CN219332103U

CN219332103U - Self-expanding anti-regurgitation stent and prosthetic valve device

Info

Publication number: CN219332103U
Application number: CN202221650510.XU
Authority: CN
Inventors: 吴明明; 王春光; 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2022-06-28
Filing date: 2022-06-28
Publication date: 2023-07-14
Anticipated expiration: 2032-06-28

Abstract

The utility model discloses a self-expanding anti-reflux bracket and a prosthetic valve device, and relates to the technical field of medical appliances. The utility model comprises a hollow supporting main body and positioning pieces, wherein positioning areas are formed on the supporting main body, and the positioning areas are arranged at intervals along the circumferential direction; the positioning piece is arranged in the positioning area, the positioning piece bends towards the proximal end of the self-expansion anti-reflux bracket, and a clamping space for clamping the native valve leaflet is formed between the positioning piece and the supporting main body; the support main body is provided with a plurality of first stay wire control holes, each first stay wire control hole is arranged along the circumferential interval of the self-expansion anti-reflux bracket, the first stay wire control is positioned at the middle part of the support main body in the axial direction of the self-expansion anti-reflux bracket, and the first stay wire control holes are used for allowing stay wires to pass through so as to control the diastole degree of the support main body. The utility model can control the support main body to be opened smoothly, thereby reducing the risk of damaging the blood vessel caused by sudden collapse of the support and improving the reliability and safety.

Description

Self-expanding anti-regurgitation stent and prosthetic valve device

Technical Field

The utility model relates to the technical field of medical appliances, in particular to a self-expanding anti-reflux bracket and a prosthetic valve device.

Background

Because of the advantages of small trauma and quick recovery, the transcatheter operation is becoming increasingly popular. In the case of aortic valve replacement surgery, which is performed by replacing a native valve of the heart with a prosthetic valve due to a lesion, the early surgical operation method requires cutting the sternum and suturing the prosthetic valve to the aortic valve annulus, and is currently gradually changed to replacement of the aortic valve via a catheter. Anti-reflux stents are important instruments for transcatheter aortic valve replacement, often synthesized by nitinol tube processing.

During operation, the anti-reflux bracket with the artificial valve leaflet stitched is pressed and held firstly, and then the two ends of the anti-reflux bracket are released after the anti-reflux bracket is conveyed in place by the conveyor, so that the artificial heart valve leaflet is opened, and meanwhile, the positioning piece and the primary valve leaflet are clamped. There is a risk of the anti-reflux stent collapsing open and damaging the vessel during surgery.

Therefore, there is a need to develop an anti-reflux stent with increased intraoperative safety.

Disclosure of Invention

The present application is directed to a self-expanding anti-regurgitation stent and prosthetic valve device that solves the problem of damaging the vessel by suddenly collapsing the anti-regurgitation stent.

In order to achieve the above object, the present utility model provides the following technical solutions.

The application provides a self-expanding anti-reflux stent comprising:

a hollow supporting body, wherein an opening is formed on the supporting body and is positioned in a positioning area at the distal end of the self-expansion anti-reflux bracket, and the positioning areas are arranged at intervals along the circumferential direction of the self-expansion anti-reflux bracket;

the positioning piece is arranged in the positioning area, two ends of the positioning piece are respectively connected with the distal end of the supporting main body, the positioning piece is bent towards the proximal end of the self-expansion anti-reflux bracket, in the radial direction of the self-expansion anti-reflux bracket in a stretching state, the proximal end of the positioning piece is positioned at the outer side of the supporting main body, and a clamping space for clamping the native valve leaflet is formed between the positioning piece and the supporting main body;

the support body is provided with a plurality of first stay wire control holes, each first stay wire control hole is arranged along the circumferential direction of the self-expansion anti-reflux support at intervals, the first stay wire control holes are positioned in the middle of the support body in the axial direction of the self-expansion anti-reflux support, and the first stay wire control holes are used for allowing stay wires to pass through so as to control the diastole degree of the support body.

Optionally, the first wire-drawing control holes are arranged between the adjacent positioning areas.

Optionally, the support body includes:

the connecting pieces are arranged at intervals along the circumferential direction at the distal end of the self-expansion anti-reflux bracket;

the fastener is arranged between the adjacent connecting pieces, is bent towards the proximal end of the self-expansion anti-reflux bracket, and forms the clamping space between the positioning piece and the fastener in a stretching state;

the reinforcing net is arranged between the adjacent fastening pieces, and the reinforcing net is provided with the first stay wire control holes.

Optionally, the reinforcing mesh includes at least one self-expanding arc, and the first stay wire control hole is disposed on the single self-expanding arc or disposed at a junction of a plurality of self-expanding arcs.

Optionally, the reinforcing mesh comprises a first self-expansion arc, and two ends of the first self-expansion arc are respectively connected with two adjacent fasteners; the reinforcing mesh further comprises a second self-expansion arc and a third self-expansion arc, wherein the second self-expansion arc and the corresponding third self-expansion arc are distributed along the axial direction or the circumferential direction of the self-expansion anti-reflux bracket; wherein the first self-expanding arc and/or the second self-expanding arc and/or the third self-expanding arc are/is provided with the first stay wire control hole.

Optionally, the reinforcing mesh is formed by a second self-expansion arc and a third self-expansion arc, the second self-expansion arc is connected with the third self-expansion arc and forms a cross shape, and the connection position of the second self-expansion arc and the third self-expansion arc is provided with the first wire drawing control hole.

Optionally, the supporting main body further includes a clamping end, the proximal end of the self-expanding anti-reflux bracket is anchored in the installation environment through the clamping end, and the proximal end of the reinforcing mesh is connected with the distal end of the clamping end;

the clamping end comprises a plurality of clamping end structural units which are sequentially connected and enclosed to form a hollow structure; the clamping end structure unit comprises a first clamping unit and a second clamping unit, wherein the first clamping unit is opposite to the proximal end of the fastener and connected with the fastener, and the second clamping unit is positioned between the adjacent first clamping units;

the clamping end structure unit comprises a first connecting rod, a second connecting rod, a third connecting rod and a fourth connecting rod which are sequentially connected and enclosed, wherein the joint of the first connecting rod and the fourth connecting rod forms the distal end of the clamping end structure unit, and the joint of the second connecting rod and the third connecting rod forms the proximal end of the clamping end structure unit;

When the self-expanding anti-reflux bracket is in a stretched state: the distal end of the first connecting rod and the distal end of the fourth connecting rod are respectively bent towards the direction close to each other, the proximal end of the second connecting rod and the proximal end of the third connecting rod are respectively bent towards the direction close to each other, the proximal end of the first connecting rod and the proximal end of the fourth connecting rod are respectively bent towards the direction far away from each other, and the distal end of the second connecting rod and the distal end of the third connecting rod are respectively bent towards the direction far away from each other.

Optionally, a second stay wire control hole is formed at the distal end of the connecting piece;

the connecting piece comprises a positioning piece connecting part, a fastener connecting part and a sewing part, wherein the sewing part is provided with a sewing through hole, and the sewing part is positioned between the positioning piece connecting part and the fastener connecting part;

the connecting piece further comprises a connecting block and a web, wherein the connecting block is connected with the connecting part of the positioning piece through the web; the width of the web plate is smaller than that of the connecting block, and the second stay wire control hole is formed in the connecting block;

the fastener comprises a first fastening arm, a second fastening arm and a fastener proximal end connected with the first fastening arm and the second fastening arm, wherein the first fastening arm and the second fastening arm are respectively connected with two adjacent connecting pieces.

Optionally, a pull wire passing hole is formed in the positioning piece, and the pull wire passing hole is used for passing a pull wire so as to control the diastole degree of the positioning piece;

the locating piece comprises a first locating arm, a second locating arm and a locating piece near-core end, wherein the first locating arm is connected with the second locating arm through the locating piece near-core end, and the first locating arm and/or the second locating arm and/or the locating piece near-core end is provided with a stay wire penetrating hole.

Optionally, the self-expanding anti-reflux bracket further comprises an auxiliary piece, at least one positioning piece is provided with the auxiliary piece, and two ends of the auxiliary piece are respectively connected with the first positioning arm and the second positioning arm; a V-shaped auxiliary part with at least two openings facing the proximal end of the self-expansion anti-reflux bracket is formed between the two end parts of the auxiliary part; the outer surface of the V-shaped auxiliary part is used for being attached to the inner wall of a blood vessel;

the V-shaped auxiliary part comprises a first auxiliary arm, a second auxiliary arm and an auxiliary part telecentric end, and the first auxiliary arm and the second auxiliary arm are connected through the auxiliary part telecentric end;

when the self-expanding anti-reflux bracket is in a stretching state, the distal end of the first auxiliary arm bends towards the direction of the corresponding second auxiliary arm; the distal end of the second auxiliary arm is bent towards the direction of the corresponding first auxiliary arm, and the proximal end of the first auxiliary arm is bent towards the direction away from the corresponding second auxiliary arm; the proximal end of the second auxiliary arm is bent in a direction away from the corresponding first auxiliary arm;

In the axial direction of the self-expanding anti-reflux bracket, the proximal end of the V-shaped auxiliary part at the outermost side of the auxiliary part is positioned at the middle part of the first positioning arm;

in the axial direction, the telecentric end of the V-shaped auxiliary part in the contracted state is flush with or lower than the telecentric end of the positioning piece, and the telecentric end of the V-shaped auxiliary part in the unfolded state is higher than the telecentric end of the positioning piece.

Optionally, the self-expanding anti-reflux stent further comprises a fixing member and a marking member arranged at the proximal end of the positioning member, wherein the marking member is arranged on the fixing member and is arranged to be radio-opaque; the distal end of the fixing piece is provided with the stay wire passing hole.

Optionally, the mounting includes fixed plate and spacing portion, the both ends of fixed plate are connected respectively the setting element with spacing portion the fixed plate with the junction of spacing portion, the surface of spacing portion at least part protrusion in the surface of fixed plate, the marking member is at least partly located on the fixed plate.

Optionally, the marking element includes a first side portion and a middle marking portion, the middle marking portion corresponds to an outer surface of the fixing element facing away from the self-expansion anti-reflux bracket axis, and the first side portion is partially attached to the first side surface of the fixing element and is partially attached to an inner surface of the fixing element facing toward the self-expansion anti-reflux bracket axis;

The marker also includes a second side portion partially conforming to the second side of the fixture and partially conforming to the inner surface of the fixture.

Optionally, the marking piece further includes a first fixing plate, and the first fixing plate is attached to the outer surface of the fixing piece from one end connected with the middle marking part to the other end, extends through the fixing piece, and is then bent along the inner surface of the fixing piece;

the first fixed plate penetrates through a stay wire penetrating hole at the distal end of the fixing piece;

the stay wire at the distal end of the fixing piece penetrates through the inner wall of the hole and comprises a connecting surface and a limiting surface, the connecting surface is used for being attached to the first fixing plate, and the limiting surface is used for relatively clamping the first fixing plate and preventing the first fixing plate from moving in the circumferential direction;

the limiting surface and the connecting surface enclose a stay wire penetrating through the inner wall of the hole at the distal end of the fixing piece;

the limiting surface is arched;

the marking piece further comprises a second fixed plate, wherein the second fixed plate extends from one end connected with the middle marking part to the other end, is firstly attached to the outer surface of the fixing piece and then penetrates through the fixing piece, is then bent along the inner surface of the fixing piece, or is firstly attached to the outer surface of the fixing piece and extends, penetrates through the positioning piece and is then bent along the surface of the positioning piece;

The first fixed plate is connected with the distal end of the middle marking part, and the second fixed plate is connected with the proximal end of the middle marking part;

the first fixing plate and the second fixing plate are bent along the surface of the fixing piece or the surface of the positioning piece in the same or opposite directions.

The present utility model also provides a prosthetic valve device comprising:

a self-expanding anti-reflux stent according to any one of the preceding claims;

the stay wire is at least partially penetrated through the first stay wire control hole so as to control the diastole degree of the support main body;

a cover film secured to the fastener;

an artificial leaflet fixed to the covering film and the connecting piece;

and the leakage-proof skirt edge is arranged at the clamping end and used for preventing the self-expansion type anti-reflux bracket from side leakage.

Compared with the prior art, the beneficial effects of this application include:

according to the utility model, the first stay wire control hole is formed in the circumferential direction of the support main body, when the stay wire is used, the stay wire passes through the first stay wire control hole, and the relaxation degree of the support main body is controlled by winding and unwinding the stay wire, so that the support main body is opened stably, and the risk of damaging blood vessels due to sudden collapse of the support main body is reduced; according to the utility model, the first stay wire control hole is arranged in the middle of the support main body, so that the overall diastole degree of the self-expansion type anti-reflux bracket is better controlled, and the structure of fixing the stay wire is not needed to be additionally arranged at the proximal end of the self-expansion type anti-reflux bracket, so that the length of the self-expansion type anti-reflux bracket is not increased.

Drawings

The technical features and advantages of the present utility model may be more fully understood by reference to the following detailed description taken in conjunction with the accompanying drawings.

FIG. 1 is a front view of a self-expanding anti-reflux stent according to example 1 of the present utility model in an expanded state, with markers hidden;

fig. 2 is a schematic structural view of the self-expanding anti-reflux stent according to embodiment 1 of the present utility model in a stretched state;

fig. 3 is an enlarged view of a portion a of fig. 2;

FIG. 4 is an expanded view of the self-expanding anti-reflux stent of example 1 of the present utility model in a contracted state, with the markers removed;

fig. 5 is an enlarged view of a portion B of fig. 4;

FIG. 6 is a schematic view of a marker of embodiment 1 of the present utility model;

FIG. 7 is a schematic view showing a part of a stable anti-reflux bracket according to another embodiment of the present utility model;

fig. 8 is a schematic structural view of a self-expanding anti-reflux stent according to embodiment 2 of the present utility model in a stretched state;

fig. 9 is an enlarged view of a portion D of fig. 8;

FIG. 10 is an expanded view of the self-expanding anti-reflux stent of example 2 of the present utility model in a contracted state, with the markers hidden;

fig. 11 is an enlarged view of the portion E of fig. 10;

FIG. 12 is a schematic structural view of a self-expanding anti-reflux stent according to embodiment 3 of the present utility model;

Fig. 13 is an enlarged view of the portion F of fig. 12;

FIG. 14 is an expanded view of the self-expanding anti-reflux stent of example 3 of the present utility model in a contracted state with the marker removed;

fig. 15 is an enlarged view of a portion G of fig. 14;

FIG. 16 is a schematic view showing a partial structure of a self-expanding anti-reflux stent according to embodiment 4 of the present utility model;

fig. 17 is a schematic structural view of a self-expanding anti-reflux stent according to embodiment 5 of the present utility model in a stretched state;

FIG. 18 is an expanded view of the self-expanding anti-reflux stent of example 5 of the present utility model in a contracted state with the marker removed;

fig. 19 is an enlarged view of section I of fig. 18;

FIG. 20 is a schematic view showing a partial structure of embodiment 6 of the present utility model, for showing the connection relationship between the marking member and the fixing member from one view;

FIG. 21 is a schematic view showing a partial structure of embodiment 6 of the present utility model for embodying the connection relationship between the tag and the fixing member from another view;

FIG. 22 is a schematic view showing a partial structure of embodiment 6 of the present utility model for showing the connection relationship between the marking member and the fixing member from a further view;

FIG. 23 is a schematic view showing a partial structure of embodiment 6 of the present utility model, which is used to embody the structure of the fixing member;

FIG. 24 is a schematic structural view of a marker according to embodiment 6 of the present utility model, wherein the first fixing plate, the second fixing plate, the first side portion and the second side portion are in an unfolded state;

Fig. 25 is a schematic structural diagram of a marker according to embodiment 6 of the present utility model, wherein the first fixing plate, the second fixing plate, the first side portion and the second side portion are in a bent state.

Reference numerals:

connecting piece 1

Positioning piece connecting part 11

Fastener attachment portion 12

Stitch portion 13

Stitching through hole 131

Connecting block 14

Web 15

Positioning piece 2

First positioning arm 21

Second positioning arm 22

Proximal end 23 of the positioning member

Strip-shaped hole 24

Auxiliary part 3

V-shaped auxiliary portion 31

First auxiliary arm 311

Second auxiliary arm 312

Auxiliary distal end 313

Fastener 4

First fastening arm 41

Second fastening arm 42

Fastener proximal end 43

Clamping end 5

Clamping end structure unit 51

First connecting rod 511

Second connecting rod 512

Third connecting rod 513

Fourth connecting rod 514

First positioning unit 52

Second clamping unit 53

Marking element 6

First fixing plate 62

Middle marking part 63

Second fixed plate 64

First side portion 65

Second side 66

Fixing piece 7

Limit part 71

Fixing plate 72

Wire passing hole 73

Connection face 731

Limiting surface 732

First side surface 74

Second side 75

Reinforcing mesh 8

First self-expanding arc 81

Second self-expanding arc 82

Third self-expanding arc 83

First stay wire control hole 91

Second stay wire control hole 92

Detailed Description

Unless defined otherwise, technical or scientific terms used in the specification and claims should be given the ordinary meaning as understood by one of ordinary skill in the art to which the utility model pertains.

In the description of the present utility model, it should be understood that the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, are merely for convenience in describing the present utility model and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present utility model.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first", "a second", etc. may explicitly or implicitly include one or more such feature. In the description of the present utility model, unless otherwise indicated, the meaning of "a plurality" is two or more.

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

The following examples relate to self-expanding anti-reflux stents having one end which is proximal to the apex of the heart and the other end which is distal to the apex of the heart, and in the course of the description the "proximal end" of a member refers to the end of the member which is proximal to the apex of the heart in the in-use condition, and correspondingly the "distal end" of a member refers to the end of the member which is distal to the apex of the heart in the in-use condition. The self-expanding anti-reflux stent according to any of the following embodiments is capable of being expanded and compressed, in an expanded state, defining a "stretched state", in a use state; in the non-use state, it is artificially compressed in the radial direction to a state, defined as a "contracted state", for ease of storage and protection. The following description refers to "circumferential", "axial", "radial" and "axial" references in the course of a self-expanding anti-reflux stent; it should be noted that, the "axial direction" herein generally refers to a direction in which the "axis" is located, and does not refer to a position limitation, for example, when the "axis" extends up and down, the "axial direction" is understood as "vertical direction" rather than merely a position in which the "axis" is located. Reference to the outer surface of a member in the following description refers to the side of the member facing away from the axis of the self-expanding anti-reflux stent, i.e. the side opposite the inner wall of the vessel. The following description refers to the native valve leaflet in the process of self-expanding anti-regurgitation stent, the surface that defines the native valve leaflet that is in contact with each other during normal operation is the closing surface, and the surface of the native valve leaflet that is opposite the closing surface is the non-closing surface.

Example 1

The present embodiment is understood with reference to fig. 1 to 6. The present embodiments provide a self-expanding anti-reflux stent for use in heart valve replacement procedures, where the self-expanding anti-reflux stent in a contracted state is delivered to a suitable location by a delivery device and ultimately works in a deployed state. The self-expansion anti-reflux bracket is of a hollow structure, the periphery of the self-expansion anti-reflux bracket is hollow, and the hollow part is used for arranging artificial valve leaflets so as to replace the original valve leaflets and realize the functions of the self-expansion anti-reflux bracket.

The self-expanding anti-reflux stent comprises a stent body comprising a hollow supporting body and a positioning member 2. The support main body is of a hollow structure, the inside of the support main body provides an installation space for the artificial valve leaflet, and the outside of the support main body is supported on the inner wall of the blood vessel. The periphery of the supporting main body is hollowed. The support body is provided with a positioning area with one end open, the open end of the positioning area is positioned at the distal end of the self-expansion anti-reflux bracket, and the support body is also provided with a plurality of structures protruding towards the distal end of the self-expansion anti-reflux bracket, and the positioning area is formed between the adjacent protruding structures. The positioning areas are arranged at intervals along the circumferential direction of the self-expanding anti-reflux bracket.

A plurality of first wire-drawing control holes 91 are arranged between the proximal end and the distal end of the supporting body, each first wire-drawing control hole 91 is arranged along the circumferential direction of the self-expansion anti-reflux bracket at intervals, the positions of the first wire-drawing control holes 91 are approximately on the same cross section in the axial direction of the self-expansion anti-reflux bracket, the first wire-drawing control holes 91 are positioned at the middle position of the supporting body in the axial direction of the self-expansion anti-reflux bracket, and the first wire-drawing control holes 91 are used for wires to pass through so as to control the diastole degree of the supporting body. In specific application, the first stay wire control holes 91 may be arranged in one-to-one correspondence with the stay wires, and the degree of diastole of the support main body is controlled by using a plurality of stay wires together, or the degree of diastole of the support main body may be controlled by adopting a mode that one stay wire passes through a plurality of stay wire control holes.

The locating piece 2 is located in the location area, and the distal end of support main part is connected respectively at the both ends of locating piece 2, and the both ends of locating piece 2 are connected with the both sides of the opening of location area one-to-one. The positioning member 2 is bent toward the proximal end of the self-expanding anti-reflux stent. In the expanded state, as shown in fig. 2, in the radial direction of the self-expanding anti-regurgitation stent, the proximal end of the positioning member 2 is located outside the supporting body, and a clamping space for clamping the native valve leaflet is formed between the positioning member 2 and the supporting body.

As can be seen from the above, the first stay wire control hole 91 is provided in the circumferential direction of the support body in the present embodiment, when in use, the stay wire passes through the first stay wire control hole 91, and the support body is opened smoothly by controlling the diastole degree of the support body by retracting the stay wire, so that the risk of damaging the blood vessel due to sudden collapse of the support body is reduced; in this embodiment, the first stay wire control hole 91 is disposed in the middle of the supporting body, so that on one hand, the overall diastole of the self-expanding anti-reflux bracket is better controlled, and on the other hand, the structure of fixing the stay wire at the proximal end of the self-expanding anti-reflux bracket is not needed, so that the length of the self-expanding anti-reflux bracket is not increased.

The first wire control holes 91 are provided between adjacent positioning areas. In this embodiment, the first stay wire control hole 91 is disposed between adjacent positioning areas, so that the position of the first stay wire control hole 91 and the position of the positioning element 2 are staggered in the circumferential direction, and the positioning element 2 and the native valve leaflet are not affected in the process of winding and unwinding the stay wire.

The support main body comprises a connecting piece 1, a fastening piece 4, a reinforcing net 8 and a clamping end 5, wherein the connecting piece 1 is positioned at the distal end of the self-expansion anti-reflux bracket and is arranged at intervals along the circumferential direction of the self-expansion anti-reflux bracket. The adjacent connecting pieces 1 are connected through the positioning pieces 2 and the fastening pieces 4, namely, the positioning pieces 2 and the fastening pieces 4 are arranged between any group of adjacent connecting pieces 1.

The two ends of the positioning piece 2 are connected with the two adjacent connecting pieces 1 in a one-to-one correspondence manner, and the part between the two ends of the positioning piece 2 is bent towards the proximal end of the self-expansion anti-reflux bracket, namely the positioning piece 2 is bent towards the direction away from the connecting pieces 1, so that the positioning piece 2 encloses a shape with an opening towards the distal end of the self-expansion anti-reflux bracket.

Also, both ends of the fastener 4 are connected to the adjacent two connecting members 1 in one-to-one correspondence, and a portion between both ends of the fastener 4 is bent toward the proximal end of the self-expanding anti-reflux bracket, i.e., the fastener 4 is bent in a direction away from the connecting members 1, so that the fastener 4 encloses a shape with an opening toward the distal end of the self-expanding anti-reflux bracket.

The openings formed by the positioning piece 2 and the fastening piece 4 are the same, wherein, in the axial direction, the fastening piece 4 is closer to the proximal end of the self-expanding anti-reflux bracket relative to the corresponding positioning piece 2; in the stretching state, the proximal end of the positioning piece 2 is arranged in a protruding manner relative to the fastening piece 4 in the radial direction, namely, the proximal end of the positioning piece 2 is positioned on the outer side of the corresponding fastening piece 4, so that a clamping space for clamping the native valve leaflet is formed between the positioning piece 2 and the fastening piece 4, the positioning piece 2 is conveniently inserted between the non-closing surface of the native valve leaflet and the inner wall of a blood vessel, the native valve leaflet is positioned in the clamping space, and then the self-expansion type anti-reflux bracket is positioned.

The clamping end 5 is arranged at the proximal end of the fastener 4 and plays a role in anchoring, and the self-expansion anti-reflux bracket is anchored in an installation environment through the clamping end 5 and is prevented from moving towards a direction away from the apex of the heart. The proximal end of the self-expanding anti-reflux stent can be anchored with a clamping end 5.

The reinforcing mesh 8 is provided between adjacent fasteners, the reinforcing mesh being provided with first stay wire control holes 91. The distal end of the reinforcing net 8 is connected with a fastener, and the proximal end of the reinforcing net 8 is connected with the distal end of the clamping end 5; the reinforcing net 8 is used for connecting the adjacent fastening pieces 4 and the clamping ends 5 between the two fastening pieces 4, so that the radial and circumferential supporting force of the self-expansion anti-reflux bracket is improved, and the deformation degree of the self-expansion anti-reflux bracket caused by the external force is reduced; the reinforcing mesh 8 also effectively prevents the native leaflets from invading the mounting channel and interfering with the operation of the artificial leaflets. In this embodiment, a reinforcing mesh 8 is disposed between any two adjacent fasteners 4, i.e., the self-expanding anti-reflux stent has three reinforcing meshes 8.

The reinforcing mesh 8 comprises at least one self-expanding arc, on which a first stay wire control hole 91 is provided, or at the junction of a plurality of said self-expanding arcs. This embodiment is described with three self-expanding arcs as an example.

The reinforcing mesh 8 comprises a first self-expansion arc 81, two ends of the first self-expansion arc 81 are respectively connected with two adjacent fasteners 4, the middle part of the first self-expansion arc 81 is connected with the clamping end 5, and in a stretching state, the first self-expansion arc 81 forms an opening towards the distal end of the self-expansion anti-reflux bracket. The stability between the fastener 4 and the detent end 5 is enhanced by simultaneously connecting the two fasteners 4 and the detent end 5 with the first self-expanding arc 81. In this embodiment, the end of the first self-expanding arc 81 is connected to the middle position of the first fastening arm 41 or the middle position of the second fastening arm 42 to obtain better radial and circumferential supporting force and stability.

The reinforcing mesh 8 further comprises a second self-expanding arc 82 and a third self-expanding arc 83, the openings of the second self-expanding arc 82 and the third self-expanding arc 83 being oriented opposite to each other in the expanded state, the first self-expanding arc and/or the second self-expanding arc and/or the third self-expanding arc being provided with said first stay wire control holes 91. The second self-expansion arc 82 and the third self-expansion arc 83 may have different positional relationships, in this embodiment, as shown in fig. 1 to 3, the second self-expansion arc 82 and the corresponding third self-expansion arc 83 are distributed along the circumferential direction of the self-expansion anti-reflux bracket, and are connected at an intermediate position, and the first wire-drawing control hole 91 is disposed at the connecting position of the two; two ends of the second self-expansion arc 82 are respectively connected with the fastener 4 and the first self-expansion arc 81, and two ends of the third self-expansion arc 83 are respectively connected with the other fastener 4 and the first self-expansion arc 81;

As shown in fig. 7, in other embodiments, the second self-expanding arc 82 and the corresponding third self-expanding arc 83 are distributed along the circumference of the self-expanding anti-reflux bracket, and the second self-expanding arc 82 and the corresponding third self-expanding arc 83 are close to each other but not connected at the middle position, and the first wire control hole 91 is arranged on the second self-expanding arc 82; the two ends of the second self-expanding arc 82 are respectively connected with the fastener 4 and the first self-expanding arc 81, and the two ends of the third self-expanding arc 83 are respectively connected with the other fastener 4 and the first self-expanding arc 81. Indeed, it is also possible to provide the first wire control hole 91 on the third self-expanding arc 83 and/or to provide the first wire control hole 91 on both the second self-expanding arc 82 and the third self-expanding arc 83.

As will be appreciated with reference to fig. 1, in the axial direction of the self-expanding anti-reflux stent in the expanded state, the distance H from the proximal end of the click end 5 to the proximal end of the positioning member 2 can be any value between 4mm and 8mm, at which time the risk of the click end 5 touching the his bundle can be reduced. This embodiment uses 6mm, and other embodiments may use 4mm or 8mm.

As shown in fig. 1, 3 and 4, in this embodiment, when the self-expanding anti-reflux stent is in a stretched state: the click end 5 extends gradually from its distal end to its proximal end in a direction away from the axis of the self-expanding anti-reflux stent, the click end 5 having an angle of flaring relative to the axis of the self-expanding anti-reflux stent of between 6 deg. -14 deg..

As shown in fig. 1, 3 and 4, the clamping end 5 includes a plurality of clamping end structural units 51, and in this embodiment, the clamping end structural units 51 are sequentially connected and enclosed to form a hollow structure, so that the proximal end of the self-expanding anti-reflux bracket has a more uniform and stable positioning effect in the whole circumferential direction. In other embodiments, the end-of-click structural units 51 may be alternatively arranged at intervals, distributed along the circumference of the self-expanding anti-reflux stent.

The click end structure unit 51 includes a first click unit 52 facing and connected to the proximal end of the fastener 4, and a second click unit 53 located between adjacent first click units 52. An odd number of second clamping units 53 are arranged between the adjacent first clamping units 52, for example, 5 or 7 second clamping units 53 are arranged, at this time, in the switching process of the stretching state and the shrinking state, the deformation of the first clamping units 52 and the second clamping units 53 is smaller, and the radial and circumferential supporting force of the whole clamping end 5 is in a preferred range. Note that, the first detent unit 52 and the second detent unit 53 may have the same structure, and different names are defined according to the positions of the two units.

As shown in fig. 1, 2 and 4, the clamping end structure unit 51 includes a plurality of connecting rods, specifically includes a first connecting rod 511, a second connecting rod 512, a third connecting rod 513 and a fourth connecting rod 514 which are sequentially connected and enclosed, and in the switching process of the contracted state and the stretched state, the deformation of the connecting positions of the adjacent connecting rods is relatively large, and accordingly, the stress of the positions is relatively large.

The junction of the first connecting rod 511 and the fourth connecting rod 514 forms the distal end of the click-end structure unit 51, and the junction of the second connecting rod 512 and the third connecting rod 513 forms the proximal end of the click-end structure unit 51. When the self-expanding anti-reflux stent is in a stretched state: the distal ends of the first connecting rod 511 and the fourth connecting rod 514 are respectively bent in directions approaching each other, and the proximal ends of the second connecting rod 512 and the third connecting rod 513 are respectively bent in directions approaching each other; the proximal ends of the first connecting rod 511 and the fourth connecting rod 514 are respectively bent in a direction away from each other, and the distal ends of the second connecting rod 512 and the third connecting rod 513 are respectively bent in a direction away from each other; as shown in fig. 4, when the self-expanding anti-reflux stent in a contracted state is cut along the axis and expanded, the first connecting rod 511, the second connecting rod 512, the third connecting rod 513 and the fourth connecting rod 514 are respectively in a straight line shape.

As shown in fig. 1, 2 and 4, in this embodiment, the number of the connectors 1 is three, and accordingly, the number of the positioning members 2 and the fasteners 4 is three, so as to better adapt to three native valve structures of the aorta. In other embodiments, the number of connectors 1 may be set to other integer numbers, such as 2, 4, 5, etc., as an alternative.

In this embodiment, the connecting pieces 1 are uniformly distributed along the circumferential direction of the self-expanding anti-reflux stent, the acting force between each connecting piece 1 and the inner wall of the blood vessel is relatively uniform, and the risk of damage caused by relatively concentrated local stress of the inner wall of the blood vessel due to uneven distribution of the connecting pieces 1 is reduced. Indeed, in other embodiments, it is within the scope of the present utility model that the spacing between adjacent connectors 1 may vary.

As shown in fig. 1, 2 and 4, the connector 1 includes a positioning member connecting portion 11, a fastener connecting portion 12 and a sewing portion 13, the sewing portion 13 being provided with a sewing through hole 131 for sewing the distal end of the prosthetic valve; in this embodiment, the suture through hole 131 is an elongated hole, so that the convenience of suture is improved; the stitching 13 is located between the securing element connection 11 and the fastener connection 12.

As shown in fig. 1, 2 and 4, the connector 1 further comprises a connecting block 14 and a web 15, wherein the connecting block 14 is connected with the positioning piece connecting part 11 through the web 15; the width of the web 15 is smaller than the width of the connection block 14. In the process of delivering the self-expansion type anti-reflux bracket through the catheter, the connecting block 14 is connected with a delivery device; in use, the connection block 14 is attached to the inner wall of a blood vessel.

As shown in fig. 1, 2 and 4, in this embodiment, the connection block is provided with a second pull wire control hole 92 for passing a pull wire, so as to control the diastole of the distal end of the self-expanding anti-reflux bracket after being separated from the delivery device. The first stay wire control hole 91 and the second stay wire control hole 92 are used simultaneously, so that the control of the diastole degree of the self-connecting piece expansion type anti-reflux bracket can be further enhanced, and the safety of the self-connecting piece expansion type anti-reflux bracket is improved.

In this embodiment, the fasteners 4 have the same structure, so that the uniformity of the acting force between the self-expanding anti-reflux bracket and the inner wall of the blood vessel is further improved. Indeed, in other embodiments, it is within the scope of the present utility model to use different configurations for each fastener 4.

The fastener 4 comprises a first fastening arm 41, a second fastening arm 42 and a fastener proximal end 43 connecting the first fastening arm 41 and the second fastening arm 42, the distal ends of the first fastening arm 41 and the second fastening arm 42 being connected to two adjacent connectors 1, respectively. As shown in fig. 4, when the self-expanding anti-reflux stent in a contracted state is cut and expanded in the axial direction, the first fastening arm 41 and the second fastening arm 42 are linear, and the proximal end 43 of the fastener is arc-shaped; when the self-expanding anti-reflux stent is in a stretched state, the first fastening arm 41 and the second fastening arm 42 are in a curved structure.

As shown in fig. 1, 2 and 4, the self-expanding anti-reflux stent is in a deployed state: the positioning member 2 extends gradually from its distal end to its proximal end in a direction away from the axis of the self-expanding anti-reflux stent, and it is also understood that the positioning member 2 is disposed obliquely with respect to the axial direction of the self-expanding anti-reflux stent to form a clamping space. In this embodiment, the opening angle of the positioning element 2 relative to the axis is 2 ° -14 °, which not only improves the fixing effect of the native valve leaflet, but also does not influence the operation of the artificial valve leaflet by installing the native valve She Yaru in the channel.

In this embodiment, the positioning members 2 have the same structure, so that the uniformity of the acting force between the self-expanding anti-reflux stent and the inner wall of the blood vessel is further improved. Indeed, in other embodiments, each positioning member 2 may have a different structure, which is also within the scope of the present utility model.

As shown in fig. 1, 2 and 4, the positioning member 2 includes a first positioning arm 21, a second positioning arm 22 and a proximal positioning member end 23, the proximal positioning member end 23 and the proximal positioning member 2 described elsewhere herein are the same concept, and the proximal positioning arm 21 and the proximal positioning arm 22 are connected by the proximal positioning member end 23.

As shown in fig. 4, when the self-expanding anti-reflux stent in a contracted state is cut and expanded in the axial direction, the first positioning arm 21 and the second positioning arm 22 are linear, the proximal end 23 of the positioning element is arc-shaped, the contact area between the proximal end 23 of the arc-shaped positioning element and the sinus bottom is increased, the contact stress between the proximal end 23 of the positioning element and the sinus bottom is reduced, and the risk of damaging the sinus bottom and the risk of cracking an annulus are reduced.

The bracket main body also comprises an auxiliary piece 3, at least one positioning piece 2 is provided with the auxiliary piece 3, at least two V-shaped auxiliary parts 31 with openings facing the proximal end of the self-expansion anti-reflux bracket are formed between two end parts of the auxiliary piece 3, and the openings of the V-shaped auxiliary parts 31 are opposite to the openings formed by the positioning piece 2. The outer surface of the V-shaped auxiliary portion 31 is used to fit the inner wall of the blood vessel, increasing the contact area with the inner wall of the blood vessel, and increasing the supporting force in the radial and circumferential directions.

Under the application working condition, the positioning piece 2 and the auxiliary piece 3 are positioned between the non-closed surface of the primary valve leaflet and the inner wall of the blood vessel, the outer surfaces of the positioning piece 2 and the auxiliary piece 3 are contacted with the inner wall of the blood vessel, the inner surfaces are contacted with the non-closed surface of the primary valve leaflet, and the proximal end of the positioning piece 2 is contacted with the sinus bottom. A channel is formed between the closing surfaces of the primary valve blades to provide space for the artificial valve blades, and the artificial valve blades can be directly or indirectly arranged on the supporting main body to replace the primary valve blades and realize the functions of the primary valve blades.

From the above description, embodiments of the present utility model have at least the following advantages:

(1) An auxiliary piece 3 is arranged on the positioning piece 2, and the auxiliary piece 3 is utilized to enhance the stability of the self-expansion type anti-reflux bracket in function.

(2) The auxiliary piece 3 is arranged on the positioning piece 2, and the contact area between the self-expansion anti-reflux bracket and the inner wall of the blood vessel is increased by utilizing the contact between the outer surface of the auxiliary piece 3 and the blood vessel, so that the static friction force between the self-expansion anti-reflux bracket and the inner wall of the blood vessel is improved, the risk of displacement of the self-expansion anti-reflux bracket relative to the inner wall of the blood vessel is reduced, and the stability of the position of the self-expansion anti-reflux bracket is improved; on the other hand, the contact area between the self-expansion anti-reflux bracket and the native valve leaflet is increased, and the fixation effect on the native valve leaflet is improved, so that the functional stability of the self-expansion anti-reflux bracket is enhanced.

(3) By arranging the auxiliary piece 3 at the position of the positioning area and enabling the outer surface of the auxiliary piece 3 to be in contact with the blood vessel, the radial and circumferential supporting force of the self-expansion type anti-reflux bracket is enhanced, and the stability of the position of the self-expansion type anti-reflux bracket is further improved; meanwhile, the contact area with the native valve leaflet is increased, and the fixation effect on the native valve leaflet is improved, so that the stability of the self-expansion type anti-reflux bracket in function is further improved.

(4) The point contact between the distal end of the self-expansion anti-reflux bracket and the inner wall of the blood vessel is realized through the convex structure, and meanwhile, the linear contact is realized through the V-shaped auxiliary part 31, so that the continuity of the contact area between the circumferential direction of the distal end of the self-expansion anti-reflux bracket and the inner wall of the blood vessel is improved, and the stability of the position of the self-expansion anti-reflux bracket is enhanced; meanwhile, the continuity of the contact area between the circumferential direction of the distal end of the self-expansion anti-reflux bracket and the native valve leaflet is improved, and the stability of the position of the self-expansion anti-reflux bracket is further improved.

(5) The opening formed by the positioning member 2 faces the distal end of the self-expanding anti-reflux bracket, and the opening formed by the V-shaped auxiliary portion 31 and the opening formed by the positioning member 2 face opposite, so that the distal end of the V-shaped auxiliary portion 31 is closer to the cross section where the connecting portion 1 is located or can be located at the cross section where the connecting portion 1 is located, and the distance from the proximal end of the positioning member 2 to the distal end 1 of the installed anti-reflux bracket in the axial direction is larger, so that it is difficult to provide a larger circumferential supporting force for the distal end of the installed anti-reflux bracket, and conversely, the distal end of the V-shaped auxiliary portion 31 is closer to the cross section where the distal end of the installed anti-reflux bracket is located, therefore, the auxiliary member 3 can more effectively share the acting force at the distal end of the installed anti-reflux bracket, and cooperate with the distal end of the installed anti-reflux bracket, so as to jointly improve the circumferential supporting force of the anti-reflux bracket convenient to adjust.

(6) Compared with the structure in which the auxiliary member 3 is composed of one V-shaped auxiliary portion 31, the auxiliary member 3 of the present embodiment includes at least two V-shaped auxiliary portions 31, so that the angle of each V-shaped auxiliary portion 31 is smaller, the deformation of the V-shaped auxiliary portion 31 in the process from the contracted state to the stretched state is smaller, the auxiliary member is not easy to break, and the reliability of the self-expanding anti-reflux bracket is improved.

In this embodiment, the positioning areas have three, be provided with a setting element 2 in every positioning area, be provided with an auxiliary member 3 on every setting element 2, correspond respectively on three setting element 2 to have two at least V type auxiliary portion 31 promptly to the distal end of self-expanding anti-reflux support is more even in the atress in circumference, has reduced the risk that because of the uneven distal end distribution of the anti-reflux support of installation leads to the blood vessel inner wall local stress comparatively concentrated and damages.

As shown in fig. 1, 3 and 4, in the present embodiment, the auxiliary member 3 has two V-shaped auxiliary portions 31, that is, two V-shaped auxiliary portions 31 are respectively disposed on the three positioning members 2, so that the deformation of the V-shaped auxiliary portions 31 is small during the switching process of the contracted state and the stretched state, and meanwhile, the moderate elasticity of the auxiliary member 3 is ensured. One end of each V-shaped auxiliary portion 31 is connected to the positioning member 2, and the other end is connected to the other V-shaped auxiliary portion 31.

As shown in fig. 1, 3 and 4, the V-shaped auxiliary portion 31 includes a first auxiliary arm 311, a second auxiliary arm 312 and an auxiliary distal end 313, and the first auxiliary arm 311 and the second auxiliary arm 312 are connected by the auxiliary distal end 313, so that a sharp included angle is avoided between the distal ends of the first auxiliary arm 311 and the second auxiliary arm 312, thereby reducing the risk of damaging the inner wall of a blood vessel or a native leaflet during elastic deformation and during switching between a stretched state and a contracted state. In this embodiment, the auxiliary portion distal end 313 adopts an arc structure, so that the safety is further ensured.

As shown in fig. 4, when the self-expanding anti-reflux stent in a contracted state is cut and expanded in the axial direction, the first auxiliary arm 311 and the second auxiliary arm 312 are linear.

As shown in fig. 1, 3 and 4, when the self-expanding anti-reflux stent is in a stretched state, the first auxiliary arm 311 and the second auxiliary arm 312 are in a curved structure, specifically, the distal end of the first auxiliary arm 311 is bent towards the corresponding second auxiliary arm 312, and the distal end of the second auxiliary arm 312 is bent towards the corresponding first auxiliary arm 311, so that the included angle formed by the distal end of the V-shaped auxiliary portion 31 is smaller, and the distal end of the V-shaped auxiliary portion 31 can absorb acting force better and is not easy to break when switching between the stretched state and the contracted state. The proximal end of the first auxiliary arm 311 is bent in a direction away from the corresponding second auxiliary arm 312, and the proximal end of the second auxiliary arm 312 is bent in a direction away from the corresponding first auxiliary arm 311, so that not only can the stress be optimized, but also the included angle formed by the connection position of the adjacent V-shaped auxiliary parts 31 becomes smaller, and the connection position can absorb the acting force better and is not easy to break when switching between the extended state and the contracted state. The V-shaped auxiliary portion 31 is configured as described above, that is, the proximal end of the first auxiliary arm 311 and the distal end of the first auxiliary arm 311 are different in bending direction, the proximal end of the second auxiliary arm 312 and the distal end of the second auxiliary arm 312 are different in bending direction, and the total length of the auxiliary member 3 is increased without increasing the linear distance between the proximal end and the distal end of the auxiliary member 3, so that the contact area between the auxiliary member 3 and the inner wall of the blood vessel and the native valve is increased, and the stability and reliability of the self-expanding anti-reflux stent are improved.

As shown in fig. 1, 3 and 4, in the embodiment, when the self-expanding anti-reflux stent is in a stretched state, the first auxiliary arm 311 extends smoothly along a curve from its proximal end to its distal end, and the second auxiliary arm 312 extends smoothly along a curve from its proximal end to its distal end, which is not only beneficial for optimizing stress, but also reduces the risk of rubbing against the inner wall of the blood vessel and the native valve leaflet.

As shown in fig. 1, 3 and 4, the bending amplitude of the positioning element 2 at the position of the positioning element near-center end 23 is the largest, and the two ends of the auxiliary element 3 are respectively connected with the first positioning arm 21 and the second positioning arm 22, so that the auxiliary element 3 spans the corresponding position of the positioning element near-center end 23 in the process of extending from one end to the other end in the circumferential direction, namely, the auxiliary element 3 spans the region with large bending amplitude of the positioning element 2, the stress of the positioning element 2 and the auxiliary element 3 can be more uniform, and the stress distribution between the auxiliary element 3 and the positioning element 2 is optimized. Indeed, in other embodiments, it is within the scope of the utility model that both ends of the auxiliary element 3 are provided on the first positioning arm 21 or the second positioning arm 22 as an alternative.

As shown in fig. 1, 3 and 4, in the axial direction of the self-expanding anti-reflux bracket, the proximal end of the V-shaped auxiliary portion 31 is located at the middle position of the first positioning arm 21, and indeed, the proximal end of the V-shaped auxiliary portion 31 is also located at the middle position of the second positioning arm 22. In the extended state, the distance between the first positioning arm 21 and the second positioning arm 22 is large from the middle position of the first positioning arm 21 to the distal end thereof in the axial direction, and the V-shaped auxiliary portion 31 is provided to extend from the middle position of the first positioning arm 21 in a direction away from the proximal end of the self-expanding anti-reflux stent, so that not only the supporting force can be enhanced, but also the fixation effect on the native valve leaflet can be improved.

As shown in fig. 4, the auxiliary member 3 provided with the plurality of V-shaped auxiliary portions 31 has the effect that the distal end of the V-shaped auxiliary portion 31 in the contracted state is flush with the distal end of the positioning member 2 or lower than the distal end of the positioning member 2, and the interference of the auxiliary member 3 when the distal end of the self-expanding anti-reflux stent is connected to the delivery device is reduced, and since the plurality of V-shaped auxiliary portions 31 are provided, the opening angle of the first auxiliary arm 311 and the second auxiliary arm 312 is small during the self-expanding anti-reflux stent from the contracted state to the expanded state, and the variation width of the auxiliary member 3 with respect to the axial direction is small, the distal end of the V-shaped auxiliary portion 31 in the expanded state is higher than the distal end of the positioning member 2, and the region between the two distal ends of the positioning member 2 can be supported not only by the distal end of the auxiliary member 3 on the inner wall of the blood vessel but also by the proximal end of the auxiliary member 3 contacting the inner wall of the blood vessel and the native valve.

As shown in fig. 1, 3 and 4, the self-expanding anti-reflux stent further comprises a marker 6 and a fixing member 7, wherein the proximal end of the fixing member 7 is connected with the proximal end of the positioning member 2, and the marker 6 is detachably mounted on the fixing member 7, so that the position displayed by the marker 6 is closer to the relative position information of the positioning member 2 from the aortic sinus bottom. The marker 6 is made of radiopaque metal, and during operation, the position of the marker 6 is observed through images to determine whether the proximal end of the positioning member 2 reaches the sinus floor.

As shown in fig. 1, 3 and 4, in the present embodiment, the distal end of the fixing member 7 is also provided with a pull wire passing hole 73, so that the function of controlling the stretching degree of the positioning member 2 and the function of positioning the self-expanding anti-reflux bracket are integrated at the position of the fixing member 7, the length of the self-expanding anti-reflux bracket is not increased while the two functions are realized, and the risk that the self-expanding anti-reflux bracket touches the his bundle or other human tissues due to the large length is avoided; meanwhile, the device has the effects of compact structure and high space utilization rate.

In addition, in this embodiment, by providing two wire passing holes 73 near the proximal end of the positioning member 2, that is, the wire passing hole 73 on the fixing member 7 and the wire passing hole 73 on the proximal end 23 of the positioning member, safety redundancy is provided, on the one hand, when one wire passing hole 73 is not applicable any more, the other wire passing hole 73 can be used to control the degree of relaxation of the positioning member 2, and on the other hand, the two wire passing holes 73 can be used to control the degree of relaxation of the positioning member 2 at the same time, thereby improving reliability and stability. In this embodiment, the axis of the pull wire passing hole 73 on the fixing member 7 and the axis of the pull wire passing hole 73 on the proximal end 23 of the positioning member are located in the same plane, so that the first positioning arm 21 and the second positioning arm 22 are uniformly stressed.

In this embodiment, the fixing elements 7 are respectively disposed on each positioning element 2, the distal end of each fixing element 7 is provided with a stay wire passing hole 73, and accordingly, each positioning element 2 is also correspondingly provided with a marker 6, the positioning of each positioning element 2 can be targeted, for the case of regular native valve leaflets, the real-time position of any one marker 6 can be observed in operation to judge the position information of the self-expanding anti-reflux stent, so that the positioning element 2 can quickly capture the native valve leaflets, and the self-expanding anti-reflux stent can be quickly implanted into a human body, and when the non-closed surface of the native valve leaflets and the inner wall of a blood vessel are difficult to insert the positioning element 2 due to the pathological deformation of the native valve leaflets, one positioning element 2 which is beneficial to the positioning can be selected, the real-time position of the marker 6 corresponding to the positioning element 2 is mainly observed, other markers 6 are observed in an auxiliary way, and finally the self-expanding anti-reflux stent can be quickly implanted into the human body.

The approach of the fixation member 7 gradually towards the axis of the self-expanding anti-reflux stent from its proximal end to its distal end is also understood to mean that the fixation member 7 is arranged obliquely with respect to the axis so that the distal end of the fixation member 7 can abut against the non-closing surface of the native leaflet.

The fixing member 7 includes a limiting portion 71 for preventing the marking member 6 from being separated from the distal end of the fixing member 7, the fixing member 7 further includes a fixing plate 72, the marking member 6 is mounted on the fixing plate 72, one end of the fixing plate 72 is connected with the positioning member 2, the other end is connected with the limiting portion 71, at the connection of the fixing plate 72 and the limiting portion 71, at least part of the surface of the limiting portion 71 protrudes relative to the surface of the fixing plate 72, so as to limit the marking member 6, and a pull wire passing hole 73 is formed in the limiting portion 71.

In practical application, the length of the fixing plate 72 can be set to be greater than the length of the marker 6, the marker 6 can generate displacement along the fixing plate 72 in the axial direction, so that a margin is reserved for mounting the marker 6, the marker is convenient to mount on the positioning element 2 quickly, as an alternative means, the manner that the distal end of the marker 6 abuts against the limiting part 71 and the proximal end of the marker 6 abuts against the proximal end of the fixing element 7 or abuts against the positioning element 2 can be adopted, so that the displacement freedom degree of the marker 6 on the axis is restrained, and the risk that the inner wall of a blood vessel and the native valve leaflet are damaged due to the axial movement of the marker 6 is eliminated.

In this embodiment, the limiting portion 71 is a plate with a circular outline, and in other embodiments, the limiting portion 71 may be a protruding structure on the fixing plate 72 or a baffle partially embedded on the fixing plate 72.

In this embodiment, the pull wire passing hole 73 on the fixing member 7 is at least partially exposed from the marking member 6, i.e. the marking member 6 may partially occupy or cover the pull wire passing hole, but not entirely cover the pull wire passing hole 73.

As shown in fig. 6, the marker 6 includes a first side 65, a middle marker 63, and a second side 66 connected in sequence, the middle marker 63 is attached to the outer surface of the fixing element 7, the first side 65 is partially attached to the first side 74 of the fixing element 7 and partially attached to the inner surface of the fixing element 7, the second side 66 is partially attached to the second side 75 of the fixing element 7 and partially attached to the inner surface of the fixing element 7, wherein the surface of the fixing element 7 facing the axis of the self-expanding anti-reflux bracket is the inner surface, the surface facing away from the axis of the self-expanding anti-reflux bracket is the outer surface, and the first side 74 and the second side 75 are located between the inner surface and the outer surface.

In this embodiment, the marker 6 is a C-shaped structure surrounded by the first side portion 65, the middle marker 63 and the second side portion 66, the marker 6 is disposed through from the proximal end to the distal end of the marker 6, and the marker 6 is disposed between the proximal end and the distal end of the fixing member 7, that is, the marker 6 is disposed around the surface of the fixing plate 72 and is located on the fixing plate 72.

In specific application, the marking element 6 may be a bendable board, before installation, the first side portion 65, the second side portion 66 and the middle marking portion 63 may be located in the same plane, when installation, the middle marking portion 63 of the bendable board is attached to the fixing plate 72 of the fixing element 7, and then the first side portion 65 and the second side portion 66 are respectively bent along the side face of the fixing plate 72, and then are bent along the inner surface of the fixing plate 72. Alternatively, before the mounting, the first side portion 65 and the middle marking portion 63 are subjected to a bending process in advance, the second side portion 66 and the middle marking portion 63 are also subjected to a bending process in advance, and when the mounting is performed, the middle marking portion 63 of the bending plate is bonded to the fixing plate 72 of the fixing member 7, the first side portion 65 is bonded to the first side surface 74 of the fixing plate 72, the second side portion 66 is bonded to the second side surface 75 of the fixing plate 72, and then the first side portion 65 and the second side portion 66 are respectively bonded to the inner surface of the fixing plate 72.

In this embodiment, one end of the first side portion 65 and one end of the second side portion 66 are disposed opposite to each other with a gap therebetween. In other embodiments, one end of the first side portion 65 and one end of the second side portion 66 may be attached or overlapped as an alternative.

The thickness of the middle marking part 63 can be set to be smaller than the thickness of other positions of the bending plate, so that the influence of the marking part 6 on the flatness of the outer side of the positioning part 2 is effectively reduced, and the influence of the roughness of the proximal end of the positioning part 2 on the inner wall of a blood vessel is reduced.

Example 2

The present embodiment provides a self-expanding anti-reflux stent, which differs from embodiment 1 in the relationship of the second self-expanding arch and the third to expanding arches. As shown in fig. 8-11, in this embodiment, the second self-expanding arc 82 and its corresponding third self-expanding arc 83 are distributed along the axial direction of the self-expanding anti-reflux stent, and are not connected at the intermediate position; two ends of the second self-expansion arc 82 are connected with two adjacent fasteners 4 in a one-to-one correspondence manner, two ends of the third self-expansion arc 83 are respectively connected with the first self-expansion arc 81, and the first stay wire control hole 91 is arranged on the third self-expansion arc 83.

Example 3

As shown in fig. 12-15, this embodiment provides a self-expanding anti-reflux stent, which is different from embodiment 1 in that the proximal end of the positioning member 2 of this embodiment is provided with a pull wire passing hole 73, the limiting portion of the fixing member is not provided with a pull wire passing hole 73, and the connecting member is not provided with a second control hole.

The stay wire passes through the hole 73 for the stay wire to pass through, and the stretching and retracting of the stay wire can control the diastole degree of the positioning piece 2, so that the relative position relation between the positioning piece 2 and the native valve leaflet is adjusted, and the position relation between the clamping space and the native valve leaflet is adjusted, so that the positioning piece 2 can quickly capture the native valve leaflet. One or more pull wire passing holes 73 may be provided, wherein at least one pull wire passing hole 73 is provided at the proximal end of the positioning member 2.

As can be seen from the above, the self-expanding anti-reflux stent of the present embodiment has at least the following advantages:

(1) The clamping space is formed by the positioning piece 2 and the supporting main body, and the stay wire penetrating hole 73 is formed in the positioning piece 2, so that the stretching degree of the positioning piece 2 can be controlled only by retracting and releasing the stay wire in the process of positioning the self-expansion anti-reflux bracket, and the size of the clamping space is adjusted, therefore, a doctor can flexibly control the stretching of the positioning piece 2 according to the specific condition of the installation environment, the position of a native valve leaflet can be quickly and accurately captured, the times of repeatedly adjusting the anti-reflux bracket are reduced, and the positioning efficiency is improved; meanwhile, in the positioning process, the stretching degree of the positioning piece 2 is flexibly controlled, so that human tissues are prevented from being scratched, and the safety of the self-expansion type anti-reflux bracket is improved.

(2) The stretching of the positioning piece 2 can be flexibly controlled according to the specific condition of the installation environment in the operation, so that a doctor can control the positioning piece 2 to be opened relatively again in combination with the operation, then the self-expansion type anti-reflux bracket is controlled by the conveying device to retract a certain distance along a blood vessel, and further the self-expansion type anti-reflux bracket is subjected to reciprocating fine adjustment under the condition of not damaging human tissues.

(3) The two ends of the locating piece 2 are connected with the two ends of the supporting body formed at the opening of the locating area in a one-to-one correspondence mode, the middle of the locating piece 2 is bent towards the direction of the apex of the heart to form the near-heart end of the locating piece 2, when the stay wire is retracted and released, the locating piece 2 moves around the two ends of the locating piece, the stay wire passes through the hole 73 to be arranged at the position of the near-heart end of the locating piece 2, the force arm of the movement of the locating piece 2 is large, and therefore the difficulty of controlling the movement of the locating piece 2 is reduced.

In this embodiment, the pull wire passing hole 73 is provided on the proximal end 23 of the positioning member, and in other embodiments, the pull wire passing hole 73 may be provided on the first positioning arm 21 and/or the second positioning arm 22 as an alternative.

In this embodiment, the first positioning arm 21 and the corresponding second positioning arm 22 are symmetrically disposed, and the first positioning arm 21 and the corresponding second positioning arm 22 are symmetrical with respect to a first plane, the proximal end 23 of the positioning member is located at the middle position of the positioning member 2, the first plane passes through the proximal end 23 of the positioning member, a pull wire passing hole 73 is disposed on the proximal end 23 of the positioning member, and the axis of the pull wire passing hole 73 is located on the first plane, so that when the pull wire is retracted and released, the acting force of the proximal end 23 of the positioning member can be uniformly dispersed to the first positioning arm 21 and the second positioning arm 22, in other words, the stress of the first positioning arm 21 and the second positioning arm 22 is more uniform, so that the force used for stretching the positioning member 2 by the same amplitude is small. In other embodiments, it is within the scope of the present utility model to provide a plurality of pull-wire passing holes 73 on the proximal end 23 of the positioning member that are axially in a first plane, or to provide pull-wire passing holes 73 on the proximal end 23 of the positioning member that are located outside of the first plane.

Example 4

As shown in fig. 16, this embodiment provides a self-expanding anti-reflux stent, which is different from embodiment 3 in that a pull wire passing hole 73 is also provided in the limiting portion 71 of the fixing member of this embodiment. Other parts of this embodiment are the same as those of embodiment 3, and will not be described here again.

Example 5

As shown in fig. 17-19, this embodiment provides a self-expanding anti-reflux stent, which is different from embodiment 1 in that no auxiliary member is provided in this embodiment. Other parts of this embodiment are the same as those of embodiment 1, and will not be described here again.

Example 6

The present embodiment provides a self-expanding anti-reflux stent, which is different from embodiment 1 in the structures of the marker 6, the fixing member 7 and the positioning member 2, and is described in detail below with reference to fig. 20 to 25.

As shown in fig. 24 and 25, the marker 6 includes a first side portion 65, a middle marker 63, and a second side portion 66 connected in sequence, the middle marker 63 is attached to the outer surface of the fixture 7, the first side portion 65 is partially attached to the first side surface 74 of the fixture 7, and is partially attached to the inner surface of the fixture 7, that is, the first side portion 65 is bent, and partially wraps the fixture 7. The second side 66 is partially attached to the second side 75 of the fixing element 7 and partially attached to the inner surface of the fixing element 7, wherein the surface of the fixing element 7 facing the axis of the self-expanding anti-reflux bracket is the inner surface, the surface facing away from the axis of the self-expanding anti-reflux bracket is the outer surface, and the two sides between the inner surface and the outer surface are the first side 74 and the second side 75, respectively.

The marker 6 further comprises a first fixed plate 62, wherein the first fixed plate 62 is connected with a middle marker 63, and the first fixed plate 62 and the middle marker are in smooth transition at the connecting position so as to reduce the risk of scratching the inner wall of a blood vessel; the first fixing plate 62 extends from one end connected with the middle marking part 63 to the other end, is attached to the outer surface of the fixing piece 7, penetrates through the fixing piece 7, and is bent along the inner surface of the fixing piece 7 to form a U-shaped structure, so that the middle marking part 63 is positioned on the fixing piece 7. As shown in fig. 24, before the marker 6 and the bracket main body are mounted, the first fixing plate 62 is in a straight state, during the mounting process, the first fixing plate 62 is penetrated through the fixing member 7, the middle marker 63 is adjusted to be attached to the fixing member 7, and then the first fixing plate 62 is bent to form a state as shown in fig. 20 to 22 and fig. 25.

Accordingly, the fixing member 7 is provided with a hole through which the first fixing plate 62 passes. As shown in fig. 20 to 25, the first fixing plate 62 in this embodiment penetrates the fixing member 7 with a wire passing hole 73. As shown in fig. 23, the inner wall of the wire passing hole 73 includes a connection surface 731 and a limiting surface 732, the connection surface 731 is used for being attached to the first fixing plate 62, and the limiting surface 732 is relatively clamped to the first fixing plate 62, so as to prevent the first fixing plate 62 from moving in the circumferential direction, so as to improve the stability of the marker 6. The limiting surface 732 and the connecting surface 731 enclose the inner wall of the synthetic pull wire passing hole 73; the connection surface 731 is a plane, and the limiting surface 732 is an arch. It should be noted that, the function of the hole is herein used to define whether the hole is a wire passing hole, and the shapes of the wire passing holes at different positions may be different, for example, the wire passing hole on the fixing element 7 is surrounded by the connection surface 731 and the limiting surface 732, and the inner wall of the wire passing hole at the proximal end of the positioning element 2 is a cylindrical surface.

In other embodiments, a square Kong Gongdi plate 62 may be provided on the anchor 7 independently of the wire passing holes 73 as an alternative.

In other embodiments, the marker 6 may be formed by the first side portion 65, the middle marker 63, the second side portion 66 and the first fixing plate 62, but in this embodiment, the marker 6 further includes a second fixing plate 64, as shown in fig. 20 to 22, 24 and 25, where the second fixing plate 64 and the middle marker 63 are connected, and the two parts smoothly transition at the connecting position to reduce the risk of scratching the inner wall of the blood vessel.

As shown in fig. 20 to 22, 24 and 25, the second fixing plate 64 is attached to the outer surface of the fixing member 7 from one end connected to the middle marking portion 63 to the other end, extends through the bar-shaped hole 24 on the positioning member 2, and is bent along the surface of the positioning member 2 to form a U-shaped structure, so that the middle marking portion 63 is positioned on the fixing member 7. As shown in fig. 24, before the marker 6 and the bracket main body are mounted, the second fixing plate 64 is in a straight state, and during the mounting process, the second fixing plate 64 is first inserted through the fixing member 7, and after the middle marker 63 is adjusted to be attached to the fixing member 7, the second fixing plate 64 is bent to form a state as shown in fig. 25.

In this embodiment, the first fixing plate 62 is connected to the distal end of the middle marking portion 63, and the second fixing plate 64 is connected to the proximal end of the middle marking portion 63; the first fixing plate 62 and the second fixing plate 64 are bent in the same or opposite directions along the surface of the fixing member 7 or the positioning member 2.

As shown in fig. 22 and 25, in the present embodiment, one end of the first side portion 65 and one end of the second side portion 66 are disposed opposite to each other with a gap therebetween. In other embodiments, one end of the first side portion 65 and one end of the second side portion 66 may be attached or overlapped as an alternative.

As shown in fig. 22 and 25, in the present embodiment, a distance exists between the other end of the first fixing plate 62 and the other end of the second fixing plate 64 to give way to the first side portion 65 and the second side portion 66. In other embodiments, a distance may be provided between one end of the first side portion 65 and one end of the second side portion 66 to yield the first and

second securing plates

62, 64 as an alternative.

It should be noted that:

the marker 6 of the present embodiment may be understood as having the first fixing plate 62 and the second fixing plate 64 added thereto in addition to the C-shape of embodiment 1. The fixing member 7 of the present embodiment differs from that of embodiment 1 only in the structure of the wire passing hole 73. The retainer 2 of the present embodiment differs from that of embodiment 1 only in that the retainer 2 of the present embodiment has a strip-shaped hole 24.

Other parts of this embodiment are the same as those of embodiment 1, and will not be described here again.

Example 7

Embodiments of the present utility model also provide a prosthetic valve device comprising the self-expanding anti-regurgitation stent provided in any of the above embodiments and a pull wire forming a mounting channel, the pull wire being disposed through the pull wire passing hole 73.

In this embodiment, each positioning member 2 corresponds to a pull wire, and each positioning member 2 is individually controlled by the pull wire. In other embodiments, the self-expanding anti-reflux stent controls the extent of deployment of the plurality of positioning members 2 by a single pull wire as an alternative.

The artificial valve device further comprises a covering film, artificial valve blades and a leakage-proof skirt, wherein the covering film is fixed on the fastening piece 4, and the covering film is arranged around the inner side of the self-expansion anti-reflux bracket for preventing blood from leaking laterally through the hollowed-out position of the anti-reflux bracket which is convenient to adjust; the artificial valve leaflet is fixed on the tectorial membrane, and further the distal end both sides of the artificial valve leaflet are fixedly arranged on the stitching part 13 of the connecting piece 1, namely, the edge of the distal end of the artificial valve leaflet directly passes through the strip-shaped stitching through hole 131 to be stitched without adding stitching gaskets, compared with the traditional mode of fixing the artificial valve leaflet by mutually extruding gaskets and a reverse flow bracket, the method firstly reduces the additional parts of the self-expansion reverse flow bracket, and has no gaskets, is also beneficial to further compression of the self-expansion reverse flow bracket, and if the gaskets exist, not only the compression of the bracket is affected, but also the artificial valve leaflet can be damaged even under the condition that the compression size of the bracket is smaller. The leak-proof skirt edge is arranged at the near center end of the clamping end 5 and is used for preventing the self-expansion type anti-reflux bracket from leaking.

In the description herein, the connecting piece 1, the positioning piece 2, the auxiliary piece 3, the fastening piece 4, the fixing piece 7 and the clamping end 5 are integrally formed, and during processing, the connecting piece can be cut out on the nitinol tube, the stent body is in a contracted state after being cut out, and the stent body can be further processed to obtain a stretched state. Indeed, in other embodiments, it is within the scope of the present utility model to use multiple zero (part) connections for the stent body.

It will be evident to those skilled in the art that the utility model is not limited to the details of the foregoing illustrative embodiments, and that the present utility model may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, the scope of the utility model being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.

Claims

1. A self-expanding anti-reflux stent comprising:

2. The self-expanding anti-reflux stent of claim 1, wherein the first wire-pulling control holes are disposed between adjacent ones of the positioning areas.

3. The self-expanding anti-reflux stent of claim 1, wherein the support body comprises:

4. A self-expanding anti-reflux stent as recited in claim 3, wherein said reinforcement mesh includes at least one self-expanding arc, and said first stay wire control hole is provided on said single self-expanding arc or at a junction of a plurality of said self-expanding arcs.

5. A self-expanding anti-reflux stent according to claim 3, wherein the reinforcing mesh comprises a first self-expanding arc, two ends of the first self-expanding arc being connected to two adjacent fasteners, respectively; the reinforcing mesh further comprises a second self-expansion arc and a third self-expansion arc, wherein the second self-expansion arc and the corresponding third self-expansion arc are distributed along the axial direction or the circumferential direction of the self-expansion anti-reflux bracket; wherein the first self-expanding arc and/or the second self-expanding arc and/or the third self-expanding arc are/is provided with the first stay wire control hole.

6. A self-expanding anti-reflux stent as recited in claim 3, wherein the reinforcement mesh is formed of a second self-expanding arc and a third self-expanding arc, the second self-expanding arc connecting the third self-expanding arc and forming a cross shape, the position where the second self-expanding arc and the third self-expanding arc are connected being provided with the first wire-drawing control hole.

7. The self-expanding anti-reflux stent of claim 3, wherein the support body further comprises a clip end by which a proximal end of the self-expanding anti-reflux stent is anchored in an installation environment, the proximal end of the reinforcing mesh being connected to a distal end of the clip end;

8. The self-expanding anti-reflux stent of claim 3,

the distal end of the connecting piece is provided with a second stay wire control hole;

9. The self-expanding anti-reflux stent of claim 1, wherein the positioning member is provided with a pull-wire passing hole through which the pull-wire passes to control the degree of diastole of the positioning member;

10. The self-expanding anti-reflux stent of claim 9,

the self-expansion anti-reflux bracket further comprises auxiliary pieces, wherein at least one positioning piece is provided with the auxiliary pieces, and two ends of each auxiliary piece are respectively connected with the first positioning arm and the second positioning arm; a V-shaped auxiliary part with at least two openings facing the proximal end of the self-expansion anti-reflux bracket is formed between the two end parts of the auxiliary part; the outer surface of the V-shaped auxiliary part is used for being attached to the inner wall of a blood vessel;

11. The self-expanding anti-reflux stent of claim 1, further comprising a securing member disposed at a proximal end of the positioning member and a marker disposed on the securing member, the marker being configured to be radiopaque; the distal end of the fixing piece is provided with the stay wire passing hole.

12. The self-expanding anti-reflux bracket according to claim 11, wherein the fixing member comprises a fixing plate and a limiting portion, two ends of the fixing plate are respectively connected with the positioning member and the limiting portion, at the connection position of the fixing plate and the limiting portion, the surface of the limiting portion protrudes out of the surface of the fixing plate at least partially, and the marking member is located on the fixing plate at least partially.

13. The self-expanding anti-reflux stent of claim 11, wherein the marker comprises a first side portion and a middle marker portion, the middle marker portion corresponding to an outer surface of the securing member facing away from the self-expanding anti-reflux stent axis, the first side portion partially conforming to a first side surface of the securing member and partially conforming to an inner surface of the securing member facing toward the self-expanding anti-reflux stent axis;

14. The self-expanding anti-reflux bracket as recited in claim 13, wherein the marker further comprises a first retainer plate extending from one end of the central marker portion to the other end thereof, first engaging the outer surface of the fixture, then extending through the fixture, and then bending along the inner surface of the fixture;

the limiting surface is arched;

15. A prosthetic valve device, comprising:

the self-expanding anti-reflux stent of any one of claims 1-14;

a cover film secured to the fastener;

an artificial leaflet fixed to the covering film and the connecting piece;