阅读说明：本技术 一种瓣膜支架及包括其的介入二尖瓣置换系统 (Valve support reaches intervention mitral valve replacement system including it ) 是由 杨军 李昊松 张丽 于 2021-09-18 设计创作，主要内容包括：本发明提供一种瓣膜支架及包括其的介入二尖瓣置换系统。所述瓣膜支架包括金属框架,所述金属框架的一端边缘处沿周向外沿设置有支撑环；所述金属框架由曲面直壁和平面直壁围成,形成D形直筒状结构；所述金属框架的两端分别设置有两股连接丝,所述两股连接丝分别将金属框架两端曲面直壁边缘和平面直壁边缘连接；且每端的两股连接丝分别呈X形相交,将金属框架的两端的界面切割成8字形。所述瓣膜支架用于后续介入二尖瓣膜的支撑、固定和密封。(The invention provides a valve stent and an interventional mitral valve replacement system comprising the same. The valve support comprises a metal frame, wherein a support ring is arranged at the edge of one end of the metal frame along the circumferential outer edge; the metal frame is formed by enclosing a curved surface straight wall and a plane straight wall to form a D-shaped straight cylindrical structure; two ends of the metal frame are respectively provided with two connecting wires, and the two connecting wires respectively connect the curved straight wall edges and the plane straight wall edges at the two ends of the metal frame; and the two connecting wires at each end are respectively intersected in an X shape, and the interfaces at the two ends of the metal frame are cut into a shape like a Chinese character '8'. The valve support is used for supporting, fixing and sealing a mitral valve for subsequent intervention.)

1. The valve support is characterized by comprising a metal frame, wherein a support ring is arranged at one end edge of the metal frame along the circumferential outer edge;

the metal frame is formed by enclosing a curved surface straight wall and a plane straight wall to form a D-shaped straight cylindrical structure;

two ends of the metal frame are respectively provided with two connecting wires, and the two connecting wires respectively connect the curved straight wall edges and the plane straight wall edges at the two ends of the metal frame; and the two connecting wires at each end are respectively intersected in an X shape, and the interfaces at the two ends of the metal frame are cut into a shape like a Chinese character '8'.

2. The valve stent of claim 1, wherein the X-shaped intersection parts of the two connecting wires are welding sections, and the length of each welding section accounts for 10-20% of the length of each connecting wire;

preferably, the material of the connecting wire comprises nickel titanium alloy.

3. The valve holder according to claim 1 or 2, wherein the support ring is composed of a plurality of U-shaped structures of metal wires extending from a metal frame;

preferably, the included angle between the U-shaped structure and the metal frame is 50-80 degrees;

preferably, the vertical distance from the open end of the U-shaped structure to the bottom end of the U-shaped structure is 6-12 mm;

preferably, the height of the U-shaped structure is 6-12 mm;

preferably, the U-shaped structures are isolated from each other and are not tangled;

preferably, the number of the U-shaped structures is at least 6, preferably 6-20;

preferably, the U-shaped structure is made of nickel titanium alloy.

4. The valve stent of any one of claims 1-3, wherein the support ring further comprises a fabric layer wrapped between the U-shaped structures;

preferably, the fabric layer comprises polyester and/or PTFE.

5. The valve stent of any one of claims 1-4, wherein the metal frame is made of a memory alloy, preferably a nickel-titanium alloy;

preferably, the metal frame is a net structure;

preferably, the metal frame is a diamond mesh structure.

6. The valve holder according to any one of claims 1-5, wherein the outer circumferential surface of the metal frame is obliquely provided with at least one barb-type anchor;

preferably, the overhead hook type anchors are arranged at the vertexes of the rhombic net structures, and only one overhead hook type anchor is arranged at the vertexes of the rhombic net structures connected with each other;

preferably, the barb-type anchor is a spike-shaped structure, and the barb-type anchor is arranged obliquely downwards along the direction from the left ventricle to the left atrium;

preferably, the angle of inclination of the barb anchor is 30-70 °;

preferably, the length of the barb anchor is 1-3 mm.

7. The valve stent of any one of claims 1-6, wherein the metal frame further comprises a fabric layer wrapped inside the metal frame;

preferably, the fabric layer comprises polyester and/or PTFE.

8. The valve stent according to any one of claims 1 to 7, wherein the valve stent has a compressed configuration and a deployed configuration, the valve stent is implanted in the body by means of a delivery device in the compressed configuration, and the implantation target site is switched to the deployed configuration so as to be fixed at the valve; in the deployed configuration, the support ring is in the left atrium and the metal frame is in the left ventricle, securing the valve stent with an inverted hook anchor.

9. An interventional mitral valve replacement system comprising the valve stent of any one of claims 1-8.

10. The interventional mitral valve replacement system of claim 9, wherein at least two interventional mitral valves are disposed within the valve holder.

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a valve stent and an interventional mitral valve replacement system comprising the same.

Background

Mitral Regurgitation (Mitral Regurgitation), a common heart valve disease, is classified into four cases, mild, moderate and severe depending on the degree of disease, with moderate MR having a 1.7% incidence in the population and approaching 10% with increasing age in those older than 74 years. At present, intervention mitral valve treatment technology is mostly adopted in treatment modes for patients with mitral valve regurgitation, and the treatment modes are generally divided into two modes, namely repair and replacement. However, mitral valve replacement is still required when the mitral valve repair procedure is not adequate for therapeutic efficacy, and the patient is often unable to undergo surgery again under his own conditions, and therefore Transcatheter Mitral Valve Replacement (TMVR) is required.

In recent years, TMVR is the leading research hotspot in the international cardiac intervention field, provides an effective means for the treatment of mitral valve diseases, and compared with the traditional surgical treatment, TMVR does not need to open the chest, stop the heart, circulate in vitro, has the advantages of small trauma, less bleeding, quick recovery and the like, and thus is widely concerned and researched by scholars.

CN111035472A discloses a valve stent, which comprises a stent main body arranged in a grid shape, at least one grasping ear connected with the stent main body and a flange. The outer diameter D of the flange is larger than the diameter D of the joint of the flange and the support main body, so that the lower horizontal plane of the flange is tightly attached to the native valve annulus of the coaptation heart and the valve leaflets, the upwarp end face of the edge is tightly attached to the inner wall of the left atrium, the upper limiting and sealing effects are achieved, and the valve support is prevented from sliding out of the left ventricle end. When the valve stent is compressed into the sheath, the grabbing ears are embedded into the grids of the stent main body connected with the grabbing ears, so that the thickness of the stent after the diameter shrinkage of the valve stent is pressed and held is reduced, the valve stent can be favorably inserted into a human body through a femoral vein path, the diameter of a catheter of a conveyor is reduced, and the conveying difficulty and the injury to blood vessels are reduced.

CN112869915A discloses a valve prosthesis and a valve prosthesis system. Wherein, valve prosthesis includes: a main body portion and an anchor; the main body part includes: valve support, leaflet and shirt rim, valve support includes: the valve support comprises a first support, a second support and a connecting frame, wherein the first support is arranged on the periphery of the second support, the connecting frame is connected between the first support and the second support, valve blades are fixed on the second support, and a skirt edge covers the inner surface and/or the outer surface of the valve support; the anchor is disposed apart from the valve stent, and in use, the anchor is disposed on the first stent and extends outwardly to anchor the valvular prosthesis. The first support is fixedly connected with the valve ring through the anchoring piece, the valve prosthesis can be fixed in the left atrium, when the heart beats, the valve prosthesis can be prevented from twisting and/or shifting, the size of the whole valve prosthesis invading into the left ventricle is small, and the left ventricle outflow tract can not be obstructed.

Based on the above research, it can be seen that the valve stent, as a device commonly used in TMVR, can provide positioning and support for TMVR, achieving the effect of treating MR. However, valve stents are at risk of shifting and fail to meet the subsequent TMVR techniques. Therefore, finding a stable valve stent which accurately provides positioning and supporting for the transcatheter mitral valve replacement has important practical significance.

Disclosure of Invention

In view of the deficiencies of the prior art, it is an object of the present invention to provide a valve stent and an interventional mitral valve replacement system including the same. The valve stent is not easy to shift after being released, and provides positioning and supporting for a subsequent transcatheter mitral valve replacement valve so as to achieve better treatment effect.

In order to achieve the purpose, the invention adopts the following technical scheme:

in a first aspect, the invention provides a valve stent, wherein a support ring is arranged at one end edge of a metal frame along the circumferential outer edge; the metal frame is formed by enclosing a curved surface straight wall and a plane straight wall to form a D-shaped straight cylindrical structure; two ends of the metal frame are respectively provided with two connecting wires, and the two connecting wires respectively connect the curved straight wall edges and the plane straight wall edges at the two ends of the metal frame; and the two connecting wires at each end are respectively intersected in an X shape, and the interfaces at the two ends of the metal frame are cut into a shape like a Chinese character '8'.

The invention provides a valve support, wherein the support ring and the metal frame are designed into D-shaped sections which are matched with the physiological structure of a natural mitral valve, so that the compression of a forming ring on a heart outflow tract caused by shape mismatch can be effectively avoided, and further other complications of a patient can be caused; meanwhile, the two strands of connecting wires respectively connect the curved straight wall edges and the planar straight wall edges at the two ends of the metal frame; and the two strands of connecting wires at each end are intersected in an X shape respectively, the interfaces at the two ends of the metal frame are cut into an 8 shape, the valve support accommodating space is matched with the shape of the mitral valve more due to the arrangement, the combination is firmer, the valve support is further ensured to be tightly attached to a blood flow channel, and the valve support is matched with surrounding tissues to form a blocking structure, so that the valve support is favorable for avoiding the leakage around the valve.

In the invention, the X-shaped intersecting parts of the two connecting wires are welding sections, and the length of the welding sections accounts for 10-20% of the length of each connecting wire, and can be, for example, 10%, 12%, 14%, 16%, 18%, 20%, and the like.

Preferably, the material of the connecting wire comprises nickel titanium alloy.

Preferably, the connecting wire has a diameter of 0.4 to 1.0mm, for example, 0.4mm, 0.6mm, 0.8mm, or 1.0mm, but not limited to the values recited, and other values not recited in this range are also applicable.

In the invention, the support ring is composed of a plurality of U-shaped structures formed by metal wires extending out of a metal frame.

Preferably, the angle between the U-shaped structure and the metal frame is 50-80 °, for example, 50 °, 60 °, 70 °, 80 °, etc., but not limited to the values listed, and other values not listed in this range are also applicable.

Preferably, the vertical distance from the open end of the U-shaped structure to the bottom end of the U-shaped structure is 6-12mm, for example 6mm, 8mm, 10mm or 12mm, but is not limited to the values listed, and other values not listed in this range are equally applicable.

Preferably, the U-shaped structure has a protrusion height of 6-12mm, for example 6mm, 9mm or 12mm, but not limited to the values listed, other values not listed in this range are equally applicable.

Preferably, the U-shaped structures are isolated from each other and are not tangled.

Preferably, the number of U-shaped structures is at least 6, preferably 6-20, and may be, for example, 6, 8, 10, 12, 14, 16, 18, 20, etc., but is not limited to the recited values, and other values not recited in this range are also applicable.

Preferably, the U-shaped structure is made of nickel titanium alloy.

Preferably, the support ring further comprises a fabric layer wrapped between the U-shaped structures.

Preferably, the fabric layer comprises polyester and/or PTFE.

Preferably, the width of the opening of the U-shaped structure is 5-10mm, etc., and may be, for example, 5mm, 8mm or 10mm, but is not limited to the values listed, and other values not listed in this range are equally applicable.

Preferably, the U-shaped structure comprises a bar a, a bar B, a bar C and a bar D connected in sequence.

Preferably, the length of the rods a and B is independently 4-8mm, for example 4mm, 6mm or 8mm, but not limited to the recited values, and other values not recited in this range are equally applicable; the width of the rods A and B is independently 0.4 to 1.0mm, and may be, for example, 0.4mm, 0.8mm or 1.0mm, but is not limited to the values listed, and other values not listed in the range are also applicable.

Preferably, the length of the rods C and D is independently 3-6mm, for example 3mm, 5mm or 6mm, but not limited to the recited values, and other values not recited in this range are equally applicable; the width of the rod C and the rod D is 0.4-1mm respectively and independently; for example, the thickness may be 0.4mm, 0.8mm or 1mm, but the above range is not limited to the above range, and other ranges not listed in the above range are also applicable.

Preferably, the angle between the C and D rods is 60-120 °, such as 60 °, 80 °, 100 ° or 120 °, but not limited to the values listed, and other values not listed in this range are equally applicable

In the invention, the U-shaped structure is arranged on the outer side surface of the support ring and is in a convex shape, so that the support ring is easier to turn over.

Preferably, the metal frame is made of a memory alloy, preferably a nickel-titanium alloy.

Preferably, the metal frame is a net structure.

Preferably, the metal frame is a diamond mesh structure.

Preferably, the area of the rhombic net structure is 20-35mm²For example, it may be 20mm²、24mm²、28mm²、32mm²Or 35mm²And the like, but not limited to the recited values, and other values not recited in the range are also applicable.

The grid shape of the metal frame is designed into a diamond shape, so that the strength and the supporting force of the valve stent are improved, and the rupture of the annuloplasty ring caused by insufficient strength and supporting force is avoided.

The peripheral surface of the metal frame is obliquely provided with at least one inverted hook type anchor.

Preferably, the overhead anchors are disposed at the vertices of the diamond-shaped mesh structure, and only one overhead anchor is disposed at the vertices of the interconnected diamond-shaped mesh structure.

Preferably, the barb-type anchor is a spike-shaped structure, and is disposed obliquely downward along a direction from the left ventricle to the left atrium.

In the invention, the barb type anchoring piece is in a sharp-pricked structure, the barb type anchoring piece expands and expands under the action of external force, and the barb type anchoring piece on the outer wall of the metal frame is used for increasing friction and preventing the valve stent from falling off.

Preferably, the angle of inclination of the barb anchor is 30-70 °, such as 30 °, 40 °, 50 °, 60 °, or 70 °, but not limited to the values recited, and other values not recited in this range are equally applicable.

Preferably, the length of the barb anchor is 1-3mm, and may be, for example, 1mm, 1.5mm, 2mm, 2.5mm, or 3mm, but is not limited to the values recited, and other values not recited in this range are also applicable.

The metal frame also comprises a fabric layer wrapped on the inner side of the metal frame.

Preferably, the material of the fabric layer includes dacron and/or Polytetrafluoroethylene (PTFE).

In the invention, the valve support has a compressed form and a deployed form, the valve support is implanted into the body by means of the delivery device in the compressed form, and the implantation target position is switched to the deployed form so as to be fixed at the valve; in the deployed configuration, the support ring is in the left atrium and the metal frame is in the left ventricle, securing the valve stent with an inverted hook anchor.

Illustratively, the invention provides a method for implanting a valve stent, which comprises the following steps:

the valve support is brought into a patient body through the conveying device, when the valve support is reached to a target position, the valve support is released, the valve support can be quickly unfolded from a contraction state, the forming ring unfolding process is more flexible due to the existence of the U-shaped structure, the forming ring is easy to fold, the support ring is located in the left atrium, the metal frame is located in the left ventricle, the support ring can be clamped by a mitral valve when the heart relaxes, the valve support is prevented from sliding down to the ventricle, and when the heart contracts, the valve support can be prevented from moving to the atrium due to the action of the inverted hook type anchoring piece.

In addition, when the connecting wire is divided into two strands, in the D-shaped section, the two strands of connecting wire intersect in an X shape, and the plane is cut into an 8 shape for supporting and intervening the mitral valve. Therefore, the valve stent provided by the invention can effectively prevent the valve stent from displacing under the pressure and scouring of blood flow after being released, prolongs the service life of the valve stent after being released, reduces the damage of the valve stent to surrounding tissues, has more flexible structure, and can provide positioning and support for the subsequent transcatheter mitral valve replacement valve.

In a second aspect, the present invention provides an interventional mitral valve replacement system comprising a valve stent as described in the first aspect.

Preferably, at least two interventional mitral valves are disposed within the valve stent.

It should be noted that any desired specification for an interventional mitral valve can be adapted to the valve holder of the present invention, one of which is exemplified below as a compatible interventional mitral valve.

Preferably, the interventional mitral valve comprises a strut frame; the edge of at least one side of the strut frame is provided with an annular flanging structure; at least three biological tissue valve leaflets are arranged inside the strut frame, and the valve leaflets are connected with the strut frame through fabric.

Wherein, the flanging structure is at least arranged at the outflow side of the valve implanted in the body; preferably, the flange structures are disposed at both sides of the pillar frame.

The valve outflow side refers to the side where blood flows out of the valve, the metal frame at the end is provided with a flanging structure, the annuloplasty ring can be buckled from the left ventricle side in a reverse mode, and the valve is prevented from falling and shifting due to the pressure on the closed mitral valve outflow side during heart contraction.

Compared with the prior art, the invention has the following beneficial effects:

(1) the invention provides a valve stent, wherein a metal frame is enclosed by a curved straight wall and a plane straight wall to form a D-shaped straight cylindrical structure which is matched with the physiological structure of a natural mitral valve, so that the compression of a forming ring on a heart outflow tract caused by shape mismatch can be effectively avoided, and further other complications of a patient can be caused;

(2) the two strands of connecting wires respectively connect the curved surface straight wall edges and the plane straight wall edges at two ends of the metal frame; the two connecting wires at each end are intersected in an X shape respectively, and the interfaces at the two ends of the metal frame are cut into an 8 shape, so that the valve support is more matched with the shape of the mitral valve accommodating space, the outer wall of the forming ring is ensured to be tightly attached to a blood flow channel, and the forming structure is formed by matching with surrounding tissues, so that the valve periphery leakage is avoided, and the support, the fixation and the sealing can be provided for the subsequent intervention of the mitral valve;

(3) according to the invention, the continuous and convex U-shaped structure is arranged on the section of the support ring, so that the whole valve support is more flexible and is easy to turn over.

Drawings

FIG. 1 is a schematic view of a valve having no fabric layer between valve stents according to the present invention;

FIG. 2 is a schematic structural view of a fabric-containing layer between valve stents according to the present invention;

FIG. 3 is a front view of a layer of fabric between valve stents according to the present invention;

FIG. 4 is a side view of a fabric-containing layer between valve stents according to the present invention;

FIG. 5 is a top view of a layer of fabric between valve stents according to the present invention;

FIG. 6 is a bottom view of a fabric-containing layer between valve stents according to the present invention;

wherein, 1 is the support ring, 2 is the metal framework, 3 is the overhead kick type anchor, 4 is the connecting wire, 5 is the U-shaped structure.

FIG. 7 is a top view of a U-shaped structure in a valve stent according to the present invention;

wherein, A is pole A, B is pole B, C is pole C, D is pole D, E is the opening width of U-shaped structure, and F is the vertical distance of the open end of U-shaped structure to the bottom of U-shaped structure.

FIG. 8 is a schematic structural view of an interventional mitral valve associated with a valve stent according to the present invention;

wherein, 6-strut frame; 7-annular flanging structure; 8-biological tissue valve leaflet.

Detailed Description

It is to be understood that in the description of the present invention, the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate orientations or positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be taken as limiting the present invention. Furthermore, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.

It should be noted that, in the description of the present invention, unless otherwise explicitly specified or limited, the terms "disposed," "connected" and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.

The technical scheme of the invention is further explained by the specific implementation mode in combination with the attached drawings.

In one embodiment, the present invention provides a valve stent, as shown in fig. 1, 2, 3, 4, 5 and 6, comprising a metal frame 2 provided at one end edge thereof with a support ring 1 along a circumferential outer edge.

The metal frame 2 is formed by a curved straight wall and a plane straight wall in a surrounding mode to form a D-shaped straight cylindrical structure.

Two ends of the metal frame 2 are respectively provided with two connecting wires 4, and the two connecting wires 4 respectively connect the curved straight wall edges and the plane straight wall edges at the two ends of the metal frame 2; and the two connecting wires at each end are respectively intersected in an X shape, and the interfaces at the two ends of the metal frame 2 are cut into a shape of 8.

The invention provides a valve support, wherein the support ring and the metal frame are designed into D-shaped sections which are matched with the physiological structure of a natural mitral valve, so that the compression of a forming ring on a heart outflow tract caused by shape mismatch can be effectively avoided, and further other complications of a patient can be caused; meanwhile, the two strands of connecting wires respectively connect the curved straight wall edges and the planar straight wall edges at the two ends of the metal frame; and the two strands of connecting wires at each end are intersected in an X shape respectively, the interfaces at the two ends of the metal frame are cut into an 8 shape, the valve support accommodating space is matched with the shape of the mitral valve more due to the arrangement, the combination is firmer, the valve support is further ensured to be tightly attached to a blood flow channel, and the valve support is matched with surrounding tissues to form a blocking structure, so that the valve support is favorable for avoiding the leakage around the valve.

In the present invention, the connecting wire 4 is preferably two strands, and in the D-shaped cross section, the two strands of connecting wire 4 intersect in an X-shape and connect the planar edge of the metal frame 2 with the curved edge of the metal frame 2.

Furthermore, the X-shaped intersecting parts of the two connecting wires 4 are welding sections, and the length of each welding section accounts for 10-20% of the length of each connecting wire.

Further, the material of the connecting wire 4 includes nitinol.

Further, the diameter of the connecting wire 4 is 0.4-1 mm.

In the invention, the support ring 1 is composed of a plurality of U-shaped structures 5 formed by metal wires extending from a metal frame 2.

Furthermore, the included angle between the U-shaped structure and the metal frame is 50-80 degrees.

Further, the vertical distance from the open end of the U-shaped structure to the bottom end of the U-shaped structure is 6-12 mm.

Further, the height of the U-shaped structure 5 is 6-12 mm.

Further, the U-shaped structures 5 are isolated from each other without entanglement.

Further, the number of the U-shaped structures 5 is at least 6.

Further, the number of the U-shaped structures 5 is 6-20.

Further, the U-shaped structure 5 is made of nickel-titanium alloy.

Further, the support ring further comprises a fabric layer wrapped between the U-shaped structures.

Preferably, the fabric layer comprises polyester and/or PTFE.

Further, the opening width of the U-shaped structure is 5-10 mm.

Further, the U-shaped structure 5 comprises a rod a, a rod B, a rod C and a rod D (as shown in fig. 7) which are connected in sequence; the length of the rod A and the length of the rod B are respectively 4-8mm, and the width of the rod A and the width of the rod B are respectively 0.4-1.0 mm; the length of the rod C and the length of the rod D are respectively and independently 3-6mm, and the width of the rod C and the width of the rod D are respectively and independently 0.4-1.0 mm.

Further, the included angle between the rod C and the rod D is 60-120 degrees.

In the invention, the U-shaped structure 5 is arranged on the outer side surface of the support ring 1 and is in a convex shape, so that the support ring is easier to turn over.

Furthermore, the metal frame is made of memory alloy.

Further, the metal frame is made of nickel-titanium alloy.

Further, the metal frame is a net structure.

Further, the metal frame is of a rhombic net structure.

Further, the area of the rhombic net-shaped structure is 20-35mm²。

The grid shape of the metal frame is designed into a diamond shape, so that the strength and the supporting force of the valve stent are improved, and the rupture of the annuloplasty ring caused by insufficient strength and supporting force is avoided.

Further, at least one barb type anchor 3 is obliquely arranged on the outer peripheral surface of the metal frame.

Further, the overhead hooks 3 are disposed at the vertices of the diamond-shaped mesh structure, and only one overhead hook is disposed at the vertices of the diamond-shaped mesh structure connected to each other.

Furthermore, the barb type anchoring piece is of a spike-shaped structure and is arranged in an inclined and downward mode along the direction from the left ventricle to the left atrium.

The barb-type anchoring piece is of a pointed structure, expands and expands under the action of external force, and is used for increasing friction and preventing the valve stent from falling off.

Further, the inclination angle of the inverted hook type anchor is 30-70 degrees.

Further, the length of the overhead hook type anchor is 1-3 mm.

Further, the metal frame also comprises a fabric layer wrapped inside the metal frame.

Further, the fabric layer comprises polyester and/or polytetrafluoroethylene.

Further, the valve support has a compressed configuration and a deployed configuration, the valve support is implanted into the body by means of the delivery device in the compressed configuration, and the implantation target position is switched to the deployed configuration so as to be fixed at the valve; in the deployed configuration, the support ring is in the left atrium and the metal frame is in the left ventricle, securing the valve stent with an inverted hook anchor.

In another embodiment, the present invention provides a method for implanting a valve stent, comprising the steps of:

the valve support is brought into a patient body through the conveying device, when the valve support is reached to a target position, the valve support is released, the valve support can be quickly unfolded from a contraction state, the forming ring unfolding process is more flexible due to the existence of the U-shaped structure, the forming ring is easy to fold, the support ring is located in the left atrium, the metal frame is located in the left ventricle, the support ring can be clamped by a mitral valve when the heart relaxes, the valve support is prevented from sliding down to the ventricle, and when the heart contracts, the valve support can be prevented from moving to the atrium due to the action of the inverted hook type anchoring piece.

In addition, when the connecting wire is divided into two strands, in the D-shaped section, the two strands of connecting wire intersect in an X shape, and the plane is cut into an 8 shape for supporting and intervening the mitral valve. Therefore, the valve stent provided by the invention can effectively prevent the valve stent from displacing under the pressure and scouring of blood flow after being released, prolongs the service life of the valve stent after being released, reduces the damage of the valve stent to surrounding tissues, has more flexible structure, and can provide positioning and support for the subsequent transcatheter mitral valve replacement valve.

In another embodiment, the present invention provides an interventional mitral valve replacement system comprising a valve stent as described in the first aspect.

Further, at least two interventional mitral valves are disposed within the valve stent.

Further, as shown in fig. 8, the interventional mitral valve comprises a strut frame 7; the edge of at least one side of the strut frame is provided with an annular flanging structure 6; at least three biological tissue valve leaflets 8 are arranged inside the strut frame 7, and the valve leaflets 8 are connected with the strut frame through fabric.

Wherein, the flanging structure 6 is at least arranged at the valve outflow side (namely one side of the strut frame 7) after being implanted in the body;

further, the flanging structures are arranged on two sides of the strut frame 7. The valve outflow side refers to the side where blood flows out of the valve, the metal frame at the end is provided with a flanging structure, the annuloplasty ring can be buckled from the left ventricle side in a reverse mode, and the valve is prevented from falling and shifting due to the pressure on the closed mitral valve outflow side during heart contraction.

The applicant declares that the above description is only a specific embodiment of the present invention, but the scope of the present invention is not limited thereto, and it should be understood by those skilled in the art that any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are within the scope and disclosure of the present invention.