阅读说明：本技术 经导管植入的二尖瓣瓣膜装置 (Transcatheter implanted mitral valve device ) 是由 梁玉晨 彭骏 张新页 于 2021-09-27 设计创作，主要内容包括：本发明属于医疗器械技术领域,具体涉及一种二尖瓣瓣膜装置。一种经导管植入的二尖瓣瓣膜装置,包括：一支架机构,具有一外层支架、与外层支架连接的内层支架；一瓣叶机构,位于内层支架内；内层支架自近端向远端依次包括：牵引部,近端呈收束状；第一连接部,呈中空柱状结构且与瓣叶机构连接,近端与牵引部连接；外层支架自近端向远端依次包括：第二连接部,与牵引部的远端连接,近端向内部收拢,第二连接部的近端被牵引部的近端伸出；支撑部,呈中空类柱状结构,内部架空设置有第一连接部。本发明内层支架和外层支架之间为架空结构,有效避免了心脏运动对瓣叶的影响。(The invention belongs to the technical field of medical instruments, and particularly relates to a mitral valve device. A transcatheter implanted mitral valve device, comprising: the support mechanism is provided with an outer support and an inner support connected with the outer support; a valve leaf mechanism positioned in the inner layer bracket; the inlayer support includes from the near-end to the distal end in proper order: a traction part, the near end of which is in a contraction shape; the first connecting part is in a hollow columnar structure and is connected with the valve leaflet mechanism, and the near end of the first connecting part is connected with the traction part; outer support includes from the near-end to the distal end in proper order: the second connecting part is connected with the far end of the traction part, the near end of the second connecting part is folded inwards, and the near end of the second connecting part is extended out of the near end of the traction part; the supporting part is a hollow columnar structure, and a first connecting part is arranged in the supporting part in an overhead mode. The inner layer bracket and the outer layer bracket of the invention are in an overhead structure, thereby effectively avoiding the influence of heart motion on the valve leaflet.)

1. A transcatheter implanted mitral valve device, comprising:

the support mechanism is provided with an outer support and an inner support connected with the outer support;

a leaflet mechanism located within the inner stent;

it is characterized in that the inner layer bracket sequentially comprises from the near end to the far end:

a traction part, the near end of which is in a contraction shape;

the first connecting part is of a hollow columnar structure and is connected with the valve leaflet mechanism, and the near end of the first connecting part is connected with the traction part;

the outer layer support includes from near-end to distal end in proper order:

the second connecting part is connected with the far end of the traction part, the near end of the second connecting part is folded inwards, and the near end of the second connecting part is extended out of the near end of the traction part;

a supporting part which is a hollow columnar structure and is provided with the first connecting part in an overhead manner.

2. The transcatheter implanted mitral valve device of claim 1, wherein a side of a longitudinal cross-section of the support portion includes an angle of 5 ° -15 ° with a central axis of the inner stent;

the cross section of the supporting part is of a D-shaped structure so as to be matched with the native mitral valve annulus;

the chord length of the cross section of the supporting part passing through the central point is larger than the maximum outer diameter of the first connecting part;

the proximal end of the second connecting part is folded inwards through an inwards bent structure, and the bending angle of the inwards bent structure is the same as that of the distal end of the traction part.

3. The transcatheter implanted mitral valve device of claim 1, wherein the outer stent further comprises, from a proximal end to a distal end:

the joint part is of a round table structure, the near end of the joint part is connected with the far end of the supporting part, the round table structure expands outwards from the near end to the far end, and the minimum inner diameter of the joint part is larger than the maximum outer diameter of the first connecting part;

and the near end of the condensation part is connected with the far end of the fitting part, and the far end is folded inwards.

4. The transcatheter implanted mitral valve device of claim 3, wherein a generatrix of the fit portion forms an angle with a central axis of the fit portion of not less than 20 °;

the included angle between the furling surface at the far end of the condensation part and the bus of the attaching part is not less than 15 degrees.

5. The transcatheter implanted mitral valve device of claim 1, wherein the inner stent further comprises:

and the guide part is connected with the far end of the first connecting part and extends to the far end along the axial direction of the inner layer bracket.

6. The transcatheter implanted mitral valve device of claim 1, wherein the outer stent and the inner stent are each compressible mesh structures, and are each made of a self-expanding material or a memory alloy.

7. The transcatheter implanted mitral valve device of claim 5, wherein the leaflet mechanism comprises a plurality of leaflets, the plurality of leaflets are sequentially connected to form a valve body with an outer circumference of a ring structure, the valve body is fixedly connected with the inner side wall of the first connecting part, and the middle part of the valve body can be opened and closed in one direction.

8. The transcatheter implanted mitral valve device of claim 7, wherein each of the leaflets comprises:

the outer side of the valve leaflet tail part is of a protruding structure, and the outer side edge of the protruding structure is connected with the inner side wall of the inner-layer bracket;

the outer side of the sealing strip is connected with the inner side of the valve leaflet tail part, the side surface where the inner side is located is perpendicular to the plane where the valve leaflet tail part is located, the other two opposite side surfaces of the sealing strip are respectively provided with a fixed end, the fixed ends are turned over and wrapped with clamping pieces to form a fixed part, and the fixed part is fixedly connected with the first connecting part;

two adjacent valve leaflets are sequentially connected through the fixing piece to form the valve body, and the end parts of the inner side surfaces of the sealing strips in the two adjacent valve leaflets are contacted to realize that the middle parts of the valve body can be opened and closed in a one-way mode.

9. The transcatheter implanted mitral valve device of claim 8, further comprising:

the sewing film wraps the support mechanism and is connected with the valve leaf mechanism;

the sewing film includes:

the outer sewing film is fixed on the outer side of the outer layer bracket;

the inner sewing film is fixed on the inner side of the inner layer bracket and the inner side of the outer sewing film;

a seam film connected to distal ends of the outer and inner seam films;

the leaflet sewing film is fixed on the outer side edge of the leaflet tail part, and the leaflet tail part is connected with the inner side wall of the inner layer bracket by the fixed connection of the leaflet sewing film and the inner sewing film;

the far end of the traction part and the second connecting part are both provided with mutually matched bracket sewing holes, and the inner bracket and the outer bracket are connected through the bracket sewing holes;

the first connecting part is provided with a valve leaflet sewing hole, and the inner layer support and the valve leaflet mechanism are connected through the valve leaflet sewing hole;

the distal end of guide part is equipped with the tectorial membrane and sews up the hole, the surface of guide part is equipped with guide part seam membrane, the near-end of guide part seam membrane is the sawtooth structure, the sawtooth structure with leaflet seam hole on the first connecting portion with the support seam hole on the traction portion all wraps up in.

10. The transcatheter implanted mitral valve device of any one of claims 1 to 9, wherein a proximal end of the traction portion is provided with a traction suture hole;

the mitral valve device further comprises:

one end of the traction rope is fixedly connected with the traction suture hole of the traction part;

and the anchoring piece is connected with the other end of the traction rope, and the mitral valve device is fixed on the apex of the heart by the anchoring piece.

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates 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 blood flow from the left atrium to the left ventricle. When the normal mitral valve is closed, the two valve leaflets are in the same plane and closely involuted, and ventricular blood can be completely prevented from flowing back to the atrium. However, when the mitral valve complex structure is damaged or the heart is damaged, mitral regurgitation is caused.

At present, the mode of treating mitral regurgitation through operations mainly comprises two types of surgical open chest operations and medical minimally invasive operations. The surgical chest-opening operation causes a large amount of patients to be reluctant to accept the treatment mode due to large operation trauma, high risk and long-term and expensive rehabilitation after the operation, and the internal minimally invasive operation of the transcatheter heart valve treatment provides a novel treatment method which has smaller trauma, less complication and quick postoperative rehabilitation for doctors. Chinese invention patent application no: 202011439539.9, title of the invention: the patent discloses a mitral valve device and a using method thereof, and the mitral valve device and the using method thereof well solve the problem of valve leakage by improving the shape and the structure of an outer layer bracket, but the mitral valve device is found to have the phenomenon of mitral regurgitation in the process of heart shaking in clinical experiments. The main reason for this kind of regurgitation phenomenon is because the supporting part department that receives heart extrusion is as the tie point for inlayer support and outer support, and heart extrusion in-process, inlayer support also can take place deformation, and the closed not tight condition probably appears in the influence of deformation in the good leaflet of original cooperation to lead to regurgitation phenomenon's emergence.

Disclosure of Invention

The invention aims to solve the technical problem that the existing mitral valve device has the phenomenon of mitral regurgitation due to the structural defects, and aims to provide a mitral valve device implanted through a catheter.

A transcatheter implanted mitral valve device, comprising:

the support mechanism is provided with an outer support and an inner support connected with the outer support;

a leaflet mechanism located within the inner stent;

the inner layer support sequentially comprises from the near end to the far end:

a traction part, the near end of which is in a contraction shape;

the first connecting part is of a hollow columnar structure and is connected with the valve leaflet mechanism, and the near end of the first connecting part is connected with the traction part;

the outer layer support includes from near-end to distal end in proper order:

the second connecting part is connected with the far end of the traction part, the near end of the second connecting part is folded inwards, and the near end of the second connecting part is extended out of the near end of the traction part;

a supporting part which is a hollow columnar structure and is provided with the first connecting part in an overhead manner.

The valve leaflet loading device realizes connection through the far end of the first connecting part and the valve leaflet mechanism on the inner side of the first connecting part, and achieves the aim of loading the valve leaflets on the inner-layer support. The supporting part of the outer layer bracket is used for extruding the atrial wall and is fixedly connected with the atrial wall. Realize connecting through the distal end of second connecting portion and traction portion between outer support and the inlayer support, and adopt overhead structure between the supporting part of outer support and the first connecting portion of inlayer support, when outer support receives the extrusion, the deformation does not take place for the first connecting portion of inlayer support, and the valve leaflet mechanism of connection in first connecting portion can keep encapsulated situation, has effectively avoided the influence of heart motion to the valve leaflet.

An included angle between one side edge of the longitudinal section of the supporting part and the central shaft of the inner layer bracket is 5-15 degrees.

The support portion preferably has a D-shaped cross-section to fit the native mitral annulus.

The chord length of the cross section of the supporting part passing through the central point is larger than the maximum outer diameter of the first connecting part.

The proximal end of the second connecting part is folded inwards through an inwards bent structure, and the bending angle of the inwards bent structure is the same as that of the distal end of the traction part.

The outer stent further comprises from the proximal end to the distal end:

the joint part is of a round table structure, the near end of the joint part is connected with the far end of the supporting part, the round table structure expands outwards from the near end to the far end, and the minimum inner diameter of the joint part is larger than the maximum outer diameter of the first connecting part;

and the near end of the condensation part is connected with the far end of the fitting part, and the far end is folded inwards.

The included angle between the generatrix of the attaching part and the central axis of the attaching part is not less than 20 degrees.

The included angle between the furling surface at the far end of the condensation part and the bus of the attaching part is not less than 15 degrees.

The inner stent further comprises:

and the guide part is connected with the far end of the first connecting part and extends to the far end along the axial direction of the inner layer bracket.

The outer layer stent and the inner layer stent are both compressible net structures and are made of self-expanding materials or memory alloys such as nickel-titanium alloy and the like.

The valve leaflet mechanism comprises a plurality of valve leaflets, the valve leaflets are sequentially connected to form a valve body with an outer circumference of a circular ring structure, the valve body is fixedly connected with the inner side wall of the first connecting part, and the middle of the valve body can be opened and closed in a one-way mode.

Each of the leaflets comprises:

the outer side of the valve leaflet tail part is of a protruding structure, and the outer side edge of the protruding structure is connected with the inner side wall of the inner-layer bracket;

the outer side of the sealing strip is connected with the inner side of the valve leaflet tail part, the side surface where the inner side is located is perpendicular to the plane where the valve leaflet tail part is located, the other two opposite side surfaces of the sealing strip are respectively provided with a fixed end, the fixed ends are turned over and wrapped with clamping pieces to form a fixed part, and the fixed part is fixedly connected with the first connecting part;

two adjacent valve leaflets are sequentially connected through the fixing piece to form the valve body, and the end parts of the inner side surfaces of the sealing strips in the two adjacent valve leaflets are contacted to realize that the middle parts of the valve body can be opened and closed in a one-way mode.

The mitral valve device further comprises:

and the sewing film wraps the support mechanism and is connected with the valve leaf mechanism.

The sewing film includes:

the outer sewing film is fixed on the outer side of the outer layer bracket;

the inner sewing film is fixed on the inner side of the inner layer bracket and the inner side of the outer sewing film;

a seam film connected to distal ends of the outer and inner seam films;

the leaflet sewing film is fixed on the outer side edge of the leaflet tail, and the leaflet tail is connected with the inner side wall of the inner layer bracket through the fixed connection of the leaflet sewing film and the inner sewing film.

The far end of the traction part and the second connecting part are both provided with mutually matched bracket sewing holes, and the inner bracket and the outer bracket are connected through the bracket sewing holes;

the inner layer support is connected with the valve leaflet mechanism through the valve leaflet sewing hole.

The distal end of guide part is equipped with the tectorial membrane and sews up the hole, the surface of guide part is equipped with guide part seam membrane, the near-end of guide part seam membrane is the sawtooth structure, the sawtooth structure with leaflet seam hole on the first connecting portion with the support seam hole on the traction portion all wraps up in.

The proximal end of the traction part is provided with a traction suture hole;

the mitral valve device further comprises:

one end of the traction rope is fixedly connected with the traction suture hole of the traction part;

and the anchoring piece is connected with the other end of the traction rope, and the mitral valve device is fixed on the apex of the heart by the anchoring piece.

The positive progress effects of the invention are as follows: the invention adopts a mitral valve device implanted by a catheter, and has the following remarkable advantages:

1. an overhead structure is arranged between the inner layer bracket and the outer layer bracket, so that the influence of heart motion on the valve leaflets is effectively avoided;

2. the upper portion of outer support sets up laminating portion, more laminates the upper portion of atrium wall under the prerequisite that does not bear pressure, prevents that the valve is all around leaked.

3. The valve leaflet mechanism formed by the independent valve leaflets has a valve leaflet structure with a function similar to a one-way valve, and the structure is more stable and reliable;

4. the suture film wraps the stent mechanism, so that endothelialization can be effectively promoted.

Drawings

FIG. 1 is a schematic view of an overall structure of the present invention;

FIG. 2 is a schematic structural diagram of the support mechanism of the present invention;

FIG. 3 is a top view of FIG. 2;

FIG. 4 is a schematic structural view of an inner stent of the present invention;

FIG. 5 is a top view of FIG. 4;

FIG. 6 is a schematic view of an outer stent of the present invention;

FIG. 7 is a top view of FIG. 6;

fig. 8 is a schematic view of a leaflet mechanism of the present invention;

fig. 9 is a schematic view of a single leaflet of the present invention;

FIG. 10 is a schematic view of a clip according to the present invention;

fig. 11 is a schematic view of the relative positions of the clip and leaflet of the present invention;

FIG. 12 is a schematic view of a portion of the construction of an outer seam film of the present invention;

FIG. 13 is a schematic structural view of another portion of an outer seam film of the present invention;

FIG. 14 is a schematic view of a construction of an internal sewing film of the present invention;

FIG. 15 is a schematic view of a structure for joining the seam films;

FIG. 16 is a schematic diagram of an application of the present invention.

Detailed Description

In order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, the invention is further described with the specific drawings.

Referring to fig. 1 to 16, a transcatheter implanted mitral valve device includes a stent mechanism 100, a leaflet mechanism 200, a suture film 300, a pull-cord 400, and an anchor 500.

Referring to fig. 2 and 3, the stent mechanism 100 includes an inner stent 110 and an outer stent 120, which are connected by a suture through stent suture holes on an inner bent structure having the same bending angle. The inner stent 110 and the outer stent 120 are both compressible mesh structures, and are made of self-expanding materials or memory alloys, such as nitinol.

Referring to fig. 4 and 5, the inner stent 110 includes a traction portion 111, a first connection portion 112, and a guide portion 113 in this order from a proximal end to a distal end.

The proximal end of the traction part 111 is in a contracted shape, the proximal end of the traction part 111 extends out of the proximal end of the outer layer support 120, and the proximal end of the traction part 111 is provided with a traction suture hole 1111 for fixedly connecting with the traction rope 400. The distal end of the traction portion 111 is provided with a stent suture hole 1112 for connecting with the outer stent 120.

The proximal end of the first connection portion 112 is connected to the distal end of the traction portion 111. The distal end of the first connecting portion 112 is a hollow cylindrical structure and is connected to the leaflet mechanism 200. At the distal end of the first connection portion 112, a leaflet suture hole 1121 is provided for connection with the leaflet mechanism 200.

The proximal end of the guide portion 113 is connected to the distal end of the first connecting portion 112, and the guide portion 113 extends distally in the axial direction of the inner stent 110. A film-covering suture hole 1131 is provided at the distal end of the guide 113 for suturing the guide to suture the film. Guide portion 113 is an optional structure, and guide portion 113 may facilitate crimping of the mitral valve device for delivery. After the guiding part 113 is provided at the distal end of the inner stent 110, as shown in fig. 4, the inner stent 110 may be connected by surrounding a plurality of Y-shaped stents to obtain a stable stent structure.

Referring to fig. 6 and 7, the outer stent 120 includes a second connecting portion 121, a supporting portion 122, a fitting portion 123, and a condensing portion 124 in this order from the proximal end to the distal end.

The proximal end of the second connecting portion 121 is inwardly folded, the proximal end of the second connecting portion 121 is extended by the proximal end of the traction portion, and the second connecting portion 121 is provided with a stent suture hole 1211 for connecting with the distal end of the traction portion 111. As shown in fig. 6, the proximal end of the second connecting portion 121 is inwardly folded by an inwardly bent structure having the same bending angle as the distal end of the traction portion 111 in fig. 4, so that the second connecting portion 121 and the traction portion 111 are completely attached to each other, and the outer stent 120 and the inner stent 110 are fixed by suture between the stent suture hole 1211 and the stent suture hole 1112. The bending angle is preferably 10 ° or more.

The supporting portion 122 is connected to the distal end of the second connecting portion 121, and the supporting portion 122 is a hollow column-like structure, preferably having a D-shaped cross section, for fitting the native mitral valve annulus. The first connecting portion 112 is disposed in the supporting portion 122 in an overhead manner, and a chord length of the cross section of the supporting portion 122 passing through a center point is larger than a maximum outer diameter of the first connecting portion 112. Preferably, the other components of the inner bracket 110 are suspended in the outer bracket 120, i.e., are not in direct contact with the outer bracket 120, except for the connection between the second connecting portion 121 and the pulling portion 111. One side of the longitudinal section of the supporting portion 122 forms an angle of 5 to 15 degrees with the central axis of the inner bracket 110, that is, as shown in fig. 2, the inner bracket 110 is not completely located in the middle of the outer bracket 120.

The fitting part 123 is connected with the distal end of the supporting part 122, the fitting part 123 is a circular truncated cone structure expanding from the proximal end to the distal end, and the minimum inner diameter of the fitting part 123 is larger than the maximum outer diameter of the first connecting part 112, so that the other parts of the inner bracket 110 except the traction part 111 are all suspended in the outer bracket 120. As shown in fig. 6, an angle a between a generatrix of the attaching portion 123 and a central axis of the attaching portion 123 is not less than 20 °. Set up laminating portion 123 at the distal end of outer layer support, the upper portion of more laminating atrium wall under the prerequisite that does not bear pressure can effectively prevent the perivalvular leakage.

The condensation part 124 is connected with the far end of the fitting part 123, the far end of the condensation part 124 is folded inwards, and the height of the far end of the condensation part 124 is higher than that of the far end of the inner bracket 110, so that the inner bracket 110 is folded in the outer bracket 120 in an overhead manner. The included angle b between the converging surface of the far end of the condensation part 124 and the generatrix of the fitting part 123 is not less than 15 degrees.

Referring to fig. 8, the leaflet mechanism 200 is positioned within the inner stent 110. The leaflet mechanism 200 includes a plurality of leaflets 210, the plurality of leaflets 210 are sequentially connected to form a valve body with an outer circumference of a circular ring structure, the valve body is fixedly connected with the inner side wall of the first connecting portion 112, and the middle of the valve body can be opened and closed in one direction. As shown in fig. 8, the leaflet mechanism 200 preferably includes three independent leaflets 210, and a valve body with a circular ring structure enclosed by the three leaflets 210 has a function similar to a "one-way valve".

Each leaflet 210 includes a leaflet tail 211, a sealing strip 212, and a securing member 213. The outer side of the leaflet tails 211 is a ledge structure, and the outer side edge of the ledge structure is connected to the inner side wall of the inner stent 110. The sealing strip 212 is of a bent structure, the outer side of the sealing strip 212 is connected with the inner side of the leaflet tail 211, the side where the inner side of the sealing strip 212 is located is perpendicular to the plane where the leaflet tail 211 is located, the other two opposite sides of the sealing strip 212 are respectively provided with a fixed end 2121, the fixed end 2121 is folded and wrapped with a clip 214 to form a fixing part 213, and the fixing part 213 is fixedly connected with the first connecting part 112 through the fixing part 213. As shown in fig. 9, the leaflet 210 is shown in an unfolded state with the sealing strip 212, and fixing ends 2121 are formed by extending outward from both left and right sides of the sealing strip 212. As shown in fig. 10, the thickness of the clip 214 is preferably 0.1 mm to 0.5 mm, and at least one clip sewing hole 2141 is formed on the clip 214, and the fixing end 2121 is sewn through the clip sewing hole 2141 and wraps the clip 214.

Referring to fig. 11, two adjacent leaflets 210 are connected in sequence by a fixing member 213 through a clip suture hole 2141 by suture, and the inner side ends of the sealing strips 212 in the two adjacent leaflets 210 are contacted to realize that the middle of the valve body can be opened and closed in one direction. When the leaflet mechanism 200 is fixedly connected to the first connecting portion 112 by the fixing member 213, the leaflet mechanism 200 is also fixed to the inner holder 110 in the blood flow direction by sewing with a suture thread through the clip sewing hole 2141 and the leaflet sewing hole 1121 of the first connecting portion 112. Although the native valve is a mitral valve, in consideration of structural stability, the mitral valve device designed by the present invention is designed into a plurality of leaflets 210, the plurality of leaflets 210 are fixed by clips 214 to form fixing members 213, and then are sutured into the inner stent 110, so that the strength and stability of the axial leaflets 210 of the leaflet mechanism 200 are enhanced, the point contact of the leaflets 210 with the inner stent 110 is changed into line contact, and the tension of the local leaflets 210, especially the distal leaflets 210 during blood flow is reduced, so that the structure is more stable. The longitudinal sewing mode ensures the function of a one-way valve and effectively improves the bearing capacity of the one-way valve to reverse pressure.

The suture film 300 wraps around the stent mechanism 100, and the stent mechanism 100 is connected to the leaflet mechanism 200 by the suture film 300. The design of the sewing membrane 300 is effective in promoting endothelialization.

Referring to fig. 12 to 15, the sewing film 300 includes an outer sewing film, an inner sewing film, a connecting sewing film, a leaflet sewing film, and a guide portion sewing film.

The outer suture film is fixed to the outer side of the outer stent 120, and the outer suture film of the present invention may be divided into an upper outer suture film 311 and a lower outer suture film 312 according to the specific structure of the outer stent 120. The upper outer seam film 311 is constructed as shown in fig. 12, and the upper outer seam film 311 may be sewn to the upper portion of the outer layer frame 120, for example, to the outside of the attachment portion 123 and the condensation portion 124. The lower outer seam film 312 is constructed as shown in FIG. 13, and the lower outer seam film 312 is sewn to the lower portion of the outer layer stent 120, for example, the second connecting portion 121 and the outer side of the supporting portion 122, and the stent seam hole 1211 is sewn with a sewing thread.

The inner suture film is fixed to the inner side of the inner layer support 110 and the inner side of the outer suture film. As shown in fig. 14, the inner suture film 320 has a zigzag structure at the proximal end of the inner suture film 320, and the inner suture film 320 can be sutured inside the inner layer stent 110 through the stent suture holes 1112, the leaflet suture holes 1121, and the covering film suture holes 1131.

The connecting seaming film is connected to distal ends of the outer and inner seaming films. An attachment suture film 330, as shown in fig. 15, may be attached to the distal ends of the outer and inner suture films by distal film-covering suture holes 1131 and sutures, such that all of the suture films 300 together form a closed whole.

The leaflet sewing film is fixed on the outer side edge of the leaflet tail 211, and the connection of the leaflet tail 211 and the inner side wall of the inner bracket 110 is realized by the suture fixing connection of the leaflet sewing film and the inner sewing film through the suture. As shown in fig. 8 and 9, the outer edges of the leaflet tails 211 are coated with a leaflet sewing film 330, and the leaflet sewing film 330 and the inner sewing film 320 are fixedly connected by sewing.

The proximal end of the guide portion suture film is in a sawtooth structure, the guide portion suture film is arranged on the outer surface of the guide portion 113, the distal end of the guide portion suture film is sutured on the distal outer surface of the inner layer support 110 through the film suture hole 1131 and the suture line, and the proximal end of the guide portion suture film is sutured on the proximal outer surface of the inner layer support 110 through the leaflet suture hole 1121, the support suture hole 1112 and the suture line. The saw tooth structure of the guide sewing membrane wraps both the stent sewing hole 1112 and the first connection portion 112.

Referring to fig. 1, one end of a traction rope 400 is fixedly coupled to the traction suture hole 1111 of the traction part 111. The other end of the pull-cord 400 is attached to an anchor 500.

The pulling rope 400 is composed of a single rope or a plurality of ropes, the pulling rope 400 is fixed on the pulling suture hole 1111 at the near end of the pulling part 111 of the inner layer support 110 in a winding and suture mode, and the near end of the inner layer support 110 is contracted into a compact structure, and the total diameter is less than or equal to 2 mm.

The anchor 500 is provided with a through hole allowing the pull rope 400 to freely pass through in an unlocked condition, the anchor 500 is provided with a fixing device at the side opposite to the center apex, the pull rope 400 can be locked by means of suturing, binding or mechanical constraint and the like when needed, so that the anchor 500 cannot move in the through hole, the diameter of the anchor 500 is preferably 10 mm-30 mm, and the thickness of the anchor is preferably 0.1 mm-5 mm.

As shown in fig. 16, the outer stent 120 of the mitral valve device covered with the sewing film 300 is fixedly attached to the atrial wall, and the mitral valve device is fixed to the apex of the heart by the anchor 500.

The foregoing shows and describes the general principles, essential features, and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are described in the specification and illustrated only to illustrate the principle of the present invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the present invention, which fall within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.