Interventional venous valve stents and venous valve prostheses

Abstract

The present invention provides an interventional venous valve stent, comprising a support body and a connecting frame, wherein the support body comprises a first annular support frame, the connecting frame being connected to the end of the first annular support frame, the connecting frame being arranged along the circumference of the first annular support frame and being disconnected in the circumference of the connecting frame to form a notch, at least a portion of the connecting frame being convex outward to form a protrusion, the inner side of the protrusion forming a sinus area. The notch can give the interventional venous valve stent better flexibility, making it easier for the interventional venous valve stent to pass through complex and circuitous blood vessels, thereby reducing surgical risks; the leaflets cause the returning blood to form vortices in the area covered by the leaflets in the sinus area, preventing blood from flowing back, thereby improving the clinical effect of the venous valve prosthesis. The present invention also provides a venous valve prosthesis provided with the interventional venous valve stent.

Description

Technical Field

[0001] The present invention relates to the technical field of implantable blood vessels, in particular to an interventional venous valve stent and a venous valve prosthesis provided with the interventional venous valve stent. Background Art

[0002] Venous surgical disease is a common surgical condition, often occurring in the lower extremities. Its main clinical manifestations include varicose veins, limb swelling, and dystrophic skin lesions in the foot and girth, such as dermatitis, hyperpigmentation, and ulceration. The primary pathological cause is the loss of the unidirectional function of the venous valves due to pathogenic factors. Mild venous disease can impair daily life and work, while severe cases can lead to varying degrees of disability. Consequently, the treatment of lower extremity venous valve disease is receiving increasing attention. Currently, most clinical treatments for this condition are conservative, such as medication and pressure pumps. Surgical interventions, such as femoral venous valve repair and reconstruction, have unsatisfactory clinical results. In particular, for patients with severely damaged venous valves or congenital avalvular disease, venous valve transplantation appears to be the only option. Currently, autologous venous valve prostheses with valves are used clinically. However, these prostheses suffer from poor anchoring force, insufficient compliance, and localized thrombosis after implantation, resulting in suboptimal clinical outcomes. Summary of the Invention

[0003] The purpose of the present invention is to provide a venous valve prosthesis and an interventional venous valve stent with better clinical effects.

[0004] In order to solve the above technical problems, the present invention provides an interventional venous valve stent capable of radial compression and expansion, comprising a support body and a connecting frame, the support body comprising a first annular support frame, the connecting frame being connected to the end of the first annular support frame, the connecting frame being arranged along the circumference of the first annular support frame and being broken in the circumference of the connecting frame to form a notch, at least part of the connecting frame convexly forming a protrusion, and the inner side of the protrusion forming a sinus area.

[0005] The present invention also provides a venous valve prosthesis for implantation in a venous vessel. The venous valve prosthesis includes an interventional venous valve stent and a valve assembly. The valve assembly includes a leaflet connected to the inner side of the connecting skeleton. The leaflet cover is arranged in at least a portion of the sinus area and is used to construct a one-way passage in the venous vessel.

[0006] The notch on the connecting frame of the venous valve prosthesis provided by the present invention reduces the excessive expansion of the venous vessel wall by the protruding part of the connecting frame, and the notch can make the interventional venous valve stent have better flexibility, making it easier for the interventional venous valve stent to pass through tortuous and complex blood vessels, thereby reducing the risk of surgery; in addition, the leaflets are in a suspended state under the action of vortex and do not adhere to the venous wall, thereby reducing the risk of adhesion, and the vortex formed can also avoid the risk of blood flow retention and thrombosis at the root of the leaflets; the leaflets move toward the notch under the impact of blood reflux in the venous vessels and abut against the inner wall of the venous vessels around the notch, so that the returning blood forms a vortex in the area covered by the leaflets in the sinus area, preventing blood from retreating and avoiding the risk of blood flow retention and thrombosis at the root of the leaflets; thereby achieving better clinical effects of the venous valve prosthesis. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the implementation. Obviously, the drawings described below are some implementations of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0008] Figure 1 is a schematic diagram of the venous valve prosthesis provided by the first embodiment of the present invention in use;

[0009] Figure 2 Schematic diagram of the anti-reflux state of the venous valve prosthesis provided by the first embodiment of the present invention;

[0010] Figure 3 is a schematic diagram of the three-dimensional structure of the venous valve prosthesis provided by the first embodiment of the present invention;

[0011] Figure 4 yes Figure 3 Front view of the venous valve prosthesis in;

[0012] Figure 5 is a schematic diagram of one of the usage states of the venous valve prosthesis provided by the first embodiment of the invention;

[0013] Figure 6 This is another schematic diagram of the venous valve prosthesis provided by the first embodiment of the invention in use;

[0014] Figure 7 yes Figure 3 Left view of the interventional venous valve stent of the venous valve prosthesis;

[0015] Figure 8 yes Figure 3 Front view of the interventional venous valve stent;

[0016] Figure 9 yes Figure 3 A schematic diagram of the three-dimensional exploded structure of the valve component;

[0017] Figure 10 yes Figure 9 Schematic diagram of the three-dimensional assembly of the valve component;

[0018] Figure 11 is a schematic diagram of the three-dimensional structure of a venous valve prosthesis provided by a second embodiment of the present invention;

[0019] Figure 12 This is a front view of an interventional venous valve stent provided by a third embodiment of the present invention;

[0020] Figure 13 yes Figure 12 Left view of the interventional venous valve stent;

[0021] Figure 14 1 is a schematic diagram of the three-dimensional structure of an interventional venous valve stent provided by a fourth embodiment of the present invention;

[0022] Figure 15 yes Figure 14 Front view of the interventional venous valve stent. DETAILED DESCRIPTION

[0023] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without creative work are within the scope of protection of the present invention.

[0024] In addition, the following descriptions of the embodiments refer to the accompanying drawings to illustrate specific embodiments in which the present invention may be implemented. Directional terms used in the present invention, such as "upper," "lower," "front," "back," "left," "right," "inner," "outer," and "side," are used solely with reference to the directions in the accompanying drawings. Therefore, the use of directional terms is intended to better and more clearly illustrate and understand the present invention, and is not intended to indicate or imply that the device or component referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limiting the present invention.

[0025] In the description of the present invention, the "proximal end" of the present invention refers to the end close to the heart position, and the "distal end" refers to the end far away from the heart position. This definition is only for the convenience of expression and should not be understood as a limitation of the present invention.

[0026] Please also refer to Figure 1 and Figure 2The present invention provides a venous valve prosthesis 100 for implantation in a vein 300 to construct a one-way passage in the vein 300 to prevent blood reflux. Figure 1 The figure shows the venous valve prosthesis 100 in use. At this time, under the impact of the downstream blood flow from the proximal end to the distal end, the blood flow path of the venous valve prosthesis 100 is opened. Figure 2 The diagram shows the anti-reflux state of the venous valve prosthesis 100 . At this time, under the impact of the reverse blood flow from the distal end to the proximal end, the blood flow path of the venous valve prosthesis 100 is closed.

[0027] See also Figures 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 has a mesh tube structure and is radially compressible and expandable. 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. The connecting frame 40 is located between the first and second annular support frames 30 and 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 frame 40 is arranged along the circumference of the first and second annular support frames 30 and 50, and is interrupted along the circumference of the connecting frame 40 to form a notch 401. At least a portion of the connecting frame 40 protrudes outward to form a protrusion 41, and the inner side of the protrusion 41 forms a sinus region 403. It should be noted that the so-called “sinus area”, ie 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 of the inner cavity enclosed by the connecting frame 40 is increased.

[0028] The valve assembly 70 includes a valve body 72 connected to the inner side of the connecting frame 40 and leaflets 74 connected to the inner side of the valve body 72. The leaflets 74 cover 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 leaflets 74 are connected to the side of the valve body 72 facing away from the connecting frame 40. Specifically, the valve body 72 is sutured, bonded, or heat-pressed to the connecting frame 40, and one edge of the leaflet 74 is sutured, bonded, or heat-pressed to the valve body 72, so that the leaflets 74 and the portion of the valve body 72 covered by the leaflets 74 enclose a vortex-containing space with a V-shaped cross-section, wherein the cross-section is parallel to the axial direction of the interventional venous valve stent 20.

[0029] After the venous valve prosthesis 100 is implanted in the vein 300, the interventional venous valve stent 20 adheres to the inner membrane of the vein 300, so that the interventional venous valve stent 20 is stably anchored in the vein 300, preventing the blood in the vein 300 from leaking out from between the interventional venous valve stent 20 and the inner membrane of the vein 300. That is, all the blood flows in the inner cavity of the interventional venous valve stent 20. Figure 2 When the blood in the vein 300 flows from the distal end to the proximal end, the leaflet 74 moves toward the notch 401 under the impact of the blood flow until the leaflet 74 abuts against the inner wall of the vein 300 around the notch 401, and the leaflet 74 closes the vein 300, effectively preventing blood from flowing back. Figure 1 When the blood in the vein 300 flows from the proximal end to the distal end, the blood flow impacts the valve leaflet 74 to move toward the side away from the notch 401 and open a one-way passage in the vein 300.

[0030] For further explanation, please refer to Figure 3 and Figure 4 As shown, the leaflet 74 includes a fixed edge 742 and a free edge 745, wherein the fixed edge 742 is fixedly connected to the leaflet body 72 and the free edge 745 is freely suspended. Figure 2 ) under the impact of blood backflow in the vein 300, the free edge 745 can move toward the notch 401 and abut against the vein wall around the notch 401 to form a one-way passage in the vein 300. Figure 1 ), the free edge 745 moves toward the sinus area 403, and the free edge 745 separates from the venous vessel wall to open a one-way passage in the venous vessel 300.

[0031] It should be noted that under the impact of blood backflow in the vein 300, the leaflet 74 forms an arched structure to block backflow, referring to Figure 5 There can be a small gap 404 between the free edge 745 and the vein wall. In this case, the free edge 745 does not abut against the vein wall, thereby reducing the risk of adhesion between the free edge 745 and the vessel wall tissue. The small gap 404 between the free edge 745 and the vein wall does not affect the leaflet 74 from blocking most of the backflow blood flow. In addition, under the impact of the backflow of blood in the vein 300, the free edge 745 can be located not only near the area where the notch 401 is located, but also in the area where the notch 401 is located. Figure 6 , the free edge 745 can also be located in the inner cavity enclosed by the first annular support frame 30. In other embodiments, the free edge 745 can also be located in the inner cavity enclosed by the second annular support frame 50, and the present invention is not limited thereto.

[0032] The venous valve prosthesis 100 provided by the present invention has a sinus region 403 formed on the inner side of the protruding portion 41 of the connecting frame 40, and the connecting frame 40 is circumferentially interrupted to form a notch 401. The notch 401 reduces the metal coverage of the protruding portion 41, thus preventing excessive expansion of the venous vessel wall by the protruding portion 41 of the connecting frame 40, thereby reducing excessive stimulation of the vascular endothelium. Furthermore, the notch 401 enhances the flexibility of the interventional venous valve stent 20, making it easier to navigate complex and circuitous blood vessels and reducing surgical risks.

[0033] Secondly, during the process of the downstream blood in the vein 300 flowing along the one-way path ( Figure 1 ), the area of ​​the sinus region 403 covered by the leaflet 74 forms a vortex, which is beneficial to the pressure balance of the leaflet 74. At this time, the free edge 745 of the leaflet 74 is in a suspended state under the action of the vortex and does not adhere to the vein wall, thereby reducing the risk of adhesion. The formed vortex can also avoid the risk of blood flow retention and thrombosis at the root of the leaflet 74; the leaflet 74 moves toward the notch 401 under the impact of the blood reflux in the vein 300 and abuts against the inner wall of the vein 300 around the notch 401 ( Figure 2 ), so that the backflowing blood forms a vortex in the area of ​​the sinus region 403 covered by the leaflet 74, preventing the blood from retreating and avoiding the risk of blood flow retention and thrombosis formation at the root of the leaflet 74.

[0034] In addition, the interventional venous valve stent 20 is a nickel-titanium alloy mesh columnar stent. The interventional venous valve stent 20 has greater rigidity. After the interventional venous valve stent 20 is implanted in the vein 300, the interventional venous valve stent 20 always maintains a fixed shape, and the changes in the pressure of the vein 300 will not affect the valve body 72 and then the function of the leaflets 74. The first annular support frame 30 and the second annular support frame 50 have a higher radial support force, which can better anchor the interventional venous valve stent 20 to the vein 300, reduce the stimulation to the endothelium of the vein 300, and prevent excessive proliferation of the endothelium.

[0035] In one embodiment, the connecting skeleton 40 is a non-enclosed mesh stent continuously arranged in the circumferential direction. The so-called "continuous" means that the connecting skeleton 40 continuously extends a certain angle in the circumferential direction without being interrupted. Specifically, Figure 7 and Figure 8As shown, the connecting frame 40 includes a sinusoidal first corrugated support rod 43. The first corrugated support rod 43 comprises a plurality of first corrugated rods 430 connected end to end. The central portions of at least some of the first corrugated rods 430 protrude outward to form at least a portion of the protrusion 41. That is, the central portion of the first corrugated rod 430 that protrudes outward may form part of the protrusion 41, or may form the entirety of the protrusion 41. In this embodiment, there is only one first corrugated support rod 43, which is arranged along the circumference of the first annular support frame 30. The first corrugated support rod 43 is interrupted circumferentially to form the notch 401, and the central portion of each first corrugated rod 430 protrudes outward.

[0036] The first corrugated support rod 43 has a first crest 432 proximal to the first annular support frame 30 and a first trough 434 distal to the first annular support frame 30. Both the first crest 432 and the first trough 434 are formed between two adjacent first corrugated rods 430. The connecting frame 40 further includes a plurality of first connecting rods 45 extending axially along the connecting frame 40. The first connecting rods 45 are disposed between the first crest 432 and the first annular support frame 30. In this embodiment, each first crest 432 of the first corrugated support rod 43 is connected to a first connecting rod 45, and the ends of the first connecting rods 45 distal to the first corrugated support rod 43 are connected to the first annular support frame 30.

[0037] Preferably, each first connecting rod 45 gradually tilts outward from the end of the first connecting rod 45 closest to the first annular support frame 30 to the end farther from the first annular support frame 30 to connect to the corresponding first wave crest 432. The first connecting rod 45 forms part of the protrusion 41, that is, the first connecting rod 45 forms the proximal portion of the protrusion 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 axially along the first annular support frame 30. The first curved section 454 gradually curves outward from the first vertical section 452 to the first corrugated support rod 43 of the connecting frame 40 to connect to the corresponding first wave crest 432. The first curved section 454 forms part of the protrusion 41, that is, the first curved section 454 forms the proximal portion of the protrusion 41. The inner cavity enclosed by the first vertical sections 452 has a constant diameter. The first vertical section 452 does not have an outwardly convex structure and does not belong to the protrusion 41.

[0038] In this embodiment, the connecting frame 40 further includes a plurality of second connecting rods 46 extending axially along the connecting frame 40. One end of each second connecting rod 46 is connected to a first trough 434 of the connecting frame 40, distal from the first annular support frame 30, and the other opposite end of each second connecting rod 46 is connected to the distal end of the second annular support frame 50. Specifically, each first trough 434 of the first corrugated support rod 43 is connected to a second connecting rod 46, and the end of each second connecting rod 46 distal from the first corrugated support rod 43 is connected to the second annular support frame 50.

[0039] Preferably, each second connecting rod 46 gradually tilts outward from the end of the second connecting rod 46 proximal to the second annular support frame 50 to the end distal to the second annular support frame 50 to connect to the corresponding first trough 434. The second connecting rod 46 forms part of the protrusion 41, i.e., the second connecting rod 46 forms the distal end 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 axially along the second annular support frame 50. The second curved section 464 gradually curves outward from the second vertical section 462 to the first corrugated support rod 43 of the connecting frame 40 to connect to the corresponding first trough 434. The second curved section 464 forms part of the protrusion 41, i.e., the second curved section 464 forms the distal end of the protrusion 41. The inner cavity enclosed by the second vertical sections 462 has a constant diameter. The first vertical section 462 does not have an outwardly convex structure and does not belong to the protrusion 41.

[0040] In other embodiments, the connecting skeleton 40 may not include the first connecting rod 45 and the second connecting rod 46. In this case, the first wave peak 432 of the first corrugated support rod 43 can be directly connected to the first annular support skeleton 30, and the first wave valley 434 of the first corrugated support rod 43 can be directly connected to the second annular support skeleton 50.

[0041] In other embodiments, there are multiple first corrugated support rods 43, and the multiple first corrugated support rods 43 are arranged along the axial direction of the connecting frame 40. The first wave crests 432 of each two adjacent first corrugated support rods 43 are connected to 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 formed by the two adjacent first corrugated support rods 43 is larger than the inner diameter of the grid of the first annular support frame 30 and the inner diameter of the grid of the second annular support frame 50.

[0042] like Figure 7 and Figure 8As shown, the first annular support frame 30 includes a plurality of sinusoidal second corrugated support rods 33, which are arranged sequentially along the axial direction of the first annular support frame 30. Each second corrugated support rod 33 includes a plurality of second wave crests 332, a plurality of second wave troughs 334, and a second wave rod 330 connecting two adjacent second wave crests 332 and second wave troughs 334. Adjacent first wave crests 432 and second wave troughs 334 are connected by first connecting rods 45. That is, each first wave crest 432 of a first corrugated support rod 43 is connected to the second wave trough 334 adjacent to the second corrugated support rod 33 adjacent to the first corrugated support rod 43 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. The plurality of second corrugated support rods 33 enclose a first inner cavity 35 extending in the axial direction. The plurality of second corrugated support rods 33 form an annular grid structure, and each pair of adjacent second corrugated support rods 33 form a plurality of grid holes 37.

[0043] In this embodiment, the first annular support frame 30 is connected along the axial direction of the first annular support frame 30 by three second corrugated support rods 33. In this embodiment, each second corrugated support rod 33 is laser-engraved from a nickel-titanium alloy, and the second corrugated support rods 33 have nine sinusoidal waves. In other embodiments, the number of second corrugated support rods 33 and the number of sinusoidal waves can be other numbers.

[0044] like Figure 8 As shown, the connecting frame 40 is provided with a second inner cavity 47 that communicates with the first inner cavity 35. Each adjacent two first connecting rods 45, the first corrugated support rod 43, and the corresponding second corrugated support rod 33 form a grid of holes 48; the aperture of the grid holes 48 is larger than the aperture of the grid holes 37 of the first annular support frame 30. In this embodiment, the connecting frame 40 has a gradient section 470. The inner diameter of the second inner cavity 47 (i.e., the gradient section 470) gradually increases from both sides of the gradient section 470 to the middle of the gradient section 470. The gradient section 470 can be understood as corresponding to the protrusion 41 in the connecting frame 40. A notch 401 is provided in the gradient section 470 of the connecting frame 40 and communicates with the second inner cavity 47.

[0045] like Figure 7As shown, the second annular support frame 50 includes a plurality of sinusoidal third corrugated support rods 53, which are arranged sequentially along the axial direction of the second annular support frame 50. Each third corrugated support rod 53 includes a plurality of third wave crests 532, a plurality of third wave troughs 534, and a third wave rod 530 connecting two adjacent third wave crests 532 and third wave troughs 534. Adjacent first wave troughs 434 and third wave crests 532 are connected by second connecting rods 46. In other words, each first wave trough 434 of the first corrugated support rod 43 is connected to the adjacent third wave crest 532 of the third corrugated support rod 53 adjacent to the first corrugated support rod 43 by the second connecting rod 46. Each third corrugated support rod 53 is arranged in a circle along the circumference of the second annular support frame 50. The plurality of third corrugated support rods 53 form an annular grid structure, with each pair of adjacent third corrugated support rods 53 forming a plurality of grid holes 57. The aperture of each grid hole 57 of the second annular support frame 50 is smaller than the aperture of the grid hole 48.

[0046] In this embodiment, the second annular support frame 50 is connected along the axial direction of the second annular support frame 50 by three third corrugated support rods 53. In this embodiment, each third corrugated support rod 53 is laser-engraved from nickel-titanium alloy, and the third corrugated support rods 53 have nine sinusoidal waves. In other embodiments, the third corrugated support rods 53 and the number of sinusoidal waves can be other numbers.

[0047] The second annular support frame 50 has a third inner cavity 55. Specifically, a plurality of third corrugated support rods 53 define the third inner cavity 55, extending axially. Each pair of adjacent third corrugated support rods 53 forms a plurality of grid holes 57. Each pair of adjacent second connecting rods 46, the first corrugated support rods 43, and the corresponding third corrugated support rods 53 also define a grid hole 48. The third inner cavity 55 communicates with the second inner cavity 47. The diameter of the grid holes 48 is larger than that of the grid holes 57 of the second annular support frame 50.

[0048] In this embodiment, the inner diameter of the transition section 470 at the end closest to the first annular support frame 30 is equal to the inner diameter of the first inner cavity 35, or the inner diameter of the transition section 470 at the end closest to the second annular support frame 50 is equal to the inner diameter of the third inner cavity 55. The outwardly convex central portion of the first corrugated support bar 43 encloses the first corrugated support bar 43 to form at least a portion of the transition section 470. In other embodiments, the inner diameters of the first inner cavity 35 and the third inner cavity 55 are equal. In this case, the inner diameters of the transition section 470 on opposite sides are equal to the inner diameters of the first inner cavity 35 and the second inner cavity 55.

[0049] Optionally, in the direction from the ends to the middle of the connecting frame 40 (i.e., reference plane α), the first connecting rod 45 gradually tilts outward to connect to the corresponding first wave crest 432, and the second connecting rod 46 gradually tilts outward to connect to the corresponding first wave trough 434; the first connecting rod 45, the first corrugated support rod 43, and the second connecting rod 46 together form a gradual transition 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 portion of the first connecting rod 45 (i.e., the first curved section 454), the portion of the second corrugated rod 46 (i.e., the second curved section 464), and the first corrugated support rod 43 together form the gradual transition section 470.

[0050] like Figure 8 As shown, the maximum outer diameter D1 of the protrusion 41 is greater 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 support frame 30 is equal to the outer diameter D3 of the second annular support frame 50; the outer diameter D2 ranges from 5 mm to 30 mm, and the maximum outer diameter D1 protrudes from the outer diameter D2 of the first annular support frame 30 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 be different. 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 this embodiment, the axial length L1 of the connecting frame 40, 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, all being 10 mm.

[0051] Optionally, the first annular support frame 30, the connecting frame 40, and the second annular support frame 50 can be laser-engraved, integrated stents made of nickel-titanium alloy. In this embodiment, 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 are 0.3 mm wide and 0.35 mm thick; the total axial length of the interventional venous valve stent 20 is approximately 30 mm.

[0052] In other embodiments, the first annular support frame 30 , the connecting frame 40 , and the second annular support frame 50 can be laser-engraved from different nickel-titanium alloys and then fixedly connected together.

[0053] In the natural state, the axial directions of the first annular support frame 30, the axial directions of the connecting frame 40, and the axial directions of the second annular support frame 50 are parallel to each other. Preferably, in the 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 refers to the interventional venous valve stent 20 being in a released state free from radial external forces.

[0054] In other embodiments, in a natural state, the axis of the first annular support frame 30 , the axis of the connecting frame 40 , and the axis of the second annular support frame 50 coincide with each other.

[0055] like Figure 7 As shown, in the natural state, the two parts obtained by dividing the middle part of the venous valve stent 20 by the reference plane α, and the two parts obtained by dividing the inner cavity of the venous valve stent 20 by the reference plane α are all symmetrical about the reference plane α, the normal direction of the reference plane α is parallel to the axial direction of the first annular support skeleton 30 or the second annular support skeleton 50, and the set of all points in the connecting skeleton 40 used to form the maximum inner diameter of the connecting skeleton 40 is located within the reference plane α.

[0056] like Figure 8 As shown, in the natural state, the two parts of the venous valve stent 20 divided by the reference plane β are symmetrical about the reference plane β, the reference plane β is parallel to the 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 notch 401.

[0057] like Figure 3 As shown, 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 skeleton 40 to the other opposite side along the circumference of the connecting skeleton 40, that is, the opposite sides of the protrusion 41, the part of the first annular support skeleton 30 close to the connecting skeleton 40 that is not connected to the first connecting rod 45, and the part of the second annular support skeleton 50 close to the connecting skeleton 40 that is not connected to the second connecting rod 46 form the notch 401.

[0058] In other embodiments, the support body and the connecting skeleton 40 are made of braided wire, that is, the first annular support skeleton 30, the connecting skeleton 40 and the second annular support skeleton 50 are made of braided wire. Specifically, the interventional venous valve stent 20 is woven by a superelastic nickel-titanium wire, and the superelastic nickel-titanium alloy wire can be selected in the wire diameter (i.e., diameter) range of 0.1mm to 0.6mm. The middle part of the connecting skeleton 40 is protruded outward to form a protrusion, and the inner side of the protrusion forms a sinus area; specifically, the sinus area is obtained by shaping the mold inserted into the connecting skeleton 40 and then heat-treating it. The protrusion thus provided is a full circle of annularity, and the full circle of protrusions will reduce the anchoring force at both ends of the interventional venous valve stent 20, so a notch can be formed by cutting a part of the full circle of protrusions to enhance the anchoring force at both ends of the interventional venous valve stent 20.

[0059] In other embodiments, the cross-sectional shape of the first annular support frame 30 and the second annular support frame 50 is elliptical or fusiform, etc. It should be noted that, to clearly define the cross-sectional shape, the normal direction of the cross-sectional shape is parallel to the axial direction of the first annular support frame 30 and the axial direction of the second annular support frame 50.

[0060] Please also refer to Figure 3-Figure 4 and Figure 9-10 The petal body 72 includes a first petal 721 that fits on the inner surface of the first corrugated support rod 43, a second petal 723 that fits on the inner surface of the plurality of first connecting rods 45, and a third petal 725 that fits on the inner surface of the plurality of second connecting rods 46. The first petal 721, the second petal 723, and the third petal 725 can be an integrally formed structure. The petal body 72 is connected to the inner side of the connecting frame 40 by sewing, bonding, or hot pressing, so that the opposite ends of the petal body 72 are respectively connected to the intersection of the first annular support frame 30 and the connecting frame 40 and the intersection of the second annular support frame 50 and the connecting frame 40. Specifically, the edge of the second petal 723 away from the first petal 721 is connected to the intersection of the first annular support frame 30 and the connecting frame 40, and the edge of the third petal 725 away from the first petal 721 is connected to the intersection of the second annular support frame 50 and the connecting frame 40. The opposite sides of the flap 72 extend to the opposite sides of the connecting frame 40, that is, the opposite edges of the flap 72 overlap the opposite edges of the notch 401. A first corrugated support rod 43 is fixed to the flap 72 to increase support strength, prevent the connecting frame 40 from being deformed by venous pressure, and prevent the leaflets 74 from losing their one-way valve function.

[0061] In other embodiments, the first flap 721, the second flap 723 and the third flap 725 can be a split structure, and the first flap 721, the second flap 723 and the third flap 725 are respectively connected to the first corrugated support rod 43, the first connecting rod 45 and the second connecting rod 46 by sewing, bonding or hot pressing, and the first flap 721, the second flap 723 and the third flap 725 are integrated into a whole.

[0062] like Figure 4 and Figure 10 As shown, the leaflets 74 are connected to the inner surface of the valve body 72 (i.e., the side facing away from the connecting frame 40) by suturing, gluing, or heat pressing, thereby creating a one-way path for blood to flow through the venous valve prosthesis 100. In other words, the leaflets 74 act as a one-way valve. The leaflets 74 and the valve body 72 enclose a first region 75 and a second region 76. The first region 75 corresponds to a portion of the sinus region 403, and the second region 76 corresponds to another portion of the sinus region 403. The first region 75 and the second region 76 are located on opposite sides of the leaflets 74, and the leaflets 74 are positioned within the first region 75. One of the first region 75 and the second region 76 communicates with the first lumen 35 of the first annular support frame 30. In one embodiment, the first region 75 is the region where the leaflets 74 arch and communicate with the first lumen 35 of the first annular support frame 30, while the second region 76 is the region where the leaflets 74 arch and communicate with the third lumen 55 of the second annular support frame 50.

[0063] In other embodiments, the leaflets 74 and the body 72 may also be integrally formed.

[0064] In this embodiment, the valve assembly 70 further includes a covering disposed on the circumferential wall of the support body. The covering can be disposed on the inner or outer surface of the support body, and each covering is connected to the valve body 72. Specifically, the covering includes a first covering 77 disposed on the circumferential wall of the first annular support frame 30 and a second covering 78 disposed on the second annular support frame 50. The first covering 77 is sutured, bonded, or hot-pressed to the first annular support frame 30, and the side of the first covering 77 near the connecting frame 40 is connected to the valve body 72. The second covering 78 is sutured, bonded, or hot-pressed to the second annular support frame 50, and the side of the second covering 78 near the connecting frame 40 is connected to the valve body 72. Because the first annular support frame 30 is fixed to the first covering 77 and the second annular support frame 50 is fixed to the second covering 78, the support strength is increased, thereby enhancing the anchoring force of the first and second annular support frames 30, 50 after implantation in the venous vessel.

[0065] In other embodiments, the first covering 77, the petal body 72 and the second covering 78 are integrally formed; or the leaflet 74, the first covering 77, the petal body 72 and the second covering 78 are integrally formed.

[0066] The leaflet 74, the first covering 77, the valve body 72 and the second covering 78 are all made of polyester, polytetrafluoroethylene, polyurethane, medical silicone, dacron, biological valve, pericardium or other implantable medical materials.

[0067] like Figure 1 and Figure 2 As shown, the venous valve prosthesis 100 is implanted in an appropriate position of the inner cavity 301 of the venous blood vessel 300 through a conveying device, the first annular support frame 30 and the second annular support frame 50 are anchored to the inner wall of the venous blood vessel 300, and the connecting frame 40 presses against the inner wall of the venous blood vessel 300 and protrudes outward. The notch 401 can reduce the excessive expansion of the venous blood vessel 300 by the protruding part 41 of the connecting frame 40, and is conducive to better anchoring of the first annular support frame 30 and the second annular support frame 50 to the venous blood vessel 300, so that the venous valve prosthesis 100 is not easily displaced after being implanted in the venous blood vessel 300. Since the mesh holes 48 of the connecting skeleton 40 are larger than the mesh holes 37 of the first annular support skeleton 30 and the mesh holes 57 of the second annular support skeleton 50, and the connecting skeleton 40 is provided with a notch 401 in the circumferential direction, the venous valve prosthesis 100 as a whole has a certain degree of flexibility, the venous valve prosthesis 100 is easy to bend at the connecting skeleton 40, and the venous valve prosthesis 100 can more easily pass through the tortuous and complex blood vessels, reducing the risk of surgery. The blood in the inner cavity 301 of the venous blood vessel 300 flows from the proximal end to the distal end, that is, from the third inner cavity 55 of the second annular support skeleton 50 to the first inner cavity 35 of the first annular support skeleton 30. The blood flowing downstream impacts the leaflet 74 to move to the side away from the notch 401, and the leaflet 74 is separated from the inner wall of the venous blood vessel 300 to open a one-way passage of the venous valve prosthesis 100 (such as Figure 1 When the leaflet 74 is arched by the impact of the blood backflow in the vein 300 (as shown in FIG. Figure 2 As shown in FIG4 , the leaflets 74 are moved toward the notch 401 by the impact of blood backflow and abut against the inner wall of the vein 300 around the notch 401, that is, the area where eddy currents are formed in the first area 75, effectively avoiding blood backflow and preventing local thrombosis. When the blood in the vein 300 flows forward again, the leaflets 74 are pushed by the forward-flowing blood and move to the side away from the notch 401. Figure 4 , and the leaflet 74 squeezes out the blood in the first area 75, so that the blood in the first area 75 flows into the first inner cavity 35; therefore, based on the existence of the second area 76, when the backflow disappears, the one-way downstream passage can be quickly opened to increase the downstream blood flow.

[0068] In other embodiments, the venous valve prosthesis 100 is provided with a developing structure. Specifically, one of the first annular support frame 30, the connecting frame 40, and the second annular support frame 50 is provided with a developing structure, or two of the first annular support frame 30, the connecting frame 40, and the second annular support frame 50 are provided with a developing structure, or each of the first annular support frame 30, the connecting frame 40, and the second annular support frame 50 is provided with a developing structure. The developing structure is a developing wire or developing point that is continuously or discontinuously wound around the venous valve prosthesis 100, or the interventional venous valve stent 20 is made of an alloy doped with a developing material, for example, the nickel-titanium alloy wire is a nickel-titanium alloy wire containing tantalum.

[0069] Preferably, at least one of the first corrugated support rod 43, the second corrugated support rod 33 adjacent to the connection frame 40, and the third corrugated support rod adjacent to the connection frame 40 is surrounded by at least one ring of imaging threads or imaging points. During surgery, the position of the annular imaging structure can be clearly observed using imaging equipment, allowing for convenient and rapid insertion of the venous valve prosthesis 100 into the lumen 301 of the vein 300. Materials for the imaging element include, but are not limited to, gold, platinum, platinum-tungsten, palladium, platinum-iridium, rhodium, tantalum, or alloys or composites of these metals.

[0070] In other embodiments, the first coating 77 and / or the second coating 78 is provided with at least one circle of developing thread or developing point, and the developing thread or developing point is fixed on the first coating 77 and / or the second coating 78 by sewing, hot pressing or pasting.

[0071] See also Figure 11 The structure of the venous valve prosthesis 100a provided in the second embodiment of the present invention is similar to that of the first embodiment, except that the first and second coverings 77, 78 are omitted from the venous valve prosthesis 100 of the first embodiment. Specifically, the valve assembly 70 comprises only the valve body 72 disposed on the inner side of the connecting frame 40 and the leaflets 74 connected to the inner side of the valve body 72. The omission of the first and second coverings 77, 78 from the venous valve prosthesis 100a reduces manufacturing costs.

[0072] See also Figure 12 and Figure 13The structure of the venous valve prosthesis provided in the third embodiment of the present invention is similar to that of the first embodiment, except that the structure of the connecting frame 40a of the interventional venous valve stent 20a in the third embodiment differs from the structure of the connecting frame 40 of the interventional venous valve stent 20 in the first embodiment. Specifically, the connecting frame 40a includes a plurality of support rods 435. The plurality of support rods 435 extend axially along the first annular support frame 30 or the second support frame 50 and are arranged at intervals along the circumference of the first annular support frame 30 or the second support frame 50. A gap 401 is formed in the space between two adjacent support rods 435 along the circumference of the first annular support frame 30 or the second support frame 50. The gap 401 formed in the space between two adjacent support rods 435 with the largest spacing allows the valve leaflets 74 to pass through and abut against the venous vessel wall. The middle portion of at least one support rod 435 is bent outward to form a protrusion 41.

[0073] In this embodiment, each support rod 435 includes a central bending section 436, a proximal vertical section 437 located proximal to the central bending section 436, and a distal vertical section 438 located distal to the central bending section 436. The proximal vertical section 437 is connected to the first annular support frame 30 at one end distal to the central bending section 436, and the distal vertical section 438 is connected to the second annular support frame 50 at one end distal to the central bending section 436. The proximal vertical section 437 extends axially along the first annular support frame 30, and the distal vertical section 438 extends axially along the second annular support frame 50. The central portion of the central bending section 436 is bent outward, and the plurality of central bending sections 436 form a protrusion 41. The inner side of the protrusion 41 forms a sinus region 403, and the valve assembly 70 is disposed within the sinus region 403.

[0074] The proximal vertical sections 437 of several support rods 435 are respectively connected to the second trough 334 of the adjacent second corrugated support rod 33, and the distal vertical sections 438 are respectively connected to the third crest 532 of the adjacent third corrugated support rod 53; the area between the second trough 334 of the adjacent second corrugated support rod 33 and the third crest 532 of the third corrugated support rod 53 that is not connected by the support rod 435 forms a gap 401.

[0075] In this embodiment, there are six support rods 435, spaced apart within a 270-degree circumferential range of the interventional venous valve stent 20a. Within the area where the support rods 435 are arranged, the circumferential spacing between two adjacent support rods 435 is 45 degrees. In this case, the 90-degree intervals between the interventional venous valve stent 20a where the support rods 435 are not arranged form notches 401 for the leaflets 74 to pass through, i.e., the opening angle of the notches 401 is 90 degrees.

[0076] See also Figure 14 and Figure 15The structure of the venous valve prosthesis 100b provided in the fourth embodiment of the present invention is similar to that of the venous valve prosthesis 100 in the first embodiment, except that the venous valve prosthesis 100b in the fourth embodiment omits the second annular support frame 50 and the second covering 78 from the venous valve prosthesis 100 in the first embodiment. Specifically, the interventional venous valve stent comprises only the first annular support frame 30 and the connecting frame 40 connected to the end of the first annular support frame 30. The valve assembly 70 comprises only the valve body 72, the leaflets 74, and the first covering 77. The valve body 72 is sutured, bonded, or hot-pressed to the connecting frame 40, the leaflets 74 are sutured, bonded, or hot-pressed to the valve body 72, and the first covering 77 is sutured, bonded, or hot-pressed to the first annular support frame 30. The valve body 72 is connected to the first covering 77. The omission of the second annular support frame 50 and the second covering 78 in the venous valve prosthesis 100b reduces manufacturing costs. It should be understood that the first covering 77 can also be omitted in this embodiment.

[0077] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. An interventional venous valve stent capable of radial compression and expansion, characterized in that: include: A support body comprising a first annular support skeleton; as well as The connecting skeleton is a non-closed mesh bracket continuously arranged in the circumferential direction and connected to the end of the first annular support skeleton. The connecting skeleton is arranged along the circumference of the first annular support skeleton and is broken in the circumferential direction of the connecting skeleton to form a gap. The maximum opening angle of the gap in the circumferential direction of the connecting skeleton is between 90 degrees and 180 degrees. At least part of the connecting skeleton bulges outward to form a protrusion, and the inner side of the protrusion forms a sinus area; the connecting skeleton includes a first corrugated support rod, the first corrugated support rod extends along the circumference of the first annular support skeleton, the first corrugated support rod includes a plurality of first corrugated rods connected end to end, and the middle part of at least part of the first corrugated rod protrudes outward to form at least a part of the protrusion; the first corrugated support rod has a protrusion close to the first corrugated support rod. The first wave crest of the first annular support skeleton and the first wave trough away from the first annular support skeleton, the first wave crest and the first wave trough are formed between two adjacent first wave rods; the connecting skeleton includes a plurality of first connecting rods extending along the axial direction of the connecting skeleton, the first connecting rod is arranged between the first wave crest and the first annular support skeleton; the first connecting rod includes a first vertical section and a first curved section, the first vertical section extends along the axial direction of the first annular support skeleton, in the direction from one end of the first connecting rod close to the first annular support skeleton to the end away from the first annular support skeleton, the first curved section gradually bends outward to connect to the corresponding first wave crest, and the first curved section forms a part of the protrusion.

2. The interventional venous valve stent according to claim 1, characterized in that: There are multiple first corrugated support rods, and the multiple first corrugated support rods are arranged along the axial direction of the connecting skeleton.

3. The interventional venous valve stent according to claim 1, characterized in that: The connecting frame further includes a plurality of second connecting rods extending along the axial direction of the connecting frame, wherein the second connecting rods are connected to a first wave valley in the connecting frame away from the first annular supporting frame.

4. The interventional venous valve stent according to claim 1, characterized in that: A middle portion of each of the first wave rods protrudes outward to form a portion of the protruding portion.

5. The interventional venous valve stent according to claim 1, characterized in that: The first annular support skeleton includes a plurality of second corrugated support rods, which are arranged in axial sequence along the first annular support skeleton; the second corrugated support rods include a plurality of second wave peaks, a plurality of second wave valleys, and a second wave rod connecting two adjacent second wave peaks and second wave valleys, and the adjacent first wave peaks and second wave valleys are connected by the first connecting rod.

6. The interventional venous valve stent according to claim 5, characterized in that: Every two adjacent first connecting rods, the first corrugated support rods and the corresponding second corrugated support rods form a first grid hole, and every two adjacent second corrugated support rods form a plurality of second grid holes, and the aperture value of the first grid hole is greater than the aperture value of the second grid hole.

7. The interventional venous valve stent according to any one of claims 1 to 6, characterized in that: The supported body further includes a second annular support frame, the connecting frame is arranged between the first annular support frame and the second annular support frame, and the connecting frame is arranged along the circumference of the second annular support frame.

8. The interventional venous valve stent according to claim 7, characterized in that: The outer diameter of the protrusion is larger than the outer diameter of the first annular support frame and the outer diameter of the second annular support frame.

9. The interventional venous valve stent according to claim 7, characterized in that: 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.

10. The interventional venous valve stent according to claim 7, characterized in that: In a natural state, the two parts of the inner cavity of the venous valve stent divided by a reference plane are symmetrical about the reference plane, the normal direction of the reference plane is parallel to the axial direction of the first annular support skeleton, and the set of all points forming the maximum inner diameter of the connecting skeleton is located within the reference plane.

11. The interventional venous valve stent according to claim 1, characterized in that: The protrusion extends from one side of the connecting frame to the other opposite side along the circumference of the connecting frame.

12. A venous valve prosthesis for implantation in a venous vessel, characterized in that: The venous valve prosthesis includes an interventional venous valve stent and a valve assembly as described in any one of claims 1-11, wherein the valve assembly includes a leaflet connected to the inner side of the connecting skeleton, and the leaflet cover is arranged in at least a part of the sinus area and is used to construct a one-way passage in the vein.

13. The venous valve prosthesis according to claim 12, characterized in that The valve assembly also includes a valve body attached to the inner surface of the connecting frame, and the leaflets and the valve body enclose a first area and a second area, the first area corresponds to a part of the sinus area, and the second area corresponds to another part of the sinus area. The first area and the second area are located on opposite sides of the leaflet, and one of the first area and the second area is connected to the inner cavity of the first annular support frame, and the leaflet cover is arranged in the first area.

14. The venous valve prosthesis according to claim 13, characterized in that The valve assembly further includes a covering disposed on the peripheral wall of the support body, and each covering is connected to the valve body.

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