CN214511422U - Mitral valve device - Google Patents

Abstract

The utility model relates to the technical field of medical equipment, in particular to a mitral valve device, which comprises a support and valve leaves, wherein the support comprises an outer support and an inner support, the outer support is flexibly connected by sewing a sewing film and comprises an outer expansion frame with the upper end used for being arranged at an atrium end, and a lower barrel-shaped frame which is used for receiving the upper end and extending the atrium end to a ventricle through an annulus, and one side of the outer expansion frame is provided with a highly convex atrium wall binding surface; the periphery of the barrel-shaped frame is provided with a plurality of convex structures close to the valve ring; the inner layer bracket is cylindrical, and the valve leaflets are sewed in the inner layer bracket through the clamping pieces; the tail end of the bracket is provided with a tightening structure, and the tightening structure is connected with an anchoring piece through a pull rope. The utility model discloses a mitral valve device and application method thereof, the anatomical structure of adaptation heart that can be better through double-deck supporting structure and asymmetric outer support reduces the influence of heart motion to inner support and valve leaflet, ensures device performance, extension device live time.

Description

Mitral valve device

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to a mitral valve device.

Background

The mitral valve is located between the left atrium and the left ventricle, and acts as a one-way valve to ensure that blood flows from the left atrium to the left ventricle and through a certain flow. The mitral valve complex is a complex set of devices that function and dissect structures, commonly thought of as including the annulus, leaflets, chordae tendinae, and papillary muscles. The function of the mitral valve depends on the integrity of its physiological structure. When the normal mitral valve is closed, the two valve leaflets are in the same plane and closely coapt, so that the backflow of the ventricular blood flow can be completely blocked. To achieve this result, the mitral annulus is required to be of a proper size, the leaflets have a complete structure, the papillary muscle contracts and pulls the chordae tendineae to support the leaflets, the left ventricular muscle contracts and generates a proper closing force, and the ventricles are required to have normal shapes and functions. Mitral regurgitation is triggered when damage occurs to the mitral valve complex structure or to the heart.

Transcatheter heart valve therapy offers physicians a new treatment with less trauma, fewer complications, and faster post-operative recovery as opposed to the surgical trauma, risk, and long-term and expensive post-operative recovery treatments of surgical valve replacement that discourage a large number of patients from undergoing surgery. Patent publication CN104302247A discloses a sequentially deployed prosthetic heart valve that includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. The first front ear is disposed on the front portion of the frame. The posterior tabs are located on the posterior portion of the self-expanding frame. The frame may be designed such that any portion can be sequentially expanded in any desired order. For example, a portion of the first anterior ear and a portion of the posterior ear may first partially self-expand. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may then be fully self-expanding, followed by ventricular skirt self-expansion; or the ventricular skirt may then self-expand, followed by full expansion of the posterior tab. Although this technical scheme can solve some technical problems of atrioventricular valve support manufacturing, because the particularity of mitral valve structure for the mitral valve intervenes the valve and puts into the difficulty and difficult fixed after putting into, still face a lot of problems in practical application, for example in valve normal position fixed problem, the valve is not enough with the anastomotic of heart physiology structure, produces the problem of valve week hourglass easily, to ventricle and the damage problem of structure under the valve, partial valve is oppressed by native tissue, influences the blood flow problem.

In view of the above technical problems, it is desirable to improve.

SUMMERY OF THE UTILITY MODEL

The utility model aims at providing a mitral valve device aiming at the defects of the prior art.

In order to realize the above purpose, the utility model adopts the following technical scheme:

a mitral valve device comprising a stent, leaflets, the stent comprising an outer stent and an inner stent; the surfaces of the outer layer bracket and the inner layer bracket are adhered with a sewing film, and the outer layer bracket and the inner layer bracket are flexibly connected by sewing the sewing film; the outer layer support comprises an external expanding frame with the upper end used for being placed at the atrium end, and a lower end barrel-shaped frame for receiving the upper end and extending the atrium end to the ventricle through the valve ring; the external expansion frame is provided with an inwards concave external expansion shape and is matched with the shape of the valve ring at the atrial end, one side of the external expansion frame is provided with an atrial wall binding surface with a raised height, and the atrial wall binding surface is matched with the shape of the atrial wall surface; a plurality of convex structures are arranged at the peripheral side of the barrel-shaped frame, which is close to the valve ring, and a clamping surface is formed between the convex structures and the outward-expanding frame; the inner layer support is cylindrical, and the valve leaflets are sewed in the inner layer support through the clamping pieces; the tail end of the bracket is provided with a tightening structure, and the tightening structure is connected with an anchoring piece through a pull rope.

Preferably, the external expanding frame and the barrel-shaped frame are provided with concave structures matched with the valve ring at the valve ring position where the external expanding frame and the barrel-shaped frame are accommodated.

Preferably, the included angle between the atrial wall attaching surface of the external expansion frame on the side close to the cardiac outflow tract and the horizontal plane is more than or equal to 30 degrees.

Preferably, the outer layer bracket and the inner layer bracket are net-shaped structures, and the net-shaped structures are formed by one or more of cutting, welding and weaving; the number of the grid layers of the external expansion frame and the barrel-shaped support in the inner support and the outer support is any one of a single layer or a plurality of layers, and the number of the grids in one layer of the grid layer is 3-30 grids.

Preferably, the number of the meshes of the outer expansion frame and the mesh layer of the barrel-shaped support in the inner support and the outer support is the same or different.

Preferably, the material of the stent is self-expandable memory alloy, and the wall thickness of the stent is 0.1-1 mm.

Preferably, the diameter of the external expanding frame is 20-120mm, and the height of the external expanding frame is 5-80 mm; the diameter of the barrel-shaped frame is 15-60mm, and the height of the barrel-shaped frame is 5-60 mm.

Preferably, the diameter of the inner layer bracket is 15-45mm, and the height of the inner layer bracket is 12-45 mm.

Preferably, the outer stent has a radiopaque indicator.

Preferably, the inner layer support is provided with an inner support suture hole, the valve leaf and the clamping piece are sewed on the inner layer support through the inner support suture hole, and the shape of the inner support suture hole is circular or polygonal.

Preferably, the valve leaf comprises a suture ear, a free edge and a suture edge, and the suture ear and the clip are sutured by a suture; the valve leaflet is made of biological materials and/or high polymer materials; the thickness of the valve leaf is 0.1-1 mm.

Preferably, the clamping pieces are provided with sewing holes, and the number of the sewing holes is 1-6; the clamping piece material is any one or more of a high polymer material, a biological material and a metal material.

Preferably, the suture film comprises an outer suture film, an inner suture film and a connecting film, the outer suture film is sutured on the outer side of the outer bracket through a suture line, the inner suture film is sutured on the inner side of the inner bracket through a suture line, and the connecting film is sutured on the inner upper part of the inner bracket from the inner upper part of the outer bracket through a suture line; the sewing membrane material is one or more of PET, polyurethane, PTFE and e-PTFE; the thickness of the stitching film is 0.01-1 mm.

Preferably, the suture thread diameter is 0.01-0.8 mm; the suture material is one or more of high polymer materials PET, PTFE, e-PTFE, biological tissues and tissue engineering materials.

Preferably, the tightening structure is connected with the bottom of the barrel-shaped frame of the outer layer bracket, the height of the tightening structure is 3-50mm, and the diameter of the tightened tightening structure is 1-10 mm.

Preferably, an auxiliary flexible connection and/or a rigid connection are/is further arranged between the outer-layer bracket and the inner-layer bracket to assist in fixing the outer-layer bracket and the inner-layer bracket.

Preferably, the number of the pull ropes is 1-20; the diameter of the pull rope is 0.05-4 mm; the pull rope is made of high polymer materials or biological tissues.

Preferably, the anchor is anchored outside the apex; the diameter of the anchoring piece is 3-30 mm; the thickness of the anchoring piece is 0.1-5 mm; the anchor material is one or more of a high polymer material, biological tissue and metal.

Preferably, the convex structure on the outer peripheral side of the barrel-shaped frame is an arc-shaped convex.

Compared with the prior art, the mitral valve device of the utility model reduces the influence of heart motion on the inner layer stent and the valve leaflets through the double-layer stent structure, ensures the device to exert efficiency and prolongs the service life of the device; in addition, the asymmetric outer-layer support can better adapt to the anatomical structure of the heart, perivalvular leakage is effectively reduced, the valve can be better fixed due to the protruding structure of the outer-layer support, the blood flowing obstruction is reduced due to the tightening structure, and the anchoring piece is firmly positioned.

Drawings

Fig. 1 is a schematic view of an overall structure of a mitral valve device according to a first embodiment of the present invention;

fig. 2 is a schematic structural view of an outer stent of a mitral valve device according to a first embodiment of the present invention;

fig. 3 is a schematic top view of an outer stent structure of a mitral valve device according to a first embodiment of the present invention;

fig. 4 is a schematic structural diagram of an inner stent of a mitral valve device according to a first embodiment of the present invention;

fig. 5 is a schematic top view of an inner stent structure of a mitral valve device according to a first embodiment of the present invention;

fig. 6 is a schematic structural view of an inner stent, a suture film and valve leaflets of a mitral valve device according to a first embodiment of the present invention;

fig. 7 is a schematic view of a clip structure of a mitral valve device according to a first embodiment of the present invention;

fig. 8 is a schematic structural view of an outer suture film of a mitral valve device according to a first embodiment of the present invention;

fig. 9 is a schematic structural view of an inner suture film of a mitral valve device according to a first embodiment of the present invention;

fig. 10 is a schematic structural view of a connecting membrane of a sewing membrane of a mitral valve device according to a first embodiment of the present invention;

fig. 11 is a schematic view of a leaflet structure of a mitral valve device according to a first embodiment of the present invention;

fig. 12 is a schematic view of a mitral valve device according to a first embodiment of the present invention after being implanted in a heart;

fig. 13 is a schematic view of a mitral valve device according to a first embodiment of the present invention;

fig. 14 is a schematic view of a mitral valve device according to an embodiment of the present invention;

fig. 15 is a schematic view of an outer stent structure of a mitral valve device according to an embodiment of the present invention;

fig. 16 is a schematic structural view of an inner stent of a mitral valve device according to a fourth embodiment of the present invention;

fig. 17 is a schematic view of an outer stent structure of a mitral valve device according to a fifth embodiment of the present invention;

fig. 18 is a schematic structural view of an anchor of a mitral valve device according to a sixth embodiment of the present invention;

fig. 19 is a schematic structural view of an anchor of a mitral valve device according to a sixth embodiment of the present invention;

fig. 20 is a schematic structural view of an anchor of a mitral valve device according to a sixth embodiment of the present invention;

wherein: 1. a mitral valve device; 2. an outer layer bracket; 2-1. extending the frame; 2-2. a barrel frame; 2-3, tightening the structure; 2-2-1. a convex structure; 3. an inner layer support; 3-1, sewing holes on the support; 4. a clip; 5. sewing the film; 5-1, externally sewing the membrane; 5-2, internally sewing the film; 5-3, connecting the membrane; 6. a leaflet; 6-1, sewing the ear; 6-2, sewing edges; 6-3, free edge; 7. pulling a rope; 8. an anchor.

Detailed Description

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The present invention can also be implemented or applied through other different specific embodiments, and various details in the present specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It is to be noted that the features in the following embodiments and examples may be combined with each other without conflict.

The first embodiment is as follows:

as shown in fig. 1 to 13, the mitral valve device 1 of the present embodiment includes a stent and leaflets 6, the stent includes an outer stent 2 and an inner stent 3, the outer stent 2 protects the inner stent 3 and restricts the movement of the valve in the heart after release; the surfaces of the outer layer bracket 2 and the inner layer bracket 3 are adhered with a sewing film 5, and the outer layer bracket 2 and the inner layer bracket 3 are flexibly connected by sewing the sewing film 5; the outer layer bracket 2 comprises an external expanding frame 2-1 with the upper end used for being arranged at the atrium end, and a lower end barrel-shaped frame 2-2 for receiving the upper end and extending the atrium end to the ventricle through the valve ring; the external expansion frame 2-1 is provided with an inwards concave external expansion shape, an inwards concave structure can be attached to the aorta surface and is matched with the shape of the atrium end close to the valve ring, one side of the external expansion frame 2-1 is provided with an atrium wall attaching surface which is highly convex, and the atrium wall attaching surface is matched with the atrium wall surface in shape; the periphery of the barrel-shaped frame 2-2 is provided with a plurality of convex structures 2-2-1 close to the valve ring, a clamping surface is formed between the convex structures 2-2-1 and the external expanding frame 2-1, the clamping surface can be matched with the whole outer layer bracket 2 to fix the device, the stability is enhanced, preferably, the convex structures 2-2-1 on the periphery of the barrel-shaped frame 2-2 are arc-shaped protrusions, the problem of damage to the ventricular valvular structure can be reduced, meanwhile, the internal structure can be plasticized, the compression of the valve membrane due to primary composition can be reduced, and the influence of blood flow can be reduced; the inner layer support 3 is cylindrical, and the valve leaflet 6 is sewed in the inner layer support 3 through the clamping piece 4 and used for replacing an in-situ valve; the tail end of the bracket is provided with a tightening structure 2-3, and the tightening structure 2-3 is connected with an anchoring piece 8 through a pull rope 7 for anchoring the bracket.

Specifically, the diameter of the external expanding frame 2-1 is 20-120mm, the height is 5-80mm, the diameter of the barrel-shaped frame 2-2 is 15-60mm, the height is 5-60mm, the size is more suitable for the structural size in the heart of a normal person, the external expanding frame 2-1 and the barrel-shaped frame 2-2 are provided with concave structures matched with valve rings at the valve ring bearing positions, and the concave structures are beneficial to the outer layer support 2 to be attached to a target position and reduce damage of abnormal mechanical force to the target area; furthermore, the included angle between the atrial wall binding surface on one side of the external expansion frame 2-1 close to the cardiac outflow tract and the horizontal plane is more than or equal to 30 degrees, the external asymmetrical support 2 can better adapt to the anatomical structure of the heart, the valve periphery leakage is effectively reduced, the atrial wall surface is more bound, the proper inclined angle can adapt to the pressure and the binding property of the atrial wall, and the stability is enhanced. Preferably, the outer stent 2 also has a radiopaque indicator to facilitate positioning of the device during surgery.

The diameter of the inner layer support 3 is 15-45mm, the height is 12-45mm, the inner layer support is more suitable for the size of a heart of a normal person, the inner layer support 3 is provided with inner support suture holes 3-1, the valve leaflet 6 and the clamping piece 4 penetrate through the inner support suture holes 3-1 to be sewn on the inner layer support 3, the shape of the inner support suture holes 3-1 is not limited, the inner support suture holes can be circular or polygonal, the clamping piece 4 is provided with matched suture holes, and the optimal number of the clamping pieces 4 is preferably 1-6; the clamping piece 4 is made of any one or more of polymer materials, biological materials and metal materials, and the clamping piece 4 can directly penetrate through the materials for sewing without sewing holes, so that the sealing performance is enhanced. The valve leaf 6 comprises a suture ear 6-1, a free edge 6-3 and a suture edge 6-2, and the suture ear 6-1 and the clamping piece 4 are sutured by suture; the valve leaflet 6 is made of biological materials and/or high polymer materials; the leaflet 6 is preferably 0.1-1mm thick for optimal strength and toughness.

The outer layer bracket 2 and the inner layer bracket 3 are both net structures, the net structures are formed by one or more modes of cutting, welding and weaving, the bracket material is self-expanding memory alloy, such as nickel titanium, nickel titanium base, copper base, iron base and other shape memory alloy, and when the wall thickness of the bracket is 0.1-1mm, the strength and toughness performance are optimal; the mesh shape is not limited to a square frame shape, a Z shape, a diamond shape, and the like; the number of the grid layers of the external expansion frame 2-1 and the barrel-shaped bracket in the inner bracket 3 and the outer bracket 2 can be single-layer or multi-layer, the number of the grid layers can be the same or different, the number of the grid layers or the number of the grid layers can also be the same or different, the number of the grid layers or the number of the grid layers is not limited, and the number of the grid layers of one layer is preferably 3-30, so that the manufacturing and using performance of the grid is optimal.

The sewing membrane 5 comprises an outer sewing membrane 5-1, an inner sewing membrane 5-2 and a connecting membrane 5-3, wherein the outer sewing membrane 5-1 is sewn on the outer side of the outer-layer support 2 through a sewing thread, the inner sewing membrane 5-2 is sewn on the inner side of the inner-layer support 3 through a sewing thread, and the connecting membrane 5-3 is sewn on the upper part of the inner side of the inner-layer support 3 from the upper part of the inner side of the outer-layer support 2 through a sewing thread; the sewing film 5 is made of one or more of PET, polyurethane, PTFE and e-PTFE; the thickness of the seaming film 5 is preferably 0.01-1mm for optimum strength and toughness. The diameter of the suture is preferably 0.01-0.8mm, and the use and manufacture performance is better; the suture material is one or more of high molecular material PET, PTFE, e-PTFE, biological tissue and tissue engineering material.

The tightening structure 2-3 is connected with the bottom of the barrel-shaped frame 2-2 of the outer layer support 2, the height of the tightening structure 2-3 is preferably 3-50mm, the diameter is set to be 1-10mm after tightening, the influence of the size on the internal structure of the heart is small, the tightening structure 2-3 can be in a net shape or a strip shape, and can be integrally woven, welded or woven and connected with the outer layer support 2, so that the obstruction of the artificial heart valve on blood entering an aorta can be reduced, and the turbulence can be reduced; the tightening structures 2-3 are connected with the anchoring piece 8 through pull ropes 7, the directions and the number of the pull ropes 7 are not limited, preferably, the number of the pull ropes 7 is 1-20, and the use applicability of the pull ropes 7 with the diameter of 0.05-4mm is strong; the pull rope 7 is made of high polymer material or biological tissue; the anchoring component 8 is anchored outside the apex of the heart by using a barb-shaped anchoring component, the diameter of the anchoring component 8 is preferably 3-30mm, the thickness is 0.1-5mm, the size is optimally adaptive, and the material is not limited to be one or more of high polymer material, biological tissue and metal.

In order to enhance the overall stability of the device after implantation, an auxiliary flexible connection and/or rigid connection is further arranged between the outer layer support 2 and the inner layer support 3 to assist in fixing the outer layer support 2 and the inner layer support 3, the flexible connection is connected with the inner layer support 3 in a bracing wire or a weaving manner, the rigid connection is formed by partially welding or riveting the lower end of the inner layer support 3 and the lower end of the barrel-shaped frame 2-2, the rigid connection of the flexible connection matching part can buffer the influence of heart beating on the work of the inner layer support 3 and the valve leaflet 6, the stability of the integrated device after implantation in the heart can be enhanced, the effectiveness is ensured, and the service life is prolonged.

When in use, the method comprises the following steps:

s1, the mitral valve device 1 is collected in the lumen of the delivery device and punctured to the apex of the heart or the atrium of the heart to the target position by the delivery device;

s2, releasing the outward-expanding frame 2-1 of the outer layer support 2 of the mitral valve device 1 delivered to the target position through the delivery device and pulling the delivery system of the delivery device to enable the outward-expanding frame 2-1 to cling to one side of the atrium of the valve;

s3, releasing the barrel-shaped frame 2-2 of the outer stent 2 so that the barrel-shaped frame 2-2 is tightly attached to the valve ring;

s4, releasing the tightening structure 2-3;

s5, the pulling rope 7 is pulled by the conveying device to adjust the positioning, namely when the releasing process encounters inaccurate positioning and needs to be repositioned, the pulling rope 7 can be used for sequentially pulling back the device structure to the conveying device and repositioning the device structure

S6, adjusting the length of the pull rope 7, releasing the anchor 8 when the pull rope reaches the apex of the heart and anchoring the anchor to the apex of the heart, wherein the anchor can be fixed in an embedding or suturing mode and can be positioned at a proper position such as the outer side of the apex of the heart;

s7, the transporter is removed.

The mitral valve device 1 and method of use of the present embodiment, with the apex anchor 8, can be securely positioned at a target location in the heart; the double-layer support structure can reduce the influence of heart motion on the inner-layer support 3 and the valve leaf 6, thereby ensuring the device to exert efficiency and prolonging the service time of the device; in addition, the asymmetric outer-layer support 2 can better adapt to the anatomical structure of the heart, and the perivalvular leakage is effectively reduced. The convex structure 2-2-1 of the outer layer bracket 2 can ensure that the valve is better fixed, and the tightening structure 2-3 can reduce the obstruction of the artificial heart valve on the blood entering the aorta.

Example two:

the mitral valve device of this example uses methods that differ from the embodiments in that:

as shown in fig. 14, the method comprises the following steps:

s1, the mitral valve device is collected in the lumen of the delivery device and enters the left atrium through the delivery device via the blood vessel or the right atrium;

s2, reaching the apex of the heart, releasing the anchor through the delivery device and anchoring the anchor to the apex of the heart;

s3, releasing the pull rope, adjusting the length of the pull rope and tensioning the pull rope;

s4, sequentially releasing the tightening structure, the barrel-shaped frame and the outward-expanding frame to a target position;

s5, the transporter is removed.

Compared with the first embodiment, the conveying path of the conveying device is not limited, and the universality of the device is stronger.

Other structures refer to the first embodiment.

Example three:

the mitral valve device of this embodiment differs from the first embodiment in that:

as shown in fig. 15, the constriction structure of the present embodiment has a small constriction opening and performs incomplete constriction, and thus can improve the toughness of the device and further reduce the blood flow resistance as compared with the first embodiment.

Other structures refer to the first embodiment.

Example four:

the mitral valve device of this embodiment differs from the first embodiment in that:

as shown in fig. 16, the tightening structure of the present embodiment is connected to the bottom of the inner stent, and compared with the first embodiment, the design can reduce the stretching effect on the outer stent during the cardiac motion, and enhance the implantation stability of the device. Preferably, the connection of the tightening structure and the inner layer bracket or the outer layer bracket is provided with a radian, so that the damage to the inner structure of the heart is avoided.

Other structures refer to the first embodiment.

Example five:

the mitral valve device of the present embodiment differs from the first embodiment in that:

as shown in fig. 17, the protruding structure on the peripheral side of the outer layer stent barrel-shaped frame in this embodiment is in a barb shape, compared with the first embodiment, the shape of the protruding structure on the peripheral side is not limited, the barb-shaped protrusion can penetrate into the target position to further stabilize the device while forming the clamping surface, and the protruding structure may also be an arc protrusion, a combination of barb-shaped protrusions, or other shapes capable of forming the clamping surface, such as a straight strip shape.

Other structures refer to the first embodiment.

Example six:

the mitral valve device of the present embodiment differs from the first embodiment in that:

as shown in fig. 18-20, the anchor of the present example may be a threaded anchor, a washer anchor, or a washer and barb combined anchor, which is more convenient to anchor and release after implantation than the first embodiment without limiting the form of the anchor; the gasket anchoring piece can be arranged outside the apex of the heart and can adjust the length of the pull rope; the gasket and the barb combined anchor, the gasket can be placed outside the apex of the heart, and the barb is placed in the myocardium, so that the anchoring effect is enhanced.

Other structures refer to the first embodiment.

The specific embodiments described herein are merely illustrative of the spirit of the invention. Various modifications, additions and substitutions for the specific embodiments described herein may be made by those skilled in the art without departing from the spirit of the invention or exceeding the scope of the invention as defined in the accompanying claims.

Claims (19)

1. A mitral valve device comprises a stent and valve leaflets, and is characterized in that the stent comprises an outer stent and an inner stent; the surfaces of the outer layer bracket and the inner layer bracket are adhered with a sewing film, and the outer layer bracket and the inner layer bracket are flexibly connected by sewing the sewing film; the outer layer support comprises an external expanding frame with the upper end used for being placed at the atrium end, and a lower end barrel-shaped frame for receiving the upper end and extending the atrium end to the ventricle through the valve ring; the external expansion frame is provided with an inwards concave external expansion shape and is matched with the shape of the valve ring at the atrial end, one side of the external expansion frame is provided with an atrial wall binding surface with a raised height, and the atrial wall binding surface is matched with the shape of the atrial wall surface; a plurality of convex structures are arranged at the peripheral side of the barrel-shaped frame, which is close to the valve ring, and a clamping surface is formed between the convex structures and the outward-expanding frame; the inner layer support is cylindrical, and the valve leaflets are sewed in the inner layer support through the clamping pieces; the tail end of the bracket is provided with a tightening structure, and the tightening structure is connected with an anchoring piece through a pull rope.

2. The mitral valve device of claim 1, wherein the flaring frame and barrel frame have an internal concave structure that fits the annulus at the location of the receiving annulus.

3. The mitral valve device of claim 2, wherein the atrial wall abutment surface of the flaring frame is at an angle greater than or equal to 30 degrees to the horizontal.

4. The mitral valve device of claim 3, wherein the outer stent and the inner stent are mesh structures formed by one or more of cutting, welding, and weaving; the number of the grid layers of the external expansion frame and the barrel-shaped support in the inner support and the outer support is any one of a single layer or a plurality of layers, and the number of the grids in one layer of the grid layer is 3-30 grids.

5. The mitral valve device of claim 4, wherein the mesh layers of the outer frame and the barrel-shaped stent in the inner stent and the outer stent have the same or different number of meshes.

6. The mitral valve device of claim 1, wherein the stent is made of a self-expandable memory alloy, and the stent has a wall thickness of 0.1-1 mm.

7. The mitral valve device of claim 1, wherein the flaring frame has a diameter of 20-120mm and a height of 5-80 mm; the diameter of the barrel-shaped frame is 15-60mm, and the height of the barrel-shaped frame is 5-60 mm.

8. The mitral valve device of claim 1, wherein the inner stent has a diameter of 15-45mm and a height of 12-45 mm.

9. The mitral valve device of claim 1, wherein the outer stent has a radiopaque indicator.

10. The mitral valve device of claim 1, wherein the inner stent has inner stent suture holes through which the leaflets and clips are sutured to the inner stent, and the inner stent suture holes are circular or polygonal in shape.

11. The mitral valve device of claim 1, wherein the leaflets comprise a suture ear, a free edge, and a suture edge, and the suture ear and the clip are sutured with a suture thread; the valve leaflet is made of biological materials and/or high polymer materials; the thickness of the valve leaf is 0.1-1 mm.

12. The mitral valve device of claim 11, wherein the clip has suture holes in a number of 1-6; the clamping piece material is any one or more of a high polymer material, a biological material and a metal material.

13. The mitral valve device of claim 1, wherein the suture films comprise an outer suture film, an inner suture film, and a connecting film, the outer suture film is sutured to the outside of the outer stent by sutures, the inner suture film is sutured to the inside of the inner stent by sutures, and the connecting film is sutured to the inside upper portion of the inner stent by sutures from the inside upper portion of the outer stent; the sewing membrane material is one or more of PET, polyurethane, PTFE and e-PTFE; the thickness of the stitching film is 0.01-1 mm.

14. The mitral valve device of claim 13, wherein the suture is 0.01-0.8mm in diameter; the suture material is one or more of high polymer materials PET, PTFE, e-PTFE, biological tissues and tissue engineering materials.

15. The mitral valve device of claim 14, wherein the tightening structure is connected to the bottom of the barrel frame of the outer stent, and has a height of 3-50mm and a diameter of 1-10mm after tightening.

16. The mitral valve device of claim 15, wherein the outer stent and the inner stent further comprise auxiliary flexible and/or rigid connections therebetween to assist in securing the outer stent and the inner stent.

17. The mitral valve device of claim 15, wherein the number of pull cords is 1-20; the diameter of the pull rope is 0.05-4 mm; the pull rope is made of high polymer materials or biological tissues.

18. The mitral valve device of claim 1, wherein the anchor is anchored outside the apex of the heart; the diameter of the anchoring piece is 3-30 mm; the thickness of the anchoring piece is 0.1-5 mm; the anchor material is one or more of a high polymer material, biological tissue and metal.

19. The mitral valve device of claim 1, wherein the peripheral side projection structures of the barrel frame are arcuate projections.

Images