Systems and methods for simultaneous multi-focus ultrasound therapy in multiple dimensions

Abstract

To provide systems and methods that successfully achieve an aesthetic effect using targeted and precise ultrasound to allow a visible and effective cosmetic result via a thermal pathway.SOLUTION: Embodiments relates to a dermatological cosmetic treatment and / or an imaging system and method adapted to alter placement and position of multiple cosmetic treatment zones in tissue with ultrasound beams from a transducer, and / or adapted to alter simultaneous multi-focus therapy at multiple depths, and / or adapted to alter dithering of ultrasound beams from a transducer to alter placement and position of multiple cosmetic treatment zones in tissue. The system can include a hand wand 100, a removable transducer module, and a control module.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] Incorporation by Reference U.S. Provisional Patent Application No. 62 / 622,394, filed 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 achieving aesthetic and / or cosmetic enhancement effects on the skin and / or tissue near the skin of the human face, head, neck, and / or body by simultaneously or near-simultaneously delivering energy to multiple dimensions (e.g., depth, height, width, spacing, orientation, location) of tissue below the skin surface. [Background technology]

[0003] Some cosmetic procedures involve invasive procedures that may require invasive surgery. Patients must endure recovery periods of up to several weeks, as well as often undergo risky anesthesia procedures. Although non-invasive energy-based treatment devices and methods are available, they may have various shortcomings with regard to efficiency and effectiveness. Summary of the Invention

[0004] In some embodiments, systems and methods are provided that successfully achieve aesthetic effects using targeted precision ultrasound to split the ultrasound therapeutic beam into two, three, four or more simultaneous focal zones to produce visible and effective cosmetic results via thermal pathways during various treatment and / or imaging procedures. In various embodiments, the ultrasound system is configured to focus ultrasound with localized mechanical movements within tissues and cells to generate localized heating for either tissue coagulation or mechanical cell membrane disruption intended for non-invasive aesthetic use. In various embodiments, the ultrasound system is configured to lift brows (e.g., brow lift). In various embodiments, the ultrasound system is configured to lift loose, slack, or flaccid tissues, such as pituitary (under the chin) and neck tissues. In various embodiments, the ultrasound system is configured to improve décolletage lines and wrinkles. In various embodiments, the ultrasound system is configured to reduce fat. In various embodiments, the ultrasound system is configured to reduce the appearance of cellulite. In some embodiments, a system is provided that both reduces fat and then treats the loose skin that results from the fat reduction.

[0005] Although various embodiments for aesthetic procedures are contemplated herein, the systems and procedures described herein also find use in some embodiments for non-aesthetic applications.

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

[0007] In various embodiments, treating tissue, such as skin tissue, with multiple beams provides one or more advantages, such as, for example, reduced treatment time, generation of unique heating patterns, utilization of greater power by utilizing multiple channels, the option to treat the skin at two or more depths with the same or different power levels (e.g., thermal coagulation points within the superficial fascia ("SMAS") and other defocused energies at the skin surface, or other combinations), optional simultaneous treatment at different depths (e.g., thermal coagulation points at simultaneous or overlapping times at depths 1.5 mm, 3 mm, and / or 4.5 mm below the skin surface, etc.), and / or treatment with one, two, or more simultaneous linear or linear multiple foci, such as at different depths below the skin surface or at different depths spaced apart from one another. In some embodiments, simultaneous multi-focal treatment uses dithering.

[0008] According to one embodiment, an ultrasound treatment system creates two or more simultaneous therapeutic treatment points and / or focal zones below the skin surface for cosmetic treatment, and the treatment points are expanded by dithering the ultrasound beam. In one embodiment, the focal zone is a point. In one embodiment, the focal zone is a line. In one embodiment, the focal zone is a plane. In one embodiment, the focal zone is a three-dimensional volume or shape. Dithering the focus of the ultrasound beam expands the treatment area by changing the frequency of the ultrasound treatment beam, and thus the focus of the ultrasound treatment beam, by mechanically and / or electronically scattering the location of the focal spot, by making the focal spot or focal zone (e.g., focus, focal line, focal plane, or focal volume) shimmer, blur, or splatter, as if painting with an airbrush. In some embodiments, dithering increases the effect by creating larger treatment points and / or larger focal zones. In some embodiments, dithering reduces pain due to spreading the temperature of the hot spot to a larger volume of tissue, thereby allowing for a reduction in potential dose. In some embodiments, mechanical dithering is a method to spread the acoustic energy from an ultrasound beam so that tissues away from the focal point are less reliant on thermal conduction. In one embodiment of mechanical dithering, the therapeutic transducer is driven locally around the intended center of the thermal coagulation point (TCP). The acoustic beam movement can be side-to-side, up-down, and / or angular. In one embodiment of mechanical dithering, the movement of the drive mechanism is fast enough to produce a flatter temperature profile around the intended TCP, which allows for a reduction in the total amount of acoustic energy for the same affected tissue volume, or allows for a greater impact on the tissue volume with the same total amount of acoustic energy, or any combination of these.

[0009] According to various embodiments, frequency modulation changes the location of the focal spot and / or the spacing between focal zones such that electronic dithering of the beam via frequency modulation precisely changes and / or moves the location of the focal spot of the beam. For example, in one embodiment, a spacing of 1.5 mm can be dithered by ±0.1 mm using small frequency swings. In various embodiments, any one or more of the following spacings 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, ±0.30 mm using frequency swings. In various embodiments, the frequency is modulated by between 1% and 200% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 100%, 120%, 150%, 180%, 200%, and any range therein).

[0010] Some embodiments relate to devices, systems, and methods for providing one or more (e.g., multiple or multiple) focal zones and / or ultrasonic treatment points in performing various ultrasonic treatment and / or imaging procedures quickly, safely, efficiently, and effectively. In some embodiments, imaging is not used. Some embodiments relate to splitting an ultrasonic therapy beam into two, three, four, or more focal zones from a single ultrasonic transducer and / or a single ultrasonic transducer element. In some embodiments, multiple ultrasonic beams are electronically steered by frequency modulation. In some embodiments, dithering (e.g., electronic dithering) multiple and / or split ultrasonic beam apertures using frequency modulation provides treatment zones or treatment points at multiple locations. In some embodiments, dithering relates to deliberate movement of the location / location of the focal point of the energy beam. For example, in one embodiment, dithering includes shaking, moving, vibrating, changing the location and / or location of a single focal zone and / or the relative spacing between two or more focal zones. In various embodiments, the relative positions of the focal zones are dithered by 1%-50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, and any range therein, such as a ratio of the average position by a particular ratio). In various embodiments, the spacing between the focal zones is dithered by 1%-50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, and any range therein). In some embodiments, depending on the system design, dithering can be done 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 mechanical translation or tilt of the therapeutic transducer or patient, or any combination thereof. Mechanical translation and / or tilting allows for spreading of acoustic energy such that the thermal conductivity limitations of tissue are overcome.This creates a flatter temperature profile in the tissue, which can reduce the total acoustic energy required to produce the same affected tissue volume, or increase the tissue volume with the same total acoustic energy, compared to a stationary ultrasound treatment device. Various embodiments of electronic dithering can use frequency-based, phase-based, amplitude modulation-based, or time-based techniques to move the ultrasound beam in tissue without any mechanical movement, in combination with a uniquely defined transducer. In one embodiment, the electronic movement of the ultrasound beam occurs significantly faster than the mechanical movement to overcome the thermal conductivity limitations of the tissue. In various embodiments, the ratio of relative focal zone positioning via dithering is 1:1000, 1:500, 1:200, 1:100, 1:50, 1:25, 1:10, 1:2, or any ratio between 1:1000 and 1:1. In various embodiments, the ratio of the spacing between the relative focal zone positioning via dithering is 1:1000, 1:500, 1:200, 1:100, 1:50, 1:25, 1:10, 1:2, or any ratio between 1:1000 and 1:1. For example, in some embodiments, the focal zones are activated at "1" and the open spacing ratio of the untreated tissue is provided at a second number of the ratio. For example, in one embodiment, the dithering spacing is, for example, 1 mm and the dithering distance is 0.1 mm, so the ratio is 1:10. In various embodiments, the ratio of the spacing between the focal zones via dithering is 1:1000, 1:500, 1:200, 1:100, 1:50, 1:25, 1:10, 1:2, or any ratio between 1:1000 and 1:1. In some embodiments, the spacing between simultaneous focal zones is dithered. In some embodiments, treatment points and / or treatment zones are formed simultaneously in tissue. In various embodiments, the dithering to perform various treatment and / or imaging procedures is modulated and / or polyphasic with controlled changes in frequency.Some embodiments relate to splitting an ultrasound therapy beam into two, three, four or more focal zones, for example in conjunction with dithering, polarization, phasing, modulation techniques, in performing various treatment procedures, and / or in performing imaging procedures.

[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: Namely, face lift, brow lift, chin lift, eye treatment (e.g., treatment of cheek pouches, infraorbital laxity), wrinkle reduction, fat reduction (e.g., treatment of fat and / or cellulite), treatment of cellulite (which may be referred to as glenoid lipodystrophy) (e.g., female glenoid lipodystrophy, either dimple type or non-dimple type), décolletage improvement (e.g., upper chest), buttock lift (e.g., buttock tightening), skin tightening (e.g., treatment of laxity to cause tightening of the face or body, such as the face, neck, chest, arms, thighs, abdomen, buttocks, etc.), scar reduction (e.g., reduction of breast fibrosis), burn treatment, tattoo removal, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, acne treatment, and acne reduction. Some embodiments of the present invention are particularly advantageous because they include one, some, or all of the following benefits: The advantages of the present invention include: (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 to complete treatment; and / or (viii) larger treatment area based on 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 at multiple depths simultaneously. In one embodiment, an advantage is eliminating the need for multiple transducers, thereby reducing transducer replacement by an operator. In one embodiment, an advantage is faster treatment time. In one embodiment, an advantage is delivering the same number of lines with fewer button presses. In one embodiment, an advantage is modulating the distance between simultaneously delivered TCPs. In one embodiment, an advantage is maintaining the pitch separation of the TCPs at each depth along the line of mechanical movement.In one embodiment, the advantage is to avoid pulse stacking at multiple depths. In one embodiment, the advantage is the ability to create 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 electrostrictive elements includes creating three or more lines with one transducer placed on the patient's body. In one embodiment, the advantage of using electrostrictive elements 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 treatment modulation pattern. In one embodiment, the advantage of using electrostrictive elements provides the possibility to add nulls to the modulation pattern. In one embodiment, the advantage of using electrostrictive elements is to effectively modulate the distance between simultaneously delivered TCPs while providing electronic steering and focusing control on the opposite surface. This can be in the form of stripes orthogonal to the electrostrictive stripes, annular rings, and segments (or at any angle relative to each other, e.g., 0°-180° (5°, 10°, 15°, 20°, 30°, 45°, 60°, 90°, or more)). In various embodiments, the transducer can be segmented. In various embodiments, a planar transducer can be focused using a lens. In various embodiments, the transducer is spherically focused to one or more points. In various embodiments, the transducer is cylindrically focused to one or more lines.

[0012] According to various embodiments, a cosmetic ultrasound treatment system and / or method can non-invasively generate single or multiple dithered cosmetic treatment zones and / or thermal coagulation points, where ultrasound is focused to one or more locations within a treatment region 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 locations. In one embodiment, the method and system includes a multiple depth / height / width transducer system configured to provide ultrasound treatment to one or more regions of interest, such as between at least one depth of the treatment region of interest, a surface region of interest, and / or a subcutaneous region of interest. In one embodiment, the method and system includes a transducer system configured to provide ultrasound treatment to one or more regions of interest, such as between at least two points at various locations (e.g., fixed or variable depths, heights, widths, and / or orientations, etc.) within the region of interest within tissue. Some embodiments can split the beam to focus into two, three, four or more focal points (e.g., multiple focal points, multi-foci) for cosmetic treatment zones and / or imaging of regions of interest in tissue. The position and / or dithering of the focal points can be located axially, laterally, or otherwise within the tissue. Some embodiments can be configured to provide spatial control, such as by position and / or dithering of the focal points, and / or by changing the distance from the transducer to the reflecting surface, and / or by changing the angle of the focused or defocused energy relative 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 of the multiple treatment zones or focal points can be achieved by polarization, phase polarization, biphasic polarization, and / or multiphasic polarization.In some embodiments, the locations of multiple treatment zones or focal points are phased, such as electrically phased in one embodiment, so that the location, number, shape, size, and / or volume of treatment zones or lesions within a region of interest, as well as thermal conditions, can be dynamically controlled over time.

[0013] According to various embodiments, the 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 transform, which can generate any spatially periodic pattern with one or more ultrasonic portions. In one embodiment, the system uses polarization at the ceramic level to deliver single or multiple treatment zones simultaneously or sequentially. In one embodiment, the polarization pattern is a function of focal depth and frequency, and also the use of odd or even functions. In one embodiment, a polarization pattern that can be a combination of odd or even functions is applied based on focal depth and / or frequency. In one embodiment, the process can be used in two or more dimensions to generate any spatially periodic pattern. In one embodiment, the ultrasound beam is split axially and laterally, which can significantly reduce treatment time through the use of nonlinear acoustics and Fourier transform. In one embodiment, multiple treatment zones can be placed in tissue, either sequentially or simultaneously, 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 including an ultrasound transducer configured to apply ultrasound therapy to tissue at multiple locations at a focal depth by electronic dithering of multiple energy beam apertures with 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 the multiple individual cosmetic treatment zones. In one embodiment, the sequence of multiple individual cosmetic treatment zones has a treatment spacing in the range of about 0.01 mm to about 25 mm (e.g., 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 5 mm, 10 mm, 20 mm, and any value therein) with a dithering change in spacing of 1% to 50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, and any range therein). In one embodiment, the sequence of multiple individual cosmetic treatment zones has a treatment interval in the range of about 0.01 mm to about 100 mm (e.g., 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 5 mm, 10 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm, 100 mm, and any value therein) with a dithering change in interval of 1% to 50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, and any range therein).

[0016] In one embodiment, the system further includes a drive mechanism configured to be programmable to provide fixed or variable spacing between the multiple individual cosmetic treatment zones. In one embodiment, the sequence of multiple individual cosmetic treatment zones has a treatment spacing in the range of about 0.01 mm to about 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 therein). In one embodiment, the sequence of discrete cosmetic treatment zones has a treatment spacing in the range of about 0.01 mm to about 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 therein). In one embodiment, the treatment zones are provided along a distance of about 25 mm. In one embodiment, the treatment zones are provided along a distance of about 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, or any range or value therein). In various embodiments, the treatment zones are provided along a linear distance and / or along a curved distance.

[0017] For example, in some non-limiting embodiments, the transducer can be configured to accommodate 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, more than 4.5 mm, more 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, and any depth therein (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 achieved at a depth below the skin surface results in a favorable cosmetic appearance of the skin surface. In other embodiments, the skin surface is treated with ultrasound (e.g., at a depth below 0.5 mm).

[0018] One advantage of the drive mechanism is that it may provide more efficient, more accurate and more precise use of the ultrasound transducer for imaging and / or therapeutic purposes. One advantage of this type of drive mechanism is that it is superior to conventional fixed arrays of transducers fixed in space within a housing, spaced apart by a fixed distance. In one embodiment, the transducer module is configured to provide ultrasonic therapeutic acoustic power 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 more, and a frequency of about 1MHz to about 20MHz to thermally heat tissue to cause coagulation. In one embodiment, the transducer module is configured to provide ultrasonic therapeutic acoustic power in the range of about 1 W to about 500 W peak or average energy (e.g., 3 W to 30 W, 7 W to 30 W, 21 W to 33 W, 100 W, 220 W, or more) and a frequency of about 1 MHz to about 20 MHz to thermally heat tissue to induce coagulation. In some embodiments, instantaneous energy is delivered. In some embodiments, average energy is delivered. In one embodiment, acoustic power can range from 1 W to about 100 W in a frequency range of about 1 MHz to about 20 MHz (e.g., 1 MHz, 3 MHz, 4 MHz, 4.5 MHz, 7 MHz, 10 MHz, 2 MHz to 12 MHz, 15 MHz, 18 MHz, 2 MHz to 18 MHz) or can range from about 10 W to about 50 W in a frequency range of about 3 MHz to about 8 MHz (e.g., 3 MHz, 4 MHz, 4.5 MHz, 7 MHz). In one embodiment, the acoustic power can range from 1 W to about 500 W in a frequency range of about 1 MHz to about 12 MHz (e.g., 1 MHz, 4 MHz, 7 MHz, 10 MHz, 2 MHz to 12 MHz), or from about 10 W to about 220 W in a frequency range of about 3 MHz to about 8 MHz, or 3 MHz to 10 MHz. In one embodiment, the acoustic power and frequency is about 40 W at about 4.3 MHz and about 30 W at about 7.5 MHz.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 for body shaping, sub-chin fat, abdomen and / or flanks, arms, inner thighs, outer thighs, buttocks, abdominal relaxation, 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 power is 1 kW / cm. 2 ~100kW / cm 2 , 15kW / cm 2 ~75kW / cm 2 , 1kW / cm 2 ~5kW / cm 2 , 500W / cm 2 ~10kW / cm 2 , 3kW / cm 2 ~10kW / cm 2 , 15kW / cm 2 ~50kW / cm 2 , 20kW / cm 2 ~40kW / cm 2 , and / or 15 kW / cm 2 ~35kW / cm 2 , is.

[0019] In various embodiments, an ultrasonic treatment system for dithering multiple simultaneous focal points from an 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 therapy to tissue at multiple spaced apart locations at a focal depth. The ultrasonic transducer is polarized with at least a first polarization configuration and a second polarization configuration. The control module changes the spacing between the multiple spaced apart locations via dithering the first and second focal zones, thereby enabling precise movement of the beam focal point location at the multiple spaced apart locations via dithering via frequency modulation.

[0020] In one embodiment, the locations are arranged in a linear sequence within the cosmetic treatment zone, with the locations spaced apart from one another being spaced apart by intervals that are dithered via frequency swing. In one embodiment, a first set of the locations are arranged within a first cosmetic treatment zone, and a second set of the locations are arranged within a second cosmetic treatment zone, with the first zone being different from the second zone. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic treatment using amplitude modulation, where the portions of the ultrasonic transducer are adapted to emit ultrasonic treatment at multiple amplitudes of acoustic intensity, with the first amplitude being different from the second amplitude. In one embodiment, at least a portion of the ultrasonic transducer is adapted to emit ultrasonic treatment at two or more amplitudes of acoustic intensity, with the amplitude of ultrasonic treatment emitted by at least a portion of the piezoelectric body varying over time. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and the portions of the ultrasonic transducer are adapted to generate corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the changes in the piezoelectric material include at least one of an expansion of the piezoelectric material and a contraction of the piezoelectric material. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy via phase shifting, where multiple portions 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, where multiple portions 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 is further adapted to apply ultrasonic therapy, where multiple portions 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 following weight loss, whether natural or surgically induced weight loss.

[0021] In various embodiments, an ultrasonic treatment system for use in cosmetic treatment for dithering multiple simultaneous focal points from an ultrasonic transducer includes an ultrasonic probe including a control module adapted to vary the spacing between a first focal zone and a second focal zone via dithering, a switch operatively controlling an ultrasonic treatment function to provide ultrasonic treatment, and a drive mechanism adapted to direct the ultrasonic treatment to at least one pair of simultaneous sequences of a plurality of individual thermal cosmetic treatment zones, and a transducer module adapted to apply ultrasonic treatment. The ultrasonic module is adapted to perform both ultrasonic imaging and ultrasonic treatment. The ultrasonic module is adapted to be coupled to the ultrasonic probe. The ultrasonic module includes an ultrasonic transducer adapted to apply ultrasonic treatment to tissue at multiple locations at the focal depth. The ultrasonic module is adapted to be operatively 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 the ultrasound treatment using amplitude modulation, where the multiple portions of the transducer module are adapted to emit the ultrasound treatment at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. In one embodiment, the transducer module is adapted to apply the ultrasound treatment, where the multiple portions of the transducer module are adapted to emit the ultrasound treatment at multiple phases of acoustic intensity, the first phase being different from the second phase.

[0023] In various embodiments, an ultrasonic treatment system for dithering multi-focal treatment includes a module including an ultrasonic transducer adapted to simultaneously apply ultrasonic therapy to tissue at spaced apart locations within the tissue, the module altering the spacing between the spaced apart locations via dithering a first focal zone and a second focal zone, thereby enabling precise movement of the location of the beam focal point at the spaced apart locations via dithering by frequency modulation, and the module further includes an interface guide designed to removably couple to a hand wand to provide electronic communication and power between the module and the hand wand.

[0024] In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy using amplitude modulation, where multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy, where multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the ultrasonic transducer includes a piezoelectric material, where multiple portions of the ultrasonic transducer are adapted to generate 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, 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 ultrasound treatment is at least one of face lift, brow lift, chin lift, eye treatment (e.g., treatment of cheek pouches, infraorbital laxity), wrinkle reduction, décolletage improvement, buttocks lift, scar reduction, burn treatment, tattoo removal, skin tightening (e.g., treatment of abdominal laxity or skin tightening with respect to other areas of the body and face, such as any excess skin or tissue during or after weight loss, such as in the abdomen, buttocks, thighs, arms, and other areas), vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, vaginal rejuvenation, and acne treatment.

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

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

[0027] In various embodiments, a method of dithering a single focused ultrasound beam includes providing an ultrasound probe including a single transducer element and a control module, where the single transducer element is adapted to apply ultrasound therapy to tissue in a focal zone at a focal depth and the control module is coupled to the ultrasound probe for controlling the single transducer element, and varying a size of the focal zone at the tissue by dithering the focal zone via frequency modulation.

[0028] In one embodiment, the relative positions of the focal zones are dithered in the range of 1% to 50%. In one embodiment, the second focal zone is emitted simultaneously from a single transducer element. In one embodiment, the method includes imaging the focal zones with an ultrasound 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 an ultrasonic transducer includes an ultrasonic probe with an ultrasonic transducer configured to apply ultrasonic therapy to tissue at multiple locations with at least two focal depths by at least one of the group consisting of amplitude modulated polarization and phase shift, a drive mechanism configured to be programmable to provide spacing between multiple discrete cosmetic treatment zones, the sequence of multiple discrete cosmetic treatment zones having a treatment spacing in the range of 1 mm to 50 mm, and a control module coupled to the ultrasonic probe for controlling the ultrasonic transducer, the ultrasonic transducer configured to provide ultrasonic therapeutic acoustic power in the range of 10 W to 1000 W and a frequency of 1 MHz to 20 MHz to thermally heat tissue to cause coagulation, the multiple locations are arranged in a substantially linear sequence within the cosmetic treatment zone, and the ultrasonic transducer includes a single ultrasonic transducer element. In one embodiment, the first set of locations is disposed within a first cosmetic treatment zone and the second set of locations is disposed within a second cosmetic treatment zone, the first zone being different from the second zone. In one embodiment, the first cosmetic treatment zone includes a substantially linear sequence of the first set of locations and the second cosmetic treatment zone includes a substantially linear sequence of the second set of locations. In one embodiment, the ultrasonic transducer is configured to apply the ultrasonic treatment using amplitude modulation, where multiple portions of the ultrasonic transducer are configured to emit ultrasonic treatment at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude.

[0030] In one embodiment, the ultrasonic transducer is configured to apply an ultrasonic treatment phase shift, where the multiple portions of the ultrasonic transducer are configured to emit ultrasonic treatment at multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic treatment using amplitude modulation, where the multiple portions of the ultrasonic transducer are configured to emit ultrasonic treatment at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude, and further, the ultrasonic transducer is configured to apply an ultrasonic treatment phase shift, where the multiple portions of the ultrasonic transducer are configured to emit ultrasonic treatment at multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the multiple phases include discrete phase values. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and the multiple portions of the ultrasonic transducer are configured to generate corresponding multiple 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 an expansion of the piezoelectric material and a contraction of the piezoelectric material. In one embodiment, at least a portion of the ultrasonic transducer is configured to emit ultrasonic treatments 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 varies over time. In one embodiment, the driving mechanism is configured to be programmable to provide variable spacing between the plurality of discrete cosmetic treatment zones, and further includes one or more selectable tuning circuits. In one embodiment, the sequence of the plurality of discrete cosmetic treatment zones has a treatment spacing in the range of 1 mm to 25 mm, and further includes a tuning circuit. In one embodiment, the ultrasonic treatment is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, skin tightening, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, cellulite treatment, décolletage treatment, vaginal rejuvenation, and acne treatment. In one embodiment, the ultrasound transducer is configured to provide therapeutic ultrasound acoustic power in the range of 10 W to 100 W and a frequency of 1 MHz to 12 MHz to thermally heat tissue and induce coagulation.

[0031] In various embodiments, a treatment system for generating multiple focal points simultaneously at different depths with an ultrasonic transducer includes an ultrasonic probe including a first switch operably controlling an ultrasonic imaging function to provide ultrasonic imaging, a second switch operably controlling an ultrasonic treatment function to provide ultrasonic treatment, and a drive mechanism configured to guide the ultrasonic treatment to at least one sequence of a plurality of discrete thermal cosmetic treatment zones, a transducer module configured to apply ultrasonic treatment by at least one of the group consisting of amplitude modulated polarization and phase shift, the transducer module being configured to perform both ultrasonic imaging and ultrasonic treatment, configured to be coupleable to the ultrasonic probe, and including an ultrasonic transducer configured to apply ultrasonic treatment to tissue at a plurality of locations having at least two focal depths, the transducer module being 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.

[0032] In one embodiment, the ultrasonic treatment is a cosmetic treatment, and the locations are arranged in a substantially linear sequence within the cosmetic treatment zone. In one embodiment, the ultrasonic treatment is an aesthetic treatment, and a first set of the locations are arranged within a first treatment zone, and a second set of the locations are arranged within a second treatment zone, and the first zone is different from the second zone. In one embodiment, the first treatment zone includes a substantially linear sequence of a first set of the locations, and the second treatment zone includes a substantially linear sequence of a second set of the locations. In one embodiment, the transducer module is configured to apply ultrasonic treatment using amplitude modulation, where the portions of the transducer module are configured to emit ultrasonic treatment at multiple amplitudes of acoustic intensity, and the first amplitude is different from the second amplitude. In one embodiment, the transducer module is configured to apply ultrasonic treatment phase shift, where the portions of the transducer module are configured to emit ultrasonic treatment at multiple phases of acoustic intensity, and the first phase is different from the second phase. In one embodiment, the transducer module is configured to apply the ultrasound treatment using amplitude modulation, where the multiple portions of the transducer module are configured to emit the ultrasound treatment at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude, and further configured to apply an ultrasound treatment phase shift, where the multiple portions of the transducer module are configured to emit the ultrasound treatment at multiple phases of acoustic intensity, the first phase being 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 the multiple portions of the transducer module are configured to generate corresponding multiple changes in the piezoelectric material in response to an electric field applied to the transducer module. In one embodiment, the multiple changes in the piezoelectric material include at least one of material expansion and material contraction. In one embodiment, at least a portion of the transducer module is configured to emit the ultrasound treatment at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasound treatment emitted by at least a portion of the transducer module varies over time.In one embodiment, the drive mechanism is configured to be programmable to provide variable spacing between the multiple individual thermal cosmetic treatment zones. In one embodiment, the sequence of the multiple individual thermal cosmetic treatment zones has a treatment spacing ranging from 1 mm to 25 mm. In one embodiment, the first switch and the second switch include a user operated button or key. In one embodiment, at least one of the first switch and the second switch of the treatment system is activated by a control module. In one embodiment, the treatment function is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, cellulite treatment, décolletage treatment, vaginal rejuvenation, and acne treatment. In one embodiment, the transducer module is configured to provide therapeutic ultrasound acoustic power in the range of 10 W to 1000 W and frequencies of 1 MHz to 20 MHz to thermally heat tissue and induce coagulation.

[0033] In various embodiments, a treatment system for delivering simultaneous treatment at multiple depths includes a control device operatively controlling ultrasonic treatment functions to provide ultrasonic treatment, and a hand wand configured to guide the ultrasonic treatment to a sequence of multiple discrete thermal cosmetic treatment zones, the hand wand including a transducer configured to apply ultrasonic therapy to tissue at a location at the focal depth, the location being positioned within the thermal cosmetic treatment zone, the transducer further configured to apply ultrasonic therapy to tissue simultaneously at multiple locations at the focal depth.

[0034] In various embodiments, a method of performing a non-invasive cosmetic procedure on skin by generating multiple simultaneous focal points at multiple depths with a single transducer includes coupling a transducer module to an ultrasonic probe including 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 spacing between the multiple individual cosmetic treatment zones; contacting the transducer module against a skin surface of a subject; acoustically imaging an area below the skin surface with the transducer module by activating a first switch on the ultrasonic probe; and acoustically treating an area below the skin surface with a desired sequence of multiple individual cosmetic treatment zones controlled by the drive mechanism by activating a second switch on the ultrasonic probe, wherein the transducer module includes a single ultrasonic transducer configured to apply ultrasonic treatment to tissue at multiple focal depths.

[0035] In various embodiments, an ultrasonic treatment system for simultaneously generating multiple focal points at multiple depths within tissue with a single ultrasonic transducer includes a control device operatively controlling ultrasonic treatment functions to provide ultrasonic treatment, and a hand wand configured to guide the ultrasonic treatment to a sequence of multiple discrete thermal cosmetic treatment zones, the hand wand including a transducer configured to apply ultrasonic treatment to tissue at multiple locations at the focal depths.

[0036] In various embodiments, an imaging and treatment system for use in cosmetic treatment at multiple depths within tissue includes an ultrasonic probe configured to perform ultrasonic imaging and ultrasonic treatment of tissue at multiple focal depths, the ultrasonic probe including a transducer module configured to be coupled to the ultrasonic probe, the transducer module including an ultrasonic transducer configured to apply ultrasonic treatment to tissue at multiple locations at the focal depth; a first switch operably controlling an ultrasonic imaging function to provide ultrasonic imaging; a second switch operably controlling an ultrasonic treatment function to provide ultrasonic treatment; a drive mechanism configured to direct the ultrasonic treatment to at least one sequence of a plurality of discrete 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 including a processor and a display for controlling the transducer module.

[0037] In one embodiment, the locations are arranged in a substantially linear sequence within the cosmetic treatment zone. In one embodiment, a first set of the locations are arranged in a first cosmetic treatment zone and a second set of the locations are arranged in a second cosmetic treatment zone, the first zone being different from the second zone. In one embodiment, the first cosmetic treatment zone includes a substantially linear sequence of a first set of the locations and the second cosmetic treatment zone includes a substantially linear sequence of a second set of the locations. In one embodiment, the transducer module is configured to apply the ultrasound treatment using amplitude modulation, where the portions of the transducer module are configured to emit the ultrasound treatment at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. In one embodiment, the transducer module is configured to apply an ultrasound treatment phase shift, where the portions of the transducer module are configured to emit the ultrasound treatment at multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the transducer module is configured to apply the ultrasound treatment using amplitude modulation, where the multiple portions of the transducer module are configured to emit the ultrasound treatment at multiple amplitudes of acoustic intensity, where a first amplitude is different from a second amplitude, and further configured to apply an ultrasound treatment phase shift, where the multiple portions of the transducer module are configured to emit the ultrasound treatment 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 can include a piezoelectric material, where the multiple portions of the transducer module are configured to generate corresponding multiple changes in the piezoelectric material in response to an electric field applied to the transducer module. In one embodiment, the multiple changes in the piezoelectric material include at least one of material expansion and material contraction. In one embodiment, at least a portion of the transducer module can be configured to emit the ultrasound treatment at two or more amplitudes of acoustic intensity, where the amplitude of the ultrasound treatment emitted by at least a portion of the transducer module varies over time.In one embodiment, the drive mechanism is configured to be programmable to provide variable spacing between the multiple individual thermal cosmetic treatment zones. In one embodiment, the sequence of the multiple individual thermal cosmetic treatment zones has a treatment spacing in the range of 0.01 mm to 25 mm. In one embodiment, the first switch and the second switch include a user operated button or key. In one embodiment, at least one of the first switch and the second switch is activated by the control module. In one embodiment, the treatment function is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, vaginal rejuvenation, and acne treatment. In one embodiment, the transducer module can be configured to provide an ultrasonic therapeutic acoustic power in the range of 10 W to 1000 W and a frequency of 1 MHz to 10 MHz to thermally heat tissue to induce coagulation.

[0038] In various embodiments, a multi-focused ultrasound treatment system for simultaneous treatment at multiple depths includes a control device operatively controlling an ultrasound treatment function to provide ultrasound treatment, and a hand wand configured to guide the ultrasound treatment to a sequence of multiple discrete thermal cosmetic treatment zones, the hand wand including a transducer configured to apply ultrasound therapy to tissue at locations at the focal depths, the locations being positioned within the thermal cosmetic treatment zones, the transducer further configured to apply ultrasound therapy to tissue simultaneously at multiple locations at the focal depths.

[0039] In various embodiments, a system for imaging at multiple depths and simultaneous multi-focal treatment includes a module including an ultrasound transducer configured to apply ultrasound therapy to tissue at multiple focal depths with at least one of the group consisting of amplitude modulated polarization and phase shifting, the module further including an interface guide designed to removably couple to a hand wand to provide electronic communication and power between the module and the hand wand.

[0040] In one embodiment, the locations are arranged in a substantially linear sequence within the cosmetic treatment zone. In one embodiment, a first set of the locations are arranged in a first cosmetic treatment zone and a second set of the locations are arranged in a second cosmetic treatment zone, the first zone being different from the second zone. In one embodiment, the first cosmetic treatment zone includes a substantially linear sequence of a first set of the locations and the second cosmetic treatment zone includes a substantially linear sequence of a second set of the locations. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic treatment using amplitude modulation, where the portions of the ultrasonic transducer are configured to emit ultrasonic treatment at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic treatment phase shift, where the portions of the ultrasonic transducer are configured to emit ultrasonic treatment at multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic treatment using amplitude modulation, where multiple portions of the ultrasonic transducer are configured to emit ultrasonic treatment at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude, and further configured to apply ultrasonic treatment phase shift, where multiple portions of the ultrasonic transducer are configured to emit ultrasonic treatment at multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the multiple phases include discrete phase values. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and the multiple portions of the ultrasonic transducer are configured to generate corresponding multiple 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 an expansion of the piezoelectric material and a contraction of the piezoelectric material. In one embodiment, at least a portion of the ultrasonic transducer is configured to emit 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 varies over time. In one embodiment, the imaging and treatment system includes a drive mechanism configured to be programmable to provide spacing between multiple discrete cosmetic treatment zones.In one embodiment, the sequence of discrete cosmetic treatment zones has a treatment interval in the range of 1 mm to 50 mm. In one embodiment, the ultrasound treatment is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, vaginal rejuvenation, and acne treatment. In one embodiment, the ultrasound transducer can be configured to provide an ultrasound therapeutic acoustic power in the range of 1 W to 100 W and a frequency of 1 MHz to 10 MHz to thermally heat tissue to induce coagulation.

[0041] In various embodiments, a treatment system for simultaneous treatment at multiple depths includes a control device operatively controlling an ultrasonic treatment function to provide ultrasonic treatment, and a hand wand configured to guide the ultrasonic therapy to a sequence of multiple discrete thermal cosmetic treatment zones, the hand wand including an ultrasonic transducer configured to simultaneously apply ultrasonic therapy to tissue at multiple locations at a focal depth.

[0042] In various embodiments, a non-physician-performed non-invasive method of performing cosmetic procedures simultaneously at multiple depths includes coupling a transducer module to an ultrasound probe, where the transducer module includes an ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations at a focal depth with at least one of the group consisting of amplitude modulated polarization and phase shifting, and the ultrasound probe includes a first switch for controlling acoustic imaging, a second switch for controlling acoustic treatment to induce multiple discrete cosmetic treatment zones, and a drive mechanism for providing desired spacing between the multiple discrete cosmetic treatment zones; contacting the transducer module against a skin surface of a subject; acoustically imaging an area below the skin surface with the transducer module by activating the first switch on the ultrasound probe; and acoustically treating the area below the skin surface with a desired sequence of multiple discrete cosmetic treatment zones controlled by the drive mechanism by activating the second switch of the ultrasound probe.

[0043] In various embodiments, an ultrasonic treatment system for dithering multiple simultaneous focal points at multiple depths from an ultrasonic transducer includes an ultrasonic probe including an ultrasonic transducer having a single transducer element adapted to simultaneously apply ultrasonic therapy to tissue at multiple spaced apart focal depths, the ultrasonic transducer being polarized with 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, the control module varying the distance between the spaced apart locations via dithering the first and second focal zones, thereby enabling precise movement of the position of the beam focal point at the spaced apart locations via dithering via frequency modulation.

[0044] In one embodiment, the locations are arranged in a linear sequence within the cosmetic treatment zone, with the locations spaced apart from one another being spaced apart by spatial dithering via frequency swing. In one embodiment, a first set of the locations is arranged within a first cosmetic treatment zone, and a second set of the locations is arranged within a second cosmetic treatment zone, with the first zone being different from the second zone. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic treatment using amplitude modulation, where the portions of the ultrasonic transducer are adapted to emit ultrasonic treatment at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. In one embodiment, at least a portion of the ultrasonic transducer is adapted to emit ultrasonic treatment at two or more amplitudes of acoustic intensity, with the amplitude of ultrasonic treatment emitted by at least a portion of the piezoelectric body varying over time. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and the portions of the ultrasonic transducer are adapted to generate corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the changes in the piezoelectric material include at least one of an expansion of the piezoelectric material and a contraction of the piezoelectric material. In one embodiment, the ultrasonic transducer can be adapted to apply ultrasonic therapy via phase shifting, where multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, the first phase being 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, where multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude, and further adapted to apply ultrasonic therapy, where multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, the first phase being different from the second phase.In one embodiment, the ultrasound treatment is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, décolletage improvement, buttocks lift, scar reduction, burn treatment, skin tightening, blood vessel reduction, sweat gland treatment, sun spot removal, fat treatment, abdominal laxity treatment, and cellulite treatment. In one embodiment, the ultrasound probe can include a drive mechanism adapted to guide the ultrasound treatment to at least one pair of simultaneous sequences 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 can include a transducer module adapted to apply ultrasound treatment.

[0045] In various embodiments, an ultrasonic treatment system for use in cosmetic treatment for dithering multiple simultaneous focal points at multiple depths from an ultrasonic transducer includes an ultrasonic probe including a control module adapted to vary the spacing between a first focal zone and a second focal zone via dithering, a switch operably controlling an ultrasonic treatment function to provide ultrasonic treatment, and a drive mechanism adapted to guide the ultrasonic treatment to at least one pair of simultaneous sequences of multiple discrete thermal cosmetic treatment zones, a transducer module adapted to apply ultrasonic treatment, the transducer module adapted to perform both ultrasonic imaging and ultrasonic therapy, adapted to be coupleable to the ultrasonic probe, and including an ultrasonic transducer adapted to apply ultrasonic treatment to tissue at multiple locations having at least two focal depths, the transducer module adapted to be operably coupled to at least one of the switch and the drive mechanism, and a control module including a processor and a display for controlling the transducer module.

[0046] In one embodiment, the transducer module is adapted to apply the ultrasound treatment using amplitude modulation, where the multiple portions of the transducer module are adapted to emit the ultrasound treatment at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. In one embodiment, the transducer module is adapted to apply the ultrasound treatment, where the multiple portions of the transducer module are adapted to emit the ultrasound treatment at multiple phases of acoustic intensity, the first phase being different from the second phase.

[0047] In various embodiments, an ultrasonic treatment system for dithering simultaneous multi-focal treatment at multiple depths includes a module including an ultrasonic transducer adapted to simultaneously apply ultrasonic therapy to tissue at multiple spaced depths within the tissue, the module varies the spacing between the multiple spaced depths via dithering a first focal zone and a second focal zone, thereby enabling precise movement of the position of the beam focus at the multiple spaced depths by dithering with frequency modulation, and the module further includes an interface guide designed to removably couple to a hand wand to provide electronic communication and power between the module and the hand wand.

[0048] In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy using amplitude modulation, where the multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy, where the multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the ultrasonic transducer includes a piezoelectric material, where the multiple portions of the ultrasonic transducer are adapted to generate 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, 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 ultrasound treatment is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, décolletage improvement, buttocks lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, cellulite treatment, abdominal laxity treatment, vaginal rejuvenation, and acne treatment.

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

[0050] In one embodiment, the method further includes imaging the first focal zone with an ultrasound imaging element. In one embodiment, the method further includes imaging the second focal zone with an ultrasound imaging element. In one embodiment, the spacing between the first and second focal zones is dithered in the range of 1% to 50%. In one embodiment, the spacing between the first and second focal zones is 1.5 mm with 0.1 mm increments. 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 face lift, brow lift, chin lift, eye treatment, wrinkle reduction, décolletage improvement, buttocks lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, vaginal rejuvenation, abdominal laxity treatment, and acne treatment.

[0051] In various embodiments, a method for simultaneously dithering a single focused ultrasound beam at multiple depths includes providing an ultrasound probe including a single transducer element and a control module, where the single transducer element 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 for controlling the single transducer element, and varying a size of the focal zone at the tissue by dithering the focal zone via frequency modulation.

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

[0053] In various embodiments, an ultrasonic treatment system for delivering simultaneous multi-focal treatment at multiple depths via an electrostrictive element includes a module including an ultrasonic transducer adapted to simultaneously apply ultrasonic therapy to tissue at multiple spaced depths within the tissue by application of an electrostrictive element, the module varies the spacing between the multiple spaced depths via dithering a first focal zone and a second focal zone, thereby enabling precise movement of the position of the beam focus at the multiple spaced depths via dithering via frequency modulation, and the module further includes an interface guide designed to removably couple to a hand wand to provide electronic communication and power between the module and the hand wand.

[0054] In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy using amplitude modulation, where multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy, where multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the ultrasonic transducer includes a piezoelectric material, where multiple portions of the ultrasonic transducer are adapted to generate 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, 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 ultrasound treatment is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, décolletage improvement, buttocks lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, cellulite treatment, abdominal laxity treatment, vaginal rejuvenation, and acne treatment.

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

[0056] In some embodiments described herein, the procedures are entirely cosmetic and not medical. For example, in one embodiment, the methods described herein do not necessarily have to be performed by a physician, but are 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 will be understood that the methods summarized above and described in more detail below, although they describe specific actions taken by a practitioner, may also include direction of others regarding those actions. Thus, an action such as "dithering the energy beam" includes "directing the dithering of 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 transducer 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, consists essentially of, or consists of one, two, three, or more embodiments of any feature or component disclosed herein. In some embodiments, a feature or component is not included and may be negatively disclaimed from a particular claim such that the system does not have such a feature or component.

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

[0060] The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way. Embodiments of the present invention will become more fully understood from the detailed description and the accompanying drawings. [Brief description of the drawings]

[0061] [Figure 1A] FIG. 1A shows a schematic diagram of an ultrasound system in accordance with various embodiments of the present invention.

[0062] [Figure 1B] FIG. 1B shows a schematic diagram of an ultrasound system in accordance with various embodiments of the present invention.

[0063] [Figure 1C] FIG. 1C shows a schematic diagram of an ultrasound system in accordance with various embodiments of the present invention.

[0064] [Diagram 2] FIG. 2 shows a schematic diagram of an ultrasound system coupled to a region of interest in accordance with various embodiments of the present invention.

[0065] [Diagram 3] FIG. 3 shows a schematic diagram of a portion of a converter according to various embodiments of the present invention.

[0066] [Figure 4] FIG. 4 illustrates a partial cutaway side view of an ultrasound system according to various embodiments of the present invention.

[0067] [Diagram 5] FIG. 5 is a table illustrating focal separations for apertures having different spatial frequencies according to various embodiments of the present invention.

[0068] [Figure 6] FIG. 6 is a plot showing focus separation for apertures having different aperture spatial frequencies in accordance with various embodiments of the present invention.

[0069] [Figure 7] FIG. 7 is a plot showing focus separation for apertures having different aperture spatial frequencies in accordance with various embodiments of the present invention.

[0070] [Figure 8] FIG. 8 shows a schematic representation of aperture polarization with spatial frequency that can be modified by channel excitation according to various embodiments of the present invention.

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

[0072] [Figure 10]FIG. 10 shows a schematic representation of one embodiment of an array transducer with an imaging transducer.

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

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

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

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

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

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

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

[0080] [Figure 18]FIG. 18 shows a schematic diagram of multiple thermal coagulation zones at various depths produced by transducers according to various embodiments of the present invention.

[0081] [Figure 19] FIG. 19 shows a schematic view from the xz plane of multiple thermal coagulation zones at various depths produced by the transducer according to FIG.

[0082] [Figure 20] FIG. 20 shows a schematic view from the yz plane of multiple thermal coagulation zones at various depths produced by a transducer according to FIG.

[0083] [Figure 21] FIG. 21 shows a schematic diagram of multiple thermal coagulation zones at various depths produced by transducers according to various embodiments of the present invention.

[0084] [Figure 22] FIG. 22 shows a schematic view from the xz plane of multiple thermal coagulation zones at various depths produced by the transducer according to FIG.

[0085] [Diagram 23] FIG. 23 shows a schematic view from the yz plane of multiple thermal coagulation zones at various depths produced by a transducer according to FIG.

[0086] [Figure 24] FIG. 24 shows a schematic diagram of multiple thermal coagulation zones at various depths produced by transducers according to various embodiments of the present invention.

[0087] [Diagram 25] FIG. 25 shows a schematic view from the xz plane of multiple thermal coagulation zones at various depths produced by the transducer according to FIG.

[0088] [Figure 26] FIG. 26 shows a schematic view from the yz plane of multiple thermal coagulation zones at various depths produced by the transducer according to FIG.

[0089] [Figure 27] FIG. 27 shows a schematic diagram of multiple thermal coagulation zones at various depths produced by transducers according to various embodiments of the present invention.

[0090] [Figure 28] FIG. 28 shows a schematic view from the xz plane of multiple thermal coagulation zones at various depths produced by the transducer according to FIG.

[0091] [Figure 29] FIG. 29 shows a schematic view from the yz plane of multiple thermal coagulation zones at various depths produced by the transducer according to FIG.

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

[0093] [Diagram 31] FIG. 31 shows a schematic diagram of multiple thermal coagulation zones at various depths produced by transducers according to various embodiments of the present invention.

[0094] [Diagram 32] FIG. 32 shows a schematic view from the xz plane of multiple thermal coagulation zones at various depths produced by the transducer according to FIG.

[0095] [Diagram 33] FIG. 33 shows a schematic view from the yz plane of multiple thermal coagulation zones at various depths produced by the transducer according to FIG.

[0096] [Diagram 34] FIG. 34 shows a schematic diagram of multiple thermal coagulation zones at various depths produced by transducers according to various embodiments of the present invention.

[0097] [Diagram 35] FIG. 35 shows a schematic view from the xz plane of multiple thermal coagulation zones at various depths produced by the transducer according to FIG.

[0098] [Diagram 36] FIG. 36 shows a schematic view from the yz plane of multiple thermal coagulation zones at various depths produced by the transducer according to FIG.

[0099] [Figure 37] FIG. 37 is a plot showing amplitude and DC current corresponding to focal plane focus generated by transducers according to various embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0100] The following description illustrates examples of embodiments and is not intended to limit the invention or its teachings, applications, or uses. It will be understood that corresponding reference characters indicate similar or corresponding parts and features throughout the drawings. The description of the specific examples shown in the various embodiments of the invention is for illustrative purposes only and is not intended to limit the scope of the invention disclosed herein. Moreover, the recitation of multiple embodiments having 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. Furthermore, features in one embodiment (e.g., in one figure) can be combined with the descriptions (and figures) of other embodiments.

[0101] In various embodiments, systems and methods for ultrasonic treatment of tissue are adapted and / or configured to provide cosmetic treatments. In some embodiments, devices and methods are provided for performing ultrasonic therapy at a single focal point or multiple simultaneous focal points, where ultrasonic imaging can be used to confirm sufficient acoustic coupling to the treatment area, thereby improving performance or correlation between movement in a first direction and movement in a second direction during imaging in cosmetic and / or medical procedures. As used herein, in various embodiments, "simultaneous" refers to occurring at the same time or occurring 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 or even at the skin surface, such as the epidermis, dermis, fascia, muscle, fat, and superficial muscular aponeurotic system ("SMAS"), are non-invasively treated with ultrasonic energy. The ultrasound energy can be focused, defocused and / or defocused at one or more treatment points and / or treatment zones to achieve cosmetic and / or therapeutic effects, and can be applied to an area 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 a non-invasive dermatological treatment to tissue through thermal treatment, coagulation, cauterization, and / or tightening. In some embodiments disclosed herein, the non-invasive ultrasound can be used to achieve one or more of the following effects:That is, one or more of the following may be achieved: face lift, brow 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., dimpled or non-dimpled female glenoid lipodystrophy), décolletage improvement (e.g., upper chest), buttocks lift (e.g., buttocks 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, sun spot removal, acne treatment, and acne reduction. In one embodiment, fat reduction is achieved. In various embodiments, reduction of cellulite (e.g., dimple-type or non-dimple-type glenoid lipodystrophy) or improvement of one or more characteristics (e.g., dimples, nodule formation, "orange peel" appearance, etc.) is achieved, for example, by approximately 10%-20%, 20%-40%, 40%-60%, 60%-80%, or more (and overlapping ranges therein) compared to untreated tissue. In one embodiment, the décolletage is treated. In some embodiments, two, three, or more beneficial effects are achieved during the same treatment session and may be achieved simultaneously.

[0102] Various embodiments of the present invention relate to devices or methods for controlling the delivery of energy to tissue. In various embodiments, the various forms of energy can include acoustic, ultrasonic, optical, laser, radio frequency (RF), microwave, electromagnetic, radiative, 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 an ultrasonic energy beam into multiple beams. In various embodiments, the devices or methods can be used to modify the delivery of ultrasonic acoustic energy in any procedure, such as, but not limited to, therapeutic ultrasound, diagnostic ultrasound, ultrasonic welding, any application involving coupling mechanical waves to a subject, and other procedures. In general, 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 at a particular depth can be referred to as the generation of thermal coagulation points (TCPs). In some embodiments, the zones can include points. In some embodiments, the zones are lines, planes, spheres, ellipses, cubes, or other one-dimensional, two-dimensional, or three-dimensional shapes. Thermal and / or mechanical ablation of tissue can 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, the TCPs can be generated in a linear or substantially linear, curved or substantially curved zone or sequence, with each TCP being spaced apart from adjacent TCPs by a treatment distance. 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 a treatment distance. Although 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, treatment times 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 posed by the administration of ultrasound therapy. In various embodiments, the time to form TCPs for cosmetic and / or therapeutic treatments for a desired clinical approach at a target tissue is reduced. In various embodiments, the target tissue is any of, but not limited to, skin, eyelids, eyelashes, eyebrows, 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., for abdominal relaxation), stomach, liver, kidneys, uterus, breast, vagina, prostate, testes, glands, thyroid, viscera, hair, muscle, bone, ligament, cartilage, fat, fat labuli, adipose tissue, subcutaneous tissue, transplanted tissue, transplanted organ, lymphocyte, tumor, cyst, abscess, nerve portion, 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 by reference in its entirety herein.

[0106] System Overview 1A, 1B, and 1C, various embodiments of ultrasound system 20 include a hand wand (e.g., hand piece) 100, a module (e.g., transducer module, cartridge, probe) 200, and a controller (e.g., console) 300. In some embodiments, console 300 includes a communication system (e.g., wifi, bluetooth, modem, etc.) for communicating with others, manufacturers, suppliers, service providers, the internet, and / or the cloud. In some embodiments, cart 301 provides mobility and / or location for system 20 and can include wheels, a surface for writing on or placing items, and / or compartments 302 (e.g., drawers, bins, shelves, etc.) for, for example, storing or organizing items. In some embodiments, cart has a power source, such as a power connection to a battery, and / or one or more cords for connecting power or communications (e.g., Ethernet) to system 20. In some embodiments, system 20 includes 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 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 the 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-sharp HD (high definition) visualization of subcutaneous structures for improved imaging. In one embodiment, the system 20 has multiple treatment channels (e.g., 8 channels) and precision linear drive motors that double treatment accuracy while increasing speed (e.g., by 25%, 40%, 50%, 60%, 75%, 100% or more).Collectively, these features establish one of the most versatile system platforms in the industry while providing the foundational technology for unprecedented future capabilities.

[0107] In various embodiments, the controller 300 may be adapted and / or configured to operate in conjunction with the hand wand 100 and the module 200 and the overall functionality of the ultrasound system 20 . In various embodiments, multiple controllers 300, 300', 300", etc. can be adapted and / or configured to operate with multiple hand wands 100, 100', 100", etc. and / or with multiple modules 200, 200', 200", etc. The controller 300 can include connectivity to one or more interactive graphic displays 310, which can include a touch screen 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 handheld device, on a large screen, on a remote screen). In one embodiment, the graphic display 310 includes a touch screen interface 315 (not shown). In various embodiments, the display 310 sets and displays operating conditions, including the operating status 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, among others, a microprocessor with software and input / output devices, to include systems and devices for controlling electronic and / or mechanical scanning and / or for controlling transducer multiplexing and / or for controlling transducer module multiplexing, to include a system for power transmission, to include a system for monitoring, to include a system for sensing the spatial position of the probe and / or transducer and / or for sensing the transducer module multiplexing, and / or to include 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 a microcontroller, microprocessor, field programmable gate array, computer board, and related components, including, for example, firmware and control software, that may interface with user control, with interface circuitry, with input / output circuitry, and with the system for communication, display, interfacing, storage, documentation, and other useful functions. The system software executing on the system process may be adapted and / or configured to control all initialization, timing, level setting, monitoring, safety monitoring, and all other ultrasound system functions related to achieving user-defined treatment objectives. Additionally, the controller 300 may include various input / output modules, such as switches, buttons, and the like, that may also be suitably adapted and / or configured to control the operation of the ultrasound system 20.

[0108] In one embodiment, the hand wand 100 includes one or more finger activated controllers or switches, such as those shown at 150, 160. In various embodiments, one or more thermal treatment controllers 160 (e.g., switches, buttons) activate and / or deactivate treatment. In various embodiments, one or more imaging controllers 150 (e.g., switches, buttons) activate and / or deactivate imaging. In one embodiment, the hand wand 100 can include a removable module 200. In other embodiments, the module 200 can be non-removable. In various embodiments, the module 200 can be mechanically coupled to the hand wand 100 using a latch or coupler 140. In various embodiments, one or more interface guides 235 can be used to aid in coupling the module 200 to the hand wand 100. The module 200 can include one or more ultrasonic transducers 280. In some embodiments, the ultrasonic transducers 280 include one or more ultrasonic elements. The module 200 may include one or more ultrasonic elements. The hand wand 100 may include imaging only modules, treatment only modules, imaging and treatment modules, and the like. In various embodiments, the ultrasonic transducer 280 may be movable in one or more directions 290 within the module 200. The transducer 280 is coupled to a drive mechanism 400. In various embodiments, the drive mechanism may include zero, 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), to help ensure accurate and repeatable movement of the transducer 280 within the module 200. In various embodiments, the module 200 may include a transducer 280 that may emit energy through an acoustically transparent member 230.In one embodiment, the control module 300 can be coupled to the hand wand 100 via the interface 130, and the graphic user interface 310 can be adapted and / or configured to control the module 200. In one embodiment, the control module 300 can provide power to the hand wand 100. In one embodiment, the hand wand 100 can include a power source. In one embodiment, the switch 150 can be adapted and / or configured to control a tissue imaging function, and the switch 160 can be adapted and / or configured to control a tissue treatment function. In various embodiments, delivery of emitted energy 50 at the appropriate focal depth, in the appropriate distribution, at the appropriate timing, and at the appropriate energy level is provided by the module 200 through the operation controlled by the control system 300 of the transducer 280 to obtain a desired treatment effect by the thermal coagulation zone 550 (e.g., thermal coagulation point, "TCP").

[0109] In one embodiment, the module 200 can be coupled to the hand wand 100. The module 200 can emit and receive energy, such as ultrasonic energy. The module 200 can be electronically coupled to the hand wand 100, including an interface that communicates with the controller 300. In one embodiment, the interface guide 235 can be adapted and / or configured to provide electronic communication between the module 200 and the hand wand 100. The module 200 can include various probe configurations and / or various transducer configurations. For example, the module 200 can be adapted and / or configured as a combined dual mode imaging / treatment transducer, as a combined or co-housed imaging transducer and treatment transducer, as separate treatment probe and imaging probe, and the like. In one embodiment, the controller 300 automatically detects and updates the interactive graphic display 310 when the module 200 is inserted into or connected to the hand wand 100.

[0110] In some embodiments, an access key 320 (e.g., a secure USB drive, key) is connected (e.g., removably) to the system 20 to enable the system 20 to function. In various embodiments, the access key is programmed to be customer specific and provides multiple functions including system security, country / region specific access to treatment guidelines and features, software upgrades, 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, the connectivity provides a way to transfer data between the provider of the system 20 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 done by shipping the access key (e.g., a USB drive) to the customer. In one embodiment, semi-connected model connectivity includes a console that is disconnected from the Internet, but the customer has access to 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 to transfer the data. In one embodiment, fully connected model connectivity includes a console that is wirelessly connected to the Internet using wifi, 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 analytic insights, thereby propelling a customer's cosmetic treatment business to the next level.

[0111] In various embodiments, tissue below or even at the skin surface, such as the epidermis, dermis, subcutaneous tissue, fascia, superficial fascia ("SMAS"), and / or muscle, is non-invasively treated with ultrasound energy. The tissue may also include blood vessels and / or nerves. The ultrasound energy may be focused, unfocused and / or defocused to provide a therapeutic effect and may be applied to a region of interest including at least one of the epidermis, dermis, subcutaneous tissue, fascia, and SMAS. FIG. 2 is a schematic illustration of an ultrasound system 20 coupled to a region of interest 10. In various embodiments, the tissue layer that constitutes the region of interest 10 may be located in any part of the subject's body. In one embodiment, the tissue layer is in the head and face region of the subject. The cross-sectional portion of tissue forming the region of interest 10 includes a skin surface 501, an epidermis layer 502, a dermis layer 503, an adipose layer 505, a superficial fascia 507 (hereinafter "SMAS 507"), and a muscle layer 509. The tissue may also include a subcutaneous tissue 504, which may include any tissue below the dermis layer 503. The combination of these layers may be known collectively as a subcutaneous tissue 510. Also illustrated in FIG. 2 is a treatment zone 525 located below the surface 501. In one embodiment, the surface 501 may be a skin surface of a subject 500. Although an embodiment relating to treatment at a tissue layer may be used as an example herein, the system may be applied to any tissue within the body. In various embodiments, the systems and / or methods may be used with respect to tissues (including, but not limited to, one or a combination of muscle, fascia, SMAS, dermis, epidermis, fat, adipocytes, cellulite, which may be referred to as glenoid lipodystrophy (e.g., non-dimple female glenoid lipodystrophy), collagen, skin, blood vessels, in the face, neck, head, arms, legs, or other areas on or within the body (including body cavities)).In various embodiments, reduction in cellulite (e.g., non-dimple type female glenoid lipodystrophy) is achieved in amounts of 2%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 75%, 80%, 90%, 95%, and any range therein.

[0112] Referring to the illustration in FIG. 2, an embodiment of an 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. FIG. 3 illustrates an embodiment of an 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 for treatment. In one embodiment, the focal depth 278 is fixed for a given transducer 280. In one embodiment, the focal depth 278 is variable for a given transducer 280. In one embodiment, the transducer 280 is configured to simultaneously treat at multiple depths below the skin surface (e.g., 1.5 mm, 3.0 mm, 4.5 mm, or other depths).

[0113] Referring to the illustration in FIG. 4, the module 200 can include a transducer 280 that can emit energy through the acoustically transparent member 230. In various embodiments, the depth can refer to a focal depth 278. In one embodiment, the transducer 280 can have an offset distance 270 that 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 can 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 at a location 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 at a target area located at a tissue depth 279 below the skin surface 501. In various embodiments, when the ultrasound system 20 is placed in physical contact with the skin surface 501, the tissue depth 279 is the distance between the acoustically transparent member 230 and the target area, measured as the distance from the surface portion of the hand wand 100 or module 200 in contact with the skin (with or without acoustic coupling gel, medium, etc.) and the depth in the tissue from the contact point on the skin surface to the target area. In one embodiment, the focal depth 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 coupling medium and / or skin 501) and the tissue depth 279 below the skin surface 501 to the target area. In various embodiments, the acoustically transparent member 230 is not used.

[0114] The coupling member may include various 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. An acoustic coupling system with possible connecting members such as a manifold may be utilized to couple sound into the region of interest and provide liquid or fluid-filled lens focusing. The coupling system may facilitate such coupling through 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 allows signal transmission across 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 a housing. In one embodiment, the fluid-filled module 200 contains one or more coupling media inside a sealed housing that is separable from the dry portion of the ultrasonic device. In various embodiments, the coupling medium can be used to transmit ultrasonic energy between one or more devices and tissue with a transmission efficiency of 100%, 99% or more, 98% or more, 95% or more, 90% or more, 80% or more, 75% or more, 60% or more, 50% or more, 40% or more, 30% or more, 25% or more, 20% or more, 10% or more, and / or 5% or more.

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

[0116] In various embodiments, varying the number of focal positions (e.g., with tissue depth 279, etc.) for an ultrasound procedure can be advantageous to allow treatment of the patient 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 results of a single treatment session. For example, treatment at multiple depths below a single surface area allows for a larger total volume of tissue treatment, thereby resulting in improved collagen formation and tightening. In addition, treatment at various depths affects different types of tissue, thereby generating different clinical effects that together result in an improved overall cosmetic outcome. For example, superficial treatment can reduce the visibility of wrinkles, while deeper treatment can induce the formation of more collagen proliferation. Similarly, treatment at various locations at the same depth or at different depths can improve treatment.

[0117] Although treatment of a subject at different locations in one session may be advantageous in some embodiments, sequential treatment over time may be beneficial in other embodiments. For example, a subject may be treated at a first depth at a first time, at a second depth at a second time, etc., under the same surface area. In various embodiments, the time may be on the order of nanoseconds, microseconds, milliseconds, seconds, minutes, hours, days, weeks, months, or other time periods. New collagen generated by a first treatment may be more susceptible to subsequent treatments, which may be desirable for some indications. Alternatively, treatment at multiple depths under the same surface area in 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, stimulation of growth factors, hormone promotion, etc.). In some embodiments, different transducer modules provide treatment at different depths. In one embodiment, a single transducer module can be adjusted or controlled for a variety of depths, a safety feature to minimize the risk of an incorrect depth being selected that may be selected in conjunction with a single module system.

[0118] In some embodiments, methods are provided for treating the lower face and neck regions (e.g., submental area). In some embodiments, methods are provided for treating (e.g., softening) the mentolavicular fold. In other embodiments, methods are provided for treating the eye region (e.g., treating cheek pouches, infraorbital sagging). Improvement of upper eyelid sagging and improvement of periorbital lines and texture are achieved by some embodiments by treating at variable depths. Optimal clinical effects (e.g., softening, tightening) can be achieved by treating various locations in a single treatment session. 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 treatment sequences at the skin surface or at a fixed depth below the skin surface. In one embodiment, the transducer module enables treatment sequences at one, two or more variable or fixed depths below the dermis layer. In some embodiments, the transducer module includes a drive mechanism adapted and / or configured to guide the ultrasound treatment to a sequence of multiple discrete thermal lesions (hereinafter "thermal coagulation points" or "TCPs") at a fixed focal depth. In one embodiment, the sequence of individual TCPs has a treatment spacing ranging from about 0.01 mm to about 25 mm (e.g., 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 5 mm, 10 mm, 20 mm, and any range therein) with a dithering change of spacing from 1% to 50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, and any range therein). For example, the spacing can be 1.1 mm or less, 1.5 mm or more, about 1.1 mm to about 1.5 mm, etc. In one embodiment, the individual TCPs are discrete from one another. In one embodiment, the individual TCPs overlap one another. In one embodiment, the drive mechanism is adapted and / or configured to be programmable to provide variable spacing between the individual TCPs. In an embodiment, the dithering can be adapted and / or configured to provide variable spacing between the individual TCPs. In some embodiments, the transducer module includes a drive mechanism adapted and / or configured to guide the ultrasonic treatment in a sequence such that the TCPs can be formed in a linear or substantially linear sequence spaced apart from one another by a treatment distance. For example, the transducer module can be adapted and / or configured to form the TCPs along a first linear sequence and along a second linear sequence spaced apart from the first linear sequence by a treatment distance. In an embodiment, the treatment distance between adjacent linear sequences of individual TCPs is within a range of about 0.01 mm to about 25 mm.In one embodiment, the treatment distance between adjacent linear sequences of individual TCPs is in the range of about 0.01 mm to about 50 mm. For example, the treatment distance can be 2 mm or less, 3 mm or less, about 2 mm to about 3 mm, etc. In some embodiments, the transducer module can include one or more drive mechanisms 400 adapted and / or configured to guide the ultrasonic treatment in a sequence such that TCPs can be formed in a linear or substantially linear sequence of individual thermal lesions spaced apart from other linear sequences by the 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 a direction opposite to the first direction 290 (e.g., pull). In one embodiment, the treatment is applied in both the first direction 290 and opposite to the first direction (e.g., push and pull). In one embodiment, the treatment distance separating the linear or substantially linear sequences of TCPs is the same or substantially the same distance. In one embodiment, the treatment distance separating the linear or substantially linear TCPs sequences is different or substantially different distances for different adjacent pairs of linear TCPs sequences.

[0120] In one embodiment, first and second removable transducer modules are provided. In one embodiment, each of the first and second transducer modules are adapted and / or configured to enable both ultrasound imaging and ultrasound treatment. In one embodiment, the transducer modules are adapted and / or configured to enable treatment only. In one embodiment, the imaging transducer can be attached to a handle of a probe or hand wand. The first and second transducer modules are adapted and / or configured to be interchangeably coupled to the 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 FIG. 3, in various embodiments, delivery of emitted energy 50 at the appropriate focal depth 278, in the appropriate distribution, at the appropriate timing, and at the appropriate energy level is provided by the module 200 through controlled operation by the control system 300 to achieve the desired therapeutic effect of controlled thermal damage to treat at least one of the epidermis layer 502, the dermis layer 503, the fat layer 505, the SMAS layer 507, the muscle layer 509, and / or the subcutaneous tissue 504. FIG. 3 illustrates one embodiment of a depth corresponding to a depth for treating muscle. In various embodiments, the 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. In operation, the module 200 and / or the transducer 280 can also be mechanically and / or electronically scanned along the surface 501 to treat an extended area. Before, during, and after delivery of ultrasound energy 50 to at least one of the epidermis layer 502, the dermis layer 503, the subcutaneous tissue 504, the fat layer 505, the SMAS layer 507, and / or the muscle layer 509, monitoring of the treatment area and surrounding structures can be performed to allow planning and evaluation of the monitoring results, and feedback can be provided to the controller 300 and, via the graphical interface 310, to the user.

[0122] In one embodiment, the ultrasonic system 20 generates ultrasonic energy that is directed toward and focused below the surface 501. Such controlled and focused ultrasonic energy 50 generates thermal coagulation points or zones (TCPs) 550. In one embodiment, the ultrasonic energy 50 generates voids in the subcutaneous tissue 510. In various embodiments, the emitted energy 50 targets tissue below the surface 501 to cut, cauterize, coagulate, microcauterize, manipulate, and / or generate TCPs 550 at a designated focal depth 278 within the tissue portion 10 below the surface 501. In one embodiment, during a treatment sequence, the transducer 280 moves in a direction indicated by the arrow labeled 290 at a designated interval 295 to generate a sequence of treatment zones 254, each configured by receiving the emitted energy 50 to generate one or more TCPs 550. In one embodiment, the arrow labeled 291 indicates an axis or orientation that is perpendicular or parallel to the arrow 290, and the spacing of the TCPs 550 indicates that the TCPs may be spaced perpendicular or parallel to the direction of movement of the transducer 280. In some embodiments, the orientation of the spaced TCPs may be any angle between 0 degrees and 180 degrees from the arrow 290. In some embodiments, the orientation of the spaced TCPs may be any angle between 0 degrees and 180 degrees based on the orientation of the polarized regions on the transducer 280.

[0123] In various embodiments, the transducer module may include one or more transducer elements. The transducer elements may include a piezoelectrically active material, such as lead zirconate titanate (PZT), or any other piezoelectrically active material, such as piezoelectric ceramics, crystals, plastics, composites, or the like, as well as lithium niobate, lead titanate, barium titanate, lead metaniobate, or the like. In various embodiments, in addition to or instead of a piezoelectrically active material, the transducer module may include any other material adapted and / or configured to generate radiant and / or acoustic energy. In various embodiments, the transducer module may be adapted and / or configured to operate at different frequencies and at different treatment depths. The transducer characteristics include an outer diameter ("OD") and a focal length (F). L In one embodiment, the transducer has an OD=19 mm and F L In other embodiments, the OD and F may be adapted and / or configured to have OD and F = 15 mm. L Other suitable values ​​for F may be used, such as an OD less than about 19 mm, an OD greater than about 19 mm, etc., and an F of less than about 15 mm. L , F greater than about 15 mm L, etc., may be used. The transducer module may be adapted and / or configured to apply ultrasonic energy at different target tissue depths. As described above, in some embodiments, the transducer module includes a drive mechanism adapted and / or configured to guide the ultrasonic treatment to create a linear or substantially linear sequence of individual TCPs with 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 the ultrasonic treatment to create a sequence such that the TCPs are formed in a linear or substantially linear sequence spaced apart by the treatment interval. For example, the transducer module may be adapted and / or configured to create TCPs along a first linear sequence and along a second linear sequence spaced apart from the first linear sequence by a treatment interval of about 2 mm to 3 mm. In one embodiment, a user may manually drive the transducer module over a surface of the treatment area such that adjacent linear sequences of TCPs are created. In one embodiment, a drive mechanism can automatically drive the transducer module over the surface of the treatment area such that multiple adjacent linear sequences of TCPs can be generated.

[0124] Aperture spatial frequency analysis and Fourier transform In various embodiments, the efficiency of therapeutic procedures can be improved by using spatial frequency analysis techniques based on Fourier analysis and Fourier optics. When a system with an impulse response h(t) is excited by a stimulus x(t), the relationship between the input x(t) and the output y(t) is related by a convolution function as follows:

number

[0125] In various embodiments, a Fourier transform may be applied in computing the convolution in equation (1). A continuous one-dimensional Fourier transform may be defined as follows:

number

[0126] where 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 the transducer aperture and the resulting ultrasound beam response. The derivation of the Fraunhofer approximation is described in Joseph Goodman, Introduction to Fourier Optics (3d 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, since a linear wave equation can be used to describe both light and sound propagation. In the case of optics and / or ultrasound, a two-dimensional Fourier transform can determine the acoustic pressure amplitude distribution at the transducer focus.

[0128] In the case of a focused system, the variable z, which indicates the depth, is proportional to the focal length z f can be replaced by:

number

[0129] In various embodiments, Fourier optics and Fourier transform identities, some of which are listed in Table 1 below, can be used for an ultrasonic transducer 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 of uniform amplitude is a first order Bessel function, which can be expressed as J1. [Table 1] Table 1

[0130] In some embodiments, the ultrasonic transducer can have a rectangular aperture with suitable dimensions and suitable focal length. In some embodiments, the ultrasonic transducer can have a circular aperture with suitable dimensions and suitable focal length. In one embodiment, the transducer can have a circular aperture with an outer diameter of about 9.5 mm, an inner diameter of about 2 mm, and a focal length of about 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" may be approximately 9.5 mm and the variable "b" may be approximately 2 mm. By applying a Fourier transform to equation (5a), an estimate of the acoustic pressure distribution at the focal point can be obtained.

number

[0132] In the formula, ξ x and ξ y is f in formulas (4a) and (4b) x and f yEquation (6) shows that the acoustic pressure distribution of a transducer with a circular aperture is a first order Bessel function. In one embodiment, a substantial majority of the energy is concentrated at the focal point (e.g., 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 produced at the focal point if the aperture is modulated (e.g., multiplied) by the appropriate 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 focus of the modulated aperture in equation (7) is the convolution of the Fourier transform of the two functions of the aperture.

number

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

number

[0136] Equation (9) shows that the two beams appearing at the focal points are spatially shifted by ±c / (2π) compared to the original unmodulated beam. In some embodiments, one or more other modulation functions, such as a sine function, can be used to obtain the desired beam response. In some embodiments, the aperture can be modulated such that more than two focal points are generated. For example, three, four, five, etc. focal points can be generated. In some embodiments, the aperture can be modulated such 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 the ultrasonic treatment to form a linear or substantially linear sequence of individual TCPs with a treatment interval between the individual TCPs. For example, the treatment interval can be about 1.1 mm, 1.5 mm, etc. In some embodiments, the transducer module can further include a drive mechanism configured to guide the ultrasonic treatment to form a sequence such that the TCPs are formed in a linear or substantially linear sequence spaced apart by the treatment interval. For example, the transducer module can be configured to form the TCPs along a first linear sequence and along a second linear sequence spaced apart from the first linear sequence by a treatment interval of about 2 mm to 3 mm. According to equation (9), a simultaneous or substantially simultaneous splitting of the ultrasound 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 the desired spatial frequency. In one embodiment, two simultaneously or nearly simultaneously focused beams spaced apart by a treatment interval of about 1.1 mm can be generated in a linear or substantially linear sequence. At an ultrasound frequency of 7 MHz, the wavelength λ of ultrasound in water is about 0.220 mm. Thus, the spatial frequency ξ at the focal point x and ξ y is expressed as follows:

number

[0138] To place two foci approximately 1.1 mm apart, 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 argument:

number

[0139] In one embodiment, formula (11a) is expressed as follows: x can be solved.

number

[0140] Additionally, x0 can be replaced by half the separation distance (eg, 1.1 mm).

number

[0141] In some embodiments, a transducer having a circular aperture emitting ultrasonic energy at various operating frequencies can be modulated by sine and / or cosine functions at the spatial frequencies listed in Table 2. The modulated aperture of the transducer can generate simultaneous or substantially simultaneous split beams with two focal points spaced apart by different distances as shown in Table 2. In one embodiment, the transducer can 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 ultrasound operating frequency increases for a given focal separation. In addition, the spatial frequency increases as the desired focal separation increases.

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

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

number

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

number

[0146] In one embodiment, the aperture modulation of equations (12) and (13) that allows the beam to be placed at multiple locations simultaneously or nearly simultaneously may be limited in applicability due to system limitations, material limitations, and / or tissue limitations. In one embodiment, the frequency of the ultrasound treatment may be adjusted, such as lowered, to limit and / or eliminate the possibility of heating the treatment area tissue located in front of the focal point. In one embodiment, nonlinear techniques may be applied at 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, the acoustic pressure or ultrasound intensity from the aperture may be increased to obtain a similar or substantially similar intensity at the focal plane.

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

[0148] Electronic dithering of multiple beamsplitting apertures using frequency modulation. In various embodiments, Table 2 shows the aperture spatial frequency to obtain a particular distance between two simultaneous focal points for a given operating frequency (e.g., in various embodiments, 4 MHz, 7 MHz, 10 MHz). Equation (11c) shows that the separation between the focal points is also a function of the operating frequency. For example, in one embodiment, the spatial frequency of the aperture (k x ) is 1.0mm -1 and the operating frequency is allowed to vary. Equation 11c can be rewritten to show how the focal separation can be modulated through the operating frequency.

number

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

number

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

number

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

[0152] As shown in Table 3, as the operating frequency increases the focal points move closer together and as the operating frequency decreases the focal points move farther apart without the need to change phase or mechanically move the transducer. This is a unique method in which the beam can be electronically moved to spread the energy without relying on thermal conduction in the tissue. Advantages include reducing or minimizing maximum temperature and increasing the thermal coagulation volume of the lesion without requiring additional system channels.

[0153] The amount of 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 FIG. 5 shows the displacement of the aperture at different spatial frequencies (k x =0.5mm -1 , 1.0mm -1 , 1.5mm -1 , 2.0mm -1 ) is shown. The spread from the focus for 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] The spacing difference for all operating frequencies of the apertures for different aperture spatial frequencies is shown in Figure 6. As shown in Figure 6, the separation distance increases as the frequency decreases.

[0155] In one embodiment, the separation is relative to the frequency of 5 MHz. In one embodiment, one way to estimate electronic dithering from frequency modulation can be determined by looking at all the movements to the initial separation at 5 MHz. As shown in FIG. 7, the spread of the separation between the foci can easily vary by more than 1 mm.

[0156] In various embodiments, the range of possible operating frequencies from an aperture can be described in terms of the bandwidth of the transducer. In one embodiment, a larger bandwidth of the transducer results in an aperture with a wider range of operating frequencies. The bandwidth of the transducer can be described as a percentage of the aperture center frequency by identifying the frequency at which the transmit power falls off to -3 dB of the peak transmit power. In one embodiment, the -3 dB high frequency for the transmit response of the transducer aperture is f -3dB,H The low frequency of -3 dB is f -3dB,L The -3dB center frequency in [MHz] is written as follows:

number

[0157] The -3 dB percent bandwidth is written as:

number

[0158] In some embodiments, an increased range of possible operating frequencies within an aperture can be obtained 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, the range of possible separation distances increases as the bandwidth of the transducer increases. Table 5 (below) shows how the spread of the foci can vary based on the percentage of bandwidth when the aperture center frequency is 5 MHz. The separation between the foci at 5 MHz is 0.5 mm. -1 , 1.00mm -1 , 1.50mm -1 , 2.00mm -1 The spatial frequencies at the aperture are 0.72 mm, 1.43 mm, 2.15 mm, and 2.86 mm, respectively. -1 and the transducer bandwidth is 60%, the separation between the foci changes by 1.42 mm, which is greater 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 will also change along with the lateral resolution and focal gain. In one embodiment, as the frequency is changed, the depth of field, lateral resolution, and focal gain will also change. Thus, in one embodiment, the intensity at the aperture can be changed depending on the heating rate target. Also, in some embodiments, it may be advantageous to transmit multiple operating frequencies simultaneously to spread the energy instantly or nearly instantly. For example, transmit excitation of the aperture can include excitation at 4 MHz, 5 MHz, and 6 MHz all at the same time.

[0160] Multiple focal points by changing the spatial frequency of the aperture As Equation 14 indicates, the greater the spatial frequency of the aperture, the greater the separation between the foci. In one embodiment, the aperture has a spatial frequency k x As shown in the embodiment of FIG. 8, the spatial frequency can be easily doubled or reduced to zero by connecting multiple individual electrical excitation channels with the ability to change the phase to either 0 or 180 degrees. For example, if channels 1-16 have a phase of 0 degrees, the aperture spatial frequency is k x In one embodiment, as the phase of each channel varies from 0 to 180 degrees, with the odd channels at 0 degrees and the even channels at 180 degrees, the spatial frequency at the aperture is 1 / 2k x In one embodiment, if the phase is repeated for every two channels, such that channel 1 and channel 2 are 0 degrees, channel 3 and channel 4 are 180 degrees, etc., then the spatial frequency at the aperture is 0. If channel 1 is 0 degrees, channel 2 is 180 degrees, channel 3 is 180 degrees, channel 4 is 0 degrees, etc., then the spatial frequency at the aperture is 2k x In this case, seven unique foci can be generated. As described in Table 4 (Figure 5), if the center frequency of the aperture is 5 MHz and the aperture frequency is 0 mm, -1 , 0.5mm -1 , 1.0mm -1 , or 2.0 mm -1 If either of the above is true, the corresponding separation distances are 0 mm, 0.72 mm, 1.43 mm, and 2.86 mm, resulting in seven unique focal positions spaced 0.36 mm apart. In various embodiments, intermediate phases between 0 and 180 degrees allow the two focal points to be tilted further so that a line of multiple foci can be generated at the focal plane. Finally, the tilt, modulation of focal position, and frequency modulation allow heating and possible solidification of the entire line having a length of approximately 2.86 mm.

[0161] In one embodiment, the poled ceramic is 2k xIn this case, each electrical channel covers two polarized regions in a ceramic (e.g., a piezoelectric ceramic). If channels 1 to 8 have the same electrical phase as each other, the spatial frequency of the aperture is 2k x If the phase is alternating, such that the odd channels have a phase of 0 degrees and the even channels have a phase of 180 degrees, then the spatial frequency of the aperture is k x In one embodiment, this configuration allows for four unique focal points, with only two phases allowed on the channels. In various embodiments, the two focal points can be tilted to many different focal positions if additional phases are allowed. This configuration limits the number of electronic channels required to achieve 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 allows faster electronic dithering to generate more thermal coagulation using the same amount of energy as other treatment devices, or to generate equivalent thermal coagulation using electronic dithering with less energy than other treatment devices. This technique widens the continuum of efficacy and comfort that the device provides. In addition to electronic dithering, multiple treatment channels also provide the possibility to move the beam to different depth positions, so that a conventional two-transducer such as DS7-4.5 (7MHz at 4.5mm depth) and DS7-3.0 (7MHz at 3.0mm depth) can be replaced with a single device that moves between two different depths.

[0163] In one embodiment, a transducer 280 (e.g., an annular array) with multiple treatment channels 281 connected to drive the beam axially typically creates TCPs 550 at a deep depth first and then moves to a shallower depth. In other embodiments, TCPs 550 are created below the skin surface at a shallow depth and then at a deeper depth. This results in sequential creation of TCPs 550 and extended treatment times. For example, in one embodiment, the time for a deep TCP 550 is set to t deep , time for shallow TCP550 t shallow Then, the total treatment time for the two TCPs550 is the sum of the two treatment times, i.e., t deep Plus T shallow In one embodiment, the total treatment time is reduced by forming multiple (two or more) TCPs 550 simultaneously using a signal mixing technique that uses both signal apodization (shading) and phase control in each channel. In one embodiment, the total treatment time is reduced by t deep and t shallow The larger of these values.

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

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

[0166] In one embodiment, the annular array design 280 allows for electronic movement of the treatment beam in depth (e.g., by varying the depth of the TCP 550 below the skin surface). In one embodiment, the transducer 280 includes eight treatment channel annular transducer elements 281 with a fixed mechanical focus. FIG. 10 shows a top view of one embodiment of this ceramic annular array design 280 with an imaging transducer 285 at the center of the bowl. In this embodiment, the treatment annular transducer 280 has eight rings identified as Tx0-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 with 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 with one, two, three, four, or more simultaneous focal zones, with any one or more of the features that provide variable depth, variable spacing, variable focal 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, the one or more tuning circuits are located within the housing of the transducer and / or within the connection between the transducer and the console and / or within the console.

[0168] FIG. 11 shows an embodiment of a transducer 280 including a single element with a convex surface 282 and a concave surface 283. FIG. 12 shows an embodiment of a transducer 280 including a smooth coated convex surface 282 and a striped concave surface 283, where the stripe includes a first and a second polarization region, where the polarization region is positively polarized, negatively polarized, or unpolarized. FIG. 12 shows an embodiment of a transducer 280 including a smooth coated convex surface 282 and a striped concave surface 283, where the stripe includes a first and a second region, where the region may or may not include a coating. In an embodiment, a single electrode is provided on the convex surface and the polarization stripes on the concave surface are connected to two channels (e.g., FIG. 12). The stripes may be alternating to split the beam or may include only one phase to mimic a conventional transducer. This allows one converter to mimic the DS4-4.5S and DS4-4.5 procedures, allowing three lines to be generated with one converter arrangement.

[0169] FIG. 13 shows an embodiment of a transducer 280 including a striped convex surface 282 and a smooth coated concave surface 283, where the stripes include a first and a second polarization region, where the polarization region is positively polarized, negatively polarized, or unpolarized. FIG. 13 shows an embodiment of a transducer 280 including a striped convex surface 282 and a smooth coated concave surface 283, where the stripes include a first and a second region, where the regions may or may not include a coating. In various embodiments, the stripes are electrically connected to one or more channels. In one embodiment, the odd numbered stripes are connected to the first channel and the even numbered stripes are connected to the second channel. In one embodiment, the first channel remains at 0° while the second channel alternates between 0° and 180° (or conversely, the first channel alternates between 0° and 180° while the second channel remains at 0°). The focused ultrasound energy from the first channel remains at a single central location, while the focused ultrasound energy from the second (alternating) channel creates two focal zones spaced apart from each other. Together, the focused ultrasound energy from the first (constant) and second (alternating) channels creates three simultaneous TCPs. In one embodiment, a single electrode is provided on the concave surface, and polarized stripes on the convex surface are connected to the two channels (e.g., FIG. 13). The stripes can be alternating to split the beam, or can include only one phase to mimic a conventional transducer. This allows the DS4-4.5S and DS4-4.5 procedures to be mimicked by one transducer, which allows the creation of three lines with one transducer arrangement.

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

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

[0172] 16 shows an embodiment of a transducer 280 including an annular convex surface 282 and a striped concave surface 283, the stripe including first and second polarization regions, the polarization regions being positively polarized, negatively polarized, or unpolarized. FIG 16 shows an embodiment of a transducer 280 including an annular convex surface 282 and a striped concave surface 283, the stripe including first and second regions, the regions 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, consists essentially of, or consists of a single ultrasound transducer element configured to provide two simultaneous treatment zones via dithering. In alternative embodiments, multiple features or components are provided.

[0174] Simultaneous treatment at multiple depths In various embodiments, the treatment system is configured to generate multiple microcoagulation regions in tissue that are equidistantly spaced along a line of mechanical movement. In various embodiments, the treatment system provides various modules, or cartridges, or 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" on 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 25mm line, while the slim transducer provides a maximum line length of 14mm.). In various embodiments, a transducer with annular electrodes and poled ceramics allows frequency dithering in the lateral dimension, electronic dithering in the depth dimension, electronic focusing in the depth dimension, and a single transducer that can mimic the DS10-1.5 (10 MHz at 1.5 mm depth), DS7-3.0 (7 MHz at 3.0 mm depth), DS7-4.5 (7 MHz at 4.5 mm depth), and DS4-4.5 (4 MHz at 4.5 mm depth) with one transducer. In one embodiment, selectable tuning electronics can be used in combination with the composite ceramic to enable the functionality of a transducer with annular electrodes and poled ceramics that allows 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 help stabilize the signal between the console and the transducer and can be present within the transducer housing, between the transducer and the console, or within the console.

[0175] In one embodiment, in a full face treatment, the transducer delivers 800 treatment lines as the operator moves the handpiece along the patient's skin over a period of approximately 70-90 minutes. In one embodiment, a single treatment bowl is configured for simultaneous delivery of two treatment lines (e.g., DS4-4.5S, DS4-3.0S, OT4-4.5S, or OT4-3.0S), which can reduce treatment delivery time by approximately 40% based on recent clinical trials. In various embodiments, the treatment device provides a similar level of efficacy when operated with the correct energy. In various embodiments, the simultaneous treatment reduces the overall pain of the treatment. In one embodiment, it is envisioned that the simultaneous treatment time is significantly reduced and the overall pain of the treatment is less.

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

[0177] In one embodiment, the simultaneous treatment system creates two lines simultaneously with the ability to move the microcoagulation depth at the thermal coagulation zone 550. In one embodiment, the bandwidth of the therapeutic transducer is increased, allowing one device to operate like two, three, four, five, or six fixed depth devices. In one embodiment, an eight channel therapeutic device is used.

[0178] FIG. 17 shows an embodiment of a transducer 280 including an annular convex surface 282 and a striped concave surface 283, where the stripe includes a first and a second polarization region, where the polarization region is positively polarized, negatively polarized, or unpolarized. FIG. 17 shows an embodiment of a transducer 280 including an annular convex surface 282 and a striped concave surface 283, where the stripe includes a first and a second region, where the region may or may not include a coating. In one embodiment, an annular array coupled to a simultaneous transducer delivers two lines of focused ultrasound treatment below the skin surface at different depths 279 (e.g., D1, D2, D3, ... D4). N) simultaneously. 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 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, more than 4.5 mm, more than 6 mm, 7 mm, and any range 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, and 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 creates multiple thermal coagulation zones 550 at various depths 279. FIG. 17 shows two sides of one embodiment of a simultaneous treatment bowl. On one side of the treatment bowl are stripes used to perform alternating polarization. In one embodiment, the stripes are on a concave surface 283. In one embodiment, the stripes are on the convex surface 282. In one embodiment, after poling, the electrodes are removed and a complete electrode is placed on the entire surface. In one embodiment, the stripes can be connected by using cold silver electrodes. In one embodiment, the opposite surface of the treatment bowl contains multiple concentric rings that can be of equal or unequal area. The annular array allows for beam movement in depth when the proper phasing is applied to the treatment bowl.

[0179] In one embodiment, a transducer 280 with an annular convex surface 282 and a striped concave surface 283 is configured to generate multiple depths of thermal coagulation zones 550 at various depths 279 as shown in FIG. 18 (projection in xyz space), FIG. 19 (xz plane), and FIG. 20 (yz plane). FIG. 18 shows a three-dimensional sketch of micro-coagulation points. 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 envisioned that a deeper micro-coagulation point is generated first (e.g., 4.5 mm), then moves to the next depth (e.g., 3.0 mm), and then moves 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, the skin temperature can be limited by forming a micro-coagulation point at the deepest depth (e.g., 4.5 mm) when moving from left to right, then by placing it at the next depth (e.g., 3.0 mm) when moving from right to left, and then completing the treatment with a micro-coagulation point at the shallowest depth (e.g., 1.5 mm) when moving again from left to right. Figure 19 shows the projection of the treatment along the mechanical movement direction (x-axis) and the depth direction (z-axis). Figure 20 shows the projection of the treatment along the beam split direction (y-axis) and the depth direction (z-axis).

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

[0181] 24-26 show an 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 shallow depths by a variable pitch. In an embodiment, a drive mechanism can be used to match the spacing between TCPs in a single line treatment. FIG. 24-26 show a three-dimensional sketch of simultaneous treatment at multiple depths. In this case, in an embodiment, the treatment at 4.5 mm depth is delivered at one pitch (1.5 mm spacing), while the treatment at 3.0 mm depth and the treatment at 1.5 mm depth are delivered at another pitch (e.g., 1.1 mm spacing). Although the treatment at 1.5 mm depth and the treatment at 3.0 mm depth have the same pitch (e.g., 1.1 mm), the drive mechanism can apply an offset to prevent stacking of micro-coagulation points. Figure 25 shows the projection of the delivery along the mechanical translation (x-axis) and the depth (z-axis). It clearly shows that the middle layer of TCPs is offset from the shallower treatments, even though 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 the 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 with an annular convex surface 282 and a striped concave surface 283 (as shown in FIG. 16 and / or FIG. 17) generates the treatment pattern shown in the embodiment of FIG. 25, FIG. 26, and / or FIG. 29. In one embodiment, a transducer 280 with 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 (such as FIG. 18 and FIG. 19), where the control of each ring in the annular convex surface 282 has an amplitude (A) and a phase (θ). In this case, the stripe-based polarization generates multiple simultaneous foci at one depth. As shown in FIG. 18 and FIG. 19, a different phase (θ) and a different amplitude (A) can be applied to each ring to generate multiple simultaneous foci at each depth, thereby generating multiple simultaneous foci at different depths. Different phases allow the two focal points to move to different focal depths, and different amplitudes allow the focal strength to be changed, thereby changing the heating rate in the tissue. The separation of two focal points at the same depth along the Y axis is determined by the frequency, focal depth, and the spatial frequency of the stripes (see Eq. 14 when solved for s). The transducer can be manually driven or mechanically driven, allowing the simultaneous focal points to be precisely spaced along the X axis. In one embodiment, the amplitude A1 of the middle ring is greater than the amplitude A2 of the next outer ring, which is greater than the amplitude A3, ..., the amplitude A of the outermost ring. n This amplitude is greater than 1000 Hz, which provides a wider intensity range and shaping capabilities for the two simultaneous foci. This control of the amplitude allows one to vary the beam width at the two foci, as well as the intensity, which affects the heating rate.

[0183] In various embodiments, the use of a continuous wave function allows simultaneous focal zones to be generated at different depths below the skin surface while combining the excitation function for the focal solution with other solutions. 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 focal points at different depths (d1 and d2) can be generated simultaneously through a linear system combining excitations to a single ultrasonic transducer. The table below shows the two sets of amplitudes and phases required for each focal zone and depth. In order for these two excitations to occur at the same frequency, the two excitations on each ring can be combined to one amplitude and one phase. Assume that the excitation on ring number 1 for focal point #1 is written as follows:

number

[0184] Assume that the excitation on ring number 1 for focal point #2 is written as follows:

number

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

number

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

number

[0187] Therefore, the new excitation on ring 1 is

number

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

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

[0190] 27-29 show an 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 intermediate layers offset from the shallow depths, and frequencies used to generate different separations at each depth. In FIGS. 24-26, the intermediate depths of the TCPs are offset from the deepest depth and from the shallowest depth using a driving mechanism. In various embodiments, the amount of separation between the simultaneously generated TCPs depends on the treatment frequency. In one embodiment, the device can deliver therapy at multiple frequencies (e.g., using a broadband therapeutic transducer) and the frequency can be used to modulate the distance between the TCPs. As described with respect to FIG. 18, the spacing of the stripes is determined at the time of manufacture for generation through ceramic polarization. Smaller frequencies and deeper depths result in larger separations (in the yz plane) between the 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 treatment depth decreases, the distance between simultaneously generated TCPs decreases. Figure 28 shows the projection of the delivery along the mechanical movement (x-axis) and along the depth (z-axis). This clearly shows that the intermediate layers of TCPs are offset from the shallow treatment and from the deep treatment, even though the pitch is the same. Figure 29 shows the projection of the delivery along the direction in which the beam is split (y-axis) and along the depth direction (z-axis). This projection shows that the spacing between TCPs gradually increases as the treatment depth increases, mainly due to the change in depth and the change in frequency in the treatment.

[0191] In one embodiment, different intervals can be generated by varying the frequency and focal depth as shown in Figure 29. For example, Equation 14 is:

[0192]

number

[0193] where s is the distance between two simultaneous foci at the same depth. This formula assumes that the separation between the foci is proportional to the focal depth (z f ) and is a function of frequency (since λ is the speed of sound divided by frequency). It is assumed that the same frequency and the same spatial frequency are used on the stripes. The table below summarizes the spacing for different focal points spaced 1.5 mm apart. [Table 6]

[0194] However, if the frequency is changed such that a larger frequency is used for the shallowest focus, a much wider range of separation distances can be obtained. [Table 7]

[0195] In various embodiments, the distance or spacing can be varied by using different w (e.g., w1, w2). In various embodiments, a continuous wave function can be used to simultaneously generate multiple focal zones at different depths below the skin surface while combining the frequency with a Fourier transform. In one embodiment, a focal zone (f1) at a first depth (d1) is simultaneously generated with a second focal zone (f2) at a second depth (d2) different from the first depth (d1). Both focal points at different depths (d1 and d2) can be simultaneously generated via a linear system that combines excitations to a single ultrasound transducer element. [Table 8] Now, two simultaneous focal points can be generated at variable distances using the following formula:

number

[0196] In various embodiments, the electrostrictive element exhibits piezoelectric behavior when a sufficient DC bias is applied to the material. In one embodiment, the strength of the piezoelectric behavior is proportional to the acoustic sensitivity. In one embodiment, the electrostrictive material is used with the treatment bowl in the manufacturing process. In one embodiment, the patterning and electrode attachment are performed at the time of manufacturing, but the polarization of the electrostrictive element is performed at the time of treatment delivery. For example, in one embodiment, the delivery aperture can be a square wave as shown in FIG. 37 or can be shaded through changing the high voltage value. FIG. 30 shows an 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 that can generate multiple pairs at different depths simultaneously. In one embodiment, the electrostrictive element can change spatial frequency (e.g., as shown in one embodiment in FIG. 37), thereby generating treatment lines (e.g., as shown in one embodiment in FIG. 34). In one embodiment, the electrostrictive element generates treatment lines without the use of a mechanical drive mechanism. In one embodiment, the electrostrictive element creates a line perpendicular to the movement of the mechanical drive mechanism. Thus, in various embodiments, treatment in multiple dimensions can create one, two, or more treatment focal zones at different intervals, in different lines, in different planes, or in different three-dimensional spaces. In some embodiments, the electrostrictive element creates a displacement of ions in the crystal lattice of the piezoelectric transducer when exposed to an external electric field. In various embodiments, Figures 17-29 have a fixed polarization pattern to create a separation distance between two simultaneously created TCPs. This is because the polarization pattern is created in 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 the poling is complete.In one embodiment, as shown in Figures 30-33, the electrostrictive material does not include polarization, but instead uses electrostrictive elements to apply a direct current (DC) voltage during operation of the device, thereby exhibiting piezoelectric behavior that can be used to improve device performance. Figure Sa shows the front and back (e.g., concave and convex) sides of a ceramic bowl similar to the embodiment shown in Figure 17. In one embodiment, the annular pattern is on the back (e.g., convex) side of the transducer. The front (patient side, e.g., concave) side appears slightly different compared to the embodiment of Figure 17, for example, the stripes are created with a finer pitch. Second, although the ceramic is not polarized, the connections from the individual stripes can be connected to individual banks of electronics to apply a voltage across the stripes, which can create the appropriate pattern that results in the separation between the TCPs. In one embodiment, the voltage is varied at a large spatial frequency, resulting in a larger separation between the TCPs. The electronics can vary this pattern so that the distance between the TCPs can also be changed. The result is a collection of simultaneous TCPs that can be generated through this amplitude modulation. There is no need to apply a negative or positive voltage on each stripe. In some embodiments, acoustic excitation is prevented or reduced by grounding the stripes. Figure 31 shows an embodiment of a type of TCPs distribution that can be generated in three dimensions. In one embodiment, five TCPs are generated at each depth, which is obtained by three different DC amplitude modulation patterns on the stripes. Again, the order can be changed within the 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 the TCPs as quickly as possible. Figure 32 shows a projection of the delivery along the mechanical movement (x-axis) and the depth (z-axis). Figure 33 shows a projection of the delivery along the direction in which the beam is split (y-axis) and along the depth direction (z-axis).The projection shows five TCPs generated in this plane. Two pairs of TCPs are generated simultaneously, one pair at a time, similar to a conventional transducer. In various embodiments, the techniques described with respect to the embodiments of Figures 21-29 are applicable with respect to the design of the electrostrictive elements.

[0197] 34-36 show an 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 a simultaneous treatment transducer allows for the simultaneous generation of two lines at different depths. In one embodiment, the advantage of using electrostrictive elements with sufficient stripes is the ability to generate heating lines for treatment when the pattern changes rapidly. FIG. 34 illustrates an embodiment showing three-dimensional TCPs lines generated using multiple spatial frequencies on the electrostrictive element pattern at only one depth. Depending on the rate of change of the pattern across the stripes, this heating can be altered to generate lines of micro-coagulation, or the hot lines are tissues of cell apoptosis. FIG. 35 shows a projection onto the xz plane to illustrate the five lines. FIG. 36 shows a projection onto the yz plane, showing heating lines along the y axis at a particular depth.

[0198] In one embodiment, FIG. 37 shows different patterns that can be produced when the stripes are fine pitched. In FIG. 37, the X-axis represents the distance across the transducer. The Y-axis represents the DC amplitude at the position across the transducer. Different DC signals applied across the transducer can result in different spacings between the focal points in various embodiments. In one embodiment, the fine pitch is related to the desired separation distance, operating frequency, and focal depth. 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 therein). This figure shows amplitude modulation that can result in different spacings of the micro-solidification points along the Y-axis. Although this figure covers factors of multiples of 2, it is possible to have other modulation patterns that fall between the multiples shown. The modulation patterns do not have to be integer 1× patterns. In various embodiments, even, odd, and null patterns are possible. Finally, electrostriction also offers the possibility to modulate the amplitude pattern since the 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 generation of simultaneous TCPs at multiple depths. In one embodiment, an advantage is the elimination of multiple transducers, thereby reducing transducer replacement by the operator. In one embodiment, an advantage is faster treatment time. In one embodiment, an advantage is the delivery of the same number of lines with fewer button presses. In one embodiment, an advantage is modulating the distance between simultaneously delivered TCPs. In one embodiment, an advantage is maintaining pitch separation between TCPs at each depth along the line of mechanical movement. In one embodiment, an advantage is avoiding pulse stacking at multiple depths. In one embodiment, an advantage is the ability to generate larger zones of coagulation and apoptosis. In one embodiment, an advantage is enabling the ability to deliver microcoagulation lines along three dimensions. In one embodiment, an advantage of using an electrostrictive element includes generating three or more lines by placing one transducer on the patient's body. In one embodiment, an advantage of using an electrostrictive element is modulating the distance between simultaneously delivered TCPs. In one embodiment, an advantage is the ability to modulate the spatial high frequency harmonics from the concurrent therapy modulation pattern. In one embodiment, an advantage of using electrostrictive elements is that it provides the possibility to add nulls to the modulation pattern. EXAMPLES

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

[0201] In some embodiments, an ultrasonic treatment system for generating multiple focal points at different depths with an ultrasonic transducer is provided, comprising: an ultrasonic probe with an ultrasonic transducer configured to apply ultrasonic therapy to tissue at a plurality of locations with at least two focal depths by at least one of the group consisting of amplitude modulated polarization and phase shifting; a drive mechanism configured to be programmable to provide spacing between a plurality of discrete cosmetic treatment zones, the sequence of the plurality of discrete cosmetic treatment zones having a treatment spacing in the range of 1 mm to 50 mm; and a control module coupled to the ultrasonic probe for controlling the ultrasonic transducer, the ultrasonic transducer configured to provide ultrasonic therapeutic acoustic power in the range of 10 W to 1000 W and a frequency of 1 MHz to 20 MHz to thermally heat tissue to cause coagulation. The plurality of locations can be arranged in a substantially linear sequence within the cosmetic treatment zone, and the ultrasonic transducer includes a single ultrasonic transducer element. In one embodiment, the first set of locations is disposed in a first cosmetic treatment zone and the second set of locations is disposed in a second cosmetic treatment zone, the first zone being distinct from the second zone. The first cosmetic treatment zone can include a substantially linear sequence of the first set of locations and the second cosmetic treatment zone can include a substantially linear sequence of the second set of locations.

[0202] The ultrasonic transducer, in one embodiment, is configured to apply ultrasonic therapy using amplitude modulation, where the multiple portions of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic therapy phase shift, where the multiple portions of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple phases of acoustic intensity, the first amplitude being different from the second phase. In one embodiment, the ultrasonic transducer is configured to apply ultrasonic therapy using amplitude modulation, where the multiple portions of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude, and further configured to apply ultrasonic therapy phase shift, where the multiple portions of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple phases of acoustic intensity, the first phase being different from the second phase. The multiple phases can include discrete phase values. The ultrasonic transducer can include a piezoelectric material, and the multiple portions of the ultrasonic transducer can be configured to generate corresponding multiple changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the changes in the piezoelectric material include at least one of an expansion of the piezoelectric material and a contraction of the piezoelectric material. The ultrasonic treatment system can have at least a portion of the ultrasonic transducer configured to emit ultrasonic treatments at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasonic treatment emitted by the at least a portion of the piezoelectric varies over time. In one embodiment, the drive mechanism is configured to be programmable to provide variable spacing between the plurality of discrete cosmetic treatment zones, and further includes one or more selectable tuning circuits. The ultrasonic treatment system can include a sequence of a plurality of discrete cosmetic treatment zones having treatment spacing in the range of 1 mm to 25 mm, and further includes a tuning circuit.In one embodiment, the ultrasound treatment is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, skin tightening, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, cellulite treatment, décolletage treatment, vaginal rejuvenation, and acne treatment. The ultrasound treatment system can include an ultrasound transducer configured to provide an ultrasound therapeutic acoustic power in the range of 10W to 100W and a frequency of 1MHz to 12MHz to thermally heat tissue to induce coagulation.

[0203] In some embodiments, a treatment system for generating multiple focal points at different depths simultaneously with an ultrasonic transducer is provided, the system including an ultrasonic probe including a first switch operably controlling an ultrasonic imaging function to provide ultrasonic imaging, a second switch operably controlling an ultrasonic treatment function to provide ultrasonic treatment, and a drive mechanism configured to direct the ultrasonic treatment to at least one sequence of a plurality of discrete thermal cosmetic treatment zones, a transducer module configured to apply ultrasonic treatment by at least one of the group consisting of amplitude modulated polarization and phase shift, the transducer module configured to perform both ultrasonic imaging and ultrasonic treatment, configured to be coupled to the ultrasonic probe, the transducer module including an ultrasonic transducer 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 including a processor and a display for controlling the transducer module. In one embodiment, the ultrasonic treatment is a cosmetic treatment, and the plurality of locations are arranged in a substantially linear sequence within the cosmetic treatment zone. The treatment system can include an ultrasound treatment that is a cosmetic treatment, where a first set of locations is disposed within a first treatment zone and a second set of locations is disposed within a second treatment zone, the first zone being different from the second zone. In one embodiment, the first treatment zone includes a substantially linear sequence of a first set of locations and the second treatment zone includes a substantially linear sequence of a second set of locations. The transducer module can be configured to apply the ultrasound treatment using amplitude modulation, where the portions of the transducer module are configured to emit the ultrasound treatment at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude.In one embodiment, the transducer module is configured to apply an ultrasound treatment phase shift, where the multiple portions of the transducer module are configured to emit ultrasound treatment at multiple phases of acoustic intensity, the first phase being different from the second phase. The transducer module can be configured to apply ultrasound treatment using amplitude modulation, where the multiple portions of the transducer module are configured to emit ultrasound treatment at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude, and further configured to apply an ultrasound treatment phase shift, where the multiple portions of the transducer module are configured to emit ultrasound treatment at multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the multiple phases include discrete phase values. The transducer module can include a piezoelectric material, where the multiple portions of the transducer module are configured to generate corresponding multiple changes in the piezoelectric material in response to an electric field applied to the transducer module. In one embodiment, the multiple changes in the piezoelectric material include at least one of an expansion of the material and a contraction of the material. The treatment system may include at least some of the transducer modules configured to emit ultrasonic treatments at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasonic treatment emitted by at least some of the transducer modules varies over time. In one embodiment, the drive mechanism is configured to be programmable to provide variable spacing between the plurality of discrete thermal cosmetic treatment zones. The treatment system may include a sequence of a plurality of discrete thermal cosmetic treatment zones having treatment spacing in the range of 1 mm to 25 mm. In one embodiment, the first switch and the second switch include a button or key operated by a user. The treatment system may include at least one first switch and a second switch activated by the control module.In one embodiment, the treatment function is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, cellulite treatment, décolletage treatment, vaginal rejuvenation, and acne treatment. The transducer module can be configured to provide ultrasonic therapeutic acoustic power in the range of 10W to 1000W and frequencies of 1MHz to 20MHz to thermally heat tissue to induce coagulation.

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

[0205] In some embodiments, a method of performing a non-invasive cosmetic procedure on skin by generating multiple simultaneous focal points at multiple depths with a single transducer includes coupling a transducer module to an ultrasound probe including 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 spacing between the multiple individual cosmetic treatment zones; contacting the transducer module against a skin surface of a subject; acoustically imaging an area below the skin surface with the transducer module by activating a first switch on the ultrasound probe; and acoustically treating an area below the skin surface with a desired sequence of multiple individual cosmetic treatment zones controlled by the drive mechanism by activating a second switch on the ultrasound probe, wherein the transducer module includes a single ultrasound transducer configured to apply ultrasound treatment to tissue at multiple focal depths.

[0206] In some embodiments, an ultrasound treatment system for generating multiple focal points simultaneously at multiple depths in tissue with an ultrasound transducer includes a control device operatively controlling an ultrasound treatment function to provide ultrasound treatment, and a hand wand configured to direct the ultrasound treatment to a sequence of multiple discrete thermal cosmetic treatment zones, the hand wand including a transducer configured to apply ultrasound treatment to tissue at multiple locations at the focal depths. One embodiment is a non-invasive cosmetic treatment of the skin.

[0207] In some embodiments, an imaging and treatment system for use in cosmetic treatment at multiple depths within tissue includes an ultrasonic probe configured to perform ultrasonic imaging and ultrasonic treatment of tissue at multiple focal depths, the ultrasonic probe including a transducer module configured to be coupled to the ultrasonic probe, the transducer module including an ultrasonic transducer configured to apply ultrasonic treatment to tissue at multiple locations at the focal depth, a first switch operably controlling an ultrasonic imaging function to provide ultrasonic imaging, a second switch operably controlling an ultrasonic treatment function to provide ultrasonic treatment, a drive mechanism configured to direct the ultrasonic treatment to at least one sequence of multiple discrete 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 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 zone. The imaging and treatment system may include a first set of locations disposed in a first cosmetic treatment zone and a second set of locations disposed in a second cosmetic treatment zone, the first zone being different from the second zone. In one embodiment, the first cosmetic treatment zone includes a substantially linear sequence of the first set of locations, and the second cosmetic treatment zone includes a substantially linear sequence of the second set of locations. The transducer module may be configured to apply ultrasound treatment using amplitude modulation, where the multiple portions of the transducer module are configured to emit ultrasound treatment at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. In one embodiment, the transducer module is configured to apply an ultrasound treatment phase shift, where the multiple portions of the transducer module are configured to emit ultrasound treatment at multiple phases of acoustic intensity, the first phase being different from the second phase.The transducer module can be configured to apply ultrasonic treatment using amplitude modulation, where the multiple parts of the transducer module are configured to emit ultrasonic treatment at multiple amplitudes of acoustic intensity, where a first amplitude is different from a second amplitude, and can be further configured to apply ultrasonic treatment phase shift, where the multiple parts of the transducer module are configured to emit ultrasonic treatment at multiple phases of acoustic intensity, where a first phase is different from a second phase. In one embodiment, the multiple phases include discrete phase values. The transducer module can include a piezoelectric material, where the multiple parts of the transducer module are configured to generate corresponding multiple changes in the piezoelectric material in response to an electric field applied to the transducer module. In one embodiment, the multiple changes in the piezoelectric material include at least one of material expansion and material contraction. At least some of the transducer modules can be configured to emit ultrasonic treatment at two or more amplitudes of acoustic intensity, where the amplitude of the ultrasonic treatment emitted by at least some of the transducer modules varies over time. In one embodiment, the drive mechanism is configured to be programmable to provide variable spacing between the multiple discrete thermal cosmetic treatment zones. The sequence of discrete thermal cosmetic treatment zones can have a treatment interval in the range of 0.01 mm to 25 mm. In one embodiment, the first switch and the second switch include a user operated button or key. At least one of the first switch and the second switch can be activated by the control module. In one embodiment, the treatment function is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, vaginal rejuvenation, and acne treatment. The transducer module can be configured to provide an ultrasonic therapeutic acoustic power in the range of 10 W to 1000 W and a frequency of 1 MHz to 10 MHz to thermally heat tissue to induce coagulation.

[0208] In some embodiments, a multi-focused ultrasound treatment system for simultaneous treatment at multiple depths includes a control device operatively controlling an ultrasound treatment function to provide ultrasound treatment, and a hand wand configured to guide the ultrasound treatment to a sequence of multiple discrete thermal cosmetic treatment zones, the hand wand including a transducer configured to apply ultrasound therapy to tissue at locations at the focal depths, the locations being positioned within the thermal cosmetic treatment zones, the transducer further configured to apply ultrasound therapy to tissue simultaneously at multiple locations at the focal depths.

[0209] In some embodiments, a system for imaging at multiple depths and simultaneous multi-focal treatment includes a module including an ultrasound transducer configured to apply ultrasound therapy to tissue at multiple focal depths by at least one of the group consisting of amplitude modulated polarization and phase shifting, the module further including an interface guide designed to removably couple to a hand wand to provide electronic communication and power between the module and the hand wand. In one embodiment, the locations are arranged in a substantially linear sequence within a cosmetic treatment zone. A first set of the locations can be located within a first cosmetic treatment zone and a second set of the locations can be located within a second cosmetic treatment zone, the first zone being different from the second zone. In one embodiment, the first cosmetic treatment zone includes a first set of the locations in a substantially linear sequence and the second cosmetic treatment zone includes a second set of the locations in a substantially linear sequence. The ultrasonic transducer can be configured to apply ultrasonic therapy using amplitude modulation, where multiple portions of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. In one embodiment, the ultrasonic transducer is configured to apply an ultrasonic therapy phase shift, where multiple portions of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple phases of acoustic intensity, the first amplitude being different from the second phase. The ultrasonic transducer can be configured to apply ultrasonic therapy using amplitude modulation, where multiple portions of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude, and further configured to apply an ultrasonic therapy phase shift, where multiple portions of the ultrasonic transducer are configured to emit ultrasonic therapy at multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the multiple phases include discrete phase values.The ultrasonic transducer may include a piezoelectric material, and the portions of the ultrasonic transducer may be configured to generate corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the changes in the piezoelectric material include at least one of an expansion of the piezoelectric material and a contraction of the piezoelectric material. At least a portion of the ultrasonic transducer may be configured to emit ultrasonic treatments 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 varies over time. In one embodiment, the imaging and treatment system further includes a drive mechanism configured to be programmable to provide spacing between the multiple discrete cosmetic treatment zones. The sequence of multiple discrete cosmetic treatment zones may have a treatment spacing in the range of 1 mm to 50 mm. In one embodiment, the ultrasound treatment is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, vaginal rejuvenation, and acne treatment. The ultrasound transducer can be configured to provide an ultrasound therapeutic acoustic power in the range of 1 W to 100 W and a frequency of 1 MHz to 10 MHz to thermally heat tissue to induce coagulation.

[0210] In some embodiments, a treatment system for simultaneous treatment at multiple depths includes a control device operatively controlling an ultrasonic treatment function to provide ultrasonic treatment, and a hand wand configured to guide the ultrasonic therapy to a sequence of multiple discrete thermal cosmetic treatment zones, the hand wand including an ultrasonic transducer configured to simultaneously apply ultrasonic therapy to tissue at multiple locations at a focal depth.

[0211] In some embodiments, a non-physician-performed non-invasive method of performing cosmetic procedures simultaneously at multiple depths includes coupling a transducer module to an ultrasound probe, where the transducer module includes an ultrasound transducer configured to apply ultrasound treatment to tissue at multiple locations at a focal depth with at least one of the group consisting of amplitude modulated polarization and phase shifting, and the ultrasound probe includes a first switch for controlling acoustic imaging, a second switch for controlling acoustic treatment to induce multiple discrete cosmetic treatment zones, and a drive mechanism for providing desired spacing between the multiple discrete cosmetic treatment zones; contacting the transducer module against a skin surface of a subject; acoustically imaging an area below the skin surface with the transducer module by activating the first switch on the ultrasound probe; and acoustically treating the area below the skin surface with a desired sequence of multiple discrete cosmetic treatment zones controlled by the drive mechanism by activating the second switch of the ultrasound probe.

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

[0213] In some embodiments, an ultrasonic treatment system for dithering multiple simultaneous focal points at multiple depths from an ultrasonic transducer includes an ultrasonic probe including an ultrasonic transducer having a single transducer element adapted to simultaneously apply ultrasonic therapy to tissue at multiple spaced focal depths, the ultrasonic transducer being polarized with 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, the control module changing the distance between the spaced apart positions via dithering the first and second focal zones, thereby precisely moving the position of the beam focal point at the spaced apart positions via dithering via frequency modulation. The multiple positions can be arranged in a linear sequence within the cosmetic treatment zone, and the spaced apart positions are spaced apart by spatial dithering via frequency swing. In one embodiment, a first set of the multiple positions is arranged within a first cosmetic treatment zone, and a second set of the multiple positions is arranged within a second cosmetic treatment zone, the first zone being different from the second zone. The ultrasonic transducer may be adapted to apply ultrasonic therapy using amplitude modulation, where the multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, the first amplitude being different 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, where the amplitude of ultrasonic therapy emitted by at least a portion of the piezoelectric body varies over time. The ultrasonic transducer may include a piezoelectric material, where the multiple portions of the ultrasonic transducer are adapted to generate corresponding multiple 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 an expansion of the piezoelectric material and a contraction of the piezoelectric material. The ultrasonic transducer may be adapted to apply ultrasonic therapy via phase shift, where the multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, the first phase being different from the second phase.In one embodiment, the multiple phases include discrete phase values. The ultrasonic transducer can be adapted to apply ultrasonic treatment using amplitude modulation, where multiple portions of the ultrasonic transducer are adapted to emit ultrasonic treatment at multiple amplitudes of acoustic intensity, where a first amplitude is different from a second amplitude, and can be adapted to apply ultrasonic treatment, where multiple portions of the ultrasonic transducer are adapted to emit ultrasonic treatment at multiple phases of acoustic intensity, where a first phase is different from a second phase. In one embodiment, the ultrasonic treatment is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, décolletage improvement, buttocks lift, scar reduction, burn treatment, skin tightening, blood vessel reduction, sweat gland treatment, sun spot removal, fat treatment, abdominal laxity treatment, and cellulite treatment. The ultrasonic probe can include a drive mechanism adapted to guide the ultrasonic treatment to at least one pair of simultaneous sequences 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 can include a transducer module adapted to apply ultrasound therapy.

[0214] In some embodiments, an ultrasonic treatment system for use in cosmetic treatment for dithering multiple simultaneous focal points at multiple depths from an ultrasonic transducer includes an ultrasonic probe including a control module adapted to vary a spacing between a first focal zone and a second focal zone via dithering, a switch operably controlling an ultrasonic treatment function to provide ultrasonic treatment, and a drive mechanism adapted to guide the ultrasonic treatment to at least one pair of simultaneous sequences of multiple discrete thermal cosmetic treatment zones, a transducer module adapted to apply ultrasonic treatment, the transducer module adapted to perform both ultrasonic imaging and ultrasonic therapy, adapted to be coupleable to the ultrasonic probe, and including an ultrasonic transducer adapted to apply ultrasonic treatment to tissue at multiple locations having at least two focal depths, the transducer module adapted to be operably coupled to at least one of the switch and the drive mechanism, and a control module including a processor and a display for controlling the transducer module. In one embodiment, the transducer module is adapted to apply the ultrasound treatment using amplitude modulation, where the multiple portions of the transducer module are adapted to emit the ultrasound treatment at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. The transducer module can be adapted to apply the ultrasound treatment, where the multiple portions of the transducer module are adapted to emit the ultrasound treatment at multiple phases of acoustic intensity, the first phase being different from the second phase.

[0215] In some embodiments, an ultrasonic treatment system for dithering simultaneous multi-focal treatment at multiple depths includes a module including an ultrasonic transducer adapted to simultaneously apply ultrasonic therapy to tissue at multiple spaced depths within the tissue, the module altering the spacing between the multiple spaced depths via dithering a first focal zone and a second focal zone, thereby allowing precise movement of the beam focal point at the multiple spaced depths by dithering with frequency modulation, and the module further includes an interface guide designed to removably couple to a hand wand to provide electronic communication and power between the module and the hand wand. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy using amplitude modulation, where multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. The ultrasonic transducer can be adapted to apply ultrasonic therapy, where multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and the portions of the ultrasonic transducer are adapted to generate 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 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 face lift, brow lift, chin lift, eye treatment, wrinkle reduction, décolletage improvement, buttocks lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, cellulite treatment, abdominal laxity treatment, vaginal rejuvenation, and acne treatment.

[0216] In some embodiments, a method of dithering multiple simultaneously focused ultrasound treatment beams at multiple depths includes providing an ultrasound probe including an ultrasound transducer having a single transducer element adapted to simultaneously apply ultrasound therapy to tissue at multiple spaced apart locations at multiple focal depths, and a control module coupled to the ultrasound probe for controlling the ultrasound transducer, and moving a location of an ultrasound focal point at the multiple spaced apart locations by dithering a spacing between the multiple spaced apart locations 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 imaging element. The method can further include imaging the second focal zone with an ultrasound imaging element. In one embodiment, the spacing between the first and second focal zones is dithered in a range of 1% to 50%. The spacing between the first and second focal zones can be 1.5 mm with 0.1 mm increments. In one embodiment, the frequency modulation is in a range of 1% to 50%. The ultrasound treatment may be at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, décolletage improvement, buttocks lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, vaginal rejuvenation, abdominal relaxation treatment, and acne treatment.

[0217] In some embodiments, a method of simultaneously dithering a single focused ultrasound beam at multiple depths includes providing an ultrasound probe including a single transducer element and a control module, where the single transducer element is adapted to apply ultrasound therapy to tissue at a focal zone at the focal depth and the control module is coupled to the ultrasound probe for controlling the single transducer element, and varying a size of the focal zone at the tissue by dithering the focal zone via frequency modulation. In one embodiment, the relative positions of the focal zones are dithered in a range of 1% to 50%. A second focal zone may be emitted simultaneously from the single transducer element. In one embodiment, the frequency modulation is in a range of 1% to 50%. The system can be designed to operate non-invasively in treating tissue. In one embodiment, the method functions in a non-invasive manner in treating tissue.

[0218] In some embodiments, an ultrasonic treatment system for delivering simultaneous multi-focal treatment at multiple depths by electrostrictive elements includes a module including an ultrasonic transducer, the ultrasonic transducer adapted to simultaneously apply ultrasonic therapy to tissue at multiple spaced depths within the tissue by application of the electrostrictive element, the module altering the spacing between the multiple spaced depths within the tissue via dithering of a first focal zone and a second focal zone, thereby allowing precise movement of the beam focal position at the multiple spaced depths via dithering via frequency modulation, the module further including an interface guide designed to removably couple to a hand wand to provide electronic communication and power between the module and the hand wand. In one embodiment, the ultrasonic transducer is adapted to apply ultrasonic therapy using amplitude modulation, where multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. The ultrasonic transducer can be adapted to apply ultrasonic therapy, where multiple portions of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple phases of acoustic intensity, a first phase being different from a second phase. In one embodiment, the ultrasonic transducer includes a piezoelectric material, and multiple portions of the ultrasonic transducer are adapted to generate 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 at 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 face lift, brow lift, chin lift, eye treatment, wrinkle reduction, décolletage improvement, buttocks lift, scar reduction, burn treatment, tattoo removal, skin tightening, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, cellulite treatment, abdominal laxity treatment, vaginal rejuvenation, and acne treatment.

[0219] Some embodiments are ultrasound treatment systems having one or more features set forth in the above description.

[0220] Some embodiments are methods of reducing imaging misregistration in a moving ultrasound transducer having one or more features described in the above description.

[0221] Some embodiments are an ultrasound treatment system for generating multiple simultaneous focal points from a single ultrasound transducer having one or more features described in the above description.

[0222] Some embodiments are ultrasound treatment systems for delivering multi-focal treatment having one or more features described in the above description.

[0223] Some embodiments are an ultrasonic treatment module for use in cosmetic treatments for creating multiple simultaneous focal zones from a single ultrasonic transducer having one or more features described in the above description.

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

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

[0226] The several embodiments and examples described herein are exemplary and are not intended to be limiting in describing the full scope of the compositions and methods of these inventions. Equivalent changes, modifications and variations of the several embodiments, materials, compositions and methods may be made within the scope of the present invention with substantially similar results.

[0227] While the present invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and described in detail herein. However, it will be understood that the present invention is not limited to the specific forms or specific methods disclosed, but rather, the present invention encompasses all modifications, equivalents, and alternatives falling within the spirit and scope of the various described embodiments and the appended claims. Any method disclosed herein need not be performed in the order described. The methods disclosed herein include specific actions taken by a practitioner, but may also include any third-party instructions regarding those actions, either explicitly or implicitly. For example, an action such as "coupling a transducer module with an ultrasound probe" includes "instructing to couple a transducer module with an ultrasound probe." Ranges disclosed herein also encompass any and all overlaps, subranges, and combinations thereof. Terms such as "up to," "at least," "greater than," "less than," and "between" include the stated numerical value. Numeric values ​​following terms such as "about" or "approximately" include the stated numerical value. For example, "about 25 mm" includes "25 mm." [Explanation of symbols]

[0228] 10 Areas of Interest 20 Ultrasound Systems 50 Released Energy 100 Hand Wand 130 Interface 150 Imaging controller, switch 160 Heat treatment controller, switch 200 Module 270 Offset Distance 278 Depth of focus 279 Tissue Depth 280 Ultrasonic Transducer 281 Treatment channel, treatment channel annular transducer element 282 Convex 283 Concave 285 Imaging Converter 300 Controller 310 Interactive Graphic Display 320 Access Key 400 Drive Mechanism 500 Target 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 coagulation zone, thermal coagulation point, TCP

Claims

1. An ultrasonic treatment system for dithering the focus from an ultrasonic transducer at one or more depths, An ultrasonic probe comprising an ultrasonic transducer having a single converter element adapted to simultaneously apply ultrasound to tissue, wherein the ultrasonic transducer is polarized in at least a first polarization configuration and a second polarization configuration, A control module coupled to the ultrasonic probe for controlling the ultrasonic transducer, Equipped with, The control module modifies the distance between the first and second focal zones via dithering, and the dithering includes frequency modulation as a frequency swing around the aperture center frequency during operation, such that the distance between the first and second focal zones changes over time while the ultrasound is simultaneously applied to the tissue. An ultrasonic treatment system wherein the dithering includes electronically scattering the focal position of the beam in the first focal zone and electronically scattering the focal position of the beam in the second focal zone over time, and the dithering expands the treatment area associated with the first focal zone and the second focal zone, respectively.

2. The ultrasonic treatment system according to claim 1, wherein the first focal zone and the second focal zone are located in a linear sequence within the cosmetic treatment zone, and the first focal zone and the second focal zone are separated by an interval that is dithered via frequency swing.

3. The ultrasonic treatment system according to claim 1, wherein a first set of positions is located within a first cosmetic treatment zone, a second set of positions is located within a second cosmetic treatment zone, and the first focal zone is different from the second focal zone.

4. The ultrasonic treatment system according to claim 1, wherein the ultrasonic transducer is adapted to apply ultrasound using amplitude modulation, so that a plurality of parts of the ultrasonic transducer are adapted to emit ultrasound at a plurality of amplitudes of acoustic intensity, where the first amplitude is different from the second amplitude.

5. The ultrasonic treatment system according to claim 4, wherein at least one portion of the ultrasonic transducer is adapted to emit ultrasonic waves at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasonic waves emitted by the at least one portion of the piezoelectric body changes over time.

6. The ultrasonic treatment system according to claim 4, 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.

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

8. The ultrasonic treatment system according to any one of claims 1 to 4, 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, the first phase being different from the second phase.

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

10. The ultrasonic transducer, The method involves applying ultrasound using amplitude modulation, thereby adapting multiple parts of the ultrasound transducer to emit ultrasound at multiple amplitudes of acoustic intensity, wherein the first amplitude is different from the second amplitude. The method involves applying ultrasound, thereby adapting multiple parts of the ultrasound transducer to emit ultrasound at multiple phases of acoustic intensity, wherein the first phase is different from the second phase. An ultrasonic treatment system according to any one of claims 1 to 4, adapted to perform the following:

11. The ultrasound treatment system according to any one of claims 1 to 4, 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.

12. The ultrasonic treatment system according to any one of claims 1 to 4, wherein the ultrasonic probe comprises a drive mechanism adapted to direct ultrasonic treatment in at least one simultaneous sequence of individual thermal cosmetic treatment zones.

13. The ultrasound treatment system according to any one of claims 1 to 4, wherein the ultrasound probe is configured for both ultrasound imaging and ultrasound treatment.

14. The ultrasonic treatment system according to any one of claims 1 to 4, wherein the ultrasonic rope comprises a transducer module adapted for applying ultrasonic waves.

15. An ultrasonic treatment system for dithering multiple simultaneous focal points from an ultrasonic transducer at multiple depths, An ultrasound probe comprising an ultrasound transducer having a single transducer element adapted to simultaneously apply ultrasound therapy to tissue at a plurality of spaced-out focal depths, generating two or more simultaneous focal zones below the skin surface, wherein the ultrasound transducer includes a convex side and a concave side, and at least one of the convex side and the concave side has a stripe, the stripe including a first polarization region and a second polarization region such that the ultrasound transducer is polarized in at least a first polarization configuration and a second polarization configuration, A control module coupled to the ultrasonic probe for controlling the ultrasonic transducer, Equipped with, The control module is configured to generate two or more simultaneous focal points at one or more depths by independently applying different phases or different amplitudes to generate two or more simultaneous focal points in parallel. The control module is further configured to electronically dither the depth of focus of at least one of the two or more focus zones by temporally modulating the phase applied to one or more of the stripes so that the position of each focus zone changes over time. The control module is configured to generate simultaneous focal zones at laterally separated positions in each of the one or more depths by controlling the signal applied to the stripe, and is configured to expand the focal zones and change the lateral spacing between the separated positions through dithering of the first and second focal zones, thereby allowing the dithering via frequency modulation to precisely move the beam focal position at the separated positions while maintaining the respective focal depths. An ultrasonic treatment system wherein the dithering includes electronically scattering the position of the focal zone by changing the frequency of the ultrasonic treatment beam, and therefore the focal zone, and the dithering is accompanied by a change in the position of the focal zone, such that the relative position of the focal zone is dithered by 1 to 50%.

16. The ultrasonic treatment system according to claim 15, wherein the separated positions are located in a linear sequence within the cosmetic treatment zone, and the separated positions are separated by an interval that is dithered via frequency swing.

17. The ultrasonic treatment system according to claim 15, wherein a first set of positions is located within a first cosmetic treatment zone, a second set of positions is located within a second cosmetic treatment zone, and the first cosmetic treatment zone is different from the second cosmetic treatment zone.

18. The ultrasonic treatment system according to claim 15, wherein the ultrasonic transducer is adapted to apply ultrasonic treatment using amplitude modulation, so that 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.

19. The ultrasonic treatment system according to claim 18, 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.

20. The treatment system according to claim 19, wherein at least one portion of the ultrasonic transducer is adapted to emit ultrasonic therapy at two or more amplitudes of acoustic intensity, and the amplitude of ultrasonic therapy emitted by the at least one portion of the piezoelectric material changes over time.

21. The ultrasonic treatment system according to any one of claims 15 to 18, wherein the ultrasonic transducer is adapted to apply ultrasonic treatment via a phase shift, so that multiple parts of the ultrasonic transducer are adapted to emit ultrasonic treatment at multiple phases of acoustic intensity, the first phase being different from the second phase.

22. The ultrasonic treatment system according to claim 21, wherein the plurality of phases include discrete phase values.

23. The ultrasonic transducer, The method involves applying ultrasonic therapy using amplitude modulation, wherein multiple parts of the ultrasonic transducer are adapted to emit ultrasonic therapy at multiple amplitudes of acoustic intensity, and the first amplitude is different from the second amplitude. The method involves applying ultrasonic therapy, thereby adapting multiple parts of the ultrasonic transducer to emit ultrasonic therapy at multiple phases of acoustic intensity, wherein the first phase is different from the second phase. An ultrasonic treatment system according to any one of claims 15 to 18, adapted to perform the following:

24. The ultrasonic treatment according to any one of claims 15 to 18, wherein the ultrasonic probe comprises a drive mechanism adapted to direct ultrasonic treatment in at least one simultaneous sequence of individual thermal cosmetic treatment zones.

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