Embolic device and embolic system

Abstract

The present application relates to a kind of embolism device and embolism system, embolism system includes push rod and embolism device, the distal end of push rod is releasably connected with the fixed structure of embolism device, embolism device includes the fixed structure and the axial connection of far-end grid body and near-end grid body in sequence, far-end grid body and near-end grid body are made of two ends closed net tube, and far-end grid body and near-end grid body can be relatively twisted;Wherein: embolism device at least has compression state and unfolded state, and can be switched between compression state and unfolded state;So configure, it can reduce the damage to tumor wall, avoid the risk of proximal herniation into tumor blood vessel, and be applicable to different specifications of hemangioma, expand application range.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an embolization device and an embolization system. BACKGROUND

[0002] Intracranial aneurysm is a pathological protrusion of intracranial arterial wall, with an incidence of 5% to 10%. MRA studies show that the incidence of unruptured aneurysm in Chinese adults aged 35 to 75 is about 7.0%. Among them, saccular aneurysm is the most common type of aneurysm, accounting for 80% to 90% of all intracranial aneurysms, and is the most common cause of non-traumatic subarachnoid hemorrhage (SAH). Depending on the severity of the hemorrhage, it can cause permanent neurological deficits or death. Vascular intervention, which can avoid brain tissue and directly reach the lesion with minimal surgical trauma, has become the mainstream method for treating intracranial aneurysms in recent years. There are two main ways of vascular intervention, namely, coil embolization and blood flow guiding device.

[0003] Coil embolization is to release a pre-shaped coil from a catheter into an aneurysm for filling, which causes blood flow in the aneurysm cavity to slow down and stagnate, thereby causing clot formation and excluding further blood flow, thus preventing further expansion of the aneurysm. When embolization is successful, the thrombus may eventually be covered with a layer of endothelial cells, re-forming the internal blood vessel wall. However, not all coil embolization surgeries are successful, and coil embolization can lead to aneurysm recanalization, and additional devices such as auxiliary stents and blood flow guiding devices may need to be implanted. The use of multiple devices increases the operation time, treatment cost and the possibility of adverse events. Moreover, coil embolization is less efficient, requires higher skills and experience from the doctor, and has the risk of herniation of the aneurysm when used alone, and when used in combination with other devices, it increases the risk of ischemic complications.

[0004] The use of blood flow guiding devices has improved the long-term efficacy of large and giant aneurysms, and greatly reduced the use of coils. Computer hemodynamic simulation analysis shows that when the metal coverage rate reaches 30% to 50%, it can significantly reduce the blood flow in the aneurysm cavity. However, the use of blood flow guiding devices makes patients dependent on dual antiplatelet therapy for a long time, and there is a risk of hemorrhagic complications after surgery; at the same time, the use of blood flow guiding devices for bifurcated aneurysms has the risk of blocking the branch vessels. In addition, the use of blood flow guiding devices alone to treat some large aneurysms has a certain risk of delayed rupture.

[0005] There are also some new embolization devices, which are usually made of shape memory material and pre-shaped, delivered through catheter, pushed out from the sheath tube after reaching the specific location, self-expand to the pre-shaped, 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. The 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. The third embolization device is provided, which is woven by double-layer nickel-titanium alloy, and its working principle is similar to that of the first embolization device, but the device has no rivet point at the distal end. The fourth embolization device is provided, which is woven by double-layer memory alloy, and is in a disc shape without restriction. When released in the aneurysm, it will be limited by the aneurysm wall to be in a tulip shape, which can be stable at the lower part of the aneurysm and cover the aneurysm neck, thereby playing a role in reconstructing hemodynamics.

[0006] However, the rivet point design at the distal and proximal ends of the first embolization device makes the device an axisymmetric structure, which has orientation in covering the aneurysm neck, is mainly used for treating bifurcated wide-diameter aneurysms, and is particularly suitable for regular aneurysms. Moreover, if the first embolization device is designed as a single sphere, the device has a long release length, and the friction and extrusion of the device on the aneurysm wall during the release process are large. In addition, the distal rivet point has an impact on the aneurysm wall, which can easily lead to the rupture of the aneurysm wall, the bleeding of the aneurysm, and in some cases, the proximal rivet point can be herniated into the parent artery due to the extrusion of the aneurysm wall, which affects the endothelialization process of the aneurysm neck. In addition, the first embolization device is usually a single sphere or cylinder, which has a large contact area but insufficient support, and has poor long-term stability in the aneurysm cavity, and the device is prone to displacement. The second embolization device is shaped into a three-dimensional mesh structure by multiple sheet-shaped meshes, which is similar to a sphere. Due to the large friction between the three-dimensional mesh structure and the aneurysm wall, the device has poor stability in the aneurysm, and it is not easy to recover to the predetermined shape, which affects the filling effect. Moreover, the device needs to be used with a spring coil, and the operation is complex. The third embolization device has a working principle similar to that of the first embolization device, so it also has the same problems. Although the third embolization device has no distal rivet point, the proximal rivet point makes the aneurysm neck have orientation in covering, and the proximal rivet point can be herniated into the parent artery due to the extrusion of the aneurysm wall, which affects the endothelialization process. The proximal rivet point of the fourth embolization device is also prone to herniation into the parent artery due to the extrusion 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. At the same time, the internal cavity has small resistance to blood flow in the aneurysm, which is not conducive to the formation of thrombus in the aneurysm. SUMMARY

[0007] The embolization device and the embolization system can reduce damage to the tumor wall, avoid the risk of proximal herniation into the tumor-bearing blood vessel, and are suitable for more specifications of hemangioma, thereby expanding the application range.

[0008] To achieve the above object, the present application provides an embolization device for filling hemangioma, which comprises a distal mesh body, a fixing structure and a proximal mesh body connected in sequence in the axial direction, the distal mesh body and the proximal mesh body are both made of a mesh tube with both ends closed, and the distal mesh body and the proximal mesh body can be twisted relative to each other; wherein: the embolization device has at least a compressed state and an expanded state, and can be switched between the compressed state and the expanded state.

[0009] Optionally, after the embolization device is expanded, the distal mesh body is an ellipsoidal structure or a cylindrical structure, the proximal mesh body is an ellipsoidal structure or a cylindrical structure, and the long axis of the distal mesh body and the long axis of the proximal mesh body are both arranged to intersect with the longitudinal axis of the embolization device.

[0010] Optionally, after the embolization device is expanded, the maximum outer diameter of the proximal mesh body is greater than or equal to the total longitudinal height of the embolization device.

[0011] Optionally, after the embolization device is expanded, the maximum outer diameter of the distal mesh body is less than or equal to the maximum outer diameter of the proximal mesh body.

[0012] Optionally, after the embolization device is expanded, the maximum outer diameter of the distal mesh body is greater than or equal to 1 / 2 of the maximum outer diameter of the proximal mesh body.

[0013] Optionally, after the embolization device is expanded, the maximum outer diameter of the proximal mesh body is 3mm-25mm.

[0014] Optionally, each mesh tube is a woven body, the wire diameter of the woven wire in the woven body is 0.0008in-0.002in, and the number of the woven wires is 48-144.

[0015] Optionally, after the embolization device is expanded, the longitudinal height of the distal mesh body is 1 / 3-1 / 2 of the total longitudinal height of the embolization device.

[0016] Optionally, one end of the fixing structure is fixedly connected with the mesh surface of the proximal mesh body, and the other end is fixedly connected with the mesh surface of the distal mesh body.

[0017] Optionally, the fixing structure can be developed, and / or the fixing structure is an elastic structure.

[0018] To achieve the above object, the application further provides an embolization system, which comprises a push rod and the embolization device, and the distal end of the push rod is detachably connected with the fixing structure of the embolization device.

[0019] Compared with the prior art, the embolization device and the embolization system have at least one of the following advantages:

[0020] Firstly, the embolization device has the intermediate fixing structure, so that the distal end mesh body can recover to the expanded state before the proximal end mesh body in the releasing process, and is not affected by the unreleased proximal end mesh body, thereby effectively shortening the releasing length of the entire embolization device; in this way, on the one hand, the embolization device reduces the extrusion and friction of the hemangioma in the releasing process, improves the safety of the operation, and on the other hand, reduces the restriction of the length-diameter ratio of the hemangioma on the selection of the embolization device, so that the embolization device can be applied to larger hemangioma sizes and different positions of the hemangioma, and in addition, the relative torsion between the proximal end mesh body and the distal end mesh body can be generated, so that the embolization device can be applied to different shapes of hemangioma;

[0021] Secondly, the distal end mesh body is composed of the mesh tube with both ends closed, so that the entire distal end mesh body has no rivet points protruding from the mesh surface, and the entire distal end is a uniform dense mesh surface, so that the distal end mesh body can effectively disperse the force acting on the tumor wall after contacting the tumor wall, reduce the damage of the embolization device to the hemangioma, and reduce the risk of rupture of the hemangioma, and in the releasing process of the proximal end mesh body, the distal end mesh body can also buffer the force of the entire embolization device acting on the hemangioma, further reducing the risk of rupture of the hemangioma;

[0022] Thirdly, the proximal end mesh body is also composed of the mesh tube with both ends closed, so that the entire proximal end mesh body has no rivet points protruding from the mesh surface, and the entire proximal end is a uniform dense mesh surface, so that the proximal end dense mesh surface can effectively cover the tumor neck, reduce the blood flow into or out of the hemangioma, promote thrombosis, and further promote the healing of the hemangioma and the endothelialization process at the tumor neck;

[0023] Fourthly, the releasing of the embolization device is simpler, which can reduce the dependence on the personal experience of the doctor in the operation process, and reduce the operation time; in addition, the proximal end mesh body and the distal end mesh body form a multi-layer dense mesh structure in the tumor cavity, which can improve the embolization density, reduce the number of instruments required in the operation, increase the internal turbulence effect while improving the coverage of the tumor neck, promote the formation of thrombus in the tumor, and accelerate the embolization of the hemangioma; in addition, the embolization device is completely located in the hemangioma, which can avoid the use of double anti-platelet drugs. BRIEF DESCRIPTION OF DRAWINGS

[0024] The method of implementing the present application and the features, properties and advantages of the related embodiments will be described in conjunction with the following drawings, in which:

[0025] Figure 1 is a front view of the embolization device of the preferred embodiment one of the present application;

[0026] Figure 2 is a top view of the embolization device of the preferred embodiment one of the present application, the top view is from the distal end to the proximal end;

[0027] Figure 3 is a state diagram of the embolization device of the preferred embodiment one of the present application in the releasing process;

[0028] Figure 4 is a state diagram of the embolization device of the preferred embodiment one of the present application in the complete releasing process in the aneurysm;

[0029] Figure 5 is a cross-sectional view of the embolization device of the preferred embodiment one of the present application, in which the proximal mesh surface covers the aneurysm neck;

[0030] Figure 6 is a front view of the embolization device of the preferred embodiment two of the present application;

[0031] Figure 7 is a front view of the embolization device of the preferred embodiment three of the present application.

[0032]

The following is the description of the reference signs

[0033] 10-embolization device; 11-proximal mesh body; 12-distal mesh body; 13-fixing structure; 21-push rod; 31-microcatheter; 40-aneurysm; 41-aneurysm neck; 50-aneurysm-carrying artery; L-longitudinal height of the embolization device; D1-maximum outer diameter of the distal mesh body; D2-maximum outer diameter of the proximal mesh body. DETAILED DESCRIPTION

[0034] In order to make the purpose, advantages and features of the present application more clear, the following will make further detailed description of the present application in conjunction with the drawings. It should be noted that the drawings are all very simplified and use non-precise proportions, only to facilitate and clearly assist the purpose of explaining the embodiments of the present application.

[0035] As used in this specification, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense of "and / or" unless the content clearly dictates otherwise. As used in this specification, the term "plurality" is generally employed in its sense of "two or more" unless the content clearly dictates otherwise. As used in this specification, the term "number of" is generally employed in its sense of "an unspecified quantity of" unless the content clearly dictates otherwise. As used in this specification, the terms "proximal" and "distal" refer to the position of the embolization device and / or portions of the embolization device relative to an operator along a longitudinal axis of the embolization device. Generally, "proximal" refers to the end closer to the operator and "distal" generally refers to the end further from the operator. In this context, "longitudinal" refers to a direction perpendicular to a cross-section of a neck of the aneurysm, i.e., perpendicular to a cross-section of the aneurysm cavity; "transverse" refers to a direction parallel to a cross-section of the neck of the aneurysm, i.e., parallel to a cross-section of the aneurysm cavity.

[0036] The core of the present application is to disclose an embolization device, which is mainly used for treating intracranial saccular aneurysms, including bifurcated aneurysms and sidewall aneurysms. However, it should be understood that the embolization device disclosed in the present application is not limited to aneurysms, but can also be an aneurysm occurring in other blood vessels.

[0037] The embolization device disclosed in the present application is a multi-layer dense mesh structure, which can achieve occlusion of the aneurysm neck in the aneurysm, does not enter the parent vessel, and does not need to be taken for a long time. The proximal end of the embolization device disclosed in the present application is a uniform dense mesh surface that can cover the aneurysm neck, which plays a role of disturbing flow, reduces the impact of blood flow on the aneurysm sac, promotes the formation of thrombus in the aneurysm, and thus achieves the purpose of embolization of the aneurysm. The embolization device disclosed in the present application can effectively shorten the release length, reduce the friction and extrusion of the aneurysm wall during the release process, and improve the safety of the operation. At the same time, the distal end and the side in contact with the aneurysm cavity are also free of rivets, which can further reduce the damage to the aneurysm.

[0038] The embolization device disclosed in the present application can be delivered through a microcatheter, has at least a compressed state and an expanded state, and can switch between the compressed state and the expanded state. Generally, the embolization device is in a compressed state in the microcatheter and returns to an expanded state after being pushed out of the microcatheter.

[0039] The present application will be described in more detail by reference to the accompanying drawings and preferred embodiments. In the case of no conflict, the following embodiments and features in the embodiments can be supplemented or combined with each other. For the sake of brevity, it is assumed in the following description that the aneurysm is an intracranial aneurysm, and those skilled in the art should be able to modify the following description to be used in cases other than intracranial aneurysms with appropriate modifications in details.

[0040] <Example 1>

[0041] A preferred embodiment of the present invention provides an embolization device 10, such as... Figures 1 to 5 As shown. The embolization device 10 includes a proximal mesh body 11, a fixing structure 13, and a distal mesh body 12 connected axially in sequence; both the distal mesh body 12 and the proximal mesh body 11 are composed of mesh tubes closed at both ends, so that the entire embolization device 10 has no rivets at either the distal or proximal end, avoiding many problems caused by the presence of proximal and distal rivets. Here, the rivet can generally be understood as the binding end of multiple braided wires. In the prior art, the mesh braid usually has proximal and distal binding portions, which are end structures formed by the gathering and binding of braided wires together. These binding portions of braided wires generally protrude outwards from the braid to form sharp points (i.e., rivets), which can easily impact and compress the aneurysm wall, causing the aneurysm to rupture.

[0042] Therefore, the embolization device 10 of this embodiment does not have a concave structure for hiding the rivet point. It can not only increase the contact area and improve stability by contacting the top of the aneurysm through the dense mesh surface at the distal end, and reduce the impact on the aneurysm wall, but also increase the metal coverage of the aneurysm neck by covering it with the dense mesh surface at the proximal end, while avoiding the problem of the proximal rivet point herniating into the aneurysm-bearing vessel. It should also be understood that the mesh tube closed at both ends refers to the use of a centripetal weaving method, so that the braided filaments are in a state of central concentration. For example, the proximal mesh surface of the proximal mesh body 11 is formed by the braided filaments at the closed end of the mesh tube converging towards the center to form a uniform and dense mesh surface. Similarly, the distal mesh surface of the distal mesh body 12 is also formed by the braided filaments at the closed end of the mesh tube converging towards the center, and also has a uniform and dense mesh surface. More specifically, since the embolization device 10 has no rivets at either the proximal or distal end, it reduces damage to the aneurysm wall, prevents the distal rivet from impacting the aneurysm wall, reduces the risk of aneurysm wall rupture, and avoids the problem of the proximal rivet being squeezed by the aneurysm wall and easily herniating into the parent artery, thus avoiding the impact on the endothelialization process. At the same time, the coverage of the aneurysm neck of the device does not have orientation problems, and it is applicable to both regular and irregular aneurysms, as well as apical or lateral wall aneurysms.

[0043] In addition, the setting of the fixing structure 13 enables the relative torsion between the distal mesh 12 and the proximal mesh 11, so that the two meshes can be coaxial or non-coaxial, thereby not being limited by the orientation of the aneurysm neck and having a wider application range. It should also be understood that the fixing structure 13 does not overlap the proximal mesh 11 and the distal mesh 12 in the longitudinal direction, i.e. the fixing structure 13 is arranged between the proximal mesh 11 and the distal mesh 12, thereby fixing the two meshes and enabling the relative torsion of the two meshes, the torsion angle can be larger, and the aneurysm of different shapes can be applied. Moreover, the size of the fixing structure 13 is much smaller than the size of any mesh, which provides elasticity while ensuring a certain connection strength, and the size of the fixing structure 13 can be set by the person skilled in the art as needed, for example, the fixing structure 13 can be arranged to have a length of about 0.5mm-2.0mm.

[0044] The fixing structure 13 is usually fixed by glue bonding with the mesh, one end of the fixing structure 13 is glued and fixed with the distal mesh surface of the proximal mesh 11, and the other end of the fixing structure 13 is glued and fixed with the proximal mesh surface of the distal mesh 12. The structure of the fixing structure 13 is not limited in the present application, which can be an elastic tube, a spring, a spring, etc. Further, the fixing structure 13 can be developed, such as a developed ring or a developed spring.

[0045] Further, the preferred embodiment of the present application also provides an embolization system, which comprises a pushing rod 21 and an embolization device 10, the distal end of the pushing rod 21 is detachably connected with the fixing structure 13. Therefore, the embolization device 10 can be delivered through the microcatheter 31 and delivered into the aneurysm through the pushing rod 21, thereby releasing and recovering the embolization device. It can be released and recovered multiple times, which reduces the operation difficulty, effectively embolizes the aneurysm, avoids the occlusion of the aneurysm and the branch, and also effectively avoids the displacement of the device, reduces the risk of displacement after the aneurysm is filled, and can treat aneurysms of different positions, different shapes and different sizes.

[0046] The pushing rod 21 can be detached from the fixing structure 13. The distal end of the pushing rod 21 has a detachment area, which can be detached after the embolization device 10 reaches a specific position, and the detachment mode between the pushing rod 21 and the fixing structure 13 can adopt the existing technology of heating, electrolysis, mechanical or hydrolysis, which is not limited. In the case of unsatisfactory release of the device, it can be repositioned and released again after being recovered.

[0047] Reference Figure 3During delivery, the microcatheter 31 is first inserted into the carrier artery 50, and the distal end of the microcatheter 31 is aligned with the aneurysm 40. The embolization device 10 is then delivered through the microcatheter 31, and the push rod 21 pushes the embolization device 10 out of the distal end of the microcatheter 31. During release, the distal mesh 12 is pushed out into the aneurysm cavity first, followed by the proximal mesh 11. After the embolization device 10 is completely released, the push rod 21 is separated from the fixation structure 13, and finally, both the push rod 21 and the microcatheter 31 are withdrawn from the body to complete the embolization.

[0048] Figure 4 and Figure 5 This describes the state where the embolization device 10 is packed within the aneurysm 40. For example... Figure 4 and Figure 5 As shown, the entire embolization device 10 completely covers the aneurysm neck 41 through the proximal mesh surface of the proximal mesh body 11, providing a continuous, high metal coverage and high mesh density coverage surface at the aneurysm neck 41, resulting in good occlusion. Furthermore, the proximal mesh body 11 and the distal mesh body 12 form a multi-layered dense mesh within the aneurysm cavity, providing good flow disturbance and accelerating thrombus formation and endothelialization within the aneurysm. In addition, the embolization device 10 has a small axial length after release, making it suitable for larger aneurysms.

[0049] The present invention does not impose any particular limitation on the shape of the proximal mesh 11 and the distal mesh 12 after unfolding, as long as the mesh surface is smooth and without protrusions. It is understood that the shape of the proximal mesh 11 and the distal mesh 12 after unfolding includes, but is not limited to, ellipsoidal or cylindrical shapes. Preferably, the proximal mesh 11 and the distal mesh 12 are configured with an unfolded shape in which the lateral dimension is larger than the longitudinal dimension, in order to be suitable for the occlusion of larger aneurysms. As in this embodiment, after the embolization device 10 is unfolded, both the distal mesh 12 and the proximal mesh 11 are ellipsoidal structures, and the length of the major axis of each ellipsoidal structure is the lateral dimension (i.e., the maximum outer diameter), and the length of the minor axis is the longitudinal dimension (i.e., the longitudinal height).

[0050] In some embodiments, after the embolization device 10 is deployed, the maximum outer diameter D1 of the distal mesh 12 is equal to the maximum outer diameter D2 of the proximal mesh 11, or the maximum outer diameter D1 of the distal mesh 12 is smaller than the maximum outer diameter D2 of the proximal mesh 11. In this case, it can be applied to larger aneurysms. Preferably, the maximum outer diameter D1 of the distal mesh 12 is greater than or equal to half the maximum outer diameter of the proximal mesh 11 to ensure sufficient support and guarantee the stability of the entire device. In this embodiment, as... Figure 1 As shown, the maximum outer diameter D1 of the distal mesh 12 is equal to the maximum outer diameter D2 of the proximal mesh 11, and the entire embolization device 10 can be applied to aneurysms of smaller size.

[0051] According to the clinical requirements, the maximum outer diameter D2 of the proximal mesh body 11 after the embolization device 10 is deployed is generally 3mm-25mm, so that the embolization device 10 can be suitable for aneurysms of different specifications. In addition, each of the mesh tubes is generally woven by braided wires, preferably, the wire diameter of the braided wires is 0.0008in-0.002in, and the number of the braided wires is 48-144, so as to form a relatively dense mesh, and the packing effect is better. Any mesh body can be formed by the mesh tube in a mold, and then two mesh bodies are fixedly connected by the fixing structure 13.

[0052] In some embodiments, the total longitudinal height L of the embolization device 10 after the embolization device 10 is deployed is less than or equal to the maximum outer diameter D2 of the proximal mesh body 11. Preferably, the total longitudinal height L of the embolization device 10 is less than the maximum outer diameter D2 of the proximal mesh body 11, so as to be suitable for aneurysms with a larger length-diameter ratio. In the present embodiment, as shown in Figure 1 , the total longitudinal height L of the embolization device 10 is equal to the maximum outer diameter D2 of the proximal mesh body 11.

[0053] In some embodiments, the longitudinal height of the distal mesh body 12 after the embolization device 10 is deployed is 1 / 3-1 / 2 of the total longitudinal height L of the embolization device 10, that is, the distal mesh body 12 cannot be too high, otherwise the release length will be increased, the safety of the operation will be reduced, and it is not conducive to adapting to wide-necked aneurysms with a larger length-diameter ratio. Moreover, such a setting is also conducive to increasing the transverse size of the proximal mesh body 12 to increase the coverage of the aneurysm neck.

[0054] As shown in Figure 1 , in the present embodiment, the longitudinal height of the distal mesh body 12 after the embolization device 10 is deployed is 1 / 2 of the total longitudinal height L of the embolization device 10.

[0055] Further, the mesh can be woven from woven filaments of elastic or super-elastic material. For example, the filaments can be woven from a shape memory material, including one or more of a shape memory metal material, such as a nickel-titanium (Ni-Ti) alloy, a nickel-titanium-cobalt alloy (Ni-Ti-Co), a double-layer composite metal filament (Ni-Ti@Pt), and the like; a shape memory polymer material, such as one or more of polydioxanone (PDO), poly(lactide-co-ε-caprolactone) (PLC), polyurethane (PU), poly (norbornene) amorphous polymer, and the like; a shape memory material mixed with a metal filament (Pt, Pt-Ir, and the like) having good radiopacity; or a composite filament (DFT) of a shape memory material and a radiopaque material. The composite filament (DFT) includes a core filament and a sleeve that covers the core filament, and the core filament includes one or more of platinum, iridium, gold, silver, tantalum, tungsten, and alloys thereof, and the sleeve includes one or more of a nickel-titanium alloy, nitinol, stainless steel, a cobalt-chromium alloy, a nickel-cobalt alloy, and the like. Thus, the mesh material allows the device to be deformed to a low-profile configuration for constraining within the microcatheter and then to recover to a preset deployed configuration upon release from the microcatheter. In other embodiments, the mesh can be formed from other suitable self-forming materials that are capable of recovering to a desired shape upon release from the microcatheter 31.

[0056] <Embodiment Two>

[0057] In this embodiment, as shown in FIG. 2, the distal mesh body 12 is in a cylindrical structure after the embolization device 10 is deployed, and the proximal mesh body 11 is still in an ellipsoidal structure. The following description mainly focuses on the differences from Embodiment One, and the same parts are referred to Embodiment One. Figure 6

[0058] In this embodiment, the maximum outer diameter D1 of the distal mesh body 12 is 2 / 3 of the maximum outer diameter D2 of the proximal mesh body 11 after the embolization device 10 is deployed, while the maximum outer diameter D1 of the distal mesh body 12 is equal to the maximum outer diameter D2 of the proximal mesh body 11 in Embodiment One. In addition, the total axial height L of the embolization device 10 in this embodiment is equal to the maximum outer diameter D2 of the proximal mesh body 11, which is the same as Embodiment One. In addition, the longitudinal height of the distal mesh body 12 is 2 / 5 of the total longitudinal height L of the embolization device 10 after the embolization device 10 is deployed in this embodiment, while the longitudinal height of the distal mesh body 12 is 1 / 2 of the total longitudinal height L of the embolization device 10 in Embodiment One.

[0059] It should be understood that the embolization device 10 in this embodiment can effectively shorten the release length in the axial direction while ensuring that the proximal mesh surface covers the aneurysm neck, and the transverse size of the proximal mesh surface is larger, which can better cover the aneurysm neck, maintain the stability of the device, and be more suitable for wide-necked aneurysms.​

[0060] <Embodiment Three>

[0061] In this embodiment, as shown in the figure, the distal mesh body 12 is still an ellipsoid structure after the embolization device 10 is deployed, while the proximal mesh body 11 is a cylindrical structure. The following mainly describes the differences from Embodiment One, and the same parts are referred to Embodiment One. Figure 7

[0062] In this embodiment, the maximum outer diameter D1 of the distal mesh body 12 is 1 / 2 of the maximum outer diameter D2 of the proximal mesh body 11 after the embolization device 10 is deployed, while the maximum outer diameter D1 of the distal mesh body 12 is equal to the maximum outer diameter D2 of the proximal mesh body 11 in Embodiment One. In addition, the total axial length L of the embolization device 10 after being deployed is equal to the outer diameter D2 of the proximal mesh body 11, which is the same as Embodiment One. In addition, the longitudinal height of the distal mesh body 12 is 1 / 3 of the total longitudinal height L of the embolization device after the embolization device 10 is deployed, while the longitudinal height of the distal mesh body 12 is 1 / 2 of the total longitudinal height L of the embolization device 10 in Embodiment One.

[0063] It can be understood that the embolization device 10 of this embodiment can effectively shorten the release length of the device in the axial direction while ensuring that the proximal end surface covers the aneurysm neck, and the transverse size of the proximal mesh surface is larger, which can better cover the aneurysm neck, maintain the stability of the device, and be more suitable for larger aneurysms.

[0064] In other embodiments, the proximal mesh body 11 and the distal mesh body 12 can also be cylindrical structures at the same time.

[0065] In summary, the embolization device disclosed in the present application can shorten the release length of the entire embolization device due to the presence of the intermediate fixed structure, which not only reduces the extrusion and friction of the embolization device on the aneurysm, but also reduces the restriction of the length-diameter ratio of the aneurysm on the selection of the embolization device, so that it can be applied to larger aneurysm sizes. In addition, the distal mesh body can also buffer the force of the device on the aneurysm during the proximal release process. At the same time, the distal end has no rivet points but a uniform and dense mesh surface, and the center of which is arranged centripetally from the closed end of the mesh tube, which can effectively disperse the force on the aneurysm wall after contacting the aneurysm wall, reduce the damage of the embolization device to the aneurysm, and reduce the risk of aneurysm rupture. The proximal end also has no rivet points, so that the proximal end surface is a nearly horizontal and uniform dense mesh surface, which can effectively cover the aneurysm neck and promote the process of endothelialization at the aneurysm neck.

[0066] ​It should be understood that the shortening of the release length of the embolization device makes the embolization device not only suitable for bifurcated aneurysms (i.e. top aneurysms), but also suitable for side wall aneurysms. It should be further understood that the releasable connection between the push rod and the intermediate fixing structure of the embolization device solves the problem of the existing embolization device in which the proximal end is provided with a rivet point for connecting the push rod, eliminates the protruding rivet point at the proximal end of the device, and reduces the influence of the device on the blood flow in the parent artery. It should be further understood that the proximal end of the embolization device can be an ellipsoidal or cylindrical structure, and the most proximal surface is formed by the centripetal arrangement of the closed ends of the mesh tubes, and the push rod can pass through the central circular hole and be connected with the fixing structure, so that the proximal surface is a nearly horizontal dense mesh surface without recesses and protrusions, and is uniform and dense, which can effectively cover the aneurysm neck, reduce the blood flow into or out of the aneurysm, promote thrombus formation, and further promote the healing of the aneurysm.

[0067] In addition to the above advantages, the release of the embolization device disclosed in the present application is simpler, which can reduce the dependence of the doctor's personal aneurysm embolization experience during the operation, and reduce the operation time. In addition, the composite structure of the ellipsoidal structure and / or the cylindrical structure makes the intratumoral shaping more stable, and the multi-layer dense mesh structure can increase the embolization density, reduce the number of instruments required for the operation, and increase the intratumoral turbulence while improving the coverage of the aneurysm neck, which can promote the formation of thrombus in the aneurysm and accelerate the embolization of the aneurysm. In addition, the embolization device is completely located in the aneurysm, which can avoid the use of double anti-platelet drugs. Furthermore, in the expanded state, the distal end is in the form of an ellipsoid or a cylinder, and the most distal end can be in contact with the aneurysm top, which ensures that the device stably exists in the aneurysm without displacement, and has good stability.

[0068] The above description is only a description of the preferred embodiments of the present application, and does not limit the scope of the present application in any way. Any modification or modification of the present application made by a person skilled in the art based on the above disclosure is within the scope of the present application.

Claims

1. An embolization device for filling hemangiomas, characterized in that, The device comprises a distal mesh body, a fixing structure, and a proximal mesh body connected axially in sequence. The fixing structure is an elastic structure used for a detachable connection with the distal end of a push rod. Both the distal and proximal mesh bodies are made of mesh tubes closed at both ends. The mesh tubes are woven in a centripetal manner, causing the braided filaments to be centrally concentrated. The fixing structure allows the distal and proximal mesh bodies to twist relative to each other. The embolization device has at least a compressed state and an extended state, and can switch between the compressed and extended states. After the embolization device is extended, the longitudinal height of the distal mesh body is 1 / 3 to 1 / 2 of the total longitudinal height of the embolization device.

2. The embolization device according to claim 1, characterized in that, After the embolization device is deployed, the distal and proximal meshes are configured such that their lateral dimensions are greater than their longitudinal dimensions.

3. The embolization device according to claim 2, characterized in that, The distal grid body is an ellipsoidal or cylindrical structure, and the proximal grid body is an ellipsoidal or cylindrical structure.

4. The embolization device according to claim 1 or 2, characterized in that, After the embolization device is deployed, the maximum outer diameter of the proximal grid body is greater than or equal to the total longitudinal height of the embolization device.

5. The embolization device according to claim 1 or 2, characterized in that, After the embolization device is deployed, the maximum outer diameter of the distal mesh is less than or equal to the maximum outer diameter of the proximal mesh.

6. The embolization device according to claim 5, characterized in that, After the embolization device is deployed, the maximum outer diameter of the distal mesh is greater than or equal to 1 / 2 of the maximum outer diameter of the proximal mesh.

7. The embolization device according to claim 5, characterized in that, After the embolization device is deployed, the maximum outer diameter of the proximal mesh is 3mm to 25mm.

8. The embolization device according to claim 7, characterized in that, Each of the aforementioned mesh tubes is a braided body, wherein the diameter of the braided filaments in the braided body is 0.0008in to 0.002in, and the number of braided filaments is 48 to 144.

9. The embolization device according to claim 1 or 2, characterized in that, One end of the fixed structure is fixedly connected to the mesh surface of the near-end mesh body, and the other end is fixedly connected to the mesh surface of the far-end mesh body.

10. The embolization device according to claim 9, characterized in that, The fixed structure is capable of development.

11. An embolization system, characterized in that, It includes a push rod and an embolization device as described in any one of claims 1-10, wherein the distal end of the push rod is detachably connected to the fixing structure of the embolization device.

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