RU236962U1 - Device for transfemoral delivery via the femoral artery and release of a balloon-expandable transcatheter aortic heart valve prosthesis - Google Patents

Abstract

The utility model relates to the field of interventional cardiac surgery and can be used for transcatheter interventions on the aortic valve. The system is designed for transfemoral delivery through the femoral artery and release of a balloon-expandable transcatheter aortic heart valve prosthesis in the implantation zone without deformation of the frame and violation of the integrity of the cusps. Such a system allows performing reconstructive surgeries on valves in patients previously considered inoperable. The technical result of the utility model is achieved by equipping the internal mechanism of the delivery system handle with a stopper to prevent displacement of the threaded sleeve with a tension wire during operation, the presence of front and rear conical covers on the handle body for improved grip and increased ergonomics, replacing adhesive joints with threaded ones to increase the strength, reliability of the connections and simplify the technological process of assembling the handle. The transfemoral system for delivering a balloon-expandable transcatheter aortic heart valve prosthesis includes the following components: a balloon with a distal tip, catheters with different hardness, a handle with an internal bending mechanism, distal and proximal couplings, a coupling for the connector, a connector with a Luer-type connector. A distinctive feature of the delivery system is an improved handle that provides improved control of the bending mechanism, ergonomics and reliability, due to the equipment of the internal mechanism with a stopper, the presence of front and rear conical covers on the body, as well as the replacement of adhesive connections with threaded ones.

Description

The utility model relates to the field of interventional cardiac surgery and can be used for transcatheter interventions on the aortic valve.

The system is designed for transfemoral delivery via the femoral artery and release of a balloon-expandable transcatheter aortic heart valve prosthesis in the implantation area without deformation of the frame and damage to the integrity of the valve leaflets. This system allows reconstructive surgeries on valves in patients previously considered inoperable.

The transfemoral balloon-expandable transcatheter aortic heart valve prosthesis delivery system is a high-tech catheter equipped with specialized mechanisms for precise delivery, positioning, placement and installation of a transcatheter artificial valve into the cardiac cavity. This delivery system provides minimally invasive intervention, reducing patient recovery time and reducing the risk of complications. The main components of the simplest heart valve delivery system usually include: a distal tip, a deployment mechanism (balloon or mechanical drive), a catheter and/or catheters of different hardness, with different coatings, a guidewire, a control (handle), a connector.

Since the invention of the transcatheter valve by the Danish physician and inventor Henning Ruud Anderson (Patent US 5411552 A) and the first transcatheter replacement surgery for a patient with severe aortic valve stenosis, performed in 2002 under the guidance of the French cardiologist Alain Cribier, a large number of studies have been conducted around the world devoted to the development of new models of transcatheter valves and devices for their delivery [1-23]

There are transcatheter delivery devices for replacing the aortic valve prosthesis based on the use of a self-expanding support frame made of titanium nickelide (nitinol) (e.g., patents US 6143021, US 11896486 B2, RU 129387 U1, US 11414657) [24-27]. In these devices, the aortic valve prosthesis is a self-expanding stent made of nitinol, to which valve leaflets made of biological material or synthetic polymers are fixed. The prosthesis has the ability to be compressed to a small diameter for passing through the vessels and then opening in the area of the aortic valve under the action of the elastic properties of nitinol.

A special feature of delivery systems for such self-expanding prostheses is the presence of a catheter with a retaining element that ensures that the prosthesis remains compressed while passing through the vascular bed. This is usually achieved by placing the prosthesis inside an external casing or by means of a special retaining thread. Upon reaching the implantation area, the retaining element is removed or the casing is retracted, allowing the prosthesis to open independently and take the required position. At the same time, the design of the delivery system for self-expanding prostheses should ensure control over the position and orientation of the prosthesis during implantation, minimize the risk of vascular damage, and be compatible with various sizes and shapes of the vascular bed. Flexible materials, special tips, and mechanisms for controlling the advancement and rotation of the catheter are used for this purpose.

For example, the Boston Scientific "ACURATE neo" valve delivery system is well known. The design features include the use of a flexible catheter, which reduces the risk of vascular complications. The presence of a radiopaque stent holder, which serves as a reference for positioning. The top-down deployment mechanism ensures stable and predictable valve opening. Two rotating handles, with which you can step-by-step and easily perform implantation. A safety button that prevents premature implantation. The delivery system can also bend in two planes due to the control handle, which allows you to pass complex anatomical bends and angles of the aorta, as well as center the system in relation to the long axis of the aortic valve.

In addition to delivery systems for self-expanding prostheses, there are also balloon-expandable delivery systems, in which the opening of the heart valve prosthesis is carried out by expanding a special balloon under the required pressure. This allows the use of more rigid materials for the prosthesis frame and provides additional control over the implantation process.

Today, some of the leading manufacturers of transcatheter heart valves and valve delivery systems that have received the greatest distribution and approval in the world are: Edwards Life Sciences Inc., USA (valve models: "Edwards SAPIEN XT"; "Edwards SAPIEN 3"; delivery systems: "novaFlex plus"; "Commander" for transfemoral access and "Certitide" for transapical access); Medtronic Core Valve Inc., USA (valve model "Core Valve Evolut R", delivery system "EnVeo R")., St. Jude Medical, USA (currently Abbott Laboratories) (valve model "Portico", delivery system "FlexNav"), Boston Scientific (valve model "Lotus Edge", delivery system "Lotus Edge Valve System"), JenaValve Technology, Germany (valve model "The Trilogy Valve"), delivery system "The Trilogy Delivery System))).

The balloon-expandable delivery system "FlexNav" from Abbott Cardiovascular for the procedure of transcatheter implantation of the valve "Portico" is known. The design features of the system include the presence of an integrated sheath on the catheter, which allows for relatively easy penetration into the vascular system (access to vessels with a diameter of more than 5.0 mm) and maintains a low insertion profile (4.70 mm-5.00 mm or 14 French (Fr)-15 French (Fr)). A hydrophilic coating on the inserted length of the delivery system reduces the surface friction properties of the catheter and facilitates passage through tortuous vessels. A redesigned handle with an automated deployment locking mechanism, increased mechanical advantage (less force per turn) and a dedicated macroslide function simplify the user interface and provide an optimized workflow.

The novaFlex plus delivery system for the Edwards Lifesciences SAPIEN XT valve is known. The design features of the system include a flexible wheel for the hinged connection of the flexible catheter, a conical tip at the distal end of the delivery system to facilitate advancement to the right ventricular outflow tract. The handle of the system has a flexibility indicator, a wheel for fine-tuning the transcatheter heart valve during its alignment, a button that allows movement between handle positions, and a port for flushing the flexible catheter. The balloon catheter has radiopaque markers that determine the valve alignment position and the working length of the balloon. A dual radiopaque marker proximal to the balloon indicates the position of the flexible catheter during deployment.

Known is the patent US 11896486 B2 for a system for delivering a transcatheter heart valve prosthesis [28]. The device is a delivery system consisting of the following main structural elements: a handle, a hollow shaft, a distal tip, and a drive mechanism for moving the valve to the distal tip. A distinctive feature of the system is the presence of a tool for crimping the valve, consisting of a hollow conical element, a removable transition tube, and a traction device. The expanded valve prosthesis is inserted into the conical element through its base and is compressed as it passes, entering the transition tube.

The advantages of the system include a simplified process of loading the valve into the delivery system, a reduced risk of damage to the prosthesis due to controlled compression through a conical element.

The disadvantages of this device include the presence of additional components, which in turn can complicate the design and increase the number of assembly stages. Also, the disadvantages include the need for precise alignment of elements when connecting the tube and the conical element, as well as the risk of deformation of the heart valve prosthesis if the traction device is used incorrectly.

Domestic developments are also known.

A device for transfemoral delivery of a balloon-expandable heart valve prosthesis from Medinzh is known (patent RU 2763828 C1) [29]. The basic design of the delivery device includes: a balloon catheter with a balloon fixed to it, on which the heart valve prosthesis is installed, a handle containing a slider with a stopper for moving the outer catheter relative to the balloon catheter, a screw with a nut connected to the balloon catheter for precise adjustment of its position, sealing elements to prevent blood leakage, a connector with channels for feeding fluid into the balloon and passing a conductor.

The advantages of this device include the presence of a balloon catheter, which allows the prosthesis to be carefully installed in the desired position, ensuring effective replacement of the damaged valve. Also, the presence of sealing elements and a drain valve prevent blood leakage and air from entering the patient's blood, reducing the risk of complications associated with bleeding or air embolism.

The disadvantages of the device include the need for careful tightness control. Despite the fact that the device is equipped with sealing elements, any defect in them may lead to unwanted blood leakage or air ingress, which requires careful checking before use. Also, excessive rigidity or insufficient flexibility of the balloon catheter may limit the ability to access certain areas of the heart, especially in patients with anatomical features of the vessels. In addition, moving mechanical parts may be subject to wear or breakage, which may lead to unforeseen complications during the critical phase of prosthesis installation.

The closest to the claimed technical solution is the Myval Navigator delivery system from Meril Life Sciences (patent US 20220151781 A1) [30]. The design features of the system include the presence of proximal and distal stoppers inside the balloon, which in turn ensure precise positioning and tight compression of the valve. The presence of stoppers also prevents accidental migration of the valve and the risk of its displacement (embolization) during entry through the sheath or when passing a loaded delivery system through the aorta. The use of catheters of different hardness, made using stainless steel braiding, provides the necessary flexibility of the system, allowing to minimize damage to the anatomy of the arch during passage.

The disadvantages of the system include the use of adhesive joints in the handle of the delivery system, which, despite the reduction in production costs, can lead to a decrease in the reliability of the structure, especially when exposed to physiological fluids, which can cause depressurization of the joints. Also, the design of the handle may not be ergonomic enough, which complicates the control of the delivery system and reduces the accuracy of positioning the heart valve prosthesis. In addition, as noted by cardiac surgeons when using this system, the length of the delivery system is not always sufficient, as a result of which access to various anatomical positions of the heart is not provided, while ease of use for the surgeon plays a critical role in reducing the time of the procedure and increasing its success.

Based on the set of described disadvantages and the supposed reasons for their occurrence, the technical result of the proposed utility model is the creation of a transfemoral system for delivering a balloon-expandable transcatheter aortic heart valve prosthesis, the distinctive feature of which is an improved handle providing improved control of the bending mechanism, ergonomics and reliability. The declared distinctive features are implemented due to a number of design changes in the handle, namely: equipping the internal mechanism of the handle with a stopper preventing displacement of the threaded sleeve on which the tension wire is fixed. This stopper is made in the form of a cylindrical sleeve, the internal through hole of which is equipped with two limiting projections (R 0.5 ± 0.1 mm), which fix it in a given position on the guide rod, thereby excluding arbitrary displacement of the threaded sleeve with the tension wire during operation. This solution ensures stability of the wire tension, which is critically important when operating the bending mechanism of the distal part of the delivery system. Another distinctive design feature is that the pen body is equipped with front and rear conical covers. The front conical cover, with a maximum diameter of 30 mm, is built into the swivel wheel, which, in turn, is integrated into the pen body with a diameter of 35 mm. These dimensions were selected taking into account the basic requirements of ergonomic design (GOST R 56274-2014) and the average hand size (GOST R ISO 7250-3-2019), which in turn ensures satisfaction with control and minimizes operator fatigue during prolonged manipulations during surgery. The conical shape of the front and rear covers not only improves tactile perception, but also provides a more secure grip by hand, preventing slipping. Also, a distinctive feature of the proposed model is the replacement of adhesive joints in the pen mechanism with threaded ones. This replacement not only ensures the strength of the joints and the reliability of the structure, but also simplifies the technological process of assembling the pen, eliminating the need for glue.

The technical result of the utility model is achieved by equipping the internal mechanism of the delivery system handle with a stopper to prevent displacement of the threaded sleeve with the tension wire during operation, the presence of front and rear conical covers on the handle body for improved grip and increased ergonomics, replacing adhesive joints with threaded ones to increase the strength, reliability of the connections and simplify the technological process of assembling the handle.

A transfemoral system for delivering a balloon-expandable transcatheter aortic heart valve prosthesis is proposed, which includes the following components: a balloon with a distal tip, catheters with different hardness, a handle with an internal bending mechanism, distal and proximal couplings, a coupling for a connector, and a connector with a Luer-type connector.

A distinctive feature of the delivery system is the improved handle, which provides improved control of the bending mechanism, ergonomics and reliability, thanks to the equipment of the internal mechanism with a stopper, the presence of front and rear conical covers on the body, as well as the replacement of adhesive joints with threaded ones.

The essence of the utility model is explained by the drawings:

Fig. 1 shows a fragment of the drawing of the transfemoral delivery system of the balloon-expandable transcatheter aortic heart valve prosthesis in assembly, where: 1 - assembled balloon, 2 - distal catheter, hardness 55D (according to Shore), 3 - proximal catheter, hardness 72D (according to Shore), 4 - distal handle coupling, 5 - delivery system handle, 6 - proximal handle coupling, 7 - proximal catheter, hardness 35D (according to Shore), 8 - connector coupling, 9 - connector with a Luer type connector.

Fig. 2 shows a fragment of a drawing of a transfemoral system for delivering a balloon-expandable transcatheter aortic heart valve prosthesis in assembly, where: 10 is a tension wire secured inside handle 5 passing through catheter 3 and 2 and fixed on a radiopaque marker - 18.

Fig. 3 shows a fragment of a drawing of a balloon assembly of a transfemoral delivery system for a balloon-expandable transcatheter aortic heart valve prosthesis, where: 11 is an inner tube, 12 is a soft distal tip, 13 is a balloon, 14 is a support tube, 15 are radiopaque markers inside the balloon, 16 are valve stoppers, 17 is a balloon tube, 18 is a radiopaque marker on which tension wire 10 is fixed.

Fig. 4 shows a fragment of the drawing of the handle (5) of the transfemoral system for delivering a balloon-expandable transcatheter aortic heart valve prosthesis in assembly, where: 19 - front cover, 20 - rotary wheel, 21 - handle body, 22 - rear cover, 23 - protective panel, 24 - indicator, 25 - threaded sleeve, 26 - threaded sleeve on which the tension wire (10) is initially secured, 27 - stopper, 28 - guide rod.

Fig. 5 shows a fragment of a drawing of a distal catheter with a hardness of 55D (according to Shore) 2 in assembly, where: 29 - outer coating of the catheter (hydrophobic); 30 - outer layer; 31 - braid; 32 - inner coating of the catheter.

The claimed transfemoral system for delivering a balloon-expandable transcatheter aortic heart valve prosthesis is intended for transcatheter prosthetics and delivery of a heart valve using a balloon implantation method.

Structurally, the delivery system (Fig. 1) is an assembled balloon 1, which is attached to the outer surface of a distal catheter with a hardness of 55D (according to Shore) 2. In turn, the catheter 2 is connected to a proximal catheter with a hardness of 72D (according to Shore) 3. The process of butt jointing of catheter 2 with catheter 3 is carried out using a heat-shrinkable connection method using fluorinated ethylene propylene heat-shrinkable tubing, which after shrinkage corresponds to the diameter of the catheters (4.67 mm, 14 Fr, French). This butt joint method allows for the creation of a reliable and smooth connection between the catheters. A distal handle coupling 4 and a control mechanism - a delivery system handle 5 are mounted on a proximal catheter 3. Inside the handle body 5, a proximal catheter 2 is connected to a proximal catheter with a hardness of 35D (according to Shore) 7, also by a heat-shrinkable connection method using fluorinated ethylene propylene. A proximal handle coupling 6, a connector coupling 8 and a connector with a Luer connector type 9 are mounted on the catheter 7. The connector with a Luer connector type 9 is attached to the outer surface of the catheter tube 7 using glue and ultraviolet curing. Also, the junction between the connector 9 and the catheter 7 is covered with a heat-shrinkable tube. This is necessary to reduce the tension between the connector and the catheter in order to prevent kinking of the inner tube 11, which in turn runs the entire length of the delivery system (from the balloon to the Luer connector). Tension wire 10 is fixed inside catheter 2 on radiopaque marker 18, passes through catheters 2, 3 and is secured inside handle 5.

The assembled balloon 1 in contact with blood (Fig. 3) is a structure consisting of the following components: a soft distal tip 12 made of polyurethane and in contact with blood is mounted on the surface of the inner tube 11 made of stainless steel (grade "AISI 304L"), coated with polyimide and not in contact with blood; a balloon 13 made of high-viscosity polyamide (grade "Vestamid ML Care 21") and in contact with blood is attached to the proximal part of the tip 12. The neck of the balloon 12 is attached to the outer surface of the distal tip using a heat-shrinkable connection using fluorinated ethylene propylene. Also mounted on the surface of the tube 11 are: a support tube 14 made of polyurethane and not in contact with blood; three radiopaque markers 15 made of platinum-iridium alloy, two of which are located at the distal and proximal ends of the balloon, and one in the center of the balloon; two valve stoppers 16 made of polyurethane that do not come into contact with blood; a balloon tube 17 made of polyurethane and that does not come into contact with blood; a fourth radiopaque marker 18 located at a distance of 40±0.5 mm from the proximal edge of the balloon neck. The neck of the proximal edge of the balloon 13 is attached to the outer surface of the catheter 2 using a heat-shrinkable tube made of fluorinated ethylene propylene, wherein the radiopaque marker 18 with a tension wire 10 attached to it by soldering is built into the inner part of the catheter tube 2.

The second integral part of the delivery system is a distal catheter with a hardness of 55D (according to Shore) 2 contacting with blood (Fig. 5). Catheter 2 is a multicomponent medical tube consisting of: an outer, transparent, hydrophobic coating 29, 100 μm thick, made of high-viscosity polyamide (brand "Vestamid ML Care 21"); an outer layer of the catheter 30, made of a thermoplastic elastomer made of flexible polyester and rigid polyamide (brand "Pebax 6333"); a braid 31 with a diameter of 3.7 mm (11 Fr, French) made of wire the material of which is stainless steel grade 304 (braid configuration - 0.001 × 0.005 mm); an inner coating of the catheter with a thickness of 30 μm, made of polytetrafluoroethylene. The distal end of the catheter is connected to the proximal neck of the balloon 13, at a distance of 40±0.5 mm there is a radiopaque marker 18, to which a tension wire 10 is attached using a soldering method.

The third part of the delivery system is a proximal catheter with a hardness of 72D (Shore) 3 in contact with blood (Fig. 1), which in turn is structurally identical to catheter 2, also consisting of: an outer, transparent hydrophobic coating (brand "Vestamid ML Care 21"), an outer layer (brand "Pebax 6333"), a stainless steel braid (brand "AISI 304L") and an inner coating of polytetrafluoroethylene (brand "PTFE").

The fourth part of the delivery system is (Fig. 1) the distal sleeve of the handle 4, which does not come into contact with blood, made of neoprene, ensuring the tightness of the handle of the delivery system 5, protecting its internal components from the external environment.

The fifth part of the delivery system is the control mechanism - handle 5 which does not contact with blood (Fig. 4). The handle of the delivery system 5 is equipped with: a front cover 19 (ABS plastic material) designed to protect the internal parts of the handle; a rotary wheel 20 (ABS plastic material) designed to bend the distal end of the delivery system; a handle body 21 (ABS plastic material) designed to protect the internal parts of the handle; a rear cover 22 (ABS plastic material), also designed to protect the internal parts of the handle; a protective panel 23 optically transparent (polycarbonate material) designed to protect the internal parts of the handle and to monitor the position of an indicator 24 (ABS plastic material), which is responsible for the position of the distal end of the delivery system; the indicator 24 moves along a threaded sleeve 25 with external and internal threads (ABS plastic material); along the internal thread of the sleeve 25, the threaded sleeve 26 (polyoxymethylene material) moves, inside the holes of which the tension wire 10 is initially fixed; the stopper 27 (ABS plastic material), as well as the threaded sleeve 26, are mounted on the guide rod 28 (ABS plastic material), which in turn is equipped with a groove for the tension wire 10 and a thread on the proximal and distal side, for screwing into the front 19 and rear 22 covers. Bending the distal end of the delivery system is achieved by rotating the wheel 20 clockwise around its axis, while the indicator 24 moves downwards in the direction of the Luer connector 9. The bending angle can be determined visually using the bending position indicator 24 mounted on the body of the handle 21.

The sixth part of the delivery system is (Fig. 1) the proximal sleeve of the handle 6 made of neoprene, which does not come into contact with blood, but in turn, just like the sleeve 4, ensures the tightness of the handle of the delivery system 5, protecting its internal components from the external environment.

The seventh part of the delivery system is a proximal catheter with a hardness of 35D (according to Shore) 7 that does not contact with blood (Fig. 1), which in turn consists of: an outer, transparent hydrophobic coating (brand "Vestamid ML Care 21"), an outer layer (brand "Pebax 6333") and an inner Teflon coating. I

The eighth part of the delivery system is the connector sleeve 8, which does not come into contact with blood (Fig. 1), which in itself is made of polyether block amide (brand “Pebax”), and is designed to seal the “Luer” connector 9.

The ninth part of the delivery system is a connector with a Luer type connector 9, which does not come into contact with blood (Fig. 1), is made of polycarbonate, is optically transparent, and is visible to ultraviolet radiation during gluing. The Luer connector ensures the passage of the conductor and is connected to the device for inflating and deflating the balloon of the delivery system 13.

The claimed transfemoral delivery system of the balloon-expandable transcatheter aortic heart valve prosthesis is manufactured by sequentially combining, assembling components 1-9 using the heat-shrinkable connection method using fluorinated ethylene propylene heat-shrinkable tubing, as well as the method of gluing with ultraviolet curing using known technologies into a single structure. It is important to note that the adhesive must have the appropriate ISO 10993 certificates to ensure biocompatibility. The adhesive and materials must also be tested after sterilization and aging to ensure their reliable operation.

The following example of the assembly sequence of a transfemoral delivery system for a balloon-expandable transcatheter aortic heart valve prosthesis is presented:

a) All components of the transfemoral delivery system are prepared for assembly. The dimensions and conformity of the components indicated in the drawings are checked.

b) Initially, the assembly of cylinder 1 is carried out in the following sequence. The soft distal tip 12 is installed and fixed with glue at one end of the inner tube 11. For more reliable fixation of the tip 12, the support tube 14 is installed with tension on the inner tube 11. Next, the balloon tube 17 is installed and fixed with epoxy resin on the inner tube 11, at a distance of 5 mm from the support tube 14. At a distance of 10 mm from the free edge of the balloon tube 17, the first radiopaque marker 15 is installed on its surface and fixed with glue, then, at a distance of 15 mm from the first radiopaque marker, the second radiopaque marker 15 is installed, accordingly, with the same step of 15 mm, the third radiopaque marker 15 is installed. Next, two valve stoppers 16 are installed with tension on the balloon tube 17 above the first and third radiopaque markers. At a distance of 5 mm from the proximal edge of the distal tip 12, on its the surface is installed and fixed by heat shrink connection using fluorinated ethylene propylene distal neck of the balloon 13.

c) Before connecting the proximal neck of balloon 13 to catheter 2 using the heat-shrink connection method, the following must be done. Initially, tension wire 10 must be installed and fixed to the fourth radiopaque marker 18 using the soldering method. Next, the reliability and strength of the soldering of tension wire 10 to radiopaque marker 18 must be checked. Then, the fourth radiopaque marker 18, onto which tension wire 10 is pre-soldered, must be installed inside catheter 2 at a distance of 40±0.5 mm from the proximal edge of balloon neck 13. Next, fix radiopaque marker 18 using epoxy resin. Finally, visually check the assembly of balloon 1, including the quality of the connection with catheter 2 for its correctness and tightness of all connections.

d) Catheter 2 is connected to proximal catheter 3 using the heat shrink connection method, as follows. First, make sure that both catheters 2 and 3 have a clean and dry surface in the connection area. Next, cut the heat shrink tubing to the required length so that it is possible to completely cover the connection area with a small margin at each end. Then align the catheters so that the outer diameters match. Next, put the heat shrink tubing on catheter 3 and position it so that it can cover the entire seam when connecting to the other catheter 2. Using a heat source, such as a heat shrink hair dryer, heat the tube evenly, while the heating temperature should correspond to the shrinkage characteristics. After shrinking the tube to a diameter of 4.67 mm (14 Fr, French), wait until the connection cools naturally to room temperature. Next, you need to check the quality of the connection and remove any excess shrink tube, if any.

d) Install the distal coupling 4 onto the proximal catheter 3 with tension.

e) It is important to note that the pre-assembled handle 5 cannot be installed on the catheter 3, due to the presence of an internal tensioning mechanism. In connection with this circumstance, the installation of the components of the handle 5 on the catheter 3 occurs sequentially, as follows.

Initially, at a distance of 20-25 mm from the already installed distal coupling 4 on the catheter 3, a hole with a diameter of 1.5 mm and a depth of 2 mm is made. Through the resulting hole on the catheter 3, it is necessary to remove the tension wire 10, previously fixed on the radiopaque marker 18, passing inside the catheters 2, 3. After the tension wire 10 is outside the catheter 3, it must be stripped of the braid, leaving one wire.

Next, an important step is to connect catheter 3 to catheter 7 using the heat shrink connection method described in detail in paragraph (d).

Then, it is necessary to install the front cover 19 with internal thread on the catheter 3 and align it with the coupling 4. Then, install the guide rod 28 on the catheter 3 and screw it into the front cover 19, which in turn is equipped with a groove for the tension wire 10.

The tension wire 10 must be passed through the groove of the rod 28, in turn, this provides direction for the wire, helping it to stay in place and avoiding accidental bends or kinks.

Next, it is necessary to install the swivel wheel 20 on the rod 28 and align it with the front cover 19.

Then, install the threaded sleeve 26 on the rod 28. Three small holes are provided on the threaded sleeve 26: a small, central hole with a diameter of 1 mm, and two symmetrical, oval holes with a radius of 0.75 mm. Through the oval holes of the sleeve 26, the tension wire 10 is wound in three layers, creating a tight and safe connection. Each layer of wire 10 is carefully laid to eliminate the possibility of slipping or weakening the tension. At the end point, wire 10 is tied in a knot in the small central hole of the threaded sleeve 26, which guarantees its stability and prevents the winding from unwinding during operation of the delivery system.

After fixing the tension wire 10 on the sleeve 26, it is necessary to install the stopper 27 on the rod 28. Then the threaded sleeve 25 with external and internal threads is installed on the rod 28, it is along its internal thread that the sleeve 26 moves.

An indicator 24 is installed on the outer diameter of the threaded sleeve 25. Next, the handle body 21 is screwed into the front cover 19. Then, the protective panel 23 is glued into the body.

At the end of the assembly of the handle, the back cover 22 is screwed into the proximal end of the rod 28, aligning with the body 21.

g) Install the proximal coupling 6 onto the proximal catheter 7 with tension.

c) Install the connector sleeve 8 on the proximal catheter 7 and secure it with ultraviolet-curing glue.

i) Install the Luer connector 9 on the proximal catheter 7 and secure it with ultraviolet-curing glue.

The transfemoral delivery system of the balloon-expandable transcatheter aortic heart valve prosthesis can be made in various sizes, based on the typical dimensions of the aortic valve, with external diameters from 21 to 32 mm. All sizes of the delivery system contain the same set of elements that differ only in geometric characteristics - in particular, the diameter of the balloon 13 and its working length.

Example of use

During the preoperative phase, a complete medical examination of the patient is performed, including imaging studies such as echocardiography, CT scan, or MRI to evaluate the anatomy of the heart and determine the exact size of the heart valve prosthesis needed. The operating room and necessary equipment are prepared, including transfemoral balloon-expandable transcatheter aortic heart valve prosthesis delivery system and the heart valve prosthesis along with related accessories such as 0.89 mm (0.035 inch) diameter introducer sheath, stiff/extra-stiff/ultra-stiff guidewire of appropriate length, crimping instrument, balloon dilation device, 500 ml bowls (sterile) for irrigation, 2 liters of saline solution (sterile), heparinized saline solution (sterile), contrast medium diluted with saline (25% contrast medium), aseptic area for device preparation, 10-30 ml luer lock syringe, 50-60 ml luer lock syringe, 3-way high pressure stopcock, temporary pacemaker with accessories. Equipment for transesophageal echocardiography or transthoracic echocardiography is also required. The transcatheter aortic valve replacement procedure itself is performed under active fluoroscopic direction control. An interventional cardiac surgeon and/or his assistant perform preparatory procedures to ensure transfemoral access to the aortic valve using an introducer (not included in this utility model). The heart valve prosthesis (not included in this utility model) is preliminarily radially compressed to form an outer diameter of no more than 6 mm using a crimping device (not included in this utility model) on a transfemoral delivery system. The compressed heart valve prosthesis on the delivery system is inserted into the femoral artery, advanced to the aorta and placed through the native aorta valve. The delivery system balloon with the heart valve prosthesis attached to it quickly inflates and deflates, expanding and releasing the valve. Cardiac surgeons evaluate the implanted prosthesis for paraprosthetic regurgitation and hemodynamic characteristics using transesophageal echocardiography, evaluate the distribution of contrast and the quality of prosthesis deployment using coronary angiography. After successful implantation, the balloon of the delivery system is deflated and carefully removed from the patient's vascular system, the intervention is completed using known techniques: all auxiliary components are removed; access sites are sutured; the necessary drug support and monitoring are provided; the patient is transferred to the intensive care unit for observation and control of vital signs.

List of references cited

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Claims (1)

A device for transfemoral delivery through the femoral artery and release of a balloon-expandable transcatheter aortic heart valve prosthesis, comprising a balloon assembly, distal and proximal catheters, a handle, a distal and proximal handle coupling, a connector with a Luer connector and a connector coupling, characterized in that the handle comprises front and rear cone-shaped covers, a housing, a rotary wheel for bending the distal end of the delivery system, an optically transparent protective panel for observing the position indicator of the distal end of the delivery system, a stopper for preventing displacement of the threaded sleeve and a bending indicator, wherein the tension wire passing through the catheters is fixed inside the hole of the threaded sleeve, the stopper and the threaded sleeve are mounted on a guide rod equipped with a groove for the tension wire and a thread on the proximal and distal side for screwing into the front and rear covers of the handle, and the bending indicator located on the body.