WO2022048585A1 - Interventional venous valve stent and venous valve prosthesis - Google Patents

Abstract

An interventional venous valve stent (20, 20a), comprising a support body and a connecting scaffold (40, 40a), wherein the support body comprises a first annular support scaffold (30); the connecting scaffold (40, 40a) is connected to an end of the first annular support scaffold (30); the connecting scaffold (40, 40a) is arranged in the circumferential direction of the first annular support scaffold (30) and is broken in the circumferential direction of the connecting scaffold (40, 40a) to form a notch (401); at least part of the connecting scaffold (40, 40a) protrudes outwards to form a protruding portion (41); and a sinus region (403) is formed on an inner side of the protruding portion (41). With the notch (401), the interventional venous valve stent (20, 20a) has good flexibility, such that the interventional venous valve stent (20, 20a) can pass through a circuitous and complex blood vessel more easily to reduce operation risk; and with leaflets (74), backflow blood forms a vortex flow in the area of the sinus region (403) covered by the leaflets (74) so as to prevent a backflow of blood, thereby achieving a good clinical effect of a venous valve prosthesis (100, 100a, 100b). The venous valve prosthesis (100, 100a, 100b) provided with the interventional venous valve stent (20, 20a) is further provided.

Description

Interventional venous valve stent and venous valve prosthesis technical field

The present application relates to the technical field of implantable blood vessels, and in particular, to an interventional venous valve stent and a venous valve prosthesis provided with the interventional venous valve stent.

Background technique

Venous surgery disease is a common disease in surgery, which mostly occurs in the lower extremities. Its main clinical manifestations are varicose veins, limb swelling, and skin dystrophic lesions in the boot area, such as dermatitis, pigmentation, and ulceration. The main pathological reason is that the venous valve loses the basic function of one-way opening under the action of pathogenic factors. Mild cases of venous disease hinder the ability to live and work, and severe cases can cause different degrees of disability. Therefore, the treatment of lower extremity venous valve disease has received increasing attention. At present, most of the clinical treatment of the disease is still conservative, such as drug therapy, pressure pump, etc., and surgical treatment such as femoral vein valve repair and reconstruction, etc., the clinical effect is not ideal. Especially when the venous valve is severely damaged or the patients with congenital valveless disease, venous valve transplantation seems to be the only method of choice. The reasons for the poor anchoring force and insufficient compliance of the prosthesis after implantation in the blood vessel make the clinical effect of the venous valve prosthesis unsatisfactory. How to provide a venous valve prosthesis with good anchoring performance and good flexibility is a technical problem that needs to be solved urgently in the art.

SUMMARY OF THE INVENTION

The purpose of this application is to provide a venous valve prosthesis and an interventional venous valve stent with better clinical effects.

In order to solve the above technical problems, the present application provides an interventional venous valve stent capable of radial compression and expansion, including a support body and a connecting skeleton, the support body including a first annular support skeleton, and the connecting skeleton is connected to the The end of the first annular supporting frame, the connecting frame is arranged along the circumferential direction of the first annular supporting frame and is disconnected in the circumferential direction of the connecting frame to form a gap, and at least part of the connecting frame is outside The bulge forms a bulge, and the inner side of the bulge forms a sinus area.

The present application also provides a venous valve prosthesis for implanting into a venous blood vessel, the venous valve prosthesis includes an interventional venous valve stent and a valve assembly, the valve assembly includes a valve leaflet connected to the inner side of the connecting frame, and the The leaflet shield is disposed at least in part of the sinus region and is used to construct a one-way passage in the venous vessel.

The gap on the connecting frame of the venous valve prosthesis provided by the present application reduces the excessive expansion of the venous vessel wall by the protrusion of the connecting frame, and the gap enables the interventional venous valve stent to have better flexibility, making the interventional venous valve stent better It is easier to pass through complicated blood vessels and reduce the risk of surgery; in addition, the valve leaflets are in a suspended state under the action of the vortex and do not fit with the vein wall, which can reduce the risk of adhesion, and the formed vortex can also avoid blood at the root of the valve leaflet. Risk of thrombus formation due to flow retention; valve leaflets move toward the gap under the impact of blood backflow in the venous vessel and abut against the inner wall of the venous vessel around the gap, causing the returning blood to form a vortex in the sinus area covered by the valve leaflet, preventing blood flow Regression, and avoid the risk of thrombosis due to blood flow retention at the root of the valve leaflet; thus, the clinical effect of the venous valve prosthesis is better.

Description of drawings

In order to explain the technical solutions of the embodiments of the present application more clearly, the following briefly introduces the accompanying drawings that need to be used in the implementation manner. As far as technical personnel are concerned, other drawings can also be obtained based on these drawings without any creative effort.

1 is a schematic diagram of the use state of the venous valve prosthesis provided by the first embodiment of the present application;

2 is a schematic diagram of the anti-reflux state of the venous valve prosthesis provided by the first embodiment of the present application;

3 is a schematic three-dimensional structural diagram of a venous valve prosthesis provided by the first embodiment of the present application;

Figure 4 is a front view of the venous valve prosthesis in Figure 3;

5 is a schematic diagram of one of the use states of the venous valve prosthesis provided by the first embodiment of the present application;

6 is a schematic diagram of another use state of the venous valve prosthesis provided by the first embodiment of the present application;

Figure 7 is a left side view of the interventional venous valve stent of the venous valve prosthesis in Figure 3;

Figure 8 is a front view of the interventional venous valve stent in Figure 3;

Fig. 9 is the three-dimensional exploded structure schematic diagram of the valve assembly in Fig. 3;

Fig. 10 is a perspective assembly schematic diagram of the valve assembly in Fig. 9;

11 is a schematic three-dimensional structural diagram of a venous valve prosthesis provided by the second embodiment of the present application;

12 is a front view of the interventional venous valve stent provided by the third embodiment of the present application;

Figure 13 is a left side view of the interventional venous valve stent in Figure 12;

14 is a schematic three-dimensional structural diagram of an interventional venous valve stent provided by the fourth embodiment of the present application;

FIG. 15 is a front view of the interventional venous valve stent of FIG. 14 .

detailed description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, but not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the protection scope of the present application.

Furthermore, the following descriptions of the various embodiments refer to the accompanying drawings to illustrate specific embodiments in which the present application may be practiced. Directional terms mentioned in this application, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., only Reference is made to the directions of the accompanying drawings, therefore, the directional terms used are for better and clearer description and understanding of the present application, rather than indicating or implying that the device or element referred to must have a specific orientation, in a specific orientation construction and operation, and therefore should not be construed as limitations on this application. The term "natural state" refers to a state in which a device or element is not subject to external forces, such as tension or compression.

In the description of this application, the “proximal end” in this application refers to the end close to the heart position, and the “distal end” refers to the end away from the heart position. This definition is only for the convenience of expression and should not be construed as a limit.

Please refer to FIG. 1 and FIG. 2 together. The present application provides a venous valve prosthesis 100 for implantation in a venous blood vessel 300 for constructing a one-way passage in the venous blood vessel 300 to avoid blood backflow. Fig. 1 shows a schematic diagram of the use state of the venous valve prosthesis 100. At this time, under the impact of downstream blood flow from the proximal end to the distal end, the blood flow path of the venous valve prosthesis 100 is opened, and Fig. 2 shows the venous valve prosthesis. 100 is a schematic diagram of the anti-reflux state, at this time, under the impact of the reverse flow from the distal end to the proximal end, the blood flow path of the venous valve prosthesis 100 is closed.

Referring to FIGS. 1 to 4 , the venous valve prosthesis 100 includes an interventional venous valve stent 20 and a valve assembly 70 . The interventional venous valve stent 20 is a mesh cylinder structure and can be radially compressed and expanded. The interventional venous valve stent 20 includes a support body and a connecting frame 40, the support body includes a first annular support frame 30 and a second annular support frame 50, and the connecting frame 40 is located between the first annular support frame 30 and the second annular support frame 40. between the supporting frames 50; specifically, the first annular supporting frame 30 is connected to the proximal end of the connecting frame 40, and the second annular supporting frame 50 is connected to the distal end of the connecting frame 40, that is, the connecting frame 40 is connected to the first ring between the distal end of the annular support frame 30 and the proximal end of the second annular support frame 50 . The connecting frame 40 is arranged along the circumferential direction of the first annular supporting frame 30 and the second annular supporting frame 50, and is disconnected in the circumferential direction of the connecting frame 40 to form a gap 401, and at least part of the connecting frame 40 protrudes outward to form a protruding portion 41, the inner side of the protruding portion 41 forms a sinus region 403. Specifically, the protruding portion 41 is formed by the side wall of the connecting frame 40 being outwardly protruded away from the inner cavity of the connecting frame 40 approximately in the radial direction. It should be noted that the so-called "sinus area", that is, the area where the inner surface of the connecting frame 40 is concave, can also be understood as the area where the local inner diameter increases in the lumen enclosed by the connecting frame 40 .

The valve assembly 70 includes a valve body 72 attached to the inner side of the connecting frame 40 and a valve leaflet 74 attached to the inner side of the valve body 72 , the valve leaflet 74 covering at least a portion of the sinus region 403 . In this embodiment, the valve body 72 is attached to the inner surface of the connecting frame 40, and the valve leaflet 74 is connected to the side of the valve body 72 away from the connecting frame 40; specifically, the valve body 72 is sutured, bonded or hot-pressed to the connecting frame. 40. One edge of the valve leaflet 74 is sutured, bonded or thermally pressed to the valve body 72, so that the valve leaflet 74 and the part of the valve body 72 covered by the valve leaflet 74 enclose a V-shaped vortex accommodating space in cross-section. , the cross section is parallel to the axial direction of the intervening venous valve stent 20. It should be noted that the V-shaped cross section of the V-shaped vortex accommodating space is only a specific example, and does not constitute a The shape of the vortex accommodating space is defined, and the shape of the vortex accommodating space may be a regular geometric figure or an irregular geometric figure that can be conceived by those skilled in the art.

After the venous valve prosthesis 100 is implanted into the venous blood vessel 300, the interventional venous valve stent 20 is adhered to the intima of the venous blood vessel 300, so that the interventional venous valve stent 20 is stably anchored to the venous blood vessel 300, preventing the blood in the venous blood vessel 300 from leaking from the venous blood vessel 300. The intervening venous valve stent 20 leaks out from the intima of the venous blood vessel 300 , that is, all the blood flows in the lumen of the intervening venous valve stent 20 . Referring to FIG. 2 , when the blood in the venous blood vessel 300 flows from the distal end to the proximal end, the valve leaflet 74 moves toward the gap 401 under the impact of the blood flow, until the side of the valve leaflet 74 away from the valve body 72 and the gap around the gap 401 . The inner wall of the venous blood vessel 300 abuts, and the valve leaflet 74 closes the venous blood vessel 300 to effectively avoid blood backflow; with reference to FIG. 1 , when the blood in the venous blood vessel 300 flows from the proximal end to the distal end, the blood flow impacts the valve leaflet 74 to move away from the gap. One side of 401 moves to open the one-way passage of venous blood vessel 300 .

For further explanation, please refer to FIGS. 3 and 4 , the leaflet 74 includes a fixed edge 742 and a free edge 745 , the fixed edge 742 is fixedly connected to the valve body 72 , and the free edge 745 is freely suspended. Under the impact of blood backflow in the venous vessel 300 (as shown in FIG. 2 ), the free edge 745 can move toward the notch 401 and abut with the venous vessel wall around the notch 401 to form a one-way passage in the venous vessel 300 . Under the impact of the downstream blood flow in the venous vessel 300 (as shown in FIG. 1 ), the free edge 745 moves toward the sinus region 403 , and the free edge 745 is separated from the venous vessel wall to open a one-way passage in the venous vessel 300 .

It should be noted that, under the impact of the backflow of blood in the venous blood vessel 300, the valve leaflets 74 form an arched structure that blocks backflow. Referring to FIG. 5, there may be a small gap 404 between the free edge 745 and the venous blood vessel wall. The edge 745 does not abut against the venous vessel wall, thereby reducing the risk of adhesion of the free edge 745 to the vascular wall tissue, and the tiny gap 404 between the free edge 745 and the venous vessel wall does not affect the valve leaflet 74 to block the flow in the backflow. the vast majority. In addition, under the impact of the backflow of blood in the venous blood vessel 300 , the free edge 745 can be located not only near the area where the gap 401 is located, referring to FIG. . In other embodiments, the free edge 745 may also be located in the inner cavity enclosed and formed by the second annular supporting frame 50 , which is not limited in this application.

In the venous valve prosthesis 100 provided by the present application, a sinus area 403 is formed on the inner side of the protruding part 41 of the connecting frame 40 , and the circumferential disconnection of the connecting frame 40 forms a gap 401 ; the gap 401 reduces the metal coverage of the protruding part 41 . , reducing the excessive expansion of the venous vessel wall by the protruding portion 41 of the connecting frame 40, thereby reducing the excessive stimulation to the vascular intima. In addition, the gap 401 can make the interventional venous valve stent 20 have better flexibility, so that the interventional venous valve stent 20 can more easily pass through complicated blood vessels, thereby reducing the risk of surgery.

Secondly, when the downstream blood in the venous blood vessel 300 flows along the one-way passage ( FIG. 1 ), the sinus area 403 presses the inner wall of the venous blood vessel 300 to bulge out, thereby forming a depression in the area of the sinus area 403 covered by the valve leaflets 74 , when the blood in the venous blood vessel 300 flows in the direction shown in FIG. 1 , the depression will affect the laminar flow of the blood, so that when the blood bypasses the depression, the change of the flow velocity will cause a sudden shear stress Therefore, a vortex is formed in the area of the sinus region 403 covered by the valve leaflet 74, which is beneficial to the pressure balance of the valve leaflet 74. At this time, the free edge 745 of the valve leaflet 74 is in a suspended state under the action of the eddy current and does not fit with the vein wall, In turn, the risk of adhesion can be reduced, and the formed vortex can also avoid the risk of blood flow retention at the root of the valve leaflet 74 to form a thrombus; The inner wall of the venous blood vessel 300 abuts ( FIG. 2 ), so that the backflowing blood forms a vortex in the area of the sinus 403 covered by the valve leaflet 74 , preventing the blood from retreating, and avoiding the risk of blood flow retention at the root of the valve leaflet 74 to form a thrombus.

In addition, the interventional venous valve stent 20 is a nickel-titanium alloy mesh cylindrical stent, and the interventional venous valve stent 20 exhibits greater rigidity. After the interventional venous valve stent 20 is implanted in the venous blood vessel 300, the interventional venous valve stent 20 always maintains a fixed shape , the valve body 72 and thus the function of the valve leaflets 74 are not affected due to changes in the pressure of the venous blood vessel 300, and the first annular support frame 30 and the second annular support frame 50 have high radial support force, which can connect the interventional vein The valve stent 20 is better anchored to the venous blood vessel 300, and reduces the stimulation to the intima of the venous blood vessel 300, preventing excessive intimal hyperplasia.

In one embodiment, the connecting frame 40 is a non-closed mesh stent continuously arranged in its circumferential direction. The so-called "continuous" means that the connecting frame 40 extends continuously for a certain angle in its circumferential direction without being broken. Specifically, as shown in FIG. 7 and FIG. 8 , the connecting frame 40 includes a first wave supporting rod 43 with a sinusoidal waveform, and the first wave supporting rod 43 includes a plurality of first wave rods 430 connected end to end, at least part of the first wave rods The middle portion of 430 protrudes outward to form at least a part of the protruding portion 41 . That is, the first wave bar 430 with the outwardly protruding middle portion may form part of the protruding portion 41 , or may form the whole of the protruding portion 41 . In this embodiment, the number of the first corrugated support rods 43 is one, the first corrugated support rods 43 are arranged along the circumferential direction of the first annular support frame 30 , and the first corrugated support rods 43 are broken in the circumferential direction to form a gap 401 , the middle of each first wave rod 430 is convex.

The first wave supporting rod 43 has a first wave crest 432 close to the first annular supporting frame 30 and a first wave trough 434 far away from the first annular supporting frame 30 . Between the first wave bars 430. The connecting frame 40 further includes a plurality of first connecting rods 45 extending along the axial direction of the connecting frame 40 , and the first connecting rods 45 are arranged between the first wave crest 432 and the first annular supporting frame 30 . In this embodiment, each first wave crest 432 of the first wave supporting rod 43 is connected to a first connecting rod 45 , and the end of the first connecting rod 45 away from the first wave supporting rod 43 is connected to the first annular supporting frame 30 .

Preferably, in the direction from the end of the first connecting rod 45 close to the first annular support frame 30 to the end away from the first annular supporting frame 30, each first connecting rod 45 is gradually inclined outward to connect to the Corresponding to the first wave crest 432 , the first connecting rod 45 is formed as a part of the protruding portion 41 , that is, the first connecting rod 45 is formed as a proximal end portion of the protruding portion 41 . In this embodiment, the first connecting rod 45 includes a first vertical section 452 and a first curved section 454, the first vertical section 452 extends along the axial direction of the first annular support frame 30, and the first curved section 454 is formed by the A vertical section 452 is gradually bent outward in the direction from the first wave support rod 43 of the connecting frame 40 to connect with the corresponding first wave crest 432 , and the first curved section 454 forms a part of the protruding portion 41 , that is, the first curved section 454 forms the proximal portion of the protruding portion 41 , and the inner cavity enclosed and formed by the first vertical section 452 has an equal diameter. The first vertical section 452 does not have a convex structure and does not belong to the protruding portion 41 .

In this embodiment, the connecting frame 40 further includes a plurality of second connecting rods 46 extending along the axial direction of the connecting frame 40 . The wave valleys 434 are connected. Specifically, in the direction from the end of the second connecting rod 46 away from the first wave supporting rod 43 to the end close to the first wave supporting rod 43, each second connecting rod 46 is gradually inclined outward to Connected to the corresponding first troughs 434 , the second connecting rods 46 are formed as part of the protrusions 41 . The opposite end of the second connecting rod 46 is connected to the distal end of the second annular supporting frame 50 . Specifically, each first wave valley 434 of the first wave supporting rod 43 is connected to a second connecting rod 46 , and the end of the second connecting rod 46 away from the first wave supporting rod 43 is connected to the second annular supporting frame 50 .

Preferably, in the direction from the end of the second connecting rod 46 close to the second annular supporting frame 50 to the end far from the second annular supporting frame 50, each second connecting rod 46 is gradually inclined outward so as to be connected to the second annular supporting frame 50. Corresponding to the first trough 434 , the second connecting rod 46 is formed as a part of the protruding portion 41 , that is, the second connecting rod 46 is formed as a distal end portion of the protruding portion 41 . In this embodiment, the second connecting rod 46 includes a second vertical section 462 and a second curved section 464, the second vertical section 462 extends along the axial direction of the second annular support frame 50, and the second curved section 464 is formed by the first The direction from the two vertical sections 462 to the first corrugated support rod 43 of the connecting frame 40 is gradually curved outward to connect to the corresponding first wave valley 434 , and the second curved section 464 forms a part of the protruding portion 41 , that is, the second curved section 464 forms the distal portion of the protruding portion 41 , and the inner cavity enclosed and formed by the second vertical section 462 has an equal diameter. The first vertical section 462 does not have a convex structure and does not belong to the protruding portion 41 .

In other embodiments, the connecting frame 40 may not include the first connecting rod 45 and the second connecting rod 46 . In this case, the first wave crest 432 of the first corrugated support rod 43 may be directly connected to the first annular support frame 30 . The first wave trough 434 of a wave supporting rod 43 can be directly connected to the second annular supporting frame 50 .

In other embodiments, the number of the first wave support rods 43 is multiple, and the plurality of first wave support rods 43 are arranged along the axial direction of the connection frame 40 . The first wave crests 432 of every two adjacent first wave supporting rods 43 are connected with the corresponding first wave troughs 434 . In other embodiments, the first annular support frame 30 and the second annular support frame 50 have a grid structure, and the inner diameter of the grid surrounded by the adjacent two first wave-shaped support rods 43 is larger than that of the first annular support frame 30 and the mesh inner diameter of the second annular support frame 50 .

As shown in FIG. 7 and FIG. 8 , the first annular support frame 30 includes a plurality of second wave support rods 33 with sinusoidal waveforms, and the plurality of second wave support rods 33 are sequentially arranged along the axial direction of the first annular support frame 30 . ; Each second wave support rod 33 includes a plurality of second wave peaks 332, a plurality of second wave troughs 334, and a second wave rod 330 connecting two adjacent second wave peaks 332 and second wave troughs 334, the first Both ends of the connecting rod 45 are respectively connected to the first wave crest 432 and the second wave trough 334 ; The second trough 334 is connected by the first connecting rod 45 . Each second corrugated support rod 33 is arranged in a circle along the circumference of the first annular support frame 30 , a plurality of second corrugated support rods 33 encloses a first inner cavity 35 extending in the axial direction, and a plurality of second corrugated support rods The rods 33 form an annular grid structure, and every two adjacent second wave supporting rods 33 form a plurality of grid holes 37 .

As shown in FIG. 7 , the side of the first annular support frame 30 facing or connected to the connecting frame 40 is in a wave-like structure, and the wave-like structure is in the shape of concave-convex and convex. The bottom is a wave trough. At the gap 401 , at least one wave trough at the wave-like structure of the first annular support frame 30 is suspended. In another embodiment, continuing to refer to FIG. 7 , the side of the second annular supporting frame 50 facing or connecting to the connecting frame 40 is in a wave-like structure, and the wave is in the shape of concave-convex volts. The top is a wave crest and the bottom is a wave trough. At the gap 401 , at least one wave crest at the wave-like structure of the second annular support frame 50 is suspended.

As shown in FIG. 13 , the side of the first annular supporting frame 30 facing or connecting to the connecting frame 40 a has a wave-like structure, and the wave-like structure is in the shape of concave-convex undulations. In the viewing angle shown in FIG. 13 , the top of the wave-like structure is a wave crest and a bottom. To be a wave valley, at the notch 401, at least one wave valley at the wave-like structure of the first annular supporting frame 30 is suspended, which means that at least one wave valley is not connected to the connecting frame 40a. In another embodiment, referring to FIG. 13 , the side of the second annular supporting frame 50 facing or connecting to the connecting frame 40 a is in a wave-like structure, and the wave is in the shape of concave-convex volts. Under the viewing angle shown in FIG. 13 , the wave-like structure The top is a wave crest and the bottom is a wave trough. At the gap 401 , at least one wave crest at the wave-like structure of the second annular support frame 50 is suspended.

In this embodiment, the first annular support frame 30 is connected by three second wave-shaped support rods 33 along the axial direction of the first annular support frame 30 . In this embodiment, each of the second corrugated support rods 33 is made by laser engraving of nickel-titanium alloy, and the number of sine waves of the second corrugated support rods 33 is nine. In other embodiments, the number of the second wave supporting rods 33 and the number of the sine waves may be other numbers.

As shown in FIG. 8 , the connecting frame 40 is provided with a second inner cavity 47 that communicates with the first inner cavity 35 , and each adjacent two first connecting rods 45 and the first corrugated support rod 43 and the corresponding second corrugated support The rods 33 are surrounded by mesh holes 48 ; In this embodiment, the connecting skeleton 40 has a gradual change section 470. In the direction from the two sides of the gradual change section 470 to the middle of the gradual change section 470, the inner diameter of the second lumen 47 (ie the gradual change section 470) gradually increases, and the gradual change section 470 It can be understood as corresponding to the protruding portion 41 in the connecting frame 40 ;

As shown in FIG. 7 , the second annular support frame 50 includes a plurality of third wave support rods 53 with sinusoidal waveforms, and the plurality of third wave support rods 53 are sequentially arranged along the axial direction of the second annular support frame 50; each The third wave support rod 53 includes a plurality of third wave peaks 532, a plurality of third wave troughs 534, and a third wave rod 530 connecting two adjacent third wave peaks 532 and the third wave troughs 534. The wave troughs 434 and the third wave crests 532 are connected by the second connecting rods 46 ; that is, each first wave trough 434 of the first wave supporting rod 43 is adjacent to the third wave crest 53 of the third wave supporting rod 53 adjacent to the first wave supporting rod 43 . 532 is connected by the second connecting rod 46 . Each third corrugated support rod 53 is arranged in a circle along the circumferential direction of the second annular support skeleton 50 , a plurality of third corrugated support rods 53 constitute an annular grid structure, and every two adjacent third waved support rods 53 A plurality of mesh holes 57 are formed, and the diameter of each mesh hole 57 of the second annular supporting frame 50 is smaller than that of the mesh hole 48 .

In this embodiment, the second annular support frame 50 is connected by three third wave-shaped support rods 53 along the axial direction of the second annular support frame 50 . In this embodiment, each third wave support rod 53 is made by laser engraving of NiTi alloy, and the number of sine waves of the third wave support rod 53 is nine. In other embodiments, the third wave support rod 53 and the number of the sine waves may be other numbers.

The second annular support frame 50 has a third inner cavity 55 , that is, a plurality of third corrugated support rods 53 enclose a third inner cavity 55 extending in the axial direction, and each adjacent two third corrugated support rods 53 constitute a number of Grid holes 57. Each adjacent two second connecting rods 46 , the first corrugated supporting rod 43 and the corresponding third corrugated supporting rod 53 also enclose a grid hole 48 . The third inner cavity 55 communicates with the second inner cavity 47 , and the diameter of the mesh hole 48 is larger than the diameter of the mesh hole 57 of the second annular supporting frame 50 .

In this embodiment, the inner diameter of the end of the gradual change section 470 close to the first annular supporting frame 30 is equal to the inner diameter of the first lumen 35 , or the inner diameter of the end of the gradual change section 470 close to the second annular supporting frame 50 is equal to the inner diameter of the third lumen 55 . the inside diameter of. The middle portion of the first wave rod 430 is convex so that the first wave support rod 43 is enclosed to form at least part of the gradual change section 470 . In other embodiments, the inner diameter of the first lumen 35 is equal to the inner diameter of the third lumen 55 . At this time, the inner diameter values of the opposite sides of the gradual change section 470 are equal to the inner diameter value of the first inner cavity 35 and the inner diameter value of the second inner cavity 55 .

Optionally, in the direction from the two ends of the connecting frame 40 to the middle (that is, the reference plane α), the first connecting rods 45 are gradually inclined outward to be connected to the corresponding first wave crests 432 , and the second connecting rods 46 are gradually inclined toward the corresponding first wave crests 432 . The first connecting rod 45 , the first wave supporting rod 43 , and the second connecting rod 46 are enclosed to form a gradual change section 470 . If the first connecting rod 45 includes the first vertical section 452 and the first curved section 454, and the second connecting rod 46 includes the second vertical section 462 and the second curved section 464, then the first connecting rod 45 has a A portion (ie, the first curved section 454 ), a portion of the second wave rod 46 (ie, the second curved section 464 ), and the first wave support rod 43 are enclosed to form a gradual change section 470 .

As shown in FIG. 8 , the maximum outer diameter D1 of the protruding portion 41 is larger than the outer diameter D2 of the first annular support frame 30 and the outer diameter D3 of the second annular support frame 50 . In this embodiment, the outer diameter D2 of the first annular supporting frame 30 is equal to the outer diameter D3 of the second annular supporting frame 50; The outer diameter D2 of the annular support frame 30 protrudes by 1.5 mm to 2.5 mm. In other embodiments, the outer diameter D2 of the first annular support frame 30 and the outer diameter D3 of the second annular support frame 50 may not be equal. The axial length L1 of the connecting frame 40 may be the same as or different from the axial length L2 of the first annular support frame 30 and the axial length L3 of the second annular support frame 50; The axial length L1 , the axial length L2 of the first annular support frame 30 , and the axial length L3 of the second annular support frame 50 are equal, and are all 10 mm.

Optionally, the first annular supporting frame 30 , the connecting frame 40 , and the second annular supporting frame 50 may be a Nitinol laser-engraved one-piece bracket. In this embodiment, the width of the first wave rod 430 , the second wave rod 330 , the third wave rod 530 , the first connecting rod 45 and the second connecting rod 46 of the interventional venous valve stent 20 is 0.3 mm, and the rod thickness is 0.35 mm ; The total axial length of the interventional venous valve stent 20 is about 30 mm.

In other embodiments, the first annular support frame 30 , the connection frame 40 , and the second annular support frame 50 may be laser-engraved from different nickel-titanium alloys and then fixed and connected into one.

In a natural state, the axial direction of the first annular supporting frame 30 , the axial direction of the connecting frame 40 and the axial direction of the second annular supporting frame 50 are parallel to each other. Preferably, in a natural state, the axis of the first annular support frame 30 coincides with the axis of the second annular support frame 50 . It should be noted that the so-called natural state, that is, the intervening venous valve stent 20 is in a released state that is not subjected to external force in the radial direction.

In other embodiments, in a natural state, the axis of the first annular support frame 30 , the axis of the connection frame 40 and the axis of the second annular support frame 50 are coincident.

As shown in FIG. 7 , in the natural state, the two parts obtained by dividing the middle of the venous valve stent 20 by the reference plane α and the two parts obtained by dividing the lumen of the venous valve stent 20 by the reference plane α are both symmetrical with respect to the reference plane α , the normal direction of the reference plane α is parallel to the axial direction of the first annular support frame 30 or the second annular support frame 50, and the set of all points in the connection frame 40 used to form the maximum inner diameter of the connection frame 40 is located on the reference plane within α.

As shown in FIG. 8 , in the natural state, the two parts of the venous valve stent 20 divided by the reference plane β are symmetrical with respect to the reference plane β, the reference plane β and the first annular support frame 30 or the second annular support frame 50 The axes are parallel, and the reference plane β is located in the middle of the notch 401 .

As shown in FIG. 3 , the maximum opening angle C of the notch 401 in the circumferential direction of the connecting frame 40 ranges from 90° to 180°; the protruding portion 41 extends from one side of the connecting frame 40 to the The opposite side, that is, the opposite sides of the protruding portion 41, the first annular supporting frame 30 is close to the connecting frame 40 and is not connected to the first connecting rod 45, and the second annular supporting frame 50 is adjacent to the connecting frame 40. The part connecting the second connecting rod 46 forms a gap 401 .

In other embodiments, the support body and the connecting frame 40 are made of braided wires, that is, the first annular support frame 30 , the connecting frame 40 and the second annular support frame 50 are made of braided wires. Specifically, the interventional venous valve stent 20 is woven from a superelastic nickel-titanium wire, and the superelastic nickel-titanium alloy wire can be selected from a wire diameter (ie, diameter) ranging from 0.1 mm to 0.6 mm. The middle portion of the connecting frame 40 protrudes outward to form a protruding portion, and the inner side of the protruding portion forms a sinus area; specifically, the sinus area is obtained by a mold inserted into the connecting frame 40 after being shaped and heat-treated. The protruding part thus provided is a whole circle of annular shape, and the protruding part of the whole circle will reduce the anchoring force of both ends of the interventional venous valve stent 20, so a gap can be formed by cutting a part of the protruding part of the whole circle, In this way, the anchoring force at both ends of the interventional venous valve stent 20 is increased.

In other embodiments, the cross-sectional shapes of the first annular supporting frame 30 and the second annular supporting frame 50 are oval or shuttle-shaped. It should be noted that, in order to clearly define the cross section, the normal direction of the cross section is parallel to the axial direction of the first annular support frame 30 and the axial direction of the second annular support frame 50 .

Please refer to FIG. 3-FIG. 4 and FIG. 9-FIG. 10 together, the flap body 72 includes a first flap 721 attached to the inner surface of the first corrugated support rod 43 and attached to the inner surface of the plurality of first connecting rods 45 The second flap 723, and the third flaps 725 that fit the inner surfaces of the second connecting rods 46. The first flap 721, the second flap 723 and the third flap 725 can be an integrally formed structure, and the flap body 72 is connected to the inner side of the connecting frame 40 by suturing, bonding or hot pressing, so that the opposite ends of the flap body 72 are connected. The edges are respectively connected to the intersection of the first annular supporting frame 30 and the connecting frame 40 and the intersection of the second annular supporting frame 50 and the connecting frame 40 . Specifically, the edge of the second flap 723 away from the first flap 721 is connected to the intersection of the first annular support frame 30 and the connecting frame 40, and the edge of the third flap 725 away from the first flap 721 is connected to the second flap 721. The intersection of the annular support frame 50 and the connection frame 40 . The opposite sides of the valve body 72 extend to the opposite sides of the connecting frame 40 , that is, the opposite side edges of the valve body 72 cover the opposite sides of the notch 401 . The first corrugated support rod 43 fixed on the valve body 72 can increase the support strength, prevent the connecting frame 40 from being deformed due to the compression of the venous blood vessel, and prevent the valve leaflet 74 from losing the function of a one-way valve.

In other embodiments, the first flap 721 , the second flap 723 and the third flap 725 may be separate structures, and the first flap 721 , the second flap 723 and the third flap 725 are sutured, Adhesion or thermocompression is connected to the first corrugated support rod 43 , the first connecting rod 45 and the second connecting rod 46 , and the first flap 721 , the second flap 723 and the third flap 725 are integrated.

As shown in FIG. 4 and FIG. 10 , the valve leaflets 74 are connected to the inner side of the valve body 72 (ie, the side away from the connecting frame 40 ) by suture, bonding or thermocompression, so as to construct the flow of blood when passing through the venous valve prosthesis 100 . The one-way passage, ie, the leaflets 74, acts as a one-way valve. The leaflet 74 and the valve body 72 enclose a first area 75 and a second area 76, the first area 75 corresponds to a part of the sinus area 403, the second area 76 corresponds to another part of the sinus area 403, the first area 75 and the second area 76 are located on opposite sides of the valve leaflets 74 , and the valve leaflets 74 cover the first area 75 . One of the first region 75 and the second region 76 is in communication with the first inner cavity 35 of the first annular support frame 30 . In one embodiment, the first area 75 is the area that communicates with the first inner cavity 35 of the first annular support frame 30 after the valve leaflet 74 is arched, and the second area 76 is the area where the valve leaflet 74 is arched and communicated with the second annular supporting frame 30 . The area where the third inner cavity 55 of the support frame 50 communicates.

In other embodiments, the leaflet 74 and the valve body 72 can also be integrally formed.

In this embodiment, the valve assembly 70 further includes a membrane disposed on the peripheral wall of the support body, the membrane can be disposed on the inner surface or the outer surface of the support body, and each membrane is connected to the valve body 72 . Specifically, the coating includes a first coating 77 disposed on the peripheral wall of the first annular support frame 30 and a second coating 78 disposed on the second annular supporting frame 50 . The first coating 77 is sutured, Adhesion or heat pressing to the first annular support frame 30, and the side of the first covering film 77 close to the connecting frame 40 is connected to the valve body 72; the second covering film 78 is sutured, glued or heat pressed to the second ring The frame 50 is supported, and the side of the second covering film 78 close to the connection frame 40 is connected to the valve body 72 . Since the first annular support frame 30 is fixed on the first film 77 and the second annular support frame 50 is fixed on the second film 78, the first annular support frame 30 and the second annular support frame 50 use It is made of super-elastic nickel-titanium alloy. Therefore, when the interventional venous valve stent 20 is anchored to the inner wall of the venous blood vessel 300 , the first annular supporting frame 30 and the second annular supporting frame 50 elastically abut the venous blood vessel 300 respectively. In order to increase the supporting strength of the first annular support frame 30 and the second annular support frame 50, the anchor after the first annular support frame 30 and the second annular support frame 50 are implanted into the venous blood vessel is strengthened. Concentration.

In other embodiments, the first covering 77, the valve body 72 and the second covering 78 are integrally formed; or the leaflet 74, the first covering 77, the valve body 72 and the second covering 78 are integrally formed .

The valve leaflet 74, the first covering 77, the valve body 72 and the second covering 78 are all made of polyester, polytetrafluoroethylene, polyurethane, medical silicone, polyester, biological valve, pericardium or other implantable medical materials. production. .

As shown in FIG. 1 and FIG. 2 , the venous valve prosthesis 100 is implanted in the proper position of the lumen 301 of the venous blood vessel 300 through the delivery device, and the first annular support frame 30 and the second annular support frame 50 are anchored to the vein On the inner wall of the blood vessel 300, the connecting frame 40 abuts against the inner wall of the venous blood vessel 300 and protrudes outward. The second annular supporting frame 50 better anchors the venous blood vessel 300 , so that the venous valve prosthesis 100 is less likely to be displaced after the venous blood vessel 300 is implanted. Since the mesh holes 48 of the connecting frame 40 are larger than the mesh holes 37 of the first annular support frame 30 and the mesh holes 57 of the second annular support frame 50, and the connecting frame 40 is provided with a gap 401 in the circumferential direction, the venous valve is The prosthesis 100 has a certain flexibility as a whole, the venous valve prosthesis 100 is easily bent at the connection frame 40 , and the venous valve prosthesis 100 can more easily pass through complicated blood vessels, thereby reducing the risk of surgery. As shown in FIG. 7 , the mesh holes 48 of the connection frame 40 refer to the two first wave rods 430 adjacent to the first wave support rod 43 and the two first connections connected to the two first wave rods 430 The rod 45 and the space enclosed by the two second wave rods 330 connected to the ends of the two first connecting rods 45 away from the first wave supporting rod 43; the grid holes 37 of the first annular supporting frame 30 refer to Among the two adjacent second wave supporting rods 33 , the two second wave rods 330 adjacent to one second wave supporting rod 33 are in phase with the two second wave rods 330 corresponding to the other second wave supporting rod 33 . The closed space enclosed by the connection; the mesh holes 57 of the second annular support frame 50 refer to the adjacent two third wave support rods 53 , and two adjacent third wave support rods 53 of one third wave support rod 53 are adjacent to each other. A closed space is formed after the wave rod 530 is connected with two third wave rods 530 corresponding to another third wave support rod 53 . The opening area of the mesh hole 48 is larger than the opening area of the mesh hole 37 and the opening area of the mesh hole 57 . The blood in the lumen 301 of the venous blood vessel 300 flows downstream from the proximal end to the distal end, that is, from the third lumen 55 of the second annular support frame 50 to the first lumen 35 of the first annular support frame 30, The downstream blood impinges on the valve leaflet 74 and moves to the side away from the notch 401 , and the valve leaflet 74 is separated from the inner wall of the venous blood vessel 300 to open the one-way passage of the venous valve prosthesis 100 (as shown in FIG. 1 ). When the valve leaflet 74 is arched by the impact of the blood backflow in the venous blood vessel 300 (as shown in FIG. 2 ), the valve leaflet 74 is moved to the gap 401 by the impact of the blood backflow and abuts against the inner wall of the venous blood vessel 300 around the gap 401 , Thus, the valve leaflet 74 closes the lumen of the venous vessel 300 to avoid blood backflow; at the same time, a vortex area is formed in the first area 75 to effectively prevent local thrombosis. When the blood in the venous blood vessel 300 flows downstream again, the valve leaflet 74 is pushed by the downstream blood and moves to the side away from the gap 401 , referring to FIG. 4 , and the valve leaflet 74 squeezes out the blood in the first region 75 , so that the blood in the first region 75 flows to the first lumen 35; therefore, based on the existence of the second region 76, when the backflow disappears, the downstream one-way passage can be quickly opened to increase the downstream blood flow.

In other embodiments, the venous valve prosthesis 100 is provided with a visualization structure. Specifically, one of the first annular support frame 30 , the connection frame 40 and the second annular support frame 50 is provided with a visualization structure, or the first annular support frame 30 , the connecting frame 40 and the second annular support frame 50 Two of the annular supporting frame 30 , the connecting frame 40 and the second annular supporting frame 50 are provided with a developing structure, or the first annular supporting frame 30 , the connecting frame 40 and the second annular supporting frame 50 are respectively provided with a developing structure structure. The imaging structure is the imaging wire or imaging point wound on the venous valve prosthesis 100 continuously or intermittently, or the interventional venous valve stent 20 is made of an alloy doped with imaging materials, for example, the nickel-titanium alloy wire is made of Nitinol wire of tantalum.

Preferably, one of the first wave support rod 43 , the second wave support rod 33 adjacent to the connection frame 40 and the third wave support rod adjacent to the connection frame 40 encloses at least one circle of developing wires or development points. During the operation, the position of the annular developing structure can be clearly observed through the imaging device, and the venous valve prosthesis 100 can be inserted into the lumen 301 of the venous blood vessel 300 conveniently and quickly. The developer material includes, but is not limited to, gold, platinum, platinum-tungsten, palladium, platinum-iridium, rhodium, tantalum, or alloys or composites of these metals.

In other embodiments, the first covering film 77 and/or the second covering film 78 are provided with at least one circle of developing wires or developing dots, and the developing wires or developing dots are fixed on the on the first coating 77 and/or the second coating 78 .

Referring to FIG. 11, the structure of the venous valve prosthesis 100a provided by the second embodiment of the present application is similar to that of the first embodiment, the difference is that the venous valve prosthesis 100a is the venous valve prosthesis of the first embodiment On the basis of 100, the first coating 77 and the second coating 78 are omitted. Specifically, the valve assembly 70 only includes the valve body 72 disposed on the inner side of the connecting frame 40 and the valve leaflet 74 connected to the inner side of the valve body 72 . By omitting the first covering 77 and the second covering 78 in the venous valve prosthesis 100a, the manufacturing cost can be saved.

12 and FIG. 13 , the structure of the venous valve prosthesis provided by the third embodiment of the present application is similar to that of the first embodiment, the difference is: the connecting skeleton of the interventional venous valve stent 20a in the third embodiment The structure of 40a is different from the structure of the connection frame 40 of the interventional venous valve stent 20 in the first embodiment: specifically, the connection frame 40a includes a plurality of support rods 435, and the plurality of support rods 435 extend along the first annular support frame 30 or the second support frame 30. The support frame 50 extends in the axial direction and is arranged at intervals along the circumferential direction of the first annular support frame 30 or the second support frame 50. In the circumferential direction of the first annular support frame 30 or the second support frame 50, two adjacent The spaced regions between the support rods 435 form the notches 401 . Wherein, the gap 401 formed in the spaced area between the two adjacent support rods 435 with the largest distance can be used for the valve leaflet 74 to pass through to abut against the venous vessel wall, and the middle part of at least one support rod 435 is bent outward to form a protrusion Section 41.

In this embodiment, each support rod 435 includes a middle bending section 436 , a proximal vertical section 437 disposed at the proximal end of the middle bending section 436 , and a distal vertical section disposed at the distal end of the middle bending section 436 438 , one end of the proximal vertical section 437 away from the middle bent section 436 is connected to the first annular support frame 30 , and one end of the distal vertical section 438 away from the middle bent section 436 is connected to the second annular support frame 50 . The proximal vertical section 437 extends along the axial direction of the first annular support frame 30 , the distal vertical section 438 extends along the axial direction of the second annular support frame 50 , and the middle of the middle bending section 436 is bent outwards. A plurality of middle bent sections 436 form a protruding portion 41 , the inner side of the protruding portion 41 forms a sinus region 403 , and the valve assembly 70 is disposed in the sinus region 403 .

The proximal vertical sections 437 of the plurality of support rods 435 are respectively connected to the second troughs 334 of the adjacent second wave supporting rods 33 , and the distal vertical sections 438 are respectively connected to the third wave crests 532 of the adjacent third wave supporting rods 53 . A gap 401 is formed between the second trough 334 of the adjacent second wave support rod 33 and the third wave crest 532 of the third wave support rod 53 that is not connected by the support rod 435 .

In this embodiment, the number of the support rods 435 is six, which are arranged at intervals within a range of 270 degrees in the circumferential direction of the interventional venous valve stent 20a. In the area where the support rods 435 are arranged, the circumferential interval angle between two adjacent support rods 435 is 45 degrees. At this time, the 90-degree interval in which the support rods 435 are not arranged in the interventional venous valve stent 20a forms an available valve The notch 401 through which the leaf 74 passes, that is, the opening circumferential angle of the notch 401 is 90 degrees.

Please refer to FIG. 14 and FIG. 15 , the structure of the venous valve prosthesis 100 b provided by the fourth embodiment of the present application is similar to the structure of the venous valve prosthesis 100 of the first embodiment, the difference is that the venous valve prosthesis in the fourth embodiment The prosthesis 100b is based on the venous valve prosthesis 100 of the first embodiment and omits the second annular support frame 50 and the second membrane 78, that is, the interventional venous valve stent only includes the first annular support frame 30 and the connection. The connecting frame 40 at the end of the first annular support frame 30; the valve assembly 70 only includes the valve body 72, the valve leaflets 74 and the first covering 77, and the valve body 72 is sutured, bonded or hot-pressed to the connecting frame 40, and the valve The leaflet 74 is sutured, bonded or hot-pressed to the valve body 72 , the first covering 77 is sutured, bonded or thermo-compressed to the first annular support frame 30 , and the valve body 72 is connected to the first covering 77 . The venous valve prosthesis 100b omits the second annular support frame 50 and the second membrane 78 to save the manufacturing cost. It should be understood that, in this embodiment, the first covering film 77 may also be omitted.

It should be noted that, without departing from the principles of the present application, the specific technical solutions in each embodiment may be mutually applicable.

The above is the implementation of the embodiments of the present application. It should be pointed out that for those of ordinary skill in the art, without departing from the principles of the embodiments of the present application, several improvements and modifications can also be made. These improvements and modifications are also It is regarded as the protection scope of this application.

Claims (20)

An interventional venous valve stent capable of radial compression and expansion, characterized in that it comprises: a support body, including a first annular support frame; and a connecting frame, the connecting frame is connected to the end of the first annular supporting frame, the connecting frame is arranged along the circumferential direction of the first annular supporting frame and is formed by being disconnected in the circumferential direction of the connecting frame At least part of the connecting frame protrudes outward to form a protruding part, and the inner side of the protruding part forms a sinus area. The interventional venous valve stent according to claim 1, wherein the side of the first annular support frame facing or connecting to the connecting frame is in a wavy structure, and at the gap, at least one part of the wavy structure is in a wavy structure. A valley floating setting. The interventional venous valve stent according to claim 1, wherein the connecting frame comprises a first wave-shaped support rod, and the first wave-shaped support rod extends along the circumferential direction of the first annular support frame, and the The first wave supporting rod includes a plurality of first wave rods connected end to end, and at least part of the first wave rods are bent outward to form at least a part of the protruding portion. The interventional venous valve stent according to claim 3, wherein the first wave support rod has a first wave crest close to the first annular support frame and a first wave crest away from the first annular support frame a wave trough; the connecting frame includes at least one first connecting rod, and the first connecting rod connects the first wave crest and the first annular supporting frame. The interventional venous valve stent according to claim 3, wherein the connecting frame further comprises at least one second connecting rod, and the second connecting rod is connected to the first trough. The stent for interventional venous valve according to claim 5, characterized in that, in a direction from an end of the second connecting rod away from the first wave-shaped support rod to an end close to the first wave-shaped support rod, the The second connecting rod is inclined or bent outward to connect with the corresponding first trough, and the second connecting rod is formed as a part of the protrusion. The stent for interventional venous valve according to claim 4, wherein the middle part of each first wave rod is outwardly convex to form a part of the protruding part; when the first connecting rod is close to the first wave rod From one end of an annular support frame to the direction away from one end of the first annular support frame, each of the first connecting rods is inclined or bent outward to connect with the corresponding first wave crest. The first connecting rod is formed as part of the protrusion. The interventional venous valve stent according to claim 4, wherein the middle portion of each of the first wave rods is outwardly convex to form a part of the protruding portion; the first connecting rod comprises a first vertical section and a first curved section, the first vertical section extends along the axial direction of the first annular support frame, from an end of the first connecting rod close to the first annular support frame to a distance away from the first annular support frame In the direction of one end of the first annular support frame, the first curved section is gradually bent outward to connect with the corresponding first wave crest, and the first curved section forms a part of the protruding portion. The interventional venous valve stent according to claim 4, wherein the first annular support frame comprises a plurality of second wave-shaped support rods, and the plurality of second wave-shaped support rods are supported along the first annular shape The skeletons are arranged in order in the axial direction; each of the second wave support rods includes a plurality of second wave crests, a plurality of second wave troughs, and a second wave connecting two adjacent second wave crests and the second wave troughs. Two wave rods, two ends of the first connecting rod are respectively connected to the first wave crest and the second wave trough. The interventional venous valve stent according to claim 9, wherein each adjacent two first connecting rods, the first corrugated supporting rod and the corresponding second corrugated supporting rod enclose a first For grid holes, each adjacent two second wave supporting rods form a plurality of second grid holes, and the aperture value of the first grid holes is larger than the aperture value of the second grid holes. The stent for interventional venous valve according to claim 1 or 2, wherein the connecting frame includes a plurality of support rods, and a plurality of the support rods extend along the axial direction of the first annular support frame and along the first annular support frame. A ring-shaped support frame is arranged at intervals in the circumferential direction, and in the circumferential direction of the first ring-shaped support frame, the gap is formed between any two adjacent support rods, and at least one of the support rods faces the gap. The outer bend forms the protrusion. The interventional venous valve stent according to any one of claims 1 to 11, wherein the supporting body further comprises a second annular supporting frame, and the connecting frame is disposed between the first annular supporting frame and the supporting frame. Between the second annular supporting frames, the connecting frames are arranged along the circumferential direction of the second annular supporting frames. The stent for interventional venous valve according to claim 12, wherein the outer diameter of the protruding portion is larger than the outer diameter of the first annular support frame and the outer diameter of the second annular support frame. The interventional venous valve stent according to claim 12, wherein, in a natural state, the axial direction of the first annular support frame is parallel to the axial direction of the second annular support frame. The interventional venous valve stent according to claim 12, characterized in that, in a natural state, two parts of the lumen of the venous valve stent divided by a reference plane are symmetrical with respect to the reference plane, and the normal of the reference plane is symmetrical with respect to the reference plane. The direction is parallel to the axial direction of the first annular support frame, and the set of all points forming the largest inner diameter of the connecting frame is located in the reference plane. The stent for interventional venous valve according to claim 1, wherein the maximum opening angle of the gap in the circumferential direction of the connecting frame is between 90 degrees and 180 degrees. The stent for interventional venous valve according to claim 1, wherein the protruding portion extends from one side of the connecting frame to the other opposite side along the circumferential direction of the connecting frame. A venous valve prosthesis for implanting a venous blood vessel, wherein the venous valve prosthesis comprises the interventional venous valve stent and valve assembly according to any one of claims 1-16, the valve assembly including The valve leaflet is connected to the inner side of the connecting frame, the valve leaflet covers at least part of the sinus region and is used to construct a one-way passage in the venous blood vessel. The venous valve prosthesis according to claim 18, wherein the valve assembly further comprises a valve body attached to the inner surface of the connecting frame, and the valve leaflet and the valve body enclose a first area and a second area, the first area corresponds to a part of the sinus area, the second area corresponds to another part of the sinus area, the first area and the second area are located on two opposite sides of the valve leaflet On the side, one of the first region and the second region communicates with the inner cavity of the first annular support frame, and the leaflet cover is provided in the first region. The venous valve prosthesis according to claim 19, wherein the valve assembly further comprises a membrane disposed on the peripheral wall of the support body, and the membrane is connected to the valve body.

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