Vector Tightening

Abstract

1. A method for producing directional skin tightening, comprising: providing at least one alignment indication for at least one energy-emitting transducer; aligning the at least one energy-emitting transducer with a surface of skin in accordance with the at least one alignment indication; applying energy by the at least one aligned energy-emitting transducer; and producing directional skin tightening by forming elongated, spaced-apart, thermally damaged lesions disposed in a deep tissue layer of the skin in accordance with the alignment of the at least one energy-emitting transducer.

Description

[Technical field]

[0001] Related Applications This application claims the benefit of priority under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 63 / 281,802, filed November 22, 2021, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] The present invention, in some embodiments thereof, relates to skin tightening, and more particularly, but not exclusively, to directional skin tightening.

[0003] Facelift surgery has evolved over the years from procedures aimed at lifting only the surface of the skin to procedures that target deeper tissue volumes for more permanent and natural results. Early facelift procedures were developed about 100 years ago and are commonly referred to as "skin-only lifts," which only target the skin and not the underlying tissue layers. A variation of this procedure, the "mini-lift," is still used in modern times. In general, the procedure consists of making an incision near the ear, detaching the lower facial skin from the underlying muscles of the lateral lower face, pulling the detached skin in a direction approximately perpendicular to the RSTL line, excising the excess skin, and finally suturing the skin edges. Summary of the Invention

[0004] The following describes some example embodiments of the invention; certain examples of the invention are described herein, and an embodiment may include features from multiple examples and / or less than all of the features of an example.

[0005] Example 1. A method for producing directional skin tightening, comprising: providing at least one alignment indication of at least one energy emitting transducer; aligning at least one energy emitting transducer with a surface of the skin according to said at least one alignment indicia; applying energy with the at least one aligned energy emitting transducer; causing directional skin tightening by forming elongated, spaced-apart, thermal damage lesions disposed in deep tissue layers of the skin in accordance with the alignment of the at least one energy-emitting transducer.

[0006] Example 2. Determining at least one desired skin tightening vector of the skin; and generating the at least one alignment representation according to the determined at least one skin tightening vector.

[0007] Example 3. The method of Example 2, wherein the aligning includes aligning the at least one energy emitting transducer on the skin surface to the determined at least one desired skin tightening vector using the at least one alignment indication, and repeating the irradiating at at least two locations on the skin surface located along the at least one determined skin tightening vector.

[0008] Example 4. The method of example 3, wherein the irradiating includes moving a skin-contacting surface of an ultrasound applicator including the at least one energy-emitting transducer between the two locations on the skin surface.

[0009] Example 5. The method of example 3 or 4, wherein the elongated, spaced-apart, thermally damaged lesions are axially positioned along the at least one determined skin tightening vector.

[0010] Example 6. A method as described in any one of Examples 2 to 5, wherein the determining includes determining the at least one desired skin tightening vector based on a position and / or orientation of at least one skin tension line on the skin surface.

[0011] Example 7. The method of example 6, wherein the determined at least one desired skin tightening vector is oriented at an angle of 45° to 135° relative to the at least one skin tension line at the skin surface.

[0012] Example 8. The method of example 7, wherein the at least one skin tension line comprises at least one of Langer's lines, Cox's lines, Kraissel's lines, Rubin's lines, Straith's lines, Bulacio's lines, and relaxed skin tension lines (RSTLs).

[0013] Example 9. A method as described in any one of Examples 2 to 8, wherein the determining includes determining the at least one desired skin tightening vector based on a position and / or orientation of at least one wrinkle on the skin surface.

[0014] Example 10. The method of example 9, wherein the determined at least one desired skin tightening vector is oriented at an angle of between 45° and 135° relative to the at least one wrinkle.

[0015] Example 11. The method according to any one of Examples 2 to 10, wherein the minimum distance between two adjacent elongated, spaced-apart, thermally damaged lesions along the at least one determined skin tension vector is in the range of 0.1 mm to 20 mm.

[0016] Example 12. A method as described in any one of Examples 2 to 11, comprising controlling the depth of irradiation depending on the depth and / or position of the nervous tissue along the determined at least one skin tightening vector.

[0017] Example 13. The method of any one of Examples 1 to 12, wherein the irradiating of the energy includes heating at least one tissue volume within the deep tissue layer of the skin to a temperature in the range of 50°C to 80°C to form at least one of the elongated, spaced apart, thermal damage lesions.

[0018] Example 14. The method of Example 13, wherein the at least one tissue volume comprises collagen fibers, and the irradiating comprises irradiating the energy at a parameter value sufficient to cause partial denaturation of the collagen fibers within the at least one tissue volume.

[0019] Example 15. The method of Example 14, wherein the irradiating includes irradiating the energy using at least one energy-emitting transducer having a major axis and a minor axis, and the irradiated energy produces contraction of collagen within the at least one tissue volume along the major axis of the at least one energy-emitting transducer.

[0020] Example 16. The method of example 15, wherein the ratio of collagen contraction along the major axis of the at least one energy-emitting transducer to collagen contraction along the minor axis of the at least one energy-emitting transducer is at least 1.5.

[0021] Example 17. The method of any one of Examples 14-16, wherein said irradiating comprises irradiating said deeper tissue layer with unfocused ultrasound energy.

[0022] Example 18. The method described in Example 17, wherein the unfocused ultrasound energy is applied at values ​​of unfocused ultrasound energy parameters sufficient to at least partially denature the collagen fibers within the at least one thermally damaged lesion, the unfocused ultrasound energy parameters including at least one of ultrasound frequency, ultrasound intensity, energy level per pulse of ultrasound energy delivered to the skin, and pulse duration.

[0023] Example 19. The method according to Example 18, wherein the frequency of the ultrasound is in the range of 5 MHz to 22 MHz.

[0024] Example 20. The intensity of the ultrasonic wave is 8 to 40 W / cm 2 The method according to Example 18 or 19, wherein the range is

[0025] Example 21. The method of any one of Examples 18-20, wherein the energy level per pulse of ultrasound is in the range of 2-5 Joules.

[0026] Example 22. The method of any one of Examples 18-21, wherein the duration of each pulse of ultrasonic energy ranges from 1 to 10 seconds.

[0027] Example 23. The method of any one of Examples 2-16, wherein the irradiating comprises irradiating the deeper tissue layers of the skin with focused ultrasound energy or radio frequency (RF) radiation.

[0028] Example 24. A method as described in any one of Examples 1 to 23, wherein the aligning includes aligning the at least one energy emitting transducer to a skin surface on the subject's face or neck.

[0029] Example 25. The method of any one of Examples 1 to 24, wherein the effecting includes effecting the directional skin tightening without incising the skin of the subject.

[0030] Example 26. The method of any one of Examples 1 to 25, wherein the irradiated energy creates a facelift or mini-facelift in the subject by forming the elongated, spaced, thermally damaged lesions.

[0031] Example 27. The method of Example 26, wherein the forming includes forming the facelift or mini-facelift without incising the subject's skin.

[0032] Example 28. The method of any one of Examples 1 to 27, comprising cooling the surface of the skin to a temperature of less than 20° C. during said irradiating.

[0033] Example 29. A method for producing directional skin tightening, comprising: placing at least one elongated energy-emitting transducer in contact with a skin surface of a target treatment area, the at least one elongated energy-emitting transducer including a major axis and a minor axis; applying energy to a deeper tissue layer of the skin, the deeper tissue layer including collagen, with the at least one energy emitting transducer; causing contraction of the collagen by the irradiated energy, wherein a ratio of collagen contraction along the major axis of the at least one energy emitting transducer to collagen contraction along the minor axis is at least 1.5.

[0034] Example 30. The method described in Example 29, wherein the deep tissue layer is located at a depth ranging from 0.5 mm to 5 mm from the skin surface.

[0035] Example 31. The method of Example 29 or 30, wherein the irradiating includes heating at least one tissue volume within the deep tissue layer containing the collagen to a temperature of 50 to 80°C by the irradiated energy.

[0036] Example 32. The method of any one of Examples 29-31, wherein the irradiating comprises irradiating the deeper tissue layers of the skin with focused ultrasound energy or radio frequency (RF) radiation.

[0037] Example 33. The method described in any one of Examples 29 to 31, wherein the irradiating includes irradiating the deeper tissue layers of the skin with unfocused ultrasound energy by delivering unfocused ultrasound through the skin surface.

[0038] Example 34. The method of example 33, wherein the frequency of the delivered unfocused ultrasound is in the range of 5 MHz to 22 MHz.

[0039] Example 35. The intensity of the delivered unfocused ultrasound is 8 to 40 W / cm 2 The method according to Example 33 or 34, wherein the range is

[0040] Example 36. The method of any one of Examples 33 to 35, wherein the energy level per pulse of the delivered unfocused ultrasound is in the range of 2 to 5 Joules.

[0041] Example 37. The method according to any one of Examples 33 to 36, wherein the duration of each pulse of unfocused ultrasound delivered ranges from 1 to 10 seconds.

[0042] Example 38. The method of any one of Examples 29 to 37, comprising cooling the skin surface in contact with the at least one elongated energy-emitting transducer to a temperature of less than 25°C during the irradiating.

[0043] Example 39. A skin tightening system comprising: an applicator including at least one energy emitting transducer configured to generate and deliver energy to skin tissue; a user interface configured to deliver a human-detectable indication to a user of the system; a control circuit operatively connected to the user interface; the control circuitry is configured to deliver at least one alignment indication of the at least one energy-emitting transducer via the user interface, and to signal the at least one energy-emitting transducer to generate and deliver the energy at parameter values ​​sufficient to cause directional skin tightening in at least one skin region.

[0044] Example 40. The system of Example 39, wherein the user interface comprises a display, and the control circuit signals the user interface to deliver the at least one alignment indication to the display.

[0045] Example 41. A system as described in Example 39 or 40, comprising a memory, the memory storing a representation of at least one desired skin tightening vector in the at least one skin area, and the at least one alignment representation including information regarding the representation of the at least one desired skin tightening vector.

[0046] Example 42. The system described in Example 41, wherein the indication of the at least one desired skin tightening vector stored in the memory includes positioning information for two or more treatment sites along the at least one desired skin tightening vector for positioning the applicator and for delivering the energy.

[0047] Example 43. The system described in Example 42, wherein the control circuit sends a signal to the user interface to generate a human-detectable display including information regarding the position and / or orientation of the applicator relative to one of the at least two treatment sites.

[0048] Example 44. The system described in Example 43, wherein the applicator is provided with at least one position and / or orientation sensor, and the user interface generates an indication detectable by the human based on a signal received from the at least one sensor.

[0049] Example 45. A system described in any one of Examples 39 to 44, wherein the energy emitting transducer includes at least one ultrasound transducer configured to deliver unfocused ultrasound energy to the skin, and the control circuit activates the ultrasound transducer according to values ​​of activation parameters sufficient to at least partially denature collagen fibers within at least one tissue volume within a deep tissue layer of the skin, the activation parameters including at least one of an ultrasound frequency, an ultrasound intensity, an energy level per pulse of ultrasound energy delivered to the skin, and a pulse duration.

[0050] Example 46. The system described in Example 45, wherein the value of the activation parameter is sufficient to cause contraction of the collagen fiber along a long axis of the collagen fiber that is at least two times greater than the contraction caused by the value of the activation parameter in a short axis of the collagen fiber.

[0051] Example 47. A system described in Example 45 or 46, wherein the ultrasonic frequency is in the range of 5 MHz to 22 MHz.

[0052] Example 48. The intensity of the ultrasonic wave is 8 to 40 W / cm 2 The system according to any one of Examples 45 to 47, wherein the range is

[0053] Example 49. A system described in any one of Examples 45 to 48, wherein the energy level per pulse of ultrasound is in the range of 2 to 5 joules.

[0054] Example 50. A system described in any one of Examples 45 to 49, wherein the duration of each pulse of ultrasonic energy is in the range of 1 to 10 seconds.

[0055] Example 51. A system described in any one of Examples 45 to 50, comprising a cooling module configured to cool the at least one ultrasonic transducer to a temperature less than 25°C during the activation of the at least one ultrasonic transducer by the control circuit.

[0056] Example 52. Use in a method to produce cosmetic non-therapeutic directional skin tightening, providing at least one alignment indicia of the at least one energy emitting transducer; aligning the at least one energy emitting transducer to a surface of the skin according to the at least one alignment indicia; applying energy with the at least one aligned energy emitting transducer; The system of Example 39, further comprising repeating the aligning and irradiating until cosmetically beneficial directional skin tightening occurs.

[0057] Example 53. A method for producing cosmetic non-therapeutic directional skin tightening comprising: providing at least one alignment indication of at least one energy emitting transducer; aligning at least one energy emitting transducer with a surface of the skin according to said at least one alignment indicia; applying energy with the at least one aligned energy emitting transducer; and repeating said aligning and said irradiating until cosmetically beneficial directional skin tightening occurs.

[0058] Example 54. Determining at least one desired skin tightening vector of the skin; and generating the at least one alignment indication according to the determined at least one skin tightening vector.

[0059] Example 55. The method described in Example 54, wherein the repeating includes repeating the aligning and the irradiating until cosmetically beneficial directional skin tightening occurs in the at least one desired skin tightening vector.

[0060] Example 56. The method described in Example 54 or 55, wherein the aligning includes aligning the at least one energy emitting transducer on the skin surface to the determined at least one desired skin tightening vector using the at least one alignment indication, and the repeating includes repeating the irradiating at at least two positions on the skin surface located along the at least one determined skin tightening vector.

[0061] Example 57. The method of Example 56, wherein the irradiating step includes moving a skin contact surface of an ultrasound applicator including the at least one energy emitting transducer between the two positions on the skin surface.

[0062] Example 58. The method described in Example 56 or 57, comprising forming elongated, spaced apart, thermal damage lesions in a deeper tissue layer of the skin arranged in accordance with the alignment of the at least one energy emitting transducer, wherein the cosmetically beneficial directional skin tightening results from said formation.

[0063] Example 59. The method of Example 58, wherein the elongated, spaced apart, thermally damaged lesions are axially positioned along the at least one determined skin tightening vector.

[0064] Example 60. A method described in any one of Examples 54 to 59, wherein the determining includes determining the at least one desired skin tightening vector based on the position and / or orientation of at least one skin tension line on the skin surface.

[0065] 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 this invention belongs. Although methods and materials similar or equivalent to those described herein may be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. Furthermore, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0066] As will be appreciated by those skilled in the art, some embodiments of the present invention may be embodied as a system, a method, or a computer program product. Accordingly, some embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, microcode, etc.), or an embodiment combining software and hardware aspects, which may be generally referred to herein as a "circuit," "module," or "system." Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied therein. Implementation of the methods and / or systems of some embodiments of the present invention may involve performing and / or completing selected tasks manually, automatically, or a combination thereof. Furthermore, depending on the actual instrumentation and implementation of some embodiments of the methods and / or systems of the present disclosure, some selected tasks could be implemented by hardware, software, or firmware, and / or a combination thereof, for example using an operating system.

[0067] For example, hardware for performing selected tasks according to some embodiments of the present invention may be implemented as a chip or circuit. As software, selected tasks according to some embodiments of the present invention may be implemented as a number of software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the present invention, one or more tasks according to exemplary embodiments of the methods and / or systems described herein are performed by a data processor, such as a computing platform for executing a number of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage, e.g., a magnetic hard disk and / or removable media, for storing instructions and / or data. Optionally, a network connection is also provided. A display and / or a user input device, such as a keyboard or mouse, are also optionally provided.

[0068] Some embodiments of the present invention may utilize any combination of one or more computer readable medium(s). The computer readable medium may be a computer readable signal medium or a computer readable storage medium. The computer readable storage medium may 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 of computer readable storage media would include an electrical connection with one or more communication lines, a portable computer diskette, a hard disk, a random access memory (RAM), a read only memory (ROM), an electrically erasable (EPROM or flash memory), an optical fiber, a compact disk 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 may 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.

[0069] A computer-readable signal medium may include a propagated data signal in which computer-readable program code is embodied, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including but not limited to electromagnetic, optical, or any combination thereof. A computer-readable signal medium is not a computer-readable storage medium but may be any computer-readable medium that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0070] Program code embodied on a computer readable storage medium and / or data used thereby may be transmitted using any suitable medium, including but not limited to wireless, wired, fiber optic cable, RF, etc., or any suitable combination of the above.

[0071] Computer program code for carrying out operations for some embodiments of the present invention may be written in any combination of one or more programming languages, including object-oriented programming languages, such as Java, Smalltalk, C++, and conventional procedural programming languages, such as the "C" programming language or similar. The program code may run entirely on the user's computer, partially on the user's computer as a stand-alone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computer (e.g., via the Internet using an Internet Service Provider).

[0072] Some embodiments of the present invention are described below with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present invention. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general purpose computer, a special purpose computer, or other programmable data processing apparatus to manufacture a machine, such that the instructions, executing via the processor of the computer or other programmable data processing apparatus, create means for performing the functions / acts specified in the flowchart and / or block diagram of a block or blocks.

[0073] These computer program instructions may also be stored on a computer-readable medium that can instruct a computer, other programmable data processing apparatus, or other device to function in a particular manner, such that the instructions stored on the computer-readable medium produce an article of manufacture that includes instructions implementing the functions / acts specified in the flowcharts and / or block diagrams of a block or blocks.

[0074] The computer program instructions may be loaded onto a computer, other programmable data processing apparatus, or other device to create a computer-implemented process such that the instructions executing on the computer or other programmable apparatus cause a series of operational steps to be executed by the computer or other programmable apparatus to provide a process for performing the functions / acts specified in the flowcharts and / or block diagrams of a block or blocks.

[0075] Some of the methods described herein are generally designed for computer use only and may not be suitable or practical for a human expert to perform entirely manually. A human expert wishing to manually perform similar tasks, such as planning tension vectors, locating skin tension lines, identifying treatment areas along the planned tension vectors, and identifying applicator positions relative to the planned tension vectors and / or at least one treatment area, may be expected to use entirely different methods, such as methods that utilize expert knowledge and / or the pattern recognition capabilities of the human brain, that would be much more efficient than performing the steps of the methods described herein manually.

[0076] Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings, in which: Reference will now be made specifically to the drawings in detail, stressing that the particulars shown are for the purpose of illustrating and discussing embodiments of the invention by way of example, and in this regard the description made with the drawings will make apparent to those skilled in the art how embodiments of the invention may be practiced. [Brief description of the drawings]

[0077] [Figure 1A] 1 is a flowchart of a process for producing skin tightening, according to some exemplary embodiments of the present invention. [Figure 1B] 1 is a schematic diagram of skin relaxation lines on the face and neck of a human subject, according to some exemplary embodiments of the present invention; [Diagram 2] 11 is a flowchart of a process for forming a tension vector along a selected direction, according to some exemplary embodiments of the present invention. [Diagram 3] 1A-C are schematic diagrams illustrating skin tightening in a direction angled relative to the skin relaxation line, according to some exemplary embodiments of the present invention. [Figure 4] 1A-C are schematic diagrams illustrating skin tightening relative to collagen fiber alignment after skin tightening treatment, according to some exemplary embodiments of the present invention. [Figure 5A] FIG. 1 is a block diagram of a system for delivery of directional skin tightening, according to some exemplary embodiments of the present invention. [Figure 5B] 1A-1C are schematic diagrams illustrating different arrangements of ultrasonic transducers on an applicator. [Figure 5C] 1A-1C are schematic diagrams illustrating different arrangements of ultrasonic transducers on an applicator. [Figure 6A] 11 is a flowchart illustrating actions taken by a user of a skin tightening system during the process of generating a directional tension vector, according to some exemplary embodiments of the present invention. [Figure 6B]10 is a flowchart illustrating operations performed by a skin tightening system during the process of generating a directional tension vector, according to some exemplary embodiments of the present invention. [Figure 7A] 1A-1C are schematic diagrams illustrating ultrasonic energy application patterns for creating directional collagen contraction and / or directional skin tightening using an elongated transducer, according to some exemplary embodiments of the present invention. [Figure 7B] 1A-1C are schematic diagrams illustrating ultrasonic energy application patterns for creating directional collagen contraction and / or directional skin tightening using an elongated transducer, according to some exemplary embodiments of the present invention. [Figure 7C] 1A-1C are schematic diagrams illustrating ultrasonic energy application patterns for creating directional collagen contraction and / or directional skin tightening using a non-elongated transducer, according to some exemplary embodiments of the present invention. [Figure 7D] 1A-1C are schematic diagrams illustrating ultrasonic energy application patterns for creating directional collagen contraction and / or directional skin tightening using a non-elongated transducer, according to some exemplary embodiments of the present invention. [Figure 8] 11A-11C are schematic diagrams illustrating generation of curved tension vectors, according to some exemplary embodiments of the present invention; [Figure 9] FIG. 1 is a schematic diagram of the 3D model geometry used in the simulation experiments. [Figure 10] The volume of denatured collagen between 3 and 5 Joules (J) is shown, and the curves represent the volume enclosed by isosurfaces of the same collagen denaturation rate, calculated using simulations. [Figure 11] Shown is a volume enclosed by 10% collagen denaturation (green), the simulation results were mirrored across two symmetry planes and copied seven times with a distance of 4 mm between two adjacent PZTs to replicate the design of the Sofwave handpiece, e.g., applicator. [Figure 12]FIG. 1 is a schematic diagram showing the line of maximum elongation (LME) and the line of relaxed skin tension (RSTL). [Figure 13] 1 is a graph showing changes in the length of rat tail tendons due to heat treatment at 58° C. Error bars represent the calculated standard deviation. [Figure 14] This is a graph showing the relationship between collagen contraction and heat dose, and the numbers in the black circles represent the remaining length after contraction. [Figure 15] The left panel shows the thermal dose in the dermis at 3.6 J, and the right panel shows the corresponding collagen deformation. [Figure 16] The left panel shows how the collagen deformation field ξ is integrated in one direction and plotted in a perpendicular plane. In this example, ξ is integrated in the y direction along the red arrow and plotted in the yellow hatched plane (xz plane). In the right panel, the projection results are shown in three perpendicular planes. [Figure 17] 1 is a graph showing collagen contractility in three orthogonal planes. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0078] The present invention, in some embodiments thereof, relates to skin tightening, and more particularly, but not exclusively, to directional skin tightening.

[0079] An aspect of some embodiments relates to forming at least one desired tension vector in the skin along a particular selected direction. In some embodiments, the tension vector is formed by creating a thermal damage lesion that is segmented in the selected direction. In some embodiments, the direction of the tension vector is a direction selected to produce a non-surgical facelift or a non-surgical mini-facelift on a subject, for example, without incising the subject's skin.

[0080] According to some embodiments, the selected direction is selected according to the position and / or orientation of wrinkles on the skin. Alternatively or additionally, the selected direction is selected according to the position and / or orientation of skin tension lines, e.g. relaxed skin tension lines (RSTLs). Alternatively or additionally, the selected direction is selected according to the position and / or orientation of collagen fibers in the skin.

[0081] According to some exemplary embodiments, forming thermal damage lesions in deeper tissue layers of the skin along the tension vectors optionally results in a skin tightening effect similar to the effect of a facelift or mini-facelift. As used herein, the term "along the tension vector" means that at least 50% of the thermal damage lesions are formed in a direction substantially parallel to and / or at the location of the tension vector.

[0082] According to some embodiments, the tension vector is formed by directing at least one energy-emitting transducer, for example a radio frequency (RF) transducer or an ultrasound transducer, along a selected direction. Optionally, the at least one energy-emitting transducer comprises an unfocused ultrasound transducer. In some embodiments, the at least one transducer comprises an elongated transducer or a transducer having an elongated energy-emitting surface. In some embodiments, the tension vector is formed by directing, for example aligning, a long axis of the transducer in the selected direction. Alternatively or additionally, the at least one energy-emitting transducer, for example an elongated or non-elongated transducer, is moved along the selected direction.

[0083] According to some embodiments, the tension vectors are formed as straight lines. Alternatively, the tension vectors are formed as jagged lines or curved lines. In some embodiments, the length and / or shape of the formed lines is based on at least one of the following: the type of skin tension line, the distance between two adjacent lines, the wrinkle density at the target location, the wrinkle depth at the target location, the skin tissue composition at the target location, and the presence and / or location of scar tissue at the target location.

[0084] According to some embodiments, at least one tension vector is formed in a selected global skin tightening direction similar to a selected global skin tightening direction for a facelift or mini facelift procedure. Alternatively or additionally, at least one tension vector is formed relative to one or more existing skin tension lines. Alternatively, at least one tension vector is formed locally to produce a localized skin tightening effect, for example to treat a specific wrinkle of the subject.

[0085] According to some embodiments, the skin tension lines include Langer's lines, Cox's lines, Kraissel's lines, Rubin's lines, Straith's lines, Bulacio's lines, and RSTL. In some embodiments, RSTL, also known as "Langer's lines", are shown in Figures 1A-1B, for example as line 102.

[0086] RSTL lines have the same directional shape in different people, but may vary slightly. Optionally, the RSTL lines may indicate collagen alignment, since they run parallel to the collagen's molecular orientation. Optionally, the skin's natural wrinkles lie along the RSTL lines, and can be used to identify their orientation.

[0087] According to some embodiments, energy, e.g., ultrasound energy, is applied to a deep tissue layer of the skin by one or more energy emitting transducers, e.g., ultrasound transducers. In some embodiments, energy is applied at a parameter value sufficient to heat a tissue volume of said deep tissue layer to a temperature in the range of 50° C. to 90° C., e.g., in the range of 50° C. to 80° C., in the range of 55° C. to 75° C., in the range of 65° C. to 85° C., or any intermediate, lesser or greater value. In some embodiments, energy is applied at a parameter value sufficient to heat a tissue volume of said deep tissue layer to a temperature in the range of 65° C. to 75° C. for a time period of 2 seconds to 5 seconds.

[0088] According to some embodiments, ultrasonic energy, such as unfocused ultrasonic energy, is applied by at least one ultrasonic transducer. In some embodiments, the ultrasonic energy is in the range of 8-40 W / cm. 2 range, e.g. 8~15W / cm 2 , 10~20W / cm 2 , 12~30W / cm 2 , or any intermediate, lower or higher value range of intensity values.

[0089] According to some embodiments, the frequency of the applied ultrasound is in the range of 5-22 MHz, for example 5-10 MHz, 5-15 MHz, 9-22 MHz, or any intermediate, smaller or larger value range.

[0090] According to some embodiments, the energy level per pulse of ultrasonic energy is in the range of 2-5 Joules, for example 2-4 Joules, 3-5 Joules, or any intermediate, smaller or larger value range.

[0091] According to some embodiments, the duration of each pulse of ultrasonic energy is in the range of 1 to 10 seconds, such as 1 to 4 seconds, 2 to 6 seconds, 3 to 6 seconds, 4 to 10 seconds, or any intermediate, smaller or larger value range.

[0092] According to some embodiments, the heated tissue volume includes collagen fibers, and the heating temperature and energy pulse duration (time) are sufficient to at least partially denature the collagen fibers. In some embodiments, the thermal dose delivered to the tissue to denature the collagen ranges from about 0.1 to about 10 according to the Arrhenius formula, for example, thermal doses in the ranges of 0.1-3, 0.1-5, 1-4, 2-6, 3-8, and 5-10 according to the Arrhenius formula. The thermal dose calculated using the Arrhenius formula takes into account the temperature of the tissue and the heating time. In some embodiments, to reach a thermal dose of 0.1-10, the energy level of the delivered ultrasound energy ranges from 3-5 Joules, as described above.

[0093] An aspect of some embodiments relates to producing directional skin tightening by producing directional collagen contraction. In some embodiments, the directional collagen contraction is produced by applying energy to a deep tissue layer of the skin that contains collagen. In some embodiments, the energy is applied at parameter values ​​sufficient to heat the collagen to a temperature level that at least partially denatures the collagen.

[0094] According to some embodiments, the energy is applied by at least one elongated energy-emitting transducer. In some embodiments, the elongated energy-emitting transducer has at least one major axis and at least one minor axis. In some embodiments, the contraction of collagen caused by the at least one transducer along the major axis of the transducer is greater than the contraction of collagen along the minor axis of the transducer. In some embodiments, the ratio of collagen contraction along the major axis of the transducer to collagen contraction along the minor axis of the transducer is at least 1.1, such as at least 1.2, at least 1.4, at least 1.5, at least 2, or any intermediate, smaller or larger ratio.

[0095] According to some exemplary embodiments, the directional collagen contraction is consistent with forming at least one desired tension vector of the skin. In some embodiments, the desired at least one tension vector is formed by forming a fractional area of ​​the directional collagen contraction region in the deep tissue layer of the skin along the desired skin tension vector. In some embodiments, the fractional area is formed by at least two spaced apart energy-emitting transducers of the applicator. Alternatively or additionally, the fractional area is formed by moving at least one energy-emitting transducer, for example an elongated energy-emitting transducer, along the desired tension vector.

[0096] According to some embodiments, energy is applied at parameter values ​​sufficient to heat the tissue volume of the deep tissue layer, including collagen, to a temperature in the range of 50° C. to 90° C., e.g., 50° C. to 80° C., 55° C. to 75° C., 65° C. to 85° C., or any intermediate, lesser or greater value. In some embodiments, energy is applied at parameter values ​​sufficient to heat the tissue volume of the deep tissue layer to a temperature in the range of 65° C. to 75° C. for a time period of 2 seconds to 5 seconds.

[0097] According to some embodiments, one or more of the methods described herein (e.g., FIG. 1A, FIG. 2, FIG. 6A, FIG. 6B) are used to produce cosmetically beneficial directional skin tightening, e.g., directional skin tightening in a desired or planned direction, with a desired or planned skin tightening level, and / or directional skin tightening that allows for obtaining a desired or planned skin appearance. In some embodiments, one or more of the systems described herein (e.g., FIG. 4A and FIG. 5A) are used in a method of producing cosmetically beneficial directional skin tightening. In some embodiments, the methods described herein are cosmetic non-therapeutic methods that have an effect limited to a skin layer of the body, e.g., an effect limited to a skin layer between the skin surface and subcutaneous tissue, e.g., an effect limited to the epidermal and / or dermal skin layers.

[0098] In some embodiments, the one or more transducers of the applicator indirectly contact the skin surface, for example, through at least one of a film, coating, gel, or any layer disposed between the one or more ultrasound transducers and the skin surface.

[0099] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0100] Exemplary Processes for Producing Skin Tightening According to some exemplary embodiments, skin tightening is induced using at least one energy-emitting transducer, such as an ultrasound transducer or a radio frequency (RF) electrode. In some embodiments, the ultrasound transducer includes an ultrasound transducer configured to generate unfocused, e.g., non-focused, ultrasound waves. In some embodiments, skin tightening is induced along at least one desired skin tightening vector by energy irradiated through the skin surface to the deeper tissue layers. Additionally or optionally, skin tightening is induced due to collagen contraction in the deeper tissue layers of the skin that is heated by the irradiated energy.

[0101] Reference is now made to FIG. 1, which illustrates a process for producing directional skin tightening, according to some exemplary embodiments of the present invention.

[0102] According to some exemplary embodiments, at least one alignment indicia is provided at block 102. In some embodiments, the at least one alignment indicia includes indicia for alignment of at least one energy emitting transducer, e.g., an ultrasound transducer, on the skin surface. Alternatively or additionally, the at least one alignment indicia includes indicia for alignment of an applicator, including an energy emitting transducer, e.g., an ultrasound transducer, on the skin surface. As a non-limiting example, in some embodiments, the alignment indicia includes at least one marking on the applicator, e.g., an elongated shape printed or molded on the applicator, an applicator part line, or an applicator side.

[0103] According to some exemplary embodiments, the at least one alignment indication is based on a desired skin tension vector. In some embodiments, the desired skin tension vector is determined according to at least one wrinkle on the skin and / or according to existing skin tension lines. In some embodiments, the skin tension lines include Langer's lines, Cox's lines, Kraissel's lines, Rubin's lines, Straith's lines, Bulacio's lines, and RSTL, such as the line 120 shown in FIG. 1B. Alternatively or additionally, the desired skin tension vector is determined according to the type and / or location of a cosmetic procedure, such as a facelift of a mini facelift, performed without incising the skin and using at least one method and / or system described herein.

[0104] According to some exemplary embodiments, the at least one alignment indication comprises a human detectable indication provided as a visual indication and / or an audio indication.

[0105] According to some exemplary embodiments, at least one energy emitting transducer is placed in contact with the skin surface and aligned according to the alignment indicia in block 104. Alternatively or additionally, an applicator including the at least one energy emitting transducer is aligned on the skin surface according to the provided alignment indicia.

[0106] According to some exemplary embodiments, energy is applied by an energy emitting transducer at block 106. In some embodiments, the applied energy comprises unfocused ultrasound energy. In some embodiments, the energy is applied percutaneously to at least one tissue volume located in a deep tissue layer of the skin, for example at least one tissue volume located at a depth of 0.5 mm to 5 mm from the skin surface. In some embodiments, the at least one tissue volume comprises collagen, optionally arranged as elongated fibers.

[0107] According to some exemplary embodiments, the applied energy heats at least one tissue volume to a temperature in the range of 50-80° C., e.g., 50-60° C., 55-70° C., 60-75° C., 60-80° C., or any intermediate, lower or higher temperature. In some embodiments, before, during, and / or after the application of the energy, the surface of the skin, e.g., the skin surface in contact with the at least one energy-emitting transducer, is cooled, optionally via the at least one energy-emitting transducer. In some embodiments, the skin surface is cooled to a temperature below 25° C., e.g., below 22° C., below 20° C., or any intermediate, lower or higher temperature.

[0108] According to some exemplary embodiments, the irradiated energy generates thermal damage lesions, e.g., segmented thermal damage lesions in deep tissue layers of the skin. Optionally, the thermal damage lesions are elongated lesions. In some embodiments, the thermal damage lesions are spaced lesions. In some embodiments, the segmented thermal damage lesions are located at a depth ranging from 0.5 to 5 mm, e.g., 0.5 to 2 mm, 1 to 4 mm, 2 to 5 mm, or any intermediate, smaller or larger value, from the epidermis or surface of the skin. In some embodiments, the thermal damage lesions are positioned and / or oriented, e.g., relative to each other, according to the alignment of at least one energy-emitting transducer, e.g., at least one ultrasound transducer.

[0109] In some embodiments, the distance between two adjacent thermally damaged lesions is in the range of 0.1 mm to 5 mm, for example, 0.1 mm to 0.5 mm, 0.2 mm to 1 mm, 0.5 mm to 2 mm, 1 mm to 3 mm, 2 mm to 5 mm, or any intermediate, smaller or larger value. In some embodiments, the fractionated thermally damaged lesions contain denatured collagen fibers. In some embodiments, the denaturation rate of collagen fibers in the thermally damaged lesions is in the range of 2% to 60%, for example, 2% to 10%, 5% to 30%, 15% to 50%, 20% to 55%, or any intermediate, smaller or larger value. According to some exemplary embodiments, the energy is applied intermittently at block 106. In some embodiments, the energy is applied to two or more locations on the skin surface located on at least one desired skin tension vector. In some embodiments, at least one energy emitting transducer is moved between two or more positions during the application of energy, for example, moved between two or more positions when the application of energy stops after application of energy at a first position and before starting application of energy at a second of the two or more positions.

[0110] According to some exemplary embodiments, the applied energy optionally contracts collagen in the at least one tissue volume at block 108. In some embodiments, the applied energy at least partially denatures collagen in the at least one tissue volume. In some embodiments, the at least one energy emitting transducer has at least one major axis and at least one minor axis. In some embodiments, the ratio of collagen contraction along at least one major axis of the transducer to collagen contraction along at least one minor axis of the transducer is at least 1.5, such as at least 2, at least 2.5, at least 3, or any intermediate, smaller or larger value.

[0111] According to some exemplary embodiments, skin tightening occurs at block 110. In some embodiments, skin tightening occurs without incising the skin. In some embodiments, skin tightening occurs in the facial and / or neck area. In some embodiments, skin tightening occurs by collagen contraction in the deeper tissue layers of the skin.

[0112] Exemplary Process for Forming Tension Vectors According to some exemplary embodiments, during the process of skin tightening, skin tension vectors are formed in skin tissue. In some embodiments, the skin tension vectors are formed in target areas of facial skin, for example as part of a cosmetic treatment. In some embodiments, the cosmetic treatment is a facelift treatment, including a full facelift, a partial facelift, and a mini facelift. Alternatively or additionally, the cosmetic treatment includes a treatment to minimize the appearance of wrinkles and / or scars. In some embodiments, the skin tension vectors are generated along a selected direction in the skin. Reference is now made to FIG. 2, which illustrates a process of generating skin tension vectors, according to some exemplary embodiments of the present invention.

[0113] According to some exemplary embodiments, optionally, a type of existing skin tension line is selected at block 200. In some embodiments, the type of existing skin tension line includes at least one of Langer's lines, Cox's lines, Kraissel's lines, Rubin's lines, Straith's lines, Bulacio's lines, and RSTL. In some embodiments, the type of existing skin tension line is selected based on the location of the skin area targeted for skin tightening treatment.

[0114] According to some exemplary embodiments, a desired direction, e.g., a target direction, of the skin tension vector is selected at block 202. In some embodiments, the desired direction is selected within the target skin area. In some embodiments, the desired direction is selected based on at least one of a location, orientation, and density of wrinkles in and / or near the target skin area. Alternatively or additionally, the desired direction is selected according to existing skin tension lines, e.g., existing skin tension lines in and / or near the target skin area.

[0115] Alternatively or additionally, the desired direction is selected according to at least one of skin composition, location of nerve tissue, location of blood vessels, and / or location of scar tissue in the target skin area. Optionally, the direction of the skin tension vector is selected to avoid and not pass through scar tissue.

[0116] According to some exemplary embodiments, selecting a direction in block 202 optionally includes determining a direction such as an angle between a skin tension vector and one or more wrinkles and / or an angle between a skin tension vector and an existing skin tension line of the skin tension line type selected in block 200.

[0117] According to some exemplary embodiments, selecting a direction in block 202 optionally includes determining a shape and / or length of a skin tension vector. In some embodiments, the shape and / or length of the skin tension vector is determined based on the location and / or shape of wrinkles in the target skin region. Alternatively or additionally, the shape and / or length of the skin tension vector is determined based on existing skin tissue lines. Alternatively or additionally, the shape and / or length of the skin tension vector is determined based on skin tissue composition, for example, based on the location of scar tissue in the target skin region.

[0118] According to some exemplary embodiments, energy is applied to the target skin area at block 204. In some embodiments, the applied energy includes RF energy and / or ultrasound energy. In some embodiments, the ultrasound energy includes focused ultrasound energy and / or unfocused ultrasound energy. In some embodiments, the energy is applied to the skin tissue, for example, as described in application WO2017 / 212489, filed June 6, 2017. Optionally, the energy is applied to the tissue while cooling the external surface of the skin.

[0119] According to some exemplary embodiments, the irradiated energy creates a fractionated thermal damage lesion in the skin in a selected direction at block 206. In some embodiments, the fractionated thermal damage lesion is located at a depth ranging from 0.5 to 5 mm, such as 0.5 to 2 mm, 1 to 4 mm, 2 to 5 mm, or any intermediate value, smaller or larger value, from the epidermis or surface of the skin. In some embodiments, the distance between two adjacent thermal damage lesions is in the range of 0.1 mm to 5 mm, such as 0.1 mm to 0.5 mm, 0.2 mm to 1 mm, 0.5 mm to 2 mm, 1 mm to 3 mm, 2 mm to 5 mm, or any intermediate value, smaller or larger value. In some embodiments, the fractionated thermal damage lesion comprises denatured collagen fibers. In some embodiments, the denaturation rate of collagen fibers in the thermal damage lesion is in the range of 2% to 60%, such as 2% to 10%, 5% to 30%, 15% to 50%, 20% to 55%, or any intermediate value, smaller or larger value.

[0120] According to some exemplary embodiments, at block 208, tension vectors are formed in a selected direction. In some embodiments, the tension vectors are formed, for example, by instantaneous contraction of collagen fibers and / or healing of fractionated heat damaged lesions. In some embodiments, the tension vectors are formed in a direction that reduces the appearance of wrinkles, for example, flattening and / or smoothing the skin surface. In some embodiments, the tension vectors are formed in a direction that is oblique or substantially perpendicular to existing wrinkles and / or existing skin tension lines.

[0121] Exemplary effects on organizations According to some exemplary embodiments, creating spaced thermal damage lesions in deeper layers of the skin results in skin tightening, for example tightening the outer surface of the skin, or as another example tightening the deeper dermal layers. In some embodiments, controlling the direction of creating the thermal damage lesions allows, for example, directing the skin tightening along a desired direction. In some embodiments, creating thermal damage lesions in an oblique or substantially perpendicular direction to existing wrinkles and / or existing skin tension lines results in a smooth skin surface. As used herein, "substantially perpendicular" means at an angle between 80 degrees and 100 degrees. Optionally, creating thermal damage lesions in an oblique or substantially perpendicular direction to existing wrinkles and / or existing skin tension lines reduces the appearance of wrinkles, for example to an extent similar to the effect of a facelift procedure.

[0122] Reference is now made to Figures 3A-3C, which illustrate a directional skin tightening effect through directional formation of thermal damage lesions, according to certain exemplary embodiments of the present invention.

[0123] According to some exemplary embodiments, as shown, for example, in Figure 3A, energy emitted by one or more energy emitting transducers, e.g., ultrasound transducers, creates thermal damage lesions in the skin, e.g., lesions 302, 304, 306, and 308. In some embodiments, lesions 302, 304, 306, and 308 are formed at a depth ranging from 0.5-5 mm below the epidermal layer of the skin or the surface of the skin, e.g., 0.5-2 mm, 1-4 mm, 2-5 mm, or any intermediate, lesser or greater value.

[0124] According to some exemplary embodiments, the lesions 302, 304, 306, and 308 are formed in a direction 310 that is at an angle 312 relative to at least one of the existing skin tension lines 314, 316, and 318. In some embodiments, the angle 312 is about 90 degrees. In some embodiments, the angle 312 is at least 45 degrees, such as at least 50 degrees, at least 70 degrees, at least 80 degrees, or any intermediate, smaller, or larger angle, relative to at least one of the existing skin tension lines 314, 316, and 318. Optionally, the direction 310 is substantially perpendicular to at least one of the existing skin tension lesions 314, 316, and 318.

[0125] According to some exemplary embodiments, lesions are formed along selected skin tension vectors, for example as shown in FIG. 2. In some embodiments, lesions 302, 304, 306, and 308 are formed along selected, e.g., predetermined, skin tension vectors 320, 322, 324, and 326, respectively. In some embodiments, at least one of skin tension vectors 320, 322, 324, and 326 is selected to be at an angle with respect to at least one of existing skin tension lines 314, 316, and 318, for example as described above with respect to angle 312 between direction 310 and the existing skin tension line. In some embodiments, two or more lesions along selected skin tension vectors are aligned with respect to each other. Alternatively, lesions along selected skin tension vectors are positioned at an angle with respect to each other, for example, lesions 328 and 330 are formed along selected skin tension vector 332. In some embodiments, the lesions along the selected skin tension vector are positioned at an angle of at least 45 degrees relative to one another, e.g., at least 50 degrees, at least 70 degrees, at least 80 degrees, or any intermediate, smaller, or larger angle.

[0126] According to some exemplary embodiments, the distance 323 between adjacent lesions, e.g., lesions 307 and 308, formed along a selected skin tension vector is in the range of 0.1 mm to 5 mm, e.g., 0.1 mm to 0.5 mm, 0.2 mm to 1 mm, 0.5 mm to 2 mm, 1 mm to 3 mm, 2 mm to 5 mm, or any intermediate, smaller, or larger value.

[0127] According to some exemplary embodiments, during the healing process of the lesion, collagen and / or elastin fibers are generated within the lesion, which results in increased skin contraction, e.g., as compared to a pre-treatment state, as shown in Figure 3B. In some embodiments, increasing skin contraction along a desired, optionally selected skin tension vector results in skin tightening along the skin tension vector, as shown in Figure 3C. In some embodiments, while collagen and / or elastin fibers are formed deep within the skin tissue, skin tightening appears at the skin surface, e.g., as a bending of existing skin tension lines.

[0128] Reference is now made to FIG. 4A, which depicts skin tightening on existing aligned collagen fibers, according to some exemplary embodiments of the present invention.

[0129] According to some exemplary embodiments, an applicator, e.g., ultrasonic applicator 402, includes at least one, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, or any number of more energy-transmitting transducers, e.g., ultrasonic transducers 404 and 406. In some embodiments, ultrasonic transducer 404 is an elongated transducer, e.g., having a major axis and a minor axis. Optionally, the ultrasonic transducer has an elongated energy emission surface, e.g., an energy emission surface having a major axis and a minor axis. Alternatively, the ultrasonic transducer is a non-elongated transducer and / or has a non-elongated energy emission surface.

[0130] According to some exemplary embodiments, at least one transducer, e.g., ultrasound transducers 404 and 406, emit energy, e.g., ultrasound energy 408, into skin tissue 410. In some embodiments, ultrasound transducers 404 and 406 emit ultrasound energy to generate at least one elongated thermal damage lesion, e.g., in a deep layer of skin tissue 410. In some embodiments, at least one elongated thermal damage lesion, e.g., a lesion 412 having a major axis and a minor axis, is generated by at least one elongated transducer or by a transducer having an elongated energy emitting surface. Alternatively or additionally, lesion 412 is generated by moving applicator 402 in direction 414.

[0131] According to some exemplary embodiments, elongated thermal damage lesions 412 are formed obliquely to the elongated axis of the collagen fibers, e.g., axis 416 of collagen fiber 418. Optionally, lesions 412 are substantially perpendicular to axis 416. In some embodiments, applicator 402 moves in direction 414 and is actuated intermittently to create a series of spaced apart thermal damage lesions, e.g., lesions 420 and 422, separated by, e.g., undamaged tissue or undamaged tissue at the same level as the tissue of lesions 420 and 422. In some embodiments, a series of spaced apart thermal damage lesions are aligned along a selected skin tension vector 426.

[0132] According to some exemplary embodiments, for example as shown in FIG. 4C, during the healing process, collagen and / or elastin grows within spaced apart lesions 420 and 422, causing contraction, for example along a selected skin tension vector 426.

[0133] Example System Reference is now made to Figures 5A-5C, which illustrate a system for delivering skin treatment, eg, cosmetic skin treatment, according to some exemplary embodiments of the present invention.

[0134] According to some exemplary embodiments, a system for delivering a skin treatment, such as system 502, comprises a control unit 504 and an ultrasound applicator 506 operatively coupled to the control unit 504. In some embodiments, the system 502 is configured to perform a skin tightening treatment, such as a directional skin tightening treatment. In some embodiments, the system 502 is similar to or includes one or more components of the ultrasound system described in International Patent Application Publication No. WO2017212489A2.

[0135] According to some exemplary embodiments, the ultrasound applicator 506 includes at least one, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, or any number of more ultrasound transducers, e.g., ultrasound transducers 508. In some embodiments, at least some of the ultrasound transducers 508 are elongated ultrasound transducers having a major axis and a minor axis. Optionally, at least some of the ultrasound transducers 508 comprise elongated energy emitting surfaces having a major axis and a minor axis. In some embodiments, the ultrasound transducers are positioned adjacent to one another within the applicator, and optionally, the major axes of all the transducers 508 are parallel.

[0136] According to some exemplary embodiments, each ultrasonic transducer of transducer 508 is an elongated ultrasonic transducer, optionally shaped in a rectangular shape. In some embodiments, the ultrasonic transducer has at least one major axis and at least one minor axis. In some embodiments, the size of each ultrasonic transducer, or the size of the energy emitting surface of the transducer, ranges from 1 mm×1.1 mm to 1 mm×10 mm, such as 1 mm×3 mm, 1 mm×5 mm, 1 mm×6 mm, or any intermediate, smaller or larger value.

[0137] According to some exemplary embodiments, the ultrasound transducers are arranged side-by-side within the applicator 506 in at least one row. Optionally, the ultrasound transducers are arranged side-by-side within the applicator in two or more spaced apart rows, optionally parallel to one another. Optionally, the rows are distributed in a direction parallel to the longitudinal axis of at least some of the ultrasound transducers 508. In some embodiments, each of the ultrasound transducers is configured to emit unfocused energy 510 or focused ultrasound energy into skin tissue of the patient 512, for example as described in International Patent Application Publication No. WO2017212489A2.

[0138] According to some exemplary embodiments, the control unit 504 includes a memory 514 for storing values ​​of activation parameters of the ultrasound transducer and / or at least one treatment program. In some embodiments, the at least one treatment program is a planned treatment program personalized for a particular subject, e.g., a patient. In some embodiments, the at least one treatment protocol includes information on the position of existing skin tension lines and / or the position of at least one selected skin tension vector. Optionally, the memory includes information on the position of existing skin tension lines and / or at least one selected skin tension vector, personalized for a particular subject, e.g., relative to a coordinate system or landmarks of the subject.

[0139] According to some exemplary embodiments, the control unit 504 includes a control circuit 516 operatively connected to the memory 514 and the ultrasound transducer 508. In some embodiments, the control circuit 516 is configured to activate the ultrasound transducer according to values ​​of activation parameters stored in the memory 514 or according to at least one treatment program stored in the memory 514.

[0140] According to some exemplary embodiments, the applicator 506 comprises at least one orientation and / or position sensor 518 operatively coupled to the control circuitry 516. In some embodiments, the at least one sensor 518 includes a gyroscope and / or an accelerometer. In some embodiments, the control circuitry 516 is configured to determine a position and / or orientation of the ultrasound applicator 506 relative to at least one of the patient's anatomical landmarks, the coordinate system applied to the patient 512, the patient's at least one existing skin tension line, and the selected at least one skin tension vector based on signals received from the at least one sensor 518. Alternatively or additionally, the control circuitry 516 is configured to determine a position and / or orientation of one or more of the ultrasound transducer 508 and / or ultrasound transducers relative to at least one of the patient's anatomical landmarks, the coordinate system applied to the patient 512, the patient's at least one existing skin tension line, and the selected at least one skin tension vector based on signals received from the at least one sensor 518.

[0141] According to some exemplary embodiments, the control circuitry 516 processes signals received from at least one sensor 518, optionally with an alignment module 520, to determine whether the ultrasound applicator 506 and / or transducer 508 are in a target position and / or orientation of a stored treatment program. In some embodiments, the control circuitry 516 optionally uses the alignment module 520 to determine a relationship between the signals received from the sensor 518 and a treatment program stored in the memory 514.

[0142] According to some exemplary embodiments, the control unit 504 includes a user interface, such as user interface 522, operatively connected to the control circuitry 516. In some embodiments, the user interface 522 is configured to generate and deliver a human-detectable indication, such as an audio signal and / or a visual signal. In some embodiments, the user interface 522 includes a display and / or at least one speaker.

[0143] According to some exemplary embodiments, the control circuitry 516 signals the user interface 522 to generate and deliver a human-detectable indication according to the determined position and / or orientation of the ultrasound applicator or transducer relative to the target position and / or orientation in the stored treatment program. In some embodiments, a first human-detectable indication is generated and delivered by the user interface 522 if the determined position and / or orientation is in accordance with the target position and / or orientation of the stored treatment program. Additionally, the user interface 522 generates and delivers a second human-detectable indication if the determined position and / or orientation does not match the target position and / or orientation of the stored treatment program. Optionally, the user interface 522 generates and delivers instructions to the user of the system 502 on how to move and / or rotate the applicator 506 to reach the target position and orientation. Alternatively or additionally, the user interface 522 generates and delivers instructions to a user of the system 502 on how to move and / or rotate the transducer 508 to reach a target position and orientation.

[0144] According to some exemplary embodiments, the system 502 optionally comprises a marker 524 operatively connected to the control circuitry 516, the marker 524 configured to mark pre-defined, e.g., planned or selected, skin tension vectors on the skin of the patient 512. In some embodiments, the marker comprises one or more LEDs or lasers configured to optically mark pre-defined skin tension vectors on the body, e.g., face and / or neck, of the patient 512.

[0145] Additionally or alternatively, the marker 524 is configured to mark a location within the skin where energy, e.g., ultrasound energy, was delivered. In some embodiments, the marker 524 is part of the applicator 506 and optionally includes a non-permanent, e.g., erasable, ink for marking the subject's skin.

[0146] According to some exemplary embodiments, the system 502 optionally includes or is operatively connected to a printer 526. In some embodiments, the printer 526 is configured to print markings, such as markings indicating a predetermined skin tension vector, on a mask, for example a gel mask. Optionally, the printer 526 is configured to generate a mask. In some embodiments, the gel mask comprises a face mask shaped and sized to be placed on the subject's face and to indicate the predetermined skin tension vector to a user of the device. In some embodiments, the printer 526 is used to generate a gel mask personalized for a particular patient and / or a particular treatment program.

[0147] According to some exemplary embodiments, the system 502 comprises a cooling module 528 in the control unit 504 operatively coupled to the applicator 506, for example as described in International Patent Application Publication No. WO2017212489A2. In some embodiments, the cooling module 528 is configured to apply cool air to a surface of the skin via a skin contacting surface of the applicator 506, for example via the ultrasonic transducer 508. In some embodiments, the cooling module 528 is configured to apply cool air, for example by optionally cooling the ultrasonic transducer. In some embodiments, the cooling module 528 is configured to apply cool air through the applicator 506 while emitting ultrasonic energy into the skin tissue, for example to prevent damage to the skin surface contacting the applicator during emission of ultrasonic energy. In some embodiments, the system 502 cools the ultrasonic transducer 508 and / or the surface of the skin contacting the applicator 506, for example as described in International Patent Application Publication No. WO2017212489A2.

[0148] According to some exemplary embodiments, the applicator includes at least one thermoelectric cooler (TEC) operatively coupled to the cooling module 528 and the ultrasonic transducer 508 and configured to cool at least a portion of the ultrasonic transducer, for example as described in International Patent Application Publication No. WO2017212489A2.

[0149] According to some exemplary embodiments, the applicator 506 includes at least one alignment mark configured to indicate the orientation of the ultrasound transducer, e.g., the relative orientation of the ultrasound transducer. In some embodiments, the at least one alignment mark is a visual mark located within the field of view (FOV) of a user holding the applicator. In some embodiments, the visual marking allows a user to determine the orientation of an ultrasound transducer that is outside the user's FOV, e.g., on or near the skin-contacting surface of the applicator.

[0150] According to some exemplary embodiments, the applicator 506 includes at least one user interface 521 operatively coupled to the control circuitry 516. In some embodiments, the user interface is configured to deliver one or more human-detectable indications, such as, for example, audio and / or visual indications, to a user holding the applicator 506. In some embodiments, the user interface 521 includes at least one light-emitting diode (LED) and / or at least one speaker for delivering the human-detectable indications. Alternatively or additionally, the user interface 521 includes at least one user input receiver, such as at least one button, configured to receive at least one input signal from a user holding the applicator. In some embodiments, the at least one user input signal includes an activation signal.

[0151] According to some exemplary embodiments, the housing of the applicator 506 is at least partially transparent, e.g., to allow a user holding the applicator 506 to visualize the contact point between the ultrasound transducer and the skin and / or one or more markings on the skin.

[0152] Exemplary Transducer Arrangements Reference is now made to Figures 5B and 5C, which illustrate different transducer arrangements on the emission surface of the applicator, according to some exemplary embodiments of the present invention.

[0153] According to some exemplary embodiments, a plurality of ultrasonic transducers, e.g., transducers 530 and 532, are arranged in one or more rows on or near the emitting surface of applicator 534. Optionally, the transducers are elongated transducers having a major axis 538 and a minor axis 537. In some embodiments, the ultrasonic transducers in a row, e.g., transducers 530 and 532, are arranged side-by-side, optionally with the major axis 538 of each transducer parallel to the other transducers in the row. In some embodiments, the ultrasonic transducers in a row or rows include 3, 4, 5, 6, 7, 8, 9, or any number less or greater than this. In some embodiments, the distance between adjacent transducers in a row, e.g., transducers 532 and 536, is in the range of 0.5 mm to 3 mm, e.g., 0.5 mm to 1 mm, 0.7 mm to 2 mm, 1.5 mm to 3 mm, or any intermediate, smaller, or larger distance. In some embodiments, the distance between two adjacent transducers in different rows, e.g., transducers 530 and 532, is in the range of 0.5 mm to 3 mm, e.g., 0.5 mm to 1 mm, 0.7 mm to 2 mm, 1.5 mm to 3 mm, or any intermediate distance, smaller or larger.

[0154] According to some exemplary embodiments, the length 540 of each transducer ranges from 1 mm to 10 mm, e.g., 1 mm to 5 mm, 2 mm to 7 mm, 4 mm to 8 mm, 6 mm to 10 mm, or any intermediate, smaller, or larger value. In some embodiments, the width 542 of each transducer ranges from 0.1 mm to 5 mm, e.g., 0.1 mm to 2 mm, 1 mm to 4 mm, 2 mm to 5 mm, or any intermediate, smaller, or larger value.

[0155] According to some exemplary embodiments, as shown in, for example, FIG 5C, some of the ultrasound transducers of applicator 533, e.g., transducers 544 and 546 in the same row, are tilted at angles ranging from 2 degrees to 90 degrees, e.g., 10 degrees to 50 degrees, 30 degrees to 60 degrees, or any intermediate, lesser, or greater value. Optionally, transducers in different rows, e.g., transducers 548 and 550, are tilted relative to each other at angles between 10 degrees to 50 degrees, 30 degrees to 60 degrees, or any intermediate, lesser, or greater value.

[0156] Exemplary Skin Tightening Treatments According to some exemplary embodiments, a subject, e.g., a patient, is diagnosed before a skin tightening treatment to determine whether a general skin tightening effect is required, e.g., a facelift procedure, or whether a local effect is required, e.g., to locally treat one or more specific wrinkles. In some embodiments, a treatment plan is generated, which optionally includes one or more treatment sessions. As used herein, a treatment session refers to a treatment session or a treatment meeting that ends with the subject being discharged from the clinic after the treatment is completed. In some embodiments, a treatment plan optionally includes multiple treatment sessions.

[0157] Reference is now made to FIG. 6A, which illustrates a skin tightening process, according to some exemplary embodiments of the present invention.

[0158] According to some exemplary embodiments, information about a subject intended to undergo a skin tightening process is collected at block 602. In some embodiments, the information collected includes at least one of the subject's medical history, information about skin elasticity in a particular region of interest (ROI), the depth of one or more wrinkles in the ROI, and / or the density of wrinkles in the ROI.

[0159] According to some exemplary embodiments, a treatment area is determined at block 604. In some embodiments, the treatment area is determined based on the information collected at block 602. In some embodiments, determining the treatment area includes determining whether a global or localized skin tightening process is required based on the size of the treatment area. In some embodiments, the area of ​​the treatment area is greater than 12 cm. 2 If larger, e.g. 20cm 2 If larger, 25cm 2 If larger, 30cm 2 In cases of larger, intermediate treatment area areas, smaller or larger treatment area areas, a full skin tightening process is required.

[0160] According to some exemplary embodiments, at block 606, loose skin tension lines are optionally identified. In some embodiments, loose skin tension lines are identified within or near the determined treatment area, for example, at a distance of up to 10 cm, up to 5 cm, up to 2 cm, or any intermediate, smaller, or larger distance from the determined treatment area. In some embodiments, the identified skin tension lines include at least one of Langer's lines, Cox's lines, Kraissel's lines, Rubin's lines, Straith's lines, Bulacio's lines, and RSTL. In some embodiments, loose skin tension lines are identified using visualization techniques, for example, using optical sensors or cameras. Alternatively or additionally, loose skin tension lines are identified by touching or pinching the skin.

[0161] According to some exemplary embodiments, values ​​of one or more parameters of the tension vector, e.g., the value of the tension vector to be formed by the skin tightening treatment, are optionally determined at block 608. In some embodiments, the tension vector parameters include a tension vector direction, a tension vector position, a tension vector width, a tension vector length, and / or a tension vector shape. In some embodiments, the planned tension vector parameter values ​​are determined with reference to at least some of the skin tension lines identified at block 606. In some embodiments, the direction of the planned tension vector is determined based on a desired skin tightening effect, regardless of whether the desired effect is a global effect (e.g., to create a face lift) or a local effect (e.g., to minimize the appearance of one or more specific wrinkles).

[0162] According to some example embodiments, a treatment plan is generated at block 610. In some embodiments, the generated treatment plan includes the number of treatment sessions and / or values ​​of one or more parameters optionally determined at block 608. In some embodiments, the generated treatment plan includes parameter values ​​of a treatment, e.g., ultrasound treatment, for treating the determined treatment area.

[0163] According to some exemplary embodiments, the treatment parameter values ​​include at least one of the following: type of ultrasound applicator, number of ultrasound transducers, placement of ultrasound transducers, time of energy emission along a given tension vector, and / or duration of rest periods during and / or between treatment sessions during which no energy is emitted into the skin. In some embodiments, the type of ultrasound applicator is based on the shape and size of the ultrasound applicator, for example, the shape and size of the skin contacting surface of the ultrasound applicator. In some embodiments, placement of ultrasound transducers includes the distance between adjacent ultrasound transducers, the number of ultrasound transducers in a row, the number of rows, and / or the angle between adjacent ultrasound transducers. In some embodiments, different treatment parameter values ​​are required for global and localized treatments. Alternatively or additionally, the treatment parameter values ​​are based on at least one of the size of the treatment area, the location of the treatment area, and / or the parameter value of the determined tension vector.

[0164] In some embodiments, the generated treatment plan includes information regarding the number of treatment sessions required to achieve a target effect, e.g., a desired effect, in a particular subject. Additionally, the generated treatment plan includes information regarding the length of the interval between successive treatment sessions, the number of skin locations to be treated in each treatment session, the duration of each treatment session, and the duration of energy delivery at each treatment location.

[0165] According to some exemplary embodiments, the planned tension vectors are optionally marked on the skin at block 612. In some embodiments, the planned tension vectors are optionally marked on the skin using a marker 524 shown in FIG. 5A. Alternatively, a mask (e.g., a gel mask) containing the planned tension vectors is prepared using, for example, a printer 526 shown in FIG. 5A. Optionally, marking the skin includes attaching a sticker to the skin.

[0166] According to some exemplary embodiments, an applicator, e.g., an ultrasound applicator, is optionally selected at block 614. In some embodiments, the applicator is selected based on the size and / or shape of the skin contacting surface of the applicator. Alternatively or additionally, the applicator is selected based on the number of ultrasound transducers and / or the arrangement of the ultrasound transducers in the applicator. Alternatively or additionally, the applicator is selected based on the determined parameters of the tension vector, e.g., to enable the formation of a tension factor having the parameter values ​​determined at block 608.

[0167] According to some exemplary embodiments, at block 616, the applicator is placed in contact with the skin. In some embodiments, the emission faces of at least some of the ultrasound transducers are placed in contact with or near the skin surface, for example, less than 3 cm, less than 2 cm, less than 1 cm from the skin surface, or any intermediate, smaller, or larger distance. In some embodiments, the applicator is placed at a location pre-determined in the treatment plan. Optionally, the applicator is placed in contact with the skin in a determined treatment area. In some embodiments, the applicator and / or transducer is placed in a pre-determined orientation with respect to one or more planned tension markers, optionally marked on the skin.

[0168] According to some exemplary embodiments, at block 618, ultrasonic energy is emitted. In some embodiments, ultrasonic energy is emitted by one or more of the ultrasonic transducers of the applicator toward the skin tissue. In some embodiments, the emitted ultrasonic energy is unfocused (also referred to herein as unfocused) ultrasonic energy. In some embodiments, the skin surface is cooled by the applicator before and / or during the emission of the ultrasonic energy. In some embodiments, ultrasonic energy is emitted for a period of time, optionally selected by a user of the system. Alternatively, ultrasonic energy is emitted for a period of time that is pre-determined as part of the generated treatment plan. In some embodiments, ultrasonic energy is emitted when the applicator and / or transducer is placed in a first position.

[0169] According to some exemplary embodiments, the applicator is optionally moved to another position, e.g., a second position, at block 620. In some embodiments, once the applicator reaches the second position, ultrasonic energy is emitted, e.g., as described in block 618. In some embodiments, the first and second positions are positions along the planned tension vector.

[0170] According to some exemplary embodiments, the applicator is moved by the user from a first position to another position along the path of the planned tension vector. In some embodiments, once the applicator is located at a target position along the path, energy is released, for example as described in block 618. In some embodiments, the applicator is moved from the first position to an adjacent position on the path. Alternatively, the applicator is moved between separate, non-adjacent positions on the path.

[0171] Optionally, the movement pattern of the applicator along the path is pre-determined and optionally becomes part of the generated treatment plan. In some embodiments, the movement pattern of the applicator is determined according to the response of tissue at a particular location to the applied ultrasound energy, for example, if a cooling period is required after treating a first location, the applicator is moved to a remote location to continue the treatment session.

[0172] According to some exemplary embodiments, the applicator is rolled over the skin surface between treatment locations, or the applicator is detached from the skin surface at a first treatment location and attached to the skin surface at a second treatment location.

[0173] According to some exemplary embodiments, the treatment session ends at block 622. In some embodiments, the treatment session ends after application of ultrasound energy to skin tissue at specific locations included in the treatment session and / or included in the generated treatment plan has been completed.

[0174] According to some exemplary embodiments, a post-treatment evaluation is performed at block 624. In some embodiments, a post-treatment evaluation is performed to evaluate the condition of the skin tissue after treatment. In some embodiments, a post-treatment evaluation is performed at the end of each treatment session. Alternatively or additionally, a post-treatment evaluation is performed during a treatment session, such as after delivery of ultrasound energy to a particular treatment site.

[0175] According to some exemplary embodiments, at block 626, the treatment plan is optionally updated. In some embodiments, the treatment plan is updated based on a post-treatment evaluation. In some embodiments, if the effect after the treatment session is not sufficient, delivery of ultrasound energy to one or more previous locations is repeated. In some embodiments, if a particular treatment area requires longer recovery, a remote treatment location is selected for the next treatment session. Optionally, a new tension vector is determined, for example, based on the results of the post-treatment evaluation. For example, if the post-treatment evaluation indicates that the effect after the treatment is not sufficient, a new tension vector is determined.

[0176] According to some exemplary embodiments, a new treatment session is started according to the generated or optionally updated treatment plan, or the treatment session is repeated, etc., according to the updated treatment plan.

[0177] 6B, operations performed by a skin tightening system, such as system 502 shown in FIG. 5A, according to some exemplary embodiments of the present invention will be described.

[0178] According to some exemplary embodiments, the treatment plan is optionally stored in a memory of the system, such as memory 514 shown in Figure 5A. In some embodiments, the stored treatment plan is the treatment plan generated in block 610 of Figure 6A.

[0179] According to some exemplary embodiments, the system optionally marks guide markings on the subject's skin surface at block 642. In some embodiments, the guide markings optionally indicate the location of a planned tension vector. Alternatively or additionally, the guide markings optionally indicate one or more treatment locations for placing an ultrasound applicator in contact with the skin. In some embodiments, the guide markings are optionally applied, e.g., projected, to the subject's skin surface.

[0180] According to some exemplary embodiments, the system optionally determines the position and / or orientation of the ultrasound applicator at block 644. In some embodiments, the system determines the position and / or orientation of the applicator based on signals received from at least one sensor of the applicator, such as a gyroscope and / or an accelerometer. Alternatively or additionally, the system determines the position and / or orientation of the ultrasound applicator by receiving signals from at least one optical sensor (e.g., a camera) operatively connected to a control unit of the system.

[0181] According to some exemplary embodiments, the system optionally identifies the position and / or orientation of the applicator relative to specific landmarks, planned tension vectors, and / or guide markings on the subject's body.

[0182] According to some exemplary embodiments, the system optionally delivers an indication regarding the determined position and / or orientation of the applicator at block 646. In some embodiments, the indication is a human detectable indication, such as, for example, an audio and / or visual indication. In some embodiments, the delivered indication includes a first indication that the applicator is in the planned position and / or orientation and a second indication that the applicator is not in the planned position and / or orientation.

[0183] According to some exemplary embodiments, at block 648, ultrasonic energy is delivered. In some embodiments, ultrasonic energy is optionally delivered automatically when the ultrasonic applicator is in a planned position and / or orientation. Alternatively or additionally, ultrasonic energy is optionally delivered automatically when the ultrasonic applicator is in a target treatment location. Optionally, ultrasonic energy is delivered when the system receives an activation signal from a user interface of the control unit, such as the user interface 522 shown in FIG. 5A, or a user interface of the ultrasonic applicator. In some embodiments, the system generates and delivers ultrasonic energy according to treatment parameter values ​​stored in memory and / or according to at least one treatment plan stored in memory.

[0184] According to some exemplary embodiments, the system stops delivering ultrasound energy at block 650. In some embodiments, the system stops delivering ultrasound energy automatically, for example, according to treatment parameter values ​​stored in memory and / or at least one treatment plan, or upon receiving a signal from a user interface of the control unit or a user interface of the applicator.

[0185] According to some exemplary embodiments, the system optionally delivers instructions regarding moving the applicator to additional treatment locations at block 652. In some embodiments, the system optionally delivers the instructions using, for example, a map or visual display presented by a user interface of the control unit or a user interface of the applicator. In some embodiments, the process optionally continues, for example, until the treatment session is terminated, as described at block 644.

[0186] Exemplary directional tension vectors on the facial skin According to some exemplary embodiments, a skin tightening procedure may produce the effects of a facelift or mini-facelift procedure in a non-invasive manner. Reference is now made to Figures 7A-7D, which show treatment areas of an applicator on a subject's face, according to some exemplary embodiments of the present invention.

[0187] According to some exemplary embodiments, elongated ultrasound transducers, each optionally having an elongated piezoelectric element, are moved over the skin between different treatment areas, e.g., treatment areas 702 and 704, as shown in, e.g., FIG. 7A and FIG. 7B. In some embodiments, elongated ultrasound transducers, e.g., seven ultrasound transducers, are arranged in a row, as shown in, e.g., FIG. 7A and FIG. 7B. In some embodiments, a skin contacting surface of the applicator is placed in contact with the skin of a first treatment area, e.g., treatment area 702, and delivers ultrasound energy to the skin tissue of the first treatment area 702. The applicator is then moved to an additional treatment area, e.g., treatment area 704, distributed along at least one planned tension vector 706 on the subject's skin, e.g., facial skin and / or neck skin.

[0188] According to some exemplary embodiments, the long axis of the elongated ultrasonic transducer, e.g., the long axis of the rectangular piezoelectric element, is aligned with a line on the skin that is substantially perpendicular to the skin tension line 708, e.g., the RSTL line, e.g., at least one planned tension vector 706. In some embodiments, the skin tightening treatment consists of starting on one inner side of the face and then performing adjacent applications of ultrasonic energy along a direction that is substantially perpendicular to the skin tension line, e.g., the RSTL line. Optionally, the treatment includes applying ultrasonic energy with or without a more upward vertical component relative to the body's longitudinal axis 710, depending on the particular patient's treatment program and / or the system user's technique.

[0189] Optionally, the treatment may consist of performing two or more passes on each side of the face to perform collagen contraction and skin tightening in a direction substantially perpendicular to the skin tension line, for example at least one initial pass to the RSTL and at least one additional pass in a more perpendicular direction. Optionally, the method of treating the skin by applying a series of these burns to the skin may combine these two principles, starting from the center of the face in a direction substantially perpendicular to the RSTL, and then curving upwards towards the outside of the face in a direction more perpendicular to the longitudinal axis 710 of the body. Optionally, the applied energy overlaps in one or more directions, but is still generated to generally replicate the skin tightening and pulling effect of a facelift or mini facelift.

[0190] According to some exemplary embodiments, for treatment of the lower face, the desired collagen contraction and skin tightening direction starts from a medial-lateral position, and these lines are substantially perpendicular to the RSTL lines shown in Figures IB and 7A-7D. In some embodiments, for treatment of the forehead, as another example, the desired collagen contraction and skin tightening direction is substantially parallel to the longitudinal axis 710 to provide a vertical lift to treat forehead wrinkles, and / or brow lift, etc. Optionally, these lines are substantially perpendicular to the RSTL lines in the forehead region, as shown in Figures IB and 7A-7D.

[0191] FIG. 7A shows an example of an irradiation pattern for creating lines of collagen contraction and skin tightening, according to some exemplary embodiments of the present invention. In FIG. 7A, each rectangle represents a 1×5 mm piezoelectric element footprint of an ultrasound applicator. The seven rectangles aligned along the short axis of the piezoelectric element represent seven transducers attached to an applicator, such as a hand piece. The numbers 1 through 12 represent adjacent energy applications at different adjacent locations to create lines of collagen contraction and skin tightening in a desired direction along the long axis of an elongated ultrasound transducer.

[0192] In some embodiments, for example as shown in FIG. 7A, the long axis of each piezoelectric element is generally aligned, e.g., at least 80% aligned perpendicular to the RSTL line (e.g., line 708), thereby optionally generating a line of collagen contraction and skin tightening substantially perpendicular to the RSTL line.

[0193] In some embodiments, for example as shown in FIG. 7B, ultrasonic energy is applied when the long axis of the piezoelectric element is generally aligned in a more vertical direction closer to the longitudinal axis 710 of the body, which results in more vertical collagen contraction and skin tightening, for example by lifting the skin upward to overcome the effects of gravity on sagging skin.

[0194] According to some exemplary embodiments, different forms of energy irradiation are used to create collagen contraction and skin tightening vectors. In some embodiments, focused ultrasound energy is used to create cylindrical focal regions in tissue, such as thermal lesions. Alternatively, non-invasive or minimally invasive (such as microneedles) bipolar or monopolar elongated RF electrodes are used to generate thermal lesions. Alternatively, a system using a non-ablative laser emitted in an elongated form against the skin surface is used to deposit energy in the dermis layer. Optionally, a skin surface cooling method is used to protect the superficial layers of the skin (optionally including the epidermis, dermal-epidermal junction, and / or papillary dermis).

[0195] According to some exemplary embodiments, non-elongated, optionally symmetric transducers are used to cause collagen contraction and / or skin tightening in a desired direction, as shown, for example, in Figures 7C and 7D. In some embodiments, non-elongated transducers, each having a footprint 724, generate non-elongated fractionated thermal damage lesions in the skin. Optionally, by moving the ultrasound transducer between treatment areas distributed along at least one desired tension vector 726 on the skin, fractionated thermal damage lesions, optionally including at least partially denatured collagen, are formed along the planned tension vector 726, thereby causing collagen contraction and / or skin tightening in the direction of the planned tension vector 726. In some embodiments, the density of fractionated thermal damage lesions generated by non-elongated transducers is higher in the direction of the planned tension vector 726.

[0196] According to some exemplary embodiments, the direction of the planned tension vectors 726 are generally aligned perpendicular to the RSTL line 708, as shown, for example, in Figure 7C, creating a collagen contraction and skin tightening line perpendicular to the RSTL line 708, as shown, for example, in Figure 7A. In some embodiments, the direction of the planned tension vectors 726 created by the fractionated thermal damage lesions is more vertical and closer to the longitudinal axis 730 of the body, creating an upward skin tightening effect, for example, to overcome the effect of gravity on loose skin, as shown, for example, in Figure 7D.

[0197] According to some exemplary embodiments, ultrasound energy is applied to create a segmented thermal injury lesion in the superficial musculoaponeurotic system (SMAS) layer. In some embodiments, to affect the SMAS layer, an energy emitting transducer, e.g., an ultrasound transducer, is activated to create a thermal injury lesion along a vertical planned tension vector proximate to the longitudinal axis 730 of the body, e.g., as shown in Figures 7B and 7D.

[0198] According to some exemplary embodiments, as shown, for example, in FIG. 8, the tension vectors to be generated by the segmented thermal damage lesions are curvilinear, for example to produce curvilinear skin tightening.

[0199] Example Simulation Description of a typical FEA model Simulations were performed to characterize the energy deposition in the Sofwave device in 3D to calculate the volume of denatured collagen, taking into account edge effects due to the finite length of the PZT. Additionally, simulations were performed to calculate the expected collagen contraction in three orthogonal axes.

[0200] The model used for the simulations was based on the geometry shown in Figure 9. To reduce computational and memory requirements, only the dermis and subcutaneous tissue layers were modeled. Furthermore, to exploit the inherent symmetry associated with the model, only a quarter model with two symmetry planes was implemented. The model is surrounded by a Perfectly Matched Layer (PML), which absorbs all remaining ultrasound energy without causing any reflections.

[0201] The PZT was modeled by a rectangular surface with constant pressure. The first step was to model the deposition of acoustic energy in the tissue layers. Following the acoustic simulation, the acoustic power deposited in the tissue was used as an external source for the heat transfer module to calculate the thermal profile generated by the absorption of acoustic energy in the dermal and subcutaneous layers. The thermal damage predicted by the Arrhenius equation was then calculated using Eq.

number

[0202] The acoustic and thermal properties relevant to the simulation are given below in Table 1. For the acoustic properties, the values ​​were taken at 11.5 MHz, the frequency used by the Sofwave console. [Table 1] To mimic the thermal effect of the proprietary embedded cooling system, the average temperature at the dermis-surface interface during the ultrasound pulse was calculated to be 15 °C using a cross-sectional 2D model and applied as a constant temperature condition to the PZT surface in Figure 9 .

[0203] The minimum and maximum mesh sizes of the model were set to 5.7E-3 and 5.7E-2 mm, respectively.

[0204] Tissue temperature and areas of denatured collagen - 3D Temperature profiles were simulated with energy settings of 3, 4, and 5 J. Thermal damage levels were then calculated using Equation 1, as previously described, to generate volumes enclosed by contour lines of 10, 25, 50, and 95% collagen denaturation, as shown in Figure 10 (Figure 10 shows the volume of denatured collagen between 3 J and 5 J. The curves represent the volumes enclosed by isosurfaces of the same percentage of collagen denaturation. The corresponding maximum skin temperatures are shown on the top axis).

[0205] The volume enclosed by 10% denatured collagen is shown in Figure 11 (Figure 11 shows the volume enclosed by 10% denatured collagen 1102 (green)). The simulation results were mirrored across two symmetry planes and copied seven times with a distance of 4 mm between two adjacent PZTs to replicate the design of the Sofwave handpiece.

[0206] The center of the denatured area was located approximately 1.5 mm below the skin surface and was entirely located in the dermal layer. This zone had a quasi-elliptical 3D shape completely surrounded by non-denatured collagen and was partial by definition. The cooling system of the handpiece ensured a zone of non-denatured collagen above the denatured zone, down to the level of the dermal surface.

[0207] Collagen Contraction Collagen molecules are composed of triple helical tropocollagen molecules with a length of about 300 nm and a diameter of 1.5 nm. Collagen molecules are arranged alternately to form fibrils, which then arrange to form collagen fibers. Like other biological proteins, collagen can be denatured when heated. During the denaturation process, the triple helical structure gradually changes its 3D conformational configuration by breaking various crosslinks present at the intermolecular level, such as non-enzymatic glycosylation of lysine and hydroxylysine residues, and at the intramolecular level, such as disulfide bonds. These complex phenomena result in a decrease in length, or contraction. When collagen concentration is high in a tissue, such as the skin, the result is a contraction of the entire tissue. This phenomenon can be used for non-invasive or minimally invasive skin tightening procedures and / or to mimic facelift procedures, in which plastic surgeons typically pull the skin in the direction of the "line of maximum extensibility" (LME) to soften or eliminate facial wrinkles that are generally located along the "line of relaxed skin tension" (RSTL), as shown in FIG. 12, and is used in some embodiments of the present invention. The purpose of this section is to characterize collagen contraction caused by the amount of heat applied to the dermis by a simulated Sofwave applicator.

[0208] Collagen Contraction - Methodology Lin et al. characterized collagen contraction resulting from heat exposure of rat tendons to 58°C for up to 15 minutes, and the contraction length vs. time obtained at 58°C is shown in Figure 13 (Figure 13 in Lin et al. shows the change in length of rat tail tendons due to heat treatment at 58°C. Error bars represent standard deviation).

[0209] Since the temperature and time in thermal variables are known, the amount of heat received by the collagen fibers can be calculated using the Arrhenius equation (1), along with the activation energy (E) and frequency factor (A). The relationship between collagen contraction and the associated amount of heat (Ω) reported by Lin et al. is shown in Figure 14. (Figure 14 shows the relationship between collagen contraction and the amount of heat. The bullet numbers represent the remaining length after contraction.)

[0210] These results were then programmed into a commercially available finite element analysis software (Comsol) using a look-up table function to assign levels of collagen contraction to calculated dermal thermal masses. Because the original collagen contraction data was obtained from animal tendons and not human skin, the absolute values ​​should not be considered representative of skin. However, the contraction ratios in the three orthogonal directions should be fairly representative in indicating the direction of contraction. These ratios are discussed in the next section.

[0211] Collagen Contraction - Simulation Results Based on the thermal dose Ω obtained in this section, the collagen deformation rate ξ was calculated. The results obtained at a setting of 3.6 J are shown in Figure 15 (the left panel of Figure 15 shows the thermal dose of the dermis at 3.6 J, and the right panel shows the corresponding collagen deformation).

[0212] To calculate the absolute contractility of collagen, the projection (or line integral) of the collagen deformation field ξ was calculated and plotted in the plane perpendicular to the integration direction. The line integral method and results are shown in Figure 16 (shown in the left panel of Figure 16, where the collagen deformation field ξ is integrated in one direction and plotted in a perpendicular plane. In this example, ξ is integrated in the y direction along the red arrow and plotted in the yellow hatched plane (xz plane). Right panel - projection results are shown in three perpendicular planes).

[0213] From these results, the maximum collagen contraction values ​​in three orthogonal planes were extracted and the ratio of the two collagen contraction values ​​was calculated. This is shown in FIG. 17 for energy settings of 3, 3.6, 4, and 5 J. The ratio of interest is the "lateral contraction ratio" obtained by dividing the collagen contraction value along the PZT major axis by the value along the PZT minor axis (and is defined as "major / minor PZT axis" in the blue curve 1602 of FIG. 17). These two directions are along the surface of the skin. The results show that between 3J and 4J, the lateral contraction ratio along the PZT major axis (i.e., the preferred direction) was about 7:1, decreasing to about 5:1 at 5 J. The other contraction ratios, defined as "PZT major axis / depth" and "PZT minor axis / depth" (shown in the red curve 1604 and grey curve 1606 of FIG. 17, respectively), showed smaller values. For the "PZT major / minor" ratio, it started at about 2.1 at 3.0 J, reached a maximum of about 4.6 at about 3.8 J, and then decreased to about 3.0 at 5.0 J. These ratio values ​​themselves can be used to calculate the ratio of the ratio values ​​based on the results shown in Figure 17. For the example using the results obtained at 3.6 J, dividing the "PZT major / minor" by the "PZT major / minor" value gives a ratio of about 7.0 / 4.2=1.67.

[0214] Since the collagen contraction value in a direction is the line integral of the contraction in that direction, it can be understood that increasing the dimension of the PZT (or other type of transducer) along that direction will increase the collagen contraction value. Thus, for example, a PZT transducer that is 5 mm or longer along its major axis (or major axis) and 1 mm wide along its minor axis will have a "lateral contraction ratio" (or PZT major axis / minor axis in FIG. 17) value that is greater than the obtained value of about 7:1 reported in this document. Conversely, the shorter the PZT value along the major axis, the smaller the lateral contraction ratio. In some embodiments, as described above, energy is applied to the skin to contract the collagen in a preferred direction, resulting in a lateral contraction ratio of at least about 1.5:1, e.g., a lateral contraction ratio of at least about 1.7:1, at least about 2:1, at least about 2.5:1, at least about 3:1, at least about 4:1, or any smaller or larger contraction ratio.

[0215] Unlike most energy-based techniques designed to produce relatively isotropic collagen denaturation in the dermis, the PZT transducer used in the Sofwave handpiece can produce elongated collagen denaturation along the PZT major axis, as shown in Figure 14. This is due to the design of the PZT transducer, which has an asymmetric rectangular footprint of 1 x 5 mm. The anisotropy of collagen denaturation results in a planned, e.g. preferred, direction of collagen contraction. Using this planned direction of contraction, contraction in a particular direction can be maximized to produce the desired effect. In the field of aesthetics, a preferred contraction direction can be brought about along or substantially along the LME line shown in Figure 12 to at least partially mimic the desired cosmetic effect of a facelift. In practice, this is done by placing the long PZT axis along or substantially along the LME line for most or all of the acoustic pulses used to treat the desired facial area. The same concept applies to the neck, where the LME line runs generally vertically and the line is generally perpendicular to the mandible. This technology can be used to improve the appearance or treat wrinkles on any part of the body, such as the neck, décolleté, knees, arms, abdomen, arms, legs, thighs, and legs, to name a few.

[0216] Creating thermal damage to produce collagen tightening or contraction along a preferred direction is also useful for tightening collagen-rich tissues, such as ligaments, to treat joints prone to dislocation or to achieve other desired mechanical tightening effect(s), including, but not limited to, the shoulder, elbow, wrist, finger, hip, knee, ankle, toe, neck, and / or spine.

[0217] Similarly, dysfunctional sphincters that tend to close improperly may be targeted. In such applications, collagen in the tissue surrounding the sphincter is denatured or contracted in a direction that helps the sphincter to restore normal function. Generally speaking, this can be accomplished by shrinking (or contracting) the circumference of the sphincter, helping it to close properly. As a result, the preferred direction of collagen contraction is parallel to the circumference of the sphincter, or in other words perpendicular or substantially perpendicular to the radial line. These procedures can be used to target the esophageal sphincter to treat GERD, gastric reflux disorders, fecal incontinence, and urinary incontinence. The same principle applies to vaginal tightening, where the preferred direction of collagen contraction is along the vaginal wall in a direction perpendicular to the major axis of the vagina.

[0218] Aesthetic procedures targeting cartilage may also use this technique where length reduction parallel to the preferred direction of collagen contraction is generally desired, such as in otoplasty and rhinoplasty, but are not limited to these.

[0219] Additionally, the procedures described above may also be used to perform and / or enhance cardiac valvuloplasty.

[0220] The simulation results demonstrate that the finite element analysis model has been validated and is capable of predicting the burn that occurs at various clinically relevant settings. Based on the results, and in some embodiments, it is expected that clinical results will be obtained using settings between about 3J and about 4.5J, such as between about 3.5J and about 4J, such as between about 3.5J and about 4.5J. Furthermore, the 3D simulation results demonstrate that collagen contraction in a preferred direction along the major axis of the PZT is achieved. This is beneficial in one application to create directional skin tightening and partially mimic the effect of a facelift.

[0221] It is expected that many related ultrasound transducers will be developed during the life of the patent which matures from this application, and the scope of the term ultrasound transducer is intended to include a priori all such new technologies.

[0222] The terms "comprises," "comprising," "includes," "including," "has," "having" and their conjugations mean "including, but not limited to."

[0223] The term "consisting of" means "including and limited to."

[0224] The term "consisting essentially of" means that a composition, method, or structure may include additional components, steps, and / or moieties, provided that the additional components, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0225] As used herein, the singular forms "a," "an," and "the" include plural referents 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.

[0226] Throughout this application, embodiments of the invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Thus, the description of a range should be considered to specifically disclose all possible subranges as well as individual numerical values ​​within that range. For example, the description of a range such as "1 to 6" should be considered to specifically disclose subranges such as "1 to 3", "1 to 4", "1 to 5", "2 to 4", "2 to 6", "3 to 6", etc., as well as individual numerical values ​​within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0227] When a range of numerical values ​​is given herein (e.g., any pair of numerical values ​​joined by "10-15," "10 to 15," or another such range designator), it is meant to include any numerical value (fractional or integer) within the limits of the stated range, including the limits of the range, unless the context clearly dictates otherwise. The phrases "range / ranging / ranges between" a first designator and a second designator, and the phrases "range / ranging / ranges from" a first designator "to," "up to," "until," or "through" a second designator, are used interchangeably herein and are meant to include the first designator and the second designator, and all fractional and integer numbers therebetween.

[0228] Unless otherwise indicated, the numerical values ​​used herein and any numerical ranges based thereon are approximations within reasonable measurement precision and rounding errors that one of ordinary skill in the art would understand.

[0229] The term "method" as used herein refers to methods, means, techniques and procedures for accomplishing a given task, including but not limited to methods, means, techniques and procedures known to the practitioner of the chemical, pharmacological, biological, biochemical and medical arts or readily developed from known methods, means, techniques and procedures.

[0230] As used herein, the term "treating" includes preventing, substantially inhibiting, slowing, or reversing the progression of a condition, substantially ameliorating the clinical or cosmetic symptoms of a condition, or substantially preventing the appearance of clinical or cosmetic symptoms of a condition.

[0231] It is understood that certain features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination, or as appropriate in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be construed as essential features of those embodiments, unless the embodiment is inoperable without those elements.

[0232] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0233] It is the intention of the applicant(s) that all publications, patents, and patent applications mentioned herein may be incorporated herein by reference in their entirety as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. Furthermore, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. Section headings, if used, should not be construed as necessarily limiting. Additionally, any priority document(s) of this application are hereby incorporated herein by reference in their entirety.

Claims

1. 1. A skin tightening system, comprising: an applicator including at least one energy-emitting transducer configured to generate and deliver energy to skin tissue; a user interface configured to deliver a human-detectable indication to a user of the system; a memory storing information regarding at least one desired skin tightening vector in the subject's skin; a control circuit operatively connected to the user interface; the control circuitry is configured to generate at least one alignment indication indicating alignment of the energy-emitting transducer on the skin surface, send signals to the user interface to deliver the at least one alignment indication of the at least one energy-emitting transducer, and further send signals to the at least one energy-emitting transducer to generate and deliver energy at parameter values ​​sufficient to generate directional skin tightening in at least one skin region.

2. 2. The system of claim 1, wherein the stored information regarding the at least one desired skin tightening vector includes positioning information of one or more treatment locations along the at least one desired skin tightening vector, used to position the applicator and / or the at least one energy-emitting transducer and deliver the energy.

3. The system of claim 1 , wherein the at least one desired skin tightening vector is determined based on the type and / or location of a cosmetic procedure planned for the subject.

4. The system of claim 3 , wherein the cosmetic procedure comprises a facelift or a mini-facelift.

5. The system of claim 1 , wherein the at least one desired skin tightening vector is determined based on existing skin tension lines of the subject's skin.

6. 6. The system of claim 5, wherein the existing lines of skin tension include at least one of Langer's lines, Cox's lines, Kraissel's lines, Rubin's lines, Straith's lines, Bulacio's lines, and relaxed skin tension lines (RSTL).

7. The system of claim 1 , wherein the control circuitry is configured to generate the at least one alignment indication based on the stored information regarding the at least one desired skin tightening vector in the skin.

8. 10. The system of claim 1, wherein the control circuitry is configured to send signals to the at least one energy-emitting transducer to generate and deliver the energy at appropriate parameter values ​​to at least partially mimic the cosmetic effect of a mini-facelift or facelift in the at least one skin area.

9. 2. The system of claim 1, wherein the control circuitry is configured to send signals to the at least one energy-emitting transducer to generate and deliver the energy at parameter values ​​suitable for forming thermal damage lesions in deeper tissue layers of the skin along the desired skin tightening vector.

10. The system of claim 9 , wherein the parameter values ​​are suitable for contracting or denaturing collagen fibers along the desired skin tightening vector.

11. The system of claim 1 , wherein the at least one energy-emitting transducer comprises an ultrasound transducer and / or an RF transducer.

12. The system of claim 11 , wherein the ultrasound transducer is configured to apply unfocused ultrasound energy.

13. 12. The system of claim 11, comprising a cooling module configured to apply cooling to a surface of the skin through a skin-contacting surface of the applicator during activation of the at least one energy-emitting transducer by the control circuit.

14. 14. The system of claim 1, wherein the control circuitry is configured to receive signals from at least one sensor and generate the at least one alignment indication based on the received signals, the at least one sensor comprising a position and / or orientation sensor.

15. The system of claim 14 , wherein the applicator includes the at least one sensor, the sensor including a gyroscope and / or an accelerometer.

16. The system of any one of claims 1 to 13, wherein the control circuitry is configured to receive signals from at least one camera and to generate the at least one alignment indication based on the received signals.

17. 14. The system of any one of claims 1 to 13, wherein the user interface includes a display, and the control circuitry is configured to send a signal to the user interface to cause the display to display the at least one alignment indication.

18. The system of claim 2 , wherein the at least one alignment indication includes information regarding the position and / or orientation of the at least one energy-emitting transducer relative to the one or more treatment locations and / or includes information regarding the desired skin tightening vector.

19. 11. The system of claim 1, wherein the energy-emitting transducer includes at least one ultrasound transducer configured to deliver unfocused ultrasound energy to the skin, and the control circuitry activates the ultrasound transducer according to values ​​of activation parameters sufficient to at least partially denature collagen fibers in at least one tissue volume within a deep tissue layer of the skin, the activation parameters including at least one of an ultrasound frequency, an ultrasound intensity, an energy level per pulse of ultrasound energy delivered to the skin, and a pulse duration.

20. 20. The system of claim 19, wherein the value of the actuation parameter is sufficient to cause a contraction of the collagen fibers along their major axes that is at least two times greater than the contraction caused by the value of the actuation parameter in their minor axes.

21. The frequency of the ultrasonic waves is in the range of 5 MHz to 22 MHz, and the intensity of the ultrasonic waves is in the range of 8 to 40 W / cm ２ 20. The system of claim 19, wherein the energy level per pulse of the ultrasound is in the range of 2 to 5 Joules, and / or the duration of each pulse of the ultrasound energy is in the range of 1 to 10 seconds.

22. 1. A method for producing cosmetic non-therapeutic directional skin tightening, comprising: providing at least one alignment indicia indicating alignment of at least one energy-emitting transducer on the skin surface according to at least one desired skin tightening vector; aligning the at least one energy-emitting transducer on a surface of the skin according to the at least one alignment indicia; irradiating energy with the at least one aligned energy-emitting transducer; repeating said aligning and said irradiating until cosmetically beneficial directional skin tightening occurs.

23. 23. The method of claim 22, wherein the irradiating comprises applying unfocused ultrasound energy with the aligned energy-emitting transducers, the application being performed at parameter values ​​suitable for forming spaced-apart thermal damage lesions to produce the cosmetically beneficial directional skin tightening, the cosmetically beneficial directional skin tightening at least partially mimicking the cosmetic effects of a facelift or mini-facelift in the subject.

24. 24. The method of claim 22 or 23, comprising cooling the surface of the skin during said irradiating.

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