WO2024229122A2 - Systèmes et procédés associés au remodelage du corps faisant intervenir une cavitation acoustique améliorée par laser - Google Patents

Systèmes et procédés associés au remodelage du corps faisant intervenir une cavitation acoustique améliorée par laser Download PDF

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WO2024229122A2
WO2024229122A2 PCT/US2024/027256 US2024027256W WO2024229122A2 WO 2024229122 A2 WO2024229122 A2 WO 2024229122A2 US 2024027256 W US2024027256 W US 2024027256W WO 2024229122 A2 WO2024229122 A2 WO 2024229122A2
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laser
ultrasound
hifu
adipose tissue
transducer
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WO2024229122A3 (fr
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Yannis Paulus
Xueding Wang
Xinmai Yang
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University of Kansas
University of Michigan System
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University of Kansas
University of Michigan System
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/203—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser applying laser energy to the outside of the body
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452—Skin
    • A61B2018/00458—Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
    • A61B2018/00464—Subcutaneous fat, e.g. liposuction, lipolysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A61B2018/00708—Power or energy switching the power on or off
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00994—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/26—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
    • A61B2018/263—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor for producing a shock wave, e.g. laser lithotripsy the conversion of laser energy into mechanical shockwaves taking place in a liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0093—Detecting, measuring or recording by applying one single type of energy and measuring its conversion into another type of energy
    • A61B5/0095—Detecting, measuring or recording by applying one single type of energy and measuring its conversion into another type of energy by applying light and detecting acoustic waves, i.e. photoacoustic measurements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0004—Applications of ultrasound therapy
    • A61N2007/0008—Destruction of fat cells

Definitions

  • Body sculpting or contouring is a procedure to reduce or eliminate excessive fat, shape areas of the body, and tighten skin.
  • Cryolipolysis or coolsculpting uses extreme cold to break down fat cells. The procedure is recommended only for people who are in good general health with no neurologic or orthopedic problems and who are looking for spot fat reduction in specific areas on the body. Cryolipolysis is not recommend for people who have obesity. Multiple sessions may be needed with 6-8 weeks between sessions. Skin surfaces may be irregular after healing.
  • An alternative, laser treatment works through the application of controlled heat to dismantle subcutaneous fat. Potential risks include infection, skin necrosis, dimpling, lumpiness, numbness, scarring, discoloration or sagging skin.
  • Ultrasonic cavitation or ultrasound cavitation, uses ultrasonic energy to break apart fat deposits.
  • An advantage of ultrasound cavitation is that it has an excellent safety profile.
  • existing ultrasonic cavitation system need improvement in efficiency of fat cell breakup. Improved systems and methods are needed to enhance the safety and efficiency of adipose tissue break up.
  • the present invention termed a laser-enhanced acoustic cavitation body sculpting (LAC-S), uses synchronized laser and ultrasound to enhance cavitation effect in optical absorptive materials.
  • LAC-S laser-enhanced acoustic cavitation body sculpting
  • an apparatus for performing synchronized laser and ultrasound treatment of adipose tissue may be specially constructed for the desired purposes, and/or it may comprise and integrate general-purpose instruments selectively activated or reconfigured (e.g., by a computer program) to carry out the methods described herein.
  • the computer program is stored in a non- transitory, tangible computer readable storage medium, or any type of media suitable for storing electronic instructions, which may be coupled to a computer having a processor.
  • any computing systems referred to in the specification may include a single processor or may be architectures employing multiple processor designs for increased computing capability.
  • the ultrasound is a high intensity focused ultrasound (HIFU) system such as an ExAblate 2000 (multielement phased-array transducer, 1.0—1.5 MHz frequency) or a Model JC unit (13.5 cm focal length and 0.8 MHz transducers).
  • HIFU high intensity focused ultrasound
  • the HIFU includes a piezoelectric ultrasound transducer.
  • the type of transducer used is a concave focusing transducer with a fixed aperture and focal length, a phased array transducer which comprises multiple piston transducers that are arranged on the truncated surface of a spherical bowl, or a flat transducer/fully populated phased array (e.g., Model -JC HIFU system, Chongqing HAIFUTM Company, Chongqing, China).
  • the HIFU system is guided, assessed, and monitored by a camera, sonography, magnetic resonance imaging (MRI), ultrasound imaging, or magnetic resonance-guided focused ultrasound (MRgFUS).
  • the mechanical movement of the transducer determines the position of the focal point, with electronic steering of the ultrasound beam allowing fine control of the focal spot location.
  • the mechanical movement of the HIFU system is controlled by software and/or coupled to a user interface, a transducer, multiple transducers, and/or a display.
  • the size of the transducer is variable.
  • the ultrasound is applied through an acoustic window on the target, by external or extracorporeal transducer, or by insertion of the transducer into the target.
  • the extracorporeal transducer has a wide aperture and long focal length.
  • the HIFU system operates through a frequency range of 20 KHz to 200 MHz and an amplitude range of 0.5 MPa to 5.5 MPa.
  • the laser is a pulsed nanosecond laser such as a diode-pumped solid -state (DPSS) type.
  • DPSS diode-pumped solid -state
  • the laser can produce approximately a 532 nm wavelength with pulse repetition frequency of approximately 10 Hz and pulse duration of approximately 3-5 ns.
  • the laser can generate a fixed laser pulse energy of approximately 50 mJ.
  • the ultrasound and laser systems and methods may be integrated in a number of different ways.
  • the laser system is triggered by a delay pulse generator (Model DG535, Stanford Research Systems, Sunnyvale, CA, USA).
  • a delay pulse generator is also used to trigger the HIFU system to temporally synchronize the ultrasound and laser pulses.
  • the trigger from delay pulse generator is supplied to a function generator (33250A, Agilent Technologies, Santa Clara, CA, US) to produce a 0.5 MHz sine wave burst.
  • the output burst from the function generator is first amplified by 50 dB through an RF amplifier (2100 L, Electronics & Innovation Ltd, Rochester, NY, US) and then passed to a HIFU transducer through an impedance matching circuit (Impedance Matching Network H107, Sonic Concepts, Bothell, WA, USA).
  • the HIFU transducer (H-107, Sonic Concepts, Bothell, WA, US) has a central frequency of 0.5 MHz and radius of curvature of 63.2 mm with focal depth and focal width of 21.42 mm and 3.02 mm, respectively.
  • the target and the HIFU transducer are submerged inside a water tank filled with degassed, deionized water such that the target is at the focal spot of the transducer.
  • the water tank size is variable and selected based on the subject treated and the area of treatment.
  • the laser beam is focused using a convex lens to result in a beam diameter of about 2 mm on the treatment area on the target.
  • the laser beam is passed through the hole in the center of the HIFU transducer and is spatially aligned with the HIFU focal region on the target before each treatment.
  • the laser induced photoacoustic wave from the target is detected using the 0.5 MHz HIFU transducer.
  • the wave is acquired on digital oscilloscope (TBS 2000B, Tektronix Inc., Beaverton, OR, USA).
  • the HIFU transducer is scanned across the target cross-section until the maximum photoacoustic signal is detected, indicating that the focal region of the HIFU transducer overlaid the laser spot on the target.
  • an ultrasound burst of 1000 cycles is repeated at 10 Hz (2% duty cycle) to minimize the effect of heat during the treatment.
  • each laser pulse is synchronized at the rarefactional phase of the ultrasound wave.
  • this is done by first precisely measuring the traveling time of the laser-induced photoacoustic (PA) wave propagating from the target to the HIFU transducer and then the time reversal of this PA wave propagation enables precise phase control when temporally synchronizing the laser pulses with the HIFU bursts.
  • PA laser-induced photoacoustic
  • the adipose tissue is positioned for targeting by ultrasound and laser.
  • the methods herein are not limited by the nature of the condition being treated.
  • the condition being treated is cellulite or excess adipose tissue.
  • the condition being treated is cancer or tissue growths.
  • the condition being treated is inflammation.
  • the condition being treated is neurodegenerative disease.
  • the condition being treated is chronic and non-malignant pain.
  • the methods herein are not limited by the identity or nature of the subject.
  • the subject being treated is an animal. More specifically, in some embodiments, the subject being treated a cat, dog, cow, pig, chicken, or non-human animal. In some embodiments, the subject being treated is a human. More specifically, in some embodiments, the subject being treated is a male or female. In some embodiments, the subject is an adult. In some embodiments, the subject is a juvenile.
  • the systems and methods employ one or more safety features.
  • the safety features provide for temperature control.
  • temperature control is managed using a temperature sensor (e.g., thermometer), a timer, and/or a temperature adjustment control mechanism, which can be operated automatically or manually.
  • the temperature adjustment control mechanism is embodied in software. In some embodiments, then an undesired temperature is detected by a sensor or camera, the temperature adjustment control mechanism alters one or more properties of the system or method, including, but not limited to, treatment cycle timing, on/off status, location of treatment, and the like.
  • the disclosed methods may further employ pharmacological and/or chemical agents, independently, or in conjunction, with the disclosed invention to treat the subject.
  • drugs are used in conjunction with the disclosed systems and methods.
  • a pain relieving drug is used in conjunction with the disclosed systems and methods.
  • a system that includes an ultrasound generator, a laser, and a controller that synchronizes ultrasound energy with laser energy.
  • the ultrasound generator is a high intensity focused ultrasound (HIFU) system and the laser is a pulsed nanosecond laser system and the controller is a delay pulse generator.
  • the laser is configured to generate a fixed laser pulse energy of 50 mJ and the HIFU system is configured to operate through an amplitude range of 0.98 MPa to 2.45 MPa.
  • the systems and methods herein comprise: a) a computer processor; b) non-transitory computer memory comprising one or more computer programs and/or a database, wherein the one or more computer programs configured to carry out one or more or all of: controlling the laser, controlling the ultrasound, receiving data from sensors, adjusting parameters based on sensor information, receiving user input, and providing user feedback.
  • FIG. 1 shows a schematic of the experimental setup. Detection of photoacoustic signal occurs at position 1 and HIFU treatment occurs at position 2.
  • FIGS. 2A-2F show pork belly fat samples after treatment with 9,000 ultrasound and/or laser pulses.
  • FIG. 2A shows a pork belly fat sample after ultrasound-only treatment.
  • FIG. 2B shows a pork belly fat sample after laser-only treatment.
  • FIG. 2C shows a pork belly fat sample after combined ultrasound and laser treatment.
  • FIG. 2D shows a magnified view of the left treated area in FIG. 2C.
  • FIG. 2E shows a magnified view of the right treated area in FIG. 2C.
  • FIG. 2F shows the pork belly fat parameters.
  • FIG. 3 shows the area of pork belly fat affected after treatment with 9,000 ultrasound and/or laser pulses with: 1) ultrasound PNP of 2.45 MPa; 2) laser pulse energy of 50 mJ; and 3) ultrasound PNP of 2.45 MPa and laser pulse energy of 50 mJ.
  • FIG. 4 shows the area of pork belly fat removed after treatment with 9,000 combined ultrasound and laser pulses.
  • Laser pulse energy was kept at 50 mJ and ultrasound PNP of 0.49, 0.98, 1.47, 1.96 and 2.45 MPa was used. p ⁇ 0.05; p ⁇ 0.01; p ⁇ 0.001.
  • FIG. 5 shows the area of pork belly fat removed after treatment with 9,000 combined ultrasound and laser pulses. Ultrasound PNP was fixed at 2.45 MPa and laser pulse energies of 10, 20, 30, 40 and 50 mJ were used. p ⁇ 0.05; p ⁇ 0.01; p ⁇ 0.001.
  • the term “and/or” includes any and all combinations of listed items, including any of the listed items individually.
  • “A, B, and/or C” encompasses A, B, C, AB, AC, BC, and ABC, each of which is to be considered separately described by the statement “A, B, and/or C.”
  • the term “comprise” and linguistic variations thereof denote the presence of recited feature(s), element(s), method step(s), etc. without the exclusion of the presence of additional feature(s), element(s), method step(s), etc.
  • the term “consisting of’ and linguistic variations thereof denotes the presence of recited feature(s), element(s), method step(s), etc. and excludes any unrecited feature(s), element(s), method step(s), etc., except for ordinarily-associated impurities.
  • the phrase “consisting essentially of’ denotes the recited feature(s), element(s), method step(s), etc. and any additional feature(s), element(s), method step(s), etc.
  • compositions, system, or method that do not materially affect the basic nature of the composition, system, or method.
  • Many embodiments herein are described using open “comprising” language. Such embodiments encompass multiple closed “consisting of’ and/or “consisting essentially of’ embodiments, which may alternatively be claimed or described using such language.
  • animal refers to any member of the animal kingdom. In some embodiments, “animal” refers to humans, at any stage of development. In some embodiments, “animal” refers to non-human animals, at any stage of development. In some embodiments, the non-human animal is a mammal (e.g., a rodent, a mouse, a rat, a rabbit, a monkey, a dog, a cat, a sheep, cattle, a primate, and/or a pig). In some embodiments, animals include, but are not limited to, mammals, birds, reptiles, amphibians, fish, and/or worms. In some embodiments, an animal may be a transgenic animal, genetically-engineered animal, and/or a clone.
  • mammal e.g., a rodent, a mouse, a rat, a rabbit, a monkey, a dog, a cat, a sheep, cattle, a primate, and/or a pig.
  • the term “approximately” and “about” is intended to encompass normal statistical variation as would be understood by those of ordinary skill in the art as appropriate to the relevant context.
  • the term “approximately” or “about” refers to a range of values that fall within 25%, 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, or less in either direction (greater than or less than) of the stated reference value unless otherwise stated or otherwise evident from the context (except where such number would exceed 100% of a possible value).
  • a patient refers to a human or any non-human animal (e.g., mouse, rat, rabbit, dog, cat, cattle, swine, sheep, horse or primate) to whom therapy is administered.
  • a patient is a human.
  • processor and “central processing unit” or “CPU” are used interchangeably and refer to a device that is able to read a program from a computer memory (e.g., ROM or other computer memory) and perform a set of steps according to the program.
  • a computer memory e.g., ROM or other computer memory
  • computer memory and “computer memory device” refer to any storage media readable by a computer processor.
  • Examples of computer memory include, but are not limited to, RAM, ROM, computer chips, digital video discs (DVD), compact discs (CDs), hard disk drives (HDD), optical discs, and magnetic tape.
  • the computer memory and computer processor are part of a non- transitory computer (e.g., in the control unit).
  • non-transitory computer readable media is employed, where non-transitory computer-readable media comprises all computer-readable media with the sole exception being a transitory, propagating signal.
  • computer readable medium refers to any device or system for storing and providing information (e.g., data and instructions) to a computer processor.
  • Examples of computer readable media include, but are not limited to, DVDs, CDs, hard disk drives, magnetic tape and servers for streaming media over networks, whether local or distant (e.g., cloud-based).
  • the term “in electronic communication” refers to electrical devices (e.g., computers, processors, etc.) that are configured to communicate with one another through direct or indirect signaling.
  • a computer configured to transmit (e.g., through cables, wires, infrared signals, telephone lines, airwaves, etc.) information to another computer or device, is in electronic communication with the other computer or device.
  • transmitting refers to the movement of information (e.g., data) from one location to another (e.g., from one device to another) using any suitable means.
  • FIG. 1 A detailed schematic of an exemplary setup is shown in FIG. 1.
  • the setup is a combination of a high intensity focused ultrasound (HIFU) system and a pulsed nanosecond laser system.
  • the laser system has a 532 nm wavelength (Surelite SL III- 10, Continuum, Santa Clara, CA, USA) with pulse repetition frequency of 10 Hz and pulse duration of 3-5 ns.
  • the laser system was triggered by a delay pulse generator (Model DG535, Stanford Research Systems, Sunnyvale, CA, USA). The same delay pulse generator was also used to trigger the HIFU to temporally synchronize the ultrasound and laser pulses.
  • the trigger from delay pulse generator was supplied to a function generator (33250A, Agilent Technologies, Santa Clara, CA, US) to produce a 0.5 MHz sine wave burst.
  • the output burst from the function generator was first amplified by 50 dB through an RF amplifier (2100 L, Electronics & Innovation Ltd, Rochester, NY, US) and then passed to a HIFU transducer through an impedance matching circuit (Impedance Matching Network H107, Sonic Concepts, Bothell, WA, USA).
  • the HIFU transducer (H-107, Sonic Concepts, Bothell, WA, US) has a central frequency of 0.5 MHz and radius of curvature of 63.2 mm with focal depth and focal width of 21.42 mm and 3.02 mm, respectively.
  • the sample and the HIFU transducer were submerged inside a water tank filled with degassed, deionized water such that the sample was at the focal spot of the transducer.
  • the laser beam was focused using a convex lens to result in a beam diameter of about 2 mm on the treatment area on the sample.
  • the laser beam was passed through the hole in the center of the HIFU transducer and was spatially aligned with the HIFU focal region on the sample before each treatment.
  • the laser induced photoacoustic wave from the sample was detected using the 0.5 MHz HIFU transducer.
  • the wave was acquired on digital oscilloscope (TBS 2000B, Tektronix Inc., Beaverton, OR, USA).
  • the HIFU transducer was scanned across the sample cross-section until the maximum photoacoustic signal was detected, indicating that the focal region of the HIFU transducer overlaid the laser spot on the target.
  • ultrasound burst of 1000 cycle was repeated at 10 Hz (2 % duty cycle) to minimize the effect of heat during the treatment.
  • Each laser pulse was precisely synchronized at the rarefactional phase of the ultrasound wave. This was done by first precisely measuring the traveling time of the laser- induced photoacoustic. (PA) wave propagating from the target to the HIFU transducer. Then the time reversal of this PA wave propagation enabled precise phase control when temporally synchronizing the laser pulses with the HIFU bursts as described previously [9], When detecting PA wave produced by 532 nm laser pulses, the produced PA signal was received by the HIFU transducer, and position 1 in FIG. 1 was connected.
  • PA laser- induced photoacoustic.
  • the treatment was carried out on pork belly fat samples to titrate the ultrasound and laser parameters for lipid removal.
  • the first few pork belly fat samples were treated with high peak negative pressure (PNP) ultrasound-only to find an ultrasound amplitude which did not result in any treatment effect on the sample. It was found that an ultrasound PNP of less than 2.94 MPa did not remove any lipids from the sample.
  • PNP peak negative pressure
  • an ultrasound PNP of less than 2.94 MPa and laser pulse energy of less than 60 mJ was used.
  • FIG. 2A-2F shows the pork belly fat samples treated with ultrasound-only, laser- only, and combined ultrasound and laser.
  • the ultrasound PNP amplitude of 2.45 MPa and laser pulse energy of 50 mJ (16 mJ/mm 2 ) was used for all the treatments.
  • the samples treated with combined ultrasound and laser resulted in fat tissue removal from the samples (Fig 2(c, d, e)).
  • the removal of fat tissue resulted in cavities on the sample surface.
  • the area of surface cavity after the treatment was used to assess the treatment effect.
  • FIG. 3 shows the cavity area on samples after the treatment with ultrasound-only, laser-only, and combined ultrasound and laser. Out of the four treatments carried out on samples using the laser-only, no cavity was observed in any case. For ultrasound-only, out of the four treatments, surface cavity of area 44 mm 2 was observed in only one treatment. In contrast, for the six treatments conducted using the combined ultrasound and laser, cavities were observed in all treatments with areas ranging from 105 mm 2 to 147 mm 2 and a mean cavity area of 124 mm 2 . The treatment area between the combined ultrasound and laser group and ultrasound/laser only group was statistically significant (p ⁇ 0.001).
  • FIG. 4A shows the results of the samples treated with combined ultrasound and laser at a fixed laser pulse energy, but different ultrasound PNPs.
  • the laser pulse energy was fixed at 50 mJ and ultrasound PNPs of 0.49, 0.98, 1.47, 1.96, and 2.45 MPa were used.
  • the mean cavity area of fat tissue removal after treatment generally increased with the increase in ultrasound PNP.
  • the mean cavity areas for 0.49, 0.98, 1.47, 1.96, and 2.45 MPa were 10, 0, 47, 72 and 124 mm 2 , respectively.
  • the areas of fat tissue removal were statistically significant between ultrasound PNP 0.98 MPa and 1.47 MPa (p ⁇ 0.01), 1.47 MPa and 1.96 MPa (p ⁇ 0.05), and 1.96 MPa and 2.45 MPa (p ⁇ 0.001).
  • FIG. 4B shows the results of the samples treated with combined ultrasound and laser at a fixed ultrasound PNP, but different laser pulse energy levels.
  • the ultrasound PNP was fixed at 2.45 MPa and laser pulse energies of 10, 20, 30, 40, and 50 mJ were used.
  • the mean cavity area of fat tissue removal after treatment generally increased with the increase in laser pulse energy.
  • the mean cavity areas of fat removal for 10, 20, 30, 40, and 50 mJ were 56, 70, 76, 70 and 124 mm 2 , respectively.
  • Statistical significance was achieved for areas of fat tissue removal between 10 mJ and 20 mJ (p ⁇ 0.05), 40 mJ and 50 mJ (p ⁇ 0.001), 10 mJ and 30 mJ (p ⁇ 0.01), and 30 mJ and 50 mJ (p ⁇ 0.001).

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Abstract

L'invention concerne des systèmes et des procédés qui utilisent un laser synchronisé et une énergie ultrasonore pour rompre un tissu adipeux. Les systèmes et le procédé sont utilisés pour l'élimination thérapeutique et/ou cosmétique du tissu adipeux.
PCT/US2024/027256 2023-05-01 2024-05-01 Systèmes et procédés associés au remodelage du corps faisant intervenir une cavitation acoustique améliorée par laser Ceased WO2024229122A2 (fr)

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US20150025420A1 (en) * 2004-10-06 2015-01-22 Guided Therapy Systems, Llc Ultrasound treatment device and methods of use
US10543123B2 (en) * 2008-04-28 2020-01-28 Joseph Neev Devices and methods for generation of subsurface micro-disruptions for opthalmic surgery and opthalmic applications
CN114577780B (zh) * 2022-03-04 2025-04-25 中国科学院合肥物质科学研究院 一种激光诱导击穿光谱增强检测装置及其检测方法

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