Ultrasound treatment system, ultrasound system

Abstract

Embodiments relate to dermatological cosmetic treatments and / or imaging systems and methods adapted to vary the placement and location of multiple cosmetic treatment zones within tissue with an ultrasound beam from a transducer, and / or to vary simultaneous multi-focal treatment at multiple depths, and / or to vary dithering of an ultrasound beam from a transducer to vary the placement and location of multiple cosmetic treatment zones within tissue. The system may include a hand wand, a detachable transducer module, and a control module. In some embodiments, the cosmetic treatment system may be used in a variety of cosmetic procedures. [Selected Figure] Figure 1A

Description

Technical Field

[0001] Incorporation by Reference U.S. Provisional Patent Application No. 62 / 622,394, filed on January 26, 2018, is hereby incorporated by reference in its entirety for all purposes.

[0002] Some embodiments of the present invention relate to energy-based non-invasive procedures for obtaining aesthetic and / or cosmetic enhancement effects on the face, head, neck, and / or body of a human, with respect to the skin and / or tissues near the skin, by delivering energy simultaneously or substantially simultaneously to multiple dimensions (e.g., depth, height, width, spacing, orientation, arrangement) of tissues below the skin surface.

Background Art

[0003] Some cosmetic procedures include invasive procedures that may require invasive surgery. Patients not only have to endure a recovery period of several weeks, but often also have to undergo risky anesthesia procedures. Although non-invasive energy-based treatment devices and methods are available, they may have various drawbacks with respect to efficiency and effectiveness.

Summary of the Invention

[0004] In some embodiments, when performing various treatment procedures and / or imaging procedures, the ultrasonic treatment beam is divided into two, three, four, or more simultaneous focus zones, so as to achieve a visible and effective aesthetic result through a thermal pathway, a system and method for successfully achieving an aesthetic effect using the precise ultrasonic wave for the purpose are provided. In various embodiments, the ultrasonic system is configured to perform local mechanical movement within tissues and cells to generate local heating for either tissue coagulation or mechanical cell membrane disruption intended for non-invasive aesthetic use, so as to focus the ultrasonic wave. In various embodiments, the ultrasonic system is configured to lift the eyebrows (e.g., eyebrow lift). In various embodiments, the ultrasonic system is configured to lift loose tissues, slack tissues, or flabby tissues, such as the pituitary gland (under the jaw) and neck tissues. In various embodiments, the ultrasonic system is configured to improve the décolletage line and wrinkles. In various embodiments, the ultrasonic system is configured to reduce fat. In various embodiments, the ultrasonic system is configured to reduce the appearance of cellulite. In some embodiments, the system is provided as one that performs both fat reduction and subsequent treatment of skin laxity resulting from fat reduction.

[0005] Although various embodiments for aesthetic treatment are envisioned herein, the systems and procedures described herein are also used for non-aesthetic applications in some embodiments.

[0006] In various embodiments, the ultrasonic system is configured to be imageable to visualize tissues (e.g., the dermis and subcutaneous layers of the tissue) to ensure proper coupling of the transducer to the skin. In various embodiments, the ultrasonic system is configured to be imageable to visualize tissues (e.g., the dermis and subcutaneous layers of the tissue) to confirm the appropriate depth of treatment, such as avoiding specific tissues (e.g., bone).

[0007] In various embodiments, treating tissues such as skin tissue with multiple beams provides one or more advantages, including, for example, reduced treatment time, generation of unique heating patterns, utilization of greater power through the use of multiple channels, the option to treat the skin at two or more depths with the same or different power levels (e.g., a thermal coagulation point within the superficial fascia ("SMAS") and other focal points with blurred energy at the skin surface, or other combinations), optional simultaneous treatment at different depths (e.g., thermal coagulation points at depths of 1.5 mm, 3 mm, and / or 4.5 mm below the skin surface, simultaneously or in overlapping timeframes), and / or treatment with one, two, or more simultaneous linear or linear focal points at different depths below the skin surface or at different depths spaced apart from each other. In some embodiments, simultaneous multi-focal treatment utilizes dithering.

[0008] According to one embodiment, an ultrasonic treatment system generates two or more simultaneous treatment points and / or focal zones below the skin surface for cosmetic treatment, and the treatment points are enlarged by dithering the ultrasonic beam. In one embodiment, the focal zone is a point. In one embodiment, the focal zone is a line. In one embodiment, the focal zone is a plane. In one embodiment, the focal zone is a three-dimensional volume or shape. Dithering the focal point of the ultrasonic beam enlarges the treatment area by changing the frequency of the ultrasonic treatment beam, and therefore changing the focal point of the ultrasonic treatment beam, by mechanically and / or electronically scattering the position of the focal point, as if painting with an airbrush, by shaking, blurring or scattering the focal point or focal zone (e.g., focal point, focal line, focal plane, or focal volume). In some embodiments, dithering increases the effect by forming larger treatment points and / or larger focal zones. In some embodiments, dithering reduces pain by spreading the temperature of the high-temperature spot to a larger volume of tissue, thereby allowing for a reduction in potential radiation dose. In some embodiments, mechanical dithering is a method for diffusing acoustic energy from an ultrasonic beam, so that tissues away from the focal point are less dependent on heat conduction. In one embodiment of mechanical dithering, a therapeutic transducer is driven locally around the intended center of the thermal coagulation point (TCP). The movement of the acoustic beam can be left-right, up-down, and / or angular. In one embodiment of mechanical dithering, the movement of the drive mechanism is fast enough to generate a flatter temperature profile around the intended TCP, which allows for a reduction in the total amount of acoustic energy with respect to the same affected tissue volume, or a greater impact on the tissue volume with the same total amount of acoustic energy, or any combination thereof.

[0009] According to various embodiments, frequency modulation alters the position of the focal point and / or the spacing between focal zones so that electronic dithering of the beam via frequency modulation precisely alters and / or shifts the position of the beam's focal point. For example, in one embodiment, a spacing of 1.5 mm can be dithered by ±0.1 mm using a small frequency swing. In various embodiments, any one or more spacings of 0.5 mm, 0.75 mm, 1.0 mm, 1.2 mm, 1.5 mm, and 2.0 mm can be dithered by ±0.01 mm, ±0.05 mm, ±0.1 mm, ±0.12 mm, ±0.15 mm, ±0.20 mm, ±0.25 mm, and ±0.30 mm using frequency swing. In various embodiments, the frequency is modulated by a range of 1% to 200% (for example, 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 100%, 120%, 150%, 180%, 200%, and any range within this range).

[0010] Some embodiments relate to devices, systems, and methods for providing one or more (e.g., multiple or numerous) focal zones and / or ultrasound treatment points when rapidly, safely, efficiently, and effectively performing 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 conversion element into two, three, four, or more focal zones. In some embodiments, multiple ultrasound beams are electronically manipulated by frequency modulation. In some embodiments, dithering (e.g., electronic dithering) of multiple and / or divided ultrasound beam apertures using frequency modulation provides treatment zones or treatment points at multiple locations. In some embodiments, dithering relates to intentional movement with respect to the position / arrangement of the energy beam focal points. For example, in one embodiment, dithering includes shaking, moving, vibrating, and changing the arrangement and / or position of a single focal zone and / or the relative spacing between two or more focal zones. In various embodiments, the relative position of the focal zones is dithered by 1% to 50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, and any range within this, e.g., the ratio of average position by a specific ratio). In various embodiments, the spacing between focal zones is dithered by 1% to 50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, and any range within this). In some embodiments, depending on the system design, dithering can be performed by mechanical means, electronic means, or a combination of mechanical and electronic means. In one embodiment of mechanical dithering, the ultrasound beam is driven locally around the intended TCP center by the mechanical translational movement or tilting of the therapeutic transducer or the patient, or any combination thereof. Mechanical translational movement and / or tilting allow for the propagation of acoustic energy so that the thermal conductivity limits of the tissue are overcome.This generates a flatter temperature profile within the tissue, thereby reducing the total acoustic energy required to produce the same tissue volume compared to a stationary ultrasound therapy device, or increasing the tissue volume that receives the same effect with the same total acoustic energy. Various embodiments of electronic dithering use frequency-based, phase-based, amplitude-modulation-based, or time-based techniques, combined with a custom-defined transducer, to move the ultrasound beam within the tissue without any mechanical movement. In one embodiment, the electronic movement of the ultrasound beam occurs significantly faster than mechanical movement, overcoming the limitations of the tissue's thermal conductivity. In various embodiments, the relative focal zone positioning ratio 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 zone positions 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 opening interval ratio of the untreated tissue is provided at a second number of the ratio. For example, in one embodiment, the dithering interval is, for example, 1 mm, the dithering distance is 0.1 mm, and therefore the ratio is 1:10. In various embodiments, the ratio of the spacing between 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 spacing between simultaneous focal zones is dithered. In some embodiments, the treatment point and / or treatment zone are formed simultaneously within the tissue. In various embodiments, the dithering for performing various treatment and / or imaging procedures is modulated and / or polyphased, along with controlled changes in frequency.Some embodiments relate to dividing an ultrasound therapeutic beam into two, three, four, or more focal zones when performing various treatment procedures and / or imaging procedures, for example, in conjunction with dithering, polarization, phase adjustment, and modulation techniques.

[0011] In some embodiments disclosed herein, a non-invasive ultrasound system is adapted to be used to achieve one or more of the following beneficial aesthetic and / or cosmetic improvement effects: That is, facelifts, eyebrow lifts, jaw lifts, eye treatments (e.g., cheek pouches, infraorbital laxity treatments), wrinkle reduction, fat reduction (e.g., fat and / or cellulite treatments), cellulite treatment (may be referred to as glenoid lipodystrophy) (e.g., dimple-type or non-dimple-type female glenoid lipodystrophy), décolletage improvement (e.g., upper chest), buttock lifts (e.g., buttock tightening), skin tightening (e.g., treatments for laxity that cause tightening in the face or body, such as the face, neck, chest, arms, thighs, abdomen, buttocks, etc.), scar reduction (e.g., reduction of breast fibrosis), burn treatment, tattoo removal, vein removal, vein reduction, sweat gland treatments, hyperhidrosis treatment, sunspot removal, acne treatment, and acne reduction. Some embodiments of the present invention are particularly advantageous for including one, some, or all of the following advantages. In other words, (i) faster treatment time, (ii) less pain during treatment, (iii) less pain after treatment, (iv) shorter recovery time, (v) more efficient treatment, (vi) greater customer satisfaction, (vii) less energy required to complete the treatment, and / or (viii) a larger treatment area based on the dithered focal area. Various advantages of embodiments of a simultaneous multi-depth treatment device configured to generate multiple TCPs at various depths include generating TCPs simultaneously at multiple depths. In one embodiment, the advantage is the elimination of the need for multiple transducers, thereby reducing the need for the operator to change transducers. In one embodiment, the advantage is faster treatment time. In one embodiment, the advantage is delivering the same number of lines with fewer button presses. In one embodiment, the advantage is modulating the distance between TCPs delivered simultaneously. In one embodiment, the advantage is maintaining the pitch spacing of TCPs at each depth along the mechanical movement line.In one embodiment, the advantage is to avoid pulse stacking at multiple depths. In one embodiment, the advantage is the ability to generate larger zones of coagulation and apoptosis. In one embodiment, the advantage is to enable the ability to deliver microcoagulation lines along three dimensions. In one embodiment, the advantage of using an electrostrictive element is to generate three or more lines by a single transducer placed on the patient's body. In one embodiment, the advantage of using an electrostrictive element is to modulate the distance between simultaneously delivered TCPs. In one embodiment, the advantage is to modulate the ability to mute spatial high-frequency harmonics from the simultaneous therapeutic modulation pattern. In one embodiment, the advantage of using an electrostrictive element is to provide the possibility of adding nulls to the modulation pattern. In one embodiment, the advantage of using an electrostrictive element is to effectively modulate the distance between simultaneously delivered TCPs while performing electronic steering and focusing control on opposite faces. This can take the form of stripes, annular rings, and segments formed by electrostrictive elements, or stripes that are orthogonal to each other (or at any angle to each other, such as 0° to 180° (5°, 10°, 15°, 20°, 30°, 45°, 60°, 90°, or more)). In various embodiments, the transducer can be segmented. In various embodiments, a flat transducer can be focused using a lens. In various embodiments, the transducer can be spherically focused to one or more points. In various embodiments, the transducer can be cylindrically focused to one or more lines.

[0012] According to various embodiments, cosmetic ultrasound treatment systems and / or methods can non-invasively generate one or more dithered cosmetic treatment zones and / or thermal coagulation points, where ultrasound is focused on one or more locations within a treatment area of ​​tissue below the skin surface and driven via frequency variation (e.g., via frequency modulation). Some systems and methods provide cosmetic treatment at different locations within tissue, such as different depths, different heights, different widths, and / or different positions. In one embodiment, the method and system includes multiple depth / height / width transducer systems configured to provide ultrasound treatment to one or more regions of interest, such as between at least one depth, a surface region of interest, and / or a subcutaneous region of interest. In one embodiment, the method and system includes transducer systems configured to provide ultrasound treatment to one or more regions of interest, such as between at least two points at different locations within the region of interest within tissue (e.g., fixed or variable depth, height, width, and / or orientation, etc.). In some embodiments, the beam can be split to focus to two, three, four, or more foci (e.g., multiple foci, multifocal) for cosmetic treatment zones and / or imaging of regions of interest within tissue. The position and / or dithering of the foci can be axial, transverse, or otherwise positioned within the tissue. In some embodiments, spatial control can be achieved by the position and / or dithering of the foci, and / or by changing the distance from the transducer to the reflective surface, and / or by changing the angle of energy focused or blurred with respect to the region of interest, and / or by controlling changes in the frequency, drive amplitude, and timing of the transducer. In some embodiments, the position and / or dithering with respect to multiple treatment zones or foci is achieved by polarization, phase polarization, two-phase polarization, and / or multi-phase polarization.In some embodiments, phase adjustments, such as electrical phase adjustment in one embodiment, are performed on the locations of multiple treatment zones or focal points. As a result, changes in position, number, shape, size, and / or volume, as well as changes in thermal conditions, with respect to the treatment zones or damage within the region of interest can be dynamically controlled over time.

[0013] According to various embodiments, a cosmetic ultrasound treatment system and / or method can generate multiple cosmetic treatment zones using one or more of frequency modulation, phase modulation, polarization, nonlinear acoustics, and / or Fourier transforms, thereby generating any spatial periodic pattern having one or more ultrasonic portions. In one embodiment, the system uses polarization at the ceramic level to deliver one or more treatment zones simultaneously or sequentially. In one embodiment, the polarization pattern is a function of focal depth and frequency, and also involves the use of odd or even functions. In one embodiment, a polarization pattern, which may be a combination of odd or even functions, is applied based on focal depth and / or frequency. In one embodiment, any spatial periodic pattern can be generated by using the process in two or more dimensions. In one embodiment, the ultrasonic beam is split axially and transversely, thereby significantly reducing treatment time through the use of nonlinear acoustics and Fourier transforms. In one embodiment, multiple treatment zones can be positioned within the tissue either sequentially or simultaneously by using modulation from the system and amplitude modulation from the ceramic or transducer.

[0014] In one embodiment, the aesthetic imaging and treatment system includes an ultrasound probe, which includes an ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations in the depth of field by electronic dithering of multiple energy beam apertures by frequency modulation. In one embodiment, the system includes a control module coupled to the ultrasound probe for controlling the ultrasound transducer.

[0015] In one embodiment, the system includes dithering configured to provide variable spacing between multiple individual cosmetic treatment zones. In one embodiment, a sequence of multiple individual cosmetic treatment zones has treatment intervals ranging from approximately 0.01 mm to approximately 25 mm (e.g., 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 5 mm, 10 mm, 20 mm, and any value within this range), with dithering changes of 1% to 50% (e.g., 1%, 5%, 10%, 15%, 20%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, and any range within this range). In one embodiment, a sequence consisting of multiple individual cosmetic treatment zones has treatment intervals within the range of approximately 0.01 mm to approximately 100 mm (for example, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 5 mm, 10 mm, 20 mm, 25 mm, 40 mm, 45 mm, 50 mm, and any value within this range), with dithering changes at intervals of 1% to 50% (for example, 1%, 5%, 10%, 15%, 20%, 25 mm, 3 mm, 35 mm, 40 mm, 45 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm, 100 mm, and any value within this range).

[0016] In one embodiment, the system further includes a drive mechanism configured to be programmable to provide a fixed or variable interval between a plurality of individual cosmetic treatment zones. In one embodiment, a sequence of a plurality of individual cosmetic treatment zones has treatment intervals within a range of approximately 0.01 mm to approximately 50 mm (e.g., 0.1 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 15 mm, 19 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 49 mm, or any range or value within this range). In one embodiment, a sequence consisting of multiple individual cosmetic treatment zones has treatment intervals within a range of approximately 0.01 mm to approximately 100 mm (e.g., 0.1 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 50 mm, 100 mm, or any range or value within this range). In one embodiment, the treatment zones are provided along a distance of approximately 25 mm. In one embodiment, the treatment zones are provided along a distance of approximately 50 mm. In various embodiments, the treatment zones are 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 value or range within this range). In various embodiments, the treatment zones are provided along a straight distance and / or along a curved distance.

[0017] For example, in some non-limiting embodiments, the transducer can be configured to adapt to tissue depths of 0.5 mm, 1.0 mm, 1.5 mm, 2 mm, 3 mm, 4.5 mm, 6 mm, less than 3 mm, 0.5 mm to 5 mm, 1.5 mm to 4.5 mm, greater than 4.5 mm, greater than 6 mm, and within the ranges of 0.1 mm to 3 mm, 0.1 mm to 4.5 mm, 0.1 mm to 25 mm, 0.1 mm to 100 mm, as well as any depth within this range (e.g., 6 mm, 10 mm, 13 mm, 15 mm, 17 mm). In some embodiments, the tissue is treated at a depth below the skin surface, and the skin surface is not damaged. Instead, the treatment effect obtained at a depth below the skin surface results in a desirable cosmetic appearance of the skin surface. In other embodiments, the skin surface is treated by ultrasound (e.g., at a depth of less than 0.5 mm).

[0018] One advantage of the drive mechanism is that it can provide more efficient, accurate, and precise use of the ultrasonic transducer for imaging and / or therapeutic purposes. One advantage of this type of drive mechanism is that it is superior to conventional fixed arrays consisting of multiple transducers fixed in space within a housing, where the fixed arrays are spaced apart by a fixed distance. In one embodiment, the transducer module is configured to provide an acoustic output for ultrasonic therapy in the range of about 1W to about 100W, or 100W to 1000W (e.g., 3W to 30W, 7W to 30W, 21W to 33W, 200W, 500W, 750W, 900W), or higher, and a frequency of about 1MHz to about 20MHz, in order to thermally heat tissue and induce coagulation. In one embodiment, the transducer module is configured to provide an acoustic output for ultrasonic therapy in the range of approximately 1W to approximately 500W (e.g., 3W to 30W, 7W to 30W, 21W to 33W, 100W, 220W, or more) in peak or average energy, and a frequency of approximately 1MHz to approximately 20MHz, in order to thermally heat tissue and induce coagulation. In some embodiments, instantaneous energy is delivered. In some embodiments, average energy is delivered. In one embodiment, the acoustic output can range from 1W to approximately 100W in the frequency range of approximately 1MHz to approximately 20MHz (e.g., 1MHz, 3MHz, 4MHz, 4.5MHz, 7MHz, 10MHz, 2MHz to 12MHz, 15MHz, 18MHz, 2MHz to 18MHz), or it can range from approximately 10W to approximately 50W in the frequency range of approximately 3MHz to approximately 8MHz (e.g., 3MHz, 4MHz, 4.5MHz, 7MHz). In one embodiment, the acoustic output can be in the range of 1W to approximately 500W in a frequency range of approximately 1MHz to approximately 12MHz (for example, 1MHz, 4MHz, 7MHz, 10MHz, 2MHz to 12MHz), or in the range of approximately 10W to approximately 220W in a frequency range of approximately 3MHz to approximately 8MHz, or 3MHz to 10MHz. In one embodiment, the acoustic output and frequency are approximately 40W at approximately 4.3MHz and approximately 30W at approximately 7.5MHz.The acoustic energy generated by this acoustic output can be from about 0.01 joules ("J") to about 10 J, or from about 2 J to about 5 J. The acoustic energy generated by this acoustic output can be from about 0.01 J to about 60,000 J (e.g., via bulk heating, to body shape, submandibular fat, abdomen and / or flanks, arms, inner thighs, outer thighs, buttocks, abdominal laxity, cellulite), about 10 J, or from about 2 J to about 5 J. In one embodiment, the acoustic energy is in the range of less than about 3 J. In various embodiments, the treatment output is 1 kW / cm.

[0020] , 2 , , , 2 , , 2 ,

[0019] ~100 kW / cm 2 , 15 kW / cm 2 ~75 kW / cm 2 , 1 kW / cm 2 ~5 kW / cm 2 , 500 W / cm 2 ~10 kW / cm 2 , 3 kW / cm 2 ~10 kW / cm 2 , 15 kW / cm 2 ~50 kW / cm 2 , 20 kW / cm 2 ~40 kW / cm 2 , and / or 15 kW / cm 2 ~35 kW / cm 2 , and is.

[0019] In various embodiments, an ultrasonic treatment system for disturbing a plurality of simultaneous foci from one ultrasonic transducer includes an ultrasonic probe and a control module coupled to the ultrasonic probe for controlling the ultrasonic transducer. The ultrasonic probe includes an ultrasonic transducer having a single transducer element adapted to simultaneously apply ultrasonic treatment to tissue at a plurality of spaced-apart positions at the depth of focus. The ultrasonic transducer is polarized by at least a first polarization configuration and a second polarization configuration. The control module changes the spacing between a plurality of spaced-apart positions via disturbing the first focus zone and the second focus zone, thereby accurately moving the position of the beam focus at a plurality of spaced-apart positions by disturbing via frequency modulation.

[0020] In one embodiment, multiple locations are arranged in a linear sequence within a cosmetic treatment zone, and the spaced-apart locations are separated by a dithered interval via frequency swing. In one embodiment, a first set of multiple locations is located within a first cosmetic treatment zone, and a second set of multiple locations is located within a second cosmetic treatment zone, the first zone being distinct from the second zone. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, the first amplitude being distinct from the second amplitude. In one embodiment, at least a portion of the ultrasonic transducer is adapted to emit ultrasonic therapy at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasonic therapy emitted by at least a portion of the piezoelectric material changes over time. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and multiple parts of the ultrasonic transducer are adapted to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the plurality of changes in the piezoelectric material include at least one of expansion of the piezoelectric material and contraction of the piezoelectric material. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy via phase shift, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, 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 is adapted to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude, and further adapted to apply ultrasonic therapy, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase. Skin tightening by reducing skin laxity is performed in some embodiments to treat subjects with excess or loose skin after such weight loss, whether the weight loss occurred spontaneously or surgically induced.

[0021] In various embodiments, an ultrasound treatment system for use in cosmetic procedures for dithering multiple simultaneous focal points from a single ultrasound transducer includes an ultrasound probe comprising: a control module adapted to change the distance between a first focal zone and a second focal zone via dithering; a switch for operably controlling the ultrasound treatment function to provide ultrasound treatment; and a drive mechanism adapted to guide ultrasound treatment to form at least one pair of simultaneous sequences consisting of multiple individual thermal cosmetic treatment zones; and a transducer module adapted to apply ultrasound treatment. The ultrasound module is adapted to perform both ultrasound imaging and ultrasound treatment. The ultrasound module is adapted to be coupled to the ultrasound probe. The ultrasound module includes an ultrasound transducer adapted to apply ultrasound treatment to tissue at multiple locations at the depth of focus. The ultrasound module is adapted to be operably coupled to at least one of the switch and the drive mechanism. The control module includes a processor and a display for controlling the transducer module.

[0022] In one embodiment, the transducer module is adapted to apply ultrasound therapy using amplitude modulation, in which case multiple parts of the transducer module are adapted to emit ultrasound therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. In another embodiment, the transducer module is adapted to apply ultrasound therapy, in which case multiple parts of the transducer module are adapted to emit ultrasound therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase.

[0023] In various embodiments, an ultrasonic treatment system for dithering multi-focus treatment includes a module containing an ultrasonic transducer. The ultrasonic transducer is adapted to simultaneously apply ultrasonic treatment to tissue at spaced-apart locations within the tissue, and the module changes the spacing between multiple spaced-apart locations via dithering between a first focal zone and a second focal zone, thereby allowing precise movement of the beam focus at multiple spaced-apart locations through frequency-modulated dithering, and the module further includes an interface guide designed to be detachably coupled to a handwand so as to provide electronic communication and power between the module and the handwand.

[0024] In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and multiple parts of the ultrasonic transducer are adapted to generate a plurality of corresponding changes in the piezoelectric material 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 emit ultrasonic therapy at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasonic therapy emitted by at least a portion of the ultrasonic transducer remains constant over time. In one embodiment, ultrasound treatment is at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment (e.g., cheek pouch, infraorbital laxity treatment), wrinkle reduction, décolletage improvement, buttock lift, scar reduction, burn treatment, tattoo removal, skin tightening (e.g., abdominal laxity treatment, or skin tightening in other areas of the body and face, such as the abdomen, buttocks, thighs, arms, and other areas, during or after weight loss, any excess skin or tissue), vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, vaginal rejuvenation, and acne treatment.

[0025] In various embodiments, a method for dithering multiple simultaneously focused ultrasound treatment beams includes preparing an ultrasound probe including an ultrasound transducer having a single converter element adapted to simultaneously apply ultrasound treatment to tissue at multiple spaced-apart positions at the depth of focus, and a control module coupled to the ultrasound probe for controlling the ultrasound transducer, and moving the position of the ultrasound focus at multiple spaced-apart positions by dithering the spacing between multiple spaced-apart positions in the first and second focal zones via frequency modulation.

[0026] In one embodiment, the method includes imaging a first focal zone with an ultrasonic image sensor. In another embodiment, the method includes imaging a second focal zone with an ultrasonic image sensor. In one embodiment, the spacing between the first and second focal zones is dithered in the range of 1% to 50%. In another embodiment, the spacing between the first and second focal zones is 1.5 mm, in increments of 0.1 mm. In another embodiment, the frequency modulation is in the range of 1% to 50%.

[0027] In various embodiments, a method for dithering a focused ultrasound beam includes preparing an ultrasound probe comprising a single transformer and a control module, wherein the single transformer is adapted to apply ultrasound therapy to tissue in a focal zone at the depth of focus, and the control module is coupled to the ultrasound probe to control the single transformer, and the size of the focal zone at the tissue is changed by dithering the focal zone via frequency modulation.

[0028] In one embodiment, the relative position of the focal zone is dithered in the range of 1% to 50%. In one embodiment, the second focal zone is emitted simultaneously from a single conversion element. In one embodiment, this method includes imaging the focal zone with an ultrasonic imaging element. In one embodiment, the frequency modulation is in the range of 1% to 50%.

[0029] In various embodiments, an ultrasonic treatment system for generating multiple focal points at different depths with a single ultrasonic transducer includes an ultrasonic probe with an ultrasonic transducer configured to apply ultrasonic treatment to tissue at multiple locations having at least two focal depths by at least one of the group consisting of amplitude modulation polarization and phase shift; a drive mechanism configured to be programmable to provide spacing between multiple individual cosmetic treatment zones, the sequence of multiple individual cosmetic treatment zones having treatment intervals in the range of 1 mm to 50 mm; and a control module coupled to the ultrasonic probe for controlling the ultrasonic transducer, wherein the ultrasonic transducer is configured to provide an acoustic output for ultrasonic treatment in the range of 10 W to 1000 W and a frequency of 1 MHz to 20 MHz, so as to be able to thermally heat the tissue and induce coagulation. The multiple locations are arranged in a substantially linear sequence within the cosmetic treatment zones, and the ultrasonic transducer includes a single ultrasonic transducer element. In one embodiment, a first set of positions is located within a first cosmetic treatment zone, and a second set of positions is located within a second cosmetic treatment zone, wherein the first zone is distinct from the second zone. In one embodiment, the first cosmetic treatment zone includes a substantially linear sequence of positions, and the second cosmetic treatment zone includes a substantially linear sequence of positions, wherein the second set of positions. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic therapy using amplitude modulation, wherein multiple portions of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, wherein the first amplitude is distinct from the second amplitude.

[0030] In one embodiment, the ultrasonic transducer is configured to apply an ultrasonic therapy phase shift, in which case multiple parts of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase. In another embodiment, the ultrasonic transducer is configured to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. Furthermore, the ultrasonic transducer is configured to apply an ultrasonic therapy phase shift, in which case multiple parts of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase. In one embodiment, the multiple phases include discrete phase values. In another embodiment, the ultrasonic transducer includes a piezoelectric material, and multiple parts of the ultrasonic transducer are configured to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the plurality of changes in the piezoelectric material include at least one of expansion of the piezoelectric material and contraction of the piezoelectric material. In one embodiment, at least a portion of the ultrasonic transducer is configured to emit ultrasonic treatment at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasonic treatment emitted by at least a portion of the piezoelectric body changes over time. In one embodiment, the drive mechanism is configured to be programmable to provide variable spacing between a plurality of individual cosmetic treatment zones and further includes one or more selectable tuning circuits. In one embodiment, a sequence consisting of a plurality of individual cosmetic treatment zones has treatment intervals ranging from 1 mm to 25 mm and further includes tuning circuits. In one embodiment, the ultrasonic treatment is at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, skin tightening, venous reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, cellulite treatment, décolletage treatment, vaginal rejuvenation, and acne treatment. In one embodiment, the ultrasonic transducer is configured to provide an ultrasonic therapeutic acoustic output in the range of 10W to 100W and a frequency of 1MHz to 12MHz in order to thermally heat the tissue and induce coagulation.

[0031] In various embodiments, a treatment system for simultaneously generating multiple focal points at different depths using a single ultrasonic transducer, the system comprising: an ultrasonic probe including a first switch for operably controlling an ultrasonic imaging function to provide ultrasonic imaging; a second switch for operably controlling an ultrasonic treatment function to provide ultrasonic treatment; and a drive mechanism configured to guide ultrasonic treatment to form at least one sequence of a plurality of individual thermal cosmetic treatment zones; a transducer module configured to apply ultrasonic treatment by at least one of the group consisting of amplitude modulation polarization and phase shift, configured to perform both ultrasonic imaging and ultrasonic treatment, configured to be coupled to the ultrasonic probe, and configured to apply ultrasonic treatment to tissue at a plurality of locations having at least two focal depths, and configured to be operably coupled to at least one of the first switch, the second switch and the drive mechanism; and a control module for controlling the transducer module, the control module including a processor and a display.

[0032] In one embodiment, the ultrasound treatment is a cosmetic treatment, and the locations are arranged in a substantially linear sequence within a cosmetic treatment zone. In one embodiment, the ultrasound treatment is an aesthetic treatment, and a first set of locations is arranged within a first treatment zone, and a second set of locations is arranged within a second treatment zone, the first zone being distinct from the second zone. In one embodiment, the first treatment zone includes a substantially linear sequence consisting of a first set of locations, and the second treatment zone includes a substantially linear sequence consisting of a second set of locations. In one embodiment, the transducer module is configured to apply ultrasound therapy using amplitude modulation, in which case the plurality of parts of the transducer module are configured to emit ultrasound therapy at multiple amplitudes of acoustic intensity, the first amplitude being distinct from the second amplitude. In one embodiment, the transducer module is configured to apply ultrasound therapy phase shift, in which case the plurality of parts of the transducer module are configured to emit ultrasound therapy at multiple phases of acoustic intensity, the first phase being distinct from the second phase. In one embodiment, the transducer module is configured to apply ultrasound therapy using amplitude modulation, in which case multiple parts of the transducer module are configured to emit ultrasound therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. Furthermore, it is configured to apply ultrasound therapy phase shift, in which case multiple parts of the transducer module are configured to emit ultrasound therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase. In one embodiment, the multiple phases include discrete phase values. In one embodiment, the transducer module includes a piezoelectric material, and multiple parts of the transducer module are configured to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the transducer module. In one embodiment, the plurality of changes in the piezoelectric material include at least one of expansion of the material and contraction of the material. In one embodiment, at least part of the transducer module is configured to emit ultrasound therapy at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasound therapy emitted by at least part of the transducer module changes over time.In one embodiment, the drive mechanism is configured to be programmable to provide variable spacing between a plurality of individual thermal cosmetic treatment zones. In one embodiment, a sequence of a plurality of individual thermal cosmetic treatment zones has treatment intervals ranging from 1 mm to 25 mm. In one embodiment, the first and second switches include buttons or keys operated by the user. In one embodiment, at least one of the first and second switches of the treatment system is activated by a control module. In one embodiment, the function of the treatment is at least one of facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, cellulite treatment, décolletage treatment, vaginal rejuvenation, and acne treatment. In one embodiment, the transducer module is configured to provide an ultrasonic therapeutic acoustic output in the range of 10W to 1000W and a frequency of 1MHz to 20MHz in order to thermally heat the tissue and induce coagulation.

[0033] In various embodiments, a treatment system for delivering simultaneous treatment at multiple depths includes a control device that operably controls an ultrasound treatment function to provide ultrasound treatment, and a hand wand configured to guide ultrasound treatment to form a sequence of multiple individual thermal cosmetic treatment zones, the hand wand including a transducer configured to apply ultrasound treatment to tissue at a location at a focal depth, the location being located within a thermal cosmetic treatment zone, and the transducer further configured to apply ultrasound treatment to tissue simultaneously at multiple locations at a focal depth.

[0034] In various embodiments, a method for performing a non-invasive cosmetic procedure on the skin by generating multiple simultaneous focal points at multiple depths using a single transducer, the method comprising coupling a transducer module with an ultrasound probe, wherein the ultrasound probe includes a first switch for controlling acoustic imaging, a second switch for controlling acoustic treatment to induce multiple individual cosmetic treatment zones, and a drive mechanism for providing desired spacing between the multiple individual cosmetic treatment zones; bringing the transducer module into contact with the skin surface of a subject; activating the first switch on the ultrasound probe to acoustically image a region below the skin surface using the transducer module; and activating the second switch on the ultrasound probe to acoustically treat a region below the skin surface using the transducer module in a desired sequence of multiple individual cosmetic treatment zones controlled by the drive mechanism, wherein the transducer module includes a single ultrasound transducer configured to apply ultrasound treatment to tissue at multiple focal depths.

[0035] In various embodiments, an ultrasound treatment system for simultaneously generating multiple foci at multiple depths within tissue using a single ultrasound transducer, the system comprising a control device for operably controlling the ultrasound treatment function to provide ultrasound treatment, and a hand wand configured to guide ultrasound treatment to form a sequence of multiple individual thermal cosmetic treatment zones, the hand wand including a transducer configured to apply ultrasound treatment to tissue at multiple locations at focal depths.

[0036] In various embodiments, an imaging and treatment system for use in cosmetic procedures at multiple depths within tissue, the system comprising: an ultrasound probe configured to perform ultrasound imaging and ultrasound treatment of tissue at multiple depths of focus, the ultrasound probe including a transducer module configured to be coupled to the ultrasound probe, the transducer module including an ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations at depths of focus; a first switch for operably controlling the ultrasound imaging function to provide ultrasound imaging; a second switch for operably controlling the ultrasound treatment function to provide ultrasound treatment; a drive mechanism configured to guide ultrasound treatment to form at least one sequence of multiple individual thermal cosmetic treatment zones, the transducer module configured to be operably coupled to at least one of the first switch, the second switch, and the drive mechanism; and a control module, the control module including a processor and a display for controlling the transducer module.

[0037] In one embodiment, a plurality of positions are arranged in a substantially linear sequence within a cosmetic treatment zone. In one embodiment, a first set of a plurality of positions is arranged within a first cosmetic treatment zone, and a second set of a plurality of positions is arranged within a second cosmetic treatment zone, the first zone being distinct from the second zone. In one embodiment, the first cosmetic treatment zone includes a substantially linear sequence consisting of the first set of a plurality of positions, and the second cosmetic treatment zone includes a substantially linear sequence consisting of the second set of a plurality of positions. In one embodiment, the transducer module is configured to apply ultrasound therapy using amplitude modulation, in which case a plurality of parts of the transducer module are configured to emit ultrasound therapy at multiple amplitudes of acoustic intensity, the first amplitude being distinct from the second amplitude. In one embodiment, the transducer module is configured to apply ultrasound therapy phase shift, in which case a plurality of parts of the transducer module are configured to emit ultrasound therapy at multiple phases of acoustic intensity, the first phase being distinct from the second phase. In one embodiment, the transducer module is configured to apply ultrasound therapy using amplitude modulation, in which case multiple parts of the transducer module are configured to emit ultrasound therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. Furthermore, it is configured to apply ultrasound therapy phase shift, in which case multiple parts of the transducer module are configured to emit ultrasound therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase. In one embodiment, the multiple phases include discrete phase values. In one embodiment, the transducer module may include a piezoelectric material, and multiple parts of the transducer module are configured to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the transducer module. In one embodiment, the plurality of changes in the piezoelectric material include at least one of expansion of the material and contraction of the material. In one embodiment, at least part of the transducer module may be configured to emit ultrasound therapy at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasound therapy emitted by at least part of the transducer module changes over time.In one embodiment, the drive mechanism is configured to be programmable to provide variable spacing between a plurality of individual thermal cosmetic treatment zones. In one embodiment, a sequence of a plurality of individual thermal cosmetic treatment zones has treatment intervals ranging from 0.01 mm to 25 mm. In one embodiment, the first and second switches include buttons or keys operated by the user. In one embodiment, at least one of the first and second switches is activated by a control module. In one embodiment, the function of the treatment is at least one of facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, vaginal rejuvenation, and acne treatment. In one embodiment, the transducer module can be configured to provide an acoustic output for ultrasonic treatment ranging from 10 W to 1000 W and a frequency of 1 MHz to 10 MHz in order to thermally heat tissue and cause coagulation.

[0038] In various embodiments, a multifocal ultrasound treatment system for simultaneous treatment at multiple depths includes a control device that operably controls an ultrasound treatment function to provide ultrasound treatment, and a hand wand configured to guide ultrasound treatment to form a sequence of multiple individual thermal cosmetic treatment zones, the hand wand including a transducer configured to apply ultrasound treatment to tissue at a location at a focal depth, the locations being located within a thermal cosmetic treatment zone, and the transducer further configured to apply ultrasound treatment to tissue simultaneously at multiple locations at a focal depth.

[0039] In various embodiments, a multi-depth imaging and simultaneous multi-focus treatment system includes a module comprising an ultrasonic transducer, the ultrasonic transducer configured to apply ultrasound treatment to tissue at multiple focal depths by at least one of the group consisting of amplitude modulation polarization and phase shift, and the module further includes an interface guide designed to be detachably coupled to a handwand so as to provide electronic communication and power between the module and the handwand.

[0040] In one embodiment, a plurality of positions are arranged in a substantially linear sequence within a cosmetic treatment zone. In one embodiment, a first set of a plurality of positions is arranged within a first cosmetic treatment zone, and a second set of a plurality of positions is arranged within a second cosmetic treatment zone, the first zone being distinct from the second zone. In one embodiment, the first cosmetic treatment zone includes a substantially linear sequence consisting of the first set of a plurality of positions, and the second cosmetic treatment zone includes a substantially linear sequence consisting of the second set of a plurality of positions. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic therapy using amplitude modulation, in which case a plurality of parts of the ultrasonic transducer are configured to emit ultrasonic therapy at a plurality of amplitudes of acoustic intensity, the first amplitude being distinct from the second amplitude. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic therapy phase shift, in which case a plurality of parts of the ultrasonic transducer are configured to emit ultrasonic therapy at a plurality of phases of acoustic intensity, the first phase being distinct from the second phase. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. Furthermore, it is configured to apply ultrasonic therapy phase shift, in which case multiple parts of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple phases of acoustic intensity, 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 multiple parts of the ultrasonic transducer are configured to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the plurality of changes in the piezoelectric material include at least one of expansion of the piezoelectric material and contraction of the piezoelectric material. In one embodiment, at least part of the ultrasonic transducer is configured to emit ultrasonic therapy at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasonic therapy emitted by at least part of the piezoelectric material changes over time. In one embodiment, the imaging and treatment system includes a drive mechanism configured to be programmable to provide spacing between a plurality of individual cosmetic treatment zones.In one embodiment, a sequence consisting of multiple individual cosmetic treatment zones has treatment intervals ranging from 1 mm to 50 mm. In one embodiment, the ultrasound treatment is at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, vaginal rejuvenation, and acne treatment. In one embodiment, the ultrasound transducer can be configured to provide an acoustic output for ultrasound treatment ranging from 1 W to 100 W and a frequency ranging from 1 MHz to 10 MHz in order to thermally heat the tissue and cause coagulation.

[0041] In various embodiments, a treatment system for simultaneous treatment at multiple depths includes a control device that operably controls an ultrasound treatment function to provide ultrasound treatment, and a hand wand configured to guide ultrasound treatment to form a sequence of multiple individual thermal cosmetic treatment zones, the hand wand including an ultrasound transducer configured to simultaneously apply ultrasound treatment to tissue at multiple locations at focal depth.

[0042] In various embodiments, a non-invasive method for simultaneously performing cosmetic procedures at multiple depths that are not performed by a physician, the method comprising coupling a transducer module with an ultrasound probe, wherein the transducer module includes an ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations at the depth of focus by at least one of the group consisting of amplitude modulation polarization and phase shift, and the ultrasound probe includes a first switch for controlling acoustic imaging, a second switch for controlling acoustic treatment to induce multiple individual cosmetic treatment zones, and a drive mechanism for providing desired spacing between the multiple individual cosmetic treatment zones, the method comprising coupling the transducer module with an ultrasound probe, bringing the transducer module into contact with the skin surface of a subject, activating the first switch on the ultrasound probe to acoustically image a region below the skin surface, and activating the second switch on the ultrasound probe to acoustically treat a region below the skin surface by the transducer module in a desired sequence of multiple individual cosmetic treatment zones controlled by the drive mechanism.

[0043] In various embodiments, an ultrasonic treatment system for dithering multiple simultaneous focal points from a single ultrasonic transducer at multiple depths includes an ultrasonic probe having a single transducer element adapted to simultaneously apply ultrasonic treatment to tissue at multiple focal depths spaced apart from each other, wherein the ultrasonic transducer is polarized by at least a first polarization configuration and a second polarization configuration; and a control module coupled to the ultrasonic probe for controlling the ultrasonic transducer, which can change the distance between spaced-apart positions via dithering of the first and second focal zones, thereby allowing precise movement of the beam focal points at spaced-apart positions by dithering via frequency modulation.

[0044] In one embodiment, multiple locations are arranged in a linear sequence within a cosmetic treatment zone, and spaced-apart locations are separated by spatial dithering via frequency swing. In one embodiment, a first set of multiple locations is located within a first cosmetic treatment zone, and a second set of multiple locations is located within a second cosmetic treatment zone, the first zone being distinct from the second zone. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, the first amplitude being distinct from the second amplitude. In one embodiment, at least a portion of the ultrasonic transducer is adapted to emit ultrasonic therapy at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasonic therapy emitted by at least a portion of the piezoelectric material changes over time. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and multiple parts of the ultrasonic transducer are adapted to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the plurality of changes in the piezoelectric material include at least one of expansion of the piezoelectric material and contraction of the piezoelectric material. In one embodiment, the ultrasonic transducer can be adapted to apply ultrasonic therapy via phase shift, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, 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 can be adapted to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude, and further adapted to apply ultrasonic therapy, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase.In one embodiment, the ultrasound treatment is at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, décolletage improvement, buttock lift, scar reduction, burn treatment, skin tightening, vasoconstriction, sweat gland treatment, sunspot removal, fat treatment, abdominal relaxation treatment, and cellulite treatment. In one embodiment, the ultrasound probe may include a drive mechanism adapted to guide the ultrasound treatment to form at least one pair of simultaneous sequences consisting of a plurality of individual thermal cosmetic treatment zones. In one embodiment, the ultrasound probe is configured to perform both ultrasound imaging and ultrasound treatment. In one embodiment, the ultrasound probe may include a transducer module adapted to apply ultrasound treatment.

[0045] In various embodiments, an ultrasound treatment system for use in cosmetic procedures for dithering multiple simultaneous focal points from a single ultrasound transducer at multiple depths, the system comprising: an ultrasound probe, which includes a control module adapted to change the distance between a first focal zone and a second focal zone via dithering; a switch for operably controlling the ultrasound treatment function to provide ultrasound treatment; and a drive mechanism adapted to guide ultrasound treatment to form at least one pair of simultaneous sequences consisting of multiple individual thermal cosmetic treatment zones; a transducer module adapted to apply ultrasound treatment, which includes an ultrasound transducer adapted to perform both ultrasound imaging and ultrasound treatment, adapted to be coupled to the ultrasound probe, and adapted to apply ultrasound treatment to tissue at multiple locations having at least two focal depths, and adapted to be operably coupled to at least one of the switch and the drive mechanism; and a control module, which includes a processor and a display for controlling the transducer module.

[0046] In one embodiment, the transducer module is adapted to apply ultrasound therapy using amplitude modulation, in which case multiple parts of the transducer module are adapted to emit ultrasound therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. In another embodiment, the transducer module is adapted to apply ultrasound therapy, in which case multiple parts of the transducer module are adapted to emit ultrasound therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase.

[0047] In various embodiments, an ultrasonic treatment system for dithering simultaneous multifocal treatment at multiple depths includes a module comprising an ultrasonic transducer adapted to simultaneously apply ultrasonic treatment to tissue at multiple spaced depths within the tissue, the module changing the spacing between the spaced depths via dithering between a first focal zone and a second focal zone, thereby allowing precise movement of the beam focal point at the spaced depths by frequency-modulated dithering, and the module further includes an interface guide designed to be detachably coupled to a handwand so as to provide electronic communication and power between the module and the handwand.

[0048] In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and multiple parts of the ultrasonic transducer are adapted to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, at least a portion of the ultrasonic transducer can be adapted to emit ultrasonic therapy at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasonic therapy emitted by at least a portion of the ultrasonic transducer remains constant over time. In one embodiment, ultrasound treatment is at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, décolletage improvement, buttock lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, cellulite treatment, abdominal relaxation treatment, vaginal rejuvenation, and acne treatment.

[0049] In various embodiments, a method for dithering multiple simultaneously focused ultrasound treatment beams at multiple depths includes preparing an ultrasound probe including an ultrasound transducer having a single converter element adapted to simultaneously apply ultrasound treatment to tissue at multiple spaced positions at multiple focal depths, and a control module coupled to the ultrasound probe for controlling the ultrasound transducer, and moving the position of the ultrasound focus at multiple spaced positions by dithering the spacing between multiple spaced positions of a first focal zone and a second focal zone via frequency modulation.

[0050] In one embodiment, the method further includes imaging a first focal zone with an ultrasonic image sensor. In one embodiment, the method further includes imaging a second focal zone with an ultrasonic image sensor. In one embodiment, the distance between the first and second focal zones is dithered in the range of 1% to 50%. In one embodiment, the distance between the first and second focal zones is 1.5 mm, in increments of 0.1 mm. In one embodiment, the frequency modulation is in the range of 1% to 50%. In one embodiment, the ultrasound treatment is at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, décolletage improvement, buttock lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, vaginal rejuvenation, abdominal relaxation treatment, and acne treatment.

[0051] In various embodiments, a method for simultaneously dithering a single focused ultrasound beam at multiple depths comprises preparing an ultrasound probe including a single transformer and a control module, wherein the single transformer is adapted to apply ultrasound therapy to tissue in a focal zone at the depth of focus, and the control module is coupled to the ultrasound probe to control the single transformer, and the size of the focal zone at the tissue is changed by dithering the focal zone via frequency modulation.

[0052] In one embodiment, the relative position of the focal zone is dithered in the range of 1% to 50%. In one embodiment, the second focal zone is emitted simultaneously from a single conversion element. In one embodiment, the frequency modulation is in the range of 1% to 50%. In one embodiment, the system is designed to operate non-invasively when treating tissue. In one embodiment, this method functions in a non-invasive manner when treating tissue.

[0053] In various embodiments, an ultrasonic treatment system for delivering simultaneous multi-focus treatment at multiple depths by an electrostrictive element includes a module comprising an ultrasonic transducer, which is adapted to simultaneously apply ultrasonic treatment to tissue at multiple spaced depths within the tissue by application of an electrostrictive element, the module modulates the spacing between the multiple spaced depths via dithering of first and second focal zones, thereby allowing precise movement of the beam focus at the multiple spaced depths by frequency modulation-mediated dithering, and the module further includes an interface guide designed to be detachably coupled to a handwand so as to provide electronic communication and power between the module and the handwand.

[0054] In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and multiple parts of the ultrasonic transducer are adapted to generate a plurality of corresponding changes in the piezoelectric material 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 emit ultrasonic therapy at two or more amplitudes of acoustic intensity, and 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 at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, décolletage improvement, buttock lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, cellulite treatment, abdominal relaxation treatment, vaginal rejuvenation, and acne treatment.

[0055] In various embodiments, an ultrasonic treatment system having one or more of the features described above is provided. In various embodiments, a method for reducing imaging displacement in a moving ultrasonic transducer is provided, having one or more of the features described above. In various embodiments, an ultrasonic treatment system for generating multiple simultaneous focuses from a single ultrasonic transducer is provided, having one or more of the features described above. In various embodiments, an ultrasonic treatment system for delivering multi-focus treatment is provided, having one or more of the features described above. In various embodiments, an ultrasonic treatment module for use in cosmetic treatment is provided for forming multiple simultaneous focus zones from a single ultrasonic transducer, having one or more of the features described above. In various embodiments, a method for generating multiple simultaneously focused ultrasonic treatment beams using multi-channel signal mixing is provided, having one or more of the features described above. In various embodiments, a method for generating multiple simultaneously focused ultrasonic beams is provided, having one or more of the features described above.

[0056] In some embodiments described herein, the procedures are entirely cosmetic and not medical. For example, in one embodiment, the method described herein does not need to be performed by a physician and can be performed in a spa or other aesthetic facility. In some embodiments, the system can be used for non-invasive cosmetic treatment of the skin.

[0057] It should be understood that while the methods summarized above and described in more detail below describe specific actions performed by the practitioner, they may also include instructions from others regarding those actions. Therefore, actions such as "dithering the energy beam" include "instructing to dither the energy beam."

[0058] In some embodiments, the system includes various features that exist as a single feature (as opposed to multiple features). For example, in one embodiment, the system includes a single transform element that generates two simultaneous treatment foci that are dithered. In alternative embodiments, multiple features or components are provided. In various embodiments, the system includes, or substantially consists of, one, two, three, or more embodiments of any feature or component disclosed herein. In some embodiments, features or components are not included and may be negatively discarded from certain claims so that the system does not have such features or components.

[0059] Furthermore, the areas of applicability will become apparent from the descriptions provided herein. It will be understood that the descriptions and specific examples are for illustrative purposes only and are not intended to limit the scope of the embodiments disclosed herein.

[0060] The drawings described herein are for illustrative purposes only and are not intended to limit the scope of this disclosure in any way. Embodiments of the present invention will be better understood from the detailed description and accompanying drawings. [Brief explanation of the drawing]

[0061] [Figure 1A] Figure 1A shows schematic diagrams of ultrasonic systems according to various embodiments of the present invention.

[0062] [Figure 1B] Figure 1B shows schematic diagrams of ultrasonic systems according to various embodiments of the present invention.

[0063] [Figure 1C] Figure 1C shows schematic diagrams of ultrasonic systems according to various embodiments of the present invention.

[0064] [Figure 2] Figure 2 shows schematic diagrams of ultrasonic systems coupled to a region of interest according to various embodiments of the present invention.

[0065] [Figure 3] Figure 3 shows a schematic diagram of some of the converters according to various embodiments of the present invention.

[0066] [Figure 4] Figure 4 shows a partially cutaway side view of an ultrasonic system according to various embodiments of the present invention.

[0067] [Figure 5] Figure 5 is a table showing the focal spacing for apertures with different spatial frequencies according to various embodiments of the present invention.

[0068] [Figure 6] Figure 6 is a plot showing the focal spacing for apertures with different aperture spatial frequencies according to various embodiments of the present invention.

[0069] [Figure 7] Figure 7 is a plot showing the focal spacing for apertures having different aperture spatial frequencies according to various embodiments of the present invention.

[0070] [Figure 8] Figure 8 shows schematic representations of aperture polarization with spatial frequencies that can be modified by channel excitation, according to various embodiments of the present invention.

[0071] [Figure 9] Figure 9 shows a schematic representation of a polarized ceramic having a spatial frequency that can be modified by channel excitation covering two polarization regions of the ceramic, according to various embodiments of the present invention.

[0072] [Figure 10]Figure 10 shows a schematic representation of one embodiment of an array converter having an imaging converter.

[0073] [Figure 11] Figure 11 is a schematic illustration of a transducer according to various embodiments of the present invention, showing a view from the convex side, a side cross-sectional view, and a view from the concave side.

[0074] [Figure 12] Figure 12 is a schematic illustration of a transducer according to various embodiments of the present invention, showing a view from the convex side, a side cross-sectional view, and a view from the concave side.

[0075] [Figure 13] Figure 13 is a schematic illustration of a transducer according to various embodiments of the present invention, showing a view from the convex side, a side cross-sectional view, and a view from the concave side.

[0076] [Figure 14] Figure 14 is a schematic illustration of a transducer according to various embodiments of the present invention, showing a view from the convex side, a side cross-sectional view, and a view from the concave side.

[0077] [Figure 15] Figure 15 is a schematic illustration of a transducer according to various embodiments of the present invention, showing a view from the convex side, a side cross-sectional view, and a view from the concave side.

[0078] [Figure 16] Figure 16 is a schematic illustration of a transducer according to various embodiments of the present invention, showing a view from the convex side, a side cross-sectional view, and a view from the concave side.

[0079] [Figure 17] Figure 17 is a schematic illustration of a transducer according to various embodiments of the present invention, showing a view from the convex side and a view from the concave side.

[0080] [Figure 18]Figure 18 shows schematic diagrams of multiple thermal solidification zones at various depths generated by transducers according to various embodiments of the present invention.

[0081] [Figure 19] Figure 19 shows a schematic view from the xz plane of multiple thermal solidification zones at various depths, generated by the transducer shown in Figure 18.

[0082] [Figure 20] Figure 20 shows a schematic view from the yz plane of multiple thermal solidification zones at various depths, generated by the converter shown in Figure 18.

[0083] [Figure 21] Figure 21 shows schematic diagrams of multiple thermal solidification zones at various depths generated by transducers according to various embodiments of the present invention.

[0084] [Figure 22] Figure 22 shows a schematic view from the xz plane of multiple thermal solidification zones at various depths, generated by the transducer shown in Figure 21.

[0085] [Figure 23] Figure 23 shows a schematic view from the yz plane of multiple thermal solidification zones at various depths, generated by the converter shown in Figure 21.

[0086] [Figure 24] Figure 24 shows schematic diagrams of multiple thermal solidification zones at various depths generated by transducers according to various embodiments of the present invention.

[0087] [Figure 25] Figure 25 shows a schematic view from the xz plane of multiple thermal solidification zones at various depths, generated by the transducer shown in Figure 24.

[0088] [Figure 26] Figure 26 shows a schematic view from the yz plane of multiple thermal solidification zones at various depths, generated by the converter shown in Figure 24.

[0089] [Figure 27] Figure 27 shows schematic diagrams of multiple thermal solidification zones at various depths generated by transducers according to various embodiments of the present invention.

[0090] [Figure 28] Figure 28 shows a schematic view from the xz plane of multiple thermal solidification zones at various depths, generated by the converter shown in Figure 27.

[0091] [Figure 29] Figure 29 shows a schematic view from the yz plane of multiple thermal solidification zones at various depths, generated by the converter shown in Figure 27.

[0092] [Figure 30] Figure 30 is a schematic illustration of a transducer according to various embodiments of the present invention, showing a view from the convex side and a view from the concave side.

[0093] [Figure 31] Figure 31 shows schematic diagrams of multiple thermal solidification zones at various depths generated by transducers according to various embodiments of the present invention.

[0094] [Figure 32] Figure 32 shows a schematic view from the xz plane of multiple thermal solidification zones at various depths, generated by the converter shown in Figure 31.

[0095] [Figure 33] Figure 33 shows a schematic view from the yz plane of multiple thermal solidification zones at various depths, generated by the converter shown in Figure 31.

[0096] [Figure 34] Figure 34 shows schematic diagrams of multiple thermal solidification zones at various depths generated by transducers according to various embodiments of the present invention.

[0097] [Figure 35] Figure 35 shows a schematic view from the xz plane of multiple thermal solidification zones at various depths, generated by the converter shown in Figure 34.

[0098] [Figure 36] Figure 36 shows a schematic view from the yz plane of multiple thermal solidification zones at various depths, generated by the converter shown in Figure 34.

[0099] [Figure 37] Figure 37 is a plot showing the amplitude and DC corresponding to the focal plane focal point, generated by converters according to various embodiments of the present invention. [Modes for carrying out the invention]

[0100] The following description illustrates examples of embodiments and is not intended to limit the invention, its teaching, its application, or its use. Throughout the drawings, corresponding reference numerals indicate similar or corresponding parts and features. Descriptions of specific examples shown in various embodiments of the invention are for illustrative purposes only and are not intended to limit the scope of the invention disclosed herein. Furthermore, the enumeration of multiple embodiments having the described features is not intended to exclude other embodiments having additional features, nor is it intended to exclude other embodiments having different combinations of the described features. Moreover, features in one embodiment (for example, in one figure) can be combined with descriptions (and figures) of other embodiments.

[0101] In various embodiments, systems and methods for ultrasound treatment of tissues are adapted and / or configured to provide cosmetic treatments. In some embodiments, devices and methods are provided for performing ultrasound treatment on a single focus or on multiple simultaneous focuses, wherein sufficient acoustic coupling to the treatment area can be confirmed by using ultrasound imaging, thereby improving performance during image formation in cosmetic and / or medical procedures, or improving the correlation between movement in a first direction and movement in a second direction. In various embodiments used herein, “simultaneous” means occurring at the same time or with a time difference of less than 1 ms, less than 0.5 ms, less than 0.1 ms, less than 0.05 ms, or less than 0.01 ms. In various embodiments, tissues below the skin surface, or even tissues at the skin surface, such as the epidermis, dermis, fascia, muscle, fat, and superficial muscular aponeurotic system ("SMAS"), are treated non-invasively with ultrasound energy. Ultrasound energy can be focused on one or more treatment points and / or treatment zones to obtain cosmetic and / or therapeutic effects, or it can be unfocused and / or blurred, and it can be applied to areas of interest including at least one of the epidermis, dermis, subcutaneous tissue, fascia, muscle, fat, cellulite, and SMAS. In various embodiments, the system and / or method provides non-invasive dermatological treatment to tissue through thermal treatment, coagulation, cauterization, and / or tightening. In some embodiments disclosed herein, by using non-invasive ultrasound, one or more of the following various effects can be obtained:In other words, one or more of the following effects can be obtained: facelift, eyebrow lift, chin lift, eye treatment (e.g., cheek pouch, infraorbital laxity treatment), wrinkle reduction, fat reduction (e.g., fat and / or cellulite treatment), cellulite treatment (e.g., dimple-type or non-dimple-type female articular lipodystrophy), décolletage improvement (e.g., upper chest), buttock lift (e.g., buttock tightening), skin laxity treatment (e.g., tissue treatment for tightening, or abdominal laxity treatment), scar reduction, burn treatment, tattoo removal, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, acne treatment, and acne reduction. In one embodiment, fat reduction is achieved. In various embodiments, a reduction in cellulite (e.g., dimpled or non-dimpled fossa lipodystrophy), or improvement of one or more features (e.g., dimples, nodule formation, "orange peel" appearance, etc.) can be achieved, for example, by approximately 10%–20%, 20%–40%, 40%–60%, 60%–80%, or more (and the overlapping portion thereof) compared to untreated tissue. In one embodiment, décolletage is treated. In some embodiments, two, three, or more beneficial effects can be obtained during and simultaneously in the same treatment session.

[0102] Various embodiments of the present invention relate to devices or methods for controlling the delivery of energy to tissue. In various embodiments, various forms of energy may include acoustic, ultrasonic, optical, laser, radio frequency (RF), microwave, electromagnetic, radiant, thermal, cryogenic, electron beam, photon-based, magnetic, magnetic resonance, and / or other forms of energy. Various embodiments of the present invention relate to devices or methods for splitting one ultrasonic energy beam into multiple beams. In various embodiments, by using the device or method, the delivery of ultrasonic acoustic energy can be modified in any procedure, including, but not limited to, therapeutic ultrasound, diagnostic ultrasound, ultrasonic welding, any application including coupling mechanical waves to a subject, and other procedures. Generally, with therapeutic ultrasound, tissue effects are obtained by concentrating acoustic energy using focusing techniques from an aperture. In some cases, high-intensity focused ultrasound (HIFU) is used for such therapeutic purposes. In one embodiment, the tissue effect produced by the application of therapeutic ultrasound to a specific depth can be referred to as the generation of thermal coagulation points (TCPs). In some embodiments, a zone may include points. In some embodiments, a zone may be a line, plane, sphere, ellipse, cube, or other one-dimensional, two-dimensional, or three-dimensional shape. The thermal and / or mechanical cauterization of tissue may occur non-invasively or remotely by generating TCPs at specific locations. 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.

[0103] In one embodiment, TCPs can be generated in linear or substantially linear, curved or substantially curved zones or sequences, with individual TCPs spaced apart from adjacent TCPs by the treatment interval. In one embodiment, multiple sequences of TCPs can be generated within a treatment area. For example, TCPs can be formed along a first sequence and along a second linear sequence spaced apart from the first sequence by the treatment distance. While therapeutic ultrasound treatment can be performed by generating individual TCPs within one or more sequences of individual TCPs, it may be desirable to reduce treatment time and the corresponding risk of pain and / or discomfort experienced by the patient. Treatment time can be reduced by forming multiple TCPs simultaneously, nearly simultaneously, or sequentially. In some embodiments, the processing time can be reduced by 10%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, or more by generating multiple TCPs.

[0104] Various embodiments of the present invention address potential challenges arising from the implementation of ultrasound therapy. In various embodiments, the time required to form TCPs for cosmetic and / or therapeutic treatment is reduced with respect to the desired clinical approach at the target tissue. In various embodiments, the target tissue is any of the following, but is not limited to, skin, eyelids, eyelashes, eyebrows, lacrimal caruncle, crow's feet, wrinkles, eyes, nose, mouth (e.g., nasolabial folds, perioral wrinkles), tongue, teeth, gums, ears, brain, heart, lungs, ribs, abdomen (e.g., with respect to abdominal flaccidity), stomach, liver, kidneys, uterus, chest, vagina, prostate, testes, glands, thyroid, viscera, hair, muscle, bone, ligaments, cartilage, fat, fat labuli, adipose tissue, subcutaneous tissue, transplanted tissue, transplanted organs, lymphocytes, tumors, cysts, abscesses, parts of nerves, or any combination thereof.

[0105] Various embodiments relating to simultaneous ultrasound treatment at multiple locations within tissue are described in U.S. Patent Application No. 14 / 193,234, published on September 11, 2014, as U.S. Patent Application Publication No. 2014 / 0257145, which is incorporated herein by reference in its entirety.

[0106] System Overview Referring to Figures 1A, 1B, and 1C, various embodiments of the ultrasonic system 20 include a hand wand (e.g., a handpiece) 100, modules (e.g., a transducer module, cartridge, probe) 200, and a controller (e.g., a console) 300. In some embodiments, the console 300 includes a communication system (e.g., Wi-Fi®, Bluetooth®, modem, etc.) for communicating with others, manufacturers, suppliers, service providers, the Internet, and / or the cloud. In some embodiments, a cart 301 provides mobility and / or positioning of the system 20 and may include wheels, a surface for writing on or placing materials, and / or compartments 302 (e.g., drawers, containers, shelves, etc.) for storing or organizing materials. In some embodiments, the cart has a power source, such as a power connection to a battery, and / or one or more cords for connecting power or communication (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 a cart 301. The hand wand 100 can be coupled to the controller 300 by an interface 130 which can be either a wired or wireless interface. The interface 130 can be coupled to the hand wand 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 hand wand 100. In one embodiment, the system 20 has multiple imaging channels (e.g., 8 channels) for ultra-high-definition (HD) visualization of subcutaneous structures to improve imaging. In one embodiment, the system 20 has multiple treatment channels (e.g., 8 channels) and a precision linear drive motor that doubles the treatment accuracy while increasing the speed (e.g., by 25%, 40%, 50%, 60%, 75%, 100%, or more).In summary, these features establish one of the most versatile system platforms in the industry and provide foundational technologies for unprecedented future possibilities.

[0107] In various embodiments, the controller 300 can be adapted and / or configured to operate together with the hand wand 100 and module 200, and together with the overall functionality of the ultrasonic system 20. In various embodiments, multiple controllers 300, 300', 300”, etc., can be adapted and / or configured to operate together with multiple hand wands 100, 100', 100”, etc., and / or with multiple modules 200, 200', 200”, etc. A controller 300 may include connectivity to one or more interactive graphic displays 310, which may include a touchscreen monitor and a graphic user interface (GUI) that allows a user to interact with the ultrasound system 20. In one embodiment, a second smaller and more portable display allows a user to more easily position and view the treatment screen. In one embodiment, the second display allows a user of the system to view the treatment screen (e.g., on a wall, on a portable device, on a large screen, on a remote screen). In one embodiment, the graphic display 310 This includes a touchscreen interface 315 (not shown). In various embodiments, the display 310 sets and displays operating conditions, i.e., operating conditions including the operating state of the device, treatment parameters, system messages and prompts, and ultrasound images. In various embodiments, the controller 300 can be adapted and / or configured to include, for example, a microprocessor having software and input / output devices, a system and devices for controlling electronic and / or mechanical scanning, and / or controlling the multiplexing of transducers, and / or controlling the multiplexing of transducer modules, a system for power transmission, a system for monitoring, a system for sensing the spatial position of probes and / or transducers, and / or sensing the multiplexing of transducer modules, and / or a system for processing user input and recording treatment results.In various embodiments, the controller 300 may include a system processor and various analog and / or digital control logic, and may include one or more of the following: a microcontroller, a microprocessor, a field-programmable gate array, a computer board, and related components, including firmware and control software that can interface to user control, interface circuits, input / output circuits, and systems for communication, display, interface, storage, documentation, and other useful functions. The system software running on the system process can be adapted and / or configured to control all initialization, timing, level setting, monitoring, safety monitoring, and all other ultrasonic system functions relating to achieving user-defined treatment objectives. Furthermore, the controller 300 may include various input / output modules such as switches and buttons, which can similarly be adapted and / or configured to control the operation of the ultrasonic system 20.

[0108] In one embodiment, the hand wand 100 includes a controller or switch activated by one or more fingers, such as those indicated by reference numerals 150 and 160. In various embodiments, one or more thermal treatment controllers 160 (e.g., switches, buttons) activate and / or stop the treatment. In various embodiments, one or more imaging controllers 150 (e.g., switches, buttons) activate and / or stop imaging. In one embodiment, the hand wand 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 hand wand 100 using a latch or coupler 140. In various embodiments, one or more interface guides 235 may be used to assist in coupling the module 200 to the hand wand 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. Module 200 may include one or more ultrasonic elements. Hand wand 100 may include imaging-only modules, treatment-only modules, imaging and treatment modules, and similar modules. In various embodiments, the ultrasonic transducer 280 is movable in one or more directions 290 within module 200. The transducer 280 is connected to a drive mechanism 400. In various embodiments, the drive mechanism may include zero or one or more bearings, shafts, rods, screws, lead screws 401, encoders 402 (e.g., optical encoders for measuring the position of the transducer 280), motors 403 (e.g., stepper motors), etc., to help ensure accurate and repeatable movement of the transducer 280 within module 200. In various embodiments, module 200 may include a transducer 280 that can emit energy through an acoustically transparent member 230.In one embodiment, the control module 300 can be coupled to the hand wand 100 via interface 130, and the graphic user interface 310 can be adapted and / or configured to control module 200. In one embodiment, the control module 300 can supply power to the hand wand 100. In one embodiment, the hand wand 100 can include a power supply. In one embodiment, switch 150 can be adapted and / or configured to control the tissue imaging function, and switch 160 can be adapted and / or configured to control the tissue treatment function. In various embodiments, the delivery of emitted energy 50 at an appropriate depth of field, with an appropriate distribution, at an appropriate timing, and at an appropriate energy level is provided by module 200 through operation controlled by the control system 300 of the transducer 280, thereby obtaining the desired treatment effect by the thermal coagulation zone 550 (e.g., thermal coagulation point, "TCP").

[0109] In one embodiment, module 200 can be coupled to hand wand 100. Module 200 can emit and receive energy, such as ultrasonic energy. Module 200 can be electronically coupled to hand wand 100, and such coupling may include an interface for communicating with controller 300. In one embodiment, interface guide 235 may be adapted and / or configured to provide electronic communication between module 200 and hand wand 100. Module 200 may include various probe configurations and / or various transducer configurations. For example, module 200 may be adapted and / or configured as a composite dual-mode imaging / treatment transducer, as an imaging transducer and a treatment transducer coupled or co-housing, as separate treatment probes and imaging probes, or of the same kind. In one embodiment, when module 200 is inserted into or connected to hand wand 100, controller 300 automatically detects this and updates interactive graphic display 310.

[0110] In some embodiments, an access key 320 (e.g., a secure USB drive, key) is connected to the system 20 (e.g., detachably) to enable the system 20 to function. In various embodiments, the access key is programmed to be customer-specific and provides several functions, including system security, country / region-specific access to action guidelines and functions, software upgrades, and transfer of support logs and / or transfer and / or storage of credits. In various embodiments, the system 20 has internet connectivity and / or data connectivity. In one embodiment, connectivity provides a method for transferring data between the system 20 provider and the customer. In various embodiments, the data includes credits, software updates, and support logs. Connectivity is divided into various model embodiments based on how the user's console is connected to the internet. In one embodiment, disconnected model connectivity includes a console that is disconnected from the internet, and the customer does not have access to the internet. Transfer of credits and software upgrades are performed by sending an access key (e.g., a USB drive) to the customer. In one embodiment, a semi-connected connectivity model includes a console that is disconnected from the internet, but the customer can access the internet. Credit transfers, software upgrades, and support log transfers are performed using the customer's personal computer, smartphone, or other computing device, in combination with a system access key for transferring data. In one embodiment, a fully connected connectivity model includes a console that is wirelessly connected to the internet using Wi-Fi®, a cellular modem, Bluetooth®, or other protocols. Credit transfers, software upgrades, and support log transfers are performed directly between the console and the cloud.In various embodiments, the system 20 is connected to an online portal for efficient inventory management, on-demand treatment purchasing, and business analytics insights, thereby driving the customer's beauty treatment business to the next level.

[0111] In various embodiments, tissues below the skin surface, or even tissues at the skin surface, such as the epidermis, dermis, subcutaneous tissue, fascia, superficial muscular aponeurotic system ("SMAS"), and / or muscles, are treated non-invasively with ultrasound energy. Tissues may also include blood vessels and / or nerves. The ultrasound energy can be focused, unfocused, and / or blurred to achieve a therapeutic effect and can be applied to a region of interest comprising at least one of the epidermis, dermis, subcutaneous tissue, fascia, and SMAS. Figure 2 is a schematic illustration of an ultrasound system 20 coupled to a region of interest 10. In various embodiments, the tissue layers constituting the region of interest 10 can be located in any part of the subject's body. In one embodiment, the tissue layers are located in the area of ​​the subject's head and face. The cross-sectional portion of the tissue constituting the region of interest 10 includes the skin surface 501, the epidermal layer 502, the dermis layer 503, the adipose layer 505, the superficial muscular aponeurotic system (SMAS) 507 (hereinafter referred to as "SMAS 507"), and the muscle layer 509. The tissue may also include subcutaneous tissue 504, which may include any tissue below the dermis layer 503. The combination of these layers may collectively be known as subcutaneous tissue 510. In Figure 2, a treatment zone 525 located below the surface 501 is also illustrated. In one embodiment, the surface 501 may be the skin surface of the subject 500. Although embodiments relating to treatment at tissue layers may be used as examples herein, the system can be applied to any tissue in the body. In various embodiments, the system and / or method can be used with respect to tissues (including, but not limited to, one or a combination thereof, of muscle, fascia, SMAS, dermis, epidermis, fat, adipocytes, cellulite which may be referred to as fossa lipodystrophy (e.g., non-dimpled female fossa lipodystrophy), collagen, skin, blood vessels, etc., in the face, neck, head, arms, legs, or other parts of the body on or within the body (including body cavities)).In various embodiments, reduction of cellulite (e.g., non-dimple type female fossial lipodystrophy) can be achieved by amounts of 2%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 75%, 80%, 90%, 95%, and any range within this range.

[0112] Referring to the illustration in Figure 2, an embodiment of the ultrasound system 20 includes a hand wand 100, a module 200, and a controller 300. In one embodiment, the module 200 includes a transducer 280. Figure 3 shows an embodiment of the ultrasound system 20 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 to be treated. In one embodiment, the focal depth 278 is fixed with respect to a given transducer 280. In one embodiment, the focal depth 278 is variable with respect to a given transducer 280. In one embodiment, the transducer 280 is configured to treat simultaneously at multiple depths below the skin surface (e.g., 1.5 mm, 3.0 mm, 4.5 mm, or other depths).

[0113] Referring to the illustration in Figure 4, the module 200 may include a transducer 280 that can emit energy through an acoustically transparent member 230. In various embodiments, depth may refer to focal depth 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 focal depth 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 a position on the module 200 or on the ultrasound system 20 for contact with the skin surface 501. In various embodiments, the focal depth 278 exceeds the offset distance 270 by an amount corresponding to treatment in a target area located at a tissue depth 279 below the skin surface 501. In various embodiments, when the ultrasound system 20 is positioned in physical contact with the skin surface 501, the tissue depth 279 is the distance between the acoustically transparent member 230 and the target region, measured as the distance from the surface portion of the hand wand 100 or module 200 that is in contact with the skin (with or without an acoustically coupled gel, medium, etc.), and the depth within the tissue from the point of contact on the skin surface to the target region. In one embodiment, the depth of focus 278 can correspond to the sum of the offset distance 270 (measured relative to the surface of the acoustically transparent member 230 in contact with the bonding medium and / or skin 501) and the tissue depth 279 below the skin surface 501 to the target region. In various embodiments, the acoustically transparent member 230 is not used.

[0114] The coupling member may include a variety of substances, materials, and / or devices to facilitate coupling of the transducer 280 or module 200 to the region of interest. For example, the coupling member may include an acoustic coupling system adapted and / or configured to acoustically couple ultrasonic energy and signals. By utilizing an acoustic coupling system having possible connecting members such as manifolds, sound can be coupled into the region of interest, providing focus for a liquid or fluid-filled lens. Such coupling can be facilitated by the use of one or more coupling media, including air, gas, water, liquid, fluid, gel, solid, non-gel, and / or any combination thereof, or any other medium that enables signal transmission 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 separable from the dry portion of the ultrasonic device. In various embodiments, by using a binding medium, ultrasonic energy can be transmitted between one or more devices and tissue with transmission efficiencies 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.

[0115] In various embodiments, the transducer 280 can image and treat a region of interest at any suitable tissue depth 279. In one embodiment, the transducer module 280 can provide acoustic output in the range of about 1W or less, in the range of about 1W to about 100W, and in the range of about 100W or more, such as 200W, 300W, 400W, or 500W. In one embodiment, the transducer module 280 can provide acoustic output at frequencies of about 1MHz or less, in the range of about 1MHz to about 10MHz (e.g., 3MHz, 4MHz, 4.5MHz, 7MHz, 10MHz), and at frequencies greater than about 10MHz. In one embodiment, the module 200 has a depth of focus 278 for treatment at a tissue depth 279, which is about 4.5mm below the skin surface 501. In one embodiment, module 200 has a focal depth 278 for treatment at a tissue depth 279, approximately 3 mm below the skin surface 501. In another embodiment, module 200 has a focal depth 278 for treatment at a tissue depth 279, approximately 1.5 mm below the skin surface 501. Some non-limiting embodiments of the transducer 280 or module 200 can be adapted and / or configured to deliver ultrasonic energy to tissue depths such as 1.5 mm, 3 mm, 4.5 mm, 6 mm, 7 mm, less than 3 mm, 3 mm to 4.5 mm, 4.5 mm to 6 mm, deeper than 4.5 mm, deeper than 6 mm, etc., and to any position within the ranges of 0 mm to 3 mm, 0 mm to 4.5 mm, 0 mm to 6 mm, 0 mm to 25 mm, 0 mm to 100 mm, etc., and any depth within these ranges. In one embodiment, the ultrasonic system 20 is provided with two or more transducer modules 280. For example, the first transducer module can apply the procedure at a first tissue depth (e.g., approximately 4.5 mm), the second transducer module can apply the procedure at a second tissue depth (e.g., approximately 3 mm), and the third transducer module can apply the procedure at a third tissue depth (e.g., approximately 1.5 mm to 2 mm).In one embodiment, at least some, or all, of the transducer modules may be adapted and / or configured to apply the treatment at substantially the same depth.

[0116] In various embodiments, changing the number of focal points (e.g., along with tissue depth 279) with respect to the ultrasound procedure can be advantageous in order to enable treatment of patients at various tissue depths, even when the focal depth 278 of the transducer 270 is fixed. This can result in synergistic effects and maximize the clinical outcome of a single treatment session. For example, treatment at multiple depths below a single surface area allows for tissue treatment of a larger total volume, thereby resulting in improved collagen formation and tightening. In addition, treatment at various depths affects various types of tissue, thereby generating various clinical effects that together lead to improved overall cosmetic results. For example, surface treatment can reduce the visibility of wrinkles, and treatment at deeper levels can induce the formation of more collagen proliferation. Similarly, treatment at various locations at the same or different depths can improve the treatment.

[0117] While treating a subject at different locations within a single session may be advantageous in some embodiments, sequential treatment over time may be beneficial in other embodiments. For example, a subject may receive treatment at a first depth at the first hour, at a second depth at the second hour, and so on, within the same surface region. In various embodiments, the time can be in nanoseconds, microseconds, milliseconds, seconds, minutes, hours, days, weeks, months, or other time periods. The new collagen generated by the first treatment may be more sensitive to subsequent treatments, which may be desirable for some indications. Alternatively, treatment at multiple depths within the same surface region within a single session may be advantageous because treatment at one depth may synergistically enhance or complement treatment at other depths (e.g., based on increased blood flow, growth factor stimulation, hormone enhancement, etc.). In some embodiments, multiple different transducer modules provide treatment at different depths. In one embodiment, a single transducer module can be adjusted or controlled for various depths. A safety feature to minimize the risk of selecting an incorrect depth is to choose to use it in conjunction with a single module system.

[0118] In some embodiments, methods are provided for treating the lower facial and neck regions (e.g., the subchinenchymal region). In some embodiments, methods are provided for treating (e.g., softening) the geniolabial folds. In other embodiments, methods are provided for treating the eye region (e.g., treating cheek pouches and suborbital sagging). Improvement of upper eyelid sagging, and improvement of periorbital lines and skin texture, can be achieved in some embodiments by treating at variable depths. By treating various locations in a single treatment session, optimal clinical effects (e.g., softening, tightening) can be obtained. In some 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.

[0119] In one embodiment, the transducer module 200 enables a treatment sequence at the skin surface or at a fixed depth below the skin surface. In one embodiment, the transducer module enables a treatment sequence at one, two, or more variable or fixed depths below the dermis. In some embodiments, the transducer module includes a drive mechanism adapted and / or configured to guide an ultrasonic treatment to form a sequence of multiple individual thermal injuries (hereinafter referred to as "thermal coagulation points" or "TCPs") at a fixed focal depth. In one embodiment, a sequence of individual TCPs has a processing interval ranging from approximately 0.01 mm to approximately 25 mm (e.g., 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 5 mm, 10 mm, 20 mm, and any value within this range), and dithering changes in intervals ranging from 1% to 50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, and any value within this range). For example, the interval can be 1.1 mm or less, 1.5 mm or more, approximately 1.1 mm to approximately 1.5 mm, etc. In one embodiment, the individual TCPs are discrete from each other. In one embodiment, the individual TCPs overlap each other. In one embodiment, the drive mechanism is adapted and / or configured to be programmable to provide a variable interval between the individual TCPs. In one embodiment, dithering can be adapted and / or configured to provide variable spacing between individual TCPs. In some embodiments, the transducer module includes a drive mechanism adapted and / or configured to guide the ultrasonic treatment to form a sequence such that TCPs can be formed in a linear or substantially linear sequence spaced apart from each other by the treatment distance. For example, the transducer module can be adapted and / or configured to form TCPs along a first linear sequence and along a second linear sequence spaced apart from the first linear sequence by the treatment distance. In one embodiment, the treatment distance between adjacent linear sequences consisting 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 consisting of individual TCPs is in the range of approximately 0.01 mm to approximately 50 mm. For example, the treatment distance can be 2 mm or less, 3 mm or less, approximately 2 mm to approximately 3 mm, etc. In some embodiments, the transducer module may include one or more drive mechanisms 400 adapted and / or configured to guide ultrasonic treatments to form sequences such that TCPs can be formed in linear or substantially linear sequences consisting of individual thermal damages spaced apart from other linear sequences by a treatment distance. In one embodiment, the treatment is applied in a first direction 290 (e.g., push). In one embodiment, the treatment is applied in the opposite direction to the first direction 290 (e.g., pull). In one embodiment, the treatment is applied in both the first direction 290 and the opposite direction to the first direction (e.g., push and pull). In one embodiment, the treatment distance separating linear or substantially linear TCP sequences is the same distance or substantially the same distance. In one embodiment, the treatment distance for separating linear or substantially linear TCP sequences is different or substantially different with respect to various adjacent pairs consisting of linear TCP sequences.

[0120] 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 to enable both ultrasound imaging and ultrasound treatment. In one embodiment, the transducer module is adapted and / or configured to enable treatment only. In one embodiment, the imaging transducer can be attached to the handle of a probe or hand wand. The first and second transducer modules are adapted and / or configured to allow interchangeable coupling to a hand wand. The first transducer module is adapted and / or configured to apply ultrasound treatment to a first layer of tissue, while the second transducer module is adapted and / or configured to apply ultrasound treatment to a second layer of tissue. The second layer of tissue is located at a different depth than the first layer of tissue.

[0121] As shown in Figure 3, in various embodiments, the delivery of emitted energy 50 at an appropriate focal depth 278, with an appropriate distribution, at the appropriate timing, and at an appropriate energy level is provided by the module 200 through controlled operation by the control system 300, thereby achieving the desired therapeutic effect of controlled thermal damage, which can treat at least one of the epidermal layer 502, dermal layer 503, adipose layer 505, SMAS layer 507, muscle layer 509, and / or subcutaneous tissue 504. Figure 3 shows one embodiment relating to depth corresponding to depth for treating muscle. In various embodiments, depth can correspond to any tissue, any tissue layer, any skin, any epidermis, any dermis, any subcutaneous tissue, any fat, any SMAS, any muscle, any blood vessel, any nerve, or any other tissue. During operation, the module 200 and / or transducer 280 can also be mechanically and / or electronically scanned along the surface 501 to treat an extended area. Before, during, and after the delivery of ultrasound energy 50 to at least one of the epidermal layer 502, dermal layer 503, subcutaneous tissue 504, adipose layer 505, SMAS layer 507, and / or muscle layer 509, the treatment area and surrounding structures can be monitored, allowing for planning, evaluation of monitoring results, and provision of feedback to the controller 300 and to the user via the graphical interface 310.

[0122] In one embodiment, the ultrasonic system 20 generates ultrasonic energy directed toward the surface 501 and focused below the surface 501. Such controlled and focused ultrasonic energy 50 generates thermal coagulation points or thermal coagulation zones (TCPs) 550. In one embodiment, the ultrasonic energy 50 generates voids within the subcutaneous tissue 510. In various embodiments, the emitted energy 50 targets the tissue below the surface 501 and cuts, cauterizes, coagulates, microcautes, manipulates, and / or generates TCPs 550 at a specified focal depth 278 within the tissue portion 10 below the surface 501. In one embodiment, during the treatment sequence, the transducer 280 moves in the direction indicated by an arrow labeled 290 at a specified interval 295, thereby generating a sequence of multiple treatment zones 254, each of which receives emitted energy 50 and generates one or more TCPs 550. In one embodiment, the arrow denoted by reference numeral 291 indicates an axis or orientation perpendicular or parallel to arrow 290, and the spacing of TCPs 550 indicates that the TCPs can be spaced perpendicular or parallel to the direction of movement of the transducer 280. In some embodiments, the orientation of the spaced TCPs can be set to any angle from 0 to 180 degrees from arrow 290. In some embodiments, the orientation of the spaced TCPs can be set to any angle from 0 to 180 degrees based on the orientation of the polarization region on the transducer 280.

[0123] 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), and may also include any other piezoelectrically active materials such as piezoelectric ceramics, crystals, plastics, composite materials, and lithium niobate, lead titanate, barium titanate, and lead metaniobate. In various embodiments, in addition to, or instead of, piezoelectrically active materials, the transducer module may include any other materials adapted and / or configured to generate radiant energy and / or acoustic energy. In various embodiments, the transducer module may be adapted and / or configured to operate at different frequencies and different depths of treatment. The characteristics of the transducer are the outer diameter ("OD") and the focal length (F). L ) can be defined by. In one embodiment, the converter has OD=19mm and F L In other embodiments, OD and F L Other appropriate values ​​can be used for this, for example, OD less than approximately 19 mm, OD greater than approximately 19 mm, etc., and F less than approximately 15 mm. L F, which is larger than approximately 15mm L, etc. can be used. The transducer module can be adapted and / or configured to apply ultrasonic energy to different target tissue depths. As described above, in some embodiments, the transducer module includes a drive mechanism adapted and / or configured to guide ultrasonic treatment to form a linear or substantially linear sequence of individual TCPs, such that there is a treatment interval between the individual TCPs. For example, the treatment interval may be about 1.1 mm, 1.5 mm, etc. In some embodiments, the transducer module may further include a drive mechanism adapted and / or configured to guide ultrasonic treatment to form a sequence such that TCPs can be formed in a linear or substantially linear sequence spaced apart by the treatment interval. For example, the transducer module can be adapted and / or configured to form TCPs along a first linear sequence and along a second linear sequence spaced about 2 mm to 3 mm apart from the first linear sequence by a treatment interval. In one embodiment, the user can manually drive the transducer module across the surface of the treatment area so that a plurality of adjacent linear sequences of TCPs can be generated. In one embodiment, the drive mechanism can automatically drive the transducer module across the surface of the treatment area so that a plurality of adjacent linear sequences consisting of TCPs can be generated.

[0124] Aperture space frequency analysis and Fourier transform In various embodiments, the efficiency of therapeutic procedures can be improved by using Fourier analysis and spatial frequency analysis techniques based on Fourier optics. When a system having 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 a convolution function as follows.

number

[0125] In various embodiments, the Fourier transform can be applied when calculating the convolution of equation (1). A continuous one-dimensional Fourier transform can be defined as follows:

number

[0126] In the equation, 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.

number

[0127] In various embodiments, the Fraunhofer approximation can be used to derive the relationship between a transducer 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 complex amplitude pattern produced by a complex aperture is equal to the two-dimensional Fourier transform of the aperture amplitude and phase. In some embodiments, this relationship in optics can be extended to ultrasound, because both light propagation and sound propagation can be described by using the linear wave equation. In the case of optics and / or ultrasound, the two-dimensional Fourier transform can determine the sound wave pressure amplitude distribution at the focus of the transducer.

[0128] In the case of a focused system, the variable z, which indicates depth, is the same as the variable z, which indicates focal length. f It can be replaced by this.

number

[0129] In various embodiments, Fourier optics and Fourier transform identities (some of which are listed in Table 1 below) can be used for ultrasonic transducers to determine the intensity distribution corresponding to the transducer design. For example, the Fourier transform of a rectangle rect(ax) is a sine function. As another example, the Fourier transform of a two-dimensional circle with uniform amplitude is a first-order Bessel function that can be represented as J1. [Table 1] Table 1

[0130] In some embodiments, the ultrasonic transducer may have a rectangular aperture having appropriate dimensions and focal length. In some embodiments, the ultrasonic transducer may have a circular aperture having appropriate dimensions and focal length. In one embodiment, the transducer may have a circular aperture having an outer diameter of approximately 9.5 mm, an inner diameter of approximately 2 mm, and a focal length of approximately 15 mm. The aperture of the circular transducer can be described as follows:

number

[0131] For example, in one embodiment, in equation (5a), the variable "a" can be approximately 9.5 mm, and the variable "b" can be approximately 2 mm. By applying a Fourier transform to equation (5a), an estimate of the sound wave pressure distribution at the focal point can be obtained.

number

[0132] In the formula, ξ x and ξ y This is the f in equations (4a) and (4b). x and f yThis is the same as the equation (6). Equation (6) shows that the sound pressure distribution of a transducer with a circular aperture is a first-order Bessel function. In one embodiment, substantially the majority of the energy is concentrated at the focal point (for example, 15 mm away from the aperture). The width of the main ultrasonic beam and the energy distribution away from the main beam can be expressed as a function of the operating frequency, as shown in equations (4a) and (4b).

[0133] In various embodiments, two identical or nearly identical beams can be generated at the focal point if the aperture is modulated (e.g., multiplied) by a suitable function. In one embodiment, a cosine function can be applied to a circular aperture as follows:

number

[0134] The energy distribution or beam response at the focal point of the modulated aperture in equation (7) is the convolution of the Fourier transforms of the two aperture functions.

number

[0135] Equation (8) can be simplified to the sum of two distinct functions by applying the Fourier transform identity for the Dirac delta function (for example, identity 2 in Table 2).

number

[0136] Equation (9) shows that the two beams appearing at the focal point are spatially shifted by ±c / (2π) compared to the original unmodulated beam. In some embodiments, the desired beam response can be obtained by using one or more other modulation functions, such as a sine function. In some embodiments, the aperture can be modulated so that three or more focal points are generated. For example, three, four, five, etc., focal points can be generated. In some embodiments, the aperture can be modulated so that the focal points are generated sequentially or substantially sequentially, rather than simultaneously.

[0137] In some embodiments, the therapeutic transducer module includes a drive mechanism configured to guide an ultrasonic procedure to form a linear or substantially linear sequence of individual TCPs, with treatment intervals between the individual TCPs. For example, the treatment interval may be about 1.1 mm, 1.5 mm, etc. In some embodiments, the transducer module may further include a drive mechanism configured to guide an ultrasonic procedure to form a sequence such that TCPs are formed in a linear or substantially linear sequence spaced apart by the treatment interval. For example, the transducer module may be configured to form TCPs along a first linear sequence and along a second linear sequence spaced about 2 mm to 3 mm apart from the first linear sequence by a treatment interval. According to equation (9), simultaneous or substantially simultaneous splitting in the ultrasonic beam can be obtained at the focal point (or in front of the focal point) when the aperture is modulated by a cosine and / or sine function of a desired spatial frequency. In one embodiment, two simultaneously or nearly simultaneously focused beams, spaced approximately 1.1 mm apart, can be generated in a linear or substantially linear sequence. At an ultrasonic frequency of 7 MHz, the wavelength λ of ultrasound in water is approximately 0.220 mm. Therefore, the spatial frequency ξ at the focal point is... x and ξ y It can be expressed as follows:

number

[0138] To position two foci separated by approximately 1.1 mm, the spatial frequency for modulating the aperture is 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 the following arguments.

number

[0139] In one embodiment, when the argument is 0, the equation (11a) is k x This can be solved.

number

[0140] Furthermore, x0 can be replaced by half of the separation distance (e.g., 1.1 mm).

number

[0141] In some embodiments, a transducer having a circular aperture that emits ultrasonic energy at various operating frequencies can be modulated by a sine function and / or cosine function at the spatial frequencies listed in Table 2. The modulated aperture of the transducer can generate simultaneously or substantially simultaneously split beams having two focal points with different separation distances, as shown in Table 2. In one embodiment, the transducer may have an OD of about 19 mm and a focal length of about 15 mm. [Table 2] Table 2

[0142] As shown in Table 2, in some embodiments, the spatial frequency of the aperture modulation function increases as the ultrasonic operating frequency increases with respect to a given focal separation distance. In addition, the spatial frequency increases as the desired focal separation distance increases.

[0143] In one embodiment, higher spatial frequencies can cause more rapid amplitude transitions within the aperture. Due to the processing limitations of the transducer, rapid amplitude changes within the aperture can reduce the efficiency of the aperture because there may be variations in the amount of sound pressure generated by different parts of the aperture. In one embodiment, using spatial frequencies to split the beam simultaneously or nearly simultaneously can reduce the overall focus gain of each beam. As shown in equation (9), the field pressure at the focus of each beam is reduced to half compared to the unmodulated beam. In one embodiment, increasing the sound pressure or ultrasonic intensity from the aperture can achieve a similar or substantially similar intensity at the focus plane. However, in one embodiment, increasing the pressure at the aperture may not be limited by the processing limitations of the system and / or transducer. In one embodiment, increasing the pressure at the aperture can increase the overall intensity in the near field, thereby increasing the possibility of overheating one or more treatment area tissues located in front of the focus. In one embodiment, the possibility of additional heating of one or more anterior focal tissues can be limited or eliminated by using a lower ultrasonic treatment frequency.

[0144] In one embodiment, two ultrasonic beams that are simultaneous or substantially simultaneous at the focal point can be generated by applying an aperture modulation function as shown in equation (7). In various embodiments, the ultrasonic beam can be divided into multiple passes, such as three, four, five, etc., so that multiple simultaneous or nearly simultaneous beams are generated. In one embodiment, four beams that are equally spaced along one dimension can be generated by modulating or multiplying the aperture by two distinct spatial frequencies.

number

[0145] As shown in equation (l2b), at the focal point, an unmodulated beam can be generated at four different positions along the x-axis. In one embodiment, a constant or DC term C1 can be added to the amplitude modulation function, thereby maintaining the energy distribution at the original focal position.

number

[0146] In one embodiment, aperture modulation of equations (12) and (13) that allows beams to be positioned simultaneously or nearly simultaneously at multiple locations may have limited applicability due to system limitations, material limitations, and / or tissue limitations. In one embodiment, the frequency of ultrasound therapy can be adjusted, for example, by lowering it, to limit and / or eliminate the possibility of heating of treatment area tissue located in front of the focal point. In one embodiment, a nonlinear technique can be applied to the focal point to limit and / or eliminate the possibility of heating one or more tissues in front of the focal point. In one embodiment, similar or substantially similar intensity can be obtained at the focal plane by increasing the sound pressure or ultrasound intensity from the aperture.

[0147] In various embodiments, when the amplitude and phase functions at the aperture are separable, the two-dimensional Fourier transform U(x1, y1) of the sound pressure function can be expressed as the product of one-dimensional Fourier transforms of two functions in x and y. In various embodiments, it may be advantageous to generate multiple TCPs in linear or substantially linear sequences, and to generate multiple linear sequences simultaneously or nearly simultaneously.

[0148] Electronic dithering of multiple beam splitting apertures using frequency modulation In various embodiments, Table 2 shows the aperture spatial frequencies for obtaining a specific distance between two simultaneous focal points with respect to a given operating frequency (e.g., 4 MHz, 7 MHz, 10 MHz in various embodiments). Equation (11c) shows that the distance between focal points is also a function of the operating frequency. For example, in one embodiment, the spatial frequency of the aperture (k x ) is 1.0mm -1 The operating frequency is fixed, but it can be varied. Equation 11c can be rewritten to show how the distance between the focal points can be modulated through the operating frequency.

number

[0149] In the formula, k x is, mm -1 This is a spatial frequency with units of z f This is the aperture depth of field in mm, and v c f is the speed of ultrasound in a propagation medium (e.g., water) in units of mm / μsec, and op This is the aperture operating frequency in MHz. In one embodiment, the following substitution is made in equation 11c.

number

[0150] As shown in equation (14), the distance between the focal points is a function of the operating frequency. Furthermore, the rate of change of the distance between the focal points with respect to the operating frequency is as follows:

number

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

[0152] As shown in Table 3, the focal points move closer together as the operating frequency increases and further apart as the operating frequency decreases, without the need to change the phase or mechanically move the transducer. This is a unique method that allows the beam to be electronically moved to spread energy without relying on heat conduction within the tissue. The advantages of this include reducing or minimizing the maximum temperature and increasing the thermal solidification volume made by the damage without requiring additional system channels.

[0153] The displacement from the primary operating frequency can be determined using equation (14). In one embodiment, the primary 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, Table 4 in Figure 5 shows the different spatial frequencies (k) when designed with respect to a center frequency of 5 MHz. x = 0.5 mm -1 , 1.0mm -1 , 1.5mm -1 , 2.0mm -1 This shows the amount of separation between focal points for an aperture having ). The amount of spread from the focal point at a center frequency of 5 MHz is also calculated. According to one embodiment, the spacing decreases for frequencies greater than 5 MHz and increases for frequencies less than 5 MHz.

[0154] Figure 6 shows the spacing difference for all operating frequencies of the apertures for different aperture spatial frequencies. As shown in Figure 6, the spacing increases as the frequency decreases.

[0155] In one embodiment, the separation distance is relative to a frequency of 5 MHz. In one embodiment, one method for estimating electronic dithering from frequency modulation can be determined by referring to all movement up to the initial separation at 5 MHz. As shown in Figure 7, the spread of the separation distance between the foci can easily vary beyond 1 mm.

[0156] In various embodiments, the range of possible operating frequencies from a single aperture can be described in terms of the transducer bandwidth. In one embodiment, a larger transducer bandwidth results in an aperture with a wider range of operating frequencies. The transducer bandwidth can be described as a percentage of the aperture center frequency by identifying the frequency at which the transmit strength decreases to -3 dB of the peak transmit strength. In one embodiment, with respect to the transmit response of the transducer aperture, the high frequency of -3 dB is f -3dB,H It is displayed as follows, and the low frequency of -3dB is f -3dB,L This is how it is displayed. The center frequency of -3dB in units of [MHz] is described as follows:

number

[0157] A bandwidth of -3dB percent is described as follows:

number

[0158] In some embodiments, an increase in the range of possible operating frequencies within a single aperture can be achieved 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 (shown below) shows how the focal spread can change based on a percentage of the bandwidth when the aperture center frequency is 5 MHz. The separation distance between focals at 5 MHz is 0.5 mm. -1 , 1.00mm -1 , 1.50mm -1 , 2.00mm -1 The spatial frequencies are 0.72 mm, 1.43 mm, 2.15 mm, and 2.86 mm, respectively. The spatial frequency at the aperture is 1.50 mm. -1 Furthermore, if the transducer bandwidth is 60%, the distance between the focal points changes by only 1.42 mm, which is a greater distance than the lateral resolution of the beam at 5 MHz. [Table 4] Table 5

[0159] In one embodiment, as the frequency is changed, the depth of field also changes, along with the lateral resolution and focus gain. In one embodiment, as the frequency is changed, the depth of field, lateral resolution, and focus gain also change. Therefore, in one embodiment, the intensity at the aperture can be changed according to the target heating rate. Also, in some embodiments, it may be advantageous to transmit multiple operating frequencies simultaneously to spread the energy immediately or almost immediately. For example, the transmitted excitation of the aperture may include excitations at 4 MHz, 5 MHz, and 6 MHz all at the same time.

[0160] Multiple focus points by changing the spatial frequency of the aperture As shown in Equation 14, the greater the spatial frequency of the aperture, the greater the distance between the focal points. In one embodiment, the aperture has a spatial frequency k x Polarization is performed by [the following]. As shown in the embodiment of Figure 8, the spatial frequency can be easily doubled or reduced to zero by connecting multiple individual electrical excitation channels that have the ability to change the phase to 0 degrees or 180 degrees. For example, when the phase of channels 1 to 16 is 0 degrees, the aperture spatial frequency is k x In one embodiment, when the phase of each channel changes from 0 to 180 degrees such that odd channels are at 0 degrees and even channels are at 180 degrees, the spatial frequency in the aperture is 1 / 2k x In one embodiment, if the phase repeats every two channels, such that channels 1 and 2 are 0 degrees, channels 3 and 4 are 180 degrees, 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, the spatial frequency at the aperture is 2k x In this case, seven unique focal points can be generated. As described in Table 4 (Figure 5), the aperture center frequency is 5 MHz and the aperture frequency is 0 mm. -1 , 0.5mm -1 , 1.0mm -1 , or 2.0 mm -1 In any of the above cases, the corresponding separation distances are 0 mm, 0.72 mm, 1.43 mm, and 2.86 mm, resulting in seven unique focal positions separated by only 0.36 mm. In various embodiments, intermediate phases between 0 and 180 degrees allow the two foci to be further tilted so that a line consisting of multiple foci can be generated at the focal plane. Ultimately, tilting, modulation of focal positions, and frequency modulation enable heating and possible solidification of the entire line having a length of approximately 2.86 mm.

[0161] In one embodiment, as shown in Figure 9, the polarization ceramic is 2k xIt has a spatial frequency of . In this case, each electrical channel covers two polarization regions within the ceramic (e.g., piezoelectric ceramic). If channels 1 to 8 have the same electrical phase to each other, the spatial frequency of the aperture is 2k x Therefore, if the phases are alternating, such that odd channels have a phase of 0 degrees and even channels have a phase of 180 degrees, the spatial frequency of the aperture is k x In one embodiment, this configuration, in which only two phases are possible on the channel, enables four unique focal points. In various embodiments, if additional phases are permissible, the two focal points can be tilted to many different focal positions. This configuration limits the number of electron channels required to obtain multiple focal positions.

[0162] In some embodiments, the treatment system utilizes multiple treatment channels to enable electronic focusing and / or steering. For example, a treatment system utilizing multiple treatment channels to enable electronic focusing and / or steering enables faster electronic dithering to produce more thermal coagulation using the same amount of energy as other treatment devices, or to produce equivalent thermal coagulation using electronic dithering with less energy than other treatment devices. This technique extends the continuity of effectiveness and comfort offered by the device. In addition to electronic dithering, multiple treatment channels also provide the possibility of moving the beam to different depth positions, so that two conventional transducers, such as the DS7-4.5 (7 MHz at a depth of 4.5 mm) and the DS7-3.0 (7 MHz at a depth of 3.0 mm), can be replaced by a single device that moves between two different depths.

[0163] In one embodiment, a transducer 280 (e.g., an annular array) having multiple treatment channels 281 connected to drive a beam axially typically generates TCP 550 first at deeper depths and then moves to shallower depths. In other embodiments, TCP 550 is generated at shallow depths below the skin surface and then at deeper depths. This results in the sequential generation of TCP 550 and an extended treatment time. For example, in one embodiment, time is allocated for the deeper TCP 550. deep , time for shallow TCP 550 shallow In this case, the total processing time for the two TCPs550 is the sum of the two processing times, i.e., t deep Plus T shallow In one embodiment, the total processing time is reduced by simultaneously forming multiple (two or more) TCPs550s using a signal mixing technique that employs both signal apodization (shading) and phase control in each channel. In one embodiment, the total processing time is t deep and t shallow It is the larger of the two values.

[0164] Treatment time, conventional approach: treatment =t deep +t shallow

[0165] Treatment time, signal mixing: t treatment =full(t deep ,t shallow )

[0166] In one embodiment, the annular array design 280 allows for electronic movement of the therapeutic beam in the depth direction (for example, by changing the depth of TCP550 below the skin surface). In one embodiment, the transducer 280 includes eight therapeutic channel annular transducer elements 281 having fixed mechanical focal points. Figure 10 shows a plan view of one embodiment of this ceramic annular array design 280 having an imaging transducer 285 at the center of the bowl. In this embodiment, the therapeutic annular transducer 280 has eight rings identified as Tx0 to Tx7 corresponding to the elements 281.

[0167] Converter In one embodiment, the transducer 280 is spherically focused to one or more points. In one embodiment, the transducer 280 is cylindrically focused to one or more lines. Various embodiments of the transducer 280 include a flat piezoelectric body having a lens. In various embodiments, the transducer 280 includes a convex surface 282 and a concave surface 283. In various embodiments, the transducer 280 includes a convex surface 282 and a concave surface 283 having one, two, three, four, or more simultaneous focus zones, characterized by providing any one or more variable depths, variable spacings, and variable focus positioning. In various embodiments, the transducer 280 is electrically connected to one or more tuning circuits. The tuning circuits improve the electrical signal between the console and the transducer. In various embodiments, one or more tuning circuits are located within the housing of the transducer and / or within the connection portion between the transducer and the console and / or within the console.

[0168] Figure 11 shows one embodiment of a transducer 280 comprising a single element having a convex surface 282 and a concave surface 283. Figure 12 shows one embodiment of a transducer 280 comprising a smoothly coated convex surface 282 and a striped concave surface 283, wherein the stripe comprises a first polarization region and a second polarization region, and the polarization region is positively polarized, negatively polarized, or unpolarized. Figure 12 shows one embodiment of a transducer 280 comprising a smoothly coated convex surface 282 and a striped concave surface 283, wherein the stripe comprises a first region and a second region, and the region may or may not include a coating. In one embodiment, a single electrode is provided on the convex surface, and the polarization stripe on the concave surface is connected to two channels (e.g., Figure 12). The stripe may be alternating so as to be able to split the beam, or it may contain only one phase so as to mimic a conventional transducer. This makes it possible to simulate the procedures of DS4-4.5S and DS4-4.5 with a single converter, thereby enabling the generation of three lines with the arrangement of a single converter.

[0169] Figure 13 shows one embodiment of a transducer 280 including a striped convex surface 282 and a smooth coated concave surface 283, wherein the stripe includes a first polarization region and a second polarization region, and the polarization region is positively polarized, negatively polarized, or unpolarized. Figure 13 shows one embodiment of a transducer 280 including a striped convex surface 282 and a smooth coated concave surface 283, wherein the stripe includes a first region and a second region, and the region may or may not include a coating. In various embodiments, the stripe is electrically connected to one or more channels. In one embodiment, odd-numbered stripes are connected to the first channel and even-numbered stripes are connected to the second channel. In one embodiment, the first channel is kept at 0°, while the second channel is alternating between 0° and 180° (or conversely, the first channel is alternating between 0° and 180°, while the second channel is kept at 0°). The focused ultrasonic energy from the first channel remains at a single central position, while the focused ultrasonic energy from the second (alternating) channel generates two spaced-apart focal zones. Together, the focused ultrasonic energy from the first (constant) channel and the second (alternating) channel generates three simultaneous TCPs. In one embodiment, a single electrode is provided on a concave surface, and a polarization stripe on a convex surface is connected to the two channels (e.g., Figure 13). The stripe can be alternating to split the beam, or it can contain only one phase to mimic a conventional transducer. This makes it possible to mimic the treatments of DS4-4.5S and DS4-4.5 with a single transducer, thereby enabling the generation of three lines with a single transducer configuration.

[0170] Figure 14 shows one embodiment of a transducer 280 including a striped convex surface 282 and a striped concave surface 283, wherein the stripes include a first polarization region and a second polarization region, and the polarization regions are positively polarized, negatively polarized, or unpolarized, and the striped regions are rotated approximately 90 degrees relative to each other. Figure 14 shows one embodiment of a transducer 280 including a striped convex surface 282 and a smooth coated concave surface 283, wherein the stripes include a first region and a second region, and the regions may or may not include a coating, and the stripes are rotated approximately 90 degrees relative to each other.

[0171] Figure 15 shows one embodiment of a transducer 280 including a striped convex surface 282 and an annular concave surface 283, wherein the stripe includes a first polarization region and a second polarization region, and the polarization region is positively polarized, negatively polarized, or unpolarized. Figure 15 shows one embodiment of a transducer 280 including a striped convex surface 282 and an annular concave surface 283, wherein the stripe includes a first region and a second region, and the region may or may not include a coating.

[0172] Figure 16 shows one embodiment of a transducer 280 including an annular convex surface 282 and a striped concave surface 283, wherein the stripe includes a first polarization region and a second polarization region, and the polarization region is positively polarized, negatively polarized, or unpolarized. Figure 16 shows one embodiment of a transducer 280 including an annular convex surface 282 and a striped concave surface 283, wherein the stripe includes a first region and a second region, and the region may or may not include a coating.

[0173] In some embodiments, the system includes various features that exist as a single feature (as opposed to multiple features). For example, in one embodiment, the system includes, or substantially consists of, a single ultrasonic converter configured to provide two simultaneous treatment zones via dithering. In alternative embodiments, multiple features or multiple components are provided.

[0174] Simultaneous treatment at multiple depths In various embodiments, the treatment system is configured to generate multiple microcoagulation regions within the tissue, spaced equidistant along a line of mechanical movement. In various embodiments, the treatment system provides various modules, or various cartridges, or various 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 this device is a slim transducer used in hard-to-reach locations such as around the nose and mouth. The first four transducers can deliver treatment along a 25 mm line, while the slim transducers offer a maximum line length of 14 mm). In various embodiments, a transducer having an annular electrode and a polarization ceramic enables frequency dithering in the lateral dimension, electronic dithering in the depth dimension, electronic focusing in the depth dimension, and a single transducer capable of mimicking DS10-1.5 (10 MHz at a depth of 1.5 mm), DS7-3.0 (7 MHz at a depth of 3.0 mm), DS7-4.5 (7 MHz at a depth of 4.5 mm), and DS4-4.5 (4 MHz at a depth of 4.5 mm). In one embodiment, selectable tuning electronics can be used in combination with the composite ceramic, thereby enabling the functions of the transducer having an annular electrode and a polarization ceramic, which include 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 selectable tuning circuits may be present to assist in stabilizing the signal between the console and the converter, and may be located within the converter housing, between the converter and the console, or within the console.

[0175] In one embodiment, during a full-face treatment, the operator moves the handpiece along the patient's skin for approximately 70 to 90 minutes, with the transducer delivering 800 treatment lines. 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 trials, can reduce treatment delivery time by approximately 40%. In various embodiments, the treatment device provides equivalent levels of efficacy when operated with appropriate energy. In various embodiments, simultaneous treatment reduces the overall pain of the treatment. In one embodiment, simultaneous treatment time is significantly reduced, and overall pain of the treatment is assumed to be lower.

[0176] In various embodiments, simultaneous treatment increases the treatment speed by 10%, 20%, 25%, 30%, 40%, 50%, 60%, or more. In various embodiments, simultaneous treatment reduces the treatment time by 10%, 20%, 25%, 30%, 40%, 50%, 60%, or more. In various embodiments, the system is configured to complete the treatment in 60 minutes, 50 minutes, 40 minutes, 30 minutes, 20 minutes, or 10 minutes, or less.

[0177] In one embodiment, the simultaneous treatment system generates two lines simultaneously while having the ability to move the depth of microcoagulation in the thermal coagulation zone 550. In one embodiment, the bandwidth of the therapeutic transducer is increased, thereby enabling one device to operate like two, three, four, five, or six fixed-depth devices. In one embodiment, an 8-channel therapeutic device is used.

[0178] Figure 17 shows one embodiment of a transducer 280 including an annular convex surface 282 and a striped concave surface 283, the stripe including a first polarization region and a second polarization region, the polarization region being positively polarized, negatively polarized, or unpolarized. Figure 17 shows one embodiment of a transducer 280 including an annular convex surface 282 and a striped concave surface 283, the stripe including a first region and a second region, the region may or may not include a coating. In one embodiment, an annular array coupled to a simultaneous transducer delivers focused ultrasonic treatment in two lines below the skin surface at different depths 279 (e.g., D1, D2, D3, ...D NThis allows for simultaneous generation at the ). In one embodiment, the stripes on the concave surface 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 any range within the following ranges: 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, 0.5 mm to 5 mm, 1.5 mm to 4.5 mm, greater than 4.5 mm, greater than 6 mm, 7 mm, and any range within the following ranges: 0.1 mm to 3 mm, 0.1 mm to 4.5 mm, 0.1 mm to 25 mm, 0.1 mm to 100 mm, as well as any depth within these ranges (e.g., 6 mm, 7 mm, 10 mm, 13 mm, 15 mm, 17 mm). In one embodiment, simultaneous treatment at multiple depths generates multiple thermal solidification zones 550 at various depths 279. Figure 17 shows two faces in one embodiment of the simultaneous treatment bowl. On one face of the treatment bowl is a stripe used to perform alternating polarization. In one embodiment, the stripe is on a concave surface 283. In one embodiment, the stripes are located on the convex surface 282. In one embodiment, after polarization, the electrodes are removed and a complete electrode is placed across the entire surface. In one embodiment, the stripes can also be connected by using cold silver electrodes. In one embodiment, the opposite surface of the treatment bowl includes a plurality of concentric rings, some having equal areas and others having unequal areas. The annular array allows beam movement in the depth direction when proper phase adjustment is applied to the treatment bowl.

[0179] In one embodiment, a transducer 280 having an annular convex surface 282 and a striped concave surface 283 is configured to generate multiple thermal solidification zones 550 at various depths 279, as shown in Figure 18 (projection in xyz space), Figure 19 (xz plane), and Figure 20 (yz plane). Figure 18 shows a three-dimensional sketch of a microsolidification point. In one embodiment, two, three, four, or more points can be generated simultaneously. In one embodiment, two points are generated simultaneously. In one embodiment, it is assumed that deeper microsolidification points are generated first (e.g., 4.5 mm), then move to the next depth (e.g., 3.0 mm), and then move to the shallowest depth (e.g., 1.5 mm). In one embodiment, the drive mechanism moves from left to right and from right to left. In one embodiment, skin temperature can be limited by forming microcoagulation points at the deepest depth (e.g., 4.5 mm) as the device moves from left to right, then by positioning them at the next depth (e.g., 3.0 mm) as the device moves from right to left, and finally by completing the treatment with microcoagulation points at the shallowest depth (e.g., 1.5 mm) as the device moves again from left to right. Figure 19 shows projections of the treatment along the mechanical movement direction (x-axis) and depth direction (z-axis). Figure 20 shows projections of the treatment along the direction in which the beam is split (y-axis) and depth direction (z-axis).

[0180] Figures 21-23 show one embodiment of a simultaneous multi-depth treatment device configured to generate TCPs at depths of 1.5 mm, 3.0 mm, and 4.5 mm, with the intermediate layers offset from the deeper and shallower depths. In one embodiment, a transducer 280 having an annular convex surface 282 and a striped concave surface 283 is configured to generate multiple depth thermal solidification zones 550 at various depths 279, as shown in Figure 21 (projection in xyz space), Figure 22 (xz plane), and Figure 23 (yz plane). In one embodiment, the length of the TCP may limit the ability to directly stack the multiple depth TCPs on top of each other. In one embodiment, a drive mechanism offsets the treatment of TCPs at different depths from each other. Figure 21 shows a three-dimensional view of an offset multi-depth transducer. A delivery process similar to that described in Figures 18-20 can be applied to the embodiments in Figures 21-23, where the microcoagulation points can be delivered while moving from left to right or from right to left, thereby minimizing any potential damage to the epidermal, dermal, or tissue layers. Figure 22 shows the projection of delivery along mechanical movement (x-axis) and depth (z-axis). This clearly shows that the intermediate layers of TCPs are offset from the deep and shallow treatments. Figure 23 shows the projection of delivery along the direction in which the beam is split (y-axis) and along the depth direction (z-axis).

[0181] Figures 24-26 show one embodiment of a simultaneous multi-depth treatment device configured to generate TCPs at depths of 1.5 mm, 3.0 mm, and 4.5 mm, with the intermediate layer offset from the shallower depths by a variable pitch. In one embodiment, the spacing between TCPs in a single-line treatment can be matched by using a drive mechanism. Figures 24-26 show three-dimensional sketches of simultaneous treatment at multiple depths. In this embodiment, treatment at a depth of 4.5 mm is delivered at a certain pitch (spacing of 1.5 mm), while treatment at a depth of 3.0 mm and treatment at a depth of 1.5 mm are delivered at other pitches (e.g., spacing of 1.1 mm). Although the treatment at 1.5 mm depth and treatment at 3.0 mm depth have the same pitch (e.g., 1.1 mm), an offset can be applied by the drive mechanism, thereby preventing the stacking of micro-solidification points. Figure 25 shows the projection of delivery along mechanical movement (x-axis) and depth (z-axis). This clearly shows that the intermediate layers of TCPs are offset from the shallower treatments, even if the pitch is the same. Similarly, the deepest treatment has a slightly larger pitch compared to the other two depths. Figure 26 shows the projection of delivery along the direction in which the beam is split (y-axis) and along the depth direction (z-axis).

[0182] In various embodiments, a transducer 280 having an annular convex surface 282 and a striped concave surface 283 (as shown in Figures 16 and / or 17) generates the treatment patterns shown in the embodiments of Figures 25, 26, and / or 29. In one embodiment, the transducer 280 having an annular convex surface 282 and a striped concave surface 283 generates an intensity peak near the center of the focal zone when viewed in a projection in xyz space (as in Figures 18 and 19), where the control of each ring within the annular convex surface 282 has amplitude (A) and phase (θ). In this case, the polarization based on the stripes generates multiple simultaneous foci at one depth. As shown in Figures 18 and 19, different phases (θ) and different amplitudes (A) can be applied to each ring for the purpose of generating multiple simultaneous foci at each depth, thereby generating multiple simultaneous foci at different depths. Different phases allow the two foci to move to different depths of focus, and different amplitudes allow for changes in the heating rate within the tissue by changing the focal intensity. The amount of separation along the Y-axis between two foci at the same depth is determined by the frequency, the depth of focus, and the spatial frequency of the stripe (see Equation 14 when solved for s). The transducer can be driven manually or mechanically, thereby precisely separating the simultaneous foci along the X-axis. In one embodiment, the amplitude A1 of the intermediate ring is greater than the amplitude A2 of the next outer ring, amplitude A2 is greater than amplitude A3, ..., up to the amplitude A of the outermost ring. n This larger amplitude results in a wider intensity range and the ability to shape two simultaneously occurring foci. This control of amplitude allows for changing the beam width at the two foci, as well as changing the intensity which affects the heating rate.

[0183] In various embodiments, by using a continuous wave function, excitation functions for the focal solution method can be combined with other solution methods to generate simultaneous focal zones at different depths below the skin surface. In one embodiment, a focal zone (f1) at a first depth (d1) is generated simultaneously with a second focal zone (f2) at a second depth (d2) different from the first depth (d1). Both foci at different depths (d1 and d2) can be generated simultaneously via a linear system combining excitations for a single ultrasonic converter. The following table shows the two sets of amplitudes and phases required for each focal zone and depth. Two excitations on each ring can be combined for one amplitude and one phase so that these two excitations occur at the same frequency. Assume that the excitation on ring number 1 for focal #1 is described as follows:

number

[0184] Assume that the excitation on ring number 1 for focus #2 is described as follows:

number

[0185] In the equation, ω is 2πf, where f is frequency and t is time. [Table 5] To simultaneously generate two foci at two different depths, two excitations must be combined for the first ring.

number

[0186] However, even if this is the necessary excitation on ring 1, the actual amplitude and phase required on the ring to properly excite both f1 and f2 simultaneously are unknown. To determine this new amplitude (Λ1) and new phase (Ω1) for the combined effect, the following trigonometric identity is applied.

number

[0187] Therefore, the new excitations on ring 1 are as follows:

number

[0188] By applying the same process to other rings, we can obtain an array solution that simultaneously generates f1 and f2. Similarly, if it is desired to deliver three or more foci simultaneously, the process can be repeated using the above identity until only one excitation and one phase are calculated for each ring. For example, assuming the goal is to generate three foci simultaneously, the initial new amplitude and new phase for each ring are calculated based on the amplitude and phase required for foci 1 and foci 2. These new amplitudes and phases are then combined with the ring excitation required for focal 3.

[0189] Although it is possible to generate multiple simultaneous foci using this methodology, the required amplitude may be limited by the saturation of the piezoelectric material and by the tissue's ability to absorb the increased intensity in the surrounding tissue when generating multiple foci. These physical limitations must be weighed against the temporal advantage of generating multiple foci simultaneously.

[0190] Figures 27-29 illustrate an embodiment of a simultaneous multiple depth treatment device configured to generate TCPs at depths of 1.5 mm, 3.0 mm, and 4.5 mm. The intermediate layer is offset from the shallow depth, and the frequency is used to generate different separation distances at each depth. In FIGS. 24-26, the intermediate depth of the TCPs is offset from the deepest depth and from the shallowest depth using a drive mechanism. In various embodiments, the amount of separation between simultaneously generated TCPs depends on the treatment frequency. In one embodiment, the device can deliver treatment at multiple frequencies (e.g., using a broadband therapy transducer) and can modulate the distance between TCPs using the frequency. As described with respect to FIG. 18, the stripe spacing is determined during manufacture because it is generated through ceramic polarization. Smaller frequencies and deeper depths result in a wider separation (y-z plane) between simultaneously generated TCPs. FIG. 4a shows a three-dimensional matrix of TCPs with this variable degree of separation. As the frequency increases for shallower depths and as the depth of treatment decreases, the distance between simultaneously generated TCPs decreases. FIG. 28 shows a projection of delivery along the mechanical movement (x-axis) and depth (z-axis). This clearly shows that the intermediate layer of TCPs is offset from shallow treatments and from deep treatments, even if the pitch is the same. FIG. 29 shows a projection of delivery along the direction (y-axis) in which the beam is split and along the depth direction (z-axis). This projection shows that as the depth of treatment increases, mainly due to changes in depth and frequency in the treatment, the spacing between TCPs gradually increases.

[0191] In one embodiment, as shown in FIG. 29, different separations can be generated by changing the frequency and focal depth. For example, Equation 14 is as follows.

[0192]

Equation

[0193] In the formula, s is the distance between two simultaneous foci at the same depth. This formula shows that the separation between the foci is a function of the depth of focus (z f ) and the frequency (since λ is the speed of sound divided by the frequency). Assume that the same frequency and the same spatial frequency are used on the stripe. The following table summarizes the separations for different foci separated by 1.5 mm.

Table 6

[0194] However, if the frequency is changed so that a larger frequency is used for the shallowest focus, a fairly wide range of separation distances can be obtained.

Table 7

[0195] In various embodiments, by using different w (e.g., w1, w2), the distance or interval can be changed. In various embodiments, by using a continuous wave function, a plurality of focus zones can be simultaneously generated at different depths below the skin surface while combining the frequency with Fourier transform. In one embodiment, the focus zone (f1) at the first depth (d1) is simultaneously generated with the second focus zone (f2) at a second depth (d2) different from the first depth (d1). Both foci at different depths (d1 and d2) can be simultaneously generated via a linear system that combines excitations for a single ultrasonic transducer element.

Table 8

[0196] In various embodiments, when a sufficient DC bias is applied to the material, the electrostrictive element exhibits piezoelectric behavior. In one embodiment, the intensity of the piezoelectric behavior is proportional to the acoustic sensitivity. In one embodiment, the electrostrictive material is used together with a treatment bowl in the manufacturing process. In one embodiment, pattern formation and electrode mounting are performed during manufacturing, but the polarization of the electrostrictive element is performed during treatment delivery. For example, in one embodiment, the delivery aperture can be a square wave, as shown in Figure 37, or it can be shaded by changing the high voltage value. Figure 30 shows one embodiment of a simultaneous multi-depth treatment device configured to generate TCPs at depths of 1.5 mm, 3.0 mm, and 4.5 mm, with an annular array coupled with electrostrictive elements capable of simultaneously generating multiple pairs at different depths. In one embodiment, the electrostrictive element can change its spatial frequency (as shown in one embodiment, for example, in Figure 37), thereby generating treatment lines (as shown in one embodiment, for example, in Figure 34). In one embodiment, the electrostrictive element generates treatment lines without using a mechanical drive mechanism. In one embodiment, the electrostrictive element generates a line perpendicular to the movement of the mechanical drive mechanism. Thus, in various embodiments, treatment in multiple dimensions can generate one, two, or more treatment focus zones at various intervals, in various lines, in various planes, or in various three-dimensional spaces. In some embodiments, the electrostrictive element, when exposed to an external electric field, causes ion displacement within the crystal lattice of the piezoelectric transducer. In various embodiments, Figures 17 to 29 have a fixed polarization pattern to create a separation distance between two simultaneously generated TCPs. This is because the polarization pattern is generated within the piezoelectric ceramic during manufacturing. The spacing between the stripes determines the spacing between the TCPs. The greater the distance between the stripes, the closer the TCPs will be. In some embodiments, there is no ability to change the distance between the stripes after polarization is complete.In one embodiment, as shown in Figures 30 to 33, although the electrostrictive material does not contain polarization, an electrostrictive element can be used to apply a direct current (DC) voltage during device operation, thereby exhibiting piezoelectric behavior that can be used to improve the device's performance. Figure Sa shows the front and back surfaces (e.g., concave and convex) of a ceramic bowl similar to the embodiment shown in Figure 17. In one embodiment, the annular pattern is on the back surface (e.g., convex) of the transducer. The front surface (patient side, e.g., concave) is slightly different compared to the embodiment in Figure 17, for example, the stripes appear to be produced at a finer pitch. Secondly, although the ceramic is not polarized, connections from individual stripes can be made to individual banks of electronic equipment, and a voltage can be applied across the stripes, thereby generating a suitable pattern that results in a separation distance between TCPs. In one embodiment, the voltage changes at high spatial frequencies, resulting in a larger separation distance between TCPs. The electronic equipment is made capable of changing this pattern so that the distance between TCPs can also be changed. As a result, simultaneous TCPs that can be generated through this amplitude modulation are collected. It is not necessary to apply a negative or positive voltage on each stripe. In some embodiments, acoustic excitation is prevented or reduced by grounding the stripe. Figure 31 shows one embodiment of a type of TCPs distribution that can be generated three-dimensionally. In one embodiment, five TCPs are generated at each depth, which are obtained by three different DC amplitude modulation patterns on the stripe. In this case as well, the order can be changed within depth 279 or at each depth based on the movement of the drive mechanism from left to right or right to left, based on the modulation pattern, and based on the focusing of the ring. The order used is based on the safety tolerance of the epidermis, dermis, and other tissue layers, and the goal of delivering TCPs as quickly as possible. Figure 32 shows the projection of delivery along mechanical movement (x axis) and depth (z axis). Figure 33 shows the projection of delivery along the direction in which the beam is split (y axis) and along the depth direction (z axis).This projection shows five TCPs generated within this plane. Two pairs of TCPs are generated simultaneously, while one pair is generated at once, similar to conventional transducers. In various embodiments, the techniques described with respect to the embodiments in Figures 21 to 29 are applicable to the design of electrostrictive elements.

[0197] Figures 34-36 illustrate one embodiment of a simultaneous multi-depth treatment device configured to generate TCPs at depths of 1.5 mm, 3.0 mm, and 4.5 mm, where an annular array coupled to the simultaneous treatment transducer enables the simultaneous generation of two lines at different depths. In one embodiment, the advantage of using an electrostrictive element with sufficient stripes is the ability to generate heating lines for treatment when the pattern changes rapidly. Figure 34 illustrates an embodiment showing a three-dimensional TCPs line generated using multiple spatial frequencies related to the electrostrictive element pattern at only one depth. Depending on the rate of change of the pattern across the entire stripe, this heating can be modified to generate lines of microcoagulation, or high-temperature lines to represent tissue of cell apoptosis. Figure 35 shows a projection onto the xz plane to illustrate five lines. Figure 36 shows a projection onto the yz plane, which shows heating lines along the y axis at specific depths.

[0198] In one embodiment, Figure 37 shows different patterns that can be generated when the stripe has a fine pitch. In Figure 37, the X-axis represents the distance across the transducer. The Y-axis represents the amplitude of the DC at a position across the transducer. Various DC signals applied across the transducer can result in different spacings between focal points in various embodiments. In one embodiment, the fine pitch is related to the division distance, operating frequency, and depth of focus to be obtained. In various embodiments, the fine pitch is 0.1 mm to 0.05 mm (e.g., 100 microns to 50 microns, including 90 microns, 80 microns, 70 microns, and 60 microns, and any value within this range). This figure shows amplitude modulation that can result in various spacings of microcoagulation points along the Y-axis. Although this figure covers factors of multiples of 2, other modulation patterns can be located between the illustrated multiples. The modulation pattern does not have to be an integer of 1 × pattern. In various embodiments, even, odd, and null patterns are possible. Finally, electrostrictive methods also offer the possibility of modulating the amplitude pattern because polarization is a strong function of the DC bias.

[0199] Various advantages of embodiments of a simultaneous multi-depth treatment device configured to generate multiple TCPs at various depths include the simultaneous generation of TCPs at multiple depths. In one embodiment, the advantage is the elimination of the need for multiple transducers, thereby reducing the need for the operator to change transducers. In one embodiment, the advantage is faster treatment time. In one embodiment, the advantage is the delivery of the same number of lines with fewer button presses. In one embodiment, the advantage is the modulation of the distance between simultaneously delivered TCPs. In one embodiment, the advantage is the maintenance of pitch spacing between TCPs at each depth along the mechanical movement line. In one embodiment, the advantage is the avoidance of pulse stacking at multiple depths. In one embodiment, the advantage is the ability to generate larger zones related to coagulation and apoptosis. In one embodiment, the advantage is the ability to deliver microcoagulation lines along three dimensions. In one embodiment, the advantage of using an electrostrictive element includes generating three or more lines by placing one transducer in the patient's body. In one embodiment, the advantage of using an electrostrictive element is the modulation of the distance between simultaneously delivered TCPs. In one embodiment, the advantage is the ability to modulate the spatial high-frequency harmonics from the simultaneous therapeutic modulation pattern. In one embodiment, the advantage of using an electrostrictive element is that it provides the possibility of adding nulls to the modulation pattern. [Examples]

[0200] The following examples are non-limiting embodiments.

[0201] In some embodiments, an ultrasonic treatment system is provided for generating multiple focal points at different depths using a single ultrasonic transducer, comprising an ultrasonic probe with an ultrasonic transducer configured to apply ultrasonic treatment to tissue at multiple locations having at least two focal depths by at least one of the group consisting of amplitude modulation polarization and phase shift, and a drive mechanism configured to be programmable to provide spacing between multiple individual cosmetic treatment zones, the sequence of multiple individual cosmetic treatment zones having treatment intervals in the range of 1 mm to 50 mm, and a control module coupled to the ultrasonic probe for controlling the ultrasonic transducer, wherein the ultrasonic transducer is configured to provide an acoustic output for ultrasonic treatment in the range of 10 W to 1000 W and a frequency of 1 MHz to 20 MHz, so as to be able to thermally heat the tissue and induce coagulation. The multiple locations can be arranged in a substantially linear sequence within the cosmetic treatment zones, and the ultrasonic transducer comprises a single ultrasonic transducer element. In one embodiment, a first set of positions is located within a first cosmetic treatment zone, and a second set of positions is located within a second cosmetic treatment zone, wherein the first zone is distinct from the second zone. The first cosmetic treatment zone may include a substantially linear sequence of the first set of positions, and the second cosmetic treatment zone may include a substantially linear sequence of the second set of positions.

[0202] In one embodiment, the ultrasonic transducer is configured to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic therapy phase shift, in which case multiple parts of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple phases of acoustic intensity, 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, in which case multiple parts of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude, and further configured to apply ultrasonic therapy phase shift, in which case multiple parts of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase. The multiple phases may include discrete phase values. The ultrasonic transducer may include a piezoelectric material, and multiple parts of the ultrasonic transducer may be configured to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the multiple changes in the piezoelectric material include at least one of expansion and contraction of the piezoelectric material. The ultrasonic treatment system may have at least a portion of an ultrasonic transducer configured to emit ultrasonic treatment at two or more amplitudes of acoustic intensity, the amplitude of the ultrasonic treatment emitted by at least a portion of the piezoelectric material changes over time. In one embodiment, the drive mechanism is configured to be programmable to provide variable spacing between a plurality of individual cosmetic treatment zones and further includes one or more selectable tuning circuits. The ultrasonic treatment system may include a sequence of a plurality of individual cosmetic treatment zones having treatment intervals ranging from 1 mm to 25 mm and further includes tuning circuits.In one embodiment, the ultrasound treatment is at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, skin tightening, venous reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, cellulite treatment, décolletage treatment, vaginal rejuvenation, and acne treatment. The ultrasound treatment system may include an ultrasound transducer configured to provide an acoustic output for ultrasound treatment ranging from 10W to 100W and a frequency of 1MHz to 12MHz in order to thermally heat the tissue and induce coagulation.

[0203] In some embodiments, a treatment system is provided for generating multiple focal points simultaneously at different depths using a single ultrasonic transducer, the system comprising: an ultrasonic probe including a first switch for operably controlling an ultrasonic imaging function to provide ultrasonic imaging; a second switch for operably controlling an ultrasonic treatment function to provide ultrasonic treatment; and a drive mechanism configured to guide ultrasonic treatment to form at least one sequence of multiple individual thermal cosmetic treatment zones; a transducer module configured to apply ultrasonic treatment by at least one of the group consisting of amplitude modulation polarization and phase shift, configured to perform both ultrasonic imaging and ultrasonic treatment, configured to be coupled to the ultrasonic probe, and configured to apply ultrasonic treatment to tissue at multiple locations having at least two focal depths, and configured to be operably coupled to at least one of the first switch, the second switch and the drive mechanism; and a control module including a processor and a display for controlling the transducer module. In one embodiment, the ultrasonic treatment is a cosmetic treatment, and the multiple locations are arranged in a substantially linear sequence within the cosmetic treatment zone. The treatment system may include an aesthetic treatment called an ultrasound treatment, wherein a first set of multiple locations is located within a first treatment zone, and a second set of multiple locations is located within a second treatment zone, the first zone being distinct from the second zone. In one embodiment, the first treatment zone includes a substantially linear sequence of the first set of multiple locations, and the second treatment zone includes a substantially linear sequence of the second set of multiple locations. The transducer module may be configured to apply ultrasound treatment using amplitude modulation, in which case multiple parts of the transducer module are configured to emit ultrasound treatment at multiple amplitudes of acoustic intensity, the first amplitude being distinct from the second amplitude.In one embodiment, the transducer module is configured to apply an ultrasonic therapy phase shift, in which case multiple parts of the transducer module are configured to emit ultrasonic therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase. The transducer module can be configured to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the transducer module are configured to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. Furthermore, it can be configured to apply an ultrasonic therapy phase shift, in which case multiple parts of the transducer module are configured to emit ultrasonic therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase. In one embodiment, the multiple phases include discrete phase values. The transducer module may include a piezoelectric material, and multiple parts of the transducer module are configured to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the transducer module. In one embodiment, the plurality of changes in the piezoelectric material include at least one of expansion of the material and contraction of the material. The treatment system may include at least a portion of a transducer module configured to emit ultrasonic treatment at two or more amplitudes of acoustic intensity, wherein the amplitude of the ultrasonic treatment emitted by at least a portion of the transducer module changes over time. In one embodiment, the drive mechanism is configured to be programmable to provide variable spacing between a plurality of individual thermal cosmetic treatment zones. The treatment system may include a sequence of a plurality of individual thermal cosmetic treatment zones having treatment intervals ranging from 1 mm to 25 mm. In one embodiment, the first and second switches include buttons or keys operated by the user. The treatment system may include at least one first and second switch activated by a control module.In one embodiment, the function of the treatment is at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, cellulite treatment, décolletage treatment, vaginal rejuvenation, and acne treatment. The transducer module can be configured to provide an acoustic output for ultrasound treatment ranging from 10W to 1000W and a frequency of 1MHz to 20MHz in order to thermally heat the tissue and induce coagulation.

[0204] In some embodiments, a treatment system for delivering simultaneous treatment at multiple depths includes a control device that operably controls an ultrasound treatment function to provide ultrasound treatment, and a hand wand configured to guide ultrasound treatment to form a sequence of multiple individual thermal cosmetic treatment zones, the hand wand including a transducer configured to apply ultrasound treatment to tissue at a location at the focal depth, the transducer further configured to simultaneously apply ultrasound treatment to tissue at multiple locations at the focal depth.

[0205] In some embodiments, a method for performing a non-invasive cosmetic procedure on the skin by generating multiple simultaneous foci at multiple depths with a single transducer, the method comprising coupling a transducer module to an ultrasonic probe, wherein the ultrasonic probe includes a first switch for controlling acoustic imaging, a second switch for controlling acoustic therapy to cause a plurality of individual cosmetic treatment zones, and a drive mechanism for providing a desired spacing between the plurality of individual cosmetic treatment zones; coupling the transducer module to the ultrasonic probe; contacting the transducer module with the skin surface of a subject; acoustically imaging a region below the skin surface by the transducer module by activating the first switch on the ultrasonic probe; and acoustically treating a region below the skin surface by the transducer module with a desired sequence of a plurality of individual cosmetic treatment zones controlled by the drive mechanism by activating the second switch of the ultrasonic probe, wherein the transducer module includes a single ultrasonic transducer configured to apply ultrasonic therapy to tissue at multiple focal depths.

[0206] In some embodiments, an ultrasonic treatment system for generating multiple foci simultaneously at multiple depths within tissue with one ultrasonic transducer, the system comprising a control device operably controlling an ultrasonic treatment function to provide ultrasonic treatment, and a hand wand configured to guide ultrasonic therapy to form a sequence of a plurality of individual thermal cosmetic treatment zones, the hand wand including a transducer configured to apply ultrasonic therapy to tissue at multiple positions at the focal depth. One embodiment is a non-invasive cosmetic treatment of the skin.

[0207] In some embodiments, an imaging and treatment system for use in cosmetic procedures at multiple depths within tissue, the system comprising: an ultrasound probe configured to perform ultrasound imaging and ultrasound treatment of tissue at multiple focal depths, the ultrasound probe including a transducer module configured to be coupled to the ultrasound probe, the transducer module including an ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations at multiple focal depths; a first switch for operably controlling the ultrasound imaging function to provide ultrasound imaging; a second switch for operably controlling the ultrasound treatment function to provide ultrasound treatment; a drive mechanism configured to guide ultrasound treatment to form at least one sequence of multiple individual thermal cosmetic treatment zones, the transducer module configured to be operably coupled to at least one of the first switch, the second switch, and the drive mechanism; and a control module, the control module including a processor and a display for controlling the transducer module. In one embodiment, the multiple locations are arranged in a substantially linear sequence within the cosmetic treatment zones. The imaging and treatment system may include a first set of multiple positions located within a first cosmetic treatment zone and a second set of multiple positions located within a second cosmetic treatment zone, wherein the first zone is distinct from the second zone. In one embodiment, the first cosmetic treatment zone includes a substantially linear sequence of first sets of multiple positions, and the second cosmetic treatment zone includes a substantially linear sequence of second sets of multiple positions. The transducer module may be configured to apply ultrasound therapy using amplitude modulation, in which case multiple parts of the transducer module are configured to emit ultrasound therapy at multiple amplitudes of acoustic intensity, where the first amplitude is distinct from the second amplitude. In one embodiment, the transducer module is configured to apply ultrasound therapy phase shift, in which case multiple parts of the transducer module are configured to emit ultrasound therapy at multiple phases of acoustic intensity, where the first phase is distinct from the second phase.The transducer module can be configured to apply ultrasound therapy using amplitude modulation, in which case multiple parts of the transducer module are configured to emit ultrasound therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. Furthermore, it can be configured to apply ultrasound therapy phase shift, in which case multiple parts of the transducer module are configured to emit ultrasound therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase. In one embodiment, the multiple phases include discrete phase values. The transducer module may include a piezoelectric material, and multiple parts of the transducer module are configured to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the transducer module. In one embodiment, the plurality of changes in the piezoelectric material include at least one of expansion of the material and contraction of the material. At least part of the transducer module can be configured to emit ultrasound therapy at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasound therapy emitted by at least part of the transducer module changes over time. In one embodiment, the drive mechanism is configured to be programmable to provide variable spacing between a plurality of individual thermal cosmetic treatment zones. A sequence consisting of multiple individual thermal cosmetic treatment zones can have treatment intervals ranging from 0.01 mm to 25 mm. In one embodiment, the first and second switches include buttons or keys operated by the user. At least one of the first and second switches can be activated by a control module. In one embodiment, the function of the treatment is at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, vaginal rejuvenation, and acne treatment. The transducer module can be configured to provide an acoustic output for ultrasonic treatment ranging from 10 W to 1000 W and a frequency of 1 MHz to 10 MHz in order to thermally heat the tissue and induce coagulation.

[0208] In some embodiments, a multifocal ultrasound treatment system for simultaneous treatment at multiple depths includes a control device that operably controls an ultrasound treatment function to provide ultrasound treatment, and a hand wand configured to guide ultrasound treatment to form a sequence of multiple individual thermal cosmetic treatment zones, the hand wand including a transducer configured to apply ultrasound treatment to tissue at a location at a focal depth, the locations being located within a thermal cosmetic treatment zone, and the transducer further configured to apply ultrasound treatment to tissue simultaneously at multiple locations at a focal depth.

[0209] In some embodiments, a multi-depth imaging and simultaneous multi-focus treatment system includes a module comprising an ultrasonic transducer configured to apply ultrasound treatment to tissue at multiple focal depths by at least one of the group consisting of amplitude modulation polarization and phase shift, and the module further includes an interface guide designed to be detachably coupled to a handwand so as to be able to provide electronic communication and power between the module and the handwand. In one embodiment, the multiple locations are arranged in a substantially linear sequence within a cosmetic treatment zone. A first set of multiple locations may be arranged in a first cosmetic treatment zone, and a second set of multiple locations may be arranged in a second cosmetic treatment zone, the first zone being distinct from the second zone. In one embodiment, the first cosmetic treatment zone includes a substantially linear sequence of the first set of multiple locations, and the second cosmetic treatment zone includes a substantially linear sequence of the second set of multiple locations. The ultrasonic transducer can be configured to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic therapy phase shift, in which case multiple parts of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase. The ultrasonic transducer can be configured to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude, and furthermore, it can be configured to apply ultrasonic therapy phase shift, in which case multiple parts of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple phases of acoustic intensity, where 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 multiple parts of the ultrasonic transducer are configured to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the plurality of changes in the piezoelectric material include at least one of expansion of the piezoelectric material and contraction of the piezoelectric material. At least part of the ultrasonic transducer may be configured to emit ultrasonic therapy at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasonic therapy emitted by at least part of the piezoelectric material changes over time. In one embodiment, the imaging and treatment system further includes a drive mechanism configured to be programmable to provide spacing between a plurality of individual cosmetic treatment zones. A sequence consisting of a plurality of individual cosmetic treatment zones may have treatment intervals ranging from 1 mm to 50 mm. In one embodiment, ultrasound therapy is at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, vaginal rejuvenation, and acne treatment. The ultrasound transducer can be configured to provide an acoustic output for ultrasound therapy ranging from 1W to 100W and a frequency ranging from 1MHz to 10MHz in order to thermally heat the tissue and cause coagulation.

[0210] In some embodiments, a treatment system for simultaneous treatment at multiple depths includes a control device that operably controls an ultrasound treatment function to provide ultrasound treatment, and a hand wand configured to guide ultrasound treatment to form a sequence of multiple individual thermal cosmetic treatment zones, the hand wand including an ultrasound transducer configured to simultaneously apply ultrasound treatment to tissue at multiple locations at focal depth.

[0211] In some embodiments, a non-invasive method for simultaneously performing cosmetic procedures at multiple depths that are not performed by a physician, the method comprising coupling a transducer module with an ultrasound probe, wherein the transducer module includes an ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations at the depth of focus by at least one of the group consisting of amplitude modulation polarization and phase shift, and the ultrasound probe includes a first switch for controlling acoustic imaging, a second switch for controlling acoustic treatment to induce multiple individual cosmetic treatment zones, and a drive mechanism for providing a desired interval between the multiple individual cosmetic treatment zones, the method comprising coupling the transducer module with an ultrasound probe, bringing the transducer module into contact with the skin surface of a subject, activating the first switch on the ultrasound probe to acoustically image a region below the skin surface, and activating the second switch on the ultrasound probe to acoustically treat a region below the skin surface by the transducer module in a desired sequence of multiple individual cosmetic treatment zones controlled by the drive mechanism.

[0212] In some embodiments, the imaging and treatment system is thus used for non-invasive cosmetic procedures on the skin.

[0213] In some embodiments, an ultrasound treatment system for dithering multiple simultaneous focal points from a single ultrasound transducer at multiple depths includes an ultrasound probe having a single transducer element adapted to simultaneously apply ultrasound treatment to tissue at multiple focal depths spaced apart from each other, wherein the ultrasound transducer is polarized by at least a first polarization configuration and a second polarization configuration; and a control module coupled to the ultrasound probe for controlling the ultrasound transducer, which changes the distance between spaced-apart positions via dithering of the first and second focal zones, thereby allowing precise movement of the beam focal point at spaced-apart positions by dithering via frequency modulation. The multiple positions can be arranged in a linear sequence within a cosmetic treatment zone, and the spaced-apart positions are spaced apart by spatial dithering via frequency swing. In one embodiment, a first set of multiple positions is located within a first cosmetic treatment zone, and a second set of multiple positions is located within a second cosmetic treatment zone, wherein the first zone is distinct from the second zone. An ultrasonic transducer can be adapted to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. In one embodiment, at least part of the ultrasonic transducer is adapted to emit ultrasonic therapy at two or more amplitudes of acoustic intensity, where the amplitude of ultrasonic therapy emitted by at least part of the piezoelectric material changes over time. The ultrasonic transducer may include a piezoelectric material, and multiple parts of the ultrasonic transducer are adapted to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the plurality of changes in the piezoelectric material include at least one of expansion of the piezoelectric material and contraction of the piezoelectric material. An ultrasonic transducer can be adapted to apply ultrasonic therapy via phase shift, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase.In one embodiment, the multiple phases include discrete phase values. The ultrasonic transducer can be adapted to apply ultrasonic therapy using amplitude modulation, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. Furthermore, it can be adapted to apply ultrasonic therapy, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase. In one embodiment, the ultrasonic therapy is at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, décolletage improvement, buttock lift, scar reduction, burn treatment, skin tightening, vasoconstriction, sweat gland treatment, sunspot removal, fat treatment, abdominal relaxation treatment, and cellulite treatment. The ultrasonic probe may include a drive mechanism adapted to guide the ultrasonic therapy to form at least one pair of simultaneous sequences consisting of multiple individual thermal cosmetic treatment zones. In one embodiment, the ultrasound probe is configured to perform both ultrasound imaging and ultrasound therapy. The ultrasound probe may include a transducer module adapted for applying ultrasound therapy.

[0214] In some embodiments, an ultrasound treatment system for use in cosmetic procedures for dithering multiple simultaneous focal points from a single ultrasound transducer at multiple depths, the system comprising: an ultrasound probe, which includes a control module adapted to change the distance between a first focal zone and a second focal zone via dithering; a switch for operably controlling the ultrasound treatment function to provide ultrasound treatment; and a drive mechanism adapted to guide ultrasound treatment to form at least one pair of simultaneous sequences consisting of multiple individual thermal cosmetic treatment zones; a transducer module adapted to apply ultrasound treatment, which includes an ultrasound transducer adapted to perform both ultrasound imaging and ultrasound treatment, adapted to be coupled to the ultrasound probe, and adapted to apply ultrasound treatment to tissue at multiple locations having at least two focal depths, and adapted to be operably coupled to at least one of the switch and the drive mechanism; and a control module, which includes a processor and a display for controlling the transducer module. In one embodiment, the transducer module is adapted to apply ultrasound therapy using amplitude modulation, in which case multiple parts of the transducer module are adapted to emit ultrasound therapy at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. The transducer module can be adapted to apply ultrasound therapy, in which case multiple parts of the transducer module are adapted to emit ultrasound therapy at multiple phases of acoustic intensity, where the first phase is different from the second phase.

[0215] In some embodiments, an ultrasonic treatment system for dithering simultaneous multi-focus treatment at multiple depths includes a module containing an ultrasonic transducer, which is adapted to simultaneously apply ultrasonic treatment to tissue at multiple spaced depths within the tissue, and the module changes the spacing between the multiple spaced depths via dithering between a first focal zone and a second focal zone, thereby allowing precise movement of the beam focus at multiple spaced depths by frequency-modulated dithering, and the module further includes an interface guide designed to be detachably coupled to a handwand so as to provide electronic communication and power between the module and the handwand. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic treatment using amplitude modulation, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic treatment at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. The ultrasonic transducer can be adapted to apply ultrasonic treatment, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic treatment at multiple phases of acoustic intensity, where the first phase is different from the second phase. In one embodiment, the ultrasonic transducer comprises a piezoelectric material, and multiple parts of the ultrasonic transducer are adapted to produce a corresponding set of changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. At least a portion of the ultrasonic transducer can be adapted to emit ultrasonic therapy at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasonic therapy emitted by at least a portion of the ultrasonic transducer remains constant over time. In one embodiment, the ultrasonic therapy is at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, décolletage improvement, buttock lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, cellulite treatment, abdominal relaxation treatment, vaginal rejuvenation, and acne treatment.

[0216] In some embodiments, a method for dithering multiple simultaneously focused ultrasound treatment beams at multiple depths includes preparing an ultrasound probe including an ultrasound transducer having a single converter element adapted to simultaneously apply ultrasound treatment to tissue at multiple spaced positions at multiple focal depths, and a control module coupled to the ultrasound probe for controlling the ultrasound transducer, and moving the position of the ultrasound focus at multiple spaced positions by dithering the spacing between multiple spaced positions of a first focal zone and a second focal zone via frequency modulation. In one embodiment, the method includes imaging the first focal zone with an ultrasound image sensor. The method may further include imaging the second focal zone with an ultrasound image sensor. In one embodiment, the spacing between the first and second focal zones is dithered in the range of 1% to 50%. The spacing between the first and second focal zones can be 1.5 mm, in increments of 0.1 mm. In one embodiment, the frequency modulation is in the range of 1% to 50%. Ultrasound treatment can be at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, décolletage improvement, buttock lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, vaginal rejuvenation, abdominal relaxation treatment, and acne treatment.

[0217] In some embodiments, a method for simultaneously dithering a single focused ultrasound beam at multiple depths involves preparing an ultrasound probe comprising a single transformer and a control module, wherein the single transformer is adapted to apply ultrasound therapy to tissue in a focal zone at the focal depth, and the control module is coupled to the ultrasound probe to control the single transformer; and the size of the focal zone at the tissue is changed by dithering the focal zone via frequency modulation. In one embodiment, the relative position of the focal zone is dithered in the range of 1% to 50%. A second focal zone may be emitted simultaneously from the single transformer. In one embodiment, the frequency modulation is in the range of 1% to 50%. The system can be designed to operate non-invasively when treating tissue. In one embodiment, this method functions in a non-invasive manner when treating tissue.

[0218] In some embodiments, an ultrasonic treatment system for delivering simultaneous multi-focus treatment at multiple depths by electrostrictive elements includes a module comprising an ultrasonic transducer, which is adapted to simultaneously apply ultrasonic treatment to tissue at multiple spaced depths within the tissue by application of an electrostrictive element, and the module modulates the spacing between the multiple spaced depths within the tissue via dithering of first and second focal zones, thereby allowing precise movement of the beam focus at the multiple spaced depths via frequency modulation dithering, and the module further includes an interface guide designed to be detachably coupled to a handwand so as to provide electronic communication and power between the module and the handwand. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic treatment using amplitude modulation, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic treatment at multiple amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude. An ultrasonic transducer can be adapted to apply ultrasonic therapy, in which case multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy in multiple phases of acoustic intensity, where the first phase is different from the second phase. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and multiple parts of the ultrasonic transducer are adapted to generate multiple corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. At least a portion of the ultrasonic transducer can be adapted to emit ultrasonic therapy in two or more amplitudes of acoustic intensity, where the amplitude of the ultrasonic therapy 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 the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, décolletage improvement, buttock lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, cellulite treatment, abdominal relaxation treatment, vaginal rejuvenation, and acne treatment.

[0219] Some embodiments are ultrasonic treatment systems having one or more of the features described above.

[0220] Some embodiments are methods for reducing imaging positional shift in a moving ultrasonic transducer, having one or more of the features described above.

[0221] Some embodiments are ultrasonic treatment systems for generating multiple simultaneous focal points from a single ultrasonic transducer, having one or more of the features described above.

[0222] Some embodiments are ultrasonic treatment systems for delivering multi-focal treatments, having one or more of the features described above.

[0223] Some embodiments are ultrasonic treatment modules for use in cosmetic procedures, having one or more of the features described above, for forming multiple simultaneous focal zones from a single ultrasonic transducer.

[0224] Some embodiments are methods for generating multiple simultaneously focused ultrasonic treatment beams using multi-channel signal mixing, having one or more of the features described above.

[0225] Some embodiments are methods for generating multiple simultaneously focused ultrasonic beams having one or more of the features described above.

[0226] Some embodiments and examples described herein are illustrative and are not intended to limit the scope of the compositions and methods of these inventions. Equivalent changes, modifications, and variations with respect to several embodiments, materials, compositions, and methods can be made within the scope of the present invention, with substantially similar results.

[0227] Although various modifications and alternative forms of the present invention are possible, specific examples thereof have been described in detail herein with reference to the drawings. However, it will be understood that the present invention is not limited to any particular form or method disclosed, but rather encompasses all modifications, equivalents, and alternatives that fall within the spirit and scope of the various embodiments and appended claims described herein. None of the methods disclosed herein need to be performed in the order described herein. The methods disclosed herein include specific actions performed by the practitioner, but may also include any third-party instructions regarding those actions, explicitly or implicitly. For example, an action such as "combining the transducer module with the ultrasound probe" includes "instructing to combine the transducer module with the ultrasound probe." The scope disclosed herein also includes all overlaps, sub-scopes, and combinations thereof. Terms such as "up to," "at least," "greater than," "less than," and "between" include the stated numerical values. Numerical values ​​following terms such as "about" or "approximately" include the stated numerical values. For example, "about 25 mm" includes "25 mm." [Explanation of symbols]

[0228] 10 Areas of Interest 20 Ultrasonic Systems 50 Energy released 100 Hand Wands 130 Interfaces 150 Imaging controllers, switches 160 Heat treatment controllers, switches 200 modules 270 Offset distance 278 Depth of focus 279. Tissue depth 280 Ultrasonic transducer 281 Therapeutic channel, Therapeutic channel annular transducer element 282 Convex 283 Concave 285 Image Converter 300 controllers 310 Interactive Graphic Display 320 Access Keys 400 Drive mechanism 500 target individuals 501 Skin surface 502 Epidermal layer 503 Dermal layer 504 Subcutaneous tissue 505 Fat layer 507 Superficial fascial layer, SMAS layer 509 Muscle layer 510 Subcutaneous tissue 525 Treatment Zone 550 thermal solidification zones, thermal solidification points, TCP

Claims

1. An ultrasonic treatment system for dithering multiple simultaneous focal points from a single ultrasonic transducer at multiple depths, An ultrasonic transducer having a single converter element adapted to simultaneously apply ultrasonic therapy to tissue at multiple depths, comprising an ultrasonic probe including an ultrasonic transducer that generates a first focal zone at a first depth among the multiple depths and a second focal zone at a second depth among the multiple depths below the skin surface, The ultrasonic transducer comprises a control module coupled to the ultrasonic probe for controlling the ultrasonic transducer, The control module expands the first and second focus zones and changes the spacing between the multiple depths by dithering the first focus zone at the first depth and the second focus zone at the second depth, thereby shifting the position of the beam focus in the first and second focus zones by dithering via frequency modulation. An ultrasonic treatment system in which dithering is performed by mechanically and / or electronically scattering the focal points of the ultrasonic beam in the first focal zone and the second focal zone by changing the frequency of the ultrasonic beam and the focal point of the ultrasonic beam.

2. The treatment system according to claim 1, wherein a first set of depths among the plurality of depths is located within a first cosmetic treatment zone, a second set of focal depths among the plurality of depths is located within a second cosmetic treatment zone, and the first cosmetic treatment zone is different from the second cosmetic treatment zone.

3. The treatment system according to claim 1, wherein the ultrasonic transducer is adapted to apply ultrasonic therapy using amplitude modulation, so that multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity.

4. The treatment system according to claim 2, wherein the ultrasonic transducer includes a piezoelectric material, and a plurality of parts of the ultrasonic transducer are adapted to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer.

5. The treatment system according to claim 3, wherein the ultrasonic transducer includes a piezoelectric material, and the plurality of parts of the ultrasonic transducer are adapted to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer.

6. The treatment system according to claim 5, wherein the plurality of changes in the piezoelectric material include at least one of expansion of the piezoelectric material and contraction of the piezoelectric material.

7. The treatment system according to any one of claims 1 to 3, wherein the ultrasonic transducer is adapted to apply ultrasonic treatment via a phase shift, so that multiple portions of the ultrasonic transducer are adapted to emit ultrasonic treatment at multiple phases of acoustic intensity.

8. The treatment system according to claim 7, wherein the plurality of phases include discrete phase values.

9. The ultrasonic transducer is The ultrasonic treatment is applied using amplitude modulation, such that multiple parts of the ultrasonic transducer emit ultrasonic treatment at multiple amplitudes of acoustic intensity, and The treatment system according to any one of claims 1 to 3, wherein multiple parts of the ultrasonic transducer emit ultrasonic treatment at multiple phases of acoustic intensity, and ultrasonic treatment is applied using amplitude modulation.

10. The treatment system according to any one of claims 1 to 3, wherein the ultrasound treatment is at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, décolletage improvement, buttock lift, scar reduction, burn treatment, skin tightening, vasoconstriction, sweat gland treatment, sunspot removal, fat treatment, abdominal relaxation treatment, and cellulite treatment.

11. The treatment system according to any one of claims 1 to 3, wherein the ultrasound probe includes a drive mechanism adapted to guide ultrasound treatment to form at least one pair of simultaneous sequences consisting of a plurality of individual thermal cosmetic treatment zones.

12. The treatment system according to any one of claims 1 to 3, wherein the ultrasound probe is configured to perform both ultrasound imaging and ultrasound treatment.

13. The treatment system according to any one of claims 1 to 3, wherein the ultrasound probe includes a transducer module adapted for applying ultrasound therapy.

14. An ultrasonic treatment system for providing simultaneous multi-focus treatment at multiple depths using an electrostrictive element, Includes a module containing an ultrasonic transducer, The aforementioned ultrasonic transducer, by applying an electrostrictive element, simultaneously applies ultrasonic treatment to tissue at multiple depths within the tissue, thereby generating two or more simultaneous focal zones below the skin surface. The module expands the two or more simultaneous focus zones, moves the position of the beam focus in each of the two or more simultaneous focus zones by dithering via frequency modulation, and changes the spacing between the multiple depths by the dithering for each of the two or more simultaneous focus zones. The module further includes an interface guide designed to be detachably coupled to the hand wand so as to be able to provide electronic communication and power between the module and the hand wand. An ultrasonic treatment system in which dithering is performed by mechanically and / or electronically scattering the beam focus in the two or more simultaneous focal zones by changing the frequency of the ultrasonic beam.

15. The treatment system according to claim 14, wherein the ultrasonic transducer is adapted to apply ultrasonic therapy using amplitude modulation, so that multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity.

16. The treatment system according to claim 14, wherein the ultrasonic transducer is adapted to apply ultrasonic therapy, and thereby multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy in multiple phases of acoustic intensity.

17. The treatment system according to claim 14, wherein the ultrasonic transducer includes an electrostrictive material, and a plurality of portions of the ultrasonic transducer are adapted to generate a plurality of corresponding changes in the electrostrictive material in response to an electric field applied to the ultrasonic transducer.

18. The treatment system according to claim 14, wherein at least a portion of the ultrasonic transducer is adapted to emit ultrasonic therapy at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasonic therapy emitted by at least a portion of the ultrasonic transducer remains constant over time.

19. The treatment system according to any one of claims 14 to 18, wherein the ultrasonic treatment performed by the ultrasonic treatment system is at least one of the following: facelift, eyebrow lift, jaw lift, eye treatment, wrinkle reduction, décolletage improvement, buttock lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sunspot removal, fat treatment, cellulite treatment, abdominal relaxation treatment, vaginal rejuvenation, and acne treatment.

20. An ultrasonic system for dithering multiple simultaneous focal points from an ultrasonic transducer at multiple locations, An ultrasonic transducer having a single transforming element adapted to simultaneously focus ultrasound at multiple locations, comprising an ultrasonic probe including an ultrasonic transducer that generates a first focal zone at a first location and a second focal zone at a second location beneath the skin surface, The ultrasonic transducer comprises a control module coupled to the ultrasonic probe for controlling the ultrasonic transducer, The control module expands the first and second focus zones and changes the spacing between the plurality of positions by dithering the first focus zone at the first position and the second focus zone at the second position, thereby shifting the position of the beam focus in the first and second focus zones by dithering via frequency modulation. An ultrasonic system in which dithering is mechanically and / or electronically scattered at the position of the beam focal point in a first focal zone and a second focal zone by changing the frequency of the ultrasonic beam and the focal point of the ultrasonic beam.

21. The ultrasonic system according to claim 20, wherein the ultrasonic transducer is adapted to apply ultrasound using amplitude modulation, so that a plurality of parts of the ultrasonic transducer are configured to emit ultrasound at a plurality of amplitudes of acoustic intensity.

22. The ultrasonic system according to claim 21, wherein at least a portion of the ultrasonic transducer is configured to emit ultrasonic waves at the plurality of amplitudes of acoustic intensity, and the amplitude of the ultrasonic waves emitted by at least a portion of the piezoelectric material changes over time.

23. The ultrasonic system according to claim 21, wherein the ultrasonic transducer comprises a piezoelectric material, and the plurality of parts of the ultrasonic transducer are adapted to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer.

24. The ultrasonic system according to claim 23, wherein the plurality of changes in the piezoelectric material include at least one of expansion of the piezoelectric material and contraction of the piezoelectric material.

25. The ultrasonic system according to claim 20 or 21, wherein the ultrasonic transducer is adapted to apply ultrasound via a phase shift, so that a plurality of parts of the ultrasonic transducer are adapted to emit ultrasound at a plurality of phases of acoustic intensity.

26. The ultrasonic system according to claim 25, wherein the plurality of phases include discrete phase values.

27. The ultrasonic transducer is The ultrasonic transducer is configured such that multiple parts emit ultrasound at multiple amplitudes of acoustic intensity, thereby applying ultrasonic therapy using amplitude modulation, and The ultrasonic system according to claim 20 or 21, wherein multiple parts of the ultrasonic transducer are adapted to apply ultrasound by emitting ultrasound at multiple phases of acoustic intensity.

28. The ultrasonic system according to claim 20 or 21, wherein the ultrasonic probe includes a drive mechanism adapted to guide ultrasonic treatment to form at least one pair of simultaneous sequences consisting of individual thermal cosmetic treatment zones.

29. The ultrasound system according to claim 20 or 21, wherein the ultrasound probe is configured to perform both ultrasound imaging and ultrasound treatment.

30. An ultrasonic system for simultaneously delivering multiple-focus ultrasonic waves to multiple locations using an electrostrictive element, Includes a module containing an ultrasonic transducer, The ultrasonic transducer applies ultrasound simultaneously at multiple spaced positions by applying an electrostrictive element, thereby generating a first focal zone at the first position and a second focal zone at the second position beneath the skin surface. The module moves the position of the beam focus in the first and second focal zones by dithering via frequency modulation, thereby changing the spacing between the multiple spaced-apart positions by the dithering to the first and second focal zones. The dithering involves mechanically and / or electronically scattering the beam focal points in the first and second focal zones by changing the frequency of the ultrasonic beam. An ultrasonic system comprising, the module further including an interface guide designed to be detachably coupled to the hand wand so as to be able to provide electronic communication and power between the module and the hand wand.

31. The ultrasonic system according to claim 30, wherein the ultrasonic transducer is adapted to apply ultrasound using amplitude modulation, so that multiple parts of the ultrasonic transducer are adapted to emit ultrasound at multiple amplitudes of acoustic intensity.

32. The ultrasonic system according to claim 30, wherein the ultrasonic transducer is adapted to apply ultrasound, and thereby multiple parts of the ultrasonic transducer are adapted to emit ultrasound at multiple phases of acoustic intensity.

33. The ultrasonic system according to claim 30, wherein the ultrasonic transducer includes a piezoelectric material, and a plurality of parts of the ultrasonic transducer are adapted to generate a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer.

34. The ultrasonic system according to claim 30, wherein at least a portion of the ultrasonic transducer is adapted to emit ultrasound at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasound emitted by at least a portion of the ultrasonic transducer remains constant over time.

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