Systems and methods for measuring elasticity using multi-dimensional ultrasound multi-focus shear waves for imaging

Abstract

Embodiments of skin cosmetic treatment and / or imaging systems and methods are adapted to alter the placement and position of multiple (e.g., two or more) cosmetic treatment zones in tissue from an ultrasound beam from a transducer, to perform simultaneous multifocal treatment at multiple depths, and / or to vibrate the ultrasound beam from the transducer to alter the placement and position of multiple cosmetic treatment zones in tissue. The system may include a cane, a removable transducer module, and a control module. In some embodiments, the cosmetic treatment system can be used in various cosmetic procedures.

Description

Incorporated by citation

[0001] The entire contents of U.S. Provisional Patent Application No. 62 / 874,374, filed July 15, 2019, are incorporated herein by reference for all purposes. Technical Field

[0002] Several embodiments of the present invention relate to energy-based non-invasive treatments for achieving aesthetic and / or cosmetic enhancements on the skin and / or tissues near the skin of the face, head, neck, and / or body by delivering energy simultaneously or nearly simultaneously to multiple dimensions (e.g., two or more depths, heights, widths, spacings, orientations, placements) of tissue beneath the skin surface. In particular, several embodiments relate to measuring skin elasticity using constructive shear wave imaging generated by delivering focused energy simultaneously or nearly simultaneously to multiple dimensions. Background Technology

[0003] Some cosmetic procedures involve invasive procedures that may require surgery. Patients not only have to endure weeks of recovery time but also often require risky anesthesia. Non-invasive energy-based treatment devices and methods are available, but they may have various drawbacks in terms of efficiency, effectiveness, and the feedback provided on the efficiency and effectiveness of treatment. Summary of the Invention

[0004] In several embodiments, systems and methods are provided for using targeted and precise ultrasound to provide feedback on the effectiveness of treatment outcomes. This is achieved by splitting the ultrasound treatment beam into two, three, four, or more simultaneously focused zones via a thermal path to produce visible and effective results for various treatment and / or imaging procedures. When using predetermined treatment doses and densities, some recipients of a treatment procedure may respond more quickly or more favorably to treatment due to individual morphological differences from person to person. Therefore, feedback on the progress of therapeutic treatment improves efficacy and outcome consistency. For therapeutic treatments that cause improvement in skin and surrounding skin laxity, a method for measuring tissue elasticity can provide this feedback, serving as an alternative measure of tissue laxity during treatment. In several embodiments, constructive shearwave imaging measures tissue displacement from a transducer that generates two or more simultaneously focused zones, which produce a displacement / velocity profile within the tissue. The tissue response as this displacement propagates is a shear wave that converges to a single point for shearwave imaging. The properties of converging shear waves, such as arrival time, peak displacement, rise time, and fall time, provide insight into the resilience of tissues between two or more simultaneously focused regions.

[0005] The embodiments described herein are particularly useful for aesthetic and other procedures in which real-time (manual or automatic) adjustment of treatment parameters is beneficial. In embodiments treating a single subject in a single time period, one or more parameters, such as frequency, power, intensity, duration, and the location of the treatment point (treatment), are modified based on the elasticity of the tissue beneath the skin surface. When multiple thermal coagulation point lines are generated (e.g., two or more), parameters can be varied between points and / or lines on the face or body. As an example, if the subject has insufficient elasticity in a certain area, the duration of treatment can be extended (compared to areas of skin with greater elasticity). In some embodiments, one or more of the frequency, power, intensity, duration, or other parameters are changed (increased or decreased) by 10%-30%, 30%-50%, 50%-100%, 2-3 times, 3-5 times or more, and overlapping ranges therein, and in some embodiments, such changes are related to and / or based on elasticity.

[0006] In various embodiments, the ultrasound system is configured to focus ultrasound to generate localized mechanical motion within tissues and cells to produce localized heating for tissue coagulation or mechanical cell membrane rupture for non-invasive aesthetic purposes. In various embodiments, the ultrasound system is configured to lift eyebrows (e.g., brow lift). In various embodiments, the ultrasound system is configured to lift loose, sagging, or drooping tissue, such as submental (below the chin) and neck tissue. In various embodiments, the ultrasound system is configured to improve neckline and wrinkles. In various embodiments, the ultrasound system is configured to reduce fat. In various embodiments, the ultrasound system is configured to reduce the appearance of cellulite. In some embodiments, a system is provided for reducing fat and subsequently treating sagging skin resulting from fat reduction.

[0007] Although this document considers various embodiments for cosmetic treatments, in some embodiments the systems and procedures described herein are also used for non-aesthetic applications.

[0008] In various embodiments, the ultrasound system is configured to image and visualize tissue (e.g., the dermis and subcutaneous layer of the tissue) to ensure proper coupling of the transducer to the skin. In various embodiments, the ultrasound system is configured to image and visualize tissue (e.g., the dermis and subcutaneous layer of the tissue) to confirm appropriate treatment depth to avoid certain tissues (e.g., bone).

[0009] In various embodiments, treating tissue (e.g., skin tissue) with multiple (e.g., two or more) beams provides one or more advantages, such as reduced treatment time, creating unique heating patterns, utilizing multiple channels to obtain greater power, selectively treating the skin at two or more depths with the same or different power levels (e.g., thermal coagulation points in the superficial musculoaponeurotic system (“SMAS”) and another defocused energy at the skin surface, or other combinations), optionally treating simultaneously at different depths (e.g., simultaneously or within overlapping time periods at depths below the skin surface at thermal coagulation points of 1.5 mm, 3 mm, and / or 4.5 mm); and / or treating with one, two, or more simultaneous linear or line-focused beams, for example, at different depths below the skin surface or spaced apart. In some embodiments, simultaneous multifocal treatment uses jitter.

[0010] According to one embodiment, an ultrasound therapy system creates two or more simultaneous treatment points and / or focal zones below the skin surface for cosmetic treatment, wherein the treatment points are expanded by vibrating the ultrasound beam. In one embodiment, the focal zone is a point. In one embodiment, the focal zone is a line. In one embodiment, the focal zone is a plane. In one embodiment, the focal zone is a three-dimensional volume or shape. Vibration of the ultrasound beam focus expands the treatment area by changing the frequency of the ultrasound therapy beam and thus changing the focus by mechanically and / or electronically dispersing the position of the focus, causing the focus or focal zone (e.g., focus, line, plane, or volume) to shake, blur, or splatter like paint using an air brush. In some embodiments, vibration increases efficacy by creating larger treatment points and / or focal zones. In some embodiments, vibration reduces pain because the temperature of the hot spot is distributed over a larger volume of tissue, allowing for a potential dose reduction. In some embodiments, mechanical vibration is a method of expanding acoustic energy from the ultrasound beam, and therefore has less dependence on heat conduction from tissues far from the focus. In one embodiment of mechanical vibration, the treatment transducer is locally moved around the intended center of the thermal coagulation point (TCP). The acoustic beam movement can be side-to-side, up-down, and / or angled. In one embodiment of mechanical vibration, the motion mechanism moves fast enough to produce a flatter temperature distribution around the intended TCP, which allows for a reduction in the total acoustic energy of the same affected tissue volume or the same total acoustic energy of a larger affected tissue volume, or any combination thereof.

[0011] In various embodiments, a system for measuring the elasticity of a material includes: an ultrasonic probe including an ultrasonic transducer configured to deliver a plurality of (e.g., two or more) ultrasonic beams to a material comprising elasticity, the plurality of ultrasonic beams being focused on a plurality of individually spaced focal regions in the material, each ultrasonic beam having sufficient acoustic power to generate shear waves originating from the individually spaced focal regions and proceeding in parallel through the material; an ultrasonic imaging system configured to image shear waves originating from at least two of the plurality of individually spaced focal regions and converging toward a region between at least two of the plurality of individually spaced focal regions; and an electronic processing system configured to: obtain characteristics of the imaged shear waves; and determine the elasticity of a region of the material based on the obtained characteristics. In one embodiment, two or more shear waves originating from at least two focal zones will converge at a point in the medium, depending on the timing of the shear waves (anywhere between the at least two focal zones, including but not limited to the center between the at least two focal zones, or any distance away from the center, such as 10%, 20%, 30%, 40%, 60%, 70%, 80%, or 90% of the distance between the first and second focal zones). In some embodiments, based on the timing of the shear wave generation (e.g., simultaneous to sequence) or tissue differences, the imaging system may direct the line of sight away from the location where the shear waves converge (e.g., with a linear imaging array), or the shear waves may converge at a location that is not half the distance between the focal zones.

[0012] In one embodiment, the characteristics of the imaged shear wave include at least one of the shear wave arrival time, shear wave peak displacement, shear wave rise time, and shear wave fall time. In one embodiment, the ultrasonic transducer is configured to deliver an ultrasonic beam to a material using amplitude modulation to focus the ultrasonic beam at multiple individually spaced focal regions within the material. In one embodiment, the ultrasonic beam is simultaneously focused at multiple individually spaced focal regions within the material. In one embodiment, the ultrasonic beam is sequentially focused at multiple individually spaced focal regions within the material. In one embodiment, the ultrasonic transducer is configured to deliver an ultrasonic beam to a material using frequency modulation to focus the ultrasonic beam at multiple individually spaced focal regions within the material. In one embodiment, the ultrasonic beam is simultaneously focused at multiple individually spaced focal regions within the material. In one embodiment, the ultrasonic beam is sequentially focused at multiple individually spaced focal regions within the material. In one embodiment, at least one ultrasonic transducer is configured to deliver an ultrasonic beam to multiple excitation regions of the material corresponding to the multiple individually spaced focal regions. In one embodiment, the multiple individually spaced focal regions coincide with the multiple excitation regions. In one embodiment, multiple individually spaced focusing zones are separated from multiple excitation zones. In one embodiment, the system further includes a moving component configured to move the ultrasound probe. In one embodiment, the material comprises an organic material. In one embodiment, the material comprises tissue. In one embodiment, the material comprises skin. In one embodiment, an electronic processing system is configured to determine the elasticity of the material in real time while delivering an ultrasound beam to the material. In one embodiment, the system is configured for use in a cosmetic procedure.

[0013] In various embodiments, a method for non-invasively measuring the elasticity of a material includes: coupling an ultrasonic probe including at least one ultrasonic transducer to the material; delivering a plurality of ultrasonic beams from the ultrasonic transducer to the material; focusing the plurality of ultrasonic beams at a plurality of individually spaced focal regions in the material; generating shear waves originating from the plurality of individually spaced focal regions and proceeding in parallel through the material; imaging the shear waves originating from at least two of the plurality of individually spaced focal regions and converging toward a region between at least two of the plurality of individually spaced focal regions; obtaining characteristics of the imaged shear waves; and determining the elasticity of a region of the material based on the obtained characteristics.

[0014] In one embodiment, the characteristics of the imaged shear wave include at least one of the shear wave arrival time, shear wave peak displacement, shear wave rise time, and shear wave fall time. In one embodiment, focusing an ultrasonic beam at a plurality of individually spaced focal zones in a material includes modulating the amplitude or frequency of one or more signals driving an ultrasonic transducer. In one embodiment, the ultrasonic beam is simultaneously focused at a plurality of individually spaced focal zones in a material. In one embodiment, the ultrasonic beam is sequentially focused at a plurality of individually spaced focal zones in a material. In one embodiment, the ultrasonic beam is delivered to a plurality of excitation regions of the material corresponding to the plurality of individually spaced focal zones. In one embodiment, the plurality of individually spaced focal zones coincide with a plurality of excitation regions. In one embodiment, the plurality of individually spaced focal zones are spaced apart from a plurality of excitation regions. In one embodiment, the method includes: moving an ultrasonic probe to focus an ultrasonic beam at a plurality of individually spaced focal zones in a material. In one embodiment, the material comprises an organic material. In one embodiment, the material comprises tissue. In one embodiment, the material comprises skin. In one embodiment, the elasticity of the material is determined in real time while the ultrasonic beam is delivered to the material. In one embodiment, the method includes determining the efficacy of an ultrasound therapy configured to provide cosmetic or aesthetic improvement in a material, wherein the material comprises biological tissue. In one embodiment, determining the efficacy of the ultrasound therapy configured to provide cosmetic or aesthetic improvement includes relating the determined elasticity to the generation of a thermal coagulation point (TCP) in the biological tissue.

[0015] In various embodiments, a method for measuring the elasticity of a material by generating multiple simultaneous focal points includes: coupling an ultrasonic transducer probe to a material surface, wherein the ultrasonic transducer probe includes a single piezoelectric transducer element configured to focus multiple individually spaced focal regions; focusing the multiple individually spaced focal regions on a region below the material surface using the single piezoelectric transducer element, wherein focusing at the multiple individually spaced focal regions is simultaneous; obtaining characteristics of multiple shear waves originating from at least two of the multiple individually focal regions and converging toward a region between at least two of the multiple individually focal regions; determining the elasticity of a region below the skin surface between at least two of the multiple individually focal regions based on the characteristics of the obtained shear waves; and determining the effectiveness of a non-invasive cosmetic procedure based on the determined elasticity, wherein the transducer module includes a single ultrasonic transducer configured to apply ultrasonic treatment to tissue at multiple individually excited regions corresponding to the individual focal regions.

[0016] In one embodiment, the characteristics of the shear wave include at least one of the following: shear wave arrival time, shear wave peak displacement, shear wave rise time, and shear wave fall time. In one embodiment, one of the plurality of individual excitation regions coincides with a corresponding one of the plurality of individual focusing regions. In one embodiment, one of the plurality of individual excitation regions is spaced apart from a corresponding one of the plurality of individual focusing regions.

[0017] In several embodiments described herein, the procedures are entirely cosmetic rather than medical. For example, in one embodiment, the methods described herein do not require a physician to perform, but are performed at a spa or other beauty facility. In some embodiments, the system can be used for non-invasive cosmetic treatments of the skin.

[0018] The methods outlined above and further elaborated below describe certain actions taken by the practitioner; however, it should be understood that they may also include instructions from another party regarding these actions. Thus, an action such as “measuring the shear wave” includes “instructing to measure the shear wave.”

[0019] In some embodiments, the system includes various features that exist as a single feature (as opposed to multiple features). For example, in one embodiment, the system includes a single transducer element that generates two simultaneous therapeutic focal points of jitter. Multiple features or components are provided in alternative embodiments. In various embodiments, the system includes, substantially includes, or includes one, two, three, or more embodiments of any feature or component disclosed herein. In some embodiments, a feature or component is not included and may be negatively waived from a particular claim, such that the system does not have such a feature or component.

[0020] Furthermore, the applicable scope will be apparent from the description provided herein. It should be understood that the descriptions and specific examples are for illustrative purposes only and are not intended to limit the scope of the embodiments disclosed herein. Attached Figure Description

[0021] The accompanying drawings described herein are for illustrative purposes only and are not intended to limit the scope of this disclosure in any way. Embodiments of the invention will be more fully understood from the detailed description and the accompanying drawings, wherein:

[0022] Figure 1A This is a schematic diagram of an ultrasound system according to various embodiments of the present invention.

[0023] Figure 1B This is a schematic diagram of an ultrasound system according to various embodiments of the present invention.

[0024] Figure 1C This is a schematic diagram of an ultrasound system according to various embodiments of the present invention.

[0025] Figure 2This is a schematic diagram of an ultrasound system coupled to a region of interest according to various embodiments of the present invention.

[0026] Figure 3 This is a schematic diagram of a portion of a transducer according to various embodiments of the present invention.

[0027] Figure 4 This is a partial sectional side view of an ultrasound system according to various embodiments of the present invention.

[0028] Figure 5 This is a table illustrating focal separation with different spatial frequencies of apertures according to various embodiments of the present invention.

[0029] Figure 6 This is a graph illustrating the focal separation of apertures with different aperture spatial frequencies according to various embodiments of the present invention.

[0030] Figure 7 This is a graph illustrating the focal separation of apertures with different aperture spatial frequencies according to various embodiments of the present invention.

[0031] Figure 8 This is a schematic diagram of aperture polarization with spatial frequency according to various embodiments of the present invention, wherein the spatial frequency can be modified by an excitation channel.

[0032] Figure 9 This is a schematic diagram of a polarized ceramic with a spatial frequency according to various embodiments of the present invention, the spatial frequency being modifiable by exciting a channel covering two polarization regions of the ceramic.

[0033] Figure 10 This is a schematic diagram of an embodiment of an array transducer with an imaging transducer.

[0034] Figure 11 This is a schematic diagram of a transducer as viewed from the convex side, a side cross-section, and the concave side, according to various embodiments of the present invention.

[0035] Figure 12 This is a schematic diagram of a transducer as viewed from the convex side, a side cross-section, and the concave side, according to various embodiments of the present invention.

[0036] Figure 13 This is a schematic diagram of a transducer as viewed from the convex side, a side cross-section, and the concave side, according to various embodiments of the present invention.

[0037] Figure 14 This is a schematic diagram of a transducer as viewed from the convex side, a side cross-section, and the concave side, according to various embodiments of the present invention.

[0038] Figure 15This is a schematic diagram of a transducer as viewed from the convex side, a side cross-section, and the concave side, according to various embodiments of the present invention.

[0039] Figure 16 This is a schematic diagram of a transducer as viewed from the convex side, a side cross-section, and the concave side, according to various embodiments of the present invention.

[0040] Figure 17 This is a schematic diagram of a transducer viewed from the convex and concave sides according to various embodiments of the present invention.

[0041] Figure 18 This is a schematic diagram of multiple thermally solidified regions at various depths generated by a transducer according to various embodiments of the present invention.

[0042] Figure 19 It is based on Figure 18 A schematic diagram of the xz plane of multiple thermally solidified regions at various depths generated by the transducer.

[0043] Figure 20 It is based on Figure 18 A schematic diagram of the yz plane of multiple thermally solidified regions at various depths generated by the transducer.

[0044] Figure 21 This is a schematic diagram of multiple thermally solidified regions at various depths generated by a transducer according to various embodiments of the present invention.

[0045] Figure 22 It is based on Figure 21 A schematic diagram of the xz plane of multiple thermally solidified regions at various depths generated by the transducer.

[0046] Figure 23 It is based on Figure 21 A schematic diagram of the yz plane of multiple thermally solidified regions at various depths generated by the transducer.

[0047] Figure 24 This is a schematic diagram of multiple thermally solidified regions at various depths generated by a transducer according to various embodiments of the present invention.

[0048] Figure 25 It is based on Figure 24 A schematic diagram of the xz plane of multiple thermally solidified regions at various depths generated by the transducer.

[0049] Figure 26 It is based on Figure 24 A schematic diagram of the yz plane of multiple thermally solidified regions at various depths generated by the transducer.

[0050] Figure 27This is a schematic diagram of multiple thermally solidified regions at various depths generated by a transducer according to various embodiments of the present invention.

[0051] Figure 28 It is based on Figure 27 A schematic diagram of the xz plane of multiple thermally solidified regions at various depths generated by the transducer.

[0052] Figure 29 It is based on Figure 27 A schematic diagram of the yz plane of multiple thermally solidified regions at various depths generated by the transducer.

[0053] Figure 30 This is a schematic diagram of a transducer viewed from the convex and concave sides according to various embodiments of the present invention.

[0054] Figure 31 This is a schematic diagram of multiple thermally solidified regions at various depths generated by a transducer according to various embodiments of the present invention.

[0055] Figure 32 It is based on Figure 31 A schematic diagram of the xz plane of multiple thermally solidified regions at various depths generated by the transducer.

[0056] Figure 33 It is based on Figure 31 A schematic diagram of the yz plane of multiple thermally solidified regions at various depths generated by the transducer.

[0057] Figure 34 This is a schematic diagram of multiple thermally solidified regions at various depths generated by a transducer according to various embodiments of the present invention.

[0058] Figure 35 It is based on Figure 34 A schematic diagram of the xz plane of multiple thermally solidified regions at various depths generated by the transducer.

[0059] Figure 36 It is based on Figure 34 A schematic diagram of the yz plane of multiple thermally solidified regions at various depths generated by the transducer.

[0060] Figure 37 This is a graph showing the amplitude and DC of the focal plane point generated by the transducer corresponding to various embodiments of the present invention.

[0061] Figure 38 An example of a region analyzed using constructive shear wave imaging is illustrated schematically.

[0062] Figure 39This schematically illustrates a method for using constructive shear wave imaging to query tissue in the region between two ultrasound-excited areas that coincide with a corresponding treatment point.

[0063] Figure 40 This schematically illustrates a method for using constructive shear wave imaging to query tissue in a region between two ultrasound-excited regions spaced apart from a corresponding treatment point.

[0064] Figure 41 An embodiment of constructive shear wave imaging using a multifocal transducer is illustrated, which involves modulating the transmission frequency of the excitation pulse.

[0065] Figure 42 An example is illustrated schematically, showing a graph illustrating the change in shear wave velocity as tissue heats up and solidifies.

[0066] Figure 43 Examples of methods or systems for measuring tissue elasticity and administering treatment dosages within a single sweep are illustrated schematically.

[0067] Figure 44 An embodiment of elasticity measurement is illustrated when a single outward sweep includes a pre-dose elasticity measurement and subsequent treatment doses at each location.

[0068] Figure 45 An embodiment of elasticity measurement before and / or after the application of a therapeutic dose is illustrated schematically.

[0069] Figure 46 An embodiment of CSI shear wave is illustrated schematically, wherein the depth of the excitation region and the excitation interval can be controlled. Detailed Implementation

[0070] The following description illustrates examples of embodiments and is not intended to limit the invention, its teachings, applications, or uses. It should be understood that throughout the drawings, corresponding reference numerals denote the same or corresponding parts and features. The description of specific embodiments indicated in the various embodiments of the invention is for illustrative purposes only and is not intended to limit the scope of the invention disclosed herein. Moreover, the description of multiple embodiments having the described features is not intended to exclude other embodiments having additional features or other embodiments containing different combinations of the described features. Furthermore, a feature in one embodiment (e.g., in one figure) may be combined with the description (and figures) of other embodiments.

[0071] In various embodiments, systems and methods for ultrasound therapy of tissues are adapted and / or configured to provide cosmetic treatments. In some embodiments, apparatus and methods are provided in several examples to direct ultrasound therapy to a single focal point or multiple simultaneous focal points, employing ultrasound imaging to confirm sufficient acoustic coupling to the treatment area to improve performance or to provide improved correlation between movement in first and second directions when forming images in cosmetic and / or medical procedures. In various embodiments as used herein, “simultaneous” means occurring simultaneously, or with a time difference of less than 1 ms, 0.5 ms, 0.1 ms, 0.05 ms, or 0.01 ms. In various embodiments, tissues below or even at the skin surface, such as the epidermis, dermis, fascia, muscle, fat, and superficial musculoaponeurotic system (“SMAS”), are treated non-invasively with ultrasound energy. The ultrasound energy may be focused on one or more treatment points and / or areas, may be unfocused and / or defocused, and may be applied to a region of interest comprising at least one of the epidermis, dermis, hypodermis, fascia, muscle, fat, cellulite, and SMAS to achieve cosmetic and / or therapeutic effects. In various embodiments, the system and / or method delivers non-invasive skin treatments to tissue via heat treatment, coagulation, ablation, and / or tightening. In several embodiments disclosed herein, non-invasive ultrasound is used to achieve one or more of the following effects: face lifting, eyebrow lifting, chin lifting, eye treatments (e.g., cheekbone bags, treatment of infraorbital laxity), wrinkle reduction, fat reduction (e.g., treatment of fat and / or cellulite), cellulite treatment (e.g., depressed or non-depressed female lipodystrophy), shoulder improvement (e.g., upper chest), buttock lifting (e.g., buttock tightening), skin laxity treatment (e.g., treating tissue for tightening or abdominal laxity treatment), scar reduction, burn treatment, tattoo removal, vein removal, vein reduction, treatment of sweat glands, treatment of hyperhidrosis, sunspot removal, acne treatment, and papule removal. In one embodiment, fat reduction is achieved. In various embodiments, compared to, for example, untreated tissue, cellulite (e.g., depressed or non-depressed female lipodystrophy) with one or more characteristics (e.g., depressions, nodules, "orange peel" appearance, etc.) is reduced or improved by about 10-20%, 20-40%, 40-60%, 60-80%, or more (and overlapping ranges therein). In one embodiment, the shoulder is treated. In some embodiments, two, three, or more beneficial effects are achieved in the same treatment session and may be achieved simultaneously.

[0072] Various embodiments of the present invention relate to apparatus or methods for controlling the delivery of energy to tissue. In various embodiments, various forms of energy may include sound, ultrasound, light, laser, radio frequency (RF), microwave, electromagnetic, radiation, heat, cryogenic, electron beam, photon-based, magnetic, magnetic resonance, and / or other forms of energy. Various embodiments of the present invention relate to apparatus or methods for splitting an ultrasound energy beam into multiple beams. In various embodiments, the apparatus or method can be used to modify the delivery of ultrasound acoustic energy in any procedure, such as, but not limited to, therapeutic ultrasound, diagnostic ultrasound, ultrasonic welding, any application involving coupling mechanical waves to an object, and other procedures. Typically, therapeutic ultrasound achieves tissue effects by focusing acoustic energy from an aperture using focusing techniques. In some cases, high-intensity focused ultrasound (HIFU) is used in this manner for therapeutic purposes. In one embodiment, the tissue effect produced by applying therapeutic ultrasound at a specific depth may be referred to as the generation of a thermal coagulation point (TCP). In some embodiments, the region may include a point. In some embodiments, the region is a line, plane, sphere, ellipse, cube, or other one-dimensional, two-dimensional, or three-dimensional shape. By generating a TCP at a specific location, thermal and / or mechanical ablation of tissue can occur non-invasively or remotely. In some embodiments, ultrasound therapy does not include cavitation and / or shock waves. In some embodiments, ultrasound therapy includes cavitation and / or shock waves.

[0073] In one embodiment, TCPs can be generated in linear or substantially linear, curved or substantially curved regions or sequences, wherein each individual TCP is separated from adjacent TCPs by treatment intervals. In one embodiment, multiple TCP sequences can be generated within the treatment region. For example, TCPs can be formed along a first sequence and a second sequence separated from the first sequence by a treatment distance. Although treatment with therapeutic ultrasound can be administered by generating individual TCPs in one or more sequences of individual TCPs, it may be desirable to reduce treatment time and the corresponding risk of pain and / or discomfort experienced by the patient. Treatment time can be reduced by generating multiple TCPs simultaneously, almost simultaneously, or sequentially. In some embodiments, by generating multiple TCPs, treatment time can be reduced by 10%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, or more.

[0074] Various embodiments of the present invention address potential challenges associated with the application of ultrasound therapy. In various embodiments, the time required for TCP formation in the cosmetic and / or therapeutic procedures needed to achieve the desired clinical approach at the target tissue is reduced. In various embodiments, the target tissue is, but is not limited to, any of the following: skin, eyelids, eyelashes, eyebrows, lacrimal canaliculi, crow's feet, wrinkles, eyes, nose, mouth (e.g., nasolabial folds, perioral wrinkles), tongue, teeth, gums, ears, brain, heart, lungs, ribs, abdomen (e.g., for abdominal laxity), stomach, liver, kidneys, uterus, breast, vagina, prostate, testes, glands, thyroid gland, internal organs, hair, muscles, bones, ligaments, cartilage, fat, adipose lobes, adipose tissue, subcutaneous tissue, implanted tissue, implanted organ, lymph nodes, tumors, cysts, abscesses, or part of a nerve, or any combination thereof.

[0075] Various embodiments of simultaneous ultrasound treatment at multiple locations within an organization are described in U.S. Application No. 14 / 193,234, published September 11, 2014, as U.S. Patent No. 2014 / 0257145, which is incorporated herein by reference in its entirety.

[0076] System Overview

[0077] refer to Figure 1A , 1BVarious embodiments of the ultrasound system 20, including 1C, include a cane (e.g., a handpiece) 100, modules (e.g., transducer modules, boxes, probes) 200, and a controller (e.g., a console) 300. In some embodiments, the controller 300 includes a communication system (e.g., Wi-Fi, Bluetooth, modem, etc.) for communicating with another party, manufacturer, supplier, service provider, the Internet, and / or the cloud. In some embodiments, a cart 301 provides mobility and / or location for the system 20 and may include wheels, a surface on which parts are written or placed, and / or compartments 302 (e.g., drawers, containers, shelves, etc.) for, for example, storing or organizing parts. In some embodiments, the cart has a power source, such as a power connection to a battery, and / or one or more wires connecting power, communication (e.g., Ethernet), to the system 20. In some embodiments, the system 20 includes a cart 301. In some embodiments, the system 20 does not include a cart 301. The cane 100 may be coupled to the controller 300 via an interface 130, which may be a wired or wireless interface. Interface 130 can be coupled to cane 100 via connector 145. The distal end of interface 130 can connect to a controller connector on a circuit (not shown). In one embodiment, interface 130 can transmit controllable power from controller 300 to cane 100. In one embodiment, system 20 has multiple imaging channels (e.g., eight channels) for ultra-clear HD (high-definition) visualization of subcutaneous structures to improve imaging. In one embodiment, system 20 includes multiple treatment channels (e.g., eight channels) and a precision linear drive motor that doubles treatment accuracy while increasing speed (e.g., 25%, 40%, 50%, 60%, 75%, 100% or more). These features together establish one of the most versatile system platforms in the industry and lay the foundation for unprecedented future possibilities.

[0078] In various embodiments, controller 300 may be adapted and / or configured to operate in conjunction with the cane 100 and module 200, as well as the overall functionality of ultrasound system 20. In various embodiments, multiple controllers 300 may be adapted and / or configured to operate in conjunction with multiple canes 100 and / or multiple modules 200. Controller 300 may include connectivity to one or more interactive graphic displays 310, which may include a touchscreen monitor and a graphical user interface (GUI) allowing the user to interact with ultrasound system 20. In one embodiment, a second, smaller, more mobile display allows the user to more easily locate and view the treatment screen. In one embodiment, the second display allows the system user to view the treatment screen (e.g., on a wall, on a mobile device, on a large screen, on a remote screen). In one embodiment, graphic display 310 includes a touchscreen interface (not shown). In various embodiments, display 310 sets and displays operating conditions, including device activation status, treatment parameters, system messages and prompts, and ultrasound images. In various embodiments, controller 300 may be adapted and / or configured to include, for example, a microprocessor with software and input / output devices; systems and devices for controlling multiplexing of electronic and / or mechanical scanning and / or transducers and / or multiplexing of transducer modules; systems for power delivery; systems for monitoring; systems for sensing the spatial position of probes and / or transducers and / or multiplexing of transducer modules; and / or systems for processing user input and recording treatment results, etc. In various embodiments, controller 300 may include a system processor and one or more of various analog and / or digital control logics, such as microcontrollers, microprocessors, field-programmable gate arrays, computer boards, and related components, including firmware and control software that may be able to interface with user controls and interface circuitry, as well as input / output circuitry and system for communication, display, interface, storage, documentation, and other useful functions. System software running on system processes may be adapted and / or configured to control all initialization, timing, level setting, monitoring, safety monitoring, and all other ultrasound system functions for achieving user-defined treatment goals. In addition, the controller 300 may include various input / output modules, such as switches, buttons, etc., which may also be suitably adapted and / or configured to control the operation of the ultrasound system 20.

[0079] In one embodiment, the cane 100 includes one or more finger-activated controllers or switches, such as 150 and 160. In various embodiments, one or more heat treatment controllers 160 (e.g., switches, buttons) initiate and / or deactivate treatment. In various embodiments, one or more imaging controllers 150 (e.g., switches, buttons) initiate and / or deactivate imaging. In one embodiment, the cane 100 may include a removable module 200. In other embodiments, the module 200 may be non-removable. In various embodiments, the module 200 may be mechanically coupled to the cane 100 using a latch or coupler 140. In various embodiments, one or more interface guides 235 may be used to facilitate coupling the module 200 to the cane 100. The module 200 may include one or more ultrasound transducers 280. In some embodiments, the ultrasound transducer 280 includes one or more ultrasound elements. The cane 100 may include an imaging-only module, a treatment-only module, an imaging and treatment module, etc. In various embodiments, the ultrasonic transducer 280 is movable within module 200 in one or more directions 290. The transducer 280 is connected to a motion mechanism 400. In various embodiments, the motion mechanism includes one or more bearings, shafts, rods, screws, lead screws 401, encoders 402 (e.g., optical encoders for measuring the position of the transducer 280), and motors 403 (e.g., stepper motors) to help ensure accurate and repeatable movement of the transducer 280 within module 200. In various embodiments, module 200 may include the transducer 280, which can emit energy through an acoustically transparent member 230. In one embodiment, a control module may be coupled to cane 100 via interface 130, and a graphical user interface may be adapted and / or configured for controlling module 200. In one embodiment, the control module may provide power to cane 100. In one embodiment, cane 100 may include a power source. In one embodiment, switch 150 may be adapted and / or configured for controlling tissue imaging functions, and switch 160 may be adapted and / or configured for controlling tissue treatment functions. In various embodiments, module 200 delivers emitted energy 50 with appropriate depth of focus, distribution, timing, and energy level through controlled operation of the transducer 280's control system to achieve the desired therapeutic effect with thermal coagulation region 550 ("TCP, e.g., thermal coagulation point").

[0080] In one embodiment, module 200 may be coupled to cane 100. Module 200 may emit and receive energy, such as ultrasonic energy. Module 200 may be electronically coupled to cane 100, and this coupling may include an interface for communication with controller 300. In one embodiment, interface guide 235 may be adapted and / or configured to provide electronic communication between module 200 and cane 100. Module 200 may include various probe and / or transducer configurations. For example, module 200 may be adapted and / or configured for use with combined dual-mode imaging / therapy transducers, coupled or co-located imaging / therapy transducers, separate therapy and imaging probes, etc. In one embodiment, when module 200 is inserted into or connected to cane 100, controller 300 automatically detects it and updates interactive graphical display 310.

[0081] In some embodiments, an access key 320 (e.g., a secure USB drive, a key) is connected (e.g., removably) to system 20 to allow system 20 to function. In various embodiments, the access key is programmed to be customer-specific and serves multiple functions, including system security, country-specific access to treatment guidelines and functions, software upgrades, support log transmission and / or credit transfer and / or storage. In various embodiments, system 20 has internet and / or data connectivity. In embodiments, connectivity provides a method for transferring data between a provider of system 20 and a customer. In various embodiments, the data includes credits, software updates, and support logs. Connectivity is categorized into different model embodiments based on how the user console is connected to the internet. In one embodiment, disconnected model connectivity includes a console disconnected from the internet and the customer cannot access the internet. Credit transfer and software upgrades are performed by sending an access key (e.g., a USB drive) to the customer. In one embodiment, semi-connected model connectivity includes a console disconnected from the internet, but the customer can access the internet. Credit transfer, software upgrades, and support log transmission are performed using the customer's personal computer, smartphone, or other computing device in conjunction with the system access key to transmit data. In one embodiment, the fully connected model connectivity includes a console wirelessly connected to the internet using Wi-Fi, a cellular modem, Bluetooth, or other protocols. Credit transfers, software upgrades, and support log transmissions occur directly between the console and the cloud. In various embodiments, system 20 connects to an online portal to streamline inventory management, process purchases on demand, and provide business analytics insights to take clients' beauty treatment businesses to the next level.

[0082] In various embodiments, ultrasound energy is used to non-invasively treat tissues beneath or even on the skin surface, such as the epidermis, dermis, hypothalamus, fascia, and superficial musculoaponeurotic system (“SMAS”) and / or muscles. The tissue may also include blood vessels and / or nerves. The ultrasound energy may be focused, unfocused, or defocused and applied to a region of interest comprising at least one of the epidermis, dermis, hypothalamus, fascia, and SMAS to achieve a therapeutic effect. Figure 2 This is a schematic diagram of an ultrasound system 20 coupled to a region of interest. In various embodiments, the tissue layer of the region of interest can be located in any part of the subject's body. In one embodiment, the tissue layer is located in the head and facial region of the subject. A cross-sectional portion of the tissue in the region of interest includes a skin surface 501, an epidermal layer 502, a dermal layer 503, a fat layer 505, a superficial musculoaponeurotic system 507 (hereinafter referred to as "SMAS 507"), and a muscle layer 509. The tissue may also include subcutaneous tissue 504, which may include any tissue beneath the dermal layer 503. The combination of these layers may be collectively referred to as subcutaneous tissue. Figure 2 The treatment area 525 located beneath surface 501 is also shown. In one embodiment, surface 501 may be the skin surface of subject 500. Although embodiments involving treatment at tissue layers may be used as examples herein, the system can be applied to any tissue in the body. In various embodiments, the system and / or method can be used on tissues (including, but not limited to, muscles, fascia, SMAS, dermis, epidermis, fat, adipocytes, cellulosic tissues, which may be referred to as female lipodystrophy (e.g., non-pitted female lipodystrophy), collagen, skin, blood vessels) in the face, neck, head, arms, legs, or any other location on or within the body (including body cavities). In various embodiments, cellulosic tissue (e.g., non-pitted female lipodystrophy) reduction amounts to 2%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 75%, 80%, 90%, 95%, and any range thereof.

[0083] refer to Figure 2 As illustrated in the diagram, an embodiment of the ultrasound system 20 includes a cane 100, a module 200, and a controller 300. In one embodiment, the module 200 includes a transducer 280. Figure 3An embodiment of an ultrasound system 20 is shown, having transducers 280 adapted and / or configured to treat tissue at multiple depths of focus 278. In one embodiment, the depth of focus 278 is the distance between the transducer 280 and the target tissue for treatment. In one embodiment, the depth of focus 278 is fixed for a given transducer 280. In one embodiment, the depth of focus 278 is variable for a given transducer 280. In one embodiment, the transducer 280 is configured to treat simultaneously at multiple depths (e.g., 1.5 mm, 3.0 mm, 4.5 mm, or other depths) below the skin surface.

[0084] refer to Figure 4 As illustrated in the diagram, module 200 may include a transducer 280 that can emit energy through an acoustically transparent member 230. In various embodiments, depth may refer to depth of focus 278. In one embodiment, transducer 280 may have an offset distance 270, which is the distance between the surfaces of transducer 280 and acoustically transparent member 230. In one embodiment, depth of focus 278 of transducer 280 is a fixed distance from the transducer. In one embodiment, transducer 280 may have a fixed offset distance 270 from the transducer to acoustically transparent member 230. In one embodiment, acoustically transparent member 230 is adapted and / or configured to be located at a position on module 200 or ultrasound system 20 to contact skin surface 501. In various embodiments, the amount by which depth of focus 278 exceeds offset distance 270 corresponds to treatment at a target area located at tissue depth 279 below skin surface 501. In various embodiments, when the ultrasound system 20 is positioned to physically contact the skin surface 501, the tissue depth 279 is the distance between the acoustically transparent member 230 and the target region, measured as the distance from the portion of the cane 100 or module 200 in contact with the skin (with or without acoustic coupling gel, medium, etc.) and the depth in the tissue of the target region from that point of contact on the skin surface. In one embodiment, the depth of focus 278 may correspond to the sum of the offset distance 270 (measured to the surface of the acoustically transparent member 230 in contact with the coupling medium and / or skin 501) and the tissue depth 279 below the skin surface 501 of the target region. In various embodiments, the acoustically transparent member 230 is not used.

[0085] Coupling components may include various substances, materials, and / or devices to facilitate coupling of transducer 280 or module 200 to the region of interest. For example, coupling components may include acoustic coupling systems adapted and / or configured for acoustic coupling of ultrasonic energy and signals. Acoustic coupling systems with possible connections (e.g., manifolds) can be used to couple sound to the region of interest, providing liquid or fluid-filled lens focusing. Coupling systems can facilitate this coupling by using one or more coupling media, including air, gas, water, liquid, fluid, gel, solid, non-gel, and / or any combination thereof, or any other medium that allows signal transmission between transducer 280 and the region of interest. In one embodiment, one or more coupling media are provided within the transducer. In one embodiment, the fluid-filled module 200 contains one or more coupling media within a housing. In one embodiment, the fluid-filled module 200 contains one or more coupling media within a sealed housing, separable from the dry portion of the ultrasonic device. In various embodiments, the coupling medium is used to transmit ultrasonic energy between one or more devices and tissues with a transmission efficiency of 100%, 99% or more, 98% or more, 95% or more, 90% or more, 80% or more, 75% or more, 60% or more, 50% or more, 40% or more, 30% or more, 25% or more, 20% or more, 10% or more, and / or 5% or more.

[0086] In various embodiments, transducer 280 can image and treat the region of interest at any suitable tissue depth 279. In one embodiment, transducer module 280 can provide acoustic power in the range of about 1 W or less, between about 1 W and about 100 W, and greater than about 100 W (e.g., 200 W, 300 W, 400 W, 500 W). In one embodiment, transducer module 280 can provide acoustic power at frequencies of about 1 MHz or less, between about 1 MHz and about 10 MHz (e.g., 1.75 MHz, 3 MHz, 4 MHz, 4.5 MHz, 7 MHz, 10 MHz), and greater than about 10 MHz. In one embodiment, module 200 has a depth of focus 278 for treating at a tissue depth 279 of about 4.5 mm below the skin surface 501. In one embodiment, module 200 has a depth of focus 278 for treating at a tissue depth 279 of about 3 mm below the skin surface 501. In one embodiment, module 200 has a depth of focus 278 for treatment at a tissue depth 279 of approximately 1.5 mm below the skin surface 501. Some non-limiting embodiments of transducer 280 or module 200 may be adapted and / or configured to deliver ultrasound energy at tissue depths ranging from 1.5 mm, 3 mm, 4.5 mm, 6 mm, 7 mm, less than 3 mm, between 3 mm and 4.5 mm, between 4.5 mm and 6 mm, greater than 4.5 mm, greater than 6 mm, and so on, as well as at 0-3 mm, 0-4.5 mm, 0-6 mm, 0-25 mm, 0-100 mm, and at any depth therein. In one embodiment, ultrasound system 20 provides two or more transducer modules 280. For example, a first transducer module may apply treatment at a first tissue depth (e.g., approximately 4.5 mm), a second transducer module may apply treatment at a second tissue depth (e.g., approximately 3 mm), and a third transducer module may apply treatment at a third tissue depth (e.g., approximately 1.5-2 mm). In one embodiment, at least some or all of the transducer modules may be adapted and / or configured to apply treatment at approximately the same depth.

[0087] In various embodiments, varying the number of focal points used in the ultrasound procedure (e.g., having a tissue depth 279) can be advantageous because it allows treatment of the patient at different tissue depths, even if the focal depth 278 of the transducer 270 is fixed. This can provide synergistic results and maximize the clinical outcomes of individual treatment sessions. For example, treatment at multiple depths below a single surface area allows for a larger overall volume of tissue treatment, resulting in enhanced collagen formation and tightening. Additionally, treatment at different depths affects different types of tissue, thereby producing different clinical effects that together provide an enhanced overall cosmetic outcome. For example, surface treatment can reduce the visibility of wrinkles, and deeper treatment can induce more collagen growth. Similarly, treatment at various locations at the same or different depths can improve overall treatment outcomes.

[0088] While treating a subject at different locations within a single treatment session may be advantageous in some embodiments, sequential treatment over time may be beneficial in other embodiments. For example, a subject may be treated within the same surface area, at a first depth at a first time, at a second depth at a second time, and so on. In various embodiments, the time can be on the order of nanoseconds, microseconds, milliseconds, seconds, minutes, hours, days, weeks, months, or other time intervals. New collagen generated by the first treatment may be more sensitive to subsequent treatments, which may be desirable for some indications. Alternatively, multi-depth treatment within the same surface area within a single treatment session may be advantageous because treatment at one depth can synergistically enhance or complement treatment at another depth (due to, for example, enhanced blood flow, stimulation of growth factors, hormone stimulation, etc.). In several embodiments, different transducer modules provide treatment at different depths. In one embodiment, a single transducer module can be tuned or controlled for varying depths. Safety features that minimize the risk of selecting the wrong depth can be used in conjunction with a single-module system.

[0089] In several embodiments, a method is provided for treating lower facial and neck regions (e.g., the submental region). In several embodiments, a method is provided for treating (e.g., softening) mentolabial wrinkles. In other embodiments, a method is provided for treating eye regions (e.g., cheekbone bags, treating infraorbital laxity). By treating at variable depths, several embodiments achieve improvement in upper eyelid laxity and periorbital line and texture. Optimal clinical results (e.g., softening, tightening) can be achieved by treating at different locations in a single treatment session. In several embodiments, the treatment methods described herein are non-invasive cosmetic procedures. In some embodiments, the methods can be used in conjunction with invasive procedures, such as surgical cosmetic procedures or liposuction, where skin tightening is desired. In various embodiments, the methods can be applied to any part of the body.

[0090] In one embodiment, the transducer module 200 allows treatment sequences at or below the skin surface at a fixed depth. In one embodiment, the transducer module allows treatment sequences at one, two, or more variable or fixed depths below the dermis. In several embodiments, the transducer module includes a movement mechanism adapted and / or configured to guide ultrasound treatment at a fixed focal depth in sequences of individual thermal injuries (hereinafter referred to as “thermal coagulation points” or “TCPs”). In one embodiment, the sequence of individual TCPs has treatment intervals ranging from about 0.01 mm to about 25 mm (e.g., 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 5 mm, 10 mm, 20 mm, and any numerical range thereof), with the interval dithering varying from 1% to 50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, and any range thereof). For example, the interval can be 1.1 mm or less, 1.5 mm or more, between about 1.1 mm and about 1.5 mm, etc. In one embodiment, individual TCPs are discrete. In one embodiment, individual TCPs are overlapping. In one embodiment, the motion mechanism is adapted and / or configured to be programmed to provide a variable interval between individual TCPs. In one embodiment, jitter may be adapted and / or configured to provide a variable interval between individual TCPs. In several embodiments, the transducer module includes a motion mechanism adapted and / or configured to guide ultrasound therapy in a sequence such that TCPs are formed in a linear or substantially linear sequence separated by treatment distances. For example, the transducer module may be adapted and / or configured to form TCPs along a first linear sequence and a second linear sequence separated by treatment distances from the first linear sequence. In one embodiment, the treatment distance between adjacent linear sequences of individual TCPs is in the range of about 0.01 mm to about 25 mm. In one embodiment, the treatment distance between adjacent linear sequences of individual TCPs is about 0.01 mm to about 50 mm. For example, the treatment distance may be 2 mm or less, 3 mm or more, between about 2 mm and about 3 mm, etc. In several embodiments, the transducer module may include one or more movement mechanisms 400 adapted and / or configured to guide ultrasound therapy in a sequence such that TCP is formed in a linear or substantially linear sequence of separate thermal damage at treatment distances from other linear sequences. In one embodiment, therapy is applied in a first direction 290 (e.g., push). In one embodiment, therapy is applied in the opposite direction to the first direction 290 (e.g., pull). In one embodiment, therapy is applied in both the first direction 290 and the direction opposite to the first direction (e.g., push-pull). In one embodiment, the treatment distances of the separated linear or substantially linear TCP sequences are the same or substantially the same.In one embodiment, for various adjacent linear TCP sequence pairs, the treatment distances for separating linear or substantially linear TCP sequences are different or substantially different.

[0091] In one embodiment, first and second removable transducer modules are provided. In one embodiment, each of the first and second transducer modules is adapted and / or configured for ultrasound imaging and ultrasound therapy. In one embodiment, the transducer module is adapted and / or configured for therapy only. In one embodiment, the imaging transducer may be attached to a handle or cane of a probe. The first and second transducer modules are adapted and / or configured for interchangeably coupling to a cane. The first transducer module is adapted and / or configured to apply ultrasound therapy to a first tissue layer, while the second transducer module is adapted and / or configured to apply ultrasound therapy to a second tissue layer. The second tissue layer is at a different depth than the first tissue layer.

[0092] like Figure 3 As shown, in various embodiments, module 200 provides, through controlled operation of the control system, the emitted energy 50 is delivered with appropriate depth of focus 278, distribution, timing and energy level to achieve the desired therapeutic effect of controlled thermal damage to treat at least one of the epidermis 502, dermis 503, fat layer 505, SMAS layer 507, muscle layer 509 and / or hypodermis 504. Figure 3 One embodiment is shown that corresponds to a depth used for treating muscles. In various embodiments, this depth can correspond to any tissue, tissue layer, skin, epidermis, dermis, hypothalamus, fat, SMAS, muscle, blood vessels, nerves, or other tissue. During operation, module 200 and / or transducer 280 can also mechanically and / or electronically scan along surface 501 to treat extended areas. Before, during, and after delivering ultrasound energy 50 to at least one of the epidermal layer 502, dermal layer 503, hypothalamus 504, fat layer 505, SMAS layer 507, and / or muscle layer 509, monitoring of the treatment area and surrounding structures can be provided to plan and evaluate results and / or provide feedback to controller 300 and user via a graphical interface.

[0093] In one embodiment, the ultrasound system 20 generates guided and focused ultrasound energy beneath surface 501. This controlled and focused ultrasound energy 50 creates thermal coagulation points or regions (TCPs) 550. In one embodiment, the ultrasound energy 50 creates voids in subcutaneous tissue. In various embodiments, the emitted energy 50 targets the tissue beneath surface 501, cutting, ablating, coagulating, microablating, manipulating, and / or causing TCPs 550 in the tissue portion 10 beneath surface 501 at a specified depth of focus 278. In one embodiment, during a treatment sequence, transducer 280 moves at specified intervals 295 in the direction indicated by the arrow labeled 290 to create a series of treatment regions 254, each receiving the emitted energy 50 to create one or more TCPs 550. In one embodiment, the arrow labeled 291 indicates an axis or direction orthogonal or parallel to arrow 290, and the intervals of the TCPs 550 indicate that the TCPs may be spaced apart orthogonal or parallel to the direction of movement of transducer 280. In some embodiments, the orientation of the spaced TCP can be set at any angle from 0 to 180 degrees relative to arrow 290. In some embodiments, the orientation of the spaced TCP can be set at any angle from 0 to 180 degrees based on the orientation of the polarization region on transducer 280.

[0094] In various embodiments, the transducer module may include one or more transducer elements. The transducer elements may include piezoelectric active materials such as lead zirconate titanate (PZT), or any other piezoelectric active material such as piezoelectric ceramics, crystals, plastics, and / or composites, as well as lithium niobate, lead titanate, barium titanate, and / or lead metaniobate. In various embodiments, as an addition to or alternative to the piezoelectric active material, the transducer module may include any other materials adapted and / or configured for generating radiant and / or acoustic energy. In various embodiments, the transducer module may be adapted and / or configured to operate at different frequencies and treatment depths. Transducer properties may be determined by the outer diameter (“OD”) and focal length (F… L ( ) is defined. In one embodiment, the transducer may be adapted and / or configured to have OD = 19 mm and F L = 15mm. In other embodiments, other suitable OD and F can be used. L Values, such as OD less than approximately 19 mm, greater than approximately 19 mm, etc., F LThe transducer module can be adapted and / or configured to apply ultrasound energy at different target tissue depths, such as less than about 15 mm and greater than about 15 mm. As described above, in several embodiments, the transducer module includes a movement mechanism adapted and / or configured to guide ultrasound therapy in a linear or substantially linear sequence of individual TCPs, with treatment intervals between the individual TCPs. For example, the treatment intervals can be about 1.1 mm, 1.5 mm, etc. In several embodiments, the transducer module may also include a movement mechanism adapted and / or configured to guide ultrasound therapy in a sequence such that TCPs are formed in a linear or substantially linear sequence separated by treatment intervals. For example, the transducer module can be adapted and / or configured to form TCPs along a first linear sequence and a second linear sequence with treatment intervals separated from the first linear sequence by about 2 mm to 3 mm. In one embodiment, a user can manually move the transducer module on the surface of the treatment area to generate adjacent linear sequences of TCPs. In one embodiment, the movement mechanism can automatically move the transducer module on the surface of the treatment area to generate adjacent linear sequences of TCPs.

[0095] Aperture spatial frequency analysis and Fourier transform

[0096] In various embodiments, spatial frequency analysis techniques based on Fourier analysis and Fourier optics can be used to improve the efficiency of treatment processes. When there is an impulse response... h(t) The system consists of stimuli x(t) When stimulating, input x(t) and output y(t) The relationship between them is linked by the following convolution function:

[0097] (1)

[0098] In various embodiments, the Fourier transform can be applied to compute the convolution of equation (1). A continuous one-dimensional Fourier transform can be defined as:

[0099] (2)

[0100] Here, f is frequency and t is time. It can be shown that convolution in the time domain is equivalent to multiplication in the frequency domain:

[0101] (3)

[0102] In various embodiments, the Fraunhofer approximation can be used to derive the relationship between the transducer opening or aperture and the resulting ultrasonic beam response. The derivation of the Fraunhofer approximation is found in Joseph Goodman's work. Introduction to Fourier OpticsAs described in (Third Edition, 2004), the entire contents of which are incorporated herein by reference. According to the Fraunhofer approximation, the far-field composite amplitude mode generated by a composite aperture is equal to the two-dimensional Fourier transform of the aperture amplitude and phase. In several embodiments, this relationship in optics can be extended to ultrasound because linear wave equations can be used to represent both light and sound propagation. In the optical and / or ultrasonic cases, the two-dimensional Fourier transform can determine the acoustic pressure amplitude distribution at the transducer's focal point.

[0103] For a focused system, the variable representing depth is... z Focal length can be expressed as z f replace.

[0104] (4a)

[0105] (4b)

[0106] In various embodiments, Fourier optics and Fourier transform identities (some of which are listed in Table 1 below) can be used with ultrasonic transducers to determine the intensity distribution corresponding to the transducer design. For example, rectangular... rect(ax) The Fourier transform of is a sinc function. As another example, the Fourier transform of a two-dimensional circle with uniform amplitude is a first-order Bessel function, which can be expressed as . J 1 .

[0107]

[0108] Table 1

[0109] In several embodiments, the ultrasonic transducer may have a rectangular aperture with suitable dimensions and focal length. In several embodiments, the ultrasonic transducer may have a circular aperture with suitable dimensions and focal length. In one embodiment, the transducer may have a circular aperture with an outer radius of approximately 9.5 mm, an inner diameter of approximately 2 mm, and a focal length of approximately 15 mm. The aperture of the circular transducer can be described as follows:

[0110] (5a)

[0111] (5b)

[0112] For example, in one embodiment, the variable “a” can be approximately 9.5 mm, and the variable “b” in equation (5a) can be approximately 2 mm. Applying a Fourier transform to equation (5a) can provide an estimate of the acoustic pressure distribution at the focal point.

[0113] (6)

[0114] in and With equations (4a) and (4b) f x and f y The same. Equation (6) shows that the acoustic pressure distribution of a transducer with a circular aperture is a first-order Bessel function. In one embodiment, most of the energy is concentrated at the focal point (e.g., 15 mm from the aperture). The width of the main ultrasonic beam and the energy distribution away from the main beam can be expressed as a function of the operating frequency, as shown in equations (4a) and (4b).

[0115] In various embodiments, if the aperture is modulated (e.g., multiplied) by the correct function, two identical or nearly identical beams can be produced at the focal point. In one embodiment, the cosine function can be applied to a circular aperture as follows:

[0116] (7)

[0117] The energy distribution or beam response at the focal point of the modulation aperture in equation (7) is the convolution of the Fourier transforms of two functions of the aperture:

[0118] (8)

[0119] Equation (8) can be simplified to the sum of two independent functions applying the Fourier transform identity of the Dirac delta function (e.g., identity 2 in Table 2):

[0120] (9)

[0121] Equation (9) shows that, compared to the original unmodulated beam, the two beams appearing at the focal point are spatially offset by ± In several embodiments, one or more other modulation functions (e.g., sine functions) may be used to achieve the desired beam response. In several embodiments, the aperture may be modulated to produce more than two focal points. For example, three, four, five, or other focal points may be produced. In several embodiments, the aperture may be modulated such that the focal points are produced sequentially or substantially sequentially rather than simultaneously.

[0122] In several embodiments, the therapeutic transducer module includes a moving mechanism configured to guide ultrasound therapy in a linear or substantially linear sequence of individual TCPs, wherein there is a treatment interval between the individual TCPs. For example, the treatment interval may be about 1.1 mm, 1.5 mm, etc. In several embodiments, the transducer module may also include a moving mechanism configured to guide ultrasound therapy in a sequence such that TCPs are formed in a linear or substantially linear sequence separated by treatment intervals. For example, the transducer module may be configured to form TCPs along a first linear sequence and a second linear sequence with treatment intervals separated from the first linear sequence by about 2 mm to 3 mm. According to equation (9), if the aperture is modulated by a cosine and / or sine function of the desired spatial frequency, simultaneous or substantially simultaneous splitting of the ultrasound beams can be achieved at the focal point (or before the focal point). In one embodiment, two simultaneously or nearly simultaneously focused beams separated by a treatment interval of about 1.1 mm can be generated in a linear or substantially linear sequence. At an ultrasound frequency of 7 MHz, the wavelength of ultrasound in water is... It is approximately 0.220 mm. Therefore, the spatial frequency at the focal point is... and Represented as:

[0123] (10a)

[0124] (10b)

[0125] To separate the two focal points by approximately 1.1 mm, the spatial frequency used for the modulation aperture is then calculated as follows. Using identities 3 and 4 in Table 2, the Fourier transform of the sine or cosine function is the Dirac delta function with the following parameters:

[0126] (11a)

[0127] In one embodiment, when the parameter is 0, equation (11a) can be solved. k x :

[0128] (11b)

[0129] also, x o It can be replaced with half of the separation distance (e.g., 1.1 mm):

[0130] (11c)

[0131] In several embodiments, a transducer having a circular aperture that emits ultrasonic energy at various operating frequencies can be modulated using sine and / or cosine functions of the spatial frequencies listed in Table 2. The modulation aperture of the transducer can generate simultaneous or substantially simultaneous split beams using two focal points with different separation distances, as shown in Table 2. In one embodiment, the transducer may have an OD of approximately 19 mm and a focal length of approximately 15 mm.

[0132]

[0133] Table 2

[0134] As shown in Table 2, in several embodiments, for a given focal separation distance, the spatial frequency of the aperture modulation function increases with increasing ultrasonic operating frequency. Additionally, the spatial frequency increases with increasing desired focal separation distance.

[0135] In one embodiment, a higher spatial frequency can cause amplitude transitions in the aperture to occur more rapidly. Rapid amplitude changes in the aperture can reduce aperture efficiency due to transducer processing limitations, as the amount of sound pressure generated in different portions of the aperture may differ. In one embodiment, using spatial frequencies to simultaneously or nearly simultaneously split the beams can reduce the total focal gain of each beam. As shown in equation (9), the field pressure at the focal point of each beam is reduced by half compared to an unmodulated beam. In one embodiment, the sound pressure or ultrasonic intensity from the aperture can be increased to obtain similar or substantially similar intensity at the focal plane. However, in one embodiment, increasing the pressure at the aperture may not be limited by system and / or transducer processing limitations. In one embodiment, increasing the pressure at the aperture can increase the total intensity in the near field, which can increase the likelihood of overheating the treatment area tissue located before the focal point. In one embodiment, the possibility of additional heating of the tissue before the focal point can be limited or eliminated by using a lower ultrasonic treatment frequency.

[0136] In one embodiment, applying the aperture modulation function as shown in equation (7) results in two simultaneous or nearly simultaneous ultrasonic beams at the focal point. In various embodiments, the ultrasonic beams can be split multiple times, such as third, fourth, fifth, etc., to generate multiple simultaneous or nearly simultaneous beams. In one embodiment, four equally spaced beams along one dimension can be generated by modulating or multiplying the aperture by two independent spatial frequencies:

[0137] (12a)

[0138] (12b)

[0139] As shown in equation (12b), an unmodulated beam at the focal point can be generated at four different locations along the x-axis. In one embodiment, a constant or DC term C1 can be added to the amplitude modulation function to maintain the energy placement at the original focal location:

[0140] (13a)

[0141] (13b)

[0142] In one embodiment, due to system, material, and / or tissue limitations, the aperture modulation of equations (12) and (13), whereby the beam can be placed at multiple locations simultaneously or nearly simultaneously, may have limited applicability. In one embodiment, the frequency of ultrasound therapy can be adjusted (e.g., reduced) to limit and / or eliminate the possibility of heating tissue in the treatment area prior to the focal plane, due to the possibility of heating such tissue. In one embodiment, nonlinear techniques can be applied at the focal plane to limit and / or eliminate the possibility of heating tissue prior to the focal plane. In one embodiment, the sound pressure or ultrasound intensity from the aperture can be increased to obtain similar or substantially similar intensity at the focal plane.

[0143] In various embodiments, if the amplitude and phase functions at the aperture are separable, then the sound pressure function U(x 1 , y 1 ) The two-dimensional Fourier transform can be expressed as x and y The product of the one-dimensional Fourier transforms of two functions. In various embodiments, it may be advantageous to generate multiple TCPs in a linear or approximately linear sequence, as well as multiple linear sequences simultaneously or nearly simultaneously.

[0144] Frequency-modulated electronic dithering multibeam splitting aperture

[0145] In various embodiments, Table 2 shows the aperture spatial frequency used to achieve a specific distance between two simultaneous focal points for a given operating frequency (e.g., 4 MHz, 7 MHz, 10 MHz in various embodiments). Equation (11c) shows that the separation distance between focal points is also a function of the operating frequency. For example, in one embodiment, the aperture spatial frequency (k x Fixed at 1.0mm -1 Furthermore, it allows for variations in the operating frequency. Equation 11c can be rewritten to show how the focus separation distance can be modulated by the operating frequency.

[0146] s = (k x z f v c) / (π f op (14)

[0147] Where k x It is spatial frequency, measured in mm. -1 , z f It is the focal depth of the aperture, in mm, v c It is the speed of ultrasound in a propagation medium (such as water), and the unit is mm / s. sec, and f op This is the operating frequency of the aperture, measured in MHz. In one embodiment, the following substitution is made in equation 11c:

[0148] = v c / f op (15)

[0149] As shown in equation (14), the separation distance of the focus is a function of the operating frequency. Furthermore, the rate of change of the separation distance with respect to the operating frequency is:

[0150] ds / df op =-(k x z f v c ) / (πf op 2 (16)

[0151] Equation (16) shows that the separation distance decreases as the operating frequency increases. Table 3 (below) shows the rate of change of the separation distance as a function of the operating frequency for different spatial frequencies (e.g., 4 MHz, 7 MHz, 10 MHz in various embodiments).

[0152]

[0153] Table 3

[0154] As shown in Table 3, the focal point becomes closer as the operating frequency increases and farther as the operating frequency decreases, without changing the phase or mechanically moving the transducer. This is a unique method of electronically moving the beam to extend energy without relying on heat conduction in the tissue. Benefits include a reduction or minimization of maximum temperature and an increase in the thermal coagulation volume of the lesion without requiring additional system channels.

[0155] The amount of shift from the master operating frequency can be determined using equation (14). In one embodiment, the master operating frequency of the aperture is 5 MHz and the focal length is 15 mm. In some embodiments, the operating frequency is referred to as the aperture center frequency. In one embodiment, the operating frequency is 5 MHz. In one embodiment, Figure 5Table 4 shows designs with different spatial frequencies (k) for a center frequency of 5MHz. x = 0.5, 1.0, 1.5, 2.0, in mm -1 The aperture focal separation is calculated. It also calculates the focal spread from the center frequency of 5 MHz. According to one embodiment, the spacing decreases for higher frequencies relative to 5 MHz and increases for lower frequencies relative to 5 MHz.

[0156] Figure 6 The intervals between all operating frequencies for different aperture spatial frequencies are shown. For example... Figure 6 As shown, the separation distance increases as the frequency decreases.

[0157] In one embodiment, the separation distance is relative to a frequency of 5 MHz. In one embodiment, one method for estimating electronic jitter from frequency modulation can be determined by referencing all shifts in the initial separation at 5 MHz. Figure 7 As shown, the separation distance between focal points can be easily varied by more than 1 mm.

[0158] In various embodiments, the range of possible operating frequencies from an aperture can be described based on the transducer bandwidth. In one embodiment, a larger transducer bandwidth results in an aperture with a wider range of operating frequencies. The transducer bandwidth can be described as a percentage of the aperture's center frequency by locating the frequency at which the emission intensity decreases to -3 dB of the peak emission intensity. In one embodiment, the -3 dB high frequency is specified as f for the emission response of the transducer aperture. -3db,H Furthermore, the -3dB low frequency is specified as f. -3dB, L The -3dB center frequency, in [MHz], is described as follows:

[0159] f -3dB，center = (f -3dB，H + f -3dB，L ) / 2 (17)

[0160] -3dB percentage bandwidth is described as:

[0161] BW -3dB = 100%* (f -3dB，H -f -3dB，L ) / ((f -3dB，H +f -3dB，L ) / 2) (18)

[0162] In some embodiments, the range of possible operating frequencies within an aperture can be increased by using (but not limited to) a backing layer, a matching layer, multiple piezoelectric layers, electrical matching, piezoelectric composites, and / or single-crystal piezoelectric ceramics. In one embodiment, the range of possible separation distances increases with increasing transducer bandwidth. Table 5 (below) shows how the focus extension based on percentage bandwidth can change if the aperture center frequency is 5 MHz. For 0.5 mm -1 1.00mm -1 1.50mm -1 2.00mm -1 The spatial frequencies and focal separation distances at 5MHz are 0.72mm, 1.43mm, 2.15mm, and 2.86mm, respectively. If the spatial frequency at the aperture is 1.50mm... -1 Furthermore, if the transducer bandwidth is 60%, the separation distance between focal points changes by 1.42 mm, which is the distance of the lateral resolution of the beam at frequencies greater than 5 MHz.

[0163] Additional extension from the 5MHz center frequency, in [mm]

[0164]

[0165] Table 5

[0166] In one embodiment, the depth of field, as well as the lateral resolution and focus gain, will change with the frequency. In another embodiment, the depth of field, lateral resolution, and focus gain will not change with the frequency. Therefore, in one embodiment, the intensity at the aperture can be varied according to a heating rate target. Moreover, in some embodiments, it may be advantageous to simultaneously transmit multiple operating frequencies to expand the energy immediately or nearly immediately. For example, the emission excitation of the aperture may include excitations at 1.75 MHz, 4 MHz, 5 MHz, and 6 MHz, all simultaneously.

[0167] Multiple focal points are achieved by changing the aperture spatial frequency.

[0168] As shown in Equation 14, the higher the spatial frequency of the aperture, the greater the separation distance between the focal points. In one embodiment, the aperture has a spatial frequency k... x Polarization. By connecting separate electrically excited channels capable of modifying the phase to 0 degrees or 180 degrees, the spatial frequency can be easily doubled or reduced to zero, such as... Figure 8 As illustrated in the embodiment. For example, if the phase on channels 1 to 16 is 0 degrees, then the aperture spatial frequency is k. x In an embodiment, when the phase on each channel changes from 0 degrees to 180 degrees such that odd-numbered channels are at 0 degrees and even-numbered channels are at 180 degrees, the spatial frequency at the aperture is ½k. xIn an embodiment, if the phase repeats every two channels such that channels 1 and 2 are 0 degrees and channels 3 and 4 are 180 degrees, and so on, then the spatial frequency at the aperture is 0. If channel 1 is 0 degrees, channel 2 is 180 degrees, channel 3 is 180 degrees, channel 4 is 0 degrees, and so on, then the spatial frequency at the aperture is 2kHz. x In this case, seven unique focal points can be generated, as shown in Table 4 (in...). Figure 5 If the aperture center frequency is 5MHz and the aperture frequency is 0mm... -1 0.5mm -1 1.0mm -1 or 2.0mm -1 Any of these values ​​corresponds to separation distances of 0 mm, 0.72 mm, 1.43 mm, and 2.86 mm, resulting in seven distinct focal positions with a separation of 0.36 mm. In various embodiments, an intermediate phase between 0 degrees and 180 degrees further allows the two focal points to tilt, enabling the generation of a focal line at the focal plane. Ultimately, the tilt, modulation of the focal positions, and frequency modulation can heat and potentially solidify the entire line to a length of approximately 2.86 mm.

[0169] In one embodiment, the polarized ceramic has a 2k x Spatial frequencies, such as Figure 9 As shown in the diagram. In this case, each electrical channel covers two polarization regions in the ceramic (e.g., piezoelectric ceramic). If channels 1 to 8 have the same electrical phase, the spatial frequency of the aperture is 2kHz. x If the phase alternation results in odd-numbered channels having 0 degrees of phase and even-numbered channels having 180 degrees of phase, then the spatial frequency of the aperture is k. x In one embodiment, this configuration, where only two phases are possible on a channel, enables four distinct focal points. In various embodiments, if additional phases are permissible, the two focal points can be tilted to many different focal positions. This configuration limits the number of electronic channels required to obtain multiple focal positions.

[0170] In several embodiments, the treatment system utilizes multiple treatment channels to achieve electronic focusing and / or redirection. For example, a treatment system utilizing multiple treatment channels for electronic focusing and / or redirection allows for faster electronic jitter to produce more thermal coagulation using the same energy as other treatment devices, or to produce equal thermal coagulation using electronic jitter with less energy than other treatment devices. This technology broadens the balance between efficacy and comfort offered by the device. In addition to electronic jitter, multiple treatment channels can also shift the beam to different depth positions; for example, two conventional transducers, such as DS7-4.5 (7MHz at a depth of 4.5mm) and DS7-3.0 (7MHz at a depth of 3.0mm), can be replaced by a single device that moves between two different depths.

[0171] In one embodiment, a transducer 280 (e.g., a ring array) having multiple treatment channels 281 connected to move the beam axially typically generates TCP 550 first at a deeper depth and then moves to a shallower depth. In another embodiment, TCP 550 is generated at a shallow depth and then at a deeper depth below the skin surface. This sequential generation of TCP 550 will result in prolonged treatment time. For example, in one embodiment, if the time used for deep TCP 550 is t deep And the time used for shallow TCP 550 is t shallow The total treatment time for two TCP 550s is the sum of the two treatment times, t deep Add t shallow In one embodiment, the total treatment time is reduced by using a signal mixing technique to simultaneously form multiple (two or more) TCP 550s, wherein the signal mixing technique uses signal apodization (masking) and phase control at each channel. In one embodiment, the total treatment time is t deep and t shallow Maximum value:

[0172] Treatment time, conventional method: t treatment = t deep + t shallow

[0173] Treatment time, signal mixing: t treatment = max(t deep , t shallow )

[0174] In one embodiment, the ring array design 280 enables electronic movement of the treatment beam in depth (e.g., by changing the depth of the TCP 550 beneath the skin surface). In one embodiment, the transducer 280 includes eight treatment channel ring transducer elements 281 with a fixed mechanical focus. Figure 10A top view of one embodiment of the ceramic ring array design 280 is shown, in which the imaging transducer 285 is located at the center of the bowl. In this embodiment, the therapeutic ring transducer 280 has eight rings identified as Tx0 to Tx7, corresponding to element 281.

[0175] transducer

[0176] In one embodiment, transducer 280 is spherically focused to one or more points. In one embodiment, transducer 280 is cylindrically focused to one or more lines. Various embodiments of transducer 280 include a flat piezoelectric element with a lens. In various embodiments, transducer 280 includes a convex side 282 and a concave side 283. In various embodiments, transducer 280 includes a convex side 282 and a concave side 283, which have the characteristics of providing variable depth, variable spacing, variable focal length positioning, and having any one or more of one, two, three, four, or more simultaneous focusing areas. In various embodiments, transducer 280 is electrically connected to one or more tuning circuits. The tuning circuits improve the electrical signal between the console and the transducer. In various embodiments, one or more tuning circuits are located in the housing of the transducer, in the connection between the transducer and the console, and / or in the console.

[0177] Figure 11 An embodiment of transducer 280 is shown, the transducer comprising a single element having a convex side 282 and a concave side 283. Figure 12 An embodiment of a transducer 280 is shown, comprising a solid-coated convex side 282 and a strip-shaped concave side 283, wherein the strip includes a first polarization region and a second polarization region, wherein the polarization region is a positive electrode, a negative electrode, or an unpolarized electrode. Figure 12 An embodiment of a transducer 280 is shown, comprising a solid-coated convex side 282 and a strip-shaped concave side 283, wherein the strip comprises a first region and a second region, and the regions may or may not include a coating. In one embodiment, a single electrode is disposed on the convex surface, and a polarization strip on the concave surface connects to two channels (e.g., Figure 12 The stripes can be alternated to split the beam or include only one phase to simulate a conventional transducer. This will allow a single transducer to simulate the processing of the DS4-4.5S and DS4-4.5, thus enabling the generation of three lines with a single transducer placement.

[0178] Figure 13 An embodiment of a transducer 280 is shown, comprising a strip-shaped convex side 282 and a solid-coated concave side 283, wherein the strip includes a first polarization region and a second polarization region, wherein the polarization region is a positive electrode, a negative electrode, or unpolarized. Figure 13An embodiment of a transducer 280 is shown, comprising a strip-shaped convex side 282 and a solid-coated concave side 283, wherein the strip comprises a first region and a second region, wherein the regions may or may not include a coating. In various embodiments, the strip is electrically connected to one or more channels. In one embodiment, odd-numbered strips are connected to the first channel and even-numbered strips are connected to the second channel. In one embodiment, the first channel is held at 0°, while the second channel alternates between 0° and 180° (or vice versa). Focused ultrasonic energy from the first channel is held at a single central location, and focused ultrasonic energy from the second (alternating) channel produces two spaced-apart focused regions. The focused ultrasonic energy from the first (constant) and second (alternating) channels together produces three simultaneous TCPs. In one embodiment, a single electrode is disposed on the concave surface, and a polarized strip on the convex surface is connected to two channels (e.g., Figure 13 The stripes can be alternated to split the beam or include only one phase to simulate a conventional transducer. This will allow a single transducer to simulate the processing of DS4-4.5S and DS4-4.5, and thus generate three lines with a single transducer placement.

[0179] Figure 14 An embodiment of a transducer 280 is shown, comprising a strip-shaped convex side 282 and a strip-shaped concave side 283, wherein the strip includes a first polarization region and a second polarization region, wherein the polarization region is positive, negative or unpolarized, and wherein the strip-shaped regions are rotated relative to each other at an orientation of about 90 degrees. Figure 14 An embodiment of a transducer 280 is shown, comprising a strip-shaped convex side 282 and a solid-coated concave side 283, wherein the strip comprises a first region and a second region, wherein the regions may or may not include a coating, and wherein the strips are rotated about 90 degrees relative to each other.

[0180] Figure 15 An embodiment of a transducer 280 is shown, comprising a strip-shaped convex side 282 and an annular concave side 283, wherein the strip includes a first polarization region and a second polarization region, wherein the polarization region is a positive electrode, a negative electrode, or an unpolarized electrode. Figure 15 An embodiment of a transducer 280 is shown, comprising a strip-shaped convex side 282 and an annular concave side 283, wherein the strip comprises a first region and a second region, wherein the regions may or may not have a coating.

[0181] Figure 16 An embodiment of a transducer 280 is shown, comprising an annular convex side 282 and a strip-shaped concave side 283, wherein the strip includes a first polarization region and a second polarization region, wherein the polarization region is a positive electrode, a negative electrode, or an unpolarized electrode. Figure 16 An embodiment of a transducer 280 is shown, comprising an annular convex side 282 and a strip-shaped concave side 283, wherein the strip includes a first region and a second region, and the regions may or may not include a coating.

[0182] In some embodiments, the system includes various features that exist as a single feature (as opposed to multiple features). For example, in one embodiment, the system includes, substantially includes, or comprises a single ultrasound transducer element adapted to provide two simultaneous treatment areas via vibration. In alternative embodiments, multiple features or components are provided.

[0183] Simultaneous treatment at multiple depths

[0184] In various embodiments, the treatment system is configured to generate multiple microcoagulation zones in the tissue that are separated at equal distances along the mechanical motion line. In various embodiments, the treatment system provides different modules, boxes, or different transducers (e.g., DS4-4.5, DS7-4.5, DS7-3.0, DS10-1.5, DS7-3.0N, DS10-1.5N, or OT4-4.5, OT7-4.5, OT7-3.0, OT10-1.5, where the first number represents the treatment frequency and the second number represents the depth of treatment delivery. The 'N' in the latter two transducers indicates that the device is a narrow transducer, intended for hard-to-reach areas such as around the nose and mouth. The first four transducers can deliver treatment along a 25mm line, while the narrow transducer provides a maximum line length of 14mm). In various embodiments, transducers with ring electrodes and polarized ceramics can achieve frequency jitter in the lateral dimension, electronic jitter in the depth dimension, electronic focusing in the depth dimension, and a single transducer that can simulate DS10-1.5 (10MHz at 1.5mm depth), DS7-3.0 (7MHz at 3.0mm depth), DS7-4.5 (7MHz at 4.5mm depth), and DS4-4.5 (4MHz at 4.5mm depth) in a single transducer. In one embodiment, optional tuning electronics can be used in combination with composite ceramics to enable transducers with ring electrodes and polarized ceramics to achieve frequency jitter in the lateral dimension, electronic jitter in the depth dimension, and electronic focusing in the depth dimension. In various embodiments, one, two, three, or more optional tuning circuits help stabilize the signal between the console and the transducer and can be presented in the transducer housing, between the transducer and the console, or within the console.

[0185] In one embodiment, a full-face treatment transducer delivers 800 treatment threads, involving an operator moving the handpiece along the patient's skin over approximately 70 to 90 minutes. In another embodiment, a single treatment bowl is configured to deliver two treatment threads simultaneously (e.g., DS4-4.5S, DS4-3.0S, OT4-4.5S, or OT4-3.0S), which, based on recent clinical studies, can reduce treatment delivery time by approximately 40%. In various embodiments, the treatment device provides a considerable level of efficacy if operated with the correct energy. In various embodiments, simultaneous treatment reduces overall treatment pain. In one embodiment, simultaneous treatment time is significantly reduced, assuming less overall treatment pain.

[0186] In various embodiments, simultaneous treatment will increase the treatment rate by 10%, 20%, 25%, 30%, 40%, 50%, 60% or more. In various embodiments, simultaneous treatment will reduce the treatment time by 10%, 20%, 25%, 30%, 40%, 50%, 60% or more. In various embodiments, the system is configured to complete the treatment in 60, 50, 40, 30, 20, or 10 minutes or less.

[0187] In one embodiment, the simultaneous treatment system generates two lines, capable of moving the microcoagulation depth at 550° in the thermal coagulation region. In another embodiment, the bandwidth of the treatment transducer is increased, potentially resulting in a device that behaves similarly to two, three, four, five, or six fixed-depth devices. In one embodiment, an 8-channel treatment device is used.

[0188] Figure 17 An embodiment of a transducer 280 is shown, comprising an annular convex side 282 and a strip-shaped concave side 283, wherein the strip includes a first polarization region and a second polarization region, wherein the polarization region is a positive electrode, a negative electrode, or an unpolarized electrode. Figure 17 An embodiment of a transducer 280 is shown, comprising an annular convex side 282 and a strip-shaped concave side 283, wherein the strip includes a first region and a second region, and the regions may or may not include a coating. In one embodiment, the annular array coupled to the transducer enables operation at different depths 279 (e.g., D1, D2, D3, ... D) below the skin surface. NTwo focused ultrasound treatment lines are generated simultaneously at point 283. In one embodiment, the strips on the concave side 283 are alternately polarized (e.g., at 0 degrees and 180 degrees, etc.). In various embodiments, the depth 279 is 1.5 mm, 3.0 mm, 4.0 mm, 4.5 mm, or 7 mm. In one embodiment, D1 = 1.5 mm, D2 = 3.0 mm, and D = 4.5 mm. In various embodiments, depth 279 is any point within the ranges of 0.5 mm, 1.0 mm, 1.5 mm, 2 mm, 3 mm, 4 mm, 4.5 mm, 6 mm, 7 mm, less than 3 mm, between 0.5 mm and 5 mm, between 1.5 mm and 4.5 mm, greater than 4.5 mm, greater than 6 mm, 7 mm, and 0.1 mm-3 mm, 0.1 mm-4.5 mm, 0.1 mm-25 mm, 0.1 mm-100 mm, and any depth therein (e.g., 6 mm, 7 mm, 10 mm, 13 mm, 15 mm, 17 mm). In embodiments, simultaneous treatment at multiple depths creates multiple thermal coagulation regions 550 at different depths 279. Figure 17 Both sides of an embodiment of the simultaneous treatment bowl are shown. On one side of the treatment bowl are strips for performing alternating polarization. In one embodiment, the strip is on the concave side 283. In one embodiment, the strip is on the convex side 282. In one embodiment, after polarization is completed, the electrodes are stripped and a complete electrode is placed across the entire side. In one embodiment, cold silver electrodes may also be used to connect the strips. In one embodiment, the opposite sides of the treatment bowl include concentric rings that may or may not have equal areas. When the correct phase is applied to the treatment bowl, the ring array is able to achieve beam shift in depth.

[0189] In one embodiment, a transducer 280, including an annular convex side 282 and a strip-shaped concave side 283, is configured to generate multi-depth thermal solidification regions 550 at various depths 279, such as Figure 18 (Projected in xyz space). Figure 19 (xz plane) and Figure 20 As shown in the (yz plane). Figure 18A three-dimensional sketch of the microcoagulation points is shown. In one embodiment, two, three, four, or more points may be generated simultaneously. In one embodiment, two points are generated simultaneously. In one embodiment, it is anticipated that a deeper microcoagulation point (e.g., 4.5 mm) will be generated first before moving to the next depth (e.g., 3.0 mm) and then finally to the shallowest depth (e.g., 1.5 mm). In one embodiment, the motion mechanism moves from left to right and from right to left. In one embodiment, the skin temperature can be limited by forming a microcoagulation point at the deepest depth (e.g., 4.5 mm) while moving from left to right and then placing the next depth (e.g., 3.0 mm) while moving from right to left and then completing the treatment with a microcoagulation point at the shallowest depth (e.g., 1.5 mm) while moving from left to right again. Figure 19 The projection of the treatment along the direction (x-axis) and depth (z-axis) of the mechanical motion is shown. Figure 20 The projection of the treatment along the direction (y-axis) and depth (z-axis) of the beam split is shown.

[0190] Figure 21-23 An embodiment of a simultaneous multi-depth treatment device is shown, configured to generate TCP at depths of 1.5 mm, 3.0 mm, and 4.5 mm, wherein the intermediate layer deviates from the deep and shallow depths. In one embodiment, a transducer 280 comprising an annular convex side 282 and a strip-shaped concave side 283 is configured to generate multiple depth thermal coagulation regions 550 at various depths 279, such as Figure 21 (Projected in xyz space). Figure 22 (xz plane) and Figure 23 As shown in the (yz plane). In one embodiment, the length of the TCP may limit the ability to directly stack multiple depths of TCP on top of each other. In one embodiment, a motion mechanism causes TCPs of different depths to be offset from each other. Figure 21 A three-dimensional plot of the offset multi-depth transducer is shown. For Figure 18-20 The similar transfer process described can be applied to Figure 21-23 The embodiments in the text include the ability to deliver microcoagulation points while moving from left to right or right to left to minimize the possibility of any potential damage to the epidermis, dermis, or tissue layer. Figure 22 The projection of the transfer along mechanical motion (x-axis) and depth (z-axis) is shown. This clearly shows the intermediate layers of TCP offset from deep and shallow treatment. Figure 23 The projection of the transmission along the direction (y-axis) and depth (z-axis) of the beam split is shown.

[0191] Figure 24-26Embodiments of a simultaneous multi-depth treatment device are shown, configured to generate TCPs at depths of 1.5 mm, 3.0 mm, and 4.5 mm, wherein the intermediate layer is offset from the shallow depth at varying pitches. In one embodiment, a motion mechanism may be used to match the separation distance between TCPs in a single-line treatment. Figure 24-26 A three-dimensional sketch of simultaneous multi-depth treatment is shown. In this embodiment, a 4.5 mm depth treatment is delivered at one pitch (1.5 mm separation), while 3.0 mm and 1.5 mm depth treatments are delivered at another pitch (e.g., 1.1 mm separation). Although the 1.5 mm and 3.0 mm depth treatments are at the same pitch (e.g., 1.1 mm), the motion mechanism allows for the application of offsets to prevent the stacking of microcoagulation points. Figure 25 The projection of the transfer along mechanical motion (x-axis) and depth (z-axis) is shown. This clearly shows that the intermediate layers of the TCP are offset from the shallow treatments, even though the pitch is the same. Similarly, the deepest treatments are at a slightly larger pitch relative to the other two depths. Figure 26 The projection of the transmission along the direction (y-axis) and depth (z-axis) of the beam split is shown.

[0192] In various embodiments, a transducer 280 includes an annular convex side 282 and a strip-shaped concave side 283 (e.g. Figure 16 and / or Figure 17 (As shown) Figure 25 , 26 The treatment pattern shown in embodiments 280 and / or 29. In an embodiment, when viewed in a projection in xyz space, the transducer 280, having an annular convex side 282 and a strip-shaped concave side 283, produces an intensity peak near the center of the focal region (e.g., in...). Figure 18 and 19 In the middle), each ring in the annular convex side 282 is controlled with amplitude (A) and phase (θ). In this case, simultaneous focusing is generated at one depth based on the strip polarization. To generate simultaneous focusing at each depth, as Figure 18 and 19 As shown, different phases (θ) and different amplitudes (A) are applied to each ring to produce simultaneous focal points at different depths. Different phases allow the two focal points to move to different depths of focus, and different amplitudes allow variations in focal intensity and thus alter the heating rate in the tissue. The separation between two focal points at the same depth along the Y-axis is determined by the frequency, depth of focus, and spatial frequency of the strip (see Equation 14, where s is solved). The transducers can be moved manually or mechanically to precisely space the simultaneous focal points along the X-axis. In one embodiment, the middle ring has an amplitude A1 greater than the next outer ring with an amplitude A2, A2 greater than A3, ... up to the outermost ring with an amplitude A1. nThis produces a wider intensity range and allows for the formation of two simultaneous focal points. The amplitude control allows for variations in beamwidth at both focal points, as well as intensity variations affecting the heating rate.

[0193] In various embodiments, a continuous wavefunction can be used to generate simultaneous focusing zones at different depths below the skin surface, combining the excitation function of the focusing solution with another solution. In one embodiment, a focusing zone (f1) at a first depth (d1) and a second focusing zone (f2) at a second depth (d2) different from the first depth (d1) are generated simultaneously. The two focal points at different depths (d1 and d2) can be generated simultaneously via a linear system that combines the excitation with a single ultrasound transducer. The following shows the two sets of amplitudes and phases required for each focusing zone and depth. Since the two excitations occur at the same frequency, the two excitations on each ring can be combined into one amplitude and one phase. Assuming the excitation on ring 1 for focus #1 is written as:

[0194] x 1,1 (t) = A 1,1 sin( t + 1,1 )

[0195] Suppose the excitation on ring 1 of focus #2 is written as:

[0196] x 1,2 (t) = A 1,2 sin( t + 1,2 )

[0197] in It is 2πf, where f is the frequency and t is the time.

[0198]

[0199] In order to generate two foci simultaneously at two different depths, the two excitations of the first ring must be combined:

[0200] X1(t) = x 1,1 (t) + x 1,2 (t) = A 1,1 sin( t + 1,1 ) + A 1,2 sin( t + 1,2 )

[0201] However, even if this is the necessary excitation on ring 1, it is unclear what the actual amplitude and phase required on the ring are to simultaneously and appropriately excite f1 and f2. To determine this new amplitude of the combined effect ( 1) and new phase ( 1) Apply the following trigonometric identities:

[0202] 1 = sqrt([A 1,1 cos( 1,1 ) + A 1,2 cos( 1,2 )] 2 + [A 1,1 sin( 1,1 ) + A 1,2 sin( 1,2 )] 2 )

[0203] 1 = tan -1 [(A 1,1 sin( 1,1 ) + A 1,2 sin( 1,2 )) / (A 1,1 cos( 1,1 ) + A 1,2 cos( 1,2 ))]

[0204] The new stimulus on ring 1 is:

[0205] X1(t) = 1 sin( t + 1)

[0206] The same process can be applied to other rings to obtain an array solution to simultaneously generate f1 and f2. Similarly, if it is desired to transmit three or more foci simultaneously, the above identities can be repeated until only one excitation and one phase are calculated for each ring. For example, assuming the goal is to generate three foci simultaneously, the initial new amplitude and phase for each ring are calculated based on the amplitude and phase required for focal 1 and focal 2. Next, these new amplitudes and phases are combined with the ring excitation required for focal 3.

[0207] While this method can produce simultaneous focal points, the necessary amplitude may be limited by the saturation of the piezoelectric material and the tissue's ability to absorb increased intensity from surrounding tissue when multiple focal points are generated. These physical limitations must be compared with the temporal advantages of simultaneous focal point generation.

[0208] Figure 27-29 An embodiment of a simultaneous multi-depth treatment device is shown, configured to generate TCP at depths of 1.5 mm, 3.0 mm, and 4.5 mm, wherein the intermediate layer deviates from the shallow depth and the frequency is used to generate different separation distances at each depth. Figure 24-26 In this process, a motion mechanism is used to shift the intermediate depth of the TCP from the deepest and shallowest depths. In various embodiments, the amount of separation between the simultaneously generated TCPs depends on the treatment frequency. In one embodiment, the device is capable of delivering treatment at multiple frequencies (e.g., using a broadband treatment transducer), and the distance between TCPs can be modulated using these frequencies. For example, for... Figure 18 The strip spacing discussed is determined during manufacturing because it is generated through ceramic polarization. Lower frequencies and deeper depths simultaneously produce a wider separation between the resulting TCPs (yz planes). Figure 4 A three-dimensional matrix of TCPs with varying degrees of separation is shown. As the frequency increases at shallower depths and the treatment depth decreases, the distance between the resulting TCPs also decreases. Figure 28 The projection of the transfer along mechanical motion (x-axis) and depth (z-axis) is shown. This clearly shows the offset of the intermediate layers of TCP from shallow and deep treatment, even with the same pitch. Figure 29 The projection of the propagation along the direction (y-axis) and depth (z-axis) of beam splitting is shown. This projection indicates that the interval between TCPs gradually increases with increasing treatment depth, primarily due to variations in depth and frequency during treatment.

[0209] In one embodiment, such as Figure 29 As shown, different intervals can be produced by changing the frequency and depth of focus. For example, Equation 14 is:

[0210] s = (2 k x z f ) / (2 )

[0211] Where s is the interval between two simultaneous focal points at the same depth. This equation shows that focal separation is the depth of focus (z). f ) and a function of frequency (because (This is the speed of sound divided by the frequency). It assumes the same frequency and spatial frequency on the strip are used. This table summarizes the separation at different focal points with a separation of 1.5 mm.

[0212]

[0213] However, if the frequency variation allows for the use of higher frequencies at the shallowest focus, a wider range of separation distances can be achieved:

[0214]

[0215] In various embodiments, different values ​​of w (e.g., w1, w2) can be used to vary the distance or interval. In various embodiments, a continuous wave function can be used to generate simultaneous focusing regions at different depths below the skin surface, combining frequency with Fourier transform. In one embodiment, a focal region (f1) at a first depth (d1) and a second focal region (f2) at a second depth (d2) different from the first depth (d1) are generated simultaneously. The two focal points at different depths (d1 and d2) can be generated simultaneously via a linear system that combines the excitation of a single ultrasound transducer.

[0216]

[0217] where X1 = excitation (A, θ) = A 1,1 sin (w1t- θ 1,1 ) A 1,2 sin (w2t- θ 1,2 This allows for the creation of two simultaneous focal points at different distances.

[0218] In various embodiments, the electrostrictor exhibits piezoelectric behavior when a sufficient DC bias is applied to the material. In one embodiment, the intensity of the piezoelectric behavior is proportional to the acoustic sensitivity. In one embodiment, the electrostrictive material is used with a treatment bowl during manufacturing. In one embodiment, patterning and electrode attachment are performed during manufacturing, but the polarization of the electrostrictor is completed during treatment delivery. For example, in one embodiment, the emission aperture may be as follows: Figure 37 The square wave shown can be masked by modifying the high voltage value. Figure 30 An embodiment of a simultaneous multi-depth treatment device is shown, configured to generate TCPs at depths of 1.5 mm, 3.0 mm, and 4.5 mm, wherein a ring array is coupled to electrostrictors capable of generating multiple pairs simultaneously at different depths. In one embodiment, the electrostrictors change the spatial frequency (e.g., Figure 37 As shown in one embodiment) to provide the generation of a treatment line (e.g. Figure 34(As shown in one embodiment). In one embodiment, the electrostrictor generates a treatment line without employing a mechanical motion mechanism. In one embodiment, the electrostrictor generates a line of motion perpendicular to a mechanical motion mechanism. Therefore, in various embodiments, multidimensional therapy can generate one, two, or more treatment focus areas in various intervals, lines, planes, or three-dimensional space. In some embodiments, the electrostrictor causes ions in the lattice of a piezoelectric transducer to be displaced upon exposure to an external electric field. In various embodiments, Figure 17-29 A fixed polarization mode is used to generate the separation distance between two simultaneously generated TCPs. This is because the polarization mode is generated in the piezoelectric ceramic during the manufacturing process. The spacing between the stripes determines the spacing between TCPs. The greater the distance between the stripes, the closer the TCPs are. In some embodiments, the distance between the stripes cannot be changed after polarization is complete. In one embodiment, as... Figures 30-33 As shown, the electrically insulating material is not involved in polarization; instead, an electrostrictor is used to apply a direct current (DC) voltage during device operation to exhibit piezoelectric behavior that can be used to improve device performance. Figure 30 The front and back of the ceramic bowl (e.g., concave and convex sides) are shown, which are similar to... Figure 17 The embodiment shown. In one embodiment, the annular pattern is on the back side (e.g., the convex side) of the transducer. With Figure 17 Compared to the embodiments described above, the anterior side (patient side, e.g., concave side) differs slightly; for example, the strips appear to be produced with finer pitch. Secondly, the ceramic is not polarized; instead, connections from each individual strip are linked to independent groups of electronics, thereby applying a voltage to the strips to produce an appropriate pattern that generates the separation distance between TCPs. In one embodiment, the voltage varies at a high spatial frequency, resulting in a greater separation distance between TCPs. The electronics allow for alteration of this pattern, so that the distance between TCPs can also be varied. The result is a set of simultaneous TCPs that can be generated through amplitude modulation. It is not necessary to apply a negative or positive voltage to each strip. In some embodiments, shorting the strips to ground can prevent or reduce acoustic excitation. Figure 31 An embodiment of a TCP distribution type that can be generated in three dimensions is shown. In this embodiment, five TCPs are generated at each depth, implemented using three different DC amplitude modulation modes on the strip. Again, based on the motion of the motion mechanism from left to right or from right to left, the modulation mode, and the focusing of the loop, the order can vary within depth 279 or at each depth. The order used is based on the safety tolerance of the epidermis and dermis, as well as any other tissue layers, and the goal of delivering the TCPs as quickly as possible. Figure 32 The projection of the transmission along the mechanical motion (x-axis) and depth (z-axis) is shown. Figure 33The projection of the propagation along the direction (y-axis) and depth (z-axis) of beam splitting is shown. This projection shows five TCPs generated in this plane. Two pairs of TCPs are generated simultaneously, one pair being generated at a time, similar to a conventional transducer. In various embodiments, for Figure 21-29 The techniques discussed in the embodiments are applicable to electrostrictor design.

[0219] Figures 34-36 An embodiment of a simultaneous multi-depth treatment device is shown, configured to generate TCPs at depths of 1.5 mm, 3.0 mm, and 4.5 mm, wherein a ring array coupled to a simultaneous treatment transducer enables the simultaneous generation of two lines at different depths. In one embodiment, the advantage of using an electrostrictor with sufficient stripe length is the ability to generate thermal treatment lines if the mode changes rapidly. Figure 34 An embodiment is shown illustrating three-dimensional TCP lines generated using multiple spatial frequencies of electrostrictor modes at only one depth. Depending on the rate of mode change on the strip, this heating can be varied to produce microcoagulation lines or high-temperature lines, which are tissues used for apoptosis. Figure 35 The projection onto the xz plane is shown, taking into account five lines. Figure 36 The projection onto the yz plane is shown, which illustrates the heating line along the y-axis at a specific depth.

[0220] In one embodiment, Figure 37 This illustrates the different modes that can be generated when the stripe has a fine detail pitch. Figure 37 In the figure, the X-axis represents the distance across the transducer. The Y-axis represents the DC amplitude at the location across the transducer. In various embodiments, various DC signals applied across the transducer can result in different intervals between focal points. In one embodiment, the detail pitch is related to the split distance to be achieved, the operating frequency, and the depth of focus. In various embodiments, the detail pitch is between 0.1 mm and 0.05 mm (e.g., 100 micrometers to 50 micrometers, including 90, 80, 70, 60 micrometers and any of these values). This figure illustrates amplitude modulation that can produce different intervals of micro-coagulation points along the y-axis. Although this figure covers a factor of 2, other modulation modes between the multiples shown are possible. The modulation mode does not have to be an integer of the 1x mode. In various embodiments, even, odd, and zero modes are possible. Finally, the electrostrictor method also provides the possibility of modulation amplitude modes because polarization is a strong function of the DC bias.

[0221] Determining the effectiveness of ultrasound therapy

[0222] In various embodiments, it is desirable to obtain feedback on the effectiveness of ultrasound therapy in producing the desired clinical outcome. Depending on individual morphological differences between patients, the acoustic energy delivered to a volume of tissue in a first patient may produce a first clinical outcome that differs from the second clinical outcome produced when the same amount of acoustic energy is delivered to the same volume of tissue in a second patient. Therefore, systems and methods that help determine the effectiveness of applied ultrasound therapy in different patients can, for example, advantageously improve the efficacy and / or consistency of ultrasound therapy.

[0223] In various embodiments, the desired outcome of the applied ultrasound treatment includes improved skin appearance, such as by reducing skin laxity to achieve one or more of the following beneficial aesthetic and / or cosmetic improvements: face lifting, eyebrow lifting, chin lifting, eye treatment (e.g., cheekbone bags, treatment of infraorbital laxity), wrinkle reduction, fat reduction (e.g., treatment of fat and / or cellulite), cellulite (which may be referred to as female lipodystrophy) treatment (e.g., depressed or non-depressed female lipodystrophy), shoulder improvement (e.g., upper chest), buttock lifting (e.g., buttock tightening), skin tightening (e.g., treating laxity to result in tightening of the face or body, such as the face, neck, chest, arms, thighs, abdomen, buttocks, etc.), scar reduction (e.g., reduction of breast fibrosis), burn treatment, tattoo removal, vein removal, vein reduction, treatment of sweat glands, treatment of hyperhidrosis, sunspot removal, acne treatment, and / or papule reduction. Therefore, in some embodiments, the effectiveness of the applied ultrasound treatment can be determined by measuring the elasticity of the portion of the tissue subjected to ultrasound treatment. In various embodiments, the systems and methods discussed herein are configured to measure the elasticity of a portion of tissue treated via ultrasound therapy. In various embodiments, the elasticity of a portion of tissue treated via ultrasound therapy can be measured in real time while the treatment is being administered.

[0224] In various embodiments, systems and methods are described for measuring the elasticity of a portion of tissue treated via ultrasound imaging, such as constructive shear wave imaging and / or destructive shear wave imaging. Without relying on any particular theory, acoustic energy applied to tissue may cause displacement of one or more portions of the tissue treated via ultrasound. In several embodiments, the response of the tissue as displacement propagates is a shear wave. Without following any particular theory, the shear wave propagates outward from a focal region (e.g., focus, focal line, focal area, etc.), in which the acoustic beam emitted from the transducer is focused. The outwardly propagating shear wave can be reflected from various portions of the tissue. The reflected shear wave can be constructive or destructive with the outwardly propagating shear wave. In constructive shear wave imaging, the characteristics of constructive interference shear waves can be obtained to determine the elasticity of the tissue.

[0225] The embodiments described herein are particularly useful for aesthetic and other procedures in which real-time (manual or automatic) adjustment of treatment parameters is beneficial. In embodiments treating a single subject in a single time period, one or more parameters, such as frequency, power, intensity, duration, and the location of the treatment point (treatment), are modified based on the elasticity of the tissue beneath the skin surface. When multiple thermal coagulation dot lines are generated, parameters can be varied between points and / or lines on the face or body. As an example, if the subject has insufficient elasticity in a certain area, the duration of treatment can be extended (compared to areas of skin with greater elasticity). In some embodiments, one or more of the frequency, power, intensity, duration, or other parameters are changed (increased or decreased) by 10%-30%, 30%-50%, 50%-100%, 2-3 times, 3-5 times or more, and overlapping ranges therein, and in some embodiments, such changes are related to and / or based on elasticity.

[0226] Figure 38 An embodiment illustrating the use of constructive shear wave imaging to determine the elasticity of tissue within an excitation region is schematically illustrated. Figure 38 In one illustrated embodiment, acoustic energy is applied to an excitation region 3801. The excitation region 3801 may correspond to the aperture of an acoustic beam emitted from an ultrasonic transducer. In this illustrated embodiment, the excitation region 3801 is a circular region. In some embodiments, a treatment source corresponds to the excitation region 3801. In some other embodiments, the treatment source may be spaced apart from the excitation region 3801. Shear waves generated from the transducer for tissue excitation converge to a central region 3803 of the excitation region 3801. Various characteristics of the converged shear waves can be obtained, including but not limited to arrival time, peak displacement, rise time, and fall time. Based on the obtained characteristics of the converged shear waves, the elasticity of the tissue within the excitation region 3801 can be determined to determine the effectiveness of ultrasound therapy. A region 3805 within the excitation region 3801 may be referred to as the region of interrogation. Without loss of generality, a shear wave imaging system configured to image the central region 3803 of the excitation region 3801 can be used to obtain the various characteristics of the converged shear waves.

[0227] In various embodiments, incident acoustic energy in the excitation zone is focused at one or more treatment points (e.g., thermal coagulation points or "TCPs"). In one embodiment, in an ultrasound system 20 including a monofocal transducer, shear waves generated by displacement of one or more portions of the tissue being treated via ultrasound propagate outward from the focal zone (or focus), where the acoustic beam emitted from the transducer is focused. In this embodiment with a single treatment point, detecting the constructive interference between the outwardly propagating shear waves and portions of the shear waves reflected from various portions of the tissue may be impractical. Therefore, when ultrasound treatment is performed using a monofocal transducer, using shear wave imaging (e.g., constructive shear wave imaging) techniques to measure the elasticity of the tissue may not be very effective.

[0228] In various embodiments, the ultrasound system 20 includes a transducer providing two or more (e.g., multiple) focus zones and / or treatment points. For example, in various embodiments of the ultrasound system 20, an acoustic beam from a single ultrasound transducer and / or a single ultrasound transducer element can provide two ultrasound treatment points corresponding to the two focus zones. In this implementation, shear waves originating from the two focus zones can converge toward a region between the two focus zones. For example, shear waves originating from the two focus zones can converge toward a central region between the two focus zones. In various embodiments, the central region can correspond to the midpoint between the two focus zones. Shear waves originating from the two focus zones can constructively interfere in the central region between the two focus zones. Various characteristics of the constructive interference between the shear waves originating from the two focus zones can provide information about the tissue elasticity between the two treatment points. As described above, these characteristics may include, but are not limited to, arrival time, peak displacement, rise time, and fall time.

[0229] Figure 39 This illustration schematically demonstrates a method for querying tissue in the region between two ultrasound-excited regions 3901a and 3901b using constructive shear wave imaging. As discussed here, both ultrasound-excited regions 3901a and 3901b can be generated using a single ultrasound transducer. Figure 39 In the illustrated embodiment, the two treatment points coincide with two excitation regions 3901a and 3901b. As described above, shear waves generated from the two excitation regions 3901a and 3901b converge to a central region 3903 between the two excitation regions 3901a and 3901b. An imaging system can be used to obtain various characteristics, including but not limited to the arrival time, peak displacement, rise time, and fall time of the convergent shear wave in the central region 3903, to determine the elasticity of the tissue in the query region 3905.

[0230] from Figure 39Note that query region 3905 does not include treatment points that overlap with excitation regions 3901a and 3901b. Typically, the elasticity of tissue within a treatment point may also vary. Therefore, it is desirable that the query region also include the treatment point. Thus, the ultrasound transducer can be driven at a lower frequency (e.g., using frequency modulation) to separate the excitation region from the treatment point, so that the query region also includes the treatment point. See below. Figure 40 This idea is illustrated and discussed.

[0231] Figure 40 A method for querying tissue in the region between two ultrasound excitation regions 4001a and 4001b is schematically illustrated using constructive shear wave imaging. Using various techniques described in this application, treatment points 4003a and 4003b corresponding to excitation regions 4001a and 4001b are spaced apart from their respective excitation regions 4001a and 4001b. For example, treatment points 4003a and 4003b corresponding to excitation regions 4001a and 4001b can be spaced apart by using frequency modulation of the signal driving the ultrasound transducer. As another example, electronic jitter can be used to separate treatment points 4003a and 4003b from their respective excitation regions 4001a and 4001b. As described above, shear waves generated from the two excitation regions 4001a and 4001b converge to a central region 4005 between the two excitation regions 4001a and 4001b. Imaging systems can be used to obtain various characteristics, including but not limited to the arrival time, peak displacement, rise time and fall time of the converging shear wave in the central region 4005, to determine the elasticity of tissue in the query region 4007, which includes treatment points 4003a and 4003b.

[0232] The method for determining the resilience of treated tissue, which can be used between the two stimulation zones discussed above, can also be applied to determine the resilience of tissue between multiple stimulation zones. This method, which can be used at any time during the formation of two or more treatment points without physically moving the transducer module, can reduce or eliminate the time delay between applying ultrasound therapy and determining the effectiveness of the applied therapy.

[0233] As described above, various embodiments of the ultrasound therapy system 20 discussed herein may include a motion mechanism configured, for example, to move an ultrasound transducer module along a line to form a plurality of treatment points, with constant or variable intervals between successive treatment points. In this embodiment, the method may be configured to determine the elasticity of tissue between two excitation regions (or two treatment points) generated orthogonal to or along the direction of motion.

[0234] Figure 41An embodiment of constructive shear wave imaging with multifocal (e.g., two or more simultaneous focal) transducers is schematically illustrated, which involves modulating the transmission frequencies of excitation pulses—one that shifts the excitation inside the multifocal thermal coagulation point TCP, and another that shifts the excitation outside the multifocal thermal coagulation point TCP. Thus, the differential shear wave velocity can be estimated, particularly around the multifocal TCP. In one embodiment, two constructive shear wave imaging (“CSI”) locations are sequentially formed prior to the delivery of treatment. Figure 41 As shown in the embodiment, CSI position #1 is closest to the imaging beam position and can optionally be formed first. The time to reach maximum displacement along the imaging beam is determined by tracking tissue motion changes along the imaging vector. Next, CSI position #2, which is furthest from the imaging beam position, is formed. Another time to reach maximum displacement along the imaging vector is also determined. Since the distances traveled by the two shear waves and their corresponding times are known, the shear wave velocity through the intended treatment area can be calculated.

[0235]

[0236] This velocity estimate is the incremental shear wave velocity at the expected treatment site. In various embodiments, this concept applies not only to the treatment site but also to areas outside the treatment site to obtain an incremental shear wave velocity estimate across the entire plane (e.g., Figure 41 (As shown). After obtaining the initial shear wave velocity, focused treatment is delivered to the intended treatment site for a specific duration, ranging from microseconds to milliseconds to seconds or even minutes. After treatment delivery, the process of measuring incremental shear wave velocities is repeated. This process repeats itself until the target shear wave velocity of the treated tissue is obtained. In some embodiments, the amount of treatment delivered may be limited to the maximum permissible energy that can be safely delivered to the tissue.

[0237] Using this technique, a curve was obtained showing the shear wave velocity versus treatment time. Figure 42An embodiment of the graph is schematically illustrated, showing the change in shear wave velocity as tissue heats up and coagulates. In one embodiment, after baseline measurements are completed, the tissue is treated, and heating begins. Upon heating, the tissue softens, and the shear wave velocity initially decreases at t1. As treatment continues, the tissue may begin to coagulate, which hardens it and results in an increased shear wave velocity, as shown at t2. Finally, the tissue asymptotically reaches maximum hardness, or maximum shear wave velocity, at t3. While proximity to this maximum shear wave velocity can be used to determine when to stop dosing, the corresponding shear wave velocity curve, based on the rate of change of shear wave velocity, can also be used as feedback to control the heating rate or when to stop treatment delivery. In some embodiments, this method can be advantageous due to its overall responsiveness and ability to predict when to stop treatment.

[0238] In one embodiment, the system or method addresses the issue of y. treat and –y treat The shear wave velocity at that location is averaged. In one embodiment, the phase walking aperture is used only at y treat or –y treat Shear waves are generated at the treatment depth, so shear wave estimates from two different locations are not averaged together. In one embodiment, the CSI beam shape can be modified to generate shear waves over a wider depth range, rather than just localized to the treatment depth, by setting multiple focal points along the beam (as described in previous disclosures) or by reducing the f# of the CSI aperture. In one embodiment, the beat method is used for the treatment beam to continuously generate shear waves as a measurement method.

[0239] Figure 43 Examples of methods or systems for measuring tissue elasticity and therapeutic dosage within a single sweep are illustrated schematically. In various embodiments, a sweep is a single or combined movement (from left to right, from right to left, in-and-out, out-in, out-in) of curves, lines, circles, one-dimensional, two-dimensional, and / or three-dimensional motions. In one embodiment, a first method involves a single measurement before the dose, a single measurement after the dose, wherein a rest time delay may or may not be required at the theoretically optimal time after the dose. The purpose of the first measurement is to select the optimal treatment method. The purpose of the second measurement is to determine the effectiveness of the treatment. The rest time can be used to allow transient tissue changes to subside before the measurement. Effectiveness can be determined by reaching a critical shear wave velocity or percentage change in shear wave velocity from the initial measurement.

[0240] In one embodiment, the second method has the same sequence as the first method, but includes multiple post-treatment elasticity measurements to observe transient elastic changes within the tissue in response to the treatment dose. In addition to observing transient elastic changes as the tissue reaches a new equilibrium state, multiple post-treatment elasticity measurements can be averaged to form a better estimate of the shear wave velocity change. Furthermore, multiple elasticity measurements can be performed above and below the intended treatment area to estimate the extent of the treatment area.

[0241] In one embodiment, a third method is an interleaved sequence in which multiple elasticity measurements are performed between treatment doses, followed by multiple post-treatment elasticity measurements. A pause between the end of an incremental treatment delivery and the start of an elasticity measurement is used to improve the fidelity of the elasticity measurements. This technique is used to determine when to end the treatment delivery based on changes in elasticity. Treatment ends once the elasticity has changed by a certain percentage relative to the baseline measurement, or once a specific level of elasticity change has been reached through heating. A maximum energy threshold is used to limit overdosing and ensure a safe level. The advantage of this technique is that only the necessary energy is used to achieve the desired tissue effect, which improves safety and comfort.

[0242] In one embodiment, optional interleaving of treatment with tissue elasticity measurements may be included or excluded. In one embodiment, a multi-frequency DDS (e.g., an arbitrary waveform generator) is used with a device that excites the treatment transducer at multiple frequencies of the CW and then modulates the amplitude of each excitation such that optional amplitude modulation pushes to generate a shear wave, but the amplitude in the actual treatment area remains unchanged. In one embodiment, modulation of the treatment amplitude occurs if a pre-programmed method based on elasticity measurements (e.g., ramp-up or ramp-down) is used for treatment delivery or feedback.

[0243] Figure 44 An embodiment of elasticity measurement is illustrated when a single outward sweep includes a pre-dose elasticity measurement and subsequent treatment doses at each location. Then, on the return sweep, only elasticity measurement is performed for post-dose evaluation.

[0244] Figure 45 An embodiment of elasticity measurement before and / or after the application of treatment dose is illustrated schematically. The first sweep is a query for pre-treatment tissue elasticity at each TCP location. The subsequent outward sweep applies treatment at each TCP location. The subsequent backward sweep queries for post-treatment elasticity measurements at each TCP location.

[0245] Figure 46An embodiment of CSI shear wave is schematically illustrated, in which the depth of the excitation region and the excitation interval can be controlled. In this embodiment, excitation can be generated at multiple intervals and multiple depths, allowing a wider shear wave to propagate at a controlled angle (θ). Multiple estimates from these excitations at different angles can provide insight into tissue anisotropy, including providing better layer definition. In one embodiment, the longitudinal wave is faster than the shear wave. In one embodiment, measurements are performed in multiple directions (not limited to lateral measurements). Angular encoding allows different velocities to be measured at different angles (muscle layer, tissue, skin boundary, etc.).

[0246] The methods discussed herein for determining the elasticity of tissues undergoing ultrasound treatment can be advantageously used to measure the effectiveness of the applied acoustic energy dose. In various embodiments, the effectiveness of the applied acoustic energy dose can be determined during ultrasound treatment. In some embodiments, the applied dose can be adjusted in real time based on the determined elasticity of the treated tissue to increase the effectiveness of ultrasound treatment. For example, in some embodiments, the applied acoustic energy dose can be slowly increased to a dose that results in a specific elasticity of the treated tissue, which will provide the desired clinical outcome. The acoustic energy dose required to achieve the desired clinical outcome may vary for different patients. Constructive shear wave imaging methods for determining the elasticity of treated tissue advantageously allow for the tailoring of acoustic energy doses to individual patients. Integrating constructive shear wave imaging methods to determine the elasticity of tissues treated with an ultrasound system can also improve safety. For example, in some existing systems, a fixed amount of acoustic energy can be delivered to all patients to achieve clinical efficacy. Depending on the individual patient's morphology, a fixed amount may result in rapid tissue heating and patient discomfort. Monitoring the effectiveness of ultrasound treatment using the constructive shear wave imaging methods described herein allows the dose of applied ultrasound energy to be tailored to the needs of individual patients.

[0247] Various advantages of embodiments of a simultaneous multi-depth treatment device configured to generate multiple TCPs at different depths include generating simultaneous TCPs at multiple depths. In one embodiment, the advantage is the elimination of multiple transducers, thereby reducing transducer switching by the operator. In one embodiment, the advantage is faster treatment time. In one embodiment, the advantage is fewer button presses to deliver the same number of lines. In one embodiment, the advantage is modulating the distance between the simultaneously transmitted TCPs. In one embodiment, the advantage is maintaining the pitch separation of the TCPs at each depth along the mechanical motion line. In one embodiment, the advantage is avoiding pulse stacking at multiple depths. In one embodiment, the advantage is the ability to generate larger coagulation and apoptosis areas. In one embodiment, the advantage is the ability to deliver microcoagulation lines along three dimensions. In one embodiment, the advantage of using an electrostrictor includes generating more than two lines with a single transducer placed on the patient's body. In one embodiment, the advantage of using an electrostrictor is modulating the distance between the simultaneously transmitted TCPs. In one embodiment, the advantage is the ability to modulate attenuate spatial high-frequency harmonics from the simultaneous treatment modulation mode. In one embodiment, the advantage of using an electrostrictor is providing the possibility of adding nulls to the modulation mode.

[0248] The embodiments and examples described herein are illustrative and are not intended to limit the full scope of the compositions and methods describing these inventions. Equivalent variations, modifications, and alterations to some embodiments, materials, compositions, and methods can be made within the scope of the invention, with substantially similar results.

[0249] While the invention is readily adaptable to various modifications and alternatives, specific examples have been shown in the accompanying drawings and described in detail herein. However, it should be understood that the invention is not limited to the specific forms or methods disclosed, but rather encompasses all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. No method disclosed herein needs to be performed in the order stated. The methods disclosed herein include certain actions taken by a practitioner; however, they may also explicitly or implicitly include any third-party instructions regarding these actions. For example, an action such as “coupling the transducer module with the ultrasound probe” includes “instructing the transducer module to be coupled with the ultrasound probe.” The scope of this disclosure also includes any and all overlapping, sub-scopes, and combinations thereof. Languages ​​such as “at most,” “at least,” “greater than,” “less than,” “between,” etc., include the stated numbers. Numbers following terms such as “about” or “approximately” include the stated numbers. For example, “about 25 mm” includes “25 mm.”

Claims

1. A system for measuring the elasticity of a material, the system comprising: An ultrasonic probe, comprising an ultrasonic transducer configured to deliver multiple ultrasonic beams to a material. The material is elastic. The plurality of ultrasonic beams are focused into a plurality of individually spaced focusing regions in the material. Each ultrasonic beam has sufficient acoustic power to generate shear waves originating from the individually separated focal zones and traveling in parallel through the material; An ultrasound imaging system configured to image shear waves originating from at least two of the plurality of individually spaced focal zones and converging toward a region between the plurality of individually spaced focal zones via a query region. as well as The electronic processing system is configured as follows: To obtain the characteristics of the imaged shear wave; and The elasticity of the query region of the material is determined based on the obtained characteristics.

2. The system according to claim 1, wherein, The characteristics of the imaged shear wave include at least one of the shear wave arrival time, the shear wave peak displacement, the shear wave rise time, and the shear wave fall time.

3. The system according to claim 1, wherein, The ultrasonic transducer is configured to deliver the ultrasonic beam to the material by using amplitude modulation to focus the ultrasonic beam at the plurality of individually spaced focusing regions in the material.

4. The system according to claim 3, wherein, The ultrasonic beam is simultaneously focused on the plurality of individually spaced focusing areas in the material.

5. The system according to claim 3, wherein, The ultrasonic beam is sequentially focused on the plurality of individually spaced focusing regions in the material.

6. The system according to claim 1, wherein, The ultrasonic transducer is configured to deliver the ultrasonic beam to the material by using frequency modulation to focus the ultrasonic beam at the plurality of individually spaced focusing regions in the material.

7. The system according to claim 6, wherein, The ultrasonic beam is simultaneously focused on the plurality of individually spaced focusing areas in the material.

8. The system according to claim 6, wherein, The ultrasonic beam is sequentially focused on the plurality of individually spaced focusing regions in the material.

9. The system according to claim 1, wherein, The ultrasonic transducer is configured to deliver the ultrasonic beam to multiple excitation regions of the material corresponding to the multiple individually spaced focusing regions.

10. The system according to claim 9, wherein, The plurality of separately separated focusing regions overlap with the plurality of excitation regions.

11. The system according to claim 9, wherein, The plurality of individually separated focusing regions are separated from the plurality of excitation regions.

12. The system according to any one of claims 1 to 11, further comprising a movable component configured to move the ultrasound probe.

13. The system according to any one of claims 1 to 11, wherein, The materials include organic materials.

14. The system according to any one of claims 1 to 11, wherein, The material includes tissue.

15. The system according to any one of claims 1 to 11, wherein, The material includes skin.

16. The system according to claim 1, wherein, The electronic processing system is configured to determine the elasticity of the material in real time while delivering the ultrasonic beam to the material.

17. The system according to any one of claims 1 to 11, configured for use in a beauty procedure.

18. A method for non-invasively measuring the elasticity of a material, the method comprising: An ultrasonic probe, including at least one ultrasonic transducer, is coupled to a material; Multiple ultrasonic beams are delivered from the ultrasonic transducer to the material; The plurality of ultrasonic beams are focused at a plurality of individually spaced focusing regions in the material; Shear waves originating from the multiple individually separated focal zones propagate in parallel through the material; Image the shear wave originating from at least two of the plurality of individually separated focal regions and converging through a query region toward the region between the at least two of the plurality of individually separated focal regions; To obtain the characteristics of the imaged shear wave; as well as The elasticity of the query region of the material is determined based on the obtained characteristics.

19. The method according to claim 18, wherein, The characteristics of the imaged shear wave include at least one of the shear wave arrival time, the shear wave peak displacement, the shear wave rise time, and the shear wave fall time.

20. The method according to claim 18, wherein, Focusing the ultrasonic beam at multiple individually spaced focal regions in the material includes modulating the amplitude or frequency of one or more signals that drive the ultrasonic transducer.

21. The method according to claim 18, wherein, The ultrasonic beam is simultaneously focused on the plurality of individually spaced focusing areas in the material.

22. The method according to claim 18, wherein, The ultrasonic beam is sequentially focused on the plurality of individually spaced focusing regions in the material.

23. The method according to claim 18, wherein, The ultrasonic beam is delivered to multiple excitation regions of the material corresponding to the multiple individually spaced focusing regions.

24. The method according to claim 23, wherein, The plurality of separately separated focusing regions overlap with the plurality of excitation regions.

25. The method according to claim 23, wherein, The plurality of individually separated focusing regions are separated from the plurality of excitation regions.

26. The method according to any one of claims 18 to 23, further comprising moving the ultrasonic probe to focus the ultrasonic beam at the plurality of individually spaced focusing regions in the material.

27. The method according to any one of claims 18 to 23, wherein, The materials include organic materials.

28. The method according to any one of claims 18 to 23, wherein, The material includes tissue.

29. The method according to any one of claims 18 to 23, wherein, The material includes skin.

30. The method according to any one of claims 18 to 23, wherein, The elasticity of the material is determined in real time while the ultrasonic beam is being delivered to the material.

31. The method according to any one of claims 18 to 23, further comprising determining the efficacy of ultrasound therapy configured to provide cosmetic or aesthetic improvement in the material, wherein, The material includes biological tissue.

32. The method according to claim 31, wherein, Determining the efficacy of ultrasound treatments configured to provide cosmetic or aesthetic improvements includes relating the determined elasticity to the generation of thermal coagulation points (TCPs) in the biological tissue.

33. A method for measuring the elasticity of a material by generating multiple simultaneous focal points, the method comprising the steps of: Couple the ultrasonic transducer probe to the material surface; The ultrasonic transducer probe includes a single piezoelectric transducer element configured to focus multiple individually spaced focusing regions; The single piezoelectric transducer is used to focus multiple individually separated focusing regions into a region below the surface of the material, wherein focusing at the multiple individually separated focusing regions is simultaneous; The characteristics of multiple shear waves originating from at least two of the plurality of individual focal regions and converging through a query region toward the region between the at least two of the plurality of individual focal regions are obtained; The elasticity of the query region below the skin surface between at least two of the plurality of individual focal zones is determined based on the characteristics of the obtained shear wave; and The effectiveness of non-invasive cosmetic procedures is determined based on the established elasticity. The ultrasound transducer probe includes a single ultrasound transducer configured to apply ultrasound therapy to tissue at multiple individual excitation zones corresponding to the individual focusing zone.

34. The method according to claim 33, wherein, The characteristics of the shear wave include at least one of the shear wave arrival time, the peak displacement of the shear wave, the rise time of the shear wave, and the fall time of the shear wave.

35. The method according to claim 33, wherein, One of the multiple individual excitation regions coincides with a corresponding one of the multiple individual focus regions.

36. The method according to claim 33, wherein, One of the multiple individual excitation regions is spaced apart from the corresponding one of the multiple individual focus regions.

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