INTRAVENOUS ABLATION DEVICE USING HEAT FROM ELECTRICAL CONDUCTION AND METHOD FOR TEMPERATURE CONTROL OF SAID DEVICE

Description

1 / 15 “INTRAVENOUS ABLATION DEVICE USING HEAT FROM ELECTRICAL CONDUCTION AND METHOD FOR CONTROLLING THE TEMPERATURE OF SAID DEVICE” FIELD OF THE INVENTION

[001] . The present invention belongs to the technological sector of surgical devices and refers to a device for performing endovenous ablation that uses a conductive material connected to an electrical source to generate the heat necessary for tissue ablation.

[002] . Furthermore, the present invention relates to a method of controlling the temperature of said device in situations where it is operating.

[003] . Furthermore, the present invention relates to a thermochemical treatment method by injecting a sclerosing solution (in conjunction with thermal ablation, using the same device). BACKGROUND OF THE INVENTION

[004] . In the field of medicine, the treatment of varicose veins through thermal ablation seeks to disable the diseased vein by means of internally generated heat, promoting the destruction, collapse and fibrosis of the venous wall, which leads to its definitive occlusion. This closure prevents retrograde blood flow, which is the main cause of overload in superficial veins and the appearance of varicose veins, improving symptoms such as pain, heaviness, edema and tiredness in the legs.

[005] . The most popular venous ablation methods involve the occlusion of diseased venous tissues, using Petition 870250070126, dated 06 / 08 / 2025, page 7 / 26 2 / 15 Radiofrequency ablation (RFA) or laser (EVLA - Endovenous Laser Ablation). These procedures are widely used in the treatment of veins in patients, especially varicose veins in the lower limbs. These techniques use a minimally invasive approach, resulting in shorter recovery time, less postoperative pain, and lower complication rates compared to traditional surgeries such as saphenectomy. In this sense, some existing solutions are known:

[006] . Document US2025000570 discloses a radiofrequency cannula for thermal ablation configured to have an embedded electrode guide arrangement, without any foreign material, chemical or element involved, to guide an active electrode tip of a radiofrequency electrode inserted into an internal electrode passage of the radiofrequency cannula to rotate and extend through an electrode outlet opening formed on one side of the radiofrequency cannula, wherein the radiofrequency electrode guide arrangement is embodied to comprise an electrode guide lobe formed by bending a portion of a side wall of an active tip portion in the internal electrode passage to form an inclined stopper to not only guide the active electrode tip of the radiofrequency electrode to extend through the electrode outlet opening,but also to prevent any body tissue from entering the active tip portion, blocking the electrode exit opening of the radiofrequency cannula.

[007] . Furthermore, document US2018250059 discloses ablation systems, methods and controllers comprising a power supply configured to be coupled to a plurality of Petition 870250070126, dated 06 / 08 / 2025, page 8 / 26 3 / 15 electrodes and a controller coupled to the power supply, wherein the controller is configured to determine a thermal gain of each electrode in the plurality of electrodes and, for each electrode in the plurality of electrodes, the controller establishes a power limit based, at least in part, on the determined thermal gain of said electrode. The power limit establishes a maximum power that can be dissipated through said electrode.

[008] . Furthermore, document US2018360535 discloses an electrical ablation apparatus comprising a first and a second electrode, each comprising a first end configured to couple a power source and a second end configured to couple to a tissue treatment region, wherein a power source is coupled to the first and second electrodes and the power source is configured to deliver a first series of electrical pulses sufficient to induce cell necrosis by irreversible electroporation and a second series of electrical pulses sufficient to induce cell necrosis by thermal heating, through at least one of the first and second electrodes.

[009] . However, despite the clinical advantages and technological appeal, both RFA and EVLA have important limitations and challenges that impact their widespread adoption and applicability in different health contexts.

[0010] . From a technical point of view, these methods require a significant learning curve for professionals, who must undergo training to use these devices. In addition, anatomical factors such as vein tortuosity, the presence of anatomical variations, or partial thrombosis Petition 870250070126, dated 06 / 08 / 2025, page 9 / 26 4 / 15 may hinder the introduction and proper positioning of the fibers or catheters used in these devices, limiting the effectiveness of the treatment.

[0011] . Additionally, in these types of devices, the high cost of the necessary equipment, and the need for specific equipment such as radiofrequency or laser generators, disposable optical fibers, etc., represents a considerable obstacle, especially in public health systems and clinics with lower purchasing power. These procedures also require an environment with specific infrastructure, such as operating rooms equipped with imaging and monitoring equipment, as well as the presence of a trained team; thus making the overall cost of treatment significantly high.

[0012] . Given this scenario, the need for a careful evaluation of the cost-benefit ratio of these therapies, the standardization of techniques to reduce variability in results, and the search for solutions that reduce operational costs without compromising the safety and effectiveness of the treatment becomes evident.

[0013] . To solve these problems, the present invention conceives an endovenous ablation device that uses an electrical conductor (Electrode Catheter) to generate heat through the resistive effect of the passage of current through the wall of the treated vessel so that, instead of relying on more complex and costly technologies, such as radiofrequency generators or laser systems with optical fibers, this type of device is based on the conversion of electrical energy into heat by the passage of electric current through a material with controlled resistivity of Petition 870250070126, dated 06 / 08 / 2025, page 10 / 26 5 / 15 an existing electronic generator (electric scalpels),

[0014] . In addition to cost savings, this type of technology can provide greater operational simplicity; reducing the complexity of the procedure, making it safer and less dependent on extensive technical training.

[0015] . Furthermore, the use of controlled resistive heat allows for a direct and localized application of thermal energy, with the potential to achieve effective therapeutic temperatures uniformly along the venous wall, without heat radiation dispersing and causing alterations in adjacent structures. In addition, it is possible to precisely modulate the heating intensity, reducing the risk of thermal damage to adjacent tissues, such as nerves or skin, and improving the safety of the procedure.

[0016] . Finally, with the use of the hemostatic valve and delivery catheter that are part of the product in question, it is possible to inject sclerosing solutions through the lateral connection of the hemostatic valve. This configuration allows the combination of two ablation techniques in a single device, giving rise to the intravenous Thermochemical Ablation (TCA) procedure.

[0017] . Therefore, there is no equivalent solution in the state of the art to that presented here in the present invention that combines technical differences, economic advantages and reliability, safety. OBJECTIVES OF THE INVENTION

[0018] . Therefore, it is an objective of the present invention to provide a solution to the challenges and limitations listed above, by presenting a venous tissue ablation device that uses electrical energy to heat the tissue of interest. Petition 870250070126, dated 06 / 08 / 2025, page 11 / 26 6 / 15

[0019] . It is also an objective of the present invention to promote the safe and effective closure of insufficient veins, of the great and small saphenous veins, by thermal ablation by electrocoagulation, and of incompetent tributary varicose veins, by application of sclerosing agents, including Polidocanol foam, by means of inducing collapse and fibrosis of the incompetent venous wall.

[0020] . It is also an objective of the present invention to provide a device that performs controlled thermal ablation, using heat generated by the resistive effect of the electrical conductor, without the need for radiofrequency or laser, allowing precise control of the temperature and thermal exposure time, adapting the procedure to the characteristics of the vein to be treated.

[0021] . It is also an objective of the present invention to provide a solution that minimizes thermal damage to adjacent tissues, ensuring the safety of the procedure.

[0022] . Furthermore, the present invention aims to provide a device that can be powered by existing electric generators (such as electric scalpels) that are already widely used in other surgical modalities, ensuring full compatibility and easy integration with equipment currently available in the surgical environment.

[0023] . Furthermore, it is an objective of the present invention to provide a safe and efficient device.

[0024] . It is also an objective of the present invention to provide a method of controlling the device. SUMMARY OF THE INVENTION

[0025] . The present invention achieves these and other objectives by Petition 870250070126, dated 06 / 08 / 2025, page 12 / 26 7 / 15 means of a varicose vein ablation device comprising:

[0026] . - a conductive rod connected to an electrical connector by means of rigid welding;

[0027] . - actuator basket with flexible rings fixed to said conductive rod by welding;

[0028] . The said connector is configured to be connected to a surgical electronic generator console and the conductive rod is configured to conduct the power supply current from the console, so that the actuator basket, in contact with the vein wall, is heated by the electric current. The actuator basket is retractable via the rings, so that these contract to allow its introduction through the delivery catheter and, once exposed outside the delivery catheter, the basket expands allowing its contact with the venous wall.

[0029] . In another aspect, the present invention achieves these and other objectives by means of a method for controlling the temperature of a varicose vein ablation device comprising the following steps:

[0030] . - to provide an ablation device comprising:

[0031] . - a conductive rod connected to an electrical connector by means of rigid welding;

[0032] . - the conductive rod comprising an actuating basket with malleable rings fixed to said conductive rod by welding;

[0033] . The said connector is configured to be connected to a surgical electronic generator console and the conductive rod is configured to conduct the power supply current from the console, so that the actuator basket is heated by the electric current upon entering. Petition 870250070126, dated 06 / 08 / 2025, page 13 / 26 8 / 15 in contact with the vein wall. The actuator basket is retractable via the rings, so that these contract to allow its introduction through the delivery catheter and introducer.

[0034] . - connect said device to an electrosurgical unit generator console via the connector;

[0035] . - Set the generator to coagulation mode at a power of 20W to 100W. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] . The present invention will be described based on the attached drawings, which illustrate:

[0037] . - Figure 1 represents the front view of the ablation device of the present invention according to a preferred embodiment.

[0038] . - Figure 2 represents a schematic view of the basket structure of the ablation device according to a preferred embodiment.

[0039] . - Figure 3 represents a detailed view of the basket structure of the ablation device according to a preferred embodiment.

[0040] . - Figure 4 represents the front view of the 'Y' valve that can be used with the ablation device of the present invention according to a preferred embodiment.

[0041] . - Figure 5 represents the front view of the catheter to be used with the ablation device of the present invention according to a preferred embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0042] . The present invention relates to an ablation device. Petition 870250070126, dated 06 / 08 / 2025, page 14 / 26 9 / 15 and varicose vein occlusion powered by an electrosurgical console or generator.

[0043] . The device of the present invention utilizes an innovative construction through a conductive element that promotes the passage of electric current through the tissue (wall of the varicose vein) and causes thermal injury due to the effect of the tissue's biological resistance to the passage of electric current (Joule effect) - the electrical resistance of the tissue generates heat, promoting protein coagulation and closure of the incompetent venous blood vessel (varicose veins). The present invention also includes means of connection with conventional electric current generators (electrosuction device) that are already used for other operating devices and instruments.

[0044] . It is noteworthy that, as already demonstrated, the state of the art does not offer a solution equivalent to the invention described herein. This is because existing solutions utilize laser or radiofrequency ablation, which are complex solutions requiring dedicated equipment for their operation, and do not allow for the concomitant injection of sclerosing solution through the same catheter, increasing the cost of production and operation of the device, as well as the level of technical knowledge required for its use.

[0045] . In this sense, the present invention presents numerous technical and economic advantages when compared with the state of the art, some of which are listed below: • The present invention constitutes a safe and simple-to-construct device, without compromising the ablation results necessary for an excellent operation. Petition 870250070126, dated 06 / 08 / 2025, page 15 / 26 10 / 15 • The present invention comprises high compatibility with instruments already used in surgeries, such as catheters, introducers and electronic scalpel generators, and allows, through a "Y" valve, the injection of sclerosing agent through the same device. • The present invention features easy operation, since it consists of handling the generator that technicians and nurses are already familiar with, in addition to low production and implementation costs;

[0046] . With reference to Fig. 1, the ablation device 01 of the present invention comprises a conductive rod 02 connected to an electrical connector 03.

[0047] . According to a preferred embodiment of the present invention, the conductive rod 02 is a conductive element made of 304V stainless steel with a diameter between 0.3 mm and 0.7 mm.

[0048] . Furthermore, it is foreseen that the conductive rod 02 will be rigidly welded to said electrical connector 03.

[0049] . Electrical connector 03 is an adaptable connector compatible with most models of electrosurgical pens available on the market, whether standard terminals or specific connectors for existing electrosurgical models. Because the conductive rod 02 is directly soldered to electrical connector 03, the choice of connector has little impact on the overall operation of the ablation device 01, since the current from the console, whether a bipolar or monopolar output, will be conducted by the conductive rod 02 and the heating necessary for tissue ablation will occur. Therefore, the production of the ablation device 01 is flexible and Petition 870250070126, dated 06 / 08 / 2025, page 16 / 26 11 / 15 ensures that said ablation device 01 is suitable for the equipment to which it is to be connected.

[0050] . Additionally, located at the distal end of the conducting rod 02, there is an actuating basket 04 welded to the conducting rod 02 by welding. The actuating basket 04 comprises a set of malleable rings 05 with atraumatic profiles minimizing the risk of inadvertent injury to biological tissues.

[0051] . Furthermore, the ablation device 01 also comprises a Y-shaped valve 06 that allows the infusion of sclerosing agents while the device is introduced into the patient, through the same channel, as well as a catheter (C), as illustrated in Figs. 4 and 5.

[0052] . According to Figures 2 and 3, the actuator basket 04 is retractable through the malleability of the rings 05, so that these contract in order to allow its introduction and handling through the delivery catheter (C), maximizing the delivery of thermal energy to the desired region, and enabling its insertion and handling within the venous pathways of a patient. How the device works

[0053] . The ablation device 01 operates by passing an electric current from the generator console (G) into which the electrical connector 03 is inserted. The electrical energy is conducted by the conductive rod 02 and actuating tip 04, causing thermal ablation of the desired regions.

[0054] . Electrical thermal ablation (electrocoagulation) of a venous tissue of interest, such as the great saphenous vein (GSV), is performed via ultrasound-guided puncture of the GSV, followed by Petition 870250070126, dated 06 / 08 / 2025, page 17 / 26 12 / 15 retrograde positioning of a sheath, such as a (B) 6F sheath, and a (C) 6F delivery catheter directed to the junction where insertion will be performed.

[0055] . The head of the ablation device 01 is positioned by retracting the catheter (C), ensuring that only the rims 05 are in contact with the venous wall.

[0056] . The average temperature on the outer surface of the saphenous vein subjected to electrocoagulation can vary from 32 °C to 82 °C. Within this temperature range, no complications related to the procedure were observed. Therefore, this temperature can be controlled by the power source to which the ablation device 01 is connected, preferably using a power of 20W to 100W in the coagulation function.

[0057] . The distal end of the electrocoagulator can be connected to a power source of various models, initiating venous tissue ablation preferably with 60 W for 10 seconds, adjusting as needed based on the electrocoagulator effect images obtained from intraoperative Doppler ultrasound. The catheter (C) and the ablation device 01 can be retracted together every 2 cm during the procedure until the entire incompetent segment of venous tissue is treated.

[0058] . Tests were conducted comparing the electroablation (EA) procedure with radiofrequency ablation (RFA) performed with an intraluminal ClosureFast catheter containing a 7 cm heating element, in which, after positioning the tip 2 cm from the saphenofemoral junction, segmental thermoablation was conducted at 120 °C in 20-second cycles — two cycles for the proximal vein and for segments with a diameter >8 mm, and one cycle Petition 870250070126, dated 06 / 08 / 2025, p. 18 / 26 13 / 15 for the other segments, indicate a similar result, despite the low complexity and cost of the ablation device 01.

[0059] . The results compare the occlusion rate between the RFA (Radiofrequency) and EA (Electroablation using the invention in question) techniques.

[0060] . EA (n=42) RFA(n=43) P-value (MannWhitney test) After 1 week GSV occlusion 42 (100) 39 (90.7) .0430 Complication 3 (7.1) 4 (9.3) .717 After 3 months GSV occlusion 42 (100) 41 (95.3) .157 Complication 1 (2.4) 3 (7.0) .317 After 6 months GSV occlusion 42 (100) 41 (95.3) .157 Complication 0 1 (2.3) .320 Mean Total Follow-up (4.9 years) (n=29) (n=30) Total (4.5 - 5.1 years) GSV occlusion 26 (89.7) 20 (66.7) .001 Complication 0 (0) 3 (10.3) .127

[0061] . At the end of the procedure, four criteria with the Echo Intraoperative Doppler ultrasound was used by the same operator to determine the success of GSV thermal ablation. Petition 870250070126, dated 06 / 08 / 2025, page 19 / 26 14 / 15 reduction in lumen diameter, parietal thickening, lack of compressibility, and lack of flow in the treated segment due to distal enlargement in a segment >5 cm. After adequate hemostasis, the legs of all patients undergoing the procedures were bandaged with compression bandages (maintained for 48 hours), and patients were instructed to wear elastic stockings and encouraged to walk.

[0062] . Electroablation provided by ablation device 01 demonstrates efficacy and safety in GSV ablation, achieving a higher rate of venous occlusion compared to radiofrequency ablation (RFA) in long-term follow-up. Furthermore, the occurrence of complications and the impact on symptoms and quality of life were comparable between the two methods during long-term follow-up.

[0063] . As a result of the innovations of the present invention, the endovenous resistive heat ablation device represents an alternative with strong technical and economic potential to current technologies, combining desirable characteristics such as simplicity, effectiveness, safety and low cost. Its development and clinical validation can significantly contribute to making varicose vein treatments more accessible and efficient in different health contexts.

[0064] . Furthermore, the design of a device based on electrical resistivity also paves the way for the production of thinner, more flexible ablation catheters or probes that are more adaptable to venous anatomy, which could facilitate the treatment of more tortuous or smaller caliber veins. This could broaden the clinical indications for treatment and enable more versatile approaches and Petition 870250070126, dated 06 / 08 / 2025, page 20 / 26 15 / 15 less invasive.

[0065] . Having described examples of preferred embodiments of the present invention, it should be understood that the scope of the present invention encompasses other possible variations of the inventive concept described, being limited only by the content of the claims alone, including possible equivalents. Petition 870250070126, dated 06 / 08 / 2025, page 21 / 26

Claims

1 / 2 CLAIMS 1. Thermal chemical ablation device (1) for varicose veins characterized by comprising: - a conductive rod (2) connected to an electrical connector (3) by means of rigid welding; - the conductive rod (2) comprising an actuating basket (4) with malleable rings (5) fixed to said conductive rod (2) by welding; - a “Y” valve (6) that allows the infusion of sclerosing agents; Whereas said connector (3) is configured to be connected to a surgical electronic generator console and the conductive rod (2) is configured to conduct the power supply current from the console, so that the conductive rod (2) and actuator basket (4) are heated by the electric current and the actuator basket (4) is retractable through the rings (5), so that these contract in order to allow its introduction through a delivery catheter and once exposed outside the delivery catheter, the actuator basket (4) expands allowing its contact with the venous wall.

2. Ablation device (1) according to claim 1, characterized in that the conductive rod (2) is composed of a conductive element made of 304V stainless steel with a diameter between 0.3 mm and 0.7 mm.

3. Ablation device (1) according to claims 1 and 2, characterized in that the electrical connector (3) is an adaptable plug compatible with most models of electric scalpel pens available on the market, being selected from: terminals or specific connectors of existing electronic scalpel models.

4. A method for controlling the temperature of a varicose vein ablation device (1) as defined in claims 1 to 3, characterized by comprising the following steps: - providing an ablation device (1) comprising: - a conductive rod (2) connected to an electrical connector (3) by means of rigid welding; - the conductive rod (2) comprising an actuating basket (4) with malleable rings (5) fixed to said conductive rod (2) by welding;Whereas said connector (3) is configured to be connected to a surgical electronic generator console and the conductive rod (2) is configured to conduct the power supply current from the console, so that the conductive rod (2) and actuator basket (4) are heated by the electric current and the actuator basket (4) is retractable through the rings (5), so that these contract in order to allow its introduction through a delivery catheter and once exposed outside the delivery catheter, the actuator basket (4) expands allowing its contact with the venous wall; - connect said device (1) to an electronic scalpel generator console through connector (3); - configure the generator in coagulation function at a power of 20W to 100W. Petition 870250070126, dated 06 / 08 / 2025, pp. 23 / 26;

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