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

Abstract

To provide systems utilizing RF energy to treat a patient's skin or other target tissue at a depth below a tissue surface using RF energy.SOLUTION: A system for treating a patient's tissue, comprises: a source of RF energy; a treatment applicator comprising a plurality of treatment electrodes configured to be disposed in contact with a surface of a patient's tissue and to deliver RF energy thereto; at least one return electrode; a cooling mechanism for cooling the tissue surface in contact with the plurality of electrodes; and control means configured to measure impedance of each of at least two individually-addressable treatment electrodes. The control means is further configured to adjust treatment RF signals applied simultaneously to the at least two individually- addressable treatment electrodes on the basis of the impedance of the at least two individually- addressable treatment electrodes so as to maintain uniformity of heating in a target tissue disposed below the treatment applicator.SELECTED DRAWING: Figure 1A

Description

Related Applications

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 357,920, filed July 1, 2016, and U.S. Provisional Patent Application No. 62 / 514,778, filed June 2, 2017, the entire contents of each of which are incorporated herein by reference. [Technical field]

[0002] The present invention relates generally to systems and methods for treating a patient's skin (e.g., dermis, subcutaneous layer, etc.) and other target tissue, including tissue located deep below the tissue surface, with radio frequency (RF) energy. [Background technology]

[0003] Electrosurgical devices are known that apply RF energy to tissue to produce a variety of effects, including highly invasive procedures (e.g., ablating or vaporizing tissue) and minimally invasive procedures (e.g., gently heating the surface of the skin). Summary of the Invention [Problem to be solved by the invention]

[0004] However, for cosmetic and / or beauty applications, improved methods and systems are needed to apply RF energy uniformly and over a large area to, for example, improve the appearance of firmer / smoother skin (or to appear to be firmer) and / or reduce fat present in subcutaneous tissue (e.g., subcutaneous layer, etc.). [Means for solving the problem]

[0005] Described herein are systems and methods using RF energy to treat a patient's skin (e.g., dermis, subcutaneous layer, etc.) and other target tissues deep below the tissue surface. In various embodiments, the teachings herein may provide non-invasive RF-based treatments with or without water cooling to achieve, for example, but not limited to, body sculpting (lipolysis), skin tightening (reducing laxity), cellulite treatment devices, vaginal laxity treatment or rejuvenation, urinary incontinence treatment, fecal incontinence treatment, and other urogenital conditions.

[0006] In various embodiments, non-invasive treatment of unwanted fat, improvement of skin laxity / tightness, and improvement of the appearance of cellulite may be achieved by applying RF energy (e.g., 500 kHz, 1 Mhz, etc.) to the surface of a patient's tissue (e.g., skin, vaginal wall, esophagus, etc.) with a water-cooled treatment electrode or treatment electrode array operating in a monopolar or bipolar manner, and propagating the RF energy from the tissue surface to deeper tissue layers. In various embodiments of the present teachings, cooling the superficial layers and selectively controlling the application of RF energy may heat tissue beneath the surface and help ensure uniformity of heating, patient safety and tolerability, and consistent clinical efficacy.

[0007] In various aspects of the teachings of the present application, the systems and methods described herein include: 1. User-friendly and / or hands-free (e.g., after the initial set-up ("priming")); 2. Improving patient tolerance by providing patient safety and / or comfort through cooling of the upper layers of tissue and / or modulation of RF energy and / or modulation of cooling; and 3. Flexibility to accommodate a variety of anatomical structures; For example, the systems and methods of the teachings herein may be used in a hands-free fashion, where the RF application means or means are applied to the patient at the beginning of the treatment and the energy is turned on until the treatment is completed, possibly without any intervention (e.g., the patient may be left substantially motionless for the treatment for 5 minutes or more, 10 minutes or more, etc., after the initial set-up). In various embodiments, the methods and systems described herein may include a cooling system (e.g., by circulating temperature-controlled cold water in the vicinity of the RF source and / or electrode array) to provide patient safety in compliance with recommended FDA and / or IEC safety standards (e.g., to prevent skin burns and / or formation of nodules in tissue following tissue heating treatment) and / or to improve patient comfort and / or improve patient tolerance to the pain of the RF energy during the treatment. In various embodiments, the methods and systems described herein may be sufficiently flexible and / or adaptable to treat a variety of desired locations on a patient's body (e.g., abdomen, under the chin, etc., or any of the many locations on the face, arms, legs, etc.) despite anatomical variations between and within patients, differences in surface area, and complex curvatures that may make it difficult to maintain contact for the period of time required to complete treatment.

[0008] Various aspects of the teachings of the present invention provide a system for treating tissue of a patient, the system comprising an RF energy source, a treatment applicator including a plurality of treatment electrodes configured to be placed in contact with a surface of the patient's tissue (e.g., a skin surface, a mucosal surface, etc.) and to deliver RF energy to the tissue surface, and a return electrode. The plurality of treatment electrodes can include at least two individually addressable treatment electrodes to which different treatment RF signals can be applied, the treatment RF signals representing one or more of power, duty cycle, pulse length (pulse width, pulse duration), phase, and RF frequency. The system can further include a control means configured to measure (determine) an impedance of each of the at least two individually addressable treatment electrodes, the control means further configured to adjust the treatment RF signals simultaneously applied to the at least two individually addressable treatment electrodes based on the impedance of the at least two individually addressable treatment electrodes to maintain uniformity of heating in a target tissue located below the treatment applicator. Optionally, in some aspects, the system may further comprise a cooling mechanism for cooling the tissue surface in contact with the plurality of electrodes. In various aspects, at least one of the return electrodes may be placed on the surface of the skin or internally within the body (e.g., in the urethra, etc.).

[0009] In some aspects, the different RF signals simultaneously applied to the at least two individually addressable treatment electrodes may have one or more of different powers, different pulse widths, different duty cycles, different phases, and different RF frequencies. In some related embodiments, the control means may be configured to reduce the power of the RF signal to an electrode of the at least two individually addressable treatment electrodes having a lower impedance.

[0010] In various aspects, the at least two individually addressable treatment electrodes can include at least two groups (e.g., clusters, etc.) of individually addressable treatment electrodes, where each treatment electrode in each group of individually addressable treatment electrodes is configured such that the RF signal simultaneously applied to each treatment electrode is the same as the other treatment electrodes in the group, and each group of individually addressable treatment electrodes is configured such that the RF signal simultaneously applied to each treatment electrode is different from the other groups of individually addressable treatment electrodes.

[0011] In some aspects of the teachings of the present invention, the system may further include a second treatment applicator configured to be placed in contact with a tissue surface separate from the tissue surface on which the first treatment applicator is placed. In some aspects, the second treatment applicator may be the at least one return electrode (although the return electrode may be a separate electrode). Optionally, the second treatment applicator may include a cooling mechanism for cooling the tissue surface in contact with the electrodes of the second treatment applicator. In some aspects, the second treatment applicator may include a second plurality of treatment electrodes configured to be placed in contact with a tissue surface that is a surface of a patient's tissue and to deliver RF energy to the tissue surface, the second plurality of treatment electrodes having at least two individually addressable treatment electrodes to which different RF signals can be applied. In such an embodiment, the control means may be configured, for example, to energize only one of the individually addressable treatment electrodes in each of the first and second treatment applicators at a given time (moment). The control means may also be configured to measure the impedance between each of the at least two individually addressable treatment electrodes in the first treatment applicator and each of the at least two individually addressable treatment electrodes in the second treatment applicator (e.g., by polling electrodes from each applicator one by one). For example, the control means may be configured to measure the impedance between each of the at least two individually addressable treatment electrodes in the first treatment applicator and each of the at least two individually addressable treatment electrodes in the second treatment applicator by generating a sub-treatment threshold RF current therebetween before applying a treatment RF signal to the first of the plurality of electrodes.In some embodiments, in addition or alternatively, the control means may be configured to measure impedance between each of the at least two individually addressable treatment electrodes on the first treatment applicator and each of the at least two individually addressable treatment electrodes on the second treatment applicator while applying a treatment RF signal to a first of the plurality of electrodes to determine when to stop the treatment RF signal and terminate treatment.

[0012] The return electrode may take a variety of configurations. For example, the return electrode may be a passive electrode configured to be placed in contact with a tissue surface remote from the tissue surface on which the first treatment applicator is placed. For example, the passive electrode may be a neutral drain pad. In some related aspects, in addition to the return electrode, a second treatment applicator may be provided configured to be placed in contact with the tissue surface on which the first treatment applicator is placed and a tissue surface remote from the tissue surface on which the passive electrode is placed, the second treatment applicator including a second plurality of treatment electrodes configured to be placed in contact with a tissue surface that is a surface of a patient's tissue and to deliver RF energy to the tissue surface.

[0013] In various aspects, the control means may be configured to individually poll each of at least two individually addressable treatment electrodes in a first of the treatment applicators with a low power sub-treatment threshold RF signal.

[0014] Methods and systems according to the teachings of the present invention may perform a variety of treatments. For example, the treatment RF signal may be configured to reduce skin laxity by stimulating collagen production and / or lipolysis of adipose tissue underlying the tissue surface (e.g., by general (bulk) heating, etc.). For example, each electrode may be configured to provide a power of approximately 1 W / cm 2 ~about 5 W / cm 2and the pulse width of the RF signal is greater than about 1 second. Additionally or alternatively, the treatment RF signal can be configured to reduce the appearance of cellulite. For example, each electrode can be configured to deliver an RF power in the range of about 10 J / cm2 of energy per pulse. 2 ~about 1000 J / cm 2 , wherein the pulse width of the RF signal is less than about 500 milliseconds.

[0015] The cooling mechanism of the teachings of the present invention may take a variety of configurations. For example, the cooling mechanism may include a circulating fluid, or a thermoelectric element or phase change material disposed in thermal contact with the electrodes in the applicator. In some embodiments, the cooling mechanism may include a circulating fluid, the temperature of which is controlled by a temperature regulating means (e.g., under the influence of the control means) such that a target tissue region located beneath the tissue surface is maintained at a temperature within a range of about 42°C to about 47°C for a treatment time within a range of about 10 minutes to about 30 minutes. In some embodiments, the circulating fluid may be water. In various embodiments, at least a portion of the fluid path of the circulating fluid may be in thermal contact with a side of the electrode not configured to contact 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 electrodes of the plurality of treatment electrodes.

[0016] In various aspects, the system may further comprise at least one temperature detection means for detecting a temperature of the tissue surface at the periphery of the electrode array, and the control means may be further configured to adjust the RF signal applied to the electrodes on the hottest side of the applicator (e.g., to decrease the power of the treatment RF signal). Additionally or alternatively, the control means may be configured to adjust the RF signal applied to the electrodes on the side of the applicator opposite the coolest side of the applicator (e.g., to increase the power of the treatment RF signal).

[0017] In some embodiments, the RF energy source can include at least two individually controllable RF energy sources, each configured to operate at the same fundamental frequency, while the RF signal generated by each of the individually controllable RF energy sources can be of different phase and amplitude. In such embodiments, the system can include at least two treatment applicators, each connected to one of the RF energy sources, and current can be shared between the at least two treatment applicators to enable the at least two applicators to be positioned at two or more separate treatment areas of a subject's body, and each of the at least two applicators can be configured to deliver an appropriate amount of RF energy to each of the separate treatment areas.

[0018] Various aspects of the teachings of the present invention provide a system for treating tissue of a patient, the system comprising an RF energy source, a treatment applicator including a treatment electrode configured to be placed in contact with a tissue surface that is a surface of the patient's tissue and to deliver RF energy to the tissue surface, and at least one return electrode. The system may further comprise a control means configured to provide an RF signal to the treatment electrode, the RF signal having a pulse length that selectively heats septa in fatty tissue while substantially preventing conduction of heat to nearby tissue, and an impedance tracking means that monitors the impedance of the patient's tissue during the pulse length and provides information about changes in the impedance of the patient's tissue to the control means so that the control means can terminate the RF signal when a desired treatment is completed. Optionally, the system may comprise a cooling mechanism for cooling the tissue surface in contact with the electrode.

[0019] In various related embodiments, the treatment electrode has an energy per pulse of about 10 J / cm. 2 ~about 500 J / cm 2 , and the pulse width of the RF signal is less than about 500 milliseconds. In some embodiments, the control means may further adjust the RF signals provided to the electrodes such that a second treatment RF signal is simultaneously provided to the electrodes, the second RF signal having a lower RF power and a longer pulse width than the treatment RF signal for selectively heating the septum. For example, the second treatment RF signal may be configured to reduce skin laxity and / or induce lipolysis (after or before the septum is selectively targeted). In various embodiments, the second treatment RF signal is configured to deliver about 1 W / cm2 of RF power to each electrode. 2 ~about 5W / cm 2 , and the pulse width of the RF signals is greater than about 1 second.

[0020] Various aspects of the teachings of the present invention provide a system for treating tissue of a patient, comprising: an RF energy source; and a treatment applicator including a plurality of treatment electrodes configured to be placed in contact with a tissue surface of the patient's tissue and to deliver RF energy to the tissue surface, the plurality of treatment electrodes having at least two individually addressable treatment electrodes to which a treatment RF signal can be applied. In some aspects, the system may further comprise at least one return electrode, and may optionally comprise a cooling mechanism for cooling the tissue surface in contact with the plurality of electrodes. A control means may be provided configured to sequentially supply treatment RF signals to the at least two individually addressable treatment electrodes such that each of the at least two individually addressable treatment electrodes selectively heats a septum in adipose tissue while substantially preventing conduction of heat to nearby tissue. In some aspects, each of the at least two individually addressable treatment electrodes is configured to receive a treatment RF signal having an energy of about 10 J / cm. 2 ~about 500 J / cm 2 , and the pulse width of the RF signal is less than about 100 milliseconds. The control means is further adapted to adjust the RF signals provided to the electrodes such that a second treatment RF signal is simultaneously provided to the electrodes, the second RF signal having a lower RF power and a longer pulse width than the treatment RF signal for selectively heating the septum. For example, the second treatment RF signal may be configured to reduce skin laxity and / or induce lipolysis. In one embodiment, each electrode receiving the second treatment RF signal has a power of about 1 W / cm2. 2 ~about 5 W / cm 2 can be delivered simultaneously, with the pulse width of the RF signal being greater than about 1 second.

[0021] In various aspects of the teachings of the present invention, a device for treating a female urogenital condition is provided, comprising a probe adapted for vaginal insertion 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 emitting therapeutic electrodes arranged in an array at the distal end of the probe to heat tissue in contact with or in proximity to the probe. Additionally, at least one temperature sensor may 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 realized by one or more of the electrodes operating as impedance measuring electrodes. Optionally, the probe may further include at least one cooling circuit to prevent overheating of the vaginal wall surface.

[0022] In some embodiments, the electrodes are programmable (e.g., under the influence of a control means) to allow some of the elements of the array to be energized to deliver heat in a particular pattern. In various embodiments, the device may further comprise at least one return electrode to provide a return path for RF current from the therapeutic electrode. For example, the return electrode may be a drain pad (e.g., a neutral paddle, etc.) adapted to be placed on an external surface of the patient's body (e.g., on the surface of the skin, etc.). Alternatively, the return electrode may be provided on a urinary catheter. Alternatively, the return electrode may be realized by one or more electrodes in the array functioning as a ground electrode.

[0023] In certain embodiments, a fixation device may be provided to facilitate insertion of the probe and / or to hold the probe in place once inserted into the patient. For example, the fixation device may include a locking sleeve or balloon.

[0024] In various aspects of the teachings of the present invention, a method for treating a female urogenital condition is provided. For example, in various aspects, a method for treating stress urinary incontinence (SUI) is provided, comprising delivering a controlled amount of heat to a vaginal wall surface to reshape tissue in a target area near the patient's bladder neck or urethra. In various aspects, the heating may be achieved by energizing at least one radio frequency (RF) energy emitting therapeutic electrode in contact with the vaginal wall surface to deliver RF current to the target area. In an exemplary aspect, the therapeutic electrode may include an electrode array carried by a probe, and the method further comprises inserting the probe into the patient such that at least one therapeutic electrode contacts at least a portion of the vaginal wall surface. In some aspects, the power delivered by individual electrodes in the array may be varied to ensure uniform heating of tissue in the target area. In some embodiments, the at least one electrode can be configured to contact at least a portion of the anterior vaginal wall, and / or the method can further include delivering RF energy to heat tissue between the patient's vaginal wall surface and the urethra. For example, the method can further include delivering RF energy to heat tissue in a target area extending beyond the inner vaginal wall surface to a treatment depth of about 2-9 cm, preferably about 5-8 cm.

[0025] In some related aspects, RF energy can be delivered to heat tissue in the target area for a period of time, preferably less than 30 minutes or less than 10 minutes, and in some cases less than 5 minutes. Also, in some aspects, the target tissue can be heated to about 40-45° C. or about 41-43° C. Optionally, the method can include cooling the vaginal wall surface before, after, or during heating of the tissue in the target area.

[0026] In various embodiments, the method may further comprise mapping the heating effect of the RF electrodes by thermal imaging or impedance measurements.

[0027] Various aspects of the teachings of the present invention provide a system for treating tissue of a patient, the system comprising an RF energy source, a treatment applicator (e.g., a treatment probe including at least one treatment electrode and configured for insertion into a patient's vagina) including treatment electrodes configured to be placed in contact with a tissue surface of the patient's tissue and to deliver RF energy to the tissue surface, and at least one return electrode. The system may further comprise a control means configured to provide an RF signal to the treatment electrode, the pulse length of the RF signal and the dimensions of the treatment electrode being set to apply a current density sufficient to cauterize (remove, ablate) the surface of the tissue in contact with the treatment electrode. Optionally, a cooling mechanism may be provided to cool the tissue surface in contact with at least one of the electrodes. In various aspects, the pulse length may be less than about 100 milliseconds (e.g., in the range of about 5 milliseconds to about 35 milliseconds). In various embodiments, the dimensions of at least one of the treatment electrodes can range from about 0.1 mm to about 10 mm, or from about 0.1 mm to about 5 mm.

[0028] In various embodiments, the system may further include a second treatment electrode that may be disposed proximate the treatment electrode, and the control means may further be configured to provide the RF signal to the second treatment electrode, the pulse length of the RF signal and the dimensions of the second treatment electrode being set to apply a current density sufficient to remove the surface of the tissue in contact with the treatment electrode. In various embodiments, the pitch between the treatment electrode and the second electrode may be within a range of about 0.1 mm to about 10 mm, or about 0.5 mm to about 5 mm. In some related embodiments, the treatment electrode may be addressed by the control means simultaneously with the second treatment electrode.

[0029] In various embodiments, the treatment electrode may have a cluster of at least two electrodes, each of the electrodes in the cluster having a dimension ranging from about 0.1 mm to about 10 mm, or from about 0.1 mm to about 5 mm. In such embodiments, the dimensions of each of the at least two electrodes in the cluster may be set to apply a current density sufficient to remove the surface of the tissue in contact with each treatment electrode of the cluster. In some embodiments, a second cluster of at least two electrodes may be provided, and the control means is configured to provide the RF signal to the second cluster, and the pulse length of the RF signal and the dimensions of each of the at least two electrodes in the second cluster are set to apply a current density sufficient to remove the surface of the tissue in contact with each treatment electrode of the second cluster. In various embodiments, the control means may address the cluster and the second cluster separately.

[0030] In various aspects of the teachings of the present invention, a system for treating tissue of a patient is provided, the system comprising at least two treatment applicators each configured to be placed on a tissue surface and at least two individually controllable RF energy sources. In an exemplary aspect, each of the individually controllable RF energy sources may operate at the same fundamental frequency, while the phase and amplitude of each of the at least two RF energy sources may be relatively controllable. In such an aspect, each of the at least two treatment applicators may be connected to an individually controllable RF energy source, and current may be shared between the at least two treatment applicators to enable the at least two applicators to be placed on two or more separate treatment areas of a subject's body, and each of the at least two applicators may be capable of delivering an appropriate amount of RF energy to each of the separate treatment areas. In various aspects, the system may further comprise a return electrode. Additionally, in one aspect, each of the treatment applicators can include a plurality of treatment electrodes configured to be placed in contact with a tissue surface that is a surface of a patient's tissue and to deliver RF energy to the tissue surface, the plurality of treatment electrodes having at least two individually addressable treatment electrodes to which an RF signal can be applied.

[0031] These and other configurations of applicants' teachings are described herein.

[0032] Those skilled in the art will appreciate that the following drawings are merely illustrative and are not intended to limit the scope of the applicant's teachings. [Brief description of the drawings]

[0033] [Figure 1A] 1A-1C are schematic diagrams illustrating exemplary systems for performing RF treatment of various target regions of a patient's body, in accordance with various aspects of the present teachings. [Figure 1B]1B is a schematic diagram of an exemplary further embodiment of the system of FIG. 1A according to various aspects of the present teachings. [Figure 1C] 1A-1C are schematic diagrams illustrating an exemplary system for performing RF treatment of a target region of a patient's body using a tip electrode in accordance with various aspects of the present teachings. [Figure 1D] FIG. 2 is a schematic diagram of another exemplary system for performing RF treatment of a target region of a patient's body using an electrode array, in accordance with various aspects of the present teachings. [Figure 1E] FIG. 2 is a schematic diagram illustrating another exemplary system for performing RF treatment of a target region of a patient's body using two electrode arrays, in accordance with various aspects of the present teachings. [Diagram 2] 1A-1C are schematic diagrams illustrating an exemplary disposable system for performing RF treatment of a target area of ​​a patient's body in accordance with various aspects of the present teachings. [Diagram 3] 1A-1C are schematic diagrams illustrating an exemplary system for cooling a flexible electrode array and / or a patient's skin in accordance with various aspects of the present teachings. [Figure 4] FIG. 1 illustrates an exemplary electrode array according to various aspects of the present teachings, which can be individually addressed according to an exemplary technique for monitoring and / or controlling the distribution of RF energy applied by the electrode array. [Figure 5A] 1A-1D are schematic diagrams illustrating an exemplary septum-targeted treatment in accordance with various aspects of the present teachings. [Figure 5B] 1A-1C are schematic diagrams illustrating other exemplary procedures targeting the septum, in accordance with various aspects of the present teachings. [Figure 5C] 13A-13C are schematic diagrams illustrating yet another exemplary treatment targeting the septum, in accordance with various aspects of the present teachings. [Figure 5D] 13A-13C are schematic diagrams illustrating yet another exemplary treatment targeting the septum, in accordance with various aspects of the present teachings. [Figure 5E]1A-1C illustrate exemplary techniques for monitoring and / or controlling distribution of RF energy in accordance with various aspects of the present teachings. [Figure 5F] FIG. 13 illustrates another exemplary technique for monitoring and / or controlling the distribution of RF energy in accordance with various aspects of the present teachings. [Figure 6A] 1 is an exemplary plot of tissue temperature in a target region including a fatty region of relatively uniform thickness during an exemplary treatment in accordance with various aspects of the present teachings. [Figure 6B] 1 is an exemplary plot of tissue temperature in a target region including a fatty region of relatively non-uniform thickness during an exemplary treatment in accordance with various aspects of the present teachings. [Figure 6C] FIG. 13 shows a schematic diagram of the shift of the treatment zone due to the relatively non-uniform thickness of the fat region during RF treatment. [Figure 6D] FIG. 13 is an exemplary plot of tissue temperature due to a moving treatment zone in a fatty region of relatively non-uniform thickness during RF treatment. [Figure 6E] 1 is an exemplary plot of tissue temperature in a target region and after correction for treatment zone movement during RF treatment of a fatty region of relatively non-uniform thickness in accordance with various embodiments of the present teachings. [Figure 7A] 1A-1C are plots of RF power and temperature in a target region at a depth of 1.5 cm during an exemplary treatment in accordance with various embodiments of the present teachings. [Figure 7B] FIG. 7B is a plot of tissue impedance using different cooling temperatures during the exemplary procedure of FIG. 7A. [Figure 7C] FIG. 2 illustrates exemplary electronic components of an applicator including an electrode array in accordance with various aspects of the present teachings. [Figure 8] FIG. 1 is a schematic perspective view of a system for treating a urogenital condition, in accordance with various aspects of the present teachings. [Figure 9] 1 is a schematic perspective view of a probe and introducer according to various aspects of the present teachings; [Figure 10A] FIG. 1 is a schematic diagram of the female urogenital tract. [Figure 10B] FIG. 1 is a schematic diagram of the female urogenital tract showing insertion of a monitoring catheter into the urethra. [Figure 10C] 1 is a schematic diagram of the female urogenital tract illustrating the insertion of a vaginal treatment probe in accordance with various aspects of the present teachings. [Figure 11] 1A-1C are schematic diagrams of a probe operating in two different modes in an exemplary embodiment of the present teachings. [Figure 12] 1 is a schematic diagram of an RF system with exemplary electronics in accordance with various aspects of the present teachings. [Figure 13] 1A-1D illustrate an exemplary partial ablation procedure in accordance with various aspects of the present teachings. [Figure 14A] 1A-1C are diagrams illustrating the results of an exemplary partial ablation procedure using certain pulse lengths in accordance with various aspects of the present teachings. [Figure 14B] 1A-1C illustrate the results of an exemplary partial ablation procedure using different pulse lengths in accordance with various aspects of the present teachings. [Figure 14C] 1A-1C illustrate the results of an exemplary partial ablation procedure using different pulse lengths in accordance with various aspects of the present teachings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] In the following description, various aspects of the embodiments of the applicant's teachings will be described, but for clarity, some specific details will be omitted if convenient or appropriate. For example, the description of similar or similar configurations / components in alternative embodiments (variations) may be somewhat simplified. Also, well-known ideas and concepts may not be described in detail for clarity. Those skilled in the art will appreciate that some embodiments of the applicant's teachings may not require some details as specifically described in each application example (such details are merely provided to enhance understanding of the embodiments). Similarly, it is clear that the described embodiments may be modified or changed according to common sense without departing from the scope of the invention. The following detailed description of the embodiments is not intended to limit the scope of the applicant's teachings.

[0035] The terms "about" and "approximately the same" as used herein refer to variations in quantities that may occur due to, for example, real-world measurement or handling processes; inadvertent errors during these processes; individual differences / failures in the manufacture of electrical components; low electrical losses; and the like, as well as variations that one of ordinary skill in the art would consider equivalent (but only if they do not include known values ​​practiced in the prior art). Typically, the term "about" refers to a stated value or range of values ​​that is about 1 / 10th of the stated value (e.g., ±10%). For example, applying a DC voltage of about +3 V may mean a DC voltage of +2.7 V to +3.3 V. Similarly, when a value is "approximately the same," it means that the value may vary by up to 5%. In the case of a numerical value described in a claim, whether or not it is modified by the terms "about" or "approximately the same," it is intended to include an equivalent value to the stated numerical value (e.g., a variation in the amount of variation that one of ordinary skill in the art would consider equivalent (e.g., a variation in the amount of variation that may occur for such a numerical value).

[0036] As described in more detail below, systems and methods are provided for treating a patient's skin (e.g., dermis, subcutaneous layer, etc.), a patient's mucosal tissue surface (e.g., vaginal tissue surface, esophageal tissue surface, etc.), or other target tissue including tissue deeper below the tissue surface (e.g., skin surface, vaginal or esophageal mucosa surface, etc.), which may generally include at least one RF energy source (e.g., RF generator, etc.), a treatment applicator including at least one electrode array configured to be placed in contact with the tissue surface, and a return electrode (e.g., indifferent electrode, etc.) coupled (tethered) to the tissue surface.

[0037] In various embodiments, the systems and methods may apply RF energy (e.g., 500 kHz, 1 Mhz, etc.) to the surface of a patient's tissue (e.g., skin, vaginal wall, esophagus, etc.) via a treatment electrode or treatment electrode array (optionally water cooled), and the RF energy propagates from the surface to deeper tissue layers and back to the RF generator through a return electrode (e.g., a large surface area neutral pad, etc.) that is coupled to the tissue surface at a location remote from the treatment electrode or treatment electrode array, thereby treating unwanted fat (e.g., by lipolysis, etc.), improving loose / tight skin (e.g., by stimulating collagen, etc.), improving the appearance of cellulite (e.g., by disrupting the septum, etc.), and treating various urogenital conditions. In various aspects of the present teachings, the systems and methods provide for the generation of a relatively large area (e.g., approximately 24 cm2) of tissue by placing (e.g., positioning, securing, etc.) an applicator on the skin, providing energy to the device (e.g., energizing the RF generator, etc.), and selectively controlling the delivery of RF energy to heat tissue beneath a superficial layer while cooling the superficial layer. 2 Super, about 50 cm 2 Super, about 200 cm 2In one embodiment of the present teachings, the target tissue (such as a vascular endothelial cell) is heated with RF energy. In various embodiments of the present teachings, the delivery of RF energy and / or cooling of the tissue can be performed such that the tissue beneath the surface is heated substantially uniformly. As can be appreciated from the present teachings, uniformity of heating can be necessary to aid in safety, patient tolerance, and consistent clinical outcomes.

[0038] 1A and 1B, which diagrammatically illustrate an exemplary system 100 in accordance with various aspects of the present teachings. As shown, the system 100 generally includes a console 110, at least one applicator 130a-130d including at least one conductive electrode (e.g., an electrode made of metal, etc.) configured to be placed in electrical contact with a patient's tissue (e.g., tissue proximate to an area to be treated, etc.) to apply RF energy to a surface of the tissue, and a return electrode (e.g., neutral / drain pad 130e, FIG. 1A, active electrode array 160, FIG. 1B, etc.). The console 110 may take a variety of configurations, but may include a display 132 (e.g., allowing for reporting and / or control of various treatment parameters) and a housing 134 that houses at least one RF energy generator 135, 136, a temperature controlled water circulation means 138 (e.g., including a chiller and / or heater), and a power supply 139 (e.g., a constant voltage power supply, etc.), including, but not limited to, these examples. In accordance with the teachings herein, the system 100 further includes a controller 137 (e.g., including a CPU or microprocessor) that controls the operation of the RF energy generators 135, 136 and / or the application of RF energy to specific electrodes 162 and / or the water temperature regulation / circulation means 138. As shown, the console 110 may have multiple ports (e.g., CH1-CH4, etc.) for electrical and fluidic connection to the applicators 130a-130d, as well as an additional port for electrical connection to the drain pad return 130e. As described in more detail below, for example, each applicator 130a-130d may be equipped with a cold water attachment and electrical connections to support serial communications between the console 110 and the applicator 130a-130d, and each applicator is connected to the console 110 by a respective cable or umbilical 133.

[0039] At least one RF generator 135, 136 is generally configured to generate energy that is delivered through at least one transmission line extending through umbilical 133 to at least one applicator 130a-130d for application to tissue (e.g., after conditioning by distribution electronics within the applicator 130a-130d) and may be any known or future developed RF energy source modified in accordance with the teachings of the present invention. Exemplary commercially available RF sources suitable for modification in accordance with the teachings of the present invention include the ForceTriad® energy platform sold by Covidien. In some embodiments, multiple RF energy generators may be provided, each configured to generate RF energy with different characteristics, such that one or more of the generators may be utilized alone or in concert depending on the desired treatment. As shown in FIG. 1A, the system 100 includes two generators, a generator 135 (operable at 100% duty) capable of generating RF energy at 1 MHz with a maximum power of 300 W, and a generator 136 (operable at 20% duty) capable of generating RF energy at 1 MHz with a maximum power of 1 kW, (but not limited to these examples). Those skilled in the art will appreciate from the teachings of the present invention (as discussed elsewhere herein) that the various parameters of the RF energy (maximum power, frequency, duty ratio, pulse length, etc.) can be selected depending on the desired treatment and treatment area. For example, one or more of the multiple RF generators 135, 136 can be adjusted to provide various powers, e.g., about 200 cm. 2 1B ) and a return electrode (e.g., 130b, etc., in FIG. 1B ) configured to cover 2 2) for 300 W of RF energy (i.e., approximately 1.5 W / cm per applicator). 2 ) (each applicator 130a, 130b provides approximately 1.5 W / cm 2 It is possible to provide

[0040] As discussed elsewhere herein, other suitable RF energy generators may be used, for example, a suitable RF energy generator may have a power of about 0.5 W / cm. 2 ~about 5W / cm 2 A non-limiting example of a duty cycle may provide a wattage range of 100 Hz to 100 Hz. In various embodiments, the preferred duty cycle may vary depending on the type of tissue targeted, but in some exemplary tissue heating applications, the goal may be to keep treatment time to a minimum while still providing an amount of RF energy that will cause a temperature rise. Thus, if the duty cycle is reduced, the RF energy may be increased to compensate for the reduced "on time" so as not to increase the total treatment time. An exemplary duty cycle for heating skin or fat is about 30% to about 80% (e.g., about 50% RF duty cycle is 5 seconds on followed by 5 seconds off). The duty cycle may be modulated at various frequencies in the microsecond to second range, as some applications may allow for a faster modulation cycle to allow for more precise control, while other applications may require a longer modulation cycle. The duty cycle may also be modulated to optimize energy deposition for different tissue layers or tissue types. Anatomically speaking, a relatively long duty cycle (e.g., 80% duty cycle instead of 30%) may be possible for large volume, deep, highly perfused tissue target regions (e.g., fat, etc.), whereas a relatively short duty cycle (e.g., 30% duty cycle is preferable to 80% duty cycle) may be required for small volume, shallow, poorly perfused tissue (e.g., skin, etc.). For applications other than general (bulk) heating, such as selecting target tissue based on tissue impedance, very short duty cycles (possibly even less than 1%) may be highly beneficial. Such short duty cycles may also be characterized as (or referred to as) pulsed RF.

[0041] 1A and 1B, an exemplary system 100 includes multiple applicators 130a-130d, which are versatile, stand-alone systems for safely and effectively heating and / or cooling tissue. In various aspects, reducing and / or maintaining the temperature of the surface of the patient's skin tissue, such as by flowing water adjacent a relatively rigid applicator (e.g., applicators 130a, 130b, etc.) or a flexible applicator (e.g., applicator 130c, which is adhesively attached to the skin), may be important to maintain the safety and comfort of the patient. As shown generally, each applicator 130a-130c may include, by way of non-limiting example only, a relatively rigid or flexible applicator body, dispensing electronics, a water receiving or housing, an electrode array, and an adhesive to aid in securing at least one of the applicators 130a-130c to the patient's skin. In some embodiments, a vacuum may be used to assist in securing the at least one applicator to the skin. As described below, the applicators 130a-130c may have a variety of configurations, but are generally configured to couple to a tissue surface of a patient, and RF energy provided to the applicators 130a-130c may be applied to the tissue of the patient via at least one electrode disposed adjacent to the tissue surface. The at least one applicator 130a-130c may also have a variety of configurations. For example, in the exemplary system 100 of FIGS. 1A and 1B, the applicators 130a, 130b may be substantially identical to each other, with one electrode array functioning as a treatment electrode array and the other electrode array forming a closed circuit as the return electrode. In various embodiments, the system 100 can be operated in a monopolar manner in which a circuit is formed by a source electrode 162a in a given electrode array 160a from one applicator (e.g., 130a in FIG. 1B ) and a return electrode 162b in another electrode array 160b from the other applicator (e.g., 130b in FIG. 1B ).In some embodiments, a drain pad 130e (also referred to herein as a "return electrode") having a large surface area may be attached to the tissue surface at a location remote from the treatment applicators 130a-130d to disperse and / or return RF energy applied to the patient's tissue from one or more of the "active" applicators 130a-130d as shown in FIG. 1A. As discussed elsewhere herein, while the tissue may reach a clinical endpoint in some electrode arrays, the dose may not yet be fully delivered in other arrays due to anatomical differences. In such cases, it may be possible to increase the relative temperature of the delayed area by utilizing a power drain to the auxiliary return electrode 130e. In some alternative embodiments, bipolar operation may be achieved by energizing multiple electrodes within an applicator array (e.g., array 160a of applicator 130a, etc.). As described elsewhere herein, the applicator 130c may also include an electrode array and may be relatively rigid, while having a shape configured to fit a particular body region, as shown in FIG. 1A. For example, but not limited to, the applicator 130c may include an electrode array in a recess that may be configured to receive the patient's chin, such that contact between the surface of the skin and the surface of the electrode is substantially maintained when coupled to the patient's chin. Alternatively, the applicator 130c may be relatively flexible so that it can conform to curved tissue surfaces (e.g., the chin, chin skin, neck, abdomen, etc.). As described elsewhere herein, an applicator handpiece 130d may be provided that includes at least one electrode that may be operated in a stamping manner, as shown in FIG. 1A. For example, the applicator 130d may be capable of applying at least one RF pulse to a tissue surface in a particular treatment area while being applied to the tissue surface.In some embodiments, the applicator 130d may be configured to apply at least one high power RF pulse with a short pulse length and may utilize one or more of impedance mapping, impedance tracking, and temperature monitoring as described elsewhere herein. After treatment of a particular area, the handpiece applicator 130d may be moved to another location. Also, as can be understood from the teachings of the present invention, three or more applicators may be used to cover a larger area.

[0042] 1C-1E, at least one electrode of another exemplary applicator in the case of an electric treatment unit (ESU) system 100 with a console 110 (a console modified according to the teachings of the present invention from a console known in the art). For example, as shown in FIG. 1C, the ESU 100 may be configured to focus RF power and tissue heating to a tip electrode 162d (e.g., a single electrode with a small surface area) of an applicator 130d (e.g., an applicator configured to be applied to a tissue surface of a patient and operate in a stamping manner), while using a drain pad 130e with a relatively large surface area (e.g., a return electrode that may have a surface area up to about 5000 times that of the tip delivery section). This may provide a non-uniform return path to sufficiently distribute and / or spread the RF power, making it safe enough to prevent burns.

[0043] Referring now to FIG. 1D, in some alternative embodiments, the ESU 100 may include an applicator 130a including an electrode array 160a (e.g., an electrode array having a plurality of individually addressable electrodes 162a) with a drain pad 130e as a return path to distribute power uniformly over a large area. As in FIG. 1C, the surface area of ​​the return electrode 130e relative to the treatment electrode array 160a may be a surface area that helps ensure that the RF energy is sufficiently distributed to prevent undesired injury. However, unlike the return pad 130e shown in FIG. 1C, the return pad 130e in FIG. 1D has a surface area that is comparable to the electrode array 130a, eliminating the benefit of the large surface area uniformity of the return pad 130e. That is, in general, making the surface area of ​​the return pad larger than the electrode array may help avoid undesirable side effects (e.g., hot spots, etc.) on the return pad. For electrode arrays such as that shown in FIG. 1D, where treatment is targeted over a large area, the size requirements for the return pad may be impractical and may not be sized to be compatible with non-treatment areas of the body (e.g., may be too large to be compatible with non-treatment areas of the body).

[0044] The teachings of the present invention also provide various mechanisms for reducing "hot spots" at the treatment active electrodes to ensure more uniform treatment, as described in more detail below. For example, as described in more detail below, distribution electronics in at least one applicator 130a may be used to provide the same or different RF signals to individual electrodes 162a in the electrode array 160a to improve control of the treatment process.

[0045] As shown in FIG. 1E, in some embodiments, the system 100 may instead use two electrode arrays on different applicators. These applicators consist of a first applicator 130a including a delivery treatment electrode array 160a and a second applicator 130b including a return electrode array 160b that may also function to deliver treatment energy from the electrode array. In such an embodiment, since the return electrode array 160b can mimic the treatment electrode array 160a and provide the same treatment energy, it may be possible to achieve good uniformity in the contact area of ​​the skin with both the first applicator 130a and the second applicator 130b. In some embodiments, both treatment pads have dimensions of about 100 cm. 2 1, each of which can deliver RF energy to provide deep, uniform heating. A third electrode can also drain power from a given site if there is differential heating of the two treatment sites in contact with the first and second applicators 130a, 130b, for example due to irrigation (as discussed above with respect to FIG. 1A).

[0046] In some exemplary embodiments, at least one applicator 130a-130d may optionally have at least one coupling structure (e.g., a clip, etc.) that allows the applicator to be clipped to a frame attached to a belt or the like that encircles the surface of the patient or that attaches the frame (and the applicator attached to the frame) to the surface of the patient via the belt or the like, allowing the clinician to couple the device to the patient without assistance. In other embodiments, at least one applicator 130a-130d may be attached directly to the surface of the skin, for example, by adhesive and / or gel and / or loose suction (reduced pressure), etc.

[0047] Although the applicators of FIGS. 1D and 1E are generally depicted as including a generally flat electrode array (e.g., a rigid or flexible electrode array, etc.), the applicators in some alternative embodiments may be configured for insertion into an internal tissue site to apply RF energy to the surface of mucosal tissue or to deliver the RF energy deeper below a mucosal surface (e.g., vaginal wall, mucosal lining, etc.). For example, as described in more detail below with reference to FIGS. 8-12, the applicators may include a generally cylindrical probe that may be sized and shaped to be inserted into the vagina or esophagus to perform RF treatment thereon. As will be appreciated by those skilled in the art from the description herein, the probe may have multiple electrodes (or groups of electrodes) that may be energized to apply RF energy to target tissue in a monopolar, bipolar, or hybrid fashion.

[0048] [Method of operation] The teachings herein include various electrical configurations, such as monopolar, bipolar, and hybrid configurations. A monopolar configuration includes an active electrode (or active electrode array) and a non-active electrode (e.g., drain pad, etc.). A bipolar configuration includes two separate active electrodes (or two separate active electrode arrays). A hybrid configuration includes two separate active electrodes (or two separate active electrode arrays) and a non-active electrode (e.g., drain pad, etc.). The exemplary electrical configurations shown in Figures 1C and 1D are monopolar configurations, and the electrical configuration shown in Figure 1E is a bipolar configuration. The electrode configuration shown in Figure 1A is a hybrid configuration. It will be understood that if only the pulsed handpiece 130d and the drain pad 130e in Figure 1 are used, such a configuration would be a monopolar configuration. On the other hand, if only the electrodes of the electrode arrays in the two applicators 130a, 130b are used to energize, a bipolar configuration would be used. Yet another option of using two applicators 130a, 130b and a drain pad 130e, among those shown in FIG. 1A, is a hybrid configuration.

[0049] Those skilled in the art will appreciate from the teachings of the present invention that an exemplary system may provide the following advantages and / or include some or all of the following features:

[0050] [Procedure temperature and patient skin cooling] In various embodiments, it may be important to ensure uniformity of delivered RF energy to safely elevate the target tissue to the desired temperature. Specifically, effective treatment may require not only elevating the target tissue to the desired temperature range, but also maintaining the tissue in the target area at the elevated target temperature for a given time. That is, "time at temperature" may be important to achieve the desired clinical effect. For example, temperatures may range from about 39°C to about 47°C, about 39°C to about 44°C, or about 42°C to about 47°C in the fat layer, with about 41°C to about 42°C being typical tissue temperatures used to treat tissue in the fat layer or other similar tissues at depth. In some embodiments, a temperature range of about 41°C to about 42°C may be used to preferentially stimulate collagen development. Higher temperatures up to about 46-47°C may be used to target more damaged tissue, allowing more aggressive treatment, such as to deeper tissue layers. However, the 46-47°C range may not be tolerated directly at the skin surface as the patient may find this relatively high temperature uncomfortable. In some aspects, elevated temperatures up to about 70°C or from about 40°C to about 60°C may be tolerated for submucosal tissue treatment temperatures. Treatment times at temperatures may range from about 5 minutes to about 25 minutes, but may vary depending on, for example, the depth, volume, etc. of the target tissue. As such, as discussed elsewhere herein, it may be important to actively control the RF energy to be distributed substantially homogeneously, substantially uniformly, predictably, and automatically (without user intervention) in the target tissue at the target treatment zone. In some embodiments, tissue surface temperatures (e.g., the skin surface and / or mucosal tissue surface, etc.) may be controlled to be maintained in the range of about 15°C to about 40°C or about 25°C to about 40°C during treatment of deeper tissues. By controlling the temperature at the surface of the skin to a range of about 15°C to about 40°C or about 25°C to about 40°C, a higher temperature range deeper (e.g., about 46-47°C, etc.) can be tolerated and achieved during treatment.

[0051] Cooling the surface of the patient's skin can both protect the epidermis and improve patient comfort. Sufficient surface cooling (e.g., cold water at a temperature of about 10° C. to about 40° C., or at a temperature of about 25° C. to about 40° C. or about 25° C. to about 35° C., etc.) allows higher RF powers to be applied safely and without sacrificing comfort than would be possible in the absence of such cooling. This can be important because most target tissues are located some depth below the surface, and surface cooling can protect intervening non-target tissue layers.

[0052] As described below, the electrode array may take a variety of configurations. In some exemplary embodiments, the electrode array may be attached (e.g., bonded or adhered) to an applicator that includes a metallic coolant housing. In various embodiments of the present teachings, an electrically insulating and thermally conductive layer (such as a ceramic, e.g., Kapton, AlO2, etc.) may be provided between the cooling housing (e.g., a cooling housing that includes a reservoir or receptacle for temperature-controlled cold water) and the electrode array so that the cold water cools the electrode array and the surface of the patient's skin. As previously described, the cold water may be circulated from the console 110 of FIGS. 1A and 1B through at least one fluid conduit (e.g., through at least one umbilical 133 to each of the applicators coupled to the at least one umbilical 133) by at least one pump, and a chiller / heater 138 may be configured to detect and / or appropriately maintain the temperature of the cold water.

[0053] [RF pulse length, taking into account the target tissue chosen for treatment] Various embodiments of the present teachings may provide a variety of treatment regimens. In various embodiments, long pulse lengths (e.g., greater than 1 second, CW, etc.), low power (e.g., approximately 1 W / cm 2 ~about 5W / cm 2 RF energy regimens with short pulse lengths (e.g., less than 500 ms, less than 100 ms, etc.), high energy (e.g., energy per pulse of about 10 to about 1000 J / cm2 , 10 J / cm 2 ~500 J / cm 2 , 10 J / cm 2 ~300 J / cm 2 , 10 J / cm 2 ~100 J / cm 2 RF pulse regimes of different types (e.g., septum, septum, etc.) are envisioned and may have different effects depending on the biological target selection and biological subject treatment. Without being bound by any particular theory, the method of action may be thermal in nature, with selected tissues being primarily or preferentially heated (and in some cases coagulated) by the delivered RF power. Thermal diffusion or conduction to nearby tissues is also envisioned as a treatment regime. Strictly speaking, different tissues have different electrical impedances, and RF energy tends to propagate through the anatomical structures or tissues with the lowest impedance. Thus, the preferential path of the RF may be a relatively low impedance path, such as connective tissue (e.g., fibrous septum tissue penetrating between fat layers). Thus, heat tends to accumulate in this RF conduction path, which has a relatively low impedance. For example, the connective fibers of the septum tissue begin to heat up before neighboring tissues. As the low impedance tissue accumulates heat (e.g., exhibits an increase in temperature), heat also begins to be conducted from the low impedance tissue to nearby tissues, such as fat, which have a relatively high electrical impedance compared to the connective fibers (e.g., septum tissue). Thus, as can be appreciated from the teachings of the present invention, the pulse length of the applied RF can be a method for selecting anatomical target tissue, as will be described in more detail below.

[0054] While short-pulse, high-power RF pulses can act to heat (and potentially coagulate) low-impedance tissues (e.g., connective fibers of septal tissues), long-pulse, low-power RF energy tends to heat low-impedance tissues slowly enough that heat is conducted to nearby tissues with high electrical impedance (e.g., fat). For example, when RF energy is applied in short-pulse, high-power pulses, fibrous structures heat up too quickly to conduct heat away to nearby high-resistance tissues (e.g., fat) fast enough to dissipate the rapid buildup of heat in the fibrous tissue. Thus, short-pulse, high-amplitude RF power can accumulate a temperature rise in tissues with low electrical impedance within the treatment area (under the applicator). Short-pulse (e.g., about 10 ms to about 500 ms, preferably less than 100 ms) and high-amplitude RF pulse energy (e.g., about 10 to 1000 J / cm 2) can be used to selectively treat low impedance tissues such as septa and other fibrous structures within a patient's tissue. Such short-pulse-length RF treatment pulses delivered quickly result in a temperature rise preferentially accumulating in fibrous connective tissue structures such as septa, as the overwhelming majority of current flows through fibrous structures located, for example, in high resistance, high impedance fat layers. The short-pulse-length RF pulses prevent the rapidly heated fibrous structures from conducting away heat to nearby high resistance tissues (e.g., fat, etc.) quickly enough to counteract the rapid build-up of temperature rise in the fibrous tissue. Thus, this effect of pulse length can "select" fibrous tissue or septa for treatment through the build-up of temperature rise while the surrounding tissue remains relatively cool. This technique can be useful for selectively heating fibrous structures such as septa (the primary cause of the cottage cheese or dimpled appearance of cellulite). This approach can be useful for coagulating fibrous structures such as septa within tissue. Although the example of the septum and surrounding fat is used, this ability to target or "select" tissues with large electrical impedance differences can be applied to a variety of other tissue types and tissue layers.

[0055] On the other hand, low power RF energy with relatively long pulse lengths may be desirable for (more or less uniform) heating of tissue layers exhibiting multiple and varying electrical impedances. That is, long pulse lengths (and for that matter, CW (continuous RF radiation)) may be used to treat all tissue types within the treatment area by heating low impedance connective / fibrous tissue or septa slowly enough to allow heat to be transferred by thermal diffusion and / or thermal conduction to the surrounding relatively high impedance tissues. This results in more or less general heating of all tissues within the treatment area (e.g., under the electrode array applicator). Thus, long pulse lengths or CW radiation (from about 1 second to continuous (CW)) and relatively low amplitude RF power (e.g., from about 1 to about 5 W / cm2) may be used to treat all tissue types within the treatment area. 2) can be used to treat tissue in a given block or zone homogeneously, regardless of the tissue components in that zone and the various electrical impedances of those tissue components. Long pulse length, low amplitude RF power tends to induce a temperature rise by thermal conduction in all tissues in the target area, regardless of electrical impedance. Fat cells have a lower damage tolerance (high temperature resistance) than connective fibers. Thus, the fat cells can be lysed while leaving the connective tissues largely intact. Thus, the teachings of the present invention provide a method to effect lipolysis, for example, by heating the connective fibers (septa) with low amplitude, long pulse length (or CW), thereby heating the neighboring fat cells. As can also be appreciated from the teachings of the present invention, the pulse length can be fine-tuned to optimize temperature deposition in the desired target tissue while protecting the surrounding tissues from exposure to excessive temperature rise.

[0056] [Electrode array] In various aspects, a large electrode surface (e.g., an electrode pad, etc.) may be segmented into numerous smaller electrodes (e.g., an array of multiple individual electrodes, etc.). The electrode array may have a variety of configurations, but is generally configured such that the multiple electrodes constituting the array are placed in electrical contact with tissue to allow RF energy to be applied to the tissue. The individual electrodes constituting the electrode array may be of various numbers and shapes, sizes, and layouts (e.g., pitch, etc.). Suitable electrodes may have individual diameters ranging from about 3 mm to about 100 mm, about 10 mm to about 70 mm, about 10 mm to about 30 mm, etc., but are not limited to these examples. In one embodiment, for example, the individual electrodes in a given electrode array may each have a diameter of about 1 cm. In some aspects, a group of electrodes in a given electrode array or multiple electrode arrays may be arranged in a given pattern, and the given pattern may be approximately 1 cm. 2 ~about 500 cm 2At least one of the electrode arrays may form a shape, such as a hexagon, rectangle, circle, oval, diamond, trapezoid, or other shape suitable for targeting a particular tissue region for treatment. The number of individual electrodes within an electrode array may also vary. In some aspects, for example, there may be about 2 to about 100 electrodes within an electrode array. In other embodiments, there may be about 6 to about 20 electrodes within an electrode array. In one non-limiting example, 19 electrodes are positioned over an area of ​​about 20 cm. 2 The electrodes are arranged in a hexagonal pattern to occupy a surface area of ​​100 mm. By providing multiple applicators or multiple groups of electrodes (e.g., multiple electrode arrays, etc.) to occupy a desired surface area of ​​tissue, large areas of tissue may be treated.

[0057] [Individually switchable electrode array] As can be appreciated from the teachings of the present invention, by segmenting a large electrode surface into multiple smaller electrodes, each electrode in the array can be individually addressable and energized, thereby achieving a substantially uniform delivery of energy. To achieve a uniform delivery of energy, at least one individual electrode in the array can be individually addressable and energized based on tissue feedback, including, for example, temperature and / or impedance feedback, as described in more detail below. In some embodiments, for example, only one electrode (or only a portion of the electrode array) can be energized based on the tissue feedback to assist in substantially uniform heating of the tissue. In other embodiments, individual control of the electrodes can help ensure or control maintaining a heating zone centered within the desired treatment zone location (e.g., beneath the electrode array applicator) and / or maintaining a substantially uniform and consistent temperature rise within the desired treatment area, regardless of variations in electrical impedance of tissue beneath the patient's surface or nearby anatomical structures.

[0058] 1A and 1B , the distribution electronics of at least one applicator 130a-130d of the system 100 may be used to provide the same or different RF signals to individual electrodes in at least one electrode array 160, adjusting one or more of, for example, power and / or RF frequency and / or pulse width and / or duty cycle, to improve control of the treatment process. In such an embodiment, each individual electrode in the electrode array in contact with the patient may be addressed (e.g., switched to conduct RF power or duty cycle applied to each electrode) independently of the other, and each individual "channel" may be able to provide current and / or voltage and / or phase angle feedback information useful for calculating the power and impedance of each individual electrode. In some aspects, the independently switchable electrodes in an array may be switched (e.g., by a controller 137, etc.) to conduct RF power simultaneously to each individual electrode in the array, or the independently switchable patient-contacting electrodes in an array may be switched (e.g., during impedance mapping, as described below, etc.) to conduct RF power sequentially, first to a given electrode in the array and then to another electrode in the array, until all or nearly all of the electrodes in the array have been addressed.

[0059] In some embodiments, an array of individually controllable RF electrodes may be used to disrupt connective tissue that penetrates between fat layers (e.g., fibrous septum tissue present in cellulite during septum disruption). In an exemplary such embodiment, the electrode array is positioned over the tissue region to be treated, and an electrode (or a portion of electrodes) in the array of electrodes is individually addressed to deliver short pulse length (e.g., less than 100 milliseconds), high energy (e.g., about 10 to about 1000 J / cm). 2The septum underlying the electrode array may be targeted for treatment by applying at least one pulse of a short pulse or series of pulses from a first electrode (or a subset of electrodes). After a short pulse or series of pulses from a first electrode (or subset of electrodes), another electrode (or subset of electrodes) in the array may be addressed to apply a short pulse or series of pulses. This process may be repeated until multiple or all electrodes in the array have been addressed to apply short pulse length, high power RF pulses such that the entire tissue area underlying the array is targeted. In some cases, individual electrodes are sequentially addressed to apply short pulse length, high power RF energy. In one embodiment, the septum tissue, which has a relatively low impedance, is preferentially heated by relatively short pulses obtained by conducting all or nearly all of the RF energy available across the electrode array to individual electrodes. In an alternative embodiment, a more powerful power source may be used to provide the desired and / or required high amplitude energy (e.g., about 10 to about 1000 J / cm2). 2 etc.) to individual electrodes, thereby preferentially targeting septum tissue.

[0060] In other embodiments, an array of individually controllable RF electrodes may be used to disrupt connective tissue that penetrates between fat layers, as well as to perform loosening and relaxation (and / or lipolysis) procedures. For example, an RF electrode array may first be used to disrupt (e.g., rupture, etc.) septa in the tissue region underlying the array using relatively short pulse lengths and high amplitude power as described above. That is, after each short pulse by one electrode (or a subset of electrodes), another electrode or subset of electrodes in the same array may be addressed to apply a short pulse, and the process may be repeated until all of the tissue region underlying the array has been targeted. The same electrode array may then be used to deliver relatively long pulse lengths and low power (e.g., about 1 to about 5 W / cm2) to the tissue region underlying the array. 2For example, the septum tissue may be targeted with a short pulse length, high power RF treatment, and then the same tissue region may be treated with an RF electrode array for loosening or relaxation by simultaneously addressing all or nearly all of the electrodes to apply a relatively long pulse or series of long pulses (e.g., from about 1 second to continuous (CW)) for an exposure time in the range of 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. Also, in some embodiments, a tissue region may be thermally treated first with a long pulse from several and / or all of the RF electrodes in the array, followed by treatment of the targeted septum by sequentially applying shorter pulses to each (or in some cases, a few) of the electrodes in the array of electrodes.

[0061] [Flexible electrode array] Various aspects of the present teachings contemplate flexible electrode arrays that allow for improved coupling to curved surfaces and contours of a patient's body. In such aspects, the applicator array may include multiple electrodes (e.g., individually controllable electrodes, etc.), and the individual electrode units may each be approximately 1 cm long. 2 and may have a thin metallic surface integrated into a flexible substrate. In some aspects, the individual electrodes may be flexible (e.g., bendable) due to the thin thickness of the conductive material (e.g., metal, etc.) of the electrodes. Alternatively, the electrodes may comprise, for example, a metallic (e.g., copper) woven fabric that is itself flexible to conform to the contours of the tissue surface. Thus, the electrodes may consist of a matrix of rigid or flexible electrode units mounted on a flexible substrate, the matrix being proportional to the area (cm) of the applicator. 2) by one to three orders of magnitude. This flexibility allows uniformity of treatment to be achieved at both large and small scales. Custom shaped array patterns are also contemplated and any shape suitable for a given treatment may be used, for example boomerang, rectangular or trapezoidal shapes may be useful for chin or chin treatment. Various variations in shape and size are possible as can be appreciated from the teachings of the present invention.

[0062] [Disposable applicator] In some embodiments, the applicator (e.g., applicator 130a in FIG. 1A) or a portion of the applicator may be provided as disposable. For example, a skin-contacting portion of the applicator including the treatment electrodes and a portion of the cooling conduit may be configured to couple to a non-disposable umbilical portion (connecting the applicator to the console) including relatively expensive distribution electronics. The umbilical portion may be removably coupled (e.g., with pins, etc.) to electrodes in the disposable portion of the applicator. The umbilical portion may further include at least one fluid conduit that provides fluid to the disposable portion of the applicator (e.g., via at least one fluid coupling element, etc.). In various embodiments, an adhesive gel may be applied to a surface of the applicator and covered by a protective sheet. The sheet may be removed (e.g., peeled off) and the applicator may be placed on the skin. Optionally, an adhesive gel pad may be discarded after one or more treatments, while the remainder of the applicator may be reusable. Alternatively, in some aspects, the entire applicator may be disposable. In such aspects, the cost of the disposable applicator may be reduced by moving relatively expensive fittings and circuitry to the umbilical portion.

[0063] Reference is now made to FIG. 2, which shows a schematic representation of a portion of another exemplary system for RF treatment according to the above and other aspects of the teachings of the present invention. In FIG. 2, a cross-section of skin including dermis, subcutaneous (mostly fat) and muscle layers is depicted with an exemplary RF applicator 230 in intimate contact with the surface of the skin. As described elsewhere herein, coolant from the console (such as the console 110 of FIGS. 1A and 1B including temperature controlled water circulation means 138) may flow through cooling lines in an umbilical 233 to maintain the surface temperature of the skin while RF energy is applied to an array 260 of electrodes 262 to heat the skin. This ratio of cooling to heating may be used to regulate not only the surface temperature of the skin, but also the distribution of heat in the skin, thereby allowing selection of a target treatment zone (e.g., treatment depth, etc.). In general, decreasing cooling while keeping the RF power the same will tend to move the heating zone towards the skin surface (e.g., to heat the dermis to tighten or thicken the skin, etc.). Increasing cooling will tend to push the heating zone down into lower tissue layers. As will be described below, the combination of short pulse length RF energy and cooling will tend to preferentially heat tissues with the lowest impedance (e.g., septa, etc.) while protecting the skin (e.g., preventing tissue from heating overall). In this way, the distribution of thermal energy within the skin can be adjusted by adjusting the surface temperature of the skin.

[0064] Also, the disposable applicator 230 in various embodiments can be flexible as described above and can include a tacky adhesive on the patient-facing side of the electrodes to provide a flexible pad that adheres to the patient's surface. In certain embodiments, contact with the patient's skin surface can be made by an adhesive gel. Although in some embodiments the gel layer can be thermally conductive to allow for cooling of the skin, the gel layer does not need to be electrically conductive since most of the power coupling can be capacitive due to the use of high RF frequencies. As shown in FIG. 2, 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 to which the RF signal is applied and the tissue surface. Additionally, a receptacle 264 can be provided through which hot water or cold water can flow. This allows a fluid passageway to be formed when the disposable portion (i.e., the portion below the dashed line) and the umbilical portion of the applicator are coupled. As will be described, the receiving portion 264 can be flexible, allowing the entire applicator 230 to conform to the contours of the tissue surface during application (e.g., when fitted). Additionally, the electrodes 262 are distributed throughout the applicator 230, and in some embodiments, each of the electrodes 262 can be individually addressable, such as via leads that can be electrically connected to pins on the distribution electronics on the umbilical portion of the applicator 230. In certain embodiments, it may be desirable to cool the electrodes and the area surrounding the electrodes. However, in some applications, cooling only a portion of the applicator area may be effective enough. As shown, different amounts of energy can be applied to different electrodes depending on the impedance beneath them. More energy is applied to areas with thicker fat and higher impedance.The exemplary connector concept shown in FIG. 2 is merely a non-limiting depiction of at least one disposable concept in which the expensive components used for precise distribution of RF and monitoring electronics are placed on the reuse side, with the multi-wire array connector and water lines (including relatively inexpensive flexible electrodes) formed as the disposable part.

[0065] As previously mentioned, the flexible electrodes can be supplied with cold water through an electrically insulating layer to the back side of the electrodes (the side not connected to the patient) to control the surface temperature of the patient's skin during treatment. For example, FIG. 3 illustrates an exemplary flexible cooling receptacle layer 364 for a flexible applicator configured to bend over compound curves such as the chin, flank, etc. Thus, a multi-layer adhesive pad structure can include electrodes embedded in an adhesive laminate of thin-plated copper foil or fine-plated copper fabric (e.g., fabric die-cut to a given shape, etc.). A flexible cold water manifold 364 as shown in FIG. 3 can constitute the top layer of the disposable pad. The manifold can be made of two layers of polymeric sheet (e.g., two layers of polymeric sheet die-cut and heat-bonded to a labyrinth pattern at various locations 366, etc.) to form at least one fluid flow path 365 between the two layers. In various embodiments, the electrodes may be cooled directly with water without conduction through the flexible substrate. Electrode layers that may be used with the flexible cooling receptacle layer of Figure 3 may include any of the electrode arrays described elsewhere herein, including the rigid or flexible electrode arrays described above with reference to the systems of Figures 1A-1E, 2, etc.

[0066] [Electrode dimensions and pitch] The electrode dimensions and pitch can be designed to minimize electrical complexity while maintaining flexibility, while still achieving the desired uniformity of RF delivery. The rigid portion of the electrode area is approximately 1 cm 2Some electrodes may be flexible enough to safely couple RF power to the skin (e.g., eliminate over-bundling) while still providing sufficient area between adjacent electrodes to conform to most anatomical structures. If the electrodes themselves are flexible, such as woven copper fabric, the size constraints of the electrodes may be determined by edge effects (concentration of RF power at the edges of the electrodes causing non-uniform application of RF and resulting non-uniform heating). By achieving a compromise between edge effects and thermal properties of tissue, the electrode area may be optimized to provide substantially uniform heating of the skin and underlying tissue. The pitch or distance between adjacent electrodes in a given array may also be optimized to heat the target area for the duration of the treatment. A suitable pitch between adjacent electrodes may be in the range of about 0.1 mm to about 2 cm (e.g., about 1 mm to about 1 cm, etc.). For resistively coupled electrodes, a suitable electrode diameter may be in the range of about 3 mm to about 20 mm or about 10 mm. For capacitively coupled electrodes, suitable electrode diameter dimensions may be in the range of about 3 mm to about 200 mm, or may be about 10 mm.

[0067] For example, in the case of a partial ablation RF procedure described later, the dimensions and pitch of the electrode array can be relatively small, in the range of about 0.1 mm to about 10 mm or about 0.5 mm to about 5 mm, and the closely spaced electrodes can occupy almost the entire applicator area. This is because in the case of a partial ablation RF procedure, the pulses are short (e.g., about 100 ms, about 5 ms to about 35 ms, etc.) so that there is no time for thermal diffusion to occur between the specific tissues targeted by each electrode, and the tissue can be ablated by such short pulses of relatively high energy.

[0068] For tissue heating and loosening treatment applications, the thermal properties of the skin / fat will determine the heat distribution and the exposure will be long (e.g., 10-30 minutes), which may allow the use of larger electrodes and longer pitches to achieve overall heating of the tissue.

[0069] In the case of septal rupture, a single electrode or a single electrode array can be used where a short pulse length, high power RF pulse is delivered to the target tissue and can be hands free after placing the electrode in the tissue as described herein, or the single electrode or the single electrode array can be constructed as a hand piece to be used in a stamping fashion to account for the short pulses associated with septal rupture.

[0070] [Cluster of electrodes] In some embodiments, clusters of electrodes (i.e., nodes in an array that include multiple electrodes sharing a common electrical control) can be used to reduce electrical complexity while enjoying the benefits of using small electrodes for uniformity, flexibility, and reduced edge effects. In the simplest case, instead of driving each individual electrode in an electrode array, similar control (e.g., equivalent RF signals, etc.) can be used for multiple clusters of two, three, four or more electrodes (and it is unlikely that more detailed control is required to obtain resolution of thermal effects) (although it may be preferable to keep the number of electrodes large). Electrode cluster configurations can be used to treat connective tissue that penetrates between fat layers (e.g., fibrous septa present in cellulite, etc.) by, for example, applying a short pulse length, high power RF pulse to a given electrode cluster, followed by a short pulse length, high power RF pulse to another electrode cluster in the same electrode array until all or nearly all electrode clusters in the array have been addressed. In one embodiment, all or nearly all of the RF energy available across the electrode array is conducted to each individual electrode cluster, resulting in relatively short pulses that preferentially heat the septum tissue, which has a relatively low impedance. In an alternative embodiment, a more powerful power source may be used that is capable of delivering the desired and / or required high amplitude energy per pulse (e.g., about 10 to about 1000 J / cm2). 2etc.) to each individual electrode cluster, thereby preferentially targeting the septum tissue. As described in more detail below, by monitoring and / or knowing the impedance of each electrode (or most or nearly all of the electrodes) in real time, the contact integrity of each electrode (or most or nearly all of the electrodes) to the tissue can be determined, thereby preventing inadvertent over-treatment of an area smaller than the target region (e.g., avoiding burns).

[0071] [Patient impedance mapping] Various embodiments of the present teachings contemplate various sensing and / or feedback mechanisms to aid in improving RF treatment. Uniformity of RF treatment may be promoted by using tissue impedance mapping alone or in combination with surface margin temperature feedback, as described below. In some embodiments, the patient's tissue impedance may be "mapped" by detecting the impedance of the tissue region to be treated (or being treated). Impedance differences may then be compensated for, for example, by controlling or modifying the distribution of RF power (or total treatment time or duty cycle) delivered from each individual electrode in the electrode array based on information gathered from impedance mapping and / or surface margin temperature feedback. Such impedance mapping may adjust and / or prevent heat buildup in non-targeted regions (e.g., outside the applicator margin). Such impedance mapping may adjust and / or prevent non-uniformity of the treatment zone (whether due to anatomical differences or due to variations in the thickness of the tissue layer) and / or unexpected non-uniformity of RF application.

[0072] In certain embodiments, the electrical impedance of each electrode in the electrode array may be mapped by polling the electrodes in the electrode array against the tissue surface of the patient to measure the individual impedance of the tissue between each pair of electrodes in the pair of applicators, i.e., the corresponding tissue impedance below each electrode. For example, the mapping process may be performed with the exemplary two electrode arrays in contact with the tissue surface (or different tissue surfaces) using very low RF power (e.g., a secondary treatment power that does not substantially increase the temperature of the tissue). The impedance may then be detected for all combinations of a given electrode from one array with a given electrode from the other array, e.g., by selectively energizing the individual electrodes. After the tissue impedance for a combination is measured, the electrodes may be de-energized. The other electrodes may then be "poled" until each of the individual electrodes in the two arrays (e.g., the left array and the right array) have been addressed to measure the impedance along this particular path and other paths. Optionally, the repetition of this process may end when all of the individual electrodes in one array have been addressed. In this way, the tissue impedance of the tissue underneath all of the electrodes in the array is measured. The repetition of this process may be performed at different RF frequencies, and may be performed just before application of the treatment RF power or at different times during the treatment. For example, this first step of impedance mapping may be performed in less than one minute (e.g., about 30 seconds). Based on these measurements, as can be understood from the teachings herein, the relative thickness of the subcutaneous fat layer may be calculated, such as by the impedance difference between fat and muscle. A map of the patient's impedance underneath each individual electrode provides a corresponding map of tissue impedance across the treatment zone.This allows distribution electronics in at least one applicator 130a to be used to provide the same or different RF signals to individual electrodes 162a in the electrode array 160a as described above in connection with Figures 1A-1E for improved control of the treatment process. In some related embodiments, the distribution electronics can be further controlled to independently switch each electrode in the electrode array (e.g., to conduct RF power to each electrode), and each individual channel can provide current and / or voltage and / or phase angle feedback information useful for calculating the power and impedance of each electrode. In an exemplary impedance mapping process described below with reference to Figure 4, for example, independently switchable contact electrodes in the electrode array can be switched to sequentially conduct RF power first to a given electrode in the array and then to another electrode in the array until all or nearly all electrodes in the array have been addressed to map tissue. It should be noted that although FIG. 4 depicts the impedance mapping process between two electrodes on two different applicators, one skilled in the art will appreciate that such description is equally applicable to any number of applicators and electrode arrays.

[0073] As shown generally in Fig. 4, two applicators 430a, 430b, each including an array 460 of 16 electrodes 462, may be placed against a tissue surface. With the applicators coupled to the tissue surface at the intended treatment site, and prior to applying treatment RF energy (i.e., energy of sufficient power to perform treatment at the target tissue), an impedance mapping process may be performed to measure the impedance (tissue resistance to RF energy) for every combination of an electrode 462 from applicator 430a and an electrode 462 from applicator 430b. For example, the electrodes 462 of the two applicators may be selectively energized to drive a very low RF current (e.g., secondary treatment energy, etc.) from A1 to B1, A1 to B2, A1 to B3, etc., until a 16x16 matrix of resistance values ​​is generated to determine the tissue resistance between all electrodes in applicator 430a and all electrodes in applicator 430b. It has been found that, in general, the impedance between adjacent edges of applicators 430a, 430b is lowest when applicators 430a, 430b are placed in tissue in close proximity to one another (e.g., rather than spaced apart or on opposing tissue surfaces) as shown. That is, the resistance between A4 and B1, A8 and B5, A12 and A9, and A16 and B13 tend to be the lowest impedance (depending on tissue type, as discussed elsewhere herein). This means that the greatest RF current and heating will occur along these low impedance paths during treatment.

[0074] The impedance topography revealed by this technique can thus identify variations in electrical impedance of the patient's tissue, which can be used to redistribute or adjust the RF power and / or treatment time delivered to each individual electrode to improve uniformity of heat (temperature rise) application for more effective fat destruction, dermis tightening, collagen heating, or septum targeting, or to maintain a treatment zone centered under the applicator (e.g., electrode array, etc.) for more uniform tissue temperature. For example, electrodes that detect an impedance lower than the median impedance of all electrodes tend to apply more RF energy (resulting in a relatively higher temperature rise) than electrodes that detect a higher impedance. Thus, to homogenize a treatment zone and ensure uniformity and centering within the treatment zone, the impedance topography map can be used to select electrodes at low impedance locations to reduce RF power and / or select electrodes at high impedance locations to increase RF power. Such an increase or decrease in RF power delivered from an individual electrode may be proportional to the difference in electrode impedance relative to the average electrode power. Thus, in a given embodiment, the distribution electronics of at least one of the applicators may be used to adjust the RF signal to each individual electrode in the electrode array to account for that difference in impedance. For example, independently switchable contact electrodes 462 in arrays 460a, 460b may be switched (e.g., under the influence of controller 137 of FIGS. 1A-1E) to adjust the RF power delivered to each individual electrode 462 to assist in the uniform application of thermal energy within the treatment region.

[0075] Referring again to FIG. 4, data collected during the impedance mapping process may also be used to adjust the electrode energization pattern (e.g., RF power, pulse width, total treatment time, duty cycle, etc.) to help maintain uniform heating under the applicators 460a, 460b. For example, one possible approach to reduce edge effects between electrodes at adjacent edges is to alternate energizing electrodes A{1,2,5,6,9,10,13,14} and electrodes B{1,2,5,6,9,10,13,14} (while deenergizing the other electrodes) during a first period and energizing electrodes A{3,4,7,8,11,12,15,16} and electrodes B{3,4,7,8,11,12,15,16} during a second period to promote more even spacing and more uniform heating. Alternatively, the RF power of electrode A {4,8,12,16} and / or electrode B {1,5,9,13} may be significantly reduced and / or permanently disabled, for example, during the treatment time. Then, the area under the turned off electrode will also be heated, since the next adjacent row between the applicators, i.e., electrode A {3,7,11,15} and electrode B {2,6,10,14}, show a slight tendency to feed current to each other laterally. Such a pattern (e.g., generated by the distribution electronics under the influence of a controller) can make the heating more uniform, for example, under two adjacent electrodes operating in a bipolar manner.

[0076] During treatment, impedance monitoring (e.g., sampling, etc.) may also be performed in parallel to track changes in tissue impedance, and the power to each array location may be adjusted accordingly based on such feedback to track and control the RF power applied to each electrode 462 and / or to determine the treatment endpoint. For example, during treatment, the distribution electronics may be controlled to sample each of the electrodes 462 in the electrode arrays 460a, 460b (e.g., by conducting RF power to each electrode), with each individual "channel" providing current and / or voltage and / or phase angle feedback information useful for calculating the power and impedance of each electrode. That is, this impedance mapping may be performed in real time during treatment (e.g., at given time intervals during the treatment). Ideally, this control feedback mechanism may inform the power homogenization algorithm to monitor and / or adjust treatment conditions. Such impedance mapping may be particularly useful during the early stages of treatment, e.g., until a temperature change (detectable by temperature detection means, described in more detail below) accumulates at the tissue surface adjacent the target treatment zone. Later in the treatment, when an increase in surface temperature is observable, the impedance mapping feedback may optionally be summed with feedback from temperature detection at the tissue surface (e.g., around the applicator periphery) to provide additional feedback information. Summing these two feedback mechanisms together (e.g., taking 50% of the RF correction factor from the impedance topography map and 50% from the RF correction factor suggested by observing the surface temperature) is merely one non-limiting, exemplary approach. Other feedback approaches, such as, but not limited to, transitioning to the use of surface temperature feedback techniques when a detectable change in surface temperature occurs (e.g., 1 / 2-1°C or more).Additionally, in various embodiments of the teachings of the present invention, impedance mapping alone can be used to redistribute the RF power applied from each electrode to achieve optimal treatment placement, optimal homogeneity, or a desired uniformity, or to obtain temperature information about the target tissue (e.g., tissue beneath the surface of the skin or mucosa).

[0077] As previously discussed, short pulse lengths of relatively high amplitude RF energy may be used to "selectively target" tissues such as fibrous tissues, connective tissues, septa, and the like (as well as blood and lymphatic vessels), which are structures found in any tissue and exhibit relatively low electrical impedance compared to bulk tissue. In various aspects of the present teachings, during application of at least one such RF pulse, the measured impedance of the tissue region (including the septa) may be monitored and tracked to determine real-time changes in tissue composition. For example, during delivery of the RF pulse, the current, voltage, and their phase relationships may be monitored to calculate the impedance of the tissue to the RF energy being applied. See, below, FIGs. 5A-5F. Also, in various aspects of the present teachings, during treatment, impedance tracking of individual electrodes and / or the average impedance between the electrodes in the array may be used to determine when treatment should be terminated. As previously discussed, certain tissue types (e.g., fibrous structures such as septa) generally exhibit lower impedance than, for example, adipose tissue. That is, in certain aspects of the teachings of the present invention, impedance can be monitored to determine when the application of RF energy has sufficiently altered these low impedance tissues to produce the desired results.

[0078] FIG. 5A is a plot of tissue impedance upon application of an exemplary RF signal 205 for applying a 500 millisecond pulse of high power RF energy beginning at time 210B shown at the top of the figure. For example, the impedance of untreated tissue as shown diagrammatically in FIG. 5B may be measured by applying a low sub-treatment threshold RF power between the active electrode and the drain pad (or another active electrode in a second applicator) prior to the start of the pulse at time 210B. As discussed elsewhere herein, it is understood that at such a relatively low impedance detected at time 210B, RF energy will propagate through the untreated septum 200 shown in FIG. 5B. However, as shown in FIGS. 5A and 5C, application of treatment RF energy subsequent to the start of the pulse at 210B may cause the tissue impedance to change during heating. It can generally be seen from impedance measurements that the impedance of the tissue between the active electrode and the drain pad (or another active electrode in a second applicator) decreases as the septum heats up and / or contracts (as represented diagrammatically by the reduced septum 210 length in FIG. 5C) primarily due to RF energy propagated to the septum 200 between the start of the pulse at 210B and time 210C (e.g., about 300 milliseconds). For example, in some embodiments, a small change in impedance during the RF energy pulse (e.g., the measured impedance changes by a discernible amount, such as about 3%, more than 3%, between about 3% and about 20%, or about 10%) may indicate that the septum has heated up and / or contracted and / or tightened. As heat continues to accumulate in the septum, the impedance suddenly spikes between times 210C and 210D shown in FIG. 5A. Without being bound to a particular theory, this dramatic increase in impedance may be due to a dramatic change in the structure and / or composition of the tissue between the active electrode and the drain pad (or another active electrode in a second applicator).With reference to FIG. 5D, for example, this increase in impedance may be due to the absence of low impedance pathways in the bulk tissue as a result of the RF energy causing rupture of the septum, increasing the detected impedance to a level consistent with that of the bulk tissue (including adipose tissue, which has a high impedance). For example, in some embodiments, a dramatic increase in impedance during the RF energy pulse (e.g., a sudden increase in measured impedance by a discernible amount, such as about 3%, more than 3%, about 3% to about 20%, about 10%, more than 10%, or more than 20%) after the initial decrease in impedance as described above may indicate that the septum has significantly increased in temperature, causing coagulation and / or denaturation and / or rupture and / or destruction of the septum. As shown in FIG. 5A, after time 210D (e.g., about 400 ms), the detected impedance remains at a relatively similar level, even though the exemplary RF pulse continues to be applied for the entire length of the RF pulse, 500 ms (time 210E). As can be seen from the teachings herein, by monitoring tissue impedance during treatment, it is possible to determine whether a desired result has been achieved, and in some embodiments, such changes may be used to determine an endpoint of application (end of treatment) and / or to adjust treatment parameters (e.g., increase power, increase pulse width, apply additional RF pulses, etc.). For example, if such a dramatic increase in impedance is observed, treatment may be terminated at time 210D (e.g., by ceasing the pulse or series of pulses, etc.).

[0079] In various embodiments, the sampling rate of the monitored impedance (e.g., as shown by the black dots in FIG. 5A) can be selected to obtain a desired fidelity of the results. For example, the monitoring sampling rate can be any number of sampling times or frequency during the pulse emission. For example, the monitoring sampling rate can occur about 5 times, about 10 times, about 100 times, or about 1000 times during the RF pulse emission.

[0080] The impedance tracking described above during RF treatment may be used with both pulsed single electrode applicators (such as applicator 130d of FIG. 1A) and applicators including multiple electrodes (such as applicator 130a of FIGS. 1A, 1B, 1D, and 1E). In various embodiments of applicators including arrays of individually addressable electrodes, after the impedance of the tissue between an electrode 562 (or a cluster of electrodes) in an array 560a on an applicator 530a as shown in FIG. 5E and an electrode 562 (or a cluster of electrodes) in an array 560b on a second applicator 530b has changed sufficiently, similar treatments may be performed on different regions of the tissue and septum under the same electrode array using different combinations of electrodes 562 between the two applicators (or between the applicator and the drain pad) as shown in FIG. 5F.

[0081] In various embodiments, the electrodes may also be monitored to determine whether at least one of the electrodes is in sufficient contact with the tissue by monitoring the electrical state of each electrode for an open circuit (non-contact) condition. In such embodiments, uniform application of the applicator and any drift in the electrical state of the applicator from the time of application (e.g., the start of treatment) to the completion of the process (e.g., loss of moisture in the gel adhesive) may be exploited to prevent misinterpretation of tissue impedance status. As the electrode array may be comprised of many individual electrodes, being able to continuously monitor the impedance at each array location may also automatically provide a robust method of monitoring the electrode array.

[0082] [Patient Surface Temperature Feedback: Patient surface marginal temperature feedback used for RF uniformity compensation] As previously mentioned, various aspects of the present teachings contemplate various sensing and / or feedback mechanisms to aid in improving RF treatment. For example, RF treatment uniformity may be promoted by using surface temperature feedback alone or in combination with impedance mapping, as previously described. For example, by detecting temperature changes at various locations of the tissue surface near the target area, it may be possible to control or modify the distribution of RF power (or total treatment time or duty cycle) delivered from each individual electrode in the electrode array to adjust and / or prevent heat buildup in non-target areas (e.g., outside the applicator edge) and non-uniformity of the treatment zone (whether non-uniformity due to anatomical differences or variations in tissue layer thickness).

[0083] In an exemplary embodiment, the surface temperature of the patient's skin in the area surrounding the periphery of the applicator electrode array may be monitored, for example and without limitation, by IR sensors, thermocouples, etc., to identify uneven heating of the skin surface area near the intended treatment zone. Based on these signals (either alone or in combination with impedance mapping), a control means (including a microprocessor and algorithms as in FIG. 1A) may provide correction factors to the RF power set points of the individual electrodes to optimize treatment uniformity, homogeneity, and placement of the treatment zone.

[0084] As previously mentioned, treatments for loosening or laxing skin, or other procedures requiring generalized heating, require that a "time at temperature" be maintained for a given tissue type, anatomical region, desired treatment endpoint, etc., including, but not limited to, examples. A suitable treatment temperature range may be about 42-47°C, and a suitable total treatment time may be within the range of about 10-35 minutes, including, but not limited to, examples. However, dosimetric techniques using a total energy vs. volume approach may not distinguish between wide variations in patient perfusion (e.g., cooling effect, etc.) and variations in thermal capacity of various tissue types (e.g., nearby bone and / or viscera and / or hot fat layers will all experience different temperature buildup when exposed to a given dose (J / volume).

[0085] Predictable RF uniformity is important for the efficacy and safety of applied RF treatments and can be critical in the case of non-uniform adipose layers. However, applying uniform RF energy (e.g., 1 MHz, etc.) through a patient's skin to deeper tissues (e.g., adipose layers) is complicated by different tissue types and impedance variations. For example, as previously discussed, fibrous structures and other connective tissues have a lower impedance to RF energy than adipose tissue. Moreover, tissue layers below the adipose layer, such as muscle and large blood vessels, also have a much lower impedance than fat. As a result, RF energy will preferentially travel along these low impedance paths rather than through adipose tissue, and will tend to preferentially heat these low impedance tissues (at least initially) before diffusing to nearby fat cells.

[0086] Specifically, when an RF treatment applicator is placed directly on a non-uniform fat layer relative to the tissue surface (e.g., one side of the applicator is placed on a 20 mm thick fat layer and the other side of the applicator is placed on a 40 mm thick fat layer), heat and / or treatment of non-target tissues may be unevenly distributed. That is, because fat cells have a higher impedance than deeper tissues, such as muscle tissue, even if RF energy is delivered uniformly to the surface, the RF energy will "swerve" toward the lowest impedance (in this case, toward muscle). Since RF energy generally travels through the shortest path length in the high impedance fat layer to the deeper tissues, the RF energy will tend to be delivered through the 20 mm thick fat layer. This will increase the temperature on this side of the applicator compared to the 40 mm thick fat side of the applicator. This causes the "treatment zone" (the area of ​​tissue that experiences an increase in temperature) to deviate toward the shallowest fat layer, causing the actual treatment zone to shift from underneath the applicator toward the shallowest fat layer (an undesirable effect that is somewhat difficult to predict).

[0087] The effects of such non-uniform energy distribution, and various advantages of various aspects of the teachings of the present invention, can be better understood with reference to Figures 6A-6E. First, reference is made to Figure 6A, which shows the temperature profile of a relatively uniform 40 mm thick layer of fat during treatment with the same RF power delivered by each of multiple electrodes. In Figure 6A, the left vertical axis is distance (m) from the surface of the patient's skin (e.g., depth below the surface of the skin) and the horizontal axis is distance (m) from the center of the applicator. The right vertical axis is temperature (°C). As shown, the temperature is uniformly distributed within the treatment zone, which is symmetrical and located directly beneath the RF energy applicator.

[0088] On the other hand, FIG. 6B shows a non-uniform fat layer temperature profile during the same RF treatment as FIG. 6A. Specifically, in FIG. 6B, a fat layer of about 40 mm thickness is present on the left side, while a fat layer of about 20 mm thickness is present on the right side. This may be an undesirable result because the temperature of the treatment zone is asymmetric and deviates away from the thicker fat layer, which is not directly under the RF energy applicator (moving toward the thinner fat layer on the right side of FIG. 6B). FIG. 6C shows a schematic of this deviation of the treatment zone. The vertical axis represents depth, and the horizontal axis represents the distance (m) from the center of the applicator parallel to the surface of the skin. As shown, the zone of target treatment temperature is asymmetric and moves away from the center of the applicator.

[0089] FIG. 6D shows an exemplary temperature profile of the tissue surface based on the simulation of FIG. 6B and FIG. 6C. The left vertical axis is temperature (° C.) and the horizontal axis is distance (m) (along the skin surface) from the center of the applicator. As shown in FIG. 6D, two hotter lobes are observed, corresponding to the two sides of the circumference of the cooling surface of the applicator. In the case of a uniform fat layer thickness, these two lobes would be expected to be of similar size to each other. However, in the illustrated case, the lobes are asymmetrical due to the shallow fat layer that has caused more RF energy to be deposited on the right side of the illustrated treatment area. It is therefore an object of the present invention to correct and / or prevent non-uniform treatment zones and deviations of the treatment zone from under the applicator.

[0090] In various embodiments, more uniform treatment can be achieved by delivering more RF energy to the thicker fat layer side of the applicator and less RF energy to the thinner fat layer side, as described elsewhere herein. The electrodes in this exemplary case are an array of independently switchable skin surface contact electrodes (e.g., 19 electrodes arranged in a hexagonal array in the illustrated example). The electrode array can be electrically insulated but thermally coupled to a water-cooled plate (e.g., as described with reference to Figures 2, 3, etc.). The switchable electrode array allows RF energy to be distributed non-uniformly to tissue to counteract the tendency of the treatment zone to deviate toward the thinnest fat layer. Specifically, deviation can be prevented by increasing the RF power delivered to the thicker fat layer side of the applicator while simultaneously decreasing the RF power conducted to the independent electrodes on the thinner fat layer side of the applicator. This non-uniform applicator power approach allows the treatment zone to remain centered under the applicator despite differences in tissue impedance and / or fat layer thickness.

[0091] FIG. 6E shows a uniform RF power input approach (same approach as described above in connection with FIG. 6C) on the left, while the right shows improved uniformity through redistribution of RF power by providing a non-uniform RF power input to compensate for the non-uniform fat layer. In the left image of FIG. 6E, where a uniform RF power input is provided, the area of ​​maximum temperature is shifted to the right and well outside the dimensions of the applicator. In contrast, the right image of FIG. 6E provides a non-uniform RF applicator power input, modifying the power to compensate for variations in subsurface tissue thickness (e.g., as determined by impedance mapping). In the right image of FIG. 6E, the area of ​​maximum temperature is approximately along the dimensions of the applicator, reflecting the ability of the modified system of various aspects of the teachings of the present invention to generate tissue heating under the applicator regardless of the variations in tissue impedance caused by the non-uniform fat layer. For example, each of the independently switchable electrodes may be operated in a closed loop with respect to power. Each electrode may also function as an individual impedance detector by monitoring delivered amps, V (volts), phase angle, etc. This impedance information may be used to derive a "map" of non-uniformity across tissue layers near the applicator and to "correct" individual electrodes placed over areas of high impedance (e.g., over thick fat layers) to add compensating increments in RF power by providing a starting RF applicator power correction term to the control system. Where individual electrodes are placed over areas with relatively low impedance, RF power is "corrected" to keep a uniform thermal treatment zone centered under the applicator.

[0092] The tissue impedance map approach described above is useful for providing feedback to the control system to redistribute the RF power delivered from each individual electrode (adding a ± correction term to the RF power command) to control treatment to remain within the desired treatment zone centered under the applicator.

[0093] Also, in the case of non-uniform tissue impedance or thickness (e.g., fat layer, etc.), if no correction term is added to the individual electrode power or if the correction is insufficient, the resulting skin surface temperature near the applicator edge may be asymmetric, i.e., the skin surface near the applicator edge that is located on a thinner (low impedance) fat layer tends to be hotter than the skin near the applicator edge that is located on a thicker (high impedance) fat layer. Thus, even if the electrode array is not compensated or is not adequately compensated based on impedance mapping for redistribution of RF power to the individual electrodes, monitoring the increase in skin surface temperature near the applicator edge can provide a useful control feedback mechanism to correct for asymmetries or deviations in the intended treatment zone. In some embodiments, simply monitoring the patient's surface near the edges of the electrodes (a few millimeters away from the edge of the cold patient cooling block) can provide sufficient feedback for a control algorithm to redistribute or correct the RF power delivered to individual electrodes to keep the treatment zone uniform and symmetrical about the center of the applicator (e.g., the treatment zone remains centered under the applicator).

[0094] Thus, in various aspects of the present teachings, the patient surface temperature outside the edges of the actively cooled patient water block and electrode array can be indicative of deeper tissue temperatures (i.e., below the skin surface). Asymmetries in surface temperatures around the applicator edges can indicate, for example, that the resulting "treatment zone" (the zone of tissue temperature rise up to the target temperature) is asymmetric or deviated. Specifically, the individual electrodes closest to the area of ​​the applicator with the greatest skin surface temperature are switched to reduce RF power, while the opposite side of the applicator is switched to increase the duty cycle of the applied RF power. For example, an overheating side of a given electrode array can be shut off (or the duty cycle reduced) in favor of another portion of the same array with a lower skin surface temperature. That is, the skin surface temperature around the edges of the applicator electrode array may indicate the need to vary and control the RF power so that the temperature rise of the skin surface around the edges of the applicator is maintained consistent and homogenous.

[0095] As described above, by maintaining homogeneity in the skin surface temperature rise using either or a combination of monitoring the temperature at the edges of the electrode array and impedance mapping by individually monitoring the impedance of each electrode in the array, feedback can be provided to the control system to homogenize the treatment zone and keep it centered under the applicator electrode array.

[0096] [Impedance measurement and subcutaneous tissue temperature feedback] One of the primary goals of thermal treatments, including those applied to fat destruction and skin tightening, is to raise the temperature of the tissue below the skin's surface to a range of about 39°C to about 47°C, about 39°C to about 44°C, about 41°C to about 42°C, or about 42°C to about 47°C, while maintaining the temperature of the skin surface at a normal temperature of about 35°C or less. However, the temperature at deeper depths is typically unknown or highly invasive techniques are required to monitor the temperature below the surface. Traditionally, it has been difficult to directly estimate the subcutaneous temperature from the surface temperature due to the active cooling that occurs at this tissue surface. Therefore, it has been common to rely on the patient's senses to determine the appropriate heart rate and dosage.

[0097] However, applicants have found that the measured impedance and subcutaneous temperature can be closely related. As previously mentioned, the impedance of the area under the electrode array can be mapped to determine where more or less energy should be applied to compensate for anatomical differences. Through observation of impedance mapping during treatment, a strong correlation has been found between the impedance and temperature of the subsurface tissue. Moreover, this correlation can be applied to a closed loop feedback mechanism for the system to determine the temperature of the subcutaneous volume under a particular electrode, under an electrode cluster, or under an electrode array. One advantage of knowing the temperature under the tissue surface is that it can reduce variation in treatment temperature by compensating for perfusion changes and local anatomical hot spots that can affect the overall sensation.

[0098] The plots described below illustrate exemplary aspects of correlations identified between impedance and subcutaneous tissue temperature. As shown in FIG. 7A, tissue temperature at a depth of 1.5 cm was measured during an exemplary RF treatment with an invasive temperature sensor (a fluorophore-tipped optical fiber that is not affected by RF like a conventional thermocouple). The right vertical axis is power (Watts), the left vertical axis is resultant temperature (° C.), and the horizontal axis is treatment time. As shown, the plot depicts an increase in tissue temperature as the RF power goes through an increasing phase over the first few minutes of treatment, after which the RF power is decreased to maintain the tissue temperature at a fairly constant level of about 45° C. That is, during an initial heating or accumulation phase in which the RF power (or duty cycle) is increased, the target tissue can be raised to a therapeutic temperature range (e.g., 42-47°C, etc.), and thereafter, the RF power (or its duty cycle) can be decreased to maintain the target tissue within the desired therapeutic temperature range (e.g., plateau at about 45°C, etc.).

[0099] FIG. 7B shows another plot of the same exposure process. Instead of temperature, the total impedance change over the exposure time of the electrode array is plotted for two different cooling temperatures, 15° C. (squares) and 28° C. (diamonds). Based on this plot and with the teachings of this specification, a person skilled in the art can see a clear relationship between the increase and plateau phases, that is, the impedance is inversely proportional to the tissue temperature shown in FIG. 7A. Thus, a person skilled in the art can understand from the teachings of this invention that this observation can be used to determine absolute or relative calibration values ​​based on impedance measurements (e.g., delta recordings from the start) that can help maintain the consistency and effectiveness of the RF treatment.

[0100] The plot in FIG. 7B further demonstrates that the sensed impedance generally reflects an offset between different cooling settings (e.g., the lower the temperature, the higher the impedance). In this case, the 15° C. cold water (squares) provides more conductive cooling between the patient's surface and the adjacent tissue layers at greater depths than the 28° C. cold water (diamonds), resulting in a different offset and a different starting apparent impedance. Without being bound by any particular theory, this phenomenon may be due to the lower 15° C. surface temperature resulting in a higher impedance due to blood vessels constricting when tissue is cold. It can be seen that the tissue under the 15° C. water cooling zone starts the electrode at a higher impedance (resistance) than the tissue under the warmer zone (28° C. cold water), resulting in an impedance difference of approximately 19-20 ohms. As noted above, the patient impedance is inversely proportional to the temperature rise at a given depth. By comparing FIG. 7A and FIG. 7B, one skilled in the art will appreciate from the teachings of the present invention that an increase in tissue temperature of approximately 11-12° C. at a depth of 1.5 cm corresponds to a drop in the resistance of the patient's tissue of approximately 19-20 ohms. Moreover, a similar delta or drop in the resistance (impedance) of the patient's tissue is seen in both the 28° C. and 15° C. curves, suggesting similar temperatures at depth. In light of this relationship, various aspects of the teachings of the present invention may utilize the delta impedance that occurs over the course of a treatment to, for example, determine a treatment endpoint or help maintain a consistent treatment temperature at depth, thereby reducing or enhancing side effects of overtreatment. Thus, various aspects of the teachings of the present invention may provide a control scheme in which changes in the patient's tissue impedance during treatment may be monitored and energy delivery to the patient may be increased or decreased to maintain a target drop in resistance (e.g., approximately 19-20 ohms, etc.). That is, the RF signal may be adjusted or modified by a closed loop algorithm to bring the impedance closer to and maintain it at a target value.

[0101] [Multiple treatment pads] In various aspects of the teachings of the present invention, multiple treatment pads may be used. In the simplest configuration of the treatment pad, one array may be used as the "source" and another array may be used as the "return". These two electrode arrays may cover the same area and the clinical endpoints of both areas may be the same. The return electrode in this case provides tissue heating where the return current is exactly the same as the source current, rather than the current simply creating a closed circuit. This approach may also support the use of multiple electrode arrays (e.g., two or more electrode arrays, three or more electrode arrays, etc.).

[0102] [Driving multiple treatment pads] In some aspects, two or more treatment pads (e.g., treatment applicators including electrode arrays, etc.) may be driven in a bipolar or hybrid configuration as described herein with respect to Figures 1A and 1E. In an embodiment where there may be two or more treatment applicators, each may have an active electrode array provided with its own DC power supply and RF drive circuitry (which may be controllable, including voltage and phase, independently of each other).

[0103] The two or more treatment applicators have respective RF drive circuits operating at the same RF frequency, although the treatment applicators may operate at different phases (e.g., not necessarily the same phase as each other). In some embodiments, the RF transformer secondary portions (e.g., the "output" side of each transformer that is coupled to the subject or patient) for the two or more treatment applicators are all connected together and to a single drain electrode.

[0104] In one embodiment, only one active electrode array is used and the drain electrode is the return electrode, in which case all of the RF current flows through both the active electrode array and the drain (return) electrode.

[0105] In other embodiments, two or more active electrode arrays are used while minimizing the amount of current flowing through the drain electrode. The RF applied to each of the two or more active electrodes can be controlled in voltage and / or phase so that all or nearly all of the current flows between the two or more active electrode arrays and the amount of current flowing through the drain electrode is minimized. This approach can be used for any number of active electrode arrays greater than or equal to two, including odd or even numbers of active electrode arrays. For example, using phase adjustment, it is possible to have three active electrode arrays share all the current between the three active electrode arrays while minimizing the current flowing through the drain electrode.

[0106] In the case of multiple active electrode arrays, the drain electrode may be used for two purposes: (1) to monitor the voltage on the body by monitoring the voltage across the secondary portions of the RF transformers (e.g., the output of each transformer that is coupled to the subject or patient), and / or (2) to act as a "drain" or "drain" of a small amount of RF energy when the anatomical structure underlying all or part of a given active RF electrode of two or more active RF electrode arrays is one that requires less current than the remaining active RF electrodes. In such cases, it may be possible to achieve uniform tissue heating or uniform tissue temperature despite differences in anatomy by directing a portion of the current to the drain using phase adjustment to reduce the portion of the current flowing to a given active RF electrode of the multiple active RF electrodes in the array.

[0107] The phasing of the active electrodes may also be adjusted to compensate for the anatomical placement of the various active electrodes, such that in the case of four electrodes, for example two placed adjacent to one another on the body, the active electrodes may be phased so that the two adjacent electrodes are in phase, allowing for effective heating of the desired tissue as one large electrode array without passing current through the skin between the two electrodes.

[0108] Thus, this exemplary architecture allows for the heating of large areas of tissue using any number of active electrode arrays without being constrained by the size of the return electrode, while also allowing for flexibility in the placement of these active electrodes.

[0109] In one exemplary configuration, three treatment applicators may be connected in a Y or star configuration, with each applicator being provided with RF power 120 degrees out of phase with each other, such that the sum of the RF currents at the neutral pads (e.g., drain, return, etc.) is substantially zero (minimizing the amount of current flowing through the drain electrodes). Another exemplary configuration includes an even number of applicators (e.g., two or four treatment applicators, etc.), and the phase angles of the RF power signals to each applicator are shifted by 180 degrees. In the case of four applicators, the phase angles of two of the four applicators can be, for example, 0° and the phase angles of the remaining two applicators can be 180°, such that the RF power returning through the drain electrodes is substantially zero or sums to zero.

[0110] For an even number of applicators, having an equal number of electrodes with a 0° phase angle and an equal number of electrodes with a 180° phase angle can result in a substantially zero or minimal return current flowing through the return pad. For an odd number of applicators, if the number is a multiple of three, having an equal number of applicators operating at each phase angle with a 120° phase difference can result in a substantially zero or minimal return current. For six applicators, for example, an RF signal with a 0° phase angle can be applied to two applicators, a different RF signal with a 120° phase angle can be applied to two other applicators, and a different RF signal with a 240° phase angle can be applied to the remaining two applicators.

[0111] In the case of an odd number of applicators not divisible by 3 (e.g., 5, 7, 11, 13, etc.), the sum of the return currents will not be substantially zero. However, the ± of the return currents will be approximately equal to the RF power delivered to one applicator, and the remaining applicators will all cancel each other out, resulting in a return current that is substantially zero in total.

[0112] In such cases where the number of applicators is an odd number not divisible by three, there may be two equal groups, 180° out of phase with each other, and the remaining applicator may be operated at any phase angle. Alternatively, the number of applicators may be divided into three equal groups, each group operated 120° out of phase with each other, and the remaining applicator not in any group may be operated at any phase angle. In either of these examples (two groups 180° out of phase, or three groups 120° out of phase), the sum of all applicators except one applicator will be essentially zero return current. That is, the sum is not zero, and the ± of the return current will be approximately equal to the return current of one applicator, regardless of any odd number of applicators not divisible by three.

[0113] The utility of the above approach, where the return currents sum to zero (except for one treatment applicator), is that any number of treatment applicators can be used without worrying about overheating the return pad. As a result, a very large area of ​​the body can be treated / covered simultaneously with multiple treatment applicators, while only needing to use one return pad. Optionally, multiple return pads may be used. In this case, the size of each applicator may be increased since the return current (which, as mentioned above, corresponds approximately to only one applicator) is distributed among multiple return pads. This allows the size of the treatment applicator and the number of treatment applicators / electrode arrays to be increased or decreased as appropriate for a given treatment area. In these examples, "substantially zero" assumes that the amount of energy delivered to each treatment applicator is substantially the same (e.g., the underlying anatomical structures are approximately equivalent). However, slight variations in the RF power delivered to each treatment applicator or electrode array due to variations in the anatomical structures underlying each applicator or electrode array can result in a small amount of return current flowing in the drain (return) electrode.

[0114] Reference is now made to FIG. 7C, which illustrates exemplary electronic components of a system 700 according to various aspects of the teachings of the present invention, with inset 700' illustrating a block diagram of one electrode array / applicator. Component 720 represents the return circuit of the neutral electrode. Components 730, 740, 750, and 760 represent four separate RF amplifiers (e.g., RF energy sources, etc.) connected in a Y configuration that can be operated at any phase angle relative to one another. Each RF amplifier is connected to one electrode array / treatment applicator. For example, RF amplifier 730 is connected to electrode array 700'. As shown, a separate adjustable 48 V DC power supply 770 provides power to the four RF power amplifiers. A system controller 780 block determines the operating level and phase angle at which each RF amplifier operates. A separate communication circuit 785 connects each applicator to the system controller 780. The applicator / electrode array controller 790 switches between each electrode in an array and monitors the voltage, current and phase of each electrode in an array. This electrical feedback is used to determine the impedance of each individual electrode in the electrode array / applicator. The controller 790 can adjust the duty cycle of the RF energy applied to each individual electrode in the electrode array to allow for uniform application of thermal energy in the tissue under the array, as described elsewhere herein.

[0115] In some exemplary embodiments, a system for treating a patient's tissue may include two or more treatment applicators that are used to treat one region of the patient's tissue (e.g., the abdomen) or to treat different regions of the patient's tissue (e.g., the upper arm and the thigh). To accommodate either of these two types of treatment, each treatment applicator may include an individually controllable RF energy source, and while each of the RF energy sources may operate at the same fundamental frequency (e.g., a single fundamental frequency), the phase and amplitude of each of the two or more RF energy sources may be controllable. Specifically, the phase and amplitude of each of the two or more RF energy sources may be controlled relative to one another to allow current sharing between the two or more applicators. In various aspects, this ability to share current between the two or more applicators may allow for flexibility in the placement of the applicators on a subject's body, whether the two or more applicators are placed on the same treatment area (e.g., abdomen) or on two separate treatment areas (e.g., one applicator on the upper arm and the other on the thigh) (with appropriate amounts of RF energy delivered to each separate treatment area). For example, in one embodiment where one applicator is placed on the upper arm, excess current passed through the upper arm that is no longer needed to treat the target tissue may be shared (e.g., redirected) with the other applicator to treat thigh tissue, an area of ​​higher tissue density than the arm. In some embodiments, a return or drain electrode may also be used. In various embodiments, each of the two or more treatment applicators can include a plurality of treatment electrodes (e.g., an array of treatment electrodes, etc.) configured to be placed in contact with a surface of a patient's tissue and to deliver RF energy to the surface, the plurality of treatment electrodes having at least two individually addressable treatment electrodes to which an RF signal can be applied.

[0116] [Drain Pad] A drain pad may be used, for example, to balance the two treatment pads: when multiple arrays are being used, if one array heats up faster than the other, it may be necessary to drain some of the RF energy to a third, non-treatment return electrode.

[0117] [Changes in water temperature] Changes in water temperature can be effected by changing the refrigerant set point (thereby changing the skin heating profile). Lower temperatures push the heating zone deeper, while higher water temperatures pull the zone towards the dermis to create tightening. In various embodiments, the circulating water can be configured to maintain the skin temperature within a range of about 15-35° C. during treatment. As discussed elsewhere herein, adjustments can be made to provide sensation / patient comfort and / or to control the depth of the heating zone.

[0118] [RF adjustment] Modulation of RF power may be used to improve sensation (e.g., reduce pain for the patient). For example, it may be possible to confine thermal treatment to only the tissues above the deeper target tissues (e.g., epidermal and / or dermal tissues, etc.) while maintaining the temperature of the tissues below the injury threshold (i.e., below about 46-47°C). For example, RF treatment parameters (delivery pattern, power, pulse length, etc.) may be adjusted during the treatment time. In some embodiments, the temperature profile / gradient in the target tissue (e.g., tissue near or below the dermal / subcutaneous junction, such as subcutaneous tissue, etc.) during treatment may be optimized by taking into account the cooling rate at the surface of the skin.

[0119] [Electrode Sampling] Preferably, sampling of each individual electrode for control purposes may be done at a frequency that avoids muscle nerve weakening. The base frequency may be 0.5-4 MHz (lower frequencies may be desirable to reduce crosstalk between electrodes). The control loop may operate at a frequency of around 100 Hz. Adjustment of the duty cycle of each electrode is preferably staggered to reduce the effects of nerve weakening.

[0120] Exemplary Treatments of Mucosal Tissue As previously mentioned, the systems and methods of various aspects of the teachings of the present invention may also be used to treat various internal tissues by applying RF energy to the mucosal tissue surface with a water-cooled treatment electrode or treatment electrode array operating in a monopolar or bipolar manner, and propagating the RF energy from the mucosal tissue surface to deeper tissue layers. In such aspects, tissue remodeling may be achieved, for example, by RF energy penetrating the tissue to generate heat in sub-tissue surface areas (possibly while protecting overlying tissue with cooling). In some embodiments, the RF electrode array for treating mucosal tissue is not cooled. Although the following description refers to exemplary treatments of the vagina (e.g., vaginal relaxation, rejuvenation, urinary incontinence, other urogenital conditions, etc.), it will be appreciated that the teachings of the present invention are applicable to perform desired treatments on other internal tissue surfaces (e.g., esophagus, oral cavity, treatment of fecal incontinence, digestive tract, etc.).

[0121] For example, stress urinary incontinence (SUI) is a condition characterized by the inability to stop involuntary urination when pressure is applied to the body (e.g., coughing, sneezing, strenuous physical activity, etc.). It is generally the result of weakened muscles around the bladder neck and urethra. SUI is often reported in postmenopausal women and is thought to be related to vaginal changes that occur at menopause that weaken the vaginal wall and the muscles located between the vaginal wall and the urethra. Although surgical intervention is known and often necessary in severe cases of vaginal laxity, surgery is often undesirable due to cost, recovery time, side effects and complications. Thus, there has been a long felt need for non-surgical devices and methods to treat SUI and other urogenital conditions, especially in women.

[0122] In various embodiments, the methods and systems of the present teachings may deliver a controlled amount of heat by applying RF energy to the vaginal wall to remodel tissue, such as the anterior vaginal wall, to treat SUI. The tissue may be the vaginal wall itself, or may be tissue near the vagina, near the urethra. For example, the target area for localized heating may be tissue between the vaginal wall and the mid-urethra. In certain embodiments, the target tissue may be heated to about 40° C. to about 45° C., about 41° C. to about 43° C., or about 42° C. (e.g., without surface cooling). RF energy may be applied for a period of time, preferably less than 30 minutes or less than 10 minutes, and in some cases less than 5 minutes. For example, RF energy may be applied for about 1 minute to achieve a desired temperature in the target tissue area, and may continue to be applied to maintain the desired temperature for about 5 minutes. The heat source may then be de-energized and the cooled treatment probe may be removed from the vagina. In some cases, the entire process may be completed in less than 10 minutes. Optionally, when surface cooling of mucosal tissue (e.g., vaginal tissue, etc.) is applied, the tissue may be heated to a temperature greater than the range of about 40°C to about 45°C, e.g., about 40°C to about 70°C or about 45°C to about 60°C.

[0123] In a given aspect, the method may comprise applying RF energy to the anterior vaginal wall to a treatment depth of about 2-9 cm, preferably about 5-8 cm, and more specifically about 7 cm from the outer vaginal wall surface. In such an embodiment, this anterior portion includes the portion of the vaginal wall closest to the urethra, approximately 120°, such as the 10-2 o'clock, 11-1 o'clock, 11:30-12:30, etc. (where 12 o'clock is considered to be the portion of the vaginal wall closest to the urethra).

[0124] In certain embodiments, it may be desirable to heat the entire target volume uniformly. As discussed elsewhere herein, there are various ways to ensure uniform heating by varying the power delivered by individual electrodes. However, in some embodiments, the methods of the present invention may also include using an electrode array to deliver heat to multiple tissue sites within the target region. This localized heating creates a lattice of thermal islands, each surrounded by relatively unaffected tissue. Such "localized" treatment may be a desirable approach to tissue reconstruction, since it causes damage within small sub-volumes or islands within a larger treated volume. The resulting islands are surrounded by nearby healthy tissue that is substantially undamaged, allowing the healing process to be complete and rapid.

[0125] Disclosed are devices and methods for treating female urogenital conditions, such as urinary incontinence (particularly stress urinary incontinence), that remodel tissue in the anterior region of the vaginal wall and / or in the muscles adjacent to the vaginal wall, near the urethra.

[0126] The device may include a probe configured for vaginal insertion having a surface configured to apply heat to the anterior vaginal wall. In certain embodiments, the probe may take the form of an elongated cylinder or wand having at least one treatment pad (e.g., an array of RF energy emitting electrodes) to deliver energy to tissue in contact with or adjacent to the probe. As previously described, each electrode in the array may be individually addressable and energized. These individually programmable electrodes in the array may allow for the delivery of tailored treatments as well as function as sensors when unactuated, allowing for the control of applied energy to achieve a desired heating regime and homogeneity of treatment within a target region, despite variations in the electrical impedance and anatomy of the patient's underlying tissue.

[0127] The probe may also include at least one temperature sensor for monitoring 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 blackbody radiation emitted by heated tissue. Alternatively, temperature monitoring may be achieved by one or more of the electrodes operating as impedance measuring electrodes. The relationship between impedance changes and temperature is as described herein. The probe may also include a cooling pad to prevent overheating of the vaginal wall surface, thereby allowing heat to be delivered primarily to the subsurface target tissue region.

[0128] In certain embodiments, the probe may include an array of pads or electrodes, which may be programmable to allow some of the elements of the array to be energized to deliver heat to specific regions or in specific patterns. For example, RF electrodes may be distributed over all or part of the surface of the probe to heat the entire vaginal vault or a portion of the vaginal wall. Multiple electrodes allow for monopolar treatment (characterized by an energy path from at least one electrode to a remotely located return pad) as well as bipolar treatment (treatment in which energy flows between electrodes). Also, in certain embodiments, the multiple electrodes may be used to monitor tissue impedance (or simply resistance) to map the tissue beneath the electrodes and / or to further control the treatment. For example, adjusting the power delivered to individual electrodes based on this tissue impedance map may allow for homogenization of the temperature rise across the treatment area. Individual electrode output power may be controlled (e.g., by gate duty ratio, etc.) to allow the physician to obtain a controlled and consistent tissue temperature rise across the treatment tissue area. This is particularly useful where the device is secured to the anatomy and energized and then only requires monitoring by a physician or assistant.

[0129] Also, in a given embodiment, the probe may include at least one fixation device. For example, the probe may be provided with a locking sleeve or sheath that can be inserted into the vagina before use to fix the probe in place at the desired orientation and depth for the procedure. The probe may also include at least one expandable element that can be expanded after the probe is inserted to properly contact the energy delivery element of the probe to the anterior vaginal wall. The device of the present invention may be handheld or computer controlled. The probe may have markings to indicate the insertion depth.

[0130] The teachings of the present invention also encompass a system incorporating various devices, including, for example, a controller, a power supply, a coolant containment, a monitor, an alarm, etc. The various devices may be incorporated in whole or in part into a console that provides a graphical user interface and displays various parameters. The system may also include an imaging element located on the probe itself or partially within the probe and used with an attached transurethral catheter to assist in identifying the target tissue region. Alternatively, the probe may be used with a stand-alone imaging system (e.g., ultrasound imaging, x-ray imaging, fluoroscopic imaging, etc.).

[0131] In other embodiments, the devices and methods disclosed herein may be used to treat other urogenital conditions by delivering controlled patterns of heat or RF energy to other areas of the vagina. The present invention may also be used to rejuvenate vaginal tissue in general and to alleviate various postmenopausal genitourinary tract symptoms (GSM).

[0132] It is believed that the proximity of the urethra to the vagina influences the improvement of SUI symptoms. Furthermore, without being bound to any particular theory, it is believed that heating the vaginal wall and the adjacent tissue between the vagina and the urethra results in tissue remodeling through targeted tissue shrinkage, collagen regeneration, nerve attenuation, or a combination thereof, thereby improving urinary incontinence symptoms.

[0133] Reference is now made to FIG. 8, which illustrates a schematic diagram of an exemplary system 800 according to various aspects of the present teachings. As illustrated, the system 800 includes a console 810 that houses an RF generator and other electronic components (e.g., at least one microprocessor, etc.) and provides a display 832, e.g., of operating parameters, etc. The display 832 may be, e.g., a pressure-sensitive screen, etc., that provides a graphical user interface (GUI), and / or the console 810 may separately provide user controls 811. As previously discussed, while some exemplary applicators have been described herein as being substantially flat (rigid or flexible) electrode arrays, the applicators in some exemplary aspects may be configured for insertion into a patient (e.g., through a lumen or natural body orifice, etc.) to apply RF energy to a mucosal tissue surface (e.g., vaginal wall, esophageal lining, etc.). For example, as shown in FIG. 8, the applicator may include a generally cylindrical probe 830 (e.g., a wand-like applicator, etc.) that may be sized and shaped to be inserted into the vagina or esophagus to administer RF treatment thereto. The console 810 may be connected to this temperature-controlled intelligent probe 830 by a cable or umbilical 833 that may provide RF energy to the probe 830 from, for example, a generator located within the console 810. In certain embodiments, the console 810 may also house a coolant source that provides circulating coolant to the applicator probe 830 via the cable or umbilical 833, as described elsewhere herein. In certain embodiments, the probe 830 may alternatively be wireless and may include its own RF generator, electronics, cooling, and power source (e.g., a rechargeable battery, etc.).

[0134] As shown in FIG. 8, the probe 830 can be used to heat tissue and can have, for example, between 200 and several hundred individual probes each having an area of ​​about 1 cm. 2The probe 830 may include, but is not limited to, an array 860 of electrodes 862, which may be, for example, a single electrode 862a, a single electrode 862b, a single electrode 862c, a single electrode 862d, a single electrode 862e, a single electrode 862f ... 8, the probe 830 can include at least one temperature sensor 842. In various embodiments, the probe 830 can also have markings 844 to indicate the depth of insertion of the probe 830 into the vagina.

[0135] 9, system 800 may also include a locking sleeve or sheath 850 (or introducer) that may be useful to guide the procedure, for example, to facilitate insertion and / or align and / or set depth based on sounds made at the bladder neck by a Foley catheter or sounds made naturally in the vagina. For example, probe 830 may have grooves 851a that mate with corresponding ridges 851b in introducer 850 (although other matching or locking mechanisms may be substituted, as will be appreciated by those skilled in the art from the teachings herein).

[0136] Reference is now made to Figures 10A-10C, which show schematic diagrams of an exemplary method for treating SUI in accordance with various embodiments of the present teachings. Specifically, Figure 10A shows a schematic diagram of the female urogenital tract, including a uterus 802, a vagina 804, a bladder 806, and a urethra 808. At the vaginal introitus, the urethra 808 is in anatomical proximity to the vaginal wall. However, as the urethra 808 approaches the bladder neck, it separates from the vaginal wall. In various exemplary embodiments, this is the area targeted for RF-based thermal therapy (e.g., near the mid-urethra, etc.).

[0137] Reference is now made to Figure 10B, which illustrates the insertion of a catheter 801 (e.g., a Foley catheter, etc.) after insertion into the urethra 808. As shown, the catheter 801 can be inserted into the urethra 808 until the distal end of the catheter 801 reaches the bladder 806, after which a balloon 803 can be inflated to stabilize and secure the catheter 801 in place. The overall length of the urethra can be identified by the meatus and where the urethra terminates at the bladder neck. Identifying the bladder neck is a common clinical practice, performed by inserting a catheter, inflating a balloon, and then retracting the balloon until it meets the neck.

[0138] In certain aspects, the catheter 810 may include at least one temperature sensor 805 disposed along the length of the catheter 810. The at least one temperature sensor 805 may be configured, for example, to measure a temperature rise at the urethra 808 and / or monitor the temperature of tissue opposite the tissue-electrode interface (e.g., the portion of the target tissue to be heated). The catheter 801 may also be connected to the console 810 of FIG. 8 to monitor impedance to ensure contact between the probe electrode 862 (e.g., an individually monitorable electrode) and the vaginal wall, thereby allowing current flow to the RF probe 830 to be controlled, as described elsewhere herein.

[0139] As previously discussed, in certain embodiments, the target region (e.g., near the mid-urethra, etc.) targeted for RF-based thermal treatment may be located near the mid-urethra where the urethra 808 leaves (e.g., diverges) from the vaginal wall. In various exemplary embodiments, the target region 809 may be tissue located beyond the vaginal wall between the vagina 804 and the urethra 808. To heat this region by application of RF energy, the electrode 862 of the probe is preferably positioned against the anterior wall of the vaginal vault, as shown in FIG. 10B.

[0140] 10C, an exemplary procedure according to various embodiments of the present teachings is shown in which a probe 830 is placed against a desired area of ​​the vaginal wall and at least one electrode 862 may apply RF to the vaginal wall to heat the vaginal wall. For example, if it is desired to heat a larger length or width of vaginal tissue without manual movement (or to automate the procedure), it may be possible to apply RF energy using two or more electrodes 862 simultaneously. In various exemplary embodiments, the probe 830 may further include an inflatable balloon 832 for stabilizing the probe 830 against the vaginal wall surface. As discussed elsewhere herein, the electrodes 862 may be connected to a common node (e.g., at least one electrode cluster, etc.) or may be individually controlled, for example, to provide power only to the electrode in contact with the vaginal wall, etc. In various embodiments, each of the electrodes 862 (or groups of electrodes 862) may be energized to apply RF energy to the target tissue in a monopolar or bipolar manner. Alternatively, during vaginal treatment, a return pad (such as pad 130e of FIG. 1C) may be placed on the surface of the skin (e.g., near the pubic area or on a portion of the patient's thigh) to provide a return path for RF energy applied by electrode 862 to the mucosal lining of the vagina 804. Alternatively, the catheter 801 in various embodiments may act as a return path to focus energy on tissue between the vagina 804 and the urethra 808. This configuration may help focus tissue heating on the vaginal wall immediately adjacent the urethra 808, any muscle between the urethra 808 and the vaginal wall, and the urethra 808 itself. In yet other embodiments, the electrodes 862 of the probe may be bipolar, with one electrode 862 (or a group of electrodes) in the array 860 acting as a therapeutic "active" electrode that radiates RF energy, while at least one other electrode in the array 860 acts as a "return" (ground) electrode to provide an electrical return path for the RF energy. In certain embodiments, pulsed RF, which concentrates high energy in a short pulse, may be preferred.

[0141] In certain embodiments, a hands-free setup may be preferred. For example, after pinging at the vagina or bladder neck, the physician may adjust the probe 830 to apply RF to the correct zone along the urethra 808, secure the probe 830 in place using balloon 832 or other means, and use feedback to determine that the probe 830 (and its electrodes 862) are in contact before beginning RF application. This allows the probe 830 in various embodiments of the present teachings to begin operation to apply RF energy uniformly and / or maintain a desired uniform temperature range in the target area and / or provide a consistent dose and / or cool the surface, as described elsewhere herein.

[0142] For example, the probe 830 may further include a cooling mechanism 835, such as at least one cooling surface interspersed with the electrodes 862, for cooling the vaginal wall surface by circulating a refrigerant through the probe 830. Alternatively, in various embodiments, cooling may be achieved by the use of a thermoelectric (Peltier) element or a phase change material (e.g., ice, etc.) in thermal contact with the patient contact surface (e.g., via the electrodes, etc.). As discussed elsewhere herein, controlling the temperature of the electrode-tissue interface may be useful for controlling the depth of the target tissue. Cooling allows for modification of the therapeutic goal without being limited in heating the target tissue by patient tolerance (e.g., in the range of about 40°C to about 45°C, etc.). Cooling may, for example, increase the target temperature to a temperature within the range of about 40°C to about 70°C or about 45°C to about 60°C.

[0143] Reference is now made to FIG. 11, which illustrates another exemplary probe 1130 according to various aspects of the teachings of the present invention. As illustrated, the probe 1130 may include multiple separate electrodes 1162 disposed over the entire surface of the probe 1130 rather than at a distal anterior region of the probe. As can be appreciated from the teachings of the present invention, advantages of such a probe 1130 include the ability to treat the entire vagina 804 by switching different electrodes on and off. This type of probe (electrodes over the entire surface) may be capable of treating vaginal conditions (rejuvenation) throughout the vagina in addition to SUI. However, if it is desired to address only the SUI treatment target tissue area, the electrodes 1162 within the desired anterior vaginal region (e.g., between 10 o'clock and 2 o'clock) are energized while the other electrodes are kept off. Furthermore, such a probe may allow the physician to adjust beyond the 10 o'clock and 2 o'clock positions, for example by energizing more electrodes, thereby allowing treatment of a larger area of ​​tissue up to the entire circumference of the vagina. Similarly, such a probe may allow the physician to adjust the range from the 10 o'clock position to the 2 o'clock position, e.g., by energizing fewer electrodes, thereby allowing treatment of smaller areas of tissue. Thus, any desired area (or the entire vagina) may be selected for treatment.

[0144] Various aspects of the control of RF treatment may be based on feedback from multiple temperature sensors along the urethra. If the urethra itself is the heating target for stimulating tissue and surrounding muscle tissue, then having monitoring means within the urethra can help standardize clinical efficacy and greatly improve safety. That is, monitoring temperature at separate points along the catheter can be useful to enable detection of any thermal anomalies (e.g., hot spots, etc.). Additionally or alternatively, these separate temperature sensors may provide information for determining treatment endpoints. That is, monitoring the actual tissue temperature rise upon application of RF energy can compensate for variations in patient anatomy and tissue perfusion.

[0145] In various embodiments, the long pulse length and low irradiance (approximately 1-5 W / cm2) described herein can also be used for internal tissue. 2 ) regime and short pulse length, high fluence (approximately 10-1000 J / cm 2) regimes can be envisioned, each of which may have contrasting effects on biological target selection and biological subject treatment. Without being bound by any particular theory, the method of action may be thermal in nature, with selected tissue being heated (and in some cases coagulated) by the delivered RF power. In the case of long continuous exposure, uniform heating of the structure may be achieved. In the case of short bursts of focused energy, a point of ablated tissue may be formed. Also, in various embodiments, it may be desirable to ensure uniformity of the delivered RF energy. In some applications, it may be desirable to not only raise the temperature of the target tissue to a given temperature range, but also to hold the target tissue in the target region at the elevated target temperature for a given period of time to provide an effective treatment. That is, by maintaining the temperature for a given period of time, a desired clinical effect may be achieved. Also, as discussed elsewhere herein, it may be advantageous to actively control the RF energy to distribute the energy homogeneously, uniformly, predictably, and automatically (e.g., without user intervention) throughout the target tissue in the target treatment zone. Also, the pulse length of the RF pulse may allow for the selection and / or targeting of specific tissues. By focusing a short pulse length, high amplitude RF pulse on a narrow electrode-tissue interface area, it may be possible to generate sufficient flux or current density to coagulate and vaporize tissue, thereby providing the "localized" treatment described above.

[0146] Reference is now made to FIG. 12, which illustrates another exemplary system 1200 in accordance with the teachings of the present invention. As illustrated, the system 1200 may include a console 1210, a coolant source 1238, a microprocessor 1237, an RF power source 1235, a switching control 1211, and a measurement circuit 1213 (which may be separate or housed together in a single console 1210). The system 1200 further includes at least one probe 1230a having an array 1260a of electrodes 1262a. Each electrode 1262a in the array 1260a may be independently switched by the switching control 1211 to conduct RF energy to each electrode in the array. Each electrode not actively receiving RF energy may be monitored by the measurement circuit 1213 to function as a signal channel providing feedback of current and / or voltage and / or phase angle useful for calculating power and impedance at each individual electrode 1262a. Optionally, the system 1200 may further include a second probe 1230b that provides an electrical return path. The probe 1230b may also include an array 1260b that delivers RF energy or may include an array 1260b that provides other mechanisms for detecting impedance and / or other electrical parameters and / or temperature. In some embodiments, the probe 1230b may be incorporated into a catheter for placement into the patient's urethra. Alternatively or additionally, the system 1200 may also include a return (ground or neutral) pad 1230e that is coupled to the patient, for example to provide a drain for the applied current.

[0147] As described elsewhere herein, electrode arrays suitable for use on internal tissue surfaces may also take a variety of configurations in accordance with the teachings of the present invention. For example, the electrode array may be configured as a probe with a metallic coolant housing, with an electrically insulating and thermally conductive layer (e.g., Kapton® polyimide, ceramic such as AlO2) between the coolant circuit and the electrode array. The electrode array may be adhesively attached to the applicator's coolant housing to allow a circulating coolant (e.g., cold water from a coolant source) to cool the electrode array and the patient's internal tissue surface in contact with the electrodes (e.g., vaginal wall, etc.).

[0148] In various exemplary embodiments, for example, the electrode array applicator may include 50 individually controllable electrodes arranged in a square, circular, or hexagonal pattern. Additionally or alternatively, the surface temperature of the patient's tissue surface (e.g., vaginal wall, etc.) in an area around the periphery of the electrode array of the applicator may be monitored, for example, but not limited to, an IR sensor, thermocouple, etc., to identify uneven heating of the vaginal wall surface area near the intended treatment zone. Based on these signals, a microprocessor or algorithm may provide correction factors to the RF power set points of the individual electrodes to optimize treatment uniformity, homogeneity, and treatment zone placement. In various embodiments, the impedance of the electrodes may be monitored individually, as described elsewhere herein, and the microprocessor or algorithm may use the impedance to define a map of the patient's impedance topography and to provide correction factors for varying the RF power set points to optimize treatment uniformity, homogeneity, and treatment zone placement.

[0149] Cooling the patient's internal tissue surface (e.g., mucosal lining, vaginal wall, etc.) where the electrodes are located can protect the tissue surface and increase patient comfort during and after treatment. With sufficient surface cooling (e.g., cooling the probe to about 10°C-35°C with circulating water), high amplitude RF power can be applied safely and comfortably. This may be desirable because most target tissues are located at some depth below the internal tissue surface (e.g., vaginal wall surface), and surface cooling can protect intervening non-target tissue layers while allowing heat to be delivered to deeper tissues. Because mucosal tissues tend to have nerve endings near the surface, cooling the tissue surface can allow the patient to tolerate higher temperatures below the cooled surface at the desired treatment depth.

[0150] As mentioned above, an array of individually switchable electrodes (e.g., individually controllable electrodes whose RF power delivery can be adjusted / controlled independently of each other) can be provided to ensure or help control maintaining a centered (under the electrode array applicator) treatment zone and maintaining a uniform and consistent temperature rise within a desired treatment area, regardless of electrical impedance variations and anatomy of the patient's subsurface tissue. Each electrode (or a portion of electrodes) in the array can be individually addressable and energized. For example, a map of impedance for the entire vaginal vault can be generated and based on this impedance information, energizing only certain electrodes to avoid non-target structures. Surface temperature of the vaginal wall (and / or urethra) can also be monitored and used to compensate for RF uniformity. Applying uniform RF energy (e.g., at frequencies of about 1 MHz) through the vaginal wall to deeper tissues is complicated by different tissue types and impedance changes. For example, fibrous structures and connective tissues have a lower impedance to RF energy than fat. As a result, RF energy will preferentially travel along fibrous connective tissue rather than fat. The heated connective tissue will then thermally diffuse and / or conduct heat from the fibers to nearby fat cells, increasing their temperature. Similarly, muscle tissue may have a much lower impedance than other tissue types. Since predictable RF uniformity is important to the efficacy and safety of applied RF treatments, it is desirable to take into account the non-homogeneous tissue structure in the target area. Some tissue structures have higher impedance than others (e.g., deeper muscle tissue), so even if RF energy is delivered uniformly to the surface, it may "deviation" (swerve) toward the lowest impedance. RF energy typically travels to deeper tissues through the shortest path length in the high impedance layer closest to the vaginal wall.Thus, as described elsewhere herein, only one electrode (or only a portion of an electrode array) may be energized based on tissue feedback (e.g., based on impedance and / or temperature feedback, etc.), and / or the power, length, duty cycle, etc. of the RF signal supplied to each electrode may be individually adjusted to help uniform heating.

[0151] As described above in accordance with various aspects of the teachings of the present invention, different RF pulse lengths may be used to select treated tissues and / or perform different treatments. For internal tissues, for example, longer pulse lengths (e.g., greater than 1 second, CW, etc.), lower power RF energy (e.g., about 1 to about 5 W / cm2) may be used. 2 regimens with short pulse lengths (e.g., less than 500 ms, less than 100 ms, etc.), high energy RF pulses (e.g., about 10 to about 1000 J / cm per pulse) 2 , 10 J / cm 2 ~500 J / cm 2 , 10 J / cm 2 ~300 J / cm 2 , 10 J / cm 2 ~100 J / cm 2 etc.) regimens may be envisioned. In some embodiments, short pulse length, high amplitude RF energy pulses may be used to generate sufficient flux or current density to cauterize and / or coagulate and / or vaporize tissue. For example, RF pulses may be concentrated (e.g., focused) to a narrow region of the electrode-tissue interface to generate sufficient flux or current density to coagulate and vaporize tissue.

[0152] Please refer to FIG. 13, which shows the results of an exemplary RF-based treatment on a bovine liver where the electrode arrays are spaced and configured to deliver heat to multiple tissue locations within a target region, resulting in treated sites separated by non-treated sites. Specifically, the exemplary electrode arrays each have 20 electrodes, and an RF signal is applied to the electrodes while they are in contact with the liver surface. The RF signal is pulsed for 25 milliseconds, and the pulse energy (per electrode) of each electrode of the 20-electrode array is about 30 mJ. As shown in FIG. 13, the exemplary treatment can be applied to multiple, spaced apart islands within a large volume to inflict damage (e.g., cauterize, coagulate, etc.). In such a "partial" treatment, the damaged islands (vaporized tissue) are surrounded by healthy tissue that is substantially undamaged by the application of RF energy. In various embodiments, the healing process of the damaged islands of tissue can be enhanced by adjacent undamaged (e.g., healthy) tissue.

[0153] 14A-14C show another exemplary "partial" treatment result. In these figures, RF signals are applied to two electrode arrays each having 20 electrodes, both with the same pulse energy of about 30 mJ (per electrode in each array), but with different pulse lengths. FIG. 14A shows, for example, multiple isolated islands (of vaporized tissue) on the surface of the patient's skin resulting from an RF pulse length and energy of 35 ms applied to each electrode in the array. FIG. 14B shows multiple isolated islands using a 25 ms pulse length, and FIG. 14C shows multiple isolated islands using a 12 ms pulse length. It can be seen that a shorter pulse length can produce more point damage (e.g., tissue vaporization) even with the same energy per pulse.

[0154] It should be understood that various modifications can be made to the disclosed embodiments without departing from the scope of the teachings of the present invention. Although specific components are mentioned in the above figures and examples, this is merely for illustration purposes and is not intended to limit the present invention. Those skilled in the art will understand that various modifications can be made to the configuration and details of the disclosed embodiments without departing from the scope of the teachings contained in the appended claims. The present invention includes the following aspects: [Aspect 1] 1. A system for treating tissue of a patient, comprising: A source of RF energy; a treatment applicator including a plurality of treatment electrodes configured to be placed in contact with a tissue surface, the tissue surface being a surface of a patient's tissue, and configured to deliver RF energy to the tissue surface, the plurality of treatment electrodes having at least two individually addressable treatment electrodes to which different treatment RF signals can be applied, the treatment RF signals exhibiting one or more of power, duty cycle, pulse length, phase, and RF frequency; at least one return electrode; a cooling mechanism for cooling the tissue surface in contact with the plurality of treatment electrodes; a control means configured to measure the impedance of each of the at least two individually addressable treatment electrodes; wherein the control means is further configured to adjust the treatment RF signals simultaneously applied to the at least two individually addressable treatment electrodes based on impedance of the at least two individually addressable treatment electrodes so as to maintain heating uniformity in a target tissue located beneath the treatment applicator. [Aspect 2] 2. The system of claim 1, wherein the tissue surface comprises a surface of the skin. [Aspect 3] 2. The system of claim 1, wherein the tissue surface comprises a surface of a mucosal tissue. Aspect 4 4. The system of claim 3, wherein the at least one return electrode is positioned on the surface of the skin. Aspect 5 In the system of aspect 1, the different RF signals applied simultaneously to the at least two individually addressable treatment electrodes have different powers. Aspect 6 6. The system of claim 5, wherein the control means is configured to reduce the power of the RF signal to an electrode having a lower impedance of the at least two individually addressable treatment electrodes. Aspect 7 2. The system of claim 1, wherein the different RF signals applied simultaneously to the at least two individually addressable treatment electrodes have different pulse widths. Aspect 8 In the system described in aspect 1, the different RF signals applied simultaneously to the at least two individually addressable treatment electrodes have different duty ratios. Aspect 9 In the system of aspect 1, the different RF signals applied simultaneously to the at least two individually addressable treatment electrodes have different RF frequencies. Aspect 10 In the system of aspect 1, the different RF signals applied simultaneously to the at least two individually addressable treatment electrodes include RF signals of different phases. Aspect 11 In the system described in aspect 1, the at least two individually addressable treatment electrodes include at least two groups of individually addressable treatment electrodes, each treatment electrode in each group of individually addressable treatment electrodes being configured such that the RF signal simultaneously applied to each treatment electrode is the same as the other treatment electrodes in that group, and each group of individually addressable treatment electrodes is configured such that the RF signal simultaneously applied to each group is different from the other groups of individually addressable treatment electrodes. Aspect 12 In the system described in aspect 1, a second treatment applicator configured to be placed in contact with a tissue surface separate from the tissue surface on which the first treatment applicator is placed includes the at least one return electrode. Aspect 13 In the system described in aspect 12, the second treatment applicator includes a second plurality of treatment electrodes configured to be placed in contact with a tissue surface that is a surface of a patient's tissue and to deliver RF energy to the tissue surface, and the second plurality of treatment electrodes has at least two individually addressable treatment electrodes to which different RF signals can be applied. Aspect 14 The system of claim 13, wherein the control means is configured to energize only one of the individually addressable treatment electrodes in each of the first and second treatment applicators at a given time. Aspect 15 16. The system of claim 13, wherein the control means is configured to measure impedance between each of the at least two individually addressable treatment electrodes on the first treatment applicator and each of the at least two individually addressable treatment electrodes on the second treatment applicator. In the system described in aspect 15, the control means is configured to measure impedance between each of the at least two individually addressable treatment electrodes in the first treatment applicator and each of the at least two individually addressable treatment electrodes in the second treatment applicator by generating a sub-treatment threshold RF current therebetween prior to applying a treatment RF signal to the first plurality of electrodes. Aspect 17 In the system described in aspect 15, the control means is configured to measure impedance between each of the at least two individually addressable treatment electrodes on the first treatment applicator and each of the at least two individually addressable treatment electrodes on the second treatment applicator while applying a treatment RF signal to a first of the plurality of electrodes to determine when to stop the treatment RF signal and end treatment. Aspect 18 In the system described in aspect 12, the second treatment applicator includes a cooling mechanism that cools the tissue surface in contact with the multiple electrodes of the second treatment applicator. Aspect 19 In the system described in aspect 1, the return electrode is a passive electrode configured to be placed in contact with a tissue surface remote from the tissue surface on which the first treatment applicator is placed. Aspect 20 20. The system of claim 19, wherein the passive electrode comprises a drain pad. Aspect 21 The system according to embodiment 19, further comprising: a second treatment applicator configured to be placed in contact with a tissue surface remote from the tissue surface on which the first treatment applicator is placed and the tissue surface on which the passive electrode is placed; the second treatment applicator including a second plurality of treatment electrodes configured to be placed in contact with a tissue surface, the tissue surface being a surface of a patient's tissue, and to deliver RF energy to the tissue surface. Aspect 22 2. The system of claim 1, wherein the control means is configured to individually poll each of the at least two individually addressable treatment electrodes with a low power sub-treatment threshold RF signal. Aspect 23 2. The system of claim 1, wherein the treatment RF signal is configured to reduce skin laxity by stimulating collagen production. Aspect 24 2. The system of claim 1, wherein the treatment RF signal is configured to reduce the appearance of cellulite. Aspect 25 In the system of embodiment 24, each electrode has an energy per pulse of about 10 J / cm 2 ~about 1000 J / cm 2 wherein the pulse width of the RF signal is less than about 500 milliseconds. Aspect 26 2. The system of claim 1, wherein the treatment RF signal is configured to cause lipolysis of adipose tissue underlying the tissue surface. Aspect 27 In the system of embodiment 26, each electrode has a power of about 1 W / cm 2 ~about 5 W / cm 2 wherein the pulse width of the RF signal is greater than about 1 second. Aspect 28 2. The system of claim 1, wherein the cooling mechanism comprises a circulating fluid. Aspect 29 In the system described in aspect 28, the temperature of the circulating fluid is controlled by a temperature regulating means so that the target tissue area located below the tissue surface is maintained at a temperature within the range of about 42°C to about 47°C for a treatment time within the range of about 10 minutes to about 30 minutes. Aspect 30 30. The system of claim 28, wherein the circulating fluid is water. Aspect 31 In the system described in aspect 28, at least a portion of the fluid path of the circulating fluid is in thermal contact with a side of the electrode that is not configured to contact the tissue surface. Aspect 32 The system of claim 28, wherein at least a portion of a fluid path of the circulating fluid is in thermal contact with the tissue surface at a location between adjacent electrodes of the plurality of treatment electrodes. Aspect 33 2. The system of claim 1, wherein the cooling mechanism includes one of a thermoelectric element and a phase change material positioned in thermal contact with the electrode in the applicator. Aspect 34 The system according to embodiment 1, further comprising: at least one temperature sensing means for sensing the temperature of the tissue surface in the periphery of the electrode array; wherein the control means is further configured to reduce the power of the treatment RF signal applied to an electrode on a side of the applicator having the highest temperature. Aspect 35 The system according to embodiment 1, further comprising: at least one temperature sensing means for sensing the temperature of the tissue surface in the periphery of the electrode array; wherein the control means is further configured to increase a power of the treatment RF signal applied to an electrode on a side of the applicator opposite a side having a coldest temperature. Aspect 36 In the system described in aspect 1, the RF energy source includes at least two individually controllable RF energy sources, each of which is configured to operate at the same fundamental frequency, while the RF signals generated by each of the individually controllable RF energy sources can have different phases and amplitudes, and the system includes at least two treatment applicators, each connected to one of the at least two individually controllable RF energy sources, and current can be shared between the at least two treatment applicators to enable the at least two applicators to be positioned at two or more separate treatment areas of a subject's body, and each of the at least two applicators is configured to deliver an appropriate amount of RF energy to each of the separate treatment areas. Aspect 37 1. A system for treating the skin of a patient, comprising: A source of RF energy; a treatment applicator including a treatment electrode configured to be placed in contact with a tissue surface, the tissue surface being a surface of the patient's tissue, and to deliver RF energy to the tissue surface; at least one return electrode; a cooling mechanism for cooling the tissue surface in contact with the electrode; a control means configured to apply an RF signal to the treatment electrode, the RF signal having a pulse length that selectively heats septa in fatty tissue while substantially preventing conduction of heat to adjacent tissue; an impedance tracking means for monitoring the impedance of the patient's tissue during the pulse length and providing information to the control means about changes in the impedance of the patient's tissue so that the control means can terminate the RF signal when a desired treatment is completed; A system comprising: Aspect 38 38. The system of claim 37, wherein the treatment electrode has an energy per pulse of about 10 J / cm. 2~about 500 J / cm 2 wherein the pulse width of the RF signal is less than about 500 milliseconds. Aspect 39 In the system described in aspect 37, the control means is further configured to adjust the RF signal supplied to the multiple electrodes so that a second treatment RF signal is supplied to the multiple electrodes simultaneously, the second RF signal having a lower RF power and a longer pulse width than the treatment RF signal for selectively heating the septum. Aspect 40 38. The system of claim 37, wherein the second treatment RF signal is configured to at least one of reduce skin laxity and induce lipolysis. Aspect 41 41. The system of claim 40, wherein each electrode receiving the second treatment RF signal has a power of about 1 W / cm 2 ~about 5 W / cm 2 and wherein the pulse width of the RF signals is greater than about 1 second. Aspect 42 1. A system for treating the skin of a patient, comprising: A source of RF energy; a treatment applicator including a plurality of treatment electrodes configured to be placed in contact with a tissue surface, the tissue surface being a surface of a patient's tissue, and configured to deliver RF energy to the tissue surface, the plurality of treatment electrodes including at least two individually addressable treatment electrodes to which a treatment RF signal can be applied; at least one return electrode; a cooling mechanism for cooling the tissue surface in contact with the plurality of electrodes; a control means configured to sequentially supply treatment RF signals to the at least two individually addressable treatment electrodes such that each of the at least two individually addressable treatment electrodes selectively heats a septum in the fatty tissue while substantially preventing conduction of heat to adjacent tissue; A system comprising: Aspect 43 43. The system of claim 42, wherein each of the at least two individually addressable treatment electrodes has an energy of about 10 J / cm 2 ~about 500 J / cm 2 wherein the pulse width of the RF signal is less than about 100 milliseconds. Aspect 44 In the system described in aspect 42, the control means is further configured to adjust the RF signal supplied to the multiple electrodes so that a second treatment RF signal is simultaneously supplied to the multiple electrodes, the second RF signal having a lower RF power and a longer pulse width than the treatment RF signal for selectively heating the septum. Aspect 45 In the system described in aspect 42, the second treatment RF signal is configured to at least one of reduce skin laxity and induce lipolysis. Aspect 46 46. ​​The system of claim 45, wherein each electrode receiving the second treatment RF signal has a power of about 1 W / cm 2 ~about 5 W / cm 2 and wherein the pulse width of the RF signals is greater than about 1 second. Aspect 47 1. A device for treating a female urogenital condition, comprising: a probe adapted for vaginal insertion having a distal end configured to apply heat to at least a portion of a vaginal wall surface; a plurality of radio frequency (RF) energy emitting therapeutic electrodes arranged in an array at the distal end of the probe to heat tissue in contact with or adjacent to the probe; at least one temperature sensor further incorporated into the probe to monitor the temperature of the vaginal wall surface and / or the target tissue; An apparatus comprising: Aspect 48 48. The device of claim 47, wherein the temperature sensor is an infrared (IR) sensor configured to detect blackbody radiation emitted by heated tissue. Aspect 49 48. The device of claim 47, wherein the temperature sensor is implemented by one or more of the electrodes operating as impedance measuring electrodes. Aspect 50 48. The device of claim 47, wherein the electrodes are programmable to enable some of the elements of the array to be energized to deliver heat in a particular pattern. Aspect 51 48. The device of claim 47, wherein the probe further comprises at least one cooling circuit to prevent overheating of the vaginal wall surface. Aspect 52 48. The apparatus of embodiment 47, further comprising: at least one return electrode to provide a return path for RF current from said therapeutic electrode; An apparatus comprising: Aspect 53 53. The device of claim 52, wherein the return electrode is a paddle adapted to contact the patient's skin. Aspect 54 53. The device of claim 52, wherein the return electrode is provided on a urinary catheter. Aspect 55 The device of embodiment 47, wherein a return electrode is realized by one or more electrodes in the array functioning as a ground electrode. Aspect 56 48. The apparatus of embodiment 47, further comprising: a fixation device for holding the probe in place once inserted into the patient; An apparatus comprising: Aspect 57 The device of embodiment 56, wherein the fixation device comprises a locking sleeve or balloon. Aspect 58 1. A method of treating stress urinary incontinence (SUI), comprising: delivering a controlled amount of heat to a vaginal wall surface to reshape tissue in a target area near the patient's bladder neck or urethra; A method comprising: Aspect 59 A method according to embodiment 58, wherein heating is achieved by energizing at least one radio frequency (RF) energy emitting therapeutic electrode in contact with the vaginal wall surface to deliver RF current to the target area. Aspect 60 60. The method of claim 59, wherein the therapeutic electrodes comprise an electrode array carried by a probe, the method further comprising: inserting the probe into the patient such that at least one therapeutic electrode contacts at least a portion of a vaginal wall surface; A method comprising: Aspect 61 The method of embodiment 58, further comprising: Varying the power delivered by individual electrodes in the array to ensure uniform heating of tissue in the target area; A method comprising: Aspect 62 59. The method of claim 58, wherein the electrode contacts at least a portion of the anterior vaginal wall. Aspect 63 The method of embodiment 58, further comprising: delivering RF energy to heat tissue between the patient's vaginal wall surface and the urethra; A method comprising: Aspect 64 The method of embodiment 58, further comprising: delivering RF energy to heat tissue in a target area extending beyond the vaginal wall surface to a treatment depth of about 2-9 cm, preferably about 5-8 cm; A method comprising: Aspect 65 The method of embodiment 58, further comprising: delivering RF energy to heat tissue in the target area for a period of time, preferably less than 30 minutes or less than 10 minutes, and in some cases less than 5 minutes; A method comprising: Aspect 66 59. The method of claim 58, wherein the target tissue is heated to about 40-45°C or about 41-43°C. Aspect 67 The method of embodiment 58, further comprising: Mapping the heating effect of the RF electrodes by thermal imaging or impedance measurements; A method comprising: Aspect 68 The method of embodiment 58, further comprising: cooling the vaginal wall surface before, after or during heating of the tissue in the target area; A method comprising: Aspect 69 1. A system for treating tissue of a patient, comprising: A source of RF energy; a treatment applicator including a treatment electrode configured to be placed in contact with a tissue surface, the tissue surface being a surface of the patient's tissue, and to deliver RF energy to the tissue surface; at least one return electrode; a control means configured to apply an RF signal to the treatment electrode; wherein a pulse length of the RF signal and a dimension of the treatment electrode are set to apply a current density sufficient to ablate the surface of the tissue in contact with the treatment electrode. Aspect 70 70. The system of embodiment 69, further comprising: a cooling mechanism for cooling the tissue surface in contact with the electrode; A system comprising: Aspect 71 70. The system of claim 69, wherein the pulse length is less than about 100 milliseconds. Aspect 72 70. The system of claim 69, wherein the pulse length is within the range of about 5 milliseconds to about 35 milliseconds. Aspect 73 70. The system of claim 69, wherein the electrodes have dimensions in the range of about 0.1 mm to about 10 mm, or about 0.1 mm to about 5 mm. Aspect 74 70. The system of embodiment 69, further comprising: a second treatment electrode proximate the treatment electrode; wherein the control means is configured to supply the RF signal to the second treatment electrode, and a pulse length of the RF signal and a dimension of the second treatment electrode are set to apply a current density sufficient to ablate the surface of the tissue in contact with the treatment electrode. Aspect 75 In the system described in aspect 74, the pitch between the treatment electrode and the second electrode is within the range of about 0.1 mm to about 10 mm, or about 0.5 mm to about 5 mm. Aspect 76 75. The system of claim 74, wherein the treatment electrode is addressed simultaneously with the second treatment electrode by the control means. Aspect 77 In the system described in aspect 69, the treatment electrode has a cluster of at least two electrodes, and each of the electrodes in the cluster has a dimension within the range of about 0.1 mm to about 10 mm, or about 0.1 mm to about 5 mm. Aspect 78 In the system described in aspect 77, the dimensions of each of the at least two electrodes in the cluster are set to apply a current density sufficient to remove the surface of the tissue in contact with each treatment electrode of that cluster. Aspect 79 78. The system of embodiment 77, further comprising: a second cluster of at least two electrodes; wherein the control means is configured to supply the RF signal to the second cluster, and a pulse length of the RF signal and a size of each of the at least two electrodes in the second cluster are set to apply a current density sufficient to ablate the surface of the tissue in contact with each treatment electrode of the second cluster. Aspect 80 78. The system of claim 77, wherein the control means addresses the cluster and the second cluster separately. Aspect 81 1. A system for treating tissue of a patient, comprising: at least two treatment applicators each configured to be placed on a tissue surface; at least two independently controllable RF energy sources; each of the individually controllable RF energy sources operates at the same fundamental frequency while a phase and amplitude of each of the at least two RF energy sources is relatively controllable, each of the at least two treatment applicators having an individually controllable RF energy source that allows current sharing between the at least two treatment applicators to enable the at least two applicators to be positioned at two or more separate treatment areas of a subject's body, each of the at least two applicators capable of delivering an appropriate amount of RF energy to each of the separate treatment areas. Aspect 82 82. The system of embodiment 81, further comprising: Return electrode, A system comprising: Aspect 83 In the system described in aspect 81, each of the treatment applicators includes a plurality of treatment electrodes configured to be placed in contact with a tissue surface that is a surface of a patient's tissue and to deliver RF energy to the tissue surface, the plurality of treatment electrodes having at least two individually addressable treatment electrodes to which an RF signal can be applied.

Claims

1. 1. A system for treating tissue of a patient, comprising: A source of RF energy; and a first non-invasive treatment applicator including a first plurality of non-invasive treatment electrodes configured to be placed in contact with a tissue surface, the tissue surface being a surface of a patient's tissue, and configured to deliver RF energy to the tissue surface, the first plurality of non-invasive treatment electrodes having at least two individually addressable treatment electrodes to which different RF signals can be applied; at least one return electrode; a cooling mechanism for cooling the tissue surface in contact with the plurality of electrodes; control means configured to supply one or more RF signals to the first plurality of non-invasive treatment electrodes; Equipped with the one or more RF signals have a pulse length, an energy density, a duty cycle, a phase, and a power; the one or more RF signals are configured to propagate through a relatively low impedance path through a plurality of septa that penetrate a fat layer; A system in which the one or more RF signals selectively heat septa in cellulite while substantially preventing conduction of heat to nearby tissue, and the pulse length is in the range of about 5 milliseconds to about 35 milliseconds, wherein the one or more RF signals simultaneously applied to the at least two individually addressable treatment electrodes have different powers, and the control means is configured to adjust the power of the one or more RF signals indicative of a change in impedance.

2. The system of claim 1 , wherein the tissue surface of the patient comprises a surface of the skin.

3. The system of claim 1 , wherein the tissue surface of the patient comprises a mucosal tissue surface.

4. 4. The system of claim 1, wherein the at least one return electrode is positioned on the surface of the skin.

5. 5. A system according to claim 1, wherein the one or more RF signals have different pulse widths.

6. 6. A system according to claim 1, wherein the one or more RF signals have different duty cycles.

7. 7. A system according to any preceding claim, wherein the one or more RF signals have different RF frequencies.

8. 8. A system according to any preceding claim, wherein the one or more RF signals comprise RF signals of different phases.

9. 2. The system of claim 1, the at least two individually addressable treatment electrodes include at least two groups of individually addressable treatment electrodes; each treatment electrode in each group of individually addressable treatment electrodes has an RF signal simultaneously applied to it that is the same as the other treatment electrodes in that group; A system in which each group of individually addressable treatment electrodes is configured such that the RF signal applied simultaneously to each group is distinct from the others.

10. 2. The system of claim 1, wherein a second non-invasive treatment applicator configured to be placed in contact with the tissue surface of the patient remote from the first non-invasive treatment applicator includes the at least one return electrode.

11. 11. The system of claim 10, wherein the second non-invasive treatment applicator includes a second plurality of non-invasive treatment electrodes configured to be placed in contact with a tissue surface that is a surface of the tissue of a patient and to deliver RF energy to the tissue surface, the second plurality of non-invasive treatment electrodes having at least two individually addressable treatment electrodes to which different RF signals can be applied.

12. 12. The system of claim 11, wherein the control means is configured to energize only one of the individually addressable treatment electrodes in each of the first and second non-invasive treatment applicators at a given time.

13. 13. The system of claim 11 or 12, wherein the control means is configured to measure impedance between each of the at least two individually addressable treatment electrodes on the first non-invasive treatment applicator and each of the at least two individually addressable treatment electrodes on the second non-invasive treatment applicator.

14. 14. The system of claim 13, wherein the control means is configured to measure impedance between each of the at least two individually addressable treatment electrodes of the first non-invasive treatment applicator and each of the at least two individually addressable treatment electrodes of the second non-invasive treatment applicator by generating a sub-treatment threshold RF current therebetween prior to applying one or more RF signals to the first plurality of electrodes.

15. 14. The system of claim 13, wherein the control means is configured to measure impedance between each of the at least two individually addressable treatment electrodes on the first non-invasive treatment applicator and each of the at least two individually addressable treatment electrodes on the second non-invasive treatment applicator while applying one or more RF signals to the first plurality of electrodes to determine when to stop the treatment RF signal and terminate treatment.

16. 16. The system of claim 10, wherein the second non-invasive treatment applicator includes a cooling mechanism for cooling the tissue surface of the patient in contact with the multiple electrodes of the second non-invasive treatment applicator.

17. 10. The system of claim 1, wherein the return electrode is a passive electrode configured to be placed in contact with the tissue surface of a patient remote from the first non-invasive treatment applicator.

18. 20. The system of claim 17, wherein the passive electrode comprises a drain pad.

19. The system according to claim 17 or 18, further comprising: A system comprising: a second non-invasive treatment applicator configured to be placed in contact with a tissue surface of a patient remote from the tissue surface on which the first non-invasive treatment applicator is placed and the tissue surface on which the passive electrode is placed, the second non-invasive treatment applicator including a second plurality of non-invasive treatment electrodes configured to be placed in contact with a tissue surface that is a surface of the patient's tissue and to deliver RF energy to the tissue surface.

20. 20. The system of claim 1, wherein the control means is configured to individually poll each of the at least two individually addressable treatment electrodes with a low power, sub-treatment threshold RF signal.

21. 21. The system of any one of claims 1 to 20, wherein the one or more RF signals are configured to reduce skin laxity by stimulating collagen production.

22. 21. The system of any one of claims 1 to 20, wherein the one or more RF signals are configured to reduce the appearance of cellulite.

23. 23. The system of claim 22, wherein each electrode has an energy per pulse of about 10 J / cm 2 ~Approx. 1000 J / cm 2 wherein the pulse width of the one or more RF signals is less than about 500 milliseconds.

24. 21. The system of any one of claims 1 to 20, wherein the one or more RF signals are configured to induce lipolysis of adipose tissue underlying the tissue surface.

25. 25. The system of claim 24, wherein each electrode has a power of about 1 W / cm 2 ~Approx. 5 W / cm 2 wherein the one or more RF signals have a pulse width greater than about 1 second.

26. 26. The system of any one of claims 1 to 25, wherein the cooling mechanism comprises a circulating fluid.

27. 27. The system of claim 26, wherein the temperature of the circulating fluid is controlled by a temperature regulation means such that a target tissue region located beneath the tissue surface is maintained at a temperature within the range of about 42°C to about 47°C for a treatment time within the range of about 10 minutes to about 30 minutes.

28. 28. The system of claim 26 or 27, wherein the circulating fluid is water.

29. 29. The system of any one of claims 26 to 28, wherein at least a portion of the fluid path of the circulating fluid is in thermal contact with a side of the electrode that is not configured to contact the tissue surface.

30. 29. The system of any one of claims 26 to 28, wherein at least a portion of the fluid path of the circulating fluid is in thermal contact with the tissue surface at locations between adjacent electrodes of the plurality of non-invasive treatment electrodes.

31. 31. The system of any one of claims 1 to 30, wherein the cooling mechanism includes one of a thermoelectric element and a phase change material positioned in thermal contact with the electrode in the first non-invasive treatment applicator.

32. 32. The system of claim 1, further comprising at least one temperature detection means for detecting a temperature of the tissue surface at a periphery of the electrode array, and wherein the control means is further configured to reduce the power of the one or more RF signals applied to electrodes at a side of the first non-invasive treatment applicator that has the highest temperature.

33. 32. The system of any one of claims 1 to 31, further comprising at least one temperature detection means for detecting a temperature of the tissue surface at the periphery of the electrode array, and wherein the control means is further configured to increase the power of the one or more RF signals applied to an electrode on a side of the first non-invasive treatment applicator that is opposite to the side of the first non-invasive treatment applicator having the highest temperature.

34. 1. A system for treating tissue of a patient, comprising: A source of RF energy; and a first non-invasive treatment applicator including a first plurality of non-invasive treatment electrodes configured to be placed in contact with a tissue surface, the tissue surface being a surface of a patient's tissue, and configured to deliver RF energy to the tissue surface, the first plurality of non-invasive treatment electrodes having at least two individually addressable treatment electrodes to which different RF signals can be applied; at least one return electrode; a cooling mechanism for cooling the tissue surface in contact with the plurality of electrodes; control means configured to supply one or more RF signals to the first plurality of non-invasive treatment electrodes; Equipped with the one or more RF signals have a pulse length, an energy density, a duty cycle, a phase, and a power; the one or more RF signals are configured to propagate through a relatively low impedance path through a plurality of septa that penetrate a fat layer; 11. A system comprising: a first RF signal source configured to selectively heat septa in cellulite while substantially preventing conduction of heat to nearby tissue, the first RF signal being within a range of about 5 milliseconds to about 35 milliseconds; a second RF signal source configured to selectively heat septa in cellulite while substantially preventing conduction of heat to nearby tissue, the first RF signal being within a range of about 5 milliseconds to about 35 milliseconds; a second RF signal source configured to selectively heat septa in cellulite while substantially preventing conduction of heat to nearby tissue, the first RF signal being within a range of about 5 milliseconds to about 35 milliseconds;

35. 1. A system for treating tissue of a patient, comprising: A source of RF energy; and a first non-invasive treatment applicator including a first plurality of non-invasive treatment electrodes configured to be placed in contact with a tissue surface, the tissue surface being a surface of a patient's tissue, and configured to deliver RF energy to the tissue surface, the first plurality of non-invasive treatment electrodes having at least two individually addressable treatment electrodes to which different RF signals can be applied; at least one return electrode; a cooling mechanism for cooling the tissue surface in contact with the plurality of electrodes; control means configured to supply one or more RF signals to the first plurality of non-invasive treatment electrodes; Equipped with the one or more RF signals have a pulse length, an energy density, a duty cycle, a phase, and a power; the one or more RF signals are configured to propagate through a relatively low impedance path through a plurality of septa that penetrate a fat layer; a system for detecting a relative thickness of a subcutaneous fat layer using a pulse length of about 5 milliseconds to about 35 milliseconds, the system further comprising: an impedance tracking means configured to monitor the impedance of the patient's tissue during the pulse length and detect one or more of a lower impedance or a higher impedance at one or more treatment electrodes; the control means further configured to adjust or vary the RF energy delivered by the treatment electrodes in response to an impedance value detected for the tissue underlying the treatment electrodes; the impedance tracking means configured to measure a difference in impedance values ​​between adipose tissue and muscle tissue; and a relative thickness of a subcutaneous fat layer calculated by the system using the measured difference in impedance values.

36. 36. The system of claim 35, wherein the lower and higher impedance values ​​are relative impedance measurements measured with different treatment electrodes.

37. 37. The system of claim 35 or 36, wherein the control means is configured to homogenize RF treatment relative to a target treatment zone using impedance mapping generated using measurements from the impedance tracking means.

38. 38. A system as claimed in any one of claims 35 to 37, comprising dispensing electronics in electrical communication with the control means, the dispensing electronics configured to adjust the RF signal sent to one or more electrodes in response to differences in impedance measured using the impedance tracking means.

39. 1. A system for treating the skin of a patient, comprising: A source of RF energy; and a non-invasive treatment applicator including a non-invasive treatment electrode configured to be placed in contact with a tissue surface, the tissue surface being a surface of a patient's tissue, and to deliver RF energy to the tissue surface; at least one return electrode; a cooling mechanism for cooling the tissue surface in contact with the electrode; control means configured to apply an RF signal to the treatment electrode; and an impedance tracking means configured to monitor the impedance of the patient's tissue during the pulse length to detect a change in one or more impedance values ​​of a partition of the tissue region; the RF signal has a pulse length, energy density, and power to selectively heat septa in cellulite while substantially preventing conduction of heat to nearby tissue; the RF signal propagates through a relatively low impedance path through a septum penetrating a fat layer, the pulse length being within a range of about 5 milliseconds to about 35 milliseconds; the control means is further configured to deliver RF energy to treat the tissue region; The impedance tracking means is configured to monitor the impedance of a tissue region to track changes in tissue composition of the tissue region.

40. 40. The system of claim 39, wherein the treatment electrode has an energy per pulse of about 10 J / cm 2 ~Approx. 500 J / cm 2 wherein the pulse width of the RF signal is less than about 500 milliseconds.

41. 41. The system of claim 39 or 40, further comprising a plurality of electrodes, one of which is a non-invasive treatment electrode, and the control means is further adapted to adjust the RF signals supplied to the plurality of electrodes such that a second treatment RF signal is simultaneously supplied to the plurality of electrodes, the second RF signal having a lower RF power and a longer pulse width than the treatment RF signal for selectively heating the septum.

42. 42. The system of claim 41, wherein the second treatment RF signal is configured to at least one of reduce skin laxity and induce lipolysis.

43. 43. The system of claim 41 or 42, wherein each electrode receiving the second treatment RF signal has a power of about 1 W / cm 2 ~Approx. 5 W / cm 2 and wherein the pulse width of the RF signals is greater than about 1 second.

44. 44. The system of any one of claims 39 to 43, wherein the change in tissue composition in the tissue region corresponds to treatment of a septum.

45. 45. The system of any one of claims 39 to 44, wherein the impedance tracking means is further configured to detect impedance values ​​of a target treatment zone and to compensate for differences in impedance values ​​based on an impedance mapping of the target treatment zone by controlling RF power delivered through individual electrodes.

46. 46. ​​The system of any one of claims 39 to 45, wherein the control means is further configured to direct all of the RF energy available to the non-invasive treatment electrodes to preferentially heat the septum.

47. 47. The system of any one of claims 39 to 46, wherein the energy density per pulse is about 500 J / cm per pulse. 2 ~Approx. 1000 J / cm 2 Within the scope of the system.

48. 48. The system of any one of claims 1-47, wherein the RF signal is adjusted or varied to bring the impedance value closer to and maintain it at a target value, and in response delivers RF energy sufficient to coagulate the plurality of septa.

49. 48. The system of any one of claims 1-47, wherein the RF signal is adjusted or varied to bring the impedance value closer to and maintain it at a target value, and in response delivers sufficient RF energy to heat the plurality of septa.

50. 48. The system of any one of claims 1-47, wherein the RF signal is adjusted or varied to bring the impedance value closer to and maintain it at a target value, and in response delivers sufficient RF energy to rupture the plurality of septa.

51. 1. A system for treating tissue of a patient, comprising: A source of RF energy; and a first non-invasive treatment applicator including a first plurality of non-invasive treatment electrodes configured to be placed in contact with a tissue surface, the tissue surface being a surface of a patient's tissue, and configured to deliver RF energy to the tissue surface, the first plurality of non-invasive treatment electrodes having at least two individually addressable treatment electrodes to which different RF signals can be applied; at least one return electrode; a cooling mechanism for cooling the tissue surface in contact with the plurality of electrodes; control means configured to supply one or more RF signals to the first plurality of non-invasive treatment electrodes; Equipped with the one or more RF signals have a pulse length, an energy density, a duty cycle, a phase, and a power; the one or more RF signals are configured to propagate through a relatively low impedance path through a plurality of septa that penetrate a fat layer; A system in which the one or more RF signals selectively heat septa in cellulite while substantially preventing conduction of heat to nearby tissue, and the pulse length is in the range of about 5 milliseconds to about 35 milliseconds, wherein the control means is configured to adjust the increase or decrease in RF power delivered to the treatment zone in proportion to the difference in electrode impedance.

52. 52. The system of any one of claims 1 to 51, wherein the energy density per pulse is about 500 J / cm per pulse. 2 ~Approx. 1000 J / cm 2 Within the scope of the system.

53. 53. The system of any one of claims 1-52, wherein the applicator is configured for direct attachment to the tissue surface of a patient by suction.

54. 54. The system of any one of claims 1 to 53, wherein the applicator is a hand piece comprising the first plurality of non-invasive treatment electrodes, the first plurality of non-invasive treatment electrodes configured to operate in a stamping fashion.

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