Systems and methods for high resolution ultrasound imaging artifact reduction

Abstract

Improved resolution for high-speed ultrasound imaging of tissues associated with aesthetic and / or cosmetic treatment of skin and / or tissues near the skin. In one embodiment, the high-resolution ultrasound imaging uses dynamic focal zone blending to reduce the appearance of acoustic window multipath echo artifacts. In one embodiment, the high-resolution ultrasound imaging uses an offset between a first imaging frame in a first direction and a second imaging frame in a second direction to reduce temporal motion artifacts. In some embodiments, the imaging system is used in conjunction with aesthetic and / or cosmetic skin treatments.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Application No. 63 / 476,319, filed December 20, 2022, which is incorporated herein by reference in its entirety. Any and all priority claims or amendments thereto identified in the Application Data Sheet are incorporated herein by reference under 37 CFR 1.57.

[0002] Field Some embodiments of the present invention relate to improving high-resolution, fast-moving ultrasound imaging of tissue associated with aesthetic and / or cosmetic treatment of skin and / or tissues near the skin. In one embodiment, high-resolution ultrasound imaging uses dynamic focal zone blending to reduce the appearance of acoustic window multipath echo artifacts resulting from high frame rates and / or fast motion of the ultrasound imaging transducer. In one embodiment, high-resolution ultrasound imaging uses an offset between a first imaging frame in a first direction and a second imaging frame in a second direction to reduce temporal motion artifacts. [Background technology]

[0003] Conventional ultrasound imaging typically uses a single focal zone with a stationary ultrasound imaging transducer. Summary of the Invention

[0004] To rapidly, efficiently, and accurately image tissue for aesthetic and / or cosmetic treatment of the skin and / or tissues beneath the skin, there is a need for improved resolution in offset ultrasound imaging using multiple focal zones at high speed. In various embodiments, an ultrasound system is configured to image to visualize the tissue (e.g., the epidermis, dermis, and / or subcutaneous layers of the tissue). In various embodiments, the ultrasound system is configured to image to visualize the tissue (e.g., the epidermis, dermis, and / or subcutaneous layers of the tissue) and to confirm the appropriate depth for an associated cosmetic or medical treatment, such as avoiding certain tissues (e.g., nerves, bones).

[0005] In various embodiments, systems and methods for ultrasound imaging of tissue are adapted and / or configured to use one or more focal zones within the tissue for imaging. In one embodiment, one single focal zone is used for imaging. In various embodiments, two, three, four, or more focal zones are used for imaging. In various embodiments, an imaging ultrasound transducer is placed in direct acoustically coupled contact with tissue, such as the skin surface, to image one or more focal zones below the skin surface. In various embodiments, the imaging ultrasound transducer has an offset gap between the imaging transducer and a portion of a housing (e.g., a portion at a window, such as a PEEK window) within the ultrasound probe, whereby the portion of the housing is placed in acoustically coupled contact with tissue, such as the skin surface, to image one or more focal zones below the skin surface. In some embodiments, an imaging ultrasound transducer using two or more (e.g., 2, 3, 4, 5, 6, or more) focal zones that may generate multipath artifacts from acoustic ultrasound energy bouncing between the imaging transducer and (i) the acoustic window and / or (ii) the region being imaged has an offset gap between the imaging transducer and a portion of the housing. These artifacts can obscure the clarity of the imaging. In various embodiments described herein, the systems and methods reduce and / or eliminate such artifacts.

[0006] In various embodiments, ultrasound imaging is used to visualize tissue regions and / or anatomical structures, hi one embodiment, ultrasound imaging is used to confirm sufficient acoustic coupling into a tissue region to improve imaging correlation between first and second directional movement of an ultrasound imaging transducer when forming an image.

[0007] In various embodiments, ultrasound imaging is used in conjunction with a cosmetic or medical procedure to visualize, plan, and / or monitor the cosmetic or medical procedure. In one embodiment, ultrasound imaging is used in conjunction with the application of energy to tissue. In one embodiment, ultrasound imaging is used in conjunction with the application of ultrasound therapy to tissue. In one embodiment, ultrasound imaging is used in conjunction with the application of a dermal filler to tissue. In one embodiment, ultrasound imaging is used in conjunction with the application of a drug or compound to tissue. In one embodiment, ultrasound imaging is used in conjunction with the application of botulinum toxin to tissue.

[0008] In some embodiments, systems and methods are provided that successfully achieve aesthetic effects using targeted, precise ultrasound to produce visible, effective cosmetic results via thermal pathways by splitting an ultrasound treatment beam into two, three, four, or more confocal zones to perform various treatment and / or imaging procedures. In various embodiments, an ultrasound system is configured to focus ultrasound to generate localized mechanical motion within tissue and cells to generate localized heating for tissue coagulation or mechanical cell membrane disruption intended for non-invasive aesthetic use. In various embodiments, an ultrasound system is configured to lift brows (e.g., eyebrows). In various embodiments, an ultrasound system is configured to lift loose tissue, such as submental (under the chin) and neck tissue. In various embodiments, an ultrasound system is configured to improve décolleté lines and wrinkles. In various embodiments, an ultrasound system is configured to reduce fat. In various embodiments, an ultrasound system is configured to reduce the appearance of cellulite.

[0009] In some embodiments disclosed herein, the non-invasive ultrasound system is adapted for use in achieving one or more of the following beneficial aesthetic and / or cosmetic improvement effects: face lift, brow lift, chin lift, eye treatment (e.g., treatment of pterygium bags, infraorbital laxity), wrinkle reduction, fat reduction (e.g., treatment of fat and / or cellulite), cellulite (which may be referred to as gynoid lipodystrophy) treatment (e.g., dimpled or non-dimpled female gynoid lipodystrophy), décolleté improvement (e.g., upper chest), buttock lift (e.g., buttocks tightening), skin tightening (e.g., treating laxity and tightening the face or body, such as the face, neck, chest, arms, thighs, abdomen, buttocks), scar reduction, burn treatment, tattoo removal, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, acne treatment, and breakout reduction.

[0010] Some embodiments are particularly advantageous because they include one, some, or all of the following advantages: (i) faster imaging times; (ii) higher imaging resolution; (iii) elimination of obscuring artifacts from imaging; (iv) clear imaging from a moving imaging transducer; (v) more efficient imaging; and / or (vi) improved imaging to support an associated procedure or treatment.

[0011] In some embodiments, an ultrasound imaging system configured to reduce imaging artifacts includes an ultrasound probe, the ultrasound imaging transducer adapted to image a tissue region; a housing including an acoustic window; a dynamic offset distance between the ultrasound imaging transducer and the acoustic window, the dynamic offset distance varying over time, the dynamic offset distance comprising a first offset distance and a second offset distance, the first offset distance being different from the second offset distance; an acoustic coupling medium within the housing configured to acoustically couple the ultrasound imaging transducer to the acoustic window; and a movement mechanism for moving the ultrasound imaging transducer in a first direction and a second direction, wherein the ultrasound imaging transducer changes a focal zone sequence order (f,...,f) when moving in the first direction. N ), where N>2 and the ultrasound imaging transducer is imaged in a second focal zone sequence order (f1,...,f N and a control module coupled to the ultrasound probe for controlling the ultrasound imaging transducer, the control module configured to reduce at least one multipath echo artifact with a dynamically set pulse repetition interval.

[0012] In one embodiment, the dynamically set pulse repetition interval is further configured to measure a first offset depth, calculate a first offset time based on the first offset depth, multiply the first offset time by an integer to determine the presence of at least one multipath echo artifact, and select a pulse repetition interval configured to position the at least one multipath echo artifact outside the displayed ultrasound image.

[0013] In some embodiments, an ultrasound imaging system configured to reduce imaging artifacts includes an ultrasound probe, the ultrasound imaging transducer adapted to image a tissue region; a housing including an acoustic window; a dynamic offset distance between the ultrasound imaging transducer and the acoustic window, the dynamic offset distance varying over time, the dynamic offset distance comprising a first offset distance and a second offset distance, the first offset distance being different from the second offset distance; an acoustic coupling medium within the housing configured to acoustically couple the ultrasound imaging transducer to the acoustic window; and a movement mechanism for moving the ultrasound imaging transducer in a first direction and a second direction, wherein the ultrasound imaging transducer changes a focal zone sequence order (f,...,f) when moving in the first direction. N ), where N>2 and the ultrasound imaging transducer is imaged in a second focal zone sequence order (f1,...,f N and a control module coupled to the ultrasound probe for controlling the ultrasound imaging transducer, the control module configured to reduce at least one multipath echo artifact with one or more dynamically set focal zone blend points.

[0014] In one embodiment, the at least one dynamically set focal zone blend point is further configured to: measure a first offset depth; calculate a first offset time based on the first offset depth; multiply the first offset time by an integer to determine the presence of at least one multipath echo artifact; and select at least one focal zone blend point configured to position the at least one multipath echo artifact outside the displayed ultrasound image. In one embodiment, the dynamic offset distance changes based on a changing volume of the acoustic coupling medium, the changing volume of the acoustic coupling medium being a result of evaporation or leakage of the acoustic coupling medium from the housing. In one embodiment, the dynamic offset distance changes based on a changing temperature of the acoustic coupling medium. In one embodiment, the dynamic offset distance changes based on a changing pressure of the acoustic coupling medium. In one embodiment, the dynamic offset distance changes with the speed of the moving mechanism in at least one of the first direction and the second direction. In one embodiment, the device further includes a therapy transducer configured to apply ultrasound therapy to tissue. In one embodiment, N=2, 3, or 4.

[0015] In some embodiments, an ultrasound imaging system configured to reduce imaging artifacts includes an ultrasound probe, the ultrasound probe including an ultrasound imaging transducer adapted to image a tissue region; a housing including an acoustic window; a dynamic offset distance between the ultrasound imaging transducer and the acoustic window, the dynamic offset distance varying over time, the dynamic offset distance including a first offset distance and a second offset distance, the first offset distance being different from the second offset distance; and means for moving the ultrasound imaging transducer in a first direction and a second direction; and a control module coupled to the ultrasound probe for controlling the ultrasound imaging transducer, the control module configured to reduce at least one multipath echo artifact with a dynamically set pulse repetition interval.

[0016] In some embodiments, an ultrasound imaging module configured to reduce imaging artifacts includes an ultrasound imaging transducer adapted to image a tissue region; a housing including an acoustic window; a dynamic offset distance between the ultrasound imaging transducer and the acoustic window, the dynamic offset distance varying over time, the dynamic offset distance including a first offset distance and a second offset distance, the first offset distance being different from the second offset distance; means for moving the ultrasound imaging transducer in a first direction and a second direction; and a control module coupled to the ultrasound probe to control the ultrasound imaging transducer, wherein the control module is configured to reduce at least one multipath echo artifact with a dynamically set pulse repetition interval.

[0017] In one embodiment, the at least one dynamically set focal zone blend point is further configured to measure a first offset depth, calculate a first offset time based on the first offset depth, multiply the first offset time by an integer to determine the presence of at least one multipath echo artifact, and select at least one focal zone blend point configured to position the at least one multipath echo artifact outside the displayed ultrasound image.

[0018] In some embodiments, an ultrasound imaging device configured to reduce imaging artifacts includes an ultrasound module including an ultrasound imaging transducer adapted to image a tissue region, a housing including an acoustic window, a dynamic offset distance between the ultrasound imaging transducer and the acoustic window, the dynamic offset distance varying over time, the dynamic offset distance including a first offset distance and a second offset distance, the first offset distance being different from the second offset distance, and means for moving the ultrasound imaging transducer in a first direction and a second direction; and a control module coupled to the ultrasound probe for controlling the ultrasound imaging transducer, the control module configured to reduce at least one multipath echo artifact with a dynamically set pulse repetition interval.

[0019] In one embodiment, the at least one dynamically set focal zone blend point is further configured to: measure a first offset depth; calculate a first offset time based on the first offset depth; multiply the first offset time by an integer to determine the presence of at least one multipath echo artifact; and select at least one focal zone blend point configured to position the at least one multipath echo artifact outside the generated ultrasound image. In one embodiment, the dynamic offset distance varies based on a changing volume of the acoustic coupling medium, the changing volume of the acoustic coupling medium being a result of evaporation or leakage of the acoustic coupling medium from the housing. In one embodiment, the dynamic offset distance varies based on a changing temperature of the acoustic coupling medium. In one embodiment, the dynamic offset distance varies based on a changing pressure of the acoustic coupling medium. In one embodiment, the dynamic offset distance varies with the velocity of the mechanism in at least one of the first direction and the second direction. In one embodiment, the device further includes a therapy transducer configured to apply ultrasound therapy to tissue. In one embodiment, N=2, 3, or 4.

[0020] In some embodiments, a method for reducing multipath echo artifacts from an ultrasound image includes providing an ultrasound probe, the ultrasound probe including: an ultrasound imaging transducer adapted to image a tissue region; a housing including an acoustic window; a dynamic offset distance between the ultrasound imaging transducer and the acoustic window, the dynamic offset distance varying over time, the dynamic offset distance comprising a first offset distance and a second offset distance, the first offset distance being different from the second offset distance; an acoustic coupling medium within the housing configured to acoustically couple the ultrasound imaging transducer to the acoustic window; and a movement mechanism for moving the ultrasound imaging transducer in a first direction and a second direction, wherein the ultrasound imaging transducer changes a focal zone sequence order (f,...,f) when moving in the first direction. N ), where N>2 and the ultrasound imaging transducer is imaged in a second focal zone sequence order (f1,...,f N ), measuring a first offset depth, calculating a first offset time based on the first offset depth, multiplying the first offset time by an integer to determine the presence of at least one multipath echo artifact, and selecting a pulse repetition interval configured to position the at least one multipath echo artifact outside the displayed ultrasound image.

[0021] In some embodiments, a method for reducing multipath echo artifacts from an ultrasound image includes providing an ultrasound probe, the ultrasound probe including: an ultrasound imaging transducer adapted to image a tissue region; a housing including an acoustic window; a dynamic offset distance between the ultrasound imaging transducer and the acoustic window, the dynamic offset distance varying over time, the dynamic offset distance including a first offset distance and a second offset distance, the first offset distance being different from the second offset distance; an acoustic coupling medium within the housing configured to acoustically couple the ultrasound imaging transducer to the acoustic window; and a movement mechanism for moving the ultrasound imaging transducer in a first direction and a second direction; calculating a first offset time based on the first offset depth; multiplying the first offset time by an integer to determine the presence of at least one multipath echo artifact; and selecting at least one focal zone blend point configured to position the at least one multipath echo artifact outside the displayed ultrasound image.

[0022] In one embodiment, the method further comprises imaging the tissue and displaying the tissue. In one embodiment, the method further comprises imaging the tissue and displaying the tissue without treating the tissue. In one embodiment, the method further comprises treating the tissue.

[0023] In some embodiments, a method for improving ultrasound imaging alignment by reducing spatial and temporal motion artifacts includes providing an ultrasound probe, the ultrasound probe including an ultrasound imaging transducer adapted to image a tissue region, and a movement mechanism attached to the ultrasound imaging transducer, wherein the ultrasound imaging transducer moves in a first direction to change a focal zone sequence order (f1,...,f2). N), where N>2, and the ultrasound imaging transducer captures a first image in a second focal zone sequence order (f,...,f) as it moves in a second direction. N ), acquiring a first imaging frame, acquiring a second imaging frame, calculating an offset between the first imaging frame and the second imaging frame to determine a lateral displacement, displaying the first imaging frame, and displaying the second imaging frame with an offset applied to reduce temporal motion artifacts.

[0024] In one embodiment, the method further includes calculating an optimized image using at least one trigger offset and applying the at least one trigger offset to subsequent image acquisitions, wherein lateral misalignment is reduced due to application of the at least one trigger offset.

[0025] In some embodiments, a method for improving ultrasound imaging alignment by reducing spatial and temporal motion artifacts includes providing an ultrasound probe, the ultrasound probe including an ultrasound imaging transducer adapted to image a tissue region, and a movement mechanism attached to the ultrasound imaging transducer, wherein the ultrasound imaging transducer moves in a first direction to change a focal zone sequence order (f1,...,f2). N ), where N>2, and the ultrasound imaging transducer captures a first image in a second focal zone sequence order (f,...,f) as it moves in a second direction. N ), acquiring a plurality (N>1) of imaging frames, calculating a temporal average of the at least two imaging frames, and displaying the temporal average of the at least two imaging frames to reduce temporal motion artifacts.

[0026] In one embodiment, the method further includes calculating an optimized image using at least one trigger offset and applying the at least one trigger offset to subsequent image acquisitions, wherein averaging of N>1 consecutive imaging frames is enabled when a spatial misalignment between a current imaging frame and a previously acquired imaging frame is less than a predetermined threshold.

[0027] In some embodiments, a method for improving ultrasound imaging alignment by reducing spatial and temporal motion artifacts includes providing an ultrasound probe, the ultrasound probe including an ultrasound imaging transducer adapted to image a tissue region, and a movement mechanism attached to the ultrasound imaging transducer, wherein the ultrasound imaging transducer moves in a first direction to change a focal zone sequence order (f1,...,f2). N ), where N>2, and the ultrasound imaging transducer captures a first image in a second focal zone sequence order (f,...,f) as it moves in a second direction. N ), acquiring a first imaging frame, acquiring a second imaging frame, calculating an offset between the first imaging frame and the second imaging frame to determine a lateral displacement, calculating a temporal average for the first imaging frame and the second imaging frame, and displaying the temporal average of the first imaging frame and the offset for the second imaging frame to reduce spatial and temporal motion artifacts.

[0028] In one embodiment, the method further includes calculating an optimized image using at least one trigger offset and applying the at least one trigger offset to the optimized image, wherein lateral misalignment is reduced due to application of the at least one trigger offset. In one embodiment, the method further includes imaging the tissue and displaying the tissue. In one embodiment, the method further includes imaging the tissue and displaying the tissue without treating the tissue. In one embodiment, the method further includes treating the tissue.

[0029] In some embodiments, an ultrasound imaging system configured to reduce imaging misalignment includes an ultrasound probe including an ultrasound therapy transducer adapted to administer ultrasound therapy to tissue, an ultrasound imaging transducer adapted to image the tissue, and a movement mechanism for moving the ultrasound imaging transducer in a first direction and a second direction, wherein the ultrasound imaging transducer is mechanically attached to the movement mechanism, the first direction being opposite to the second direction, and wherein the ultrasound imaging transducer moves in a focal zone sequence order (f,...,f) when moving in the first direction. N ), where N>1 and the ultrasound imaging transducer is imaged in a second focal zone sequence order (f1,...,f N ), and the spatial registration between the first and second direction imaging is improved by shifting the trigger position, and the ultrasound imaging system performs direction-dependent focal zone sequencing (f,...,f) on successive A-lines. N ) and (f1,...,f N ), and a control module coupled to the ultrasound probe for controlling the ultrasound imaging transducer.

[0030] In one embodiment, N=2, 4, 6, and 8. In one embodiment, the first direction of transducer movement is any one or more of the group consisting of linear, rotational, and curved, and the second direction is a reverse path of the first direction. In one embodiment, the ultrasound treatment is at least one of a face lift, a brow lift, a chin lift, an eye treatment, wrinkle reduction, décolleté improvement, a butt lift, scar reduction, burn treatment, skin tightening, vascular reduction, sweat gland treatment, sun spot removal, fat treatment, cellulite treatment, vaginal revitalization, acne treatment, and abdominal relaxation treatment.

[0031] It should be understood that while the methods summarized above and described in more detail below describe particular actions taken by a practitioner, they may also include direction of those actions by other parties. Thus, an action such as "moving an imaging transducer" includes "directing movement of an imaging transducer."

[0032] In some embodiments, the system includes various features that exist as a single feature (rather than multiple features). In alternative embodiments, multiple features or components are provided. In various embodiments, the system includes, consists essentially of, or consists of one, two, three, or more embodiments of any feature or component disclosed herein. In some embodiments, a feature or component is not included and may be negatively excluded from a particular claim, such that the system is absent of such feature or component. In some embodiments, a method is performed without a step. In some embodiments, the system does not include a particular component. Further areas of applicability may become apparent from the description provided herein. It should be understood that the description and specific examples are for illustrative purposes only and are not intended to limit the scope of the embodiments disclosed herein. [Brief explanation of the drawings]

[0033] The drawings described herein are for illustrative purposes only and are not intended to limit the scope of the present disclosure in any way. Embodiments may be more fully understood from the detailed description and accompanying drawings. Features from one drawing may be applicable to other drawings in some embodiments.

[0034] [Figure 1A] FIG. 1 is a schematic diagram of an ultrasound system according to various embodiments.

[0035] [Figure 1B] FIG. 1 is a schematic diagram of an ultrasound system according to various embodiments.

[0036] [Figure 1C] FIG. 1 is a schematic diagram of an ultrasound system according to various embodiments.

[0037] [Figure 2] FIG. 1 is a schematic diagram of an ultrasound system coupled to a region of interest according to various embodiments.

[0038] [Figure 3] FIG. 1 is a schematic diagram of an imaging diagnostic ultrasound system according to various embodiments.

[0039] [Figure 4] 1A-1C are schematic diagrams of bidirectional imaging at the same lateral position according to various embodiments.

[0040] [Figure 5] 1 is a schematic diagram of directionally dependent focal zone sequencing according to various embodiments. FIG.

[0041] [Figure 6] 1A-1C are schematic diagrams of directionally dependent focal zone sequencing with different trigger positions according to various embodiments.

[0042] [Figure 7] 1A-1C are schematic diagrams of direction-dependent focal zone sequencing on successive A-lines according to various embodiments.

[0043] [Figure 8A] 1 is a graph of the generation of multipath echo artifacts over time according to various embodiments. [Figure 8B] 1 is a schematic image of the generation of multipath echo artifacts over time according to various embodiments.

[0044] [Figure 9A] 10 is a graph illustrating the use of a static wait time to reduce or eliminate multipath echo artifacts according to various embodiments. [Figure 9B] 1 is a schematic image of using a static wait time to reduce or eliminate multipath echo artifacts according to various embodiments.

[0045] [Figure 10A] 10 is a graph of the generation of multipath echo artifacts with dynamic or varying offset gaps according to various embodiments. [Figure 10B] 10A-10C are schematic images of the generation of multipath echo artifacts with dynamic or varying offset gaps according to various embodiments.

[0046] [Figure 11] 1 illustrates a method for reducing or eliminating artifacts in time-varying dynamic offsets according to various embodiments.

[0047] [Figure 12A] FIG. 1 is a schematic diagram of multiple focal zone imaging producing artifacts in one or more focal zones according to one embodiment.

[0048] [Figure 12B] FIG. 1 is a schematic diagram of multiple blended focal zone imaging to reduce or eliminate the appearance of artifacts in one or more focal zones according to one embodiment.

[0049] [Figure 13]10 illustrates a method for determining an entry image trigger offset to improve lateral imaging alignment registration accuracy according to various embodiments.

[0050] [Figure 14] 1 is a captured image of unstable pixel vibration according to various embodiments.

[0051] [Figure 15A] 10 is a quantified temporal motion artifact with primarily lateral shifts according to various embodiments.

[0052] [Figure 15B] 1 is a diagram illustrating temporally stable quantified temporal motion artifacts according to various embodiments.

[0053] [Figure 15C] 1 is a quantified depth-uniform temporal motion artifact according to various embodiments.

[0054] [Figure 16A] 1 is a captured image of a laterally vibrating unstable pixel according to various embodiments.

[0055] [Figure 16B] 1 is a captured image using a shift filter to stabilize the image according to various embodiments.

[0056] [Figure 17A] 10A-10C are captured images of unstable pixels vibrating in elevation according to various embodiments.

[0057] [Figure 17B] 1 is an image captured using a temporal average consecutive frame filter according to various embodiments.

[0058] [Figure 18A] 1 is a captured image of unstable pixel vibration according to various embodiments.

[0059] [Figure 18B] 10A-10C are images captured using shifted data and a temporal average consecutive frame filter according to various embodiments.

[0060] [Figure 19] FIG. 10 illustrates calculated correlation coefficients over time according to various embodiments.

[0061] [Figure 20] FIG. 2 illustrates inter-frame motion estimation according to various embodiments.

[0062] [Figure 21] FIG. 10 illustrates calculated correlation coefficients over time according to various embodiments.

[0063] [Figure 22A] 1 is a captured image of unstable pixel vibration according to various embodiments.

[0064] [Figure 22B] 10A-10C are images captured using shift data and a temporal average consecutive frame filter when no motion is detected according to various embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0065] The following description illustrates exemplary embodiments and is not intended to limit the invention or its teachings, application, or uses. It should be understood that corresponding reference numerals indicate like or corresponding parts and features throughout the drawings. The description of specific examples shown in various embodiments is for illustrative purposes only and is not intended to limit the scope of the invention(s) disclosed herein. Furthermore, the recitation of multiple embodiments having described features is not intended to exclude other embodiments having additional features or other embodiments incorporating different combinations of the described features. Furthermore, features in one embodiment (e.g., one figure) can be combined with the descriptions (and figures) of other embodiments.

[0066] In various embodiments, systems and methods for ultrasound imaging of tissue are adapted and / or configured to use one or more focal zones within the tissue for imaging. In one embodiment, one focal zone is used for imaging. In various embodiments, two, three, four, or more focal zones are used for imaging. In various embodiments, an imaging ultrasound transducer is placed in direct acoustically coupled contact with tissue, such as the skin surface, to image one or more focal zones below the skin surface. In various embodiments, the imaging ultrasound transducer has an offset gap between the imaging transducer and a portion of a housing (e.g., at an acoustically transparent window such as a PEEK window) within the ultrasound probe, whereby the portion of the housing is placed in acoustically coupled contact with tissue, such as the skin surface, to image one or more focal zones below the skin surface. In some embodiments, the imaging ultrasound transducer has an offset gap between the imaging transducer and a portion of the housing that uses two or more (e.g., 2, 3, 4, 5, 6, or more) focal zones, which can generate multipath artifacts from acoustic ultrasound energy bouncing between the imaging transducer and (i) the acoustic window and / or (ii) the region being imaged. These artifacts can obscure the clarity of the imaging. In various embodiments, the systems and methods described herein reduce and / or eliminate such artifacts. In some embodiments, the imaging is stationary (e.g., at least a portion of the tissue and / or device is not moving). In some embodiments, the imaging is moving (e.g., at least a portion of the tissue and / or device is moving).

[0067] In various embodiments, ultrasound imaging is used to visualize tissue regions and / or anatomical structures, hi one embodiment, ultrasound imaging is used to confirm sufficient acoustic coupling into a tissue region to improve imaging correlation between first and second directional movement of an ultrasound imaging transducer when forming an image.

[0068] In various embodiments, ultrasound imaging is used in conjunction with a cosmetic or medical procedure to visualize, plan, and / or monitor the cosmetic or medical procedure. In one embodiment, ultrasound imaging is used in conjunction with the application of energy to tissue. In one embodiment, ultrasound imaging is used in conjunction with the application of ultrasound therapy to tissue. In one embodiment, ultrasound imaging is used in conjunction with the application of a dermal filler to tissue. In one embodiment, ultrasound imaging is used in conjunction with the application of a drug or compound to tissue. In one embodiment, ultrasound imaging is used in conjunction with the application of botulinum toxin to tissue.

[0069] In various embodiments, systems and methods for ultrasound treatment of tissue are adapted and / or configured to provide cosmetic treatments. In some embodiments, devices and methods direct ultrasound therapy to a single focal point or multiple simultaneous focal points. In various embodiments, ultrasound imaging is used to confirm sufficient acoustic coupling to the treatment area to improve performance or provide improved correlation between first and second directional motion when forming images in cosmetic and / or medical treatments. In some embodiments, devices and methods use ultrasound imaging to confirm sufficient acoustic coupling to the treatment area to improve performance and safety when directing ultrasound therapy to a single focal point or multiple simultaneous focal points in cosmetic and / or medical procedures. In some embodiments, improved ultrasound imaging devices and methods provide better correlation between first and second directional motion when forming images. Embodiments of the present invention provide better imaging correlation between a first and second direction of motion (e.g., better correlation between left-travel imaging images and right-travel imaging images). Embodiments of the present invention provide better spatial registration between first and second motion directions (e.g., better correlation between left- and right-traveling imaging images). The improved ultrasound imaging devices and methods provide faster, improved A-line and / or B-mode imaging (e.g., 1.5x, 2x, 3x, 5x faster scan speeds). In various embodiments, tissues below or even at the skin surface, such as the epidermis, dermis, fascia, muscle, fat, and superficial musculo-aponeurotic system ("SMAS"), are non-invasively treated with ultrasound energy. The ultrasound energy can be focused at one or more treatment points and / or areas, or can be unfocused and / or defocused, and applied to regions of interest including at least one of the epidermis, dermis, subcutaneous tissue, fascia, muscle, fat, cellulite, and SMAS to achieve cosmetic and / or therapeutic effects. In various embodiments, the systems and / or methods provide non-invasive dermatological treatment to tissue through thermal treatment, coagulation, ablation, and / or tightening.In some embodiments disclosed herein, non-invasive ultrasound is used to achieve one or more of the following effects: face lift, brow lift, chin lift, eye treatment (e.g., treatment of pterygium bags, suborbital laxity), wrinkle reduction, fat reduction (e.g., treatment of fat and / or cellulite), cellulite treatment (e.g., dimpled or non-dimpled female gynoid lipodystrophy), décolleté improvement (e.g., upper chest), buttock lift (e.g., buttock tightening), skin relaxation treatment (e.g., tissue treatment for tightening or abdominal relaxation), scar reduction, burn treatment, tattoo removal, vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, acne treatment, and pimple removal. In one embodiment, fat reduction is achieved. In various embodiments, reduction or improvement of one or more characteristics (e.g., dimples, nodules, "yellow peel" appearance, etc.) of cellulite (e.g., dimpled or non-dimpled gynoid lipodystrophy) is achieved, for example, by about 10-20%, 20-40%, 40-60%, 60-80% or more (as well as overlapping ranges therein) compared to untreated tissue. In one embodiment, the décolleté is treated. In some embodiments, two, three, or more beneficial effects may be achieved during the same treatment session and may be achieved simultaneously.

[0070] Various embodiments relate to devices or methods for controlling the delivery of energy to tissue. In various embodiments, the various forms of energy can include acoustic, ultrasound, light, laser, radio frequency (RF), microwave, electromagnetic, radiant, thermal, cryogenic, electron beam, photon-based, magnetic, magnetic resonance, and / or other forms of energy. Various embodiments 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 modify the delivery of ultrasound acoustic energy in any treatment, such as, but not limited to, therapeutic ultrasound, diagnostic ultrasound, ultrasonic welding, any application involving mechanical wave coupling to a target, and other treatments. Generally, in therapeutic ultrasound, tissue effects are achieved by concentrating acoustic energy using focusing techniques from an aperture. In some cases, high-intensity focused ultrasound (HIFU) is used for therapeutic purposes in this manner. In one embodiment, the tissue effect produced by the application of therapeutic ultrasound at a specific depth can be referred to as the creation of a thermal coagulation point (TCP). In some embodiments, the zone can include a point. In some embodiments, the zone is a line, a plane, a sphere, an ellipse, a cube, or other one-, two-, or three-dimensional shape. Thermal and / or mechanical ablation of tissue can be achieved non-invasively or remotely through the creation of TCPs at specific locations. In some embodiments, the ultrasonic treatment does not include cavitation and / or shock waves. In some embodiments, the ultrasonic treatment includes cavitation and / or shock waves.

[0071] In one embodiment, the TCPs can be created in a linear or substantially linear, curved or substantially curved zone or sequence, with each individual TCP separated from adjacent TCPs by a treatment distance. In one embodiment, multiple arrays of TCPs can be created within a treatment area. For example, TCPs can be formed along a first sequence and a second sequence separated from the first sequence by a treatment distance. While therapeutic ultrasound treatment can be administered by a sequence of individual TCPs and the creation of individual TCPs in the sequence, it may be desirable to reduce treatment time and the corresponding risk of pain and / or discomfort experienced by the patient. Forming multiple TCPs simultaneously, near simultaneously, or sequentially can reduce treatment time. In some embodiments, creating multiple TCPs can reduce treatment time by 10%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80% or more.

[0072] Various embodiments address potential challenges posed by administering ultrasound therapy. Various embodiments reduce the time required to form a TCP for a desired cosmetic and / or therapeutic treatment at a target tissue for a desired clinical approach. In various embodiments, the target tissue may be, but is not limited to, skin, eyelids, eyelashes, eyebrows, tear troughs, crow's feet, wrinkles, eyes, nose, mouth (e.g., nasolabial folds, perioral wrinkles), tongue, teeth, gums, ears, brain, heart, lungs, ribs, abdomen (e.g., for abdominal relaxation), stomach, liver, kidneys, uterus, breast, vagina, prostate, testes, glands, thyroid, viscera, hair, muscle, bone, ligament, cartilage, fat, fatty lips, adipose tissue, subcutaneous tissue, transplanted tissue, transplanted organs, lymphatic system, tumors, cysts, abscesses, or portions of a nerve, or any combination thereof.

[0073] Various embodiments of ultrasound treatment and / or imaging devices are described in U.S. Patent Application No. 12 / 996,616, published on May 12, 2011 as U.S. Patent Application Publication No. 2011-0112405A1, which is a U.S. national stage application under 35 U.S.C. §371 of International Application No. PCT / US2009 / 046475, filed on June 5, 2009, and published in English on December 10, 2009, each of which is incorporated herein by reference in its entirety. Various embodiments of ultrasound treatment and / or imaging devices are described in U.S. Patent Application No. 14 / 193,234, published on September 11, 2014 as U.S. Patent Application Publication No. 2014 / 0257145, which is incorporated herein by reference in its entirety. Various embodiments of ultrasound treatment and / or imaging devices are described in International Application No. PCT / US17 / 46703, published on February 22, 2018 as WO 2018 / 035012, with national stage U.S. patent application Ser. No. 15 / 562,384, published on May 16, 2019 as U.S. Patent Application Publication No. 2019 / 0142380, each of which is incorporated herein by reference in its entirety. Various embodiments of ultrasound treatment and / or imaging devices are described in International Application No. PCT / US19 / 14617, published on August 1, 2019 as WO 2019 / 147596, with national stage U.S. patent application Ser. No. 16 / 964,914, published on February 11, 2021 as U.S. Patent Application Publication No. 2021 / 0038925, each of which is incorporated herein by reference in its entirety.

[0074] System Overview 1A, 1B, and 1C, various embodiments of ultrasound system 20 include a hand wand (e.g., handpiece) 100, a module (e.g., transducer module, cartridge, probe) 200, and a controller (e.g., console) 300. In some embodiments, console 300 includes a communication system (e.g., Wi-Fi, Bluetooth, modem, etc.) for communicating with other parties, manufacturers, suppliers, service providers, the internet, and / or the cloud. In some embodiments, cart 301 provides mobility and / or location for system 20 and may include wheels, a surface for writing or placing components, and / or compartments 302 (e.g., drawers, bins, shelves, etc.) for storing or organizing components. In some embodiments, the cart has a power source, such as a power connection for a battery, and / or one or more cords for powering and communication (e.g., Ethernet) connections to system 20. In some embodiments, system 20 includes cart 301. In some embodiments, system 20 does not include cart 301. The hand wand 100 can be coupled to the controller 300 by an interface 130, which can be a wired or wireless interface. The interface 130 can be coupled to the hand wand 100 by a connector 145. The distal end of the interface 130 can connect to a controller connector on circuitry 345 (not shown). In one embodiment, the interface 130 can transmit controllable power from the controller 300 to the hand wand 100. In one embodiment, the system 20 has multiple imaging channels (e.g., 2, 4, 6, 8, 10 channels) for ultra-clear HD (high definition) visualization of subcutaneous structures for improved imaging. In one embodiment, the system 20 has multiple treatment channels (e.g., 2, 4, 6, 8, 10 channels) and a precision linear drive motor that doubles treatment accuracy while increasing speed (e.g., 25%, 40%, 50%, 60%, 75%, 100% or more).

[0075] In various embodiments, the controller 300 can be adapted to and / or configured to operate with the hand wand 100 and module 200, and the overall functionality of the ultrasound system 20. In various embodiments, multiple controllers 300, 300′, 300″, etc. can be adapted and / or configured to operate with multiple hand wands 100, 100′, 100″, etc. and / or multiple modules 200, 200′, 200″, etc. The controller 300 can include connection to one or more interactive graphical displays 310 that can include a touchscreen monitor and a graphic user interface (GUI) and allow a user to interact with the ultrasound system 20. In one embodiment, a second, smaller, more mobile display allows a user to more easily position and view the treatment screen. In one embodiment, the second display allows a system user to view the treatment screen (e.g., on a wall, a mobile device, a large screen, a remote screen). In one embodiment, the graphical display 310 includes a touchscreen interface 315 (not shown). In various embodiments, the display 310 sets and displays operating conditions including equipment activation status, treatment parameters, system messages and prompts, and ultrasound images. In various embodiments, the controller 300 can be adapted and / or configured to include, for example, among others, a microprocessor with software and input / output devices, systems and devices for controlling electronic and / or mechanical scanning and / or multiplexing of transducers and / or multiplexing of transducer modules, systems for power supply, systems for monitoring, systems for sensing the spatial position of probes and / or transducers and / or multiplexing of transducer modules, and / or systems for processing user inputs and recording treatment results.In various embodiments, the controller 300 can include a system processor and various analog and / or digital control logic, such as one or more of a microcontroller, microprocessor, field programmable gate array, computer board, and associated components, including firmware and control software, which can interface with user control and interface circuitry, as well as input / output circuitry and systems for communication, display, interface, storage, documentation, and other useful functions. The system software executing on the system process can be adapted and / or configured to control all initialization, timing, level setting, monitoring, safety monitoring, and all other ultrasound system functions to achieve user-defined treatment goals. Additionally, the controller 300 can include various input / output modules, such as switches, buttons, etc., which can also be suitably adapted and / or configured to control the operation of the ultrasound system 20.

[0076] In one embodiment, the hand wand 100 includes one or more finger-activated controllers or switches, such as 150 and 160. In various embodiments, one or more thermal treatment controllers 160 (e.g., switches, buttons) activate and / or stop treatment. In various embodiments, one or more imaging controllers 150 (e.g., switches, buttons) activate and / or stop imaging. In one embodiment, the hand wand 100 can include a removable module 200. In other embodiments, the module 200 can be non-removable. In various embodiments, the module 200 can be mechanically coupled to the hand wand 100 using a latch or coupler 140. In various embodiments, an interface guide 235 or multiple interface guides 235 can be used to assist in coupling the module 200 to the hand wand 100. The module 200 can include one or more ultrasound transducers 280. In some embodiments, the ultrasound transducer 280 includes one or more ultrasound elements. The module 200 can include one or more ultrasound elements. In one embodiment, module 200 includes a bubble trap to reduce air bubbles in the acoustic medium. Hand wand 100 can include an imaging-only module, a treatment-only module, an imaging and treatment module, etc. In various embodiments, ultrasound transducer 280 is movable in one or more directions 290 within module 200. In some embodiments, transducer 280 is connected to a movement mechanism 400. In some embodiments, transducer 280 is not connected to movement mechanism 400. In various embodiments, the movement mechanism includes a zero, one or more bearings, a shaft, a rod, a screw, a lead screw 401, an encoder 402 (e.g., an optical encoder for measuring the position of transducer 280), and a motor 403 (e.g., a step motor) to help ensure accurate and repeatable movement of transducer 280 within module 200. In various embodiments, module 200 can include transducer 280 capable of emitting energy through acoustically transparent member 230.In one embodiment, module 200 has an offset distance 210 between transducer 280 and acoustically transparent member 230. In one embodiment, module 200 has an offset distance 211, which is the distance between transducer 280 and the bottom of the imaging region. In one embodiment, control module 300 can be coupled to hand wand 100 via interface 130, and graphic user interface 310 can be adapted and / or configured to control module 200. In one embodiment, control module 300 can provide power to hand wand 100. In one embodiment, hand wand 100 can include a power source. In one embodiment, switch 150 can be adapted and / or configured to control tissue imaging functions, and switch 160 can be adapted and / or configured to control tissue treatment functions. In various embodiments, delivery of emitted energy 50 with appropriate focal depth, distribution, timing, and energy level is provided by module 200 through controlled operation by control system 300 of transducer 280 to achieve a desired therapeutic effect in thermal coagulation zone 550.

[0077] In one embodiment, the module 200 can be coupled to the hand wand 100. The module 200 can transmit and receive energy, such as ultrasonic energy. The module 200 can be electronically coupled to the hand wand 100, where such coupling can include an interface that communicates with the controller 300. In one embodiment, the interface guide 235 can be adapted and / or configured to provide electronic communication between the module 200 and the hand wand 100. The module 200 can include various probe and / or transducer configurations. For example, the module 200 can be adapted and / or configured for an integrated dual-mode imaging / therapy transducer, a combined or co-housed imaging / therapy transducer, separate therapy and imaging probes, etc. In one embodiment, when the module 200 is inserted or connected to the hand wand 100, the controller 300 automatically detects it and updates the interactive graphical display 310.

[0078] In some embodiments, an access key 320 (e.g., a secure USB drive, key) is removably connected to system 20 to enable system 20 to function. In various embodiments, the access key is programmed to be customer-specific and provides multiple functions, including system security, country / region-specific access to treatment guidelines and features, software upgrades, support log transfer, and / or credit transfer and / or storage. In various embodiments, system 20 has internet and / or data connectivity. In one embodiment, connectivity provides a method for data to be transferred between the provider of system 20 and the customer. In various embodiments, data includes credits, software updates, and support logs. Connectivity is divided into different model embodiments based on how the user's console is connected to the internet. In one embodiment, a disconnected model connection comprises a console that is disconnected from the internet and where the customer does not have internet access. Credit transfers and software upgrades are performed by shipping an access key (e.g., a USB drive) to the customer. In one embodiment, a semi-connected model connection comprises a console that is disconnected from the internet but where the customer has internet access. Credit transfers, software upgrades, and support log transfers are performed using the customer's personal computer, smartphone, or other computing device in combination with a system access key to transfer data. In one embodiment, the fully connected model connection includes a console wirelessly connected to the internet using wifi, cellular modem, Bluetooth, or other protocols. Credit transfers, software upgrades, and support log transfers are performed directly between the console and the cloud. In various embodiments, system 20 connects to an online portal for streamlined and / or automated inventory management, on-demand treatment purchasing, and business analytics insights to drive customer aesthetic treatment businesses to the next level.

[0079] In various embodiments, tissue below or even at the surface of the skin, such as the epidermis, dermis, subcutaneous tissue, fascia, and superficial musculo-aponeurotic system ("SMAS"), and / or muscle, is non-invasively treated with ultrasound energy. The tissue may also include blood vessels and / or nerves. The ultrasound energy may be focused, unfocused, or defocused and applied to a region of interest, including at least one of the epidermis, dermis, subcutaneous tissue, fascia, and SMAS, to achieve a therapeutic effect. FIG. 2 is a schematic diagram of an ultrasound system 20 coupled to a region of interest 10. In various embodiments, the tissue layer of the region of interest 10 may be in any part of the subject's body. In one embodiment, the tissue layer is in the head and facial region of the subject. A cross-sectional portion of the tissue of the region of interest 10 includes a skin surface 501, an epidermal layer 502, a dermal layer 503, an adipose layer 505, a superficial musculo-aponeurotic system 507 (hereinafter, "SMAS 507"), and a muscle layer 509. The tissue may also include subcutaneous tissue 504, which may include any tissue below the dermal layer 503. The total combination of these layers may be known as subcutaneous tissue 510. Also shown in FIG. 2 is a treatment zone 525 below surface 501. In one embodiment, surface 501 may be the surface of the skin of subject 500. While embodiments relating to treatment at a tissue layer may be used herein as examples, the system may be applied to any tissue within the body. In various embodiments, the system and / or method may be used on tissue including, but not limited to, one or a combination of muscle, fascia, SMAS, dermis, epidermis, fat, adipocytes, cellulite (which may be referred to as gynoid lipodystrophy), collagen, skin, and blood vessels of the face, neck, head, arms, legs, or other locations on or within the body (including body cavities). In various embodiments, reduction of cellulite (e.g., non-dimpled female gynoid lipodystrophy) is achieved in amounts of 2%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 75%, 80%, 90%, 95%, and any range therein.

[0080] Referring to the diagram of FIG. 2 , one embodiment of an ultrasound system 20 includes a hand wand 100, a module 200, and a controller 300. In one embodiment, the module 200 includes a transducer 280. In one embodiment, the ultrasound system 20 has the transducer 280 adapted and / or configured to treat tissue at a focal depth 278. In one embodiment, the focal depth 278 is the distance between the transducer 280 and the target tissue for treatment. In one embodiment, the focal depth 278 is fixed for a given transducer 280. In one embodiment, the focal depth 278 is variable for a given transducer 280. In one embodiment, the transducer 280 is configured to simultaneously treat at multiple depths below the skin surface (e.g., 1.5 mm, 3.0 mm, 4.5 mm, or other depths).

[0081] In one embodiment, module 200 can include a transducer 280 that can emit energy through acoustically transparent member 230. In various embodiments, depth can refer to a focal depth 278. In one embodiment, transducer 280 can have an offset distance 270 that is the distance between transducer 280 and the surface of acoustically transparent member 230. In one embodiment, the focal depth 278 of transducer 280 is a fixed distance from the transducer. In one embodiment, transducer 280 can have a fixed offset distance 270 from the transducer to acoustically transparent member 230. In one embodiment, acoustically transparent member 230 is adapted and / or configured for a position on module 200 or ultrasound system 20 for contacting skin surface 501. In various embodiments, focal depth 278 exceeds offset distance 270 by an amount corresponding to treatment at a target area located at a tissue depth 279 below skin surface 501. In various embodiments, when the ultrasound system 20 is placed in physical contact with the skin surface 501, the tissue depth 279 is the distance between the acoustically transparent member 230 and the target area, measured as the distance from the portion of the surface of the hand wand 100 or module 200 that contacts the skin (with or without acoustic coupling gel, medium, etc.) and the depth within the tissue from that point of skin surface contact to the target area. In one embodiment, the focal depth 278 can correspond to the sum of the tissue depth 279 to the target area below the skin surface 501 plus the offset distance 270 (measured to the surface of the acoustically transparent member 230 in contact with the coupling medium and / or skin 501). In various embodiments, the acoustically transparent member 230 is an acoustic window, such as a PEEK window, configured to transmit ultrasound waves through the coupling medium(s) in the module 200 to the exterior of the acoustically transparent member 230.

[0082] The coupling components can include various substances, materials, and / or devices to facilitate coupling of the transducer 280 or module 200 to the region of interest. For example, the coupling components can include an acoustic coupling system adapted and / or configured for acoustic coupling of ultrasound energy and signals. An acoustic coupling system with possible connections, such as a manifold, can be utilized to couple sound to the region of interest and provide liquid or fluid-filled lens focusing. The coupling system can facilitate such coupling through the use of one or more coupling media, including air, gas, water, liquid, fluid, gel, solid, non-gel, and / or any combination thereof, or any other medium that allows for signal transmission between the transducer 280 and the region of interest. In one embodiment, one or more coupling media are provided inside the transducer. In one embodiment, the fluid-filled module 200 includes one or more coupling media within a housing. In one embodiment, the fluid-filled module 200 contains one or more coupling media within a sealed housing that is separable from the dry portion of the ultrasound device. In various embodiments, the coupling medium is used to transmit ultrasonic energy between one or more devices and tissue with a transmission efficiency of 100%, 99% or more, 98% or more, 95% or more, 90% or more, 80% or more, 75% or more, 60% or more, 50% or more, 40% or more, 30% or more, 25% or more, 20% or more, 10% or more, and / or 5% or more.

[0083] In various embodiments, the transducer 280 can image and treat the region of interest at any suitable tissue depth 279. In one embodiment, the transducer module 280 can provide acoustic power in the range of about 1 W or less, about 1 W to about 100 W, and greater than about 100 W, e.g., 200 W, 300 W, 400 W, 500 W. In one embodiment, the transducer module 280 can provide acoustic power at frequencies of about 1 MHz or less, about 1 MHz to about 10 MHz (e.g., 3 MHz, 4 MHz, 4.5 MHz, 7 MHz, 10 MHz), and greater than about 10 MHz. In one embodiment, the module 200 has a focal depth 278 for treatment at a tissue depth 279 of about 4.5 mm below the skin surface 501. In one embodiment, the module 200 has a focal depth 278 for treatment at a tissue depth 279 of about 3 mm below the skin surface 501. In one embodiment, the module 200 has a focal depth 278 for treatment at a tissue depth 279 of approximately 1.5 mm below the skin surface 501. Some non-limiting embodiments of the transducer 280 or module 200 can be adapted and / or configured to deliver ultrasound energy at tissue depths of 1.5 mm, 3 mm, 4.5 mm, 6 mm, 7 mm, less than 3 mm, between 3 mm and 4.5 mm, between 4.5 mm and 6 mm, greater than 4.5 mm, greater than 6 mm, etc., and anywhere within and at any depth within ranges of 0-3 mm, 0-4.5 mm, 0-6 mm, 0-25 mm, 0-100 mm, etc. In one embodiment, the ultrasound system 20 comprises two or more transducer modules 280. For example, a first transducer module may administer treatment at a first tissue depth (e.g., 4.5 mm), a second transducer module may administer treatment at a second tissue depth (e.g., 3 mm), and a third transducer module may administer treatment at a third tissue depth (e.g., 1.5-2 mm). In one embodiment, at least some or all of the transducer modules may be adapted and / or configured to administer treatment at substantially the same depth.

[0084] In various embodiments, varying the number of focal positions for ultrasound treatment (e.g., having tissue depths 279) can be advantageous because it allows for treatment of the patient at various tissue depths, even if the focal depth 278 of the transducer 270 is fixed. This can provide synergistic results and maximize the clinical outcomes of a single treatment session. For example, treatment at multiple depths below a single surface area allows for a larger overall volume of tissue treatment, resulting in enhanced collagen formation and tightening. Furthermore, treatment at different depths affects different types of tissue, thereby resulting in different clinical effects that improve the overall cosmetic outcome. For example, superficial treatment may reduce the visibility of wrinkles, while deeper treatment may induce the formation of more collagen growth. Similarly, treatment at various locations at the same or different depths can improve treatment.

[0085] While treating a subject at different locations in a single session can be advantageous in some embodiments, sequential treatment over time can be beneficial in other embodiments. For example, a subject can be treated under the same surface area at one depth at time 1, a second depth at time 2, and so on. In various embodiments, the time can be on the order of nanoseconds, microseconds, milliseconds, seconds, minutes, hours, days, weeks, months, or other time periods. New collagen generated by a first treatment is more susceptible to subsequent treatments, which may be desirable for some indications. Alternatively, treating multiple depths under the same surface area in a single session can be advantageous because treatment at one depth can synergistically enhance or complement treatment at another depth (e.g., due to enhanced blood flow, stimulation of growth factors, hormone stimulation, etc.). In some embodiments, different transducer modules provide treatment at different depths. In one embodiment, a single transducer module can be adjusted or controlled for various depths. Safety features to minimize the risk of an incorrect depth being selected can be used in combination with a single-module system.

[0086] In some embodiments, methods are provided for treating the lower face and lower neck area (e.g., submental area). In some embodiments, methods are provided for treating (e.g., softening) the mentolobaric fold. In other embodiments, methods are provided for treating the ocular area (e.g., treating malar fullness, infraorbital laxity). Improved upper lid laxity and periorbital lines and texture are achieved by some embodiments by treating at variable depths. Optimal clinical effects (e.g., softening, tightening) can be achieved by treating various locations in a single treatment session. In some embodiments, the treatment methods described herein are non-invasive cosmetic procedures. In some embodiments, the methods can be used in conjunction with invasive procedures such as surgical facelifts or liposuction where skin tightening is desired. In various embodiments, the methods can be applied to any part of the body.

[0087] In one embodiment, the transducer module 200 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 one, two, or more variable or fixed depths below the dermal layer. In some embodiments, the transducer module includes a movement mechanism adapted and / or configured to induce ultrasound treatment at a series of individual thermal lesions (hereinafter, "thermal coagulation points" or "TCPs") at a constant focal depth. In one embodiment, the sequence of individual TCPs has a treatment interval ranging from about 0.01 mm to about 25 mm (e.g., 1 mm, 1.5 mm, 2 mm, 2, 5 mm, 3 mm, 5 mm, 10 mm, 20 mm, and any range of values ​​therein), and the interval is dithered by 1 to 50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, and any range therein). For example, the spacing can be 1.1 mm or less, 1.5 mm or more, about 1.1 mm to about 1.5 mm, etc. In one embodiment, the individual TCPs are discrete. In one embodiment, the individual TCPs overlap. In one embodiment, the movement mechanism is adapted and / or configured to provide variable spacing between the individual TCPs. In one embodiment, dithering can be adapted and / or configured to provide variable spacing between the individual TCPs. In some embodiments, the transducer module includes a movement mechanism adapted and / or configured to sequentially direct the ultrasonic treatment so that the TCPs are formed in a linear or substantially linear sequence spaced a treatment distance apart. For example, the transducer module can be adapted and / or configured to form the TCPs along a first linear sequence and a second linear sequence spaced a treatment distance apart from the first linear sequence. In one embodiment, the treatment distance between adjacent linear sequences of the individual TCPs is in the range of about 0.01 mm to about 25 mm. In one embodiment, the treatment distance between adjacent linear sequences of the individual TCPs is in the range of about 0.01 mm to about 50 mm. For example, the treatment distance can be 2 mm or less, 3 mm or more, or about 2 mm to about 3 mm.In some embodiments, the transducer module can include one or more movement mechanisms 400 adapted and / or configured to sequentially direct the ultrasonic treatments such that the TCPs are formed in a linear or substantially linear sequence of individual thermal lesions separated from other linear sequences by a treatment distance. In one embodiment, the treatment is applied in a first direction 290 (e.g., pushing). In one embodiment, the treatment is applied in a direction opposite the first direction 290 (e.g., pulling). In one embodiment, the treatment is applied in both the first direction 290 and a direction opposite the first direction (e.g., pushing and pulling). In one embodiment, the treatment distance separating the linear or substantially linear TCP sequences is the same or substantially the same. In one embodiment, the treatment distance separating the linear or substantially linear TCP sequences is different or substantially different for various adjacent pairs of linear TCP sequences.

[0088] In one embodiment, first and second removable transducer modules are provided. In one embodiment, each of the first and second transducer modules is adapted and / or configured for both ultrasound imaging and ultrasound treatment. In one embodiment, a transducer module is adapted and / or configured for treatment only. In one embodiment, the imaging transducer may be attached to a handle of a probe or hand wand. The first and second transducer modules are adapted and / or configured to interchangeably couple to the hand wand. The first transducer module is adapted and / or configured to apply ultrasound treatment to a first layer of tissue, and the second transducer module is adapted and / or configured to apply ultrasound treatment to a second layer of tissue. The second tissue layer is at a different depth than the first tissue layer.

[0089] In various embodiments, delivery of emitted energy 50 at an appropriate focal depth 278, distribution, timing, and energy level is provided by module 200 through controlled operation by control system 300 to achieve the desired therapeutic effect of controlled thermal damage for treating at least one of epidermal layer 502, dermal layer 503, fat layer 505, SMAS layer 507, muscle layer 509, and / or subcutaneous tissue 504. FIG. 3 shows one embodiment of a depth corresponding to a depth for treating muscle. In various embodiments, the depth can correspond to any tissue, tissue layer, skin, epidermis, dermis, subcutaneous tissue, fat, SMAS, muscle, blood vessels, nerves, or other tissue. During operation, module 200 and / or transducer 280 can also be mechanically and / or electronically scanned along surface 501 to treat extended areas. Before, during, and after delivery of ultrasound energy 50 to at least one of the epidermis layer 502, the dermis layer 503, the subcutaneous tissue 504, the fat layer 505, the SMAS layer 507, and / or the muscle layer 509, monitoring of the treatment area and surrounding structures can be provided to plan and evaluate results and / or provide feedback to the controller 300 and the user via the graphical interface 310.

[0090] In one embodiment, the ultrasonic system 20 generates ultrasonic energy that is directed and focused beneath the surface 501. This controlled and focused ultrasonic energy 50 creates a thermal coagulation point or zone (TCP) 550. In one embodiment, the ultrasonic energy 50 creates a void in the subcutaneous tissue 510. In various embodiments, the emitted energy 50 targets tissue beneath the surface 501 and cuts, ablates, coagulates, micro-ablates, manipulates, and / or creates TCPs 550 in the tissue at specific focal depths 278 in the tissue portion 10 beneath the surface 501. In one embodiment, during a treatment sequence, the transducer 280 moves in a direction indicated by the arrows at 290 at specified intervals 295 to form a series of treatment zones 254, each of which receives the emitted energy 50 and forms one or more TCPs 550. In one embodiment, the arrow marked 291 indicates an axis or direction perpendicular to the arrow 290, and the spacing of the TCPs 550 indicates that the TCPs may be spaced perpendicular to the direction of movement of the transducer 280. In some embodiments, the orientation of the spaced apart TCP can be set at any angle between 0 and 180 degrees from arrow 290. In some embodiments, the orientation of the spaced apart TCP can be set at any angle between 0 and 180 degrees based on the orientation of the polarized area on transducer 280.

[0091] In various embodiments, a transducer module can include one or more transducer elements. The transducer elements can include a piezoelectrically active material, such as lead zirconate titanate (PZT), or any other piezoelectrically active material, such as a piezoelectric ceramic, crystal, plastic, and / or composite material, as well as lithium niobate, lead titanate, barium titanate, and / or lead metaniobate. In various embodiments, in addition to or instead of a piezoelectrically active material, the transducer module can include any other material adapted and / or configured to generate radiant and / or acoustic energy. In various embodiments, the transducer modules can be adapted and / or configured to operate at different frequencies and treatment depths. Transducer characteristics include an outer diameter ("OD") and a focal length (F LIn one embodiment, the transducer has an OD=19 mm and F L In other embodiments, the OD and F may be adapted and / or configured to have OD = 15 mm. L Other suitable values ​​of OD, such as less than about 19 mm, more than about 19 mm, and F, such as less than about 15 mm, more than about 15 mm. L can be used. The transducer module can be adapted and / or configured to apply ultrasonic energy at different target tissue depths. As previously described, in some embodiments, the transducer module comprises a movement mechanism adapted and / or configured to direct ultrasonic treatments in a linear or substantially linear sequence of individual TCPs, with a treatment interval between each individual TCP. For example, the treatment interval can be approximately 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, etc. In some embodiments, the transducer module can further comprise a movement mechanism adapted and / or configured to sequentially direct ultrasonic treatments such that the TCPs are formed in a linear or substantially linear sequence separated by treatment intervals. For example, the transducer module can be adapted and / or configured to form TCPs along a first linear sequence and a second linear sequence separated from the first linear sequence by a treatment interval of approximately 2 mm to 3 mm. In one embodiment, a user can manually move the transducer module across the surface of the treatment area to create a contiguous linear sequence of TCPs. In one embodiment, a movement mechanism can automatically move the transducer module across the surface of the treatment area to create a contiguous linear sequence of TCPs.

[0092] Multifocal Zone Sequencing In various embodiments, ultrasound imaging is used in conjunction with therapeutic tissue treatment. Various embodiments for improved ultrasound imaging use multiple focal zones to obtain better signal quality and resolution through depth. For traditional diagnostic ultrasound scanners (linear, curvilinear, phased array, etc.), in which 2D ultrasound images are formed without the need to move the transducer, the sequence in which these multiple focal zones are acquired is relatively unimportant, as the exact placement of these focal zones can be electronically controlled. FIG. 3 illustrates focal zone imaging that does not move during imaging, optionally with an electronically steered / translated aperture. For a non-moving imaging transducer, the positioning of the focal zones is precise, and therefore focal zone sequencing is not used. In a traditional multiple focal zone imaging sequence, the order of focal zone interrogation is different. In various embodiments, the number "N" of focal zone sequences includes 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more focal zones. In one embodiment, N=1 for 1 focal zone. In one embodiment, N=4 for 4 focal zones. In one embodiment, N=8 for 8 focal zones. In the following embodiments, N=4 is used, although various embodiments may use any value of N. For example, when N=4, the four focal zone sequence follows the progression (f1, f2, f3, f4) regardless of the position and direction of motion.

[0093] However, when moving an imaging transducer (e.g., a mechanically translated or steered array), this can be problematic, especially at increased speeds, due to differential positioning of the transducer as it scans multiple focal zones. This misalignment is particularly magnified when imaging is generated bidirectionally (generating both left-right and right-left images), since the interrogation region between the two images may differ. While this principle is demonstrated in the context of linear translation, the present disclosure applies to all types of motion, including, but not limited to, translation, rotation, curvature, two-dimensional and three-dimensional, or any combination thereof.

[0094] The imaging system embodiments disclosed herein address these misalignments. In some cases, spatial misalignment occurs due to the fact that the transducer is moving at one or more speeds during imaging. In particular, extreme focal zones can be located between two images that should examine the same region of interest. When forming a 2D image with a mechanically translated / steered transducer, the transmit / receive position of the transducer changes due to the fact that the transducer is also moving during the propagation time associated with the ultrasound signal.

[0095] In one embodiment, the first direction travel (outbound) sequence proceeds in order (f1, f2, f3, f4), and the second direction travel (return) sequence is (f1, f2, f3, f4) or (f4, f3, f2, f1), which allows for better alignment of the two images. In one embodiment, the right travel (outbound) sequence proceeds in order (f1, f2, f3, f4), and the left travel (return) sequence is also (f1, f2, f3, f4), which allows for better alignment of the two images (FIG. 4). In one embodiment, an alternative sequence is proposed where the right travel (outbound) sequence proceeds in order (f1, f2, f3, f4), and the left travel (return) sequence is reversed (f4, f3, f2, f1), which allows for better alignment of the two images (FIG. 5). In various embodiments, the direction can be left, right, forward, backward, up, down, clockwise or counterclockwise, and / or a combination of rotational and translational motion.

[0096] 4-7 illustrate an embodiment of direction-dependent focal zone sequencing. The left-running sequence can be repeated or reversed relative to the right-running sequence, resulting in improved focal zone alignment. Furthermore, the acquisition can be shifted so that the same region of interest is better aligned between these two images. FIGS. 4-7 illustrate an embodiment of direction-dependent focal zone sequencing using different trigger positions. The spatial alignment between the right-running A-lines and the left-running A-lines is further improved by shifting the trigger positions. In one embodiment, the imaging system uses a novel sequence of two consecutive A-lines following a sequential progression of (line 1: f1, f2, f3, f4; line 2: f1, f2, f3, f4). In one embodiment, the imaging system uses a novel sequence of two consecutive A-lines following a sequential progression of (line 1: f1, f2, f3, f4; line 2: f4, f3, f2, f1). This sequence can be repeated across the entire field of view, and assuming an even number of vectors in the field of view, the return sequence can have the exact same alternating pattern focal zone sequence, and the two images will be aligned.

[0097] FIG. 7 illustrates an embodiment of direction-dependent focus sequencing using an alternating sequence between consecutive A-lines (fl-f2-f3-f4) and (fl-f2-f3-f4) or (f4-f3-f2-fl). In one embodiment, the entire field of view is spanned by an even number of A-lines, and the left- and right-traveling focus sequences are the same. The trigger position still changes between the two images. In various embodiments, multifocal zone imaging provides the advantage of better correlation between the first direction run-formed image and the second direction run-formed image. In various embodiments, multifocal zone imaging provides the advantage of faster scan speeds (e.g., 2x, 3x, 4x) to improve the effectiveness of B-mode imaging. In various embodiments, multifocal zone imaging is applied to any number of focal zones greater than one. In various embodiments, the number of focal zones is 2, 3, 4, 5, 6, 7, 8, 9, 10, or more.

[0098] According to various embodiments, an ultrasound treatment system creates one, two, or more simultaneous therapeutic treatment points and / or focal zones below the skin surface for cosmetic treatment. The acoustic beam movement may be side-to-side, up-down, and / or at an angle. In one mechanical dithering embodiment, the movement of the movement mechanism is fast enough to create a flatter temperature profile around the intended TCP, thereby reducing the total acoustic energy for the same affected tissue volume, reducing the total acoustic energy for a larger affected tissue volume, or a combination thereof. According to various embodiments, frequency modulation alters the location of the focal zones and / or the spacing between them, and electronic dithering of the beam by modulating the frequency precisely changes and / or moves the location of the beam focus. For example, in one embodiment, small frequency swings can be used to dither 1.5 mm apart, + / - 0.1 mm. In various embodiments, the frequency swing can be used to dither any one or more of the following intervals: 0.5, 0.75, 1.0, 1.2, 1.5, 2.0 mm + / - 0.01, 0.05, 0.1, 0.12, 0.15, 0.20, 0.25, 0.30 mm. In various embodiments, the frequency is modulated from 1 to 200% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 100%, 120%, 150%, 180%, 200%, and any range therein).

[0099] According to various embodiments, cosmetic ultrasound treatment systems and / or methods can non-invasively generate one or more dithering cosmetic treatment zones and / or thermal coagulation points, where ultrasound waves are focused at one or more locations within a treatment region in tissue below the skin surface and moved via frequency variation (e.g., via frequency modulation). Some systems and methods provide cosmetic treatment at different locations within tissue, such as at different depths, heights, widths, and / or locations. In one embodiment, the method and system includes a multiple depth / height / width transducer system configured to provide ultrasound treatment to one or more target regions, such as between at least one depth treatment region of interest, a surface target region, and / or a subcutaneous region of interest. In one embodiment, the method and system includes a transducer system configured to provide ultrasound treatment to two or more regions of interest, such as between at least two points at various locations (e.g., at fixed or variable depths, heights, widths, and / or orientations) within the region of interest in tissue. Some embodiments can split the beam to focus into two, three, four, or more focal points (e.g., multiple focal points, multifocal points) for imaging cosmetic treatment zones and / or regions of interest within tissue. The position and / or dithering of the focal points can be positioned axially, laterally, or otherwise within the tissue. Some embodiments can be configured for spatial control, such as by positioning and / or dithering the focal points, varying the distance from the transducer to the reflective surface, and / or varying the angle of energy focused or defocused on the region of interest, and / or for temporal control, such as by controlling the frequency, drive amplitude, and timing of the transducer. In some embodiments, the position and / or dithering of multiple treatment zones or focal points is achieved by poling, phased poling, biphasic poling, and / or multiphasic poling. In some embodiments, the positioning of multiple treatment zones or focal points involves phasing, which in one embodiment is electrical phasing. As a result, changes in the location of the treatment region, the number, shape, size and / or volume of treatment zones or lesions within the region of interest, and thermal conditions can be dynamically controlled over time.

[0100] According to various embodiments, the cosmetic ultrasound treatment system and / or method can create multiple cosmetic treatment zones using one or more of frequency modulation, phase modulation, poling, nonlinear acoustics, and / or Fourier transform to create any spatially periodic pattern with one or more ultrasonic segments. In one embodiment, the system uses poling at the ceramic level to deliver one or more treatment zones simultaneously or sequentially. In one embodiment, the poling pattern is a function of focal depth and frequency, using odd or even functions. In one embodiment, a poling pattern that can be a combination of odd or even functions is applied based on focal depth and / or frequency. In one embodiment, the process can be used in more than one dimension to create any spatially periodic pattern. In one embodiment, the ultrasound beam is split axially and laterally to significantly reduce treatment time through the use of nonlinear acoustics and Fourier transform. In one embodiment, modulation from the system and amplitude modulation from the ceramic or transducer can be used to sequentially or simultaneously place multiple treatment zones within tissue.

[0101] In one embodiment, an aesthetic imaging and treatment system includes an ultrasound probe including an ultrasound transducer configured to deliver ultrasound therapy to tissue at multiple locations in a focal depth using electronic dithering of multiple energy beam apertures with frequency modulation. In one embodiment, the system includes a control module coupled to the ultrasound probe for controlling the ultrasound transducer.

[0102] In one embodiment, the system includes dithering configured to provide variable spacing between a plurality of individual cosmetic treatment zones. In one embodiment, the series of individual cosmetic treatment zones have treatment spacing ranging from about 0.01 mm to about 25 mm (e.g., 1 mm, 1.5 mm, 2 mm, 2, 5 mm, 3 mm, 5 mm, 10 mm, 20 mm, and any range therein), and the spacing is varied by dithering by 1 to 50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, and any range therein). In one embodiment, a series of individual cosmetic treatment zones have treatment spacing ranging from about 0.01 mm to about 100 mm (e.g., 1 mm, 1.5 mm, 2 mm, 2, 5 mm, 3 mm, 5 mm, 10 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm, 100 mm, and any range of values ​​therein), and the spacing is dithered by 1 to 50% (e.g., 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50% and any range therein).

[0103] In one embodiment, the system further includes a movement mechanism configured to be programmed to provide constant or variable spacing between the plurality of individual cosmetic treatment zones. In one embodiment, the series of individual cosmetic treatment zones have a treatment spacing ranging from about 0.01 mm to about 25 mm (e.g., 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 19 mm, or any range or value therein). In one embodiment, the series of individual cosmetic treatment zones have a treatment spacing ranging from about 0.01 mm to about 100 mm (e.g., 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100 mm, or any range or value therein). In one embodiment, the treatment zones are spaced along a distance of about 25 mm. In one embodiment, the treatment zones are spaced along a distance of about 50 mm. In various embodiments, the treatment zone is located along a distance of 5 mm to 100 mm (e.g., 10 mm, 20 mm, 25 mm, 35 mm, 50 mm, 75 mm, 100 mm, and any amount or range therein). In various embodiments, the treatment zone is located along a linear and / or curved distance.

[0104] For example, in some non-limiting embodiments, the transducer can be configured to any tissue depth within the ranges of 0.5 mm, 1.0 mm, 1.5 mm, 2 mm, 3 mm, 4.5 mm, 6 mm, less than 3 mm, 0.5 mm to 5 mm, 1.5 mm to 4.5 mm, greater than 4.5 mm, greater than 6 mm, and 0.1 mm to 3 mm, 0.1 mm to 4.5 mm, 0.1 mm to 25 mm, 0.1 mm to 100 mm, and any depth therein (e.g., 6 mm, 10 mm, 13 mm, 15 mm). In some embodiments, tissue is treated at a depth below the skin surface, and the skin surface is not compromised. Instead, the therapeutic effects achieved at a depth below the skin surface result in a favorable cosmetic appearance of the skin surface. In other embodiments, the skin surface is treated with ultrasound (e.g., at a depth less than 0.5 mm).

[0105] One advantage of the translation mechanism is that it can provide more efficient, accurate, and precise use of ultrasound transducers for imaging and / or therapeutic purposes. One advantage this type of translation mechanism has over a conventional fixed array of multiple transducers fixed in space within a housing is that the fixed array is spaced a fixed distance apart. In one embodiment, the transducer module is configured to provide ultrasonic therapeutic acoustic power in a range of about 1 W to about 100 W (e.g., 3-30 W, 7-30 W, 21-33 W) and a frequency of about 1 MHz to about 10 MHz to thermally heat tissue and induce coagulation. In one embodiment, the transducer module is configured to provide ultrasonic therapeutic acoustic power in a range of about 1 W to about 500 W for peak or average energy (e.g., 3-30 W, 7-30 W, 21-33 W, 100 W, 220 W or more) and a frequency of about 1 MHz to about 10 MHz to thermally heat tissue and induce coagulation. In some embodiments, instantaneous energy is delivered. In some embodiments, an average energy is delivered. In one embodiment, acoustic power can be in the range of 1 W to about 100 W in the frequency range of about 1 MHz to about 12 MHz (e.g., 1 MHz, 3 MHz, 4 MHz, 4.5 MHz, 7 MHz, 10 MHz, 2-12 MHz), or about 10 W to about 50 W in the frequency range of about 3 MHz to about 8 MHz (e.g., 3 MHz, 4 MHz, 4.5 MHz, 7 MHz). In one embodiment, acoustic power can be in the range of 1 W to about 500 W in the frequency range of about 1 MHz to about 12 MHz (e.g., 1 MHz, 4 MHz, 7 MHz, 10 MHz, 2-12 MHz), or about 10 W to about 220 W in the frequency range of about 3 MHz to about 8 MHz, or 3 MHz to 10 MHz. In one embodiment, acoustic power and frequency are about 40 W at about 4.3 MHz and about 30 W at about 7.5 MHz. The acoustic energy generated by this acoustic power can be from about 0.01 Joules ("J") to about 10 J, or from about 2 J to about 5 J. The acoustic energy generated by this acoustic power can be from about 0.01 J to about 60,000 J (e.g., for bulk heating, body shaping, submental fat, abdomen and / or flanks, arms, inner thighs, outer thighs, buttocks, abdominal relaxation, cellulite), about 10 J, or from about 2 J to about 5 J.In one embodiment, the acoustic energy is in the range of less than about 3 J. In various embodiments, the treatment power is 1 kW / cm. 2 ~100kW / cm 2 , 15kW / cm 2 ~75kW / cm 2 , 1kW / cm 2 ~5kW / cm 2 , 500W / cm 2 ~10kW / cm 2 , 3kW / cm 2 ~10kW / cm 2 , 15kW / cm 2 ~50kW / cm 2 , 20kW / cm 2 ~40kW / cm 2 , and / or 15 kW / cm 2 ~35kW / cm 2 is.

[0106] In some embodiments described herein, the procedures are entirely cosmetic and not medical. For example, in one embodiment, the methods described herein do not need to be performed by a physician, but rather at a spa or other aesthetic facility. In some embodiments, the system can be used for non-invasive cosmetic treatment of the skin.

[0107] In various embodiments, the ultrasound treatment is at least one of a face lift, a brow lift, a chin lift, an eye treatment, wrinkle reduction, décolleté improvement, a butt lift, scar reduction, burn treatment, skin tightening (e.g., abdominal fat treatment), vascular reduction, sweat gland treatment, sun spot removal, fat treatment, and cellulite treatment.

[0108] In some embodiments, systems and methods are provided that successfully improve ultrasound imaging of tissue while moving, such as when the imaging transducer is on a moving mechanism. In various embodiments, higher resolution is achieved. In various embodiments, better imaging signal quality is obtained. In various embodiments, ultrasound imaging is used in conjunction with therapeutic tissue treatment.

[0109] In various embodiments, an ultrasonic treatment and imaging system configured to reduce imaging misalignment includes an ultrasonic probe, the ultrasonic probe including an ultrasonic therapy transducer adapted to administer ultrasonic therapy to tissue, an ultrasonic imaging transducer adapted to image the tissue, and a movement mechanism for moving the ultrasonic imaging transducer in a first direction and a second direction. In one embodiment, the ultrasonic imaging transducer is mechanically attached to the movement mechanism. In one embodiment, the first direction is linear. In one embodiment, the second direction is linear. In one embodiment, the first direction is parallel to the second direction. In one embodiment, the first direction is opposite to the second direction. In one embodiment, the ultrasound imaging transducer images in a first focal zone sequence order (e.g., f1, f2, ... fN) when moving in a first direction, and the ultrasound imaging transducer images in a second focal zone sequence order (e.g., f1, f2, ... fN; or fN, ... f2, f1) when moving in a second direction, and spatial alignment between imaging in the first direction and imaging in the second direction is improved by shifting the trigger position. In one embodiment, a control module is coupled to the ultrasound probe to control the ultrasound imaging transducer.

[0110] In various embodiments, an ultrasonic treatment and imaging system configured to reduce imaging misalignment includes an ultrasonic probe including an ultrasonic therapy transducer adapted to administer ultrasonic therapy to tissue, an ultrasonic imaging transducer adapted to image the tissue, and a movement mechanism for moving the ultrasonic imaging transducer in a first direction and a second direction. In one embodiment, the ultrasonic imaging transducer is mechanically attached to the movement mechanism, the first direction is linear, the second direction is linear, the first direction is parallel to the second direction, and the first direction is opposite to the second direction, and the ultrasonic imaging transducer images in a first focal zone sequence order (f1, f2, f3, f4) when moving in the first direction, and the ultrasonic imaging transducer images in a second focal zone sequence order (f1, f2, f3, f4) or (f4, f3, f2, f1) when moving in the second direction. In one embodiment, spatial alignment between imaging in a first direction and imaging in a second direction is improved by staggering trigger positions, and the imaging system uses a sequence of two consecutive A-lines followed by a sequential progression of (line 1: f1, f2, f3, f4; line 2: f1, f2, f3, f4), and a control module is coupled to the ultrasound probe to control the ultrasound imaging transducer. In one embodiment, spatial alignment between imaging in a first direction and imaging in a second direction is improved by staggering trigger positions, and the imaging system uses a sequence of two consecutive A-lines followed by a sequential progression of (line 1: f1, f2, f3, f4; line 2: f4, f3, f2, f1), and a control module is coupled to the ultrasound probe to control the ultrasound imaging transducer.

[0111] In various embodiments, an ultrasound treatment and imaging system configured to reduce imaging misalignment includes an ultrasound probe including an ultrasound therapy transducer adapted to administer ultrasound therapy to tissue, an ultrasound imaging transducer adapted to image the tissue, and a movement mechanism for moving the ultrasound imaging transducer in a first direction and a second direction. In one embodiment, the ultrasound imaging transducer is mechanically attached to the movement mechanism. In one embodiment, the first direction is opposite to the second direction. In one embodiment, the ultrasound imaging transducer images in a focal zone sequence order (f1,...,fN), where N>1, when moving in the first direction. In one embodiment, the ultrasound imaging transducer images in a second focal zone sequence order (f1,....fN) or (fN,...,f1) when moving in the second direction. In one embodiment, spatial alignment between imaging in the first direction and imaging in the second direction is improved by shifting trigger positions. In one embodiment, the imaging system uses direction-dependent focal zone sequencing iteration (f1-...-fN) and (f1-...-fN) and / or alternates between (f1-...-fN) and (fN-...-f1) on successive A-lines, and a control module is coupled to the ultrasound probe to control the ultrasound imaging transducer.

[0112] In one embodiment, the first direction of transducer movement is any one or more of the group consisting of linear, rotational, and curved. In one embodiment, the second direction is a reverse path of the first direction. In one embodiment, the first direction of movement occurs in multiple dimensions, and the second direction is a reverse path of the first direction. In one embodiment, an ultrasound imaging transducer having a first focal zone sequence order is designated as (f1,...,fN), where N>1 (e.g., N is 2, 3, 4, 5, 6, or more). In one embodiment, the ultrasound therapy transducer is configured to treat tissue at a first set of locations disposed within a first cosmetic treatment zone and a second set of locations disposed within a second cosmetic treatment zone, the first zone being different from the second zone. In one embodiment, the ultrasound therapy transducer is adapted to administer ultrasound therapy using amplitude modulation, whereby multiple portions of the ultrasound transducer are adapted to emit ultrasound therapy at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude. In one embodiment, at least a portion of the ultrasound transducer is adapted to emit ultrasound treatment at two or more amplitudes of acoustic intensity, and the amplitude of the ultrasound treatment emitted by at least a portion of the piezoelectric elements varies over time. In one embodiment, the ultrasound transducer includes a piezoelectric material, and multiple portions of the ultrasound transducer are adapted to generate multiple corresponding variations of the piezoelectric material in response to an electric field applied to the ultrasound transducer. In one embodiment, the variations of the multiple piezoelectric materials include at least one of expansion of the piezoelectric material and contraction of the piezoelectric material. In one embodiment, the ultrasound transducer is adapted to deliver ultrasound treatment via a phase shift, whereby the multiple portions of the ultrasound transducer are adapted to emit ultrasound treatment at multiple phases of acoustic intensity, where a first phase is different from a second phase. In one embodiment, the multiple phases include discrete phase values.In one embodiment, the ultrasound transducer is adapted to administer the ultrasound treatment using amplitude modulation, whereby multiple portions of the ultrasound transducer are adapted to emit the ultrasound treatment at multiple amplitudes of acoustic intensity, the first amplitude being different from the second amplitude, and is adapted to administer the ultrasound treatment, whereby multiple portions of the ultrasound transducer are adapted to emit the ultrasound treatment at multiple phases of acoustic intensity, the first phase being different from the second phase. In various embodiments, the ultrasound treatment is at least one of a face lift, a brow lift, a chin lift, an eye treatment, wrinkle reduction, décolleté improvement, a butt lift, scar reduction, burn treatment, skin tightening (e.g., sagging treatment), vascular reduction, sweat gland treatment, sun spot removal, fat treatment, cellulite treatment, vaginal rejuvenation, and acne treatment.

[0113] In various embodiments, a method for reducing imaging misalignment of a moving ultrasound probe includes shifting a trigger position of spatial alignment between imaging in a first direction and imaging in a second direction using an ultrasound probe, the ultrasound probe comprising an ultrasound therapy transducer adapted to administer ultrasound therapy to tissue, an ultrasound imaging transducer adapted to image the tissue, and a movement mechanism for moving the ultrasound imaging transducer in the first direction and the second direction, the ultrasound imaging transducer being mechanically attached to the movement mechanism, the first direction being opposite to the second direction, the ultrasound imaging transducer imaging in a first focal zone sequence order (f1,...,fN) when moving in the first direction, N>1, and the ultrasound imaging transducer imaging in a second focal zone sequence order (f1,...,fN) or (fN,...,f1) when moving in the second direction.

[0114] In one embodiment, N=2, 3, 4, 5, 6, 7, 8, 9, and 10. In one embodiment, N=2. In one embodiment, N=4. In one embodiment, N=6. In one embodiment, N=4. In various embodiments, the ultrasound treatment is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, décolleté improvement, butt lift, scar reduction, burn treatment, tattoo removal, skin tightening (e.g., abdominal relaxant treatment), vein removal, vein reduction, sweat gland treatment, hyperhidrosis treatment, sun spot removal, fat treatment, vaginal revitalization, and acne treatment.

[0115] Minimizing imaging artifacts from acoustic reflections In various embodiments, systems and methods for ultrasound imaging of tissue are adapted and / or configured to use one or more focal zones within the tissue for imaging. In one embodiment, one focal zone is used for imaging. In one embodiment, one focal zone is used for imaging without treatment. In one embodiment, one focal zone is used for imaging with treatment. In various embodiments, two, three, four, or more focal zones are used for imaging. In various embodiments, two, three, four, or more focal zones are used for imaging without treatment. In various embodiments, two, three, four, or more focal zones are used for imaging with treatment. In various embodiments, an imaging ultrasound transducer is placed in direct acoustically coupled contact with tissue, such as the skin surface, to image one or more focal zones below the skin surface. In various embodiments, the imaging ultrasound transducer has an offset gap between the imaging transducer and a portion of a housing (e.g., at an acoustically transparent window such as a PEEK window) within the ultrasound probe, whereby the portion of the housing is placed in acoustically coupled contact with tissue, such as the skin surface, to image one or more focal zones below the skin surface. In some embodiments, an ultrasound transducer for imaging has an offset gap between the imaging transducer and a portion of the housing that uses two or more (e.g., 2, 3, 4, 5, 6, or more) focal zones, which can create multipath artifacts from acoustic ultrasound energy bouncing between the imaging transducer and (i) the acoustic window and / or (ii) the area being imaged. These artifacts may obscure the clarity of the imaging.

[0116] 8A and 8B, in some embodiments, multipath artifacts 810 can be generated when ultrasound energy propagates across an acoustic medium (e.g., acoustic couplant, fluid, gel, liquid such as water, glycerin, saline, and any combination thereof) within the housing of an ultrasound imaging system. In some embodiments, the artifacts are generated in the acoustic medium within an offset gap 800 between the imaging transducer (e.g., imaging array) and the target problem. In some embodiments, this offset gap is 10.9, 11.1, 12.4, or 13.8 mm, but also varies depending on the transducer temperature, the amount of fluid within the transducer, and the pressure (either atmospheric or by the patient or clinician) on the acoustic window. The multipath artifact 810 may be an ultrasound artifact in which the ultrasound beam reflects at an angle that returns only a portion of the ultrasound beam to the transducer. This artifact can be generated from a portion of the acoustic energy that is trapped and bounces off inside the transducer housing between the imaging array and the acoustic window. More specifically, multipath artifacts 810 can be generated from acoustic energy that reflects and bounces repeatedly between the imaging array and the acoustic window. In one embodiment, these reflections can result in multipath artifacts 810 that exist at integer multiples of the distance between the imaging array and the acoustic window. Multipath artifacts 810 can blur and / or obscure the clarity of images generated from the ultrasound imaging system, causing invalid or inefficient interpretation of the generated images.

[0117] In one embodiment, when performing B-mode imaging at a high pulse repetition frequency (“PRF”), such as when acquiring multiple focal zones at depths (e.g., 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, 12 mm below the skin surface, and any ranges and values ​​therein), artifacts may be observed in successive imaging lines. This can produce blurry or unclear images, or images that may result in invalid or inefficient interpretation of the generated images. In one embodiment, multipath artifacts 810 due to imaging transmit at a given A-line / focal zone may be present in image data at subsequent A-lines / focal zones. Therefore, images generated from partially reflected ultrasound beams can also produce multipath artifacts 810 throughout the image, rather than just in one focal zone. This embodiment is shown schematically in FIG. 8A. As shown in FIG. 8A, multipath artifacts 810 may exist from focal zone 1 transmission (Tx1) as a result of ultrasound repeatedly bouncing across offset gap 800 between the imaging array and the acoustic window, and between the imaging array and the bottom of the image at area distance 801. This is represented as the Tx1 dashed line 802 shown in FIG. 8A. Over time, as shown in FIG. 8A, multipath artifacts 810 continue to form from overlapping ultrasound bounces and reflections. Then, when a subsequent focal zone (Tx2), indicated by dotted line 804, is sequenced, reverberations of the multipath artifacts 810 also appear in the imaging data. 8A illustrates this Tx1 dashed line 802 being present during the imaging of the Tx2 dotted line 804 by showing the Tx1 dashed line 802 and the Tx2 dotted line 804 crossing or overlapping. As shown in FIG. 8B, this is the focal zone 2 (Tx2) image 806, in which multipath artifacts 810 are present and partially blur / obscure the image. In some embodiments, the multipath artifacts 810 can limit the imaging rate of the system, as the wait time (or delay) must be set to a long enough period so that the multipath artifact echoes are sufficiently attenuated.In various embodiments, this period may be in the range of 30 to 60 microseconds (μs) (e.g., 30 to 35, 30 to 40, 30 to 45, 30 to 50, 30 to 55, 35 to 40, 40 to 45, 45 to 50, 50 to 55, 55 to 60, 35 to 55, 35 to 50, 35 to 45, 40 to 50, 40 to 55, 40 to 60, 45 to 55, 45 to 60, 50 to 60, 55 to 60 μs), and values ​​and ranges therein.

[0118] 9A and 9B , for an imager-to-acoustic window offset gap distance 900 that remains static or constant, a wait time or pulse repetition interval (PRI) can be strategically selected or calculated to reduce or eliminate multipath artifacts. For example, the wait time interval can be strategically selected so that multipath artifacts present on subsequent focal zone image data (between the imaging array and acoustic window across the offset gap 900, and between the imaging array and the bottom of the imaging field distance 901) are outside the field of view of the transducer. As shown in FIG. 9A , the Tx1 dashed line 902 does not intersect with, but rather is parallel to, Tx2 904. In this embodiment, the multipath artifact 910 (not shown) is outside the field of view of the imaging. Furthermore, as shown in FIG. 9B , the multipath artifact 910 (not shown) echo is not present in the generated Tx2 image 906, but instead is present outside the image acquisition time of Tx2 904. In various embodiments, the static wait time can be in the range of -30 to 60 microseconds (e.g., 30, 32, 32.5, 34, 36, 36.5, 37, 37.5, 38, 39, 39, 5, 40, 42, 44, 44.5, 45, 45.5, 46, 48, 50, 52, 54, 56, 58, 60 and values ​​and ranges therein).

[0119] In some embodiments, the offset gap 1000 between the imaging transducer and the acoustic window varies between 1000-1000' (e.g., the variation is dynamic). The dynamic offset gap 1000, 1000' can change with changes in the temperature, pressure, and / or volume of the coupling medium. The temperature, pressure, and / or volume of the coupling medium can change and fluctuate, thereby deflecting the acoustic window and changing the offset gap distance 1000-1000'. In one embodiment, the housing of the ultrasound system may lose coupling medium through evaporation and / or leakage over time with system use. In one embodiment, the temperature of the coupling medium within the housing of the ultrasound system changes over time. In one embodiment, the pressure of the coupling medium within the housing of the ultrasound system changes over time. In one embodiment, when a user or object presses on the acoustic window, the offset gap 1000, 1000' to the acoustic window can change, thus deflecting the acoustic window and changing the offset gap 1000, 1000'. As shown in one embodiment of Figure 10A, multipath artifacts 1010 from Tx1 appear as a result of sound repeatedly bouncing between the variable offset gap 1000' - 1000' distance between the imaging array and the acoustic window. This is represented by the Tx1 dashed line 1002.

[0120] The calculations for determining timing to reduce imaging artifacts for dynamic offsets are more complex than for static offsets. For static offsets, the timing calculations remain constant. However, for dynamic offsets, the timing calculations change. Using static calculations in a dynamic imaging environment can result in imaging artifacts.

[0121] FIG. 11 shows a flowchart for dynamically setting ultrasound imaging transmit wait times / pulse repetition intervals (PRIs) to reduce imaging multipath artifacts 810, 910, 1010, according to one embodiment. In one embodiment, dynamic wait time calculations are performed by expanding the imaging region to include depths at which acoustic windows may be placed. With these additional depths, dynamic offset distances 1000, 1000' are measured in the B-mode image. The distance is measured by determining the offset depth of the first echo from the acoustic window. The speed of sound in the transducer coupling fluid at a given temperature is determined. The offset depth is calculated in terms of round-trip travel time. Subsequent multipath artifact timing is calculated by taking integer multiples of the round-trip travel time. In some embodiments, if the internal coupling fluid temperature is also monitored, the speed of sound may be a constant value or may be determined as a function of temperature. In some embodiments, the system can then dynamically set the wait time or pulse repetition interval so that a subsequent imaging transmit sequence is performed, and the multipath artifact 1010 is present at a time outside the receive echo sampling interval of the subsequent transmit. In some embodiments, this calculation may be performed for each image frame, A-line, or focal zone transmit. In some embodiments, the focal zone may also be set to any of the intervals.

[0122] 11, a method 1102 for dynamically setting a wait time or pulse repetition interval is shown. In block 1104, the system determines the depth of the first acoustic window echo. This allows the transducer to align the generated ultrasound image to the acoustic window actually being scanned. In block 1106, the system converts the determined depth to time. The conversion is based on the time of flight and the speed of sound in the acoustic medium. In one embodiment, in block 1108, the calculated time is multiplied by an integer to determine the number of times multipath artifacts may be present. In block 1110, a wait time or pulse repetition interval is selected. The selected wait time or pulse repetition interval can place multipath artifacts outside of subsequent image acquisition. This dynamically sets the transmit wait time or pulse repetition interval to eliminate multipath echo artifacts.

[0123] 12A and 12B, in some embodiments, a pulse repetition interval (PRI, in units of time, e.g., 30-60 microseconds, e.g., 30, 32, 32.5, 34, 36, 36.5, 37, 37.5, 38, 39, 39.5, 40, 42, 44, 45, 45.5, 46, 48, 50, 52, 54, 56, 58, 44.5, 60, and values ​​and ranges therein) is selected for an imaging sequence utilizing multiple focal zone imaging. In one embodiment, a static PRI is implemented. In one embodiment, a dynamic PRI is implemented. In one embodiment, a multipath echo artifact 1210 is generated in a specific region within the receive echo sampling interval of the imaging sequence. In one embodiment, the multipath focal zone images are blended into a single image, such that the region of the image containing the artifact 1210 is not selected for display. This can be done when there is enough time between lateral positions for the multiple echo artifacts 1210 to settle. This calculation can be performed for each image frame, A-line, or focal zone transmission. As shown in Figure 12A, the image formed from the first focal zone transmission Fz1 does not contain artifact 1210, but a subsequent focal zone image, for example, Fz2, does contain artifact 1210. However, as shown in Figure 12B, when blending focal zone images to form a single image, the first focal zone image Fz1 is used at a depth where artifact 1210 is present in the other focal zone images Fz2, Fz3, and Fz4.

[0124] In various embodiments, two, three, four, five, six, seven, eight, or more focal zones are used. In some embodiments, four focal zones, Fz1, Fz2, Fz3, and Fz4, are used, as shown in FIGS. 12A and 12B. In one embodiment, the imaging sequence uses sufficient wait time between focal zone 4 from one lateral position to focal zone 1 at the next lateral position. As a result, multipath echo artifacts are present only in focal zones 2 through 4 (Fz2, Fz3, Fz4). The regions of all four focal zone images, separated by dashed black lines in FIGS. 12A and 12B, are blended and combined to form a single combined image. In one embodiment, the blending regions are dynamically set so that multipath artifacts are not present in the final image, as shown in FIG. 12B. As shown in FIG. 12B, the multipath artifacts are effectively cropped from the final image by changing the size of the four squares.

[0125] In one embodiment, calculating the depth at which multi-pass artifacts exist in the image comprises the following steps.

[0126] Let d0 be the depth at which the first echo of the acoustic window is detected in the B-mode image. Assuming constant velocity sound propagation, the time between the initial imaging transmission and the arrival of this echo (t0) is defined as:

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[0127] Therefore, the time it takes for a multipath echo artifact to reach the imaging array (t N ) occurs at integer multiples of t0.

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[0128]

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[0129]

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[0130] Improving imaging alignment In various embodiments, the imaging transducer can move at various speeds across the field of view within the housing with the movement mechanism 400. In one embodiment, the movement mechanism 400 comprises a shaft, rod, screw, or lead screw 401 for precise and repeatable movement of the imaging transducer along a line, e.g., the imaging transducer moves in and out, in and out along the shaft, rod, screw, or lead screw 401. In various embodiments, the imaging transducer can be moved across the field of view at a speed of 0.1 to 10.0 cycles per second (or Hertz, Hz) (e.g., 0.1, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, and 10.0 cycles / second (including any values ​​and ranges therein), e.g., 0.1-1.0, 0.1-2.0, 0.1-3.0, 0.1-4.0, 0.1-5.0, 1.0-2.0, 1.0-3.0, 1.0-4.0, 1.0-5.0, 2.0-3.0, 2.0-4.0, 2.0-5.0 cycles / second). In one embodiment, the imaging transducer moves across the field of view at a constant number of cycles per second. In one embodiment, B-mode images are acquired during both the exit and entry movements of the imaging transducer. Thus, the frame rate can be increased or doubled to twice the constant number of cycles or frames per second. For example, in one embodiment, the imaging transducer moves across the field of view at 3.0 cycles per second. In one embodiment, B-mode images are acquired during both the exit and entry movements of the imaging transducer, and the frame rate is increased or doubled to 6.0 cycles or frames per second. However, in some embodiments, slight misalignment of the spatial interrogation between the entry and exit frames can occur, resulting in an inaccurate image that appears to vibrate. Misalignment can occur in more than one dimension (e.g., up / down, left / right, in / out, x-axis, y-axis, z-axis). Furthermore, in some embodiments, the misalignment can include a rotational component. In various embodiments, this image misalignment may occur in the lateral (eg, side-to-side) and / or elevation (eg, in-out) dimensions.In some embodiments, the result of this image misalignment can be that the image appears shaken or distorted, even when the imaging area is stationary or motionless.

[0131] 13, in some embodiments, lateral imaging misalignment is reduced and / or eliminated by implementing an image trigger offset. In some embodiments, elevation misalignment is addressed by implementing at least one adaptive motion filter.

[0132] In some embodiments, lateral image misalignment is reduced or eliminated using exit and entry frames, where imaging frames may be acquired first for both the exit and entry actions with minimal or zero offset between the two directions. In one embodiment, the image trigger position for both frames may be the same. Then, in some embodiments, a lateral cross-correlation may then be performed on all entry vectors. In one embodiment, the exit frame may be used as a reference to determine which lateral position in the exit frame best matches each entry vector. Furthermore, spatial interpolation may be used to match the vectors to sub-pixel accuracy to better address misalignment within the frames.

[0133] In some embodiments, the exit image frame is considered a reference image. In one embodiment, the imaging transducer moves with the treatment transducer providing treatment in the exit direction. In one embodiment, guide markers in the displayed image indicate the location of the treatment dose.

[0134] In one embodiment, the lateral displacement between the approach vector and the reference exit image may be inverted and subsequently compiled to form a spatial image trigger offset curve for the next approach frame acquisition. In one embodiment, the image trigger offset curve is not physically realizable. This may occur if the image trigger offset causes the time difference between successive lateral position image acquisitions to be shorter than the minimum required imaging time at a single position, overflowing the imaging acquisition data stream and presenting an error message indicating an imaging trigger failure. To address this, in one embodiment, a cost function is formulated to minimize the difference between the ideal acquisition delay and the achievable acquisition delay.

[0135] In some embodiments, the cost function is implemented by seeding each entry position with an absolute offset, combined with applying physical constraints on the module's motion profile and propagating feasible trigger offsets away from the absolute position along the entire lateral range of the module's movement. This generates N feasible trigger offset curves, where N is the total number of lateral positions in the image. A new set of imaging frames is acquired using the optimized feasible entry image trigger offset curves. The exit frames remain unchanged; however, feasible imaging trigger delays may be applied to entry imaging frame acquisitions. Next, in some embodiments, the process can be repeated to calculate a new set of misalignment offsets and further refined entry image trigger delay curves. The process may be repeated until the two images converge and any lateral misalignment is suppressed below a specified predetermined threshold. In some embodiments, once the misalignment is below the threshold, imaging trigger offsets can be programmed into the transducer, and these offsets can be applied to all subsequent entry image acquisitions. In one embodiment, redundant feasible trigger offset curves are eliminated. If one curve intersects with another curve, the two curves are mixed and matched and a cost function is used to eliminate suboptimal curves until a single optimized, feasible trigger offset curve is obtained.

[0136] As shown in FIG. 13 , one embodiment of method 1302 addresses imaging inaccuracies, vibrations, and / or blurring in images due to misalignment between entry and exit frames collected by the system to improve lateral alignment. In block 1304, the system applies a minimum or zero offset to the imaging frames. In block 1306, exit and entry imaging frames are acquired by the system. In block 1308, the lateral misalignment is calculated by the system. In block 1310, the system determines whether the misalignment is below a predetermined threshold. In block 1312, if the misalignment is below the predetermined threshold, at least one image trigger offset is applied to all entry image frames. However, if the misalignment is not below the predetermined threshold, in block 1314, the system calculates an optimized input image trigger offset. If the misalignment is not below the predetermined threshold, in block 1316, the system applies at least one image trigger offset to the entry frames.

[0137] In some embodiments, height imaging misregistration is addressed after image acquisition using a temporal filter that mitigates height misregistration artifacts. In one embodiment, one or more temporal filters are applied to B-mode images to eliminate or minimize height misregistration. A temporal filter can be applied by displaying an average of the previous N images, where N>1 (e.g., N=2, 3, 4, 5, 6, 7, 8, 9, 10, 25, 50, 100). This can be effective when imaging a static target and there is good spatial alignment between the averaged frames. However, in some embodiments, when the transducer or target is moving, the temporal filter may introduce a blurring effect as a result of imaging frames that lack lateral alignment being averaged together. In some embodiments, an adaptive temporal motion filter averages and / or stabilizes the B-mode image while the transducer is moving. In some embodiments, motion detection may be performed using one or more sensors. Such sensors may include a gyro or accelerometer. Additionally, in some embodiments, motion may be detected by the image itself. In one embodiment, an image correlation coefficient across multiple frames is calculated in real time.

[0138] In one embodiment, a temporal filter is activated (for the blending effect) when the imaging correlation coefficient is optimized and deactivated (to stop the blending effect) when the coefficient falls below a certain level.

[0139] In some embodiments, slight misalignment between consecutive frames (e.g., between a first image and a second image, an outgoing image, and an incoming image) results in a correlation coefficient that varies depending on the amount of misalignment. In one embodiment, to address this, at least two independent correlation coefficients are calculated. In one embodiment, one coefficient is calculated using only the outgoing image, and the second coefficient is calculated using only the incoming image. This results in more stable and reproducible coefficients between imaging transducers, and the combination of at least two coefficients can sustain a calculation rate of, for example, at least 6 frames per second. In one embodiment, the temporal stabilization filter is engaged by calculating a correlation coefficient between the current frame and the imaging frame and comparing the correlation coefficient to a threshold. In one embodiment, a correlation coefficient is calculated using the current frame and the imaging frame (e.g., 2, 4, 6, ...) prior, and this coefficient is compared to a threshold to determine whether the temporal stabilization filter is engaged.

[0140] 14, inaccurate imaging transducer positioning between the inner and outer tracks in a moving imaging device can cause image vibration and / or blur. In some embodiments, temporal motion artifacts can be quantified. Using raw quadrature detection (IQ) data, a correlation coefficient ("CC") is calculated between any two frames (e.g., frames F and G).

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[0141] In some embodiments, these calculations provide for maximizing the correlation coefficient and performing two-dimensional pattern matching to determine the location of each pixel within the image.

[0142] In one embodiment, when the temporal motion artifact is mapped as shown in Figure 15A, the temporal motion of the artifact appears to be primarily lateral. In one embodiment, when the temporal motion artifact is mapped as shown in Figure 15B, the temporal motion of the artifact appears to be stable in time. In one embodiment, when the temporal motion artifact is mapped as shown in Figure 15C, the temporal motion of the artifact appears to be uniform in depth. In some embodiments, the quantification of the temporal motion artifact varies from transducer to transducer.

[0143] 16A and 16B, in one embodiment that addresses imaging misalignment due to lateral shift only, measurements of the specific shift of each imaging transducer are made during the manufacturing of that imaging transducer. Using the measured shift value, the imaging system shifts the imaging data to the nearest pixel (e.g., nearest neighbor interpolation) based on the specific measured shift value. While this method stabilizes images solely with lateral shift, it cannot address out-of-plane movement and sub-pixel decorrelation, and imaging shift may persist. FIG. 16A shows an image in which pixels shift laterally with front-to-back and side-to-side movement. FIG. 16B shows the stabilized pixel alignment after application of a filter.

[0144] 17A and 17B, in one embodiment to address imaging misalignment in height, consecutive imaging frames are averaged in time to address lateral misalignment. In some embodiments, temporal averaging of consecutive frames stabilizes the image. In some embodiments, temporal averaging of consecutive frames can reduce speckle contrast and image resolution. FIG. 17A shows an image with pixels shifted in height. FIG. 17B shows stabilized pixel alignment after application of a filter.

[0145] 18A and 18B, in one embodiment, imaging misregistration and / or misalignment is reduced by both shifting the data (as in the embodiment of FIGS. 16A and 16B) and temporally averaging successive frames (as in the embodiment of FIGS. 17A and 17B). The shifted data maintains imaging resolution and corrects for consistently present large lateral motion artifacts (e.g., >1 pixel). The temporal averaging of successive frames minimizes smaller motion artifacts (e.g., <1 pixel) in any direction.

[0146] In one embodiment, the correlation coefficient increases when the image is stationary. In one embodiment, the correlation coefficient is less than 0.5. In one embodiment, the correlation coefficient may vary for each imaging transducer. In one embodiment, the correlation coefficient contrast changes slightly when comparing shifted images. In one embodiment, there is sub-pixel and out-of-plane decorrelation.

[0147] 19, in one embodiment, graph 1902 and graph 1904 show imaged pixels with lateral motion over time. In one embodiment, graph 1906 shows the correlation coefficient over time.

[0148] 20, in some embodiments, alternate frame correlation better reflects and accounts for the presence of motion during imaging, which in one embodiment helps minimize loss in frame rate and / or update rate.

[0149] In some embodiments, referring to FIG. 21 , an imaging system includes independently correlating outgoing and incoming images. In one embodiment, when the image is stationary, the correlation coefficient approaches 1, and when the image is moving, the correlation coefficient approaches 0. In one embodiment, the correlation coefficient varies between 0 and 1, 0 and 0.5, 0 and 0.4, 0 and 0.3, 0 and 0.2, or 0 and 0.1. In various embodiments, the correlation coefficient varies between imaging transducers. Graph 2106 illustrates one embodiment of a correlation coefficient approaching 1 over time.

[0150] 22A and 22B, an adaptive temporal motion filter with lateral misalignment correction corrects for lateral misalignment when motion is detected. In one embodiment, the temporal motion filter stabilizes imaging when the field of view is stationary. In one embodiment, the temporal motion filter is disabled when the field of view is moving, and treatment maintains temporal resolution.

[0151] The several embodiments and examples described herein are exemplary and are not intended to be limiting in describing the full scope of the compositions and methods of these inventions. Equivalent changes, modifications, and variations of the several embodiments, materials, compositions, and methods can be made within the scope with substantially similar results.

[0152] While the embodiments herein are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are described in detail herein. However, it should be understood that the embodiments are not limited to the particular forms or methods disclosed, but on the contrary, encompass all modifications, equivalents, and alternatives falling within the spirit and scope of the various described embodiments and the appended claims. The methods disclosed herein do not have to be performed in the order recited. The methods disclosed herein include specific actions performed by a practitioner. However, they may also include any third-party direction of those actions, either explicitly or implicitly. For example, an act such as "coupling a transducer module to an ultrasound probe" includes "instructing to couple the transducer module to the ultrasound probe." 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" are inclusive of the recited number. For example, "about 1 mm" includes "1 mm."

Claims

1. 1. An ultrasound imaging system configured to reduce imaging artifacts, comprising: An ultrasound probe, an ultrasound imaging transducer adapted to image the tissue region; a housing having an acoustic window; a dynamic offset distance between the ultrasound imaging transducer and the acoustic window, the dynamic offset distance varying over time, the dynamic offset distance comprising a first offset distance and a second offset distance, the first offset distance being different from the second offset distance; an acoustic coupling medium within the housing configured to acoustically couple the ultrasound imaging transducer to the acoustic window; a moving mechanism for moving the ultrasonic imaging transducer in a first direction and a second direction; Equipped with The ultrasound imaging transducer moves in the first direction to determine a focal zone sequence order (f 1 ,... ,f N ) and N>2, a second focal zone sequence order (f 1 ,... ,f N ) to take a picture, an ultrasound probe; a control module coupled to the ultrasound probe for controlling the ultrasound imaging transducer, the control module is configured to reduce at least one multipath echo artifact with a dynamically set pulse repetition interval. A control module; An ultrasound imaging system comprising:

2. The dynamically set pulse repetition interval is measuring a first offset depth; calculating a first offset time based on the first offset depth; multiplying the first offset time by an integer to determine the presence of the at least one multipath echo artifact; selecting a pulse repetition interval configured to position the at least one multipath echo artifact outside the displayed ultrasound image; The ultrasound imaging system of claim 1 , further configured to:

3. 1. An ultrasound imaging system configured to reduce imaging artifacts, comprising: An ultrasound probe, an ultrasound imaging transducer adapted to image the tissue region; a housing having an acoustic window; a dynamic offset distance between the ultrasound imaging transducer and the acoustic window, the dynamic offset distance varying over time, the dynamic offset distance comprising a first offset distance and a second offset distance, the first offset distance being different from the second offset distance; an acoustic coupling medium within the housing configured to acoustically couple the ultrasound imaging transducer to the acoustic window; a moving mechanism for moving the ultrasonic imaging transducer in a first direction and a second direction; Equipped with The ultrasound imaging transducer moves in the first direction to determine a focal zone sequence order (f 1 ,... ,f N ) and N>2, a second focal zone sequence order (f 1 ,... ,f N ) to take a picture, an ultrasound probe; a control module coupled to the ultrasound probe for controlling the ultrasound imaging transducer, the control module is configured to reduce at least one multipath echo artifact by dynamically setting one or more focal zone blend points. A control module; An ultrasound imaging system comprising:

4. The at least one dynamically set focal zone blend point is measuring a first offset depth; calculating a first offset time based on the first offset depth; multiplying the first offset time by an integer to determine the presence of the at least one multipath echo artifact; selecting at least one focal zone blend point configured to position the at least one multipath echo artifact outside the displayed ultrasound image; The ultrasound imaging system of claim 3 , further configured to:

5. 5. The ultrasound imaging system of claim 1, wherein the dynamic offset distance changes based on a changing volume of the acoustic coupling medium, the changing volume of the acoustic coupling medium being the result of evaporation or leakage of the acoustic coupling medium from the housing.

6. The ultrasound imaging system of claim 1 , wherein the dynamic offset distance changes based on a changing temperature of the acoustic coupling medium.

7. The ultrasound imaging system of claim 1 , wherein the dynamic offset distance changes based on a changing pressure of the acoustic coupling medium.

8. The ultrasound imaging system of claim 1 , wherein the dynamic offset distance varies with a speed of the moving mechanism in at least one of the first direction and the second direction.

9. The ultrasound imaging system of claim 1 , further comprising a therapy transducer configured to apply ultrasound therapy to the tissue.

10. The ultrasound imaging system of claim 1 , wherein N=2, 3, or 4.

11. 1. An ultrasound imaging system configured to reduce imaging artifacts, comprising: An ultrasound probe, an ultrasound imaging transducer adapted to image the tissue region; a housing having an acoustic window; a dynamic offset distance between the ultrasound imaging transducer and the acoustic window, the dynamic offset distance varying over time, the dynamic offset distance comprising a first offset distance and a second offset distance, the first offset distance being different from the second offset distance; means for moving the ultrasonic imaging transducer in a first direction and a second direction; Equipped with an ultrasound probe; a control module coupled to the ultrasound probe for controlling the ultrasound imaging transducer, the control module is configured to reduce at least one multipath echo artifact with a dynamically set pulse repetition interval. A control module; An ultrasound imaging system comprising:

12. 1. An ultrasound imaging module configured to reduce imaging artifacts, comprising: an ultrasound imaging transducer adapted to image the tissue region; a housing having an acoustic window; a dynamic offset distance between the ultrasound imaging transducer and the acoustic window, the dynamic offset distance varying over time, the dynamic offset distance comprising a first offset distance and a second offset distance, the first offset distance being different from the second offset distance; means for moving the ultrasonic imaging transducer in a first direction and a second direction; a control module coupled to the ultrasound probe for controlling the ultrasound imaging transducer; Equipped with the control module is configured to reduce at least one multipath echo artifact with a dynamically set pulse repetition interval. Ultrasound imaging module.

13. At least one dynamically set focal zone blend point is measuring a first offset depth; calculating a first offset time based on the first offset depth; multiplying the first offset time by an integer to determine the presence of the at least one multipath echo artifact; selecting at least one focal zone blend point configured to position the at least one multipath echo artifact outside the displayed ultrasound image; The ultrasound imaging module of claim 12 , further configured to:

14. 1. An ultrasound imaging device configured to reduce imaging artifacts, comprising: An ultrasound module, an ultrasound imaging transducer adapted to image the tissue region; a housing having an acoustic window; a dynamic offset distance between the ultrasound imaging transducer and the acoustic window, the dynamic offset distance varying over time, the dynamic offset distance comprising a first offset distance and a second offset distance, the first offset distance being different from the second offset distance; means for moving the ultrasonic imaging transducer in a first direction and a second direction; Equipped with an ultrasonic module; a control module coupled to the ultrasound probe for controlling the ultrasound imaging transducer, the control module is configured to reduce at least one multipath echo artifact with a dynamically set pulse repetition interval. A control module; An ultrasound imaging device comprising:

15. The at least one dynamically set focal zone blend point is measuring a first offset depth; calculating a first offset time based on the first offset depth; multiplying the first offset time by an integer to determine the presence of the at least one multipath echo artifact; selecting at least one focal zone blend point configured to position the at least one multipath echo artifact outside the generated ultrasound image; The ultrasound imaging device of claim 14 , further configured to:

16. 16. The ultrasonic imaging device of claim 14, wherein the dynamic offset distance changes based on a changing volume of an acoustic coupling medium, the changing volume of the acoustic coupling medium being the result of evaporation or leakage of the acoustic coupling medium from the housing.

17. The ultrasound imaging device of claim 14 , wherein the dynamic offset distance changes based on a changing temperature of an acoustic coupling medium.

18. The ultrasound imaging device of claim 14 , wherein the dynamic offset distance changes based on a changing pressure of an acoustic coupling medium.

19. The ultrasound imaging device of claim 14 , wherein the dynamic offset distance varies with the velocity of a mechanism in at least one of the first direction and the second direction.

20. The ultrasound imaging device of claim 14 , further comprising a therapy transducer configured to apply ultrasound therapy to the tissue.

21. 16. The ultrasound imaging device of claim 14, wherein N=2, 3, or 4.

22. 1. A method for reducing multipath echo artifacts from an ultrasound image, comprising: Providing an ultrasound probe, the ultrasound probe comprising: an ultrasound imaging transducer adapted to image the tissue region; a housing having an acoustic window; a dynamic offset distance between the ultrasound imaging transducer and the acoustic window, the dynamic offset distance varying over time, the dynamic offset distance comprising a first offset distance and a second offset distance, the first offset distance being different from the second offset distance; an acoustic coupling medium within the housing configured to acoustically couple the ultrasound imaging transducer to the acoustic window; a moving mechanism for moving the ultrasonic imaging transducer in a first direction and a second direction; Equipped with The ultrasound imaging transducer moves in the first direction to determine a focal zone sequence order (f 1 ,... ,f N ) and N>2, a second focal zone sequence order (f 1 ,... ,f N ) to take a picture, Steps and measuring a first offset depth; calculating a first offset time based on the first offset depth; multiplying the first offset time by an integer to determine the presence of the at least one multipath echo artifact; selecting a pulse repetition interval configured to position the at least one multipath echo artifact outside the displayed ultrasound image; A method comprising:

23. 1. A method for reducing multipath echo artifacts from an ultrasound image, comprising: Providing an ultrasound probe, the ultrasound probe comprising: an ultrasound imaging transducer adapted to image the tissue region; a housing having an acoustic window; a dynamic offset distance between the ultrasound imaging transducer and the acoustic window, the dynamic offset distance varying over time, the dynamic offset distance comprising a first offset distance and a second offset distance, the first offset distance being different from the second offset distance; an acoustic coupling medium within the housing configured to acoustically couple the ultrasound imaging transducer to the acoustic window; a moving mechanism for moving the ultrasonic imaging transducer in a first direction and a second direction; Equipped with Steps and calculating a first offset time based on the first offset depth; multiplying the first offset time by an integer to determine the presence of the at least one multipath echo artifact; selecting at least one focal zone blend point configured to position the at least one multipath echo artifact outside the displayed ultrasound image; A method comprising:

24. imaging the tissue; displaying the tissue; 24. The method of any one of claims 22 to 23, further comprising:

25. Without treating the tissue, imaging the tissue; displaying the tissue; 24. The method of any one of claims 22 to 23, further comprising:

26. treating the tissue; 24. The method of any one of claims 22 to 23, further comprising:

27. 1. A method for improving ultrasound imaging alignment by reducing spatial and temporal motion artifacts, comprising: Providing an ultrasound probe, the ultrasound probe comprising: an ultrasound imaging transducer adapted to image the tissue region; a movement mechanism attached to the ultrasonic imaging transducer; Equipped with The ultrasound imaging transducer moves in a first direction to determine a focal zone sequence order (f 1 ,... ,f N ) taking a first image at N>2; a second focal zone sequence order (f) when the ultrasound imaging transducer moves in a second direction; 1 ,... ,f N ) taking a second image; Steps and acquiring a first imaging frame; acquiring a second imaging frame; calculating an offset between the first imaging frame and the second imaging frame to determine a lateral displacement; displaying the first imaging frame; displaying the second imaging frame with the offset applied to reduce temporal motion artifacts; A method comprising:

28. calculating an optimized image using at least one trigger offset; applying the at least one trigger offset to a subsequent image acquisition; Further comprising: the lateral misalignment is reduced due to application of the at least one trigger offset.

28. The method of claim 27.

29. 1. A method for improving ultrasound imaging alignment by reducing spatial and temporal motion artifacts, comprising: Providing an ultrasound probe, the ultrasound probe comprising: an ultrasound imaging transducer adapted to image the tissue region; a movement mechanism attached to the ultrasonic imaging transducer; Equipped with The ultrasound imaging transducer moves in a first direction to determine a focal zone sequence order (f 1 ,... ,f N ) taking a first image at N>2; a second focal zone sequence order (f) when the ultrasound imaging transducer moves in a second direction; 1 ,... ,f N ) taking a second image; Steps and acquiring a plurality (N>1) of imaging frames; calculating a temporal average of at least two imaging frames; displaying the temporal average of the at least two imaging frames to reduce temporal motion artifacts; A method comprising:

30. calculating an optimized image using at least one trigger offset; applying the at least one trigger offset to a subsequent image acquisition; Further comprising: Averaging of N>1 consecutive imaging frames is enabled when the spatial misregistration between the current imaging frame and a previously acquired imaging frame is less than a predetermined threshold.

30. The method of claim 29.

31. 1. A method for improving ultrasound imaging alignment by reducing spatial and temporal motion artifacts, comprising: Providing an ultrasound probe, the ultrasound probe comprising: an ultrasound imaging transducer adapted to image the tissue region; a movement mechanism attached to the ultrasonic imaging transducer; Equipped with The ultrasound imaging transducer moves in a first direction to determine a focal zone sequence order (f 1 ,... ,f N ) taking a first image at N>2; a second focal zone sequence order (f) when the ultrasound imaging transducer moves in a second direction; 1 ,... ,f N ) taking a second image; Steps and acquiring a first imaging frame; acquiring a second imaging frame; calculating an offset between the first imaging frame and the second imaging frame to determine a lateral displacement; calculating a temporal average for the first imaging frame and the second imaging frame; displaying the temporal average of the first imaging frame and the offset relative to the second imaging frame to reduce spatial and temporal motion artifacts; A method comprising:

32. calculating an optimized image using at least one trigger offset; applying the at least one trigger offset to the optimized image; Further comprising: the lateral misalignment is reduced due to application of the at least one trigger offset.

32. The method of claim 31 .

33. imaging the tissue; displaying the tissue; 33. The method of any one of claims 27 to 32, further comprising:

34. Without treating the tissue imaging the tissue; displaying the tissue; 33. The method of any one of claims 27 to 32, further comprising:

35. treating the tissue; 33. The method of any one of claims 27 to 32, further comprising:

36. 1. An ultrasound imaging system configured to reduce imaging misalignment, comprising:

1. An ultrasound probe comprising: an ultrasound treatment transducer adapted to administer ultrasound treatment to tissue; an ultrasound imaging transducer adapted to image the tissue; and a movement mechanism for moving the ultrasound imaging transducer in a first direction and a second direction, the ultrasonic imaging transducer is mechanically attached to the movement mechanism; the first direction is opposite to the second direction; The ultrasound imaging transducer moves in the first direction to determine a focal zone sequence order (f 1 ,... ,f N ) and N>1; a second focal zone sequence order (f 1 ,... ,f N ) and take a picture. the spatial alignment between the first direction imaging and the second direction imaging is improved by shifting a trigger position; The ultrasound imaging system performs direction-dependent focal zone sequencing (f 1 ,... ,f N ) and (f 1 ,... ,f N ) an ultrasound probe; a control module coupled to the ultrasound probe for controlling the ultrasound imaging transducer; An ultrasound imaging system comprising:

37. 37. The method of claim 36, wherein N=any one of the group consisting of 2, 4, 6, and 8.

38. 37. The ultrasound imaging system of claim 36, wherein the first direction of transducer motion is any one or more of the group consisting of linear, rotational, and curved, and the second direction is a reverse path of the first direction.

39. 39. The ultrasound imaging system of any one of claims 36 to 38, wherein the ultrasound treatment is at least one of face lift, brow lift, chin lift, eye treatment, wrinkle reduction, décolleté improvement, buttock lift, scar reduction, burn treatment, skin tightening, vascular reduction, sweat gland treatment, sun spot removal, fat treatment, cellulite treatment, vaginal revitalization, acne treatment, and abdominal relaxation treatment.

40. An ultrasound imaging system having one or more of the features set forth in the preceding description.

41. A method for reducing imaging misalignment in a moving ultrasound transducer having one or more of the features set forth in the preceding description.

Images