RU2427396C1 - Cardiosurgical complex for coronary stenting - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medical equipment. A cardiosurgical complex comprises a stent placed on a balloon catheter in the form of a tube. On a distal end of said tube, there are available a balloon segment and radiopaque markers limiting its length. The balloon catheter has a shaft for a first coronary conductor, a shaft for a contrast medium and a longitudinal through passage for a second coronary conductor. The latter represents a flexible tube which is outside of the balloon segment and the stent in the immediate proximity thereto along the tube of the balloon catheter and contacting it along the whole length of the flexible tube for the second conductor. The flexible tube is provided with an inlet in a termination point of the proximal side of the balloon segment and has length 15-30 cm.

EFFECT: cardiosurgical complex allows eliminating stenosis with high-accurate stent positioning when the stenosis is arranged: in an artery mouth or in a point immediately after origin of a lateral artery.

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Description

The invention relates to medical equipment, namely to medical and surgical instruments and cardiac surgery. It can be used to eliminate stenosis of the coronary arteries in a hospital of cardiological and cardiosurgical units in the provision of highly professional surgical assistance.

The cardiac surgery complex includes a stent placed on a balloon catheter. Balloon catheters have structural differences, as well as stents. Therefore, the improvement of cardiac surgery complexes follows the path of either changing the stent - the first path, or balloon catheter - the second path. This invention proposes the improvement of a cardiac surgical complex in a second way.

Known balloon catheters used in endovascular cardiac surgery, including cardiac surgery complexes [Babunashvili A.M., Rabkin I. X., Ivanov V.A. Coronary Angioplasty - M .: DIA Publishing House, 1996. - 352 pp., Ill.], Have two lumens: a central one for introducing a coronary conductor and an additional one communicating with the balloon segment of the catheter. The diameter of the base catheter ranges from 1.5 F (for single-lumen balloon catheters) to 4.3 F (for double-lumen catheters). The length of balloon catheters varies from 115 to 135 cm. The balloon catheter has a balloon segment at the distal end, its length is from 10 to 40 mm, the diameter of the balloon segment of the catheter ranges from 1.5 to 4.2 mm. The main materials used for the manufacture of balloon segments of catheters are polyethylene (PET) and polyvinyl chloride (PVC). An important characteristic of a balloon catheter is the ratio of the balloon segment (in the collapsed state of the balloon) and the diameter of the base catheter. The main types of balloon catheters used in clinical practice can be divided into two groups:

- double-lumen balloon catheters ("balloon on the conductor"): when using these types of balloon catheters, it is possible to separately conduct the coronary conductor into the central lumen of the catheter and independently control the conductor;

- monorail balloon catheters that do not have a double lumen throughout, their conductor shaft ends at a distance of 6-8 cm from the distal tip of the catheter.

Known cardiac surgery complex, the stent of which is placed on a double-lumen balloon catheter. It has a central guide shaft extending along the entire length of the balloon catheter, and a shaft for supplying contrast medium to the balloon segment. He and all other balloon catheters exclude the possibility of delivery of the stent to the site of stenosis simultaneously along two coronary conductors.

With all the variety of design features, all balloon catheters have one common detail: the presence of a single shaft for the coronary conductor. However, a number of techniques have been developed for angioplasty and stenting of the coronary arteries, in which a coronary stent fixed on a balloon catheter is delivered to the stenosis site simultaneously through two conductors.

A well-known technique for elimination of wellhead stenosis is used in the Szabo technique [information materials are attached, Szabo technique versus conventional angiographic placement in bifurcations 010-001 of Medina and in aorto-ostial stenting: angiographic and procedural results. Juan Luis Gutierrez-Chico et al. // EuroIntervention, 2010; 5: 801-808]. The author of Szabo improvisedly creates the possibility of the passage of the second conductor, manually forming a through channel of the input and output of the second conductor, limiting itself to just one proximal cell of an industrially manufactured standard stent.

The closest analogue to the claimed invention is the “Cardiac Surgery Complex for Coronary Stenting” [RU patent for invention No. 2224555 of the same applicant as the application filed in this material, application filing date 12/28/2001, patent grant date 08/27/2003. ]. It consists of a stent placed on a balloon catheter, which is made in the form of a tube, at the distal end of which there is a balloon segment and radiopaque marks that limit its length. The balloon catheter has a shaft for the coronary conductor and a shaft for contrast medium. A longitudinal channel is formed under the stent on the outer surface of the balloon segment for its passage for the passage of the second coronary conductor in the form of a longitudinal recess. Despite the more reliable constructive elaboration of this complex in the closest analogue, in comparison with the foreign analogue, in both there remains the possibility of deformation of the stent structure. In addition, the introduced improvements increase the transverse profile of the stent design on the balloon, which creates additional difficulties when holding the stent to the stenosis site, and the possibility of losing the stent due to its displacement from the balloon segment is not ruled out.

The objective of the invention is to develop a cardiac surgical complex that allows you to eliminate stenosis with high accuracy stent positioning in cases of stenosis at the mouth of the artery or in the place immediately after the departure of the lateral artery.

The essence of the invention lies in the fact that in a cardiac surgical complex for coronary stenting, which includes a stent placed on a balloon catheter in the form of a tube, at the distal end of which there is a balloon segment and radiopaque labels that limit its length; the balloon catheter has a shaft for the first coronary conductor, a shaft for contrast medium and a longitudinal passage for the second coronary conductor, the latter is made in the form of a flexible tube located outside the balloon segment and the stent in close proximity to them, located along the tube of the balloon catheter and in contact with it over the entire length of the flexible tube for the second conductor, while the flexible tube is made with the entrance at the end of the proximal side of the balloon segment and has a length of 15-30 cm.

The technical result of the claimed invention is to ensure the accuracy of the stent positioning in two cases of stenosis at the mouth of the artery or in the place immediately after the lateral artery has departed due to reliable fixation of the stent in the stenosis site by the second conductor standing in the lateral artery. The technical result is achieved by the technical method, which consists in the development of a special design in which the longitudinal passage for the second coronary conductor is made in the form of a tube with an entrance from the proximal side of the dilatation segment directly in front of it. In addition, unlike the closest analogue, the through passage for the second coronary conductor is not made in the stent, not in its cell, but is moved outside it, which does not deform the stent and does not increase its transverse profile.

The inventive cardiac surgery complex for coronary stenting is illustrated using the drawing, where the positions indicate: 1 - coronary conductor, 2 - shaft for the first coronary conductor, 3 - stent, 4 - balloon segment, 5-flexible tube for the second coronary conductor, 6 - entry point second coronary conductor.

The inventive cardiac surgical complex for coronary stenting includes a stent 3 and a balloon catheter. The latter is made in the form of a base tube, at the distal end of which there is a balloon segment 4 and radiopaque marks that limit its length. The balloon catheter has a shaft 2 for the first coronary conductor 1, a shaft for the contrast medium and a flexible tube 5 for the second coronary conductor, made outside the stent 3 and the balloon segment 4 parallel to the base tube of the balloon catheter, in close proximity to the stent 3, mounted on the balloon segment 4, but not touching it and the stent 3. Tube 5 for the second conductor, with its entire length, is in direct contact with the base tube, in which two shafts are located - shafts 2 for the first conductor 1 and a contrast agent for inflating the balloon. The length of the tube for the second conductor is less than the lengths of the shafts for the first conductor 1 and the contrast medium and is about 15-30 cm. The inlet of the tube 5 for the second conductor is in close proximity to the balloon segment 4, from its proximal side.

The practical use of the inventive cardiac surgery complex for coronary stenting

Previously, two coronary conductors are inserted into the patient. The first conductor 1 is led into the main artery, the second into the lateral. Then, the claimed cardiac surgical complex is simultaneously put on both conductors. The first conductor 1 passes through the central shaft 2 of the balloon catheter, the second leads into a formed tube 5 located outside the balloon stent 3 and segment 4. The inlet 6 of the additional tube 5 (for the second conductor) introduced in this solution is located on the side of the proximal part of the balloon segment 4 near him. The stopping place in the advancement of the cardiac surgical complex is the place immediately after the branching of the arteries with the stenosis located in it. A factor limiting the further promotion of the claimed complex is the second conductor located in the lateral artery. This moment ensures the accuracy of positioning of the stent 3 at the site of stenosis, unlike analogues and prototype. A stent 3 is implanted into the main artery by inflating the balloon segment 4 of the balloon catheter. After the implantation of the stent 3 is completed, the procedure is completed by removal of the balloon catheter and two conductors from the coronary arteries.

The inventive cardiac surgical complex solves the problem of eliminating stenosis located at the mouth of the coronary artery, as well as in the place immediately after the departure of the lateral artery.

Example

The claimed invention is additionally constructively practiced in the form of a model in the conditions of the scientific laboratory of the Saratov Scientific Research Institute of Cardiology.

Claims (1)

Cardiac surgical complex for coronary stenting, including a stent placed on a balloon catheter in the form of a tube, at the distal end of which there is a balloon segment and radiopaque marks that limit its length, the balloon catheter has a shaft for the first coronary conductor, a shaft for contrast medium and a longitudinal through for the second coronary conductor passage, characterized in that the latter is made in the form of a flexible tube located outside the balloon segment and the stent in the immediate vicinity bridges to them, located along the tube of the balloon catheter and in contact with it along the entire length of the flexible tube for the second conductor, while the flexible tube is made with an entrance at the end of the proximal side of the balloon segment and has a length of 15-30 cm.

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