CN117137683A

CN117137683A - Anchor stent, heart valve regurgitation replacement assembly and anchor stent conveying device

Info

Publication number: CN117137683A
Application number: CN202311181492.4A
Authority: CN
Inventors: 金昌�; 李柯
Original assignee: Xinyi Medical Technology Beijing Co ltd
Current assignee: Xinyi Medical Technology Beijing Co ltd
Priority date: 2023-09-13
Filing date: 2023-09-13
Publication date: 2023-12-01

Abstract

The invention provides an anchoring support, a heart valve reflux replacement component and an anchoring support conveying device, and relates to the field of medical equipment, wherein the anchoring support comprises an atrial ring, a support ring and a connecting part: the support rings are arranged at the proximal end side of the atrial ring, at least two layers of support rings are arranged along the axial direction, the adjacent two layers of support rings are connected end to end, and all the support rings are discontinuous in the respective circumferential sections; the atrial ring is connected with the most distal supporting ring, each layer of supporting ring, and the most proximal supporting ring is connected with the atrial ring through connecting parts respectively; the maximum diameter of the ring surface of the support ring is smaller than the maximum diameter of the ring surface of the atrial ring, and the atrial ring and the furthest support ring are clamped with each other. The heart valve regurgitation replacement assembly comprises a prosthetic valve prosthesis and the aforementioned anchor stent, the anchor stent delivery device being configured to deliver the aforementioned anchor stent into a patient. The application of the invention can rapidly complete the anchoring of the artificial valve at the native position of the mitral valve or tricuspid valve with a simple structure and procedure without damaging the subvalvular structure.

Description

Anchor stent, heart valve regurgitation replacement assembly and anchor stent conveying device

Technical Field

The invention relates to the field of medical equipment, in particular to an anchoring bracket, a heart valve reflux replacement component and an anchoring bracket conveying device.

Background

The transcatheter aortic valve replacement is to send the artificial heart valve to the aortic valve area to open through the femoral artery to complete the implantation of the artificial valve and restore the valve function; the transcatheter mitral valve replacement and transcatheter tricuspid valve replacement are used for treating congenital mitral valve regurgitation and tricuspid valve regurgitation, unlike aortic valve replacement, anchoring can be accomplished by radial support force, typically, mitral valve or tricuspid valve regurgitation is not accompanied by calcification, and the annulus is large in size and non-circular, and dynamically changes during systole, the shape and size of the annulus constantly changes, and the difficulty in anchoring a prosthetic valve is greatly increased when the mitral valve or tricuspid valve is replaced through transcatheter intervention.

Currently, when replacing the mitral or tricuspid valve via a catheter intervention, anchoring of the prosthetic valve is accomplished mainly by: (1) a tip tether: the artificial valve is connected with the apex of the heart by a rope with a certain tension to replace part of the physiological functions of the original chordae to achieve the anchoring of the artificial valve, but the way damages the apex muscles and simultaneously limits the implantation path from being capable of stranding; (2) leaflet grabbing: grasping the leaflet with 3 barbs to achieve anchoring increases prosthetic valve stability, but may cause leaflet damage or tearing; (3) annuloplasty: the barb is used for supporting the valve annulus, but the valve Zhou Loufeng is high in risk and can damage the valve annulus; (4) radial interference: the larger interference and the barbs act together to realize anchoring, so that the operation is convenient, and the defect is that the original subvalvular structure of the mitral valve is damaged, and the risks of obstruction of the left ventricular outflow tract LVOT (Left Ventricular Outflow Tract) and paravalvular leakage are increased; (5) atrial anchoring: placing the entire prosthetic valve completely in the atrium, with the risk of causing enlargement of the left atrium; (6) hoop structure: the artificial valve is characterized in that the artificial valve and the valve She Tiege are more compact, but the artificial valve is implanted while the hoop is operated to lock the artificial valve and the valve, so that the process is complex and the operation is time-consuming.

Disclosure of Invention

The invention aims to provide an anchoring bracket, a heart valve reverse flow replacement component and an anchoring bracket conveying device, so that anchoring of a prosthetic valve at a primary position of a mitral valve or a tricuspid valve can be rapidly completed in a simple structure and steps, the subvalvular structure is not damaged, and the technical problems in the prior art are further relieved.

In order to achieve the above purpose, the embodiment of the present invention adopts the following technical scheme:

in a first aspect, embodiments of the present invention provide an anchoring stent comprising an atrial ring, a support ring, and a connection portion;

wherein: axial with the direction perpendicular to the annulus of the atrial ring: the support ring is arranged at the proximal end side of the atrial ring, at least two layers of support rings are arranged along the axial direction, the adjacent two layers of support rings are connected end to end, and all the support rings are discontinuous in respective circumferential sections; the atrial ring and the most distal supporting ring, the supporting rings of each layer and the most proximal supporting ring and the atrial ring are respectively connected through the connecting parts; the atrial ring and the support ring are radially compressible and spring back in a released state: the largest diameter of the ring surface of the supporting ring is smaller than the largest diameter of the ring surface of the atrial ring, and the atrial ring and the furthest supporting ring are clamped with each other.

In a second aspect, embodiments of the present invention also provide a heart valve regurgitation replacement assembly comprising a prosthetic valve prosthesis and an anchoring stent according to any of the preceding embodiments; wherein: the prosthetic valve prosthesis comprises a prosthetic stent and a prosthetic valve connected to the prosthetic stent, wherein the prosthetic stent can be released inside the anchoring stent and automatically expanded and supported by the anchoring stent, and barbs or barbs capable of locking the prosthetic stent to the supporting ring are arranged on the outer circumferential surface of the prosthetic stent.

According to the anchoring stent provided by the invention, the anchoring stent is arranged on the basis of the hoop structure, when the anchoring stent is placed in a patient, the atrial ring is released to clamp the valve annulus, the supporting ring is arranged below the valve leaflet through rotation, the connecting part is positioned at the natural valve leaflet involution position, the anchoring stent is stably positioned at the valve annulus through the supporting ring and the atrial ring, the native valve She Kezheng of the patient is normally opened, then the artificial valve prosthesis is further implanted into the anchoring stent, the artificial valve prosthesis can be self-adaptively locked with the anchoring stent without additional operation, and the valve leaflet is clamped between the artificial valve prosthesis stent and the anchoring stent, so that the anchoring of the artificial valve prosthesis is completed, the subvalvular structure is not damaged, and the anchoring stent has good sealing performance.

In various optional embodiments of the anchoring stent provided in the first aspect of the present embodiment, the anchoring stent is formed by winding a single wire or a memory wire end to end; or the anchoring bracket is formed by fixedly winding a plurality of metal wires and/or memory wires end to end.

In various alternative embodiments of the anchoring stent provided in the first aspect of the present embodiment, it is preferable that the atrial ring and/or the support ring is a ring or a D-ring.

In each optional implementation manner of the anchoring stent provided in the first aspect of the present embodiment, preferably, a covering film is connected to a peripheral surface of a continuous portion in each ring structure of the anchoring stent in a covering manner.

In each alternative implementation manner of the anchoring stent provided in the first aspect of the present embodiment, preferably, with an axial distance between the annular surface of the atrial ring and the annular surface of the axially most distal support ring being h1, 1mm is less than or equal to h1 is less than or equal to 8mm, and more preferably, 2mm is less than or equal to h1 is less than or equal to 5mm; and/or, with an axial spacing h2 between the annulus of the atrial ring and the annulus of the axially nearest support ring, h2 is 1mm < 10mm, and more preferably, h2 is 2mm < 6mm.

In each alternative implementation manner of the anchoring support provided in the first aspect of the present embodiment, more preferably, each layer of the supporting ring includes at least two arc segments in a circumferential direction, and the length of a connecting line between two end points where two adjacent arc segments are close to each other is t, then t is more preferably less than or equal to 0.5mm and less than or equal to 10mm, and still more preferably, t is more preferably less than or equal to 2mm and less than or equal to 5mm.

Further preferably, the end of each arc-shaped section is turned towards the outside of the supporting ring, and if the turning angle is alpha, the angle alpha is more than or equal to 0 degree and less than or equal to 90 degrees.

In various optional embodiments of the anchoring stent provided in the first aspect of the present embodiment, preferably, the anchoring stent further includes a hanging ring structure protruding axially distally from an annulus of the atrial ring or protruding axially proximally from an annulus of a layer of support ring on a proximal-most side; the hanging ring structure is connected with the atrial ring or the supporting ring or the connecting part.

In a third aspect, embodiments of the present invention also provide an anchoring stent delivery device for delivering an anchoring stent according to any one of the preceding first aspects into a patient;

wherein: the anchoring stent conveying device comprises an outer layer catheter, a middle layer pushing pipe and an inner layer guiding pipe which are sleeved in sequence from an outer layer to an inner layer; the front end of the inner layer guide pipe is fixedly connected with a conical hollow guide head; the front end of the middle layer pushing pipe is fixedly connected with a positioning head, and a protruding part capable of hooking a bending area on the anchoring bracket is arranged on the positioning head; in a conveying state, the anchoring support is sleeved outside the inner-layer guide pipe and is positioned outside the area between the guide head and the positioning head, and the bending area of the anchoring support is hooked on the protruding part; the middle pushing tube and the outer catheter can move axially relatively so as to accommodate or release the anchoring stent into the front end lumen of the outer catheter.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.

FIG. 1A is a schematic representation of a human heart anatomy;

FIG. 1B is a schematic diagram of a human heart anatomy;

FIG. 2 is an isometric view of the overall structure of a first alternative embodiment of an anchor bracket provided by an embodiment of the present invention;

FIG. 3 is a top view of the anchor bracket shown in FIG. 2;

FIG. 4 is a front view of the anchor bracket shown in FIG. 2;

FIG. 5 is a right side view of the anchor bracket shown in FIG. 2;

FIG. 6 is a block diagram of the assembly of a first alternative structure of the anchoring stent with the prosthetic stent of the prosthetic valve prosthesis from the perspective of FIG. 2;

FIG. 7 is a block diagram of the assembly of a first alternative structure of the anchoring stent with the prosthetic stent of the prosthetic valve prosthesis from the perspective of FIG. 3;

FIG. 8 is a block diagram of the assembly of a first alternative structure of the anchoring stent with the prosthetic stent of the prosthetic valve prosthesis from the perspective of FIG. 4;

FIG. 9 is a block diagram of the assembly of a first alternative structure of the anchoring stent with the prosthetic stent of the prosthetic valve prosthesis from the perspective of FIG. 5;

FIG. 10 is a state diagram after implantation of a first alternative structure of the anchoring stent into a human body;

FIG. 11 is a view of the prosthetic valve prosthesis further released after implantation within the anchoring stent (prosthetic valve on the prosthetic stent not shown) based on FIG. 10;

FIG. 12 is an isometric view of the overall structure of a second alternative embodiment of an anchor bracket provided by an embodiment of the present invention;

FIG. 13 is a top view of the anchor bracket shown in FIG. 12;

FIG. 14 is a front view of the anchor bracket shown in FIG. 12;

FIG. 15 is a right side view of the anchor bracket shown in FIG. 12;

FIG. 16 is a block diagram of an anchor stent according to an embodiment of the present invention sleeved outside an inner guide tube of a delivery device;

FIG. 17 is a schematic view of the structure of the protruding portion of the connecting portion bending region of the anchoring bracket hooked on the front positioning head of the middle pushing rod of the conveying device based on FIG. 16;

FIG. 18 is a cross-sectional view of FIG. 16;

fig. 19 is an enlarged view of a part of the positioning head of the front end of the middle pushing rod of the conveying device according to the embodiment of the present invention from the view of fig. 16.

Icon: 100-a prosthetic scaffold; 1-atrial ring; 2-a support ring; 3-connecting part; 4-hanging ring structure; 5-outer catheter; 6-pushing the pipe in the middle layer; 61-positioning head; 610-concave ramp; 611-a boss; 7-an inner layer guide tube; 71-guide head.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. The components of the embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the invention, as presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

It should be noted that: like reference numerals and letters designate like items in the drawings, and thus once an item is defined in one drawing, no further definition or explanation thereof is necessary in the subsequent drawings.

In the description of the present invention, it should be noted that, directions or positional relationships indicated by terms such as "proximal", "distal", "front", "rear", "inner", "outer", etc., are directions or positional relationships based on those shown in the drawings, or are directions or positional relationships conventionally put in use of the inventive product, are merely for convenience of describing the present invention and simplifying the description, and are not indicative or implying that the apparatus or element to be referred to must have a specific direction, be configured and operated in a specific direction, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like, are used merely to distinguish between descriptions and should not be construed as indicating or implying relative importance.

In the description of the present invention, it should also be noted that, unless explicitly specified and limited otherwise, the terms "disposed," "mounted," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.

Some embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following embodiments and features of the embodiments may be combined with each other without conflict.

The first aspect of the present embodiment provides an anchoring stent comprising an atrial ring 1, a support ring 2 and a connection 3, see fig. 2 to 5.

As shown in fig. 1A and 1B, in the heart structure of the human body, the mitral valve can ensure that blood enters the left ventricle from the left atrium, the tricuspid valve can ensure that blood flows from the right atrium to the right ventricle, so that during operation, the delivery device is close to one end of the operator, namely the rear end is the proximal end of the delivery device, and the front end of the delivery device is the distal end of the delivery device; the upstream end of the blood flow direction is the distal end of the anchoring bracket after implantation, and the downstream end of the blood flow direction is the proximal end of the anchoring bracket.

Wherein: axial direction is perpendicular to the annulus of the atrial ring 1: the support rings 2 are arranged on the proximal end side of the atrial ring 1, at least two layers of support rings 2 are arranged along the axial direction, the adjacent two layers of support rings 2 are connected end to end, and all the support rings 2 are discontinuous in respective circumferential sections; the atrial ring 1 and the most distal support ring 2, the support rings 2 of each layer, and the most proximal support ring 2 and the atrial ring 1 are respectively connected by connecting parts 3.

The atrial ring 1 and the support ring 2 are radially compressible and spring back in the released state: the largest diameter d2 of the annulus of the support ring 2 is smaller than the largest diameter d1 of the annulus of the atrial ring 1, the condition of mutual clamping between the atrial ring 1 and the most distal support ring 2.

With reference to fig. 1A, 1B, 10 and 11, the anchoring stent may be used in the treatment of mitral or tricuspid regurgitation for anchoring a valve during replacement of the mitral or tricuspid valve by catheter-mediated delivery of a prosthetic valve prosthesis.

In particular, as shown in fig. 6 to 9, the second aspect of the present embodiment further provides a heart valve regurgitation replacement assembly, which includes a prosthetic valve prosthesis and the aforementioned anchoring stent, wherein the prosthetic valve prosthesis is of a structure commonly known in the art, and mainly includes a prosthetic valve (not shown) connected to the prosthetic stent 100, the prosthetic stent 100 can be released inside the anchoring stent and automatically expanded to be supported on the anchoring stent, and barbs or barbs capable of locking the prosthetic stent 100 to the support ring 2 are provided on the outer circumferential surface of the prosthetic stent 100.

Taking the replacement of a mitral valve through catheter and transapical access as an example, during operation, firstly, pressing a part of the anchoring bracket into an outer tube of a conveying device of the device, locking a bending region of the anchoring bracket and a pushing assembly arranged in the outer tube of the conveying device together, rotating the anchoring bracket along the same or opposite directions so as to screw all the supporting ring 2 and the atrial ring 1 into the outer tube, wherein the atrial ring 1 faces the front end (distal end) of the outer tube and the supporting ring 2 faces the rear end (proximal end) of the outer tube, and at the moment, the two adjacent layers of the supporting rings 2 are in a loading state of 0-degree or 180-degree rotation angle and 90-degree rotation angle compression between the atrial ring 1 and the most distal supporting ring 2;

then, the outer tube loaded with the anchoring bracket is stretched to the anatomical position of the patient's mitral valve through the apex access, the atrial ring 1 is released firstly, the mitral valve annulus is blocked, then the supporting ring 2 is released by rotating the outer tube while releasing, or the supporting ring 2 is released firstly in a half way, then the outer tube is rotated, the outer tube is enabled to rotate at the annulus with the anchoring bracket, finally, the bending area of the anchoring bracket locked together with a pushing component arranged in the outer tube by a conveying device is released, the release of the anchoring bracket is completed, the supporting ring 2 is enabled to avoid the valve leaflet and chordae tendineae in gaps formed discontinuously in respective circumferential sections by rotating the outer tube, the supporting ring 2 is enabled to be sleeved between the valve leaflet and the ventricular wall, and the chordae tendineae are not damaged; after release, as shown in fig. 10, the anchoring stent can be secured in the annulus position under the clamping action of the atrial ring 1 and the support ring 2 without affecting the opening and closing of the patient's native leaflets.

Then, the artificial mitral valve prosthesis is implanted into the anchoring bracket, and as shown in fig. 6 to 9 and 11, the prosthesis bracket 100 of the artificial mitral valve prosthesis self-expands to squeeze the native valve leaflets to the support ring 2, and the artificial mitral valve is positioned and sealed by locking the barbs or hooks on the prosthesis bracket 100 with the support ring 2.

In particular, the above procedure for replacing the mitral valve by transcatheter or transapical approach may be performed by replacing the mitral valve by transcatheter or transfemoral approach, wherein the atrial ring 1 is loaded into the outer tube of the transporter toward the rear end (proximal end) of the outer tube and the support ring 2 is loaded toward the front end (distal end) of the outer tube, and when released, the support ring 2 is released first, and then the atrial ring 1 is released after rotating and releasing through the valve She Hejian cable.

The tricuspid valve is replaced by a catheter intervention to be similar.

According to the anchoring stent provided by the invention, the anchoring stent is arranged on the basis of a hoop structure, when the anchoring stent is placed in a patient, the atrial ring 1 is released to clamp the valve annulus, the supporting ring 2 is placed below the valve leaflet through rotation, the connecting part 3 is positioned at the natural valve leaflet involution position, the anchoring stent is stably fixed at the valve annulus through the supporting ring 2 and the atrial ring 1, the native valve She Kezheng of the patient is normally opened, then the artificial valve prosthesis is further implanted into the anchoring stent, no additional operation is needed, the prosthesis stent 100 of the artificial valve prosthesis can be self-adaptively locked with the anchoring stent after self-expansion, the valve leaflet is clamped between the prosthesis stent 100 and the anchoring stent of the artificial valve prosthesis, anchoring of the artificial valve prosthesis is completed, the subvalvular structure is not damaged, and the anchoring stent has good sealing performance. In the anchoring stent provided in the first aspect of the present embodiment, further:

in some alternative embodiments, the anchoring stent is formed by winding a single wire or memory wire end to end; in other alternative embodiments, the anchoring bracket is formed by fixedly winding a plurality of metal wires and/or memory wires end to end, and the connection part can be selected from specific connection modes such as riveting or welding. In this embodiment, the selected memory wire is selected from nickel-titanium alloy materials, the low temperature variability of which can automatically restore the shape.

In addition, the annulus of the atrial ring 1 and the annulus of each layer of support ring 2 may or may not be parallel to each other, and preferably, but not limited to, the annulus diameters of each layer of support rings 2 are the same, and preferably, but not limited to, all support rings 2 are discontinuous in the same lateral sections in the respective circumferential directions.

In some alternative embodiments, it is preferred that the atrial ring 1 is continuous or discontinuous in its circumferential direction; and/or the atrial ring 1 is a circular ring or a D-ring; and/or the support ring 2 is a circular ring or a D-shaped ring, of course, the atrial ring 1 and the support ring 2 can also be of alternative regular or irregular annular structures such as square rings.

In some alternative embodiments, preferably, the peripheral surface of the continuous non-breaking part in each ring structure of the anchoring support is covered and connected with a covering film, so as to increase the blood tightness of the peripheral part of the anchoring support, further avoid peripheral leakage, and the covering film can be made of fabric or polymer material, so as to increase the adaptability of human body.

In some alternative embodiments, more preferably, with an axial spacing h1 between the annulus of the atrial ring 1 and the annulus of the axially most distal support ring 2, 1 mm.ltoreq.h1.ltoreq.8mm, and still more preferably, 2 mm.ltoreq.h1.ltoreq.5mm; and/or, with an axial spacing h2 between the annulus of the atrial ring 1 and the annulus of the axially nearest support ring 2, 1 mm.ltoreq.h2.ltoreq.10mm, and further preferably 2 mm.ltoreq.h2.ltoreq.6mm.

In some alternative embodiments, more preferably, each layer of support ring 2 comprises at least two arc-shaped sections in the circumferential direction, and the length of a connecting line between two end points where two adjacent arc-shaped sections are close to each other is t, then t is more preferably more than or equal to 0.5mm and less than or equal to 10mm, and more preferably, t is more preferably more than or equal to 2mm and less than or equal to 5mm.

Further preferably, the ends of the arc-shaped sections are folded towards the outside of the supporting ring 2, and the folding angle is alpha, then alpha is more than or equal to 0 degrees and less than or equal to 90 degrees.

In some alternative embodiments, it is preferable that the anchoring stent further comprises a hanging ring structure 4 protruding axially distally from the annulus of the atrial ring 1 or protruding axially proximally from the annulus of the proximal-most layer of support rings 2; the hanging ring structure 4 is connected with the atrial ring 1 or the supporting ring 2 or the connecting part 3; in each connection mode, it is preferable that the hanging ring structure 4 is formed by bending the connection portion 3 as shown in fig. 2 to 5, or that the hanging ring structure 4 is formed by bending the atrial ring 1 as shown in fig. 12 to 15.

In addition, a third aspect of the present embodiment provides an anchoring stent delivery device for delivering an anchoring stent provided by any of the alternative embodiments of the first aspect described above into a patient.

Specifically, referring to fig. 16 to 19, the anchoring stent delivery device comprises an outer catheter 5, a middle push tube 6 and an inner guide tube 7 which are sleeved in sequence from the outer layer to the inner layer; the front end of the inner layer guide pipe 7 is fixedly connected with a conical hollow guide head 71; the front end of the middle pushing tube 6 is fixedly connected with a positioning head 61, and the positioning head 61 is provided with a protruding part 611 which can be hooked on a bending area on the anchoring bracket.

In the conveying state, the anchoring bracket is sleeved outside the inner-layer guide pipe 7 and is positioned outside the area between the guide head 71 and the positioning head 61, and the bending area of the anchoring bracket is hooked on the protruding part 611; the middle pushing tube 6 and the outer catheter 5 can move axially relatively so as to accommodate or release the anchoring stent into the front end lumen of the outer catheter 5. The hollow structure of the guide head 71 and the lumen of the inner guide tube 7 are used for introducing a guide wire for guiding the guide wire in an access way during the interventional operation, and the conical structure of the guide head 71 can reduce the interventional resistance.

Preferably, the anchoring stent comprises a hanging ring structure 4, wherein the hanging ring structure 4 is assembled and locked with the protruding part 611, at least two hanging ring structures 4 are arranged along the radial direction of the annular surface of the atrial ring 1, the protruding part 611 comprises two opposite side surfaces arranged on the positioning head 61, each hanging ring structure 4 is respectively hung on the protruding part 611 on the same side and then is restrained in the outer catheter 5, so that the locking efficiency is improved, meanwhile, the locking stability is ensured, and the anchoring stent is prevented from accidentally falling out of the outer catheter 5 when being delivered into a patient.

In addition, it is preferable that a concave slope 610 is provided at a region where the above-mentioned convex portion 611 is provided at the side of the positioning head 61 as shown in fig. 19, so as to reduce the diameter of the outer tube required for loading, so that the outer tube is more easily passed through the tortuous vessels and is more easily handled.

Finally, it should be noted that:

1. in the present specification, "and/or" means "and/or" preceding structure is provided simultaneously or alternatively with "and/or" following structure;

2. in the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described by differences from other embodiments, and identical and similar parts between the embodiments are only required to be seen with each other; the above embodiments in the present specification are only for illustrating the technical solution of the present invention, and are not limiting; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the invention.

Claims

1. An anchoring stent, characterized in that: comprises an atrial ring (1), a support ring (2) and a connecting part (3):

axial with the direction perpendicular to the annulus of the atrial ring (1): the supporting rings (2) are arranged on the proximal end side of the atrial ring (1), at least two layers of supporting rings (2) are arranged along the axial direction, the adjacent two layers of supporting rings (2) are connected end to end, and all the supporting rings (2) are discontinuous in respective circumferential sections;

the atrial ring (1) is connected with the most far end supporting ring (2), each layer of supporting ring (2) and the most far end supporting ring (2) are connected with the atrial ring (1) through the connecting parts (3);

the atrial ring (1) and the support ring (2) are radially compressible and spring back in the released state: the largest diameter of the ring surface of the supporting ring (2) is smaller than the largest diameter of the ring surface of the atrium ring (1), and the atrium ring (1) and the furthest end of the supporting ring (2) are clamped with each other.

2. An anchoring stent as defined in claim 1, wherein: the anchoring bracket is formed by winding a single metal wire or a memory wire in an end-to-end manner;

or the anchoring bracket is formed by fixedly winding a plurality of metal wires and/or memory wires end to end.

3. An anchoring stent as defined in claim 1, wherein:

the atrial ring (1) and/or the support ring (2) are annular or D-shaped rings.

4. An anchoring stent as defined in claim 1, wherein: the peripheral surface of the continuous part in each ring structure of the anchoring bracket is covered and connected with a covering film.

5. An anchoring stent as defined in claim 1, wherein: taking the axial distance between the annular surface of the atrial ring (1) and the annular surface of the axially most far end supporting ring (2) as h1, wherein h1 is more than or equal to 1mm and less than or equal to 8mm; and/or, with an axial distance h2 between the annulus of the atrial ring (1) and the annulus of the axially nearest support ring (2), h2 is 1mm < 10mm.

6. An anchoring stent as defined in claim 1, wherein: each layer of the supporting ring (2) comprises at least two arc-shaped sections in the circumferential direction, and the length of a connecting line between two end points, which are mutually close to each other, of each two adjacent arc-shaped sections is t, then t is more than or equal to 0.5mm and less than or equal to 10mm.

7. The anchor bracket of claim 6, wherein: the end parts of the arc-shaped sections are turned towards the outside of the supporting ring (2), and if the turning angle is alpha, the alpha is more than or equal to 0 degrees and less than or equal to 90 degrees.

8. An anchoring stent as defined in claim 1, wherein: the anchoring bracket also comprises a hanging ring structure (4) which axially protrudes out of the annular surface of the atrial ring (1) in the distal direction or protrudes out of the annular surface of a layer of supporting ring (2) at the nearest end side in the proximal direction; the hanging ring structure (4) is connected to the atrial ring (1) or the support ring (2) or the connecting part (3).

9. A heart valve regurgitation replacement assembly, characterized by: comprising a prosthetic valve prosthesis and an anchoring stent according to any one of claims 1 to 8, the prosthetic valve prosthesis comprising a prosthetic stent (100) and a prosthetic valve connected to the prosthetic stent (100), the prosthetic stent (100) being releasable inside the anchoring stent and being self-expanding supported to the anchoring stent, and the prosthetic stent (100) being provided with barbs or barbs on its outer circumferential surface capable of locking the prosthetic stent (100) to the support ring (2).

10. An anchoring stent delivery device, characterized in that: an anchoring stent as defined in any one of claims 1 to 8 for delivery into a patient;

the anchoring stent conveying device comprises an outer layer catheter (5), a middle layer pushing pipe (6) and an inner layer guiding pipe (7) which are sleeved in sequence from an outer layer to an inner layer;

the front end of the inner layer guide pipe (7) is fixedly connected with a conical hollow guide head (71);

the front end of the middle layer pushing pipe (6) is fixedly connected with a positioning head (61), and a protruding part (611) capable of hooking a bending area on the anchoring bracket is arranged on the positioning head (61);

in a conveying state, the anchoring bracket is sleeved outside the inner-layer guide pipe (7) and is positioned outside the area between the guide head (71) and the positioning head (61), and the bending area of the anchoring bracket is hooked on the protruding part (611); the middle pushing tube (6) and the outer catheter (5) can move axially relatively so as to accommodate or release the anchoring stent into the front end lumen of the outer catheter (5).