Arterial aneurysm embolization device

Abstract

The invention relates to an aneurysm embolism device, which comprises an embolism main body, which comprises a near-side net body, a middle net body and a far-side net body which are sequentially connected along the axial direction of the embolism main body, and the diameter of the middle net body is smaller than the diameter of the near-side net body and the diameter of the far-side net body; the aneurysm embolism device has a compressed state and an unfolded state, in the compressed state, the near-side net body and the far-side net body are oppositely folded, the near-side net body is folded and wraps the middle net body, and the far-side net body is folded and wraps the near-side net body; therefore, the pushing resistance of the device in the conveying catheter can be reduced, and the operation difficulty is reduced.

Description

Technical Field

[0001] The invention belongs to the field of medical devices, and in particular relates to an aneurysm embolization device. Background Art

[0002] Cerebrovascular disease (CVD) is a type of disease that occurs in the brain blood vessels and causes brain tissue damage due to impaired intracranial blood circulation. Clinically, acute onset is the most common, and most patients are middle-aged or elderly, with symptoms such as hemiplegia and speech disorders. Acute cerebrovascular disease is generally divided into two categories: ischemic and hemorrhagic. Among them, hemorrhagic cerebrovascular disease is mainly caused by aneurysm rupture. Intracranial aneurysms (IAN) are mostly pathological protrusions that occur on the walls of intracranial arteries and are the leading cause of subarachnoid hemorrhage. The cause of intracranial aneurysms is still unclear. Most scholars believe that intracranial aneurysms are caused by local congenital defects in the walls of intracranial arteries and increased intracavitary pressure. Hypertension, cerebral arteriosclerosis, and vasculitis are related to the occurrence and development of aneurysms. Subarachnoid hemorrhage caused by aneurysm rupture has a high mortality and disability rate; studies have shown that the mortality rate of the first bleeding due to intracranial aneurysm rupture is about 15% to 20%, and the mortality rate within 2 years without timely diagnosis and treatment is as high as 75% to 85%; and once the aneurysm ruptures, more than 1 / 3 of patients will still be unable to complete a normal life.

[0003] The existing methods for treating intracranial aneurysms are mainly divided into two categories: craniotomy and clipping surgery and neurointerventional surgery. Among them, craniotomy and clipping surgery has the disadvantages of large trauma, long recovery time, and many complications. Therefore, with the development and iteration of various medical devices in the field of neurointervention, minimally invasive interventional surgery in the tumor has emerged with clinical effects such as small trauma, safety, effectiveness, and significantly shortened treatment time. The main methods of neurointerventional surgery for treating aneurysms include coil embolization, covered stent occlusion, and dense mesh stent blood flow guidance. Among them, coil embolization has the limitation of requiring multiple delivery of product interventional treatment, each delivery may cause damage to the patient and prolong the operation time, the surgeon and the patient receive more radiation, and the coil embolization is also prone to space-occupying effect, and it is easy to herniate aneurysms; the covered stent is hard and difficult to pass through tortuous blood vessels; and the dense mesh stent is particularly difficult to operate in the treatment of bifurcated aneurysms, and both are prone to cause stenosis in the tumor-bearing artery, causing ischemic complications. Therefore, the existing interventional treatment methods have limitations in treating aneurysms to a certain extent.

[0004] It should be noted that the information disclosed in the background technology section of this application is only intended to deepen the understanding of the general background technology of this application, and should not be regarded as an admission or suggestion in any form that the information constitutes prior art already known to those skilled in the art. Summary of the invention

[0005] The purpose of the present invention is to provide an aneurysm embolization device, which can effectively reduce the pushing resistance of the device in a delivery catheter and reduce the difficulty of surgery.

[0006] To achieve the above object, the present invention provides an aneurysm embolization device, comprising:

[0007] The embolization body comprises a proximal mesh body, an intermediate mesh body and a distal mesh body which are sequentially connected along its own axis, wherein the diameter of the intermediate mesh body is smaller than the diameter of the proximal mesh body and the diameter of the distal mesh body;

[0008] The aneurysm embolization device has a compressed state and an expanded state. In the compressed state, the proximal mesh and the distal mesh are folded toward each other, and the proximal mesh is folded and wrapped around the middle mesh, and the distal mesh is folded and wrapped around the proximal mesh.

[0009] Optionally, in the compressed state, the distal mesh and the proximal mesh partially overlap in the axial direction.

[0010] Optionally, in the compressed state, the length of the overlapping portion of the proximal mesh and the distal mesh is 1 / 3 to 2 / 3 of the total length of the proximal mesh in the compressed state.

[0011] Optionally, the length of the overlapping portion of the proximal mesh and the distal mesh is 1.0 mm to 1.5 mm.

[0012] Optionally, it also includes:

[0013] A microciliary structure is made of biodegradable material, and a plurality of the microciliary structures are attached to the surface of the embolic body and are located between the proximal mesh body and the distal mesh body.

[0014] Optionally, the microciliary structure is formed by attaching it to the surface of the embolic body through an electrospinning process.

[0015] Optionally, the coverage rate of the microciliary structure is 15% to 25%.

[0016] Optionally, the proximal mesh and the distal mesh are both of double-layer configuration, wherein the microciliary structure is provided on at least one of the distal surface of the proximal mesh, the proximal surface of the distal mesh and the surface of the intermediate mesh.

[0017] Optionally, the length of the microciliary structure is configured to extend to the outside of the embolic body without passing through the mesh when the aneurysm embolization device is in a compressed state.

[0018] Optionally, the embolic body can be fully visualized, and / or, in the expanded state, the proximal mesh and the distal mesh are both umbrella-shaped, and there is no overlapping portion between the proximal mesh and the distal mesh.

[0019] As described above, in the aneurysm embolization device provided by the present invention, the embolization body can completely cover the aneurysm neck at one time through the proximal mesh body, and fill the aneurysm cavity through the distal mesh body, thereby blocking blood from entering the aneurysm, and disturbing the flow in the aneurysm to cause embolism, and finally achieving stable, dense and complete embolism. Moreover, in the compressed state of the aneurysm embolization device, the proximal mesh body and the distal mesh body are folded toward each other, and the proximal mesh body is folded and wrapped on the middle mesh body, and the distal mesh body is folded and wrapped on the proximal mesh body. In this way, the large push resistance caused by the folding and contraction of the proximal mesh body can be avoided, thereby reducing the push resistance of the device in the delivery catheter and reducing the difficulty of the operation.

[0020] The aneurysm embolization device provided by the present invention can further be provided with a microciliary structure on the surface of the embolization body, and the microciliary structure is biodegradable. In this way, the microciliary structure can activate the intratumoral cells involved in tissue repair, enhance tissue reaction and coagulation activity, induce fibroblasts and tissue cells to climb on the dense network (i.e., the embolization body), and promote the activity of tissue reaction, thereby achieving rapid and stable thrombosis and achieving better embolization effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0022] Figure 1 is a front view of an aneurysm embolization device according to an embodiment of the present invention;

[0023] Figure 2 is an oblique view of an aneurysm embolization device according to an embodiment of the present invention;

[0024] Figure 3 is a schematic diagram of a compressed state of the aneurysm embolization device according to an embodiment of the present invention during delivery;

[0025] Figure 4 is a schematic diagram of a compressed state of the aneurysm embolization device according to an embodiment of the present invention when being delivered in a delivery catheter;

[0026] Figure 5 Schematic diagram of the aneurysm embolization device according to an embodiment of the present invention in the expanded state when filling an aneurysm.

[0027] The following are the descriptions of the reference numerals:

[0028] 100-aneurysm embolization device; 110-embolization body; 111-proximal mesh; 1111-distal mesh surface of proximal mesh; 1112-proximal mesh surface of proximal mesh; 1113-outer edge of proximal mesh; 112-middle mesh; 113-distal mesh; 1131-proximal mesh surface of distal mesh; 1132-distal mesh surface of distal mesh; 1133-outer edge of distal mesh; 120-microciliary structure; 10-aneurysm; 11-aneurysm neck; 12-aneurysm top; 20-push rod; 30-delivery catheter. DETAILED DESCRIPTION

[0029] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0030] As used in the present invention, the singular forms "a", "an" and "the" include plural objects, the term "or" is generally used in a sense including "and / or", the term "several" is generally used in a sense including "at least one", and the term "at least two" is generally used in a sense including "two or more". In addition, the terms "proximal end" and "proximal side" generally refer to the end close to the operator of the medical device, the terms "distal end" and "distal side" generally refer to the end away from the operator of the medical device, "one end" and "the other end" as well as "proximal end" and "distal end" generally refer to two corresponding parts, which not only include endpoints. 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 integrated connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. In addition, as used in the present invention, an element disposed on another element generally only indicates that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the connection, coupling, cooperation or transmission between the two elements may be direct or indirect through an intermediate element, and cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, one element may be in any orientation such as inside, outside, above, below or on one side of another element, unless otherwise clearly indicated in the content. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0031] The "diameter" mentioned in this application document refers to the maximum outer diameter, that is, the distance between two points that are farthest apart at any position in the direction perpendicular to the central axis is the maximum diameter. The "axial direction" mentioned herein refers to the central axis direction, and the "axial direction" corresponds to the direction from the neck of the aneurysm to the top of the aneurysm when the aneurysm embolization device is used to fill the aneurysm.

[0032] The core idea of ​​the present invention is to provide an aneurysm embolization device that can effectively reduce the push resistance of the device in the delivery catheter and reduce the difficulty of surgery. The aneurysm embolization device includes but is not limited to the treatment of intracranial aneurysms, and can also be used to treat aneurysms in other vascular locations.

[0033] The following description is given with reference to the accompanying drawings.

[0034] refer to Figure 1 to Figure 5 The present invention provides an aneurysm embolization device 100, which includes an embolization body 110 constructed of a braided fabric. The embolization body 110 includes a proximal mesh 111, an intermediate mesh 112, and a distal mesh 113 connected in sequence along its own axis. The shapes of the proximal mesh 111 and the distal mesh 113 after being unfolded are adapted to the shape of the aneurysm wall and can adapt to the aneurysm wall. Preferably, the proximal mesh 111 and the distal mesh 113 are umbrella-shaped after being unfolded. The umbrella-shaped proximal mesh 111 and the distal mesh 113 have a small push resistance during the delivery process, and are not easy to squeeze each other after being opened in the aneurysm 10, and are not easy to cause damage to the aneurysm 10. The umbrella-shaped setting also enables the aneurysm embolization device 100 to fit the inner wall of the aneurysm cavity to the greatest extent, which can effectively reduce the risk of displacement of the aneurysm embolization device 100 after being implanted into the aneurysm cavity. Preferably, the proximal mesh 111 and the distal mesh 113 are both double-layer configurations. The double-layer configuration refers to the presence of two layers of mesh. Both the proximal mesh 111 and the distal mesh 113 are double-layer configurations, which is conducive to the attachment of the microciliary structure 120 inside the embolic body 110. The middle mesh 112 is a columnar hollow structure, which is convenient for the attachment of the microciliary structure 120 and ensures effective force conduction performance during the delivery process. The diameter of the middle mesh 112 is smaller than the diameter of the proximal mesh 111 and the diameter of the distal mesh 113. The diameter here refers to the outer diameter, that is, the outer diameter in the unfolded state.

[0035] Reference Figure 5, which is a scene of the aneurysm embolization device 100 of the present invention being deployed in an aneurysm 10, wherein the aneurysm 10 has an aneurysm neck 11 and an aneurysm top 12 arranged opposite to each other. It can be seen that the deployed proximal mesh 111 and the distal mesh 113 both conform to the shape of the aneurysm 10, and the diameter of the proximal mesh 111 is greater than the diameter of the aneurysm neck 11, so that the proximal mesh 111 can fully cover the aneurysm neck 11 at one time after deployment. It can also be seen that when filling the tumor, the proximal mesh 111 is filled in the lower half of the tumor cavity (not just limited to 1 / 2 of the tumor cavity), and the proximal mesh 111 covers the tumor neck 11 while also fitting the tumor wall, while the distal mesh 113 is filled in the upper half of the tumor cavity and fits the tumor wall in the shape of the tumor top 12. At the same time, the middle mesh 112 connects the proximal mesh 111 and the distal mesh 113, and the proximal mesh 111 can further support the distal mesh 113 through the middle mesh 112, ultimately achieving stable occlusion of the aneurysm embolization device, which is not prone to displacement.

[0036] It should also be recognized that the deployed distal mesh 113 is placed near the dome 12 of the aneurysm 10, and the distal mesh 113 is allowed to conform to the shape of the dome 12 in a manner that does not damage the dome 12, which can avoid impacting the dome 12 and reduce the risk of rupture of the aneurysm 10. This also allows the distal mesh 113 to act as an anchor and fix itself in the aneurysm 10 without conforming to the entire shape of the aneurysm 10. Because the aneurysm embolization device 100 only needs to be fixed in the aneurysm 10 by making the deployed distal mesh 113 conform to the dome 12, the aneurysm embolization device 100 can be applied to a variety of shapes and sizes of aneurysms 10, expanding the scope of application.

[0037] In practice, when the aneurysm embolization device 100 is filling the aneurysm, the distal mesh 113 is first opened and fills the aneurysm cavity, and then the proximal mesh 111 is opened. While opening, the proximal mesh 111 supports the distal mesh 113 from below to promote the opening of the distal mesh 113. After the proximal mesh 111 is opened, the aneurysm neck 11 is completely blocked at one time. At the same time, preferably, the microciliary structure 120 promotes cell attachment within the tumor to accelerate the stabilization of the thrombosed aneurysm cavity and promote the healing of the aneurysm 10.

[0038] The embolization body 110 is mainly made of a relatively dense braid. In this way, the proximal mesh 111 can tightly cover the aneurysm neck 11, and can support the distal mesh 113, maintain the stability of the entire device, so that the entire aneurysm embolization device 100 can be stably maintained in the aneurysm 10 and is not easily removed from the aneurysm 10. The proximal mesh 111, the distal mesh 113 and the intermediate mesh 112 are an integral braided structure or are independently braided and connected. Alternatively, the distal mesh 113 is integrally braided with the intermediate mesh 112, and then connected to the proximal mesh 111, or the proximal mesh 111 is integrally braided with the intermediate mesh 112, and then connected to the distal mesh 113.

[0039] like Figure 3 and Figure 4 As shown, the aneurysm embolization device 100 of the present invention is delivered to the aneurysm 10 via a delivery catheter 30 (such as a microcatheter, etc.). The delivery catheter 30 delivers the aneurysm embolization device 100 to the aneurysm 10, and during the delivery process, the aneurysm embolization device 100 is kept in a compressed state. Specifically, the aneurysm embolization device 100 is assisted by a push rod 20, and the aneurysm embolization device 100 is pushed through the delivery catheter 30 by the push rod 20 and leaves the delivery catheter 30, and is completely delivered to the aneurysm 10. The push rod 20 is detachably connected to the proximal end of the aneurysm embolization device 100, and the manner of detachable connection is not limited, for example, mechanical detachment, electrolytic detachment, chemical detachment, etc. that can be understood by those skilled in the art can be adopted.

[0040] In practice, the aneurysm embolization device 100 of the present invention has at least a compressed state and an expanded state, wherein the expanded state includes a natural expanded state when there is no external force constraint and a constrained expanded state when filling the aneurysm 10. The aneurysm embolization device 100 is in a compressed state in the delivery catheter 30, and returns to the expanded state after being released from the delivery catheter 30. Figure 1 and Figure 2 4 shows the naturally expanded state of the aneurysm embolization device 100 .

[0041] In particular, when the aneurysm embolization device 100 is pressed and gripped into the delivery catheter 30, the proximal mesh 111 and the distal mesh 113 are folded toward each other, and the proximal mesh 111 is first folded and wrapped on the middle mesh 112, and then the distal mesh 113 is folded and wrapped on the proximal mesh 111. In this way, the large push resistance caused by the folding and contraction of the proximal mesh 111 can be avoided, thereby reducing the push resistance of the device in the delivery catheter 30 and reducing the difficulty of the operation. The proximal mesh 111 and the distal mesh 113 are folded toward each other, which means that the proximal mesh 111 and the distal mesh 113 are both folded toward each other.

[0042] It can be understood that the folding direction of the proximal mesh body 111 is Figure 4The direction indicated by the arrow A1 is that the proximal mesh 111 turns from the proximal end to the distal end and folds inwardly, while the folding direction of the distal mesh 113 is the direction indicated by the arrow B1, that is, the distal mesh 113 turns from the distal end to the proximal end and folds inwardly to cover the proximal mesh 111. If the distal mesh 113 does not cover the proximal mesh 111, then when the proximal mesh 111 is folded in the delivery catheter 30, the edge is just facing the pushing direction of the device (pushing from the proximal end to the distal end), which will hinder the pushing of the device and increase the pushing resistance. Therefore, Figure 3 and Figure 4 Such a compressed structure can avoid the large push resistance caused by the folding and contraction of the proximal mesh 111. Of course, in the unfolded state, there is no overlapping part between the proximal mesh 111 and the distal mesh 113, and the two can be opened without interfering with each other. In practice, by adjusting the axial distance between the proximal mesh 111 and the distal mesh 113 or the axial height of the middle mesh 112, it is ensured that the distal mesh 113 can cover the proximal mesh 111 in the compressed state.

[0043] Further preferably, in the compressed state, the distal mesh 113 partially overlaps with the proximal mesh 111 in the axial direction, that is, only a portion of the proximal mesh 111 is covered by the distal mesh 113, and the distal mesh 113 does not cover the entire proximal mesh 111; in this way, the push resistance can be better reduced, and the proximal mesh 111 is not easy to escape from the distal mesh 113, thereby ensuring the covering effect. Preferably, in the compressed state, the length L of the overlapping portion of the proximal mesh 111 and the distal mesh 113 is 1 / 3 to 2 / 3 of the total length of the proximal mesh 111 in the compressed state, for example, 1 / 3, 1 / 2 or 2 / 3. Optionally, the length L of the overlapping portion of the proximal mesh 111 and the distal mesh 113 is 1.0 mm to 1.5 mm.

[0044] As mentioned above, the proximal mesh 111 and the distal mesh 113 are preferably double-layered after being unfolded. Figure 1 and Figure 2Specifically, the proximal mesh 111 has a distal surface 1111 adjacent to the distal mesh 113 and a proximal surface 1112 spaced apart from and opposite to the distal surface 1111, and the distal mesh 113 has a proximal surface 1131 adjacent to the proximal mesh 111 and a distal surface 1132 spaced apart from and opposite to the proximal surface 1131. The distal surface 1111 of the proximal mesh 111 can be curved inward (i.e., toward the proximal end) or can be substantially flat, so as to adapt in shape to the aneurysm 10 to be blocked. The proximal surface 1131 of the distal mesh 113 can also be curved inward (i.e., toward the distal end) or can be substantially flat, so as to adapt in shape to the aneurysm 10 to be blocked. The proximal surface 1112 of the proximal mesh 111 is arranged across the tumor neck 11, and the proximal surface 1112 of the proximal mesh 111 can elastically press the outer edge 1113 (i.e., the edge) and firmly press it against the tumor wall. The distal mesh surface 1132 of the distal mesh 113 is attached to the tumor top 12 in a non-damaging manner and conforms to the shape of the tumor top 12. Similarly, the distal mesh surface 1132 of the distal mesh 113 can elastically press its outer edge 1133 (i.e., the edge) and firmly press it against the tumor wall. It should also be noted that non-damaging means that the mesh surface is smooth and flat, and basically has no sharp points or protrusions.

[0045] The manufacturing method of the embolic body 110 is not limited. In a preferred method, first, a tubular braid is formed by weaving a plurality of silk threads, and then the tubular braid is shaped into the embolic body 110. Optionally, the tubular braid can be radiopaque. For example, radiopaque silk threads, such as platinum or gold or other radiopaque materials are woven into the tubular braid, or the tubular braid is plated or coated with a radiopaque material, or a radiopaque marker is added to the tubular braid. Preferably, the silk threads used for weaving are made of shape memory alloys, which can be of any type, but preferably DFT materials (i.e., composite core wires) are used. DFT materials have good superelasticity and developability, and can maintain good compliance in tortuous blood vessels. The embolic body 110 is preferably able to be developed throughout.

[0046] Return to reference Figure 1 and Figure 2The aneurysm embolization device 100 preferably also includes a plurality of microciliary structures 120 attached to the surface of the embolization body 110. The microciliary structures 120 are mainly attached to the inside of the embolization body 110 and are not exposed to the outside of the embolization body 110. When the microciliary structures 120 are arranged, on the one hand, it is avoided that the microciliary structures 120 may bring about a large push resistance, and on the other hand, it is avoided that the microciliary structures 120 fall off during the delivery process. The inside of the embolization body 110 should be understood as that the microciliary structures 120 are only arranged in the area between the proximal mesh 111 and the distal mesh 113, such as the distal surface 1111 of the proximal mesh 111, the proximal surface 1131 of the distal mesh 113, and the surface of the intermediate mesh 112, and these surfaces will not contact the inner wall of the delivery catheter, nor will they contact the aneurysm wall. However, it should be recognized that at least one of the distal surface 1111 of the proximal mesh 111, the proximal surface 1131 of the distal mesh 113, and the surface of the intermediate mesh 112 is provided with the microciliary structure 120. In this embodiment, the microciliary structure 120 is mainly attached to the distal surface 1111 of the proximal mesh 111, the proximal surface 1131 of the distal mesh 113, and the surface of the intermediate mesh 112.

[0047] The microciliary structure 120 is a thin and long polymer filament extending outward from the dense mesh surface on the embolic body 110, which is visible under a light microscope. Preferably, the diameter of the microciliary structure 120 is 0.00010 inch to 0.00012 inch. The microciliary structure 120 is made of a biodegradable material. The biodegradable material for preparing the microciliary structure 120 is a commonly used material in the art, such as polyglycolic acid (PGA), polylactic acid (PLA), polylactic acid-glycolic acid copolymer (PLGA), poly(glycolide) (PGLA), left-handed polylactic acid (PLLA), right-handed polylactic acid (PDLA), racemic polylactic acid (PDLLA), etc., and this application is not limited to this. In this way, after the tumor neck 11 completes endothelialization, the microciliary structure 120 can be biodegraded to reduce the risk of complications.

[0048] The microciliary structure 120 is equivalent to microciliary tissue, which can activate cells involved in human tissue repair, enhance human tissue response and coagulation activity, induce fibroblasts and tissue cells to climb on the dense network, promote the activity of human tissue response, and ultimately achieve rapid, stable thrombosis and complete embolism. Therefore, the microciliary structure 120 can effectively induce cell climbing, promote rapid and stable thrombosis in the tumor cavity, and while ensuring better force conduction, it will not affect the push resistance of its delivery process. The material of the microciliary structure 120 is soft, not easy to cause damage to the delivery system and blood vessels, and has excellent biocompatibility. It can be biodegraded after endothelialization in the tumor, reducing harm to the human body.

[0049] In practice, the microciliary structure 120 can be directly attached to the surface of the plug body 110 by an electrospinning process, or the raw material for preparing the microciliary structure 120 can be manually fixed on the plug body 110. In this embodiment, the microciliary structure 120 can be prepared by spinning directly on the surface of the shaped plug body 110 by an electrospinning machine, so that the preparation process is relatively simple, which can reduce the production cost and simplify the production process.

[0050] Preferably, the coverage rate of the microciliary structure 120 is 15% to 25%, that is, the coverage area of ​​the microciliary structure 120 accounts for 15% to 25% of the surface area of ​​the entire plug body 110. In this way, sufficient microciliary structures 120 are ensured without affecting the pushing performance of the device.

[0051] Considering that when the length of the microciliary structure 120 is too long, it is easy to herniate through the mesh of the embolization body 110 to the outside of the embolization body 110, resulting in excessive push resistance, therefore, the microciliary structure 120 should not be set too long. The length of the microciliary structure 120 refers to the length of the microciliary structure 120 after being completely straightened. Preferably, the length of the microciliary structure 120 is configured so that it does not protrude through the mesh to the outside of the embolization body 110 when the aneurysm embolization device 100 is in a compressed state.

[0052] The size of the microciliary structure 120 should also match the endothelialization process of the tumor neck as much as possible, and is usually determined by the length of the microciliary structure 120. The length of the microciliary structure 120 should ensure that the microciliary structure 120 is degraded at the same time or a little later than the completion of the endothelialization of the tumor neck. The microciliary structure 120 should not be degraded before the endothelialization of the tumor neck is completed.

[0053] In some embodiments, the length of the microciliary structure 120 can be set with reference to the dimensions in Table 1. Table 1: Length of the microciliary structure 120 under different models and specifications:

[0054] Model Specifications Length of microciliary structure (unit, mm) Specification 1 0.5～1.5 Specification 2 1.0～2.0 Specification 3 2.0～3.0 Specification 4 3.0～4.0 Specification 5 3.5～5.0

[0055] It should be noted that the length of the microciliary structure 120 is not limited to the sizes listed in Table 1.

[0056] Preferably, the mesh of the proximal mesh 111 is denser and has better blocking properties. Preferably, the number of braiding heads of the proximal mesh 111 is 48 to 192. Preferably, the wire diameter of the braided wire of the proximal mesh 111 is 0.015 mm to 0.035 mm. Preferably, the proximal mesh 111 is formed by weaving DFT metal wire. Preferably, the pushability of the distal mesh 113 is better, and its mesh can be slightly sparse. In this way, the number of braiding heads of the distal mesh 113 is small, which is not only conducive to cell climbing, but also reduces the push resistance. Preferably, the number of braiding heads of the distal mesh 113 is 48 to 96. Preferably, the wire diameter of the braided wire of the distal mesh 113 is 0.020 mm to 0.040 mm. Preferably, the distal mesh 113 is formed by weaving DFT metal wire.

[0057] Preferably, the height of the distal mesh 113 is relatively large and the diameter is relatively small, and the proximal mesh 111 is relatively short and the diameter is relatively large. The specific size ratio is shown in Table 2. Preferably, H1:H2 is 2:1, and D1 is 1-2 mm smaller than D2. When the distal mesh 113 is high, it can ensure that the microciliary structure 120 has sufficient contact area with the cells in the tumor, which makes it easier to promote the climbing of the cells in the tumor. At the same time, the small diameter of the distal mesh 113 can adapt to various types of aneurysms 10. When the proximal mesh 111 is short, it can ensure that the device is stably opened and has a double-layer blocking effect on the blood flow. At the same time, the large diameter of the proximal mesh 111 can ensure the anchoring of the device and prevent the device from shifting.

[0058] In some embodiments, the diameter and height of the proximal mesh 111 and the distal mesh 113 can be set with reference to the dimensions in Table 2. In the unfolded state, the height of the distal mesh 113 is H1, the diameter of the distal mesh 113 is D1, the height of the proximal mesh 111 is H2, and the diameter of the proximal mesh 111 is D2. Table 2: Height and diameter of the proximal mesh 111 and the distal mesh 113 under different models and specifications:

[0059]

[0060]

[0061] It should be noted that the sizes of the proximal mesh 111 and the distal mesh 113 are not limited to the sizes listed in Table 2. In practice, those skilled in the art may set them according to the size of the aneurysm 10 to be filled.

[0062] In addition, the length of the microciliary structure 120 can be adjusted according to the size of the proximal mesh 111 and the distal mesh 113. The larger the diameter and height of the proximal mesh 111 and the distal mesh 113, the longer the length of the microciliary structure 120 can be, which is conducive to promoting intratumor cell climbing. For example, in conjunction with Table 1 and Table 2, it can be understood that the size of the proximal mesh 111 and the distal mesh 113 under the same specifications matches the length of the microciliary structure 120 under the same specifications.

[0063] In summary, the aneurysm embolization device provided by the present invention adopts two dense mesh structures as a whole (i.e., the distal mesh and the proximal mesh). In actual use, the proximal mesh acts on the neck of the tumor to block the neck of the tumor once and for all, thereby blocking the blood flow into the tumor, while the distal mesh acts on the part inside the tumor to form an intratumoral embolism, thereby promoting the healing of the aneurysm. At the same time, the two dense mesh structures cooperate with each other to further constrain the positions of the two parts, reduce the displacement of the device, and prevent the device from herniating the aneurysm. The stability and support are good. In particular, during the delivery process, the distal mesh can also cover the proximal mesh, effectively reducing the push resistance. At the same time, after the delivery system is pushed out, the proximal mesh can provide support for the distal mesh to assist the distal mesh in opening.

[0064] In addition, the degradable microciliary structure attached to the embolic body can activate cells involved in human tissue repair, enhance human tissue response and coagulation activity, induce fibroblasts and tissue cells to climb on the dense network, and promote the activity of tissue response, thereby promoting stable embolism within the tumor. After endothelialization, it can be biodegraded to reduce the risk of complications.

[0065] In general, the aneurysm embolization device provided by the present invention can be used for intra-tumor embolization, effectively preventing aneurysm rupture, increasing embolization volume, and promoting aneurysm healing. In addition, for ruptured aneurysms, it can also effectively block blood flow from herniating into the tumor-bearing artery. Moreover, the device is easy to operate and can achieve a one-time occlusion effect, thereby reducing the risk of multiple product delivery causing damage to the patient, reducing operation time, and reducing the harm of radiation to the operator and the patient.

[0066] It should also be noted that, as discussed herein, a "patient" or "individual" can be a human or any animal. It should be understood that the animal can be of any suitable type, including but not limited to mammals, veterinary animals, livestock animals, or pet animals. For example, the animal can be a laboratory animal specifically selected to have certain characteristics similar to humans, such as mice, dogs, pigs, etc.

[0067] The above description is only a description of the preferred embodiment of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the scope of protection of the technical solution of the present invention.

Claims

1. An aneurysm embolization device, characterized in that: include: The embolization body comprises a proximal mesh body, an intermediate mesh body and a distal mesh body which are sequentially connected along its own axis, wherein the diameter of the intermediate mesh body is smaller than the diameter of the proximal mesh body and the diameter of the distal mesh body; The aneurysm embolization device has a compressed state and an expanded state. In the compressed state, the proximal mesh and the distal mesh are folded toward each other, and the proximal mesh is folded and wrapped around the middle mesh, and the distal mesh is folded and wrapped around the proximal mesh.

2. The aneurysm embolization device according to claim 1, characterized in that: In the compressed state, the distal mesh and the proximal mesh partially overlap in the axial direction.

3. The aneurysm embolization device according to claim 2, characterized in that: In the compressed state, the length of the overlapping portion of the proximal mesh and the distal mesh is 1 / 3 to 2 / 3 of the total length of the proximal mesh in the compressed state.

4. The aneurysm embolization device according to claim 3, characterized in that: The length of the overlapping portion of the proximal mesh and the distal mesh is 1.0 mm to 1.5 mm.

5. The aneurysm embolization device according to claim 1, characterized in that: Also includes: A microciliary structure is made of biodegradable material, and a plurality of the microciliary structures are attached to the surface of the embolic body and are located between the proximal mesh body and the distal mesh body.

6. The aneurysm embolization device according to claim 5, characterized in that: The microciliary structure is formed by attaching to the surface of the embolic body through an electrostatic spinning process.

7. The aneurysm embolization device according to claim 5, characterized in that: The coverage rate of the microciliary structure is 15% to 25%.

8. The aneurysm embolization device according to claim 5, characterized in that: The proximal mesh and the distal mesh are both of double-layer configuration, wherein the microciliary structure is provided on at least one of the distal surface of the proximal mesh, the proximal surface of the distal mesh, and the surface of the intermediate mesh.

9. The aneurysm embolization device according to claim 5, characterized in that: The length of the microciliary structure is configured to extend to the outside of the embolic body without passing through the mesh when the aneurysm embolization device is in a compressed state.

10. The aneurysm embolization device according to claim 1, characterized in that: The embolic body can be fully visualized, and / or, in the expanded state, the proximal mesh and the distal mesh are both umbrella-shaped, and there is no overlapping part between the proximal mesh and the distal mesh.

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