Deep vein stent

Abstract

The present invention belongs to the technical field of medical devices, and specifically relates to a deep vein stent. A deep vein stent includes a stent structure and an artificial valve leaflet; the stent structure includes: at least two valve supports, which are S-shaped structures, symmetrically arranged, forming a circle of convex artificial venous sinus area in the outflow section, and the valve support members pass through the artificial valve leaflet, supporting the artificial valve leaflet at the middle bend of the valve support members. The present invention adopts multiple valve supports with S-shaped structures, which can support the artificial valve leaflet, and can naturally form an artificial venous sinus area in the convex part near the outflow section. When applied to the vein, under the action of multiple valve supports, a circle of convex artificial venous sinus area can be formed on the vein, thereby achieving the same use effect as the actual venous valve, so that the artificial venous sinus area is formed at the position of the artificial valve leaflet.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a deep vein stent. Background Art

[0002] Many clinical conditions may require the placement of prosthetic implants to improve venous integrity or venous circulation. For example, conditions such as chronic venous insufficiency (CVI) or venous reflux can cause significant pain, itching, and swelling, which can lead to reduced patient activity and skin ulcers. These conditions can be caused by a number of underlying causes, including congenital weakness or absence of valves or venous walls, venous hypertension, and deep vein thrombosis.

[0003] Traditionally, these clinical conditions have been treated non-invasively, such as with anti-inflammatory or diuretic medications, compression garments, or other non-invasive therapies. Recently, invasive treatments, such as the placement of implants like venous valves, are being developed as a way to reverse these debilitating conditions. However, current venous stents require surgical intervention to open the blood vessels and are relatively invasive.

[0004] A compressible stent is proposed in a Chinese patented venous valve prosthesis (publication number: "CN106821547B"). However, the stent places the valve at the end, which poses a greater risk. When the vein further contracts due to pathology or other reasons, the artificial valve leaflets will fit tightly against the stent, causing complete blockage of the vein and affecting normal blood flow in the vein.

[0005] Therefore, novel intravenous stent structures are needed to compensate for these defects. Summary of the Invention

[0006] The present invention aims to provide a deep vein stent to address the technical problem that the existing venous implant stent structure is prone to cause vein blockage due to structural design problems, thereby affecting the normal blood circulation in the vein.

[0007] A deep vein stent, comprising a stent structure and an artificial valve leaflet;

[0008] The support structure comprises:

[0009] At least two valve support members are S-shaped and symmetrically arranged to form a convex artificial venous sinus area in the outflow section. The valve support member passes through the artificial valve leaflet and supports the artificial valve leaflet at the middle bend of the valve support member.

[0010] As a preferred solution, the artificial valve leaflet is a cone-like structure, with the side with a larger diameter located at the outflow end, the middle portion being fixed to the valve support, and the outer edge being free.

[0011] As a preferred solution, the support structure further includes:

[0012] A supporting base, an arc-shaped structure protruding toward the inflow end, is located between at least two of the valve support members, and the outflow end is respectively fixed to the inner wall of the middle bend of each valve support member. The supporting base is located on the outflow end side of the artificial valve leaflet and abuts against the artificial valve leaflet, causing the middle part of the artificial valve leaflet to protrude toward the inflow end.

[0013] As a preferred solution, an opening is provided in the middle of the artificial valve leaflet, and when the artificial valve leaflet is connected to the valve support and the support base respectively, the opening is blocked by the support base.

[0014] The artificial valve leaflet is connected to the valve support and the support base respectively by suturing.

[0015] As a preferred solution, the opening is a slit located in the middle of the artificial valve leaflet.

[0016] As a preferred embodiment, the artificial valve leaflet may comprise one or more synthetic materials, engineered biological tissues, biological valve leaflet tissues, pericardial tissues, cross-linked pericardial tissues, aortic root tissues, and chemically or biologically processed / treated tissues or a combination of one or more of the following.

[0017] As a preferred embodiment, the pericardial tissue is selected from but not limited to the group consisting of bovine, equine, porcine, ovine and human tissues or a combination thereof.

[0018] As a preferred solution, the support structure further includes two annular members, namely:

[0019] a first annular member connected to the outflow end of the valve support member;

[0020] a second annular member connected to the inflow end of the valve support member;

[0021] The valve support and the artificial valve leaflet are both located between the first annular member and the second annular member.

[0022] As a preferred solution, the annular member has at least one circle of diamond-shaped grids, and the diamond-shaped grids are composed of a plurality of diamond-shaped frames with diamond-shaped meshes.

[0023] As a preferred solution, the inner side surface of the top corner of the diamond frame is a U-shaped arc surface, and the frames between adjacent diamond frames are shared;

[0024] The top corners of two adjacent diamond-shaped frames are sequentially connected to form the diamond-shaped grid, and the two adjacent circles of the diamond-shaped grid are sequentially connected to form the ring member.

[0025] As a preferred solution, the outer side surface where the vertex located at the proximal end or the distal end is located is an arc surface convex toward the proximal end or the distal end.

[0026] As a preferred solution, at least one of the outflow end of the first annular member or the inflow end of the second annular member is provided with:

[0027] At least one connecting member is used to connect with an external conveyor.

[0028] As a preferred solution, the connecting piece is a circular sheet structure or a polygonal sheet structure.

[0029] As a preferred solution, at least one of the first annular member or the second annular member is provided with:

[0030] At least one barb, one end of the barb is fixed to the first annular member or the second annular member as a fixed end, and the other end of the barb is protruding outward as a free end and has an angle less than 90° with the axial direction of the support structure.

[0031] As a preferred solution, when only one of the first annular member or the second annular member is provided with the barb, the free end of the barb faces the inflow end;

[0032] When the first annular member or the second annular member is provided with the barbs, the free ends of the barbs on the first annular member are in opposite directions to the free ends of the barbs on the second annular member.

[0033] As a preferred solution, there are at least two barbs, and the at least two barbs are evenly arranged along the circumference of the first annular member or the second annular member;

[0034] The same annular member has at least one barb with its free end facing the inflow end and at least one barb with its free end facing the outflow end.

[0035] As a preferred solution, the free ends of adjacent barbs on the same annular member face in opposite directions;

[0036] When the number of the barbs is odd, it is allowed that the free ends of two adjacent barbs face the same direction.

[0037] As a preferred solution, when the number of the barbs on the same annular member is greater than four, the difference in number between the free ends of the barbs facing the inflow end and the free ends of the barbs facing the outflow end on the same annular member is less than two.

[0038] As a preferred solution, the diameter of the first annular member is greater than the diameter of the second annular member.

[0039] As a preferred solution, the radial supporting force of the first annular member is greater than the radial supporting force of the second annular member.

[0040] As a preferred solution, the frame side width of the diamond frame of the diamond grid of the first annular member is greater than the frame side width of the diamond frame of the diamond grid of the second annular member.

[0041] As a preferred solution, the number of diamond frames of the diamond grid of the first annular member is greater than the number of diamond frames of the diamond grid of the second annular member.

[0042] As a preferred solution, the number of diamond frames of the diamond grid of the first annular member is the number of diamond frames of the diamond grid of the second annular member plus XN, where X is a positive integer and N is the number of valve supports, where X is preferably 1, 2, or 3.

[0043] As a preferred solution, the middle parts of the different valve supports are directly connected.

[0044] As a preferred solution, the stent structure is a stent structure made by cutting a stainless steel tube, a nickel-titanium tube or a cobalt-chromium tube.

[0045] The positive progress of the present invention is that the present invention uses a deep vein stent, which has the following advantages:

[0046] 1. The multiple valve support members of the S-shaped structure support the artificial valve leaflets, while the convex portion near the outflow section naturally forms an artificial venous sinus area. When applied to a vein, the multiple valve support members create a convex artificial venous sinus area, achieving the same effect as an actual venous valve, forming an artificial venous sinus area at the location of the artificial valve leaflets.

[0047] 2. The artificial valve leaflet is a cone-shaped structure, and the outer edge is designed to be free and unfixed. This is because the blood pressure difference on both sides of the venous valve of the vein is small, so the outer edge of the artificial valve leaflet is in a free state and can also prevent blood from flowing back. Moreover, the outer edge of the artificial valve leaflet is free and can adapt to the diameter of veins of different people and different parts of the body, as well as the changes in the diameter of the patient's veins during the healing process. For example, when the blood vessel diameter is larger, the artificial valve leaflet will open wider when it is open, because the outer edge of the artificial valve leaflet itself is not restricted by the diameter of the stent structure. When the blood vessel diameter becomes smaller, the artificial valve leaflet will open smaller when it is open. When blood flows in from the inflow end, the position where the artificial valve leaflet is not connected to the valve support of the S-shaped structure will shrink, allowing blood to pass through the artificial valve leaflet. Moreover, because the artificial valve leaflet is located between the two annular parts and is fixed to the bend of the valve support part (that is, the S-shaped valve support part is inserted into the vein to form the position of the artificial venous sinus area), the outer edge is located relative to the outflow section. Therefore, after the artificial valve leaflet is opened, to a certain extent, the outer edge of the artificial valve leaflet will be located in a part of the artificial venous sinus area. The artificial venous sinus area bears part of the pressure of the artificial valve leaflet, which increases the ability of the artificial valve leaflet to tolerate pressure differences and prevents the artificial valve leaflet from flipping over due to excessive pressure differences.

[0048] 3. The design of the support base not only increases the strength between multiple valve support parts, but also makes the middle part of the artificial valve leaflet bulge toward the inflow end, increasing the streamline of the artificial valve leaflet and reducing the obstruction to blood flow.

[0049] 4. The middle part of the artificial valve leaflet is designed as an open structure, which can be a slit. This is to make it easier to form a convex structure in the middle part of the artificial valve leaflet toward the inflow end. The artificial valve leaflet is sutured with the valve support and the support base, and the opening on the artificial valve leaflet will be blocked by the support base, so it will not affect the artificial valve leaflet's function of preventing blood reflux. On the contrary, the convex structure formed by the artificial valve leaflet will first reduce the resistance of blood flowing downstream, and secondly, it will facilitate the retraction of the artificial valve leaflet, that is, the artificial valve leaflets on both sides of the valve support are more likely to move closer to the middle, which also reduces the resistance when the artificial valve leaflet is opened when blood flows downstream.

[0050] 5. The two ring members are used to support the present invention on the vein. In order to realize that the stent structure of the invention can be transported through a catheter, the first ring member and the second ring member are composed of a plurality of diamond frames with diamond meshes to form a circle of diamond grid or multiple circles of diamond grid.

[0051] 6. When the stent structure of the invention is delivered through a catheter, it can be delivered and implanted along the direction of blood flow or against the direction of blood flow, which is mainly determined based on the actual situation of the user. Therefore, at least one of the ends of the first annular member and the second annular member is provided with a connector for connecting to the delivery device.

[0052] 7. Design a barb structure on the annular member and design the position of the barb structure to ensure that the stent structure can work stably on the vein without migration.

[0053] 8. The diameter of the first annular member is slightly larger than that of the second annular member. This is because the deep veins are mainly the part where blood flows back to the heart. Generally, the closer the blood vessels are to the heart, the thicker their diameters are. Therefore, the diameter of the first annular member at the outflow section is larger than the diameter of the second annular member at the inflow end. This allows the stent structure to better fit the shape of the inner wall of the blood vessel and prevents the artificial valve leaflets from unexpectedly migrating away from the heart after being continuously subjected to venous pressure.

[0054] 9. Because the first annular member needs to cooperate with the valve support member to complete the establishment of the sinus area, the radial support force of the first annular member is slightly greater than the radial support force of the second annular member, which plays a role in assisting the establishment of the sinus area and makes the stent structure fit the inner wall of the blood vessel more closely.

[0055] 10. When the annular member of the stent structure needs to be delivered through a catheter by means of compression and constriction, the annular member is a diamond-shaped lattice annular member. The stent structure can be cut from a nickel-titanium tube in addition to the supporting base structure, and then the supporting base can be installed. Alternatively, the S-shaped valve support members on both sides can be bent inward to form a supporting base. When the stent structure of the present invention is artificially implanted through surgery, the annular member can be a diamond-shaped lattice annular member or a common annular member. The annular member of the stent structure does not need to be compressed and gripped. The stent structure can be cut from a stainless steel tube, nickel-titanium tube, or cobalt-chromium tube in addition to the supporting base structure, and then the supporting base can be installed. Alternatively, the S-shaped valve support members on both sides can be bent inward to form a supporting base. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] FIG1 (a) is a schematic structural diagram of an artificial valve leaflet of the present invention in an open state;

[0057] Figure 1(b) is a schematic diagram of Figure 1(a) from another angle;

[0058] Figure 1(c) is a front view of Figure 1(a);

[0059] FIG1( d ) is a schematic diagram of the structure of the artificial valve leaflet in FIG1( a ) when it is in a folded state;

[0060] Figure 1(e) is a schematic diagram of the structure of Figure 1(a) excluding the artificial valve leaflet;

[0061] FIG2( a ) is another schematic diagram of the structure of the artificial valve leaflet of the present invention when it is in an open state;

[0062] Figure 2 (b) is a schematic diagram of Figure 2 (a) from another angle;

[0063] Figure 2 (c) is a front view of Figure 2 (a);

[0064] FIG3 (a) is a schematic diagram of a structure in which barbs are provided on FIG2 (a);

[0065] Figure 3(b) is a partial enlarged view of point A in Figure 3(a);

[0066] Figure 3 (c) is a partial enlarged view of point B in Figure 3 (a);

[0067] FIG4 (a) is a schematic structural diagram of a bracket structure of the present invention;

[0068] FIG4 (b) is a schematic structural diagram of another bracket structure of the present invention;

[0069] Figure 5 A schematic structural diagram of an artificial valve leaflet of the present invention;

[0070] Figure 6 A schematic diagram of an application of the present invention when the artificial valve leaflet is in an open state when applied to a vein;

[0071] Figure 7 This is a schematic diagram of the application of the present invention when the artificial valve leaflet is in a retracted state when applied to a vein. DETAILED DESCRIPTION

[0072] In order to make the technical means, creative features, objectives and effects achieved by the present invention easier to understand, the present invention is further described below with reference to specific illustrations.

[0073] In the present invention, when describing a deep vein stent, "inflow end" refers to the normal direction in which blood flows, and after the deep vein stent is implanted, blood flows into one end of the deep vein stent; accordingly, "outflow end" refers to the normal direction in which blood flows, and after the deep vein stent is implanted, blood flows out of one end of the deep vein stent.

[0074] In the present invention, when describing a deep vein stent, "axial direction" refers to the direction between the "inflow end" and the "outflow end".

[0075] Referring to Figures 1(a) to 3(c), a deep vein stent comprises a stent structure 100 and an artificial valve leaflet 200. The stent structure 100 includes at least two valve supports 110. Each valve support 110 is S-shaped. Multiple valve supports 110 are symmetrically arranged, forming a convex artificial venous sinus region in the outflow section. The valve supports 110 extend through the artificial valve leaflet 200, supporting the artificial valve leaflet 200 at the central bend of the valve supports 110. For example, when there are two valve supports 110, the two valve supports 110 are axially symmetrically arranged. When there are three or more valve supports 110, the multiple valve supports 110 are symmetrically arranged along a circumferentially uniform circle. The distance between the multiple valve supports 110 and the size of the circle can be determined based on the size of the artificial valve leaflet 200, with the goal of supporting the artificial valve leaflet 200 at the central bend.

[0076] The present invention adopts multiple S-shaped valve support members 110 to support the artificial valve leaflet 200, and the artificial venous sinus area can be naturally formed at the convex part near the outflow section. Figure 6 and Figure 7 As shown, a circle of convex artificial venous sinus area 500 can be formed on the vein, thereby achieving the same use effect as an actual venous valve, so that the artificial venous sinus area 500 is formed at the position of the artificial valve leaflet.

[0077] In some embodiments, the artificial valve leaflet 200 is a conical structure, with the larger diameter side of the artificial valve leaflet 200 located at the outflow end, that is, the opening of the artificial valve leaflet 200 faces the outflow end. The middle portion of the artificial valve leaflet 200 is fixed to the valve support 110, and the outer edge of the artificial valve leaflet 200 is free.

[0078] The artificial valve leaflet 200 of the present invention has an umbrella-shaped or bowl-shaped conical structure, and the outer edge is designed to be free and unfixed. This is because the blood pressure difference on both sides of the venous valve is small, so the outer edge of the artificial valve leaflet 200 is free and can also achieve the function of preventing blood backflow. Moreover, the outer edge of the artificial valve leaflet 200 is free, which can adapt to different people, different parts of the venous vessels with different diameters, and changes in the diameter of the venous vessels of patients during the healing process. For example: Figure 6 and Figure 7 , the direction of the arrow is the direction of blood flow. When the diameter of the blood vessel is large, such as Figure 6 As shown in FIG, the artificial valve leaflet 200 opens wider when in the open state because the outer edge of the artificial valve leaflet 200 itself is not restricted by the diameter of the stent structure. When the diameter of the blood vessel becomes smaller, the artificial valve leaflet 200 opens smaller when in the open state. When blood flows in from the inflow end, as shown in FIG. Figure 7As shown in FIG, the position where the artificial valve leaflet 200 is not connected to the valve support member of the S-shaped structure will be folded, allowing blood to pass through the artificial valve leaflet 200. At the position of the artificial venous sinus area 500, the outer edge is located relative to the outflow section, so after the artificial valve leaflet 200 is opened, as shown in FIG. Figure 6 As shown in the figure, to a certain extent, the outer edge of the artificial valve leaflet 200 will be located in a part of the artificial venous sinus area 500. The artificial venous sinus area 500 bears part of the pressure of the artificial valve leaflet 200, which increases the ability of the artificial valve leaflet 200 to tolerate pressure differences and prevents the artificial valve leaflet 200 from flipping over due to excessive pressure differences.

[0079] In some embodiments, referring to FIG4( a ), the stent structure 100 further includes a support base 120 . The support base 120 is an arc-shaped structure that bulges toward the inflow end. The support base 120 is located between at least two valve support members 110 . The outflow end of the support base 120 is fixed to the inner wall of the middle bend of each valve support member 110 . The support base 120 is located on the outflow side of the artificial valve leaflet 200 and abuts against the artificial valve leaflet 200, causing the middle portion of the artificial valve leaflet 200 to bulge toward the inflow end. The support base 120 not only increases the strength between the multiple valve support members, but also causes the middle portion of the artificial valve leaflet to bulge toward the inflow end, thereby increasing the streamlined shape of the artificial valve leaflet and reducing obstruction to blood flow.

[0080] In some embodiments, reference Figure 5 An opening 210 is provided in the middle of the artificial valve leaflet 200 . When the artificial valve leaflet 200 is connected to the valve support 110 and the support base 120 respectively, the opening 210 is blocked by the support base 120 .

[0081] In some embodiments, the opening 210 is a slit located in the middle of the artificial valve leaflet 200 .

[0082] In some embodiments, the artificial valve leaflet 200 is connected to the valve support 110 and the support base 120 respectively by suturing.

[0083] The middle part of the artificial valve leaflet 200 is designed to be an open structure, which can be a slit. This is to make it easier to form a convex structure toward the inflow end in the middle part of the artificial valve leaflet 200. The artificial valve leaflet 200 is connected to the valve support 110 and the support base 120, and the opening 210 on the artificial valve leaflet 200 will be blocked by the support base 120, so it will not affect the function of the artificial valve leaflet 200 to prevent blood backflow. On the contrary, the convex structure formed by the artificial valve leaflet 200 will first reduce the resistance of blood flowing downstream, and secondly, it will facilitate the retraction of the artificial valve leaflet 200, that is, the artificial valve leaflets 200 on both sides of the valve support 110 are more likely to move closer to the middle, which also reduces the resistance when the artificial valve leaflet 200 is opened when blood flows downstream.

[0084] In some embodiments, the artificial valve leaflet 200 may comprise a combination of one or more synthetic materials, engineered biological tissue, biological valve leaflet tissue, pericardial tissue, cross-linked pericardial tissue, aortic root tissue, or chemically or biologically processed / treated tissue.

[0085] In some embodiments, the pericardial tissue is selected from, but not limited to, the group consisting of bovine, equine, porcine, ovine, and human tissue, or a combination thereof.

[0086] In some embodiments, the stent structure 100 further includes two annular members, namely a first annular member 130 and a second annular member 140. The first annular member 130 is connected to the outflow end of the valve support member 110, and the second annular member 140 is connected to the inflow end of the valve support member 110. The valve support member 110 and the artificial valve leaflet 200 are both located between the first annular member 130 and the second annular member 140. That is, the stent structure 100 includes a first annular member 130, a plurality of valve support members 110, and a second annular member 140 connected in sequence from the outflow end to the inflow end. When the stent structure 100 has a support base 120, the support base 120 is fixed between the inner walls of the plurality of valve support members 110.

[0087] In some embodiments, the valve support 110 of the present invention is an S-shaped structure, which has three bends, namely the outflow end bend, the middle bend and the inflow end bend. The outflow end portion of the outflow end bend is connected to the inflow end face of the first annular member 130, and the inflow end portion of the inflow end bend is connected to the outflow end face of the second annular member 140. The middle bend is bent inward, and the multiple valve support members 110 form a circle of inwardly bent accommodating cavity, the middle of the artificial valve leaflet 200 is located inside the accommodating cavity and is fixedly connected to the valve support member 110, and the free end of the artificial valve leaflet 200 extends outward from the accommodating cavity to the outside of the accommodating cavity. When the stent structure 100 has a supporting base 120, the supporting base 120 is located inside the accommodating cavity.

[0088] In some embodiments, referring to Figures 1(a) to 1(d), the annular member of the present invention may be an ordinary annular member, and referring to Figures 2(a) to 3(a), the annular member of the present invention may also be an annular member having at least one circle of diamond grids, and the diamond grids are composed of a plurality of diamond frames 150 having diamond meshes.

[0089] In some embodiments, referring to FIG. 3 ( b ) and FIG. 3 ( c ), the inner side surface of the top corner of the diamond frame 150 is a U-shaped arc surface 151 , and the frame is shared by adjacent diamond frames 150 .

[0090] In some embodiments, the top corners of two adjacent diamond-shaped frames 150 are sequentially connected to form a diamond-shaped grid, and two adjacent circles of diamond-shaped grids are sequentially connected to form a ring.

[0091] In some embodiments, the outer side surface where the vertex at the proximal end or the distal end is located is an arc surface 152 that bulges toward the proximal end or the distal end.

[0092] In some embodiments, at least one connector 300 is provided on the outflow end of the first annular member 130 or the inflow end of the second annular member 140. The connector 300 is used to connect to an external delivery device. When delivered via a catheter, the stent structure 100 can be delivered and implanted along or against the direction of blood flow, depending on the user's actual needs. Therefore, at least one of the ends of the first annular member 130 and the second annular member 140 is provided with a connector 300 for connection to an external delivery device. Alternatively, both the first annular member 130 and the second annular member 140 may be provided with a connector 300.

[0093] The number of connectors 300 can be determined based on the diameter of the first annular member 130 or the second annular member 140. As shown in Figure 2(a), two connectors 300 are provided on each of the first annular member 130 and the second annular member 140, and the two connectors 300 are evenly spaced along the circumference. The connectors 300 on the first annular member 130 and the second annular member 140 are radially symmetrical.

[0094] In some embodiments, the connecting member 300 is a circular sheet structure or a polygonal sheet structure. When the connecting member 300 is connected to the annular member, it can be connected integrally through a connecting rod, or it can be directly connected integrally with the annular member. The connecting member 300 and the annular member can be made integrally.

[0095] In some embodiments, referring to Figures 3(a) to 3(c), at least one of the first annular member 130 or the second annular member 140 is provided with at least one barb 400, one end of the barb 400 is fixed to the first annular member 130 or the second annular member 140 as a fixed end, and the other end of the barb 400 protrudes outward as a free end and has an angle of less than 90° with the axial direction of the support structure 100.

[0096] In some embodiments, when only one of the first annular member 130 or the second annular member 140 is provided with barbs 400, the free ends of the barbs 400 face the inflow end. When both the first annular member 130 or the second annular member 140 are provided with barbs 400, the free ends of the barbs 400 on the first annular member 130 and the free ends of the barbs 400 on the second annular member 140 face opposite directions. That is, as shown in Figures 3(a) to 3(c), the free ends of the barbs 400 on the first annular member 130 face the inflow end, while the free ends of the barbs 400 on the second annular member 140 face the outflow end, or vice versa.

[0097] In some embodiments, there are at least two barbs 400, and at least two barbs 400 are evenly arranged along the circumference of the first annular member 130 or the second annular member 140; the same annular member has at least one barb 400 with its free end facing the inflow end and at least one barb 400 with its free end facing the outflow end.

[0098] In some embodiments, the free ends of adjacent barbs 400 on the same annular member face in opposite directions. When the number of barbs 400 is odd, only two adjacent barbs 400 may face in the same direction. When the number of barbs 400 is even, the free ends of adjacent barbs 400 may face in opposite directions.

[0099] In some embodiments, when there are more than four barbs 400 on the same annular member, the difference in number between the free ends of the barbs 400 facing the inflow end and the free ends of the barbs 400 facing the outflow end on the same annular member is less than two.

[0100] In some embodiments, when the annular member adopts a diamond-shaped grid composed of a plurality of diamond-shaped frames 150 , the barbs 400 are arranged between two adjacent diamond-shaped frames 150 .

[0101] The present invention designs the barb structure on the annular member and designs the position of the barb structure, so that the stent structure 100 can work stably on the vein without migration.

[0102] In some embodiments, the diameter of the first annular member 130 is larger than the diameter of the second annular member 140. The diameter of the first annular member 130 is slightly larger than the diameter of the second annular member 140 because deep veins are generally the part where blood flows back to the heart, and the blood vessels are generally thicker the closer they are to the heart. Therefore, the diameter of the first annular member 130 at the outflow end is larger than the diameter of the second annular member 140 at the inflow end. This allows the stent structure 100 to better conform to the shape of the inner wall of the blood vessel and prevents the artificial valve leaflets 200 from unintentionally migrating away from the heart after being continuously subjected to venous pressure.

[0103] In some embodiments, because the first annular member 130 needs to cooperate with the valve support member 110 to complete the establishment of the sinus area, the radial support force of the first annular member 130 is slightly greater than the radial support force of the second annular member 140, which plays a role in assisting the establishment of the sinus area and at the same time makes the stent structure 100 fit more closely to the inner wall of the blood vessel.

[0104] In some embodiments, in order to adjust the radial support force of the first ring member 130 to be slightly larger than the radial support force of the second ring member 140, the frame edge width of the diamond frame 150 of the diamond grid of the first ring member 130 is larger than the frame edge width of the diamond frame 150 of the diamond grid of the second ring member 140. By increasing the width of the edge of the diamond frame 150, its support performance is increased, and the radial support force of the first ring member 130 is increased.

[0105] In some embodiments, in order to adjust the radial support force of the first annular member 130 to be slightly greater than the radial support force of the second annular member 140, the number of diamond frames 150 of the diamond grid of the first annular member 130 is greater than the number of diamond frames 150 of the diamond grid of the second annular member 140. By increasing the number of diamond frames 150 of the first annular member 130, the density of the diamond frames 150 of the first annular member 130 is greater than the density of the diamond frames 150 of the second annular member 140, thereby increasing the density of the first annular member 130. Regarding radial support force, it is generally preferred that the number of diamond frames 150 of the diamond grid of the first annular member 130 is the number of diamond frames 150 of the diamond grid of the second annular member 140 plus XN, where X is a positive integer and N is the number of valve support members, and X is preferably 1, 2, or 3, because adding too many diamond frames 150 to the first annular member 130 will affect its compression performance. However, it should be noted that the number X is not limited to 1, 2, or 3, but can be adjusted according to the actual situation of the stent structure 100.

[0106] In some embodiments, the stent structure 100 is a stent structure 100 made by cutting a stainless steel tube, a nickel titanium tube, or a cobalt chromium tube.

[0107] In specific applications, when the annular member of the stent structure 100 needs to be delivered through a catheter by means of compression and tightening, the annular member of the present invention is an annular member of a diamond lattice. The stent structure 100 can be cut from a nickel-titanium tube in addition to the support base 120, and then the support base 120 is installed. When the stent structure 100 of the present invention is artificially implanted through surgery, the annular member of the stent structure 100 does not need to be compressed and gripped. The annular member of the present invention can be an annular member of a diamond lattice or an ordinary annular member. The stent structure 100 can be cut from a stainless steel tube, a nickel-titanium tube or a cobalt-chromium tube in addition to the support base 120, and then the support base is installed. It should be noted here that simple material replacement also falls within the scope of protection of the present invention.

[0108] In some embodiments, as shown in FIG4 (b), in order for the stent structure 100 to be cut from a piece of tubing, while the stent structure 100 can retain the function of the support base 120 connecting the valve support member 110, the middle parts of different valve support members 110 are directly connected to each other, which can be welding, adhesion, etc. Since the artificial valve leaflet 200 is elastic and is connected to the stent structure 100 by suturing, although the direct connection of the middle part of the valve support member 110 is not as good as adding a support base 120 to form a smooth transition surface, the elasticity of the artificial valve leaflet 200 and the suture line can still be used to achieve the combination of the artificial valve leaflet 200 and the stent structure 100, and to prevent blood leakage from occurring in the middle part of the artificial valve leaflet 200.

[0109] The basic principles, main features, and advantages of the present invention are shown and described above. Those skilled in the art should understand that the present invention is not limited to the foregoing embodiments. The foregoing embodiments and descriptions are merely illustrative of the principles of the present invention. Various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention. Such changes and modifications are intended to fall within the scope of the present invention. The scope of protection claimed in the present invention is defined by the appended claims and their equivalents.

Claims

1. A deep vein stent, comprising a stent structure and an artificial valve leaflet; It is characterized in that The support structure comprises: At least two valve supports are S-shaped and symmetrically arranged to form a convex artificial venous sinus area at the outflow end. The valve supports penetrate the artificial valve leaflets and support the artificial valve leaflets at the middle bend of the valve supports; A support base, an arc-shaped structure protruding toward the inflow end, is located between at least two of the valve support members, and the outflow end is fixed to the inner wall of the middle bend of each valve support member. The support base is located on the outflow end side of the artificial valve leaflet and abuts against the artificial valve leaflet, causing the middle part of the artificial valve leaflet to protrude toward the inflow end; Two annular members, namely: a first annular member connected to the outflow end of the valve support member; a second annular member connected to the inflow end of the valve support member; the valve support member and the artificial valve leaflet are both located between the first annular member and the second annular member; At least one of the first annular member or the second annular member is provided with: At least one barb, one end of the barb is fixed to the first annular member or the second annular member as a fixed end, and the other end of the barb is protruding outward as a free end and has an angle less than 90° with the axial direction of the support structure.

2. The deep vein stent according to claim 1, characterized in that: The artificial valve leaflet is a cone-like structure, with the side with a larger diameter located at the outflow end, the middle part being fixed to the valve support, and the outer edge being in a free state.

3. The deep vein stent according to claim 1, characterized in that: An opening is provided in the middle of the artificial valve leaflet. When the artificial valve leaflet is connected to the valve support and the support base respectively, the opening is blocked by the support base.

4. The deep vein stent according to claim 3, characterized in that: The artificial valve leaflet is connected to the valve support and the support base respectively by suturing.

5. The deep vein stent according to claim 3, characterized in that: The opening is a slit located in the middle of the artificial valve leaflet.

6. The deep vein stent according to claim 1, characterized in that: The artificial valve leaflet comprises one or more synthetic materials, engineered biological tissues, biological valve leaflet tissues, pericardial tissues, aortic root tissues, and chemically or biologically processed / treated tissues or a combination thereof.

7. The deep vein stent according to claim 6, characterized in that: The pericardial tissue is selected from, but not limited to, the group consisting of bovine, equine, porcine, ovine, and human tissues, or a combination thereof.

8. The deep vein stent according to claim 1, characterized in that: The annular member has at least one circle of diamond-shaped grids, and the diamond-shaped grids are composed of a plurality of diamond-shaped frames with diamond-shaped meshes.

9. The deep vein stent according to claim 8, characterized in that: The inner side surface of the top corner of the diamond frame is a U-shaped arc surface, and the frames of adjacent diamond frames are shared; The top corners of two adjacent diamond-shaped frames are sequentially connected to form the diamond-shaped grid, and two adjacent circles of the diamond-shaped grid are sequentially connected to form the ring member.

10. The deep vein stent according to claim 9, characterized in that: The outer side surface where the vertex located at the proximal end or the distal end is located is an arc surface convex toward the proximal end or the distal end.

11. The deep vein stent according to claim 1, characterized in that: At least one of the outflow end of the first annular member or the inflow end of the second annular member is provided with: At least one connecting member.

12. The deep vein stent according to claim 11, characterized in that: The connecting piece is a circular sheet structure or a polygonal sheet structure.

13. The deep vein stent according to claim 1, characterized in that: When only one of the first annular member or the second annular member is provided with the barb, the free end of the barb faces the inflow end; When the first annular member or the second annular member is provided with the barbs, the free ends of the barbs on the first annular member are in opposite directions to the free ends of the barbs on the second annular member.

14. The deep vein stent according to claim 1, characterized in that: There are at least two barbs, and the at least two barbs are evenly arranged along the circumference of the first annular member or the second annular member; The same annular member has at least one barb with its free end facing the inflow end and at least one barb with its free end facing the outflow end.

15. The deep vein stent according to claim 14, characterized in that: The free ends of the adjacent barbs on the same annular member face in opposite directions; When the number of the barbs is odd, it is allowed that the free ends of two adjacent barbs face the same direction.

16. The deep vein stent according to claim 14, characterized in that: When the number of the barbs on the same annular member is greater than four, the difference in number between the free ends of the barbs facing the inflow end and the free ends of the barbs facing the outflow end on the same annular member is less than two.

17. The deep vein stent according to claim 1, characterized in that: The diameter of the first annular member is greater than the diameter of the second annular member.

18. The deep vein stent according to claim 1, characterized in that: The radial supporting force of the first annular member is greater than the radial supporting force of the second annular member.

19. The deep vein stent according to claim 8, characterized in that: The frame side width of the diamond frame of the diamond grid of the first annular member is greater than the frame side width of the diamond frame of the diamond grid of the second annular member.

20. The deep vein stent according to claim 8, characterized in that: The number of diamond frames of the diamond grid of the first annular member is greater than the number of diamond frames of the diamond grid of the second annular member.

21. The deep vein stent according to claim 20, characterized in that: The number of diamond frames of the diamond lattice of the first annular member is the number of diamond frames of the diamond lattice of the second annular member plus XN, where X is a positive integer and N is the number of valve support members.

22. The deep vein stent according to claim 1, characterized in that: The middle parts of the different valve supports are directly connected.

23. The deep vein stent according to claim 1, characterized in that: The support structure is a support structure made by cutting a stainless steel tube, a nickel titanium tube or a cobalt chromium tube.

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