WO2021016750A1

WO2021016750A1 - Transcatheter aortic prosthetic valve, delivery system, and delivery method

Info

Publication number: WO2021016750A1
Application number: PCT/CN2019/097959
Authority: WO
Inventors: 闫朝武
Original assignee: 闫朝武
Priority date: 2019-07-26
Filing date: 2019-07-26
Publication date: 2021-02-04

Abstract

A transcatheter aortic prosthetic valve, a delivery system, and a delivery method. The prosthetic valve comprises a latticed stent (1) capable of being radially compressed and expanded and prosthetic valve leaflets (2) mounted on the inner side of the stent (1), the stent (1) is provided with an inflow end (4) and an outflow end (5), a plurality of fixing portions (6) expanded outwards and bent downwards to form semicircular barbs are provided at the outflow end (5) of the stent (1), one end of each fixing portion (6) is connected to the stent (1), and the other end thereof faces the direction of a free end of the inflow end (4). The delivery system comprises a delivery tube sheath (9) and an accommodating tube sheath (10), the accommodating tube sheath (10) is used for accommodating the stent (1) in a contraction state, and the fixing portions (6) and adjusting portions (7) are positioned in the delivery tube sheath (9). The delivery method comprises: in a process of replacing aortic heart valves, the fixing portions (6) are firstly released to enter aortic sinuses (11), then the stent (1) is released to enter an in-situ aortic valve (12) area, and the fixing portions (6), the adjusting portions (7), and the expanded stent (1) are interacted to clamp the in-situ aortic valves (12). The positioning precision and accuracy of the aortic prosthetic valve can be improved, and the success rate of valve replacement is improved.

Description

Transcatheter aortic artificial valve, delivery system and delivery method

Technical field

The invention relates to the technical field of artificial valves, in particular to a transcatheter aortic artificial valve, a delivery system and a delivery method.

Background technique

Cardiac aortic stenosis or regurgitation is a common clinical cardiovascular disease, and its incidence is increasing with the aging of the population. Among them, the incidence of aortic valve stenosis in people over 65 years old is 2%-7%. The incidence of aortic insufficiency varies with race. The incidence is about 4.9-10%, and it increases significantly with age. For these patients, artificial valve replacement is required clinically to replace their own diseased valves. Traditional cardiac surgery aortic valve replacement (Surgical Aortic Valve Replacement, SAVR) requires surgical thoracotomy and is performed with the aid of general anesthesia and cardiopulmonary bypass. In view of the highly traumatic nature of SAVR surgery, its application in patients with aortic valve disease of the elderly, complicated comorbidities, surgical contraindications, or high risk of aortic valve disease is limited. In recent years, with the development of Transcatheter Aortic Valve Replacement (TAVR), minimally invasive interventional treatment of aortic valve disease has achieved good results and greatly reduced the patient's surgical risk. After more than ten years of development of TAVR, more than 400,000 patients in Europe and the United States have been treated with this technology.

With the maturity of TAVR technology, various types and mechanisms of transcatheter prosthetic valve systems have emerged. Representative prosthetic valve systems include Edward's Sapien series, Medtronic's CoreValve series, and Poco's Lotus. Series and ACURATE series; and (China) Hangzhou Qiming's VENUS series and Suzhou Jiecheng's J-VALVE series, etc. Various types of valves currently in clinical use have their own advantages and disadvantages, but there are still shortcomings in many aspects such as accurate positioning, position adjustment, prevention of displacement, and taking into account stenosis and insufficiency. Among them, the accurate positioning of artificial valves is a major obstacle to clinical application. The current prosthetic valve release is almost always carried out in the order from the left ventricular outflow tract to the ascending aorta, which makes the positioning of the valve stent difficult. Clinically, the operation mainly depends on the experience of the surgeon. Therefore, the position of the valve stent is often poor. In addition, clinically, aortic valve stenosis is often associated with insufficiency. At present, most artificial valves are designed for stenotic lesions and cannot be applied to patients with insufficiency; a few artificial valves designed for insufficiency are difficult to apply to stenotic lesions. There is also an urgent need for a new type of valve system that can take care of aortic valve stenosis and insufficiency.

Therefore, a new transcatheter aortic artificial valve, delivery system and delivery method are urgently needed to solve the above problems.

Summary of the invention

In order to solve the above-mentioned problems in the existing transcatheter aortic valve replacement surgery, that is, to solve the technical problems of accurate positioning and position adjustment of artificial valve implantation, preventing valve displacement and taking into account stenosis and insufficiency. In a first aspect of the present invention, a transcatheter aortic prosthetic valve is provided, which includes a stent that is in a grid shape and can be compressed and expanded radially and an artificial valve leaflet installed inside the stent, the stent has an inflow end And an outflow end. The outflow end of the stent is provided with a plurality of fixing parts that are flared outward and bent downward to form a semi-annular barb. One end of the fixing part is connected to the stent, and the other end faces the inflow The free end direction of the end.

In some embodiments, a plurality of adjusting parts are further provided at the outflow end of the stent, one end of the adjusting part is connected to the stent, and the other end is flared outward and bent downward to point to the outside of the stent in a barb shape. The wall, or splay outwards and upwards.

In some embodiments, the fixing part and the adjusting part are arranged at equal intervals.

In some embodiments, the number of the fixing part and the adjusting part is equal, the fixing part and the bracket form a closed first mesh hole, and the adjusting part and the bracket form a closed second mesh hole , The second grid hole is located in the first grid hole.

In some embodiments, a connecting piece is provided on the adjusting part for connecting the adjusting cable of the conveying system.

In some embodiments, the connecting member is a threaded hole that can be screwed with the adjustment cable; or the connecting member is a locking head that can be locked with a locking groove on the adjustment cable; Or the connecting member is a locking groove, which can be locked with the locking head on the adjustment cable.

In some embodiments, the outflow end is provided with 12 diamond-shaped grids transversely, thereby forming 12 vertices, and every 4 consecutive vertices form a connecting area, and the two outermost ones in each connecting area The vertices are respectively connected to the same fixing part, and the two innermost vertices in each of the connecting regions are respectively connected to the same adjusting part.

In some embodiments, the stent is laser-cut or knitted based on shape memory alloy and/or superelastic alloy materials.

In a second aspect of the present invention, there is also provided a delivery system for replacement of a subject's aortic valve. The system includes a delivery tube sheath insertable into the subject's aorta, and The receiving tube sheath at the distal end of the delivery tube sheath and the transcatheter aortic artificial valve as described above;

Wherein, the transcatheter aortic prosthetic valve is in a compressed state, the fixing part and the adjusting part of the transcatheter aortic prosthetic valve are placed in the sheath at the distal end of the delivery tube sheath, and the transcatheter aorta The remaining part of the artificial valve is placed in the containing tube sheath.

The third aspect of the present invention also provides a delivery method for the replacement of a subject's aortic valve, the delivery method comprising:

Provide the delivery system as above;

Based on the delivery tube sheath passing through the peripheral artery of the subject, delivering the receiving tube sheath below the aortic valve annulus to enter the left ventricular outflow tract;

Fixing the receiving tube sheath and withdrawing the delivery sheath, releasing the fixing part and the adjusting part, so that the fixing part expands outward and forms a semi-circular barb into the aortic sinus;

Fix the delivery sheath and the adjustment cable, move the receiving sheath forward and release the stent, so that the stent is deployed and fixed in the aortic valve area in situ;

The adjustment part is further released, and the adjustment part is expanded to form a barb pointing to the outer side wall of the valve stent to further clamp and fix the in-situ aortic valve.

The transcatheter aortic prosthetic valve, delivery system and delivery method provided by the present invention have at least the following

Benefits:

The outflow end of the prosthetic valve stent is provided with a plurality of fixed parts that expand outward and form semi-annular barbs, thereby positioning the fixed parts in the aortic sinus, realizing the precise positioning and release of the artificial valve, and improving the transcatheter heart The safety of aortic valve replacement.

Further, a plurality of adjustment parts are provided at the outflow end of the stent. Based on the adjustment part, the valve stent can be fine-tuned to further improve the accuracy of positioning. After the adjustment part is completely released, it expands outwards and bends downward in a barb shape. Point to the outer wall of the valve stent to clamp the in-situ aortic valve to prevent the artificial valve from shifting.

Further, in the delivery method provided by the present invention, before releasing the stent, the positioning part of the outflow end is released, so as to be fixed and accurately positioned in the aortic sinus; after the positioning is accurate, the delivery tube sheath and the adjustment cable are fixed and forwarded. The accommodating tube sheath is moved to accurately release the stent, so that the stent expands and clamps the in-situ aortic valve together with the fixing part and the adjusting part to further stabilize the valve stent. The above-mentioned steps based on the present invention can greatly reduce the complexity of transcatheter heart aortic valve replacement, and improve the success rate of transcatheter heart aortic valve replacement.

Description of the drawings

Fig. 1 is a schematic diagram of a three-dimensional structure of a transcatheter aortic prosthetic valve in an embodiment of the present invention;

Figure 2 is a schematic top view of a transcatheter aortic prosthetic valve in an embodiment of the present invention;

3 is a schematic diagram of the main structure of a transcatheter aortic prosthetic valve adjustment cable before release in an embodiment of the present invention;

Figure 4 is a schematic view of a transcatheter aortic prosthetic valve stent in a flat state in an embodiment of the present invention;

5 is a schematic diagram of the main structure of a transcatheter aortic prosthetic valve delivery system in an embodiment of the present invention;

Fig. 6 is a schematic diagram of a use state of a transcatheter aortic prosthetic valve delivery system releasing a stent fixing part in an embodiment of the present invention;

Fig. 7 is a schematic diagram of a use state of a transcatheter aortic prosthetic valve delivery system releasing a valve stent in an embodiment of the present invention;

Fig. 8 is a schematic diagram of a state of use of the transcatheter aortic prosthetic valve delivery system in an embodiment of the present invention in which the adjustment part and the adjustment cable are released and the prosthetic valve is completely released;

Figure 9 is one of the schematic flow diagrams of a transcatheter aortic prosthetic valve delivery method in an embodiment of the present invention;

Fig. 10 is a second schematic flow chart of a transcatheter aortic prosthetic valve delivery method in an embodiment of the present invention;

Figure 11 is a third schematic flow chart of a transcatheter aortic prosthetic valve delivery method in an embodiment of the present invention;

Fig. 12 is the fourth flow diagram of a transcatheter aortic prosthetic valve delivery method in an embodiment of the present invention.

Detailed ways

Hereinafter, preferred embodiments of the present invention will be described with reference to the drawings. Those skilled in the art should understand that these embodiments are only used to explain the technical principles of the present invention and are not intended to limit the protection scope of the present invention.

Referring to Figures 1 to 3, Figures 1 to 3 exemplarily show the main structure of the transcatheter aortic prosthetic valve. As shown in the figure, the transcatheter aortic prosthetic valve includes a mesh-like and radially compressible and The expanded stent 1 and the artificial valve leaflets 2 and the petticoat 3 installed inside the stent 1. The stent 1 can be laser cut or knitted based on shape memory alloy and/or superelastic alloy materials. The artificial valve leaflet 2 is installed at the waist position inside the stent 1 and can be opened and closed unidirectionally to form a blood channel for blood to enter the aorta from the left ventricle. The artificial valve leaflet 2 can be two, three or more. The material of the artificial valve leaflet 2 can be animal pericardium, such as bovine pericardium, porcine pericardium, etc., or polymer material, such as polytetrafluoroethylene, fiber cloth or fiber membrane, etc., or medical metal, pyrolytic carbon, etc., The artificial valve leaflet 2 is also an alternative material for other heart valves. The petticoat 3 installed on the inner side of the stent 2 to increase the airtight performance. The petticoat 3 can be made of animal pericardium, such as bovine pericardium, pig pericardium, etc., or polymer materials, such as polytetrafluoroethylene, fiber cloth or fiber membrane Wait. In some embodiments, the artificial valve may not include a petticoat. The materials and installation of the aforementioned artificial valve leaflets 2 and petticoat 3 are all existing technologies, and will not be repeated here. The main features of the transcatheter aortic artificial valve provided by the present invention are:

The stent has an inflow end 4 and an outflow end 5. The outflow end 5 of the stent 1 is provided with a plurality of fixing parts 6 that are flared outward and bent downward to form semi-annular barbs. One end of the fixing part 6 is connected to the stent 1, and the other end Towards the free end direction of the inflow end 4. Specifically, when the fixed portion 6 is spread out on a two-dimensional plane, the shape of the fixed portion 6 includes, but is not limited to, a semi-circular shape, a triangular shape, a longitudinal shape, a semi-elliptical shape, and an arch shape. When the stent 1 is in an expanded three-dimensional state, the fixing portion 6 is a structure that expands outward and bends downward to form a semi-annular barb (as shown in FIG. 3). When the fixing portion 6 is in the opened state (or released state), the height can be 2 mm to 30 mm, and the width can be 2 mm to 30 mm.

In some embodiments, the outflow end 5 of the stent 1 is further provided with a plurality of adjusting parts 7, one end of the adjusting part 7 is connected to the stent 1, and the other end is flared and bent downward to point to the outer side wall of the stent 1 in a barb shape. Or splay outwards and upwards. Specifically, when the adjustment portion 7 is in a three-dimensional state of being fully expanded (ie, completely released, or the adjustment cable has been released), the adjustment portion 7 is expanded outward and bends downward in a barb shape toward the outer side wall ( As shown in Figure 1). When the adjustment part 7 is incompletely opened (that is, incompletely released, or the adjustment cable is not released), the adjustment part 7 expands outward and upward, and the plurality of adjustment parts 7 form a bell mouth shape or a petal shape ( As shown in Figure 3). When the adjustment part 7 is spread out on a two-dimensional plane, its shape includes, but is not limited to, a triangle, a half ring, a square, a rectangle, a semicircle, a semi-ellipse, and an arch shape. When the adjustment part is in an incompletely opened state, its shape The height can be 2mm to 30mm.

The fixing part 6 and the adjusting part 7 are both arranged at equal intervals. Specifically, the fixing part 6 and the adjusting part 7 can be arranged side by side and at equal intervals along the outflow end 5 of the bracket 1, for example, according to the fixing part 6, the adjusting part 7, and the fixing part. The part 6, the adjustment part 7... etc. are repeatedly arranged to surround the outflow end 5 of the stent 1; it can also be the fixed part 6, the adjustment part 7, the adjustment part 7, the fixed part 6, the adjustment part 7, the adjustment part 7, and the fixed part 6. …And so on repeatedly arranged to surround the outflow end 5 of the stent 1; it can also be repeatedly arranged according to the adjusting part 7, the fixing part 6, the fixing part 6, the adjusting part 7, the fixing part 6, the fixing part 6, and so on to surround the stent The outgoing end of 1 is 5; these surround modes can be analogously adjusted according to actual applications. Of course, the fixed part 6 can also be sheathed with an adjusting part 7. For example, one fixed part 6 is sheathed with an adjusting part 7, a fixed part 6 is sheathed with two adjusting parts 7, and a fixed part 6 is sheathed with three adjusting parts. The parts 7 and so on can be deduced by analogy, or one adjusting part 7 is sheathed with a fixed part 7, an adjusting part 7 is sheathed with two fixed parts 6, and an adjusting part 7 is sheathed with three fixed parts 6, etc. analogy.

Referring to FIG. 4, FIG. 4 exemplarily shows the flat state after the bracket is cut, that is, the state in which the bracket 1 is cut and laid on a two-dimensional plane. As shown in FIG. 4, the fixing part 6 and the adjustment The number of the parts 7 is equal, the fixing part 6 and the bracket form a closed first mesh hole, the adjusting part 7 and the bracket form a closed second mesh hole, and the second mesh hole is located in the first mesh hole. More specifically, the outflow end 5 is provided with 12 diamond-shaped grids transversely, thereby forming 12 vertices, and every 4 consecutive vertices form a connecting area, and the two outermost vertices in each connecting area are respectively connected to the same fixed part 6. The two innermost vertices in each connecting area are respectively connected to the same adjusting part 7. Furthermore, three diamond grids are arranged in the longitudinal direction from the inflow end 4 to the outflow end 5, and the diamond grids are connected to each other to form the body structure of the stent 1. In this embodiment, when the bracket 1 is in the open state of the three-dimensional space, the vertical distance from the highest point of the adjusting portion 7 to the vertex of the free end of the fixing portion 6 may be 2 mm to 30 mm.

In some embodiments, a connecting piece (not shown) is provided on the adjusting part 7 for connecting the adjusting cable 8 of the conveying system. The delivery system is the delivery equipment of the artificial valve, and the adjustment cable 8 is a cable that controls the release and position adjustment of the artificial valve in the delivery system. In this embodiment, it is a thin steel cable. More specifically, the connecting piece is a threaded hole, and a thread matching the threaded hole is provided at the end of the adjusting cable 8, and the threaded hole is screwed to the adjusting cable 8; or the connecting piece is a locking head, and the adjusting cable The cable 8 is provided with a locking groove that matches the locking groove, and the locking head is connected to the locking groove based on the locking; or the connector is a locking groove, and the adjustment cable 8 is provided with the locking groove. The lock buckle head matched with the buckle groove is locked and connected with the lock buckle head through the lock buckle groove.

The embodiment of the present invention also provides a delivery system for the replacement of the aortic valve of the heart of a subject. Please refer to FIG. 5, which exemplarily shows the main structure of the delivery system, as shown in FIG. The system includes a delivery tube sheath 9 that can be inserted into the aorta of a subject, a receiving tube sheath 10 provided at the distal end of the delivery tube sheath 9 and the transcatheter aortic prosthetic valve as described above; wherein the transcatheter aortic prosthetic valve is in compression In the state, the fixing part 6 and the adjusting part 7 of the transcatheter aortic prosthetic valve are placed in the sheath at the distal end of the delivery tube sheath 9, and the rest of the transcatheter aortic prosthetic valve is placed in the receiving sheath 10. In addition, each adjustment part 7 is connected by a different adjustment cable 8, and the other end of the adjustment cable 8 extends out of the delivery tube sheath 9, which is convenient for the operator to operate and control each component. It should be noted that the receiving tube sheath 9 and the delivery tube sheath 10 may not be directly connected.

Please refer to FIGS. 5 to 8, which exemplarily show the use process of the conveying system. As shown in the figure, three adjustment parts 7 are connected to the bracket 1, and an adjustment cable 8 is connected to each adjustment part 7. The delivery system is delivered through the peripheral artery, preferably the femoral artery, and the containment sheath 10 is delivered under the aortic valve annulus into the left ventricular outflow tract; by fixing the containment sheath 10, the delivery sheath 9 is withdrawn to release the fixing portion 6 and Adjusting part 7; in the process of opening the fixing part 6, by fine-tuning the adjustment cable 8 corresponding to the adjusting part 7, the fixing part 6 is accurately hooked in the three aortic sinuses 11; after the position adjustment is completed, the fixed delivery The sheath tube 9 and the adjustment cable 8 are moved forward, and the sheath 10 is moved forward to completely release the valve stent into the aortic valve area; after determining the shape and position of the stent 1 of the aortic prosthetic valve is appropriate, untie the adjustment cable 8 on the adjustment part 7 , The adjustment part 7 is completely opened to form a barb shape, which is hooked on the aortic valve 12 in situ. After the stent 1 of the prosthetic valve is fully expanded, the outer side wall of the stent 1 and the fixed part 6 and the adjustment part 7 form a "hairpin" structure to clamp the in-situ aortic valve 12 together to prevent the stent 1 from falling off or shifting.

The embodiment of the present invention also provides a delivery method for replacement of a subject's aortic valve, the delivery method includes:

Step S1: Provide the delivery system as described above;

Step S2: Based on the delivery tube sheath 9 passing through the peripheral artery of the subject, the receiving tube sheath 10 is delivered below the aortic valve annulus to enter the left ventricular outflow tract;

Step S3: Fix the receiving tube sheath 10 and withdraw the delivery sheath 9 back, release the fixed part 6 and the adjusting part 7, so that the fixed part 6 expands outward and forms a semi-circular barb into the aortic sinus 11;

Step S4: Fix the delivery sheath 9 and the adjustment cable 8, move the receiving sheath 10 forward and release the stent 1, so that the stent 1 is deployed and fixed in the aortic valve area in situ;

Step S5: further release the adjusting part 7 so that the adjusting part 7 is expanded to form a barb pointing to the outer side wall of the stent to further clamp and fix the aortic valve 12 in situ.

The delivery method provided by the present invention will be described below with reference to the drawings and a specific embodiment.

Refer to Figures 9 to 12, which exemplarily show the main flow of the delivery method: the delivery system is passed through the peripheral artery, preferably the femoral artery, and the housing sheath 10 is delivered to the left ventricular outflow tract under the aortic valve annulus ; By fixing the inner core 13 of the delivery system and the adjustment cable 8, the delivery tube sheath 9 is withdrawn, and the fixed part 6 and the adjustment part 7 are released; the fixed part 6 is opened and its position is adjusted to make it hook into the aorta accurately Inside the sinus 11; after the position adjustment is completed, by fixing the adjustment cable 8 and the delivery sheath 9, move forward the stent 1 containing the sheath 10 to release the artificial valve; after determining the shape and position of the artificial valve, remove the adjustment part 7 The adjustment cable 8 makes the adjustment part 7 open and hook the in situ aortic valve 12; after the stent 1 and the fixed part 6, the adjustment part 7 are fully expanded, the outer side wall of the stent 1 and the fixed part 6, adjust The portion 7 forms a structure similar to a "hairpin", and together clamps the in situ aortic valve 12 to prevent the stent 1 from falling off or shifting. It should be noted that the inner core is a slender metal tube that runs through the center of the entire delivery system to provide support for the entire system. Other sheath components and valve stents are sleeved outside the inner core; radially from inside to outside. Yes: inner core, valve stent, sheath that contains the valve stent. The inner core metal tube allows a longer stiffened guide wire to pass through. The entire delivery system is fed into the heart by first feeding the stiffened guide wire into the heart, and then the inner core of the delivery system is covered with the stiffened guide wire and sent along. Into the heart.

The transcatheter aortic artificial valve provided by the present invention not only ensures the accurate positioning of the valve stent, but also provides sufficient supporting force and clamping force to prevent the valve stent from shifting.

Further, the fixing part provided at the outflow end of the stent is a semi-annular barb structure, which is hooked on the aortic sinus after being expanded (after being released) to achieve precise positioning and fixing of the artificial valve, and the fixing part and the adjusting part are in After deployment (after release), it is clamped with the outer side wall of the stent to form a similar "hairpin" structure, which together clamp the in-situ aortic valve to fix the valve stent and prevent the stent from shifting.

Further, the position of the stent can be fine-tuned by the adjustment part to prevent the initial release position from being inaccurate, resulting in failure of heart valve replacement and affecting the life of the subject.

Further, the fixing part and the adjusting part are arranged at the outflow end of the artificial valve stent. After the artificial valve stent, the fixing part and the adjusting part are fully expanded, the outer side wall of the stent and the fixing part and the adjusting part form a structure similar to a "hairpin". Clamp the aortic valve in situ to prevent the valve stent from falling off or shifting. Compared with the traditional artificial valve, the fixed part and the adjusting part enter the aortic sinus and clamp the in situ aortic valve together to release the stent It is simpler and more precise, and the position is more stable. Therefore, when the artificial valve is fully expanded, the part of the stent that is higher than the aortic annulus can be designed to be lower, preventing the part higher than the aortic annulus from compressing the coronary The artery opens, causing other complications.

It should be noted that in the description of the present invention, a "subject" is an individual including but not limited to animals (e.g., humans, horses, pigs, rabbits, dogs, sheep, goats, non-human primates, cattle, Cats, guinea pigs or rodents), fish, birds, reptiles or amphibians. The term does not indicate a specific age or gender. Therefore, it also includes adult and newborn subjects and fetuses (whether male or female).

It should be noted that in the description of the present invention, various elements in the embodiments are drawn according to the proportions, sizes, deformations or displacements suitable for explanation, rather than drawn according to the actual element proportions.

It should be noted that in the description of the present invention, the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "front", "rear", etc. The terms indicating the direction or positional relationship are based on the direction or positional relationship shown in the drawings, which is only for ease of description, and does not indicate or imply that the device or element must have a specific orientation, be configured and operated in a specific orientation, Therefore, it cannot be understood as a limitation to the present invention. In addition, the terms "first", "second", and "third" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance.

In addition, it should be noted that, in the description of the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it may be a fixed connection or It is a detachable connection or an integral connection; it can be a mechanical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be a connection between two components. For those skilled in the art, the specific meaning of the above-mentioned terms in the present invention can be understood according to specific circumstances.

The term "including" or any other similar term is intended to cover non-exclusive inclusion, so that a process, method, article or equipment/device including a series of elements includes not only those elements, but also other elements not explicitly listed, or It also includes the inherent elements of these processes, methods, articles or equipment/devices.

So far, the technical solutions of the present invention have been described in conjunction with the preferred embodiments shown in the drawings. However, those skilled in the art will readily understand that the protection scope of the present invention is obviously not limited to these specific embodiments. Without departing from the principle of the present invention, those skilled in the art can make equivalent changes or substitutions to the relevant technical features, and the technical solutions after these changes or substitutions will fall within the protection scope of the present invention.

Claims

A transcatheter aortic artificial valve, comprising a grid-shaped stent that can be compressed and expanded radially and an artificial valve leaflet installed inside the stent. The stent is characterized in that the stent has an inflow end and an outflow end. The outflow end of the stent is provided with a plurality of fixing parts that are flared outward and bent downward to form a semi-annular barb. One end of the fixing part is connected to the stent and the other end faces the free end of the inflow end.
The transcatheter aortic prosthetic valve according to claim 1, wherein a plurality of adjusting parts are further provided at the outflow end of the stent, one end of the adjusting part is connected to the stent, and the other end is opened outwardly. It is bent downward to point to the outer side wall of the bracket in a barb shape, or expands outward and upward.
The transcatheter aortic prosthetic valve according to claim 2, wherein the fixing part and the adjusting part are both arranged at equal intervals.
The transcatheter aortic prosthetic valve according to claim 2, wherein the number of the fixing part and the adjusting part are equal,

The fixing part and the bracket form a closed first mesh hole, the adjustment part and the bracket form a closed second mesh hole, and the second mesh hole is located between the first mesh hole Inside.
The transcatheter aortic prosthetic valve according to claim 2, wherein the adjusting part is provided with a connector for connecting the adjusting cable of the delivery system.
The transcatheter aortic prosthetic valve according to claim 5, wherein the connecting member is a threaded hole that can be screwed with the adjustment cable; or

The connecting piece is a locking head, which can be locked with the locking groove on the adjustment cable; or

The connecting piece is a locking groove, which can be locked with the locking head on the adjustment cable.
The transcatheter aortic prosthetic valve according to claim 2, wherein the outflow end is provided with 12 diamond-shaped grids transversely to form 12 vertices, and each 4 consecutive vertices form a connection area, The two outermost vertices in each connecting area are respectively connected to the same fixing portion, and the two innermost vertices in each connecting area are respectively connected to the same adjusting portion.
The transcatheter aortic prosthetic valve according to any one of claims 1 to 7, wherein the stent is laser cut or knitted based on a shape memory alloy and/or superelastic alloy material.
A delivery system for the replacement of a subject's heart aortic valve, characterized in that the system includes a delivery tube sheath that can be inserted into the subject's aorta, and a delivery tube sheath arranged at the distal end of the delivery tube sheath Containing a sheath and the transcatheter aortic prosthetic valve according to any one of claims 2 to 8;

Wherein, the transcatheter aortic prosthetic valve is in a compressed state, the fixing part and the adjusting part of the transcatheter aortic prosthetic valve are placed in the sheath at the distal end of the delivery tube sheath, and the transcatheter aorta The remaining part of the artificial valve is placed in the containing tube sheath.
A delivery method for replacement of a subject’s aortic valve, characterized in that the delivery method includes:

Provide a delivery system as claimed in claim 9;

Based on the delivery tube sheath passing through the peripheral artery of the subject, delivering the receiving tube sheath below the aortic valve annulus to enter the left ventricular outflow tract;

Fixing the receiving tube sheath and withdrawing the delivery sheath, releasing the fixing part and the adjusting part, so that the fixing part expands outward and forms a semi-circular barb into the aortic sinus;

Fix the delivery sheath and the adjustment cable, move the receiving sheath forward and release the stent, so that the stent is deployed and fixed in the aortic valve area in situ;

The adjustment part is further released, and the adjustment part is expanded to form a barb pointing to the outer side wall of the stent to further clamp and fix the in-situ aortic valve.