, and coverage of the applicator can be scaled based on the potential area on the body to be treated. In addition, in various embodiments, the applicator can include various numbers of zones or regions R, such as, but not limited to, 6 zones R1-R6, 12 zones, 48 ​​zones, or other numbers of zones. Each zone is typically bounded by one or more incisions. The geometry and size constraints can be configured based on the energy available from one or more systems described and depicted herein (such as systems 100, 800, 1200).

[0361] In various embodiments, the applicator can selectively control and / or turn on / off one or more zones. In some embodiments, the zones can be selectively sized to effectively treat a zone that is smaller than an adjacent zone. Additionally, in some embodiments, the applicator can be shaped to include one or more voids or areas without RF transmission elements, or programmed to not energize certain RF transmission elements or areas to compensate for sensitive areas (i.e., navel, scars, etc.). This can be controlled by a user interface on a display connected to the system 100. Exemplary portions of the applicator that can be used to compensate for the presence of a navel, scar, or other depression are shown in FIG. Figure 15C This is shown as area 912. Figure 15C As shown, region 912 is a portion of zone R5. In some embodiments, an entire region, such as region / region R5 of applicator 905, can be selectively avoided so that RF energy is not transmitted to the navel or other sensitive areas. In other embodiments, region 912 can be enlarged, reduced, and / or moved to other areas depending on the location of the sensitive area. Figure 28A and 28B Deactivation of an area of ​​a user interface suitable for use with the processing systems and applicators disclosed herein is shown in FIG.

[0362] In various embodiments, by selecting the dielectric / trace for a given zone to avoid unwanted edge effects, in some embodiments, each zone / area uses one temperature sensor, such as a thermistor, to regulate the target tissue temperature, such as skin temperature. In some embodiments, two thermistors are provided per zone for redundancy and to provide a backup in the event of a failure. For example, in Figure 15AIn region / zone R5 of the applicator surface 900 in FIG. 2 , two temperature sensors H are shown. Each temperature sensor H is connected to one or more electrical conductors that, in turn, are in electrical communication with one or more electrical contacts in the electrical connector 890. In some embodiments, one temperature sensor H is provided per zone or region. The thermistor provides an external temperature reading, such as a tissue or applicator surface temperature reading, and the internal depth temperature is discerned based on the external temperature reading. In one embodiment, one or more applicator temperature sensors (such as a thermistor) are used to measure the external surface or applicator surface temperature of the tissue. The internal temperature at depth is then discerned from this reading. This is because the internal temperature is correlated with the surface temperature of the tissue / applicator that contacts the tissue.

[0363] The target skin surface temperature range is from about 40° C. to about 44° C. This correlates to a temperature at depth ranging from about 41-45° C. In some embodiments, the temperature range may extend to about 42 to about 47° C. due to heat accumulation.

[0364] In at least one embodiment, when applied to skin tissue, the applicator provides uniform heating up to a target surface temperature range (about 40 to about 44°C), which corresponds to a range at a certain depth in fat tissue (about 42 to about 47°C). In various embodiments, the temperature is measured at the surface of the skin tissue and the temperature of the treated skin surface is used to determine the temperature of the underlying tissue (i.e., the fat tissue below the target surface). One or more heat / temperature sensors are integrated into each area or section of a given applicator. In various embodiments, two heat / temperature sensors (such as, for example, thermistors) are provided in each applicator area.

[0365] In various embodiments, the applicator is capable of individually setting the temperature of each individual treatment zone. In some embodiments, one or more individual zones may have different target temperatures or may be turned off entirely depending on the prescribed treatment process. For example, a treatment zone placed over the navel area may be turned off due to sensitivity. In various embodiments, the amount of zone heating can be determined by the change in resistance to the ratio of resistance (ΔR / R), which is the change in impedance. During treatment, the applicator is configured to maintain the specified temperature within the target temperature range for at least about 12 minutes. In one embodiment, an example range of treatment time is from about 12 minutes to about 15 minutes. In one embodiment, the time each zone is energized is 12 to 15 minutes divided by the number of applicator zones.

[0366] In various embodiments, the applicator is suitable for applying energy to a uniform volume of tissue. Uniformity or overall uniformity is achieved by using zone-by-zone uniformity on each treatment zone of the applicator. In some embodiments, each zone / region is heated for a time period of P or about P, ​​wherein the total treatment time TTT is the product of (about P or P)(the number of applicator zones). In one embodiment, the range of about P or P is about 20 seconds to about 2 minutes. In one embodiment, the range of about P or P is about 40 seconds to about 3 minutes. In one embodiment, the range of about P or P is about 1 minute to about 2 minutes. In one embodiment, the range of about P or P is about 1.5 minutes to about 2.5 minutes. In one embodiment, the range of about P or P is about 1 minute to about 10 minutes. In one embodiment, the range of about P or P is about 1 minute to about 3 minutes. In one embodiment, the range of about P or P is about 2 minutes to about 8 minutes.

[0367] Energy applied by the applicator may cause heat to spread beyond the boundaries of the applicator. For example, in at least one embodiment, the tissue beneath the incision ultimately reaches a uniform temperature or within a specific treatment temperature range due to heat delivered by two or more regions of the applicator and transferred across the tissue beneath the incision. In one embodiment, the incision terminates within the boundaries of the applicator at a channel, hole, or other opening, such as Figure 15C 910 is shown in FIG. In some embodiments, the holes or openings are circular or oval. These holes or openings can be used as stress relief elements.

[0368] like Figure 15A As shown, the applicator surface 900 includes zones or regions 1-6, R1-R6. In some embodiments, the applicator includes an outer label showing and listing 1-6, R1-R6. Figure 15C Such a labeled outer layer is shown in applicator 905 in FIG, wherein regions 1-6 illustrate numbers printed on the applicator label, each number within a circular boundary. In one embodiment, the numbers printed on the label are white, but may be any suitable color. In one embodiment, the label comprises vinyl, plastic, or another polymeric material. Labeled regions 1-6 correspond to applicator regions or regions R1-R6. These regions may be displayed on a user interface to facilitate deactivation of one or more zones prior to commencing treatment.

[0369] In one embodiment, each zone or area is bounded by two incisions K, for a total of seven incisions K. In some embodiments, the applicator may use fewer zones, more zones, and / or have different shapes and sizes. The limitations on the geometry and size of the applicator depend on whether the RF generator can provide sufficient energy to heat the desired treatment area. In the initial stage of treatment, each treatment zone of the applicator is activated in a clockwise manner, R1 to R2, R2 to R3, R3 to R6, R6 to R5, and R5 to R4. A counterclockwise activation scheme or other activation schemes and modes as described herein may be used. Thereafter, the temperature of each zone is measured using a temperature sensor H and modified as needed to maintain the set surface temperature (40-44°C). Each treatment zone is individually maintained at a temperature within the range of (42-47°C) to achieve the set surface temperature (40-44°C) for the entire area covered by the applicator. In this embodiment, the applicator covers an area of ​​300 cm 2 In various embodiments, the applicator may range in size from about 50 cm 2 to about 600cm 2 In one embodiment, the label used on the applicator surface 900 may comprise a polymer and be designed to look like a metallic surface, such as brushed chrome or another gray or silver metallic visual element. In one embodiment, the applicator includes a label that includes one or more pigments arranged to display a metallic, metal, or metal-like appearance.

[0370] Flexibility

[0371] In various embodiments, the flexibility of the applicator is enhanced by cutouts / voids that make the applicator flexible enough to conform to the contours of the body. Figure 15A As shown, each cutout frees up a respective portion / region of the applicator to flex depending on where on the body that portion / region is to be applied. Figure 15A The applicator shown has a total of seven incisions K. In various embodiments, the number of incisions employed depends on the size and shape of the applicator and how the applicator is intended to be applied to various body parts. In various embodiments, each applicator includes multiple non-incision areas, such as internal regions or spines, from which regions or areas extend and before which the various incisions terminate. The exemplary internal region 495 is Figure 22A. The interior region typically includes a high density of substantially parallel conductors that branch to supply current to the various regions. The density of conductors is high because an increasing number of conductive traces are placed adjacent to each other in this region. As a result, the interior region can generate excessive heat. As a result, the interior region may include one or more thermal shields. The interior region 495 has a telescopic, skyscraper, stepped, or tapered configuration that decreases as the number of adjacent traces decreases in the direction of the dashed arrow AW away from the applicator's electrical connector 890.

[0372] The dielectric of the applicator has a dielectric constant ranging from about 3 to about 4, which provides a balance of capacitance and dielectric thickness while also providing flexibility for the applicator to contact patient tissue. As another consideration, when selecting a dielectric material for the applicator, it is desirable that the material have low heat loss or heat dissipation factor and also be able to withstand high temperatures to allow for soldering of components relative to the conductors used with the dielectric material. Furthermore, the selected dielectric of the applicator is skin-safe and biocompatible. For example, in one embodiment, Kapton is a dielectric that meets these requirements. However, Kapton can be substituted for any dielectric that meets these requirements.

[0373] Uniform Heating - Applicator Considerations

[0374] In various embodiments, each zone of the applicator includes multiple RF traces to provide RF energy and / or heating from each zone. Without any thermal management, the RF traces may cause edge effects that make it difficult to provide uniform heating from the applicator. A relatively flexible dielectric insulating material, such as Kapton, may be selectively placed to promote uniform heating in a given treatment zone.

[0375] Figure 18 An exemplary arrangement of materials 940 of an applicator or a portion thereof, such as a region of an applicator, according to an embodiment of the present disclosure is shown. The layers are also combined to form Figure 19AApplicator 980 in. As shown, there is a first side 900 and a second side 945. In one embodiment, the first side and the second side correspond to a vinyl side and a wet side, or vice versa. Alternatively, in one embodiment, the first side and the second side correspond to a patient-facing side and an air-facing side, or vice versa. During treatment, the wet side comes into contact with the patient tissue to be treated. In some embodiments, an aqueous gel, such as a hydrogel, is applied to the tissue-facing / wet side to reduce or avoid air gaps. Additionally, the use of such a gel can increase the amount of current that can penetrate the tissue. In various embodiments, one or more thermistors are placed within each zone to monitor temperature during a given treatment method. The temperature sensors communicate with a control system and can be used to change the current level when higher RF energy and associated current levels may cause edge effects or uneven heating. In at least one embodiment, the six-zone applicator includes a thermistor in each zone.

[0376] like Figure 18 As shown, an optional release liner 946 may be included in the sterile, disposable applicator and removed before the applicator is applied to the patient. In some embodiments, the liner protects the gel layer 960. Two dielectric material layers 950A, 950B sandwich a conductive layer 955 and a polyimide layer 957 using an adhesive, which may be provided as two layers 953A, 953B. In various embodiments, the dielectric material layers may include Kapton layers, such as cover layers or overlay layers. Layers 950A, 950B, 957 may be dielectric layers, such as first, second, and third dielectric layers. Conductive layer 955 includes an arrangement of metal or electrical traces. In various embodiments, the conductive layer includes copper or copper traces. The copper layer may include a continuous, thin layer of copper metal. Alternatively, for various embodiments, the copper layer includes multiple copper traces extending into each area or zone of the applicator. The closer the traces are placed to each other, and the more traces are grouped in parallel, concentric, or other configurations, the higher the trace density. Also shown is a patient contact layer 945, such as a water-based gel layer. Figure 19A The exploded view of the applicator shows Figure 18 The arrangement of each layer.

[0377] exist Figure 19A, a release liner 946 is adjacent to or beneath the gel layer 960. An insulating layer 975 is also used to protect the interior area or spine of the applicator. In some embodiments, the insulating layer 975 is elongated and optionally flared or tapered. The flexible applicator 880 includes the conductive layer described above, multiple dielectric layers, and an adhesive layer. As discussed herein, a label can be provided on the applicator. Additionally, another release liner 947 can also be used. A strain relief element 885 can also be used to reinforce an extended area of ​​the applicator including the electrical connector 890. In one embodiment, an elongated area 893 extends from the applicator, such as terminating at a tail or parallel cable of the electrical connector 890. Figure 19B and 19C Shown Figure 19A Different views of the combination of layers shown in . Figures 20A-20F Different views of an applicator 980 with one or more release liners are shown. Figures 21A-21F Various views of the applicator 981 are shown without the release liner.

[0378] like Figure 22A and 22B As shown, the copper traces can be arranged in various patterns such as various paths. In some embodiments, the copper traces are arranged in the form of spirals, area-filled curves, nested straight areas, nested curved areas, and combinations thereof. Examples of conductive traces 490 are shown in FIG. Figure 22A and 22B The center of a given area includes a higher concentration of copper trace material, while the periphery of the same area shows a thinner copper gradient towards the peripheral edge.

[0379] In various embodiments, the copper traces are arranged to have a greater location density or clustered in the center of an area or a particular portion of the applicator. In some embodiments, there is a higher concentration of copper trace material in the center portion of a given area due to the placement of more copper traces relative to each other. Thus, in a portion of the applicator in a given area, there are more traces placed adjacent to each other than other traces, thereby increasing the density or number of copper traces per unit area. A single set thickness is typically used for the traces. Although this thickness can vary within a suitable range, for example, from about 0.01 inches to about 0.3 inches. In some embodiments, a group of traces with a common width or thickness can be densely clustered in one area and less densely clustered in another area. For example, in a ridge area, multiple traces are positioned adjacent to each other in parallel, side by side, adjacent, or other ways. This can result in additional heating of the area relative to the increased traces positioned relative to each other and benefit from including one or more thermal shielding layers.

[0380] In various embodiments, Kapton can be replaced with another suitable dielectric, depending on the preferred dielectric properties described herein. Additionally, in these embodiments, the base polyimide can be replaced with another dielectric, namely polyester. In various embodiments, Figure 18 The thickness of each layer ranges from about 0.5 mils to about 1.5 mils. In various embodiments, the optional hydrogel layer has a thickness greater than 1 mil.

[0381] The applicator is typically designed to be disposable and to work with a suitable interface device 918, such as Figure 16 As shown. The interface device 918 is in electrical communication with an RF-based processing system such as system 100, 800, 1200 or other suitable systems disclosed herein. The interface device supports the use of sterile applicators and changes to applicators of different sizes, shapes and areas, which facilitates the alignment of electrical traces. The interface device 918 also supports the quick connection and release of the applicator from the interface device. The interface device shown is an exemplary device for connecting the applicator. In another embodiment, a pluggable cable interface that is releasably attached to the electrical terminals of the applicator and other interface devices suitable for aligning and contacting multiple electrical contacts at the electrical terminals of the applicator can be used.

[0382] As shown, Figure 16 The interface device 918 depicts a clamp / clip device 920 and a cable adapter 921. The cable adapter 921 may include one or more electrical conductors and / or one or more optical connectors or optical devices, such as light pipes or fiber optic sections. In various embodiments, the light pipes or fiber optic sections are used as part of the interface device to support optical displays when the applicator is energized or when in a particular state or process. The clamp / clip device 920 may include one or more electro-optical conversion devices. The cable adapter 921 can be connected to other extension cables or subsystems. In one embodiment, the cable adapter 921 is connected to one or more systems disclosed herein, such as systems 100, 800, 1200. Additional details of the interface device are discussed in more detail below.

[0383] Due to the presence of edge effects in RF traces, the applicator uses selective dielectric insulation to create various dielectric insulation gradients across the applicator surface and to grade and / or scale the trace geometry by creating copper traces with various gradients across the applicator surface. Figure 22A 、 22B ) Both manipulate edge effects to achieve better temperature uniformity and flexibility.

[0384] Figure 17 An alternative applicator embodiment 905 is shown that includes nested dielectric regions. Within the applicator, in one embodiment, a conductive layer comprising copper is evenly distributed throughout. Figure 17 As shown, the surface of the applicator is a gradient dielectric with multiple layers of dielectric, such that the center of a given area has a single layer of dielectric (1 mil thick). For each area, as you move outward from the center, each subsequent gradient has an additional layer. For example, the center has one layer of dielectric DL1, the next outward gradient has two layers of dielectric DL2 (1 mil thick), the next outward gradient has three layers of dielectric (3 mils thick) DL3, and finally the periphery includes four layers of dielectric DL4 (4 mils thick). The central area 913 is the hole defined by the layered components of the applicator and is suitable for placement over the navel or other sensitive areas.

[0385] In various embodiments, the applicator is an adaptive applicator that applies RF energy to heat one or more areas. In at least one embodiment, the applicator is used with a waveform generator operating at approximately 4 MHz. A 4 MHz generator is useful for providing RF energy uniformly across a dielectric using thin, common materials over a large area. However, in other embodiments, other high-frequency generators may be used. In one embodiment, a 3 MHz generator is used. A suitable waveform generator for use with the flexible applicators disclosed herein is typically a component of one or more systems disclosed herein or is in electrical communication with one or more systems, including systems 100, 800, and 1200.

[0386] In various embodiments, for a given capacitive electrode area, the application of RF energy and the placement of current in the body depends on various characteristics. For example, as the thickness of the dielectric decreases, the RF current and any tendency of air ionization increase proportionally. As the relative permittivity (i.e., dielectric constant) of the dielectric layer increases, the RF current and any tendency of air ionization increase proportionally. As the voltage applied to the electrode increases, the RF current and any tendency of air ionization increase proportionally.

[0387] As the frequency of the RF waveform increases, the RF current increases proportionally. In contrast, any tendency for air ionization does not increase proportionally. Thus, the RF frequency can be increased to increase the RF current per unit area without increasing the tendency for corona discharge or plasma to form in the air near the tissue being treated by the applicator. Therefore, mitigating corona or plasma discharge is one of the advantages of the RF-based applicators disclosed herein. In various embodiments, the frequency range of the RF generator is from about 1 to about 5 MHz. In some embodiments, a 4 MHz generator balances the needs because inductance can be problematic at higher frequencies and the capacitance gradient required for uniform heating at lower frequencies is more difficult to achieve.

[0388] In various embodiments, the applicator utilizes or manipulates edge effects through selective dielectric insulation placement and positioning, produces various dielectric insulation gradients, such as through thickness variations across the applicator surface, and grades and / or scales trace geometry by producing various gradients of copper traces across the applicator surface. Examples of such traces 490 are shown in FIG. Figure 22A and 22B The tapered trace geometry creates multiple edges so that the edge effect is present across the entire applicator surface, providing a pattern that results in substantially uniform heating. In addition to the temperature uniformity provided by the applicator, the flexibility of the applicator is also considered when determining the topology of the electrical gradient and / or copper trace gradient within the applicator.

[0389] In various embodiments, the material patterns sandwiched together are as follows: dielectric, copper, dielectric, etc. A variety of stacks of material layers can be used for a given applicator. Consequently, various sandwich structures are possible, with one or more layers sandwiched between two layers, a stack of layers, or two stacks of layers.

[0390] In various embodiments, a given applicator has a skin tissue contacting side 945. The skin contacting side includes a material that is wet enough to conform to the stratum corneum therebetween. For example, in at least one embodiment, a thin adhesive that is slightly conformable (i.e., "wet") enough to conform to the stratum corneum will work well to allow coupling into the skin. The thin adhesive helps avoid air gaps, which can reduce how much current can be coupled into the body. The air gap is filled with a water-based material, preferably a water-based material, with current-carrying ions, such as saline as part of various treatment methods. For example, a suitable material may include a hydrogel. In an alternative embodiment, an aggressive thin adhesive will also work, but should be made in a manner that allows it to "wet" into the stratum corneum. In various embodiments, the applicator can be pre-wetted so that the covering is peeled off before applying the wet side to the subject's skin. Various embodiments include removable coverings, such as releasable liners, such as Figure 19A 、 19B , 19C, 20A and those shown in 20B.

[0391] For example, a conductive hydrogel is loaded onto the side of the applicator facing the subject, the hydrogel compensating for bumps, hair, and adhering the applicator to the subject's body. The hydrogel moisturizes the skin and makes it sticky or tacky. An alternative could be a conductive adhesive or a pressure-sensitive adhesive. However, another embodiment could include a dry surface, and the subject's skin is moistened with a wetting substance (e.g., ultrasound gel, hydrogel), and the applicator is then held in place. In some embodiments, a bandage is wrapped around all or part of the applicator and the subject's body to ensure that the applicator remains in place. Such an applicator may be less convenient because correct placement may require two practitioners to apply the applicator and / or a belt or wrap to hold the applicator in place.

[0392] Quick connect interface device

[0393] The applicator can be connected to the system using various types of interface devices, connectors and adapters, e.g. Figures 1A-1F , 8 and 12. The relative placement of the applicator and the clamp 920 Figures 23A-23C An exemplary interface unit is shown in FIG. Figure 16 shown. Figures 23A-24F Additional views of the interface device are shown in . The interface unit 918 includes various components. A cable interface device / cable interface adapter extends 921 from the clamp 920. In some embodiments, the cable is fixedly attached to the interface device, while in other embodiments, it is releasably attached, such as by being pluggable relative to the interface device. In some embodiments, the applicator includes a plurality of electrical traces at its connection interface. With the goal of matching the electrical traces to corresponding interface device traces for specific connections, the interface device is a spring biased clamp / clip. In this way, when the interface device is compressed, it opens to receive the Figure 23C The terminal portion of the applicator a is shown. The applicator terminal includes one or more alignment features to facilitate proper mating and alignment of the terminal electrical connections in the applicator, such as through an alignment device 895. The alignment device 895 can include a hole or other area or shape defined by the connector 890 that is designed to mate and align with the connector in the interface device 918, such as a pin, groove, etc. In other embodiments, the interface device can be used with other applicators disclosed herein. Figure 23C The clamp is shown in an open position ready to receive and electrically connect to the electrical connector of a given applicator. Figures 24A-24F Various views of the interface device 918 are shown.

[0394] The interface device includes an upper or top housing, a lower or bottom housing, and an electrical subsystem that may include a printed circuit board. The top and bottom housings sandwich the printed circuit board in one or more optical connectors.

[0395] Distributor function

[0396] The applicator is connected to the RF generator using an interface device, such as a durable quick disconnect clamp embodiment and other devices disclosed herein. The interface device is connected to a distribution box, which is connected to the RF generator RFG. In one embodiment, the distribution box includes a printed circuit board and / or a set of circuit components. In one embodiment, the interface device includes the distribution box and provides distribution and / or control functions while also locking and releasing the disposable applicators. In a given distribution box / hub embodiment, the distribution box / hub is configured to monitor and control various areas / zones of the applicator with minimal crosstalk. Figures 25A-25C Various dispensing arrangements suitable for use with flexible RF-based applicators and other applicators disclosed herein are shown in .

[0397] In one embodiment, the distribution box / hub avoids the use of multiple umbilical cables that may cause crosstalk / signal interference. In one embodiment, a splitter for two or more umbilicals may be used simultaneously.

[0398] Figure 25A A distribution system is shown that includes a distribution box local to the applicator that performs the task of routing RF from the generator and distributing it locally to the individual electrodes for improved feedback control.

[0399] In various embodiments, Figure 25B The system shown in includes a distribution box local to each applicator. The applicator and distribution box combination receives RF from the generator through a second distribution box. Figure 25C The architecture shown in also has a distribution box located locally at each applicator. However, in this embodiment, each distribution box is directly connected to the generator. These and other applicator connection schemes can be used with respect to the processing system 100.

[0400] Exemplary RF-based processing methods

[0401] In various embodiments, a multi-zone / multi-area applicator comprising one or more incisions and internal areas / ridges can be used to facilitate a variety of treatment methods. These systems and methods can include various non-medically related cosmetic and / or beauty treatments, such as for skin tightening and / or body contouring, such as by causing lipolysis. In one approach, a template is used to characterize one or more patient areas for treatment so that the patient and operator can reach a consensus on the treatment method and target area. Once the treatment is agreed upon, the patient can be marked and otherwise measured and evaluated to determine which applicator to use and various other treatment parameters, such as treatment time and a target temperature range for uniform heating. Typically, the patient's body is marked to outline the treatment area that will receive the one or more RF-based applicators.

[0402] In one embodiment, the patient lies down (after attaching the neutral electrode pad or NEM) and the subject is prepared using one or more of the following: using a hydrogel pre-disposed on an applicator, using a pressure sensitive adhesive pre-disposed on an applicator, applying the hydrogel to the patient and then applying it to the patient, and / or applying ultrasound gel to the patient, then the applicator, and then a bandage to keep the applicator attached. In various embodiments, the operator accesses the user interface of the system 100 to identify an area such as the navel or selects a small area on the navel (e.g., Figure 15C 5 or a subset of the areas such as area 912) and then close area 5 in the GUI before processing.

[0403] During the initial heating phase, the operator selects a predetermined cyclic zone / region activation scheme and then interrogates the tissue with RF to achieve the target temperature. In one embodiment, each zone / region is heated for a set time, such as a maximum time, for example, approximately 10 seconds, and then each zone is heated sequentially for 10 seconds until the target temperature is reached. In one embodiment, the target temperature is reached within approximately 1 to 60 seconds. A threshold of 42°C can be set so that when this temperature is reached, the thermistor will cause heating to stop. In various embodiments, each zone / region is initially heated in a predetermined sequence (i.e., a cycle) until the desired temperature is reached. For example, in one embodiment, each zone / region is activated for a specified time (i.e., 10 seconds) to bring the tissue to the desired temperature. As treatment progresses, the applicator zones are interrogated according to an alternating pattern or scheme (e.g., a cycle, a sequence based on zone number, a random pattern, or other). A given zone / region is actively heated for a period of time, and then another zone / region is switched and heated. In this way, switching between different zones and actively heating them before switching again to another zone can maintain the desired temperature or temperature range of the underlying tissue until the total treatment time is reached. In various embodiments, the treatment time may be from about 10 minutes to about 15 minutes. In various embodiments, the treatment time may be from about 12 minutes to about 24 minutes. In one embodiment, the tissue is interrogated on a region-by-region or area-by-area basis such that a given region or tissue underlying a region is maintained within a desired temperature zone for a desired period of time, for example, interrogating a region for 10 seconds to bring it within a range of from about 42°C to about 47°C or from about 42°C to about 44°C, and interrogating multiple times during the treatment process such that a total treatment time of from about 10 minutes to about 15 minutes is achieved.

[0404] In other embodiments, compressible foam is used to deflect tissue toward an applicator or array to contact one or more electrodes to facilitate or support a given RF treatment of the contacted tissue. In one embodiment, the electrodes are electrically coupled to reduce crosstalk by providing a sticky but easily removable adhesive applicator for pre-positioning on the target treatment area. Crosstalk can be reduced by including one or more insulating, conductive, semiconducting, such as gel or material or layer. When using one or more electrodes and / or applicators for RF-based treatment, these layers can be doped or formed using various insulating, conductive and semiconducting materials to reduce crosstalk or other electrical interference.

[0405] Figures 26A-26F Various views of an applicator constructed and configured for use in the submental area (i.e., the neck and / or chin area) according to embodiments of the present disclosure are shown. In one embodiment, the submental applicator includes two or more areas. In one embodiment, the submental applicator can be shaped as a portion of a circle or an ellipse, such as a semicircle, a sector, or half, a third, or another portion of an ellipse. Figure 26A Shown is a top view of a flexible RF-based applicator 2600 for treating the submental area. Figure 26B Shown Figure 26A A bottom view of the applicator 2600 is shown in FIG. Figure 26C and Figure 26D A side view of the applicator 2600 is shown. Figure 26E and 26F Shown are rear and front views of an applicator 2600 described herein.The submental applicator can include one or more release liners, although such liners are optional for the applicators disclosed herein.

[0406] Figure 27A An exploded view of the various layers of an applicator constructed and configured for the submental area according to an embodiment of the present disclosure is shown. Figures 19A-19C , an applicator 2600 for treating the submental area (i.e., neck / chin) has multiple layers. As shown, a release liner 2740 is adjacent to or below the gel layer 2735. A thermal insulation layer 2730 is also used to protect the inner area or ridge of the applicator. In some embodiments, the thermal shield layer 2730 is optionally flared or tapered. The flexible applicator 2725 includes a conductive layer, multiple dielectric layers, and an adhesive layer. As discussed herein, a label 2720 can be provided on the applicator. In addition, another release liner 2715 can also be used. Figure 27B and 27CDifferent views of the applicator with one or more release liners are shown. The applicator electrical connector 2710 is connected to the flexible applicator 2725. The system connects to the electrical connector 2710 using a mating connector 2705 which may also operate to provide strain relief.

[0407] Figure 27B and 27C Shown Figure 27A Two different perspective views of the applicator are shown in FIG.

[0408] Graphical user interface features

[0409] The functionality of the zone-dependent display / GUI helps protect sensitive areas and displays temperature information to the operator of the applicator-based treatment system. Figure 28A and 28B The GUI 2800 shows the treatment temperature for each zone (zones 1 through 6 shown), identifying when the zone is at treatment temperature and whether it is actively delivering RF. In some embodiments, for example Figure 15C In an embodiment of the applicator, one or more of the plurality of layers comprises a label, wherein the label comprises W zone identifiers, wherein each of the W zone identifiers is disposed on one of the W zones. These zones are labeled 1 through 6 and correspond to zones / areas 1 through 6 displayed in the GUI 2800. In some embodiments, W ranges from 2 to 16. Figure 15C The W in the figure stands for six, as shown on the applicator label.

[0410] Figure 28A and 28B Depicted are apparatus for use with an applicator, such as a Figure 15C A graphical user interface (GUI) is used in conjunction with the system of the applicator shown in FIG. Figure...

Claims

1. A radio frequency-based processing system comprising: A flexible applicator, comprising: Internal areas; and a plurality of layers, the plurality of layers comprising a first dielectric layer, a second dielectric layer, and a conductive layer, wherein the conductive layer is sandwiched between the first dielectric layer and the second dielectric layer, The flexible applicator is configured to conform to a curved tissue surface, the plurality of layers defining a plurality of cutouts and a plurality of strain relief elements, each cutout having an opening extending outwardly from the interior region, Each strain relief element is an aperture extending through and defined by the plurality of layers, each of the two or more cutouts defining a gap between two of the N regions extending from one of the plurality of strain relief elements; wherein the plurality of cuts divide the applicator into N regions extending from the interior region, each of the N regions being separated from another by one or more cuts, the N regions defining a perimeter having the gaps therein, each gap being part of a cut.

2. The RF-based processing system of claim 1, wherein N is in the range of 2 to 12.

3. The RF-based processing system of claim 1, wherein the inner region is a non-cut region, wherein N is 6. 4 . The RF-based processing system of claim 1 , wherein the N regions include a first region and a second region, wherein each of the first region and the second region defines substantially the same one or more segments, boundaries, or cutouts.

5. The RF-based processing system of claim 1 , wherein the plurality of layers comprises a label, wherein the label comprises N region identifiers, wherein each of the N region identifiers is disposed on one of the N regions.

6. The radio frequency based treatment system of claim 1, wherein the applicator defines an applicator shape, wherein the applicator shape is selected from the group consisting of: oval, circular, and combinations thereof.

7. The RF-based processing system of claim 1 , wherein the conductive layer comprises a patterned region of copper traces in each of the N regions, wherein each of the patterned regions has one or more copper traces in electrical communication with copper traces arranged along the interior region.

8. The radio frequency based treatment system of claim 1, wherein the applicator further comprises an electrical connector in electrical communication with one or more addressable regions of the conductive layer.

9. The RF-based processing system of claim 8, further comprising a RF processing system comprising a RF generator having an operating frequency in the range of 0.5 MHz to 10 MHz, wherein the RF generator is in electrical communication with the electrical connector.

10. The radio frequency-based treatment system of claim 7, wherein the applicator further comprises an electrical connector in electrical communication with one or more addressable regions of the conductive layer, the electrical connector comprising a plurality of electrical contacts, wherein the copper traces arranged along the interior region are in electrical communication with the electrical contacts.

11. The RF-based processing system of claim 10, wherein the copper traces arranged along the interior region are arranged in a series of three or more adjacent segments that increase in width in a direction toward the electrical connector.

12. The RF-based processing system of claim 1 , wherein the conductive layer comprises a continuous copper sheet, and wherein each of the N regions further comprises: a first region of dielectric material having a first thickness and a first area; and second regions of dielectric material having a second thickness and a second area, wherein the area of ​​each region is greater than the first area disposed therein, wherein each first area is greater than each second area.

13. The RF-based processing system of claim 8 , further comprising an RF processing system, the RF processing system comprising an interface device in communication with the RF processing system, the interface device comprising a clamp and a cable adapter, wherein the clamp opens and closes to releasably connect and align the electrical connector, and wherein the cable adapter is in electrical communication with electrical contacts of the clamp.

14. The radio frequency based treatment system of claim 1, wherein the area of ​​the electrode is in the range of 50 cm 2 Up to 600cm 2 .

15. The RF-based processing system of claim 1, further comprising a thermal shield, wherein the conductive layer comprises an arrangement of electrical traces, wherein the thermal shield covers a portion of the interior region beneath which an adjacent electrical trace spans the portion.

16. The RF-based processing system of claim 1, wherein each of the N regions comprises one or more temperature sensors.

17. The RF-based treatment system of claim 16, further comprising an RF treatment system in electrical communication with the applicator and each temperature sensor, and further comprising a control system, wherein the control system selectively addresses each of the N zones according to one or more patterns to sequentially transmit RF energy to promote uniform heating.

18. The RF-based treatment system of claim 16, further comprising a RF treatment system in electrical communication with the applicator and each temperature sensor, and further comprising a control system, wherein when one or more of the N regions are positioned over a sensitive tissue region, the control system selectively bypasses one or more of the N regions positioned over the sensitive tissue region in response to an operator selection.

19. The radio frequency based treatment system of claim 1, wherein the plurality of layers further comprises one or more adhesive layers, polyamide layers, and aqueous gel layers.

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