Therapeutic system for simultaneously generating multiple focuses at different depths with ultrasound transducers

Abstract

Embodiments of a skin cosmetic treatment and / or imaging system and method adapted to alter the placement and location of a plurality of cosmetic treatment regions in tissue from an ultrasound beam from a transducer, simultaneous multi-focal treatment at a plurality of depths, and / or dithering the ultrasound beam from the transducer to alter the placement and location of the plurality of cosmetic treatment regions in the tissue. The system may include a cane, a removable transducer module, and a control module. In some embodiments, the cosmetic treatment system may be used in a variety of cosmetic procedures. Also disclosed is a treatment system for simultaneously generating multiple focuses at different depths with an ultrasound transducer.

Description

[0001] This application is a divisional application of the PCT international invention patent application with application number 201980006681.3, application date January 22, 2019, and titled “System and method for simultaneous multi-focused ultrasound therapy in multiple dimensions”.

[0002] Incorporated by Reference

[0003] The entire contents of U.S. Provisional Patent Application No. 62 / 622,394, filed on January 26, 2018, are incorporated herein by reference for all purposes. Technical Field

[0004] Several embodiments of the present invention relate to noninvasive energy-based treatments for achieving aesthetic and / or cosmetic enhancement effects on the skin and / or tissue near the skin of the human face, head, neck, and / or body by delivering energy simultaneously or nearly simultaneously to multiple dimensions (e.g., depth, height, width, spacing, orientation, placement) of tissue beneath the skin surface. Background Art

[0005] Some cosmetic procedures involve invasive procedures that may require surgical intervention. Not only do patients have to endure weeks of recovery time, but they are often required to undergo dangerous anesthesia procedures. Non-invasive energy-based treatment devices and methods are available, but may have various drawbacks in terms of efficiency and effectiveness. Summary of the invention

[0006] In several embodiments, systems and methods are provided for successfully achieving aesthetic effects using targeted and precise ultrasound, which produces visible and effective cosmetic effects via a thermal path by splitting an ultrasound treatment beam into two, three, four or more simultaneous focus areas for performing various treatment and / or imaging procedures. In various embodiments, the ultrasound system is configured to focus ultrasound to produce localized mechanical motion within tissues and cells so as to produce local heating for tissue coagulation or mechanical cell membrane disruption 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 tissue that is loose, sagging or sagging, such as submental (under the chin) and neck tissue. In various embodiments, the ultrasound system is configured to improve neck lines 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 for reducing fat and subsequently treating sagging skin caused by fat reduction is provided.

[0007] Although various embodiments are contemplated herein for use in cosmetic treatments, in some embodiments, the systems and programs described herein are also used in non-aesthetic applications.

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

[0009] In various embodiments, treating tissue (e.g., skin tissue) with multiple beams provides one or more advantages, such as, reducing treatment time, creating unique heating patterns, utilizing multiple channels for greater power, the option to treat the skin at two or more depths with the same or different power levels (e.g., a thermal coagulation point in the superficial musculoaponeurotic system ("SMAS") and another defocused energy at the skin surface, or other combinations), optional simultaneous treatment at different depths (e.g., at depths below the skin surface of 1.5 mm, 3 mm, and / or 4.5 mm thermal coagulation points simultaneously or in overlapping time periods); and / or treating with one, two, or more simultaneous linear or line-focused treatments, such as at different depths or spaced apart below the skin surface. In some embodiments, the simultaneous multi-focal treatment uses dithering.

[0010] According to one embodiment, an ultrasound treatment system generates two or more simultaneous treatment treatment points and / or focal areas below the surface of the skin for cosmetic treatment, wherein the treatment point is enlarged by dithering the ultrasound beam. In one embodiment, the focal area is a point. In one embodiment, the focal area is a line. In one embodiment, the focal area is a plane. In one embodiment, the focal area is a three-dimensional volume or shape. Dithering of the focus of the ultrasound beam enlarges the treatment area by changing the frequency of the ultrasound treatment beam and thus changing the focus by mechanically and / or electronically dispersing the position of the focus by air brushing to make the focus or focal area (e.g., focus, line, plane or volume) shake, blur or splatter like paint. In some embodiments, dithering increases efficacy by forming larger treatment points and / or focal areas. In some embodiments, dithering reduces pain because the temperature of the hot spot is distributed over a larger volume of tissue, allowing for potential dose reduction. In some embodiments, mechanical dithering is a method of expanding the acoustic energy from the ultrasound beam, so it is less dependent on thermal conduction of tissue away from the focus. In one embodiment of mechanical dithering, the treatment transducer is locally moved around the expected center of the thermal coagulation point (TCP). The acoustic beam movement can be side-to-side, up-and-down, and / or angled. In one embodiment of mechanical dithering, the movement of the motion mechanism is fast enough to produce a flatter temperature distribution around the intended TCP, which allows for reduced total acoustic energy for the same affected tissue volume or the same total acoustic energy for a larger affected tissue volume, or any combination thereof.

[0011] According to various embodiments, frequency modulation modifies the location of the focal regions and / or the spacing between the focal regions such that electronically dithering the beam via frequency modulation can precisely change and / or move the location of the beam focus. For example, in one embodiment, a 1.5 mm spacing can be dithered by + / - 0.1 mm using a small frequency swing. In various embodiments, any one or more of 0.5, 0.75, 1.0, 1.2, 1.5, 2.0 mm spacing can be dithered by + / - 0.01, 0.05, 0.1, 0.12, 0.15, 0.20, 0.25, 0.30 mm using a frequency swing. In various embodiments, the frequency is modulated 1-200% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 100%, 120%, 150%, 180%, 200% and any ranges therein).

[0012] Several embodiments relate to devices, systems and methods for providing one or more (e.g., multiple or many) focal regions and / or ultrasound treatment points to quickly, safely, efficiently and effectively perform various ultrasound treatment and / or imaging procedures. In some embodiments, imaging is not used. Some embodiments relate to splitting an ultrasound treatment beam from a single ultrasound transducer and / or a single ultrasound transducer element to two, three, four or more focal regions. In some embodiments, multiple ultrasound beams are electronically manipulated with frequency modulation. In some embodiments, dithering (e.g., electronic dithering) of multiple and / or split ultrasound beam apertures using frequency modulation provides treatment regions or points in multiple locations. In some embodiments, dithering involves intentional movement of the position / location of the focus of the energy beam. For example, in one embodiment, dithering involves shaking, moving, vibrating, changing the location and / or position of a single focal region, and / or the relative spacing between two or more focal regions. In various embodiments, the relative position of the focal regions is jittered by 1-50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50% and any range therein, such as a percentage of a certain percentage of the average position). In various embodiments, the spacing between the focal regions is jittered by a range of 1-50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50% and any range therein). In some embodiments, the jittering may be achieved by mechanical, electronic, or a combination of mechanical and electronic means, depending on the system design. In one embodiment of mechanical jittering, the ultrasound beam is locally moved around the center of the intended TCP by mechanical translation or tilting of the treatment transducer or the patient, or any combination thereof. Mechanical translation and / or tilting enables expansion of the acoustic energy such that thermal conduction limitations of the tissue are overcome. This produces a flatter temperature distribution in the tissue to reduce the total acoustic energy to produce the same affected tissue volume or to have the same total acoustic energy to increase the affected tissue volume compared to a fixed ultrasonic treatment device. In various embodiments of electronic dithering, frequency, phase, amplitude modulation or time-based techniques are used in combination with a uniquely defined transducer to move an ultrasound beam in tissue without any mechanical movement. In one embodiment, the electronic movement of the ultrasound beam is significantly faster than mechanical movement to overcome the thermal conductivity limitations of the tissue. In various embodiments, the ratio of relative focal region positioning via dithering is 1:1000, 1:500, 1:200; 1:100, 1:50, 1:25, 1:10, 1:2 or any ratio between 1:1000 and 1:1. In various embodiments, the ratio of the spacing between relative focal region positioning via dithering is 1:1000, 1:500, 1:200; 1:100, 1:50, 1:25, 1:10, 1:2 or any ratio between 1:1000 and 1:1.For example, in some embodiments, the focal zone is activated at "1" and the ratio of the open interval of the untreated tissue is provided in the second digit of the ratio. For example, in one embodiment, the dithering interval is, for example, 1 mm, and the dithering distance is 0.1 mm, so the ratio is 1:10. In various embodiments, the ratio of the intervals between the focal zones via dithering is 1:1000, 1:500, 1:200; 1:100, 1:50, 1:25, 1:10, 1:2 or any ratio between 1:1000 and 1:1. In some embodiments, the dithering simultaneously focuses the intervals of the zones. In some embodiments, treatment points and / or zones are formed simultaneously in the tissue. In various embodiments, the dithering used to perform various treatments and / or imaging procedures is modulated and / or multi-phase, with controlled frequency variation. Some embodiments involve splitting the ultrasound treatment beam into two, three, four or more focal zones for performing various treatments and / or imaging procedures, for example, with dithering, polarization, phasing and / or modulation techniques.

[0013] In several embodiments disclosed herein, the non-invasive ultrasound system is suitable for use in achieving one or more of the following beneficial aesthetic and / or cosmetic improvement effects: face lift, brow lift, chin lift, eye treatment (e.g., zygomatic bags, treatment of infraorbital laxity), wrinkle reduction, fat reduction (e.g., treatment of fat and / or cellulite), treatment of cellulite (which may be referred to as female lipodystrophy) (e.g., concave or non-concave female lipodystrophy), shoulder improvement (e.g., upper chest), buttocks lift (e.g., buttocks tightening), skin tightening (e.g., treatment of laxity to result in facial or body tightening, such as the face, neck, chest, arms, thighs, abdomen, buttocks, etc.), scar reduction (e.g., reduction of breast cystic fibrosis), burn treatment, tattoo removal, vein removal, vein reduction, treatment of sweat glands, treatment of hyperhidrosis, sun spot removal, acne treatment, and pimple reduction. Several embodiments of the present invention are particularly advantageous because they include one, several, or all of the following benefits: faster treatment time, (ii) less pain during treatment, (iii) less pain after treatment, (iv) shorter recovery time, (v) more efficient treatment, (vi) higher customer satisfaction, (vii) less energy required to complete treatment, and / or (viii) larger treatment area provided by the dithered focal area. Various advantages of embodiments of a simultaneous multi-depth treatment device configured to produce multiple TCPs at various depths include producing simultaneous TCPs at multiple depths. In one embodiment, an advantage is elimination of multiple transducers, thereby reducing transducer swapping by the operator. In one embodiment, an advantage is faster treatment time. In one embodiment, an advantage is fewer button presses to deliver the same number of lines. In one embodiment, an advantage is modulation of the distance between TCPs delivered simultaneously. In one embodiment, an advantage is maintaining the pitch separation of TCPs at each depth along the line of mechanical motion. In one embodiment, an advantage is avoiding pulse stacking at multiple depths. In one embodiment, an advantage is the ability to produce larger coagulation and apoptosis areas. In one embodiment, an advantage is the ability to deliver microcoagulation lines along three dimensions. In one embodiment, an advantage of using an electrostrictor includes generating more than two lines with one transducer placed on the patient's body. In one embodiment, an advantage of using an electrostrictor is modulating the distance between TCPs delivered simultaneously. In one embodiment, an advantage is the ability of modulation to attenuate spatial high frequency harmonics from a simultaneous treatment modulation pattern. In one embodiment, an advantage of using an electrostrictor provides the possibility of adding zeros to the modulation pattern. In one embodiment, an advantage of using an electrostrictor is effectively modulating the distance between TCPs delivered simultaneously while electronically steering and focusing the opposing surfaces.This can be in the form of strips, annular rings and segments that are orthogonal (or any angle, such as 0° to 180° (5°, 10°, 15°, 20°, 30°, 45°, 60°, 90° or more) relative to each other) of the electrostrictor strip. In various embodiments, the transducer is segmented. In various embodiments, the flat transducer can be focused with a lens. In various embodiments, the transducer is spherically focused to one or more points. In various embodiments, the transducer is cylindrically focused to one or more lines.

[0014] According to various embodiments, cosmetic ultrasound treatment systems and / or methods can non-invasively generate single or multiple dithering cosmetic treatment areas and / or thermal coagulation points, where ultrasound is focused at one or more locations in the treatment area in tissue beneath the surface of the skin and moved via a change in frequency (e.g., via frequency modulation). Some systems and methods provide cosmetic treatment at different locations in the tissue, such as at different depths, heights, widths, and / or locations. In one embodiment, a method and system include a multi-depth / height / width transducer system configured to provide ultrasound treatment to one or more regions of interest, such as between at least one depth of the treatment area of ​​interest, the surface area of ​​interest, and / or the subcutaneous area of ​​interest. In one embodiment, a method and system include a transducer system configured to provide ultrasound treatment to more than one region of interest, such as between at least two points in various locations in the region of interest in the tissue (e.g., at one or more fixed or variable depths, heights, widths, and / or orientations, etc.). Some embodiments can split the beam to focus at two, three, four, or more focal points (e.g., multiple focal points, multifocal points) for cosmetic treatment areas and / or for imaging in regions of interest in tissue. The position and / or jitter of the focus can be positioned axially, laterally, or otherwise within the tissue. Some embodiments can be configured for spatial control, such as by changing the distance from the transducer to the reflective surface, and / or changing the angle of energy focused or unfocused to the region of interest through the position and / or jitter of the focus, and / or configured for temporal control, such as by controlling changes in the frequency, drive amplitude, and timing of the transducer. In some embodiments, the position and / or jitter of multiple treatment areas or foci is achieved with polarization, phase polarization, bi-phase polarization, and / or multi-phase polarization. In some embodiments, the position of multiple treatment areas or foci is achieved with phasing, such as electrical phasing in one embodiment. As a result, changes in the position of the treatment areas, the number, shape, size, and / or volume of treatment areas or lesions in the region of interest, and thermal conditions can be dynamically controlled over time.

[0015] According to various embodiments, the cosmetic ultrasound treatment system and / or method can use one or more of frequency modulation, phase modulation, polarization, nonlinear acoustics and / or Fourier transforms to generate multiple cosmetic treatment areas to create any spatial periodic pattern with one or more ultrasound sections. In one embodiment, the system uses polarization at the ceramic level to deliver single or multiple treatment areas simultaneously or sequentially. In one embodiment, the polarization pattern depends on the focal depth and frequency, and the use of odd or even functions. In one embodiment, a polarization pattern is applied, which can be a combination of odd or even functions, and is based on the focal depth and / or frequency. In one embodiment, a process can be used in two or more dimensions to create any spatial periodic pattern. In one embodiment, the ultrasound beam is split axially and transversely using nonlinear acoustics and Fourier transforms to significantly reduce treatment time. In one embodiment, modulation from the system and amplitude modulation from the ceramic or transducer can be used to place multiple treatment areas sequentially or simultaneously in the tissue.

[0016] In one embodiment, an aesthetic imaging and treatment system includes an ultrasound probe including an ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations at focal depths by electronic dithering of frequency modulated energy beams through multiple energy beam apertures. In one embodiment, the system includes a control module coupled to the ultrasound probe for controlling the ultrasound transducer.

[0017] In one embodiment, the system includes a dithering configured to provide variable spacing between a plurality of individual cosmetic treatment areas. In one embodiment, the sequence of individual cosmetic treatment areas has a treatment spacing in the range of 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 range thereof), with a dithering change in spacing of 1-50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, and any range thereof). In one embodiment, the sequence of individual cosmetic treatment areas has a treatment interval in the range of about 0.01 mm to about 100 mm (e.g., 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 5 mm, 10 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm and 100 mm, and any range of values ​​therein), with a jitter change in the interval of 1-50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50% and any range thereof).

[0018] In one embodiment, the system further comprises a movement mechanism configured to be programmed to provide a constant or variable spacing between a plurality of individual cosmetic treatment areas. In one embodiment, the sequence of individual cosmetic treatment areas has a treatment spacing in the range of about 0.01 mm to about 50 mm (e.g., 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 19, 20, 25, 30, 35, 40, 45, 49 mm, or any range or value therein). In one embodiment, the sequence of individual cosmetic treatment areas has a treatment spacing in the range of about 0.01 mm to about 100 mm (e.g., 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100 mm, or any range or value therein). In one embodiment, the treatment areas are provided along a distance of about 25 mm. In one embodiment, the treatment areas are provided along a distance of about 50 mm. In various embodiments, the treatment area is provided along a distance of 5 mm to 100 mm (e.g., 10 mm, 20 mm, 25 mm, 35 mm, 50 mm, 75 mm, 100 mm, and any amount or range therein). In various embodiments, the treatment area is provided along a linear and / or curved distance.

[0019] For example, in some non-limiting embodiments, the transducer can be configured for a tissue depth of 0.5 mm, 1.0 mm, 1.5 mm, 2 mm, 3 mm, 4.5 mm, 6 mm, less than 3 mm, between 0.5 mm and 5 mm, between 1.5 mm and 4.5 mm, more than 4.5 mm, more than 6 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, 10 mm, 13 mm, 15 mm, 17 mm). In several embodiments, tissue is treated at a depth below the skin surface, and the skin surface is not damaged. On the contrary, the therapeutic effect achieved at a depth below the skin surface results in a favorable cosmetic appearance of the skin surface. In other embodiments, the skin surface is treated with ultrasound (e.g., at a depth of less than 0.5 mm).

[0020] One benefit of the motion mechanism is that it can provide a more efficient, accurate and precise use of the ultrasonic transducer for imaging and / or therapeutic purposes. One advantage of this type of motion mechanism over a conventional fixed array of multiple transducers fixed in a space in a housing is that the fixed array is separated by a fixed distance. In one embodiment, the transducer module is configured to provide an acoustic power for ultrasonic therapy in the range of about 1W to about 100W or 100W to 1000W (e.g., 3-30W, 7-30W, 21W-33W, 200W, 500W, 750W, 900W) or more and a frequency of about 1MHz to about 20MHz to heat tissue to cause coagulation. In one embodiment, the transducer module is configured to provide an acoustic power for ultrasonic therapy in the range of about 1W to about 500W (e.g., 3-30W, 7-30W, 21-33W, 100W, 220W or more) and a frequency of about 1MHz to about 20MHz to heat tissue to cause coagulation. In some embodiments, instantaneous energy is delivered. In some embodiments, average energy is delivered. In one embodiment, the acoustic power can be in the range of 1W to about 100W in the frequency range of about 1MHz to about 20MHz (e.g., 1MHz, 3MHz, 4MHz, 4.5MHz, 7MHz, 10MHz, 2-12MHz, 15MHz, 18MHz, 2-18MHz), or in the range of about 10W to about 50WMHz in the frequency range of about 3MHz to about 8MHz (e.g., 3MHz, 4MHz, 4.5MHz, 7MHz). In one embodiment, the acoustic power can be in the range of 1W to about 500W in the frequency range of about 1MHz to about 12MHz (e.g., 1MHz, 4MHz, 7MHz, 10MHz, 2-12MHz), or in the range of about 10W to about 220W in the frequency range of about 3MHz to about 8MHz, or 3MHz to 10MHz. In one embodiment, the acoustic power and frequency are about 40W at about 4.3MHz and about 30W at about 7.5MHz. The acoustic energy generated by the acoustic power can be between about 0.01 joules ("J") to about 10J or about 2J to about 5J. The acoustic energy generated by the acoustic power can be between about 0.01J to about 60,000J (e.g., via torso heating for body contouring, submental fat, abdomen and / or flanks, arms, inner thighs, outer thighs, buttocks, loose abdomen, cellulite), about 10J or about 2J to about 5J. In some embodiments, the acoustic energy is in the range of less than about 3J. In various embodiments, the treatment power is 1kW / cm 2 Up to 100kW / cm 2 , 15kW / cm 2 Up to 75kW / cm 2 , 1kW / cm 2 Up to 5kW / cm2 , 500W / cm 2 Up to 10kW / cm 2 , 3kW / cm 2 Up to 10kW / cm 2 , 15kW / cm 2 Up to 50kW / cm 2 , 20kW / cm 2 Up to 40kW / cm 2 , and / or 15kW / cm 2 Up to 35kW / cm 2 .

[0021] In various embodiments, an ultrasound therapy system for dithering multiple simultaneous focal points from an ultrasound transducer includes an ultrasound probe and a control module coupled to the ultrasound probe for controlling the ultrasound transducer. The ultrasound probe includes an ultrasound transducer having a single transducer element, the single transducer element being adapted to simultaneously apply ultrasound therapy to tissue at multiple spaced locations at a focal depth. The ultrasound transducer is polarized with at least a first polarization configuration and a second polarization configuration. The control module modifies the spacing between the spaced locations via dithering of the first and second focal regions, such that the position of the beam focus is precisely moved at the spaced locations via frequency modulated dithering.

[0022] In one embodiment, the plurality of positions are positioned in a cosmetic treatment area in a linear sequence, wherein the spaced positions are separated by a spaced interval via a frequency wobble dither. In one embodiment, a first set of positions are positioned within a first cosmetic treatment area, and a second set of positions are positioned within a second cosmetic treatment area, the first area being different from the second area. In one embodiment, the ultrasonic transducer is adapted to apply the ultrasonic treatment using amplitude modulation, whereby the plurality of portions of the ultrasonic transducer are adapted to transmit the ultrasonic treatment at a plurality of acoustic intensity amplitudes, whereby the first amplitude is different from the second amplitude. In one embodiment, at least a portion of the ultrasonic transducer is adapted to transmit the ultrasonic treatment at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic treatment transmitted by at least a portion of the piezoelectric device varies over time. In one embodiment, the ultrasonic transducer comprises a piezoelectric material, and the plurality of portions of the ultrasonic transducer are adapted to generate a plurality of corresponding piezoelectric material changes in response to an electric field applied to the ultrasonic transducer. In one embodiment, the plurality of piezoelectric material changes comprise at least one of an expansion of the piezoelectric material and a contraction of the piezoelectric material. In one embodiment, the ultrasonic transducer is adapted to apply the ultrasonic treatment via phase shifting, whereby the plurality of portions of the ultrasonic transducer are adapted to transmit the ultrasonic treatment at a plurality of acoustic intensity phases, whereby the first phase is different from the second phase. In one embodiment, the plurality of phases comprises discrete phase values. In one embodiment, the ultrasound transducer is adapted to apply the ultrasound treatment using amplitude modulation, whereby multiple portions of the ultrasound transducer are adapted to transmit the ultrasound treatment at multiple acoustic intensity amplitudes, wherein a first amplitude is different from a second amplitude, and to apply the ultrasound treatment, whereby multiple portions of the ultrasound transducer are adapted to transmit the ultrasound treatment at multiple acoustic intensity phases, wherein a first phase is different from a second phase. Skin tightening is achieved in some embodiments by reducing skin laxity to treat subjects with excess or loose skin after weight loss, whether such weight loss occurred naturally or was achieved surgically.

[0023] In various embodiments, an ultrasound treatment system for dithering multiple simultaneous focal points from an ultrasound transducer in a cosmetic treatment includes an ultrasound probe, the ultrasound probe including a control module adapted to modify the interval between a first focal region and a second focal region via dithering, a switch operable to control an ultrasound treatment function for providing ultrasound treatment, and a moving mechanism adapted to guide the ultrasound treatment in at least one pair of simultaneous sequences of separate thermal cosmetic treatment regions, and a transducer module adapted to apply the ultrasound treatment. The transducer module is adapted to be coupled to the ultrasound probe. The transducer module includes an ultrasound transducer adapted to apply the ultrasound treatment to tissue at multiple locations within the focal depth. The transducer module is adapted to be operably coupled to at least one of the switch and the moving mechanism. The control module includes a processor and a display for controlling the transducer module.

[0024] In one embodiment, the transducer module is adapted to apply ultrasound therapy using amplitude modulation, whereby multiple portions of the transducer module are adapted to transmit ultrasound therapy at multiple acoustic intensity amplitudes, wherein a first amplitude is different from a second amplitude. In one embodiment, the transducer module is adapted to apply ultrasound therapy, whereby multiple portions of the transducer module are adapted to transmit ultrasound therapy at multiple acoustic intensity phases, wherein a first phase is different from a second phase.

[0025] In various embodiments, an ultrasound treatment system for dithered multi-focal therapy includes a module having an ultrasound transducer adapted to simultaneously apply ultrasound treatment to tissue at multiple spaced locations in the tissue, wherein the module modifies the spacing between the multiple spaced locations via dithering of a first focal region and a second focal region so as to precisely move the position of the beam focus at the multiple spaced locations via frequency modulated dithering, wherein the module further includes an interface guide designed to be removably coupled to a cane to provide electronic communication and power between the module and the cane.

[0026] In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy using amplitude modulation, whereby multiple portions of the ultrasonic transducer are adapted to transmit ultrasonic therapy at multiple acoustic intensity amplitudes, wherein the first amplitude is different from the second amplitude. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy, whereby multiple portions of the ultrasonic transducer are adapted to transmit ultrasonic therapy at multiple acoustic intensity phases, wherein the first phase is different from the second phase. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and the multiple portions of the ultrasonic transducer are adapted to produce multiple corresponding piezoelectric material changes in response to an electric field applied to the ultrasonic transducer. In one embodiment, at least a portion of the ultrasonic transducer is adapted to transmit ultrasonic therapy at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic therapy emitted by at least a portion of the ultrasonic transducer remains constant over time. In one embodiment, the ultrasound treatment is a face lift, brow lift, chin lift, eye treatment (e.g., cheekbone bags, treating infraorbital laxity), wrinkle reduction, shoulder enhancement, butt lift, scar reduction, burn treatment, tattoo removal, skin tightening (e.g., tummy tuck treatment or tightening skin in other areas of the body and face, such as any excess skin or tissue, such as during or after weight loss, e.g., the abdomen, buttocks, thighs, arms, and other areas), vein removal, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, vaginal rejuvenation, and acne treatment.

[0027] In various embodiments, a method of dithering simultaneously focused ultrasound therapy beams includes providing an ultrasound probe including an ultrasound transducer including a single transducer element adapted to simultaneously apply ultrasound therapy to tissue at a plurality of spaced locations within a focal depth, and a control module coupled to the ultrasound probe for controlling the ultrasound transducer and dithering the spacing between the spaced locations of a first focal region and a second focal region via a modulation frequency to move the position of the ultrasound focus at the spaced locations.

[0028] In one embodiment, the method includes imaging a first focal region with an ultrasound imaging element. In one embodiment, the method includes imaging a second focal region with an ultrasound imaging element. In one embodiment, the spacing between the first focal region and the second focal region is dithered within a range between 1-50%. In one embodiment, the spacing between the first focal region and the second focal region is 1.5 mm with a fluctuation of 0.1 mm. In one embodiment, the frequency modulation is within a range between 1-50%.

[0029] In various embodiments, a method of dithering a focused ultrasound beam includes providing an ultrasound probe including a single transducer element and a control module, wherein the single transducer element is suitable for applying ultrasound treatment to tissue at a focal region at a focal depth, wherein the control module is coupled to the ultrasound probe for controlling the single transducer element and dithering the focal region via a modulated frequency to change a size of the focal region at the tissue.

[0030] In one embodiment, the relative position of the focal region is jittered in a range between 1-50%. In one embodiment, the second focal region is transmitted simultaneously from a single transducer element. In one embodiment, the method includes imaging the focal region with an ultrasound imaging element. In one embodiment, the frequency modulation is in a range of 1-50%.

[0031] In various embodiments, an ultrasound treatment system for generating multiple focal points and different depths with an ultrasound transducer includes an ultrasound probe, the ultrasound probe including an ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations with at least two focal depths using at least one of the group consisting of amplitude modulation polarization and phase shift, a movement mechanism configured to be programmed to provide spacing between multiple individual cosmetic treatment areas; wherein the sequence of individual cosmetic treatment areas has a treatment spacing in the range of 1 mm to 50 mm, and a control module coupled to the ultrasound probe for controlling the ultrasound transducer, wherein the ultrasound transducer is configured to provide an acoustic power of ultrasound treatment in the range of 10 W to 1000 W and a frequency of 1 MHz to 20 MHz to heat the tissue by heat to cause coagulation. In one embodiment, the multiple locations are positioned in a substantially linear sequence within the cosmetic treatment area, and the ultrasound transducer includes a single ultrasound transducer element. In one embodiment, a first set of locations are positioned within a first cosmetic treatment area, and a second set of locations are positioned within a second cosmetic treatment area, the first area being different from the second area. In one embodiment, the first cosmetic treatment area comprises a substantially linear sequence of a first set of locations, and the second cosmetic treatment area comprises a substantially linear sequence of a second set of locations. In one embodiment, the ultrasound transducer is configured to apply the ultrasound treatment using amplitude modulation, whereby portions of the ultrasound transducer are configured to transmit the ultrasound treatment at a plurality of acoustic intensity amplitudes, wherein a first amplitude is different from a second amplitude.

[0032] In one embodiment, the ultrasonic transducer is configured to apply an ultrasonic treatment phase shift, whereby multiple portions of the ultrasonic transducer are configured to transmit ultrasonic treatment at multiple acoustic intensity phases, wherein the first phase is different from the second phase. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic treatment using amplitude modulation, whereby multiple portions of the ultrasonic transducer are configured to transmit ultrasonic treatment at multiple acoustic intensity amplitudes, where the first amplitude is different from the second amplitude; and apply an ultrasonic treatment phase shift, whereby multiple portions of the ultrasonic transducer are configured to transmit ultrasonic treatment at multiple acoustic intensity phases, where the first phase is different from the second phase. In one embodiment, the multiple phases include discrete phase values. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and the multiple portions of the ultrasonic transducer are configured to generate multiple corresponding piezoelectric material changes in response to an electric field applied to the ultrasonic transducer. In one embodiment, the multiple piezoelectric material changes include at least one of an expansion of the piezoelectric material and a contraction of the piezoelectric material. In one embodiment, at least a portion of the ultrasonic transducer is configured to transmit ultrasonic treatment at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic treatment emitted by at least a portion of the piezoelectric varies over time. In one embodiment, the moving mechanism is configured to be programmed to provide variable spacing between multiple separate cosmetic treatment areas, and also includes one or more selectable tuning circuits. In one embodiment, the sequence of separate cosmetic treatment areas has a treatment interval in the range of 1 mm to 25 mm, further comprising a tuned circuit. In one embodiment, the ultrasound treatment is at least one of a face lift, brow lift, chin lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, skin tightening, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, cellulite treatment, shoulder treatment, vaginal rejuvenation, and acne treatment. In one embodiment, the ultrasound transducer is configured to provide an acoustic power for ultrasound treatment in the range of between 10 W to 100 W and a frequency of 1 MHz to 12 MHz to heat tissue by heat to induce coagulation.

[0033] In various embodiments, a treatment system for simultaneously generating multiple focal points at different depths with an ultrasound transducer, the system comprising an ultrasound probe having a first switch operably controlling an ultrasound imaging function for providing ultrasound imaging, a second switch operably controlling an ultrasound treatment function for providing ultrasound treatment, and a moving mechanism configured to direct the ultrasound treatment in at least one sequence of separate thermal cosmetic treatment areas, and a transducer module configured to apply the ultrasound treatment with at least one of the group consisting of amplitude modulation polarization and phase shift, wherein the transducer module is configured for ultrasound imaging and ultrasound treatment, wherein the transducer module is configured for coupling to the ultrasound probe, wherein the transducer module comprises an ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations having at least two focal depths, wherein the transducer module is configured to be operably coupled to at least one of the first switch, the second switch and the moving mechanism; and a control module, wherein the control module comprises a processor and a display for controlling the transducer module.

[0034] In one embodiment, the ultrasound treatment is a cosmetic treatment, wherein the plurality of positions are positioned in a substantially linear sequence within a cosmetic treatment area. In one embodiment, the ultrasound treatment is a cosmetic treatment, wherein a first set of positions are positioned within a first treatment area, and a second set of positions are positioned within a second treatment area, the first area being different from the second area. In one embodiment, the first treatment area comprises a substantially linear sequence of the first set of positions, and the second treatment area comprises a substantially linear sequence of the second set of positions. In one embodiment, the transducer module is configured to apply the ultrasound treatment using amplitude modulation, whereby the plurality of portions of the transducer module are configured to transmit the ultrasound treatment at a plurality of acoustic intensity amplitudes, where the first amplitude is different from the second amplitude. In one embodiment, the transducer module is configured to apply an ultrasound treatment phase shift, whereby the plurality of portions of the transducer module are configured to transmit the ultrasound treatment at a plurality of acoustic intensity phases, where the first phase is different from the second phase. In one embodiment, the transducer module is configured to apply the ultrasound treatment using amplitude modulation, whereby the plurality of portions of the transducer module are configured to transmit the ultrasound treatment at a plurality of acoustic intensity amplitudes, where the first amplitude is different from the second amplitude; and to apply an ultrasound treatment phase shift, whereby the plurality of portions of the transducer module are configured to transmit the ultrasound treatment at a plurality of acoustic intensity phases, where the first phase is different from the second phase. In one embodiment, the plurality of phases comprises discrete phase values. In one embodiment, the transducer module includes a piezoelectric material, and the plurality of portions of the transducer module are configured to generate a plurality of corresponding piezoelectric material changes in response to an electric field applied to the transducer module. In one embodiment, the plurality of piezoelectric material changes include at least one of expansion of the material and contraction of the material. In one embodiment, at least a portion of the transducer module is configured to emit an ultrasonic treatment at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic treatment emitted by at least a portion of the transducer module varies over time. In one embodiment, the movement mechanism is configured to be programmed to provide a variable spacing between a plurality of separate thermal cosmetic treatment areas. In one embodiment, the sequence of separate cosmetic treatment areas has a treatment spacing in the range of 1 mm to 25 mm. In one embodiment, the first and second switches include user-operated buttons or keys. In one embodiment, at least one of the first switch and the second switch is activated by the control module. In one embodiment, the ultrasonic treatment is at least one of a face lift, a brow lift, a chin lift, an eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, cellulite treatment, shoulder treatment, vaginal rejuvenation, and acne treatment. In one embodiment, the transducer module is configured to provide therapeutic ultrasound acoustic power in a range between 10 W to 1000 W and a frequency of 1 MHz to 20 MHz to thermally heat tissue to induce coagulation.

[0035] In various embodiments, a treatment system for delivering simultaneous treatment at multiple depths, the system includes a control device operable to control an ultrasound treatment function for providing ultrasound treatment; and a cane configured to direct the ultrasound treatment in a sequence of separate thermal cosmetic treatment zones, the cane including a transducer configured to apply the ultrasound treatment to tissue at a location at a focal depth, the location being positioned within the thermal cosmetic treatment zone, wherein the transducer is further configured to simultaneously apply the ultrasound treatment to tissue at multiple locations at the focal depth.

[0036] In various embodiments, a method for performing a non-invasive cosmetic procedure on the skin by producing multiple simultaneous focal points at multiple depths with a single transducer, the method comprising coupling a transducer module to an ultrasound probe; wherein the ultrasound probe includes a first switch that controls acoustic imaging; wherein the ultrasound probe includes a second switch that controls acoustic therapy for causing multiple separate cosmetic treatment areas; wherein the ultrasound probe includes a movement mechanism that provides desired spacing between the separate cosmetic treatment areas; bringing the transducer module into contact with the skin surface of a subject; activating the first switch on the ultrasound probe to acoustically image an area below the skin surface with the transducer module; and activating the second switch on the ultrasound probe to acoustically treat an area below the skin surface with the transducer module in a desired sequence of separate cosmetic treatment areas controlled by the movement mechanism, wherein the transducer module includes a single ultrasound transducer configured to apply ultrasonic therapy to tissue at multiple focal depths.

[0037] In various embodiments, an ultrasound treatment system for simultaneously generating multiple focal points at multiple depths in tissue using an ultrasound transducer, the system comprising a control device operable to control an ultrasound treatment function for providing ultrasound treatment; and a cane configured to direct the ultrasound treatment in a sequence of separate thermal cosmetic treatment areas, the cane comprising: a transducer configured to apply ultrasound treatment to tissue at multiple locations at the focal depth.

[0038] In various embodiments, an imaging and treatment system for cosmetic treatment at multiple depths in tissue, the system includes an ultrasound probe configured for ultrasound imaging and ultrasound treatment of tissue at multiple focal depths, including a transducer module configured to be coupled to the ultrasound probe, wherein the transducer module includes an ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations at the focal depths, a first switch operably controlling an ultrasound imaging function for providing ultrasound imaging; a second switch operably controlling an ultrasound treatment function for providing ultrasound treatment; and a movement mechanism configured to direct the ultrasound treatment in at least one sequence of separate thermal cosmetic treatment areas; and wherein the transducer module is configured to be operably coupled to at least one of the first switch, the second switch and the movement mechanism; and a control module, wherein the control module includes a processor and a display for controlling the transducer module.

[0039] In one embodiment, the plurality of positions are positioned in a substantially linear sequence within the cosmetic treatment area. In one embodiment, a first set of positions are positioned within the first cosmetic treatment area and a second set of positions are positioned within the second cosmetic treatment area, the first area being different from the second area. In one embodiment, the first cosmetic treatment area comprises a substantially linear sequence of the first set of positions and the second cosmetic treatment area comprises a substantially linear sequence of the second set of positions. In one embodiment, the transducer module is configured to apply ultrasound therapy using amplitude modulation, whereby the plurality of portions of the transducer module are configured to transmit ultrasound therapy at a plurality of acoustic intensity amplitudes, wherein the first amplitude is different from the second amplitude. In one embodiment, the transducer module is configured to apply ultrasound therapy phase shifts, whereby the plurality of portions of the transducer module are configured to transmit ultrasound therapy at a plurality of acoustic intensity phases, wherein the first phase is different from the second phase. In one embodiment, the transducer module is configured to apply ultrasound therapy using amplitude modulation, whereby the plurality of portions of the transducer module are configured to transmit ultrasound therapy at a plurality of acoustic intensity amplitudes, wherein the first amplitude is different from the second amplitude; and apply ultrasound therapy phase shifts, whereby the plurality of portions of the transducer module are configured to transmit ultrasound therapy at a plurality of acoustic intensity phases, wherein the first phase is different from the second phase. In one embodiment, the plurality of phases comprises discrete phase values. In one embodiment, the transducer module includes a piezoelectric material, and the plurality of portions of the transducer module are configured to generate a plurality of corresponding piezoelectric material changes in response to an electric field applied to the transducer module. In one embodiment, the plurality of piezoelectric material changes include at least one of expansion of the material and contraction of the material. In one embodiment, at least a portion of the transducer module is configured to emit ultrasound treatment at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasound treatment emitted by at least a portion of the transducer module varies over time. In one embodiment, the movement mechanism is configured to be programmed to provide a variable interval between a plurality of separate thermal cosmetic treatment areas. In one embodiment, the sequence of separate thermal cosmetic treatment areas has a treatment interval in the range of 0.01 mm to 25 mm. In one embodiment, the first and second switches include user-operated buttons or keys. In one embodiment, at least one of the first switch and the second switch is activated by the control module. In one embodiment, the treatment function is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, vaginal rejuvenation, and acne treatment. In one embodiment, the transducer module is configured to provide therapeutic ultrasound acoustic power in a range between 10 W to 1000 W and a frequency of 1 MHz to 10 MHz to thermally heat tissue to induce coagulation.

[0040] In various embodiments, a multi-focus ultrasound treatment system for simultaneous treatment at multiple depths, the system includes a control device operable to control an ultrasound treatment function for providing ultrasound treatment; a cane configured to direct the ultrasound treatment in a sequence of separate thermal cosmetic treatment zones, the cane including a transducer configured to apply ultrasound treatment to tissue at a location within the focal depth, the location being positioned within the thermal cosmetic treatment zone, wherein the transducer is further configured to simultaneously apply ultrasound treatment to tissue at multiple locations within the focal depth.

[0041] In various embodiments, an imaging and simultaneous multi-focal therapy system at multiple depths includes a module having an ultrasound transducer, wherein the ultrasound transducer is configured to apply ultrasound therapy to tissue at multiple focal depths with at least one of the group consisting of amplitude modulated polarization and phase shift, wherein the module further includes an interface guide designed to be removably coupled to a cane to provide electronic communication and power between the module and the cane.

[0042] In one embodiment, the plurality of positions are positioned in a substantially linear sequence within the cosmetic treatment area. In one embodiment, a first set of positions are positioned within the first cosmetic treatment area and a second set of positions are positioned within the second cosmetic treatment area, the first area being different from the second area. In one embodiment, the first cosmetic treatment area comprises a substantially linear sequence of the first set of positions and the second cosmetic treatment area comprises a substantially linear sequence of the second set of positions. In one embodiment, the ultrasonic transducer is configured to apply the ultrasonic treatment using amplitude modulation, whereby the plurality of portions of the ultrasonic transducer are configured to transmit the ultrasonic treatment at a plurality of acoustic intensity amplitudes, wherein the first amplitude is different from the second amplitude. In one embodiment, the ultrasonic transducer is configured to apply an ultrasonic treatment phase shift, whereby the plurality of portions of the ultrasonic transducer are configured to transmit the ultrasonic treatment at a plurality of acoustic intensity phases, wherein the first phase is different from the second phase. In one embodiment, the ultrasonic transducer is configured to apply the ultrasonic treatment using amplitude modulation, whereby the plurality of portions of the ultrasonic transducer are configured to transmit the ultrasonic treatment at a plurality of acoustic intensity amplitudes, wherein the first amplitude is different from the second amplitude; and to apply an ultrasonic treatment phase shift, whereby the plurality of portions of the ultrasonic transducer are configured to transmit the ultrasonic treatment at a plurality of acoustic intensity phases, wherein the first phase is different from the second phase. In one embodiment, the plurality of phases comprises discrete phase values. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and the plurality of portions of the ultrasonic transducer are configured to generate a plurality of corresponding piezoelectric material changes in response to an electric field applied to the ultrasonic transducer. In one embodiment, the plurality of piezoelectric material changes include at least one of an expansion of the piezoelectric material and a contraction of the piezoelectric material. In one embodiment, at least a portion of the ultrasonic transducer is configured to emit an ultrasonic treatment at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic treatment emitted by at least a portion of the piezoelectric varies over time. In one embodiment, the imaging and treatment system includes a movement mechanism configured to be programmed to provide spacing between a plurality of separate cosmetic treatment areas. In one embodiment, the sequence of separate cosmetic treatment areas has a treatment spacing in the range of 1 mm to 50 mm. In one embodiment, the ultrasonic treatment is at least one of a face lift, a brow lift, a chin lift, an eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, vaginal rejuvenation, and acne treatment. In one embodiment, the ultrasound transducer is configured to provide therapeutic ultrasound acoustic power in the range of 1 W to 100 W and a frequency of 1 MHz to 10 MHz to thermally heat tissue to induce coagulation.

[0043] In various embodiments, a treatment system for simultaneous treatment at multiple depths, the system comprising: a control device operable to control an ultrasound treatment function for providing ultrasound treatment; and a cane configured to direct the ultrasound treatment in a sequence of separate thermal cosmetic treatment areas, the cane comprising a transducer configured to simultaneously apply ultrasound treatment to tissue at multiple locations at the focal depth.

[0044] In various embodiments, a non-invasive method for performing cosmetic procedures simultaneously at multiple depths that is not performed by a physician includes coupling a transducer module to an ultrasound probe; wherein the transducer module includes an ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations at a focal depth with at least one of the group consisting of amplitude modulated polarization and phase shift, wherein the ultrasound probe includes a first switch that controls acoustic imaging; wherein the ultrasound probe includes a second switch that controls the acoustic treatment for causing multiple separate cosmetic treatment areas; wherein the ultrasound probe includes a movement mechanism that provides a desired spacing between the separate cosmetic treatment areas; bringing the transducer module into contact with a skin surface of a subject; activating the first switch on the ultrasound probe to acoustically image an area below the skin surface with the transducer module; and activating the second switch on the ultrasound probe to acoustically treat the area below the skin surface with the transducer module in a desired sequence of separate cosmetic treatment areas controlled by the movement mechanism.

[0045] In various embodiments, an ultrasound therapy system for dithering multiple simultaneous focal points from an ultrasound transducer at multiple depths includes an ultrasound probe, the ultrasound probe including an ultrasound transducer having a single transducer element, the single transducer element being adapted to simultaneously apply ultrasound therapy to tissue at multiple spaced focal depths, wherein the ultrasound transducer is polarized with at least a first polarization configuration and a second polarization configuration, a control module coupled to the ultrasound probe for controlling the ultrasound transducer, wherein the control module modifies the spacing between spaced locations via dithering of the first and second focal regions such that the position of the beam focus is precisely moved at the spaced locations via frequency modulated dithering.

[0046] In one embodiment, a plurality of positions are positioned in a cosmetic treatment area in a linear sequence, wherein the spaced positions are separated by a spaced interval via a frequency wobble dither. In one embodiment, a first set of positions are positioned within a first cosmetic treatment area, and a second set of positions are positioned within a second cosmetic treatment area, the first area being different from the second area. In one embodiment, the ultrasonic transducer is adapted to apply the ultrasonic treatment using amplitude modulation, whereby a plurality of portions of the ultrasonic transducer are adapted to transmit the ultrasonic treatment at a plurality of acoustic intensity amplitudes, whereby the first amplitude is different from the second amplitude. In one embodiment, at least a portion of the ultrasonic transducer is adapted to transmit the ultrasonic treatment at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic treatment transmitted by at least a portion of the piezoelectric device varies over time. In one embodiment, the ultrasonic transducer comprises a piezoelectric material, and the plurality of portions of the ultrasonic transducer are adapted to generate a plurality of corresponding piezoelectric material changes in response to an electric field applied to the ultrasonic transducer. In one embodiment, the plurality of piezoelectric material changes comprise at least one of an expansion of the piezoelectric material and a contraction of the piezoelectric material. In one embodiment, the ultrasonic transducer is adapted to apply the ultrasonic treatment via phase shifting, whereby a plurality of portions of the ultrasonic transducer are adapted to transmit the ultrasonic treatment at a plurality of acoustic intensity phases, whereby the first phase is different from the second phase. In one embodiment, the plurality of phases comprises discrete phase values. In one embodiment, the ultrasound transducer is adapted to apply ultrasound treatment using amplitude modulation, whereby multiple portions of the ultrasound transducer are adapted to transmit ultrasound treatment at multiple acoustic intensity amplitudes, wherein a first amplitude is different from a second amplitude; and apply ultrasound treatment, whereby multiple portions of the ultrasound transducer are adapted to transmit ultrasound treatment at multiple acoustic intensity phases, wherein a first phase is different from a second phase. In one embodiment, the ultrasound treatment is at least one of: face lift, brow lift, chin lift, eye treatment, wrinkle reduction, shoulder improvement, buttocks lift, scar reduction, burn treatment, skin tightening, blood vessel reduction, treating sweat glands, sun spot removal, fat treatment, abdominal relaxation treatment, and cellulite treatment. In one embodiment, the ultrasound probe includes a movement mechanism, wherein the movement mechanism is adapted to guide the ultrasound treatment in at least one pair of simultaneous sequences of separate thermal cosmetic treatment areas. In one embodiment, the ultrasound probe is configured for ultrasound imaging and ultrasound treatment. In one embodiment, the ultrasound probe includes a transducer module adapted to apply ultrasound treatment.

[0047] In various embodiments, an ultrasound treatment system for dithering a plurality of simultaneous focal points at a plurality of depths from an ultrasound transducer in a cosmetic treatment, the system comprising an ultrasound probe having a control module adapted to modify a separation between a first focal region and a second focal region via dithering, operable to control a switch of an ultrasound treatment function for providing ultrasound treatment; and a moving mechanism adapted to direct the ultrasound treatment in at least one pair of simultaneous sequences of separate thermal cosmetic treatment regions; and a transducer module adapted to apply the ultrasound treatment, wherein the transducer module is adapted to be coupled to the ultrasound probe, wherein the transducer module comprises an ultrasound transducer adapted to apply the ultrasound treatment to tissue at a plurality of locations having at least two focal depths, wherein the transducer module is adapted to be operably coupled to at least one of the switch and the moving mechanism; and wherein the control module comprises a processor and a display for controlling the transducer module.

[0048] In one embodiment, the transducer module is adapted to apply ultrasound therapy using amplitude modulation, whereby multiple portions of the transducer module are adapted to transmit ultrasound therapy at multiple acoustic intensity amplitudes, wherein a first amplitude is different from a second amplitude. In one embodiment, the transducer module is adapted to apply ultrasound therapy, whereby multiple portions of the transducer module are adapted to transmit ultrasound therapy at multiple acoustic intensity phases, wherein a first phase is different from a second phase.

[0049] In various embodiments, an ultrasound therapy system for dithered simultaneous multi-focal therapy at multiple depths includes a module having an ultrasound transducer, wherein the ultrasound transducer is adapted to simultaneously apply ultrasound therapy to tissue at multiple interval depths in the tissue, wherein the module modifies intervals between the multiple interval depths via dithering of a first focal region and a second focal region such that the position of the beam focus is precisely moved at the multiple interval depths via frequency modulated dithering, wherein the module further includes an interface guide designed to be removably coupled to a cane to provide electronic communication and power between the module and the cane.

[0050] In one embodiment, the ultrasonic transducer is adapted to apply the ultrasonic treatment using amplitude modulation, whereby multiple portions of the ultrasonic transducer are adapted to transmit the ultrasonic treatment at multiple acoustic intensity amplitudes, wherein the first amplitude is different from the second amplitude. In one embodiment, the ultrasonic transducer is adapted to apply the ultrasonic treatment, whereby multiple portions of the ultrasonic transducer are adapted to transmit the ultrasonic treatment at multiple acoustic intensity phases, wherein the first phase is different from the second phase. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and the multiple portions of the ultrasonic transducer are adapted to produce multiple corresponding piezoelectric material changes in response to an electric field applied to the ultrasonic transducer. In one embodiment, at least a portion of the ultrasonic transducer is adapted to transmit the ultrasonic treatment at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic treatment emitted by at least a portion of the ultrasonic transducer remains constant over time. In one embodiment, the ultrasonic treatment is at least one of a face lift, a brow lift, a chin lift, an eye treatment, wrinkle reduction, shoulder enhancement, butt lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, cellulite treatment, abdominal relaxation treatment, vaginal rejuvenation, and acne treatment.

[0051] In various embodiments, a method of dithering a simultaneously focused ultrasound therapy beam at multiple depths includes providing an ultrasound probe including an ultrasound transducer including a single transducer element adapted to simultaneously apply ultrasound therapy to tissue at a plurality of spaced locations at a plurality of focal depths, and a control module coupled to the ultrasound probe for controlling the ultrasound transducer and dithering the spacing between the spaced locations of a first focal region and a second focal region via frequency modulation to move the position of the ultrasound focus at the spaced locations.

[0052] In one embodiment, the method further comprises imaging the first focal area with an ultrasound imaging element. In one embodiment, the method further comprises imaging the second focal area with an ultrasound imaging element. In one embodiment, the spacing between the first focal area and the second focal area is jittered within a range between 1-50%. In one embodiment, the spacing between the first focal area and the second focal area is 1.5 mm with a fluctuation of 0.1 mm. In one embodiment, the frequency modulation is within a range between 1-50%. In one embodiment, the ultrasound treatment is at least one of a face lift, a brow lift, a chin lift, an eye treatment, wrinkle reduction, shoulder enhancement, buttocks lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, vaginal rejuvenation, abdominal relaxation treatment, and acne treatment.

[0053] In various embodiments, a method of simultaneously dithering a focused ultrasound beam at multiple depths includes providing an ultrasound probe including a single transducer element and a control module, wherein the single transducer element is adapted to apply ultrasound therapy to tissue at a focal region at a focal depth, wherein the control module is coupled to the ultrasound probe for controlling the single transducer element, and dithering the focal region via frequency modulation to vary a size of the focal region at the tissue.

[0054] In one embodiment, the relative position of the focal region is jittered within a range between 1-50%. In one embodiment, the second focal region is simultaneously transmitted from a single transducer element. In one embodiment, the frequency modulation is within a range between 1-50%. In one embodiment, the system is designed to operate non-invasively to treat tissue. In one embodiment, the method operates in a non-invasive manner to treat tissue.

[0055] In various embodiments, an ultrasound therapy system for delivering simultaneous multi-focal therapy at multiple depths with an electrostrictor includes a module having an ultrasound transducer, wherein the ultrasound transducer is adapted to simultaneously apply ultrasound therapy to tissue at multiple interval depths in the tissue through application of the electrostrictor, wherein the module modifies the intervals between the multiple interval depths via dithering of a first focal region and a second focal region such that the position of the beam focus is precisely moved at the multiple interval depths via frequency modulated dithering, wherein the module further includes an interface guide designed to removably couple to a cane to provide electronic communication and power between the module and the cane.

[0056] In one embodiment, the ultrasonic transducer is adapted to apply the ultrasonic treatment using amplitude modulation, whereby multiple portions of the ultrasonic transducer are adapted to transmit the ultrasonic treatment at multiple acoustic intensity amplitudes, wherein the first amplitude is different from the second amplitude. In one embodiment, the ultrasonic transducer is adapted to apply the ultrasonic treatment, whereby multiple portions of the ultrasonic transducer are adapted to transmit the ultrasonic treatment at multiple acoustic intensity phases, wherein the first phase is different from the second phase. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and the multiple portions of the ultrasonic transducer are adapted to produce multiple corresponding piezoelectric material changes in response to an electric field applied to the ultrasonic transducer. In one embodiment, at least a portion of the ultrasonic transducer is adapted to transmit the ultrasonic treatment at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic treatment emitted by at least a portion of the ultrasonic transducer remains constant over time. In one embodiment, the ultrasonic treatment is at least one of a face lift, a brow lift, a chin lift, an eye treatment, wrinkle reduction, shoulder enhancement, butt lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, cellulite treatment, abdominal relaxation treatment, vaginal rejuvenation, and acne treatment.

[0057] In various embodiments, an ultrasound therapy system is provided, having one or more features described in the specification. In various embodiments, a method of reducing imaging misalignment in a mobile ultrasound transducer is provided, having one or more features described in the specification. In various embodiments, an ultrasound therapy system for generating multiple simultaneous focal points from an ultrasound transducer is provided, having one or more features described in the specification. In various embodiments, an ultrasound therapy system for delivering multi-focal therapy is provided, having one or more features described in the specification. In various embodiments, an ultrasound therapy module for forming multiple simultaneous focal areas from an ultrasound transducer in cosmetic treatments is provided, having one or more features described in the specification. In various embodiments, a method of generating simultaneously focused ultrasound therapy beams using multi-channel signal mixing is provided, having one or more features described in the specification. In various embodiments, a method of generating simultaneously focused ultrasound beams is provided, having one or more features described in the specification.

[0058] In several embodiments described herein, the procedures are purely cosmetic rather than medical. For example, in one embodiment, the methods described herein need not be performed by a doctor, but rather performed at a spa or other beauty institution. In some embodiments, the system can be used for non-invasive cosmetic treatments of the skin.

[0059] The methods summarized above and further elaborated below describe certain actions taken by a practitioner; however, it should be understood that they may also include instructions to these actions by another party. Thus, an action such as "dithering the energy beam" includes "instructing dithering of the energy beam".

[0060] In some embodiments, the system includes various features that are present as a single feature (as opposed to multiple features). For example, in one embodiment, the system includes a single transducer element that produces two simultaneous therapeutic foci of dithering. Multiple features or components are provided in alternative embodiments. In various embodiments, the system comprises, consists essentially of, 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 disclaimed from a particular claim such that the system does not have such a feature or component.

[0061] Furthermore, areas of applicability will become apparent from the description provided herein.It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the embodiments disclosed herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way. Embodiments of the present invention will be more fully understood from the detailed description and drawings, in which:

[0063] Figure 1A is a schematic diagram of an ultrasound system according to various embodiments of the present invention.

[0064] Figure 1B is a schematic diagram of an ultrasound system according to various embodiments of the present invention.

[0065] Figure 1C is a schematic diagram of an ultrasound system according to various embodiments of the present invention.

[0066] Figure 2 is a schematic diagram of an ultrasound system coupled to a region of interest according to various embodiments of the present invention.

[0067] Figure 3 is a schematic diagram of a portion of a transducer according to various embodiments of the present invention.

[0068] Figure 4 is a partial cross-sectional side view of an ultrasound system according to various embodiments of the present invention.

[0069] Figure 5 is a table showing focus separation for apertures with different spatial frequencies according to various embodiments of the present invention.

[0070] Figure 6 is a graph illustrating focus separation for apertures with different aperture spatial frequencies according to various embodiments of the present invention.

[0071] Figure 7 is a graph illustrating focus separation for apertures with different aperture spatial frequencies according to various embodiments of the present invention.

[0072] Figure 8 is a schematic diagram of aperture polarization with spatial frequency that can be modified by the excitation channel according to various embodiments of the present invention.

[0073] Fig. 9 is a schematic diagram of a poled ceramic having a spatial frequency that can be modified by exciting a channel covering two polarized regions of the ceramic according to various embodiments of the present invention.

[0074] Fig.10 is a schematic diagram of an embodiment of an array transducer having an imaging transducer.

[0075] Fig.11 are schematic diagrams of a transducer viewed from a convex side, a side cross-section, and a concave side according to various embodiments of the present invention.

[0076] Fig.12 are schematic diagrams of a transducer viewed from a convex side, a side cross-section, and a concave side according to various embodiments of the present invention.

[0077] Fig.13 are schematic diagrams of a transducer viewed from a convex side, a side cross-section, and a concave side according to various embodiments of the present invention.

[0078] Fig.14 are schematic diagrams of a transducer viewed from a convex side, a side cross-section, and a concave side according to various embodiments of the present invention.

[0079] Fig.15 are schematic diagrams of a transducer viewed from a convex side, a side cross-section, and a concave side according to various embodiments of the present invention.

[0080] Fig.16 are schematic diagrams of a transducer viewed from a convex side, a side cross-section, and a concave side according to various embodiments of the present invention.

[0081] Fig.17 are schematic diagrams of a transducer viewed from the convex side and the concave side according to various embodiments of the present invention.

[0082] Fig.18 is a schematic diagram of multiple thermal coagulation zones at various depths produced by a transducer according to various embodiments of the present invention.

[0083] Fig.19 is based on Fig.18 Schematic diagram of the xz plane of multiple thermal coagulation zones at various depths produced by the transducer.

[0084] Fig. 20 is based on Fig.18 Schematic diagram of the yz plane of multiple thermal coagulation zones at various depths produced by the transducer.

[0085] Fig.21 is a schematic diagram of multiple thermal coagulation zones at various depths produced by a transducer according to various embodiments of the present invention.

[0086] Fig. 22 is based on Fig.21 Schematic diagram of the xz plane of multiple thermal coagulation zones at various depths produced by the transducer.

[0087] Fig.23 is based on Fig.21 Schematic diagram of the yz plane of multiple thermal coagulation zones at various depths produced by the transducer.

[0088] Fig.24 is a schematic diagram of multiple thermal coagulation zones at various depths produced by a transducer according to various embodiments of the present invention.

[0089] Fig.25 is based on Fig.24Schematic diagram of the xz plane of multiple thermal coagulation zones at various depths produced by the transducer.

[0090] Fig.26 is based on Fig.24 Schematic diagram of the yz plane of multiple thermal coagulation zones at various depths produced by the transducer.

[0091] Fig. 27 is a schematic diagram of multiple thermal coagulation zones at various depths produced by a transducer according to various embodiments of the present invention.

[0092] Fig.28 is based on Fig. 27 Schematic diagram of the xz plane of multiple thermal coagulation zones at various depths produced by the transducer.

[0093] Fig.29 is based on Fig. 27 Schematic diagram of the yz plane of multiple thermal coagulation zones at various depths produced by the transducer.

[0094] Fig.30 are schematic diagrams of a transducer viewed from the convex side and the concave side according to various embodiments of the present invention.

[0095] Fig.31 is a schematic diagram of multiple thermal coagulation zones at various depths produced by a transducer according to various embodiments of the present invention.

[0096] Fig.32 is based on Fig.31 Schematic diagram of the xz plane of multiple thermal coagulation zones at various depths produced by the transducer.

[0097] Fig.33 is based on Fig.31 Schematic diagram of the yz plane of multiple thermal coagulation zones at various depths produced by the transducer.

[0098] Fig.34 is a schematic diagram of multiple thermal coagulation zones at various depths produced by a transducer according to various embodiments of the present invention.

[0099] Fig.35 is based on Fig.34 Schematic diagram of the xz plane of multiple thermal coagulation zones at various depths produced by the transducer.

[0100] Fig.36 is based on Fig.34 Schematic diagram of the yz plane of multiple thermal coagulation zones at various depths produced by the transducer.

[0101] Fig.37is a graph showing amplitude and DC corresponding to focal plane focus produced by a transducer according to various embodiments of the present invention. DETAILED DESCRIPTION

[0102] The following description sets forth examples of embodiments and is not intended to limit the present invention or its teachings, applications or uses. It should be understood that throughout the accompanying drawings, corresponding reference numerals represent identical or corresponding parts and features. The description of the specific embodiments indicated in the various embodiments of the present invention is for illustrative purposes only and is not intended to limit the scope of the present invention disclosed herein. Moreover, the description of multiple embodiments with the features is not intended to exclude other embodiments with additional features or other embodiments comprising different combinations of the features. In addition, the features in one embodiment (e.g., in one figure) may be combined with the descriptions (and figures) of other embodiments.

[0103] In various embodiments, systems and methods for ultrasonic treatment of tissue are adapted and / or configured to provide cosmetic treatment. In some embodiments, devices and methods are provided in several embodiments that direct ultrasonic treatment to a single focus or multiple simultaneous focuses, using ultrasonic imaging to confirm adequate acoustic coupling to the treatment area to improve performance or provide improved correlation between movement in the first and second directions when forming images in cosmetic and / or medical procedures. In various embodiments as used herein, "simultaneous" means occurring at the same time, or the time difference is less than 1ms, 0.5ms, 0.1ms, 0.05ms or 0.01ms. In various embodiments, tissues below or even at the surface of the skin, such as the epidermis, dermis, fascia, muscle, fat, and the superficial musculoaponeurotic system ("SMAS"), are treated non-invasively with ultrasonic energy. Ultrasonic energy can be focused on one or more treatment points and / or areas, can be unfocused and / or defocused, and can be applied to an area of ​​interest comprising at least one of the epidermis, dermis, subcutaneous, fascia, muscle, fat, cellulite, and SMAS to achieve cosmetic and / or therapeutic effects. In various embodiments, the systems and / or methods provide non-invasive skin treatment to tissue by 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 lift, brow lift, chin lift, eye treatment (e.g., zygomatic 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), buttocks lift (e.g., buttocks tightening), skin laxity treatment (e.g., treating tissue for tightening or abdominal laxity treatment), scar reduction, burn treatment, tattoo removal, vein removal, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, acne treatment and pimple removal. In one embodiment, fat reduction is achieved. In various embodiments, one or more characteristics of cellulite (e.g., dimpling or non-dimpling female lipodystrophy) (e.g., compared to, for example, untreated tissue) (e.g., dimpling, nodules, "orange peel" appearance, etc.) are 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 can be achieved simultaneously.

[0104] Various embodiments of the present invention relate to a device or method 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, cryogenics, electron beam, photon-based, magnetic, magnetic resonance and / or other energy forms. Various embodiments of the present invention relate to a device or method for splitting an ultrasound energy beam into multiple beams. In various embodiments, the device or method can be used to change 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, with therapeutic ultrasound, tissue effects are achieved by concentrating 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 can 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 TCP at specific locations, thermal and / or mechanical ablation of tissue can occur non-invasively or remotely. In some embodiments, the ultrasound treatment does not include cavitation and / or shock waves. In some embodiments, the ultrasound treatment includes cavitation and / or shock waves.

[0105] In one embodiment, TCP can be generated in a linear or substantially linear, curved or substantially curved region or sequence, wherein each individual TCP is separated from an adjacent TCP by a treatment interval. In one embodiment, multiple TCP sequences can be generated in a treatment region. For example, TCP 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 applied by generating individual TCPs in one and multiple sequences of individual TCPs, it may be desirable to reduce the treatment time and the corresponding risk of pain and / or discomfort experienced by the patient. Treatment time can be reduced by forming multiple TCPs simultaneously, nearly 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.

[0106] Various embodiments of the present invention address the potential challenges of administering ultrasound therapy. In various embodiments, the time for TCP formation for achieving the desired cosmetic and / or therapeutic treatment of the desired clinical method 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, tear ducts, 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 relaxation), stomach, liver, kidneys, uterus, breast, vagina, prostate, testicles, glands, thyroid, viscera, hair, muscle, bone, ligament, cartilage, fat, fat lobes, adipose tissue, subcutaneous tissue, implanted tissue, implanted organ, lymph, tumor, cyst, abscess or part of a nerve, or any combination thereof.

[0107] Various embodiments of simultaneous ultrasound treatment at multiple locations in tissue are described in U.S. Application No. 14 / 193,234, published on September 11, 2014 as U.S. Publication No. 2014 / 0257145, which is incorporated herein by reference in its entirety.

[0108] System Overview

[0109] refer to Figure 1A , 1B1C, various embodiments of the ultrasound system 20 include a stick (e.g., a handpiece) 100, a module (e.g., a transducer module, a box, a probe) 200, and a controller (e.g., a console) 300. In some embodiments, the console 300 includes a communication system (e.g., wifi, Bluetooth, a modem, etc.) to communicate with another party, a manufacturer, a supplier, a service provider, the Internet, and / or the cloud. In some embodiments, a cart 301 provides mobility and / or location of the system 20, and may include wheels, a surface on which to write or place components, and / or compartments 302 (e.g., drawers, containers, shelves, etc.) to, for example, store or organize components. In some embodiments, the cart has a power source, such as a power connection to a battery and / or one or more wires that connect power, communications (e.g., Ethernet) to the system 20. In some embodiments, the system 20 includes the cart 301. In some embodiments, the system 20 does not include the cart 301. The stick 100 can be coupled to the controller 300 via an interface 130, which can be a wired or wireless interface. The interface 130 can be coupled to the cane 100 via a connector 145. The distal end of the interface 130 can be connected to a controller connector on a circuit 345 (not shown). In one embodiment, the interface 130 can transmit controllable power from the controller 300 to the cane 100. In one embodiment, the system 20 has multiple imaging channels (e.g., 8 channels) for ultra-clear HD (high definition) visualization of subcutaneous structures to improve imaging. In one embodiment, the system 20 includes multiple treatment channels (e.g., 8 channels) and precision linear drive motors that double the treatment accuracy while increasing speed (e.g., 25%, 40%, 50%, 60%, 75%, 100% or more). Together, these features establish one of the most versatile system platforms in the industry and lay the foundation for unprecedented future possibilities.

[0110] In various embodiments, the controller 300 may be adapted and / or configured to operate with the wand 100 and the module 200 and the functionality of the overall ultrasound system 20 . In various embodiments, a plurality of controllers 300, 300', 300", etc. may be adapted and / or configured to operate with a plurality of canes 100, 100', 100", etc. and / or a plurality of modules 200, 200', 200", etc. The controller 300 may include connectivity to one or more interactive graphical displays 310, which may include a touch screen monitor and a graphical user interface (GUI) that allows a user to interact with the ultrasound system 20. In one embodiment, a second smaller, more mobile display screen allows a user to more easily locate and view the treatment screen. In one embodiment, the second display allows a 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, the graphical display 310 includes a touch screen interface 315 (not shown). In various embodiments, the display 310 sets and displays operating conditions, including device activation status, treatment parameters, system messages and prompts, and ultrasound images. In various embodiments, the controller 300 may be adapted and / or configured to include, for example, a microprocessor with software and input / output devices for controlling the electronics and The controller 300 may include a system processor and various analog and / or digital control logic, such as one or more of a microcontroller, a microprocessor, a field programmable gate array, a computer board and related components, including firmware and control software, which may be capable of interfacing with user controls and interface circuits as well as input / output circuits and systems for communication, display, interface, storage, file compilation and other useful functions. The system software running on the system process 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 appropriately adapted and / or configured to control the operation of the ultrasound system 20.

[0111] In one embodiment, the cane 100 includes one or more finger-activated controls or switches, such as 150 and 160. In various embodiments, one or more thermal treatment controls 160 (e.g., switches, buttons) start and / or stop treatment. In various embodiments, one or more imaging controls 150 (e.g., switches, buttons) start and / or stop 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, an interface guide 235 or multiple interface guides 235 may be used to help couple the module 200 to the cane 100. The module 200 may include one or more ultrasonic transducers 280. In some embodiments, the ultrasonic transducer 280 includes one or more ultrasonic elements. The module 200 may include one or more ultrasonic 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 in one or more directions 290 within the module 200. The transducer 280 is connected to a motion mechanism 400. In various embodiments, the motion mechanism includes zero, one or more bearings, shafts, rods, screws, lead screws 401, encoders 402 (e.g., optical encoders that measure the position of the transducer 280), motors 403 (e.g., stepper motors) to help ensure accurate and repeatable movement of the transducer 280 within the module 200. In various embodiments, the module 200 may include a transducer 280 that may transmit energy through the acoustically transparent member 230. In one embodiment, the control module 300 may be coupled to the cane 100 via the interface 130, and the graphical user interface 310 may be adapted and / or configured for use with the control module 200. In one embodiment, the control module 300 may provide power to the cane 100. In one embodiment, the cane 100 may include a power source. In one embodiment, switch 150 may be adapted and / or configured to control a tissue imaging function, and switch 160 may be adapted and / or configured to control a tissue treatment function. In various embodiments, module 200 provides, through controlled operation of control system 300 of transducer 280, delivery of transmitted energy 50 at an appropriate focal depth, distribution, timing, and energy level to achieve a desired treatment effect with a thermal coagulation zone 550 ("TCP," e.g., thermal coagulation point).

[0112] In one embodiment, the module 200 can be coupled to the cane 100. The module 200 can transmit and receive energy, such as ultrasonic energy. The module 200 can be electronically coupled to the cane 100, and such coupling can include an interface for communicating with the controller 300. In one embodiment, the interface guide 235 can be adapted and / or configured to provide electronic communication between the module 200 and the cane 100. The module 200 can include various probe and / or transducer configurations. For example, the module 200 can be adapted and / or configured for a combined dual-mode imaging / therapy transducer, a coupled or co-housed imaging / therapy transducer, a separate therapy and imaging probe, etc. In one embodiment, when the module 200 is inserted into or connected to the cane 100, the controller 300 automatically detects it and updates the interactive graphical display 310.

[0113] In some embodiments, an access key 320 (e.g., a secure USB drive, key) is connected (e.g., removably) to the system 20 to allow the system 20 to work. In various embodiments, the access key is programmed to be customer-specific and serves a variety of functions, including system security, country-specific access to treatment guidelines and functions, software upgrades, support log transfers and / or credit transfers and / or storage. In various embodiments, the system 20 has Internet and / or data connectivity. In embodiments, connectivity provides a method by which data is transferred between the system 20 provider and the customer. In various embodiments, the data includes credit, software updates, and support logs. Connectivity is divided 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 have Internet access. Credit transfers and software upgrades are performed by sending an access key (e.g., USB drive) to the customer. In one embodiment, semi-connected model connectivity includes a console disconnected from the Internet, but the customer is able to have Internet access. Credit transfers, software upgrades, and support log transfers are performed using the customer's personal computer, smart phone, or other computing device in conjunction with the system access key to transfer data. In one embodiment, fully connected model connectivity includes a console that connects wirelessly to the internet using wifi, cellular modem, bluetooth or other protocols. Credit transfers, software upgrades and support log transfers occur directly between the console and the cloud. In various embodiments, the system 20 connects to an online portal for streamlined inventory management, on-demand processing of purchases and business analytics insights to drive client beauty treatment businesses to the next level.

[0114] In various embodiments, tissue below or even at the surface of the skin, such as the epidermis, dermis, hypodermis, fascia, and superficial musculoaponeurotic system ("SMAS") and / or muscle, is non-invasively treated with ultrasound energy. The tissue may also include blood vessels and / or nerves. The ultrasound energy may be focused, unfocused, or defocused and applied to an area of ​​interest comprising at least one of the epidermis, dermis, hypodermis, fascia, and SMAS to achieve a therapeutic effect. Figure 2 is a schematic diagram of an ultrasound system 20 coupled to a region of interest 10. In various embodiments, the tissue layers of the region of interest 10 can be located on any part of the subject's body. In one embodiment, the tissue layers are located in the head and facial region of the subject. A cross-sectional portion of the tissue of the region of interest 10 includes a skin surface 501, an epidermis layer 502, a dermis 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 a hypodermis 504, which may include any tissue below the dermis layer 503. The combination of these layers may be collectively referred to as subcutaneous tissue 510. In Figure 2 Also shown in the figure is a treatment area 525 located below the surface 501. In one embodiment, the surface 501 can be the skin surface of the subject 500. Although embodiments involving treatment at a tissue layer 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 for tissue (including but not limited to muscle, fascia, SMAS, dermis, epidermis, fat, adipocytes, one or a combination of cellulite, which may be referred to as female lipodystrophy (e.g., non-depressed female lipodystrophy), collagen, skin, blood vessels) on the face, neck, head, arms, legs, or any other location on or in the body (including body cavities). In various embodiments, the amount of cellulite (e.g., non-depressed female lipodystrophy) reduction reaches 2%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 75%, 80%, 90%, 95% and any range therein.

[0115] refer to Figure 2 , an embodiment of the ultrasound system 20 includes a wand 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 a transducer 280 adapted and / or configured to treat tissue at multiple focal depths 278. In one embodiment, the focal depth 278 is the distance between the transducer 280 and the target tissue for treatment. In one embodiment, the focal depth 278 is fixed for a given transducer 280. In one embodiment, the focal depth 278 is variable for a given transducer 280. In one embodiment, the transducer 280 is configured to simultaneously treat at multiple depths below the skin surface (e.g., 1.5 mm, 3.0 mm, 4.5 mm, or other depths).

[0116] refer to Figure 4 , the module 200 may include a transducer 280 that can transmit energy through the acoustically transparent member 230. In various embodiments, the depth may refer to the depth of focus 278. In one embodiment, the transducer 280 may have an offset distance 270, which is the distance between the transducer 280 and the surface of the acoustically transparent member 230. In one embodiment, the depth of focus 278 of the transducer 280 is a fixed distance from the transducer. In one embodiment, the transducer 280 may have a fixed offset distance 270 from the transducer to the acoustically transparent member 230. In one embodiment, the acoustically transparent member 230 is adapted and / or configured to be located at a location on the module 200 or the ultrasound system 20 to contact the skin surface 501. In various embodiments, the amount by which the depth of focus 278 exceeds the offset distance 270 corresponds to treatment at a target area located at a tissue depth 279 below the skin surface 501. In various embodiments, when the ultrasound system 20 is placed in physical contact with the skin surface 501, the tissue depth 279 is the distance between the acoustically transparent member 230 and the target area, measured as the distance from the portion of the surface of the wand 100 or module 200 that contacts the skin (with or without an acoustic coupling gel, medium, etc.) and the depth in the tissue of the target area from that skin surface contact point. 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 that contacts the coupling medium and / or the skin 501) plus the tissue depth 279 below the skin surface 501 to the target area. In various embodiments, the acoustically transparent member 230 is not used.

[0117] The coupling component may include various substances, materials and / or devices to facilitate the coupling of the transducer 280 or module 200 to the region of interest. For example, the coupling component may include an acoustic coupling system that is suitable and / or configured for acoustic coupling of ultrasonic energy and signals. An acoustic coupling system with possible connections (e.g., a manifold) can be used to couple sound into the region of interest, providing liquid or fluid-filled lens focusing. The coupling system can facilitate such coupling by using one or more coupling media, the coupling medium including air, gas, water, liquid, fluid, gel, solid, non-gel and / or any combination thereof, or any other medium that allows signals to be transmitted between the transducer 280 and the region of interest. In one embodiment, one or more coupling media are provided inside the transducer. In one embodiment, the fluid-filled module 200 contains one or more coupling media inside the housing. In one embodiment, the fluid-filled module 200 contains one or more coupling media inside a sealed housing that is 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 tissue 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.

[0118] In various embodiments, the transducer 280 can image and treat the region of interest at any suitable tissue depth 279. In one embodiment, the transducer module 280 can provide acoustic power in a 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, the 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., 3 MHz, 4 MHz, 4.5 MHz, 7 MHz, 10 MHz), and greater than about 10 MHz. In one embodiment, the 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, the 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, the module 200 has a focal depth 278 for treating at a tissue depth 279 of about 1.5 mm below the skin surface 501. Some non-limiting embodiments of the transducer 280 or module 200 may be adapted and / or configured for delivering ultrasound energy at a tissue depth of 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, etc., and any point in the range of 0-3 mm, 0-4.5 mm, 0-6 mm, 0-25 mm, 0-100 mm, etc., and any depth therein. In one embodiment, the ultrasound system 20 is provided with two or more transducer modules 280. For example, a first transducer module may apply treatment at a first tissue depth (e.g., about 4.5 mm), a second transducer module may apply treatment at a second tissue depth (e.g., about 3 mm), and a third transducer module may apply treatment at a third tissue depth (e.g., about 1.5-2 mm). In one embodiment, at least some or all of the transducer modules may be adapted and / or configured to apply therapy at substantially the same depth.

[0119] In various embodiments, varying the number of focal positions (e.g., such as with tissue depths 279) used for an ultrasound procedure may be advantageous because it allows a patient to be treated 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 results of a single treatment session. For example, treatment at multiple depths beneath a single surface area allows for a greater total volume of tissue treatment, which results in enhanced collagen formation and tightening. In addition, treatment at different depths affects different types of tissue, thereby producing different clinical effects that together provide an enhanced overall cosmetic effect. For example, surface treatments can reduce the visibility of wrinkles, and deeper treatments can induce the formation of more collagen growth. Similarly, treatment at various locations at the same or different depths can improve treatment.

[0120] Although it may be advantageous in some embodiments to treat a subject at different locations in one treatment course, it may be beneficial to treat in a temporal sequence in other embodiments. For example, a subject may be treated at 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 may be on the order of nanoseconds, microseconds, milliseconds, seconds, minutes, hours, days, weeks, months, or other time periods. The new collagen produced by the first treatment may be more sensitive to subsequent treatments, which may be desirable for some indications. Alternatively, it may be advantageous to perform multi-depth treatments at the same surface area in a single treatment course because treatment at one depth may synergistically enhance or supplement 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 may be adjusted or controlled for varying depths. Safety features that minimize the risk of selecting the wrong depth may be used in conjunction with a single module system.

[0121] In several embodiments, a method of treating the lower face and neck area (e.g., the submental area) is provided. In several embodiments, a method of treating (e.g., softening) chin-lip folds is provided. In other embodiments, methods of treating the eye area (e.g., zygomatic bags, treating infraorbital laxity) are provided. By treating at variable depths, several embodiments will achieve improved upper eyelid laxity and improved periorbital lines and texture. By treating at different locations in a single session, the optimal clinical effect (e.g., softening, tightening) can be achieved. 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 facelifts or liposuction, where skin tightening is desired. In various embodiments, the methods can be applied to any part of the body.

[0122] In one embodiment, the transducer module 200 allows a treatment sequence at a fixed depth at or below the skin surface. In one embodiment, the transducer module allows a treatment sequence at one, two or more variable or fixed depths below the dermis. In several embodiments, the transducer module includes a moving mechanism that is suitable for and / or configured to guide ultrasound treatment in a sequence of separate thermal injuries (hereinafter referred to as "thermal coagulation points" or "TCPs") at a fixed focal depth. In one embodiment, the sequence of separate TCPs has a treatment interval within a range of 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 range thereof), and the dithering of the interval is changed to 1-50% (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, the individual TCPs are discrete. In one embodiment, the individual TCPs are overlapping. In one embodiment, the moving mechanism is adapted and / or configured to be programmed to provide a variable interval between the individual TCPs. In one embodiment, the jitter may be adapted and / or configured to provide a variable interval between the individual TCPs. In several embodiments, the transducer module includes a moving mechanism adapted and / or configured to guide the ultrasound treatment in a sequence so that the TCPs are formed in a linear or substantially linear sequence separated by a treatment distance. 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 from the first linear sequence by a treatment distance. 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 to about 3 mm, etc. In several embodiments, the transducer module may include one or more movement mechanisms 400 adapted and / or configured to direct ultrasound therapy in a sequence such that TCPs are formed in a linear or substantially linear sequence of individual thermal lesions separated from other linear sequences by a treatment distance. In one embodiment, therapy is applied in a first direction 290 (e.g., push). In one embodiment, therapy is applied opposite to the first direction 290 (e.g., pull). In one embodiment, therapy is applied in the first direction 290 and in a direction opposite to the first direction (e.g., push and pull). In one embodiment, the treatment distances separating the linear or substantially linear TCP sequences are the same or substantially the same.In one embodiment, the treatment distance separating the linear or substantially linear TCP sequences is different or substantially different for various adjacent pairs of linear TCP sequences.

[0123] 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 can be attached to a handle or cane of the 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, and the second transducer module is adapted and / or configured to apply ultrasound therapy to a second tissue layer. The second layer of tissue is at a different depth than the first layer of tissue.

[0124] like Figure 3 As shown in, in various embodiments, the module 200 provides, through controlled operation of the control system 300, delivery of emitted energy 50 with appropriate focal depth 278, distribution, timing and energy level to achieve the desired therapeutic effect of controlled thermal injury 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 of a depth corresponding to the depth for treating muscle is shown. In various embodiments, the depth can correspond to any tissue, tissue layer, skin, epidermis, dermis, hypodermis, fat, SMAS, muscle, blood vessels, nerves, or other tissue. During operation, the module 200 and / or transducer 280 can also mechanically and / or electronically scan along the surface 501 to treat an extended area. Before, during, and after delivering ultrasound energy 50 to at least one of the epidermis layer 502, dermis layer 503, hypodermis 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 the controller 300 and the user via the graphical interface 310.

[0125] In one embodiment, the ultrasound system 20 generates ultrasound energy that is directed and focused below the surface 501. The controlled and focused ultrasound energy 50 creates thermal coagulation points or zones (TCPs) 550. In one embodiment, the ultrasound energy 50 creates voids in the subcutaneous tissue 510. In various embodiments, the transmitted energy 50 targets tissue below the surface 501, which cuts, ablates, coagulates, micro-ablates, manipulates and / or causes TCPs 550 in the tissue portion 10 below the surface 501 at a specified focal depth 278. In one embodiment, during a treatment sequence, the transducer 280 moves in the direction indicated by the arrows labeled 290 at specified intervals 295 to create a series of treatment areas 254, each of which receives transmitted energy 50 to create one or more TCPs 550. In one embodiment, the arrows labeled 291 show axes or directions that are orthogonal or parallel to the arrows 290, and the spacing of the TCPs 550 shows that the TCPs can be spaced orthogonal or parallel to the direction of motion of the transducer 280. In some embodiments, the orientation of the spaced TCPs can be set at any angle from 0-180 degrees to arrow 290. In some embodiments, the orientation of the spaced TCPs can be set at any angle from 0-180 degrees based on the orientation of the polarization regions on transducer 280.

[0126] In various embodiments, the transducer module may include one or more transducer elements. The transducer elements may include piezoelectrically active materials such as lead zirconate titanate (PZT), or any other piezoelectrically active materials 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, in addition to or in lieu of the piezoelectrically active materials, the transducer module may include any other material suitable and / or configured for generating radiation and / or acoustic energy. In various embodiments, the transducer module may be suitable and / or configured to operate at different frequencies and treatment depths. The 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 an OD of 19 mm and an F L =15mm. In other embodiments, other suitable OD and F may be used. L value, such as OD less than about 19 mm, greater than about 19 mm, etc., F LLess than about 15mm, greater than about 15mm, etc. The transducer module can be adapted and / or configured to apply ultrasonic energy at different target tissue depths. As described above, in several embodiments, the transducer module includes a moving mechanism that is adapted and / or configured to guide ultrasonic treatment in a linear or substantially linear sequence of separate TCPs, with treatment intervals between separate TCPs. For example, the treatment interval can be about 1.1mm, 1.5mm, etc. In several embodiments, the transducer module can also include a moving mechanism that is adapted and / or configured to guide ultrasonic treatment in a sequence so 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 separated from the first linear sequence by a treatment interval of about 2mm to 3mm. In one embodiment, a user can manually move the transducer module on the surface of the treatment area so that adjacent TCP linear sequences are generated. In one embodiment, the moving mechanism can automatically move the transducer module on the surface of the treatment area so that adjacent TCP linear sequences are generated.

[0127] Aperture Space Frequency Analysis and Fourier Transform

[0128] In various embodiments, spatial frequency analysis techniques based on Fourier analysis and Fourier optics can be used to improve the efficiency of therapeutic treatment. When a system with an impulse response h(t) is excited by a stimulus x(t), the relationship between the input x(t) and the output y(t) is related by the following convolution function:

[0129]

[0130] In various embodiments, a Fourier transform may be applied to calculate the convolution of equation (1). A continuous one-dimensional Fourier transform may be defined as:

[0131]

[0132] 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:

[0133] F(x(t)*h(t))=X(f)H(f)=Y(f) (3)

[0134] 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 described in Joseph Goodman, Introduction to Fourier Optics (3rd ed., 2004), which is incorporated herein by reference in its entirety. According to the Fraunhofer approximation, the far-field composite amplitude pattern produced by the 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 light propagation and sound propagation. In the case of optics and / or ultrasound, the two-dimensional Fourier transform can determine the acoustic wave pressure amplitude distribution at the focus of the transducer.

[0135] For a focusing system, the variable z representing depth can be replaced by the variable z representing focal length. f replace.

[0136]

[0137]

[0138] In various embodiments, Fourier optics and Fourier transform identities (some of which are listed in Table 1 below) can be used for ultrasound transducers to determine the intensity distribution corresponding to the transducer design. For example, the Fourier transform of a rectangle rect(ax) is a sinc function. As another example, the Fourier transform of a two-dimensional circle of uniform amplitude is a first-order Bessel function, which can be represented as J1.

[0139]

[0140]

[0141] Table 1

[0142] In several embodiments, the ultrasound transducer may have a rectangular aperture of suitable size and focal length. In several embodiments, the ultrasound transducer may have a circular aperture of suitable size 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 a circular transducer may be described as:

[0143]

[0144]

[0145] For example, in one embodiment, variable "a" may be approximately 9.5 mm and variable "b" in equation (5a) may be approximately 2 mm. Applying a Fourier transform to equation (5a) may provide an estimate of the acoustic wave pressure distribution at the focus.

[0146]

[0147] where ξ x and y 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 ultrasound 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).

[0148] 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 focus. In one embodiment, the cosine function can be applied to a circular aperture as follows:

[0149]

[0150] The energy distribution or beam response at the focus of the modulated aperture in equation (7) is the sum of the two

[0151] Convolution of the Fourier transforms of functions:

[0152]

[0153] 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):

[0154]

[0155] Equation (9) shows that the two beams appearing at the focus are spatially offset compared to the original unmodulated beams. In several embodiments, one or more other modulation functions (e.g., a sine function) may be used to achieve a desired beam response. In several embodiments, the aperture may be modulated so that more than two focal points are generated. For example, three, four, five, etc. focal points may be generated. In several embodiments, the aperture may be modulated so that the focal points are generated sequentially or approximately sequentially rather than simultaneously.

[0156] In several embodiments, the treatment transducer module includes a moving mechanism configured to guide ultrasound treatment in a linear or substantially linear sequence of separate TCPs with treatment intervals between the separate TCPs. For example, the treatment intervals may be approximately 1.1 mm, 1.5 mm, etc. In several embodiments, the transducer module may also include a moving mechanism configured to guide ultrasound treatment in a sequence so 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 separated from the first linear sequence by a treatment interval of approximately 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 beam may be achieved at the focus (or before the focus). In one embodiment, two simultaneous or nearly simultaneous focused beams separated by a treatment interval of approximately 1.1 mm may be generated in a linear or substantially linear sequence. At an ultrasound frequency of 7 MHz, the wavelength of ultrasound in water is approximately 0.220 mm. Therefore, the spatial frequency ξ at the focus x and y It is expressed as:

[0157]

[0158]

[0159] To separate the two foci by about 1.1 mm, the spatial frequency used to modulate the aperture is then calculated as follows. Using identities 3 and 4 in Table 2, the Fourier transform of a sine or cosine function is a Dirac delta function with parameters:

[0160]

[0161] In one embodiment, when the parameter is 0, equation (11a) can be solved for k x :

[0162]

[0163] In addition, x o One half of the separation distance (e.g., 1.1 mm) can be used instead:

[0164]

[0165] In several embodiments, a transducer having a circular aperture that transmits ultrasonic energy at various operating frequencies may be modulated by sine and / or cosine functions of the spatial frequencies listed in Table 2. The modulated aperture of the transducer may produce simultaneous or substantially simultaneous split beams with two focal points having 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.

[0166]

[0167] Table 2

[0168] As shown in Table 2, in several embodiments, for a given focus separation distance, the spatial frequency of the aperture modulation function increases as the ultrasound operating frequency increases. Additionally, the spatial frequency increases as the desired focus separation distance increases.

[0169] In one embodiment, higher spatial frequencies can cause amplitude transitions in the aperture to occur more quickly. Due to transducer processing limitations, rapid amplitude changes in the aperture can reduce aperture efficiency because there may be differences in the amount of acoustic pressure generated by different parts of the aperture. In one embodiment, using spatial frequencies to split the beams simultaneously or nearly simultaneously can reduce the total focal gain of each beam. As shown in equation (9), the field pressure drop at the focus of each beam is reduced by a factor of two compared to the unmodulated beam. In one embodiment, the acoustic pressure or ultrasound intensity from the aperture can be increased to obtain similar or substantially similar intensities 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, the increase in pressure at the aperture can increase the total intensity in the near field, which can increase the possibility of overheating tissue in the treatment area located in front of the focus. In one embodiment, the possibility of additional heating of tissue in front of the focus can be limited or eliminated by using a lower ultrasound treatment frequency.

[0170] In one embodiment, applying an aperture modulation function as shown in equation (7) results in two simultaneous or substantially simultaneous ultrasound beams at the focus. In various embodiments, the ultrasound beam may be split multiple times, such as three times, four times, five times, etc., so that multiple simultaneous or substantially simultaneous beams are generated. In one embodiment, four equally spaced beams along one dimension may be generated by modulating or multiplying the aperture by two independent spatial frequencies:

[0171]

[0172]

[0173] As shown in equation (12b), an unmodulated beam at the focus 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 focus position:

[0174]

[0175]

[0176] In one embodiment, 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 due to system, material and / or tissue limitations. In one embodiment, due to the possibility of heating tissue in the treatment area located in front of the focal point, the frequency of the ultrasound treatment may be adjusted (e.g., reduced) to limit and / or eliminate this possibility. In one embodiment, nonlinear techniques may be applied at the focal point to limit and / or eliminate the possibility of heating tissue in front of the focal point. In one embodiment, the acoustic pressure or ultrasound intensity from the aperture may be increased to obtain a similar or substantially similar intensity at the focal plane.

[0177] In various embodiments, if the amplitude and phase functions at the aperture are separable, the two-dimensional Fourier transform of the sound pressure function U(x1, y1) can be expressed as the product of the one-dimensional Fourier transforms of the two functions of x and y. In various embodiments, it may be advantageous to generate multiple TCPs in a linear or substantially linear sequence and to generate multiple linear sequences simultaneously or nearly simultaneously.

[0178] Multibeam splitting aperture using frequency modulated electronic dithering

[0179] In various embodiments, Table 2 shows the spatial frequency of the aperture 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 the focal points is also a function of the operating frequency. For example, in one embodiment, the spatial frequency of the aperture (k x ) is fixed at 1.0 mm -1 , and the operating frequency is allowed to vary. Equation 11c can be rewritten to show how the focus separation distance can be modulated by the operating frequency.

[0180] s = (k x z f v c ) / (π f op ) (14)

[0181] where k x is the spatial frequency in mm -1 , z fis the focal depth of the aperture in mm, v c is the ultrasonic velocity in the propagation medium (e.g. water) in mm / μsec, and f op is the operating frequency of the aperture in MHz. In one embodiment, the following substitution is made in Equation 11c:

[0182] λ = v c / f op (15)

[0183] As shown in equation (14), the separation distance of the focal points is a function of the operating frequency. In addition, the rate of change of the separation distance with respect to the operating frequency is:

[0184] ds / df op =-(k x z f v c ) / (π f op 2 ) (16)

[0185] 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 operating frequency for different spatial frequencies (eg, 4 MHz, 7 MHz, 10 MHz in various embodiments).

[0186]

[0187]

[0188] Table 3

[0189] As shown in Table 3, as the operating frequency increases, the focus becomes closer, and as the operating frequency decreases, the focus becomes farther away, without changing the phase or mechanically moving the transducer. This is a unique method of electronically moving the beam to spread the energy without relying on thermal conduction in the tissue. Benefits include a reduction or minimization of the maximum temperature and an increase in the thermal coagulation volume of the lesion without the need for additional system channels.

[0190] The amount of movement from the main operating frequency can be determined by using equation (14). In one embodiment, the main 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 5 Table 4 shows the different spatial frequencies (kx = 0.5, 1.0, 1.5, 2.0, in mm) designed for a center frequency of 5 MHz. -1) of the aperture. It also calculates the amount of expansion of the focus from a 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.

[0191] Figure 6 The difference in spacing of all operating frequencies of the aperture for different aperture spatial frequencies is shown. Figure 6 As shown, the separation distance increases as the frequency decreases.

[0192] In one embodiment, the separation distance is relative to a frequency of 5 MHz. In one embodiment, one way to estimate electronic jitter from frequency modulation can be determined by referencing all movements to an initial separation at 5 MHz. Figure 7 As shown, the spread of the separation distance between foci can easily vary by more than 1 mm.

[0193] In various embodiments, the range of possible operating frequencies from an aperture can be described in terms of 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 center frequency by locating the frequency at which the transmit intensity decreases to -3dB of the peak transmit intensity. In one embodiment, for the transmit response of the transducer aperture, the -3dB high frequency is designated as f -3db，H and the -3dB low frequency is specified as f -3dB,L The -3dB center frequency in [MHz] is described as:

[0194] f -3dB，center =(f -3dB，H +f -3dB，L ) / 2 (17)

[0195] The -3dB percentage bandwidth is described as:

[0196] BW -3dB =100%*(f -3dB，H -f -3dB，L ) / ((f -3dB，H +f -3dB，L ) / 2) (18)

[0197] In some embodiments, increasing the range of possible operating frequencies within an aperture may be accomplished by using, but not limited to, backing layers, matching layers, multiple piezoelectric layers, electrical matching, piezoelectric composites, and / or single crystal piezoelectric ceramics. In one embodiment, as the bandwidth of the transducer increases, the range of possible separation distances increases. Table 5 (below) shows how the focal spread may change based on the percentage bandwidth if the aperture center frequency is 5 MHz. For a 0.5 mm -1 , 1.00mm-1 , 1.50mm -1 , 2.00mm -1 The spatial frequency at the aperture is 1.50mm, and the focal separation distances at 5MHz are 0.72mm, 1.43mm, 2.15mm, and 2.86mm respectively. -1 And the transducer bandwidth is 60%, then the separation distance between the foci varies by 1.42 mm, which is a distance greater than the lateral resolution of the beam at 5 MHz.

[0198] Additional extension from 5 MHz center frequency, in [mm]

[0199]

[0200] Table 5

[0201] In one embodiment, as the frequency changes, the depth of field as well as the lateral resolution and focal gain will also change. In one embodiment, as the frequency changes, the depth of field, lateral resolution, and focal gain will also change. Thus, in one embodiment, the intensity at the aperture can be changed according to the heating rate target. Also, in some embodiments, it may be advantageous to send multiple operating frequencies simultaneously to spread the energy immediately or nearly immediately. For example, the transmit excitation of the aperture can include excitation at 4 MHz, 5 MHz, and 6 MHz, all at the same time.

[0202] Multiple focal points achieved by varying the aperture spatial frequency

[0203] As shown in Equation 14, the higher the aperture spatial frequency, the greater the separation distance between the foci. In one embodiment, the aperture is spaced at a spatial frequency k x Polarization. By connecting separate electrical excitation channels with the ability to modify the phase to 0 or 180 degrees, the spatial frequency can be easily doubled or reduced to zero, as Figure 8 For example, if the phase on channels 1 to 16 is 0 degrees, the aperture spatial frequency is k x In an embodiment, when the phase on each channel varies from 0 degrees to 180 degrees so that odd channels are at 0 degrees and even channels are at 180 degrees, then the spatial frequency at the aperture is 1 / 2k x In an embodiment, if the phase is repeated every two channels so 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 2k 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 , the corresponding separation distances are 0 mm, 0.72 mm, 1.43 mm, and 2.86 mm, which produce seven unique focal positions separated by 0.36 mm. In various embodiments, intermediate phases between 0 and 180 degrees will further allow the two focal points to be tilted so that a focal line can be generated at the focal plane. Ultimately, the tilt, modulation of the focal position, and frequency modulation can heat and possibly solidify the entire line having a length of about 2.86 mm.

[0204] In one embodiment, the polarized ceramic has a 2k x The spatial frequency, such as Fig. 9 As shown in . In this case, each electrical channel covers two polarization regions in a ceramic (e.g., a piezoelectric ceramic). If channels 1 to 8 have the same electrical phase, the spatial frequency of the aperture is 2k x If the phase alternates so that the odd channels have a phase of 0 degrees and the even channels have a phase of 180 degrees, then the spatial frequency of the aperture is k x In one embodiment, this configuration with only two phases possible on a channel enables four unique focal points. In various embodiments, if additional phases are allowable, 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.

[0205] In several embodiments, a treatment system utilizes multiple treatment channels to achieve electronic focusing and / or steering. For example, a treatment system that utilizes multiple treatment channels to achieve electronic focusing and / or steering allows for faster electronic dithering to produce more thermal coagulation using the same energy as other treatment devices, or produces equal thermal coagulation using electronic dithering with less energy than other treatment devices. This technology broadens the continuum of efficacy and comfort provided by the device. In addition to electronic dithering, multiple treatment channels can also move the beam to different depth locations, for example, two traditional transducers, such as DS7-4.5 (7MHz at 4.5mm depth) and DS7-3.0 (7MHz at 3.0mm depth), can be replaced by a single device that moves between two different depths.

[0206] In one embodiment, a transducer 280 (e.g., an annular array) having multiple treatment channels 281 connected to move the beam axially generally generates TCP 550 at a deep depth first 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 generates TCP 550 sequentially and will result in a prolonged treatment time. For example, in one embodiment, if the time for deep TCP 550 is t deep and the time for shallow TCP 550 is t shallow , then the total treatment time for the 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 forming multiple (two or more) TCPs 550 simultaneously using a signal mixing technique that uses signal apodization (masking) and phase control at each channel. In one embodiment, the total treatment time is t deep and t shallow The maximum value of:

[0207] Treatment time, conventional method: t treatment =t deep +t shallow

[0208] Treatment time, signal mixing: t treatment =max(t deep ,t shallow )

[0209] In an embodiment, the annular array design 280 enables electronic shifting of the treatment beam in depth (eg, by varying the depth of the TCP 550 below the skin surface). In one embodiment, the transducer 280 includes eight treatment channel annular transducer elements 281 with a fixed mechanical focus. Fig.10 A top view of one embodiment of the ceramic annular array design 280 is shown with the imaging transducer 285 in the center of the bowl. In this embodiment, the therapy annular transducer 280 has eight rings labeled Tx0 through Tx7, corresponding to elements 281.

[0210] Transducer

[0211] In one embodiment, the transducer 280 focuses spherically to one or more points. In one embodiment, the transducer 280 focuses cylindrically to one or more lines. Various embodiments of the transducer 280 include a flat piezo with a lens. In various embodiments, the transducer 280 includes a convex side 282 and a concave side 283. In various embodiments, the transducer 280 includes a convex side 282 and a concave side 283 with features that provide any one or more of variable depth, variable spacing, variable focal length positioning, with one, two, three, four or more simultaneous focal areas. In various embodiments, the transducer 280 is electrically connected to one or more tuning circuits. The tuning circuit improves the electrical signal between the console and the transducer. In various embodiments, the 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.

[0212] Fig.11 An embodiment of a transducer 280 is shown that includes a single element having a convex side 282 and a concave side 283 . Fig.12 An embodiment of a transducer 280 is shown that includes a solid coating convex side 282 and a striped concave side 283, wherein the strip includes a first polarization region and a second polarization region, wherein the polarization regions are positive, negative, or unpolarized. Fig.12 An embodiment of a transducer 280 is shown that includes a solid coated convex side 282 and a striped concave side 283, wherein the strip includes a first region and a second region, wherein the regions may or may not include a coating. In one embodiment, a single electrode is disposed on the convex surface, and a polarized strip on the concave surface is connected to two channels (e.g., Fig.12 ). The strips can be alternated to split the beam or include only one phase to simulate a conventional transducer. This will allow one transducer to simulate the processing of both the DS4-4.5S and DS4-4.5, thus producing three lines with one transducer placement.

[0213] Fig.13 An embodiment of a transducer 280 is shown including a striped 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 regions are positive, negative, or unpolarized. Fig.13An embodiment of a transducer 280 is shown that includes a striped convex side 282 and a solid coated concave side 283, wherein the strip includes a first region and a second region, wherein the regions may or may not include a coating. In various embodiments, the strips are electrically connected to one or more channels. In one embodiment, odd-numbered strips are connected to a first channel and even-numbered strips are connected to a second channel. In one embodiment, the first channel is maintained at 0° while the second channel alternates between 0° and 180° (or vice versa). The focused ultrasonic energy from the first channel is maintained at a single center location and the focused ultrasonic energy from the second (alternating) channel produces two spaced-apart focal regions. The focused ultrasonic energy from the first (constant) and second (alternating) channels together produce three simultaneous TCPs. In one embodiment, a single electrode is disposed on a concave surface and polarized strips on a convex surface are connected to two channels (e.g., Fig.13 ). The strips can be alternated to split the beam or include only one phase to simulate a traditional transducer. This will allow one transducer to simulate the processing of both the DS4-4.5S and DS4-4.5, thus producing three lines with one transducer placement.

[0214] Fig.14 An embodiment of a transducer 280 is shown including a striped convex side 282 and a striped concave side 283, wherein the strip includes a first polarization region and a second polarization region, wherein the polarization regions are positive, negative, or unpolarized, and wherein the striped regions are rotated in an orientation of approximately 90 degrees relative to each other. Fig.14 An embodiment of a transducer 280 is shown that includes a striped convex side 282 and a solid coated concave side 283, wherein the strip includes a first region and a second region, wherein the regions may or may not include a coating, and wherein the strips are rotated approximately 90 degrees relative to each other.

[0215] Fig.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 polarization region and a second polarization region, wherein the polarization regions are positive, negative or unpolarized. Fig.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 comprise a coating.

[0216] Fig.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 comprises a first polarization region and a second polarization region, wherein the polarization regions are positive, negative or unpolarized. Fig.16 An embodiment of a transducer 280 is shown that includes an annular convex side 282 and a strip-shaped concave side 283, wherein the strip includes a first region and a second region, wherein the regions may or may not include a coating.

[0217] In some embodiments, the system includes various features that exist as a single feature (as opposed to a plurality of features). For example, in one embodiment, the system comprises, consists essentially of, or includes a single ultrasound transducer element adapted to provide two simultaneous treatment areas via dithering. In alternative embodiments, multiple features or components are provided.

[0218] Simultaneous treatment at multiple depths

[0219] In various embodiments, the treatment system is configured to produce multiple microcoagulation areas in the tissue separated by 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' for the last two transducers indicates that the device is a narrow transducer, which is used in 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, a transducer with an annular electrode and a polarized ceramic is capable of frequency dithering in the lateral dimension, electronic dithering in the depth dimension, electronic focusing in the depth dimension, and a single transducer that can simulate DS10-1.5 (10 MHz at 1.5 mm depth), DS7-3.0 (7 MHz at 3.0 mm depth), DS7-4.5 (7 MHz at 4.5 mm depth), and DS4-4.5 (4 MHz at 4.5 mm depth) in one transducer. In one embodiment, optional tuning electronics can be used in combination with the composite ceramic to enable the transducer with an annular electrode and a polarized ceramic to achieve the functions of frequency dithering in the lateral dimension, electronic dithering 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 present in the transducer housing, between the transducer and the console, or in the console.

[0220] In one embodiment, a full facial treatment delivers 800 treatment lines with a transducer, which involves the operator moving a handpiece along the patient's skin over approximately 70 to 90 minutes. In one embodiment, a single treatment bowl is configured to deliver two treatment lines 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 comparable level of efficacy if operated at the correct energy. In various embodiments, simultaneous treatment reduces the overall pain of treatment. In one embodiment, the simultaneous treatment time is significantly shortened, assuming less overall pain of treatment.

[0221] In various embodiments, simultaneous treatment increases the speed of treatment by 10%, 20%, 25%, 30%, 40%, 50%, 60% or more. In various embodiments, simultaneous treatment reduces treatment time by 10%, 20%, 25%, 30%, 40%, 50%, 60% or more. In various embodiments, the system is configured to complete treatment time in 60, 50, 40, 30, 20 or 10 minutes or less.

[0222] In one embodiment, a simultaneous treatment system generates two lines simultaneously, with the ability to move the microcoagulation depth at the thermal coagulation zone 550. In one embodiment, the bandwidth of the treatment transducer is increased, and it is possible to have one device that behaves like two, three, four, five, or six fixed depth devices. In one embodiment, an 8 channel treatment device is used.

[0223] Fig.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 comprises a first polarization region and a second polarization region, wherein the polarization regions are positive, negative or unpolarized. Fig.17 An embodiment of a transducer 280 comprising an annular convex side 282 and a strip-like concave side 283 is shown, wherein the strip comprises a first region and a second region, wherein the regions may or may not comprise a coating. In one embodiment, an annular array coupled with simultaneous transducers enables transducers to be positioned at different depths 279 (e.g., D1, D2, D3, ... D N) simultaneously produces two focused ultrasound treatment lines. 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, the depth 279 is 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 any point within the range of 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 produces multiple thermal coagulation zones 550 at different depths 279. Fig.17 Both sides of an embodiment of a simultaneous treatment bowl are shown. On one side of the treatment bowl are strips used to perform alternating polarization. In one embodiment, the strips are on the concave side 283. In one embodiment, the strips are on the convex side 282. In one embodiment, after the polarization is completed, the electrodes are peeled off and a complete electrode is placed on the entire side. In one embodiment, a cold silver electrode can 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 be of equal area. The annular array enables beam movement in depth when the correct phase is applied to the treatment bowl.

[0224] In one embodiment, the transducer 280 including the annular convex side 282 and the strip-shaped concave side 283 is configured to produce a multi-depth thermal coagulation zone 550 at various depths 279, such as Fig.18 (projected in xyz space), Fig.19 (xz plane) and Fig. 20 (yz plane). Fig.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 contemplated that a deeper microcoagulation point (e.g., 4.5 mm) is first produced before moving to the next depth (e.g., 3.0 mm) and then finally moving 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 temperature of the skin may be limited by forming a microcoagulation point at the deepest depth (e.g., 4.5 mm) when moving from left to right and then placing the next depth (e.g., 3.0 mm) when moving from right to left and then completing the treatment with the microcoagulation point at the shallowest depth (e.g., 1.5 mm) when moving from left to right again. Fig.19 Projections of the treatment along the direction (x-axis) and depth (z-axis) of mechanical motion are shown. Fig. 20 Projections of the treatment along the direction (y-axis) and depth (z-axis) of the beam split are shown.

[0225] Figure 21-23 An embodiment of a simultaneous multi-depth treatment device is shown, which is configured to produce TCP at depths of 1.5 mm, 3.0 mm, and 4.5 mm, with intermediate layers deviating between deep and shallow depths. In one embodiment, a transducer 280 including an annular convex side 282 and a strip-shaped concave side 283 is configured to produce multiple deep thermal coagulation zones 550 at various depths 279, such as Fig.21 (projected in xyz space), Fig. 22 (xz plane) and Fig.23 (yz plane). In one embodiment, the length of the TCP may limit the ability to stack multiple depths of TCP directly on top of each other. In one embodiment, the motion mechanism offsets TCP treatments of different depths from each other. Fig.21 A three-dimensional diagram of an offset multi-depth transducer is shown. Figure 18-20 A similar delivery process as described can be applied to Figure 21-23 Embodiments in which the micro-solidification points can be delivered while moving from left to right or right to left to minimize the possibility of any potential damage to the epidermis or dermis or tissue layers. Fig. 22 Projections of delivery along mechanical motion (x-axis) and depth (z-axis) are shown. This clearly shows the mid-layer of TCP being offset from deep and shallow treatments. Fig.23 Projections of delivery along the direction (y-axis) and depth (z-axis) of the beam split are shown.

[0226] Figure 24-26An embodiment of a simultaneous multi-depth treatment device is shown, configured to produce TCPs at depths of 1.5 mm, 3.0 mm, and 4.5 mm, with intermediate layers offset from shallow depths at varying pitches. In one embodiment, a motion mechanism can be used to match the separation distance between TCPs in a single line treatment. Figure 24-26 A three-dimensional sketch of a multi-depth simultaneous treatment is shown. In this case in an embodiment, a 4.5 mm depth treatment is delivered at one pitch (1.5 mm apart), while a 3.0 mm depth and a 1.5 mm depth treatment are delivered at another pitch (e.g., 1.1 mm apart). Although the 1.5 mm depth and 3.0 mm depth treatments are at the same pitch (e.g., 1.1 mm), the motion mechanism allows an offset to be applied to prevent stacking of micro-coagulation points. Fig.25 Projections of delivery along mechanical motion (x-axis) and depth (z-axis) are shown. This clearly shows that the middle layer of the TCP is offset from the shallow treatment, even though the pitch is the same. Similarly, the deepest treatment is at a slightly larger pitch relative to the other two depths. Fig.26 Projections of delivery along the direction (y-axis) and depth (z-axis) of the beam split are shown.

[0227] In various embodiments, a transducer 280 (eg, Fig.16 and / or Fig.17 ) produces Fig.25 , 26 and / or the treatment mode shown in the embodiments of 29. In an embodiment, 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 area when viewed in a projection in xyz space (e.g., at Fig.18 and 19 ), where the control of each ring in the annular convex side 282 has an amplitude (A) and a phase (θ). In this case, simultaneous focus is generated at one depth based on the polarization of the strips. To generate simultaneous focus at each depth, as Fig.18 and 19 As shown in , a different phase (θ) and a different amplitude (A) are applied to each ring in order to produce simultaneous focuses at different depths. The different phases enable the two focuses to be moved to different focal depths, and the different amplitudes allow the focus intensity to vary and therefore change the heating rate in the tissue. The amount of separation between two focuses at the same depth along the Y axis is determined by the frequency, focal depth, and spatial frequency of the strip (see Eq. 14, where s is solved). The transducer can be moved manually or mechanically to precisely space the simultaneous focuses along the X axis. In one embodiment, the middle ring has an amplitude A1 that is greater than the next outer ring having an amplitude A2, which is greater than A3, ... until the outermost ring has an amplitude A n, producing a wider intensity range and being able to be shaped into two foci occurring simultaneously. This amplitude control allows for variations in the beam width at both foci as well as the intensity affecting the heating rate.

[0228] In various embodiments, a continuous wave function can be used to generate simultaneous focal regions at different depths below the skin surface, which combines the excitation function of the focusing solution with another solution. In one embodiment, a focal region (f1) at a first depth (d1) is generated simultaneously with a second focal region (f2) at a second depth (d2) different from the first depth (d1). Two focal points at different depths (d1 and d2) can be generated simultaneously via a linear system that combines excitation with a single ultrasonic transducer element. The following table shows the two sets of amplitudes and phases required for each focal region 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. Assume that the excitation on ring No. 1 for focus #1 is written as:

[0229] x 1，1 (t) = A 1，1 sin(ωt+θ 1，1 )

[0230] Assume that the excitation on ring 1 at focus #2 is written as:

[0231] x 1，2 (t) = A 1，2 sin(ωt+θ 1，2 )

[0232] where ω is 2πf, where f is frequency and t is time.

[0233]

[0234]

[0235] In order to produce two focal points simultaneously at two different depths, the two excitations of the first ring must be combined:

[0236] X1(t)=x 1，1 (t)+x 1，2 (t) = A 1，1 sin(ωt+θ 1，1 )+A 1，2 sin(ωt+θ 1，2 )

[0237] However, even though this is the necessary excitation on loop 1, it is not clear what the actual amplitude and phase required on the loop is to properly excite both f1 and f2 simultaneously. To determine this new amplitude (Λ1) and new phase (Ω1) of the combined effect, the following trigonometric identities apply:

[0238] Λ1=sqrt([A 1，1 cos(θ 1，1 )+A 1，2 cos(θ 1，2 )] 2 +[A 1，1 sin(θ 1，1 )+A 1，2 sin(θ 1，2 )] 2 )Ω1=tan -1 [(A 1，1 sin(θ 1，1 )+A 1，2 sin(θ 1，2 )) / (A 1，1 cos(θ 1，1 )+A 1，2 cos(θ 1，2 ))] so that the new excitation on loop 1 is:

[0239] X1(t)=Λ1sin(ωt+Ω1)

[0240] The same process can be applied to the other rings to obtain the array solution to produce f1 and f2 simultaneously. Similarly, if it is desired to deliver three or more foci simultaneously, the process can be repeated using the above identities until only one excitation and one phase are calculated for each ring. For example, assuming the goal is to produce three foci simultaneously, the initial new amplitude and new phase for each ring are calculated based on the amplitude and phase required for focus 1 and focus 2. Next, these new amplitudes and phases are combined with the ring excitation required for focus 3.

[0241] Although simultaneous foci can be generated using this approach, the necessary amplitude may be limited by the saturation of the piezoelectric material and the ability of the tissue to absorb the increased intensity in the surrounding tissue when multiple foci are generated. These physical limitations must be compared with the temporal advantages of generating simultaneous foci.

[0242] Figure 27-29 An embodiment of a simultaneous multi-depth treatment device is shown, configured to produce TCP at depths of 1.5 mm, 3.0 mm, and 4.5 mm, with intermediate layers offset from shallow depths and frequencies used to produce different separation distances at each depth. Figure 24-26 In various embodiments, the amount of separation between TCPs that occurs simultaneously depends on the treatment frequency. In one embodiment, the device is capable of delivering treatment at multiple frequencies (e.g., with a broadband treatment transducer), and the frequency can be used to modulate the distance between TCPs. Fig.18As discussed, the spacing of the strips is determined at the time of manufacture, as this is produced by the ceramic polarization. Lower frequencies and greater depths produce wider separations between the TCPs (yz plane) produced simultaneously. Figure 4 A three-dimensional matrix of TCPs with these different degrees of separation is shown. As the frequency at shallower depths increases and the treatment depth decreases, the distance between the simultaneously generated TCPs decreases. Fig.28 Projections of delivery along mechanical motion (x-axis) and depth (z-axis) are shown. This clearly shows the shift in the middle layer of the TCP from shallow and deep treatments, even though the pitch is the same. Fig.29 A projection of the delivery along the direction (y-axis) and depth (z-axis) of beam splitting is shown. The projection shows that the spacing between TCPs becomes progressively larger as the treatment depth increases, which is mainly due to the depth and frequency changes in the treatment.

[0243] In one embodiment, Fig.29 As shown in , different intervals can be generated by changing the frequency and focal depth. For example, Equation 14 is:

[0244] s=(2k x z f λ) / (2π)

[0245] Where s is the separation between two simultaneous foci at the same depth. This equation shows that the focus separation is a function of the depth of focus (zf) and the frequency (since λ is the speed of sound divided by the frequency). Assume that the same frequency and spatial frequency across the strip are used. The table summarizes the separation of different foci separated by 1.5 mm.

[0246]

[0247]

[0248] However, if the frequency is varied so that higher frequencies are used for the shallowest focus, a wider range of separation distances can be achieved:

[0249] zf(mm) Frequency (MHz) Wavelength(mm) kx(mm^-1) s(mm) 15.5 10 0.154 1.5 1.140 17 7 0.22 1.5 1.786 18.5 4 0.385 1.5 3.401

[0250] In various embodiments, different w (e.g., w1, w2) can be used to change the distance or spacing. In various embodiments, a continuous wave function can be used to generate simultaneous focal regions at different depths below the skin surface, which combines frequency with Fourier transforms. In one embodiment, a focal region (f1) at a first depth (d1) is generated simultaneously with a second focal region (f2) at a second depth (d2) different from the first depth (d1). Two focal points at different depths (d1 and d2) can be generated simultaneously via a linear system that combines the excitation of a single ultrasonic transducer element.

[0251]

[0252] Where X1=excitation(A,θ)=A 1,1 sin(w1t-θ 1,1 )A 1,2 sin(w2t-θ 1,2 ) to produce two simultaneous focal points at different distances.

[0253] In various embodiments, the electrostrictor exhibits piezoelectric behavior when a sufficient DC bias is applied to the material. In one embodiment, the strength of the piezoelectric behavior is proportional to the acoustic sensitivity. In one embodiment, the electrostrictive material is used with the treatment bowl during the manufacturing process. In one embodiment, patterning and electrode attachment are achieved during manufacturing, but polarization of the electrostrictor is completed during treatment delivery. For example, in one embodiment, the transmit aperture can be as follows: Fig.37 The square wave shown in , or masked by modifying the high voltage value. Fig.30 An embodiment of a simultaneous multi-depth treatment device is shown, which is configured to produce TCP at depths of 1.5 mm, 3.0 mm, and 4.5 mm, wherein the annular array is coupled to an electrostrictor capable of simultaneously producing multiple pairs of electrostrictors at different depths. In one embodiment, the electrostrictor varies the spatial frequency (e.g. Fig.37 ) to provide for the generation of therapeutic lines (e.g. Fig.34 In one embodiment, the electrostrictor generates a treatment line without a mechanical motion mechanism. In one embodiment, the electrostrictor generates a line perpendicular to the motion of the mechanical motion mechanism. Thus, in various embodiments, multi-dimensional treatment can generate one, two, or more treatment focal areas in various intervals, lines, planes, or three-dimensional spaces. In some embodiments, the electrostrictor causes ions in the lattice of the piezoelectric transducer to displace when exposed to an external electric field. In various embodiments, Figure 17-29 There is a fixed polarization pattern to produce a separation distance between two TCPs generated simultaneously. This is because the polarization pattern is generated in the piezoelectric ceramic during the manufacturing process. The spacing between the strips determines the spacing between the TCPs. The greater the distance between the strips, the closer the TCPs are. In some embodiments, the distance between the strips cannot be changed after the polarization is completed. In one embodiment, as Figure 30-33 As shown in FIG, the electrically insulating material does not involve polarization, but rather uses an electrostrictor to apply a direct current (DC) voltage during device operation to exhibit piezoelectric behavior that can be used to improve device performance. FIG. Sa shows the front and back sides (e.g., concave and convex sides) of a ceramic bowl, which is similar to Fig.17 In one embodiment, the annular mode is on the back side (eg, convex side) of the transducer. Fig.17The front side (patient side, e.g., concave side) is slightly different compared to the embodiments in, for example, the strips appear to be produced with a finer pitch. Secondly, the ceramic is not polarized, but rather the connections from each individual strip are connected to an independent set of electronics that apply a voltage across the strips to produce an appropriate pattern that produces a separation distance between the TCPs. In one embodiment, the voltage varies at a high spatial frequency, resulting in a larger separation distance between the TCPs. The electronics allow this pattern to be varied so that the distance between the TCPs can also be varied. The result is a collection of simultaneous TCPs that can be produced by this 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. Fig.31 An example of the type of TCP distribution that can be generated in three dimensions is shown. In an example, five TCPs are generated at each depth, which are achieved with three different DC amplitude modulation patterns on the strip. Again, the sequence can vary within the depth 279 or at each depth based on the movement of the motion mechanism from left to right or right to left, the modulation pattern, and the focusing of the ring. The sequence used is based on the safe tolerance of the epidermis and dermis, as well as any other tissue layers, and the goal of delivering the TCPs as quickly as possible. Fig.32 Projections of delivery along mechanical motion (x-axis) and depth (z-axis) are shown. Fig.33 A projection of the delivery along the direction (y-axis) and depth (z-axis) of beam splitting is shown. The projection shows five TCPs generated in the plane. Two pairs of TCPs are generated simultaneously, one pair 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.

[0254] Figure 34-36 An embodiment of a simultaneous multi-depth treatment device is shown, configured to produce TCP at depths of 1.5 mm, 3.0 mm, and 4.5 mm, wherein an annular array coupled to a simultaneous treatment transducer enables the simultaneous production of two lines at different depths. In one embodiment, an advantage of using an electrostrictor with sufficient strips is the ability to produce thermal treatment lines if the pattern is changed rapidly. Fig.34 An embodiment is shown showing three-dimensional TCP lines generated using multiple spatial frequencies of the electrostrictor mode at only one depth. Depending on the rate of pattern change across the strip, the heating can be varied to produce microcoagulation lines or hyperthermic lines, which are tissues for apoptosis. Fig.35 The projection onto the xz plane is shown, which takes into account five lines. Fig.36 A projection onto the yz plane is shown, which shows the heating line along the y-axis at a specific depth.

[0255] In one embodiment, Fig.37shows the different patterns that can be generated when the stripes have a fine pitch. Fig.37 In the figure, the X-axis represents the distance across the transducer. The Y-axis represents the DC amplitude at the position across the transducer. In various embodiments, various DC signals applied across the transducer can result in different intervals between the focal points. In one embodiment, the detail pitch is related to the splitting distance, operating frequency, and focal depth that are attempted to be achieved. In various embodiments, the detail pitch is between 0.1 mm and 0.05 mm (e.g., 100 microns to 50 microns, including 90, 80, 70, 60 microns and any value therein). The figure shows amplitude modulation at different intervals that may produce micro-coagulation points along the y-axis. Although the figure covers factors of 2, other modulation modes between the multiples shown may be available. 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 DC bias.

[0256] 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 swapping 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 TCPs delivered simultaneously. In one embodiment, the advantage is maintaining the pitch separation of 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 one transducer placed on the patient's body. In one embodiment, the advantage of using an electrostrictor is modulating the distance between TCPs delivered simultaneously. In one embodiment, the advantage is the ability to modulate the attenuation of spatial high frequency harmonics from the simultaneous treatment modulation mode. In one embodiment, the advantage of using an electrostrictor provides the possibility of adding zeros to the modulation mode.

[0257] Example Embodiments

[0258] The following examples are non-limiting embodiments.

[0259] In some embodiments, there is provided an ultrasound treatment system for generating multiple focal points and different depths with an ultrasound transducer, the system comprising: an ultrasound probe, the ultrasound probe comprising an ultrasound transducer, the ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations with at least one of the group consisting of amplitude modulation polarization and phase shift; a moving mechanism, the moving mechanism configured to be programmed to provide a plurality of separate thermal cosmetic treatment areas with intervals between; wherein the sequence of separate cosmetic treatment areas has a treatment interval in the range of 1 mm to 50 mm; and a control module coupled to the ultrasound probe to control the ultrasound transducer, wherein the ultrasound transducer is configured to provide an acoustic power of ultrasound treatment in the range of 10 W to 1000 W and a frequency of 1 MHz to 20 MHz to heat tissue by heat to cause coagulation. The plurality of locations can be positioned in a substantially linear sequence within the cosmetic treatment area, and the ultrasound transducer comprises a single ultrasound transducer element. In one embodiment, a first group of locations are positioned within a first cosmetic treatment area, and a second group of locations are positioned within a second cosmetic treatment area, the first area being different from the second area. The first cosmetic treatment area may comprise a generally linear sequence of a first set of locations and the second cosmetic treatment area may comprise a generally linear sequence of said second set of locations.

[0260] In one embodiment, the ultrasonic transducer is configured to apply ultrasonic therapy using amplitude modulation, whereby multiple portions of the transducer are configured to emit ultrasonic therapy at multiple acoustic intensity amplitudes, wherein the first amplitude is different from the second amplitude. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic therapy phase shifts, whereby multiple portions of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple acoustic intensity phases, where the first phase is different from the second phase. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic therapy using amplitude modulation, whereby multiple portions of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple acoustic intensity amplitudes, where the first amplitude is different from the second amplitude; and configured to apply ultrasonic therapy phase shifts, whereby multiple portions of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple acoustic intensity phases, where the first phase is different from the second phase. The multiple phases include discrete phase values. The ultrasonic transducer may include a piezoelectric material, and the multiple portions of the ultrasonic transducer may be configured to generate multiple corresponding piezoelectric material changes in response to an electric field applied to the ultrasonic transducer. In one embodiment, the multiple piezoelectric material changes include at least one of an expansion of the piezoelectric material and a contraction of the piezoelectric material. The ultrasound treatment system may include at least a portion of an ultrasound transducer configured to emit ultrasound treatment at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasound treatment emitted by the at least a portion of the piezoelectric varies over time. In one embodiment, the moving mechanism is configured to be programmed to provide variable spacing between a plurality of separate thermal cosmetic treatment zones, and further includes one or more selectable tuning circuits. The ultrasound treatment system may include a sequence of separate cosmetic treatment zones, the sequence of separate cosmetic treatment zones having treatment spacings in the range of 1 mm to 25 mm, and further includes a tuning circuit. In one embodiment, the ultrasound treatment is at least one of a face lift, a brow lift, a chin lift, an eye treatment, wrinkle reduction, scar reduction, burn treatment, skin tightening, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, cellulite treatment, shoulder treatment, vaginal rejuvenation, and acne treatment. The ultrasound treatment system may include an ultrasound transducer configured to provide an acoustic power of ultrasound treatment in the range of between 10 W to 100 W and a frequency of 1 MHz to 12 MHz to heat tissue by heat to cause coagulation.

[0261] In several embodiments, a treatment system for simultaneously generating multiple focal points at different depths with an ultrasound transducer is provided, the system comprising an ultrasound probe, the ultrasound probe comprising: a first switch operable to control an ultrasound imaging function for providing ultrasound imaging; a second switch operable to control an ultrasound treatment function for providing ultrasound treatment; and a moving mechanism configured to direct the ultrasound treatment in at least one sequence of separate thermal cosmetic treatment areas; and a transducer module configured to apply the ultrasound treatment with at least one of the group consisting of amplitude modulation polarization and phase shift, wherein the transducer module is configured for ultrasound imaging and ultrasound treatment, wherein the transducer module is configured to be coupled to the ultrasound probe, wherein the transducer module comprises an ultrasound transducer, the ultrasound transducer is configured to apply the ultrasound treatment to tissue at a plurality of locations having at least two focal depths, wherein the transducer module is configured to be operably coupled to at least one of the first switch, the second switch and the moving mechanism; and a control module, wherein the control module comprises a processor and a display for controlling the transducer module. In one embodiment, the ultrasound treatment is a cosmetic treatment, wherein the plurality of locations are positioned in a substantially linear sequence within the cosmetic treatment area. The treatment system may include ultrasound treatment as a cosmetic treatment, wherein a first set of positions are positioned within a first treatment area and a second set of positions are positioned within a second treatment area, the first area being different from the second area. In one embodiment, the first treatment area comprises a substantially linear sequence of the first set of positions, and the second treatment area comprises a substantially linear sequence of the second set of positions. The transducer module may be configured to apply the ultrasound treatment using amplitude modulation, whereby multiple portions of the transducer module are configured to transmit the ultrasound treatment at multiple acoustic intensity amplitudes, where the first amplitude is different from the second amplitude. In one embodiment, the transducer module is configured to apply an ultrasound treatment phase shift, whereby multiple portions of the transducer module are configured to transmit the ultrasound treatment at multiple acoustic intensity phases, where the first phase is different from the second phase. The transducer module may be configured to: apply the ultrasound treatment using amplitude modulation, whereby multiple portions of the transducer module are configured to transmit the ultrasound treatment at multiple acoustic intensity amplitudes, where the first amplitude is different from the second amplitude; and apply an ultrasound treatment phase shift, whereby multiple portions of the transducer module are configured to transmit the ultrasound treatment at multiple acoustic intensity phases, where the first phase is different from the second phase. In one embodiment, the multiple phases comprise discrete phase values. The transducer module includes a piezoelectric material, and the plurality of portions of the transducer module are configured to generate a plurality of corresponding piezoelectric material changes in response to an electric field applied to the transducer module. In one embodiment, the plurality of piezoelectric material changes include at least one of expansion of the material and contraction of the material. The treatment system may include at least a portion of the transducer module configured to transmit ultrasound treatment at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasound treatment transmitted by at least a portion of the transducer module varies over time.In one embodiment, the moving mechanism is configured to be programmed to provide variable spacing between multiple individual thermal cosmetic treatment areas. The treatment system may include a sequence of individual thermal cosmetic treatment areas, the sequence of individual thermal cosmetic treatment areas having treatment spacings in the range of 1 mm to 25 mm. In one embodiment, the first and second switches include user-operated buttons or keys. The treatment system may include at least one of the first switch and the second switch, the at least one of which is activated by the control module. In one embodiment, the treatment function is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, cellulite treatment, shoulder treatment, vaginal rejuvenation, and acne treatment. The transducer module may be configured to provide an acoustic power of ultrasound treatment in the range of between 10 W to 1000 W and a frequency of 1 MHz to 20 MHz to heat the tissue by heat to cause coagulation.

[0262] In several embodiments, a treatment system for delivering simultaneous treatment at multiple depths comprises: a control device operable to control an ultrasound treatment function for providing ultrasound treatment; and a cane configured to direct the ultrasound treatment in a sequence of separate thermal cosmetic treatment zones, the cane comprising: a transducer configured to apply the ultrasound treatment to a location at a depth of focus, the location being positioned within the thermal cosmetic treatment zone, wherein the transducer is further configured to simultaneously apply the ultrasound treatment to tissue at multiple locations at the depth of focus.

[0263] In several embodiments, a method for performing a non-invasive cosmetic procedure on the skin by producing multiple simultaneous focal points at multiple depths with a single transducer, the method comprising: coupling a transducer module to an ultrasound probe; wherein the ultrasound probe includes a first switch that controls acoustic imaging; wherein the ultrasound probe includes a second switch that controls acoustic therapy for causing multiple separate cosmetic treatment areas; wherein the ultrasound probe includes a movement mechanism that provides desired spacing between the separate cosmetic treatment areas; bringing the transducer module into contact with the skin surface of a subject; activating the first switch on the ultrasound probe to acoustically image an area below the skin surface with the transducer module; and activating the second switch on the ultrasound probe to acoustically treat an area below the skin surface with the transducer module in a desired sequence of separate cosmetic treatment areas controlled by the movement mechanism, wherein the transducer module includes a single ultrasound transducer configured to apply ultrasonic therapy to tissue at multiple focal depths.

[0264] In several embodiments, an ultrasound treatment system for simultaneously generating multiple focal points at multiple depths in tissue with an ultrasound transducer comprises: a control device operable to control an ultrasound treatment function for providing ultrasound treatment; and a cane configured to direct the ultrasound treatment in a sequence of separate thermal cosmetic treatment areas, the cane comprising: a transducer configured to apply ultrasound treatment to tissue at multiple locations at the focal depth. In one embodiment, non-invasive cosmetic treatment is performed on the skin.

[0265] In several embodiments, an imaging and treatment system for cosmetic treatment at multiple depths in tissue, the system comprising: an ultrasound probe configured for ultrasound imaging and ultrasound treatment of tissue at multiple focal depths, comprising: a transducer module configured for coupling to the ultrasound probe, wherein the transducer module comprises an ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations at the focal depth, a first switch operable to control an ultrasound imaging function for providing ultrasound imaging; a second switch operable to control an ultrasound treatment function for providing ultrasound treatment; and a movement mechanism configured to direct the ultrasound treatment in at least one sequence of separate thermal cosmetic treatment zones; and wherein the transducer module is configured to be operably coupled to at least one of the first switch, the second switch, and the movement mechanism; and a control module, wherein the control module comprises a processor and a display for controlling the transducer module. In one embodiment, the multiple locations are positioned in a cosmetic treatment zone in a substantially linear sequence. The imaging and treatment system may include a first set of locations positioned in a first cosmetic treatment zone and a second set of locations positioned in a second cosmetic treatment zone, the first zone being different from the second zone. In one embodiment, the first cosmetic treatment zone comprises a substantially linear sequence of the first set of locations, and the second cosmetic treatment zone comprises a substantially linear sequence of the second set of locations. The transducer module can be configured to apply ultrasound therapy using amplitude modulation, whereby multiple portions of the transducer module are configured to emit ultrasound therapy at multiple acoustic intensity amplitudes, where the first amplitude is different from the second amplitude. In one embodiment, the transducer module is configured to apply ultrasound therapy phase shifts, whereby multiple portions of the transducer module are configured to emit ultrasound therapy at multiple acoustic intensity phases, where the first phase is different from the second phase. The transducer module can be configured to apply ultrasound therapy using amplitude modulation, whereby multiple portions of the transducer module are configured to emit ultrasound therapy at multiple acoustic intensity amplitudes, where the first amplitude is different from the second amplitude; and apply ultrasound therapy phase shifts, whereby multiple portions of the transducer module are configured to emit ultrasound therapy at multiple acoustic intensity phases, where the first phase is different from the second phase. In one embodiment, the multiple phases include discrete phase values. The transducer module includes a piezoelectric material, and the multiple portions of the transducer module are configured to generate multiple corresponding piezoelectric material changes in response to an electric field applied to the transducer module. In one embodiment, the multiple piezoelectric material changes include at least one of expansion of the material and contraction of the material. At least a portion of the transducer module may be configured to emit ultrasound treatment at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasound treatment emitted by at least a portion of the transducer module varies over time. In one embodiment, the movement mechanism is configured to be programmed to provide variable spacing between a plurality of separate thermal cosmetic treatment zones. The sequence of separate thermal cosmetic treatment zones has a treatment spacing in the range of 0.01 mm to 25 mm. In one embodiment, the first and second switches comprise user-operated buttons or keys.At least one of the first switch and the second switch is activated by the control module. In one embodiment, the therapeutic function is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, vaginal rejuvenation, and acne treatment. The transducer module can be configured to provide an acoustic power of ultrasound therapy in a range between 10 W to 1000 W and a frequency of 1 MHz to 10 MHz to heat tissue by heat to cause coagulation.

[0266] In several embodiments, a multi-focus ultrasound treatment system for simultaneous treatment at multiple depths includes: a control device operable to control an ultrasound treatment function for providing ultrasound treatment; and a cane configured to direct the ultrasound treatment in a sequence of separate thermal cosmetic treatment zones, the cane including: a transducer configured to apply ultrasound treatment to tissue at a location at the focal depth, the location being positioned within the thermal cosmetic treatment zone, wherein the transducer is further configured to simultaneously apply ultrasound treatment to tissue at multiple locations at the focal depth.

[0267] In several embodiments, an imaging and simultaneous multi-focal therapy system at multiple depths comprises: a module comprising an ultrasound transducer, wherein the ultrasound transducer is configured to apply ultrasound therapy to tissue at multiple focal depths with at least one of the group consisting of amplitude modulated polarization and phase shift, wherein the module further comprises an interface guide designed to be removably coupled to a cane to provide electronic communication and power between the module and the cane. In one embodiment, the plurality of locations are positioned in a substantially linear sequence within a cosmetic treatment region. A first set of locations may be positioned within a first cosmetic treatment region, and a second set of locations may be positioned within a second cosmetic treatment region, the first region being different from the second region. In one embodiment, the first cosmetic treatment region comprises a substantially linear sequence of the first set of locations, and the second cosmetic treatment region comprises a substantially linear sequence of the second set of locations. The ultrasound transducer may be configured to apply ultrasound therapy using amplitude modulation, whereby multiple portions of the ultrasound transducer are configured to emit ultrasound therapy at multiple acoustic intensity amplitudes, whereby the first amplitude is different from the second amplitude. In one embodiment, the ultrasound transducer is configured to apply ultrasound therapy phase shifts, whereby multiple portions of the ultrasound transducer are configured to emit ultrasound therapy at multiple acoustic intensity phases, whereby the first phase is different from the second phase. The ultrasonic transducer can be configured to apply ultrasonic treatment using amplitude modulation, whereby multiple portions of the ultrasonic transducer are configured to transmit ultrasonic treatment at multiple acoustic intensity amplitudes, wherein the first amplitude is different from the second amplitude; and apply ultrasonic treatment phase shift, whereby multiple portions of the ultrasonic transducer are configured to transmit ultrasonic treatment at multiple acoustic intensity phases, wherein the first phase is different from the second phase. In one embodiment, the multiple phases include discrete phase values. The ultrasonic transducer may include a piezoelectric material, and the multiple portions of the ultrasonic transducer are configured to generate multiple corresponding piezoelectric material changes in response to an electric field applied to the ultrasonic transducer. In one embodiment, the multiple piezoelectric material changes include at least one of expansion of the piezoelectric material and contraction of the piezoelectric material. At least a portion of the ultrasonic transducer can be configured to transmit ultrasonic treatment at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic treatment emitted by at least a portion of the piezoelectric device varies over time. In one embodiment, the imaging and treatment system also includes a moving mechanism configured to be programmed to provide spacing between multiple separate cosmetic treatment areas. The sequence of separate cosmetic treatment areas can have a treatment spacing in the range of 1 mm to 50 mm. In one embodiment, the ultrasound treatment is at least one of a face lift, a brow lift, a chin lift, an eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, vaginal rejuvenation, and acne treatment. The ultrasound transducer may be configured to provide an acoustic power for ultrasound treatment in the range of 1 W to 100 W and a frequency of 1 MHz to 10 MHz to heat tissue by heat to induce coagulation.

[0268] In several embodiments, a treatment system for simultaneous treatment at multiple depths includes: a control device operable to control an ultrasound treatment function for providing ultrasound treatment; and a cane configured to direct the ultrasound treatment in a sequence of separate thermal cosmetic treatment areas, the cane including: a transducer configured to simultaneously apply ultrasound treatment to tissue at multiple locations at the focal depth.

[0269] In several embodiments, a non-invasive method for performing cosmetic surgery simultaneously at multiple depths that is not performed by a physician comprises: coupling a transducer module to an ultrasound probe; wherein the transducer module comprises an ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations at a focal depth with at least one of a group consisting of amplitude modulated polarization and phase shift, wherein the ultrasound probe comprises a first switch to control acoustic imaging; wherein the ultrasound probe comprises a second switch to control the acoustic treatment for causing multiple separate cosmetic treatment areas; wherein the ultrasound probe comprises a movement mechanism to provide a desired spacing between the separate cosmetic treatment areas; bringing the transducer module into contact with a skin surface of a subject; activating the first switch on the ultrasound probe to acoustically image an area below the skin surface with the transducer module; and activating the second switch on the ultrasound probe to acoustically treat an area below the skin surface with the transducer module in a desired sequence of separate cosmetic treatment areas controlled by the movement mechanism.

[0270] In several embodiments, the imaging and treatment system is used for non-invasive cosmetic treatment of the skin.

[0271] In several embodiments, an ultrasound treatment system for dithering multiple simultaneous focal points from an ultrasound transducer at multiple depths includes an ultrasound probe, the ultrasound probe comprising: an ultrasound transducer having a single transducer element, the single transducer element adapted to simultaneously apply ultrasound treatment to tissue at multiple intervals of focal depths, wherein the ultrasound transducer is polarized with at least a first polarization configuration and a second polarization configuration, a control module coupled to the ultrasound probe for controlling the ultrasound transducer, wherein the control module modifies the intervals between the interval positions via dithering of a first focal region and a second focal region, such that the position of the beam focus is precisely moved at the interval positions via frequency modulated dithering. The multiple positions may be positioned within a cosmetic treatment region in a linear sequence, wherein the interval positions are separated by intervals via frequency oscillation dithering. In one embodiment, a first set of positions are positioned within a first cosmetic treatment region and a second set of positions are positioned within a second cosmetic treatment region, the first region being different from the second region. The ultrasound transducer may be adapted to apply the ultrasound treatment using amplitude modulation, whereby multiple portions of the ultrasound transducer are adapted to transmit the ultrasound treatment at multiple acoustic intensity amplitudes, wherein the first amplitude is different from the second amplitude. In one embodiment, at least a portion of the ultrasonic transducer is adapted to transmit ultrasonic therapy at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic therapy transmitted by at least a portion of the piezoelectric varies over time. The ultrasonic transducer may include a piezoelectric material, and multiple portions of the ultrasonic transducer are adapted to produce multiple corresponding piezoelectric material changes in response to an electric field applied to the ultrasonic transducer. In one embodiment, the multiple piezoelectric material changes include at least one of an expansion of the piezoelectric material and a contraction of the piezoelectric material. The ultrasonic transducer may be adapted to apply ultrasonic therapy via phase shifting, whereby multiple portions of the ultrasonic transducer are adapted to transmit ultrasonic therapy at multiple acoustic intensity phases, where the first phase is different from the second phase. In one embodiment, the multiple phases include discrete phase values. The ultrasonic transducer may be adapted to apply ultrasonic therapy using amplitude modulation, whereby multiple portions of the ultrasonic transducer are adapted to transmit ultrasonic therapy at multiple acoustic intensity amplitudes, where the first amplitude is different from the second amplitude; and apply ultrasonic therapy, whereby multiple portions of the ultrasonic transducer are adapted to transmit ultrasonic therapy at multiple acoustic intensity phases, where the first phase is different from the second phase. In one embodiment, the ultrasound treatment is at least one of: face lift, brow lift, chin lift, eye treatment, wrinkle reduction, shoulder enhancement, butt lift, scar reduction, burn treatment, skin tightening, blood vessel reduction, treating sweat glands, sun spot removal, fat treatment, abdominal relaxation treatment, and cellulite treatment. The ultrasound probe may include a movement mechanism adapted to guide the ultrasound treatment in at least one pair of simultaneous sequences of separate thermal cosmetic treatment areas. In one embodiment, the ultrasound probe is configured for ultrasound imaging and ultrasound treatment. The ultrasound probe may include a transducer module adapted to apply the ultrasound treatment.

[0272] In several embodiments, an ultrasound treatment system for dithering multiple simultaneous focal points at multiple depths from an ultrasound transducer in a cosmetic treatment, the system comprising an ultrasound probe, the ultrasound probe comprising: a control module adapted to modify the spacing between a first focal region and a second focal region via dithering, operable to control a switch of an ultrasound treatment function for providing ultrasound treatment; and a moving mechanism adapted to direct the ultrasound treatment in at least one pair of simultaneous sequences of separate thermal cosmetic treatment regions; and a transducer module adapted to apply ultrasound treatment, wherein the transducer module is adapted to be coupled to the ultrasound probe, wherein the transducer module comprises an ultrasound transducer adapted to apply ultrasound treatment to tissue at multiple locations having at least two focal depths, wherein the transducer module is adapted to be operably coupled to at least one of the switch and the moving mechanism; and wherein the control module comprises a processor and a display for controlling the transducer module. In one embodiment, the transducer module is adapted to apply ultrasound treatment using amplitude modulation, whereby multiple portions of the transducer module are adapted to transmit ultrasound treatment at multiple acoustic intensity amplitudes, wherein a first amplitude is different from a second amplitude. The transducer module may be adapted to apply ultrasound therapy, whereby portions of the transducer module are adapted to transmit ultrasound therapy at a plurality of acoustic intensity phases, wherein a first phase is different from a second phase.

[0273] In several embodiments, an ultrasound treatment system for dithering simultaneous multi-focal therapy at multiple depths includes: a module including an ultrasound transducer, wherein the ultrasound transducer is adapted to simultaneously apply ultrasound treatment to tissue at multiple interval depths in the tissue, wherein the module modifies the intervals between the multiple interval depths via dithering of a first focal region and a second focal region so that the position of the beam focus is precisely moved at the multiple interval depths via frequency modulated dithering, wherein the module also includes an interface guide designed to be removably coupled to a cane to provide electronic communication and power between the module and the cane. In one embodiment, the ultrasound transducer is adapted to apply ultrasound treatment using amplitude modulation, whereby multiple portions of the ultrasound transducer are adapted to transmit ultrasound treatment at multiple acoustic intensity amplitudes, where the first amplitude is different from the second amplitude. The ultrasound transducer may be adapted to apply ultrasound treatment whereby multiple portions of the ultrasound transducer are adapted to transmit ultrasound treatment at multiple acoustic intensity phases, where the first phase is different from the second phase. In one embodiment, the ultrasound transducer includes a piezoelectric material, and the multiple portions of the ultrasound transducer are adapted to produce a plurality of corresponding piezoelectric material changes in response to an electric field applied to the ultrasound transducer. At least a portion of the ultrasonic transducer may be adapted to transmit the ultrasonic treatment at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic treatment transmitted by at least a portion of the ultrasonic transducer remains constant over time. In one embodiment, the ultrasonic treatment is at least one of a face lift, brow lift, chin lift, eye treatment, wrinkle reduction, shoulder enhancement, butt lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, cellulite treatment, abdominal relaxation treatment, vaginal rejuvenation, and acne treatment.

[0274] In several embodiments, a method of dithering a simultaneously focused ultrasound therapy beam at multiple depths includes providing an ultrasound probe including an ultrasound transducer including a single transducer element adapted to simultaneously apply ultrasound therapy to tissue at multiple spaced locations at multiple focal depths, and a control module coupled to the ultrasound probe for controlling the ultrasound transducer, and dithering the spacing between the spaced locations of a first focal region and a second focal region via frequency modulation to move the position of the ultrasound focus at the spaced locations. In one embodiment, the method includes imaging the first focal region with an ultrasound imaging element. The method may also include imaging the second focal region with an ultrasound imaging element. In one embodiment, the spacing between the first focal region and the second focal region is dithered within a range between 1-50%. The spacing between the first focal region and the second focal region is 1.5 mm with a fluctuation of 0.1 mm. In one embodiment, the frequency modulation is within a range between 1-50%. Ultrasound treatment is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, shoulder improvement, butt lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, vaginal rejuvenation, tummy tuck treatment, and acne treatment.

[0275] In several embodiments, a method of simultaneously dithering a focused ultrasound beam at multiple depths, the method comprising: providing an ultrasound probe including a single transducer element and a control module, wherein the single transducer element is adapted to apply ultrasound treatment to tissue at a focal region at a focal depth, wherein the control module is coupled to the ultrasound probe for controlling the single transducer element, and dithering the focal region via frequency modulation to change the size of the focal region at the tissue. In one embodiment, the relative position of the focal region is dithered within a range between 1-50%. A second focal region can be simultaneously emitted from the single transducer element. In one embodiment, the frequency modulation is within a range between 1-50%. The system is designed to operate non-invasively to treat tissue. In one embodiment, the method operates in a non-invasive manner to treat tissue.

[0276] In several embodiments, an ultrasound therapy system for delivering simultaneous multi-focal therapy at multiple depths with an electrostrictor comprises: a module comprising an ultrasound transducer, wherein the ultrasound transducer is adapted to simultaneously apply ultrasound therapy to tissue at multiple interval depths in the tissue through application of the electrostrictor, wherein the module modifies the intervals between the multiple interval depths via dithering of a first focal region and a second focal region so that the position of the beam focus is precisely moved at the multiple interval depths via frequency modulated dithering, wherein the module further comprises an interface guide designed to be removably coupled to a cane to provide electronic communication and power between the module and the cane. In one embodiment, the ultrasound transducer is adapted to apply ultrasound therapy using amplitude modulation, whereby multiple portions of the ultrasound transducer are adapted to emit ultrasound therapy at multiple acoustic intensity amplitudes, where the first amplitude is different from the second amplitude. The ultrasound transducer may be adapted to apply ultrasound therapy, whereby multiple portions of the ultrasound transducer are adapted to emit ultrasound therapy at multiple acoustic intensity phases, where the first phase is different from the second phase. In one embodiment, the ultrasound transducer comprises a piezoelectric material, and the multiple portions of the ultrasound transducer are adapted to produce multiple corresponding piezoelectric material changes in response to an electric field applied to the ultrasound transducer. At least a portion of the ultrasonic transducer may be adapted to transmit the ultrasonic treatment at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic treatment transmitted by at least a portion of the ultrasonic transducer remains constant over time. In one embodiment, the ultrasonic treatment is at least one of a face lift, brow lift, chin lift, eye treatment, wrinkle reduction, shoulder enhancement, butt lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, cellulite treatment, abdominal relaxation treatment, vaginal rejuvenation, and acne treatment.

[0277] In some embodiments, an ultrasound therapy system has one or more features described in the foregoing specification.

[0278] In several embodiments, a method of reducing imaging misalignment in a mobile ultrasound transducer has one or more of the features described in the foregoing specification.

[0279] In several embodiments, an ultrasound therapy system for generating multiple simultaneous focal points from an ultrasound transducer has one or more features described in the foregoing specification.

[0280] In several embodiments, an ultrasound therapy system for delivering multi-focal therapy has one or more features described in the foregoing specification.

[0281] In several embodiments, an ultrasound therapy module for forming multiple simultaneous focal areas from an ultrasound transducer in cosmetic treatment has one or more features described in the foregoing specification.

[0282] In several embodiments, a method for generating a simultaneous focused ultrasound therapy beam using multi-channel signal mixing has one or more features described in the foregoing specification.

[0283] In several embodiments, a method of generating simultaneous focused ultrasound beams has one or more of the features described in the preceding specification.

[0284] Some embodiments and examples described herein are examples and are not intended to limit the full scope of the compositions and methods of these inventions. Some embodiments, equivalent changes, modifications and variations of materials, compositions and methods can be made within the scope of the present invention with substantially similar results.

[0285] Although the invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the 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, the invention will cover all modifications, equivalents and alternatives that fall within the spirit and scope of the various embodiments described and the appended claims. Any method disclosed herein does not need to be performed in the order described. The methods disclosed herein include certain actions taken by the practitioner; however, they may also include any third-party instructions for these actions, either explicitly or implicitly. For example, an action such as "coupling the transducer module with the ultrasound probe" includes "instructing the coupling of the transducer module with the ultrasound probe". The ranges disclosed herein also include any and all overlaps, sub-ranges and combinations thereof. Language such as "at most", "at least", "greater than", "less than", "between..." includes the stated numbers. Numbers following terms such as "about" or "approximately" include the stated numbers. For example, "about 25 mm" includes "25 mm".

[0286] This specification also discloses the following items:

[0287] 1. A treatment system for simultaneously generating multiple focal points at different depths using an ultrasonic transducer, the system comprising:

[0288] An ultrasonic probe, comprising:

[0289] a first switch operable to control an ultrasound imaging function for providing ultrasound imaging;

[0290] a second switch operable to control an ultrasound therapy function for providing ultrasound therapy;

[0291] as well as

[0292] a movement mechanism configured to direct ultrasound treatment in at least one sequence of separate thermal cosmetic treatment areas; and

[0293] a transducer module configured to apply ultrasound therapy using at least one of the group consisting of amplitude modulation polarization and phase shifting,

[0294] wherein the transducer module is configured for ultrasonic imaging and ultrasonic therapy,

[0295] wherein the transducer module is configured to be coupled to the ultrasound probe,

[0296] wherein the transducer module comprises an ultrasound transducer configured to apply ultrasound therapy to tissue at a plurality of locations having at least two focal depths,

[0297] wherein the transducer module is configured to be operably coupled to at least one of the first switch, the second switch, and the moving mechanism; and

[0298] Control module,

[0299] Wherein, the control module includes a processor and a display, which are used to control the transducer module.

[0300] 2. A treatment system according to item 1, wherein the ultrasound treatment is a cosmetic treatment, wherein the plurality of positions are positioned in a substantially linear sequence within a cosmetic treatment area.

[0301] 3. A treatment system according to item 1, wherein the ultrasound treatment is a cosmetic treatment, wherein a first set of positions are positioned within a first treatment area and a second set of positions are positioned within a second treatment area, the first area being different from the second area.

[0302] 4. A treatment system according to item 3, wherein the first treatment area comprises a generally linear sequence of the first set of positions, and the second treatment area comprises a generally linear sequence of the second set of positions.

[0303] 5. A therapeutic system according to any one of items 1-4, wherein the transducer module is configured to apply ultrasound therapy using amplitude modulation, whereby multiple parts of the transducer module are configured to emit ultrasound therapy at multiple acoustic intensity amplitudes, wherein a first amplitude is different from a second amplitude.

[0304] 6. A therapeutic system according to any one of items 1-4, wherein the transducer module is configured to apply ultrasonic therapy using phase shifting, whereby multiple parts of the transducer module are configured to emit ultrasonic therapy at multiple acoustic intensity phases, wherein a first phase is different from a second phase.

[0305] 7. A therapeutic system according to any one of items 1 to 4, wherein the transducer module is configured to:

[0306] applying the ultrasound treatment using amplitude modulation, wherein portions of the transducer module are configured to transmit the ultrasound treatment at a plurality of acoustic intensity amplitudes, wherein a first amplitude is different than a second amplitude; and

[0307] Ultrasound therapy is applied using phase shifting, wherein portions of the transducer module are configured to transmit ultrasound therapy at a plurality of acoustic intensity phases, wherein a first phase is different from a second phase.

[0308] 8. A therapeutic system according to any one of items 1-4, wherein the multiple phases include discrete phase values.

[0309] 9. A therapeutic system according to any one of items 1-4, wherein the transducer module includes a piezoelectric material, and the multiple parts of the transducer module are configured to produce multiple corresponding piezoelectric material changes in response to an electric field applied to the transducer module.

[0310] 10. A therapeutic system according to item 9, wherein the multiple piezoelectric material changes include at least one of expansion of the material and contraction of the material.

[0311] 11. A therapeutic system according to any one of items 1-4, wherein at least a portion of the transducer module is configured to emit ultrasonic therapy at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic therapy emitted by the at least a portion of the transducer module varies over time.

[0312] 12. A treatment system according to any one of items 1 to 4, wherein the movement mechanism is configured to be programmed to provide variable spacing between a plurality of individual thermal cosmetic treatment areas.

[0313] 13. A treatment system according to any of items 1 to 4, wherein the sequence of individual thermocosmetic treatment areas has a treatment interval in the range of 1 mm to 25 mm.

[0314] 14. A therapeutic system according to any one of items 1-4, wherein the first switch and the second switch comprise user-operated buttons or keys.

[0315] 15. A therapeutic system according to any one of items 1-4, wherein at least one of the first switch and the second switch is activated by the control module.

[0316] 16. A therapeutic system according to any one of items 1-4, wherein the therapeutic function is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, cellulite treatment, shoulder treatment, vaginal rejuvenation and acne treatment.

[0317] 17. A therapeutic system according to any one of items 1-4, wherein the transducer module is configured to provide an acoustic power for ultrasonic therapy in a range between 10 W and 1000 W and a frequency of 1 MHz to 20 MHz to heat tissue by heat to induce coagulation.

[0318] 18. An ultrasound therapy system for dithering multiple simultaneous focal points from an ultrasound transducer at multiple depths, comprising:

[0319] an ultrasound probe including an ultrasound transducer having a single transducer element adapted to simultaneously apply ultrasound therapy to tissue at a plurality of spaced focal depths,

[0320] wherein the ultrasonic transducer is polarized with at least a first polarization configuration and a second polarization configuration,

[0321] a control module coupled to the ultrasound probe, for controlling the ultrasound transducer,

[0322] The control module modifies the intervals between the spaced positions via the dithering of the first focus area and the second focus area, so that the position of the beam focus is precisely moved at the spaced positions via the frequency modulated dithering.

[0323] 19. A treatment system according to item 18, wherein the plurality of positions are positioned in a linear sequence within the cosmetic treatment area, wherein the spaced positions are separated by intervals that are dithered via a frequency oscillation.

[0324] 20. The treatment system of item 18, wherein the first set of locations are positioned within a first cosmetic treatment area and the second set of locations are positioned within a second cosmetic treatment area, the first area being different from the second area.

[0325] 21. A therapeutic system according to item 18, wherein the ultrasonic transducer is suitable for applying ultrasonic treatment using amplitude modulation, whereby multiple portions of the ultrasonic transducer are suitable for emitting ultrasonic treatment at multiple acoustic intensity amplitudes, wherein a first amplitude is different from a second amplitude.

[0326] 22. A therapeutic system according to item 21, wherein at least a portion of the ultrasonic transducer is suitable for emitting ultrasonic therapy at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic therapy emitted by the at least a portion of the piezoelectric varies over time.

[0327] 23. A therapeutic system according to item 21, wherein the ultrasonic transducer includes a piezoelectric material, and the multiple portions of the ultrasonic transducer are suitable for generating multiple corresponding piezoelectric material changes in response to an electric field applied to the ultrasonic transducer.

[0328] 24. A therapeutic system according to item 23, wherein the multiple piezoelectric material changes include at least one of expansion of the piezoelectric material and contraction of the piezoelectric material.

[0329] 25. A therapeutic system according to any one of items 18-21, wherein the ultrasonic transducer is suitable for applying ultrasonic therapy via phase shifting, whereby multiple portions of the ultrasonic transducer are suitable for emitting ultrasonic therapy at multiple acoustic intensity phases, wherein a first phase is different from a second phase.

[0330] 26. A therapeutic system according to item 25, wherein the multiple phases include discrete phase values.

[0331] 27. A therapeutic system according to any one of items 18-21, wherein the ultrasound transducer is adapted to:

[0332] applying the ultrasound treatment using amplitude modulation, whereby portions of the ultrasound transducer are adapted to transmit the ultrasound treatment at a plurality of acoustic intensity amplitudes, wherein a first amplitude is different from a second amplitude; and

[0333] Ultrasound therapy is applied, whereby the plurality of portions of the ultrasound transducer are adapted to transmit the ultrasound therapy at a plurality of acoustic intensity phases, wherein a first phase is different from a second phase.

[0334] 28. A treatment system according to any one of items 18-21, wherein the ultrasound treatment is at least one of the following: face lift, brow lift, chin lift, eye treatment, wrinkle reduction, shoulder improvement, buttocks lift, scar reduction, burn treatment, skin tightening, blood vessel reduction, sweat gland treatment, sun spot removal, fat treatment, abdominal relaxation treatment and cellulite treatment.

[0335] 29. A treatment system according to any one of items 18-21, wherein the ultrasound probe comprises a movement mechanism adapted to guide the ultrasound treatment in at least a pair of simultaneous sequences of separate thermal cosmetic treatment areas.

[0336] 30. A treatment system according to any one of items 18-21, wherein the ultrasound probe is configured for ultrasound imaging and ultrasound treatment.

[0337] 31. A therapeutic system according to any one of items 18-21, wherein the ultrasound probe includes a transducer module suitable for applying ultrasound therapy.

[0338] 32. A method of simultaneously dithering a focused ultrasound beam at multiple depths, the method comprising:

[0339] An ultrasound probe including a single transducer element and a control module are provided,

[0340] wherein the single transducer element is adapted to apply ultrasound therapy to tissue at a focal region at a focal depth,

[0341] wherein the control module is coupled to the ultrasound probe for controlling the single transducer element, and

[0342] The focal region is dithered via frequency modulation to vary the size of the focal region at the tissue.

[0343] 33. A method according to item 32, wherein the relative position of the focus area is jittered within a range between 1-50%.

[0344] 34. The method of clause 32, wherein a second focal region is emitted simultaneously from the single transducer element.

[0345] 35. The method according to item 32, further comprising imaging the focal area using the ultrasound imaging element.

[0346] 36. The method according to item 32, wherein the frequency modulation is in the range between 1% and 50%.

[0347] 37. A therapeutic system according to item 32, wherein the system is designed to work non-invasively to treat tissue.

[0348] 38. A method according to any one of items 32 to 36, wherein the method acts in a non-invasive manner to treat tissue.

[0349] 39. An ultrasound treatment system for delivering simultaneous multi-focal therapy at multiple depths using an electrostrictor, comprising:

[0350] A module comprising an ultrasonic transducer,

[0351] wherein the ultrasonic transducer is adapted to simultaneously apply ultrasonic treatment to tissue at multiple spaced depths in the tissue through the use of an electrostrictor,

[0352] wherein the module modifies the intervals between the plurality of interval depths via dithering of the first focal region and the second focal region so as to precisely move the position of the beam focus at the plurality of interval depths via the frequency modulated dithering,

[0353] Wherein, the module further comprises an interface guide designed to be removably coupled to a walking stick to provide electronic communication and power between the module and the walking stick.

[0354] 40. A therapeutic system according to item 39, wherein the ultrasonic transducer is suitable for applying ultrasonic treatment using amplitude modulation, whereby multiple portions of the ultrasonic transducer are suitable for emitting ultrasonic treatment at multiple acoustic intensity amplitudes, wherein a first amplitude is different from a second amplitude.

[0355] 41. A therapeutic system according to item 39, wherein the ultrasonic transducer is suitable for applying ultrasonic treatment, whereby multiple portions of the ultrasonic transducer are suitable for emitting ultrasonic treatment at multiple acoustic intensity phases, wherein a first phase is different from a second phase.

[0356] 42. A therapeutic system according to item 39, wherein the ultrasonic transducer includes a piezoelectric material, and the multiple portions of the ultrasonic transducer are suitable for generating multiple corresponding piezoelectric material changes in response to an electric field applied to the ultrasonic transducer.

[0357] 43. A therapeutic system according to item 39, wherein at least a portion of the ultrasonic transducer is suitable for emitting ultrasonic therapy at two or more acoustic intensity amplitudes, and wherein the amplitude of the ultrasonic therapy emitted by at least a portion of the ultrasonic transducer remains constant over time.

[0358] 44. A treatment system according to any one of items 39 to 43, wherein the ultrasound treatment is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, shoulder improvement, buttocks lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, treating sweat glands, treating hyperhidrosis, sun spot removal, fat treatment, cellulite treatment, abdominal relaxation treatment, vaginal rejuvenation and acne treatment.

[0359] 45. An ultrasound therapy system having one or more of the features described in the preceding description.

[0360] 46. ​​A method of reducing imaging misalignment in a mobile ultrasound transducer having one or more of the features described in the preceding description.

[0361] 47. An ultrasound therapy system for generating multiple simultaneous focal points from an ultrasound transducer having one or more of the features described in the preceding specification.

[0362] 48. An ultrasound therapy system for delivering multi-focal therapy having one or more of the features described in the preceding specification.

[0363] 49. An ultrasound therapy module for forming multiple simultaneous focal zones from an ultrasound transducer in cosmetic treatment, having one or more of the features described in the preceding description.

[0364] 50. A method for generating simultaneous focused ultrasound therapy beams using multi-channel signal mixing, having one or more of the features described in the preceding description.

Claims

1. A treatment system for simultaneously generating multiple focal points at different depths using an ultrasonic transducer, characterized in that: The system comprises: An ultrasonic probe, comprising: a first switch operable to control an ultrasound imaging function for providing ultrasound imaging; a second switch operable to control an ultrasound therapy function for providing ultrasound therapy; and a movement mechanism configured to direct ultrasound treatment in at least one sequence of separate thermal cosmetic treatment areas; and a transducer module configured to apply ultrasound therapy using at least one of the group consisting of amplitude modulation polarization and phase shifting, wherein the transducer module is configured for ultrasonic imaging and ultrasonic therapy, wherein the transducer module is configured to be coupled to the ultrasound probe, wherein the transducer module comprises an ultrasound transducer configured to apply ultrasound therapy to tissue at a plurality of locations having at least two focal depths, wherein the transducer module is configured to be operably coupled to at least one of the first switch, the second switch, and the moving mechanism; and Control module, Wherein, the control module includes a processor and a display, which are used to control the transducer module.

2. The treatment system according to claim 1, characterized in that The ultrasound treatment is a cosmetic treatment, wherein the plurality of locations are positioned in a substantially linear sequence within a cosmetic treatment area.

3. The treatment system according to claim 1, characterized in that The ultrasound treatment is a cosmetic treatment wherein a first set of locations are positioned within a first treatment zone and a second set of locations are positioned within a second treatment zone, the first zone being different from the second zone.

4. The treatment system according to claim 3, characterized in that The first treatment area comprises a generally linear sequence of the first set of locations, and the second treatment area comprises a generally linear sequence of the second set of locations.

5. The treatment system according to any one of claims 1 to 4, characterized in that: The transducer module is configured to apply ultrasound therapy using amplitude modulation, whereby portions of the transducer module are configured to transmit ultrasound therapy at a plurality of acoustic intensity amplitudes, wherein a first amplitude is different than a second amplitude.

6. The treatment system according to any one of claims 1 to 4, characterized in that: The transducer module is configured to apply ultrasound therapy using phase shifting, whereby portions of the transducer module are configured to transmit ultrasound therapy at a plurality of acoustic intensity phases, wherein a first phase is different from a second phase.

7. The treatment system according to any one of claims 1 to 4, characterized in that: The transducer module is configured as follows: applying the ultrasound treatment using amplitude modulation, wherein portions of the transducer module are configured to transmit the ultrasound treatment at a plurality of acoustic intensity amplitudes, wherein a first amplitude is different than a second amplitude; and Ultrasound therapy is applied using phase shifting, wherein portions of the transducer module are configured to transmit ultrasound therapy at a plurality of acoustic intensity phases, wherein a first phase is different from a second phase.

8. The treatment system according to any one of claims 1 to 4, characterized in that: The plurality of phases comprises discrete phase values.

9. The treatment system according to any one of claims 1 to 4, characterized in that: The transducer module includes a piezoelectric material, and the plurality of portions of the transducer module are configured to produce a plurality of corresponding piezoelectric material changes in response to an electric field applied to the transducer module.

10. The treatment system according to claim 9, characterized in that The plurality of piezoelectric material changes include at least one of expansion of the material and contraction of the material.

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