WO2004095975A1

WO2004095975A1 - Depilating apparatus and method therefor

Info

Publication number: WO2004095975A1
Application number: PCT/IB2004/050554
Authority: WO
Inventors: Franco Ulargiu
Original assignee: Axomed Di Franco Ulargiu
Priority date: 2003-04-29
Filing date: 2004-04-29
Publication date: 2004-11-11
Also published as: ITRM20030206A1; EP1619976A1; ITRM20030206A0

Abstract

A method and an apparatus (1) for carrying out a permanent depilation. The method provides the inoculating in a skin region (8) to be treated of a combination of currents of frequency, amplitude and duration predefined according to the impedance value of the skin region (8) to be treated and detected by an electric probe (7) apt to detect/inoculate said currents, the latter being connected to the apparatus (1).

Description

DEPILATING APPARATUS AND METHOD THEREFOR

DESCRIPTION The present invention refers to a depilating apparatus and to a method therefor and, more precisely, to a digitally managed depilating apparatus and method therefor.

To date, different methods and related apparatuses for carrying out a depilatory treatment with mainly cosmetic purposes on a patient are widely known.

The most ordinary depilating methods known and used to date may be listed as follows: hot or cool depilatory waxes, chemical depilation, electrolysis, Blend method, diathermocoagulation (surgical diathermy), depilation with tweezer electrodes, laser therapy, and electrical photodepilation.

Concerning both hot and cool depilatory waxes, the same categorically the disadvantage to confer only a temporary action. It is also known that chemical depilatories have the task of hydrolyzing creatine, with substances like sulfides, stannates and others, among which, more recently, keratinases. Their action, besides being partial and temporary, may cause folliculitis, skin irritation, hives.

It is also known that the electrolysis uses a weak direct current delivered inside the follicle by means of a needle-shaped electrode connected to the negative pole; due to a chemical process, hydrogen ions are freed and sodium oxide is generated, causing hair and/or bulb necrosis. This technique is painful, slow and unsuitable for extensive depilation.

It is also known that the Blend method introduces a mixture of high-frequency (HF) galvanic currents at the involved zone on the patient. This method seems more effective, yet no significant improvements for slowness and pain during treatments are attained with respect to electrolysis .

It is also known that the diathermocoagulation generates a thermocoagulating process in the follicle portion were the needle-shaped wire (probe) lies when the HF current is delivered. Moreover, for the most part programmable instruments are provided, thereby being possible to adjust the emission time of the HF current. This method is acknowledged as the most effective one since the high frequency, generating heat in tissues, causes localized damage; it is faster than electrolysis and Blend, albeit with the hair-to-hair limitation that makes it always rather slow and painful. When used by unskilled hands, it may cause pigmented spots or skin damage.

It is also known that in the depilation with tweezer -or plate- electrodes an HF current is used, in the so- called capacitive diathermy. Moreover, a product inhibiting hair growth is used. This method marks the first attempt at a NON-invasive definitive depilation, i.e. without using needles, yet so far the practical results were not overly positive. Sometimes the hair grows stronger and thicker since the diathermy current generates a deep heat without coagulating power, therefore with a mere vascularizing and trophic action for the follicle.

It is also known that the LASER depilation draws inspiration from the premises of effectiveness of the medical surgical lasers, therefore from the selective photothermolysis based on the in-tissue transformation of light energy into thermal energy, attaining the downright explosion of the cells. Also this method may be considered non-invasive (the sole laser light is introduced) however the hopes placed in this technique to overcome the negative effects of slowness and pain, with respect to the above so-called iathermocoagulating' methods (surgical diathermy) , have waned since, in most applications, due to the very nature of the laser light beam (unidirectional, collimated and coherent) it is not possible to reach the Bulge zone, made of non-pigmented cells localized sideways to the hair shaft, below the sebaceous gland, inside the epithelial sheath. In fact, its action is essentially carried out onto the melanin contained in the bulb melanocytes. (Fusade, Dermo Time magazine, Jan-Feb 1999) .

In view of the above, the difficulties encountered to date in attempting to attain a complete and definitive depilation are apparent. Various were the protocols proposed, as well as the lasers used, and therefore the wavelengths, the pulse duration, the pulse type and the application of exogenous chromophores. In no case the aim set was attained, and the experience proved that to date lasers are capable of determining a temporary depilation, i.e. a delay in hair growth ranging from 4 to 6 months ( Cenesthesis, Nov 1999, Edgardo Azzolini) .

From the premises reported in the anatomic- physiological description of hair, and from what has been reported by the abovementioned bibliography, apparently in order to attain a permanent depilation the hair germination cells at the bulb zone should be destroyed, but it is necessary to irreversibly damage the Bulge, seat of follicle reproductive cells.

On the other hand, the electrical photodepilation aims at reaching and progressively damaging the entire follicular structure, Bulge included.

The technique is non-invasive, comprising an electronic instrument generating combined HF currents and a conductive gel.

The action mechanisms, attributed by the producers of apparatuses for this method, ought to be 'electrophotonic' and of 'electroporation' , ensuing by virtue of the specificity of the gel, which, binding to the proteins of the hair, would make the latter highly conductive, thereby allowing the flowing of current inside the follicular structure.

Actually, the method entails highly appreciable novelties, above all with regard to the carrying of the current by means of the same hair, and also since it inhibits the synthesis of the Bulge area in the follicle. This invention, though conceptually very interesting, entails evident applicative faults.

A first drawback of this method, and of the related apparatus, ensues from the fact that the latter is designed with analog circuits. Therefore, the same is subject to a rapid obsolescence, as it is not provided with digital technology (microcontrollers or microprocessors), and it does not use any programmable software. Therefore, it is not possible to ensure the reliability and the accuracy undoubtedly crucial in such apparatuses .

Another important drawback lies in the rather empirical and unclear nature of the action mechanisms surmised in this method. In fact, whilst considering the validity of the electrophoretic concept, already described and validated by previous researches (Lee and coll.), it has absolutely not been demonstrated how the electrophotonic mechanism takes place inside the cell, nor how is it possible to have the certainty of inoculating a certain and quantity of current inside the follicle without taking into account and/or metering the impedance of the receiving subject.

It has to be highlighted what macroscopic differentiations have been detected in different subjects when, e.g., the ^λTENS' currents for pain therapy were introduced. Then as well, it became necessary to build apparatuses capable of measuring the individual readiness to feel a current passage. Therefore, these apparatuses were built so as to be capable of predefining power values and times to be adapted to each individual according to the impedance of the latter. Without such a programming, the TENS' proved completely ineffective.

Also some testing on dog, carried out at Murcia University in Spain, highlighted, after several treatment sessions, the coagulation of a certain very limited number of cells. Also the results of the method, even after several years of treatment at several beauty clinics, do not corroborate the definitiveness of such a method. Hence, object of the present invention is to solve the abovementioned drawbacks by providing a depilating apparatus and method therefor enabling the destruction of the entire follicular structure or of portions thereof, anyhow such as to inactivate the follicular structures originating the growth of the hair (BULB) or the re- growth of a new structure (BULGE) .

Another object of the present invention is to provide a depilating apparatus and method therefor providing the option of accurately and reliably programming and metering current frequencies and times, ensuring both the operator to work in absolute safety and accuracy and the patient to attain completely satisfactory results.

Hence, the present invention provides a method as defined in claim 1. Moreover, the present invention provides an apparatus for the application of said method and as defined in claim 10.

Hereinafter, it will be provided a detailed description of a preferred embodiment of the apparatus and of the method of the present invention, given by way of example and without limitative purposes, making reference to the sole annexed drawing schematically illustrating the apparatus during the application of the method of the present invention. With reference to the figure, the apparatus according to the present invention is illustrated. According to the invention, it is provided an apparatus 1 comprising a frame 2 on which there are arranged a display panel 3 and a data input panel 4. To the frame 2 there are connected a normal mains power supply cable 5 and a cable 6, connected at one end thereof to a probe 7. The probe 7 is of the electric probe kind, being apt to come into contact with a patient's skin region 8 to be treated.

The apparatus 1 thus made has therein a set of digital circuits, capable of executing programs apt to accurately and reliably set times and current frequencies toward the electric probe 7. Onto the display panel 3 all parameters are displayed, like e.g. emitted current, times required according to the body zone to be treated, according to values preset in the software of the apparatus and to values detected during the operation thereof (better illustrated hereinafter) .

The electric probe 7 is connected to the apparatus 1 by the cable 6, which is sealed and protected from any discharges, and the former is apt to receive and transmit detected electric values on the skin to/from the circuit portion internal to the apparatus 1. As it will be made apparent hereinafter, for the correct operation of the electric probe 7 it is provided the applying of a conductive means 9 onto the patient's skin 8. Preferably, this conductive means 9 is a gel having the following chemical composition in combination: water, propylene glycol, isopropyl alcohol, sorbitol, bambusoidea, carbomer, triethanolamine, propylparaben, methylparaben, sodium chloride. Hereinafter, the operation principle of the apparatus 1 of the present invention and of the depilating method thereof will be detailed.

First of all, the effectiveness of the method is linked to the power applied to the skin, and not to the voltage (Vs) delivered by the generator, nor to the current (I). As inferred by the fundamental laws of electrotechnics, the power is equal to the product of the voltage applied to the skin times the current delivered by the generator:

P = Vs * I (1)

The current in turn depends on the voltage produced by the generator and on the impedance resulting from the sum among that of the patient's skin (Zs), that outputted by the generator (Zo) , and that of coupling (Zc) , according to the formula:

I = V / (Zs+Zo+Zc) (2)

It follows that the control and the adjustment of the voltage, it does not ensure a correct delivering and applying of a power onto the patient, apart from in highly specific conditions in which Zs, Zc and Zo are known. These conditions are hardly reproducible, or anyhow variable from patient to patient and according to the various body parts thereof.

The apparatus of the present invention overcomes this heavy handicap by resorting to a highly powerful microcontroller, capable of monitoring in real time and continually both the voltage actually applied to the patient's skin and the current flowing therein during the application, by virtue of the use of the electric probe 7. In fact, the intensity of the HF energy inoculated is obtained from time to time and in real time during the treatment, by virtue of a patient-instrument feedback via the same electric probe 7. The impedance data of each individual metered during the treatment are processed by an algorithm, obtained after lengthy studies and set in the software incorporated in the instrument. According to the two readings, the microcontroller is capable of adjusting the amplitude of the delivered voltage so that the product of voltage (Vs) and current (I) (equation 1) is always equal to the optimum required by the treatment. The technique of automatically adjusting the power implies that the coupling impedance Zc is considered as a fraction of the output impedance of the generator. Hence, equation 2 may be rewritten as follows:

I = V / (Zo'+Zs) (3)

The voltage actually applied to the patient's skin is a fraction of that produced, according to the following equation:

Vs = V * Zs/ (Zo'+Zs) (4)

Apparently, in equation (4) occurs the value Zs, an unknown and anyhow variable quantity.

By virtue of its operation logic, the apparatus of the present invention is capable of directly metering the voltage (Vs) . Equation (2) indicates that the current delivered is also a function of the voltage produced. Therefore, it is possible to set the desired power value, on condition that both the value of the voltage applied to the skin and the current flowing therein may be controlled.

According to the invention, the apparatus 1 is capable of instantaneously detecting also the current (I). Hence, the microcontroller is capable of varying the voltage so that the product between voltage Vs and current I is always equal to the optimal power ensuring the utmost effectiveness of the treatment, as a function also of the basic adjustment that is manually set by the operator via the suitable panel 4 on the apparatus 1 and regardless from the output impedance of the generator and from the entity of the coupling impedance.

Therefore, the automatic adjusting of the power ensures the utmost effectiveness of the treatment, greater ease of use and higher safety for the patient, as the adjuster avoids the application of excessive or anyhow hazardous powers.

The electric probe 7 transmits, with the aid of the gel 9 activating the conductivity of the hair inside the follicular structure, a well-defined quantity of current. Said quantity is predefined by the operator upon having metered the current-receiving capability of the treated individual by means of an individual impedance detector located in the apparatus. Thus, it is certain that the quantity of current emitted may be entirely absorbed by the receiver.

More precisely, the operation logic of the apparatus may be contrived as split into two distinct functional blocks: a control block and a power block. The control block houses a highly powerful and flexible microcontroller superintending the operation of the apparatus. The microcontroller executes a firmware residing on a write-on memory: this enables to update the firmware itself, in case of a further scientific studies suggest modifications to the treatment. The microcontroller interacts with the user by means of a mere keyboard and a high-resolution color LCD display kit.

By virtue of the power of the microcontroller, the user fully controls the operation of the apparatus. In particular, the microcontroller can continually and in real time monitor the power (and therefore the energy) applied to the skin, according to memory-residing standard protocols or to manual settings preset by the user. The continual monitoring of the delivered power enables the microcontroller to automatically adjust it so that its value be always the optimal one envisaged by the application protocol, independently from uncontrollable variables acting on said quantity (skin impedance variations, random variations in the pressure exerted by the apparatus probe onto the skin, patient's grounding). The microcontroller is also capable of setting, with a high accuracy, the form of the wave applied to the skin according to the programming and wholly independently from the voltage power-supplying the circuit or from other factors.

Hence, this method is further optimized with respect to the known art since the user may choose among a theoretically unlimited number of different forms, optionally according to the result sought on the specific body part of the patient.

The high-resolution display provides the user with a high number of data: residual time of application or time elapsed from treatment start, form of the applied wave, basic intensity kept constant by the microcontroller, etc. It is also provided an acoustic signaling whose operation is determined by the microcontroller. Such an acoustic signaling may be used to indicate the running out of the time provided for the treatment, but also to signal a faulty probe-skin coupling, with no need to have the operator continually controlling the display, or for other purposes.

The microcontroller is also capable of automatically calibrating the apparatus itself, as well as to signal any malfunctioning. The control card is also provided with a serial port through which the apparatus may be connected to a personal computer for the remote control, the periodical diagnostics or for the updating of the firmware and of the standard protocols.

The most fundamental component for the method according to the present invention is that related to the stabilizing of the delivered power: the microcontroller is provided with a suitable ancillary circuitry enabling it to read the voltage on the patient's skin and the current flowing therein: from the product between the two metered quantities, the microcontroller obtains the value of the power applied to the skin. Also the control motherboard of the apparatus uses a power oscillator whose oscillation amplitude is modulated by the microcontroller according to the desired form and intensity.

On the other hand, onto the motherboard there are suitable precision sensors capable of providing reliable quantities to the microcontroller. The range of applicable powers is broadened, so as to effectively face situations in which a clumsy use of the probe and/or a very poor grounding of the patient cause an excessive drop of the basic power.

Hereinafter, it will be better illustrated the action mechanism of the follicular biolysis, with the entailed progressive death of the cells of the follicular structure (so as to inactivate the reproduction of a hair structure) of said method according to the present invention.

The process occurs by inoculating into the follicular structure, via the hair, a combination of currents having a 570-850kHz frequency, pulsed in a 70- 140 Hz amplitude. Moreover, the current has sinusoidal or triangular waveforms, preferably having a peak-to-peak amplitude ranging from 0 to 200 V. The delivering is adjusted by an impedance-metering detection system apt to allow, with a dedicated algorithm, the inoculating of the optimal dosage of energy via the hair, the latter being made wave guide by virtue of a conductivity enhanced with respect to the skin itself (application of the specific gel) .

The gel at issue was obtained according to studies effected onto the hair and on the keratin components of the latter, in order to modify the chemico-physical structure of the hair by applying, onto the zone to be treated, substances electrolytically related to the hair structure thereof and making the latter more conductive with respect to the skin. Thus, the weak current applied is totally captured by the hair and carried inside the follicular structure. On the other hand, the abovedescribed dedicated software keeps constant the emission power, increasing or decreasing it according to the individual response, or, more precisely, to the individual absorption capability in the different body zones, even of the same subject, so as to provide the certainty of the optimal passage of current and a standardization of the treatments.

The structure of the instrument is provided with a digital indication for displaying the quantity of energy delivered. Furthermore, via a display it is possible to avail oneself of a software for the management of application protocols already preset or programmable by the operator.

Advantageously, the operation logic of the system of the present invention was made updateable, according to results from scientific works and of innovations on the operation modes.

Moreover, advantageously it is provided also the option to operate in the manual mode rather than in the automatic one at the turning on of the instrument.

Experimental Results

For over two years, testing on patients have been carried out at several beauty clinics in order to test the effectiveness of the follicular biolysis treatment according to the method of the present invention.

Moreover, clinical testing on the method have been carried out on a pool of 50 voluntary patients at the University of Sassari (Italy) , in the Department of Biomedical Sciences Institute.

The results obtained at the beauty clinics are referable to the disappearance of the growth in customers affected by hypertrichosis on various body zones, with the permanence to date, i.e. nearly two years after the treatment, of the epilatory effects on the treated zones.

Alike results were obtained also by the clinical testing, with the periodical biopsy sampling of the follicles of the treated zones; said follicles were analyzed under optical and electronic microscopy and with photographic illustrations.

Assessments on the results obtained by biopsy sampling on the same patients with the same analysis methods are under way, in order to confirm the inactive state of the follicles.

The preliminary data acquired to date and detected by statistical analysis and from the diagrams drafted to date seem to confirm what has already been obtained by previous results and at the abovementioned beauty clinics .

The method of the present invention (follicular biolysis) , according to what has been found in clinical testing and in tests at the beauty clinics exhibited no relevant side effect. Moreover, it causes no pain to the receiving subject, nor scarring or pigmented spots do appear.

The treatment is absolutely safe and easy to use in the respect of the indications and norms of use.

The results collected to date give to the method of the present invention (follicular biolysis) more than 84% positiveness of epilatory effectiveness persisting in the treated subjects as of today, i.e. at +18 months from the treatment.

Claims

1. A method of permanent depilation, characterized in that it comprises the following steps :

- applying onto a skin region (8) to be treated a substance (9) that be electrolytically related to the hair structure thereof in order to make said hair structure more conductive with respect to the skin (8);

- detecting the impedance of said skin region (8) to be treated by an electric probe (7) connected to an apparatus (1) comprising a dedicated software and apt to generate electric power;

- inoculating in said skin region (8) a combination of currents with predefined frequency and amplitude according to the detected impedance value of said region and by said electric power-generating apparatus (1);

- constantly controlling via a feedback circuit said frequency and amplitude of said combination of currents; and holding said current inoculating for a predetermined time crossing said skin region (8).

2. The method of permanent depilation according to claim 1, wherein said step of inoculating provides a combination of currents with a frequency ranging from 570 to 850 kHz.

3. The method of permanent depilation according to claim 1 or 2, wherein said step of inoculating provides a combination of currents with a combination pulsed in a 70-140 Hz amplitude.

4. The method of permanent depilation according to claim 1 or 2 or 3, wherein said step of inoculating provides a combination of currents having sinusoidal waveforms .

5. The method of permanent depilation according to the preceding claim, wherein said sinusoidal waveforms have a peak-to-peak amplitude ranging from 0 to 200 V.

6. The method of permanent depilation according to claim 1 or 2 or 3, wherein said step of inoculating provides a combination of currents having triangular waveforms .

7. The method of permanent depilation according to the preceding claim, wherein said triangular waveforms have a peak-to-peak amplitude ranging from 0 to 200 V.

8. The method of permanent depilation according to any one of the preceding claims, wherein the time relative to said step of holding said current inoculating for a predetermined time is set according to the detected impedance value of said skin region (8) to be treated and to a scale of values predefined according to the electric power to be inoculated in said skin region (8) to be treated.

9. The method of permanent depilation according to any one of the preceding claims, wherein said dedicated software of said apparatus (1) is apt to keep constant the inoculated electric power and/or to increase or decrease it according to the impedance-metered individual response for each skin region (8) to be treated.

10. The method for a permanent depilation according to any one of the preceding claims, wherein said substance (9) is a gel having the following chemical composition: Water, propylene glycol, isopropyl alcohol, sorbitol, bambusoidea, carbomer, triethanolamine, propylparaben, methylparaben, sodium chloride.

11. An apparatus (1) for a permanent depilation and apt to carry out the method according to the preceding claims, characterized in that it comprises: a frame (2) apt to house dedicated hardware, firmware and software for managing and controlling the apparatus (1) ;

- a display panel (3) for displaying input/output data set by the operator;

- a data input panel (4) for inputting data that can be displayed on said display panel (3) ;

- a power supply cable (5) ; a cable (6) for circuitally connecting said hardware and an electric probe (7), said probe (7) being apt to come into contact with a skin region (8) to be treated.

12. The apparatus (1) for a permanent depilation according to the preceding claim, wherein said probe (7) is apt to detect the impedance value of the skin region (8) to be treated.

13. The apparatus (1) for a permanent depilation according to claim 11, wherein said probe (7) is apt to inoculate in said skin region (8) a combination of currents of preset frequency and amplitude.

14. The apparatus (1) for a permanent depilation according to claim 11, comprising a dedicated software for generating electric power to the probe (7) according to the impedance value of said skin region (8) to be treated and detected by said probe (7).

15. The apparatus (1) for a permanent depilation according to claim 13, further characterized in that it can inoculate in said skin region (8) a combination of currents of predefined frequency and amplitude according to the detected impedance value of said skin region (8).

16. The apparatus (1) for a permanent depilation according to claim 13, further characterized in that it constantly controls said frequency and amplitude of said combination of currents via a feedback circuit.

17. The apparatus (1) for a permanent depilation according to claim 13, further characterized in that it controls said inoculating of currents in said skin region (8) according to a predetermined time.

18. The apparatus (1) for a permanent depilation according to claim 13, wherein said combination of currents comprises currents with a frequency ranging from 570 to 850 KHz.

19. The apparatus (1) for a permanent depilation according to claim 13, wherein said combination of currents comprises currents with a combination pulsed in a 70 to 140 Hz amplitude.

20. The apparatus (1) for a permanent depilation according to claim 13, wherein said combination of currents comprises currents having sinusoidal waveforms.

21. The apparatus (1) for a permanent depilation according to the preceding claim, wherein said sinusoidal waveforms have a peak-to-peak amplitude ranging from 0 to 200 V.

22. The apparatus (1) for a permanent depilation according to claim 13, wherein said combination of currents comprises currents having triangular waveforms.

23. The apparatus (1) for a permanent depilation according to the preceding claim, wherein said triangular waveforms have a peak-to-peak amplitude ranging from 0 to 200 V.