WO2011077466A1 - Ultrasound device for treating cellulite and localized adiposity - Google Patents

Ultrasound device for treating cellulite and localized adiposity Download PDF

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Publication number
WO2011077466A1
WO2011077466A1 PCT/IT2009/000576 IT2009000576W WO2011077466A1 WO 2011077466 A1 WO2011077466 A1 WO 2011077466A1 IT 2009000576 W IT2009000576 W IT 2009000576W WO 2011077466 A1 WO2011077466 A1 WO 2011077466A1
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WO
WIPO (PCT)
Prior art keywords
handpiece
ultrasonic
waves
pressure
frequency
Prior art date
Application number
PCT/IT2009/000576
Other languages
French (fr)
Other versions
WO2011077466A8 (en
Inventor
Valerio Matano'
Egidio Tranfaglia
Original Assignee
Promoitalia Group S.Pa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Promoitalia Group S.Pa filed Critical Promoitalia Group S.Pa
Priority to BR112012015723A priority Critical patent/BR112012015723A2/en
Priority to PCT/IT2009/000576 priority patent/WO2011077466A1/en
Publication of WO2011077466A1 publication Critical patent/WO2011077466A1/en
Publication of WO2011077466A8 publication Critical patent/WO2011077466A8/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/008Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms using shock waves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/02Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive
    • A61H23/0245Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with ultrasonic transducers, e.g. piezoelectric
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00026Conductivity or impedance, e.g. of tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00084Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37Surgical systems with images on a monitor during operation
    • A61B2090/378Surgical systems with images on a monitor during operation using ultrasound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/065Light sources therefor
    • A61N2005/0651Diodes
    • A61N2005/0652Arrays of diodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/0658Radiation therapy using light characterised by the wavelength of light used
    • A61N2005/0659Radiation therapy using light characterised by the wavelength of light used infrared
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • A61N2007/0004Applications of ultrasound therapy
    • A61N2007/0008Destruction of fat cells

Definitions

  • the present invention relates to an esthetic medicine device for the treatment of cellulite, of localized adiposity, and of hirsutism.
  • fatty subcutaneous tissue is a tissue constituted by fibers and fat where the dermis (the skin layer that lies below the epidermis) and muscle are located. It constitutes the deepest layer of the skin and establishes a weak link between the skin and the inner organs that it covers. It performs substantially the functions of protecting deeper tissues against any traumas, of constituting an energy reserve and of limiting heat loss, helping to keep the body temperature constant.
  • Adipose tissue is formed substantially by adipocyte cells. These are cells which can synthesize and store triglycerides inside them. Adipocyte cells (or simply “adipocytes”) further tend to cluster together in lobules, forming the so-called “panniculus adiposus”.
  • cellulite consists substantially of an inflammation that affects the panniculus adiposus, causing an alteration thereof.
  • Said handpiece comprises a piezoelectric transducer, which is usually a piezoelectric disk or a quartz lamina.
  • the transducer is subjected to an alternating electrical field and converts the electrical signal generated by said field into decompression and compression waves, which are emitted into the biological tissues to be treated.
  • Another unfavorable element of currently commercially available devices consists in that the operator is forced to move the handpiece continuously with a rotary motion over the entire area involved, in order to facilitate drainage.
  • This mechanical massage is often exhausting, in view of the average weight of handpieces and of the average duration of the treatments, which is approximately 30 minutes for each treated area. Therefore, the operator often becomes tired and focuses the treatment on a single point.
  • the aim of the present invention is to provide an ultrasound device for treating cellulite and localized adiposity that overcomes the limitations of the background art.
  • an object of the invention is to provide a device that applies simultaneously Shockwaves and ultrasound to treat cellulite and localized adiposity which can simultaneously treat tissues, altered by said pathologies, located on different levels of the cutaneous layer.
  • Another object of the invention is to provide a device that applies simultaneously Shockwaves and ultrasound to treat cellulite and localized adiposity which is highly reliable, relatively easy to provide and at competitive costs.
  • a device that applies Shockwaves and ultrasound to treat cellulite and localized adiposity, comprising means for generating Shockwaves and ultrasonic waves with frequencies which can vary within a given range, said waves being emitted by at least one handpiece in contact with the region of the body to be treated, characterized in that it comprises means adapted to generate vibrations of said at least one handpiece for mechanical drainage of the tissue of said region of the body in contact with said at least one handpiece.
  • Figure 1 is a block diagram of the components of the ultrasound device for treating cellulite and localized adiposity, according to the invention
  • Figure 2 is a block diagram of the means for generating Shockwaves. Ways of carrying out the Invention
  • the device that applies Shockwaves and ultrasound for the treatment of cellulite and localized adiposity comprises means for generating pressure waves 2, wherein the pressure waves are emitted by means of at least one handpiece 3.
  • the handpiece 3 makes contact with the region of the body to be treated of the user 4, who supports said handpiece 3 for example by holding it in his hand.
  • the shockwave and ultrasound device 1 is provided with at least one handpiece 3.
  • the handpieces 3 are two in number, so that the user 4 can grip one for each hand.
  • the peculiarity of the ultrasound device 1 consists in that it comprises, in addition to the means for generating pressure waves 2, means 5 which are adapted to generate vibrations of said handpiece 3 in order to obtain mechanical drainage of the tissue of the region of the body in contact with the handpiece 3.
  • the means 2 for generating pressure waves comprise an electric voltage source 6 capable of generating an alternating electrical field 7.
  • This alternating electrical field 7 is sent, by way of adapted connection means, to a transducer 8 of a known type, which converts the electrical signal associated with the alternating electrical field 7 into ultrasonic pressure waves 9, i.e., waves with an ultrasonic frequency.
  • the frequency of the ultrasonic pressure waves 9 varies continuously for each pulse emitted by the electric voltage source 6.
  • the value of the amplitude of the alternating electrical field 7 produced by the voltage source 6 is adjusted and by doing so the frequency of the pressure waves 9 emitted by the transducer 8 is also modulated 1 ;
  • the pressure waves 9 comprise pulsed Shockwaves 9a and sinusoidal ultrasound waves 9b.
  • the Shockwaves 9a substantially have a pulsed behavior 9a with high pressure values, approximately 500 bars, and at high energy; in particular, the Shockwaves 9a are pressure pulses with an extremely rapid rising front, on the order of approximately ten billionths of a second, and very short rising and falling times.
  • the ultrasonic waves 9b have a sinusoidal behavior with pressure values of approximately 0.5 bar and allow to break up adipocyte walls without producing traumas at the tissue level; the Shockwaves 9a do not break up only the adipocytes, but everything they encounter along their passage, and for this reason they can be used only by trained medical personnel.
  • the Shockwaves 9a produce conspicuous and immediate results but have the drawbacks of forming fibrocystic tissue and of not being usable on patients that have a layer of fat of less than 2 centimeters.
  • the device 1 by way of adapted mechanical microsystems and piezoceramic and quartz components, allows to provide a synergy between the Shockwaves 9a and the ultrasonic waves 9b. This synergy allows to modulate and reduce the side effects of the Shockwaves 9a and to increase the effects of the ultrasonic waves 9b.
  • the device 1 according to the invention it is possible to select to use simultaneously the Shockwaves 9a and the ultrasonic waves 9b, or only the Shockwaves 9a or only the ultrasonic waves 9b.
  • the unit 10 for adjusting and controlling the electric voltage source 6 comprises a programmable microcontroller, which is managed by a man- machine interface means 11.
  • the man-machine interface means 11 can be constituted either by a monitor with a keyboard or for example by a screen of the touchscreen type.
  • the presence of the adjustment and control unit 6 allows to vary the frequencies of the ultrasound pressure waves 9b within a given range of low and high frequencies and also allows to alternate and pass rapidly and continuously from working with low frequencies to working with high frequencies and vice versa.
  • the frequencies of the ultrasonic pressure waves 9b can vary within a high frequency range substantially on the order of megahertz.
  • This type of application is adapted specifically for treating cellulite or edematous-fibrosclerotic panniculopathy, known by the acronym PEFS.
  • this pathology Since this pathology has a defect of microcirculation at the level of the superficial dermis, it requires a more superficial penetration of the ultrasonic pressure waves 9b and therefore the use of high frequencies is more appropriate.
  • the frequencies of the ultrasonic pressure waves 9b can also vary within a low frequency range, substantially on the order of kilohertz. This type of application is adapted particularly for treating excess localized adiposity, which by manifesting itself in the hypodermis requires a deeper penetration of the ultrasonic acoustic pressure waves 9 and therefore, in this case, a low frequency range is more appropriate.
  • the adiposity can have different densities in the same region depending on the layer, a variation of the frequency of the ultrasonic pressure waves 9b within the low frequency range is particularly useful.
  • the device 1 works both with low frequencies and with high frequencies of the ultrasonic pressure waves 9b, which alternate very rapidly.
  • the continuous sweeping of the f equencies within a given range and the alternation of the working intervals between low and high frequencies allows to affect both cellulite and localized adiposity as well as the mixed syndrome of adiposity and cellulite and simultaneously allows lymphatic drainage.
  • the means 5 adapted to produce vibrations of the handpiece 3 are inserted within the handpiece 3 and comprise an element, preferably shaped like a disk, which rotates about an axis that passes outside its center (also known as "off-center") or a programmer.
  • the ultrasound device 1 further comprises hydraulic cooling means 12, which make possible to cool the handpiece 3 and accordingly cool the region of the body of the user 4 that is in contact with the handpiece 3.
  • the ultrasound device 2 comprises in the handpiece 3 means with light emitting diodes 13 which produce infrared light.
  • the ultrasound device 1 further comprises pressure and roller means 14 for generating an endothermic massage which produces a suction effect on the tissue.
  • the pressure and roller means 14 can act in a low-speed pulsed action mode, preferably comprised between approximately 500 Hz and 1500 Hz, which is particularly effective in treating fibers, or in a mode of continuous action at high speed, comprised preferably between approximately 1700 Hz and 3000 Hz, which is particularly effective in reshaping loose skin in regions where a rapid reduction in adipose tissues has occurred.
  • a low-speed pulsed action mode preferably comprised between approximately 500 Hz and 1500 Hz, which is particularly effective in treating fibers, or in a mode of continuous action at high speed, comprised preferably between approximately 1700 Hz and 3000 Hz, which is particularly effective in reshaping loose skin in regions where a rapid reduction in adipose tissues has occurred.
  • the synergy of all the systems cited above, included in the device 1, facilitates the separation and redistribution of fat and blocks the adipose nodules of cellulite between the rollers.
  • the ultrasonic acoustic pressure waves 9 By using the ultrasonic acoustic pressure waves 9, besides performing a mechanical massage, a further electrical lysis of the fat in the tissues raised in vacuum is obtained.
  • the device 1 can be used with an ultrasonic imager
  • the device 1 can be used with an impedance meter
  • the device 1 can be used with a thermograph 17 in order to assess the extent and severity of the microcirculatory damage.
  • the thermographic plate is a plate that is similar to the plate of a normal X-ray image and is placed against the skin in order to detect skin temperature, which depends on vascularization and on the intensity of circulation flow.
  • the B-mode ultrasonic imager 15, the impedance meter 16 and the thermograph 17 communicate with the device 1 by means of a suitable software.
  • the ultrasound device 1 comprises means for avoiding loss of the calibration 18 of the handpiece 3. More particularly, the means for avoiding loss of calibration 18 are constituted by a digital potentiometer and by a microcontroller, which checks continuously the optimum frequency value of the ultrasonic acoustic pressure waves 9 emitted by the handpiece 3.
  • the device 1 can comprise depilation means 19, which act between the handpiece 3 and are adapted for treating hirsutism.
  • the depilation means 19 emit acoustic waves, with a frequency comprised substantially between approximately 10 kHz and 60 kHz, and ultrasound, with a frequency comprised substantially between approximately 3 kHz and 28 kHz, with a power substantially comprised between approximately 3 and 28 W.
  • the handpiece 3 provided with the depilation means 19 can be tweezer-shaped, so that the hair to be removed can be captured by the tweezers.
  • the ultrasound and the acoustic waves produce a vibration that is transferred to the hair and from there to the hair follicle. By doing so, a process of cavitation of the region that surrounds the hair follicle is also produced, causing an interruption thereof. This process is repeated for the individual hair follicles of the selected region of the body.
  • the handpiece 3 may not be tweezer-shaped but be provided with microballs which push the hair mechanically and focus the action of the acoustic and ultrasonic waves.
  • the depilation means 19 therefore allow, differently from conventional electrolysis, to strike with cavitation only the structures of the hair follicle that are associated with it and to minimize or eliminate completely the effect on adjacent tissues. By doing so, therefore, the possibility of scars, of bleeding and in general of the side effects that are present in other technologies, such as those using pulsed light or a laser, is eliminated. Moreover, the depilation means 19 can be used for any type of hair and for any skin tone, are safer and the pain produced is much lower.
  • the device for treating cellulite and localized adiposity according to the invention fully achieves the intended aim, since it allows to treat simultaneously tissues altered by cellulite and by localized adiposity that are present on different levels of the skin layer.
  • the possibility to provide a synergy between the ultrasonic pressure waves and the Shockwaves with a pulsed behavior allows to increase the effect of waves with a sinusoidal behavior, which are designed to break up the adipocyte walls without causing substantial traumas at the tissue level, and further allows to reduce the side effects of waves with pulsed behavior, which break up adipocytes and everything that they encounter along their passage.
  • the adjustment and control unit allows to vary the f equencies of the ultrasounds within a given range of both high and low f equencies allows to reach both the more superficial skin layers and the deeper ones, allows to treat pathologies located on different skin layers and allows to eliminate mixed forms of localized adiposity and cellulite and the different stages of cellulite.
  • the possibility to have a vibration of the handpiece allows to stimulate the muscles directly, without producing oxidative stress, which is a typical effect of intense muscle activity, and therefore without producing lactic acid, which is the basis of the unpleasant feeling of muscle "hardening” that often occurs after muscle exercise, particularly in scarcely exercised subjects.
  • these vibrations produce an improvement at the aesthetic level, activating circulation, providing greater blood supply to the cells and helping the body to expel toxins.
  • by producing a lymphatic drainage effect it helps the body to eliminate excess liquids and reduce swelling, and at the same time facilitates more efficient venous reflux, with a reduction of cellulite and a strengthening of the connective tissue that allows to achieve softer and smoother skin.
  • the mechanical drainage treatment performed synergistically and simultaneously with the cavitation treatment, obtained by means of the ultrasonic acoustic pressure waves, allows to increase the effects of the latter.
  • hydraulic cooling means which are capable of cooling the handpiece and therefore the tissue in contact with said handpiece helps to combat cellulite by reducing edemas and by stimulating blood circulation, since cooling applied to a given region stimulates the brain to send a larger amount of blood in order to maintain the thermal balance in the cooled tissues.
  • cooling allows to utilize fully the potential of ultrasonic acoustic pressure waves, since it attenuates the feelings of overheating of the tissues not only at the superficial level but also in depth, thus making the treatments always comfortable and eliminating the unpleasant painful sensation that is instead produced by other commercially available devices.
  • Another advantage of the device according to the invention consists in that it comprises means with light-emitting diodes which produce infrared light and, in addition to improving the effectiveness of the other systems with which the device is provided, allow to stimulate the lymphatic and blood system, in order to eliminate waste materials and interstitial liquid; allow stimulation of cell activity and regeneration and the production of collagen and elastin; and finally allow stimulation of the surface layers of the skin, in order to give the skin a more youthful appearance and combat the blemishes of cellulite, so-called "orange peel" skin.
  • inf ared light by releasing heat to a minimal extent at the surface and therefore concentrating the energy in depth, allows the hypothalamus to select the localized fat that is at the highest temperature.
  • a further advantage of the device according to the invention consists in that it combines synergistically the source of cold of the hydraulic cooling means and the sources of heat of the means for generating ultrasonic acoustic pressure waves and of the means with light-emitting diodes.
  • This synergy in addition to stimulation of the blood system, generates an internal "self-massage" of the tissues; in particular, the capillaries, the dermis and the muscles improve their condition by eliminating metabolic residues and accumulated stress.
  • Another advantage of the device according to the invention consists in that it comprises pressure and roller means for generating an endothermic massage which produces a suction effect on the tissue.
  • This suction massage is particularly effective, since it is powerful enough to aspirate a few centimeters of tissue by means of the handpiece, so as to mobilize the tissues and accordingly be able to break the hard fibers of cellulite.
  • the suction massage is also capable of performing a lymphatic drainage massage, so as to eliminate the toxins and metabolic waste residues through the lymphatic system.
  • a lymphatic drainage massage so as to eliminate the toxins and metabolic waste residues through the lymphatic system.
  • massage allies to increase the elasticity and flexibility of the skin and help to improve blemishes, such as "orange peel" skin.
  • the presence of a vibrating massage obtained by the means adapted to produce vibrations allows to increase the efficiency of the vacuum and to apply higher pressure of the fatty mass by means of the rollers of the pressure and roller means.
  • the device according to the invention can be interfaced with an ultrasonic imaging device, since it allows to capture ultrasonic images both before and directly after the treatment, thus being able to determine the extent and depth of cellulite lesions and to set the correct parameters on the shockwave and ultrasound device.
  • the device according to the invention can be interfaced with an impedance meter allows to evaluate, if needle electrodes are not used, the total, intracellular and extracellular body water percentage or to determine, if needle electrodes are used, the tissue resistivity of the specific regions to be treated.
  • thermograph allows to monitor therapeutic improvement and allows to assess the extent and severity of the microcirculatory damage easily, non-invasively and repeatably.
  • the device comprises means for avoiding loss of calibration allows to identify the optimum frequency of oscillation of the ultrasonic acoustic pressure waves emitted by each handpiece and therefore ensure maximum effectiveness of the treatments.
  • the device comprises a handpiece provided with depilation means that emit Shockwaves and ultrasounds that produce a cavitation process allows the treatment of hirsutism, avoiding side effects, damage to tissues adjacent to the hair follicle and allows greater safety, less pain and the possibility to be used with any type of hair and for any skin tone.
  • the materials used, as well as the dimensions, may be any according to requirements and to the state of the art.

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Abstract

A device (1) for treating cellulite and localized adiposity, as well as hirsutism, comprising means for generating Shockwaves and ultrasonic waves (2) with frequencies which can vary within a given range, said shockwaves and said ultrasonic waves being emitted by means of at least one handpiece (3) in contact with the region of the body to be treated, the device further comprising means (5) adapted to generate vibrations of the handpiece (3) in order to achieve mechanical drainage of the tissue of the region of the body to be treated in contact with the handpiece (3).

Description

ULTRASOUND DEVICE FOR TREATING CELLULITE AND LOCALIZED ADIPOSITY
Technical Field
The present invention relates to an esthetic medicine device for the treatment of cellulite, of localized adiposity, and of hirsutism.
Background Art
As is known, fatty subcutaneous tissue is a tissue constituted by fibers and fat where the dermis (the skin layer that lies below the epidermis) and muscle are located. It constitutes the deepest layer of the skin and establishes a weak link between the skin and the inner organs that it covers. It performs substantially the functions of protecting deeper tissues against any traumas, of constituting an energy reserve and of limiting heat loss, helping to keep the body temperature constant.
Adipose tissue is formed substantially by adipocyte cells. These are cells which can synthesize and store triglycerides inside them. Adipocyte cells (or simply "adipocytes") further tend to cluster together in lobules, forming the so-called "panniculus adiposus".
Etymologically, the term "cellulite" suggests a tissue pathology of inflammatory origin. Although this word is incorrect, it has entered ordinary language and is accepted by everyone to indicate a particular type of problem that affects the panniculus adiposus.
While the genesis of cellulite is still today a phenomenon that is not entirely clear and is therefore the focus of many studies, it is known, however, that cellulite consists substantially of an inflammation that affects the panniculus adiposus, causing an alteration thereof.
As a consequence of this alteration, an increase in the volume of the adipocytes occurs, with consequent transudation of liquids in the intercellular spaces. Cellulite, which is mainly widespread in females, is a true disease of tissues, which not only manifests itself in an unsightly manner but can also cause unpleasant pain and in any case constitute a general discomfort of the body.
As is known, it causes the surface of the skin to assume the characteristic "orange peel" or "mattress" appearance, exhibiting a number of more or less extensive bulges. The regions most affected are the hips, the buttocks and the thighs.
Several (non-invasive) methods are known f om ordinary literature for treating cellulite or more generally for reducing adipose tissue. Among these, ultrasonic hydrolipoclasia with cavitation effect has become established in recent years. This is a non-invasive therapeutic method for treating the pathology, which has the goal of reducing the volume of the adipose cells by using ultrasonic acoustic pressure waves, or "ultrasounds", i.e., pressure waves emitted with frequencies that are outside of the audibility range of the human ear. These ultrasounds are generated by means of electro-acoustic transducers: in particular, in this type of application, the ultrasounds are generated artificially by way of the characteristics of piezoelectric material. By applying an alternating electrical field to the faces of a piezoelectric material it is possible to obtain thereon an alternation of compressions and decompressions at very high frequencies, which generate a field of ultrasonic acoustic waves. These ultrasonic waves, by traveling through the tissues, transfer to them, by way of the known phenomenon of attenuation, part of their energy.
These waves produce within tissues, as is known in the background art, a physical phenomenon of "ultrasonic cavitation". This phenomenon occurs in a liquid subjected to a field of acoustic waves, when dynamic pressure decreases cause the local pressure to drop below the saturation pressure of the gases dissolved therein or the vapor pressure of the liquid itself. This situation entails, within the liquid, the generation of vapor in the form of minute bubbles, which expand during the decompression step, whereas in the subsequent compression step they implode, releasing impact energy into the tissues. This released energy damages the surrounding structures, contributing to the fragmentation of adipocyte cells.
Several devices are currently commercially available which are based on the principle of generation of pressure waves by cavitation effect. They are composed substantially of an apparatus, generally a handpiece, which is placed in contact with the part of the body to be treated.
Said handpiece comprises a piezoelectric transducer, which is usually a piezoelectric disk or a quartz lamina.
The transducer is subjected to an alternating electrical field and converts the electrical signal generated by said field into decompression and compression waves, which are emitted into the biological tissues to be treated.
However, these devices, as attested by the results observed directly on the patients, have variable and often disappointing results.
In most patients, only drainage of the liquids retained in the tissues is obtained, and said liquids accordingly tend to be replenished later in a simple manner.
This is due to the fixed frequencies that are used, which do not allow to act on all the blemishes that are present in the various levels of cutaneous tissue.
Existing devices in fact use either low-frequency ranges or high- frequency ranges. Low frequencies can always reach the same deep layers, whereas high frequencies can always reach the same more superficial layers. Therefore, it is not possible to treat, with a single application, the mixed pathologies of localized adiposity and cellulite.
Moreover, known devices are affected by the so-called "decalibration" phenomenon, i.e., loss of calibration of the handpiece. The technical solution that is currently most widespread for avoiding this problem is the use of pellets, which however do not always ensure the optimum resonance frequency.
Another unfavorable element of currently commercially available devices consists in that the operator is forced to move the handpiece continuously with a rotary motion over the entire area involved, in order to facilitate drainage. This mechanical massage is often exhausting, in view of the average weight of handpieces and of the average duration of the treatments, which is approximately 30 minutes for each treated area. Therefore, the operator often becomes tired and focuses the treatment on a single point.
Finally, another disadvantage of presently commercially available ultrasound apparatuses currently relates to the fact that they produce a heating of the tissue which can be unpleasant or painful.
Disclosure of the Invention
The aim of the present invention is to provide an ultrasound device for treating cellulite and localized adiposity that overcomes the limitations of the background art.
Within this aim, an object of the invention is to provide a device that applies simultaneously Shockwaves and ultrasound to treat cellulite and localized adiposity which can simultaneously treat tissues, altered by said pathologies, located on different levels of the cutaneous layer.
Another object of the invention is to provide a device that applies simultaneously Shockwaves and ultrasound to treat cellulite and localized adiposity which is highly reliable, relatively easy to provide and at competitive costs.
This aim, as well as these and other objects which will become better apparent hereinafter, are achieved by a device that applies Shockwaves and ultrasound to treat cellulite and localized adiposity, comprising means for generating Shockwaves and ultrasonic waves with frequencies which can vary within a given range, said waves being emitted by at least one handpiece in contact with the region of the body to be treated, characterized in that it comprises means adapted to generate vibrations of said at least one handpiece for mechanical drainage of the tissue of said region of the body in contact with said at least one handpiece.
Brief Description of the Drawings
Further characteristics and advantages of the invention will become better apparent from the description of a preferred but not exclusive embodiment of a device that applies simultaneously Shockwaves and ultrasound to treat cellulite and localized adiposity, illustrated by way of non-limiting example in the accompanying drawings, wherein:
Figure 1 is a block diagram of the components of the ultrasound device for treating cellulite and localized adiposity, according to the invention;
Figure 2 is a block diagram of the means for generating Shockwaves. Ways of carrying out the Invention
The device that applies Shockwaves and ultrasound for the treatment of cellulite and localized adiposity, generally designated by the reference numeral 1, comprises means for generating pressure waves 2, wherein the pressure waves are emitted by means of at least one handpiece 3.
The handpiece 3 makes contact with the region of the body to be treated of the user 4, who supports said handpiece 3 for example by holding it in his hand.
The shockwave and ultrasound device 1 is provided with at least one handpiece 3. Advantageously, the handpieces 3 are two in number, so that the user 4 can grip one for each hand.
The peculiarity of the ultrasound device 1 consists in that it comprises, in addition to the means for generating pressure waves 2, means 5 which are adapted to generate vibrations of said handpiece 3 in order to obtain mechanical drainage of the tissue of the region of the body in contact with the handpiece 3.
With reference to Figure 2, the means 2 for generating pressure waves comprise an electric voltage source 6 capable of generating an alternating electrical field 7. This alternating electrical field 7 is sent, by way of adapted connection means, to a transducer 8 of a known type, which converts the electrical signal associated with the alternating electrical field 7 into ultrasonic pressure waves 9, i.e., waves with an ultrasonic frequency. The frequency of the ultrasonic pressure waves 9 varies continuously for each pulse emitted by the electric voltage source 6.
Moreover, by means of an adjustment and control unit 10, the value of the amplitude of the alternating electrical field 7 produced by the voltage source 6 is adjusted and by doing so the frequency of the pressure waves 9 emitted by the transducer 8 is also modulated1;
The pressure waves 9 comprise pulsed Shockwaves 9a and sinusoidal ultrasound waves 9b. The Shockwaves 9a substantially have a pulsed behavior 9a with high pressure values, approximately 500 bars, and at high energy; in particular, the Shockwaves 9a are pressure pulses with an extremely rapid rising front, on the order of approximately ten billionths of a second, and very short rising and falling times.
The ultrasonic waves 9b have a sinusoidal behavior with pressure values of approximately 0.5 bar and allow to break up adipocyte walls without producing traumas at the tissue level; the Shockwaves 9a do not break up only the adipocytes, but everything they encounter along their passage, and for this reason they can be used only by trained medical personnel. The Shockwaves 9a produce conspicuous and immediate results but have the drawbacks of forming fibrocystic tissue and of not being usable on patients that have a layer of fat of less than 2 centimeters.
The device 1 according to the invention, by way of adapted mechanical microsystems and piezoceramic and quartz components, allows to provide a synergy between the Shockwaves 9a and the ultrasonic waves 9b. This synergy allows to modulate and reduce the side effects of the Shockwaves 9a and to increase the effects of the ultrasonic waves 9b.
Advantageously, in the device 1 according to the invention it is possible to select to use simultaneously the Shockwaves 9a and the ultrasonic waves 9b, or only the Shockwaves 9a or only the ultrasonic waves 9b.
The unit 10 for adjusting and controlling the electric voltage source 6 comprises a programmable microcontroller, which is managed by a man- machine interface means 11.
Conveniently, the man-machine interface means 11 can be constituted either by a monitor with a keyboard or for example by a screen of the touchscreen type.
All the above cited components that constitute the means for generating pressure waves 2 are well-known in the background art and accordingly are not described in detail.
The presence of the adjustment and control unit 6 allows to vary the frequencies of the ultrasound pressure waves 9b within a given range of low and high frequencies and also allows to alternate and pass rapidly and continuously from working with low frequencies to working with high frequencies and vice versa.
More particularly, the frequencies of the ultrasonic pressure waves 9b can vary within a high frequency range substantially on the order of megahertz. This type of application is adapted specifically for treating cellulite or edematous-fibrosclerotic panniculopathy, known by the acronym PEFS.
Since this pathology has a defect of microcirculation at the level of the superficial dermis, it requires a more superficial penetration of the ultrasonic pressure waves 9b and therefore the use of high frequencies is more appropriate.
However, since cellulite can have different stages in the same point, a variation of the frequency values within a given range of high frequencies is necessary, and in particular each stage requires a specific and different high frequency value.
The frequencies of the ultrasonic pressure waves 9b can also vary within a low frequency range, substantially on the order of kilohertz. This type of application is adapted particularly for treating excess localized adiposity, which by manifesting itself in the hypodermis requires a deeper penetration of the ultrasonic acoustic pressure waves 9 and therefore, in this case, a low frequency range is more appropriate.
Moreover, since the adiposity can have different densities in the same region depending on the layer, a variation of the frequency of the ultrasonic pressure waves 9b within the low frequency range is particularly useful.
The device 1 works both with low frequencies and with high frequencies of the ultrasonic pressure waves 9b, which alternate very rapidly. The continuous sweeping of the f equencies within a given range and the alternation of the working intervals between low and high frequencies allows to affect both cellulite and localized adiposity as well as the mixed syndrome of adiposity and cellulite and simultaneously allows lymphatic drainage.
Conveniently, the means 5 adapted to produce vibrations of the handpiece 3 are inserted within the handpiece 3 and comprise an element, preferably shaped like a disk, which rotates about an axis that passes outside its center (also known as "off-center") or a programmer.
The mechanical drainage treatment produced by way of the means 5 suitable to produce vibrations of the handpiece 3, performed synergistically and simultaneously with the cavitation treatment produced by way of the means for generating ultrasonic acoustic pressure waves 2, augments the effects of the latter and offers a far higher performance than the cavitation treatment alone.
Advantageously, the ultrasound device 1 further comprises hydraulic cooling means 12, which make possible to cool the handpiece 3 and accordingly cool the region of the body of the user 4 that is in contact with the handpiece 3.
Advantageously, the ultrasound device 2 comprises in the handpiece 3 means with light emitting diodes 13 which produce infrared light.
Advantageously, the ultrasound device 1 further comprises pressure and roller means 14 for generating an endothermic massage which produces a suction effect on the tissue.
The pressure and roller means 14 can act in a low-speed pulsed action mode, preferably comprised between approximately 500 Hz and 1500 Hz, which is particularly effective in treating fibers, or in a mode of continuous action at high speed, comprised preferably between approximately 1700 Hz and 3000 Hz, which is particularly effective in reshaping loose skin in regions where a rapid reduction in adipose tissues has occurred.
The synergy of all the systems cited above, included in the device 1, facilitates the separation and redistribution of fat and blocks the adipose nodules of cellulite between the rollers. By using the ultrasonic acoustic pressure waves 9, besides performing a mechanical massage, a further electrical lysis of the fat in the tissues raised in vacuum is obtained.
Advantageously, the device 1 can be used with an ultrasonic imager
15, for example of the B-mode type, by means of which it is possible to capture images both before and directly after treatment.
Advantageously, the device 1 can be used with an impedance meter
16, with and without needle electrodes. By inserting the impedance meter 16 prior to the treatment, an impedance measurement test is performed without needle electrodes which allows to analyze the body composition of the patient, assessing the percentage of total, intracellular and extracellular body water. By using the impedance meter 16 with needle electrodes it is possible to- determine the tissue resistivity of the specific regions to be treated.
Advantageously, the device 1 can be used with a thermograph 17 in order to assess the extent and severity of the microcirculatory damage. In particular, the thermographic plate is a plate that is similar to the plate of a normal X-ray image and is placed against the skin in order to detect skin temperature, which depends on vascularization and on the intensity of circulation flow.
In contact thermography, therefore, the difference in temperature between the examined region and the adjacent region, which acts as reference, becomes important.
Since cellulite is characterized by compromised microcirculation, in the thermographic image the cellulite regions which are scarcely vascularized will appear of a different color than the healthy neighboring regions.
The B-mode ultrasonic imager 15, the impedance meter 16 and the thermograph 17 communicate with the device 1 by means of a suitable software.
Conveniently, the ultrasound device 1 comprises means for avoiding loss of the calibration 18 of the handpiece 3. More particularly, the means for avoiding loss of calibration 18 are constituted by a digital potentiometer and by a microcontroller, which checks continuously the optimum frequency value of the ultrasonic acoustic pressure waves 9 emitted by the handpiece 3.
Advantageously, the device 1 can comprise depilation means 19, which act between the handpiece 3 and are adapted for treating hirsutism. The depilation means 19 emit acoustic waves, with a frequency comprised substantially between approximately 10 kHz and 60 kHz, and ultrasound, with a frequency comprised substantially between approximately 3 kHz and 28 kHz, with a power substantially comprised between approximately 3 and 28 W.
The handpiece 3 provided with the depilation means 19 can be tweezer-shaped, so that the hair to be removed can be captured by the tweezers. The ultrasound and the acoustic waves produce a vibration that is transferred to the hair and from there to the hair follicle. By doing so, a process of cavitation of the region that surrounds the hair follicle is also produced, causing an interruption thereof. This process is repeated for the individual hair follicles of the selected region of the body.
Conveniently, it is possible to provide on the handpiece 3 also a passage for dispensing a coolant for cooling the region of contact with the ultrasound.
As an alternative, the handpiece 3 may not be tweezer-shaped but be provided with microballs which push the hair mechanically and focus the action of the acoustic and ultrasonic waves.
The depilation means 19 therefore allow, differently from conventional electrolysis, to strike with cavitation only the structures of the hair follicle that are associated with it and to minimize or eliminate completely the effect on adjacent tissues. By doing so, therefore, the possibility of scars, of bleeding and in general of the side effects that are present in other technologies, such as those using pulsed light or a laser, is eliminated. Moreover, the depilation means 19 can be used for any type of hair and for any skin tone, are safer and the pain produced is much lower.
In practice it has been found that the device for treating cellulite and localized adiposity according to the invention fully achieves the intended aim, since it allows to treat simultaneously tissues altered by cellulite and by localized adiposity that are present on different levels of the skin layer.
In particular, the possibility to provide a synergy between the ultrasonic pressure waves and the Shockwaves with a pulsed behavior allows to increase the effect of waves with a sinusoidal behavior, which are designed to break up the adipocyte walls without causing substantial traumas at the tissue level, and further allows to reduce the side effects of waves with pulsed behavior, which break up adipocytes and everything that they encounter along their passage.
Moreover, the fact that the adjustment and control unit allows to vary the f equencies of the ultrasounds within a given range of both high and low f equencies allows to reach both the more superficial skin layers and the deeper ones, allows to treat pathologies located on different skin layers and allows to eliminate mixed forms of localized adiposity and cellulite and the different stages of cellulite.
Moreover, the possibility to have a vibration of the handpiece allows to stimulate the muscles directly, without producing oxidative stress, which is a typical effect of intense muscle activity, and therefore without producing lactic acid, which is the basis of the unpleasant feeling of muscle "hardening" that often occurs after muscle exercise, particularly in scarcely exercised subjects. Moreover, these vibrations produce an improvement at the aesthetic level, activating circulation, providing greater blood supply to the cells and helping the body to expel toxins. In fact, by producing a lymphatic drainage effect, it helps the body to eliminate excess liquids and reduce swelling, and at the same time facilitates more efficient venous reflux, with a reduction of cellulite and a strengthening of the connective tissue that allows to achieve softer and smoother skin.
The mechanical drainage treatment performed synergistically and simultaneously with the cavitation treatment, obtained by means of the ultrasonic acoustic pressure waves, allows to increase the effects of the latter.
Moreover, the fact that hydraulic cooling means are present which are capable of cooling the handpiece and therefore the tissue in contact with said handpiece helps to combat cellulite by reducing edemas and by stimulating blood circulation, since cooling applied to a given region stimulates the brain to send a larger amount of blood in order to maintain the thermal balance in the cooled tissues. Moreover, cooling allows to utilize fully the potential of ultrasonic acoustic pressure waves, since it attenuates the feelings of overheating of the tissues not only at the superficial level but also in depth, thus making the treatments always comfortable and eliminating the unpleasant painful sensation that is instead produced by other commercially available devices.
Another advantage of the device according to the invention consists in that it comprises means with light-emitting diodes which produce infrared light and, in addition to improving the effectiveness of the other systems with which the device is provided, allow to stimulate the lymphatic and blood system, in order to eliminate waste materials and interstitial liquid; allow stimulation of cell activity and regeneration and the production of collagen and elastin; and finally allow stimulation of the surface layers of the skin, in order to give the skin a more youthful appearance and combat the blemishes of cellulite, so-called "orange peel" skin.
Moreover, the use of inf ared light, by releasing heat to a minimal extent at the surface and therefore concentrating the energy in depth, allows the hypothalamus to select the localized fat that is at the highest temperature.
A further advantage of the device according to the invention consists in that it combines synergistically the source of cold of the hydraulic cooling means and the sources of heat of the means for generating ultrasonic acoustic pressure waves and of the means with light-emitting diodes. This synergy, in addition to stimulation of the blood system, generates an internal "self-massage" of the tissues; in particular, the capillaries, the dermis and the muscles improve their condition by eliminating metabolic residues and accumulated stress.
Another advantage of the device according to the invention consists in that it comprises pressure and roller means for generating an endothermic massage which produces a suction effect on the tissue.
This suction massage is particularly effective, since it is powerful enough to aspirate a few centimeters of tissue by means of the handpiece, so as to mobilize the tissues and accordingly be able to break the hard fibers of cellulite.
Moreover, the suction massage is also capable of performing a lymphatic drainage massage, so as to eliminate the toxins and metabolic waste residues through the lymphatic system. Moreover, such massage allies to increase the elasticity and flexibility of the skin and help to improve blemishes, such as "orange peel" skin.
Moreover, the presence of a vibrating massage obtained by the means adapted to produce vibrations allows to increase the efficiency of the vacuum and to apply higher pressure of the fatty mass by means of the rollers of the pressure and roller means.
Moreover, the synergistic use of these systems allows separation and redistribution of the fats and blocks the adipose nodules of cellulite between the rollers. By then using the ultrasonic acoustic pressure waves in addition to performing a mechanical massage, a further electrical lysis of the fats in the tissue raised in vacuum is achieved.
It is significant that the device according to the invention can be interfaced with an ultrasonic imaging device, since it allows to capture ultrasonic images both before and directly after the treatment, thus being able to determine the extent and depth of cellulite lesions and to set the correct parameters on the shockwave and ultrasound device.
Moreover, the fact that the device according to the invention can be interfaced with an impedance meter allows to evaluate, if needle electrodes are not used, the total, intracellular and extracellular body water percentage or to determine, if needle electrodes are used, the tissue resistivity of the specific regions to be treated.
Moreover, the fact that the device according to the invention can be interfaced with a thermograph allows to monitor therapeutic improvement and allows to assess the extent and severity of the microcirculatory damage easily, non-invasively and repeatably.
Moreover, the fact that the device comprises means for avoiding loss of calibration allows to identify the optimum frequency of oscillation of the ultrasonic acoustic pressure waves emitted by each handpiece and therefore ensure maximum effectiveness of the treatments.
Finally, the fact that the device comprises a handpiece provided with depilation means that emit Shockwaves and ultrasounds that produce a cavitation process allows the treatment of hirsutism, avoiding side effects, damage to tissues adjacent to the hair follicle and allows greater safety, less pain and the possibility to be used with any type of hair and for any skin tone.
The device for treating cellulite and localized adiposity, according to the invention, thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the appended claims.
Moreover, all the details may be replaced with other technically equivalent elements.
In practice, the materials used, as well as the dimensions, may be any according to requirements and to the state of the art.

Claims

1. A device for treating cellulite and localized adiposity, comprising means for generating, simultaneously or separately, pressure Shockwaves and ultrasonic pressure waves with frequencies which can vary within a given range, said waves being emitted by at least one handpiece iii contact with the region of the body to be treated, characterized in that it comprises means adapted to generate vibrations of said at least one handpiece for mechanical drainage of the tissue of said region of the body in contact with said at least one handpiece.
2. The device according to claim 1, characterized in that said means adapted to produce vibrations of said at least one handpiece comprise the insertion in said at least one handpiece of an element that rotates about an axis that passes outside of its center.
3. The device according to one or more of the preceding claims, characterized in that said means adapted to produce vibrations of said at least one handpiece comprise a programmer, which is inserted in said at least one handpiece.
4. The device according to one or more of the preceding claims, characterized in that said pressure Shockwaves have a pulsed behavior with an amplitude of substantially 500 bar, and in that said ultrasonic pressure waves have a sinusoidal behavior with an amplitude of substantially 0.5 bar.
5. The device according to one or more of the preceding claims, characterized in that the frequencies of said ultrasonic waves vary continuously in said given frequency interval that comprises low-frequency values, substantially around 5 kHz.
6. The device according to one or more of the preceding claims, characterized in that the frequencies of said ultrasonic waves vary continuously in said given frequency range which comprises high-frequency values, substantially around 1 MHz.
7. The device according to one or more of the preceding claims, characterized in that said low-frequency range of said ultrasonic waves alternates rapidly and continuously with said high-frequency range of said ultrasonic waves.
8. The device according to one or more of the preceding claims, characterized in that said means for generating ultrasonic pressure waves comprise an electric voltage source, a unit for the adjustment and control of said electric voltage source which is connected to a man-machine interface means, at least one transducer which transduces the alternating electrical field produced by said electrical voltage source into said ultrasonic acoustic pressure waves.
9. The device according to claim 6, characterized in that said adjustment and control unit of said electric voltage source is constituted by a microcontroller.
10. The device according to one or more of the preceding claims, characterized in that it comprises, in said at least one handpiece, means with light emitting diodes which generate infrared light for stimulating the lymphatic and blood system, for stimulation of cellular activity and for stimulation of the surface layers of the skin.
11. The device according to one or more of the preceding claims, characterized in that it comprises hydraulic cooling means for cooling said at least one handpiece and said region of the body to be treated in contact with said at least one handpiece.
12. The device according to one or more of the preceding claims, characterized in that it comprises, in said at least one handpiece, pressure and roller means for generating an endothermic massage which produces a suction effect on the tissue.
13. The device according to claim 10, characterized in that said pressure means and roller means comprise a low-speed pulsed action mode and a high-speed continuous action mode.
14. The device according to one or more of the preceding claims, characterized in that it can be interfaced with a B-mode ultrasonic imaging unit.
15. The device according to one or more of the preceding claims, characterized in that it can be interfaced with at least one between an impedance meter with needle electrodes and an impedance meter without needle electrodes.
16. The device according to one or more of the preceding claims, characterized in that it can be interfaced with a thermograph.
17. The device according to one or more of the preceding claims, characterized in that it comprises means for avoiding loss of calibration of said at least one handpiece.
18. The device according to claim 17, characterized in that said means for avoiding loss of calibration comprise a digital potentiometer and a microcontroller for continuously verifying the optimum frequency value of said ultrasonic acoustic pressure waves emitted by said at least one handpiece.
19. The device according to one or more of the preceding claims, characterized in that it comprises depilation means which are adapted to emit acoustic waves with a frequency comprised substantially between approximately 10 kHz and 60 kHz, and ultrasounds with a frequency comprised substantially between approximately 3 kHz and 28 kHz.
PCT/IT2009/000576 2009-12-23 2009-12-23 Ultrasound device for treating cellulite and localized adiposity WO2011077466A1 (en)

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