Aneurysm occlusion device and system for occluding aneurysms

Abstract

Disclosed are an aneurysm occlusion device and a system for occluding an aneurysm, wherein the aneurysm occlusion device is configured to have a radially compressible and transportable elongated structure and an expandable structure that elastically deforms radially from the elongated structure, the expandable structure comprising a converging section located at the proximal end, an extension segment, and an ambulatory segment connected to the distal end of the extension segment, the ambulatory segment extending toward the axis of the occlusion device, the extension segment and the ambulatory segment circumferentially enclosing each other to form a lumen, the free end of the ambulatory segment circumferentially enclosing each other to form an annular opening communicating with the lumen. When the occlusion device is placed in an aneurysm, the extension segment occludes the aneurysm neck and adheres tightly to the aneurysm wall, the ambulatory segment fills the aneurysm lumen and reduces blood flow from the carrier artery to the aneurysm apex, thereby slowing the blood flow within the aneurysm lumen, which is advantageous for thrombus formation and aneurysm healing, and preventing the occlusion device from detaching from the aneurysm neck.

Description

Technical Field

[0001] (Cross - reference to Related Applications) This application claims the priority of a Chinese patent application with application number 202311615817.5 and invention title "Aneurysm Occlusion Device and System for Occluding Aneurysm" filed with the China National Intellectual Property Administration on November 29, 2023, the entire content of which is incorporated herein by reference.

[0002] This application relates to the technical field of occlusion devices, specifically to an aneurysm occlusion device and a system for occluding aneurysms.

Background Art

[0003] Intracranial aneurysms are common intracranial diseases. The incidence rate of aneurysms is about 7% - 9%. The presence of intracranial aneurysms in the human body poses a significant risk to people. When an aneurysm ruptures, it can cause hemorrhagic stroke, leading to unconsciousness in the patient and even life - threatening in some cases, posing a serious threat to people's health.

[0004] Currently, treatment methods for aneurysms mainly include surgical clipping, the combined use of coils and auxiliary stents, and intra-aneurysmal disruption braided structures. Of these, surgical clipping carries extremely high surgical risks and high surgical costs, placing a significant financial and psychological burden on patients. The combined use of coils and auxiliary stents is a relatively good aneurysm interventional treatment method, but it is not suitable for treating platycaro artery aneurysms at bifurcations. For bifurcated platycaro artery aneurysms, a lantern-shaped intra-aneurysmal disruption braided structure has been proposed by a company and has shown some clinical effectiveness, but it also has many limitations. One of these is that the lantern-shaped configuration hinders its adaptability to various aneurysms, requiring the design of many specifications and models to suit various aneurysms, resulting in low adaptability. Subsequently, another typical occlusion device similar to an open bowl shape has been designed by another company and is mainly used to occlude the neck of the aneurysm. Because it is designed to be open, it is only necessary to consider the size of the aneurysm neck, without considering the shape of the aneurysm. With the same specifications, it can be suitable for aneurysms within a certain range, improving adaptability, and the one-year aneurysm occlusion rate is close to that of the former. However, in bowl-shaped occlusion devices, the high-density metal mesh is distributed only to the aneurysm neck, and there is no filling material inside the aneurysm. Due to the inevitable blood that passes through the occlusion device and / or the vortices present inside the aneurysm, the cycle in which blood forms a thrombus within the aneurysm may be longer compared to occlusion devices with filling material. Also, bowl-shaped occlusion devices lack a support and adhere to the aneurysm wall only by the bowl-shaped side walls, which may pose a risk of long-term dislodgement.

[0005] Therefore, in order to solve the above problems, it is necessary to design an aneurysm occlusion device and a system for occluding aneurysms. [Overview of the project] [Problems that the invention aims to solve]

[0006] Therefore, the technical solution proposed in this application aims to provide an aneurysm occlusion device and a system for occluding an aneurysm in order to solve the problems in the prior art, namely: (1) the problem of compatibility between the configuration of the occlusion device and the size of the aneurysm, (2) the problem of slow thrombus formation because there is no filling material inside the aneurysm, and (3) the possibility of long-term dislodgement because radial support is provided only by the side walls. [Means for solving the problem]

[0007] To solve the above technical problems, the technical solutions of this application are as follows.

[0008] An aneurysm occlusion device is configured to have an elongated configuration that is radially compressible and suitable for transport, and an expandable configuration that elastically deforms to expand radially from the elongated configuration, the expandable configuration including a converging 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 surface toward the lumen and an outer surface opposite to the lumen, the extension segment and the enlarged segment surrounding each other in the circumferential direction to form a lumen, and the free end of the enlarged segment surrounding each other in the circumferential direction to form an annular opening communicating with the lumen.

[0009] If the occlusion device is in an extended configuration, the extension segment extends from a position near the axis toward the axis, and the enlarged segment extends from a position toward the axis toward the axis.

[0010] Selectively, the width value of the enormous segment extending toward the axis is greater than the height value of the enormous segment extending in the axial direction.

[0011] If the closure device is in an extended configuration, it is subjected to radial pressure, and the annular opening becomes smaller.

[0012] The annular opening can be selectively moved toward the proximal or distal end.

[0013] If the occlusion device is not elongated, the outer surface of the enlarged segment forms a first conical cavity surrounding it in the circumferential direction, the tip of the first conical cavity communicating with the annular opening facing the proximal end, or the inner surface of the enlarged segment forms a second conical cavity surrounding it in the circumferential direction, the tip of the second conical cavity communicating with the annular opening facing the distal end.

[0014] Selectively, in the extension segment, the portion connected to the enlarged segment is a bent portion, and in a direction parallel to the axis of the closure device, the free end of the enlarged segment faces the proximal end relative to the bent portion, or the free end of the enlarged segment faces the distal end relative to the bent portion, or the free end of the enlarged segment is flush with the bent portion.

[0015] Selectively, the free end of the enlarged segment faces the proximal end relative to the bend, and when the closure device is pressed by a radial force, the inner surface of the enlarged segment approaches the extension segment, and the outer surfaces of the enlarged segments approach each other in the circumferential direction.

[0016] Selectively, when the closure device is not pressed by a radial force, the first conical cavity has a first taper angle, and when the closure device is pressed by a radial force, the first conical cavity has a second taper angle smaller than the first taper angle.

[0017] Selectively, the free end of the enlarged segment faces the distal end relative to the bend, or the free end of the enlarged segment is flush with the bend, and when the closure device is pressed by a radial force, the outer surface of the enlarged segment extends toward the distal end.

[0018] Selectively, if the closure device is not pressed by a radial force, the second conical cavity has a third taper angle, and if the closure device is pressed by a radial force, the second conical cavity has a fourth taper angle smaller than the third taper angle.

[0019] Selectively, the annular opening closes when the closure device is pressed by a radial force.

[0020] Selectively, the inner and outer surfaces of the enlarged segment are both arc-shaped and both bulge toward the distal end, or the inner surface of the enlarged segment bulges toward the proximal end and the outer surface of the enlarged segment bulges toward the distal end.

[0021] The closure device may be a single-layer structure obtained by pre-forming an elastic tube with non-uniform wall thickness, or a double-layer structure obtained by pre-forming a double-layer mesh tube.

[0022] Selectively, the number of the massive segments is at least two, and the at least two massive segments are spaced perpendicularly along the direction of the axis.

[0023] Selectively, the outer surface of the enlarged segment is partially recessed toward the inner surface of the enlarged segment, or the inner surface of the enlarged segment is partially recessed toward the outer surface of the enlarged segment, and / or, The outer surface of the extension segment is partially recessed toward the inner surface of the extension segment, or the inner surface of the extension segment is partially recessed toward the outer surface of the extension segment, forming at least one recess of the extension segment. [Effects of the Invention]

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

[0025] 1. The aneurysm occlusion device according to the present application is configured to have an elongated configuration that can be compressed in the radial direction for transportation and an expanded configuration that elastically deforms from the elongated configuration to expand in the radial direction. The expanded configuration includes a converging portion located at the connected proximal end, an extension segment, and an enlarged segment connected to the distal end of the extension segment. The enlarged segment extends towards the axis of the occlusion device. The extension segment and the enlarged segment surround circumferentially to form a lumen. The free end of the enlarged segment surrounds circumferentially to form an annular opening communicating with the lumen. Thus, after the occlusion device is placed in the aneurysm, the extension segment is pressed by the aneurysm wall and adheres firmly to the aneurysm wall, and the enlarged segment fills the aneurysm cavity. Compared with the occlusion device without the enlarged segment, the installation of the enlarged segment divides a single chamber into at least two smaller sub-chambers of volumes or a plurality of sub-chambers communicating through narrow passages, the aneurysm neck is blocked by the extension segment, and the blood flow in the aneurysm cavity becomes slower due to the spatial division of the aneurysm cavity by the enlarged segment. Also, since the enlarged segment is present in the aneurysm cavity, it acts like a spring coil to fill and is advantageous for thrombus formation. Furthermore, when the free end of the enlarged segment surrounds circumferentially to form an annular opening and the occlusion device is embedded in the aneurysm and receives a radial pressing force, the annular opening elastically becomes smaller. When the size of the aneurysm unexpectedly becomes larger, the annular opening can elastically become larger. On the one hand, the elastic force / support force can be transmitted through the enlarged segment to the extension segment to provide better support, conform to the patient's life cycle, and avoid the occlusion device falling off from the aneurysm neck. On the other hand, occlusion devices of the same size can be adapted to aneurysms of multiple different sizes. That is, when occlusion devices of the same size are placed in aneurysms of different sizes, the sizes of the annular openings are different.

[0026] 2. In the aneurysm occlusion device according to the present application, the free end of the enlarged segment faces the proximal end with respect to the bent portion. When the occlusion device is pressed by a radial force, the inner surface of the enlarged segment approaches the extension segment, the outer surfaces of the enlarged segments approach each other in the circumferential direction, and the inner surface of the enlarged segment may contact the extension segment in some cases. The extension segment provides good support and can prevent the extension segment from deforming excessively inward along the radial direction (that is, the diameter of the circle formed at the distal end of the extension segment becomes smaller) and falling off from the aneurysm neck of the aneurysm. In addition, since the inner surface of the enlarged segment contacts the extension segment, a plurality of occlusion layers can be formed against the blood at the aneurysm neck, further reducing the amount of blood entering the aneurysm cavity, further weakening the vortex phenomenon in the aneurysm cavity, and promoting the formation of thrombus. Furthermore, since the outer surfaces of the enlarged segments approach each other (at this time, the annular opening moves toward the proximal end), the blood flow path from the annular opening toward the aneurysm top is reduced, the impact force of the blood on the aneurysm top is reduced, and the risk of aneurysm enlargement can be decreased. By the synergistic action of these multiple beneficial factors, the healing of the aneurysm can be promoted.

[0027] 3. In the aneurysm occlusion device according to the present application, the free end of the enlarged segment faces the distal end with respect to the bent portion, or the free end of the enlarged segment is flush with the bent portion. When the occlusion device is pressed by a radial force, the outer surface of the enlarged segment extends toward the distal end (at this time, the annular opening moves toward the distal end). Thus, the adhesion area between the occlusion device and the aneurysm wall can be increased. By increasing the adhesion area, the pressure on the aneurysm wall caused by the blood entering the aneurysm can be reduced to a certain extent, preventing further enlargement of the aneurysm. On the other hand, the size of the chamber formed by the outer surface of the enlarged segment and the aneurysm top can be reduced. The smaller the size, the weaker the vortex phenomenon, which is beneficial for the formation of thrombus in the aneurysm cavity.

[0028] 4. The aneurysm occlusion device according to the present invention gradually shrinks when pressed by a radial force until the annular opening closes, thereby blocking the passage for blood to flow from the lumen through the annular opening to the aneurysm apex, thus avoiding impact on the aneurysm apex by blood and being advantageous for thrombus formation at the aneurysm apex.

[0029] 5. In the aneurysm occlusion device according to the present invention, the free end of the ampulla segment faces proximal to the bend, and when the occlusion device is not pressed by a radial force, the first conical cavity has a first taper angle. When the occlusion device is pressed by a radial force, the inner surface of the ampulla segment approaches toward the extension segment, the outer surfaces of the ampulla segments approach each other in the circumferential direction, and the first conical cavity has a second taper angle smaller than the first taper angle, or the free end of the ampulla segment faces distal to the bend, or the free end of the ampulla segment is flush with the bend. When the occlusion device is not pressed by a radial force, the second conical cavity has a third taper angle. When the occlusion device is pressed by a radial force, the outer surface of the ampulla segment extends toward the distal end, and the second conical cavity has a fourth taper angle smaller than the third taper angle. The taper angle of the first or second conical cavity can be changed in response to the deformation of the enlarged segment when the occlusion device is pressed by a radial force (the angle of the inner or outer surface of the enlarged segment changes when the occlusion device is subjected to a radial force), thereby improving the deformability of the enlarged segment and improving the conformability of the occlusion device to the aneurysm lumen.

[0030] This invention relates to a system for occluding an aneurysm, The aforementioned aneurysm occlusion device, A system for occluding an aneurysm is further disclosed, including a transport member or a release member corresponding to the aneurysm occlusion device.

[0031] Selectively, the aneurysm is a platystorum aneurysm at an intracranial bifurcation.

[0032] The technical solution of this application has the following advantages.

[0033] The system for occluding an aneurysm according to the present invention has all the advantages of the aneurysm occlusion devices described above. [Brief explanation of the drawing]

[0034] [Figure 1] This is a schematic cross-sectional view of the occlusion device disclosed in Embodiment 1 of the present application. [Figure 2] This is a schematic diagram showing the changes in the configuration of the occlusion device disclosed in Embodiment 1 of the present application before and after it is pressed radially, with solid lines representing the configuration before the force is applied and dashed lines representing the configuration after the force is applied. [Figure 3] This is a schematic diagram showing a configuration in which the occlusion device disclosed in Embodiment 1 of the present application is pressed radially within an aneurysm. [Figure 4] This is a schematic cross-sectional view of the occlusion device disclosed in Embodiment 2 of the present application. [Figure 5] Figure 4 is a schematic diagram showing how the occlusion device is pressed radially within the aneurysm. [Figure 6] This is a straight view of the occlusion device disclosed in Embodiment 3 of the present application. [Figure 7] This is a schematic perspective view of the occlusion device disclosed in Embodiment 3 of the present application. [Figure 8] This is a schematic cross-sectional view of the occlusion device disclosed in Embodiment 3 of the present application. [Figure 9] This is a schematic diagram showing the changes in the configuration of the occlusion device disclosed in Embodiment 3 of the present application before and after it is pressed radially, with solid lines representing the configuration before the force is applied and dashed lines representing the configuration after the force is applied. [Figure 10] This is a schematic diagram showing the occlusion device disclosed in Embodiment 3 of the present application being pushed into the delivery catheter and cooperating with the delivery catheter and the push wire. [Figure 11] This is a schematic diagram showing the form of a portion of the occlusion device disclosed in Embodiment 3 of the present application after it has been pushed out of the delivery catheter. [Figure 12]This is a schematic diagram showing a configuration in which the small-sized occlusion device disclosed in Embodiment 3 of the present application is positioned within a large aneurysm. [Figure 13] This is a schematic diagram showing a configuration in which a large occlusion device, as disclosed in Embodiment 3 of the present application, is positioned within a small aneurysm. [Figure 14] This is a schematic cross-sectional view of the occlusion device disclosed in Embodiment 4 of the present application. [Figure 15] This is a schematic cross-sectional view of the occlusion device disclosed in Embodiment 5 of the present application. [Figure 16] This is a schematic cross-sectional view of the occlusion device disclosed in Embodiment 6 of the present application. [Modes for carrying out the invention]

[0035] To more clearly illustrate specific embodiments of the present invention or technical solutions in the prior art, the drawings to be used for describing specific embodiments or the prior art will be briefly described below. Clearly, the drawings described below are some embodiments of the present application, and those skilled in the art can obtain further drawings based on these without any creative effort.

[0036] The technical solutions of the present application will be described clearly and completely below with reference to the drawings, and it will be clear that the embodiments described are some, but not all, embodiments of the present application. Any other embodiments that a person skilled in the art can obtain without creative work based on the embodiments of the present application are all within the scope of protection of the present application.

[0037] Furthermore, in the description of this application, the directions or positional relationships indicated by terms such as "center," "top," "vertical," "inside," and "outside" are directions or positional relationships based on the illustrations and are merely for the purpose of facilitating or simplifying the description of this application. They do not indicate or suggest that the device or element in question necessarily has a specific direction or is configured and operated in a specific direction, and therefore should not be understood as limiting this application. In addition, the terms "first," "second," and "third" are used solely for explanatory purposes and should not be understood as indicating or suggesting relative importance, and the term "axial direction" means the direction along the centerline of the aneurysm occlusion device.

[0038] In this description, unless otherwise specified or limited, the terms "attachment," "connection," and "connection" should be understood in a broad sense. For example, they may be fixed connections, detachable connections, or integral connections; they may be mechanical connections or electrical connections; they may be direct connections or indirect connections via an intermediate medium; or they may be internal communication between two elements. A person skilled in the art will be able to understand the specific meaning of these terms in this application depending on the specific circumstances.

[0039] Furthermore, the technical features of the various embodiments of the present application described below can be combined with each other, insofar as they do not contradict each other.

[0040] As shown in Figures 1 to 16, the present invention provides a system for occluding an aneurysm, comprising an aneurysm occlusion device and a transport member 6 or release member corresponding to the aneurysm occlusion device. The aneurysm is a platydroma aneurysm at an intracranial bifurcation.

[0041] The occlusion device has three forms, including a form configured to have an elongated structure that is compressible in the radial direction and suitable for transport (also called the transport form), an expandable form that elastically deforms to expand radially from the elongated structure (also called the freely deployable form, in which the occlusion device is not pressed by external force), and a form that is pressed against the aneurysm wall. In this embodiment, the occlusion device is a double-layer structure obtained by pre-forming a double-layer woven mesh (for example, by heat setting; it may undergo two heat sets, three or more heat sets). The double-layer woven mesh is formed by folding a single-layer woven mesh and then nesting the inner and outer layers. Specifically, one end of the woven wire of the woven mesh extends to the distal end, is folded back at the distal end, and then extends to the proximal end, and both ends of the woven wire are all gathered at the converging segment at the proximal end (not shown). The number of strands in the double-layer woven mesh can be selected from 48, 64, 72, 96, 108, or 116, and the diameter of the strands can be selected from 0.0006 inches to 0.014 inches. The strands can be made of metal or polymer material. In other embodiments, the closure device is a single-layer structure, specifically obtained by pre-forming an elastic tube with non-uniform wall thickness.

[0042] The occlusion device, whether single-layered or double-layered, is an elastically deformable body having a radially compressible elongated configuration and an expandable configuration that elastically deforms to expand radially from the elongated configuration, wherein the expandable configuration deforms when subjected to force and returns to its original shape when the external force is removed.

[0043] In the extended configuration, the occlusion device includes, in order, a converging segment (not shown, the converging segment is housed within the connection part 1) located at the proximal end, an extension segment 3, an enlarged segment 4 formed by extending from the distal end of the extension segment 3, and the connection part 1. The extension segment 3 and the enlarged segment 4 surround each other in the circumferential direction to form a lumen A. In this embodiment, the extension segment 3 extends from a position near the axis toward the axis, and the enlarged segment 4 extends from a position toward the axis toward the axis. The extension segment 3 and the enlarged segment 4 surround each other, forming a cross-sectional shape similar to "<>".

[0044] The connector 1 secures and tightens the convergence segment, that is, it firmly binds and converges the ends of the inner and outer knitted wires, preventing the double-layer woven mesh from unraveling. The connector 1 can be made of a material that is X-ray developable to facilitate positioning. The connector 1 and the push wire 61 are detachably connected to facilitate the transport and implantation of the occlusion device into the aneurysm. In this embodiment, the inner and outer layers of the extension segment 3 are described as being spaced apart from each other or at equal intervals along its length, whereas in other embodiments, the inner and outer layers of the extension segment 3 may be in contact with each other or at unequal intervals along its entire length or in part, specifically, for example, the inner layer may be pressed radially outward against the outer layer.

[0045] The extension segment 3 is formed by extending upward from the converging segment and has an overall bowl shape. In Figures 1-4, the extension segment 3 is depicted as having an arc shape with its bottom (i.e., the area near the connection part 1) projecting towards the proximal end (i.e., the bottom is concave downward when the occlusion device is positioned vertically). However, in other embodiments, the bottom may be an arc shape that is convex toward the distal end (i.e., the bottom is convex upward when the occlusion device is positioned vertically), or the bottom may be flat. For the sake of explanation, the connection part between the distal end of the extension segment 3 and the enlarged segment 4 will be defined as the bent part 32. The extension segment 3 also has an outer surface B (shown in Figure 1) and an inner surface C (shown in Figure 1).

[0046] The large segment 4 extends from a position away from the axis toward the axis of the blocking device (shown by the dashed line in Figures 1, 4, and 8).

[0047] Figures 1 to 3 show Embodiment 1 of the occlusion device disclosed herein, in which the free end 40 of the enlarged segment 4 is flush with the bent portion 32, the enlarged segment 4 and the extension segment 3 surround each other in the circumferential direction to form a lumen A, the free end 40 of the enlarged segment 4 surrounds each other in the circumferential direction to form an annular opening 42, and the annular opening 42 communicates with the lumen A. In Figure 1, the inner surface X of the enlarged segment 4 is slightly raised toward the distal end, and the outer surface Y of the enlarged segment is significantly raised toward the distal end. In Figure 2, the inner surface X of the enlarged segment 4 is raised toward the proximal end, the outer surface Y of the enlarged segment is raised toward the distal end, the inner surface X of the enlarged segment surrounds each other in the circumferential direction to form a second conical cavity 44, and the second conical cavity 44 has a third taper angle θ3. Continuing to refer to Figure 2, the morphological views of the occlusion device before and after being pressed are shown in contrast. As can be seen from Figure 2, after being pressed, the annular opening 42 becomes smaller and moves to the distal end, and the taper angle of the second conical cavity 44 decreases to become the fourth taper angle θ4. In this embodiment, the second conical cavity 44 is formed by being surrounded by tangents to corresponding points in the circumferential direction of the inner surface X of the enlarged segment, and a fixed point is required as a reference in order to compare the change in the taper angle.

[0048] When the occlusion device is positioned within the aneurysm, as shown in Figure 3, the extension segment 3 occludes the aneurysm neck 52. Due to the size difference (in the expanded configuration, the width of the occlusion device must be greater than the width of the aneurysm), the occlusion device receives radial inward pressure from the aneurysm wall 50 while simultaneously providing support for radial outward expansion. Within the aneurysm, the occlusion device is compressed by the aneurysm wall, causing the annular opening 42 to become smaller or even closed compared to the freely deployable configuration. In this way, the passage for blood to flow through the annular opening 42 to the aneurysm apex 53 can be reduced or blocked, allowing more blood, or even all of it, to remain in the lumen A, reducing or blocking the impact of blood on the aneurysm apex 53, and preventing further expansion of the aneurysm. Furthermore, the deformation of the annular opening 42 allows the occlusion device to adapt to aneurysm cavities 51 of different sizes. The radial outward force generated by the reduction in the annular opening 42 provides radial support to the occlusion device, preventing the extension segment 3 from detaching from the aneurysm neck 52 of the arterial aneurysm due to insufficient support.

[0049] Figures 4 and 5 show an embodiment 2 of the occlusion device disclosed herein, referring to Figure 4, where the free end 40 of the enlarged segment 4 is oriented distal to the bent portion 32. The free end 40 of the enlarged segment 4 forms an annular opening 42 surrounded in the circumferential direction. The inner surface X of the enlarged segment 4 is raised toward the proximal end, and the outer surface Y of the enlarged segment is raised toward the distal end. The inner surface X of the enlarged segment forms a second conical cavity 44 surrounded in the circumferential direction, and the second conical cavity 44 has a third taper angle θ3. In this embodiment, the second conical cavity 44 is formed by being surrounded by tangents to corresponding points in the circumferential direction of the inner surface X of the enlarged segment, and a fixed point is required as a reference in order to compare the change in the taper angle.

[0050] Referring to Figure 5, when the occlusion device is positioned within the aneurysm, the extension segment 3 occludes the aneurysm neck 52, the occlusion device contracts radially under radial pressure from the aneurysm wall 50, the outer surface Y of the enlarged segment extends toward the distal end, increasing the contact area between the occlusion device and the aneurysm wall 50, which reduces to some extent the pressure on the aneurysm wall 50 from the blood that has entered the aneurysm and can prevent further expansion of the aneurysm. In addition, the inner surfaces X of the enlarged segments approach each other in the circumferential direction, the taper angle of the second conical cavity 44 decreases accordingly to become the fourth taper angle θ4, the annular opening 42 also decreases accordingly, and in some cases the inner surfaces X of the enlarged segments come into contact with each other, closing the annular opening 42, further reducing or blocking the passage for blood to flow through the annular opening 42 to the aneurysm apex 53, thereby retaining more blood, or even all of the blood, within the lumen A, reducing or blocking the impact of the blood on the aneurysm wall 50 and the aneurysm apex 53, and preventing further expansion of the aneurysm. Furthermore, due to the deformation of the annular opening 42 and the change in the taper angle of the second conical cavity 44, the occlusion device can be applied to aneurysm cavities 51 of different sizes. The radial outward force generated by the reduction of the annular opening 42 and the decrease in the taper angle of the second conical cavity 44 provides radial support to the occlusion device, preventing the extension segment 3 from detaching from the aneurysm neck 52 of the arterial aneurysm due to insufficient support. In extreme cases, for example, when the inner surfaces X of the enlarged segments of the occlusion device abut against each other and become one, the occlusion device can be provided with even greater radial support. Moreover, the inner surfaces X of the enlarged segments are raised towards the proximal end, providing a component force that extends toward the distal end, which in turn improves the overall deformability and conformability to the aneurysm of the occlusion device.

[0051] Figures 6 to 9 show three embodiments of the occlusion device disclosed herein, in which the free end 40 of the enlarged segment 4 faces proximal to the bent portion 32. The free end 40 of the enlarged segment 4 forms an annular opening 42 surrounded in the circumferential direction. The annular opening 42 communicates with the lumen A. The inner surface X of the enlarged segment 4 is raised toward the proximal end, and the outer surface Y of the enlarged segment is raised toward the distal end. Referring to Figure 9, the outer surface Y of the enlarged segment forms a first conical cavity 43 surrounded in the circumferential direction, and the first taper angle of the first conical cavity 43 is θ1. In this embodiment, the second conical cavity 44 is formed surrounded by tangents to corresponding points in the circumferential direction of the outer surface Y of the enlarged segment, and a fixed point is required as a reference in order to compare the change in taper angle.

[0052] Referring to Figure 9, which exaggerates the changes in configuration before and after the occlusion device is subjected to radial pressure, in which the annular opening 42 becomes smaller and moves to the proximal end. For clarity, Figure 9 also shows two configurations of the occlusion device: the freely deployed form (shown by a solid line) and the form in which it is pressed by the aneurysm wall (shown by a dashed line).

[0053] When the occlusion device is positioned within the aneurysm, the extension segment 3 occludes the aneurysm neck 52. When the occlusion device is subjected to radial compression, the free end 40 of the ampulla segment extends toward the proximal end, so the inner surface X of the ampulla segment gradually approaches the extension segment 3, the annular opening 42 moves toward the proximal end, and at the same time, the outer surfaces Y of the ampulla segments approach each other. If the radial compression is sufficiently large, the inner surface X of the ampulla segment abuts against the extension segment 3, and the outer surfaces Y of the ampulla segments abut each other, the taper angle of the first conical cavity 43 decreases to the second taper angle θ2, further reducing or blocking the passage for blood to flow through the annular opening 42 to the distal end, retaining more blood, or even all of the blood, in the lumen A, reducing or blocking the impact of blood on the aneurysm wall 50, and preventing further expansion of the aneurysm. Furthermore, due to the change in the taper angle of the first conical cavity 43 and the deformation of the annular opening 42, the occlusion device can be adapted to aneurysm cavities 51 of different sizes. When the annular opening 42 becomes smaller, its elastic restoring force provides radial support to the occlusion device, preventing the extension segment 3 from detaching from the aneurysm neck 52 due to insufficient support. In particular, when the occlusion device receives a large radial compressive force and the outer surfaces Y of the enlarged segments abut each other and become one, the occlusion device can be provided with even greater radial support. Also, since the inner surface X of the enlarged segment is raised toward the proximal end, the enlarged segment 4 quickly abuts against the extension segment 3, providing radial support to the extension segment 3 in a timely manner, and preventing the extension segment 3 from excessively deforming inward along the radial direction and detaching from the aneurysm neck 52. Furthermore, the enlarged segment 4 approaches and, in some cases, abuts against the extended segment 3, thereby forming multiple occluding layers against the blood at the aneurysm neck 52, further reducing the blood entering the aneurysm lumen 51 and further promoting the healing of the aneurysm. In this embodiment, when the aneurysm is large (as shown in Figure 12), the reduction of the annular opening 42 is not significant, while when the aneurysm is small (as shown in Figure 13), the reduction of the annular opening 42 is significant, and in some cases, the annular opening 42 may even close.

[0054] In the three embodiments described above, the distal end of the deformed occlusion device is not in contact with the aneurysm crest 53 at the center of the apex.

[0055] The following describes the process of using the aneurysm occlusion device according to this embodiment, using the occlusion device of Embodiment 3 as an example.

[0056] First, the distal end of the delivery catheter 62 is positioned within the aneurysm. Then, the push wire 61 is pushed along the delivery catheter 62 to release the occlusion device from the delivery catheter 62 and position it within the aneurysm. A schematic diagram of the partially deployed occlusion device is shown in Figure 11. Once the occlusion device is fully inside the aneurysm, it cannot expand to its fully deployed form due to the limitations of the aneurysm wall 50. The extension segment 3 of the occlusion device occludes the aneurysm neck 52. The occlusion device remains within the aneurysm lumen 51 and is compressed by the aneurysm wall. Figures 12 and 13 show the deformation diagrams of the occlusion device at two different levels of compression, respectively.

[0057] When the occlusion device reaches the predetermined position, the release member (electrically or mechanically) disconnects the connection between the connection part 1 and the push wire 61, retracts the push wire 61, and then retracts the delivery catheter 62, completing the placement of the occlusion device.

[0058] In this embodiment, the aneurysm occlusion device, compared to an occlusion device without an enlarged segment, has the following advantages: the single chamber is divided into at least two smaller sub-catheters or multiple sub-catheters connected by narrow passages; the aneurysm neck 52 is occluded by the extension segment 3; and the enlarged segment 4 spatially divides the chamber, resulting in slower blood flow within the aneurysm lumen 51. Furthermore, because the enlarged segment 4 is located within the aneurysm lumen 51, it acts like a spring coil, providing a filling effect that is advantageous for thrombus formation. Additionally, the free end 40 of the enlarged segment 4 surrounds the annular opening 42 in the circumferential direction. When the occlusion device is embedded in the aneurysm and subjected to radial pressure, the annular opening 42 elastically shrinks, and if the aneurysm size becomes unexpectedly large, the annular opening 42 can elastically enlarge. On the one hand, the elastic / supporting force can be transmitted to the extended segment 3 via the enlarged segment 4 to provide better support, which can be adapted to the patient's life cycle and prevent the occlusion device from falling out of the aneurysm neck 52. On the other hand, an occlusion device of the same size can be adapted to multiple different sized aneurysms, meaning that when an occlusion device of the same size is placed in an aneurysm of different sizes, the size of the annular opening 42 will be different.

[0059] The aneurysm occlusion device according to this embodiment can simultaneously satisfy the needs for the conformability of the occlusion device, filling of the aneurysm with a high-density mesh, and improvement of the metal coverage rate at the aneurysm neck 52. This further obstructs changes in blood flow within the aneurysm, accelerates the formation of spontaneous thrombi in the aneurysm lumen 51, and improves the timeliness of aneurysm treatment. Furthermore, the aneurysm occlusion device according to this embodiment is constructed by folding a single-layer woven mesh and then forming a double-layer woven mesh structure by nesting the inner and outer layers, followed by two heat-setting processes. Compared to a single-layer configuration, it can achieve higher aneurysm support performance, improve the stability of the occlusion device within the aneurysm lumen 51, and increase the metal coverage rate at the aneurysm neck 52, further obstructing blood flow into the aneurysm lumen 51. Moreover, the installation of the hollow, enlarged segment 4 not only enables filling of the aneurysm lumen 51 with a high-density metal mesh, but also spatially divides the aneurysm lumen 51, increasing blood flow resistance within the aneurysm, accelerating thrombus formation within the aneurysm lumen 51, and promoting rapid healing of the aneurysm.

[0060] Furthermore, referring to Figures 14 to 16, which illustrate other embodiments of the closure device, the closure device in Figure 14 has two enlarged segments 4, and of course, it may have more. The enlarged segment 4 in Figure 15 is provided with two enlarged segment recesses 45, and of course, it may have more. The enlarged segment recesses 45 are formed by partially recessing from the outer surface Y of the enlarged segment toward the inner surface X of the enlarged segment. In Figure 16, there are two enlarged segments 4, and the upper enlarged segment 4 is provided with two enlarged segment recesses 45. Of course, in other embodiments, in order to improve the deformability of the extension segment 3, at least one extension segment recess may be formed by recessing from the outer surface B (shown in Figure 1) of the extension segment toward the inner surface C (shown in Figure 1) of the extension segment 3.

[0061] Clearly, the above embodiments are merely illustrative examples for clarity and do not limit the embodiments. Those skilled in the art can make various other forms of changes or modifications based on the above description. It is not necessary, nor is it possible, to cover all embodiments here. Any obvious changes or modifications derived from these also fall within the scope of the present invention. [Explanation of symbols]

[0062] A, lumen B, outer surface of the extended segment C, inner surface of extended segment X, inner surface of the enormous segment Y, outer surface of a large segment 1. Connection part 3. Extended segment 32. Bending section 4. Enormous segments 40, free end 42. Annular opening 43. First conical cavity 44. Second conical cavity 45. Enormous segment recess 50, aneurysm wall 51, aneurysm cavity 52, aneurysm neck 53, aneurysm top 6. Transport components 61. Push wire 62. Delivery catheter.

Claims

1. An aneurysm occlusion device, wherein the aneurysm occlusion device is configured to have an elongated configuration that is compressible in the radial direction and suitable for transport, and an expandable configuration that elastically deforms to expand radially from the elongated configuration, the expandable configuration includes a converging portion located at the proximal end, an extension segment (3), and an enlarged segment (4) connected to the distal end of the extension segment (3), the extension segment (3) and the enlarged segment (4) surround each other in the circumferential direction to form a lumen (A), the enlarged segment (4) extends toward the axis of the occlusion device, the enlarged segment (4) has an inner surface (X) facing the lumen (A) and an outer surface (Y) opposite to the lumen (A), and the free end (40) of the enlarged segment (4) surrounds each other in the circumferential direction to form an annular opening (42) communicating with the lumen (A), characterized in that the aneurysm occlusion device is configured to have an elongated configuration that is compressible in the radial direction and suitable for transport, and an expandable configuration that elastically deforms to expand radially from the elongated configuration, the expandable configuration includes a converging portion located at the proximal end, an extension segment (3), and an enlarged segment (4) connected to the distal end of the extension segment (3), the extension segment (3) and the enlarged segment (4) surround each other in the circumferential direction to form an annular opening (42) communicating with the lumen (A).

2. The aneurysm occlusion device according to claim 1, characterized in that, when the occlusion device has an extended configuration, the extension segment (3) extends from a position near the axis toward the axis, and the enlarged segment (4) extends from a position toward the axis toward the axis.

3. The aneurysm occlusion device according to claim 2, characterized in that the width value of the enlarged segment (4) extending toward the axis is greater than the height value of the enlarged segment (4) extending in the axial direction.

4. The aneurysm occlusion device according to claim 1, characterized in that, when the occlusion device has an expanded configuration, the occlusion device receives a radial pressing 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 occlusion device is not elongated, the outer surface (Y) of the enlarged segment forms a first conical cavity (43) surrounding it in the circumferential direction, and the tip of the first conical cavity (43) is facing the proximal end and communicating with the annular opening (42), or the inner surface (X) of the enlarged segment forms a second conical cavity (44) surrounding it in the circumferential direction, and the tip of the second conical cavity (44) is facing the distal end and communicating with the annular opening (42).

7. The aneurysm occlusion device according to claim 6, characterized in that the extension segment (3) has a bent portion (32) at the point where it is connected to the enlarged segment (4), and in a direction parallel to the axis of the occlusion device, the free end (40) of the enlarged segment (4) faces the proximal end with respect to the bent portion (32), or the free end (40) of the enlarged segment (4) faces the distal end with respect to the bent portion (32), or the free end (40) of the enlarged segment (4) is flush with the bent portion (32).

8. The aneurysm occlusion device according to claim 7, characterized in that the free end (40) of the enlarged segment (4) faces the proximal end with respect to the bent portion (32), and when the occlusion device is pressed by a radial force, the inner surface (X) of the enlarged segment approaches the extension segment (3), and the outer surfaces (Y) of the enlarged segments approach each other in the circumferential direction.

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

10. The aneurysm occlusion device according to claim 7, characterized in that the free end (40) of the enlarged segment (4) faces the distal end with respect to the bent portion (32), or the free end (40) of the enlarged segment (4) is flush with the bent portion (32), and when the occlusion device is pressed by a radial force, the outer surface (Y) of the enlarged segment extends toward the distal end.

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

12. The aneurysm occlusion device according to any one of claims 8 to 11, characterized in that the annular opening (42) closes when the occlusion device is pressed by a radial force.

13. The aneurysm occlusion device according to claim 1, characterized in that both the inner surface (X) and the outer surface (Y) of the enlarged segment are arc-shaped surfaces and both are raised toward the distal end, or the inner surface (X) of the enlarged segment is raised toward the proximal end and the outer surface (Y) of the enlarged segment is raised toward the distal end.

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

15. The aneurysm occlusion device according to claim 1, characterized in that the number of the enlarged segments (4) is at least two, and at least two of the enlarged segments (4) are arranged at intervals in a vertical direction along the direction of the axis.

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

17. A system for occluding an aneurysm, An aneurysm occlusion device according to any one of claims 1 to 16, A system for occluding an aneurysm, comprising a transport 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 platystoral artery aneurysm at an intracranial bifurcation.

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