Aneurysm occlusion device, aneurysm occlusion treatment device and aneurysm occlusion system

Abstract

The present application relates to a kind of hemangioma occlusion device, hemangioma occlusion treatment device and hemangioma occlusion system;Hemangioma occlusion system includes hemangioma occlusion device and microcatheter;Hemangioma occlusion device includes the main occlusion structure of net tubular shape, main occlusion structure has the unwinding state of plane helix and is used for from inside the vessel delivery to aneurysm compressed state, and the net tube outer diameter of main occlusion structure is uneven, so that the outer diameter distribution of plane helix when main occlusion structure unwinds is uneven;Hemangioma occlusion device is compressed in microcatheter, and after being separated from microcatheter, it can also restore into unwinding state;Hemangioma occlusion treatment device includes hemangioma occlusion device and push rod, push rod is connected to the proximal end of main occlusion structure.The present application is suitable for irregular aneurysm, and the forming effect is good, and it is easier to realize the occlusion of tumor neck.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a vascular tumor occlusion device, a vascular tumor occlusion treatment device and a vascular tumor occlusion system. BACKGROUND

[0002] An intracranial aneurysm is a pathological protrusion of the intracranial artery wall, with an incidence of 5% to 10%. MRA studies show that the incidence of unruptured aneurysms in Chinese adults aged 35 to 75 is about 7.0%. Although subarachnoid hemorrhage caused by the rupture of an intracranial aneurysm accounts for about 5% of cerebral apoplexy, the mortality rate of the first rupture is 20% to 30%, and the mortality rate of the second rupture is as high as 60%. The fundamental treatment for an aneurysm is to completely isolate the aneurysm from the blood circulation through treatment means. Current treatment methods mainly include craniotomy clipping treatment and endovascular interventional treatment. Among them, the endovascular interventional treatment method can avoid the brain tissue and directly reach the lesion, and the minimally invasive characteristics make it the mainstream of the current treatment of intracranial aneurysms. Current endovascular interventional treatment mainly includes the following:

[0003] (1) The aneurysm coil embolization is the main method for treating aneurysms at present, and its treatment principle is to change the local hemodynamic factors, promote thrombosis, and then achieve the occlusion and treatment of aneurysms. However, the shape of an aneurysm varies, and incomplete coil filling can lead to aneurysm recanalization, and excessive filling may lead to intraoperative rupture of the aneurysm, requiring high skills and experience of the doctor. Moreover, coil filling needs to be repeated multiple times, and the embolization efficiency is low, and in some cases, a stent, a balloon and a microcatheter are needed for assistance, and the operation is complex. Moreover, for wide-diameter aneurysms, the coil is easy to herniate into the parent artery, affecting blood flow, and in severe cases, it may also cause vascular stenosis.

[0004] (2) The flow diversion device is a major breakthrough in the endovascular treatment of intracranial aneurysms, and brings a new method for the treatment of complex aneurysms. Its treatment principle is to place a dense mesh stent in the parent artery, and after the lumen of the diseased blood vessel is reconstructed, the luminal surface is reshaped through the neointima of the aneurysm neck surface. The application of the flow diversion device significantly improves the long-term efficacy of large and giant aneurysms, and significantly reduces the use of coils. According to the computer hemodynamic simulation analysis, when the metal coverage rate reaches 30% to 50%, the aneurysm lumen blood flow can be significantly reduced, and the cure rate is high. However, the application of the flow diversion device makes the patient rely on double antiplatelet therapy for a long time, and there is a risk of postoperative hemorrhagic complications. In addition, there is a certain risk of delayed rupture after treating some large aneurysms.

[0005] (3) There are also some new embolization devices, which are usually made of shape memory material and shaped into spherical, cylindrical or disc-shaped, delivered through catheter, pushed out from the sheath tube after reaching the specific location, self-expand to spherical shape, and then achieve the purpose of occluding aneurysm. For example, the first embolization device is provided, which is a spherical or cylindrical dense mesh device with rivet points at both ends. The whole device expands in the aneurysm cavity, and the aneurysm treatment is achieved by covering the aneurysm neck with the proximal dense mesh. Another second embolization device is provided, which is composed of a visible wire and a peripheral self-expanding memory alloy to form a three-dimensional mesh structure. It can be released and recovered through the catheter like a spring coil, and can be spherical when filling in the aneurysm, thereby playing a turbulence effect. A third embolization device is also provided, which is woven from double-layer nickel-titanium alloy. A fourth embolization device is also provided, which is woven from double-layer memory alloy. It is disc-shaped without restriction, and will be limited to tulip-shaped when released in the aneurysm, which can be stably placed at the lower part of the aneurysm and cover the aneurysm neck, thereby playing the role of reconstructing hemodynamics. However, the design of rivet points at the proximal end of the first embolization device makes the device a symmetrical structure, which makes the coverage of the aneurysm neck have orientation, and is mainly used for treating bifurcated wide-diameter aneurysms, and is especially suitable for regular aneurysms. Moreover, the design of rivet points at the distal end of the first embolization device has an impact on the aneurysm wall, which can easily lead to aneurysm wall rupture and aneurysm bleeding. In some cases, the proximal rivet point of the first embolization device can be herniated into the parent artery, affecting the endothelialization process of the aneurysm neck. In addition, the first embolization device is usually single spherical or cylindrical, although the contact area is large, but the supporting force is insufficient, and the long-term stability in the aneurysm cavity is not good, and the device is easy to shift. The second embolization device is shaped into a three-dimensional mesh structure by multiple sheet-shaped meshes, which is similar to a spherical shape. Due to the large friction between the three-dimensional mesh structure and the aneurysm wall, the stability of the device in the aneurysm is not good, and it is not easy to recover to the predetermined shape, which affects the filling effect, and the spring coil needs to be used, which is complicated to operate. The third embolization device has basically the same working principle as the first embolization device, so it also has the same problems. The proximal rivet point of the fourth embolization device is also prone to herniation into the parent artery under the pressure of the aneurysm wall, which is suitable for top aneurysms, and the device position needs to be repeatedly adjusted and placed, otherwise it will affect the stability of the device in the aneurysm, so the efficiency is low. In addition, the internal cavity of this kind of embolization device is large, and its stability is affected under the water hammer effect of blood, and the internal cavity has small resistance to blood flow in the aneurysm, which is not conducive to the formation of thrombus in the aneurysm.

[0006] In addition to the above problems, the above various structures are once expanded after being pushed out, which is only suitable for regular spherical aneurysms, and cannot be applied to irregular aneurysms such as long spherical and flat spherical aneurysms. SUMMARY

[0007] In order to solve at least one technical problem in the prior art, the present application aims to provide a vascular aneurysm occlusion device, a vascular aneurysm occlusion treatment device and a vascular aneurysm occlusion system, which are used for realizing occlusion treatment of vascular aneurysm and can be adapted to irregular aneurysm packing and have good forming effect.

[0008] In order to achieve the above-mentioned purpose, according to one aspect of the present application, a vascular aneurysm occlusion device is provided, which comprises a main occlusion structure in the form of a mesh tube, the main occlusion structure having a planar spiral unfolded state and a compressed state for being delivered from a blood vessel to a vascular aneurysm, and the mesh tube outer diameter of the main occlusion structure is uneven, so that the outer diameter distribution of the planar spiral when the main occlusion structure is unfolded is uneven.

[0009] Optionally, the vascular aneurysm occlusion device further comprises a distal guide structure arranged outside the main occlusion structure, a proximal end of the distal guide structure being connected to a distal end of the main occlusion structure, the distal guide structure having a spiral unfolded state and a compressed state for being delivered from a blood vessel to a vascular aneurysm; the spiral direction of the distal guide structure is the same as the spiral direction of the main occlusion structure.

[0010] Optionally, the ratio of the minimum mesh tube diameter to the maximum mesh tube diameter of the main occlusion structure is not less than 1:2, so that the ratio of the maximum outer diameter to the minimum outer diameter of the planar spiral when the main occlusion structure is unfolded is 1.5-1.8.

[0011] Optionally, the spiral outer diameter distribution of the distal guide structure when unfolded is uniform or uneven.

[0012] Optionally, the maximum planar height of the vascular aneurysm occlusion device when unfolded is not less than 1 / 4 of the maximum outer diameter of the planar spiral when the main occlusion structure is unfolded.

[0013] Optionally, the maximum planar height of the vascular aneurysm occlusion device when unfolded is 1 / 3-2 / 3 of the maximum outer diameter of the planar spiral when the main occlusion structure is unfolded.

[0014] Optionally, the maximum outer diameter of the spiral of the distal guide structure when unfolded is not greater than 1 / 2 of the maximum outer diameter of the planar spiral when the main occlusion structure is unfolded.

[0015] Optionally, the distal guide structure and the main occlusion structure are made of the same mesh tube.

[0016] Optionally, the main occlusion structure has at least one planar spiral when unfolded, the planar spiral is wound by one mesh tube, and the mesh tube has different shapes and / or sizes of cross sections when unfolded.

[0017] Optionally, the mesh tube is woven by woven wires, the wire diameter of the woven wires is 0.0008-0.002 inches, the number of the woven wires is 48-144, and the maximum outer diameter of the mesh tube is 2-8 mm.

[0018] Optionally, the maximum outer diameter of the planar spiral of the main occlusion structure when unfolded is 4-32 mm.

[0019] Optionally, the proximal end of the aneurysm occlusion device is fixed by a proximal end imaging marker, and / or the distal end of the aneurysm occlusion device is fixed by a distal end imaging marker.

[0020] To achieve the above-mentioned purposes, according to another aspect of the present application, the present application further provides an aneurysm occlusion treatment device comprising any one of the aneurysm occlusion devices and a push rod, the push rod being detachably connected to the proximal end of the main occlusion structure of the aneurysm occlusion device.

[0021] Optionally, the push rod extends along the tangent direction of the spiral line of the planar spiral when the main occlusion structure is unfolded.

[0022] To achieve the above-mentioned purposes, according to still another aspect of the present application, the present application further provides an aneurysm occlusion system comprising any one of the aneurysm occlusion devices and a microcatheter, the aneurysm occlusion device being compressed in the microcatheter and being capable of recovering to the unfolded state after being separated from the microcatheter.

[0023] Compared with the prior art, the aneurysm occlusion device, the aneurysm occlusion treatment device and the aneurysm occlusion system provided by the present application have the following advantages:

[0024] Firstly, the aneurysm occlusion device comprises a main occlusion structure in the form of a mesh tube, the main occlusion structure has an unfolded state in the form of a planar spiral and a compressed state for being delivered from a blood vessel to an aneurysm, and the mesh tube outer diameter of the main occlusion structure is uneven, so that the outer diameter of the planar spiral when the main occlusion structure is unfolded is unevenly distributed; such a configuration makes the aneurysm occlusion device not only capable of forming a continuous dense mesh covering surface at the aneurismal neck through the mesh tube side wall of the main occlusion structure, but also capable of adapting to more aneurismal shapes and positions, especially the uneven mesh tube outer diameter of the main occlusion structure can improve the compliance of the aneurysm occlusion device to irregular aneurismal cavities, improve the forming effect, so that the aneurysm occlusion device is particularly suitable for filling irregular aneurysms such as long spherical or flat spherical aneurysms, and the treatment range of the aneurysm occlusion device is improved; and the planar spiral structure of the main occlusion structure when unfolded can improve the spatial division in the aneurismal cavity, promote the turbulence effect and thrombosis, and promote the formation of intraneurysmal thrombus, and accelerate the embolization of aneurysm;

[0025] Second, the above-mentioned aneurysm occlusion device preferably guides the filling process of the main occlusion structure by the distal guide structure, so that the entire aneurysm occlusion device is not expanded and shaped at one time when it is pushed out of the microcatheter, the filling is more stable, and it is easier to rotate and shape;

[0026] Third, the above-mentioned aneurysm occlusion device is filled by a spiral shape, so that the distal rivet point is in the aneurysm cavity and does not directly contact the aneurysm wall, reducing the influence of the aneurysm occlusion device on the aneurysm wall; at the same time, the proximal rivet point is parallel to the aneurysm wall and can be pressed between the main occlusion structure and the aneurysm wall, without affecting the coverage of the aneurysm neck and with good stability. BRIEF DESCRIPTION OF DRAWINGS

[0027] The implementation method of the present application and the features, properties and advantages of the related embodiments will be described by combining the following drawings, in which:

[0028] Figure 1 is a top view structural schematic diagram of the aneurysm occlusion device of preferred embodiment one of the present application, wherein the distal guide structure has one oval spiral when expanded, and the main occlusion structure has one spiral which is generally oval when expanded;

[0029] Figure 2a is a top view structural schematic diagram of the aneurysm occlusion device of preferred embodiment two of the present application, wherein the distal guide structure has 1.5 circular spirals when expanded, and the main occlusion structure has 1.5 spirals which are generally oval when expanded;

[0030] Figure 2b is Figure 2a a front view structural schematic diagram of the aneurysm occlusion device in

[0031] Figure 3 is a state diagram of the aneurysm occlusion device of preferred embodiment two of the present application in the aneurysm fully released;

[0032] Figure 4 is a top view structural schematic diagram of the aneurysm occlusion device of preferred embodiment three of the present application, wherein the distal guide structure has two spirals which are generally oval when expanded, and the main occlusion structure has two spirals which are generally oval when expanded.

[0033] In the drawings: 10, 20, 30 - aneurysm occlusion device; 40 - aneurysm; 41 - aneurysm neck; 50 - aneurysm-carrying artery; 11, 21, 31 - main occlusion structure; 12, 22, 32 - distal guide structure; a - proximal end of the aneurysm occlusion device; b - distal end of the aneurysm occlusion device; A - maximum outer diameter of the planar spiral; B - minimum outer diameter of the planar spiral; D - maximum outer diameter of the distal guide structure; d - maximum diameter of the mesh tube in the main occlusion structure. DETAILED DESCRIPTION

[0034] To make the objectives, advantages, and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to facilitate and clearly illustrate the objectives of the embodiments of the present invention.

[0035] As used herein, the singular forms “a,” “an,” and “the” include plural objects unless otherwise expressly stated. As used herein, the term “or” is generally used to include the meaning of “and / or” unless otherwise expressly stated. As used herein, the term “a plurality” is generally used to include the meaning of two or more unless otherwise expressly stated. As used herein, the term “several” is generally used to include the meaning of an indefinite quantity unless otherwise expressly stated. As used herein, the term “proximal” generally refers to the end closer to the operator of the device, and “distal” generally refers to the end into which the device first enters the body, unless otherwise expressly stated.

[0036] The core idea of ​​this invention is to provide a hemangioma occlusion device, comprising a mesh-like main occlusion structure. This main occlusion structure has an unfolded state and a compressed state. When the entire hemangioma occlusion device is delivered within a microcatheter, the main occlusion structure is in a compressed state. In this state, the radial dimension of the main occlusion structure is typically compressed, while the axial dimension is elongated. The outer diameter of the entire hemangioma occlusion device is small, facilitating delivery of the device through narrow blood vessels by the microcatheter. When the entire hemangioma occlusion device is pushed out of the microcatheter, the main occlusion structure returns to its unfolded state. In this state, the main occlusion structure autonomously returns to a planar spiral shape, and the outer diameter of the planar spiral is unevenly distributed, i.e., the outer diameters of the planar spirals are inconsistent, allowing the main occlusion structure to adapt to irregularly shaped aneurysms. It is understood that the uneven planar spiral shape during unfolding is mainly due to the uneven cross-sectional diameter of the mesh tube. This uneven cross-sectional diameter improves the compliance of the hemangioma occlusion device with irregular aneurysm cavities and enhances the shaping effect. Therefore, the uneven outer diameter of the mesh tubes in the main sealing structure results in an uneven distribution of the outer diameter of the planar spiral when the main sealing structure is deployed. It should be understood that "irregular" generally refers to a shape without a predictable pattern. Typically, irregularly shaped aneurysms mainly refer to non-spherical aneurysms, such as elongated spherical or oblate spherical aneurysms, or other non-spherical aneurysms. Elongated spherical or oblate spherical shapes refer to non-uniform geometric shapes, such as elliptical or near-elliptical structures resembling spindles or olives. Compared to oblate spheroids, elongated spherical shapes have a larger ratio of maximum outer diameter (e.g., the major axis of an ellipse) to minimum outer diameter (e.g., the minor axis of an ellipse), making the geometry more flattened. However, it should be understood that the aneurysm sealing device of the present invention is not limited to aneurysms and can also be used for aneurysms occurring in other blood vessels.

[0037] The present invention will now be described in more detail with reference to the accompanying drawings and preferred embodiments. Unless otherwise specified, the following embodiments and features can complement or combine with each other.

[0038] <Example 1>

[0039] refer to Figure 1 The preferred embodiment of the present invention provides a hemangioma closure device 10 for the treatment of hemangiomas, especially intracranial aneurysms. In particular, the hemangioma closure device 10 is suitable for the treatment of irregularly shaped aneurysms.

[0040] The aneurysm occlusion device 10 includes a main occlusion structure 11 in the form of a mesh tube. Preferably, the aneurysm occlusion device 10 also includes a distal guide structure 12 disposed outside the main occlusion structure 11. The main occlusion structure 11 is a mesh tube-shaped structure with a planar spiral unfolded state and a compressed state for delivery from inside the blood vessel to the aneurysm. Specifically, the main occlusion structure 11 is in the compressed state when inside the microcatheter and will automatically return to the unfolded state after the microcatheter is pushed out. Moreover, the outer diameter of the mesh tubes of the main occlusion structure 11 is uneven (i.e., the outer diameters of the mesh tubes are not equal), which makes the outer diameter distribution of the planar spirals when the main occlusion structure 11 unfolds uneven. That is, the planar spirals of the main occlusion structure 11 have different outer diameters when unfolded, making the aneurysm occlusion device 10 suitable for irregular aneurysm morphologies. Here, it should be understood that the shape of the planar spirals of the main occlusion structure 11 when unfolded is non-circular, and the outer diameter of the planar spirals when unfolded refers to the outer diameter of the outermost spiral. In this article, the first spiral starts from the farthest end of the main sealing structure 11, and the last spiral is the outermost spiral.

[0041] In this embodiment, the planar spiral shape of the main sealing structure 11 when unfolded is elliptical or near-elliptical, suitable for the morphology of oblate spheroidal aneurysms, overcoming the defect that various aneurysm sealing structures in the prior art are only applicable to regular spherical aneurysms. Moreover, since the outer surface of the main sealing structure 11 is a mesh surface with uniform and continuous pores, the entire outer surface of the main sealing structure 11 can be used to cover the aneurysm neck, giving the aneurysm sealing device 10 a certain degree of isotropy, and it is suitable for filling aneurysms at bifurcation and sidewall, thus expanding the treatment range. In addition, the proximal end a of the entire aneurysm sealing device 10 is the proximal end a of the main sealing structure 11, and the proximal end a can be pressed between the main sealing structure 11 and the aneurysm wall, making the proximal end a parallel to the aneurysm wall. While reducing the impact on the aneurysm wall, it can also achieve continuous coverage at the aneurysm neck, with a high metal coverage rate at the aneurysm neck opening.

[0042] The main occlusion structure 11, when deployed, includes at least one planar spiral. Preferably, the main occlusion structure 11 has two to four spirals when deployed. However, in practice, the number of spirals in the main occlusion structure 11 when deployed can be set according to the size of the aneurysm. For example, a smaller number of planar spirals is suitable for treating small aneurysms, while an increase in the number of planar spirals allows for the treatment of larger aneurysms.

[0043] like Figure 1As shown, in a specific example, the main sealing structure 11 has one turn of planar spiral when unfolded. This one turn of planar spiral is approximately elliptical, therefore, the outer diameter distribution of the planar spiral when unfolded is uneven. More specifically, the planar spiral of the main sealing structure 11 when unfolded has a maximum outer diameter A and a minimum outer diameter B. The maximum outer diameter A can be understood as the length of the major axis of the ellipse, and the minimum outer diameter B can be understood as the length of the minor axis of the ellipse, with its major axis direction parallel to the plane where the aneurysm neck is located. In this embodiment, the outer diameter of the planar spiral refers to the outer diameter projected onto the outermost planar spiral in a projection plane perpendicular to the axis of the planar spiral.

[0044] In this embodiment, the main sealing structure 11 is formed by a pre-shaped spiral winding of a mesh tube, preferably woven from braided wire. The material of the braided wire preferably includes a shape memory material, which can be a metallic material with shape memory function, such as nickel-titanium (Ni-Ti) alloy, nickel-titanium-cobalt alloy (Ni-Ti-Co), double-layer composite metal wire (Ni-Ti@Pt), etc. The material of the braided wire can also be a polymer material with a certain shape recovery capability, such as poly(p-dioxanone) (PDO), (lactide-ε-caprolactone) copolymer (PLC), polyurethane (PU), polynorbornene amorphous polymer, etc., or a combination of these materials. Here, the braided wire uses a shape memory metallic material or a polymer material with a certain shape recovery capability, enabling the mesh to remember and recover its original shape. Preferably, the main sealing structure 11 is woven from developable braided wire, or the main sealing structure 11 is woven from a mixture of developable and non-developable braided wire. This design allows the main sealing structure 11 to be developed under X-rays while maintaining its elasticity, giving it strong resilience and the ability to retain its original shape. The present invention does not impose any particular limitation on the developing material of the developable braided filament; for example, the developing material may include, but is not limited to, one or an alloy of radiopaque materials such as platinum (Pt), iridium (Ir), gold (Au), silver, tantalum, and tungsten.

[0045] In one example, the mesh tube can be made by weaving shape memory alloy wires (such as Ni-Ti) with a metal wire with good developability. In another example, the mesh tube can also be woven from a composite wire (DFT) of shape memory alloy material and developable material. The composite wire DFT includes a sleeve and a core wire, the sleeve covering the core wire, the sleeve being made of shape memory alloy material, and the core wire being made of developable material.

[0046] Furthermore, the diameter of the braided filaments can be 0.0008in to 0.002in, the number of braided filaments can be 48 to 144, and the maximum diameter d of the mesh tube can be 2mm to 8mm. Optionally, the maximum outer diameter A of the planar spiral of the main sealing structure 11 when unfolded can be 4mm to 32mm.

[0047] Continue reading Figure 1 When the outer diameter distribution of the planar spiral of the main sealing structure 11 is uneven during deployment, the cross-sectional shape and / or size of the mesh tube are different, making the cross-section of the mesh tube uneven throughout the extension path of the entire planar spiral, such as a combination of circles and ellipses. The different cross-sections constitute a planar spiral structure with an overall uneven outer diameter.

[0048] Furthermore, the ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spiral when the main sealing structure 11 is deployed should not be too small. If it is too small, it cannot effectively fill irregular aneurysms. Preferably, the ratio between the minimum network diameter and the maximum network diameter of the main sealing structure 11 is not less than 1:2, so that the ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spiral when the main sealing structure 11 is deployed is 1.5 to 1.8. Figure 1 In the example, the ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spiral when the main sealing structure 11 is deployed is 1.5.

[0049] As described above, the aneurysm occlusion device 10 preferably further includes a distal guide structure 12. The proximal end of the distal guide structure 12 is connected to the distal end of the main occlusion structure 11, meaning the distal guide structure 12 is entirely disposed outside the main occlusion structure 11 and located at the distal end of the main occlusion structure 11. Similarly, the distal guide structure 12 has a spiral-shaped unfolded state and a compressed state for delivery from within the blood vessel to the aneurysm. When the distal guide structure 12 is inside the microcatheter, it is in the compressed state; when the microcatheter is removed, it automatically returns to the unfolded state. The spiral of the distal guide structure 12 during unfolding can be a planar spiral (i.e., a two-dimensional spiral) or a three-dimensional spiral. The spiral direction of the distal guide structure 12 can be the same as or different from the spiral direction of the main occlusion structure 11; preferably, the spiral direction of the distal guide structure 12 is the same as the spiral direction of the main occlusion structure 11.

[0050] The distal guide structure 12, when deployed, can have a spiral structure with a uniform or non-uniform outer diameter distribution, such as... Figure 1The distal guide structure 12 has one regular elliptical spiral. The number of spirals when the distal guide structure 12 is deployed is also set according to the size of the aneurysm, and therefore is not limited to one spiral. For the treatment of small aneurysms, a distal guide structure 12 with fewer spirals can be selected, while for larger aneurysms, a distal guide structure 12 with more spirals can be selected.

[0051] When compressed within the microcatheter, the distal guide structure 12 generally takes the form of a slender linear structure, with the outer diameter of its spiral body being much smaller than the outer diameter of the network tube of the main occlusion structure 11. The distal guide structure 12 serves two purposes: firstly, it guides the main occlusion structure 11 during its initial release, guiding its rotation within the aneurysm cavity and sequentially covering the inner wall of the aneurysm until it is completely released; secondly, after the main occlusion structure 11 is released, the distal guide structure 12 provides internal support, increasing the overall stability of the entire aneurysm occlusion device when filling large aneurysms, making it less susceptible to compression and displacement. Furthermore, due to the small outer diameter of the spiral body of the distal guide structure 12, it is relatively flexible, reducing the impact of the entire aneurysm occlusion device on the aneurysm wall. In addition, the outline shape of the spiral structure of the distal guide structure 12 in its unfolded state, besides… Figure 1 Besides the regular elliptical spiral structure shown, there are of course other regular or irregular spiral structures, and there are no particular limitations on this.

[0052] The distal guide structure 12 can be integrally formed with the main sealing structure 11. For example, it can be manufactured by rotating, winding, compressing, and shaping the same mesh tube, so that the entire mesh tube presents a structure that is slender at the distal end, expanded in the middle, and compressed at the proximal end. Of course, in other embodiments, the distal guide structure 12 can also be separately formed from the main sealing structure 11. That is, after the two are manufactured separately, the distal guide structure 12 is fixed to the distal end of the main sealing structure 11. Compared with separate molding, the integral molding process is simpler and does not require additional connection processing at the distal end of the main sealing structure 11 and the proximal end of the distal guide structure 12.

[0053] Furthermore, the maximum planar height of the aneurysm occlusion device 10 when deployed is not less than 1 / 4 of the maximum outer diameter A of the planar spiral of the main occlusion structure 11 when deployed, and more preferably, the maximum planar height is 1 / 3 to 2 / 3 of the maximum outer diameter A of the planar spiral of the main occlusion structure 11 when deployed. In one specific embodiment, the maximum planar height of the aneurysm occlusion device 10 when deployed is 0.5 times the maximum outer diameter A of the planar spiral of the main occlusion structure 11 when deployed. It should be understood that the maximum planar height of the aneurysm occlusion device 10 when deployed refers to the maximum height of the entire aneurysm occlusion device in the direction perpendicular to the plane of the planar spiral, and its planar height is perpendicular to the plane where the aneurysm neck is located.

[0054] The distal guide structure 12 has at least one helix, and the outer diameter of the first helix starting from its distal end is the same as the inner diameter of the subsequent helixes, so that the subsequent helixes can cover the preceding helixes. Further, the maximum outer diameter D of the helix of the distal guide structure 12 when deployed is not greater than 1 / 2 of the maximum outer diameter A of the planar helix of the main sealing structure 12 when deployed. In this embodiment, the maximum outer diameter D of the helix of the distal guide structure 12 when deployed is 1 / 2 of the maximum outer diameter A of the planar helix of the main sealing structure 11 when deployed.

[0055] Continue reading Figure 1 Preferably, the proximal end a of the main sealing structure 11 is bound and fixed by a proximal imaging marker, which binds and fixes the proximal braided wire ends together to form a non-invasive proximal end a, avoiding any impact on the tumor wall. Preferably, the distal end b of the distal guiding structure 12 (i.e., the distal end of the entire device) is bound and fixed by a distal imaging marker, which binds and fixes the distal braided wire ends together to form a non-invasive distal end b. The proximal imaging marker and the distal imaging marker can be imaging sleeves.

[0056] In one specific embodiment, such as Figure 1 As shown, the main blocking structure 11 has one generally elliptical planar spiral when deployed, and the distal guide structure 12 has one generally elliptical spiral when deployed. The ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spiral of the main blocking structure 11 when deployed is 1.5. The maximum planar height of the aneurysm blocking device 10 when deployed is 0.5 times the maximum outer diameter A of the planar spiral of the main blocking structure 11 when deployed. The maximum outer diameter D of the spiral of the distal guide structure 12 when deployed is 1 / 2 of the maximum outer diameter A of the planar spiral of the main blocking structure 11 when deployed. This allows the aneurysm blocking device 10 to be suitable for filling irregular spherical aneurysms. The long axis direction (i.e., the direction of the maximum outer diameter) of the main blocking structure 11 is parallel to the plane where the aneurysm neck is located.

[0057] <Example 2>

[0058] refer to Figure 2a and Figure 2b A preferred embodiment of the present invention provides a hemangioma closure device 20, which is also used to achieve the closure treatment of hemangiomas, especially the treatment of intracranial aneurysms. In particular, the hemangioma closure device 20 is suitable for the closure treatment of aneurysms with irregular shapes.

[0059] The aneurysm closure device 20 includes a main closure structure 21 in the form of a mesh tube. Preferably, the aneurysm closure device 20 also includes a distal guide structure 22 disposed outside the main closure structure 21. The main closure structure 21 is a mesh tube-shaped structure with a planar spiral unfolded state and a compressed state for delivery from inside the blood vessel to the aneurysm. Specifically, the main closure structure 21 is in a compressed state when inside the microcatheter and automatically returns to the unfolded state after the microcatheter is pushed out. Moreover, the outer diameter of the mesh tubes of the main closure structure 21 is uneven (i.e., the outer diameters of the mesh tubes are not equal), resulting in an uneven distribution of the outer diameter of the planar spiral when the main closure structure 21 is unfolded. That is, the planar spirals of the main closure structure 21 have different outer diameters when unfolded, making the aneurysm closure device 20 suitable for irregular aneurysm morphologies. Here, it should be understood that the shape of the planar spiral of the main closure structure 21 when unfolded is non-circular, and the outer diameter of the planar spiral when unfolded refers to the outer diameter of the outermost spiral. In this article, the first spiral starts from the farthest end of the main sealing structure 21, and the last spiral is the outermost spiral.

[0060] In this embodiment, the planar spiral shape of the main sealing structure 21 when unfolded is elliptical or near-elliptical, suitable for oblate spherical aneurysms, overcoming the limitation of existing aneurysm sealing structures that are only applicable to regular spherical aneurysms. Furthermore, since the outer surface of the main sealing structure 21 is a uniform and continuous mesh surface, the entire outer surface of the main sealing structure 21 can be used to cover the aneurysm neck, giving the aneurysm sealing device 20 a certain degree of isotropy. It is suitable for filling aneurysms at bifurcation and lateral wall locations, thus broadening the treatment range. In addition, the proximal end a of the entire aneurysm sealing device 20 is the proximal end a of the main sealing structure 21, and proximal end a can be pressed between the main sealing structure 21 and the aneurysm wall, making proximal end a parallel to the aneurysm wall. This reduces the impact on the aneurysm wall while achieving continuous coverage at the aneurysm neck, resulting in a high metal coverage rate at the aneurysm neck opening.

[0061] The main occlusion structure 21, when deployed, includes at least one planar spiral; preferably, it has two to four spirals. However, in practice, the number of spirals in the main occlusion structure 21 when deployed can be set according to the size of the aneurysm. For example, fewer planar spirals are suitable for treating small aneurysms, while an increase in the number of planar spirals allows for the treatment of larger aneurysms.

[0062] like Figure 2a As shown, in a specific example, the main sealing structure 21 has 1.5 turns of planar spiral when unfolded. This 1.5 turns of planar spiral is approximately elliptical, therefore, the outer diameter distribution of the planar spiral when unfolded is uneven. More specifically, the planar spiral of the main sealing structure 21 when unfolded has a maximum outer diameter A and a minimum outer diameter B. The maximum outer diameter A can be understood as the length of the major axis of the ellipse, and the minimum outer diameter B can be understood as the length of the minor axis of the ellipse. The direction of its major axis is parallel to the plane where the aneurysm neck is located. In this embodiment, the outer diameter of the planar spiral refers to the outer diameter projected onto the outermost planar spiral in a projection plane perpendicular to the axis of the planar spiral.

[0063] In this embodiment, the main sealing structure 21 is formed by a pre-shaped spiral winding of a mesh tube, preferably woven from braided wire. The material of the braided wire preferably includes a shape memory material, which can be a metallic material with shape memory function, such as nickel-titanium (Ni-Ti) alloy, nickel-titanium-cobalt alloy (Ni-Ti-Co), double-layer composite metal wire (Ni-Ti@Pt), etc. The material of the braided wire can also be a polymer material with a certain shape recovery capability, such as poly(p-dioxanone) (PDO), (lactide-ε-caprolactone) copolymer (PLC), polyurethane (PU), polynorbornene amorphous polymer, etc., or a combination of these materials. Here, the braided wire uses a shape memory metallic material or a polymer material with a certain shape recovery capability, enabling the mesh to remember and recover its original shape. Preferably, the main sealing structure 21 is woven from developable braided wire, or the main sealing structure 21 is woven from a mixture of developable and non-developable braided wire. This design allows the main sealing structure 21 to be developed under X-rays while maintaining its elasticity, giving it strong resilience and the ability to retain its original shape. The present invention does not specifically limit the developing material of the developable braided filament; for example, the developing material includes, but is not limited to, one or an alloy of radiopaque materials such as platinum (Pt), iridium (Ir), gold (Au), silver, tantalum, and tungsten.

[0064] In one example, the mesh tube can be made by weaving shape memory alloy wires (such as Ni-Ti) with a metal wire with good developability. In another example, the mesh tube can also be woven from a composite wire (DFT) of shape memory alloy material and developable material. The composite wire DFT includes a sleeve and a core wire, the sleeve covering the core wire, the sleeve being made of shape memory alloy material, and the core wire being made of developable material.

[0065] Furthermore, the diameter of the braided filaments can be 0.0008in to 0.002in, the number of braided filaments can be 48 to 144, and the maximum diameter d of the mesh tube can be 2mm to 8mm. Optionally, the maximum outer diameter A of the planar spiral of the main sealing structure 11 when unfolded can be 4mm to 32mm.

[0066] Referring to Figure 2, when the outer diameter distribution of the planar spiral of the main sealing structure 21 is uneven during unfolding, the cross-sectional shape and / or size of the mesh tube are different, making the cross-section of the mesh tube uneven throughout the extension path of the entire planar spiral, such as presenting a combination of circles and ellipses. The different cross-sections constitute a planar spiral structure with an overall uneven outer diameter.

[0067] Furthermore, the ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spiral when the main sealing structure 21 is deployed should not be too small. If it is too small, it cannot effectively fill irregular aneurysms. Preferably, the ratio between the minimum network diameter and the maximum network diameter of the main sealing structure 21 is not less than 1:2, so that the ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spiral when the main sealing structure 21 is deployed is 1.5 to 1.8. Figure 2a and Figure 2b In the example, the ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spiral when the main sealing structure 21 is deployed is 1.6.

[0068] As described above, the aneurysm occlusion device 20 preferably further includes a distal guide structure 22. The proximal end of the distal guide structure 22 is connected to the distal end of the main occlusion structure 21, meaning the distal guide structure 22 is entirely disposed outside the main occlusion structure 21 and located at the distal end of the main occlusion structure 21. Similarly, the distal guide structure 22 has a spiral-shaped unfolded state and a compressed state for delivery from within the blood vessel to the aneurysm. When the distal guide structure 22 is inside the microcatheter, it is in the compressed state; when the microcatheter is removed, it automatically returns to the unfolded state. The spiral of the distal guide structure 22 during unfolding can be a planar spiral (i.e., a two-dimensional spiral) or a three-dimensional spiral. The spiral direction of the distal guide structure 22 can be the same as or different from the spiral direction of the main occlusion structure 21; preferably, the spiral direction of the distal guide structure 22 is the same as the spiral direction of the main occlusion structure 21.

[0069] The distal guide structure 22, when deployed, can have a spiral structure with a uniform or non-uniform outer diameter distribution, such as... Figure 2a The distal guide structure 22 has 1.5 regular circular spirals. The number of spirals when the distal guide structure 22 is deployed is also set according to the size of the aneurysm, and therefore is not limited to 1.5 spirals. For the treatment of small aneurysms, a distal guide structure 22 with fewer spirals can be selected, while for larger aneurysms, a distal guide structure 22 with more spirals can be selected.

[0070] When compressed within the microcatheter, the distal guide structure 22 generally takes the form of a slender linear structure, with the outer diameter of its spiral body being much smaller than the outer diameter of the network tube of the main occlusion structure 21. The distal guide structure 22 serves two purposes: firstly, it guides the main occlusion structure 21 during its initial release, guiding its rotation within the aneurysm cavity and sequentially covering the inner wall of the aneurysm until it is completely released; secondly, after the main occlusion structure 21 is released, the distal guide structure 22 provides internal support, increasing the overall stability of the entire aneurysm occlusion device when filling large aneurysms, making it less susceptible to compression and displacement. Furthermore, due to the small outer diameter of the spiral body of the distal guide structure 22, it is generally more flexible, reducing the impact of the entire aneurysm occlusion device on the aneurysm wall. In addition, the outline shape of the spiral structure of the distal guide structure 22 in its unfolded state can be, except... Figure 2a Besides the regular circular spiral structure shown, other regular or irregular spiral structures are also possible, without any particular limitation.

[0071] The distal guide structure 22 can be integrally formed with the main sealing structure 21. For example, it can be manufactured by rotating, winding, compressing, and shaping the same mesh tube, so that the entire mesh tube presents a structure that is slender at the distal end, expanded in the middle, and compressed at the proximal end. Of course, in other embodiments, the distal guide structure 22 can also be separately formed from the main sealing structure 21. That is, after the two are manufactured separately, the distal guide structure 22 is fixed to the distal end of the main sealing structure 21. Compared with separate molding, the integral molding process is simpler and does not require additional connection processing at the distal end of the main sealing structure 21 and the proximal end of the distal guide structure 22.

[0072] Furthermore, the maximum planar height of the aneurysm occlusion device 20 when deployed is not less than 1 / 4 of the maximum outer diameter A of the planar spiral of the main occlusion structure 21 when deployed, and more preferably, the maximum planar height is 1 / 3 to 2 / 3 of the maximum outer diameter A of the planar spiral of the main occlusion structure 21 when deployed. In one specific embodiment, the maximum planar height of the aneurysm occlusion device 20 when deployed is 2 / 3 of the maximum outer diameter A of the planar spiral of the main occlusion structure 21 when deployed. It should be understood that the maximum planar height of the aneurysm occlusion device 20 when deployed refers to the maximum height of the entire aneurysm occlusion device in the plane perpendicular to the plane of the planar spiral, and its planar height is perpendicular to the plane where the aneurysm neck is located.

[0073] The distal guide structure 22 has at least one helix, and the outer diameter of the first helix starting from its distal end is the same as the inner diameter of the subsequent helixes, so that the subsequent helixes can cover the preceding helixes. Further, the maximum outer diameter D of the helix of the distal guide structure 22 when deployed is not greater than 1 / 2 of the maximum outer diameter A of the planar helix of the main sealing structure 22 when deployed. In this embodiment, for example, the maximum outer diameter D of the helix of the distal guide structure 22 when deployed is 4 / 5 of the maximum outer diameter A of the planar helix of the main sealing structure 21 when deployed.

[0074] Referring again to Figure 2, the proximal end a of the main sealing structure 21 is preferably secured by a proximal imaging marker, which binds and fixes the proximal braided wire ends together to form a non-invasive proximal end a, avoiding any impact on the tumor wall. Preferably, the distal end b (i.e., the distal end of the entire device) of the distal guiding structure 22 is secured and fixed by a distal imaging marker, which binds and fixes the distal braided wire ends together to form a non-invasive distal end b. The proximal imaging marker and the distal imaging marker can be imaging sleeves.

[0075] In a specific embodiment, such as Figure 2a As shown, the main blocking structure 21 has 1.5 turns of a generally elliptical planar spiral when deployed, and the distal guide structure 22 has 1.5 turns of a generally circular spiral when deployed. The ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spiral of the main blocking structure 21 when deployed is 1.6. The maximum planar height of the aneurysm blocking device 20 when deployed is 2 / 3 of the maximum outer diameter A of the planar spiral of the main blocking structure 21 when deployed. The maximum outer diameter D of the spiral of the distal guide structure 22 when deployed is 4 / 5 of the maximum outer diameter A of the planar spiral of the main blocking structure 21 when deployed. This makes the aneurysm blocking device 20 suitable for filling flattened spherical wide-necked aneurysms. The long axis direction (i.e., the direction of the maximum outer diameter) of the main blocking structure 21 is parallel to the plane where the aneurysm neck is located.

[0076] See Figure 3When the aneurysm occlusion device 20 is fully released and inserted into the flattened spherical aneurysm 40, the outer surface of the main occlusion structure 21 is a uniform and continuous mesh surface that covers the aneurysm neck 41. Furthermore, the proximal end a of the entire aneurysm occlusion device is compressed between the aneurysm wall and the outer surface of the mesh, ensuring that the proximal imaging marker is parallel to the tangential direction of the aneurysm wall. This reduces the impact on the aneurysm wall, does not affect the continuous coverage at the aneurysm neck, and does not protrude into the parent artery 50. The distal guide structure 22 guides the main occlusion structure 21 to rotate within the aneurysm cavity and sequentially cover the inner wall of the aneurysm 40 until the main occlusion structure 21 is completely released.

[0077] <Example 3>

[0078] refer to Figure 4 A preferred embodiment of the present invention provides a hemangioma occlusion device 30, which is also used to achieve the occlusion treatment of hemangiomas, especially the treatment of intracranial aneurysms. In particular, the hemangioma occlusion device 30 is suitable for the occlusion treatment of aneurysms with irregular shapes.

[0079] The aneurysm occlusion device 30 includes a main occlusion structure 31 in the form of a mesh tube. Preferably, the aneurysm occlusion device 30 also includes a distal guide structure 32 disposed outside the main occlusion structure 31. The main occlusion structure 31 is a mesh tube-shaped structure with a planar spiral unfolded state and a compressed state for delivery from inside the blood vessel to the aneurysm. Specifically, the main occlusion structure 31 is in the compressed state when inside the microcatheter and will automatically return to the unfolded state after the microcatheter is pushed out. Moreover, the outer diameter of the mesh tubes of the main occlusion structure 31 is uneven (i.e., the outer diameters of the mesh tubes are not equal), which makes the outer diameter distribution of the planar spirals when the main occlusion structure 31 unfolds uneven. That is, the planar spirals of the main occlusion structure 31 have different outer diameters when unfolded, making the aneurysm occlusion device 30 suitable for irregular aneurysm morphologies. Here, it should be understood that the shape of the planar spirals of the main occlusion structure 31 when unfolded is non-circular, and the outer diameter of the planar spirals when unfolded refers to the outer diameter of the outermost spiral. In this article, the first spiral starts from the farthest end of the main sealing structure 31, and the last spiral is the outermost spiral.

[0080] In this embodiment, the planar spiral shape of the main sealing structure 31 when unfolded is elliptical or near-elliptical, suitable for elongated spherical aneurysms, overcoming the limitation of existing aneurysm sealing structures that are only applicable to regular spherical aneurysms. Furthermore, since the outer surface of the main sealing structure 31 is a uniformly sized and continuous mesh, the entire outer surface of the main sealing structure 31 can be used to cover the aneurysm neck, giving the aneurysm sealing device 30 a certain degree of isotropy. It is suitable for filling aneurysms at bifurcation and lateral wall locations, thus broadening the treatment range. In addition, the proximal end a of the entire aneurysm sealing device 30 is the same as the proximal end a of the main sealing structure 31, and proximal end a can be pressed between the main sealing structure 31 and the aneurysm wall, making proximal end a parallel to the aneurysm wall. This reduces the impact on the aneurysm wall while achieving continuous coverage at the aneurysm neck, resulting in a high metal coverage rate at the aneurysm neck opening.

[0081] The main occlusion structure 31, when deployed, has at least one planar spiral. Preferably, the main occlusion structure 31 has two to four spirals when deployed. However, in practice, the number of spirals in the main occlusion structure 31 when deployed can be set according to the size of the aneurysm. For example, a smaller number of planar spirals is suitable for treating small aneurysms, while an increase in the number of planar spirals can treat larger aneurysms.

[0082] like Figure 4 As shown, in a specific example, the main sealing structure 31 has two turns of planar spiral when unfolded. These two turns of planar spiral are approximately elliptical, therefore, the outer diameter distribution of the planar spiral when unfolded is uneven. More specifically, the planar spiral of the main sealing structure 31 when unfolded has a maximum outer diameter A and a minimum outer diameter B. The maximum outer diameter A can be understood as the major axis length of the ellipse, and the minimum outer diameter B can be understood as the minor axis length of the ellipse. The direction of its major axis is perpendicular to the plane where the aneurysm neck is located. In this embodiment, the outer diameter of the planar spiral refers to the outer diameter projected onto the outermost planar spiral within a projection plane perpendicular to the axis of the planar spiral.

[0083] In this embodiment, the main sealing structure 311 is formed by a pre-shaped spiral winding of a mesh tube, preferably woven from braided wire. The material of the braided wire preferably includes a shape memory material, which can be a metallic material with shape memory function, such as nickel-titanium (Ni-Ti) alloy, nickel-titanium-cobalt alloy (Ni-Ti-Co), double-layer composite metal wire (Ni-Ti@Pt), etc. The material of the braided wire can also be a polymer material with a certain shape recovery capability, such as poly(p-dioxanone) (PDO), (lactide-ε-caprolactone) copolymer (PLC), polyurethane (PU), polynorbornene amorphous polymer, etc., or a combination of these materials. Here, the braided wire uses a shape memory metallic material or a polymer material with a certain shape recovery capability, enabling the mesh to remember and recover its original shape. Preferably, the main sealing structure 31 is woven from a developable braided wire, or the main sealing structure 31 is woven from a mixture of developable and non-developable braided wires. This design allows the main sealing structure 31 to be developed under X-rays while maintaining its elasticity, giving it strong resilience and the ability to retain its original shape. The present invention does not specifically limit the developing material of the developable braided filament; for example, the developing material includes, but is not limited to, one or an alloy of radiopaque materials such as platinum (Pt), iridium (Ir), gold (Au), silver, tantalum, and tungsten.

[0084] In one example, the mesh tube can be made by weaving shape memory alloy wires (such as Ni-Ti) with a metal wire with good developability. In another example, the mesh tube can also be woven from a composite wire (DFT) of shape memory alloy material and developable material. The composite wire DFT includes a sleeve and a core wire, the sleeve covering the core wire, the sleeve being made of shape memory alloy material, and the core wire being made of developable material.

[0085] Furthermore, the diameter of the braided filaments can be 0.0008in to 0.002in, the number of braided filaments can be 48 to 144, and the maximum diameter d of the mesh tube can be 2mm to 8mm. Optionally, the maximum outer diameter A of the planar spiral of the main sealing structure 31 when unfolded can be 4mm to 32mm.

[0086] Continue reading Figure 4 When the outer diameter distribution of the planar spiral of the main sealing structure 31 is uneven during deployment, the cross-sectional shape and / or size of the mesh tube are actually different, making the cross-section of the mesh tube uneven in the entire extension path of the planar spiral, such as a combination of circles and ellipses. The different cross-sections constitute a planar spiral structure with an uneven overall outer diameter.

[0087] Furthermore, the ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spiral when the main sealing structure 31 is deployed should not be too small. If it is too small, it cannot effectively fill irregular aneurysms. Preferably, the ratio between the minimum network diameter and the maximum network diameter of the main sealing structure 31 is not less than 1:2, so that the ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spiral when the main sealing structure 31 is deployed is 1.5 to 1.8. Figure 4 In the example, the ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spiral when the main sealing structure 31 is deployed is 1.8.

[0088] As described above, the aneurysm occlusion device 30 preferably further includes a distal guide structure 32. The proximal end of the distal guide structure 32 is connected to the distal end of the main occlusion structure 31, meaning the distal guide structure 32 is entirely disposed outside the main occlusion structure 31 and located at the distal end of the main occlusion structure 31. Similarly, the distal guide structure 32 has a spiral-shaped unfolded state and a compressed state for delivery from within the blood vessel to the aneurysm. When the distal guide structure 32 is inside the microcatheter, it is in the compressed state; when the microcatheter is pushed out, it automatically returns to the unfolded state. The spiral of the distal guide structure 32 during unfolding can be a planar spiral (i.e., a two-dimensional spiral) or a three-dimensional spiral. The spiral direction of the distal guide structure 32 can be the same as or different from the spiral direction of the main occlusion structure 31; preferably, the spiral direction of the distal guide structure 32 is the same as the spiral direction of the main occlusion structure 31.

[0089] The distal guide structure 32, when deployed, can have a spiral structure with a uniform or non-uniform outer diameter distribution, such as... Figure 4 The distal guide structure 32 has two regular elliptical spirals. The number of spirals in the distal guide structure 32 when deployed is also set according to the size of the aneurysm, and therefore is not limited to two spirals. For the treatment of small aneurysms, a distal guide structure 32 with fewer spirals can be selected, while for larger aneurysms, a distal guide structure 32 with more spirals can be selected.

[0090] When compressed within the microcatheter, the distal guide structure 32 generally takes the form of a slender linear structure, with the outer diameter of its spiral body being much smaller than the outer diameter of the network tube of the main occlusion structure 31. The distal guide structure 32 serves two purposes: firstly, it guides the main occlusion structure 31 during its initial release, guiding its rotation within the aneurysm cavity and sequentially covering the inner wall of the aneurysm until it is completely released; secondly, after the main occlusion structure 31 is released, the distal guide structure 32 provides internal support, increasing the overall stability of the entire aneurysm occlusion device when filling large aneurysms, making it less susceptible to compression and displacement. Furthermore, due to the small outer diameter of the spiral body of the distal guide structure 32, it is generally more flexible, reducing the impact of the entire aneurysm occlusion device on the aneurysm wall. In addition, the outline shape of the spiral structure of the distal guide structure 32 in its unfolded state, besides… Figure 4 Besides the irregular elliptical spiral structure shown, other regular or irregular spiral structures are also possible, without any particular limitation.

[0091] The distal guide structure 32 can be integrally formed with the main sealing structure 31. For example, it can be manufactured by rotating, winding, compressing, and shaping the same mesh tube, so that the entire mesh tube presents a structure that is slender at the distal end, expanded in the middle, and compressed at the proximal end. Of course, in other embodiments, the distal guide structure 32 can also be separately formed from the main sealing structure 31. That is, after the two are manufactured separately, the distal guide structure 32 is fixed to the distal end of the main sealing structure 31. Compared with separate molding, the integral molding process is simpler and does not require additional connection processing at the distal end of the main sealing structure 31 and the proximal end of the distal guide structure 32.

[0092] Furthermore, the maximum planar height of the aneurysm occlusion device 30 when deployed is not less than 1 / 4 of the maximum outer diameter A of the planar spiral of the main occlusion structure 31 when deployed, and more preferably, the maximum planar height is 1 / 3 to 2 / 3 of the maximum outer diameter A of the planar spiral of the main occlusion structure 31 when deployed. In one specific embodiment, the maximum planar height of the aneurysm occlusion device 30 when deployed is 0.5 times the maximum outer diameter A of the planar spiral of the main occlusion structure 31 when deployed. It should be understood that the maximum planar height of the aneurysm occlusion device 30 when deployed refers to the maximum height of the entire aneurysm occlusion device in the plane perpendicular to the plane of the planar spiral, and its planar height is perpendicular to the plane of the aneurysm neck.

[0093] The distal guide structure 32 has at least one helix, and the outer diameter of the first helix starting from its distal end is the same as the inner diameter of the subsequent helixes, so that the subsequent helixes can cover the preceding helixes. Further, the maximum outer diameter D of the helix of the distal guide structure 32 when deployed is not greater than 1 / 2 of the maximum outer diameter A of the planar helix of the main sealing structure 32 when deployed. For example, in this embodiment, the maximum outer diameter D of the helix of the distal guide structure 32 when deployed is 1 / 2 of the maximum outer diameter A of the planar helix of the main sealing structure 31 when deployed.

[0094] Continue reading Figure 4 Preferably, the proximal end a of the main sealing structure 31 is bound and fixed by a proximal imaging marker, which binds and fixes the proximal braided wire ends together to form a non-invasive proximal end a, avoiding any impact on the tumor wall. Preferably, the distal end b of the distal guiding structure 32 (i.e., the distal end of the entire device) is bound and fixed by a distal imaging marker, which binds and fixes the distal braided wire ends together to form a non-invasive distal end b. The proximal imaging marker and the distal imaging marker can be imaging sleeves.

[0095] In a specific embodiment, such as Figure 4 As shown, the main blocking structure 31 has two generally elliptical planar spirals when deployed, and the distal guide structure 32 has two generally elliptical spirals when deployed. The ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spirals of the main blocking structure 31 when deployed is 1.8. The maximum plane height of the aneurysm blocking device 30 when deployed is 0.5 times the maximum outer diameter A of the planar spirals of the main blocking structure 31 when deployed. The maximum outer diameter D of the spirals of the distal guide structure 32 when deployed is 1 / 2 of the maximum outer diameter A of the planar spirals of the main blocking structure 31 when deployed. This allows the aneurysm blocking device 30 to be suitable for filling long spherical aneurysms. The long axis direction (i.e., the direction of the maximum outer diameter) of the main blocking structure 31 is perpendicular to the plane where the aneurysm neck is located.

[0096] <Example 4>

[0097] The preferred embodiment of the present invention also provides a hemangioma occlusion system, including a microcatheter and the hemangioma occlusion device provided in any embodiment. The hemangioma occlusion device is compressed within the microcatheter and can return to a spiral-shaped unfolded state after being detached from the microcatheter.

[0098] A preferred embodiment of the present invention also provides a hemangioma occlusion treatment device, including a push rod and the hemangioma occlusion device provided in any embodiment, wherein the push rod is detachably connected to the proximal end of the mesh expansion structure of the hemangioma occlusion device.

[0099] The push rod is detachable from the proximal end of the mesh expansion structure. Preferably, the push rod extends tangentially to the spiral line of the planar spiral of the main occlusion structure when deployed, so that the outer surface of the maximum spiral of the main occlusion structure covers the aneurysm neck opening during release. That is, the outer surface of the main occlusion structure is positioned across the neck of the aneurysm, thereby improving the coverage of the aneurysm neck opening, preventing proximal herniation of the main occlusion structure, and ensuring that the proximal end of the main occlusion structure is not located in the middle of the aneurysm neck opening, thus avoiding affecting the healing of the aneurysm neck. The detachment method between the push rod and the main occlusion structure can be any of the existing technologies, such as heating, electrolysis, mechanical methods, or hydrolysis, and is not limited thereto. The function of the push rod is to push the aneurysm occlusion device detach from the microcatheter, realizing the release of the aneurysm occlusion device within the aneurysm.

[0100] The working principle of the hemangioma occlusion device of the present invention will be further described below, with a planar spiral distal guide structure as an example. However, those skilled in the art should know that when the distal guide structure is a three-dimensional spiral, the following method can still be used for operation.

[0101] First, the aneurysm occlusion device is delivered via a microcatheter. Before delivery, the device is inserted into the microcatheter and compressed into a stretched state. This elongates the device into a straight shape, minimizing its radial dimension and allowing delivery within the small-diameter microcatheter. Next, once the distal end of the microcatheter is positioned proximally to the aneurysm, the device is released. During release, it can be pushed distally using a pusher or retracted proximally using the microcatheter, allowing the distal guide structure to be released within the aneurysm. The distal guide structure then rotates and forms a predetermined shape within the aneurysm. Because the distal guide structure is a slender and flexible spiral structure, the friction within the aneurysm is relatively low, making it easy to return to its spiral shape. This allows the distal guide structure to rotate and form a filling plane on the largest plane within the aneurysm. As the aneurysm occlusion device is further advanced, the main occlusion structure begins to release. Guided by the distal guide structure, the main occlusion structure continues to rotate and form on the filling plane formed by the distal guide structure. The outer surface of the distal guide structure connects sequentially with the inner surface of the main occlusion structure, and the outer diameter of the spiral continuously increases until the main occlusion structure is fully deployed. This allows the outer surface of the largest spiral of the aneurysm occlusion device to cover the inner side of the aneurysm neck, ensuring the entire device is stably coiled within the aneurysm, forming a stable and compliant occlusion. Finally, after confirming complete occlusion, the push rod can be electrically disengaged from the main occlusion structure, and the microcatheter and push rod can be withdrawn, completing the embolization.

[0102] The technical solution provided by the embodiments of the present invention has the following advantages:

[0103] (1) The above-mentioned aneurysm closure device can not only form a continuous dense network coverage on the neck of the aneurysm through the side wall of the network tube of the main closure structure, but also adapt to more aneurysm shapes and locations. In particular, the uneven outer diameter of the network tube of the main closure structure can improve the compliance of the aneurysm closure device with irregular aneurysm cavities and improve the molding effect, making the aneurysm closure device particularly suitable for filling irregular aneurysms such as long spherical or flat spherical shapes, and improving the treatment range of the aneurysm closure device.

[0104] (2) The spiral structure of the above-mentioned aneurysm occlusion device can improve the spatial division within the aneurysm cavity, promote turbulence and thrombus formation, promote the formation of thrombi within the aneurysm, and accelerate the embolization of the aneurysm.

[0105] (3) The distal guide structure of the above-mentioned aneurysm closure device is spiral-shaped, so that the distal rivet point is inside the aneurysm cavity and does not directly contact the aneurysm wall, thus reducing the impact of the device on the aneurysm wall; similarly, the proximal rivet point is parallel to the aneurysm wall and can be pressed between the main closure structure and the aneurysm wall, which will not affect the coverage at the aneurysm neck and has good stability.

[0106] (4) The release process of the above-mentioned aneurysm occlusion device is simple, which can reduce the reliance on the doctor's personal aneurysm embolization experience during the operation and reduce the operation time.

[0107] (5) The outer surface of the main sealing structure can be used to cover the aneurysm neck, making the device non-orientable to a certain extent, and the multi-layer dense mesh structure can improve the aneurysm neck coverage rate and reduce the number of instruments required for surgery.

[0108] (6) The aneurysm closure device is located entirely within the aneurysm, which can avoid the use of dual antiplatelet drugs;

[0109] (7) The hemangioma occlusion device gradually fills the lesion through radial dimensions and can reach more lesion locations through a microcatheter with a smaller inner diameter; while improving the coverage of the aneurysm neck, the device increases the internal turbulence effect.

[0110] The above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A hemangioma occlusion device, characterized in that, It includes a main occlusion structure in the form of a mesh tube, the main occlusion structure having a planar spiral unfolded state and a compressed state for delivery from inside the blood vessel to the hemangioma, and the outer diameter of the mesh tube of the main occlusion structure is uneven, so that the outer diameter distribution of the planar spiral is uneven when the main occlusion structure is unfolded; The main sealing structure has a maximum outer diameter and a minimum outer diameter in its planar spiral when it is deployed. The maximum outer diameter corresponds to the major axis direction of the planar spiral, and the major axis direction is parallel or perpendicular to the plane where the aneurysm neck is located. The ratio of the minimum to the maximum diameter of the main sealing structure is not less than 1:2, so that the ratio of the maximum to the minimum outer diameter of the planar spiral when the main sealing structure is unfolded is 1.5 to 1.

8. The maximum planar height of the hemangioma occlusion device when deployed is not less than 1 / 4 of the maximum outer diameter of the planar spiral when the main occlusion structure is deployed; the maximum planar height of the hemangioma occlusion device when deployed is the maximum height of the entire hemangioma occlusion device in the direction perpendicular to the plane where the planar spiral is located, and the planar height is perpendicular to the plane where the aneurysm neck is located.

2. The hemangioma occlusion device according to claim 1, characterized in that, It also includes a distal guide structure disposed outside the main occlusion structure, the proximal end of the distal guide structure being connected to the distal end of the main occlusion structure, the distal guide structure having a spiral unfolded state and a compressed state for delivery from the blood vessel to the aneurysm; the spiral direction of the distal guide structure is the same as the spiral direction of the main occlusion structure.

3. The hemangioma occlusion device according to claim 2, characterized in that, The outer diameter distribution of the spiral when the distal guide structure is deployed may be uniform or non-uniform.

4. The hemangioma occlusion device according to claim 2, characterized in that, The maximum planar height of the hemangioma closure device when deployed is 1 / 3 to 2 / 3 of the maximum outer diameter of the planar spiral when the main closure structure is deployed.

5. The hemangioma occlusion device according to claim 2, characterized in that, The maximum outer diameter of the spiral when the distal guide structure is deployed is not greater than 1 / 2 of the maximum outer diameter of the planar spiral when the main sealing structure is deployed.

6. The hemangioma occlusion device according to claim 2, characterized in that, The remote guiding structure and the main sealing structure are pre-made from the same network tube.

7. The hemangioma occlusion device according to claim 1 or 2, characterized in that, When the main sealing structure is unfolded, it has at least one planar spiral, which is formed by spirally winding a mesh tube, and the mesh tube has a cross-section with different shapes and / or sizes when unfolded.

8. The hemangioma occlusion device according to claim 7, characterized in that, The mesh tube is woven from braided filaments with a diameter of 0.0008in to 0.002in and a number of 48 to 144 filaments. The maximum outer diameter of the mesh tube is 2mm to 8mm.

9. The hemangioma occlusion device according to claim 1 or 2, characterized in that, The maximum outer diameter of the planar spiral when the main sealing structure is deployed is 4mm~32mm.

10. The hemangioma occlusion device according to claim 1 or 2, characterized in that, The proximal end of the hemangioma occlusion device is bound and fixed by a proximal imaging marker, and / or the distal end of the hemangioma occlusion device is bound and fixed by a distal imaging marker.

11. A device for occluding and treating hemangiomas, characterized in that, The device includes a hemangioma occlusion device and a push rod as described in any one of claims 1-10, wherein the push rod is detachably connected to the proximal end of the main occlusion structure of the hemangioma occlusion device; the push rod extends in the tangential direction of the helical line of the planar spiral when the main occlusion structure is unfolded.

12. A hemangioma occlusion system, characterized in that, The device includes a hemangioma occlusion device and a microcatheter as described in any one of claims 1-10, wherein the hemangioma occlusion device is compressed within the microcatheter and can return to an unfolded state after being detached from the microcatheter.

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