Sonotrode

Abstract

To provide devices suitable for treatment of subcutaneous tissue by transdermally inducing ultrasonic vibrations in subcutaneous tissue and / or transdermally delivering energy with electromagnetic radiation such as light to subcutaneous tissue.SOLUTION: In some embodiments, the treatment of subcutaneous tissue is effective in reducing the amount of subcutaneous fat therein. In some embodiments, transdermal radiation-delivery of energy and transdermal induction of ultrasonic vibrations in subcutaneous tissue can be performed simultaneously, alternatingly or in an unrelated fashion. In some embodiments, the device simultaneously transdermally induces both ultrasonic transverse and ultrasonic longitudinal vibrations in subcutaneous tissue.SELECTED DRAWING: Figure 4A

Description

[Technical Field]

[0001] [Related Applications] This application claims priority from U.S. Provisional Patent Application No. 63 / 052,828, filed July 16, 2020, and UK Patent Application No. GB ​​2105076.0, filed April 9, 2021, both of which are incorporated by reference as if fully set forth herein.

[0002] FIELD AND BACKGROUND OF THE INVENTION The present invention, in some embodiments, relates to the treatment of body tissue with energy, and more particularly, but not exclusively, to a device for the treatment of subcutaneous tissue by transcutaneously inducing ultrasonic vibrations in the subcutaneous tissue and / or transcutaneously delivering energy by electromagnetic radiation, such as light, to the subcutaneous tissue. In some embodiments, the treatment of the subcutaneous tissue is effective to reduce the amount of subcutaneous fat therein. In some embodiments, the transcutaneous radiation delivery of energy and the transcutaneous induction of ultrasonic vibrations in the subcutaneous tissue can be performed simultaneously, alternately, or in an unrelated manner. In some embodiments, the device simultaneously induces both ultrasonic transverse and longitudinal vibrations in the subcutaneous tissue. [Background technology]

[0003] In the art, for example in the field of body sculpting, it is known to apply ultrasonic vibrations to the skin surface to induce ultrasonic vibrations transcutaneously, and to acoustically supply energy to subcutaneous tissue such as the subcutaneous adipose tissue layer, thereby damaging fat cells.

[0004] Application of ultrasonic vibrations to the surface is typically performed by an apparatus 10 (see FIG. 1 ) including an ultrasonic transducer 12 for generating ultrasonic longitudinal vibrations (e.g., a Langevin-type transducer consisting of a stack of piezoelectric elements and an acoustic reflector 16 held together by an axial bolt 17) having a proximal face 14 and a distal face 18 operatively associated with an acoustic reflector 16, and a distal sonotrode 20 having a proximal face 22, a distal end 24 defining an active surface 26 of the sonotrode 20 constituting the acoustic emitting surface, and a sonotrode axis 28, wherein the proximal face 22 of the sonotrode 20 is acoustically coupled to the distal face 18 of the ultrasonic transducer 12. Typically, either or both of the acoustic reflector 16 and the sonotrode 20 are at least partially surrounded by a cooling component, such as a water-circulating cooling jacket, to cool these components during use.

[0005] In use, the ultrasonic transducer 12 is driven by an alternating current (AC) oscillating at an ultrasonic drive frequency supplied from an ultrasonic power supply 34 while the working surface 26 of the sonotrode 20 is acoustically coupled (e.g., by direct contact or indirect contact via a coupling substance, e.g., a liquid or gel) to the surface 30 of the medium 32. The piezoelectric elements of the ultrasonic transducer 12 expand and contract at the drive frequency in response to the oscillating AC potential, thereby generating ultrasonic longitudinal vibrations at the drive frequency. The generated ultrasonic longitudinal vibrations propagate within the sonotrode 20 parallel to the axis 28 from the proximal surface 22 to the working surface 26 of the sonotrode. The working surface 26 applies the ultrasonic longitudinal vibrations to the surface 30, inducing ultrasonic longitudinal vibrations in the medium 32.

[0006] For practical applications, it is advantageous to configure the sonotrode to function as an acoustic amplitude transducer that changes the amplitude of the ultrasonic longitudinal vibrations (i.e., the maximum displacement of the distal working surface 26) from relatively small at the proximal surface 22 of the sonotrode 20 to substantially larger, typically 10-150 μm, at the working surface 26. Such a configuration is advantageous when the total length 36 of the sonotrode (from the proximal surface 22 to the working surface 26) is λ longitudinal λ is an integer multiple of λ / 2. longitudinalis the wavelength of the ultrasonic longitudinal vibration of the sonotrode, and the sonotrode acts as a half-wave resonator. longitudinal The exact value of / 2 depends on the drive frequency and the longitudinal speed of sound along the axis 28 of the sonotrode 20.

[0007] An additional aspect of configuring a sonotrode to function as an acoustic amplitude transducer is for the sonotrode to taper distally from a larger cross section at the proximal end 22 to a smaller cross section closer to the working surface 26. The most common such tapered acoustic amplitude transducer configurations are shown schematically in side cross section in Figure 2: Figure 2A is a linear tapered sonotrode 38a, Figure 2B is an exponentially tapered sonotrode 38b, and Figure 2C is a step-tapered sonotrode 38c.

[0008] When sonotrodes 20, 38a, 38b or 38c as shown in Figures 1, 2A, 2B or 2C, respectively, are used, the ultrasonic vibrations induced in the medium 32 within the sonotrode are predominantly, if not entirely, longitudinal vibrations propagating collinearly with the sonotrode axis 28. The biological effects of energy delivered transcutaneously by ultrasonic longitudinal vibrations result primarily from heating of the tissue, particularly the dermis.

[0009] In Patent Publication US2011 / 0213279, which is incorporated by reference as if fully set forth herein, some of the inventors disclosed a "mushroom-shaped" sonotrode. In FIG. 2D, such a mushroom-shaped sonotrode 38d is shown schematically in side cross section with a tapered stem 40 (specifically similar to the stepped tapered sonotrode 38c shown in FIG. 2C) that functions as an acoustic amplitude transducer as described above, and a wider distal cap 42. The distal cap 42 is lenticular in side cross section, resembling a lens with a curved back surface 44 and a convex working surface 26. The working surface 26 of the sonotrode 38d also includes concentric shear-wave-transmitting ridges 46.

[0010] As detailed in US2011 / 0213279, sonotrodes such as 38d operate to transcutaneously induce ultrasonic longitudinal or transverse vibrations in the subcutaneous tissue when the active surface 26 is acoustically coupled to the skin, depending on the value of the drive frequency.

[0011] Without wishing to be bound by any one theory, it is presently believed that at a certain drive frequency, the ultrasonic longitudinal vibrations generated by the ultrasonic transducer 12 propagate preferentially parallel to the axis 28 of the mushroom-shaped sonotrode such as 38d from the proximal surface 22 to the working surface 26. These ultrasonic longitudinal vibrations primarily direct the ultrasonic longitudinal vibrations of the sonotrode 38d and are applied by the working surface 26 to the skin surface where they are acoustically coupled to the working surface 26, transcutaneously inducing ultrasonic longitudinal vibrations in the subcutaneous tissue.

[0012] However, at some other different drive frequencies, the ultrasonic longitudinal vibrations generated by the ultrasonic transducer 12 preferentially generate ultrasonic shear wave vibrations in the cap 42 of the sonotrode 38d, with the ultrasonic shear wave vibrations being perpendicular to the longitudinal vibrations in the stem 40. That is, a greater proportion of the energy transferred by the transducer 12 to the sonotrode 38d is in the ultrasonic shear wave vibrations in the cap 42 perpendicular to the axis 28 than in the ultrasonic longitudinal vibrations parallel to the axis 28. As a result, the working surface 26 vibrates substantially laterally, possibly alternating in diameter. When the vibrating working surface 26 is applied to the skin surface, the ultrasonic shear wave vibrations induce ultrasonic transverse wave vibrations in the subcutaneous tissue due to the convex shape of the working surface 26 and the concentric transverse wave-transmitting ridges 46, which can be thought of as physically moving the skin and tissue laterally. Devices including sonotrodes such as 38d provide two modes of operation: the wavelength λ of the sonotrode 38d configured to act as an acoustic amplitude transducer L a first "hot" or "longitudinal" mode in which energy delivered transcutaneously to the subcutaneous tissue via the working surface 26 is primarily by ultrasonic longitudinal vibrations perpendicular to the skin surface at a first drive frequency associated with and a second "cold" or "transverse" mode in which energy is delivered transcutaneously to the subcutaneous tissue via working surface 26 at a second drive frequency different from the first drive frequency by ultrasonic transverse vibrations primarily parallel to the skin surface. As described in US 2011 / 0213279, relatively low-energy "cold" ultrasonic transverse waves apparently destroy fat cells by repeatedly stretching and then relaxing their cell membranes, while causing substantially no collateral damage to surrounding non-adipose tissue.

[0013] In some preferred embodiments described in US 2011 / 0213279, a first mode of ultrasonic longitudinal wave vibrations and a second mode of ultrasonic shear wave vibrations are alternately applied via a mushroom-shaped sonotrode such as 38d. The ultrasonic longitudinal vibrations are applied to the skin surface by the working surface 26 (typically for a duration of about 5 seconds), transcutaneously inducing ultrasonic longitudinal waves that heat subcutaneous tissue such as the dermis. Subsequently, ultrasonic shear wave vibrations are applied to the skin surface by the working surface 26 (typically for a duration of about 15 seconds), inducing ultrasonic transverse vibrations that destroy fat cells. Due to the prior heating by the ultrasonic longitudinal vibrations, the ultrasonic transverse vibrations penetrate deeper and / or more effectively, and / or a greater proportion of their energy penetrates to a given depth of the fat tissue, and / or the heated tissue has improved energy absorption characteristics.

[0014] Although very effective in the field of body sculpting, sonotrodes such as those described in US2011 / 0213279 may not be considered ideal for some applications because the shear wave vibrations are not applied continuously, adding complexity to the generation and switching between two different drive frequencies, and because if the user moves the working surface too quickly over different parts of the subject, the treatment results may not be ideal.

[0015] In patent publication US2019 / 0091490, which is incorporated by reference as if fully set forth herein, some of the inventors disclosed a sonotrode that simultaneously induces both ultrasonic transverse vibrations and ultrasonic longitudinal vibrations percutaneously in subcutaneous tissue, with both modes of vibration being strong enough to provide substantial energy to achieve a desired bioeffect, e.g., substantial heating of the tissue by the induced longitudinal vibrations and substantial destruction of fat cells by the induced transverse vibrations. Furthermore, the energy provided by each one of the two modes is "balanced," i.e., during normal use by a body sculpting technician of ordinary skill in the art, the induced ultrasonic transverse vibrations are strong enough to effectively destroy fat cells, as described in US2011 / 0213279, while the induced ultrasonic longitudinal vibrations are strong enough to heat the subcutaneous tissue sufficiently to increase the efficacy of the induced ultrasonic transverse vibrations without being so strong as to easily cause potentially catastrophic overheating of body tissue (e.g., burns, scarring). The inventors believe that the sequential and simultaneous induction of both transverse and longitudinal vibrations is what leads to the particular efficacy of the sonotrode disclosed in US2019 / 0091490, for example, for the reduction of fat in subcutaneous tissue. Summary of the Invention

[0016] The present invention, in some embodiments, relates to the treatment of body tissue with energy, and more particularly, but not exclusively, to a device for the treatment of subcutaneous tissue by transcutaneously inducing ultrasonic vibrations in the subcutaneous tissue and / or transcutaneously delivering energy by electromagnetic radiation, such as light, to the subcutaneous tissue. In some embodiments, the treatment of the subcutaneous tissue is effective to reduce the amount of subcutaneous fat therein. In some embodiments, the transcutaneous radiation delivery of energy and the transcutaneous induction of ultrasonic vibrations in the subcutaneous tissue can be performed simultaneously, alternately, or in an unrelated manner. In some embodiments, the device simultaneously induces both transverse ultrasonic vibrations and longitudinal ultrasonic vibrations in the subcutaneous tissue.

[0017] [Device with a sonotrode having a conical section] According to an aspect of some embodiments of the present invention there is provided an apparatus suitable for treating subcutaneous tissue comprising: a. an ultrasonic transducer for generating ultrasonic vibrations having a proximal surface and a distal surface; b. a sonotrode having a sonotrode axis, comprising: i. a proximal surface in contact with and acoustically coupled to a distal surface of the ultrasound transducer; ii. a conical portion having a proximal end of a smaller radius and a distal end of a larger radius, the conical portion being defined by a conical wall having an outer conical surface and an inner conical surface, the inner conical surface at least partially defining a hollow; iii. a ring portion extending radially outward from the distal end of the conical portion having a ring-shaped proximal surface and a ring-shaped distal surface, the ring-shaped distal surface being the working surface of the sonotrode, the hole in the working surface defining a hollow open end.

[0018] In some embodiments, the device is configured to irradiate electromagnetic radiation onto a skin surface visible through the holes in the working surface of the sonotrode, the configuration for irradiation being such that the radiation comes from the hollow interior toward the hollow open end. As used herein, the skin surface visible through the holes in the working surface refers to the area of ​​the skin surface encompassed by the holes in the working surface of the sonotrode when the working surface is in contact with the skin surface.

[0019] In some embodiments, the ultrasonic transducer is a Langevin-type transducer including an axial bolt having a distal end and a proximal end. In some such embodiments, the axial bolt includes an axial passage between the distal end and the proximal end of the bolt. In some such embodiments, the axial passage provides fluid communication (e.g., of air) between the distal end and the proximal end of the bolt. Additionally or alternatively, in some embodiments, the axial passage provides optical communication (e.g., of electromagnetic radiation such as light) between the distal end and the proximal end of the bolt. Additionally or alternatively, in some embodiments, the axial passage provides a passage for a physical component (e.g., a waveguide such as a light guide, e.g., an optical fiber, a suction conduit, a material supply conduit) between the distal end and the proximal end of the bolt.

[0020] In some embodiments, the diameter of the holes in the working surface is between 10% and 70% of the diameter of the ring portion.

[0021] In some embodiments, the sonotrode further comprises a stem, the stem having a proximal face that is the proximal face of the sonotrode and a distal end that is the proximal end of the conical wall.

[0022] [Device with a hollow sonotrode] Some embodiments of the present invention relate to a hollow sonotrode having any shape with a hollow center. Thus, according to an aspect of some embodiments of the present invention, there is provided an apparatus suitable for treating subcutaneous tissue, comprising: a. an ultrasonic transducer for generating ultrasonic vibrations having a proximal surface and a distal surface; b. a sonotrode having a sonotrode axis, comprising: i. a proximal surface in contact with and acoustically coupled to a distal surface of an ultrasound transducer; ii. A hollow at the open end of the sonotrode; iii. a distal surface, said distal surface being the working surface of the sonotrode, the bore of the working surface defining a hollow open end. The hollow sonotrode comprises a sonotrode wall having an outer wall surface and an inner wall surface, the inner wall surface at least partially defining a hollow. In some embodiments, the working surface is ring-shaped.

[0023] In some such embodiments, a device having a sonotrode with a hollow is configured to irradiate electromagnetic radiation onto a skin surface visible through holes in the active surface of the sonotrode. The irradiation configuration is such that radiation is emitted from the hollow interior toward the open end of the hollow. The hollow may have any suitable shape. In preferred embodiments, the hollow has a cross-sectional area (perpendicular to the axis of the sonotrode) at its open end that is larger than the cross-sectional area (perpendicular to the axis of the sonotrode) at its proximal end (near the distal face of the transducer), such as the conical hollows described herein. Such a shape allows for a larger surface area of ​​skin to be irradiated at any one instant.

[0024] In addition to or as an alternative to a configuration for irradiating the skin, in some embodiments, the ultrasound transducer is a Langevin-type transducer including an axial bolt having a distal end and a proximal end. In some such embodiments, the axial bolt includes an axial passage between the distal end and the proximal end of the bolt. In some such embodiments, the axial bolt includes an axial passage between the distal end and the proximal end of the bolt. In some such embodiments, the axial passage provides fluid communication (e.g., of air) between the distal end and the proximal end of the bolt. Additionally or alternatively, in some embodiments, the axial passage provides optical communication (e.g., of electromagnetic radiation such as light) between the distal end and the proximal end of the bolt. Additionally or alternatively, in some embodiments, the axial passage provides a passage for a physical component (e.g., a waveguide such as a light guide, e.g., an optical fiber, a suction conduit, and / or a material supply conduit for the supply of a material such as a pharmaceutical or cosmetic treatment composition) between the distal end and the proximal end of the bolt.

[0025] [proximal channel] In some embodiments, in devices taught herein that include a sonotrode having a hollow core (whether or not it has a conical portion), the sonotrode further includes a proximal channel near the proximal end of the sonotrode, e.g., at the proximal face of the sonotrode, between the hollow core and the exterior of the sonotrode. In some such embodiments, the proximal channel provides fluid communication (e.g., of air) between the hollow core and the exterior of the sonotrode. Additionally or alternatively, in some embodiments, the proximal channel provides optical communication (e.g., of electromagnetic radiation such as light) between the hollow core and the exterior of the sonotrode. Additionally or alternatively, in some embodiments, the proximal channel provides passage of physical components (e.g., a waveguide such as a light guide, e.g., an optical fiber, a suction conduit, and / or a material supply conduit) between the hollow core and the exterior of the sonotrode. In some embodiments, the ultrasonic transducer is a Langevin-type transducer including an axial bolt having an axial passage between its distal and proximal ends, and the sonotrode has a bore for engaging the distal end of the axial bolt, such that the proximal channel of the sonotrode and the axial passage of the axial bolt together provide communication between the hollow of the sonotrode and the proximal end of the axial bolt.

[0026] In some embodiments, the communication is fluid communication (eg, air) between the hollow and the proximal end of the axial bolt.

[0027] Additionally or alternatively, in some embodiments, the communication then is optical communication (eg, of electromagnetic radiation such as light) between the hollow and the proximal end of the axial bolt.

[0028] Additionally or alternatively, in some such embodiments, the communication is the provision of a passage for a physical component (e.g., a waveguide such as a light guide, e.g., an optical fiber, a suction conduit, and / or a material supply conduit) between the hollow and the proximal end of the axial bolt.

[0029] Non-through-axis channel In some embodiments, in devices taught herein that include a sonotrode having a hollow (whether or not it has a conical portion and whether or not it has communication between the hollow and the proximal end of the axial bolt), the sonotrode includes a non-through-axis flow channel between the hollow and the outside of the sonotrode via the wall (e.g., the conical wall in some embodiments) whose inner surface defines the hollow and / or the stem, if present. In some embodiments, the non-through-axis channel provides fluid communication (e.g., of air) between the hollow and the outside. Additionally or alternatively, in some embodiments, the non-through-axis channel provides optical communication (e.g., of electromagnetic radiation such as light) between the hollow and the outside. Additionally or alternatively, in some such embodiments, the non-through-axis channel provides the passage of a physical component (e.g., a waveguide such as a light guide, e.g., an optical fiber, a suction conduit, a material supply conduit) between the hollow and the outside.

[0030] [Apply suction] In some embodiments, a device taught herein includes a sonotrode having a hollow center (whether or not it has a conical portion) configured to apply suction to a skin surface visible through holes in the working surface of the sonotrode. In some such embodiments, the device is operatively associated with a suction generator (e.g., a vacuum pump) and a conduit providing fluid communication between the hollow center and the suction generator, such that activation of the suction generator results in the evacuation of air from the hollow center through the channel: when the working surface contacts the skin surface, the evacuation of air from the hollow center by the suction generator results in a partial vacuum within the hollow center, thereby applying suction to the skin surface visible through the holes. In some embodiments, the operatively associated suction generator and / or conduit are components of the device. Alternatively, in some embodiments, the operatively associated suction generator and / or conduit are not components of the device.

[0031] In some such embodiments, the device is configured to allow application of suction to the skin surface visible through the holes in the working surface simultaneously with activation of the transducer to induce ultrasonic vibrations in the subcutaneous tissue.

[0032] Additionally or alternatively, in some such embodiments, the device is configured to allow application of suction to the skin surface visible through the holes in the working surface, alternating with activation of the transducer, to induce ultrasonic vibrations in the subcutaneous tissue.

[0033] Additionally or alternatively, in some such embodiments, the device is configured to allow application of suction to the skin surface visible through the holes in the working surface independent of activation of the transducer.

[0034] Configurations for operating such functions simultaneously, alternately, and / or independently will be apparent to those skilled in the art and may include one or more of switches, wiring, power sources, and appropriately configured controllers.

[0035] [irradiation] In some embodiments, devices taught herein that include a sonotrode having a hollow (whether or not it has a conical portion) are configured to deliver electromagnetic radiation to the skin surface visible through the holes in the working surface of the sonotrode.

[0036] As discussed in more detail below, in some such embodiments, the device is operatively associated with a radiation source that includes an aperture, which is in optical communication with the hollow (in some embodiments, via a waveguide). Activation of the radiation source results in illumination of the skin surface visible through the apertures in the active surface of the sonotrode with electromagnetic radiation from the radiation source. In some embodiments, the operatively associated radiation source and / or any waveguide are components of the device. Alternatively, in some embodiments, the operatively associated radiation source and / or any waveguide are not components of the device.

[0037] In some such embodiments, the device is configured to allow illumination of the skin surface visible through the holes in the working surface upon activation of the transducer to induce ultrasonic vibrations in the subcutaneous tissue.

[0038] Additionally or alternatively, in some such embodiments, the device is configured to allow illumination of the skin surface visible through the holes in the working surface, alternating with activation of the transducer, to induce ultrasonic vibrations in the subcutaneous tissue.

[0039] Additionally or alternatively, in some such embodiments, the device is configured to allow illumination of the skin surface visible through the holes in the working surface independent of activation of the transducer.

[0040] Configurations for operating such functions simultaneously, alternately, and / or independently will be apparent to those skilled in the art and may include one or more of switches, wiring, power sources, and appropriately configured controllers.

[0041] In some such embodiments, the device is configured for at least three functions, which are: allowing irradiation of the skin surface with electromagnetic radiation visible through the holes in the active surface of the sonotrode; allowing for the application of suction to the skin surface visible through the holes in the working surface; and Inducing ultrasonic vibrations in the subcutaneous tissue upon activation of the transducer.

[0042] In some embodiments, such devices are configured to allow simultaneous activation of at least two functions selected from the group consisting of: irradiating the skin surface; applying suction; and activating the transducer.

[0043] Additionally or alternatively, in some embodiments, such devices are configured to allow alternating activation of at least two functions selected from the group consisting of: irradiating the skin surface, applying suction, and activating the transducer.

[0044] Additionally or alternatively, in some embodiments, such devices are configured to allow independent actuation of at least two functions selected from the group consisting of: irradiating the skin surface, applying suction, and actuating the transducer.

[0045] Configurations for operating such functions simultaneously, alternately, and / or independently will be apparent to those skilled in the art and may include one or more of switches, wiring, power sources, and appropriately configured controllers.

[0046] In embodiments where the device is configured to irradiate the skin surface visible through the holes in the active surface of the sonotrode with electromagnetic radiation (whether or not it has a conical portion), the irradiation is electromagnetic radiation having a wavelength in any suitable range. In some embodiments, the range is selected from the group consisting of: ultraviolet light (having a wavelength in the range of 10-400 nm); Visible light (having a wavelength in the range of 400-750 nm); Infrared light (having a wavelength in the range of 750 nm to 15 μm); Terahertz waves (having wavelengths in the range of 10 μm to 1 mm (30 to 0.3 THz)); Microwaves (with wavelengths in the range of 1 mm to 1 m (300 GHz to 0.3 GHz)).

[0047] In embodiments configured for irradiation with UV light, preferred UV light is UV-C (100-280 nm), UV-B (280-315 nm) and / or UV-A (315-400 nm).

[0048] In embodiments configured for illumination with IR light, preferred IR light is NIR light (having a wavelength in the range of 750 nm to 1.4 μm); short IR light (having a wavelength in the range of 1.4 μm to 3 μm); mid-wave IR light (having a wavelength in the range of 3 μm to 8 μm); and long-wave IR light (having a wavelength in the range of 8 μm to 15 μm).

[0049] In some such embodiments, irradiating the skin surface visible through the perforations of the working surface with radiation comprises irradiating the skin surface visible through the perforations of the working surface with light (i.e., IR light, visible light, UV light).

[0050] The wavelength of the electromagnetic radiation is typically selected as a wavelength that has a useful effect on body tissue, such as wavelengths known in the art of percutaneous subcutaneous tissue treatment, for example light having 1060 nm.

[0051] In some embodiments, the device is configured so that radiation propagates axially from the proximal end of the hollow toward the open end of the hollow, working surface hole, hi some alternative embodiments, the device is configured so that radiation enters the hollow non-axially from a location other than the proximal end of the hollow.

[0052] In some embodiments, a device configuration for such irradiation includes a waveguide having a proximal end associated with a radiation source opening (the portion of the radiation source from which the radiation emerges), and a distal end of the waveguide leading to the hollow interior of the sonotrode, the waveguide providing optical communication from the radiation source to the hollow interior. As a result, radiation generated by a radiation source operatively associated with the proximal end of the waveguide is directed by the waveguide through the associated radiation source opening into the hollow interior of the sonotrode. In such embodiments, any radiation source having any dimensions can be used, as long as a suitable waveguide is present, and can be a component of a device as described herein. In some such embodiments, the radiation source is a component of the device. Alternatively, in some such embodiments, the radiation source is not a component of the device. As discussed in more detail below, in some embodiments, a portion of the waveguide passes through a component of the device (e.g., a transducer) parallel to the sonotrode axis and, in some such embodiments, enters the hollow interior at its proximal end. Alternatively, in some embodiments, a portion of the waveguide passes through a non-through-axis channel whose inner surface provides communication between the hollow and the outside of the sonotrode through a wall (which in some embodiments is a conical wall) that defines the hollow. For optical radiation, suitable waveguides include optical fibers and light pipes. For microwave and terahertz radiation, suitable waveguides are, for example, flexible, small-dimension waveguides such as dielectric waveguides or those available from Fairview Microwave, Inc. (Lewisville, Texas, USA).

[0053] Alternatively, in some embodiments, the configuration of the device for such irradiation is such that the device further comprises a radiation source and lacks a waveguide. In some such embodiments, the radiation source is disposed within the hollow. In some such embodiments, the radiation source is disposed within a physical component of the sonotrode. In some embodiments, the opening of the radiation source is directed into the hollow of the sonotrode. In some embodiments, the opening of the radiation source is directed into the hollow of the sonotrode from a proximal end of the hollow. Alternatively, in some embodiments, the opening of the radiation source is directed into the hollow of the sonotrode through a non-through-axis channel, the inner surface of which provides communication between the hollow and the outside of the sonotrode through a wall (which in some embodiments is a conical wall) defining the hollow. In some embodiments, radiation from the opening propagates parallel to the axis of the sonotrode. In some embodiments, radiation from the opening propagates non-parallel to the axis of the sonotrode.

[0054] [Radiation source] The radiation source may be any suitable radiation source, whether or not it is part of the device.

[0055] For photo-radiation (UV, visible, IR), any suitable photo-radiation source may be used. In some such embodiments, suitable light sources include lasers, such as diode lasers, solid-state lasers, or semiconductor lasers, for generating light of the desired wavelength. In some embodiments, suitable light sources comprise non-coherent light sources, such as LEDs, flash lamps (e.g., halogen lamps such as Xe or Kr), or other intense pulsed light (IPL) sources.

[0056] Any suitable microwave radiation source may be used for the microwave radiation, hi some such embodiments, a suitable radiation source comprises a magnetron, preferably a miniature magnetron (such as those available from Sunchonglic Co., Ltd., Guangdong, China), for generating microwave radiation of the desired wavelength.

[0057] Any suitable terahertz radiation source may be used for the terahertz radiation, hi some such embodiments, a suitable radiation source comprises a terahertz source, preferably a compact source for generating terahertz radiation having a desired wavelength, such as those available from TeraSense Group, Inc. of San Jose, Calif.

[0058] [Reflective surface] In some embodiments, at least a portion of the hollow interior surface (e.g., the inner conical surface) is configured to be reflective (diffusely and / or specularly reflective) to radiation; in some embodiments, at least 50%, at least 60%, at least 80%, and at least 90% of the hollow interior surface is reflective. In some embodiments, reflective means that the reflective portion of the surface has a reflectivity of at least 60% at normal incidence, more preferably at least 70%, at least 80%, at least 90%, or even at least 95% at normal incidence. In such embodiments, radiation that contacts the hollow interior surface is reflected, potentially irradiating the skin surface visible through the perforations in the working surface. One of ordinary skill in the art will be familiar with suitable materials for rendering the hollow interior surface of the sonotrode reflective to the desired degree for a particular wavelength of radiation, without undue experimentation. For example, in some embodiments, when the radiation is light, the inner surface of the hollow portion is made mirror-finished, for example, by polishing or coating the inner surface of an aluminum sonotrode, for example, by silvering, plating, vapor deposition, electron beam deposition, ion-assisted electron beam deposition of a reflective metal layer such as silver, and, if necessary, by coating with a protective layer to prevent the formation of a non-reflective oxide layer. In some embodiments, at least a portion of the portion of the inner surface of the hollow portion configured to be reflective is a silver mirror. Additionally or alternatively, in some embodiments, at least a portion of the portion of the inner surface of the hollow portion configured to be reflective is an aluminum mirror. That is, in preferred embodiments, the inner surface of the hollow portion is diffusely reflective.

[0059] [Optical elements] In embodiments in which the device is configured to irradiate the skin surface visible through the holes in the active surface of the sonotrode with electromagnetic radiation (whether or not it has a conical portion), the device further comprises at least one optical element that refracts the radiation. Typically, the optical element is configured to refract the radiation such that: directing at least a portion of the radiation into the hollow open end; directing at least a portion of the radiation away from the hollow interior surface; The radiation is distributed in the desired manner at the hollow open end. For example, in some embodiments, the optical element is configured to expand the beam of radiation from the radiation source so that it is more evenly distributed over the area of ​​the hollow open end, e.g., like a concave lens for light. For example, in some embodiments, the optical element is configured to change the direction of the beam of radiation from being directed toward the inner surface of the hollow to being directed toward the open end of the hollow. In some such embodiments, the optical element is within the hollow interior of the sonotrode and / or a physical component of the sonotrode. For optical radiation, suitable optical elements include lenses, prisms, and diffraction gratings. For microwave radiation, suitable optical elements include lens antennas such as retarding lenses, fast lenses, dielectric lenses, constrained lenses, Fresnel zone lenses, and Luneburg lenses. For terahertz radiation, suitable optical elements include terahertz lenses, such as those available from Menlo Systems GmbH of Planegg, Germany.

[0060] [Pulse-type ultrasound therapy device] According to aspects of some embodiments taught herein, there is also provided an apparatus for treating tissue with ultrasonic vibrations, the apparatus comprising: i. a sonotrode having an active surface; ii. an ultrasonic transducer operatively associated with the sonotrode; iii. an ultrasonic power supply operatively associated with the ultrasonic transducer and configured to provide an alternating current (AC) oscillating at an ultrasonic drive frequency to drive the ultrasonic transducer; iv. a controller configured to receive user commands to vibrate the working surface at ultrasonic frequencies, and following receipt of such commands, to operate other components of the device to ultrasonically vibrate the working surface periodically at a rate of at least two pulses per second, each pulse having a duration of less than 250 milliseconds, and any two pulses separated by a rest phase of at least 10 milliseconds; Equipped with.

[0061] According to aspects of some embodiments taught herein, there is also provided a method for treating tissue with ultrasonic vibrations, the method comprising: acoustically coupling the active surface of the sonotrode with the tissue surface; cyclically vibrating the working surface at an ultrasonic frequency at a rate of at least two pulses (of ultrasonic vibrations) per second for the duration of the treatment, each pulse having a duration of less than 250 milliseconds, and any two pulses separated by a rest phase of at least 10 milliseconds; Including, Here, the intensity of the pulse and the duration of treatment are sufficient to achieve the desired results. [Brief explanation of the drawings]

[0062] Some embodiments of the present invention are described herein with reference to the accompanying drawings. The description, together with the drawings, makes apparent to those skilled in the art how some embodiments of the present invention may be implemented. The drawings are for illustrative purposes and no attempt is made to show structural details of the embodiments in more detail than is necessary for a fundamental understanding of the present invention. For clarity, some items shown in the drawings are not drawn to scale.

[0063] [Figure 1] 1 (Prior Art) shows a schematic of an apparatus for applying ultrasonic vibrations to a medium through its surface. [Figure 2A] (Prior Art) Schematic of a sonotrode (linear tapered sonotrode) configured to function as an acoustic amplitude transducer. [Figure 2B]1 (Prior Art) shows a schematic of a sonotrode (exponentially tapered sonotrode) configured to function as an acoustic amplitude transducer; [Figure 2C] FIG. 1 (Prior Art) shows a schematic of a sonotrode (a stepped tapered sonotrode) configured to function as an acoustic amplitude transducer. [Figure 2D] (Prior Art) Schematic of a sonotrode (a mushroom tapered sonotrode according to US2011 / 0213279) configured to function as an acoustic amplitude transducer. [Figure 3] FIG. 1 shows a schematic diagram of an embodiment of a sonotrode according to (Prior Art) US2019 / 0091490. [Figure 4A] FIG. 1 is a side view of a device, schematically illustrating a device and sonotrode according to one embodiment taught herein configured for application of suction to a skin surface. [Figure 4B] 1 is a side view of a sonotrode, schematically illustrating an apparatus and sonotrode according to one embodiment taught herein configured for application of suction to a skin surface. FIG. [Figure 4C] 1 is a side cross-sectional view of a sonotrode, schematically illustrating an apparatus and sonotrode according to one embodiment taught herein configured for application of suction to a skin surface. FIG. [Figure 4D] FIG. 1 is a perspective view of a sonotrode viewed from the bottom toward the working surface, schematically illustrating an apparatus and sonotrode according to one embodiment taught herein configured for application of suction to a skin surface. [Figure 5] 1 illustrates a schematic diagram of an embodiment of a sonotrode according to an embodiment taught herein configured for irradiating skin with radiation, and in particular for irradiating skin with light. [Figure 6] 1 illustrates a schematic diagram of an embodiment of a sonotrode according to one embodiment of the teachings herein. [Figure 7] 1 illustrates a schematic diagram of one embodiment of a sonotrode in accordance with the teachings herein configured for application of suction to a skin surface. [Figure 8A]FIG. 1 is a side view of a device that schematically illustrates one embodiment of a device according to the teachings herein that is configured for both irradiating skin with radiation, specifically irradiating skin with light, and applying suction to the skin surface. [Figure 8B] FIG. 1 is a side cross-sectional view of a sonotrode of a device that schematically illustrates one embodiment of a device according to the teachings herein configured for both irradiating skin with radiation, specifically irradiating skin with light, and applying suction to the skin surface. [Figure 9A] 1 illustrates a schematic side cross-sectional view of one embodiment of an apparatus according to the teachings herein configured for irradiating skin with radiation. [Figure 9B] 1 illustrates a schematic side cross-sectional view of one embodiment of an apparatus according to the teachings herein configured for irradiating skin with radiation. [Figure 10A] 1 illustrates schematically one embodiment of an apparatus suitable for treating tissue with ultrasonic vibrations. [Figure 10B] 1 illustrates schematically one embodiment of an apparatus suitable for treating tissue with ultrasonic vibrations. DETAILED DESCRIPTION OF THE INVENTION

[0064] The present invention, in some embodiments, relates to the treatment of body tissue with energy, and more particularly, but not exclusively, to a device for treating subcutaneous fat by transcutaneously inducing ultrasonic vibrations in the subcutaneous tissue and / or transcutaneously delivering energy by electromagnetic radiation, such as light, to the subcutaneous tissue. In some embodiments, the treatment of the subcutaneous tissue is effective to reduce the amount of subcutaneous fat therein. In some embodiments, the transcutaneous radiation delivery of energy and the transcutaneous induction of ultrasonic vibrations in the subcutaneous tissue can be performed simultaneously, alternately, or in an unrelated (independent) manner. In some embodiments, the device simultaneously induces both transverse ultrasonic vibrations and longitudinal ultrasonic vibrations in the subcutaneous tissue.

[0065] The principles, applications, and implementations of the teachings herein may be better understood by reference to the accompanying description and figures. Upon perusal of the description and figures presented herein, one skilled in the art will be able to practice the invention without undue effort or experimentation. In the figures, like reference numerals refer to like parts throughout.

[0066] Before describing at least one embodiment in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of components and / or methods described herein. The invention is capable of other embodiments or of being practiced or carried out in various ways. The phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0067] As noted above, in Patent Publication US2019 / 0091490, some of the inventors disclose a sonotrode that they have found to be particularly effective for treating subcutaneous tissue. The inventors believe that the effectiveness of the sonotrode is at least in part due to the sonotrode simultaneously inducing both transverse and longitudinal ultrasonic vibrations in the subcutaneous tissue to acoustically energize and treat the tissue.

[0068] Until recently, the inventors believed that simultaneously inducing both ultrasonic transverse and longitudinal vibrations at sufficient intensity so that the two modes provide substantial energy balanced to achieve the desired biological effect was only possible with sonotrodes constructed according to the teachings of US2019 / 0091490.

[0069] Disclosed herein is a device for treating subcutaneous tissue, and a method of using the device, that includes a sonotrode having a conical portion and a ring-shaped working surface. It has surprisingly been discovered that devices according to such embodiments of the teachings herein are particularly effective for treating subcutaneous tissue. Without wishing to be bound by any one theory, it is presently believed that their effectiveness is at least partially attributable to the sonotrode simultaneously inducing both transverse and longitudinal ultrasonic vibrations in the subcutaneous tissue to acoustically deliver energy to treat the tissue. Although the presently disclosed sonotrode is quite different from the sonotrode of US 2019 / 0091490, it is presently believed that both induced modes of vibration are sufficiently intense to deliver substantial energy to achieve a desired biological effect, e.g., substantial heating of tissue and substantial destruction of fat cells, in a manner comparable to and even exceeding that of the device disclosed in US 2019 / 0091490.

[0070] A challenge in operating devices according to the teachings of US 2019 / 0091490 is that the longitudinal waves generated by the ultrasonic transducer increase the temperature of the central portion of the sonotrode's working surface. This temperature may rise to a level that can cause discomfort or injury to the subject being treated. As a result, operators of such devices must be particularly careful when using the device to limit the power of the ultrasonic vibrations generated by the transducer to reduce the degree of heating of the working surface and to avoid discomfort or injury to the subject being treated. In contrast, the ring-shaped working surface of the sonotrode of devices taught herein does not suffer from such heating because it does not have a central portion, only holes. Some embodiments of the devices and sonotrodes disclosed herein have additional advantages, as disclosed below.

[0071] According to an aspect of some embodiments of the present invention there is provided an apparatus suitable for treating subcutaneous tissue comprising: a. an ultrasonic transducer for generating ultrasonic vibrations having a proximal surface and a distal surface; b. a sonotrode having a sonotrode axis, comprising: i. a proximal surface in contact with and acoustically coupled to a distal surface of the ultrasound transducer; ii. a conical portion having a proximal end of a smaller radius and a distal end of a larger radius, the conical portion being defined by a conical wall having an outer conical surface and an inner conical surface, the inner conical surface at least partially defining a hollow; iii. a ring portion extending radially outward from the distal end of the conical portion having a ring-shaped proximal surface and a ring-shaped distal surface, the ring-shaped distal surface being the working surface of the sonotrode, the hole in the working surface defining a hollow open end.

[0072] This and additional aspects of the teachings herein are described in the Abstract section, two of which relate to an apparatus including an ultrasonic transducer and sonotrode with a hollow open end, and an apparatus including a transducer with a hollow axial bolt. As will be apparent to those skilled in the art, the detailed description and figures herein describe the components and operation of this aspect of the teachings herein.

[0073] An exemplary embodiment of a device 72 according to the teachings herein is shown generally in Figures 4A-4D: 4A (side view of device 72 with ultrasonic transducer 12 and sonotrode 74), 4B (side view of sonotrode 74), 4C (cross-sectional side view of sonotrode 74), and 4D (bottom perspective view of sonotrode 74). Device 72 is configured to induce ultrasonic vibrations transcutaneously into subcutaneous tissue through the working surface of sonotrode 74 when transducer 12 is activated in conjunction with simultaneous, alternating, or independent application of suction through holes in the working surface, as described in more detail below.

[0074] The ultrasonic transducer 12 has a proximal face 14 and a distal face 18. The ultrasonic transducer 12 is a Langevin-type (between 45 N / m and 100 N / m) prestressed transducer including a stack of four 6 mm diameter discs configured to generate ultrasonic longitudinal frequencies between 56 kHz and 60 kHz, and is held together with an acoustic reflector 16 and a sonotrode 74 by an axial bolt 75.

[0075] The sonotrode 74 has a sonotrode axis 28, which is: i. a proximal face 56 in contact with and acoustically coupled to the distal face 18 of the ultrasound transducer 12; ii. a conical portion 76 having a proximal end 78 with a smaller radius and a distal end 80 with a larger radius, the conical portion 76 being defined by a conical wall 82 having an outer conical surface 84 and an inner conical surface 86, the inner conical surface 86 at least partially defining a hollow 88; iii. A ring portion 90 extending radially outward from the distal end 80 of the conical portion 76, the ring portion 90 having a ring-shaped proximal surface 92 and a ring-shaped distal surface that is the working surface 94 of the sonotrode 74 and device 72, the hole 96 in the working surface 94 forming the open end of the hollow 88.

[0076] [Sonotrode materials] The sonotrode 74 is a monolithic block of aluminum 6061 (an alloy of aluminum with magnesium and silicon as alloying elements) so that all components are integrally formed. The working surface 94 of the sonotrode 74 includes a 10 μm thick soft anodized layer.

[0077] [Ring part] The ring portion has a ring-shaped proximal surface (92 in FIG. 4), a ring-shaped distal surface (94 in FIG. 4) which is the working surface of the sonotrode, and a peripheral wall (98 in FIG. 4).

[0078] In a preferred embodiment, the shape of the ring portion of the sonotrode is circular (when viewed parallel to the sonotrode axis), preferably centered about the sonotrode axis. The outer periphery of the ring portion 90 of the sonotrode 74 is circular when viewed parallel to the sonotrode axis 28. In some alternative embodiments, the ring portion has a different shape, such as an ellipse or an oval.

[0079] In preferred embodiments, the diameter of the ring portion (the largest dimension of the ring portion perpendicular to the sonotrode axis) is between 20 mm and 300 mm (and in some embodiments up to 200 mm), and is typically selected based on, among other things, the intended use (which part of the body is to be treated; arms are preferably treated with a smaller diameter ring portion, thighs are preferably treated with a larger diameter ring portion) and the selected drive frequency, as described below. The ring portion 90 of the sonotrode 74 has a diameter of 90 mm.

[0080] In preferred embodiments, at least 80%, or even at least 90%, of the surface area of ​​the working surface is perpendicular to the sonotrode axis. In FIG. 2, 90% or more of the working surface 94 of sonotrode 74 is perpendicular to sonotrode axis 28, with only a small peripheral portion near its intersection with peripheral wall 98 curving upward in the proximal direction to avoid scratching, injuring, or causing discomfort to the person being treated. In some alternative embodiments, less than 90% of the working surface is perpendicular to the sonotrode axis. In some such alternative embodiments, a portion (at least 20%, at least 30%, at least 50%, or even at least 70%) of the working surface is convexly curved in the proximal direction, such that the ring portion has a convex lens shape in a cross section parallel to the sonotrode axis. In some such alternative embodiments, a portion of the working surface (at least 20%, at least 30%, at least 50%, or even at least 70%) is flat but not parallel to the sonotrode axis, such that in cross section (when viewed perpendicular to the sonotrode axis) a portion of the working surface is straight.

[0081] In preferred embodiments, at least 90% of the surface area of ​​the proximal surface is perpendicular to the sonotrode axis. 100% of the proximal surface 92 of the sonotrode 74 is perpendicular to the sonotrode axis 28. In some alternative embodiments, less than 90% of the proximal surface is perpendicular to the sonotrode axis. In some such alternative embodiments, a portion (at least 20%, at least 30%, at least 50%, or even at least 70%) of the proximal surface is convexly curved distally, such that in a cross section perpendicular to the sonotrode axis, the ring portion has a lenticular shape. In some such alternative embodiments, a portion (at least 20%, at least 30%, at least 50%, or even at least 70%) of the proximal surface is flat, but not parallel to the sonotrode axis, such that in cross section (when viewed perpendicular to the sonotrode axis), a portion of the proximal surface is straight.

[0082] In some embodiments, the intersection of the working surface and the peripheral wall is not curved. Alternatively, in some preferred embodiments, the intersection of the working surface and the peripheral wall is curved to reduce the chance of scraping or scratching the skin surface during use. In sonotrode 74, the intersection of working surface 94 and peripheral wall 98 is curved.

[0083] In some embodiments, the intersection of the proximal surface with the peripheral wall is not curved. Alternatively, in some preferred embodiments, the intersection of the proximal surface with the peripheral wall is curved. In sonotrode 74, the intersection of proximal surface 92 with peripheral wall 98 is 90° and not curved.

[0084] In some embodiments, at least a portion of the peripheral wall is parallel to the sonotrode axis, preferably at least 20%, at least 30%, at least 40%, or even at least 50% of the peripheral wall is parallel to the sonotrode axis. In sonotrode 74, 60% of the peripheral wall 98 is parallel to the sonotrode axis 28. In some embodiments, a central portion of the peripheral wall is parallel to the sonotrode axis. In sonotrode 74, the central portion of the peripheral wall 98 is parallel to the sonotrode axis 28. In some alternative embodiments, the central portion of the peripheral wall is not parallel to the sonotrode axis. In some such alternative embodiments, the central portion of the peripheral wall is curved (e.g., the entire peripheral wall is curved). In such alternative embodiments, the central portion of the peripheral wall is straight and not parallel to the sonotrode axis, such that the diameter of the proximal face is larger than the diameter of the distal face, or the diameter of the distal face is larger than the diameter of the proximal face.

[0085] In some preferred embodiments, at least 70%, at least 80%, or even at least 90% of the surface area of ​​the working and proximal faces are parallel (and preferably perpendicular to the sonotrode axis). In such embodiments, the thickness of the working faces (the dimension parallel to the sonotrode axis) measured at the parallel portion is any suitable thickness, preferably at least 1 mm and no more than 10 mm. In some embodiments, to enhance the robustness of the ring portion, the thickness is at least 2 mm, or even at least 3 mm. In some embodiments, the thickness is no more than 8 mm, or even no more than 7 mm. In sonotrode 74, at least 90% of the surfaces of the working and proximal faces 94 and 92 are parallel, and the thickness of the ring portion is 5 mm. In some alternative embodiments, less than 70% of the surface area of ​​the working and proximal faces is parallel, for example, when one or both faces are curved and / or one or more faces are flat but not parallel. In such alternative embodiments, the thickness of the ring portion at its thickest and thinnest portions is preferably at least 1 mm and no more than 20 mm (and in some embodiments no more than 10 mm), where the difference between the thickness of the thickest portion and the thickness of the thinnest portion is no more than 7 mm, no more than 5 mm, no more than 3 mm, no more than 2 mm, or even no more than 1 mm.

[0086] [Hole on working surface] The working surface is ring-shaped with holes defining the open ends of the hollow. In some instances where a sonotrode is used, the working surface contacts the ring-shaped portion of the skin surface and can induce vibrations in the subcutaneous tissue in the usual manner. Different portions of the skin surface encompassed by the ring-shaped portion of the skin surface are visible through the holes in the working surface of the sonotrode, and different portions of the skin close off the hollow from fluid communication with the outside air.

[0087] In a preferred embodiment, the shape of the holes is circular (when viewed parallel to the sonotrode axis), and preferably centered on the sonotrode axis. The shape of the holes 96 in the ring portion 90 of the sonotrode 74 is circular when viewed parallel to the sonotrode axis 28. The holes 96 in the sonotrode 74 are centered on the sonotrode axis 28. In some alternative embodiments, the holes have a different shape, such as an ellipse or oval, and / or are not centered on the sonotrode axis.

[0088] In a preferred embodiment, the hole diameter (the hole's largest dimension perpendicular to the sonotrode axis) is between 10% and 70% of the diameter of the ring portion, more preferably between 20% and 50%, and even more preferably between 25% and 40%. The hole 96 in the sonotrode 74 is circular with a diameter of 30 mm, which is 33% of the 90 mm diameter of the ring portion 90.

[0089] [Conical surface and hollow] A sonotrode according to the teachings herein has a conical portion having a proximal end of a smaller radius and a distal end of a larger radius, the conical portion being defined by a conical wall having an outer conical surface and an inner conical surface, the inner conical surface at least partially defining a hollow. As is apparent from this description, the conical portion is a hollow conical portion, i.e., has a hollow, the hollow being at least partially defined by the inner conical surface.

[0090] In preferred embodiments, the outer and inner conical surfaces are parallel, resulting in a constant conical wall thickness. In such embodiments, the conical wall thickness is any suitable thickness, typically between 2 mm and 10 mm, and in some preferred embodiments, between 2 mm and 6 mm. In sonotrode 74, outer and inner conical surfaces 84 and 86 are parallel, and conical wall 82 has a constant thickness of 3.3 mm. In some alternative embodiments, the outer and inner surfaces are not parallel, and the conical wall thickness is not constant. In such preferred alternative embodiments, the conical wall thickness varies within a range of 2 mm to 10 mm, preferably with the more proximal portion being thicker than the more distal portion.

[0091] The cone angle of the inner surface may be any suitable angle. In a preferred embodiment, when the hole is circular in shape and the inner surface defines a portion of a right circular cone, there is a single cone angle, preferably between 70° and 95°, more preferably between 75° and 90°, and even more preferably between 78° and 86°. In sonotrode 74, hole 96 is circular and inner surface 86 defines a right circular cone, so there is a single cone angle 100 of 82°. In some alternative embodiments, for example, when the hole is not circular in shape, e.g., elliptical or oval, or when the inner surface defines a portion of an oblique cone, there are multiple cone angles ranging from a minimum cone angle to a maximum cone angle. In preferred such alternative embodiments, both the minimum and maximum cone angles are between 70° and 95°. In a preferred embodiment, the inner surface defines a portion of a right circular cone, where the line between the (imaginary) apex of the cone and the center of the hole is perpendicular to the plane of the hole (whether the hole is circular or not). In some embodiments, the inner surface defines a portion of a cone that is not a right circular cone: in such embodiments, the angle between the (imaginary) apex of the cone and the line between the center of the hole is close to vertical (90°), preferably 70° or more, 75° or more, 80° or more, or even 85° or more.

[0092] In some embodiments, the conical inner surface extends to the working surface and defines the bore of the sonotrode. In sonotrode 74, conical inner surface 86 extends to working surface 94, thereby defining bore 96. In some alternative embodiments, the distal portion of the inner surface is not conical. In some such embodiments, the distal portion of the inner surface that defines the interior of the ring portion is parallel to the sonotrode axis.

[0093] In some embodiments, the inner conical surface is a perfect cone terminating in a pointed or curved apex. In such embodiments, the hollow portion defined by the inner conical surface is a true cone (see FIGS. 6 and 7). In an alternative embodiment, the inner conical surface and the hollow portion defined by the inner conical surface are truncated cones. In sonotrode 74, conical inner surface 86 and the hollow portion 88 defined by conical inner surface 86 are truncated right cones. The height of the hollow portion defined by the conical inner surface (the dimension parallel to the sonotrode axis) can be any suitable height and is determined by the dimensions of other features of the sonotrode. In sonotrode 74, the height of hollow portion 88 defined by conical inner surface 86 is 12 mm.

[0094] In some embodiments where the inner cone surface and the hollow portion defined by the inner cone surface are truncated cones, there is a proximal hollow wall perpendicular to the working surface so that at least a portion of the hollow is a true truncated cone. Alternatively, in some embodiments, the hollow portion above the proximal end of the cone inner surface is any suitable shape. In sonotrode 74, the portion of hollow 88 above the proximal end of cone inner surface 86 is proximal portion 102. Proximal portion 102 of hollow 88 is a generally cylindrical volume with curved edges that has a diameter (dimension perpendicular to sonotrode axis 28) of 7 mm and a height (dimension parallel to sonotrode axis 28) of 5 mm.

[0095] [Stem] As mentioned above, the sonotrode has a proximal face that contacts and is acoustically coupled to the distal face of the ultrasound transducer.

[0096] In some embodiments, the proximal end of the conical wall defines the proximal face of the sonotrode.

[0097] In a preferred embodiment, the sonotrode comprises a stem, the stem having a proximal face that is the proximal face of the sonotrode and a distal end that is the proximal end of the conical wall. The sonotrode 74 comprises a stem 104 that includes the proximal face 56 of the sonotrode 74 and a distal end that is the proximal end 78 of the conical wall 82. As is known in the sonotrode art, in cross section (perpendicular to the sonotrode axis), the stem is preferably circular, although in cross section, in some embodiments, the stem has a different shape, for example, elliptical or oval.

[0098] Typically, the stem has one or more features that allow it to acoustically couple the sonotrode to the transducer. In sonotrode 74, stem 104 includes a 10 mm diameter threaded hole 106 configured to mate with axial bolt 75. When device 72 is assembled in the usual manner for Langevin-type transducers, reflector 16, transducer 12 components, and sonotrode 74 are threaded onto bolt 75. Bolt 75 is tightly threaded (e.g., with a torque of 45-100 N / m) into threaded hole 106 to compress the components together to ensure contact and acoustic coupling, as is known in the art of Langevin-type transducers.

[0099] In the art, the axial bolt of a Langevin-type transducer is a conventional solid bolt that has the necessary mechanical properties to compress the transducer components together under conditions of ultrasonic vibration and associated heating. In some embodiments of the teachings herein, the axial bolt includes an axial passageway (e.g., fluid communication such as air, passageway for physical components, and / or optical communication for light) between the proximal and distal ends of the bolt. In preferred embodiments, the axial passageway is collinear with the axis of the sonotrode. Alternatively, in some embodiments, the axial passageway is parallel to the sonotrode axis but not collinear with the sonotrode axis. Alternatively, in some embodiments, the axial passageway is not parallel to the sonotrode axis. The usefulness of such axial passageways is discussed later in this specification. In sonotrode 74, axial bolt 75 includes axial passageway 108 that is collinear with sonotrode axis 28. In some embodiments, the axial bolt includes one or more axial passages, e.g., two, three, or more axial passages that are typically not in fluid communication with each other, e.g., the two, three, or more axial passages, in some embodiments, are all parallel to the sonotrode axis.

[0100] In embodiments that include a stem, the stem can have any suitable shape. In a preferred embodiment, the sonotrode and stem are configured together to function as an acoustic amplitude transducer for a selected ultrasonic frequency. In such embodiments, any stem and sonotrode configuration known in the art for configuring a sonotrode to function as an acoustic amplitude transducer for a selected ultrasonic frequency can be used, including having a tapered stem as described in the introduction with reference to Figures 2A-D.

[0101] The sonotrode 74 is configured to function as an acoustic amplitude transducer for a selected ultrasonic frequency by configuring the stem 104 as a stepped, tapered stem (see FIGS. 2C and 2D). Specifically, the stem 104 of the sonotrode 74 includes a wide-diameter proximal stem portion 52 having a diameter of 42 mm, which is the diameter of the distal face 18 of the transducer 12. The proximal stem portion 52 carries the proximal face 56 (also referred to as the "input face") of the sonotrode 74. The stem 104 further includes a narrow-diameter distal stem portion 110 having a diameter of 14 mm. The transition from the proximal stem portion 52 to the distal stem portion 110 is not abrupt; rather, the edges and transition are rounded to increase mechanical strength and to avoid sharp edges that could injure or injure the operator.

[0102] The length (axial dimension) of the sonotrode 72 is 50 mm. The length of the proximal stem portion 52 is 24 mm, which is 48% of the length of the sonotrode 72. The length of the distal stem portion 110 (length from the distal end of the proximal stem portion 52 to the proximal end 78b of the conical wall 82) is 13.2 mm. As known to those skilled in the art, in the case of a stepped tapered stem of the sonotrode, it is advantageous for the wide-diameter proximal stem portion to be 45% to 55% of the length of the sonotrode, preferably 46% to 54%, and more preferably 47% to 53%.

[0103] [Use of sonotrodes for subcutaneous tissue treatment] As known in the art and described in the introduction, for use of the sonotrode of the present teachings to treat subcutaneous tissue, the working surface is acoustically coupled to the skin surface (e.g., by direct contact with the skin or by indirect contact via a coupling substance, e.g., a liquid or gel). An alternating current oscillating at an ultrasonic driving frequency is supplied from an ultrasonic power source (e.g., power source 34 in FIG. 4A ) to drive the ultrasonic transducer. The transducer generates ultrasonic longitudinal vibrations at the driving frequency. The generated longitudinal vibrations propagate through the sonotrode to the working surface. Without wishing to be bound by any one theory, the generated longitudinal vibrations pass through the stem and the conical wall, causing the working surface to vibrate in both longitudinal and some transverse vibrations (e.g., shear waves, Lamb waves). The ultrasonic vibrations of the working surface induce both ultrasonic longitudinal and transverse vibrations in the subcutaneous tissue transcutaneously, thereby treating the tissue.

[0104] The driving frequency may be any suitable ultrasonic frequency, preferably between 30 kHz and 200 kHz, more preferably between 40 kHz and 100 kHz, and even more preferably between 40 kHz and 80 kHz. However, if a given sonotrode is driven at any driving frequency, the transcutaneous induction of subcutaneous vibrations may result in a longer, less efficient, less comfortable, and / or less effective treatment of the subject.

[0105] In some preferred embodiments, the sonotrode is configured to operate at at least one selected ultrasonic drive frequency, and the ultrasonic transducer is configured to generate the selected drive frequency when driven by a drive current alternating at the selected drive frequency.

[0106] In some embodiments, being configured to operate at a selected ultrasonic drive frequency means that the sonotrode is configured to function as an acoustic amplitude transducer for the selected ultrasonic frequency, for example, by including a tapered stem as described above.

[0107] Alternatively, or preferably in addition, in some embodiments, the configuration operating at the selected ultrasonic drive frequency is such that the length of the sonotrode from the proximal surface (56) to the working surface (94) is: nλ longitudinal / 2 where n is a positive integer greater than 0; and λ longitudinal is the wavelength of the ultrasonic longitudinal waves in the sonotrode and is determined primarily by the material from which the sonotrode is made. The length of the sonotrode 74 is 50 mm. In some embodiments, the length of the sonotrode is set based on the longitudinal speed of sound through the sonotrode at room temperature (25°C). In some alternative embodiments, the length of the sonotrode is set based on the longitudinal speed of sound through the sonotrode up to the expected operating temperature (e.g., 36°C-40°C).

[0108] Alternatively, or preferably in addition, the configuration for operation at the selected ultrasonic drive frequency comprises a ring portion (90) having a diameter of: nλ transverse / 2 where n is a positive integer greater than 0; and λ transverse is the wavelength of the ultrasonic shear waves in the sonotrode and is determined primarily by the material from which the sonotrode is made. The diameter of the ring portion 90 of the sonotrode 74 is 90 mm. In some embodiments, the diameter of the ring portion is set based on the transverse velocity of sound through the sonotrode at room temperature (25°C). In some alternative embodiments, the diameter of the ring portion is set based on the transverse velocity of sound through the sonotrode up to the expected operating temperature (e.g., 36°C to 40°C).

[0109] Typically, someone designing a particular sonotrode in accordance with the teachings herein first determines the approximate desired sonotrode dimensions and material from which the sonotrode will be made that are practical and convenient for an operator to handle and that are suitable for treating a particular area of ​​the body (e.g., abdomen, thigh, face, submental). In a preferred embodiment, the sonotrode length is between 20 mm and 200 mm, and the ring portion diameter is between 20 mm and 200 mm. The designer then selects the desired selected drive frequency based, for example, on regulatory requirements, cost, or power supply / transducer availability. Once the selected drive frequency is selected, the designer can specify the exact sonotrode length and ring portion diameter that approximates the approximate desired sonotrode dimensions.

[0110] [proximal channel] In some embodiments, a sonotrode according to the teachings herein further comprises a proximal channel between the hollow and the outside of the sonotrode near the proximal face of the sonotrode, in preferred embodiments, between the hollow and the proximal face of the sonotrode. In some embodiments, the proximal channel provides fluid communication (e.g., of air or other fluids) between the hollow near the proximal end of the sonotrode and the outside. Alternatively or additionally, in some embodiments, the proximal channel provides passage of a physical component (e.g., a waveguide, such as a light guide, like an optical fiber) between the hollow and the outside. As described in more detail below, in some embodiments, the proximal channel is configured to connect to a suction generator, such as a vacuum pump, allowing for the application of suction through the proximal channel to evacuate air from the hollow during operation of the device. In some embodiments, the proximal channel is configured to allow the passage of a waveguide, such as a light guide, like an optical fiber, allowing for illumination of the skin surface with light visible from inside the hollow through the holes in the working surface of the sonotrode.

[0111] 4C, sonotrode 74 includes three-section proximal channels, collectively numbered 112, that are coaxial with axis 28 and provide fluid communication between proximal portion 102 of hollow 88 and proximal face 56 of sonotrode 74. Along its entire length, proximal channel 112 has a circular cross-section: a 1 mm diameter x 3.1 mm long distal portion 112a; a 3 mm diameter x 11.1 mm long intermediate portion 112b; and a 1.8 mm long conical proximal section 112c that widens from a 3 mm diameter at the transition from the intermediate section 112b to 10 mm at the transition to the threaded bore 106; Includes:

[0112] [Proximal channel for applying suction] In some embodiments, the device is configured to apply suction to the skin surface through holes in the working surface of the sonotrode by evacuating air from the hollow during operation of the device. In some such embodiments including a proximal channel, the proximal channel is configured to be connected to a suction generator, such as a vacuum pump, and the proximal channel allows activation of the suction generator to evacuate air from the hollow during operation of the device.

[0113] The device 72 shown in FIG. 4 is configured to apply suction to the skin surface through a hole in the working surface during operation by including a connector 114 (see FIG. 4A ) that can connect the proximal channel 112 to a suction generator, such as a vacuum pump, via the axial passage 108 in the axial bolt 75. The device 72 is further configured to apply suction to the skin surface by including a 14 mm diameter, 2 mm deep cylindrical hole 116 in the proximal face 56 of the sonotrode 74 that is coaxial with the axis 28. When the transducer 12 and sonotrode 74 are held together by the axial bolt 75, an appropriately sized silicone rubber O-ring (not shown) seats within the hole 116 and compresses against the walls of the hole 116, the outer surface of the axial bolt 75, and the distal face 18 of the transducer 12, creating an airtight seal that prevents air from escaping from the transducer / sonotrode interface. The hole 116 can be arbitrarily considered to be the most proximal portion of the proximal channel 112.

[0114] For use, the device 72 is prepared in the usual manner known in the sonotrode art, including operatively associating the transducer 12 with the power source 34 and connecting the connector 114 to a suction generator (not shown), such as a Venturi pump. A lubricant, such as mineral oil, is applied to the area of ​​skin to be treated. The power source 34 and suction generator are activated, and the working surface 94 is brought into contact with the surface of the skin to be treated in a continuous reciprocating or circular motion, as is known in the art of percutaneous subcutaneous tissue treatment. The suction generator draws air from the hollow 88 through the connector 114, the axial passage 108 in the bolt 75, the proximal channel portion 112c, the intermediate channel portion 112b, and the distal channel portion 112a, generating a low pressure within the hollow 88, typically such that the pressure within the hollow 88 is less than 525 mmHg (70 kPa), preferably less than 450 mmHg (60 kPa) but greater than 100 mmHg (13.4 kPa), or even greater than 200 mmHg (27 kPa). In some preferred embodiments, the pressure within the hollow 88 is between 200 mmHg (27 kPa) and 300 mmHg (40 kPa). In some alternative preferred embodiments, the pressure within the hollow 88 is between 250 mmHg (33 kPa) and 350 mmHg (47 kPa), e.g., about 300 mmHg (40 kPa). As a result of the lower pressure within hollow 88, working surface 94 has better contact with the skin being treated, thereby more efficiently and consistently inducing ultrasonic vibrations into the subcutaneous tissue. Furthermore, the suction applied to the area of ​​skin located at hole 96 while sonotrode 74 is moving has a pleasant massaging effect that increases the subject's desire to be treated and is believed to improve blood circulation in the treated area of ​​the subcutaneous tissue, thereby increasing the removal of harmful factors released into the tissue and increasing the effectiveness of the treatment and the rate of healing.

[0115] Device 72 has been constructed, tested, and proven to be successful in treating subcutaneous tissue. Specifically, jowls (sagging skin under the chin and jawline) in human female subjects aged 50 years or older were treated using Device 72 by transcutaneously inducing ultrasonic vibrations to the jowls and simultaneously applying a vacuum (300 mmHg) through the hollow. After three 10-minute sessions per week, the jowls were no longer noticeable.

[0116] [Proximal channel for irradiating the skin visible through the hole in the working surface] In some embodiments, the device is configured to irradiate the skin surface visible through the holes in the working surface of the sonotrode with radiation, e.g., to irradiate the skin surface visible through the holes in the working surface of the sonotrode with treatment light. In some such embodiments including a proximal channel, the proximal channel is configured to allow passage of a radiation waveguide (e.g., a light guide such as an optical fiber for light) into the proximal channel, allowing irradiation of the skin surface visible through the holes in the working surface with radiation generated from an external radiation source guided through the waveguide.

[0117] A sonotrode of one embodiment of such a device, sonotrode 118, is shown schematically in a cross-sectional side view in FIG. 5. Sonotrode 118 is substantially similar to sonotrode 74 of device 72, with several differences. First, sonotrode 118 has an optical element, a concave lens 120, in proximal portion 102 of hollow 88. Second, optical fiber 122 passes through axial passage 108 in bolt 75 and then through proximal channels (112c, 112b, and 112a) so that distal tip 124 of optical fiber 122 is positioned in proximal portion 102 of hollow 88 facing lens 120. Third, sonotrode 118 does not have a hold for seating an O-ring.

[0118] For use, the device is prepared in the usual manner, including operatively associating the transducer with a power source and connecting the optical fiber 122 to a light source (such as a laser, as known in the art of skin treatment). A lubricant, such as mineral oil, is applied to the area of ​​skin to be treated. The working surface 94 is brought into contact with the surface of the skin to be treated in a continuous reciprocating or circular motion, as known in the art of subcutaneous fat treatment.

[0119] In a first mode, the ultrasonic power source is activated to percutaneously treat subcutaneous tissue with ultrasonic vibrations via working surface 94 .

[0120] In a second mode, the light source is activated to illuminate the skin surface located at the holes 96 in the working surface 94. Light from the light source is guided by an optical fiber 122, exits a distal tip 124, and passes through a lens 120. The lens 120 diverges the light from the optical fiber 122 to illuminate at least a portion, and preferably all, of the skin visible through the holes 96 in the working surface 94. Any wavelength or combination of wavelengths of light may be used. In some preferred embodiments, light having a wavelength of 1060 nm (e.g., from a light source including a laser configured to generate light having a wavelength of 1060 nm) is known for its usefulness in percutaneous treatment of subcutaneous tissue.

[0121] In some embodiments, either the first mode or the second mode is activated. In some embodiments, the first mode and the second mode are activated alternately during a single treatment session, e.g., 10 seconds of the first mode and 10 seconds of the second mode. In some embodiments, the two modes are activated simultaneously for at least a portion of the time of the treatment session.

[0122] [Embodiment without air discharge or light irradiation] In some embodiments, the device is configured to evacuate air from the hollow during operation of the device, such as device 72 with sonotrode 74.

[0123] In some embodiments, such as devices with sonotrodes 118, the light is configured to illuminate the skin surface visible through the holes in the working surface.

[0124] In some embodiments, the device is configured to percutaneously treat subcutaneous tissue with ultrasonic vibrations, as known in the sonotrode art, without evacuation of air from the cavity or illumination of the skin. The sonotrode 126 of one embodiment of such a device is shown schematically in a cross-sectional side view in FIG.

[0125] Sonotrode 126 is substantially similar to sonotrodes 74 and 118, with some differences. Sonotrode 126 lacks a proximal channel. Instead of axial bolt 75 with axial passage 108, sonotrode 126 is associated with a transducer and reflector having a solid axial bolt 17. Furthermore, inner conical surface 86 and hollow 88 are perfect right cones with a conical apex at the proximal portion 102 of hollow 88.

[0126] Additional embodiments involving air evacuation As discussed above, in some embodiments, the device is configured to evacuate air from the hollow during operation of the device. In some such embodiments, the device comprises a non-axial through channel through the stem and / or conical wall. In some embodiments, the through channel provides fluid communication (e.g., of air) between the hollow and the outside. Alternatively or additionally, in some embodiments, the through channel provides passage of a physical component (e.g., a light guide such as an optical fiber) between the hollow and the outside.

[0127] A sonotrode 128 of one embodiment of such an apparatus, configured to evacuate air from a hollow via a non-through-axial channel, is shown schematically in cross-sectional side view in FIG.

[0128] Sonotrode 128 is substantially similar to sonotrode 126, with some differences. Sonotrode 128 includes a 2 mm diameter non-through-axis channel 130 and a operatively associated connector 114. Connector 114 is similar to connector 114 of device 72 and allows non-through-axis channel 130 to be connected to a suction generator, such as a pump.

[0129] The operation of the device including sonotrode 128 is substantially identical to the operation of device 72 including sonotrode 74, including treatment of subcutaneous tissue with ultrasonic vibrations and evacuation of air from the hollow during operation of the device via non-through-axial channel 130.

[0130] [Embodiments involving evacuation of air and irradiation of skin] In some embodiments, the device is configured to both illuminate the skin surface with light visible through holes in the working surface (similar to the device with sonotrode 118 shown in FIG. 5) and to expel air from the cavity (similar to device 72 with sonotrode 74 shown in FIG. 4 and device with sonotrode 128 shown in FIG. 7). One embodiment of such a device, device 132 with sonotrode 134, is shown schematically in a side view in FIG. 8A, and sonotrode 134 is shown in a schematic cross-sectional side view in FIG. 8B.

[0131] As seen in FIG. 8B, sonotrode 134 is substantially similar to sonotrode 118 with the addition of non-through-axial channel 130 and operatively associated adapter 114 as described for sonotrode 128.

[0132] In FIG. 8A, additional features of device 132 can be seen, including a standard connection piece 136 that allows connection between the proximal end of optical fiber 122 and a laser, an upper cooling jacket 138, and a lower cooling jacket 140.

[0133] The operation of the device 132 is identical to that of the device 118 with the air exhaust of the device 72 and the sonotrode 128 and will not be repeated here for the sake of brevity.

[0134] Further embodiments configured for irradiating the skin As mentioned above, in some embodiments, devices according to the teachings herein are configured to deliver electromagnetic radiation to the skin surface visible through holes in the working surface of the sonotrode, the delivery configuration being such that the radiation comes from the hollow interior towards the hollow open end.

[0135] Exemplary such embodiments include: the device comprising the sonotrode 118 described with reference to FIG. 5 , and the device 132 described with reference to FIGS. 8A and 8B . In such a device, an optical fiber 122 passes through the axial passage 108 of the axial bolt 75 and through the proximal axial channel 112 of the sonotrode, with the distal tip of the optical fiber 122 positioned within the proximal portion 102 of the hollow 88. Light from a light source operatively associated with the proximal end of the optical fiber 122 is guided by the optical fiber 122 and emitted from the distal tip of the optical fiber 122 toward the lens 120. The lens 120 diverges the light from the distal tip of the optical fiber 122 to illuminate at least a portion, and preferably all, of the skin visible through the hole 96 in the working surface 94.

[0136] In some alternative but similar embodiments, the device lacks an optical fiber 122. In some such embodiments, the device is similar to a device including a sonotrode 118 or device 132 as described immediately herein. However, instead of an optical fiber 122, a portion of the radiation source (e.g., a laser or a laser aperture) is at least partially disposed within the axial passage 108 and / or the axially proximal channel 112 of the axial bolt 75. In such embodiments, the radiation source is disposed within the passage 108 and / or channel 112, and radiation exiting the aperture of the radiation source travels axially toward the aperture 96 in the working surface 94, irradiating the skin surface visible through the aperture 96 with radiation when the radiation source is activated.

[0137] 9A, a device 142 similar to device 132 shown in FIGS. 8A and 8B is shown schematically. In device 142, component 122 is a waveguide for directing radiation generated by radiation source 144 into the hollow of sonotrode 134 to irradiate the skin surface visible through holes in working surface 94. In some embodiments, radiation source 144 is a component of device 142. In some alternative embodiments, radiation source 144 is not a component of device 142.

[0138] In some embodiments, the waveguide 122 is an optical fiber for guiding light (e.g., IR, UV, visible) from the light source 144 (e.g., consisting of a laser, diode laser, solid state laser, semiconductor laser, non-coherent light source, LED, flash lamp, or IPL source) to illuminate the skin visible through the holes in the working surface 142.

[0139] In some embodiments, waveguide 122 is a microwave waveguide for guiding microwaves from microwave source 144 (e.g., comprising a magnetron) to irradiate with microwave radiation the skin visible through the holes in working surface 142. In some such embodiments, there is an optical element similar to lens 122 (shown in FIG. 8B ), which, for example, in some embodiments, is an optical element for redirecting at least a portion of the microwaves emitted into the air from waveguide 122 so that most or all of the skin surface visible through the holes is simultaneously irradiated.

[0140] In some embodiments, waveguide 122 is a terahertz waveguide for guiding terahertz radiation from terahertz source 144 to irradiate the skin visible through the holes in working surface 142. In some such embodiments, there is an optical element similar to lens 122 (shown in FIG. 8B ), which is an optical element for redirecting at least a portion of the terahertz radiation emitted into the air from waveguide 122, for example, in some embodiments, such that most or all of the skin surface visible through the holes is simultaneously irradiated.

[0141] 9B, device 146 is shown schematically. Device 146 is similar to device 142 shown in FIG. 9A, but with a number of differences. The first difference is that waveguide 122 does not provide axial optical communication with the hollow of the sonotrode via an axial passageway and an axial proximal channel, as in device 142. Instead, in device 146, waveguide 122 is connected to connector 114, thereby providing optical communication from the outside of sonotrode 134 to its hollow via a non-axial through-channel (substantially identical to component 130 shown in FIG. 8B). Although not shown in FIG. 9B, the inner surface of the hollow of sonotrode 134 is completely diffusely reflective to light or other radiation guided into the hollow by waveguide 122, and the distal end of waveguide 122 (located in the hollow) is operatively associated with optical components for directing light (entering the hollow non-axially through waveguide 122) to the hole in working surface 94. Components 148, 150, 152 and 154 shown in FIG. 9B are described herein.

[0142] [Ultrasonic transducer] As mentioned above, in some embodiments, a device according to the teachings herein includes an ultrasonic transducer for generating ultrasonic longitudinal vibrations, and in FIG. 4, for ultrasonic transducer 12, distal surface 18 is the emitting surface of ultrasonic transducer 12.

[0143] The ultrasonic transducer of the device according to the teachings herein needs to be capable of generating sufficiently powerful ultrasonic longitudinal vibrations to enable the teachings herein to be practiced: if the transducer is not powerful enough, the device will be ineffective, while if the transducer is too powerful, the subject being treated may be injured.

[0144] Thus, the ultrasonic transducer of the device according to the teachings herein is an ultrasonic transducer that, in use, can have an ultrasonic power output at a selected frequency of appropriate power, in some embodiments between 40 watts and 120 watts, and in some embodiments between 45 watts and 100 watts, that is, it has been found that ultrasonic transducers preferably have an ultrasonic power output at a selected frequency of between 50 watts and 80 watts, and even between 60 watts and 70 watts.

[0145] Any suitable type of ultrasound transducer may be used in practicing the teachings herein, for example, a prestressed Langevin type ultrasound transducer. Suitable such transducers are available from a variety of commercial sources.

[0146] [Acoustic reflector] In some embodiments, a device according to the teachings herein further comprises an acoustic reflector operatively associated with the ultrasound transducer via the ultrasound transducer's proximal face. In FIG. 4, device 72 comprises acoustic reflector 16 operatively associated with ultrasound transducer 12 via proximal face 14. Acoustic reflectors are well-known components in the art that are commercially available from a variety of sources. Some acoustic reflectors are fluid-filled stainless steel housings. In some embodiments, such as device 72 shown in FIG. 4, the acoustic reflector is configured as part of a cooling assembly and includes, for example, a cooling fluid inlet 66 and a cooling fluid outlet 68.

[0147] [Ultrasonic power supply] As is known in the art, an alternating current oscillating at an ultrasonic drive frequency is required to drive an ultrasonic transducer to generate ultrasonic vibrations. Such alternating current is typically provided by an ultrasonic power supply operatively associated with the ultrasonic transducer. Accordingly, in some embodiments, a device according to the teachings herein includes an ultrasonic power supply operatively associated with the ultrasonic transducer and configured, when activated, to provide an alternating current to the ultrasonic transducer. In FIG. 4, device 72 includes an ultrasonic power supply 34 operatively associated with ultrasonic transducer 12.

[0148] An ultrasonic power supply suitable for practicing the teachings herein is preferably configured to provide an alternating current oscillating at a selected ultrasonic frequency for a sonotrode configured to operate with sufficient power such that the ultrasonic transducer has a desired power output, as described above. Thus, in some embodiments, the ultrasonic power supply is configured to provide an alternating current oscillating at a selected ultrasonic frequency with a power such that the ultrasonic transducer has a power output of between 40 watts and 120 watts, in some embodiments between 45 watts and 100 watts, in some embodiments between 50 watts and 80 watts, and in some embodiments, even between 60 watts and 70 watts.

[0149] As noted above, the length of the sonotrode and the diameter of the ring portion are determined, at least in part, by selecting a particular drive frequency and operating temperature. Specifically, to obtain maximum power output, both the length of the sonotrode and the outer diameter of the ring portion of the sonotrode should be close to resonance with the drive frequency: the closer to resonance, the closer to maximum power output.

[0150] nλ longitudinal The sonotrode length of ν longitudinal (sound velocity in the longitudinal direction of the sonotrode) is the driving frequency × λ longitudinal This means that it resonates with the drive frequency.

[0151] nλ transverse The diameter of the ring part of / 2 is ν transverse (Transverse sound velocity of the sonotrode) is the driving frequency × λ transverse This means that it resonates with the drive frequency.

[0152] In preferred embodiments, the length and ring portion diameter of a particular sonotrode according to the teachings herein are determined based on the longitudinal and transverse velocities of sound in the material from which the sonotrode is made at a particular temperature (e.g., room temperature or an expected operating temperature, e.g., 36°-40°C).

[0153] As known to those skilled in the art, the dimensions of an object such as a sonotrode and the speed of sound in the material from which the sonotrode is made change with changes in temperature. The combined effect of temperature-dependent changes (dimensions and speed of sound) over the typical temperature range of a sonotrode in use has been found to be sufficient to significantly reduce the power output of the sonotrode if a single, constant drive frequency is used during a treatment session.

[0154] To overcome this loss in output power, in some embodiments, the ultrasonic power supply is configured to provide an alternating current that oscillates at a selected ultrasonic frequency that falls within the range of frequencies that the power supply can provide.

[0155] In some such embodiments, the device and / or power supply and / or a controller associated with the device are configured to allow an operator to manually select a particular drive frequency provided by the power supply that falls within the range of frequencies the power supply can provide. At the beginning and / or during a treatment session, the user can "tune" the drive frequency to approach resonance with the sonotrode length and ring segment diameter at the moment of tuning, so that the output power is near the theoretical maximum.

[0156] Additionally or alternatively, in some such embodiments, the device and / or power supply and / or a controller associated with the device are configured to automatically select a particular drive frequency to be provided by the power supply that falls within the range of frequencies that the power supply can provide. At the beginning and / or during a treatment session, the drive frequency is automatically "tuned" to approach resonance with the sonotrode length and ring segment diameter at the moment of tuning, such that the output power is close to its theoretical maximum.

[0157] It has been found that such tuning of the drive frequency is preferably performed every 2-4 minutes, preferably every 2.5-3.5 minutes, for example every 3 minutes during a treatment session, and that the drive frequency can be adjusted to take into account factors such as sonotrode temperature, which may change during a treatment session.

[0158] There was some concern that the temperature dependence of the longitudinal sound velocity and sonotrode length, and the temperature dependence of the transverse sound velocity and sonotrode ring diameter, would be sufficiently different that it would be impossible to select a single drive frequency that would provide adequate power output at each temperature within the sonotrode's normal operating temperature range. Despite initial concerns, it has been found that for a sonotrode with a particular length and ring diameter that resonates with the same drive frequency at a temperature between 15°C and 40°C, it is possible to find a different drive frequency that is close enough to resonance with the length and ring diameter to provide sufficient power output in both the transverse and longitudinal modes at any temperature between 15°C and 40°C.

[0159] [Sonotrode structure and materials] The sonotrode of a device according to the teachings herein may be manufactured using any suitable method, i.e., in some embodiments, all components of the sonotrode are integrally formed to avoid imperfections, seams, and interfaces that could potentially impair the vibration transmission characteristics of the sonotrode.

[0160] The sonotrode of a device according to the teachings herein may be made of any suitable material. Due to the need for low acoustic loss, high dynamic fatigue strength, resistance to cavitation erosion, and chemical inertness, suitable materials include titanium, titanium alloys, aluminum, aluminum alloys, aluminum bronze, or stainless steel. Thus, in some embodiments, the sonotrode is made of a material selected from the group consisting of titanium, titanium alloys, aluminum, aluminum alloys, aluminum bronze, and stainless steel.

[0161] Of the materials listed, aluminum and aluminum alloys have acoustic impedances closest to that of the skin, so sonotrodes made of aluminum or aluminum alloys have excellent acoustic transmission characteristics relative to the skin. Therefore, in some preferred embodiments, the sonotrode is made of a material selected from the group consisting of aluminum and aluminum alloys.

[0162] In some such embodiments, the working surface is coated with aluminum oxide, although such embodiments are less preferred due to the possibility of leaving aluminum oxide residue on the treated skin surface. In some embodiments, the working surface is coated with an acoustic matching layer (e.g., PVDF or PTFE) on top of the aluminum oxide layer. Such a dual-layer coating improves the acoustic coupling of the working surface with the tissue. In such embodiments, the aluminum oxide layer is 75 μm or less thick, 50 μm or less thick, 40 μm or less thick, or even between 5 μm and 15 μm (e.g., 10 μm), while the acoustic matching layer applied to the surface of the aluminum oxide layer (e.g., PVDF or PTFE) is typically 1 to 50 μm thick, preferably 5 to 20 μm thick.

[0163] In some embodiments where the sonotrode is made of aluminum, a hard anodized layer on the working surface may produce poor results, as the hard anodized layer has an acoustic impedance different from that of the skin. In contrast, a soft anodized layer on the working surface produces acceptable results. Thus, in some embodiments, the working surface of the sonotrode is constructed with a soft anodized layer 5-20 μm thick, in some embodiments 8-12 μm thick, e.g., 10 μm thick.

[0164] [Cooling Assembly] As is known to those skilled in the art, during operation of an ultrasonic transducer, the associated sonotrode may heat to temperatures that make contact of the skin with the active surface of the sonotrode uncomfortable or even harmful. Furthermore, heating of the subcutaneous tissue may lead to excessive heating of the skin.

[0165] To reduce the occurrence of such undesirable effects when the device is used, in some embodiments, the device is configured to actively cool at least a portion of the working surface. To this end, in some embodiments, the device further comprises a cooling assembly configured, upon activation, to directly or indirectly cool at least a portion of the working surface (e.g., by cooling a distal portion of the transducer or a sonotrode that is in thermal communication with the working surface). In some embodiments, the device further comprises a cooling fluid channel in thermal communication with the working surface, e.g., the cooling fluid channel is in thermal communication with the sonotrode.

[0166] During use of the device, such cooling fluid channels may be operatively associated with a suitably configured cooling device or assembly that drives cooling fluid through the cooling fluid channels, thereby cooling the working surface. In some embodiments, the device further comprises a cooling assembly operatively associated with the cooling fluid channels that is configured, upon actuation, to drive cooling fluid through the cooling fluid channels, thereby cooling the working surface.

[0167] Cooling assemblies suitable for use with sonotrodes are well known, see for example the cooling assembly described in applicant's US Pat. No. 9,545,529, which is incorporated by reference as if fully set forth herein.

[0168] [Additional use of channels and / or passageways] As noted above, some devices according to the teachings herein include one or more channels / passages, e.g., one or more axial passages and / or one or more non-through-axial channels, that provide communication from the exterior to the hollow interior of the sonotrode. Such channels are useful for configuring devices to apply suction and / or irradiate the skin surface visible through the holes in the working surface of the sonotrode with electromagnetic radiation. In some embodiments, such channels or passages are useful for configuring devices according to the teachings herein for additional and / or alternative functionality.

[0169] In some embodiments, a device according to the teachings herein is further configured to acquire an image of the skin surface as seen from the hollow interior through the holes in the working surface of the sonotrode. In some such embodiments, the device further comprises a camera, the aperture of which is optically associated with the passageway and / or channel of the sonotrode such that, when activated, the camera acquires an image of the apparent skin surface from the hollow interior through the holes in the working surface. The camera may be any suitable camera, and in some embodiments, the camera is selected from the group consisting of an optical camera (e.g., a camera that acquires images of reflected light) and a terahertz imaging camera and scanner (e.g., from TeraSense Group, Inc., San Jose, California, USA). In some embodiments, the camera is attached directly to the sonotrode and is associated with the passageway and / or channel without a waveguide such that radiation reflected from the skin surface as seen through the holes in the working surface of the sonotrode enters the camera aperture directly through the camera lens. Alternatively, in some embodiments, the configuration of the device for image acquisition is such that the device comprises a waveguide having a proximal end associated with the camera aperture, the distal end of the waveguide leading to the hollow interior of the sonotrode, and the waveguide providing optical communication from the hollow interior to the proximal end of the waveguide. In some embodiments, the waveguide passes through a passageway and / or a through-channel. As a result, radiation, such as light or terahertz radiation, reflected from the skin surface viewed through the aperture in the active surface of the sonotrode is directed by the waveguide to the camera aperture. In some such embodiments, the device further comprises an optical element, such as one or more of a prism, a mirror, and a lens, to direct radiation reflected from the skin surface viewed through the aperture in a manner enabling improved image acquisition. In preferred such embodiments, the device is additionally configured to illuminate the skin surface viewed through the aperture for purposes of image acquisition.

[0170] In some embodiments, a device according to the teachings herein is further configured to determine the temperature of the skin surface as viewed from the hollow interior through the holes in the working surface of the sonotrode. Any suitable device or component for determining the temperature of the skin surface may be combined or integrated with a device according to the teachings herein to enable the temperature of the skin surface to be determined, for example, a fiber optic temperature sensor such as those available from Advanced Energy Industries, Inc. of Denver, Colorado, USA. Preferably, at least a portion of such a component or device passes through the passageway and / or channel.

[0171] In some embodiments, a device according to the teachings herein is further configured for administering a substance from the hollow interior to a skin surface visible through the holes in the working surface of the sonotrode. Typical substances are pharmaceutical or cosmetic products and are administered in any suitable form, such as a powder, liquid, aerosol, or spray. Any suitable device or component for administering a substance from the hollow interior to a skin surface visible through the holes in the working surface of the sonotrode may be combined or integrated with a device according to the teachings herein.

[0172] In some such embodiments, the passageway and / or through channel is operatively associated with the diaphragm, and for administration of a substance, the tip of a needle is used to pierce the diaphragm, after which the desired substance is administered through the needle, for example, with the aid of a syringe.

[0173] In some such embodiments, the passages and / or through-channels are configured to allow passage or connection of a material supply conduit, hi some such embodiments, a material supply conduit passing through or connected to the passages and / or through-channels is a component of the device.

[0174] 9B includes a camera 148 operatively associated with the hollow of the sonotrode 134 via an optical fiber passing axially through the hollow of the sonotrode 134 via the axial passage and axial proximal channel as described above, thereby providing axial optical communication between the camera 148 and the hollow of the sonotrode 134. When activated, the camera 148 acquires images (video or still images) of the skin surface as seen through the holes in the working surface 94, which are stored or displayed in real time on a suitable device as known in the art. During image acquisition by the camera 148, the skin surface as seen through the holes in the working surface 94 is illuminated with light from an LED located within the hollow and receiving power through a wire passing parallel to the optical fiber associated with the camera 148.

[0175] 9B includes a thermometer 150 operatively associated with the hollow of the sonotrode 134 via an optical fiber passing axially through the hollow of the sonotrode 134 via the axial passage and axial proximal channel as described above, thereby providing axial optical communication between the thermometer 150 and the hollow of the sonotrode 134. When activated, the thermometer 150 acquires the temperature of the skin surface visible through the holes in the working surface 94, and this temperature is stored or displayed in real time in a suitable device as known in the art.

[0176] 9B is further configured for administration of a substance from the hollow interior to a skin surface visible through the holes in working surface 94. Specifically, a reservoir / pump 152 is operatively associated with the hollow interior via a substance supply conduit 154. When the pump of reservoir / pump 152 is actuated, a substance, such as a liquid medicament, is drawn from the reservoir of reservoir / pump 152 and forced into the hollow through conduit 154, which opens at its distal end. The substance is forced out of the distal end of conduit 154 as an axially directed spray that is sufficiently divergent to cover a majority of the skin surface visible through the holes in working surface 94.

[0177] The device 146 shown in Figure 9B is operatively associated with a vacuum pump 156 through a suction conduit 158 ​​via a connector, not shown, that provides fluid communication between the conduit 158 ​​and the hollow core of the sonotrode 134, the connector being located on the back side of the device 146 as shown in Figure 9B. When the vacuum pump 156 is activated, it evacuates air from the hollow core through the conduit 158, and the device 146 can be used to apply suction to the skin visible through the holes in the working surface 94.

[0178] 9B further comprises a controller 160, which is a general-purpose computer modified in software and hardware to control the operation of the device 146. Specifically, the controller 160 enables simultaneous, alternating (e.g., serially, consecutively), and independent operation of all other components of the device 146, in any combination and permutation, including: activating the ultrasonic power supply 34 to drive the ultrasonic transducer 12; activating the radiation source 144 to irradiate the skin surface visible through the holes in the working surface 94; activating the camera 148 to capture an image of the skin surface as seen through the apertures in the working surface 94; activating the thermometer 150 to determine the temperature of the skin surface as seen through the apertures in the working surface 94; activating the pump of reservoir / pump 152 to dispense the substance onto the skin surface visible through the holes in working surface 94; activating the vacuum pump 156 to apply suction to the skin surface through the holes in the working surface 94; Includes.

[0179] [Pulsed ultrasound treatment] As mentioned in the introduction, it is known in the art to treat tissue using an ultrasonic transducer operatively associated with a sonotrode. The working surface of the sonotrode is acoustically coupled to the surface of the tissue, and an alternating current (AC) oscillating at an ultrasonic driving frequency is supplied from an ultrasonic power source to drive the ultrasonic transducer. The piezoelectric element of the ultrasonic transducer expands and contracts at the driving frequency in response to the oscillating AC potential, thereby generating ultrasonic longitudinal vibrations at the driving frequency. The generated ultrasonic longitudinal vibrations propagate axially through the sonotrode to the working surface. The working surface applies the ultrasonic vibrations to the surface, inducing ultrasonic longitudinal vibrations in the tissue.

[0180] It is known in the art to apply ultrasonic vibrations continuously for at least 10 seconds, typically 5 to 20 minutes, during a session to treat subcutaneous tissue, for example to reduce the amount of subcutaneous fat therein.

[0181] The inventors herein demonstrate that, for example, for the treatment of subcutaneous tissue, e.g., for reducing the amount of subcutaneous fat therein, superior results are achieved by periodically applying ultrasonic vibration pulses at a rate of at least two pulses per second during a session for treating subcutaneous tissue, e.g., for reducing the amount of subcutaneous fat therein, with each pulse having a duration of less than 250 milliseconds and any two pulses separated by at least 10 milliseconds. Without wishing to be bound by any one theory, it is presently believed that the onset of each pulse generates a shock wave in the subcutaneous tissue, which shock wave produces superior results.

[0182] Thus, in accordance with some embodiments of the teachings herein, there is provided an apparatus for treating tissue with ultrasonic vibrations, the apparatus comprising: i. a sonotrode having an active surface; ii. an ultrasonic transducer operatively associated with the sonotrode; iii. an ultrasonic power supply operatively associated with the ultrasonic transducer and configured to provide an alternating current (AC) oscillating at an ultrasonic drive frequency to drive the ultrasonic transducer; iv. a controller configured to receive user commands to vibrate the working surface at ultrasonic frequencies, and following receipt of such commands, to operate other components of the device to ultrasonically vibrate the working surface periodically at a rate of at least two pulses per second, each pulse having a duration of less than 250 milliseconds, and any two pulses separated by a rest phase of at least 10 milliseconds; Equipped with.

[0183] 10A and 10B, two such devices are shown schematically: device 162 in FIG. 10A and device 164 in FIG. 10B. Both devices include a sonotrode 20 having a working surface 26 operatively associated with an ultrasonic transducer 12. The ultrasonic transducer 12 is operatively associated with an ultrasonic power source 34. Both devices further include a controller 60, which is a general-purpose computer modified in software and hardware according to the features described above.

[0184] In some embodiments, the power source is configured to operate continuously when activated, and the device further comprises a controller controlled switch providing electrical communication between the ultrasonic transducer and the ultrasonic power source, the switch having at least two states: a closed state in which an alternating current provided by the power supply is directed to the ultrasonic transducer to drive the ultrasonic transducer; an open state in which no alternating current provided by the power supply is directed to the ultrasonic transducer to drive it; and The controller is configured to close the switch to provide the pulse and open the switch to provide the rest phase.

[0185] The device 162 shown in FIG. 10A includes a controller-controlled switch 166 having an open state (as shown) and a closed state in accordance with the features described above.

[0186] Additionally or alternatively, the power supply may have at least two states: an "on" state in which the power supply provides alternating current to drive the ultrasonic transducer; an "off" state in which the power supply does not provide alternating current to drive the ultrasonic transducer; and The controller is configured to provide pulses to the power supply towards an ON state and to provide rest phases to the power supply towards an OFF state.

[0187] The power supply 34 of the device 164 shown in FIG. 10B has at least two states, an "on" state and an "off" state, and the controller 160 is configured to provide pulses towards the power supply's on state and to provide rest phases towards the power supply's off state in accordance with the above characteristics.

[0188] As described above, the present device is a device for treating tissue with ultrasonic vibrations. As used herein, tissue refers to living tissue of a living organism, and in preferred embodiments, an animal, such as a human. In some embodiments, the device is for percutaneous treatment of tissue with ultrasonic vibrations, and the device components are configured therefor as known to those skilled in the art. In some embodiments, the device is for percutaneous treatment of subcutaneous tissue, and the device components are configured therefor as known to those skilled in the art.

[0189] The intensity of the pulses can be any suitable intensity sufficient to achieve the desired effect, typically at least 50% of the intensity of a similar ultrasound treatment using continuous application of ultrasonic vibrations, as known in the art.

[0190] The sonotrode may be any suitable sonotrode, including any suitable sonotrode known in the art, hi some embodiments, the sonotrode is any one of the sonotrodes described herein.

[0191] The ultrasound transducer can be any suitable ultrasound transducer, including any suitable ultrasound transducer known in the art, hi some embodiments, the ultrasound transducer is any one of the ultrasound transducers described herein.

[0192] The ultrasonic power source may be any suitable ultrasonic power source, including any suitable ultrasonic power source known in the art, suitable for use with the selected transducer and sonotrode.

[0193] As described above, the controller is configured to periodically ultrasonically vibrate the working surface at a rate of at least two pulses per second, each pulse having a duration of less than 250 milliseconds, and any two pulses separated by a rest phase of at least 10 milliseconds.

[0194] The ratio of pulse duration to rest phase duration can be any suitable ratio, in some embodiments, the ratio is between 30% pulse / 70% rest phase and 70% pulse / 30% rest phase during 1 second of operation.

[0195] In some embodiments, during 1 second of operation, the ratio is between 30% pulse / 70% rest phase and 70% pulse / 30% rest phase, in some embodiments, between 30% pulse / 70% rest phase and 60% pulse / 40% rest phase, and in some embodiments, even between 30% pulse / 70% rest phase and 50% pulse / 50% rest phase. In some preferred embodiments, during 1 second of operation, the ratio is between 35% pulse / 65% rest phase and 45% pulse / 55% rest phase, preferably between 37% pulse / 63% rest phase and 43% pulse / 57% rest phase, for example, 40% pulse / 60% rest phase.

[0196] The waveform (i.e., intensity as a function of time) of the driving alternating current (AC) supplied by the ultrasonic power supply may be any suitable waveform. In a preferred embodiment, the waveform is a square wave.

[0197] The pulse frequency may be any suitable frequency, as described above, being at least 2 pulses per second (2 Hz). In some embodiments, the pulse frequency is 20 Hz or less, or even 15 Hz or less. In some embodiments, the pulse frequency is 3 Hz or more, or even 4 Hz or more. In some preferred embodiments, the pulse frequency is about 5 Hz or more and about 15 Hz or less. In some preferred embodiments, the pulse frequency is selected from the group of about 5 Hz, about 10 Hz, and about 15 Hz.

[0198] The rise time of the drive current in the transducer can be any suitable rise time (the time it takes for the current in the transducer to go from zero to maximum current for a given pulse). Generally, shorter rise times are preferred. In some embodiments, the rise time is about 10% or less of the pulse width, about 8% or less, or even about 5% or less of the pulse width.

[0199] In some embodiments, the device controller is configured to allow pulsed application of ultrasonic vibrations (as described above) to alternate with continuous application of ultrasonic vibrations (as known in the art). In some such embodiments, the pulsed ultrasound treatment duration is between about 5 seconds and about 60 seconds, alternating with continuous ultrasound treatment durations of between about 5 seconds and about 60 seconds. In some embodiments, both treatment durations are between about 10 seconds and about 30 seconds, e.g., between about 15 seconds and about 25 seconds.

[0200] According to aspects of some embodiments of the teachings herein, there is also provided a method for treating tissue with ultrasonic vibrations, the method comprising: acoustically coupling the active surface of the sonotrode with the tissue surface; cyclically vibrating the working surface at an ultrasonic frequency at a rate of at least two pulses (of ultrasonic vibrations) per second for the duration of the treatment, each pulse having a duration of less than 250 milliseconds, and any two pulses separated by a rest phase of at least 10 milliseconds; Including, Here, the intensity of the pulse and the duration of treatment are sufficient to achieve the desired results.

[0201] The tissue surface can be any tissue surface, hi some embodiments, the tissue surface is skin, particularly human skin.

[0202] The method is a method for treating tissue using ultrasonic vibrations. As used herein, tissue refers to living tissue of a living organism, and in preferred embodiments, an animal, such as a human. In some embodiments, the method is for percutaneous treatment of tissue with ultrasonic vibrations. In some embodiments, the method is for percutaneous treatment of subcutaneous tissue. In some embodiments, the method is for percutaneously reducing the volume of subcutaneous fat, such that the pulse intensity and treatment duration are sufficient to achieve a reduction in the volume of subcutaneous fat below the surface.

[0203] The intensity of the pulses can be any suitable intensity sufficient to achieve the desired effect, typically at least 50% of the intensity of a similar ultrasound treatment using continuous application of ultrasonic vibrations as known in the art.

[0204] The treatment duration can be any suitable treatment duration. In some embodiments, the treatment duration is at least 50% of the duration of a similar ultrasound treatment using continuous application of ultrasonic vibrations as known in the art. Typically, the duration is between about 1 minute and about 1 hour.

[0205] Any suitable device or combination of devices, particularly devices according to the teachings herein, may be used to implement embodiments of the present methods. In some embodiments, known devices, such as known devices for percutaneous treatment of subcutaneous fat, may be used to implement embodiments of the present methods. In some embodiments, known devices are software-modified to implement embodiments of the present methods.

[0206] In some embodiments of the method, the ratio of pulse duration to rest phase duration is any suitable ratio, hi some embodiments, during 1 second of operation, the ratio is between 30% pulse / 70% rest phase and 70% pulse / 30% rest phase.

[0207] In some embodiments of the method, the ratio during 1 second is between 30% pulse / 70% rest phase and 70% pulse / 30% rest phase, in some embodiments between 30% pulse / 70% rest phase and 60% pulse / 40% rest phase, and in some embodiments even between 30% pulse / 70% rest phase and 50% pulse / 50% rest phase. In some preferred embodiments, during 1 second, the ratio is between 35% pulse / 65% rest phase and 45% pulse / 55% rest phase, preferably between 37% pulse / 63% rest phase and 43% pulse / 57% rest phase, e.g., 40% pulse / 60% rest phase.

[0208] The pulse frequency may be any suitable frequency, as described above, being at least 2 pulses per second (2 Hz). In some embodiments, the pulse frequency is 20 Hz or less, or even 15 Hz or less. In some embodiments, the pulse frequency is 3 Hz or more, or even 4 Hz or more. In some preferred embodiments, the pulse frequency is about 5 Hz or more and about 10 Hz or less.

[0209] The rise time of the drive current in the transducer can be any suitable rise time (the time it takes for the current in the transducer to go from zero to maximum current for a given pulse). Generally, shorter rise times are preferred. In some embodiments, the rise time is about 10% or less of the pulse width, about 8% or less, or even about 5% or less of the pulse width.

[0210] A given treatment session typically lasts between about 5 and about 30 minutes. However, treatments longer than 25 minutes, or even longer than 20 minutes, can become tedious and tiring for the person administering the treatment, especially if suction is applied to the skin. Thus, treatment sessions are typically between 5 and 20 minutes.

[0211] In some embodiments, pulsed application of ultrasonic vibrations (as described above) alternates with continuous application of ultrasonic vibrations (as known in the art) during a single treatment session. In some such embodiments, the treatment duration of the pulsed application of ultrasonic vibrations is between about 5 seconds and about 60 seconds, alternating with treatment duration of the continuous application of ultrasonic vibrations between about 5 seconds and about 60 seconds. In some embodiments, the treatment durations of both are between about 10 seconds and about 30 seconds, e.g., between about 15 seconds and about 25 seconds.

[0212] The above description has described that in some embodiments, one or more of various components are in communication with the hollow interior of the sonotrode, including a radiation source, a camera, a thermometer, a dosing component such as reservoir / pump 152, and a suction component such as vacuum pump 156. For the sake of brevity and clarity, not all options and permutations are set forth herein, but it will be apparent to one of ordinary skill in the art upon perusal of the description herein that any, some, or all of such components present may be in axial communication with the hollow, for example, through an axial channel in an axial bolt, and additionally or alternatively, any, some, or all of such components present may be in axial communication with the hollow, for example, non-through-axially.

[0213] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In case of conflict, the present specification, including definitions, will control.

[0214] As used herein, the terms "comprise," "include," "have," and grammatical variations thereof are deemed to specify stated features, integers, steps, or components, but do not exclude the addition of one or more additional features, integers, steps, components, or groups thereof. As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more," unless the context clearly dictates otherwise.

[0215] As used herein, when the word "about" is preceding a numerical value, the term "about" is intended to indicate ±10%. As used herein, a phrase of the form "A and / or B" means a selection from the group consisting of (A), (B), or (A and B). As used herein, a phrase of the form "at least one of A, B, and C" means a selection from the group consisting of (A), (B), (C), (A and B), (A and C), (B and C), or (A and B and C).

[0216] It will be understood that certain features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment may also be provided separately or in any suitable subcombination, or in any other described embodiment of the invention as suitable. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperable without those elements.

[0217] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the scope of the appended claims.

[0218] Citation or identification of any document in this application shall not be construed as an admission that such document is available as prior art to the present invention.

[0219] Section headings are used herein to facilitate understanding of the specification, but should not be construed as necessarily limiting.

Claims

1. 1. A device (72, 132, 142, 146) suitable for treating subcutaneous tissue, comprising: a. an ultrasonic transducer (12) for generating ultrasonic vibrations having a proximal surface (14) and a distal surface (18); b. a sonotrode (74, 118, 126, 128, 134) having a sonotrode axis (28), the sonotrode comprising: i. a proximal surface (56) in contact with and acoustically coupled to the distal surface (18) of the ultrasonic transducer (12); ii. a frusto-conical portion (76) having a proximal end (78) with a smallest radius and a distal end (80) with a largest radius, said frusto-conical portion (76) being defined by a conical wall (82) having an outer conical surface (84) and an inner conical surface (86), the inner conical surface (86) at least partially defining a hollow (88); a ring portion (90) extending radially outward from the distal end (80) of the frusto-conical portion (76) having a ring-shaped proximal surface (92) and a ring-shaped distal surface, the ring-shaped distal surface being a working surface (94) of a sonotrode (74), the hole (96) in the working surface (94) defining the open end of the hollow (88).

2. the sonotrode is configured for operation at a selected ultrasonic drive frequency and acts as an acoustic amplitude transducer for both ultrasonic transverse vibrations and ultrasonic longitudinal vibrations; The structure acting as the acoustic amplitude transducer for longitudinal vibration at the selected ultrasonic drive frequency may have a length of the sonotrode from the proximal surface to the working surface of: nλlongitudinal / 2 where n is a positive integer greater than 0; and λ longitudinal is the wavelength of the ultrasonic longitudinal wave of the sonotrode at the selected ultrasonic driving frequency; The structure acting as the acoustic amplitude transducer for transverse vibration at the selected ultrasonic drive frequency comprises a ring portion (90) having a diameter of: nλtransverse / 2 where n is a positive integer greater than 0; and 2. The apparatus of claim 1, wherein λ transverse is the wavelength of the ultrasonic transverse wave of the sonotrode.

3. The apparatus of claim 2 , wherein the selected ultrasonic drive frequency is between 30 kHz and 200 kHz.

4. 4. The device of claim 1, configured to apply suction to a skin surface through the holes (96) in the working surface (94) of the sonotrode (74, 128, 134).

5. 5. The apparatus of claim 1, wherein the ultrasonic transducer is a prestressed Langevin type transducer including an axial bolt having a distal end and a proximal end.

6. The device according to any one of the preceding claims, wherein the diameter of the hole (96) is between 10% and 70% of the diameter of the ring portion (90).

7. 7. The apparatus of claim 1, wherein the sonotrode further comprises a stem (104), the stem having a proximal face that is the proximal face (56) of the sonotrode and a distal end that is the proximal end (78) of the conical wall (82).

8. The apparatus of any one of claims 1 to 7, wherein the sonotrode comprises a proximal channel (112) between the hollow (88) near the transducer (12) and the outside of the sonotrode.

9. the ultrasonic transducer (12) is a prestressed Langevin type transducer including an axial bolt (75) having an axial passage (108) between a distal end and a proximal end of the axial bolt (75); the sonotrode includes a bore (106) for engaging the distal end of the axial bolt (75); 9. The apparatus of claim 8, wherein the proximal channel (112) of the sonotrode and the axial passage (108) of the axial bolt together provide communication between the hollow (88) and the proximal end of the axial bolt (75).

10. 10. The apparatus of claim 1, wherein the sonotrode comprises a non-through-axis channel (130) that provides communication between the hollow (88) and the outside of the sonotrode through the conical wall (82).

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