CN219332104U

CN219332104U - Anti-reflux stent and prosthetic valve device convenient to position

Info

Publication number: CN219332104U
Application number: CN202221650517.1U
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 an anti-reflux bracket and a prosthetic valve device convenient to position, and relates to the technical field of medical appliances. The anti-reflux bracket comprises connecting pieces, positioning pieces, fastening pieces, fixing pieces and marking pieces, wherein the connecting pieces are arranged at intervals along the circumferential direction at the proximal end of the anti-reflux bracket convenient to position; a positioning piece and a fastening piece are arranged between the adjacent connecting pieces, the positioning piece and the fastening piece are respectively bent towards the proximal end of the anti-reflux bracket convenient to position, in the radial direction of the anti-reflux bracket convenient to position in the stretching state, the proximal end of the positioning piece is positioned at the outer side of the corresponding fastening piece, and a clamping space for clamping the native valve leaflet is formed between the positioning piece and the fastening piece; the marker is attached to the proximal end of the positioning member by a securing member, the marker being configured to be radiopaque. The utility model can rapidly and accurately judge whether the proximal end of the positioning piece reaches the sinus bottom, and improves the positioning efficiency and the positioning accuracy of the anti-reflux bracket convenient to position.

Description

Anti-reflux stent and prosthetic valve device convenient to position

Technical Field

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

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 stitched with the artificial valve leaflet is pressed and held, then conveyed in place by a conveyor, and then the anti-reflux bracket is released to expand so as to drive the artificial heart valve leaflet to open, and meanwhile, the primary valve leaflet is fixed. In the operation, the anti-regurgitation stent is positioned, and the inaccurate positioning can lead to the situations that the position of the artificial valve leaflet deviates from the position of the original native valve leaflet and the distance from the proximal end of the anti-regurgitation stent to the his bundle is smaller.

Therefore, there is a need to develop an anti-reflux stent that is easy to position and has a higher safety.

Disclosure of Invention

The utility model aims at providing an anti-reflux bracket and prosthetic valve device convenient to location, solved the inaccurate position that leads to prosthetic valve leaf of anti-reflux bracket and original native valve leaf's position have deviation and the near-heart end of anti-reflux bracket to the problem that the distance of his bundle is less.

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

The application provides an anti-reflux bracket convenient to location, include:

the connecting pieces are arranged at intervals along the circumferential direction at the proximal end of the anti-reflux bracket convenient to position;

the positioning piece and the fastening piece are arranged between the adjacent connecting pieces, the positioning piece and the fastening piece are respectively bent towards the proximal end of the anti-reflux bracket convenient to position, in the radial direction of the anti-reflux bracket convenient to position in a stretching state, the proximal end of the positioning piece is positioned at the outer side of the corresponding fastening piece, and a clamping space for clamping the native valve leaflet is formed between the positioning piece and the fastening piece;

a fixation member and a marker member connected to the proximal end of the positioning member by the fixation member, the marker member being arranged to be radiopaque.

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 anti-reflux bracket axis convenient to position, 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 anti-reflux bracket axis convenient to position.

Optionally, the marking element further includes a second side portion partially abutting the second side surface of the fixing element and partially abutting the inner surface of the fixing element.

Optionally, the marker is a C-shaped structure surrounded by the first side portion, the middle marker and the second side portion, and the marker is surrounded between a proximal end and a distal end of the fixing member.

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 first from one end of the middle marking part to the other end of the middle marking part, extends through the fixing piece, and then bends along the inner surface of the fixing piece.

Optionally, the marking piece further includes a second fixing plate, where the second fixing plate is attached to the outer surface of the fixing piece from one end of the middle marking portion to the other end, and then penetrates through the fixing piece, and then bends along the inner surface of the fixing piece, or is attached to the outer surface of the fixing piece, extends through the positioning piece, and then bends along the surface of the positioning piece.

Optionally, the first fixed plate is connected to the distal end of the middle marking part, and the second fixed plate is connected to 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.

Optionally, a pull wire passing hole is formed in the fixing piece, and the pull wire passing hole is used for passing a pull wire, so that the opening angle of the positioning piece relative to the axis of the anti-reflux bracket convenient to position is controlled;

the first fixing plate penetrates through the stay wire penetrating hole;

the inner wall of the stay wire passing hole comprises a connecting surface and a limiting surface, the connecting surface is used for being attached to the first fixed plate, and the limiting surface is used for clamping the first fixed plate relatively and preventing the first fixed plate from moving in the circumferential direction;

the limiting surface and the connecting surface are enclosed to form the inner wall of the stay wire passing hole;

the limiting surface is arched.

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 positioning piece comprises a first positioning arm, a second positioning arm and a positioning piece proximal end, and the first positioning arm and the second positioning arm are connected through the positioning piece proximal end; the proximal end of the fixing piece is connected with the proximal end of the positioning piece.

Optionally, the fastener includes a first fastening arm, a second fastening arm, and a fastener proximal end connecting the first fastening arm and the second fastening arm, where the first fastening arm and the second fastening arm are respectively connected to two adjacent connecting pieces;

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 is smaller than the width of the connecting block.

Optionally, the anti-reflux bracket convenient for positioning further comprises a clamping end arranged at the proximal end of the fastener, and the anti-reflux bracket convenient for positioning is anchored in an installation environment through 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 anti-reflux bracket convenient to position is in a stretching 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, the anti-reflux bracket convenient for positioning further comprises a reinforcing net arranged between adjacent fastening pieces, and the proximal end of the reinforcing net is connected with the distal end of the clamping end;

the reinforcing net comprises a first self-expansion arc, two ends of the first self-expansion arc are respectively connected with two adjacent fasteners, and the middle part of the first self-expansion arc is connected with the clamping end;

The reinforcing mesh further includes a second self-expanding arc and a third self-expanding arc, the second self-expanding arc and its corresponding third self-expanding arc being distributed along the axial direction or along the circumferential direction.

Optionally, the number of the connecting pieces is three;

the connecting pieces are uniformly distributed along the circumferential direction of the anti-reflux bracket convenient to position;

each positioning piece is provided with a fixing piece respectively;

in the axial direction of the anti-reflux bracket convenient to position, the distance from the proximal end of the positioning piece to the proximal end of the clamping end is between 4mm and 8 mm;

when the anti-reflux bracket convenient to position is in a stretching state: the locating piece extends from the distal end to the proximal end of the locating piece gradually towards a direction away from the axis of the anti-reflux bracket convenient to locate, the opening angle of the locating piece relative to the axis is 2-14 degrees, the clamping end extends from the distal end to the proximal end of the locating piece gradually towards a direction away from the axis, and the flaring angle of the clamping end relative to the axis is 6-14 degrees;

the connecting piece, the locating piece, the fixing piece, the fastening piece and the clamping end are integrally formed.

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

An anti-reflux bracket for facilitating positioning as described above;

a cover film secured to the fastener;

the artificial valve leaf is fixed on the covering film and the connecting piece and is used for controlling the opening and closing of the mounting channel;

and the anti-leakage skirt edge is arranged at the clamping end and used for preventing the anti-reflux bracket side leakage convenient to position.

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

(1) The locating piece and the fastening piece are utilized to generate a clamping space, and the locating piece in the working state is positioned between the native valve leaflet and the blood vessel wall, so that the anti-reflux bracket can be positioned by enabling the proximal end of the locating piece to be in contact with the sinus floor; the fixing piece is arranged on the positioning piece, the marking piece is arranged by the fixing piece, a doctor can observe the position of the marking piece in an image in operation, so that whether the proximal end of the positioning piece reaches the sinus bottom or not can be rapidly judged, and the positioning information of the anti-reflux bracket which is convenient to position is determined.

(2) The fixing piece is arranged at the proximal end of the positioning piece, and the position displayed by the marking piece is closer to the position information of the nearest surface of the positioning piece from the apex of the heart.

(3) The positioning piece and the fastening piece are utilized to form a clamping space, the fixing piece is arranged on the positioning piece, the stay wire penetrating holes are formed in the fixing piece, in the process of positioning the anti-reflux bracket convenient to position, the stretching degree of the positioning piece can be controlled only by retracting and releasing the stay wire, and the size of the clamping space is adjusted, so that a doctor can flexibly control the stretching of the positioning piece according to the specific condition of the installation environment, the position of a primary 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 is flexibly controlled, so that human tissues are prevented from being scratched, and the safety of the anti-reflux bracket convenient to position is improved.

(4) The fixing piece is arranged at the proximal end of the positioning piece, the marking piece is arranged by the fixing piece, a doctor can observe the position of the marking piece in an image in operation, so that whether the proximal end of the positioning piece reaches the sinus bottom or not can be rapidly judged, and the positioning information of the anti-reflux bracket convenient to position is determined.

(5) The stay wire penetrating holes are formed in the fixing piece, the marking piece is arranged on the fixing piece, the function of controlling the stretching degree of the positioning piece and the function of positioning the anti-reflux bracket convenient to position are integrated at the position of the fixing piece, the length of the anti-reflux bracket convenient to position is not increased while the two functions are realized, and the risk that the anti-reflux bracket convenient to position 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.

(6) The stretching of the positioning piece 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 to be opened relatively again in combination with the operation, then the anti-reflux bracket convenient to position is controlled by the conveying device to retract a certain distance along the blood vessel, and further the anti-reflux bracket convenient to position is subjected to reciprocating fine adjustment under the condition of not damaging human tissues.

(57) The two ends of the locating piece are connected with the two connecting pieces in one-to-one correspondence, the middle part of the locating piece is bent towards the direction of the apex of the heart to form the near-heart end of the locating piece, when the stay wire is folded and unfolded, the locating piece moves around the two ends of the locating piece, the stay wire passes through the hole to be arranged at the position of the near-heart end of the locating piece, the force arm of the movement of the locating piece is larger, and therefore the difficulty of controlling the movement of the locating piece is reduced.

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 schematic structural view of an anti-reflux bracket for positioning in an extended state according to embodiment 1 of the present utility model;

FIG. 2 is an expanded view of the positioning-facilitating anti-reflux bracket of embodiment 1 of the present utility model in a contracted state with the marker removed;

FIG. 3 is a front view of the positioning-facilitated anti-reflux bracket of embodiment 1 of the present utility model in an extended state with the marker removed;

fig. 4 is an enlarged view of a portion a of fig. 1;

fig. 5 is an enlarged view of a portion B of fig. 2;

FIG. 6 is a schematic structural view of a marking member according to embodiment 1 of the present utility model;

FIG. 7 is a schematic view showing a partial structure of an anti-reflux bracket for facilitating positioning according to another embodiment of the present utility model;

FIG. 8 is a schematic view showing a partial structure of an anti-reflux bracket for facilitating positioning according to still another embodiment of the present utility model;

fig. 9 is a schematic structural view of an anti-reflux bracket for positioning in an extended state according to embodiment 2 of the present utility model;

FIG. 10 is an expanded view of the positioning-facilitating anti-reflux bracket of example 2 of the present utility model in a contracted state with the marker removed;

FIG. 11 is a front view of the positioning-facilitating anti-reflux bracket of embodiment 2 of the present utility model in an extended state with the marker removed;

fig. 12 is an enlarged view of a portion C of fig. 9;

fig. 13 is an enlarged view of a portion D of fig. 11;

FIG. 14 is a schematic view showing a partial structure of embodiment 2 of the present utility model for embodying the structure at the proximal end of the positioning member;

FIG. 15 is a schematic view showing a partial structure of embodiment 2 of the present utility model for embodying the structure at the proximal end of the positioning member;

fig. 16 is a schematic structural view of a marker according to embodiment 2 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 non-bending state;

fig. 17 is a schematic structural view of a marker according to embodiment 2 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

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

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 an anti-reflux stent which is convenient to position, in which one end is close to the apex of the heart and the other end is remote from the apex of the heart, and in which the "proximal end" of a member refers to the end of the member which is close to the apex of the heart in the use state, and correspondingly the "distal end" of a member refers to the end of the member which is remote from the apex of the heart in the use state. The positioning-facilitating 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 an anti-reflux stent for ease of positioning, as opposed to an anti-reflux stent for ease of positioning; 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 anti-reflux mount for ease of positioning, i.e. the side opposite the inner wall of the vessel. The following description refers to the native valve leaflet in the course of an anti-reflux stent that facilitates positioning, defining the surface of the native valve leaflet that is in normal operation against which it is attached as a closed surface, and defining the surface of the native valve leaflet opposite the closed surface as a non-closed surface.

Example 1

The present embodiment is understood with reference to fig. 1 to 6. The present embodiment provides an anti-reflux stent for use in heart valve replacement, which is convenient to position in a contracted state and is delivered to a proper position by a delivery device, and finally works in a stretched state. The anti-reflux bracket convenient to position is of a hollow structure, the periphery of the 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 artificial valve leaflets.

The anti-reflux bracket convenient to position comprises a bracket main body and a marking piece 6, wherein the bracket main body adopts a hollow structure, and the periphery of the bracket main body is hollow. The bracket main body comprises a connecting piece 1, a positioning piece 2, a fastening piece 4, a fixing piece 7 and a clamping end 5.

The connecting pieces 1 are positioned at the distal end of the anti-reflux bracket convenient to position and are arranged at intervals along the circumference of the anti-reflux bracket convenient to position. 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, the part between the two ends of the positioning piece 2 is bent towards the proximal end of the anti-reflux bracket convenient to position, 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 anti-reflux bracket convenient to position.

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

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 anti-reflux bracket which is convenient to position 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 located at 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 native valve leaflet and the inner wall of a blood vessel, the native valve leaflet is conveniently located in the clamping space, and further the positioning of the anti-reflux bracket convenient to position is realized.

The marking piece 6 is made of radio-opaque metal, the marking piece 6 is correspondingly connected with the fixing piece 7, and the marking piece 6 and the fixing piece 7 are detachably connected. The fixing member 7 is connected to the proximal end of the positioning member 2, which is beneficial to more accurately determining the position information of the proximal end of the positioning member 2.

The clamping end 5 is arranged at the proximal end of the fastener 4 and plays an anchoring role, and the anti-reflux bracket convenient to position is anchored in the installation environment through the clamping end 5 to prevent the anti-reflux bracket convenient to position from moving towards the direction away from the apex of the heart.

After operation, the positioning piece 2 is positioned between the non-closed surface of the primary valve leaflet and the inner wall of the blood vessel, the outer surface of the positioning piece 2 is contacted with the inner wall of the blood vessel, the inner surface is 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 floor. A channel is formed between the closing surfaces of the native leaflets, and the fastener 4 is located inside the channel, i.e., the fastener 4 is located on the closing surface side of the native leaflet. The channel provides space for the artificial leaflet, which can be mounted directly or indirectly on the fastener 4, replacing the native leaflet and performing the function of the native leaflet.

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

(1) The positioning piece 2 and the fastening piece 4 are utilized to generate a clamping space, and the positioning piece 2 in the working state is positioned between the native valve leaflet and the blood vessel wall, so that the anti-reflux bracket can be positioned by contacting the proximal end of the positioning piece 2 with the sinus floor; the fixing piece 7 is arranged on the positioning piece 2, the marking piece 6 is arranged by the fixing piece 7, a doctor can observe the position of the marking piece 6 in an image in operation, so that whether the proximal end of the positioning piece 2 reaches the sinus bottom or not can be rapidly judged, and the positioning information of the anti-reflux bracket convenient to position is determined.

(2) The fixing member 7 is disposed at the proximal end of the positioning member 2, and the position displayed by the marking member 6 is closer to the relative position information of the positioning member 2 from the aortic sinus bottom.

In this embodiment, the bracket body is integrally formed, in other words, the connecting piece 1, the positioning piece 2, the fastening piece 4, the fixing piece 7 and the clamping end 5 are integrally formed, and during processing, the bracket body can be cut out on the nickel-titanium alloy tube, and the bracket body is in a contracted state after being cut out, and can be further processed to obtain a state in 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.

In this embodiment, the fixing members 7 are respectively disposed on each positioning member 2, and accordingly, each positioning member 2 corresponds to a marker member 6, positioning of each positioning member 2 can be performed in a targeted manner, for the case of regular native valve leaflet, the real-time position of any one marker member 6 can be observed in operation to determine the position information of the anti-reflux stent convenient for positioning, so that the positioning member 2 can quickly capture the native valve leaflet, and the anti-reflux stent convenient for positioning can be quickly implanted into a human body, and when the positioning member 2 is difficult to insert between the non-closed surface of the native valve leaflet and the inner wall of a blood vessel due to the pathological deformation in the face of irregularities and/or the native valve leaflet, one positioning member 2 beneficial to positioning can be selected, the real-time position of the marker member 6 corresponding to the positioning member 2 is mainly observed, other marker members 6 are secondarily observed, and finally the anti-reflux stent convenient for positioning can be quickly implanted into the human body.

The approach of the fixation member 7 from its proximal end to its distal end gradually towards the axis of the anti-reflux stent for ease of positioning 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 positioning piece 2 can be mounted conveniently and 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 piece 7 or abuts against the positioning piece 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.

As shown in fig. 6, the marking element 6 includes a first side portion 65, a middle marking portion 63 and a second side portion 66 which are sequentially connected, the middle marking portion 63 is attached to an outer surface of the fixing element 7, the first side portion 65 is partially attached to a first side surface 74 of the fixing element 7 and is partially attached to an inner surface of the fixing element 7, the second side portion 66 is partially attached to a second side surface 75 of the fixing element 7 and is partially attached to an inner surface of the fixing element 7, a surface of the fixing element 7 facing an axis of the anti-reflux bracket convenient to position is an inner surface, a surface facing away from the axis of the anti-reflux bracket convenient to position is an outer surface, and the first side surface 74 and the second side surface 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 other embodiments, however, the marker 6 may alternatively include other structures in addition thereto, such as the structure of embodiment 2 described below.

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, during the mounting, 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 first 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.

The stretching degree of the positioning member 2 is adjustable, and as shown in fig. 1 to 3, when the anti-reflux bracket convenient for positioning is in a stretched state: the positioning member 2 extends gradually from its distal end to its proximal end in a direction away from the axis of the positioning-facilitating anti-reflux bracket, and it is also understood that the positioning member 2 is disposed obliquely with respect to the axis of the positioning-facilitating anti-reflux bracket to form a holding 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 fixing member 7 is provided with a wire passing hole 73, the wire passing hole 73 is used for passing a wire to adjust the stretching degree of the positioning member 2, and the wire passing hole 73 is at least partially exposed from the marking member 6, i.e. the marking member 6 can occupy or cover the wire passing hole partially, but the wire passing hole 73 cannot be covered completely.

(1) The clamping space is formed by the positioning piece 2 and the fastening piece 4, the fixing piece 7 is arranged on the positioning piece 2, and the stay wire penetrating hole 73 is arranged on the fixing piece 7, so that the stretching degree of the positioning piece 2 can be controlled and the size of the clamping space can be adjusted only by retracting and releasing the stay wire in the positioning process of the anti-reflux bracket convenient to position, and 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 anti-reflux bracket convenient to position is improved.

(2) The stay wire passing hole 73 is formed in the fixing piece 7, the marking piece 6 is arranged on the fixing piece 7, the function of controlling the stretching degree of the positioning piece 2 and the function of positioning the anti-reflux bracket convenient to position are integrated at the position of the fixing piece 7, the length of the anti-reflux bracket convenient to position is not increased while the two functions are realized, and the risk that the anti-reflux bracket convenient to position 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.

(3) 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 anti-reflux bracket convenient to position is controlled by the conveying device to retract a certain distance along the blood vessel, and further the anti-reflux bracket convenient to position is subjected to reciprocating fine adjustment under the condition of not damaging human tissues.

(4) Two ends of the positioning piece 2 are connected with the two connecting pieces 1 in one-to-one correspondence, the middle part of the positioning piece 2 bends towards the direction of the apex to form the near-heart end of the positioning piece 2, when the stay wire is folded and unfolded, the positioning piece 2 moves around the two ends of the positioning piece, the stay wire passing hole 73 is arranged at the near-heart end of the positioning piece 2, the force arm of the movement of the positioning piece 2 is large, and therefore the difficulty of controlling the movement of the positioning piece 2 is reduced.

In this embodiment, the proximal end of each positioning member 2 is provided with a fixing member 7, each fixing member 7 is provided with a wire passing hole 73, and the wire passing holes 73 are provided on the limiting portion 71. The stay wires are utilized to control the positioning pieces 2 to synchronously open and contract, so that the opening angles of the positioning pieces 2 are the same, the positioning pieces 2 can quickly capture the native valve leaflets, the anti-reflux stent convenient to position is quickly implanted into a human body, and meanwhile, when the positioning pieces 2 are difficult to insert between the non-closing surface of the native valve leaflets and the inner wall of a blood vessel due to the pathological deformation of the irregular and/or native valve leaflets, the stay wires can be utilized to independently control the positioning pieces 2 to open a special angle so as to capture the corresponding native valve leaflets, so that the accuracy and the efficiency of positioning the anti-reflux stent convenient to position in operation can be improved.

As will be appreciated with reference to fig. 3, in the axial direction of the anti-reflux stent in the expanded state, the distance H between the proximal end of the positioning member 2 and the proximal end of the click end 5 is 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.

In this embodiment, the positioning members 2 have the same structure, so that the uniformity of the acting force between the anti-reflux bracket and the inner wall of the blood vessel, which is convenient for positioning, 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 to 3, 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 at their proximal ends by the proximal positioning member end 23. In this embodiment, the first positioning arm 21 and the second positioning arm 22 are symmetrically disposed, and the proximal end 23 of the positioning member is located at the middle position of the positioning arms. As shown in fig. 2, when the anti-reflux stent in a contracted state, which is convenient to position, is cut and expanded along 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 and the sinus bottom is reduced, and the risk of damaging the sinus bottom and the risk of cracking an annulus are reduced.

In this embodiment, the fasteners 4 have the same structure, so that the uniformity of the acting force between the anti-reflux bracket and the inner wall of the blood vessel, which is convenient to position, 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. 2, when the anti-reflux bracket which is in a contracted state and is convenient to position is cut along the axial direction and is unfolded, the first fastening arm 41 and the second fastening arm 42 are in a straight line shape, and the proximal end 43 of the fastening piece is in an arc shape; the anti-reflux bracket for easy positioning is in a stretched state, and the first fastening arm 41 and the second fastening arm 42 are in a curved structure.

With continued reference to fig. 1-3. In this embodiment, the number of connectors 1 is three, and accordingly, the number of positioning members 2 and fasteners 4 is three, so as to better adapt to the three native valve configurations 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 circumference of the anti-reflux bracket convenient for positioning, 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 to 3, 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 to 3, the connector 1 further includes a connection block 14 and a web 15, the connection block 14 being connected to the positioning member connection portion 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 conveying the anti-reflux bracket which is convenient to position through the catheter, the connecting block 14 is connected with the conveying device; in use, the connection block 14 is attached to the inner wall of a blood vessel.

With continued reference to fig. 1-3, in this embodiment, the positioning-facilitating anti-reflux bracket 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 positioning-friendly anti-reflux stent, the click end 5 having an angle of flaring between 6 ° and 14 ° relative to the axis of the positioning-friendly anti-reflux stent.

As shown in fig. 1 to 3, the clamping end 5 includes a plurality of clamping end structural units 51, 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 anti-reflux bracket convenient for positioning has a more uniform and stable positioning effect in the whole circumferential direction. In other embodiments, the detent end structure units 51 may be alternatively arranged at intervals, distributed along the circumference of the anti-reflux bracket for easy positioning.

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 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 to 3, 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 that 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 anti-reflux bracket convenient to position is in a stretching 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. 2, when the conveniently positioned anti-reflux stent in a contracted state is cut along an 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 to 3, the anti-reflux bracket convenient to position further comprises a reinforcing net 8 arranged between the adjacent fastening pieces 4, wherein 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 anti-reflux bracket convenient to position is improved, and the deformation degree of the anti-reflux bracket convenient to position caused by the action of 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 provided between any two adjacent fasteners 4, i.e. the anti-reflux bracket for positioning has three reinforcing meshes 8.

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 a distal end of the anti-reflux bracket with an opening facing the convenient positioning. 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 openings of the third self-expanding arc 83 being oriented opposite to each other in the expanded state. The second self-expanding arc 82 and the third self-expanding arc 83 may have different positional relationships, and a partial positional relationship is described below:

as shown in fig. 1 to 3, the second self-expanding arc 82 and the corresponding third self-expanding arc 83 are distributed along the circumferential direction of the anti-reflux bracket convenient to position, and are connected at the middle position; 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 its corresponding third self-expanding arc 83 are distributed along the circumference of the anti-reflux bracket for ease of positioning, with the two being proximate but not connected at an intermediate location; 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. 8, the second self-expanding arc 82 and its corresponding third self-expanding arc 83 are distributed along the axial direction of the conveniently positioned anti-reflux stent, and are not connected at an 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, and two ends of the third self-expansion arc 83 are respectively connected with the first self-expansion arc 81;

In other embodiments, the second self-expanding arc 82 and its corresponding third self-expanding arc 83 are distributed along the axial direction of the conveniently positioned anti-reflux stent, with the two being connected at an intermediate location; two ends of the second self-expansion arc 82 are connected with two adjacent fasteners 4 in a one-to-one correspondence manner, and two ends of the third self-expansion arc 83 are respectively connected with the first self-expansion arc 81.

Example 2

The present embodiment provides an anti-reflux bracket that is convenient for positioning, and 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. 9 to 17.

As shown in fig. 16 and 17, 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 anti-reflux bracket convenient for positioning is the inner surface, the surface facing away from the axis of the anti-reflux bracket convenient for positioning 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. 16, 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 inserted 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. 15 and 17.

Accordingly, the fixing member 7 is provided with a hole through which the first fixing plate 62 passes. As shown in fig. 9 to 15, the first fixing plate 62 in this embodiment penetrates the fixing member 7 with a wire passing hole 73. As shown in fig. 13, 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. 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. 9, 12 and 14 to 17, 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. 9, 12, 14 and 15, 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. 16, 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 the state shown in fig. 15 and 17. In other embodiments, the second fixing plate 64 may be attached to the outer surface of the fixing member 7, extend through the fixing member 7, and then be bent along the inner surface of the fixing member 7, i.e., the bar-shaped hole 24 is formed in the fixing member 7, from one end of the connecting middle marking portion 63 to the other end.

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. 15 and 17, 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. 15 and 17, 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 3

Embodiments of the present utility model also provide a prosthetic valve device including the anti-regurgitation stent for positioning and the pull wire provided in any of the above embodiments, the anti-regurgitation stent for positioning 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, as an alternative, the positioning-facilitating anti-reflux bracket controls the extent of deployment of the plurality of positioning members 2 by one pull wire.

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 fastener 4, and the covering film is arranged around the inner side of the anti-reflux bracket convenient to position and used for preventing blood from leaking laterally through the hollowed-out position of the anti-reflux bracket 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 installed 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, and a stitching gasket is not required to be added. The leak-proof skirt is arranged at the near center end of the clamping end 5 and is used for preventing the side leakage of the anti-reflux bracket which is convenient to position.

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. An anti-reflux bracket for facilitating positioning, comprising:

2. The positioning-facilitating anti-reflux bracket of claim 1, wherein the marker includes a first side portion and a middle marker portion, the middle marker portion corresponding to an outer surface of the fixture, the outer surface facing away from the positioning-facilitating anti-reflux bracket axis, the first side portion partially conforming to the first side of the fixture and partially conforming to an inner surface of the fixture facing the positioning-facilitating anti-reflux bracket axis.

3. The easy to locate anti-reflux bracket of claim 2, wherein the marker further comprises a second side portion that partially engages the second side of the mount and partially engages the inner surface of the mount.

4. The easy-to-position anti-reflux bracket of claim 3, wherein the marker is a C-shaped structure defined by the first side portion, the middle marker and the second side portion, the marker being defined between a proximal end and a distal end of the anchor.

5. The conveniently located anti-reflux bracket of claim 2 wherein the marker further comprises a first retainer plate extending from one end of the central marker portion to the other end thereof, abutting the outer surface of the fixture, extending through the fixture, and then bending along the inner surface of the fixture.

6. The anti-reflux bracket for easy positioning according to claim 5, wherein the marking member further comprises a second fixing plate, the second fixing plate extends from one end connected with the middle marking portion to the other end, and is firstly attached to the outer surface of the fixing member, then penetrates through the fixing member, and is then bent along the inner surface of the fixing member, or is firstly attached to the outer surface of the fixing member, then penetrates through the positioning member, and is then bent along the surface of the positioning member.

7. The conveniently positioned anti-reflux bracket of claim 6 wherein said first retainer plate is connected to a distal end of said central marker portion and said second retainer plate is connected to a proximal end of said central marker portion;

8. The conveniently located anti-reflux bracket of claim 5,

the fixing piece is provided with a stay wire penetrating hole, and the stay wire penetrating hole is used for the stay wire to penetrate through so as to control the opening angle of the positioning piece relative to the axis of the anti-reflux bracket convenient to position;

the first fixing plate penetrates through the stay wire penetrating hole;

the limiting surface is arched.

9. An anti-reflux bracket for facilitating positioning according to any one of claims 1 to 8, wherein the fixing member comprises a fixing plate and a limiting portion, the two ends of the fixing plate are respectively connected with the positioning member and the limiting portion, at the connection between the fixing plate and the limiting portion, the surface of the limiting portion protrudes at least partially from the surface of the fixing plate, and the marking member is located at least partially on the fixing plate.

10. The anti-reflux bracket for facilitating positioning as recited in claim 1, wherein said positioning member comprises a first positioning arm, a second positioning arm and a positioning member proximal end, said first positioning arm and said second positioning arm being connected by said positioning member proximal end; the proximal end of the fixing piece is connected with the proximal end of the positioning piece.

11. The conveniently positioned anti-reflux bracket of claim 1,

the fastener comprises a first fastening arm, a second fastening arm and a fastener proximal end for connecting 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;

12. The positioning-facilitating anti-reflux bracket of claim 1, further comprising a detent end provided at a proximal end of the fastener, the positioning-facilitating anti-reflux bracket being anchored in an installation environment by the detent end;

13. The conveniently located anti-reflux bracket of claim 12,

the anti-reflux bracket convenient to position further comprises a reinforcing net arranged between the adjacent fastening pieces, and the proximal end of the reinforcing net is connected with the distal end of the clamping end;

the reinforcing mesh further comprises a second self-expanding arc and a third self-expanding arc, the second self-expanding arc and the corresponding third self-expanding arc being distributed along an axial direction or along a circumferential direction.

14. The easy to locate anti-reflux bracket of claim 13, wherein:

the number of the connecting pieces is three;

each positioning piece is provided with a fixing piece respectively;

15. A prosthetic valve device, comprising:

an anti-reflux bracket for facilitating positioning as claimed in any one of claims 1 to 14;

a cover film secured to the fastener;

the artificial valve blades are fixed on the covering film and the connecting piece and are used for controlling the opening and closing of the mounting channel;

and the anti-leakage skirt edge is arranged at the clamping end and used for preventing side leakage of the anti-reflux bracket convenient to position.