CN114145884A - Interventional venous valve support and venous valve prosthesis - Google Patents

Abstract

The invention provides an interventional venous valve support, which comprises a support body and a connecting framework, wherein the support body comprises a first annular supporting framework, the connecting framework is connected to the end part of the first annular supporting framework, the connecting framework is arranged along the circumferential direction of the first annular supporting framework and is disconnected in the circumferential direction of the connecting framework to form a gap, at least part of the connecting framework protrudes outwards to form a convex part, and a sinus region is formed on the inner side of the convex part. The gap can ensure that the interventional venous valve support has better flexibility, so that the interventional venous valve support can more easily pass through circuitous and complex blood vessels, and the operation risk is reduced; the valve leaf makes the backflow blood form the vortex in the area that the valve leaf covers in the sinus region, prevents that blood from withdrawing to make venous valve prosthesis's clinical effect better. The invention also provides a venous valve prosthesis provided with the interventional venous valve stent.

Description

Interventional venous valve support and venous valve prosthesis

Technical Field

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

Background

The venous surgical diseases are common surgical diseases, mostly occur in lower limbs, and are mainly clinically manifested as varicose veins, limb swelling, skin dystrophy diseases in foot and boot areas, such as dermatitis, pigmentation, ulceration and the like. The main pathological reason is that the venous valve loses the basic function of unidirectional opening under the action of pathogenic factors. The mild patients with venous diseases obstruct life and working ability, and the severe patients can cause diseases and disabilities with different degrees. Therefore, the treatment of venous valvular disease of the lower extremities is increasingly gaining importance. At present, most of the diseases are clinically treated by conservative treatment, such as drug treatment, pressure pump and the like, and surgical treatment, such as femoral vein valve repair and reconstruction surgery and the like, has unsatisfactory clinical effect. Particularly, in patients with severe damage of venous valves or congenital valveless disease, the transplantation of the venous valves seems to be the only method to be selected, and currently, the venous valve prosthesis with valves is clinically adopted, however, the clinical effect of the venous valve prosthesis is not ideal due to poor anchoring force, insufficient flexibility, local thrombosis and the like after the venous valve prosthesis in the related art is implanted into blood vessels.

Disclosure of Invention

The invention aims to provide a venous valve prosthesis and an interventional venous valve stent with better clinical effect.

In order to solve the technical problem, the invention provides an interventional venous valve stent capable of being compressed and expanded in a radial direction, which comprises a support body and a connecting framework, wherein the support body comprises a first annular supporting framework, the connecting framework is connected to the end part of the first annular supporting framework, the connecting framework is arranged along the circumferential direction of the first annular supporting framework and is broken in the circumferential direction of the connecting framework to form a gap, at least part of the connecting framework protrudes outwards to form a convex part, and the inner side of the convex part forms a sinus region.

The invention also provides a venous valve prosthesis for implantation in a venous vessel, the venous valve prosthesis comprising an interventional venous valve stent and a valve assembly comprising leaflets attached to the inside of the connecting skeleton, the leaflets covering at least part of the sinus region and serving to establish a one-way access in the venous vessel.

The notch on the connecting framework of the venous valve prosthesis reduces the excessive expansion of the convex part of the connecting framework on the vein vessel wall, and the notch can ensure that the interventional venous valve stent has better flexibility, so that the interventional venous valve stent can more easily pass through circuitous and complex blood vessels, and the operation risk is reduced; in addition, the valve leaflets are in a suspended state under the action of the vortex and are not attached to the vein wall, so that the risk of adhesion can be reduced, and the formed vortex can avoid the risk of thrombus formation caused by the stagnation of blood flow at the root parts of the valve leaflets; the valve leaflets move towards the gaps under the impact of the backflow of the blood in the venous blood vessel and are abutted against the inner wall of the venous blood vessel around the gaps, so that the backflow blood forms vortex in the area of the sinus area covered by the valve leaflets, the blood is prevented from returning, and the risk of thrombus formation caused by the stagnation of the blood flow at the root parts of the valve leaflets is avoided; thereby leading the clinical effect of the vein valve prosthesis to be better.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

Fig. 1 is a schematic view of a vein valve prosthesis according to a first embodiment of the present invention in a use state;

FIG. 2 is a schematic view of an anti-reflux state of a venous valve prosthesis provided in accordance with a first embodiment of the present invention;

fig. 3 is a schematic perspective view of a venous valve prosthesis according to a first embodiment of the present invention;

FIG. 4 is a front view of the venous valve prosthesis of FIG. 3;

fig. 5 is a schematic view of a vein valve prosthesis according to a first embodiment of the present invention in a use state;

fig. 6 is a schematic view of a vein valve prosthesis according to the first embodiment of the present invention in a further use state;

FIG. 7 is a left side view of an interventional venous valve stent of the venous valve prosthesis of FIG. 3;

FIG. 8 is a front view of the interventional venous valve stent of FIG. 3;

FIG. 9 is a perspective exploded view of the valve assembly of FIG. 3;

FIG. 10 is a perspective assembled schematic view of the valve assembly of FIG. 9;

fig. 11 is a schematic perspective view of a venous valve prosthesis according to a second embodiment of the present invention;

fig. 12 is a front view of an interventional venous valve stent provided in a third embodiment of the present invention;

fig. 13 is a left side view of the interventional venous valve stent of fig. 12;

fig. 14 is a perspective view of an interventional venous valve stent provided in a fourth embodiment of the present invention;

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 invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.

Furthermore, the following description of the various embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. Directional phrases used in this disclosure, such as, for example, "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the orientation of the appended drawings and are, therefore, used herein for better and clearer illustration and understanding of the invention, and do not indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, and are therefore not to be considered limiting of the invention.

In the description of the present invention, the term "proximal" as used herein refers to the end near the heart site and the term "distal" refers to the end away from the heart site, and this definition is for convenience of presentation and should not be construed as limiting the invention.

Referring to fig. 1 and 2 together, the present invention provides a venous valve prosthesis 100 for implantation in a venous vessel 300 for establishing a one-way pathway within the venous vessel 300 to prevent blood backflow. Fig. 1 illustrates a schematic view of a state of use of the venous valve prosthesis 100 in which a blood flow path of the venous valve prosthesis 100 is opened under proximal-to-distal forward blood flow impingement, and fig. 2 illustrates a schematic view of an anti-reflux state of the venous valve prosthesis 100 in which the blood flow path of the venous valve prosthesis 100 is closed under distal-to-proximal reverse blood flow impingement.

Referring to fig. 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 being of a mesh-tube structure and being radially compressible and expandable. The interventional venous valve support 20 comprises a support body and a connecting framework 40, wherein the support body comprises a first annular supporting framework 30 and a second annular supporting framework 50, and the connecting framework 40 is positioned between the first annular supporting framework 30 and the second annular supporting framework 50; specifically, the first annular support frame 30 is connected to the proximal end of the connecting frame 40, and the second annular support frame 50 is connected to the distal end of the connecting frame 40, that is, the connecting frame 40 is connected between the distal end of the first annular support frame 30 and the proximal end of the second annular support frame 50. The connecting framework 40 is arranged along the circumferential direction of the first annular supporting framework 30 and the second annular supporting framework 50, the connecting framework 40 is broken in the circumferential direction to form a gap 401, at least part of the connecting framework 40 protrudes outwards to form a convex part 41, and the inner side of the convex part 41 forms a sinus region 403. The "sinus region" is a region where a depression is formed in the inner surface of the connecting skeleton 40, and may be a region where the inner diameter of a lumen surrounded by the connecting skeleton 40 is locally increased.

Valve assembly 70 includes a valve body 72 attached to the inside of connecting frame 40 and a valve leaflet 74 attached to the inside of valve body 72, valve leaflet 74 covering at least a portion of 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 sewn, adhered or hot pressed to the connecting frame 40, and one edge of the valve leaflet 74 is sewn, adhered or hot 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 vortex accommodation space with a V-shaped cross section, where the cross section is parallel to the axial direction of the interventional venous valve support 20.

After the venous valve prosthesis 100 is implanted into the venous vessel 300, the interventional venous valve stent 20 is attached to the intima of the venous vessel 300, so that the interventional venous valve stent 20 is stably anchored to the venous vessel 300, and blood in the venous vessel 300 is prevented from leaking out from between the interventional venous valve stent 20 and the intima of the venous vessel 300, namely, the blood flows in the inner cavity of the interventional venous valve stent 20. Referring to fig. 2, when the blood in the venous vessel 300 flows from the distal end to the proximal end, the valve leaflet 74 moves towards the notch 401 under the impact of the blood flow until the valve leaflet 74 abuts against the inner wall of the venous vessel 300 around the notch 401, and the valve leaflet 74 closes the venous vessel 300, thereby effectively avoiding the blood backflow; referring to fig. 1, as blood in the venous vessel 300 flows from the proximal end to the distal end, the blood flow impinges on the leaflets 74 moving toward the side away from the notch 401 to open a one-way path to the venous vessel 300.

For further explanation, referring to fig. 3 and 4, the leaflet 74 includes a fixed edge 742 and a free edge 745, the fixed edge 742 being fixedly attached to the body 72, and the free edge 745 being free to float. Under the impact of the backflow of blood within the venous blood vessel 300 (see fig. 2), the free edge 745 can move toward the notch 401 and abut the venous blood vessel wall around the notch 401 to form a one-way passageway within the venous blood vessel 300. Under the impact of downstream blood flow within venous vessel 300 (fig. 1), free edge 745 moves toward sinus region 403 and free edge 745 separates from the venous vessel wall to open a one-way passageway within venous vessel 300.

It should be noted that, under the backward flow impact of the blood in the venous vessel 300, the leaflet 74 forms an arch structure for blocking the backward flow, and referring to fig. 5, a tiny gap 404 may exist between the free edge 745 and the wall of the venous vessel, and at this time, the free edge 745 does not abut against the wall of the venous vessel, so that the risk of adhesion of the free edge 745 to the tissue of the vessel wall is reduced, and the tiny gap 404 between the free edge 745 and the wall of the venous vessel does not affect the leaflet 74 to block most of the backward flow blood. In addition, the free edge 745 may be located near the area of the gap 401 under the impact of the backflow of blood in the venous blood vessel 300. referring to fig. 6, the free edge 745 may also be located in the lumen defined by the first annular support frame 30. In other embodiments, the free edge 745 may be located in the inner cavity defined by the second annular supporting framework 50, and the invention is not limited thereto.

The venous valve prosthesis 100 provided by the invention has the advantages that the sinus region 403 is formed on the inner side of the convex part 41 connected with the framework 40, and the gap 401 is formed by the circumferential disconnection of the connection framework 40; the notches 401 reduce the metal coverage of the protrusions 41 and reduce the excessive dilation of the vein wall by the protrusions 41 of the connection skeleton 40, which in turn reduces the excessive irritation of the intima of the vein. And the gap 401 enables the interventional venous valve support 20 to have better flexibility, so that the interventional venous valve support 20 can more easily pass through tortuous complex blood vessels, and the operation risk is reduced.

Secondly, in the process that the downstream blood in the venous vessel 300 flows along the unidirectional pathway (fig. 1), 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, and at the moment, the free edge 745 of the valve leaflet 74 is in a suspension state under the action of the vortex and is not attached to the vein wall, so that the risk of adhesion can be reduced, and the formed vortex can also avoid the risk of thrombus formation caused by the stagnation of the blood flow at the root of the valve leaflet 74; the valve leaflet 74 moves towards the notch 401 under the impact of the backflow of blood in the venous blood vessel 300 and abuts against the inner wall of the venous blood vessel 300 around the notch 401 (fig. 2), so that the backflow of blood forms a vortex in the area of the sinus region 403 covered by the valve leaflet 74, the blood is prevented from backing back, and the risk of thrombus formation due to the stagnation of blood flow at the root of the valve leaflet 74 is avoided.

In addition, the interventional venous valve stent 20 is a nickel-titanium alloy mesh cylindrical stent, the interventional venous valve stent 20 has high rigidity, after the interventional venous valve stent 20 is implanted into the venous vessel 300, the interventional venous valve stent 20 always keeps a fixed shape, the valve body 72 is not influenced by the pressure change of the venous vessel 300, and the function of the valve leaf 74 is not influenced, and the first annular support framework 30 and the second annular support framework 50 have high radial support force, so that the interventional venous valve stent 20 can be better anchored to the venous vessel 300, the stimulation to the intima of the venous vessel 300 is relieved, and the intimal hyperplasia is prevented.

In one embodiment, connecting framework 40 is a non-closed mesh stent that is continuously disposed in its circumferential direction, so-called "continuous", i.e., connecting framework 40 extends continuously over an angle in its circumferential direction without breaking. Specifically, as shown in fig. 7 and 8, the connecting skeleton 40 includes a first wave-shaped supporting rod 43 having a sine wave shape, the first wave-shaped supporting rod 43 includes a plurality of first wave-shaped rods 430 connected end to end, and at least a part of the middle portion of at least a part of the first wave-shaped rods 430 protrudes outward to form at least a part of the protruding portion 41. That is, the first wave bar 430 whose middle portion is convex may form a part of the convex portion 41, or may form the whole of the convex portion 41. In this embodiment, the number of the first wave supporting rods 43 is one, the first wave supporting rods 43 are arranged along the circumferential direction of the first annular supporting skeleton 30, and the first wave supporting rods 43 are broken in the circumferential direction to form the parts of the notches 401, and the middle part of each first wave supporting rod 430 protrudes outwards.

The first wave supporting rod 43 has a first wave peak 432 close to the first annular supporting skeleton 30 and a first wave trough 434 far away from the first annular supporting skeleton 30, and the first wave peak 432 and the first wave trough 434 are both formed between two adjacent first wave rods 430. The connecting framework 40 further comprises a plurality of first connecting rods 45 extending in the axial direction of the connecting framework 40, the first connecting rods 45 being arranged between the first wave crests 432 and the first annular supporting framework 30. In this embodiment, each first peak 432 of the first wave-shaped 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-shaped supporting rod 43 is connected to the first annular supporting framework 30.

Preferably, each first connecting rod 45 is gradually inclined outward to connect to the corresponding first peak 432 in a direction from the end of the first connecting rod 45 close to the first annular support skeleton 30 to the end far from the first annular support skeleton 30, the first connecting rod 45 is formed as a part of the protrusion 41, that is, the first connecting rod 45 is formed as a proximal portion of the protrusion 41. In this embodiment, the first connecting rod 45 includes a first vertical section 452 and a first bending section 454, the first vertical section 452 extends along the axial direction of the first annular supporting framework 30, the first bending section 454 is gradually bent outward from the first vertical section 452 to the first wave-shaped supporting rod 43 of the connecting framework 40 to connect to the corresponding first wave peak 432, the first bending section 454 forms a part of the protruding portion 41, that is, the first bending section 454 forms a proximal portion of the protruding portion 41, and the inner cavity formed by the first vertical section 452 is of an isometric variation, and 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 framework 40 further includes a plurality of second connecting rods 46 extending along the axial direction of the connecting framework 40, one end of each second connecting rod 46 is connected to the first wave trough 434 far away from the first annular supporting framework 30 in the connecting framework 40, and the other end, opposite to the second connecting rod 46, is connected to the distal end of the second annular supporting framework 50. Specifically, each first wave trough 434 of the first wave shaped supporting rod 43 is connected with one second connecting rod 46, and the end of the second connecting rod 46 far away from the first wave shaped supporting rod 43 is connected with the second annular supporting framework 50.

Preferably, each second connecting rod 46 is gradually inclined outward to be connected to the corresponding first wave trough 434 in a direction from the end of the second connecting rod 46 close to the second annular support skeleton 50 to the end far from the second annular support skeleton 50, and the second connecting rod 46 is formed as a part of the protrusion 41, i.e., the second connecting rod 46 is formed as the distal end portion of the protrusion 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 supporting skeleton 50, the second curved section 464 is gradually curved outwards from the second vertical section 462 to the first wave-shaped supporting rod 43 of the connecting skeleton 40 to connect to the corresponding first wave trough 434, the second curved section 464 forms a part of the protrusion 41, that is, the second curved section 464 forms a distal portion of the protrusion 41, and the inner cavity formed by the second vertical section 462 is changed in an equal diameter manner, and the first vertical section 462 does not have a convex structure and does not belong to the protrusion 41.

In other embodiments, the connecting skeleton 40 may not include the first connecting rod 45 and the second connecting rod 46, and the first wave crests 432 of the first wave supporting rod 43 may be directly connected to the first annular supporting skeleton 30, and the first wave troughs 434 of the first wave supporting rod 43 may be directly connected to the second annular supporting skeleton 50.

In other embodiments, the number of the first waveform supporting rods 43 is plural, and the plural first waveform supporting rods 43 are arranged along the axial direction of the connecting skeleton 40. The first wave crests 432 of each adjacent two first waveform supporting rods 43 are connected with the corresponding first wave troughs 434. In other embodiments, the first annular supporting framework 30 and the second annular supporting framework 50 have a grid structure, and the inner diameter of the grid formed by the adjacent two first corrugated supporting rods 43 is larger than the inner diameter of the grid formed by the first annular supporting framework 30 and the inner diameter of the grid formed by the second annular supporting framework 50.

As shown in fig. 7 and 8, the first annular supporting skeleton 30 includes a plurality of second waveform supporting rods 33 having a sine waveform, and the plurality of second waveform supporting rods 33 are sequentially arranged along the axial direction of the first annular supporting skeleton 30; each second waveform supporting rod 33 comprises a plurality of second peaks 332, a plurality of second troughs 334, and a second wave rod 330 connecting two adjacent second peaks 332 and second troughs 334, wherein adjacent first peaks 432 and second troughs 334 are connected by a first connecting rod 45; that is, each first peak 432 of the first wave strut 43 is connected to the second valley 334 adjacent to the second wave strut 33 of the first wave strut 43 by the first connecting rod 45. Each second waveform supporting rod 33 is provided with a circle along the circumferential direction of the first annular supporting framework 30, a plurality of second waveform supporting rods 33 enclose a first inner cavity 35 extending along the axial direction, the plurality of second waveform supporting rods 33 form an annular grid structure, and every two adjacent second waveform supporting rods 33 form a plurality of grid holes 37.

In the present embodiment, the first annular support frame 30 is connected by three second corrugated support rods 33 along the axial direction of the first annular support frame 30. In this embodiment, each of the second waveform supporting rods 33 is formed by laser engraving nitinol, and the number of the sine waves of the second waveform supporting rods 33 is 9. In other embodiments, the number of the second waveform supporting rods 33 and the number of the sine waves may be other numbers.

As shown in fig. 8, the connecting framework 40 is provided with second inner cavities 47 communicated with the first inner cavities 35, and every two adjacent first connecting rods 45, the first corrugated supporting rods 43 and the corresponding second corrugated supporting rods 33 define grid holes 48; the mesh openings 48 have a larger diameter than the mesh openings 37 of the first annular support skeleton 30. In the present embodiment, the connecting skeleton 40 has a transition section 470, and the inner diameter of the second inner cavity 47 (i.e. the transition section 470) is gradually increased in the direction from the two sides of the transition section 470 to the middle of the transition section 470, and the transition section 470 can be understood as corresponding to the protrusion 41 in the connecting skeleton 40; the gap 401 is disposed in the transition section 470 of the connecting frame 40, and the gap 401 is communicated with the second cavity 47.

As shown in fig. 7, the second annular support skeleton 50 includes a plurality of third waveform support rods 53 having a sinusoidal waveform, the plurality of third waveform support rods 53 being sequentially arranged along the axial direction of the second annular support skeleton 50; each third waveform supporting rod 53 comprises a plurality of third peaks 532, a plurality of third valleys 534, and a third waveform 530 connecting two adjacent third peaks 532 and third valleys 534, wherein the adjacent first valleys 434 and third peaks 532 are connected by a second connecting rod 46; that is, each first wave trough 434 of the first wave supporting rod 43 is connected to the third wave crest 532 adjacent to the third wave supporting rod 53 of the first wave supporting rod 43 by the second connecting rod 46. Each third waveform support rod 53 is arranged in a circle along the circumferential direction of the second annular support framework 50, the plurality of third waveform support rods 53 form an annular grid structure, each two adjacent third waveform support rods 53 form a plurality of grid holes 57, and the aperture of each grid hole 57 of the second annular support framework 50 is smaller than that of the grid hole 48.

In the present embodiment, the second annular support frame 50 is connected by three third waveform support rods 53 along the axial direction of the second annular support frame 50. In this embodiment, each of the third waveform supporting rods 53 is made of nitinol through laser engraving, and the number of the sine waves of the third waveform supporting rods 53 is 9. In other embodiments, the number of the third waveform support rods 53 and the number of the sine waves may be other numbers.

The second annular supporting skeleton 50 has a third inner cavity 55, that is, a plurality of third waveform supporting rods 53 enclose the third inner cavity 55 extending along the axial direction, and every two adjacent third waveform supporting rods 53 form a plurality of grid holes 57. Every two adjacent second connecting rods 46, the first corrugated supporting rods 43 and the corresponding third corrugated supporting rods 53 also enclose the grid holes 48. The third lumen 55 is in communication with the second lumen 47 and the mesh openings 48 have a larger diameter than the mesh openings 57 of the second annular support structure 50.

In this embodiment, the inner diameter of the transition section 470 near the end of the first annular support structure 30 is equal to the inner diameter of the first lumen 35, or the inner diameter of the transition section 470 near the end of the second annular support structure 50 is equal to the inner diameter of the third lumen 55. The middle of the first wave bar 430 is convex outward such that the first wave bar 43 encloses at least a portion of the transition 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 of the transition section 470 is equal to the inner diameter of the first inner cavity 35 and the inner diameter of the second inner cavity 55.

Alternatively, in a direction from both ends to the middle (i.e., the reference plane α) of the connecting skeleton 40, the first connecting rods 45 are gradually inclined outward to connect to the corresponding first wave crests 432, and the second connecting rods 46 are gradually inclined outward to connect to the corresponding first wave troughs 434; the first connecting rod 45, the first wave-shaped supporting rod 43 and the second connecting rod 46 enclose to form a gradual transition section 470. If the first connecting rod 45 includes the first vertical section 452 and the first bending section 454, and the second connecting rod 46 includes the second vertical section 462 and the second bending section 464, then the portion of the first connecting rod 45 (i.e., the first bending section 454), the portion of the second wave bar 46 (i.e., the second bending section 464), and the first wave-shaped supporting rod 43 enclose to form the transition section 470.

As shown in fig. 8, the maximum outer diameter D1 of the protrusion 41 is greater than the outer diameters D2 of the first and second annular support armatures 30 and 50, D3. In this embodiment, the outer diameter D2 of the first annular support skeleton 30 is equal to the outer diameter D3 of the second annular support skeleton 50; the outer diameter D2 ranges from 5 mm to 30 mm, with the maximum outer diameter D1 protruding 1.5 mm to 2.5 mm beyond the outer diameter D2 of the first annular support scaffold 30. In other embodiments, the outer diameter D2 of the first annular support skeleton 30 may not be equal to the outer diameter D3 of the second annular support skeleton 50. 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; in the present embodiment, the axial length L1 of the connecting frame 40, the axial length L2 of the first annular supporting frame 30, and the axial length L3 of the second annular supporting frame 50 are equal and 10 mm.

Alternatively, the first annular support frame 30, the connecting frame 40, and the second annular support frame 50 may be a nitinol laser-engraved type integrated stent. In this embodiment, the widths of the first wave bar 430, the second wave bar 330, the third wave bar 530, the first connecting bar 45 and the second connecting bar 46 of the interventional venous valve stent 20 are 0.3 mm, and the bar thicknesses are 0.35 mm; the total axial length of the interventional venous valve stent 20 is about 30 millimeters.

In other embodiments, the first annular supporting frame 30, the connecting frame 40, and the second annular supporting frame 50 may be respectively fixed and connected to one body by laser engraving of different nitinol.

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 two by two. 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 is a released state in which the interventional venous valve stent 20 is not subjected to an external force in the radial direction.

In other embodiments, in a natural state, the axis of the first annular supporting frame 30, the axis of the connecting frame 40, and the axis of the second annular supporting frame 50 coincide with each other.

As shown in fig. 7, in a natural state, both of two portions of the middle of the venous valve holder 20 divided by the reference plane α and two portions of the lumen of the venous valve holder 20 divided by the reference plane α are symmetrical with respect to the reference plane α, a normal direction of the reference plane α is parallel to an axial direction of the first or second annular support skeletons 30 or 50, and a set of all points of the connecting skeletons 40 for forming a maximum inner diameter of the connecting skeletons 40 is located within the reference plane α.

As shown in fig. 8, in a natural state, two portions of the venous valve support 20 divided by the reference plane β are symmetrical with respect to the reference plane β, the reference plane β is parallel to an axial direction of the first annular support frame 30 or the second annular support frame 50, and the reference plane β is located in the middle of the gap 401.

As shown in fig. 3, the maximum opening angle C of the notch 401 in the circumferential direction of the connecting skeleton 40 ranges from 90 degrees to 180 degrees; the protrusion 41 extends from one side of the connecting frame 40 to the other opposite side along the circumferential direction of the connecting frame 40, that is, the two opposite sides of the protrusion 41, the portion of the first annular supporting frame 30 near the connecting frame 40 where the first connecting rod 45 is not connected, and the portion of the second annular supporting frame 50 near the connecting frame 40 where the second connecting rod 46 is not connected enclose the notch 401.

In other embodiments, the support body and the connecting framework 40 are made of braided wires, i.e., the first annular support framework 30, the connecting framework 40 and the second annular support framework 50 are made of braided wires. Specifically, the interventional venous valve stent 20 is woven by a superelastic nickel titanium wire, and the wire diameter (i.e., diameter) of the superelastic nickel titanium alloy wire can be selected within the range of 0.1mm to 0.6 mm. The middle part of the connecting framework 40 is provided with a convex part in an outward protruding way, and the inner side of the convex part forms a sinus region; specifically, the sinus region is obtained by heat treatment after molding by a mold inserted into the connection skeleton 40. The bulge portion is a complete ring of the annular shape, and the bulge portion of the complete ring can reduce the anchoring force at the two ends of the interventional venous valve support 20, so that a notch can be formed by cutting a part of the bulge portion of the complete ring, and the anchoring force at the two ends of the interventional venous valve support 20 is improved.

In other embodiments, the cross-sectional shape of the first and second annular support armatures 30 and 50 is oval, fusiform, or the like. It should be noted that, for clarity of definition of 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.

Referring to fig. 3-4 and 9-10, the flap 72 includes a first flap 721 attached to the inner surface of the first corrugated supporting rod 43, a second flap 723 attached to the inner surfaces of the first connecting rods 45, and a third flap 725 attached to the inner surfaces of the second connecting rods 46. The first, second and third flaps 721, 723 and 725 may be integrally formed structures, and the flap 72 is connected to the inner side of the connecting frame 40 by sewing, bonding or hot pressing, so that the opposite two end edges of the flap 72 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 intersection of the second annular support frame 50 and the connecting frame 40. Two opposite sides of the flap body 72 extend to two opposite sides of the connecting framework 40, that is, two opposite side edges of the flap body 72 cover two opposite edges of the notch 401. The first waveform supporting rod 43 fixed on the valve body 72 can increase the supporting strength, prevent the connecting framework 40 from deforming due to the compression of the vein, and prevent the valve leaflet 74 from losing the function of the one-way valve.

In other embodiments, the first, second and third petals 721, 723 and 725 may be split structures, and the first, second and third petals 721, 723 and 725 are respectively connected to the first wave-shaped supporting rod 43, the first connecting rod 45 and the second connecting rod 46 by sewing, bonding or hot-pressing, so that the first, second and third petals 721, 723 and 725 are integrated.

As shown in fig. 4 and 10, leaflets 74 are attached to the inner side of body 72 (i.e., the side facing away from connecting frame 40) by sewing, gluing, or heat staking to create a one-way pathway for blood to pass through venous valve prosthesis 100, i.e., leaflets 74 act as one-way valves. The leaflet 74 and the valve body 72 enclose a first region 75 and a second region 76, the first region 75 corresponds to one part of the sinus region 403, the second region 76 corresponds to the other part of the sinus region 403, the first region 75 and the second region 76 are positioned at two opposite sides of the leaflet 74, and the leaflet 74 covers the first region 75. One of the first region 75 and the second region 76 is in communication with the first lumen 35 of the first annular support skeleton 30. In one embodiment, the first region 75 is the region of the leaflet 74 that is arched to communicate with the first lumen 35 of the first annular support frame 30, and the second region 76 is the region of the leaflet 74 that is arched to communicate with the third lumen 55 of the second annular support frame 50.

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

In this embodiment, the valve assembly 70 further includes a cover film disposed on the circumferential wall of the support body, and the cover film may be disposed on the inner surface or the outer surface of the support body, and each cover film 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 support frame 50, the first coating 77 is sewn, bonded or hot-pressed on the first annular support frame 30, and one side of the first coating 77 close to the connection frame 40 is connected to the flap 72; the second cover film 78 is attached to the second ring support frame 50 by sewing, bonding, or heat pressing, and the second cover film 78 is attached to the flap 72 on a side thereof adjacent to the attachment frame 40. Because the first annular supporting framework 30 is fixed on the first covering film 77, and the second annular supporting framework 50 is fixed on the second covering film 78, the supporting strength can be increased, and the anchoring force of the first annular supporting framework 30 and the second annular supporting framework 50 after being implanted into the vein can be enhanced.

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

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

As shown in fig. 1 and 2, the venous valve prosthesis 100 is implanted in a proper position of the lumen 301 of the venous vessel 300 through a delivery device, the first annular supporting framework 30 and the second annular supporting framework 50 are anchored on the inner wall of the venous vessel 300, the connecting framework 40 protrudes outwards against the inner wall of the venous vessel 300, the notch 401 can reduce the over-expansion of the protrusion 41 of the connecting framework 40 on the venous vessel 300, and is beneficial to better anchoring of the first annular supporting framework 30 and the second annular supporting framework 50 on the venous vessel 300, so that the venous valve prosthesis 100 is not easy to displace after being implanted in the venous vessel 300. Because the grid holes 48 of the connecting framework 40 are larger than the grid holes 37 of the first annular supporting framework 30 and the grid holes 57 of the second annular supporting framework 50, and the connecting framework 40 is circumferentially provided with the notches 401, the venous valve prosthesis 100 has certain flexibility as a whole, the venous valve prosthesis 100 is easy to bend at the connecting framework 40, and the venous valve prosthesis 100 can more easily pass through tortuous complex blood vessels, so that the surgical risk is reduced. Blood in lumen 301 of venous vessel 300 flows downstream from the proximal end to the distal end, i.e., from third lumen 55 of second annular support frame 50 to first lumen 35 of first annular support frame 30, and the downstream blood impinges on leaflets 74 moving to the side away from gaps 401, and leaflets 74 separate from the inner wall of venous vessel 300 to open a one-way pathway for venous valve prosthesis 100 (as shown in fig. 1). When the leaflet 74 is arched by the impact of the backflow of blood in the vein 300 (as shown in fig. 2), the leaflet 74 moves toward the notch 401 by the impact of the backflow of blood and abuts against the inner wall of the vein 300 around the notch 401, that is, a region where a vortex is formed in the first region 75, thereby effectively preventing the backflow of blood and local thrombus formation. When the blood in the venous blood vessel 300 flows downstream again, the valve flap 74 is pushed by the downstream blood to move to the side away from the gap 401, referring to fig. 4, and the valve flap 74 extrudes the blood in the first region 75 to make the blood in the first region 75 flow to the first lumen 35; therefore, due to the existence of the second region 76, when the backflow disappears, the forward flow one-way passage is rapidly opened, and the forward flow blood flow is increased.

In other embodiments, the venous valve prosthesis 100 is provided with a visualization structure, specifically, one of the first annular support skeleton 30, the connecting skeleton 40 and the second annular support skeleton 50 is provided with a visualization structure, or two of the first annular support skeleton 30, the connecting skeleton 40 and the second annular support skeleton 50 are provided with a visualization structure, or the first annular support skeleton 30, the connecting skeleton 40 and the second annular support skeleton 50 are respectively provided with a visualization structure. The visualization structure is a visualization wire or a visualization point continuously or discontinuously wound on the venous valve prosthesis 100, or the interventional venous valve stent 20 is made of an alloy doped with a visualization material, for example, the nickel-titanium alloy wire is a tantalum-containing nickel-titanium alloy wire.

Preferably, at least one circle of developing wires or developing points is surrounded by one of the first wave-shaped supporting rod 43, the second wave-shaped supporting rod 33 adjacent to the connecting skeleton 40, and the third wave-shaped supporting rod adjacent to the connecting skeleton 40. The position of the annular developing structure can be clearly observed through an imaging device in the operation process, and the venous valve prosthesis 100 can be conveniently and quickly inserted into the inner cavity 301 of the venous vessel 300. The developer material includes, but is not limited to, gold, 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 turn of developing wires or developing points, which are fixed on the first covering film 77 and/or the second covering film 78 by sewing, heat pressing or attaching.

Referring to fig. 11, a venous valve prosthesis 100a according to a second embodiment of the present invention is similar in structure to the first embodiment, except that: the venous valve prosthesis 100a is the venous valve prosthesis 100 of the first embodiment in which the first and second coating films 77 and 78 are omitted. Specifically, the valve assembly 70 includes only a valve body 72 disposed inside the connecting frame 40 and a valve leaflet 74 connected to the inner side surface of the valve body 72. The venous valve prosthesis 100a can save the manufacturing cost by omitting the first coating film 77 and the second coating film 78.

Referring to fig. 12 and 13, a venous valve prosthesis according to a third embodiment of the present invention has a structure similar to that of the first embodiment, except that: the structure of the connecting skeleton 40a of the interventional venous valve stent 20a in the third embodiment is different from the structure of the connecting skeleton 40 of the interventional venous valve stent 20 in the first embodiment: specifically, the connecting skeleton 40a includes a plurality of support rods 435, the plurality of support rods 435 extend along an axial direction of the first annular support skeleton 30 or the second annular support skeleton 50 and are arranged at intervals along a circumferential direction of the first annular support skeleton 30 or the second annular support skeleton 50, and gaps 401 are formed in an interval area between two adjacent support rods 435 in the circumferential direction of the first annular support skeleton 30 or the second annular support skeleton 50. Wherein, the gap 401 formed by the spacing region between two adjacent support rods 435 with the largest spacing distance can be used for the valve leaflet 74 to pass through to abut against the vein blood vessel wall, and the middle part of at least one support rod 435 bends outwards to form a bulge 41.

In this embodiment, each supporting rod 435 includes a middle bending section 436, a proximal vertical section 437 disposed at a proximal end of the middle bending section 436, and a distal vertical section 438 disposed at a distal end of the middle bending section 436, wherein an end of the proximal vertical section 437 away from the middle bending section 436 is connected to the first annular supporting framework 30, and an end of the distal vertical section 438 away from the middle bending section 436 is connected to the second annular supporting framework 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, the middle of the middle bent section 436 bends outward, the middle bent sections 436 form the protruding portion 41, the inner side of the protruding portion 41 forms the sinus region 403, and the valve assembly 70 is disposed in the sinus region 403.

The proximal vertical segments 437 of the plurality of struts 435 are respectively connected to the second troughs 334 of the adjacent second wave-shaped struts 33, and the distal vertical segments 438 are respectively connected to the third peaks 532 of the adjacent third wave-shaped struts 53; the gap 401 is formed between the second wave trough 334 of the adjacent second wave supporting bar 33 and the third wave peak 532 of the third wave supporting bar 53, which are not connected by the supporting bar 435.

In this embodiment, the number of the support rods 435 is six, and they are arranged at intervals within 270 degrees in the circumferential direction of the interventional venous valve stent 20 a. In the area where the support bars 435 are arranged, the circumferential interval angle between two adjacent support bars 435 is 45 degrees, and at this time, the 90-degree interval where the support bars 435 are not arranged of the interventional venous valve stent 20a forms the notch 401 through which the valve leaflet 74 can pass, that is, the opening circumferential angle of the notch 401 is 90 degrees.

Referring to fig. 14 and 15, a venous valve prosthesis 100b according to a fourth embodiment of the present invention has a structure similar to that of the venous valve prosthesis 100 according to the first embodiment, except that: the venous valve prosthesis 100b of the fourth embodiment is the venous valve prosthesis 100 of the first embodiment, in which the second annular support frame 50 and the second cover 78 are omitted, that is, the interventional venous valve stent includes only the first annular support frame 30 and the connection frame 40 connected to the end of the first annular support frame 30; the valve assembly 70 only includes a valve body 72, a valve leaflet 74 and a first covering film 77, the valve body 72 is sewn, adhered or hot pressed on the connecting frame 40, the valve leaflet 74 is sewn, adhered or hot pressed on the valve body 72, the first covering film 77 is sewn, adhered or hot pressed on the first annular supporting frame 30, and the valve body 72 is connected to the first covering film 77. The venous valve prosthesis 100b saves manufacturing costs by omitting the second annular support scaffold 50 and the second cover film 78. It is understood that the first coating 77 may be omitted in this embodiment.

The foregoing is illustrative of embodiments of the present invention, and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the embodiments of the present invention and are intended to be within the scope of the present invention.

Claims (19)

1. An interventional venous valve stent capable of radial compression and expansion, comprising:

a support body comprising a first annular support skeleton; and

connect the skeleton, connect in the tip of first annular support skeleton, connect the skeleton edge the circumference setting of first annular support skeleton is in connect the circumference disconnection of skeleton and form the breach, connect the at least partial evagination of skeleton and form the bulge, the inboard formation sinus district of bulge.

2. The interventional venous valve stent of claim 1, wherein the connecting framework comprises a first corrugated support rod extending circumferentially of the first annular support framework, the first corrugated support rod comprising a plurality of first corrugated rods connected end-to-end, at least some of the first corrugated rods having a middle portion that is convex to form at least a portion of the bulge.

3. The interventional venous valve stent of claim 2, wherein the first wave shaped support struts are plural in number, and the plural first wave shaped support struts are arranged along an axial direction of the connecting skeleton.

4. The interventional venous valve stent of claim 2, wherein the first wave shaped support strut has a first peak proximal to the first annular support skeleton and a first valley distal from the first annular support skeleton, the first peak and the first valley formed between adjacent ones of the first wave struts; the connecting framework comprises a plurality of first connecting rods extending along the axial direction of the connecting framework, and the first connecting rods are arranged between the first wave crests and the first annular supporting framework.

5. The interventional venous valve stent of claim 4, wherein the connecting skeleton further comprises a plurality of second connecting rods extending in an axial direction of the connecting skeleton, the second connecting rods being connected with first troughs in the connecting skeleton distal from the first annular support skeleton.

6. The interventional venous valve stent of claim 4, wherein a middle portion of each of the first wave bars is convex to form a portion of the bulge; each of the first connecting rods gradually inclines outwards in a direction from one end of the first connecting rod close to the first annular supporting skeleton to one end of the first connecting rod far away from the first annular supporting skeleton so as to be connected to the corresponding first wave crest, and the first connecting rods are formed as a part of the bulge.

7. The interventional venous valve stent of claim 4, wherein a middle portion of each of the first wave bars is convex to form a portion of the bulge; the head rod includes first vertical section and first crooked section, first vertical section is followed the axial extension of first cyclic annular support skeleton by the head rod is close to the one end of first cyclic annular support skeleton is to keeping away from in the direction of the one end of first cyclic annular support skeleton, first crooked section is outside crooked gradually to connect in corresponding first crest, first crooked section forms a part of bulge.

8. The interventional venous valve stent of claim 4, wherein the first annular support skeleton comprises a plurality of second wave-shaped support struts arranged sequentially along an axial direction of the first annular support skeleton; the second waveform supporting rod comprises a plurality of second wave crests, a plurality of second wave troughs and a second wave rod which connects two adjacent second wave crests with the second wave troughs, and the adjacent first wave crests are connected with the second wave troughs through the first connecting rods.

9. The interventional venous valve stent of claim 8, wherein each two adjacent first connecting rods and the first and corresponding second wave-shaped support rods enclose a first grid of holes, each two adjacent second wave-shaped support rods form a plurality of second grid of holes, and the first grid of holes has a larger aperture value than the second grid of holes.

10. The interventional venous valve support of claim 1, wherein the connecting framework comprises a plurality of support rods, the plurality of support rods extend along an axial direction of the first annular support framework and are arranged at intervals along a circumferential direction of the first annular support framework, in the circumferential direction of the first annular support framework, a gap region between two adjacent support rods forms the notch, and a middle portion of at least one support rod bends outwards to form the protruding portion.

11. The interventional venous valve stent of any one of claims 1 to 10, wherein the support body further comprises a second annular support framework, the connecting framework being disposed between the first annular support framework and the second annular support framework, the connecting framework being disposed circumferentially of the second annular support framework.

12. The interventional venous valve stent of claim 11, wherein an outer diameter of the projections is greater than an outer diameter of the first annular support scaffold and an outer diameter of the second annular support scaffold.

13. The interventional venous valve stent of claim 11, wherein the axial direction of the first annular support scaffold is parallel to the axial direction of the second annular support scaffold in a natural state.

14. The interventional venous valve stent of claim 11, wherein in a natural state, two portions of a lumen of the venous valve stent divided by a reference plane are symmetrical about the reference plane, a normal direction of the reference plane is parallel to an axial direction of the first annular support skeleton, and a set of all points forming a maximum inner diameter of the connecting skeleton lies within the reference plane.

15. The interventional venous valve stent of claim 1, wherein the maximum opening angle of the gap in the circumferential direction of the connecting skeleton ranges between 90 degrees-180 degrees.

16. The interventional venous valve stent of claim 1, wherein the projections extend from one side of the connecting skeleton to an opposite side in a circumferential direction of the connecting skeleton.

17. A venous valve prosthesis for implantation in a venous vessel, the venous valve prosthesis comprising an interventional venous valve stent according to any one of claims 1-16 and a valve assembly comprising leaflets attached to the inside of the connecting framework, the leaflet covers at least part of the sinus region and is adapted to establish a one-way pathway in the venous vessel.

18. The venous valve prosthesis of claim 17, the valve assembly further comprising a valve body conforming to the inner surface of the connecting frame, the valve leaflet circumscribing the valve body with a first region corresponding to a portion of the sinus region and a second region corresponding to another portion of the sinus region, the first region and the second region being on opposite sides of the valve leaflet, one of the first region and the second region communicating with the lumen of the first annular support frame, the valve leaflet covering being disposed in the first region.

19. The venous valve prosthesis of claim 18, wherein the valve assembly further comprises a cover membrane disposed on a peripheral wall of the support body, each cover membrane being connected to the valve body.

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