Iliac vein stent and system thereof

Abstract

The invention provides an iliac vein stent and a system thereof, the iliac vein stent comprises a main body stent, an embedded branch and a second branch, the main body stent comprises a main body part and a first branch connected to the far end of the main body part; the embedded branch is arranged in the main body part after being folded and shaped, and part of the outer wall of the embedded branch is fixedly connected with the inner wall of the main body bracket; compared with a natural state, the minimum distance between the embedded branch and the center of the main body part in the folded shaping state is increased; and the second branch is embedded into the embedded branch and is connected with the main body bracket. According to the iliac vein stent and the iliac vein stent system, due to the fact that the embedded branch is arranged in the main body part after being folded and shaped, the elastic restoring force of the embedded branch in the folded and shaped state is small and even can be ignored, and when the compressed iliac vein stent is located in the sheath tube, the extrusion force and friction force between the embedded branch and the inner sheath core become small; and the damage of the inner sheath core to the embedded branch is effectively reduced.

Description

Technical Field

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

[0002] The current common treatment method for cardiovascular diseases is to use catheter technology to intervene. Specifically, it refers to the use of catheter interventional treatment methods to place various materials and instruments into the heart, arteries, veins and other parts of the human body to treat cardiovascular diseases.

[0003] For example, the iliac vein is an important blood vessel for blood to flow back to the heart from the lower limbs and pelvis. Due to its specific anatomical structure, it is easily compressed, which can lead to blood flow obstruction and other complications. The iliac compression segment vein, as the compressed part of the iliac vein, is at risk of local lumen stenosis and requires interventional surgery.

[0004] See also Figure 1 As shown, the existing iliac artery bifurcation stent group generally includes a main stent 1 and an embedded stent 2. During the installation process, the inner sheath core 3 passes through the main stent 1, and the outer periphery of the inner sheath core 3 will contact the embedded stent 2. Then the iliac artery bifurcation stent group is compressed as a whole in the sheath tube. During the compression process, since the embedded stent 2 is composed of elastic metal nickel-titanium wire, the elastic metal nickel-titanium wire of the embedded stent 2 is in a compressed stress state, the inner sheath core 3 will contact the embedded stent 2 and squeeze each other to generate a large squeezing force. When the iliac artery bifurcation stent group in a compressed state moves in the sheath tube, there will be mutual squeezing and friction between the embedded stent 2 and the inner sheath core 3, causing the embedded stent 2 to be damaged. Summary of the invention

[0005] In view of the above-mentioned shortcomings, the present invention provides an iliac vein stent and its system. The iliac vein stent comprises: a main stent, comprising a main body and a first branch connected to the distal end of the main body; an embedded branch, the embedded branch is arranged in the main body after being folded and shaped, and a part of the outer wall of the embedded branch is fixedly connected to the inner wall of the main stent; compared with the natural state, the minimum distance between the embedded branch and the center of the main body is larger in the folded and shaped state; and a second branch, the second branch can be embedded in the embedded branch and connected to the main stent.

[0006] Furthermore, in a natural state, the cross-section of the embedded branch is circular; in a folded and shaped state, at least part of the inner walls of the embedded branch are close to each other so that the cross-section of the embedded branch is non-circular.

[0007] Furthermore, in the folded and shaped state, the embedded branches are bent and folded to form a bow shape.

[0008] Furthermore, in the folded and shaped state, the two free ends of the arched embedded branches are further bent toward each other to form a C shape.

[0009] Furthermore, the embedded branch includes a mesh reinforcement layer and a coating layer, and the mesh reinforcement layer is arranged on the coating layer.

[0010] Furthermore, the mesh reinforcement layer includes a plurality of first-direction reinforcement wires and a plurality of second-direction reinforcement wires, the first-direction reinforcement wires and the second-direction reinforcement wires overlap with each other to form the mesh reinforcement layer, and the coating layer covers one side or both sides of the mesh reinforcement layer.

[0011] Furthermore, the mesh reinforcement layer and the coating layer are made of one or more of polylactic acid, polycaprolactone and polycarbonate.

[0012] The present invention also relates to an iliac vein stent system, comprising the above-mentioned iliac vein stent and a conveyor, wherein the conveyor comprises: a handle; a sheath tube, the proximal side of the sheath tube being connected to the handle; an inner sheath core, slidably inserted into the sheath tube and the proximal side of the inner sheath core being connected to the handle; an outer sheath core, sleeved outside the inner sheath core and located in the sheath tube, the proximal side of the outer sheath core being fixedly connected to the handle; the iliac vein stent is sleeved on the inner sheath core and located in the sheath tube, and an expansion device is provided in the embedded branch, and the expansion device can expand the embedded branch from a folded and shaped state to a natural state.

[0013] Furthermore, it also includes a connecting tube, a through channel is provided on the tube wall of the outer sheath core, the through channel extends axially from the proximal side of the outer sheath core to the distal end face of the outer sheath core, the distal end of the connecting tube passes through the through channel and is connected with the expansion device, and the proximal end of the connecting tube extends from the through channel and is connected with the outside of the handle.

[0014] Furthermore, a pipe joint is movably connected to the handle, and the proximal end side of the connecting pipe is fixedly connected to the pipe joint and communicated with each other.

[0015] The iliac vein stent and system provided by the embodiments of the present invention have embedded branches that are arranged in the main body after being folded and shaped. The elastic restoring force of the embedded branches in the folded and shaped state is small or even negligible. When the compressed iliac vein stent moves in the sheath or when the iliac vein stent is located in the sheath, the extrusion force and friction force generated by the mutual extrusion between the embedded branches and the inner sheath core can be as small as possible, thereby effectively reducing the damage to the embedded branches or the inner sheath core during the process of the iliac vein stent being put into or taken out of the sheath.

[0016] It should be understood that the above general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure of the embodiments of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying any creative work.

[0018] Figure 1 It is a schematic diagram of an iliac artery bifurcation stent set in the background technology;

[0019] Figure 2 is a schematic diagram of the structure of an iliac vein stent provided by an embodiment of the present invention;

[0020] Figure 3 This is a diagram showing an embedded branch in a folded and shaped state provided by an embodiment of the present invention;

[0021] FIG4(A) is a schematic diagram of the structure of an embedded branch in a natural state provided by an embodiment of the present invention;

[0022] FIG4(B) is a schematic diagram of the structure of an iliac vein stent with embedded branches in a natural state provided by an embodiment of the present invention;

[0023] Figure 5 is a partial structural schematic diagram of an iliac vein stent system provided by an embodiment of the present invention, wherein an inner sheath core, a sheath tube and an embedded branch are shown;

[0024] Figure 6 It is another folding and shaping state diagram of the embedded branch provided by an embodiment of the present invention;

[0025] Figure 7 It is a schematic diagram of the installation of the embedded branch in the sheath tube when it is folded and shaped according to an embodiment of the present invention;

[0026] Figure 8 is a structural schematic diagram of a first shaping mold provided by an embodiment of the present invention;

[0027] Fig. 9 is a partial structural schematic diagram of a first shaping mold provided by an embodiment of the present invention;

[0028] Fig.10 is a structural schematic diagram of a second shaping mold provided by an embodiment of the present invention;

[0029] Fig.11 is a partial structural schematic diagram of a second shaping mold provided by an embodiment of the present invention;

[0030] Fig.12is a schematic diagram of the overall structure of an embedded branch provided by an embodiment of the present invention;

[0031] Fig.13 is a schematic diagram of a multi-layer structure of embedded branches provided by an embodiment of the present invention;

[0032] Fig.14 It is a schematic diagram of manufacturing an embedded branch provided by an embodiment of the present invention;

[0033] Fig.15 is a schematic diagram of manufacturing another embedded branch provided by an embodiment of the present invention;

[0034] Fig.16 is a schematic structural diagram of an iliac vein stent system provided by an embodiment of the present invention;

[0035] Fig.17 It is a partial structural schematic diagram of an iliac vein stent system provided by an embodiment of the present invention;

[0036] Fig.18 is a cross-sectional view of an outer sheath tube provided by an embodiment of the present invention;

[0037] Fig.19 is a partial structural schematic diagram of an iliac vein stent system provided by an embodiment of the present invention, wherein the expansion device is close to the through channel;

[0038] Fig. 20 is a schematic structural diagram of an iliac vein stent system provided by an embodiment of the present invention;

[0039] Description of reference numerals:

[0040] 100. Iliac vein stent;

[0041] 10. Main frame; 11. Main body; 111. First opening; 112. Second opening; 12. First branch;

[0042] 20. Embedded branch; 21. Mesh reinforcement layer; 211. First direction reinforcement wire; 212. Second direction reinforcement wire; 22. Covering layer; 23. First middle layer; 24. Second middle layer; 25. Internal channel;

[0043] 30. Second branch;

[0044] 200, conveyor; 201, inner sheath core; 202, sheath tube; 203, handle; 204, outer sheath core; 2041, through channel; 2042, sheath core channel;

[0045] 300, expansion device; 400, connecting pipe; 500, pipe joint;

[0046] 1000a, first shaping mold; 1001, first pressing tool; 1002, first placing tool; 1000b, second shaping mold; 1003, second pressing tool; 1004, second placing tool;

[0047] 2001, spinneret; 2002, rotating receiving circular shaft; 3001, tooling; 3002, coating liquid. DETAILED DESCRIPTION

[0048] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0049] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "multiple" is two or more, unless otherwise clearly and specifically defined.

[0050] It should also be understood that the terms used in the present specification are only for the purpose of describing specific embodiments and are not intended to limit the present invention. As used in the present specification and the appended claims, the singular forms "a", "an" and "the" are intended to include plural forms unless the context clearly indicates otherwise.

[0051] It should be further understood that the term "and / or" used in the present description and the appended claims refers to any and all possible combinations of one or more of the associated listed items, and includes these combinations.

[0052] Some embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the absence of conflict, the following embodiments and features in the embodiments can be combined with each other.

[0053] For ease of description, the terms "proximal" and "distal" are defined here as commonly used terms in the field of interventional medicine. The "distal" refers to the end away from the operator during the operation, and the "proximal" refers to the end close to the operator during the operation. The axial direction of the occluding body or iliac vein stent refers to the direction parallel to the line connecting the distal center and the proximal center of the interventional medical device; the radial direction of the occluding body or iliac vein stent refers to the direction perpendicular to the above-mentioned axial direction.

[0054] The natural state of medical devices such as embedded branches refers to the natural expanded state of the medical device when not subject to external forces.

[0055] See also Figure 2 to Figure 4(A) The embodiment of the present invention provides an iliac vein stent 100, comprising a main stent 10, an embedded branch 20 and a second branch 30. The main stent 10 comprises a main body 11 and a first branch 12 connected to the distal end of the main body 11. The embedded branch 20 is arranged in the main body 11 after being folded and shaped, and part of the outer wall of the embedded branch 20 is fixedly connected to the inner wall of the main stent 10; compared with the natural state, the minimum distance between the embedded branch 20 and the center of the main body 11 becomes larger in the folded and shaped state. The second branch 30 is embedded in the embedded branch 20 and connected to the main stent 10. Exemplarily, the minimum distance between the embedded branch 20 and the center of the main body 11 is shown as D1 in FIG. 4(B). D1 in the folded and shaped state is greater than D1 in the natural state. Exemplarily, the maximum distance between the embedded branch 20 and the center of the main body 11 is shown as D2 in FIG. 4(B).

[0056] Compared with the embedded branch made of high elastic material and arranged in the main stent in a natural state, the embedded branch 20 of this embodiment is arranged in the main body 11 after being folded and shaped. The elastic recovery force of the embedded branch 20 in the folded and shaped state is small or even negligible. When the iliac vein stent 100 is located in the sheath 202, the squeezing force between the embedded branch 20 and the inner sheath core 201 is small or even no mutual squeezing occurs; when the compressed iliac vein stent 100 moves in the sheath 202, the friction between the embedded branch 20 and the inner sheath core 201 can be reduced as much as possible, so that the damage of the inner sheath core 201 to the embedded branch 20 can be effectively reduced during the process of the iliac vein stent 100 being sheathed or unsheathed, thereby protecting the embedded branch 20. After the iliac vein stent 100 is unsheathed, the embedded branch 20 can be switched from the folded and shaped state to the natural state, so that the embedded branch 20 can be used to connect the second branch 30.

[0057] See also Figure 2, exemplarily, the main body 11 includes a first opening 111, the embedded branch 20 is fixedly connected to the inner wall of the main support 10, and the second branch 30 can be embedded in the embedded branch 20 through the first opening 111. The angle between the end face where the first opening 111 is located and the cross section is in the range of [0°, 40°], so as to better conform to the blood vessel structure and better connect with the second branch 30.

[0058] See also Figure 2 The main body 11 includes a second opening 112, and the second opening 112 and the first opening 111 are respectively arranged at both ends of the main body 11. The grid density of different areas of the main body 11 can be the same or different. The different grid densities in different areas of the main body 11 can achieve different radial support force designs. For example, the grid density of the area of ​​the main body 11 close to the first opening 111 is designed to be denser to design a strong radial support force. The grid density of the area of ​​the main body 11 close to the second opening 112 is designed to be sparser to design a weak radial support force, thereby reducing the stimulation to the inferior vena cava blood vessels, preventing vascular intimal hyperplasia, and further restenosis.

[0059] Exemplarily, in the natural state, the angle between the end face of the embedded branch 20 near the first opening 111 and the cross section is in the range of [0°, 40°], and the cross section is perpendicular to the axial direction of the iliac vein stent 100, so as to better conform to the vascular structure and better connect with the second branch 30. Exemplarily, in the natural state, the end face of the first opening 111 of the main body 11 is roughly parallel to the end face of the second branch 30 near the first opening 111, so as to facilitate the second branch 30 to be better embedded in the embedded branch 20.

[0060] In some embodiments, in the natural state, the cross-section of the embedded branch 20 is circular, as shown in FIG. 4(A); in the folded and shaped state, at least part of the inner walls of the embedded branch 20 are close to each other so that the cross-section of the embedded branch 20 is non-circular, as shown in FIG. Figure 3 This helps reduce the radial dimension of the embedded branch 20 in the folded and shaped state, and further helps reduce the radial dimension of the iliac vein stent 100 when it is received in the sheath tube 202, making it easier for the iliac vein stent 100 to be received in a smaller sheath tube 202 for transportation, and helping reduce damage to the human body.

[0061] See also Figure 3In some embodiments, in the folded and shaped state, the inner walls of the embedded branches 20 are bent and formed into an arch after being attached to each other. In this way, the embedded branches 20 are arranged in the main body 11 after being folded and shaped, which can reduce the surface area of ​​the embedded branches 20, thereby reducing the contact area between the embedded branches 20 and the inner sheath core 201 during the sheathing process of the iliac vein stent 100. Therefore, when the iliac vein stent 100 received in the sheath tube 202 moves in the sheath tube 202, the degree of mutual squeezing and friction between the embedded branches 20 in the folded and shaped state and the inner sheath core 201 is reduced, thereby reducing the degree of damage to the embedded branches 20 during the movement of the iliac vein stent 100 as much as possible.

[0062] See also Figure 6 and Figure 7 In some embodiments, in the folded shaping state, the two free ends of the arched embedded branch 20 are further bent toward each other to form a C-shape. In this way, during the sheathing process of the iliac vein stent 100, the area of ​​the embedded branch 20 in contact with the inner sheath core 201 is the end area of ​​the free end of the C-shaped embedded branch 20, and there is no need for the embedded branch 20 to be in surface contact with the inner sheath core 201, which effectively reduces the contact area between the embedded branch 20 and the inner sheath core 201 during the sheathing process of the iliac vein stent 100. When the iliac vein stent 100 moves in the sheath tube 202, the degree of mutual extrusion and friction between the embedded branch 20 in the folded shaping state and the inner sheath core 201 can be reduced as much as possible, thereby reducing the degree of damage to the embedded branch 20 during the sheathing process of the iliac vein stent 100 as much as possible. In other embodiments, in the folded shaping state, the shape of the embedded branch 20 can also be other shapes.

[0063] For example, Figure 8 and Fig. 9 After the embedded branch 20 in a natural state is completed, it can be molded by the first molding mold 1000a. The first molding mold 1000a includes a first pressing tool 1001 and a first placing tool 1002. The structure of the first pressing tool 1001 and / or the first placing tool 1002 is hollow, and the appropriate plastic temperature (60°C-120°C) can be provided by heating the liquid (water, oil, etc.) inside. When the embedded branch 20 is molded once, the embedded branch 20 is placed in the groove of the first placing tool 1002, and the first pressing tool 1001 is pressed down at a certain speed (for example, 100mm / s-500mm / s), and the pressure is maintained at 0.1mpa-0.2mpa for 3S-10S, and then the first pressing tool 1001 is lifted to complete the molding. The shape of the embedded branch 20 after the molding is as follows. Fig. 9 Similarly, see Fig.10 and Fig.11Then, the embedded branch 20 that has completed the primary shaping is subjected to secondary shaping by the second shaping mold 1000b. The second shaping mold 1000b includes a second pressing tool 1003 and a second placing tool 1004. The embedded branch 20 that has completed the primary shaping is placed in the groove of the second placing tool 1004, and the second pressing tool 1003 is pressed down at a certain speed (for example, 50mm / s-100mm / s), and the pressure is maintained at 0.1mpa-0.2mpa for 1S-2S, and then the second pressing tool 1003 is lifted, and the secondary shaping is completed. The shape of the embedded branch 20 after the secondary shaping is as shown in FIG. Fig.11 shown.

[0064] See also Fig.12 In some embodiments, the embedded branch 20 includes a mesh reinforcement layer 21 and a coating layer 22, and the mesh reinforcement layer 21 and the coating layer 22 are integrally formed. In this way, the preparation of the embedded branch 20 is simple, and the connection between the mesh reinforcement layer 21 and the coating layer 22 is reliable. In other embodiments, the mesh reinforcement layer 21 and the coating layer 22 can also be provided separately, and the coating layer 22 can be provided only on the inner side of the mesh reinforcement layer 21, or the coating layer 22 can be provided on both the inner and outer sides of the mesh reinforcement layer 21. In other embodiments, the mesh reinforcement layer 21 can also be omitted.

[0065] See also Fig.12 In some embodiments, the mesh reinforcement layer 21 includes a plurality of first-direction reinforcement wires 211 and a plurality of second-direction reinforcement wires 212, the first-direction reinforcement wires 211 and the second-direction reinforcement wires 212 overlap each other to form the mesh reinforcement layer 21, and the coating layer 22 covers one side or both sides of the mesh reinforcement layer 21. The first-direction reinforcement wires 211 and the second-direction reinforcement wires 212 can reinforce the embedded branches 20 from two directions, and can effectively improve the mechanical strength of the embedded branches 20.

[0066] The mesh reinforcement layer 21 and the coating layer 22 can be made of polymer materials or other suitable materials. In some embodiments, the mesh reinforcement layer 21 and the coating layer 22 are made of one or more of polylactic acid, polycaprolactone, and polycarbonate to reduce the risk of blood reflux and the probability of thrombosis.

[0067] In order to improve the mechanical strength of the coating layer 22 and regulate the absorbable time, a mesh reinforcement layer 21 with high crystallinity can be embedded in the coating layer 22. For example, the mesh reinforcement layer 21 is set on one side or both sides of the coating layer 22, and the material of the mesh reinforcement layer 21 includes one of polylactic acid, polycaprolactone, and polycarbonate. Furthermore, the surface of the coating layer 22 can be added with drugs that inhibit intimal hyperplasia in some way to further reduce the risk of vascular stenosis. Furthermore, the drug that inhibits intimal hyperplasia can be added by one or more methods such as physical spraying and chemical dipping. The connection between the embedded branch 20 and the main stent 10 can be sutured and fixed by polymer wire.

[0068] For example, see Fig.13 and Fig.14 In the embedded branch 20, the coating layer 22 and the mesh reinforcement layer 21 can be the same degradable material, such as polylactic acid. The molding method of the embedded branch 20 can be an electrostatic spinning method. The embedded branch 20 may include a four-layer structure, namely a coating layer 22a, a first intermediate layer 23, a second intermediate layer 24 and a coating layer 22b. The coating layer 22a and the coating layer 22b can be electrostatically spun using the same process parameters, such as: voltage 26kV-30kV, the distance between the spinneret 2001 and the rotating receiving circular shaft 2002 is 10cm-12cm, the extrusion speed is 8μL / min-10μL / min, the lateral horizontal movement speed of the spinneret 2001 is 5mm / s-20mm / s, and the rotation speed of the electrostatic spinning fiber collection rotating receiving circular shaft 2002 is 500r / min-600r / min to form a membrane structure. The first intermediate layer 23 is subjected to electrostatic spinning, but the horizontal movement speed of the spinneret 2001 is 5-7 times that of the coating layer 22a and the coating layer 22b (because it moves fast in the horizontal direction, it can only form a screen structure). The density of the first intermediate layer 23 can be adjusted by the movement speed in the first direction. For other parameters, refer to the coating layer 22a and the coating layer 22b. The second intermediate layer 24 is subjected to electrostatic spinning, but the spinneret does not move in the first direction, but only moves in the second direction at 5-7 times the speed of the coating layer 22a and the coating layer 22b. The density of the structure can be adjusted by the vertical horizontal movement speed. For other parameters, refer to the coating layer 22a and the coating layer 22b. Fig.14 2003 is a polylactic acid solution, and 2004 is a polylactic acid solution yarn. Exemplarily, one of the first intermediate layer 23 and the second intermediate layer 24 corresponds to the first direction reinforcing yarn 211, and the other of the first intermediate layer 23 and the second intermediate layer 24 corresponds to the second direction reinforcing yarn 212. In this embodiment, the coating layer 22 includes two layers, namely, a coating layer 22a and a coating layer 22b. In other embodiments, the number of the coating layer 22 can also be one layer, three layers, or other number of layers.

[0069] For example, Fig.15 In the embedded branch 20, the coating layer 22 and the mesh reinforcement layer 21 can be made of different degradable materials, for example, one of the coating layer 22 and the mesh reinforcement layer 21 is polycarbonate and the other is polylactic acid. The embedded branch 20 can be divided into a two-layer structure, and the molding method can include an immersion and pulling method, which is as follows: the tool 3001 equipped with the mesh reinforcement layer 21 is immersed in the coating liquid 3002 at an angle of 90°-75°, and a certain immersion time of 10S-30S is maintained to allow the coating liquid to fully wet the mesh reinforcement layer 21, and then the tool 3001 equipped with the mesh reinforcement layer 21 is pulled out of the coating liquid 3002 at 2-10mm / s, and finally the solvent is volatilized by heating or other methods to complete the preparation of the coating layer 22. Exemplarily, the mesh reinforcement layer 21 is a mesh polycarbonate filament, and the coating liquid 3002 is a polylactic acid solution; or, the mesh reinforcement layer 21 is a mesh polylactic acid filament, and the coating liquid 3002 is a polycarbonate solution.

[0070] See also Fig.16 The embodiment of the present invention further provides an iliac vein stent system, including an iliac vein stent 100 and a conveyor 200, wherein the iliac vein stent 100 includes the iliac vein stent 100 of any of the above embodiments. The conveyor 200 is used to convey the iliac vein stent 100, so as to implant the iliac vein stent 100 into the iliac vein in a living body, thereby supporting the iliac vein segment, thereby alleviating the risk of local lumen stenosis of the iliac vein segment.

[0071] See also Fig.16 and Fig.17In some embodiments, the conveyor 200 includes a handle 203, a sheath tube 202, an inner sheath core 201 and an outer sheath core 204, and the proximal side of the sheath tube 202 is connected to the handle 203. The inner sheath core 201 is slidably arranged in the sheath tube 202, and the proximal side of the inner sheath core 201 is connected to the handle 203. The outer sheath core 204 is sleeved outside the inner sheath core 201, and the outer sheath core 204 is in the sheath tube 202, and the proximal side of the outer sheath core 204 is fixedly connected to the handle 203. The iliac vein stent 100 is sleeved on the inner sheath core 201, and the iliac vein stent 100 is located in the sheath tube 202, and an expansion device 300 is provided in the embedded branch 20, and the expansion device 300 can expand the embedded branch 20 from a folded and shaped state to a natural state. It can be understood that in actual application, the main stent 10 and the embedded branch 20 are connected to form a combination, and the combination can be received in the sheath tube 202. The operator can first implant the combination into the iliac vein at a preset position in the body through the conveyor 200, and then remove the combination from the sheath 202. After the combination is removed from the sheath 202, the embedded branch 20 can be expanded from the folded and shaped state to the natural state through the expansion device 300 to ensure that the second branch 30 can be embedded in the embedded branch 20 and connected to the main stent 10. After the embedded branch 20 is expanded to the natural state, the second branch 30 can be implanted into the body through the conveyor 200, and the second branch 30 can be embedded in the embedded branch 20, so that the iliac vein stent 100 can support the blood vessel to alleviate the risk of local lumen stenosis of the blood vessel.

[0072] It is understandable that the expansion device 300 can be pre-placed in the conveyor 200. For example, before the iliac vein stent system is shipped out of the factory, the expansion device 300 is pre-placed in the conveyor 200. For another example, after the iliac vein stent system is shipped out of the factory and before the iliac vein stent 100 is implanted, the expansion device 300 is pre-placed in the conveyor 200.

[0073] Exemplarily, the expansion device 300 includes an elastic expansion device 300. For example, the expansion device 300 includes an elastic membrane, so that the structure of the expansion device 300 is simple. It can be understood that the elastic membrane includes a cavity (not shown), and fluid such as gas or liquid can be injected into the cavity to allow the expansion device 300 to expand, thereby expanding the embedded branch 20 from a folded and shaped state to a natural state.

[0074] See also Figures 17 to 19In some embodiments, the iliac vein stent system further includes a connecting tube 400, and a through-channel 2041 is provided on the tube wall of the outer sheath core 204. The through-channel 2041 extends axially from the proximal side of the outer sheath core 204 to the distal end face of the outer sheath core 204. The distal end of the connecting tube 400 passes through the through-channel 2041 and communicates with the expansion device 300, and the proximal end of the connecting tube 400 extends from the through-channel 2041 and communicates with the outside of the handle 203. Gas or liquid can be delivered to the expansion device 300 through the connecting tube 400, so that the expansion device 300 expands the embedded branch 20 from a folded and shaped state to a natural state; the through-channel 2041 can be used to accommodate the expansion device 300. After the embedded branch 20 is expanded to the natural state and the expansion device 300 is restored to its original state, the expansion device 300 can be stored in the through-channel 2041, so that the expansion device 300 can be withdrawn from the organism along with the conveyor 200. When the expansion device 300 is stored in the through-channel 2041, as shown in FIG. Fig.19 See Fig.18 Exemplarily, the outer sheath core 204 is provided with a sheath core channel 2042, and the sheath core channel 2042 is used for the inner sheath core 201 to pass through.

[0075] It should be noted that the through-channel 2041 extends axially from the proximal side of the outer sheath core 204 to the distal end to the distal end face of the outer sheath core 204. The proximal end or proximal side of the outer sheath core 204 is just an orientation description, referring to this side of the proximal end, but not specifically referring to a certain part. The through-channel 2041 may extend to the proximal end face of the outer sheath core 204, or may not extend to the proximal end face of the outer sheath core 204 and radially penetrate the outer wall of the outer sheath core 204 in advance. The proximal end face of the outer sheath core 204 refers to the end face of the proximal end of the outer sheath core 204. The distal end face of the outer sheath core 204 refers to the end face of the distal end of the outer sheath core 204. The proximal end or proximal side of other components is similar.

[0076] See also Fig.16 , Fig. 20 In some embodiments, a pipe joint 500 is movably connected to the handle 203, and the proximal side of the connecting tube 400 is fixedly connected to the pipe joint 500 and communicated with each other. When it is necessary to input gas or liquid into the expansion device 300, or when it is necessary to extract gas or liquid from the expansion device 300, the pipe joint 500 can be connected to the handle 203; when it is not necessary to input gas or liquid into the expansion device 300, or when it is not necessary to extract gas or liquid from the expansion device 300, the pipe joint 500 can be removed from the handle 203. Since the proximal side of the connecting tube 400 is fixedly connected to the pipe joint 500 and communicated with each other, gas or liquid can enter the connecting tube 400 through the pipe joint 500, and then reach the expansion device 300; the gas or liquid in the expansion device 300 can also enter the pipe joint 500 through the connecting tube 400 and be discharged.

[0077] Before the iliac vein stent 100 is loaded into the sheath tube 202, the expansion device 300 and the connecting tube 400 can pass through the proximal end of the conveyor 200 through the through channel 2041 to the distal end of the conveyor 200 and extend out of the sheath tube 202, and then the expansion device 300 is pre-placed in the embedded branch 20. Then, the assembly formed by connecting the main stent 10 and the embedded branch 20 is compressed and loaded into the sheath tube 202. Since the expansion device 300 is connected to the connecting tube 400, and the connecting tube 400 has a certain axial support strength, the existence of the expansion device 300 can not only expand the embedded branch 20, but also improve the support performance of the embedded branch 20 side of the entire iliac vein stent 100, and has a certain axial limiting effect on the iliac vein stent 100, which can reduce the risk of shortening of the iliac vein stent 100.

[0078] After the combination formed by the connection of the main support 10 and the embedded branch 20 is released by pulling the handle 203, and before the second branch 30 is inserted, physiological saline can be injected into the expansion device 300 through the tube joint 500 with a syringe, and the expansion device 300 expands until the embedded branch 20 that has been folded and shaped is expanded. After the internal channel 25 of the embedded branch 20 (please refer to Figure 4 (A)) is expanded, a channel is established for the implantation of the second branch 30. After the channel is established, the physiological saline is extracted with a syringe, and the expansion device 300 returns to its original state. One end of the connecting tube 400 is connected to the expansion device 300, and the other end of the connecting tube 400 is connected to the tube joint 500. Physiological saline can enter the connecting tube 400 through the tube joint 500, and then enter the expansion device 300. Please refer to Fig.16 As shown, the pipe connector 500 is threadedly connected to the handle 203. Fig. 20 As shown, when the expansion device 300 is restored to its original state, the tube connector 500 is rotated to separate the tube connector 500 from the handle 203, and then the tube connector 500 is pulled to drive the connecting tube 400 and the expansion device 300 to move toward the proximal end, and the expansion device 300 is pulled into the through channel 2041. Finally, the expansion device 300 can be withdrawn from the organism along with the conveyor 200.

[0079] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "illustrative embodiments", "examples", "specific examples", or "some examples" means that the specific method steps, features, structures, materials, or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific method steps, features, structures, materials, or characteristics described may be combined in any one or more embodiments or examples in a suitable manner.

[0080] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can easily think of various equivalent modifications or replacements within the technical scope disclosed by the present invention, and these modifications or replacements should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be based on the protection scope of the claims.

Claims

1. An iliac vein stent, characterized in that: include: The main body support comprises a main body portion and a first branch connected to the distal end of the main body portion; An embedded branch, which is arranged in the main body after being folded and shaped, and a part of the outer wall of the embedded branch is fixedly connected to the inner wall of the main body support; compared with the natural state, the minimum distance between the embedded branch and the center of the main body is larger in the folded and shaped state; The second branch can be embedded in the embedded branch and connected to the main support.

2. The iliac vein stent according to claim 1, characterized in that: In a natural state, the cross-section of the embedded branch is circular; in a folded and shaped state, at least part of the inner walls of the embedded branch are close to each other so that the cross-section of the embedded branch is non-circular.

3. The iliac vein stent according to claim 2, characterized in that: In the folded and shaped state, the embedded branches are bent and folded to form a bow shape.

4. The iliac vein stent according to claim 3, characterized in that: In the folded and shaped state, the two free ends of the arched embedded branches are further bent toward each other to form a C shape.

5. The iliac vein stent according to claim 1, characterized in that: The embedded branch comprises a mesh reinforcement layer and a coating layer, and the mesh reinforcement layer is arranged on the coating layer.

6. The iliac vein stent according to claim 5, characterized in that: The mesh reinforcement layer includes a plurality of first-direction reinforcement wires and a plurality of second-direction reinforcement wires. The first-direction reinforcement wires and the second-direction reinforcement wires overlap with each other to form the mesh reinforcement layer. The coating layer covers one side or both sides of the mesh reinforcement layer.

7. The iliac vein stent according to claim 5, characterized in that: The mesh reinforcement layer and the coating layer are made of one or more of polylactic acid, polycaprolactone and polycarbonate.

8. An iliac vein stent system, comprising the iliac vein stent and a conveyor according to any one of claims 1 to 7, characterized in that: The conveyor comprises: handle; A sheath tube, the proximal end side of which is connected to the handle; An inner sheath core is slidably disposed in the sheath tube and a proximal end side of the inner sheath core is connected to the handle; An outer sheath core is sleeved outside the inner sheath core and is located in the sheath tube, and a proximal end side of the outer sheath core is fixedly connected to the handle; The iliac vein stent is sleeved on the inner sheath core and is located in the sheath tube. An expansion device is arranged in the embedded branch, and the expansion device can expand the embedded branch from a folded and shaped state to a natural state.

9. The iliac vein stent system according to claim 8, characterized in that: It also includes a connecting tube, a through channel is provided on the tube wall of the outer sheath core, the through channel extends axially from the proximal side of the outer sheath core to the distal end face of the outer sheath core, the distal end of the connecting tube passes through the through channel and is connected with the expansion device, and the proximal end of the connecting tube extends from the through channel and is connected with the outside of the handle.

10. The iliac vein stent system according to claim 9, characterized in that: The handle is movably connected with a pipe joint, and the proximal end side of the connecting pipe is fixedly connected to the pipe joint and communicated with each other.

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