WO2008114186A2

WO2008114186A2 - Device for the production of low-frequency ultrasound for cellulite and localised adiposity treatment

Info

Publication number: WO2008114186A2
Application number: PCT/IB2008/050961
Authority: WO
Inventors: Giancarlo Millevolte; Egidio Tranfaglia
Original assignee: Promoitalia Group
Priority date: 2007-03-21
Filing date: 2008-03-14
Publication date: 2008-09-25
Also published as: ITRM20070148A1; WO2008114186A3

Abstract

Device for cellulite and localised adiposities cure by ultrasound hydrolipoclasia, producing ultrasound with a frequency ranging between the values of 35 KHz and 55Khz, using an innovative-type handle in order to create, besides a draining effect, an action targeted at the elimination and subsequent reabsorption of adipocyte cells.

Description

Device for the production of low-frequency ultrasound for cellulite and localised adiposity treatment

DESCRIPTION

The present invention refers to a device to be used for the therapeutic treatment of localised adiposity by ultrasound hydrolipoclasia. Technology history Subcutaneous fat tissue is a tissue comprised of fibers and fat, lying between the derm (cutaneous layer located under the epidermis) and the muscle fascia. It constitutes the deepest layer of the skin, and establishes a weak bond between skin and inner organs covered thereby. It substantially performs the functions of protecting deeper tissues from any trauma, representing reserves of strength and limiting loss of heat, contributing to keep body temperature constant.

Adipose tissue is substantially formed by adipocyte cells. These are cells having the ability to synthesize and store triglycerides therein. Moreover, adipocyte cells (or simply "adipocytes") tend to gather together into lobules, generally forming the so-called "panniculus adiposus".

Etymologically, the term "cellulite" suggests a tissue pathology of inflammatory origin (in Italian medical language, the suffix ite indicates an inflammation).

This word, though not exact, has however entered in common (Italian) language, and is widely accepted to indicate a specific type of problem involving the panniculus adiposus.

Considering that to date cellulite genesis still is a phenomenon not altogether clear, and therefore object of numerous studies, cellulite substantially consists in an inflammation that affects the panniculus adiposus, causing an alteration of the latter. As a consequence of this alteration, it is determined an increase in the adipocyte volume, with the entailed transudation of liquids inside the intercellular spaces.

Cellulite, mainly occurring in women, is an actual condition of tissues that does not merely manifest itself in an unaesthetic way, but can also cause cumbersome pains and anyhow constitute a general discomfort of the body. It, as it is known, causes skin surface to assume the characteristic "orange peel" or "mattress" appearance, exhibiting a series of more or less extended swellings. Zones most affected are the hips, buttocks and thighs. Description of the prior art

From common literature, several (non-invasive) methodologies are known for the cure of cellulite or, more generally, the decrease of adipose tissue. Among those, in the last few years cavitational-effect ultrasound hydrolipoclasia has taken hold. It is a non-invasive method for the pathology treatment that aims to reduce adipocytes in volume by use of ultrasound acoustic pressure waves, or "ultrasound". The prefix "ultra" implies that said ultrasound is emitted with frequencies outside of the audibility range for the human ear. Said ultrasound is produced by electro-acoustic transducers: in particular, in this type of applications, ultrasound is artificially produced by means of the characteristics of a piezoelectric material. By applying an AC field on the faces of such a piezoelectric material, there can be obtained thereon an alternation of compressions and decompressions at very high frequencies, producing a field of ultrasound sound waves. By travelling through tissues these ultrasound waves cede thereto, by the known "attenuation" phenomenon, part of their energy.

As it is known in the current state of the art, inside tissues these waves determine a physical phenomenon of "ultrasound cavitation". It is a phenomenon occurring in a liquid subjected to an acoustic wave field, when dynamic negative pressures cause local pressure to drop below the saturation pressure of gases dissolved therein, or below the vapour pressure of the liquid itself. This situation entails, inside the liquid, development of vapour in the form of fine bubbles that become larger during the length of the decompression phase, whereas in the subsequent compression phase they implode, releasing impact energy into the tissues. This released energy causes damages to the surrounding structures, contributing to adipocyte cell fragmentation. Drawbacks of the prior art

Numerous devices based on the principle of generation of pressure waves with a cavitational effect are currently available on the market. They substantially consist of an apparatus comprising a handle that is placed into contact with the body part to be treated. Said handle comprises a transducer of piezoelectric material that performs the transduction of an electric signal received thereby and emits ultrasound into the biological tissues treated. Said devices however, as witnessed by results directly observed on patients, yield mixed and often disappointing results. In fact, at best, patients attain only a draining of the liquids stagnating into tissues, liquids that therefore subsequently tend to be easily reintegrated. This is mostly due both to the frequency values of the ultrasound waves used, generally very high and of the order of MHz, and to the typology of handle used. Therefore, to date most of the times it is carried out only the absorption of liquids formed inside the panniculus adiposus.

Hence, the solutions provided by the modern art entail provisional improvements, yet fail in the attempt at offering a final solution to the problem. Objects of the invention

Object of the present invention is to solve the above-mentioned drawbacks by providing a system as substantially described in claim 1.

Further features of the system are defined in the corresponding dependent claims thereof. Advantages of the invention

The present invention, by overcoming the mentioned problems of the known art, entails several evident advantages.

In fact, the device subject-matter of the present invention proposes the innovative use of ultrasound waves inside of a precise range of frequencies with values ranging from 35 KHz to 55 KHz, sufficiently low to create a localised action on adipocyte cells and allow a dissolving of the fat, yet such as to cause no damage to the surrounding tissues.

Therefore, the precise range of low-frequency ultrasound employed by the device subject-matter of the present invention allows the production of a quantity of energy predetermined and targeted solely to adipose tissue. In fact, differently from similar devices available on the market, ultrasound waves converge and concentrate on focalised zones, producing the immediate effect of rupture of adipocytes and emission of triglycerides, which are then quickly and naturally metabolised. Hence, the range of frequencies used by the device results in the latter acting on adipose tissue only, thereby entailing a safe and effective fat-reducing and volume-decreasing action. The results observed were immediate and measurable, even after only one treatment session (with a reduction of the treated area periphery of up to 2 cm). Moreover, the specific and innovative typology of handle employed by the device, having a greater thickness than those commonly employed in the art, besides giving specific effectiveness to the ultrasound waves emitted entails for treated patients a specific comfort, perceived during and after the treatment session, as well as satisfaction and wish to continue the treatment.

At the end of a session, taking place in the total absence of anaesthesia, immediate resumption of activities was observed in patients; this being further corroborated by the total absence of side effects.

Brief description of the drawings

Still further advantages, as well as the features and the operation steps of the present invention will be made apparent in the following detailed description of a preferred embodiment thereof, given by way of example and not for limitative purposes. Reference will be made to the figures of the annexed drawings, wherein: figure 1 shows a block diagram of the device according to the present invention; figure 2 shows an elevation view of a preferred embodiment of the device subject-matter of the present invention; figure 2A depicts a detail not shown in figure 2; figure 3 shows a detail of the embodiment of the device subject-matter of the present invention; and figure 4 shows a situation of use of the device subject-matter of the present invention.

Detailed description of the drawings

In particular, referring to figure 1 , it schematizes the operation of a device 1 according to the present invention. Therein, it is present a voltage generator 2 that sends an electric signal to a transducer 5, which performs a transduction of said electric signal into an acoustic pressure signal at frequencies higher than the human audibility range (ultrasound). The adjustment of said voltage generator 2 occurs by means of a programmable control and adjustment microprocessor unit 6 (microcontroller adjustment unit 6), in turn managed by the operator by interface means 7. Said voltage generator and control unit are components well-known in the current state of the art, therefore hereinafter a detailed description thereof will be omitted.

Referring to figure 2, a preferred embodiment of the device 1 subject-matter of the present invention is depicted by way of example and not for limitative purposes.

Said device 1 comprises a body 20, having at its base a carriage 21 in order to be easily transportable.

Inside said body 20 are present said control unit 6 and said voltage generator 2 (not shown in figure). The electric signal produced by the voltage generator is sent, via connecting means 26, to a pair of twin handles 3. As better highlighted in figure 2A, said handles 3 are preferably arranged, when not in operation, on a pair of shelves 22, integral to said body 20. In the preferred embodiment, shown here by way of example and not for limitative purposes, said connecting means 26 is of wire type. The availability of a pair of handles can prove particularly convenient, as it provides the option of concomitantly treating two patients, or of concomitantly treating two different zones of the same patient.

Moreover, on said body 20 it is obtained human - machine interface means 7, comprising, by way of example and not for limitative purposes, a display and a keyboard. By said interface, connected to said control unit 6, an operator has the option of adjusting and programming the operation of the device 1 , e.g., by setting treatment times, power used, frequencies and emission times of the ultrasound produced. Said interface means could also be made by more advanced technologies, e.g. by equipping said device 1 with a "touch - screen" type terminal. In particular, referring to figure 3, said handle 3 has a first grip member 30 connected with a plate 4, made of conducting material and preferably of steel, having cylindrical shape. Said steel plate 4 has an elevated thickness of height equal to about 1.5 cm. Directly on a free circular surface 31 of said steel plate 4 it is attached, in a concentric position, the transducer 5. Said transducer 5, made of piezoelectric material, has it also a cylindrical shape and has a diameter smaller than the diameter of said circular surface 31. The electric signal coming from said generator 2, sent on said steel plate 4 by said connecting means 26, establishes therein an electric field entailing a deformation of the piezoelectric transducer 5 attached thereon. The properties of piezoelectric materials are well known in the literature; therefore the principles underlying their use in the art will be omitted, their practical implementation being within the reach of a person skilled in the art. By suitably adjusting the electric signal sent by the voltage generator, it is possible to obtain from the transducer 5 a production of pressure waves at frequencies higher than the human audibility range (ultrasound), treating the localised adiposities of the patient according to the cavitation mechanism illustrated in the foregoing.

In particular, the device subject-matter of the present invention uses ultrasound with frequency values ranging from 35 kHz to 55 kHz. In fact, it was found that ultrasound emitted with these frequencies entail on adipocyte cells an action targeted at their dissolving, thus overcoming the problems related to similar devices present to date on the market, which as mentioned contribute to carry out only an action of removal of liquids stagnating inside adipose tissues. Preferably, a frequency value close to 40 KHz is set. Preferably, a frequency value close to 50 KHz is set. Finally, said grip member 30 comprises, at an edge thereof, a ring-shaped luminous indicator 9, active under conditions of use of the device. This provides an immediate reference for the operator, indicating the operativeness of the device itself. Finally, referring to figure 4, it is depicted a situation of use of the device 1 subject-matter of the present invention. In particular, it is shown the handle 3 brought into contact with a patient's skin at the piezoelectric transducer 5, attached onto the surface 31 of the steel plate 4. Body parts most often subject of the therapy are abdomen, girdle, hips (a body part also known as "saddle bags"), inner thighs and the back of the knees. The present invention has hereto been described with reference to a preferred embodiment thereof. It is understood that other embodiments might exist, all falling within the concept of the same invention, and all comprised within the protective scope of the claims hereinafter.

Claims

1. A device (1) to be used in ultrasound hydrolipoclasia therapy for cellulite and localised adiposity treatment, comprising:

• A voltage generator (2); • A control and adjustment unit (6) for controlling and adjusting said voltage generator (2);

• at least one handle (3) having a plate (4) of electric conductor material to which it is integral at least one transducer (5) apt to perform the transduction of an electric signal into acoustic pressure waves at ultrasound frequency;

• connecting means (26) between said voltage generator (2) and said at least one handle (3); and

• human-machine interface means (7), connected to said adjustment unit (6), said device (1) being characterised in that said ultrasound frequency has a value ranging from 35 KHz to 55 KHz.

2. The device (1) according to the preceding claim, wherein said plate (4) has a substantially cylindrical shape with a thickness of height equal to about 1.5 cm.

3. The device (1) according to claim 1 or 2, wherein said plate (4) is made of steel.

4. The device (1) according to any one of the preceding claims, wherein said transducer (5) is of piezoelectric type.

5. The device (1) according to any one of the preceding claims, wherein said transducer (5) has a substantially cylindrical shape and is attached directly on said plate (4) at a free circular surface (31) thereof.

6. The device according to the preceding claim, wherein said transducer (5) is attached in a concentric position with respect to said free circular surface (31).

7. The device (1) according to any one of the preceding claims, wherein said at least one handle (3) comprises a grip member (30).

8. The device (1) according to the preceding claim, wherein said grip member (30) comprises at an edge thereof a luminous indicator (9), active under operative conditions.

9. The device (1) according to the preceding claim, wherein said luminous indicator (9) is substantially ring-shaped.

10. The device (1) according to any one of the preceding claims, wherein said interface means comprises a keyboard and a display.

11. The device (1) according to any one of the preceding claims, wherein said interface means comprises a "touch - screen" type terminal.