Support and support system

Abstract

The invention relates to a stent, the stent comprises a covering film and a plurality of wave rings, and in a natural state, the plurality of wave rings are mutually spaced along the axial direction of the covering film; the wave ring comprises a plurality of rhombic structures and a winding wire, and the winding wire is wound on the rhombic structures so as to connect the rhombic structures. The stent system comprises the stent and further comprises a balloon catheter assembly, the balloon catheter assembly comprises a catheter, a balloon and a filter, the balloon is arranged at the far end of the catheter, and the filter is arranged at the far end of the catheter and close to the near end side of the balloon. When the stent is non-uniformly expanded, the mutual influence of the adjacent wave rings is reduced as much as possible, so that the stent is prevented from shifting, shortening or slipping off from the balloon due to non-uniform stress in the expansion process. In addition, the degree of freedom of a single rhombic structure can be ensured. And the stent is prevented from being shaped into a bent shape during expansion.

Description

Technical Field

[0001] This invention relates to the field of interventional medicine, specifically to a stent and a stent system. Background Technology

[0002] In recent years, interventional therapy has become a growing trend in the treatment of cardiovascular diseases. With the continuous development of interventional techniques, the advantages of using stents to treat vascular lesions have become increasingly prominent. Balloon-expandable stents are one type of stent, where a stent is placed on a balloon, which is then inflated to expand and support the stent within the blood vessel. However, existing balloon-expandable stents have several drawbacks. First, the balloon may inflate unevenly during inflation. For example, if one end of the balloon inflates first, that end of the stent will expand first. This uneven stress can cause displacement of the stent relative to the balloon, preventing it from expanding fully or causing it to slip off. Second, uneven inflation can also lead to stent shortening. If both ends of the balloon inflate first, the ends of the stent will expand first, resulting in a force pushing the stent towards its center, causing shortening and preventing it from effectively supporting the lesion. Third, uneven inflation can also cause the stent to be deformed, for example, becoming bent after expansion, which affects its apposition to the vessel wall and impacts the overall surgical outcome. Summary of the Invention

[0003] To overcome the problems existing in the prior art, the present invention provides a novel support and support system.

[0004] The solution to the technical problem of the present invention is to provide a stent for interventional treatment of vascular lesions. The stent includes a membrane and multiple wave coils. In its natural state, the multiple wave coils are spaced apart from each other along the axial direction of the membrane. Each wave coil includes multiple rhomboid structures and a winding wire. The winding wire is wound around the multiple rhomboid structures to connect the multiple rhomboid structures.

[0005] In some embodiments of the present invention, the rhombus structure has a proximal end and a distal end, and the number of winding wires is two. One winding wire starts from the proximal end of one rhombus structure and winds to the middle part, and extends out of the rhombus structure from the middle part and enters the other rhombus structure. It then winds from the middle part of the other rhombus structure toward the distal end. The other winding wire starts from the distal end of one rhombus structure and winds to the middle part, and extends out of the rhombus structure from the middle part. It intertwines with the first winding wire and enters the other rhombus structure. It then winds from the middle part of the other rhombus structure toward the proximal end.

[0006] In some embodiments of the present invention, a plurality of rhomboid structures of one wave loop are staggered with a plurality of rhomboid structures of an adjacent wave loop; and the central axis of the rhomboid structure of one wave loop is collinear with the centerline between two adjacent rhomboid structures on an adjacent wave loop.

[0007] In some embodiments of the present invention, a plurality of rhomboid structures of one wave loop are arranged in a one-to-one correspondence with a plurality of rhomboid structures of adjacent wave loops.

[0008] In some embodiments of the present invention, the wave loop is woven from metal wire, or the rhomboid structure is cut from a metal tube, the winding wire is made of metal wire, and the proximal and distal ends of the rhomboid structure include arc-shaped structures and / or linear structures; the spacing between two adjacent wave loops is 0.2mm-0.6mm.

[0009] In some embodiments of the present invention, the stent further includes a filling portion having a cavity, the filling portion being disposed on the outer surface of the membrane, and the cavity of the filling portion being filled with a filling liquid.

[0010] In some embodiments of the present invention, the end of the bracket includes an end corrugated ring, the end corrugated ring including a first corrugated ring and a second corrugated ring, the first corrugated ring and the second corrugated ring being spaced apart, and the filling portion being disposed between the first corrugated ring and the second corrugated ring.

[0011] In some embodiments of the present invention, the filling portion has an annular structure and is disposed between two adjacent wave loops.

[0012] In some embodiments of the present invention, the number of filling portions is multiple, the filling portions are linear in structure, and the multiple filling portions are disposed between every two adjacent rhomboid structures of each wave loop.

[0013] In some embodiments of the present invention, the filling portion includes a plurality of annular filling portions and linear filling portions. The annular filling portions are disposed between two adjacent wave loops, and the plurality of linear filling portions are disposed between every two adjacent rhomboid structures of each wave loop. The plurality of annular filling portions and linear filling portions are interconnected.

[0014] The solution to the technical problem of the present invention is to provide a stent system, the stent system including the stent as described in any of the preceding claims, the stent system further including a balloon catheter assembly, the balloon catheter assembly including a catheter, a balloon and a filter, the balloon being disposed at the distal end of the catheter, and the filter being disposed at the distal end of the catheter and close to the proximal side of the balloon.

[0015] Compared with existing technologies, the stent and stent system of the present invention have the following advantages: Firstly, the main body of the coils in the present invention adopts a rhomboid structure, ensuring the overall support, extensibility, and expandability of the stent. Simultaneously, the rhomboid structure has better wall-adhering performance, preventing blood leakage. Secondly, multiple coils are spaced apart from each other, and there are no connecting parts between them. This minimizes the mutual influence between adjacent coils during uneven expansion, reducing the force transmission between adjacent coils and preventing displacement, shortening, or slippage from the balloon due to uneven force during expansion. Furthermore, the stent uses multiple rhomboid structures individually arranged, and these structures are connected by the winding wire to maximize the freedom of each individual rhomboid structure. When a single rhomboid structure is under stress, the force transmission to adjacent rhomboid structures is minimized. This prevents a single rhomboid structure from experiencing excessive force during uneven balloon inflation, which could cause deformation of the remaining rhomboid structures and prevent the stent from being molded into a bent shape during expansion. Meanwhile, connecting multiple rhomboid structures through the winding wire can improve the overall adaptability of the stent, so that even if the stent rotates, bends or shortens, it can adapt to the above situations and ensure the medical effect of the stent. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the three-dimensional structure of the support provided in the first embodiment of the present invention.

[0017] Figure 2 This is a partial structural diagram of the waveguide and adjacent waveguides of the support provided in the first embodiment of the present invention.

[0018] Figure 3 This is a schematic diagram of the rhomboid structure of the bracket provided in the first embodiment of the present invention.

[0019] Figure 4 This is a schematic diagram of a partial structure of the wave ring formed by cutting the metal tube of the bracket provided in the first embodiment of the present invention.

[0020] Figure 5 This is a schematic diagram of the three-dimensional structure of the diamond-shaped structure formed by cutting the metal tube of the bracket provided in the first embodiment of the present invention.

[0021] Figure 6 This is a schematic diagram of a three-dimensional support structure provided in another embodiment of the first embodiment of the present invention.

[0022] Figure 7 This is a perspective structural diagram of the filling portion of the stent provided in the first embodiment of the present invention when it is not expanded.

[0023] Figure 8 This is a perspective structural diagram of the expanded filling portion of the stent provided in the first embodiment of the present invention.

[0024] Figure 9 This is a schematic diagram of a three-dimensional support structure provided in another embodiment of the first embodiment of the present invention.

[0025] Figure 10 This is a schematic diagram of a partial three-dimensional structure of a bracket provided in another embodiment of the first embodiment of the present invention.

[0026] Figure 11 This is a schematic diagram of a partial three-dimensional structure of a bracket provided in another embodiment of the first embodiment of the present invention.

[0027] Figure 12 This is a schematic diagram of a three-dimensional support structure provided in another embodiment of the first embodiment of the present invention.

[0028] Figure 13 This is a schematic diagram of the end bevel structure of the bracket provided in the first embodiment of the present invention.

[0029] Figure 14 This is a schematic diagram of the support system structure provided in the second embodiment of the present invention.

[0030] Figure 15 This is a perspective structural diagram of the support, balloon, and filter of the support system provided in the second embodiment of the present invention housed within a sheath.

[0031] Figure 16 This is a perspective view of the expanded support structure of the support system provided in the second embodiment of the present invention.

[0032] Figure 17 This is a perspective view of the balloon decompression and filter recovery structure inside the sheath of the stent system provided in the second embodiment of the present invention.

[0033] Figure 18 This is a perspective structural diagram of the filter released within the support structure of the support system provided in the second embodiment of the present invention.

[0034] Figure 19 This is a perspective structural diagram of the filter and support structure of the support system provided in the second embodiment of the present invention.

[0035] Explanation of reference numerals in the attached diagram: 100, support; 11, corrugated coil; 111, rhomboid structure; 1111, arc-shaped structure; 1112, linear structure; 112, wire winding; 12, membrane covering; 13, filling part; 14, end corrugated coil; 141, first corrugated coil; 142, second corrugated coil; 200, support system; 2, balloon catheter assembly; 21, catheter; 22, balloon; 23, filter; 231, filter wire; 2311, barb; 232, retaining ring; 3, sheath. Detailed Implementation

[0036] Exemplary embodiments of the invention will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the invention and to fully convey the scope of the invention to those skilled in the art.

[0037] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0038] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0039] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0040] To more clearly describe the structure of this application, the terms "proximal" and "distal" are used herein as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end furthest from the operator during the surgical procedure, "proximal" refers to the end closest to the operator during the surgical procedure, "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial".

[0041] Please see Figure 1 and Figure 2 The first embodiment of this invention provides a stent 100 for interventional treatment of vascular lesions. The stent 100 of this invention is particularly suitable for use with a balloon. By fitting the stent 100 onto the balloon, the balloon inflates and expands the stent 100, supporting it within the blood vessel. The stent 100 of this invention is described in detail using a balloon-expandable stent as an example. The stent 100 includes multiple coils 11 and a covering 12. In its natural state, the multiple coils 11 are spaced apart from each other along the axial direction of the covering 12. That is, regardless of whether the stent 100 is in an expanded or compressed state, as long as the stent 100 is not subjected to external force, the stent 100 is in a straight shape, such as... Figure 1 The state shown is the natural state. The wave coil 11 includes a plurality of rhomboid structures 111 and a winding wire 112, which is wound around the plurality of rhomboid structures 111 to connect the plurality of rhomboid structures 111.

[0042] In a specific embodiment of the present invention, the length of the rhomboid structure 111 in the axial direction is greater than the length of the rhomboid structure 111 in the circumferential direction. This ensures that the stent 100 maintains overall support while reducing the force required for expansion, ensuring that the stent 100 expands fully and can closely conform to the inner wall of the blood vessel. The winding wire 112 begins to wind along the four sides of one rhomboid structure 111. After winding one rhomboid structure 111, it begins to wind adjacent rhomboid structures 111, and so on, until the first and last two rhomboid structures 111 of a loop are connected. After the winding wire 112 winds and connects one loop of the rhomboid structure 111, a loop 11 is formed. The covering membrane 12 is a double-layer covering membrane, that is, the covering membrane has an outer covering membrane and an inner covering membrane, and the loop 11 is disposed between the outer covering membrane and the inner covering membrane. The main body of the wave coil 11 of this invention adopts a rhomboid structure 111, which first ensures the overall support, extensibility, and expandability of the support 100. Simultaneously, the rhomboid structure 111 has better wall-adhering performance, preventing blood leakage. Secondly, multiple wave coils 11 are spaced apart, and no connecting parts are used between them. This minimizes the mutual influence of adjacent wave coils 11 during uneven expansion of the support 100, reducing the force transmission between adjacent wave coils 11 and preventing displacement, shortening, or slippage from the balloon due to uneven force during expansion. Furthermore, the support 100 uses multiple rhomboid structures 111 individually, and these structures are connected by the winding wire 112 to maximize the degree of freedom of each individual rhomboid structure 111. In other words, during expansion, the expansion of the support 100 minimizes the impact of the expansion of a single rhomboid structure 111 on adjacent rhomboid structures 111. In other words, when a single rhomboid structure 111 is subjected to force, the force transmission to adjacent rhomboid structures 111 can be minimized. This prevents a single rhomboid structure 111 from experiencing excessive force during uneven inflation of the balloon, which could cause deformation of the remaining rhomboid structures 111. Consequently, the stent 100 is prevented from being molded into a bent shape during expansion. Furthermore, connecting multiple rhomboid structures 111 via the winding wire 112 improves the overall adaptability of the stent 100. This allows the stent 100 to adapt to situations such as rotation, bending, or shortening, ensuring the medical efficacy of the stent 100.

[0043] In other specific embodiments of the present invention, the wave coil 11 may also be disposed on the outer surface of the covering membrane 12 to increase the friction between the stent 100 and the blood vessel wall, thereby increasing the anchoring force of the stent 100.

[0044] Further, please refer to Figure 1 - Figure 3In a specific embodiment of the present invention, the spacing S between two adjacent coils 11 is 0.2mm-0.6mm, thereby ensuring that the stent 100 can balance overall support and flexibility while reducing the mutual influence between adjacent coils 11. The coils 11 are woven from metal wires, meaning that both the rhomboid structure 111 and the winding wire are made of metal wires, specifically nickel-titanium wire, stainless steel wire, etc. The proximal and distal ends of the rhomboid structure 111 include arc-shaped structures 1111, thereby reducing the stimulation of the blood vessel by the stent 100 and reducing the force required for the stent 100 to expand, ensuring smooth expansion of the stent 100. In other specific embodiments of the present invention, the rhomboid structure 111 can be cut from a metal tube, and multiple rhomboid structures 111 cut from metal tubes can be connected by the winding wire 112, such as... Figure 4 As shown. This increases the anchoring force of the stent 100 after expansion, and also increases the support of the stent 100, ensuring that the stent 100 can be stably supported within the diseased blood vessel. The metal tube can be made of nickel-titanium alloy, stainless steel, etc. To reduce the difficulty of cutting the metal tube into the rhomboid structure 111, the proximal and distal ends of the rhomboid structure 111 can be set as linear structures 1112, that is, the rhomboid structure 111 is a hexagonal structure, which can further increase the support of the stent 100. Alternatively, the proximal and distal ends of the rhomboid structure 111 cut from the metal tube can be set as arc-shaped structures 1111, such as... Figure 5 As shown.

[0045] It should be noted that the stent 100 provided in the first embodiment of the present invention is particularly suitable for animal experiments. For example, in the early stages of product development, small animals such as rabbits and rats are typically used for experiments. However, because small experimental animals have smaller blood vessels and thinner vessel walls, in some animal experiments, it is necessary to reduce the size of the stent used for humans and place it into the animal's blood vessels, requiring the special manufacture of stents for small animals. Furthermore, self-expanding stents may cause compression or damage to the animal's blood vessels, thus affecting the experimental results. After completing the early animal experimental studies, experiments will be conducted using animals with blood vessel size, anatomical characteristics, and neointimal growth similar to human blood vessels. At this time, it is necessary to specially manufacture stents suitable for such animals. The stent 100 provided in the first embodiment of the present invention, because the individual rhomboid structure 111 has a large degree of freedom and the influence between adjacent coils 11 is small, can be compressed to a smaller size and has a large range of expandable dimensions, that is, the stent 100 can be expanded to 4mm-40mm. The stent 100 can be expanded according to actual needs. For example, if a stent with a diameter of 20mm is required, the balloon can be controlled to expand the stent 100 to 20mm. Therefore, the stent 100 can be adaptively adjusted according to the diameter of the animal's blood vessels, expanding to a suitable size to avoid compression or damage to the animal's blood vessels. Simultaneously, there is no need to manufacture stents 100 of various specifications, nor to select different specifications of stents 100 for different experimental subjects, facilitating animal experiments. Because the stent 100 is convenient for animal experiments, it can be directly used for drug research. For example, the drug to be studied can be coated on the outer surface of the stent 100, and then the stent 100 can be implanted into the animal's blood vessels to observe drug release, absorption efficiency, changes in molecular weight distribution, mass loss, etc., thereby verifying the uniformity and controllability of drug release and whether it meets clinical requirements. Therefore, the stent 100 of the first embodiment of the present invention can be used for animal experiments in animals of different body sizes, and can also be used in a variety of different animal experiments.

[0046] Please continue reading. Figure 2To ensure the strength of the connection between the rhombus structures 111, in a specific embodiment of the present invention, the number of winding wires 112 is two. One winding wire 112 starts from the near end of any rhombus structure 111 within the wave loop 11 and winds around the edge of the rhombus structure 111 until it winds to the middle part of this edge. Then, it extends out of the rhombus structure 111 from the middle part and enters the adjacent rhombus structure 111, starting from the middle part of the adjacent rhombus structure 111 and winding towards the far end. After winding to the far end of the adjacent rhombus structure 111, it winds again from the far end towards the middle part, and then extends from the middle part into the next rhombus structure 111, and so on, winding in a wavy line until all the rhombus structures 111 are wound. Another winding wire 112 begins winding from the distal end of the first rhombus structure 111 to the middle portion, and extends beyond the rhombus structure 111 from the middle portion. It then intertwines with the winding wire 112 and enters the adjacent rhombus structure 111, starting from the middle portion of the adjacent rhombus structure 111 and winding towards the proximal end. After winding to the distal end of the adjacent rhombus structure 111, it winds again from the distal end towards the middle portion, extends from the middle portion, intertwines with the winding wire 112, and enters the next rhombus structure 111, and so on, in a wavy pattern until all rhombus structures 111 are wound. That is, adjacent rhombus structures 111 are connected by the two winding wires 112 intertwining with each other. By adopting the above-described configuration, the overall connection strength of the wave coil 11 can be ensured, preventing the winding wire 112 from breaking during the expansion of the support 100. Furthermore, using the winding wire 112 to connect the rhomboid structures 111 ensures that the winding wire 112, due to its good flexibility, is less prone to breakage compared to rigid connectors. Even if one winding wire 112 breaks, the other winding wire 112 will still provide a connection. Additionally, this configuration prevents multiple rhomboid structures 111 from crowding and compressing each other during the expansion of the support 100, thus avoiding uneven expansion of the wave coil 11.

[0047] In other specific embodiments of the present invention, the number of the winding wire 112 may also be one, and the one winding wire 112 is wound in a wave shape around all the rhomboid structures 111 within the wave loop 11.

[0048] Please continue reading. Figure 2In a specific embodiment of the present invention, a plurality of rhomboid structures 111 of a wave loop 11 are staggered with a plurality of rhomboid structures 111 of an adjacent wave loop 11; and the central axis of the rhomboid structure 111 of a wave loop 11 is collinear with the centerline between two adjacent rhomboid structures 111 on an adjacent wave loop 11, such as... Figure 4 As shown. Through the above-described design, the anchoring force of the stent 100 can be improved, preventing displacement of the stent 100 after being impacted by blood flow within the blood vessel. Simultaneously, it ensures the seal of the stent 100 after expansion within the blood vessel, preventing blood from passing between the vessel wall and the outer wall of the stent 100, thereby preventing thrombus formation between the vessel wall and the outer wall of the stent 100.

[0049] In other specific embodiments of the present invention, a plurality of rhomboid structures 111 of one wave loop 11 may be arranged in a one-to-one correspondence with a plurality of rhomboid structures 111 of an adjacent wave loop 11.

[0050] Furthermore, the stent 100 also includes a filling portion 13 with a cavity, the filling portion 13 being disposed on the outer surface of the covering membrane 12, and the cavity of the filling portion 13 containing a filling fluid (not shown). The filling fluid can be a medical gel, saline solution, etc., or a contrast agent can be injected into the filling portion 13 as a filling fluid, thereby giving the filling portion 13 an imaging effect. For some embodiments of the present invention, please refer to... Figure 6 The filling portion 13 is multiple in number and has a ring-shaped structure. The filling portion 13 is disposed between every two adjacent wave loops 11, that is, within the spacing between two adjacent wave loops 11. The filling portion 13 further hinders the transmission of force between two adjacent wave loops 11, further ensuring that when the stent 100 is subjected to uneven expansion, the mutual influence between adjacent wave loops 11 is minimized, thereby preventing the stent 100 from shortening or shifting. Simultaneously, the filling portion 13 can also fill the gap between the covering 12 and the blood vessel wall. For example, when the stent 100 expands in a relatively tortuous blood vessel, the stent 100 may not be able to completely adhere to the blood vessel wall, resulting in a gap between the stent 100 and the blood vessel wall. The filling portion 13, located on the outer surface of the covering 12, can fill the gap, further improving the sealing performance of the stent and preventing blood from entering the gap and causing stent displacement or thrombosis. The filling part 13 can be made of flexible materials such as polyester, PET, and PTFE to ensure that the filling part 13 can deform accordingly as the stent 100 expands. At the same time, the flexible filling part 13, in conjunction with the filling fluid, ensures that the filling part 13 will not damage the blood vessel wall when it comes into contact with it.

[0051] It should be noted that when the stent 100 is not expanded, the cavity of the filling part 13 should not be completely filled with the filling liquid. Figure 7 As shown, this ensures that after the support 100 expands, the filling fluid will not rupture the filling portion 13 due to compression. Preferably, the filling fluid completely fills the cavity of the filling portion 13 after expansion, such as... Figure 8 As shown, this ensures the support force of the filling part 13.

[0052] In other specific embodiments of the present invention, if the filling part 13 only needs to serve a sealing function, one filling part 13 can be provided at the proximal end and one at the distal end of the stent 100, and the filling part 13 can be omitted in the remaining parts, as shown in Figure 9. By sealing the end of the stent 100, blood can be prevented from entering the gap between the stent 100 and the blood vessel wall.

[0053] Please see Figure 10 In some embodiments of the present invention, the number of filling portions 13 is multiple, and the filling portions 13 have a linear structure. Multiple filling portions 13 are disposed between every two adjacent rhombic structures 111 of each wave coil 11, and the length direction of the filling portion 13 is consistent with the length direction of the rhombic structure 111. Firstly, the filling portion 13 can increase the anchoring force of the support 100. Secondly, the presence of the filling portion 13 in every two adjacent rhombic structures 111 can delay, reduce, or hinder the force transmission between adjacent rhombic structures 111, thus buffering the force of a single wave coil 11 during expansion to the filling portion 13, reducing the force transmitted by the wave coil 11 to adjacent wave coils 11 during expansion. This further prevents the support 100 from being deformed when subjected to uneven expansion, as a single rhombic structure 111 may experience greater force, causing deformation of the remaining rhombic structures 111, thereby preventing the support 100 from being molded into a bent shape during expansion. To further ensure that the support 100 is subjected to uneven expansion, the mutual influence between adjacent wave coils 11 is minimized, thereby preventing shortening or displacement of the support 100. Furthermore, the annular filling portion 13 can be disposed between two adjacent wave coils 11 to further reduce the mutual influence between adjacent wave coils 11. The linear filling portion 13 can also be connected to the cavity of the annular filling portion 13, thereby forming a mesh structure on the outer surface of the support 100, such as... Figure 11As shown. Through the above design, the deformation of the remaining rhomboid structures 111 due to excessive force on a single rhomboid structure 111 is minimized, thus preventing the stent 100 from being molded into a bent shape during expansion. It also reduces the mutual influence between adjacent wave coils 11, thereby avoiding a combination of shortening and displacement of the stent 100. In other words, the stent 100 is minimized from being molded into a bent shape during expansion, and shortening and displacement are also avoided. Simultaneously, since the annular filling portion and the linear filling portion together constitute the mesh structure of the filling portion 13, and it is disposed on the outer surface of the stent 100, the filling fluid can flow within the cavities of the annular filling portion and the linear filling portion, that is, the filling fluid can flow within the cavities of the mesh structure filling portion 13. Therefore, when the stent 100 expands and supports itself within an irregular or highly tortuous blood vessel, the filling fluid can flow adaptively according to the actual situation. For example, in locations where the gap between the stent 100 and the blood vessel wall is small, only a small amount of the filling fluid is needed. Excess filling fluid can flow to locations where the gap between the stent 100 and the blood vessel wall is larger, thereby filling the larger gap. This ensures the overall support performance, anchoring performance, and sealing performance of the stent 100.

[0054] In other specific embodiments of the present invention, when a plurality of rhomboid structures 111 of one wave loop 11 are arranged in a one-to-one correspondence with a plurality of rhomboid structures 111 of adjacent wave loops 11, the filling portion 13 of the mesh structure may also be provided, such as... Figure 12 As shown. This overcomes the drawback of poor sealing performance when multiple rhomboid structures 111 of a wave coil 11 are arranged in a one-to-one correspondence with multiple rhomboid structures 111 of adjacent wave coils 11.

[0055] Further, please refer to Figure 9 and Figure 13When the end of the balloon is inflated first, causing the corrugated coil 11 at the end of the stent 100 to expand first, the stent 100 will move towards the other end due to the force applied to its end first. Therefore, in some embodiments of the present invention, the corrugated coils 11 at the proximal and distal ends of the stent 100 can be set separately. That is, the proximal and distal ends of the stent 100 include end corrugated coils 14, which include a first corrugated coil 141 and a second corrugated coil 142, which are spaced apart, and the filling part 13 is disposed between the first corrugated coil 141 and the second corrugated coil 142. The end corrugations 14 are configured as two separate, non-connected first corrugations 141 and second corrugations 142. This allows some of the force during expansion of the end corrugations 14 to be buffered within the gap between the first corrugations 141 and second corrugations 142, preventing one end of the end corrugation 14 from expanding first and causing the support 100 to move towards the other end. The filling portion 13 located between the first corrugations 141 and second corrugations 142 ensures the sealing of the end of the support 100.

[0056] Please see Figure 14 and Figure 15 A second embodiment of the present invention provides a stent system 200, which includes the stent 100 of the first embodiment and a balloon catheter assembly 2. The balloon catheter assembly 2 includes a catheter 21, a balloon 22, and a filter 23. The balloon 22 and the filter 23 are disposed on the distal end of the catheter 21, and the filter 23 is disposed on the proximal side of the balloon 22, that is, the filter 23 is closer to the proximal end than the balloon 22. In use, the stent 100 is fitted onto the balloon 22, and the stent 100 is expanded by inflating the balloon 22, so that the stent 100 expands and anchors in the blood vessel. The filter 23 includes multiple filter filaments 231, which are spaced apart circumferentially. The distal ends of the filter filaments 231 are free ends, and the proximal ends gradually approach each other and are fixed within a fixing ring 232. The fixing ring 232 is sleeved on the guide tube 21, thereby placing the filter on the guide tube 21. The filter 23 is made of shape memory alloy material, meaning that the filter 23 can deform under external force and return to its original shape after the external force is removed.

[0057] In use, the support 100, the balloon 22, and the filter 23 are loaded inside the sheath 3, as follows: Figure 15As shown. The balloon catheter assembly 2 and the sheath 3 are inserted into the blood vessel and reach the lesion site. The balloon 22 and the stent 100 are then aligned with the lesion site, and the sheath 3 is withdrawn proximally, releasing the balloon 22 and the filter 23. At this point, the filter 23 deploys and anchors within the blood vessel, thus providing initial fixation for the balloon catheter assembly 2. Subsequently, the balloon 22 is inflated, causing it to expand and expand the stent 100, thereby anchoring the stent 100 within the blood vessel. Figure 16 As shown. The filter 23 can collect thrombi and other substances in the blood vessels, preventing them from causing blockages. After the stent 100 expands into the blood vessel, the balloon 22 can be depressurized, and the sheath 3 can be moved towards the distal end, thereby sequentially retracting the filter 23 and the balloon 22 into the sheath 3, and then withdrawing the balloon catheter assembly 2 and the sheath 3 out of the body.

[0058] Further, please refer to Figure 17 -19, the filter wire 231 has barbs 2311 on its outer surface away from the catheter 21. The barbs 2311 extend distally, ensuring that the barbs 2311 do not interfere with the sheath 3 when the sheath 3 moves distally to retract the filter 23 into the sheath 3, thus ensuring that the filter 23 can be smoothly retracted into the sheath 3. In a specific embodiment of the present invention, the filling portion 13 of the stent 100 can be filled with medication, and the filter 23 can be deployed within the stent 100. The barbs 2311 pierce into the filling portion 13, thereby releasing the medication within the filling portion 13 onto the diseased blood vessel wall, giving the stent 100 the function of a drug-eluting stent. Specifically, after the stent 100 has expanded and anchored in the blood vessel, the balloon 22 is depressurized, and the sheath 3 is moved distally to retract the filter 23 into the sheath 3, as shown. Figure 17 As shown. The balloon catheter assembly 2 and the sheath 3 are then moved distally until the filter 23 is within the support 100. The sheath 3 is then withdrawn proximally, releasing the filter 23 within the support 100, thereby allowing the barbs 2311 to penetrate the inner and outer surfaces of the filling portion 13, as shown. Figure 18 , 19 As shown. The filter 23 is then retrieved into the sheath 3, and the balloon catheter assembly 2 and the sheath 3 are moved proximally, allowing the balloon 22 to move into the stent 100. The balloon 22 is then inflated, causing it to adhere tightly to the inner surface of the stent 100, allowing the medication within the filling portion 13 to flow out from the outer surface and penetrate into the blood vessel wall, thereby treating the vascular lesion area.

[0059] It should be noted that the stent system 200 of the second embodiment of the present invention is also applicable to animal blood vessels. For example, after animal experiments are completed, if there are other research attempts, or if the experimental animals are to be kept alive for other uses, the stent 100 can also be released into the animal's blood vessel through the stent system 200 to save the animal. For example, after performing a stoma experiment on an animal's blood vessel, the stent 100 can be released into the gap in the animal's blood vessel. Alternatively, medical adhesive can be filled into the filling portion 13 of the stent 100, and then, through the above process, the medical adhesive in the filling portion 13 can be used to fill the gap in the animal's blood vessel, thereby saving the animal.

[0060] Compared with existing technologies, the stent and stent system of the present invention have the following advantages: Firstly, the main body of the coils in the present invention adopts a rhomboid structure, ensuring the overall support, extensibility, and expandability of the stent. Simultaneously, the rhomboid structure has better wall-adhering performance, preventing blood leakage. Secondly, multiple coils are spaced apart from each other, and there are no connecting parts between them. This minimizes the mutual influence between adjacent coils during uneven expansion, reducing the force transmission between adjacent coils and preventing displacement, shortening, or slippage from the balloon due to uneven force during expansion. Furthermore, the stent uses multiple rhomboid structures individually arranged, and these structures are connected by the winding wire to maximize the freedom of each individual rhomboid structure. When a single rhomboid structure is under stress, the force transmission to adjacent rhomboid structures is minimized. This prevents a single rhomboid structure from experiencing excessive force during uneven balloon inflation, which could cause deformation of the remaining rhomboid structures and prevent the stent from being molded into a bent shape during expansion. Meanwhile, connecting multiple rhomboid structures through the winding wire can improve the overall adaptability of the stent, so that even if the stent rotates, bends or shortens, it can adapt to the above situations and ensure the medical effect of the stent.

[0061] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A stent for interventional treatment of vascular lesions, characterized in that: The support includes a membrane and multiple corrugated coils. In its natural state, the multiple corrugated coils are spaced apart from each other along the axial direction of the membrane. Each corrugated coil includes multiple rhomboid structures and winding wires, which are wound around the multiple rhomboid structures to connect them.

2. The bracket as described in claim 1, characterized in that: The rhombus structure has a proximal end and a distal end. There are two winding wires. One winding wire starts from the proximal end of one rhombus structure and winds to the middle part, then extends out of the middle part of the rhombus structure and enters the other rhombus structure. It then winds from the middle part of the other rhombus structure toward the distal end. The other winding wire starts from the distal end of one rhombus structure and winds to the middle part, then extends out of the middle part of the rhombus structure. It intertwines with the first winding wire and enters the other rhombus structure. It then winds from the middle part of the other rhombus structure toward the proximal end.

3. The bracket as described in claim 1, characterized in that: The plurality of rhomboid structures of one wave loop are staggered with the plurality of rhomboid structures of adjacent wave loops; and the central axis of the rhomboid structure of one wave loop is collinear with the centerline between two adjacent rhomboid structures on the adjacent wave loop.

4. The bracket as described in claim 1, characterized in that: The plurality of rhomboid structures of one wave loop are arranged in a one-to-one correspondence with the plurality of rhomboid structures of adjacent wave loops.

5. The bracket as described in claim 1, characterized in that: The wave coil is woven from metal wire, or the rhomboid structure is cut from a metal tube. The winding wire is made of metal wire. The proximal and distal ends of the rhomboid structure include arc-shaped structures and / or linear structures. The spacing between two adjacent wave coils is 0.2mm-0.6mm.

6. The stent as described in claim 3 or 4, characterized in that: The support also includes a filling portion having a cavity, the filling portion being disposed on the outer surface of the membrane, and the cavity of the filling portion being filled with a filling liquid.

7. The bracket as described in claim 6, characterized in that: The end of the bracket includes an end corrugated ring, which includes a first corrugated ring and a second corrugated ring. The first corrugated ring and the second corrugated ring are spaced apart, and the filling portion is disposed between the first corrugated ring and the second corrugated ring.

8. The stent as described in claim 6, characterized in that: The filling part has a ring structure and is disposed between two adjacent wave loops.

9. The bracket as described in claim 6, characterized in that: The number of filling portions is multiple, and the filling portions have a linear structure. The multiple filling portions are disposed between every two adjacent diamond structures of each wave loop.

10. The stent as described in claim 6, characterized in that: The filling portion includes multiple annular filling portions and linear filling portions. The annular filling portions are disposed between two adjacent wave loops, and the multiple linear filling portions are disposed between every two adjacent rhomboid structures of each wave loop. The multiple annular filling portions and linear filling portions are interconnected.

11. A support system, characterized in that: The stent system includes a stent as described in any one of claims 1-10, and the stent system further includes a balloon catheter assembly, the balloon catheter assembly including a catheter, a balloon and a filter, the balloon being disposed at the distal end of the catheter, and the filter being disposed at the distal end of the catheter and proximal to the balloon.

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