WO2025113719A1 - Aneurysm occlusion apparatus and system for aneurysm occlusion - Google Patents

Abstract

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

Description

Aneurysm occlusion device and system for occluding aneurysm

CROSS-REFERENCE TO RELATED APPLICATIONS

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

Technical Field

The present application relates to the technical field of occluding devices, and in particular to an aneurysm occluding device and a system for occluding an aneurysm.

Background Art

Intracranial aneurysm is a common intracranial disease. The prevalence of aneurysms is about 7%-9%. The presence of intracranial aneurysms in the human body brings great risks to people. Once an aneurysm ruptures, it will cause hemorrhagic stroke, causing the patient to fall into a coma or even be in danger of death, posing a huge threat to people's health.

At present, the main methods for treating aneurysms are: surgical clipping, coils with auxiliary stents, and intra-tumor flow-disturbing braids. Among them, surgical clipping has extremely high surgical risks and high surgical costs, which puts great economic and mental pressure on patients; coils with auxiliary stents are a relatively good interventional treatment for aneurysms, but coils with auxiliary stents are not suitable for the treatment of bifurcated wide-necked aneurysms. For bifurcated wide-necked aneurysms, a company took the lead in proposing a lantern-shaped intra-tumor 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 and models need to be designed to adapt to different aneurysms, and the conformability is poor. Later, another company designed another typical occlusion device, whose design configuration is similar to an open bowl, mainly used to block the neck of the aneurysm. Because it is an open design, only the size of the neck of the aneurysm needs to be considered, and the shape of the aneurysm 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 the former. However, the bowl-shaped occluding device has a dense metal mesh only distributed at the neck of the tumor, and there is no filler inside the tumor. Due to the inevitable blood flow through the occluding device into the tumor and/or the existence of vortexes inside the tumor, the period for blood to form thrombus inside the tumor may be longer than that of an occluding device with fillers. In addition, the bowl-shaped occluding device has no support and relies solely on the bowl-shaped side wall to adhere to the tumor wall, which may be at risk of falling off in the long term.

Therefore, it is necessary to design an aneurysm occlusion device and a system for occluding an aneurysm to solve the above problems.

Summary of the invention

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

To solve the above technical problems, the technical solution of this application is as follows:

An aneurysm occluding device is constructed to have a slender configuration that is radially compressed and suitable for delivery, and an expanded configuration that is elastically transformed from the slender configuration to a radially expanded configuration, the expanded configuration includes a gathering portion located at the proximal end, an extension segment, and an expansion segment connected to the distal end of the extension segment in sequence, the expansion segment extends toward the axis of the occluding device, the expansion segment has an inner side surface of the expansion segment facing the inner cavity and an outer side surface of the expansion segment facing away from the inner cavity, the extension segment and the expansion segment circumferentially enclose the inner cavity, and the free end of the expansion segment circumferentially encloses a ring-shaped opening connected to the inner cavity.

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

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

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

Optionally, the annular opening moves proximally or distally.

Optionally, when the blocking device is in a non-slender configuration, the outer side surface of the expansion section circumferentially encloses a first conical cavity, the tip of the first conical cavity faces the proximal end and is connected to the annular opening, or the inner side surface of the expansion section circumferentially encloses a second conical cavity, the tip of the second conical cavity faces the distal end and is connected to the annular opening.

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

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

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

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

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

Optionally, when the blocking device is squeezed by radial force, the annular opening is closed.

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

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

Optionally, the number of the enlarged sections is at least two, and at least two of the enlarged sections are vertically spaced apart along the axial direction.

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

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

The technical solution of this application has the following advantages:

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

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

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

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

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

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

An aneurysm occlusion device as described above, and

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

Optionally, the aneurysm is an intracranial bifurcation wide-necked aneurysm.

The technical solution of this application has the following advantages:

The system for occluding an aneurysm provided in the present application has all the advantages of the aforementioned aneurysm occlusion devices.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the specific implementation methods of the present application or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

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

FIG2 is a schematic diagram of the configuration change of the blocking device disclosed in the first embodiment of the present application before and after being radially squeezed, wherein the solid line represents the configuration before being subjected to force, and the dotted line represents the configuration after being subjected to force;

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

FIG4 is a cross-sectional schematic diagram of a blocking device disclosed in Embodiment 2 of the present application;

FIG5 is a schematic diagram of the configuration of the occlusion device in FIG4 being radially squeezed in an aneurysm;

FIG6 is a front view of the blocking device disclosed in Embodiment 3 of the present application;

FIG7 is a perspective schematic diagram of a blocking device disclosed in Embodiment 3 of the present application;

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

9 is a schematic diagram of the configuration change of the blocking device disclosed in the third embodiment of the present application before and after being radially squeezed, where the solid line represents the configuration before being subjected to force, and the dotted line represents the configuration after being subjected to force;

FIG. 10 is a schematic diagram showing the blocking device disclosed in the third embodiment of the present application being pressed and gripped in the delivery catheter and cooperating with the delivery catheter and the push wire;

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

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

FIG13 is a schematic diagram of a larger occlusion device according to Embodiment 3 of the present application located in an aneurysm of smaller size;

FIG14 is a cross-sectional schematic diagram of a blocking device disclosed in Embodiment 4 of the present application;

FIG15 is a cross-sectional schematic diagram of a blocking device disclosed in Embodiment 5 of the present application;

FIG16 is a cross-sectional schematic diagram of the blocking device disclosed in Embodiment 6 of the present application.

Description of reference numerals:
A, inner cavity; B, outer side of the extension section; C, inner side of the extension section; X, inner side of the enlarged section; Y, outer side of the enlarged section; 1, connecting part;
3. Extension section; 32. Turning point; 4. Expansion section; 40. Free end; 42. Annular opening; 43. First conical cavity; 44. Second conical cavity; 45. Concave portion of expansion section; 50. Tumor wall; 51. Tumor cavity; 52. Tumor neck; 53. Tumor top; 6. Delivery member; 61. Push wire; 62. Delivery catheter.

DETAILED DESCRIPTION

The technical solution of the present application will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present application.

In the description of the present application, it should be noted that the terms "center", "upper", "vertical", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application 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 therefore cannot be understood as a limitation on the present application. In addition, the terms "first", "second", and "third" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance, and the term "axial" refers to the direction along the centerline of the aneurysm occlusion device.

In the description of this application, 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 this application can be understood according to specific circumstances.

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

As shown in Figures 1 to 16, the present application provides a system for occluding an aneurysm, including an aneurysm occluding device, and 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.

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.

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.

The occluding device in the expanded configuration includes a gathering section (not shown, the gathering section is accommodated in the connecting portion 1) located at the proximal end, an extension section 3, an enlarged section 4 extending from the distal end of the extension section 3, and a connecting portion 1, which are connected in sequence. The extension section 3 and the enlarged section 4 are circumferentially enclosed to form an inner cavity A. In this embodiment, the extension section 3 extends from a position near the axis toward a direction away from the axis, and the enlarged section 4 extends from a position away from the axis toward the axis. The extension section 3 and the enlarged section 4 are enclosed to form a shape similar to "<>" in cross section.

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

The extension section 3 is formed by extending upward from the gathering section, and is generally bowl-shaped. Although the extension section 3 in Figures 1 to 4 is depicted as having a bottom (i.e., the vicinity of the area connected to the connecting portion 1) that is arc-shaped and protrudes toward the proximal end (i.e., the bottom is concave when the blocking device is placed vertically), in other embodiments, the bottom may be arc-shaped and protrudes toward the distal end (i.e., the bottom is convex when the blocking 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 extension section 3 and the expanded section 4 is defined as the turning section 32. In addition, the extension section 3 has an outer side surface B of the extension section (as shown in Figure 1) and an inner side surface C of the extension section (as shown in Figure 1).

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

FIG. 1 to FIG. 3 show the first embodiment of the occluding device disclosed in the present application. In this embodiment, the free end 40 of the expanded section 4 is flush with the turning portion 32, the expanded section 4 and the extension section 3 are circumferentially enclosed to form an inner cavity A, and the free end 40 of the expanded section 4 is circumferentially enclosed to form an annular opening 42, and the annular opening 42 is connected to the inner cavity A. In FIG. 1, the expanded section inner side surface X of the expanded section 4 is slightly arched toward the distal end, and the expanded section outer side surface Y is obviously arched toward the distal end. In FIG. 2, the expanded section inner side surface X of the expanded section 4 is arched toward the proximal end, and the expanded section outer side surface Y is arched toward the distal end. The expanded section inner side surface X is circumferentially enclosed to form a second tapered cavity 44, and the second tapered cavity 44 has a third taper angle θ3. Continuing to refer to FIG. 2, the morphological diagram of the occluding device before and after being squeezed is given in the form of comparison. It can be seen from FIG. 2 that after being squeezed, the annular opening 42 becomes smaller and moves toward 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 the tangent lines of the corresponding points on the inner side surface X of the expanded section in the circumferential direction. In order to compare the change of the taper angle, a fixed point needs to be used as a reference.

When the occluding device is placed in the aneurysm, as shown in FIG3 , the extension section 3 blocks the aneurysm neck 52. Due to the size difference (the width of the occluding device in the expanded configuration is greater than the width of the aneurysm), the occluding device provides radial outward expansion support force while being subjected to the radial inward squeezing force of the aneurysm wall 50. In the aneurysm, the occluding device is in the aneurysm wall squeezing form. Compared with the free expansion form, the annular opening 42 will become smaller or closed. In this way, the passage for blood to flow toward the aneurysm top 53 through the annular opening 42 can be reduced or even blocked, and more blood or even completely blood can be left in the inner cavity A, reducing or blocking the impact of blood on the aneurysm top 53, and preventing the aneurysm from further expanding. In addition, the deformation of the annular opening 42 can make the occluding device adapt to aneurysm cavities 51 of different sizes. The radial outward force generated by the reduction of the annular opening 42 can provide radial support force for the occluding device, preventing the extension section 3 from falling off from the aneurysm neck 52 of the aneurysm due to insufficient support force.

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

Referring to FIG5 , when the occluding device is placed in the aneurysm, the extension section 3 occludes the aneurysm neck 52, the occluding device contracts radially due to the radial squeezing force of the aneurysm wall 50, and the outer side surface Y of the enlarged section extends toward the distal end, and the contact area between the occluding device and the aneurysm wall 50 increases, which can relieve the pressure of the blood flow entering the aneurysm on the aneurysm wall 50 to a certain extent, and prevent the aneurysm from growing further. In addition, the inner side surfaces X of the enlarged section are close to each other in the circumferential direction, and the taper angle of the second tapered cavity 44 is correspondingly reduced to the fourth taper angle θ4, and the annular opening 42 is also correspondingly reduced, and even the inner side surfaces X of the enlarged section are abutted against each other, so that the annular opening 42 is closed, thereby reducing or even sealing the channel for blood to flow toward the aneurysm top 53 through the annular opening 42, leaving more blood or even completely in the inner cavity A, reducing or blocking the impact of blood on the aneurysm wall 50 and the aneurysm top 53, and preventing the aneurysm from further expanding. Moreover, the deformation of the annular opening 42 and the change of the taper angle of the second tapered cavity 44 can make the occluding device adapt to aneurysm cavities 51 of different sizes. The radial outward force generated by the reduction of the annular opening 42 and the reduction of the taper angle of the second tapered cavity 44 can provide radial support for the occluding device, thereby preventing the extension section 3 from falling off from the aneurysm neck 52 of the aneurysm due to insufficient support. In addition, in extreme cases, such as when the inner side surfaces X of the enlarged section of the occluding device are pressed against each other, a greater radial support can be provided for the occluding device. Furthermore, the inner side surface X of the enlarged section arches toward the proximal end, and can also provide a component force for the inner side surface X of the enlarged section to extend toward the distal end, thereby ultimately improving the deformation ability and conformability of the entire occluding device to the aneurysm.

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

Referring to Fig. 9, the change in configuration of the occluding device before and after being subjected to radial extrusion force is presented in an exaggerated manner, wherein the annular opening 42 becomes smaller and moves toward the proximal end. It can be understood that Fig. 9 also shows two configurations of the occluding device in a free deployment configuration (shown by the solid line) and a tumor wall extrusion configuration (shown by the dotted line).

When the occluding device is placed in the aneurysm, the extension section 3 blocks the aneurysm neck 52. When the occluding device is subjected to radial extrusion force, the free end 40 of the expanded section extends toward the proximal end, so that the inner side surface X of the expanded section gradually approaches the extension section 3, and the annular opening 42 moves toward the proximal end. At the same time, the outer side surfaces Y of the expanded section abut against each other. When the radial extrusion force is large enough, the inner side surface X of the expanded section abuts against the extension section 3, and the outer side surfaces Y of the expanded section abut against each other, and the taper angle of the first tapered cavity 43 decreases to the second taper angle θ2, thereby reducing or even blocking the channel for blood to flow toward the distal end through the annular opening 42, leaving more blood or even completely in the inner cavity A, reducing or blocking the impact of blood on the aneurysm wall 50, and preventing the aneurysm from further expanding. Moreover, the change of the taper angle of the first conical cavity 43 and the deformation of the annular opening 42 can make the occluding device adapt to the aneurysm cavity 51 of different sizes. After the annular opening 42 is reduced, its elastic restoring force can provide radial support force for the occluding device, and prevent the extension section 3 from falling off from the aneurysm neck 52 due to insufficient support force. In particular, when the occluding device is subjected to a large radial extrusion force and the outer side surfaces Y of the expanded section abut against each other, a greater radial support force can be provided for the occluding device. In addition, the inner side surface X of the expanded section arches toward the proximal end, which can make the expanded section 4 quickly abut against the extension section 3, and timely provide radial support force for the extension section 3, so as to prevent the extension section 3 from excessively deforming inward in the radial direction and falling off from the aneurysm neck 52. Furthermore, the expanded section 4 approaches or even abuts against the extension section 3, which can form a multi-layer barrier to blood at the aneurysm neck 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 FIG. 12 ), the annular opening 42 does not shrink much; if the size of the aneurysm is small (as shown in FIG. 13 ), the annular opening 42 shrinks more and may even close.

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

The following uses the occluding device in Embodiment 3 as an example to introduce the use process of the aneurysm occluding device provided in this embodiment:

First, the distal end of the delivery catheter 62 is positioned inside the aneurysm, and then the push wire 61 is pushed along the delivery catheter 62 to release the occluding device from the delivery catheter 62 into the aneurysm. A schematic diagram of a partial deployment of the occluding device is shown in FIG11 . The occluding device completely enters the aneurysm. Due to the restriction of the aneurysm wall 50 , the occluding device cannot expand to a freely deployed form. The extension section 3 of the occluding device seals the aneurysm neck 52. The occluding device stays in the aneurysm cavity 51 and is in a state of aneurysm wall compression. FIG12 and FIG13 respectively show deformation diagrams of the occluding device under two compression degrees.

After the blocking device is in place, the release component releases (can be electrical or mechanical) the connection between the connecting portion 1 and the push wire 61, withdraws the push wire 61, and then withdraws the delivery catheter 62 to complete the placement of the blocking device.

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

The aneurysm occluding device provided in this embodiment can take into account the conformability of the occluding device, the dense mesh filling in the aneurysm, and the need to increase the metal coverage rate at the neck 52 of the aneurysm, which can further interfere with the blood flow changes in the aneurysm, accelerate the formation of natural thrombus in the aneurysm cavity 51, and improve the timeliness of treating the aneurysm. In addition, the aneurysm occluding device provided in this embodiment is a double-layer woven mesh structure formed by folding a single-layer woven mesh to form an inner and outer nested double-layer woven mesh structure, and then undergoing secondary heat setting. Compared with the single-layer configuration, it can obtain greater aneurysm support performance, increase the stability of the occluding device in the aneurysm cavity 51, and increase the metal coverage rate at the neck 52 of the aneurysm, further hindering the blood flow entering the aneurysm cavity 51. Furthermore, the setting of the internal hollow expansion section 4 can not only realize the filling of the metal dense mesh in the aneurysm cavity 51, but also divide the aneurysm cavity 51 into spaces, increase the resistance of blood flow in the aneurysm, accelerate the formation of thrombus in the aneurysm cavity 51, and promote the rapid healing of the aneurysm.

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

Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of this application.

Claims (18)

An aneurysm occluding device, characterized in that the aneurysm occluding device is constructed to have a slender configuration that is radially compressed and suitable for delivery, and an expansion configuration that is elastically transformed from the slender configuration to a radially expanded configuration, the expansion configuration includes a gathering portion located at the proximal end, an extension section (3), and an expansion section (4) connected to the distal end of the extension section (3) in sequence, the extension section (3) and the expansion section (4) circumferentially enclose an inner cavity (A), the expansion section (4) extends toward the axis of the occluding device, the expansion section (4) has an inner side surface (X) of the expansion section facing the inner cavity (A) and an outer side surface (Y) of the expansion section facing away from the inner cavity (A), and the free end (40) of the expansion section (4) circumferentially encloses a ring-shaped opening (42) connected to the inner cavity (A). The aneurysm occlusion device according to claim 1 is characterized in that, when the occlusion device is in an expanded configuration, the extension section (3) extends from a position near the axis toward a direction away from the axis, and the enlarged section (4) extends from a position away from the axis toward the axis. The aneurysm occlusion device according to claim 2 is characterized in that the width of the enlarged section (4) extending toward the axis is greater than the height of the enlarged section (4) extending along the axis. The aneurysm occlusion device according to claim 1 is characterized in that when the occlusion device is in an expanded configuration, the occlusion device is subjected to radial squeezing force and the annular opening (42) becomes smaller. The aneurysm occlusion device according to claim 4 is characterized in that the annular opening (42) moves toward the proximal end or the distal end. The aneurysm occluding device according to claim 1 is characterized in that, when the occluding device is in a non-slender configuration, the outer side surface (Y) of the enlarged section circumferentially encloses a first conical cavity (43), the tip of the first conical cavity (43) faces the proximal end and is connected to the annular opening (42), or, the inner side surface (X) of the enlarged section circumferentially encloses a second conical cavity (44), the tip of the second conical cavity (44) faces the distal end and is connected to the annular opening (42). The aneurysm occluding device according to claim 6 is characterized in that the portion on the extension section (3) where it is connected to the enlarged section (4) is a turning portion (32), and in a direction parallel to the axis of the occluding device, the free end (40) of the enlarged section (4) faces the proximal end relative to the turning portion (32), or the free end (40) of the enlarged section (4) faces the distal end relative to the turning portion (32), or the free end (40) of the enlarged section (4) is flush with the turning portion (32). The aneurysm occluding device according to claim 7 is characterized in that the free end (40) of the enlarged section (4) is oriented toward the proximal end relative to the turning portion (32), and when the occluding device is squeezed by radial force, 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 in the circumferential direction. The aneurysm occluding device according to claim 8 is characterized in that, when the occluding device is not squeezed by radial force, the first conical cavity (43) has a first taper angle, and when the occluding device is squeezed by radial force, the first conical cavity (43) has a second taper angle, and the second taper angle is smaller than the first taper angle. The aneurysm occluding device according to claim 7 is characterized in that the free end (40) of the expanded segment (4) is oriented toward the distal end relative to the turning portion (32), or the free end (40) of the expanded segment (4) is flush with the turning portion (32), and when the occluding device is squeezed by radial force, the outer surface (Y) of the expanded segment extends toward the distal end. The aneurysm occluding device according to claim 10 is characterized in that, when the occluding device is not squeezed by radial force, the second conical cavity (44) has a third taper angle, and when the occluding device is squeezed by radial force, the second conical cavity (44) has a fourth taper angle, and the fourth taper angle is smaller than the third taper angle. The aneurysm occlusion device according to any one of claims 8 to 11 is characterized in that when the occlusion device is squeezed by radial force, the annular opening (42) is closed. The aneurysm occluding device according to claim 1 is characterized in that the inner side surface (X) of the expanded segment and the outer side surface (Y) of the expanded segment are both arcuate surfaces, both of which are arched toward the distal end, or the inner side surface (X) of the expanded segment is arched toward the proximal end, and the outer side surface (Y) of the expanded segment is arched toward the distal end. The aneurysm occluding device according to claim 1 is characterized in that the occluding device is a single-layer structure, which is obtained by pre-shaping an elastic tube body with non-uniform wall thickness, or the occluding device is a double-layer structure, which is obtained by pre-shaping a double-layer mesh tube. The aneurysm occlusion device according to claim 1 is characterized in that the number of the expansion segments (4) is at least two, and at least two of the expansion segments (4) are vertically spaced apart along the axial direction. The aneurysm occlusion device according to claim 1, characterized in that the outer side surface (Y) of the enlarged segment (4) is partially recessed toward the inner side surface (X) of the enlarged segment, or the inner side surface (X) of the enlarged segment is partially recessed toward the outer side surface (Y) of the enlarged segment to form at least one enlarged segment recessed portion (45), and/or, The outer side surface (B) of the extension section (3) faces the inner side surface (C) of the extension section, or the inner side surface (C) of the extension section (3) is partially recessed toward the outer side surface (B) of the extension section to form at least one extension section recessed portion. A system for occluding an aneurysm, the system comprising: The aneurysm occlusion device according to any one of claims 1 to 16, and A delivery member (6) or a release member corresponding to the aneurysm occlusion device. The system for occluding an aneurysm according to claim 17, wherein the aneurysm is a wide-necked aneurysm at an intracranial bifurcation.