ULTRASOUND EMITTER DEVICE FOR APPLYING SELECTIVE TREATMENTS ON ADIPOSE TISSUE IN BODY REMODELING / REJUVENATION PROCESSES

Abstract

Ultrasound emitting device for applying selective treatments to hypodermic tissue (adipose and connective tissue) in rejuvenation and / or body contouring processes, comprising an electrical pulse generator, an ultrasonic transducer (3), an electronic control unit (6) equipped with specific software that controls the frequency, voltage, and duty cycle of the pulse generator, and application means (4) for orienting and directing the acoustic field onto the area to be treated on the patient / user, wherein said transducer emits in each pulse an acoustic field with an energy density not exceeding 0.7W / cm2 and a minimum emission duration of 100ms. Preferably, the transducer emits either at a single frequency or in a frequency sweep, in a frequency range between 185 kHz and 333 kHz, and even more preferably at 244 kHz.

Description

ULTRASOUND EMITTER DEVICE FOR APPLYING SELECTIVE TREATMENTS ON ADIPOSE TISSUE IN BODY REMODELING AND REJUVENATION PROCESSES DESCRIPTIVE MEMORANDUM OBJECT OF THE INVENTION The Invention, as expressed in the statement of this descriptive memorandum, 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, providing, to the function for which it is intended, advantages and characteristics, which are described in detail below, which represent an improvement over the current state of the art. The object of the present invention is, specifically, an apparatus that, applicable for carrying out body remodeling / rejuvenation processes, comprises an ultrasonic transducer that, in addition to an application means, is connected to an electronic device that regulates its electrical and acoustic power with the particularity that the emitted acoustic field is a multifocal ultrasound of low acoustic field intensity and low frequency which, with waveforms of variable amplitude, duty cycle and frequency, allows being selective with the hypodermic tissue, specifically on the adipose cells producing / inducing a physiological lipolysis with structural change of the adipocyte reducing its hypertrophic state along 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-hypodermal tissue. FIELD OF APPLICATION OF THE INVENTION The field of application of the present invention falls within the sector of the industry dedicated to the manufacture of devices intended for the performance of non-invasive aesthetic / medical treatments and body remodeling / rejuvenation, focusing particularly on the field of those comprising ultrasound technology. BACKGROUND OF THE INVENTION As a reference to the current state of the art, it should be noted that, although the use of ultrasound technology in cellulite reduction treatments or other non-invasive body remodeling methods is known, the devices currently available are based on focused ultrasound of high intensity acoustic field with the aim of achieving cavitation and cell death (destruction of adipocytes and connective tissue). The acoustic field generated by the transducer of ultrasound equipment in cellulite treatments or other non-invasive body contouring methods is generally focused or non-focused. Figure 9A shows the radiation map of a focused transducer, where all the energy is spatially concentrated at a point (9) called the focus, with the aim of causing lysis and therefore cell death. There are also, although less common, ultrasound devices used in cellulite treatments or other non-invasive body contouring methods that generate a non-focused acoustic field. Figure 9B shows the radiation map of a non-focused transducer. It can be observed that its radiation map is divided into two zones, depending on the distance from the transducer (4). The area closest to the transducer (4) is called the near field or Fresnel zone (10). In this zone, the acoustic field intensity varies considerably with distance, as shown in the graph in Figure 9B. The area farthest from the transducer (4) is called the far field or Fraunhofer zone (11). The beginning of the far field zone is defined by the following equation D2N= ü where N is the distance where the far field zone begins, D is the diameter of the ultrasound generating element or transducer and I is the wavelength of the ultrasonic signal in the tissue. In this area, the acoustic field intensity is more uniform, but it decreases with distance. The main drawback of this type of emission is that, within the near field zone, the radiation is very irregular and depends on the distance, as shown in the graph in Figure 9B. The objective of the present invention is, therefore, the development of an improved device for applying ultrasound-based treatments that allows for enhanced results without cell death and without risk of burns, as it is a low-intensity acoustic field emitter. This is achieved through precise regulation of its transducer. It should be noted that, at least to the applicant's knowledge, no other device or invention with a similar application is known to possess technical and structural characteristics identical or similar to those of the device claimed herein. That is to say, a multi-focused device, preferably with a low acoustic field intensity and low emission frequency, without cavitation, hyperthermia, or hypothermia. EXPLANATION OF THE INVENTION The ultrasound emitting device for applying selective treatments on adipose hypodermic tissue in body remodeling / rejuvenation processes that the invention proposes is configured as the ideal solution to the aforementioned objective, with the characterizing details that make it possible and distinguish it being conveniently included in the final claims that accompany this description. More specifically, what the invention proposes, as previously mentioned, is an apparatus applicable for carrying out remodeling / rejuvenation processes comprising: • an electrical pulse generator; • an ultrasonic transducer (3); • an electronic control unit (6) equipped with specific software that controls the frequency, voltage and duty cycle of the pulse generator; • application means (4) for orienting and directing the acoustic field onto the area to be treated of the patient / user. The ultrasound emitting device for applying selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes, the subject of the invention, is characterized in that the acoustic field generated by the transducer is multi-focused. Figure 9C shows a radiation field produced by a multifocused transducer, where multiple radiation foci are observed alternating with areas of low acoustic pressure. The advantages of this novel emission mode are: The multiple emission points extend from the epidermis to the hypodermis, acoustically affecting all layers of the skin. The multi-focused beam distributes energy over a wider area than both the focused beam (Figure 9A) and the unfocused beam (Figure 9B), both in depth and width, affecting a greater volume of tissue and therefore reducing the energy density absorbed by a single tissue. This prevents burns, increases the physiological metabolism of adipose and connective tissue by entering into mechanical resonance without thermal effects, and inhibits cellular adaptation and saturation. The multi-focused acoustic field allows for the treatment of localized edematous fat in large areas such as the abdomen, thighs, hips, knees, arms, trochanter, etc., and treats soft cellulite in virtually all its stages, improving the skin's appearance. • Multifocal emission allows for volumetric variation in tissue adaptation to prevent saturation of mechanosensitive cells (integrins, vincula, RAC1, Rho, etc.). Homogeneous emission would lead to tissue saturation, reducing the clinical effect. • By having a multi-focused beam, that is, alternating areas of acoustic pressure with others of low pressure, a decrease in metabolic stress is achieved, thus favoring the permeability of the cell membrane (enhancing the phenomenon of lipolysis), increasing the activity of the fibroblast, etc. The device, by emitting an acoustic field with an acoustic field intensity not exceeding 0.7W / cm2 and a minimum emission duration of 100ms in each shot, produces or induces physiological lipolysis on hypodermal tissue (adipose tissue and connective tissue) with a structural change of the adipocyte reducing its hypertrophic state along with an increase in the density of the hypodermal connective tissue producing a physiological restructuring of the same without cell death, defining what is called an involution in elastosis or aging of the dermohypodermal tissue. The way in which the device delivers energy produces a mechanical resonance that achieves a rejuvenation process of the dermal-hypodermal structures (adipose and connective tissue) without cavitation or tissue destruction. This represents an effective, non-invasive liposculpture alternative with no side effects. It works in the deepest layer of the skin, involuting the elastosis of the tissues and rejuvenating their condition thanks to its low-intensity, low-frequency, multi-focused ultrasound application technology. This technology also provides excellent results in compacting tissue, reshaping the silhouette, and stimulating collagen production in the hypodermis, without pain or side effects. This acoustic field intensity guarantees a mechanical index of less than 0.5, preventing cavitation. Preferably, the frequency of the electrical signal delivered to the transducer is between 185 kHz and 333 kHz. This frequency range covers the 5th harmonic of 37 kHz and the 7th harmonic of 45 kHz. Since the resonant frequency of adipocytes (which depends on their diameter) occurs between 37 kHz and 45 kHz, this range causes the adipocytes to resonate, but with less energy than would be obtained in the 37 kHz to 45 kHz range. This ensures that gas bubbles are not generated or burst, thus preventing cavitation and an increase in skin surface temperature. Varying the frequency of the electrical signal delivered to the transducer varies the depth of the zone of maximum acoustic field intensity. As examples, and as can be seen in figures 2 and 3, when a frequency of 224kHz is delivered to the transducer, the area of ​​maximum acoustic field intensity is located at a depth between 3 and 20mm, while when a frequency of 333kHz is delivered to the transducer, the focus shifts to a depth of between 20 and 50mm. By varying the frequency delivered to the transducer, the depth of focus is varied, making it possible to cover a wide variety of therapeutic treatments such as the following: - between 0.5mm - 15mm (areolar layer, always depending on the thickness of each patient) cellulite and compaction of connective tissue. - between 15mm - 30mm (lamellar layer, always depending on the thickness of each patient) localized fat and compaction of connective tissue. Two preferred operating modes are foreseen. The first operating mode involves exciting the transducer at a single frequency, selectively targeting adipocytes of a specific diameter. By varying the frequency delivered to the transducer, the user can alter the acoustic distribution of the ultrasound beam and the focal distance (where the energy is concentrated). This allows the device to be adapted to different treatments depending on the depth of focus. Preferably, the frequency for this first operating mode is 224 kHz, enabling selective treatment of adipocytes with the most common diameter in hypodermal tissue, with complete control and no side effects on other tissues. More specifically, this acoustic field frequency produced by the transducer induces mechanical resonance in the adipose tissue without cavitation, hyperthermia, or hypothermia. The second operating mode involves exciting the transducer with a "chirp" signal, a variable-frequency signal that covers the range of interest between 185 kHz and 333 kHz. This mode allows for targeting adipocytes of any diameter, representing a technological innovation of this device and offering significant advantages over competing equipment. Preferably, after each salvo (on time), the transmitting device has a rest period (off time). A salvo is understood to be an "on" period during which a pulse train is being emitted, the number of pulses of which depends on the on time itself and the frequency of said train, according to the following relationship: n = Ton * f Where n refers to the number of pulses and fa to the frequency of the burst. The off time between each pulse (sum of rest times after each burst) is at least 200 ms. This off time is significantly longer than that used in existing devices on the market, where the off time does not exceed 20 ms. This longer off time, compared to those of competitors, allows the circulatory system to dissipate the heat produced by the mechanical movement of adipocytes when affected by the ultrasound beam. CChQnn / 77Ω7 / Β / YILI Preferably, the emitting device delivers bursts lasting 2 seconds, for a total of 10 ultrasound bursts. A burst is defined as a sequence of bursts along with the rest periods or off periods between bursts. This type of excitation guarantees a minimum amount of mechanical movement on adipocytes, inducing physiological lipolysis with structural changes in the adipocytes, reducing their hypertrophic state and increasing the density of the hypodermal connective tissue. This produces a physiological restructuring of the tissue without cell death, defining what is known as an involution in elastosis or aging of the dermo-hypodermal tissue. Figures 6, 7, and 8 illustrate the effects obtained with the device of the invention. There are, among others, two possible alternatives to generate a multi-focused acoustic field. The first involves using a transducer with more than one piezoelectric element. The second alternative involves inducing a lack of radiation symmetry in a single piezoelectric element through non-homogeneous bonding between the element and the transducer's outer casing. This ensures a finite set of radiation patterns (optimized for clinical results) and utilizes a chirp signal to vary the generation and composition of standing waves on the transducer's casing surface. This causes the casing to vibrate in different modes, resulting in a changing radiation pattern with each shot as the chirp frequency increases. This produces an effect similar to transducer rotation, but without the actual rotation. This approach achieves greater efficiency because it insonates a larger area and, by generating an acoustic signal in the 185kHz to 333kHz range, causes adipocytes, regardless of their diameter, to vibrate in a single shot. In short, the device proposed by the present invention, thanks to the aforementioned emission of the multi-focused ultrasound beam and preferably its particular combination of low acoustic field intensity (less than 0.7 W / cm2) and low frequency (range between 185kHz and 333kHz), represents an innovation for the reduction, compaction and elimination of localized fat, allowing total control of the depth of energy deposit and selectivity of the target tissue or tissue to be treated, by adjusting the emission frequency, all without producing pain or side effects. DESCRIPTION OF THE DRAWINGS To complement the description being made and in order to help a better understanding of the characteristics of the invention, a drawing is attached to this descriptive document as an integral part thereof, in which the following has been represented for illustrative and non-limiting purposes: Figure 1 shows a schematic representation of an example of the ultrasound emitting apparatus that is the subject of the invention, showing the main parts 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 of less than 0.7W / cm2, representing a longitudinal section of 50x50 mm with a resolution of 2mm; Figure number 3 - Shows another graph of the acoustic pressure map radiated by the transducer of the apparatus of the invention, in this case excited with a frequency of 333kHz and an acoustic field intensity of less than 0.7W / cm2 representing a longitudinal section of 50x50mm with a resolution of 2mm; Figure number 4 shows the graph on Cartesian axes with a resolution of 2mm, of the mechanical index calculated from the radiation pattern emitted by the transducer of the apparatus, according to the invention, for a frequency of 224 kHz and an acoustic field power of less than 0.7W / cm2; Figure number 5.- Shows, again in a Cartesian axis graph, and resolution of 2mm, the mechanical index calculated from the radiation pattern emitted by the transducer of the apparatus, according to the invention, for a frequency of 330 kHz and an acoustic field power of less than 0.7W / cm2; Figure 6 shows an ultrasound scan where, in the image on the left, the state of the hypodermal tissue of the lower abdomen is shown. Here we can observe the connective tissue fibers (in white) and the adipose tissue (in black) with a thickness ranging from 0.5 mm (deep dermis) to almost 30 mm (deep fascia). One hour after treatment, in the image on the right, we can observe the effect of the technology, causing a generalized compaction of the hypodermal tissue. This shows a greater amount of connective tissue (in white) and a redensification of the adipose tissue (between gray and black), which will lead to the aforementioned tissue changes. Figure 7 shows, in the photo on the left, a patient before treatment with the technology, where fat deposits and pronounced folds in the lower back area can be seen due to the lack of firmness in the connective tissue caused by the weight of the adipose tissue. In the photo on the right, taken one month after the photo on the left, we can observe the same patient (identified by the multiple nevi on her back) with a noticeable reduction in fat deposits in the lower back area, as well as a very significant reduction in the folds characteristic of the treated area due to the compaction of the connective tissue. Figure 8 shows a histopathology performed using Masson's Trichrome and 6 immunochemical markers (CD64, CD44, CD34, S100, Factor VIII and Alpha Actin) performed on a cutaneous spindle prior to the technology treatment (left image) and 14 days after the technology treatment (right image). The following conclusions can be drawn from these images of the hypodermic tissue: - Dermis: notable decrease in macrochromatic elastotic fibers (tissue rejuvenation). - Hypodermis: No break in continuity (injury) is observed in the adipocyte membranes No macrophage contribution was observed in the analyzed area, therefore there is no coagulative necrosis (no lesion). - No vascular injury is observed A reduction (atrophy / involution) in the morphology of adipose tissue to its physiological state is observed (from a hypertrophic state to a more physiological state). A compaction of the adipose tissue and connective tissue is observed. Figures 9A, 9B, and 9C show the radiation or beam patterns of a focused (Figure 9A), unfocused (Figure 9B), and multifocused (Figure 9C) ultrasound transducer. PREFERRED EMBODIMENT OF THE INVENTION Thus, according to the schematic representation in Figure 1, the device (1) in question is one that basically comprises, conveniently housed in a protective support structure (2), at least an ultrasonic transducer (3) associated with application means (4) to orient and direct the acoustic field over the area to be treated of the patient / user, with which it is preferably connected through a connection cable (5), and an electronic control unit (6) which, conveniently equipped with specific software, and through a screen (7) and / or a keyboard (8), allows the control of its operation to regulate the intensity of the acoustic field, the duty cycle and excitation frequencies of said transducer (3). The ultrasound emitting device for applying selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes that is the subject of the invention is characterized in that the acoustic field generated by the transducer (3) is multi-focused. In a preferred embodiment, the transducer (3) emits a low acoustic field intensity (less than 0.7 W / cm2) and low frequency ultrasound beam between 185kHz and 333kHz, 224kHz being a frequency commonly used for single emission frequency treatments. As a demonstration of the effectiveness of said device / technology for the aforementioned treatment, different clinical tests have been carried out such as ultrasound scans, clinical photography and histopathology, figures 6, 7 and 8 respectively and a detailed study of the characterization of the acoustic field of the transducer under the aforementioned conditions, which, after carrying out electrical and acoustic radiation tests, provides the following results: For electrical measurement, an oscilloscope is connected to the transducer terminals using a x10 divider probe. To access the transducer terminals, the equipment was opened and two 50 cm long extension cables were connected to the terminals of the power IC board's output strip. The oscilloscope trigger is set to single sweep, and various bursts are triggered and recorded with different settings on the equipment's control panel. As a result, the following operating parameter values ​​are determined: - Each press of the trigger button located on the transducer produces 10 bursts of excitation voltage from the transducer, with a repetition period of 200 ms. - The excitation voltage amplitude is 177 Vrms, which generates an ultrasound beam in the transducer with an acoustic field intensity of less than 0.7W / cm2. - The duration of the salvos varies according to the value set on the equipment's control panel. This value indicates the duration, in milliseconds, of each salvo. To verify that the apparatus of the invention does not produce cavitation, the mechanical index (MI) of the radiation patterns shown in Figures 2 and 3 was calculated, giving Figures 4 and 5. This index was calculated using the expression shown below: P MI = Where P is the negative peak acoustic pressure in MPa and f is the center frequency of the ultrasound transducer's excitation signal in MHz. Therefore, according to reference [1], if MI is less than 0.5, cavitation does not occur. As can be seen in Figures 4 and 5, this index is less than 0.2, thus ensuring that the device of the invention does not produce cavitation. Acoustic field radiation measurements were performed by attaching the transducer to be characterized to the side of a water-filled test tank. Acoustic energy propagates from the transducer into the tank as an acoustic field, which is measured point by point by a hydrophone that moves inside the tank using a robotic mechanism. The measurements are performed at low power, applying a peak voltage of 40 V 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 responsible for moving the transducer and acquiring the value of the acoustic field at each of the programmed points where the hydrophone stops to take the measurement. Measurements are first taken at a nominal frequency of 224 kHz, starting with a measurement in a 50 x 50 mm area, with a resolution of 2 mm, in the horizontal plane containing the transducer axis. Figure 2 shows the acoustic field strength (W / cm²) of the ultrasonic beam radiated by the transducer of the device excited at a frequency of 224 kHz and an acoustic field strength of less than 0.7 W / cm². The acoustic field measurement was repeated at a frequency of 333 kHz, giving Figure 3. The recorded data is stored forming a matrix that is processed and transformed using commercial software called MatLab® (short for MATrix LABoratory, or matrix laboratory, consisting of a numerical computing system that offers an integrated development environment with its own programming language). - Regarding the measurement of acoustic radiation patterns: - Through controlled, non-homogeneous bonding, a lack of radiation symmetry is induced, achieving a multi-focusing phenomenon of the ultrasound beam, which can be varied by adjusting the emission frequency. As shown in Figures 2 and 3, by varying the excitation frequency from 224 kHz to 333 kHz, the zone of maximum acoustic field intensity has changed from a depth of 3 to 20 mm for the 224 kHz emission frequency to a depth of 20 to 50 mm for the 333 kHz frequency. In this way, it is possible to perform different treatments depending on the emission frequency. Having sufficiently described the nature of the present invention, as well as the manner of putting it into practice, it is not considered necessary to make its explanation more extensive so that any expert in the field can understand its scope and the advantages that derive from it.

Claims

1. - Ultrasound emitting apparatus for applying selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes, comprising: • an electrical pulse generator • an ultrasonic transducer (3), • an electronic control unit (6) equipped with specific software that controls the frequency, voltage and duty cycle of the pulse generator • application means (4), to orient and direct the acoustic field on the area to be treated of the patient / user, characterized in that the acoustic field generated by the transducer is multifocal. 2.- Ultrasound emitting device for applying selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes, according to claim 1 characterized in that said transducer emits in each shot an acoustic field with an energy density not exceeding 0.7W / cm2 and a minimum emission time of 100ms.

3. Ultrasound emitting apparatus for applying selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes, according to any of the previous claims, characterized in that said transducer emits in a frequency range between 185 kHz and 333 kHz.

4. Ultrasound emitting apparatus for applying selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes, according to any of the previous claims, characterized in that the transducer emits at a single frequency. 5.- Ultrasound emitting apparatus for applying selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes according to claim 4, characterized in that the transducer emits a single frequency of 224kHz. 6.- Ultrasound emitting device for applying selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes, according to any of claims 1-2, characterized in that the transducer emits at a frequency that varies throughout a single shot, sweeping the range of 185kHz and 333kHz.

7. Ultrasound emitting device for applying selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes, according to any of the previous claims, characterized in that after each burst there is a rest time (off time) the sum of the rest times being at least 200ms. 8.- Ultrasound emitting device for applying selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes, according to any of the previous claims, characterized in that each shot lasts 2 seconds with a total of 10 ultrasound bursts.

9. Ultrasound emitting apparatus for applying selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes, according to any of the previous claims, characterized in that the type of bonding between the piezoelectric element and the cover that forms the transducer is non-homogeneous. 10.- Ultrasound emitting apparatus for applying selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes, according to claim 1, characterized in that a chirp signal is used with which the generation and composition of standing waves on the surface of the transducer cover is varied. 11.- Ultrasound emitting apparatus for applying selective treatments on hypodermic tissue (adipose tissue and connective tissue) in rejuvenation and / or body remodeling processes according to any of the previous claims, characterized in that the transducer comprises more than one piezoelectric element.

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