WO2023283118A1

WO2023283118A1 - Flexible applicators

Info

Publication number: WO2023283118A1
Application number: PCT/US2022/035907
Authority: WO
Inventors: Daniel B. MASSE; James Boll; Jeffrey Simon; David SONNENSHEIN; Samuel Bruce; Oscar Daniel AYALA
Original assignee: Cynosure, Llc
Priority date: 2021-07-08
Filing date: 2022-07-01
Publication date: 2023-01-12

Abstract

In part the disclosure relates to a radiofrequency (RF)-based treatment system. The system may include a first flexible applicator that includes a plurality of layers, a hub region comprising one or more electrical connector contact regions, one or more RF delivery regions, and a first electrical connection comprising a conductive material; and a second flexible applicator comprising the plurality of layers, and one or more RF delivery regions, wherein the second flexible applicator is in electrical communication with the first electrical connection.

Description

FLEXIBLE APPLICATORS

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63/219,711, filed July 8, 2021, the disclosure of which is herein incorporated by reference in its entirety.

FIELD

[0001] The present disclosure relates generally to systems and methods for treating a patient’s skin (e.g., dermis and hypodermis) and other target tissue, including tissue at a depth below a tissue surface with radiofrequency (RF) energy.

BACKGROUND

[0002] Electrosurgical devices are known for applying RF energy to tissue so as to generate a variety of effects, including invasive procedures (e.g., for ablating or vaporizing tissue) or less- invasive procedures (e.g., to gently heat the surface of the skin). However, a need remains for improved methods and system for providing uniform and large-area application of RF energy in cosmetic and/or aesthetic applications, for example, in order to improve the appearance of skin so that it is (or appears) tightened/smoothed and/or to reduce fat present in subcutaneous tissue (e.g., hypodermis). The present disclosure addresses this need and others.

SUMMARY

[0003] Systems and methods utilizing RF energy to treat a patient’s skin (e.g., dermis and hypodermis) or other target tissue at a depth below a tissue surface with RF energy are described herein. In various aspects, the present teachings can provide a non-invasive, cooled (or uncooled) RF-based treatment to achieve one or more of body sculpting (lipolysis), skin tightening (laxity improvement), cellulite treatment apparatus, vaginal laxity treatment or rejuvenation, urinary incontinence treatment, fecal incontinence treatment, and treatment of other genitourinary conditions, by way of non-limiting examples.

[0004] In accordance with various aspects of the present teachings, a radiofrequency (RF)-based treatment system includes a flexible applicator that includes a plurality of layers, the plurality of layers that includes a first dielectric layer, a second dielectric layer, and a conductive layer, wherein the first dielectric layer and the second dielectric layer sandwich the conductive layer, the plurality of layers define a plurality of kerfs, and an inner region and N regions extending from the inner region, wherein the plurality of kerfs divide the applicator into N regions.

[0005] In some aspects, N ranges from 2 to 12. Optionally, some aspects, the plurality of layers define one or more strain relief elements, wherein each strain relief element is a circular or elliptical hole in the plurality of layers. Optionally, in some aspects, one or more of the plurality of kerfs terminate at one or more strain relief elements, wherein the inner region is adjacent the one or more strain relief elements. Optionally, in some aspects, the inner region is a kerf-free region, wherein N is 6. Optionally, in some aspects, the plurality of N regions include a first region and a second region, wherein each of the first and second region define one or more areas, borders, or kerfs that are substantially the same.

[0006] In some aspects, the plurality of layers includes a label, wherein the label includes N region identifiers, wherein each of the N region identifiers is disposed on one of the N regions. Optionally, in some aspects, the applicator defines an applicator shape, wherein applicator shape is selected from the group consisting of elliptical, circular, substantially elliptical, substantially circular, pear shaped, substantially pear shaped, submental, and combinations thereof. Optionally, in some aspects, the conductive layer includes a patterned region of copper traces in each of the N regions, wherein each of the patterned regions has one or more copper traces in electrical communication with copper traces arranged along the inner region. Optionally, in some aspects, the applicator further includes an electrical connector, the electrical connector in electrical communication with one or more addressable regions of conductive layer.

[0007] In some aspects, the system includes an RF treatment system comprising an RF generator, the RF generator having an operating frequency that ranges from about 0.5 MHz to about 10 MHz, wherein the RF generator is in electrical communication with the electrical connector. Optionally, in some aspects, the applicator further includes an electrical connector, the electrical connector in electrical communication with one or more addressable regions of conductive layer, the electrical connector comprising a plurality of electrical contacts, wherein the copper traces arranged along the inner region are in electrical communication with the electrical contacts. Optionally, in some aspects, the copper traces arranged along the inner region are arranged in a series of three or more adjacent sections that increase in width in direction towards the electrical connector. Optionally, in some aspects, the conductive layer includes a continuous copper sheet and wherein each of the N regions further includes a first region of dielectric material having a first thickness and a first area, and a second region of dielectric material having a second thickness and a second area, wherein area of each region is greater than first area disposed therein, wherein each first area is greater than each second area.

[0008] In some aspects, the system includes an RF treatment system comprising an interface device in communication with the RF treatment system, the interface device comprising a clamp and a cable adapter, wherein the clamp opens and closes to releasably connect and align with electrical connector, wherein cable adapter is in electrical communication with electric contacts of clamp. Optionally, in some aspects, the area of electrode ranges from about 50 cm² to about 600 cm². Optionally, in some aspects, the system includes a heat shield layer, wherein conductive layer includes arrangements of electrical traces, wherein heat shield layer covers a portion of inner region below which adjacent electrical traces span the portion and change in density along the portion. Optionally, in some aspects, the system includes one or more temperature sensors per each of the N regions.

[0009] In some aspects, the system includes an RF treatment system in electrical communication with the applicator and each temperature sensor, further comprising a control system, wherein control system selectively addresses each of the N regions to transmit RF energy sequentially to facilitate uniform heating according to one or more patterns. Optionally, in some aspects, the system includes an RF treatment system in electrical communication with the applicator and each temperature sensor, further comprising a control system, wherein control system selectively bypasses one or more of the N regions in response to an operator selection that the one or more N regions is positioned above a sensitive tissue region. Optionally, in some aspects, the plurality of layers further includes one or more adhesive layers, a polyamide layer, and an aqueous gel layer.

[0010] In accordance with various aspects of the present teachings, a method of treating tissue using an RF -based applicator includes providing a flexible applicator comprising an elongate inner spine region and a plurality of regions extending therefrom, wherein each of the plurality of regions is bounded by a first kerf and a second kerf; and transmitting RF energy from each of the plurality of regions according to an alternating or sequential addressing schemes to raise tissue below applicator to a target temperature during an initial heating time period. Optionally, in some aspects, the method includes shielding the inner spine region to avoid unwanted heating of target tissue below inner spine region of applicator. Optionally, in some aspects, the method includes controlling transmission of RF energy such that one or more sensitive regions below one or more of the plurality of regions are not interrogated with RF energy. In one embodiment, the method includes controlling transmission of RF energy such that one or more sensitive regions below one or more of the plurality of regions is cosmetically treated to increase or initiate lipolysis, skin tightening, and cellulite reduction. The method may be performed over a treatment time that ranges from about 10 to about 15 minutes.

Applicator Features and Embodiments

[0011] In part the disclosure relates to a radiofrequency (RF)-based treatment system. The system may include a first flexible applicator that includes a plurality of layers, a hub region comprising one or more electrical connector contact regions, one or more RF delivery regions, and a first electrical connection comprising a conductive material; and a second flexible applicator comprising the plurality of layers, and one or more RF delivery regions, wherein the second flexible applicator is in electrical communication with the first electrical connection.

[0012] In one embodiment, the first flexible applicator further comprises a second electrical connection comprising the conductive material. In one embodiment, the system further includes a third flexible applicator that includes the plurality of layers, and one or more RF delivery regions, wherein the third flexible applicator is in electrical communication with the second electrical connection. In one embodiment, the first applicator is a submental applicator. In one embodiment, the first electrical connection and the second electrical connection are flexible ribbons comprising the layers. In one embodiment, the second flexible applicator extends from the first electrical connection. In one embodiment, the third flexible applicator extends from the second electrical connection.

[0013] In one embodiment, the plurality of layers includes a first dielectric layer, a second dielectric layer, and a conductive layer, wherein the first dielectric layer and the second dielectric layer sandwich the conductive layer. In one embodiment, the conductive layers defines one or more conductive trace patterns, each conductive trace pattern is positioned above one or more RF delivery regions. In one embodiment, the plurality of layers further includes one or more adhesive layers, a polyamide layer, and an aqueous gel layer. In one embodiment, each applicator defines an applicator shape, wherein applicator shape is selected from the group consisting of elliptical, circular, substantially elliptical, triangular, rectangular, substantially circular, pear shaped, substantially pear shaped, submental, and combinations thereof.

[0014] In one embodiment, the system further includes an RF treatment system comprising an RF generator, the RF generator having an operating frequency that ranges from about 0.5 MHz to about 10 MHz, wherein the RF generator is in electrical communication with the electrical connector. In one embodiment, the applicator further includes an electrical connector, the electrical connector in electrical communication with one or more addressable regions of conductive layer, the electrical connector comprising a plurality of electrical contacts, wherein the copper traces arranged along the inner region are in electrical communication with the electrical contacts. In one embodiment, the copper traces arranged along the inner region are arranged in a series of triangular or rectangular regions.

[0015] In one embodiment, the system further includes one or more temperature sensors per each RF delivery region, wherein the temperature sensor are in electrical communication with one or more conductive electrical contacts positioned in the elongate hub region. In one embodiment, the system further includes an RF treatment system comprising an interface device in communication with the RF treatment system, the interface device comprising a clamp and a cable adapter, wherein the clamp opens and closes to releasably connect and align with electrical connector, wherein cable adapter is in electrical communication with electric contacts of clamp. In one embodiment, the area of RF delivery region ranges from about 50 cm² to about 600 cm².

[0016] In one embodiment, the system further includes an RF treatment system in electrical communication with the applicator and each temperature sensor, further comprising a control system, wherein control system selectively addresses on or more of the applicators to transmit RF energy. In one embodiment, one or more temperature sensors a disposed between one or more layers of each applicator. In one embodiment, the second applicator is sized to treat one of a cheek, a jowl, a forehead, chest, or a decolletage. In one embodiment, the first applicator is sized to treat an area that ranges from about 50 cm² to about 600 cm². In one embodiment, the area of RF delivery region ranges from about 600 cm² to about 1200 cm.

[0017] In one embodiment, the first applicator is sized to treat all or a portion of an abdomen, a thigh, an arm, or a buttocks. In one embodiment, the second applicator is sized to treat all or a portion of an abdomen, a thigh, an arm, or a buttocks. In one embodiment, the second applicator is sized to treat all or a portion of a submental area, a cheek, a jowl, a forehead, chest, or a decolletage. In one embodiment, the plurality of layers in one or both applicators define a plurality of kerfs, and an inner region and N regions extending from the inner region, wherein the plurality of kerfs divide the applicator into N regions.

[0018] Although, the disclosure relates to different aspects and embodiments, it is understood that the different aspects and embodiments disclosed herein can be integrated, combined, or used together as a combination system, or in part, as separate components, devices, and systems, as appropriate. Thus, each embodiment disclosed herein can be incorporated in each of the aspects to varying degrees as appropriate for a given implementation. Further, the various systems, probes, multilayer linked applicators, applicators, controllers, components and parts of the foregoing can be used with any suitable tissue surface, cosmetic applications, and medical applications and other methods and conjunction with other devices and systems without limitation.

[0019] These and other features of the applicant’s teachings are set forth herein.

BRIEF DESCRIPTION OF THE FIGURES

[0020] Fig 1A is a schematic diagram showing a group of applicators that include a larger applicator and several small applicators suitable for application to various treatment regions according to an illustrative embodiment of the disclosure.

[0021] Fig IB is a schematic diagram showing a group of applicators that include several applicators that are roughly the same size and suitable for application to various treatment regions according to an illustrative embodiment of the disclosure.

[0022] Fig 2A is a schematic diagram showing a group of applicators including an exemplary design of one or more submental applicators with one or more electrical connections extending from the first applicator according to an illustrative embodiment of the disclosure.

[0023] Fig 2B is a schematic diagram showing a group of applicators including an exemplary design of one or more submental applicators with one or more electrical connections extending from a spine or hub region according to an illustrative embodiment of the disclosure. [0024] Fig. 3 is an image of an exemplary design of flexible applicator assembly according to an illustrative embodiment of the disclosure.

[0025] Figs. 4, 5 A, 5B, and 6A and 6B are images of a test subject having various applicators applied to different treatment regions relative to the head and neck according to an illustrative embodiment of the disclosure.

DETAILED DESCRIPTION

[0026] The systems and methods described herein support the use of radiofrequency (RF) to deliver energy and treat the skin surface and deeper tissue structures such as the dermis and subcutaneous fat. Various electrode designs, such as flexible applicators may be used to deliver RF energy. In various embodiments, different applicator designs are disclosed that include a hub and one or more spokes. Other configurations, such a finger and hand geometry, with one larger applicator and other narrow applicators extending therefrom are also possible. Various tree-like configurations may be used with central trunks and various electrodes branching off to different applicators.

[0027] In some embodiments, the hub and each spoke arrangement may be of various sizes and shapes and are flexible in various embodiments. In some embodiments, one or more of the applicators are sized to treat a submental region of a patient. The hub and spoke design and other applicator assembly designs support multiple RF applicators that can be used to treat different regions simultaneously or during differing treatment periods by selectively controlling when a given applicator in the set of applicators is energized. The various applicators are all connected or linked in a continuous deformable sheet in some embodiments. In some embodiments, the applicators are linked by thin flexible ribbons. Additional supporting details relating to some of the components, control system, and other details may be found in Exhibit A.

[0028] Fig 1 A is a schematic diagram showing an applicator assembly 10 that includes group of applicators that include a relatively large applicator 15 and several relatively small applicators 20 suitable for application to various treatment regions. In some embodiments, the various applicators may be of different shapes and sizes and cover different area measurements. Fig IB is a schematic diagram showing an applicator assembly 12 that includes group of applicators 22 that include several applicators that are roughly the same size and suitable for application to various treatment regions. The various related components included in the embodiments of Fig. 1A and IB are discussed herewith below. In various embodiments, some or all of the applicators are flexible and formed from a set of common layers before being cut to a particular shape to form a given applicator assembly.

[0029] Each of the applicators may have one or more RF delivery regions 25. A given applicator includes multiple layers with one layer include conductive traces suitable for directing received electrical signals from an RF treatment system and delivery RF energy via region 25. Each applicator may be in electrical communication with an electrical connector 40 that interfaces with the RF treatment system. In various embodiments, electrical tracings or other electrical connections such as wires, thin flexible conductive traces, and other conductors may be used as an electrical applicator lead or connection 30. In various embodiments, the electrical applicator connection 30 may be a switchback. In various embodiments, a switchback may include one or more electrical connectors from central hub part of applicator that extend to various other RF zones of other applicators.

[0030] In some embodiments, one of the electrodes operates as a hub electrode with other electrodes being spoke electrode that are in electrical communication with hub electrode, or a portion of the hub electrode, or to an electrical connector or spine in electrical communication with the hub electrode. In some embodiments, the applicators 20 that extend from main larger applicator 15 can be applied on various body areas to cover a larger total treatment area. In some embodiments, the various applicators of a given applicator assembly may have different sizes and shapes.

[0031] In one exemplary embodiment, the main larger applicator 15 is a flexible applicator that includes a plurality of layers, the plurality of layers that includes a first dielectric layer, a second dielectric layer, and a conductive layer, wherein the first dielectric layer and the second dielectric layer sandwich the conductive layer, the plurality of layers define a plurality of kerfs, and an inner region and N regions extending from the inner region, wherein the plurality of kerfs divide the applicator into N regions where N is 6. Suitable applicators that may be employed in place of those described in FIGS. 1A and IB are described in further detail in accordance with U.S. Publication No. 20200352633 entitled “NON-INVASIVE, UNIFORM AND NON-UNIFORM RF METHODS AND SYSTEMS RELATED APPLICATIONS”, the entire disclosure of which is hereby incorporated by reference in its entirety.

[0032] In some embodiments, referring to Figs. 1 A and IB, a given applicator such as applicator 15 may include a spine or hub portion 33. In some embodiments, the spine or hub portion is thicker than other regions of the applicator and may include a different arrangement of layers. In some embodiments, the spine or hub region includes a wider or tapered section relative to other portions of the application. In various embodiments, the spine or hub portion may terminate at an electrical terminus 37. This electrical terminus may include one or more exposed electrical contacts or connection conductive regions suitable for connecting, coupling, or otherwise mating with an electrical connector in electrical communication with RF delivery system. The electrical connector 40 may include a mechanical grip such as spring clip or other mechanism to receive and hold the electrical terminus 37.

[0033] The various applicator embodiments provide flexibility to allow for treatments in smaller areas such as regions of the face (forehead, cheeks, submental region) in some embodiments. Although, larger versions of the applicators may be used in different embodiments for stomach, thighs, back, etc. In addition, suitable applicator embodiments can address larger treatment areas and smaller treatment areas (e.g., abdomen and submental area). In general, the applicator’s tissue contacting surface may be tailored to fit target treatment area. In addition, the applicators allow for treatment of multiple large adjacent body / tissue areas (e.g. inner thigh and outer thigh) and multiple non-adjacent areas (e.g. submental and decolletage) that are connected to a single RF energy source.

[0034] In various embodiments, the applicators disclosed herein are fabricated using various substrates, dielectrics, conductive layers, adhesives, liners, and other suitable materials disclosed herein or incorporated by reference herein. In some embodiments, the lengths of the various electrical leads and associated supporting substrates that tether the individual applicators to a hub applicator can vary over a range of lengths from about 0.5 inches to about 36 inches (or longer) in some embodiments. By increasing the lengths of the electrical leads for the applicators, it is possible to treat multiple non-adjacent body areas, simultaneously using two or more applicators having thin flexible electrical connections of varying lengths. Fig 2A is a schematic diagram showing a group of applicators 53 including an exemplary design of one or more submental applicators 60 with one or more electrical connections 65a, 65b extending from the first applicator. In some embodiments, such as shown in Fig. 2A, placing two electrical connections 65a, 65b (also referred to as switchbacks) may require modification of the submental conductive traces as shown in regions 68a and 68b. Here the switchbacks 68a and 68b originate on the applicator 60 and in this embodiment the applicator acts as the hub. The regions of trace modification are shown within the dotted circles. These changes in modification of the conductive traces may be achieved by having the electrical connections that extend to the other electrodes in the group and extend from the spine 75. The spine 75 region terminates at electrical contacts 37 in some embodiments.

[0035] Fig 2B is a schematic diagram showing a group of applicators 55 including an exemplary design of one or more submental applicators 80 and two other applicators 85a, 85b. One or more electrical connections 87a, 87b are extending from a spine 88 or hub region according to an illustrative embodiment of the disclosure. As is shown in Fig. 2B, two of the electrical connections 87a, 87b extend from the hub region on the spine 88 to the second applicator 85a and third applicator 85b as shown. In some embodiments, the first applicator from which a portion of the spine or hub extends is the primary applicator. In other embodiments, the applicator that electrically couples to the hub on the spine 88 of the primary applicator is a secondary applicator, spoke applicator, satellite applicator, supplemental applicatory, or support applicator. In various embodiments, the secondary applicator has an electrical connector length sized to facilitate the secondary applicator being applied to a treatment region in close proximity or adjacent the treatment region to which applicator 80 is applied. Various thermistors T are shown in applicator embodiments of Figs. 2A and 2B. These may be used for temperature control and as inputs for performing various treatments and selective applicator addressing to delivery RF energy in response to tissue temperature changes. Temperature sensors are generally included in various applicator embodiments.

[0036] One of the benefits of using a switchback design for RF treatments is that it can increase tolerability of the treatment so as to not allow a specific region of the applicator to heat up for too long since the algorithm design will switch the next electrode region to be activated. This enables the subject to be treated in relative comfort for a length of time to enable the desired temperature in the treatment region to be achieved. The hub and switchback configuration using flexible applicator(s) can enable treatment coverage of hard-to-reach areas that may be more contoured, which ridged applicators may have more of a challenge in fully making contact with the skin surface for a particular RF treatment. Further, treatment areas that are nice to address, but are not a main area of concern for treatment, can be addressed under this configuration, which maximizes treatment coverage for the patient, but avoids additional treatment sessions and the costs associated therewith. Additionally, the hub and switchback configuration can enable one or more adjacent and/or non-adjacent body areas to be treated in a single treatment session. In this way, a single applicator can, in some embodiments, treat several areas of interest to a patient and thereby provide a more complete body treatment in a single session than would be possible with a single applicator.

[0037] Figure 3 shows an applicator assembly 85. The assembly 85 includes a terminal region 90 that is connectable to the RF delivery system. An elongate spine 95 that extends from the terminal region 90 includes a hub region. In turn, moving along the length of spine 95, electrical connectors or switchbacks 110, 115 extend, in the hub region, from either side of the spine 95 which extends to a first or primary applicator 100. In some embodiments, applicator 100 is a submental applicator. Each of the electrical connections 110, 115 extend to two additional applicators, respectively. These two additional applicators are shown as a second applicator 120 and a third applicator 125. In various embodiments, each applicator has a tissue facing or contacting surface. In various embodiments, all of the applicators include RF delivery zones on the tissue facing or surface contacting side. The terminal region 90 may connect or couple to an electrical connector. In various embodiments, a clamp or clip-based electrical connector 150 as shown in Figs. 4, 5A, 5B, and 6A and 6B.

[0038] Figs. 4, 5 A, 5B, and 6A and 6B are images of a test subject having various applicators of assembly 85 applied to different treatment regions relative to the head and neck according to an illustrative embodiment of the disclosure. As shown, applicator 100 is applied under the chin to the submental region. The other applicators, applicators 125, 120 may be applied on forehead as shown in Figs. 5A and 5B. The applicators are connected to an electrical system or RF system by connector 150. In Figs 6A and 6B, the applicators 120, 125 are applied to cheeks while applicator 100 is under the chin in contact with the submental region. In addition to attaching to and making electrical contact with the terminal region 90 of the spine 95, the connector 150 can releasably attach to a garment worn by the person being treated. More specifically, the connector 150 can releasably attach to a garment worn by the patient via clip type of attachment, for example, a binder clip type of releasable attachment, a snap clip releasable attachment, or a vice clip type of releasable attachment that releasably attaches the connector 150 the patient garment. Such a releasable attachment of the connector 150 to a garment worn by the subject can relieve stress that would be otherwise experienced by the applicator system if it were only hanging off the patient as held by the adhesive.

[0039] In some embodiments an additional layer of Kapton is applied to zone traces at bottom applicator to minimize localized heat and intolerable sensation for patient during treatment. Kapton may be added under the applicator to minimize hot spots during radiofrequency (RF) delivery to various applicator regions or zones.

[0040] In some embodiments, electrical connection of trace route in specific zones enables ease of use for face zones. Various types of electrical connections may be used for different applicator types and configurations. Electrical connectors from a central hub or spine of applicator that extend to various other RF zones of the application may be used in various embodiments. The foregoing electrical connections may be switch backs in some embodiments.

[0041] In various embodiments, connections that connect face zones to tail end of applicator, such as switchbacks, do not increase in heat during treatment since there is no hydrogel applied to the switchback. This is an advantageous design feature since these connectors are exposed to the air and may make contact with the patient if the patient moves during a treatment in some embodiments. Thus, should the patient move and their skin make contact with the connections, for example, a switchback, because the connections do not increase in temperature, patient comfort is not put at risk.

[0042] The area of a specific “treatment zone” may be modified if the trace pattern is adjusted to account for positioning where a switchback is routed from one part of an applicator and connected to a specific zone. In various embodiments, the modification may be made to reduce or minimize interference from an electric field, which may lead to localized hot spots and cold spots in the “treatment zone”. In some embodiments, interference between one or more electrical components or leads of a given applicator is reduced to prevent or reduce the occurrence of applicator hots spots due to electrical heating.

[0043] Any of the given electrical connections describes and depicted herein such as those between a hub and spoke embodiment may be adjusted in length (to accommodate positioning of applicators) and width (to account for traces for additional applicators). Various sizes and electrode pattern designs for a given applicator may be customized to fit specific body areas, tissues, and organs. The various embodiments disclosed herein are not limited to the submental region and the face. For example, the embodiments described and depicted in the figures may be scaled up or down in size to increase the area of a given applicator to apply to any region of the body, without limitation. For example, the embodiment disclosed herein could be employed to treat the abdomen, thighs and/or arms of a subject.

[0044] Further, the applicators support the delivery of RF to treat contoured body areas that are challenging to treat using rigid RF delivery applicators that did not contour to the body (e.g. flanks, thighs). In addition, the disclosure relates to applicators that deliver RF energy to the submental space without the need of for headgear or other bulky apparatus to that wraps around the head to hold the applicator in place.

[0045] In various embodiments, the width of the tail end of the applicator may be adjusted to allow for additional/fewer trace patterns. The adjustment is performed to add RF zones or reduce RF zones that can be connected to the applicator (i.e. various zones connected through one connector). In various embodiments, trace patterns and thickness of traces are selected to optimize even heating pattern across treatment zone. Trace pattern may be optimized based on size of applicator layout (i.e. for each zone) to minimize hot/cold spots and optimize even heating across the trace pattern when the zone is activated with RF.

[0046] In some embodiments, selective RF heating may be achieved relative to the part of the applicator that is in contact with the patient’s skin or other tissue surface. Selective heating helps avoid heat generation in certain applicator regions such as along the attached electrical connections or switchbacks that connect the attached zones from the main electrical connection region or spine wherein electrical trace density is high. Thus, if a region of an application having a switchback contacts the subject then the subject avoids hot spots or other high heat regions and the associated discomfort of hot spots.

[0047] In some embodiments, various adhesives, belts, frames, clips, and other devices, compounds, and methods are operable to help a given applicator to stay in place once positioned prior to starting an RF delivery session. The devices and methods to maintain such adherence or positioning relative to tissue target region of interest remains active while RF energy is delivered to the skin surface on the submental region, face, thighs, back, stomach, or other tissue targets of interest. Further, the applicator may be designed with one or more features such that it is easy to remove the applicator post-treatment without discomfort to the patient.

Electronic Features, Sensors, and RF related Features [0048] In some embodiments, various methods and algorithms may be used that are based on time, temperature, impedance, and other factors to deliver RF energy in a given zone and across various parts of the whole applicator that is connected back to the RF generator. An example may include a treatment algorithm that includes conditions based on RF ON time in a given electrode region. In another embodiment, the RF ON dwells in a given region until a specific target temperature is reached, then continuing to the next electrode region. Still another embodiment includes regulating the treatment (i.e. switching RF ON/OFF) based on reaching a threshold of relative change of impedance in a given electrode region, where the threshold set by the user may be different per electrode region. Various thicknesses of copper layer may be selected and patterned for the RF trace pattern such as the rectangular and triangular regions shown as nested loops in Figs. 2A and 2B. In various embodiments, copper traces may be designed to optimize RF delivery minimizing hot spots due to concentration of energy delivery by RF in a local area of the applicator. Generally, RF traces are spaced out to equalize heating across the active electrode boundary. This is done by varying the width and spacing of each copper trace. This method can be applied to many shapes and sizes. Trace width and spacing varies as you move away from the center of the pad, more particularly, the trace spacing increases and trace width increases as you move away from the center of a pad.

Hydrogel and Other Surface Preparations

[0049] In various embodiments, a given applicator has a tissue contacting side. The tissue contacting side includes a substance that is wet enough to conform to the stratum comeum therebetween. For example, in at least one embodiment, a thin adhesive that is micro-conformable (i.e., “wet”) enough to conform to the stratum corneum will work well to allow coupling into the skin. The thin adhesive facilitates avoiding air gaps, which can reduce how much current can be coupled into the body. The air gap is filled with something water-based, and optimally water- based with a current-carrying ion, such as saline as part of various methods of treatment. For example, a suitable substance can include a hydrogel. In an alternate embodiment, an aggressive thin adhesive would also work, but should be made in a way to allow it to “wet” into the stratum corneum. In various embodiments, the applicator can be pre-wetted such that a cover is peeled off prior to application of the wet side to the subject’s skin.

[0050] In one embodiment, the first side and second side correspond to a vinyl side and a wet side, or vice versa. Alternatively, in one embodiment, the first side and second side correspond to a patient facing side and an air facing side, or vice versa. During treatment, the wet side is placed in contact with patient tissue to be treated. In some embodiments, an aqueous gel such as a hydrogel is applied to the tissue facing / wet side to reduce or avoid air gaps. Further, the use of such a gel may improve the amount of current that can penetrate the tissue. In various embodiments, one or more thermistors are placed within each zone to monitor temperature during a given treatment method. Temperature sensor are in communication with a control system and can be used to change current levels when higher RF energy and associated current level may otherwise cause edge effects or instances of non-uniform heating. In at least one embodiment, a six zone applicator includes a thermistor in each of the zones.

[0051] In addition to hydrogel adhesive in main part of applicator, a perimeter adhesive layer is used to hold the submental and face applicators in place during treatment. The perimeter adhesive layer advantageously overcomes the force of gravity due to the angle of the positioning of the patient and applicator. In some embodiments, the perimeter adhesive is selected to promote release and adhesion during treatment while also facilitating more comfortable movement by the patient during treatment. Supporting more comfortable patient movement also the patient to read a book or scan their phone while not having to manage applicator detachment. The goal when selecting the perimeter adhesive is to balance the adhesive strength in favor of comfort of removal of the adhesive with tackiness, which relates to the ability to remain attached to the skin despite movement of the subject. All or a portion of the perimeter of the applicator(s) may include the perimeter adhesive. Suitable perimeter adhesives may be sourced from 3M Company (St. Paul Minnesota) and can include one or more of the Medical Tape adhesives available from 3M including 3M Medical Tape 1509, 2477P, 1522 H and 1504XL.

[0052] In various embodiments, the thickness of the hydrogel layer is and/or volumetric resistivity of the hydrogel layer is selected to optimize RF delivery to the treatment area. In various embodiments, the thickness of the hydrogel layer ranges from about 27 mils to about 37 mils. In some embodiments, the volumetric resistivity of the hydrogel layer ranges from about 130 to about 230 Ohm-in or from about 170 to about 190 Ohm-in, or from about 183 to about 188 Ohm-in. Exemplary Layer Arrangements

[0053] In some embodiments, a given applicator or portion of an applicator may be fabricated using a plurality of layers. The various layers may be stacked in some embodiments such that some layers or regions of layers sandwich other layers or regions of layers.

[0054] In various embodiments, a soldermask, a first adhesive layers, a base copper layer, a second adhesive layer, and a coverlay or soldermask layer are combined to form a stiffened flexible applicator or portion thereof. In various embodiments the thickness of the various layers ranges from about 0.6 MIL to about 1.5 MIL. In some embodiments, a stiffener is added to the stiffened flexible applicator or portion thereof. The stiffener is a portion of a printed circuit board (PCB) that is inserted into the connector. The stiffened flexible applicator has a rigid portion of FR4 material for the connector to clamp onto. Solder mask can be permanent and is the portion of the rigid section that covers the traces.

[0055] In various embodiments, to form the flexible portion of the applicator (that which is not stiffened) a Kapton layer, a first adhesive layers, a base copper layer, a base polyamide layer, a second adhesive layer, and a Kapton layer are combined to form the flexible applicator or a portion thereof. In various embodiments of flexible applicator materials and stiffened flexible applicator materials the thickness of each of the various layers ranges from about 0.6 MIL to about 1.5 MIL.

[0056] Several pre-manufactured laminates are used to form flexible PCBs. The base polyamide is a copper-polyamide laminate in which the RF traces are etched. This laminate then gets a coverlay or another layer or overlay applied to each side.

Thermistors and Temperature Sensing Features

[0057] Energy delivery control for each applicator zone is based on thermistor T obtained measurements within each applicator zone and amongst each individual zone connected by a switchback to the main RF source. Various thermistors T are shown in applicator embodiments of Figs. 2A and 2B.

[0058] Thermistors may be placed in different parts of an applicator to measure temperature in a specific location. These thermistors may communicate to the RF treatment system or a control system thereof to determine RF activation in a given zone and guide proper application to the treatment area.

[0059] In various embodiments, the pattern of the electrical traces is designed to have symmetry relative to the thermistor positions within RF delivery zone of given applicator. In this way, a given thermistor, which collects data to generate temperature measurements or otherwise relay temperature-based control signals which in turn are used to guide a given RF energy delivery session.

[0060] In case there is a non-contact issue by the flexible applicator on the skin surface, an algorithm can be used to detect changes in thermistor measurements and alert the user, the applicator can also be removed and reapplied while pressing down firmly across the applicator to ensure even adherence of the applicator. In addition, the specific zone on the applicator that does not have good adherence may be deactivated for the treatment.

[0061] In various embodiments, the applicator features kerfs K. The kerfs are voids or cut outs in the flexible layer stacks that functions in a manner akin to a dart in a garment that enables the applicator sheet to accept the contour of the body while maintaining contact. Use of kerfs enables improved tolerance in sheet thickness. When the applicator size is above a treatment area of about 50 cm² or so then kerfs may be used to provide flexibility in the applicator. Kerfs K enable the applicator to contour to larger treatment areas and are used for multiple zones / regions Rl-RN in a single applicator. Further, for treatment areas having any size including smaller than 50 cm² kerfs may be used to tailor the applicator to a specific treatment area including a relatively smaller treatment area.

[0062] In general, the regions or zones of an applicator are separated with kerfs, channels, gaps, cavities, voids, or other defined spaces to facilitate the use of one flexible applicator that can bend and be adjustable relative to a tissue region such as stomach, abdomen, submental region, organs, organ systems, skin, subcutaneous tissue, body tissue, any of a number of areas of the face, arms, legs, and other regions, lumens, or volumes of a patient. These applicators can bend about a body region such as all or a portion of a region of the face, chest, arms, and legs. In this way, these applicators can wrap about the body area. The selective and alternating energizing of regions of a given applicator is performed to facilitate uniform heating of target tissue subject to the regions of a given RF -based applicator being separated along one or more boundaries, such as kerfs or channels. [0063] The dielectric of the applicator has a dielectric constant that ranges about 3 to about 4, which provides a balance of capacitance vs. dielectric thickness while also having flexibility suitable for a patient tissue contacting applicator. As another consideration, when selecting dielectric material for an applicator, it is desirable for the material to have a low heat loss or heat dissipation factor and also be tolerant of high temperatures to permit soldering of components relative to conductors used with the dielectric material. Further, the selected dielectric of the applicator is skin safe and biocompatible. For example, in one embodiment, Kapton is one dielectric that fulfills these requirements. However, Kapton could be replace by other suitable materials.

[0064] Additional details relating to various systems for using RF and impedance sensing to treat tissue are disclosed in U.S. Publication No. 20200352633 entitled “NON-INVASIVE, UNIFORM AND NON-UNIFORM RF METHODS AND SYSTEMS RELATED APPLICATIONS”, the entire disclosure of which is hereby incorporated by reference in its entirety.

[0065] It will be appreciated that for clarity, the following discussion will explicate various aspects of embodiments of the applicant’s teachings, while omitting certain specific details wherever convenient or appropriate to do so. For example, discussion of like or analogous features in alternative embodiments may be somewhat abbreviated. Well-known ideas or concepts may also for brevity not be discussed in any great detail. The skilled person will recognize that some embodiments of the applicant’s teachings may not require certain of the specifically described details in every implementation, which are set forth herein only to provide a thorough understanding of the embodiments. Similarly, it will be apparent that the described embodiments may be susceptible to alteration or variation according to common general knowledge without departing from the scope of the disclosure. The following detailed description of embodiments is not to be regarded as limiting the scope of the applicant’s teachings in any manner.

[0066] The terms “about” and “substantially identical” as used herein, refer to variations in a numerical quantity that can occur, for example, through measuring or handling procedures in the real world; through inadvertent error in these procedures; through differences/faults in the manufacture of electrical elements; through electrical losses; as well as variations that would be recognized by one skilled in the art as being equivalent so long as such variations do not encompass known values practiced by the prior art. Typically, the term “about” means greater or lesser than the value or range of values stated by 1/10 of the stated value, e.g., ±10%. For instance, applying a voltage of about +3V DC to an element can mean a voltage between ±2.7V DC and +3.3V DC. Likewise, wherein values are said to be “substantially identical,” the values may differ by up to 5%. Whether or not modified by the term “about” or “substantially” identical, quantitative values recited in the claims include equivalents to the recited values, e.g., variations in the numerical quantity of such values that can occur, but would be recognized to be equivalents by a person skilled in the art.

[0067] Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. To aid the Patent Office and any readers of any patent issued on this application in interpreting the claims appended hereto or otherwise presented throughout prosecution of this or any continuing patent application, applicants wish to note that they do not intend any claimed feature to be construed under or otherwise to invoke the provisions of 35 USC 112(f), unless the phrase "means for" or "step for" is explicitly used in the particular claim.

[0068] All of the drawings submitted herewith include one or more ornamental features and views, each of which include solid lines any of which also incorporate and correspond to and provide support for dotted lines and alternatively, each of which include dotted lines any of which also incorporate and correspond to and provide support for solid lines.

[0069] The use of the terms “include,” “includes,” “including,” “have,” “has,” or “having” should be generally understood as open-ended and non-limiting unless specifically stated otherwise.

[0070] The use of the singular herein includes the plural (and vice versa) unless specifically stated otherwise. Moreover, the singular forms “a,” “an,” and “the” include plural forms unless the context clearly dictates otherwise. In addition, where the use of the term “about” is before a quantitative value, the present teachings also include the specific quantitative value itself, unless specifically stated otherwise.

[0071] It should be understood that the order of steps or order for performing certain actions is immaterial so long as the present teachings remain operable. Moreover, two or more steps or actions may be conducted simultaneously. [0072] Where a range or list of values is provided, each intervening value between the upper and lower limits of that range or list of values is individually contemplated and is encompassed within the disclosure as if each value were specifically enumerated herein. In addition, smaller ranges between and including the upper and lower limits of a given range are contemplated and encompassed within the disclosure. The listing of exemplary values or ranges is not a disclaimer of other values or ranges between and including the upper and lower limits of a given range.

[0073] It should be appreciated that numerous changes can be made to the disclosed embodiments without departing from the scope of the present teachings. While the foregoing figures and examples refer to specific elements, this is intended to be by way of example and illustration only and not by way of limitation. It should be appreciated by the person skilled in the art that various changes can be made in form and details to the disclosed embodiments without departing from the scope of the teachings encompassed by the appended claims.

Claims

1. A radiofrequency (RF)-based treatment system comprising: a first flexible applicator comprising a plurality of layers, a hub region comprising one or more electrical connector contact regions, one or more RF delivery regions, and a first electrical connection comprising a conductive material; and a second flexible applicator comprising the plurality of layers, and one or more RF delivery regions, wherein the second flexible applicator is in electrical communication with the first electrical connection.

2. The RF-based treatment system of claim 1 wherein the first flexible applicator further comprises a second electrical connection comprising the conductive material.

3. The RF-based treatment system of claim 2 further comprising a third flexible applicator comprising the plurality of layers, and one or more RF delivery regions, wherein the third flexible applicator is in electrical communication with the second electrical connection.

4. The RF-based treatment system of claim 1 wherein the first applicator is a submental applicator.

5. The RF-based treatment system of claim 3 wherein the first electrical connection and the second electrical connection are flexible ribbons comprising the layers.

6. The RF-based treatment system of claim 3 wherein second flexible applicator extends from the first electrical connection.

7. The RF-based treatment system of claim 6 wherein the third flexible applicator extends from the second electrical connection.

8. The RF-based treatment system of claim 1 wherein the plurality of layers comprises a first dielectric layer, a second dielectric layer, and a conductive layer, wherein the first dielectric layer and the second dielectric layer sandwich the conductive layer.

9. The RF-based treatment system of claim 8, wherein the conductive layers defines one or more conductive trace patterns, each conductive trace pattern is positioned above one or more RF delivery regions.

10 The RF-based treatment system of claim 1, wherein the plurality of layers further comprises one or more adhesive layers, a polyamide layer, and an aqueous gel layer.

11. The RF-based treatment system of claim 1, wherein each applicator defines an applicator shape, wherein applicator shape is selected from the group consisting of elliptical, circular, substantially elliptical, triangular, rectangular, substantially circular, pear shaped, substantially pear shaped, submental, and combinations thereof.

12. The RF-based treatment system of claim 10 further comprising an RF treatment system comprising an RF generator, the RF generator having an operating frequency that ranges from about 0.5 MHz to about 10 MHz, wherein the RF generator is in electrical communication with the electrical connector.

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

14. The RF-based treatment system of claim 12 wherein copper traces arranged along the inner region are arranged in a series of triangular or rectangular regions.

15. The RF-based treatment system of claim 1 further comprising one or more temperature sensors per each RF delivery region, wherein the temperature sensor are in electrical communication with one or more conductive electrical contacts positioned in the elongate hub region.

16. The RF-based treatment system of claim 10 further comprising an RF treatment system comprising an interface device in communication with the RF treatment system, the interface device comprising a clamp and a cable adapter, wherein the clamp opens and closes to releasably connect and align with electrical connector, wherein cable adapter is in electrical communication with electric contacts of clamp.

17. The RF-based treatment system of claim 1, wherein area of RF delivery region ranges from about 50 cm² to about 600 cm².

18. The RF-based treatment system of claim 1, wherein area of RF delivery region ranges from about 600 cm² to about 1200 cm².

19. The RF-based treatment system of claim 18 further comprising an RF treatment system in electrical communication with the applicator and each temperature sensor, further comprising a control system, wherein control system selectively addresses on or more of the applicators to transmit RF energy.

20. The RF-based treatment system of claim 1, wherein one or more temperature sensors a disposed between one or more layers of each applicator.

21. The RF-based treatment system of claim 4 wherein the second applicator is sized to treat one of a cheek, a jowl, a forehead, chest, or a decolletage.

22. The RF-based treatment system of claim 1 wherein the first applicator is sized to treat an area that ranges from about 50 cm² to about 600 cm².

23. The RF-based treatment system of claim 21 wherein the first applicator is sized to treat all or a portion of an abdomen, a thigh, an arm, or a buttocks.

24. The RF-based treatment system of claim 23 wherein the second applicator is sized to treat all or a portion of an abdomen, a thigh, an arm, or a buttocks.

25. The RF-based treatment system of claim 23 wherein the second applicator is sized to treat all or a portion of a submental area, a cheek, a jowl, a forehead, chest, or a decolletage.

26. The RF-based treatment system of claim 1 wherein the plurality of layers in one or both applicators define a plurality of kerfs, and an inner region and N regions extending from the inner region, wherein the plurality of kerfs divide the applicator into N regions.