US20140187944A1 - Noninvasive tissue tightening system - Google Patents
Noninvasive tissue tightening system Download PDFInfo
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- US20140187944A1 US20140187944A1 US14/200,852 US201414200852A US2014187944A1 US 20140187944 A1 US20140187944 A1 US 20140187944A1 US 201414200852 A US201414200852 A US 201414200852A US 2014187944 A1 US2014187944 A1 US 2014187944A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
- A61B8/4483—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device characterised by features of the ultrasound transducer
- A61B8/4494—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device characterised by features of the ultrasound transducer characterised by the arrangement of the transducer elements
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
- A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
- A61B8/085—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/42—Details of probe positioning or probe attachment to the patient
- A61B8/4272—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
- A61B8/4281—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by sound-transmitting media or devices for coupling the transducer to the tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
- A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N7/02—Localised ultrasound hyperthermia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/13—Tomography
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/42—Details of probe positioning or probe attachment to the patient
- A61B8/4209—Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/54—Control of the diagnostic device
- A61B8/546—Control of the diagnostic device involving monitoring or regulation of device temperature
Abstract
Systems and methods for noninvasive tissue tightening are disclosed. Thermal treatment of tissues such as superficial muscular aponeurosis system (SMAS) tissue, muscle, adipose tissue, dermal tissue, and combinations thereof are described. In one aspect, a system is configured for treating tissue through delivery of ultrasound energy at a depth, distribution, temperature, and energy level to achieve a desired cosmetic effect.
Description
- This application is a continuation of U.S. application Ser. No. 13/924,376 titled “Noninvasive Tissue Tightening For Cosmetic Effects” filed on Jun. 21, 2013, which is a continuation of U.S. application Ser. No. 13/679,430 titled “Ultrasound Treatment Of Sub-Dermal Tissue For Cosmetic Effects” filed on Nov. 16, 2012 and issued as U.S. Pat. No. 8,506,486, which is a continuation of U.S. application Ser. No. 13/444,336 titled “Treatment Of Sub-Dermal Regions For Cosmetic Effects” filed on Apr. 11, 2012 and issued as U.S. Pat. No. 8,366,622, which is a continuation of U.S. application Ser. No. 11/163,151 titled “Method And System For Noninvasive Face Lifts And Deep Tissue Tightening” filed on Oct. 6, 2005, now abandoned, which claims the benefit of priority to U.S. Provisional Application No. 60/616,755, titled “Method And System For Noninvasive Face Lifts And Deep Tissue Tightening” filed on Oct. 6, 2004, each of which is incorporated in its entirety by reference herein. Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57.
- 1. Field of the Invention
- The present invention relates to ultrasound therapy and imaging systems, and in particular to a method and system for noninvasive face lifts and deep tissue tightening.
- 2. Description of the Related Art
- Coarse sagging of the skin and facial musculature occurs gradually over time due to gravity and chronic changes in connective tissue generally associated with aging. Invasive surgical treatment to tighten such tissues is common, for example by facelift procedures. In these treatments for connective tissue sagging, a portion of the tissue is usually removed, and sutures or other fasteners are used to suspend the sagging tissue structures. On the face, the Superficial Muscular Aponeurosis System (SMAS) forms a continuous layer superficial to the muscles of facial expression and beneath the skin and subcutaneous fat. Conventional face lift operations involve suspension of the SMAS through such suture and fastener procedures.
- No present procedures have been developed yet, which provide the combination of targeted, precise, local heating to a specified temperature region capable of inducing ablation (thermal injury) to underlying skin and subcutaneous fat. Attempts have included the use of radio frequency (RF) devices that have been used to produce heating and shrinkage of skin on the face with some limited success as a non-invasive alternative to surgical lifting procedures. However, RF is a dispersive form of energy deposition. RF energy is impossible to control precisely within the heated tissue volume and depth, because resistive heating of tissues by RF energy occurs along the entire path of electrical conduction through tissues. Another restriction of RF energy for non-invasive tightening of the SMAS is unwanted destruction of the overlying fat and skin layers. The electric impedance to RF within fat, overlying the suspensory connective structures intended for shrinking, leads to higher temperatures in the fat than in the target suspensory structures. Similarly, mid-infrared lasers and other light sources have been used to non-invasively heat and shrink connective tissues of the dermis, again with limited success. However, light is not capable of non-invasive treatment of SMAS because light does not penetrate deeply enough to produce local heating there. Below a depth of approximately 1 mm, light energy is multiply scattered and cannot be focused to achieve precise local heating.
- A method and system for noninvasive face lifts and deep tissue tightening are provided. An exemplary method and treatment system are configured for the imaging, monitoring, and thermal injury to treat the SMAS region. In accordance with an exemplary embodiment, the exemplary method and system are configured for treating the SMAS region by first, imaging of the region of interest for localization of the treatment area and surrounding structures, second, delivery of ultrasound energy at a depth, distribution, timing, and energy level to achieve the desired therapeutic effect, and third to monitor the treatment area before, during, and after therapy to plan and assess the results and/or provide feedback.
- In accordance with an exemplary embodiment, an exemplary treatment system comprises an imaging/therapy probe, a control system and display system. The imaging/therapy probe can comprise various probe and/or transducer configurations. For example, the probe can be configured for a combined dual-mode imaging/therapy transducer, coupled or co-housed imaging/therapy transducers, or simply a therapy probe and an imaging probe. The control system and display system can also comprise various configurations for controlling probe and system functionality, including for example a microprocessor with software and a plurality of input/output devices, a system for controlling electronic and/or mechanical scanning and/or multiplexing of transducers, a system for power delivery, systems for monitoring, systems for sensing the spatial position of the probe and/or transducers, and systems for handling user input and recording treatment results, among others.
- In accordance with an exemplary embodiment, ultrasound imaging can be utilized for safety purposes, such as to avoid injuring vital structures such as the facial nerve (motor nerve), parotid gland, facial artery, and trigeminal nerve (for sensory functions) among others. For example, ultrasound imaging can be used to identify SMAS as the superficial layer well defined by echoes overlying the facial muscles. Such muscles can be readily seen and better identified by moving them, and their image may be further enhanced via signal and image processing.
- In accordance with an exemplary embodiment, ultrasound therapy via focused ultrasound, an array of foci, a locus of foci, a line focus, and/or diffraction patterns from single element, multiple elements, annular array, one-, two-, or three-dimensional arrays, broadband transducers, and/or combinations thereof, with or without lenses, acoustic components, mechanical and/or electronic focusing are utilized to treat the SMAS region at fixed and/or variable depth or dynamically controllable depths and positions.
- The subject matter of the invention is particularly pointed out in the concluding portion of the specification. The invention, however, both as to organization and method of operation, may best be understood by reference to the following description taken in conjunction with the accompanying drawing figures, in which like parts may be referred to by like numerals:
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FIG. 1 illustrates a block diagram of a treatment system in accordance with an exemplary embodiment of the present invention; -
FIGS. 2A-2F illustrates schematic diagrams of an ultrasound imaging/therapy and monitoring system for treating the SMAS layer in accordance with various exemplary embodiments of the present invention; -
FIGS. 3A and 3B illustrate block diagrams of an exemplary control system in accordance with exemplary embodiments of the present invention; -
FIGS. 4A and 4B illustrate block diagrams of an exemplary probe system in accordance with exemplary embodiments of the present invention; -
FIG. 5 illustrates a cross-sectional diagram of an exemplary transducer in accordance with an exemplary embodiment of the present invention; -
FIGS. 6A and 6B illustrate cross-sectional diagrams of an exemplary transducer in accordance with exemplary embodiments of the present invention; -
FIG. 7 illustrates exemplary transducer configurations for ultrasound treatment in accordance with various exemplary embodiments of the present invention; -
FIGS. 8A and 8B illustrate cross-sectional diagrams of an exemplary transducer in accordance with another exemplary embodiment of the present invention; -
FIG. 9 illustrates an exemplary transducer configured as a two-dimensional array for ultrasound treatment in accordance with an exemplary embodiment of the present invention; -
FIGS. 10A-10F illustrate cross-sectional diagrams of exemplary transducers in accordance with other exemplary embodiments of the present invention; -
FIG. 11 illustrates a schematic diagram of an acoustic coupling and cooling system in accordance with an exemplary embodiment of the present invention; -
FIG. 12 illustrates a block diagram of a treatment system comprising an ultrasound treatment subsystem combined with additional subsystems and methods of treatment monitoring and/or treatment imaging as well as a secondary treatment subsystem in accordance with an exemplary embodiment of the present invention; and -
FIG. 13 illustrates a schematic diagram with imaging, therapy, or monitoring being provided with one or more active or passive oral inserts in accordance with an exemplary embodiment of the present invention. - The present invention may be described herein in terms of various functional components and processing steps. It should be appreciated that such components and steps may be realized by any number of hardware components configured to perform the specified functions. For example, the present invention may employ various medical treatment devices, visual imaging and display devices, input terminals and the like, which may carry out a variety of functions under the control of one or more control systems or other control devices. In addition, the present invention may be practiced in any number of medical contexts and that the exemplary embodiments relating to a method and system for noninvasive face lift and deep tissue tightening as described herein are merely indicative of exemplary applications for the invention. For example, the principles, features and methods discussed may be applied to any SMAS-like muscular fascia, such as platysma, temporal fascia, and/or occipital fascia, or any other medical application. Further, various aspects of the present invention may be suitably applied to other applications.
- In accordance with various aspects of the present invention, a method and system for noninvasive face lifts and deep tissue tightening are provided. For example, in accordance with an exemplary embodiment, with reference to
FIG. 1 , anexemplary treatment system 100 configured to treat a region ofinterest 106 comprises acontrol system 102, an imaging/therapy probe withacoustic coupling 104, and adisplay system 108.Control system 102 anddisplay system 108 can comprise various configurations for controllingprobe 102 andoverall system 100 functionality, such as, for example, a microprocessor with software and a plurality of input/output devices, system and devices for controlling electronic and/or mechanical scanning and/or multiplexing of transducers, a system for power delivery, systems for monitoring, systems for sensing the spatial position of the probe and/or transducers, and/or systems for handling user input and recording treatment results, among others. Imaging/therapy probe 104 can comprise various probe and/or transducer configurations. For example, probe 104 can be configured for a combined dual-mode imaging/therapy transducer, coupled or co-housed imaging/therapy transducers, or simply a separate therapy probe and an imaging probe. - In accordance with an exemplary embodiment,
treatment system 100 is configured for treating the SMAS region by first, imaging of region ofinterest 106 for localization of the treatment area and surrounding structures, second, delivery of ultrasound energy at a depth, distribution, timing, and energy level to achieve the desired therapeutic effect, and third to monitor the treatment area before, during, and after therapy to plan and assess the results and/or provide feedback. - As to the treatment of the SMAS region, connective tissue can be permanently tightened by thermal treatment to temperatures about 60 degrees C. or higher. Upon ablating, collagen fibers shrink immediately by approximately 30% of their length. The shrunken fibers can produce tightening of the tissue, wherein the shrinkage should occur along the dominant direction of the collagen fibers. Throughout the body, collagen fibers are laid down in connective tissues along the lines of chronic stress (tension). On the aged face, the collagen fibers of the SMAS region are predominantly oriented along the lines of gravitational tension. Shrinkage of these fibers results in tightening of the SMAS in the direction desired for correction of laxity and sagging due to aging. The treatment comprises the ablation of specific regions of the SMAS region and similar suspensory connective tissues.
- In addition, the SMAS region varies in depth and thickness at different locations, e.g., between 0.5 mm to 5 mm or more. On the face, important structures such as nerves, parotid gland, arteries and veins are present over, under or near the SMAS region. Tightening of the SMAS in certain locations, such as the preauricular region associated with sagging of the cheek to create jowls, the frontal region to associated with sagging brows, mandibular region associated with sagging neck, can be conducted. Treating through localized heating of regions of the SMAS or other suspensory subcutaneous connective tissue structures to temperatures of about 60-90° C., without significant damage to overlying or distal/underlying tissue, i.e., proximal tissue, as well as the precise delivery of therapeutic energy to SMAS regions, and obtaining feedback from the region of interest before, during, and after treatment can be suitably accomplished through
treatment system 100. - To further illustrate an exemplary method and
system 200, with reference toFIG. 2 , imaging of a region ofinterest 206, such as by imaging aregion 222 and displayingimages 224 of the region ofinterest 206 on adisplay 208, to facilitate localization of the treatment area and surrounding structures can initially be conducted. Next, delivery ofultrasound energy 220 at a suitably depth, distribution, timing, and energy level to achieve the desired therapeutic effect of thermal injury or ablation to treatSMAS region 216 can be suitably provided byprobe 204 through control bycontrol system 202. Monitoring of the treatment area and surrounding structures before, during, and after therapy, i.e., before, during, and after the delivery of ultrasound energy toSMAS region 216, can be provided to plan and assess the results and/or provide feedback to controlsystem 202 and a system user. - Ultrasound imaging and providing of
images 224 can facilitate safe targeting of theSMAS layer 216. For example, with reference toFIG. 2B , specific targeting for the delivery of energy can be better facilitated to avoid heating vital structures such as the facial nerve (motor nerve) 234, parotid gland (which makes saliva) 236,facial artery 238, and trigeminal nerve (for sensory functions) 232 among other regions. Further, use of imaging with targeted energy delivery to provide a limited and controlled depth of treatment can minimize the chance of damaging deep structures, such as for example, the facial nerve that lies below the parotid, which is typically 10 mm thick. - In accordance with an exemplary embodiment, with reference to
FIG. 2C , ultrasound imaging ofregion 222 of the region ofinterest 206 can also be used to delineateSMAS layer 216 as the superficial, echo-dense layer overlyingfacial muscles 218. Such muscles can be seen viaimaging region 222 by movingmuscles 218, for example by extensional flexing ofmuscle layer 218 generally towardsdirections region 222 may be further enhanced via signal and image processing. OnceSMAS layer 216 is localized and/or identified,SMAS layer 216 is ready for treatment. - The delivery of
ultrasound energy 220 at a suitably depth, distribution, timing, and energy level is provided byprobe 204 through controlled operation bycontrol system 202 to achieve the desired therapeutic effect of thermal injury to treatSMAS region 216. During operation, probe 204 can also be mechanically and/or electronically scanned withintissue surface region 226 to treat an extended area. In addition, spatial control of atreatment depth 220 can be suitably adjusted in various ranges, such as between a wide range of approximately 0 to 15 mm, suitably fixed to a few discrete depths, with an adjustment limited to a fine range, e.g. approximately between 3 mm to 9 mm, and/or dynamically adjusted during treatment, to treatSMAS layer 216 that typically lies at a depth between approximately 5 mm to 7 mm. Before, during, and after the delivery of ultrasound energy toSMAS region 216, monitoring of the treatment area and surrounding structures can be provided to plan and assess the results and/or provide feedback to controlsystem 202 and a system user. - For example, in accordance with an exemplary embodiment, with additional reference to
FIG. 2D , ultrasound imaging ofregion 222 can be used to monitor treatment by watching the amount of shrinkage ofSMAS layer 216 in direction ofareas region 220. The onset of substantially immediate shrinkage ofSMAS layer 216 is detectable by ultrasound imaging ofregion 222 and may be further enhanced via image and signal processing. The monitoring of such shrinkage can be ideal because it can confirm the intended therapeutic goal of noninvasive lifting and tissue tightening; in addition, such monitoring may be used for system feedback. In addition to image monitoring, additional treatment parameters that can be suitably monitored in accordance with various other exemplary embodiments may include temperature, video, profilometry, strain imaging and/or gauges or any other suitable spatial, temporal and/or other tissue parameters. - For example, in accordance with an exemplary embodiment of the present invention, with additional reference to
FIG. 2E , an exemplary monitoring method andsystem 200 may suitably monitor the temperature profile or other tissue parameters of the region ofinterest 206, such as attenuation or speed of sound oftreatment region 222 and suitably adjust the spatial and/or temporal characteristics and energy levels of ultrasoundtherapy transducer probe 204. The results of such monitoring techniques may be indicated ondisplay 208 in various manners, such as, for example, by way of one-, two-, or three-dimensional images ofmonitoring results 270, or may comprise anindicator 272, such as a success, fail and/or completed/done type of indication, or combinations thereof. - In accordance with another exemplary embodiment, with reference to
FIG. 2F , the targeting ofparticular region 220 withinSMAS layer 216 can be suitably be expanded within region ofinterest 206 to include a combination of tissues, such asskin 210,dermis 212, fat/adipose tissue 214, SMAS/muscular fascia/and/or othersuspensory tissue 216, andmuscle 218. Treatment of a combination of such tissues and/or fascia may be treated including at least one ofSMAS layer 216 or other layers of muscular fascia in combination with at least one of muscle tissue, adipose tissue, SMAS and/or other muscular fascia, skin, and dermis, can be suitably achieved bytreatment system 200. For example, treatment ofSMAS layer 216 may be performed in combination with treatment ofdermis 280 by suitable adjustment of the spatial and temporal parameters ofprobe 204 withintreatment system 200. - An
exemplary control system 202 anddisplay system 208 may be configured in various manners for controlling probe and system functionality. With reference toFIGS. 3A and 3B , in accordance with exemplary embodiments, anexemplary control system 300 can be configured for coordination and control of the entire therapeutic treatment process for noninvasive face lifts and deep tissue tightening. For example,control system 300 can suitably comprisepower source components 302, sensing andmonitoring components 304, cooling and coupling controls 306, and/or processing andcontrol logic components 308.Control system 300 can be configured and optimized in a variety of ways with more or less subsystems and components to implement the therapeutic system for controlled thermal injury, and the embodiments inFIGS. 3A and 3B are merely for illustration purposes. - For example, for
power sourcing components 302,control system 300 can comprise one or more direct current (DC)power supplies 303 configured to provide electrical energy forentire control system 300, including power required by a transducer electronic amplifier/driver 312. A DCcurrent sense device 305 can also be provided to confirm the level of power going into amplifiers/drivers 312 for safety and monitoring purposes. - Amplifiers/
drivers 312 can comprise multi-channel or single channel power amplifiers and/or drivers. In accordance with an exemplary embodiment for transducer array configurations, amplifiers/drivers 312 can also be configured with a beamformer to facilitate array focusing. An exemplary beamformer can be electrically excited by an oscillator/digitally controlledwaveform synthesizer 310 with related switching logic. - The power sourcing components can also include
various filtering configurations 314. For example, switchable harmonic filters and/or matching may be used at the output of amplifier/driver 312 to increase the drive efficiency and effectiveness.Power detection components 316 may also be included to confirm appropriate operation and calibration. For example, electric power and otherenergy detection components 316 may be used to monitor the amount of power going to an exemplary probe system. - Various sensing and
monitoring components 304 may also be suitably implemented withincontrol system 300. For example, in accordance with an exemplary embodiment, monitoring, sensing andinterface control components 324 may be configured to operate with various motion detection systems implemented withintransducer probe 204 to receive and process information such as acoustic or other spatial and temporal information from a region of interest. Sensing and monitoring components can also include various controls, interfacing andswitches 309 and/orpower detectors 316. Such sensing andmonitoring components 304 can facilitate open-loop and/or closed-loop feedback systems withintreatment system 200. - Cooling/
coupling control systems 306 may be provided to remove waste heat from anexemplary probe 204, provide a controlled temperature at the superficial tissue interface and deeper into tissue, and/or provide acoustic coupling fromtransducer probe 204 to region-of-interest 206. Such cooling/coupling control systems 306 can also be configured to operate in both open-loop and/or closed-loop feedback arrangements with various coupling and feedback components. - Processing and
control logic components 308 can comprise various system processors anddigital control logic 307, such as one or more of microcontrollers, microprocessors, field-programmable gate arrays (FPGAs), computer boards, and associated components, including firmware andcontrol software 326, which interfaces to user controls and interfacing circuits as well as input/output circuits and systems for communications, displays, interfacing, storage, documentation, and other useful functions. System software andfirmware 326 controls all initialization, timing, level setting, monitoring, safety monitoring, and all other system functions required to accomplish user-defined treatment objectives. Further,various control switches 308 can also be suitably configured to control operation. - An
exemplary transducer probe 204 can also be configured in various manners and comprise a number of reusable and/or disposable components and parts in various embodiments to facilitate its operation. For example,transducer probe 204 can be configured within any type of transducer probe housing or arrangement for facilitating the coupling of transducer to a tissue interface, with such housing comprising various shapes, contours and configurations.Transducer probe 204 can comprise any type of matching, such as for example, electric matching, which may be electrically switchable; multiplexer circuits and/or aperture/element selection circuits; and/or probe identification devices, to certify probe handle, electric matching, transducer usage history and calibration, such as one or more serial EEPROM (memories).Transducer probe 204 may also comprise cables and connectors; motion mechanisms, motion sensors and encoders; thermal monitoring sensors; and/or user control and status related switches, and indicators such as LEDs. For example, a motion mechanism inprobe 204 may be used to controllably create multiple lesions, or sensing of probe motion itself may be used to controllably create multiple lesions and/or stop creation of lesions, e.g. for safety reasons ifprobe 204 is suddenly jerked or is dropped. In addition, an external motion encoder arm may be used to hold the probe during use, whereby the spatial position and attitude ofprobe 104 is sent to the control system to help controllably create lesions. Furthermore, other sensing functionality such as profilometers or other imaging modalities may be integrated into the probe in accordance with various exemplary embodiments. Moreover, the therapy contemplated herein can also be produced, for example, by transducers disclosed in U.S. application Ser. No. 10/944,499, filed on Sep. 16, 2004, entitled Method And System For Ultrasound Treatment With A Multi-Directional Transducer and U.S. application Ser. No. 10/944,500, filed on Sep. 16, 2004, and entitled System And Method For Variable Depth Ultrasound Treatment, both hereby incorporated by reference. - With reference to
FIGS. 4A and 4B , in accordance with an exemplary embodiment, atransducer probe 400 can comprise acontrol interface 402, atransducer 404,coupling components 406, and monitoring/sensing components 408, and/ormotion mechanism 410. However,transducer probe 400 can be configured and optimized in a variety of ways with more or less parts and components to provide ultrasound energy for controlled thermal injury, and the embodiment inFIGS. 4A and 4B are merely for illustration purposes. -
Control interface 402 is configured for interfacing withcontrol system 300 to facilitate control oftransducer probe 400.Control interface components 402 can comprise multiplexer/aperture select 424, switchableelectric matching networks 426, serial EEPROMs and/or other processing components and matching and probe usage information 430,cable 428 andinterface connectors 432. - Coupling
components 406 can comprise various devices to facilitate coupling oftransducer probe 400 to a region of interest. For example,coupling components 406 can comprise cooling andacoustic coupling system 420 configured for acoustic coupling of ultrasound energy and signals. Acoustic cooling/coupling system 420 with possible connections such as manifolds may be utilized to couple sound into the region-of-interest, control temperature at the interface and deeper into tissue, provide liquid-filled lens focusing, and/or to remove transducer waste heat.Coupling system 420 may facilitate such coupling through use of various coupling mediums, including air and other gases, water and other fluids, gels, solids, and/or any combination thereof, or any other medium that allows for signals to be transmitted between transduceractive elements 412 and a region of interest. In addition to providing a coupling function, in accordance with an exemplary embodiment,coupling system 420 can also be configured for providing temperature control during the treatment application. For example,coupling system 420 can be configured for controlled cooling of an interface surface or region betweentransducer probe 400 and a region of interest and beyond by suitably controlling the temperature of the coupling medium. The suitable temperature for such coupling medium can be achieved in various manners, and utilize various feedback systems, such as thermocouples, thermistors or any other device or system configured for temperature measurement of a coupling medium. Such controlled cooling can be configured to further facilitate spatial and/or thermal energy control oftransducer probe 400. - In accordance with an exemplary embodiment, with additional reference to
FIG. 11 , acoustic coupling and cooling 1140 can be provided to acoustically couple energy and imaging signals fromtransducer probe 1104 to and from the region ofinterest 1106, to provide thermal control at theprobe 1100 to region-of-interest interface (skin) 1110 and deeper into tissue, and to remove potential waste heat from the transducer probe atregion 1144. Temperature monitoring can be provided at the coupling interface via athermal sensor 1146 to provides a mechanism oftemperature measurement 1148 and control viacontrol system 1102 and athermal control system 1142. Thermal control may consist of passive cooling such as via heat sinks or natural conduction and convection or via active cooling such as with peltier thermoelectric coolers, refrigerants, or fluid-based systems comprised of pump, fluid reservoir, bubble detection, flow sensor, flow channels/tubing 1144 andthermal control 1142. - With continued reference to
FIG. 4 , monitoring andsensing components 408 can comprise various motion and/orposition sensors 416,temperature monitoring sensors 418, user control and feedback switches 414 and other like components for facilitating control bycontrol system 300, e.g., to facilitate spatial and/or temporal control through open-loop and closed-loop feedback arrangements that monitor various spatial and temporal characteristics. -
Motion mechanism 410 can comprise manual operation, mechanical arrangements, or some combination thereof. For example, amotion mechanism driver 322 can be suitably controlled bycontrol system 300, such as through the use of accelerometers, encoders or other position/orientation devices 416 to determine and enable movement and positions oftransducer probe 400. Linear, rotational or variable movement can be facilitated, e.g., those depending on the treatment application and tissue contour surface. -
Transducer 404 can comprise one or more transducers configured for treating of SMAS layers and targeted regions.Transducer 404 can also comprise one or more transduction elements and/orlenses 412. The transduction elements can comprise a piezoelectrically active material, such as lead zirconate titanate (PZT), or any other piezoelectrically active material, such as a piezoelectric ceramic, crystal, plastic, and/or composite materials, as well as lithium niobate, lead titanate, barium titanate, and/or lead metaniobate. In addition to, or instead of, a piezoelectrically active material,transducer 404 can comprise any other materials configured for generating radiation and/or acoustical energy.Transducer 404 can also comprise one or more matching layers configured along with the transduction element such as coupled to the piezoelectrically active material. Acoustic matching layers and/or damping may be employed as necessary to achieve the desired electroacoustic response. - In accordance with an exemplary embodiment, the thickness of the transduction element of
transducer 404 can be configured to be uniform. That is, atransduction element 412 can be configured to have a thickness that is substantially the same throughout. In accordance with another exemplary embodiment, the thickness of atransduction element 412 can also be configured to be variable. For example, transduction element(s) 412 oftransducer 404 can be configured to have a first thickness selected to provide a center operating frequency of approximately 2 kHz to 75 MHz, such as for imaging applications.Transduction element 412 can also be configured with a second thickness selected to provide a center operating frequency of approximately 2 to 400 MHz, and typically between 4 MHz and 15 MHz for therapy application.Transducer 404 can be configured as a single broadband transducer excited with at least two or more frequencies to provide an adequate output for generating a desired response.Transducer 404 can also be configured as two or more individual transducers, wherein each transducer comprises one or more transduction element. The thickness of the transduction elements can be configured to provide center-operating frequencies in a desired treatment range. -
Transducer 404 may be composed of one or more individual transducers in any combination of focused, planar, or unfocused single-element, multi-element, or array transducers, including 1-D, 2-D, and annular arrays; linear, curvilinear, sector, or spherical arrays; spherically, cylindrically, and/or electronically focused, defocused, and/or lensed sources. For example, with reference to an exemplary embodiment depicted inFIG. 5 ,transducer 500 can be configured as anacoustic array 502 to facilitate phase focusing. That is,transducer 500 can be configured as an array of electronic apertures that may be operated by a variety of phases via variable electronic time delays. By the term “operated,” the electronic apertures oftransducer 500 may be manipulated, driven, used, and/or configured to produce and/or deliver an energy beam corresponding to the phase variation caused by the electronic time delay. For example, these phase variations can be used to deliver defocusedbeams 508,planar beams 504, and/orfocused beams 506, each of which may be used in combination to achieve different physiological effects in a region ofinterest 510.Transducer 500 may additionally comprise any software and/or other hardware for generating, producing and/or driving a phased aperture array with one or more electronic time delays. -
Transducer 500 can also be configured to provide focused treatment to one or more regions of interest using various frequencies. In order to provide focused treatment,transducer 500 can be configured with one or more variable depth devices to facilitate treatment. For example,transducer 500 may be configured with variable depth devices disclosed in U.S. patent application Ser. No. 10/944,500, entitled “System and Method for Variable Depth Ultrasound”, filed on Sep. 16, 2004, having at least one common inventor and a common Assignee as the present application, and incorporated herein by reference. In addition,transducer 500 can also be configured to treat one or moreadditional ROI 510 through the enabling of sub-harmonics or pulse-echo imaging, as disclosed in U.S. patent application Ser. No. 10/944,499, entitled “Method and System for Ultrasound Treatment with a Multi-directional Transducer”, filed on Sep. 16, 2004, having at least one common inventor and a common Assignee as the present application, and also incorporated herein by reference. - Moreover, any variety of mechanical lenses or variable focus lenses, e.g. liquid-filled lenses, may also be used to focus and/or defocus the sound field. For example, with reference to exemplary embodiments depicted in
FIGS. 6A and 6B ,transducer 600 may also be configured with an electronic focusingarray 602 in combination with one ormore transduction elements 606 to facilitate increased flexibility in treatingROI 610.Array 602 may be configured in a manner similar totransducer 502. That is,array 604 can be configured as an array of electronic apertures that may be operated by a variety of phases via variable electronic time delays, for example, T1, T2 . . . Tj. By the term “operated,” the electronic apertures ofarray 602 may be manipulated, driven, used, and/or configured to produce and/or deliver energy in a manner corresponding to the phase variation caused by the electronic time delay. For example, these phase variations can be used to deliver defocused beams, planar beams, and/or focused beams, each of which may be used in combination to achieve different physiological effects inROI 610. -
Transduction elements 606 may be configured to be concave, convex, and/or planar. For example, in an exemplary embodiment depicted inFIG. 6A ,transduction elements 606 are configured to be concave in order to provide focused energy for treatment ofROI 610. Additional embodiments are disclosed in U.S. patent application Ser. No. 10/944,500, entitled “Variable Depth Transducer System and Method”, and again incorporated herein by reference. - In another exemplary embodiment, depicted in
FIG. 6B ,transduction elements 606 can be configured to be substantially flat in order to provide substantially uniform energy toROI 610. WhileFIGS. 6A and 6B depict exemplary embodiments withtransduction elements 604 configured as concave and substantially flat, respectively,transduction elements 604 can be configured to be concave, convex, and/or substantially flat. In addition,transduction elements 604 can be configured to be any combination of concave, convex, and/or substantially flat structures. For example, a first transduction element can be configured to be concave, while a second transduction element can be configured to be substantially flat. - With reference to
FIGS. 8A and 8B ,transducer 800 can be configured as single-element arrays, wherein a single-element 802, e.g., a transduction element of various structures and materials, can be configured with a plurality ofmasks 804, such masks comprising ceramic, metal or any other material or structure for masking or altering energy distribution fromelement 802, creating an array ofenergy distributions 808.Masks 804 can be coupled directly toelement 802 or separated by astandoff 806, such as any suitably solid or liquid material. - An
exemplary transducer 404 can also be configured as an annular array to provide planar, focused and/or defocused acoustical energy. For example, with reference toFIGS. 10A and 10B , in accordance with an exemplary embodiment, anannular array 1000 can comprise a plurality ofrings N. Rings electronic focus 1020 can be suitably moved along various depth positions, and can enable variable strength or beam tightness, while an electronic defocus can have varying amounts of defocusing. In accordance with an exemplary embodiment, a lens and/or convex or concave shapedannular array 1000 can also be provided to aid focusing or defocusing such that any time differential delays can be reduced. Movement ofannular array 1000 in one, two or three-dimensions, or along any path, such as through use of probes and/or any conventional robotic arm mechanisms, may be implemented to scan and/or treat a volume or any corresponding space within a region of interest. -
Transducer 404 can also be configured in other annular or non-array configurations for imaging/therapy functions. For example, with reference toFIGS. 10C-10F , a transducer can comprise animaging element 1012 configured with therapy element(s) 1014.Elements standoff 1024 or other matching layers, or any combination thereof. For example, with particular reference toFIG. 10F , a transducer can comprise animaging element 1012 having asurface 1028 configured for focusing, defocusing or planar energy distribution, withtherapy elements 1014 including a stepped-configuration lens configured for focusing, defocusing, or planar energy distribution. - In accordance with various exemplary embodiments of the present invention,
transducer 404 may be configured to provide one, two and/or three-dimensional treatment applications for focusing acoustic energy to one or more regions of interest. For example, as discussed above,transducer 404 can be suitably diced to form a one-dimensional array, e.g.,transducer 602 comprising a single array of sub-transduction elements. - In accordance with another exemplary embodiment,
transducer 404 may be suitably diced in two-dimensions to form a two-dimensional array. For example, with reference toFIG. 9 , an exemplary two-dimensional array 900 can be suitably diced into a plurality of two-dimensional portions 902. Two-dimensional portions 902 can be suitably configured to focus on the treatment region at a certain depth, and thus providerespective slices dimensional array 900 can provide a two-dimensional slicing of the image place of a treatment region, thus providing two-dimensional treatment. - In accordance with another exemplary embodiment,
transducer 404 may be suitably configured to provide three-dimensional treatment. For example, to provide-three dimensional treatment of a region of interest, with reference again toFIG. 1 , a three-dimensional system can comprise a transducer withinprobe 104 configured with an adaptive algorithm, such as, for example, one utilizing three-dimensional graphic software, contained in a control system, such ascontrol system 102. The adaptive algorithm is suitably configured to receive two-dimensional imaging, temperature and/or treatment or other tissue parameter information relating to the region of interest, process the received information, and then provide corresponding three-dimensional imaging, temperature and/or treatment information. - In accordance with an exemplary embodiment, with reference again to
FIG. 9 , an exemplary three-dimensional system can comprise a two-dimensional array 900 configured with an adaptive algorithm to suitably receive 904 slices from different image planes of the treatment region, process the received information, and then providevolumetric information 906, e.g., three-dimensional imaging, temperature and/or treatment information. Moreover, after processing the received information with the adaptive algorithm, the two-dimensional array 900 may suitably provide therapeutic heating to thevolumetric region 906 as desired. - In accordance with other exemplary embodiments, rather than utilizing an adaptive algorithm, such as three-dimensional software, to provide three-dimensional imaging and/or temperature information, an exemplary three-dimensional system can comprise a
single transducer 404 configured within a probe arrangement to operate from various rotational and/or translational positions relative to a target region. - To further illustrate the various structures for
transducer 404, with reference toFIG. 7 ,ultrasound therapy transducer 700 can be configured for a single focus, an array of foci, a locus of foci, a line focus, and/or diffraction patterns.Transducer 700 can also comprise single elements, multiple elements, annular arrays, one-, two-, or three-dimensional arrays, broadband transducers, and/or combinations thereof, with or without lenses, acoustic components, and mechanical and/or electronic focusing. Transducers configured as spherically focusedsingle elements 702,annular arrays 704, annular arrays withdamped regions 706, line focusedsingle elements 708, 1-Dlinear arrays 710, 1-D curvilinear arrays in concave or convex form, with or without elevation focusing 712, 2-D arrays 714, and 3-D spatial arrangements of transducers may be used to perform therapy and/or imaging and acoustic monitoring functions. For any transducer configuration, focusing and/or defocusing may be in one plane or two planes viamechanical focus 720,convex lens 722,concave lens 724, compound ormultiple lenses 726,planar form 728, or stepped form, such as illustrated inFIG. 10F . Any transducer or combination of transducers may be utilized for treatment. For example, an annular transducer may be used with an outer portion dedicated to therapy and the inner disk dedicated to broadband imaging wherein such imaging transducer and therapy transducer have different acoustic lenses and design, such as illustrated inFIG. 10C-10F . - Moreover,
such transduction elements 700 may comprise a piezoelectrically active material, such as lead zirconate titanate (PZT), or any other piezoelectrically active material, such as a piezoelectric ceramic, crystal, plastic, and/or composite materials, as well as lithium niobate, lead titanate, barium titanate, and/or lead metaniobate.Transduction elements 700 may also comprise one or more matching layers configured along with the piezoelectrically active material. In addition to or instead of piezoelectrically active material,transduction elements 700 can comprise any other materials configured for generating radiation and/or acoustical energy. A means of transferring energy to and from the transducer to the region of interest is provided. - In accordance with another exemplary embodiment, with reference to
FIG. 12 , anexemplary treatment system 200 can be configured with and/or combined with various auxiliary systems to provide additional functions. For example, anexemplary treatment system 1200 for treating a region ofinterest 1202 can comprise acontrol system 1206, aprobe 1204, and adisplay 1208.Treatment system 1200 further comprises anauxiliary imaging subsystem 1272 and/orauxiliary monitoring modality 1274 may be based upon at least one of photography and other visual optical methods, magnetic resonance imaging (MRI), computed tomography (CT), optical coherence tomography (OCT), electromagnetic, microwave, or radio frequency (RF) methods, positron emission tomography (PET), infrared, ultrasound, acoustic, or any other suitable method of visualization, localization, or monitoring of SMAS layers within region-of-interest 1202, including imaging/monitoring enhancements. Such imaging/monitoring enhancement for ultrasound imaging viaprobe 1204 andcontrol system 1206 could comprise M-mode, persistence, filtering, color, Doppler, and harmonic imaging among others; furthermore anultrasound treatment system 1270, as a primary source of treatment, may be combined with asecondary treatment subsystem 1276, including radio frequency (RF), intense pulsed light (IPL), laser, infrared laser, microwave, or any other suitable energy source. - In accordance with another exemplary embodiment, with reference to
FIG. 13 , treatment composed of imaging, monitoring, and/or therapy to a region of interest may be further aided, augmented, and/or delivered with passive oractive devices 1304 within the oral cavity. For example, if passive oractive device 1304 is a second transducer or acoustic reflector acoustically coupled to the cheek lining it is possible to obtain through transmission, tomographic, or round-trip acoustic waves which are useful for treatment monitoring, such as in measuring acoustic speed of sound and attenuation, which are temperature dependent; furthermore such a transducer could be used to treat and/or image. In addition an active, passive, or active/passive object 1304 may be used to flatten the skin, and/or may be used as an imaging grid, marker, or beacon, to aid determination of position. A passive oractive device 1304 may also be used to aid cooling or temperature control. Natural air in the oral cavity may also be used aspassive device 1304 whereby it may be utilized to as an acoustic reflector to aid thickness measurement and monitoring function. - The present invention has been described above with reference to various exemplary embodiments. However, those skilled in the art will recognize that changes and modifications may be made to the exemplary embodiments without departing from the scope of the present invention. For example, the various operational steps, as well as the components for carrying out the operational steps, may be implemented in alternate ways depending upon the particular application or in consideration of any number of cost functions associated with the operation of the system, e.g., various of the steps may be deleted, modified, or combined with other steps. These and other changes or modifications are intended to be included within the scope of the present invention, as set forth in the following claims.
Claims (21)
1. (canceled)
2. An ultrasound treatment system for noninvasive tissue tightening, the system comprising:
a control system;
a display; and
an ultrasound probe,
wherein the ultrasound probe comprises a housing,
wherein the housing contains an ultrasound imaging element, an ultrasound therapy element, and a motion mechanism,
wherein a portion of the housing is configured for acoustic coupling to a skin surface,
wherein the ultrasound imaging element is connected to the display and the control system,
wherein the motion mechanism is connected to the control system,
wherein the ultrasound imaging element is configured for imaging a region of interest under the skin surface, wherein the region of interest comprises a tissue, wherein the tissue comprises a superficial muscular aponeurosis system (SMAS) tissue,
wherein the display is configured to display an image of the region of interest,
wherein the ultrasound therapy element is configured for delivery of energy at a temperature sufficient to cause shrinkage of a plurality of collagen fibers in the SMAS tissue at a depth under the skin surface,
wherein the ultrasound therapy element is connected to the motion mechanism,
wherein the motion mechanism moves the ultrasound therapy element to form a plurality of thermal foci at the depth for tightening the tissue.
3. The system of claim 2 , wherein the control system comprises:
a microprocessor;
software;
an input device;
a power supply;
a communication device;
a motion mechanism control; and
an image processor,
wherein the ultrasound probe is connected to the control system via a cable.
4. The system of claim 3 , further comprising a multiplexer to control a plurality of transduction elements.
5. The system of claim 2 , wherein the control system comprises a spatial control and a temporal control, the spatial control and the temporal control controlling the delivery of energy at a temperature sufficient to cause shrinkage of a plurality of collagen fibers in the SMAS tissue at a depth under the skin surface.
6. The system of claim 2 , further comprising a user control switch to activate the ultrasound therapy element.
7. The system of claim 2 ,
wherein the therapy element is a single element that delivers ultrasound energy at a frequency of between 4 MHz to 15 MHz,
wherein the temperature sufficient to cause tightening of the tissue is 60° C. to 90° C.,
wherein the ultrasound therapy element is configured to deliver the energy within a range of 3 mm to 9 mm below the skin surface,
wherein the tightening of tissue leads to any one of a face lift, a treatment of laxity, and a treatment of sagging in the skin surface.
8. An ultrasound treatment system for noninvasive tissue tightening, the system comprising:
an ultrasound probe comprising a housing,
wherein the housing contains an ultrasound imaging element, an ultrasound therapy element, and a motion mechanism,
wherein a portion of the housing is configured for acoustic coupling to a skin surface,
a control system; and
a display,
wherein the ultrasound imaging element is in communication with the display,
wherein the ultrasound imaging element is configured for imaging a region of interest under the skin surface, wherein the region of interest comprises a tissue, wherein the tissue comprises a superficial muscular aponeurosis system (SMAS) tissue,
wherein the display is configured to display an image of the region of interest,
wherein the ultrasound therapy element is in communication with the control system,
wherein the ultrasound therapy element is configured for delivery of energy at a temperature sufficient to cause shrinkage of a plurality of collagen fibers in the SMAS tissue at a depth under the skin surface,
wherein the ultrasound therapy element is connected to a portion of the motion mechanism,
wherein the motion mechanism is in communication with the control system,
wherein the motion mechanism moves the ultrasound therapy element to form a plurality of thermal foci at the depth for tightening the tissue.
9. The system of claim 8 , further comprising a user control switch to activate the ultrasound imaging element.
10. The system of claim 8 , further comprising an acoustic coupler between the ultrasound probe and the skin surface.
11. The system of claim 8 , wherein the ultrasound imaging element and the ultrasound therapy element are in a combined transducer.
12. The system of claim 8 , wherein the ultrasound imaging element is separate from, and co-housed with, the ultrasound therapy element in the probe.
13. The system of claim 8 , wherein the therapy element is a spherically focused single element.
14. The system of claim 8 , wherein the motion mechanism is a linear motion mechanism for linear movement of the ultrasound therapy element to form the plurality of thermal foci along a line at the depth in the region of interest.
15. The system of claim 8 , wherein the motion mechanism is configured for any one of the group consisting of linear, rotational, and variable movement of the ultrasound therapy element.
16. The system of claim 8 , wherein the motion mechanism comprises an encoder for monitoring a position of the ultrasound therapy element on the motion mechanism in the housing of the probe.
wherein the therapy element is a single element that delivers ultrasound energy at a frequency of between 4 MHz to 15 MHz,
wherein the temperature sufficient to cause tightening of the tissue is 60° C. to 90° C.,
wherein the ultrasound therapy element is configured to deliver the energy within a range of 3 mm to 9 mm below the skin surface,
wherein the tightening of tissue leads to any one of a face lift, a treatment of laxity, and a treatment of sagging in the skin surface.
17. An ultrasound treatment system for noninvasive tissue tightening, the system comprising:
an ultrasound probe; and
a control system;
wherein the ultrasound probe comprises a housing,
wherein the housing contains an ultrasound therapy element and a motion mechanism,
wherein a portion of the housing is configured for acoustic coupling to a skin surface,
wherein the ultrasound therapy element is in communication with the control system,
wherein the motion mechanism is in communication with the control system,
wherein the ultrasound therapy element is configured for delivery of energy at a temperature sufficient to cause shrinkage of a plurality of collagen fibers in a superficial muscular aponeurosis system (SMAS) tissue at a depth under the skin surface,
wherein the ultrasound therapy element is connected to a portion of the motion mechanism,
wherein the motion mechanism moves the ultrasound therapy element to form a plurality of thermal foci at the depth for tightening the tissue.
18. The system of claim 17 ,
wherein the housing further comprises an ultrasound imaging element,
wherein the ultrasound imaging element is configured for imaging a region of interest under the skin surface, wherein the region of interest comprises a tissue, wherein the tissue comprises the SMAS tissue,
wherein the ultrasound imaging element is configured to image with an imaging frequency of between 2 MHz to 75 MHz, and
wherein the tightening of tissue leads to any one of a face lift, a treatment of laxity, and a treatment of sagging in the skin surface.
19. The system of claim 17 , wherein the ultrasound therapy element is configured to deliver the energy within a range of 3 mm to 9 mm below the skin surface,
wherein the tightening of tissue leads to any one of a face lift, a treatment of laxity, and a treatment of sagging in the skin surface.
20. The system of claim 17 , wherein the tightening of tissue leads to any one of a face lift, a treatment of laxity, and a treatment of sagging in the skin surface,
wherein the control system comprises:
a microprocessor;
software;
an input device;
a power supply;
a communication device;
a motion mechanism control; and
wherein the ultrasound probe is connected to the control system via a cable.
21. The system of claim 17 ,
wherein the ultrasound therapy element is configured to heat the tissue to 60° C. to 90° C.,
wherein the ultrasound therapy element is a single element that delivers ultrasound energy at a frequency of between 4 MHz to 15 MHz,
wherein the tightening of tissue leads to any one of a face lift, a treatment of laxity, and a treatment of sagging in the skin surface.
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US20130296700A1 (en) | 2013-11-07 |
US8690779B2 (en) | 2014-04-08 |
US20140188015A1 (en) | 2014-07-03 |
US20130281891A1 (en) | 2013-10-24 |
US11338156B2 (en) | 2022-05-24 |
US8690778B2 (en) | 2014-04-08 |
US20190366128A1 (en) | 2019-12-05 |
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