RU2785827C2 - Systems and methods for cosmetic ultrasonic treatment of skin - Google Patents

Abstract

FIELD: group of inventions relates to medical equipment.

SUBSTANCE: embodiments of a system for dermatological cosmetic treatment and/or imaging are proposed with the possibility of performing wobble of ultrasonic beams from a transducer to change the location and position of cosmetic treatment zones in the tissue, simultaneous multifocal therapy using mixing of a multichannel signal and/or wobble of ultrasonic beams from a transducer to change the placement and positions of cosmetic treatment zones in the tissue, as well as with the possibility of using visualization to improve the effectiveness of ultrasound therapy and/or with the possibility of performing imaging with the definition of the sequence for focal areas and actuation for mechanically translated and/or controlled ultrasound transducers. The system may include a hand probe, a removable transducer module, and a control module.

EFFECT: improvement the effectiveness of ultrasound therapy.

17 cl, 33 dwg, 4 tbl

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority over U.S. Provisional Application No. 62/375,607 filed August 16, 2016, U.S. Provisional Application No. 62/482,476 filed April 6, 2017, U.S. Provisional Application No. 62/482,440 filed April 6, 2017, and U.S. Provisional Application No. 62/520,055, filed June 15, 2017, each of which is hereby incorporated by reference in its entirety. All possible priority claims listed in the Application Information Sheet, or any corrections thereto, are incorporated herein by reference (37 CFR 1.57).

State of the art

Technical field

[0002] Some embodiments of the present invention relate to a non-invasive energy-based treatment to provide an aesthetic and/or cosmetic enhancement effect to the skin and/or tissues adjacent to the skin of the face, head, neck, and/or body of a human.

Description of the prior art

[0003] Some cosmetic procedures include invasive procedures, which may involve the use of invasive surgery. In addition to having to endure weeks of recovery, patients are also often subjected to risky anesthesia procedures. Non-invasive therapeutic energy-based devices and methods are available, but they may have various drawbacks regarding efficiency and effectiveness. Some cosmetic procedures create a sequential series of treatment points or lines. In these procedures, a processing period is a collection of successive processing procedures.

Disclosure of the essence of the invention

[0004] In some embodiments, systems and methods are provided that provide an aesthetic effect using directed and precise ultrasound to obtain a visible and effective cosmetic result using a thermal method by splitting the ultrasound therapy beam into two, three, four or more simultaneously existing focal zones. to perform various processing and/or visualization procedures. In various embodiments, the ultrasound system is configured to focus ultrasound to create localized mechanical motion in tissues and cells to achieve localized heating to either coagulate the tissue or mechanically disrupt the cell membrane for non-invasive aesthetic use. In various embodiments, the ultrasound system is configured to lift the brow ridge (eg, eyebrow). In various embodiments, the ultrasound system is capable of being lifted to lift loose tissue, such as submental (located under the chin) and neck tissue. In various embodiments, the implementation of the ultrasound system is configured to improve lines and wrinkles in the décolleté. In various embodiments, the implementation of the ultrasound system is configured to reduce the amount of fat. In various embodiments, the implementation of the ultrasound system is configured to reduce the likelihood of cellulite.

In various embodiments, the ultrasound system is imaging capable of imaging tissue (eg, dermal and subdermal layers of tissue) to ensure proper transducer-skin interaction. In various embodiments, the ultrasound system is imaging capable of imaging tissue (eg, dermal and subdermal layers of tissue) to confirm an appropriate treatment depth, eg, to prevent treatment of certain tissues (eg, bone).

[0005] In various embodiments, treating tissue, such as skin tissue, with multiple beams provides one or more benefits such as, for example, reduced processing time, creation of unique heating patterns, efficient use of multiple channels to achieve greater power, the ability to process skin at two or more depths at the same or different power levels (e.g. thermal coagulation point in the superficial musculoaponeurotic system ("SMAS") and other defocused energy at the skin surface or other combinations), in some cases simultaneous treatment at different depths ( for example, at depths below the skin surface at 3 mm and 4.5 mm at thermal coagulation points simultaneously or in overlapping time periods); and/or treatment with simultaneous application of one, two or more linear or linear foci, for example, at different depths below the skin surface or at a distance from each other. In some embodiments, wobble is used in concurrent multifocal therapy.

[0006] In some embodiments, systems and methods are provided that improve the effectiveness and/or effectiveness of an aesthetic effect using directed and precise ultrasound to achieve a visible and effective cosmetic result using a thermal method. In some embodiments, one focal zone is defined. In some embodiments, the ultrasound therapy beam is split into two, three, four or more concurrent focal zones to perform various processing and/or imaging procedures. In particular, embodiments of the present invention increase efficiency and/or efficiency in ensuring proper interaction between the treatment device and the tissue for performing treatment in the treatment area.

[0007] In some embodiments, systems and methods are provided that provide increased efficiency and/or effectiveness of an aesthetic effect using directed and precise ultrasound to obtain a visible and effective cosmetic result using a thermal method by splitting the ultrasound therapy beam into two, three, four or more simultaneously existing focal zones for performing various processing and/or imaging procedures.

[0008] In one embodiment, two or more therapeutic treatment points and/or focal areas are created simultaneously under the surface of the skin to perform a cosmetic treatment using an ultrasonic treatment system, wherein the treatment points are enlarged by wobbled ultrasonic beams. 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. Wobbling the ultrasonic beam focus points increases the treatment area by wobbling, blurring, or distorting the focus point or focus area (e.g., a point, line, plane, or volumetric focus area) similar to passing paint through a mechanical and/or electronic dispersion spray gun by changing the location of the focus points frequencies, and thus focus points, of ultrasonic beams. In some embodiments, wobble improves efficiency by creating larger processing points and/or focal zones. In some embodiments, the implementation of the wobble reduces pain, because the temperature of the hot spot is distributed over a larger volume of tissue, potentially allowing to reduce the dose. In some embodiments, mechanical wobble is one way of propagating acoustic energy from the ultrasound beam, so there is less dependence on tissue thermal conductivity at some distance from the focus. In one embodiment of mechanical wobble, the therapy transducer is locally moved around the intended center of the thermal coagulation point (TCP). The acoustic beam can be moved transversely, up and down and/or at an angle. In one embodiment of the mechanical wobble, movement of the movement mechanism is fast enough to create a flatter temperature profile around the intended TCP, allowing either reduction of the total acoustic energy for the same volume of tissue being treated, or applying the same amount of total acoustic energy. energy for a larger volume of tissue being treated, or any combination thereof.

[0009] In accordance with various embodiments, the frequency modulation results in a change in the location of the focal zone and/or the spacing between the focal zones in such a way that the electronic wobble of the beam by frequency modulation results in a precise change and/or movement of the position of the beam focus point(s). For example, in one embodiment, a 1.5 mm spacing can be wobbled at +/- 0.1 mm using a small frequency range. In various embodiments, any one or more intervals of 0.5, 0.75, 1.0, 1.2, 1.5, 2.0 mm can be wobbled with a value of +/- 0.01, 0.05, 0 .1, 0.12, 0.15, 0.20, 0.25, 0.30 mm using some frequency range. In various embodiments, the frequency is modulated by 1-200% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 100%, 120%, 150%, 180%, 200% and any range in between).

[0010] Some embodiments relate to devices, systems, and methods for rapidly, safely, efficiently, and effectively providing one or more (e.g., multiple) focus areas and/or sonication points in various sonication and/or imaging procedures. In some embodiments, imaging is not used. Some embodiments relate to splitting the ultrasound therapy beam into two, three, four or more focal zones from one ultrasound transducer and/or one ultrasound transducer element. In some embodiments, a plurality of ultrasonic beams are controlled electronically using frequency modulation. In some embodiments, wobble (eg, electronic wobble) of multiple and/or split apertures of the ultrasound beam using frequency modulation provides treatment zones or points at multiple locations. In some embodiments, wobble refers to the intentional movement of the position/location of the focal point of the energy beam. For example, in one embodiment, the wobble includes rocking, moving, vibrating, changing the location and/or position of one focal area, and/or spacing between two or more focal areas. In various embodiments, the relative position of the focal zones is wobbled at 1-50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, and any intermediate range, such as a percentage of the average location by a certain percentage). In various embodiments, the distance between the focal zones is wobbled in the range of 1-50% (for example, 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50% and any intermediate range). In some embodiments, wobble may be provided by mechanical, electronic, or combinations of mechanical and electronic means, depending on the design of the system. In one embodiment of the mechanical wobble, the ultrasound beam is moved locally around the intended center of the TCP by mechanically translating or tilting the transducer for therapy or the patient, or any combination of these methods. Mechanical translation and/or tilting allows the distribution of acoustic energy in such a way as to overcome the limitations of the thermal conductivity of the tissue. This allows for a flatter tissue temperature profile to either reduce the total acoustic energy to produce the same volume of tissue exposure, or provide the same total acoustic energy with an increase in the volume of tissue being treated compared to a stationary ultrasound device. therapy. Various embodiments of electronic wobble use frequency, phase, amplitude modulation, or time-based methods in combination with a uniquely defined transducer to move the ultrasound beam into tissue without any mechanical movement. In one embodiment, the electronic movement of the ultrasound beam is significantly faster than the mechanical movement, overcoming the limitation of tissue thermal conductivity. In various embodiments, the ratio of relative positioning of the focal zone by wobble is 1:1000, 1:500, 1:200; 1:100, 1:50, 1:25, 1:10, 1:2 or equal to any ratio between 1:1000 and 1:1. In various embodiments, the ratio of the mutual positioning interval between the focal zones by wobble is 1:1000, 1:500, 1:200; 1:100, 1:50, 1:25, 1:10, 1:2 or equal to any ratio between 1:1000 and 1:1. For example, in some embodiments, the focal zone is provided at "1" and the raw tissue open interval ratio is provided at the second ratio number. For example, in one embodiment, the wobble interval is, for example, 1 mm and the wobble distance is 0.1 mm, so the ratio is 1:10. In various embodiments, the ratio of the interval between focal zones by wobble is 1:1000, 1:500, 1:200; 1:100, 1:50, 1:25, 1:10, 1:2 or equal to any ratio between 1:1000 and 1:1. In some embodiments, an interval of simultaneously existing focal zones is wobbled. In some embodiments, the treatment points and/or zones are formed in the tissue at the same time. In various embodiments, the implementation of the wobble to perform various processing and/or imaging procedures is modulated and/or multi-phase with adjustable frequency deviation. Some embodiments relate to splitting the ultrasound therapy beam into two, three, four or more focal zones to perform different processing, such as using wobble, polarization, phasing and/or modulation techniques and/or imaging procedures.

[0011] In some embodiments disclosed herein, non-invasive ultrasound systems are configured to be used to achieve one or more of the following aesthetic and/or cosmetic enhancement benefits: facial skin tightening, brow lift, chin lift, eye contour treatments (e.g. , paint bags, treatment of infraorbital laxity), wrinkle reduction, fat reduction (eg, treatment of adipose tissue and/or cellulite), treatment of cellulite (also called gynoid lipodystrophy) (eg, female gynoid lipodystrophy with pitted or not), cleavage skin enhancements (eg, upper chest), buttock lifts (eg, buttock firming), skin firming (eg, laxity treatment to firm the skin of the face or body, eg, face, neck, chest , arms, thighs, abdomen, buttocks, etc.), scar reduction, burn treatment, tattoo removal veins, vein removal, vein reduction, sweat gland treatment, excessive sweating treatment, freckle removal, acne treatment and acne removal. Several embodiments of the present invention are particularly preferred as they include one, more or all of the following advantages: faster treatment time, (ii) reduction in pain during treatment, (iii) reduction in pain after treatment, (iv) less recovery time, (v) more efficient processing, (vi) greater customer satisfaction, (vii) less energy to perform processing, and/or (viii) a larger processing area when wobbling focal regions.

[0012] In accordance with various embodiments, a cosmetic system and/or ultrasonic treatment method may non-invasively provide one or a plurality of wobbling cosmetic treatment zones and/or thermal coagulation points in which ultrasound is focused at one or more locations in the treatment area in tissue below the surface. skin, and their movement is carried out by changing the frequency (for example, using frequency modulation). Some systems and methods provide cosmetic treatment at different locations in the tissue, such as at different depths, heights, widths and/or positions. In one embodiment, the method and system include a plurality of depth/height/width transducer systems configured to provide sonication to one or more areas of interest, e.g., between at least one depth of treatment area of interest and/or subcutaneous area of interest. In one embodiment, the method and system include a transducer system configured to provide sonication to more than one region of interest, such as between at least two points at different locations (such as fixed or variable depth, height, width, and/or orientation, etc.) in the tissue region of interest. In some embodiments, the beam can be split to focus on two, three, four, or more focal points (e.g., multiple focal points, multiple focal points) for cosmetic treatment of areas and/or for imaging in a tissue region of interest. The position and/or position of the focal point wobble may be located axially, transversely, or otherwise within the fabric. Some embodiments can be configured to be spatially controlled, for example, by locating and/or wobbling the focus point, changing the distance from the transducer to the reflective surface, and/or changing the angles of energy focused or unfocused in the region of interest, and/or made with the possibility of periodic control, for example, by controlling changes in the frequency, amplitude and time of the movement of the transducer. In some embodiments, the position and/or wobble position of a plurality of treatment zones or focus points is provided by polarization, phase polarization, bi-phase polarization, and/or multi-phase polarization. In some embodiments, the position of a plurality of treatment zones or focus points is provided by phasing, for example, in one embodiment, electrical phasing. Due to this, changes in the location of the treatment area, the number, shape, size and/or size of the treatment or treatment zones in the area of interest, as well as the thermal regime can be dynamically controlled over time.

[0013] In accordance with various embodiments, a cosmetic ultrasound system and/or method may provide for the creation of a plurality of cosmetic treatment zones using one or more of frequency modulation, phase modulation, polarization, non-linear acoustics, and/or Fourier transform to create any spatial periodic template with one or more ultrasonic areas. In one embodiment, the system simultaneously or sequentially delivers energy to one or more treatment zones using ceramic polarization. In one embodiment, the polarization pattern is a function of depth of focus and frequency, and the use of odd or even features. In one embodiment, a polarization pattern is applied, which may be a combination of odd or even functions, and which is based on depth of focus and/or frequency. In one embodiment, the method can be used in two or more dimensions to create any spatial periodic pattern. In one embodiment, the ultrasonic beam is split in the axial and transverse direction, which significantly reduces processing time through the use of nonlinear acoustics and Fourier transforms. In one embodiment, modulation from the system and amplitude modulation from the ceramic or transducer can be used to provide multiple treatment zones in the tissue either sequentially or simultaneously.

[0014] In one embodiment, the aesthetic imaging and processing system comprises an ultrasound probe that includes an ultrasound transducer configured to deliver ultrasound therapy to tissue at a plurality of locations at a depth of focus by electronically wobbling a plurality of apertures of a frequency modulated energy beam. In one embodiment, the system includes a control module connected to the ultrasonic probe to control the ultrasonic transducer.

[0015] In one embodiment, the system includes a wobbler configured to provide a variable spacing between a plurality of distinct cosmetic treatment zones. In one embodiment, the sequence of individual cosmetic treatment zones 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 intermediate ranges) with a change in the wobble interval by 1-50% (for example, 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35% 40%, 45% , 50% and any range in between). In one embodiment, the sequence of individual cosmetic treatment zones has a treatment spacing ranging from about 0.01 mm to about 100 mm (e.g., 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 5 mm, 10 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm and 100 mm, as well as any intermediate value ranges) with changing the interval wobble to 1-50% (for example, 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35% 40%, 45%, 50% and any range in between).

[0016] In one embodiment, the system also includes a movement mechanism programmable to provide a constant or variable spacing between a plurality of individual cosmetic treatment zones. In one embodiment, the sequence of individual cosmetic treatment zones has a treatment spacing ranging from about 0.01 mm to about 25 mm (e.g., 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8 , 9, 10, 15, 19 mm or any intermediate range or intermediate value). In one embodiment, the sequence of individual cosmetic treatment zones has a treatment spacing ranging from about 0.01 mm to about 100 mm (e.g., 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8 , 9, 10, 15, 20, 25, 30, 35, 40, 50, 100 mm or any intermediate range or intermediate value). In one embodiment, the treatment zones are provided along a length of approximately 25 mm. In one embodiment, the treatment zones are provided along a length of approximately 50 mm. In various embodiments, treatment zones are provided along a length of 5 mm to 100 mm (e.g., 10 mm, 20 mm, 25 mm, 35 mm, 50 mm, 75 mm, 100 mm, and any values or ranges in between. In various embodiments, zones treatments are provided along a linear and/or curved length.

[0017] For example, in some non-limiting embodiments, the transducers may be configured to operate at 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, from 0.5 mm to 5 mm, from 1.5 mm to 4.5 mm, more than 4.5 mm, more than 6 mm and any value in the ranges of 0.1 mm - 3 mm, 0.1 mm - 4.5 mm, 0.1 mm - 25 mm, 0.1 mm - 100 mm and any intermediate depth values (for example, 6 mm, 10 mm, 13 mm, 15 mm). In some embodiments, tissue is treated at a depth below the skin surface without damaging the skin surface. On the contrary, the therapeutic effect achieved at a depth below the skin surface provides a cosmetic improvement in the appearance of the skin surface. In other embodiments, the implementation of the surface of the skin is treated with ultrasound (for example, at a depth of less than 0.5 mm).

[0018] One of the advantages of the movement mechanism is that it is able to provide more efficient, accurate and error-free use of the ultrasound transducer for imaging and/or therapy purposes. One of the advantages of this type of motion mechanism over conventional fixed arrays of multiple transducers fixed in space in a housing is that the fixed arrays are spaced at a fixed distance from each other. In one embodiment, the transducer module is configured to provide ultrasound therapy acoustic power ranging from about 1 W to about 100 W (e.g., 3-30 W, 7-30 W, 21-33 W) and a frequency from about 1 MHz to about 10 MHz for thermal heating of the tissue in order to ensure coagulation. In one embodiment, the transducer module is configured to provide ultrasound therapy acoustic power ranging from about 1W to about 500W for maximum or average energy (e.g., 3-30W, 7-30W, 21-33W, 100W, 220 W or more) and frequencies from about 1 MHz to about 10 MHz to thermally heat the tissue to promote coagulation. In some embodiments, instantaneous energy is provided. In some embodiments, medium energy is provided. In one embodiment, the acoustic power may be from 1 W to 100 W over a frequency range of about 1 MHz to about 12 MHz (e.g., 1 MHz, 3 MHz, 4 MHz, 4.5 MHz, 7 MHz, 10 MHz, 2- 12 MHz) or from about 10 W to about 50 W in the frequency range from about 3 MHz to about 8 MHz (eg, 3 MHz, 4 MHz, 4.5 MHz, 7 MHz). In one embodiment, the acoustic power may be from 1 W to 500 W over a frequency range of about 1 MHz to about 12 MHz (e.g., 1 MHz, 4 MHz, 7 MHz, 10 MHz, 2-12 MHz) or from about 10 W up to about 220 W in the frequency range from about 3 MHz to about 8 MHz or from 3 MHz to 10 MHz. In one embodiment, the acoustic power and frequencies are about 40 watts at about 4.3 MHz and about 30 watts at about 7.5 MHz. The acoustic energy generated by this acoustic power can be from about 0.01 joule (J) to about 10 J, or from about 2 J to about 5 J. The acoustic energy generated by this acoustic power can be from about 0.01 J to approximately 60,000 J (e.g. volumetric heating, body shaping, submental fat, abdomen and/or flanks, arms, inner thigh, outer thigh, buttocks, abdominal laxity, cellulite), approximately 10 J or from approximately 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 processing power is from 1 kW/cm ² to 100 kW/cm ² , from 15 kW/cm ² to 75 kW/cm ² , from ¹ kW/cm2 to ⁵ kW/cm2, from 500 W/cm2 to ¹⁰ kW/cm2, from ³ kW/cm2 to ¹⁰ kW/ ^cm2 , 15 kW/ ^cm2 to 50 kW/ cm ² , from 20 kW/cm ² to 40 kW/cm ² and/or from 15 kW/cm ² to 35 kW/s m ² .

[0019] In various embodiments, an sonication system for wobbling a plurality of concurrent focal points from an ultrasonic transducer includes an ultrasonic probe and a control module coupled to the ultrasonic probe to control the ultrasonic transducer. The ultrasonic probe contains an ultrasonic transducer with a single transducer element configured to simultaneously apply ultrasound therapy to the tissue in a plurality of places at a certain distance from each other at the depth of focus. The ultrasonic transducer is polarized using at least a first polarization configuration and a second polarization configuration. The control module changes the spacing between spaced places using the wobble of the first focal area and the second focal area in such a way that the wobble by frequency modulation ensures accurate movement of the position of the focusing point of the beam at the places located at some distance from each other.

[0020] In one embodiment, said plurality of locations are arranged in a linear sequence within the cosmetic treatment area, with spaced locations separated by an interval wobbling with frequency change. In one embodiment, the first set of locations are located in the first beauty treatment zone and the second set of locations are located in the second beauty treatment zone, the first zone being different from the second zone. In one embodiment, the ultrasound transducer is configured to apply amplitude modulation ultrasound therapy, wherein multiple parts of the ultrasound transducer are configured to provide ultrasound therapy with multiple acoustic intensity amplitudes, the first amplitude being different from the second amplitude. In one embodiment, at least one part of the ultrasound transducer is configured to provide ultrasound therapy with two or more acoustic intensity amplitudes, wherein the amplitude of the ultrasound therapy provided by the at least one part of the piezoelectric transducer changes over time. In one embodiment, the ultrasonic transducer comprises a piezoelectric material and a plurality of ultrasonic transducer parts configured to create a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the plurality of changes in the piezoelectric material includes at least one of expanding the piezoelectric material and compressing the piezoelectric material. In one embodiment, the ultrasound transducer is configured to apply phase shift ultrasound therapy, wherein a plurality of ultrasonic transducer parts are configured to provide ultrasound therapy with multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the plurality of phases includes discrete phase values. In one embodiment, the ultrasound transducer is configured to apply ultrasound therapy using amplitude modulation, wherein the plurality of parts of the ultrasound transducer are configured to provide ultrasound therapy with multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude, and applying ultrasound therapy in which the plurality of ultrasonic transducer parts are configured to provide ultrasound therapy with a plurality of phases of acoustic intensity, the first phase being different from the second phase. In various embodiments, the ultrasonic treatment is at least one of: facial skin tightening, brow lift, chin lift, skin treatments around the eyes (e.g., paint bags, treatment of infraorbital laxity), wrinkle reduction, cleavage enhancement, skin tightening. buttocks, scar reduction, burn treatment, skin firming (such as treatment of abdominal laxity or treatment of laxity elsewhere), blood vessel reduction, sweat gland treatment, freckle removal, fat treatment, and cellulite treatment. Skin firming by reducing skin laxity is, in some embodiments, performed to treat a patient with excess or loose skin after weight loss, whether such weight loss occurred naturally or the weight loss was due to surgery.

[0021] In various embodiments, an ultrasonic treatment system for use in cosmetic treatment to wobble a plurality of simultaneously existing focal points from an ultrasonic transducer comprises an ultrasonic probe, including a control module configured to change the interval between the first focal zone and the second focal zone by wobble, a switch , configured to control the ultrasonic treatment function to provide ultrasonic treatment, and a mechanism for moving, configured to direct the ultrasonic treatment in at least one pair of simultaneous sequences of individual thermal cosmetic treatment zones, and a transducer module, configured to apply ultrasonic therapy. The transducer module is configured for ultrasonic imaging and ultrasonic processing. The transducer module is configured to be connected to the ultrasonic probe. The transducer module includes an ultrasonic transducer configured to apply ultrasound therapy to tissue at a plurality of locations at a depth of focus. The transducer module is operatively connected to at least one of the switch and the movement mechanism. The control module contains a processor and a display for controlling the converter module.

[0022] In one embodiment, the transducer module is configured to apply ultrasound therapy using amplitude modulation, wherein multiple parts of the transducer module are configured to provide ultrasound therapy with multiple acoustic intensity amplitudes, the first amplitude being different from the second amplitude. In one embodiment, the transducer module is configured to provide ultrasound therapy, wherein multiple portions of the transducer module are configured to provide ultrasound therapy with multiple phases of acoustic intensity, the first phase being different from the second phase.

[0023] In various embodiments, the sonication system for multifocal wobble processing comprises a module containing an ultrasonic transducer. The ultrasonic transducer is configured to simultaneously apply ultrasound therapy to tissue at a plurality of spaced locations in the tissue, wherein the module changes the spacing between the plurality of spaced locations using wobble of the first focal area and the second focal area, thus that wobble by frequency modulation provides accurate movement of the position of the focusing point of the beam in a plurality of spaced places, and the module also contains a connecting guide made with the possibility of detachable connection with a hand probe to provide electronic communication and power transmission between the module and the hand probe.

[0024] In one embodiment, the ultrasound transducer is configured to apply ultrasound therapy using amplitude modulation, wherein a plurality of parts of the ultrasound transducer are configured to provide ultrasound therapy with a plurality of acoustic intensity amplitudes, the first amplitude being different from the second amplitude. In one embodiment, the ultrasound transducer is configured to apply ultrasound therapy, wherein a plurality of parts of the ultrasound transducer are configured to provide ultrasound therapy with a plurality of phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the ultrasonic transducer comprises a piezoelectric material and a plurality of ultrasonic transducer parts configured to create a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, at least one part of the ultrasonic transducer is configured to provide ultrasound therapy with two or more acoustic intensity amplitudes, wherein the amplitude of ultrasound therapy provided by at least one part of the ultrasonic transducer remains constant over time. In one embodiment, the ultrasonic treatment is at least one of a facelift, a brow lift, a chin lift, a skin treatment around the eyes (e.g., paint bags, treatment of infraorbital skin laxity), wrinkle reduction, cleavage skin enhancement, skin tightening. buttocks, scar reduction, burn treatment, tattoo removal, skin firming (eg, treatment of abdominal laxity or firming of skin elsewhere on the body and face, such as excess skin or tissue, such as during or after weight loss, such as on the abdomen, buttocks , thighs, arms and other areas), vein removal, vein reduction, sweat gland treatment, excessive sweating treatment, freckle removal, fat treatment, vaginal rejuvenation and acne treatment.

[0025] In various embodiments, a method for wobbling simultaneously focused ultrasonic treatment beams includes providing an ultrasonic probe comprising an ultrasonic transducer comprising a single transducer element configured to simultaneously apply ultrasound therapy to tissue at a plurality of spaced locations at a depth of focus , and a control module connected to the ultrasonic probe to control the ultrasonic transducer, as well as wobble the interval between the spaced places of the first focus area and the second focus area using frequency modulation to move the position of the ultrasonic focusing point in spaced each other. from other places.

[0026] In one embodiment, the method includes imaging the first focal zone with an ultrasound imaging element. In one embodiment, the method includes imaging the second focal zone with an ultrasound imaging element. In one embodiment, the interval between the first focal zone and the second focal zone is wobbled in the range of 1-50%. In one embodiment, the interval between the first focal zone and the second focal zone is 1.5 mm and is changed by 0.1 mm. In one embodiment, the frequency modulation is carried out in the range of 1-50%. In one embodiment, the ultrasonic treatment is at least one of a facelift, a brow lift, a chin lift, a skin treatment around the eyes (e.g., paint bags, treatment of infraorbital skin laxity), wrinkle reduction, cleavage skin enhancement, skin tightening. buttocks, scar reduction, burn treatment, tattoo removal, skin tightening (e.g. treatment of sagging on the face and body, e.g. treatment of abdominal laxity, skin tightening on other areas of the body and face, e.g. excess skin or tissue, e.g. during or after losing weight, such as on the abdomen, buttocks, thighs, arms and other areas), vein removal, vein reduction, sweat gland treatment, excessive sweating treatment, freckle removal, fat treatment, vaginal rejuvenation and acne treatment.

[0027] In various embodiments, a method for wobbling a focused ultrasound beam includes providing an ultrasound probe comprising one transducer element and a control module, said one transducer element being configured to apply ultrasound therapy to tissue in a focal zone at a depth of focus, the control module being connected to ultrasonic probe to control a single transformation element; and wobble the focal area by frequency modulation to change the size of the focal area in the tissue.

[0028] In one embodiment, the relative position of the focal zone is wobbled in the range of 1-50%. In one embodiment, the second focal zone is simultaneously emitted by one transformation element. In one embodiment, the method includes imaging the focal area with an ultrasound imaging element. In one embodiment, the frequency modulation is carried out in the range of 1-50%.

[0029] In some of the embodiments described herein, the procedure is entirely cosmetic and not medical. For example, in one embodiment, the methods described herein do not need to be performed by a physician, but can be performed in a beauty parlor or other aesthetic institution. In some embodiments, the system may be used for non-invasive cosmetic skin treatment.

[0030] In some embodiments, simultaneous multifocal therapy using multichannel signal mixing is used. In some embodiments, a plurality of therapy channels are used in the processing system to provide electronic focus and/or direction control. For example, a processing system that uses multiple therapy channels to provide electronic focusing and/or direction control can accelerate electronic wobble to either create more thermal coagulation using the same amount of power as other processing devices, or the same thermal coagulation using electronic wobble using less energy than other processing devices.

[0031] In various embodiments, an ultrasound processing system configured to generate a plurality of simultaneously existing focus points from an ultrasound transducer comprises an ultrasound probe comprising an ultrasound transducer with a plurality of transducer elements configured to simultaneously apply ultrasound therapy to tissue in a plurality located on some distance from each other places, and each element of the transformation contains a channel in which the ultrasonic probe has a geometric focus; wherein the ultrasonic probe has a first electronic focus; and wherein the ultrasonic probe has a second electronic focus; a control module connected to the ultrasonic probe for controlling the ultrasonic transducer, the control module changing the spacing between spaced places using the wobble of the first focus area and the second focus area such that the wobble using the drive function moves the position of the focus point beam in places located at some distance from each other.

[0032] In one embodiment, a plurality of locations are arranged in a linear sequence in a cosmetic treatment area, with spaced locations separated. In one embodiment, a first set of seats is located in a first beauty treatment zone and a second set of seats is located in a second beauty treatment zone, the first zone being different from the second zone. In one embodiment, the ultrasound transducer is configured to apply ultrasound therapy, wherein the plurality of parts of the ultrasound transducer are configured to provide ultrasound therapy with a plurality of acoustic intensity amplitudes, the first amplitude being different from the second amplitude. In one embodiment, at least one part of the ultrasound transducer is configured to provide ultrasound therapy with two or more acoustic intensity amplitudes, wherein the amplitude of the ultrasound therapy provided by the at least one part of the piezoelectric transducer changes over time. In one embodiment, the ultrasonic transducer comprises a piezoelectric material and a plurality of ultrasonic transducer parts configured to create a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the plurality of changes in the piezoelectric material includes at least one of expanding the piezoelectric material and compressing the piezoelectric material. In one embodiment, the ultrasound transducer is configured to apply phase shift ultrasound therapy, wherein a plurality of ultrasonic transducer parts are configured to provide ultrasound therapy with multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the plurality of phases includes discrete phase values. In one embodiment, the ultrasound transducer is configured to apply ultrasound therapy using amplitude modulation, wherein a plurality of ultrasonic transducer parts are configured to provide ultrasound therapy with multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude; and applying ultrasound therapy, wherein the plurality of ultrasonic transducer parts are configured to provide ultrasound therapy with a plurality of phases of acoustic intensity, the first phase being different from the second phase.

[0033] In various embodiments, the ultrasonic treatment is at least one of: facial skin tightening, brow lift, chin lift, skin treatments around the eyes (e.g., paint bags, treatment of infraorbital skin laxity), wrinkle reduction, skin improvement in cleavage, buttock lift, scar reduction, burn treatment, skin firming (such as treatment of abdominal laxity, thigh, buttock, arm, neck or other area laxity), blood vessel reduction, sweat gland treatment, freckle removal, fat treatment and treatment cellulite.

[0034] In various embodiments, an ultrasonic treatment system is used in cosmetic treatment to form a plurality of simultaneously existing focal zones from an ultrasonic transducer, said system comprising an ultrasonic probe, including a control module configured to change the spacing between the first focal zone and the second focal zone, a switch configured to control the sonication function to provide sonication; and a movement mechanism configured to guide the ultrasonic treatment in at least one pair of simultaneous sequences of individual thermal beauty treatment zones; and a transducer module configured to apply ultrasound therapy, wherein the transducer module is configured to perform ultrasound imaging and/or ultrasonic treatment, the transducer module is configured to be connected to an ultrasonic probe, the transducer module comprising an ultrasonic transducer configured to simultaneously apply ultrasound therapy to the tissue at a plurality of locations, the transducer module being operably connected to at least one of the switch and the movement mechanism; and wherein the control module includes a processor and a display for controlling the converter module.

[0035] In one embodiment, the transducer module is configured to administer ultrasound therapy, wherein multiple parts of the transducer module are configured to provide ultrasound therapy with multiple acoustic intensity amplitudes, the first amplitude being different from the second amplitude. In one embodiment, the transducer module is configured to provide ultrasound therapy, wherein multiple parts of the transducer module are configured to provide ultrasound therapy with multiple acoustic intensities. In various embodiments, an ultrasound treatment system for providing multifocal treatment using multichannel signal mixing includes a module containing an ultrasonic transducer, the ultrasonic transducer being configured to simultaneously apply ultrasound therapy to tissue at a plurality of spaced locations in the tissue, the module changes the spacing between a plurality of spaced locations between the first focal area and the second focal area such that the mixing of the multi-channel signal ensures accurate movement of the position of the beam focusing point in the plurality of spaced locations, the module also comprising a connecting a guide configured to be releasably connected to the hand probe to provide electronic communication and power transmission between the module and the hand probe. In one embodiment, the ultrasound transducer is configured to apply ultrasound therapy, wherein the plurality of parts of the ultrasound transducer are configured to provide ultrasound therapy with a plurality of acoustic intensity amplitudes, the first amplitude being different from the second amplitude. In one embodiment, the ultrasound transducer is configured to apply ultrasound therapy, wherein a plurality of parts of the ultrasound transducer are configured to provide ultrasound therapy with a plurality of phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the ultrasonic transducer comprises a piezoelectric material and a plurality of ultrasonic transducer parts configured to create a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, at least one part of the ultrasonic transducer is configured to provide ultrasound therapy with two or more acoustic intensity amplitudes, wherein the amplitude of ultrasound therapy provided by at least one part of the ultrasonic transducer remains constant over time. In one embodiment, the ultrasonic treatment is at least one of a facelift, a brow lift, a chin lift, a skin treatment around the eyes (e.g., paint bags, treatment of infraorbital skin laxity), wrinkle reduction, cleavage skin enhancement, skin tightening. buttocks, scar reduction, burn treatment, tattoo removal, skin tightening (e.g., treatment of laxity, treatment of tissue laxity, treatment of abdominal laxity, and any tightening of skin on other areas of the body and face, such as excess skin or tissue, such as during or after weight loss, such as on the abdomen, buttocks, thighs, arms and other areas), vein removal, vein reduction, sweat gland treatment, excessive sweating treatment, freckle removal, fat treatment, vaginal rejuvenation and acne treatment. In various embodiments, a method for generating simultaneously focused ultrasound treatment beams using multi-channel signal mixing includes providing an ultrasound probe comprising an ultrasound transducer comprising a plurality of transducer elements configured to simultaneously apply ultrasound therapy to tissue at a plurality of spaced locations on a plurality of focusing depths, and a control module connected to the ultrasonic probe to control the ultrasonic transducer, as well as changing the interval between the places of the first focal zone located at a certain distance from each other and the second focal zone using multi-channel signal mixing to move the position of the ultrasonic focusing point in the located at some distance from each other places. In one embodiment, the method includes imaging the first focal zone with an ultrasound imaging element. In one embodiment, the method includes imaging the second focal zone with an ultrasound imaging element. In one embodiment, the interval between the first focal zone and the second focal zone is changed in the range of 1-50%. In one embodiment, the interval between the first focal zone and the second focal zone is 1.5 mm and is changed by 0.1 mm. In one embodiment, the spacing between ranges of electric foci is 10-50% of the nominal distance between electric foci. In one embodiment, the ultrasonic treatment is at least one of a facelift, brow lift, chin lift, eye contour treatment, wrinkle reduction, décolleté skin enhancement, buttock lift, scar reduction, burn treatment, tattoo removal, skin firming (such as human tissue strengthening or abdominal laxity treatment), vein removal, vein reduction, sweat gland treatment, excessive sweating treatment, freckle removal, fat treatment, vaginal rejuvenation and acne treatment.

[0036] In various embodiments, a method for generating simultaneously focused ultrasound beams includes providing an ultrasound probe comprising an array of transform elements, and a control module, wherein the array of transform elements is configured to apply ultrasound therapy to tissue in the focal zone at a plurality of foci, wherein the control module is connected with an ultrasonic probe to control the array of conversion elements, as well as moving the focal area.

[0037] In one embodiment, the relative position of the focal zone is moved in the range of 10-50%. In one embodiment, the second focal zone is simultaneously emitted by one transformation element. In one embodiment, the method includes imaging the focal area with an ultrasound imaging element. In one embodiment, the system is configured to perform non-invasive tissue processing. In one embodiment, the method is performed non-invasively to treat tissue.

[0038] In various embodiments, the implementation of ultrasound imaging is used to ensure sufficient acoustic contact during the implementation of the treatment in ultrasound therapy. In various embodiments, ultrasound imaging is used to prevent treatment at an undesirable area on the body, such as bone or an implant. Sound, unlike light, needs a medium to propagate. In one embodiment, the sonication system acoustically transmits ultrasonic energy from the transducer to the body through an acoustic window using a gel. In this embodiment, the gel is a medium that mimics the acoustic impedance properties of the tissue so as to allow efficient energy transfer from the device to the tissue. Unfortunately, the presence of air between the transducer and the tissue makes it impossible to ensure proper communication and thus can lead to insufficient energy transfer of the ultrasound therapy. Ultrasound imaging allows verification of this transmission. Insufficient transmission may appear as shadowed areas or vertical streaks on ultrasound images or as a completely dark image. Even if there is sufficient transmission, tissue or objects such as bone or an implant can cause problems because these objects may have different acoustic impedance and absorption characteristics from those of soft tissues (eg skin, muscle). As a consequence, the presence of objects (such as bone or an implant) between the device and the target therapy focus may result in significant reflections and the possibility of heating at a shallower depth than intended. Objects (such as bones, etc.) that are close to focus can also cause problems because the object reflects and easily absorbs ultrasound from soft tissues. The reflected energy can lead to an inadvertent increase in the energy that is already in the focus of therapy, causing the temperature to rise faster than intended. The energy absorbed by the bone can cause heat or discomfort in the bone.

[0039] In various embodiments, the implementation of the advantages of the present invention include the use of imaging to evaluate the relationship of the ultrasonic therapy beam with the tissue to be treated. In various embodiments, higher resolution imaging is preferred to provide a more detailed image of tissue at and near the target tissue site to be treated. In various embodiments, the present invention improves safety performance, improves operation efficiency, provides a safety and efficiency aspect for volumetric heating devices (e.g., ribbon processing, linear focus processing zone, cylindrical focal line, plane and/or volume, etc. .) to correct the body, submental fat, abdomen and/or flanks, arms, inner thigh, outer thigh, buttocks, laxity, abdominal laxity, etc., provides qualitative and/or quantitative assessment of the relationship, provides image blending ( d) high resolution with link image(s) used to assess out-of-plane obstructions located after focus (e.g. bone, bowel, implants) and/or can be used to reduce the need for equivalent ultrasound specialist skills.

[0040] In various embodiments, the ultrasound processing and imaging system comprises an ultrasound probe comprising an ultrasound therapy transducer configured to apply ultrasound therapy to tissue, an ultrasound imaging transducer configured to image tissue, and an acoustic window, wherein the ultrasound transducer visualization contains a circular array of visualization; wherein the ultrasound imaging transducer comprises a plurality of transmission channels; wherein the ultrasound imaging transducer comprises a plurality of receiving channels; wherein the ultrasound imaging transducer is configured to focus at a location proximate the ultrasound imaging transducer with respect to a distance between the ultrasound imaging transducer and the acoustic window; and a control module connected to the ultrasound probe to control the ultrasound imaging transducer, the ultrasound imaging transducer being configured to probe more than 40% of the acoustic window.

[0041] In various embodiments, the ultrasound processing and imaging system comprises an ultrasound probe comprising an ultrasound therapy transducer configured to apply ultrasound therapy to tissue, an ultrasound imaging transducer configured to image tissue, and an acoustic window, wherein the ultrasound transducer visualization contains a circular array of visualization; wherein the ultrasound imaging transducer comprises a plurality of transmission channels; wherein the ultrasound imaging transducer comprises a plurality of receiving channels; moreover, the ultrasound imaging transducer operates at an imaging frequency of 8 MHz to 50 MHz, and the ultrasound imaging transducer is configured to image tissue at a depth of up to 25 mm (for example, 5 mm, 8 mm, 10 mm, 12 mm, 15 mm, 20 mm) below the surface of the skin; wherein the ultrasound imaging transducer is configured to focus at a location located behind the ultrasound imaging transducer relative to the acoustic window; and a control module connected to the ultrasound probe to control the ultrasound imaging transducer, the ultrasound imaging transducer being configured to probe more than 10% of the acoustic window.

[0042] In various embodiments, the ultrasound processing and imaging system comprises an ultrasound probe comprising an ultrasound therapy transducer configured to apply ultrasound therapy to tissue, an ultrasound imaging transducer configured to image tissue, and an acoustic window, wherein the ultrasound transducer visualization contains a circular or linear array of visualization; wherein the ultrasound imaging transducer comprises a plurality of transmission channels; wherein the ultrasound imaging transducer comprises a plurality of receiving channels; the ultrasound imaging transducer operating at an imaging frequency of 8 MHz to 50 MHz, the ultrasound imaging transducer being capable of imaging tissue up to 25 mm below the skin surface; wherein the ultrasound imaging transducer is configured to focus at a location proximate the ultrasound imaging transducer with respect to a distance between the ultrasound imaging transducer and the acoustic window; and a control module connected to the ultrasound probe to control the ultrasound imaging transducer, the ultrasound imaging transducer being configured to probe more than 15% of the acoustic window.

[0043] In one embodiment, the imaging beam width from the ultrasound imaging transducer is at least 20% of the cross-sectional dimension of the therapy beam width from the ultrasound imaging transducer. In one embodiment, the imaging beam width from the ultrasound imaging transducer is at least 30% of the cross-sectional dimension of the therapy beam width from the ultrasound imaging transducer. In one embodiment, the imaging beam width from the ultrasound imaging transducer is at least 40% of the cross-sectional dimension of the therapy beam width from the ultrasound imaging transducer. In one embodiment, the imaging beam width from the ultrasound imaging transducer is at least 50% of the cross-sectional dimension of the therapy beam width from the ultrasound imaging transducer. In one embodiment, the imaging beam width from the ultrasound imaging transducer is at least 80% of the cross-sectional dimension of the therapy beam width from the ultrasound imaging transducer.

[0044] In one embodiment, the imaging interaction of the ultrasound imaging transducer provides an indication of the interaction for processing by the ultrasound therapy transducer. In one embodiment, the ultrasound imaging transducer is configured to probe more than 80% of the acoustic window. In one embodiment, the ultrasound imaging transducer is configured to probe more than 90% of the acoustic window. In one embodiment, the circular imaging array is located in the ultrasound therapy transducer.

[0045] In one embodiment, the control module controls the ultrasound imaging transducer to perform vector imaging. In one embodiment, the control module controls the ultrasound imaging transducer to perform defocused vector imaging.

[0046] In one embodiment, the ultrasound therapy transducer is configured to treat tissue in a first set of sites that are located in the first cosmetic treatment zone and a second set of sites that are located in the second cosmetic treatment zone, the first zone being different from the second zone. In one embodiment, the ultrasound therapy transducer is configured to apply amplitude modulated ultrasound therapy, wherein a plurality of ultrasound transducer parts are configured to provide ultrasound therapy with multiple acoustic intensity amplitudes, the first amplitude being different from the second amplitude. In one embodiment, at least one part of the ultrasound transducer is configured to provide ultrasound therapy with two or more acoustic intensity amplitudes, wherein the amplitude of the ultrasound therapy provided by the at least one part of the piezoelectric transducer changes over time. In one embodiment, the ultrasonic transducer comprises a piezoelectric material and a plurality of ultrasonic transducer parts configured to create a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the plurality of changes in the piezoelectric material includes at least one of expanding the piezoelectric material and compressing the piezoelectric material. In one embodiment, the ultrasound transducer is configured to apply phase shift ultrasound therapy, wherein a plurality of ultrasonic transducer parts are configured to provide ultrasound therapy with multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the plurality of phases includes discrete phase values. In one embodiment, the ultrasound transducer is configured to apply ultrasound therapy using amplitude modulation, wherein a plurality of ultrasonic transducer parts are configured to provide ultrasound therapy with multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude; and applying ultrasound therapy, wherein the plurality of ultrasonic transducer parts are configured to provide ultrasound therapy with a plurality of phases of acoustic intensity, the first phase being different from the second phase.

[0047] In various embodiments, the ultrasonic treatment is at least one of a facelift, brow lift, chin lift, eye treatment, wrinkle reduction, cleavage skin enhancement, buttock lift, scar reduction, burn treatment, skin firming (eg, treatment of abdominal laxity), reduction of blood vessels, sweat gland treatment, freckle removal, fat treatment, and cellulite treatment.

[0048] In various embodiments, a method for confirming an interaction between an ultrasound probe and tissue to be treated includes providing an ultrasound probe comprising an acoustic window, an ultrasound transducer comprising an ultrasound therapy transformation element configured to apply ultrasound therapy to tissue, a plurality of imaging transformation elements in a tissue imaging array and a control module connected to the ultrasound probe to control the ultrasound transducer, and probing at least 20% of the acoustic window with the imaging beam from the plurality of imaging transformation elements.

[0049] In one embodiment, a plurality of imaging transform elements probe at least 30% of the acoustic window. In one embodiment, a plurality of rendering transform elements probe at least 40% of the acoustic window. In one embodiment, a plurality of rendering transform elements probe at least 50% of the acoustic window.

[0050] In one embodiment, a plurality of rendering transform elements probe at least 60% of the acoustic window. In one embodiment, a plurality of render transform elements probe at least 70% of the acoustic window. In one embodiment, the method also includes vector rendering. In one embodiment, the method also includes defocused vector rendering. In one embodiment, the method also includes rendering a first focal zone in tissue with a plurality of rendering transform elements. In one embodiment, the method also includes rendering a second focal zone in tissue with a plurality of rendering transform elements. In various embodiments, the ultrasonic treatment is at least one of a facelift, brow lift, chin lift, eye contour treatment, wrinkle reduction, decollete skin enhancement, buttock lift, scar reduction, burn treatment, tattoo removal, skin firming (such as laxity treatment), vein removal, vein reduction, sweat gland treatment, excessive sweating treatment, freckle removal, fat treatment, vaginal rejuvenation and acne treatment.

[0051] In some of the embodiments described herein, the procedure is entirely cosmetic and not medical. For example, in one embodiment, the methods described herein do not need to be performed by a physician, but can be performed in a beauty parlor or other aesthetic institution. In some embodiments, the system may be used for non-invasive cosmetic skin treatment.

[0052] In some embodiments, the present invention provides systems and methods that enhance ultrasound imaging of tissue during movement, such as when an imaging transducer is located on the movement mechanism. In various embodiments, a higher resolution is achieved. In various embodiments, a better imaging signal is obtained. In various embodiments, ultrasound imaging is used with tissue therapeutic treatment.

[0053] In various embodiments, an ultrasound processing and imaging system configured to reduce imaging misalignment comprises an ultrasound probe comprising an ultrasound therapy transducer configured to apply ultrasound therapy to tissue, an ultrasound imaging transducer configured to image tissue, and a movement mechanism for moving the ultrasound imaging transducer in the first direction and in the second direction. In one embodiment, the ultrasound imaging transducer is mechanically attached to the movement mechanism. In one embodiment, the first direction is linear. In one embodiment, the second direction is linear. In one embodiment, the first direction is parallel to the second direction. In one embodiment, the first direction is opposite to the second direction. In one embodiment, the ultrasound imaging transducer is configured to generate an image with a first order of focal zones (f1, f2) when moving in the first direction, the ultrasound imaging transducer is configured to generate an image with a second order of focal zones (f2, f1) when moving in the second direction, and the spatial registration between the imaging in the first direction and the imaging in the second direction is improved by staggering the trigger locations. In one embodiment, a control module is connected to an ultrasound probe to control an ultrasound imaging transducer.

[0054] In various embodiments, an ultrasound processing and imaging system configured to reduce imaging misalignment comprises an ultrasound probe comprising an ultrasound therapy transducer configured to apply ultrasound therapy to tissue, an ultrasound imaging transducer configured to image tissue, and a movement mechanism for moving the ultrasound imaging transducer in the first direction and in the second direction. In one embodiment, the ultrasound imaging transducer is mechanically attached to the motion mechanism, the first direction being linear, the second direction being linear, the first direction being parallel to the second direction, the first direction being opposite the second direction, the ultrasound imaging transducer being configured to form an image with the first order of focal zones (f1, f2, f3, f4) when moving in the first direction, and the ultrasound transducer is configured to form an image with the second order of focal zones (f4, f3, f2, f1) when moving in the second direction, wherein the spatial registration between imaging in the first direction and imaging in the second direction is improved by staggering the trigger locations, wherein the imaging system uses a sequence of the following two consecutive A-lines with a continuously following sequence (line 1: f1, f2, f3, f4; line 2: f4, f3, f2, f1); and a control module connected to the ultrasound probe to control the ultrasound imaging transducer.

[0055] In various embodiments, an ultrasound processing and imaging system configured to reduce imaging misalignment comprises an ultrasound probe comprising an ultrasound therapy transducer configured to apply ultrasound therapy to tissue, an ultrasound imaging transducer configured to image tissue, and a movement mechanism for moving the ultrasound imaging transducer in the first direction and in the second direction. In one embodiment, the ultrasound imaging transducer is mechanically attached to the movement mechanism. In one embodiment, the first direction is opposite to the second direction. In one embodiment, the ultrasound imaging transducer is configured to generate an image with a focal zone order (f1, ..., fN) where N > 1 as it moves in the first direction. In one embodiment, the ultrasound imaging transducer is configured to generate an image with a second order of focal zones (fN, ..., f1) while moving in the second direction. In one embodiment, spatial registration between imaging in the first direction and imaging in the second direction is improved by staggering the trigger locations. In one embodiment, the imaging system uses sequencing for focal area depending on direction, interleaved between (f1-...-fN) and (fN-...-f1) on successive A-lines; and the control module is connected to the ultrasonic probe to control the transducer for ultrasonic imaging.

[0056] In one embodiment, the first direction of motion of the transducer is any one or more of the group consisting of: linear, rotational, and curvilinear motion. In one embodiment, the second direction is the reverse of the first direction. In one embodiment, movement in the first direction occurs in multiple dimensions, and movement in the second direction is the reverse of movement in the first direction. In one embodiment, the ultrasound imaging transducer is configured to generate an image with a first order of focal zones specified as (f1, ..., fN) where N > 1. In one embodiment, the ultrasound therapy transducer is configured to process tissue in a first set of locations that are located in the first beauty treatment area and a second set of locations that are located in the second beauty treatment area, the first area being different from the second area. In one embodiment, the ultrasound therapy transducer is configured to apply amplitude modulated ultrasound therapy, wherein a plurality of ultrasound transducer parts are configured to provide ultrasound therapy with multiple acoustic intensity amplitudes, the first amplitude being different from the second amplitude. In one embodiment, at least one part of the ultrasound transducer is configured to provide ultrasound therapy with two or more acoustic intensity amplitudes, wherein the amplitude of the ultrasound therapy provided by the at least one part of the piezoelectric transducer changes over time. In one embodiment, the ultrasonic transducer comprises a piezoelectric material, and a plurality of parts of the ultrasonic transducer are configured to create a plurality of corresponding changes in the piezoelectric material in response to an electric field applied to the ultrasonic transducer. In one embodiment, the plurality of changes in the piezoelectric material includes at least one of expanding the piezoelectric material and compressing the piezoelectric material. In one embodiment, the ultrasound transducer is configured to apply phase shift ultrasound therapy, wherein a plurality of ultrasonic transducer parts are configured to provide ultrasound therapy with multiple phases of acoustic intensity, the first phase being different from the second phase. In one embodiment, the plurality of phases includes discrete phase values. In one embodiment, the ultrasound transducer is configured to apply ultrasound therapy using amplitude modulation, wherein a plurality of ultrasonic transducer parts are configured to provide ultrasound therapy with multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude; and applying ultrasound therapy, wherein the plurality of ultrasonic transducer parts are configured to provide ultrasound therapy with a plurality of phases of acoustic intensity, the first phase being different from the second phase. In various embodiments, the ultrasonic treatment is at least one of: facial skin tightening, brow lift, chin lift, eye treatment, wrinkle reduction, decollete skin enhancement, buttock lift, scar reduction, burn treatment, skin firming (eg, laxity treatment), blood vessel reduction, sweat gland treatment, freckle removal, fat treatment, cellulite treatment, vaginal rejuvenation, and acne treatment.

[0057] In various embodiments, a method for reducing imaging misalignment during movement of the ultrasound probe includes staggering spatial registration trigger locations between imaging in a first direction and imaging in a second direction with an ultrasound probe, the ultrasound probe comprising an ultrasound therapy transducer configured with the possibility of applying ultrasound therapy to tissue, an ultrasound imaging transducer configured to image the tissue, and a movement mechanism for moving the ultrasound imaging transducer in a first direction and in a second direction, wherein the ultrasound imaging transducer is mechanically attached to the movement mechanism, the first direction being opposite to the second direction, wherein the transducer for ultrasound imaging is configured to form an image with the order focal zones (f1, ..., fN), where N > 1, and the transducer for ultrasound imaging is configured to form an image with the first order of focal zones (f1, ..., fN) when moving in the first direction, and the transducer for ultrasound imaging is configured to form an image with a second order of focal zones (fN, ..., f1) when moving in the second direction.

[0058] In one embodiment, N = any number from the group consisting of: 2, 3, 4, 5, 6, 7, 8, 9, and 10. In one embodiment, N = 4. In various embodiments, sonication is is at least one of facial skin tightening, brow lift, chin lift, eye treatment, wrinkle reduction, decollete skin enhancement, buttock lift, scar reduction, burn treatment, tattoo removal, skin firming (e.g., abdominal laxity), vein removal, vein reduction, sweat gland treatment, excessive sweating treatment, freckle removal, fat treatment, vaginal rejuvenation and acne treatment.

[0059] The methods summarized above and below describe in more detail certain actions taken by the practitioner; however, it should be understood that they may also include third party instruction regarding these activities. Thus, actions such as "energy beam wobble" include "instructing to wobble an energy beam".

[0060] In some embodiments, the system comprises various features that are present as individual features (as opposed to multiple features). For example, in one embodiment, the system comprises a single transform element that creates two concurrent processing focus points that wobble. Many features or components are presented in alternative embodiments. In various embodiments, the system comprises, essentially consists of, or consists of one, two, three, or more embodiments of any of the features or components described herein. In some embodiments, a feature or component is not included and may be excluded from a particular claim, resulting in the system not including such feature or component.

[0061] In addition, the scope will be obvious from the description given in this document. It should be understood that the description and specific examples are for illustrative purposes only and are not intended to limit the scope of the embodiments disclosed herein.

Brief description of the drawings

[0062] The drawings described herein are for illustrative purposes only and are not intended to limit the scope of the present invention in any way. Embodiments of the present invention will become clearer from the detailed description and the accompanying drawings, in which:

[0063] FIG. 1A is a schematic illustration of an ultrasonic system according to various embodiments of the present invention.

[0064] FIG. 1B is a schematic illustration of an ultrasonic system according to various embodiments of the present invention.

[0065] FIG. 1C is a schematic illustration of an ultrasonic system according to various embodiments of the present invention.

[0066] FIG. 2 is a schematic illustration of an ultrasound system interacting with a region of interest in accordance with various embodiments of the present invention.

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

[0068] FIG. 4 is a partial longitudinal section through an ultrasound system according to various embodiments of the present invention.

[0069] FIG. 5 is a table illustrating the division of foci for apertures with different spatial frequencies according to various embodiments of the present invention.

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

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

[0072] FIG. 8 is a schematic representation of the spatial frequency aperture polarization that can be changed by channel excitation in accordance with various embodiments of the present invention.

[0073] FIG. 9 is a schematic representation of a spatial frequency polarized ceramic that can be changed by excitation of channels spanning two polarized regions of the ceramic, in accordance with various embodiments of the present invention.

[0074] FIG. 10 is a schematic representation of an embodiment of an array transducer with a transducer for rendering.

[0075] FIG. 11 is a schematic representation of an embodiment of the array transducer of FIG. 10 with mechanical focus, first electronic focus and second electric focus.

[0076] FIG. 12 is a schematic representation of an embodiment of a treatment intensity map with two foci at 15 mm and 17 mm.

[0077] FIG. 13 is a schematic representation of an embodiment of a processing intensity map with two foci at 15 mm and 19 mm.

[0078] FIG. 14 is a schematic cross-sectional view of the difference between the sizes of an ultrasound therapy beam and an ultrasound imaging beam according to various embodiments of the present invention.

[0079] FIG. 15 is a schematic representation of a line array according to various embodiments of the present invention.

[0080] FIG. 16 is a schematic representation of a circular array according to various embodiments of the present invention.

[0081] FIG. 17 is a schematic representation of a circular array versus a linear array according to various embodiments of the present invention.

[0082] FIG. 18 is a schematic representation of a circular array with a virtual focus behind the array according to various embodiments of the present invention.

[0083] FIG. 19 is a schematic representation of a circular array with a virtual focus between the array and the acoustic window according to various embodiments of the present invention.

[0084] FIG. 20 is a schematic representation of the transmit-receive vector time sequence for conventional B-mode imaging in accordance with various embodiments of the present invention.

[0085] FIG. 21 is a schematic representation of an interleaved imaging approach according to various embodiments of the present invention.

[0086] FIG. 22 is a schematic representation of an imaging approach using synthetic aperture transmission and reception methods in accordance with various embodiments of the present invention.

[0087] FIG. 23 is a schematic representation of a diagnostic ultrasound imaging system in accordance with various embodiments of the present invention.

[0088] FIG. 24 is a schematic representation of bi-directional imaging at the same lateral location according to various embodiments of the present invention.

[0089] FIG. 25 is a schematic representation of the determination of the sequence for the focal zone depending on the direction according to various embodiments of the present invention.

[0090] FIG. 26 is a schematic representation of focal area sequencing versus direction with different trigger locations in accordance with various embodiments of the present invention.

[0091] FIG. 27 is a schematic representation of the determination of the sequence for the focal zone depending on the direction, interleaved between (f1-f2-f3-f4) and (f4-f3-f2-f1) on successive A-lines according to various embodiments of the present invention.

[0092] FIG. 28 are schematic representations of a transducer viewed from the convex side, side cross-section, and concave side, in accordance with various embodiments of the present invention.

[0093] FIG. 29 are schematic representations of a transducer viewed from the convex side, side cross-section, and concave side, in accordance with various embodiments of the present invention.

[0094] FIG. 30 are schematic representations of a transducer as viewed from the convex side, side cross-section, and concave side, in accordance with various embodiments of the present invention.

[0095] FIG. 31 are schematic representations of the transducer as viewed from the convex side, side cross section, and concave side of various embodiments of the present invention.

[0096] FIG. 32 is a schematic representation of a transducer as viewed from the convex side, side cross-section, and concave side, in accordance with various embodiments of the present invention.

[0097] FIG. 33 are schematic representations of a transducer viewed from the convex side, side cross-section, and concave side, in accordance with various embodiments of the present invention.

Implementation of the invention

[0098] The following description contains exemplary embodiments and is not intended to limit the present invention or its teachings, application, or use. It should be noted that throughout the drawings, reference numerals designate the same or corresponding parts and features. The description of the specific examples given in the various embodiments of the present invention is for illustrative purposes only and is not intended to limit the scope of the invention disclosed herein. In addition, the listing of many embodiments having these features is not intended to exclude other embodiments having additional features, or other embodiments that include various combinations of these features. In addition, features in one embodiment (eg, in one figure) may be combined with the descriptions (and figures) of other embodiments.

[0099] In various embodiments, systems and methods for ultrasonic tissue treatment are adapted and/or configured to provide cosmetic treatment. In some embodiments, devices and methods for directing ultrasound therapy to a single focal point or simultaneously to multiple focal points using ultrasound imaging to confirm sufficient acoustic contact with the treatment area to increase efficiency or provide increased correlation between movement in the first and second directions in cosmetic imaging. and/or medical procedures are provided in several embodiments. In some embodiments, devices and methods for using ultrasound imaging to confirm sufficient acoustic contact with the treatment area to improve efficiency and safety in directing ultrasound therapy to a single focal point or multiple focal points simultaneously in cosmetic and/or medical procedures are provided in several embodiments. In some embodiments, ultrasound imaging enhancement devices and methods provide better correlation between movement in the first and second directions in imaging. Embodiments of the present invention provide better imaging correlation between the first driving direction and the second driving direction (eg, better correlation between left and right moving images). Enhanced ultrasound imaging devices and methods enhance the performance of a B-mode imaging accelerator (eg, 1.5, 2, 3, 5 times the scan speed). In various embodiments, tissue under the skin or even on the surface of the skin, such as the epidermis, dermis, fascia, muscle, fat, superficial muscular aponeurotic system (SMAS), is non-invasively treated using ultrasonic energy. The ultrasound energy may be focused at one or more treatment points and/or zones, may be defocused and/or defocused, and may be applied to an area of interest comprising at least one of epidermis, dermis, hypodermis, fascia, muscle, fat, cellulite and SMAS, to achieve a cosmetic and/or therapeutic effect. In various embodiments, the systems and/or methods provide non-invasive dermatological tissue treatment by heat treatment, coagulation, ablation, and/or strengthening. In some embodiments disclosed herein, non-invasive ultrasound is used to achieve one or more of the following: facial skin tightening, brow lift, chin lift, eye contour treatments (e.g., paint bags, infraorbital laxity treatment), wrinkle reduction , fat reduction (eg, treatment of adipose tissue and/or cellulite), anti-cellulite treatment (eg, pitted or non-pitted female gynoid lipodystrophy), cleavage enhancement (eg, upper chest), lifts buttocks (e.g. buttock firming), skin laxity treatment (e.g. tissue treatment to firm or abdominal laxity), scar reduction, burn treatment, tattoo removal, vein removal, vein reduction, sweat gland treatment, excessive sweating treatment, freckle removal , acne treatment and acne removal. In one embodiment, fat reduction is achieved. In various embodiments, reduction in cellulite (e.g., pitted or non-pitted gynoid lipodystrophy) or improvement in one or more characteristics (such as pits, nodules, orange peel appearance, etc.) is as high as about 10-20% 20 -40%, 40-60%, 60-80% or higher (also covering the above ranges) compared to, for example, untreated fabric. In one embodiment, the décolleté area is treated. In some embodiments, two, three, or more beneficial effects are achieved during a single treatment session, and they can be achieved simultaneously.

[0100] Various embodiments of the present invention relate to devices or methods for controlling the supply of energy to tissue. In various embodiments, various forms of energy may include acoustic, ultrasonic, light, laser, radio frequency (RF), microwave, electromagnetic, radiation, thermal, cryogenic, electron beam, photon-based, magnetic, magnetic resonance, and/or other forms. energy. Various embodiments of the present invention relate to devices or methods for splitting a beam of ultrasonic energy into multiple beams. In various embodiments, devices or methods can be used to alter the delivery of ultrasonic acoustic energy in any procedure such as, but not limited to, ultrasound therapy, ultrasound diagnostics, ultrasonic welding, any application involving the transmission of mechanical waves into an object, and other procedures. . As a rule, in ultrasound therapy, effects on tissue are achieved by concentrating acoustic energy using aperture focusing techniques. In some cases, High Intensity Focused Ultrasound (HIFU) is used in this way for therapeutic purposes. In one embodiment, the effect on tissue produced by applying ultrasonic therapy to a certain depth may be referred to as creating a thermal coagulation point (TCP). In some embodiments, the implementation of the zone may include one point. In some embodiments, the zone is a line, plane, spherical, elliptical, cubic, or other one-, two-, or three-dimensional shape. It is through the creation of TCPs in specific locations that thermal and/or mechanical tissue ablation can occur non-invasively or remotely. In some embodiments, sonication does not include cavity formation and/or shock wave generation. In some embodiments, the implementation of ultrasonic treatment includes the formation of cavities and/or the creation of a shock wave.

[0101] In one embodiment, TCPs can be created as a linear or substantially linear, curved or substantially curved zone or sequence in which each individual TCP is separated from its adjacent TCP by a processing interval. In one embodiment, a plurality of TCP sequences may be generated in a processing area. For example, TCPs may be formed along a first sequence and a second sequence separated by a processing distance from the first sequence. While ultrasound treatment can be performed by generating individual TCPs as a sequence and sequences of individual TCPs, it may be desirable to reduce the processing time and the associated risk of pain and/or discomfort experienced by the patient. Therapy time can be reduced by the simultaneous, near-simultaneous or sequential generation of multiple TCPs. In some embodiments, processing time can be reduced by 10%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80 % or more by creating multiple TCPs.

[0102] Various embodiments of the present invention eliminate potential problems caused by the use of ultrasound therapy. In various embodiments, the implementation is achieved by reducing the implementation time of the formation of TCP to provide the desired cosmetic and/or therapeutic treatment of the target tissue for the desired clinical method. In various embodiments, the target tissue is, but is not limited to, any of the skin, eyelids, eyelashes, eyebrow, lacrimal caruncle, crow's feet (wrinkles at the corners of the eyes), wrinkles, eye, nose, mouth (e.g., nasolabial fold, lip wrinkles), tongue, tooth, gums, ears, brain, heart, lungs, ribs, abdomen (for example, with abdominal laxity), stomach, liver, kidneys, uterus, breast, vagina, prostate, testicles, glands, thyroid glands, internal organs, hair, muscle, bone, ligaments, cartilage, fat, fat (labuli), adipose tissue, subcutaneous tissue, implanted tissue, implanted organ, lymphoid tissue, tumor, cyst, abscess, part of a nerve, or any combination thereof.

[0103] Various embodiments of ultrasonic processing and/or imaging devices are described in U.S. Patent Application No. 12/996,616, published as U.S. Publication No. 2011-0112405 A1 dated May 12, 2011, which is the U.S. national phase according to 35 U.S.C. § 371 of International Application No. PCT/US2009/046475, filed on June 5, 2009, and published in English on December 10, 2009, which claims priority over U.S. Provisional Application No. 61/059,477, filed on June 6, 2008, each of which incorporated herein by reference in its entirety. Various embodiments of a device for ultrasonic processing and/or imaging are described in US application No. 14/193,234, which is published in US publication No. 2014/0257145 dated September 11, 2014, which is fully incorporated into this description by reference. Various embodiments of an ultrasonic processing and/or imaging device are described in International Application PCT/US15/25581, which was published as WO 2015/160708 on October 22, 2015 with national phase as US Application No. 15/302,436, which was published as Publication US No. 2017/0028227 dated February 2, 2017, each of these documents is fully incorporated into the present description by reference.

System overview

[0104] As shown in the illustrations presented in FIG. 1A, 1B, and 1C, various embodiments of the ultrasound system 20 include a handheld probe (eg, transducer) 100, a module (eg, transducer module, cartridge, probe) 200, and a controller (eg, console) 300. In some embodiments, console 300 includes a communication system (e.g., Wi-Fi, Bluetooth, modem, etc.) to communicate with another member, manufacturer, supplier, service provider, the Internet, and/or the cloud. In some embodiments, cart 301 provides mobility and/or positioning of system 20 and may include wheels, surfaces for writing or placing components, and/or compartments 302 (e.g., drawers, containers, shelves, etc.), such as for storing or organizing components.In some embodiments, the cart has a power source, such as , a power connection to a battery, and/or one or more cables for connecting power, communications (e.g., Ethernet) to the system 20. In some embodiments, the system 20 s includes cart 301. In some embodiments, system 20 does not include cart 301. Hand probe 100 may be connected to controller 300 via interface 130, which may be a wired or wireless interface. Interface 130 may be connected to hand probe 100 via connector 145. The far end of interface 130 may be connected to a controller connector in circuit 345 (not shown). In one embodiment, interface 130 may transmit controlled power from controller 300 to hand probe 100. In an embodiment, system 20 has multiple imaging channels (e.g., 8 channels) for ultra-clear HD (high definition) imaging of subcutaneous structures to improve imaging. In one embodiment, system 20 includes multiple therapy channels (e.g., 8 channels) and a precision linear drive motor that doubles treatment accuracy as speed increases (e.g., 25%, 40%, 50%, 60%, 75%, 100%). % or more). Together, these features provide one of the most versatile system platforms in the industry and the foundation for unparalleled future capabilities.

[0105] In various embodiments, controller 300 may be configured and/or configured to operate with hand probe 100 and module 200, as well as provide general functionality of the ultrasound system 20. In various embodiments, a plurality of controllers 300, 300', 300 '', etc. can be configured and/or configured to work with multiple hand probes 100, 100', 100'', etc. and/or multiple modules 200, 200', 200'', etc. The controller 300 may be connected to one or more interactive graphic displays 310, which may include a touchscreen monitor and a graphical user interface (GUI) that allows the user to interact with the ultrasound system 20. In one embodiment, a second, smaller and more mobile display that allows the user to conveniently perform positioning and view the processing screen. In one embodiment, a second display is used that allows a user of the system to view the processing screen (eg, on a wall, on a mobile device, large screen, remote screen). In one embodiment, the graphic display 310 includes a touch interface 315 (not shown). In various embodiments, the display 310 allows the setting and display of an operating mode, including equipment activation status, processing parameters, system messages and prompts, and ultrasound images. In various embodiments, controller 300 may be adapted and/or configured to include, for example, a microprocessor with software and input/output devices, systems and devices for controlling electronic and/or mechanical scanning and/or transducer multiplexing and/or module multiplexing. transducer, systems for powering, systems for monitoring, systems for positioning the probe and/or transducers and/or multiplexing transducer modules, and/or systems for processing user input data and recording processing results, among others. In various embodiments, controller 300 may include a system processor and various analog and/or digital control logic circuits, such as one or more microcontrollers, microprocessors, field-programmable gate arrays, computer boards, and related components, including firmware and control software. , which may be capable of interacting with user controls and interface circuits, as well as with I / O circuits and systems for communication, display, interfacing, storage, logging and other applicable functions. System software running in a system process may be adapted and/or configured to control all initialization, timing, level, control, safety control, and other functions of the ultrasound system to achieve user-specified processing goals. In addition, the controller 300 may include various input/output modules such as switches, buttons, etc., which may also be suitably adapted and/or configured to control the operation of the ultrasound system 20.

[0106] In one embodiment, the hand probe 100 includes one or more finger-activated controllers or switches, such as 150 and 160. In various embodiments, one or more heat treatment controllers 160 (eg, switch, button) activate and/or stop processing . In various embodiments, one or more rendering controllers 150 (eg, switch, button) activate and/or stop rendering. In one embodiment, hand probe 100 may include a removable module 200. In other embodiments, module 200 may be non-removable. In various embodiments, module 200 may be mechanically coupled to hand probe 100 by a latch or connector 140. In various embodiments, a connection rail 235 or a plurality of connection rails 235 may be used to provide connection between module 200 and hand probe 100. Module 200 may include one or more ultrasonic transducers 280. In some embodiments, the implementation of the ultrasonic transducer 280 contains one or more ultrasonic elements. Module 200 may include one or more ultrasonic elements. Handheld probe 100 may include imaging-only modules, processing-only modules, imaging and processing modules, and the like. In various embodiments, ultrasonic transducer 280 may be movable in one or more directions 290 within module 200. Transducer 280 connected to the movement mechanism 400. In various embodiments, the movement mechanism comprises zero, one or more bearings, shafts, rods, screws, lead screws 401, angular and linear displacement sensors 402 (for example, an optical sensor for measuring the position of the transducer 280), motors 403 (for example, a stepper motor) to provide accurate and repeatable movement of the transducer 280 within the module 200. In various embodiments, the module 200 may include a transducer 280 that can emit energy through an acoustically transparent element 230. In one embodiment, the control module 300 may be connected to the hand probe 100 via an interface 130 and the graphical user interface 310 may be adapted and/or configured to control the module 200. In one embodiment, the control module 300 may provide power to the handheld probe 100. In one embodiment, the handheld probe 100 may comprise a power source. In one embodiment, switch 150 may be adapted and/or configured to control a tissue imaging function, and switch 160 may be adapted and/or configured to control a tissue processing function. In various embodiments, delivery of radiant energy 50 with a suitable focus depth, distribution, timing, and energy level is provided by module 200 by operating (controlled by control system 300) transducer 280 to achieve the desired therapeutic effect in thermal coagulation zone 550.

[0107] In one embodiment, module 200 may be coupled to hand probe 100. Module 200 may emit and receive energy, such as ultrasonic energy. Module 200 may be electronically coupled to hand probe 100 and such connection may include an interface that provides communication with controller 300. In one embodiment, connector guide 235 may be adapted and/or configured to provide electronic communication between module 200 and hand probe. 100. Module 200 may include a probe and/or transducer with various configurations. For example, module 200 may be adapted and/or configured to attach a combined dual-mode imaging/therapy transducer, coupled or co-located imaging/therapy transducers, separate therapy and imaging probes, and the like. In one embodiment, if the module 200 is inserted into or attached to the hand probe 100, the controller 300 automatically detects it and updates the interactive graphic display 310.

[0108] In some embodiments, the access key 320 (e.g., a secure USB drive, key) is removably connected to the system 20 to enable the operation of the system 20. In various embodiments, the access key is programmed for a specific client and performs a variety of functions, including security systems, access to processing guidance and functionality for specific countries and regions, software updates, transfer of service logs and/or transfer of permission to transfer the next data packet and/or store data. In various embodiments, system 20 has an Internet and/or data connection. In one embodiment, a connection provides a method by which data is transferred between a system 20 data provider and a client. In various embodiments, the data includes permissions to transmit the next data packet, software updates, and service logs. Connectivity is separated according to different model implementations based on how the user's console is connected to the Internet. In one embodiment, a connection according to the Disconnected model includes a console that is disconnected from the Internet and the client does not have access to the Internet. The transfer of permission to transfer the next data packet and software updates is carried out by sending the client the access key (s) (for example, USB drives). In one embodiment, a connection according to the "Semi-Connected" model includes a console that is disconnected from the Internet, but the client has access to the Internet. The transfer of permission to transfer the next data packet, software updates and transfer of the service log is carried out using a personal computer, smartphone or other computing device of the client together with an access key to the system for data transfer. In one embodiment, a connection in accordance with the "Fully Connected" model involves wirelessly connecting the console to the Internet using Wi-Fi, a cellular modem, Bluetooth, or another protocol. The transfer of permission to transfer the next data packet, software updates and the transfer of the service log is carried out directly between the console and the cloud. In various embodiments, system 20 connects to a web portal for streamlined inventory management, on-demand treatment purchase, and business intelligence insights to take the client's aesthetic therapy business to the next level.

[0109] In various embodiments, tissue under the skin or even on the surface of the skin, such as the epidermis, dermis, hypodermis, fascia, and superficial musculoaponeurotic system ("SMAS") and/or muscles, is non-invasively treated using ultrasonic energy. The tissue may also include blood vessels and/or nerves. The ultrasound energy may be focused, unfocused or defocused and may be applied to an area of interest containing at least one of the epidermis, dermis, hypodermis, fascia, and SMAS to achieve a therapeutic effect. FIG. 2 is a schematic illustration of an ultrasound system 20 interacting with an area of interest 10. In various embodiments, tissue layers of the area of interest 10 may be located in any part of the patient's body. In one embodiment, the layers of tissue are in the head and face of the patient. The tissue cross section of region of interest 10 includes skin surface 501, epidermal layer 502, dermal layer 503, fat layer 505, superficial musculoaponeurotic system 507 (hereinafter "SMAS 507"), and muscle layer 509. In addition, tissue may include hypodermis 504, which may include any tissue under the dermal layer 503. The combination of these layers may be collectively referred to as the subcutaneous tissue 510. In addition, in FIG. 2 shows a treatment zone 525 that is below the surface 501. In one embodiment, the surface 501 may be the skin surface of the patient 500. Although the tissue layer therapy embodiment may be used as an example, the system may be applied to any tissue of the body. In various embodiments, the system and/or methods can be used on tissue (including, without limitation, one or a combination of muscle, fascia, SMAS, dermis, epidermis, fat, fat cells, cellulite) that can be called gynoid lipodystrophy (e.g., non-pitted female gynoid lipodystrophy), collagen, skin, blood vessels of the face, neck, head, arms, legs, or any other location on or within the body (including body cavities). In various embodiments, a reduction in cellulite (e.g., non-pitted female gynoid lipodystrophy) of 2%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 75%, 80%, 90%, 95%, including any intermediate ranges.

[0110] As shown in FIG. 2, an embodiment of ultrasonic system 20 includes a hand probe 100, a module 200, and a controller 300. In one embodiment, module 200 includes a transducer 280. FIG. 3 illustrates an embodiment of an ultrasound system 20 with a transducer 280 adapted and/or configured to treat tissue to a depth of focus 278 . In one embodiment, depth of focus 278 is the distance between transducer 280 and the target tissue to be treated. In one embodiment, depth of focus 278 is fixed for a given transducer 280. In one embodiment, depth of focus 278 is variable for a given transducer 280. In one embodiment, transducer 280 is configured to simultaneously process multiple depths below the skin surface (e.g., 1, 5mm, 3.0mm, 4.5mm or other depths).

[0111] As shown in FIG. 4, module 200 may include a transducer 280 that may radiate energy through acoustically transparent element 230. In various embodiments, depth may be focus depth 278. In one embodiment, transducer 280 may have an offset distance 270, which is the distance between transducer 280 and the surface of acoustically transparent element 230. In one embodiment, depth of focus 278 of transducer 280 is a fixed distance from the transducer. In one embodiment, transducer 280 may have a fixed offset distance 270 from transducer to acoustically transparent element 230. In one embodiment, acoustically transparent element 230 is adapted and/or configured to be positioned on module 200 or ultrasound system 20 to contact a surface. 501 leather. In various embodiments, the depth of focus 278 exceeds the offset distance 270 by an amount corresponding to the target area being treated at a tissue depth 279 below the skin surface 501. In various embodiments, when the ultrasound system 20 is in physical contact with the skin surface 501, the tissue depth 279 is the distance between the acoustically transparent element 230 and the target area, measured as the distance from the portion of the hand probe 100 or module surface 200 that is in contact with the skin (with with or without acoustic contact gel, media, etc.), and depth in tissue from the point of contact with the skin surface to the target area. In one embodiment, the depth of focus 278 may correspond to the sum of the distance 270 of the offset (measured to the surface of the acoustically transparent element 230 in contact with the contact medium and/or skin 501) in addition to the depth 279 of the tissue below the skin surface 501 to the target area. In various embodiments, the acoustically transparent element 230 is not used.

[0112] Contact components may include various substances, materials and/or devices to improve the interaction of the transducer 280 or module 200 with the area of interest. For example, the interaction components may comprise an acoustic contact system adapted and/or configured to provide acoustic contact for the transmission of ultrasonic energy and signals. An acoustic contact system with possible connections, such as manifolds, can be used to transmit sound to the area of interest and provide focus with a liquid or fluid filled lens. The interaction system may provide such transmission through the use of one or more contact media, including air, gases, water, liquids, fluids, gels, solid particles, non-gelatinous substances and/or any combination of these or any other medium that allows signals to be transmitted between transducer 280 and region of interest. In one embodiment, one or more contact media are provided within the transducer. In one embodiment, the fluid-filled module 200 contains one or more contact media within the housing. In one embodiment, the fluid-filled module 200 contains one or more couplants within a sealed housing that is separable from the dry portion of the ultrasonic device. In various embodiments, the couplant is used to transfer ultrasonic energy between one or more devices and tissues with a transfer 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.

[0113] In various embodiments, transducer 280 may provide imaging and processing of the area of interest at any suitable tissue depth 279 values. In one embodiment, transducer module 280 is capable of delivering acoustic power in the range of about 1 watt or less, from about 1 watt to about 100 watts, and greater than about 100 watts, such as 200 watts, 300 watts, 400 watts, 500 watts. In one embodiment, transducer module 280 is capable of delivering acoustic energy at a frequency of about 1 MHz or less, from about 1 MHz to about 10 MHz (e.g., 3 MHz, 4 MHz, 4.5 MHz, 7 MHz, 10 MHz), and more than approximately 10 MHz. In one embodiment, the module 200 has a focus depth 278 for processing at a tissue depth 279 approximately 4.5 mm below the skin surface 501. In one embodiment, the module 200 has a focus depth 278 for processing at a tissue depth 279 approximately 3 mm below the skin surface 501. In one embodiment, the module 200 has a focus depth 278 for processing at a tissue depth 279 approximately 1.5 mm below the skin surface 501. Some non-limiting embodiments of transducers 280 or modules 200 may be adapted and/or configured to deliver ultrasonic energy to tissue depths of 1.5 mm, 3 mm, 4.5 mm, 6 mm, 7 mm, less than 3 mm, from 3mm to 4.5mm, 4.5mm to 6mm, over 4.5mm, over 6mm, etc. and anywhere in the range of 0-3mm, 0-4.5mm, 0 -6mm, 0-25mm, 0-100mm, etc., and any depth in between. In one embodiment, the ultrasound system 20 includes two or more transducer modules 280. For example, the first transducer module may treat at a first tissue depth (eg, approximately 4.5 mm), the second transducer module may treat at a second tissue depth (eg, approximately 3 mm), and the third transducer module may treat at a third depth. tissue (for example, about 1.5-2 mm). In one embodiment, at least some or all of the transducer modules may be adapted and/or configured to perform processing at substantially the same depth.

[0114] In various embodiments, varying the number of focus point locations (e.g., at tissue depth 279) for an ultrasound procedure may be advantageous because it allows patient tissue to be treated at different tissue depths, even if the focus depth 278 of transducer 270 is fixed. This can provide synergistic effects and maximize the clinical results of a single treatment session. For example, treatment at multiple depths under a single surface area allows for a larger total volume of tissue to be treated, resulting in enhanced collagen formation and strengthening. In addition, treatment at different depths affects different types of tissue, thus providing different clinical effects, which together provide an improved overall cosmetic result. For example, a superficial treatment may reduce the appearance of wrinkles, while a deeper treatment may result in more collagen production. Similarly, processing at different locations at the same depth or different depths can improve processing.

[0115] While treating a patient at different locations during a single session may be preferable in some embodiments, sequential treatment over time may be desirable in other embodiments. For example, treatment of a patient may be performed by performing treatment under the same surface area at one depth at one time, at a second depth at a second time, and so on. In various embodiments, time may be on the order of nanoseconds, microseconds, milliseconds, seconds, minutes, hours, days, weeks, months, or other time periods. The new collagen obtained from the first treatment may be more sensitive to subsequent treatments that may be required for some indications. Alternatively, treatment at multiple depths under the same surface area during the same session may be preferred, as treatment at one depth may synergistically enhance or complement treatment at another depth (due to, for example, increased blood flow, stimulation of growth factors, hormonal stimulation, etc.). In several embodiments, different transducer modules provide treatment at different depths. In one embodiment, a different depth may be set for a single transducer module. For a single module system, safety features can be used that minimize the risk of selecting the wrong depth.

[0116] In some embodiments, a method for treating the lower region of the face and neck (eg, subchin region) is provided. In some embodiments, a method for treating (eg, softening) chin labial folds is provided. In other embodiments, a method for treating an area of the eye (eg, paint bags, treating infraorbital laxity) is provided. The elimination of upper eyelid flabbiness, as well as periorbital folds and textures, is achieved with some embodiments by performing treatments at different depths. When treated at different locations during the same treatment session, optimal clinical effects (eg softening, firming) can be achieved. In some embodiments, the treatments described herein are non-invasive cosmetic procedures. In some embodiments, these methods may be used in conjunction with invasive procedures, such as surgical facelift or liposuction, when skin firming is required. In various embodiments, these methods can be applied to any part of the body.

[0117] In one embodiment, the transducer module 200 allows sequential processing to a fixed depth at or below the level of the skin surface. In one embodiment, the transducer module allows sequential processing at one, two or more different or fixed depths below the dermal layer. In some embodiments, the transducer module comprises a movement mechanism adapted and/or capable of performing direct sonication as a sequence of discrete thermal exposures (hereinafter referred to as “thermal coagulation points” or “TCPs”) with a fixed depth of focus. In one embodiment, a sequence of individual TCPs has a processing interval 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 in between) with wobble variation in 1-50% increments (e.g. 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45% , 50% and any range between the specified values). For example, the interval may be 1.1 mm or less, 1.5 mm or more, from about 1.1 mm to about 1.5 mm, etc. In one embodiment, the individual TCPs are discrete. In one embodiment, the individual TCPs overlap. In one embodiment, the mechanism for moving is adapted and/or programmable to provide a variable spacing between individual TCPs. In one embodiment, said wobble may be adapted and/or configured to provide a variable spacing between individual TCPs. In some embodiments, the transducer module comprises a mechanism for moving adapted and/or capable of guiding the ultrasonic treatment into a sequence such that the TCPs are formed into linear or substantially linear sequences separated by treatment distance. For example, the converter module may be adapted and/or configured to generate a TCP along a first linear sequence and a second linear sequence separated by a processing distance from the first linear sequence. In one embodiment, the processing distance between adjacent single TCP linear sequences is in the range of about 0.01 mm to about 25 mm. In one embodiment, the processing distance between adjacent single TCP linear sequences is in the range of about 0.01 mm to about 50 mm. For example, the processing distance may be 2 mm or less, 3 mm or more, about 2 mm to about 3 mm, etc. In some embodiments, the transducer module may comprise one or more movement mechanisms 400 adapted and/or configured with the possibility of directing the ultrasonic treatment in the form of a sequence so that the TSR were formed into linear or substantially linear sequences of individual thermal effects, separated by a processing distance from other linear sequences. In one embodiment, the processing is carried out in the first direction 290 (for example, moving forward). In one embodiment, the processing is carried out in a direction opposite to the first direction 290 (for example, moving backwards). In one embodiment, the processing is carried out both in the first direction 290 and in the opposite direction of the first direction (for example, forward and backward). In one embodiment, the same or substantially the same processing distance is used separating linear or substantially linear TCP sequences. In one embodiment, the processing distance separating linear or substantially linear TCP sequences is different or substantially different for different adjacent pairs of linear TCP sequences.

[0118] In one embodiment, first and second plug-in transducer modules are used. In one embodiment, each of the first and second transducer modules is adapted and/or configured for both ultrasound imaging and ultrasound processing. In one embodiment, the transducer module is adapted and/or configured to be processed only. In one embodiment, an imaging transducer may be attached to the handle of a probe or hand probe. The first and second transducer modules are adapted and/or configured to be detachably attached to a hand probe. The first transducer module is adapted and/or configured to perform ultrasound therapy on the first tissue layer, and the second transducer module is adapted and/or configured to perform ultrasound therapy on the second tissue layer. The second tissue layer is at a different depth than the first tissue layer.

[0119] As shown in FIG. 3, in various embodiments, to achieve the desired therapeutic effect, the delivery of radiated energy 50 with a suitable depth of focus 278, distribution, timing and energy level is provided by the module 200 by performing a control system 300 controlled operation of controlled thermal disintegration to treat at least one of epidermis layer 502, dermis layer 503, fat layer 505, SMAS layer 507, muscle layer 509, and/or hypodermis 504. FIG. 3 illustrates one embodiment with a depth that corresponds to the depth to treat the muscle. In various embodiments, the depth may correspond to any tissue, tissue layer, skin, epidermis, dermis, hypodermis, fat, SMAS, muscle, blood vessel, nerve, or other tissue. During operation, module 200 and/or transducer 280 may also be moved mechanically and/or electronically along surface 501 to treat a larger area. Before, during, and after the application of ultrasonic energy 50 to at least one of epidermis layer 502, dermis layer 503, hypodermis 504, fat layer 505, SMAS layer 507, and/or muscle layer 509 can provide control of the treatment area and surrounding structures for planning. and evaluating the results and/or providing feedback to the controller 300 and the user through the graphical interface 310.

[0120] In one embodiment, the ultrasonic system 20 generates ultrasonic energy that is directed and focused below the surface 501. This controlled and focused ultrasonic energy 50 creates a thermal coagulation point or zone (TCP) 550. In one embodiment, the ultrasonic energy 50 creates a cavity in the subcutaneous tissue 510. In various embodiments, the radiated energy 50 acts on the tissue located below the surface 501, namely cuts, cuts, coagulates, microremoves, processes and/or creates a TCP 550 at the site 10 tissue below the surface 501 at a given depth of focus 278. In one embodiment, during sequential processing, transducer 280 is moved in the direction indicated by arrow 290 at specific intervals 295 to create multiple processing zones 254, each of which receives radiated energy 50 to create one or more TCP 550. In one embodiment, arrow 291 illustrates an axis or direction that is orthogonal to arrow 290, and TCP spacing 550 illustrates TCPs that may be orthogonal to the direction of travel of transducer 280. In some embodiments, spaced TCP orientations may be chosen to be any 0-180 degrees relative to the arrow 290. In some embodiments, the orientation of the spaced TCPs may be chosen at any angle from 0-180 degrees depending on the orientation of the polarized regions on the transducer 280.

[0121] In various embodiments, transducer modules may comprise one or more transform elements. The conversion elements may contain a piezoelectrically active material such as lead zirconate titanate (PZT) or any other piezoelectrically active material such as piezoelectric ceramic, crystal, plastic and/or composite material, as well as lithium niobate, lead titanate, barium titanate and/or or lead metaniobate. In various embodiments, in addition to or instead of the piezoelectrically active material, the sensor modules may comprise any other materials adapted and/or capable of generating radiation and/or acoustic energy. In various embodiments, transducer modules may be adapted and/or configured to operate at different frequencies and with different processing depths. Transducer properties may be defined by outer diameter ("OD") and focal length (F _L ). In one embodiment, the transducer may be adapted and/or made with OD = 19 mm and F _L = 15 mm. In other embodiments, other suitable OD and F _L values may be used, such as OD less than about 19 mm, greater than about 19 mm, etc., and F _L less than about 15 mm, greater than about 15 mm, etc. The transducer modules can be adapted and/or configured to apply ultrasonic energy to different target tissue depths. As described above, in some embodiments, transducer modules comprise movement mechanisms adapted and/or capable of directing sonication in a linear or substantially linear sequence of individual TCPs, with a processing interval between individual TCPs. For example, the treatment interval may be approximately 1.1 mm, 1.5 mm, etc. In some embodiments, the transducer modules may also contain movement mechanisms adapted and/or configured to guide the sonication in sequence so that the TCP were formed into linear or substantially linear sequences divided by processing interval. For example, the transducer module may be adapted and/or configured to generate a TCP along a first linear sequence and a second linear sequence separated by a processing interval of about 2 mm to 3 mm from the first linear sequence. In one embodiment, the user may manually move the transducer modules over the surface of the processing area in such a way as to form contiguous linear TCP sequences. In one embodiment, the movement mechanism may automatically move the transducer modules over the surface of the processing area to form contiguous TCP linear sequences.

Aperture Spatial Frequency Analysis and Fourier Transform

[0122] In various embodiments, Fourier analysis and Fourier optics based spatial frequency analysis techniques can be used to improve the effectiveness of a therapeutic treatment. If a system with an impulse response h(t) is driven by an excitation signal x(t), the ratio between the input signal x(t) and the output signal y(t) is a convolution function, which can be expressed as follows:

(1)

(one)

[0123] In various embodiments, the implementation of the Fourier transform can be applied to calculate the convolution using equation (1). The continuous one-dimensional Fourier transform can be expressed as:

(2)

(2)

[0124] where f is frequency, t is time. It can be shown that convolution in the time domain is equivalent to multiplication in the frequency domain:

(3)

(3)

[0125] In various embodiments, the implementation of the Fraunhofer approximation can be used to derive the relationship between the parameters of the opening or aperture of the transducer and the resulting response of the ultrasonic beam. The preparation of the Fraunhofer approximation is described by Joseph Goodman in "Introduction to Fourier Optics" (3rd ed. 2004), which is incorporated herein by reference in its entirety. According to the Fraunhofer approximation, the complex amplitude diagram in the far field, created by a complex aperture, is equal to the two-dimensional Fourier transform of the amplitude and phase of the aperture. In some embodiments, this relationship in optics can be extended to ultrasound, since linear wave equations can be used to represent both light and sound propagation. In the case of optics and/or ultrasound, the two-dimensional Fourier transform can determine the pressure amplitude distribution in the sound wave at the focus of the transducer.

[0126] For a focused system, the variable z, which is the depth, can be replaced by z _f , which is the focal length.

(4a)

(4a)

(4b)

(4b)

[0127] In various embodiments, Fourier optics equalities and Fourier transforms (some of which are listed in Table 1 below) can be used with ultrasonic transducers to determine an intensity distribution appropriate for transducer design. For example, the Fourier transform for the rectangle rect(ax) is a function of the cardinal sine (sinc). As another example, the Fourier transform for a 2D circle with uniform amplitude is a first order Bessel function that can be represented as J ₁ .

Table 1

Aperture function Fourier transform one

2

3

4

five
(pair of two-dimensional transformations)

6

7

[0128] In some embodiments, the implementation of the ultrasonic transducer may have a rectangular aperture with suitable dimensions and focal length. In some embodiments, the implementation of the ultrasonic transducer may have a circular aperture with suitable dimensions and focal length. In one embodiment, the transducer may have a circular aperture with an outer radius of approximately 9.5 mm, an inner diameter of approximately 2 mm, and a focal length of approximately 15 mm. The aperture of the rotary transducer can be described as follows:

(5a)

(5a)

(5b)

(5b)

[0129] For example, in one embodiment, the variable "a" may be approximately 9.5 mm and the variable "b" in equation (5a) may be approximately 2 mm. By applying the Fourier transform to equation (5a), one can obtain an estimate of the pressure distribution in the sound wave at the focus.

(6)

(6)

и

тождественны f_x и f_y из уравнений (4a) и (4b). Из уравнения (6) видно, что распределение давления в звуковой волне преобразователя с круговой апертурой является функцией Бесселя первого порядка. В одном варианте осуществления по существу большая часть энергии сконцентрирована в фокусе (например, на расстоянии 15 мм от апертуры). Ширина основного ультразвукового луча и распределение энергии на удалении от основного луча могут быть выражены как функция рабочей частоты, выраженной с помощью уравнений (4а) и (4b).[0130], where

and

f _x and f _y from equations (4a) and (4b) are identical. Equation (6) shows that the pressure distribution in the sound wave of a circular aperture transducer is a first-order Bessel function. In one embodiment, essentially most of the energy is concentrated at the focus (eg, 15 mm from the aperture). The width of the main ultrasonic beam and the energy distribution away from the main beam can be expressed as a function of the operating frequency expressed using equations (4a) and (4b).

[0131] In various embodiments, two identical or nearly identical beams can be created in focus if the aperture has been modulated (eg, multiplied by) with a correction function. In one embodiment, the cosine function can be applied to a circular aperture as follows:

(7)

(7)

[0132] The energy distribution or beam response at the focus of the modulated aperture according to equation (7) is the convolution of the Fourier transform of two aperture functions:

(8)

(eight)

[0133] Equation (8) can be simplified into a summation of two separate functions by applying the Fourier transform identity for the Dirac delta function (for example, identity 2 in Table 2):

(9)

(nine)

по сравнению с оригинальным, немодулированным лучом. В некоторых вариантах осуществления для достижения требуемого отклика луча может быть использована одна или более других модулирующих функций, таких как синусоидальная функция. В некоторых вариантах осуществления апертуру можно модулировать таким образом, чтобы создать более двух фокусов. Например, можно создать три, четыре, пять и т. д. фокусов. В некоторых вариантах осуществления апертура может быть модулирована таким образом, чтобы фокусы были созданы последовательно или по существу последовательно, а не одновременно.[0134] Equation (9) shows that the two beams at the focus are spatially shifted by ±

compared to the original, unmodulated beam. In some embodiments, one or more other modulating functions, such as a sine function, may be used to achieve the desired beam response. In some embodiments, the aperture may be modulated to create more than two foci. For example, you can create three, four, five, etc. tricks. In some embodiments, the aperture may be modulated such that the foci are created sequentially, or substantially sequentially, rather than simultaneously.

и

в фокусе представлены следующим образом:[0135] In some embodiments, the therapeutic transducer modules comprise mechanisms for moving, configured to direct the ultrasound treatment in a linear or substantially linear sequence of individual TCPs, with a treatment interval between the individual TCPs. For example, the treatment interval may be approximately 1.1 mm, 1.5 mm, etc. In some embodiments, the transducer modules may also contain movement mechanisms configured to guide the ultrasonic treatment in sequence such that linear or stepwise patterns are formed. essentially linear TCP sequences divided by processing interval. For example, the converter module may be configured to generate TCP along the first linear sequence and the second linear sequence separated by a processing interval of approximately 2 mm to 3 mm from the first linear sequence. According to equation (9), simultaneous or substantially simultaneous splitting of the ultrasonic beam can be achieved at the focus (or in front of the focus) if the aperture is modulated using a cosine and/or sinusoidal function with the desired spatial frequency. In one embodiment, two synchronized or nearly synchronized focused beams separated by a 1.1 mm processing interval may be generated in a linear or substantially linear sequence. At an ultrasound frequency of 7 MHz, the wavelength λ for an ultrasonic wave in water is approximately 0.220 mm. Accordingly, the spatial frequencies

and

in focus are as follows:

(10a)

(10a)

(10b)

(10b)

[0136] To determine two foci separated by approximately 1.1 mm, the spatial frequency for aperture modulation is calculated as follows. In the case of using the identities 3 and 4 given in Table 2, the Fourier transform of a sine or cosine function is a Dirac delta function with an argument:

(11a)

(11a)

[0137] In one embodiment, equation (11a) can be solved for k _x if the argument is 0:

(11b)

(11b)

[0138] In addition, x _o can be replaced by half the separation distance (for example, 1.1 mm):

(11c)

(11c)

[0139] In some embodiments, a circular aperture transducer emitting ultrasonic energy at various operating frequencies may be modulated with sine and/or cosine functions at the spatial frequencies listed in Table 2. The modulated transducer aperture may produce simultaneously or substantially simultaneously split a beam with two foci having different separation distances as listed in Table 2. In one embodiment, the transducer may have an internal diameter (OD) of approximately 19 mm and a focal length of approximately 15 mm.

table 2

Separation distance between foci ultrasonic frequency 1.1mm 1.5 mm 2 mm 3 mm 4 MHz 0.60 0.82 1.09 1.63 7 MHz 1.04 1.43 1.90 2.86 10 MHz 1.50 2.04 2.72 3.08

[0140] As shown in Table 2, in some embodiments, the spatial frequency of the modulating aperture function increases with increasing ultrasonic operating frequency for a given focus separation distance. In addition, the spatial frequency increases as the required focal separation distance increases.

[0141] In one embodiment, a higher spatial frequency may result in faster amplitude transitions across the aperture. Due to the processing limitations of the transducer, rapid changes in amplitude across the aperture can lead to a decrease in the effectiveness of the aperture, since there may be a deviation in the amount of sound pressure generated by different parts of the aperture. In one embodiment, the use of spatial frequencies for simultaneous or near-simultaneous beam splitting can reduce the overall focal gain of each beam. As shown in equation (9), the field pressure at the focus of each beam is reduced by half compared to the unmodulated beam. In one embodiment, the sound pressure or intensity of the ultrasound from the aperture can be increased to obtain a similar or substantially similar intensity in the focal plane. However, in one embodiment, the aperture pressure increase may not be limited by the system and/or transducer processing limitations. In one embodiment, an increase in aperture pressure may result in an increase in the overall intensity in the near field, which may increase the likelihood of excessive heating of the tissue(s) that is located in front of the focus. In one embodiment, the possibility of additional heating of the tissue(s) located in front of the focus can be limited or eliminated by using a lower frequency of ultrasonic treatment.

[0142] In one embodiment, applying the modulating aperture function as shown in equation (7) results in the simultaneous or substantially simultaneous creation of two ultrasonic beams at the focus. In various embodiments, the implementation of the ultrasonic beam can be split many times, for example, three, four, five, etc., so as to create many beams at the same time or almost simultaneously. In one embodiment, four equally spaced beams along the same size can be generated by modulating or multiplying the aperture by two separate spatial frequencies:

(12a)

(12a)

(12b)

(12b)

[0143] As shown in equation (12b), the unmodulated beam at the focus can be created at four different locations along the x-axis. In one embodiment, a constant or DC term C1 may be added to the amplitude modulation function to provide energy distribution at the original focal location:

(13a)

(13a)

(13b)

(13b)

[0144] In one embodiment, the aperture modulation according to equations (12) and (13), due to which the beam can be simultaneously or almost simultaneously directed to multiple locations, may have limited applicability due to restrictions associated with the system, material and / or cloth. In one embodiment, due to the possibility of heating the tissue(s) located in front of the focus in the area of treatment, the frequency of ultrasound therapy can be adjusted, for example, reduced, to limit and/or eliminate this possibility. In one embodiment, non-linear methods may be applied at the focus to limit and/or eliminate the possibility of heating the tissue(s) located in front of the focus. In one embodiment, the sound pressure or intensity of the ultrasound from the aperture can be increased to obtain a similar or substantially similar intensity in the focal plane.

[0145] In various embodiments, if the amplitude and phase functions at the aperture can be separated, the two-dimensional Fourier transform of the sound pressure function U(x _1, y ₁ ) can be expressed as the product of the one-dimensional Fourier transform of the two functions in x and y. In various embodiments, it may be desirable to create multiple TCPs in a linear or substantially linear sequence, as well as to create multiple linear sequences simultaneously or almost simultaneously.

Electronic wobble in apertures with splitting into multiple beams using frequency modulation

[0146] In various embodiments, Table 2 illustrates the spatial aperture frequency to achieve a certain distance between two simultaneous foci for a given operating frequency (eg, in various embodiments, 4 MHz, 7 MHz, 10 MHz). Equation (11c) shows that the separation distance between foci is also a function of the operating frequency. For example, in one embodiment, the aperture spatial frequency (k _x ) is fixed at 1.0 mm ^-1 and the operating frequency can be changed. Equation 11c can be rewritten to show how the focal separation distance can be modulated with the operating frequency.

s = (k _x z _f v _c )/(π f _op ) (14)

[0147] where k _x is the spatial frequency in mm ^-1 , z _f is the depth of focus of the aperture in mm, v _c is the speed of ultrasound in the propagation medium (eg water) in mm/μs, and f _op is the operating aperture frequency in MHz. In one embodiment, the following substitution is made in Equation 11c:

λ = v _c / f _op (15)

[0148] As can be seen from equation (14), the focal separation distance is a function of the operating frequency. In addition, the rate of change of the separation distance with respect to the operating frequency is:

ds/df _op = -(k _x z _f v _c )/(π f _op ² ) (16)

[0149] Equation (16) shows that the separation distance decreases as the operating frequency increases. Table 3 (below) shows the rate of change of separation distance versus operating frequency for different spatial frequencies (eg, in various embodiments, 4 MHz, 7 MHz, 10 MHz).

Table 3

° Values derived from Equation (16) [mm/MHz] ultrasonic frequency 1.1mm 1.5 mm 2 mm 3 mm 4 MHz -0.269 -0.367 -0.488 -0.730 7 MHz -0.152 -0.209 -0.278 -0.418 10 MHz -0.107 -0.146 -0.195 -0.221

[0150] As shown in Table 3, as the operating frequency increases, the foci converge, and as the operating frequency decreases, the foci move away from each other without the need for a phase change or mechanical movement of the transducer. This is a unique way of electronically moving the beam to propagate energy without considering the thermal conductivity of the tissue. Benefits include reducing or minimizing maximum temperature and increasing the amount of thermal coagulation on exposure without the need for additional system channels.

[0151] The amount of movement from the main operating frequency can be determined using Equation (14). In one embodiment, the main operating frequency of the aperture is 5 MHz and the focal length is 15 mm. In some embodiments, the operating frequency is referred to as the center frequency of the aperture. In one embodiment, the operating frequency is 5 MHz. In one embodiment, table 4 in FIG. 5 illustrates the number of focus separations for apertures with different spatial frequencies (k _x = 0.5, 1.0, 1.5, 2.0 in mm ⁻¹ ) calculated for a center frequency of 5 MHz. In addition, the spread around the foci is calculated for the center frequency of 5 MHz. In one embodiment, the spacing decreases for higher frequencies relative to 5 MHz and increases for lower frequencies relative to 5 MHz.

[0152] FIG. 6 illustrates the difference in the intervals for all aperture operating frequencies for various values of the aperture spatial frequency. As shown in FIG. 6, the separation distance increases with decreasing frequency.

[0153] In one embodiment, the separation distance is correlated with a frequency of 5 MHz. In one embodiment, one way of estimating electronic wobble with respect to frequency modulation can be defined as matching all movements with an initial separation at 5 MHz. As shown in FIG. 7, the separation distance spread between foci can easily vary by more than 1 mm.

[0154] In various embodiments, the range of possible operating frequencies for a single aperture may be described in terms of transducer bandwidth. In one embodiment, a larger transducer bandwidth results in a wider aperture operating frequency range. The transducer bandwidth can be described as a percentage of the center frequency of the aperture by determining the frequency at which the transmit intensity drops to -3 dB from the maximum transmit intensity. In one embodiment, the top frequency -3dB is denoted f _-3db,H and the bottom frequency -3dB is denoted f-3dB _,L for the transducer aperture response when transmitting. The center frequency -3 dB in [MHz] is described as follows:

f _{-3dB, center} = (f _{-3dB, H} + f _{-3dB, L} )/2 (17)

[0155] The percentage bandwidth to -3 dB is described as follows:

BW _-3dB = 100%* (f _{-3dB, H} - f _{-3dB, L} )/ ((f _{-3dB, H} + f _{-3dB, L} )/2) (18)

[0156] In some embodiments, the increase in operating frequency range possible within a single aperture can be achieved (but not limited to) through the use of protective layers, matching layers, multiple piezoelectric layers, electrical matching, piezoelectric composites, and/or single crystal piezoceramics. In one embodiment, as the transducer bandwidth increases, the range of possible separation distances increases. Table 5 (below) shows how, depending on the bandwidth percentage, the focus separation can vary if the center frequency of the aperture is 5 MHz. The focus separation distance for 5 MHz is 0.72 mm, 1.43 mm, 2.15 mm and 2.86 mm, respectively, for spatial frequency values of 0.5 mm ^-1 , 1.00 mm ^-1 , 1.50 mm ^-1 , 2.00 mm ^-1 . If the spatial frequency at the aperture is 1.50 mm ^-1 and the transducer bandwidth is 60%, then the focal separation distance changes by 1.42 mm, which is greater than the transverse resolution of the beam at 5 MHz.

Table 5

Additional spread around 5 MHz center frequency in [mm] The width of the line k _x \u003d 0.5 mm ^-1 k _x \u003d 1.0 mm ^-1 k _x \u003d 1.5 mm ^-1 k _x = 2.0 mm ^-1 twenty % 0.14 0.29 0.43 0.58 40% 0.30 0.60 0.90 1.19 60% 0.47 0.94 1.42 1.89 80% 0.68 1.36 2.05 2.73 100 % 0.95 1.91 2.86 3.82

[0157] In one embodiment, as the frequency changes, the depth of field will also change as well as the lateral resolution and focal gain. In one embodiment, changing the frequency will also change the depth of field, lateral resolution, and focal gain. Thus, in one embodiment, the intensity at the aperture may vary depending on the target heating rate. In addition, in some embodiments, it may be advantageous to simultaneously apply multiple operating frequencies for immediate or direct distribution of energy. For example, a transmit drive for an aperture may include drive at 4 MHz, 5 MHz, and 6 MHz simultaneously.

Many tricks when changing the spatial frequency of the aperture

[0158] Equation 11c shows that the higher the spatial frequency of the aperture, the greater the separation distance between foci. In one embodiment, the aperture is polarized with a spatial frequency k _x . The spatial frequency can easily be doubled or reduced to zero by connecting separate electrical drive channels that allow 0 degrees or 180 degrees of phase change, as shown in the embodiments of FIG. 8. For example, if the phase in channels 1 to 16 is 0 degrees, then the spatial frequency of the aperture is k _x . In one embodiment, when the phase in each channel changes from 0 to 180 degrees such that it is 0 degrees in odd channels and 180 degrees in even channels, the spatial frequency at the aperture is ½ k _x . In one embodiment, if the phase repeats every two channels such that for channel 1 and channel 2 it is 0 degrees, and for channel 3 and channel 4 it is 180 degrees, etc., the spatial frequency at the aperture is 0 If the phase is 0 degrees for channel 1, 180 degrees for channel 2, 180 degrees for channel 3, 0 degrees for channel 4, and so on, the spatial frequency at the aperture is 2k _x . In this case, seven unique tricks can be created. As indicated in Table 4 (in FIG. 5), if the aperture center frequency is 5 MHz and the aperture frequency is any of 0 mm ^-1 , 0.5 mm ^-1 , 1.0 mm ^-1 or 2.0 mm ^-1 , the respective separation distances are 0 mm, 0.72 mm, 1.43 mm and 2.86 mm, resulting in seven unique focal positions divided by 0.36 mm. In various embodiments, intermediate phase values between 0 degrees and 180 degrees also allow the two foci to be tilted so that a line of focus can be created in the focal plane. Ultimately, tilt, focal position modulation, and frequency modulation provide heating and eventual coagulation along the entire line of approximately 2.86 mm.

[0159] In one embodiment, the polarized ceramic has a spatial frequency of 2k _x as shown in FIG. 9. In this case, each electrical channel spans two polarized regions in a ceramic (eg piezoceramic). If channels 1-8 have the same electrical phase, the spatial frequency of the aperture is 2k _x . If the phase is interleaved such that the odd channels are 0 degrees in phase and the even channels are 180 degrees in phase, the spatial frequency of the aperture is k _x . In one embodiment, this configuration of only two phases is possible on channels that provide four unique foci. In various embodiments, if additional phases are available, the two foci can be tilted to a variety of different focus positions. This configuration limits the number of electronic channels required to obtain multiple focus positions.

Lots of tricks using multi-channel signal mixing

[0160] In some embodiments, a plurality of therapy channels are used in the processing system to provide electronic focusing and/or direction control. For example, a processing system that uses multiple therapy channels to provide electronic focusing and/or direction control can accelerate electronic wobble to either create more thermal coagulation using the same amount of power as other processing devices, or the same thermal coagulation using electronic wobble using less energy than other processing devices. This method expands the range of efficiency and comfort provided by the device. In addition to electronic wobble, multiple therapy channels also provide the ability to move the beam to areas at different depths, so that two conventional transducers such as the DS7-4.5 (7 MHz at 4.5 mm depth) and DS7-3.0 (7 MHz at 3 mm depth) .0 mm) can be replaced by a single device that is moved between two different depths.

[0161] In one embodiment, a transducer 280 with a plurality of therapy channels 281 coupled to allow the beam to move in an axial direction (e.g., in a circular array) typically creates TCP 550 first at a greater depth and then transitions to a shallower depth. In another embodiment, the TCP 550 is created at a shallow depth and then at a greater depth below the surface of the skin. In this case, the creation of TCP 550 occurs sequentially, which leads to an increase in processing time. For example, in one embodiment, if the processing time of the deeper TCP 550 is t _deep and the processing time of the shallower TCP 550 is t _shallow , then the total processing time for these two kinds of TCP 550 is equal to the sum of the two processing times, t _deep plus t _shallow . In one embodiment, the overall processing time is reduced by forming multiple (two or more) TCP 550s while using signal mixing techniques that involve both signal apodization (field ripple) and phase control in each channel. In one embodiment, the total processing time is the largest of t _deep and t _shallow :

[0162] Treatment time, traditional approach: t _treatment = t _deep + t _shallow

[0163] Processing time, signal mixing: t _treatment = max(t _deep , t _shallow )

[0164] In one embodiment, the circular array design 280 enables the therapy beam to be electronically moved in depth (eg, by varying the depth of the TCP 550 below the skin surface). In one embodiment, transducer 280 includes eight circular transducer elements 281 for fixed mechanical focus therapy. FIG. 10 shows a plan view of one embodiment of this circular ceramic array design 280 with an imaging transducer 285 in the center of the bowl. In this embodiment, the therapy rotary transducer 280 comprises eight rings, labeled Tx0-Tx7, corresponding to elements 281. In FIG. 11 shows a side view of the same 8-channel circular transducer 280 with marks denoting the boundaries between the rings. In this embodiment, eight separate excitation sources are connected to separate concentric rings 281. In addition to electrical excitation, a geometric focus 551 and two electronic foci 552, 552' are defined.

[0165] In one embodiment, single values of amplitude "A" and phase "8" are applied for each channel of therapy and the corresponding concentric ring 281 for each focus at a given frequency "ω" of therapy. The excitation function for a channel can be generalized as follows:

[0166] where n is the ring or channel number and m is the focus number.

[0167] In the case of creating a TCP in a geometric focus, the phase is zero and equation (19) can be rewritten as follows:

[0168] where "l" in the index means geometric focus.

[0169] In the case of building a TCP 550 at electronic focus #2, the phase of the rings should be corrected to focus the ultrasound at a spatial point using bowl geometry and time delay estimates. The excitation function can be written in the following form:

[0170] where the "2" in the index means the electronic focus #2, and the angle reflects the required phasing for the ring.

[0171] Now, in the normal case, two TCPs will be created sequentially, and, as a rule, the deeper TCP is created first, and then the TCP at a shallower depth. At the same time, signal mixing allows the two excitation signals to be represented as a single signal, so that both TCPs can be generated at the same time.

[0172] The amplitude and phase on each ring is changed to maintain focus in two places at the same time.

[0173] In some embodiments, the dose delivery time for one focus will be slightly different from the dose delivery time for the second focus. In one embodiment, the excitation may start or end at the focus with the longest dosing time, with the excitation being varied to maintain dosing at two foci at the same time, with Equation (22b) being used at other times. For example, in one embodiment, f _n,1 requires a total dosing time of 30 ms, while f _n,2 requires a total dosing time of 60 ms. Many different excitation scenarios can be used to fulfill these conditions:

[0174] In one embodiment, this concept can also be generalized to the simultaneous use of more than two foci. Suppose the excitation on one ring is as follows:

[0175] where n is the number of the ring, and m is the number of simultaneously applied foci. This generalization to more than two foci allows simultaneous provision of a shallower geometric focus, an electronic focus, and a deeper electronic focus.

[0176] In one embodiment, an experiment was conducted using the simulation of two simultaneously applied foci, which were created in order to show that when this theory is applied, two foci appear. During the simulation, we tried to simultaneously place the focus of therapy at the points of 15 mm and 17 mm. FIG. 12 shows an intensity map in azimuth and depth for this simultaneous firing. This intensity map clearly shows two foci appearing at 15 mm and 17 mm. Another simulation was performed with foci of 15 mm and 19 mm, respectively. FIG. 13 shows the results. In various embodiments, this method can be applied to any array. The array can be circular, linear, or any electronically controlled array for the transducer.

Ultrasound Imaging to Improve Processing in Ultrasound Therapy

[0177] In one embodiment, imaging resolution is improved by electronically focusing on the beam axis when transmitting and receiving signals. In various embodiments, rendering resolution is improved by 10%, 20%, 40%, or 50%, 10%-50%, or any values within the specified ranges. In one embodiment, the increase in imaging resolution may not involve probing as well as interaction between the therapy transducer and the skin, since the cross section of the therapy beam is much wider than the imaging beam on a given tissue surface.

[0178] FIG. 14 illustrates an embodiment of a cross section of a therapy beam 281 from an acoustic window interface therapy transducer 280 compared to a cross section of an imaging beam 286 from an imaging transducer 285. In this figure, transducer 280 moves back and forth across the page. As shown in FIG. 14, the outer diameter of the therapy cross section is significantly larger than the imaging cross section. Analysis using trigonometry and simple ray tracing shows that for a therapy transducer with a 4 MHz therapy beam aimed at a depth of 4.5 mm below the skin surface (DS 4-4.5), the outer diameter of 281 therapy beams is 8 mm , while the outer diameter of the imaging beam 286 would potentially be approximately 0.25 mm. In this case, if a small imaging beam is used to check for proper interaction, only about 0.1% of the therapy beam is probed through the acoustic examination window. In one embodiment, this estimate may be slightly underestimated due to diffractive effects of the therapy beam.

[0179] In one embodiment, the imaging beam 286 is expanded to a majority (e.g., 10%, 15%, 25%, 50%, 75%, 90%, 100%) of the entire image frame to cover most or all of the beam 281 cross section for therapy. In one embodiment, the image is 25 mm wide. If areas are computed and compared (eg slice thickness and width), the image plane only allows approximately 2.5% of the total cross section of the therapy area to be probed in the acoustic window. Although this is an improvement over the original value, coverage is still well below 100%. In various embodiments, imaging provides proper probing (eg, 10%, 15%, 25%, 50%, 75%, 90%, 100%) at the interaction site using a circular array imaging system. In some embodiments, image processing provides a correct interpretation of the operator.

Line array visualization

[0180] In various embodiments, the sonication system includes an imaging module and an imaging array 285. In various embodiments, the render array 285 is a linear array, such as shown in the embodiment of FIG. 15. In one embodiment, a method for determining the amount of acoustic contact between tissue and sonication systems is to use a line array that is oriented in the transducer module such that the beam is electronically controlled and focused along the y and z dimensions. It is orthogonal to the direction of movement carried out by the movement mechanism. In this embodiment, the line array focuses the imaging beam on the imaging plane multiple times as the transducer is moved along the x-axis to generate a high resolution ultrasound image. When the line array is moved along the x-axis, the imaging beam can also be directed and focused at some distance from the imaging plane to better evaluate the interaction of the cross-sectional width therapy beam with tissue. In some cases, this may provide even better spatial definition of areas of insufficient interaction than in the case of a circular array due to the spatial specificity of the imaging beam. This is particularly true if the linear array is a 1.25D, 1.5D, 1.75D, or 2D array.

Circular Array Rendering

[0181] In various embodiments, the sonication system includes an imaging module and an imaging array 285. In various embodiments, the imaging module has multiple (e.g., 2, 4, 8) transmit channels and multiple (e.g., 2, 4, 8) receive channels that operate at a frequency of 8 MHz to 50 MHz (e.g., 8, 9, 10, 12, 15, 20, 22, 25, 28, 30, 40, or 50 MHz, including any bands in between) for skin imaging to a depth of approximately 25 mm. In one embodiment, the imaging module has eight transmit channels and eight receive channels that operate at a frequency of 8 MHz to 50 MHz to image skin to a depth of approximately 25 mm. These eight channels allow for unique imaging aperture designs with features that provide electronic direction control and focus in transmit and receive. One of these types of apertures is a circular array (FIG. 16).

[0182] In some embodiments, the implementation of the circular array 285 contains rings of areas with the same elements that provide electronic focusing along the beam axis. In one embodiment, the mechanically scanned circular array 285 provides superior imaging performance through the use of a more technically advanced electronically controlled line array 285'. This is because the circular array 285 focuses the beam along the beam axis in azimuth and elevation. Radial symmetry produces a high resolution beam with an equivalent beam width. The 285' line array provides electronic focusing in azimuth and mechanical focusing in height, equivalent to a compound lens. Beam resolution in azimuth may match this characteristic for a circular array of 285; at the same time, the height resolution of the beam is inferior to that of the circular array 285 due to the use of a mechanical lens having only one focus depth.

[0183] FIG. 17 shows one embodiment of the height focusing capabilities of the circular array 285 compared to the linear array 285'. Beam width 286 for circular array 285 remains narrow throughout the depth. However, this small beamwidth 286 limits the extent to which the beam can be probed for therapy both before the focus (eg, on tissue interaction) and behind the focus (eg, on bone).

[0184] In one embodiment, circular array 285 is superior to conventional imaging transducers in that it is capable of focusing along the beam axis during transmission and reception. Just as the circular array 285 can be focused into tissue, it can also be effectively focused behind the transducer 285. This focusing of the imaging array 285 behind the transducer ensures that the acoustic energy propagating towards the tissue is defocused, allowing better sensing of the therapy interaction beyond the acoustic window, and also the likelihood of obstructions (eg, bones) behind the therapy focus. FIG. 18 shows an embodiment of virtual focus behind the circular imaging array 285 and effective response in the tissue direction. The defocused beam 286 propagates from the imaging array 285 to the acoustic window in such a way that a significantly higher percentage of sounding is provided (for example, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% 100 %, as well as any intermediate ranges or values) of beam transmission for therapy. Another transmission focus, depending on specific beamwidth and penetration characteristics, can be used to defocus the beam behind the therapy focus. This can be achieved by placing the virtual focus behind or directly in front of the circular array 285 to match the required beamwidth for the point spread function compared to the therapy beam. FIG. 19 shows an embodiment of a therapy beam 286 that propagates rapidly behind the focus, and a slightly wider therapy beam 286 may be required to locate tissues or implants that do not transmit ultrasound energy well (eg, bone, intestines). In some embodiments, the goal is to better probe the acoustic window in front of the therapy focus and tissue behind the therapy focus to ensure safe and effective treatment.

Vector rendering

[0185] In some embodiments, beam defocusing in the acoustic window and behind the focus of therapy is advantageous to check for interactions and the presence of potential obstructions in tissue (eg, bone, gut) or implants. This processed and displayed information can be used by the system operator to make appropriate decisions without the use of conventional visualization. In one embodiment, defocused beam round-trip events are used in conjunction with standard imaging to provide timely information. This form of imaging provides the required frame rate for conventional B-mode imaging and transmit pulses.

[0186] FIG. 20 shows one embodiment of the transmit-receive vector time sequence for conventional B-mode imaging. In standard rendering, transmit-receive events occur when circular array 285 is at the appropriate azimuth location (eg, P1). In one embodiment, the ultrasound imaging and processing system will use 1 to 4 transmission foci per imaging vector to create a high resolution frame. FIG. 20, the position vectors are represented by the symbol "P" with a number. In one embodiment, vector P1 corresponds to three transmissions: TR1, TR2, and TR3. DF1 is a probing pulse to check the correct interaction of the system with the treated tissue. In one embodiment for 25 mm, the scan will consist of 501 vectors that are divided by 0.050 mm for a total imaging width of 25 mm. Transmission and reception events are represented by the symbols "TR" with a number. As shown in FIG. 20, three round trip events are associated with each position, or in other words, each position of the vector corresponds to three transmission foci. In the case of a defocused beam, there is no need to transmit at every position. This is because the beamwidth is much larger than the 0.050 mm sampling interval. Furthermore, in one embodiment, the imaging beamwidth in the acoustic window for defocused transmission is approximately 5 mm, in which case the window may be sampled every 0.5 mm. This is due to the fact that in reality there is no additional information obtained by more accurate discretization. This type of rendering includes an interleaved (eg, overlapped, etc.) rendering method as shown in FIG. 21.

[0187] Shown in FIG. 21 is a vector rendering similar to that shown in FIG. 20 except that at P1 and then every 10 positions thereafter, a defocused vector is obtained. Thus, 501 vectors are still obtained to provide a high resolution image. However, in addition to these 501 vectors, 51 vectors are obtained using defocused transmission to estimate transmission in the acoustic window. The 501 vector and the corresponding round trip events are handled differently than the 51 vectors that are used for transmission estimation. Note that this is only one way to define a vector sequence. Because the high resolution imaging is oversampled across (approximately four to five) beamwidths, it is possible to discard one sequence per position and simply perform defocused imaging. If defocused imaging is used to interpolate between vectors, averaging can be applied. This will provide an assessment of the interaction at shallow depth (eg, in the acoustic window) and deep (eg, behind the focus), as well as assess the safety and effectiveness of energy delivery for therapy in tissues. The type of sequencing is similar to duplex imaging, in which B-mode and Doppler imaging are performed simultaneously.

[0188] In embodiments assuming sufficient transmit sensitivity and receive signal-to-noise ratio, synthesized imaging for the transmit and receive aperture can be used to achieve optimal resolution of the ultrasound image and provides sufficient means to determine if transducer interaction is sufficient. for therapy. FIG. 21 shows an embodiment in which defocused transmit-receive events are used in conjunction with three standard focused transmit-receive events. This method may provide a compromise on the resolution of the ultrasound image. In one embodiment, shown in FIG. 22, the method involves a separate transmission to each element of the render array and reception to separate receiving elements. After digitizing and storing data for each of the eight transmit-receive sequences, as shown in the timing diagram, synthetic aperture transmit and receive methods are used to achieve optimal ultrasound image resolution and provide the ideal beamwidth for evaluating transducer interaction for therapy. Synthetic aperture transmission and reception methods simultaneously apply transmission and reception delays to subsequently processed data for each spatial point in the ultrasound image. This method provides an ideal resolution of the entire ultrasound image in the case of a sufficient signal-to-noise ratio at reception by reducing the frame rate. The same method can be applied when probing the beam cross section for therapy.

Image Processing

[0189] In one embodiment, the advantage of using a defocused beam is to make it easier for the operator to evaluate the interaction and tissue behind the acoustic focus. In one embodiment, a method for displaying information includes calculating a spread in brightness at the top of an image. A large spread in dermal brightness clearly indicates insufficient interaction, while uniform brightness indicates uniform interaction of most of the therapy beam. The brightness spread calculation will be the second aspect of the patchy brightness at a certain depth, eg 1 mm to 2 mm from the acoustic window.

[0190] In one embodiment, a two-dimensional (2D) filtering function is used to reduce the brightness spread that occurs naturally due to the mottled pattern. In one embodiment, the user is presented with a quantitative, qualitative, and high-resolution image indicating the quality of the interaction in the acoustic window or tissue behind the focus.

[0191] In one embodiment, the interaction evaluation image is combined with a high resolution image. For example, two images can be multiplied with each other. This will allow a single image to be provided to the operator without having to remove any information from the high resolution image. With 2D multiplication (pixel by pixel), areas of poor interaction will be displayed as shading over the high resolution image. Then, based on the degree of luminance shading, the operator can decide whether the processing is appropriate. In one embodiment, the two images are blended together in an overlay that allows either the high resolution image or the interaction score image to stand out more. In one embodiment, the overlapping images may be configured such as images provided to radiologists when combining recorded images from different systems (eg, MRI and ultrasound).

Sequencing a Multi-Focus Zone

[0192] In various embodiments, ultrasound imaging is used with tissue therapeutic treatment. In various embodiments, one, two or more points and/or focal areas of therapeutic treatment are simultaneously created by the ultrasonic treatment system below the surface of the skin to effect a cosmetic treatment. In one embodiment, the treatment includes mechanical wobble, in which the therapy transducer is locally moved around the intended center of the thermal coagulation point (TCP). The acoustic beam can be moved transversely, up and down and/or at an angle. In one embodiment of the mechanical wobble, movement of the movement mechanism is fast enough to create a flatter temperature profile around the intended TCP, allowing either reduction of the total acoustic energy for the same volume of tissue being treated, or applying the same amount of total acoustic energy. energy for a larger volume of tissue being treated, or any combination thereof. In accordance with various embodiments, frequency modulation changes the location of the focal zone and/or the spacing between focal zones such that the electronic wobble of the beam, by frequency modulation, precisely changes and/or moves the position of the beam focus point(s). For example, in one embodiment, a 1.5 mm spacing can be wobbled at +/- 0.1 mm using a small frequency range. In various embodiments, any one or more intervals of 0.5, 0.75, 1.0, 1.2, 1.5, 2.0 mm can be wobbled with a value of +/- 0.01, 0.05, 0 .1, 0.12, 0.15, 0.20, 0.25, 0.30 mm using some frequency range. In various embodiments, the frequency is modulated by 1-200% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 100%, 120%, 150%, 180%, 200% and any range in between).

[0193] In various embodiments, multiple focal zones are used to improve ultrasound imaging in order to achieve better signal quality and resolution across depth. For conventional, conventional diagnostic ultrasound scanners (linear, non-linear, phased arrays, etc.), in which two-dimensional (2-D) ultrasound images are generated without the need for transducer movement, the order in which this set of focal zones is obtained is therefore not significant, since the precise placement of these focus areas can be controlled electronically. FIG. 23 illustrates imaging of a focal zone that is not moved during imaging, with an electronically controlled/translatable aperture. For non-movable imaging transducers, the positioning of the focal zone is precise, so focal zone sequencing is not used. In conventional multiple focal area imaging sequences, the order in which the focal area is probed is changed. For example, a 4-focal zone sequence will follow the sequence (f1, f2, f3, f4) regardless of location and direction of travel.

[0194] However, for moving imaging transducers (eg, mechanically translated or driven arrays), this will be problematic due to the positional differences of the transducer when it scans multiple focal areas. This positional misregistration is particularly exacerbated in bi-directional imaging (left-to-right and right-to-left imaging), because the probing area between the two images will be different. This principle is shown in FIG. 24 for the case of linear translation, but the present invention applies to all types of motion, including, without limitation, translational, rotary, and two-dimensional, or any combination thereof.

[0195] Embodiments of the imaging system described herein eliminate this inconsistency. FIG. 24 illustrates bidirectional imaging at the same lateral location. In specific cases, spatial misregistration is due to the transducer moving during imaging. In particular, as shown in the figure, the focal zones 4 (Fz4) are the furthest apart in the two images, although they should be probing the same area of interest. When forming a two-dimensional (2-D) image using a mechanically translated / controlled transducer, the transmit / receive position of the transducer will change due to the fact that during propagation associated with the ultrasonic signal, the transducer also moves.

[0196] In one embodiment, an alternative sequence is provided in which the first direction (outward) move sequence is to be performed in the normal order (f1, f2, f3, f4) and the second direction (return) move sequence is reversed ( f4, f3, f2, f1), allowing two images to be registered properly. In one embodiment, an alternative sequence is provided in which the move right (out) sequence is to be performed in normal order (f1, f2, f3, f4) and the move left (return) sequence is reversed (f4, f3, f2, f1 ), which allows the registration of two images properly (FIG. 25). In various embodiments, the direction may be left, right, forward, backward, up, or down.

[0197] FIG. 25 shows one embodiment of determining the sequence for the focal zone depending on the direction. The left move sequence is reversed from the right move sequence. This improved the alignment of the focal area. In addition, the data acquisition positions can be staggered so that the same areas of interest between the two images (FIG. 26) are properly registered.

[0198] FIG. 26 illustrates one embodiment of focus area sequencing versus direction with different trigger locations. Spatial registration between A-lines of movement to the right and movement to the left is further improved by staggering the actuation locations.

[0199] In one embodiment, the imaging system uses a new sequence of two consecutive A-lines with a continuous sequence (line 1: f1, f2, f3, f4; line 2: f4, f3, f2, f1). This sequence can be repeated over the entire field of view and, provided there is an even number of vectors in the field of view, the return sequence can include exactly the same interleaved focal zone sequence and these two images will be registered (FIG. 27).

[0200] FIG. 27 shows one embodiment of determining the sequence for the focal area depending on the direction, interleaved between (f1-f2-f3-f4) and (f4-f3-f2-f1) on successive A-lines. If the entire field of view is covered by an even number of A-lines, the left-moving and right-moving focus sequences are the same. The trigger locations still differ between the two images.

[0201] In various embodiments, the implementation of the multifocal area imaging provides the benefits of better correlation between images generated when moving in the first direction and moving in the second direction.

[0202] In various embodiments, multifocal area imaging provides the benefits of improved B-mode imaging performance at faster (eg, 2x, 3x, 4x) scan rates.

[0203] In various embodiments, multifocal area imaging is applied to any number of focal areas greater than one. In various embodiments, the number of focal zones is two, three, four, five, six, seven, eight, nine, ten, or more.

Converters

[0204] In various embodiments, transducer 280 includes a convex side 282 and a concave side 283. In various embodiments, transducer 280 includes a convex side 282 and a concave side 283 with features that provide any one or more of variable depth, variable spacing, variable position focus with one, two, three, four or more simultaneous focus areas. FIG. 28 shows one embodiment of a transducer 280 comprising a single element with a convex side 282 and a concave side 283. In FIG. 29 shows one embodiment of a transducer 280 comprising a solid coated convex side 282 and a striped concave side 283, the stripes comprising a first polarized and a second polarized region, the polarized region being positive, negative, or unpolarized. FIG. 29 shows one embodiment of a transducer 280 comprising a solid coated convex side 282 and a striped concave side 283, the stripes comprising first regions and second regions, the region may or may not be coated.

[0205] FIG. 30 illustrates one embodiment of a transducer 280 comprising a striped convex side 282 and a continuous coated concave side 283, the stripes comprising a first polarized and a second polarized region, the polarized region being positive, negative, or unpolarized. FIG. 30 shows one embodiment of a transducer 280 comprising a striped convex side 282 and a continuous coated concave side 283, the stripes comprising first regions and second regions, the region may or may not be coated.

[0206] FIG. 31 illustrates one embodiment of a transducer 280 comprising a striped convex side 282 and a striped concave side 283, the stripes comprising a first polarized and a second polarized region, the polarized region being positive, negative, or unpolarized, with the striped regions rotated from approximately 90 degrees apart from each other. FIG. 31 shows one embodiment of a transducer 280 comprising a striped convex side 282 and a continuous coated concave side 283, the stripes comprising first regions and second regions, the region may or may not be coated, and the stripes are rotated approximately 90 degrees. relative to each other.

[0207] FIG. 32 illustrates one embodiment of a transducer 280 comprising an annular convex side 282 and a striped concave side 283, the stripes comprising a first polarized and a second polarized region, the polarized region being positive, negative, or unpolarized. FIG. 32 shows one embodiment of a transducer 280 comprising an annular convex side 282 and a striped concave side 283, the stripes comprising first regions and second regions, the region may or may not be coated.

[0208] FIG. 33 illustrates one embodiment of a transducer 280 comprising a striped convex side 282 and an annular concave side 283, the stripes comprising a first polarized and a second polarized region, the polarized region being positive, negative, or unpolarized. FIG. 33 shows one embodiment of a transducer 280 comprising a striped convex side 282 and an annular coated concave side 283, the stripes comprising first regions and second regions, the region may or may not be coated. In some embodiments, the system comprises various features that are present as individual features (as opposed to multiple features). For example, in one embodiment, the system comprises, essentially consists of, or consists of a single ultrasonic transducer element that is configured to provide two simultaneous treatment zones via wobble. Many features or components are presented in alternative embodiments.

[0209] Certain embodiments and examples described herein are exemplary and are not intended to limit the description of the full scope of the compositions and methods of the present invention. Equivalent changes, modifications, and variations of certain embodiments, materials, compositions, and methods may be made within the scope of the present invention with substantially similar results.

[0210] Although the present invention is susceptible to various modifications and alternative forms, specific examples thereof are shown in the drawings and are described in detail herein. However, it should be understood that the present invention is not limited to the specific forms or methods disclosed, but rather, the present invention embraces all modifications, equivalents, and alternatives that are consistent with the spirit and that are within the scope of the various embodiments described and the appended claims. Any of the methods described herein need not be performed in the order listed. The methods disclosed herein include certain actions taken by the practitioner; however, they may also include any third-party instruction relating to these activities, whether express or implied. For example, actions such as "connecting the transducer module to the ultrasonic probe" include "instructing how to connect the transducer module to the ultrasonic probe." The ranges described herein also cover any and all overlaps, subranges, and combinations thereof. Expressions such as "up to", "at least", "more than", "less than", "between", etc. include the specified number. Numbers preceded by terms such as "about" or "approximately" include those numbers. For example, "about 25 mm" includes "25 mm".

Claims (80)

1. An ultrasound imaging system for cosmetic ultrasonic treatment of the skin, configured to reduce imaging mismatch, comprising: an ultrasound probe containing an ultrasound therapy transducer configured to apply ultrasound therapy to tissue, an ultrasound imaging transducer configured to image tissue, and a motion mechanism for moving the ultrasound imaging transducer in a first direction and a second direction, and a control module connected to the ultrasound probe to control the ultrasound imaging transducer, wherein the ultrasound imaging transducer is mechanically attached to the movement mechanism, wherein the first direction is opposite to the second direction, and the movement in the first direction is the reverse of the movement in the second direction, moreover, the transducer for ultrasound imaging is configured to form an image with the first order of the focal zones (f ₁ , ..., f _N ), where N > 1, when the transducer for ultrasonic imaging moves in the first direction, moreover, the transducer for ultrasound imaging is configured to form an image with the second order of focal zones (f _N ,…, f ₁ ) or (f ₁ ,…, f _N ) when the transducer for ultrasonic imaging moves in the second direction, moreover, when the second order of the focal zones is (f _N ,…, f ₁ ), then the second order of the focal zones is the inverse sequence of the first order of the focal zones (f ₁ ,…, f _N ), moreover, when the second order of the focal zones is (f ₁ ,…, f _N ), then the second order of the focal zones is the sequence of the first order of the focal zones (f ₁ ,…, f _N ), moreover, the spatial registration between the imaging A-lines in the first direction and the imaging A-lines in the second direction is improved by staggering the trigger locations for imaging in the first direction and imaging in the second direction, moreover, the ultrasound imaging system is configured to apply the sequence for the focal zone depending on the direction (f ₁ -...-f _N ) and (f ₁ -...-f _N ) or interleaving between (f ₁ -...-f _N ) and (f _N - ... -f ₁ ) on two successive A-lines. 2. An ultrasound imaging system for cosmetic ultrasonic treatment of the skin, configured to reduce imaging mismatch, comprising: an ultrasound probe containing an ultrasound therapy transducer configured to apply ultrasound therapy to tissue, an ultrasound imaging transducer configured to image tissue, and a motion mechanism for moving the ultrasound imaging transducer in a first direction and a second direction, and a control module connected to the ultrasound probe to control the ultrasound imaging transducer, wherein the ultrasound imaging transducer is mechanically attached to the movement mechanism, wherein the first direction is opposite to the second direction, and the movement in the first direction is the reverse of the movement in the second direction, moreover, the transducer for ultrasound imaging is configured to form an image with the first order of the focal zones (f ₁ , ..., f _N ), where N > 2, when the transducer for ultrasonic imaging moves in the first direction, moreover, the transducer for ultrasound imaging is configured to form an image with the second order of focal zones (f ₁ , ..., f _N ) when the transducer for ultrasonic imaging moves in the second direction, moreover, the second order of the focal zones (f ₁ ,…, f _N ) is the sequence of the first order of the focal zones (f ₁ ,…, f _N ), moreover, the spatial registration between the imaging A-lines in the first direction and the imaging A-lines in the second direction is improved by staggering the trigger locations for imaging in the first direction and imaging in the second direction, moreover, the ultrasound imaging system is configured to apply the sequence for the focal zone depending on the direction (f ₁ -...-f _N ) and (f ₁ -...-f _N ) on two successive A-lines. 3. An ultrasound imaging system for cosmetic ultrasonic treatment of the skin, configured to reduce imaging mismatch, comprising: an ultrasound probe containing an ultrasound therapy transducer configured to apply ultrasound therapy to tissue, an ultrasound imaging transducer configured to image tissue, and a motion mechanism for moving the ultrasound imaging transducer in a first direction and a second direction, a control module connected to the ultrasound probe to control the ultrasound imaging transducer, moreover, the ultrasound imaging transducer is mechanically attached to the movement mechanism, and the ultrasound imaging transducer and the ultrasound therapy transducer are configured as connected or coupled imaging/therapy transducers or as a combined dual-mode imaging/therapy transducer, wherein the first direction is opposite to the second direction, and the movement in the second direction is the reverse of the movement in the first direction, moreover, the spatial registration between the imaging A-lines in the first direction and the imaging A-lines in the second direction is improved by staggering the trigger locations for imaging in the first direction and imaging in the second direction, moreover, the transducer for ultrasound imaging is configured to form an image with the first order of the focal zones (f ₁ , ..., f _N ), where N > 1, when moving in the first direction, moreover, the transducer for ultrasound imaging is configured to form an image with a second order of focal zones (f ₁ , ..., f _N ) when moving in the second direction, while the second order of focal zones (f ₁ , ..., f _N ) is an equal sequence with respect to the first order of the focal zones (f ₁ ,…, f _N ), and moreover, the ultrasound imaging system is configured to apply the sequence for the focal zone depending on the direction (f ₁ - ... - f _N - f ₁ - ... - f _N ) on two successive A-lines. 4. An ultrasound imaging system for cosmetic ultrasonic treatment of the skin, configured to reduce imaging mismatch, comprising: ultrasonic probe, made with the possibility of placement on the surface of the skin and containing: hand probe and removable transducer module, moreover, the removable transducer module is made with the possibility of removable attachment to the manual probe, the removable transducer module contains a transducer for ultrasound therapy, the transducer for ultrasound therapy contains a piezoelectrically active material, the piezoelectrically active material has a focal length adapted to focus ultrasound therapy on tissue below the surface of the skin, wherein the tissue includes one or more of: dermis, hypodermis, superficial musculoaponeurotic system, and muscle, moreover, the transducer for ultrasound therapy is configured to focus ultrasound therapy at the point of thermal coagulation with acoustic energy with a processing frequency in the range selected from the group consisting of: 4 MHz, 7 MHz, 10 MHz, for thermal heating of tissue in order to provide coagulation for formation impact at the point of thermal coagulation, an ultrasound imaging transducer configured to visualize tissue, wherein the application of ultrasonic therapy is provided at the point of thermal coagulation to generate an impact based on precise matching of the tissue imaging obtained by the ultrasonic imaging transducer to improve the efficiency and safety of ultrasonic therapy on tissue including one or more of: dermis, hypodermis, superficial musculo-aponeurotic system and muscles; wherein the ultrasound therapy transducer and the ultrasound imaging transducer are coupled imaging/therapy transducers in the imaging and processing module; and a movement mechanism configured to move the coupled imaging/therapy transducers in the imaging and processing module in the first direction and the second direction to form thermal coagulation points on the tissue, while the thermal coagulation points form effects on the tissues with a processing interval, wherein the associated imaging/therapy transducers in the imaging and processing module are mechanically attached to the movement mechanism, wherein the first direction is linear, the second direction is linear, the first direction is parallel to the second direction, the first direction is opposite to the second direction, the ultrasonic imaging transducer is configured to form an image with the first order of focal zones (f ₁ ,…, f _N ) or (f _N ,…, f ₁ ), where N > 1, when moving in the first direction, the ultrasonic imaging transducer is configured to form an image with the second order of focal zones (f _N ,…, f ₁ ) or (f ₁ ,…, f _N ) when moving in the second direction, moreover, the spatial registration between the images of the transducer for ultrasound imaging with the first order of focal zones (f ₁ ,…, f _N ) or (f _N ,…, f ₁ ) in the first direction and the images of the transducer for ultrasound imaging with the second order of focal zones ( f _N ,…, f ₁ ) or (f ₁ ,…, f _N ) in the second direction is improved by staggering the actuation locations, while spatial registration improved by staggering trigger locations provides better correlation between ultrasound imaging transducer images with first order focal zones (f ₁ ,…, f _N ) or (f _N ,…, f ₁ ) in the first direction and transducer images for ultrasound imaging with the second order of focal zones (f _N ,…, f ₁ ) or (f ₁ ,…, f _N ) in the second direction, moreover, the staggered arrangement includes triggering to obtain an image at the trigger location for a period of time, moreover, the module for visualization and processing is configured to apply the sequence for the focal zone depending on the direction (f ₁ -...-f _N ) and (f ₁ -...-f _N ) or interleaving between (f ₁ -...-f _N ) and (f _N - ... -f ₁ ) on successive A-lines; and a control module connected to the ultrasound probe and configured to control the ultrasound therapy transducer for tissue treatment and the ultrasound imaging transducer for tissue imaging. 5. An ultrasound imaging system for cosmetic ultrasonic treatment of the skin, configured to reduce imaging mismatch, comprising: an ultrasound probe comprising an ultrasound imaging transducer capable of imaging tissue and a movement mechanism for moving the ultrasound imaging transducer in a first direction and a second direction, and a control module connected to the ultrasound probe to control the ultrasound imaging transducer, wherein the ultrasound imaging transducer is mechanically attached to the movement mechanism, wherein the first direction is opposite to the second direction, and the movement in the first direction is the reverse of the movement in the second direction, moreover, the transducer for ultrasound imaging is configured to form an image with the first order of the focal zones (f ₁ , ..., f _N ), where N > 2, when the transducer for ultrasonic imaging moves in the first direction, moreover, the transducer for ultrasound imaging is configured to form an image with the second order of focal zones (f ₁ , ..., f _N ) when the transducer for ultrasonic imaging moves in the second direction, moreover, the second order of the focal zones (f ₁ ,…, f _N ) is the sequence of the first order of the focal zones (f ₁ ,…, f _N ), moreover, the spatial registration between the imaging A-lines in the first direction and the imaging A-lines in the second direction is improved by staggering the trigger locations for imaging in the first direction and imaging in the second direction, moreover, the ultrasound imaging system is configured to apply the sequence for the focal zone depending on the direction (f ₁ -...-f _N ) and (f ₁ -...-f _N ) on two successive A-lines. 6. An ultrasound imaging system according to any one of paragraphs. 1-5, wherein the ultrasound therapy transducer is configured to treat tissue in a first set of sites that are located in a first zone and a second set of sites that are located in a second zone, the first zone being different from the second zone. 7. An ultrasound imaging system according to any one of paragraphs. 1-5, in which the ultrasound therapy transducer is configured to apply ultrasound therapy using amplitude modulation, while parts of the ultrasound therapy transducer are configured to provide ultrasound therapy with acoustic intensity amplitudes, the first amplitude being different from the second amplitude. 8. An ultrasound imaging system according to any one of paragraphs. 1-5, in which at least one part of the ultrasound therapy transducer is configured to provide ultrasound therapy with two or more amplitudes of acoustic intensity, and the amplitude of the ultrasound therapy provided by at least one part of the ultrasound therapy transducer changes over time. 9. An ultrasound imaging system according to any one of paragraphs. 1-5, wherein the ultrasound therapy transducer comprises a piezoelectric material, and parts of the ultrasound therapy transducer are configured to create appropriate changes in the piezoelectric material in response to an electric field applied to the ultrasound therapy transducer. 10. The ultrasound imaging system of claim 9, wherein the respective changes in the piezoelectric material include at least one of expansion of the piezoelectric material and contraction of the piezoelectric material. 11. An ultrasound imaging system according to any one of paragraphs. 1-5, in which the ultrasound therapy transducer is configured to apply ultrasound therapy by phase shift, while parts of the ultrasound therapy transducer are configured to provide ultrasound therapy with phases of acoustic intensity, and the first phase is different from the second phase, while the acoustic phase intensities include discrete phase values. 12. An ultrasound imaging system according to any one of paragraphs. 1-5, in which the ultrasound therapy transducer is configured to apply ultrasound therapy by polarization, and the ultrasound therapy transducer contains parts, wherein the first part of the ultrasound therapy transducer is polarized using a first polarization configuration, and the second part of the ultrasound therapy transducer is polarized using the second polarization configuration. 13. An ultrasound imaging system according to any one of paragraphs. 1-5, wherein the ultrasound therapy transducer is configured to: applying ultrasound therapy using amplitude modulation, wherein the ultrasound therapy transducer parts are configured to provide ultrasound therapy with acoustic intensity amplitudes, the first amplitude being different from the second amplitude; and an ultrasound therapy application in which the first part of the ultrasound therapy transducer is polarized using the first polarization configuration and the second part of the ultrasound therapy transducer is polarized using the second polarization configuration. 14. An ultrasound imaging system according to any one of paragraphs. 1-5, wherein the ultrasound therapy is at least one of: face skin tightening, brow lift, chin lift, eye treatment, wrinkle reduction, decollete skin enhancement, buttock lift, scar reduction, burn treatment, skin firming, blood vessel reduction, sweat gland treatment, freckle removal, fat treatment, cellulite treatment, vaginal rejuvenation and acne treatment. 15. An ultrasound imaging system according to any one of paragraphs. 1-5, in which the ultrasonic therapy is the treatment of abdominal laxity. 16. An ultrasound imaging system according to any one of paragraphs. 1-5, in which the transducer for ultrasound imaging is configured to form an image with a first order of focal zones, indicated as (f ₁ , ..., f _N ), where N > 2. 17. An ultrasound imaging system according to any one of paragraphs. 1-5, in which N = any value from the group consisting of: 2, 3, 4, 5, 6, 7, 8, 9 and 10.

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