RU129387U1 - TRANSCATTER AORTIC VALVE BIOPROTHESIS IMPLANT SYSTEM - Google Patents

Abstract

The transcatheter system of implantation of the biological prosthesis of the aortic valve, consisting of a working tube, an implant control handle and a flexible tube-connector, while the working tube contains a biological valve prosthesis and consists of a central hollow shaft connected at the ends with two supporting elements, in addition, the proximal end the working tube is connected to the base of the final cone, and the implant control handle is represented by a hollow cylinder containing a lever and an adjusting wheel, characterized by m, that on the distal supporting element of the working tube is made of at least one protruding rectangular retainer.

Description

The utility model relates to the field of medicine, namely to surgical instruments, and can be used in cardiac surgery to position the biological prosthesis of the aortic valve mounted on a rigid support frame using the minimally invasive transfemoral method.

Reconstructive operations on heart valves occupy one of the leading places among heart operations. The most common cause of aortic valve dysfunction requiring surgical correction is rheumatic calcified valvular stenosis. Moreover, the favorable outcome of surgical intervention depends on many specific risk factors: concomitant diseases, heart failure, pulmonary hypertension, already undergone heart surgery, patient age. Until now, aortic valve replacement in this category of patients has been performed through open heart surgery. Reducing the risk of surgical intervention is achieved by using the minimally invasive transcatheter implantation technique, which significantly improves the patient’s hemodynamic status and, unlike open surgery, does not involve torocotomy, the use of cardiopulmonary bypass and mechanical ventilation, aortotomy, and often general anesthesia. The transcatheter delivery system for the aortic valve bioprosthesis is a structurally complex product and can significantly simplify the procedure for installing the bioprosthesis and increase its accuracy.

A known aortic valve bioprosthesis delivery system (Low profile delivery system for transcatheter heart valve: USA Appl. 20090281619; fil. 08.10.08; pub. 12.11.09), which is a working tube with a cylinder mounted on it, connected to the control handle and having additional findings for contrast and conductors. The balloon is designed to actively inflate the supporting frame of the bioprosthesis, crimped on it (balloon) before the implantation procedure. The inflation rate is controlled by a fluid pressure regulator on the control handle. After installing the bioprosthesis, the balloon is deflated, and the delivery system is removed from the patient's body.

The disadvantage of this technical solution is the inability to reverse the implantation procedure after the bioprosthesis is inflated, due to the occurrence of irreversible deformation of the support frame and elements of the delivery system intended for this purpose.

Closest to the claimed device is a delivery system (Delivery and retrieval systems for collapsible / expandable prosthetic heart valves: USA Appl. 20100286768; fil. 08.01.09; pub. 11.11.10), consisting of a circular working tube with spindle-shaped broadening of various lengths , in which there is a prosthesis intended for implantation, an implantation control handle and a tube connecting these elements into a single system. The end of the working tube has a rounding to prevent injury to the vascular wall, as well as a protective casing covering the bioprosthesis to prevent its dislocation during passage of the vascular bed. After reaching the implantation site, the protective casing is shifted, and the bioprosthesis takes its form at the root of the aorta. The speed of release and installation of the prosthesis is controlled by the control handle.

The disadvantage of this technical solution is the lack of prosthesis attachment elements in the delivery system, which can lead to unnecessarily fast and uncontrolled extraction of the biological prosthesis, and as a result, incorrect positioning.

The technical result of the utility model is to increase the reliability of fixation of a biological prosthesis and control of the implantation procedure due to the presence of bioprosthesis fixators in the delivery system, coaxial and commensurate with the fixators located on the distal part of the bioprosthesis support frame.

A system for transcatheter implantation of an aortic valve bioprosthesis consisting of a working tube in which a biological prosthesis, an implant control handle and a flexible connector tube connecting these elements of the system are proposed. In this case, the working tube of the implantation system is represented by a central hollow rod connected to two supporting elements by means of end extensions.

The difference is that at least one retainer is made on the distal support element of the working tube, protruding above the surface of the support element in the form of rectangles and intended for reliable fastening of the bioprosthesis.

The elements of the working part and the connector tube are made of a non-toxic biocompatible polymer intended for short-term interaction with the patient's body, for example, PTFE or Teflon. The elements of the implant control handle are made of non-toxic plastic approved for medical use, for example, PTFE or polypropylene. The production of elements of the implantation system is carried out by extrusion, molding or casting, and the connection of the elements of the delivery system among themselves is carried out by mechanical, thermal or chemical methods.

The essence of the utility model is illustrated by drawings, where:

figure 1 shows a General view of the transcatheter system of implantation of a bioprosthesis of the aortic valve;

figure 2 the appearance of the working tube without an outer casing;

figure 3 the appearance of the working tube;

in Fig.4 an implantation system with an aortic valve prosthesis fixed to it;

figure 5 shows the implantation system with a partially extracted aortic valve prosthesis;

figure 6 shows a longitudinal section of the implant control handle.

The working tube 1 of the transcatheter implantation system consists of a central hollow rod 2 having conical broadening at both ends. The Central rod 2 is connected to the supporting elements 3 and 4, which are equal in diameter and are designed to maintain the cylindrical shape of the supporting frame of the bioprosthesis. In this case, the supporting element 4 is located at the proximal (relative to the heart) end of the working tube 1 and is connected to the base of the final cone 5, on the top of which an opening 6 is made for a standard conductor used for minimally invasive surgical interventions.

The supporting element 3, located at the distal end of the working tube 1 and contains clamps 7 for holding the biological prosthesis 8 in the delivery system. The latches 7 are aligned and proportional to the latches 9, made on the frame of a biological prosthesis 8.

Outside, the working tube 1 is closed by the outer casing 10 to protect the bioprosthesis 8 fixed in the system. The casing 10 is connected to the tube-connector 11 by constricting 12 and, when the implant control handle 13 is manipulated, moves distally, releasing the prosthesis 8.

The tube-connector 11 contains a conductor and interconnects the working tube 1 and the implant control handle 13.

The implant control handle 13 is a hollow cylinder, inside of which there is a screw-threaded rod 14 connected to the lever 15. The lateral surfaces have slotted holes to provide access to the lever 15. By manipulating the lever and the wheel alternately, the surgeon achieves the accuracy and optimal opening speed of the biological prosthesis .

At the distal end of the handle is a control wheel 16, which serves to more accurately control implantation. The screw rod 14 is connected to the tube-connector 11 and allows you to control the position of the casing 10 by manipulating the lever and / or wheel.

Before packing into the implantation system, the biological prosthesis 8 of the aortic valve mounted on a rigid frame is cooled in a container with physiological saline at a temperature of at least + 15 °. This temperature allows the support frame of the prosthesis to become plastic due to a change in the structure of the crystal lattice during cooling. The prosthesis is compressed mechanically and placed in the working part 1 using the clips 7 and 9, after which the protective casing 10 is put on.

During surgery, a conductor is inserted transfemorally into the femoral artery, which reaches the aortic ring, then the working tube 1 is followed along the conductor. After the working tube 1 of the implantation system is positioned in the necessary position relative to the aortic root, the prosthesis 8 is removed by changing the position of the casing 10 by manipulating the lever 15 and the wheel 16. In this case, the casing 10 is pulled in the distal direction and the proxy is gradually released in a controlled manner the small end of the prosthesis 8 valve of the aorta. The prosthesis is retained in the implantation system due to the fixing elements 7 of the working tube and 9 of the supporting frame of the biological prosthesis. After tightening the protective casing 10 distal to the retainers 7, the prosthesis 8 is completely released and its opening due to the accumulated potential energy. In this case, the function of the native cusp apparatus is transferred to the artificial cusps of the prosthesis of the aortic valve 8. After installing the prosthesis in the required position, the implantation system and the conductor are removed from the aorta.

Claims (1)

The transcatheter system of implantation of the biological prosthesis of the aortic valve, consisting of a working tube, an implant control handle and a flexible tube-connector, while the working tube contains a biological valve prosthesis and consists of a central hollow shaft connected at the ends with two supporting elements, in addition, the proximal end the working tube is connected to the base of the final cone, and the implant control handle is represented by a hollow cylinder containing a lever and an adjusting wheel, characterized by m, that on the distal supporting element of the working tube is made of at least one protruding rectangular retainer.

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