Neurointerventional stent system

Abstract

The application discloses a kind of neurointerventional stent systems, belong to medical instrument technical field, including sheath, stent and guide structure, stent movably set in sheath;Guide structure includes guide body and release part, guide body movably passes in sheath and stent;Release part movably passes in sheath, release part includes first bending section and second bending section, first bending section is connected with the one end of guide body along length direction, first bending section is curved and extends setting in the direction of first bending section away from guide body then close to guide body;Second bending section is connected to the one end of first bending section away from guide body, the one end of second bending section away from first bending section is curved and extends setting towards the direction of second bending section close to guide body.The part of guide structure release in blood vessel forms U shape or back shape bend, avoid the tip of release part and blood vessel wall abut, avoid damaging blood vessel when releasing stent, can adjust stent release position in time without damaging blood vessel.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, specifically relating to a neurointerventional stent system. Background Technology

[0002] Neurointerventional techniques primarily involve inserting stents into blood vessels to open them and restore blood flow. During stent placement, a guiding structure is used to push and position the stent. However, during stent deployment, the tip of the guiding structure is first released into the blood vessel, followed by the stent itself. But during deployment, as the guiding structure continues to push the stent into the vessel, if the distance is too long, it can easily become C-shaped within the vessel, potentially causing damage to the vessel wall, vessel rupture, or stent deployment failure. Utility Model Content

[0003] Purpose of the utility model: This application provides a neurointerventional stent system, which aims to solve the problem that the guide structure is prone to C-shaped bending during the existing stent release process, which can lead to damage to the blood vessel wall, blood vessel rupture, or stent release failure.

[0004] Technical solution: A neurointerventional stent system according to an embodiment of this application includes a sheath, a stent, and a guiding structure, wherein the stent is movably disposed within the sheath;

[0005] The guiding structure includes:

[0006] The guiding body is movably inserted into the sheath and the support;

[0007] A release section is movably inserted inside the sheath. The release section includes a first bent section and a second bent section. The first bent section is connected to one end of the guide body along its length and extends in a direction that first moves away from the guide body and then moves closer to the guide body. The second bent section is connected to the end of the first bent section that moves away from the guide body and extends in a direction that moves closer to the guide body.

[0008] In some embodiments, when the release portion protrudes into the blood vessel, the portion of the second bend segment near the first bend segment abuts against the inner wall of the blood vessel, and the end of the second bend segment away from the first bend segment is spaced apart from the inner wall of the blood vessel.

[0009] In some embodiments, the second bending segment is spaced apart from the guide body, and the centerline of the second bending segment is coplanar with the centerline of the guide body.

[0010] In some embodiments, the first bending segment and the second bending segment are pre-shaped arc segments.

[0011] In some embodiments, when the release portion is located inside the sheath, the central angle of the first bend is α, and the central angle of the second bend is β, satisfying: α > β.

[0012] In some embodiments, α and β satisfy: α + β > 180°.

[0013] In some embodiments, the outer surface of the guide structure is a smooth arc surface.

[0014] In some embodiments, the outer surface of the sheath and / or the outer surface of the guide structure is coated with a super-slippery coating, the super-slippery coating comprising a fluoropolymer or a hydrophilic hydrogel material, the thickness of the super-slippery coating being 0.01 mm to 0.02 mm.

[0015] In some embodiments, the distal ends of the sheath are provided with opposite protrusions, and the outer surfaces of the protrusions are arc-shaped.

[0016] In some embodiments, a developer is uniformly distributed within the protrusion, and the developer is at least one of tantalum, platinum, platinum alloy, gold, tungsten, iodine-containing compounds, and barium.

[0017] In some embodiments, the outer surface of the support is coated with a developing coating, the developing coating comprising at least one of tantalum, platinum, platinum alloy, gold, tungsten, iodine-containing compounds, and barium.

[0018] In some embodiments, the sheath includes:

[0019] Main body paragraph;

[0020] A folded section is connected to the distal end of the main body section, and the guide body is movably inserted into the main body section and the folded section;

[0021] The head section is connected to the end of the reverse fold section away from the main body section. The bracket is movably disposed within the head section. The guide body is movably disposed within the bracket and the head section. The release part is movably disposed within the head section and is located at the end of the bracket away from the reverse fold section.

[0022] In some embodiments, the sheath comprises a polyimide wall with a thickness of 0.15 mm to 0.2 mm.

[0023] In some embodiments, the sheath includes a polyimide fiber layer, a polyester fiber layer, and a polyurethane fiber layer stacked from the inside out, wherein the thickness of the polyimide fiber layer is 0.08 mm to 0.1 mm, the thickness of the polyester fiber layer is 0.1 mm to 0.12 mm, and the thickness of the polyurethane fiber layer is 0.08 mm to 0.1 mm.

[0024] In some embodiments, the outer diameter of the head segment gradually decreases in the direction away from the folded segment.

[0025] In some embodiments, the sheath further includes a reinforcing layer embedded in the wall of the folded section, the reinforcing layer being a coiled metal wire with a coiling spacing of 0.5 mm to 0.6 mm.

[0026] In some embodiments, the guiding structure is a microwire or a microcatheter.

[0027] Beneficial Effects: Compared with the prior art, the neurointerventional stent system of this application includes a sheath, a stent, and a guiding structure. The stent is movably disposed within the sheath. The guiding structure includes a guiding body and a release part. The guiding body is movably disposed within the sheath and the stent. The release part is movably disposed within the sheath and includes a first bending segment and a second bending segment. The first bending segment is connected to one end of the guiding body along its length and extends in a direction that first moves away from the guiding body and then towards it. The second bending segment is connected to the end of the first bending segment away from the guiding body and extends in a direction that moves towards the guiding body. The guiding body of the guiding structure of this application is used to fix and push the stent. The release part is used to abut against the blood vessel wall after the guiding structure enters the blood vessel, so that the part of the guiding structure released into the blood vessel forms a U-shape or a U-shaped bend, avoiding the tip of the release part from abutting against the blood vessel wall, thereby effectively protecting the blood vessel and facilitating successful stent release. At the same time, it can adjust the stent release position in time without damaging the blood vessel if the position is not suitable. Attached Figure Description

[0028] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0029] Figure 1 This is a cross-sectional view of the overall structure of a neurointerventional stent system according to an embodiment of this application;

[0030] Figure 2 This is a schematic diagram of the structure of a neurointerventional stent system according to an embodiment of this application when the guiding structure is located inside the sheath;

[0031] Figure 3 This is a cross-sectional view of the release section of a neurointerventional stent system according to an embodiment of this application after it has entered a blood vessel;

[0032] Figure 4 This is a schematic diagram of the structure of a stent in a neurointerventional stent system according to an embodiment of this application;

[0033] Figure 5 This is a schematic diagram of the stent release process of a neurointerventional stent system according to an embodiment of this application;

[0034] Figure 6 This is a schematic diagram of the sheath of a neurointerventional stent system according to an embodiment of this application;

[0035] Figure 7 This is a cross-sectional view of a sheath of a neurointerventional stent system according to an embodiment of this application;

[0036] Figure 8 This is a cross-sectional view of another sheath of a neurointerventional stent system according to an embodiment of this application.

[0037] Explanation of reference numerals in the attached figures:

[0038] 100. Sheath; 110. Convex portion; 120. Main body section; 130. Reverse fold section; 140. Head section; 150. Polyimide tube wall; 160. Polyimide fiber layer; 170. Polyester fiber layer; 180. Polyurethane fiber layer; 190. Reinforcing layer;

[0039] 200. Bracket;

[0040] 300. Guiding structure; 310. Guiding body; 320. Release section; 321. First bending section; 322. Second bending section;

[0041] 400, Super Smooth Coating;

[0042] 500. Blood vessels. Detailed Implementation

[0043] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this application without creative effort are within the scope of protection of this application.

[0044] In the description of this application, it should be understood that the terms "proximal" and "distal" are used with the surgeon (physician) as the reference point. "Proximal" refers to the end of the surgical instrument closer to the surgeon, while "distal" refers to the end further away from the surgeon relative to the "proximal," i.e., closer to the patient. It should also be understood that the terms "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "top," "bottom," "inner," and "outer," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more features. In the description of this application, "multiple" means two or more, and "at least one" means one, two, or more, unless otherwise explicitly specified. In the description of this application, "perpendicular" means completely perpendicular to 90° or almost completely perpendicular, for example, an angle of 80° to 100° is considered perpendicular. Similarly, "parallel" means completely parallel or almost completely parallel, for example, a completely parallel angle of 10° is considered parallel.

[0045] Transvascular neurointerventional therapies are rapidly developing. One approach involves placing a stent at the lesion site within a blood vessel to open it and maintain blood flow. However, during stent deployment, the stent deployment guidewire is prone to C-shaped bends, causing the tip to come into contact with the vessel wall, potentially leading to vessel wall damage or even perforation. Furthermore, the stent's placement cannot be adjusted, increasing the risk of deployment failure.

[0046] In view of this, embodiments of this application provide a neurointerventional stent system, which aims to solve the above-mentioned problems.

[0047] like Figure 1 and Figure 2As shown, this application provides a neurointerventional stent system, which includes a sheath 100, a stent 200, and a guide structure 300. The stent 200 is movably disposed within the sheath 100. The guide structure 300 includes a guide body 310 and a release part 320. The guide body 310 is movably disposed within the sheath 100 and the stent 200. The release part 320 is connected to the distal end of the guide body 310 and is movably disposed within the sheath 100. The release part 320 includes a first bent section 321 and a second bent section 322. The first bent section 321 is connected to one end of the guide body 310 along its length and extends in a direction that first moves away from the guide body 310 and then moves closer to the guide body 310. The second bent section 322 is connected to the end of the first bent section 321 that is away from the guide body 310 and extends in a direction that moves closer to the guide body 310.

[0048] In this embodiment, the guide body 310 of the guide structure 300 is used to fix and push the stent 200, and the release part 320 is used to abut against the wall of the blood vessel 500 after the guide structure 300 enters the blood vessel 500, so that the part of the guide structure 300 released into the blood vessel 500 forms a U-shape or a U-shape bend, avoiding the tip of the release part 320 from abutting against the wall of the blood vessel 500, thereby effectively protecting the blood vessel 500, which is conducive to the successful release of the stent 200. At the same time, if the position is not suitable, the release position of the stent 200 can be adjusted in time without damaging the blood vessel 500.

[0049] like Figure 3 and Figure 5 As shown, specifically in this embodiment, the sheath 100 is used to accommodate the stent 200 and the guiding mechanism. During neurointervention, the sheath 100 is gradually inserted into the blood vessel 500 and eventually reaches the expected position to deliver the stent 200 to the corresponding location. Then, the sheath 100 is fixed, and the guiding mechanism is continued to be pushed into the blood vessel 500, gradually pushing the stent 200 into the blood vessel 500. During the release of the stent 200, the release part 320 of the guiding mechanism is first released into the blood vessel 500, and part of the outer wall of the release part 320 abuts against the inner wall of the blood vessel 500, thereby achieving the positioning of the release position. Then, the guiding body 310 is continued to be pushed, and the guiding body 310 pushes the stent 200 out of the sheath 100. The blood vessel 500 gradually opens because it is no longer restrained by the sheath 100, until the stent 200 is completely inserted into the blood vessel 500, realizing the release of the stent 200.

[0050] In this embodiment, by combining the first bending segment 321 and the second bending segment 322 to form the release part 320, a stepped buffer bend can be formed, which makes it easy to change the bending degree and extension size of the overall release part 320. This can overcome the risk of damage to the inner wall of the blood vessel 500 caused by the guide structure 300 rebounding and deforming due to the loss of some constraint force when it is released from the small space inside the sheath 100 into the relatively large space of the blood vessel 500.

[0051] Specifically, when the release section 320 is released into the blood vessel 500, the first bent segment 321 partially rebounds, causing the central angle to increase. At this time, the end of the first bent segment 321 away from the guide body 310 deforms towards the inner wall of the blood vessel 500, while the second bent segment 322 connects to the end of the first bent segment 321 away from the guide body 310. This prevents the end of the first bent segment 321 away from the guide body from directly piercing into the inner wall of the blood vessel 500. Simultaneously, the deformation of the first bent segment 321 causes the second bent segment 322 to move towards the inner wall of the blood vessel 500 until the outer wall of the second bent segment 322 abuts against the inner wall of the blood vessel 500, thereby fixing the release point. During this process, the release part 320 has a smooth outer wall that abuts against the inner wall of the blood vessel 500. Since the end of the second bending segment 322 away from the first bending segment 321 bends and extends toward the guide body 310, the end of the second bending segment 322 away from the first bending segment 321 will not pierce the wall of the blood vessel 500, thereby effectively ensuring the safety of the blood vessel 500 and thus helping to improve the success rate of stent 200 placement.

[0052] It is understandable that the connection between the first bending segment 321 and the second bending segment 322 forms an arc transition, which effectively eliminates the hard inflection point at the connection point. This can prevent the sharp inflection point from directly contacting the inner wall of the blood vessel 500 after the release part 320 enters the blood vessel 500, thereby further effectively protecting the blood vessel 500 and avoiding damage to the blood vessel 500.

[0053] It should be noted that since the outer wall of the release section 320 contacts the inner wall of the blood vessel 500, if the stent 200 is not positioned correctly, the position can be adjusted directly by adjusting the position of the direct system. By continuing to push or pull out the sheath 100, the release section 320 of the corresponding pushing or pulling guide structure 300 moves within a small range within the blood vessel 500. Since the second bending segment 322 is in smooth contact with the inner wall of the blood vessel 500, the movement of the second bending segment 322 will not damage the wall of the blood vessel 500, thereby improving the success rate and positioning accuracy of stent 200 placement without damaging the blood vessel 500.

[0054] It should also be noted that the second bend 322 makes smooth contact with the inner wall of the blood vessel 500, which can effectively disperse local pressure and reduce the risk of damage or spasm of the inner wall of the blood vessel 500 caused by single-point compression.

[0055] In some embodiments, during the release of the stent 200 within the blood vessel 500, the release portion 320 extends through the blood vessel 500, and the portion of the second bent section 322 near the first bent section 321 abuts against the inner wall of the blood vessel 500, while the end of the second bent section 322 away from the first bent section 321 is spaced apart from the inner wall of the blood vessel 500.

[0056] Neurointerventions often involve cerebral blood vessels 500, which are often thin and have fragile walls. Contact with the guidewire tip can easily lead to serious complications such as rupture, dissection, or hemorrhage of the blood vessel 500. The guiding structure 300 of this embodiment addresses this by providing a release section 320. The first bend 321 of the release section 320 springs back into a C-shape, and the second bend 322 abuts against the inner wall of the blood vessel 500. The second bend 322 is spaced away from the tip of the first bend 321 from the inner wall of the blood vessel 500. In this configuration, only a portion of the release section 320 abuts against the inner wall of the blood vessel 500, preventing the tip of the release section 320 from contacting or abutting against the blood vessel wall. This effectively avoids the risk of tip damage to the inner wall of the blood vessel 500, providing effective protection for the blood vessel 500 and facilitating the smooth placement of the stent 200. Meanwhile, the U-shaped or loop-shaped bend formed by partial contact can disperse pressure through the arc-shaped contact surface, reducing the pressure damage to the local vascular wall. It is especially suitable for damaged vascular walls near lesion sites (such as stenosis or calcification), significantly reducing the risk of intraoperative vascular complications.

[0057] It should also be noted that, in traditional methods, during stent 200 deployment, the guidewire, due to its extensive insertion into the blood vessel 500, easily forms a C-shaped bend within the vessel 500. At this point, the guidewire tip abuts against the inner wall of the vessel 500, potentially causing jamming. This makes it difficult to flexibly adjust the position of the stent 200 system, leading to inability to adjust the stent 200 deployment position and ultimately resulting in deployment failure. In this embodiment, however, the distal end of the deployment section 320, i.e., the end of the second bend 322 furthest from the first bend 321, is spaced from the inner wall of the blood vessel 500, and the U-shaped or loop-shaped bend provides ample room for movement in the guiding structure 300. When the stent 200 position needs adjustment, the guiding body 310 can slightly slide the deployment section 320 within the blood vessel 500. The partial contact between the deployment section 320 and the vessel 500 wall provides necessary support and stability while avoiding rigid jamming. This allows the surgeon to precisely control the stent 200 deployment position by fine-tuning the guiding structure 300, significantly improving the surgical success rate.

[0058] Therefore, it should also be noted that the stent 200 system implemented in this application is applicable not only to arterial vessels 500, but also to relatively thinner venous vessels 500.

[0059] It should also be noted that the design of the second bending section 322 of the release part 320 abutting against the inner wall of the blood vessel 500 and the U-shaped or spiral bend formed between the release part 320 and the guide body 310 after release allows the release part 320 to form a flexible fit with the inner wall of the blood vessel 500. This provides a stable support point for the guide structure 300 during the push of the stent 200, reducing the shaking or displacement of the guide structure 300 caused by the pulsation of the blood vessel 500 and the impact of blood flow. This ensures that the stent 200 can always unfold along the preset path during the release process, effectively reducing the risk of poor stent wall adhesion, displacement or twisting, and further improving the controllability and effectiveness of stent 200 release.

[0060] It should also be noted that the blood vessels 500 in neurointerventions often have complex shapes such as tortuosity, stenosis, and bifurcation. Traditional guidewires are prone to forming sharp angles of contact in complex blood vessels 500, which increases the operating resistance and the risk of damage to the blood vessel 500. However, the guide structure 300 of this application embodiment forms a U-shape or spiral bend after release, which can better conform to the natural curvature of the blood vessel 500. This allows it to better follow the extension path of the blood vessel 500, reduce the mechanical friction between the guide structure 300 and the inner wall of the blood vessel 500, and thus reduce the difficulty for the surgeon to push and adjust the guide structure 300.

[0061] like Figure 2 As shown, in some embodiments, the second bending segment 322 is spaced apart from the guide body 310, and the center line of the second bending segment 322 is coplanar with the center line of the guide body 310.

[0062] In this embodiment, the second bending segment 322 and the guide body 310 are spaced apart to avoid interference between them and ensure the freedom of movement of the release part 320. Simultaneously, the centerline of the second bending segment 322 is coplanar with the centerline of the guide body 310, forming a planar curved overall shape between the double-bending structure of the release part 320 and the guide body 310, rather than an irregular bend diverging in any direction in three-dimensional space. This coplanar characteristic ensures that the bending direction of the second bending segment 322 is always in the same plane as the extension path of the guide body 310, preventing the release part 320 from tilting or twisting due to spatial offset. This ensures that the end of the second bending segment 322 furthest from the first bending segment 321 always extends towards the guide body 310, thereby stably maintaining a gap between the end of the second bending segment 322 furthest from the first bending segment 321 and the inner wall of the blood vessel 500. This effectively reduces the risk of accidental contact between the end of the second bend 322 of the release section 322, which is away from the first bend 321, and the inner wall of the blood vessel 500 due to posture disorder, further reducing the risk of damage to the inner wall of the blood vessel 500.

[0063] In some embodiments, the first bending segment 321 and the second bending segment 322 are pre-shaped arc segments.

[0064] In this embodiment of the application, the first bending segment 321 and the second bending segment 322 are pre-shaped during the preparation of the guide structure 300, so that both are pre-shaped into arc segments (the arc bending angles can be different). At this time, the outer surfaces of the two form smooth curved surfaces, which can effectively avoid possible broken lines or sharp angle structures, thereby effectively eliminating hard inflection points and further improving the protection effect on the inner wall of the blood vessel 500.

[0065] It should be noted that by pre-shaping the first bending segment 321 and the second bending segment 322, the pre-shaping shape can be maintained after the release part 320 is released. During the release of the stent 200, the bending direction of the first bending segment 321 and the second bending segment 322 can be maintained, which is conducive to guiding the main body 310 to gradually enter the blood vessel 500 and forming a similar loop-shaped structure with the release part 320, thereby achieving effective protection of the blood vessel 500.

[0066] like Figure 2 As shown, in some embodiments, when the release part 320 is located inside the sheath 100, the central angle of the first bending segment 321 is α, and the central angle of the second bending segment 322 is β, satisfying: α > β.

[0067] In this embodiment, since the sheath 100 needs to match the inner diameter of the blood vessel 500 in the neurointervention, the inner and outer diameters of the sheath 100 are relatively small. When the release part 320 is inside the sheath 100, the first bending segment 321 undertakes the main morphological contraction task with a larger bending amplitude, while the second bending segment 322 maintains a relatively convergent state with a relatively small central angle. At this time, it can effectively avoid the first bending segment 321 and the second bending segment 322 from being squeezed or entangled in a limited space, thereby reducing the material or morphological distortion caused by their mutual resistance.

[0068] Understandably, due to the larger central angle of the first bending segment 321, it has greater potential for expansion after being released from the sheath 100, thus quickly pushing the second bending segment 322 to the inner wall of the blood vessel 500, achieving contact between the second bending segment 322 and the inside of the blood vessel 500. Simultaneously, the combination of the first bending segment 321 and the second bending segment 322 allows the second bending segment 322 to disperse and buffer the expansion support force of the first bending segment 321, thereby reducing the impact on the inner wall of the blood vessel 500 upon release of the release part 320, further improving the safety of the inner wall of the blood vessel 500.

[0069] Furthermore, in some embodiments, α and β satisfy: α + β > 180°.

[0070] In this embodiment, the total bending angle of the first bending segment 321 and the second bending segment 322 exceeds a horizontal angle. This provides sufficient elastic potential energy to allow the release portion 320 to fully extend after release. When the release portion 320 exits the sheath 100, the two bends unfold under the action of elastic restoring force. The initial reserve of a total bending center angle exceeding 180° ensures that it ultimately forms a U-shaped or loop-shaped bend as designed. This effectively protects the inner wall of the blood vessel 500.

[0071] Furthermore, the large angle α of the first bending segment 321 can provide the basic bending arc, and the β of the second bending segment 322 can assist in completing the final convergence. The total bending amplitude after the two are superimposed can make the end of the release part 320 away from the guide body 310 naturally away from the inner wall of the blood vessel 500, thereby effectively avoiding the tip contact between the release part 320 and the inner wall of the blood vessel 500, and thus achieving effective protection of the blood vessel 500.

[0072] It is understood that, in the embodiments of this application, the preferred values ​​are 135°≤α≤200° and 50°≤β≤350°, in which case the corresponding values ​​are 185°≤α+β≤550°. Where α can be any value from 135°, 140°, 145°, 150°, 155°, 160°, 165°, 170°, 175°, 180°, 185°, 190°, 195°, 200°, or a range between any two values; β can be 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260°, 270°, 28 ... 0°, 290°, 300°, 310°, 320°, 330°, 340°, 350°, or any value between any two values; the corresponding α+β can be any value between any two values ​​between any two values ​​between any two values ​​between any two values ​​between 0°, 290°, 300°, 315°, 230°, 245°, 260°, 275°, 290°, 305°, 320°, 335°, 350°, 365°, 380°, 395°, 410°, 425°, 440°, 455°, 470°, 485°, 500°, 515°, 530°, 545°, 550°.

[0073] Angle measurements can be taken using conventional angle measuring tools.

[0074] In some embodiments, the outer surface of the guide structure 300 is a smooth arc surface.

[0075] In this embodiment, the smooth arc-shaped guide structure 300 can effectively reduce the risk of frictional damage to the inner wall of the blood vessel 500 when in contact with it. Simultaneously, when adjusting the direct release position, the smooth arc-shaped surface reduces mechanical friction between the guide structure 300 and the inner wall of the blood vessel 500 as it is pushed or pulled within the vessel 500, improving the smoothness of the guide structure 300's movement and further protecting the blood vessel 500.

[0076] like Figure 7 As shown, in some embodiments, the outer surface of the sheath 100 and / or the outer surface of the guide structure 300 are coated with a super-slippery coating 400, which includes a fluoropolymer or a hydrophilic hydrogel material, and the thickness of the super-slippery coating 400 is 0.01 mm to 0.02 mm.

[0077] In this embodiment, the outer surface of the sheath 100 and / or the outer surface of the guide structure 300 are coated with a super-slippery coating 400, which can further reduce the frictional resistance of the stent 200 system within the blood vessel 500, thereby effectively reducing the risk of damage to the blood vessel 500.

[0078] One possible solution in this application is to coat the outer surface of the sheath 100 with a super-slippery coating 400, or to coat the outer surface of the guide structure 300 with a super-slippery coating 400, or to coat both the outer surface of the sheath 100 and the outer surface of the guide structure 300 with a super-slippery coating 400.

[0079] In this embodiment, the fluoropolymer (such as polytetrafluoroethylene) itself has extremely low surface energy, which can further reduce the coefficient of friction by more than 50% compared to a smooth arc surface. The hydrophilic hydrogel material forms a lubricating water film upon contact with blood, replacing direct friction between solids through "liquid lubrication," thus bringing the frictional resistance between the guiding structure 300 or sheath 100 and the wall of the blood vessel 500, and between the sheath 100 and the guiding structure 300, close to zero.

[0080] It is understood that the super-slippery coating 400 of this application embodiment can be used on the guide structure 300 with a smooth arc surface on the outer surface and on the sheath 100 with a smooth arc surface on the outer surface. In this case, the dual friction reduction setting can ensure that when the stent 200 system is adjusted in the blood vessel 500, the inner wall of the blood vessel 500 is not pulled or scratched by friction.

[0081] It should be noted that in this embodiment, the thickness of the super-lubricating coating 400 is set between 0.01 mm and 0.02 mm. The thickness of the super-lubricating coating 400 can be any one value or a range between any two values ​​from 0.01 mm, 0.011 mm, 0.012 mm, 0.013 mm, 0.014 mm, 0.015 mm, 0.016 mm, 0.017 mm, 0.018 mm, 0.019 mm, to 0.02 mm. Setting the thickness of the super-lubricating coating 400 between 0.01 mm and 0.02 mm ensures lubrication performance without increasing the outer diameter of the sheath 100 and / or the guiding structure 300, thus avoiding excessive space occupation within the vessel 500 lumen. This facilitates the effective execution of the stent 200 placement procedure and prevents damage to the inner wall of the vessel 500.

[0082] like Figure 6 As shown, in some embodiments, protrusions 110 are provided on both sides of the distal end of the sheath 100, and the outer surface of the protrusions 110 is an arc surface.

[0083] In this embodiment of the application, by providing protrusions 110 on both sides of the distal end of the sheath 100, the sheath 100 can move back and forth along the extension direction of the blood vessel 500 during the process of the sheath 100 entering the blood vessel 500 and being pushed forward. When a rotational tendency occurs, the protrusions 110 on both sides form abutment with the wall of the blood vessel 500, and the radial constraint of the blood vessel 500 cancels the lateral torque, thereby restricting the circumferential rotation of the sheath 100.

[0084] Furthermore, the outer surface of the protrusion 110 is curved, which reduces the friction between the protrusion 110 and the inner wall of the blood vessel 500, thereby improving the safety of the blood vessel 500.

[0085] In some embodiments, a developer (not shown in the figure) is uniformly distributed within the protrusion 110. The developer is at least one of tantalum, platinum, platinum alloy, gold, tungsten, iodine-containing compound, and barium.

[0086] In this embodiment, by evenly distributing the developing agent within the protrusion 110, the distal end of the sheath 100 can be accurately positioned, thereby enabling a visual operation of sheath 100 insertion. The posture of the sheath 100 can be dynamically monitored, abnormal states can be corrected in a timely manner, and the accuracy of stent 200 insertion operation can be improved.

[0087] In addition, the real-time development of the developer can form a double guarantee with the mechanical function of the protrusion 110 restricting the left and right rotation of the sheath 100. If the development shows that the sheath 100 has not rotated, it confirms that the anti-rotation function of the protrusion 110 is effective. If slight rotation occurs but the development indicates that the posture is controllable, the arc surface design characteristics of the protrusion 110 can be used to determine whether intervention is necessary.

[0088] Furthermore, the developer is at least one of the following: tantalum, platinum, platinum alloy, gold, tungsten, iodine-containing compounds, and barium. All of these developers have high density, ensuring clear development under X-rays and guaranteeing the development effect, thereby ensuring the positioning effect.

[0089] like Figure 4 As shown, in some embodiments, the outer surface of the support 200 is coated with a developing coating (not shown in the figure), the developing coating including at least one of tantalum, platinum, platinum alloy, gold, tungsten, iodine-containing compound, and barium.

[0090] In this embodiment of the application, by coating the outer surface of the stent 200 with a radiopaque coating, the state of the stent 200 during the release process can be tracked in real time, thereby achieving precise positioning and release of the stent 200.

[0091] Since the outer surface of the stent 200 is coated with a developing coating, the stent 200 can be fully developed, and its overall shape can be fully monitored. If any abnormality is found in the release position or deployment of the stent 200 during the release process, the stent 200 can be retracted in time and the release position can be readjusted.

[0092] It should be noted that the development coating on the stent 200 achieves full development, which, together with the protrusion 110 on the sheath 100 and the developer placed in the protrusion 110 to achieve development of the distal end of the sheath 100, achieves double development. Of course, the development coating can also be applied to the guide structure 300, in which case triple development can be achieved. This enables accurate positioning of each structure position and further improves the accuracy of the stent 200 release position.

[0093] The imaging coating includes at least one of tantalum, platinum, platinum alloy, gold, tungsten, iodine-containing compounds, and barium. An iodide coating is preferred, as it enables effective imaging without affecting the overall weight and avoids damage to the blood vessel wall from the metal.

[0094] like Figure 6 As shown, in some embodiments, the sheath 100 includes a main body segment 120, a folded-back segment 130, and a head segment 140. The folded-back segment 130 is connected to the distal end of the main body segment 120, and the guide body 310 is movably inserted into the main body segment 120 and the folded-back segment 130. The head segment 140 is connected to the end of the folded-back segment 130 away from the main body segment 120. The support 200 is movably disposed within the head segment 140, and the guide body 310 is movably inserted into the support 200 and the head segment 140. The release part 320 is movably inserted into the head segment 140 and is located at the end of the support 200 away from the folded-back segment 130.

[0095] In this embodiment, by dividing the sheath 100 into a main body segment 120, a folded segment 130, and a head segment 140, the folded segment 130 facilitates the looping of the sheath 100 within the aortic arch when it passes through the right radial artery, reducing the difficulty of forming the guide sheath 100. It also maintains the support of the sheath 100.

[0096] The main body section 120, the reverse fold section 130, and the head section 140 are integrally molded structures, which can ensure structural stability and smoothness of the outer surface.

[0097] like Figure 7 As shown, in some embodiments, the sheath 100 includes a polyimide wall 150 with a thickness of 0.15 mm to 0.2 mm.

[0098] In this embodiment, the sheath 100 is made entirely of polyimide, which can balance structural strength and flexibility, and adapt to the complex course of blood vessels 500.

[0099] Specifically, polyimide material possesses extremely high mechanical strength (tensile strength up to 150-200 MPa) and excellent fatigue resistance. A wall thickness of 0.15 mm to 0.2 mm ensures sufficient support while providing the sheath with appropriate flexibility. The wall thickness ranges from 0.15 mm to 0.2 mm, specifically any value or a range between any two of the following: 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, and 0.2 mm.

[0100] In addition, the sheath 100 is made of polyimide, which has good X-ray penetration and avoids interference with the developing system.

[0101] like Figure 8 As shown, in some embodiments, the sheath 100 includes a polyimide fiber layer 160, a polyester fiber layer 170, and a polyurethane fiber layer 180 stacked from the inside out. The thickness of the polyimide fiber layer 160 is 0.08 mm to 0.1 mm, the thickness of the polyester fiber layer 170 is 0.1 mm to 0.12 mm, and the thickness of the polyurethane fiber layer 180 is 0.08 mm to 0.1 mm.

[0102] In this embodiment, the polyimide fiber layer 160, serving as the inner layer (0.08 mm to 0.1 mm thick), provides basic support for the sheath 100 due to its high strength and excellent creep resistance, ensuring that the lumen is not prone to collapse when pushing and accommodating the guide structure 300. Simultaneously, its smooth inner surface reduces friction with internal instruments, improving operational smoothness. The intermediate polyester fiber layer 170 (0.1 mm to 0.12 mm thick) possesses excellent flexibility and tensile strength, enhancing the overall elasticity of the sheath 100. This allows the sheath 100 to flexibly bend along the course of the tortuous vessel 500, reducing the risk of hard damage to the vessel wall and compensating for the potential brittleness of polyimide under extreme bending. The outer polyurethane fiber layer 180 (thickness 0.08mm to 0.1mm) has good elasticity and flexibility, and can form a flexible fit when in contact with the vessel 500 wall, reducing frictional resistance during the pushing process. Its excellent wear resistance can protect the inner structure from mechanical damage to the vessel 500 wall. The three layers work together to form a gradient structure of "strong inside, soft in the middle, and compliant outside", which can balance strength and compliance.

[0103] In addition, the three-layer structure has good X-ray penetration, which reduces interference with imaging when the scaffold 200 is injected.

[0104] In some embodiments, the outer diameter of the head section 140 gradually decreases in the direction away from the folded section 130.

[0105] In this embodiment, the gradually decreasing outer diameter of the sheath 100 tip 140 reduces damage to the inlet and along the route of the blood vessel 500, improving the smoothness of the insertion. This is especially beneficial at narrowing or bifurcation points of the blood vessel 500, reducing endothelial damage caused by rigid pressure. It also reduces blood flow obstruction within the blood vessel 500, ensuring normal blood circulation.

[0106] like Figure 6 As shown, in some embodiments, the sheath 100 further includes a reinforcing layer 190, which is embedded in the tube wall of the folded section 130. The reinforcing layer 190 is a coiled metal wire with a coiling spacing of 0.5 mm to 0.6 mm.

[0107] In this embodiment, by providing a metal reinforcing layer 190 on the folded section 130, the strength of the folded section 130 can be effectively improved, thereby effectively enhancing its support. The winding spacing of the reinforcing layer 190 is 0.5mm to 0.6mm, which ensures both overall rigidity and allows for moderate bending deformation, preventing the formation of hard inflection points.

[0108] The winding spacing of the reinforcing layer 190 is 0.5mm to 0.6mm, specifically any value or a range between any two values ​​from 0.5mm, 0.52mm, 0.54mm, 0.56mm, 0.58mm, to 0.6mm.

[0109] It should be noted that all dimensions in this application can be measured using dimensional measuring tools.

[0110] In some embodiments, the guiding structure 300 is a microwire or a microcatheter.

[0111] In this embodiment, the guiding structure 300 is a microguidewire or microcatheter, which can be adapted to the microvascular channel 500 and improve the passability of complex vascular branches 500. When the guiding structure 300 is a microcatheter, contrast agents can be injected into the vascular 500 through the catheter to perform angiography.

[0112] In the above embodiments, the descriptions of each embodiment have different focuses. For parts not described in detail in a certain embodiment, please refer to the relevant descriptions in other embodiments.

[0113] The foregoing has provided a detailed description of a neurointerventional stent system provided in the embodiments of this application, and specific examples have been used to illustrate the principles and implementation methods of this application. The description of the above embodiments is only for the purpose of helping to understand the technical solutions and core ideas of this application. Those skilled in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or make equivalent substitutions for some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

Claims

1. A neurointerventional scaffold system, characterized in that, It includes a sheath (100), a support (200), and a guide structure (300), wherein the support (200) is movably disposed within the sheath (100); The guiding structure (300) includes: The guide body (310) is movably inserted into the sheath (100) and the bracket (200); A release section (320) is movably inserted inside the sheath (100). The release section (320) includes a first bent section (321) and a second bent section (322). The first bent section (321) is connected to one end of the guide body (310) along its length. The first bent section (321) extends in a direction that first moves away from the guide body (310) and then moves closer to the guide body (310). The second bent section (322) is connected to the end of the first bent section (321) that moves away from the guide body (310). The end of the second bent section (322) that moves away from the first bent section (321) extends in a direction that moves closer to the guide body (310).

2. The neurointerventional scaffold system according to claim 1, characterized in that, When the release portion (320) protrudes into the blood vessel (500), the portion of the second bent section (322) near the first bent section (321) abuts against the inner wall of the blood vessel (500), and the end of the second bent section (322) away from the first bent section (321) is spaced apart from the inner wall of the blood vessel (500).

3. The neurointerventional scaffold system according to claim 1, characterized in that, The second bending segment (322) is spaced apart from the guide body (310), and the center line of the second bending segment (322) is coplanar with the center line of the guide body (310).

4. The neurointerventional scaffold system according to claim 1, characterized in that, Both the first bending segment (321) and the second bending segment (322) are pre-designed arc-shaped segments.

5. The neurointerventional scaffold system according to claim 4, characterized in that, When the release part (320) is located inside the sheath (100), the central angle of the first bending segment (321) is α, and the central angle of the second bending segment (322) is β, satisfying: α > β.

6. The neurointerventional scaffold system according to claim 5, characterized in that, α and β satisfy: α + β > 180°.

7. The neurointerventional scaffold system according to claim 1, characterized in that, The outer surface of the guide structure (300) is a smooth arc surface.

8. The neurointerventional scaffold system according to claim 1, characterized in that, The outer surface of the sheath (100) and / or the outer surface of the guide structure (300) is coated with a super-slippery coating (400), the super-slippery coating (400) comprising a fluoropolymer or a hydrophilic hydrogel material, the thickness of the super-slippery coating (400) being 0.01 mm to 0.02 mm.

9. The neurointerventional scaffold system according to claim 1, characterized in that, The sheath (100) has protrusions (110) on both sides opposite to each other, and the outer surface of the protrusions (110) is an arc surface.

10. The neurointerventional scaffold system according to claim 9, characterized in that, The developing agent is uniformly distributed within the protrusion (110), and the developing agent is at least one of tantalum, platinum, platinum alloy, gold, tungsten, iodine-containing compound, and barium.

11. The neurointerventional scaffold system according to claim 1, characterized in that, The outer surface of the support (200) is coated with a developing coating, which includes at least one of tantalum, platinum, platinum alloy, gold, tungsten, iodine-containing compound, and barium.

12. The neurointerventional scaffold system according to claim 1, characterized in that, The sheath (100) comprises: Main body (120); A folded section (130) is connected to the far end of the main body section (120), and the guide body (310) is movably inserted into the main body section (120) and the folded section (130); The head section (140) is connected to the end of the folded section (130) away from the main body section (120). The bracket (200) is movably disposed within the head section (140). The guide body (310) is movably disposed within the bracket (200) and the head section (140). The release part (320) is movably disposed within the head section (140) and located at the end of the bracket (200) away from the folded section (130).

13. The neurointerventional scaffold system according to claim 12, characterized in that, The sheath (100) includes a polyimide tube wall (150) with a thickness of 0.15 mm to 0.2 mm.

14. The neurointerventional scaffold system according to claim 12, characterized in that, The sheath (100) comprises a polyimide fiber layer (160), a polyester fiber layer (170), and a polyurethane fiber layer (180) stacked from the inside out. The thickness of the polyimide fiber layer (160) is 0.08 mm to 0.1 mm, the thickness of the polyester fiber layer (170) is 0.1 mm to 0.12 mm, and the thickness of the polyurethane fiber layer (180) is 0.08 mm to 0.1 mm.

15. The neurointerventional scaffold system according to claim 12, characterized in that, The outer diameter of the head section (140) gradually decreases in the direction away from the reverse fold section (130).

16. The neurointerventional scaffold system according to any one of claims 12 to 15, characterized in that, The sheath (100) further includes a reinforcing layer (190), which is embedded in the tube wall of the folded section (130). The reinforcing layer (190) is a coiled metal wire with a coiling spacing of 0.5 mm to 0.6 mm.

17. The neurointerventional scaffold system according to any one of claims 1 to 15, characterized in that, The guiding structure (300) is a microguidewire or a microcatheter.

Images