WO2010067392A2

WO2010067392A2 - Aesthetic medicine apparatus

Info

Publication number: WO2010067392A2
Application number: PCT/IT2008/000771
Authority: WO
Inventors: Valerio MATANÒ; Egidio Tranfaglia
Original assignee: Promoitalia Group S.P.A.
Priority date: 2008-12-12
Filing date: 2008-12-12
Publication date: 2010-06-17
Also published as: WO2010067392A3

Abstract

The present invention refers to an aesthetic medicine apparatus for the concomitant application of minimally ablative radiofrequency (RF) and resorbable filling solutions, for the treatment of wrinkles or other skin ageing signs. In fact, the apparatus subject- matter of the present invention is configured for subjecting the patient to a concomitant application of radiofrequency and filler. Thus, it is concomitantly carried out a very fine RF ablation of cutaneous tissue, a destruction of a volume of tissue in a controlled and reproducible manner, and a thermal stimulation capable of creating a fibrotic channel in which the filler is deposited in a stable manner.

Description

VESTHETIC MEDICINE APPARATUS DESCRIPTION

The present invention refers to an aesthetic medicine apparatus allowing the concomitant application of minimally ablative radiofrequency (RF) and resorbable filling solutions, for the treatment of wrinkles and the remodeling of face contours and skin depressions or scars. History of the technology

Devices are currently available on the market by which facial rejuvenation therapies (typically indicated as "anti-aging" therapies) can be carried out, consisting exclusively in the injecting in the skin of hyaluronic acid-based or other component-based filling solutions, or in the emission of a radiofrequency.

Filling solutions, also referred to a^ "fillers", are injected in the superficial derm with a very thin needle in order to fill wrinkles, depressions, scars, pronounced nasogenial furrows, or to increase the volume of lips, chin and cheekbones.

Hyaluronic acid is among the most widespread fillers. Hyaluronic acid is a basic component of the derm, but tends to be gradually resorbed with ageing. Its properties give hydration to skin, thanks to its hydrophily, as well as elasticity and softness. This constant and considerable decrease is among the main causes of skin ageing; therefore, repeated injections of hyaluronic acid, besides causing the desired filling effect, allow reactivating mature skins by stimulating their cell functionality, lending to skin its lost compactness and brightness. Description of the prior art

For these reasons, such a substance has successfully been used in the dermatological-aesthetic field since several years. The preparation is injected by the physician with a needle just below the skin portions to be treated. Hyaluronic acid or other basic components for resorbable fillers may be treated with vitamins and coenzymes in order to optimize skin physiology and carry out the so- called "Bio-Revitalization", i.e. a medical treatment integrating in the derm substances that our organism is no longer able to produce in an adequate form (hyaluronic acid, vitamins, minerals, coenzymes, etc).

Among other resorbable fillers used, beside hyaluronic acid, there may be mentioned those based on polytactic acid, bovine collagen, autologous collagen, polyacrylamide, agarose gel, collagen joined to granules (polymethylmethacrylates), vitamins, amino acids, coenzymes, minerals and nucleic acids.

Beside the above-discussed technique, consisting in the injecting of said filling solutions in the skin, in the field of dermatological treatments and aesthetic medicine apparatuses are used which are equipped with a device capable of emitting thermal energy in the form of radiofrequency (RF). The technique exploiting the physical principle of radiofrequency can be of two typologies: ablative radiofrequency and non- ablative radiofrequency.

In particular, non-ablative radiofrequency causes a rise in derm temperature, with the entailed denaturing of part of the pre-existing elastic fibers and collagen and, as a side effect of repair processes, fibroblast stimulation with production of new collagen. Derm remodeling therefore causes the improvement of superficial and deep wrinkles, the compacting of the skin and the increase of its turgidity, lending a wholly natural "lifting" effect to the skin. The end effect of this process will be that of a taut skin, having a more tonic appearance.

On the contrary, ablative radiofrequency causes the destruction of a limited volume of tissue in a controlled and reproducible manner. Ablative RF, with respect to non- ablative RF, is more invasive but allows a more targeted and focalized treatment. Drawbacks of the prior art

Despite the above-illustrated techniques being widely used today, the use of each of said techniques entails several evident drawbacks. As to the use of fillers, the filling effect is variable and depends on the skin type, the facial mimicry, the rate at which the body consumes its own collagen, and the amount and quality of filler used. The aesthetic result is not permanent, owing to the progressive resorption of the substance, requiring periodic reintervention. Such resorption depends on the process of degradation and acceleration of hyaluronic acid and other basic components of the filling solutions, in turn subordinated to the specific patient's lifestyle: smoking habit, environmental pollution, alimentary habits.

The solutions containing hyaluronic acid with vitamins/amino acids and other revitalizing solutions often consist in aqueous solutions which easily tend to shift, be it for poor preparation of the treated anatomical region or because contact with treated zones is not avoided in the post-treatment hours which follow, or lastly for an excessive contraction of the musculature to which the treated region is subjected.

In some specific zones the filler tends to be subjected to unceasing facial motions, and therefore it does not stay still in the same spot. E.g., it may happen that in the eyebrow zone, where contractions are frequent due to amazement, sadness, rage or worry, muscles tend to push the filler until creating shoots about the wrinkle. Hence, thus the opposite effect is attained.

Lastly, the sole injecting of revitalizing solution has a limited effect, as the mere injecting causes scarce fibroblast activation.

As to apparatuses which act by exploiting the RF principle, they often cause traumatic side effects: edema, reddening, erythema (above all periorbital and of the prolabium), postoperatory dyschromias, resulting scars, sensation of heat mingled with paresthesia of the treated zone. These side effects require therapeutic intervention, topical use of hyd rating and anti-oxidizing creams in the days following the intervention, causing longer healing times which unavoidably condition the patient's life. Frequencies preset in marketed devices are not such as to cause the appropriate thermal damage: usually it is either too weak or too strong. Too low a temperature cannot yield effects, whereas excessive heating could lead to relevant protein denaturation, making the procedure ineffective and/or causing the formation of scars. Hence, for any intervention there is an optimal energy amount, suitable for attaining the desired result. Therefore, the extreme variability of the frequencies that may be used makes a treatment success exceedingly difficult, due to what has been highlighted above.

There are also other crucial factors, such as: frequency, power and duration of the pulses, which in marketed apparatuses are not adequately programmed and make less safe and effective this type of technology. Moreover, the apparatuses currently available on the market are designed for either ablative RF or nonablative RF. There follows that the operator is forced to use different apparatuses according to the invasiveness required for the specific treatment. Lastly, marketed probes do not allow to utilize both bipolar and unipolar points or electrodes. In fact, the operator is forced to change handpiece according to needs. In addition, cable designs do not have a shielding double mesh, therefore being characterized by poor safety. Objects of the invention

Object of the present invention is to overcome the drawbacks mentioned hereto with reference to the known art, by providing an aesthetic medicine device as substantially described in claim 1 , further providing an aesthetic medicine apparatus as substantially described in claim 10, and finally providing an aesthetic medicine apparatus as substantially described in claim 13.

Secondary features of the present invention are instead defined in the respective 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 apparatus subject-matter of the present invention is configured for subjecting the patient to a concomitant application of RF and filler for the treatment of wrinkles or other blemishes or signs of skin sagging. Thus, as it will be highlighted hereinafter by the detailed description of a preferred embodiment, given by way of example and not for limitative purposes, with an innovative aesthetic medicine device it is concomitantly carried out a very fine RF ablation of cutaneous tissue, a destruction of a volume of tissue in a controlled and reproducible manner, a thermal stimulation capable of creating a fibrotic channel in which the filler is deposited in a stable manner. In other words, the RF action prepares a channel in which the filling solution is deposited in a stabler and longer-lasting manner with respect to known techniques frequently used today. Therefore, in a single treatment the wrinkle furrow is filled with hyaluronic acid (or other filling solutions) and the fibrotic channel produced by RF is such as to form a sort of shell, or capsule, which will protect the injected solution. The latter in fact, deposited in said resistant and microfibrotic capsule, tends to be more protected, less attackable by enzymatic degradation systems, less soluble, and therefore it will tend to last longer. Moreover, the capsule reduces contraction of muscles that have induced the wrinkle and offers a certain resistance also to mechanical stresses. In fact, by acting on subcutaneous muscles, said capsule reduces their degree of contractility and power, and therefore also the duration of the tightening effect. All this sensibly reduces the chance of a displacement of the filling solution, with the entailed greater duration of the injected implant.

In order to cause a controlled and effective thermal damage, the apparatus subject- matter of the present invention, beside offering the option of manually setting parameters such as, e.g., frequency, intensity and pulses of the generated RF, is preset with two automatic programs for the combined RF/injectable solution treatment, of which 1 program for filler injection and 1 program for revitalizing solution injection. Moreover, the apparatus is prearranged with about 28 programs preset for RF application only, since it could be used even only with said technology, as it will be illustrated in detail hereinafter.

These preset programs allow also an unskilled operator to find his/her bearings and potentiate the effects of RF and of filling or revitalizing solutions, owing to the above- illustrated reasons. Such a programming was developed taking into account that: 1. Frequency: the higher the frequency, the shallower the depth of action will be;

2. Power: the higher the power, the higher the intensity of RF discharge will be; 3. Pulse: the greater the pulses of the RF discharge, the longer the length of RF discharge will be;

4. Pause: the longer the time interval between two pulses, the longer the available recovery time will be. 5. Cycle: number of times in pulses (Pulse) is summed with pause (Pause).

In the hyaluronic acid-based filler program, the following values are provided:

Pulse: 4 s

Pause: 2 s

Cycle: 3 cycles (to perform a serial-point technique) Frequency: 1050 KHz

Power: 0-40W (to be adjusted according to patient's sensitivity)

In the revitalization program the effect of filling solutions in which the main component of the filler is mixed, e.g., with vitamins and coenzymes, is extremely potentiated, as

RF exerts a microdamaging stimulus, allowing said solutions to act on fibroblasts already activated. With the sole injection of revitalizing solution the effect is milder, as fibroblasts are not yet activated and the mere injection causes scarce activation.

In the revitalization program the following values are provided:

Pulse: 3 s

Pause: 1 s Cycle: 2 cycles (to perform a retrograde linear technique)

Frequency: 1050 KHz

Power: 0-32 W (to be adjusted according to patient's sensitivity)

Injection of fillers and revitalizing solutions in combination with RF affords optimum results both in biostimulation, providing fibroblast activation toward neoformation of matrix components, and normalization in the colloidal state of said matrix, and in biorestructuring, providing an activation of fibrotic fibroblast subpopulation in order to increase derm rigidity with scar collagen deposition.

Another advantage is the decrease of some side effects deriving from the application of a single RF, such as, e.g., edema, reddening, erythema (above all periorbital and of the prolabium), resulting scars, sensation of heat mingled with paresthesia of the treated zone. These effects are remarkably reduced thanks to the association of a subdermal RF to a filler having a hydrating and lenitive effect and based on substances having antioxidant effect, such as E, C vitamins and amino acids essential to skin repair processes and production of new collagen.

As to the 28 programs provided for use of the apparatus subject-matter of the present invention by RF only, parameters are set on the basis of the specific area and layer to be treated.

In these programs, Frequency, Cycle, Pulse and Pause are preset on the basis of the specific indication; the operator merely needs to adjust RF emission power (Power). This programs enable to perform a very fine ablation of tissue and, concomitantly, a thermal stimulation capable of triggering a biological process leading to collagen biosynthesis for:

- treatment of linear-patterned skin lesions such as striae distensae (commonly known as "stretch marks"); - wrinkle treatment (glabellar wrinkles, nasolabial folds, periocular folds, puppet line, forehead, neck and decollete wrinkles, lip contour, vertical lifting);

- wrinkle treatment, as a pre- and post-lifting surgery aid, and treatment of vulgar and nodular acne.

- removal of skin neoformations, such as warts or skin tags Therefore, it will be appreciated that beside wrinkles it will be possible to treat other skin damages as well, such as stretch marks and acne.

By using these data, repeatable, good-quality results were obtained. Unlike what occurs with other techniques used today, a programmed RF emission often produces a constant effect; this is possible since electrical conductivity of tissues is nearly the same from individual to individual. Therefore, standardization simplifies the performing of interventions, in the past adjustable only by skilled operators. Power employed is of a few tens of watts, as the zone involved is small-sized. Low powers allow a use targeted to fibroblast realization and microfibrosis without thermal damages. Such a device works without causing burns to the patient. Moreover, inside the apparatus there are:

• a transformer, converting network power from 230V AC to 16V AC, so that all of the internal electronics works at a low voltage;

• three electronic (plug-in) cards, and specifically: o master card: converts the 16 V AC of the transformer to 12 V AC, so as to guarantee the apparatus functionality and safety even with voltages higher or lower than standard network voltage, generates voltage for display backlighting; o CPU card: manages display, receives commands from keyboard, hosts buzzers for acoustic signaling; o actuator card: generates working frequency, adjusts output power volume, receives commands from CPU card. In said card there are a microcontroller, a power stage, which ends on a transformer with electronics-side primary and secondary, with in series a patient-side capacitor, totally separated therebetween.

By such a three-card architecture, it is possible to rapidly diagnose any anomalies, so as to minimize downtime, and give full assistance, replacing the faulty component.

Moreover, the actuator card microcontroller generates working frequency and adjusts power output; in case of microcontroller failure, there being no generating frequency, there is no frequency at the output. This safeguards from undesired straying off the radiofrequency. Lastly, in case of microcontroller or power stage failure the transformer with the secondary and, in series, the condenser, does not enable the neuromuscular stimulation option.

The power supply transformer was inserted to guarantee electrical safety and resistance to short-circuits. Moreover, a microprocessor was inserted so that the amount of power delivered may not exceed the threshold value of 36 W, both in standard use and under first failure conditions; control occurs with a 20-step arrangement, therefore in case of failure of the same there is no generating frequency, and as a consequence there is no radiofrequency at the output.

Lastly, the software reduces power output to no more Jhan about the 20% of rated power output.

Brief description of the drawings

Still further advantages, as well as the features and 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:

Figures 1 and 2 depict in a perspective view a device according to the present invention;

Figure 3 depicts an assembly according to the present invention, comprising the device of Figures 1 and 2; and Figures 4 and 5 illustrate in a perspective view an apparatus according to the present invention.

Detailed description of the drawings

Referring to Figure 1 , it is depicted in a perspective view an aesthetic medicine device 1 , for the treatment of wrinkles and/or other skin blemishes, according to the present invention. Always referring to Figure 1 , the device 1 comprises a needle 2, made of an electrically conductive material, and means 3 for transmitting an electric signal, connected to the needle 2. The needle 2 is made of electrically conductive material so as to be electrified by an electric signal transmitted by the means 3, and that therefore flows thereinside. In the preferred embodiment, given here by way of example and not for limitative purposes, the transmitting means 3 is of wire type. Preferably, such wire transmitting means 3 make a contact connection by welding on the needle 2, but it will be appreciated that also reversible-type connections could be used.

The device 1 subject-matter of the present invention further comprises a bottle 4, containing filling solution to be injected via the needle 2 in a patient's skin. Furthermore, the needle 2 is integral to means 5 for reversible connection with the bottle 4.

As it is evident in Figure 1 , the bottle used in the preferred embodiment shown here is a standard syringe 4.

Referring to next Figure 2, the needle 2 has a side surface 21 and a terminal end wall 22. The needle 2 has an insulating coating, preferably made of Teflon, substantially arranged on the side surface 21. The insulating coating arranged on the side surface leaves uncovered the terminal end wall 22, so as to concentrate the flow of the electric signal through said wall 22, thereby avoiding signal dispersion via the side surface of the needle. Still referring to Figure 2, the wire means 3 for transmitting the electric signal is connectible to an external apparatus (not shown in Figure) by a first monopolar-type terminal jack 6.

Referring now to next Figure 3, it is depicted an aesthetic medicine assembly 10 comprising the device 1 and circuit-making wire means 11. The circuit-making wire means, of monopolar type, comprises a plate 12 apt to be positioned on a patient's skin. The circuit-making wire means 11 , as being of monopolar type, have a second monopolar jack 13, removably connectible to an external generator of RF electric signal (not shown in Figure). Preferably, such a plate is positioned on the patient substantially in correspondence of a zone in which injection of filling solution takes place by means of the electrified needle 2. Therefore, such circuit-making means 11 is necessary to set up a made electric circuit in which the electric signal may transit, in order not to disperse on the patient's skin surface, thereby causing undesired effects.

Referring now to Figure 4, it is depicted an aesthetic medicine apparatus 100 for the treatment - of wrinkles and/or other skin blemishes according to the present invention.

The apparatus 100 comprises an RF electric signal generator 101 , and an handpiece (not depicted in Figure) electrically connected to said generator in a removable and interchangeable manner. Moreover, the apparatus 100 comprises man - machine interface means 300, in order to set parameters (manually or automatically according to the above-described preset programs) for its use. Such interface means comprises, by way of example and not for limitative purposes, an alphanumeric keyboard and a display.

The handpiece connected to the generator 101 could be, alternatively and depending on the required typology of intervention to be performed, the above-described assembly. Therefore, in order to make said removable connection with the assembly, the generator 101 has a pair of monopolar-type female plugs, in which there will respectively be inserted the first jack of the device and the second jack of the circuit- making means, detailed above.

Alternatively, the assembly could be connected to the apparatus 100 also in correspondence of a bipolar-type female plug, by interposing between the two monopolar male jacks of the assembly and the bipolar female plug of the apparatus 100 an adapter (not depicted), comprising a bipolar male jack, apt to be inserted in the bipolar female plug of the apparatus, connected to two monopolar-type female plugs apt to receive each a respective monopolar jack of the assembly. In particular, the generator 101 produces an RF current signal that crosses the wire transmitting means of the device and flows through the needle.

The current signal, thanks to the insulating coating, gets without dispersion on the patient's skin from the needle end in order to create a very fine ablation of cutaneous tissue, concomitantly to the injection of a filling solution, always by means of the needle of the device. The generator 101 comprises thereinside storage batteries (not shown in Figure) required for its power-supplying. The apparatus 100 further comprises an apparatus 200 for recharging said batteries, removably connected with the generator 101. Thus, it will be appreciated how the generator 101 may easily be transported once the batteries have been charged by the apparatus 200, thereby avoiding having to keep it in a stationary position, necessarily near to a power supply.

In addition, said RF signal generator has one or more bipolar-type female plugs, in order to connect, always in a removable and interchangeable manner, various types of handpieces working with both a bipolar and a monopolar technology. As it is known, with the monopolar technique, adopted e.g. for the assembly, it is set up an electric current regimen between two electrodes that are placed into contact with the patient, so that current crossing the skin be such as to cause the desired effects. In the afore-examined case, the needle of the device and the circuit-making plate perform said electrode function.

With the bipolar technique, it is used a single handpiece having the two electrodes positioned on two distal ends of the handpiece itself. In this case, current flow takes place from one end to the other one, exploiting as electrical bridge the amount of treated tissue, which will be appreciated to be extremely less than the monopolar case. It is understood that the contrivances and the technical knowledge needed in order to manufacture a bipolar- or monopolar-type handpiece, or a female plug or a male jack, of bipolar or monopolar type, are deemed to be within the reach of a person skilled in the art and therefore will not be further detailed hereinafter.

Referring to Figure 5, several kinds of bipolar-type handpieces are depicted, which can be connected to the signal generator in an interchangeable manner. In particular, for the application of sole radiofrequency therapy by the apparatus 100 subject-matter of the present invention, there could be used a bipolar handpiece 110 comprising an electrode having a substantially needle-like shape, an unipolar handpiece 120 (behaving as a radial source of electric signal and for which there is no circuit making), comprising an electrode having a terminal element having a substantially spherical shape, or a handpiece 130 having an electrode having a substantially slot-like shape. The present invention has been hereto 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

I . An aesthetic medicine device (1 ) for the treatment of wrinkles and/or other blemishes of a patient's skin, comprising: • a needle (2) for injection of a filler solution in the skin of said patient, made of electrically conductive material and having a side surface (21 ) and a terminal end wall (22); • means (3) for transmitting an electric signal, connectible to said needle (2) and such as to electrify it when crossed by said signal.

2. The device (1) according to the preceding claim, wherein said means (3) for transmitting an electric signal is of wire type.

3. The device (1 ) according to one of the preceding claims, further comprising a bottle (4) containing said filling solution injectable in the skin of said patient and communicating with said needle (2).

4. The device (1 ) according to the preceding claim, wherein said needle comprises means for reversibly connecting with said bottle (5), said reversibly connecting means being integral to said needle (2).

5. The device (1 ) according to claims 4 or 5, wherein said bottle is a syringe (4).

6. The device (1) according to one of the preceding claims, wherein said needle (2) has an external insulating coating.

7. The device (1) according to the preceding claim, wherein said insulating coating is substantially arranged on said side surface (21).

8. The device (1) according to claim 6 or 7, wherein said external insulating coating is made of Teflon.

9. The device (1) according to claim 2 and to one of the preceding claims, wherein said means (3) for transmitting an electric signal is connectible to an external apparatus (4) for generating said signal by a first monopolar-type terminal jack (6).

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10. An aesthetic medicine assembly (10) for the treatment of wrinkles or other blemishes of a patient's skin, comprising: • a device (1 ) according to one of the claims 1 to 9;

• electric circuit-making wire means (11).

I I . The aesthetic medicine assembly (10) according to the preceding claim, wherein said circuit-making wire means (11) is of monopolar type.

12. The aesthetic medicine assembly (10) according to claim 10 or 11, wherein said electric circuit-making wire means (11) comprises a plate (12) apt to be positioned on the skin of said patient.

13. An aesthetic medicine apparatus (100) for the treatment of wrinkles or other blemishes of a patient's skin, comprising:

• an RF electric signal generator (101);

• at least one handpiece (10, 110, 120, 130) electrically connected to said RF signal generator (101) in a removable and interchangeable manner.

14. The apparatus (100) according to the preceding claim, wherein said RF electric signal generator comprises internal storage batteries for its power-supplying.

15. The apparatus (100) according to the preceding claim, further comprising an apparatus (200) for recharging said batteries, said RF electric signal generator (101) being removably connected with said recharging apparatus (200).

16. The apparatus (100) according to one of the claims 13 to 15, wherein said handpiece (10) is an assembly (10) according to one of the claims 10 to 12.

17. The apparatus (100) according to one of the claims 13 to 15, wherein said handpiece (110) is of bipolar type and comprises an electrode having a substantially needle-like shape.

18. The apparatus (100) according to one of the claims 13 to 15, wherein said handpiece (130) is of unipolar type and comprises an electrode having a substantially slot-like shape.

19. The apparatus (100) according to one of the claims 13 to 15, wherein said handpiece (120) is of unipolar type and comprises an electrode having a terminal element having a substantially spherical shape.

20. The apparatus (100) according to one of the claims 13 to 19, further comprising man - machine interface means.

21. The apparatus (100) according to the preceding claim, wherein said man - machine interface means comprises an alphanumeric keyboard and a display.