An aneurysm occlusion device and method of making the same

By designing a mesh-woven aneurysm occlusion device, the problems of low metal coverage and large blood flow interference in existing technologies have been solved, achieving efficient aneurysm occlusion and endothelialization, and reducing the risk of aneurysm rupture.

CN112932593BActive Publication Date: 2025-11-21SHANGHAI SUCHANG MEDICAL TECH CO LTD +1
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Patent Information

Application Number
CN202110431320.2
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2021-04-21
Publication Date
2025-11-21
Estimated Expiration
2041-04-21

AI Technical Summary

Technical Problem

Current aneurysm treatment techniques have problems such as low metal coverage, significant interference with blood flow, and slow endothelialization. In particular, stent-assisted coil embolization and covered stent placement have high risks and limitations, while flow diverting devices pose risks of delayed aneurysm rupture and branch vessel occlusion.

Method used

A device for occluding aneurysms is designed, which adopts a mesh braided structure with imaging markers at both ends. The free ends of the braided filaments face inward. Combined with a delivery system, the device is shaped through heat treatment to ensure its fit and smoothness within the aneurysm, reduce interference with blood flow, and promote endothelialization.

Benefits of technology

It improves metal coverage, reduces pressure and interference on aneurysms and blood flow, promotes endothelialization, reduces the risk of aneurysm rupture, and improves embolization effect.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present application relates to the field of medical devices, in particular to an aneurysm occlusion device and a preparation method thereof, the aneurysm occlusion device comprises a mesh woven structure occlusion device body, the both ends of the mesh woven structure are respectively formed with a first bunching part and a second bunching part, the free end of the woven wire bundle of at least one of the first bunching part and the second bunching part is towards the inside of the mesh woven structure, the aneurysm occlusion device is further provided with a distal end imaging mark and a proximal end imaging mark, and the distal end imaging mark and the proximal end imaging mark are respectively arranged in the first bunching part and the second bunching part. The aneurysm occlusion device of the present application has high metal coverage, can effectively reduce the compression of the implanted device to the aneurysm and the interference to the blood flow in the aneurysm cavity, and is beneficial to the rapid endothelialization of cells.
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Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to an aneurysm occlusion device and its preparation method. Background Technology

[0002] Aneurysms are a common vascular disease caused by lesions or damage to the arterial wall, resulting in localized or diffuse dilation or bulging of the arterial wall, primarily manifesting as an expansive, pulsating mass. Aneurysms can occur anywhere in the arterial system. Rupture of an aneurysm can lead to serious consequences, such as subarachnoid hemorrhage caused by intracranial aneurysm rupture, which in severe cases can trigger vasospasm leading to widespread cerebral infarction, resulting in hemiplegia and coma. Currently, the main treatment options for aneurysms are open surgery and endovascular interventional therapy. Open surgery requires opening the body cavity surrounding the aneurysm, such as craniotomy and thoracotomy, causing significant damage to the patient and a long recovery period. Endovascular interventional therapy for aneurysms, with its minimally invasive, safe, and effective advantages, has become the preferred clinical treatment option for many medical experts.

[0003] Currently, the main interventional vascular techniques in clinical practice include stent-assisted coil embolization, covered stent placement, and flow diversion device placement. The treatment principle of stent-assisted coil embolization is to alter the curvature of the parent artery, acting as a "scaffold" for endothelial growth. During this procedure, a microcatheter is used to deliver coils through the stent mesh to fill the aneurysm cavity. Passing the microcatheter through the stent gaps is very difficult, and the procedure carries a high risk of perforation of vascular tissue, resulting in higher costs. Furthermore, there is a risk of recurrence and rupture after aneurysm embolization. Covered stent placement works by isolating blood flow within the aneurysm to induce intra-aneurysmal thrombosis. Covered stents are very difficult to fabricate, and while they can isolate blood flow within the aneurysm, they carry the risk of covering other perforating arteries and obstructing normal blood flow, potentially leading to postoperative stroke complications. Additionally, the use of covered stents limits the flexibility of the delivery system, restricting its ability to traverse tortuous intracranial vessels and limiting its applicability. Flow diversion devices, commonly known as dense mesh stents, primarily utilize changes in blood flow within the parent artery at the neck of an aneurysm to close or significantly reduce blood flow into the aneurysm or arterial dissection, while ensuring the patency of branch vessels. This technique carries risks of delayed aneurysm rupture and occlusion of other small branches, and may also require additional costs and space-occupying effects due to the need for coil packing.

[0004] Intraaneous flow disruption devices are a novel treatment for aneurysms. The principle involves releasing a occlusive device into the aneurysm cavity, altering blood flow at the aneurysm neck and subsequently inducing thrombosis within the aneurysm. This device has minimal impact on the parent artery, eliminates the need for long-term antiplatelet therapy post-operatively, and is applicable regardless of whether the aneurysm has ruptured, thus attracting considerable attention and favor. However, several challenges remain in current technology, such as improving metal coverage, minimizing adverse interference with the aneurysm and blood flow, and achieving rapid endothelialization. Summary of the Invention

[0005] In view of the shortcomings of the prior art described above, the purpose of this invention is to provide an aneurysm occlusion device and its preparation method to solve the problems in the prior art.

[0006] To achieve the above and other related objectives, the present invention provides an aneurysm closure device, comprising a closure device body having a mesh-like braided structure, wherein a first bundle gathering portion and a second bundle gathering portion are respectively formed at both ends of the mesh-like braided structure, wherein the free end of the braided filament bundle of at least one of the first bundle gathering portion and the second bundle gathering portion faces the interior of the mesh-like braided structure, and the aneurysm closure device further comprises a distal imaging marker and a proximal imaging marker, wherein the distal imaging marker and the proximal imaging marker are respectively disposed within the first bundle gathering portion and the second bundle gathering portion.

[0007] The present invention also provides a method for preparing the aneurysm occlusion device, the method comprising the following steps:

[0008] 1) The braided yarns are woven into a mesh structure;

[0009] 2) Gather one end of the mesh structure to form a gathering part, and fix the developing mark on this gathering part;

[0010] 3) Flip the mesh structure inside and out, so that the binding part formed in step 2) is flipped into the inside of the mesh weave structure;

[0011] 4) After placing the mold inside the mesh woven structure, perform heat treatment. After the heat treatment is completed, remove the mold from the structure.

[0012] 5) Gather the other end of the mesh structure to form another gathering part, and fix another developing mark to this gathering part.

[0013] The present invention also provides an aneurysm closure system, the aneurysm closure system including the aneurysm closure device and a delivery system, the delivery system including a delivery guidewire, a delivery sheath, a microcatheter and a release device, the delivery guidewire being disposed inside the delivery sheath, and one end of the delivery guidewire being detachably connected to a proximal imaging marker, and the other end being connected to the release device, the microcatheter being sleeved outside the delivery sheath.

[0014] As described above, the aneurysm occlusion device and its preparation method of the present invention have the following beneficial effects: They have a higher metal coverage, allowing for better fit with the aneurysm cavity, thereby effectively reducing the pressure of the implanted device on the aneurysm and interference with blood flow within the cavity, which is beneficial for rapid endothelialization of cells. The rivetless braided structure reduces impact on the aneurysm top at the distal end and reduces interference with blood flow within the carrier vessel at the proximal end, further improving the clinical efficacy of aneurysm embolization. Simultaneously, the aneurysm occlusion device of this application is a rivetless structure without protrusions, which can accelerate cell endothelialization. Attached Figure Description

[0015] Figure 1 Figure a shows a schematic diagram of the aneurysm closure device of the present invention, figure b shows a schematic diagram of the overall structure of the aneurysm closure system of the present invention, and figure c is a partial enlarged view of the dashed circle in figure b.

[0016] Figure 2 The diagram shows the aneurysm closure device in the aneurysm closure system of the present invention in a compressed state (left) and an expanded state (right).

[0017] Figure 3 Displayed as aneurysm closure devices of different shapes.

[0018] Figure 4 Figure a shows a schematic diagram of an aneurysm occlusion device in the prior art, and figure b shows a schematic diagram of an aneurysm occlusion device after implantation in the body in the prior art.

[0019] Figure 5 The left image shows one of the usage states of the aneurysm closure device of the present invention, and the right image shows one of the usage states of the aneurysm closure device in the prior art.

[0020] Figure 6 The left image shows the aneurysm closure device of the present invention in use at a bifurcation vessel, while the right image shows the aneurysm closure device of the prior art in use at a bifurcation vessel.

[0021] Figure 7 The diagram shows a comparison of the metal coverage area of ​​the aneurysm closure device of the present invention with that of aneurysm closure devices in the prior art.

[0022] Figure 8 The diagram shows the delivery of the aneurysm occlusion system of the present invention.

[0023] Figure 9 The diagram shows the aneurysm closure device of the present invention after it has been fully released.

[0024] Component designation explanation

[0025] 1. Sealing device body

[0026] 11 First Bundle

[0027] 12 Second bundle

[0028] 2. Distant imaging markers

[0029] 3. Proximal imaging markers

[0030] 4. Guide wire

[0031] 5. Delivery sheath

[0032] 6. Microcatheters

[0033] 7. Liberation Device Detailed Implementation

[0034] The following specific embodiments illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification.

[0035] Please see Figures 1 to 9 It should be understood that the structures, proportions, sizes, etc., illustrated in the accompanying drawings are merely for illustrative purposes to aid those skilled in the art and to facilitate understanding and reading. They are not intended to limit the scope of the invention and therefore have no substantial technical significance. Any modifications to the structure, changes in proportions, or adjustments to size, without affecting the effectiveness and purpose of the invention, should still fall within the scope of the technical content disclosed in this invention. Furthermore, the terms such as "upper," "lower," "left," "right," "middle," and "one" used in this specification are merely for clarity and not intended to limit the scope of the invention. Changes or adjustments to their relative relationships, without substantially altering the technical content, should also be considered within the scope of the invention's implementation.

[0036] like Figure 1As shown, the present invention provides an aneurysm closure device, which includes a closure device body 1 with a mesh braided structure. The mesh braided structure has a first bundle gathering portion 11 and a second bundle gathering portion 12 formed at both ends. The free end of the braided filament bundle of at least one of the first bundle gathering portion 11 and the second bundle gathering portion 12 faces the interior of the mesh braided structure. The aneurysm closure device is also provided with a distal imaging mark 2 and a proximal imaging mark 3, which are respectively provided on the first bundle gathering portion 11 and the second bundle gathering portion 12.

[0037] The aneurysm closure device has a compressed state and an inflated state. The compressed aneurysm closure device is as follows: Figure 2 The aneurysm closure device shown in the left image needs to be in a compressed state during implantation to facilitate insertion. The inflated aneurysm closure device is shown below. Figure 2 As shown in the right figure, the aneurysm closure device expands after being implanted into the aneurysm cavity. This expansion can be pre-formed according to the location requiring closure; for example, it can be nearly cylindrical or nearly spherical.

[0038] Near-cylindrical aneurysm closure devices, such as Figure 3 As shown in d. Near-cylindrical refers to a cylinder whose lateral surface transitions to the two rounded corners of its base, replacing the common right-angle transition.

[0039] Near-spherical aneurysm closure devices, such as Figure 3 As shown in a, b, and c. The near-spherical shape is not a perfect sphere; for example, it can be flatter than a perfect sphere. These two shapes of the present invention, by making the sharp portions of the aneurysm closure device surface arc-shaped or curved, can reduce the possibility of bodily injury caused by the aneurysm closure device.

[0040] In one embodiment, the sealing device body 1 comprises 48 to 180 strands of braided filaments.

[0041] The material of the braided filament is selected from shape memory alloys, shape memory metal composites, or shape memory polymers. The shape memory alloy is selected from nickel-titanium alloys, titanium alloys, cobalt-chromium alloys, MP35n, polymers, or 316 stainless steel. The shape memory metal composite is selected from NiTi alloy and noble metal composites, or a combination of NiTi alloys and noble metal developing filaments. Preferably, the shape memory polymer is a high-strength, biodegradable polymer. The polymer is selected from synthetic absorbent monofilaments, G-2 (Glycoprene), or heat-set synthetic absorbent monofilaments. For example, the synthetic absorbent monofilament is poly(lactic-co-lactic-co-l) 90 / 10 (or 90 / 10 lactide / L-lactide). The heat-set synthetic absorbent monofilament is a material that can be heat-set at 110 degrees Celsius for 1 hour, such as lactide (PGA), ε-caprolactone (PCL), trimethylene carbonate (TMC) copolymer, poly(p-dioxanone) (PDO), etc.

[0042] In one embodiment, the braided filaments are coated with a drug or a coating.

[0043] The drugs include those used to promote the achievement of desired biological effects or those capable of promoting the achievement of desired biological processes at target sites. Examples of the former include coagulants or endothelization agents.

[0044] Provided that the coating does not affect the delivery of the aneurysm closure device into the body, the outer surface of the braided filaments may be partially or completely coated to improve the occlusion effect of the aneurysm closure device. The coating may be, for example, polyurethane, silicone rubber, hyaluronic acid, or polyvinylpyrrolidone.

[0045] The occlusion device body 1 has different specifications. After being released by the delivery system, the occlusion device body 1 of different specifications can be matched with the size, shape, and neck width of the lesion tissue and the aneurysm cavity.

[0046] In such Figure 3 In embodiments b and c, the free end of the braided filament bundle of one of the first gathering portion 11 and the second gathering portion 12 faces the inside of the mesh braided structure, while the free end of the braided filament bundle of the other gathering portion faces the outside of the mesh braided structure.

[0047] In such Figure 3 In the two preferred embodiments, a and d, the free ends of the braided filaments at the two binding points of the first binding portion 11 and the second binding portion 12 both face inward toward the mesh braided structure. This aneurysm closure device has no outward-facing structure at the binding portion, resulting in a smoother outer surface that facilitates cell adhesion and growth, and further accelerates the endothelialization process.

[0048] Existing aneurysm closure devices such as Figure 4 As shown in Figure a, the free ends of the braided filaments at the first and second bundled portions of the present invention both face outwards from the mesh braided structure.

[0049] Figure 3 In the aneurysm closure devices in a, b, and d, the free ends of the braided filaments at the first bundle gathering section 11 face inwards towards the inside of the mesh braided structure, relative to the outside of the mesh braided structure. This arrangement ensures that there are no protrusions inside the first bundle gathering section. Figure 5 The left image shows one usage state of the aneurysm closure device of this application, while the right image shows one usage state of a prior art aneurysm closure device. It can be seen that in the usage state, blood flow exerts a certain degree of pressure on the aneurysm closure device. Therefore, if a protrusion exists, blood pressure will push the protruding part to cause a significant impact on the top of the aneurysm. This poses a risk of aneurysm rupture, and the aneurysm closure device itself is prone to fatigue cracks or even breakage. In this embodiment, the first bundle portion 11 is smooth and without protrusions, avoiding stress concentration and making it safer and more reliable.

[0050] Figure 3 In the aneurysm closure devices in a, c, and d, the free ends of the braided wire bundles at the second bundle 12 face inwards towards the inside of the mesh braided structure, compared to facing outwards. This arrangement eliminates protrusions within the second bundle. Protrusions within the second bundle would interfere with blood flow direction to some extent, especially for devices like... Figure 6 As shown in the diagram, the direction of blood flow is multifaceted and complex, and protrusions can cause unpredictable disturbances to the blood flow. For example, when blood flowing parallel to the aneurysm passes through the aneurysm opening, the appearance of the protrusion creates a local obstruction. The long-term flushing and collision between the red blood cells in the blood and the protruding area can cause red blood cell breakage and lead to thrombus formation. At the same time, it can also generate a reaction force on the aneurysm closure device, affecting the fatigue and durability of the aneurysm closure device. Figure 6 The left image shows the aneurysm closure device of this application in use at a bifurcation vessel, while the right image shows the aneurysm closure device in the prior art in use at a bifurcation vessel. On the other hand, the free ends of the braided filaments at the second bundle 12 face the internal structure of the mesh braid, making the interior of the second bundle 12 relatively smoother, which is beneficial for cell adhesion and accelerates the endothelialization process.

[0051] Because the free ends of the braided filaments at the second bundle 12 of the aneurysm closure device face inwards towards the mesh structure, the bottom of the aneurysm closure device is flattened. This ensures that when the aneurysm closure device is connected to the delivery system, the connecting portion is contained within the aneurysm closure device, meaning it does not protrude outside. This structure facilitates a high degree of anastomosis between the bottom of the aneurysm closure device and the carrier vessel, and prevents the connecting portion to the delivery system from falling into the carrier vessel and interfering with blood flow.

[0052] The free ends of the braided filaments in the first bundle gathering section 11 or the second bundle gathering section 12 facing inwards towards the mesh braided structure can also increase the metal coverage area of ​​the aneurysm closure device, such as... Figure 7 As shown, the black-filled area represents the increased metal coverage area compared to existing aneurysm closure devices. The aneurysm closure device fits the aneurysm more closely, reducing blood flow within the aneurysm cavity and promoting blood accumulation and coagulation.

[0053] In one embodiment, the distal imaging marker 2 and the proximal imaging marker 3 are metal rings. The metal rings can be open or closed rings, or C-rings. In one embodiment, the occlusion device body 1 is fixedly connected to the distal imaging marker 2 or the proximal imaging marker 3. In a preferred embodiment, the fixed connection is achieved using biocompatible medical adhesive. In one embodiment, the distal imaging marker 2 and the proximal imaging marker 3 are metal rings, which are fitted onto the braided filament bundle at the binding point. The proximal imaging marker 3 is laser-welded, and the distal imaging marker 2 is bonded with medical adhesive.

[0054] In a preferred embodiment, the positions of the distal imaging mark 2 and the proximal imaging mark 3 depend on the orientation of the free ends of the braided filaments at the first and second bundled portions, respectively. That is, when the free ends of the braided filaments at the bundled portion where the imaging mark is located face the inside of the mesh braided structure, the imaging mark is located inside the sealing device body; when the free ends of the braided filaments at the bundled portion where the imaging mark is located face the outside of the mesh braided structure, the imaging mark is located outside the sealing device body.

[0055] In one embodiment, a protective film is provided on the outer surface of the sealing device body 1. The protective film is a biocompatible material, a material that can be absorbed by the body, or a biomedical material obtained from tissue culture. Such materials may include, for example, polyester fibers, nylon fibers, absorbable biocomposite materials, polyurethane, polyester, polylactic acid, and polyglycolic acid.

[0056] In one embodiment, the protective film is a soft woven fabric.

[0057] In one embodiment, the protective film is bonded to, wrapped around, or sewn onto the sealing device body 1.

[0058] The protective membrane makes the surface of the aneurysm closure device smoother. On the one hand, this reduces friction between the device and internal tissues, minimizing potential damage. On the other hand, it reduces blood flow into the aneurysm sac, causing blood flow stasis and promoting the formation of a stable aneurysm thrombus and endothelialization of the aneurysm neck, thus achieving the goal of treating intracranial aneurysms.

[0059] The present invention also provides a method for preparing the aneurysm occlusion device, the method comprising the following steps:

[0060] 1) The braided yarns are woven into a mesh structure;

[0061] 2) Gather one end of the mesh structure to form a gathering part, and fix the developing mark on this gathering part;

[0062] 3) Flip the mesh structure inside and out, so that the binding part formed in step 2) is flipped into the inside of the mesh weave structure;

[0063] 4) After placing the mold inside the mesh woven structure, perform heat treatment. After the heat treatment is completed, remove the mold from the structure.

[0064] 5) Gather the other end of the mesh structure to form another gathering part, and fix another developing mark to this gathering part.

[0065] In one embodiment, in step 2), a tool is used to gather one end of the mesh structure and insert it into the developing label.

[0066] In one embodiment, the mesh weave structure in step 2) is fixed by welding and developing marking after being gathered together.

[0067] In one embodiment, step 4) involves using a mold and heat treatment to shape the mesh structure within the mold. The mold and heat treatment can also shape the aneurysm occlusion device into different specifications or shapes to match the size, shape, and neck width of the lesion tissue and aneurysm cavity after release from the delivery system.

[0068] In one embodiment, the preparation method further includes processing the free ends of the braided filaments at the gathering portion and the developing marker in step 5) so that they face inward toward the interior of the mesh braided structure. In one embodiment, the processing method involves connecting the developing marker with a tool, applying force to the tool to push the developing marker inward until the developing marker is placed inside the mesh braided structure and the free ends of the braided filaments at the gathering portion face inward toward the interior of the mesh braided structure. The tool may be, for example, a guide wire.

[0069] The present invention also provides an aneurysm closure system, the aneurysm closure system including the aneurysm closure device and a delivery system, the delivery system including a delivery guidewire 4, a delivery sheath 5, a microcatheter 6 and a release device 7, the delivery guidewire 4 being disposed inside the delivery sheath 5, and one end of the delivery guidewire 4 being detachably connected to the proximal imaging marker 3, and the other end being connected to the release device 7, the microcatheter 6 being sleeved outside the delivery sheath 5.

[0070] The aneurysm closure device of the present invention can be separated from the delivery system using existing electro-disengagement or mechanical disengagement methods, thereby allowing the aneurysm closure device to be implanted into the human body. Before complete disengagement, the aneurysm closure device can be retrieved into the delivery sheath, repositioned, and then released. The aneurysm closure system can pass smoothly through the lumen of a microcatheter with a minimum inner diameter of 0.017 inches and be delivered to the aneurysm lesion tissue via this microcatheter. The proximal imaging marker 3 and the delivery guidewire 4 are configured for disengagement at the joint end. Different disengagement methods have different configurations. For example, in electro-disengagement, the disengager 7 is welded to the delivery guidewire 4. Mechanical disengagement can be similar to mechanically disengaging a coil, with a hook at the tip of the delivery guidewire passing through the distal braid of the aneurysm, allowing for immediate disengagement at the target location, which helps shorten the operation time.

[0071] The method of using the aneurysm closure device and aneurysm closure system of the present invention is as follows:

[0072] The aneurysm occlusion device is in a compressed state and placed inside the delivery sheath 5. The microcatheter 6 first reaches the aneurysm lesion, and the delivery sheath 5 carries the aneurysm occlusion device forward within the lumen of the microcatheter 6 until one end reaches the aneurysm opening. Figure 8 As shown, keep the delivery guidewire 4 stationary, retract the delivery sheath 5 to allow the aneurysm occlusion device to detach from the delivery sheath 5 and enter the microcatheter 6, then retract the microcatheter 6, and the aneurysm occlusion device will be slowly released from the microcatheter 6 and eventually be completely released into the aneurysm cavity.

[0073] Before activating the release device 7, the delivery system and the aneurysm occlusion device will not separate. If, during the release of the aneurysm occlusion device to the aneurysm, the imaging markers indicate a need for repositioning or replacement with a different occlusion device, the delivery guidewire 4 can be retracted directly, thus retracting the aneurysm occlusion device back into the delivery sheath 5. The device position can then be readjusted or a suitable aneurysm occlusion device replaced, and the above steps can be repeated. After determining the position or size, the release device 7 connected to the other end of the delivery system is activated, causing the connection point between the delivery system and the aneurysm occlusion device to melt and separate the delivery guidewire 4 and the aneurysm occlusion device. The delivery system is then withdrawn from the patient's body, leaving the aneurysm occlusion device inside the aneurysm for embolization.

[0074] In summary, this invention effectively overcomes the various shortcomings of the prior art and has high industrial application value.

[0075] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in the present invention should still be covered by the claims of the present invention.

Claims

1. An aneurysm occlusion device, characterized in that, The aneurysm occlusion device includes an occlusion device body (1) with a mesh braided structure. The mesh braided structure has a first bundle gathering part (11) and a second bundle gathering part (12) formed at both ends. The free ends of the braided filaments of the first bundle gathering part (11) and the second bundle gathering part (12) face the inside of the mesh braided structure. The bottom of the aneurysm occlusion device is flat. When the aneurysm occlusion device is connected to the delivery system, the connecting part is wrapped inside the aneurysm occlusion device, that is, the connecting part does not protrude outside the aneurysm occlusion device. The bottom of the aneurysm occlusion device is highly matched with the carrier vessel. After the occlusion device body (1) is released by the delivery system, it matches the size, shape and neck width of the lesion tissue and the aneurysm cavity. The aneurysm closure device is further provided with a distal imaging marker (2) and a proximal imaging marker (3), which are respectively located at the first bundle convergence portion (11) and the second bundle convergence portion (12).

2. The aneurysm occlusion device according to claim 1, characterized in that, The sealing device body (1) comprises 48 to 180 strands of braided wire.

3. The aneurysm occlusion device according to claim 1, characterized in that, The material of the braided filament is a shape memory alloy, a shape memory metal composite material, or a shape memory polymer.

4. The aneurysm occlusion device according to claim 1, characterized in that, The braided yarns are coated with a drug or a coating.

5. The aneurysm occlusion device according to claim 1, characterized in that, The sealing device body (1) has different specifications.

6. The aneurysm occlusion device according to claim 1, characterized in that, The distal development mark (2) and the proximal development mark (3) are respectively located on the braided yarn bundles of the first bundle (11) and the second bundle (12).

7. The aneurysm occlusion device according to claim 1, characterized in that, The distal imaging marker (2) and the proximal imaging marker (3) are metal rings.

8. The aneurysm occlusion device according to claim 1, characterized in that, The outer surface of the sealing device body (1) is provided with a protective film.

9. A method for preparing the aneurysm occlusion device according to any one of claims 1-8, characterized in that, The preparation method includes the following steps: 1) The braided yarns are woven into a mesh structure; 2) Gather one end of the mesh structure to form a gathering part, and fix the developing mark on this gathering part; 3) Flip the mesh structure inside and out, so that the binding part formed in step 2) is flipped into the inside of the mesh weave structure; 4) After placing the mold inside the mesh woven structure, perform heat treatment. After the heat treatment is completed, remove the mold from the structure. 5) Gather the other end of the mesh structure to form another gathering part, and fix another developing mark to this gathering part.

10. An aneurysm occlusion system, characterized in that, The aneurysm closure system includes the aneurysm closure device and delivery system according to any one of claims 1-8. The delivery system includes a delivery guidewire (4), a delivery sheath (5), a microcatheter (6), and a release device (7). The delivery guidewire (4) is disposed inside the delivery sheath (5), and one end of the delivery guidewire (4) is detachably connected to the proximal imaging marker (3), and the other end is connected to the release device (7). The microcatheter (6) is sleeved outside the delivery sheath (5).

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