Aneurysm occlusion apparatus and system for occluding aneurysm

Abstract

An aneurysm occlusion apparatus and a system for occluding an aneurysm. The occlusion apparatus is configured to have an elongated configuration and an expanded configuration elastically transformed from the elongated configuration to radial expansion. The expanded configuration comprises a gathering portion, an extension section (3), and an expansion section (4), which are connected in sequence, the expansion section being connected to a tail end of the extension section (3). The extension section (3) is circumferentially enclosed to form an inner cavity (A). The extension section (3) comprises at least one inflection unit. The inflection unit comprises a first section (31) extending in a direction away from the axis, and a second section (32) extending in an inflection manner from a far end of the first section (31) to the axial direction. The expansion section (4) extends from a tail end of the second section (32) to the direction away from the axis. The second section (32) and the axis are arranged at intervals, so that a turning part (41) connected to the second section (32) on the expansion section (4) is circumferentially enclosed to form an annular opening (42), and the annular opening (42) is in communication with the inner cavity (A). The extension section (3) can occlude an aneurysm neck opening and is tightly attached to a tumor wall, and the expansion section (4) fills a tumor cavity, thereby reducing blood flow from a parent artery to an aneurysm top, facilitating thrombosis and aneurysm healing, and preventing the occlusion apparatus from falling off from the aneurysm neck opening.

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 January 18, 2024, with application number 202410077551.1 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, the occlusion device is constructed to have a slender configuration that is radially compressed to extend along an axis and is suitable for delivery, and an expansion configuration that elastically transforms from the slender configuration into a radially expanded configuration, the expansion configuration includes a gathering portion located at the proximal end, an extension segment, and an enlarged segment connected to the end of the extension segment, which are connected in sequence, the extension segment circumferentially encloses an inner cavity, the extension segment includes at least one folding unit, the folding unit includes a first segment extending in a direction away from the axis, and a second segment folded back and extended from the distal end of the first segment in the direction of the axis, the enlarged segment extends from the end of the second segment in a direction away from the axis, and the second segment is spaced apart from the axis so that the turning portion on the enlarged segment connected to the second segment circumferentially encloses a ring-shaped opening, and the ring-shaped opening is connected to the inner cavity.

[0010] Optionally, the width of the extension section is greater than the width of the expanded section, and the width direction is perpendicular to the axis.

[0011] Optionally, the width of the expanded section is greater than the height of the expanded section, the width direction is a direction perpendicular to the axis, and the height direction is a direction parallel to the axis.

[0012] Optionally, when the occluding device is in the expanded configuration, when the occluding device is squeezed by a radial force, the annular opening moves toward the proximal end or the distal end.

[0013] Optionally, when the blocking device is in a non-slender configuration, the expanded section includes an expanded section inner surface and an expanded section outer surface, the expanded section inner surface faces the extension section, and the expanded section outer surface faces away from the extension section, and a conical cavity is formed, the tip of the conical cavity faces the proximal end and is connected to the annular opening.

[0014] Optionally, in a direction parallel to the axis, the free end of the expanded section faces the proximal end relative to the turning portion, or the free end of the expanded section is adjacent to the distal end relative to the turning portion, or the free end of the expanded section is flush with the turning portion.

[0015] Optionally, the free end of the expanded section is adjacent to the proximal end relative to the turning portion, or the free end of the expanded section is flush with the turning portion. When the sealing device is squeezed by radial force, the inner surface of the expanded section and the second section approach each other, and the outer surfaces of the expanded section radially move away from each other.

[0016] Optionally, the free end moves toward the proximal end and the turning portion moves toward the distal end, causing the expanded section to be everted.

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

[0018] Optionally, the free end of the expanded section is adjacent to the distal end relative to the turning portion, and when the blocking device is squeezed by radial force, the inner surface of the expanded section and the second section of the extension section approach each other, and the outer surfaces of the expanded section radially approach each other.

[0019] Optionally, when the blocking device is squeezed by radial force, the outer surfaces of the expanded sections fit together.

[0020] Optionally, when the blocking device is not squeezed by radial force, the conical cavity has a first taper angle; when the blocking device is squeezed by radial force, the turning portion moves toward the proximal end, and the conical cavity has a second taper angle, which is smaller than the first taper angle.

[0021] Optionally, the turning portion moves toward the proximal end and the enlarged section turns inward.

[0022] Optionally, the inner surface of the expanded section and the outer surface of the expanded section are both arc-shaped surfaces, the inner surface of the expanded section is arched toward the proximal end, and the outer surface of the expanded section is arched toward the distal end.

[0023] 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.

[0024] The technical solution of this application has the following advantages:

[0025] 1. The aneurysm occlusion device provided in the present application is constructed to have a slender configuration that is radially compressed to extend along the axis and is suitable for delivery, and an expanded configuration that elastically changes from the slender configuration to radially expand, the expanded configuration includes a gathering portion at the proximal end, an extension segment, and an enlarged segment connected to the end of the extension segment, which are connected in sequence, the extension segment circumferentially encloses an inner cavity, the extension segment includes at least one fold unit, the fold unit includes a first segment extending in a direction away from the axis, and a second segment extending from the distal end of the first segment in the direction of the axis, the enlarged segment extends from the end of the second segment in a direction away from the axis, the second segment is spaced apart from the axis so that the turning portion connected to the second segment on the enlarged segment circumferentially encloses to form an annular opening, and the annular opening is connected to the inner cavity. In this way, after the occlusion device is placed in the aneurysm, the first segment on the fold unit of the extension segment is squeezed by the aneurysm wall and fits tightly against the aneurysm wall, and the enlarged segment fills the aneurysm cavity, which is more effective than that without the closure device. For the occlusion device with an expansion section, the expansion section divides a single chamber into at least two sub-chambers with smaller volumes or multiple sub-chambers connected by a narrow channel, the neck of the aneurysm is blocked by the extension section, and the expansion section divides the chamber space, so that the blood flow in the aneurysm cavity is slower; in addition, due to the presence of the expansion section 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 encirclement of the turning part connected to the second section on the expansion section can change accordingly when the occlusion device is implanted in the aneurysm and subjected to radial extrusion force. On the one hand, the elastic force / support force is transmitted to the extension section through the expansion section to provide better support, adapt to the patient's life cycle, and avoid the occlusion device from falling off from the neck of the aneurysm. On the other hand, the occlusion device of the same size can be adapted to multiple aneurysms of different sizes, that is, the occlusion device of the same size can adapt to aneurysms of different sizes.

[0026] 2. In the aneurysm occlusion device provided in the present application, the width of the extension section is greater than the width of the expansion section in the width direction perpendicular to the axis. In this way, the extension section contacts the aneurysm wall before the expansion section. The expansion section contacts the aneurysm wall only after the extension section is deformed, so that the extension section can better contact the aneurysm wall and better stabilize in the aneurysm cavity, thereby avoiding the aneurysm neck being exposed due to the smaller size of the extension section and affecting the blood flow in the blood vessel.

[0027] 3. The aneurysm occlusion device provided in the present application has an enlarged section whose width is greater than its height, with the width direction being perpendicular to the axis and the height direction being parallel to the axis, so that the enlarged section is flatter as a whole, thereby giving the aneurysm occlusion device better radial support performance.

[0028] 4. In the aneurysm occlusion device provided herein, the free end of the expanded segment is located distally relative to the turning portion. When the occlusion device is subjected to radial force, the expanded segment inverts inwardly. Specifically, the inner surface of the expanded segment approaches the second segment of the extended segment, and the outer surfaces of the expanded segment radially abut each other, with the inner surface of the expanded segment even abutting the second segment. This provides better support for the extended segment, preventing the extended segment from excessively deforming inward in the radial direction (i.e., decreasing the diameter of the circle formed by the distal end of the extended segment) and falling off the aneurysm neck. Furthermore, the abutment between the inner surface of the expanded segment and the extended segment creates an additional barrier to blood flow at the neck, further reducing blood ingress into the aneurysm cavity and further attenuating vortex flow within the aneurysm cavity, which promotes thrombus formation. Furthermore, the abutment, or even contact, of the outer surfaces of the expanded segments (at this time, the annular opening moves proximally), shortening the blood flow path from the annular opening to the aneurysm dome, reducing the impact force of blood on the aneurysm dome, and lowering the risk of aneurysm enlargement. The combination of these multiple favorable factors promotes aneurysm healing.

[0029] 5. In the aneurysm occlusion device provided in the present application, the free end of the expanded section is close to the proximal 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 expanded section is everted, specifically, the inner surface of the expanded section and the second section are close to each other, and the outer surfaces of the expanded section are radially away from each other. In some cases, the outer surface of the expanded section can fit with the aneurysm wall. In this way, the fitting area between the occlusion device and the aneurysm wall can be increased. The increase in the fitting area can alleviate the pressure of the blood flow entering the aneurysm on the aneurysm wall to a certain extent, thereby protecting the aneurysm wall and preventing the aneurysm from further growing.

[0030] 6. In the aneurysm occlusion device provided in the present application, the free end of the enlarged section is directed distally relative to the turning portion. When the occlusion device is not squeezed by radial force, the conical cavity has a first taper angle. When the occlusion device is squeezed by radial force, the turning portion moves proximally, and the conical cavity has a second taper angle. The second taper angle is smaller than the first taper angle, and the outer surface of the enlarged section is even radially close to each other. In this way, the channel for blood to flow from the inner cavity through the annular opening to the aneurysm top can be reduced or even blocked, thereby avoiding the impact of blood on the aneurysm top and facilitating the formation of a thrombus at the aneurysm top.

[0031] 7. The aneurysm occlusion device provided in the present application is in an expanded configuration. When the occlusion device is squeezed by radial force, the annular opening moves toward the proximal or distal end. In this way, on the one hand, the deformation ability of the expanded section is improved, and on the other hand, the conformability of the occlusion device to the aneurysm cavity is improved.

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

[0033] The aforementioned aneurysm occlusion device, 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 of the occlusion device in FIG1 being radially squeezed within an aneurysm;

[0041] FIG3 is a cross-sectional schematic diagram of the blocking device disclosed in the second embodiment of the present application;

[0042] FIG4 is a schematic diagram of the configuration of the occlusion device in FIG3 being radially squeezed within the aneurysm;

[0043] FIG5 is a cross-sectional schematic diagram of the blocking device disclosed in the third embodiment of the present application;

[0044] FIG6 is a schematic diagram of the occlusion device in FIG5 being radially squeezed within the aneurysm;

[0045] FIG7 is a cross-sectional schematic diagram of the blocking device disclosed in the fourth embodiment of the present application;

[0046] FIG8 is a schematic diagram of the occlusion device in FIG7 being radially squeezed in an aneurysm.

[0047] Explanation of the accompanying reference numerals: A, inner cavity; X, inner surface of the expanded section; Y, outer surface of the expanded section; 1, connecting portion; 3, extension section; 31, first section; 32, second section; 4, expanded section; 40, free end; 41, turning portion; 42, annular opening; 43, conical cavity; 50, tumor wall; 51, tumor cavity; 52, tumor neck; 53, tumor top. DETAILED DESCRIPTION

[0048] 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.

[0049] 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" and "second" 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.

[0050] 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.

[0051] 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.

[0052] As shown in Figures 1 to 8, the present application provides a system for occluding an aneurysm, comprising an aneurysm occluding device and a delivery member or a release member corresponding to the aneurysm occluding device. The aneurysm is a wide-necked aneurysm at an intracranial bifurcation.

[0053] The occluding device has three forms. One is a slender configuration that is constructed with radial compression and axial extension suitable for delivery (also referred to as a delivery form), one is an expanded configuration that elastically transforms from a slender configuration to a radially expanded configuration (also referred to as a free deployment form. In the free deployment form, the occluding device is not squeezed by external forces), and the other is an aneurysm wall squeezing form (the occluding device is squeezed by the aneurysm wall when it expands from a slender configuration to an expanded configuration within the aneurysm, and the volume of the aneurysm changes after the occluding device is implanted within the aneurysm, and is squeezed or partially expanded by the aneurysm). In this embodiment, the occluding device is a double-layer structure obtained by pre-shaping (for example, heat setting, which can be done twice, three times, or even more 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.

[0054] 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.

[0055] The occlusion device in its expanded configuration includes a connecting portion 1, a gathering section (not shown; the gathering section is housed within the connecting portion 1), an extension section 3, and an enlarged section 4 extending from the distal end of the extension section 3. The gathering section is located at the proximal end. The extension section 3 circumferentially encloses an inner cavity A.

[0056] For ease of explanation, the junction of the expanded section 4 and the extension section 3 is defined as the turning portion 41. The surface of the expanded section 4 facing the extension section 3 is the expanded section inner surface X, and the surface facing away from the extension section 3 is the expanded section outer surface Y. The tapered cavity 43 is formed by the tangent lines of corresponding points on the circumference of the expanded section outer surface Y. To compare changes in the taper angle, a fixed point is used as a reference.

[0057] Connector 1 secures and tightens the gathered section, effectively tying the ends of the inner and outer braided wires together to prevent the double-layer braided mesh from unraveling. Connector 1 can optionally be constructed of an X-ray-visible material for easier positioning. Connector 1 is detachably connected to push wire 61, facilitating delivery and implantation of the occlusion device within the aneurysm.

[0058] The extension section 3 includes at least one folding unit. The folding unit includes a first section 31 extending away from the axis and a second section 32 folding back from the distal end of the first section 31 toward the axis. The provision of the folding unit can form at least two layers of blood blocking effect. In addition, the bottom first section of the extension section 3 extends upward from the gathering section, and the circumferential enclosed bottom first section is generally bowl-shaped. Although the extension section 3 is depicted in Figures 3 to 8 as having a bottom (i.e., the area near the connection with the connecting portion 1) that is arc-shaped and protrudes toward the proximal end (i.e., the bottom is concave when the occluding device is placed vertically), in other embodiments, the bottom can be arc-shaped and protrudes toward the distal end (i.e., the bottom is convex when the occluding device is placed vertically), or the bottom can be flat. The bottom first section here refers to the first section 31 near the proximal end. If there is only one folding unit, there is no dispute. If there are two or more folding units, the bottom first section is the first section 31 near the proximal end. In this embodiment, the inner layer and the outer layer 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 layer and the outer layer of the extension section 3 may be in contact with each other or arranged at non-equal intervals along all or part of their length. Specifically, for example, the inner layer may be pressed radially outward against the outer layer.

[0059] In particular, the width of the extension section 3 is greater than the width of the expansion section 4, and the width direction is perpendicular to the axis. In this way, the extension section 3 contacts the tumor wall 50 before the expansion section 4. After the extension section 3 is deformed, the expansion section 4 contacts the tumor wall, so that the extension section 3 can better contact the tumor wall 50 and be better stabilized in the tumor cavity, avoiding the tumor neck 52 being exposed due to the small size of the extension section 3 and affecting the flow of blood in the blood vessel.

[0060] The expanded section 4 is formed by folding outward from the end of the second section 32. The second section 32 is spaced apart from the axis so that the turning portion 41 on the expanded section 4 connected to the second section 32 is circumferentially enclosed to form an annular opening 42, which is connected to the inner cavity A.

[0061] In particular, the width of the expanded segment 4 is greater than the height of the expanded segment 4, the width direction is perpendicular to the axis, and the height direction is parallel to the axis, making the expanded segment 4 flatter as a whole, thereby making the aneurysm occlusion device have better radial support performance.

[0062] When the occluding device is placed within an aneurysm, the extension segment 3 occludes the aneurysm neck 52 (as shown in Figures 2, 4, 6, and 8). The width of the occluding device in its expanded configuration is greater than the width of the aneurysm, causing the occluding device to be squeezed within the aneurysm. While being subjected to radially inward squeezing force from the aneurysm wall 50, the occluding device can also provide radially outward expansion support. 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 (as shown in Figures 2, 4, 6, and 8) due to insufficient support.

[0063] Figures 1 and 2 illustrate a first embodiment of the occlusion device disclosed in this application. In this embodiment, the free end 40 of the expanded section 4 is located distally relative to the transition portion 41. As shown in Figure 1 , the expanded section 4 has an inner surface X that arches toward the proximal end, while an outer surface Y that arches toward the distal end. Furthermore, the expanded section outer surface Y circumferentially encloses a tapered cavity 43. Of course, the expanded section inner surface X can also be designed to arch toward the distal end or be straight.

[0064] When the blocking device is not subjected to radial force, the tapered cavity 43 has a first tapered angle.

[0065] When the occluding device is subjected to radial force, a comparison of Figure 2 with Figure 1 shows that the entire expanded section 4 turns inward, and the turning portion 41 moves toward the proximal end while moving away from the axis, causing the annular opening 42 to gradually increase, the angle between the free end 40 and the axis to gradually decrease, and the expanded section outer surfaces Y gradually approach each other, even fitting together, and further abutting each other. The tapered cavity 43 has a second taper angle that is smaller than the first taper angle. In addition, the first section 31 of the extension section 3 is deformed into an arc shape by the aneurysm wall, and the second section 32 is also deformed into an arc shape by the compression of the expanded section inner surface X, as shown in Figure 2.

[0066] During the extrusion deformation process, although the annular opening 42 gradually increases in size, the outer surfaces Y of the expanded segments gradually approach each other radially, even fitting together, and further abutting each other. This reduces or even blocks the passage of blood from the inner cavity through the annular opening to the tumor dome, preventing blood from impacting the tumor dome and facilitating thrombus formation at the tumor dome. Furthermore, when the outer surfaces Y of the expanded segments fit together, the radial support force of the expanded segment 4 on the extension segment 3 is enhanced. Furthermore, during the extrusion deformation process, the elastic recovery force of the expanded segment 4 can also provide radial support for the extension segment 3.

[0067] Figures 3 and 4 illustrate a second embodiment of the occlusion device disclosed herein. The primary difference between this embodiment and the first embodiment lies in the increased angle between the second segment 32 and the first segment 31. This can be understood as a variation on the first embodiment, where the second segment 32 is raised relative to the first segment 31, causing the free end of the expanded segment 4 to move proximally, and the free end 40 of the expanded segment 4 to align with the transition portion 41. "Aligned" here means that the free end 40 and the transition portion 41 are located on the same straight line, perpendicular to the axis of the occlusion device. Furthermore, both the first segment 31 and the second segment 32 are arched proximally.

[0068] When the blocking device is not subjected to radial force, the tapered cavity 43 has a first tapered angle.

[0069] When the occluding device is squeezed by radial force, the aneurysm wall first squeezes the first section 31, further increasing the angle between the second section 32 and the first section 31 and causing the turning portion 41 to move distally. Accordingly, the annular opening 42 also moves distally. At the same time, the outer surface Y of the expanded section is also squeezed by the aneurysm top 53 and the aneurysm wall 50, causing the inner surface X of the expanded section and the second section 32 of the extension section 3 to approach each other or even abut each other. The outer surface Y of the expanded section moves radially away from each other, the expanded section 4 is turned outward, the annular opening 42 gradually decreases, and the tapered cavity 43 has a second taper angle, which is greater than the first taper angle.

[0070] During the extrusion deformation process, the annular opening 42 gradually decreases and even closes. This 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 the aneurysm dome 53, and also facilitates the formation of a thrombus at the aneurysm dome. Furthermore, the outward-facing expansion segment 4 increases the contact area between the expansion segment 4 and the aneurysm wall, which can alleviate the pressure of blood entering the aneurysm on the aneurysm wall 50 to a certain extent and prevent further growth of the aneurysm. Furthermore, since both the expansion segment 4 and the extension segment 3 are in contact with the aneurysm wall 50, the stability of the occlusion device within the aneurysm cavity 51 can be improved. Furthermore, during the extrusion deformation process, the elastic restoring force of the expansion segment 4 can also provide radial support for the extension segment 3.

[0071] Figures 5 and 6 illustrate a third embodiment of the occlusion device disclosed in this application. The primary difference between the third embodiment and the second embodiment is that the angle between the second section 32 and the first section 31 is further increased. This can be understood as, based on the second embodiment, further lifting the second section 32 relative to the first section 31, driving the free end 40 of the expanded section 4 to continue moving proximally, bringing the free end 40 of the expanded section 4 closer to the proximal end relative to the turning portion 41. Furthermore, the first section 31 arches toward the proximal end, while the second section 32 arches toward the distal end, allowing the second section 32 to better contact the inner surface X of the expanded section, thereby enhancing the mutual support between the extension section 3 and the expanded section 4.

[0072] When the blocking device is not subjected to radial force, the tapered cavity 43 has a first tapered angle.

[0073] When the occluding device is squeezed by radial force, as shown in FIG6 , the aneurysm wall 50 first squeezes the first section 31 of the extension section 3, further increasing the angle between the second section 32 and the first section 31, and causing the turning portion 41 to move toward the distal end. Accordingly, the annular opening 42 also moves toward the distal end. At the same time, the outer surface Y of the expanded section is squeezed by the aneurysm top 53 and the aneurysm wall 50, causing the inner surface X of the expanded section and the second section 32 of the extension section 3 to approach each other or even abut each other, while the outer surface Y of the expanded section moves radially away from each other, the expanded section 4 is turned outward, and the annular opening 42 gradually decreases. During this process, the tapered cavity has a second taper angle, which is greater than the first taper angle.

[0074] During the extrusion deformation process, the annular opening 42 gradually decreases or even closes. This can reduce or even block 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 the aneurysm dome 53, and also facilitates the formation of a thrombus at the aneurysm dome. Furthermore, due to the outward rotation of the expanded segment 4, the contact area between the expanded segment 4 and the aneurysm wall increases, which can alleviate the pressure of blood flow entering the aneurysm on the aneurysm wall 50 to a certain extent and prevent the aneurysm from growing further. Furthermore, since both the expanded segment 4 and the extension segment 3 are in contact with the aneurysm wall 50, the stability of the occlusion device within the aneurysm cavity 51 can be improved. Furthermore, during the extrusion deformation process, the elastic recovery force of the expanded segment 4 can also provide radial support for the extension segment 3.

[0075] Figures 7 to 8 show the fourth embodiment of the occluding device disclosed in the present application. The main difference between the fourth embodiment and the first embodiment is that there are two folding units. Of course, there can also be three or even more. The setting of multiple folding units can improve the blocking effect of the occluding device on blood flow.

[0076] In the above four embodiments, the deformed distal end of the occluding device does not abut against the tumor top 53 at the top center.

[0077] Compared with the occluding device without the expansion section, the occluding device for the aneurysm 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 neck of the aneurysm 52 is blocked by the extension section 3; and the expansion section 4 divides the chamber space, 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 turning portion 41 circumferentially encloses a ring-shaped opening 42, which is surrounded by the diameter of the aneurysm when the occluding device is implanted in the aneurysm. When the squeezing pressure is applied, the annular opening 42 can be elastically deformed. Specifically, the annular opening 42 can be enlarged or reduced, and can also move proximally or distally. When the size of the aneurysm increases unexpectedly, the annular opening 42 can be elastically enlarged. 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 occlusion device from falling off from the aneurysm neck 52. On the other hand, the occlusion device of the same size can be adapted to multiple aneurysms of different sizes, that is, the occlusion device of the same size has annular openings 42 of different sizes when placed in aneurysms of different sizes.

[0078] 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.

[0079] 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 plugging device is configured to have a radially compressed elongated configuration suitable for conveying along an axis, and elastically transform from the elongated configuration to a radially expanded expanded configuration. The expanded configuration includes a converging portion at the proximal end, an extension section (3), and an enlarged section (4) connected to the end of the extension section (3) in sequence. The extension section (3) circumferentially encloses to form an inner cavity (A). The extension section (3) includes at least one folding unit. The folding unit includes a first section (31) extending away from the axis and a second section (32) folding and extending from the distal end of the first section (31) towards the axis. The enlarged section (4) extends away from the axis from the end of the second section (32). The second section (32) is spaced from the axis such that a turning portion (41) on the enlarged section (4) connected to the second section (32) circumferentially encloses to form an annular opening (42), and the annular opening (42) communicates with the inner cavity (A).

2. The aneurysm occlusion device according to claim 1, wherein The width of the extension section (3) is greater than the width of the enlarged section (4), and the width direction is perpendicular to the axis.

3. The aneurysm occlusion device according to claim 1, wherein, The width value of the enlarged section (4) is greater than the height value of the enlarged section (4), the width direction is perpendicular to the axis, and the height direction is parallel to the axis.

4. The aneurysm occlusion device according to claim 1, characterized in that, When the plugging device is in the expanded configuration, when the plugging device is subjected to a radial force extrusion, the annular opening (42) moves towards the proximal end or the distal end.

5. The aneurysm occlusion device according to claim 1, wherein, When the plugging device is in a non-elongated configuration, the enlarged section (4) includes an inner surface (X) of the enlarged section and an outer surface (Y) of the enlarged section. The inner surface (X) of the enlarged section faces the extension section (3), and the outer surface (Y) of the enlarged section faces away from the extension section (3), and circumferentially encloses to form a tapered cavity (43). The tip of the tapered cavity (43) faces the proximal end and communicates with the annular opening (42).

6. The aneurysm occlusion device according to claim 5, wherein, In the direction parallel to the axis, the free end (40) of the enlarged section (4) is adjacent to the proximal end relative to the turning portion (41), or the free end (40) of the enlarged section (4) is adjacent to the distal end relative to the turning portion (41), or the free end (40) of the enlarged section (4) is flush with the turning portion (41).

7. The aneurysm occlusion device according to claim 6, characterized in that, The free end (40) of the enlarged section (4) is adjacent to the proximal end relative to the turning portion (41), or the free end (40) of the enlarged section (4) is flush with the turning portion (41). When the plugging device is subjected to a radial force extrusion, the inner surface (X) of the enlarged section and the second section (32) approach each other, and the outer surfaces (Y) of the enlarged section move radially away from each other.

8. The aneurysm occlusion device according to claim 7, wherein The free end (40) moves towards the proximal end, and the turning portion (41) moves towards the distal end, causing the enlarged section (4) to turn outwards.

9. The aneurysm occlusion device according to claim 7, wherein When the plugging device is not subjected to a radial force extrusion, the tapered cavity (43) has a first taper angle. When the plugging device is subjected to a radial force extrusion, the tapered cavity (43) has a second taper angle, and the second taper angle is greater than the first taper angle.

10. The aneurysm occlusion device according to claim 6, characterized in that, The free end (40) of the enlarged section (4) is adjacent to the distal end relative to the turning portion (41). When the occlusion device is radially squeezed, the inner surface (X) of the enlarged section approaches the second section (32) of the extension section (3), and the outer surfaces (Y) of the enlarged section approach each other radially.

11. The aneurysm occlusion device according to claim 10, wherein, When the occlusion device is radially squeezed, the outer surfaces (Y) of the enlarged section fit together.

12. The aneurysm occlusion device according to claim 10, characterized in that, The turning portion (41) moves towards the proximal end, causing the enlarged section (4) to turn inwards.

13. The aneurysm occlusion device according to claim 10, characterized in that, When the occlusion device is not radially squeezed, the conical cavity (43) has a first taper angle. When the occlusion device is radially squeezed, the turning portion (41) moves towards the proximal end, and the conical cavity (43) has a second taper angle, and the second taper angle is smaller than the first taper angle.

14. The aneurysm occlusion device according to claim 5, characterized in that, Both the inner surface (X) and the outer surface (Y) of the enlarged section are arc-shaped surfaces. The inner surface (X) of the enlarged section arches towards the proximal end, and the outer surface (Y) of the enlarged section arches towards the distal end.

15. The aneurysm occlusion device according to claim 1, characterized in that, The occlusion device is a single-layer structure, and the single-layer structure is pre-shaped from an elastic tube body with a non-uniform wall thickness, or the occlusion device is a double-layer structure, and the double-layer structure is pre-shaped from a double-layer network tube.

16. A system for occluding an aneurysm, the system comprising: The aneurysm occlusion device according to any one of claims 1-15, and A delivery member or a detachment member corresponding to the aneurysm occlusion device.

17. The system for occluding an aneurysm according to claim 16, wherein The aneurysm is a wide-neck aneurysm at the intracranial bifurcation.

Images