WO2010135793A1

WO2010135793A1 - Devices and methods for conducting radiofrequency microsclerosis, optionally associated with chemical sclerosis in the treatment of spider veins and small varicose veins

Info

Publication number: WO2010135793A1
Application number: PCT/BR2010/000107
Authority: WO
Inventors: Eduardo Sisterolli Alencar
Original assignee: Individual
Current assignee: Individual
Priority date: 2009-05-29
Filing date: 2010-03-24
Publication date: 2010-12-02
Anticipated expiration: 2011-11-29
Also published as: BRPI0903829A2

Abstract

The present invention relates to devices and methods for medical use, designed to eliminate spider veins and small varicose veins, using radiofrequency coagulation, optionally and simultaneously with the chemical sclerosis, using special needle (15) and syringe (31), disposable and modified, and an electric radiofrequency generator, with some enhancements. The invention provides solutions to connect the non- insulated needle tip (6) to a contact metal pin (19), located at the syringe flange (25).

Description

"DEVICES AND METHODS FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS, OPTIONALLY ASSOCIATED WITH CHEMICAL SCLEROSIS IN THE TREATMENT OF SPIDER VEINS AND SMALL VARICOSE VEINS"

FIELD OF THE INVENTION

The present invention relates to devices and methods for medical use, designed to eliminate spider veins and small varicose veins, using radiofrequency coagulation, optionally and simultaneously with the chemical sclerosis.

BACKGROUND OF THE INVENTION

Spider veins are capillary, arterial or venous dilatations, with a diameter smaller than 2 mm, which sometimes are grouped, forming large networks. Small varicose veins are dilated veins with a diameter from 1 to 3 mm. They may be present anywhere in the body, most commonly in the lower limbs, where they produce increased venous pressure, causing painful and aesthetic problems. Several medical treatments have been proposed, in order to eliminate the spider veins and the small varicose veins:

- Chemical sclerosis, the most used technique today, usually performed without anesthesia, with a thin needle, involving the introduction of a sclerosing agent in the interior of these vessels, to destroy their internal walls, causing fibrosis and their disappearance. Despite the effectiveness of this method, sometimes many sclerosing injections are required in the same group of vessels, with sessions held weekly, to obtain a satisfactory result, that is their elimination.

- Laser sclerosis, which makes use of the properties of a monochromatic light beam in order to "burn" the vessel. This technique has several restrictions, including only being effective in certain types of vessels, often causing spots on the skin and can only be prescribed to fair- skinned patients.

-High-intensity pulsed light, which uses a high-intensity light, which is applied for extremely brief periods, on the vessels to be treated, with the intention to "burn them" and, not infrequently, also produces serious skin burns and is rarely used today.

-Surgery, that consists in the extraction of varicose veins with a thin needle with a hook in its tip, through small incisions and is commonly indicated for venous dilatations of larger size. - Electrosclerosis

Electrosclerosis is a method of removing varicose veins that uses a solid needle, applying high-frequency pulses to the spider veins and small varicose veins, using an electric radiofrequency generator (RF generator), which is nothing more than an electric scalpel, in order to "burn" these worked vessels. These "burned" vessels are replaced by fϊbrotic scar tissue and disappear.

These high-frequency electric generators operate in a frequency range that varies from 300 KHz to 4 MHz, and produce tissue heating, dehydrating it and destroying it. Despite the effectiveness, until now, electrosclerosis has been limited due to not insulating other tissues, also "burning" neighboring tissues, including the skin, causing unbearable pain, which requires local anesthesia. As it also affects the skin, this method creates crusting skin reactions, which can develop into definitive hypochromic spots. The difficulty to perform this therapeutic method in spider veins is the small size of these vessels and, especially, its very superficial location, many times less than 0.5 mm from the skin, making it difficult to select just the spider vein when "burning it", preserving the surrounding skin and tissue integrity.

The models of insulated needles presented, until now, leave a long distal extension without insulation, which results in skin and other joint tissue burns, and causes intense pain. Another alternative method has suggested the use of these needles, puncturing a section of skin, away from the vessel, traversing a long subdermal path, until all the non-insulated part of the needle has penetrated and the vessel has been reached by the tip of the needle; this method was unsatisfactory, because as many punctures are performed during a session of varicose veins sclerosis, usually over 30, the act of making the needle traverse large extensions of tissue makes the procedure very painful, and it is impractical without some kind of anesthesia. Moreover, in the same method, the large distal non-insulated extension of these needles may not "burn" the skin, but it certainly destroys the adjacent subdermal tissues, which is not desirable, and also increases the discomfort of the patient. Furthermore, no device was created to allow the simultaneous procedure of electrosclerosis and chemical sclerosis.

SUMMARY OF THE INVENTION

The proposed invention refers to devices and methods, for medical use, to perform the radiofrequency microsclerosis, which does not cause significant pain in the act of puncturing and "burning" the spider vein or the small varicose vein, making it selectively, preserving the integrity of other tissues and can also be conducted simultaneously with chemical sclerosis, increasing the effectiveness of current sclerotherapy procedures, for the following reasons:

- As a hollow needle shaft is used, the chemical sclerosis, the most frequently used treatment nowadays, can be performed simultaneously with the microsclerosis without changes in its technique, increasing their efficiency and reducing the number of sclerotherapy sessions.

- As the needles proposed have a very small gauge, with a very sharp cutting, pain and discomfort caused by the puncture of the spider vein or the small varicose veins will be perfectly bearable, not differing from the current chemical sclerosis punctures. - Before the electric cauterizing discharge, the injection of sclerosing substances or small quantities of neutral liquid will allow the doctor to make sure that the needle is correctly positioned inside the vessel. This is possible because the sclerosant liquid is usually colorless, and when this substance is injected into the vessel, it disappears momentarily because the blood, with its red color, is replaced by the colorless liquid, ensuring the physician who performs the procedure that the tip of the needle is properly located in the interior of the vessel.

- In the case of face spider veins, in which there are contraindications for chemical sclerosis, or in cases where the medical professional prefers to perform only the radiofrequency microsclerosis, it is possible to use a neutral substance, such as distilled water, mixed with a certain amount of anesthetic, to certify the correct location of the needle tip.

- A small gauge needle, with its small non-insulated area, which is in contact only with the internal wall of the small vessel, will apply a much lower electric power, also decreasing pain and discomfort.

- The invention and methods proposed do not prevent the simultaneous use of other medical techniques in order to enhance the effectiveness and reduce the pain, such as criosclerosis, crioanesthesia with cold air and the addition of small quantities of the anesthetic in the liquid to be injected.

To reach the objectives above, it is necessary to use a syringe and needle, with the same conformation of the ones used today, with some modifications:

- The needle should have just a minimum non insulated area in its tip to burn, selectively, only the interior of the spider vein or small varicose veins.

- The insulation of the needle should be made with material that can be applied in micro layer, preferably less than 100 microns, not to cause marked differences in the surface of the needle, which would increase pain during the skin puncturing.

- There must be an efficient mechanism of electric conduction, from the non-insulated tip of the needle to the syringe flange, which is the ideal place to connect the wire to the positive pole of the electric radiofrequency generator, where the wiring does not affect the handling of the syringe. - As the same needle is used for several punctures, there must be mechanisms to prevent unwanted tissue adherence in the non-insulated area of the needle tip, after application of electric coagulation pulses, which deteriorate the sharpness of the bevel.

- Both syringe and needle should have a similar layout and functionality comparing to the syringe and needle available in the market, to make the injection of sclerosing agent or neutral liquid, allowing the simultaneous implementation of chemical sclerosis and/or to certify the correct location of the needle tip.

- A syringe and needle should be disposable and low-cost.

In the case of very thin vessels, the RF generator must also have specific characteristics such as low power, up to 20 watts, and power adjustment in small intervals, preferably at intervals of 0.1 watt or less.

To avoid tissue adhesion in the non-insulated tip of the needle, which is usual when using an electrocautery, the proposed method suggests some useful techniques, effective in daily practice. First, it is observed that when the tip of an electrocautery is cooled, the adhesion either does not occur or it is significantly decreased. The simultaneous use of criosclerosis, which consists in cooling the syringe containing the liquid to be injected at temperatures from 0 to -40 degrees Celsius, is particularly useful because, in addition to preventing unwanted adhesion, it adds the benefits of criosclerosis to the procedure. These benefits, mentioned in the literature and already proved in medical practice, are increasing the effectiveness of chemical sclerosis, due to the severe cooling of the injected fluid, which helps to cause greater destruction of the inner wall of the vessel, less pain, because the cold has anesthetic properties, and reduction of the micro- hematomas, as the cold also has vasoconstrictor effect.

Another tactic, used to avoid this adhesion, is the application of electrical pulses, before completely finishing the injection of liquid. The final flow of the injected liquid prevents the tissue adherence.

The invention will be described below with reference to its typical concretization and also with reference to the accompanying drawings:

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 illustrates a side view of the metal shaft of the needle proposed, according to the invention.

Figure 2 illustrates, in longitudinal cut, the version number 1 of the needle shaft proposed, according to the invention.

Figure 3 illustrates, in longitudinal cut, the version number 2 of the needle shaft proposed, according to the invention.

Figure 4 illustrates, in longitudinal cut, the version number 3 of the needle shaft proposed, according to the invention. Figure 5 illustrates, in transversal cut, the layers of the insulated part of the metal shaft, common to all versions of needle shafts proposed, according to the invention.

Figure 6 illustrates a side view of the complete needle proposed, according to the invention. Figure 7 illustrates, in longitudinal cut, the layers of the version number 1 of the complete needle proposed, according to the invention.

Figure 8 illustrates, in longitudinal cut, the layers of the version number 2 of the complete needle proposed, according to the invention.

Figure 9 shows a side view of the syringe proposed, according to the invention.

Figure 10 illustrates, in longitudinal cut, the layers of the syringe proposed, according to the invention.

Figure 11 illustrates, in enlarged longitudinal cut, details of the distal segment of the syringe proposed and its connection with the needle proposed, according to the invention. Figure 12 illustrates an overview of all the proposed devices and their connections, according to the invention.

DESCRIPTION OF DISCLOSED EMBODIMENTS

Figure 1 shows a side view of the metal shaft needle and its parts: the bevel (26), which is the chamfered sharpened extremity of the metal shaft (27), and serves to perform the penetration in the tissues, causing as little pain as possible, and the metal shaft (27), hollow internally and insulated externally, in whose lumen (14) runs the medication. In this figure, two cuts were proposed: a longitudinal, which will serve to detail the internal layers of the 3 versions of the shaft needles proposed (figs. 2, 3 and 4), and transversal, which will serve to detail as the insulating material covers the metal shaft (27).

Figure 2, shows, in longitudinal cut, version number 1 of the layers of a metal shaft proposed, which is especially useful in the treatment of thinner spider veins, as it has just a minimum non-insulated distal area. The distance (B) is the external diameter of the bevel (26). The outer layer (1), not represented here in correct proportion (and in figs. 3, 4 and 5), due to its small thickness, is composed of insulating materials that can be applied in micro layers, citing as an example the Teflon ® (polytetrafluoroethylene) which, under proper treatment, adheres well to metal. Not to make the penetration of the bevel (26) and/or the metal shaft (27) in the skin difficult, the insulating micro layer (1) must be less than 100 microns thick, varying in proportion according to the size of the needle. We see that the insulating layer (1) coats also a part of the bevel of the needle (26), covering its upper half (T). The non-insulated part of the metal shaft (6, 6 ') of this version extends, in the upper part (6'), across the surface of the lower half of the bevel (26) (half distance B) and in the lower part (6), extends around the entire circumference of the metal shaft (27), from its extreme tip, to the vertical line (F), which crosses the middle of the bevel in the upper part (26). This insulation can be applied to the existing needles, manufactured by several companies, for use in chemical sclerosis sessions, specifically the needles 30 G ¹A, 27 Vi G and 26 G ¹A, that may vary for larger sizes, according to the size of spider veins and small varicose veins. Those needles have a diameter ranging between 0.3 mm and 0.45 mm. Figure 3 demonstrates version number 2 of a metal shaft proposed, differing from version number 1 (fig. 2) just because the total area of the surface of the bevel (26) is not insulated (6"), and that non-insulated part extends by the distal metal shaft (6), in its entire circumference, from its extreme tip to the vertical line (G), which crosses the upper limit of the bevel (26) (distance C). This version is indicated for the treatment of spider veins of larger sizes, using needles size 30 G ^ιΛ, 27 G Vi, 26 G VT. and 25 G Vi, with a diameter ranging between 0.3 mm and 0.5 mm.

Figure 4 demonstrates version number 3 of a metal shaft proposed, differing from version number 2 (fig. 3) only by having a greater length of the distal non-insulated metal shaft (6, 6" '). The distance (D), ranges from 0.5 to 5 mm and the distance (E), extends to a vertical line (H), which crosses the proximal limit of the distance (D). This version is indicated for the treatment of spider veins of larger sizes and for small varicose veins, which need a larger area of electrical contact, using needles of sizes equal to or greater than 27 G ¹A, with diameters larger than 0.4 mm. Figure 5 shows, with no proportion, due to the micro thickness of the insulating layer, the transversal section of the insulated part of the metal shaft (27), defined in Figure 1. We can observe the layers of the insulated part of the metal shaft (27), the external micro layer, which is composed of the insulating material (1), the metal part of the shaft (28) and its lumen (14).

Figure 6 shows a side view of the complete needle (15). The insulated (1) and non-insulated parts (6) of the metal shaft (27) and the plastic hub (18), that allows the connection to the syringe, can be noted. The hub of the needle (18) may or may not have a thin conductive base metal (9), according to the version proposed. A longitudinal cut is shown, to detail its internal layers, in Figures 7 and 8. This model serves for the assembly of all versions of the shafts needles proposals (figs. 2, 3 and 4).

Figure 7 shows, in longitudinal cut, the layers of version number 1 of the needle hub (18), illustrated in Figure 6. Observe that the metal shaft (27) is connected (11) with a thin electrical conductor (12) which crosses internally through the plastic layer of the needle hub (18), ending in contiguity with the base metal contact of the needle hub (9). Distance (A) refers to the total length of the metal shaft (27) and can vary from 13 mm to 40 mm, depending on their diameter. This model serves for the assembly of all versions of the needle shafts proposed (figs. 2, 3 and 4).

Figure 8 shows, in longitudinal cut, the layers of version number 2 of the needle hub (18), illustrated in Figure 6. Unlike version number 1 (fig. 7), we can see that here the metal shaft (27) is connected (11 ') with a conductive material (9') that partially or completely covers the inside of the plastic hub (18). Distance (A) refers to the total length of the metal tube (27) and can vary from 13 mm to 40 mm, depending on their diameter. This model serves for the assembly of all versions of the needle shafts proposed (figs. 2, 3 and 4).

Figure 9 shows a side view of the syringe. We can see the lock tip (16) (16 '), the plastic barrel (17), the plunger (55) and the finger flange (25). Unlike a common syringe, the tip of one of the flanges (25) has a metal pin connector (19), which serves for external electrical connection, through a flexible electric wire to an electric radiofrequency generator. This syringe is disposable, made of plastic and can have variable sizes, with volume capacity from 1 to 10 ml, preferably from 3 ml to 5 ml. This figure has proposed a longitudinal cut, which will serve to illustrate their internal layers in Figure 10.

Figure 10 shows, in longitudinal cut, the syringe layers, as illustrated in Figure 9. In this cut, we can see the rubber plunger head (24). Thin metal contacts cover partially or completely the base of the lock tip of the syringe (16) and the outer surface of the lock tip of the syringe (16 '). They are connected to an electrical conductor (20), which extends across the side of the plastic barrel (17) and one of the flanges (25), exteriorizing on the tip of one of the flanges (25) as a metallic pin (19) for external connection, using a flexible and thin gauge electric wire, to the electric radio frequency generator. The liquids to be injected are stored inside the plastic barrel of the syringe (23). Figure 11 shows, in enlarged view, to display more details, the connection (54) between the electrical conductive material, which covers the inner part of the needle hub (9 '), and/or the base metal of the needle hub (9) and the electrical conductive material from the outer part of the syringe tip (21 ') and/or the base metal layer of the syringe tip (21). The contacts of the syringe tip (21) (2T) continue with a thin electrical conductor (20), which extends throughout the length of the plastic barrel (17).

Figure 12 illustrates an overview of all the devices and their connections. The electrical radiofrequency generator, simply called RF generator (32), operates in monopolar mode, has a power that ranges from 0 to 20 Watts, and works at a frequency between 300 kHz and 4 MHz, preferably in the range of 2 MHz. The RF generator is composed of an alphanumeric display (33), a positive connection to the syringe (34), a ground connection to the patient (35) and a multiple pin connection to the pedal (36). The controls (37) adjust the power from 0 to 20 Watts, with intervals of increase of 0.1 watt or less, and the usual doctor presets, which can be quickly selected during the treatment, by a simple tap on the pedal control (40). The double pedal controls the power of the pulse (38) and the pulse discharges. The right switch triggers the pulse (39) and the left switch (40) selects presets previously set by the physician, which vary according to the size of the vessel. This pedal is connected to the RF generator (32) by a power cable (41) and a metal pin (42). The patient's wristband or ankle band (52) consists of a velcro strip

(43), internally coated by flexible electric conductive material (45), which should be covered by a good conductivity electrolyte gel, responsible for making contact with the patient's skin. It has a female pin on the side (44) and connects with the output ground (35) of the RF generator (32), using a flexible electric wire, with connectors at its tips. Eventually, the patient's wristband or ankle band (52) can be replaced by a metal plate, which is responsible for making contact with their skin.

The doctor's wristband (53) only serves as a support for the wire, not to weigh on the syringe, facilitating its handling. It consists of a strip of velcro (47) with a double female pin on the side (48), which serves as a connection to the wire (51) that connects to the RF generator positive pole (34) and the wire (49) that is connected to the pin of the syringe flange (19). These connections are very useful, allowing doctors to disconnect and reconnect the wires, providing greater mobility to work in the office.

The methodology for the use of the devices varies according to the location of the spider veins or the small varicose veins. In the lower limbs, it is preferable to use the RF microsclerosis, associated with chemical sclerosis. In this case, after putting on the doctor's and patient's wristbands and connecting the wires appropriately (the patient's wristband or ankleband (52) has the inner surface previously covered with an electrolyte gel), the special RF syringe (31) is filled with the sclerosant agent, preferably a glicose 75%, using a common needle of larger diameter, and mixing up small amount of anesthetic liquid, in the proportion from 1 to 10 by 3 to 10. A special RF needle (15) is connected to the syringe and wire (49) connected to pin of the syringe (19) and the pin of the medical wristband (48). The physician then chooses the appropriate preset, according to the diameter of the vessel to be treated, with the left pedal (40) and then, after puncturing the vessel, injects a small amount of the sclerosant agent. While finishing the injection of sclerosant, or after having finished it, the physician applies an electric pulse of RF, with the right pedal (39), to "burn" and conclude sclerosis of the vessel punctured. The prior injection of sclerosant is used to achieve two purposes. The first is to be sure of the correct location of the needle tip inside the vessel; in this case, we observe its temporary disappearance, because the blood contained therein is replaced by the colorless sclerosing material. The second, not less important, is to add the effect of the chemical sclerosis, which affects spider veins branches in distant locations from the punctured vessel. As mentioned before, several sessions are needed for chemical sclerosis to definitively eliminate a group of spider veins and small varicose veins; the simultaneous execution of these two methods reduces the number of sessions significantly and, consequently, the suffering of the patient. Post-puncture bleeding, which is always present after removing the needle from the skin, and makes the therapeutic procedure when chemical sclerosis alone is performed difficult, does not occur after applying the radiofrequency coagulation electric pulse.

Pain can be greatly reduced if the physician uses crioanesthesia with cold air during the procedure. The crioanesthesia consists in applying, in advance and during the procedure, on the location of the spider veins and small varicose veins, cold air, with temperatures of up to 25 ° Celsius negative, partially or completely anesthetizing the skin surface before the puncture. The apparatus for this purpose is already available in the market. In places where chemical sclerosis is contra-indicated, for example, in the face, isolated RF microsclerosis should be used, replacing the sclerosant agent by a neutral liquid such as distilled water for medical use, preferably mixed with an anesthetic, in proportions from 3 to 10. The liquid injected, prior to generation of an RF pulse, serves two purposes: to make sure the correct location of the tip of the shaft needle and to anesthetize the vessel before cauterization.

Claims

1. NEEDLE FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS AND CHEMICAL SCLEROSIS, comprising a metal shaft (27) and a plastic hub (18), characterized by the fact that the metal shaft (27) is partially insulated externally, with a micro layer material (1).

2. NEEDLE FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS AND CHEMICAL SCLEROSIS, according to claim 1, characterized by the fact that the metal SHAFT (27) is hollow, with lumen (14), and has a sharp notch in the tip, the bevel (26).

3. NEEDLE FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS AND CHEMICAL SCLEROSIS, according to claim 1, characterized by the fact that the external insulation of the metal shaft (1) is done with insulating material, applied in micro layer of less than 100 microns.

4. NEEDLE FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS AND CHEMICAL SCLEROSIS, according to claim 3, characterized by the fact that the entire lower half of the bevel (6 '), and the entire circumference of the outer metal shaft (27), at a distance which extends from the distal end of metal shaft to a vertical line (F) that crosses the middle of the bevel (26), is not covered with insulating material.

5. NEEDLE FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS AND CHEMICAL SCLEROSIS, according to claim 3, characterized by the fact that the entire surface of the bevel (6"), and the entire circumference of the outer metal shaft (27), at a distance which extends from the distal end of the metal shaft to the vertical line (G) that crosses the upper limit of the bevel, is not covered with insulating material.

6. NEEDLE FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS AND CHEMICAL SCLEROSIS, according to claim 3, characterized by the fact that the entire surface of the bevel (6"), and the entire circumference of the outer metal shaft (27), at a variable distance, measured from the distal end of the metal shaft, from 0.5 mm to 5 mm, is not covered with insulating material.

7. NEEDLE FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS AND CHEMICAL SCLEROSIS, according to claim 1, characterized by the fact that the plastic hub (18), gives passage to an electric conductive material (12), which connects the proximal part of the metal shaft (11) to an electrical material that covers the base of the plastic hub (9).

8. NEEDLE FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS AND CHEMICAL SCLEROSIS, according to claim

1, characterized by the fact that the plastic hub (18) is covered internally with electric conductive material (9 '), which is connected to the proximal part of the metal shaft (11 ').

9. SYRINGE FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS AND CHEMICAL SCLEROSIS, made of plastic material, composed of a barrel (17), finger flanges (25), a plunger (55), a rubber plunger head (24) and a lock tip for coupling the needle (16), characterized by providing electrical connection between the tip of the needle (6) and a metal pin connector (19), located at the tip of one of the finger flanges (25).

10. SYRINGE FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS AND CHEMICAL SCLEROSIS, according to claim

9, characterized by the fact that the base of the syringe lock tip is covered with electrical conductive material (21) which connects to another electrical conductive material (20) that follows the barrel (17) until a metal pin connector (19) located at the tip of one of the finger flanges (25).

11. SYRINGE FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS AND CHEMICAL SCLEROSIS, according to claim

10, characterized by the fact that the electrical conductive material that covers the base of the syringe lock tip (21) also extends to the outer surface of the internal syringe lock tip (21').

12. RADIOFREQUENCY ELECTRIC GENERATOR AND ACCESSORIES FOR THE IMPLEMENTATION OF MICROSCLEROSIS, composed of an electric radiofrequency generator unit (32), a doctor's wristband (53), a patient's wristband or ankle band (52), electric cables with connectors at their ends and pedal switch (38), characterized by the fact that the electric radiofrequency generator (32) can be calibrated to produce intermittent pulses of coagulation, can be used in the monopolar mode and has variable power control from 0 to 20 Watts.

13. RADIOFREQUENCY ELECTRIC GENERATOR AND ACCESSORIES FOR THE IMPLEMENTATION OF

MICROSCLEROSIS, according to claim 12, characterized by the fact that the controls (37) allow the adjustment of power in intervals equal to or less than 0.1 Watt.

14. RADIOFREQUENCY ELECTRIC GENERATOR AND ACCESSORIES FOR THE IMPLEMENTATION OF

MICROSCLEROSIS, according to claim 12, characterized by the fact that the doctor's wristband (53) has a double pin female electrical connector (48), located externally, on its side.

15. RADIOFREQUENCY ELECTRIC GENERATOR AND ACCESSORIES FOR THE IMPLEMENTATION OF MICROSCLEROSIS, according to claim 12, characterized by the fact that the patient's wristband or ankle band (52) is internally coated with a flexible electric conductive material (45) and there is a connection between it and a female pin connector (44), located externally, on its side.

16. RADIOFREQUENCY ELECTRIC GENERATOR AND ACCESSORIES FOR THE IMPLEMENTATION OF

MICROSCLEROSIS, according to claim 15, characterized by the fact that the patient's wristband or ankle band (52) are replaced by a metal plate.

17. METHOD FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS, ASSOCIATED WITH CHEMICAL SCLEROSIS, IN THE TREATMENT OF SPIDER VEINS AND SMALL VARICOSE VEINS, characterized by the following facts:

- a radiofrequency microsclerosis needle is used, according to claims 1 to 8;

- a radiofrequency microsclerosis syringe is used, according to claims 9 to 11;

- a radiofrequency electric generator and accessories are used, according to claims 12 to 16.

18. METHOD FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS, ASSOCIATED WITH CHEMICAL SCLEROSIS, IN THE TREATMENT OF SPIDER VEINS AND SMALL VARICOSE VEINS, according to claim 17, characterized by the fact that it follows the steps below:

- electrolyte gel is applied inside the patient's wristband or ankle band (52) and adapted to the patient, connecting wire (46) between the patient wristband or ankle band (52) and the radiofrequency generator ground pin (35);

- the interior of the syringe barrel (23) is filled with sclerosant liquid;

- the microsclerosis needle (15) is properly connected in the syringe lock tip (16); - the wristband (53) is put on the doctor, connecting the wires

(49) (51) to the syringe pin (19) and to the positive pole of the radiofrequency generator (34);

- the vessel to be treated is chosen, selecting a proper preset configuration, with the left switch pedal (40); - a small amount of sclerosant liquid is injected, observing the disappearance of the vessel;

- the appropriate amount of sclerosant liquid is injected;

- radiofrequency pulses are applied, triggering the right switch pedal (39).

19. METHOD FOR CONDUCTING RADIOFREQUENCY

MICROSCLEROSIS, ASSOCIATED WITH CHEMICAL SCLEROSIS, IN THE TREATMENT OF SPIDER VEINS AND SMALL VARICOSE VEINS, according to claim 18, characterized by the fact that, if the momentary disappearance of the punctured vessel is not observed when injecting a small amount of sclerosant liquid, the process is interrupted and a new puncture is made.

20. METHOD FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS, ASSOCIATED WITH CHEMICAL SCLEROSIS, IN THE TREATMENT OF SPIDER VEINS AND SMALL VARICOSE VEINS, according to claim 18, characterized by the fact that the syringe (31), containing the sclerosant liquid, is cooled prior to use.

21. METHOD FOR CONDUCTING ISOLATED RADIOFREQUENCY MICROSCLEROSIS, IN THE TREATMENT OF SPIDER VEINS AND SMALL VARICOSE VEINS, characterized by the fact that: - a radiofrequency microsclerosis needle is used, according to claims 1 to 8;

- a radiofrequency microsclerosis syringe is used, according to claims 9 to 11;

22. METHOD FOR CONDUCTING ISOLATED RADIOFREQUENCY MICROSCLEROSIS, IN THE TREATMENT OF SPIDER VEINS AND SMALL VARICOSE VEINS₅ according to claim 21, characterized by the fact that it follows the steps below: - electrolyte gel is applied inside the patient's wristband or ankle band (52) and adapted to the patient, connecting wire (46) between the patient's wristband or ankle band (52) and the radiofrequency generator ground pin (35);

- the interior of the syringe barrel (23) is filled with neutral liquid;

- the microsclerosis needle (15) is properly connected to the syringe lock tip (16);

- the wristband (53) is put on the doctor, connecting the wires (49) (51) to the syringe pin (19) and to the positive pole of the radiofrequency generator (34); - the vessel to be treated is chosen, selecting a proper preset configuration, with the left switch pedal (40);

- a small amount of neutral liquid is injected, observing the disappearance of the vessel;

- the appropriate amount of neutral liquid is injected; - radiofrequency pulses are applied, triggering the right switch pedal (39).

23. METHOD FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS, ASSOCIATED WITH CHEMICAL SCLEROSIS, IN THE TREATMENT OF SPIDER VEINS AND SMALL VARICOSE VEINS, according to claim 22, characterized by the fact that, if the momentary disappearance of the punctured vessel is not observed when injecting a small amount of neutral liquid, the process is interrupted and a new puncture is made.

24. METHOD FOR CONDUCTING RADIOFREQUENCY MICROSCLEROSIS, ASSOCIATED WITH CHEMICAL SCLEROSIS,

IN THE TREATMENT OF SPIDER VEINS AND SMALL VARICOSE VEINS, according to claim 22, characterized by the fact that the syringe (31) containing the neutral liquid is cooled prior to use.