CN217827977U - Embolization device - Google Patents

Abstract

The utility model relates to an embolism device, which is made of a tubular grid body and is used for plugging a target cavity, wherein the embolism device has an expansion state and a compression state and can be switched between the expansion state and the compression state; the embolism device comprises a near-end grid body, an intermediate grid body and a far-end grid body which are sequentially connected along the axis of the embolism device; the proximal mesh body and the distal mesh body both form a helical structure in the expanded state; the middle grid body forms a plane arc structure which does not exceed one circle around the length of the target cavity in the unfolding state and is used for covering the opening of the target cavity. The utility model discloses can realize the shutoff of target cavity, and the shaping is stable in target cavity, realizes the recovery of prefabricated shape easily, also realizes easily that the damage to the chamber wall is little moreover to target cavity open-ended shutoff, and the operation degree of difficulty is low, and application scope is wide.

Description

Embolization device

Technical Field

The utility model relates to the technical field of medical equipment, concretely relates to embolism device for shutoff target cavity (for example, hemangioma).

Background

Intracranial aneurysm is pathological protrusion of intracranial artery wall, the incidence rate is 5% -10%, MRA research shows that the incidence rate of unbroken aneurysm of adults 35-75 years old in China is about 7.0%. Although subarachnoid hemorrhage caused by rupture of intracranial aneurysm accounts for about 5% of cerebral apoplexy, the death rate of the first rupture is 20% -30%, and the death rate of the second rupture is up to 60%. The fundamental idea in treating aneurysms is to completely isolate the aneurysm from the blood circulation by therapeutic means. The current treatment means mainly comprise craniotomy clamping treatment and intravascular intervention treatment. The intravascular interventional therapy mode can avoid brain tissues and reach lesions, and the characteristic of micro-trauma makes the intravascular interventional therapy mode become the mainstream for treating intracranial aneurysms at present. The current endovascular intervention treatments mainly comprise the following treatments:

the aneurysm intracavity embolism spring ring is a main method for treating aneurysm at present, and the treatment principle is that thrombosis is promoted by changing local blood flow dynamics factors, so that the aneurysm plugging and treatment are realized. However, aneurysms have different morphologies, incomplete coil packing can lead to recanalization of the aneurysm, while over packing can lead to rupture during aneurysm surgery, requiring greater skill and experience from the physician. Moreover, the coil packing needs repeated packing for many times, the embolization efficiency is low, and in some cases, the coil packing needs the assistance of a stent, a balloon and a microcatheter, so that the operation is complex. And for wide-diameter aneurysms, the spring ring is easy to hernia into the parent artery to influence blood flow, and in severe cases, the spring ring can also cause angiostenosis.

The blood flow guiding device is used as a major breakthrough of intracranial aneurysm intravascular treatment, and brings a brand-new method for treating complicated aneurysm, the treatment principle is that a dense-mesh stent is placed in a parent artery, after the intracavity of a diseased blood vessel is reconstructed, the inner surface of the blood vessel cavity is reshaped through a neovascular intima on the surface of a tumor neck. The application of the blood flow guiding device obviously improves the long-term curative effect of large and huge aneurysms and obviously reduces the use of spring coils. And according to the simulation analysis of computer hemodynamics, when the metal coverage rate reaches 30-50%, the blood flow in the aneurysm cavity can be obviously reduced, and the cure rate is high. However, the use of blood flow directing devices has led to patients relying on dual anti-platelet therapy for long periods of time, with the risk of bleeding complications following surgery. In addition, there is a risk of delayed rupture after treatment of a portion of a large aneurysm.

At present, some novel disposable embolization devices are usually prepared from shape memory materials, are shaped into a sphere, a column or a disk, are delivered through a catheter, are pushed out from a sheath after reaching a specific position, and are self-expanded to restore to an initial pre-shaped shape, so that the purpose of plugging aneurysm is achieved. Various embolization devices currently exist: for example, the first embolism instrument is a spherical or cylindrical dense net device with riveting points at two ends, the whole device expands in a tumor cavity, and aneurysm treatment is realized by covering a tumor neck with a near-end dense net; for example, the second embolism instrument is characterized in that a developing wire and a peripheral self-expanding memory alloy jointly form a three-dimensional net structure, can be released and recovered through a catheter like a spring ring, can be spherical when being filled in a tumor, and further plays a role in turbulent flow; as another example, a third embolic device is woven from a double layer of nitinol; and a fourth embolism instrument which is formed by weaving double-layer memory alloy, is in a disc shape without limitation, is in a tulip shape under the limitation of a tumor wall when being released in the tumor body, can be stabilized at the lower part of the tumor body and covers the tumor neck, and further plays a role in reconstructing hemodynamics. However, the rivet point design of the above first embolization device at the proximal end makes the device have a symmetrical structure, so that it has an orientation for covering the neck of the aneurysm, and is mainly used for treating bifurcation wide-diameter aneurysms, and is especially suitable for regular aneurysms; the first embolism instrument has an impact effect on the tumor wall at the far-end rivet point design, so that the tumor wall is easy to rupture, and the aneurysm bleeds; in some cases, the proximal rivet point of the first embolization device is extruded by the tumor wall and hernias into the parent artery, which affects the endothelialization process of the tumor neck; in addition, the first embolic device is generally in the shape of a single sphere or cylinder, and although the contact area is large, the support force is insufficient, the long-term stability in the tumor cavity is not good, and the displacement is easy. Above second kind embolism apparatus is stereotyped into three-dimensional network structure by a plurality of slice nets, is similar to spherically, because between the three-dimensional network structure and with the tumour wall between frictional force great, the shaping stability of device in the tumour is not good, is difficult to resume predetermined shape, influences the filling effect, need cooperate the spring coil to use moreover, the operation is complicated. The above third embolic device works in a principle similar to the first embolic device, and thus has the same problems as the first embolic device. The proximal rivet point of the fourth embolization device is also easy to be extruded by the tumor wall to enter the parent artery, and is suitable for the apical aneurysm, and the position of the embolization device needs to be repeatedly adjusted and placed, otherwise, the stability of the embolization device in the aneurysm is affected, and therefore, the embolization efficiency is low.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide an embolism device for realize the shutoff treatment of target cavities such as hemangioma, it need not to fill up whole target cavity, not only the shaping is more stable in target cavity, realizes the recovery of prefabricated shape more easily, realizes more easily that it is little to the shutoff of target cavity open-ended, moreover to the damage on chamber wall, has reduced the cracked risk of target cavity, and the complexity of whole embolism device reduces simultaneously, and the operation degree of difficulty reduces, and application scope is wider.

In order to achieve at least one of the above objects, the present invention provides an embolic device made of a tubular mesh body and used for occluding a target cavity, the embolic device having a deployed state and a compressed state and being switchable between the deployed state and the compressed state;

the embolism device comprises a near-end grid body, an intermediate grid body and a far-end grid body which are sequentially connected along the axis of the embolism device; the proximal mesh body and the distal mesh body both form a helical structure when in the expanded state; the intermediate mesh body forms a planar arc structure that does not exceed one turn around the length of the target cavity in the deployed state and is used to cover the opening of the target cavity.

In one embodiment, in the expanded state, the intermediate 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 disposed on the same side or different sides of the plane in which the intermediate mesh body is disposed.

In one embodiment, the distal mesh body forms no more than one turn of the helical structure in the deployed state and/or the proximal mesh body forms no more than one turn of the helical structure in the deployed state.

In one embodiment, the distal lattice body forms a helix of 1/2 to 1 turn in the deployed state and/or the proximal lattice body forms a helix of 1/2 to 1 turn in the deployed state.

In one embodiment, the intermediate mesh body has a length of 1/2 to 1 turn around the target cavity in the deployed state.

In an embodiment, 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 embolic device in the deployed state.

In one embodiment, 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 embolic device in the deployed state.

In one embodiment, the embolic device is an axisymmetric structure in the deployed state, the proximal mesh and the distal mesh being symmetrically disposed about a central axis of the middle mesh for passing through the opening of the target lumen.

In one embodiment, the cross-sectional diameter of the occluding device increases and then decreases from the proximal end to the distal end in the deployed state, or the cross-sectional diameter of the occluding device repeatedly increases and then decreases from the proximal end to the distal end.

In one embodiment, the embolic device is integrally or integrally braided from braided filaments.

In one embodiment, the diameter of the braided wire is 0.0008-0.002 in, the total number of braided wires is 48-144, the braided wire is made of shape memory material and/or the braided wire is capable of developing.

In one embodiment, all of the braided wires of the embolic device at the distal end are captively secured by a distal connector and all of the braided wires of the embolic device at the proximal end are captively secured by a proximal connector, and the distal connector and/or the proximal connector are made of a metallic visualization material.

In the utility model provides an in the embolism device, include: made of a tubular mesh body, said embolic device having an expanded state and a compressed state and being switchable between said expanded state and said compressed state; the embolism device comprises a near-end grid body, a middle grid body and a far-end grid body which are sequentially connected along the axis of the embolism device; the proximal mesh body and the distal mesh body both form a helical structure when in the expanded state; the intermediate mesh body forms a planar arc structure that does not exceed one turn around the length of the target cavity in the deployed state and is used to cover the opening of the target cavity. Use hemangioma as the illustration, when so configuring, make the utility model discloses can realize hemangioma's shutoff treatment to can realize following at least one advantage:

(1) The spiral structure formed by the near-end grid body can enable the near end of the embolism device to be buckled inside or parallel to (including tangent to) the tumor wall, so that the damage or impact of the near end of the embolism device on the tumor wall is reduced; meanwhile, the spiral structure formed by the far-end grid body can enable the far end of the embolism device to be buckled in or parallel to (including tangent to) the tumor wall, so that the damage or impact of the far end of the embolism device on the tumor wall is reduced;

(2) The middle mesh body is filled in the tumor according to the prefabricated shape under the guidance of the far-end mesh body, and finally the outer side mesh surface of the middle mesh body covers the inner side of the tumor neck to form a continuous dense mesh surface with a flow disturbing effect, so that the impact effect of blood flow on the hemangioma is reduced, the flow speed in the tumor cavity is reduced, the thrombosis is promoted, and the hemangioma is finally blocked;

(3) Because the middle mesh body forms a plane arc structure which is not more than one circle around the length of the hemangioma (target cavity) when being unfolded, the rotation length and the rotation times of the middle mesh body in the tumor cavity are reduced while the middle mesh body can provide enough outer side mesh surface to cover the tumor neck, the friction influence of the embolism device on the tumor wall can be effectively reduced, the friction force between the middle mesh body and the tumor wall is reduced, the forming of the embolism device in the tumor is more stable, the embolism device can be more easily restored to a prefabricated shape, the plugging effect is ensured, the release process of the whole embolism device is simple, the dependence on personal embolism experience of doctors in the operation process can be reduced, the operation time is reduced, the operation efficiency is improved, meanwhile, the hemangiomas with different shapes and/or sizes can be plugged by the embolism device, and the application range is wide.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

Fig. 1 is a view of an embolic device according to a first preferred embodiment of the present invention in a deployed state;

FIG. 2 is a view of the embolic device of the present invention occluding an aneurysm in a deployed state according to a first preferred embodiment;

fig. 3 is a view of the embolic device in a deployed state according to a second preferred embodiment of the present invention;

fig. 4 is a view of the embolic device of the present invention in a deployed state, according to a third preferred embodiment;

fig. 5 is a view of the embolic device occluding an aneurysm according to the third preferred embodiment of the present invention in a deployed state.

[ reference numerals are described below ]:

100-an embolic device; 101-a proximal mesh; 102-an intermediate mesh body; 103-a distal mesh; 104-the distal end of the embolic device; 105-the proximal end of the embolic device; 106-proximal connector; 107-distal connector; 200-an aneurysm; 210-a neck; 300-tumor-bearing blood vessels; 410-a push rod; d-maximum outer diameter of the embolic device when deployed; d-diameter of the mesh when expanded; p-the plane in which the intermediate mesh body lies when expanded.

Detailed Description

To make the objects, advantages and features of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings and specific embodiments. It is to be noted that the drawings are in simplified form and are not to scale, but rather are provided for the purpose of facilitating and distinctly claiming the embodiments of the present invention. Further, the structures illustrated in the drawings are intended to be part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.

As used in this application, the singular forms "a," an, "and" the "include plural referents, the term" or "is generally employed in its sense including" and/or, "the terms" a "and" an "are generally employed in their sense including" at least one, "and the terms" at least two "are generally employed in their sense including" two or more. Thus, the definitions of "one end" and "the other end" and "proximal end" and "distal end" generally refer to the corresponding two parts, which include not only the end points. The terms "proximal" and "distal" are defined herein with respect to the embolic device, and as used herein, unless otherwise specified, the terms "distal" and "proximal" refer to the position of the embolic device and/or portions of the embolic device relative to the operator along the longitudinal axis of the embolic device, and/or the position of the associated delivery member (or portions thereof) relative to the operator along the longitudinal axis of the associated delivery member. Furthermore, as used in the present application, the terms "mounted," "connected," and "disposed" on another element should be construed broadly, and generally only mean that there is a connection, coupling, fit, or drive relationship between the two elements, and that the connection, coupling, fit, or drive between the two elements can be direct or indirect through intervening elements, and should not be construed as indicating or implying any spatial relationship between the two elements, i.e., an element can be located in any orientation within, outside, above, below, or to one side of another element unless the content clearly dictates otherwise. The specific meaning of the above terms in the present invention can be understood according to specific situations by those skilled in the art. Moreover, directional terminology, such as upper, lower, upward, downward, left, right, etc., is used with respect to the exemplary embodiments as they are shown in the figures, with the upward or upward direction being toward the top of the corresponding figure and the downward or downward direction being toward the bottom of the corresponding figure. As used herein, "not more than" means less than or equal to the present number; "exceeding" means greater than the present number; "not less than" means not less than the present number. As used herein, "target lumen" includes a vascular tumor, including but not limited to an aneurysm. As used herein, the term "one turn" refers to a full turn winding of 360 °, less than one turn refers to a non-full turn winding of less than 360 °, e.g., 1/2 turn refers to a half turn winding of 180 °,2/3 refers to an angular winding of 240 °; the longitudinal axis of the embolism device is the central axis of the tubular grid body in the extending direction, and the self axis of the embolism device is the longitudinal axis; "Cross-section" means a section perpendicular to the longitudinal axis.

The invention is explained in more detail below with reference to the drawings and preferred exemplary embodiments, and the features of the embodiments and exemplary embodiments described below can be supplemented or combined with one another without conflict. And for the sake of simplicity, in the following description, the illustration of the aneurysm plugging is given, but this illustration is not intended to limit the application of the invention, as the skilled person will understand, the embolization device of the invention may also be applied to the plugging of other aneurysms.

Referring to fig. 1-5, the present invention provides an embolization device 100 for embolizing an aneurysm 200. The aneurysm 200 has a neck portion 210 that opens to a parent vessel 300, the neck portion 210 having an opening. The aneurysm 200 may be a apical aneurysm or a bifurcation aneurysm. It should be appreciated that the embolization device 100 of the present invention is not limited to the shape of the aneurysm 200 to be treated, and may be adapted to aneurysms 200 of different shapes and/or sizes, and may be used in a wide range of applications.

The embolic device 100 has a deployed state and a compressed state, and is switchable between the deployed state and the compressed state. In particular, the embolic device 100 is for intravascular delivery to the compressed state of the aneurysm 200; the embolic device 100 is compressed into a compressed state within a delivery catheter (e.g., delivery sheath, microcatheter) and is also capable of returning to the deployed state after exiting the delivery catheter.

The embolization device 100 specifically comprises a proximal mesh body 101, an intermediate mesh body 102 and a distal mesh body 103, which are connected in sequence along their axes, the intermediate mesh body 102 extending between the proximal mesh body 101 and the distal mesh body 103. The embolic device 100 is configured to be disposed in a delivery catheter such that the distal mesh 103 is deployed first, then the middle mesh 102 is deployed, and then the proximal mesh 101 is deployed.

Wherein the proximal mesh body 101 and the distal mesh body 103 both form a helical structure when in the expanded state. The helical structure formed by the distal mesh 103 enables the distal end 104 of the embolization device 100 to be folded inside the embolization device 100 without facing the tumor wall, so as to achieve the purpose of buckling the distal end 104 inside, or enables the distal end 104 to be parallel (including tangential) to the tumor wall without facing the tumor wall; since the distal mesh 103 is the distal portion of the embolic device 100 that exits the delivery catheter and contacts the aneurysm wall, the invagination or parallelism of the distal end 104 with 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 when the embolic device 100 is delivered to the aneurysm cavity. The helical structure formed by the proximal mesh 101 enables the proximal end 105 of the embolization device 100 to be folded inside the embolization device 100 without facing the tumor wall, so as to achieve the purpose of buckling the proximal end 105 inside, or enables the proximal end 105 to be parallel (including tangent) to the tumor wall without facing the tumor wall; thereby reducing or eliminating damage or impingement of the proximal end 105 on the tumor wall and reducing the risk of aneurysm rupture.

In particular, during intratumoral tamponade, the intermediate mesh body 102, in the deployed state, forms a planar arcuate structure (i.e., an arcuate mesh body) that does not exceed one revolution in length around the aneurysm, which may be an arc or a non-arc. The planar arc structure bends in the same plane and allows the medial mesh body 102 to cover the neck opening (i.e., the opening of the neck 210) when it is unfolded and bent. The shape and the size of plane arc structure not only adapt to the shape and the size of tumour neck, but also can extend beyond tumour neck intraoral edge to this middle grid body 102's outside wire side covers and blocks off tumour neck, forms the continuous dense net face that has the vortex effect at tumour neck, reduces the impact of blood flow in to the aneurysm, slows down the velocity of flow in the tumour intracavity, promotes thrombosis, realizes the shutoff of aneurysm at last.

The above middle mesh body 102 also has the benefits of: on one hand, the proximal end 105 can be prevented from being positioned at the tumor neck opening, the problem that the proximal end 105 is easily extruded by the tumor wall to herd into the tumor-carrying blood vessel 300 is solved, on the other hand, when the tumor neck opening is covered by the outer mesh surface of the middle mesh body 102, because the mesh surface is basically smooth and flat, the endothelial cell attachment at the neck part of the aneurysm can be promoted, the healing on the neck part of the aneurysm can be helped, the endothelialization process of the tumor neck opening is accelerated, furthermore, because the length of the middle mesh body 102 around the tumor cavity when being unfolded in the tumor does not exceed one circle, the length of the middle mesh body 102 in the unfolded state is reduced, the rotation times and the rotation length of the middle mesh body 102 in the tumor cavity can be effectively reduced while the middle mesh body 102 can provide enough outer mesh surface to cover the tumor neck, the friction influence of the embolization device on the tumor wall is reduced, the friction force between the tumor wall is reduced, the embolization device is more stably formed in the tumor, the tumor can be more easily restored to the preset shape, the embolization device is ensured to be released, the whole embolization device can be reduced, the embolization device in the operation process, the embolization process can be reduced, the embolization device can be easily, and the embolization device can be applied to the embolization device, the embolization device has wide operation process, and the embolization device has wide range of the embolization process, and the embolization device can be applied to the embolization process, and the embolization device.

It should be understood that, in traditional embolism apparatus, most need rotate the shaping many times in the tumour, make whole tumour cavity filled up by the embolism apparatus, and realize the multilayer support in the tumour through many times of rotations, do so, not only the structure of whole apparatus is complicated, the operation degree of difficulty is big, and the friction influence to the tumour wall is big, in the operation process, the easy risk that takes place the aneurysm and break, meanwhile, the shaping resistance in the tumour is also big, whole apparatus is difficult to the shaping, the shaping is unstable, and also be unsuitable for the packing of various aneurysms, and the range of application is limited. And the utility model discloses in, embolism device 100's structure is simpler, and the operation degree of difficulty reduces, and wherein middle grid body 102 only need do the rotation of small range in the tumour, and is little to the friction influence of tumour wall, and is corresponding, and the shaping resistance is also little, and the easy shaping of whole device, and need not to fill up whole tumour chamber, can be applicable to more aneurysms, has overcome the defect that traditional embolism apparatus exists.

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 initially extends distally relative to the intermediate mesh body 102, then spirals upward to a certain height away from the plane P in which the intermediate mesh body 102 lies, and finally the distal mesh body 103 spirals to make the distal end 104 of the embolization device 100 snap-in or parallel to the tumor wall; similarly, the proximal mesh body 102 initially extends proximally relative to the intermediate mesh body 102, then spirals upward to a height away from the plane P in which the intermediate mesh body 102 lies, and finally the proximal mesh body 102 spirals to snap the proximal end 105 of the occluding device 100 into or parallel with the tumor wall. The advantage of staggering the helix formed by the distal mesh 103 and the proximal mesh 101 from the middle mesh 102 is that the middle mesh 102 can be anchored on both sides of the inside of the tumor wall (i.e., the two opposite sides of the tumor neck opening) to provide a certain supporting force, and the proximal mesh 101 and the distal mesh 103 can be supported in the tumor cavity on both sides of the tumor cavity, so that the whole embolization device 100 can be stably packed in the tumor cavity, and the device is not easy to shift.

However, after deployment, the proximal mesh body 101 and the distal mesh body 103 may be arranged on the same side or on different sides of the plane P in which the intermediate mesh body 102 is located. The plane P of the middle mesh 102 is perpendicular to the cross section of the neck opening. The rotation directions of the proximal mesh body 101 and the distal mesh body 103 are opposite, but both may be symmetrically or asymmetrically arranged about the central axis of the middle mesh body 102. Preferably, the embolic device 100 is in an axisymmetric configuration in the deployed state, i.e. the proximal mesh 101 and the distal mesh 103 are symmetrically arranged about a central axis of the intermediate mesh 102 for passing through the neck opening, i.e. the central axis is perpendicular to the cross-section of the neck opening. The axisymmetric embolic device 100 provides good support and the entire embolic device 100 can be more stably packed within the tumor.

The embolic device 100 is configured to be deployed in an aneurysm 200. When the embolic device 100 is in a compressed state, wherein the proximal mesh 101, the intermediate mesh 102, and the distal mesh 103 are substantially linearly aligned. In the compressed state, the embolic device 100 is configured for delivery through a delivery catheter and insertion through a blood vessel. The embolic device 100 is also configured to be inserted into the neck 210 of the aneurysm 200 when in the compressed state. The embolic device 100 is switchable between a compressed state and a deployed state.

The body of the embolic device 100 is a tubular mesh body from which the embolic device 100 is made. The embolization device 100 may be integrally or integrally formed by knitting, or may be formed by separately knitting and connecting each part, and then pre-shaping the knitted mesh body to obtain the embolization device 100 with a pre-fabricated shape. To provide greater support after deployment of the embolic device 100, the entire tubular mesh body is preferably integrally or unitarily braided from braided filaments.

Preferably, the diameter of the braided wires forming the whole tubular grid body is 0.0008-0.002 in, and the total number of the braided wires is 48-144, so that a dense net with higher grid density can be constructed, blood flow in a tumor cavity is effectively blocked, thrombus formation in the tumor is promoted, and the coverage rate of the tumor neck is improved.

The material of the braided wire comprises a shape memory material, and the shape memory material can be a metal material with a shape memory function, such as nickel-titanium (Ni-Ti) alloy, nickel-cobalt-nickel alloy (Ni-Ti-Co), double-layer composite metal wire (Ni-Ti @ Pt) and the like. The material of the woven filament may also be a polymer material with a certain shape recovery capability, such as Polydioxanone (PDO), (lactide-epsilon-caprolactone) copolymer (PLC), polyurethane (PU), polynorbornene amorphous polymer, etc., or a combination of these materials. The braided wire is made of shape memory metal material or polymer material with certain shape recovery capability, so that the whole tubular grid body has the functions of memorizing and recovering the original shape. Preferably, the entire tubular mesh body is woven from developable woven filaments, or the entire tubular mesh body is co-woven from developable woven filaments and non-developable woven filaments. By the design, the whole tubular grid body can be developed under X-rays, the elasticity of the whole tubular grid body is ensured, and the whole tubular grid body has strong recovery capability and the capability of keeping the original shape. The utility model discloses it does not do special restriction to can develop the metal development material of weaving silk, platinum (Pt), platinum iridium (Pt-Ir), au (gold) etc. can select for use for example. The entire tubular mesh may be made from one or a combination of materials. In other aspects, the entire tubular mesh body may be formed of an elastic material or other suitable self-forming material that is capable of expanding into a desired shape upon release from a delivery catheter.

In order to more stably pack within the tumor while still sufficiently covering the neck opening of the tumor, the cross-sectional diameter D of the intermediate mesh body 102 in the deployed state is preferably not less than 1/4 of the maximum outer diameter D of the entire embolic device 100 in the deployed state, and more preferably, the cross-sectional diameter D of the intermediate mesh body 102 in the deployed state is 1/3 to 2/3 of the maximum outer diameter D of the entire embolic device 100 in the deployed state, which is a dimension that does not make the intermediate portion 102 too large or too small; if the intermediate portion 102 is too small, the supporting force is lowered to some extent and the neck opening cannot be covered sufficiently; if the intermediate portion 102 is too large, friction with the walls of the aneurysm is high, which increases resistance to molding.

The maximum outer diameter D of the embolic device 100 in the deployed state can be set according to the size of the aneurysm to be filled. For example, the embolic device 100 optionally has a maximum outer diameter D in the deployed state of 6mm to 32mm, which is a dimension that substantially allows the embolic device 100 to occlude a variety of aneurysms, yet be stably supported within the aneurysm. Here, the maximum outer diameter refers to the maximum radial dimension of the cross section of the entire embolic device 100 in the same projection plane, and as viewed from fig. 1, the maximum outer diameter of the entire embolic device 100 after being orthographically projected in the projection plane parallel to the paper surface direction is the maximum outer diameter D of the entire embolic device 100 in the deployed state. And the maximum outer diameter D of the expanded embolism device 100 is larger than the maximum inner diameter of the tumor cavity, so that the embolism device 100 is supported in the tumor cavity by the self expansion force without displacement. As another example, the diameter d of the tubular mesh body during deployment may be 2mm to 8mm, such as 2mm, 4mm, 6mm or 8mm, and more preferably 4mm to 6mm, this arrangement can ensure that the middle mesh body 102 can cover the neck of the aneurysm after deployment, and the whole embolization device 100 can also be stably supported in the aneurysm without over-stressing the aneurysm wall, and can be easily molded during the plugging process, with good molding stability.

In one embodiment, the proximal mesh body 101 and/or the distal mesh body 103 form no more than one turn of a helical structure in the deployed state.

In one embodiment, the proximal mesh body 101 and/or the distal mesh body 103 form a helix with more than one turn in the deployed state.

Preferably, the proximal mesh body 101 and/or the distal mesh body 103 form a helix of no more than one turn, more preferably less than one turn, in the deployed state.

If the number of spiral turns of the proximal mesh body 101 and/or the distal mesh body 103 exceeds one turn or is equal to one turn, more tumor cavity dividing surfaces can be provided for the embolization device 100, so that the turbulent flow effect of the embolization device 100 is enhanced, and the formation of thrombus in the tumor is facilitated.

If the spiral turns of the far-end grid body 103 are less than one turn, the far end 104 can be in an inner buckling state, and the damage or impact on the tumor wall can be reduced better. Preferably, the distal mesh body 103 forms a helix of not less than 1/2 turn when deployed to ensure the distal end 104 buckles inward, more preferably, forms a helix of 1/2 turn to 1 turn, such as 1/2 turn, 2/3 turn, or 1 turn.

If the number of turns of the proximal mesh 101 is less than one turn, it is beneficial to shorten the proximal length of the embolization device, reduce the kicking of the proximal end 105 (which would cause the delivery catheter to move back and be detrimental to precise embolization), and also to facilitate the inward buckling of the proximal end 105, thereby avoiding damage or impact of the relatively hard proximal end 105 to the tumor wall. Preferably, the proximal mesh body 102 forms a helix with no less than 1/2 turn when deployed to ensure that the proximal end 105 buckles inward, and more preferably forms a helix with 1/2 turn to 1 turn, such as 1/2 turn, 2/3 turn, or 1 turn.

The length of the middle grid body 102 around the aneurysm is preferably 1/2-1 circle when the middle grid body is in an unfolding state, so that enough outer side net surface can be ensured to cover the neck of the aneurysm, enough supporting force can be provided, and the influence on the friction of the aneurysm wall can be reduced. Such as 1/2 turn or 2/3 turn or 1 turn around the aneurysm when the intermediate mesh body 102 is in the deployed state. In the present invention, the length (i.e. arc length) of the planar arc structure of the middle lattice body 102 during the expansion can be set according to the size of the aneurysm neck relative to the aneurysm cavity.

The cross-sectional shape of the entire tubular lattice after expansion is not limited, and includes, but is not limited to, a circular cross-section, such as a flat cross-section, or other regular or irregular shapes. The irregular shape refers to a special-shaped figure other than the axisymmetric and the center-symmetric figure. Preferably, the cross section of the whole tubular mesh body after being unfolded is circular or approximately circular, and at the moment, the cylindrical woven mesh pipe has better supporting force, so that the mesh pipe is not only easy to form in a tumor, but also not easy to displace.

All of the braided wires of the embolic device 100 at the proximal end 105 may be captively held by proximal connector 106, i.e., all of the braided wire filaments at the proximal end 105 are captively held by proximal connector 106. All of the braided wires at the distal end 104 of the embolic device 100 may be captively held by the distal connector 107, i.e., all of the braided wire ends at the distal end 104 are captively held by the distal connector 107. Preferably, the proximal connector 106 and/or the distal connector 107 are made of, include and/or are coated with a metal developing material to enhance visibility of the embolic device 100 at the proximal 105 and/or distal 104 ends.

In one embodiment, in the deployed state, the cross-sectional diameter d of the entire embolic device 100 increases and then decreases from the proximal end to the distal end, or the diameter d of the entire embolic device 100 repeatedly increases and then decreases from the proximal end to the distal end, such that the entire embolic device 100 is configured in a fusiform shape, i.e., a structure with two small ends and a large middle, so as to compress to a smaller size, and further improve the flexibility of the embolic device, further reduce the pushing resistance, and reduce the impact or damage to the tumor wall.

As shown in fig. 1 and 3, the embolic device 100 may be delivered to a 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 the push rod 410 being releasably connected to the proximal end 105 of the embolic device 100, the push rod 410 extending tangentially to the helically shaped helix of the proximal mesh body 101 in the deployed state such that the outer side of the middle mesh body 102 of the embolic device 100 covers the neck opening when the push is released, thereby increasing the metal coverage of the neck opening and preventing herniation of the proximal end 105 of the embolic device 100. The release between the pushing rod 410 and the proximal end 105 may be achieved by, but not limited to, thermal release, electrical release, mechanical release, or hydrolytic release. The push rod 410 functions to push the embolic device 100 out of the delivery catheter, enabling the embolization device 100 to be packed within the aneurysm 200.

In practice, 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 intravascularly adjacent to the aneurysm 200. Then, the embolic device 100 is inserted into the lumen of the delivery catheter, and with the aid of the push rod 410, the embolic device 100 can be moved from within the delivery catheter to outside the delivery catheter so that the embolic device 100 is guided and positioned within the aneurysm 200 lumen.

Next, the present invention will be described in further detail with reference to the following specific embodiments in conjunction with the accompanying drawings.

< first embodiment >

Fig. 1 shows a view of the embolic device 100 of the present invention in a deployed state according to a first preferred embodiment, and fig. 2 shows a view of the embolic device 100 of the present invention in a deployed state to occlude an aneurysm 200 according to a first preferred embodiment.

As shown in FIGS. 1 and 2, in one embodiment of the invention, in the deployed state, the distal mesh body 103 of the embolization device 100 forms a 1/2 turn helix, the middle mesh body 102 forms a planar arc (e.g., circular arc) 2/3 of a turn around the aneurysm 200, and the proximal mesh body 101 forms a 1/2 turn helix.

When implanted in vivo, the distal mesh body 103 may be guided during the initial stages of packing the aneurysm 200; the middle grid body 102 sequentially releases and fills the aneurysm 200 under the guidance of the distal grid body 103 until the external side surface of the middle grid body covers the neck of the aneurysm, so as to form a continuous dense-network covering surface; the proximal mesh 101 then continues to be released until the entire embolic device 100 is pushed out of the delivery catheter, completing the tamponade.

In this embodiment, the proximal grid 101 and the distal grid 103 are both bent toward the middle grid 102, so that the proximal end 105 and the distal end 104 are in an inside buckling state in the tumor cavity, and the tumor wall is prevented from being damaged or impacted by the relatively hard distal and proximal ends (e.g., including the proximal connecting element 106 and the distal connecting element 107); the middle mesh 102 is supported in the tumor cavity, and the auxiliary support of the distal mesh 103 and the proximal mesh 101 is added, so that the whole embolization device 100 can be stably packed in the tumor cavity.

In this embodiment, the embolization device 100 is approximately axially symmetric in the deployed state, i.e. the proximal mesh 101 and the distal mesh 103 are approximately symmetrically disposed about the central axis of the middle mesh 102, and at this time, the entire embolization device 100 has good support, and it is ensured that the entire device is stably packed in the tumor.

< example II >

Fig. 3 shows a view of the embolic device 100 according to the second preferred embodiment of the present invention in a deployed state. In the second embodiment of the present invention, as shown in fig. 3, in the deployed state, the distal mesh body 103 of the embolization device 100 forms a spiral structure with 1 turn, the middle mesh body 102 forms a planar arc structure with a length of 1 turn or approximately 1 turn around the aneurysm, and the proximal mesh body 101 forms a spiral structure with 1 turn.

When implanted in vivo, the distal mesh body 103 may be guided during the initial stages of packing the aneurysm 200; the middle grid body 302 sequentially releases the stuffing under the guidance of the far-end grid body 103 until the outer side surface of the middle grid body covers the neck of the tumor to form a continuous dense-network covering surface; the proximal mesh 101 then continues to be released until the entire embolic device 300 is pushed out of the delivery catheter, completing the tamponade.

In this embodiment, the distal mesh body 103 and the proximal mesh body 101 are parallel to (including tangent to) the tumor wall in the tumor cavity, so as to avoid the relatively hard distal and proximal ends from damaging or impacting the tumor wall; the middle mesh 102 is supported in the tumor cavity, and the auxiliary support of the distal mesh 103 and the proximal mesh 101 is added, so that the whole embolization device 100 can be stably packed in the tumor cavity.

In this embodiment, the embolization device 100 is also approximately axisymmetric in the deployed state, i.e., the proximal mesh 101 and the distal mesh 103 are approximately symmetrically disposed about the central axis of the middle mesh 102, and thus the entire embolization device 100 has good support properties, and can ensure that the entire device is stably embolized within a tumor.

Compared with the first embodiment, the proximal mesh body 101 and the distal mesh body 103 in the second embodiment have more spiral turns, so that more tumor cavity dividing surfaces can be provided, and the turbulent flow effect of the embolization device 100 is enhanced.

< example three >

Fig. 4 shows a view of the embolic device 100 according to the third preferred embodiment of the present invention in a deployed state, and fig. 5 shows a view of the embolic device 100 according to the third preferred embodiment of the present invention in a deployed state occluding an aneurysm 200.

In a third embodiment of the invention, as shown in fig. 4 and 5, in the deployed state, the distal mesh body 103 of the embolization device 100 forms a 1-turn helical structure, the middle mesh body 102 forms a planar arc structure with a length of 1 turn or nearly 1 turn around the aneurysm, and the proximal mesh body 101 forms a 1/2-turn helical structure.

When implanted in vivo, the distal mesh body 103 may be guided during the initial stages of the aneurysm 200 packing; the middle grid body 102 is sequentially released and stuffed under the guidance of the far-end grid body 103 until the outer side surface of the middle grid body covers the neck of a tumor to form a continuous dense-network covering surface; while the proximal mesh 101 continues to be released until the entire embolic device 100 is pushed out of the delivery catheter, completing the tamponade.

In this embodiment, the distal grid 103 makes the distal end 104 parallel to (including tangent to) the tumor wall in the tumor cavity, and the proximal grid 101 makes the proximal end 105 in an inside-buckled state in the tumor cavity, so as to avoid the relatively hard distal and proximal ends from damaging or impacting the tumor wall; the middle mesh 102 is supported in the tumor cavity, and the auxiliary support of the distal mesh 103 and the proximal mesh 101 is added, so that the whole embolization device 100 can be stably packed in the tumor cavity.

In this embodiment, the embolic device 100 is non-axisymmetric in the deployed state, i.e., the proximal mesh 101 and the distal mesh 103 are asymmetrically disposed about the central axis of the middle mesh 102.

Compared with the second embodiment, the proximal mesh body 101 in the third embodiment is shorter, because once the middle mesh body 102 is covered on the tumor neck, the proximal mesh body 101 is difficult to push in the tumor cavity, the length of the proximal mesh body 101 is shortened, the tube kicking phenomenon of the proximal end 105 of the embolism device 100 can be reduced, and the proximal end 105 can be buckled inwards, so that the tumor wall is prevented from being damaged by the relatively hard proximal end; the middle mesh 102 is supported in the tumor cavity, and the auxiliary support of the distal mesh 103 and the proximal mesh 101 are added, so that the whole embolization device 100 can be stably packed in the tumor cavity.

In conclusion, it should be understood that the utility model discloses rely on the dense net face in the outside of the grid body in the middle of the embolism device to cover the tumor neck, realize the effect of the interior vortex of the tumor cavity of device, and then realize the shutoff of aneurysm. Especially, the net body of far and near end when the embolism device becomes certain angle (not in coplanar promptly) with middle net bodily form, makes the laminating tumour wall that the embolism device can be better fix, prevents that the embolism device from taking place the aversion to the spiral net bodily form of far and near fills in the tumour intracavity, cuts apart tumour intracavity space, can improve the vortex effect in the tumour intracavity in the shutoff of tumour neck, promotes thrombosis in the aneurysm. In more detail, the whole embolization device is simple to release, the dependence on the embolization experience of the personal aneurysm of a doctor in the operation process can be reduced, and the operation time is shortened; the middle grid body of the whole embolism device can block the aneurysm, the operation is flexible, the two ends and the middle grid body are not in the same plane, the middle grid body is anchored on the two surfaces of the inner side of the aneurysm wall, stronger supporting force is provided, and the embolism device is prevented from shifting; the middle grid body can provide a continuous dense-net covering surface at the tumor neck, and meanwhile, no additional riveting points influence the blood flow at the tumor neck, so that the endothelialization process can be more uniform; the whole embolism device is completely positioned in the aneurysm, so that the use of dual antiplatelet drugs can be avoided; the entire embolic device can be gradually packed by radial length, facilitating delivery through a delivery catheter with a smaller inner diameter, and thus more lesion sites can be reached; the whole embolism device increases the internal turbulence effect while improving the tumor neck coverage, can promote the formation of thrombus in the tumor, and accelerates the embolism of the aneurysm.

Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the present invention and its equivalent technology, the present invention is also intended to include such modifications and variations.

Claims (12)

1. An embolization device made of a tubular mesh body and adapted to occlude a target lumen, wherein the embolization device has a deployed state and a compressed state and is switchable between the deployed state and the compressed state;

the embolism device comprises a near-end grid body, a middle grid body and a far-end grid body which are sequentially connected along the axis of the embolism device; the proximal mesh body and the distal mesh body both form a helical structure when in the expanded state; the intermediate mesh body forms a planar arc structure that does not exceed one turn around the length of the target cavity in the deployed state and is used to cover the opening of the target cavity.

2. The embolization device of claim 1, wherein 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 being disposed on the same side or different sides of the plane in which the intermediate mesh body is located, in the expanded state.

3. The embolization device of claim 1 or 2, wherein the distal lattice body forms no more than one turn of the helical structure in the deployed state and/or the proximal lattice body forms no more than one turn of the helical structure in the deployed state.

4. The embolization device of claim 3, wherein the distal lattice body forms a helix of 1/2 to 1 turn in the deployed state, and/or the proximal lattice body forms a helix of 1/2 to 1 turn in the deployed state.

5. The embolization device of claim 1 or 2, wherein the intermediate mesh body has a length of 1/2 to 1 turn around the target cavity in the deployed state.

6. The embolic device of claim 1 or 2, wherein the cross-sectional diameter of the intermediate mesh body in the deployed state is no less than 1/4 of the maximum outer diameter of the entire embolic device in the deployed state.

7. The embolization device of claim 6, wherein 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.

8. The embolization device of claim 1 or 2, wherein the embolization device is in an axisymmetric configuration in the deployed state, the proximal mesh and the distal mesh being symmetrically disposed about a central axis of the intermediate mesh, the central axis being for passing through the opening of the target cavity.

9. The embolization device of claim 1 or 2, wherein in the deployed state the cross-sectional diameter of the embolization device increases and then decreases from the proximal end to the distal end, or wherein the cross-sectional diameter of the embolization device repeatedly increases and then decreases from the proximal end to the distal end.

10. The embolization device of claim 1 or 2, wherein the embolization device is integrally or integrally braided from braided filaments.

11. The embolization device of claim 10, wherein the wire diameter of the weaving wire is 0.0008-0.002 in, the total number of weaving wires is 48-144, the weaving wires are made of shape memory material and/or the weaving wires are developable.

12. The embolization device of claim 10, wherein all of the braided wires at the distal end of the embolization device are captively secured by a distal connector and all of the braided wires at the proximal end of the embolization device are captively secured by a proximal connector, and wherein the distal connector and/or the proximal connector are made of a metal visualization material.

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