Embolic device

Abstract

The present application relates to a kind of embolism devices, made of tubular mesh body, for plugging target cavity, the embolism device has unfolded state and compressed state, and can be switched between unfolded state and compressed state;The embolism device includes the proximal mesh body, intermediate mesh body and distal mesh body connected in turn along its own axis;The proximal mesh body and distal mesh body form spiral structure when unfolded state;The intermediate mesh body forms the plane arc structure around the length of target cavity not more than a circle when unfolded state, and is used to cover the opening of target cavity.The present application can realize the plugging of target cavity, and form stable in target cavity, easy to realize the recovery of preform shape, also easy to realize the plugging of target cavity opening, and the damage to cavity wall is small, the difficulty of operation is low, and the scope of application is wide.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an embolization device for occluding a target cavity (e.g., a vascular tumor). BACKGROUND

[0002] An intracranial aneurysm is a pathological protrusion of the intracranial arterial 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 of an aneurysm is to completely isolate the aneurysm from the blood circulation through treatment means. Current treatment means 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 treatments mainly include the following:

[0003] 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 shapes of aneurysms are various, and incomplete coil filling may lead to aneurysm recanalization, and excessive filling may lead to intraoperative rupture of aneurysms, requiring high skills and experience of doctors. Moreover, coil filling needs multiple repeated filling, and the embolization efficiency is low, and in some cases, stents, balloons and microcatheters 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] As a major breakthrough in the endovascular treatment of intracranial aneurysms, the flow diverter brings a new method for the treatment of complex aneurysms, and its treatment principle is to place a dense mesh stent in the parent artery, and after the reconstruction of the lumen of the lesion blood vessel, the lumen surface of the blood vessel is reshaped through the neointima of the tumor neck surface. The application of the flow diverter 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 blood flow in the aneurysm lumen can be significantly reduced, and the cure rate is high. However, the application of the flow diverter makes the patient rely on double antiplatelet therapy for a long time, and there is a risk of hemorrhagic complications after the operation. In addition, there is a certain risk of delayed rupture after treating some large aneurysms.

[0005] There are also some new disposable 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 position, self-expanding to the initial predetermined shape, and then achieving the purpose of occluding aneurysm. There are various embolization devices: the first kind of embolization device is a spherical or cylindrical dense mesh device with rivet points at both ends, which expands in the aneurysm cavity, covers the aneurysm neck through the proximal dense mesh to achieve the treatment of aneurysm; the second kind of embolization device is composed of a visible wire and a peripheral self-expanding memory alloy to form a three-dimensional mesh structure, which 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 kind of embolization device is woven by double-layer nickel-titanium alloy; and the fourth kind of embolization device is woven by double-layer memory alloy, which is disc-shaped under no restriction, and will be tulip-shaped when released in the aneurysm, which can be stable at the lower part of the aneurysm and cover the aneurysm neck, thereby playing the role of reconstructing hemodynamics. However, the first kind of embolization device has a symmetrical structure due to the design of rivet points at both ends, which makes the coverage of the aneurysm neck have orientation, is mainly used for treating bifurcated wide-diameter aneurysm, and is particularly suitable for regular aneurysm; moreover, the design of rivet points at the distal end of the first kind of embolization device has an impact on the aneurysm wall, which easily leads to aneurysm rupture and aneurysm bleeding; and in some cases, the proximal rivet point of the first kind of embolization device will be herniated into the parent artery due to the extrusion of the aneurysm wall, affecting the endothelialization process of the aneurysm neck; in addition, the first kind of 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 it is easy to shift. The second kind of embolization device is shaped into a three-dimensional mesh structure by multiple sheet-shaped meshes, which is similar to a spherical shape, and 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 it needs to be used with a spring coil, which is complicated to operate. The third kind of embolization device has basically the same working principle as the first kind of embolization device, so it also has the same problems as the first kind of embolization device. And the proximal rivet point of the fourth kind of embolization device is also prone to herniation into the parent artery due to the extrusion of the aneurysm wall, which is suitable for top aneurysm, and the device position needs to be repeatedly adjusted and placed, otherwise it will affect the stability of the device in the aneurysm, therefore, the filling efficiency is low. SUMMARY

[0006] The purpose of the present application is to provide an embolization device for achieving the occlusion treatment of target cavities such as aneurysm, which does not need to fill the entire target cavity, not only has better stability in the target cavity, but also is easier to recover to the preformed shape, easier to achieve the occlusion of the opening of the target cavity, less damage to the cavity wall, reduces the risk of rupture of the target cavity, reduces the complexity of the entire embolization device, reduces the difficulty of surgical operation, and has a wider range of applications.

[0007] To achieve the above at least one object, the present application provides an embolization device made of tubular mesh bodies and used for plugging a target cavity, the embolization device having an expanded state and a compressed state and being capable of switching between the expanded state and the compressed state;

[0008] The embolization device comprises a proximal mesh body, a middle mesh body and a distal mesh body connected in sequence along an own axis; the proximal mesh body and the distal mesh body each form a spiral structure in the expanded state; the middle mesh body forms a planar arc structure around the target cavity with a length of no more than one turn in the expanded state and is used for covering an opening of the target cavity.

[0009] In an embodiment, in the expanded state, the middle mesh body is not in the same plane as the proximal mesh body and the distal mesh body, and the proximal mesh body and the distal mesh body are arranged on the same side or different sides of the plane where the middle mesh body is located.

[0010] In an embodiment, the distal mesh body forms a spiral structure of no more than one turn in the expanded state, and / or the proximal mesh body forms a spiral structure of no more than one turn in the expanded state.

[0011] In an embodiment, the distal mesh body forms a spiral structure of 1 / 2 turn to 1 turn in the expanded state, and / or the proximal mesh body forms a spiral structure of 1 / 2 turn to 1 turn in the expanded state.

[0012] In an embodiment, the middle mesh body has a length of 1 / 2 turn to 1 turn around the target cavity in the expanded state.

[0013] In an embodiment, the middle mesh body has a cross-sectional diameter of no less than 1 / 4 of the maximum outer diameter of the entire embolization device in the expanded state.

[0014] In an embodiment, the middle mesh body has a cross-sectional diameter of 1 / 3 to 2 / 3 of the maximum outer diameter of the entire embolization device in the expanded state.

[0015] In an embodiment, the embolization device is an axial symmetric structure in the expanded state, and the proximal mesh body and the distal mesh body are symmetrically arranged about a central axis of the middle mesh body, the central axis being used for passing through the opening of the target cavity.

[0016] In an embodiment, in the expanded state, the cross-sectional diameter of the embolization device first increases and then decreases from the proximal end to the distal end, or the cross-sectional diameter of the embolization device repeatedly increases and then decreases from the proximal end to the distal end.

[0017] In an embodiment, the embolization device is integrally woven by a woven wire.

[0018] In an embodiment, the material of the woven wire comprises a shape memory material and / or a metal developing material, the wire diameter of the woven wire is 0.0008in-0.002in, and the total number of the woven wire is 48-144.

[0019] In an embodiment, all the woven wires at the distal end of the embolization device are fixed by a distal end connector, all the woven wires at the proximal end of the embolization device are fixed by a proximal end connector, and the distal end connector and / or the proximal end connector is made of a metal developing material.

[0020] In the embolization device provided by the present application, the embolization device is made of a tubular mesh body, has an expanded state and a compressed state, and can switch between the expanded state and the compressed state; the embolization device comprises a proximal mesh body, a middle mesh body and a distal mesh body connected in sequence along the axis thereof; the proximal mesh body and the distal mesh body each form a spiral structure in the expanded state; the middle mesh body forms a planar arc structure around the target cavity with a length of not more than one turn in the expanded state, and is used to cover the opening of the target cavity. Taking hemangioma as an example, when configured in this way, the present application can realize the occlusion treatment of hemangioma, and at least one of the following advantages can be achieved:

[0021] (1) The spiral structure formed by the above proximal mesh body can make the proximal end of the embolization device buckle inward or parallel to (including tangent to) the tumor wall, reducing the damage or impact of the proximal end of the embolization device on the tumor wall; at the same time, the spiral structure formed by the above distal mesh body can make the distal end of the embolization device buckle inward or parallel to (including tangent to) the tumor wall, reducing the damage or impact of the distal end of the embolization device on the tumor wall;

[0022] (2) The above middle mesh body fills in the tumor according to the preformed shape under the guidance of the distal mesh body, and finally the outer mesh surface of the middle mesh body covers the inside of the tumor neck, forming a continuous dense mesh surface with a spoiler effect, reducing the impact of blood flow on the hemangioma, slowing down the flow rate in the tumor cavity, promoting thrombus formation, and finally realizing the occlusion of hemangioma;

[0023] (3) Since the above intermediate mesh body forms a planar arc structure around the aneurysm (target cavity) with a length of no more than one turn when it is unfolded, the rotation length and rotation times of the intermediate mesh body in the aneurysm cavity are reduced while ensuring that the intermediate mesh body can provide sufficient lateral mesh surface to cover the aneurysm neck, which can effectively reduce the frictional impact of the embolization device on the aneurysm wall, reduce the friction between the embolization device and the aneurysm wall, make the embolization device more stable in the aneurysm and easier to restore to the preformed shape, ensure the filling effect, and make the release process of the entire embolization device simple, which can reduce the dependence on the personal embolization experience of the doctor during the operation, reduce the operation time, improve the operation efficiency, and at the same time, the embolization device can fill various aneurysms of different shapes and / or sizes, and has a wide range of applications. BRIEF DESCRIPTION OF DRAWINGS

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings in the following description are only some embodiments of the present application, and for those skilled in the art, other drawings can also be obtained from these drawings without creative labor.

[0025] Figure 1 is a view of the embolization device according to preferred embodiment one in an unfolded state;

[0026] Figure 2 is a view of the embolization device according to preferred embodiment one in an unfolded state filling an aneurysm;

[0027] Figure 3 is a view of the embolization device according to preferred embodiment two in an unfolded state;

[0028] Figure 4 is a view of the embolization device according to preferred embodiment three in an unfolded state;

[0029] Figure 5 is a view of the embolization device according to preferred embodiment three in an unfolded state filling an aneurysm.

[0030] [The following is a description of the reference signs]:

[0031] 100-embolization device; 101-proximal mesh body; 102-intermediate mesh body; 103-distal mesh body; 104-distal end of the embolization device; 105-proximal end of the embolization device; 106-proximal connector; 107-distal connector; 200-aneurysm; 210-neck; 300-aneurysm-carrying blood vessel; 410-pushing rod; D-maximum outer diameter of the embolization device when unfolded; d-diameter of the mesh body when unfolded; P-plane in which the intermediate mesh body is located when unfolded. DETAILED DESCRIPTION

[0032] For the purposes of the present application, its objectives, advantages and features, the following detailed description of the application is made in conjunction with the accompanying drawings and specific examples. It is to be noted that the drawings are in a very simplified form and are not drawn to scale, and are only intended to facilitate, clarify and assist in the explanation of the embodiments of the present application. Furthermore, the structures shown in the drawings are often only a part of the actual structures. In particular, the emphasis of the various drawings is different, and sometimes different scales are used.

[0033] As used in this disclosure, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The term "or" is generally employed in its sense of "and / or" unless the context clearly dictates otherwise. The term "plurality" is generally employed in its sense of "at least one" unless the context clearly dictates otherwise. The term "at least two" is generally employed in its sense of "two or more" unless the context clearly dictates otherwise. Thus, definitions of "one end" and "the other end" and "proximal" and "distal" generally refer to two portions that are opposite each other and include more than just the end points. The terms "proximal" and "distal" are defined herein with respect to an embolization device, and as used herein, unless otherwise noted, the terms "distal" and "proximal" refer to the position of an embolization device and / or a portion of an embolization device along a longitudinal axis of the embolization device relative to an operator, and / or the position of a related delivery component (or a portion thereof) along a longitudinal axis of the related delivery component relative to an operator. Furthermore, as used in this disclosure, "mounted," "connected," "coupled," one element "disposed" on another element, should be construed broadly from the general sense of the terms, and generally only means that there is a connection, coupling, engagement or transmission relationship between two elements, and the two elements can be directly connected, coupled, engaged or transmitted, or indirectly connected, coupled, engaged or transmitted through an intermediate element, unless the context clearly dictates otherwise. The specific meaning of the above terms in this disclosure can be understood according to the specific circumstances by those of ordinary skill in the art. Furthermore, directional terms such as above, below, up, down, upward, downward, left, right, etc. are used with respect to the exemplary embodiments as they are shown in the figures, with upward or up being toward the top of the corresponding figure and downward or down being toward the bottom of the corresponding figure. As used herein, "no more than" means less than or equal to the number; "more than" means greater than the number; and "no less than" means greater than or equal to the number. As used in this specification, "target cavity" includes an aneurysm, which includes but is not limited to an aneurysm that is an arterial aneurysm. As used in this specification, the term "one turn" means a full 360° turn, and "less than one turn" means a non-full 360° turn, such as 1 / 2 turn meaning a 180° half turn, and 2 / 3 meaning a 240° angular turn; the longitudinal axis of the embolization device means the central axis of the tubular mesh body extending direction, and the self-axis of the embolization device is the longitudinal axis; and "cross section" means a section perpendicular to the longitudinal axis.

[0034] The present application is further described in detail by the following drawings and preferred embodiments, and the following embodiments and features in the embodiments can be supplemented or combined with each other without conflict. Furthermore, for the sake of brevity, in the following description, the embolization of an aneurysm is described as an example, but this example does not limit the application scenarios of the present application, and as can be understood by those skilled in the art, the embolization device of the present application can also be applied to the embolization of other aneurysms.

[0035] Referring to Figures 1 to 5 The present application provides an embolization device 100 for occluding an aneurysm 200. The aneurysm 200 has a neck 210 opening to a parent vessel 300, and the neck 210 has an opening. The aneurysm 200 can be a dome-shaped aneurysm or a bifurcated aneurysm. It is to be understood that the embolization device 100 of the present application is not limited to the shape of the aneurysm 200 to be treated, and can be applied to aneurysms 200 of different shapes and / or sizes, with a wide range of applications.

[0036] The embolization device 100 has an expanded state and a compressed state, and can be switched between the expanded state and the compressed state. Specifically, the embolization device 100 is used in a compressed state for intravascular delivery to the aneurysm 200; the embolization device 100 is compressed in a delivery catheter (e.g., a delivery sheath, a microcatheter) in the compressed state, and can recover to the expanded state after being detached from the delivery catheter.

[0037] The embolization device 100 specifically includes a proximal mesh body 101, an intermediate mesh body 102, and a distal mesh body 103 connected in sequence along their own axes, and the intermediate mesh body 102 extends between the proximal mesh body 101 and the distal mesh body 103. The embolization device 100 is configured to be arranged in a delivery catheter, so that the distal mesh body 103 is first expanded, then the intermediate mesh body 102 is expanded, and subsequently the proximal mesh body 101 is expanded.

[0038] The proximal mesh body 101 and the distal mesh body 103 each form a spiral structure in the expanded state. The spiral structure formed by the distal mesh body 103 allows the distal end 104 of the embolization device 100 to be tucked inside the embolization device 100 without being directed towards the aneurysm wall, achieving the purpose of the distal end 104 being tucked, or the distal end 104 being parallel (including tangent) to the aneurysm wall without being directed towards the aneurysm wall; since the distal mesh body 103 is the distal portion of the embolization device 100, it is away from the delivery catheter and contacts the aneurysm wall, so when the embolization device 100 is delivered to the aneurysm cavity, the distal end 104 being tucked or parallel to the aneurysm wall can effectively reduce or eliminate the damage or impact of the distal end 104 on the aneurysm wall, reducing the risk of aneurysm rupture. The spiral structure formed by the proximal mesh body 101 allows the proximal end 105 of the embolization device 100 to be tucked inside the embolization device 100 without being directed towards the aneurysm wall, achieving the purpose of the proximal end 105 being tucked, or the proximal end 105 being parallel (including tangent) to the aneurysm wall without being directed towards the aneurysm wall; thereby reducing or eliminating the damage or impact of the proximal end 105 on the aneurysm wall, reducing the risk of aneurysm rupture.

[0039] In particular, when the intratumoral packing is performed, the intermediate mesh body 102 forms a planar arc structure (i.e. an arc mesh body) around the aneurysm with a length of no more than one turn in the expanded state, which can be a circular arc or a non-circular arc. The planar arc structure is curved in the same plane and makes the intermediate mesh body 102 cover the aneurysm neck (i.e. the opening of the neck portion 210) when it is expanded and curved. The shape and size of the planar arc structure not only fit the shape and size of the aneurysm neck, but also extend beyond the inner edge of the aneurysm neck. In this way, the outer mesh surface of the intermediate mesh body 102 covers and occludes the aneurysm neck, forming a continuous dense mesh surface with a spoiler effect at the aneurysm neck, reducing the impact of blood flow on the aneurysm, slowing down the flow rate in the aneurysm cavity, promoting thrombosis, and finally achieving the occlusion of the aneurysm.

[0040] The intermediate mesh body 102 has the following advantages: on the one hand, the proximal end 105 can be positioned at the aneurysm neck, solving the problem that the proximal end 105 is easily extruded by the aneurysm wall and herniated into the parent vessel 300; on the other hand, when the outer mesh surface of the intermediate mesh body 102 covers the aneurysm neck, the mesh surface is basically smooth and flat, which can promote the attachment of endothelial cells at the aneurysm neck, help healing at the aneurysm neck, and accelerate the endothelialization process of the aneurysm neck. Furthermore, since the intermediate mesh body 102 has a length of no more than one turn around the aneurysm cavity when it is expanded in the aneurysm, the length of the intermediate mesh body 102 in the expanded state is reduced. Therefore, while ensuring that the intermediate mesh body 102 can provide sufficient outer mesh surface to cover the aneurysm neck, the number of rotations and the length of rotation of the intermediate mesh body 102 in the aneurysm cavity can be effectively reduced, which not only reduces the frictional impact of the embolization device on the aneurysm wall, reduces the friction between the embolization device and the aneurysm wall, makes the embolization device more stable in the aneurysm and easier to recover to the predetermined shape, ensures the packing effect, but also makes the release process of the entire embolization device simple, reduces the dependence on the personal embolization experience of the doctor during the operation, reduces the operation time, improves the operation efficiency, and at the same time, the embolization device can pack various aneurysms with different shapes and / or sizes, and has a wide range of applications.

[0041] It should be understood that in the conventional embolization device, most of them need to be rotated and shaped in the tumor multiple times, so that the entire tumor cavity is filled with the embolization device, and multiple layers of support in the tumor are achieved by multiple rotations. By doing so, not only is the structure of the entire device complex, but the surgical operation is difficult, and the friction on the tumor wall is large, which increases the risk of aneurysm rupture during the operation. At the same time, the forming resistance in the tumor is large, the entire device is not easy to form, the forming is unstable, and it is not suitable for various aneurysm filling, and the application range is limited. In the present application, the structure of the embolization device 100 is simpler, and the difficulty of surgical operation is reduced. The middle mesh body 102 only needs to be rotated in the tumor with a small amplitude, the friction on the tumor wall is small, and the forming resistance is also small. The entire device is easy to form, and does not need to fill the entire tumor cavity, and can be applied to more aneurysms, overcoming the defects of the conventional embolization device.

[0042] In a preferred embodiment, in the expanded state, the middle mesh body 102 is not in the same plane as the proximal mesh body 101 and the distal mesh body 103. Specifically, the distal mesh body 103 is initially extended distally relative to the middle mesh body 102, then spirally rises a certain height away from the plane P in which the middle mesh body 102 is located, and finally the distal mesh body 103 is buckled in the distal end 104 of the embolization device 100 or parallel to the tumor wall after spiral rotation. Similarly, the proximal mesh body 102 is initially extended proximally relative to the middle mesh body 102, then spirally rises a certain height away from the plane P in which the middle mesh body 102 is located, and finally the proximal mesh body 102 is buckled in the proximal end 105 of the embolization device 100 or parallel to the tumor wall after spiral rotation. The spiral formed by the distal mesh body 103 and the proximal mesh body 101 is staggered with the middle mesh body 102, which can anchor the middle mesh body 102 on the inside of the tumor wall (i.e. the two opposite inside of the aneurysm neck), providing a certain support force, while the proximal mesh body 101 and the distal mesh body 103 also provide auxiliary support on the opposite sides of the tumor cavity, so that the entire embolization device 100 can be stably filled in the tumor cavity, and the device is not easy to shift.

[0043] However, after deployment, the proximal lattice 101 and the distal lattice 103 can be arranged on the same side or different sides of the plane P in which the intermediate lattice 102 lies. The plane P in which the intermediate lattice 102 lies is perpendicular to the cross section of the aneurysm neck. The rotation directions of the proximal lattice 101 and the distal lattice 103 are opposite, but they can be symmetrically arranged or asymmetrically arranged about the central axis of the intermediate lattice 102. Preferably, the embolization device 100 is an axisymmetric structure in the deployed state, i.e., the proximal lattice 101 and the distal lattice 103 are symmetrically arranged about the central axis of the intermediate lattice 102, and the central axis passes through the aneurysm neck, i.e., the central axis is perpendicular to the cross section of the aneurysm neck. The axisymmetric embolization device 100 has good support, and the entire embolization device 100 can be more stably packed in the aneurysm.

[0044] The embolization device 100 is configured to be deployed in the aneurysm 200. When the embolization device 100 is in the compressed state, the proximal lattice 101, the intermediate lattice 102, and the distal lattice 103 are substantially linearly aligned. In the compressed state, the embolization device 100 is configured for delivery through a delivery catheter and insertion via a blood vessel. The embolization device 100 is also configured to be inserted into the neck 210 of the aneurysm 200 when in the compressed state. The embolization device 100 can be switched between the compressed state and the deployed state.

[0045] The body of the embolization device 100 is a tubular lattice, and the embolization device 100 is made of a tubular lattice. The embolization device 100 can be integrally woven from woven wires, or each part can be separately woven and then connected, and then the woven lattice is subjected to a predetermined shaping process to obtain the embolization device 100 with a predetermined shape. To make the support of the embolization device 100 after deployment stronger, the entire tubular lattice is preferably integrally woven from woven wires.

[0046] Preferably, the wire diameter of the woven wires forming the entire tubular lattice is 0.0008 in to 0.002 in, and the total number of woven wires is 48 to 144. In this way, a dense mesh with a large mesh density can be constructed, effectively blocking blood flow in the aneurysm cavity, promoting the formation of intraneurysmal thrombus, and improving the coverage of the aneurysm neck.

[0047] The material of the braided wire includes shape memory material, which can be a metal 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 certain shape recovery capability, such as polydioxanone (PDO), (lactide-ε-caprolactone) copolymer (PLC), polyurethane (PU), poly-norbornene amorphous polymer, etc., or a combination of these materials. Here, the braided wire adopts shape memory metal material or polymer material with certain shape recovery capability, so that the entire tubular mesh body has the function of remembering and recovering the original shape. Preferably, the entire tubular mesh body is braided by visible braided wire, or the entire tubular mesh body is mixedly braided by visible braided wire and non-visible braided wire. Such design can not only make the entire tubular mesh body visible under X-ray, but also ensure the elasticity of the entire tubular mesh body, so that the entire tubular mesh body has strong recovery capability and the ability to maintain the original shape. The metal visible material of the visible braided wire is not particularly limited in the present application, for example, platinum (Pt), platinum-iridium (Pt-Ir), Au (gold), etc. The entire tubular mesh body can be prepared by one or more materials in combination. In other schemes, the entire tubular mesh body can be formed of elastic material or other suitable self-forming material, which can be expanded into the required shape when released from the delivery catheter.

[0048] In order to more stably fill in the aneurysm and also sufficiently cover the aneurysm neck, the cross-sectional diameter d of the intermediate mesh body 102 in the expanded state is preferably not less than 1 / 4 of the maximum outer diameter D of the entire embolization device 100 in the expanded state, more preferably, the cross-sectional diameter d of the intermediate mesh body 102 in the expanded state is 1 / 3-2 / 3 of the maximum outer diameter D of the entire embolization device 100 in the expanded state, which size will not make the intermediate portion 102 too large or too small; if the intermediate portion 102 is too small, the support force will be reduced to some extent, and the aneurysm neck cannot be sufficiently covered; if the intermediate portion 102 is too large, the friction between the intermediate portion 102 and the aneurysm wall will be large, which will increase the forming resistance.

[0049] The maximum outer diameter D of the embolization device 100 in the expanded state can be set according to the size of the aneurysm to be filled. For example, the maximum outer diameter D of the embolization device 100 in the expanded state can be 6-32 mm, which size basically enables the embolization device 100 to fill various aneurysms and also stably support in the aneurysm. Here, the maximum outer diameter refers to the maximum radial dimension of the cross section of the entire embolization device 100 in the same projection plane, such as from the outer surface of the proximal end portion 101 to the outer surface of the distal end portion 103. Figure 1The maximum outer diameter of the entire embolization device 100 after orthographic projection into a projection plane parallel to the direction of the paper is the maximum outer diameter D of the entire embolization device 100 in the expanded state. Moreover, the maximum outer diameter D of the expanded embolization device 100 is greater than the maximum inner diameter of the aneurysm cavity, so that the embolization device 100 is supported in the aneurysm cavity by its own expansion force and does not displace. For example, the diameter d of the entire tubular mesh body in the expanded state can be 2 mm to 8 mm, such as 2 mm, 4 mm, 6 mm or 8 mm, more preferably 4 mm to 6 mm. This arrangement ensures that the intermediate mesh body 102 can cover the neck of various aneurysms after expansion, and the entire embolization device 100 can be stably supported in the aneurysm and will not excessively compress the aneurysm wall, and is easy to shape during the filling process and has good shaping stability.

[0050] In an embodiment, the proximal mesh body 101 and / or the distal mesh body 103 forms a spiral structure of not more than one turn in the expanded state.

[0051] In an embodiment, the proximal mesh body 101 and / or the distal mesh body 103 forms a spiral structure of more than one turn in the expanded state.

[0052] Preferably, the proximal mesh body 101 and / or the distal mesh body 103 forms a spiral structure of not more than one turn, more preferably a spiral structure of less than one turn in the expanded state.

[0053] If the number of spiral turns of the proximal mesh body 101 and / or the distal mesh body 103 is more than one turn or equal to one turn, the embolization device 100 can provide more aneurysm cavity division surfaces and enhance the turbulence effect of the embolization device 100, which is beneficial to promote the formation of thrombus in the aneurysm.

[0054] If the number of spiral turns of the distal mesh body 103 is less than one turn, it is beneficial for the distal end 104 to present an inner buckling state, which better reduces the damage or impact on the aneurysm wall. Preferably, the distal mesh body 103 forms a spiral structure of not less than 1 / 2 turn in the expanded state to ensure that the distal end 104 is buckled, more preferably a spiral structure of 1 / 2 turn to 1 turn, such as 1 / 2 turn, 2 / 3 turn or 1 turn.

[0055] If the number of spiral turns of the proximal mesh body 101 is less than one turn, it is beneficial to shorten the length of the proximal end of the embolization device, which can reduce the kick-in phenomenon of the proximal end 105 (make the delivery catheter back off, which is not conducive to accurate filling), while it is also beneficial for the proximal end 105 to be buckled, avoiding damage or impact on the aneurysm wall by the relatively hard proximal end 105. Preferably, the proximal mesh body 102 forms a spiral of not less than 1 / 2 turn in the expanded state to ensure that the proximal end 105 is buckled, more preferably a spiral structure of 1 / 2 turn to 1 turn, such as 1 / 2 turn, 2 / 3 turn or 1 turn.

[0056] The intermediate mesh body 102 is preferably wound around the aneurysm for 1 / 2 to 1 turn in the expanded state, which can ensure sufficient coverage of the outer mesh surface on the aneurysm neck, and also provide sufficient support, while reducing the impact on the aneurysm wall friction. For example, the intermediate mesh body 102 is wound around the aneurysm for 1 / 2 turn, 2 / 3 turn or 1 turn in the expanded state. In the present application, the length of the planar arc structure of the intermediate mesh body 102 in the expanded state (i.e. the arc length) can be set according to the size of the aneurysm neck relative to the aneurysm cavity.

[0057] The cross-sectional shape of the entire tubular mesh body after expansion is not limited, including but not limited to a circular cross-section, such as a flat cross-section, or other regular or irregular shapes. Irregular shape refers to a special-shaped pattern other than axial symmetry and central symmetry pattern. Preferably, the cross-sectional shape of the entire tubular mesh body after expansion is circular or approximately circular, at which time the support force of the cylindrical braided mesh tube is better, not only easy to form in the aneurysm, but also not easy to displace.

[0058] All the braided wires of the embolization device 100 at the proximal end 105 can be bundled and fixed by the proximal end connector 106, i.e. the proximal end connector 106 bundles and fixes all the braided wire ends at the proximal end 105. All the braided wires of the embolization device 100 at the distal end 104 can be bundled and fixed by the distal end connector 107, i.e. the distal end connector 107 bundles and fixes all the braided wire ends at the distal end 104. Preferably, the proximal end connector 106 and / or the distal end connector 107 is made of a metal developing material, including and / or coated with a metal developing material, to enhance the visibility of the embolization device 100 at the proximal end 105 and / or the distal end 104.

[0059] In an embodiment, in the expanded state, the cross-sectional diameter d of the entire embolization device 100 first increases and then decreases from the proximal end to the distal end, or the diameter d of the entire embolization device 100 repeatedly increases and then decreases from the proximal end to the distal end, so that the entire embolization device 100 is configured into a shuttle shape, i.e. a structure with small ends and a large middle, so as to be compressed to a smaller size, and also to improve the flexibility of the embolization device, further reduce the pushing resistance, and reduce the impact or damage to the aneurysm wall.

[0060] For example, the proximal end connector 106 and / or the distal end connector 107 is made of a metal developing material, including and / or coated with a metal developing material, to enhance the visibility of the embolization device 100 at the proximal end 105 and / or the distal end 104. Figure 1 and Figure 3As shown, the embolization device 100 can be delivered to the target lesion site (aneurysm 200) by a delivery system. The delivery system includes a delivery catheter (not shown) and a push rod 410, the distal end of which is releasably connected to the proximal end 105 of the embolization device 100. The push rod 410 extends along the tangent direction of the helical line of the helical shape of the proximal mesh body 101 in the expanded state, so that the outer side of the middle mesh body 102 of the embolization device 100 covers the aneurysm neck when the push rod is released, thereby improving the metal coverage of the aneurysm neck and avoiding herniation of the proximal end 105 of the embolization device 100. The release mode between the push rod 410 and the proximal end 105 can use existing technologies such as heating release, electrolytic release, mechanical release, or hydrolysis release, which are not limited. The function of the push rod 410 is to push the embolization device 100 out of the delivery catheter to achieve the filling of the embolization device 100 in the aneurysm 200.

[0061] In actual operation, the delivery catheter is first inserted into the blood vessel and guided to the aneurysm 200 near the blood vessel, and the distal end of the delivery catheter is positioned in the blood vessel adjacent to the aneurysm 200. Then, the embolization device 100 is inserted into the lumen of the delivery catheter, and then under the help of the push rod 410, the embolization device 100 can move from inside the delivery catheter to outside the delivery catheter, so that the embolization device 100 is guided and positioned in the aneurysm 200.

[0062] Next, the present application will be further described in detail in conjunction with the drawings and the following specific embodiments.

[0063] <Embodiment One>

[0064] Figure 1 shows a view of the embolization device 100 in the expanded state according to preferred embodiment one of the present application, Figure 2 shows a view of the embolization device 100 filling the aneurysm 200 in the expanded state according to preferred embodiment one of the present application.

[0065] As shown in Figure 1 and Figure 2 shown, in embodiment one of the present application, in the expanded state, the distal mesh body 103 of the embolization device 100 forms a 1 / 2 turn helical structure, the middle mesh body 102 forms a planar arc structure (for example, a circular arc structure) with a length of 2 / 3 turns around the aneurysm 200, and the proximal mesh body 101 forms a 1 / 2 turn helical structure.

[0066] When implanted in vivo, the distal mesh body 103 can guide the initial stage of filling the aneurysm 200; the intermediate mesh body 102 is released in sequence under the guidance of the distal mesh body 103 to fill the aneurysm 200 until the outer side thereof covers the aneurysm neck, forming a continuous dense mesh covering surface; then, the proximal mesh body 101 continues to be released until the entire embolization device 100 is pushed out of the delivery catheter, completing the filling.

[0067] In this embodiment, the proximal mesh body 101 and the distal mesh body 103 are both curved towards the intermediate mesh body 102, so that the proximal end 105 and the distal end 104 are in an inner buckling state in the aneurysm cavity, avoiding damage or impact of the relatively hard proximal and distal ends (for example, including the proximal end connector 106 and the distal end connector 107) on the aneurysm wall; and the intermediate mesh body 102 is supported in the aneurysm cavity, plus the auxiliary support of the distal mesh body 103 and the proximal mesh body 101, so that the entire embolization device 100 can be stably filled in the aneurysm cavity.

[0068] In this embodiment, the embolization device 100 in the expanded state is approximately an axisymmetric structure, that is, the proximal mesh body 101 and the distal mesh body 103 are approximately symmetrically arranged about the central axis of the intermediate mesh body 102, at this time, the entire embolization device 100 has good supportability, which can ensure that the entire device is stably filled in the aneurysm.

[0069] <Embodiment Two>

[0070] Figure 3 A view of the embolization device 100 of the present application in the expanded state according to the preferred embodiment two is shown. As shown in the figure, Figure 3 In the embodiment two of the present application, in the expanded state, the distal mesh body 103 of the embolization device 100 forms a spiral structure of 1 turn, the intermediate mesh body 102 forms a planar arc structure of 1 turn or close to 1 turn around the aneurysm, and the proximal mesh body 101 forms a spiral structure of 1 turn.

[0071] When implanted in vivo, the distal mesh body 103 can guide the initial stage of filling the aneurysm 200; the intermediate mesh body 302 is released in sequence under the guidance of the distal mesh body 103 to fill the aneurysm 200 until the outer side thereof covers the aneurysm neck, forming a continuous dense mesh covering surface; then, the proximal mesh body 101 continues to be released until the entire embolization device 300 is pushed out of the delivery catheter, completing the filling.

[0072] In this embodiment, the distal mesh body 103 and the proximal mesh body 101 are parallel (including tangent) to the aneurysm wall in the aneurysm cavity, avoiding damage or impact of the relatively hard proximal and distal ends on the aneurysm wall; and the intermediate mesh body 102 is supported in the aneurysm cavity, plus the auxiliary support of the distal mesh body 103 and the proximal mesh body 101, so that the entire embolization device 100 can be stably filled in the aneurysm cavity.

[0073] In this embodiment, the embolization device 100 is also approximately an axisymmetric structure in the expanded state, that is, the proximal mesh body 101 and the distal mesh body 103 are approximately symmetrically arranged about the central axis of the intermediate mesh body 102, at this time, the support of the entire embolization device 100 is good, and the entire device can be ensured to be stably packed in the aneurysm.

[0074] Compared with the first embodiment, the proximal mesh body 101 and the distal mesh body 103 in the second embodiment can provide more aneurysm cavity segmentation surfaces due to more spiral turns, and enhance the turbulence effect of the embolization device 100.

[0075] <Embodiment Three>

[0076] Figure 4 A view of the embolization device 100 of the present application in the expanded state according to the preferred third embodiment is shown, Figure 5 A view of the embolization device 100 of the present application in the expanded state according to the preferred third embodiment is shown.

[0077] As Figure 4 and Figure 5 shown, in the third embodiment of the present application, in the expanded state, the distal mesh body 103 of the embolization device 100 forms a spiral structure of 1 turn, the intermediate mesh body 102 forms a planar arc structure of 1 turn or close to 1 turn around the aneurysm, and the proximal mesh body 101 forms a spiral structure of 1 / 2 turn.

[0078] When implanted in the body, the distal mesh body 103 can guide the initial stage of packing the aneurysm 200; the intermediate mesh body 102 is sequentially released for packing under the guidance of the distal mesh body 103 until the outer side covers the aneurysm neck, forming a continuous dense mesh covering surface; and the proximal mesh body 101 continues to be released until the entire embolization device 100 is pushed out of the delivery catheter, completing the packing.

[0079] In this embodiment, the distal end 104 of the distal mesh body 103 is parallel to (including tangent to) the aneurysm wall in the aneurysm cavity, and the proximal end 105 of the proximal mesh body 101 is in an inner buckling state in the aneurysm cavity, avoiding damage or impact on the aneurysm wall by the relatively hard proximal and distal ends; and the intermediate mesh body 102 is supported in the aneurysm cavity, plus the auxiliary support of the distal mesh body 103 and the proximal mesh body 101, so that the entire embolization device 100 can be stably packed in the aneurysm cavity.

[0080] In this embodiment, the embolization device 100 is a non-axisymmetric structure in the expanded state, that is, the proximal mesh body 101 and the distal mesh body 103 are asymmetrically arranged about the central axis of the intermediate mesh body 102.

[0081] Compared with Example Two, the proximal mesh body 101 in this example is shortened, because once the middle mesh body 102 covers the aneurysm neck, it is more difficult to push the proximal mesh body 101 in the aneurysm cavity, and shortening the length of the proximal mesh body 101 can reduce the kick phenomenon of the proximal end 105 of the embolization device 100, and also enable the proximal end 105 to buckle, avoiding damage to the aneurysm wall by the relatively hard proximal end; and the middle mesh body 102 is supported in the aneurysm cavity, and the distal mesh body 103 and the proximal mesh body 101 provide auxiliary support, so that the entire embolization device 100 can be stably packed in the aneurysm cavity.

[0082] In summary, it should be understood that the present application relies on the outer dense mesh surface of the middle mesh body of the embolization device to cover the aneurysm neck, achieve the effect of turbulence in the aneurysm cavity, and thus achieve the occlusion of the aneurysm. In particular, when the distal and proximal mesh bodies of the embolization device form a certain angle with the middle mesh body (i.e., not in the same plane), the embolization device can better adhere to the aneurysm wall for fixation, preventing displacement of the embolization device, and the distal and proximal spiral mesh bodies fill the aneurysm cavity, dividing the space in the aneurysm cavity, which can improve the turbulence effect in the aneurysm cavity while occluding the aneurysm neck, promoting thrombosis in the aneurysm. In more detail, the entire embolization device is simple to release, reducing the dependence on the personal experience of the doctor in the surgical process of aneurysm embolization, and reducing the operation time; the middle mesh body of the entire embolization device can occlude the aneurysm, and the operation is flexible, the two ends are not in the same plane as the middle mesh body, the middle mesh body is anchored on both sides of the inside of the aneurysm wall, providing stronger support to prevent displacement of the embolization device; the middle mesh body can provide a continuous dense mesh covering surface at the aneurysm neck while not affecting blood flow at the aneurysm neck due to additional rivets, and the endothelialization process can be more uniform; the entire embolization device is completely located in the aneurysm, which can avoid the use of double anti-platelet drugs; the entire embolization device can gradually complete the packing through the radial length, which is convenient for delivery through a delivery catheter with a smaller inner diameter, so that it can reach more lesion locations; the entire embolization device can promote the formation of thrombus in the aneurysm while improving the coverage of the aneurysm neck, and accelerate the embolization of the aneurysm.

[0083] Although the present application has been disclosed as above, it is not limited thereto. Those skilled in the art can make various modifications and variations to the present application without departing from the spirit and scope of the present application. Thus, if these modifications and variations of the present application fall within the scope of the present application and its equivalent technology, the present application is also intended to include these modifications and variations.

Claims

1. An embolization device, made of a tubular mesh, used for sealing hemangiomas, characterized in that, The embolization device has an deployed state and a compressed state, and can switch between the deployed state and the compressed state; The embolization device includes a proximal grid body, an intermediate grid body, and a distal grid body connected sequentially along its own axis; the proximal grid body and the distal grid body both form a spiral structure when in the deployed state; the intermediate grid body forms a planar arc structure with a length not exceeding one turn around the hemangioma when in the deployed state, and is used to cover the neck of the hemangioma. In the unfolded state, the intermediate mesh body is not in the same plane as the proximal mesh body and the distal mesh body. The proximal mesh body and the distal mesh body are arranged on the same side or different sides of the plane where the intermediate mesh body is located. The plane where the intermediate mesh body is located is perpendicular to the cross-section of the neck orifice. The rotation directions of the proximal mesh body and the distal mesh body are opposite. The proximal mesh body and the distal mesh body are symmetrical or asymmetrical about the central axis of the intermediate mesh body. The central axis of the intermediate mesh body is used to pass through the neck orifice.

2. The embolization device according to claim 1, characterized in that, The distal mesh body forms a spiral structure of no more than one turn when it is in the unfolded state, and / or the proximal mesh body forms a spiral structure of no more than one turn when it is in the unfolded state.

3. The embolization device according to claim 2, characterized in that, The distal mesh body forms a spiral structure of 1 / 2 turn to 1 turn when it is in the unfolded state, and / or the proximal mesh body forms a spiral structure of 1 / 2 turn to 1 turn when it is in the unfolded state.

4. The embolization device according to claim 1, characterized in that, The intermediate mesh, when in the unfolded state, wraps around the hemangioma for 1 / 2 to 1 turn.

5. The embolization device according to claim 1, characterized in that, The cross-sectional diameter of the intermediate mesh body in the deployed state is not less than 1 / 4 of the maximum outer diameter of the entire embolization device in the deployed state.

6. The embolization device according to claim 5, characterized in that, The cross-sectional diameter of the intermediate mesh body in the deployed state is 1 / 3 to 2 / 3 of the maximum outer diameter of the entire embolization device in the deployed state.

7. The embolization device according to claim 1, characterized in that, The embolization device is an axisymmetric structure in the deployed state, with the proximal grid and the distal grid arranged symmetrically about the central axis of the intermediate grid.

8. The embolization device according to claim 1, characterized in that, In the deployed state, the cross-sectional diameter of the embolization device first increases and then decreases from the proximal end to the distal end, or the cross-sectional diameter of the embolization device repeatedly increases and then decreases from the proximal end to the distal end.

9. The embolization device according to claim 1, characterized in that, The embolization device is woven from braided yarn as a whole or as a single piece.

10. The embolization device according to claim 9, characterized in that, The material of the braided filaments includes shape memory materials and / or metal developing materials, the diameter of the braided filaments is 0.0008in to 0.002in, and the total number of braided filaments is 48 to 144.

11. The embolization device according to claim 9, characterized in that, All the braided wires at the distal end of the embolization device are secured by a distal connector, and all the braided wires at the proximal end of the embolization device are secured by a proximal connector. The distal connector and / or the proximal connector are made of a metallic radiopaque material.

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