Tilt-vibrating ultrasonic therapy device

Abstract

A method and system for ultrasound treatment. An ultrasound device having at least one tilting ultrasound transducer is deployed on skin tissue overlying a treatment area of ​​an internal tissue of a body part to be treated. The transducer is induced to transmit ultrasound energy to the skin tissue such that a body contacting surface device of the transducer connects with the skin tissue surface. A motor-driven oscillator coupled to the transducer is oscillated about a vibration axis relative to the skin tissue surface, thereby causing at least one of a position of the body contacting surface device, a tilting direction of the body contacting surface device, and a propagation direction of the transmitted ultrasound waves to oscillate about the vibration axis. The ultrasound device can be operated to move around on the skin tissue along at least one trajectory. Body shape parameters of the body part to be treated are measured using a measurement assembly including an imaging device, a green screen, and a scale marker.

Description

[Technical field]

[0001] The present invention relates generally to methods and devices for ultrasound treatment, and more particularly to cosmetic and therapeutic treatments using ultrasound devices. [Background technology]

[0002] Ultrasound therapy is an electrical therapy that has been used in physical therapy for almost a century. Ultrasound therapy is applied primarily for its non-thermal effects, as high-frequency sound waves initiate vibration and activity of cellular material, which may enhance the healing rate of certain soft tissues. In particular, ultrasonic energy may increase blood flow in the area to which it is applied, to accelerate the resolution time of inflammatory processes and stimulate the production of collagen (the main protein in tendons and ligaments) during tissue healing. Common injuries treated by ultrasound include bursitis, tendonitis, pulled and torn muscles, osteoarthritis, and ligament and tendon injuries. In recent years, the use of physical therapy equipment and techniques for cosmetic body treatments, also called "physio-esthetics," has become more popular, resulting in a proliferation of physical therapy centers and practitioners offering cosmetic treatments alongside conventional treatments.

[0003] A commonly accepted technique for applying ultrasound therapy requires an operator to place an ultrasound transducer on the skin in the area of ​​the tissue requiring treatment and perform slow massaging movements in a circular or stroking movement pattern (e.g., back and forth and / or side to side). The circular or stroking movement pattern serves a dual purpose, first, by creating a massaging effect that combines with the ultrasound exposure to enhance the therapeutic effect on the tissue being treated, and second, by distributing the treatment over a broad area that includes the tissue being treated.

[0004] The pace at which the transducer is advanced along the skin may be derived from conflicting factors. On the one hand, the need for effective energy absorption in the internal tissues necessitates that the transducer be held in a fixed position on the body. On the other hand, it is desired to reduce the emission time at any one location to prevent damage to the skin and subcutaneous tissue. This conflict is exacerbated by the fact that the emitted energy is highest at the tip of the transducer and dissipates rapidly as the emission propagates through the tissue layers. This reinforces the need for prolonged excitation of the internal tissues at sufficiently high energy levels to obtain the desired therapeutic or cosmetic effect, however, it also increases the risk of damage to the outer skin and subcutaneous tissue as the energy levels are increased and the excitation time is extended at any one location.

[0005] A comprehensive review conducted by Robertson and Baker (Physical Therapy, Volume 81, Issue 7, July 1, 2001, pp. 1339-1350) questioned the effectiveness of the commonly accepted and popular method of therapy of applying ultrasound energy to treat a variety of physiotherapy problems. After analyzing 35 studies, they concluded that "there is little evidence that active therapeutic ultrasound is more effective than placebo ultrasound for treating people with pain or a range of musculoskeletal disorders or for promoting soft tissue healing."

[0006] Korean Registered Patent No. 102094905, entitled "Hand-piece of Ultrasonic Therapy System for Treatment, and Ultrasonic Therapy System for Treatment Having the Same" issued to IUCF Sunmoon University (KR), discloses a hand-piece body having an ultrasonic ceramic unit disposed at its front end, configured to contact the patient's skin and apply ultrasonic energy to the patient's skin. An ultrasonic ceramic rotation motor disposed in the hand-piece body rotates the ultrasonic ceramic unit flat against the patient's skin, and a ceramic support spring member elastically supports the ultrasonic ceramic unit to enhance massage capability along curved surfaces. By automatically rotating the ultrasonic ceramic unit in contact with the skin, the invention is intended to facilitate stable treatment over an extended period of time, enhance ultrasonic therapy efficiency, and prevent the operator from developing wrist pain and infection.

[0007] U.S. Patent Application Publication No. 2012 / 0310232, issued to Erez and entitled "System and method for treating a tissue using multiple energy types," relates to skin treatment using a combination of unfocused ultrasound and radio frequency (RF) energy. At least two planar transducers are configured to generate acoustic waves at the surface and inner layers of the skin. A plurality of RF electrodes are configured to emit a plurality of RF signals. A control unit is configured to control the transducers such that interference of the acoustic waves maintains a predetermined level of energy in specific tissue below the surface of the skin.

[0008] JP 2009-291600, entitled "Oscillator fixture having oscillator angle-varying mechanism" issued to TEIJIN PHARMA LTD, discloses an oscillator fixture for an ultrasonic transducer. The oscillator fixture includes one or more shafts and is divided into two or more structures connected to each other by an angle-varying rotation mechanism.

[0009] US Patent Application Publication No. 2011 / 0112445, issued to Naldoni and entitled "Handpiece for ultrasound treatments of human tissue", discloses a handpiece for performing ultrasound treatments of human tissue for removing focal adiposity, cellulite, etc. The handpiece comprises a box-shaped body representing a basin-like concave element, the contour (CNT) of which, in use, is placed on the skin to be treated. The handpiece comprises two ultrasonic transducers arranged in the walls of the concave element, the ultrasonic transducers being tilted relative to each other at an adjustable angle by electromechanical means. Between the two ultrasonic transducers, an inlet is provided which is connected to a vacuum pump. The inlet is adapted to lift a portion of the skin so that two adjacent portions of the skin covered with massage oil or gel are brought into contact with the ultrasonic transducers.

[0010] Korean Patent Application Publication No. 2017-0048289A, entitled "Ultrasound cartridge for high intensity focused ultrasound device", discloses an ultrasound cartridge for a high intensity focused ultrasound device used in association with an operating handpiece of an ultrasound device for skin cosmetic treatment. The ultrasound cartridge is removably attached to the operating handpiece. The cartridge body is filled with a medium for transmitting ultrasound to one side and has a transmitting member for transmitting ultrasound. An ultrasound diagnostic unit is provided in the cartridge body to non-invasively generate a thermal focus of high intensity focused ultrasound (HIFU) at a predetermined depth from the surface of the skin through a transparent member during operation. The ultrasound treatment unit includes a first transducer and a second transducer for converting electrical energy into ultrasound energy, and the transducers may be arranged sequentially along the longitudinal direction of the handpiece.

[0011] U.S. Patent Application No. 2018 / 0353778, issued to Jeong and entitled "Therapeutic ultrasonic wave generating device," includes a rotary motor, an ultrasonic generating unit provided with a transducer for generating ultrasonic waves, and a focus rotation moving unit for moving the focus of ultrasonic waves generated by the ultrasonic generating unit in a circle in the same plane by receiving the transmission of the rotational force of the rotary motor. The device allows the focus of ultrasonic waves to be moved in a circle having a constant radius at a uniform depth under the skin, and allows energy to be applied uniformly and evenly within the moving radius for improved therapeutic performance. [Prior art documents] [Patent documents]

[0012] [Patent Document 1] Korean Patent No. 102094905 [Patent Document 2] US Patent Application Publication No. 2012 / 0310232 [Patent Document 3] Patent Publication No. 2009-291600 [Patent Document 4] US Patent Application Publication No. 2011 / 0112445 [Patent Document 5] Korean Patent Application Publication No. 2017-0048289A [Patent Document 6] U.S. Patent Application No. 2018 / 0353778 [Patent Document 7] U.S. Patent No. 9345909B2 [Non-patent literature]

[0013] [Non-Patent Document 1] Robertson and Baker, Physical Therapy, Volume 81, Issue 7, July 1, 2001, pp. 1339-1350 Summary of the Invention [Means for solving the problem]

[0014] According to one aspect of the present invention, therefore, a system for ultrasound treatment is provided. The system includes an ultrasound device and a measurement assembly. The ultrasound device includes at least one tilting ultrasound transducer with a body contacting surface instrument, the tilting ultrasound transducer is configured to be deployed to skin tissue above a treatment area of ​​an internal tissue of a body part to be treated and transmit ultrasound energy such that the body contacting surface instrument connects with the surface of the skin tissue. The ultrasound device further includes an oscillator driven by a motor, coupled to the tilting ultrasound transducer and configured to vibrate about a vibration axis relative to the surface of the skin tissue such that at least one of the position of the body contacting surface instrument and the tilt direction of the body contacting surface instrument vibrates about the vibration axis. The measurement assembly is configured to measure body shape parameters of the body part to be treated by the ultrasound device. The measurement assembly includes a green screen, a plurality of scale markers, at least one imaging device, and a processor. The scale markers are arranged at respective predetermined distances from each other to form a one-dimensional or two-dimensional plane parallel to the green screen, the one-dimensional or two-dimensional plane being shared by the body part to be treated. The imaging device is operable to capture images of the body part to be treated and the scale markers on a green screen background. The processor is configured to receive the images from the imaging device and process the images to measure body shape parameters of the body part to be treated. The generator may be configured to oscillate the propagation direction of the ultrasonic energy by dynamically changing the transmission direction of the ultrasonic waves relative to the body contacting surface instrument. The ultrasound device may include a plurality of ultrasonic transducers, and the generator may be configured to oscillate the propagation direction of the ultrasonic energy by sequentially activating and deactivating each one of the ultrasonic transducers according to a sequence pattern.The body contacting surface instrument may be configured to be tilted relative to the surface of the skin tissue to form a non-linear tilting transducer angle between an axis parallel to the body contacting surface instrument and an axis parallel to the skin surface, and the oscillator may be configured to vibrate to dynamically vary the tilting transducer angle while the body contacting surface instrument massages the skin tissue. The ultrasonic device may be configured to be manipulated over the skin tissue along at least one trajectory. The ultrasonic device may further include a distal engagement ring configured to surround the tilting ultrasonic transducer and to be selectively extended distally to engage the skin tissue to stabilize the ultrasonic device when the tilting ultrasonic transducer is activated. The body contacting surface instrument may be configured to be tilted relative to the surface of the skin tissue to form a tilting transducer angle in the range of 0.5° to 30° between an axis parallel to the body contacting surface instrument and an axis parallel to the surface of the skin tissue. The ultrasonic device may further include a plurality of electrodes configured to apply interferometric electrical stimulation to the skin tissue during operation of the tilting ultrasonic transducer. The ultrasonic device may further include at least one suction unit configured to provide vacuum suction to skin tissue during operation of the tilting ultrasonic transducer. The ultrasonic device may further include at least one stabilizing arm coupled to the body of the ultrasonic device to stably position the ultrasonic device and facilitate operation of the ultrasonic device. The ultrasonic device may further include at least one non-tilting ultrasonic transducer configured to be deployed onto the skin tissue and transmit ultrasonic energy. The ultrasonic device may include multiple ultrasonic transducers, and the oscillator may be configured to harmonize vibrations of the multiple tilting ultrasonic transducers to generate an interference pattern in the internal tissue.

[0015] According to another aspect of the present invention, therefore, a method for ultrasonic therapy is provided. The method includes the steps of: deploying at least one tilting ultrasonic transducer of an ultrasonic device on skin tissue above a treatment area of ​​an internal tissue of a body part to be treated, the tilting ultrasonic transducer including a body contacting surface device. The method further includes the steps of guiding the tilting ultrasonic transducer to transmit ultrasonic energy to the skin tissue such that the body contacting surface device connects with the surface of the skin tissue. The method further includes the steps of vibrating an oscillator driven by a motor, coupled to the tilting ultrasonic transducer, about a vibration axis relative to the surface of the skin tissue such that at least one of the position of the body contacting surface device and the tilt direction of the body contacting surface device vibrates about the vibration axis. The method further includes measuring the body shape parameters of the body part to be treated by positioning the body part to be treated in front of a green screen of the measurement assembly, positioning a plurality of scale markers of the measurement assembly at predetermined respective distances from each other to form a one-dimensional or two-dimensional plane parallel to the green screen, the one-dimensional or two-dimensional plane being shared by the body part to be treated, capturing images of the body part to be treated and the scale markers on a background of the green screen by at least one imaging device of the measurement assembly, and processing the images to measure the body shape parameters of the body part to be treated. The oscillation of the oscillator may be configured to oscillate the propagation direction of the ultrasonic energy by dynamically changing the transmission direction of the ultrasonic waves relative to the body contacting surface instrument. The ultrasonic device may include a plurality of ultrasonic transducers, and the oscillation of the oscillator may be configured to oscillate the propagation direction of the ultrasonic energy by sequentially activating and deactivating each one of the ultrasonic transducers according to a sequence pattern. The body contacting surface appliance may be configured to be tilted relative to a surface of the skin tissue to form a non-linear tilt transducer angle between an axis parallel to the body contacting surface appliance and an axis parallel to the skin surface, and vibration of the oscillator may be configured to dynamically change the tilt transducer angle as the body contacting surface appliance massages the skin tissue.The method may further include manipulating the ultrasound device on the skin tissue along at least one trajectory. The method may further include selectively extending distally a distal engagement ring surrounding the tilting ultrasound transducer to engage the skin tissue to stabilize the ultrasound device when the tilting ultrasound transducer is actuated. The body contacting surface instrument may be configured to be tilted relative to the skin tissue surface to form a tilting transducer angle in the range of 0.5° to 30° between an axis parallel to the body contacting surface instrument and an axis parallel to the surface of the skin tissue. The method may further include applying an interferential electrical stimulus to the skin tissue using a plurality of electrodes during operation of the tilting ultrasound transducer. The method may further include providing a vacuum suction to the skin tissue using at least one suction unit during operation of the tilting ultrasound transducer. The method may further include deploying at least one non-tilting ultrasound transducer on the skin tissue and guiding the non-tilting ultrasound transducer to transmit ultrasound energy. The method may further include coordinating vibrations of the multiple tilting ultrasound transducers to produce an interference pattern in the internal tissue. The method may further include vibrating an integrated transducer unit formed by the multiple tilting ultrasound transducers such that each of the transducers moves in response to the vibrations of the integrated transducer unit.

[0016] The present invention will be more fully understood and appreciated from the following detailed description taken in conjunction with the drawings, in which: [Brief description of the drawings]

[0017] [Figure 1A] 1 is a diagram of an ultrasound system constructed and operative in accordance with an embodiment of the present invention; [Figure 1B] FIG. 1B is a cross-sectional view of the ultrasound device of FIG. 1A. [Figure 1C] FIG. 1C is an enlarged cross-sectional view of a distal portion of the ultrasound device of FIG. [Figure 1D] FIG. 1B is a view of the ultrasound device of FIG. 1A shown from the distal end. [Figure 1E] 1B is a diagram of the ultrasound device of FIG. 1A and an excited region of a body portion that receives ultrasound energy transmitted by the device. [Figure 1F] FIG. 1 is a diagram of an ultrasound device including an ultrasound transducer having an annular skin-contacting section, constructed and operative in accordance with an embodiment of the present invention. [Figure 1G] FIG. 1F is a bottom view of the ultrasound device of FIG. [Diagram 2] 1 is a diagram of an ultrasound device including a stabilization arm, constructed and operative in accordance with an embodiment of the present invention. [Figure 3A] 1 is a diagram of an ultrasound device including multiple tilting ultrasound transducers, constructed and operative in accordance with an embodiment of the present invention. [Figure 3B] FIG. 3B is a top perspective view of a transducer of the ultrasound device of FIG. 3A tilting and rotating to shift the location of constructive interference, constructed and operative in accordance with an embodiment of the present invention. [Figure 4] 1 is a top view of an ultrasound device operating in accordance with an embodiment of the present invention as viewed from above the trajectory of the ultrasound device being manipulated over skin tissue. [Diagram 5] 1 is a diagram of a measurement assembly for measuring body shape parameters of a body part being treated by an ultrasound device, constructed and operative in accordance with an embodiment of the present invention; [Figure 6] FIG. 1 is a block diagram of a method for ultrasound therapy operable in accordance with an embodiment of the present invention. [Figure 7] FIG. 7 is a block diagram of an ultrasonic wave transmitting and vibrating procedure of the method for ultrasonic therapy of FIG. 6, operable in accordance with an embodiment of the present invention. [Figure 8] FIG. 7 is a block diagram of a procedure for measuring body shape parameters of the method for ultrasound therapy of FIG. 6, operable in accordance with an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] The present invention overcomes the shortcomings of the prior art by providing an ultrasound device and method for effectively delivering therapeutic or cosmetic ultrasound and massage therapy to treated internal tissue of a patient over an extended treatment session without harming external tissue layers. The device includes an oscillator and at least one ultrasonic transducer. The transducer is operable to tilt and rotate at a non-linear (i.e., not 180°) angle relative to the patient's skin tissue while the body is stabilized on the skin tissue to direct unfocused ultrasonic energy to a treatment area of ​​the internal tissue underlying the skin tissue.

[0019] The terms "user" and "operator" are used interchangeably herein to refer to any individual or group of persons who uses or operates the methods or systems of the present invention, such as a physical therapist or physician qualified to perform therapeutic and / or cosmetic ultrasound procedures.

[0020] The term "patient" is used herein to refer to a person on whom the method or system of the present invention operates, such as a person undergoing a therapeutic or cosmetic ultrasound procedure.

[0021] As used herein, the term "concurrently" and all variations thereof also encompasses a predetermined period of time prior to and a predetermined period of time after the duration under consideration. Thus, a first procedure described as being performed "concurrently" with a second procedure may be performed, for example, immediately prior to, immediately after, and / or during the second procedure.

[0022] As used herein, the expression "component / element X is perpendicular to surface B" refers to an angle of substantially 90° between an axis substantially parallel to surface B and an extension of component X adjacent to and extending perpendicularly from / into surface B. Correspondingly, the term "non-perpendicular" as used herein refers to an angle between component X and surface B that is not 90° (but is often within a close range of 90°, e.g., 80°, 95°, etc.), e.g., the angle of an oblique ultrasound wave propagating through the surface of skin tissue.

[0023] As used herein, the term "non-linear angle" refers to an angle between two contacting or nearly contacting substantially flat surfaces that is not 180°, for example, the angle between the distal face of a transducer and the skin surface.

[0024] Reference is now made to FIG. 1A, which is a diagram of an ultrasound device, generally designated 100, constructed and operable in accordance with an embodiment of the present invention. Reference is also made to FIG. 1B, which is a cross-sectional view of the ultrasound device 100 of FIG. 1A taken along the line designated AA. The ultrasound device 100 includes a body 110, a tilting ultrasound transducer 102, a body contacting surface instrument 104, an oscillator 106, a motor 120, and an engagement ring 112. The device 100 is defined as having a distal end and a proximal end, the distal end facing away from a user (not shown) holding the device 100 and directed toward the body of a patient (not shown), the distal end being depicted at the bottom of the device 100 in FIG. 1A and FIG. 1B. The body 110 is disposed at the proximal end of the device 100. The tilting ultrasound transducer 102 is disposed at the distal end of the body 110 adjacent to the skin tissue 150 of the patient. The body interface device 104 is the distal component of the transducer 102 that interfaces with the patient's body part to be treated, through which ultrasonic energy is transmitted. The generator 106 is disposed within the body 110 and is coupled to the transducer 102 via a coupling pin 108. The motor 120 is also disposed within the body 110 near the generator 106 and is electrically coupled to the generator 106. The engagement ring 112 is disposed at the distal end of the body 110 near the transducer 102 and radially surrounds the body 110 (i.e., about a radial axis). The motor 120 and the ring 112 may be considered optional components.

[0025] The patient's body part to be treated, e.g., the arm, includes external skin tissue 150 and internal tissue 160. Skin tissue 150 refers to the outer surface of the patient's body that is in direct contact with the transducer 102 during operation of the device 100 and may include one or more skin tissue layers (e.g., epidermis, dermis, and subcutaneous tissue). Internal tissue 160 may include any tissue substantially below the skin tissue 150 that is intended to be excited and treated by the transmitted ultrasound, including, but not limited to, subcutaneous adipose tissue (i.e., fat tissue), muscle tissue, connective tissue such as ligaments, tendons, and bone tissue, internal organs such as lungs, kidneys, female reproductive organs, etc. Treatment area 162 refers to the approximate area, typically within the internal tissue 160, that is considered to require treatment and to which the treatment of the device 100 is directed. It should be noted that treatment area 162 may be part of an integrated collection of tissues adapted to perform a common physiological function, such as tissues that form part of an internal organ. Non-limiting examples of the types of treatments to which the device 100 may be applied include all types of physiotherapeutic treatments such as carpal tunnel syndrome, shoulder periarthritis, tendonitis, ligament injuries, joint stiffness, treatments of internal organs, and various types of cosmetic treatments such as body modification or contouring processes, facelifts, wrinkle reduction, skin tightening of the face and neck, etc. The terms physiotherapy and physiotherapeutic treatments are used herein generally to include all types of medical care.

[0026] The body 110 has a generally elongated shape, allowing the body 110 to be comfortably grasped by an operator and manually manipulated to move about on the skin tissue 150 of the body part to be treated. The transducer 102 contacts the skin tissue 150 at an inclined or tilted angle and transmits ultrasound waves toward the internal tissue 160 underlying the skin tissue 150. An oscillator 106 rotates the transducer 102 relative to the skin tissue 150 such that the transducer 102 moves in a substantially circular motion in the skin tissue 150. A motor 120 provides power for the rotation of the oscillator 106 and the ultrasound transmission of the transducer 102. The engagement ring 112 is operable to be selectively extended toward and retracted from the skin tissue 150 as needed.

[0027] The operation of the ultrasound system 100 will now be generally described, followed by a description of specific examples.

[0028] When activated, the transducer 102 rotates to tilt in the skin tissue 150 and is continuously pressed against the surface of the skin tissue 150 at an angle oblique to an axis extending parallel to the skin surface. Referring also to FIG. 1C, the transducer 102 is shaped and / or positioned to contact the skin tissue 150 at a non-linear angle. An axis parallel to the body contacting surface appliance 104 forms an angle designated "α" with an axis parallel to the surface of the skin tissue 150. The body contacting surface appliance 104 may have a substantially flat panel-like shape or may have another surface shape, such as a convex shape, a corrugated shape, etc. If the shape of the body contacting surface appliance is not uniformly flat, an angle α may be defined between a tangent to a central portion of the body contacting surface appliance and the skin surface. The angle α may be in the range of 0.5° to 30°. In some embodiments of the invention, the angle α may be in a subrange of the above range, for example, in the range of 1° to 20°, in the range of 1.5° to 15°, and in the range of 2° to 5°. An exemplary angle α is 3.5°. The transducer 102 is operated to transmit ultrasound waves 122 while continuously tilting and rotating in a tilted circular formation. The tilted circular motion pattern of the transducer 102 may generate a periodic propagation pattern of ultrasound waves in the skin tissue. The periodic propagation pattern may be shaped in a cone, selectively diverging cone shape, such that at the junction between the transducer 102 and the skin tissue 150, a narrow end of the cone is generated by the ultrasound waves transmitted by the transducer 102, and within the underlying internal tissue 160, a diverging end of the cone is generated by the propagation of ultrasound waves. Alternatively, the cone shape may be a converging cone, whereby ultrasound waves generated by the transducer 102 at the external skin tissue 150 create a wider end of the cone, and propagation of the ultrasound waves in the underlying internal tissue 160 creates a narrower end, as described further herein in connection with Figures 1F and 1G. Any intermediate cone shapes may also be formed, depending on the movement pattern of the transducer 102.

[0029] Although the described movement pattern of the transducer 102 is a circular formation, the transducer 102 may alternatively be vibrated in a variety of movement patterns, such as a side-to-side pattern, a front-to-back pattern, a "figure-of-eight" formation, or any combination thereof. Thus, the term "rotation" and its grammatical variations used herein should be broadly interpreted to encompass a variety of systematic movement patterns, including circular and non-circular movement patterns. At least one of the location / position of the ultrasound transducer on the surface of the skin tissue 150 relative to the tissue to be treated, the magnitude of the angle α between the body-contacting surface of the ultrasound transducer and the skin surface, and the direction in which the angle α faces relative to true north or relative to the patient's body may change dynamically during the vibration cycle of the ultrasound transducer.

[0030] For example, if the vibration pattern of the ultrasound transducer (or its body-interfacing surface device) is a lateral tilt, the transducer starts a vibration cycle in a position where the angle (α) is at its maximum magnitude (for this particular vibration pattern) and facing a first direction relative to the patient's body (and / or relative to true north). During the vibration cycle, the transducer is selectively tilted to transition from facing the first direction to facing a second opposite direction, with the angle (α) reaching substantially the same maximum magnitude while facing the opposite direction. The trajectory of the transducer may be a substantially two-dimensional (2D) convex trajectory relative to the tissue to be treated, such that as the transducer tilts from a maximum angle / tilt on one side to a maximum tilt / angle on the opposite side, the magnitude of the angle (α) may gradually decrease until the body-interfacing surface device of the transducer is at a substantially straight angle relative to the skin surface, and then gradually increase until it reaches a maximum angle facing the opposite direction, continuing to move back and forth.

[0031] It should be noted that the angled propagation pattern of ultrasound waves in tissue generated by the transducer 102 may be selectively produced by a non-tilted, i.e., straight angled, ultrasound transducer, independent of the tilting motion of the ultrasound transducer. In this embodiment, the oscillator may act as a controller, activating and deactivating various transducers or sections of the transducer according to a sequential vibration pattern. For example, ultrasound waves may be transmitted from different sections of the transducer (i.e., subgroups of piezoelectric elements) in a phased array, causing the ultrasound waves to propagate at an angled inclination relative to the tangent of the body contacting surface panel. Alternatively, especially if the body contacting surface panel is not flat, ultrasound waves may be transmitted from different sections of the transducer in any sequential order, causing the various angles of the different sections of the body contacting surface panel to transmit ultrasound energy and propagate at various respective angles in the tissue to be treated. According to a similar principle, but with a somewhat reverse effect, the generator may be operable to continuously vibrate the ultrasound transducer (i.e., the body contacting surface device) at / against the skin tissue, so that the angle between the transducer and the surface of the skin tissue is continuously changing (as explained above with respect to the transducer 102), and at the same time, the generator may continuously change the section of the transducer from which the energy is transmitted, so that the propagation direction of the ultrasound energy may remain substantially unchanged despite the tilted vibration of the transducer. Any other combination between vibration of the direction in which the ultrasound energy is transmitted from the transducer and vibration of the angle and / or position of the transducer relative to the skin tissue may be applied. Different vibration patterns and combinations may be utilized interchangeably during a single treatment session.Additionally, vibration of the ultrasound waves in the skin tissue 150 may be accomplished without vibrating the ultrasound transducer along a trajectory or vibrating the transmission pattern of the ultrasound waves, for example, by positioning multiple ultrasound transducers at predetermined respective locations in a section of skin tissue and / or at predetermined angular inclinations relative to the skin tissue and vibrating the transmitted ultrasound energy by independently activating and deactivating each of the multiple transducers according to a predetermined sequence pattern controlled and coordinated by an oscillator. The alternating activation of the multiple transducers may be one in sequence for each transducer, synchronous activation of pairs of opposing transducers, or any other sequence pattern.

[0032] Thus, although transducer heads and / or ultrasound trajectories and movement / propagation patterns are described herein, options are included to produce the corresponding effects using alternative methods, including utilizing multiple fixed ultrasound transducers, transmitting ultrasound from partial sections of an ultrasound transducer, or other methods known in the art for manipulating ultrasound.

[0033] The vibration of the transducer 102 at an angled angle creates a massage effect on the skin tissue 150, which may enhance blood flow and lymphatic circulation in the underlying internal tissue 160. This angled vibration may make it difficult to maintain the transducer 102 in a desired position and in contact with the skin tissue 150 for effective delivery of energy to the underlying internal tissue 160. Thus, the body 110 may have a shape and size to facilitate stable positioning on the skin tissue 150 by an operator, with extensions to stabilize the activated transducer 102 and maintain the position of the transducer 102 on the skin tissue 150 while rotating to tilt. The shape of the body 110 may include, for example, an elongated or spherical shape, and may include a protruding handle, and / or other elements or features that allow an operator to maintain the body 110 in a substantially fixed and immovable alignment relative to the surface of the skin tissue 150. In one embodiment of the invention, the body 110 may be aligned substantially perpendicular to the skin tissue 150, i.e., such that the angle between the longitudinal axis of the body 110 and an axis parallel to the skin tissue 150 is substantially 90°. However, the alignment of the body 110 with respect to the skin tissue 150 may vary, for example, include a straight angle, a 45° angle, and / or may be adjustable depending on the body part that needs to be treated.

[0034] Reference is now also made to FIG. 1D, which is a diagram of the device 100 shown from the distal end, depicting the tilt-rotation movement pattern of the transducer 102. Reference is also made to FIG. 1E, which is a diagram of the device 100 and an excited area of ​​the body part that receives the ultrasound energy transmitted by the transducer 102. The transducer 102 rotates while tilting along a movement pattern 172 in the skin tissue 150. The angle α between the transducer 102 and the skin tissue 150 (shown in FIG. 1C) and the rotation of the transducer 102 cause the distal surface of the transducer 102, referred to herein as the transducer surface 103, to move continuously and continuously over a section of the skin tissue 150, referred to herein as the transducer contact section 154. The transducer contact section 154 includes the area of ​​the skin tissue 150 that the transducer surface 103 contacts in a complete rotation / vibration cycle when the device 100 is stationary. Thus, the area of ​​the transducer contact section 154 is larger than the area of ​​the transducer surface 103. The area of ​​the transducer contact section 154 is typically directly proportional to the angle α, i.e., a larger angle α between the transducer 102 and the skin tissue 150 typically results in a larger area of ​​the transducer contact section 154. However, the shape and area of ​​the transducer contact section 154 also depends on the overall shape of the transducer 102 and the movement pattern of the transducer 102 on the skin tissue 150.

[0035] The transducers 102 oscillate tiltingly while transmitting unfocused ultrasound waves 122 that are directed in a continuous sweeping pattern toward an internal tissue section 164 of the internal tissue 160 that is beneath the transducer contact section 154 of the skin tissue 150. The frequency of the ultrasound transmitted by the at least one transducer 102 may be in the range of 0.5-4.5 MHz and the ultrasound intensity may be in the range of 0.1-3.5 W / cm. 2The internal tissue section 164 may range from 0 to 100 mm in area to 150 mm in area to 200 mm in area to 300 mm in area to 400 mm in area to 500 mm in area to 600 mm in area to 700 mm in area to 800 mm in area to 900 mm in area to 1000 mm in area to 150 mm in area to 2000 mm in area to 500 mm in area to 6 ...

[0036] For example, if the radius of the transducer 102 is approximately R (transducer) = 2 cm, the transducer 102 is tilted at an angle α = 3.5°, and the transducer 102 rotates in a substantially circular pattern relative to the skin tissue 150, the resulting underlying internal tissue section 164 at a depth of about 5 cm below the surface of the skin tissue 150 has a diameter of about R (deep section) = 3 cm. In other words, the area of ​​the internal tissue section 164 excited by the transducer 102 is more than twice the area of ​​the transducer surface 103.

[0037] The tilting pattern of the transducer 102, resulting in an increased radius / area of ​​the transducer contact section 154 relative to the transducer 102 and an increased radius / area of ​​the internal tissue section 164 relative to the transducer contact section 154, may increase the delivery of ultrasonic energy to the internal tissue (160) while reducing the exposure of the external skin tissue 150 to high energy ultrasonic waves, as compared to a straight angled (i.e., non-tilted) ultrasound transducer. Through the tilting rotation of the transducer 102, the area of ​​the external skin tissue 150 in direct contact with the transducer 102 within the transducer contact section 154 is continually changed (as evidenced by the area of ​​section 154 being greater than the area of ​​the transducer 102). This helps prevent long-term exposure of any one portion of the external skin tissue 150 to high frequency ultrasound while the ultrasound device 100 is stationary at a particular location of the external skin tissue 150, allowing the ultrasound device 100 to remain at that particular location longer than would be possible with a parallel ultrasound transducer while avoiding damage to the external skin tissue. An ultrasound device 100 that remains stationary at a particular location for a longer period of time can increase excitation of the underlying internal tissue section 164, which may increase the effectiveness of the ultrasound treatment. Furthermore, because the internal tissue section 164 has a relatively large area compared to the transducer contact section 154, when the device 100 (including the transducer 102) is advanced from a first specific location to a next adjacent location of the external skin tissue 150, at least a portion of the first internal tissue section 164 underlying the first specific location continues to receive ultrasonic energy when the device 100 is positioned at the next adjacent location (i.e., the next internal tissue section 164 underlying the next adjacent location of the device 100 partially overlaps with the first internal tissue section 164), further enhancing excitation of the internal tissue 160.

[0038] From another perspective, the angled tilting of the ultrasonic transducer 102 may also enhance the massage effect produced by the transducer by providing a deeper and more diverse physical massage to the skin tissue 150 compared to a massage provided by a transducer rotating flat against the skin tissue. The shifting angle of the ultrasonic transducer 102 allows the transducer 102 to contact different portions of the skin tissue against which the transducer 102 is rotating at various angles, and the angular tilt of the transducer 102 may cause the transducer 102 to be pressed deeper against the skin tissue 150, especially at the distal end of the tilting transducer 102.

[0039] It should be noted that some possible advantages of the internal tissue section 164 having a larger area than the transducer contact section 154 are described above. However, the larger section 164 may only be the case in some rotation patterns of the tiltable ultrasound transducer 102, whereas other rotation patterns may have other advantages with respect to effective energy delivery to the internal tissue. For example, referring to FIG. 1F and FIG. 1G, the ultrasound transducer 182 of the ultrasound device 180 is tilted along a substantially circular orbit 184, such that in a complete rotation cycle, the transducer 182 contacts the external skin tissue 150 in a skin tissue area designated as the transducer contact ring 194. The center of the ring 194 may include a section of the skin tissue 150 that the transducer 182 does not contact when the ultrasound device 180 is stationary in a particular location. During tilting, the transducer 182 emits ultrasound waves 192 toward the underlying internal tissue. Due to the angular tilt and rotational pattern, the transducer 182 contacts a given portion of the external skin tissue 150 only once during each complete rotational cycle, and the ultrasound waves 192 excite a relatively focused internal tissue section 196 (which may have a smaller total area than the transducer contact ring 194, for example). The large area of ​​the contact ring 194 extends the duration that the ultrasound device 180 is maintained at a particular location of the skin tissue 150, i.e., substantially stationary, while substantially reducing the risk of damage to the external skin tissue 150. In particular, a given portion of the skin tissue 150 receives ultrasound energy directly from the transducer 182 and then has a rest period before receiving another amount of energy during which it is not exposed to direct energy for the remainder of the rotational cycle of the transducer 182. The effectiveness of ultrasound therapy generally depends on a sufficient amount and / or duration of excitation of the internal tissue, and these parameters are often compromised by the need to shift the location of the transducer to avoid damage to the external skin tissue.Extending the ultrasonic device 180 in one location, coupled with the relatively focused internal tissue section 196 of the ultrasonic waves 192, can increase the duration and amount of energy delivered to the internal tissue, while also reducing the risk of damage, and therefore can increase the effectiveness of excitation of the internal tissue.

[0040] As illustrated above (FIGS. 1A-1G), ultrasound devices can display a variety of angular tilts and vibration patterns of the ultrasound transducer, each of which may be individually advantageous for effectively exciting biological tissue. A common feature of such tilts and patterns is that the ultrasound transducer transmits ultrasound energy at a non-perpendicular angle to the skin tissue during at least a portion of the vibration cycle (although the transmitted ultrasound waves may be perpendicular to the skin tissue during some parts of the vibration pattern), causing the direction, angle and / or position at which the ultrasound waves are transmitted and propagating within the skin tissue to oscillate.

[0041] 1A and 1B, the oscillator 106 is operable to rotate in a plane substantially parallel to the skin tissue 150, and the oscillator 106 is coupled to the transducer 102 such that a parallel rotation of the oscillator 106 initiates a tilting rotation of the transducer 102. The oscillator 106 may be directly attached to the transducer 102 or may be coupled via a coupling element, such as a coupling pin 108. For example, the coupling pin 108 may be linearly continuous at the proximal end of the transducer 102 and may be attached to the outer periphery of the oscillator 106 to form a relative angle between the transducer 102 and the oscillator 106. The rotation of the transducer 102 is powered by a motor 120 through the oscillator 106, but may alternatively be powered by an alternative powering mechanism, such as a mechanical mechanism (e.g., a wound spring), or manually by an operator. The ultrasonic transmission of the transducer 102 may also be actuated by the motor 120 or may be actuated by a separate motor (not shown).

[0042] The engagement ring 112 surrounding the transducer 102 is operable to be selectively extended distally toward the skin tissue 150 during operation of the transducer 102 such that the ring 112 snugly engages the skin tissue 150 in intimate vertical contact while the transducer 102 tilts and rotates in an inclined circular formation relative to a transducer contact section 154 of the skin tissue 150 that is surrounded by the ring 112. The snug engagement of the ring 112 with the skin tissue 150 can help stabilize the positioning of the device 100 on the skin tissue 150 and can enable the transducer 102 to maintain intimate contact with the skin tissue 150 despite the tilting and rotation of the transducer 102. In the disclosed embodiment shown in FIGS. 1A-1C, the transducer 102 is substantially aligned with the body 110, but the transducer 102 may alternatively be positioned elsewhere in the vicinity of the body 110 and coupled thereto.

[0043] Treatment with the ultrasonic device 100 may be administered by an operator who grasps the body 110 and manually manipulates the device 100 over the skin tissue 150 to effectively excite a wide portion of the internal tissue 160 surrounding the treatment area 162 of the body part being treated. In experiments conducted, it was found that the effectiveness of treatment administered by existing rotatable ultrasonic devices known in the art, in which the rotating transducer is parallel to the skin tissue, is significantly more effective when the operator is trained to manually tilt and manipulate the device relative to the skin tissue of the patient, particularly to rotate the device in a tilted circular formation. However, training an operator to tilt and rotate the ultrasonic transducer during treatment to achieve the desired effect requires a significant amount of training time, such as a full month of training. Moreover, it is a physically demanding procedure, and operators are usually unable to administer this type of treatment for the duration of a complete treatment session, let alone a full day of treatment. Thus, the ultrasonic device of the present invention configured to tilt and rotate the ultrasonic transducer during treatment can substantially minimize the skill and effort required by the operator, and has been found to be substantially advantageous over existing ultrasonic treatment devices, producing significant therapeutic / cosmetic results from the first treatment session, even when performed by less experienced operators. The tilted vibration pattern of the transducer 102 can induce varying stimulation of different layers of the skin tissue due to the continuously changing angle at which the ultrasound waves are transmitted to the skin tissue, compared to the substantially fixed stimulation by a transducer rotating flat against the skin tissue. Such varying stimulation can limit, slow or prevent the rise in skin impedance that typically results from continuous ultrasound stimulation, the rise in impedance that often results in ultrasound waves that are less effectively propagated through the skin tissue, and reduced effectiveness. Minimizing the rise in skin impedance can enhance energy delivery by the transducer 102 to the internal tissue 160, which can result in more effective treatment.

[0044] The ultrasound device of the present invention may be configured to be attached to the skin tissue of a patient, eliminating the need for an operator to constantly hold the device in place. Reference is now made to FIG. 2, which is a diagram of an ultrasound device, designated 200, including a stabilizing arm, constructed and operable in accordance with an embodiment of the present invention. The ultrasound device 200 includes an ultrasound transducer 202 and an oscillator 206. The ultrasound device 200 is fixedly coupled to the skin tissue 150 via a stabilizing arm 230. Each stabilizing arm 230 is "L-shaped" such that a short "L-segment" of each stabilizing arm 230 is coupled to the body 210 of the device 200 at a proximal end and a long L-segment of each stabilizing arm 230 is coupled to the skin tissue 150 at a distal end. An adjustment spring 234 is disposed within the long "L-segment" of each stabilizing arm 230. An engagement ring 212 surrounding the ultrasound transducer 202 is coupled to a plurality of suction units 214 at the distal end of the ring 212. A distal transporter 232 is coupled to a distal end of each stabilization arm 230 and is configured to provide automated operation of the ultrasound device 200 .

[0045] The stabilizing arm 230 is operable to stably position and / or couple the ultrasound device 200 to the skin tissue 150. The arm 230 may be made of a rigid material (such as metal or plastic) and may include an adjustment mechanism, such as a spring 234, to adjust the length of the stabilizing arm 230 and / or the position of the arm 230 relative to the body 210 and / or skin tissue 150 as the device 200 is manipulated over the skin tissue 150. In particular, when the device 200 is applied over uneven skin tissue, such as around the arm, the spring 234 may compress and expand according to the changing skin surface. This may facilitate maintaining stability of the arm 230 on the skin tissue 150, which in turn maintains the stability of the body 210 while traversing the uneven surface of the skin tissue 150. The device 200 may include one or more stabilizing arms 230, such that multiple arms 230 may be distributed around the circumference of the body 210 at substantially equal distances or in an alternative distribution configured to balance and stabilize the body 210 on the skin tissue 150. For example, the device 200 may include two stabilizing arms 230 disposed on opposite sides of the body 210. The positioning of the arms 230 may be adjustable. For example, the proximal end of the arm 230 may be secured within a groove (not shown) cut along the circumference of the body 210, such that the proximal end of the arm 230 can be manipulated within the groove to adjust the position of the arm 230 relative to the body 210.

[0046] The stability provided by the arm 230 relative to the body 210 may allow the device 200 to be coupled and automatically operated on the skin tissue 150 without the need for an operator. A distal transporter 232 may be coupled to the arm 230 and may be powered by a motor to facilitate the advancement of the device 200 on the skin tissue 150. The trajectory of the device 200 on the skin tissue 150 via the transporter 232 may be remotely controlled or predetermined by an operator. The distal transporter 232 may include wheels, tracks, or other transportation means. The transporter 232 may be coupled to the stabilizing arm 230, the body 210, and / or another portion of the device 200. When operating an ultrasonic device, it may be difficult for an operator to always maintain the device at the correct pressure against the skin tissue 150 and advance the device at the correct advancement speed along the skin tissue 150 for effective delivery of ultrasonic energy while avoiding tissue damage, especially over an extended treatment period. Thus, attaching the device 200 to external skin tissue using the arm 230 and automatically maneuvering the device 200 over the skin tissue 150 using the transporter 232 can be particularly advantageous in maintaining optimal pressure and advancement speed of the transducer 202.

[0047] The suction unit 214 is operable to apply suction to the skin tissue 150. Applying vacuum suction to the tissue in the form of a massage may be utilized in addition to the massage effect provided by the transducer 202. Additionally, the suction unit 214 may enhance coupling and / or stability of the device 200 on the body part being treated. In particular, actuation of at least one suction unit 214 coupled to the distal end of the ring 212 may enhance snug engagement of the skin tissue 150 by the engagement ring 212 to secure the ultrasonic device 200 to the body part being treated and to continue to stabilize the transducer 202 while tilting and rotating on the skin tissue 150. The suction unit 214 may alternatively be coupled to the stabilizing arm 230, the distal transporter 232, the body 210, and / or other parts of the device 200. As will be further described with reference to FIG. 4, during a treatment session of the body part, the ultrasonic device 200 is typically manipulated slowly on the skin tissue 150. Slow operation of the ultrasonic device 200 may require remaining at a selected area of ​​the dermal tissue 150 for a short duration, such as about 1-3 seconds, before continuing to the next adjacent area to effect effective absorption of ultrasonic energy in the internal tissue. At least one suction unit 214 may be activated to apply suction upon arrival at a particular location of the dermal tissue 150 to secure the ultrasonic device 200 to the dermal tissue 150, and may be deactivated after a short duration (e.g., 1-3 seconds) to detach from the dermal tissue 150 and advance the ultrasonic device 200 to the next location of the dermal tissue 150.

[0048] In order for the transmitted ultrasound waves to reach the internal tissue at an effective energy level, the transducer provided in the skin tissue should transmit ultrasound energy at an energy level substantially higher than the effective energy level. However, such higher energy levels may be harmful to the skin tissue in case of prolonged exposure. One way to overcome this obstacle is by utilizing the effect of constructive interference. Constructive interference is the synthesis of multiple ultrasound waves incident in phase, i.e., at their wave energy maximum, at a particular location to generate an amplitude, i.e., energy level, that is the vector sum of the amplitudes of the ultrasound waves. Excitation of the internal tissue by coordinating the transmission of ultrasound waves to generate constructive interference in the internal tissue may enable the application of lower energy ultrasound waves in the skin tissue, which may provide a longer and more effective excitation.

[0049] Reference is made to Figures 3A and 3B. Figure 3A is a diagram of an ultrasound device, generally designated 300, including a plurality of tilting ultrasound transducers constructed and operable in accordance with an embodiment of the present invention. Figure 3B is a top perspective view of the transducer of the ultrasound device 300 of Figure 3A that tilts and rotates to shift the location of constructive interference, constructed and operable in accordance with an embodiment of the present invention. The ultrasound device 300 includes a plurality of tilting ultrasound transducers 302 configured to rotate at the skin tissue 150 while transmitting ultrasound energy to the skin tissue 150. Each transducer 302 is coupled to a body 310 of the device 300 and is positioned to contact and rotate at the skin tissue 150. An engagement ring 312 surrounds the transducer 302 and may be selectively elongated to forcefully press against the skin tissue 150 to stabilize the transducer 302 as it rotates. A plurality of electrodes 326 are coupled to the device 300 and configured to deliver electrical stimulation to the skin tissue 150. The transducers 302 may rotate independently or synchronously with each other. At least two transducers 302 may be positioned and oriented relative to each other to coordinate the propagation of the ultrasonic waves 322 transmitted by the transducers 302 to combine and generate constructive interference in the internal tissue 160. Referring to FIG. 3B, the angular vibration of at least one tilting ultrasonic transducer 302 may shift the location of the constructive interference in the internal tissue 160. The angular tilt rotation of at least one of the transducers 302 may cause the transmitted ultrasonic waves 322 to propagate in a sweeping pattern, e.g., a substantially circular or periodic pattern, in the internal tissue 160. The propagation of the ultrasonic waves 322 may result in a continuous change in the combination between the ultrasonic waves 322 transmitted by the transducers 302, providing a continuous shift of the location in the internal tissue 160 where constructive interference is generated. The vibration and direction of the ultrasonic transmission of multiple transducers 302 may be coordinated to generate a constructive interference pattern in the internal tissue 160.Shifting the location of constructive interference can fully excite the internal tissue treatment region 162 substantially below the location of the ultrasound transducer 302, increasing the effectiveness of ultrasound delivery to the treatment region 162 and potentially reducing treatment time. At least one of the transducers 302 is operable to tilt rotate when actuated, while at least another one of the transducers 302 can be a non-tilting ultrasound transducer, i.e., operable when actuated to transmit ultrasound energy toward the internal tissue 160 while rotating in the skin tissue at a straight (i.e., non-tilting) angle.

[0050] Electrical stimulation may also be provided to the skin tissue 150 by the electrodes 326 to enhance the propagation of the transmitted ultrasound waves 322 towards the internal tissue 160. The electrodes 326 may be coupled to the ultrasound device 300 and a controller (not shown) may adjust the operating and electrical parameters of the electrodes 326. Alternatively, the electrodes 326 may be part of a separate electrical stimulation device that may comprise a treatment system together with the device 300 and the controller. Additional features of the treatment system may include, for example, impedance monitors, imaging devices, and the like. The electrical stimulation provided by multiple electrodes 326 may be combined to generate coherent stimulation that may substantially reduce, keep constant, or otherwise change the impedance of the treated tissue 160 in general, and the tissue treatment region 162 in particular. Ultrasound treatment of body tissues has been found to change (usually increase) the impedance of the treated tissue, which may occur after only a few minutes of ultrasound treatment, resulting in reduced penetration of the ultrasound energy and reduced effectiveness of the treatment. Lowering, maintaining constant, or otherwise varying tissue impedance by electrical stimulation of body tissue with electrodes 326 may enhance propagation and facilitate deeper advancement of ultrasound waves 322 into the tissue being treated without the need to increase the energy level of the ultrasound waves 322. The electrodes 326 may be separate from the ultrasound device 300 or may be electrically coupled to the device 300 and / or may be coupled to components of the device 300, such as on the engagement ring 212 or the transducers 302. For example, the ultrasound device 300 may include four transducers 302, each transducer 302 including a respective electrode 326, such that the electrical stimulation applied by the four transducers 302 generates interfering beat frequencies within the tissue region encompassed by the transducers 302. As another example, electrical stimulation generated by at least one electrode 326 disposed externally to the ultrasound device 300 may interact with electrical stimulation generated by additional electrodes 326 of the transducer 302 to produce interference beat frequencies in the tissue region located therebetween.Further details regarding the parameters, recommended treatment plans, physiological effects, and benefits of interferential electrical stimulation treatment may be found, for example, in U.S. Patent No. 9,345,909 B2 to Ilan Feferberg, entitled "Skin Ulcer Treatment." The type of electrical stimulation applied by the electrodes 326 may include transcutaneous electrical nerve stimulation (TENS) and / or high voltage stimulation.

[0051] Multiple transducers 302 may be coupled to form an integrated transducer unit 308 (FIG. 3B). The transducer unit 308 may be vibrated by at least one oscillator 306 (shown in FIG. 3A). For example, the vibration of the integrated transducer unit 308 in the skin tissue 150 operates the transducers 302 on the skin tissue 150 in a substantially circular motion, i.e., a circular trajectory, with the movement of each transducer 302 corresponding to the movement of the integrated transducer unit 308. The vibration of the integrated transducer unit 308 may operate the transducers 302 in other movement patterns, such as a lateral pattern, a "figure eight" trajectory, etc. Alternatively, each of the ultrasonic transducers 302 may be configured to vibrate independently when the device 300 is substantially stationary at a particular location of the skin tissue 150. The circular rotation (or other movement pattern) of the transducer 302 when the device 300 is positioned at a particular location on the skin tissue 150 may serve multiple purposes. First, the changing position of the transducer 302 shifts the location where constructive interference occurs within the internal tissue 160, which may further enhance complete excitation of the internal tissue treatment region 162. Second, the constant movement of the transducer 302 over the skin tissue 150 reduces the exposure of any one region of the skin tissue 150 to high energy ultrasound. For example, if the gap (distance) between multiple transducers 302 is equal to the width of each transducer 302 with respect to the circumference of the integrated transducer unit 308 in which the transducers 302 are integrated, the rotation of the unit 308 may alternate the exposure of a given skin tissue region to equal periods of high energy ultrasound and then rest. This may substantially reduce the risk of damage to the skin tissue 150 from greater exposure to high energy ultrasound while extending the ultrasound transmission towards the underlying internal tissue 160. Furthermore, the continuous rotation of the integrated transducer unit 308, or the independent movement pattern of the transducers 302, may produce an additional beneficial massaging effect on the skin tissue 150 and underlying tissue layers.

[0052] The tilting vibration of the ultrasonic transducer may be advantageous to enhance energy delivery to a particular relatively wide section 164 of the internal tissue 160 underlying the ultrasonic device, while reducing the direct exposure of the corresponding skin tissue 150 to high energy ultrasonic waves. To effectively excite a broad portion of the internal tissue 160 surrounding the treatment area 162, while protecting the skin tissue 150 from exposure to excessive ultrasonic energy, the ultrasonic device may be manipulated continuously over the skin tissue 150. Reference is now made to FIG. 4, which is a top view of the trajectory of an ultrasonic device, referenced 400, operable in accordance with an embodiment of the present invention, manipulated over the skin tissue. The device 400 is manipulated systematically over the skin tissue 150, either manually or automatically (as described above), so as not to exclude areas of the skin tissue 150 and corresponding areas of the internal tissue 160. Trajectories for systematic operation of the device 400 may include, for example, an anterior-posterior trajectory 158 in which the device 400 moves alternately in anterior 182 and posterior 184 directions over the skin tissue 150 while advancing in a lateral direction 186, a coil spring trajectory 159 in which the device 400 moves in a circle substantially wider than the circular pattern of the rotatable ultrasound transducer 402 while advancing in anterior 182 and / or posterior 184 directions over the skin tissue 150, and / or an alternative trajectory that completely surrounds the area of ​​the skin tissue 150 above the treatment area 162.

[0053] The tilted rotation of the ultrasound transducer 402 relative to the skin tissue 150, as opposed to the customary perpendicular contact and straight angle rotation, allows the device 400 to be applied at selected locations on the skin tissue 150 for a more extended duration. The angled tilt of the transducer 402 causes the transducer 402 to sequentially partially contact different portions of the skin surface as it rotates, which may reduce sustained exposure to high ultrasound energy at a given portion of the skin tissue 150.

[0054] Reference is now made to FIG. 5, which is a diagram of a measurement assembly, generally referred to as 500, for measuring body shape parameters of a body part treated by an ultrasound device, constructed and operative in accordance with an embodiment of the present invention. The measurement assembly 500 may be utilized to track the effectiveness of ultrasound treatment for body contouring or body modification of one or more body parts, such as the abdomen, thighs, or arms. The measurement assembly 500 includes an imaging device 510, a green screen 512, a number of scale markers 514, a designated box 516, a processor 520, and a display screen 522. A patient 502 stands upright in front of the imaging device 510 within the designated box 516. The box 516 is adjacent to the green screen 512, which serves as a background for the patient 502 in images captured by the imaging device 510. The scale markers 514 are positioned at fixed locations and form a substantially two-dimensional (2D) plane 518 that includes the patient 502, the 2D plane 518 being parallel to the green screen 512 and the lens of the imaging device 510. While forming a 2-D plane may be advantageous, the scale markers 514 may alternatively be positioned to form a one-dimensional (1D) plane, i.e., the two scale markers 514 form a straight line parallel to the ground, and the 1D or 2D plane may not include the patient 502. The imaging device 510 captures an image of the patient 502. The processor 520 receives and processes the provided imaging data. A first processing step may include calculating the pixel / physical length scale (e.g., pixels / cm) of the provided image by measuring the number of pixels between each pair of the scale markers 514 and dividing the measured number by a predetermined actual physical distance between the scale markers. A subsequent processing step includes canceling the image content of the pixels in the image depicting the green screen 512. The processor 520 then determines the number of pixels within a plurality of spaced parallel torso lines 524 (i.e., parallel to each other and to the ground) extending across the torso of the patient 502 as depicted by the imaging device 510, where the torso boundary is discernible against the now empty green screen pixels.The processor 520 converts the measured number of pixels of the line 524 into a length measurement of the line 524 according to a calculated pixel or physical length (e.g., cm) scale. The length measurement may be stored for further analysis and / or provided to an operator. Alternatively, the absolute length of the patient's 502 torso may not be of interest, and instead, a change in torso length relative to an initial baseline may be sought, in which case measuring and pre-determining the physical distance of the scale markers 514 and converting the measured pixels into physical length may not be necessary. The imaging data captured by the imaging device 510 and provided to the processor 520 may be displayed on a display screen 522, for example after processing, such that only the patient 502 and the parallel torso lines 524 are shown. The operator may control and select specific torso lines 524 and specific measurements for display on the screen 522. For example, the operator can select a line or two points on the torso of the patient 502 to be displayed on the screen 522, and the processor 520 can perform selected measurements associated with the selected line or points, and the selected lines can be of different patterns and configurations (e.g., not necessarily straight parallel lines).

[0055] After an ultrasound therapy session for body modification, the treated body part of the patient 502 may undergo evaluation using the measurement assembly 500. Measurements may be taken at different time points after the treatment session, ranging from immediately after the treatment session to several months later. The imaging device 510 may be instructed to capture multiple images of the patient 502 and the treated body part. For example, images may be captured at various angles, such as front view, rear view, side view, etc., so that the processor 520 can measure the treated body part from different angles (e.g., using the torso line 524), which can provide a suitable indication of the change in body shape of the treated body part. It should be appreciated that the measurement of the treated body part is not limited to the parallel torso line 524, and alternative forms of image processing may be applied to provide an indication of the body shape and dimensions of the patient 502 and the change thereto after treatment. Additionally, other types of sensors may be utilized for measurements, such as radar sensors, which may measure the distance from a radar source to a selected point on the treated body part of the patient 502, which may provide an indication of the size or shape of the body part (e.g., waist circumference). Information captured and processed by the measurement assembly 500 may be stored for subsequent patient monitoring and analysis and tracking of the patient treatment process.

[0056] Reference is now made to FIG. 6, which is a block diagram of a method for ultrasound therapy, operable in accordance with an embodiment of the present invention.

[0057] In step 602, an ultrasound device is provided. The ultrasound device includes an oscillator and at least one tilting ultrasound transducer. For example, referring to FIG. 1A and FIG. 1B, the ultrasound device 100 includes a body 110, a tilting ultrasound transducer 102, a body contacting surface device 104, and an oscillator 106. The ultrasound transducer 102 is operable to transmit ultrasound energy through a body contacting surface device 104 disposed at a distal end of the transducer 102 and connected to a body part of a patient to be treated. The oscillator 106 is operable to vibrate the transducer 102, such as by vibrating about a vibration axis relative to skin tissue 150 of the body part to be treated. For example, the oscillator may rotate in a plane substantially parallel to the skin tissue 150 to induce a tilting rotation of the transducer on the surface of the skin tissue 150. The oscillator 106 and / or the transducer 102 may be powered by a motor 120.

[0058] A treatment session is initiated in procedure 604. With reference to Figures 1A-1G, an operator (not shown) initiates an ultrasound treatment session with a patient, such as to provide therapeutic and / or cosmetic ultrasound treatment to internal tissue 160 of a body part of the patient.

[0059] In step 606, the ultrasonic transducer is deployed on the skin tissue overlying a treatment area of ​​the internal tissue of the body part to be treated. For example, referring to FIGS. 1A-1C and 2, the transducer 102 is placed on the skin tissue 150 overlying a treatment area 162 of the internal tissue 160, such that the body contacting surface device 104 connects with the surface of the skin tissue 150. The body 110 can be shaped to be stabilized on the skin tissue 150, such as being maintained at a substantially perpendicular angle to the skin tissue, and to facilitate grasping by an operator. To help stabilize the placement of the device and to facilitate close contact of the transducer 102 with the skin tissue 150, an engagement ring 112 surrounding the transducer 102 can be extended distally to snugly engage the skin tissue 150. The device 100 can be stably positioned or coupled to the skin tissue via at least one stabilizing arm 230 coupled to the body 110 to facilitate automatic operation of the device 100 without the need for an operator.

[0060] In step 608, ultrasonic energy is transmitted to the skin tissue, vibrating at least one of the position of the body contacting surface appliance, the tilting direction of the body contacting surface appliance, and the propagation direction of the ultrasonic energy. For example, referring to FIG. 1A-FIG. 1G, at least one tilting ultrasonic transducer 102 is induced to transmit ultrasonic energy to the skin tissue 150 overlying the treatment area 162 of the internal tissue 160 while vibrating one or more features associated with the transducer 102 or the transmitted ultrasonic waves, such as by activating the vibration of the oscillator 106. For example, the vibration of the oscillator 106 may induce a rotation of the ultrasonic transducer 102 such that the transducer 102 (and in particular the body contacting surface appliance 104) moves in a substantially circular pattern along the skin tissue 150. The vibration of the oscillator 106 may further induce a tilt of the ultrasonic transducer 102 to repeatedly change the contact angle between the transducer 102 (and in particular the body contacting surface appliance 104) and the surface of the skin tissue 150. The transducer 102 may be tilted with respect to the surface of the skin tissue 150 at a non-perpendicular angle during at least a portion of the vibration cycle. The vibration of the oscillator 106 may further induce repeated changes in the propagation direction of the transmitted ultrasound waves, such as by changing the section of the transducer 102 from which the ultrasound waves are transmitted or by selectively activating different transducers 102. Thus, the vibration may be associated with dynamic changes in the location or position of the ultrasound transducer on the skin surface relative to the treatment area, the magnitude of the angle α between the body contacting surface device 104 and the skin surface, and / or the direction in which the angle α faces (e.g., relative to due north or the patient's body part). Different combinations may be applied between the vibration of the ultrasound propagation direction and the vibration of the angle and / or position of the transducer relative to the skin tissue. Different vibration patterns and combinations may be applied during a treatment session. Referring to FIG. 2, at least one suction unit 214 may provide vacuum suction on the skin tissue, which may provide an additional massage effect and increase the bond or stability of the device 200 on the body part being treated.Referring to FIG. 3, multiple transducers 302 can be actuated in a coordinated fashion such that transmitted ultrasound waves 322 combine to generate constructive interference within the internal tissue 160. At least one of the transducers 302 can be vibrated to shift the location of the constructive interference within the internal tissue 160. For example, angular tilt rotation of at least one transducer 302 can induce propagation of the ultrasound waves 322 in a sweeping pattern. Continuous changes in the combined propagation of the ultrasound waves 322 can be provided to repeatedly shift the location of the constructive interference. Multiple transducers 302 can form an integrated transducer unit 308 that can be subjected to vibration. Electrodes 326 can be applied to provide electrical stimulation in the skin tissue 150, such as interference electric field stimulation, to enhance the propagation of the transmitted ultrasound waves 322.

[0061] Reference is now made to Fig. 7, which is a block diagram of the ultrasound transmitting and vibrating step (step 608) of the method for ultrasound therapy of Fig. 6, operable according to an embodiment of the present invention. In substep 616, the transmission direction of the ultrasound to the body interface device is dynamically changed. With reference to Figs. 1B and 1E, the generator 106 induces vibrations to the body interface device 104, particularly to a tangent to a central portion of the body interface device 104, in the direction in which the ultrasound is transmitted from the ultrasound transducer 102. The vibrations can be performed by controlling and coordinating the activation and deactivation of different sections of the ultrasound transducer 102 to generate ultrasound in a specific sequence and / or phased array.

[0062] In substep 618, each of the plurality of ultrasonic transducers is selectively activated and deactivated. Referring to Figures 3A and 3B, the generator 306 activates and deactivates each of the plurality of ultrasonic transducers 302 disposed at respective locations on the skin tissue 150 according to a specified sequence pattern, such that each transducer 302 selectively transmits ultrasonic energy according to a coordinated sequence pattern.

[0063] In substep 620, the tilting transducer angle formed between an axis parallel to the body interface device and an axis parallel to the skin surface is dynamically changed while massaging the skin tissue. Referring to Fig. 1B and Fig. 1C, a tilting ultrasonic transducer 102 is deployed such that the body interface device 104 of the transducer 102 forms an angle α with the skin tissue 150. The generator 106 induces vibration of the transducer 102 such that the magnitude and / or direction of the angle α dynamically changes while the vibration of the body interface device 104 exerts a massage effect on the skin tissue 150. The dynamic change of the angle α may cause the propagation direction of the ultrasonic energy directed from the transducer 102 to form a sweeping energy pattern, such as a diverging or converging cone pattern, within the internal tissue 160, which may depend on the vibration trajectory of the body interface device 104 and the ultrasound transmission direction. 1E and 1F, some vibration patterns can result in ultrasonic excitation of a section 164 underlying the internal tissue 160 that is greater than the transducer contact section 154 in which the transducer 102 is vibrating.

[0064] Referring again to FIG. 6, in optional step 610, the ultrasound device is manipulated to move around on the skin tissue along at least one trajectory. Referring to FIG. 4, the ultrasound device 400 is manipulated over the skin tissue 150 (shown in FIG. 1B) to deliver ultrasound energy to a broad portion of the internal tissue 160, including the treatment area 162, while protecting the skin tissue 150 from exposure to excessive ultrasound energy. The device 400 may be manipulated systematically, manually (e.g., by an operator grasping and directing the body) or automatically (e.g., when the movement is powered by a mechanism such as a motor 220). The device 400 may traverse one or more trajectories, such as a front-to-back trajectory 158 or a coil spring trajectory 159, such as to pass completely over all applicable areas of the skin tissue 150 to effectively direct the ultrasound waves to a substantially broad portion of the treatment area 162. Referring to FIG. 2, one or more stabilizing arms 230 and a transporter 232 may be applied to facilitate movement of the ultrasound device 200.

[0065] The treatment session is ended in step 612. Referring to Figures 1A-1G, an operator (not shown) ends the ultrasound treatment session (previously started in step 604).

[0066] In step 614, a measurement assembly including an imaging device, a green screen, and a scale marker is used to measure body shape parameters of the body portion to be treated. Referring to Figure 5, a measurement assembly 500 is utilized to track the effectiveness of ultrasound treatments, such as body modification treatments using a vibrating ultrasound device of the disclosed embodiments.

[0067] Reference is now made to FIG. 8, which is a block diagram of a procedure (step 614) for measuring body shape parameters of the ultrasound treatment method of FIG. 6, operable according to an embodiment of the present invention. In sub-step 622, an image of the body part to be treated and the scale markers are captured on a green screen background, the scale markers being placed at predetermined respective distances to form a plane parallel to the green screen and shared by the body part to be treated. Referring to FIG. 5, the patient 502 is placed in front of the green screen 512 (e.g., standing on a designated box 516) and imaged by the imaging device 510, such as to capture the body part to be treated of the patient 502 from multiple viewing angles. The captured image further includes a number of scale markers 514 forming a plane, such as a 2D plane or a 1D plane (line), parallel to the green screen 512 and the lens of the imaging device 510.

[0068] In substep 624, the pixel-to-physical length scale of the captured image is calculated by measuring the number of pixels between the scale markers and dividing the measured number by the physical distance between the scale markers. Referring to Figure 5, for each captured image, the processor 520 determines the pixel / physical length (e.g., pixels / cm) scale for the image by measuring the number of pixels between each pair of scale markers 514 in the captured image and dividing the measured number of pixels by the actual length (physical distance) between the scale markers 514, which may be a predefined metric.

[0069] In substep 626, image content of pixels in the captured image that represent the green screen background is removed. Referring to Figure 5, processor 520 removes or eliminates image content associated with image pixels that represent the green screen 512 in the captured image.

[0070] In subprocedure 628, the number of pixels of the torso lines that extend across the dimension of the body part to be treated is measured in the captured image. With reference to FIG. 5, processor 520 measures the number of pixels in each of the parallel torso lines 524 that extend across the length and / or width of the torso (or other body part to be treated) of patient 502. In subprocedure 630, the measured number of torso line pixels is converted to a physical length measurement of the torso line. With reference to FIG. 5, processor 520 converts the measured number of pixels in each of torso lines 524 to a physical length measurement (e.g., cm) using a previously calculated pixel-to-physical length scale for the captured image.

[0071] In substep 632, an indication of the length measurement is provided or stored for further processing. Referring to FIG. 5, the processor 520 provides an indication of the determined (physical) body shape parameter measurement to an operator, such as by a display screen 522, and / or stores the measurement for further analysis and patient monitoring. Additional measurements may be taken at a later time after the treatment session. The body shape parameter measurements may be utilized to track the effectiveness of the ultrasound treatment.

[0072] In substep 634, an image including the selected lines and selected measurements of the body part may be displayed. Referring to FIG. 5, a display screen 522 may display an image captured by the imaging device 510, such as depicting the patient 502 and parallel torso lines 524. The operator may select particular body part features or particular measurements to be displayed. For example, the operator may select one or more points or lines in a pattern or configuration (e.g., a curved line or a set of intersecting lines) and select measurements (e.g., physical lengths) of the selected points or lines to be determined and displayed.

[0073] While certain embodiments of the disclosed subject matter have been described to enable those skilled in the art to practice the invention, the description is intended to be illustrative only and should not be used to limit the scope of the disclosed subject matter, which should be determined by reference to the claims that follow.

Claims

1. 1. A system for ultrasound therapy, comprising: an ultrasound device, a body contacting surface device comprising at least one tilting ultrasonic transducer, the tilting ultrasonic transducer configured to be deployed to skin tissue overlying a treatment area of ​​an internal tissue of a body part to be treated and to transmit ultrasonic energy such that the body contacting surface device interfaces with a surface of the skin tissue; a motor-driven oscillator coupled to the tilting ultrasonic transducer and configured to vibrate about a vibration axis relative to a surface of the skin tissue such that at least one of a position of the body contacting surface device and a tilting direction of the body contacting surface device vibrates about the vibration axis; a measurement assembly configured to measure body shape parameters of the body part to be treated by the ultrasound device, the measurement assembly comprising: Green screen and a plurality of scale markers arranged at respective predetermined distances from each other to form a one- or two-dimensional plane parallel to the green screen, the one- or two-dimensional plane being shared by the body part to be treated; at least one imaging device operable to capture images of the body part to be treated and the scale markers on a background of the green screen; a processor configured to receive the images from the imaging device and process the images to measure body shape parameters of the body part to be treated.

2. The system of claim 1 , wherein the generator is configured to oscillate a direction of propagation of the ultrasonic energy by dynamically changing a direction of transmission of ultrasonic waves relative to the body contacting surface device.

3. 2. The system of claim 1, wherein the ultrasonic device comprises a plurality of ultrasonic transducers, and the oscillator is configured to vibrate the direction of propagation of the ultrasonic energy by sequentially activating and deactivating respective ones of the ultrasonic transducers according to a sequence pattern.

4. 2. The system of claim 1, wherein the body contacting surface appliance is configured to be tilted relative to the surface of the skin tissue to form a non-linear tilting transducer angle between an axis parallel to the body contacting surface appliance and an axis parallel to the skin surface, and the oscillator is configured to vibrate to dynamically vary the tilting transducer angle while the body contacting surface appliance massages the skin tissue.

5. The system of claim 1 , wherein the ultrasound device is configured to be manipulated over the skin tissue along at least one trajectory.

6. 10. The system of claim 1, further comprising a distal engagement ring configured to surround the tilting ultrasonic transducer and to be selectively extended distally to engage skin tissue to stabilize the ultrasound device when the tilting ultrasonic transducer is activated.

7. 2. The system of claim 1, wherein the body contacting surface appliance is configured to be tilted relative to the surface of the skin tissue to form a tilt transducer angle between an axis parallel to the body contacting surface appliance and an axis parallel to the surface of the skin tissue in the range of 0.5° to 30°.

8. 10. The system of claim 1, further comprising a plurality of electrodes configured to apply interferential electrical stimulation to the skin tissue during operation of the tilting ultrasound transducer.

9. The system of claim 1 , further comprising at least one suction unit configured to provide vacuum suction to the skin tissue during operation of the tilting ultrasonic transducer.

10. 10. The system of claim 1, further comprising at least one stabilizing arm coupled to a body of the ultrasound device for stably positioning the ultrasound device and facilitating manipulation of the ultrasound device.

11. 10. The system of claim 1, further comprising at least one non-tilting ultrasound transducer configured for deployment onto the skin tissue and for transmitting ultrasound energy.

12. 2. The system of claim 1, wherein the ultrasound device comprises a plurality of tilting ultrasound transducers, and the oscillator is configured to coordinate vibrations of the plurality of tilting ultrasound transducers to produce an interference pattern in the internal tissue.

13. 2. The system of claim 1, wherein the ultrasound device comprises a transducer forming an integrated transducer unit configured to vibrate in the skin tissue such that each of a plurality of tilting ultrasound transducers moves in response to vibration of the integrated transducer unit.

14. 1. A method for ultrasound therapy, comprising: deploying at least one tilting ultrasonic transducer of an ultrasound device on skin tissue overlying a treatment area of ​​an internal tissue of a body part to be treated, the tilting ultrasonic transducer comprising a body contacting surface device; guiding the tilting ultrasonic transducer to transmit ultrasonic energy to the skin tissue such that the body contacting surface device engages a surface of the skin tissue; vibrating a motor-driven oscillator coupled to the tilting ultrasonic transducer about a vibration axis relative to a surface of the skin tissue such that at least one of a position of the body contacting surface device and a tilt direction of the body contacting surface device vibrates about the vibration axis; Positioning the body part to be treated in front of a green screen of a measurement assembly; Arranging a plurality of scale markers of the measurement assembly at respective predetermined distances from each other to form a one-dimensional or two-dimensional plane parallel to the green screen, the one-dimensional or two-dimensional plane being shared by the body part to be treated; capturing images of the body part to be treated and the scale markers on a background of the green screen by at least one imaging device of the measurement assembly; and processing said images to measure body shape parameters of said body part to be treated; measuring body shape parameters of the body part to be treated; 23. A method for ultrasound therapy comprising:

15. The method of claim 14 , wherein the vibration of the generator is configured to oscillate a propagation direction of the ultrasonic energy by dynamically changing a transmission direction of ultrasonic waves relative to the body contacting surface device.

16. 15. The method of claim 14, wherein the ultrasonic device comprises a plurality of ultrasonic transducers, and the vibration of the generator is configured to vibrate the direction of propagation of the ultrasonic energy by sequentially activating and deactivating respective ones of the ultrasonic transducers according to a sequence pattern.

17. 15. The method of claim 14, wherein the body contacting surface appliance is configured to be tilted relative to the surface of the skin tissue to form a non-linear tilt transducer angle between an axis parallel to the body contacting surface appliance and an axis parallel to the skin surface, and the vibration of the oscillator is configured to dynamically vary the tilt transducer angle as the body contacting surface appliance massages the skin tissue.

18. The method of claim 14, further comprising the step of manipulating the ultrasound device over the skin tissue along at least one trajectory.

19. 15. The method of claim 14, further comprising the step of selectively extending distally a distal engagement ring surrounding the tilting ultrasonic transducer to engage skin tissue to stabilize the ultrasound device when the tilting ultrasonic transducer is activated.

20. 15. The method of claim 14, wherein the body contacting surface appliance is configured to be tilted relative to the surface of the skin tissue to form a tilt transducer angle in the range of 0.5° to 30° between an axis parallel to the body contacting surface appliance and an axis parallel to the surface of the skin tissue.

21. 15. The method of claim 14, further comprising applying an interferential electrical stimulus to the skin tissue using a plurality of electrodes during operation of the tilting ultrasonic transducer.

22. The method of claim 14, further comprising the step of providing vacuum suction to the skin tissue using at least one suction unit during operation of the tilting ultrasonic transducer.

23. 15. The method of claim 14, further comprising the steps of: placing at least one non-tilting ultrasound transducer on the skin tissue; and guiding the non-tilting ultrasound transducer to transmit ultrasound energy.

24. 15. The method of claim 14, further comprising the step of coordinating the vibrations of a plurality of tilting ultrasonic transducers to produce an interference pattern in the internal tissue.

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