Self-expanding stent, method of manufacturing the same, and stent assembly including the same

Abstract

The present application relates to a self-expanding stent (100) and a method of manufacturing the same, the stent being capable of assuming a collapsed configuration under an external force and self-expanding to the expanded configuration upon removal of the external force, the method comprising: providing a mesh sheet (10) comprising at least one column of mesh (12) connected in series; providing a core (20); winding the mesh sheet (10) on the core (20) to form a winding assembly comprising a winding body of the core (20) and the mesh sheet; heat treating the winding assembly to set the winding body into the stent (100) having a preset expanded configuration; and removing the core (20) from the stent (100). The present application also relates to a stent assembly comprising the self-expanding stent (100) as a plug and a plug.

Description

Technical Field

[0001] This application relates to a self-expanding stent and a method of manufacturing the same. The self-expanding stent of this application can be used as a packing stent (also known as a packing element or flow disruptor) in minimally invasive treatment of aneurysms (e.g., lateral wall, bifurcation, bilobed, wide neck, etc.) and other vascular diseases, or as a stent for capturing and removing thrombi (also known as a thrombus catcher) in thrombosis treatment.

[0002] This application also relates to stent assemblies comprising self-expanding stents (used as packing within anatomical structures) and plugging elements (used to block openings of anatomical structures from the outside). Background Technology

[0003] Self-expanding stents are used in many surgical procedures, such as minimally invasive interventional procedures. For example, in the treatment of intracranial aneurysms (such as large or giant saccular aneurysms, wide-necked aneurysms, fusiform aneurysms, and dissecting aneurysms), current embolization techniques (such as coil or stent-assisted coil embolization) can be used, but these techniques have drawbacks, including longer surgical time, difficulty in completely sealing the aneurysm neck, and incomplete aneurysm occlusion. The use of flow-disrupting devices also faces various challenges. For instance, woven lantern-like structures such as Web are relatively difficult to use for treating wide-necked aneurysms, while flow-disrupting devices or stents such as Contour may lack intra-aneurysmal support or have insufficient intra-aneurysmal support, resulting in poor anchoring within the aneurysm after implantation and potential collapse of varying degrees. In vascular treatment-related surgeries, the effectiveness of current self-expanding stents is also not ideal. Some stents, limited by their own structure and collapse configuration, are difficult to place in tortuous vessels, such as siphon bends.

[0004] Currently, there are methods for fabricating stents by laser-processing tubular components into hollow structures. However, on the one hand, the processing is complex and costly; on the other hand, the types and varieties of stents that can be manufactured using this method are limited, and only stents suitable for certain surgeries and applications can be produced. Summary of the Invention

[0005] The purpose of this application is to provide a method for manufacturing a novel self-expanding stent and a self-expanding stent manufactured using this method.

[0006] In a first aspect, a method for manufacturing a self-expanding stent is provided, the stent being capable of collapsing under external force and self-expanding to the expanded configuration upon removal of the external force, comprising: providing a mesh plate comprising at least one column of interconnected meshes; providing a core; winding the mesh plate around the core to form a winding assembly comprising the core and the mesh plate; heat-treating the winding assembly to shape the winding into a stent having a predetermined expanded configuration; and removing the core from the stent.

[0007] In some embodiments, the grid plate may have one or more of the following features: made of a material with shape memory function; obtained by laser cutting a plate-like piece; each grid defines a mesh, and both the grid and the mesh are rhomboid in shape, wider in the middle and tapering to opposite ends; the major axis of the rhomboid shape corresponds to the elongation direction of the grid plate; each grid includes a periphery defining the mesh, the periphery having a constant width; adjacent grids are directly connected at their respective vertices or connected via solid or hollow segments; the width of the hollow segments is comparable to the width of the periphery; and the grid plate includes at least one column of grids, each column containing three, four, five, six or more grids, and in the case of multiple columns, the grids in adjacent columns are staggered and share a portion of the periphery.

[0008] In some embodiments, the winding includes: temporarily fixing a first end of the mesh plate to the core, for example, the temporary fixing being constraining the first end of the mesh plate in at least one degree of freedom; and winding the mesh plate around the core.

[0009] In some embodiments, the temporary fixation is achieved by fitting the mesh at the first end of the mesh plate onto a short post fixed to the core.

[0010] In some embodiments, the core further includes at least one additional short post fixed thereon for constraining the wound mesh plate, the constraint being achieved by fitting the mesh of the mesh plate onto the short post or by having the mesh plate rest against the short post.

[0011] In some embodiments, each short post is fixed to a hole formed in the core by an interference fit and / or adhesive bonding.

[0012] In some embodiments, winding the mesh plate onto the core includes winding it in a manner in which adjacent winding turns partially overlap.

[0013] In some embodiments, the grid on the grid plate and the defined mesh openings have a rhomboid shape that is wider in the middle and tapers to opposite ends, with the long axis of the rhomboid shape along the extending direction of the grid plate. During winding, the extending direction is consistent with the winding direction of the grid plate, and the winding direction is perpendicular to the axis around which the winding is performed or is a spiral winding direction.

[0014] In some embodiments, winding the mesh plate onto the core includes, after the core is wound to form a winding layer, winding in the opposite direction around the same axis or continuing to wind around a different axis.

[0015] In some embodiments, the winding includes winding the mesh plate from its first end to its second end and then temporarily fixing the second end to itself, another mesh plate, or the core.

[0016] Preferably, the temporary fixation of the second end includes one of the following: fitting or abutting against a short post extending from the core, inserting into the mesh of other meshes; or adhering to itself, other mesh plates, or the core.

[0017] In some embodiments, the mesh plate includes a plurality of mesh plates, and a winding operation is performed sequentially on each mesh plate.

[0018] In some embodiments, at least one of the mesh plates includes a handle extending from a second end, and the winding includes placing the handle in a predetermined orientation after temporarily fixing the second end of the mesh plate.

[0019] In some embodiments, removing the core includes: releasing or destroying all temporary fixation between the mesh plate and the core; and removing the core from the support.

[0020] In some embodiments, removing the core further includes: applying an external force to the support to deform it and create an opening through which the core can pass before removing the core.

[0021] In some embodiments, the external force is a tensile force or a compressive force.

[0022] In some embodiments, the step of removing the core further includes removing the external force after removing the core to restore the support to its expanded configuration. In some embodiments, removing the core includes first removing the short post from the core, and then removing the core from the support. In some embodiments, where the mesh plate does not include a handle, the manufacturing method further includes: providing a handle; and attaching the handle to the support.

[0023] In a second aspect, a self-expanding support is provided, manufactured using the above-described manufacturing method, the support comprising at least one wound layer formed by winding at least one grid plate and defining a hollow cavity, the support having a predetermined expanded configuration in its natural state and a collapsed configuration under external force, and configured to self-expand from the collapsed configuration to the expanded configuration when the external force is removed, wherein adjacent wound turns in the same wound layer or different wound layers at least partially overlap.

[0024] In some embodiments, the mesh plate includes one or more columns of mesh connected in series, the mesh and the defined mesh openings having a rhomboid shape that is wider in the middle and tapers to opposite ends, the major axis of the rhomboid shape corresponding to the winding direction of the winding turn.

[0025] In some embodiments, the support includes a handle extending outward from the hollow cavity.

[0026] In some embodiments, the handle has at least one of the following features: integral with the mesh plate; a separate component connected to the bracket; and includes a through hole or a hook.

[0027] In a third aspect, a stent assembly is provided, comprising: a self-expanding stent according to the above description, configured for delivery into a patient's anatomy as a tampon; and a clogging member connected to the self-expanding stent and / or a shank extending from the self-expanding stent, the outer contour dimension of the clogging member being larger than the outer contour dimension of the stent.

[0028] In some embodiments, the plugging member includes a disc-shaped body comprising an inner annular portion and an outer annular portion, wherein the porosity of the inner annular portion is greater than that of the outer annular portion.

[0029] In some embodiments, the inner annular portion includes a plurality of lobed portions evenly distributed around the central hole; and / or, the outer annular portion includes a plurality of concentric ring portions and defines a rhomboid-shaped pore extending in the circumferential direction.

[0030] In some embodiments, the plugging member further includes a hub defining a central hole, with an inner annular portion of the disc-shaped body connected around the hub.

[0031] In some embodiments, the disc-shaped body has a concave side surface configured to face the support, and is inclined toward one side of the concave side surface while extending radially outward.

[0032] In some embodiments: the plug is directly attached to a self-expanding bracket, the bracket assembly excluding a handle or including a handle connected to the plug; or the bracket assembly includes a handle extending from the self-expanding bracket, the plug including a central hole allowing the handle to pass through, preferably, the plug also including a hub defining the central hole, the disc extending from the hub.

[0033] The method for manufacturing a self-expanding support according to this application includes the following steps: providing a mesh plate and a core; winding the mesh plate around the core to form a winding assembly (including the core and the wound body); heat-treating the winding assembly to shape the wound body into a support having a preset three-dimensional expansion configuration (hereinafter referred to as "expansion configuration"); and removing the core from the support. The term "mesh plate" generally refers to a plate-like member extending in a plane and composed of connected individual meshes. However, for ease of subsequent winding, the mesh plate is preferably a strip-like member whose dimension in one direction of the extending plane is much larger than its dimension in the vertical direction. More preferably, the mesh plate is a mesh strip comprising only one column of meshes.

[0034] By utilizing the winding method described in this application, and by selecting or designing cores with different geometric structures (shapes, sizes, etc.); by selecting, designing, or adjusting winding parameters (e.g., the slope of the spiral winding, the degree of overlap between adjacent winding turns or layers, the number of winding layers, the direction of winding, or the axis around which the winding is performed); and by rationally selecting the specifications (shape, size, arrangement) of the grid plate or grid, this application can obtain self-expanding stents of any desired three-dimensional expansion configuration, particularly self-expanding stents of any regular or irregular configuration (or outer contour), thus making them suitable for various patient anatomy structures (e.g., tumors in different locations, different blood vessels, etc.) and meeting the needs of various types of surgeries. Regularly configured self-expanding stents include approximately spherical, approximately ellipsoidal, configurations comprising multiple curved portions (e.g., lobular portions) arranged regularly (e.g., circumferentially around an axis), approximately polyhedral, etc. Compared to hollow structure stents formed by processing tubular parts and then heat-treating to shape them, this application is particularly advantageous in terms of the diversity of self-expanding stents that can be obtained and the types of surgeries that can be applied.

[0035] Using the method of this application, the self-expanding scaffold is completed by winding a mesh plate onto a core to form a wound body, then heat-treating it to form a finished scaffold with a preset expansion configuration, and finally removing the core. In addition to the inherent collapseability and compliance due to its hollow structure, the scaffold formed in this way also has stronger self-expandability, a more stable anchoring effect within anatomical structures, and can provide stronger outward support to anatomical structures. It is particularly suitable for applications or surgeries where it is placed within anatomical structures to provide outward support. In other words, the scaffold of this application can provide enhanced anchoring ability, support ability, anti-collapse ability, and anti-dislodgement ability.

[0036] This application further provides measures to make these advantages more apparent: each grid of the grid plate and its defined mesh openings have a generally rhomboid shape that bulges outward in the middle and tapers to opposite ends, with the long axis of the rhomboid shape along the extension direction of the grid plate and corresponding to the winding direction on the core, more preferably the winding direction is generally perpendicular to the axis around which the winding is performed, or a smaller slope is used when performing helical winding; the support formed by the winding method may have one or more winding layers, preferably the grid plates or grids of different winding layers or the winding turns of the same winding layer are arranged alternately or partially overlapping, and preferably the different winding layers are wound around different axes (or referred to as "cross winding").

[0037] Using the method of this application, multiple mesh plates can be wound to form a stent. The mesh plates (e.g., mesh plates of different layers or adjacent mesh plates of the same layer) can be bound together by heat treatment or by inserting one end of one mesh plate into another. The advantage of this is that the last wound mesh plate can be easily removed as needed to adapt to the stent requirements of different surgeries, patients, and anatomical structures. For example, this can reduce the size of the occlusion device, decrease the rigidity of the stent, and increase its compliance. This makes the stent more versatile and flexible.

[0038] The mesh plate used in this application can be obtained directly by purchasing and then cutting it to the required size, or it can be obtained by processing plate-shaped parts using laser cutting methods widely used in the art. Laser cutting a two-dimensional plate-shaped part into a mesh plate (or mesh strip) only requires the laser head or workpiece of the laser cutting equipment to move in a direction perpendicular to the plate. Compared to laser cutting tubular parts, which requires the laser head or workpiece to move in at least both the axial direction and the perpendicular radial direction of the tubular part, the laser cutting process of this application is simpler, has lower equipment requirements, is easier to control, and offers higher control and processing precision. This is essential in the field of processing medical devices intended for use inside the human body, as it is crucial to the success of surgery, the effectiveness of treatment, and even the patient's life.

[0039] In applications involving anatomical structures with a neck, such as tumors with a neck, the self-expanding stent of this application can be used as a tamponatory internal stent (referred to as a "tampon") placed within the anatomical structure to provide support. In this application, an external occlusive stent (referred to as a "occlusive") is also provided outside the anatomical structure to prevent blood from rushing in. This application also provides a combination of such a tampon and an occlusive – a "stent assembly".

[0040] As described above, when used as a packing material, the self-expanding stent of this application provides a stable anchoring effect, sufficient rigidity, strong internal support capacity, and the flexibility to adjust rigidity and support force in real time (e.g., on-site) based on actual applications. Utilizing the technology of this application, it is possible to obtain self-expanding stents of any regular or irregular configuration for use in various surgeries (e.g., carotid aneurysm surgery, Class III passive nerve and peripheral interventional surgeries). Attached Figure Description

[0041] Figure 1 This is a flowchart of the manufacturing method of the self-expanding stent of this application.

[0042] Figure 2 A grid strip is shown as an example of a grid plate.

[0043] Figure 3 yes Figure 2 An enlarged view of the handle of the grid plate.

[0044] Figure 4 This is an example of a core.

[0045] Figure 5 This illustrates the beginning of winding a mesh plate onto the core.

[0046] Figure 6 This is a schematic diagram of a winding assembly including a core and a winding completed on the core.

[0047] Figure 7 This is an embodiment of a self-expanding stent manufactured using the manufacturing method of this application.

[0048] Figure 8 This is another embodiment of a self-expanding stent manufactured using the manufacturing method of this application.

[0049] Figure 9 This is a side view of the extratumoral occlusion device used with the self-expanding stent of this application when it is used as an intratumoral occlusion device.

[0050] Figure 10 for Figure 9 A front view of the external plugging component.

[0051] Figure 11 It shows including Figure 7 Self-expanding stents and Figure 9 and 10 Stent assembly for extratumor occlusion.

[0052] Figure 12 It shows Figure 11 A variant of the support assembly.

[0053] Figure 13 It shows Figure 11 Another variant of the support assembly. Detailed Implementation

[0054] This application relates to a method for manufacturing a self-expanding stent and a self-expanding stent made using the method of this application.

[0055] The self-expanding stent manufactured using the method of this application has a pre-designed or predetermined three-dimensional expansion configuration in its natural state (or state without external force) and a collapsed configuration that emerges during delivery into the patient's anatomy. This self-expanding stent has sufficient compliance to deform into the collapsed configuration under external force (e.g., force applied by the delivery catheter during delivery) and sufficient self-expanding ability to self-recover or self-expand to the predetermined three-dimensional configuration after the removal of the external force. Therefore, the self-expanding stent manufactured using the method of this application is suitable for all applications or surgical procedures that require delivery into the patient's anatomy in a collapsed configuration and self-expanding to an expanded configuration upon reaching a predetermined location within the anatomy. For example, the self-expanding stent can be a thrombus catching device for capturing thrombi in the patient's anatomy and removing them from the patient's body; it can also be a tamponade device (or flow disruptor, or tampon) for placement and retention within the patient's anatomy (e.g., a tumor, blood vessel, etc.) to provide outward support to the anatomy.

[0056] The self-expanding stent of this application, when used as an occlusion device, can be used in conjunction with an external stent placed outside the anatomical structure to prevent blood flow into the anatomical structure. To distinguish it from the "occlusion device," the external stent is referred to as an "occlusion device." Both the occlusion device and the occlusion device require the aforementioned self-expanding properties, have their own expansion and collapse configurations, and are formed of a material with shape memory function. The materials forming the occlusion device and the occlusion device can be the same or different. This application does not limit their materials; any material with shape memory function known in the art can be used, with nickel-titanium alloys being an exemplary example.

[0057] The following is a reference. Figure 1 This application describes a method for manufacturing the self-expanding stent.

[0058] In general, the manufacturing method of the self-expanding support of this application may include: step S110 of providing a mesh plate; step S120 of providing a core; step S130 of winding the mesh plate onto the core to form a winding assembly including the core and the wound body; step S140 of heat-treating the winding assembly to shape the wound body into a support having a predetermined expansion configuration; and step S150 of removing the core from the support. The wound mesh plate 10 is referred to as a "wound part" before heat treatment shaping and as a "support" after heat treatment orientation.

[0059] The mesh plate in step S110 can be defined as a plate-like component composed of interconnected meshes, or an assembly of interconnected meshes arranged in the same plane (i.e., the extension plane of the mesh plate). Since this method requires a winding operation on the core, the preferred mesh plate in this application is a strip-like component that extends in one direction, i.e., a mesh strip.

[0060] Figure 2 A grid plate 10 in the form of grid strips is shown. Figure 2 In this embodiment, the grid plate 10 includes a series of grid cells (referred to as "grids") 12 connected in series in the extending direction T. Each grid 12 can be described as including a peripheral portion 14 and mesh openings 16 surrounding or defining it. The mesh openings 16 are generally shaped to taper from the middle to both ends, for example, a generally rhomboid shape as preferably illustrated. The peripheral portion 14 defining the mesh openings 16 has a substantially uniform width W in the extending plane, so that the peripheral portion 14 of each grid 12 is also generally rhomboid, and is also referred to herein as having a generally rhomboid shape or a rhomboid profile in the extending plane. The major axis (longer diagonal) of the rhomboid shape corresponds to the extending direction T of the grid plate 10 for the convenience of the subsequent winding step, and the minor axis (shorter diagonal) is transverse to or preferably perpendicular to the extending direction T, but this is not mandatory. It should be understood that the term "rhomboid shape" in this application refers generally to any shape that is wider in the middle and tapers to generally pointed ends in opposite directions.

[0061] exist Figure 2 In the example, the vertices of adjacent grids 12 can be directly connected, but it is also envisioned that the vertices of adjacent grids 12 can be connected by a connection section 22 of a certain length (see...). Figure 5 and 6 The connecting portion 22 is preferably elongated, for example, its width in the extending plane is comparable to the width W, to facilitate winding operations or winding control. Figure 5 As can be clearly seen, the connecting part 22 can also be hollow, or the connecting part 22 can be a different type of mesh than mesh 12.

[0062] exist Figure 2In the example, each grid 12 can have exactly the same detail parameters (e.g., shape, size, etc.). However, it is also envisioned that, considering one or more factors such as ease of winding on the core, detail of the applied anatomical structure, preset expansion configuration, the turbulence performance required by the scaffold, the rigidity or support performance required by the scaffold, the grid plate 10 can be designed such that the grids 12 closer to the ends (10a or 10b) have smaller or larger dimensions (or outer contours); or, grids 12 with different detail parameters can be arranged according to a certain pattern.

[0063] Although Figure 2 In the example, the mesh plate 10 includes only one column of mesh 12, but it is conceivable that the mesh plate 10 may include two or more columns of mesh 12. In the case of multiple columns of mesh, the meshes in adjacent columns can be arranged complementaryly and staggered, and the meshes 12 in adjacent columns can have the same or different detail parameters. The meshes in adjacent columns can, but do not necessarily have to, be designed to share some portions of the perimeter 14.

[0064] The opposite ends of the grid plate 10 formed by the series connection of grids 12 can be represented by the first end 10a and the second end 10b. Figure 2 The example grid plate 10 also includes a handle 18 integrally extending from the second end 10b, for example, but not limited to, extending away from the grid 12 in the extending direction T. The handle 18 is for connection with a delivery device and includes a connection feature for connection with the delivery device. In some embodiments, the connection feature may be a hole formed in the handle 18, for example, for engaging with a hook-like portion of the delivery device. The hole may be, for example... Figure 3 The elongated hole 15 in the enlarged view (e.g., to allow a degree of relative movement between the support and the delivery device during delivery) can be provided as a mesh of smaller size (similar to mesh 12), or it can be a through hole of any shape and size formed by laser cutting. In some embodiments, the connection feature can be a hook formed at the free end of the handle 18, for example, for engaging with a hole in the delivery device. The hook can be formed by laser cutting or by bending and shaping. Those skilled in the art will understand that any connection structure designed and used in association with a delivery device that can achieve the same function is within the scope of this application. It is also possible that the handle 18 itself can serve as the connection feature.

[0065] As a non-restrictive example, Figure 2The thickness of the grid plate 10 (in the direction perpendicular to the paper sheet) can be in the range of 0.03 mm to 0.20 mm; the width W of the periphery 14 of each grid 12 in the extending plane of the grid plate 10 can be between 0.025 mm and 0.1 mm; the major axis dimension of the rhomboid mesh 16 of each grid 12 in the extending direction T is in the range of 3 to 30 mm, and the minor axis dimension is in the range of 1 to 10 mm. The number of grids 12 in the grid plate 10 can be greater than 3, preferably greater than 5, especially when only one grid plate 10 is included.

[0066] The mesh plate of this application can be obtained by any possible means. In some examples, a suitable mesh plate can be purchased directly and optionally then cut to the required size. In some examples, step S110 can be obtained by laser cutting the plate-like part. Laser cutting of two-dimensional plate-like parts only requires the laser head or plate-like part of the laser cutting equipment to move in only one direction perpendicular to the plate-like part, which is advantageous. In contrast, laser cutting of three-dimensional tubular parts requires the laser head or tubular part to move in at least two degrees of freedom, in the axial direction of the tubular part and in a plane perpendicular to the axial direction (e.g., radial direction). Laser cutting of two-dimensional plate-like parts requires simpler equipment, simpler workpiece clamping and processing, simpler control of processing operations, higher processing accuracy, and correspondingly lower processing costs. This is more advantageous and safer for medical devices applied inside the human body.

[0067] In step S110, one, two, or more mesh plates 10 may be prepared. When multiple mesh plates 10 are included, only some of the mesh plates 10, preferably only one mesh plate 10, may include the handle 18. Furthermore, when multiple mesh plates 10 are included, each mesh plate 10 may be the same or different in details such as plate size, shape / size of the mesh 12, and connection of adjacent meshes 12.

[0068] The core 20 provided in step S120 can be made of materials such as stainless steel or nickel-titanium alloy, and other materials capable of withstanding the high temperatures of subsequent heat treatment operations can also be used. Depending on the desired expansion configuration of the support and other parameters of the support (rigidity, support force), the details of the core 20 can be appropriately selected or designed, such as in shape and size, to ensure that the mesh plate 10 presents the predetermined expansion configuration after winding. An example of a possible core 20 is a sphere (see...). Figure 5 ), ellipsoids, cylinders, prisms, truncated pyramids, etc.

[0069] Figure 4A typical example of a core 20 is shown. The core 20 has a polygonal solid structure, and its outer contour is defined by multiple planes. In this perspective view, a first pentagonal face 21 of the core 20 is visible, with side faces 23 extending from each side of the first face 21. It is conceivable that the figure shows a half of the core 20, and the core 20 could also include another half symmetrical to the half shown. In this case, the core 20 is a solid structure comprising two symmetrical truncated pyramids. It is also conceivable that all side faces 23 of the core 20 are connected to another plane opposite (parallel or non-parallel) to the first face 21, thus the core 20 can be a regular or irregular truncated pyramid structure. It is also possible that... Figure 4 The other side of the core 20 (not shown) is an irregular portion comprising one or more curved surfaces and / or one or more planes, thus the core 20 is a specially designed irregular core.

[0070] from Figure 4 The core 20 also includes short posts (e.g., nails) 28 protruding outward from one or more locations. These short posts 28 are secured to the core 20 in any possible manner to constrain the mesh plate 10 during winding, preventing undesirable displacement or slippage of the mesh plate 10. The short posts 28 can be secured to the core 20 in ways including, but not limited to: bonding the short posts 28 to the outer surface of the core 20; interference fitting and / or bonding the short posts 28 into holes formed in the core 20, etc.

[0071] For each mesh plate 10, the winding step S130 may include: an operation S132 of temporarily fixing the first end 10a of the mesh plate 10 to the core 20, an operation S134 of winding or wrapping the mesh plate 10 on the outer peripheral surface of the core 20, an optional operation S136 of temporarily fixing the second end 10b of the mesh plate 10, and an optional operation S138 of placing the handle 18 in a predetermined direction if the mesh plate 10 includes a handle 18. Figure 1 The dashed box indicates that this step is optional and not required.

[0072] It is understandable that if the core 20 is a spherical structure, such as Figure 5 In operation S132, the first end 10a of the mesh plate 10 can be temporarily fixed to any position of the core 20 as the starting position for the winding operation in operation S134. The temporary fixing in operation S132 can be achieved in any one or more possible ways. The temporary fixing is preferably detachable or removable, or it can be destructible, so that the mesh plate 10 can be separated from the core 20 and the core 20 can be removed after heat treatment and shaping. Figure 5The example given shows the mesh 12 at the first end 10a being "hung" on the short post 28 extending from the spherical core 20, but this application is not limited to this. "Temporary fixation" in this document can be understood as constraining at least one or more degrees of freedom, but not necessarily fixing in all degrees of freedom.

[0073] In some embodiments, if the core 20 is a polyhedral structure such as a cylinder or a truncated pyramid, the first end 10a of the mesh plate 10 can be fixed to the end face of the core 20 (e.g., Figure 4 The short column 28 on the surface 21).

[0074] In some embodiments, winding can be performed spirally about an axis, which can be defined by the core 20. Figure 5 In this context, the axis can pass through the center of the sphere and be perpendicular to the plane of the paper. The axis can also be along the major or minor axis of the ellipsoidal core 20, or the central axis of the cylindrical or conical core (e.g., passing through...). Figure 4 (The geometric center of face 21 and perpendicular to the paper).

[0075] In the winding operation of S134, the mesh plate 10 is wound onto the core 20 from the initial position of the fixed first end 10a, and adjacent winding turns may partially overlap each other. The degree of overlap between adjacent winding turns may be not less than the outer contour dimension or width of the mesh plate 10 in the direction perpendicular to the extension direction T (e.g., Figure 2 The maximum external dimension of the middle portion of the perimeter 14 of the central grid 12 is one-third, preferably about one-half. Wrapping in a partially overlapping manner has the advantages of increasing the tightness of the winding of the grid plate 10, improving the rigidity of the expanded configuration of the finished support, and enhancing the outward support capacity and stability of the anatomical structure when used as a plug.

[0076] In the winding operation of S134, if the core 20 is a cylindrical or conical core or other elongated structure, the grid plate 10 can be wound regularly, for example, in a spiral shape on the core 20, and the slope of the spiral can be reasonably designed to obtain the rigidity of the required three-dimensional support structure.

[0077] In some embodiments, the winding may be disordered or irregular, to Figure 5 For example, each turn can be wound around any axis or in any direction. When passing any short post 28, the corresponding mesh can be placed on the short post 28 or bent against the short post 28, thus performing flexible bending and temporary positioning.

[0078] for Figure 2For the mesh plate 10, its length in the extension direction T (i.e., the length defined by the first end 10a and the second end 10b) can be designed so that it just wraps around and covers the entire outer peripheral surface of the core 20. In this case, after the winding is completed in operation S134, operation S136 is performed to temporarily fix the second end 10b. This temporary fixation can be performed in the same way as in operation S132; by passing the second end 10b through the mesh opening 16 of any mesh 12; or by gluing, pressing, or snapping the second end 10b onto itself, the core 20, or other mesh plates 10.

[0079] Then, in optional operation S138, the handle 18 of the grid plate 10 is oriented in a predetermined direction. The handle 18 may automatically extend along the predetermined direction, or the handle 18 may be bent around the second end 10b to orient it in the predetermined direction. For the spherical core 20, this predetermined direction may be a generally radially outward direction at the second end 10b. For the cylindrical or conical core 20, this predetermined direction may be along the axial direction of the cylindrical or conical core 20, or any other pre-defined direction that ensures the handle 18 extends through the neck of the aneurysm after the support is placed inside the aneurysm.

[0080] In some embodiments, the length of the mesh plate 10 is designed to have remaining length after winding around the entire outer peripheral surface of the core 20. In this case, the mesh plate 10 can continue to be wound regularly or arbitrarily, for example, winding the mesh plate 10 in the opposite direction around the same axis, or it can continue to be wound around an axis different from the previous axis to form a second layer. Similarly, after winding to the second end 10b of the mesh plate 10, operations S136 and S138 are performed in a similar manner as described above.

[0081] Based on the desired three-dimensional configuration of the support, it is also possible to design the length of the grid plate 10 to only wrap around or cover a portion of the outer peripheral surface of the core 20.

[0082] In the case of multiple mesh plates 10, this winding step S130 is repeated for each mesh plate. In this case, the mesh plates are wound sequentially, and the axis around which the winding is performed can be changed according to the actual situation. In the case of multiple mesh plates 10, one of the mesh plates 10 includes the aforementioned handle 18. Alternatively, two or more mesh plates 10 may each include a handle, but the lengths of these mesh plates 10 must be designed in a related manner or their winding methods must be designed in a related manner so that after the mesh plates 10 are wound, all the handles 18 can come together and extend together in a predetermined direction after operation S138.

[0083] This winding operation S134 can form one or more winding layers on the core 20. Preferably, the grids 12 of adjacent winding layers are staggered to improve the rigidity, stability and support capacity of the finished support.

[0084] For the mesh plate 10 including the handle 18, regardless of the degree to which the mesh plate 10 covers the outer peripheral surface of the core 20 after winding, operation S138 ensures that the handle 18 of the mesh plate 10 is placed in a predetermined orientation. It should be understood that it is also possible for all mesh plates 10 not to include the handle 18. In this case, step S130 does not include operation S138.

[0085] Figure 6 An example of a wound assembly comprising a core and a wound body, formed after the winding step S130, is shown, which may occur before or after the heat treatment step S140. In this example, the wound body is approximately spherical.

[0086] In step S140, the winding assembly is heat-treated to stabilize the relative positions, dimensions, and orientations of the various parts of the winding body wound on the core 20. The resulting configuration is the preset expanded configuration of the finished bracket. The bracket of this application will remain in this configuration under natural conditions. The specific heat treatment steps or operations are not the focus of this application and will not be described in detail here.

[0087] Next, the manufacturing method performs step S150 of removing the core 20 from the support in the predetermined expansion configuration. This step first includes operation S152 of releasing all temporary fixations associated with the core 20.

[0088] In operation S152, all temporary fixations (or constraints on at least one degree of freedom) between the mesh plate 10 (first end 10a and / or second end 10b) and the core 20 are released, for example by disconnecting the detachable connection (e.g. Figure 5 (e.g., temporary fixation), or disrupting the connection between the grid plate 10 and the core 20 (e.g., bonding).

[0089] After the winding body (referred to as support 100 at this time) is disconnected from the core 20, the core 20 can be directly removed—operation S154—if there is an opening on support 100 through which the core 20 can pass. This opening can be any mesh 16 of the grid 12, or it can be an opening that is naturally formed or left when the grid plate 10 is wound onto the core 20. Optionally, depending on the situation, operation S154 of removing the core 20 may include removing the short post 28 from the core 20 and then removing the core 20.

[0090] However, in some cases, if there is no opening on the support 100 through which the core 20 can pass, and the core 20 cannot be directly removed, then step S150 may include: applying an external force to the support to deform it into an opening through which the core 20 can pass, operation S156. Therefore, this operation S156 is optional. Operation S156 can be performed by stretching or compressing the support 100, deforming the mesh 16 of one of its grids 12 to create an opening through which the core 20 can pass. Two different parts of the support 100 can be stretched or compressed arbitrarily to create an opening through which the core 20 can pass at any point on the support 100. Then, operation S154 is performed.

[0091] After completing the operation S154 of removing the core 20, this step S150 may also include the operation S158 of removing external force or loosening the bracket 100, and the bracket will then restore the preset three-dimensional configuration.

[0092] At this point, step S150 is completed, the manufacturing method ends, and the bracket 100 is manufactured.

[0093] Optionally, as described above, if any grid plate 10 does not include a handle 18, the manufacturing method may further include step S160 of providing a separate handle 18 component and attaching it to the appropriate location on the bracket 100. Step S160 is optional. This attachment may also be any one or more of welding, hooking, crimping, bonding, etc.

[0094] The expansion configuration of the support 100 prepared by the winding method of this application varies depending on the structure of the core 20, the number of grids 12 of the grid plate 10, the connection method between adjacent grids 12, and the winding method of the grid plate 10. Figure 7 and 8 Two different expansion configurations are obtained by winding grid plates 10 with different numbers or arrangements of grids 12 on different cores 20 in different ways.

[0095] Figure 7 The support structure is roughly spherical. Figure 7 In this configuration, the mesh plate 10 can be wound spirally around a spherical core, such that the winding direction corresponding to the major axis of each rhomboid mesh 12 is approximately perpendicular to the axis around which it is wound (the central axis extending along the handle 18). This support 100 exhibits excellent self-expanding performance along the direction of the handle 18. The applicant also envisions a variation of this structure where, to provide greater outward support force, an auxiliary support structure 54, such as a support spring (coil) or other similar structure (see reference). Figure 13 ).

[0096] Figure 8The support is a generally polyhedral (trihedral) configuration for placement within a specific nodule structure. Viewed along the handle 18, the support 100 includes three lobed, outwardly convex curved portions arranged around the handle 18. The support 100 includes an outwardly convex end at one end of the handle 18 and a generally flat end at the opposite end.

[0097] In some embodiments, the support may include one or more of the following features: at least one winding layer formed by winding around an axis in the extending direction of the handle 18, at least one winding layer formed by winding around an axis transverse to or substantially perpendicular to that direction, at least one winding layer formed by winding around an axis inclined to the direction, etc. The support 100 thus formed has a more balanced self-expansion capability in all directions.

[0098] It is conceivable that, all other things being equal, the fewer the number of grids 12, the more the three-dimensional configuration of the finished support 100 resembles a polyhedron (or, more precisely, a regular or irregular configuration including three or more lobed convex curved surfaces, for example...). Figure 8 All other things being equal, the more layers of winding, the more regular the three-dimensional configuration becomes, and the closer it is to a sphere. The various properties (rigidity, expansion, stability within the anatomical structure, and self-recovery) are more balanced in all directions.

[0099] As described above, the self-expanding stent 100 of this application can be used as a thrombus capture stent, or as a packing stent or packing component. Figure 9 and 10 An example of an extratumoral occlusion device 200 used when the self-expanding stent 100 is used as an intratumoral occlusion device is shown.

[0100] The plug 200 can be connected to the bracket 100 and / or the handle 18. The plug 200 can be a braided structure. In the example of this application, the plug 200 includes a central hole 42 through which the handle 18 on the bracket 100 passes, and is secured to the handle 18 by welding and / or bonding.

[0101] Figure 9 and 10 The plug 200 shown is a disc-shaped component, including a disc body 40 and a hub 50 defining a central hole 42. The disc body 40 includes an inner annular portion 44 connected around the hub 50 and an outer annular portion 46 connected around the inner annular portion 44. The disc body 40 has a concave side surface (not shown) configured toward the support 100 and thus toward the target anatomical structure, and an opposite convex side surface 41 (…). Figure 9The outer peripheral edge 47 of the disc-shaped body 40, i.e., the outer peripheral edge 47 of the outer annular portion 46, is offset toward the bracket 100 relative to the inner annular portion 44 connected to the hub 50 in the extending direction of the central hole 42. This configuration facilitates the transformation of the plug 200 between an expanding configuration and a collapsing configuration.

[0102] Generally, the plugging element 200 can be designed as a braided structure, for example, formed by braiding filaments. The porosity of the inner annular portion 44 of the disc-shaped body 40 is greater than that of the outer annular portion 46, and the outer annular portion 46 is braided progressively denser in the radially outward direction to improve the sealing effect. In one example, the coverage of the braided material in the inner annular portion 44 is less than the coverage of the braided material in the outer annular portion 46, for example, the former is less than 10%, preferably in the range of 1% to 8%, more preferably about 5%, and the latter is greater than 30%, preferably in the range of 40% to 80%, more preferably about 60%. The maximum profile dimension of the plugging element 200, specifically the outer annular portion 46, is greater than or equal to the maximum profile dimension of the stent 100. The outer profile of the outer annular portion 46 is generally, but not limited to, circular. In applications where the anatomical structure is a tumor, when in a three-dimensional expansion configuration, the maximum profile dimension of the stent 100 can be in the range of 2 to 15 mm, and the maximum outer profile dimension or maximum outer diameter of the plugging element 200 can be in the range of 2 to 20 mm.

[0103] In the specific example illustrated, the inner annular portion 44 includes a plurality of lobed portions extending evenly spaced around the hub 50, such as four smaller lobes 45a and four larger lobes 45b intersecting with two adjacent smaller lobes 45a. The gap defined by each lobe is wider radially inward and tapers convexly to the radially outer end. The outer annular portion 46 includes a rhomboid shape in which its defined gap extends in the circumferential direction, and may be configured to have a smaller gap closer to the outer peripheral edge 47. It is conceivable that the plug 200 may include a cylindrical portion extending axially from the outer peripheral edge 47.

[0104] The braided wire can be made of shape-memory metal wires such as nickel-titanium or cobalt-chromium, and further options include braided wires with a platinum core to enhance imaging. The number of braided wire ends ranges from 12 to 128. The braiding of the external stent can employ any known braiding technique in the art, such as 1-on-1 or 2-on-2 wire pressing techniques. The wire diameter ranges from 0.00075” to 0.003”. This braiding method can effectively seal the aneurysm neck, preventing blood flow from impacting the aneurysm cavity and achieving complete occlusion of the aneurysm cavity.

[0105] Figure 9 and 10 Three embodiments of the support assembly formed by connecting the plug 200 with the filler 100 manufactured using the manufacturing method of this application are described. Figures 11 to 13 It is shown in the figure. Figure 11 The support assembly includes components made of Figure 7 The bracket 100 and Figure 9 and 10 200 blocking components. Figure 12 It shows Figure 11 A variant of the support assembly. Figure 12 Unlike Figure 11 The only difference is the addition of a radiopaque element 52 to the handle 18 to allow real-time visualization of the stent assembly's position within the patient's body during surgery, for tracking purposes. In this example, the radiopaque element 52 is a radiopaque tube fitted and secured (e.g., crimped, glued, etc.) to the handle 18; its material can be gold, platinum-tungsten, platinum-iridium, or tan. This application does not limit the specific structure of the radiopaque element 52 as long as the radiopaque function is achieved. Figure 13 The support assembly is different Figure 11 The only difference is that an additional, elastic support structure, such as a spring wire or other spring structure, has been added within the support 100.

[0106] The stent assembly of this application is applicable to clinical wide-necked aneurysms, saccular aneurysms with jet needle-like blood flow, etc., and the stent 100 can provide sufficient support within the aneurysm cavity.

[0107] Although the examples above are all described as having the handle 18 and the bracket 100 as an integral structure, the applicant envisions: a bracket assembly excluding the handle 18; a handle 18 provided separately; and the handle 18 being integrated with the plug 200. These are all within the scope of this application.

[0108] In embodiments where the handle 18 is provided as a separate component, the plug 200 can be directly attached to the inner support 100. The plug 200 can be directly hooked or pressed into the perforated inner support 100. It is also conceivable that each end of any mesh plate 10 may be provided with a section (e.g., a mesh 12, or a portion thereof) that is not wound, extending beyond the neck opening for attachment of the plug 200. A separate handle 18 may be provided, which can be attached to the plug 200 in any of the aforementioned attachment methods, in which case the handle 18 is used solely for connection to the delivery device.

[0109] The handle 18 may be integral with the plug 200, for example, provided by a section or portion of the braided filaments of the plug 200. For example, the braided filaments may be bent into hooks or loops for connection with a complementary coupling structure of the delivery device.

[0110] The foregoing description, with reference to the accompanying drawings, outlines some, but not all, embodiments that implement the principles of this application. Features in different embodiments can be combined with each other, and modifications, additions, deletions, substitutions, etc., can be made to the features and aspects shown in the figures and described above without departing from the principles of this application to form new embodiments, all of which are within the scope of protection of this application.

Claims

1. A method for manufacturing a self-expanding stent (100), the stent being capable of collapsing under external force and self-expanding to an expanded configuration when the external force is removed, the manufacturing method comprising: A grid plate (10) is provided, the grid plate comprising at least one column of grids (12) connected in series; Provide core (20); The mesh plate (10) is wound around the core (20) to form a winding assembly comprising the core (20) and the mesh plate, wherein winding the mesh plate (10) around the core (20) comprises winding in such a manner that adjacent winding turns partially overlap. The winding assembly is heat-treated to shape the wound body into a support (100) having a predetermined expansion configuration; and Remove the core (20) from the support (100).

2. The manufacturing method according to claim 1, wherein, The grid plate (10) has one or more of the following characteristics: Made of materials with shape memory function; Obtained by laser cutting of plate-shaped parts; Each grid (12) defines a mesh (16), and both the grid (12) and the mesh (16) are diamond-shaped, wider in the middle and tapering to opposite ends; The major axis of the rhombus shape corresponds to the elongation direction (T) of the grid plate (10). Each grid (12) includes a periphery (14) defining the mesh (16), the periphery (14) having a constant width (W). Adjacent grids (12) are connected directly at their respective vertices or via solid or hollow segments (22); The width of the hollow section is equivalent to the width (W) of the peripheral portion (14); and The grid plate (10) includes at least one column of grids (12), and the number of grids (12) in each column is three, four, five, six or more. In the case of multiple columns, the grids in adjacent columns are staggered and share a portion of the perimeter (14).

3. The manufacturing method according to claim 1, wherein, The winding includes: The first end (10a) of the mesh plate (10) is temporarily fixed to the core (20); and The grid plate (10) is wound around the core (20).

4. The manufacturing method according to claim 3, wherein, The temporary fixation is to constrain the first end (10a) of the grid plate (10) in at least one degree of freedom.

5. The manufacturing method according to claim 3, wherein, The temporary fixation is achieved by fitting the mesh of the first end (10a) of the mesh plate (10) onto a short post (28) fixed to the core (20).

6. The manufacturing method according to claim 5, wherein, The core (20) also includes at least one additional short post fixed thereto for constraining the wound mesh plate (10), the constraint being achieved by fitting the mesh of the mesh plate onto the short post or by having the mesh plate (10) rest against the short post.

7. The manufacturing method according to claim 6, wherein, Each short post (28) is fixed to the hole formed on the core (20) by interference fit and / or bonding.

8. The manufacturing method according to claim 7, wherein, The grid (12) on the grid plate (10) and the defined mesh (16) have a rhomboid shape that is wider in the middle and gradually narrows to opposite ends. The long axis of the rhomboid shape is along the extension direction (T) of the grid plate. During the winding process, the extension direction (T) is consistent with the winding direction of the grid plate (10). The winding direction is perpendicular to the axis around which the winding is performed or is a spiral winding direction.

9. The manufacturing method according to claim 7, wherein, Winding the mesh plate (10) onto the core (20) includes, after winding the core (20) to form a winding layer, winding in the opposite direction around the same axis or continuing to wind around different axes.

10. The manufacturing method according to any one of claims 5-9, wherein, The winding includes winding the mesh plate (10) from its first end to its second end and then temporarily fixing the second end to itself, or to another mesh plate, or to the core.

11. The manufacturing method according to claim 10, wherein, The temporary fixation of the second end includes one of the following: fitting or abutting against a short post (28) extending from the core, inserting into the mesh of other meshes; or adhering to itself, other mesh plates, or the core.

12. The manufacturing method according to any one of claims 1-9, wherein, The grid plate (10) includes multiple grid plates, and a winding operation is performed on each grid plate in sequence.

13. The manufacturing method according to claim 12, wherein, At least one of the mesh plates (10) includes a handle (18) extending from a second end (10b), the winding comprising: placing the handle (18) in a predetermined orientation after temporarily fixing the second end (10b) of the mesh plate.

14. The manufacturing method according to any one of claims 5-9, wherein, Removing the core (20) includes: releasing or destroying all temporary fixation between the mesh plate (10) and the core (20); and removing the core (20) from the bracket (100).

15. The manufacturing method according to claim 14, wherein, Removing the core (20) further includes applying an external force to the support (100) before removing the core (20) to deform it and form an opening through which the core (20) can pass.

16. The manufacturing method according to claim 15, wherein, The external forces are tensile and compressive forces.

17. The manufacturing method according to any one of claims 15-16, characterized in that... At least one of the following: The step of removing the core (20) further includes removing the external force after removing the core (20) to restore the support to the expanded configuration; Removing the core (20) includes first removing the short post (28) from the core (20), and then removing the core (20) from the support (100). In the case where the grid plate (10) does not include the handle (18), the manufacturing method further includes: providing the handle (18); and attaching the handle (18) to the bracket (100).

18. A self-expanding stent (100), manufactured using the method of any one of claims 1-16, the stent comprising at least one wound layer formed by winding at least one mesh plate (10) and defining a hollow cavity (105), the stent having a predetermined expanded configuration in its natural state and a collapsed configuration under external force, and configured to self-expand from the collapsed configuration to the expanded configuration when the external force is removed. in, Adjacent turns in the same winding layer overlap at least partially.

19. The self-expanding stent (100) according to claim 18, wherein, The mesh plate (10) includes one or more columns of meshes (12) connected in series. The meshes (12) and the mesh openings (16) they define have a rhomboid shape that is wider in the middle and tapers to opposite ends. The major axis of the rhomboid shape corresponds to the winding direction of the winding turn.

20. The self-expanding stent (100) according to claim 18 or 19, wherein, The support includes a handle (18) extending outward from the hollow cavity (105).

21. The self-expanding stent (100) according to claim 20, wherein, The handle (18) has at least one of the following features: Integrated with the grid plate (10); It is a separate component connected to the bracket (100); This includes through holes or hooks.

22. A support assembly, comprising: The self-expanding stent (100) according to any one of claims 18-19 is configured to be delivered into the patient's anatomy as a tampon; and A plug (200) is connected to the self-expanding bracket (100) and / or a handle (18) extending from the self-expanding bracket, the outer contour dimension of the plug (200) being larger than that of the bracket (100).

23. The support assembly according to claim 22, wherein, The plugging component (200) includes a disc-shaped body (40), which includes an inner annular portion (44) and an outer annular portion (46), wherein the porosity of the inner annular portion (44) is greater than that of the outer annular portion (46).

24. The support assembly according to claim 23, wherein, The inner annular portion (44) has a central hole (42) and includes a plurality of lobes evenly distributed around the central hole (42); and / or, the outer annular portion (46) includes a plurality of concentric ring portions and defines a rhomboid-shaped pore extending in the circumferential direction.

25. The support assembly of claim 24, wherein, The plug (200) also includes a hub (50) defining a central hole (42), and an inner annular portion (44) of the disc-shaped body (40) is connected around the hub (50).

26. The support assembly according to any one of claims 23-25, wherein, The disc-shaped body (40) has a concave side surface configured to face the support (100) and is inclined toward one side of the concave side surface while extending radially outward.

27. The support assembly according to any one of claims 23-24, wherein: The plug (200) is directly fixed to the self-expanding bracket (100), the bracket assembly either excluding the handle (18) or including the handle (18) connected to the plug (200); or The support assembly includes a handle (18) extending from a self-expanding support (100), and the plug (200) includes a central hole (42) that allows the handle (18) to pass through.

28. The support assembly of claim 27, wherein, The plug (200) also includes a hub (50) defining a central hole (42), from which the disc (40) extends.

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