HK1233204B - Band transducer ultrasound therapy - Google Patents

Description

Ultrasound therapy with a ribbon transducer

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. Provisional Application No. 61/981,660, filed April 18, 2014, the entire contents of which are incorporated herein by reference.

Technical Field

Several embodiments of the present invention are generally directed to non-invasive, semi-invasive, and/or invasive energy-based treatments that achieve cosmetic and/or medical effects. For example, some embodiments are generally directed to devices, systems, and methods having linear, curved, planar, and/or three-dimensional ultrasound therapeutic focal zones for safely and effectively performing various therapeutic procedures. Different embodiments of the therapeutic system can improve cosmetic effects and patient outcomes by reducing treatment time and/or lowering treatment energy, which can improve comfort and cosmetic effects. In various embodiments, the ultrasound transducer has a therapeutic focal zone in the form of one or more lines, strips, bands, and/or planes.

Background Art

Many cosmetic procedures involve invasive procedures that may require invasive surgery, which may place greater demands on biocompatibility and sterility. Not only must patients endure weeks of recovery time, but they are also often required to undergo dangerous anesthesia procedures to undergo cosmetic treatments. Traditional cosmetic procedures that involve piercing or cutting the skin surface to access target tissue beneath the skin surface often involve higher demands on biocompatibility and sterility. Certain traditional energy-based treatments, such as those utilizing radiofrequency (RF) and laser treatments, must heat or treat tissue starting from the skin surface, which affects all intermediate tissues between the skin surface and the target tissue at a certain depth beneath the skin surface.

Summary of the Invention

Although energy-based treatments for cosmetic and medical purposes have been disclosed, applicants are not aware of any procedures other than applicants' own work that successfully achieve aesthetic tissue heating and/or therapeutic effects by expanding the area and volume of tissue treated in a specific target area using band-shaped therapeutic focal zone technology, utilizing targeted and precise ultrasound waves to provide visible and effective cosmetic effects via thermal pathways. Treatment can include heating, coagulation, and/or ablation (including, for example, hyperthermia, thermal dosimetry, apoptosis, and cytolysis). In various embodiments, band treatment provides improved thermal heating and treatment of tissue compared to diathermy or general bulk heating techniques. In various embodiments, band treatment provides the ability to heat and/or treat tissue at a specific depth range without affecting adjacent tissue. Generally speaking, diathermy and bulk heating techniques typically involve heating the skin surface and conducting heat through the skin surface and all underlying tissues so that heat reaches tissue at a target depth below the skin surface. In various embodiments, band treatment provides targeted heating and treatment at a specific, prescribed depth range below the skin surface without heating the skin surface and/or intermediate tissue between the skin surface and the target tissue. This deflected band therapy reduces trauma to the skin surface and associated pain, and treats tissue only at a defined, targeted tissue depth. Thus, embodiments of the present invention can be used to treat tissue within a specific depth range below the skin surface without heating the skin surface. In some embodiments, band therapy can also be used to prepare tissue at the target depth for a secondary ultrasound treatment by preheating the target tissue to an elevated temperature, thereby enabling a secondary treatment to be performed with reduced time and/or energy and increased comfort.

According to various embodiments, cosmetic ultrasound therapy systems and/or methods can non-invasively generate single or multiple cosmetic treatment zones and/or thermal treatment points, lines, bands, strips, planes, areas, volumes, and/or shapes, wherein ultrasound waves are focused at one or more locations within the treatment zone within tissue at one or more depths below the skin surface. Some systems and methods provide cosmetic treatment at different locations within tissue, wherein the treatment zones are at various depths, heights, widths, and/or positions. In one embodiment, the methods and systems include a transducer system configured to provide ultrasound treatment to more than one region of interest, such as between at least two treatment locations and/or regions of interest. In one embodiment, the methods and systems include a transducer system configured to provide ultrasound treatment to more than one region of interest, such as between at least two lines at different locations (e.g., at a fixed or variable depth, height, width, direction, etc.) within the region of interest within tissue. In various embodiments, the lines can be straight, curved, continuous, and/or non-continuous. In some embodiments, the energy beam is split to focus at two, three, four or more focal zones (e.g., multiple focal lines, multifocal lines) for the cosmetic treatment area and/or for imaging in a region of interest in the tissue. The location of the focal zone can be positioned axially, laterally or otherwise within the tissue. Some embodiments can be configured for spatial control, such as by positioning the focal lines, changing the distance or angle between the transducer and the optional motion mechanism, and/or changing the angle of energy that is focused or not focused on the region of interest, and/or configured for temporal control, such as by controlling changes in the frequency, drive amplitude and timing of the transducer. In some embodiments, the location of multiple treatment zones can be achieved by polarization, phase polarization, biphasic polarization and/or multiphase polarization. As a result, the location of the treatment zone, the number, shape, size and/or volume of the treatment zone in the region of interest, the heated zone and/or the lesion, and the thermal conditions can be dynamically controlled over time. Additional details regarding polarization and alignment are disclosed in U.S. patent application Ser. No. 14/193,234, filed Feb. 28, 2014, and having U.S. Publication No. 2014-0257145, which is incorporated herein by reference in its entirety.

In one embodiment, an aesthetic imaging and treatment system includes a handheld probe having a housing enclosing an ultrasound transducer configured to apply ultrasound therapy to tissue in a focal zone. In one embodiment, the focal zone is a line. In one embodiment, the focal zone is a two-dimensional area or a plane. In one embodiment, the focal zone is a volume. In various embodiments, the treatment area for focal zone therapy is linear, curved, rectangular, and/or planar. In various embodiments, the size of the treatment area depends on the size of the transducer. Treatment can be performed within a line and/or a plane. In various embodiments, the width of the treatment focal zone is 5-50 mm, 5-30 mm, 5-25 mm, 10-25 mm, 10 mm-15 mm, 15 mm-20 mm, 10 mm, 15 mm, 20 mm, 25 mm, or any range thereof (including, but not limited to, 12 mm-22 mm). In various embodiments, the focal zone can be moved to sweep a volume between a first position and a second position. In various embodiments, one or more focal zone positions can be located in a substantially linear sequence within the aesthetic treatment volume. In various embodiments, one or more focal zone locations are positioned using one, two, or more motion mechanisms to form any shape of treatment area within the cosmetic treatment zone. In one embodiment, a first set of locations is located within a first cosmetic treatment zone and a second set of locations is located within a second cosmetic treatment zone, the first zone being different from the second zone. In one embodiment, the first cosmetic treatment zone comprises a substantially linear sequence of the first set of locations and the second cosmetic treatment zone comprises a substantially linear sequence of the second set of locations. In some non-limiting embodiments, the transducer can be configured for a treatment zone at a tissue depth of 1.5 mm, 3 mm, 4.5 mm, 6 mm, less than 3 mm, between 1.5 mm and 3 mm, between 1.5 mm and 4.5 mm, greater than 4.5 mm, greater than 6 mm, and anywhere in the range of 0.1 mm-3 mm, 0.1 mm-4.5 mm, 3 mm-7 mm, 3 mm-9 mm, 0.1 mm-25 mm, 0.1 mm-100 mm, and any depth therein, including, for example, 4.5 mm-6 mm, 1 mm-20 mm, 1 mm-15 mm, 1 mm-10 mm, 5 mm-25 mm, and any depth therein, below the skin surface. In one embodiment, the cosmetic treatment zone is continuous. In one embodiment, the cosmetic treatment zone has no gaps. In one embodiment, a series of individual cosmetic treatment areas have treatment intervals ranging from about 0.05 mm to about 25 mm (e.g., 0.05-0.1 mm, 0.05-1 mm, 0.2-0.5 mm, 0.5-2 mm, 1-10 mm, 0.5-3 mm, 5-12 mm). In various embodiments, the treatment intervals have constant spacing, variable spacing, overlapping spacing, and/or non-overlapping spacing.

In one embodiment, the ultrasonic transducer is configured to provide a therapeutic intensity in the range of about 1 W/ ^cm2 to 100 W/ ^cm2 on the transducer surface (e.g., 1-50, 10-90, 25-75, 10-40, 50-80 W/ ^cm2 and any ranges and values therein). In one embodiment, the ultrasonic transducer is configured to provide an acoustic power for ultrasonic therapy in the range of about 1 W to about 100 W and a frequency of about 1 MHz to about 10 MHz to thermally heat the tissue. In a different embodiment, the transducer module is configured to provide an acoustic power for ultrasonic therapy in the range of about 1 W to about 100 W (e.g., 5-40 W, 10-50 W, 25-35 W, 35-60 W, 35 W, 40 W, 50 W, 60 W) and a frequency of about 1 MHz to about 10 MHz to thermally heat the tissue. In one embodiment, the acoustic power can range from 1 W to about 100 W, and the frequency range is from about 1 MHz to about 12 MHz (e.g., 3.5 MHz, 4 MHz, 4.5 MHz, 7 MHz, 10 MHz, 3-5 MHz), or the acoustic power can range from about 10 W to about 50 W, and the frequency range is from about 3 MHz to about 8 MHz. In one embodiment, the acoustic power and frequency are about 40 W and about 4.3 MHz, and about 30 W and about 7.5 MHz. In different embodiments, the transducer module is configured to deliver energy without spacing or with a spacing of 0.1-2 mm (e.g., 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.5 mm). In different embodiments, the spacing is constant or variable. In various embodiments, the transducer module is configured to deliver energy with an on time of 10-500 ms (e.g., 30-100, 90-200, 32, 35, 40, 50, 60, 64, 75, 90, 100, 112, 200, 300, 400 ms, and any ranges therein). In various embodiments, the transducer module is configured to deliver energy with an off time of 1-200 ms (e.g., 4, 10, 22, 45, 60, 90, 100, 150 ms, and any ranges therein). In one embodiment, the acoustic energy generated by the acoustic power can be between about 0.01 joules ("J") and about 10 J or between about 2 J and about 5 J. In one embodiment, the acoustic energy is in the range of less than about 3 J. In various embodiments, the acoustic energy generated by the acoustic power in a single dose pass can be between about 1 and 500 J (e.g., 20-310, 70, 100, 120, 140, 150, 160, 200, 250, 300, 350, 400, 450 J and any range therein). In various embodiments, treatment can involve 1, 2, 3, 4, 5, 10 or more dose passes.

In several embodiments disclosed herein, non-invasive ultrasound is used to achieve one or more of the following effects: tissue heating, tissue preheating, facial wrinkle removal, brow lift, chin lift, eye treatment, wrinkle removal, scar removal, burn treatment, tattoo removal, vein removal, vein reduction, treatment of sweat glands, treatment of hyperhidrosis, weight loss or fat reduction and/or cellulite reduction, sun spot removal, acne treatment, papule reduction. In several embodiments, treatment of skin wrinkles is provided. In another embodiment, the system, device and/or method can be applied to the genital area (e.g., vaginal rejuvenation and/or vaginal tightening, such as for tightening the supporting tissues of the vagina). In several embodiments described herein, the process is entirely cosmetic, rather than medical. For example, in one embodiment, the method described herein does not have to be performed by a doctor, but is performed in a spa or other aesthetic institution. In some embodiments, the system can be used for non-invasive cosmetic treatment of the skin.

In one embodiment, a method of reducing focal gain variation of a cylindrical ultrasonic transducer comprises providing a cylindrical transducer element comprising a convex surface and a concave surface, wherein one of the surfaces (e.g., the concave surface) comprises a plurality of electrodes (or, for example, an electrical conductor or electrical material), the method further comprising subsequently applying a current to the electrodes, thereby directing ultrasonic energy to a linear focal region at a focal depth. The ultrasonic energy produces a reduced focal gain variation in the linear focal region. The concave surface may be silver-plated. The convex surface may comprise an uncoated region and a plurality of coated regions. The plurality of coated regions may comprise fired silver to form a plurality of electrodes. Features on the convex surface may be instead on the concave surface.

In one embodiment, the reduction of edge noise facilitates effective and consistent treatment of tissue, wherein a cylindrical transducer element is configured to apply ultrasound treatment to a linear tissue thermal treatment zone at the depth of the focal point.

In one embodiment, the reduction of edge noise facilitates efficient and consistent heating of a material, wherein the material is any one of the group consisting of a compound, an adhesive, and a food.

In one embodiment, an ultrasonic transducer system for reducing edge noise at a focal line includes a cylindrical transducer element and a power supply configured to drive the cylindrical transducer element. The cylindrical transducer element is configured to apply ultrasonic energy to a linear focal zone at a focal depth. The cylindrical transducer element includes a convex surface and a concave surface. The concave surface is plated with an electrical conductor, such as silver. The convex surface includes an uncoated region and one or more coated regions, wherein the one or more coated regions include silver to form electrodes. The power supply is in electrical communication with the electrodes. The coated regions are configured to reduce focal gain differences at the linear focal zone at the focal depth.

In one embodiment, an ultrasonic transducer system for reducing edge noise at a focal line includes a cylindrical transducer element and a power supply configured to drive the cylindrical transducer element. The cylindrical transducer element is configured to apply ultrasonic energy to a linear focal zone at a focal depth. The cylindrical transducer element includes a convex surface and a concave surface. The convex surface is silver-plated. The concave surface includes an uncoated region and one or more coated regions, wherein the one or more coated regions include silver to form electrodes. The power supply is in electrical communication with the electrodes. The coated regions are configured to reduce focal gain differences at the linear focal zone at the focal depth.

In one embodiment, a coated transducer for reducing focal gain variation at a focal region includes a cylindrical transducer element comprising a convex surface and a concave surface. The concave surface is silver-coated. The convex surface includes an uncoated region and a plurality of coated regions. The plurality of coated regions include silver forming a plurality of electrodes. The cylindrical transducer element is configured to apply ultrasound therapy to a linear focal region at a focal depth. The coated region is configured to reduce focal gain variation at the linear focal region.

In one embodiment, a coated transducer for reducing focal gain variation at a focal region includes a cylindrical transducer element comprising a convex surface and a concave surface. In one embodiment, the convex surface is electroplated. In one embodiment, the concave surface is electroplated. In one embodiment, the concave surface includes an uncoated region and a plurality of coated regions. In one embodiment, the convex surface includes an uncoated region and a plurality of coated regions. The plurality of coated regions include conductors forming a plurality of electrodes. The cylindrical transducer element is configured to apply ultrasound therapy to a linear focal region at a focal depth. The coated region is configured to reduce focal gain variation at the linear focal region.

In one embodiment, an aesthetic treatment system includes a cylindrical transducer element comprising a convex surface and a concave surface. In one embodiment, the concave surface is plated with silver to form an electrode. In one embodiment, the convex surface is plated with silver to form an electrode. In one embodiment, the convex surface includes an uncoated region and one or more coated regions, wherein the one or more coated regions include silver to form an electrode. In one embodiment, the concave surface includes an uncoated region and one or more coated regions, wherein the one or more coated regions include silver to form an electrode. The cylindrical transducer element is configured to apply ultrasound therapy to a linear tissue thermal treatment zone at a focal depth. The coated region is configured to reduce focal gain differences at the thermal treatment zone. The cylindrical transducer element is housed within an ultrasound handheld probe. In one embodiment, the ultrasound probe includes a housing, a cylindrical transducer element, and a motion mechanism. The ultrasound transducer is movable within the housing. The motion mechanism is attached to the ultrasound transducer and configured to move the ultrasound transducer along a linear path within the housing.

In one embodiment, an aesthetic imaging and treatment system includes an ultrasound probe comprising a housing, a coated ultrasound transducer, and a motion mechanism. The ultrasound transducer is movable within the housing and includes a cylindrical transducer element and an imaging element. The cylindrical transducer element is configured to apply ultrasound therapy to a linear tissue thermal treatment zone at a focal depth. The cylindrical transducer element has an opening configured to accommodate the imaging element. The cylindrical transducer element includes a convex surface and a concave surface. In one embodiment, the entire concave surface is coated with silver. In one embodiment, the entire convex surface is coated with silver. In one embodiment, the convex surface includes an uncoated portion and one or more coated regions. In one embodiment, the concave surface includes an uncoated portion and one or more coated regions. The coated regions include silver to form electrodes. The coated regions are configured to reduce focal gain differences at the thermal treatment zone. The motion mechanism is attached to the ultrasound transducer and configured to move the ultrasound transducer along a linear path within the housing.

As provided herein, one of the surfaces of the transducer element (the convex surface or the concave surface) is completely covered (or at least 90% covered) with a conductive material (including, but not limited to, silver or another metal or alloy), and the other surface (the convex surface or the concave surface) has multiple regions (or patterns or patches) of coated and uncoated portions that are coated with a conductive material (including, but not limited to, silver or another metal or alloy). This can be advantageous in several embodiments because it facilitates uniform heating (e.g., reducing temperature spikes or fluctuations). In some embodiments, both surfaces (the convex surface and the concave surface) include multiple regions (or patterns or patches) of coated and uncoated portions. While convex and concave surfaces are described herein, in some embodiments, one or both of these surfaces can be planar. Furthermore, the convex or concave surfaces described herein can be multi-faceted (e.g., having multiple convex and/or concave surfaces) and also include surfaces having curvature (e.g., one or more angles less than 180 degrees). In several embodiments, the pattern of coated and uncoated areas can include one, two, or more coated areas and one, two, or more uncoated areas, wherein the coated areas cover at least 60%, 70%, 80%, or 90% of the surface. Additionally, the uncoated areas can be considered uncoated to the extent that they lack a conductive coating—in certain embodiments, the uncoated areas can have other types of surface coatings.

In various embodiments, the ultrasound system includes a transducer having a transducer element (e.g., a flat, spherical, circular, cylindrical, annular, a transducer element having a ring, concave, convex, contoured, or other shape).

In various embodiments, an ultrasound transducer system includes a transducer element (e.g., a cylindrical transducer element) and a power source configured to drive the transducer element, wherein the transducer element is configured to apply ultrasonic energy to a linear focal zone at a focal depth, wherein the transducer element includes a first surface and a second surface, wherein the first surface includes a conductive coating, wherein the second surface includes at least one conductive coated region and at least one uncoated region not coated with the conductive coating, wherein the at least one coated region on the second surface includes a conductive material that forms an electrode when the power source is in electrical communication with the at least one coated region, wherein the at least one coated region on the second surface is configured to reduce edge noise at the linear focal zone at the focal depth.

In various embodiments, an ultrasound transducer system includes a cylindrical transducer element and a power source configured to drive the cylindrical transducer element, wherein the cylindrical transducer element is configured to apply ultrasound energy to a linear focal zone at a focal depth. In some embodiments, the cylindrical transducer element includes a first surface and a second surface, wherein the first surface includes a coating, wherein the second surface includes at least one coated region and at least one uncoated region, wherein the at least one coated region on the second surface includes a conductive material that forms an electrode when the power source is in electrical communication with the at least one coated region, wherein the at least one coated region on the second surface is configured to reduce edge noise at the linear focal zone at the focal depth.

In one embodiment, the uncoated area does not include a conductive material. In one embodiment, the conductive material is a metal (e.g., silver, gold, platinum, mercury, and/or copper, or an alloy). In one embodiment, the first surface is a concave surface and the second surface is a convex surface. In one embodiment, the first surface is a convex surface and the second surface is a concave surface. In one embodiment, the cylindrical transducer element is housed within an ultrasound handheld probe, wherein the ultrasound probe comprises a housing, the cylindrical transducer element, and a motion mechanism, wherein the ultrasound transducer is movable within the housing, wherein the motion mechanism is attached to the ultrasound transducer and configured to move the ultrasound transducer along a linear path within the housing. In one embodiment, the motion mechanism automatically moves the cylindrical transducer element to heat the treatment area at the focal depth to a temperature within a range between 40-65 degrees Celsius (e.g., 40-45, 40-50, 40-55, 45-60, 45-55, 45-50 degrees Celsius, and any value therein). In one embodiment, the reduction in edge noise facilitates generating a uniform (e.g., completely uniform, substantially uniform, approximately approximately uniform) temperature in a treatment region. In one embodiment, the reduction in edge noise facilitates efficient and consistent treatment of tissue, wherein a cylindrical transducer element is configured to apply ultrasound therapy to a treatment region at a focal depth in the tissue. In one embodiment, the reduction in edge noise reduces peak intensity, thereby reducing variations around the focal depth by 75-200% (e.g., 75-100, 80-150, 100-150, 95-175%, and any values therein). In one embodiment, the reduction in edge noise reduces peak intensity, thereby reducing variations around the focal depth by 5 mm or less (e.g., 4.5, 4, 3.5, 3, 2.5, 2, 1.5, 1, 0.5, or less). In one embodiment, the reduction in edge noise reduces focal gain variation to within a range of 0.01-10 (e.g., 1-5, 2-8, 0.5-3, and any values therein). In one embodiment, the power supply is configured to drive the cylindrical transducer element to produce a temperature in the range of 42-55 degrees Celsius (e.g., 43-48, 45-53, 45-50 degrees Celsius, and any values therein) in the tissue at the focal depth. In one embodiment, a temperature sensor is located on the housing adjacent to an acoustic window in the housing, configured to measure the temperature at the skin surface. In one embodiment, the system includes one or more imaging elements, wherein the cylindrical transducer element has an opening configured for placement of the one or more imaging elements. In one embodiment, the imaging element is configured to confirm the level of acoustic coupling between the system and the skin surface. In one embodiment, the imaging element is configured to confirm the level of acoustic coupling between the system and the skin surface by any one of the group consisting of: defocus imaging and voltage standing wave ratio (VSWR). In one embodiment, the imaging element is configured to measure the temperature at the target tissue at the focal depth below the skin surface. In one embodiment, the imaging element is configured to measure the temperature at the target tissue at the focal depth below the skin surface using any one of the group consisting of acoustic radiation force impulse (ARFI), shear wave elastography (SWEI), and attenuation measurement.

In several embodiments, a method for heating tissue with a cylindrical ultrasonic transducer includes providing a cylindrical transducer element comprising a first surface, a second surface, a coated region, and an uncoated region. In some embodiments, the coated region comprises an electrical conductor. In some embodiments, the uncoated region does not comprise an electrical conductor. In some embodiments, the first surface comprises at least one coated region, wherein the second surface comprises an uncoated region and a plurality of coated regions, and applying an electrical current to the coated region to direct ultrasonic energy into a linear focal zone at a focal depth, wherein the ultrasonic energy produces a reduction in focal gain in the linear focal zone.

In several embodiments, the cosmetic method utilizes a heating source (e.g., a cylindrical ultrasonic transducer) to non-invasively and non-ablatively heat tissue to heat an area under the patient's skin by 5-25 degrees Celsius, while maintaining the same temperature at the skin surface or increasing it to a temperature that does not cause discomfort (e.g., an increase of 1-5, 1-10, 1-15 degrees Celsius). This difference is beneficial to the patient's comfort. In one embodiment, heating is performed in an incremental manner over a period of 5-120 minutes, with the temperature increasing stepwise or gradually. Heating can be performed by the cylindrical ultrasonic transducer system described herein. Optionally, ablative or coagulation energy can be applied subsequently by increasing the temperature by another 5-25 degrees Celsius. An initial preheating step or overall heating is advantageous because it allows less energy to be applied to obtain a coagulated/ablated state. In one embodiment, the initial preheating step is performed with a heating source different from the ultrasonic transducer. For example, instead of or in addition to ultrasound, radio frequency, microwave, light, convection, conversion and/or conductive heat sources can be used.

In several embodiments, a non-invasive cosmetic method for heating tissue includes applying a cosmetic heating system to a skin surface, wherein the cosmetic heating system includes a handheld probe. In some embodiments, the handheld probe includes a housing enclosing an ultrasonic transducer, the ultrasonic transducer configured to heat tissue beneath the skin surface to a tissue temperature in the range of 40-50 degrees Celsius (e.g., 44-47, 41-49, 45-50 degrees Celsius, and any values therein). In some embodiments, the ultrasonic transducer includes a cylindrical transducing element including a first surface, a second surface, a coated region, and an uncoated region, wherein the coated region includes an electrical conductor, wherein the first surface includes at least one coated region, and wherein the second surface includes an uncoated region and a plurality of coated regions. In some embodiments, the method includes applying an electrical current to the plurality of coated regions to direct ultrasound energy into a linear focal zone at a focal depth, wherein the ultrasound energy produces a reduction in focal gain in the linear focal zone to heat tissue at the focal depth in the linear focal zone to a tissue temperature in the range of 40-50 degrees Celsius for a cosmetic treatment duration of less than 1 hour (e.g., 1-55, 10-30, 5-45, 15-35, 20-40 minutes and any values therein) to reduce the volume of adipose tissue in the tissue.

In one embodiment, the reduction in focal gain facilitates effective and consistent treatment of tissue, wherein the cylindrical transducer element is configured to apply ultrasound therapy to a thermal treatment zone at the focal depth. In one embodiment, the reduction in focal gain reduces the peak value such that the variation around the focal depth is reduced by 25-100% (e.g., 30-50, 45-75, 50-90%, and any values therein). In one embodiment, the reduction in focal gain reduces the peak value such that the variation in intensity around the focal depth is 5 mm or less (e.g., 1, 2, 3, 4 mm or less). In one embodiment, the reduction in focal gain reduces the variation in focal gain to within a range of 0.01-10 (e.g., 0.06, 3, 4.5, 8, or any value therein). In one embodiment, the electrical conductor is a metal. In one embodiment, the first surface is a concave surface and the second surface is a convex surface. In one embodiment, the first surface is a convex surface and the second surface is a concave surface. In one embodiment, a cylindrical transducer element is housed within an ultrasound handheld probe, wherein the ultrasound probe comprises a housing, a cylindrical transducer element, and a motion mechanism, wherein the ultrasound transducer is movable within the housing, wherein the motion mechanism is attached to the ultrasound transducer and configured to move the ultrasound transducer along a linear path within the housing. In one embodiment, the motion mechanism automatically moves the cylindrical transducer element to heat a treatment area at a focal depth to a temperature within a range of 40-65 degrees Celsius. In one embodiment, the cylindrical transducer element produces a temperature within a range of 42-55 degrees Celsius in tissue at the focal depth. In one embodiment, the method further comprises imaging the tissue with one or more imaging elements, wherein the cylindrical transducer element has an opening configured for placement of the one or more imaging elements. In one embodiment, the method further comprises confirming a level of acoustic coupling between the system and the skin surface using an image from the imaging element. In one embodiment, the method further comprises confirming the level of acoustic coupling between the system and the skin surface using the imaging element, wherein the imaging element uses any one of the following: defocused imaging and voltage standing wave ratio (VSWR). In one embodiment, the method further comprises measuring the temperature of the target tissue at a focal depth below the surface of the skin using an imaging element. In one embodiment, the method further comprises measuring the temperature of the target tissue at a focal depth below the surface of the skin using an imaging element utilizing any one of the group consisting of acoustic radiation force impulse (ARFI), shear wave elastography (SWEI), and attenuation measurement.

The methods summarized above and set forth in further detail below describe certain actions taken by a practitioner; however, it should be understood that they may also include instructions for those actions issued by another group of people. Thus, an action such as "applying ultrasonic energy" includes "instructing the application of ultrasonic energy."

Furthermore, further areas of applicability will become apparent from the description provided herein.It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the embodiments disclosed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

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 be more fully understood based on the detailed description and accompanying drawings, in which:

FIG1 is a schematic diagram of an ultrasound system according to various embodiments of the present invention.

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

FIG3 shows a schematic side cross-sectional view of a cylindrical transducer in a cosmetic treatment system according to one embodiment. Although a cylindrical transducer is shown here, the transducer need not be cylindrical. In several embodiments, the transducer has one or more shapes or configurations that cause edge effects, such as differences, spikes, or other inconsistencies in the transmission of ultrasound waves. For example, the transducer may have one or more nonlinear (e.g., curved) portions.

FIG. 4 shows a schematic isometric side view of the cut-away cylindrical transducer of FIG. 3 .

5A-5B illustrate schematic isometric side views of a cylindrical transducer moved by a motion mechanism in a cosmetic treatment system according to an embodiment, wherein a thermal treatment zone (TTZ) is swept across the treatment area.

6 shows a schematic exploded isometric view of a cylindrical transducer element in a cosmetic treatment system according to an embodiment.

7 shows a schematic isometric view of the cylindrical transducer element of FIG. 6 with a motion mechanism in a cosmetic treatment system according to an embodiment.

8 shows a schematic isometric view of a cylindrical transducer element with the motion mechanism of FIG. 7 in a probe housing of a cosmetic treatment system according to an embodiment.

9 is a schematic partial cross-sectional view of a portion of a transducer according to various embodiments of the present invention.

10 is a partial side cross-sectional view of an ultrasound system according to various embodiments of the present invention.

11A-11B are a schematic diagram and a graph illustrating a standard pressure distribution at a depth of 20 mm according to an embodiment of a transducer including a cylindrical transducing element.

12A-12B are a schematic diagram and a graph illustrating a standard pressure distribution at a depth of 15 mm for an embodiment of a transducer including a cylindrical transducing element according to FIGs. 11A-11B .

13A-13B are a schematic diagram and a graph illustrating a standard pressure distribution at a depth of 13 mm for an embodiment of a transducer including a cylindrical transducing element according to FIGs. 11A-11B .

14A-14B are schematic graphs illustrating standard pressure distribution at a depth of 20 mm according to an embodiment of a transducer including cylindrical transducing elements.

15A-15B are schematic diagrams illustrating standard pressure distribution at a depth of 15 mm for an embodiment of a transducer including cylindrical transducing elements according to FIGs. 11A-11B .

16A-16B are schematic diagrams illustrating a standard pressure distribution at a depth of 13 mm for an embodiment of a transducer including cylindrical transducing elements according to FIGs. 11A-11B .

17 is a graph illustrating the temperature of pig muscle over time at various power levels for an embodiment of a transducer including cylindrical transducing elements.

18 is a photograph of porcine muscle after experimental treatment demonstrating confirmed lines and planes of heating using an embodiment of a transducer comprising cylindrical transducing elements.

19 is a cross-section through the porcine muscle of FIG. 18 showing the linear thermal treatment zone.

20 is an orthogonal cross-section through the porcine muscle of FIG. 19 illustrating the planar thermal treatment zone.

21 is a cross-sectional view of a combined imaging and cylindrical therapy transducer in accordance with an embodiment of the present invention.

22 is a side view of the combined imaging and cylindrical therapy transducer according to FIG. 21 .

23 is a graph showing harmonic pressure across azimuth for an embodiment of a cylindrical element having imaging elements.

24 is a graph showing harmonic pressure across azimuth for an embodiment of a coated cylindrical element having an imaging element.

25 is a graph showing harmonic pressure across azimuth for an embodiment of a cylindrical element with imaging elements compared to an embodiment of a coated cylindrical element with imaging elements.

26 is a side view of a coated transducer including a cylindrical transducing element having one or more coated regions in accordance with an embodiment of the present invention.

27 is a graph showing focal gain across azimuth for two embodiments of cylindrical transducing elements.

28 is a schematic diagram illustrating a normalized pressure distribution at a depth of approximately 5 mm distal to the focal zone according to an embodiment of a coated transducer comprising a cylindrical transducing element having one or more coated regions.

29 is a schematic diagram illustrating a standard pressure distribution at the focal depth according to the embodiment of the coated transducer of FIG. 28 .

30 is a schematic diagram illustrating a standard pressure distribution at a depth of approximately 2 mm proximal to the focal depth according to the embodiment of the covered transducer of FIG. 28 .

31 is a side view of a covered transducer according to an embodiment of the present invention.

32 is a side view of a covered transducer according to an embodiment of the present invention.

33 is a side view of a covered transducer according to an embodiment of the present invention.

34 is a side view of a covered transducer according to an embodiment of the present invention.

35 is a side view of a covered transducer according to an embodiment of the present invention.

36 is a side view of a covered transducer according to an embodiment of the present invention.

37 is a side view of a covered transducer according to an embodiment of the present invention.

38 is a side view of a covered transducer according to an embodiment of the present invention.

39 shows a graph showing the relationship between time and temperature for obtaining various theoretical cell kill ratios according to one embodiment of the present invention.

40 shows a graph of time and temperature dependence for obtaining various theoretical cell kill ratios according to one embodiment of the present invention.

41 is a table listing equivalent doses to achieve a theoretical 1% survival rate in tissue, listing temperatures and times, according to an embodiment of the present invention.

42 is a graph showing time and temperature dependence of equivalent dose for cell survival rate according to an embodiment of the present invention.

43 represents a simulation of the output of a cylindrical transducer showing the linear superposition of multiple pulses, in accordance with an embodiment of the present invention.

44 is a top view of an apodizing transducer according to an embodiment of the present invention.

FIG. 45 shows a sound pressure profile with an apodized transducer according to the embodiment of FIG. 44 .

46 is a graph illustrating a temperature profile of an embodiment from an in vivo porcine model therapeutic dosing study according to an embodiment of the present invention.

47 is a diagram of a setup for an equivalent dose study according to an embodiment of the present invention.

48 shows cumulative dose as a function of time, temperature, and pass count for a treatment study, according to one embodiment of the present invention.

49 is a table with target temperatures and times for a treatment study according to an embodiment of the present invention.

50 is a table of different embodiments of transducer therapy settings for an equivalent thermal dose therapy study, according to an embodiment of the present invention.

51 is an image of a site of thermal overdose caused by a transducer, in accordance with an embodiment of the present invention.

52 is a graph relating time and temperature to target object temperature according to an embodiment of the present invention.

53 is an isometric side view of a transducer and treatment area, according to an embodiment of the present invention.

54 is a graph showing velocity and position along an axis according to one embodiment of the present invention.

55 is a graph showing velocity and position along an axis according to one embodiment of the present invention.

56 is a graph showing amplitude and position along an axis according to an embodiment of the present invention.

57 is a graph showing velocity and position along an axis according to one embodiment of the present invention.

58 is a graph showing velocity and position along an axis according to one embodiment of the present invention.

Figure 59 illustrates non-overlapping treatments according to an embodiment of the present invention.

FIG. 60 illustrates partially overlapping and partially non-overlapping treatments according to an embodiment of the present invention.

Figure 61 shows a treatment area according to various embodiments of the present invention.

Figure 62 is a graph showing intensity and depth according to one embodiment of the present invention.

63 is an isometric side view of a transducer and treatment area having multiple thermal treatment zones in accordance with an embodiment of the present invention.

64 is a schematic side view of a system including multiple ultrasonic elements on a motion mechanism according to an embodiment of the present invention.

DETAILED DESCRIPTION

The following description sets forth examples of embodiments, which are not intended to limit the present invention or its teachings, applications or uses. It should be understood that in all the accompanying drawings, corresponding reference numerals represent identical or corresponding parts and features. The description of the specific examples proposed in different embodiments of the present invention is for illustrative purposes only and is not intended to limit the scope of the present invention disclosed herein. In addition, the repetition of multiple embodiments with stated features is not intended to exclude other embodiments with additional features or other embodiments comprising different combinations of stated features. In addition, the features in one embodiment (e.g., in one accompanying drawing) can be combined with the description (and accompanying drawings) of other embodiments.

In various embodiments, systems and methods for ultrasonic treatment of tissue are configured to provide cosmetic treatments. Various embodiments of the present invention address the potential challenges posed by administering ultrasonic treatments. In various embodiments, the time and/or amount of energy required to create a thermal treatment zone (also referred to herein as a "TTZ") in order to perform the desired cosmetic and/or therapeutic treatment of a desired clinical method at a target tissue is reduced. In various embodiments, ultrasonic energy is used to non-invasively treat tissues below or at the surface of the skin, such as the epidermis, dermis, platysma muscle, lymph nodes, nerves, fascia, muscle, fat, and/or the superficial musculoaponeurotic system ("SMAS"). In various embodiments, tissues below or at the surface of the skin, such as the epidermis, dermis, platysma muscle, lymph nodes, nerves, fascia, muscle, fat, and/or SMAS, are not treated. The ultrasonic energy can be focused on one or more treatment zones, can be unfocused and/or defocused, and can be applied to an area of interest to achieve a cosmetic and/or therapeutic effect. In various embodiments, the systems and/or methods provide non-invasive dermatological treatment to tissue by heating, thermal therapy, coagulation, ablation, and/or tissue contraction (including, for example, hyperthermia, thermal dosimetry, apoptosis, and lysis). In one embodiment, skin tissue volume is increased. In one embodiment, adipose tissue volume is decreased or reduced.

In various embodiments, the target tissue is, but is not limited to, any of the following: skin, eyelids, eyelashes, eyebrows, caruncle, crow's feet, wrinkles, eyes, nose, mouth, tongue, teeth, gums, ears, brain, chest, back, buttocks, legs, arms, hands, armpits, heart, lungs, ribs, abdomen, stomach, liver, kidneys, uterus, breasts, vagina, penis, prostate, testicles, glands, thyroid gland, internal organs, hair, muscle, bone, ligament, cartilage, fat, fat lobules, adipose tissue, cellulite, subcutaneous tissue, implanted tissue, implanted organ, lymph, tumor, cyst, abscess, or a portion of a nerve, or any combination thereof. In several embodiments disclosed herein, non-invasive ultrasound is used to achieve one or more of the following effects: facial wrinkle reduction, brow lift, chin lift, eye treatment, wrinkle removal, scar removal, fat reduction, reduction in the appearance of cellulite, skin wrinkle treatment, burn treatment, tattoo removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, acne treatment, and pimple removal. In some embodiments, two, three, or more beneficial effects are achieved during the same treatment period, and may be achieved simultaneously.

Various embodiments of the present invention relate to devices or methods for controlling the delivery of energy to tissue. In various embodiments, the different forms of energy may include sound, ultrasound, light, laser, radio frequency (RF), microwave, electromagnetic, radiation, heat, cryogenics, electron beams, photon-based, magnetic, magnetic resonance, and/or other energy forms. Various embodiments of the present invention relate to devices or methods for splitting an ultrasound energy beam into multiple beams. In various embodiments, the devices or methods can be used to alter the delivery of ultrasonic acoustic energy in any procedure, such as, but not limited to, therapeutic ultrasound, diagnostic ultrasound, non-destructive testing (NDT) using ultrasound, ultrasonic welding, any application involving coupling mechanical waves to an object, and other processes. Generally speaking, for therapeutic ultrasound, tissue effects are achieved by concentrating acoustic energy using aperture-based focusing techniques. In some cases, high-intensity focused ultrasound (HIFU) is used in this manner for therapeutic purposes. In one embodiment, the tissue effect created by applying therapeutic ultrasound at a specific location (e.g., depth, width) can be referred to as the creation of a thermal treatment zone. By creating a thermal treatment zone at a specific location, thermal and/or mechanical heating, coagulation, and/or ablation of tissue can be performed non-invasively or remotely offset from the skin surface.

System Overview

Various embodiments of ultrasound treatment and/or imaging devices are described in US Patent Application Publication No. 2011-0112405, which is a national phase publication from International Publication No. WO 2009/149390, both of which are incorporated herein by reference in their entirety.

1 , an embodiment of the ultrasound system 20 includes a handle 100, a module 200, and a controller 300. The handle 100 can be coupled to the controller 300 via an interface 130, which can be a wired or wireless interface. The interface 130 can be coupled to the handle 100 via a connector 145, and the distal end of the interface 130 can be connected to a controller connector on a circuit 345. In one embodiment, the interface 130 can transmit controllable power from the controller 300 to the handle 100. In various embodiments, the controller 300 can be configured to operate in conjunction with the handle 100 and the module 200, as well as to operate the functions of the entire ultrasound system 20. In various embodiments, the controller 300 is configured for operation with a handle 100 having one or more removable modules 200, 200', 200", etc. The controller 300 may include an interactive graphical display 310, which may include a touch screen monitor and a graphical user interface (GUI) that allows a user to interact with the ultrasound system 20. As shown, the graphical display 315 includes a touch screen interface 315. In various embodiments, the display 310 sets and displays operating conditions, including device activation status, treatment parameters, system messages and prompts, and ultrasound images. In various embodiments, the controller 300 may be configured, for example, to include a computer having software and input/output devices. The controller 300 may include a system processor and various analog and/or digital control logic, such as one or more of a microcontroller, a microprocessor, a field programmable gate array, a computing board, and related components, including firmware and control software, which can interface with user control and interface circuits and software for communication, The controller 300 may include input/output circuits and system connections for display, interface connections, storage, file organization, and other useful functions. The system software running on the system program may be configured to control all initialization, timing, level setting, monitoring, safety monitoring, and all other ultrasound system functions used to achieve user-defined treatment objectives. In addition, the controller 300 may include various input/output modules, such as switches, buttons, etc., which may also be appropriately configured to control the operation of the ultrasound system 20. In one embodiment, the controller 300 may include one or more data ports 390. In different embodiments, the data port 390 may be a USB port, a Bluetooth port, an infrared data port, a parallel port, a serial port, etc. The data port 390 may be located on the front, side, and/or rear of the controller 300 and may be used to access a storage device, a printing device, a computing device, and the like. The ultrasound system 20 may include a lock 395. In one embodiment, to operate the ultrasound system 20, the lock 395 should be unlocked so that the power switch 393 can be activated. In one embodiment, the lock 395 may be connected to the controller 300 via the data port 390 (e.g., a USB port). The lock 395 may be unlocked by inserting an access key (e.g., a USB access key), a hardware dongle, etc. into the data port 390. The controller 300 may include an emergency stop button 392 that is easily accessible for emergency deactivation.

As shown in FIG1 , in one embodiment, the handle 100 includes one or more finger-activated controls or switches, such as 150 and 160. In one embodiment, the handle 100 may include a removable module 200. In other embodiments, the module 200 may not be removable. The module 200 may be mechanically coupled to the handle 100 using a latch or coupler 140. An interface guide 235 may be used to assist in coupling the module 200 to the handle 100. The module 200 may include one or more ultrasonic transducers 280. In some embodiments, the ultrasonic transducer 280 includes one or more ultrasonic elements 281. The module 200 may include one or more ultrasonic elements 281. The elements 281 may be therapeutic elements and/or imaging elements. The handle 100 may include an imaging-only module 200, a therapy-only module 200, an imaging and therapy module 200, and the like. In one embodiment, imaging is provided by the handle 100. In one embodiment, the control module 300 can be coupled to the handle 100 via the interface 130, and the graphical user interface 310 can be configured to control the module 200. In one embodiment, the control module 300 can provide power to the handle 100. In one embodiment, the handle 100 can include a power supply. In one embodiment, the switch 150 can be configured to control the tissue imaging function, and the switch 160 can be configured to control the tissue treatment function.

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

In various embodiments, ultrasound energy is used to non-invasively treat tissue beneath or even at the skin's surface (e.g., the epidermis, dermis, subcutaneous tissue, fascia, SMAS, and/or muscle). The tissue may also include blood vessels and/or nerves. The ultrasound energy may be focused, unfocused, or defocused and applied to a region of interest to achieve a therapeutic effect, the region of interest including at least one of the epidermis, dermis, subcutaneous tissue, fascia, and SMAS. FIG2 is a schematic diagram of an ultrasound system 20 coupled to a region of interest 10, for example, using acoustic gel. Referring to the diagram in FIG2 , an embodiment of the ultrasound system 20 includes a handle 100, a module 200, and a controller 300. In various embodiments, the tissue layer of the region of interest 10 may be located anywhere on the patient's body. In various embodiments, the tissue layer is located in the patient's head, face, neck, and/or other body regions. A cross-sectional portion of the tissue of the region of interest 10 includes a skin surface 501, an epidermal layer 502, a dermal layer 503, a fat layer 505, a SMAS 507, and a muscle layer 509. Tissue can also include hypodermis 504, which can include any tissue below the dermis 503. The combination of these layers can be referred to as subcutaneous tissue 510 as a whole. Treatment area 525 is also shown in Figure 2, which is the active treatment area below surface 501. In one embodiment, surface 501 can be the surface of the skin of patient 500. Although the embodiments for the treatment of tissue layers can be used as examples in this article, the system can be applied to any tissue in the body. In different embodiments, the system and/or method can be used on the muscles (or other tissues) of any other position in the face, neck, head, arms, legs, or body. In different embodiments, treatment can be applied to the face, head, neck, submental area, shoulders, arms, back, chest, buttocks, abdomen, stomach, waist, flanks, legs, thighs, or any other position in or on the body.

Belt therapy using a cylindrical transducer

In various embodiments, the transducer 280 can include one or more therapeutic elements 281, which can have various shapes corresponding to various focal zone geometries. In one embodiment, the transducer 280 includes a single therapeutic element 281. In one embodiment, the transducer 280 does not have a plurality of elements. In one embodiment, the transducer 280 does not have an array of elements. In several embodiments, the transducers 280 and/or therapeutic elements 281 described herein can be flat, spherical, circular, cylindrical, annular, have a ring, concave, convex, contoured, and/or have any shape. In some embodiments, the transducers 280 and/or therapeutic elements 281 described herein are not flat, spherical, circular, cylindrical, annular, have a ring, concave, convex, and/or contoured. In one embodiment, the transducer 280 and/or therapeutic element 281 have mechanical focusing. In one embodiment, the transducer 280 and/or therapeutic element 281 do not have mechanical focusing. In one embodiment, the transducer 280 and/or therapeutic element 281 has electrical focusing. In one embodiment, the transducer 280 and/or therapeutic element 281 does not have electrical focusing. Although cylindrical transducers and/or cylindrical elements are discussed herein, the transducers and/or elements need not be cylindrical. In several embodiments, the transducers and/or elements have one or more shapes or configurations that cause edge effects, such as differences, spikes, or other inconsistencies in the transmission of ultrasound waves. For example, the transducers and/or elements may have one or more nonlinear (e.g., curved) portions. The transducer may be comprised of one or more individual transducers and/or elements in any combination of focused, planar, or unfocused single element, multi-element, or array transducers (including 1-dimensional, 2-dimensional, and annular arrays; linear, curvilinear, sectoral, or spherical arrays; spherically, cylindrically, and/or electronically focused, defocused, and/or lensed sources). In one embodiment, the transducer is not a multi-element transducer. In one embodiment, the transducer 280 can include a spherical bowl having a diameter and one or more concave surfaces (having respective radii or diameters) that geometrically focus to a single point, TTZ 550, at a focal depth 278 below a tissue surface (e.g., skin surface 501). In one embodiment, the transducer 280 can be radially symmetric in three dimensions. For example, in one embodiment, the transducer 280 can be a radially symmetric bowl configured to produce a focus at a single point in space. In some embodiments, the transducer is not spherical. In some embodiments, the element is not spherical.

In various embodiments, increasing the size (e.g., width, depth, area) and/or number of focal zone locations used for ultrasound procedures can be advantageous because it allows for treatment of a patient at a variety of tissue widths, heights, and/or depths, even if the focal depth 278 of the transducer 280 is fixed. This can provide synergistic results and maximize the clinical outcome of a single treatment session. For example, treatment at a larger treatment area under a single surface area allows for a larger total volume of tissue treatment, which can heat a larger volume of tissue and lead to enhanced collagen formation and tightening. Additionally, larger treatment areas, for example, at different depths, affect different types of tissue, thereby producing different clinical effects, which together provide an enhanced overall cosmetic outcome. For example, surface treatment can reduce the visibility of wrinkles, while deeper treatment can induce skin tightening and/or collagen growth. Similarly, treatment at various locations at the same or different depths can improve treatment. In various embodiments, a transducer with a larger focal zone (e.g., a linear focal zone compared to a point focal zone) can be used to achieve a larger treatment area.

In one embodiment, as shown in Figures 3 and 4, the transducer 280 includes a cylindrical transducer element 281. In Figure 4, a view of the cylindrical transducer element 281 having a concave surface 282 and a convex surface 283 is cut away to illustrate energy transmission from the concave surface to the linear TTZ 550. The cylindrical transducer element 281 extends linearly along its longitudinal axis (X-axis, azimuth) and has a curved cross-section along the Y-axis (elevation). In one embodiment, the cylindrical surface has a radius at a focal depth (z-axis) at the center of curvature of the cylindrical surface such that the TTZ 550 is focused at the center of the radius. For example, in one embodiment, the cylindrical transducer element 281 has a concave surface that extends like a cylinder, which creates a focal zone, such as the TTZ 550, that extends along a line (e.g., a treatment line). The focal zone TTZ 550 extends along the width of the cylindrical transducer element 281 (along the X-axis, azimuth) on a line parallel to the longitudinal axis of the cylindrical transducer element 281. As shown in FIG3, the TTZ 550 is a line that extends into and/or out of the page. In various embodiments of the cylindrical transducer element 281, a concave surface directs the ultrasonic energy into the linear TTZ 550. The cylindrical transducer element 281 need not be cylindrical; in some embodiments, the element 281 is a transducer element having one or more curved or nonlinear portions.

In various embodiments, the transducer 280 can include one or more transducer elements 281. The transducer element 281 can include a piezoelectrically active material, such as lead zirconate titanate (PZT) or any other piezoelectrically active material, such as piezoelectric ceramics, crystals, plastics, and/or composite materials, as well as lithium niobate, lead titanate, barium titanate, and/or lead metaniobate. In various embodiments, the transducer can include any other material configured to generate radiative and/or acoustic energy in addition to or in place of the piezoelectrically active material. In one embodiment, when the cylindrical transducer element 281 includes a piezoelectric ceramic material excited by electrical stimulation, the material can expand or contract. The amount of expansion or contraction is related to the boundary conditions in the ceramic and the magnitude of the electric field generated in the ceramic. In some embodiments of conventional high-intensity focused ultrasound (HIFU) designs, the front surface (e.g., the patient side) is coupled to water, and the back surface of the transducer 280 is coupled to a low-impedance medium, typically air. In some embodiments, although the ceramic is free to expand at the rear interface, due to the significant difference in acoustic impedance, substantially no mechanical energy is coupled from the ceramic to the air. This causes this energy at the back of the ceramic to reflect and exit the front (or patient-side) surface. As shown in the embodiment of Figures 3-5B, the focus is created by forming, casting, and/or machining the ceramic to the correct radius of curvature. In one embodiment, the flat transducer material is bent to form a cylindrical transducer. In various embodiments, the transducer 280 and/or the therapeutic element 281 can be configured to operate at different frequencies and treatment depths. The transducer properties can be determined by the focal length ( _FL ), which is sometimes referred to as the focal depth 278. The focal depth 278 is the distance from the concave cylindrical surface to the focal zone TTZ 550. In various embodiments, the focal depth 278 is the sum of the standoff distance 270 and the treatment depth 279 when the housing of the probe is placed against the skin surface. In one embodiment, the standoff distance 270 or offset distance 270 is the distance between the transducer 280 and the surface of the acoustically transparent component 230 on the probe housing. The treatment depth 279 is the tissue depth 279 below the skin surface 501 to the target tissue. In one embodiment, the height of the aperture in the curved dimension is increased or maximized to have a direct impact on the overall focal gain related to the ability to heat tissue. For example, in one embodiment, the height of the aperture in the curved dimension is maximized for treatment depths of 6 mm or less. In one embodiment, as the aperture is increased (e.g., the aperture is reduced), the actual heating area becomes closer to the surface.

In one embodiment, the transducer can be configured to have a focal depth 278 of 6 mm, 2-12 mm, 3-10 mm, 4-8 mm, or 5-7 mm. In other embodiments, other suitable values of focal depth 278 can be used, such as a focal depth 278 of less than about 15 mm, greater than about 15 mm, 5-25 mm, 10-20 mm, etc. The transducer module can be configured to apply ultrasonic energy at different target tissue depths. In one embodiment, the treatment is 20 mm or less (e.g., 0.1 mm-20 mm, 5-17 mm, 10-15 mm). In one embodiment, a device that reaches 6 mm or less has a radius of curvature (ROC) of 13.6 mm, and the ratio of treatment depth to ROC is approximately 44%. In one embodiment, the height of the element is 22 mm. In one embodiment, using an aspect ratio of a treatment depth of 20 mm, the aperture height will be 74.5 mm and the ROC will be 45 mm.

As shown in Figures 5A-5B, 7, 9, and 10, in several embodiments, the system can include a movement mechanism 285 configured to move the transducer 280, including the cylindrical transducing element 281, in one, two, three, or more directions. In one embodiment, the movement mechanism 285 can move in one or two linear directions, indicated by arrows labeled 290, to move the TTZ 550 through the tissue. In various embodiments, the movement mechanism 285 can move the transducer in one, two, and/or three linear dimensions and/or in one, two, and/or three rotational dimensions. In one embodiment, the movement mechanism 285 can move in up to six degrees of freedom. Movement of the TTZ 550 can be accompanied by continuous energy delivery from the transducer to create a treatment zone 552. In one embodiment, the movement mechanism 285 can automatically move the cylindrical transducing element 281 across the surface of the treatment zone so that the TTZ 550 can form the treatment zone 552.

As shown in Figures 6, 7, and 8, a cylindrical transducer element 281 can be connected to a motion mechanism 285 and placed within the module 200 or probe. In various embodiments, the motion mechanism 285 or movement mechanism 285 moves the transducer 280 and/or treatment element 281, causing the corresponding TTZ 550 to move to treat a larger treatment area 552. In various embodiments, the motion mechanism 285 is configured to move the transducer within the module or probe. In one embodiment, the transducer is held by a transducer holder. In one embodiment, the transducer holder comprises a sleeve that moves along a motion-constraining bearing, such as a linear bearing, i.e., a rod (or shaft), to ensure repeatable linear motion of the transducer. In one embodiment, the sleeve is a splined bushing that prevents rotation about a splined shaft, but any guide that maintains a motion path is suitable. In one embodiment, the transducer holder is driven by the motion mechanism 285, which can be located in the handle, the module, or the probe. In one embodiment, the motion mechanism 285 comprises any one or more of a scotch yoke, a motion member, and a magnetic coupling. In one embodiment, magnetic coupling facilitates movement of the transducer. One benefit of the motion mechanism 285 is that it provides for more efficient, precise, and accurate use of the ultrasound transducer for imaging and/or therapeutic purposes. Compared to conventional fixed arrays of multiple transducers fixed in space within a housing, one advantage of this type of motion mechanism is that the fixed arrays are separated by a fixed distance. By placing the transducers on a track (e.g., a linear track) under the control of a controller, embodiments of the system and apparatus provide adaptability and flexibility in addition to efficiency, precision, and accuracy. Imaging and therapeutic positioning can be adjusted in real time or near real time along the controlled motion of the motion mechanism 285. In addition to the ability to select virtually any resolution based on incremental adjustments possible through the motion mechanism 285, adjustments can also be made if imaging detects abnormalities or conditions that favor changes in treatment spacing and targeting. In one embodiment, one or more sensors can be included in the module. In one embodiment, one or more sensors can be included in the module to ensure that the mechanical coupling between the moving member and the transducer holder is indeed coupled. In one embodiment, the encoder can be located on top of the transducer holder and the sensor can be located in a portion of the module, or vice versa (interchangeable). In various embodiments, the sensor is a magnetic sensor, such as a giant magnetoresistance (GMR) or Hall effect sensor, and the encoder is a magnet, a magnet collection, or a multi-pole magnetic strip. The sensor can be positioned as the initial position of the transducer module. In one embodiment, the sensor is a contact pressure sensor. In one embodiment, the sensor is a contact pressure transducer on the surface of the device to sense the position of the device or transducer on the patient. In various embodiments, the sensor can be used to map the position of the device or components in the device in one, two, or three dimensions. In one embodiment, the sensor is configured to sense the position, angle, tilt, orientation, arrangement, elevation, or other relationship between the device (or components therein) and the patient. In one embodiment, the sensor comprises an optical sensor. In one embodiment, the sensor comprises a ball bearing sensor. In one embodiment, the sensor is configured to map positions in one, two, and/or three dimensions to calculate the distance between treatment areas or lines on the skin or tissue on the patient.

In various embodiments, motion mechanism 285 can be any mechanism that can be found useful for moving the transducer. In one embodiment, motion mechanism 285 comprises a stepper motor. In one embodiment, motion mechanism 285 comprises a worm gear. In various embodiments, motion mechanism 285 is located in module 200. In various embodiments, motion mechanism 285 is located in handle 100. In various embodiments, motion mechanism 285 can provide linear, rotational, or multi-dimensional motion or actuation, and motion can include any collection of points, lines, and/or orientations in space. According to several embodiments, various embodiments for motion can be used, including but not limited to linear, circular, elliptical, arc-shaped, spiral, a collection of one or more points in space, or any other embodiment of motion with 1-, 2-, or 3-dimensional positions and postures. The speed of motion mechanism 285 can be fixed or adjustable by the user. In one embodiment, the speed of motion mechanism 285 used for image sequences can be different from the speed of motion mechanism used for treatment sequences. In one embodiment, the speed of motion mechanism 285 can be controlled by a controller.

In some embodiments, the energy delivered from the transducer is turned on and off to form a non-contiguous treatment zone 552, so that the TTZ 550 moves at treatment intervals between the various TTZ 550 positions. For example, the treatment intervals can be approximately 1 mm, 1.5 mm, 2 mm, 5 mm, 10 mm, etc. In several embodiments, the probe can further include a movement mechanism configured to direct the ultrasound treatment in a sequence such that the plurality of TTZs 550 are formed in a linear or substantially linear sequence. For example, the transducer module can be configured to form the plurality of TTZs 550 along a first linear sequence and a second linear sequence, the second linear sequence being separated from the first linear sequence by a treatment interval of between approximately 2 mm and 3 mm. In one embodiment, a user can manually move the transducer module across the surface of the treatment area to create a plurality of adjacent linear sequences of TTZs.

In one embodiment, the TTZ can be swept from a first position to a second position. In one embodiment, the TTZ can be repeatedly swept from a first position to a second position. In one embodiment, the TTZ can be swept from a first position to a second position and back to the first position. In one embodiment, the TTZ can be swept from a first position to a second position and back to the first position, and repeat. In one embodiment, multiple sequences of TTZs can be created in the treatment area. For example, multiple TTZs can be formed along a first linear sequence and a second linear sequence spaced apart from the first linear sequence by a treatment distance.

In one embodiment, the TTZs can be created in a linear or substantially linear zone or sequence, where each individual TTZ is separated from adjacent TTZs by a treatment interval, as shown in FIG9 . FIG9 illustrates an embodiment of an ultrasound system 20 with a transducer 280 configured to treat tissue at a focal depth 278. In one embodiment, focal depth 278 is the distance between the transducer 280 and the target tissue for treatment. In one embodiment, focal depth 278 is fixed for a given transducer 280. In one embodiment, focal depth 278 is variable for a given transducer 280. As shown in FIG9 , in various embodiments, module 200, through controlled operation of control system 300, provides delivery of transmitted energy 50 at an appropriate focal depth 278, distribution, timing, and energy level to achieve the desired therapeutic effect of controlled thermal injury, thereby treating at least one of the epidermis 502, dermis 503, fat 505, SMAS 507, muscle 509, and/or hypodermis 504. FIG9 illustrates a depth embodiment corresponding to the depth used to treat muscle. In various embodiments, the depth can correspond to any tissue, tissue layer, skin, epidermis, dermis, hypodermis, fat, SMAS, muscle, blood vessels, nerves, or other tissue. During operation, the module 200 and/or transducer 280 can also mechanically and/or electronically scan along the surface 501 to treat an extended area. Before, during, and after the delivery of ultrasonic energy 50 to at least one of the epidermis 502, dermis 503, hypodermis 504, fat 505, SMAS 507, and/or muscle 509, the treatment area and surrounding structures can be monitored to plan and assess results and/or provide feedback to the controller 300 and the user via the graphical interface 310. In one embodiment, the ultrasound system 20 generates ultrasonic energy that is directed and focused beneath the surface 501. The controlled and focused ultrasonic energy 50 creates a thermal treatment zone (TTZ) 550. In one embodiment, the TTZ 550 is a line. In another embodiment, the TTZ 550 is a point. In one embodiment, the TTZ 550 is a two-dimensional area or plane. In one embodiment, the TTZ 550 is a volume. In one embodiment, the ultrasound energy 50 thermally treats the subcutaneous tissue 510. In various embodiments, the emitted energy 50 targets tissue beneath the surface 501, heating, cutting, ablating, coagulating, micro-ablating, massaging, and/or causing damage to the tissue portion 10 beneath the surface 501. In one embodiment, during the treatment sequence, the transducer 280 moves in the direction indicated by the arrow labeled 290 to move the TTZ 550.

In various embodiments, the active TTZ can be moved (continuously or non-continuously) through the tissue to form a treatment area 552, as shown in FIG. 10 . Referring to the illustration in FIG. 10 , the module 200 can include a transducer 280 that can transmit energy through the acoustically transparent component 230. In various embodiments, depth can refer to a focal depth 278. In one embodiment, the transducer 280 can have an offset distance 270, which is the distance between the transducer 280 and the surface of the acoustically transparent component 230. In one embodiment, the focal depth 278 of the transducer 280 is a fixed distance from the transducer. In one embodiment, the transducer 280 can have a fixed offset distance 270 from the transducer to the acoustically transparent component 230. In one embodiment, the acoustically transparent component 230 is configured at a location on the module 200 or ultrasound system 20 for contacting the skin surface 501. In various embodiments, the focal depth 278 exceeds the offset distance 270 by an amount corresponding to treatment at a target area located at a tissue depth 279 below the skin surface 501. In various embodiments, when the ultrasound system 20 is placed in physical contact with the skin surface 501, the tissue depth 279 is the distance between the acoustically transparent component 230 and the target area, measured from the portion of the handle 100 or module 200 surface contacting the skin (with or without acoustic coupling gel, medium, etc.) to the depth in the tissue from the skin surface contact point to the target area. In one embodiment, in addition to the tissue depth 279 below the skin surface 501 to the target area, the focal depth 278 can correspond to the sum of the offset distance 270 (measured to the surface of the acoustically transparent component 230 in contact with the coupling medium and/or skin 501) and the tissue depth. In various embodiments, the acoustically transparent component 230 is not used.

In various embodiments, by using transducers configured to deliver energy to an expanded TTZ, therapeutic treatment can advantageously be provided at a faster rate and with improved precision. This, in turn, can reduce treatment time and reduce pain experienced by the patient. In several embodiments, treatment time is reduced by creating a TTZ and sweeping the TTZ across an area or volume treated by a single transducer. In some embodiments, it is desirable to reduce treatment time and the corresponding risk of pain and/or discomfort experienced by the patient. By forming a larger TTZ 550, forming multiple TTZs simultaneously, nearly simultaneously, or sequentially, and/or moving the TTZ 550 to form a larger treatment area 552, treatment time can be reduced by treating a larger area in a given time. In one embodiment, by treating a given area or volume with multiple TTZs, the total amount of movement of the device is reduced, thereby reducing treatment time. In some embodiments, by creating a continuous treatment zone 552 or discrete, segmented treatment zones 552 from a series of individual TTZs, the total treatment time can be reduced by 10%, 20%, 25%, 30%, 35%, 40%, 4%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, or more. In various embodiments, the treatment time can be reduced by 10-25%, 30-50%, 40-80%, 50-90%, or approximately 40%, 50%, 60%, 70%, and/or 80%. While treating a patient at different locations during a treatment session may be advantageous in some embodiments, in other embodiments, sequential treatment over time may be beneficial. For example, a patient may be treated at one depth at time one, at a second depth at time two, and so on, at the same surface area. In various embodiments, the time period may be on the order of nanoseconds, microseconds, milliseconds, seconds, minutes, hours, days, weeks, months, or other lengths of time. For example, in some embodiments, the transducer modules are configured to deliver energy with an on-time of 10 ms-100 minutes (e.g., 100 ms, 1 second, 1-60 seconds, 1 minute-10 minutes, 1 minute-60 minutes, and any range therein). The new collagen produced by the first treatment may be more sensitive to subsequent treatments, which may be desirable for some indications. Alternatively, multiple depth treatments under the same surface area in a single treatment session may be advantageous because treatment at one depth can synergistically enhance or supplement treatment at another depth (e.g., due to enhanced blood flow, stimulation of growth factors, hormone stimulation, etc.). In several embodiments, different transducer modules provide treatment at different depths. In one embodiment, a single transducer module can be adjusted or controlled for a variety of depths.

In one embodiment, a cosmetic treatment system includes an ultrasound probe having a removable module, the removable module including an ultrasound transducer configured to apply ultrasound treatment to tissue at a focal zone. 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 two-dimensional region or plane. In one embodiment, the focal zone is a volume. In various embodiments, the focal zone can be moved to sweep the volume between a first position and a second position. In various embodiments, one or more focal zone positions are located in a substantially linear sequence within a cosmetic treatment zone. In one embodiment, a first set of positions is located within a first cosmetic treatment zone, and a second set of positions is located within a second cosmetic treatment zone, the first zone being different from the second zone. In one embodiment, the first cosmetic treatment zone comprises a substantially linear sequence of the first set of positions, and the second cosmetic treatment zone comprises a substantially linear sequence of the second set of positions.

In one embodiment, the transducer module 280 can provide acoustic power within a range of about 1 W or less, between about 1 W and about 100 W, and greater than about 100 W. In one embodiment, the transducer module 280 can provide acoustic power at a frequency of about 1 MHz or less, between about 1 MHz and about 10 MHz, and greater than about 10 MHz. In one embodiment, the module 200 has a focal depth 278 for treatment at a tissue depth 279 of about 4.5 mm below the skin surface 501. Some non-limiting embodiments of the transducer 280 or module 200 can be configured to deliver ultrasonic energy at a tissue depth of 3 mm, 4.5 mm, 6 mm, less than 3 mm, between 3 mm and 4.5 mm, between 4.5 mm and 6 mm, greater than 4.5 mm, greater than 6 mm, etc., and anywhere in the range of 0.1-3 mm, 0.1-4.5 mm, 0.1-6 mm, 0.1-25 mm, 0.1-100 mm, etc., and any depth therein. In one embodiment, the ultrasound system 20 is provided with two or more removable transducer modules 280. In one embodiment, the transducers 280 can apply treatment at a tissue depth (e.g., about 6 mm). For example, a first transducer module can apply treatment at a first tissue depth (e.g., about 4.5 mm), a second transducer module can apply treatment at a second tissue depth (e.g., about 3 mm), and a third transducer module can apply treatment at a third tissue depth (e.g., about 1.5-2 mm). In one embodiment, at least some or all of the transducer modules can be configured to apply treatment at substantially the same depth. In various embodiments, the tissue depth can be 1.5 mm, 2 mm, 3 mm, 4.5 mm, 7 mm, 10 mm, 12 mm, 14 mm, 15 mm, 17 mm, 18 mm, and/or 20 mm, or any range thereof (including, but not limited to, 12-20 mm, or higher).

In one embodiment, the transducer module enables a treatment sequence at a fixed depth at or below the skin surface. In one embodiment, the transducer module enables a treatment sequence at a range of depths below the skin surface. In several embodiments, the transducer module includes a movement mechanism configured to move the ultrasound treatment within the TTZ. In one embodiment, the linear sequence of individual TTZs has a treatment interval within a range from about 0.01 mm to about 25 mm. For example, the interval can be 1.1 mm or less, 1.5 mm or greater, between about 1.1 mm and about 1.5 mm, etc. In one embodiment, the individual TTZs are discrete. In one embodiment, the individual TTZs overlap. In one embodiment, the movement mechanism is configured to be programmed to provide variable spacing between the individual TTZs. In several embodiments, the transducer module includes a movement mechanism configured to sequentially direct the ultrasound treatment such that the TTZs are formed in a linear or substantially linear sequence separated by a treatment distance. For example, the transducer module can be configured to form the TTZs along a first linear sequence and a second linear sequence separated from the first linear sequence by a treatment distance. In one embodiment, the treatment distance between adjacent linear sequences of individual TTZs is in a range from about 0.01 mm to about 25 mm. For example, the treatment distance can be 2 mm or less, 3 mm or greater, between about 2 mm and about 3 mm, and so on. In several embodiments, the transducer module can include one or more movement mechanisms configured to direct ultrasound treatment in a sequence such that the TTZs are formed as linear or substantially linear sequences of individual thermal lesions separated from other linear sequences by a treatment distance. In one embodiment, the treatment distances separating the linear or substantially linear TTZ sequences are the same or substantially the same. In one embodiment, the treatment distances separating the linear or substantially linear TTZ sequences are different or substantially different for each adjacent pair of linear TTZ sequences.

Belt therapy using a cylindrical transducer with an imaging element

In various embodiments, an imaging transducer or an imaging element having a cylindrical transducer element 281 can be used to improve the safety and/or efficacy of treatment. In one embodiment, the imaging element can be used to confirm acceptable coupling between ultrasound therapy transducers and/or identify target tissue beneath the skin's surface. As shown in Figures 21 and 22, in various embodiments, the transducer 280 includes a cylindrical transducer element 281 and one or more imaging elements 284. The imaging element 284 is configured to image a region of interest at any suitable tissue depth 279. In one embodiment, the imaging element is centered about the therapeutic element. In one embodiment, the imaging element and the therapeutic element are axisymmetric. In one embodiment, the imaging element and the therapeutic element are not axisymmetric. In one embodiment, the imaging axis can point in a completely different direction and be translated from the treatment beam axis. In one embodiment, the number of imaging elements in the aperture can be greater than one. For example, in one embodiment, an imaging element can be located at each corner of a cylinder pointing straight ahead and/or in the middle. In one embodiment, a combined imaging and cylindrical therapy transducer 280 includes a cylindrical transducer element 281 and one or more imaging elements 284. In one embodiment, the combined imaging and cylindrical therapy transducer 280 includes a cylindrical transducing element 281 having an opening 285 through which an imaging element 284 is configured to operate. In one embodiment, the opening 284 is a circular hole extending through the wall of the cylindrical transducing element 281 at the center of the X-axis (azimuth) and Y-axis (elevation) of the cylindrical transducing element 281. In one embodiment, the imaging element 284 is circular in cross-section and fits within the opening 284.

In one embodiment, first and second removable transducer modules are provided. In one embodiment, both the first and second transducer modules are configured for both ultrasound imaging and ultrasound therapy. In one embodiment, the transducer modules are configured for therapy only. In one embodiment, the imaging transducer can be attached to a grip or handle of the probe. The first and second transducer modules are configured to be interchangeably coupled to the handle. The first transducer module is configured to apply ultrasound therapy to a first treatment area, while the second transducer module is configured to apply ultrasound therapy to a second treatment area. The depth, width, height, position, and/or orientation of the second treatment area can differ from the first treatment area.

Belt therapy using a coated transducer configured to reduce edge effects

In various embodiments, treatment can advantageously be provided with improved precision. Furthermore, if variations are reduced within the treatment area, efficiency, comfort, and safety can be improved. This, in turn, can reduce treatment time and reduce pain experienced by the patient. In some cases, uneven heating in the focal zone can be caused by geometric aspects of the transducer. Inconsistencies in pressure or temperature distribution can be attributed to edge effects, which can result in pressure or temperature spikes around the focal zone of the transducer. Thus, in the presence of edge effects, rather than achieving a uniformly heated segment, the segment is instead divided into many independent hot spots, which may not meet the goal of a more uniform heat distribution in the focal zone. This phenomenon is further exacerbated at the high heating rates associated with elevated acoustic pressures. This is due to the generation of nonlinear harmonics, which are particularly induced in high-pressure areas. Energy at the harmonic frequencies is more easily absorbed than energy at the fundamental frequency. In one embodiment, energy absorption is governed by the following formula:

H＝2*α*f*p ² /Z (1)

Where α is the absorption constant in neper/MHz·cm, f is the frequency in MHz, p is the pressure at that frequency, Z is the acoustic impedance of the tissue, and H is the heating rate in Watts/cm3. In one embodiment, the amount of harmonics generated is proportional to the intensity. FIG23 shows the normalized harmonic pressure across azimuth at the focal depth for one embodiment of a cylindrical element with imaging elements. FIG23 shows the rapid swings in harmonic pressure at this depth, which results in hot spots and uneven heating.

In one embodiment, the method to combat these hot spots and cold spots caused by edge effects is to reduce the average intensity at the depth of focus and/or increase the heating time. These two methods can reduce the amount of nonlinear heating and allow heat to be conducted from the hot spot to the cold area. When the heating time is increased, the thermal conduction of the tissue effectively acts as a low-pass filter for the acoustic intensity distribution. Although these methods may reduce the problem of uneven heating, they may also reduce the positioning of the heating zone and may also increase the treatment time. Therefore, the three performance areas of ultrasound treatment (such as efficacy, comfort and treatment time) are adversely affected. In one embodiment, a more standardized pressure distribution leads to more consistent treatment, so that the temperature increase achieved by heating, coagulation and/or ablation is more predictable and can better ensure that the desired or target temperature curve is obtained in the TTZ 550. In different embodiments, the trace of the edge effect is achieved by using a transducer coated in a specific area.

In one embodiment, the use of a covering or shield can help circumvent these problems so that efficacy, comfort, and treatment time are optimized. Figure 24 shows the harmonic pressure distribution of an embodiment of a shielded aperture or covered element with an imaging transducer. In one embodiment, the covered element is a covered cylindrical element with an imaging element. The variation in harmonic pressure across the treatment line varies by less than 1.5 dB, with the highest intensity located at the center and near the sharp edges at -10 mm and +10 mm. In one embodiment, the covered element design does not require heat to be conducted away from the hot spot because the tissue along the focal line has a uniform temperature increase during absorption. Therefore, the amount of intensity at the focal point can be increased to localize the heating zone and reduce treatment time.

In one embodiment, the coated element is a shielded treatment cylinder. In one embodiment, the coated element also offers benefits outside the intended heating zone. In one embodiment, the boundary between the heated and unheated joints is significantly improved when compared to an uncoated element. Figure 25 shows a comparison of harmonic pressure across azimuth for an embodiment of cylindrical element 280 compared to an embodiment of cylindrical element 600 with a coating at this boundary. Figure 25 shows that, in one embodiment, the potential harmonic pressure is approximately 20 dB lower for the shielded aperture with coated cylindrical element 600, which helps limit the heating zone and maximize comfort. In one embodiment, plated or unplated areas are primarily used to define areas where the piezoelectric material will be polarized or unpolarized. Plated areas define areas that will be polarized or actually mechanically vibrated. In one embodiment, cylindrical element 280 can be uncoated. Furthermore, the uncoated area can be considered uncoated to the extent that it lacks a conductive coating—in some embodiments, the uncoated area can have other types of surface coatings. In one embodiment, the cylindrical element is fully coated. For example, in one embodiment, the first transducer 280 includes a first coated region 287 that completely covers the concave surface 282 of the cylindrical transducer element with the coating and a second coated region 287 that completely covers the convex surface 283 of the cylindrical transducer element with the coating. The second coated transducer 600 includes a first coated region 287 that completely covers the concave surface 282 of the cylindrical transducer element with the coating and at least one second coated region 287 that partially covers the convex surface 283 of the cylindrical transducer element with the coating. As shown in FIG. 27 , the fully coated first transducer 281 demonstrates a peak in focal gain due to edge effects.

Referring to Figures 11A-13B, in one embodiment, a transducer therapy graph is plotted based on theoretical and experimental performance of a cylindrical transducer element 281 coated across its entire concave surface 282 and its entire convex surface 283. In one embodiment, the coating is a metal. In one embodiment, the coating is a conductive metal. In one embodiment, the coating is an electrical conductor. In various embodiments, the coating is plated with one or more of silver, gold, platinum, mercury, copper, or other materials. In one embodiment, the coating comprises fired silver. In one embodiment, the surface is completely coated. In one embodiment, the surface is completely uncoated. In one embodiment, the surface is partially coated and partially uncoated. The gauge pressure is proportional to the thermal heating measurement at a specified depth. The discrete spikes (the pointed areas at the top of the graph) indicate pressure and/or temperature spikes that occur due to geometric edge effects of the cylindrical transducer element 281's geometry. In various embodiments, a coated transducer 600 including one or more coated areas 287 can be used to reduce the spikes or peaks. In one embodiment, the coated area 287 only partially coats the transducer surface. In one embodiment, the coated area 287 does not completely coat the transducer surface.

As shown in FIG26 , in various embodiments, a coated transducer 600 includes a cylindrical transducing element 281 having one or more coated regions 287. In various embodiments, the coated regions 287 coat a portion, a part, and/or the entire surface of the transducer 600. In various embodiments, the coated regions 287 coat a portion or the entire surface of the cylindrical transducing element 281. In various embodiments, the coated transducer 600 includes one or more imaging elements 284. In some embodiments, one, two, three, or more imaging elements are placed in an "unused area" of the coating/shroud for imaging.

Due to the additional edge of the opening 285, the edge effect caused by the geometry of one embodiment of a combined imaging and cylindrical therapeutic transducer comprising a cylindrical transducer element 281 having an opening 285 therethrough is more pronounced. FIG27 is a graph illustrating the focal gain across the azimuth for two embodiments of a combined imaging and cylindrical therapeutic transducer having different coatings. The first transducer 280 includes a first coated region 287 that completely covers the concave surface 282 of the cylindrical transducer element with a coating, and a second coated region 287 that completely covers the convex surface 283 of the cylindrical transducer element with a coating. Both the first and second coated regions 287 of the first transducer 280 are plated with silver. The second coated transducer 600 includes a first coated region 287 that completely covers the concave surface 282 of the cylindrical transducer element with a coating, and at least a second coated region 287 that partially covers the convex surface 283 of the cylindrical transducer element with a coating. The first and second coated regions 287 of the second transducer 600 are both plated with silver. As shown in FIG. 27 , the fully coated first transducer 281 exhibits a peak in focal gain due to edge effects. The partially coated second transducer 600 has a more consistent, standard performance output in which the peak is substantially reduced and/or eliminated. In various embodiments, the coated transducer 600 reduces the peak so that the variation around the focal depth is reduced by 1-50%, 25-100%, 75-200%, and/or 10-20%, 20-40%, and 60-80%. In various embodiments, the coated transducer 600 reduces the peak so that the variation in intensity at locations around the focal depth is +/- 0.01 to 5 mm, 5 mm or less, 4 mm or less, 3 mm or less, 2 mm or less, 1 mm or less, 0.5 mm or less, 0.25 mm or less, 0.1 mm or less, 0.05 mm or less, or any range therein. In various embodiments, the coated transducer 600 reduces the peak focal gain such that the difference in focal gain is 0.01-0.1, 0.01-1.0, 0.01-5, 0.01-10, 1-10, 1-5, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1 or less, or any range therein.

As described below in Example 2, Figures 28, 29, and 30 illustrate embodiments of the performance of the partially coated second transducer 600 of Figure 27 at various depths. In the illustrated embodiment, the partially coated second transducer 600 has a focal depth of 15 mm. In various embodiments, the focal depth can be at any depth. In various embodiments, the focal depth is at a depth of 7, 8, 9, 10, 12, 13, 13.6, 14, 15, 16, 17, 18, or any depth therein.

In one embodiment, the coated area 287 is electroplated. In one embodiment, the coated area 287 is a conductive material. In one embodiment, the coated area 287 is a semiconductive material. In one embodiment, the coated area 287 is an insulator material. In various embodiments, the coated area 287 is silver, copper, gold, platinum, nickel, chromium, and/or any conductive material that will bond to the surface of the piezoelectric material, or any combination thereof. In one embodiment, the coated area 287 is silver plated.

In various embodiments, the cylindrical transducer element 281 has an azimuthal (x-axis) dimension in the range of 1-50 mm, 5-40 mm, 10-20 mm, 15-25 mm and/or 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, and 25 mm. In various embodiments, the cylindrical transducer element 281 has an elevational (y-axis) dimension in the range of 1-50 mm, 5-40 mm, 10-20 mm, 15-25 mm and/or 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, and 25 mm. In different embodiments, the cylindrical transducer element 281 has a focal depth (z-axis) dimension in the range of 1-50 mm, 5-40 mm, 10-20 mm, 15-25 mm, 12-17 mm, 13-15 mm and/or 10 mm, 11 mm, 12 mm, 13 mm, 13.6 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm and 25 mm. In some non-limiting embodiments, the transducer can be configured for treatment areas at tissue depths of 1.5 mm, 3 mm, 4.5 mm, 6 mm, less than 3 mm, between 1.5 mm and 3 mm, between 1.5 mm and 4.5 mm, greater than 4.5 mm, greater than 6 mm, and anywhere in the range of 0.1 mm-3 mm, 0.1 mm-4.5 mm, 3 mm-7 mm, 3 mm-9 mm, 0.1 mm-25 mm, 0.1 mm-100 mm, and any depth therein below the skin surface.

In various embodiments, the coated transducer 600, including the cylindrical transducer element 281, has one, two, three, four, or more coated regions 287. In one embodiment, the coated regions 287 cover the entire surface of the element. In one embodiment, the coated regions 287 cover a portion of the surface of the element. In various embodiments, the coated regions 287 include a conductive plating. In one embodiment, the coated regions 287 include silver plating to form electrodes. When an electrical signal is applied to the electrodes at the coated regions 287, the coated regions 287 cause the corresponding portion of the cylindrical transducer element 281 to expand and/or contract. In various embodiments, the coated regions 287 have a shape or boundary that is a full or partial point, edge, line, curve, radius, circle, ellipse, parabola, star, triangle, square, rectangle, pentagon, polygon, combinations thereof, or other shapes. In various embodiments, the coated transducer 600 may also include an opening 285.

31 , a partially coated transducer 600 including a cylindrical transducing element 281 has one, two, three, four, or more coated regions 287 having one or more shapes on a convex surface 283. In one embodiment, a partially coated transducer 600 including a cylindrical transducing element 281 has one, two, three, four, or more coated regions 287 having one or more shapes on a concave surface 282. In various embodiments, the coated regions 287 have side edges 293, side edges 290, and a medial edge 291. The various edges can be straight, curved, and/or have radii, and the dimensions can be modified to achieve various performance profiles.

32 , a partially coated transducer 600 including a cylindrical transducing element 281 has one, two, three, four, or more circular, spherical, curved, and/or elliptical coated regions 287. In various embodiments, the coated regions 287 have side edges 293, side edges 290, and a medial edge 291. The various edges can be straight, curved, and/or have a radius, and the dimensions can be modified to achieve various performance profiles.

33 , a partially coated transducer 600 including a cylindrical transducing element 281 has one, two, three, four, or more triangular shaped coated regions 287. In various embodiments, the coated regions 287 have side edges 293, side edges 290, and a medial edge 291. The various edges can be straight, curved, and/or have a radius, and the dimensions can be modified to achieve various performance profiles.

34 , a partially coated transducer 600 including a cylindrical transducing element 281 has one, two, or more square, rectangular, and/or polygonal coated regions 287. In various embodiments, the coated regions 287 have side edges 293, side edges 290, and a medial edge 291. The various edges and/or dimensions can be modified to achieve various performance profiles.

In one embodiment, shown in FIG35 , a partially coated transducer 600 comprising a cylindrical transducing element 281 has one, two, or more coated regions 287 of combined and/or hybrid shapes. In one embodiment, shown in FIG35 , the partially coated transducer 600 is a combined imaging and cylindrical therapeutic transducer comprising a cylindrical transducing element 281 with an opening 285 for an imaging element 284. In one embodiment, the coated transducer 600 comprises a concave surface 282 completely plated with fired silver and a convex surface 283 having two coated regions 287 plated with fired silver to form electrodes. When an electrical signal is applied to the electrodes at the coated regions 287, the coated regions 287 cause the corresponding portions of the cylindrical transducing element 281 to expand and/or contract. In some embodiments, the shape can be applied before or after the polarization process, as vibrations occur at the locations of the electrodes. In different embodiments, the electrodes can be defined before or after polarization. In different embodiments, the coating pattern can be on a concave surface or a convex surface. In one embodiment, there is a coated area 287 having side edges 293, first and second sides 290 and a middle edge 291 having a center edge 297. The individual edges can be straight, curved and/or have a radius. The individual dimensions 294, 295, 296 and the individual edges can be modified to obtain various performance curves. In one embodiment, the middle edge 291 along the curved dimension (elevation) is a portion of an ellipse. In one embodiment, the middle edge 291 along the curved dimension (elevation) is a portion of a parabola. In one embodiment, the first and second sides 290 along the uncurved dimension (azimuth) are a portion of a parabola. In one embodiment, the first and second sides 290 along the uncurved dimension (azimuth) are a portion of an ellipse.

36 , a partially coated transducer 600 including a cylindrical transducing element 281 has one, two, three, four, or more diamond-shaped, rhombus-shaped, and/or other polygonal coated regions 287. In various embodiments, the coated regions 287 have side edges 293, side edges 290, and a medial edge 291. The various edges and/or dimensions can be modified to achieve various performance profiles.

In the embodiment shown in Figures 37 and 38, a partially coated transducer 600 including a cylindrical transducing element 281 has one, two, three, four, or more coated regions 287. In various embodiments, the coated region 287 has a lateral edge 293, a side edge 290, and a medial edge 291. In some embodiments, the coated region 287 is configured to locate one, two, three, four, or more (e.g., multiple) thermal treatment zones via polarization, phase polarization, biphasic polarization, and/or multiphasic polarization. Various embodiments of ultrasound treatment and/or imaging devices having multiple treatment zones achieved via polarization, phase polarization, biphasic polarization, and/or multiphasic polarization are described in U.S. patent application Ser. No. 14/193,234, filed on February 28, 2014, which is incorporated herein by reference in its entirety.

Non-therapeutic uses of coated cylindrical transducers with reduced edge effects

In various embodiments, the coated cylindrical transducer 600 including one or more coated regions 287 is configured for non-therapeutic use.

In one embodiment, the coated cylindrical transducer 600 including one or more coated regions 287 is configured for material processing. In one embodiment, the coated cylindrical transducer 600 including one or more coated regions 287 is configured for ultrasonic impact treatment to enhance the properties of materials (e.g., metals, compounds, polymers, adhesives, liquids, slurries, industrial materials).

In one embodiment, the coated cylindrical transducer 600 including one or more coated regions 287 is configured for material heating. In various embodiments, the cylindrical transducer 600 is configured for cooking, heating, and/or warming materials, foods, adhesives, or other products.

Quantification of tissue heating and thermal dose for ultrasound band therapy

As described above, in various embodiments, the systems and/or methods provide non-invasive dermatological treatment to tissue by heating, hyperthermia, thermal dosimetry, thermotherapy, coagulation, ablation, apoptosis, cytolysis, increasing tissue volume, reducing or decreasing tissue volume, and/or tightening tissue. In one embodiment, skin tissue volume is increased. In one embodiment, adipose tissue volume is reduced or decreased.

In various embodiments, band therapy includes a metric to quantify the amount of adipocyte death using heat. For example, in one embodiment, the thermal dose in thermal therapy is converted to a time-temperature curve relative to a single reference temperature, such as T = 43 degrees Celsius, using the Arrhenius equation. In one embodiment, band therapy is configured such that the rate of cell death doubles for every 1 degree Celsius increase in tissue temperature above body temperature. The theoretical survival rate can then be determined by comparing the thermal dose with empirical data from the literature.

In different embodiments, compared with diathermy or general overall heating technology, band therapy provides improved thermal heating and treatment to tissue.Usually, normal body temperature tends to be in the scope between about 33-37 degrees Celsius.In different embodiments, when tissue is heated in the scope of about 37-43 degrees Celsius, physiological hyperthermia may occur, and being exposed to this temperature range (for example, about a few hours) may cause the increase of normal tissue metabolism and/or normal tissue blood flow to increase, and in some embodiments, accelerated normal tissue repair.When the temperature in tissue reaches the scope higher than 43 degrees Celsius and/or tissue stands the temperature of longer time (for example 2 hours, 3 hours or longer), tissue can experience violent tissue metabolism and/or violent tissue blood flow, and in some embodiments, accelerated normal tissue repair.In one embodiment, tissue is heated (for example, overall heating) to the scope of about 42-55 degrees Celsius. In various embodiments, heating tissue to about 43-50 degrees Celsius can be considered as assisted synergistic hyperthermia, and exposure to this temperature range, for example, for a few minutes, can result in immediate or delayed cell death, apoptosis, decreased tumor metabolism, increased tissue oxygenation, increased tissue damage, increased sensitivity to therapy, vascular status, DNA damage, cell proliferation failure, and/or cell destruction. In various embodiments, heating tissue to about 50-100 degrees Celsius can be considered as surgical hyperthermia, and exposure to this temperature range, for example, for a few seconds or a fraction of a second, can result in coagulation, ablation, vaporization, and immediate cell destruction.

In some embodiments of the present invention, the temperature of the tissue treatment site (e.g., adipocyte) is increased to 38-43 degrees Celsius, and according to one embodiment, tissue metabolism and perfusion are improved and tissue repair mechanisms are accelerated. In other embodiments, the temperature of the tissue treatment site (e.g., adipocyte) is increased to 43-50 degrees Celsius, which, in one embodiment, can increase the cell damage starting point and cause the cell to die immediately, particularly when the temperature remains elevated for approximately a few minutes to an hour (or longer). In other embodiments, the temperature of the tissue treatment site (e.g., adipocyte) is increased to more than 50 degrees Celsius, which, in one embodiment, causes protein coagulation in approximately seconds and less time, and can cause cell death and ablation immediately. In various embodiments, the temperature of the tissue treatment site is heated to 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 70, 75, 80, 90, or 100 degrees Celsius, and/or any range thereof. In various embodiments, the treatment area has a uniform temperature, a variance of 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 12%, 15%, 20%, 25%, 30%, 40%, 50%, or more. In various embodiments, the treatment area has a variance of +/- 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 20, 25 degrees Celsius, or more.

In several embodiments, the present invention comprises increasing the temperature of a tissue treatment site (e.g., adipocytes) to 38-50 degrees Celsius for a period of time between 1-120 minutes, and then optionally increasing the temperature by 10-50% over one, two, three, four, five, or more increments. As an example using three increments, the target temperature can be increased as follows: (i) increasing the temperature to about 40-42 degrees Celsius for 10-30 minutes, (ii) then optionally increasing the temperature by about 20% to bring the temperature to about 48-51 degrees Celsius for 1-10 minutes, and (iii) then optionally increasing by about 10-50% for a shorter time frame. As another example, the target temperature can be increased as follows: (i) raising the temperature to about 50 degrees Celsius for 30 seconds to 5 minutes (e.g., about 1 minute) to destroy greater than 90%, 95%, or 99% of the target (e.g., fat) cells, with an optional preheating step of raising the temperature to 38-49 degrees Celsius for a period of 10-120 minutes before raising the temperature to 50°C. As yet another example, in some embodiments, a non-invasive cosmetic method of heating tissue includes applying a cosmetic heating system to a skin surface, wherein the cosmetic heating system includes a handheld probe, wherein the handheld probe includes a housing enclosing an ultrasonic transducer, the ultrasonic transducer configured to heat tissue beneath the skin surface to a tissue temperature in the range of 40-50 degrees Celsius, wherein the ultrasonic transducer includes a cylindrical transducer element, the cylindrical transducer element including a first surface, a second surface, a coated region, and an uncoated region, wherein the coated region includes an electrical conductor, wherein the first surface includes at least one coated region, wherein the second surface includes an uncoated region and a plurality of coated regions, an electric current is applied to the plurality of coated regions to direct ultrasonic energy into a linear focal zone at a focal depth, wherein the ultrasonic energy produces a reduction in focal gain at the linear focal zone, thereby heating tissue at the focal depth in the linear focal zone to a tissue temperature in the range of 40-50 degrees Celsius for a cosmetic treatment duration of less than 1 hour, thereby reducing the volume of fat tissue in the tissue.

In one embodiment, the band therapy system uses the relationship between cell death and time-temperature dose, as quantified using the Arrhenius equation. The Arrhenius equation shows that there is an exponential relationship between cell death and exposure time and temperature. Above a certain destruction temperature, the increase in the rate of cell killing by temperature is relatively constant. The time-temperature relationship that achieves equivalent doses in several types of tissue appears to be conserved across multiple cell types both in vitro and in vivo.

In some embodiments, clinical scenarios include temperature increases, cooling, and fluctuations as steady-state temperatures are approached and maintained. In various embodiments, different thermal curves can produce the same thermal dose. To estimate the thermal dose based on a time-varying thermal curve, the temperature curve is discretized into small time steps, and the average temperature during each time step is calculated. These temperatures are then integrated according to equation (2), and the thermal dose is calculated as the equivalent exposure time at the destruction temperature (43 degrees Celsius):

Equation (2) shows that the increase in killing rate with temperature is relatively constant. In some embodiments, an increase of 1 degree Celsius above the breaking point results in a doubling of the cell death rate. Figures 39 and 40 show the theoretical cell death ratio over time depending on tissue temperature, with higher theoretical cell kill ratios at higher temperatures and/or longer time periods. The higher the kill ratio (as shown by the kill ratios of 99%, 80%, 50%, 40% and 20%), the higher the temperature and/or time used in the treatment embodiment.

Once the thermal dose is calculated, the dose-survival response can be estimated based on empirical data. In one embodiment, an equivalent dose of 43°C for 100 minutes theoretically produces a 1% cell survival rate. According to embodiments of the present invention, based on the Arrhenius relationship, a similar survival rate can be achieved using an equivalent dose of 44°C for 50 minutes, or 45°C for 25 minutes, as shown in the table in FIG41 , which lists the equivalent doses that theoretically achieve a 1% survival rate.

In different embodiments, simulations of different embodiments of band therapy using cylindrical transducer source conditions associated with the relationship between tissue and thermal equations indicate that successive treatment pulses follow a linear superposition, which allows for simplification of the heat transfer physics such that the heating rate can be described as temperature rise/time (degrees Celsius/second) and as temperature rise/pass (degrees Celsius/button press).

Heating tissue through ultrasound band therapy

In various embodiments, the belt therapy system is configured to treat tissue. For example, in one embodiment, the belt therapy is configured to treat submental fat on the platysma muscle. In one embodiment, treatment of the fat comprises selectively inducing a thermal shock of heat at a depth of approximately 2.5-6.0 mm without causing any major skin surface effects, followed by apoptosis of the fat layer. In one embodiment, the treatment comprises exposing the fat to an overall heating treatment having a temperature duration of 42-55 degrees Celsius for 1-5 minutes without causing any major skin surface effects, which has a physiological/biological effect (e.g., one or more of coagulation, apoptosis, adipocyte dissolution, etc.). In various embodiments, treatment using a belt transducer utilizes an equivalent dose to treat tissue, as shown in the chart of Figure 42, which illustrates theoretical cell kill ratios at various levels.

In various embodiments, a theoretical review of the effects of stacking multiple treatment pulses using the Khokhlov-Zabolotskaya-Kuznetsov (KZK) equation is implemented using a cylindrical source acoustic geometry, which is associated with the bioheat equation (e.g., in one embodiment, using the Arrhenius equation). FIG43 represents the results of a KZK simulation of the output of a cylindrical transducer, which shows the linear superposition of multiple pulses; approximately the same temperature is reached when treating with 3 pulses of 0.45 J or 1 pulse of 1.35 J (3*0.45 J). The results of theoretical experiments of an embodiment of a band therapy system as shown in FIG43 indirectly indicate that nonlinear sound is not a major contributor to the final temperature with respect to energy, and indirectly indicate that body tissue acts as a linear, time-invariant system, which allows the physics of heat transfer to be simplified and the heating and cooling rates to be described with relatively few parameters. In various embodiments, a treatment system having a handle 100 includes a module 200 having one or more ultrasonic transducers 280. In some embodiments, the ultrasonic transducer 280 includes one or more cylindrical ultrasonic elements 281, as shown in Figures 5A-8. The cylindrical transducer element 281 is configured for bulk heating therapy using its linear focus along an axis, resulting in a continuous line that can be moved using an automated motion mechanism to treat a rectangular plane. In one embodiment, the treatment line is positioned in a single direction perpendicular to the direction of motor motion. A single "pass" of treatment produces a number of treatment lines equal to {length}/{spacing}.

In different embodiments, various cylindrical geometries were tested from a first configuration (4.5 MHz - 12 mm width, 4.5 mm and 6.0 mm depth); however, acoustic can testing showed higher acoustic pressures (and thus heating rates) at each edge of the treatment line. In one embodiment, the ceramic transducer was apodized to produce a flat thermal curve, as shown in Figures 44 and 45. In various embodiments, different cylindrical geometries are established based on two operating frequencies, two treatment widths, and two treatment depths: (1) 3.5 MHz - 22 mm width - 4.5 mm depth; (2) 3.5 MHz - 22 mm width - 6.0 mm depth; (3) 4.5 MHz - 22 mm width - 4.5 mm depth; (4) 4.5 MHz - 22 mm width - 6.0 mm depth; (5) 3.5 MHz - 12 mm width - 4.5 mm depth; (6) 4.5 MHz - 12 mm width - 4.5 mm depth; (7) 3.5 MHz - 12 mm width - 6.0 mm depth; and (8) 4.5 MHz - 12 mm width - 6.0 mm depth. In various embodiments, the tissue temperature measurement system includes one or more of infrared thermography, temperature strips, and resistance temperature detectors (RTDs) and thermocouples. Infrared thermography can be used to read the skin surface temperature, the temperature strips can provide the peak temperature reached, and the RTD sheath has a large thermal mass and can have a slow response time. In various embodiments, the thermocouple has a response time of less than 1 second, which is advantageous for measuring the heating and cooling phases of a single treatment. Thermocouples also have the advantage of being small enough so that they can be positioned to the desired tissue depth through a large bore needle. In one embodiment, a specific equivalent dose is connected via a heating phase, followed by a maintenance phase, in which the system or operator pulses the treatment at intervals to maintain a steady-state temperature. The parameter of interest during this phase is the average pulse period required to maintain the steady-state temperature.

Body contouring with ultrasound band therapy

In various embodiments, the belt therapy system is configured for body contouring. In one embodiment, the body contouring treatment comprises a thermal shock concurrent with and/or followed by apoptosis. In one embodiment, the body contouring treatment comprises exposing fat to 42-55 degrees Celsius for 1-5 minutes to induce delayed apoptosis. In one embodiment, the body contouring treatment comprises exposing fat at a focal depth of at least 13 mm below the skin surface.

Temperature and dosage control

In various embodiments, one or more sensors may be included in the module 200 or system 20 to measure temperature. In one embodiment, a method for temperature and/or dose control is provided. In one embodiment, temperature is measured to control the dose of energy provided for tissue treatment. In various embodiments, a temperature sensor is used to measure tissue temperature to increase, decrease, and/or maintain the energy applied to the tissue so as to reach a target temperature or target temperature range. In some embodiments, a temperature sensor is used in a safety device to, for example, reduce or stop applying energy if a threshold or maximum target temperature is reached. In one embodiment, a cooling device or system may be used to cool the tissue temperature if a certain temperature is reached. In some embodiments, a temperature sensor is used to adjust the energy dose, for example, by adjusting or terminating amplitude, power, frequency, pulse, speed, or other factors.

In one embodiment, a temperature sensor is used to measure skin surface temperature. In one embodiment, the temperature sensor can be located on the transducer holder, and the sensor can be located in a portion of the module, or vice versa (swapped). In various embodiments, the temperature sensor is located on the system or module housing, for example, in one embodiment, near or on an acoustic window (e.g., acoustically transparent component 230). In one embodiment, one or more temperature sensors are located around or near acoustically transparent component 230. In one embodiment, one or more temperature sensors are located in or on acoustically transparent component 230. In one embodiment, temperature sensor measurements from the skin surface can be used to calculate the temperature in the tissue at the focal depth of energy application. In various embodiments, the target tissue temperature can be calculated and/or correlated with the depth in the tissue, tissue type (e.g., epidermis, dermis, fat, etc.), and the relative thickness of the tissue between the skin surface and the focal depth. In some embodiments, the temperature sensor provides the temperature measurement as a signal to the control system. In some embodiments, the temperature sensor provides the temperature measurement to the system operator in the form of visual and/or audible feedback, such as text, color, flashing light, sound, beep, warning, alarm, or other sensory indication of the temperature status.

In some embodiments, imaging can be used to control energy dose. In one embodiment, thermal lensing can be used to resolve speckle shift and/or feature shift to indicate tissue temperature at the target location (e.g., at the focal depth in tissue below the skin surface). In one embodiment, acoustic radiation force impulse (ARFI) imaging is used to calculate tissue temperature. In one embodiment, shear wave elastography (SWEI) is used to calculate tissue temperature. In one embodiment, attenuation is used to calculate tissue temperature.

In various embodiments, variable dose delivery techniques are used to achieve and maintain a target temperature in tissue. Body temperature at a depth within the tissue surrounds a thermal treatment zone (TTZ). In one embodiment, to overcome body temperature, the treatment focuses energy into the TTZ at a first rate to bring the tissue temperature within the TTZ to the target temperature. Once the target temperature is reached, a second rate can be reduced or stopped to maintain the tissue at the target temperature.

In some embodiments, energy is focused at a depth or location within the tissue of the TTZ, causing the temperature in the focal zone to increase. However, at the edges of the focal zone (e.g., ends, top, bottom, sides, etc.), the boundary condition of body temperature can cause temperature fluctuations at the boundaries of the treatment zone 552. In various embodiments, movement of the TTZ 550 can be accompanied by the transducer delivering energy to create the treatment zone 552. In one embodiment, the movement mechanism 285 can automatically move the cylindrical transducer element 281 across the surface of the treatment zone so that the TTZ 550 can form the treatment zone 552. In FIG53 , the treatment zone 552 is surrounded or approximately surrounded by body temperature at its edges. In some embodiments, the temperature along the edges/boundaries of the treatment zone 552 is lower than the desired target temperature.

In various embodiments, mechanical speed regulation is used to achieve a specific thermal profile in the treatment area 552. In one embodiment, to achieve a more uniform temperature in the treatment area 552, the temperature applied at the edges/borders is increased to offset surrounding body temperature differences. FIG54 illustrates an embodiment of mechanical speed regulation in which the rate or speed of the automatic motion of the motion mechanism that moves the transducer along direction 290 (in the elevation direction) is varied to provide a more uniform temperature in the treatment area 552 by slowing down near the borders, resulting in increased temperatures at the borders (in one embodiment, at the start and stop locations along a 25 mm travel distance, for example). Increased speed near the middle delivers a lower temperature than decreased speed.

In various embodiments, amplitude modulation is used to achieve a specific thermal profile in the treatment area 552. In one embodiment, to achieve a more uniform temperature in the treatment area 552, the temperature applied at the edges/borders is increased to offset surrounding body temperature differences. FIG55 illustrates an embodiment of amplitude modulation in which the amplitude (related to power) of the energy delivered by the transducer as the automated motion of the motion mechanism moves in direction 290 (along the elevation direction) is varied to provide a more uniform temperature in the treatment area 552 by increasing the amplitude near the borders, resulting in increased temperatures at the borders (in one embodiment, at the start and stop locations along a 25 mm travel distance, for example). The lower amplitude near the middle delivers a lower temperature than the higher amplitude near the borders.

In various embodiments, aperture apodization is used to achieve a specific thermal profile in the treatment region 552. In one embodiment, aperture apodization along a non-focused dimension (e.g., along the TTZ 550 and/or in azimuth) is used to achieve a more uniform temperature in the treatment region 552. The temperature applied at the endpoints along the edges/boundaries is increased to offset surrounding body temperature differences. FIG56 illustrates an embodiment of aperture apodization in which the amplitude of energy delivered by the transducer along the TTZ 550 is varied to provide a more uniform temperature in the treatment region 552 by increasing the amplitude near the endpoints near the boundaries (where L is the length of the focal line TTZ 550 and L/2 from the center is the endpoint) resulting in an increase in temperature at the boundaries. The lower amplitude near the center delivers a lower temperature than the higher amplitude near the boundaries. In various embodiments, a temperature profile along the TTZ can be generated using embodiments of a coated transducing element 600, as shown in FIG31-38.

In various embodiments, the pulse and/or duty cycle are controlled to achieve a specific heat distribution in the treatment area 552. In FIG. 57 , in various embodiments, the treatment pattern can have a uniform or constant pulse or duty cycle. In FIG. 58 , in various embodiments, the treatment pattern can have a variable pulse or a variable duty cycle with variations in any of the peak amplitude, application interval, or application duration. As shown in FIG. 58 , the energy application is longer and covers a larger area near the border of the treatment area 552, while less power is applied to the inner regions for correspondingly lower temperatures.

In various embodiments, a treatment pattern is used to obtain a specific heat distribution in the treatment area 552. In some embodiments, the TTZ 550 has dimensions (e.g., width, height, thickness, etc.). In some embodiments, the pulses of the TTZ 550 are non-overlapping, as shown in FIG59. In some embodiments, the pulses of the TTZ 550 are overlapping, as shown near the boundary in FIG60, where the amount of overlap can be constant or varying. As shown in the embodiment in FIG60, the amount of overlap varies and includes non-overlapping portions. In various embodiments, a cross-hatch pattern is used, where the system head is rotated approximately 90 degrees or orthogonal, and the motion mechanism makes one or more additional passes over the target tissue area in a direction orthogonal to the previous treatment pass.

In various embodiments, the specific thermal profile in the treatment area 552 includes treatment with a tissue temperature of 37-50 degrees Celsius for a duration of several minutes to several hours to induce a target percentage of cell death (e.g., adipocyte death), the relationship of which can be determined by the Arrhenius equation, such as shown on the left side of Figure 61. In various embodiments, the specific thermal profile in the treatment area 552 includes treatment with a tissue temperature exceeding 60 degrees Celsius for a duration of several seconds to a fraction of a second (or nearly instantaneous) to induce coagulation, ablation and/or cell death (e.g., adipocyte death) at high temperatures, as shown on the right side of Figure 62. In various embodiments, treatment can be either sequential and/or simultaneous, or both.

In some embodiments, one, two, three, four, or more of mechanical velocity modulation, amplitude modulation, aperture apodization, pulse duty cycle, and/or treatment at different temperatures can be used to achieve a desired temperature distribution across the treatment region 552. In various embodiments, one or more of mechanical velocity modulation, amplitude modulation, aperture apodization, pulse duty cycle, and/or treatment at different temperatures are used to create a temperature distribution that can include regions for elevated, reduced, and/or uniform temperatures. In some embodiments, one, two, or more types of treatment are applied in one, two, or three dimensions (along any of azimuth, elevation, and/or depth) and are configured for treatment in any of one, two, or three dimensions to create a one-dimensional, two-dimensional, or three-dimensional temperature distribution.

In some embodiments, a composite lens system produces various peak intensities and different depths. In various embodiments, mechanical and/or electronic focusing lenses can be used in any one or more of azimuth, elevation, and/or depth. As shown in Figures 62 and 63, a composite lens system can create two or more focal lines 550 and 550a.

In various embodiments, the ultrasound system 20 includes a motion mechanism 285 configured to move the plurality of ultrasonic transducers 280 and/or the plurality of ultrasonic elements 281. In some embodiments, as shown in the embodiment of FIG64 , the motion mechanism 285 is configured to minimize thermal fluctuations in the treated tissue and reduce treatment time by providing the plurality of elements 281 on a transport system, such as a belt and/or pulley system that can move the plurality of elements 281 at a velocity v. In various embodiments, the velocity can be constant, variable, zero (e.g., stopped), reversible (e.g., forward and backward, left and right, a first direction and a second direction, etc.), and/or have a value within the range of 0-100 RPM, 1 RPM-50 RPM, or other speeds. In various embodiments, the velocity is any value within the range of 1-1000 cm/sec (e.g., 10, 20, 50, 100, 200, 500, 1000 cm/sec, and any other value therein). In various embodiments, the motion mechanism 285 moves one, two, three, four, five, six, seven, eight, or more ultrasonic elements 281. In various embodiments, the ultrasonic elements 281 are connected or spaced apart by a distance of 0.01-10 centimeters (e.g., 0.1, 0.5, 1, 2, 5 centimeters, and any values therein) such that one, two, or more ultrasonic elements 281 are configured to treat a treatment area.

In some embodiments, imaging is used to confirm the quality of the acoustic coupling between the treatment device and the skin. In one embodiment, the clarity of the ultrasound image along the treatment area, line, or point is used to determine the degree of acoustic coupling of the device to the skin surface. In one embodiment, defocused imaging and/or voltage standing wave ratio (VSWR) from backscatter are used to check the acoustic coupling for treatment.

In some embodiments, the treatment is automatic. In one embodiment, the treatment is established by acoustically coupling the system to the skin surface, and the movement mechanism and treatment automatically operate to take effect. In various embodiments, the system is coupled to the skin surface via suction. In various embodiments, the system operator couples the system to the skin surface, activates the system, and can allow the system to automatically perform the treatment or a portion of the treatment. In one embodiment, the system utilizes suction and/or vacuum pressure to hold the probe or a portion of the system to the skin surface, which allows the system user to initiate the treatment and allow the system to automatically perform the treatment or a portion of the treatment for a period of time. In some embodiments, the treatment system includes a TENS stimulation device to reduce pain at the skin treatment site.

Theoretical and experimental treatment with cylindrical transducers

The following examples illustrate various non-limiting embodiments.

Example 1

The following examples are non-limiting embodiments of the present invention.

As shown in FIG11A-20, experiments demonstrated that an embodiment of a transducer 280 including a cylindrical transducer element 281 applied to simulated target tissue, artificial tissue, and porcine tissue samples formed a localized, linear thermal treatment zone (TTZ 550) within a targeted focal region 552. In the experiments, a single cylindrical transducer element 281 was constructed with a radius and focal depth of 15 mm. The dimensions of the cylindrical transducer element 281 were 20 mm (azimuth) by 17 mm (elevation). Additional focal gain can be achieved with a larger aperture. Depth was limited by frequency and focal gain and was set to 6 mm below the simulated tissue surface.

In Figures 11A-13B, treatment curves are plotted based on theoretical and experimental performance achieved with a cylindrical transducer element 281. The standard pressure is proportional to the thermal heating measurement at a specified depth. The spike (the sharp area at the top of the graph) graphically represents the pressure peak that occurs due to geometric edge effects of the geometry of the cylindrical transducer element 281. The spike is visible in both theoretical and experimental performance results. Software simulations reflect the theoretical performance of a 15 mm cylindrical transducer element 281 in Figures 11A, 12A, 13A, 14A, 15A, and 16A. Physical experiments in simulated tissue were conducted and measured, and the results are shown in Figures 11B, 12B, 13B, 14B, 15B, and 16B.

In Figures 11A-11B and 14A-14B, the depth is 20 mm, with the standard pressure peaking at approximately 0.15. As shown in Figures 14A-14B, the standard pressure is not visible. In Figures 12A-12B and 15A-15B, the depth is the optimal designed value of 15 mm, with the standard pressure peaking at approximately 0.8. As shown in Figures 15A-15B, the standard pressure is clearly visible, with the peak standard pressure at approximately 0.9-1.0. The dimensions of the cylindrical transducer element 281 are 20 mm (azimuth) by 17 mm (elevation). The dimensions of the TTZ 550 at a depth of 15 mm are approximately 0.5 mm thick (azimuth) by 17 mm wide (elevation). In Figures 13A-13B and 16A-16B, the depth is 13 mm, with the standard pressure peaking at approximately 0.25. As shown in Figures 16A-16B, the standard pressure is barely visible. As shown by theoretical and experimental data, in the case of a linear TTZ 550, the standard pressure corresponding to the TTZ 550 for a cylindrical transducing element 281 with a focal depth of 15 mm is a depth of 15 mm.

As shown in Figures 17-20, experiments demonstrated that an embodiment of a transducer 280 including a cylindrical transducer element 281 applied to a porcine tissue sample (muscle tissue) formed a localized, linear thermal treatment zone (TTZ 550) within a targeted focal area 552. In the experiment, an embodiment of a transducer 280 including a cylindrical transducer element 281 was passed over porcine muscle tissue three times over 20 seconds, operating at 4.5 MHz and a tissue depth of 6 mm. As shown in Figure 17, these three passes (illustrated by three spikes in temperature) increased the temperature of the porcine muscle. Two power levels are shown. At 40 W, the porcine muscle started at 30 degrees Celsius and reached a maximum temperature of approximately 55 degrees Celsius during the 20-second heating process (between the 20 and 40 second marks) of three passes of the cylindrical transducer element 281 over the target tissue area, then gradually cooled to approximately 32 degrees Celsius 100 seconds after the start of treatment. At 60W, the porcine muscle started at approximately 24 degrees Celsius and reached a maximum temperature of approximately 59 degrees Celsius during three 20-second heating passes of the cylindrical transducer element 281 over the target tissue area (between the 40 and 60 second marks), and then gradually cooled to approximately 40 degrees Celsius 80 seconds after the start of treatment.

FIG18 is a photograph of a treated porcine muscle demonstrating both linear and planar heating. In one embodiment, coagulation depends on the idle time between lines, the idle time between passes, and the number of passes. The temperature rise is slower than the thermal coagulation point. FIG19 is a cross-section through the porcine muscle of FIG18 illustrating the linear thermal treatment zone. FIG20 is an orthogonal cross-section through the porcine muscle of FIG19 illustrating the planar thermal treatment zone.

Example 2

The following examples are non-limiting embodiments of the present invention.

As shown in Figures 28-30, experiments have demonstrated that an embodiment of a partially coated transducer 600 comprising a cylindrical transducer element 281 applied to simulated target tissue forms a localized, linear thermal treatment zone (TTZ 550) within the targeted focal zone 552. The partially coated transducer 600 includes a first coated region 287 that completely covers the concave surface 282 of the cylindrical transducer element with a coating, and at least one second coated region 287 that partially covers the convex surface 283 of the cylindrical transducer element with a coating. Both the first and second coated regions 287 of the partially coated transducer 600 are plated with silver. In the experiments, a single cylindrical transducer element 281 was constructed with a radius and a focal depth of 15 mm. The dimensions of the cylindrical transducer element 281 were 20 mm (azimuth) by 17 mm (elevation). The cylindrical transducer element 281 had an opening 285 with a diameter of 4 mm at its center.

In Figures 28, 29, and 30, treatment profiles are plotted based on theoretical performance achieved with a cylindrical transducer element 281. Theoretical performance is proportional to thermal heating at a specified depth. Software simulations reflect the theoretical performance of a 15 mm partially coated transducer 600, showing a consistent linear thermal treatment zone 550 at a depth of 15 mm.

Example 3

The following examples are non-limiting embodiments of the present invention.

Multiple in vivo porcine studies and multiple cadaveric studies were conducted to evaluate different embodiments of the hardware for whole body heating therapy. Early studies focused on specifying and improving the instrumentation required to measure subcutaneous temperature. In some embodiments, insulated wire thermocouples were placed at focal and subfocal depths by snaking the thermocouples through holes drilled with a needle in the skin and verifying the depth using a Siemens s2000 ultrasound device. Temperature profiles were collected using a high sampling DAQ card. Once the measurement settings were determined, a replicated 3-factor 3 level experimental design was performed in an in vivo porcine model to determine the energy settings that could safely achieve an equivalent dose without causing skin surface damage. In one embodiment, an average temperature difference of 10 degrees Celsius was observed with an average focal heating rate of ~1.2 degrees Celsius per pass. The safe heating rate appeared to be similar across the transducer.

After determining a safe heating rate, a thermal dose study was conducted in an in vivo porcine model. The study demonstrated that embodiments of the system were able to achieve equivalent doses, such as 47 degrees Celsius for 3 minutes, 48 degrees Celsius for 1 minute, and 50 degrees Celsius for 1 minute, without exceeding 41 degrees Celsius on the skin surface. In some embodiments, treatments using higher temperatures and shorter exposure times may have the potential to exceed the target temperature and potentially overheat the skin surface. In various embodiments, the longer it takes to perform the equivalent dose, the greater the heat diffusion to surrounding tissue, and the less selective the treatment becomes with depth. Additionally, the longer the equivalent exposure time, the more impractical the treatment becomes from an operator and ergonomics perspective. For these reasons, in some embodiments, it is preferred to use higher equivalent temperatures and shorter exposure times.

In vivo testing was performed in pigs to determine whether candidate treatment settings for the submental area would cause adverse surface skin effects. The animals obtained for these studies were light-skinned, 120-140 pound castrated male Yucatan miniature pigs, selected because their skin properties were similar to those of human tissue. Skin surface data was evaluated by monitoring the evidence of erythema, edema, and contusion on the skin surface of the animals after treatment. Photos of each treatment area were taken before and after treatment (Cannon G9 and Cannon VIXIA HF 510). In one embodiment, a thermal dose study using a cylindrical element transducer was performed in a pig in vivo model. In several embodiments, the test site was able to achieve a significant temperature difference between the focal tissue site and the skin surface without causing damage to the skin surface. Figure 46 shows the temperature curve of an embodiment from a pig in vivo model treatment, in which the temperature curve reached 50 degrees Celsius for a few seconds, while the skin surface did not exceed 41 degrees Celsius, and showed a temperature difference of up to 15 degrees Celsius between the focal tissue site and the skin surface. The temperature change produced by a single-pass treatment is sufficiently small (approximately 0.9 degrees Celsius per pass or 0.13 degrees Celsius per second) to enforce corrective action and maintain the target temperature within +/- 1 degree Celsius. A modified 3-factor, 3-level design of experiments was performed in a porcine in vivo model to determine the range of energy settings that could safely achieve the equivalent dose temperatures shown in FIG. 42 . According to various embodiments, the settings are listed in the table of FIG. 47 . The design of experiments (DOE) tested acoustic powers ranging from 10-20 W, exposure times ranging from 20-40 ms, and spacing ranging from 0.1-0.3 mm. FIG. 48 shows an embodiment of treatment settings that can achieve a relatively high thermal dose at the focal point with little to no dose or temperature increase at the skin surface. The focal point achieved a thermal dose of 100 equivalent minutes at T = 43 degrees Celsius on the 24th pass (red dashed line), which corresponds to a theoretical survival rate of 1% according to FIG. 42 . In various embodiments, similar temperature increases and heating rates were achieved at the focal point and the surface in various embodiments of the transducer for treatment that does not cause significant skin surface damage. With an average focal heating rate of ∼1.2°C/pass, an average temperature difference of 10°C was observed. The maximum temperature difference between the focal point and the skin was achieved with the 3.5 MHz, 22 mm width, 6.0 mm depth design, which had an average difference of 12°C during treatment. Since the heating rates that produced little to no surface effect were similar across the transducers, the 3.5 MHz, 22 mm width, 6.0 mm depth transducer was selected for evaluation in the thermal dose study.

In different embodiments, thermal dose research is carried out in pig body and corpse model, to determine the geometric form of safe equivalent dose and fat cell death by histological evaluation. The table of Figure 49 has been listed the target time-temperature that is exposed in order to realize fat cell death of different levels. According to the empirical data among Figure 42, position 2 and 5 should reach little or no fat cell death. Position 3, 6 and 7 should reach height fat cell death. Position 1 and 4 should reach moderate fat cell death in the transition zone. The table of Figure 50 has been listed the energy setting that is used to utilize 3.5MHz, 22mm width, 6.0mm depth transducer to approach each equivalent dose. In different embodiments, treatment continues for 2-3 minutes, and pulse is 20-30, with 1 degree Celsius/over and then always maintain the mode of pulse 3-5 seconds to reach target temperature. Several test positions have shown slight surface effect on the treatment day, only become more obvious when damage rises to skin surface. Figure 51 shows a position, for the purpose of tissue coagulation used in histological control and by excessive dose, this position is carried out aggressive treatment. In the embodiment of FIG51 , the size of the lesion, representing an example of the spread of thermal energy, measured 12.6×19.9 mm on the skin surface, with edema detectable up to 12 mm deep from the skin surface. FIG52 shows a visual representation of the time-temperature targets listed in the table of FIG49 (triangle marks), with six equivalent doses obtained in the laboratory shown on FIG52 (square marks). Two of these equivalent doses fall within the coagulation region, two fall within the transition region, and two fall within the hyperthermia region.

Some embodiments and examples described in this application are exemplary, and are not restrictive when describing the full scope of the combination and method of these inventions (plurality). Within the scope of the embodiment of the application, equivalent changes, modifications and variations of some embodiments, materials, compositions and methods can be made. In different embodiments, device or method can combine the features or characteristics of any embodiment disclosed in this application.

While the present invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and described in detail herein. However, it should be understood that the invention is not limited to the specific forms or methods disclosed, but rather, the invention covers all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any method disclosed herein does not have to be performed in the order recited. The methods disclosed herein include certain actions taken by the practitioner; however, they may also, explicitly or implicitly, include any third-party instructions for those actions. For example, an action such as "coupling an ultrasound probe to the skin surface" includes "instructing the ultrasound probe to be coupled to the skin surface." Ranges disclosed herein also encompass any and all overlaps, subranges, and combinations thereof. Language such as "up to," "at least," "greater than," "less than," and "between" includes the recited numbers. Numbers preceded by terms such as "about" or "approximately" include the recited numbers. For example, "about 25 mm" includes "25 mm." When used herein, the terms "approximately," "about," and "substantially" represent an amount or property that approximates the claimed amount or property, while still performing the desired function or achieving the desired result. For example, the terms "about," "approximately," and "substantially" may refer to amounts that are within 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated amount or feature.

Claims (23)

1. An ultrasonic transducer system, comprising: An ultrasonic transducer comprising a cylindrical transducer element; and A power supply configured to drive the cylindrical transducer element. The cylindrical transducer element is configured to apply ultrasonic energy to a linear focusing region at the focal depth. The cylindrical transducer element includes a first surface and a second surface. The first surface includes a conductive coating that completely covers the first surface. The second surface includes two conductive coated areas and at least one uncoated conductive area. The two coated regions on the second surface comprise conductive material, which forms an electrode when the power source is electrically connected to at least one coated region. The conductive material comprises any one or more of the following: silver, copper, gold, and chromium; Wherein, the coated area on the second surface covers at least 60% of the second surface; The coated area on the second surface includes a side edge, a middle edge, a first side edge, and a second side edge. The two coated regions on the second surface are configured to reduce edge noise at the linear focusing region at the focal depth. Specifically, reducing edge noise reduces any one of the following groups: Peak values, thereby reducing the difference around the focal depth by 75-200%. Peak value, thus making the intensity difference around the focal depth 5mm or less, and The difference in focus gain reduces the difference in focus gain to the range of 0.01-10. 2. The ultrasonic transducer system of claim 1, further comprising one or more imaging elements, wherein the cylindrical transducer element has an opening configured to house the one or more imaging elements. The cylindrical transducer element is housed within a handheld ultrasonic probe, which includes: case, The cylindrical transducer element, and Sports organizations; The ultrasonic transducer is movable within the housing. The motion mechanism is attached to the ultrasonic transducer and configured to move the ultrasonic transducer along a linear path within the housing. The conductive material mentioned is silver. The first surface is a concave surface, and the second surface is a convex surface. 3. The ultrasonic transducer system according to claim 1, wherein the first surface is a concave surface and the second surface is a convex surface. 4. The ultrasonic transducer system according to claim 1, wherein the first surface is a convex surface and the second surface is a concave surface. 5. The ultrasonic transducer system according to claim 1, wherein the cylindrical transducer element is housed within an ultrasonic handheld probe, wherein the ultrasonic handheld probe comprises: case, The cylindrical transducer element, and Sports organizations; The ultrasonic transducer is movable within the housing. The motion mechanism is attached to the ultrasonic transducer and configured to move the ultrasonic transducer along a linear path within the housing. 6. The ultrasound transducer system of claim 5, wherein the motion mechanism automatically moves the cylindrical transducer element to heat the treatment area at the focal depth to a temperature in the range of 40-65 degrees Celsius. 7. The ultrasound transducer system according to any one of claims 1-6, wherein the reduction of edge noise contributes to the generation of a uniform temperature in the treatment area. 8. The ultrasound transducer system according to any one of claims 1-6, wherein reduction of edge noise contributes to effective and consistent treatment of the tissue, wherein the cylindrical transducer element is configured to apply ultrasound treatment to a treatment area at a focal depth in the tissue. 9. The ultrasonic transducer system according to any one of claims 1-6, wherein the power supply is configured to drive the cylindrical transducer element to generate a temperature in the tissue at the focal depth in the range of 42-55 degrees Celsius. 10. The ultrasonic transducer system of claim 2 or 5 further includes a temperature sensor located on the housing, the temperature sensor being adjacent to an acoustic window in the housing and configured to measure the temperature of the skin surface. 11. The ultrasonic transducer system according to any one of claims 1 and 3-6, further comprising one or more imaging elements, wherein the cylindrical transducer element has an opening configured to house the one or more imaging elements. 12. The ultrasound transducer system of claim 11, wherein the imaging element is configured to confirm the level of acoustic coupling between the system and the skin surface. 13. The ultrasound transducer system of claim 11, wherein the imaging element is configured to determine the level of acoustic coupling between the system and the skin surface via any one of the group consisting of: defocus imaging and voltage standing wave ratio (VSWR). 14. The ultrasound transducer system of claim 11, wherein the imaging element is configured to measure the temperature of target tissue at the focal depth below the skin surface. 15. The ultrasound transducer system of claim 11, wherein the imaging element is configured to measure the temperature of a target tissue at a focal depth below the skin surface using any one of the group consisting of acoustic radiation force pulse (ARFI), shear wave elastography (SWEI), and attenuation measurement. 16. A method of using a cylindrical ultrasonic transducer for non-therapeutic purposes, comprising: A cylindrical transducer element is provided, comprising a first surface, a second surface, a coated region, and an uncoated region. The coated area includes an electrical conductor. The first surface includes at least one coated area. The second surface includes the uncoated area and a plurality of coated areas. Wherein, the coated area on the second surface covers at least 60% of the second surface; The coated area on the second surface includes a side edge, a middle edge, a first side edge, and a second side edge. An electric current is applied to the coated region, thereby guiding the ultrasonic energy to a linear focusing region at the focal depth. The ultrasonic energy in the linear focusing region causes a decrease in focal gain. Wherein, the reduction in focus gain causes any one of the following items to decrease: Peak values, thereby reducing the difference around the focal depth by 75-200%. Peak value, thus making the intensity difference around the focal depth 5mm or less, and The difference in focus gain reduces the difference in focus gain to the range of 0.01-10. 17. The method of claim 16, wherein the reduction in focus gain reduces the peak value, thereby reducing the difference around the focus depth by 25-100%. 18. The method of claim 16, wherein the reduction in focus gain reduces the peak value, thereby reducing the intensity difference around the focus depth to 5 mm or less. 19. The method of claim 16, wherein the reduction in focus gain reduces the difference in focus gain to a range of 0.01-10. 20. The method of claim 16, wherein the electrical conductor is a metal. 21. The method of claim 16, wherein the first surface is a concave surface and the second surface is a convex surface. 22. The method of claim 16, wherein the first surface is a convex surface and the second surface is a concave surface. 23. The method of claim 16, wherein the cylindrical transducer is housed within a handheld ultrasonic probe, wherein the handheld ultrasonic probe comprises: case, Cylindrical transducer element, and Sports organizations; The ultrasonic transducer is movable within the housing. The motion mechanism is attached to the ultrasonic transducer and configured to move the ultrasonic transducer along a linear path within the housing.