Aneurysm occlusion apparatus and system for aneurysm occlusion

Abstract

The application discloses an aneurysm occlusion apparatus and a system for aneurysm occlusion. The aneurysm occlusion apparatus is configured to have an elongated configuration suitable for being conveyed in the radial direction, and an expanded configuration which is elastically converted from the elongated configuration and can radially expand. The expanded configuration comprises, connected in sequence, a converging section located at the near end, an extension section, and an expansion section connected to the far end of the extension section. The expansion section extends towards the axis of the occlusion apparatus. The extension section and the expansion section are circumferentially enclosed to form an inner cavity. The free end of the expansion section is circumferentially enclosed to form an annular opening communicated with the inner cavity. After the occlusion apparatus is placed in the aneurysm, the extension section occludes the neck of the aneurysm and is tightly attached to the wall of the aneurysm, and the expansion section fills the cavity of the aneurysm, so as to reduce blood flow reaching the top of the aneurysm from a feeding artery, such that the blood flow in the cavity of the aneurysm is slower, which is beneficial to the formation of thrombus and healing of the aneurysm, and in addition, the occlusion apparatus can be prevented from detaching from the neck of the aneurysm.

Description

Aneurysm occlusion device and system for occluding aneurysm

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to the Chinese patent application filed with the China Patent Office on November 29, 2023, with application number 202311615817.5 and invention name “Aneurysm occlusion device and system for occluding aneurysms”, the entire contents of which are incorporated by reference into this application. Technical Field

[0003] The present application relates to the technical field of occlusion devices, and in particular to an aneurysm occlusion device and a system for occluding an aneurysm. Background Art

[0004] Intracranial aneurysms are a common intracranial disease, with a prevalence of approximately 7%-9%. They pose a significant risk to the human body. Rupture can cause hemorrhagic stroke, coma, or even death, posing a significant threat to human health.

[0005] Currently, the main treatment options for aneurysms include surgical clipping, coils with stents, and intra-aneurysmal flow-disrupting braids. Surgical clipping carries significant risks and costs, placing significant financial and emotional strain on patients. Coils with stents are a promising interventional aneurysm treatment option, but they are not suitable for wide-necked bifurcation aneurysms. For wide-necked bifurcation aneurysms, one company pioneered a lantern-shaped intra-aneurysmal flow-disrupting braid. While this device has shown some clinical effectiveness, it also has several limitations. Its lantern-like shape hinders its adaptability to aneurysms, requiring numerous sizes to accommodate different aneurysms and resulting in poor conformability. Subsequently, another company developed another typical occlusion device, resembling an open bowl, primarily for occluding the aneurysm neck. Because of its open design, only the size of the aneurysm neck, not the shape of the aneurysm, is considered. A single size can accommodate a wide range of aneurysms, improving conformability and achieving a similar one-year aneurysm occlusion rate. However, the bowl-shaped occlusion device has a dense metal mesh only distributed at the neck of the tumor, and there is no filler inside the tumor. Due to the inevitable blood flow through the occlusion device into the tumor and / or the existence of vortexes within the tumor, the period for blood to form a thrombus within the tumor may be longer than that of an occlusion device with fillers. In addition, the bowl-shaped occlusion device has no support and relies solely on the bowl-shaped side wall to adhere to the tumor wall, which may pose a risk of falling off in the long term.

[0006] Therefore, it is necessary to design an aneurysm occlusion device and a system for occluding an aneurysm to solve the above problems. Summary of the Invention

[0007] Therefore, the technical solution proposed in this application aims to solve the following problems in the prior art: (1) the compatibility problem between the configuration of the occlusion device and the size of the aneurysm, (2) the absence of fillers in the aneurysm, resulting in slower thrombosis formation, and (3) the risk of falling off in the long term due to the radial support force provided by the side wall alone, thereby providing an aneurysm occlusion device and a system for occluding an aneurysm.

[0008] To solve the above technical problems, the technical solutions of this application are as follows:

[0009] An aneurysm occlusion device is constructed to have a radially compressed slender configuration suitable for delivery, and an expanded configuration elastically transformed from the slender configuration to a radially expanded configuration, the expanded configuration including a gathering portion located at the proximal end, an extension segment, and an enlarged segment connected to the distal end of the extension segment, the enlarged segment extending toward the axis of the occlusion device, the enlarged segment having an inner side surface of the enlarged segment facing the inner cavity and an outer side surface of the enlarged segment facing away from the inner cavity, the extension segment and the enlarged segment circumferentially enclose an inner cavity, and the free end of the enlarged segment circumferentially encloses a ring-shaped opening connected to the inner cavity.

[0010] Optionally, when the blocking device is in the expanded configuration, the extension section extends from a position near the axis toward a direction away from the axis, and the enlarged section extends from a position away from the axis toward the axis.

[0011] Optionally, a width of the enlarged section extending toward the axis is greater than a height of the enlarged section extending along the axis.

[0012] Optionally, when the blocking device is in the expanded configuration, the blocking device is subjected to radial extrusion force, and the annular opening becomes smaller.

[0013] Optionally, the annular opening moves proximally or distally.

[0014] Optionally, when the sealing device is in a non-slender configuration, the outer side surface of the expanded section is circumferentially enclosed to form a first conical cavity, the tip of the first conical cavity is toward the proximal end and connected to the annular opening, or the inner side surface of the expanded section is circumferentially enclosed to form a second conical cavity, the tip of the second conical cavity is toward the distal end and connected to the annular opening.

[0015] Optionally, the portion of the extension section where it is connected to the enlarged section is a turning portion, and in a direction parallel to the axis of the occluding device, the free end of the enlarged section is directed toward the proximal end relative to the turning portion, or the free end of the enlarged section is directed toward the distal end relative to the turning portion, or the free end of the enlarged section is flush with the turning portion.

[0016] Optionally, the free end of the expanded section faces the proximal end relative to the turning portion, and when the blocking device is squeezed by radial force, the inner side of the expanded section approaches the extension section, and the outer side surfaces of the expanded section approach each other circumferentially.

[0017] Optionally, when the blocking device is not squeezed by radial force, the first conical cavity has a first taper angle; when the blocking device is squeezed by radial force, the first conical cavity has a second taper angle, and the second taper angle is smaller than the first taper angle.

[0018] Optionally, the free end of the expanded section faces the distal end relative to the turning portion, or the free end of the expanded section is flush with the turning portion, and when the blocking device is squeezed by radial force, the outer surface of the expanded section extends toward the distal end.

[0019] Optionally, when the blocking device is not squeezed by radial force, the second conical cavity has a third taper angle; when the blocking device is squeezed by radial force, the second conical cavity has a fourth taper angle, and the fourth taper angle is smaller than the third taper angle.

[0020] Optionally, when the sealing device is squeezed by radial force, the annular opening is closed.

[0021] Optionally, the inner side surface of the expanded section and the outer side surface of the expanded section are both arc-shaped surfaces, both arched toward the distal end, or the inner side surface of the expanded section arches toward the proximal end, and the outer side surface of the expanded section arches toward the distal end.

[0022] Optionally, the blocking device is a single-layer structure obtained by pre-shaping an elastic tube body with non-uniform wall thickness, or the blocking device is a double-layer structure obtained by pre-shaping a double-layer mesh tube.

[0023] Optionally, the number of the expanded sections is at least two, and at least two of the expanded sections are vertically spaced apart along the axial direction.

[0024] Optionally, the outer side surface of the expanded section is partially recessed toward the inner side surface of the expanded section, or the inner side surface of the expanded section is partially recessed toward the outer side surface of the expanded section to form at least one expanded section recessed portion, and / or,

[0025] The outer side surface of the extension section faces the inner side surface of the extension section, or the inner side surface of the extension section is partially recessed toward the outer side surface of the extension section to form at least one extension section recessed portion.

[0026] The technical solution of this application has the following advantages:

[0027] 1. The aneurysm occlusion device provided in the present application is constructed to have a slender configuration with radial compression suitable for delivery, and an expanded configuration that elastically changes from the slender configuration to a radially expanded configuration, the expanded configuration includes a connected gathering portion at the proximal end, an extension section, and an enlarged section connected to the distal end of the extension section, the enlarged section extends toward the axis of the occlusion device, the extension section and the enlarged section are circumferentially enclosed to form an inner cavity, and the free end of the enlarged section is circumferentially enclosed to form an annular opening connected to the inner cavity. In this way, after the occlusion device is placed in the aneurysm, the extension section is squeezed by the aneurysm wall and fits tightly with the aneurysm wall, and the enlarged section fills the aneurysm cavity. Compared with the occlusion device without the enlarged section, the setting of the enlarged section divides the single chamber into at least two sub-chambers with smaller volumes or multiple sub-chambers connected by narrow channels, the aneurysm neck is blocked by the extension section, and the aneurysm neck is blocked by the extension section. The expansion segment divides the space of the cavity, making the blood flow in the aneurysm slower; in addition, due to the presence of the expansion segment in the aneurysm cavity, it plays a filling role similar to a spring coil, which is conducive to the formation of thrombus; furthermore, the annular opening formed by the circumferential enclosure of the free end of the expansion segment can elastically become smaller when the occlusion device is implanted in the aneurysm and is subjected to radial extrusion force, and can elastically become larger when the aneurysm size increases unexpectedly. On the one hand, the elastic force / support force is transmitted to the extension segment through the expansion segment to provide better support, adapt to the patient's life cycle, and avoid the occlusion device from falling off from the aneurysm neck. On the other hand, the same size of occlusion device can be adapted to multiple aneurysms of different sizes, that is, the same size of occlusion device has different sizes of annular openings when placed in aneurysms of different sizes.

[0028] 2. In the aneurysm occlusion device provided by the present application, the free end of the enlarged section is proximally directed relative to the turning portion. When the occlusion device is squeezed by radial force, the inner side of the enlarged section approaches the extension section, and the outer side surfaces of the enlarged section circumferentially approach each other. The inner side surface of the enlarged section even abuts the extension section, which can provide better support for the extension section and prevent the extension section from excessively deforming inward in the radial direction (i.e., the diameter of the circle formed by the distal end of the extension section becomes smaller) and falling off from the aneurysm neck. In addition, the inner side surface of the enlarged section abuts the extension section, which can form more layers of obstruction for blood at the aneurysm neck, further reducing the entry of blood into the aneurysm cavity, further weakening the vortex phenomenon in the aneurysm cavity and promoting the formation of thrombus. Moreover, the outer side surfaces of the enlarged sections abut each other (at this time, the annular opening moves proximally), which can reduce the flow path of blood from the annular opening to the aneurysm top, reduce the impact force of blood on the aneurysm top, and reduce the risk of aneurysm expansion. The mutual superposition of multiple favorable factors will promote the healing of aneurysms.

[0029] 3. In the aneurysm occlusion device provided in the present application, the free end of the expanded section is directed toward the distal end relative to the turning portion, or the free end of the expanded section is flush with the turning portion. When the occlusion device is squeezed by radial force, the outer surface of the expanded section extends toward the distal end (at this time, the annular opening moves toward the distal end). In this way, the contact area between the occlusion device and the aneurysm wall can be increased. The increase in the contact area can alleviate the pressure of the blood flow entering the aneurysm on the aneurysm wall to a certain extent, preventing the aneurysm from growing further. On the other hand, it can also reduce the size of the cavity formed by the outer surface of the expanded section and the aneurysm top. The smaller the size, the weaker the vortex phenomenon will be, which is conducive to the formation of thrombus in the aneurysm cavity.

[0030] 4. The aneurysm occlusion device provided in the present application, when the occlusion device is squeezed by radial force, the annular opening gradually decreases until it closes, which can block the channel for blood to flow from the inner cavity through the annular opening to the top of the aneurysm, avoid the impact of blood on the top of the aneurysm, and also facilitate the formation of a thrombus at the top of the aneurysm.

[0031] 5. The aneurysm occlusion device provided in the present application has a free end of the expanded section facing proximal relative to the turning portion, and when the occlusion device is not squeezed by radial force, the first conical cavity has a first taper angle; when the occlusion device is squeezed by radial force, the inner side of the expanded section approaches the extension section, and the outer side surfaces of the expanded section approach each other in the circumferential direction, and the first conical cavity has a second taper angle, which is smaller than the first taper angle, or the free end of the expanded section faces distal relative to the turning portion or the free end of the expanded section is flush with the turning portion, and when the occlusion device is not squeezed by radial force The second conical cavity has a third taper angle. When the occluding device is squeezed by radial force, the outer side surface of the expanded section extends toward the distal end. The second conical cavity has a fourth taper angle. The fourth taper angle is smaller than the third taper angle. Since the taper angle of the first conical cavity or the second conical cavity can change with the deformation of the expanded section when the occluding device is squeezed by radial force (the angle of the inner side surface or the outer side surface of the expanded section changes after the occluding device is subjected to radial force), on the one hand, the deformation ability of the expanded section is improved, and on the other hand, the conformability of the occluding device to the tumor cavity is improved.

[0032] The present application also discloses a system for occluding an aneurysm, the system comprising:

[0033] Aneurysm occlusion devices such as those described above, and

[0034] A delivery member or a release member corresponding to the aneurysm occlusion device.

[0035] Optionally, the aneurysm is a wide-necked intracranial bifurcation aneurysm.

[0036] The technical solution of this application has the following advantages:

[0037] The system for occluding an aneurysm provided in the present application has all the advantages of the aforementioned aneurysm occlusion devices. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In order to more clearly illustrate the specific implementation methods of the present application or the technical solutions in the prior art, the following is a brief introduction to the drawings required for use in the specific implementation methods or the description of the prior art. Obviously, the drawings described below are some implementation methods of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0039] FIG1 is a cross-sectional schematic diagram of a blocking device disclosed in Embodiment 1 of the present application;

[0040] FIG2 is a schematic diagram showing the configuration change of the occluding device disclosed in the first embodiment of the present application before and after being subjected to radial compression, wherein the solid line represents the configuration before being subjected to force, and the dotted line represents the configuration after being subjected to force;

[0041] FIG3 is a schematic diagram of the configuration of the occlusion device disclosed in the first embodiment of the present application being radially squeezed within an aneurysm;

[0042] FIG4 is a cross-sectional schematic diagram of the blocking device disclosed in the second embodiment of the present application;

[0043] FIG5 is a schematic diagram of the configuration of the occlusion device in FIG4 being radially squeezed within the aneurysm;

[0044] FIG6 is a front view of the blocking device disclosed in the third embodiment of the present application;

[0045] FIG7 is a perspective schematic diagram of a blocking device disclosed in a third embodiment of the present application;

[0046] FIG8 is a cross-sectional schematic diagram of the blocking device disclosed in Embodiment 3 of the present application;

[0047] FIG9 is a schematic diagram showing the configuration change of the blocking device disclosed in the third embodiment of the present application before and after being subjected to radial compression, wherein the solid line represents the configuration before the force is applied, and the dotted line represents the configuration after the force is applied;

[0048] FIG10 is a schematic diagram of the occlusion device disclosed in the third embodiment of the present application being pressed and gripped in the delivery catheter, and cooperating with the delivery catheter and the push wire;

[0049] FIG11 is a schematic diagram of a portion of the occluding device disclosed in Embodiment 3 of the present application after being pushed out of the delivery catheter;

[0050] FIG12 is a schematic diagram of a smaller-sized occlusion device according to Embodiment 3 of the present application located within a larger-sized aneurysm;

[0051] FIG13 is a schematic diagram of a larger occlusion device according to Embodiment 3 of the present application located within a smaller aneurysm;

[0052] FIG14 is a cross-sectional schematic diagram of a blocking device disclosed in a fourth embodiment of the present application;

[0053] FIG15 is a cross-sectional schematic diagram of the blocking device disclosed in the fifth embodiment of the present application;

[0054] FIG16 is a cross-sectional schematic diagram of the blocking device disclosed in the sixth embodiment of the present application.

[0055] Explanation of the accompanying reference numerals: A, inner cavity; B, outer side surface of the extension section; C, inner side surface of the extension section; X, inner side surface of the expansion section; Y, outer side surface of the expansion section; 1, connecting portion; 3, extension section; 32, turning portion; 4, expansion section; 40, free end; 42, annular opening; 43, first conical cavity; 44, second conical cavity; 45, concave portion of the expansion section; 50, tumor wall; 51, tumor cavity; 52, tumor neck; 53, tumor top; 6, conveying member; 61, push wire; 62, conveying catheter. DETAILED DESCRIPTION

[0056] The following will clearly and completely describe the technical solution of this application in conjunction with the accompanying drawings. Obviously, the embodiments described are only part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of this application.

[0057] In the description of this application, it should be noted that the terms "center," "upper," "vertical," "inner," and "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate and simplify the description of this application. They are not intended to indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed to indicate or imply relative importance. The term "axial" refers to the direction along the centerline of the aneurysm occlusion device.

[0058] In the description of this application, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on the specific circumstances.

[0059] In addition, the technical features involved in the different embodiments of the present application described below can be combined with each other as long as they do not conflict with each other.

[0060] As shown in Figures 1 to 16, the present application provides a system for occluding an aneurysm, comprising an aneurysm occlusion device, a delivery member 6 or a release member corresponding to the aneurysm occlusion device. The aneurysm is a wide-necked aneurysm at an intracranial bifurcation.

[0061] The occluding device has three forms, one is a slender configuration that is constructed with radial compression and suitable for delivery (also referred to as a delivery form), one is an expansion configuration that is elastically transformed from a slender configuration to a radially expanded configuration (also referred to as a free expansion form. In the free expansion form, the occluding device is not squeezed by external forces), and the other is a tumor wall extrusion form. In this embodiment, the occluding device is a double-layer structure obtained by pre-shaping (for example, heat setting, which can be done twice or three or even multiple times) a double-layer braided mesh. The double-layer braided mesh is formed by folding a single-layer braided mesh to form a double-layer structure nested inside and outside. Specifically, one end of the braided wire of the braided mesh extends toward the distal end and then extends toward the proximal end after being folded at the distal end, and both ends of the braided wire are gathered at the gathering section at the proximal end (not shown). The double-layer braided mesh can have 48, 64, 72, 96, 108, or 116 strands. The braided wire diameter can be selected from 0.0006 inches to 0.014 inches, and the braided wire can be made of metal or polymer. In other embodiments, the occlusion device has a single-layer structure, specifically, the single-layer structure is pre-shaped from an elastic tube having a non-uniform wall thickness.

[0062] Regardless of whether the blocking device is single-layer or double-layer, the blocking device is an elastic deformable body, having a radially compressed slender configuration and an expanded configuration that elastically transforms from the slender configuration to a radially expanded configuration, wherein the expanded configuration deforms when subjected to force and returns to its original shape after the external force is removed.

[0063] The occlusion device in the expanded configuration includes a proximal gathering section (not shown; the gathering section is housed within the connecting portion 1), an extension section 3, an expansion section 4 extending from the distal end of the extension section 3, and the connecting portion 1, which are sequentially connected. The extension section 3 and the expansion section 4 circumferentially enclose an inner cavity A. In this embodiment, the extension section 3 extends from a position near the axis toward a direction away from the axis, and the expansion section 4 extends from a position away from the axis toward the axis. The extension section 3 and the expansion section 4 together form a cross-sectional shape similar to "<>".

[0064] The connecting portion 1 fixes and tightens the gathering section, that is, it ties and gathers the ends of the inner and outer braided wires together to prevent the double-layer braided mesh from spreading. The connecting portion 1 can optionally be made of a material that can be developed under X-rays to facilitate positioning. The connecting portion 1 is detachably connected to the push wire 61 so that the occlusion device can be delivered and implanted into the aneurysm. In this embodiment, the inner and outer layers of the extension section 3 are described as being spaced apart from each other or arranged at equal intervals along their length. In other embodiments, the inner and outer layers of the extension section 3 may be in contact with each other along all or part of their length or be arranged at non-equal intervals. Specifically, for example, the inner layer may be pressed radially outward against the outer layer.

[0065] The extension section 3 extends upward from the convergent section and is generally bowl-shaped. Although the extension section 3 in Figures 1 to 4 is depicted as having a proximal arc-shaped bottom (i.e., the area adjacent to the connecting portion 1) (i.e., the bottom is concave when the occluding device is placed vertically), in other embodiments, the bottom can be a distal arc-shaped bottom (i.e., the bottom is convex when the occluding device is placed vertically), or the bottom can be flat. For the convenience of the following description, the junction between the distal end of the extension section 3 and the expanded section 4 is defined as the turning portion 32. In addition, the extension section 3 has an extension section outer side surface B (as shown in Figure 1) and an extension section inner side surface C (as shown in Figure 1).

[0066] The expanded section 4 extends from a position away from the axis toward the axis of the blocking device (as shown by the dotted line in FIG. 1 , FIG. 4 and FIG. 8 ).

[0067] Figures 1 to 3 illustrate a first embodiment of the occlusion device disclosed herein. In this embodiment, the free end 40 of the expanded section 4 is flush with the transition portion 32. The expanded section 4 and the extension section 3 circumferentially enclose an inner cavity A. The free end 40 of the expanded section 4 circumferentially encloses an annular opening 42, which communicates with the inner cavity A. In Figure 1, the expanded section inner surface X of the expanded section 4 is slightly arched toward the distal end, while the expanded section outer surface Y is significantly arched toward the distal end. In Figure 2, the expanded section inner surface X of the expanded section 4 is arched toward the proximal end, while the expanded section outer surface Y is arched toward the distal end. The expanded section inner surface X circumferentially encloses a second tapered cavity 44, which has a third taper angle θ3. Continuing with Figure 2, a comparative view of the occlusion device before and after compression is provided. As can be seen from Figure 2, after compression, the annular opening 42 decreases and moves distally, and the taper angle of the second tapered cavity 44 decreases to a fourth taper angle θ4. In this embodiment, the second tapered cavity 44 is formed by the tangent lines of corresponding points on the inner side surface of the expanded section in the circumferential direction X. In order to compare the change in the taper angle, a fixed point needs to be used as a reference.

[0068] When the occluding device is placed within an aneurysm, as shown in FIG3 , the extension segment 3 occludes the aneurysm neck 52. Due to the size difference (the width of the occluding device in the expanded configuration is greater than the width of the aneurysm), the occluding device is subjected to radially inward compression from the aneurysm wall 50 while providing support for radial outward expansion. Within the aneurysm, when the occluding device is in the aneurysm wall compression configuration, the annular opening 42 becomes smaller or closed compared to the freely deployed configuration. This reduces or even blocks the path for blood to flow through the annular opening 42 toward the aneurysm dome 53, retaining more or even completely the blood within the lumen A, reducing or blocking the impact of blood on the aneurysm dome 53 and preventing further expansion of the aneurysm. Furthermore, the deformation of the annular opening 42 allows the occluding device to adapt to aneurysm cavities 51 of varying sizes. The radially outward force generated by the reduction in the annular opening 42 provides radial support for the occluding device, preventing the extension segment 3 from falling off the aneurysm neck 52 due to insufficient support.

[0069] Figures 4 and 5 show a second embodiment of the occlusion device disclosed in the present application. Referring to Figure 4, the free end 40 of the expanded section 4 faces the distal end relative to the turning portion 32. The free end 40 of the expanded section 4 is circumferentially enclosed to form an annular opening 42. The inner side surface X of the expanded section of the expanded section 4 is arched toward the proximal end, and the outer side surface Y of the expanded section is arched toward the distal end. The inner side surface X of the expanded section is circumferentially enclosed to form a second conical cavity 44, and the second conical cavity 44 has a third taper angle θ3. In this embodiment, the second conical cavity 44 is formed by the tangents of the corresponding points on the circumferential direction of the inner side surface X of the expanded section. In order to compare the change in the taper angle, a fixed point needs to be used as a reference.

[0070] Referring to FIG5 , when the occluding device is placed within an aneurysm, the extended segment 3 seals the aneurysm neck 52. The occluding device contracts radially due to the radial pressure of the aneurysm wall 50, and the outer surface Y of the expanded segment extends distally. This increases the contact area between the occluding device and the aneurysm wall 50, alleviating the pressure exerted by blood entering the aneurysm on the aneurysm wall 50 to a certain extent and preventing further aneurysm growth. Furthermore, the inner surfaces X of the expanded segments circumferentially abut against each other, and the taper angle of the second tapered cavity 44 is correspondingly reduced to a fourth taper angle θ4. The annular opening 42 also becomes smaller, and the inner surfaces X of the expanded segments may even abut against each other, closing the annular opening 42. This further reduces or even blocks the path for blood to flow through the annular opening 42 toward the aneurysm dome 53, retaining more blood, or even completely, within the inner cavity A. This reduces or blocks the impact of blood on the aneurysm wall 50 and dome 53, and prevents further aneurysm expansion. Furthermore, the deformation of the annular opening 42 and the change in the taper angle of the second tapered cavity 44 allow the occlusion device to adapt to aneurysm cavities 51 of varying sizes. The radially outward force generated by the reduction in the annular opening 42 and the decrease in the taper angle of the second tapered cavity 44 provides radial support for the occlusion device, preventing the extension segment 3 from falling out of the aneurysm neck 52 due to insufficient support. Furthermore, in extreme cases, such as when the inner surfaces X of the expanded segments of the occlusion device abut against each other, this can provide even greater radial support for the occlusion device. Furthermore, the proximal arch of the inner surface X of the expanded segment can also provide a component of force that extends the inner surface X toward the distal end, ultimately enhancing the overall occlusion device's deformability and aneurysm conformability.

[0071] Figures 6 to 9 show a third embodiment of the occlusion device disclosed in the present application. In this embodiment, the free end 40 of the expansion section 4 faces the proximal end relative to the turning portion 32. The free end 40 of the expansion section 4 is circumferentially enclosed to form an annular opening 42. The annular opening 42 is connected to the inner cavity A. The inner side surface X of the expansion section of the expansion section 4 is arched toward the proximal end, and the outer side surface Y of the expansion section is arched toward the distal end. Referring to Figure 9, the outer side surface Y of the expansion section is circumferentially enclosed to form a first conical cavity 43, and the first taper angle of the first conical cavity 43 is θ1. In this embodiment, the second conical cavity 44 is formed by the tangent of the corresponding points on the circumferential direction of the outer side surface Y of the expansion section. In order to compare the change in the taper angle, a fixed point is required as a reference.

[0072] Referring to Figure 9 , the configuration change of the occlusion device before and after being subjected to radial compression is exaggerated, with the annular opening 42 becoming smaller and moving proximally. It will be appreciated that Figure 9 also illustrates two configurations of the occlusion device: a freely deployed configuration (shown in solid lines) and a tumor wall compression configuration (shown in dashed lines).

[0073] When the occlusion device is placed within an aneurysm, the extension section 3 seals the aneurysm neck 52. When the occlusion device is subjected to radial compressive force, the free end 40 of the expanded section extends proximally, causing the expanded section inner surface X to gradually move closer to the extension section 3, and the annular opening 42 to move proximally. Simultaneously, the expanded section outer surfaces Y approach each other. When the radial compressive force is sufficiently strong, the expanded section inner surface X abuts the extension section 3, and the expanded section outer surfaces Y abut each other, causing the taper angle of the first tapered cavity 43 to decrease to a second taper angle θ2. This reduces or even blocks the path for blood to flow distally through the annular opening 42, retaining more blood, or even completely, within the inner cavity A, reducing or blocking the impact of blood on the aneurysm wall 50 and preventing further expansion of the aneurysm. Furthermore, the change in the taper angle of the first conical cavity 43 and the deformation of the annular opening 42 allow the occlusion device to adapt to aneurysm cavities 51 of varying sizes. When the annular opening 42 is reduced, its elastic restoring force provides radial support for the occlusion device, preventing the extension segment 3 from falling out of the aneurysm neck 52 due to insufficient support. In particular, when the occlusion device is subjected to significant radial compressive force and the outer surfaces Y of the expanded segments abut against each other, greater radial support is provided. Furthermore, the proximal arch of the inner surface X of the expanded segment allows the expanded segment 4 to quickly abut against the extension segment 3, providing timely radial support to the extension segment 3 and preventing the extension segment 3 from excessively deforming radially inward and falling out of the aneurysm neck 52. Furthermore, the approach of the expanded segment 4 to, or even abutment against, the extension segment 3 creates a multi-layer barrier to blood flow at the aneurysm neck 52, further reducing blood flow into the aneurysm cavity 51 and promoting aneurysm healing. In this embodiment, if the aneurysm is large (as shown in FIG. 12 ), the annular opening 42 does not shrink much; if the aneurysm is small (as shown in FIG. 13 ), the annular opening 42 shrinks more, and the annular opening 42 may even close.

[0074] In the above three embodiments, the deformed distal end of the occluding device does not connect with the tumor top 53 at the top center.

[0075] The following describes the use of the aneurysm occlusion device provided in this embodiment by taking the occlusion device in Embodiment 3 as an example:

[0076] First, the distal end of the delivery catheter 62 is positioned within the aneurysm, and then the push wire 61 is pushed along the delivery catheter 62 to release the occlusion device from the delivery catheter 62 into the aneurysm. A schematic diagram of a partially deployed occlusion device is shown in FIG11 . The occlusion device is completely within the aneurysm. However, due to the restriction of the aneurysm wall 50 , the occlusion device cannot expand to a freely deployed configuration. The extension section 3 of the occlusion device seals the aneurysm neck 52, and the occlusion device remains within the aneurysm cavity 51, in a configuration squeezed by the aneurysm wall. FIG12 and FIG13 respectively show deformation diagrams of the occlusion device under two squeezing degrees.

[0077] After the occluding device is in place, the releasing member releases (can be electrical or mechanical) the connection between the connecting portion 1 and the pushing wire 61, withdraws the pushing wire 61, and then withdraws the delivery catheter 62 to complete the placement of the occluding device.

[0078] Compared with the aneurysm occlusion device without the expansion section, the aneurysm occlusion device provided in this embodiment has the following features: the expansion section 4 is provided to divide a single chamber into at least two smaller sub-chambers or multiple sub-chambers connected by a narrow channel; the aneurysm neck 52 is blocked by the extension section 3; and the expansion section 4 acts as a chamber space divider, so that the blood flow in the aneurysm cavity 51 is slower; in addition, the presence of the expansion section 4 in the aneurysm cavity 51 plays a filling role similar to a spring coil, which is conducive to the formation of thrombus; furthermore, the annular opening formed by the circumferential encirclement of the free end 40 of the expansion section 4 42. When the occluding device is implanted in the aneurysm and subjected to radial squeezing force, the annular opening 42 can elastically become smaller. When the size of the aneurysm increases unexpectedly, the annular opening 42 can elastically become larger. On the one hand, the elastic force / support force is transmitted to the extension section 3 through the expansion section 4 to provide better support, adapt to the patient's life cycle, and avoid the occluding device from falling off from the aneurysm neck 52. On the other hand, the occluding device of the same size can be adapted to multiple aneurysms of different sizes, that is, the occluding device of the same size has annular openings 42 of different sizes when placed in aneurysms of different sizes.

[0079] The aneurysm occlusion device provided in this embodiment simultaneously addresses the requirements for conformability, dense mesh packing within the aneurysm, and increased metal coverage at the aneurysm neck 52. This can further disrupt blood flow changes within the aneurysm, accelerate natural thrombus formation within the aneurysm cavity 51, and improve the timeliness of aneurysm treatment. Furthermore, the aneurysm occlusion device provided in this embodiment is constructed by folding a single-layer braided mesh to form a double-layer braided mesh structure with inner and outer layers nested, followed by secondary heat setting. Compared to a single-layer structure, this configuration provides greater aneurysm support, enhances the stability of the occlusion device within the aneurysm cavity 51, and increases metal coverage at the aneurysm neck 52, further hindering blood flow into the aneurysm cavity 51. Furthermore, the provision of the hollow, enlarged section 4 not only allows for dense metal mesh filling within the aneurysm cavity 51, but also spatially divides the aneurysm cavity 51, increasing resistance to blood flow within the aneurysm, accelerating thrombus formation within the aneurysm cavity 51, and promoting rapid aneurysm healing.

[0080] In addition, referring to Figures 14 to 16, the remaining embodiments of the blocking device are given. Specifically, the blocking device in Figure 14 has two expanded sections 4, and of course, there can be more. The expanded section 4 in Figure 15 is provided with two expanded section recesses 45, and of course, there can be more. The expanded section recess 45 is formed by a partial recess from the expanded section outer side surface Y to the expanded section inner side surface X. There are two expanded sections 4 in Figure 16, and two expanded section recesses 45 are provided on the upper expanded section 4. Of course, in other embodiments, at least one extension section recess can be formed by recessing from the extension section outer side surface B (as shown in 1) of the extension section 3 to the extension section inner side surface C (as shown in Figure 1) to improve the deformation ability of the extension section 3.

[0081] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of this application.

Claims

1. An aneurysm occlusion device, characterized in that: The aneurysm occluding device is constructed to have a slender configuration that is radially compressed and suitable for delivery, and an expanded configuration that is elastically transformed from the slender configuration to a radially expanded configuration. The expanded configuration includes a gathering portion located at the proximal end, an extension section (3), and an expansion section (4) connected to the distal end of the extension section (3) in sequence, the extension section (3) and the expansion section (4) are circumferentially enclosed to form an inner cavity (A), the expansion section (4) extends toward the axis of the occluding device, the expansion section (4) has an inner side surface (X) of the expansion section facing the inner cavity (A) and an outer side surface (Y) of the expansion section facing away from the inner cavity (A), and the free end (40) of the expansion section (4) is circumferentially enclosed to form an annular opening (42) connected to the inner cavity (A).

2. The aneurysm occlusion device according to claim 1, characterized in that: When the blocking device is in an expanded configuration, the extension section (3) extends from a position near the axis toward a direction away from the axis, and the expansion section (4) extends from a position away from the axis toward the axis.

3. The aneurysm occlusion device according to claim 2, characterized in that: The width of the enlarged section (4) extending towards the axis is greater than the height of the enlarged section (4) extending along the axis.

4. The aneurysm occlusion device according to claim 1, characterized in that: When the blocking device is in an expanded configuration, the blocking device is subjected to radial squeezing force, and the annular opening (42) becomes smaller.

5. The aneurysm occlusion device according to claim 4, characterized in that: The annular opening (42) moves toward the proximal end or the distal end.

6. The aneurysm occlusion device according to claim 1, characterized in that: When the blocking device is in a non-slender configuration, the outer side surface (Y) of the expanded section circumferentially encloses a first conical cavity (43), the tip of which faces the proximal end and is connected to the annular opening (42), or the inner side surface (X) of the expanded section circumferentially encloses a second conical cavity (44), the tip of which faces the distal end and is connected to the annular opening (42).

7. The aneurysm occlusion device according to claim 6, characterized in that: The portion of the extension section (3) connected to the enlarged section (4) is a turning portion (32). In a direction parallel to the axis of the occluding device, the free end (40) of the enlarged section (4) faces the proximal end relative to the turning portion (32), or the free end (40) of the enlarged section (4) faces the distal end relative to the turning portion (32), or the free end (40) of the enlarged section (4) is flush with the turning portion (32).

8. The aneurysm occlusion device according to claim 7, characterized in that: The free end (40) of the expanded section (4) faces the proximal end relative to the turning portion (32), and when the blocking device is squeezed by radial force, the inner side surface (X) of the expanded section approaches the extension section (3), and the outer side surfaces (Y) of the expanded section approach each other in the circumferential direction.

9. The aneurysm occlusion device according to claim 8, characterized in that: When the blocking device is not squeezed by radial force, the first conical cavity (43) has a first taper angle, and when the blocking device is squeezed by radial force, the first conical cavity (43) has a second taper angle, and the second taper angle is smaller than the first taper angle.

10. The aneurysm occlusion device according to claim 7, characterized in that: The free end (40) of the expanded section (4) faces the distal end relative to the turning portion (32), or the free end (40) of the expanded section (4) is flush with the turning portion (32), and when the blocking device is squeezed by radial force, the outer side surface (Y) of the expanded section extends toward the distal end.

11. The aneurysm occlusion device according to claim 10, characterized in that: When the blocking device is not squeezed by radial force, the second conical cavity (44) has a third taper angle, and when the blocking device is squeezed by radial force, the second conical cavity (44) has a fourth taper angle, and the fourth taper angle is smaller than the third taper angle.

12. The aneurysm occlusion device according to any one of claims 8 to 11, characterized in that: When the blocking device is squeezed by radial force, the annular opening (42) is closed.

13. The aneurysm occlusion device according to claim 1, characterized in that: The inner side surface (X) of the expanded section and the outer side surface (Y) of the expanded section are both arcuate surfaces, both arched toward the distal end, or the inner side surface (X) of the expanded section arches toward the proximal end, and the outer side surface (Y) of the expanded section arches toward the distal end.

14. The aneurysm occlusion device according to claim 1, characterized in that: The blocking device is a single-layer structure obtained by pre-shaping an elastic tube body with non-uniform wall thickness, or the blocking device is a double-layer structure obtained by pre-shaping a double-layer mesh tube.

15. The aneurysm occlusion device according to claim 1, characterized in that: The number of the expanded sections (4) is at least two, and at least two of the expanded sections (4) are arranged vertically spaced apart along the axial direction.

16. The aneurysm occlusion device according to claim 1, characterized in that: The enlarged section outer side surface (Y) of the enlarged section (4) is partially recessed toward the enlarged section inner side surface (X), or the enlarged section inner side surface (X) is partially recessed toward the enlarged section outer side surface (Y) to form at least one enlarged section recessed portion (45), and / or, The outer side surface (B) of the extension section (3) faces the inner side surface (C) of the extension section, or the inner side surface (C) of the extension section (3) is partially recessed toward the outer side surface (B) of the extension section to form at least one extension section recessed portion.

17. A system for occluding an aneurysm, the system comprising: The aneurysm occlusion device according to any one of claims 1 to 16, and A delivery member (6) or a release member corresponding to the aneurysm occlusion device.

18. The system for occluding an aneurysm according to claim 17, characterized in that: The aneurysm is a wide-necked aneurysm at the intracranial bifurcation.

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