Patent RU-2749632-C1 (RU)
Title: Method of bilateral cryodenervation of the pulmonary arteries and a device for its implementation
Inventor: RUDENKO BORIS ALEKSANDROVICH
IPC: A61B18/02
Filed: 2020-05-21
Granted: 2021-06-16
Abstract: FIELD: medicine.SUBSTANCE: group of inventions relates to the field of medicine, cardiology and can be used in the treatment of pulmonary hypertension. The method of bilateral cryodenervation of the pulmonary arteries with a cryoballoon perfusion catheter includes: performing puncture of the right or left femoral veins under local anesthesia, installing introducer sheaths using the Seldinger technique. At the first stage, catheterization of the right heart is performed through the introducer in the left femoral vein. Tensometry of the pulmonary circulation is carried out using Svan-Gantz catheter 7Fr. To assess the invasive hemodynamic parameters, the systolic, diastolic, mean pressure in the right atrium, right ventricle, in the pulmonary artery, pulmonary artery wedge pressure, cardiac output by thermodilution, transpulmonary pressure gradient, diastolic pressure gradient are measured, while the parameters are monitored continuously throughout the entire operation. The second stage is pulmonary angiography to determine the anatomy and diameters of the right and left pulmonary arteries. After that, cryoballoon ablation of the orifices of the right and left pulmonary arteries is performed 1 cm from the bifurcation of the pulmonary trunk using a cryoballoon catheter with a size depending on the size of the right and left pulmonary arteries attached to the cryosurgical console. To do this, under fluoroscopic control on a 0.035 inch diagnostic guide wire inserted through the right femoral introducer using a pigtail diagnostic catheter and carried out as distally as possible to the level of the subsegmental branches, the pigtail diagnostic catheter is replaced with the right JR4.0 diagnostic catheter, which is fed to the distal end of the diagnostic guide wire. Then the diagnostic guide is replaced with a more rigid Amplatz Super Stiff (Boston Scientific). The JR4.0 diagnostic catheter is removed. Then a controlled introducer with a hemostatic valve and a dilator is brought along a stiffer guide wire to the level of the pulmonary trunk, the subsequent removal of the dilator is carried out, while the internal lumen of the introducer is compatible with the diameter of the cryoballoon catheter delivery system. After that, a cryoballoon catheter of the quick-change system with a round-shaped balloon with a diameter of 30 to 38 mm, depending on the diameter of the pulmonary artery, is put on the previously wound Amplatz Super Stiff metal guidewire. Then the cryoballoon catheter is brought along the guide through the guided introducer to the mouth of one of the main pulmonary arteries, while the cryoballoon catheter is positioned 1 cm distal to the mouth of the main pulmonary artery. Then the guided introducer is pulled 20 cm towards itself to release the opening of the quick-change system intended for the guidewire. Then the cryoballoon catheter is connected to the cryosurgical console with preset ablation parameters. Next, cryoinflation is carried out by inflating the cryoballoon with a cooling agent entering the expandable balloon through a channel with 8 holes located along the entire length of the cryoballoon catheter until a temperature of -60°C is reached. During cryoablation, the temperature is controlled using a temperature sensor isolated from the cold agent supply channel to the end of the cryoballoon catheter. When the balloon is inflated in the lumen of the vessel, a metal conductor is removed, passing in its own isolated channel, freeing the lumen for blood flow. A single application with duration of 240 seconds is carried out. Upon completion of the application, the supply of the cooling agent is automatically stopped by the cryosurgical console, after which the cryoballoon is deflated, then the cryoballoon catheter is completely removed. And again, a conductor is passed into the second pulmonary artery, and a cryoballoon catheter of the calculated size is passed through it, after which cryoballoon ablation of the other pulmonary artery is performed. At the end of the intervention, hemodynamic parameters are assessed using a Svan-Ganz catheter, while the effectiveness of the operation is determined by reducing the level of mPAP by more than 10%. The device for balloon cryodenervation of the pulmonary arteries is a cryoballoon perfusion catheter of the quick-change system, the body of which is made of a biocompatible copolymer with total length of 140 cm, consisting of a working part inserted into the body and a handle with a connector for connection to a cryosurgical console and containing an oval two-layer balloon, channel with 8 holes, baffle, a channel for a metal conductor, a thermocouple-based temperature sensor for temperature control during cryoablation. The oval double-layer balloon is made of polyurethane. The balloon diameter when inflated is from 30 to 38 mm, depending on the diameter of the pulmonary arteries and their anatomy in 2 mm increments. A channel with 8 holes is located along th