RU196638U1 - Device for intraoperative radio wave ablation with stem sclerotherapy of the main saphenous veins of the lower extremities - Google Patents

Abstract

The utility model relates to medicine, to vascular surgery, in particular to phlebology. The device can be used for intraoperative radio wave ablation with stem sclerotherapy in the treatment of varicose veins of the lower extremities, accompanied by valvular insufficiency of the main saphenous veins. For the first time, a device for intraoperative radio wave ablation with stem sclerotherapy of the main saphenous veins of the lower limbs with varicose veins is proposed. in length, corresponding to the length of the lower limb, made of dielectric, with metallic 8-shaped olive on the distal end connected to the radio-frequency equipment using an electric probe located inside the catheter, characterized in that the olive has a through hole along its axis, an additional dielectric tube is located in the catheter, the distal end of which enters the olive hole, and its proximal end is connected to the cannula for connecting the syringe to the sclerotherapy, the proximal end of the catheter being connected to the connecting sleeve, in which the connector for connecting the electric tricus probe and cannula connected to the inner tube. The positive effect of the proposed device is a more effective effect on the main saphenous vein due to the use of the second damaging factor - chemical (sclerotherapy), including veins of large diameter; the lack of need for the release of the main saphenous vein from blood due to the displacement of blood from the lumen of the vessel by a sclerotherapy in the form of foam, a reduction in the duration of surgery, rehabilitation in a shorter time.

Description

The utility model relates to medicine, to vascular surgery, in particular to phlebology. The device can be used for intraoperative radio wave ablation with stem sclerotherapy in the treatment of varicose veins of the lower extremities, accompanied by valvular insufficiency of the main saphenous veins.

In most modern intravascular methods for treating varicose veins, the surgical technique consists of puncture of the trunk of the saphenous vein at the end of the pathological vertical reflux, institution of the device to the safenofemoral or safenopopliteal anastomosis, and only then the damaging effect on the wall of the affected vein.

Among the known intravascular methods for varicose vein ablation, RFiTT (Radiofrequency-induced thermotherapy) technology - radio frequency-induced thermal bipolar obliteration and EVFR technology - radio frequency-induced monopolar obliteration are distinguished. When performing the RFiTT procedure, the electrodes are bipolar, using an alternating current generator, thermal effects on the vein wall in the range 70-100 * C occur [Goodyear S, Nyamekye I. Radiofrequency ablation of varicose veins: best practice techniques and evidence. Phlebology: The Journal of Venous Disease. 2015; 30 (2 suppl): 9-17. https://doi.org/10.1177/0268355515592771; Spiliopoulos S, Theodosiadou V, Sotiriadi A, Karnabatidis D. Endovenous ablation of incompetent truncal veins and their perforators with a new radiofrequency system. Mid-term outcomes. Vascular 2015; 23 (6): 592-598. https://doi.Org/10.1177/1708538114564462].

The disadvantages are:

- when the catheter is pulled quickly, the efficiency of processing the vein by RF exposure decreases;

- when slowly pulling, there is another drawback, which is the carbonization of the tip of the catheter between the two electrodes. Then the catheter is removed, cleaned and again inserted into the lumen of the vein to continue the procedure, which significantly lengthens the procedure time.

W, Milek Т, Myrcha Р, Migda В. Phlebogriffe - a new device for mechanochemical ablation of incompetent saphenous veins: a pilot study. Phlebological Review. 2015; 23(3):72-77. https://doi.org/10.5114/pr.2015.57466].A device for the treatment of varicose veins is known - Flebogrif®, the principle of which is to expose mechanical and chemical factors to the vein wall [Ciostek P, Kowalski M,

W, Milek T, Myrcha P, Migda B. Phlebogriffe - a new device for mechanochemical ablation of incompetent saphenous veins: a pilot study. Phlebological Review. 2015; 23 (3): 72-77. https://doi.org/10.5114/pr.2015.57466].

Flebogrif® is a device used to treat valvular insufficiency of the large and small saphenous veins in varicose veins. It is used for stem mechanochemical obliteration, when the large or small saphenous veins are mechanically damaged from the inside by the cutting elements of the catheter, while processing the veins with the help of a foamed sclerotherapy solution.

The Flebogrif® device is a single-channel catheter, into which a metal rod is inserted, to the distal end of which five thin, curved cutting elements are attached - “claws” with a diameter of about 0.3-0.5 mm. In working condition, these cutting elements form a kind of brush in shape that resembles a flower - a tulip, which when opened leads to mechanical damage to the vein endothelium. A syringe with a prepared dose of sclerotherapy in the form of foam is connected to the Flebogrif® catheter nozzle. The catheter moves uniformly to the periphery, at the same time, it is cut by the cutting elements of the vein endothelium and a sclerotherapy is introduced in the form of foam along the entire length of the obliterated vein.

The disadvantages of this device are:

- high probability of perforation of the wall of varicose veins due to cutting elements;

- and, as a result, the exit of the drug beyond the walls of the vessel during perforation of the venous wall;

- a small area of obviously necessary mechanical trauma to the inner surface of the vessel, which increases the risk of “skipping” or the appearance of undamaged sections of the endothelium of the vein.

The closest is, we previously proposed, a device for intraoperative radio wave ablation of the main saphenous veins of the lower extremities - patent No. 59416 dated 05/17/2006. A device for intraoperative radio wave ablation of the main saphenous veins of the lower extremities includes a metal probe with olive at its distal end, the length corresponding to the length of the lower limb, covered with a dielectric throughout, except for the olive, characterized in that the olive has an 8-shaped shape, and the probe is located inside the leg a, perforated over the entire length, internal diameter greater than the outer diameter of the probe, the proximal end of the catheter tightly sealed and has a cannula for attachment of the disposable syringe. The device is intended for intraoperative radio wave ablation of the large and small saphenous veins in the treatment of varicose veins of the lower extremities, accompanied by valvular insufficiency of the main saphenous veins. In this case, in order to reduce the risk of complications and increase the effectiveness of surgical intervention, the pre-main saphenous vein is released from the blood.

The disadvantages are:

- the need for the release of the main saphenous vein from the blood;

- the dependence of the effectiveness of the impact on the speed of movement of the device inside the vein. When the probe is pulled out quickly, the efficiency of processing the vein by RF exposure decreases — the appearance of insufficiently treated areas, and when the probe is pulled out slowly, the tip of the probe is charred.

We first proposed a device for intraoperative radio wave ablation with stem sclerotherapy of the main saphenous veins of the lower extremities in case of varicose veins.

When using the proposed device, higher treatment efficiency due to the use of two factors - physical and chemical. High impact efficiency, despite the rapid movement of the device, eliminating carbonization of the electrode.

The principle of operation of this device lies in the simultaneous damage to the vein wall by two acting factors - radio frequency exposure and chemical (sclerotherapy) on the vein wall.

The device we proposed is depicted in figure 1, where 1 is a catheter, 2 is an olive, 3 is an opening at the distal end of the olive, 4 is an inner tube for supplying a sclerotherapy, 5 is an electric probe, 6 is a connecting sleeve, 7 is a connector, for connecting to radio wave equipment, 8 - cannula at the proximal end for connecting a syringe.

A device for intraoperative radio wave ablation with stem sclerotherapy of the main saphenous veins of the lower extremities includes a flexible dielectric catheter with a length corresponding to the length of the lower extremity, the distal end of the catheter is hermetically connected to an 8-shaped olive with a through hole. The olive, using an electric probe located inside the catheter, is connected to a connector located inside the connecting sleeve mounted on the proximal end of the catheter. Inside the catheter there is a tube for supplying a sclerotherapy product, the distal end of which enters the olive hole, and its proximal end is connected to the cannula for attaching a syringe located in the connecting sleeve.

The technique of the surgical aid we have proposed includes the following algorithm: local anesthesia of the skin and subcutaneous tissue is performed in the projection of the border for the end of pathological reflux. In this place, under the control of ultrasonic angioscanning, the trunk is punctured by a large or small saphenous vein, an introducer is inserted through which the proposed device is passed. With the help of ultrasonic angioscanning, the device is positioned 2.0 cm lower than the safenofemoral or safenopopliteal anastomosis. The device is connected to the WAVETRONIC radio frequency apparatus, the following modes are used: Cutting and Coagulation. A sclerotherapy foam solution is prepared according to the Tessari method. A syringe with a foamed sclerotherapy is attached to the cannula of the device. Prior to electrode activation, anastomosis is performed by the sensor of the ultrasound apparatus. Simultaneously with the activation of the electrode, using the foot pedal, traction of the device and the introduction of the foamed sclerotherapy into the lumen of the vein are performed, as a result of which the blood is expelled from the vessel and there is no need for preliminary release of the lumen of the vein. Sclerotherapy is administered at a rate of 0.3-0.5 ml per 1 cm of varicose veins. During the procedure, the operated lower limb is in an elevated position. After the procedure, compression knitwear is applied.

As can be seen from the description of the positive effect of the proposed device in the following:

- a more effective effect on the large or small saphenous veins due to the use of the second damaging factor - chemical (sclerotherapy), including large veins;

- the lack of need for the release of the main saphenous vein from blood due to the displacement of blood from the lumen of the vessel by sclerotherapy in the form of foam;

- reducing the duration of surgery due to the sufficient speed of movement of the device;

- rehabilitation in a shorter time due to the puncture of the main saphenous vein, and not crossectomy, as when using the prototype.

Claims (1)

Device for intraoperative radio wave ablation with stem sclerotherapy of the main saphenous veins of the lower extremities, including a flexible catheter in length corresponding to the length of the lower extremity, made of a dielectric, with a metal 8-shaped olive at the distal end, made with the possibility of connection with radio-frequency equipment using an electric probe located inside the catheter, characterized in that the olive has a through hole along its axis, in the catheter an additional tube of di lektrika, wherein the distal end enters the opening olive and its proximal end connected to the cannula for attachment of the syringe with skleropreparatom, wherein the proximal end of the catheter is connected to the connecting sleeve, wherein the connector is for electric connection of the probe and the cannula, connected to the inner tube.

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