CN219307044U - Tricuspid replacement valve with controllable barbs - Google Patents

Abstract

The utility model belongs to the technical field of medical appliances, and particularly relates to a double-layer tricuspid valve replacement valve. A controllable barbed tricuspid replacement valve comprising: a bracket mechanism having an outer frame; the barbs are uniformly arranged on the peripheral surface of the outer frame along the circumferential direction; a barb opening is formed between the barb and the outer frame toward the inflow end, the barb having: the connecting end is connected with the outer frame; and the free end is connected with the connecting end and is provided with a stay wire hole. According to the utility model, the pulling wire hole arranged at the free end of the barb can be penetrated by the control pulling wire, and the barb is opened for a large angle and kept for a long time by the control pulling wire, so that the barb can have more opportunities to catch the tricuspid valve primary valve leaflet.

Description

Tricuspid replacement valve with controllable barbs

Technical Field

The utility model belongs to the technical field of medical appliances, and particularly relates to a double-layer tricuspid valve replacement valve.

Background

Tricuspid regurgitation is generally caused by pulmonary hypertension and right ventricular enlargement, and can cause symptoms such as hypodynamia, abdominal distension, ascites, inappetence, nausea and vomiting, hepatomegaly and pain. But also the heart of the patient will expand and the function of the heart will be reduced accordingly. Thus, there is a need for timely administration of medication, and for tricuspid valve replacement, if necessary, to the patient.

Because the tricuspid valve is positioned irregularly or because of the difference between the right atrium and the right ventricle and the heart beating, it is difficult to directly select a single-layer valve support for tricuspid valve replacement. Therefore, a double-layer stent is generally required, the outer-layer stent is used for being attached to the inner wall of the heart and bearing the deformation generated by the heart contraction, and the inner-layer stent inside the outer-layer stent provides a stable working environment for the artificial valve leaflet.

Conventionally, barbs are typically provided on the stent of the tricuspid replacement valve to secure the stent. In performing the procedure, the barbs are typically formed in a relatively straight shape turned 180 degrees and compressed with the stent for delivery within the delivery system. The barbs gradually evert capturing the tricuspid native valve leaflets as the inflow end of the tricuspid replacement valve is released. However, since the tricuspid native valve leaflet of the heart is soft and movable, the barbs are not specific when capturing the tricuspid native valve leaflet, and it is not clear what specific state the tricuspid native valve leaflet is in, and it is necessary to accurately grasp the barb capturing timing. However, when a plurality of barbs are needed to capture three native valve leaflets respectively, the barbs are turned over synchronously to capture the three native valve leaflets in the process of releasing the barbs or in the process of releasing the outflow end of the stent, and as the specific states of the three native valve leaflets are not identical, it is difficult to ensure that all the barbs capture all the native valve leaflets.

Accordingly, there is a need for a tricuspid replacement valve that overcomes the above-described problems.

Disclosure of Invention

The utility model aims at the technical problem that a plurality of barbs cannot capture a plurality of primary valve leaflets at the same time in the stent release process, and aims to provide a tricuspid valve replacement valve with controllable barbs.

A controllable barbed tricuspid replacement valve comprising:

a bracket mechanism having an outer frame;

the barbs are uniformly arranged on the peripheral surface of the outer frame along the circumferential direction;

a barb opening is formed between the barb and the outer frame and is directed to the inflow end, and the barb is provided with:

the connecting end is connected with the outer frame;

the free end is connected with the connecting end, a stay wire hole is formed in the free end, the stay wire hole allows a control stay wire to pass through, and the angle of the barb opening is controlled through the control stay wire.

Preferably, the barb comprises:

the barb device comprises two barb rods, wherein one ends of the barb rods are folded inwards from an outflow end to an inflow end and then spread outwards, and then are connected smoothly to form a reverse V-shaped free end with a corner being a round angle, the other ends of the barb rods are bent inwards to the inflow end and are respectively connected with the outer peripheral surface of an outer frame to form a connecting end, so that the barb forms a barb opening, and the barb opening has a necking structure and an outward spreading structure which are in smooth transition from the outflow end to the inflow end.

Preferably, the outer frame includes:

an outer frame body, which is a hollow cylinder-like structure formed by a plurality of outer frame grids;

the outer frames are connected with the inner frames through the outer connecting blocks;

the outflow end of the barb in the compressed state does not exceed the outflow end of the outer connecting block.

Preferably, the barb is a curved rod, the curved rod including the connecting end, a curved portion and the free end, the curved portion and the free end forming the barb opening.

Preferably, the width of the bar from the bending portion to the free end is larger than the width of the bar from the bending portion to the connecting end.

Preferably, the width of the rod from the bending part to the free end is equal to the width of the rod from the bending part to the connecting end, and a stabilizing plate is arranged on the bending rod between the bending part and the free end, and the width of the stabilizing plate is larger than the width of the rod of the bending rod.

Preferably, the shape of the stabilizing plate may be rectangular, semicircular, circular, crescent or the like.

Preferably, the stabilizer plate is one or more, and the stabilizer plate is arranged at any position between the bending part and the free end.

Preferably, when the stabilizer plate is one, one stabilizer plate is located at a position between the free end portion or the bent portion to the free end.

Preferably, when the number of the stabilizing plates is plural, the plurality of stabilizing plates are uniformly distributed.

Preferably, when the stabilizer plate is provided in plurality, the distance between adjacent stabilizer plates is smaller from the bending portion to the free end direction.

Preferably, the bending portion is provided with a bending block, and the width of the bending block is larger than the rod width of the bending rod.

The utility model has the positive progress effects that: the tricuspid replacement valve with the controllable barbs has the following advantages:

1. the stay wire hole arranged at the free end of the barb can be penetrated by a control stay wire, and the barb is opened for a large angle and kept for a long time by the control stay wire, so that the barb can have more opportunities to catch the tricuspid valve primary valve leaflet. Even if the barb is caught and fails, the control stay wire can be used for opening the barb again to catch the tricuspid valve primary valve leaflet again. Each barb of the utility model can independently control the opening and closing of the barb opening through the independent control stay wire, and can be opened at different angles and kept for different times. Thus effectively coping with the differences of the three leaflets of the tricuspid native leaflet. The required barb opening angle or time is different, so that the tricuspid valve replacement valve can catch all tricuspid valve primary valve leaflets or can catch all tricuspid valve primary valve leaflets, and the stability of the tricuspid valve replacement valve in a human body is improved. Meanwhile, for operators, the fault tolerance of the tricuspid valve replacement valve in capturing the tricuspid valve primary valve leaflet is improved, repeated capturing of the tricuspid valve primary valve leaflet can be realized, different barb adjustments can be actively made according to the change of the tricuspid valve primary valve leaflet, the tricuspid valve primary valve leaflet can not be captured only after moving to a required position, the operation difficulty of the tricuspid valve replacement operation is greatly reduced, the operation time is shortened, and therefore the injury of the operation to a human body is reduced.

2. The barbs may take two different configurations. When the barb structure that two barb poles formed, the mid portion that two barb poles are connected does not have the fixed point, so when compressing the barb, the barb pole can be because of not too much fixed constraint point consequently take place to warp easily, if the barb pole overlength, probably take place the barb pole under compression state, interfere with outer connecting block to make the barb cover on outer connecting block, and can't expand and open. Through the mode that barb is not exceeding outer connecting block outflow end at compressed state's outflow end, even barb pole takes place to warp, also can't overlap on outer connecting block. When the barb adopts an independent bending rod structure, compared with the design adopting two barb rods, the barb transition interference problem during compression is avoided in the conveying process. In the compressed state, no matter whether the outflow end of the bending rod exceeds the outflow end of the outer connecting block, the phenomenon that the bending rod is sleeved on the outer connecting block can not occur.

3. In order to increase the contact area between the bending rod and the tricuspid native valve leaflet, the rod width from the bending part to the free end of the bending rod is larger than the rod width from the bending part to the connecting end, so that the contact area between the bending part to the free end part and the tricuspid native valve leaflet is increased, and the stability of the barb clamping the tricuspid native valve leaflet is further increased. In order to reduce the weight of the bending rod, the bending rod may be designed to have equal rod widths, and a stabilizing plate is required to be arranged on the bending rod between the bending part and the free end, so that the contact area between the bending part and the free end part and the tricuspid native valve leaflet is increased, and the stability is increased. When there are a plurality of stabilizer plates designed, a non-uniform distribution design is adopted, that is, the distance between adjacent stabilizer plates in the direction from the bending part to the free end is smaller and smaller, because when the bending rod clamps the tricuspid native valve leaflet, the free end is farthest from the bending part, and therefore the clamping force is relatively smaller relative to the part close to the bending part, so that the free end is provided with the stabilizer plates with relatively higher density, the combination area of the free end and the tricuspid native valve leaflet can be increased, and the stability of the bending rod clamping the tricuspid native valve leaflet is increased. Meanwhile, the number density of the stabilizing plates of the bending part is small, the contact area between the bending part and the tricuspid valve primary valve leaflet is reduced, and the tricuspid valve primary valve leaflet is relatively soft, so that the bending part is beneficial to sinking into the tricuspid valve primary valve leaflet to a certain extent (namely, the tricuspid valve primary valve leaflet is concavely deformed), the free end is further attached to the tricuspid valve primary valve leaflet, otherwise, if the tricuspid valve primary valve leaflet at the bending part is particularly thick, the stabilizing plates are too much, the bending part cannot sink into the tricuspid valve primary valve leaflet due to the overlarge contact area, and the free end is possibly caused to be warped, so that the free end cannot play the function of clamping the tricuspid valve primary valve leaflet. In order to increase the bending force of the bending rod, a bending block is added to the bending part, so that after the bending part is bent, the bending part can provide larger bending holding force, and the bending rod is beneficial to clamping the tricuspid native valve leaflet.

Drawings

FIG. 1 (a) is a perspective view of the present utility model;

FIG. 1 (b) is an enlarged view of a portion of FIG. 1 (b);

FIG. 1 (c) is a schematic illustration of an application of FIG. 1 (a);

FIG. 2 (a) is a schematic view of the outer frame of FIG. 1 (a) in a compressed state;

fig. 2 (b) is a partial enlarged view of fig. 2 (a);

FIG. 3 (a) is a schematic view of the outer frame of FIG. 1 (a) in another compressed state;

FIG. 3 (b) is an enlarged view of a portion of FIG. 3 (a);

FIG. 4 (a) is a diagram of one implantation procedure of the tricuspid replacement valve of FIG. 1 (a);

FIG. 4 (b) is another implantation process diagram of the tricuspid replacement valve of FIG. 1 (a);

FIG. 5 (a) is another perspective view of the present utility model;

FIG. 5 (b) is a schematic view of the outer frame of FIG. 5 (a) in a compressed state;

fig. 5 (c) is a partial enlarged view of fig. 5 (b);

FIG. 6 (a) is a schematic view of an alternative compression state of the outer frame of the present utility model;

fig. 6 (b) is a partial enlarged view of fig. 6 (a);

FIG. 7 (a) is a schematic view of an alternative compression state of the outer frame of the present utility model;

fig. 7 (b) is a partial enlarged view of fig. 7 (a);

FIG. 8 (a) is a schematic view of an alternative compression state of the outer frame of the present utility model;

fig. 8 (b) is a partial enlarged view of fig. 8 (a).

Detailed Description

In order that the manner in which the utility model is practiced, as well as the features and objects and functions thereof, will be readily understood and appreciated, the utility model will be further described in connection with the accompanying drawings.

In the present utility model, "distal", "proximal", "distal" and "proximal" are used as terms of orientation which are conventional in the art of interventional medical devices, wherein "distal" refers to the end or segment of the procedure that is distal to the operator and "proximal" refers to the end or segment of the procedure that is proximal to the operator. "axial" refers to a direction parallel to the line connecting the distal center and the proximal center of the medical device; "radial" refers to a direction perpendicular to the "axial" direction described above.

When describing a barbed tricuspid replacement valve, the "inflow end" refers to the side of the barbed tricuspid replacement valve that allows blood inflow, and also the side distal to the apex, and correspondingly, the "outflow end" refers to the side of the barbed tricuspid replacement valve that allows blood outflow, and also the side proximal to the apex.

Referring to fig. 1 (a) and 1 (b), an embodiment of the present utility model provides a tricuspid replacement valve with controllable barbs, comprising a stent mechanism having an outer frame 100 and a plurality of barbs 400, wherein the plurality of barbs 400 are uniformly circumferentially disposed on the outer circumferential surface of the outer frame 100, and barb openings 410 are formed between the barbs 400 and the outer frame 100 toward the inflow end. The barb 400 comprises a connecting end 401 and a free end 402, the connecting end 401 is connected with the outer frame 100, the free end 402 is connected with the connecting end 401, a stay wire hole 403 is arranged on the free end 402, the stay wire hole 403 allows a control stay wire to pass through, and the angle of the barb opening is controlled by controlling the stay wire.

This embodiment opens the barb 400 through a large angle and remains for a long period of time by controlling the pull-wire so that the barb 400 has more opportunities to catch the tricuspid native valve leaflet. Even if the barb 400 fails to catch, the control pull wire can be used to reopen the barb 400 and recapture the tricuspid native valve leaflet. Each barb 400 of this embodiment can independently control opening and closing of the barb 400 opening by its independent control stay wire, and can be opened at different angles at different times, and keep different times. Thus effectively coping with the differences of the three leaflets of the tricuspid native leaflet. The required opening angle or time of the barbs 400 is different, so that the tricuspid replacement valve can catch all tricuspid native valve leaflets, or the tricuspid replacement valve can catch all tricuspid native valve leaflets, and the stability of the tricuspid replacement valve in a human body is improved. Meanwhile, for operators, the fault tolerance of the tricuspid valve replacement valve in capturing the tricuspid valve primary valve leaflet is improved, repeated capturing of the tricuspid valve primary valve leaflet can be realized, different barbs 400 can be actively adjusted according to the change of the tricuspid valve primary valve leaflet, the tricuspid valve primary valve leaflet can not be captured only after moving to a required position, the operation difficulty of the tricuspid valve replacement operation is greatly reduced, the operation time is shortened, and the harm of the operation to a human body is reduced.

In this embodiment, referring to fig. 1 (c), the barb-controllable tricuspid replacement valve generally further comprises a covering mechanism having an outer frame covering 300, the outer frame covering 300 being wrapped over the outer frame 100, and a plurality of barbs 400 extending from the outer frame covering 300.

In this embodiment, the barbed tricuspid replacement valve generally further comprises an inner frame and leaflet mechanism, the inner frame generally disposed within and connected to the outer frame 100. The valve leaf mechanism is positioned in the inner frame, and the valve leaf mechanism has a function similar to a one-way valve, so that the backflow phenomenon can be well avoided.

In this embodiment, referring to fig. 1 (a) to 1 (c), the barb 400 includes two barb rods 420, one ends of the two barb rods 420 are folded inwards from the outflow end to the inflow end and then spread outwards, and then smoothly connected to form a V-shaped free end 402 with rounded corners, and a pull wire hole 403 is provided at the V-shaped free end 402. The other ends of the two barb bars 420 are bent inward toward the inflow end and are respectively connected with the outer circumferential surface of the outer frame 100 to form the connection end 401, so that the barbs 400 form barb openings 410, and the barb openings 410 respectively have a smoothly transitional necking structure and an expanding structure from the outflow end to the inflow end. The two barb bar 420 design, when the outer frame 100 is released, the tricuspid native valve She Keka is in the barb opening 410 between the barb 400 and the outer frame 100, after the outer frame 100 is completely released, the barb 400 is pressed by the outer frame 100 against the right ventricular wall. The anchoring by the barbs 400 reduces damage to the tissue by the outer frame 100. The resistance of the leaflet mechanism to the stent mechanism, as well as the frictional force between the stent mechanism and the right ventricular wall, counteracts the upward thrust of the stent mechanism by the pressure in the right ventricle through the barbs 400 as the right ventricle contracts. The necked down configuration of the barb 400 may increase the clamping force between the barb 400 and the leaflet. The flared structure of barb 400 increases friction with the right ventricle wall and the flared end is arcuate to avoid puncturing the right ventricle wall.

In the present embodiment, the outer frame 100 includes an outer frame body 110 and a plurality of outer connection blocks 130, and the outer frame body 110 is a hollow cylinder-like structure formed of a plurality of outer frame meshes. The plurality of outer connection blocks 130 are uniformly connected to the outflow end of the outer frame body 110 in the circumferential direction. The outer frame 100 is connected to the inner frame through an outer connection block 130.

Referring to fig. 2 (a) and 2 (b), the outflow end of barb 400 in the compressed state (i.e., the free end when expanded) exceeds the outflow end of outer connection block 130.

Preferably, referring to fig. 3 (a) and 3 (b), the outflow end of barb 400 in the compressed state does not exceed the outflow end of outer connector block 130. The barb 400 requires straightening the barb 400 during delivery of the tricuspid replacement valve, as shown in fig. 2 (a) and 3 (a), with the free end 402 of the barb 400 turned 180 degrees to form a relatively straight shape for compression. When the barb structure that two barb poles formed, the mid portion that two barb poles are connected does not have the fixed point, so when compressing the barb, the barb pole can be because of not too much fixed constraint point consequently take place to warp easily, if the barb pole overlength, probably take place the barb pole under compression state, interfere with outer connecting block to make the barb cover on outer connecting block, and can't expand and open. Through the mode that barb is not exceeding outer connecting block outflow end at compressed state's outflow end, even barb pole takes place to warp, also can't overlap on outer connecting block.

In this embodiment, the inner frame further includes an inner frame body and a plurality of inner connection blocks, and the plurality of inner connection blocks are uniformly connected to the outflow end of the inner frame body along the circumferential direction. The inner frame is connected with the outer connecting block through the inner connecting block to realize that the inner frame is connected in the outer frame. Referring to fig. 1 (c), the outer connection block 130 and the inner connection block are both an outflow end folding structure folded toward the outflow end. The folding angle of the folding structure of the outflow end is alpha, and alpha is more than or equal to 45 degrees and less than or equal to 75 degrees. The excessive folding angle affects the endothelialization speed of the outflow end of the outer frame main body 110 or the outflow end of the inner frame, so that the proper folding angle can meet the endothelialization speed and protect the inner wall of the heart from being punctured due to collision of the inflow ends of the outer connecting blocks 130 or the inner connecting blocks.

In this embodiment, the outer connection block 130 and the inner connection block adopt connection blocks of the same structure, the connection blocks have two connection through holes, and the outflow end faces of the connection blocks are arc faces. That is, the outer connection block 130 has two connection through holes, the outflow end face of the outer connection block 130 is an arc face, the inner connection block has two connection through holes, and the outflow end face of the outer connection block is an arc face. The outflow terminal surface of connecting block reduces the damage risk to the right ventricle for the arcwall face.

In the present embodiment, referring to fig. 1 (c), the outer frame body 110 includes an atrial gathering section 111, an atrial clamping section 112, an annular clamping section 113, and a ventricular fixing section 114 from an inflow end to an outflow end. The atrial gathering section 111 is an inflow end gathering structure that gathers toward the inflow end. The atrial clamping section 112 is an outward expansion structure which expands outward toward the inflow end, and the inflow end of the atrial clamping section 112 is smoothly connected with the outflow end of the atrial gathering section 111. The annular clamping section 113 is a hollow straight cylinder, and the inflow end of the annular clamping section 113 is smoothly connected with the outflow end of the atrial clamping section 112. The ventricular fixing section 114 is a hollow straight cylinder, the inflow end of the ventricular fixing section 114 is smoothly connected with the outflow end of the annular clamping section 113, and the outflow end of the ventricular fixing section 114 is folded and connected with the inflow end of the outer connecting block 130. Through the multistage design of different structures, make outer frame main part 110 after placing in the internal, different positions realize different functions. If the atrial furling section 111 is fixed to the atrial side after the outer frame body 110 is released in vivo, the inflow-end furling structure can avoid damaging the inner wall of the atrium. The atrial clamping section 112 of the flaring structure can be well clamped on the atrial side to achieve the atrial side fixation. The hollow straight cylinder-like annulus clamping section 113 clamps the native valve leaflet. The ventricular securing section 114 is adapted to be secured to the ventricular side.

In this embodiment, referring to FIG. 1 (c), the inflow end gather structure gathers at an angle β,10 β 45. Too large a folding angle affects the endothelialization speed of the inflow end of the atrial folding section 111, so that the proper folding angle can meet the endothelialization speed and protect the inner wall of the heart from being punctured by collision of the inflow end of the atrial folding section 111.

In this embodiment, the outer frame body 110 includes several layers of hollow polygonal frames surrounded by outer frame support bars, the polygonal frames having polygonal mesh openings. The cross section of the outer frame support rod extends from the annular clamping section 113 to the inflow end in an S shape.

The polygonal frame may be a diamond frame with diamond meshes or a hexagon frame with hexagon meshes. As shown in fig. 1 (c), the outer frame main body 110 is an upper and lower polygonal frame surrounded by outer frame support bars, and the radial directions of the polygonal frames are connected by outer frame connection columns. The two layers of polygonal frames are heat-set to form the outer frame body 110.

In this embodiment, the inner walls of the inflow end and the outflow end of the polygonal frame surrounded by the outer frame support rods are arc-shaped inner walls, and the outer wall of the inflow end of the polygonal frame surrounded by the outer frame support rods is an arc-shaped outer wall. The radial inner walls of the polygonal frame surrounded by the outer frame support rods are arc-shaped inner walls.

In this embodiment, the minimum diameter of the atrial gathering section 111 is D1, the maximum diameter of the atrial clamping section 112 is D2, and the diameter of the ventricular fixing section 114 is D3, then:

D1：D2：D3＝1：1.05～1.2：0.8～0.95。

referring to fig. 1 (a) and 1 (c), the diameters of the annular clamping section 113 and the ventricular fixing section 114 are the same in terms of spatial distribution, that is, the diameter of the annular clamping section 113 is also D3, so that the diameter ratio of D1, D2 and D3 is defined, that is, the diameter ratio among the annular clamping section 113, the atrial gathering section 111 and the atrial clamping section 112 is defined.

In this embodiment, referring to fig. 1 (c), the inflow end of the outer frame body 110 is further provided with a plurality of recovery parts 120, and the recovery parts 120 are recovery rings or recovery hooks. The recovery portion can be fitted with a suitably configured snare to effect positional adjustment or recovery of the implanted double-layer tricuspid replacement valve.

Referring to fig. 5 (a) to 5 (c), an embodiment of the present utility model provides a tricuspid replacement valve with controllable barbs, which has a different configuration of barbs 400 than the embodiment of fig. 1 (a), and the remaining configurations are identical.

In this embodiment, the barb 400 is a bending rod 430, and the bending rod 430 includes a connection end 401, a bending portion 431 and a free end 402, wherein the connection end 401 is connected to the outer frame 100, the bending portion 431 and the free end 402 form a barb opening 410, and a pulling wire hole 403 is provided at the free end 402. When barb 400 is constructed with a single bending rod 430, the barb transition interference problem during compression is avoided during delivery, as compared to the two barb rod 420 design. In the compressed state, the outflow end of bending rod 430 may not exceed the outflow end of outer connection block 130, and as shown in fig. 5 (b), the phenomenon that bending rod 430 is sleeved on outer connection block 130 does not occur regardless of whether the outflow end of bending rod 430 exceeds the outflow end of outer connection block 130.

In this embodiment, referring to fig. 5 (b), the width of the bent portion 431 to the free end 402 is equal to the width of the bent portion 431 to the connection end 401, and the stabilizer plate 432 is provided on the bent rod 430 between the bent portion 431 to the free end 402, and the width of the stabilizer plate 432 is larger than the width of the bent rod 430. In order to reduce the weight of bending bar 430, bending bar 430 may also be designed to have equal bar widths, and in this case, stabilizer plate 432 is required to be disposed on bending bar 430 between bending portion 431 and free end 402, so as to increase the contact area between the portion from bending portion 431 to free end 402 and the tricuspid native valve leaflet, and increase stability.

In this embodiment, the shape of the stabilizing plate 432 may be rectangular, semicircular, circular, crescent, or the like. The stabilizing plate 432 is crescent shaped as shown in fig. 5 (c).

In this embodiment, the stabilizing plates 432 are one, with one stabilizing plate 432 being located at a position between the end of the free end 402 or the bent portion 431 to the free end 402. Referring to fig. 5 (b), a stabilizing plate 432 is located at the end of the free end 402.

Referring to fig. 6 (a) and 6 (b), an embodiment of the present utility model provides a tricuspid replacement valve with controllable barbs that uses a different number of stabilizing plates 432 than the embodiment of fig. 5 (a) and 5 (b), with the remaining structure being the same.

In the present embodiment, the stabilizing plates 432 are plural, and the stabilizing plates 432 are provided at any position between the bent portion 431 and the free end 402.

In the present embodiment, when the stabilizing plates 432 are plural, the plurality of stabilizing plates 432 are uniformly distributed. Preferably, as shown in fig. 6 (a) and 6 (b), when there are a plurality of stabilizing plates 432, the distance between adjacent stabilizing plates 432 becomes smaller from the bent portion 431 toward the free end 402.

When there are a plurality of stabilizing plates 432 designed, a non-uniform distribution design is adopted, that is, the distance between the bending portion 431 and the adjacent stabilizing plates 432 in the direction of the free end 402 is smaller and smaller, because the free end 402 is farthest from the bending portion 431 when the bending bar 430 clamps the tricuspid native valve leaflet, and thus the clamping force is relatively smaller with respect to the portion near the bending portion 431, the free end 402 is provided with the stabilizing plates 432 having a relatively larger density, so that the bonding area of the free end 402 and the tricuspid native valve leaflet can be increased, thereby increasing the stability of the bending bar 430 clamping the tricuspid native valve leaflet. Meanwhile, the small number density of the stabilizing plates 432 of the bending portion 431 is beneficial to reducing the contact area between the bending portion 431 and the tricuspid valve primary leaflet, and the tricuspid valve primary leaflet is relatively soft, so that the bending portion 431 is beneficial to sinking into the tricuspid valve primary leaflet to a certain extent (namely, the tricuspid valve primary leaflet is concavely deformed), and therefore the free end 402 is promoted to be more attached to the tricuspid valve primary leaflet, otherwise, if the tricuspid valve primary leaflet at the bending portion 431 is particularly thick, the stabilizing plates 432 are too much, and the bending portion 431 cannot sink into the tricuspid valve primary leaflet due to the overlarge contact area, so that the free end 402 can not play a role in clamping the tricuspid valve primary leaflet.

Referring to fig. 7 (a) and 7 (b), an embodiment of the present utility model provides a tricuspid replacement valve with controllable barbs, which is different in configuration at the curved portion 431 and identical in configuration to the embodiment of fig. 5 (a) and 5 (b).

In the present embodiment, the bending portion 431 is provided with a bending block 433, and the width of the bending block 433 is larger than the rod width of the bending rod 430. To increase the bending force of bending bar 430, bending block 433 is added to bending portion 431, so that bending portion 431 can provide a greater bending retention force after bending, facilitating the clamping of tricuspid native valve leaflet by bending bar 430.

Referring to fig. 8 (a) and 8 (b), an embodiment of the present utility model provides a tricuspid replacement valve with controllable barbs, which has a different stem width configuration of curved stem 430 than the embodiment of fig. 5 (a) and 5 (b), and no stabilizing plates 432 are provided, the remaining configurations being identical.

In the present embodiment, the rod width of the bent portion 431 to the free end 402 is larger than the rod width of the bent portion 431 to the connection end 401. In order to increase the contact area of the bending rod 430 with the tricuspid native valve leaflet, the rod width of the bending portion 431 to the free end 402 of the bending rod 430 is greater than the rod width of the bending portion 431 to the connecting end 401, thereby increasing the contact area of the portion of the bending portion 431 to the free end 402 with the tricuspid native valve leaflet, thereby further increasing the stability of the barb 400 gripping the tricuspid native valve leaflet.

The barbed tricuspid replacement valve provided by the embodiment of fig. 1 (a) through 1 (c), the barbed tricuspid replacement valve provided by the embodiment of fig. 5 (a) through 5 (c), the barbed tricuspid replacement valve provided by the embodiment of fig. 6 (a) through 6 (b), the barbed tricuspid replacement valve provided by the embodiment of fig. 7 (a) through 7 (b), and the barbed tricuspid replacement valve provided by the embodiment of fig. 8 (a) through 8 (b) of the present utility model may all be implanted into the human body using a transapical approach, as exemplified by the barbed tricuspid replacement valve provided by the embodiment of fig. 1 (a) through 1 (c):

when the barbed tricuspid replacement valve is advanced into the heart by transapical means, i.e., the operative end is proximal to the ventricular side, the interior of the stent mechanism is penetrated by the inner tube 920, the inflow end of the stent mechanism is closed using the distal end of the inner tube 920, and may be connected to or disconnected from the inner frame, and the outflow end of the stent mechanism is closed by the distal end of the outer tube 910. The outflow end of the stent mechanism is released by first retracting the outer tube 910, and the control wire 930 is also extended from the distal end of the outer tube 910 of the delivery system (the end where the outflow end of the valve is fixed) to the free end of the detachable connection barb 400, as shown in fig. 4 (a), and the barb opening 410 of the barb 400 is controlled to be opened by the control wire 930, so that the barb 400 captures the native valve leaflet of the tricuspid valve smoothly. The distal end of inner tube 920 then releases the inflow end of the stent mechanism, thereby completing implantation of the stent mechanism.

The barbed tricuspid replacement valve provided by the embodiment of fig. 1 (a) through 1 (c), the barbed tricuspid replacement valve provided by the embodiment of fig. 5 (a) through 5 (c), the barbed tricuspid replacement valve provided by the embodiment of fig. 6 (a) through 6 (b), the barbed tricuspid replacement valve provided by the embodiment of fig. 7 (a) through 7 (b), and the barbed tricuspid replacement valve provided by the embodiment of fig. 8 (a) through 8 (b) of the present utility model may be implanted in the human body using a transfemoral/transjugular approach, as exemplified by the barbed tricuspid replacement valve provided by the embodiment of fig. 1 (a) through 1 (c):

upon transfemoral/transcervical access to the heart, i.e., with the operative end proximal to the atrial side, the stent mechanism is internally penetrated by an inner tube 920 and the outer tube 910 collapses the entire stent mechanism. First, the outflow end of the stent mechanism is released by the retreating of the outer tube 910, as shown in fig. 4 (b), the control pull wire 930 of which is extended from the distal end of the inner tube 920 of the delivery system and detachably connected to the free end of the barb 400, so that the barb opening 410 of the barb 400 is controlled to open to catch the tricuspid native valve leaflet by pulling back the control pull wire 930. After the capture of the tricuspid native leaflets is completed, the outer tube 910 continues to retract releasing the inflow end of the stent mechanism, at which point the inflow end of the outer frame 100 is fully released and conforms to the inner wall of the heart, withdrawing the delivery system. Generally, the inner tube 920 and the control wire 930 may be withdrawn later than the inflow end of the outer frame 100, because the control wire 930 connected to the stent mechanism through the inner tube 920 plays a role of stabilizing the stent mechanism when the inflow end of the outer frame 100 is released, and the stability of the stent mechanism is increased when the inflow end of the stent mechanism is released, thereby completing the implantation process of the whole stent mechanism.

The foregoing has shown and described the basic principles, principal features and advantages of the utility model. It will be understood by those skilled in the art that the present utility model is not limited to the embodiments described above, and that the above embodiments and descriptions are merely illustrative of the principles of the present utility model, and various changes and modifications may be made without departing from the spirit and scope of the utility model, which is defined in the appended claims. The scope of the utility model is defined by the appended claims and equivalents thereof.

Claims (10)

1. A controllable barbed tricuspid replacement valve comprising:

a bracket mechanism having an outer frame;

the barbs are uniformly arranged on the peripheral surface of the outer frame along the circumferential direction;

the barb opening towards the inflow end is formed between the barb and the outer frame, and the barb is provided with:

the connecting end is connected with the outer frame;

the free end is connected with the connecting end, a stay wire hole is formed in the free end, the stay wire hole allows a control stay wire to pass through, and the angle of the barb opening is controlled through the control stay wire.

2. The controllable barbed tricuspid replacement valve according to claim 1, wherein the barb comprises:

the barb device comprises two barb rods, wherein one ends of the barb rods are folded inwards from an outflow end to an inflow end and then spread outwards, and then are connected smoothly to form a reverse V-shaped free end with a corner being a round angle, the other ends of the barb rods are bent inwards to the inflow end and are respectively connected with the outer peripheral surface of an outer frame to form a connecting end, so that the barb forms a barb opening, and the barb opening has a necking structure and an outward spreading structure which are in smooth transition from the outflow end to the inflow end.

3. The barb-controllable tricuspid replacement valve of claim 2, wherein the outer frame comprises:

an outer frame body, which is a hollow cylinder-like structure formed by a plurality of outer frame grids;

the outer frames are connected with the inner frames through the outer connecting blocks;

the outflow end of the barb in the compressed state does not exceed the outflow end of the outer connecting block.

4. The barb-controllable tricuspid replacement valve according to claim 1, wherein the barbs employ a curved stem comprising the connecting end, a curved portion, and the free end, the curved portion and the free end forming the barb opening.

5. The barb-controllable tricuspid replacement valve according to claim 4, wherein the stem width of the bend to the free end is greater than the stem width of the bend to the connecting end.

6. The barb-controllable tricuspid replacement valve according to claim 4, wherein the stem width of the curved portion to the free end is equal to the stem width of the curved portion to the connecting end, and wherein a stabilizer plate is disposed on the curved stem between the curved portion to the free end, the stabilizer plate having a greater width than the stem width of the curved stem.

7. The barb-controllable tricuspid replacement valve of claim 6, wherein the stabilizing plate is rectangular, semicircular, circular, or crescent shaped in shape.

8. The controllable barbed tricuspid replacement valve according to claim 6 or 7, wherein the stabilizing plate is one or more, the stabilizing plate being disposed anywhere between the curved portion to the free end.

9. The barb-controllable tricuspid replacement valve according to claim 8, wherein when the stabilizing plates are one, one of the stabilizing plates is located at a position between the free end portion or the curved portion to the free end;

when the stabilizer plates are plural, the distance between adjacent stabilizer plates is smaller from the bending portion to the free end direction.

10. The barb-controllable tricuspid replacement valve of claim 4, wherein the curved portion is provided with a curved block having a width greater than a stem width of the curved stem.

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