Aneurysm plugging device and system for plugging aneurysm

Abstract

The invention discloses an aneurysm plugging device and a system for plugging aneurys.The aneurysm plugging device is constructed to be in a long and thin structure which is compressed in the radial direction and suitable for conveying and in an expanded structure which is elastically converted into radial expansion from the long and thin structure. The gathering part and the extending section are located at the near end, the expanding section is connected with the far end of the extending section, the expanding section extends towards the axis of the plugging device, an inner cavity is defined by the extending section and the expanding section in the circumferential direction, and an annular opening communicated with the inner cavity is defined by the free end of the expanding section in the circumferential direction. After the plugging device is placed in the aneurysm, the extension section plugs the aneurysm neck opening and is tightly attached to the aneurysm wall, the expansion section fills the aneurysm cavity, blood flow from a carrier flow pulse to the aneurysm top is reduced, the blood flow in the aneurysm cavity flows more slowly, thrombus formation and aneurysm healing are facilitated, and the plugging device can be prevented from falling off from the aneurysm neck opening.

Description

Technical Field

[0001] The present invention relates to the technical field of occlusion devices, and particularly to an aneurysm occlusion device and a system for occluding aneurysms. Background Art

[0002] Intracranial aneurysms are a common intracranial disease. The prevalence of aneurysms is approximately between 7% and 9%. The presence of intracranial aneurysms in the human body poses a great risk. Once an aneurysm ruptures, it will trigger hemorrhagic stroke, causing the patient to fall into a coma or even be in life-threatening danger, posing a huge threat to people's health.

[0003] Currently, the main methods for treating aneurysms are: surgical clipping, coils combined with auxiliary stents, intratumoral flow-disturbing braids, etc. Among them, surgical clipping has extremely high surgical risks and high surgical costs, bringing relatively great economic and mental pressures to patients; coils combined with auxiliary stents are a relatively good interventional treatment plan for aneurysms, but coils combined with auxiliary stents are not applicable to the treatment of wide-neck aneurysms at bifurcations. For wide-neck aneurysms at bifurcations, a company first proposed a lantern-shaped intratumoral flow-disturbing braid, which has certain clinical effects, but also has many limitations. One of them is that its lantern-shaped configuration hinders its adaptability to aneurysms, and many specifications need to be designed to adapt to different aneurysms, with poor conformability. Subsequently, another company designed another typical occlusion device, whose design configuration is similar to an open bowl shape, mainly used to occlude the aneurysm neck. Because it is an open design, only the size of the aneurysm neck needs to be considered, and the shape of the aneurysm body does not need to be considered. One specification can adapt to a certain range of aneurysms, and the conformability has been improved, and the one-year aneurysm occlusion rate is similar to that of the former. However, for the bowl-shaped occlusion device, its metal mesh is only distributed at the aneurysm neck, and there is no filling in the aneurysm body. Due to the inevitable blood flow passing through the occlusion device into the aneurysm and / or the existence of vortex flow in the aneurysm, compared with the occlusion device with filling, the cycle of blood clot formation in the aneurysm may be longer; in addition, the bowl-shaped occlusion device has no support, and only relies on the side wall of the bowl to fit the aneurysm wall, and there may be a risk of detachment in the long term.

[0004] Therefore, it is necessary to design an aneurysm occlusion device and a system for occluding aneurysms to solve the above problems. Summary of the Invention

[0005] Therefore, the technical solution proposed by the present invention aims to solve the problems in the prior art: (1) the adaptability problem between the configuration of the occlusion device and the size of the aneurysm body, (2) the lack of filling in the aneurysm body, resulting in slow thrombus formation, and (3) relying solely on the side wall to provide radial support force, there may be a risk of detachment in the long term, thereby providing an aneurysm occlusion device and a system for occluding aneurysms.

[0006] To solve the above technical problems, the technical solution of the present invention is as follows:

[0007] An aneurysm occlusion device, which is configured to have an elongated configuration suitable for delivery with radial compression, and is elastically transformed from the elongated configuration into a radially expanded expanded configuration. The expanded configuration includes a converging portion located at the proximal end, an extension section, and an enlarged section connected to the distal end of the extension section, which are connected in sequence. The enlarged section extends towards the axis of the occlusion device. The enlarged section has an inner side surface of the enlarged section facing the inner cavity and an outer side surface of the enlarged section facing away from the inner cavity. The extension section and the enlarged section circumferentially enclose to form an inner cavity, and a circumferentially enclosed annular opening communicating with the inner cavity is formed at the free end of the enlarged section.

[0008] Further, when the occlusion device is in the expanded configuration, the extension section extends from a position near the axis towards a direction away from the axis, and the enlarged section extends from a position away from the axis towards the axis.

[0009] Further, the width value of the enlarged section extending towards the axis is greater than the height value of the enlarged section extending along the axis.

[0010] Further, when the occlusion device is in the expanded configuration, the occlusion device is subjected to a radial squeezing force, and the annular opening becomes smaller.

[0011] Further, the annular opening moves towards the proximal end or the distal end.

[0012] Further, when the occlusion device is in a non-elongated configuration, the outer side surface of the enlarged section circumferentially encloses to form a first conical cavity, the tip of the first conical cavity faces the proximal end and communicates with the annular opening, or the inner side surface of the enlarged section circumferentially encloses to form a second conical cavity, the tip of the second conical cavity faces the distal end and communicates with the annular opening.

[0013] Further, the connection part of the extension section and the enlarged section is a turning part. In the direction parallel to the axis of the occlusion device, the free end of the enlarged section is towards the proximal end relative to the turning part, or the free end of the enlarged section is towards the distal end relative to the turning part, or the free end of the enlarged section is flush with the turning part.

[0014] Further, when the free end of the enlarged section is towards the proximal end relative to the turning part, when the occlusion device is subjected to radial force extrusion, the inner side surface of the enlarged section approaches the extension section, and the outer side surfaces of the enlarged section approach each other circumferentially.

[0015] Further, when the plugging device is not subjected to radial force extrusion, the first conical cavity has a first taper angle, and when the plugging device is subjected to radial force extrusion, the first conical cavity has a second taper angle, and the second taper angle is smaller than the first taper angle.

[0016] Further, the free end of the enlarged section faces distally relative to the turning portion, or the free end of the enlarged section is flush with the turning portion. When the plugging device is subjected to radial force extrusion, the outer side surface of the enlarged section extends distally.

[0017] Further, when the plugging device is not subjected to radial force extrusion, the second conical cavity has a third taper angle, and when the plugging device is subjected to radial force extrusion, the second conical cavity has a fourth taper angle, and the fourth taper angle is smaller than the third taper angle.

[0018] Further, when the plugging device is subjected to radial force extrusion, the annular opening closes.

[0019] Further, both the inner side surface and the outer side surface of the enlarged section are arc-shaped surfaces, both arching distally, or the inner side surface of the enlarged section arches proximally and the outer side surface of the enlarged section arches distally.

[0020] Further, the plugging 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 plugging device is a double-layer structure, and the double-layer structure is pre-shaped from a double-layer network tube.

[0021] Further, the number of the enlarged sections is at least two, and at least two of the enlarged sections are vertically spaced along the axial direction.

[0022] Further, at least one enlarged section recess is formed by the outer side surface of the enlarged section partially recessing towards the inner side surface of the enlarged section or the inner side surface of the enlarged section partially recessing towards the outer side surface of the enlarged section, and / or,

[0023] at least one extension section recess is formed by the outer side surface of the extension section partially recessing towards the inner side surface of the extension section or the inner side surface of the extension section partially recessing towards the outer side surface of the extension section.

[0024] The technical solution of the present invention has the following advantages:

[0025] 1. The aneurysm occlusion device provided by the present invention is configured to have an elongated configuration that is radially compressible for delivery and an expanded configuration that elastically transforms from the elongated configuration to a radially expanded state. The expanded configuration includes a converging portion located at the proximal end, an extension section, and an enlarged section connected to the distal end of the extension section. The enlarged section extends towards the axis of the occlusion device. The extension section and the enlarged section circumferentially enclose to form an inner cavity, and the free end of the enlarged section circumferentially encloses to form an annular opening communicating with the inner cavity. In this way, after the occlusion device is placed in the aneurysm, the extension section is squeezed by the aneurysm wall and closely adheres to the aneurysm wall, and the enlarged section fills the aneurysm cavity. Compared with the occlusion device without the enlarged section, the setting of the enlarged section divides a single chamber into at least two sub-chambers with smaller volumes or multiple sub-chambers connected by narrow channels, the aneurysm neck is blocked by the extension section, and the effect of the space division of the enlarged section chamber makes the blood flow in the aneurysm cavity slower; in addition, due to the presence of the enlarged section in the aneurysm cavity, it plays a filling role similar to that of a coil, which is conducive to the formation of thrombus; furthermore, the annular opening formed by the circumferential enclosure of the free end of the enlarged section can elastically become smaller when the occlusion device is implanted into the aneurysm and subjected to a radial squeezing force, and can elastically become larger when the aneurysm size increases undesirably. On the one hand, the elastic force / support force is transmitted to the extension section through the enlarged section to provide better support, adapt to the patient's life cycle, and prevent the occlusion device from falling off from the aneurysm neck. On the other hand, the same-sized occlusion device can be adapted to multiple aneurysms of different sizes, that is, when the same-sized occlusion device is placed in aneurysms of different sizes, it has different sizes of annular opening dimensions.

[0026] 2. In the aneurysm occlusion device provided by the present invention, the free end of the enlarged section faces the proximal end relative to the turning portion. When the occlusion device is subjected to a radial force squeezing, the inner side surface of the enlarged section approaches the extension section, the outer side surfaces of the enlarged section approach each other circumferentially, and the inner side surface of the enlarged section even abuts against the extension section, which can provide better support for the extension section, prevent the extension section from deforming excessively inward in the radial direction (i.e., the diameter of the circle formed by the distal end of the extension section becomes smaller), and prevent it from falling off from the aneurysm neck. In addition, the inner side surface of the enlarged section abuts against the extension section, which can form more layers of blockage of the blood at the aneurysm neck, further reduce the blood entering the aneurysm cavity, further weaken the vortex phenomenon in the aneurysm cavity, and promote the formation of thrombus. Furthermore, the outer side surfaces of the enlarged section approach each other (at this time, the annular opening moves towards the proximal end), which can reduce the blood flow path from the annular opening to the aneurysm top direction, reduce the impact force of the blood on the aneurysm top, and reduce the risk of the aneurysm being enlarged. The mutual superposition of multiple favorable factors will promote the healing of the aneurysm.

[0027] 3. For the aneurysm occlusion device provided by the present invention, the free end of the enlarged section faces distally relative to the turning part, or the free end of the enlarged section is flush with the turning part. When the occlusion device is squeezed by a radial force, the outer side surface of the enlarged section extends distally (at this time, the annular opening moves distally). In this way, the contact area between the occlusion device and the aneurysm wall can be increased. The increase in the contact area can, to a certain extent, relieve the pressure of the blood flow entering the aneurysm on the aneurysm wall and prevent the further growth of the aneurysm. On the other hand, it will also reduce the size of the chamber formed by the outer side surface of the enlarged section and the aneurysm apex. The smaller the size, the weaker the eddy current phenomenon, which is conducive to the formation of thrombus in the aneurysm cavity.

[0028] 4. For the aneurysm occlusion device provided by the present invention, when the occlusion device is squeezed by a radial force, the annular opening gradually decreases until it closes, which can block the channel for blood to flow from the inner cavity to the aneurysm apex through the annular opening, avoid the impact of blood on the aneurysm apex, and is also conducive to the formation of thrombus at the aneurysm apex.

[0029] 5. For the aneurysm occlusion device provided by the present invention, the free end of the enlarged section faces proximally relative to the turning part. When the occlusion device is not squeezed by a radial force, the first conical cavity has a first taper angle. When the occlusion device is squeezed by a radial force, the inner side surface of the enlarged section approaches the extension section, and the outer side surfaces of the enlarged section approach each other circumferentially. The first conical cavity has a second taper angle, and the second taper angle is smaller than the first taper angle. Or, the free end of the enlarged section faces distally relative to the turning part or the free end of the enlarged section is flush with the turning part. When the occlusion device is not squeezed by a radial force, the second conical cavity has a third taper angle. When the occlusion device is squeezed by a radial force, the outer side surface of the enlarged section extends distally, and the second conical cavity has a fourth taper angle, and the fourth taper angle is smaller than the third taper angle. Since the taper angle of the first conical cavity or the second conical cavity can change following the deformation of the enlarged section when the occlusion device is squeezed by a radial force (the angle of the inner side surface or the outer side surface of the enlarged section changes after the occlusion device is subjected to a radial force), on the one hand, the deformation ability of the enlarged section is improved, and on the other hand, the conformability of the occlusion device to the aneurysm cavity is improved.

[0030] The present invention also discloses a system for occluding an aneurysm, which includes:

[0031] The aneurysm occlusion device as described above, and

[0032] A delivery member or a detachment member corresponding to the aneurysm occlusion device.

[0033] Further, the aneurysm is an intracranial bifurcation wide-neck aneurysm.

[0034] The technical solution of the present invention has the following advantages:

[0035] The system for occluding an aneurysm provided by the present invention has all the advantages of the aforementioned aneurysm occlusion device. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0037] Figure 1 Schematic cross-sectional view of the plugging device disclosed in Embodiment 1 of the present invention;

[0038] Figure 2 Schematic diagram of the change in the configuration of the plugging device disclosed in Embodiment 1 of the present invention before and after being radially compressed. The solid line represents the configuration before being stressed, and the dashed line represents the configuration after being stressed;

[0039] Figure 3 Schematic diagram of the configuration of the plugging device disclosed in Embodiment 1 of the present invention when being radially compressed in the aneurysm;

[0040] Figure 4 Schematic cross-sectional view of the plugging device disclosed in Embodiment 2 of the present invention;

[0041] Figure 5 For Figure 4 Schematic diagram of the configuration of the plugging device in the aneurysm when being radially compressed;

[0042] Figure 6 Front view of the plugging device disclosed in Embodiment 3 of the present invention;

[0043] Figure 7 Stereoscopic diagram of the plugging device disclosed in Embodiment 3 of the present invention;

[0044] Figure 8 Cross-sectional view of the plugging device disclosed in Embodiment 3 of the present invention;

[0045] Figure 9 Schematic diagram of the change in the configuration of the plugging device disclosed in Embodiment 3 of the present invention before and after being radially compressed. The solid line represents the configuration before being stressed, and the dashed line represents the configuration after being stressed;

[0046] Figure 10 Schematic diagram of the plugging device disclosed in Embodiment 3 of the present invention being compressed and held in the delivery catheter, showing its cooperation with the delivery catheter and the pusher wire;

[0047] Figure 11 Schematic diagram of the shape of a part of the plugging device disclosed in Embodiment 3 of the present invention after being pushed out of the delivery catheter;

[0048] Figure 12Schematic diagram of the shape of the smaller-sized occlusion device disclosed in Embodiment 3 of the present invention located within a larger-sized aneurysm;

[0049] Figure 13 Schematic diagram of the shape of the larger-sized occlusion device disclosed in Embodiment 3 of the present invention located within a smaller-sized aneurysm;

[0050] Figure 14 Cross-sectional schematic diagram of the occlusion device disclosed in Embodiment 4 of the present invention;

[0051] Figure 15 Cross-sectional schematic diagram of the occlusion device disclosed in Embodiment 5 of the present invention;

[0052] Figure 16 Cross-sectional schematic diagram of the occlusion device disclosed in Embodiment 6 of the present invention.

[0053] Explanation of reference numerals:

[0054] A, inner cavity; B, outer surface of the extension section; C, inner surface of the extension section; X, inner surface of the enlarged section; Y, outer surface of the enlarged section; 1, connecting portion; 3, extension section; 32, turning portion; 4, enlarged section; 40, free end; 42, annular opening; 43, first conical cavity; 44, second conical cavity; 45, depression of the enlarged section; 50, aneurysm wall; 51, aneurysm cavity; 52, aneurysm neck opening; 53, aneurysm apex; 6, delivery member; 61, pushing wire; 62, delivery catheter. Detailed implementation manners

[0055] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0056] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "vertical", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus cannot be construed as a limitation of the present invention. In addition, the terms "first", "second", "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance. The term "axial direction" refers to the direction along the center line of the aneurysm occlusion device.

[0057] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0058] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0059] like Figures 1 to 16 As shown, the present invention provides a system for occluding an aneurysm, comprising an aneurysm occluding device, a delivery member 6 or a release member corresponding to the aneurysm occluding device. The aneurysm is a wide-necked aneurysm at an intracranial bifurcation.

[0060] The occluding device has three forms, one is a slender configuration that is constructed with radial compression and suitable for delivery (also referred to as a delivery form), one is an expansion configuration that is elastically transformed from a slender configuration to a radial expansion (also referred to as a free expansion form, in which the occluding device is not squeezed by external forces), and the other is a tumor wall extrusion form. In this embodiment, the occluding device is a double-layer structure obtained by pre-shaping a double-layer braided mesh (for example, heat setting, which can be performed twice or three or even more times). The double-layer braided mesh is a double-layer structure nested inside and outside formed by folding a single-layer braided mesh. 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 number of braided strands of the double-layer braided mesh can be selected to be 48 strands, 64 strands, 72 strands, 96 strands, 108 strands or 116 strands, the diameter of the braided wire can be selected from 0.0006 inches to 0.014 inches, and the braided wire is made of metal material or polymer material. In other embodiments, the blocking device is a single-layer structure, specifically, the single-layer structure is pre-shaped by an elastic tube body with non-uniform wall thickness.

[0061] 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.

[0062] The occluding device in the expanded configuration includes a proximal converging section (not shown, which is received within the connecting portion 1), an extending section 3, an enlarged section 4 extending from the distal end of the extending section 3, and a connecting portion 1 that are connected in sequence. The extending section 3 and the enlarged section 4 circumferentially enclose to form an inner cavity A. In this embodiment, the extending section 3 extends from a position near the axis in a direction away from the axis, and the enlarged section 4 extends from a position away from the axis in a direction towards the axis. The extending section 3 and the enlarged section 4 enclose to form a shape similar to "<>" in cross-section.

[0063] The connecting portion 1 fixes and tightens the converging section, that is, it ties and gathers the ends of the inner and outer braided wires, preventing the double-layer braided mesh from spreading. The connecting portion 1 is preferably made of a material that is visible under X-ray for easy positioning. The connecting portion 1 is detachably connected to the pusher wire 61 to facilitate the delivery and implantation of the occluding device into the aneurysm. In this embodiment, the inner and outer layers of the extending section 3 are described as being spaced apart from each other or equidistantly arranged along its length. In other embodiments, the inner and outer layers of the extending section 3 may be in contact with each other or non-equidistantly arranged along all or part of its length. Specifically, for example, the inner layer may press radially outward against the outer layer.

[0064] The extending section 3 extends upward from the converging section and is generally bowl-shaped. Although Figure 1 -4 depicts the extending section 3 as having an arc protruding proximally at the bottom (i.e., the bottom is concave when the occluding device is placed vertically), in other embodiments, the bottom may have an arc protruding distally (i.e., the bottom is convex when the occluding device is placed vertically), or the bottom may be flat. For the convenience of the following description, the connection between the distal end of the extending section 3 and the enlarged section 4 is defined as the turning portion 32. Additionally, the extending section 3 has an outer side surface B of the extending section (as Figure 1 shown) and an inner side surface C of the extending section (as Figure 1 shown).

[0065] The enlarged section 4 extends from a position away from the axis towards the axis of the occluding device (as shown by the dashed lines in Figure 1 , Figure 4 and Figure 8 ).

[0066] Figures 1 to 3 Fig. shows Embodiment 1 of the occluding device disclosed in the present invention. In this embodiment, the free end 40 of the enlarged section 4 is flush with the turning portion 32. The enlarged section 4 and the extending section 3 circumferentially enclose to form an inner cavity A. The free end 40 of the enlarged section 4 circumferentially encloses to form an annular opening 42, and the annular opening 42 communicates with the inner cavity A. In Figure 1 , the inner side surface X of the enlarged section 4 slightly arches distally, and the outer side surface Y of the enlarged section 4 significantly arches distally. In Figure 2In it, the inner side surface X of the swelling section 4 arches towards the proximal end, the outer side surface Y of the swelling section arches towards the distal end, the inner side surface X of the swelling section circumferentially encloses to form a second tapered cavity 44, and the second tapered cavity 44 has a third taper angle θ3. Continue to refer to Figure 2 , which gives the morphological diagrams of the occlusion device before and after being squeezed in the form of a comparison. It can be seen from Figure 2 that after being squeezed, the annular opening 42 becomes smaller and moves towards the distal end, and the taper angle of the second tapered cavity 44 becomes smaller to a fourth taper angle θ4. In this embodiment, the second tapered cavity 44 is formed by enclosing the tangents of the corresponding points on the circumferential direction of the inner side surface X of the swelling section. In order to compare the change of the taper angle, a fixed point needs to be used as a reference.

[0067] When the occlusion device is placed in the aneurysm, as shown in Figure 3 , the extension section 3 occludes the aneurysm neck opening 52. Due to the size difference (the width of the occlusion device in the expanded configuration is greater than the width of the aneurysm), the occlusion device provides a radially outward expanding supporting force while being subjected to the radially inward squeezing force of the aneurysm wall 50. Inside the aneurysm, the occlusion device is in the form of being squeezed by the aneurysm wall. Compared with the freely deployed form, the annular opening 42 will become smaller or closed. In this way, the channel for blood to flow towards the aneurysm top 53 via the annular opening 42 can be reduced or even blocked, leaving more blood or even completely leaving the blood in the inner cavity A, reducing or blocking the impact of blood on the aneurysm top 53, and avoiding the further expansion of the aneurysm. In addition, the deformation of the annular opening 42 can enable the occlusion device to adapt to aneurysm cavities 51 of different sizes, and the radially outward acting force generated by the reduction of the annular opening 42 can provide a radial supporting force for the occlusion device, preventing the extension section 3 from falling off from the aneurysm neck opening 52 due to insufficient supporting force.

[0068] Figure 4 And Figure 5 shows Embodiment 2 of the occlusion device disclosed in the present invention. Refer to Figure 4 , the free end 40 of the swelling section 4 faces the distal end relative to the turning section 32. The free end 40 of the swelling section 4 circumferentially encloses to form an annular opening 42. The inner side surface X of the swelling section 4 arches towards the proximal end, and the outer side surface Y of the swelling section arches towards the distal end. The inner side surface X of the swelling section circumferentially encloses to form a second tapered cavity 44, and the second tapered cavity 44 has a third taper angle θ3. In this embodiment, the second tapered cavity 44 is formed by enclosing the tangents of the corresponding points on the circumferential direction of the inner side surface X of the swelling section. In order to compare the change of the taper angle, a fixed point needs to be used as a reference.

[0069] Refer to Figure 5, when the occlusion device is placed inside the aneurysm, the extension section 3 occludes the aneurysm neck opening 52. The occlusion device radially contracts under the radial extrusion force of the aneurysm wall 50, and the outer side surface Y of the enlarged section extends towards the distal end. The contact area between the occlusion device and the aneurysm wall 50 increases, which can, to a certain extent, relieve the pressure of the blood flowing into the aneurysm on the aneurysm wall 50 and prevent the further growth of the aneurysm. Additionally, the inner side surfaces X of the enlarged section approach each other circumferentially, and the taper angle of the second tapered cavity 44 correspondingly decreases to the fourth taper angle θ4, and the annular opening 42 also becomes smaller accordingly. Even the inner side surfaces X of the enlarged section abut against each other, closing the annular opening 42, thereby narrowing or even blocking the channel through which the blood flows towards the aneurysm apex 53 via the annular opening 42, retaining more blood or even all the blood inside the inner cavity A, reducing or blocking the impact of the blood on the aneurysm wall 50 and the aneurysm apex 53, and avoiding the further expansion of the aneurysm. Moreover, the deformation of the annular opening 42 and the change in the taper angle of the second tapered cavity 44 enable the occlusion device to adapt to aneurysm cavities 51 of different sizes. The radially outward acting force generated by the reduction of the annular opening 42 and the decrease in the taper angle of the second tapered cavity 44 can provide a radial support force for the occlusion device, preventing the extension section 3 from detaching from the aneurysm neck opening 52 due to insufficient support force. Additionally, in extreme cases, such as when the inner side surfaces X of the enlarged section of the occlusion device abut against each other, a greater radial support force can be provided for the occlusion device. Furthermore, the inner side surfaces X of the enlarged section arch towards the proximal end, which can also provide a component force for the extension of the outer side surface Y of the enlarged section towards the distal end, ultimately enhancing the deformation ability of the entire occlusion device and its conformability to the aneurysm.

[0070] Figures 6 to 9 Fig. 4 shows Embodiment 3 of the occlusion device disclosed in the present invention. In this embodiment, the free end 40 of the enlarged section 4 faces the proximal end relative to the turning portion 32. The free end 40 of the enlarged section 4 circumferentially encloses to form an annular opening 42. The annular opening 42 communicates with the inner cavity A. The inner side surface X of the enlarged section 4 of the enlarged section arches towards the proximal end, and the outer side surface Y of the enlarged section arches towards the distal end. Refer to Figure 9 , the outer side surface Y of the enlarged section circumferentially encloses to form a first tapered cavity 43, and the first taper angle of the first tapered cavity 43 is θ1. In this embodiment, the second tapered cavity 44 is formed by the tangents of the corresponding points on the circumference of the outer side surface Y of the enlarged section. To compare the change in the taper angle, a fixed point needs to be used as a reference.

[0071] Refer to Figure 9 , which presents, in an exaggerated manner, the change in the configuration of the occlusion device before and after being subjected to a radial extrusion force, wherein the annular opening 42 becomes smaller and moves towards the proximal end. It can be understood that Figure 9 also shows two configurations of the occlusion device in the freely deployed state (shown by the solid line) and the state of being squeezed by the aneurysm wall (shown by the dashed line).

[0072] When the occlusion device is in the aneurysm, the extension section 3 occludes the aneurysm neck opening 52. When the occlusion device is subjected to a radial squeezing force, the free end 40 of the enlarged section extends proximally, causing the inner side X of the enlarged section to gradually approach the extension section 3, and the annular opening 42 to move proximally. At the same time, the outer sides Y of the enlarged section abut against each other. When the radial squeezing force is large enough, the inner side X of the enlarged section abuts against the extension section 3, and the outer sides Y of the enlarged section abut against each other. The taper angle of the first conical cavity 43 becomes smaller to the second taper angle θ2, thereby narrowing or even closing the channel through which blood flows distally via the annular opening 42, retaining more blood or even all the blood in the inner cavity A, reducing or blocking the impact of blood on the aneurysm wall 50, and preventing further enlargement of the aneurysm. Moreover, the change in the taper angle of the first conical cavity 43 and the deformation of the annular opening 42 enable the occlusion device to adapt to aneurysm cavities 51 of different sizes. After the annular opening 42 decreases, its elastic restoring force can provide a radial supporting force for the occlusion device, preventing the extension section 3 from detaching from the aneurysm neck opening 52 due to insufficient supporting force. In particular, when the occlusion device is subjected to a large radial squeezing force and the outer sides Y of the enlarged section abut against each other, a greater radial supporting force can be provided for the occlusion device. Additionally, the inner side X of the enlarged section arches proximally, enabling the enlarged section 4 to quickly abut against the extension section 3 and promptly providing a radial supporting force for the extension section 3, preventing the extension section 3 from deforming excessively inward in the radial direction and detaching from the aneurysm neck opening 52. Furthermore, the approach and even abutment of the enlarged section 4 to the extension section 3 can form multiple barriers to blood at the aneurysm neck opening 52, further reducing the blood entering the aneurysm cavity 51 and further promoting the healing of the aneurysm. In this embodiment, if the size of the aneurysm is large (as shown in Figure 12 ), the reduction amplitude of the annular opening 42 is small; if the size of the aneurysm is small (as shown in Figure 13 ), the reduction amplitude of the annular opening 42 increases, and the annular opening 42 even closes.

[0073] In the above three embodiments, the distal end of the occlusion device after deformation does not contact the aneurysm apex 53 at the center of the top.

[0074] The following takes the occlusion device in Embodiment 3 as an example to introduce the usage process of the aneurysm occlusion device provided in this embodiment:

[0075] First, position the distal end of the delivery catheter 62 into the aneurysm, and then push the pusher wire 61 along the delivery catheter 62 to release the occlusion device from the delivery catheter 62 into the aneurysm. The schematic diagram of the partial deployment of the occlusion device is as shown in Figure 11 . When the occlusion device completely enters the aneurysm, due to the restriction of the aneurysm wall 50, the occlusion device cannot expand into a freely deployed form. The extension section 3 of the occlusion device occludes the aneurysm neck opening 52, and the occlusion device stays in the aneurysm cavity 51, in the form of being squeezed by the aneurysm wall, Figure 12 and Figure 13Respectively give the deformation diagrams of the occlusion device under two extrusion degrees;

[0076] After the occlusion device is in place, the release member releases (which can be electrolytic release or mechanical release) the connection between the connecting portion 1 and the pusher wire 61, withdraws the pusher wire 61, and then withdraws the delivery catheter 62 to complete the placement of the occlusion device.

[0077] For the aneurysm occlusion device provided in this embodiment, compared with the occlusion device without a swelling section, the setting of the swelling section 4 divides a single chamber into at least two sub-chambers with smaller volumes or multiple sub-chambers connected by narrow channels. The neck of the aneurysm 52 is blocked by the extension section 3, and the role of the spatial division of the chamber space of the swelling section 4 makes the blood flow in the aneurysm cavity 51 slower; in addition, due to the presence of the swelling section 4 in the aneurysm cavity 51, it plays a role similar to that of a coil, which is conducive to the formation of thrombus; furthermore, the annular opening 42 formed by the circumferential enclosure of the free end 40 of the swelling section 4 can elastically become smaller when the occlusion device is implanted into the aneurysm and is subjected to radial extrusion force, and can elastically become larger when the size of the aneurysm increases unexpectedly. On the one hand, the elastic force / support force is transmitted to the extension section 3 through the swelling section 4 to provide better support, adapt to the patient's life cycle, and prevent the occlusion device from falling off from the neck of the aneurysm 52. On the other hand, the same-sized occlusion device can be adapted to multiple aneurysms of different sizes, that is, when the same-sized occlusion device is placed in aneurysms of different sizes, the size of the annular opening 42 is different.

[0078] The aneurysm occlusion device provided in this embodiment can simultaneously take into account the conformability of the occlusion device, the dense mesh filling in the aneurysm, and the requirement of increasing the metal coverage rate at the neck of the aneurysm 52, which can further interfere with the blood flow change in the aneurysm, accelerate the formation of natural thrombus in the aneurysm cavity 51, and improve the timeliness of treating aneurysms. In addition, the aneurysm occlusion device provided in this embodiment is a configuration obtained by folding a single-layer braided mesh to form a double-layer braided mesh structure with inner and outer nesting and then performing secondary heat setting. Compared with the single-layer configuration, it can obtain greater aneurysm support performance, increase the stability of the occlusion device in the aneurysm cavity 51, and increase the metal coverage rate at the neck of the aneurysm 52, further hindering the blood flow entering the aneurysm cavity 51. Furthermore, the setting of the swelling section 4 with a hollow interior can not only realize the filling of the metal dense mesh in the aneurysm cavity 51, but also divide the space of the aneurysm cavity 51, increase the resistance of the blood flow in the aneurysm, accelerate the formation of thrombus in the aneurysm cavity 51, and promote the rapid healing of the aneurysm.

[0079] In addition, refer to Figures 14 to 16 , other embodiments of the occlusion device are given. Specifically, Figure 14 the occlusion device in Figure 15There are two swelling section recesses 45 provided on the swelling section 4 therein. Of course, there can be more. The swelling section recess 45 is locally recessed from the outer surface Y of the swelling section towards the inner surface X of the swelling section. Figure 16 There are two swelling sections 4 therein. And there are two swelling section recesses 45 provided on the upper swelling section 4. Of course, in other embodiments, at least one extension section recess can also be formed by recessing from the outer surface B of the extension section 3 (as shown in 1) towards the inner surface C of the extension section (as Figure 1 shown in). This can improve the deformation ability of the extension section 3.

[0080] Obviously, the above embodiments are merely examples given for clear illustration and are not limitations on the embodiments. For those of ordinary skill in the art, other different forms of changes or variations can be made based on the above description. It is not necessary and impossible to list all the embodiments here. And the obvious changes or variations derived therefrom are still within the protection scope of the present invention.

Claims

1. An aneurysm occlusion device, characterized in that, the aneurysm occlusion device is configured to have an elongated configuration suitable for delivery with radial compression, and elastically transform from the elongated configuration to a radially expanded expanded configuration, the expanded configuration including a converging portion at the proximal end, an extension section (3), and a swelling section (4) connected to the distal end of the extension section (3) connected in sequence. The extension section (3) and the swelling section (4) circumferentially enclose to form an inner cavity (A). The swelling section (4) extends towards the axis of the occlusion device. The swelling section (4) has a swelling section inner side surface (X) facing the inner cavity (A) and a swelling section outer side surface (Y) facing away from the inner cavity (A). The free end (40) of the swelling section (4) circumferentially encloses to form an annular opening (42) communicating with the inner cavity (A).

2. The aneurysm occlusion device according to claim 1, characterized in that, when the occlusion device is in the expanded configuration, the extension section (3) extends from a position near the axis towards a direction away from the axis, and the swelling section (4) extends from a position away from the axis towards the axis.

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

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

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

6. The aneurysm occlusion device according to claim 1, characterized in that, when the occlusion device is in a non-elongated configuration, the swelling section outer side surface (Y) circumferentially encloses to form a first tapered cavity (43), the tip of the first tapered cavity (43) faces the proximal end and communicates with the annular opening (42), or, the swelling section inner side surface (X) circumferentially encloses to form a second tapered cavity (44), the tip of the second tapered cavity (44) faces the distal end and communicates with the annular opening (42).

7. The aneurysm occlusion device according to claim 6, characterized in that, the connection part of the extension section (3) and the swelling section (4) is a turning part (32). In the direction parallel to the axis of the occlusion device, the free end (40) of the swelling section (4) is towards the proximal end relative to the turning part (32), or the free end (40) of the swelling section (4) is towards the distal end relative to the turning part (32), or the free end (40) of the swelling section (4) is flush with the turning part (32).

8. The aneurysm occlusion device according to claim 7, characterized in that, The free end (40) of the enlarged section (4) faces the proximal end relative to the turning portion (32). When the occlusion device is radially squeezed, the inner side surface (X) of the enlarged section approaches the extension section (3), and the outer side surfaces (Y) of the enlarged section approach each other circumferentially.

9. The aneurysm occlusion device according to claim 8, wherein: When the occlusion device is not radially squeezed, the first tapered cavity (43) has a first taper angle. When the occlusion device is radially squeezed, the first tapered cavity (43) has a second taper angle, and the second taper angle is smaller than the first taper angle.

10. The aneurysm occlusion device according to claim 7, wherein: The free end (40) of the enlarged section (4) faces the distal end relative to the turning portion (32), or the free end (40) of the enlarged section (4) is flush with the turning portion (32). When the occlusion device is radially squeezed, the outer side surface (Y) of the enlarged section extends towards the distal end.

11. The aneurysm occlusion device according to claim 10, wherein: When the occlusion device is not radially squeezed, the second tapered cavity (44) has a third taper angle. When the occlusion device is radially squeezed, the second tapered cavity (44) has a fourth taper angle, and the fourth taper angle is smaller than the third taper angle.

12. The aneurysm occlusion device according to any one of claims 8 - 11, wherein: When the occlusion device is radially squeezed, the annular opening (42) closes.

13. The aneurysm occlusion device according to claim 1, wherein: Both the inner side surface (X) of the enlarged section and the outer side surface (Y) of the enlarged section are arc-shaped surfaces, both arching towards the distal end, or the inner side surface (X) of the enlarged section arches towards the proximal end, and the outer side surface (Y) of the enlarged section arches towards the distal end.

14. The aneurysm occlusion device according to claim 1, wherein: 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.

15. The aneurysm occlusion device according to claim 1, wherein: The number of the enlarged sections (4) is at least two, and at least two of the enlarged sections (4) are vertically spaced along the axial direction.

16. The aneurysm occlusion device according to claim 1, wherein: At least one enlarged-section recess (45) is formed by the outer side surface (Y) of the enlarged section (4) partially recessing towards the inner side surface (X) of the enlarged section or the inner side surface (X) of the enlarged section partially recessing towards the outer side surface (Y) of the enlarged section, and / or At least one extension-section recess is formed by the outer side surface (B) of the extension section (3) partially recessing towards the inner side surface (C) of the extension section, or the inner side surface (C) of the extension section (3) partially recessing towards the outer side surface (B) of the extension section.

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

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

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