CN219332105U

CN219332105U - High stability anti-reflux stent and prosthetic valve device

Info

Publication number: CN219332105U
Application number: CN202221650532.6U
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 high-stability anti-reflux bracket and a prosthetic valve device, and relates to the technical field of medical appliances. The anti-reflux bracket comprises connecting pieces, positioning pieces, auxiliary pieces, fastening pieces and marking pieces, wherein the connecting pieces are arranged at intervals along the circumferential direction at the distal end of the high-stability anti-reflux bracket; a positioning piece and a fastening piece are arranged between the adjacent connecting pieces, and are respectively bent towards the proximal end of the high-stability anti-reflux bracket; in the stretching state, a clamping space for clamping the primary valve leaflet is formed between the positioning piece and the fastening piece; a V-shaped auxiliary part with at least two openings facing the proximal end of the high-stability 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 the blood vessel; the marking piece is arranged at the proximal end of the positioning piece. The utility model increases the contact area between the high-stability anti-reflux stent and the inner wall of the blood vessel and the primary valve leaflet, and improves the stability of the high-stability anti-reflux stent.

Description

High stability anti-reflux stent and prosthetic valve device

Technical Field

The utility model relates to the technical field of medical equipment, in particular to a high-stability 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 stitched with the artificial heart 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.

Chinese patent publication No. CN105125322a discloses a novel prosthetic valve prosthesis having three upper fittings. However, the distal end of the novel prosthetic valve prosthesis contacts the inner wall of the aorta through three upper matching pieces, the contact area is small, the static friction force is small, and the position stability of the novel prosthetic valve prosthesis relative to the inner wall of the aorta is poor; meanwhile, the stress born by the inner wall of the aorta is large, and the damage to the aorta caused by the sliding of the novel artificial valve prosthesis relative to the inner wall of the aorta is large; in addition, the contact area between the three upper matching pieces and the primary valve leaflet is small, the fixing effect on the primary valve leaflet is limited, and the novel prosthetic valve prosthesis is poor in stability in function.

Therefore, it is necessary to develop an anti-reflux stent with high stability.

Disclosure of Invention

The present application aims to provide a high-stability anti-regurgitation stent and a prosthetic valve device, which solve the problems of poor position stability of the anti-regurgitation stent relative to the inner wall of an aorta and poor fixation effect on native valve leaflets.

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

The application provides a high stability anti-reflux bracket, include:

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

the positioning piece and the fastening piece are arranged between the adjacent connecting pieces, and are respectively bent towards the proximal end of the high-stability anti-reflux bracket; in the extended state: in the radial direction of the high-stability anti-reflux bracket, 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 primary valve leaflet is formed between the positioning piece and the fastening piece;

the auxiliary piece is arranged on at least one positioning piece, and a V-shaped auxiliary part with at least two openings facing the proximal end of the high-stability anti-reflux bracket is formed between two end parts of the auxiliary piece; the outer surface of the V-shaped auxiliary part is used for being attached to the inner wall of a blood vessel;

And the marker is arranged at the proximal end of the positioning piece and is not transparent to rays.

Optionally, the V-shaped auxiliary part includes a first auxiliary arm, a second auxiliary arm, and an auxiliary part distal end, and the first auxiliary arm and the second auxiliary arm are connected through the auxiliary part distal end.

Optionally, when the high-stability anti-reflux bracket is in a stretched state, the distal end of the first auxiliary arm is bent 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/or the number of the groups of groups,

when the high-stability anti-reflux bracket is in a stretching state, the proximal end of the first auxiliary arm bends towards a direction away from the corresponding second auxiliary arm; the proximal end of the second auxiliary arm is curved in a direction away from its corresponding first auxiliary arm.

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 two ends of the auxiliary piece are respectively connected with the first positioning arm and the second positioning arm.

Optionally, in the axial direction of the high-stability anti-reflux bracket, the proximal end of the V-shaped auxiliary part on the outermost side of the auxiliary member is located at the middle position of the first positioning arm;

in the axial direction of the high-stability anti-reflux bracket, the telecentric end of the V-shaped auxiliary part in a 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 a stretched state is higher than the telecentric end of the positioning piece.

Optionally, the high-stability anti-reflux bracket further comprises a fixing piece, wherein the proximal end of the fixing piece is connected with the positioning piece, and the marking piece is correspondingly connected with the fixing piece.

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 fixing element gradually approaches to the axis of the high-stability anti-reflux bracket from the proximal end to the distal end;

the fixing piece is provided with a stay wire penetrating hole through which the stay wire penetrates to control the opening angle of the positioning piece relative to the axis of the high-stability anti-reflux bracket;

The stay wire penetrating hole is formed in the distal end of the fixing piece.

Optionally, the marking element is C-shaped, and the marking element is disposed through from the proximal end to the distal end, and the marking element is enclosed between the proximal end and the distal end of the fixing element;

the marking piece comprises a first side part, a middle marking part and a second side part which are sequentially connected, wherein the middle marking part is attached to the outer surface of the fixing piece, the first side part is locally attached to one side surface of the fixing piece and is locally attached to the inner surface of the fixing piece, and the second side part is locally attached to one side surface of the fixing piece and is locally attached to the inner surface of the fixing 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, the first fastening arm and the second fastening arm respectively connecting two adjacent connectors.

Optionally, the connecting piece comprises a positioning piece connecting part, a fastener connecting part and a stitching part, wherein the stitching part is provided with a stitching through hole, and the stitching 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 high-stability anti-reflux bracket further comprises a clamping end arranged at the proximal end of the fastener, and the high-stability anti-reflux bracket is anchored in an installation environment through the clamping end;

when the high-stability anti-reflux bracket is in a stretching state: the clamping end extends gradually from the telecentric end to the proximal end of the clamping end in a direction away from the axis, and the expansion angle of the clamping end relative to the axis is between 6 degrees and 14 degrees;

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 high-stability anti-reflux bracket is in a stretching state: the distal ends of the first connecting rod and the fourth connecting rod are respectively bent towards the directions approaching each other, and the proximal ends of the second connecting rod and the third connecting rod are respectively bent towards the directions approaching each other;

when the high-stability anti-reflux bracket is in a stretching state: the proximal ends of the first connecting rod and the fourth connecting rod are respectively bent in a direction away from each other, and the distal ends of the second connecting rod and the third connecting rod are respectively bent in a direction away from each other.

the high-stability anti-reflux bracket further comprises a reinforcing net arranged between the adjacent fastening pieces, wherein 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 high-stability anti-reflux bracket;

each positioning piece is provided with one auxiliary piece;

the auxiliary piece is provided with two V-shaped auxiliary parts, wherein one end of each V-shaped auxiliary part is connected with the positioning piece, and the other end of each V-shaped auxiliary part is connected with the other V-shaped auxiliary part;

in the axial direction of the high-stability anti-reflux bracket, 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 high-stability anti-reflux bracket is in a stretching state: the positioning piece extends from the distal end to the proximal end of the positioning piece gradually to a direction away from the axis of the high-stability anti-reflux bracket, and the opening angle of the positioning piece relative to the axis is 2-14 degrees;

the connecting piece, the locating piece, the fastening piece and the auxiliary piece are integrally formed.

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

A high stability anti-reflux bracket as claimed in any one of the preceding claims, the reflux bracket forming a mounting channel;

a cover film secured to the fastener;

an artificial valve blade fixed on the covering film and sewed with the connecting piece, wherein the artificial valve blade 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 high-stability anti-reflux bracket from leaking on the side.

Compared with the prior art, the beneficial effect of this application lies in:

(1) The auxiliary piece is arranged on the positioning piece, the marking piece is arranged at the proximal end of the positioning piece, the stability of the high-stability anti-reflux bracket in function is enhanced by the aid piece, the positioning of the positioning piece and the auxiliary piece is realized by the aid piece, and the risk that the positioning piece and the auxiliary piece rub the inner wall of a blood vessel due to repeated adjustment in the positioning process is reduced.

(2) The auxiliary piece is arranged on the positioning piece, and the contact area between the high-stability 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 and the blood vessel, so that the static friction force between the high-stability anti-reflux bracket and the inner wall of the blood vessel is improved, the risk of displacement of the high-stability anti-reflux bracket relative to the inner wall of the blood vessel is reduced, and the stability of the position of the high-stability anti-reflux bracket is improved; on the other hand, the contact area between the high-stability 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 high-stability anti-reflux bracket is enhanced.

(3) The adjacent connecting pieces and the positioning pieces between the adjacent connecting pieces and the adjacent connecting pieces form a hollowed-out area with an upward opening, and the outer surfaces of the auxiliary pieces are contacted with blood vessels by arranging the auxiliary pieces at the position of the hollowed-out area, so that the radial and circumferential supporting force of the high-stability anti-reflux bracket is enhanced, and the stability of the position of the high-stability 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 functional stability of the high-stability anti-reflux bracket is further improved.

(4) The point contact is carried out between the distal end of the high-stability anti-reflux bracket and the inner wall of the blood vessel through the connecting piece, and meanwhile, the linear contact is also realized through the V-shaped auxiliary part, so that the continuity of the contact area between the circumferential direction of the distal end of the high-stability anti-reflux bracket and the inner wall of the blood vessel is improved, and the stability of the position of the high-stability anti-reflux bracket is improved; meanwhile, the continuity of the contact area between the circumferential direction of the distal end of the high-stability anti-reflux bracket and the native valve leaflet is improved, and the stability of the position of the high-stability anti-reflux bracket is further improved.

(5) The locating piece is crooked towards the direction of keeping away from the connecting piece, the opening that the locating piece formed is towards the distal end of high stability anti-reflux support, and the opening of V type auxiliary part and the opening that the locating piece formed are opposite to each other to the distal end of V type auxiliary part is closer to the cross section at connecting portion place, perhaps can be in the cross section department at connecting portion place, and in the axial, the distance of the near-heart end of locating piece from the connecting piece is great, be difficult to provide great circumference holding power for the connecting piece, the distal end of opposite V type auxiliary part is closer to the cross section at connecting piece place, consequently the effort at connecting piece place can be shared more effectively to the auxiliary part, with the cooperation of connecting piece, improve this high stability anti-reflux support circumference holding power jointly.

(6) Compared with a structure that the auxiliary piece is composed of a V-shaped auxiliary part, the auxiliary piece of the embodiment comprises at least two V-shaped auxiliary parts, the angle of each V-shaped auxiliary part is smaller, the deformation of the V-shaped auxiliary part in the process from a contracted state to a stretched state is small, the V-shaped auxiliary part is not easy to break, and the reliability of the high-stability anti-reflux bracket is improved.

(7) The near-heart end of the high-stability anti-reflux bracket can be anchored by using the clamping end, the far-heart end can be fixed on the inner wall of a blood vessel by being connected with the connecting piece and the auxiliary piece, and the position between the near-heart end and the far-heart end of the high-stability anti-reflux bracket can be supported on the inner wall of the blood vessel by the positioning piece, so that the high-stability anti-reflux bracket has higher stability and reliability as a whole.

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 a high stability anti-reflux stent according to an embodiment of the present utility model, wherein the high stability anti-reflux stent is in a stretched state;

FIG. 2 is an expanded view of a high stability anti-reflux stent according to an embodiment of the present utility model in a contracted state with markers removed;

FIG. 3 is a front view of a high stability anti-reflux bracket according to one embodiment of the present utility model with markers hidden;

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 view of a marker according to an embodiment of the present utility model;

fig. 7 is a schematic partial structure of a high-stability anti-reflux bracket according to an embodiment of the utility model.

Fig. 8 is a schematic partial structure of a high-stability anti-reflux bracket according to another embodiment of the utility model.

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

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

Middle marking part 61

First side portion 62

Second side 63

Fixing piece 7

Limit part 71

Fixing plate 72

Wire passing hole 73

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 a high stability anti-reflux stent 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 in use, and in which the "proximal end" of a member refers to the end of the member which is proximal to the apex of the heart in use, 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 use. The high stability anti-reflux stent according to any of the following embodiments is capable of being expanded and compressed, in an expanded state, defined as 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 describes the "circumferential", "axial", "radial" and "axial" references in the course of a high stability 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 high stability anti-reflux stent, i.e. the side opposite the inner wall of the vessel. The following description relates to native leaflets in the course of a high stability anti-reflux stent, defining the surface of the native leaflet that is in contact with the native leaflet during normal operation as a closed surface, and defining the surface of the native leaflet opposite the closed surface as a non-closed surface.

Please understand with reference to fig. 1 to 3. The embodiment of the utility model provides a high-stability anti-reflux stent which is used in heart valve replacement, and the high-stability anti-reflux stent in a contracted state is released after being conveyed to a proper position by a conveying device and finally works in a stretched state. The high-stability anti-reflux bracket is of a hollow structure, the periphery of the high-stability anti-reflux bracket is hollow, and the hollow part is used for arranging artificial valve leaflets so as to realize the function of the original valve leaflets.

The high-stability anti-reflux bracket 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, an auxiliary piece 3, a fastening piece 4 and a clamping end 5.

The connecting pieces 1 are positioned at the distal end of the high-stability anti-reflux bracket and are arranged at intervals along the circumference of the high-stability anti-reflux bracket. Adjacent connecting pieces 1 are connected through positioning pieces 2, namely, the positioning pieces 2 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 high-stability 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 high-stability anti-reflux bracket.

Also, both end portions of the fastener 4 are connected to the adjacent two connecting members 1 in one-to-one correspondence, and a portion between the two end portions of the fastener 4 is bent toward the proximal end of the high-stability 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 high-stability 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 high-stability 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 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 located in the clamping space, and then the positioning of the high-stability anti-reflux bracket is realized.

At least one positioning piece 2 is provided with an auxiliary piece 3, at least two V-shaped auxiliary parts 31 with openings facing the proximal end of the high-stability 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.

The marker 6 is made of radiopaque metal and the marker 6 is directly or indirectly attached to 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 high-stability anti-reflux bracket is anchored in an installation environment through the clamping end and is prevented from moving towards a direction away from the apex of the heart.

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 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 auxiliary piece 3 is arranged on the positioning piece 2, the marker piece 6 is arranged at the proximal end of the positioning piece 2, the stability of the high-stability anti-reflux bracket in function is enhanced by the aid piece 3, the positioning of the positioning piece 2 and the auxiliary piece 3 is realized by the aid of the marker piece 6, and the risk that the positioning piece 2 and the auxiliary piece 3 rub against the inner wall of a blood vessel due to repeated adjustment in the positioning process is reduced.

(2) The auxiliary piece 3 is arranged on the positioning piece 2, and the contact area between the high-stability 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 high-stability anti-reflux bracket and the inner wall of the blood vessel is improved, the risk of displacement of the high-stability anti-reflux bracket relative to the inner wall of the blood vessel is reduced, and the stability of the position of the high-stability anti-reflux bracket is improved; on the other hand, the contact area between the high-stability 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 high-stability anti-reflux bracket is enhanced.

(3) The adjacent connecting pieces 1 and the positioning pieces 2 between the two form a hollowed-out area with an upward opening, and the auxiliary piece 3 is arranged at the position of the hollowed-out area, so that the outer surface of the auxiliary piece 3 is in contact with a blood vessel, the radial and circumferential supporting force of the high-stability anti-reflux bracket is enhanced, and the stability of the position of the high-stability 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 functional stability of the high-stability anti-reflux bracket is further improved.

(4) The point contact between the distal end of the high-stability anti-reflux bracket and the inner wall of the blood vessel is carried out through the connecting piece 1, and meanwhile, the linear contact is also 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 high-stability anti-reflux bracket and the inner wall of the blood vessel is improved, and the stability of the position of the high-stability anti-reflux bracket is improved; meanwhile, the continuity of the contact area between the circumferential direction of the distal end of the high-stability anti-reflux bracket and the native valve leaflet is improved, and the stability of the position of the high-stability anti-reflux bracket is further improved.

(5) The positioning piece 2 is bent towards the direction away from the connecting piece 1, the opening formed by the positioning piece 2 faces towards the distal end of the high-stability anti-reflux bracket, and the opening formed by the V-shaped auxiliary part 31 and the opening formed by the positioning piece 2 face opposite to each other, so that the distal end of the V-shaped auxiliary part 31 is closer to the cross section where the connecting piece 1 is located or can be positioned at the cross section where the connecting piece 1 is located, the distance from the proximal end of the positioning piece 2 to the connecting piece 1 in the axial direction is larger, larger circumferential supporting force is difficult to provide for the connecting piece 1, and conversely, the distal end of the V-shaped auxiliary part 31 is closer to the cross section where the connecting piece 1 is located, and therefore the auxiliary piece 3 can more effectively share acting force at the connecting piece 1 and cooperate with the connecting piece 1 to jointly improve the circumferential supporting force of the high-stability anti-reflux bracket.

(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, deformation of the V-shaped auxiliary portion 31 in the process from the contracted state to the stretched state is small, breakage is not easy, and reliability of the high-stability anti-reflux bracket is improved.

(7) The proximal end of the high-stability anti-reflux stent can be anchored by using the clamping end 5, the distal end can be fixedly connected with the inner wall of a blood vessel by the connecting piece 1 and the auxiliary piece 3, and the position between the proximal end and the distal end of the high-stability anti-reflux stent can be further supported on the inner wall of the blood vessel by the positioning piece 2, so that the high-stability anti-reflux stent has higher stability and reliability as a whole.

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

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.

With continued reference to fig. 1-3. In this embodiment, the connecting pieces 1 are uniformly distributed along the circumferential direction of the high-stability anti-reflux bracket, 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.

In this embodiment, the positioning members 2 have the same structure, and the fastening members 4 have the same structure, so that the uniformity of the acting force between the high-stability anti-reflux bracket and the inner wall of the blood vessel is further improved. It is understood that in other embodiments, different configurations for each positioning member 2 and/or different configurations for each fastener 4 are within the scope of the present utility model.

In this embodiment, an auxiliary member 3 is disposed on each positioning member 2, that is, at least two V-shaped auxiliary portions 31 are respectively disposed on each three positioning members 2, so that the stress of the distal end of the high-stability anti-reflux bracket in the circumferential direction is more uniform, and the risk of damage caused by concentrated local stress on the inner wall of the blood vessel due to uneven distribution of the connecting members 1 is reduced.

With continued reference to fig. 1 to 3, 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 ensured to be smaller during the switching process of the contracted state and the stretched state, and meanwhile, the elasticity of the auxiliary member 3 is ensured to be moderate. 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 to 3, 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 through the auxiliary distal end 313, so that a sharp included angle is prevented from being formed 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 deployed 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. 2, when the high-stability 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 and fig. 3, when the high-stability anti-reflux bracket 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 direction of the corresponding second auxiliary arm 312, and the distal end of the second auxiliary arm 312 is bent towards the direction of 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 better absorb the acting force and is not easy to break when the stretched state and the contracted state are switched. 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 part 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, 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 high-stability anti-reflux stent are improved without increasing the linear distance between the proximal end and the distal end of the auxiliary member 3.

As shown in fig. 1 and 3, in the present embodiment, when the high-stability 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 the inner wall of the blood vessel and the native valve leaflet.

As shown in fig. 1 to 3, the positioning member 2 includes a first positioning arm 21, a second positioning arm 22, and a positioning member proximal end 23, wherein the proximal ends of the first positioning arm 21 and the second positioning arm 22 are connected by the positioning member proximal end 23, in this embodiment, the first positioning arm 21 and the second positioning arm 22 are symmetrically disposed, and the positioning member proximal end 23 is located at a middle position of the positioning arm. As shown in fig. 2, when the high-stability anti-reflux stent in a contracted state 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 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.

As shown in fig. 1 to 3, the bending amplitude of the positioning element 2 at the position of the positioning element proximal end 23 is maximum, 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 proximal 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 to 3, in the axial direction of the high-stability 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 high-stability 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. 2, the auxiliary member 3 provided with the plurality of V-shaped auxiliary portions 31 has the distal end of the V-shaped auxiliary portion 31 in the contracted state 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 connecting member 1 is connected to the delivery device is reduced, and since the plurality of V-shaped auxiliary portions 31 are provided, the angle at which the first auxiliary arm 311 and the second auxiliary arm 312 open during the stable anti-reflux stent is from the contracted state to the expanded state is small, and the amplitude of change 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 therefore, 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 leaflet.

With continued reference to fig. 1-3, in this embodiment, the high stability 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 high stability anti-reflux stent, which is also understood to mean that the positioning member 2 is disposed obliquely with respect to the axial direction of the high stability anti-reflux stent such that the distal end of the positioning member 2 abuts against the non-closing surface of the native leaflet. 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.

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

In this embodiment, the anti-reflux bracket with high stability further comprises a fixing member 7, the marking member 6 is connected to the positioning member 2 through the fixing member 7, and in other embodiments, it is also within the scope of the present utility model to directly connect the marking member 6 to the proximal end of the positioning member 2 as an alternative.

Referring to fig. 4 to 6, the proximal end of the high-stability fixing member 7 is connected to the positioning member 2, the marking member 6 is detachably mounted on the fixing member 7, and in the operation process, whether the proximal end of the positioning member 2 reaches the sinus floor is determined by observing the position of the marking member 6 through images.

In this embodiment, the fixing element 7 gradually approaches the axis of the high-stability anti-reflux stent from the proximal end to the distal end thereof, and it is also understood that the fixing element 7 is disposed obliquely with respect to the axis, so that the distal end of the fixing element 7 can abut against the non-closed surface of the native leaflet.

In this embodiment, the fixing member 7 includes a limiting portion 71 for preventing the marker 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 marker 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, and at the connection position of the fixing plate 72 and the limiting portion 71, at least part of the surface of the limiting portion 71 protrudes with respect to the surface of the fixing plate 72, so as to limit the marker member 6. 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.

The distal end of the fixing member 7 is provided with a stay wire passing hole 73, and the stay wire passing hole 73 is used for the stay wire to pass through so as to control the opening angle of the positioning member 2 relative to the axis of the high-stability anti-reflux bracket, and in the application process, the opening angle of the positioning member 2 is controlled by using the stay wire in combination with the specific environment in the operation. The pull-wire passing hole 73 is at least partially exposed to the marker 6, i.e. the marker 6 may partially occupy or cover the pull-wire passing hole, but not entirely cover the pull-wire passing hole 73.

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

(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 winding and unwinding the stay wire in the process of positioning the high-stability anti-reflux bracket, a doctor can flexibly control the stretching of the positioning piece 2 according to the specific condition of the installation environment, the positions of the primary valve leaflets 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 high-stability anti-reflux bracket is improved.

(2) The fixing piece 7 is arranged at the proximal end of the positioning piece 2, the marking piece 6 is arranged by using the fixing piece 7, and a doctor can observe the position of the marking piece 6 in an image in an 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 high-stability anti-reflux bracket can be determined.

(3) 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 high-stability anti-reflux bracket are integrated at the position of the fixing piece 7, the length of the high-stability anti-reflux bracket is not increased while the two functions are realized, and the risk that the high-stability 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.

(4) 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 contraction of the positioning piece 2 in combination with the operation, then the high-stability anti-reflux bracket is controlled by the conveying device to retract a certain distance along a blood vessel, and the reciprocating fine-tuning high-stability anti-reflux bracket under the condition of not damaging human tissues is realized.

(5) 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 high-stability anti-reflux stent is quickly implanted into a human body, and meanwhile, when the positioning pieces 2 are difficult to insert between the non-closed surface of the native valve leaflets and the inner wall of a blood vessel due to the pathological deformation of the 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 high-stability anti-reflux stent in operation can be improved.

As shown in fig. 6, in this embodiment, the marking member 6 is C-shaped, and the marking member 6 is disposed through from the proximal end to the distal end thereof, and the marking member 6 is disposed around the surface of the fixing plate 72 between the proximal end and the distal end of the fixing member 7. The marking member 6 includes a first side portion 62, a middle marking portion 61 and a second side portion 63 connected in sequence, the middle marking portion 61 is attached to an outer surface of the fixing member 7, the first side portion 62 is partially attached to one side surface of the fixing member 7 and is partially attached to an inner surface of the fixing member 7, and the second side portion 63 is partially attached to one side surface of the fixing member 7 and is partially attached to an inner surface of the fixing member 7.

In this embodiment, one end of the first side portion 62 and one end of the second side portion 63 are disposed opposite to each other with a gap therebetween. In other embodiments, one end of the first side portion 62 and one end of the second side portion 63 may be attached or overlapped as an alternative.

In a specific application, the marking element 6 may be a bending plate capable of bending, and when the marking element is installed, the middle marking portion 61 of the bending plate is attached to the fixing plate 72 of the fixing element 7, the first side portion 62 is attached to one side surface of the fixing element 7, the second side portion 63 is attached to the other side surface of the fixing element 7, and then the first side portion 62 and the second side portion 63 are respectively attached to the inner surface of the fixing plate 72 for bending.

In specific application, the thickness of the middle marking part 61 can be set smaller than the thicknesses of the first side part 62 and the second side part 63, 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 uneven near-center end of the positioning part 2 on the inner wall of a blood vessel is reduced.

As shown in fig. 1 to 3, the fastener 4 includes 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, and distal ends of the first fastening arm 41 and the second fastening arm 42 are connected to two adjacent connecting members 1, respectively. As shown in fig. 2, when the high-stability 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 high-stability anti-reflux bracket 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 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 high-stability anti-reflux bracket through the catheter, the connecting block 14 is connected with a 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 high stability anti-reflux stent is in a deployed state: the click end 5 extends gradually from its distal end to its proximal end in a direction away from the axis of the high stability anti-reflux stent, the click end 5 having an angle of flaring relative to the axis of the high stability anti-reflux stent of between 6 ° -14 °.

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 high-stability 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 disposed at intervals, distributed along the circumference of the high-stability anti-reflux bracket, as an alternative.

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 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 high-stability anti-reflux bracket 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 contracted high-stability anti-reflux stent 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 to 3, the high-stability anti-reflux bracket 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 reinforcement 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 high-stability anti-reflux bracket is improved, and the deformation degree of the high-stability anti-reflux bracket 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 disposed between any two adjacent fasteners 4, i.e., the high stability anti-reflux bracket 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 opening towards the high-stability 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 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 high-stability anti-reflux bracket, 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 high stability anti-reflux stent, 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 high stability 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 high stability 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.

The embodiment of the utility model also provides a prosthetic valve device, which comprises the high-stability anti-reflux bracket provided by any embodiment, wherein the reflux bracket forms an installation channel, the prosthetic valve device further comprises a covering film, prosthetic valve leaves and a leakage-proof skirt edge, the covering film is fixed on the fastening piece 4, and the covering film is arranged around the inner side of the high-stability anti-reflux bracket in a circle and is used for preventing blood from leaking laterally through the hollowed-out position of the high-stability anti-reflux bracket; the artificial valve leaflet is fixed on the tectorial membrane, and further the distal end both sides fixed mounting of artificial valve leaflet is in the sewing part 13 of connecting piece 1, the edge of the distal end of artificial valve leaflet directly passes through the sewing through hole 131 of rectangular shape promptly and sews up, need not to increase and sew up the gasket, the mode of fixing artificial valve leaflet with the mutual extrusion of reverse flow support is used to the gasket relatively tradition, at first reduced the additional spare part of high stability anti reverse flow support, and no gasket has also been favorable to the further compression of high stability anti reverse flow support, if there is the gasket, not only influence the support compression, can damage artificial valve leaflet even sometimes under the less condition of support compression size. The leak-proof skirt edge is arranged at the near center end of the clamping end 5 and used for preventing the side leakage of the high-stability anti-reflux bracket.

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 high stability anti-reflux stent comprising:

2. The high stability anti-reflux bracket of claim 1, wherein the V-shaped auxiliary portion comprises a first auxiliary arm, a second auxiliary arm, and an auxiliary portion distal end, the first auxiliary arm and the second auxiliary arm being connected by the auxiliary portion distal end.

3. The high stability anti-reflux bracket of claim 2, wherein the distal end of the first auxiliary arm is curved toward its corresponding second auxiliary arm when the high stability anti-reflux bracket is in a deployed state; the distal end of the second auxiliary arm is bent towards the direction of the corresponding first auxiliary arm;

and/or the number of the groups of groups,

4. The high stability anti-reflux bracket of claim 1, wherein the positioning member comprises a first positioning arm, a second positioning arm, and a positioning member proximal end, the first positioning arm and the second positioning arm being connected by the positioning member proximal end; the two ends of the auxiliary piece are respectively connected with the first positioning arm and the second positioning arm.

5. The high stability anti-reflux bracket of claim 4,

in the axial direction of the high-stability 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;

6. The high stability anti-reflux bracket of claim 5, further comprising a securing member, wherein a proximal end of the securing member is coupled to the positioning member, and wherein the marking member is coupled to the securing member.

7. The high stability anti-reflux bracket according to claim 6, 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 is at least partially protruded from the surface of the fixing plate, and the marking member is at least partially located on the fixing plate.

8. The high stability anti-reflux bracket of claim 7, wherein:

the fixing piece gradually approaches to the axis of the high-stability anti-reflux bracket from the proximal end to the distal end;

the stay wire penetrating hole is formed in the distal end of the fixing piece.

9. The high stability anti-reflux bracket of claim 6, wherein the marker is C-shaped and is disposed through from a proximal end to a distal end thereof, the marker being disposed around the fixation member between the proximal and distal ends thereof;

10. The high stability anti-reflux bracket of claim 1, wherein the fastener comprises a first fastening arm, a second fastening arm, and a fastener proximal end connecting the first fastening arm and the second fastening arm, the first fastening arm and the second fastening arm respectively connecting two adjacent connectors.

11. The high stability anti-reflux bracket of claim 1,

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 width of the web is smaller than the width of the connecting block.

12. The high stability anti-reflux bracket of claim 8, further comprising a detent end provided at a proximal end of the fastener, the high stability anti-reflux bracket being anchored in an installation environment by the detent end;

13. The high stability anti-reflux bracket of claim 12,

the reinforcing mesh further comprises a second self-expanding arc and a third self-expanding arc, wherein the second self-expanding arc and the corresponding third self-expanding arc are distributed along the axial direction of the high-stability anti-reflux bracket or along the circumferential direction of the high-stability anti-reflux bracket.

14. The high stability anti-reflux bracket of claim 13, wherein:

the number of the connecting pieces is three;

each positioning piece is provided with one auxiliary piece;

15. A prosthetic valve device, comprising:

the high stability anti-reflux bracket of any one of claims 1-14, the reflux bracket forming a mounting channel;

a cover film secured to the fastener;

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