WO2021160917A1 - Aparato emisor de ultrasonidos para aplicación de tratamientos selectivos sobre tejido adiposo en procesos de remodelación / rejuvenecimiento corporal - Google Patents
Aparato emisor de ultrasonidos para aplicación de tratamientos selectivos sobre tejido adiposo en procesos de remodelación / rejuvenecimiento corporal Download PDFInfo
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- WO2021160917A1 WO2021160917A1 PCT/ES2021/070099 ES2021070099W WO2021160917A1 WO 2021160917 A1 WO2021160917 A1 WO 2021160917A1 ES 2021070099 W ES2021070099 W ES 2021070099W WO 2021160917 A1 WO2021160917 A1 WO 2021160917A1
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Classifications
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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
- 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
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N2007/0004—Applications of ultrasound therapy
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- 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
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- 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
- A61N2007/0034—Skin treatment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N2007/0047—Ultrasound therapy interstitial
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N2007/0073—Ultrasound therapy using multiple frequencies
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N2007/0078—Ultrasound therapy with multiple treatment transducers
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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
- A61N2007/025—Localised ultrasound hyperthermia interstitial
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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
- A61N2007/027—Localised ultrasound hyperthermia with multiple foci created simultaneously
Definitions
- the invention refers to an ultrasound emitting device for the application of selective treatments on hypodermic tissue (adipose tissue and connective tissue) in body remodeling / rejuvenation processes, contributing to the function to which it is intended, advantages and characteristics, which are described in detail below, which represent an improvement of the current state of the art.
- the object of the present invention lies, specifically, in an apparatus that, applicable to carry out body remodeling / rejuvenation processes, comprises an ultrasonic transducer that, in addition to an application means, is connected to electronic equipment that regulates its power electrical and acoustic with the particularity that the emitted acoustic field is a multifocal ultrasound of low intensity of acoustic field and low frequency that, with waveforms of variable amplitude, duty cycle and frequency, allows to be selective with the hypodermic tissue, in specifically, on the adipose cells producing / inducing a physiological lipolysis with structural change of the adipocyte reducing its hypertrophic state together with an increase in the density of the hypodermic connective tissue producing a physiological restructuring of the same without cell death defining what is called an involution in the elastosis of the dermo-hypodermic tissue.
- the field of application of the present invention is framed within the sector of the industry dedicated to the manufacture of devices for the performance of aesthetic / medical treatments and non-invasive body remodeling / rejuvenation, focusing particularly on the field of those that comprise technology of ultrasounds.
- the acoustic field generated by the transducer of ultrasound equipment in cellulite treatments or other non-invasive methods of body reshaping is generally focused or unfocused.
- FIG. 9-B shows shows the radiation map of a non-focused transducer. It can be seen that its radiation map is divided into two zones, depending on the distance to the transducer (4).
- ⁇ The area closest to the transducer (4) is called the near field or Fresnel area (10). In this area, the intensity of the acoustic field varies considerably as a function of distance, as can be seen in the graph in Figure 9-B.
- the area farthest from the transducer (4) is called the far field or Fraunhofer area (11).
- the beginning of the far field zone is defined by the following equation where N is the distance where the far field zone begins, D is the diameter of the ultrasound generating element or transducer and l is the wavelength of the ultrasonic signal in the tissue.
- the intensity of the acoustic field is more uniform, but it decreases with distance.
- the objective of the present invention is, therefore, the development of an improved apparatus for the application of said ultrasound-based treatments that allows to obtain improved results without cell death and without risk of burns as it is a low intensity emitting equipment of acoustic field.
- This is due to a precise regulation of its transducer, and it should be noted that, at least by the applicant, the existence of any other apparatus, or any other invention of similar application, that presents the same technical and constitutive characteristics is unknown. similar to those specifically presented by the one claimed here. That is to say, a multifocalized equipment preferably with a low intensity of acoustic field and low emission frequency without cavitation phenomenon or hyperthermia or hypothermia.
- the ultrasound emitting device for the application of selective treatments on hypodermic adipose tissue in body remodeling / rejuvenation processes that the invention proposes is configured as the ideal solution to the aforementioned objective, the characterizing details that make it possible and distinguish it conveniently are included in the final claims accompanying the present description.
- the ultrasound emitting apparatus for the application of selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes object of the invention is characterized in that the acoustic field generated by the transducer is multifocalized.
- Figure 9-C shows a radiation field produced by a multifocalized transducer, where the existence of multiple radiation sources is observed and how these sources alternate with areas of low acoustic pressure.
- the advantages of this new emission mode are:
- the multiple sources of emission range from the epidermis to the hypodermis, acoustically affecting all layers of the skin.
- the multifocalized beam distributes energy over a wider area than the focused beam (Figure 9-A) and the unfocused beam ( Figure 9-B), both in depth and width, affecting a greater volume of tissue and therefore both reducing the energy density captured by the same tissue thus avoiding burns, increasing the physiological metabolism of adipose and connective tissue by entering into mechanical resonance without thermal effects with said tissues and inhibiting its adaptation and cell saturation.
- the multifocalized acoustic field makes it possible to work on edematous localized fat in large areas such as the abdomen or thighs, saddlebags, knees, arms, trochanter, etc. and to treat soft cellulite in practically all its stages, improving the appearance of the skin.
- the equipment by emitting in each shot an acoustic field with an acoustic field intensity not exceeding 0.7W / cm 2 and a minimum time duration of emission of 100ms producing or inducing on hypodermic tissue (adipose tissue and connective tissue) a physiological lipolysis with structural change of the adipocyte reducing its hypertrophic state together with an increase in the density of the hypodermic connective tissue producing a physiological restructuring of the same without cell death defining what is called an involution in the elastosis or aging of the dermo-hypodermic tissue.
- the way in which the apparatus of the invention delivers the energy produces a mechanical resonance through which a process of rejuvenation of the demo-hypodermic structures (adipose tissue and connective tissue) is achieved without the effect of cavitation or destruction of tissue, assuming a An effective non-invasive liposculpture alternative without side effects, which works in the deepest layer of the skin, evolving the elastosis state of the tissues, rejuvenating their state thanks to its low field intensity multifocalized ultrasound application technology acoustic and low frequency, which, likewise, also provides excellent results compacting tissue, reshaping the silhouette and stimulating the production of collagen in hypodermis, without pain or side effects. With this acoustic field intensity, a mechanical index of less than 0.5 is guaranteed, by means of which it is not possible to generate cavitation.
- the frequency of the electrical signal delivered to the transducer is in the range between 185 kHz and 333 kHz.
- This frequency range covers the 5th harmonic of the 37kHz frequency and the 7th harmonic of 45kHz.
- the adipocytes have their resonance frequency (depending on their diameter), making the adipocytes resonate, but with a lower energy than that which would be obtained in the range of 37kHz to 45kHz, it is ensured the non-generation or explosion of gas bubbles, thus avoiding the phenomenon of cavitation and the increase in surface temperature of the skin.
- the zone of maximum acoustic field intensity is at a depth between 3 to 20mm, while when it is delivers a 333kHz frequency to the transducer, the focus moves to a depth of 20 to 50mm.
- the depth of focus is changed and it is possible to cover a wide variety of therapeutic treatments such as the following:
- the first mode of operation consists of exciting the transducer at a single frequency, with the aim of selectively affecting adipocytes of a certain diameter.
- the frequency delivered to the transducer By varying the frequency delivered to the transducer, the user can vary the acoustic distribution of the ultrasound beam and the focus distance (where more energy is concentrated). This makes it possible to adapt the device to different treatments depending on the depth of focus.
- the frequency of this first operating mode is 224kHz, which allows a selective treatment of adipocytes with the most common diameter of hypodermic tissue with total control and absence of side effects on other tissues. More specifically, said frequency of the acoustic field provided by the transducer causes a mechanical resonance of the adipose tissue without effects of cavitation or hyperthermia or hypothermia.
- the second mode of operation consists of driving the transducer with a “chirp” signal, which is a variable frequency signal that sweeps the range of interest between 185kHz and 333kHz.
- a “chirp” signal which is a variable frequency signal that sweeps the range of interest between 185kHz and 333kHz.
- n refers to the number of pulses and f to the frequency of the salvo.
- the off time in each shot is at least 200ms. This off time is much higher than that used in existing equipment on the market where its off time does not exceed 20ms. This longer off time, compared to the competition, allows the circulatory system to evacuate the heat produced by the mechanical movement of adipocytes when affected by the ultrasound beam.
- the emitting apparatus fires shots with a duration of 2 seconds with a total of 10 ultrasound shots.
- a shot is understood as a followed by salvos together with their rest times or off times between salutes.
- This type of excitation guarantees a minimum number of mechanical movement on the adipocytes that induce a physiological lipolysis with structural change of the adipocytes, reducing their hypertrophic states together with an increase in the density of the hypodermic connective tissue, producing a physiological restructuring of the same without cell death. defining what is called an involution in the elastosis or aging of the dermo-hypodermic tissue.
- Figures 6, 7 and 8 the effects obtained with the apparatus of the invention can be observed.
- the first is to use a transducer with more than one piezoelectric element.
- the second alternative consists of inducing a lack of radiation symmetry of a single piezoelectric element by non-homogeneous bonding between the piezoelectric element and the cover that forms the transducer to guarantee only a finite series of radiation patterns (optimized for clinical results) and by using the chirp signal with which It is possible to vary the generation and composition of standing waves on the surface of the transducer cover, causing it to vibrate in different vibration modes, causing the radiation pattern to change as the frequency of the chirp increases in each shot, producing an effect similar to rotating the transducer, but without the need to rotate it.
- the device that the present invention proposes, thanks to the aforementioned emission of the multifocalized ultrasound beam and preferably its particular combination of low acoustic field intensity (less than 0.7 W / cm 2 ) and low frequency (range between 185kHz and 333kHz ) which represents an innovation for the reduction, compaction and elimination of localized fat, allowing total control of the depth of the energy deposit and selectivity of the target tissue or tissue to be treated, by adjusting the emission frequency, all without produce pain or side effects.
- low acoustic field intensity less than 0.7 W / cm 2
- low frequency range between 185kHz and 333kHz
- Figure number 1 shows a schematic representation of an example of the ultrasound emitting apparatus object of the invention, showing the main parts that it comprises;
- Figure number 2 - Shows, in a Cartesian axis graph, the radiation map or acoustic pressure field radiated by the transducer of the apparatus, according to the invention, excited with a frequency of 224kHz and an acoustic field intensity less than 0.7W / cm 2 , represented a longitudinal section of 50x50 mm with a resolution of 2mm;
- Figure number 3 - Shows another graph of the map of the acoustic pressure radiated by the transducer of the apparatus of the invention, in this case, excited with a frequency of 333kHz and an acoustic field intensity lower than 0.7W / cm 2 representing a longitudinal section 50x50mm with a resolution of 2mm;
- Figure number 4.- show the graph in Cartesian axes with resolution of 2mm, of the mechanical index calculated from the radiation pattern emitted by the transducer of
- Figure number 6. Shows an ultrasound section where, in the image on the left, the state of the hypodermic tissue of the lower abdomen is shown, where we can see the fibers of the connective tissue (in white) and the adipose tissue (in black) with a thickness that ranges from 0.5mm (deep dermis) to practically 30mm (Deep Fascia).
- One hour after the treatment, in the image on the Right we can see the effect of the technology causing a generalized compaction of the hypodermic tissue where a greater amount of connective tissue is observed (in white) and a redensification of the adipose tissue (between gray and black ) that will lead to the aforementioned tissue changes.
- Figure number 7 shows in the photo on the left, a patient prior to the treatment of the technology where fat accumulations and the marking of the folds in the lower back area can be seen due to the lack of consistency of the connective tissue due to the weight of adipose tissue.
- the photo on the Right after a month of the photo on the Left, we can observe the same patient (objectified by the multiple nevi on her back) with an ostensible reduction of fatty accumulations in the lower back area, as well as a very significant reduction in the folds of the treated area due to the compaction of the connective tissue.
- Figure 8 shows a histopathology performed using Masson's Trichrome and 6 immunostochemical markers (CD64, CD44, CD34, S100, Factor VIII and Alpha Actin) performed on a skin spindle prior to technology treatment (image on the left) and 14 days after the treatment of the technology (right image).
- Masson's Trichrome and 6 immunostochemical markers CD64, CD44, CD34, S100, Factor VIII and Alpha Actin
- a reduction (atrophy / involution) of the morphology of the adipose tissue to its physiological state is observed (from a hypertrophic state to a more physiological state)
- Figures 9-A, 9-B and 9-C show the radiation or beam patterns of a focused (Figure 9-A), unfocused (Figure 9-B) and multifocalized (Figure 9-C) ultrasound transducer.
- the apparatus (1) in question is one that basically comprises, conveniently housed in a protective support structure (2), at least one associated ultrasonic transducer (3) to some application means (4), to orient and direct the acoustic field on the area to be treated of the patient / user, with which, preferably, it is connected through a connection cable (5), and an electronic equipment of control (6) that, conveniently equipped with specific software, and through a screen (7) and / or a keyboard (8), allows to control its operation to regulate the intensity of the acoustic field, the duty cycle and excitation frequencies of said transducer (3).
- the ultrasound emitting apparatus for the application of selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes object of the invention is characterized in that the acoustic field generated by the transducer (3) is multifocalized.
- the transducer (3) emits an ultrasound beam of low intensity acoustic field (less than 0.7 W / cm 2 ) and low frequency that, between 185kHz and 333kHz, being 224kHz a frequency commonly used for treatments of single emission frequency.
- an oscilloscope is connected to the transducer terminals using a x10 divider probe. To gain access to the transducer terminals, the equipment was opened and two 50 cm long extension cables were connected to the terminals of the output terminal of the power Cl plate. The oscilloscope trigger is set to a single sweep and it proceeds to trigger and record various salvos with different settings on the control panel of the equipment.
- the amplitude of the excitation voltage is 177 Vrms, which generates an ultrasound beam in the transducer with an acoustic field intensity lower than 0.7W / cm 2 .
- the duration of the salvoes varies according to the value set on the control panel of the equipment. This value indicates the duration, in ms, of each salvo.
- acoustic field radiation measurements For acoustic field radiation measurements, coupling the transducer to be characterized on the side of a test tank filled with water.
- the acoustic energy propagates from the transducer into the tank, in the form of an acoustic field that is measured point by point by a hydrophone that moves inside the tank by means of a robotic mechanism.
- the measurements are made at low power, applying a voltage of 40 V peak to the transducer and scaling the measurements obtained to the equivalent values that would be obtained with the nominal voltage of 177 V rms.
- a computer with its own program is in charge of moving the transducer and acquiring the value of the acoustic field at each of the programmed points where the hydrophone stops to make the measurement.
- Measurements are first made at a nominal frequency of 224kHz, starting with a measurement in a 50x50 mm area, with a resolution of 2 mm, in the horizontal plane containing the transducer axis.
- Figures 2 show the acoustic field intensity (W / cm 2 ) of the ultrasonic beam radiated by the transducer of the excited apparatus with a frequency of 224 kHz and an acoustic field intensity lower than 0.7 W / cm 2 .
- the recorded data is stored forming a matrix that is processed and transformed using commercial software called MatLab ® (abbreviation of MATrix LABoratory, or matrix laboratory, consisting of a numerical computing system that offers an integrated development environment with a programming language own).
- MatLab ® abbreviation of MATrix LABoratory, or matrix laboratory, consisting of a numerical computing system that offers an integrated development environment with a programming language own.
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Abstract
Description
Claims
Priority Applications (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US17/758,845 US20230040937A1 (en) | 2020-02-13 | 2021-02-11 | Ultrasound-emitting apparatus for applying selective treatments to adipose tissue in body rejuvenation/remodelling processes |
MX2022008453A MX2022008453A (es) | 2020-02-13 | 2021-02-11 | Aparato emisor de ultrasonidos para aplicacion de tratamientos selectivos sobre tejido adiposo en procesos de remodelacion / rejuvenecimiento corporal. |
KR1020227023870A KR20220139296A (ko) | 2020-02-13 | 2021-02-11 | 신체 회춘/리모델링 과정에서 지방 조직에 선택적 치료를 적용하기 위한 초음파 방사 장치 |
BR112022015761A BR112022015761A2 (pt) | 2020-02-13 | 2021-02-11 | Aparelho emissor de ultrassom para aplicação de tratamentos seletivos em tecidos adiposos em processos de rejuvenescimento/remodelação corporal |
JP2022549246A JP2023513379A (ja) | 2020-02-13 | 2021-02-11 | 身体の若返り/再形成過程における脂肪組織への選択的処置のための超音波放射装置 |
EP21754038.4A EP4026586A4 (en) | 2020-02-13 | 2021-02-11 | ULTRASOUND TRANSMITTER DEVICE FOR THE APPLICATION OF SELECTIVE TREATMENTS ON FAT TISSUE IN BODY SHAPING/REJUVENATION PROCESSES |
CN202180014444.9A CN115103708A (zh) | 2020-02-13 | 2021-02-11 | 用于在身体年轻化/重塑过程中对脂肪组织进行选择性治疗的超声发射设备 |
CONC2022/0010805A CO2022010805A2 (es) | 2020-02-13 | 2022-08-01 | Aparato emisor de ultrasonidos para aplicación de tratamientos selectivos sobre tejido adiposo en procesos de remodelación / rejuvenecimiento corporal |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ESP202030122 | 2020-02-13 | ||
ES202030122A ES2793798B2 (es) | 2020-02-13 | 2020-02-13 | Aparato emisor de ultrasonidos para aplicacion de tratamientos selectivos sobre tejido adiposo en procesos de remodelacion / rejuvenecimiento corporal |
Publications (1)
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WO2021160917A1 true WO2021160917A1 (es) | 2021-08-19 |
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PCT/ES2021/070099 WO2021160917A1 (es) | 2020-02-13 | 2021-02-11 | Aparato emisor de ultrasonidos para aplicación de tratamientos selectivos sobre tejido adiposo en procesos de remodelación / rejuvenecimiento corporal |
Country Status (11)
Country | Link |
---|---|
US (1) | US20230040937A1 (es) |
EP (1) | EP4026586A4 (es) |
JP (1) | JP2023513379A (es) |
KR (1) | KR20220139296A (es) |
CN (1) | CN115103708A (es) |
AR (1) | AR121316A1 (es) |
BR (1) | BR112022015761A2 (es) |
CO (1) | CO2022010805A2 (es) |
ES (1) | ES2793798B2 (es) |
MX (1) | MX2022008453A (es) |
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JP2023513379A (ja) | 2023-03-30 |
EP4026586A1 (en) | 2022-07-13 |
CO2022010805A2 (es) | 2022-11-08 |
BR112022015761A2 (pt) | 2022-10-11 |
KR20220139296A (ko) | 2022-10-14 |
MX2022008453A (es) | 2022-08-02 |
ES2793798A1 (es) | 2020-11-16 |
AR121316A1 (es) | 2022-05-11 |
US20230040937A1 (en) | 2023-02-09 |
EP4026586A4 (en) | 2022-12-14 |
CN115103708A (zh) | 2022-09-23 |
ES2793798B2 (es) | 2022-04-29 |
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