CN111329621A - Transcatheter aortic prosthetic valve, delivery system and delivery method - Google Patents

Abstract

The invention discloses a transcatheter aortic artificial valve, a conveying system and a conveying method, wherein the artificial valve comprises a latticed support which can be compressed and expanded in the radial direction and artificial valve leaflets arranged on the inner side of the support, the support is provided with an inflow end and an outflow end, a plurality of fixing parts which are expanded outwards and bent downwards to form semicircular barbs are arranged at the outflow end of the support, one end of each fixing part is connected with the support, and the other end of each fixing part faces to the direction of a free end of the inflow end. The conveying system comprises a conveying pipe sheath and a containing pipe sheath, the containing pipe sheath is used for containing the bracket in the shrinkage state, and the fixing part and the adjusting part are positioned in the conveying pipe sheath. The conveying method comprises the following steps: in the process of replacing the aortic valve of the heart, the fixing part is released firstly to enter the aortic sinus, then the stent is released to enter the in-situ aortic valve area, and the fixing part, the adjusting part and the unfolded stent mutually clamp the in-situ aortic valve. The invention improves the positioning precision and accuracy of the aortic artificial valve and improves the success rate of valve replacement.

Description

Transcatheter aortic prosthetic 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

Aortic valve stenosis or insufficiency of the heart is a common clinical cardiovascular disease, and its incidence is increasing with the aging of the population. The incidence of aortic valve stenosis in people over 65 years old is 2%-7%. The incidence of aortic insufficiency varies with ethnicity, and its incidence is about 4.9-10%, and it increases significantly with age. For these patients, prosthetic valve replacement is clinically required to replace the native diseased valve. Traditional cardiac surgery for aortic valve replacement (Surgical Aortic Valve Replacement, SAVR) requires surgical thoracotomy and is performed under general anesthesia and cardiopulmonary bypass. Given the highly invasive nature of SAVR, its use in patients with aortic valve disease who are elderly, have complex comorbidities, surgical contraindications, or are at high risk 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 curative effect and greatly reduced the surgical risk of patients. 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 different mechanisms of transcatheter prosthetic valve systems have emerged. Representative prosthetic valve systems include: (Europe and America) Edward's Sapien series, Medtronic's CoreValve series, Poco's Lotus series series and ACURATE series; and (China) Hangzhou Qiming's VENUS series and Suzhou Jiecheng's J-VALVE series and so on. At present, various types of valves in clinical application have their own advantages and disadvantages, but there are still shortcomings in many aspects such as accurate positioning, position adjustment, prevention of displacement, and consideration of stenosis and insufficiency of valve implantation. Among them, the accurate positioning of the artificial valve is a major obstacle to clinical application. The current prosthetic valve release is almost always performed sequentially from the left ventricular outflow tract to the ascending aorta, which makes the positioning of the valve stent difficult. In addition, clinical aortic valve stenosis is often combined with insufficiency, and most of the current artificial valves are designed for stenotic lesions and cannot be used in 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 valve system that can take into account both aortic stenosis and regurgitation.

Therefore, there is an urgent need for a new transcatheter aortic prosthetic valve, delivery system and delivery method to solve the above problems.

SUMMARY OF THE INVENTION

In order to solve the above problems in the existing transcatheter aortic valve replacement, that is, to solve the technical problems such as accurate positioning, position adjustment, prevention of valve displacement, and stenosis and insufficiency of artificial valve implantation. A first aspect of the present invention provides a transcatheter aortic prosthetic valve, comprising a grid-shaped stent capable of radially compressing and expanding, and a prosthetic valve leaflet installed inside the stent, the stent having an inflow end and the outflow end, at the outflow end of the bracket, there are a plurality of fixing parts that are opened outward and bent downward to form semi-annular barbs, one end of the fixing part is connected to the bracket, and the other end faces the inflow free end direction of the end.

In some embodiments, a plurality of adjustment parts are further provided at the outflow end of the bracket, one end of the adjustment parts is connected to the bracket, and the other end is opened outward and bent downward in a barb shape pointing to the outside of the bracket wall, or flare out and up.

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

In some embodiments, the number of the fixing portion and the adjusting portion is equal, the fixing portion and the bracket form a closed first mesh hole, and the adjusting portion and the bracket form a closed second mesh hole , the second mesh hole is located inside the first mesh hole.

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

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

In some embodiments, the outflow end is laterally provided with 12 diamond meshes, thereby forming 12 vertices, every 4 consecutive vertices form a connection area, and the outermost two in each connection 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 woven based on shape memory alloy and/or superelastic alloy material.

In a second aspect of the present invention, there is also provided a delivery system for the replacement of aortic valve of a subject's heart, the system comprising a delivery catheter sheath insertable into the aorta of the subject, disposed in the aorta of the subject A receiving sheath at the distal end of the delivery sheath and a transcatheter aortic prosthetic 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 sheath, and the transcatheter aortic valve is in a compressed state. The remainder of the prosthetic valve is placed within the containment sheath.

In a third aspect of the present invention, there is also provided a delivery method for the replacement of a heart aortic valve of a subject, the delivery method comprising:

provide a delivery system as described above;

delivering the containment sheath below the aortic annulus to enter the left ventricular outflow tract based on the passage of the delivery sheath through the peripheral artery of the subject;

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

Fixing the delivery sheath and adjusting the cable, moving the accommodating sheath forward and releasing the stent, so that the stent is deployed and fixed in the in-situ aortic valve area;

The adjusting portion is further released, so that the adjusting portion 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 at least have the following beneficial effects:

The outflow end of the prosthetic valve stent is provided with a plurality of fixing parts that open outward and form semi-annular barbs, so as to locate the fixing parts in the aortic sinus, realize the precise positioning and release of the artificial valve, and improve the transcatheter heart rate. Safety of aortic valve replacement surgery.

Further, a plurality of adjustment parts are arranged at the outflow end of the stent, and the valve stent can be fine-tuned based on the adjustment parts, which further improves the positioning accuracy. Point to the lateral wall of the valve stent to hold the in situ aortic valve and prevent the prosthetic valve from shifting.

Further, in the delivery method provided by the present invention, before releasing the stent, first release the positioning part of the outflow end, so as to fix and accurately position it in the aortic sinus; The accommodating tube sheath is moved to release the stent accurately, so that the stent is expanded and the in-situ aortic valve is clamped together with the fixing part and the adjusting part to further stabilize the valve stent. Based on the above steps of the present invention, the complexity of transcatheter aortic valve replacement can be greatly reduced, and the success rate of transcatheter aortic valve replacement can be improved.

Description of drawings

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

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 before the release of a transcatheter aortic prosthetic valve adjustment cable according to an embodiment of the present invention;

Fig. 4 is a kind of transcatheter aortic prosthetic valve stent in the embodiment of the present invention cut open and laying state schematic diagram;

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

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

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

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

9 is one of the schematic flow charts of a method for delivering a transcatheter aortic prosthetic valve according to an embodiment of the present invention;

10 is the second schematic flow chart of a method for delivering a transcatheter aortic prosthetic valve according to an embodiment of the present invention;

11 is a third schematic flow chart of a method for delivering a transcatheter aortic prosthetic valve according to an embodiment of the present invention;

12 is a fourth schematic flowchart of a method for delivering a transcatheter aortic prosthetic valve according to an embodiment of the present invention.

Detailed ways

Preferred embodiments of the present invention are described below with reference to the accompanying drawings. It should be understood by those skilled in the art that these embodiments are only used to explain the technical principle 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, the transcatheter aortic prosthetic valve includes a grid-like and radially compressible and The deployed stent 1 and the artificial valve leaflets 2 and the petticoat 3 installed inside the stent 1, the stent 1 may be laser-cut or woven based on shape memory alloy and/or superelastic alloy material. 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 number of artificial valve leaflets 2 can be two, three or more. The material of the artificial valve leaflet 2 can be animal pericardium, such as bovine pericardium, pig pericardium, etc., or polymer material, such as polytetrafluoroethylene, fiber cloth or fiber membrane, etc., or medical metal, pyrolytic carbon, etc., The prosthetic leaflet 2 is also an alternative material for other heart valves. The petticoat 3 installed on the inner side of the bracket 2 is used to increase the sealing 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 prosthetic valve may not contain a petticoat. The material and the installation of the aforementioned artificial valve leaflet 2 and the petticoat 3 are the prior art, and will not repeat them here. The main features of the transcatheter aortic artificial valve provided by the present invention are:

The bracket has an inflow end 4 and an outflow end 5. The outflow end 5 of the bracket 1 is provided with a plurality of fixing portions 6 that are opened outward and bent downward to form semi-annular barbs. One end of the fixing portion 6 is connected to the bracket 1, and the other end is towards the free end of the inflow end 4 . Specifically, when the fixing portion 6 is flattened on a two-dimensional plane, the shape of the fixing portion 6 includes, but is not limited to, semi-circular, triangular, elongated, semi-elliptical, and arch-shaped. When the stent 1 is in the unfolded three-dimensional state, the fixing portion 6 is a structure in which the fixing portion 6 is opened outward and bent downward to form a semi-annular barb (as shown in FIG. 3 ). When the fixing portion 6 is in an open state (or a released state), its height may be 2 mm to 30 mm, and its width may be 2 mm to 30 mm.

In some embodiments, the outflow end 5 of the bracket 1 is further provided with a plurality of adjustment parts 7, one end of the adjustment parts 7 is connected to the bracket 1, and the other end of the adjustment part 7 is opened outward and bent downward in a barb shape pointing to the outer wall of the bracket 1, Or flare out and up. Specifically, when the adjustment part 7 is in a three-dimensional state of being fully opened (ie, fully released, or the adjustment cable has been released), the adjustment part 7 is opened outward and bent downward in the shape of a barb, pointing to the outer wall of the bracket 1 ( As shown in Figure 1). When the adjustment part 7 is not fully opened (ie, not fully released, or the adjustment cable is not released), the adjustment part 7 opens 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 flattened on a two-dimensional plane, its shape includes but is not limited to a triangle, a semi-circle, a square, a rectangle, a semi-circle, a semi-ellipse, and an arch shape. The height can be from 2mm to 30mm.

The fixing parts 6 and the adjusting parts 7 are arranged at equal intervals. Specifically, the fixing parts 6 and the adjusting parts 7 can be arranged side by side and at equal intervals along the outflow end 5 of the bracket 1. The parts 6, the adjustment parts 7, etc. are repeatedly arranged to surround the outflow end 5 of the bracket 1; ... etc. are repeatedly arranged to surround the outflow end 5 of the bracket 1; it can also be arranged repeatedly according to the adjustment part 7, the fixed part 6, the fixed part 6, the adjustment part 7, the fixed part 6, the fixed part 6, ..., etc., to surround the bracket 1 outflow end 5; these wraparounds can be adjusted analogously according to the actual application. Of course, the fixing part 6 can also be sleeved with the adjustment part 7. For example, one adjustment part 7 is sleeved in one fixing part 6, two adjustment parts 7 are sleeved in one fixing part 6, and three adjustment parts are sleeved in one fixing part 6. Part 7 and so on and so on, or one fixing part 7 is sleeved in one adjusting part 7, two fixing parts 6 are sleeved in one adjusting part 7, three fixing parts 6 are sleeved in one adjusting part 7, etc. analogy.

Referring to FIG. 4, FIG. 4 exemplarily shows the tiled state after the bracket is cut, that is, the state in which the bracket 1 is sectioned and tiled on a two-dimensional plane. As shown in FIG. 4, the fixing part 6 and the adjustment The number of 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 laterally provided with 12 diamond meshes, thereby forming 12 vertices, and every 4 consecutive vertices form a connection area, and the two outermost vertices in each connection area are respectively connected to the same fixed part. 6. The two innermost vertices in each connection area are respectively connected to the same adjustment part 7 . Furthermore, three rhombus meshes are arranged in the longitudinal direction from the inflow end 4 to the outflow end 5 , and the rhombus meshes 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 adjustment part 7 to the vertex of the free end of the fixing part 6 may be 2 mm to 30 mm.

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

An embodiment of the present invention also provides a delivery system for the replacement of 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. 5 , the delivery The system includes a delivery sheath 9 insertable inside a subject's aorta, a containment sheath 10 disposed at the distal end of the delivery sheath 9, and a 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 sheath 9 , and the rest of the transcatheter aortic prosthetic valve is placed in the accommodating 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 accommodating sheath 9 and the delivery sheath 10 may not be directly connected.

Please refer to FIG. 5 to FIG. 8 , which exemplarily show the use process of the delivery system. As shown in the figures, three adjustment parts 7 are connected to the bracket 1 , and each adjustment part 7 is connected to an adjustment cable 8 . The delivery system is passed through the peripheral artery, preferably the femoral artery, and the accommodating tube sheath 10 is transported under the aortic valve annulus into the left ventricular outflow tract; by fixing the accommodating tube sheath 10, the delivery tube sheath 9 is withdrawn to release the fixing portion 6 and Adjustment part 7; in the process of opening the fixed part 6, by fine-tuning the adjustment cable 8 corresponding to the adjustment part 7, the fixed 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 to fully release the valve stent into the aortic valve area; after confirming that the shape and position of the stent 1 of the aortic prosthetic valve are appropriate, untie the adjustment cable 8 on the adjustment part 7 , after the adjustment part 7 is fully opened, it forms a barb shape and is hooked on the aortic valve 12 in situ. After the stent 1 of the artificial valve is fully opened, the outer wall of the stent 1, the fixing part 6 and the adjusting part 7 form a similar "hairpin" structure, which together clamp the in-situ aortic valve 12 to prevent the stent 1 from falling off or shifting.

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

Step S1: provide the above-mentioned conveying system;

Step S2: based on the delivery tube sheath 9 passing through the peripheral artery of the subject, the accommodating tube sheath 10 is delivered below the aortic valve annulus, thereby entering the left ventricular outflow tract;

Step S3: fixing the accommodating sheath 10 and withdrawing the delivery sheath 9, releasing the fixing portion 6 and the adjusting portion 7, so that the fixing portion 6 opens 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 accommodating sheath 10 forward and release the stent 1, so that the stent 1 is unfolded and fixed in the in-situ aortic valve area;

Step S5 : further release the adjustment part 7 , so that the adjustment part 7 is opened 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 conveying method provided by the present invention will be described below with reference to the accompanying drawings and a specific embodiment.

Referring to Figures 9 to 12, the main flow of the delivery method is exemplarily shown: after the delivery system is passed through the peripheral artery, preferably the femoral artery, and the receiving 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 adjusting the cable 8, the delivery tube sheath 9 is withdrawn, and the fixing part 6 and the adjusting part 7 are released; The fixing part 6 is opened and its position is adjusted to accurately hook it into the aorta 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 that accommodates the sheath 10 to release the artificial valve; after confirming that the shape and position of the artificial valve are appropriate, remove the upper part of the adjustment part 7 Adjust the cable 8, so that the adjustment part 7 is opened and hooked on the in-situ aortic valve 12; The parts 7 form a structure similar to a "hairpin", which together hold 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, providing support for the entire system, and other sheath components and valve stents are sleeved outside the inner core; radially from the inside to the outside in order Yes: inner core, valve stent, sheath for accommodating valve stent. A long hardened guide wire can be passed through the middle of the inner core metal tube. When the entire delivery system is sent to the heart, the hardened guide wire is first sent into the heart, and then the inner core of the delivery system is covered with the hardened 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 being displaced.

Further, the fixing part arranged on the outflow end of the stent is a semi-annular barb structure, and after it is opened (after releasing), it is hooked on the aortic sinus part to realize the precise positioning and fixing of the artificial valve, and the fixing part and the adjusting part are located in the aortic sinus part. After deployment (after release), it is clamped with the outer side wall of the stent to form a similar "hairpin" structure, which jointly clamps 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, so as to prevent the inaccuracy of the initial release position, causing the heart valve replacement failure and affecting the life of the subject.

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

It should be noted that, in the description of the present invention, "subject" is an individual including but not limited to animals (eg, humans, horses, pigs, rabbits, dogs, sheep, goats, non-human primates, cattle, cat, guinea pig or rodent), fish, bird, reptile or amphibian. The terms do not denote a specific age or gender. Thus, it also includes adult and neonatal subjects as well as 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 proportion, size, deformation or displacement suitable for the description, rather than the scale of the actual element.

It should be noted that in the description of the present invention, the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "front", "rear", etc. Terms indicating a direction or positional relationship are based on the direction or positional relationship shown in the drawings, which are only for convenience of description, and do not indicate or imply that the device or element must have a particular orientation, be constructed and operate in a particular orientation, Therefore, it should not be construed as a limitation of the present invention. Furthermore, the terms "first", "second", and "third" are used for descriptive purposes only and should not be construed to indicate or imply relative importance.

In addition, it should also be noted that, in the description of the present invention, unless otherwise expressly 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 a It is a detachable connection, or an integral connection; it can be a mechanical connection; it can be directly connected, or it can be indirectly connected through an intermediate medium, and it can be internal communication between two components. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

The term "comprising" or any other similar term is intended to encompass a non-exclusive inclusion such that a process, method, article or device/means comprising a list of elements includes not only those elements but also other elements not expressly listed, or Also included are elements inherent to these processes, methods, articles or devices/devices.

So far, the technical solutions of the present invention have been described with reference to the preferred embodiments shown in the accompanying drawings, however, those skilled in the art can easily 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 (10)

1. a transcatheter aortic prosthetic valve, comprising a grid-like and radially capable of compressing and deploying a stent and the artificial valve leaflet installed on the inner side of the stent, wherein the stent has an inflow end and an outflow end , at the outflow end of the bracket, there are a plurality of fixed parts that are opened outward and bent downward to form semi-annular barbs, one end of the fixed part is connected to the bracket, and the other end faces the direction of the free end of the inflow end . 2 . The transcatheter aortic prosthetic valve according to claim 1 , wherein a plurality of adjustment parts are also provided at the outflow end of the stent, and one end of the adjustment part is connected to the stent, and the other end is expanded outward. 3 . Open and bend downward in a barb-like manner toward the outer side wall of the bracket, or flare outward and upward. 3 . The transcatheter aortic prosthetic valve according to claim 2 , wherein the fixing portion and the adjusting portion are arranged at equal intervals. 4 . 4. The transcatheter aortic prosthetic valve according to claim 2, wherein the number of the fixing part and the adjusting part is equal, The fixing part and the bracket form a closed first mesh hole, the adjusting part and the bracket form a closed second mesh hole, and the second mesh hole is located between the first mesh hole. Inside. 5 . The transcatheter aortic prosthetic valve according to claim 2 , wherein the adjusting part is provided with a connecting piece for connecting the adjusting cable of the delivery system. 6 . 6. The transcatheter aortic prosthetic valve according to claim 5, wherein the connecting member is a threaded hole, which can be screwed with the adjusting cable; or The connecting piece is a locking head, which can be locked with the locking groove on the adjusting cable; or The connecting piece is a locking groove, which can be locked with the locking head on the adjusting cable. 7. transcatheter aortic prosthetic valve as claimed in claim 2 is characterized in that, described outflow end is laterally provided with 12 rhombus meshes, thereby forming 12 vertices, and every 4 continuous described vertices form a connection The two outermost vertices in each of the connecting areas are respectively connected to the same fixing part, and the two innermost vertices in each of the connecting areas are respectively connected to the same adjusting part. 8. The transcatheter aortic prosthetic valve according to any one of claims 1 to 7, wherein the stent is laser-cut or woven based on shape memory alloy and/or superelastic alloy material. 9. A delivery system for the replacement of aortic valve in a subject's heart, wherein the system comprises a delivery tube sheath that can be inserted into the subject's aorta, arranged at a distance from the delivery tube sheath an end receiving sheath and a transcatheter aortic prosthetic valve as claimed in 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 sheath, and the transcatheter aortic valve is in a compressed state. The remainder of the prosthetic valve is placed within the containment sheath. 10. A delivery method for replacement of a heart aortic valve in a subject, wherein the delivery method comprises: providing a delivery system as claimed in claim 9; delivering the containment sheath below the aortic annulus to enter the left ventricular outflow tract based on the passage of the delivery sheath through the peripheral artery of the subject; Fixing the accommodating tube sheath and withdrawing the delivery sheath tube, releasing the fixing part and the adjusting part, so that the fixing part opens outward and forms a semi-annular barb into the aortic sinus; Fixing the delivery sheath and adjusting the cable, moving the accommodating sheath forward and releasing the stent, so that the stent is deployed and fixed in the in-situ aortic valve area; The adjusting portion is further released, and the adjusting portion is expanded to form a barb directed toward the outer side wall of the stent to further clamp and fix the in-situ aortic valve.

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