CN113543739A

CN113543739A - Non-invasive, uniform and non-uniform RF methods and system-related applications

Info

Publication number: CN113543739A
Application number: CN201980093152.1A
Authority: CN
Inventors: J·M·特里恩; D·B·马斯; J·博尔; J·西蒙; D·索南什恩; S·布鲁斯
Original assignee: Saino Show LLC
Current assignee: Saino Show LLC; Cynosure LLC
Priority date: 2019-01-02
Filing date: 2019-12-30
Publication date: 2021-10-22
Also published as: AU2019419411A1; CA3125664A1; SG11202107086UA; WO2020142470A1; EP3905978A1; KR20210110853A

Abstract

Systems and methods for treating skin or other target tissue of a patient with RF energy are provided herein. In various aspects, the methods and systems described herein may provide RF-based treatment in which RF energy may be selectively controlled to promote heating uniformity during one or more of a slimming treatment (lipolysis), a skin tightening treatment (relaxation improvement), a cellulite treatment, all as non-limiting examples. In various aspects, a system may include: a flexible applicator comprising a 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 cutouts; an inner region and N regions extending from the inner region, wherein the plurality of cuts divide the applicator into the N regions.

Description

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

RELATED APPLICATIONS

This application is a continuation-in-part application of U.S. patent application No.16/238,483 filed on

day

1, 2, 2019, a continuation-in-part application of U.S. patent application No.15/640,710 filed on

day

3, 7, 2017, claiming the benefit of priority of U.S. provisional application No.62/357,920 filed on

day

1, 7, 2016 and U.S. provisional application No.62/514,778 filed on

day

2, 6, 2017, each of which is incorporated herein by reference in its entirety.

Technical Field

The present disclosure relates generally to systems and methods for treating skin (e.g., dermis and hypodermis) and other target tissue of a patient with Radio Frequency (RF) energy, including tissue located at a depth below the surface of the tissue.

Background

Electrosurgical devices are known for applying RF energy to tissue to produce various effects, including invasive procedures (e.g., for ablating, or otherwise vaporizing tissue) or minimally invasive procedures (e.g., to slightly heat the surface of the skin). However, there remains a need for improved methods and systems to provide uniform and large area RF energy application in cosmetic and/or aesthetic applications, for example, to improve the appearance of skin to make it (or look) tight/smooth and/or to reduce fat present in the subcutaneous tissue (e.g., the hypodermis).

Disclosure of Invention

Systems and methods are described herein 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 surface of the tissue with RF energy. In various aspects, the present teachings can provide a non-invasive, cooled (or non-cooled) RF-based process to implement, as non-limiting examples, one or more of: body shaping (lipolysis), skin tightening (laxity improvement), cellulite management devices, vaginal relaxation or recovery, urinary incontinence management, fecal incontinence management, and management of other genitourinary disorders.

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

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

1. user-friendly and/or hands-free (e.g., after initial setup);

2. improving patient tolerance by cooling the upper tissue layers and/or modulating RF energy and/or modulating cooling, thereby providing patient safety and/or comfort; and

3. has flexibility to accommodate various anatomical features.

As a non-limiting example, various systems and methods according to the present teachings can be used in a hands-free manner such that an RF applicator or 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., the 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 may 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 burning the skin and/or forming nodules in the tissue after thermal treatment of the tissue), to improve patient comfort, and/or to increase patient tolerance to potentially painful effects of RF energy during treatment, according to safety standards recommended by the FDA and IEC safety. In various aspects, the methods and systems described herein may be sufficiently flexible and/or conformable to enable treatment of various desired locations on a patient's body (e.g., abdomen, submental region, any of a plurality of facial regions, arms, legs), regardless of anatomical differences, different surface areas, and complex curvatures between and within the patient that may make it difficult to maintain contact within the time required to complete the treatment.

According to various aspects of the present teachings, there is provided a system for treating patient tissue, the system comprising an RF energy source and a treatment applicator having: a plurality of treatment electrodes configured to be disposed in contact with a surface of a patient's tissue (e.g., a skin surface, a mucosal surface) and to 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 further 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 treatment RF signals simultaneously applied to the at least two individually addressable treatment electrodes based on their impedances in order to maintain uniformity of heating in target tissue underlying the treatment applicator. Optionally, in some aspects, the system may further comprise a cooling mechanism for cooling a tissue surface in contact with the plurality of electrodes. In various aspects, at least one return electrode can be disposed on a surface of or within the skin (e.g., within the urethra).

In some aspects, the different RF signals applied simultaneously to the at least two individually addressable processing electrodes may include one or more of different power, pulse width, duty cycle, phase, and RF frequency. In some related aspects, the controller may be configured to reduce the power of the RF signal to an electrode of the at least two individually addressable processing electrodes that exhibits a lower impedance.

In various aspects, the at least two individually addressable processing electrodes may comprise at least two groups (e.g., clusters) of individually addressable processing electrodes, wherein each processing electrode of each group of individually addressable processing electrodes has the same RF signal applied to the processing electrode as the other processing electrodes of the group at the same time, and wherein each group of individually addressable processing electrodes is configured to have a different RF signal applied to the processing electrode at the same time.

In some aspects according to the present teachings, the system can further include a second treatment applicator configured to be disposed in contact with a tissue surface spaced apart from the tissue surface on which the first treatment applicator is disposed. In some aspects, the second treatment applicator may represent the at least one return electrode, however the return electrode may also be a separate electrode. Optionally, the second treatment applicator may include a cooling mechanism for cooling a 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 disposed in contact with 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 may, for example, be configured to activate only one of the individually addressable treatment electrodes on each of the first and second treatment applicators at a given time. Further, the controller may be configured to determine an impedance between each of the at least two individually addressable processing electrodes of the first processing applicator and each of the at least two individually addressable processing electrodes of the second processing applicator (e.g., by polling one electrode from each applicator at a time). For example, the controller may be configured to determine the impedance between each of the at least two individually addressable processing electrodes of the first processing applicator and each of the at least two individually addressable processing electrodes of the second processing applicator by: a sub-process threshold RF current is generated between the first plurality of electrodes before applying the process RF signal thereto. Additionally or alternatively, in some aspects, the controller may be configured to determine an 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 treatment RF signals to the first plurality of electrodes, so as to determine when to terminate treatment by terminating the treatment RF signals.

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

In various aspects, the controller may be configured to 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, respectively.

Methods and systems in accordance with the present teachings may provide various processes. For example, the RF processing signal may be configured to reduce skin relaxation by stimulating collagen production and/or lipolysis (e.g., by substantial heating) in adipose tissue beneath the tissue surface. For example, each electrode may be configured to deliver about 1W/cm ²To about 5W/cm²Wherein the RF signal has a pulse width greater than about 1 second. Additionally or alternatively, the RF processing signal may be configured to reduce the occurrence of cellulite. For example, each electrode can be configured to deliver a material exhibiting about 10J/cm²To about 1000J/cm²And wherein the RF signal has a pulse width of less than about 500 ms.

The cooling mechanism may have various configurations in accordance with the present teachings. For example, the cooling mechanism may 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 may 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 set target tissue region may include a temperature maintained in a range of about 42 ℃ to about 47 ℃ during a treatment time in a range of about 10 minutes to about 30 minutes below the tissue surface. In some aspects, the circulating fluid may comprise water. In various aspects, at least a portion of the fluid path of the circulating fluid may be in thermal contact with a side of the electrode that is not configured to be in contact with the tissue surface. Additionally or alternatively, at least a portion of the fluid path of the circulating fluid may be in thermal contact with the tissue surface at a location between adjacent ones of the plurality of treatment electrodes.

In various aspects, the system can further comprise 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 electrodes on a side of the applicator opposite a side of the applicator exhibiting a lowest temperature (e.g., increase the power of the treatment RF signal).

In some aspects, the RF energy source may comprise two or more individually controllable RF energy sources, each configured to operate at the same fundamental frequency, but the RF signals produced thereby may have different phases and amplitudes. In these aspects, the system can include two or more treatment applicators, each treatment applicator 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 disposed on two or more different treatment areas of the subject's body, and each of the two or more applicators can be configured to deliver a suitable amount of RF energy to each of the different treatment areas.

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

In various related aspects, the treatment electrode can be configured to deliver a therapeutic agent exhibiting about 10J/cm ²To about 500J/cm²Wherein the RF signal has a pulse width of less than about 500 ms. In some aspects, the controller may be further configured to adjust the RF signals provided to the plurality of electrodes such that a second treatment RF signal is provided to each of the plurality of electrodes simultaneously, wherein the second RF signal comprises a lower RF power and a longer pulse width relative to the RF treatment signal for selectively heating the septum. For example, the second RF processing signal may be configured to reduce skin relaxation and/or cause lipolysis (e.g., after or before selectively targeting the septum). In various aspects, the second RF processing signal may be configured such that each electrode delivers about 1W/cm simultaneously²To about 5W/cm²Wherein the RF signal has a pulse width greater than about 1 second.

According to various aspects of the present teachings, there is provided a system for treating a patient tissue, the system comprising a source of RF energy and a treatment applicator comprising a plurality of treatment electrodes configured to be disposed in contact with and deliver RF energy to a tissue surface of a patient, wherein the plurality of treatment electrodes comprises at least two individually addressable treatment electrodes to which treatment RF signals may be applied. In some aspects, the system may further comprise at least one return electrode and optionally a cooling mechanism for cooling the tissue surface in contact with the plurality of electrodes. A controller may be provided that is 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 compartment within adipose tissue A membrane while substantially avoiding heat transfer to adjacent tissue. In some aspects, each of the at least two individually addressable processing electrodes may be configured to deliver a therapeutic agent having about 10J/cm²To about 500J/cm²And wherein the RF signal has a pulse width of less than about 100 ms. Further, the controller may be further configured to adjust the RF signals provided to the plurality of electrodes such 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 septum. For example, the second RF processing signal may be configured to reduce skin relaxation and/or cause lipolysis. In certain aspects, each electrode subjected to the second RF processing signal may deliver about 1W/cm simultaneously²To about 5W/cm²Wherein the RF signal has a pulse width greater than about 1 second.

According to various aspects of the present teachings, there is provided a device for treating a female urogenital condition, the device comprising: a probe adapted for insertion into a vagina, the probe having a distal end configured to apply heat to at least a portion of a vaginal wall surface; and a plurality of Radio Frequency (RF) energy radiation treatment electrodes disposed in an array at a distal end of the probe to heat tissue in contact with or in proximity to 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 black body radiation emitted by heated tissue, or may be implemented by one or more electrodes operating as impedance measuring electrodes. Optionally, the probe may also include one or more cooling circuits to avoid overheating of the vaginal wall surface.

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 particular pattern. In various aspects, the device can further include one or more return electrodes to provide a return path for RF current from the treatment electrode. For example, the return electrode may be a drain pad (e.g., a neutral plate) adapted to be disposed on an outer surface of a patient's body (e.g., a skin surface). Alternatively, the return electrode may be provided in a urinary catheter. Alternatively, the return electrode may be implemented by one or more electrodes in the array that are ground electrodes.

In certain aspects, a fixture may also be provided to facilitate insertion of the probe and/or for holding the probe in place while inserted into a patient. For example, the fixation device may comprise a locking sleeve or balloon.

According to various aspects of the present teachings, a method of treating a female genitourinary system disorder is provided. For example, in various aspects, there is provided a method of managing Stress Urinary Incontinence (SUI), the method comprising: a controlled amount of heat is delivered to the vaginal wall surface to remodel tissue in a target region adjacent the bladder neck or urethra of a patient. 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 region. In certain exemplary aspects, the treatment electrode may comprise an electrode array carried by a probe, the method further comprising: the probe is inserted into the patient such that the 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 may be varied to ensure uniform heating of tissue in the target region. In some aspects, the electrode may 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 tissue between a vaginal wall surface and a urethra of the patient. For example, the method may further comprise: RF energy is delivered to heat tissue in a target area that extends to a treatment depth of about 2 to 9cm, preferably about 5 to 8cm, beyond the inner vaginal wall surface.

In some related aspects, RF energy may be delivered so as to heat tissue in the target region for a period of time, preferably less than 30 minutes, or less than 10 minutes, or in some cases less than five minutes. Further, in certain aspects, the target tissue may be heated to about 40 ℃ to 45 ℃, or about 41 ℃ to 43 ℃. Optionally, the method may comprise: cooling the vaginal wall surface before, after, or during heating of tissue in the target region.

In various aspects, the method may further comprise: the thermal effect of the RF electrode is mapped by thermal imaging or impedance measurement.

According to various aspects of the present teachings, there is provided a system for treating patient tissue, the system comprising: a source of RF energy; a treatment applicator comprising a treatment electrode configured to be disposed in contact with a tissue surface of a patient (e.g., a treatment probe configured for insertion within a vagina of a patient, the treatment probe having one or more treatment electrodes) and deliver RF energy to the tissue surface of the patient; and at least one return electrode. The system may further include a controller configured to provide an RF signal to the treatment electrode, the RF signal having a pulse duration and the treatment electrode being 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. In various aspects, the pulse duration may be less than about 100 ms. (e.g., in the range of about 5ms to about 35 ms). In various aspects, the processing electrode can have a size ranging from about 0.1mm to about 10mm, or from about 0.1mm to about 5 mm.

In various aspects, the system can further include a second treatment electrode that can be disposed adjacent to the treatment electrode, the controller is 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 processing electrode and the second electrode can be in a range from about 0.1mm to about 10mm or from about 0.5mm to about 5 mm. In some related aspects, the processing electrode may be addressed by the controller simultaneously with the second processing electrode.

In various aspects, the processing electrode may comprise a cluster of two or more electrodes, each electrode in the cluster having a dimension in a range of about 0.1mm to about 10mm, or about 0.1mm to about 5 mm. In these aspects, each electrode of the two or more electrodes in the cluster may be sized to apply a current density sufficient to ablate the tissue surface in contact with each treatment electrode in the cluster. Further, in some aspects, a second cluster of two or more electrodes may be provided, the controller configured to provide the RF signal to the second cluster, and the RF signal having a pulse duration, and each electrode of the two or more electrodes in the second cluster 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 may address the cluster and the second cluster, respectively.

According to various aspects of the present teachings, there is provided a system for treating patient tissue, the system comprising: two or more treatment applicators, each said treatment applicator adapted to be disposed on a tissue surface; and two or more separately controllable sources of RF energy. In an exemplary aspect, each of the individually controllable RF energy sources may operate at the same fundamental frequency, but the phase and amplitude of each of the two or more RF energy sources may be controllable relative to each other. In these aspects, each of the two or more treatment applicators may be associated with its own individually controllable RF energy source such that current may be shared between the two or more treatment applicators such that the two or more applicators may be placed on two or more different treatment areas of the subject's body and each of the two or more applicators is capable of delivering a suitable amount of RF energy to each of the different treatment areas. In various aspects, the system can further comprise a return electrode. Further, in certain aspects, each treatment applicator can include a plurality of treatment electrodes configured to be disposed 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 RF signals can be applied.

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

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

In various aspects, the RF-based treatment system can include a second flexible material that can be a resiliently compressible foam material. Optionally, in some aspects, the RF-based treatment system may include a fluid-based cooling device defining one or more coolant flow channels, the cooling device 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 processing system may include a cooling device including one or more connectors extending therefrom, the cooling device being sandwiched between the first support and the foam material.

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

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

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, where 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 and in electrical communication with the RF input port and the electrode array. In some aspects, the RF-based processing system may include a 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.

In various aspects, the RF-based processing system may include an output of the first control node along the RF transmission cable and a distance Y between the RF transmission cable and a connection point of the first applicator. In some aspects, the RF-based processing system may include Y ranging from about 0 to about 2 inches. In some aspects, the RF-based processing system may include Y ranging from about 0 to about 6 inches. In various aspects, the RF-based processing system can include Y ranging from about 0 to about 24 inches. In some aspects, the RF-based processing system may include a first control node including a first controller, wherein the first controller generates control signals to measure respective currents of one or more electrodes in the electrode array.

In many aspects, the RF-based treatment system can include a foam material and a rigid support, the foam material being sandwiched between the rigid support and the first support. In various aspects, the RF-based processing system, where applicable, may include a controller configured to provide RF signals to the electrode array through the RF cable, the RF signals having a pulse duration that selectively heats a septum within adipose tissue while substantially avoiding heat conduction into adjacent tissue.

In various aspects, the RF-based processing system may include an impedance tracker to monitor tissue impedance of a patient and sense and relay changes in tissue impedance of the patient to a controller during processing such that the controller may terminate the RF signal in response to the occurrence of one or more events. In some aspects, the RF-based treatment system first support may be a rigid housing. In some aspects, the RF-based processing system can include an array of K individually addressable electrodes, which can be a first array, and further include a second array, wherein the first array can be arranged relative to a processing region 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 region in a first zone, where the first and second zones can be separate portions of a patient's body.

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

According to various aspects of the present teachings, a Radio Frequency (RF) based processing system includes: a flexible applicator comprising a plurality of layers including a first dielectric layer, a second dielectric layer, and an electrically conductive layer, wherein the electrically conductive layer is sandwiched between the first and second dielectric layers, the plurality of layers defining a plurality of cutouts; and an inner region and N regions extending from the inner region, wherein the plurality of cuts divide the applicator into the N regions.

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 cuts terminate in 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 inner region is a non-cut region, wherein N is 6. Optionally, in some aspects, the plurality of N regions comprises a first region and a second region, wherein each of the first region and the second region defines one or more sections, boundaries, or cuts that are substantially the same.

In some aspects, the plurality of layers includes a label, wherein the label includes N zone identifiers, wherein each of the N zone identifiers is disposed on one of the N zones. Optionally, in some aspects, the applicator defines an applicator shape, wherein the applicator shape is selected from the group consisting of: oval, circular, substantially oval, substantially circular, pear-shaped, substantially pear-shaped, submental-shaped, and combinations thereof. Optionally, in some aspects, 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 disposed along the inner 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.

In some aspects, the system further comprises an RF processing system comprising an RF generator having an operating frequency ranging from about 0.5MHz to about 10MHz, 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 an electrically conductive layer, the electrical connector comprising a plurality of electrical contacts, wherein the copper traces disposed along the interior region are in electrical communication with the electrical contacts. Optionally, in some aspects, the copper traces arranged along the inner region are arranged in a series of three or more adjacent sections that increase in width in a direction toward the electrical connector. Optionally, in some aspects, 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 a second region of dielectric material having a second thickness and a second area, wherein each region has an area greater than a first area disposed therein, wherein each first area is greater than each second area.

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 adaptor, wherein the clamp opens and closes to releasably connect and align the electrical connector, wherein the cable adaptor is in electrical communication with the electrical contacts of the clamp. Optionally, in some aspects, the area of the electrode ranges from about 50cm²To about 600cm². Optionally, in some aspects, the system includes a thermal shield layer, wherein the electrically conductive layer comprises an arrangement of electrical traces, wherein the thermal shield layer covers a portion of the interior region below which adjacent electrical traces span and vary in density along the portion. Optionally, in some aspects, the system includes one or more temperature sensors per each of the N zones.

In some aspects, the system includes an RF processing 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 zones according to one or more patterns to deliver RF energy in a sequence to promote uniform heating. Optionally, in some aspects, the system includes an RF processing 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 selection of one or more of the N regions to be positioned over a sensitive tissue region. Optionally, in some aspects, the plurality of layers further comprises one or more adhesive layers, a polyamide layer, and a hydrogel layer.

According to various aspects of the present teachings, a method of treating tissue using an RF-based applicator, the method comprising: 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 cut and a second cut; and during the initial heating period, transmitting RF energy from each of the plurality of zones according to an alternating or sequential addressing scheme to elevate tissue below the applicator to a target temperature. Optionally, in some aspects, the method comprises: the inner spine region is shielded to avoid undesirable heating of target tissue located 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 located below one or more of the plurality of areas cannot be interrogated with RF energy. In one embodiment, the method comprises: controlling the transmission of RF energy such that one or more sensitive areas underlying one or more of the plurality of regions are cosmetically treated to enhance or induce lipolysis, skin firmness, and cellulite reduction. The method may be performed in a treatment time ranging from about 10 minutes to about 15 minutes.

While the present disclosure is directed to various aspects and embodiments, it should be understood that the various aspects and embodiments disclosed herein may be integrated, combined, or used together as a combined system, or in part as separate components, devices, and systems where appropriate. Thus, each embodiment disclosed herein may 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 may be used with any suitable tissue surface, cosmetic and medical applications, and other methods, and may be combined with other devices and systems without limitation.

These and other features of applicants' teachings are set forth herein.

Drawings

Those skilled in the art will appreciate that the drawings described below are for illustration purposes only. The drawings are not intended to limit the scope of the applicants' teachings in any way.

Fig. 1A schematically illustrates an exemplary system for providing RF treatment to various target regions of a patient's body according to various aspects of the present teachings.

FIG. 1B schematically illustrates additional exemplary aspects of the system of FIG. 1A, in accordance with various aspects of the present teachings.

Fig. 1C schematically illustrates an exemplary system for providing RF treatment to a target region of a patient's body with an electrode tip in accordance with various aspects of the present teachings.

Fig. 1D schematically illustrates another exemplary system for providing RF treatment to a target region of a patient's body using an electrode array in accordance with various aspects of the present teachings.

Fig. 1E schematically illustrates another exemplary system for providing RF treatment to a target region of a patient's body using two electrode arrays in accordance with various aspects of the present teachings.

Fig. 1F schematically illustrates another example system for providing RF treatment to a target region of a patient's body using one or more electrodes and a drain pad in accordance with various aspects of the present teachings.

Fig. 1G schematically illustrates an exemplary system for providing RF processing that includes various nodes, such as control nodes, that represent various connections and operational components of the system, in accordance with various aspects of the present teachings.

Fig. 1H schematically illustrates an exemplary arrangement of a control node suitable for use with RF-based system implementations in accordance with various aspects of the present teachings.

Fig. 1I schematically illustrates an exemplary arrangement of nodes suitable for use with RF-based system implementations in accordance with various aspects of the present teachings.

Fig. 1J schematically illustrates an exemplary arrangement of nodes suitable for use with RF-based system implementations in accordance with various aspects of the present teachings.

Fig. 1K schematically illustrates an exemplary alternative arrangement of nodes suitable for use with RF-based system embodiments in accordance with various aspects of the present teachings.

Fig. 2A schematically depicts an exemplary disposable system for providing RF treatment to a target region of a patient's body according to various aspects of the present teachings.

Fig. 2B-D schematically depict 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 aspects of the present teachings.

Fig. 2E-G schematically depict various attachable electrode arrays having the same shape customized to cover or drape various areas of a patient's skin for RF-based targeted treatment, in accordance with various aspects of the present teachings.

Fig. 2H schematically depicts a target tissue region that has been overlaid or covered by a plurality of tissue attachable electrode arrays having the same shape as part of a set or group of applicators, in accordance with aspects of the present teachings.

Fig. 3A schematically depicts an exemplary system for cooling a flexible electrode array and/or a patient's skin according to various aspects of the present teachings.

Fig. 3B-F schematically depict embodiments of various exemplary applicators suitable for treating various shapes of tissue regions in accordance with aspects of the present teachings.

Fig. 3G-H schematically depict various exemplary applicator embodiments suitable for adhering to a tissue surface when placed in contact with the tissue surface, in accordance with aspects of the present teachings.

Fig. 3I-J schematically depict various exemplary detachable applicator embodiments including disposable and reusable components, in accordance with various aspects of the present teachings.

Fig. 3K-3Q depict various images of an exemplary detachable applicator embodiment in accordance with various aspects of the present teachings.

Fig. 3R-T schematically depict various views of an exemplary rigid applicator embodiment in accordance with various aspects of the present teachings.

Fig. 3U depicts an image of an exemplary rigid applicator embodiment facing an electrode array according to various aspects of the present teachings.

Fig. 4A depicts an exemplary electrode array that may be individually addressed according to an exemplary method for monitoring and/or controlling the distribution of RF energy provided by the electrode array, in accordance with various aspects of the present teachings.

Fig. 4B schematically depicts an exemplary scan of a patient using one or more RF-based applicators to produce a tissue assessment or other output of interest, in accordance with various aspects of the present teachings.

Fig. 4C depicts RF-based tissue treatment of a patient with respect to two zones of the patient, wherein contacting the patient with an RF applicator in each such zone treats multiple tissue regions, in accordance with aspects of the present teachings.

Fig. 4D depicts RF-based tissue treatment of a patient with respect to two sections of the patient, wherein multiple tissue regions are treated using multiple applicators positioned relative to a support with respect to each such section, in accordance with aspects of the present teachings.

Fig. 5A-F schematically depict an exemplary process targeting a septum and an exemplary method for monitoring and/or controlling RF energy distribution, in accordance with various aspects of the present teachings.

Fig. 6A depicts an exemplary plot of tissue temperature of a target region including a fat region having a relatively uniform thickness during an exemplary treatment according to various aspects of the present teachings.

Fig. 6B depicts an exemplary plot of tissue temperature of a target region including a fat region having a relatively non-uniform thickness during an exemplary treatment according to various aspects of the present teachings.

Fig. 6C schematically depicts the displacement of the treatment region due to the fat region exhibiting a relatively non-uniform thickness during RF treatment.

Fig. 6D depicts an exemplary plot of tissue temperature due to displacement of a treatment region of a fat region exhibiting a relatively non-uniform thickness during RF treatment.

Fig. 6E depicts an exemplary plot of tissue temperature of a target region and correction for displacement of the treatment region during RF treatment in which the fat region exhibits a relatively non-uniform thickness in accordance with aspects of the present teachings.

Fig. 7A depicts a plot of RF power and temperature of a target area located at a depth of 1.5cm during an exemplary process, in accordance with various aspects of the present teachings.

Fig. 7B depicts a plot of tissue impedance using different cooling temperatures during the exemplary process of fig. 7A.

Fig. 7C depicts exemplary electronics for an applicator having an electrode array in accordance with various aspects of the present teachings.

Figure 8 is a schematic perspective view of a system for treating a urogenital condition according to aspects of the present teachings;

fig. 9 is a schematic perspective view of a probe and introducer in accordance with aspects of the present teachings.

FIG. 10A is a schematic illustration of the female urogenital tract;

FIG. 10B is a schematic view of the female urogenital tract showing insertion of a monitoring catheter into the urethra;

FIG. 10C is a schematic view of a female urogenital tract showing a vaginal treatment probe inserted therein, in accordance with aspects of the present teachings;

FIG. 11 is a schematic view of a probe operating in two different modes according to an exemplary aspect of the present teachings;

FIG. 12 is a schematic diagram of an RF system including exemplary electronics, in accordance with various aspects of the present teachings;

FIG. 13 depicts an exemplary phased ablation process in accordance with aspects of the present teachings;

14A-C depict results of an exemplary phased ablation process at different pulse durations in accordance with various aspects of the present teachings;

15A-15C schematically depict embodiments of various exemplary RF-based flexible applicators suitable for treating tissue, in accordance with aspects of the present teachings;

FIG. 16 schematically depicts an interface device suitable for quick connect and release applicators according to various aspects of the present teachings;

fig. 17 schematically depicts an RF-based flexible applicator embodiment including different thicknesses of dielectric material suitable for treating tissue in different regions, in accordance with aspects of the present teachings;

Fig. 18 schematically depicts various layers of an RF-based thin flexible applicator embodiment, in accordance with various aspects of the present teachings;

fig. 19A schematically depicts an exploded view of various layers and components of an RF-based flexible applicator embodiment, in accordance with various aspects of the present teachings;

19B-19C schematically depict a top perspective view of the RF-based thin flexible applicator embodiment of FIG. 19A, in accordance with aspects of the present teachings;

fig. 20A schematically depicts a top view of an RF-based flexible applicator, in accordance with various aspects of the present teachings;

fig. 20B schematically depicts a bottom view of an RF-based flexible applicator, in accordance with various aspects of the present teachings;

fig. 20C schematically depicts a view of one side of an RF-based flexible applicator, in accordance with various aspects of the present teachings;

fig. 20D schematically depicts a view of another side of an RF-based flexible applicator, in accordance with various aspects of the present teachings;

fig. 20E schematically depicts a back view of an RF-based flexible applicator, in accordance with various aspects of the present teachings;

fig. 20F schematically depicts a front view of an RF-based flexible applicator in accordance with various aspects of the present teachings;

FIGS. 21A-21F schematically depict views of the flexible applicator of FIGS. 20A-20F without a release liner, in accordance with aspects of the present teachings;

22A-22B schematically depict components of an RF-based flexible applicator showing regions of electrical traces having one or more conductive layers, in accordance with various aspects of the present teachings;

23A-23B schematically depict top and bottom views, respectively, of a flexible applicator prior to coupling with an interface device, in accordance with aspects of the present teachings;

23C-23D schematically depict the interface device in an open and closed configuration, in accordance with aspects of the present teachings;

FIG. 24A schematically depicts a top view of an interface device, according to various aspects of the present teachings;

FIG. 24B schematically depicts a top side view of one side of an interface device according to aspects of the present teachings;

FIG. 24C schematically depicts a bottom view of the interface device, in accordance with aspects of the present teachings;

FIG. 24D schematically depicts a top side view of another side of an interface device according to aspects of the present teachings;

FIG. 24E schematically depicts a front view of an interface device according to various aspects of the present teachings;

FIG. 24F schematically depicts a rear view of an interface device according to various aspects of the present teachings;

25A-25C schematically depict various dispensing arrangements suitable for use with RF-based flexible applicators and other applicators disclosed herein, in accordance with aspects of the present teachings;

Fig. 26A schematically depicts a top view of an RF-based flexible applicator for submental treatment according to various aspects of the present teachings;

fig. 26B schematically depicts a bottom view of an RF-based flexible applicator for submental treatment according to various aspects of the present teachings;

fig. 26C schematically depicts a view of one side of an RF-based flexible applicator for submental treatment according to various aspects of the present teachings;

fig. 26D schematically depicts a view of another side of an RF-based flexible applicator, in accordance with various aspects of the present teachings;

fig. 26E schematically depicts a back view of an RF-based flexible applicator in accordance with various aspects of the present teachings;

fig. 26F schematically depicts a front view of an RF-based flexible applicator in accordance with various aspects of the present teachings;

fig. 27A schematically depicts an exploded view of various layers and components of an RF-based flexible applicator embodiment for treating a submental region, in accordance with various aspects of the present teachings;

27B-27C schematically depict a top perspective view of the RF-based flexible applicator embodiment of FIG. 27A, in accordance with aspects of the present teachings; and

fig. 28A and 28B depict Graphical User Interfaces (GUIs) for use with a processing system using an applicator, showing different configurations, in accordance with various aspects of the present teachings.

Detailed Description

It should be understood that the following discussion, for purposes of clarity, will describe various aspects of embodiments of applicants' teachings while omitting certain specific details, where convenient or appropriate. For example, 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. Skilled artisans will recognize that some embodiments of applicants' teachings may not require certain specifically described details in each implementation, which are set forth herein only to facilitate a thorough understanding of the embodiments. Similarly, it will be apparent that the described embodiments may be susceptible to modification or variation in accordance with common general knowledge, without departing from the scope of the present disclosure. The following detailed description of embodiments should not be taken to limit the scope of applicants' teachings in any way.

As used herein, the terms "about" and "substantially the same" refer to a change in the number of numerical values that may occur, for example, through a measurement or processing procedure in the real world; by inadvertent errors in these procedures; occurs through variations/failures in the manufacture of electrical components; occurs through power loss; and variations that would be recognized as equivalent by those skilled in the art, provided such variations do not include known values from prior art practices. Generally, the term "about" means greater than or less than the value or range of values specified by 1/10 for the specified value, e.g., ± 10%. For example, a voltage of about +3V DC applied to the element may represent a voltage between +2.7V DC and +3.3V DC. Also, where values are referred to as "substantially the same," the values may differ by up to 5%. The quantitative values recited in the claims, whether equally modified by the term "about" or "substantially", include equivalents to the recited values, e.g., variations in the numerical values of such values that may occur but that would be recognized as equivalents by those skilled in the art.

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

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

In various aspects, the systems and methods can treat unwanted fat (e.g., via lipolysis), improve skin laxity/tightness (e.g., by stimulating collagen), improve the appearance of cellulite (e.g., by rupturing a membrane), and treat various genitourinary system disorders by applying RF energy (e.g., about 500kHz, about 0.5MHz, about 1MHz, less than about 1MHz, greater than about 1MHz, about 1.5MHz, about 2MHz, about 2.5MHz, about 3MHz, about 3.5 MHz, about 4MHz, about 4.5MHz, and 5.5MHz, or other frequencies including frequencies ranging from about 0.5MHz to about 10 MHz) delivered to a tissue surface (e.g., skin, vaginal wall, esophagus) of a patient via a treatment electrode or electrode array, which is optionally water-cooled, the RF energy propagating from the surface into deeper tissue layers and via return electrodes coupled to the tissue surface at locations remote from the treatment electrode or electrode array (e.g., a large surface area neutral pad) is returned to the RF generator. According to various aspects of the present teachings, methods are provided for heating a relatively large area (e.g., greater than about 24 cm) with RF energy by applying (e.g., placing, securing) an applicator to the skin, energizing a device (e.g., activating an RF generator), simultaneously cooling a superficial layer, and selectively controlling deposition of RF energy so as to heat tissue beneath the surface ²Is greater thanAbout 50cm²Or greater than about 200cm²) Systems and methods of target organization. According to various aspects of the present teachings, deposition of RF energy and/or cooling of tissue may be provided such that tissue beneath the surface is substantially uniformly heated. It should be appreciated in light of the present teachings that heating uniformity may be required to help provide safety, patient tolerance, and uniform clinical results.

Referring now to fig. 1A and 1B, an exemplary system 100 in accordance with various aspects of the present teachings is schematically depicted. As shown, the system 100 generally includes a console 110 and one or more applicators 130a-d, including: one or more conductive electrodes (e.g., comprised of metal) configured to be disposed in electrical contact with tissue of a patient (e.g., adjacent to a region to be treated) for application of RF energy to the tissue surface; and a return electrode (e.g., a neutral/drain pad 130e, as shown in fig. 1A, or an active electrode array 160, as shown in fig. 1B). The console 110 may have various configurations and may include a display 132 (e.g., capable of reporting and/or controlling various process parameters) and a housing 134 containing one or more

RF energy generators

135, 136, a temperature-controlled water circulator 138 (e.g., including a cooler and/or heater), and a power source 139 (e.g., a low voltage power source), all as non-limiting examples. System 100 also includes a controller 137 (e.g., including a CPU or microprocessor) for controlling the operation of

RF energy generators

135, 136, the application of RF energy to specific electrodes 162, and/or the operation of water temperature regulator/circulator 138 in accordance with the teachings herein. As shown, the console 110 may include: a plurality of ports (e.g., CH1-4) for electrical and fluid connection of the applicators 130 a-d; and an additional port for electrical connection to drain pad return 130 e. As discussed in detail below, for example, each of the applicators 130a-d may include a cooling water attachment and electrical connections to support serial communication between the console 110 and the applicators 130a-d, each connected to the console 110 via its own cable or umbilical 133.

As discussed in more detail herein with respect to fig. 1G, the length of the umbilical may also be referred to as length X. Each of the ranges described herein may apply to the length X between control node 1 and node 2 shown in fig. 1G. In one embodiment, the length of the umbilical may range from about 10 feet to about 20 feet. In one embodiment, the length of the umbilical may range from about 1 foot to about 10 feet. In one embodiment, the length of the umbilical may range from about 2 feet to about 8 feet. In one embodiment, the length of the umbilical may range from about 20 feet to about 50 feet. In one embodiment, the umbilical is greater than about 20 feet in length.

The one or

more RF generators

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

Those skilled in the art will appreciate in light of the present teachings that various parameters of the RF energy (maximum power, frequency, duty cycle, pulse duration, etc.) may be selected depending on the desired treatment and treatment region, as discussed further herein. For example, it should be understood that one or more of the plurality of

RF generators

135, 136 may be adjusted to provide various powers, including, for example, to applicators (e.g., 130a of fig. 1B) and one per applicator300W of RF energy to a return electrode (e.g., 130B of FIG. 1B) configured to have an area of about 200cm ²(about 100 cm)²x 2) or about 1.5W/cm²Wherein each

applicator

130a and 130b provides about 1.5W/cm, respectively²。

Other suitable RF energy generators may be employed, as discussed further herein, for example, by way of non-limiting example, a suitable RF energy generator may provide about 0.5W/cm²To about 5W/cm²Wattage range of (a). In various aspects, the appropriate duty cycle may vary depending on the target tissue type, however, in some exemplary tissue heating applications, the objective may be to deliver an amount of RF energy in order to cause a temperature increase while keeping the treatment time as short as possible. Thus, as the duty cycle is reduced, the RF energy may be increased to compensate for the reduced amount of "on time" so as not to extend the total processing time. An exemplary duty cycle for heating the skin and fat is 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 may be adjusted at different frequencies ranging from microseconds to seconds, because in some applications a faster adjustment period may enable more precise control, while in other applications a longer adjustment period may be desirable. The duty cycle may also be adjusted to optimize energy deposition in different tissue layers or types: anatomical regions of large volume, large depth, and highly perfused tissue target regions (e.g., fat) may allow for a relatively long duty cycle (e.g., 80% duty cycle instead of 30% duty cycle), while shallower, smaller, and poorly perfused tissue (e.g., skin) may require a relatively short duty cycle (e.g., 30% duty cycle over 80% duty cycle). Applications other than bulk heating, which rely on tissue impedance to select target tissue, can range from very short duty cycles, even <A 1% duty cycle greatly benefits. Such short duty cycles may also be characterized or referred to as pulsed RF.

As shown in fig. 1A and 1B, an exemplary system 100 may include a plurality of applicators 130a-d, representing widely adaptable stand-alone systems 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, e.g., 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 by an adhesive), may be important to maintaining patient safety and comfort. As shown, the applicators 130a-c may each include a relatively rigid or flexible applicator body, distribution electronics, a water bladder or reservoir, an electrode array, and an adhesive for assisting in securing the applicators 130a-c to the patient's skin, all as non-limiting examples. In some additional or alternative aspects, a vacuum may be used to help secure the applicator to the skin. As discussed in detail below, the applicators 130a-c can have a variety of configurations, but are generally configured to be coupled to a tissue surface of a patient such that RF energy delivered to the applicators 130a-c can be applied to the tissue of the patient through one or more electrodes disposed in contact with the tissue surface. The applicators 130a-c may also have various configurations. Additional exemplary applicator configurations are described in more detail herein.

For example, in the exemplary system 100 of fig. 1A and 1B, the applicators 130a-B may 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 may operate in a monopolar mode such that a circuit is formed by the source electrode 162a from the electrode array 160a of one applicator (e.g., 130a of fig. 1B) and the return electrode 162B from the other electrode array 160B of the other applicator (e.g., 130B of fig. 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, as best shown in fig. 1A. As discussed further herein, when tissue reaches the clinical endpoint of certain electrode arrays, other arrays may not deliver a full dose due to anatomical differences. In this case, the power consumption to the auxiliary return electrode 130e can be used to increase the relative temperature of the hysteresis position. In some alternative aspects, bipolar operation may be achieved by activating electrodes within a single applicator array (e.g., array 160a of applicators 130 a).

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

Referring now to fig. 1C-1F, electrodes of other exemplary applicators will now be described with reference to an electrosurgical unit (ESU) system 100 having a console 110 known in the art and modified in accordance with the present teachings. As shown in fig. 1C, for example, ESU 100 can be configured to focus RF power and subsequent tissue heating to an electrode tip 162d (e.g., comprising a single small area electrode) of an applicator 130d (e.g., configured to be held against a tissue surface of a patient and operated in punch mode), while a relatively large area drain pad 130e (e.g., return electrode having a surface area up to about 5000 times the surface area of the delivery tip). In this way, due to the proper distribution and/or distribution of RF power, the non-uniformity in the return path is still safe enough to avoid burns.

Referring now to fig. 1D, in some alternative aspects, ESU 100 can instead include an applicator 130a having an electrode array 160a (e.g., including a plurality of individually addressable electrodes 162a) for distributing power evenly over a large area, with drain pad 130e representing the return path. As with FIG. 1C, the surface area of the return electrode 130e relative to the processing electrode array 160a can help ensure that the RF energy is sufficiently distributed to avoid undesirable damage. However, unlike the return pad 130e shown in fig. 1C, the return pad 130e in fig. 1D is similar in surface area to the electrode array 130a, such that the benefit of large area uniformity in the return pad 130e is reduced. That is, return pads 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 processing targets with electrode arrays, as shown in fig. 1D, the size requirements of the return pad may be impractical and it may not be possible to size to connect to an untreated portion of the body (e.g., an untreated portion that is too large to connect to the body).

Furthermore, as discussed in detail below, various mechanisms according to the present teachings can be utilized to reduce "hot spots" on the active processing electrode and ensure more uniform processing. For example, as discussed in detail below, the dispensing electronics of the applicator 130a may be used to provide the same or different RF signals to the individual electrodes 162a of the electrode array 160a in order to provide improved control over the treatment procedure.

As shown in fig. 1E, in some aspects, the system 100 may instead utilize two electrode arrays disposed on different applicators: a first applicator 130a having a delivery treatment electrode array 160 a; and a second applicator 130b having a return electrode array 160b that is also used to deliver treatment energy via the electrode array. In these aspects, the return electrode array 160b can mirror the process electrode array 160a, thereby also providing process energy, and can facilitate interfacingGood uniformity is achieved for the two skin contact areas that touch the first applicator 130a and the second applicator 130 b. In some aspects, both treatment pads are about-100 cm in size²And each may deliver RF energy so as to provide uniform deep heating, while the third electrode is able to dissipate power from two treatment locations in contact with the first and

second applicators

130a and 130b if the locations are heated differently (e.g., due to perfusion, as described above with respect to fig. 1A). RF energy, current, signal or energy 159a may flow between the applicators/electrodes as shown.

As shown in fig. 1F, in some aspects, the system 100 may also utilize an applicator 130j having an electrode array 160a and another applicator 130k having an electrode 160b for use with a drain pad 130e or other drain device. The

applicators

130j, 130k may be attached via an umbilical cable 133. The

applicators

130j, 130k and the drain pad 130e may be used during an active treatment period to perform impedance mapping performed using the electrode array (130k or 130j) in communication with one or both of the second electrode array (130j or 130k) and the drain pad 130 e. As shown, RF energy, current, signal or energy 159b may flow between the applicator 130k and the drain pad 130 e.

Optionally, in some exemplary aspects, the applicators 130a-d may include one or more coupling features (e.g., clips) that allow the applicator to be clipped into a frame that attaches to a strap or the like that will wrap around the frame (and the applicator attached thereto) or attach the frame (and the applicator attached thereto) to the surface of the patient in order to provide the clinician with a connection of the device to the patient's free hands. In another embodiment, the applicators 130a-d may be attached directly to the skin surface via, for example, adhesive, gel, and/or light suction.

Although the applicator of fig. 1D-F is generally shown to include a generally planar electrode array (e.g., a rigid or flexible electrode array) or individual electrodes according to embodiments disclosed herein, in some alternative aspects, the applicator may be configured for insertion into an internal tissue site in order to apply RF energy to or to reach a depth below a mucosal surface (e.g., vaginal wall, esophageal lining wall). For example, as discussed in detail below with reference to fig. 8-12, the applicator may include a generally tubular probe that may be 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 mixed mode. Additional examples of applicators suitable for applying and directing RF energy are also discussed herein and depicted in FIGS. 15A-15C, 17, 19A-21F, 22A, 22B, 23A, 23B, 25A-25C, 26A-26F, and 27A-27C.

Mode of operation

The teachings herein include various electrical configurations, i.e., unipolar, bipolar, and hybrids thereof. A unipolar configuration includes an active electrode (or electrode array) and a passive electrode (e.g., a drain pad). A bipolar configuration includes two separate active electrodes (or two separate arrays of active electrodes). The hybrid configuration includes two separate active electrodes (or two separate arrays of active electrodes) and a passive electrode (e.g., a drain pad). The exemplary electrical configuration shown in fig. 1C and 1D is unipolar, while the electrical configuration shown in fig. 1E is bipolar. The electrode configuration shown in fig. 1A is hybrid. It should be appreciated that in the case where only the pulsing handpiece 130d and drain pad 130e as shown in fig. 1 are used, this configuration would be unipolar. On the other hand, only the electrodes that use and activate the electrode arrays on the two

applicators

130a and 130b would be in a bipolar configuration. Yet another subset of the options shown in fig. 1A using two

applicators

130a, 130b and a drain pad 130e would be a hybrid configuration.

Fig. 1G is a schematic diagram illustrating a representation of an RF-based tissue processing system 170A in accordance with the present disclosure, showing various operational and/or connectivity control nodes. Specifically, node 0, node 1, node 2, and node 3 are shown in order. By way of introduction to the specific role of a given node type, in some embodiments, node 0 may serve as the master control node. The node 1 may control and direct the transmission of various DC power signals and other signals discussed in more detail herein. In addition, node 2 may control the individual activation and deactivation of the electrodes as well as 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. A node may be interchangeably referred to as a control node or node. 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. The nodes may be considered reference points or tags corresponding to various electronic components or other components or subcomponents of a given RF-based tissue treatment implementation. Temperature measurements may be made using sensors located in applicators near the node 3. Specifically, in one embodiment, a temperature measurement is made using signals from such sensors, and a temperature measurement is obtained at node 1 or node 2.

In addition, each of these nodes (node 0-node 3) may also be used as a class or grouping, such that each of these four nodes has other nodes grouped with it. For example, in FIG. 1H, node 0 may have multiple other nodes 0. As shown, node 0 may have nodes 0 through n, where node k is labeled as an example node. Node k, which is a node level 0 node, then communicates with several node type 1 nodes labeled 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 may 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 node set of node 0 type is n. In some embodiments, the number of nodes per node type may be greater or less than n. For example, there may be one node 0 and twenty nodes of the type of

node

1, 2 or 3. In general, the number of nodes per node type may be any positive integer greater than or equal to 1.

Referring back to fig. 1G, each node may have a node located within or connected to another node. Starting at node 0, this node corresponds to the RF driver platform for a given RF processing system implementation. Node 2 is responsible for turning on/off the various 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 separate commands to other nodes or sub-nodes. The RF driver platform (node 0) may be implemented using one or more logic devices, FPGAs, circuits, circuit elements, or a combination thereof. The nodes may be connected using one or more electrical connections 171, which may include one or more cables, buses, or other electrical signal connections and transmission mechanisms.

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

Still referring to fig. 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, clock generator, or other means 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 source, an AC power source, a connection 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 console described herein. Coolant flow path 172 extending from node 0 is also shown consistent with an embodiment having node 0 within console 110. In general, coolant flow path 172, also shown in dashed lines, may begin at any one node or be connected to an applicator from a different source, relative to the electrical connections shown in solid lines between node 0, node 1, and node 2.

Node 0 controls the timing of all other nodes in the system, such as node 1, node 2, and node 3, as well as the child nodes in each of these node types or classes. This may be performed using one or more timing components 173. Thus, node 0 may facilitate serial communication with other downstream nodes (such as type 1, type 2, and type 3 nodes) over an active RF processing line. In turn, the node configuration facilitates phase control of various nodes and sub-nodes in electrical communication with node 0, either alone or in conjunction with the use of serial communication signals. In one embodiment, the system drives the serial communication length synchronously with the fundamental RF frequency. Given that the phase angles of the various waveforms may vary over time, the timing control provided by node 0 and the timing component support the assignment of a given phase on a signal-by-signal basis. This, in turn, 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.

The RF-based processing systems described and depicted herein (including those described with respect to fig. 1H-K, including node 0 and any child nodes thereof) are designed to phase node 1 and any child nodes of the node 1 category. Node 0 may output one or more signals having a set phase or phase relationship. In one embodiment, node 1 is disposed in, near or around an RF generator.

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, triangular wave, square wave, chirp, sawtooth, etc.) of the RF drive signal, as well as other signal parameters.

There may be any one of a plurality of these nodes in the generator (e.g., one per applicator, multiple nodes per applicator, or multiple applicators per node). These node 1 nodes (or child nodes) are labeled 1.1, 1.2, 1.3 …. n, etc., as shown in fig. 1H-K. As with node 0 and other nodes described and depicted herein, node 1 may serve as a class or node type for all nodes that are part of or perform the operation or function of the RF generator. The use of child nodes is only to convey the idea that child nodes are a type of node, but each child node is itself a node that can be connected to other nodes. The hierarchy of nodes is not limiting, and any given node of a particular function, electrode connection, applicator connection, etc. may define another node category to group nodes with similar functions and/or connections together. Thus, a node may be, but is not limited to being, mapped to one or more applicators, and vice versa.

As noted herein, node 0 may facilitate serial communication over an active RF processing line with other control nodes or other components to which it is connected. In addition, differential serial communication between node 1 and node 2 may be accomplished using twisted pair conductors, as shown in node-based system 170C depicted in fig. 1J. As shown, an exemplary node 1.1 of node 1 is connected to node 2 by one or more twisted pair conductors. In turn, as shown, each node 2 is connected to one of the nodes 3. The limited number of twisted pairs (e.g., 1 to 20 twisted pairs) delivering RF power and control signals to the distribution electronics (node 2) allows for no practical limitation on the length of the electrical connection 171 between

nodes

1 and 2, and the twist pattern increases noise immunity, thereby reducing the likelihood of contaminating the control signal integrity.

Furthermore, keeping the distributed electronics (node 2) away from the platform (node 0) and close to the applicator's electrode (node 3) can improve the fidelity of controlling and reading each electrode. Long lead lengths from the distributed electronics to the individual electrodes can obscure control of the individual electrodes by promoting cross talk between the individual channels and reducing the performance of the mapping and processing capabilities of the architecture. In this way, controlling the length of the wire may improve the performance of the mapping and processing.

In various embodiments, node 1 has one or more outputs. This can be seen in node configuration 170B shown in fig. 1I. The output of node 1 includes: one or more main RF drive signals to power the electrodes for processing; communication signals or data between node 1 and node 2; and a DC power supply to power node 2. In one embodiment, node 1 provides isolation/electrical safety to the patient to prevent any dangerous currents from reaching the patient. In one embodiment, node 1 is configured to prevent the transmission of any harmful alternating current. In one embodiment, the node connections shown in FIG. 1I are configured for a typical processing scheme using RF energy.

Each individual node 1 sub-node (1.1, 1.2, 1.3,. 1.m) may be individually phased such that one or more or all output signals from node 1 are set to have all of the following before transmitting such signals to node 2: the same phase, different phases, or phases between node subsets. As shown in fig. 1I, each node of node 1 type, node 1.1, 1.2, 1.3, 1.4,. 1.m, is connected to a node of node 2 type in a 1-to-1 manner. In turn, each node in the node 2 node group (node 1.1.1.. 1.n.1) branches into a plurality of node 3 type nodes.

Specifically, as shown in FIG. 1I, each node in the node 2 group is connected or mapped to n nodes in the node 3 group. Thus, 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 eventually all n nodes at node 2 are each connected to n nodes at node 3. The network topology for this hierarchical mapping is in the form of 1 to all n, one to n each, and n to all n moving from left to right from node 0 to node 3.

Node 2 is responsible for turning on/off the various 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. In contrast to FIG. 1I, FIG. 1K shows an alternative configuration of node 170D, where each node 0 is connected to n nodes of the type node 1. All n node 1 nodes are then 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 in the form of 1 to all n, all n to only 1 n, and only 1 n to all n.

Based on the node connection arrangement of the node-based control system 170D in fig. 1K, such local measurements cannot be performed at node 1, but are measured at node 2. This is because node 2 connects each node of the node 2 level to a set of electrode groupings in the applicator such that all node 2 nodes interface with all electrode nodes at the applicator (node 3). The ability of the node 2 node to measure individual currents facilitates impedance mapping and individual addressing of electrodes in an electrode array.

Logic elements (such as FPGAs, ASICs, circuits, and combinations thereof) are selected and arranged so that node 1 can individually set all phase values of signals output from node 1 to other nodes (such as node 2 and node 3) and sub-nodes of each thereof. This is advantageous because it widens the range of processing options and RF profiles that can be implemented at the electrode array of node 3. In particular, node 1 may be selectively phased in different configurations because of the timing that may be based on the selected node, the phase of each node, and the start of phasing or waveform propagation from or to each node.

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

All nodes are phased in one phase, as follows: 1.1, 1.2, 1.3, …. n.

Separate phasing nodes, as follows: phase node 1.1 then phase node 1.7 then phase node 1.2 then phase node 1.16 then phase node 1.1 then phase node 1.2 then phase node 1.3 then phase node 1. n.

Nodes are phased 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.

The foregoing are examples only, 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 a different phased sequence or order, or a combination thereof. This flexibility of all phasing together, individually, in clusters, etc. enables one to adjust the treatment according to the contour of the patient tissue undergoing treatment, and enables one to adjust the treatment according to the user's position. In general, 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 a first node, a second node, a third node, or a fourth node.

Cable/umbilical

As described herein with respect to fig. 1A, the 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 implementation to the applicator and one or more of the various control node electrical connections may be routed through the umbilical cord housing to secure the signal transmission conductors. In one embodiment, one or more sections of such an umbilical may house the RF transmission cable, sections thereof, and tubes or flow paths for circulating coolant to a given applicator.

In one embodiment, the length of the RF transmission cable, or the length of its sections or conductor segments between various control nodes, or a subset or combination of the foregoing should be selected to support operation of the RF-based system described herein. In one embodiment, the present disclosure relates to various operating lengths for various electrical conductor lengths used in systems supporting their operation. 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 desired efficiency and effectiveness. Some examples of these length parameters can be seen by reference to fig. 1G.

As shown in fig. 1G, the distance between node 1 and node 2 is identified as length X. This length X may correspond to the length of the umbilical from a given console embodiment. Various suitable X-length distances are discussed herein with respect to fig. 1A. Further, the distance between node 2 and node 3 is identified as length Y. The length Y may include the length of one or more conductors, such as the plurality of conductors used in RF transmission cables. The length Y may be less than the flow path of coolant from the node 2 through the applicator. The length Y may be measured from the output of the node 2 to the input of the applicator. Further, the length Y may include traces or wires that extend into the applicator and terminate at a given electrode. Length Y may also include the average distance between the various conductors within the applicator and each electrode, and the entry point of such conductors into the applicator plus the length of such conductors between the output of node 2 and the input of node 3. The input of node 3 may include an opening or passage for a conductor from node 2 to enter the applicator. Generally, the distance or length Y is the distance outside the node 2 from the output of the node 2 to the start of the applicator.

The length or distance of distance Y is selected to be important for successful operation of a given applicator-based RF treatment system in order for the overall system to function well at all required capacities. The selection of length Y preserves the electrode activation and deactivation function of node 2 and the current measurement function of node 2, and thus it facilitates impedance mapping and other derivative functions. As part of design work and node-based conductor configurations, it has been determined that Y ranges from about 0 inches to about 2 inches in one embodiment. This specification of the Y-distance supports a system configuration that can avoid wires or other conductors and use 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 a PCB. In yet another embodiment, the distance Y ranges from about 0 to about 6 inches. In yet another embodiment, the distance Y ranges from about 0 to about 1 foot. Alternatively, the distance Y may range from about 1 foot to 2 feet. In other embodiments, Y is less than about 3 feet.

From the foregoing discussion of exemplary systems and descriptions of various electrode configurations and arrangements, it is beneficial to consider additional details relating to various processing parameters and other features of the present disclosure. As will be appreciated by those skilled in the art in light of the present teachings, the exemplary system may provide the following benefits and/or include some or all of the following features:

treatment temperature and cooling of patient skin

In various aspects, it may be important to administer uniformity of delivered RF energy in order to safely elevate the target tissue to a desired temperature. In particular, to provide an effective treatment, it may be important to elevate the target tissue to a desired temperature range, but also to maintain the tissue in the target region at the elevated target temperature for a given duration. That is, the "time at temperature" may be important to impart the desired clinical benefit. For example, the temperature within the adipose layer may range between about 39 ℃ to about 47 ℃, or between about 39 ℃ to about 44 ℃, or between about 42 ℃ to about 47 ℃, with about 41 ℃ to about 42 ℃ providing a typical tissue temperature for treating tissue within the adipose layer or other similar tissue located at a depth. In some aspects, a temperature range of about 41 ℃ to about 42 ℃ may be used to preferentially stimulate collagen development. Higher temperatures up to about 46-47 ℃ may be used to target more damaged tissue, thereby providing more aggressive treatment, for example, in deeper tissue layers. However, the range of 46-47 ℃ may not be tolerated directly on the skin surface because the patient experiences an uncomfortable sensation of a relatively high temperature. In some aspects, the treatment temperature of the submucosal tissue can be capable of withstanding higher temperatures, up to about 70 ℃, or about 40 ℃ to about 60 ℃. The treatment time at a temperature may range from about 5 minutes to about 25 minutes and may vary with, for example, the depth or volume of the target tissue. Accordingly, it may be important to actively control the RF energy as otherwise discussed herein to distribute through the target tissue in the target treatment zone substantially uniformly, predictably, and automatically (without user intervention) in a substantially homogeneous manner. In some embodiments, the tissue surface temperature (e.g., skin surface and/or mucosal tissue surface) may be controlled to remain within a range of about 15 ℃ to about 40 ℃, or about 25 ℃ to about 40 ℃, during treatment of tissue at a depth. Due to the temperature control at the skin surface ranging from about 15 ℃ to about 40 ℃ or from about 25 ℃ to about 40 ℃, it can be tolerated during treatment to achieve a higher temperature range at a depth (e.g., from about 46-47 ℃).

Cooling the skin surface of the patient protects the epidermis and improves patient comfort. Sufficient surface cooling (e.g., cooling water to a temperature of about 10 ℃ to about 40 ℃, or about 25 ℃ to about 35 ℃) may allow for the safe and comfortable application of higher RF power than would be the case without such cooling. This may be important because most of the target tissue is located at a depth from the surface so that surface cooling serves to protect the untargeted intervening tissue layer.

As discussed below, the electrode array may have various configurations, but in some exemplary aspects, the electrode array may be attached to an applicator that includes a metal coolant housing (e.g., bonded or adhered via an adhesive). According to various aspects of the present teachings, an electrically insulating and thermally conductive layer (Kapton or ceramic, AlO)₂Etc.) may be located between a cooling housing (e.g., a reservoir or pouch containing temperature controlled cooling water) and the electrode array such that the cooling water cools the electrode array and the skin surface of the patient. As described above, cooling water may be circulated from the console 110 of fig. 1A and 1B via one or more pumps through one or more fluid conduits (e.g., to respective applicators connected thereto via one or more umbilicals 133), wherein the cooler/heater 138 is configured to detect and/or maintain the temperature of the cooling water as desired.

RF pulse duration for target tissue selected for treatment

According to various aspects of the present teachings, various processing schemes may be provided. In various aspects, long duration (e.g., greater than 1 second, CW) low power RF energy (e.g., can be expected depending on biological target selection and biological target treatmentE.g., about 1W/cm²To about 5W/cm²) Protocol and short duration (e.g., less than 500ms, or less than 100ms) high energy RF pulses (e.g., about 10 to about 1000J/cm per pulse²、10J/cm²-500 J/cm²、10J/cm²-300 J/cm²、10J/cm²-100 J/cm²) Schemes, and the two schemes may provide different benefits. Without being bound by any particular theory, the method of action may be thermal in nature, with the delivered RF power serving to primarily or preferentially heat (or even coagulate) the selected tissue. Thermal diffusion or conduction of adjacent tissue is also contemplated as a treatment regimen. More specifically, because different tissues have different electrical impedances and RF energy tends to propagate through anatomical structures or tissues that exhibit the lowest impedance, connective tissue (e.g., fibrous septal tissue that interpenetrates the fatty layers) may represent a preferential path of relatively low impedance through which RF will be conducted. Thus, heat will tend to accumulate in the relatively low impedance RF conduction path. For example, connective fibers of septal tissue will begin to heat up relative to adjacent tissue. As 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, which has a relatively high electrical impedance compared to connective fibers (e.g., septal tissue), for example. It will be appreciated in light of the present teachings that the pulse duration of the applied RF may thus provide a method of selecting anatomical target tissue, as discussed in detail below.

Short duration high power RF pulses can be used to heat or even coagulate low impedance tissue (e.g., connective fibers of septal tissue), while long duration low power RF energy tends to heat low impedance tissue at a rate that is slow enough for heat to be conducted into adjacent high electrical impedance tissue (e.g., fat). For example, by applying RF energy in short duration high power pulses, the fibrotic structure can be heated quickly, without conducting heat quickly enough into adjacent higher electrical resistance tissue (e.g., fat) to dissipate the heat that builds up rapidly within the fibrotic tissue. Short pulse duration high amplitude RF power can thus be within the treatment area (upon application ofBelow the device) the deposition temperature in the tissue with low electrical impedance rises. Short duration (e.g., about 10ms to about 500ms, preferably<100ms) and high amplitude RF pulse energy (e.g., about 10 to 1000J/cm²) May be used to selectively treat low impedance tissue, such as septa or other fibrotic structures within patient tissue. This rapid delivery of short duration RF treatment pulses serves to preferentially build up temperature elevation in fibrous connective tissue structures (such as the septum) because the bulk of the current will flow through the fibrotic structures located in, for example, the more resistive, higher impedance adipose layers. Given the short duration of the RF pulse, the rapidly heated fibrotic structure cannot conduct heat quickly enough into the adjacent, higher electrical resistance tissue (e.g., fat) to counteract the rapid build-up of the fibrotic tissue temperature increase. Thus, this pulse duration effect can be used to "select" the fibrous tissue or membrane to be treated by the build-up of temperature elevation, while the surrounding tissue remains relatively cool. This method can be used to selectively heat a fibrotic structure, such as a septum (the main component of cellulite that gives rise to a cheese-like or dimple-like appearance). This method can be used to coagulate fibrotic structures in tissue, such as membranes. Although the example of a septum and surrounding fat is used, the ability to target or "select" tissue having different electrical impedance may be applied to many other tissue types or layers.

On the other hand, relatively longer duration lower power RF energy may preferentially (more or less uniformly) heat tissue layers exhibiting different electrical impedance. That is, longer pulse durations and even CW (continuous RF emission) may be used to treat all tissue types within the treatment region, as the low impedance connective/fibrotic tissue or membrane is heated sufficiently slowly to allow heat to be transferred via thermal diffusion and/or conduction into the surrounding relatively high impedance tissue. Thus, the result is that all tissue within the treatment area (e.g., below the electrode array applicator) can be heated in more or less large quantities. Thus, RF power having a relatively low amplitude (e.g., about 1 to about 5W/cm)²) Long pulse durations or CW transmissions (about 1 second to Continuous (CW)) may be used to treat homogenouslyA mass or zone of tissue regardless of the composition of the tissue within the zone and its differing electrical impedance of the tissue. Long pulse duration low amplitude RF power tends to produce a temperature increase in all tissue in the target region by thermal conduction, regardless of electrical impedance. Because adipocytes have lower damage tolerance (high temperature tolerance) than connective fibers, adipocytes can be lysed while connective tissue remains substantially intact. Thus, the present teachings provide, for example, a method of lipolysis by providing low amplitude, long pulse duration (or CW) heating of the connective fibers (septa) followed by heating of adjacent fat cells. It will be further appreciated in light of the present teachings that the pulse duration can be fine tuned to optimize temperature build-up in the desired target tissue while protecting surrounding tissue from exposure to excessive temperature increases.

Electrode array

In various aspects, a large electrode face (e.g., an electrode pad) may be divided into an insert of smaller electrodes (e.g., an array of multiple individual electrodes). The electrode array can have a variety of configurations, but is generally configured such that a plurality of electrodes comprising the array can be placed in electrical contact with tissue to provide RF energy to the tissue. The individual electrodes making up the electrode array may exhibit a variety of electrode numbers and have a variety of shapes, sizes, and layouts (e.g., pitch). By way of non-limiting example, suitable individual electrodes may each have a diameter ranging from about 3mm to about 100mm, from about 10mm to about 70mm, from about 10mm to about 30 mm. In one embodiment, for example, the diameter of each individual electrode of a given electrode array may measure about 1 cm. In some aspects, an electrode array or a group of electrodes in a plurality of electrode arrays may be arranged to have an area of about 1cm²To about 500cm²The pattern of (2). The electrode array may be formed in a shape such as a hexagon, rectangle, circle, oval, diamond, trapezoid, or other shape that is adapted to the target specific tissue region to be treated. The number of individual electrodes in a single electrode array may also vary. In some aspects, for example, there may be from about 2 to about 100 individual electrodes in an electrode array, while In another embodiment, there may be from about 6 to about 20 individual electrodes in the electrode array. In one non-limiting example, 19 individual electrodes are arranged to cover about 20cm²A hexagonal pattern of surface area. Larger areas of tissue can be treated by providing several applicators or electrode sets (e.g., several electrode arrays) that cover the desired tissue surface area.

Individually switched electrode array

It will be appreciated in light of the present teachings that by dividing the 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 may be individually addressed and activated based on tissue feedback (including temperature and/or impedance feedback), e.g., as discussed further below. In some aspects, for example, only one electrode (or a subset of the electrode array) may be activated based on tissue feedback to help provide substantially uniform heating of tissue. In other aspects, controlling the electrodes individually may help ensure or control that the heating zone remains centered within the desired treatment zone location (e.g., below the electrode array applicator), as well as maintain substantial homogeneity and consistency of temperature rise within the desired treatment zone, regardless of potential tissue electrical impedance changes of the patient, and regardless of nearby or adjacent anatomical structures.

For example, the distributed electronics of the applicators 130a-d of the system 100 of fig. 1A and 1B can be used to provide the same or different RF signals to the individual electrodes of the electrode array 160 in order to provide improved control over the treatment procedure, e.g., 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 may be independently addressed (e.g., switched to gate the RF power or duty cycle applied thereto), where each individual "channel" is also capable of providing current, voltage, and/or phase angle feedback information that may be used to calculate the power and impedance of the individual electrodes. In some aspects, the independently switched electrodes in the array may be switched (e.g., via controller 137) to simultaneously gate RF power to each individual electrode in the array, or alternatively, the independently switched patient-contacting electrodes in the array may be switched to sequentially gate RF power first to one electrode in the array and then to another electrode in the array until all or substantially all of the electrodes in the array have been addressed (e.g., during impedance mapping discussed below).

In some aspects, an array of individually controlled RF electrodes may be employed to disrupt connective tissue that interpenetrates the adipose layer (e.g., to disrupt the fibroseptal tissue present in cellulite via the septal membrane). In such exemplary aspects, the electrode array may be placed over a tissue region to be treated by pulsing high energy (e.g., about 10 to about 1000J/cm) for short duration (e.g., less than 100ms)²) One electrode (or a subset of electrodes) in an array of multiple electrodes is individually addressed to target a membrane underlying the electrode array to be treated. After a short pulse or series of pulses is completed by a first electrode (or subset of electrodes), another electrode or subset of electrodes in the array may be addressed with a short pulse or series of pulses, with the process repeated until multiple electrodes or all electrodes in the array have been addressed with short duration high power RF pulses in order to target all tissue regions located below the array. Alternatively, the individual electrodes are 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, such that the septal tissue is preferentially heated with relatively short pulses due to the relatively low impedance of the septal tissue. Alternatively, a larger power supply is employed, enabling the desired and/or required high levels of energy (e.g., about 10 to about 1000J/cm) ²) Gating to a single electrode, thereby preferentially targeting the septal tissue.

In another embodiment, an array of individually controlled RF electrodes may be employed to disrupt connective tissue of an interpenetrating adipose layer and provide relaxation (and/or lipolysis). For example, an RF electrode array may first be employed as described above to destroy (e.g., using relatively short pulses of high magnitude power)Rupture) a membrane in a tissue region underlying the array. That is, after each short pulse is completed by one electrode (or a subset of electrodes), another electrode or subset of electrodes in the array may be addressed with a short pulse, with the process being repeated to target all tissue regions located below the array. Thereafter, the same electrode array can be used by using relatively long low power RF pulses (e.g., about 1 to about 5W/cm)²) To heat the entire same tissue region (including septal tissue and other tissue in the region, including fat, dermis, hypodermis, dermis/hypodermis interfaces) to provide a relatively large amount of heating, for example, for lipolysis and/or relaxation processes. For example, after targeted septal tissue treatment with short pulse high power RF treatment, the RF electrode array may be used to treat the same tissue region for relaxation by: all or substantially all of the electrodes are addressed simultaneously with a relatively long pulse or series of long pulses (e.g., about 1 second to Continuous (CW)), and the exposure is for a time ranging from about 5 minutes to about 35 minutes, or about 10 minutes to about 30 minutes, or about 25 minutes to maintain the target tissue within the treatment temperature range. It should also be understood that in some aspects, the septum may be targeted by first thermally treating a tissue region via a long pulse of multiple and/or all of the RF electrodes in the array, followed by sequential application of short pulses via one (or possibly several) electrodes in the array of multiple electrodes.

Flexible electrode array

According to various aspects of the present teachings, flexible electrode arrays are contemplated, wherein the electrode arrays allow 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), with each individual electrode unit presenting, for example, about 1cm²And comprises a thin metal surface integrated on a flexible substrate. In some aspects, the individual electrodes may also be flexible (e.g., capable of bending) due to the limited thickness of the conductive material (e.g., metal) of the electrodes. Alternatively, the electrodes may comprise, for example, a woven metal (e.g., copper) cloth that itself exhibits flexibility for conforming the stackThe contour of the weave surface. Thus, the electrode array may be constituted by rows and columns of rigid or flexible electrode units arranged on a flexible substrate scaled so as to provide a substrate having a range of 1 to 100cm²The area of applicator. This flexibility allows process uniformity to be achieved on a small scale and a large scale. It is also contemplated that the array pattern of shapes may be customized such that any shape suitable for a given treatment area may be employed, for example, a boomerang shape, a rectangular shape, or a trapezoidal shape may be used for submental or chin treatment. It should be understood in light of the present teachings that many variations in shape and size are possible. Figures 2B-D and 2E-F illustrate various electrode arrays suitable for conforming to and attaching to tissue surfaces having various non-standard shapes and standard shape sets, respectively.

Disposable applicator

In some aspects, an applicator (e.g., applicator 130a of fig. 1A), or a portion thereof, may be provided as a disposable. For example, a skin-contacting portion of an applicator including a treatment electrode and a portion of a cooling catheter may be configured to be coupled to a non-disposable umbilical cord side (which couples the applicator to a console) including relatively expensive distribution electronics, which may be removably coupled (e.g., via pins) to the electrodes in the disposable portion of the applicator. The umbilical side may also contain 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, the adhesive gel may be applied to the face of the applicator that is covered by the protective sheet. The patch can be removed (e.g., torn off) and the applicator applied to the skin. Alternatively, the adhesive gel pad may be discarded after one or more treatments, while the remainder of the applicator may be reused. Alternatively, in some aspects, the entire applicator may be disposable. In these aspects, relatively expensive accessories and circuitry can be relegated to the umbilical cord side so that the cost of the disposable applicator can be minimized.

Referring now to FIG. 2A, a portion of another exemplary system for RF processing in accordance with these and other aspects of the present teachings is schematically illustrated. Fig. 2A depicts a cross-section of skin, including the dermis, hypodermis (primarily fat), and muscle layers, with the exemplary RF applicator 230 adhered to the skin surface. As discussed further herein, coolant from a console (e.g., the console 110 of fig. 1A and 1B with the temperature controlled water circulator 138) flows through a cooling line 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 cold-to-heat ratio can regulate skin surface temperature and can be used to adjust the distribution of heat within the skin to enable selection of a target treatment zone (e.g., treatment depth). Generally, less cooling of the same RF power tends to shift the heating zone toward the skin surface (e.g., to heat the dermis to tighten the skin and increase the skin thickness). If the cooling is increased, the heated zone will tend to push down on the lower tissue layer. As discussed below, short duration pulses of RF energy in combination with cooling will tend to protect the skin (e.g., prevent heating of large masses of tissue) while preferentially heating those tissues (e.g., the septum) with the lowest impedance. In this way, the adjustment of the temperature at the skin surface can be used to adjust the distribution of thermal energy in the skin.

In various aspects, the disposable applicator 230 may also be flexible as described above, and may include a tacky adhesive on the patient-facing side of the electrode, such that the flexible pad adheres to the patient surface. In certain aspects, contact with the skin surface of the patient may be through an adhesive gel. Although in some aspects the gel layer may be thermally conductive to enable cooling of the skin, the gel layer need not be electrically conductive, as most of the power coupling may be capacitive due to the high RF frequencies used. As shown in fig. 2A, for example, the disposable portion of the flexible applicator 230 can include an adhesive gel pad 263 that can be disposed between the electrode 262 applying the RF signal and the tissue surface. Further, a bladder 264 may be provided through which hot or cold water may flow, such that coupling of the disposable portion (i.e., below the dashed line) to the umbilical side of the applicator allows for the formation of a fluid pathway. As discussed below, the pouch 264 can be flexible such that the applicator 230 generally adopts the contour of the tissue surface when applied (e.g., adhered thereto). Electrodes 262 are also shown interspersed within applicator 230, where each electrode may be individually addressable in some aspects via leads, which may be electrically coupled to pins of distributed electronics provided on the umbilical side of applicator 230, for example.

In certain aspects, it may be desirable to cool the electrodes and the area around them, but it will be appreciated that, nonetheless, for certain applications, it may be effective to cool only a small portion of the applicator area. It is also shown that different amounts of energy can be applied to different electrodes depending on the underlying impedance; where the thicker the fat the higher the impedance and correspondingly more energy is deposited. The exemplary connector concept shown in fig. 2A is intended to describe at least one non-limiting disposable concept in which expensive components for accurately distributing 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).

Electrode and applicator geometry and surface coverage

Various geometries may be used for the skin/tissue contacting or skin/tissue facing areas of a given electrode array. Figures 2B-C show representations of a patient 211 that is a candidate for one or more RF-based cosmetic, medical, or other tissue surface treatments. The patient may have: a treatment area 275 to which an applicator comprising 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 semicircular applicators 277a and elongated horn-shaped applicators 277b with slightly rounded or rounded corners, have been applied. The two half pear applicators 277c may also be used to cover the abdomen or other treatment area of interest of a given patient. The

complementary applicators

277b, 277e may also be used near the edges of other dedicated non-standard applicators. The complementary applicators may be side-piece applicators located on either side of the larger main applicator. Various

complementary applicator embodiments

277b, 277e are shown. As shown in fig. 2C, the complementary applicator 277e is in close engagement with two half pear-shaped applicators 277C to cover most of the abdominal area of the patient 211.

Other non-standard applicator shapes may be used, such as a rounded wedge applicator 277f and a complementary applicator 277e that includes a curved boundary that mimics the curve of the rounded wedge applicator 277 f. In one embodiment, the primary non-standard electrode is packaged or otherwise provided with other non-standard complementary applicators that track one or more edges or boundaries of the primary non-standard applicator in order to efficiently cover or tile the treatment surface with a minimal amount of uncovered tissue in a given treatment area.

In general, when gaps exist between the electrode arrays, the gaps between the electrode arrays of the applicator can lead to irregular treatments and undesirable boundary effects, such as ridges or other anomalies caused by uneven lipolysis or other changes in tissue response. In one embodiment, the primary applicator is sized to cover a larger surface area relative to the smaller complementary applicator. In one embodiment, the range of surface area covered by a given primary applicator is about 100cm²To about 300cm². In one embodiment, the range of surface area covered by a given primary applicator is about 150cm ²To about 250cm². In one embodiment, the range of surface area covered by a given complementary applicator or side piece applicator is about 50cm²To about 100cm²。

In one embodiment, the range of surface area covered by a given complementary applicator or side piece applicator is about 70cm²To about 120cm². The above ranges may also be used to specify the area of a set of standard applicators, where each applicator in the set has the same shape.

Fig. 2E-G show representations of a patient 211 that is a candidate for one or more RF-based cosmetic, medical, or other tissue surface treatments, and various standard conformal applicators 280 in place or suitable or placed on an uncovered treatment area 275. The use of a standard applicator, such as the rectangular applicator 280 shown in fig. 2E-2G, has the advantage of being able to tile or cover a tissue treatment area without the use of special shapes that are more costly to manufacture than the non-standard applicators described with respect to fig. 2B-D. 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 electrode array of the applicator to the tissue surface. These applicators effectively fill the space of 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 a kit of standard applicators that efficiently cover the surface area required for a given treatment protocol.

Fig. 2H is a schematic illustration of a target region 285 on the surface of a patient's tissue. It may be generally desirable for the electrode array to be securable to the skin surface for various tissue types or due to other limitations imposed by patient specific parameters and the desired outcome of a particular treatment regimen. These electrodes may be placed and held in place during processing. These conformal electrodes are also of the type used in the embodiments described above with respect to fig. 2B-G. A specific example of a standard applicator shape with an electrode array is described and depicted herein with respect to fig. 2H. A variety of materials having suitable adhesive properties may be used to attach the applicator 280a to the tissue surface. In addition, the adhesive material is also tailored to release from the skin in response to manual manipulation.

To affect RF-based treatment of the target region 285, various electrode array geometries can be used that are space filling or otherwise susceptible to efficient surfacing with reduced gaps between applicators. Various specialized electrode geometries are described with respect to fig. 2B-D, and although such specific geometric designs are suitable for particular procedures and use cases, factors such as manufacturing and cost per unit may play a role when a given electrode is a single-use device.

As shown, the target region 285 has irregular boundaries. Custom electrodes for this boundary are costly to manufacture and may have limited applicability to candidates for the general population to be RF treated. Thus, in one aspect, the present disclosure relates to a kit or set 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 per given kit. K may range from 1 shape to about 20 shapes. In other embodiments, K may range from about 1 to about 10 shapes. In other embodiments, K may range from about 1 to about 5 shapes. K may also be a positive integer greater than or equal to 1 and less than 50. In one embodiment, these shapes are selected such that they are all the same shape, such as shown by square electrode 280a with dashed line boundaries. The square shape of the electrode 280a effectively tiles the area defining the processing region 285. Pairs of shapes (such as hexagons and pentagons) and other similar groupings can be used to cover an area while reducing gaps between applicator edges.

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

The electrode layer that may be used in association with the flexible cooling pouch layer 305a of fig. 3A may be any electrode array discussed additionally herein, including in association with rigid, semi-rigid, conformable, hybrid, or flexible electrode arrays as described above, for example, with reference to the systems of fig. 1A-1F and 2A and the applicators of fig. 3A-F and 3I-3X. Various cooling pouch embodiments may be integrated with different applicator designs. For a given applicator design, the pouch may 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 pouch is part of an applicator that includes a disposable portion and a reusable portion. In turn, each disposable and reusable portion may include various components and subassemblies.

Fig. 3B shows an applicator 320A, which may be implemented as a held-in-place applicator using fasteners, or which may be used with an adhesive wafer or strip and adhered to a given patient as a conformal applicator. The applicator 320A is a mixing applicator that may be combined with an attachment device or adhesive, such as a gel pad as disclosed herein. In addition to the mechanism of securing it relative to the target tissue area, the applicator 320A is also a hybrid applicator in that it may include disposable components and reusable components. When the applicator 320A is not attached to the tissue surface using adhesive, various mechanical attachment devices may be used, such as straps, clamps, bands, and other devices.

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 to include two slots to receive and slidably secure to the strap 317. This is just one possible configuration of the band 317 and applicator coupler 319. The band and coupler may have a variety of 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 laterally spaced slits 318. The slits facilitate expansion of the cylindrical shell and grip of the one or more raised

structures

340d, 340e on the applicator such that the strap can be selectively secured for removal from the applicator 320 a.

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

In one embodiment, the applicator further comprises a second support 340b disposed on or adjacent to the first support 340 a. The second support 340b may comprise 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 such that it is separable from 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 comprising a rigid or semi-rigid material forming an 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 such that the electrodes are in close proximity to or contact the tissue surface. The third support 340c and the second support 340b are designed to slide along a pre-scored line or area to appear or tear to facilitate reuse of the rigid or semi-rigid third support 340 c.

The electrode array of the applicator may be formed in or on a flexible substrate, such as by print deposition or other fabrication techniques. Such a flexible substrate may constitute one or more layers of the first support 340 a. 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 may be part of the first support 340a and extend therefrom as a tab or flexible band. As shown, the portion of the flexible substrate 350a extending from the rearward side of the applicator has a plurality of electrical contacts. Each such contact 350b is in electrical communication with one or more electrodes disposed on the tissue-facing surface of the support 340a relative to the skin contact surface applicator. In various embodiments, these contacts 350b may be electrical traces or printed electrical leads or other electrical leads.

The applicator may also include one or more cooling mechanisms 305, such as a closed-loop pouch having a plurality of flow channels, as shown in fig. 3A. As shown in fig. 3B, two fluid delivery ports 351 are shown supporting the ingress and egress of cooling fluid. During a given treatment session, water or another suitable coolant is circulated into one port 351 and out the other port 351 after circulating through a series of channels within the applicator in order to draw heat out to cool the treatment region receiving RF energy from the electrode array. Fig. 3C shows an alternative view of the applicator 320A with the port and flexible substrate 350b shown previously. The two-dimensional and three-dimensional shape of each of the first, second and third supports may vary over an almost infinite range of shapes.

Although the overall shape of the first support 340a is generally square or generally rectangular, the shape of the support and its surface may be any suitable regular or irregular shape. For example, in fig. 3D, an alternative applicator embodiment 320B is shown that includes a circular first support 340 g. Similarly, the second support 340b is also shown as having a rounded or curved shape. Furthermore, fig. 3E and 3F show two further alternative embodiments of

applicators

341a, 341b in the form of triangles and crescents, respectively. The applicator and its tissue contacting surface may comprise any suitable two-dimensional shape, including regular and irregular shapes. These shapes are shown as examples, and any suitable shape may be used in various embodiments. These embodiments may include a fluid flow path 351 for cooling the pouch and also include an electrical connector 350d, which may be a flexible substrate or include wires or other electrical conductors.

Fig. 3G shows a flexible applicator embodiment 325A. An exploded view of applicator 325A is shown in fig. 3H. The applicator 325A includes a plurality of temperature sensors 364. Suitable temperature sensors may include thermistors, but may be implemented using other means. The applicator also includes a flexible electrode 362. The electrode 362 may be an electrode array. Fig. 3G and 3H illustrate embodiments of electrodes without mapping and without cooling, which provide the opportunity to provide substantially uniform heating and flexibility to provide good uniformity to the target processing region. Although one electrode is shown in fig. 3G and 3H, 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 zones 370, which are generally disposed around the perimeter of the applicator 325A. The region 370 may include a gel or other material. The cable 368 has terminal contacts or connectors 368 a. An electrical cable 368 (such as an RF transmission cable) is attached to the applicator at a connection terminal or electrical contact 369. In one embodiment, the connector 368a of the cable 368 receives the contacts 369.

As shown in fig. 3H, the applicator 325A can include one or more coatings 361 to facilitate manufacturing or contact with the patient. These may include a plurality of gels, a gel, Kapton pad, or other materials. In the exploded view, various electrical traces or leads 365 are shown. Which are in electrical communication with the cable 368. As shown, the applicator may also include an electrically insulative and thermally conductive layer 367. The various layers of the applicators and electrode arrays described herein may include one or more electrically insulative and thermally conductive layers between the cooling device and one or more electrodes or electrical connections (e.g.,

Polyimides or ceramics, e.g. AlO₂Etc.). In various embodiments, different dielectric materials may be used to form portions of a given electrode array or otherwise be supported or disposed relative to the metal layers and conductor traces. In various embodiments, Kapton may be used as a suitable dielectric material, but other dielectric materials suitable for RF applicators for patient-oriented applications may be used.

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 patient tissue geometry (such as skin surface geometry, etc.); low thermal energy loss/dissipation factor; tissue safe, skin-friendly, biocompatible, cost effective, high temperature resistant to allow welding without damaging the material; and is robust.

Fig. 3I shows a first view of another applicator embodiment 327B with the tissue-facing surface facing downward and a second view with the tissue-facing surface facing upward such that the electrode 380 is visible. Fig. 3J shows an exploded view of the applicator 327B of fig. 3I. Applicator 327B is a mixing applicator that includes a disposable component and a reusable component. Rigid or semi-rigid housing 371 protects some components nested therein, such as printed circuit board stack 372. A rigid substrate 374 (which is typically a rigid polymer such as plastic) sandwiches the PCB stack 372 so that the stack is secured in the housing. The rigid substrate 374 may include one or more

elongated members

374m, 374n or fins extending therefrom. These members may be received by slots or

grooves

374r, 374s in PCB stack 372 or in housing 371. In one embodiment, the three components of the housing, rigid substrate and PCB stack may be considered a set of reusable elements.

A compressible or conformal substrate 376, such as a foam layer, may also be present. As shown in fig. 3J and 3N, a cooling pouch 305b is also present in some embodiments and is used to cool tissue when exposed to RF treatment. The cooling bladder 305b is connected to a fluid delivery line 377. The flexible electrode array 378 is the bottom element shown in fig. 3J. An array of 48 electrodes as part of flexible array 378 is shown in FIG. 3I. Flexible or rigid electrical traces or leads 311 may be bent around and connected to the electrode array 378, as shown in fig. 3J. The applicator 327B includes a cable 368 extending from the housing 371 that is adapted to transmit RF signals and receive impedance measurements. In part, the present disclosure relates to flexible cooling bladders that include a quick release connection (such as connection 382a shown in fig. 3N). These arrays aid in cooling and the use of quick release connectors allows for quick start and stop of the procedure. In one embodiment, various pouch designs also benefit from the disposable component.

Fig. 3K-S show images of alternative embodiments of the different components of the applicator 327B shown in fig. 3I and 3J. Fig. 3K shows a bottom view of the PCB stack 374 in combination with the foam layer 376 and the electrode array and cooling pouch 305 b. Fig. 3L shows a perspective view showing the rigid substrate 374 and the input and output 377 of the cooling bladder. The connectors of the fluid input 382a and output 382b are also shown in fig. 3L and 3N. The grooves or

slots

374s, 374r of the PCT stack 372 are shown in fig. 3M, the slots or grooves receiving members 374n, M. These slots or grooves may also be formed in housing 371 or may not be used in some embodiments.

Fig. 3O shows a top perspective view of electrode array 380 sandwiching foam layer 376 and rigid substrate 374, and exemplary electrode 381A. Fig. 3P shows the electrode array 380 and rigid substrate of fig. 3O relative to a flexible substrate 381 that forms the electrode array 380. 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 are shown formed along flexible substrate 381. These traces are also shown on either side of the foam layer 376 in fig. 3Q. The arrangement of the flexible substrate 380 with electrodes 381A as part of the array and the comfort/compressible layer 376 in combination with the substrate 374 provides the benefits of a conformal applicator while facilitating the provision of a flexible substrate array and a conformal/compressible layer while saving expensive electronic components that can be reused.

Fig. 3R-3T and 3U show

alternative applicator embodiments

333A and 333B that combine rigid electrode arrays 395a, 395B and individual electrodes 394. The housings 388a, 388b serve to protect various electronic components, such as those on the PCB stack 390. The cooling bladder 305c is also coupled to cooling inlet and outlet 377. The inlets and outlets extend from the housing at one or more channels 393. As described herein, the cable 368 provides signals and power to the array and is in electrical communication with various control nodes. These rigid applicators are particularly useful for scanning patients and generating data before and after impedance scans and other data derived therefrom. As discussed herein, various types of applicators may be used to perform RF-based tissue treatment. Furthermore, different electrode sizes may be used in a given single electrode or electrode array embodiment for each applicator.

Electrode size and spacing

The electrode size and spacing can be manipulated to achieve the desired RF deposition uniformity while maintaining flexibility and reducing electrical complexity. Having an area of about 1cm²Can provide sufficient area to safely couple RF power to the skin (e.g., without high flux) and still allow flexibility between adjacent electrodes to accommodate the contours of most anatomical structures. The size limitations of the electrode can be controlled by edge effects if the electrode itself is flexible (such as woven copper cloth), where high frequencies are concentrated at the periphery of the electrode, resulting in uneven RF deposition and hence heating. By balancing the edge effect with the thermal properties of the tissue, the electrode area can be optimized for substantially uniform heating of the skin and potentially tissue. The spacing or distance between adjacent electrodes in the array may also be optimized to heat the target area during the processing time. Suitable spacing between adjacent electrodes may range from about 0.1mm to about 2cm, for example, from about 1mm to about 1 cm. In the case of resistively coupled electrodes, suitable electrode diameter dimensions may range from about 3mm to about 20mm, or about 10 mm. In the case of capacitively coupled electrodes, suitable electrode diameter dimensions may range from about 3mm to about 200mm, or about 10 mm.

For the case of partial ablation RF treatment discussed below, for example, the size and spacing may be relatively small, ranging from about 0.1mm to about 10mm, or from about 0.5mm to about 5mm, in an electrode array, with each electrode in close proximity to each other to cover substantially all of the applicator area. Because, in the case of a partial ablation RF treatment, the pulses are too short (e.g., less than about 100ms, or about 5ms to about 35ms) to allow time for thermal diffusion between the specific tissues addressed by each electrode, while the short pulses of relatively high energy can ablate the tissues.

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

In the event of a septum breach, a short duration high power RF pulse is delivered to the target tissue, and one may use a single electrode or electrode array, and may apply the electrode to the tissue and use it in a manner that frees up hands as discussed herein, the single electrode or electrode array may be configured as a handpiece for use in a punch-out mode due to the short pulses associated with the septum breach.

Electrode cluster

In some aspects, electrode clusters (i.e., nodes comprising multiple electrodes sharing a common electrically controlled array) may be used to reduce electrical complexity while still utilizing smaller electrodes, which helps to 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 may be similarly controlled (e.g., the same RF signal) because the resolution of the thermal effect may not require more specific control, although it may be preferable to keep a large number of electrodes. For example, the electrode clusters may be used to treat connective tissue that interpenetrates the adipose layer (e.g., the fibrous septa present in cellulite) by: high power RF pulses of short duration to one electrode cluster in the electrode array and then 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 entire electrode array is availableRF energy is gated to the individual electrode clusters such that the septal tissue is preferentially heated by the relatively short pulses due to the relatively low impedance of the septal tissue. Alternatively, a larger power supply may be employed, such that a desired and/or required high level of energy per pulse (e.g., about 10 to about 1000J/cm) ²) Can be gated to individual electrode clusters to preferentially target septal tissue. As discussed further below, monitoring and/or knowing the impedance of each electrode (or most or substantially all electrodes) in real time can enable the contact integrity of each electrode (or most or substantially all electrodes) to tissue to be determined, thereby enabling inadvertent over-treatment of smaller areas than the target area to be avoided (e.g., burns can be avoided).

Patient impedance mapping

In accordance with various aspects of the present teachings, various detection and/or feedback mechanisms are contemplated to help provide improved RF processing. As discussed below, RF treatment uniformity can be facilitated by using tissue impedance mapping alone or in conjunction with surface perimeter temperature feedback. In some aspects, the tissue impedance of a patient may be "mapped" by detecting the impedance of a tissue region to be treated (or being treated) such that impedance differences may be compensated for, for example, by: the distribution of RF power delivered through each individual electrode in the electrode array (or total treatment time, or duty cycle) is controlled or modified based on information collected via impedance mapping and/or surface perimeter temperature feedback. Such impedance mapping may adjust and/or prevent heat build-up in non-target areas (e.g., outside the applicator perimeter). Such impedance mapping may adjust and/or prevent non-uniformities in the treatment region (whether due to anatomical variations or tissue layer thickness variations) and/or unintended non-uniformities in RF deposition.

In certain aspects, electrical impedance mapping of individual electrodes in an electrode array may be performed by polling the electrodes of the electrode array placed against the patient tissue surface to determine individual impedances of tissue between each electrode pair in the pair of applicators, and thus determine the impedance of the corresponding tissue beneath each electrode. For example, the mapping step may be performed at very low RF power (e.g., sub-treatment power that does not substantially raise the temperature of the tissue), with two exemplary electrode arrays disposed in contact with the tissue surface (or with different tissue surfaces). The impedance may then be detected for each combination of one electrode from one array and one electrode from the other array, for example by selectively activating the respective electrodes. After a combined tissue impedance is determined, the electrodes may be deactivated and the other electrodes "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.

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

In addition to having such mapping on an electrode-by-electrode basis, one or more applicators may be scanned over the patient's tissue to generate a baseline map or report that may include various representations showing impedance values or values derived or calculated based on such values including fat layer thickness, muscle regions, changes in tissue type, and other tissue-specific parameters (such as tissue type, hydration level, etc.). An exemplary applicator-based scan of multiple regions of a patient is shown with respect to fig. 2A and discussed in more detail herein. In addition, a multiplexed moving or fixed array may also be used to scan the treatment of mucosal tissue (such as vaginal tissue). The array can be selectively addressed so that a series of electrodes are activated to cover different tissue areas.

Thus, as discussed above in connection with fig. 1A-1F, the same or different RF signals may be provided to the individual electrodes 162a of the electrode array 160a using the distribution electronics of the applicator 130a in order to provide improved control over the treatment procedure. In some related aspects, the distributed electronics may also be controlled such that each electrode in the electrode array may be independently switched (e.g., to gate RF power to the respective electrode), with each separate channel providing current, voltage, and/or phase angle feedback information that may be used to calculate power and impedance for the respective electrode. For example, to map tissue, independently switched contact electrodes in an electrode array may be switched during an exemplary impedance mapping step to sequentially gate RF power first to one electrode in the array and then to another electrode in the array until all or substantially all of the electrodes in the array have been addressed, as described below with reference to fig. 4A. It should be noted that although fig. 4A depicts an impedance mapping step between two electrodes in two different applicators, one skilled in the art will appreciate that such description is equally applicable to any number of applicators and electrode arrays.

As schematically shown in fig. 4A, two

applicators

405a, 405b may be disposed in contact with the tissue surface, wherein each applicator comprises an

array

410a, 410b of 16 electrodes 408. With these applicators coupled to the tissue surface at the intended treatment location, an impedance mapping step may be performed prior to applying treatment RF energy (i.e., energy with sufficient power to effect treatment in the target tissue) to determine the impedance (tissue versus RF energy resistance) for each combination of one electrode 408 from applicator 405a and one electrode 408 from applicator 405 b. For example, the electrodes 408 of both applicators may be selectively activated to run very low RF currents (e.g., sub-treatment energies) from a1 to B1, a1 to B2, a1 to B3, etc., until a resistance matrix of 16x16 is generated, such that the tissue resistance between each electrode in applicator 405a and each electrode in applicator 405B is known. When the

applicators

405a, 405b are positioned adjacent to one another on the tissue as shown (e.g., as opposed to away from one another or on opposing tissue surfaces), it is generally observed that the lowest impedance will be present between the adjacent edges of the

applicators

405a, 405 b. That is, the measured resistances 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 further herein). Such observations indicate that the highest RF current and highest heating will also occur along these low impedance paths during processing.

The impedance topography revealed by this method can thus identify changes in the electrical impedance of the patient tissue, and can therefore be used to reassign or adjust the RF power and/or treatment time delivered to each discrete electrode in order to improve the uniformity of heat deposition (temperature rise), to achieve more effective fat destruction, skin tightening, collagen heating or membrane targeting, and to center the treatment zone under the applicator (e.g., electrode array), to achieve more uniform tissue temperature. For example, an individual 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 greater temperature rise) than an electrode that encounters a higher impedance. Thus, to homogenize and center the treatment zone, the impedance profile may be used to select individual electrodes at lower impedance locations to reduce RF power and/or to select individual electrodes at higher impedance locations to increase RF power. The increase or decrease in RF power delivered via individual electrodes may be proportional to the change in electrode impedance relative to the mean or average electrode power. Thus, in certain 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, independently switched contact electrodes 408 in the

arrays

410a, 410b can be switched (e.g., under the influence of the controller 137 of fig. 1A-1F) to modify the RF power provided to each individual electrode 408 to help uniformly deposit thermal energy within the processing region.

Referring again to fig. 4A, the data collected during the impedance mapping step may 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, 410 b. For example, one possible method of mitigating edge effects between electrodes 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 in order to promote more uniform spacing and more uniform heating. Alternatively, the RF power of electrodes A {4,8,12,16} and/or B {1,5,9,13} may be significantly reduced and/or permanently disabled, such as during the duration of the treatment. The second to adjacent rows of electrodes between applicators, electrodes a {3,7,11,15} and B {2,6,10,14} still have a slight tendency to carry current laterally to each other, thus heating the area under the turned-off electrodes. For example, such a pattern (e.g., produced by distributed electronics under the influence of a controller) would allow for more uniform heating under two adjacent electrodes operating in bipolar mode.

In addition, 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 such feedback, the power at each array location is adjusted accordingly and/or the endpoint of the treatment is determined. For example, during processing, the distributed electronics can be controlled such that each electrode 408 in the

electrode arrays

410a, 410b can be sampled occasionally (e.g., by gating RF power to the respective electrode), with each individual "channel" providing current, voltage, and/or phase angle feedback information that can be used to calculate power and impedance of the respective electrode. That is, the impedance mapping may also be performed in real time during the process (e.g., at intervals during the process). Ideally, the control feedback mechanism may inform the power homogenization algorithm to monitor and/or adjust the processing conditions. Such impedance mapping is particularly useful during early portions of the treatment, for example, before temperature changes have accumulated on the tissue surface adjacent to the target treatment area, which may be detected by a temperature detector as discussed in detail below. Later in the treatment, when a surface temperature rise 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 perimeter of the applicator) in order 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 surface temperature observation) is one non-limiting exemplary method. As a non-limiting example, another feedback method would be to turn to using the surface temperature feedback method after a detectable difference in surface temperature (e.g., a difference of 1/2 to 1 degrees celsius or greater) is manifested. According to various aspects of the present teachings, the RF power applied through each electrode may also be re-apportioned to achieve optimal treatment placement, optimal homogeneity, desired uniformity, and to obtain temperature information about the target tissue (e.g., skin or tissue beneath the mucosal surface) relying entirely on impedance mapping.

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

In one or more instances of time, as an alternative to moving one or more applicators over the tissue surface, a set of applicators or an electrode array may be placed on the patient and scanned by multiplexing/selectively addressing different electrodes, or by collecting impedance measurements about the tissue.

Generally, scanning a patient before and after treatment over time has various beneficial results for a user of the RF-based treatment system herein. The time measurements may be obtained during one treatment session or more treatment sessions. In some embodiments, one or more impedance maps relating to candidate tissue regions for treatment are obtained prior to the beginning of the treatment session. The pattern of left-right directional scans and up-down scans shown by arrows in fig. 4B are examples of types of scans that may be performed to identify impedance values associated with different locations on a patient and fat distributions associated therewith. The impedance value may be related to regions where more fat/high fat level HF is present relative to the same threshold and where less fat LF is present relative to the same or a different threshold. The border between the higher fat level HF and the lower or lower fat level LF is shown by the dashed line. Other indicia and representations may be displayed on the representative tissue scan. From the displayed scanning results it is clear that more treatment of the lower body and upper thighs may be required in view of the increase in fat level HF.

In this manner, a "previous" impedance map may be generated and stored for later comparison with other impedance maps over time. Such "prior" or pre-treatment impedance mapping and "post-treatment impedance mapping may be used to provide evidence of treatment effectiveness, increase and maintain patient aggressiveness in assessing the benefits of continued treatment, and also provide diagnostic information related to treatment parameters such as fat levels and fat loss over time.

Fig. 4C depicts an RF-based tissue treatment of a patient 425 with respect to two sections of the patient, wherein multiple tissue regions are undergoing treatment. Specifically, a plurality of

RF applicators

430a, 430b, 430c, 430d, and 430e are used and placed in contact with the patient. Although any suitable applicator may be used, either a conformable or rigid applicator is typical for the multi-zone process shown in fig. 4C.

Applicators

430a, 430b are positioned in a first treatment zone 1 zone comprising the upper back torso, while

applicators

430c, 430d, and 430e are positioned in a second treatment zone 2 zone comprising the upper back portion of each thigh. The illustrated applicators may be held in place with one or more attachment mechanisms, such as straps, clips, clamps, straps, fasteners, and other devices suitable for holding the applicator in a given position relative to a target treatment area of the patient 425.

Alternatively, the applicator may be adhered to the skin of each treatment area using a suitable adhesive strip, 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, 440 b. These

components

440a, 440b may include a console (such as console 110 described herein) or one or more components or subsystems of a given console 110. The applicator is in electrical 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.

Each applicator may have one or more leads and one or more cables to provide control signals, power, transmit impedance measurements, or for transmitting other electronic signals as disclosed herein. For example, each applicator may include one or more transmission cables. In one embodiment, the distance (or linear distance) of the cable section between the output of the control node 444 and the connection point of the transmission cable and the applicator 430e is S. In one embodiment, control node 444 is a controller that generates control signals to measure the respective currents of one or more electrodes of the electrode array of applicator 430 e. Each applicator used in a given embodiment may be connected, directly or indirectly, to one or more control nodes, such as

nodes

0, 1, 2, 3 disclosed herein, by other electrical means.

In one embodiment, the distance S is a target operating range suitable for maintaining the 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 power. 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, control node or nodes 444 comprise a radio frequency printed circuit board (RF PCB) stack disposed within a housing or other component, such as component 440 b. In one embodiment, each applicator depicted in fig. 4C is in electrical communication with one or more control nodes (such as a node the same as or similar to node 444).

In one embodiment, it can 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. Thus, parallel processing of different tissue regions in different parts of the body simultaneously using RF is an advantage of the present disclosure. In some cases, additional processing zones may be processed in addition to these zones. In some embodiments, each tissue region may be treated in an alternating sequence for a period of time or number of alternating iterations, the first region being active while the applicator delivers RF energy and the second region being inactive, or vice versa. Such a method may be used to the extent that such a method is most comfortable for the patient or where a particular treatment regimen benefits from a rest period or alternating RF exposure during a given RF treatment.

Fig. 4D depicts a patient 445 undergoing RF-based tissue treatment in which multiple tissue regions are treated with multiple applicators positioned relative thereto. The applicator is typically a conformable applicator that adheres or otherwise adheres to the skin. In some embodiments, other applicators may be used. In more detail, fig. 4D depicts a patient 445 undergoing RF-based tissue treatment in which multiple tissue regions are being treated in two different sections or zones of their body in zones a, B.

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 that support

distribution devices

460a, 460 b. The benefits of this configuration support that the multi-zone process shown above with respect to FIG. 4C is typical. The use of

separate distribution devices

457a, 457b in electrical communication with the

applications

450a, 450b, 450c, 450d, and 450e via cables, such as cable 462, facilitates the use of thin conformal electrodes in multi-zone processing settings.

Although any suitable applicator may be used, a conformal applicator is typical for the multi-zone process shown in fig. 4C. Given that conformal applicators can be thin, flexible sheets or stacks 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, the embodiment of fig. 4D has a conformal applicator with an array of electrodes arranged as shown, with drive electronics and other electronic components (such as one or more control nodes) disposed in

distribution devices

460a, 460b as shown.

Each

distribution device

460a, 460b may include multiple arms with 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 figures, and a fourth which is positioned on the opposite side of the device from the middle arm of each such device. 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 with respect to the various tissue treatment regions in zones a and B.

Applicators 450a, 450B are positioned in a first treatment zone a zone that includes the upper back and triceps area of each arm, while

applicators

450c, 450d, and 450e are positioned in a second treatment zone B zone that includes the lower back and upper back of each thigh. The simultaneous or alternating treatment zones depicted in fig. 4D facilitate the use of a conformal applicator that remains stationary relative to the targeted treatment area. These configurations can reduce the number of visits and improve treatment results by placing a conformal applicator over a specific tissue area. Some other benefits of selective tissue targeting are discussed in more detail below in the context of RF energy selection.

As noted above, short duration relatively high magnitude RF energy can be used to "selectively target" tissue, such as fibrotic or connective tissue, septal membranes, or even blood or lymphatic vessels, which are 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 the septum) can be monitored and tracked during the application of an RF pulse to determine changes in tissue composition in real time. For example, during RF pulse transmission, the current, voltage, and their phase relationship may be monitored in order to calculate the impedance of the tissue to which RF energy is applied. Referring now to fig. 5A-F, in various aspects of the present teachings, impedance tracking of individual electrodes and/or average impedance of array electrodes during processing may also be used to determine when to terminate the process. As noted above, for example, certain tissue types (e.g., fibrotic structures, such as membranes) typically exhibit lower impedance relative to adipose tissue. Thus, according to certain aspects of the present teachings, monitoring of impedance may indicate when those low impedance tissues have been sufficiently altered by the application of RF energy to indicate that a desired result has been achieved.

Fig. 5A represents the impedance mapping of tissue during application of an exemplary RF signal 205 intended to provide a high power RF energy pulse of 500ms, starting at time 210B as shown at the top of the figure. For example, prior to initiating the pulse at time 210B, the sub-treatment threshold low RF power between the active electrode and the drain pad (or another active electrode on the second applicator) may be utilized to determine the impedance of the native tissue as schematically depicted in fig. 5B. As discussed further herein, this relatively low impedance detected at time 210B will be understood to be representative of RF energy propagating through the untreated septum 200 depicted in fig. 5B. However, as shown in FIGS. 5A and 5C, the application of treatment RF energy after the initiation of the pulse at 210B causes the impedance of the tissue to change during heating. For example, primarily due to RF energy propagating within the septum 200 between the activation pulse at 210B and the activation pulse at time point 210C (e.g., about 300ms), the impedance measurements generally indicate that as the septum heats up and/or contracts, the impedance of the tissue between the active electrode and the drain pad (or another active electrode on the second applicator) decreases, as schematically illustrated by the reduction in length of the septum 210 of fig. 5C. For example, in some aspects, a small change in impedance (e.g., a decrease in measured impedance by a discernable amount, about 3%, greater than 3%, about 3% to about 20%, or about 10%) during the RF energy pulse may indicate a temperature increase in the diaphragm and/or indicate diaphragm shrinkage and/or tightening. As heat continues to build up in the diaphragm, the impedance suddenly increases rapidly between

times

210C and 210D, as shown in FIG. 5A.

Without being bound by any particular theory, this sharp increase in impedance may be attributed to a drastic 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). For example, referring to fig. 5D, this impedance rise may be due to rupture of the septum by RF energy, such that a 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, a sharp increase in impedance (e.g., a measurable rapid increase in impedance of about 3%, greater than 3%, about 3% to about 20%, about 10%, greater than 10%, or greater than 20%) during the RF energy pulse following the initial decrease in impedance described above can indicate that a large temperature increase in the septum causes the septum to coagulate, denature, rupture, and/or break. As shown in fig. 6A, after time 210D (e.g., about 400ms), the detected impedance remains at a relative level despite continued application of the exemplary RF pulse for its entire duration of 500ms (time 210E). Thus, it will be appreciated in light of the present teachings that by monitoring the impedance of the tissue during treatment, it can be determined whether the desired result has been achieved, and in some aspects such changes can be used to determine the end of administration (terminating the 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, the process may be terminated at time 210D (e.g., by ending a pulse or series of pulses).

In various aspects, the sampling rate of the monitored impedance (e.g., as shown by the black dots of fig. 5A) may be selected to achieve a desired fidelity of the result. For example, the sampling rate monitored may include any of a plurality of sampling times and frequencies during pulse transmission, e.g., the sampling rate monitored during RF pulse transmission may occur about 5 times, about 10 times, about 100 times, or about 1000 times.

The above description of impedance tracking during RF treatment can be used with a pulsed single electrode applicator (e.g., applicator 130D of fig. 1A) or an applicator with multiple electrodes (e.g., applicator 130a of fig. 1A, 1B, 1D, and 1D). In various aspects of applicators comprising arrays of individually addressable electrodes, after a sufficient impedance change in tissue between one electrode 562 (or cluster of electrodes) of array 560a on one applicator 530a and one electrode 562 (or cluster of electrodes) of array 560b on a second applicator 530b (as shown in fig. 5E), similar treatments can then be performed with different combinations of electrodes 562 between the two applicators (or between one applicator and the drain pad) to treat different tissue and membrane areas under the electrode array, as shown in fig. 5F.

In various aspects, electrode monitoring may also be provided to monitor the electrical condition of each electrode to satisfy an open circuit (no contact) condition in order to determine whether the electrode is in sufficient contact with tissue. In these aspects, uniform attachment of the applicator and any drift in electrical conditions 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 may be made up of many individual electrodes and the impedance at each array location may be continuously monitored, a robust electrode array automated monitoring method may be provided.

Patient surface temperature feedback:patient surface temperature peripheral feedback for RF uniformity compensation.

As noted above, various detection and/or feedback mechanisms are contemplated to help provide improved RF processing in accordance with various aspects of the present teachings. For example, as discussed above, RF process uniformity may be aided by using surface temperature feedback, alone or in conjunction with impedance mapping. 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 and/or prevent heat buildup in non-target areas (e.g., outside the applicator perimeter) or non-uniformity of the treatment zone, whether due to anatomical variations or due to tissue layer thickness variations.

In an exemplary aspect, the temperature of the patient's skin surface in the area around the perimeter of the applicator electrode array may be monitored by IR sensors, thermocouples, or the like (as non-limiting examples) in order to identify uneven heating of the skin surface area adjacent to the intended treatment area. Based on these signals (alone or in combination with impedance mapping), the controller (including the microprocessor and algorithm of fig. 1A) can provide correction factors to the RF power set points of the various electrodes in order to optimize the uniformity, homogeneity, and placement of the treatment region of the treatment.

For example, as discussed above, skin relaxation and other treatments that require substantial heating may require maintaining a "time at temperature" for a given tissue type, anatomical region, and desired treatment endpoint. By way of non-limiting example, a suitable treatment temperature range may be about 42-47 ℃ and a suitable total treatment time may range from about 10-35 minutes. However, dosimetry methods using total energy versus volume methods may not be able to identify wide variations in patient perfusion (e.g., cooling effects) or changes in thermal capacity of different tissue types (e.g., nearby or adjacent bone, viscera, and/or thick fat layers all cause changes in temperature deposition when exposed to a fixed dose of joules per volume).

Predictable RF uniformity is important for the effectiveness and safety of the applied RF treatment and may become a problem in cases where the fat layer is not uniform. However, the application of uniform RF energy (e.g., 1MHz) through the patient's skin and then into deeper tissues (e.g., the adipose layers) can be complicated by various tissue types and different impedance changes. For example, as discussed above, fibrous structures and other connective tissue have a lower impedance to RF energy relative to adipose tissue. Furthermore, the tissue layers below the fat layer (including muscles, large blood vessels, etc.) also have a much lower impedance than fat. Thus, in contrast to adipose tissue, RF energy will preferentially travel along these low impedance paths, such that the RF energy tends to preferentially heat (at least initially) these low impedance tissues before diffusing to adjacent fat cells.

In particular, an RF treatment applicator placed on a tissue surface directly above a non-uniform thickness fat layer (e.g., one side of the applicator is above a 20mm thick fat layer and the opposite side of the applicator is above a 40mm thick fat layer) can cause non-target tissue heat distribution and/or treatment non-uniformity. 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). Since RF energy will typically pass through the high impedance fat layer via the shortest path length into deeper tissue, RF energy will tend to be delivered through the 20mm thick fat layer, increasing the temperature more on that side of the applicator than on the side of the applicator for a 40mm thick fat layer. This can cause the "treatment zone" (the tissue region exposed to the elevated temperature) to drift toward the shallowest fat layer, shifting the actual treatment zone from under the applicator toward the shallowest fat layer side, an undesirable and somewhat unpredictable effect.

Such non-uniform energy distribution effects, as well as the benefits provided by various aspects of the present teachings, may be further understood with reference to fig. 6A-E. First, referring to fig. 6A, a temperature profile of a relatively uniform thickness fat layer of 40mm during treatment is depicted, with each of the multiple electrodes delivering the same RF power. In fig. 6A, the left vertical axis is the distance from the surface of the patient's skin (e.g., 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 temperature in degrees celsius. As shown, uniformity of temperature build-up in the treatment zone was observed, where the treatment zone was symmetric and located immediately below the RF energy applicator.

On the other hand, fig. 6B shows the temperature profile of the inhomogeneous fat layer during the same RF treatment as fig. 6A. In particular, the left side of fig. 6B shows a fat layer about 40mm thick, while the right side of fig. 6B has a fat layer about 20mm thick. Asymmetry and drift in treatment zone temperature away from the thicker fat layer may be observed such that the treatment zone is not located immediately below the RF energy applicator (displacement toward the thinner fat layer to the right in fig. 6B), which may be an undesirable result. Fig. 6C schematically depicts the treatment zone drift, with the vertical axis representing depth and the horizontal axis representing the distance (measured in meters) parallel to the skin surface from the center of the applicator. As shown, the zones exhibiting the target treatment temperatures are asymmetric and shifted away from the center of the applicator.

Fig. 6D depicts an exemplary temperature profile for the tissue surface based on the simulation for fig. 6B and 6C, with the left vertical axis being temperature in degrees celsius and the horizontal axis being distance from the center of the applicator (along the skin surface) measured in meters. As shown in fig. 6D, two heated lobes were observed, with each lobe being on one side of the perimeter of the applicator cooling surface. In the case where the thickness of the fat layer is uniform, the sizes of the two lobes are expected to be equal to each other. However, in this case, due to the shallower fat layer, more RF energy is deposited towards the right side of the delineated treatment area, making the lobe asymmetric. Therefore, it is an object of the present disclosure to correct and/or prevent the treated area from being uneven or the treated area from drifting from under the applicator.

In various aspects as discussed further herein, more uniform processing may be achieved by: proportionally more RF energy is delivered to the thicker fatty layer side of the applicator and proportionally less RF energy is delivered to the thinner fatty layer side of the applicator. In this exemplary case, the electrodes are an array of multiple independently switchable skin surface contact electrodes (e.g., 19 electrodes arranged in a hexagonal array for the depicted example). The electrode array may be electrically isolated from but thermally bonded to the water-cooled plate (e.g., as discussed with reference to fig. 2A and 3A). Switching the electrode array allows for uneven distribution of RF energy to the tissue to counter the tendency of the treatment zone to drift toward the thinnest fat layer. Specifically, drift may be prevented by: increasing the RF power delivered to the thicker fatty layer side of the applicator while decreasing the RF power switched to the separate electrode on the thinner fatty layer side of the applicator. This non-uniform applicator power approach forces the treatment zone to remain centered under the applicator despite variations in tissue impedance and/or fat thickness.

Fig. 6E shows that the uniformity is improved on the right side due to the re-distribution of RF power to provide a non-uniform RF power input to compensate for the non-uniform fat layer, as compared to the uniform RF power input method provided on the left side (as described above in connection with fig. 6C). The left hand image of fig. 6E, which provides uniform RF power input, produces a shift to the right of the highest temperature region that is well beyond the size of the applicator. However, the right hand image of fig. 6E provides a non-uniform RF applicator power input by which the power is adjusted to compensate for potential tissue thickness variations (e.g., as determined by impedance mapping). According to various aspects of the present teachings, the right hand image in fig. 6E depicts the highest temperature region, which is immediately adjacent to the size of the applicator, and illustrates the ability of the adjusted system to cause tissue heating to occur beneath the applicator, despite variations in tissue impedance caused by the non-uniform fat layer. For example, each independently switched electrode may operate in a closed loop with respect to power. Further, each electrode can be used as a discrete impedance detector by monitoring the delivered amps, volts, phase angle, etc. This impedance information can be used to derive a "map" of general tissue layer inhomogeneities near the applicator to provide a starting RF applicator power correction term to the control system so that individual electrodes located on high impedance regions (e.g., above the thicker fat layer) are "corrected" to add a compensatory increase in RF power. And "calibrating" the RF power to produce a uniform heat treatment zone centered under the applicator when the individual electrodes are located on a region of relatively low impedance.

The above-described tissue impedance mapping method is used to provide feedback to the control system for reassigning (adding positive and negative correction terms to the RF power commands) the RF power delivered through each individual electrode in order to control the process to remain centered under the applicator within the desired treatment zone.

Furthermore, in the case of non-uniform tissue impedance or thickness (e.g., fat layer), the resulting skin surface temperature proximate the applicator perimeter may be asymmetric with the application of a correction term to the individual electrode power or with insufficient correction applied. That is, the skin surface near the perimeter of the applicator edge on a thinner layer of fat (having a lower impedance) will tend to become hotter than the skin near the side of the applicator perimeter on a thicker layer of fat (having a higher impedance). Thus, monitoring of the increase in skin surface temperature near the periphery of the applicator can provide a useful control feedback mechanism to correct for asymmetry or drift in the intended treatment area, even when the electrode array is not compensated or is under-compensated in redistributing RF power to the individual electrodes based on the impedance map. In some aspects, separately monitoring the patient surface near the perimeter of the electrodes (a few millimeters from the edge of the cooled patient cooling block) can provide sufficient feedback to the control algorithm to reassign or correct the RF power delivered to each electrode so that the treatment zone is controlled to remain uniform and symmetric with respect to the applicator center (e.g., the treatment zone is centered under the applicator).

According to various aspects of the present teachings, the patient surface temperature outside the perimeter of the actively-cooled patient water cooling block and electrode array may thus give an indication of the tissue temperature located deeper (i.e., below the skin surface). For example, asymmetry in surface temperature around the perimeter of the applicator may indicate asymmetry or drift in the resulting "treatment zone" (the region of elevated tissue temperature that reaches the target temperature). In particular, 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, the side of a given electrode array that is overheated (or its duty cycle reduced) may be turned off to favor another portion of the same array with a lower skin surface temperature. Thus, the skin surface temperature around the perimeter of the applicator electrode array may serve as an indication that the RF power must be modified so that the temperature rise of the skin surface can be controlled to remain consistent and uniform around the applicator perimeter.

Uniformity of skin surface temperature rise is maintained by monitoring the temperature at the periphery of the electrode array and/or by monitoring the impedance of each electrode in the array, either individually or in combination, so feedback can be provided to the control system with the aim of homogenizing and centering the treatment zone below the center of the applicator electrode array.

Impedance measurement and temperature feedback of subcutaneous tissue

One of the primary goals of hyperthermic treatments, including those applied to fat breakdown and tissue tightening, is to raise the temperature of the tissue beneath the superficial surface of the skin to about 39 ℃ to about 47 ℃, about 39 ℃ to about 44 ℃, about 41 ℃ to about 42 ℃, about 42-47 ℃, while maintaining the temperature of the skin surface at a normothermia of about 35 ℃ or less. However, the temperature at a certain depth is often unknown or invasive methods are required to monitor the sub-surface temperature, so that it has hitherto been difficult to infer the subcutaneous temperature directly from the surface temperature due to active cooling of the tissue surface. Therefore, the patient's sensation is typically used to determine the appropriate heating rate or dose.

However, the applicant has found that the measured impedance and subcutaneous temperature may be closely related. As discussed above, the impedance of the area under the electrode array can be mapped to determine where more or less energy should be deposited to compensate for anatomical changes. By observing the impedance map during the treatment, a strong correlation is observed 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 under a particular electrode, electrode cluster, or electrode array. It will also be appreciated that one advantage of knowing the temperature below the tissue surface is that treatment temperature variations can be minimized by compensating for variations in perfusion or regional anatomical hot spots that may determine overall sensation.

The figures described below depict exemplary aspects of the identified correlation between impedance and subcutaneous tissue temperature. As shown in fig. 7A, during an exemplary RF treatment, the tissue temperature at 1.5cm depth was determined by an invasive temperature sensor (fluorophore-tipped fiber, which is not RF-affected like a conventional thermocouple). The power in watts is on the right vertical axis, the resulting temperature in degrees celsius is on the left vertical axis, and the processing time is on the horizontal axis. As shown, the figure illustrates an ascending phase as the tissue temperature rises in the first few minutes of treatment, after which the RF power is reduced to maintain an approximate plateau of about 45 ℃. That is, the target tissue may be raised to a treatment temperature range (e.g., 42-47 ℃) during an initial heating or build phase, where the RF power (or duty cycle) is increased, after which the RF power (or duty cycle thereof) may be decreased to maintain the target tissue within the desired treatment temperature range (e.g., at a plateau of about 45 ℃ thereof).

The same exposure is plotted in another way in fig. 7B. Instead of temperature, fig. 7B depicts the total impedance of the combined electrode array plotted against exposure time for two different cooling temperatures, 15 ℃ as shown by the squares and 28 ℃ as shown by the diamonds. Based on this figure and in accordance with the present teachings, one skilled in the art will understand the explicit relationship between ramp and maintenance phase, where impedance is inversely proportional to the tissue temperature depicted in fig. 7A. One skilled in the art will therefore appreciate in light of the present teachings that this observation can be used to determine absolute or relative calibrations based on impedance measurements (e.g., relative to a starting point and recorded increments), which helps to maintain consistency and effectiveness of the RF processing.

The graph of fig. 7B also indicates that the detected impedance generally reflects a shift between different cooling settings (e.g., lower temperature is associated with higher impedance). In this case, the 15 ℃ cooling water (as shown by the squares) provides more conductive cooling of the patient surface and adjacent deeper tissue layers than the 28 ℃ cooling water (as shown by the diamonds), thereby causing a different offset or a different nominal starting impedance. Without being bound by any particular theory, this phenomenon may be due to the cooler tissue contracting the blood vessels, thereby causing a higher impedance to the cooler 15 ℃ surface temperature. It can be seen that for tissue in the 15 c water-cooled region, the initial impedance (resistance) of the electrode is higher than for tissue in the less cooled region (28 c cooling water), where the impedance difference is about 19-20 ohms. As described above, patient impedance is inversely proportional to the temperature increase at a given depth, such that when comparing FIGS. 7A-B, one of skill in the art would understand, in light of the present teachings, that a temperature increase of about 11-12℃ at a depth of 1.5cm corresponds to a decrease in patient tissue resistance of about 19-20 ohms. Furthermore, in the 28 ℃ and 15 ℃ curves, similar increases or decreases in patient tissue resistance (impedance) were observed, indicating similar temperatures at depth. In view of this relationship, the incremental impedance that occurs during treatment can be effectively used according to various aspects of the present teachings, for example, to determine the treatment endpoint and to help maintain a consistent treatment temperature at a depth, thereby reducing the side effects of over-treatment and improving efficacy. Thus, according to various aspects of the present teachings, a control scheme may be provided in which changes in patient tissue impedance may be monitored during treatment, and in which the energy emitted to the patient is reduced or increased to keep, for example, the target value of the resistance down (e.g., about 19-20 ohms). That is, the RF signal may be adjusted or regulated by a closed loop algorithm to bring the impedance close to a target value and then maintain the impedance at the target value.

Multiple treatment pads

According to various aspects of the present teachings, a plurality of treatment pads may be used. In the simplest form of the pad, one array may be used as a "source" and the other as a "return". The two electrode arrays may cover the same region and the clinical endpoints of the two regions may be the same. In this case, there is no return electrode where the current uselessly completes the circuit, but the return current performs exactly the same tissue heating as the source current. This approach may also support multiple electrode arrays, such as two or more electrode arrays or three or more electrode arrays.

Running multiple treatment pads

In some aspects, as discussed herein in connection with fig. 1A and 1E, two or more treatment pads (e.g., treatment applicators having an electrode array)) can operate in a bipolar or hybrid configuration. In embodiments where there may be two or more treatment applicators, each may have an active electrode array that is endowed with its own DC and RF drive circuitry, which may be independently controllable, including voltage and phase.

The two or more treatment applicators each have an RF drive circuit that operates 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 a subject or patient) are connected together and referenced to a single drain electrode.

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

In another embodiment, two or more arrays of active electrodes are used and a minimal 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 minimal amount of current flowing through the drain electrode. The method may be used with any number of active electrode arrays greater than one, including an odd or even number of active electrode arrays. For example, it is feasible to use phasing such that three active electrode arrays share all the current between the three active electrode arrays, with the current flowing through the drain electrode being minimal.

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

Active electrode phasing can also be adjusted to compensate for anatomical placement of various 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 act as one large array of electrodes, effectively heating the desired tissue. Phase control of the signals transmitted to the electrodes may be used to effectively control energy, current, RF signals, power delivery, and other parameters within or near a given target treatment area to facilitate a target tissue treatment or other target for a given treatment.

It should be appreciated that this exemplary architecture may thus provide for the use of any number of active electrode arrays to achieve large area tissue heating without limitation by return electrode size, and also have greater flexibility with respect to the placement of the active electrodes.

In one exemplary configuration, three treatment applicators may be connected in a Y-shaped or star-shaped configuration, wherein each applicator is provided with RF outputs 120 degrees out of phase with each other, and wherein the sum of the RF currents on the neutral pad (e.g., drain electrode or return electrode) is substantially zero, thereby causing a minimum amount of current to flow through the drain electrode. Other exemplary configurations will 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 may, for example, 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.

By providing an equal number of electrodes having a phase angle of 0 and a phase angle of 180 degrees, any even number of applicators can be applied, as a result of which substantially zero neutral or minimal amount of return current flows through the return pad. In the case of an odd number of applicators, a multiple of three may be used, with the result that by delivering 120 phase angles, the neutral return current is substantially zero or the amount of return current is minimal, and wherein the number of applicators operating at each phase angle is equal with respect to each node. For example, in the case of six applicators, two applicators may be applied with an RF signal having a phase angle of 0, the other two applicators may be applied with different RF signals having a phase angle of 120 degrees, and the remaining two applicators may be applied with different RF signals having a phase angle of 240 degrees.

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

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

The effect of these methods, where the neutral return currents sum to zero (except for one treatment applicator), is that any number of treatment applicators can be used without fear of overheating the return pad. As a result, a large area of the body can be treated/covered with the treatment applicator at the same time, while only a single return pad need be used. Optionally, multiple return pads may also be used. In this case, the size of the individual applicators will increase, since the return current (corresponding substantially to only one applicator as described above) will be distributed between the return pads. This may allow for scaling of treatment applicator size and number of treatment applicator/electrode arrays to properly address a given treatment area. In these examples, substantially zero assumes that the energy delivered to each treatment applicator is substantially equal (e.g., substantially uniform underlying anatomical structure). However, with small observed variations in the RF power delivered to each treatment applicator or electrode array, a minimal amount of return current can flow to the drain (return) electrode due to variations in the anatomy below each applicator or electrode array.

Referring now to fig. 7C, an exemplary electronics of a system 700 is depicted, wherein inset 700' represents a block diagram of a single electrode array/applicator, in accordance with various aspects of the present teachings. Element 720 represents the neutral return circuit.

Elements

730, 740, 750, 760 represent four separate RF amplifiers (e.g., RF energy sources) connected in a Y-configuration and operable at any phase angle relative to each other. Each RF amplifier is connected to a single electrode array/treatment applicator. For example, an RF amplifier 730 is connected to the electrode array 700'. As shown, an adjustable 48V isolation DC power supply 770 provides power to four RF power amplifiers. The block diagram of the system controller 780 determines the operating level and phase angle at which each RF amplifier operates. An isolated communication circuit 785 connects each applicator to the system controller 780. Applicator/electrode array controller 790 switches individual electrodes within a single array and also monitors individual electrode voltages, currents, and phases 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 further herein, the controller 790 is capable of adjusting 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.

In some exemplary aspects, a system for treating patient tissue may include two or more treatment applicators for treating a single area of patient tissue (e.g., the abdomen) or treating different areas of patient tissue (e.g., the upper arm and thigh). To enable both types of treatment, each treatment applicator may have its own individually controllable RF energy source, and each RF energy source may 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 may be controllable. In particular, the phase and amplitude of each of the two or more sources of RF energy may be controlled relative to each other to enable current sharing between two or more applicators. In various aspects, this ability to share current between two or more applicators may enable the applicators to be flexibly placed on the subject's body such that two or more applicators may be placed in the same treatment area (e.g., the abdomen) or in two different treatment areas (e.g., one applicator placed on the upper arm and another applicator placed on the thigh) such that each different treatment area may deliver an appropriate amount of RF energy thereto. For example, in embodiments where one applicator is placed on the upper arm, any excess current flowing to the upper arm that is not necessary to treat the target tissue may be shared (e.g., diverted) with another applicator to treat the thigh tissue, which is an area of higher tissue density than the arm. In some embodiments, a return electrode or a drain electrode may additionally be used. In various aspects, each of the two or more treatment applicators can have a plurality of treatment electrodes (e.g., an array of treatment electrodes) configured to be disposed 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 RF signals can be applied.

Drain pad

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

Water temperature change

The change in water temperature can be caused by changing the set point of the coolant and thus the heating profile of the skin. Cooler temperatures will cause the region to be heated deeper, and conversely, heating the water will cause the region to be closer to the dermis to tighten. In various aspects, as discussed further herein, the circulating water can be configured to maintain the skin temperature within a range of about 15-35 ℃ during treatment, adjusted to affect the sensation/patient comfort and/or control the depth of the heating zone.

RF regulation

Modulation of RF power can be used to improve sensation (e.g., reduce patient pain). For example, the warming process may be limited to the target tissue while maintaining the temperature of the tissue (e.g., epidermal and/or dermal tissue) at a depth above the target tissue below the damage threshold (i.e., below about 46-47 ℃). For example, RF treatment parameters (such as delivery mode, power, pulse duration, etc.) may be adjusted over the treatment time, and in some aspects by taking into account the cooling rate of the skin surface, an optimized temperature profile/gradient in the target tissue (e.g., tissue near or below the dermal/hypodermal junction, such as hypodermal tissue) may be achieved during treatment.

Electrode sampling

Sampling of each individual electrode for control purposes may preferably be performed at a frequency that avoids muscle neurasthenia. Although the fundamental frequency is between 0.5-4MHz (lower frequencies may be preferred to reduce cross talk between the electrodes), the control loop may operate at a frequency close to 100 Hz. The adjustment of the duty cycle of each electrode should be staggered to reduce the effects of neurasthenia.

Exemplary treatment of mucosal tissue

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

For example, Stress Urinary Incontinence (SUI) is a condition characterized by an inability to prevent involuntary urination when the body is subjected to stress, such as coughing, sneezing, or vigorous movement. It is usually the result of a weakening of the muscle strength around the neck and urethra of the bladder. SUI is commonly reported by postmenopausal women and is thought to be associated with vaginal changes that occur during menopause, which weaken the vaginal wall or muscles located between the vaginal wall and the urethra. While surgical intervention is well known and sometimes necessary in cases of severe vaginal relaxation, surgery is often undesirable due to high cost, long recovery periods, and potential side effects and complications. Accordingly, a non-surgical device and method for treating SUI and other genitourinary disorders, particularly in women, would satisfy a long felt need.

In various aspects, methods and systems according to the present teachings can treat SUI by applying RF energy to the vaginal wall to deliver a controlled amount of heat to remodel tissue (e.g., the anterior vaginal wall). The tissue may be the vaginal wall itself or tissue adjacent to the vagina in the vicinity of the urethra. For example, the target region of localized heating may be tissue between the vaginal wall and the middle urethra. In certain aspects, the target tissue can be heated to about 40 ℃ to about 45 ℃, or about 41 ℃ to about 43 ℃, or about 42 ℃ (e.g., without surface cooling). The RF energy may 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, the RF energy may be applied for about one minute to reach the desired temperature in the target tissue region and continued to maintain the desired temperature for about 5 minutes. The heat source can thereafter be deactivated, and the treatment probe can be allowed to cool and removed from the vagina. In some cases, the entire procedure may 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 greater than about 40 ℃ to about 45 ℃, such as about 40 ℃ to about 70 ℃, or about 45 ℃ to about 60 ℃.

In certain aspects, the method can include the step of applying RF energy to the anterior vaginal wall to a treatment depth of about 2 to 9cm, preferably about 5 to 8cm, or more specifically about 7cm beyond the outer vaginal wall surface. In such embodiments, the anterior portion comprises about 120 degrees of the vaginal wall closest to the urethra, e.g., about 10 to 2 o 'clock, 11 to 1 o' clock, 11 o 'clock to 12 o' clock, defined by the portion of the vaginal wall closest to the urethra.

In some aspects, it may be desirable to uniformly heat the entire target volume. As discussed further herein, various methods of ensuring uniform heating by varying the power delivered by each electrode. However, in some aspects, the methods of the present disclosure may further include delivering heat to a plurality of tissue sites within the target region using the electrode array. This staged heating creates a lattice of high heat islands, each surrounded by relatively unaffected tissue. This "staged" treatment may be an ideal method of tissue remodeling because the damage occurs in small sub-volumes or islets within a larger volume being treated. Because the resulting islets are surrounded by adjacent healthy tissue, which is substantially undamaged, the healing process can be complete and rapid.

Devices and methods are disclosed for treating female genitourinary disorders, such as urinary incontinence, and particularly stress urinary incontinence, to remodel tissue in muscles adjacent to the vaginal wall in the anterior region of the vaginal wall and/or adjacent to the urethra.

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

The probe may 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 may be a thermistor or an Infrared (IR) sensor configured to detect black body radiation emitted by the heated tissue. Alternatively, temperature monitoring may be achieved by one or more electrodes acting as impedance measuring electrodes. The present application describes the relationship of impedance as a function of temperature. The probe may also include a cooling pad to avoid overheating the vaginal wall surface, allowing heat to be delivered primarily to the target tissue region below the surface.

In some embodiments, the probe may include an array of pads or electrodes, programmable such that a subset of the array components may be activated to deliver heat to a particular region or in a particular pattern. For example, the RF electrodes may be distributed over all or part of the surface of the probe to heat the entire vaginal fornix or a portion of the vaginal wall. The plurality of electrodes allows not only monopolar processing (characterized by an energy path from at least one electrode to a remotely located return pad) but also bipolar processing (wherein energy flows between the electrodes). In some embodiments, multiple electrodes may also be used to monitor tissue impedance (or simply resistance) in order to map potential tissue and/or to further control the procedure. For example, adjusting the power of individual electrodes based on the tissue impedance map may be used to homogenize the temperature rise of all treatment regions. Controlling the output power of the various electrodes (e.g., via the gate duty cycle) also allows the clinician to achieve a controlled and consistent tissue temperature rise across the range of treated tissues. This is particularly useful for devices that are secured to the anatomy, activated, and then monitored only by a physician or staff.

In certain embodiments, the probe may further comprise one or more fixation 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 fix the probe in a desired orientation in place and at a depth for treatment. The probe may also include one or more expandable elements that can be expanded upon insertion of the probe to force the energy delivery elements of the probe into proper contact with the anterior vaginal wall. The devices disclosed herein may be hand-held or computer-guided. The probe may include markings to indicate penetration depth.

The present teachings also include systems incorporating 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 an imaging element, 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 region. Alternatively, the probe may be used in conjunction with a separate imaging system, such as an ultrasound, X-ray or fluoroscopy imager.

In other aspects, the devices and methods disclosed herein can be used to treat other genitourinary disorders by delivering a controlled pattern of heating or RF energy to other areas of the vagina. One or more embodiments of the present disclosure may further be used to generally restore vaginal tissue and provide relief from a variety of climacteric urogenital syndromes (GSM).

It is believed that the proximity of the urethra and vagina affects the improvement of SUI symptoms. Without being bound by any particular theory, it is further believed that heating of the vaginal wall and adjacent tissue between the vagina and urethra causes tissue remodeling by contraction of the target tissue, collagen regeneration, weakening, or a combination thereof, such that the symptoms of urinary leakage are ameliorated.

Referring now to FIG. 8, an exemplary system 800 in accordance with various aspects of the present teachings is schematically depicted. As shown, the system 800 includes a console 810 that houses the 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 of the features described herein with respect to node 1. In various embodiments, node 1 may be disposed in or near the console 810. The display 832 may be, for example, a touch sensitive screen that provides a Graphical User Interface (GUI) and/or the console 810 may provide separate user controls 811. As noted above, while some exemplary applicators are described herein as generally planar (rigid or flexible) electrode arrays, in some exemplary aspects, the applicators may be configured to be inserted into a patient (e.g., through a lumen or natural body orifice) in order to apply RF energy to a mucosal tissue surface (e.g., vaginal wall, esophageal lining wall). For example, as shown in fig. 8, the applicator may include a generally tubular probe 830 (e.g., a rod applicator) that may be sized and shaped to be inserted into the vagina or esophagus to RF treat it. The console 810 may be connected to the intelligent temperature-controlled probe 830 via a cable or umbilical 833, for example, for delivering RF energy to the probe 830 from a generator disposed within the console 810. In certain aspects, the console 810 can also house a coolant source to provide circulating coolant to the applicator probe 830 via a cable or umbilical 833, as discussed further herein. It should be understood that in certain aspects, the probe 830 may instead be wireless and contain its own RF generator, electronics, cooling, and power source (e.g., rechargeable battery).

As shown in FIG. 8, by way of non-limiting example, the 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 about 1cm²The individual area of (a). One skilled in the art will appreciate from the discussion herein that probe 830 may include a plurality of electrodes (or a set of electrodes or an array of electrodes) that may be activated to apply RF energy to target tissue in a monopolar or bipolar mode. For example, in some aspects, one electrode or set of electrodes of probe 830 may represent an "active" electrode, while another electrode or set of electrodes may represent a neutral "return" electrode. Alternatively, it should be understood that a return pad may be placed on the skin surface (e.g., near the pubic region, on a portion of the patient's leg) during vaginal treatments to provide a path for RF energy provided by the electrodes to return to the vaginal mucosal lining. Additionally, as discussed in detail below with respect to fig. 11 of the individual probe 1130, the electrode array 1160a may be comprised of a tip electrode 1162a configured to partially ablate the mucosa (e.g., 50 individual electrodes in a 5x 5mm area). Referring again to FIG. 8, the probe 830 may also include one or more temperatures A degree sensor 842. In various aspects, the probe 830 can also include markings 844 to indicate its depth of penetration into the vagina.

As shown in fig. 9, the system 800 may also include a locking sleeve or sheath 850 (or introducer) that may be used to guide the procedure, e.g., to ease insertion, provide alignment and/or set depth based on bladder neck probing with a Foley catheter or manual probing of the vagina. For example, probe 830 may include grooves 851a to mate with corresponding ridges 851b on introducer 850, but other mating or locking mechanisms may be substituted as will be appreciated by those skilled in the art in light of the teachings herein.

Referring now to fig. 10A-C, an exemplary method of processing a SUI in accordance with various aspects of the present teachings is illustrated. In particular, fig. 10A provides a schematic representation of a female urogenital tract including a uterus 802, vagina 804, bladder 806, and urethra 808. At the vaginal ostium, the urethra 808 and the vaginal wall are anatomically approximated. However, as the urethra 808 approaches the bladder neck, the urethra 808 separates from the vaginal wall. In various exemplary aspects, this is for a region of RF-based hyperthermia treatment (e.g., near the mid-urethra).

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

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

As described above, in certain aspects, when the urethra 808 is separated (e.g., offset) from the vaginal wall, the target region for RF-based hyperthermia treatment (e.g., near the mid-urethra) can be located at about the mid-urethra. In various exemplary aspects, the target region 809 can be tissue outside the vaginal wall between the vagina 804 and the urethra 808. To heat the area via the application of RF energy, the electrodes 862 of the probe should preferably be placed in contact with the anterior wall of the vaginal fornix, as shown in FIG. 10B.

Referring now to fig. 10C, an exemplary procedure is depicted in which a probe 830 is placed in contact with a desired area of the vaginal wall such that one or more electrodes 862 can heat the vaginal wall via application of RF thereto, in accordance with various aspects of the present teachings. It will be appreciated that if it is desired to heat a greater length or width of vaginal tissue (or to automate the procedure) with easier hand movements, for example, more than one electrode 862 may be used simultaneously to apply RF energy. In various exemplary aspects, the probe 830 can further include an inflatable balloon 832 to stabilize the probe 830 in contact with the vaginal wall surface. As discussed further herein, for example, electrodes 862 may be connected to a common node (e.g., one or more electrode clusters) or may 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 set of electrodes 862) can be activated to apply RF energy to target tissue in a monopolar or bipolar mode. Alternatively, it should be understood that a return pad (e.g., pad 130e of fig. 1C) may be placed on the skin surface (e.g., near the pubic region, or on the patient's thigh) during vaginal treatment to provide a return path for RF energy provided by electrode 862 to the mucosal lining wall of vagina 804. Alternatively, in various aspects, the catheter 801 can serve as a return path to concentrate energy in the tissue between the vagina 804 and the urethra 808. It will be appreciated that this configuration can help focus tissue heating to the vaginal wall immediately adjacent to the urethra 808, any muscle therebetween, and the urethra 808 itself. In yet another aspect, the probe electrodes 862 can be bipolar, such that one electrode 862 in the array 862 (or set of electrodes) serves as a processing "active" electrode that transmits RF energy, while one or more other electrodes in the array 862 serve as "return" (grounded) electrodes to provide an electrical return path for the RF energy. In some aspects, pulsed RF, which concentrates high energy in short pulses, may be preferred.

In some aspects, a two-handed set-up 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 832 or other means, and employ feedback to determine probe 830 (and its electrodes 862) contact to initiate RF application. According to various aspects of the present teachings, the probe 830 can then be operated in order to uniformly deposit RF energy, maintain a uniform desired temperature range in the target region, provide consistent dosimetry, and/or provide surface cooling, as discussed further herein.

For example, the probe 830 may also include a cooling mechanism 835, such as one or more cooling surfaces interspersed with electrodes 862 that cool the vaginal wall surface by circulation of a coolant through the probe 830. Alternatively, in various aspects, cooling may be achieved by a thermoelectric (Peltier) device or using a phase change material (e.g., ice) in thermal contact with the patient contact surface (e.g., via electrodes). As discussed further 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 such that heating the target tissue is not limited by patient tolerance (e.g., in the range of about 40 ℃ to about 45 ℃). For example, the target temperature may be increased by cooling to a temperature in the range of about 40 ℃ to about 70 ℃, or about 45 ℃ to about 60 ℃.

Referring now to FIG. 11, another exemplary probe 1130 in accordance with aspects of the present teachings is depicted. As shown, the probe 1130 can include a plurality of different electrodes 1162 disposed on the entire surface of the probe 1130, opposite the front, distal region of the probe. It will be appreciated in light of the present teachings that advantages of such a probe 1162 include the ability to treat the entire vagina 804 by turning on and off different electrodes. This type of probe (electrodes over the entire surface) can treat vaginal conditions (recovery) other than SUI throughout the vagina. However, to address the SUI treatment target tissue region alone, the electrodes 1162 within the desired anterior vaginal region (e.g., at the 10-2 o' clock position) may be energized while the other electrodes remain off. In addition, such a probe may allow the clinician to adjust the position over a range of greater than 10 o 'clock to 2 o' clock, for example, by energizing more electrodes, thereby treating a larger area of tissue, up to and including the entire circumference of the vagina. Such a probe may also allow the clinician to adjust the range of positions to be narrower than 10 o 'clock to 2 o' clock, for example, by energizing fewer electrodes, thereby treating a smaller tissue region. Any desired area (or the entire vagina) can therefore be selected for treatment.

Various aspects of RF process control may be based on feedback from multiple temperature sensors along the urethra. If the urethra is the heating target for stimulating tissue and surrounding musculature, installing a monitor within the urethra helps to standardize clinical results and significantly improve safety. Thus, monitoring the temperature at discrete locations along the conduit may facilitate detection of any thermal anomalies, such as hot spots. Additionally or alternatively, these discrete temperature sensors may inform the process endpoint decision. Thus, changes in patient anatomy and tissue perfusion can be compensated for by monitoring actual tissue temperature rise during the application of RF energy.

In various aspects, the long duration low irradiance (about 1-5W/cm) discussed previously herein²) And short duration high throughput (about 10-1000J/cm)²) The approach may also be used for internally accessed tissue and may provide contrast advantages with respect to biological target selection and processing. Without being bound by any particular theory, the method of action may be thermal in nature, with the delivered RF power being used to heat or even coagulate the selected tissue. For a long continuous exposure, a uniform heating of the structure can be achieved. For a short, concentrated energy burst, a focal point of ablated tissue may be created. In various aspects, it may also be desirable to ensure uniformity of the delivered RF energy. To provide in some applications Effective treatment may require not only raising the temperature of the target tissue to a temperature range, but also maintaining 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 may confer a desired clinical benefit. As discussed herein, it may also be advantageous to actively control the RF energy to distribute energy through the target tissue in a homogeneous manner, uniformly, predictably, and automatically (e.g., without user intervention). In addition, the RF pulse duration may be used to select and/or target specific tissues. High amplitude short duration RF pulses, when focused on a small electrode-tissue interface region, can produce sufficient flux or current density to coagulate and vaporize tissue, resulting in the "staged" treatment described above.

Referring now to FIG. 12, another exemplary system 1200 in accordance with the present teachings is depicted. As shown, the system 1200 may 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 may be separate or housed together in a single console 1210). The system 1200 also includes at least one probe 1230a having an associated array 1260a of electrodes 1262 a. Individual electrodes 1262a of array 1260a may be independently switched by switching control 1211 to gate RF energy to individual electrodes in the array. The electrodes that are not actively receiving RF energy may be monitored by measurement circuitry 1213 such that each electrode serves as a signal path providing current, voltage, and/or phase angle feedback for use in calculating power and impedance at each individual electrode 1262 a. The system 1200 may also include an optional second probe 1230b to provide an electrical return path. The probe 1230b can 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 can be incorporated into a catheter for placement in the urethra of a patient. Alternatively or additionally, the system 1200 may also include a return (ground or neutral) pad 1230e, for example, 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.

As herein describedAs discussed further, the electrode array adapted for use on an internal tissue surface may also have a variety of configurations in accordance with the present teachings. For example, the electrode array may be configured as a probe including a metal coolant housing having an electrically insulative and thermally conductive layer between the coolant circuit and the electrode array (e.g.,

polyimides or ceramics, e.g. AlO₂Etc.). The electrode array may be attached to the applicator cooling housing via an adhesive such that a circulating coolant (e.g., cooling water from a coolant source) may cool the electrode array and an internal tissue surface (e.g., vaginal wall) of the patient with which the electrodes are disposed.

In various exemplary aspects, for example, an electrode array applicator may have 50 independently controlled electrodes arranged in a square, circular, or hexagonal pattern. Additionally or alternatively, the surface temperature of the patient tissue surface (e.g., vaginal wall) in the region around the perimeter of the applicator electrode array may be monitored by IR sensors, thermocouples, or the like (by way of non-limiting example) in order to identify uneven heating of the vaginal wall surface region adjacent the intended treatment zone. Based on these signals, the microprocessor and algorithm can provide correction factors for the RF power set points of the various electrodes to optimize process uniformity, homogeneity, and placement of the process zone. In various aspects, as discussed further herein, the impedance of the electrodes can be individually monitored, which can be used by microprocessors and algorithms to define an impedance profile of the patient and provide correction factors for varying the RF power set point to optimize process uniformity, homogeneity, and placement of the treatment region.

Cooling the internal tissue surface of the patient to which the electrode is applied (e.g., mucosal lining, vaginal wall) can protect the tissue surface, and can also improve patient comfort during surgery or minimize post-operative discomfort. Sufficient surface cooling (e.g., via circulating water within the probe at about 10 ℃ to 35 ℃) allows for the safe, comfortable application of greater amplitudes of RF power. This may be desirable because most target tissues are located at a depth from the internal tissue surface (e.g., vaginal wall surface), and thus surface cooling serves to protect the untargeted intervening tissue layer and allows heat to penetrate deep into the tissue. Because mucosal tissue tends to have nerve endings near the surface, cooling the tissue surface enables the subject to withstand higher temperatures at the desired treatment depth below the cooled surface.

As discussed above, an array of individually switched electrodes (e.g., individually controllable electrodes that can individually adjust/control RF power delivery) can be provided to help ensure or control that the treatment region remains centered at the desired treatment region (below the electrode array applicator), as well as to maintain a homogeneous and consistent temperature rise within the desired treatment region, regardless of potential tissue electrical impedance or anatomical changes of the patient. Each electrode (or subset of electrodes) within the array may be individually addressed and activated. For example, an impedance map may be generated for the entire vaginal vault, and activation of only certain electrodes is controlled to avoid untargeted structures based on this impedance information. The vaginal wall (and/or urethra) surface temperature can also be monitored and used for RF uniformity compensation. The application of uniform RF energy (e.g., at a frequency of about 1 MHz) through the vaginal wall and then into deeper tissues is complicated by different tissue types and different impedance changes. For example, fibrous structures and connective tissue have a lower impedance to RF energy relative to fat. Thus, the RF energy will preferentially propagate along the connective fibrous tissue as opposed to the fat. The heated connective tissue thereafter diffuses and/or conducts heat from the fibers into the adjacent fat cells and raises their temperature. Also, the impedance of muscle tissue is much lower than other tissue types. Because predictable RF uniformity is important for the effectiveness and safety of the applied RF treatment, non-homogeneous tissue structures in the target area should be considered. Because some tissue structures have higher impedance relative to other tissue structures (e.g., deeper muscle tissue), RF energy delivered uniformly at the surface can "drift" toward the direction of least impedance. RF energy will typically propagate to deeper tissue through the shortest path length of the high impedance layer closest to the vaginal wall. Thus, as discussed further herein, only one electrode (or a subset of the electrode array) may 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 may be individually adjusted to help provide uniform heating.

As discussed above in accordance with various aspects of the present teachings, selective tissue treatment and/or various treatments may be provided with the application of different RF pulse durations. For internal tissues, for example, low power RF energy (e.g., about 1 to about 5W/cm) of long duration (e.g., greater than 1 second, CW) can be expected²) And short duration (e.g., less than 500ms, less than 100ms) high energy RF pulses (e.g., about 10 to about 1000J/cm per pulse²、10J/cm²-500 J/cm²、10J/cm²-300 J/cm²、10J/cm²-100 J/cm²) And (4) scheme. In some aspects, high amplitude, short duration pulses of RF energy may be utilized to generate sufficient flux or current density to ablate, coagulate and/or vaporize tissue. For example, the RF pulse may be focused (e.g., focused) on a small area of the electrode-tissue interface in order to induce sufficient flux or current density to coagulate and vaporize tissue.

Referring to fig. 13, results of an exemplary RF-based treatment of bovine liver are depicted, wherein an electrode array is spaced apart and configured to deliver heat to a plurality of tissue sites within a target region such that treated portions are separated by untreated portions. In particular, the exemplary electrode arrays each include 20 electrodes to which RF signals are applied when the electrodes are in contact with the liver surface. The RF signal comprises 25ms pulses, with a pulse energy of about 30mJ for each electrode in the array of 20 electrodes. As shown in fig. 13, this exemplary process may be used to provide lesions (e.g., ablation, coagulation) to separate islets within a larger volume. In this "staged" treatment, the damaged islets (vaporized tissue) are surrounded by healthy tissue that is not substantially damaged by the application of RF energy. In various aspects, adjacent undamaged (e.g., healthy) tissue can improve the healing process of the islets of damaged tissue.

The results of another exemplary "staged" processing are depicted in fig. 14A-C. The RF signals applied to the two electrode arrays (each array having 20 electrodes for each of these figures) exhibit the same pulse energy of about 30mJ for each electrode in each array, but the duration of the RF signals is different. For example, fig. 14A shows a plurality of separate islands of vaporized tissue on the surface of a patient's skin resulting from the application of 35 milliseconds of RF pulse duration and energy to each electrode in the array. Fig. 14B depicts a separated island resulting from the use of a pulse duration of 25 milliseconds, while fig. 14C depicts a separated island resulting from the use of a pulse duration of 12 milliseconds. It is observed that for the same energy per pulse, a shorter pulse duration will cause more damage (e.g., tissue vaporization) at the focal spot.

As discussed herein, the present disclosure is directed to various embodiments. These embodiments include various applicator and electrode array designs that sandwich or combine or connect various components, such as reusable and disposable components. The flexible electrode array printed circuit board based design may include any suitable rectangular, arcuate, circular, regular and/or irregular shape, and combinations thereof. These flexible electrode arrays may be paired with foams, gels, and other materials to aid in patient fit. They can also be paired with rigid components containing electronic components designed for repeated use. This approach helps to solve the technical problem of creating RF-based treatment devices that can be used efficiently and in a timely manner to improve patient comfort.

Uniform heating systems and methods and additional applicator embodiments

In part, the present disclosure describes flexible non-invasive body contour applicators suitable for directing RF-based energy. The flexible applicator may 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 comprises a plurality of separate treatment zones, wherein each zone can be set 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 into a preferred treatment temperature range. The applicator uses an RF energy source/generator to generate heat via each treatment zone using RF heating through conductive traces and/or dielectric gradients. 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 the disposable applicator and operates as a quick disconnect/connect device. Individual zones/regions of the applicator may be activated to achieve uniform heating of each such zone/region. In addition, the zones/regions of the applicator are selectively activated to facilitate uniform heating of the entire area of tissue in contact with the applicator.

A given flexible RF applicator may be energized using an RF source having an operating frequency. In various embodiments, the operating frequency may be in the range of about 0.5MHz to about 10MHz and as otherwise disclosed herein. In one embodiment, the RF frequency used with the flexible applicator is about 3MHz or about 4 MHz. In addition, the zones or regions of the applicator may be addressed according to various schemes and patterns, wherein the various delay periods and variations in the addressing pattern may be controlled by the operator, for example by the individual operating the device and/or by achieving a predetermined temperature target for each zone/region that is maintained within a temperature range for a predetermined time range. Various distribution systems may be used to connect and address a given applicator. Regions or zones of the applicator may be activated or addressed to conduct the input electrical signal to a given region or zone on a zone-by-zone or zone-by-zone basis using random, cyclic, alternating, zigzag, and other addressing/activation schemes. Heating one tissue region below each interrogation region of the applicator allows for uniform heating without an uncomfortable sensation. This may be accomplished by cycling between and energizing the different regions, with heat extending from one region to the other, to facilitate heating of the entire concentrated tissue portion or regions located or extending beyond the applicator.

In various embodiments, all areas of the applicator are typically not activated simultaneously, although this may be possible in some cases. Typically, the applicator area is selectively activated according to one of the aforementioned protocols or patterns to promote uniform heating of the body area beneath the zone/area of the heated applicator. Further, the applicator includes a plurality of layers arranged in a stack or a combination of sub-stacks. Further, the applicator has a shape that is defined in part by an outer boundary or boundaries. The overall shape of the applicator is typically curved, with sharp edges and straight lines avoided as part of the applicator boundary. Elliptical, circular, arcuate profiles and curved boundaries, as well as combinations and fractions of the foregoing, are preferred to mitigate edge effects and uneven heating.

Various flexible and/or conformable applicators may also be used to implement RF-based treatments and treatment methods, including the cosmetic treatments disclosed herein. Fig. 15A illustrates an RF-based flexible applicator 880 suitable for directing RF energy to one or more tissues and body regions/volumes. As shown, the applicator 880 has six regions or zones R1, R2, R3, R4, R5, and R6 divided by seven cuts K. The incision K helps the applicator 880 to conform to the contours of patient tissue, such as the general skin, abdomen, and other patient tissue, but is not limited to such. In one embodiment, the cut is a gap between areas that are implemented to allow the flat applicator to conform to the compound curved surface. In various embodiments, the shape of the cut multiple layers defines the shape of the cut and the circular or elliptical strain relief element at the end of the cut. These strain relief elements/terminal strain relief elements may be incorporated into the various applicator designs disclosed herein.

In general, in some embodiments, an applicator may include two or more regions having one or more cuts K. In some embodiments, the applicator 880 may have one area and not include a cut. The applicator is flexible and is 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. The applicator 880 includes an electrical connector 890 that includes a plurality of electrical contacts 892. The contacts may be connected to electrical traces disposed in or on the applicator.

In one embodiment, the electrical connector 890 is part of the applicator 980. The electrical contacts 892 connect to electrical traces and other electrical components of the applicator. The applicator 880 may also include a strain relief device/element 885 disposed relative to the flexible layer, for example by surrounding or sandwiching the applicator and the electrical connector 890. The electrical connector 890 may include one or more alignment devices 895 adapted to facilitate alignment of the electrical contacts 892 with corresponding electrical contacts of an interface device. The first surface 900 of the applicator may include one or more labels. In one embodiment, the integer N or other variable may be used to refer to N conductive traces, such as copper traces that direct RF to N outer 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.

Uniformity-flexibility/profile

In various embodiments, the applicator has a cut K. The cuts are voids or cuts in the flexible layer stack that function in a manner similar to the spines in a garment so that the applicator sheet can accept the contours of the body while remaining in contact. The use of slits may improve the tolerance of the thickness of the sheet. When the applicator size is greater than about 50cm²The incision is used to provide flexibility of the applicator when treating the area. The incisions K enable the applicator to accommodate a larger treatment area and for multiple zones/regions R1-RN in a single applicator.

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 the stomach, abdomen, submental region, organs, organ systems, skin, subcutaneous tissue, body tissue, any of the regions of the face, arms, legs, and other regions, lumens, or volumes of the patient). Selective and alternating excitation of the regions of a given applicator is performed to promote uniform heating of the target tissue, separating the regions of a given RF-based applicator along one or more boundaries, such as incisions or channels.

A given applicator includes a stack of layers and has a first side 900 as shown in fig. 15A. The second or tissue-facing side is the surface opposite the first side. Additional details regarding the layer stack are described with respect to fig. 18 and 19A and elsewhere herein. In general, each applicator has a first side and a second side. In one embodiment, first side 900 corresponds to a label side, also referred to as a vinyl or polymer side or upper or top side. Alternatively, the second side refers to the gel side, the wet side, the underside, or the patient-facing side. 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. Reference to the first side and the second side is not limiting and may refer to any of the aforementioned sides of the applicator as dictated by the context.

Shape/extensibility

In various embodiments, the applicator may have a different shape. Preferably, the applicator has a curved boundary compared to a straight boundary, such as a polygonal boundary. Oval, circular, elliptical, curved, and other shapes may be used to designate the shape of the applicator and/or its outer edges or boundaries. For example, in various embodiments, the applicator is shaped as an oval or football with a surface area of a particular patient size or tissue of interest (i.e., about 225 cm) ²Or about 300cm²) And (4) customizing. 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 may be scaled according to the potential area on the body to be treated. Further, in various embodiments, the applicator may 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 cuts. GeometryThe shape and size limitations may be configured based on the energy available from one or more of the systems described and depicted herein (such as

systems

100, 800, 1200).

In various embodiments, the applicator may selectively control and/or open/close one or more zones. In some embodiments, regions may be selectively sized to effectively process regions smaller than neighboring regions. Further, in some embodiments, the applicator may 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, scar, etc.). This may be controlled by a user interface on a display connected to the system 100. An exemplary portion of an applicator that can be used to compensate for the presence of a navel, scar, or other depression is shown in fig. 15C as region 912. As shown in fig. 15C, region 912 is part of region R5. In some embodiments, the entire area, such as the area/zone R5 of the applicator 905, may be selectively avoided so that RF energy is not transmitted to the navel or other sensitive areas. In other embodiments, region 912 may be enlarged, reduced, and/or moved to other regions depending on the location of the sensitive region. The deactivation of the area of the user interface suitable for use with the treatment systems and applicators disclosed herein is shown in fig. 28A and 28B.

In various embodiments, unwanted edge effects are avoided by selecting a dielectric/trace for a given zone, in some embodiments, one temperature sensor, such as a thermistor, is used per zone/area to regulate the target tissue temperature, such as skin temperature. In some embodiments, two thermistors are provided per zone for redundancy and to provide redundancy in the event of a failure of one. For example, in region/zone R5 of applicator 900 in fig. 15A, two temperature sensors H are shown. Each temperature sensor H is connected to one or more electrical conductors which, in turn, are in electrical communication with one or more electrical contacts in 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 identifies an internal depth temperature from the external temperature reading. In one embodiment, one or more applicator temperature sensors (such as thermistors) are used to measure the outer surface of the tissue or applicator surface temperature. The internal temperature at depth is then discerned from the reading. This is because the internal temperature is related to the surface temperature of the tissue/applicator that contacts the tissue.

The target skin surface temperature range is from about 40 ℃ to about 44 ℃. This is related to temperatures at depths ranging from about 41-45 deg.c. In some embodiments, the temperature range may be extended to about 42 to about 47 ℃ due to heat accumulation.

In at least one embodiment, the applicator provides uniform heating up to a target surface temperature range (about 40 to about 44 ℃) when applied to skin tissue, which corresponds to a range at a depth of adipose tissue (about 42 to about 47 ℃). 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 adipose tissue below the target surface). One or more heat/temperature sensors are integrated in each zone or section of a given applicator. In various embodiments, two heat/temperature sensors (such as, for example, thermistors) are disposed in each applicator zone.

In various embodiments, the applicator is capable of individually setting the temperature of each individual treatment zone. In some embodiments, one or more of the individual zones may have different target temperatures or may be completely shut down according to a prescribed treatment process. For example, a treatment area placed above the navel area may be closed due to sensitivity. In various embodiments, the amount of zone heating may be determined by the ratio of the change in resistance to the resistance (Δ R/R), which is the change in resistance. During the 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 exemplary range of processing times is from about 12 minutes to about 15 minutes. In one embodiment, the time of activation of each zone is 12 to 15 minutes divided by the number of applicator zones.

In various embodiments, the applicator is adapted to apply energy to a uniform volume of tissue. Uniformity or overall uniformity is achieved by using zone-by-zone uniformity across each treatment zone of the applicator. In some embodiments, each zone/region is heated for a period of P or about P, where the total treatment time TTT is the product of (about P or P) (the number of applicator regions). In one embodiment, about P or P ranges from about 20 seconds to about 2 minutes. In one embodiment, about P or P ranges from about 40 seconds to about 3 minutes. In one embodiment, about P or P ranges from about 1 minute to about 2 minutes. In one embodiment, about P or P ranges from about 1.5 minutes to about 2.5 minutes. In one embodiment, about P or P ranges from about 1 minute to about 10 minutes. In one embodiment, about P or P ranges from about 1 minute to about 3 minutes. In one embodiment, about P or P ranges from about 2 minutes to about 8 minutes.

Outside the boundaries of the applicator, the energy applied by the applicator may cause thermal diffusion. For example, in at least one embodiment, the tissue under the incision eventually reaches a uniform temperature or within a particular treatment temperature range due to heat delivered by the two or more regions of the applicator and transferred across the tissue under the incision. In one embodiment, the cut terminates within the boundaries of the applicator at a channel, hole, or other opening, such as opening 910 shown in fig. 15C. In some embodiments, the holes or openings are circular or oval. These holes or openings may serve as stress relief elements.

As shown in FIG. 15A, applicator 900 includes zones or regions 1-6, R1-R6. In some embodiments, the applicator comprises an outer label exhibiting and listing 1-6, R1-R6. Such a labeled outer layer is shown in applicator 905 in fig. 15C, where areas 1-6 show numbers printed on the applicator label, each number within a circular boundary. In one embodiment, the digital print on the label is white, but may be any suitable color. In one embodiment, the label comprises vinyl, plastic, or another polymeric material. Marker zones 1-6 correspond to applicator zones or zones R1-R6. These regions may be displayed on a user interface to facilitate deactivation of one or more regions prior to starting a process.

In one embodiment, each zone or area is bounded by two cuts K, for a total of seven cuts K. In some embodiments, the applicator may use fewer zones, more zones, and/or have different shapes and sizes. The geometry and size of the applicator are limited depending on whether the RF generator can provide sufficient energy to heat the desired treatment area. At the initial stage of treatment, each treatment zone of the applicator sequentially activated R1 to R2, R2 to R3, R3 to R6, R6 to R5, and R5 to R4 in a clockwise fashion. A counter-clockwise activation scheme as described herein or other activation schemes and modes may be used. Thereafter, the temperature of each zone was measured using the temperature sensor H and modified as necessary to maintain the set surface temperature (40-44℃.). Each treatment zone was individually maintained at a temperature in the range (42-47 c) to achieve a set surface temperature (40-44 c) for the entire area covered by the applicator. In this embodiment, the applicator coverage area is 300cm ². In various embodiments, the size range of the applicator may be about 50cm²To about 600cm². 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 grey or silver metallic visual element. In one embodiment, the applicator comprises a label comprising one or more pigments arranged to display a metallic, metal or metal-like appearance.

Flexibility

In various embodiments, the flexibility of the applicator is enhanced by cuts/voids that make the applicator sufficiently flexible to conform to the contours of the body. For example, as shown in fig. 15A, each incision releases a respective portion/zone of the applicator to bend depending on where the portion/zone is applied to the body. The applicator shown in fig. 15A 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 a plurality of non-incision regions, such as an interior region or spine, from which regions or regions extend and before which the various incisions terminate. An exemplary interior region 495 is shown within the dashed line in fig. 22A. The inner 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 more and more conductive traces are placed adjacent to each other in this area. As a result, the inner region may generate excessive heat. As a result, the interior region may include one or more heat shields. The inner region 495 has a telescopic, mortarless, stepped or tapered configuration that follows a decrease in the number of adjacent traces moving away from the applicator's electrical connector 890 in the direction of the dashed arrow AW.

The dielectric of the applicator has a dielectric constant in the range of about 3 to about 4, which provides a balance of capacitance and dielectric thickness, while also having the flexibility of the applicator suitable for contacting patient tissue. As another consideration, when selecting a dielectric material for an applicator, it is desirable that the material have a low heat loss or dissipation factor and also be able to withstand high temperatures to allow for welding of the assembly relative to the conductor with which the dielectric material is used. In addition, 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 may be replaced by any dielectric that meets these requirements.

Uniform heating-applicator considerations

In various embodiments, each zone of the applicator includes a plurality of 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 processing region.

Fig. 18 shows an exemplary arrangement of material 940 of an applicator or a portion thereof, e.g., a region of an applicator, according to an embodiment of the present disclosure. These layers are also combined to form the applicator 980 in fig. 19A. As shown, there is a first side 900 and a second side 945. In one embodiment, the first and second faces correspond to the vinyl and wet faces, and vice versa. Alternatively, in one embodiment, the first and second sides correspond to a patient facing side and an air facing side, or vice versa. During treatment, the wet side is in contact with the patient tissue to be treated. In some embodiments, an aqueous gel, such as a hydrogel, is applied to the tissue/wet facing side to reduce or avoid air gaps. Furthermore, the use of such gels may increase the amount of current that can penetrate tissue. In various embodiments, one or more thermistors are placed within each zone to monitor temperature during a given processing method. A temperature sensor is in communication with the control system and can be used to vary the current level when higher RF energy and associated current levels may cause edge effects or uneven heating conditions. In at least one embodiment, the six-zone applicator includes a thermistor in each zone.

As shown in fig. 18, an optional release liner 946 may be included in a sterile disposable applicator and peeled away prior to application of the applicator to a patient. In some embodiments, the pad protects the gel layer 960. The two layers of

dielectric material

950A, 950B sandwich the conductive layer 955 and the polyimide layer 957 with an adhesive, which may be provided as two

layers

953A, 953B. In various embodiments, the dielectric material layer may include a Kapton layer, such as a capping layer or a capping layer. The

layers

950A, 950B, 957 may be dielectric layers, such as first, second, and third dielectric layers. Conductive layer 955 includes a metal or electrical trace arrangement. In various embodiments, the conductive layer comprises copper or copper traces. The copper layer may comprise a continuous thin layer of copper metal. Alternatively, for the various embodiments, the copper layer includes a plurality of copper traces extending into each zone or zone of the applicator. The degree to which traces are placed close to each other and more traces are grouped in parallel or concentric or other configurations can result in increased trace density. Also shown is a patient contact layer 945, such as a water-based gel layer. The arrangement of the various layers of fig. 18 is also shown with respect to the exploded view of the applicator in fig. 19A.

In fig. 19A, the releasable liner 946 is adjacent to the gel layer 960 or below the gel layer 960. The thermal insulation layer 975 also serves to protect the interior region or spine of the applicator. In some embodiments, insulation layer 975 is elongated and optionally flared or tapered. The flexible applicator 880 includes the conductive layer, the plurality of dielectric layers, and the adhesive layer described above. As discussed herein, the label may be disposed on the applicator. In addition, another release liner 947 may also be used. The strain relief element 885 may also be used to reinforce an extended area of the applicator including the electrical connector 890. In one embodiment, the elongated region 893 extends from the applicator, such as terminating in a tail or parallel cable of the electrical connector 890. Fig. 19B and 19C show different views of the combination of layers shown in fig. 19A. In turn, fig. 20A-20F illustrate different views of an applicator 980 having one or more release liners. Fig. 21A-21F show various views of an applicator 981 that does not include a release liner.

As shown in fig. 22A and 22B, the copper traces may be arranged in various patterns such as various paths. In some embodiments, the copper traces are arranged in spirals, area-filling curves, nested straight-line areas, nested curved areas, and combinations thereof. An example of a conductive trace 490 is shown in fig. 22A and 22B. The center of a given zone includes a higher concentration of copper trace material, while the outer circumferential perimeter edge of the same zone exhibits a thinner copper gradient.

In various embodiments, the copper traces are arranged to have a greater density of locations or to be concentrated in the center of the area or in a particular portion of the applicator. In some embodiments, a higher concentration of copper trace material is present in the center portion of a given zone due to the placement of more copper traces relative to each other. Thus, in a portion of the applicator in a given area, more traces are 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 the thickness may vary within suitable ranges, such as from about 0.01 inches to about 0.3 inches. In some implementations, a group of traces having a common width or thickness may be densely packed in one area and less densely packed in another area. For example, in the ridge region, multiple traces are positioned parallel, side-by-side, adjacent, or otherwise adjacent to each other. This may result in additional heating of areas of increased traces located relative to each other and benefit from the inclusion of one or more thermal shields.

In various embodiments, Kapton may be replaced with another suitable dielectric, depending on the preferred dielectric properties described herein. Further, in these embodiments, the base polyimide may be replaced with another dielectric, i.e., polyester. In various embodiments, each layer of fig. 18 has a thickness ranging from about 0.5 mil to about 1.5 mil. In various embodiments, the optional hydrogel layer has a thickness greater than 1 mil.

The applicator is typically designed to be disposable and works with a suitable interface device 905 as shown in fig. 16. The interface device 905 is in electrical communication with an RF-based processing system, such as the

systems

100, 800, 1200 or other suitable systems disclosed herein. The interface device supports the use of sterile applicators and changes to applicators having different sizes, shapes, and areas, which facilitate alignment of the electrical traces. The interface 905 also supports quick connection and release of the applicator from the interface. The interface device shown is an exemplary device for connecting an applicator. In another embodiment, a pluggable cable interface releasably attached to the electrical terminal of the applicator and other interface means adapted for aligned contact with the plurality of electrical contacts at the electrical terminal of the applicator may be used.

As shown, the interface device 905 of fig. 16 depicts the clamp/clip device 920 and the 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 optical conduits or fiber optic portions. In various embodiments, a light pipe or fiber optic portion is used as part of the interface device to support an optical display upon actuation of the applicator or upon a particular state or treatment. The clamp/gripper assembly 920 may include one or more electro-optic conversion devices. The cable adapter 921 may 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.

Because of the edge effects present in the RF traces, the applicator uses selective dielectric insulation to create various dielectric insulation gradients across the applicator surface, and both manipulates the edge effects by tapering and/or scaling the trace geometry (fig. 22A, 22B) through the copper traces creating various gradients across the applicator surface for better temperature uniformity and flexibility.

Fig. 17 shows an alternative applicator embodiment 905 comprising nested dielectric regions. Within the applicator, in one embodiment, the conductive layer comprising copper is uniformly distributed throughout. As shown in fig. 17, 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 zone, there is one additional layer for each subsequent fade as one moves from the center outward. For example, there was one layer of dielectric DL1 in the center, two layers of dielectric DL2(1 mil thick) next outward gradient, three layers of dielectric (3 mil thick) DL3 next outward gradient, and finally four layers of dielectric DL4(4 mil thick) in the outer periphery. The central region 913 is an aperture defined by the layered assembly of the applicator and is adapted for placement over the navel or other sensitive area.

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 about 4 MHz. The 4MHz generator helps to provide RF energy uniformly over a large area on a dielectric using a thin common material. However, in other embodiments, other high frequency generators may be used. In one embodiment, a 3MHz generator is used. Suitable waveform generators for use with the flexible applicators disclosed herein are generally components of or in electrical communication with one or more

systems including systems

100, 800, and 1200 disclosed herein.

In various embodiments, the use of RF energy and the placement of current in the body for a given capacitive electrode area depends on various characteristics. For example, as the dielectric thickness decreases, the RF current increases in proportion to the tendency of any air to ionize. The relative permittivity (i.e., dielectric constant) of the dielectric layer increases, with the RF current and any tendency for air to ionize increasing in proportion. As the voltage applied to the electrodes increases, the RF current increases in proportion to the tendency of any air to ionize.

As the frequency of the RF waveform increases, the RF current increases proportionally. In contrast, any tendency for air to ionize 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 formation in the air near the tissue being treated by the applicator. Thus, mitigating corona or plasma discharge is one of the advantages of the RF-based applicators disclosed herein. In various embodiments, the frequency of the RF generator ranges from about 1 to about 5 MHz. In some embodiments, a 4MHz generator balances the requirements because inductance can be problematic at higher frequencies and the capacitance gradient required for uniform heating at lower frequencies is more difficult to achieve.

In various embodiments, the applicator exploits or manipulates edge effects by selective dielectric insulation placement and positioning, creating various dielectric insulation gradients, such as by thickness variation across the applicator surface, and grading and/or scaling trace geometries by creating various gradients of copper traces across the applicator surface. An example of such a trace 490 is shown in fig. 22A and 22B. The graded trace geometry creates multiple edges such that edge effects are present across the 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 in determining the topology of the applicator that mediates the electrical gradient and/or copper trace gradient.

In various embodiments, the patterns of material sandwiched together are as follows: dielectric, copper, dielectric, and the like. Stacks of various material layers may be used for a given applicator. In turn, various sandwich structures are possible, wherein one or more layers are sandwiched between two layers, a layer and a stack of layers or two stacks of layers.

In various embodiments, a given applicator has a skin tissue contacting side 945. The skin contacting side comprises a substance sufficiently moist to conform to the stratum corneum therebetween. For example, in at least one embodiment, a thin adhesive that is sufficiently micro-conformable (i.e., "wet") to conform to the stratum corneum will work well to allow coupling into the skin. Thin adhesives help avoid air gaps, which can reduce how much current can be coupled into the body. The air space is filled with a water-based substance, preferably a water-based substance, and carries current-carrying ions, such as brine, as part of various treatment processes. For example, suitable materials may include hydrogels. In an alternative embodiment, a thin aggressive adhesive would also work, but should be made in a way that allows it to "wet" into the stratum corneum. In various embodiments, the applicator may be pre-wetted such that the cover is peeled off prior to applying the wet side to the skin of the subject. Various embodiments include removable covers, such as releasable liners, such as those shown in fig. 19A, 19B, 19C, 20A, and 20B.

For example, an electrically conductive hydrogel is loaded onto the side of the applicator facing the subject, which compensates for bumps, hair and adheres the applicator to the body of the subject. Hydrogels moisturize the skin and make it sticky or sticky. The alternative may be a conductive adhesive or a pressure sensitive adhesive. However, another embodiment may include a dry surface, and the subject's skin is wetted with a wetting substance (e.g., ultrasound gel, hydrogel), and then the applicator is held in place. In some embodiments, a bandage is wrapped around the applicator and all or part of the subject's body to ensure that the applicator remains in place. Such applicators may be less convenient because proper placement may require two practitioners to apply the applicator and/or a belt or wrap to hold the applicator in place.

Quick connection interface device

The applicator may be connected to a system, such as the RF-based systems shown in fig. 1A-1F, 8 and 12, using various types of interface devices, connectors and adapters. The relative placement of the applicator and the clip 920 is shown in fig. 23A-23C. An exemplary interface unit is shown in fig. 16. Additional views of the interface device are shown in fig. 23A-24F. 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 with respect to the interface device. In some embodiments, the applicator includes a plurality of electrical traces at its connection interface. The interface device is a spring biased clamp/clip, depending on the goal of matching the electrical traces with the corresponding interface device trace-specific connections. In this manner, when the interface is compressed, it opens to receive the terminal portion of applicator a shown in fig. 23C. 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 by alignment device 895. The alignment device 895 may include holes or other areas or shapes defined by the connectors 890 designed to mate with and align with connectors in the interface device 920, such as pins, grooves, etc. In other embodiments, the interface device may be used with other applicators disclosed herein. Fig. 23C shows the clip in an open position ready to receive and electrically connect with the electrical connector of a given applicator. Fig. 24A-24F show various views of the interface 918.

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.

Distributor function

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

In one embodiment, the switchbox/hub avoids the use of multiple umbilicals that may cause crosstalk/signal interference. In one embodiment, separators for two or more umbilicals may be used simultaneously.

Fig. 25A shows a dispensing system that includes an applicator local electric box that performs task routing RF from the generator and distributes it locally to individual electrodes to improve feedback control.

In various embodiments, the system shown in fig. 25B includes a power distribution box local to each applicator. The applicator and box combination receives RF from the generator through a second box. The architecture shown in fig. 25C also has a switchbox local to each applicator. However, in this embodiment, each of the switchgears is directly connected to the generator. These and other applicator connection schemes may be used with respect to the treatment system 100.

Exemplary RF-based processing methods

In various embodiments, a multi-zone/multi-zone applicator including one or more cuts and interior zones/ridges may be used to facilitate various treatment methods. These systems and methods may include various non-medically related cosmetic and/or aesthetic treatments, such as for skin tightening and/or shaping, such as by causing lipolysis. In one approach, templates are used to characterize one or more patient regions for treatment so that the patient and operator can agree on a treatment method and a target region. Once treatment is agreed upon, the patient may be marked and otherwise measured and evaluated to determine which applicator to use and various other treatment parameters, such as treatment time and target temperature range for uniform heating. Typically, the patient's body is marked to delineate a treatment area that will receive one or more RF-based applicators.

In one embodiment, the patient lies down (after attaching the neutral electrode pad or NEM) and prepares the subject using hydrogel pre-placed on the applicator using one or more of pressure sensitive adhesive pre-placed on the applicator, coats the patient with hydrogel and then applies it to the patient, and/or coats the patient with ultrasound gel, then the applicator, then the bandage to maintain 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 to select a small area on the navel (e.g., zone 5 in fig. 15C or a subset of the area such as zone 912) and then closes zone 5 in the GUI prior to processing.

During the initial heating phase, the operator selects a predetermined cyclic zone/zone activation scheme and then interrogates the tissue with RF to reach the target temperature. In one embodiment, each zone/region is heated for a set time, such as a maximum time, e.g., about 10 seconds, and then each zone is sequentially heated for 10 seconds until the target temperature is reached. In one embodiment, the target temperature is reached in about 1 to about 60 seconds. A threshold of 42 c may 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., 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 the treatment progresses, the applicator regions are interrogated according to an alternating pattern or scheme (e.g., cyclic, sequence based on region number, random, or otherwise) such that a given region/region is actively heated for a period of time, and then another region/region is switched and heated. In this manner, switching between different regions and actively heating them before switching to another region again may maintain a 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 region-by-region basis such that the tissue under a given region or region remains within the desired temperature region for a desired period of time, e.g., one region is interrogated for 10 seconds to place it within a range of about 42 ℃ to about 47 ℃ or about 42 ℃ to about 44 ℃, and interrogated multiple times during the treatment process such that a total treatment time of about 10 minutes to about 15 minutes is achieved.

In other embodiments, compressible foam is used to bias 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 cross-talk by providing a tacky but easily removable adhesive applicator for pre-positioning on the target treatment area. Crosstalk may be reduced by including one or more insulating, conductive, semiconductive, materials such as gels or materials or layers. When RF-based processing is performed using one or more electrodes and/or applicators, these layers may be doped or formed using various insulating, conductive, and semiconducting materials to reduce cross-talk or other electrical interference.

Fig. 26A-26F illustrate various views of an applicator constructed and arranged for use in the submental region (i.e., the neck and/or chin region) according to embodiments of the present disclosure. In one embodiment, the submental applicator comprises two or more regions. In one embodiment, the shape of the submental applicator may be a portion of a circle or ellipse, such as a half or a third or another portion of a semicircle, sector, or ellipse. Fig. 26A shows a top view of an RF-based flexible applicator 2600 for treating a submental region. Fig. 26B illustrates a bottom view of the applicator 2600 shown in fig. 26A. Fig. 26C and 26D show side views of the applicator 2600. Fig. 26E and 26F show rear and front views of an applicator 2600 described herein. The submental applicator may include one or more release liners, although such liners are optional to the applicators disclosed herein.

Fig. 27A shows an exploded view of the various layers of an applicator constructed and arranged for use in the submental region according to an embodiment of the present disclosure. Similar to the applicators shown in fig. 19A-19C, the applicator 2600 for treating the submental region (i.e., neck/chin) has multiple layers. As shown, the releasable liner 2740 is adjacent to or below the gel layer 2735. The insulation layer 2730 also serves to protect the interior region or ridge of the applicator. In some embodiments, thermal shields 2730 are optionally flared or tapered. The flexible applicator 2725 includes a conductive layer, a plurality of dielectric layers, and an adhesive layer. As discussed herein, the tag 2720 may be disposed on the applicator. In addition, another release liner 2715 may also be used. Fig. 27B and 27C show different views of an applicator having one or more release liners. The applicator electrical connector 2710 connects to a flexible applicator 2725. The system connects to the electrical connector 2710 using a mating connector 2705, which is also operable to provide strain relief.

Fig. 27B and 27C show two different perspective views of the applicator shown in fig. 27A.

Graphical user interface features

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

Fig. 28A and 28B depict a Graphical User Interface (GUI) for use with a system using an applicator, such as the applicator shown in fig. 15C, in accordance with various aspects of the present teachings. Fig. 28A shows GUI 2800 in communication with an applicator. GUI 2800 is displayed on a display of one of the

processing systems

100, 800, 1200 and is implemented using one or more software modules that receive input signals from the temperature sensor of the applicator. Fig. 28A shows the graphics/buttons oriented in the same manner as the areas on the applicator. FIG. 28B shows one of the buttons grayed out, which means that the area of the sensitive area has been closed.

In this embodiment, GUI 2800 configures/manages each zone of the applicator. In this case, buttons/controls 2805-1, 2805-2, 2805-3, 2805-4, 2805-5, and 2805-6 (typically 2805) correspond to six areas within the applicator. In other embodiments, the applicator may have more or less than six zones. Each button/control 2805 specifies a desired temperature for each zone. The controller 2810 may be used to modify the desired temperature of each zone or adjust the processing time. In addition, the GUI 2800 displays the processing time on the display 2815. As shown in fig. 28B, button/control 2805-2 grays out, indicating that the second zone has closed due to the close proximity of the sensitive area to the second zone. In various embodiments, GUI 2800 can deactivate one or more regions as needed.

All of the drawings filed herewith include one or more decorative features and views, each of which includes a solid line, any of which also encompasses and corresponds to and provides support for the solid line, or each of which includes a dashed line, any of which also encompasses and corresponds to and supports the solid line.

The use of the terms "comprising," "including," "having," or "having" is generally to be construed as open-ended and non-limiting unless otherwise specifically indicated.

The use of the singular herein includes the plural (and vice versa) unless specifically stated otherwise. In addition, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. Further, where the term "about" is used before a quantitative value, the present teachings also include the specific quantitative value itself, unless specifically stated otherwise.

It should be understood that the order of steps or order of performing certain actions is immaterial so long as the present teachings remain operable. Further, two or more steps or actions may be performed simultaneously.

Where a range or list of values is provided, each intervening value, between the upper and lower limit of that range or list of values, is considered individually and is encompassed within the disclosure as if each value was specifically recited herein. Moreover, smaller ranges between and including the upper and lower limits of the given ranges are contemplated and are encompassed within the present disclosure. The list of exemplary values or ranges is not a disclaimer of other values or ranges between and including the upper and lower limits of the given range.

It should be understood that numerous changes to the disclosed embodiments can be made without departing from the scope of the present teachings. Although the foregoing figures and examples refer to particular elements, this is intended to be exemplary and illustrative only and not limiting. It will be understood by those skilled in the art that various changes in form and details may be made to the disclosed embodiments without departing from the scope of the teachings encompassed by the appended claims.

The claims (modification according to treaty clause 19)

1. A Radio Frequency (RF) based processing system, comprising:

a flexible applicator comprising 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 define a plurality of incisions that,

an inner region and N regions extending from the inner region, wherein the plurality of cuts divide the applicator into the N regions.

2. The RF based processing system of claim 1 wherein N ranges from 2 to 12.

3. The RF based processing system of claim 1, wherein 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.

4. The RF-based processing system of claim 3 wherein one or more of the plurality of cuts terminate in one or more strain relief elements, wherein the interior region is adjacent to the one or more strain relief elements.

5. The RF based processing system of claim 1, wherein the inner region is a no-cut region, where N is 6.

6. The RF based processing system of claim 1, wherein the N regions comprise a first region and a second region, wherein each of the first region and the second region define one or more sections, boundaries, or cutouts that are substantially the same.

7. The RF based processing system of claim 1, wherein the plurality of layers comprises a tag, wherein the tag comprises N area identifiers, wherein each of the N area identifiers is disposed on one of the N areas.

8. The RF 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, substantially oval, substantially circular, pear-shaped, substantially pear-shaped, submental-shaped, and combinations thereof.

9. 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 disposed along the inner region.

10. The RF 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.

11. The RF based processing system of claim 10 further comprising an RF processing system including an RF generator having an operating frequency ranging from about 0.5MHz to about 10MHz, wherein the RF generator is in electrical communication with the electrical connector.

12. The RF based processing system of claim 9, wherein the applicator further comprises an electrical connector in electrical communication with one or more addressable regions of a conductive layer, the electrical connector comprising a plurality of electrical contacts, wherein the copper traces disposed along the interior region are in electrical communication with the electrical contacts.

13. The RF based processing system of claim 12, wherein copper traces arranged along the inner region are arranged in a series of three or more adjacent sections that increase in width in a direction toward the electrical connector.

14. The RF based processing system of claim 1, wherein 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 each region has an area greater than a first area disposed therein, wherein each first area is greater than each second area.

15. The RF based processing system of claim 10, further comprising an RF processing system including an interface device in communication with the RF processing system, the interface device including a clamp and a cable adaptor, wherein the clamp opens and closes to releasably connect and align an electrical connector, wherein the cable adaptor is in electrical communication with electrical contacts of the clamp.

16. The RF-based processing system of claim 1, wherein the area of the electrode ranges from about 50cm²To about 600cm²。

17. The RF based processing system of claim 1, further comprising a thermal shield layer, wherein the electrically conductive layer comprises an arrangement of electrical traces, wherein the thermal shield layer covers a portion of the interior region below which adjacent electrical traces span the portion.

18. The RF based processing system of claim 1 further comprising one or more temperature sensors per each of the N regions.

19. The RF based treatment system of claim 18, further comprising an RF treatment system in electrical communication with the applicator and each temperature sensor, further comprising a control system, wherein the control system selectively addresses each of the N zones according to one or more patterns to deliver RF energy in a sequence to promote uniform heating.

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

21. The RF based processing system of claim 1, wherein the plurality of layers further comprises one or more adhesive layers, a polyamide layer, and a hydrogel layer.

22. A method of treating tissue using an RF-based applicator, the method comprising:

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 cut and a second cut; and

during the initial heating period, RF energy is delivered from each of the plurality of zones according to an alternating or sequential addressing scheme to elevate tissue below the applicator to a target temperature.

23. The method of claim 22, further comprising: the inner spine region is shielded to avoid undesirable heating of target tissue located beneath the inner spine region of the applicator.

24. The method of claim 22, further comprising: controlling the transmission of RF energy such that one or more sensitive regions located below one or more of the plurality of regions are not interrogated with RF energy.

25. The method of claim 22, further comprising: controlling the transmission of RF energy such that one or more tissue regions underlying one or more of the plurality of regions are cosmetically treated to enhance or induce one or more of lipolysis, skin tightening, and cellulite reduction.

Claims

1. A Radio Frequency (RF) based processing system, comprising:

a flexible applicator comprising a plurality of layers,

the plurality of layers define a plurality of incisions that,

2. The RF based processing system of claim 1 wherein N ranges from 2 to 12.

6. The RF based processing system of claim 1, wherein the plurality of N regions comprises a first region and a second region, wherein each of the first region and the second region define one or more sections, boundaries, or cutouts that are substantially the same.

17. The RF-based processing system of claim 1, further comprising a thermal shield layer, wherein the electrically conductive layer comprises an arrangement of electrical traces, wherein the thermal shield layer covers a portion of the interior region below which adjacent electrical traces span and vary in density along the portion.

25. The method of claim 22, further comprising: controlling the transmission of RF energy such that one or more sensitive areas underlying one or more of the plurality of regions are cosmetically treated to promote or induce lipolysis, skin tightening, and cellulite reduction.