An ultrasonic applicator for treating skin tissue, an ultrasonic system and methods of use thereof

Abstract

A method for initiating an ultrasonic applicator to treat skin tissue as part of a cosmetic treatment includes initiating at least one ultrasonic transducer of the ultrasonic applicator by a console, the ultrasonic applicator configured to generate and deliver ultrasonic energy to cosmetically treat skin tissue, identifying a potential degradation in efficiency of the ultrasonic energy delivery during the initiating, modifying the initiating in accordance with the identified results.

Description

[0001] Related Applications

[0002] This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 943,309, filed December 4, 2019, and International Application No. WO 2020 / 194312, published March 26, 2020, the contents of which are hereby incorporated by reference in their entirety.

[0003] TECHNICAL FIELD AND BACKGROUND

[0004] The present invention, in some embodiments thereof, relates to systems for various skin treatments, and more particularly, but not exclusively, to an ultrasound system for various skin treatments. SUMMARY

[0005] Some examples of some embodiments of the present invention are listed below. Features of one example can be used in combination with features of other examples:

[0006] Example 1. A method for initiating an ultrasound applicator to treat skin tissue as part of a cosmetic treatment, comprising:

[0007] initiating, by a console, at least one ultrasound transducer of the ultrasound applicator, the ultrasound transducer configured to generate and deliver ultrasound energy for cosmetic treatment of skin tissue;

[0008] identifying a decline in potential efficiency of the ultrasound energy delivery during the initiation; and

[0009] modifying the initiation according to the identified results.

[0010] Example 2. The method according to Example 1, wherein the initiating comprises intermittently initiating the at least one ultrasound transducer of the ultrasound applicator for a period of at least 1 month at the same time for treating two or more subjects, and wherein the identifying comprises identifying the decline during the period.

[0011] Example 3. The method according to any of the preceding examples, the identifying comprises identifying changes in the ultrasound delivery potential efficiency when treating different skin areas of a subject using the same ultrasound transducer or the same group of ultrasound transducers.

[0012] Example 4. The method according to any of the preceding examples, the method comprises receiving signals from one or more temperature sensors in the ultrasound applicator, and wherein the identifying comprises identifying heat increase based on the received signals.

[0013] Example 5. The method of any of the preceding examples, the method comprising measuring a plurality of impedance values of the at least one ultrasound transducer, and wherein the identifying comprises identifying the degradation in the ultrasound generation and / or delivery potential efficiency based on the measured plurality of impedance values.

[0014] Example 6. The method of any of the preceding examples, wherein the at least one ultrasound transducer comprises two or more ultrasound transducers, wherein the identifying comprises identifying a degradation in an efficiency of converting electrical energy to ultrasound energy by at least one ultrasound transducer of the two or more ultrasound transducers, and wherein the modifying comprises stopping activation of the at least one ultrasound transducer while continuing activation of at least one different ultrasound transducer of the two or more ultrasound transducers, or disabling activation of the ultrasound transducer.

[0015] Example 7. The method of example 6, wherein the modifying comprises increasing activation duration and / or power of the at least one activated ultrasound transducer to compensate for the stopped at least one ultrasound transducer.

[0016] Example 8. The method of example 1, wherein the identifying comprises identifying a degradation in an efficiency of converting electrical energy to ultrasound energy by at least one ultrasound transducer, and wherein the method comprises communicating an indication to a user to continue using the ultrasound applicator or to replace the ultrasound applicator by a plurality of instructions.

[0017] Example 9. The method of any of the preceding examples, the method comprising sending an alarm signal and / or at least one log file to a remote device based on the identified degradation.

[0018] Example 10. The method of example 9, wherein the identifying comprises remotely modifying the activation of the at least one ultrasound transducer or an activation of the applicator using a signal from the remote device.

[0019] Example 11. The method of any of the preceding examples, the method comprising:

[0020] receiving an identification (ID) indication associated with the ultrasound applicator prior to the activating; and

[0021] wherein the activating comprises activating the at least one ultrasound transducer if the received ID indication is an authorized ID indication.

[0022] Example 12. An ultrasound system for treating skin tissue, comprising:

[0023] a console comprising a control circuit, a memory, and at least one electrical circuit configured to energize one or more ultrasonic transducers;

[0024] an ultrasonic applicator coupled to the console comprising at least one ultrasonic transducer electrically connected to the at least one electrical circuit, wherein the at least one ultrasonic transducer is configured to vibrate and generate ultrasonic energy in response to the electrical circuit being energized;

[0025] wherein the control circuit is configured to:

[0026] send signals to the electrical circuit to energize the at least one ultrasonic transducer according to a plurality of indications stored in the memory;

[0027] identify a decline in potential efficiency of generation and / or delivery of the ultrasonic energy to the skin tissue; and

[0028] send signals to the electrical circuit to modify an activation of the at least one ultrasonic transducer according to the plurality of results of the identification.

[0029] Example 13. The system of Example 12, wherein the control circuit is configured to send signals to the electrical circuit to energize the at least one ultrasonic transducer intermittently during a period of at least 30 days according to a plurality of indications stored in the memory.

[0030] Example 14. The system of any of Examples 12 or 13, wherein the control circuit is configured to identify the decline by measuring a plurality of impedance values or a plurality of changes in impedance values of the at least one ultrasonic transducer during energization by the at least one electrical circuit.

[0031] Example 15. The system of any of Examples 12 to 14, wherein the ultrasonic applicator comprises one or more thermistors configured to sense temperature levels of the at least one ultrasonic transducer and / or proximate to the at least one ultrasonic transducer, and wherein the control circuit identifies the decline based on signals received from the one or more thermistors.

[0032] Example 16. The system of any of Examples 12 to 15, wherein the control circuit is configured to identify the decline by identifying a decline in the at least one ultrasonic transducer’s conversion of electricity to ultrasonic energy.

[0033] Example 17. The system of any of examples 12-16, comprising a user interface configured to generate and deliver a human detectable indication to a user of the system, wherein the control circuitry sends a signal to the user interface to generate and deliver the human detectable indication by way of instructions to replace the ultrasound applicator.

[0034] Example 18. The system of any of examples 12-17, wherein the console comprises a communication circuitry configured to generate and receive signals from a remote device, and wherein the control circuitry sends a signal to the communication circuitry to generate and send an indication signal to a remote device if the identified efficiency degradation is greater than a reference value indication stored in the memory.

[0035] Example 19. The system of example 18, wherein the at least one ultrasound applicator comprises two or more ultrasound transducers, and wherein the communication circuitry receives a signal from the remote device to a user of the system by way of instructions to deactivate the ultrasound applicator or at least one of the two or more ultrasound transducers in accordance with the results of the identification.

[0036] Example 20. The system of any of examples 12-19, wherein the applicator comprises an identification (ID) tag, and wherein the console comprises an ID tag reader configured to read the ID tag and store at least one indication of the ID tag in the memory.

[0037] Example 21. The system of example 20, wherein the control circuitry is configured to determine whether the at least one ID tag indication is an authorized ID tag indication, and to activate or deactivate the at least one ultrasound transducer in accordance with the results of the determination.

[0038] Example 22. An applicator of an ultrasound system, comprising:

[0039] an applicator body having at least one ultrasound emitting surface shaped and dimensioned to contact a skin, and at least two spaced apart ultrasound transducers, wherein each of the at least two spaced apart ultrasound transducers comprises a first surface facing the ultrasound emitting surface of the applicator body, and a first electrode connected to the first surface of the ultrasound transducer;

[0040] non-passivated electrical wiring configured to energize each of the at least two ultrasound transducers, connected to the first electrode of each of the at least two spaced apart ultrasound transducers;

[0041] an insulating coating fixedly attaching the non-passivated electrical wiring to the electrode, the insulating coating configured to seal the non-passivated electrical wiring and the at least two ultrasonic transducers from fluids and air.

[0042] Example 23. The applicator of example 22, wherein the non-passivated electrical wiring is connected to the first electrode by soldering.

[0043] Example 24. The applicator of any of examples 22 or 23, comprising:

[0044] at least one additional flexible non-passivated electrical conductor connected to the plurality of thermistors, wherein the flexible non-passivated electrical conductor is bent to position the plurality of thermistors between the at least two spaced apart ultrasonic transducers, and wherein the insulating coating electrically isolates the non-passivated electrical wiring and the flexible non-passivated electrical conductor to prevent shorting therebetween.

[0045] Example 25. The applicator of any of examples 22 to 24, wherein the ultrasonic applicator comprises:

[0046] a second electrode attached to a second surface opposite the first surface of each of the at least two spaced apart ultrasonic transducers;

[0047] at least one electrical conductor;

[0048] a filler layer disposed between the second electrode and the at least one electrical conductor, wherein the filler layer comprises a non-conductive adhesive and a monolayer of electrically conductive rigid particles in the non-conductive adhesive, the monolayer disposed between and electrically connecting the second electrode and the at least one electrical conductor.

[0049] Example 26. The applicator of example 25, wherein the plurality of rigid particles have a spherical or circular shape.

[0050] Example 27. The applicator of example 26, wherein a thickness of the monolayer of the plurality of rigid particles is in a range of 10-300 pm.

[0051] Example 28. A method of performing an ultrasonic treatment of skin tissue, comprising:

[0052] placing an ultrasonic applicator comprising at least two ultrasonic transducers in contact with a skin surface;

[0053] activating the at least two ultrasonic transducers according to a treatment protocol;

[0054] measuring impedance values of the at least two ultrasonic transducers separately during the initiation;

[0055] detecting changes in impedance values of at least one ultrasonic transducer relative to impedance values of at least one different ultrasonic transducer when changing frequency levels;

[0056] modifying at least one parameter of the treatment protocol according to the detected changes.

[0057] Example 29. The method according to example 28, comprising:

[0058] determining reference impedance values of each of the at least two ultrasonic transducers prior to the initiation; wherein the detecting comprises detecting changes in each ultrasonic transducer between the separately measured impedance values and the determined reference impedance values.

[0059] Example 30. The method according to example 29, wherein the determining reference impedance values comprises separately initiating each of the ultrasonic transducers and measuring impedance values over a range of frequencies of each ultrasonic transducer.

[0060] Example 31. The method according to any of examples 28-30, wherein the initiating comprises initiating the at least two ultrasonic transducers to generate at least one pulse of ultrasonic waves toward skin tissue, and wherein the separately measuring comprises measuring impedance values of each of the at least two ultrasonic transducers before, during and / or after the generating of the at least one ultrasonic pulse.

[0061] Example 32. The method according to any of examples 28-31, wherein the modifying comprises stopping the initiating if the detected changes are above a predetermined value.

[0062] Example 33. The method according to any of examples 28-32, wherein the modifying comprises modifying the at least one parameter of the treatment protocol to heat a volume of tissue having a desired shape and / or size and a desired depth in the skin.

[0063] Example 34. The method according to example 33, wherein the modifying comprises modifying activity of at least one ultrasonic transducer of the applicator to generate the heated volume of tissue according to the detecting.

[0064] Example 35. The method according to example 34, wherein the modifying activity comprises increasing an activity of the at least one ultrasonic transducer relative to at least one different ultrasonic transducer of the same applicator.

[0065] Example 36. The method of example 34, wherein the modifying activity comprises modifying a frequency and / or amplitude of the plurality of ultrasound waves generated by the at least one ultrasound transducer.

[0066] Example 37. The method of any of examples 28-36, wherein the modifying comprises changing a position and / or orientation of the ultrasound applicator relative to the skin in accordance with the detecting.

[0067] Example 38. An ultrasound system for ultrasound treatment of skin tissue, comprising:

[0068] an ultrasound applicator comprising:

[0069] two or more ultrasound transducers configured to generate a plurality of ultrasound waves;

[0070] electrical wiring connected to the two or more ultrasound transducers;

[0071] a console coupled to the ultrasound applicator, the console comprising:

[0072] memory for storing a plurality of impedance value indications;

[0073] a control circuit electrically connected to the electrical wiring, wherein the control circuit is configured to:

[0074] activate the two or more ultrasound transducers in accordance with the plurality of indications stored in the memory;

[0075] measure a plurality of impedance values on each of the two or more ultrasound transducers during a plurality of changes in frequency of the plurality of ultrasound waves, respectively;

[0076] detect a plurality of relative changes in impedance measured between the two or more ultrasound transducers;

[0077] in response to the detected plurality of relative changes, modify activation of at least one ultrasound transducer of the at least two ultrasound transducers.

[0078] Example 39. The system of example 38, wherein the control circuit determines a relationship between the individually measured plurality of impedance values for each ultrasound transducer and a plurality of impedance reference values for the particular ultrasound transducer stored in the memory.

[0079] Example 40. The system of any of Examples 38 or 39, comprising a user interface configured to generate a human detectable indication, and wherein the control circuitry sends a signal to the user interface to generate the human detectable indication based on the detected plurality of changes and / or if the activation of the at least one ultrasound transducer is modified.

[0080] Example 41. The system of any of Examples 38 to 40, wherein the control circuitry is configured to stop an activation of at least one ultrasound transducer if the plurality of impedance measurements of the at least one ultrasound transducer differs from an average of the plurality of impedance measurements of the two or more ultrasound transducers of the ultrasound applicator by more than 5%.

[0081] Example 42. The system of any of Examples 38 to 41, wherein the control circuitry is configured to modify at least one activation parameter of at least one ultrasound transducer if the plurality of impedance measurements of the at least one ultrasound transducer differs from an average of the plurality of impedance measurements of the two or more ultrasound transducers by more than 5%.

[0082] Example 43. The system of any of Examples 38 to 42, wherein the control circuitry is configured to modify at least one activation parameter of at least one ultrasound transducer if the plurality of impedance measurements of the at least one ultrasound transducer differs from an average of the plurality of impedance measurements of the two or more ultrasound transducers by more than 5%.

[0083] Example 44. The system of any of Examples 42 or 43, wherein the at least one activation parameter comprises one of a group of parameters consisting of activation duration, drive voltage, ultrasound frequency, acoustic intensity, pre-cooling and post-cooling time.

[0084] Example 45. An applicator of an ultrasound system, comprising:

[0085] an applicator body having at least one ultrasound emitting surface shaped and dimensioned to contact a skin;

[0086] at least one ultrasound transducer comprising a surface facing the ultrasound emitting surface and an electrode connected to the ultrasound transducer surface;

[0087] electrical wiring configured to energize the at least one ultrasound transducer, wherein the electrical wiring is connected to the electrode by soldering.

[0088] Example 46. The applicator of Example 45, wherein a portion of the electrical wiring connected to the electrode comprises non-passivated electrical wiring.

[0089] Example 47. An applicator of an ultrasound system, comprising:

[0090] an applicator body having at least one ultrasound emitting surface shaped and sized to contact a skin;

[0091] at least one ultrasound transducer comprising a surface opposite the at least one ultrasound emitting surface and an electrode connected to the ultrasound transducer surface;

[0092] at least one electrical conductor;

[0093] a filler layer disposed between the electrode and the at least one electrical conductor, wherein the filler layer comprises a non-conductive adhesive and a monolayer of electrically conductive rigid particles in the non-conductive adhesive, wherein the electrically conductive rigid particles are disposed between and electrically connect the electrode and the at least one electrical conductor.

[0094] Example 48. The applicator of example 47, wherein the rigid particles have a spherical or a circular shape.

[0095] Example 49. An applicator of an ultrasound system, comprising:

[0096] an applicator body having at least one ultrasound emitting surface shaped and sized to contact a skin;

[0097] at least one ultrasound transducer comprising a surface facing the ultrasound emitting surface and a silver electrode connected to the ultrasound transducer surface.

[0098] Example 50. The applicator of example 49, comprising:

[0099] non-passivated electrical wiring configured to energize the at least one ultrasound transducer connected to the silver electrode.

[0100] The following are some additional examples of some embodiments of the invention:

[0101] Example 1. An ultrasound applicator, comprising:

[0102] an applicator body having at least one flat surface shaped and sized to contact a skin, comprising:

[0103] at least two spaced apart ultrasound transducers arranged in a planar transducer array proximate the at least one flat surface;

[0104] wherein the applicator is configured to have an average time between failures of at least 1 month when delivering an average of at least 1000 pulses per day.

[0105] Example 2. The applicator of Example 1, wherein the applicator is configured to generate and emit a plurality of ultrasound waves having a plurality of parameter values selected to heat each of a plurality of spaced-apart elongated volumes of tissue in a skin contacting the at least one planar surface to a temperature above 50°C having a volume of at least 1 cm 3 .

[0106] Example 3. The applicator of Example 2, wherein the array of ultrasound transducers is configured to generate and emit the plurality of ultrasound waves to heat the plurality of spaced-apart elongated volumes of tissue, wherein the plurality of spaced-apart elongated volumes of tissue are located on a plane at a depth of at least 3 mm from a surface of a skin contacting the at least one planar surface, and wherein the plane is substantially parallel to the array of transducers.

[0107] Example 4. The applicator of Example 3, comprising at least one control circuit individually electrically connected to each ultrasound transducer, wherein the control circuit controls at least one activation parameter of each of the plurality of ultrasound transducers in the array to generate the plane of heated elongated volumes of tissue in the skin.

[0108] Example 5. The applicator of any of Examples 2-4, wherein the array of ultrasound transducers is configured to generate and emit the plurality of ultrasound waves to heat the plurality of spaced-apart elongated volumes of tissue, wherein the plurality of spaced-apart elongated volumes of tissue are cylindrical volumes of tissue parallel to the array of ultrasound transducers.

[0109] Example 6. The applicator of any of Examples 2-5, wherein an area of a plurality of ultrasound emitting surfaces of the array of planar transducers is at least 10 mm 2 .

[0110] Example 7. The applicator of any of Examples 2-6, wherein the plurality of ultrasound waves generated by the array of ultrasound transducers are unfocused ultrasound waves.

[0111] Example 8. The applicator of any of Examples 2-7, wherein the plurality of parameter values of the generated plurality of ultrasound waves include at least one of frequency, intensity, and / or duration.

[0112] Example 9. The applicator of any of Examples 2-8, wherein the array of multiple ultrasonic transducers is configured to generate and emit the multiple ultrasonic waves to heat the spaced-apart multiple elongated volumes of tissue, wherein a minimum distance between adjacent multiple elongated volumes of tissue is at least 0.5 mm.

[0113] Example 10. An ultrasonic applicator assembly comprising:

[0114] at least one vibration-generating assembly;

[0115] at least one electrode connected to at least one surface of the vibration-generating assembly;

[0116] at least one electrical conductor electrically connected to a power source;

[0117] an electrically conductive layer between the at least one electrode and the at least one electrical conductor comprising a single layer of a non-conductive filler and a plurality of electrically conductive particles within the filler, wherein the plurality of particles contact the at least one electrode and the at least one electrical conductor.

[0118] Example 11. The assembly of Example 10, wherein a size or diameter of the plurality of electrically conductive particles differs from an average size or average diameter of the plurality of electrically conductive particles by less than 5%.

[0119] Example 12. The assembly of any of Examples 10 or 11, wherein each of the plurality of electrically conductive particles comprises a non-conductive core surrounded by an electrically conductive layer.

[0120] Example 13. The assembly of Example 12, wherein the core comprises a non-conductive polymer or mixture of polymers.

[0121] Example 14. The assembly of any of Examples 12 or 13, wherein the electrically conductive layer surrounding the core comprises a metallic material or mixture of metallic materials, the metallic materials including at least one of copper, silver, and tungsten.

[0122] Example 15. The assembly of any of Examples 10-14, wherein a shape of each of the plurality of electrically conductive particles is a sphere.

[0123] Example 16. The assembly of any of Examples 10-15, wherein the shape and size of the plurality of electrically conductive particles are designed to maintain the vibration-generating assembly substantially parallel to the at least one electrical conductor.

[0124] Example 17. The assembly of any of Examples 10-16, wherein the plurality of electrically conductive particles are thermally conductive particles for conducting heat away from the vibration-generating assembly through the non-conductive layer.

[0125] Example 18. The assembly of any of Examples 10-17, wherein the non-conductive layer comprises a cured adhesive material.

[0126] Example 19. The assembly of any of Examples 10-17, wherein the at least one vibration generating assembly comprises a PZT element.

[0127] Example 20. A radio frequency (RF) power circuit assembly, comprising:

[0128] a main rigid circuit board comprising electrical wiring and a plurality of integral socket connectors;

[0129] at least two rigid RF signal amplifier cards, each comprising a circuit configured to generate a high power RF signal, at least one signal measurement circuit, and at least one integral connector configured to be inserted into one of the plurality of integral socket connectors of the main rigid circuit board,

[0130] wherein the at least two RF signal amplifier cards are arranged adjacent to each other on the main rigid circuit board a distance apart that allows sufficient air flow between adjacent cards to cool the circuits on the cards by inserting each RF signal amplifier card into a different integral socket connector of the plurality of socket connectors of the main rigid circuit board.

[0131] Example 21. The assembly of Example 20, wherein each of the at least two rigid RF amplifier cards comprises at least one electromagnetic shield shaped and sized to cover the circuit.

[0132] Example 22. The assembly of Example 21, wherein the electromagnetic shield covers at least 50% of the outer surface of each rigid RF signal amplifier card.

[0133] Example 23. The assembly of any of Examples 21 or 22, wherein the at least one electromagnetic shield comprises at least one heat sink.

[0134] Example 24. The assembly of any of Examples 20-23, wherein the circuit of each of the plurality of rigid RF signal amplifier cards is configured to generate an output RF electrical power signal of at least 0.5 watts.

[0135] Example 25. The assembly of any of Examples 20-24, wherein a minimum distance between circuits of two adjacent RF signal amplifier cards connected to the main rigid circuit board is at least 3 cm.

[0136] Example 26. An ultrasound system for delivering ultrasound energy to a plurality of deep tissue layers of the skin, comprising:

[0137] a console;

[0138] an elongated umbilical connection channel having a proximal end comprising a console connector configured to connect to the console, and a distal end;

[0139] an applicator body coupled to the distal end of the elongated umbilical connection channel, comprising:

[0140] two or more ultrasound transducers;

[0141] electrical wiring connected to the two or more ultrasound transducers;

[0142] a cooling system comprising at least one tube configured to circulate a coolant fluid through the umbilical connection channel between the console and the applicator body;

[0143] wherein the electrical wiring is electrically isolated from the cooling system by a solidified sealing fluid configured to cover the electrical wiring within the applicator body in a liquid state and solidify within the applicator body.

[0144] Example 27. The ultrasound system of example 26, wherein the console connector of the elongated umbilical connection channel comprises at least one electrical connector and at least one coolant fluid connector, wherein the at least one electrical connector and the at least one coolant fluid connector are electrically isolated by a solidified sealing fluid configured to solidify within the elongated umbilical connection channel.

[0145] Example 28. The ultrasound system of any of examples 26 or 27, wherein the solidified sealing fluid comprises silicone.

[0146] Example 29. An ultrasound applicator printed circuit board (PCB) comprising:

[0147] an ultrasound power PCB configured to deliver electrical power to at least two ultrasound transducers arranged in an array, comprising at least two spaced apart rigid PCBs coupled to each other by a flex printed circuit, wherein each of the two or more rigid PCBs is configured to be coupled to a different side of the transducer array, and the plurality of transducers are positioned in an opening between the two or more spaced apart rigid PCBs.

[0148] Example 30. The PCB of example 29, wherein each of the two or more spaced apart rigid PCBs comprises a different electrical lead for each ultrasound transducer in the array.

[0149] Example 31. The PCB of any of Examples 29 or 30, comprising a rigid PCB coupled to the flex printed circuit and electrically connected to each of the two or more rigid PCBs.

[0150] Example 32. An ultrasound applicator, comprising:

[0151] at least two ultrasound transducers positioned proximate a skin contact surface of an ultrasound applicator, wherein the at least two ultrasound transducers are mechanically coupled to at least one heat exchanger configured to conduct heat away from the at least two ultrasound transducers;

[0152] at least one surface thermal sensor positioned proximate the skin contact surface and configured to record temperature levels of a skin contacting the applicator;

[0153] at least one heat exchanger thermal sensor configured to record temperature levels of the at least one heat exchanger.

[0154] Example 33. The ultrasound applicator of Example 32, comprising:

[0155] a circuit positioned within the ultrasound applicator, the circuit electrically connected to the at least two ultrasound transducers and the at least one surface thermal sensor and the at least one heat exchanger thermal sensor, wherein the circuit is configured to transmit electrical power to the at least two ultrasound transducers based on signals received from the at least one surface thermal sensor and the at least one heat exchanger thermal sensor.

[0156] Example 34. The ultrasound applicator of any of Examples 32 or 33, wherein the at least one surface thermal sensor and / or the at least one heat exchanger thermal sensor comprises a thermistor.

[0157] Example 35. A system for delivering ultrasound, comprising:

[0158] an ultrasound applicator shaped and sized to be placed in contact with the skin, the ultrasound applicator including at least two ultrasound transducers configured to deliver ultrasound to a tissue volume within the skin and a cooling system configured to cool a surface of the skin contacting the applicator;

[0159] a console including a cooling system and at least one radio frequency (RF) electrical power card functionally coupled to the ultrasound applicator and configured to move over a surface, wherein the console has a footprint on the surface of less than 0.5 m 2 .

[0160] Example 36. The system of example 35, wherein a height of the console is at least 1 m.

[0161] Example 37. The system of any of examples 35 or 36, wherein the console cooling system is located at a bottom of the console, wherein the at least one RF electrical power card is located at a higher location within the console.

[0162] Example 38. A method of electrical power assessment of a high frequency signal, comprising:

[0163] receiving a high frequency RF signal;

[0164] generating a sinusoidal signal from the high frequency RF signal using a low pass filter;

[0165] sampling the sinusoidal signal;

[0166] calculating an RMS voltage from the sampled sinusoidal signal.

[0167] Example 39. The method of example 38, the method comprising:

[0168] monitoring variability of the calculated RMS voltage.

[0169] Example 40. The method of example 39, the method comprising:

[0170] modifying amplification of the high frequency RF signal based on the monitored results.

[0171] Example 41. The method of any of examples 38 to 40, wherein the receiving comprises receiving a high frequency RF signal having a frequency in a range of 5 MHz to 20 MHz.

[0172] Example 42. The method of any of examples 38 to 41, the method comprising:

[0173] measuring an indication of an amplitude of the sinusoidal signal;

[0174] determining an acoustic output of a plurality of ultrasound transducers receiving the sinusoidal signal based on the measured amplitude indication.

[0175] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the application pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the application, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0176] As will be appreciated by one skilled in the art, embodiments of the present application can be embodied as a system, method or computer program product. Accordingly, embodiments of the present application can take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that can all generally be referred to herein as a "circuit," "module" or "system." Furthermore, embodiments of the present application can take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon. Implementation of the method and / or system of embodiments of the present application can involve performing and / or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of embodiments of the method and / or system of the present application, several selected tasks could be implemented by hardware, by software or by firmware or by a combination thereof, e.g., as an application specific circuit.

[0177] For example, hardware for performing selected tasks according to embodiments of the application could be implemented. As software, selected tasks according to embodiments of the application could be implemented, e.g., using firmware or at least one software module being executed by a computer using any suitable operating system. In an exemplary embodiment of the application, one or more tasks according to embodiments of the method and / or system as described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes a volatile memory for storing instructions and / or data and / or a non-volatile storage, for example, a magnetic hard-disk and / or removable media to store

[0178] Any combination of one or more computer readable medium can be utilized in some embodiments of the application. The computer readable medium can be a computer readable signal medium or a computer readable storage medium. A computer readable storage medium can be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer readable storage medium include the following: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium can be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.

[0179] A computer readable signal medium can include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal can take any of a variety of forms, including, but not limited to, electro-magnetic, optical, or any suitable combination thereof. A computer readable signal medium can be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0180] Program code embodied on a computer readable medium can be transmitted using any appropriate medium, including but not limited to wireless, wired, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

[0181] Computer program code for carrying out operations of some embodiments of the application can be written in any combination of one or more programming languages, including an object oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages. The program code can execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer can be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection can be made to an external computer (for example, through the Internet using an Internet Service Provider).

[0182] The computer program instructions can also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks.

[0183] The computer program instructions can also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks.

[0184] The computer program instructions can also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks.

[0185] The computer program instructions can also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks. BRIEF DESCRIPTION OF DRAWINGS

[0186] Some embodiments of the application are described herein by way of example with reference to the accompanying drawings and images. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the application. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the application can be implemented.

[0187] In the drawings:

[0188] FIG. 1A is a flowchart of a general procedure for delivering ultrasound waves according to some embodiments of the application;

[0189] FIG. 1B is a schematic diagram showing the correlation between features of an ultrasound applicator and the Mean Time Between Failures (MTBF) of the applicator according to some exemplary embodiments of the application;

[0190] FIG. 1C is a flowchart of a procedure for starting and monitoring the start-up of an ultrasound applicator according to some exemplary embodiments of the application;

[0191] FIG. 2A is a schematic diagram showing the penetration of ultrasound energy into deep layers of the skin while cooling the skin surface according to some embodiments of the application;

[0192] FIG. 2B is a schematic diagram showing the penetration depth of the ultrasound waves according to some embodiments of the application;

[0193] FIG. 2C and 2D is a schematic diagram showing heating of large tissue volumes located deep in the skin according to some embodiments of the application;

[0194] FIG. 2E to 2H is a schematic diagram of different types of ultrasound transducers according to some exemplary embodiments of the application and the tissue volumes affected by the ultrasound transducers;

[0195] FIG. 2I is a schematic diagram showing heating of large spaced-apart tissue volumes deep in the skin by ultrasound transducers of a single applicator according to some embodiments of the application;

[0196] FIG. 3A is a schematic block diagram of a system for delivering ultrasound waves for skin treatment according to some embodiments of the application;

[0197] FIG. 3Bis a schematic diagram of a system and system components for delivering ultrasound for multiple skin treatments according to some embodiments of the application;

[0198] FIG. 3C is a flowchart of a skin treatment process according to some embodiments of the application;

[0199] FIG. 4A is a flowchart of a detailed process according to some embodiments of the application, including user actions when delivering ultrasound energy for multiple skin treatments;

[0200] FIG. 4B is a flowchart of a detailed process according to some embodiments of the application, including system actions when delivering ultrasound energy for multiple skin treatments;

[0201] FIG. 5A to 5C is a chart showing activation modes for a system for delivering ultrasound energy for multiple skin treatments according to some embodiments of the application;

[0202] FIG. 6A to 6B is a chart showing skin contact monitoring according to some embodiments of the application;

[0203] FIG. 6C to 6D is a chart showing impedance monitoring according to some embodiments of the application;

[0204] FIG. 6E is a flowchart of a process for identifying potential efficiency degradation of ultrasound energy generation and / or delivery according to some example embodiments of the application;

[0205] FIG. 6F is a flowchart of a process for modifying activation of one or more ultrasound transducers and / or at least one parameter of an ultrasound treatment according to impedance changes according to some example embodiments of the application;

[0206] FIG. 7A to 7C is a schematic diagram of a system including a console and an applicator for delivering multiple skin treatments according to some embodiments of the application;

[0207] FIG. 8A to 8C is a schematic diagram of an applicator according to some embodiments of the application;

[0208] FIG. 9A to 9B is a schematic diagram of a user interface of an applicator according to some embodiments of the application;

[0209] FIG. 10A to 10D is a schematic diagram showing components of an intensifier unit of an applicator according to some embodiments of the application;

[0210] FIG. 11A and 11B is a schematic cross-sectional view showing interactions between layers of an enhancer unit according to some embodiments of the application;

[0211] FIG. 12A to 12B is a schematic view showing welding a flat bar to the upper PZT electrode according to some embodiments of the application;

[0212] FIG. 13A to 13D is a schematic view of a flex PCB according to some embodiments of the application;

[0213] FIG. 14A to 14B is a schematic view of a holder of an enhancer unit according to some embodiments of the application;

[0214] FIG. 15A to 15D is a schematic view of a plurality of transducer PCBs of a power unit according to some embodiments of the application;

[0215] FIG. 15E is a schematic view showing collection and transmission of measurements from the enhancer to the console according to some exemplary embodiments of the application;

[0216] FIG. 16A is an image showing sealing of the applicator according to some embodiments of the application;

[0217] FIG. 16B to 16D is a schematic view of an applicator assembly and components according to some exemplary embodiments of the application;

[0218] FIG. 17 is a schematic view of an applicator and umbilical connection channel according to some embodiments of the application, showing connectors of the umbilical connection channel;

[0219] FIG. 18A to 18C is a schematic view of a console of a system for delivering ultrasound according to some embodiments of the application;

[0220] FIG. 19A is a schematic block diagram showing electrical power measurements of ultrasound channels according to some embodiments of the application;

[0221] FIG. 19B is a schematic view of an ultrasound power card according to some embodiments of the application;

[0222] FIG. 19C to 19E is a schematic view of a link between two or more ultrasound cards and a main board in the console according to some embodiments of the application;

[0223] FIG. 20 is a block diagram of a cooling system for a system for delivering multiple ultrasound waves according to some embodiments of the present application; and

[0224] FIG. 21A to 21B is a screenshot of a visual interface according to some embodiments of the present application. DETAILED DESCRIPTION

[0225] The present application, in some embodiments thereof, relates to an ultrasound system and, more particularly, but not exclusively, to an ultrasound system for skin treatment.

[0226] According to some embodiments, ultrasound energy is delivered in the form of multiple ultrasound waves to tissue layers located at different depths below the skin surface. In some embodiments, the ultrasound energy is optionally delivered in the manner of converging (focusing) or non-converging ultrasound waves. In some embodiments, the interaction of the ultrasound waves with the tissue generates a thermal effect for heating different tissue layers. In some embodiments, the heated tissue layers optionally change their shape, volume and texture. Optionally, the changes in the tissue layers affect the shape of the skin surface, for example, the skin surface above the heated layers, and can result in skin tightening and additional cosmetic effects. In some embodiments, an ultrasound transducer placed in contact with the skin optionally delivers the ultrasound energy through the skin surface to the deep tissue layers. In some embodiments, skin surface cooling prevents the skin surface from being damaged or injured by the heat generated by the interaction of the tissue with the ultrasound energy.

[0227] According to some embodiments, devices referred to as applicators deliver the ultrasound energy to the skin. In some embodiments, an applicator includes an ultrasound transducer connected to an ultrasound energy source. In some embodiments, an ultrasound transducer includes a PZT element. Alternatively, an ultrasound transducer includes other components configured to vibrate when energized. In some embodiments, coupling the ultrasound energy to the skin or tissue optionally heats a single skin or tissue volume. In some embodiments, the applicators are configured to support easy translation over the skin surface and application of the ultrasound to larger skin areas. In some embodiments, the applicators or system optionally provide ultrasound energy and skin temperature monitoring. In some embodiments, the monitoring of the treatment parameters provides the operator with real-time feedback related to the ultrasound treatment protocol.

[0228] A broad aspect of some embodiments is related to delivering ultrasound energy to multiple depths of the skin in a reliable, robust, and safe manner. In some embodiments, the ultrasound energy is delivered as part of a therapeutic treatment of the skin, for example, acne, scars, hypohidrosis, melanoma, basal cell carcinoma, etc. Alternatively, the ultrasound energy is delivered as part of a cosmetic non-therapeutic treatment of the skin. In some embodiments, in order to deliver ultrasound energy in a reliable, robust, and / or safe manner, the system, for example, the ultrasound applicator, is assembled and constructed to generate and deliver ultrasound energy over a period of at least two weeks, for example, at least 3 weeks, at least one month, when treating 2 or more subjects. Additionally, the system continuously or intermittently monitors the activity of the ultrasound applicator, for example, the activity of each ultrasound transducer during the activation, to identify potential degradation of the efficiency of ultrasound energy generation and / or delivery. For example, the system monitors one or more electrical parameters of the ultrasound transducers. In some embodiments, variations in the values of the monitored electrical parameters over time and / or between ultrasound transducers of the same applicator optionally indicate malfunctioning, for example, degradation, of one or more ultrasound transducers. Alternatively or additionally, variations in the values of the monitored electrical parameters over time and / or between ultrasound transducers optionally indicate use of the ultrasound applicator that is not in accordance with the authorized activation guidelines.

[0229] According to some embodiments, degradation of an ultrasound transducer, for example, at least one of the activity of the ultrasound transducer, the efficiency of the ultrasound transducer to convert electricity to vibrations, the efficiency of the ultrasound transducer to generate ultrasound energy, the efficiency of the ultrasound transducer to deliver ultrasound energy to the tissue, is detected by monitoring impedance or variations in impedance. In some embodiments, the degradation of the ultrasound transducer is detected by monitoring impedance or variations in impedance of each ultrasound transducer in an ultrasound applicator, for example, relative to a reference value or a baseline value, respectively.

[0230] Additionally or alternatively, the degradation of an ultrasound transducer is detected by monitoring at least one other electrical parameter or a change in the electrical parameter, such as the reflected power from the ultrasound transducer, the ratio between the power delivered to the ultrasound transducer and the power reflected from the ultrasound transducer, the capacitance of the transducer, the capacitance between the transducer and the skin, and the change in skin bioimpedance before and after an ultrasound energy pulse delivery. Changes in some of the above listed electrical parameters are expected to be highly correlated with changes in impedance, such as changes in the ultrasound transducer impedance. The following table lists optional changes in the electrical parameters due to transducer degradation:

[0231]

[0232] Additionally or alternatively, in order to deliver ultrasound energy in a reliable, robust and / or safe manner, the temperature of the ultrasound transducers and / or the skin contacting the ultrasound transducers is continuously or intermittently monitored during the activation of the ultrasound transducers. In some embodiments, changes in temperature values optionally indicate malfunction of one or more transducers not in accordance with authorized activation guidelines and / or use of the ultrasound applicator.

[0233] According to some embodiments, the ultrasound energy delivery system is configured to deliver ultrasound energy to the skin layer without damaging the skin surface. Alternatively or additionally, the system is intended to deliver ultrasound energy in an accurate and repeatable manner, such as to achieve a measurable and / or a safe effect. In some embodiments, the system is configured to accurately measure the effect of the delivered energy on the tissue and / or to deliver feedback to a user regarding the effect and / or the system operation in a clear manner.

[0234] According to some embodiments, the system is configured to accurately measure parameters related to the ultrasound and to generate power signals of the ultrasound. In some embodiments, the system is configured to monitor a thermal effect on the skin, such as by directly recording the skin temperature and / or by recording temperatures of applicator components, such as transducer temperature and / or transducer support temperature.

[0235] According to some embodiments, the system is configured to provide feedback to an operator of the system regarding the activity of the system components and the effect on the subject, such as online feedback during the ultrasound delivery.

[0236] According to some embodiments, the ultrasound applicator is configured to deliver at least 500 ultrasound pulses per day on average, for example at least 800 pulses per day, at least 1000 pulses per day, at least 2000 pulses per day, or any intermediate, smaller or larger number of pulses per day, optionally with an average mean time between failures (MTBF) of at least 21 days, for example at least 28 days, at least 2 months, at least 3 months, or any intermediate, shorter or longer period of time. In some embodiments, a failure of the connector means inability to deliver at least one of the plurality of ultrasound waves.

[0237] An aspect of some embodiments is related to shortening a distance between an ultrasound transducer and a radiating surface of an ultrasound applicator that contacts the skin. In some embodiments, the distance is shortened, for example, to allow efficient ultrasound energy delivery between the ultrasound transducer and the skin that contacts the radiating surface of the ultrasound applicator. Alternatively or additionally, the distance is shortened, for example, to allow accurate temperature measurements of the skin by temperature sensors located near the radiating surface of the applicator.

[0238] According to some example embodiments, the distance is shortened, for example, by attaching non-passivated electrical conductors or wiring on each of the ultrasound transducers between the ultrasound transducers and the radiating surface of the applicator. Alternatively, the distance is shortened by passing each of the ultrasound transducers through a base, for example a base holder, such that a bottom surface of the ultrasound transducer is positioned on the base. In some embodiments, the distance is shortened by coating the non-passivated electrical wiring and the ultrasound transducers with an electrically insulating polymer, for example a thin coating of Parylene.

[0239] An aspect of some embodiments is related to detecting changes in impedance values of an ultrasound transducer relative to a reference value during the activation of the ultrasound transducers. In some embodiments, the detected changes in impedance values optionally indicate a malfunction in the activity of the ultrasound transducer. In some embodiments, the impedance values and changes thereof are monitored continuously or intermittently during the activation of the ultrasound transducers. In some embodiments, the impedance values and changes thereof are monitored separately for each ultrasound transducer of the applicator.

[0240] An aspect of some embodiments is directed to preventing physical damage to the skin surface by attaching a planar strip having a flat surface to a surface of a PZT element of an applicator. In some embodiments, the flat surface of the wide strip faces and / or is shaped and sized for contacting a skin surface. In some embodiments, the flat surface of the strip, e.g., a surface that does not include any bumps and / or protrusions, for contacting a skin surface, is located between a PZT element and the skin surface.

[0241] According to some embodiments, the wide strip is an electrical conductor configured to conduct electrical current to the PZT element. In some embodiments, the wide strip electrical conductor is coated or made of a conductive material, e.g., silver. In some embodiments, the wide strip is attached to an upper surface of the PZT element, e.g., a surface of the PZT element facing the skin, by soldering, e.g., spark soldering. In some embodiments, the wide strip is not attached to the surface of the PZT element by soft soldering.

[0242] According to some embodiments, the wide strip includes a silver tape, e.g., a wide silver tape. In some embodiments, a width of the wide strip is in a range of 0.5 mm to 5 mm, e.g., 0.5 mm to 1.5 mm, 2 mm to 4 mm, 3 mm to 5 mm, or any intermediate, smaller or larger width. In some embodiments, the width of the wide strip is adjusted to a width of a surface of the PZT element facing the skin, e.g., an upper surface of the PZT element.

[0243] According to some embodiments, the wide strip has a larger cross-section relative to an electrical wire, e.g., for conducting higher electrical currents. In some embodiments, attaching the strip, e.g., a planar wide strip, to the PZT by soldering, rather than soft soldering, allows, e.g., prevents, the use of solder, and thus allows repeatable transmission block electrode area coverage.

[0244] An aspect of some embodiments is directed to placing a PZT element on a surface of a base layer made of a material having a controlled hardness. In some embodiments, the base layer includes conductive particles, e.g., electrically conductive particles, embedded in a non-conductive filler, e.g., a material that is not conductive to electrical power or has a lower than 30%, e.g., lower than 20%, lower than 10%, or any intermediate, smaller or larger percentage value, electrical power conductivity efficiency relative to the electrical conductivity efficiency of the conductive particles. In some embodiments, the non-conductive material is a non-conductive curing material, e.g., a non-conductive curing adhesive, configured to cure over time or in response to a force, a chemical or a physical reaction.

[0245] According to some embodiments, the base layer is positioned between at least one electrode of the PZT element and an electrical conductor, e.g., an electrically conductive wire and / or an electrically conductive foil. In some embodiments, the plurality of conductive particles are in mechanical contact with the electrical conductor and at least one PZT electrode and are configured to deliver electrical power between the electrical conductor and at least one PZT electrode.

[0246] According to some embodiments, the plurality of conductive particles are arranged as a monolayer within the non-conductive material between the at least one PZT electrode and the electrical conductor, e.g., a single close-packed layer of conductive particles. Optionally, the plurality of conductive particles are fixed as a monolayer within the non-conductive adhesive while in contact with the electrical conductor and the at least one PZT electrode, e.g., at different points of contact of the plurality of particles. In some embodiments, the plurality of conductive particles have a similar size and / or a similar diameter. Alternatively, the size and / or diameter of the plurality of particles varies by less than 20%, e.g., less than 10%, less than 5%, less than 2%, less than 1%, or any intermediate, smaller, or larger value.

[0247] According to some embodiments, at least 25% of the plurality of conductive particles, e.g., at least 50%, at least 80%, at least 90%, at least 95%, or any intermediate, smaller, or larger percentage of the plurality of particles are formed from a rigid core at least partially surrounded by a soft layer, the soft layer being softer relative to the rigid core. In some embodiments, at least one or both of the at least one PZT electrode and the electrical conductor contact the soft layer of each of the plurality of conductive particles at different points of contact.

[0248] According to some embodiments, at least 30% of the plurality of conductive particles, e.g., at least 50%, at least 80%, at least 90%, at least 95%, 100%, or any intermediate or smaller percentage of the plurality of particles have the same shape, e.g., have a spherical or circular shape. In some embodiments, at least 30% of the plurality of conductive particles, e.g., at least 50%, at least 80%, at least 90%, at least 95%, 100%, or any intermediate or smaller percentage of the plurality of particles are thermally conductive, e.g., allow heat to be conducted away from the PZT element.

[0249] According to some embodiments, at least 25% of the plurality of conductive particles, such as at least 50%, at least 80%, at least 90%, at least 95%, or any intermediate, smaller, or larger percentage of the plurality of particles are formed of a non-conductive rigid core, at least partially surrounded by a conductive layer. In some embodiments, the non-conductive rigid core is made of a non-conductive polymer or a combination of non-conductive polymers, such as polyurethane, polystyrene, polyimide, polyether ether ketone (PEEK), nylon. In some embodiments, the conductive surrounding layer comprises one or more of silver, copper, and tungsten, or any conductive metallic material or combination of metallic materials.

[0250] If mechanical forces are applied to the non-conductive layer at the PZT, a potential advantage of having a non-conductive material comprising a plurality of circular conductive particles having a diameter that is very similar or identical can be to allow a very uniform mechanical support of the PZT element. An additional potential advantage of the plurality of conductive particles can be to allow a high electrical conductivity between at least one PZT electrode and an electrical conductor through the plurality of conductive particles.

[0251] A potential advantage of the plurality of conductive particles having a rigid polymer core in contact with the PZT and a softer surrounding layer compared to particles formed entirely of a rigid material, such as a rigid polymer, can be to allow less attenuation of the PZT vibrations. An additional potential advantage of the plurality of circular conductive particles having a soft surrounding layer can be to reduce the attenuation of the PZT vibrations by allowing a point of contact between the plurality of circular conductive particles and the PZT having a minimal contact area due to the curved outer surface of the particles.

[0252] An additional potential advantage of arranging the plurality of conductive particles as a single layer between the PZT and an electrical conductor can be to increase the thermal conductivity of the PZT through the plurality of conductive particles, which is important for optimizing the skin cooling through the transducer surface.

[0253] In some embodiments, a surface of the PZT lower electrode is on a conductive film, such as a conductive adhesive film. In some embodiments, the conductive adhesive film comprises a double-sided conductive adhesive film. In some embodiments, the conductive adhesive film comprises particles, such as particles having a uniform diameter.

[0254] According to some embodiments, the distribution of the plurality of conductive particles within the glue film determines a hardness of the glue film. Optionally, pressing the PZT into the glue film disperses the plurality of particles to create a monolayer of conductive particles between the PZT and an underlying surface, such as a harder surface beneath the glue film. In some embodiments, the monolayer of conductive particles having a similar diameter is a uniform layer in thickness.

[0255] Some potential advantages of placing the PZT on a monolayer of conductive particles can include continuous and uniform mechanical support of the PZT to prevent the PZT from bending, for example against the skin surface, when pressing the PZT, better resistance to external mechanical stresses and pressing the PZT as part of the assembly process. An additional potential advantage can be the use of standard commercial PCB automated planar assembly techniques, for example for mass production.

[0256] An aspect of some embodiments is related to using a PZT element made of a hard material. In some embodiments, the PZT is made of a material having a mechanical quality factor (Qm) greater than 600, for example 800, 1000, 1200, or any intermediate, smaller or larger value. In some embodiments, the PZT element is made of a material having a Qm of at least 950, for example 1000, 1050, 1100, or any intermediate, smaller or larger Qm value. In some embodiments, using a PZT element having a high Qm value allows, for example, high energy conversion efficiency.

[0257] As used herein, the mechanical quality factor is a dimensionless factor that indicates the mechanical losses of a component under dynamic operating conditions.

[0258] Additionally or alternatively, the PZT is made of a material having a high Curie temperature, for example a Curie temperature of at least 250°C, for example 300°C, 320°C, 350°C, 380°C, or any intermediate, smaller or larger Curie temperature.

[0259] Some potential advantages of a PZT element made of a hard material and / or a material having a high Curie temperature can include that relatively high compressive stresses of up to 500 MPa, up to 400 MPa, up to 300 MPa, or any intermediate, smaller or larger value can be applied on the PZT without breaking, for example allowing mass production using PCB automated planar assembly techniques, for example pick-and-place techniques and / or allowing simple handling for manual assembly.

[0260] Additional potential advantages of using a PZT element made of a hard material and / or a material with a high Curie temperature can include mass production with standard dual component glue curing temperatures (100-120°C) and other standard commercial PCB automated planar assembly techniques, and application of wave soldering manufacturing processes in a range of 180-240°C for a short time (max 30 minutes), heating an applicator's booster assembly up to 50% of the Curie temperature = ~ 160°C without losing the piezoelectric properties.

[0261] An aspect of some embodiments is regarding PZT electrodes with a thin electrode layer having a thickness of up to 15 pm, such as up to 12 pm, up to 10 pm, up to 8 pm, up to 5 pm, or values within any intermediate, smaller or larger range.

[0262] Some potential advantages of using thin PZT electrodes of up to 10 pm can include allowing for a simple soldering process for electrical connections and / or a very good heat conduction on the PZT surface, for example, to prevent thermal disparities (hot spots) that can cause local thermal damage to the skin or the adhesive glue.

[0263] An aspect of some embodiments is regarding a polyimide PCB, such as a Kapton PCB positioned on top of at least one PZT element. In some embodiments, the polyimide PCB is a flex polyimide PCB, such as a flex Kapton PCB. In some embodiments, the flex Kapton PCB includes a thermistor circuit. In some embodiments, the flex Kapton PCB is thinner over the PZT elements than other areas, for example, to allow better energy transmission from the PZT elements to the tissue through the PCB.

[0264] According to some embodiments, a thickness of the flex Kapton PCB over the PZT elements is in a range of 10-35 pm, such as 10-20 pm, 18-28 pm, 20-35 pm, or values within any intermediate, smaller or larger range. In some embodiments, a thickness of the flex Kapton PCB in areas configured to be placed away from the PZT elements is in a range of 70-120 pm, such as 70-90 pm, 80-110 pm, 90-120 pm, or values within any intermediate, smaller or larger range. In some embodiments, no passivation layer is formed on the PZT areas in the PZT areas of the flex Kapton PCB and the thermistor circuit, such as a thermistor copper circuit.

[0265] According to some embodiments, electrical wiring or conductors located on top of or near the plurality of ultrasound transducers are not passivated, for example, to shorten a distance between the plurality of ultrasound transducers and the skin and / or to prevent loss of ultrasound energy due to the passivation layer. In some embodiments, electrical wiring and / or electrical conductors connected to each ultrasound transducer are optionally not passivated. Additionally or alternatively, electrical wiring and / or electrical conductors including temperature sensors, for example, thermistors located near the plurality of ultrasound transducers at the emitting surface of the ultrasound applicator, are not passivated.

[0266] According to some embodiments, the non-passivated electrical wiring and / or electrical conductors are insulated, for example, electrically insulated by an insulating layer. In some embodiments, the insulating layer insulates electrical wiring and / or electrical conductors to prevent interaction with fluids and / or air. Additionally, the insulating layer prevents short circuiting between non-passivated electrical wiring and / or electrical conductors that energize the plurality of ultrasound transducers and non-passivated electrical wiring and / or electrical conductors including the plurality of thermistors.

[0267] According to some exemplary embodiments, the insulating layer includes a strong adhesive, for example, a strong epoxy glue, configured to attach non-passivated electrical wiring and / or electrical conductors to the plurality of ultrasound transducers. Additionally, the insulating layer includes a thin coating of Kapton insulation having a thickness in a range of 12 to 50 pm, for example, 12 to 20 pm, 10 to 25 pm, or any intermediate, smaller or larger range of values, covering electrical wiring and / or electrical conductors and the plurality of ultrasound transducers. In some embodiments, the thin coating of Kapton is applied in a gaseous form under vacuum conditions. In some embodiments, the insulating layer includes a layer of parylene, which is a trade name for a variety of chemical vapor deposition poly(p-xylylene) polymers, most commonly the polymer parylene C, used as a moisture and dielectric barrier, covering the Kapton and located between the plurality of ultrasound transducers and a skin surface.

[0268] Some potential advantages of the flex Kaptan PCB can be to seal the enhancer face from water / moisture / ultrasound gel, etc. Additionally, the relatively small thickness can allow the ultrasound energy to pass through the flex PCB material with negligible energy loss. The relatively rigidity of the polyimide can resist various physical impacts from the environment, thereby maintaining the seal. Additionally, the flex Kaptan PCB allows (1) to be manufactured in standard, mass production methods to reduce production costs, and (2) to be electrically isolated from the skin / surroundings with a dielectric breakdown voltage of 300 volts to 1500 volts, such as 300 volts to 800 volts, 600 volts to 1200 volts, 1000 volts to 1500 volts, or any intermediate, smaller, or larger value.

[0269] According to some embodiments, the flex PCB is flipped so that the circuitry does not face the skin. In some embodiments, the flex PCB is glued to the PZT and the frame, for example, to allow the thermistors to be positioned in place between the PZT elements, and the circuitry connectors reach the connectors in the applicator main PCB with the correct length.

[0270] Some potential advantages of the interaction between a flex PCB, such as a thin flex PCB, and the thermistors can be fast heat transfer from the skin to the thermistors, for example, to allow constant updating of the temperature measurements of the skin. Additionally, the arrangement of the thermistors can allow the flex to be positioned in place on the frame using the PZT, for example, by positioning the thermistors in specific grooves in the frame. The flex PCB can also allow for simple electrical connection of the flex circuitry to the applicator main PCB, which optionally simplifies the assembly process.

[0271] An aspect of some embodiments is related to gluing the flex PCB to the PZT by applying a glue, pressing, and curing in an oven. In some embodiments, the glue, such as an epoxy glue, is pressed during the curing process. In some embodiments, the glue comprises the EPO-TEK® 353ND epoxy glue. In some embodiments, the glue is applied between the PZT, the frame, and the flex prior to pressing, such as horizontal pressing or lateral pressing. In some embodiments, during the curing process, the oven is heated to a temperature in a range of 100 °C to 150 °C, such as 100 °C to 130 °C, 110 °C to 140 °C, 120 °C to 150 °C, or any intermediate, smaller, or larger range of temperatures.

[0272] An underlying advantage of pressing the glue during the curing process can be to allow the flexure glue to be adhered to the PZT silver electrodes with a very thin (~20 pm) layer of glue, thus minimizing the ultrasonic energy loss in the glue layer. An underlying advantage of using the EpoTEK ND353 glue is that it can provide good adhesion of the flexure PCB to the PZT silver electrodes. An additional underlying advantage of using the EpoTEK ND353 glue is that it can mechanically secure and support the entire structure of silver bars and PZT elements, which are weakly supported on the soft conductive glue and particle film.

[0273] An aspect of some embodiments relates to a frame configured to at least partially cover the holder, having smooth rounded edges. In some embodiments, an outer surface of the frame has smooth rounded edges, for example, allowing tight bonding of the flexure PCB on the frame within a sufficiently large bend radius of the flexure copper lead circuit, for example, to prevent damage to the copper leads. In addition, the frame having smooth rounded edges allows, for example, a good water-tight seal between the frame and the outer cover by the gasket, and mass production with injection molding manufacturing.

[0274] An aspect of some embodiments relates to a holder having PZT elements, a width of the holder is greater than a width of a surface of a PZT element contacting the holder. In some embodiments, the width of the surface of the holder on which the PZT is placed is at least 10% wider than a width of a surface of the PZT element contacting the holder. In some embodiments, a surface of the holder shaped and sized to attach to a PZT element has a width in a range of 1.3 mm to 2 mm, for example, 1.3 mm to 1.5 mm, 1.4 mm to 1.7 mm, 1.6 mm to 1.8 mm, 1.7 mm to 2 mm, or any intermediate, smaller or larger width. In some embodiments, a width of a surface of the PZT element in contact with the holder is in a range of 0.8 mm to 1.2 mm, for example, 0.8 mm to 1 mm, 0.9 mm to 1.1 mm, 1 mm to 1.2 mm, or any intermediate, smaller or larger range of values. 1.6 mm wide, rather than 1 mm wide like the PZT element.

[0275] A potential advantage of having a wider holder surface compared to a PZT element width can be to allow ND353 glue to accumulate on the sides of the PZT elements for better mechanical support and adhesion of the PZT to the holder surface from the PZT sides for sealing the PZT from p-xylene permeation between the PZT electrodes and the glue, and to allow small alignment errors to occur when positioning the PZT on the holder surface.

[0276] An aspect of some embodiments is regarding electrically isolating a PZT element and its electrical wiring from other PZT elements and / or from the holder. In some embodiments, a copper strip that is electrically connected to a PZT electrode is electrically isolated from the holder, for example from the aluminum holder. Optionally, the copper strip is isolated from the holder by a non-conductive glue film and / or a passivation of the aluminum surface.

[0277] A potential advantage of electrically isolating a PZT element can be to allow individual measurement of the capacitance and / or impedance of each PZT without errors / noise from other PZT elements, and optionally without the capacitive effect of the water electrolyte on the flex outer surface. An additional potential advantage can be to allow different transducers to operate at different phases and / or at different frequencies.

[0278] An aspect of some embodiments is regarding having a main applicator with a PCB that has a rigid-flex-rigid-flex-rigid PCB, optionally with 50 Ohm matching in all parts, for example to allow bending of the PCB structure to fit on the holder structure, to allow a simple assembly process and to allow transmission of the RF signals in the flex.

[0279] An aspect of some embodiments is regarding a flex part of a PCB that has RF power channels grounded on both sides of the flex part, for example to allow low EMC, low interference or multiple variations of capacitance and impedance of the channels, and to not require connectors and / or coaxial soldering.

[0280] An aspect of some embodiments is regarding positioning the solder pad of the applicator main PCB on a "pole" on each side of the PZT, for example to allow shorter distance from the PZT to the bottom copper and top silver of the pad, easier assembly, less EMC, and less parasitic capacitance and / or impedance variations.

[0281] One aspect of some embodiments is a flex PCB with wires for measuring the temperature of the holder separately from the temperature of the PZT elements. In some embodiments, a "RF phase pole" of the applicator PCB includes a short extension flex on which the holder temperature thermistor is positioned. In some embodiments, the flex tip + thermistor is seated in a hole on the holder side and glued with a thermally conductive glue.

[0282] The potential advantages of a flex PCB with a separate flex wire for measuring the holder temperature can include simple assembly of the booster for measuring the holder temperature, quick planar assembly of the applicator PCB + holder thermistor, optionally without manual soldering, and transfer of the thermistor reading to the PCB electrical connectors through a flex part.

[0283] One aspect of some embodiments is a rigid board of the flex PCB that includes connectors to external wiring. In some embodiments, the rigid board of the flex PCB includes one or more connectors, such as push connectors, including RF, communication, and / or a switch. Optionally, the rigid board includes at least one indicator configured to deliver a human detectable indication, such as an LED. Additionally or alternatively, the rigid board includes at least one flat connector.

[0284] The potential advantages of a rigid board of a flex PCB with connectors can be to allow simple assembly with the applicator umbilical channel, and with the switch and / or with the applicator cover. An additional advantage can be to allow simple connection of the flex circuit for thermistor readings.

[0285] One aspect of some embodiments is a rigid board of the flex PCB that includes one or more of a measurement circuit, analog to digital (A2D) sampling, and / or SPI communication to allow, for example, transmission of the temperature and button signal readings from the applicator to a console.

[0286] The potential advantages of a rigid board with one or more of a measurement circuit, analog to digital (A2D) sampling, and / or SPI communication can be to reduce or eliminate the effects of EMC noise or capacitance errors on the accuracy of the readings transmitted to the console, to eliminate a need for wires for analog readings, to reduce EMC effects, and to allow integration of additional signals in the future, if needed.

[0287] One aspect of some embodiments is related to coating the described booster assembly with parylene, such as parylene-C. In some embodiments, the spacing between the frame and the holder allows, for example, the coating to penetrate into the inner cavity between the frame and the holder and optionally uniformly cover all surfaces.

[0288] Potential advantages of a parylene coating can include biocompatibility of the applicator face that touches the patient's skin, electrical isolation of all the exposed conductive surfaces and protection from corrosion within the frame cavity, mechanical stiffening and stabilization of the multiple thin silver strips and the PZT positioning, increased electrical isolation of the applicator face from the skin / surroundings, and / or increased sealing to prevent water and humidity penetration through the applicator face.

[0289] One aspect of some embodiments is related to using standard electrical connectors between a console and an applicator connection channel, such as an umbilical connection channel, for RF transmission and impedance measurements.

[0290] Potential advantages of using standard connectors can be lower cost, simple assembly, no need for soldering, easy connection between the applicator and the umbilical connection channel, such as by snapping the connectors into sockets on the applicator PCB.

[0291] One aspect of some embodiments is related to sealing both ends of an umbilical connection channel that connects an applicator and a console to prevent air penetration. In some embodiments, the umbilical connection channel includes cooling liquid tubes, such as water tubes. In some embodiments, the umbilical connection channel is sealed with a non-acidic sealant, such as a non-acidic RTV silicone seal, to prevent humid air from entering an inner cavity of the umbilical connection channel.

[0292] Potential advantages of sealing an umbilical connection channel that includes cooling liquid tubes to air can be to minimize condensation of water on the water tubes from the air inside the umbilical, to minimize water dripping from the umbilical air cavity into the applicator space, and to mechanically position the multiple cables to prevent twisting in case of condensation.

[0293] One aspect of some embodiments is related to individually electrically shielding multiple cables within the umbilical connection channel. In some embodiments, an additional electrical shield covers all the cables together and is optionally electrically connected to their shields. In some embodiments, the external shield is electrically connected to the console chassis instead of to the RF or signal ground.

[0294] A potential advantage of individually electrically shielding the multiple electrical cables can be to achieve a sufficient EMC shielding according to regulatory requirements.

[0295] An aspect of some embodiments relates to a conductive elongated pin in a connection between the umbilical connection channel and the console. In some embodiments, the pin is electrically connected to at least one electrical shield of the umbilical connection channel, for example to at least one electrical shield of a plurality of electrical wires inside the umbilical connection channel, and / or to an electrical shield surrounding two or more electrical wires inside the umbilical connection channel. In some embodiments, the elongated pin extends from the umbilical connection channel to the console, for example to a connection port of the console.

[0296] An aspect of some embodiments relates to a multi-pin connector, for example a connector with 20-70 pins, for example 20-50 pins, 40-70 pins, or any intermediate, smaller or larger number of pins, of the umbilical connection channel configured to connect to a connector of the console, for example a 50-pin D-connector. In some embodiments, using a multi-pin connector, for example a standard multi-pin connector, for example, reduces cost due to use of standard parts, simple assembly without soldering, simple applicator assembly by snapping the multi-pin connector into a socket of the applicator PCB.

[0297] An aspect of some embodiments relates to a umbilical connection connector molded with soft silicone around the multi-pin connector to the console. For example, covering the connector and a non-insulated portion of the electrical wires. In some embodiments, the molding with the soft silicone allows for electrical isolation, for example in case water penetrates the umbilical connection channel or condensation, and / or prevents corrosion.

[0298] An aspect of some embodiments relates to sealing the booster assembly from water and air. In some embodiments, the booster, for example after a parylene-C coating, is covered by an external applicator cover and a gasket. In some embodiments, a non-acidic silicone, for example a non-acidic RTV silicone, is positioned around an air gap or any other gap between the external cover and the heat exchanger to seal the gap.

[0299] Potential advantages of sealing the powered assembly from air and water can be preventing water condensation and / or icing on the booster holder, preventing air humidity or water condensation on the water tubes, preventing water or other liquids from penetrating the frame space and the PZT elements nearby, which can cause one or more of changes in the PZT mechanical support or stresses, electrical impedance, and thermistor measurement sensitivity.

[0300] One aspect of some embodiments is to secure a rigid plate of the flex PCB to at least one applicator cover, for example to an inner surface of the at least one applicator cover. In some embodiments, the rigid plate is secured to the applicator cover, for example to the inner surface of the applicator cover, with a plurality of screws. In some embodiments, a plurality of pins of the cover are connected to the heat exchanger while securing the booster assembly position between the cover and the heat exchanger.

[0301] Potential advantages of securing the rigid plate of the flex PCB to an inner surface of the cover can be to mechanically support the flex PCB to prevent mechanical stresses and damage to the flex portion of the flex PCB and the thermistor flex, to provide mechanical support against pulling forces exerted by the umbilical connection channel on the flex PCB.

[0302] One aspect of some embodiments is to secure the inner portion of the applicator in silicone. In some embodiments, once the booster assembly and wiring are positioned in a desired orientation within the applicator, they are covered in silicone. In some embodiments, the electrical connectors of the top cap switch and LED are connected with the PCB rigid plate; the umbilical connection channel insert is positioned in a desired orientation, and the left applicator cover is closed and glued with a glue. In some embodiments, the applicator is positioned at angles of 30 and 60 degrees or any intermediate, smaller or larger range, then soft silicone molding material is added to the applicator head to fill it to the opening of the upper cover containing a user interface. In some embodiments, silicone is added to a limited volume within the applicator, for example, to reduce weight.

[0303] Potential advantages of filling an inner cavity of the applicator enclosure containing the booster and electrical wiring can be to prevent water condensation on the water tubes due to penetration of humid air, to prevent water droplets from falling and penetrating the electrical connectors within the applicator, for example electrical connectors on the applicator PCB and the TEC connectors, to electrically isolate the inner components of the applicator, to prevent water droplets from dripping from the applicator head when condensation is formed, and to mechanically stabilize and harden the applicator structure.

[0304] One aspect of some embodiments is to a user interface of the applicator that is water sealed, for example to seal the user interface and / or inner cavity from external liquids, for example various sweat and ultrasound gel.

[0305] An aspect of some embodiments relates to using an adhesive instead of closing a housing of the applicator by a plurality of screws, for example, to prevent the applicator housing from opening and closing without indication.

[0306] An aspect of some embodiments relates to maintaining a near-sine power signal in an output of a low-pass filter from an ultrasonic PCB by positioning a plurality of air coils on the high-pass filter. In some embodiments, the plurality of air coils allows, for example, correct power measurement, converting high efficient energy to ultrasonic (US) power. In some embodiments, the plurality of air coils allows, for example, measuring electrical power according to a simple capacitor charging, which can be easily measured at a low sampling rate.

[0307] An aspect of some embodiments relates to performing forward and / or reverse power measurements on an ultrasonic power card. Additionally, performing impedance measurements on the ultrasonic power card.

[0308] An aspect of some embodiments relates to an electrical shield on the plurality of air coils of the ultrasonic (US) low-pass filter. In some embodiments, the electrical shield on the plurality of air coils is grounded.

[0309] An aspect of some embodiments relates to an external electrical shield on the entire US power card, for example, at least 50%, for example, at least 70%, at least 85%, or any intermediate, smaller or larger percentage on the US power card. In some embodiments, the external electrical shield is connected to the chassis of the console, instead of being grounded.

[0310] According to some embodiments, the PCB RF ground is not connected to the chassis of the console.

[0311] An aspect of some embodiments relates to connecting a plurality of US power cards directly to a backplane PCB board of the console, for example, without a wire harness, thereby reducing a plurality of EMC emissions and / or reducing the complexity of building the system on the manufacturing factory.

[0312] An aspect of some embodiments relates to a condenser of an ultrasonic system cooling system located at a lower part of a console. In some embodiments, the condenser comprises a pump, a fan, and a coolant storage device. In some embodiments, the condenser frame is not electrically connected to a frame, for example, a chassis of the console. In some embodiments, the coolant storage device comprises anti-freeze coolant.

[0313] An aspect of some embodiments is EMC shielding with respect to multiple console components. In some embodiments, the console components include at least one surface of the condenser, multiple US power cards, and / or at least one rotating fan included in the console. In some embodiments, the EMC shielding is made of multiple ferrites.

[0314] An aspect of some embodiments is a leaf spring for a console socket for connecting an applicator. In some embodiments, the leaf spring allows, for example, good electrical contact between a pin of a umbilical connection channel of a shield connected to the applicator and a console frame, for example a chassis.

[0315] An aspect of some embodiments is a standard multi-pin socket (30-50 pins), for example a 50-pin D-socket, for a console socket for connecting an applicator. In some embodiments, the multi-pin socket is used for delivering multiple radio frequency (RF) signals to the applicator. Using a multi-pin socket can, for example, reduce costs due to use of multiple standard parts, simple assembly without soldering, and a simple assembly of the applicator.

[0316] An aspect of some embodiments is a display of a console positioned at an angle of about 45 degrees with respect to a longitudinal axis of the console. In some embodiments, positioning the display at a 45 degree angle allows, for example, easy visualization of the display by a user of the ultrasound energy delivery system.

[0317] Before at least one embodiment of the application is explained in detail, it is to be understood that the application is not limited in its application to the details of construction and the arrangement of the components and methods set forth in the following description or illustrated in the drawings and / or the Examples. The application is capable of other embodiments or of being practiced or carried out in various ways.

[0318] Exemplary general procedure

[0319] According to some example embodiments, ultrasound energy is delivered in the form of a plurality of ultrasound waves into a plurality of deep tissue layers of the skin beneath the skin surface. In some embodiments, the plurality of ultrasound waves, e.g., a plurality of non-converging ultrasound waves, are used to heat a plurality of deep tissue layers of the skin. In some embodiments, healing of the plurality of heated deep tissue layers affects the shape of the skin surface, e.g., the skin surface above the plurality of heated layers. In some embodiments, healing, e.g., recovery of the plurality of deep tissue layers, results in skin tightening. In some embodiments, heating of the plurality of deep tissue layers is performed while cooling the skin surface, e.g., to prevent injury to the skin surface from the heat generated by the delivered plurality of ultrasound waves. In some embodiments, the delivery of ultrasound energy is used for cosmetic treatments of humans and non-human mammals. Reference is now made to FIG. 1, which depicts a general procedure for skin treatment using ultrasound energy. FIG. 1A

[0320] According to some example embodiments, at block 102, a surface of an ultrasound applicator is cooled, which is shaped and sized to contact the skin surface. In some embodiments, the applicator surface is cooled to a temperature below 10°C, e.g., below 8°C, below 5°C, below 2°C, or any intermediate, smaller, or larger value.

[0321] According to some example embodiments, the temperature of the ultrasound applicator surface is monitored during cooling, e.g., to prevent the formation of ice shards on the surface. In some embodiments, when ice shards are detected, a defrosting procedure is initiated, e.g., to remove the ice shards. Optionally, the defrosting procedure is initiated automatically based on changes in the surface temperature, impedance values, and / or conductivity values.

[0322] According to some example embodiments, once the applicator surface reaches a desired temperature level, at block 104, the applicator surface is placed in contact with the skin. In some embodiments, the skin temperature is monitored when the applicator surface, e.g., a cold applicator surface, contacts the skin surface. In some embodiments, at block 104, the skin temperature is monitored while the applicator surface is in contact with the skin surface, e.g., to prevent the formation of cold burns or any damage to the skin caused by the low temperature.

[0323] ​According to some example embodiments, the applicator comprises one or more ultrasound transducers, for example arranged in an array of multiple ultrasound transducers, the array of multiple ultrasound transducers being located in proximity to and optionally below the surface of the applicator, the applicator being configured to be in contact with the skin. In some embodiments, the array of multiple ultrasound transducers is a planar array. In some embodiments, the surface of the applicator comprises one or more insulating coatings, for example one or more insulating coatings configured to insulate the one or more ultrasound transducers from fluids, for example sweat and / or air. Alternatively or additionally, the one or more insulating coatings are configured to insulate the array of multiple ultrasound transducers from the skin surface when the surface of the applicator is in contact with the skin. In some embodiments, the skin is cooled by delivering hypothermia from the applicator through the one or more insulating layers to the skin.

[0324] According to some example embodiments, at block 106, multiple ultrasound waves are emitted. In some embodiments, the multiple ultrasound waves are emitted while the surface of the applicator is in contact with the skin surface. In some embodiments, the multiple ultrasound waves are emitted while the applicator cools the skin surface. In some embodiments, the multiple ultrasound waves are emitted from the array of multiple ultrasound transducers of the applicator, through the one or more insulating layers into the skin.

[0325] According to some example embodiments, at block 110, the emitted multiple ultrasound waves generate a thermal effect in multiple deep tissue layers of the skin. In some embodiments, the multiple ultrasound waves affect multiple large and deep tissue volumes in the skin. In some embodiments, the size and shape of the multiple large tissue volumes are determined based on the size and shape of an emission surface of each ultrasound transducer, for example a length and / or a width of an emission surface of the ultrasound transducer facing the skin. Alternatively or additionally, the size and shape of the multiple large tissue volumes are determined based on at least one parameter of the transmitted waves, for example an amplitude, a frequency and / or a duration of the transmitted waves.

[0326] According to some example embodiments, a pattern of arrangement of the multiple ultrasound transducers emitting the multiple ultrasound waves, for example a distance between adjacent transducers, a distance between a first and a last ultrasound transducer in an array of multiple ultrasound transducers, determines the size and shape of the treated skin surface, for example a cosmetically treated skin surface.

[0327] According to some example embodiments, during the delivery of ultrasound energy into the skin by the plurality of emitted ultrasound waves, an activity of the ultrasound treatment system is monitored at block 108. Alternatively or additionally, the effect of the delivered ultrasound energy and / or the cooling of the skin is monitored at block 108. In some embodiments, the activity of the ultrasound treatment system includes the amount of energy delivered, at least one parameter of the method of the delivery, one or more electrical parameters related to the US signal delivered to the plurality of ultrasound transducers, such as impedance and signal shape, and / or the temperature of at least one component of the cooling system, such as applicator temperature, transducer temperature, contact and / or pressure between the applicator and the skin surface.

[0328] According to some example embodiments, the effect of the delivered ultrasound energy includes the temperature of the skin surface, estimated temperature in the plurality of deep tissue layers, estimated temperature distribution in the plurality of deep tissue layers, estimated penetration depth of the plurality of ultrasound waves, estimated shape and size of the plurality of affected tissue volumes in the plurality of deep tissue layers.

[0329] According to some example embodiments, the applicator is repositioned on the skin surface at block 112. In some embodiments, the applicator is positioned on a different area of the skin, for example once a predetermined amount of energy is delivered to a first skin area and / or once a desired effect is achieved in the first area. In some embodiments, the applicator is repositioned according to a previously determined treatment plan, for example, treating a planned portion of a number of skin areas in an anatomical region, for example, face, neck, submental region or two or more anatomical regions.

[0330] Example applicator mean time between failures

[0331] According to some example embodiments, the applicator of the ultrasound system is designed to be robust and reliable, for example, to allow for a long MTBF. In some embodiments, the applicator is used for a period of at least 21 days, for example at least 28 days, at least 2 months, at least 3 months or any intermediate, shorter or longer period of time, when delivering an average of at least 500 ultrasound pulses per day, before a failure occurs. Reference is now made to FIG. 1B depicting a plurality of features of the ultrasound applicator that contribute to a prolonged MTBF, according to some example embodiments.

[0332] According to some example embodiments, the applicator is used to deliver a plurality of therapeutic ultrasound waves, e.g., a plurality of non-converging ultrasound waves, into a plurality of layers of the tissue. In some embodiments, the energy delivered by the ultrasound applicator heats the plurality of skin tissue layers and the surface of the skin in contact with the applicator, e.g., with the ultrasound transducers that generate and deliver the plurality of ultrasound waves.

[0333] According to some example embodiments, in order to alleviate the pain felt by the patient during the treatment, a treatment area on the skin of the patient that is in contact with the applicator is covered with a pain-alleviating substance, e.g., a pain-alleviating cream.

[0334] One of the problems when using the applicator in a humid or wet environment, e.g., due to sweat or the pain-alleviating cream, can be the penetration of liquid and / or moisture into the applicator housing, which can interfere with the normal operation of the applicator. In some embodiments, in order to prevent damage to the internal components of the applicator by fluids and moisture from the air and the skin, the applicator housing is sealed to prevent fluids from the outside.

[0335] According to some example embodiments, applicator sealing 122 includes sealing the booster assembly, which includes the plurality of ultrasound transducers and electrical wiring, from liquids and / or air, e.g., by a cover that prevents direct contact with the booster assembly. Additionally, the plurality of ultrasound transducers, e.g., the plurality of PZT elements, are sealed, e.g., by at least one sealing layer that prevents direct contact between the plurality of ultrasound transducers and the skin surface. Additionally, openings and / or gaps within the applicator housing are sealed with a sealant, e.g., a silicone sealant. In some embodiments, the silicone includes a room temperature vulcanizing (RTV) silicone.

[0336] According to some example embodiments, in order to prevent damage to the skin surface, low temperatures are delivered by the plurality of ultrasound transducers to the skin surface that is in contact with the plurality of transducers. In some embodiments, the applicator includes an internal cooling system that includes delivering a coolant fluid through the inner cavity of the applicator in relative proximity to the electrical wiring. One of the problems when using an ultrasound applicator with an internal flow of coolant fluid can be internal condensation, which can affect the electrical wiring within the applicator and interfere with the normal operation of the applicator.

[0337] According to some example embodiments, in order to have reliable electrical wiring 124, the internal electrical wiring is insulated from the cooling liquid of the multiple tubes. In some embodiments, the gaps within the applicator are filled with an electrically non-conductive filler, such as a silicone filler. In some embodiments, the silicone filler comprises RTV silicone. In some embodiments, the filler in contact with the multiple cooling liquid tubes within the applicator prevents, for example, condensation on the multiple tubes and / or electrical wiring contact with the multiple tubes.

[0338] Additionally, in some embodiments, the multiple electrical wires leading to the multiple ultrasound transducers of the enhancer are grouped in a flex PCB and are not physically separated from each other, for example, to increase the reliability of the applicator electrical wiring.

[0339] According to some example embodiments, one of the multiple problems when heating the skin as part of a cosmetic and / or a therapeutic procedure is how to produce a desired effect without damaging the skin surface. In some embodiments, the skin surface can be damaged when one or more of the multiple transducers does not function properly and / or when the applicator, for example, at least one transducer, over-heats the skin surface. Furthermore, in some embodiments, for example, if one or more of the multiple transducers is not placed in contact with the skin surface, the produced effect can not be a desired effect.

[0340] According to some example embodiments, in order to produce a desired effect on the skin tissue, accurate measurements of multiple parameters related to the multiple transducer activity 126 in the applicator are performed. In some embodiments, the measurements of the multiple parameters of the multiple transducer activity comprise measuring at least one electrical parameter of the multiple transducers, such as current, voltage and / or impedance. Alternatively or additionally, the measurements of the multiple parameters related to the multiple transducer activity 126 comprise measurements of the multiple transducer temperature and / or measurements of the skin surface temperature. FIG. 1B

[0341] ​According to some example embodiments, in order to accurately measure transducer activity, electrical wiring to the plurality of transducers is separate from electrical wiring of a plurality of temperature sensors, for example, thermistors configured to measure the temperature of one or more ultrasound transducers and / or the temperature of the skin surface. Furthermore, in some embodiments, thermistors measuring skin surface temperature are placed near, and optionally between, ultrasound transducers on an ultrasound emitting surface of the applicator in contact with the skin. In some embodiments, the thermistors are covered by a thin layer of insulating material, the material being thin enough, for example, to allow accurate temperature sensing of the skin surface.

[0342] According to some example embodiments, in order to maintain normal operation of the applicator, the structure of the applicator, for example, the mechanical support of the plurality of ultrasound transducers, is robust. In some embodiments, having a robust mechanical support 128 is important, for example, to maintain electrical connection to and from the plurality of ultrasound transducers over extended periods of time.

[0343] According to some example embodiments, in order to obtain a robust mechanical support, the plurality of ultrasound transducers are fixed to electrical contacts, for example, electrodes, in a firm and stable manner, preventing relative movement of the plurality of transducers when the skin exerts pressure on the applicator surface. In some embodiments, in order to maintain a robust mechanical support over time, the plurality of transducers are pressed into a layer of adhesive containing a layer of electrically conductive particles. In some embodiments, pressing the plurality of transducers into the adhesive layer fixes the position of the plurality of transducers while maintaining proper electrical connection between the plurality of transducers and electrical wiring of the ultrasound applicator.

[0344] According to some example embodiments, additional robustness is achieved, for example, by the filler of the ultrasound applicator inner cavity. In some embodiments, the filler prevents movement of electrical and non-electrical components within the applicator.

[0345] Example activation and monitoring of an ultrasound applicator

[0346] According to some example embodiments, in order to provide a reliable treatment, for example, a cosmetic non-therapeutic treatment, the activation of an ultrasound transducer is monitored. In some embodiments, the activation of the ultrasound transducers of the ultrasound applicator is monitored, for example, according to predetermined parameter values and / or criteria, for example, to identify whether and when one or more ultrasound transducers are not functioning properly. Reference is now made to FIG. 1C depicting activation and monitoring of an ultrasound applicator, according to some example embodiments of the present application.

[0347] According to some example embodiments, at block 140, an ultrasound applicator is identified. In some embodiments, an identification (ID) tag, e.g., an ID code, of the ultrasound applicator is read and inserted into a memory of a control unit, e.g., a console. In some embodiments, the ID tag includes ID information of a specific ultrasound applicator. In some embodiments, the ID tag is read by a reader of the console. Optionally, the ID tag includes a radio frequency identification (RFID) tag and the console includes a RFID reader configured to read the RFID tag of the ultrasound applicator. Optionally, the ultrasound applicator includes an electronic circuit including the ID information, e.g., when the ultrasound applicator is coupled to the console, and a control circuit of the console is configured to read the ID information.

[0348] According to some example embodiments, the ID information includes information associating the ultrasound applicator with a specific manufacturer, a number of ultrasound pulses generated by the ultrasound applicator, a manufacturing date, manufacturing information, a type of ultrasound applicator and / or setting or calibration information of the ultrasound applicator.

[0349] According to some example embodiments, a control circuit of the console determines whether the ultrasound applicator is an authorized applicator based on the ID code or ID information associated with the applicator. In some embodiments, the control circuit determines whether the ultrasound applicator is an authorized applicator by determining a correlation between the ID code or information associated with the ultrasound applicator and at least one indication stored in a memory of the console and / or a memory of a remote device, e.g., a remote computer, a remote server or a cloud storage. In some embodiments, if the ultrasound applicator is not authorized, the control circuit of the console prevents the activation of the ultrasound applicator, e.g., by locking a software interface with the user. Alternatively, the control circuit of the console prevents the activation of the ultrasound applicator, e.g., by mechanically locking at least one activation button in the console.

[0350] According to some example embodiments, at block 142, the console, e.g., the control circuit, determines to activate the ultrasound applicator. In some embodiments, if the ultrasound applicator is authorized, the console, e.g., based on the ID information associated with the ultrasound applicator, determines to activate the ultrasound applicator.

[0351] According to some example embodiments, at block 144, the console initiates the ultrasound applicator, e.g., a plurality of ultrasound transducers of the ultrasound applicator. In some embodiments, the ultrasound applicator is initiated to generate at least 30,000 pulses of ultrasound energy over a time period of at least 1 week, e.g., at least 2 weeks, at least 1 month, or any intermediate, shorter or longer time period. In some embodiments, when treating two or more subjects, the ultrasound applicator optionally generates at least 30,000 pulses.

[0352] According to some example embodiments, at block 146, at least one initiation parameter of the ultrasound applicator is monitored. In some embodiments, at least one initiation parameter is monitored during the initiation of the plurality of ultrasound transducers, e.g., as described at block 144. In some embodiments, at block 146, at least one initiation parameter of two or more ultrasound transducers of the ultrasound applicator is monitored. In some embodiments, the at least one initiation parameter is monitored by a console, e.g., by a control circuit. In some embodiments, the at least one initiation parameter includes at least one of impedance, voltage, current, and number of pulses generated by the ultrasound applicator in total and / or by each of the plurality of ultrasound transducers. In some embodiments, at least one initiation parameter is monitored separately for each of the two or more ultrasound transducers. Optionally, at least one initiation parameter is monitored by measuring a plurality of values of the initiation parameter of each ultrasound transducer and determining a correlation between the plurality of measured values and at least one reference value.

[0353] According to some example embodiments, at block 148, at least one indication is generated and delivered based on the results of the monitoring. In some embodiments, at least one indication is a human detectable indication. Optionally, at least one indication includes an audio and / or a visual indication. In some embodiments, at least one indication is delivered to a user of the ultrasound system. Alternatively or additionally, the indication is sent to a remote device, e.g., to allow monitoring of the ultrasound applicator activity by a manufacture of the ultrasound applicator and / or the ultrasound system.

[0354] According to some example embodiments, at least one indication includes an alarm signal, e.g., an alarm signal generated if the monitored at least one initiation parameter is not within a range of expected values. In some embodiments, the alarm signal is generated and delivered to a user of the ultrasound system. Alternatively, the alarm signal is sent to a remote device.

[0355] According to some example embodiments, at block 150, the console optionally, e.g., automatically, determines to stop the activation of the at least one ultrasound transducer. In some embodiments, the console determines to stop the activation of the at least one ultrasound transducer based on the monitored results, e.g., if the monitored at least one activation parameter of the at least one ultrasound transducer is not within a range of desired values. In some embodiments, the console delivers an indication to a user prior to and / or after stopping the activation of the at least one ultrasound transducer. Alternatively or additionally, the console delivers an indication to a remote device prior to and / or after stopping the activation of the at least one ultrasound transducer. In some embodiments, the activation of the at least one ultrasound transducer is stopped, e.g., if the number of pulses generated by the at least one ultrasound transducer exceeds a predetermined value.

[0356] According to some example embodiments, after stopping the activation of the at least one ultrasound transducer, the console modifies one or more activation parameters, e.g., current and / or voltage, of other ultrasound transducers of the ultrasound applicator. In some embodiments, the console modifies one or more activation parameters of other ultrasound transducers, e.g., to compensate for the loss of ultrasound energy from the stopped at least one ultrasound applicator.

[0357] According to some example embodiments, the console receives instructions to a user to stop the activation of the at least one ultrasound transducer, e.g., in response to the alert signal sent to a remote device.

[0358] According to some example embodiments, at block 152, optionally, e.g., by a console, the ultrasound applicator is deactivated. In some embodiments, the ultrasound applicator is deactivated based on the monitored results performed at block 146. In some embodiments, the ultrasound applicator is optionally, e.g., automatically, deactivated if activation of two or more transducers of the ultrasound applicator is stopped. In some embodiments, the ultrasound applicator is deactivated if the stopping of the two or more ultrasound transducers affects the safety and / or efficacy of the treatment. In some embodiments, the ultrasound applicator is optionally deactivated at block 152, e.g., if the number of pulses generated by the transducers of the ultrasound applicator exceeds a predetermined value.

[0359] According to some example embodiments, a plurality of instructions to replace the ultrasound applicator is optionally received at block 154. In some embodiments, the plurality of instructions is received at block 144 during the activation. In some embodiments, the plurality of instructions to replace the ultrasound applicator is received from a remote device. Alternatively, the plurality of instructions to replace the ultrasound applicator is optionally generated automatically by the console.

[0360] According to some example embodiments, the activation of the ultrasound applicator is stopped at 146, for example when a treatment session ends. In some embodiments, the activation of the ultrasound applicator is stopped automatically by the console or upon input from a user of the ultrasound system.

[0361] Example ultrasound energy effects

[0362] According to some example embodiments, a plurality of ultrasound waves, for example a plurality of non-focused ultrasound waves, emitted from at least one ultrasound transducer penetrate into a plurality of deep tissue layers. In some embodiments, while a plurality of deep tissue layers are affected by the heat generated by the plurality of ultrasound waves, a plurality of superficial layers, for example layers placed in contact with the applicator or the ultrasound transducers of the applicator, are not thermally affected by the generated heat. Reference is now made to FIG. 2A depicting a differential effect of ultrasound energy on tissue layers of the skin, according to some example embodiments of the present application.

[0363] According to some example embodiments, a plurality of ultrasound waves 208 is emitted into the skin 206. The skin 206 comprises 3 main tissue layers: (1) epidermis, (2) dermis, and (3) subcutaneous tissue. In some embodiments, a plurality of transducers, for example ultrasound transducers 204, emit non-focused ultrasound energy or waves 208 having parameter values, for example frequency values and / or amplitude values, that allow the plurality of ultrasound waves 208 to penetrate into the skin tissue. In some embodiments, the waves 208 that penetrate into the skin deliver non-focused ultrasound energy that heats target tissue regions 210 located at a distance of at least 0.5 mm, for example at least 1 mm, at least 1.5 mm, at least 2 mm, or any intermediate, smaller or larger distance, from the transducers 204. In some embodiments, the emitted ultrasound waves heat a specific tissue volume, for example a large tissue volume in each of the target regions 210.

[0364] According to some example embodiments, while the plurality of ultrasound waves is emitted, a cooling system 202 cools the emitting surface of the plurality of ultrasound transducers 204 proximate to or the epidermis layer contacting the plurality of transducers 204. In some embodiments, the cooling system keeps the outer surface of the transducers in contact with the epidermis cool enough to prevent thermal damage to the epidermis. In some embodiments, the cooling system 202 cools the outer surface of the ultrasound transducers to a temperature in a range of 5°C to 35°C, such as 5°C to 20°C, 10°C to 30°C, 15°C to 35°C, or values in any intermediate, smaller or larger range. Optionally, the temperature of the outer surface of the ultrasound transducers depends on the amplitude, frequency and / or duration of the ultrasound emission. In some embodiments, the cooling system 202 generates a cold flow 212 of cold waves from the cooling system 202 through the outer surface of the ultrasound transducers 204 into the skin tissue 206.

[0365] According to some example embodiments, for example, as described in FIG. 2B the ultrasound energy heats a volume of tissue located at a depth of at least 0.5 mm, such as at least 2 mm, at least 2.5 mm, or values in any intermediate, smaller or larger range, to a temperature level in a range of 50°C to 70°C, such as in a range of 50°C to 60°C, in a range of 55°C to 65°C, 60°C to 70°C, or values in any intermediate, smaller or larger range. In some embodiments, the temperature gradually decreases in tissue layers of the skin deeper than 2.5 mm, such as deeper than 3 mm, deeper than 3.5 mm, or values in any intermediate, smaller or larger range. In some embodiments, by proper selection of parameters of the ultrasound power emitted into the tissue and / or parameters of the cold flow 212, the most heated volume of the tissue can be displaced along the direction of the ultrasound propagation.

[0366] Reference is now made to FIG. 2C and 2D illustrating the heating of large deep tissue volumes according to some example embodiments of the present application.

[0367] According to some example embodiments, for example, as described in FIG. 2C and 2DAs shown, the plurality of ultrasound waves 236 emitted from a surface of an ultrasound transducer, for example, an elongated surface 230 applied to the skin 232, heat an elongated volume of tissue 234. In some embodiments, the elongated volume of tissue has a cylindrical or wavy shape with a longitudinal axis 238 that is nearly parallel to a longitudinal axis 240 of the elongated surface 230 of the ultrasound transducer, for example, at an angle of less than 10 degrees, for example, less than 5 degrees, less than 3 degrees, less than 1 degree, or any intermediate, smaller, or larger angle. In some embodiments, the tissue composition beneath the skin surface and the heated volume of tissue affect the direction of the longitudinal axis 238.

[0368] According to some example embodiments, a length 231 of the elongated cylindrical volume of tissue 234 heated by the plurality of ultrasound waves 236 is equal to or shorter than a length 233 of the elongated surface 230 of the ultrasound transducer from which the plurality of ultrasound waves is emitted by at most 10% or any intermediate, smaller, or larger value. In some embodiments, a length 231 of the elongated cylindrical volume of tissue 234 heated by the plurality of ultrasound waves 236 is shorter than a length 233 of the elongated surface 230 of the ultrasound transducer from which the plurality of ultrasound waves is emitted by 1% to 15%, for example, 1% to 5%, 3% to 10%, 5% to 8%, or any intermediate, smaller, or larger range of values. In some embodiments, the tissue composition beneath the skin surface can also affect the cross-section of the elongated cylindrical volume of tissue 234. Optionally, the cross-section becomes non-uniform along the longitudinal axis 238.

[0369] According to some example embodiments, an array of ultrasound transducers is configured to generate and emit a plurality of ultrasound waves to heat a plurality of spaced apart elongated volumes of tissue. Optionally, the plurality of heated elongated volumes of tissue are located on a plane at a depth of at least 3 mm from a surface of a skin that contacts the ultrasound applicator. In some embodiments, the plane of the plurality of heated elongated volumes of tissue is substantially parallel to the array of transducers.

[0370] According to some example embodiments, for example, as FIG. 2DAs shown, the heated volume of tissue is an elongated core of the elongated volume of tissue. In some embodiments, the temperature level of the elongated core 242 of the elongated volume of tissue 234 is higher than a temperature level of a plurality of tissue layers within the elongated volume of tissue 234 surrounding the elongated core 242. In some embodiments, the temperature of the elongated core 242 of the elongated volume of tissue 234 is in a range of 50°C to 70°C, such as in a range of 50°C to 60°C, in a range of 55°C to 65°C, in a range of 60°C to 70°C, or any intermediate, smaller or larger range of values. In some embodiments, the temperature of the elongated core 242 of the elongated volume of tissue 234 is at least 50°C, such as at least 55°C, at least 65°C, or any intermediate, smaller or larger value. In some embodiments, the cylindrical volume of tissue heated by the plurality of ultrasound waves is located in the dermis tissue layer.

[0371] According to some example embodiments, a shape and / or size of the elongated volume of tissue is based on an amplitude, frequency of the plurality of ultrasound waves, a distance of the ultrasound transducer from the skin surface, and / or a content, tissue type and tissue composition of the plurality of tissue layers between the skin surface and the heated volume of tissue. In some embodiments, the dependence of the shape of the affected volume of tissue on ultrasound transducer operating parameters and tissue composition can optionally be represented, in addition to the cylindrical shape of the heated volume of tissue, that there can be an oval, trapezoidal and other types of shapes. In some embodiments, the shapes can optionally be oval, trapezoidal and other types of shapes. In some embodiments, the heated tissue shapes can optionally change their profile along the ultrasound applicator and at the depth of the tissue.

[0372] Reference is now made to FIG. 2E to 2H which depicts shapes of different ultrasound transducers and examples of heated volumes of tissue produced by the different transducer shapes, according to some example embodiments of the application.

[0373] FIG. 2E A front view and a side view of a rectangular piezoelectric ultrasound transducer (PZT element) 244, similar to the ultrasound transducers described above and according to some example embodiments of the application, are shown. Reference numeral 246 illustrates an elongated cylindrical volume of tissue heated by ultrasound transducer 244, and reference numeral 246-1 is a three-dimensional illustration of an elongated cylindrical volume of tissue heated by ultrasound transducer 244.

[0374] According to some example embodiments, for example, as FIG. 2EAs shown, the ultrasound transducer includes a rectangular PZT element. In some embodiments, the rectangular PZT element heats an elongated cylindrical tissue volume 246 and 246-1 having multiple open ends, such as end 247. A potential advantage of having one or two open ends can be to allow cells and / or biological material to penetrate into the heated cylindrical tissue, for example, to allow for faster regeneration.

[0375] FIG. 2F A front and side view of a stretched hexagonal ultrasound transducer 248 is shown in accordance with some example embodiments of the present application. Reference numerals 250 and 250-1 refer to an elongated cylindrical tissue volume 250 heated by a stretched hexagonal ultrasound transducer, and 250-1 is a three-dimensional view of an elongated cylindrical tissue volume heated by stretched hexagonal ultrasound transducer 244.

[0376] According to some example embodiments, for example, as FIG. 2F As shown, the ultrasound transducer, such as a PZT element of the ultrasound transducer, has a top view of a hexagon that is shaped and sized to face a lower planar surface of skin tissue. In some embodiments, the hexagonal ultrasound transducer heats an elongated cylindrical tissue volume that has a width 249 that is greater than a height 251 of the heated cylindrical tissue volume. A potential advantage of a hexagonal ultrasound transducer can be to treat larger areas of deep tissue layers with lower ultrasound energy penetration.

[0377] FIG. 2G A front and side view of a stretched hexagonal ultrasound transducer 252 placed in contact with a skin surface 232 is shown in accordance with some example embodiments of the present application. Reference numerals 251 and 253-1 refer to an elongated tissue volume 251 heated by a stretched hexagonal ultrasound transducer, and 253-1 is a three-dimensional view of an elongated tissue volume heated by stretched hexagonal ultrasound transducer 252.

[0378] According to some example embodiments, for example, as FIG. 2G As shown, the ultrasound transducer, such as a PZT element of the ultrasound transducer, has a top view of a polygon, such as a decagon, that has multiple sides. In some embodiments, the polygonal ultrasound transducer heats a tissue volume having multiple variable widths. Optionally, the tissue volume heated by the polygonal ultrasound transducer has narrow or closed front and back end openings.

[0379] FIG. 2HA front and side view of a contoured ultrasound transducer 254 is shown in accordance with some example embodiments of the present application. Reference numerals 256 and 256-1 denote by analogy an elongated tissue volume 256 heated by a contoured hexagonal ultrasound transducer, and 256-1 is a three-dimensional view of a contoured tissue volume heated by a contoured ultrasound transducer 254.

[0380] An ultrasound transducer with a skin-facing surface that has an irregular shape or an irregular projection, e.g., a polygon as shown, can have a potential advantage of creating a less artificial pattern on the skin, and thus less noticeable compared to a rectangular shape, as shown. FIG. 2F to 2H FIG. 2E

[0381] FIG. 2I An example of a thermal effect in deep tissue layers of the skin by an array of ultrasound transducers in accordance with some example embodiments of the present application. In some embodiments, an ultrasound applicator, e.g., applicator 204 shown, has an array of ultrasound transducers placed in contact with skin 232. In some embodiments, the contact area of the ultrasound transducers 235 with the skin is up to 30 mm X 10 mm, e.g., up to 20 mm X 10 mm, up to 15 mm X 10 mm, up to 10 mm X 10 mm, or any intermediate, smaller or larger surface area sufficient to fit curved or non-planar areas of a treated subject's skin. In some embodiments, curved areas of the skin include areas around the forehead and / or the neck. In some examples, the ultrasound transducers, e.g., transducers 235, emit non-converging ultrasound energy into the skin 232. In some embodiments, the ultrasound energy penetrates deep tissue layers of the skin and heats elongated tissue volumes 234 in the deep tissue layers. FIG. 2A

[0382] According to some example embodiments, the cross-sections of the heated tissue volumes are similar to the cross-sections of the heated skin volumes 234 described above, despite the different geometries of the ultrasound transducers shown. FIG. 2F to 2H

[0383] According to some example embodiments, an array of ultrasound transducers includes at least two spaced-apart ultrasound transducers, e.g., transducers 235 and 235-1 shown. FIG. 16C 16D ​​​​​The plurality of transducers 1150 are shown. In some embodiments, the plurality of ultrasound transducers are positioned at a distance of at least 0.5 mm, at least 0.7 mm, at least 1 mm, at least 5 mm, at least 10 mm, at least 20 mm, or any intermediate, smaller or larger value, from each other. In some embodiments, the maximum distance between two adjacent transducers of the same ultrasound applicator is in a range of 0.5 mm to 20 mm, for example 0.5 mm to 5 mm, 2 mm to 10 mm, 5 mm to 15 mm, or values in any intermediate, smaller or larger range. In some embodiments, the distance between adjacent transducers is modified by the user of the ultrasound system, for example according to the type, anatomy and / or tissue composition of the treatment region. Optionally, the user selects an ultrasound applicator having a desired distance between the ultrasound transducers according to at least one of a planned treatment protocol, the type, anatomy and tissue composition of the treatment region.

[0384] According to some example embodiments, a user of the ultrasound system selects an ultrasound applicator, for example having a desired number of ultrasound transducers, having a desired shape, having a desired distance between them and arranged in a desired shape, according to at least one of the size, location and shape of the skin region to be treated, and / or according to the size and shape of the heated region inside the skin.

[0385] According to some example embodiments, a distance or spacing between two adjacent ultrasound transducers in the array is fixed. Alternatively, the distance or spacing between some adjacent ultrasound transducers varies. In some embodiments, a console of the system can be connected to different ultrasound applicators having different distances between adjacent transducers. In some embodiments, the ultrasound energy or waves emitted from the plurality of spaced-apart ultrasound transducers heat spaced-apart elongated tissue volumes in the deep tissue layers of the skin, for example FIG. 2I The plurality of tissue volumes 234 are shown. In some embodiments, the distance or spacing between adjacent ultrasound transducers determines a distance or spacing between adjacent heated elongated tissue volumes 234. In some embodiments, the tissue in the deep tissue layers located between adjacent heated elongated tissue volumes, for example tissue 258, is not affected or minimally affected by the energy emitted by the plurality of ultrasound transducers 235.

[0386] According to some example embodiments, the distance or spacing between the plurality of ultrasound transducers determines the fractional heating of the plurality of deep tissue layers and is related to the deep heating skin effects, such as skin tightening. Additionally, the effect on the skin is determined based on the size and / or shape of the plurality of unaffected tissue volumes 258 located between the plurality of heated tissue volumes 234.

[0387] According to some example embodiments, at least some or each parameter of the fractional heating pattern, such as the plurality of heated tissue volumes separated by less affected tissue volumes in the plurality of deep tissue layers of the skin, affects the healing process of the plurality of heated tissue volumes. In some embodiments, the at least one parameter includes the overall size of the treatment area, such as the fractional area distance between the plurality of heated tissue volumes, the plurality of cell types between the plurality of heated tissue volumes, the size and / or shape of the plurality of heated tissue volumes, the amount of damage to the cells in the plurality of heated tissue volumes.

[0388] According to some example embodiments, at least one parameter of the plurality of emitted ultrasound waves, such as amplitude, frequency and / or duration determines at least one of the size and / or shape of the plurality of heated tissue volumes, and the distance or spacing between adjacent heated tissue volumes in the fractional heating pattern.

[0389] According to some example embodiments, a tissue volume, such as an elongated tissue volume heated in the plurality of deep tissue layers has a volume in the range of 1 cm 3 to 20 cm 3 , such as 1 cm 3 to 10 cm 3 , 5 cm 3 to 15 cm 3 , 10 cm 3 to 20 cm 3 , or any intermediate, smaller or larger range.

[0390] According to some example embodiments, the applied ultrasound power and / or the volume of the heated elongated skin volume under the skin 232 can be such that it will leave an indentation or even a lesion 260 on the surface of the skin 232.

[0391] According to some example embodiments, the plurality of elongated tissue volumes are heated to a temperature in the range of 30 to 75 °C, such as 30 to 50 °C, 45 to 60 °C, 55 to 75 °C, or any intermediate, smaller or larger range of temperatures.

[0392] According to some example embodiments, a transmitting surface of a planar array of transducers has an area size in a range of 10 mm 2 to 200 mm 2 , for example 10 mm 2 to 50 mm 2 , 40 mm 2 to 100 mm 2 , 10 mm 2 to 100 mm 2 , 100 mm 2 to 200 mm 2 or any intermediate, smaller or larger range of surface areas.

[0393] According to some example embodiments, for example as shown in FIG. 2I , a minimum distance between heated tissue volumes, for example between two adjacent cores 242 of the tissue volumes 234, is in a range of 0.5 to 10 mm, for example 0.5 to 5 mm, 3 to 8 mm, 4 to 10 mm or any intermediate, smaller or larger range of distances.

[0394] Example system

[0395] Reference is now made to FIG. 3A , which depicts a system for delivering skin treatments using ultrasound, for example cosmetic skin treatments, according to some example embodiments of the present application.

[0396] According to some example embodiments, a system for delivering skin treatments using ultrasound, for example system 300, includes a console, for example console 302, an ultrasound applicator, for example applicator 304, and an umbilical connection channel, for example channel 303, connecting the applicator 304 to the console. In some embodiments, the channel 303 is part of the applicator 304. In some embodiments, the applicator 304 is irreversibly assembled with channel 303, for example to prevent a user from separating the applicator 304 from the channel 303.

[0397] According to some example embodiments, the ultrasound applicator 304 is reusable, for example can be optionally used for a period of at least 1 week, at least 2 weeks, at least 1 month or any intermediate, shorter or longer period of time. In some embodiments, the ultrasound applicator 304 is optionally used for treating at least two subjects.

[0398] According to some example embodiments, the applicator 304 comprises at least one ultrasound transducer. In some embodiments, the applicator 304 comprises two or more ultrasound transducers, for example 2, 4, 6, 8, 10, 12, 14, 18, 20 or any smaller or larger number of ultrasound transducers, for example a plurality of transducers 308. In some embodiments, the plurality of transducers 308 is arranged in an array of ultrasound transducers. In some embodiments, a distance between adjacent transducers in the array is in a range of 0.1 mm to 10 mm, for example 0.1 mm to 3 mm, 2 mm to 4 mm, 2 mm to 5 mm, 4 mm to 7 mm, 5 mm to 10 mm or any intermediate, smaller or larger range of values. In some embodiments, a distance between adjacent transducers is fixed, for example to produce a uniform effect on the tissue by all transducers. Alternatively, a distance between at least some adjacent transducers of the array varies, for example to produce a differential effect on a region of tissue having a non-uniform structure, shape and / or tissue composition.

[0399] According to some example embodiments, each of the plurality of transducers and / or the array of transducers is shaped as a rectangle or a square. In some embodiments, an ultrasound energy emitting area of the applicator 304 is positioned to face the skin, having an area size in a range of 1 mm 2 to 10 mm 2 , for example 2 mm 2 to 6 mm 2 , 3 mm 2 to 5 mm 2 or any intermediate, smaller or larger area size or range of values.

[0400] According to some example embodiments, an ultrasound energy emitting surface of the plurality of transducers is positioned in proximity to a surface of the applicator, the applicator being shaped and dimensioned to contact the skin. In some embodiments, the skin-contacting surface of the applicator is curved. Alternatively or additionally, the skin-contacting surface of the applicator is flat, for example without protrusions or protrusions emanating from the surface towards the skin.

[0401] According to some example embodiments, the skin contact surface is part of the applicator housing. In some embodiments, the applicator housing includes a window in the skin contact surface of the applicator. In some embodiments, the plurality of transducers 308 is at least partially disposed within the window and oriented such that the ultrasound energy emitting surfaces of the plurality of transducers are within the window and oriented outwardly. In some embodiments, the window is covered by at least one insulating layer, e.g., insulating layer 308, configured to close the window and insulate the plurality of ultrasound transducers from the skin.

[0402] According to some example embodiments, the at least one insulating layer is thin enough to allow the plurality of ultrasound waves from the plurality of ultrasound transducers 308 to enter the skin. In some embodiments, a thickness of the at least one insulating layer is in a range of 10 to 50 pm, e.g., 12.5 pm to 25 pm, 10 pm to 20 pm, 15 pm to 35 pm, 30 pm to 50 pm, or a plurality of values within any intermediate, smaller, or larger range. In some embodiments, the at least one insulating layer 306 is configured to insulate the plurality of transducers 308 and / or internal components of the applicator from water and air. In some embodiments, the at least one insulating layer includes polyimide and / or glue and / or parylene and / or latex.

[0403] According to some example embodiments, the plurality of transducers is coupled to at least one transducer holder, e.g., holder 310. In some embodiments, a back surface of the plurality of transducers, e.g., a surface opposite the ultrasound emitting surfaces of the plurality of transducers, is coupled to the holder 310. In some embodiments, the holder 310 includes a plurality of mounting surfaces shaped and sized to be in contact with the plurality of transducers. In some embodiments, a dimension, e.g., a width and / or a length, of each mounting surface is at least 0.5% larger, e.g., at least 1%, at least 5%, at least 10%, or any intermediate, smaller, or larger percentage, than a dimension, e.g., a width and / or a length, of a transducer configured to be mounted to the mounting surface.

[0404] According to some example embodiments, the holder 310 comprises a thermally conductive material, such as aluminum or copper, or stainless steel or any other thermally conductive material, for example, to conduct heat from the plurality of ultrasound transducers to a cooler, such as a thermoelectric cooler (TEC) 312. In some embodiments, a surface of the holder 310 is placed in contact with a cold surface of the TEC 312, for example, to allow the TEC 312 to cool the plurality of transducers 308 through the cold surface. In some embodiments, a hot surface of the TEC 312 is placed in contact with a liquid cooling system of the system, which circulates a cooling liquid between the console 302 and the applicator 304 through the umbilical connection channel 303. Optionally, the hot surface contact comprises a cooling chamber 314 in the applicator 304 that contains the circulating cooling liquid.

[0405] According to some example embodiments, an amplifier comprises the plurality of transducers 308 assembled to the holder 310, and the TEC 312 in contact with the holder. In some embodiments, the applicator 304 comprises a main printed circuit board (PCB) 327. In some embodiments, the main PCB 327 comprises a flexible portion and a rigid board comprising at least one electrical connector. In some embodiments, the flexible portion is electrically connected to the plurality of transducers 308, for example, to deliver electrical power from the rigid board to the plurality of transducers. Optionally, the flexible portion connected to the plurality of transducers 308 is not passivated. In some embodiments, the rigid board of the main flexible PCB is electrically connected to a power source in the console 302, for example, through at least one electrical connector.

[0406] According to some example embodiments, the applicator 304 comprises at least one thermal sensor, such as a thermistor configured to measure a temperature of the skin and / or a temperature of at least one transducer. In some embodiments, at least one thermal sensor comprises at least one surface thermal sensor positioned near a surface where the ultrasound applicator contacts the skin. In some embodiments, at least one surface thermal sensor is configured to sense and transmit a plurality of temperature levels of the skin in contact with the applicator. In some embodiments, at least one surface thermal sensor comprises a thermistor.

[0407] According to some example embodiments, the applicator comprises two or more thermal sensors 328, for example a plurality of thermistors. In some embodiments, at least one thermistor is configured to record, for example sense and transmit, a plurality of temperature levels of the skin, and at least one other thermistor is configured to record the temperature of at least one transducer and / or the temperature of the holder 310. In some embodiments, the plurality of thermal sensors is part of a plurality of thermistor flex PCBs configured to bend and contact the plurality of transducers 308 and / or the holder 310. Optionally, the plurality of thermal sensors 328, for example the plurality of thermal sensors of the plurality of thermistor flex PCBs, are shaped and sized to be positioned between the plurality of transducers 308 on the holder 310, for example to record the temperature of the skin when the applicator is in contact with the skin surface. In some embodiments, the plurality of thermistor flex PCBs are electrically connected to at least one electrical connector of the main flex PCB of the applicator.

[0408] According to some example embodiments, the applicator 304 comprises at least one contact sensor, for example contact sensor 325, configured to record signals indicative of the contact of the applicator 304 with the skin. In some embodiments, the contact sensor 325 records changes in impedance and / or conductivity resulting from the contact with the skin.

[0409] According to some example embodiments, the applicator 304 is mechanically connected to the console 302 by an umbilical connection channel, for example connection channel 303. In some embodiments, the channel 303 is connected to the console 302, for example to an umbilical connection channel socket in the console enclosure 319. In some embodiments, the connection channel socket comprises at least one electrical connector configured to connect the electrical wiring of the connection channel to the console 302. Additionally, the connection channel socket comprises at least one cooling system connector configured to connect the tubing in the connection channel 303 and the applicator 304 to tubing in the console 302 leading to the cooling system 318.

[0410] According to some example embodiments, the channel 303 is a flex channel formed as a tube with an internal lumen. In some embodiments, the connection channel includes electrical wiring of the applicator 304 and cooling system tubes. In some embodiments, the cooling system tubes are insulated from the electrical wiring. In some embodiments, at least part of the connection channel 303 is sealed from air and water, for example, to prevent condensation of water on the cooling system tubes due to penetration of moist air into the connection channel. In some embodiments, the electrical wiring is electrically isolated from the cooling system by a sealing fluid, for example, a solidified sealing fluid. In some embodiments, the solidified sealing fluid is configured to cover the electrical wiring within the applicator body while the sealing fluid is in a liquid state and to solidify within the applicator body.

[0411] According to some example embodiments, the console 302 includes a cooling system 318, for example, a condenser, positioned at a bottom of an enclosure of the console 302, for example, to lower a center of gravity of the console. In some embodiments, the condenser includes a cooling liquid reservoir and an electric pump configured to circulate the liquid coolant between the reservoir and the applicator.

[0412] According to some example embodiments, the console includes at least one radio frequency (RF) signal generator 322 configured to generate and deliver an electrical power signal to the transducers 308 through electrical wiring between the console 302 and the main flex PCB 327 of the applicator 304. In some embodiments, the console 302 includes a control circuit 320 configured to control the RF signal generated by the RF signal generator and to deliver the signal to the transducers 308.

[0413] According to some example embodiments, the control circuit 320 is electrically connected to at least one thermal sensor of the applicator, for example, sensors 328. In some embodiments, the control circuit 320 controls the activation of the cooling system 318 and / or the activation of the RF signal generator 322 based on signals received from the thermal sensors 328 and / or the at least one contact sensor 325 of the applicator 304.

[0414] According to some example embodiments, the console 302 comprises a user interface, e.g. user interface 330, configured to receive input from an operator of the system and / or deliver at least one human detectable indication to the operator of the system. In some embodiments, the user interface 330 comprises a display for presenting visual indications to the operator. In some embodiments, the display is a touch display configured to receive input from the operator. Alternatively or additionally, the user interface comprises a keyboard and / or at least one button for receiving input from the operator.

[0415] According to some example embodiments, the console 302, e.g. the RF signal generator 322 and / or the control circuitry 320 of the console 302, is connected to an external power source 334.

[0416] According to some example embodiments, the console 302 comprises a memory 332 electrically connected to the control circuitry 320. In some embodiments, the memory 332 stores at least one treatment protocol or parameters thereof, e.g. amplitudes and / or frequencies of the ultrasound waves, a desired amount of total ultrasound energy per selected treatment area, a duration of a single pulse of the ultrasound waves, a number of pulses in a sequence of pulses, a number of sequences of pulses per treatment session. In some embodiments, the memory stores a treatment history of a specific subject, e.g. in a database comprising information of a plurality of specific subjects. In some embodiments, the memory 332 stores a plurality of safety parameter values, e.g. maximum allowed temperature levels of the skin, maximum allowed temperature levels of the holder, maximum allowed intensity, frequency and duration of energy delivery to the tissue.

[0417] According to some example embodiments, if the temperature of the skin and / or the transducers 308 is higher than a predetermined value, the control circuitry 320 sends a signal to the cooling system to increase the cooling of the transducers and / or skin. Alternatively or additionally, the control circuitry 320 sends a signal to the RF signal generator to stop generating an RF power signal. Alternatively or additionally, the control circuitry 320 generates a human detectable indication, e.g. an alarm signal via the user interface 330, e.g. to provide an alert to an operator regarding the temperature rise.

[0418] According to some example embodiments, the housing 319 of the console 302 is shaped as a tower, positioned on a surface, e.g. a floor. In some embodiments, a projection of the housing 319 on the floor has a small footprint, e.g. less than 2 m 2 ​2 less than 0.6 m 2 or any intermediate, smaller or larger value.

[0419] According to some example embodiments, the console 302 includes two or more wheels coupled to a surface of the console facing the floor. In some embodiments, the two or more wheels are configured to roll on the floor and move the console to a desired location. In some embodiments, the console 302 includes at least one brake, for example a manual brake and / or a leg brake, configured to stop the rolling of the wheels on the floor. In some embodiments, the console 302 includes at least one handle having one or more gripping members shaped and sized to be held by a hand of a human subject and configured to allow the console 302 to be moved to a desired location on the floor.

[0420] According to some example embodiments, the console 302 includes at least one applicator holder coupled to the console housing 319 and shaped and sized to hold the applicator 304 when not in use. In some embodiments, the applicator holder includes a ring or a funnel shaped and sized to surround the body of the applicator 304.

[0421] Reference is now made to FIG. 3B depicting an additional example of a system for delivering ultrasound waves for skin treatment according to some example embodiments of the present application.

[0422] According to some example embodiments, a system for delivering ultrasound waves for skin treatment, for example system 350, includes a system console 352 and an applicator 354 including ultrasound transducers. In some embodiments, the applicator 354 is connected to the console 352 by electrical wiring. Additionally, the applicator 354 is connected to the console 352 by at least one tube of a cooling system shaped and sized to circulate cooling fluid between the system console 352 and the applicator 354.

[0423] According to some example embodiments, the applicator includes a handle having at least one gripping member shaped and sized to be held by a single hand of an operator of the system 350, for example operator 356. In some embodiments, the operator 356 brings the applicator 354 into contact with at least one skin region of a subject, for example patient 358. In some embodiments, the at least one skin region includes one or more of a face, a neck and submental skin region.

[0424] According to some example embodiments, the system console 350 includes at least one user interface configured to receive output and / or deliver input to the system console 352. In some embodiments, the user interface includes a display 364 configured to deliver a visual indication to the operator 356. Optionally, the display 364 includes a touch interface configured to receive input from the operator 356. In some embodiments, the user interface includes a foot pedal 362 configured to receive input from the operator 356, for example when the foot pedal 362 is pressed by the operator's leg. Alternatively or additionally, the applicator includes a user interface, for example for transmitting activation and / or deactivation input signals to the system 350.

[0425] According to some example embodiments, the operator 356 activates the system 350 using a user interface of the console 352 or a user interface of the applicator 354 to deliver ultrasound waves to the skin of the patient 358. In some embodiments, the operator 356 activates the system to deliver ultrasound waves after holding and placing the applicator on the skin of the patient 358 by pressing one or more of the foot pedals 362, at least one activation button of the applicator 354, and / or using a user interface of the console 352.

[0426] According to some example embodiments, the console 352 is designed in a tower shape having a smaller footprint relative to a height of the console. In some embodiments, the console is movable on a surface, for example a floor, by at least two wheels 368 coupled to a surface of the console 352 facing the floor. In some embodiments, the console 352 is electrically connected to an external electrical outlet, for example the outlet 366.

[0427] According to some example embodiments, the ultrasound applicator 304 includes at least one ID tag, for example an RFID tag, comprising ID information. In some embodiments, the console 302 includes at least one reader, for example an RFID reader for reading the ID information. Alternatively, the ID information is stored in an electronic circuit of the ultrasound applicator 304. In some embodiments, the ID information comprises information associated with a specific manufacturer of the ultrasound applicator, a number of ultrasound pulses generated by the ultrasound applicator, a manufacturing date, manufacturing information, a type of ultrasound applicator, and / or setup or calibration information of the ultrasound applicator.

[0428] Example skin treatment

[0429] Reference is now made to the following descriptions, examples, and figures, which together describe some example embodiments of the application. FIG. 3C Fig. 1 depicts a skin treatment process, in accordance with some example embodiments of the application.

[0430] According to some example embodiments, at block 370, a plurality of pre-treatment photographs are taken. In some embodiments, at block 370, a plurality of photographs of at least one defined treatment area are taken, for example, a plurality of photographs of a plurality of specific areas of the face or neck. In some embodiments, at block 370, a plurality of photographs are taken to plan a treatment procedure, for example, to determine a number of treatment sessions required to cover the at least one defined treatment area, a duration of each treatment session, and a number of times the plurality of ports of the ultrasound transducer need to be covered to cover the at least one defined treatment area.

[0431] According to some example embodiments, at block 372, an anesthetic agent is applied. In some embodiments, the anesthetic agent is applied by applying an anesthetic cream or an anesthetic lotion on the skin surface of the at least one defined treatment area.

[0432] According to some example embodiments, at block 374, a plurality of markings, for example, a plurality of grid lines, are optionally presented on the skin. In some embodiments, the plurality of grid lines are presented by drawing the plurality of grid lines on the skin, for example, to mark a plurality of boundaries of at least one defined treatment area. Alternatively, the plurality of grid lines are projected on the skin.

[0433] According to some example embodiments, at block 376, an ultrasound gel is applied.

[0434] According to some example embodiments, at block 378, the skin is tightened. In some embodiments, the skin is tightened, for example, to flatten a plurality of wrinkles or a plurality of indentations in the skin.

[0435] According to some example embodiments, at block 380, the skin is in contact with an ultrasound emitting surface of the ultrasound applicator. In some embodiments, a user of the applicator ensures contact of the applicator with the skin by pressing the emitting surface of the ultrasound applicator on the skin. Optionally, the user receives an indication regarding the contact of a plurality of ultrasound transducers of the ultrasound applicator with the skin. Optionally, the indication is received prior to activating at least one ultrasound transducer of the ultrasound applicator.

[0436] According to some example embodiments, the ultrasound applicator is activated at block 382, e.g., at least one ultrasound transducer of the applicator. In some embodiments, the ultrasound transducer is activated upon contact with the skin, and optionally during the skin tightening. In some embodiments, during the activation of the at least one ultrasound transducer, the at least one ultrasound transducer generates ultrasound energy by converting electricity into vibrations. In some embodiments, during the activation, ultrasound energy is delivered to the skin at the determined at least one treatment area. In some embodiments, during the activation, a plurality of pulses of ultrasound energy are delivered to the skin.

[0437] According to some example embodiments, the ultrasound applicator includes 2 or more ultrasound transducers, e.g., 5, 7, or 4 to 8 ultrasound transducers. In some embodiments, the ultrasound applicator is activated even if at least one ultrasound transducer is not functioning properly, e.g., if the at least one ultrasound transducer converts electricity into vibrations and ultrasound energy with less than a predetermined reference or baseline value of efficiency. In some embodiments, the ultrasound applicator is deactivated if at least two adjacent ultrasound transducers are not functioning properly.

[0438] According to some example embodiments, at block 384, the ultrasound applicator is advanced on the skin in increments. In some embodiments, the ultrasound applicator is advanced on the skin while the at least one ultrasound transducer is activated. Alternatively, the at least one ultrasound transducer is activated while the ultrasound applicator is stationary. In some embodiments, the ultrasound applicator is advanced on the skin between the plurality of ultrasound applicator launch surface positions in increments of at least 10% overlap, e.g., at least 30% overlap, at least 40% overlap, at least 50% overlap, or any intermediate, smaller or larger percentage overlap. In some embodiments, the ultrasound applicator is advanced on the skin in increments of about 50% overlap, e.g., to enable proper treatment even if at least one ultrasound transducer is not functioning properly.

[0439] According to some example embodiments, at block 386, the ultrasound applicator is advanced to form a plurality of horizontal and / or vertical openings. In some embodiments, the ultrasound applicator is advanced on the skin to form horizontal then vertical openings. In some embodiments, the ultrasound applicator is advanced on the skin to form at least 2 horizontal openings and at least 2 vertical openings.

[0440] In some embodiments, when treating multiple areas of skin around the forehead and / or eye sockets, the at least one ultrasonic transducer is activated to deliver 20 to 50 ultrasonic energy pulses, such as 20 to 40 pulses, 25 to 40 pulses, 30 to 45 pulses, or any intermediate, smaller, or larger range of pulses. In some embodiments, when treating multiple areas of skin on the left and / or right cheek, chin, and / or upper lip, the at least one ultrasonic transducer is activated to deliver 70 to 120 ultrasonic energy pulses, such as 70 to 90 pulses, 80 to 100 pulses, 90 to 110 pulses, or any intermediate, smaller, or larger range of pulses. In some embodiments, when treating areas of skin on the neck and submental region, the at least one ultrasonic transducer is activated to deliver 50 to 90 ultrasonic energy pulses, such as 50 to 70 pulses, 60 to 80 pulses, 70 to 90 pulses, or any intermediate, smaller, or larger range of pulses.

[0441] Exemplary use of the ultrasonic system

[0442] Now for reference FIG. 4A It describes a process by which an operator uses the system according to some exemplary embodiments of the present invention.

[0443] According to some exemplary embodiments, a console of the system, for example FIG. 3A The console 302 shown FIG. 3B The console 352 shown is positioned near a subject, such as a patient, at a desired location. In some embodiments, the location is selected based on the distance between an applicator connected to the console via the umbilical connection channel and a treatment target within the subject.

[0444] According to some exemplary embodiments, the system is started at block 404. In some embodiments, the system is started using the user interface of the console. In some embodiments, the startup of the system triggers the startup of the cooling system.

[0445] According to some exemplary embodiments, at block 406, a user of the system, such as an operator, selects a protocol, such as a cosmetic treatment protocol. In some embodiments, the protocol is selected based on at least one parameter of the patient, such as skin type and / or skin condition in the treatment area, location of the treatment area, appearance of wrinkles in the treatment area, treatment history of the patient and / or multiple other patients with multiple similar characteristics, and the patient's sensitivity to pain and / or to multiple medications used to reduce pain levels.

[0446] According to some example embodiments, at block 408, at least one treatment parameter value is selected, for example, by an operator. In some embodiments, the at least one parameter includes an amplitude and / or a frequency of the plurality of ultrasound waves. Additionally or alternatively, the at least one parameter includes a duration of delivery of the plurality of ultrasound waves, a total energy delivered to a selected treatment area in a single treatment session.

[0447] According to some example embodiments, at block 410, an indication related to the temperature of the applicator, for example, a temperature of an applicator component, is received. In some embodiments, an operator of the system receives the indication from a user interface of the system, for example, a user interface of the console. In some embodiments, at block 410, an indication related to one or more of a temperature of the plurality of transducers, a temperature of a holder, a temperature of the cooling liquid, a temperature of a cold surface of a TEC is received.

[0448] According to some example embodiments, at block 412, anesthesia, for example, local anesthesia, is administered at a selected treatment area. In some embodiments, local anesthesia is administered locally to the skin at a selected treatment area. In some embodiments, the anesthesia includes one or a combination of Lidocaine and prilocaine and / or NO gas for relaxation.

[0449] According to some example embodiments, at block 414, an operator places the applicator in contact with the skin at the treatment area. In some embodiments, the operator places the applicator in contact with the skin if a temperature of the plurality of transducers and / or a temperature of the cooling liquid is below a predetermined value or within a range of predetermined values of (-15°C) to 20°C, for example, (-10°C) to 5°C or (-10°C) to (-6°C) or any intermediate value or range of values. In some embodiments, the operator places an ultrasound emitting surface of the applicator in contact with the skin.

[0450] According to some example embodiments, at block 416, a subthreshold energy delivery level is established. In some embodiments, a threshold of energy delivery is the level of energy that causes intolerable side effects, for example, pain, to a subject. In some embodiments, once an energy threshold is determined, parameter values of the plurality of ultrasound waves are set to deliver ultrasound energy below the determined threshold, for example, to prevent harm to the particular subject being treated.

[0451] According to some example embodiments, at block 418, a plurality of ultrasound waves are delivered to the skin at a target area. In some embodiments, an operator initiates the delivery of the treatment using the user interface of the console or the user interface of an applicator, e.g., an activation button on the applicator. In some embodiments, the parameter values of the delivered treatment are calculated based on one or more of a selected protocol, selected treatment parameter values, and determined subthreshold energy delivery levels.

[0452] According to some example embodiments, during the delivery of the treatment, at block 420, temperature related indications are received. In some embodiments, the indications are received by an operator of the system through the user interface of the console, e.g., a display of the console, and / or through a user interface of the applicator, e.g., a display or at least one indicator light on the applicator. In some embodiments, the temperature related indications include one or more indications related to a temperature of the skin at the treatment area, indications related to a temperature of the transducers and / or a holder of the transducers, indications related to a temperature of a cold and / or hot surface of a TEC, and indications related to a temperature of a cooling liquid of the cooling system.

[0453] According to some example embodiments, if the temperature indications indicate that a recorded temperature level is within a desired range of values, the operator continues to deliver the treatment. In some embodiments, at block 424, the operator moves the applicator to a different treatment area.

[0454] According to some example embodiments, if the temperature indications indicate that a recorded temperature level is not within a desired or predetermined range of temperature levels, the treatment is stopped at block 422. In some embodiments, the operator manually stops the treatment. Alternatively, the treatment is automatically stopped by the console.

[0455] Example system actions

[0456] Reference is now made to FIG. 4B depicting actions of a system for delivering ultrasound waves for skin treatment according to some example embodiments of the present application.

[0457] According to some example embodiments, at block 440, upon activation by an operator, the system moves to a standby state. In some embodiments, in a standby state, no ultrasound waves are emitted.

[0458] According to some example embodiments, at block 442, the applicator is cooled to a predetermined temperature. In some embodiments, the applicator is cooled when the system is in a standby state. In some embodiments, at least a portion of a surface of the applicator configured to contact the skin is cooled. In some embodiments, the transducers and / or a holder of the transducers are cooled.

[0459] According to some example embodiments, at block 444, the temperature of the applicator is recorded. In some embodiments, at block 444, the temperature of one or more of the transducers, the skin contact surface of the applicator, the transducer holder, and the cooling fluid is recorded. In some embodiments, the temperature is recorded, e.g., sensed and transmitted, by temperature sensors, e.g., thermistors in contact with the transducers and / or the holder of the transducers comprising a thermally conductive material. In some embodiments, the thermistors are located between the transducers and under a skin contact surface of the applicator. In some embodiments, the thermistors are positioned under at least one insulating layer that insulates the transducers and / or thermistors from liquid and / or air. In some embodiments, the at least one insulating layer prevents a direct contact between internal components of the applicator, e.g., thermistors and / or transducers, and the skin.

[0460] According to some example embodiments, at block 446, an indication about the recorded temperature is delivered. In some embodiments, the indication, e.g., a human detectable indication, is delivered by a user interface of the console, e.g., a display of the console, and / or a user interface of the applicator, e.g., at least one LED.

[0461] According to some example embodiments, at block 448, the contact of the applicator and / or transducers with the skin is recorded. In some embodiments, the contact is recorded by at least one sensor, e.g., a pressure sensor or a sensor measuring at least one electrical property of the transducers. In some embodiments, at least one electrical sensor records the electrical impedance and / or conductivity of the transducers or changes in the impedance and / or conductivity. In some embodiments, the contact of the applicator and / or transducers with the skin is detected from changes in electrical power delivered to the transducers.

[0462] According to some example embodiments, at block 450, an indication is generated and delivered regarding the contact between the applicator and / or the plurality of transducers and the skin. In some embodiments, the indication is a human detectable indication, such as a visual and / or audio indication. In some embodiments, the indication is delivered to an operator of the system using the user interface of the console, such as a display of the console, and / or the user interface of the applicator, such as an LED indicator light of the applicator.

[0463] According to some example embodiments, at block 452, a plurality of ultrasound waves is transmitted. In some embodiments, the plurality of ultrasound waves is transmitted by a plurality of ultrasound transducers, such as an array of ultrasound transducers, through the at least one insulating layer separating the plurality of transducers from the skin to the skin. In some embodiments, the plurality of ultrasound waves is transmitted in the form of a continuous pulse or a series of pulses, such as a sequence of pulses.

[0464] According to some example embodiments, the plurality of ultrasound waves is generated and transmitted according to one or more adjusted parameter values based on one or more of a recorded temperature of the skin, a temperature of the plurality of transducers, a skin type, a treatment area location, and / or a skin condition. In some embodiments, according to one or more of a recorded temperature of the skin, a temperature of the plurality of transducers, a skin type, a treatment area location, and / or a skin condition, a value of the at least one parameter of the transmitted plurality of ultrasound waves is varied during the delivery of the plurality of waves.

[0465] According to some example embodiments, at block 454, during the delivery of the plurality of ultrasound waves, the skin surface is being cooled by the applicator. In some embodiments, the skin surface in contact with the applicator is cooled by a cooling system of the applicator, the cooling system configured to cool the plurality of transducers and the skin surface in contact with the plurality of transducers.

[0466] According to some example embodiments, at block 454, a temperature of a skin surface in contact with the applicator is recorded during the delivery of the plurality of ultrasound waves. In some embodiments, the skin surface temperature is recorded by at least one thermistor placed in indirect contact with the skin surface, and the temperature is recorded through at least one insulating layer.

[0467] According to some example embodiments, at block 456, an indication related to the temperature of the skin tissue is delivered to an operator during the delivery of the plurality of ultrasound waves. In some embodiments, the indication is delivered, e.g., a human detectable indication, during the delivery of the plurality of ultrasound waves. In some embodiments, the indication includes a visual indication, e.g., a change in temperature values displayed to an operator, e.g., on a display of the console. In some embodiments, the indication includes a graphical indication, e.g., a graph, showing a change in temperature. Optionally, the graphical indication shows temperature levels or a change in temperature relative to a maximum temperature value.

[0468] According to some example embodiments, at block 458, the system determines whether the recorded temperature, e.g., the recorded temperature of the skin and / or the transducers, is higher than a predetermined value. In some embodiments, the predetermined value is set individually for a specific person, e.g., based on a predetermined threshold. Alternatively, the predetermined value is a value set by the regulatory authorities for safety considerations.

[0469] According to some example embodiments, if the recorded temperature is higher than the predetermined value, at block 460, an alarm signal is generated and delivered to an operator. In some embodiments, the alarm signal includes a visual and / or an audio signal.

[0470] According to some example embodiments, if the recorded temperature is higher than the predetermined value, at block 462, the delivery of the ultrasound waves is stopped. In some embodiments, the system automatically stops the delivery of the ultrasound energy. Alternatively, the delivery of the ultrasound energy is manually stopped by an operator using the user interface of the console and / or a user interface of the applicator. In some embodiments, the ultrasound energy is manually stopped by activating an emergency shut-off switch.

[0471] According to some example embodiments, alternatively, if the recorded temperature is higher than the predetermined value, at block 464, values of at least one parameter of the treatment are automatically modified, e.g., by a control circuit of the system. In some embodiments, at block 464, values of at least one parameter of the transmitted ultrasound waves are automatically modified, e.g., by a control circuit of the system. In some embodiments, the values of at least one parameter of the treatment and / or values of at least one parameter of the transmitted ultrasound waves are modified by a control circuit, e.g., control circuit 320, according to at least one indication stored in a memory 332 shown. FIG. 3A

[0472] ​According to some exemplary embodiments, the processing of the plurality of ultrasound waves and / or the multiple changes in the multiple parameter values ​​are performed using at least one algorithm and / or at least one lookup table stored in the memory 332. In some embodiments, a correlation is calculated between an input regarding the temperature of the skin and / or the plurality of transducers and multiple entries in the lookup table. In some embodiments, the processing parameters of the plurality of ultrasound waves and / or the at least one parameter are changed according to multiple entries in the lookup table.

[0473] According to some exemplary embodiments, if the temperature of the recorded signal is below a predetermined value or within a range of multiple permissible values, the transmission of the multiple ultrasound waves continues.

[0474] Exemplary delivery of multiple ultrasound waves

[0475] According to some exemplary embodiments, the plurality of ultrasound waves are generated and transmitted with selected amplitude and frequency values ​​to allow heating of multiple tissue volumes in multiple deep layers of the skin. Reference now is made to... FIG. 5A to 5C It describes several different modes for delivering the plurality of ultrasound waves according to some exemplary embodiments of the present invention.

[0476] According to some exemplary embodiments, such as FIG. 5A As shown, the system generates, for example, an intensity up to 30 watts / cm². 2 For example, up to 15 watts / cm² 2 Up to 20 watts / cm 2 Up to 25 watts / cm 2 Multiple ultrasound waves of a single amplitude, or any intermediate, smaller, or larger range. In some embodiments, an intensity of the multiple ultrasound waves is selected based on one or more of skin type, skin condition, a subject's sensitivity to pain, and wrinkle density in the skin.

[0477] According to some exemplary embodiments, the system generates a plurality of ultrasonic waves with frequencies ranging from 0.1 MHz to 30 MHz, such as 1 MHz to 20 MHz, 5 MHz to 15 MHz, 9 MHz to 13 MHz, 9 MHz to 22 MHz, 11 MHz to 13 MHz, 18 MHz to 22 MHz, or any intermediate, smaller, or larger range of values.

[0478] According to some exemplary embodiments, such as FIG. 5B As shown, the multiple ultrasound waves pass through a 5 watt / cm² frequency band. 2 Up to 60 watts / cm 2 For example, 10 watts / cm 2 Up to 40 watts / cm 2 15 watts / cm2 Up to 30 watts / cm 2 Or any multiple values ​​within an intermediate, smaller, or larger range. Additionally, in some embodiments, the multiple ultrasound waves are delivered at a frequency within a range of 10 MHz to 13 MHz, for example, 10 MHz to 12 MHz or any multiple values ​​within an intermediate, smaller, or larger range. In some embodiments, the surface of the skin, such as an area of ​​the skin in contact with the applicator and / or the multiple transducers, is cooled before and after the delivery of the pulse. In some embodiments, the single pulse is delivered to the skin tissue for a duration within a range of 0.5 seconds to 15 seconds, for example, 1 second to 10 seconds, 2 seconds to 8 seconds, 3 seconds to 6 seconds, or any multiple values ​​within an intermediate, smaller, or larger range. In some embodiments, the pulse is delivered for a time period of 2 seconds, 3 seconds, 4 seconds, or 5 seconds. In some embodiments, the skin surface is cooled for at least 2 seconds before the delivery of the pulse, for example, at least 4 seconds, at least 8 seconds, or any intermediate, shorter, or longer duration. In some embodiments, the skin surface is cooled after the delivery of the pulse for at least 2 seconds, such as at least 4 seconds, at least 8 seconds, at least 10 seconds, or any intermediate, shorter, or longer time period.

[0479] According to some exemplary embodiments, such as FIG. 5C As shown, the plurality of ultrasound waves are delivered via a sequence of at least two pulses, such as at least four pulses, at least seven pulses, at least ten pulses, at least twenty pulses, or any intermediate, fewer, or more pulse numbers. In some embodiments, each of the plurality of pulses in the sequence has the same intensity, frequency, and delivery time. Alternatively, at least some of the plurality of pulses in the sequence are delivered with an intensity, frequency, and delivery time different from the other plurality of pulses in the sequence. In some embodiments, the duration between two adjacent pulses in the sequence is in the range of 0.5 seconds to 12 seconds, such as 1 second to 5 seconds, 3 seconds to 8 seconds, 5 seconds to 10 seconds, or any intermediate, smaller, or larger values. In some embodiments, the skin is cooled before and after each pulse.

[0480] Exemplary monitoring during processing

[0481] According to some example embodiments, the coupling of the plurality of transducers to the skin is monitored, for example, to provide inherent safety and performance control over each pulse applied to the skin. In some embodiments, data is sampled at a rate of at least 70 samples per second (p / sec), for example, at least 80 p / sec, at least 100 p / sec, at least 120 p / sec, or any intermediate, lesser, or greater number of points per second, for example, to provide accurate feedback to an operator of the system, for example, a physician or any person certified to use the system. In some embodiments, the sampled data is stored in a memory of the console, and / or in a cloud storage or a remote server. In some embodiments, the sampled data is used to generate a database, to improve processing protocols, and / or for the use of machine learning and artificial intelligence algorithms.

[0482] Reference is now made to FIG. 6A and 6B depicting monitoring a temperature of the skin surface as an indicator of proper contact of the plurality of transducers to the skin, according to some example embodiments of the present application.

[0483] According to some example embodiments, the system monitors the temperature of the skin surface, for example, in line with the delivery of the plurality of ultrasound waves and / or prior to the delivery of the plurality of ultrasound waves. In some embodiments, at least one algorithm stored in a memory of the console measures the temperature level based on signals received from a plurality of thermistors located in proximity to the skin surface, for example, up to 1 mm, for example, up to 0.1 mm, up to 0.01 mm, or any intermediate, lesser, or greater distance from the skin surface. In some embodiments, if a measured temperature exceeds a preset value, the system automatically stops the delivery of the plurality of ultrasound waves.

[0484] An underlying advantage of measuring the skin surface temperature during the delivery of ultrasound waves can be to ensure adequate contact with the skin to ensure energy delivery to the tissue.

[0485] According to some example embodiments, for example, as FIG. 6A depicted, a plurality of temperature levels vary over time by up to 7 °C, for example, up to 6 °C, up to 5 °C, or any intermediate, lower, or higher temperature, indicating proper contact of the plurality of transducers to the skin.

[0486] According to some example embodiments, for example, as FIG. 6BAs shown, the multiple temperature levels vary over time at a rate exceeding 1 °C / sec, e.g., 2 °C / sec, 5 °C / sec, or any intermediate, lower, or higher value, indicating that at least some of the multiple transducers have partial or no contact with the skin.

[0487] According to some example embodiments, electrical impedance is monitored, e.g., to verify proper performance of the multiple transducers, to ensure effective energy transmission to the multiple transducers, and to identify real-time performance degradation, which optionally manifests in the efficiency of the electrical energy conversion to mechanical energy of PZT vibrations, which corresponds to the ultrasound energy emission of the transducers. In some embodiments, if the adhesion between the flex PCB and the PZT changes, the electrical impedance measured on the transducers changes.

[0488] According to some example embodiments, forward / reflected electrical power is monitored. In some embodiments, the RF power applied to the multiple ultrasound transducers and / or the emitted ultrasound energy is monitored.

[0489] RF power applied to the multiple US transducers and the emitted ultrasound energy is monitored.

[0490] According to some example embodiments, e.g., as shown in FIG. 6C As shown, the electrical impedance of the multiple transducers changes in a similar manner as the frequency increases, indicating proper performance of the multiple ultrasound transducers.

[0491] According to some example embodiments, e.g., as shown in FIG. 6D As shown, the difference between the changes in impedance of some ultrasound transducers as the frequency increases indicates improper operation of the multiple transducers. In some embodiments, if the activity of some transducers is detected to change, the delivery of the multiple ultrasound is stopped. Additionally, an alert signal is delivered to an operator of the system.

[0492] Example procedure for identifying degradation in ultrasound energy delivery

[0493] According to some example embodiments, ultrasound energy is generated during the activation of the at least one ultrasound transducer of an ultrasound applicator. In some embodiments, the generated ultrasound energy is delivered into tissue layers of skin during a skin treatment, such as a cosmetic treatment of the skin. In some embodiments, the generation and delivery of the ultrasound energy from the at least one ultrasound transducer, such as the generation efficiency and / or the delivery efficiency, is monitored. In some embodiments, the generation and / or delivery of the ultrasound energy is monitored to detect a failure of one or more of the ultrasound applicator components, such as a failure of at least one ultrasound transducer. Alternatively or additionally, the ultrasound energy generation and / or delivery is monitored to detect when the ultrasound applicator or system is being used inappropriately, such as according to a manufacturer's user instructions. In some embodiments, the monitoring of ultrasound energy generation includes monitoring the conversion of electricity to ultrasound energy by the at least one ultrasound transducer. Referring now to FIG. 6E FIG. 19 depicts a process for identifying a degradation in ultrasound energy delivery according to some example embodiments of the present application.

[0494] According to some example embodiments, an ultrasound applicator is activated at block 601. In some embodiments, at least one ultrasound transducer of the ultrasound applicator is activated, such as 2, 3, 4, 5, 6, 7, 8, 9, or any greater number of ultrasound applicators. In some embodiments, the at least one ultrasound transducer is activated by a console, such as at least one electrical circuit configured to energize the at least one ultrasound transducer.

[0495] According to some example embodiments, the ultrasound applicator is activated for a plurality of time periods of at least 30 days, such as at least 40 days, 50 days, 60 days, or any intermediate, shorter, or longer plurality of time periods. In some embodiments, during the activation time periods, the applicator generates at least 10,000 pulses of ultrasound energy, where each pulse of ultrasound energy is a duration of 30 seconds of ultrasound energy generation. In some embodiments, during the activation time periods, the ultrasound applicator is used to treat two or more subjects.

[0496] According to some example embodiments, at block 603, a decay in ultrasound energy delivery is identified, e.g., a drop in ultrasound energy delivery. In some embodiments, at block 603, a decay in ultrasound energy generation and / or delivery potential efficiency to a plurality of skin tissues is identified. In some embodiments, the decay in ultrasound energy generation and / or delivery potential efficiency is identified during the activation of the at least one ultrasound transducer of the ultrasound applicator. In some embodiments, the identification of the ultrasound energy delivery is performed at one or more time points or continuously during the activation of the one or more ultrasound transducers.

[0497] According to some example embodiments, at block 603, the decay in ultrasound energy generation and / or delivery, e.g., efficiency of ultrasound energy generation and / or delivery, is identified by monitoring a plurality of impedance values of the at least one ultrasound transducer during the activation of the transducer. In some embodiments, a plurality of impedance values of each ultrasound transducer or a group of ultrasound transducers is measured to identify a plurality of changes in impedance values during the activation of the ultrasound applicator, e.g., relative to a reference value indicated in a memory of the system. In some embodiments, a plurality of changes in impedance values of an ultrasound transducer indicates that the ultrasound transducer is not in contact with a skin and / or the active failure of the ultrasound transducer. In some embodiments, a plurality of impedance values is measured based on changes in electrical signals transmitted by a circuit energizing the ultrasound transducer and changes in electrical signals received by the circuit from the ultrasound transducer.

[0498] Additionally or alternatively, at block 601, during the activation of the ultrasound applicator, e.g., during the activation of the at least one ultrasound transducer of the applicator, the decay in ultrasound energy delivery, e.g., efficiency of ultrasound energy delivery, is optionally identified at block 603 based on signals received from one or more temperature sensors. In some embodiments, the one or more temperature sensors sense temperature levels or changes thereof inside the ultrasound applicator and / or in proximity to the ultrasound transducers. In some embodiments, an increase in temperature levels during the activation of the ultrasound applicator, e.g., due to an increase in heat, optionally indicates that one or more of the ultrasound transducers are not in contact with the skin. In some embodiments, the temperature levels or changes thereof are sensed by one or more temperature sensors, e.g., thermistors of the ultrasound applicator located in proximity to the ultrasound transducers and / or in proximity to an emitting surface of the ultrasound applicator that contacts the skin.

[0499] According to some example embodiments, an indication is generated and delivered at block 605. In some embodiments, the indication is generated and delivered if a degradation in the ultrasound energy delivery, such as a degradation in the ultrasound energy delivery efficiency, is greater than 10% or a reference or baseline value. In some embodiments, the indication is a human detectable indication, such as an audio and / or a visual indication delivered to a user of the ultrasound system. In some embodiments, an indication delivered to the user includes instructions to continue the activation of the ultrasound or to replace the ultrasound applicator.

[0500] Alternatively or additionally, the indication includes at least one signal transmitted to a remote device, such as a remote computer, a remote server, a remote cloud storage or any other device not in the same room as the ultrasound system. In some embodiments, the at least one transmitted signal includes at least one log file of the system activity.

[0501] According to some example embodiments, an activity of the ultrasound applicator, such as an activity of at least one ultrasound transducer, is modified at block 607. In some embodiments, if a degradation in the ultrasound energy delivery is identified, the activity of at least one ultrasound transducer, such as the at least one ultrasound transducer in which the undesired impedance values were measured, is stopped. Optionally, the activity of the at least one ultrasound transducer is stopped while the activation of other ultrasound transducers of the ultrasound applicator is continued. In some embodiments, when the activation of at least one ultrasound transducer is stopped, the activation duration and / or activation power, such as voltage and / or current, is increased in the other ultrasound transducers that remain active.

[0502] According to some example embodiments, if a degradation in the ultrasound energy delivery is identified, the activity of the ultrasound applicator, such as the activity of all ultrasound transducers of the ultrasound applicator, is disabled. In some embodiments, the activity modification of at least one ultrasound transducer and / or the disabling of the activity of the ultrasound applicator is performed remotely, such as using signals from the remote device. In some embodiments, if a degradation in the ultrasound energy delivery is identified at block 603, a user of the ultrasound system receives instructions to change a position and / or a direction of the ultrasound applicator relative to the skin.

[0503] Reference is now made to FIG. 6F which depicts a process for measuring impedance of one or more ultrasound transducers and detecting changes in impedance values, according to some example embodiments of the present application.

[0504] According to some example embodiments, a plurality of impedance reference values of two or more ultrasound transducers is determined at block 610. In some embodiments, the two or more ultrasound transducers are separately activated. In some embodiments, the plurality of impedance values of each ultrasound transducer is measured at a plurality of frequencies within a selected range, for example at frequencies within 5 to 20 MHz, 9 to 13 MHz, 5 to 10 MHz, 10 to 20 MHz, or any intermediate, smaller or larger range. In some embodiments, the plurality of measured impedance values are stored as reference impedance values for each of the two or more transducers of the ultrasound applicator.

[0505] In some embodiments, the plurality of impedance measurements performed at block 610 are performed as part of a calibration procedure for each ultrasound transducer or as part of a calibration procedure for the ultrasound applicator. In some embodiments, the calibration procedure is performed prior to a treatment procedure of a patient. Alternatively, the calibration procedure is performed as part of the manufacturing of the ultrasound applicator and / or system.

[0506] According to some example embodiments, the two or more ultrasound transducers are activated at block 612 as part of a treatment procedure. In some embodiments, the two or more ultrasound transducers are activated using a plurality of selected activation parameter values to generate one or more specific heating regions in the skin. In some embodiments, the two or more ultrasound transducers are activated to generate ultrasound waves having similar parameter values, for example similar values of amplitude and / or frequency. Alternatively, the two or more ultrasound transducers are activated to generate ultrasound waves having different parameter values, for example ultrasound waves having different values of amplitude and / or frequency. In some embodiments, the activation parameters of the ultrasound transducers include activation duration, frequency, acoustic intensity, pre-cooling, post-cooling, and driving voltage.

[0507] According to some example embodiments, each of the ultrasound transducers is activated at a range of frequencies, the range of frequencies including the range of frequencies used during a calibration procedure performed at block 610.

[0508] According to some example embodiments, each of the ultrasound transducers or at least some of the ultrasound transducers are activated separately from the rest of the ultrasound transducers. In some embodiments, each of the ultrasound transducers is connected to a different circuit configured to deliver power to the ultrasound transducer. Alternatively, at least some of the ultrasound transducers are connected to the same circuit.

[0509] According to some example embodiments, a plurality of impedance values of the plurality of ultrasound transducers is measured at block 614. In some embodiments, the plurality of impedance values is measured before, during or after the delivery of an ultrasound energy pulse. In some embodiments, the plurality of impedance values of each of the plurality of ultrasound transducers is measured separately. Alternatively, an impedance value of two or more of the plurality of transducers is measured. In some embodiments, an average or mean impedance value of two or more of the plurality of transducers, for example all of the plurality of activated transducers, is measured. In some embodiments, at block 610, the plurality of impedance values is measured for a range of frequencies including in the frequency range used for the calibration procedure.

[0510] According to some example embodiments, the plurality of impedance values is measured by a control circuit of the ultrasound system. In some embodiments, the plurality of impedance values of each transducer is measured by the circuit connected to the ultrasound transducer. In some embodiments, the circuit is connected to the control circuit. In some embodiments, the circuit of each ultrasound transducer is electrically isolated from the rest of the plurality of circuits and / or other ultrasound transducers. In some embodiments, the circuit is connected to an ultrasound card or part of an ultrasound card, for example in a console of the system.

[0511] According to some example embodiments, a plurality of changes in the plurality of impedance values is detected at block 616. In some embodiments, the plurality of changes is detected by the control circuit of the ultrasound system. In some embodiments, a plurality of changes in the plurality of impedance values is detected compared to the plurality of reference impedance values measured at block 610. In some embodiments, a plurality of changes in the plurality of impedance values along a range of frequency values is detected compared to the plurality of impedance reference values measured at block 610. In some embodiments, a plurality of changes in the plurality of impedance values between different ultrasound transducers is detected. In some embodiments, a plurality of changes between the plurality of impedance values of one or more ultrasound transducers is detected, and an average or mean impedance value is detected.

[0512] According to some example embodiments, the plurality of changes in the plurality of impedance values is detected by determining a relationship between the plurality of impedance values measured at block 616 and the plurality of stored reference impedance values measured at block 610.

[0513] According to some example embodiments, an indication is optionally delivered at block 618. In some embodiments, an indication, e.g., a human detectable indication, is delivered to a user of the ultrasound system. In some embodiments, the indication is delivered if the detected changes in impedance values are above a predetermined value. In some embodiments, the indication is delivered if the detected changes are above 1%, e.g., above 5%, above 10%, above 20%, or any intermediate, smaller or larger percentage, of the change between an ultrasound transducer's measured impedance values and other transducers' measured impedance values or an average or mean impedance value. Alternatively or additionally, the indication is delivered if the detected changes are above 1%, e.g., above 5%, above 10%, above 20%, or any intermediate, smaller or larger percentage, of the change between an ultrasound transducer's measured impedance values and stored reference impedance values, e.g., reference values of the same ultrasound transducer.

[0514] According to some example embodiments, at block 620, an activity of at least one ultrasound transducer, e.g., an ultrasound transducer detecting changes in impedance, is modified. In some embodiments, the activity is modified based on the detected changes in impedance at block 616. In some embodiments, modifying an activity of an ultrasound transducer includes modifying current and / or voltage values delivered to the at least one ultrasound transducer. Alternatively or additionally, modifying an activity of an ultrasound transducer includes modifying at least one of a duration of vibration, a frequency of vibration, and an amplitude of vibration of a PZT element of the at least one ultrasound transducer.

[0515] According to some example embodiments, the activity of the at least one ultrasound transducer is modified if the detected changes in impedance values are above a predetermined value. In some embodiments, the activity of the at least one ultrasound transducer is modified if the detected changes are above 1%, e.g., above 5%, above 10%, above 20%, or any intermediate, smaller or larger percentage, of the change between the at least one ultrasound transducer's impedance values and other transducers' impedance values, an average or mean impedance value, or stored reference impedance values.

[0516] According to some example embodiments, modifying an activity of at least one ultrasound transducer includes stopping the activity of the at least one ultrasound transducer. Alternatively, modifying an activity includes modifying an activity of one or more ultrasound transducers to compensate for the undesired activity of one or more ultrasound transducers as indicated by the detected changes in impedance values.

[0517] According to some example embodiments, the activity of at least one ultrasound transducer is selectively modified, for example to produce a predetermined heating volume, optionally having a specific size and / or shape.

[0518] According to some example embodiments, optionally at block 622, instructions are delivered regarding how to change the position and / or orientation of the ultrasound applicator relative to the skin surface. In some embodiments, the instructions are provided in accordance with the changes in the impedance values detected at block 616.

[0519] According to some example embodiments, at block 624, at least one parameter of a skin treatment protocol is optionally modified. In some embodiments, the at least one treatment protocol parameter includes the required duration of activation of at least some of the ultrasound transducers in each specific treatment region in the skin. In some embodiments, at least one treatment protocol parameter includes the number and / or treatment order of skin regions, for example each single treatment session.

[0520] Example ultrasound system for delivering skin treatment

[0521] According to some example embodiments, an ultrasound system for delivering skin treatment is a mobile system, configured to move on a surface, for example a floor, and positioned next to a subject to be treated by the system. In some embodiments, the system is shaped as a tower having a small footprint on the floor. Reference is now made to FIG. 7A to 7C depicting a mobile ultrasound system for delivering skin treatment, according to some example embodiments of the present application.

[0522] According to some example embodiments, a mobile ultrasound system, for example system 702, includes an ultrasound applicator 704 and a console, for example console 706. In some embodiments, the applicator 704 is coupled to the console 706 by an umbilical connection channel 708.

[0523] According to some exemplary embodiments, the connection channel 708 is an elongated connection channel having a length of at least 1 m, such as at least 1.5 m, at least 2 m, or any intermediate, shorter, or longer connection channel 708. In some embodiments, the connection channel is flexible, for example, to allow the applicator to move to multiple different treatment positions of the subject. In some embodiments, the connection channel includes a proximal end near the console 706 and a distal end connected to the applicator 704. In some embodiments, the proximal end of the connection channel 708 includes at least one connector 710, which is shaped and sized to connect to at least one main socket 712 in the console 706.

[0524] According to some exemplary embodiments, the console 706 has a vertical axis 713, a lower end, and an upper end. In some embodiments, the lower end of the console 706 includes a wheel seat 716, the wheel seat 716 including at least two wheels facing a surface, wherein the console 706 is positioned on the surface in an upright direction, for example, when the vertical axis of the console 706 is perpendicular to the floor. In some embodiments, a projection of the console 706 onto the surface on which the console is positioned in an upright direction has a projection of less than 2m. 2 A surface area size, for example, less than 1.5m². 2 Or any intermediate, smaller, or larger surface area.

[0525] According to some exemplary embodiments, an upper end of the console 706 includes a display 714. In some embodiments, the display is tilted within a range of 30 to 60 degrees, for example, 30 to 45 degrees, 40 to 50 degrees, or any of the intermediate, smaller, or larger values, to allow visualization of the display from multiple different angles. In some embodiments, a rear surface of the display is positioned at an angle associated with the console.

[0526] According to some exemplary embodiments, the console 706 includes an applicator retainer 709, for example, to retain the applicator 704 when not in use. In some embodiments, the console includes at least one bottle-shaped retainer 707, which is shaped and sized to hold a bottle, such as a bottle of ultrasonic gel.

[0527] Exemplary Applicator

[0528] Now for reference FIG. 8A to 8C It describes an ultrasonic applicator according to some exemplary embodiments of the present invention.

[0529] According to some example embodiments, an ultrasound applicator, such as applicator 804, includes an applicator body 806 and an umbilical connection channel 808. In some embodiments, the applicator body is coupled to a distal end of the channel 808. In some embodiments, a proximal end of the channel 808 includes at least one console connector configured to connect the applicator 804 to a console of the ultrasound system. In some embodiments, the console connector includes at least one ground connector, such as pin 812, configured to allow grounding of the applicator. In some embodiments, at least one console connector of the channel 808 includes at least one coolant connector configured to connect a cooling system of the applicator 804 to a cooling system of the console, for example, to allow circulation of coolant between the applicator 804 and the console.

[0530] According to some example embodiments, the applicator body 806 includes a handle 815, such as an elongated handle, having at least one gripping member shaped and sized to be held by a single hand of an operator. In some embodiments, the applicator body 806 includes a firing head portion 816 oriented at an angle of between 70 degrees and 180 degrees, such as 70 degrees to 90 degrees, 80 degrees to 100 degrees, 90 degrees to 120 degrees, or values within any intermediate, smaller, or larger range, from the handle 815. A potential advantage of positioning a firing head portion at an angle relative to a handle of the applicator can be to allow easy directing of the firing head portion to a treatment region of a subject, and / or to allow an operator to more easily apply force by resting the applicator body on the treatment region.

[0531] According to some example embodiments, the firing head portion 816 includes transducers 818, such as two or more transducers 818 proximate a surface of the applicator, shaped and sized to be in contact with the skin. In some embodiments, the transducers are linearly organized in an array under and proximate the skin contact surface of the firing head portion 816.

[0532] According to some example embodiments, the handle 815 of the applicator body 806 includes a user interface comprising at least one activation switch, such as switch 820, and / or at least one indicator, such as a visual and / or an audible indicator, configured to produce at least one human-detectable indication to an operator holding the handle 815. In some embodiments, the indicator includes a visual indicator, such as an LED visual indicator 822. In some embodiments, the user interface is oriented on the handle at a distance from the at least one gripping member of the handle selected to allow holding and activation of the user interface with the same hand of an operator. In some embodiments, the user interface is positioned on the handle 815 at a viewing angle of an operator holding the applicator body 806.

[0533] According to some example embodiments, the handle 815 is elongated and optionally at least partially cylindrical, having a width or diameter small enough to be positioned within a palm of an operator’s hand.

[0534] According to some example embodiments, such as shown in FIG. 8C the applicator body 806 is formed by two complementary side panels 820 and 822, a booster cover 817, and an upper panel 824 including a user interface. In some embodiments, electrical wiring 828 and / or coolant fluid tubes 826 pass within an inner cavity of the applicator body housing and into an inner cavity of the umbilical connection channel 808.

[0535] Reference is now made to FIG. 9A and 9B depicting an upper panel of the applicator body housing according to some example embodiments of the present application.

[0536] According to some example embodiments, the upper panel 824 of the housing includes an applicator user interface configured to deliver at least one indication to an operator of the system. Alternatively or additionally, the user interface of the applicator is configured to receive input from the operator, such as an ultrasound delivery activation command for delivering at least one pulse of ultrasound into the skin.

[0537] According to some example embodiments, such as shown in FIG. 9A the applicator user interface includes at least one activation switch, such as activation button 820. In some embodiments, pressing the activation button 820 delivers ultrasound into the skin. In some embodiments, the activation button is waterproof, configured to prevent water or any other liquid from penetrating the applicator body.

[0538] According to some example embodiments, the applicator user interface includes at least one visual indicator, such as LED 822. In some embodiments, the visual indicator delivers a visual, human-detectable indication to an operator, for example, in accordance with a status of the system or in accordance with the status of the activation button 820. In some embodiments, for example, when a user interface of the console, such as the display of the console, is not within a line of sight of an operator, the operator of the system monitors the delivery of the ultrasound waves based on signals received from the at least one visual indicator of the applicator.

[0539] Reference is now made to FIG. 10A to 10D which depicts an arrangement of applicator components, in accordance with some example embodiments of the present application.

[0540] According to some example embodiments, an applicator 1002 includes an applicator body 1004 and an applicator handle 1006. In some embodiments, the handle 1006 is an elongated handle shaped to be positioned within a palm. In some embodiments, the applicator body 1004 and handle 1006 include a single lumen in which energized components, such as wiring of the applicator, are positioned.

[0541] According to some example embodiments, the applicator 1002 includes at least two piezoelectric components (PZTs), such as ceramic PZTs, positioned near a surface of the applicator body shaped and sized to contact the skin. In some embodiments, the PZTs are configured to vibrate and generate ultrasound waves in response to an electric current. In some embodiments, for example, as shown in FIG. 10A and 10C The PZT elements are arranged in an array, such as a linear array, where the PZT elements are arranged along a linear axis of the applicator body.

[0542] According to some example embodiments, at least one thermal sensor 1010, such as at least one thermistor, is positioned near the PZT elements, such as between adjacent PZT elements of the array. In some embodiments, the at least one thermal sensor 1010 is configured to record temperature levels of the skin in temporal relation to the delivery of ultrasound waves, for example, before, during, and / or after the delivery of ultrasound waves.

[0543] According to some example embodiments, for example, as shown in FIG. 10AAs shown, a surface of each of the plurality of PZT elements is placed in contact with a thermoelectric cooler (TEC). In some embodiments, the surface of the PZT element is in contact with a cold surface of the TEC. Alternatively, for example, as shown FIG. 10D As shown, the plurality of PZT elements are arranged on at least one thermally conductive transducer holder, for example holder 1022. In some embodiments, a surface of the holder 1022 is placed in contact with the TEC 1012, for example a cold surface of the TEC 1012. In some embodiments, the at least one thermally conductive holder 1022 is configured to transfer heat from the plurality of PZT elements to a cold surface of a TEC. In some embodiments, the thermally conductive holder comprises or is at least partially made of a thermally conductive material, for example aluminum.

[0544] According to some example embodiments, for example, as shown FIG. 10A and 10D As shown, a hot surface of the TEC is in contact with a surface of a heat exchanger, for example a water-cooled heat exchanger 1016. In some embodiments, the heat exchanger 1016 is configured to cool the hot surface of the TEC by a coolant fluid 1018 within the heat exchanger. In some embodiments, the coolant fluid 1018 is circulated between a cooling system in a control console and the heat exchanger 1016 of the applicator through a plurality of ports 1016 of the heat exchanger.

[0545] According to some example embodiments, for example, as shown FIG. 10A As shown, a heat sink 1014 is located between a hot surface of the TEC and a surface of the heat exchanger 1016.

[0546] According to some example embodiments, the applicator comprises at least one main printed circuit board (PCB) having a flexure portion 1024 electrically connected to a rigid board 1030. In some embodiments, the PCB transmits an electrical power signal to the plurality of transducers and receives electrical signals from the plurality of transducers and / or the at least one temperature sensor, for example the at least one thermistor 1010. In some embodiments, the flexure portion 1024 of the PCB is flexed and shaped to bend at least partially around the holder 1022 to electrically connect the plurality of transducers and / or the at least one thermistor to the rigid board 1030.

[0547] According to some example embodiments, an intensifier assembly of the applicator 1002 includes the plurality of PZT elements 1008 disposed on the holder 1022, the TEC 1012 in contact with the holder 1022, and the heat exchanger 1016. Additionally, the intensifier assembly includes the PCB, e.g., the flex PCB coupled to the plurality of transducers and / or plurality of thermistors.

[0548] According to some example embodiments, the intensifier assembly is sealed from liquid and / or air, e.g., by a gasket 1026 placed around the holder 1022 and a cap 1028 securely coupled to the gasket 1026.

[0549] Example intensifier assembly

[0550] According to some example embodiments, a PZT-holder assembly of an intensifier is configured to resist pressure exerted on the plurality of PZT elements, e.g., during contact of the applicator with the skin. In some embodiments, to resist the exerted pressure, the PZT elements are bonded to a holder, e.g., to limit movement of the PZT under the exerted pressure. Additionally, the plurality of PZT elements is sealed by at least one sealing layer, e.g., to prevent liquid and / or air from contacting the electrically conductive components of the intensifier. Referring now to FIG. 11A and 11B showing interactions between layers of an intensifier unit according to some example embodiments of the present application.

[0551] According to some example embodiments, a PZT element, e.g., PZT 1102, has a longitudinal axis 1103 and includes a first electrode contact, e.g., upper electrode 1104, and a second electrode contact, e.g., lower electrode 1106. In some embodiments, a thickness of a PZT element is in a range of 150 μιη to 220 μιη, e.g., 150 μιη to 180 μιη, 170 μιη to 200 μιη, 180 μιη to 220 μιη, or values in any intermediate, smaller, or larger range.

[0552] According to some example embodiments, the upper electrode 1104 and the lower electrode 1106 are electrically conductive and configured to deliver electrical power to the PZT element 1102. In some embodiments, a conductive layer 1108 includes a non-conductive filler 1109, such as a non-conductive adhesive, and a plurality of conductive particles 1107, such as layer 1108, between the lower electrode 1106 and a conductive metal strip, such as a copper strip 1110. In some embodiments, electricity is transmitted between the copper strip 1110 and the lower electrode 1106 through the plurality of conductive particles in the layer 1108.

[0553] According to some example embodiments, such as during manufacturing, pressing the PZT element against the copper strip 1110 allows the PZT element to move within the layer 1108 until a single layer of the plurality of conductive particles between the lower electrode 1106 of the PZT and the copper strip below the layer 1108 is formed within the layer 1108. In some embodiments, the plurality of particles in the layer 1108 have a similar size and / or diameter.

[0554] According to some example embodiments, optionally, at least 10%, such as at least 20%, at least 30%, at least 40%, or any intermediate, smaller, or larger percentage of the volume of the filler 1109 includes the plurality of conductive particles 1107.

[0555] According to some example embodiments, the lower copper strip 1110 has a thickness in a range of 30 pm to 80 pm, for example 30 pm to 50 pm, 40 pm to 70 pm, 60 pm to 80 pm, or values in any intermediate, smaller or larger range. In some embodiments, a layer of glue, for example a non-conductive glue layer 1112, is located between the lower copper strip 1110 and a surface of a thermally conductive holder, for example an aluminum holder 1114. In some embodiments, the non-conductive glue layer 1112 between the holder 1114 and the lower copper strip 1110 is a rigid glue layer. In some embodiments, pressing the PZT element against the holder 1114 by the adhesive layer 1108 allows, for example, fixing the attachment of the PZT element to the holder and optionally eliminates future movement of the PZT, for example in response to pressure from the skin. Alternatively or additionally, due to the conductive particles of a single layer of the layer 1108, for example, the PZT element 1102 maintains an equal distance from the holder along the entire surface of the PZT element 1102, forming the conductive particles of a single layer by pressing the PZT element against the holder 1114 by the adhesive layer 1108, levels the PZT element in a horizontal plane perpendicular to the longitudinal axis 1103 of the PZT element 1102.

[0556] According to some example embodiments, an upper electrode 1104 of the PZT element 1102 is coupled to a conductive strip, for example a silver strip 1117, by a gap (spark) welding.

[0557] According to some example embodiments, a layer of strong non-conductive glue, for example a non-conductive strong epoxy glue 1118, is applied on top of the upper electrode 1104 of the PZT 1102, for example to ensure a strong adhesion between the PZT element 1102 and other components of the booster. In some embodiments, the layer of strong non-conductive glue 1118 has a thickness in a range of 5 pm to 20 pm, for example 5 pm to 15 pm, 7 pm to 12 pm, 20 pm to 20 pm, or values in any intermediate, smaller or larger range.

[0558] According to some example embodiments, a polyimide layer, such as Kapton layer 1120, covers the non-conductive strong adhesive 1118. In some embodiments, the Kapton layer 1120 has a thickness in a range of 10-14 pm, such as 10 pm, 12 pm, 12.5 pm, 13 pm, or any intermediate, smaller or larger value. In some embodiments, an additional parylene coating 1122 is formed on top of the Kapton coating, such as to prevent direct contact between the PZT element 1102 and the skin, and / or to prevent the PZT element 1102 from being exposed to liquids and / or air.

[0559] According to some example embodiments, the parylene coating 1122 is a parylene-C coating having a thickness of at least 5 pm, such as at least 8 pm, at least 10 pm, or any intermediate, smaller or larger value. In some embodiments, gaps, such as pre-designed gaps between the frame and the holder, allow, for example, the coating to penetrate into the internal cavity between the frame and the holder, and to cover, for example, uniformly cover all surfaces.

[0560] Potential advantages of the parylene coating can be one or more of: biocompatibility of an applicator surface configured to be in contact with a skin of a subject, electrical isolation of all the exposed conductive surfaces and corrosion prevention within the frame cavity, mechanical stiffening and stability of the thin silver strips and the PZT positioning, increased electrical isolation of an applicator surface configured to be in contact with the skin / surrounding environment, and increased sealing preventing water and humidity penetration through the applicator surface.

[0561] According to some example embodiments, the copper strips 1110 electrically connected to the lower PZT electrodes 1106 are electrically isolated from the aluminum holder 1114, such as by a non-conductive glue film, and optionally by passivation of the aluminum surface. In some embodiments, the electrical isolation of the copper strips allows, for example, to measure the capacitance and / or impedance on each PZT separately, with minimal or no error / noise from other PZT elements, and optionally, no capacitive effect of the water electrolyte on the flex outer surface. In addition, it would also allow different transducers to be operated separately at different phases and / or different frequencies.

[0562] Reference is now made to FIG. 11B depicting a conductive layer comprising a non-conductive filler and electrically conductive particles within the filler, wherein the particles are located between an electrode of the PZT and an electrical conductor, according to some example embodiments of the present application.

[0563] According to some example embodiments, at least one electrode of the PZT element 1102, such as the lower electrode 1106, is placed in contact with the electrically conductive layer 1108, which includes a non-conductive filler 1109 and a plurality of electrically conductive particles 1107. In some embodiments, at least 50% of the plurality of particles 1107, such as at least 60%, at least 80%, at least 90%, at least 95%, or any intermediate, smaller, or larger percentage of the plurality of particles 1107, have a similar size or diameter. Optionally, at least 60%, at least 80%, at least 90%, at least 95%, or any intermediate, smaller, or larger percentage of the plurality of particles 1107 have a spherical or circular shape.

[0564] According to some example embodiments, a size or diameter of the plurality of particles differs from an average size or diameter of the plurality of electrically conductive particles in the non-conductive filler 1109 by less than 10%, such as less than 8%, less than 5%, less than 4%, or any other intermediate, smaller, or larger value.

[0565] According to some example embodiments, the plurality of particles is arranged in a single layer between at least one electrode of the PZT, such as electrode 1106, and an electrical conductor, such as copper strip 1110. In some embodiments, the at least one electrode and the electrical conductor contact the plurality of particles 1107 at two different points of contact, such as at two different points of contact on a curved outer surface of the plurality of particles 1107. Optionally, the two points of contact are points on a circumference of a particle and are located on the same diameter of the particle.

[0566] According to some example embodiments, the plurality of particles 1107 conduct electricity between the at least one PZT electrode and the electrical conductor through the plurality of points of contact. In some embodiments, at least some or all of the plurality of particles 1107 include a non-conductive core, such as a polymeric core, surrounded by a layer of electrically conductive material, such as an electrically conductive metal. In some embodiments, the plurality of points of contact between the plurality of particles 1107 and the at least one electrode and the electrical conductor are located on the electrically conductive layer of each particle. In some embodiments, electricity is conducted through the circumference of each particle between the two points of contact, rather than through the core of each particle.

[0567] According to some example embodiments, the circumferential conductive layer of each particle is made of a thermally conductive material. In some embodiments, the plurality of particles 1107 conduct heat away from the PZT element through the surrounding layer of each particle, such as towards a holder, a heat sink, or a cold surface of a TEC.

[0568] According to some example embodiments, the surrounding layer of each particle or plurality of particles 1107 is formed of a softer material, optionally elastic, as compared to the material of the rigid core of each particle. In some embodiments, the soft surrounding layer of each particle in contact with the at least one electrode of the PZT element allows, for example, less attenuation of the vibrations of the plurality of PZT elements as compared to a surrounding layer made of a rigid material. In some embodiments, the surrounding layer of each particle in contact with the PZT element or the at least one electrode of the PZT element is configured to elastically bend when the PZT element vibrates.

[0569] Example coupling of a conductive strip to a PZT electrode

[0570] Reference is now made to FIG. 12A and 12B which depict coupling of a conductive strip to an upper PZT electrode, according to some example embodiments of the present application.

[0571] According to some example embodiments, an upper PZT electrode 1116 is shaped and sized to be pressed by a skin surface of the applicator. In some embodiments, the upper PZT electrode 1116 is planar and flat, for example, does not include protrusions and / or bumps extending towards the skin, to prevent injury to the skin when the applicator is pressed against the skin.

[0572] According to some example embodiments, a conductive thin strip 1117 is coupled to the upper PZT electrode 1116 by spark welding, rather than soldering. In some embodiments, the strip 1117 is a flat and wide strip, having a width in a range of 0.8mm to 2mm, for example, 0.8mm to 1.5mm, 1mm to 1.2mm, 1.2mm to 2mm, or any intermediate, smaller or larger range of values.

[0573] Potential advantages of using spark welding rather than soldering can include preventing solder bumps and / or stress concentration when pressing the PZT element from above, for example, when the applicator is pressed against the skin, and preventing the use of solder, thereby allowing repeatable transfer-pad electrode area coverage.

[0574] Potential advantages of a wide conductive strip can be a greater current conductivity as compared to a wire, and / or suitability for mass production using standard commercial PCB automated planar assembly techniques.

[0575] Example flex PCB with thermistors

[0576] Reference is now made to FIG. 13A and 13BFIG. 13A depicts a flex PCB with a circuit of multiple thermistors according to some example embodiments of the application.

[0577] According to some example embodiments, for example, as shown in FIG. 13A FIG. 13A, a flex PCB, for example flex PCB 1302, includes a circuit of multiple thermistors. In some embodiments, the flex PCB 1302 is a flex Kapton (polyimide) PCB. In some embodiments, a thickness of the flex PCB varies, for example a thickness of an area designed to sit on top of multiple PZT elements is in a range of 15-30 pm, for example 15-25 pm, 20-30 pm, or values in any intermediate, smaller, or larger range. In some embodiments, a thickness of other areas of the flex PCB is in a range of 80-120 pm, for example 80-100 pm, 90-110 pm, 100-120 pm, or values in any intermediate, smaller, or larger range.

[0578] According to some example embodiments, the flex PCB includes a wide electrical routing area 1308, and a wide distal area 1304 between the electrical routing area 1306 and a distal end of the flex PCB, without electrical routing. In some embodiments, the flex PCB includes a narrow electrical routing area con, which is more rigid than the area 1308. In some embodiments, an arrangement of multiple thermistors on the flex PCB matches an arrangement of multiple PZT elements, for example a bend of the flex PCB positions the multiple thermistors of the flex PCB between adjacent PZT elements, for example, as shown in FIG. 13B FIG. 13B. In some embodiments, the flex PCB is oriented in a way that does not place the electrical routing of the flex PCB 1302 between the PZT elements and the skin, for example upside down, when installed.

[0579] According to some example embodiments, the flex Kapton PCB 1302 is configured to seal the booster assembly from one or more of water / moisture / ultrasound gel, etc. In some embodiments, the small thickness of the flex Kapton PCB over the PZT elements allows, for example, the ultrasound energy to pass through the flex PCB material with negligible energy loss. Additionally, the relative rigidity of polyimide allows, for example, better resistance to various physical impacts from the environment, for example, to maintain the seal of the booster.

[0580] A potential advantage of using a flexi-Kapton PCB can be to allow the flexi-PCB to be manufactured in a variety of standard mass production methods, for example, to reduce manufacturing costs. In addition, the flexi-Kapton PCB can allow electrical isolation from the skin / surrounding environment, for example, an electrical potential of at least 1500 volts, for example, at least 1700 volts, at least 2000 volts, at least 2500 volts, or any intermediate, lesser, or greater value. In addition, the small thickness of the flexi-Kapton PCB allows, for example, rapid heat transfer from the skin to the thermistors, allowing continuous updating of the temperature measurements of the skin, and the thermistors serve as aligners, correcting the positioning of the flexed portion of the flexi-PCB by optionally positioning the thermistors of the flexi-region in specific grooves of the frame.

[0581] In addition, the flexi-PCB allows a simple electrical connection of the flexi-circuit to the applicator main PCB.

[0582] According to some example embodiments, the flexi-PCB 1302 includes a wide, electrically wired region 1306, and a wide, distal region 1304 between the electrically wired region 1306 and a distal end of the flexi-PCB 1302, with no electrical wiring. In some embodiments, the flexi-PCB 1302 also includes a narrow, electrically wired region 1308 that is more rigid than region 1306. In some embodiments, the rigid, narrow, electrically wired region 1308 of the flexi-PCB 1302 serves as a connector and allows, for example, a simple electrical connection of the flexi-circuit to an applicator main PCB.

[0583] According to some example embodiments, the arrangement of thermistors 1153 on the flexi-PCB 1302 matches the arrangement of the spaced apart transducers 1150, for example, the flexing of the flexi-PCB 1302 positions the thermistors 1153 of the flexi-PCB 1302 between adjacent transducers 1150, for example, as shown in FIG. 16C In some embodiments, the position of the spaced apart thermistors 1153 proximate each ultrasound transducer 1150, which can optionally be about 1.0 mm thick, allows, for example, monitoring of the skin and treated skin area temperature and transmitting it in real time to a console.

[0584] Although Kapton is not an effective heat conductor, the small thickness of the flexi-PCB 1302 made of Kapton allows, for example, rapid heat transfer from the skin to the thermistors 328, thus optionally allowing continuous updating of the temperature measurements of the skin.

[0585] Reference is now made to FIG. 13C to 13DFIG. 13B depicts an assembly of the flex PCB on top of the plurality of PZT elements, in accordance with some example embodiments of the application.

[0586] According to some example embodiments, the flex PCB, e.g., the flex Kymera PCB, includes two or more openings, e.g., openings 1320 and 1322, shaped and sized to allow a plurality of PZT elements arranged in an array to pass through the flex PCB 1302. In some embodiments, once the flex PCB is positioned such that the plurality of PZT elements pass through the plurality of openings, e.g., openings 1320 and 1322, a frame 1330 is positioned on top of the flex PCB 1302, e.g., to adhere the flex PCB to the holder 1332.

[0587] According to some example embodiments, a strong adhesive, e.g., EpoTEK ND353 glue, is used between the PZT and a frame 1330 and the flex PCB 1302. In some embodiments, after the glue is applied, pressure is applied to the assembly while it is curing in an oven. In some embodiments, the oven is heated to a temperature of 120°C during the curing process.

[0588] According to some example embodiments, pressing the glue during the curing process allows, e.g., with a very thin, e.g., 15-30 μιη (~20 μιη) thick, glue, the flex glue to adhere to the silver electrodes on the PZT, e.g., to prevent loss of ultrasonic energy in the glue layer. Optionally, the EpoTEK ND353 glue mechanically fixes and supports the entire structure of the plurality of silver strips and the plurality of PZT elements, which are weakly supported on the soft conductive glue film containing the plurality of particles.

[0589] According to some example embodiments, e.g., as FIG. 13C and 13DAs shown, the electrical wiring connecting to the plurality of ultrasonic transducers and / or including the plurality of thermistors, e.g., the flex PCB 1302, is optionally unpassivated, e.g., to keep a distance between a transmitting surface of each ultrasonic transducer and a skin surface as short as possible, e.g., to improve the efficiency of ultrasonic energy delivery to the skin. In some embodiments, portions of the electrical wiring between the plurality of ultrasonic transducers and a transmitting surface of the ultrasonic applicator configured to contact the skin are unpassivated, while other portions of the electrical circuit, e.g., portions 1321 away from the transmitting surface of the ultrasonic applicator, are passivated. Optionally, all electrical conductors or wires between the plurality of ultrasonic transducers and a transmitting surface of an ultrasonic transducer are unpassivated. In some embodiments, all of the electrical circuit or conductors that energize the plurality of ultrasonic transducers are unpassivated.

[0590] Exemplary positioning of PZT elements on a holder

[0591] According to some exemplary embodiments, each PZT element is positioned on a surface of a thermally conductive holder, e.g., to allow heat transfer from the PZT element to the holder. Reference is now made to FIG. 14A and 14B depicting a PZT holder assembly according to some exemplary embodiments of the present application.

[0592] According to some exemplary embodiments, a thermally conductive holder 1406 includes two or more upwardly extending protrusions, e.g., protrusions 1408 and 1410, optionally shaped as fingers. In some embodiments, an upper surface of each protrusion is planar and shaped and dimensioned to attach to a PZT element. In some embodiments, e.g., as shown in FIG. 14B the upper surface 1409 of a protrusion 1408 has a dimension, e.g., a width 1414, that is greater than a dimension, e.g., a width 1412, of a PZT element 1411. In some embodiments, a width 1414 is at least 0.1 mm greater than a width 1412 of the PZT element. For example, a PZT width is about 1 mm, a width 1414 of a surface of the holder on which the PZT is located is about 1.3 mm to 1.7 mm, e.g., 1.3 mm to 1.5 mm, 1.4 mm to 1.7 mm, or any intermediate, smaller or larger range of values.

[0593] A number of potential advantages of a number of wide holder surfaces for mounting a number of PZT elements can be to allow for residual glue, for example residual ND353 glue, to accumulate on the number of side faces of the number of PZT elements, for example to provide mechanical support and adhesion of the PZT from the number of PZT side faces to the holder surfaces, to allow for sealing the PZT, preventing parylene penetration between the PZT electrodes and the glue, and to allow for small errors in the PZT position alignment on the holder surfaces.

[0594] A flex PCB of an exemplary number of transducers

[0595] Reference is now made to FIG. 15A and 15B depicting a flex PCB of an applicator configured to deliver current to a number of ultrasound transducers, according to some exemplary embodiments of the present application.

[0596] According to some exemplary embodiments, the number of ultrasound transducers are energized by electrical wiring or a number of electrical conductors attached to an electrode on a surface of each ultrasound transducer, the electrode facing a transmitting surface of the ultrasound applicator. Alternatively, the number of ultrasound transducers are energized by electrical wiring or a number of electrical conductors that penetrate and / or contact a base, for example holder 1406, on which the number of ultrasound transducers are positioned.

[0597] According to some exemplary embodiments, a flex PCB of a transducer, for example flex PCB 1502, comprises a rigid circuit board 1504 and an interacting portion 1508 of a number of transducers, electrically connected by a conductive flex region, for example flex 1506. In some embodiments, the interacting portion 1508 of a number of transducers comprises two electrically connected rigid boards 1510 and 1512, for example rigid PCBs. In some embodiments, the two rigid boards 1510 and 1512, for example rigid PCBs, are spaced apart. In some embodiments, the two rigid boards 1510 and 1512 are at least partially separated by a gap 1514. In some embodiments, the two rigid boards 1510 and 1512 are shaped and dimensioned to be positioned on two sides, for example on the two longest sides of a number of transducers holder, for example FIG. 14A The protrusions 1408 and 1410 shown penetrate the gap 1514. In some embodiments, the two rigid boards 1510 and 1512 are shaped and dimensioned to be positioned on two sides, for example on the two longest sides of a number of transducers array.

[0598] According to some example embodiments, the flex PCB is a rigid-flex rigid-flex rigid-flex rigid-flex PCB configuration, all parts are optionally 50 Ohm matched. In some embodiments, the flexibility of the transducer interaction portion 1508, and the independent movement of each of the transducer boards 1510 and 1512, allows, for example, bending of the PCB structure to fit on the holder structure, allows, for example, a simple assembly process, and optionally passes multiple radio frequency (RF) signals in the flex portion.

[0599] According to some example embodiments, the flex 1506 contains all the RF power channels, which are shielded from ground on both sides, for example, to allow low electromagnetic compatibility (EMC), low interference, or multiple variations in capacitance and impedance of the channels, and does not require connectors and / or coaxial wire soldering.

[0600] According to some example embodiments, for example, as shown in FIG. 15B The two boards of the transducer interaction portion 1508, for example, the transducer boards 1510 and 1512, are electrically connected by a flex strip 1509. In some embodiments, the flex strip 1509 allows the transducer boards to bend at least 180 degrees relative to each other, for example, to allow positioning of the transducer boards on both sides of a transducer holder.

[0601] According to some example embodiments, for example, as shown in FIG. 15C The flex PCB of the applicator has pads on the bars, for example, bars 1520 and 1522 on each side of a PZT. In some embodiments, placing the solder foot pads on the bars can allow, for example, a shorter distance from the PZT to the pads to a bottom copper strip and / or an upper silver strip, which can result in easier assembly, less EMC, and / or less parasitic capacitance and / or impedance variations.

[0602] According to some example embodiments, a short flex extension 1524 extends from one of the transducer boards, for example, transducer boards 1512 and 1510, and contains a temperature sensor, for example, a thermistor 1526 for recording the temperature of the holder 1406.

[0603] According to some example embodiments, an RF phase pole of the applicator PCB includes a short extension flex, such as flex 1524 on which the holder temperature thermistor is positioned. In some embodiments, the flex 1524 tip and the thermistor 1526 are positioned in a hole in the holder side and optionally glued to the holder 1406 with a thermally conductive glue. Using a separate thermistor to record a holder’s temperature and attaching the thermistor to the holder using a glue allows, for example, simple assembly of the booster for temperature measurement of the holder temperature, fast planar assembly of the applicator PCB and holder thermistor, no manual soldering, direct transfer of the thermistor reading to the circuit board 1504 of the PCB through the flex 1506.

[0604] According to some example embodiments, for example, as shown in FIG. 15D According to some example embodiments, for example, as shown in FIG. 9A According to some example embodiments, for example, as shown in

[0605] According to some example embodiments, for example, as shown in FIG. 15E According to some example embodiments, for example, as shown in

[0606] According to some example embodiments, for example, as shown in FIG. 15EAs shown, a circuit board within the applicator includes a plurality of measurement receiving circuits, such as circuit 1550. In some embodiments, the circuit 1550 includes an A2D converter 1558 configured to receive a plurality of signals 1552 from a holder thermistor, which are received from at least one thermal sensor configured to record temperature levels of a thermal conductor contacting the plurality of transducers of the applicator, such as a plurality of ultrasound transducers. In some embodiments, the plurality of signals of the holder thermistor are indicative of a temperature of the plurality of transducers. Additionally or alternatively, the converter 1558 is configured to receive a plurality of signals 1554 from a surface plurality of thermistors, which are received from at least one thermal sensor configured to record temperature levels of an area of skin contacting the applicator. In some embodiments, the plurality of signals 1552 of the holder thermistor and the plurality of signals 1554 of the surface plurality of thermistors are received from a connector 1560 on the circuit board, which is optionally connected to at least one PCB including two or more thermistors, such as a flex PCB. In some embodiments, the A2D converter readings are transmitted on the PCB to a communication circuit, such as a SPI communication chip, from which the information of the temperatures is transmitted to the system through the umbilical channel.

[0607] Exemplary applicator assembly

[0608] According to some exemplary embodiments, during the assembly of the applicator, some of the gaps within the various components of the applicator, for example, are sealed using a filling material, for example, to prevent interaction between electrical components and components of the cooling system. In addition, at least some of the gaps within the applicator are filled with an adhesive, for example, to minimize movement of the components and to isolate some of the components, for example, the tubes of the cooling system, from liquid and / or humid air, to prevent condensation of water on the cooling system tubes. Reference is now made to FIG. 16A depicting assembly of the applicator components according to some exemplary embodiments of the present application.

[0609] According to some example embodiments, a parylene-C coated booster assembly is covered with an outer applicator cover and a grommet. In some embodiments, a silicone filler, such as a non-acidic RTV silicone, is placed around and inside a gap between an outer cover and the heat exchanger to seal it from water and air penetration. In some embodiments, sealing the gap between the cover and the heat exchanger can achieve one or more of the following: prevent water condensation and / or freezing on the booster holder due to humid air or condensation water on the water tubes, prevent water or other liquid penetration into the frame space and close to the PZT elements, which can cause changes in the PZT mechanical support or stress, electrical impedance changes, and / or changes in the sensitivity of thermistor measurements.

[0610] According to some example embodiments, the electronics card of the main PCB is secured in a first applicator cover with screws. In some embodiments, the booster is positioned in pre-designed pins of the cover, which are shaped and sized to fit into complementary openings in the opposite and complementary applicator cover. In some embodiments, securing the electronics card of the PCB can allow one or both of the following: avoid damage due to stress on the flexure parts of the main flexure PCB, such as the transducer's flexure PCB, and provide mechanical support against the pulling forces of the electrical wiring applied in the umbilical channel.

[0611] According to some example embodiments, such as shown in FIG. 16A a filler material, such as soft silicone, is added to the inner cavity of the applicator to fill at least part of the inner cavity. In some embodiments, the electrical connectors of the top cover switch and LED are connected to the PCB rigid card. In some embodiments, an umbilical channel insert is correctly aligned with respect to the applicator body, and a first applicator housing is closed and glued, such as with a glue. In some embodiments, the applicator body is tilted at an angle of less than 90 degrees, such as an angle of 45 degrees, and then soft silicone filler material is injected into the applicator body to fill the inner cavity of the applicator body up to an opening of the upper panel including the user interface of the applicator. Optionally, the filler material of the main flexure PCB of the applicator is used for partial filling, such as to reduce the weight of the applicator body.

[0612] Filling at least partially the inner cavity of the applicator body with silicone or any other curable filler material can allow one or more of the following: preventing condensation of water on the plurality of water tubes due to penetration of humid air into the applicator body, preventing dripping and seepage of water into the plurality of electrical connectors of the rigid plate of the flex PCB and / or plurality of TEC connectors, electrically isolating the plurality of surrounding components, preventing dripping from the applicator head when condensation occurs, and mechanically stabilizing the applicator body.

[0613] Exemplary applicator assembly and parts

[0614] Reference is now made to FIG. 16B which depicts an applicator assembly comprising an array of ultrasonic transducers suitable for use in the skin treatment method, in accordance with some exemplary embodiments of the present application.

[0615] According to some exemplary embodiments, an applicator assembly, such as applicator 1134, comprises an applicator body 1136 and an umbilical connection channel 1138. In some embodiments, the umbilical connection channel 1138 couples the applicator body 1136 to a distal end of the umbilical connection channel 1138. In some embodiments, a proximal end of the umbilical connection channel 1138 comprises at least one console connector 1140 configured to connect the applicator 1134 to a console (not shown) of an ultrasonic system. In some embodiments, the console connector 1140 comprises at least one ground pin 1142 configured to allow grounding of the ultrasonic applicator 1134. Additionally, the at least one console connector 1140 of the umbilical connection channel 1138 comprises at least one coolant connector 1144 configured to connect a cooling system of the ultrasonic applicator 1136 to a cooling system of the console, for example, to allow circulation of coolant between the applicator 1136 and the console.

[0616] According to some exemplary embodiments, the applicator body 1136 comprises an elongated handle 1145 having at least one gripping member shaped and sized to be held by a hand of an operator. In some embodiments, the ultrasonic applicator 1136 comprises a firing head portion 1146 oriented at an angle of between 70 degrees and 180 degrees, or any intermediate, smaller or larger range of angle values, relative to the handle 1145. A potential advantage of positioning a firing head portion at an angle relative to a handle of the applicator can be to allow easy directing of a firing head portion to a treatment area of a subject and / or easier application of force by an operator by resting the applicator 1136 on the treatment area.

[0617] According to some example embodiments, the handle 1145 of the applicator 1134 includes a user interface comprising at least one activation switch 1150 and / or at least one visual indicator, such as an LED 1152. In some embodiments, the applicator 1134 includes an audible indicator configured to produce at least one human-detectable indication to an operator holding the handle 1145. In some embodiments, the user interface is oriented on the handle 1145 at a distance from at least one gripping member of the handle 1145 selected to allow holding and activation of the user interface with the same hand of an operator. In some embodiments, the user interface is positioned on the handle 1145 within a field of view of an operator holding the applicator 1136.

[0618] Reference is now made to FIG. 16D which is a cross-section through a head portion 1146 of an applicator 1136 shown in FIG. 16C FIG. 1 1.

[0619] According to some example embodiments, the head portion 1146 includes a plurality of spaced-apart ultrasonic transducers 1150, such as two or more ultrasonic transducers 1150. In some embodiments, the plurality of transducers 1150 are positioned near a surface of the head portion 1146 shaped and dimensioned to be in contact with the skin. In some embodiments, the plurality of ultrasonic transducers 1150 are configured to emit a plurality of non-converging ultrasonic waves. In some embodiments, the plurality of transducers 1150 are linearly organized in the form of an array under and near the skin-contacting surface 1148 of the head portion 1146 shown in FIG. 16B FIG. 1 1. In some embodiments, the plurality of ultrasonic transducers 1150 deliver the generated ultrasonic energy to the surface of the skin and to a plurality of deeper tissue layers.

[0620] According to some example embodiments, the head portion 1146 includes a frame or cover 1152 covering and optionally incorporating a thermally conductive holder 1154, a plurality of ultrasonic transducers 1150 and a thermoelectric cooler 1156.

[0621] According to some example embodiments, each ultrasonic transducer 1150, including for example a PZT element, is positioned on a surface of the thermally conductive holder 1154 to allow, for example, heat transfer from the transducer 1150 to the holder 1154. In some embodiments, the thermally conductive holder 1154 includes two or more protrusions, for example upwardly extending protrusions 1158, optionally shaped as fingers. In some embodiments, the upper surface of the protrusions 1158 is planar and optionally shaped and sized to attach to a surface of a transducer 1150, for example to a planar surface of a PZT element of the transducer.

[0622] In some embodiments, an upper surface of each protrusion 1158 is planar and configured to be in contact with a temperature sensor, for example a thermistor.

[0623] According to some example embodiments, a width 1160 of an upper surface of a protrusion 1158 is greater than a dimension, for example a width 1162 of a transducer 1158, for example a PZT element of the transducer 1158. The width 1160 is at least 0.1 mm greater than the width 1162 of the transducer 1150. For example, a width 1162 of a transducer 1150 is about 1 mm and a width 1160 of a surface of the holder on which the transducer 1150 is positioned is in a range of about 1.3 mm to 1.7 mm, for example 1.3 mm to 1.5 mm, 1.4 mm to 1.7 mm or any intermediate, smaller or larger range of values. In some embodiments, a cross section of the protrusions 1158 is selected to support the optimal heat exchange process between the transducer 1150, for example a PZT element of the transducer 1150, and the thermoelectric cooler (TEC) 1156.

[0624] According to some example embodiments, a surface of the thermally conductive holder 1154 is placed in contact with a cold surface of a thermoelectric cooler (TEC) 1156. In some embodiments, the thermally conductive holder 1154 is configured to transfer heat from one or more transducers 1150 to a cold surface of the TEC 1156. Optionally, the thermally conductive holder 1154 is configured to cool the surface of a transducer 1150 that is in contact with or positioned close to the skin, for example when a layer of an insulating material is placed between the transducer and the skin. In some embodiments, the thermally conductive holder 1154 includes or is at least partially made of a thermally conductive material, for example aluminum.

[0625] A number of potential advantages of a number of wide thermally conductive surfaces of holders 1154 for mounting the number of transducers 1150 can be to allow excess glue, such as excess ND353 glue, to accumulate on the number of sides of the number of transducers, such as the number of PZT elements, and to provide mechanical support and adhesion of each of the number of transducers 1150 from the transducer sides to the thermally conductive holder 1154 surfaces. In some embodiments, mounting the number of transducers 1150 on a wide surface of a number of protrusions of the holder allows, for example, sealing of the PZT elements to prevent polystyrene from penetrating into a gap between the PZT elements and the glue. Additionally or alternatively, mounting the number of transducers on a wide surface of a number of protrusions of the holder allows, for example, small errors in alignment of a transducer 1150, such as the PZT elements of the transducer being positioned on a planar surface of each protrusion 1158.

[0626] Exemplary umbilical connection channel

[0627] According to some exemplary embodiments, an umbilical connection channel is an elongated and flexible channel shaped and sized to connect an applicator body to a console. In some embodiments, the connection channel is irreversibly coupled to an applicator body, for example, to prevent an operator of the system from disconnecting the applicator body from the connection channel. In some embodiments, electrical wiring and at least one tube of the cooling system pass from the applicator body through the connection channel to a number of console connectors located at a proximal end of the connection channel.

[0628] According to some exemplary embodiments, both ends of the connection channel, for example, an end of the connection channel that connects to the applicator body, and an end of the connection channel that includes the number of console connectors, are sealed between the number of cables and the number of inserts in the number of spaces with a non-acidic RTV, to prevent humid air from penetrating into the connection channel. Air sealing of the connection channel can allow one or more of: minimizing or eliminating condensation of water in the air in the umbilical connection channel on the number of water tubes, minimizing or eliminating dripping of water from the inner cavity of the umbilical connection channel into the applicator space in case of condensation on the number of coolant fluid tubes, mechanically supporting the number of cables within the connection channel to prevent kinking.

[0629] According to some example embodiments, at least some or all of the plurality of cables within the umbilical connection channel are individually electrically shielded. In some embodiments, an additional electrical shield surrounds a bundle of all of the plurality of cables and is optionally electrically connected to the shields of the plurality of cables. In some embodiments, the plurality of cable bundle shield is electrically connected to the console chassis, rather than the RF or signal ground. The electrical shielding of the plurality of cables can allow an EMC shielding sufficient to pass multiple regulatory requirements.

[0630] Reference is now made to FIG. 17 depicting a plurality of console connectors of an umbilical connection channel according to some example embodiments of the present application.

[0631] According to some example embodiments, an umbilical connection channel 1702 is an elongated connection channel having a distal end 1706 connected to an applicator body 1708 and a proximal end 1704 including two or more connection channel connectors, such as electrical connectors and / or coolant fluid connectors connected to a console of an ultrasound system for delivering a plurality of skin treatments.

[0632] According to some example embodiments, the plurality of connection channel connectors includes an electrical connector, such as a pin 1714, configured to electrically connect the shield of the plurality of cables in the umbilical connection channel 1702 to the console, such as to a chassis of the console. In some embodiments, the pin 1714 is used to align the plurality of console connectors with a matching plurality of connectors in the console.

[0633] According to some example embodiments, the plurality of connection channel connectors includes at least one coolant fluid connector, such as a plurality of connectors 1710, configured to connect the cooling system of the applicator to the cooling system of the console.

[0634] According to some example embodiments, the electrical connectors of the umbilical connection channel to the console include a 48-pin connector 1712 that matches a 48-socket connector in the console for delivering US power from the console to the plurality of transducers in the applicator body 1708. In some embodiments, the use of a 48-pin connector can enable one or more of: low cost due to use of standard parts, simple assembly without soft soldering, and a simple applicator assembly by snapping the plurality of connectors into the plurality of sockets in the applicator main PCB.

[0635] According to some exemplary embodiments, the plurality of connection channel connectors of the connection channels are filled with a cured filler material, such as silicone, to cover multiple uninsulated portions of the 48 pin connectors and multiple wires. In some embodiments, adding a cured filler material to the plurality of connectors can allow electrical isolation between the plurality of pins, for example in the event of water penetration or condensation on the plurality of coolant fluid lines, and to prevent corrosion.

[0636] Exemplary console

[0637] Now for reference FIG. 18A and 18B It depicts a console of an ultrasound system for delivering multiple skin treatments according to some exemplary embodiments of the present invention.

[0638] According to some exemplary embodiments, a console, such as console 1802, includes a tower-shaped body having a vertical axis 1806, an upper end 1818, and a lower end 1810. In some embodiments, the ratio between a height 1803 and a width 1805 of the body is at least 1.5:1, such as 2:1, 3:1, or any intermediate, smaller, or larger ratio. In some embodiments, the console 1802 is movable, such as a movable console configured to move vertically on a surface, such as a floor.

[0639] According to some exemplary embodiments, an upper end 1808 of the body 1804 includes a user interface, such as a display 1812. In some embodiments, the display is tilted relative to the vertical axis 1806 at an angle ranging from 30 degrees to 90 degrees, such as 30 degrees to 45 degrees, 40 degrees to 50 degrees, 45 degrees to 65 degrees, or any of the intermediate, smaller, or larger angles.

[0640] According to some exemplary embodiments, the lower end 1810 of the body 1804 is coupled to a wheel seat 1814. In some embodiments, at least two wheels, such as wheels 1816 and 1817, are connected to a surface of the wheel seat facing a floor. In some embodiments, the at least two wheels are configured to allow the console 1802 to move on a surface, such as a floor.

[0641] According to some exemplary embodiments, the console 1802 includes an umbilical connection channel port, such as port 1820, configured to allow connection of the connection channel to the console 1802. In some embodiments, the console 1802 includes at least one handle, such as handle 1822, including at least one gripping member shaped and sized to fit within the palm of an operator's hand, for example, to allow manual movement of the console 1802 on the floor.

[0642] According to some example embodiments, for example, as shown in FIG. 18C The console 1802 includes two or more ultrasonic (US) power amplifier cards, for example, a plurality of power cards 1830 arranged in a support frame, for example, a chassis of the console. Additionally, the console includes a cooling system, for example, a cooling system 1832 located in a lower position within the chassis, close to the lower end of the main body, for example, lowering a center of mass of the console main body.

[0643] Example ultrasonic (US) power signal amplification and measurement

[0644] Reference is now made to FIG. 19A which depicts US power signal amplification and measurement, according to some example embodiments of the present application.

[0645] According to some example embodiments, a US PCB power card is electrically connected to a backplane PCB 1904 in the console. In some embodiments, the backplane PCB is electrically connected to the main PCB 1906 of the console.

[0646] According to some example embodiments, each US transducer receives an electrical power signal from a separate power channel. In some embodiments, each power channel is generated by a separate US card, for example, a US card 1902 located in the console. In some embodiments, the US card includes an amplifier, for example, an amplifier 1910 generating US electrical excitation according to a determined electrical power output.

[0647] According to some example embodiments, each US card, for example, a US card 1902 receives a control signal 1912 generated by a specific D2A channel or a D2A converter 1914. In some embodiments, the control signal 1912 is set by a control software of the console.

[0648] According to some example embodiments, the amplifier 1910, for example, a non-linear amplifier, generates a distorted sinusoidal signal 1916. In some embodiments, the distorted sinusoidal signal 1916 is fed to a low pass filter 1918 before the electrical power output is measured by a bidirectional coupler 1920. In some embodiments, the low pass filter is used to convert the distorted sinusoidal signal 1916 to a sinusoidal signal that can be measured by the bidirectional coupler, for example, to provide accurate measurement results.

[0649] According to some example embodiments, the low pass filter comprises at least one air coil, for example 2, 4, 6 or any intermediate, fewer or greater number of air coils. In some embodiments, each of the plurality of air coils is used for low RF frequencies, for example in an RF frequency of up to 100 MHz, for example up to 80 MHz, up to 50 MHz or any intermediate, smaller or greater value, and an amplitude, for example power of at least 1 Watt, for example 1.5 Watts, 3 Watts, 4.5 Watts, 5 Watts or any intermediate, smaller or greater number of Watts.

[0650] According to some example embodiments, each of the plurality of air coils is formed by winding a conductive wire, for example a copper wire, having a diameter of 1 mm to 2 mm on a cylinder having a diameter in the range of 5 mm to 15 mm, for example about 10 mm. Such air coils are not currently available as a standard product on the market, and are therefore custom made by winding a copper wire having a diameter of 1 to 2 mm on a cylinder having a diameter of 10 mm. We adjust the number of turns to obtain the required inductance values of the plurality.

[0651] According to some example embodiments, the low pass filter 1918 is configured to remove all the plurality of frequencies above a main frequency to produce a sinusoidal waveform output signal 1920 of the main frequency.

[0652] In some embodiments, the output signal passes through a bidirectional coupler 1922 and exits as a power output signal 1924.

[0653] According to some example embodiments, the following Table A describes the different signals in the US power card:

[0654]

[0655] According to some example embodiments, the measured output signals of the bidirectional coupler are 1 / 100 of the forward and reverse electrical power. In some embodiments, the measured output signals comprise two or more signals having 1 / 100 of the original signals. In some embodiments, in order to calculate the forward and reverse (reflected) power, the signals need to be sampled and the electrical power calculated. In some embodiments, since the signal 1920 produced by the low pass filter 1918 is a sinusoidal signal, the amplitude of the output signal is measured.

[0656] According to some example embodiments, during the measurement of the output signal, the forward and reverse signals are connected to a capacitor charging circuit, serving as a pickup detector, respectively, wherein the voltage level on the capacitor linearly depends on the amplitude of the signal measured by the bi-directional coupler. In some embodiments, the voltage on the capacitor is directly proportional to the amplitude of the sinusoidal signal. In some embodiments, each signal is sampled at a low frequency in a range of 10 Hz to 100 Hz, for example 10 Hz to 30 Hz, 20 Hz to 50 Hz, 40 Hz to 70 Hz, 60 Hz to 90 Hz, 50 Hz to 100 Hz, or any intermediate, smaller or larger range. In some embodiments, the voltage on the capacitor of each channel is measured by an A2D and read by the control software of the control console. Optionally, an initialization calibration scheme can allow calculating a measured power output from a measured voltage.

[0657] According to some example embodiments, the amplifier 1910 is configured to produce a high frequency radio frequency (RF) signal, for example an RF signal having a frequency in a range of 5 to 20 MHz, for example 5 to 10 MHz, 8 to 15 MHz, 10 to 20 MHz, or any intermediate, smaller or larger range. In some embodiments, a sinusoidal signal is produced from the high frequency RF signal, for example using a low pass filter, optionally comprising air coils, for example low pass filter 1918.

[0658] According to some example embodiments, a portion of the sinusoidal signal is sampled, for example 1 / 5, 1 / 10, 1 / 100, or any intermediate, smaller or larger portion of the signal. In some embodiments, the signal portion is delivered to a capacitor, for example a chargeable capacitor. In some embodiments, an RMS voltage of the sampled sinusoidal signal is calculated. In some embodiments, the calculated RMS voltage values are monitored. Alternatively or additionally, the variability of the calculated RMS voltage values is monitored. In some embodiments, according to the results of the monitoring, for example monitoring the calculated RMS voltage values and / or monitoring the variability of the RMS voltage values, an amplification is modified, for example values of at least one parameter of the amplification.

[0659] According to some example embodiments, an indication related to the amplitude of the sinusoidal signal is measured, for example a square of an amplitude value or any other mathematical variation of the amplitude is measured. In some embodiments, based on the measured amplitude indication, for example based on the measured square of the amplitude, a sound output of a plurality of ultrasonic transducers receiving the high frequency RF signal, for example the high frequency RF sinusoidal signal, is determined. In some embodiments, there is a linear relationship between the sound output and the measured amplitude indication, for example the square of the amplitude.

[0660] An underlying advantage of using the capacitor charging voltage measurement can be the ability to use a standard multi-channel A2D component and sample the signals at 10 to 100 Hz instead of sampling 14 signals at 100 MHz with 7 power signals present, or using a multiplexer. The problem that the configuration solves is that in order to measure the forward and reverse power levels using the bi-directional coupler, the measured signals of the bi-directional coupler need to be sampled and the RMS value Vrms of the signals calculated, the power is calculated by V^2 / R where R=50 Ohm of the coupler. The measured signals from the coupler are at the power signal frequency of 10 to 12 MHz. In order to calculate the Vrms of such a signal, it needs to be sampled at at least 100 MHz, where there are two such signals per power channel: forward and reverse. If there are 7 power channels, in this example, 14 signals need to be sampled at 100 MHz, or a related multiplexer is used, which creates an expensive and complex system for both options. However, by using the capacitor charging voltage measurement, a very simple and inexpensive standard multi-channel A2D component can be used and the signals can be sampled at 10 to 100 Hz.

[0661] Example US amplifier cards

[0662] Reference is now made to FIG. 19B to 19D which depicts ultrasonic (US) amplifier cards and their side-by-side arrangement within the console, according to some example embodiments of the present application. In some embodiments, a US amplifier card comprises a radio frequency (RF) signal amplifier card.

[0663] According to some example embodiments, a US amplifier card, e.g., card 1902, includes a filter, e.g., a low pass filter, formed by at least one, e.g., 2, 4, 6, or any intermediate, fewer, or greater number of air coils. In some embodiments, the plurality of air coils are used to generate an output sinusoidal signal. In some embodiments, the output sinusoidal signal can allow one or more of: correct power measurement, high efficiency of energy conversion to US power, and electric power measurement using a capacitor charge, which allows, e.g., multiple measurements at a low sampling rate.

[0664] According to some example embodiments, forward and reverse power measurements are performed in the US amplifier card 1902. Additionally or alternatively, impedance measurements are performed in the US amplifier card 1902.

[0665] According to some example embodiments, each US amplifier card, e.g., card 1902, includes at least one integrated connector, e.g., integrated connector 1930, e.g., as shown in FIG. 19B to 19D FIG. 19B According to some example embodiments, each US amplifier card, e.g., cards 1902 and 1904, is connected to a circuit board 1950, e.g., a backplane PCB board, within the console, e.g., by plugging the integrated connector of a US amplifier card into an integrated socket connector, e.g., socket connectors 1940 and 1942 of the circuit board 1950, e.g., as shown in

[0666] According to some example embodiments, placing two or more US amplifier boards, e.g., US amplifier cards 1906 and 1908, next to each other on the circuit board 1950 can cause electromagnetic interference to the measurement circuits on the boards. In some embodiments, to reduce or eliminate electromagnetic interference between closely packed US amplifier boards, each board is at least partially covered by at least one electromagnetic shield, e.g., shield 1932, in the form of a grid or a mesh. In some embodiments, the at least one shield covers the amplification circuits and / or the measurement circuits of the US amplifier card. Alternatively or additionally, the at least one shield covers at least 50%, e.g., at least 60%, at least 80%, at least 90%, or any intermediate, smaller, or greater percentage of the outer surface of the US amplifier card.

[0667] According to some example embodiments, the at least one electromagnetic shield includes a heat sink, e.g., heat sink 1934, connected to the US amplifier card.

[0668] According to some example embodiments, each US amplifier card, e.g., cards 1902 and 1904, includes at least one integrated connector, e.g., integrated connector 1930, e.g., as shown in FIG. 19E ​As shown, a minimum distance between multiple circuits, e.g., multiple amplification circuits and / or multiple measurement circuits, of two adjacent RF signal amplifier cards, e.g., cards 1906 and 1908, is at least 3 cm, e.g., at least 5 cm, at least 10 cm, or any intermediate, smaller, or larger distance. In some embodiments, a minimum distance between the multiple circuits is in a range of 1 cm to 12 cm, e.g., 1 to 8 cm, 5 to 10 cm, 8 to 12 cm, or any intermediate, smaller, or larger range of values.

[0669] Exemplary console cooling system

[0670] Reference is now made to FIG. 18C depicting a cooling system of the console according to some exemplary embodiments of the application.

[0671] According to some exemplary embodiments, e.g., as FIG. 18C As shown, the console includes a cooling system 1832. In some embodiments, the cooling system 1832 includes at least one pump, e.g., an electric pump, and a coolant fluid reservoir. In some embodiments, the pump is configured to circulate the coolant fluid between the reservoir and the applicator, e.g., a heat exchanger of the applicator.

[0672] Reference is now made to FIG. 20 depicting a flow of coolant fluid according to some exemplary embodiments of the application.

[0673] According to some exemplary embodiments, a cooling system controller 2012 activates a pump, e.g., a water pump 2002, to circulate coolant fluid, e.g., water, between a reservoir, e.g., a water tank 2004, and a US applicator in the console. In some embodiments, the water tank 2004 includes at least one water level sensor 2005 electrically connected to the controller 2012 and configured to record a water level within the water tank 2004.

[0674] According to some exemplary embodiments, the controller 2012 sends a signal to the pump 2002 to move water to a condenser 2008 configured to cool the water. In some embodiments, at least one flow sensor, e.g., a water flow sensor 2006, controls the water flow in the cooling system, e.g., the water flow into the condenser 2008. In some embodiments, the cooling system includes at least one valve, e.g., a solenoid valve electrically connected to the controller 2012. In some embodiments, the controller signals the solenoid valve to open, e.g., to allow water to flow into the applicator.

[0675] Exemplary umbilical connection channel connector of the console

[0676] According to some example embodiments, a console connector for the umbilical connection channel of the applicator is configured to allow electrical connection between the console and the applicator. Additionally, the console connector is configured to allow coolant fluid connection between the cooling system of the console and the applicator. Optionally, the console connector is configured to allow electrical connection to ground at least one electrical signal from the applicator.

[0677] According to some example embodiments, a console connector for an umbilical connection channel comprises at least one electrical connector, for example a socket connector, matching a 48-pin electrical connector of the connection channel, for example the 48-pin connector 1712 shown in FIG. 17

[0678] According to some example embodiments, the console connector comprises at least one coolant fluid connector matching a coolant fluid connector of the connection channel, for example the plurality of connectors 1710 shown in FIG. 17

[0679] According to some example embodiments, the console connector comprises a socket with a conductive leaf spring configured to ensure electrical conduction between the pins 1714 of the connection channel connector and an electrical wiring of the console when the pins 1714 are introduced into a socket of the console connector. FIG. 17

[0680] Example visual interface for an operator

[0681] According to some example embodiments, an operator of the system controls one or more parameters of the skin treatment, for example the total duration of the treatment, the duration of a treatment session, the type and number of treatment areas and / or the parameter values of the plurality of delivered ultrasound signals. In some embodiments, the operator adjusts one or more of the treatment parameters for a particular subject, for example based on physical and / or clinical characteristics of the subject, for example age, gender, skin type, degree of wrinkles, history of previous treatments, medication regimen and / or the subject's sensitivity to pain. In some embodiments, the operator uses a user interface of the console, for example a display of the console, to enter information about the subject and / or the treatment. Alternatively or additionally, the operator receives indications about the status of the system and the operational status of at least one system element, for example the transducers of the applicator.

[0682] Reference is now made to FIG. 21A and 21B ​​​Fig. 22 depicts a visual interface presented to an operator of the system, according to some exemplary embodiments of the present application.

[0683] According to some exemplary embodiments, a subject details interface 2202 is presented to an operator of the system. In some embodiments, the operator inserts details of a specific subject into a memory of the console, for example, to generate a personal profile of the subject and / or to provide a personalized treatment. In some embodiments, subject specific information inserted into a memory of the system is used to generate a database containing personal information of a subject, treatment history of the subject including treatment parameters and one or more of results of the treatments. In some embodiments, the information in the database is used to develop new treatment protocols and / or to improve existing protocols. In some embodiments, the database is generated in a cloud and / or a remote computer.

[0684] According to some exemplary embodiments, in a subject details interface, an operator inserts personal information of a subject, for example, one or more of birth year 2208, gender 2210, skin type 2212 and wrinkle level 2214. In some embodiments, a subject identifier 2206, for example, a number generated by the system for each subject, or generated by an operator.

[0685] According to some exemplary embodiments, an operator adjusts one or more of the treatment parameters in a treatment parameters visual interface 2203 to a specific subject. Alternatively, the interface presents parameter values of a stored treatment protocol automatically selected for a specific subject, for example, based on the personal profile of the subject. Optionally, the interface presents parameter values of an existing stored protocol, and the operator adjusts the values of the protocol parameters according to a personal profile of the subject.

[0686] According to some exemplary embodiments, a treatment parameters visual interface 2203 presents values of one or more parameters related to the ultrasound, for example, number of pulses 2221 in a sequence of pulses of ultrasound, pulse duration 2222, energy level of each pulse, duration of post cooling 2226. Additionally or alternatively, the interface 2203 presents a type of the treatment 2230, for example, a single pulse or a sequence of pulses, and / or an interval between adjacent pulses 2228.

[0687] According to some exemplary embodiments, the visual interface presents a treatment history 2232, including number or name of treatment areas, total energy delivered to a specific area and / or energy level of each pulse delivered to the area.

[0688] According to some example embodiments, the visual interface presents an indication, e.g., a graphical indication 2204, to describe a status or condition of the system and / or the applicator. Additionally or alternatively, the visual interface presents to the operator virtual buttons, e.g., a virtual button 2230, to allow changing a system status between different programming states, e.g., between on, off, standby and active states.

[0689] It is expected that during the life of a patent maturing from this application many relevant ultrasonic transducers will be developed; the scope of the term ultrasonic transducers is intended to include all such new technologies a priori.

[0690] As used herein, the term "about," with reference to a number or a value, means "within ±20 %."

[0691] The terms "comprise," "comprising," "include," "including," "have," "having," and their variants, mean "including but not limited to."

[0692] The term "consisting of means "including and limited to."

[0693] The term "essentially consisting of means that the composition, method or structure can include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0694] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" can include a plurality of compounds, including mixtures thereof.

[0695] Throughout this application, various embodiments of the application can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and

[0696] Whenever a numerical range is indicated herein (for example "10-15", "10 to 15", or any pair of numbers linked by such other range-indicating terms), it is meant to include any number (fractional or integral) within the indicated range limits, inclusive of the range limits, unless the context clearly dictates otherwise. The phrases "range between," "a range from," "a range to," "a range of," and "a range up to" (or other such range-indicating terminology) are used herein interchangeably and are meant to include the first and second indicated numbers, and all the fractions and integers therebetween.

[0697] Unless otherwise indicated, numbers used in this disclosure and any numerical ranges based thereon are approximations within a reasonable range of measurement precision and rounding error.

[0698] As used herein, the term "method" refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacologic, biological, biochemical and medical arts.

[0699] As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially improving a clinical or aesthetic symptom of a condition or substantially preventing the appearance of a clinical or aesthetic symptom of a condition.

[0700] It is to be understood that many alternatives, modifications, and variations will be apparent to those skilled in the art in light of the foregoing description. Accordingly, one or more embodiments of the present application are intended to embrace all such alternatives, modifications, and variations as fall within the scope of the appended claims. It will be appreciated that, for clarity and ease of understanding, the present application has been described in terms of particular embodiments. However, it is to be understood that the application is not limited to the specific arrangements described, but extends to any and all arrangements capable of attaining the same end result.

[0701] Although the application 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 as fall within the scope of the appended claims.

[0702] All publications, patents and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference. In addition, the citation of any reference herein should not be construed as an admission that such reference is available as "prior art" to the present application. The summary of the application is provided herein for ease of understanding, and should not be construed as a necessary limitation thereof. In addition, any priority document referenced herein is hereby incorporated by reference in its entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

Claims

1. An ultrasonic applicator of an ultrasonic system, comprising: an applicator body having at least one ultrasonic emitting surface shaped and sized to contact a skin; at least one ultrasonic transducer comprising a surface opposite to the at least one ultrasonic emitting surface and an electrode connected to the surface of the ultrasonic transducer; at least one electrical conductor; a filler layer disposed between the electrode and the at least one electrical conductor, wherein the filler layer comprises a non-conductive adhesive and a monolayer of electrically conductive rigid particles in the non-conductive adhesive, wherein the electrically conductive rigid particles are disposed between the electrode and the at least one electrical conductor and electrically connect the electrode to the at least one electrical conductor.

2. The ultrasonic applicator of claim 1, wherein: the electrically conductive rigid particles are configured to deliver electrical power between the at least one electrical conductor and the electrode of the at least one ultrasonic transducer.

3. The ultrasonic applicator of claim 1, wherein: a size or diameter of each of the electrically conductive rigid particles differs from an average size or an average diameter of the electrically conductive rigid particles by less than 10%.

4. The ultrasonic applicator of claim 1, wherein: the filler layer comprises an electrically conductive adhesive film comprising the electrically conductive rigid particles.

5. The ultrasonic applicator of claim 1, wherein: the electrically conductive rigid particles are shaped and sized to cause the at least one ultrasonic transducer to remain substantially parallel to the at least one electrical conductor.

6. The ultrasonic applicator of claim 1, wherein: the electrically conductive rigid particles are thermally conductive particles for conducting heat away from the at least one ultrasonic transducer through the filler layer.

7. The ultrasonic applicator of claim 1, wherein: the non-conductive adhesive comprises a cured adhesive material.

8. The ultrasonic applicator of claim 1, wherein: each of the electrically conductive rigid particles comprises a non-conductive core surrounded by an electrically conductive layer.

9. The ultrasonic applicator of claim 8, wherein: the non-conductive core comprises a non-conductive polymer or a mixture of polymers.

10. The ultrasonic applicator of claim 8, wherein: the electrically conductive layer surrounding the non-conductive core comprises a metallic material or a mixture of metallic materials, the metallic materials including at least one of copper, silver, and tungsten.

11. The ultrasonic applicator of claim 1, wherein: at least 25% of the electrically conductive rigid particles comprise a rigid core at least partially surrounded by a soft layer, the soft layer being softer relative to the rigid core.

12. The ultrasonic applicator of claim 11, wherein: the electrode is in contact with the soft layer.

13. The ultrasonic applicator of claim 1, wherein: at least 30% of a volume of the filler layer comprises the electrically conductive rigid particles.

14. The ultrasonic applicator of claim 1, wherein: the monolayer of the electrically conductive rigid particles in the non-conductive adhesive is formed by pressing the at least one ultrasonic transducer into the non-conductive adhesive towards the electrical conductor.

15. The ultrasonic applicator of claim 1, wherein: the at least one transducer comprises a PZT element made of a stiff material having a mechanical quality factor greater than 600.

16. The ultrasonic applicator of claim 1, wherein: the at least one ultrasonic transducer comprises a PZT element and a polyimide printed circuit board placed on top of the PZT element, wherein a thickness of the polyimide is in a range between 10 μιη and 35 μιη.

17. The ultrasonic applicator of any one of claims 1 to 16, wherein: a thickness of the monolayer of the electrically conductive rigid particles is in a range between 10 μιη and 300 μιη.

18. The ultrasonic applicator of claim 1, comprising: An applicator body having at least one ultrasonic emitting surface shaped and sized to contact a skin, and at least two spaced-apart ultrasonic transducers, wherein each of the at least two spaced-apart ultrasonic transducers includes a first surface facing the ultrasonic emitting surface of the applicator body, and a first electrode connected to the first surface of the ultrasonic transducer; An unpassivated electrical wiring configured to energize each of the at least two ultrasonic transducers, connected to the first electrode of each of the at least two spaced-apart ultrasonic transducers; An insulating coating fixedly attaching the unpassivated electrical wiring to the electrode, the insulating coating configured to seal the unpassivated electrical wiring and the at least two ultrasonic transducers from fluids and air.

19. The ultrasonic applicator of claim 18, wherein: The unpassivated electrical wiring is connected to the first electrode by soldering.

20. The ultrasonic applicator of claim 18, wherein: The ultrasonic applicator comprises: At least one additional flexible unpassivated electrical conductor connected to a plurality of thermistors, wherein the flexible unpassivated electrical conductor is bent to position the plurality of thermistors between the at least two spaced-apart ultrasonic transducers, and wherein the insulating coating electrically isolates the unpassivated electrical wiring and the flexible unpassivated electrical conductor to prevent shorting therebetween.

21. The ultrasonic applicator of claim 1, wherein: The at least one ultrasonic transducer includes a surface facing the ultrasonic emitting surface of the applicator body, wherein the applicator body further comprises an electrode connected to the surface of the ultrasonic transducer and an electrical wiring configured to energize the at least one ultrasonic transducer, wherein the electrical wiring is connected to the electrode by soldering.

22. The ultrasonic applicator of claim 21, wherein: A portion of the electrical wiring connected to the electrode comprises unpassivated electrical wiring.

23. A method for initiating the ultrasonic applicator of claim 1 to treat skin tissue as part of a cosmetic treatment, comprising: initiating the at least one ultrasonic transducer of the ultrasonic applicator by a console, the ultrasonic transducer configured to generate and deliver ultrasonic energy to cosmetically treat a plurality of skin tissue; identifying a decline in potential efficiency of the ultrasonic energy delivery during the initiating; and modifying the initiating according to the identified results.

24. The method of claim 23, wherein: The initiating comprises initiating the at least one ultrasonic transducer of the ultrasonic applicator intermittently at the same time for a period of at least 1 month to treat two or more subjects, and wherein the identifying comprises identifying the decline during the period.

25. The method of claim 23, wherein: The identifying comprises identifying variations in the potential efficiency of the ultrasonic delivery when treating different skin areas of a subject using the same ultrasonic transducer or the same group of ultrasonic transducers.

26. The method of claim 23, wherein: The method comprises receiving signals from one or more temperature sensors in the ultrasonic applicator, and wherein the identifying comprises identifying an increase in heat based on the received signals.

27. The method of claim 23, wherein: The method includes measuring a plurality of impedance values of the at least one ultrasound transducer, and wherein the identifying includes identifying the degradation in the potential efficiency of the ultrasound generation and / or delivery based on the measured plurality of impedance values.

28. The method of claim 23, wherein: The at least one ultrasound transducer includes two or more ultrasound transducers, wherein the identifying includes identifying a degradation in an efficiency of the conversion of electricity to ultrasound energy by at least one ultrasound transducer of the two or more ultrasound transducers, and wherein the modifying includes stopping the activation of the at least one ultrasound transducer while continuing the activation of at least one different ultrasound transducer of the two or more ultrasound transducers, or disabling the activation of the ultrasound transducer.

29. The method of claim 28, wherein: The modifying includes increasing an activation duration and / or power of the at least one activated ultrasound transducer to compensate for the stopped at least one ultrasound transducer.

30. The method of claim 23, wherein: The identifying includes identifying a degradation in an efficiency of the conversion of electricity to ultrasound energy by at least one ultrasound transducer, and wherein the method includes communicating an indication to a user to continue using the ultrasound applicator or to replace the ultrasound applicator by a plurality of instructions.

31. The method of claim 23, wherein: The method includes sending an alert signal and / or at least one log file to a remote device based on the identified degradation.

32. The method of claim 31, wherein: The identifying includes remotely modifying the activation of the at least one ultrasound transducer or an activation of the applicator using a signal from the remote device.

33. The method of any one of claims 23 to 32, wherein: The method includes: receiving an identifying indication associated with the ultrasound applicator prior to the activating; and wherein the activating includes activating the at least one ultrasound transducer if the received identifying indication is an authorized identifying indication.

34. An ultrasound system for treating skin tissue, comprising: a console including a control circuit, a memory, and at least one electrical circuit configured to energize one or more ultrasound transducers; the ultrasound applicator of claim 1 coupled to the console including at least one ultrasound transducer electrically connected to the at least one electrical circuit, wherein the at least one ultrasound transducer is configured to vibrate and generate ultrasound energy in response to the electrical circuit being energized; wherein, the control circuit is configured to: send signals to the electrical circuit to energize the at least one ultrasound transducer in accordance with indications stored in the memory; identify a degradation in a potential efficiency of the generation and / or delivery of the ultrasound energy to the skin tissue; and send signals to the electrical circuit to modify an activation of the at least one ultrasound transducer in accordance with the identified plurality of results.

35. The ultrasonic system of claim 34, wherein: the control circuit is configured to send signals to the electrical circuit to intermittently energize the at least one ultrasound transducer during a period of at least 30 days in accordance with indications stored in the memory.

36. The ultrasonic system of claim 34, wherein: the control circuit is configured to identify the degradation by measuring a plurality of impedance values or a plurality of changes in a plurality of impedance values of the at least one ultrasound transducer during the energization by the at least one electrical circuit.

37. The ultrasonic system of claim 34, wherein: The ultrasonic applicator includes one or more thermistors configured to sense temperature levels of the at least one ultrasonic transducer and / or proximate to the at least one ultrasonic transducer, and wherein the control circuit identifies the degradation based on signals received from the one or more thermistors.

38. The ultrasonic system of claim 34, wherein: The control circuit is configured to identify the degradation by identifying a degradation of the at least one ultrasonic transducer's conversion of electrical energy to ultrasonic energy.

39. The ultrasonic system of claim 34, wherein: The system includes a user interface configured to generate and communicate a human detectable indication to a user of the system, wherein the control circuit sends a signal to the user interface to generate and communicate the human detectable indication by way of instructions to replace the ultrasonic applicator.

40. The ultrasonic system of claim 34, wherein: The control console includes a communication circuit configured to generate and receive signals from a remote device, and wherein the control circuit sends a signal to the communication circuit to generate and send an indication signal to a remote device if the identified efficiency degradation is greater than a reference value indication stored in the memory.

41. The ultrasonic system of claim 40, wherein: The at least one ultrasonic applicator includes two or more ultrasonic transducers, and wherein the communication circuit receives a signal from the remote device to a user of the system by way of instructions to deactivate the ultrasonic applicator or at least one ultrasonic transducer of the two or more ultrasonic transducers in accordance with the results.

42. The ultrasonic system of any of claims 34 to 41, wherein: The applicator includes an identification tag, and wherein the control console includes an identification tag reader configured to read the identification tag and store at least one indication of the identification tag in the memory.

43. The ultrasonic system of claim 42, wherein: The control circuit is configured to determine whether the at least one identification tag indication is an authorized identification tag indication, and to activate or deactivate the at least one ultrasonic transducer in accordance with the results of the determination.

44. An ultrasonic system for ultrasonically treating skin tissue, comprising: The ultrasonic applicator of claim 1, wherein the at least one ultrasonic transducer comprises: two or more ultrasonic transducers configured to generate ultrasonic waves; wherein the ultrasonic applicator further comprises: an electrical wiring connected to the two or more ultrasonic transducers; a control console coupled to the ultrasonic applicator, the control console comprising: a memory for storing impedance value indications; a control circuit electrically connected to the electrical wiring, wherein the control circuit is configured to: activate the two or more ultrasonic transducers in accordance with indications stored in the memory; measure impedance values on each of the two or more ultrasonic transducers separately during variations in frequency of the ultrasonic waves; detect relative variations in measured impedance between the two or more ultrasonic transducers; modify activation of at least one ultrasonic transducer of the at least two ultrasonic transducers in response to the detected relative variations. The ultrasonic applicator of claim 1, wherein the at least one ultrasonic transducer comprises: two or more ultrasonic transducers configured to generate ultrasonic waves; wherein the ultrasonic applicator further comprises: an electrical wiring connected to the two or more ultrasonic transducers; a control console coupled to the ultrasonic applicator, the control console comprising: a memory for storing impedance value indications; a control circuit electrically connected to the electrical wiring, wherein the control circuit is configured to: activate the two or more ultrasonic transducers in accordance with indications stored in the memory; measure impedance values on each of the two or more ultrasonic transducers separately during variations in frequency of the ultrasonic waves; detect relative variations in measured impedance between the two or more ultrasonic transducers; modify activation of at least one ultrasonic transducer of the at least two ultrasonic transducers in response to the detected relative variations.

45. The ultrasonic system of claim 44, wherein: The control circuit determines a relationship between the plurality of impedance values of each ultrasonic transducer measured separately and a plurality of impedance reference values of a specific ultrasonic transducer stored in the memory.

46. The ultrasonic system of claim 44, wherein: The system comprises a user interface configured to generate a human detectable indication, and wherein the control circuit sends a signal to the user interface to generate the human detectable indication in accordance with the detected changes and / or if the activation of the at least one ultrasonic transducer is modified.

47. The ultrasonic system of claim 44, wherein: The control circuit is configured to stop an activation of at least one ultrasonic transducer if the plurality of impedance measurements of the at least one ultrasonic transducer differs from an average of the plurality of impedance measurements of the two or more ultrasonic transducers of the ultrasonic applicator by more than 5%.

48. The ultrasonic system of claim 44, wherein: The control circuit is configured to modify at least one activation parameter of at least one ultrasonic transducer if the plurality of impedance measurements of the at least one ultrasonic transducer differs from an average of the plurality of impedance measurements of the two or more ultrasonic transducers by more than 5%.

49. The ultrasonic system of claim 44, wherein: The control circuit is configured to modify at least one activation parameter of at least one ultrasonic transducer if the plurality of impedance measurements of the at least one ultrasonic transducer differs from an average of the plurality of impedance measurements of the two or more ultrasonic transducers by more than 5%.

50. The ultrasonic system of any one of claims 48 or 49, wherein: The at least one activation parameter comprises one of a group of parameters consisting of a group of parameters consisting of an activation duration, a driving voltage, an ultrasonic frequency, an acoustic intensity, a pre-cooling and a post-cooling time.

51. A method of activating an ultrasonic applicator during a cosmetic non-therapeutic treatment of the skin, comprising: placing an ultrasonic applicator according to claim 1 in contact with a skin surface, the ultrasonic applicator comprising at least two ultrasonic transducers; activating the at least two ultrasonic transducers according to a cosmetic treatment protocol; measuring a plurality of impedance values of the at least two ultrasonic transducers separately during the activation; detecting changes in the plurality of impedance values of at least one ultrasonic transducer relative to the plurality of impedance values of at least one different ultrasonic transducer when changing a plurality of frequency levels; modifying at least one parameter of the cosmetic treatment protocol in accordance with the detected changes. The control circuit is configured to stop an activation of at least one ultrasonic transducer if the plurality of impedance measurements of the at least one ultrasonic transducer differs from an average of the plurality of impedance measurements of the two or more ultrasonic transducers of the ultrasonic applicator by more than 5%. The control circuit is configured to modify at least one activation parameter of at least one ultrasonic transducer if the plurality of impedance measurements of the at least one ultrasonic transducer differs from an average of the plurality of impedance measurements of the two or more ultrasonic transducers by more than 5%. The control circuit is configured to modify at least one activation parameter of at least one ultrasonic transducer if the plurality of impedance measurements of the at least one ultrasonic transducer differs from an average of the plurality of impedance measurements of the two or more ultrasonic transducers by more than 5%. The at least one activation parameter comprises one of a group of parameters consisting of a group of parameters consisting of an activation duration, a driving voltage, an ultrasonic frequency, an acoustic intensity, a pre-cooling and a post-cooling time.

51. A method of activating an ultrasonic applicator during a cosmetic non-therapeutic treatment of the skin, comprising: placing an ultrasonic applicator according to claim 1 in contact with a skin surface, the ultrasonic applicator comprising at least two ultrasonic transducers; activating the at least two ultrasonic transducers according to a cosmetic treatment protocol; measuring a plurality of impedance values of the at least two ultrasonic transducers separately during the activation; detecting changes in the plurality of impedance values of at least one ultrasonic transducer relative to the plurality of impedance values of at least one different ultrasonic transducer when changing a plurality of frequency levels; modifying at least one parameter of the cosmetic treatment protocol in accordance with the detected changes.

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