CN217285931U - Embolization device and embolization system - Google Patents

Abstract

The utility model relates to an embolism device and embolism system, the embolism system includes push rod and embolism device, the distal end of push rod and the releasable connection of the fixed knot structure of embolism device, the embolism device includes the distal end grid body, fixed knot structure and the near-end grid body that connect gradually axially, distal end grid body and near-end grid body are made by the net pipe that both ends are closed, and can twist relatively between distal end grid body and the near-end grid body; wherein: the embolic device has at least a compressed state and a deployed state and is switchable between the compressed state and the deployed state; so the configuration can reduce the damage to the tumor wall, avoid the risk of proximal hernia entering tumor-carrying blood vessel, and is suitable for hemangiomas of different specifications, and the application range is enlarged.

Description

Embolization device and embolization system

Technical Field

The utility model relates to the technical field of medical equipment, in particular to embolism device and embolism system.

Background

Intracranial aneurysm is pathological protrusion of intracranial arterial wall, the incidence rate is 5% -10%, MRA research shows that the incidence rate of unbroken aneurysm of 35-75 years old adults in China is about 7.0%. Among them saccular aneurysms are the most common type of aneurysm, accounting for 80% to 90% of all intracranial aneurysms, and are the most common cause of non-traumatic subarachnoid hemorrhage (SAH), which, depending on the severity of the hemorrhage, may lead to permanent neurological deficits or death. The blood vessel interventional therapy can avoid brain tissues to directly reach lesions by virtue of the characteristics of small surgical trauma and the like, and becomes a mainstream means for treating intracranial aneurysms in recent years. There are two main modes of vascular interventional therapy, namely, coil embolization and blood flow guidance.

Coiled coil embolization relies on the delivery of a preformed coil from a catheter into the aneurysm for filling, causing a gradual stasis of blood flow within the lumen of the aneurysm, thereby causing clot formation and excluding further inflow of blood, thereby preventing further deployment of the aneurysm. When embolization is successful, the thrombus may eventually become covered with a layer of endothelial cells, reforming the inner vessel wall. However, not all coil embolization procedures are successful, which may lead to aneurysm recanalization, and may require the implantation of additional devices, such as auxiliary stents and blood flow guides. The use of multiple devices increases the time of the procedure, the cost of the treatment, and the likelihood of adverse events. And the spring ring embolization efficiency is low, the requirements on the skill and experience of doctors are high, the risk of herniated aneurysm exists when the spring ring embolization device is used alone, and the risk of ischemic complications can be increased when the spring ring embolization device is matched with other devices.

The application of the blood flow guiding device improves the long-term curative effect of large and huge aneurysms and greatly reduces the use of spring rings. The computer hemodynamics simulation analysis shows that when the metal coverage rate reaches 30-50%, the blood flow in the aneurysm cavity can be obviously reduced. However, the use of blood flow directing devices has led patients to rely on dual anti-platelet therapy for long periods of time, with the risk of bleeding complications following surgery; while at the same time risking occlusion of the branch vessel with a flow directing device for a bifurcation aneurysm. In addition, there is a risk of delayed rupture following treatment of a portion of a large aneurysm with a blood flow directing device alone.

At present, some novel disposable embolization devices are prepared from shape memory materials, are preformed and shaped, are conveyed through a catheter, are pushed out from a sheath tube after reaching a specific position, and are self-expanded to restore to the preformed shape, so that the purpose of plugging aneurysm is achieved. For example, a first embolization device is provided, which is a spherical or cylindrical dense-net device with riveted points at two ends, the whole device is expanded in a tumor cavity, and aneurysm treatment is realized by covering a tumor neck with a near-end dense net. The second embolism instrument is provided, a developing wire and the peripheral self-expanding memory alloy jointly form a three-dimensional net structure, the three-dimensional net structure can be released and recovered through the catheter like a spring ring, and the three-dimensional net structure can be spherical when being filled in a tumor, so that the turbulent flow effect is further exerted. A third embolic device is also provided, woven from a double layer of nitinol, and operates on a similar principle to the first embolic device, but without a rivet point at the distal end of the device. The fourth embolism instrument is formed by weaving double-layer memory alloy, is in a disc shape without limitation, is in a tulip shape limited by 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 first type of embolic device is designed with a proximal and distal anchor point to provide an axisymmetric device orientation for its coverage of the neck of the aneurysm, primarily for treatment of bifurcated wide-diameter aneurysms, and particularly for regular aneurysms. And if the first embolism apparatus is designed to be single spherical, the release length of the device is long, the friction extrusion to the tumor wall is large in the release process, and the far-end rivet point has impact effect on the tumor wall, so that the tumor wall is easy to break, the aneurysm bleeds, and in some cases, the near-end rivet point is extruded by the tumor wall and hernias into the parent artery, so that the endothelialization process of the tumor neck is influenced. In addition, the first embolic device is typically a single sphere or cylinder, with large contact area but insufficient support, poor long-term stability in the tumor cavity, and easy device displacement. The second embolism apparatus is shaped into a three-dimensional net structure by a plurality of sheet nets, is similar to a sphere, and has the defects of poor forming stability of the apparatus in a tumor, difficult recovery to a preset shape, influence on filling effect, and complex operation because of the large friction force between the three-dimensional net structure and the tumor wall. The third embolic device is basically similar to the first embolic device in working principle, so the same problem exists, although the distal rivet point is not provided, the tumor neck is covered with orientation by the proximal rivet point, and the tumor wall extrudes the hernia into the parent artery to influence the endothelialization process. And the proximal end rivet point of the fourth embolization device is also easy to be extruded by the tumor wall to enter the parent artery, so that the embolization device is suitable for the apical aneurysm, 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 device is low in efficiency. In addition, the internal cavity of the embolism instrument is large, the stability of the embolism instrument is influenced under the action of water hammer of blood, and meanwhile, the internal cavity has small resistance to the flow of blood in the aneurysm, so that the formation of thrombus in the aneurysm is not facilitated.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide an embolism device and embolism system can reduce the damage to the tumor wall, avoids the near-end hernia to go into the hemangioma of year tumor to be applicable to the hemangioma of more specifications, enlarge range of application.

In order to achieve the above object, the present invention provides an embolization device for embolizing hemangioma, comprising a distal mesh body, a fixing structure and a proximal mesh body, which are axially connected in sequence, wherein the distal mesh body and the proximal mesh body are both made of mesh tubes with two closed ends, and the distal mesh body and the proximal mesh body can be twisted relatively; wherein: the embolic device has at least a compressed state and a deployed state and is switchable between the compressed state and the deployed state.

Optionally, after the embolic device is deployed, the distal mesh is of an ellipsoid structure or a cylinder structure, the proximal mesh is of an ellipsoid structure or a cylinder structure, and the long axis of the distal mesh and the long axis of the proximal mesh are both intersected with the longitudinal axis of the embolic device.

Optionally, the maximum outer diameter of the proximal mesh body is greater than or equal to the total longitudinal height of the embolic device after deployment.

Optionally, the maximum outer diameter of the distal mesh body is less than or equal to the maximum outer diameter of the proximal mesh body after deployment of the embolic device.

Optionally, the largest outer diameter of the distal mesh is greater than or equal to 1/2 of the largest outer diameter of the proximal mesh after deployment of the embolic device.

Optionally, the maximum outer diameter of the proximal mesh body is between 3mm and 25mm after deployment of the embolic device.

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

Optionally, the longitudinal height of the distal mesh body is 1/3-1/2 of the total longitudinal height of the embolic device after deployment.

Optionally, one end of the fixing structure is fixedly connected to the mesh surface of the proximal mesh body, and the other end of the fixing structure is fixedly connected to the mesh surface of the distal mesh body.

Optionally, the fixed structure is developable, and/or the fixed structure is an elastic structure.

To achieve the above objects, the present invention also provides an embolic system comprising a push rod and any of the embolic devices, the distal end of the push rod being releasably connected to the fixation structure of the embolic device.

Compared with the prior art, the utility model discloses an embolism device and embolism system has at least one in following advantage:

first, the embolization device disclosed in the present invention can restore the far-end mesh to the expanded state before the near-end mesh in the releasing process due to the existence of the middle fixing structure, and is not affected by the near-end mesh which is not released, so that the releasing length of the embolization device can be effectively shortened; due to the configuration, on one hand, the extrusion friction of the embolism device on hemangioma in the releasing process is reduced, the operation safety is improved, on the other hand, the limitation of the length-diameter ratio of the hemangioma to the selection of the embolism device is reduced, so that the embolism device can be suitable for the hemangioma with larger size and different positions, and in addition, the relative torsion can be generated between the near-end grid body and the far-end grid body, so that the embolism device can be suitable for the hemangioma with different forms;

second, the utility model discloses an embolism device is because the distal end grid body comprises both ends confined network management, make whole distal end grid body not have the riveting point of protrusion wire side, whole distal end is even dense wire side, then, can effectively disperse the effort to the tumor wall behind the distal end grid body contact tumor wall, reduce the damage of embolism device to hemangioma, reduce hemangioma risk of breaking, and in the release process of proximal end grid body, the distal end grid body also can cushion the effort of whole embolism device to hemangioma, further reduce hemangioma risk of breaking;

thirdly, the utility model discloses an embolism device is also by both ends confined net pipe composition because the near-end net body for whole near-end net body does not have the rivet point of protrusion wire side, and whole near-end also is even dense wire side, can effectively cover the tumor neck through near-end dense wire side, reduces the blood flow volume in flowing into or flowing out hemangioma, promotes the thrombosis, and then promotes the healing of hemangioma, promotes the endothelialization process of tumor neck department;

fourthly, the embolism device disclosed by the utility model is simpler to release, can reduce the dependence on the embolism experience of the personal hemangioma of a doctor in the operation process, and can reduce the operation time; in addition, the near-end grid body and the far-end grid body form a multi-layer dense-net structure in the tumor cavity, so that the embolization density can be improved, the number of instruments required by the operation is reduced, the tumor neck coverage is improved, the internal turbulence effect is increased, the formation of thrombus in the tumor can be promoted, and the embolization of hemangioma is accelerated; in addition, the embolism device is completely positioned in hemangioma, so that the use of dual antiplatelet drugs can be avoided.

Drawings

Features, properties and advantages of the method of implementation of the invention and the related embodiments will be described by combining the following drawings, wherein:

FIG. 1 is a front view of an embolization device according to a first preferred embodiment of the invention;

FIG. 2 is a top view of an embolization device according to a first preferred embodiment of the present invention, looking down in a distal to proximal direction;

FIG. 3 is a state diagram of the embolic device of the first preferred embodiment of the present invention during release;

FIG. 4 is a view of the embolization device of the first preferred embodiment of the present invention fully deployed within an aneurysm;

FIG. 5 is a cross-sectional view of the proximal mesh surface of the embolization device according to the first preferred embodiment of the present invention covering the cervical orifice;

fig. 6 is a front view of an embolization device according to a second preferred embodiment of the present invention;

fig. 7 is a front view of an embolization device according to a third preferred embodiment of the invention.

[ reference numerals describe below ]:

10-an embolic device; 11-a proximal mesh body; 12-a distal mesh body; 13-a fixed structure; 21-a push rod; 31-a microcatheter; 40-aneurysm; 41-tumor neck; 50-parent artery; l-the longitudinal height of the embolic device; d1 — maximum outer diameter of distal mesh body; d2-maximum outer diameter of proximal mesh body.

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. It should be noted that the drawings are in simplified form and are not to precise scale, and are provided for convenience and clarity in order to facilitate the description of the embodiments of the present invention.

As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. As used in this specification, the term "plurality" is generally employed in a sense including two or more, unless the content clearly dictates otherwise. As used in this specification, the term "plurality" is generally employed in its sense including a quantity that is indefinite, unless the content clearly dictates otherwise. As used in this specification, unless otherwise specified, the terms "proximal" and "distal" refer to the position of an embolic device and/or portions of an embolic device relative to an operator along the longitudinal axis of the embolic device. Generally, "proximal" refers to the end closer to the operator, and "distal" generally refers to the end further from the operator. As used herein, "longitudinal" refers to a direction perpendicular to the cross-sectional area of the neck opening, i.e., perpendicular to the cross-sectional area of the tumor cavity; "transverse" means a direction parallel to the cross-section of the neck opening, i.e. parallel to the cross-section of the tumor cavity.

The core of the utility model is to disclose an embolization device, which is mainly used for treating intracranial saccular aneurysm, including bifurcation aneurysm and side wall aneurysm. It should be understood, however, that the embolic devices of the present disclosure are not limited to aneurysms, but may also be hemangiomas occurring in other blood vessels.

The utility model discloses a embolism device is a dense net structure of multilayer, can realize the shutoff of hemangioma tumour neck in hemangioma, does not get into and carries the tumour blood vessel, need not to take dual resistance for a long time. The utility model discloses a near-end of embolism device does not have the riveting point, but can cover the even dense dictyosome of tumor neck, plays the vortex effect, reduces the impact of blood flow in to the tumor sac, promotes the formation of thrombus in the tumor, and then realizes the purpose of hemangioma embolism. The utility model discloses a embolism device can effectively shorten release length, reduces the friction extrusion to the tumor wall among the release process, promotes the operation security, and the distal end also does not have the riveting point with one side of tumor chamber contact simultaneously, can further reduce the damage to hemangioma.

The utility model discloses an embolism device accessible microcatheter is carried, has compression state and expansion device at least to can switch between compression state and expansion state. Typically, the embolization device is compressed within the microcatheter and returns to the deployed state after being pushed out of the microcatheter.

The invention will be described in more detail below with reference to the accompanying drawings and preferred embodiments. In the following embodiments, features of the embodiments can be supplemented with each other or combined with each other without conflict. For the sake of simplicity, in the following description it is assumed that the aneurysm is an intracranial aneurysm, and the person skilled in the art should be able to modify the following description, with appropriate modifications in detail, for cases other than an intracranial aneurysm.

< example one >

The first preferred embodiment of the present invention provides an embolic device 10, as shown in fig. 1-5. The embolism device 10 comprises a near-end grid body 11, a fixed structure 13 and a far-end grid body 12 which are sequentially connected in the axial direction; the far-end mesh body 12 and the near-end mesh body 11 are both made of mesh tubes with two closed ends, so that the whole embolism device 10 has no rivet point at the far end and no rivet point at the near end, and many problems caused by rivet points at the far end and the near end are avoided. The rivet point is generally understood to be a binding end of a plurality of braided wires. In the prior art, a reticular braided body usually has a proximal end and a distal end, the bunched portion is an end structure formed by gathering and constraining braided wires together, and the bunched portion of the braided wires generally protrudes towards the outside of the braided body to form a tip (i.e. a rivet point), so that the aneurysm wall is easily impacted and pressed, and the rupture of the aneurysm is caused.

Therefore, the embolism device 10 of this embodiment does not have the indent structure that sets up for hiding the riveting point, and not only the dense mesh surface contact tumor top of accessible distal end increases area of contact, improves stability to reduce the impact to the tumor wall, the dense mesh surface of accessible proximal end covers the tumor neck moreover, increases the metal coverage rate of tumor neck, has avoided the problem that current proximal end riveting point hernia goes into the tumor-carrying blood vessel simultaneously. It should be further understood that the mesh tube with closed ends refers to a method of centripetal knitting, so that the knitting filaments are in a central concentrated state, for example, the near-end mesh surface of the near-end mesh body 11 is formed by converging the knitting filaments at the closed ends of the mesh tube toward the center, so as to form a uniform and dense mesh surface, for example, the far-end mesh surface of the far-end mesh body 12 is also formed by converging the knitting filaments at the closed ends of the mesh tube toward the center, and also has a uniform and dense mesh surface. More specifically, because embolism device 10 all does not have the riveting point at near-end and distal end, reduced the injury to the aneurysm wall, prevented the impact of distal end riveting point to the aneurysm wall, reduced the ruptured risk of aneurysm wall, and also avoided near-end riveting point to receive the easy problem of the easy hernia of carrying the parent artery of the extrusion of aneurysm wall, avoided the influence to the process of endothelialization, the cover of the neck of the tumor of the device does not have the orientation problem simultaneously, all can be suitable for regular and irregular aneurysm, and also can be suitable for top aneurysm or lateral wall aneurysm.

In addition, due to the arrangement of the fixing structure 13, the distal grid body 12 and the proximal grid body 11 can be twisted relatively, so that the two can be coaxial or non-coaxial, and therefore, the device is not limited by the orientation of the neck opening and has a wider application range. It should also be understood that the fixing structure 13 is not overlapped with the proximal mesh body 11 and the distal mesh body 12 in the longitudinal direction, that is, the fixing structure 13 is disposed between the proximal mesh body 11 and the distal mesh body 12, so as to fix the two mesh bodies and enable the two mesh bodies to be twisted relatively, and the twisting angle can be larger, so as to be suitable for aneurysms with different shapes. The size of the fixing structure 13 is much smaller than that of any one of the grids, so as to provide elasticity and ensure a certain connection strength, and those skilled in the art can set the size of the fixing structure 13 as required, for example, the fixing structure 13 can be set to a length of about 0.5mm to 2.0 mm.

The fixing structure 13 is usually fixed by gluing to the mesh body, one end of the fixing structure 13 is fixed by gluing to the distal mesh surface of the proximal mesh body 11, and the other end of the fixing structure 13 is fixed by gluing to the proximal mesh surface of the distal mesh body 12. The structure of the fixing structure 13 is not limited in the application, and the fixing structure can be an elastic structure such as an elastic tube, an elastic sheet and a spring. Further, the fixing structure 13 can be developed, such as a developing ring or a developing spring.

Further, the preferred embodiment of the present invention also provides an embolic system comprising a push rod 21 and an embolic device 10, wherein the distal end of the push rod 21 is releasably connected to the fixation structure 13. Thus, the embolic device 10 can be delivered through the microcatheter 31 and into the aneurysm via the push rod 21 for release and retrieval of the embolic device. Can be released and recovered for a plurality of times, reduces the operation difficulty, avoids the occlusion of the parent aneurysm and the branch when effectively embolizing the aneurysm, can also effectively avoid the displacement of the device, reduces the displacement risk after the aneurysm is stuffed, and can treat the aneurysms in different positions, different shapes and different sizes.

The push rod 21 can be disengaged from the fixed structure 13. The distal end of the pushing rod 21 has a releasing region, and the releasing can be achieved after the embolism device 10 reaches a specific position, and the releasing manner between the pushing rod 21 and the fixed structure 13 can be heating releasing, electrical releasing, mechanical releasing or hydrolytic releasing in the prior art, which is not limited in this respect. When the device is not released properly, it can be recovered again and then repositioned and released.

Referring to fig. 3, during the delivery process, the microcatheter 31 enters the parent artery 50, the distal end of the microcatheter 31 is aligned with the aneurysm 40, the embolization device 10 is delivered through the microcatheter 31, and the embolization device 10 is pushed out of the distal end of the microcatheter 31 by the pushing rod 21, during the release process, the distal mesh 12 is pushed out of the tumor cavity to be released first, and then the proximal mesh 11 is pushed out of the tumor cavity to be released. After the embolization device 10 is completely released, the pushing rod 21 is separated from the fixing structure 13, and finally, both the pushing rod 21 and the microcatheter 31 are withdrawn from the body, thereby completing embolization.

Fig. 4 and 5 illustrate the embolization device 10 in a packed state within an aneurysm 40. As shown in fig. 4 and 5, the entire embolization device 10 completely covers the tumor neck 41 through the proximal mesh surface of the proximal mesh body 11, so that a continuous covering surface with high metal coverage and high mesh density can be provided at the tumor neck 41, and the plugging effect is good. And the near-end grid body 11 and the far-end grid body 12 form a multilayer dense net in the tumor cavity, so that the turbulent flow effect is good, the thrombosis in the tumor can be accelerated, and the endothelialization process is accelerated. In addition, the embolic device 10 has a smaller axial length after release, making the device adaptable to larger sized aneurysms.

The utility model discloses do not have special restriction to the shape after near-end net body 11 and the expansion of distal end net body 12, as long as the net face is smooth not have the arch can. It is understood that the expanded shape of the proximal mesh 11 and the distal mesh 12 includes, but is not limited to, an ellipsoid or a cylinder. Preferably, the proximal mesh body 11 and the distal mesh body 12 are configured in an expanded shape having a transverse dimension greater than a longitudinal dimension to accommodate the packing of larger sized aneurysms. In this embodiment, after deployment of the embolic device 10, the distal lattice 12 and the proximal lattice 11 are each ellipsoidal structures, each having a major axis length that is the transverse dimension (i.e., the maximum outer diameter) and a minor axis length that is the longitudinal dimension (i.e., the longitudinal height).

In some embodiments, the maximum outer diameter D1 of the distal mesh body 12 may be equal to the maximum outer diameter D2 of the proximal mesh body 11 after deployment of the embolic device 10, or the maximum outer diameter D1 of the distal mesh body 12 may be smaller than the maximum outer diameter D2 of the proximal mesh body 11, which may be suitable for larger aneurysms. Preferably, the maximum outer diameter D1 of the distal mesh body 12 is greater than or equal to 1/2 of the maximum outer diameter of the proximal mesh body 11, so as to ensure sufficient support and stability of the entire device. In this embodiment, as shown in FIG. 1, the maximum outer diameter D1 of the distal mesh body 12 is equal to the maximum outer diameter D2 of the proximal mesh body 11, and the entire embolic device 10 can be used in smaller sized aneurysms.

The maximum outer diameter D2 of the proximal mesh body 11 may be set to be generally 3mm to 25mm after deployment of the embolic device 10, according to clinical requirements, so that the embolic device 10 may be adapted to aneurysms of different sizes. In addition, each mesh pipe is usually woven by weaving yarns, preferably, the yarn diameter of the weaving yarns is 0.0008-0.002 in, and the number of the weaving yarns is 48-144, so as to form a compact net and ensure better filling effect. Any one grid body can be formed by shaping the net pipe in a mould, and then the two grid bodies are fixedly connected by a fixing structure 13.

In some embodiments, the longitudinal overall height L of the embolic device 10 after deployment of the embolic device 10 is less than or equal to the maximum outer diameter D2 of the proximal mesh body 11. Preferably, the total longitudinal height L of the embolic device 10 is less than the maximum outer diameter D2 of the proximal mesh body 11 to accommodate larger aspect ratio aneurysms. In this embodiment, as shown in FIG. 1, the total longitudinal height L of the occluding device 10 is equal to the maximum outer diameter D2 of the proximal mesh body 11.

In some embodiments, the longitudinal height of the distal lattice 12 is 1/3-1/2 of the total longitudinal height L of the embolic device 10 after deployment, i.e., the distal lattice 12 cannot be too high, which would increase the release length, decrease the safety of the procedure, and would not facilitate fitting wide-neck aneurysms with larger length to diameter ratios. And so arranged, it is also advantageous to increase the transverse dimension of the proximal mesh body 12 to increase neck-opening coverage.

In this embodiment, as shown in fig. 1, after deployment of the embolic device 10, the longitudinal height of the distal mesh body 12 is 1/2 of the total longitudinal height L of the embolic device 10.

Further, the mesh tube may be woven from braided filaments of elastic or superelastic material. For example, the wire material with shape memory performance can be woven, and the wire material comprises a metal material with shape memory function, such as one or more of nickel-titanium (Ni-Ti) alloy, nickel-titanium-cobalt (Ni-Ti-Co) alloy, double-layer composite metal wires (Ni-Ti @ Pt) and the like; polymer materials with certain shape recovery capability can also be selected, such as one or more combinations of Polydioxanone (PDO), (lactide-epsilon-caprolactone) copolymer (PLC), Polyurethane (PU), polynorbornene amorphous polymer and the like; the shape memory material can also be formed by mixing and weaving a shape memory material and metal wires (Pt, Pt-Ir and the like) with good developing property, and can also be formed by weaving composite wires (DFT) of the shape memory material and the developing material. Composite wire (DFT) herein refers to a sheath comprising a core wire and a sheath covering the core wire, the core wire being made of a material including, but not limited to, one or an alloy of platinum, iridium, gold, silver, tantalum, and tungsten, and the sheath being made of a material including, but not limited to, one or a combination of nickel-titanium alloy, nitinol, stainless steel, cobalt-chromium alloy, and nickel-cobalt alloy. Thus, the material of the dense mesh allows the device to deform to be constrained within the microcatheter in a low profile configuration and then return to a preset deployed configuration upon release from the microcatheter. In other embodiments, the dense mesh may be formed of other suitable self-forming materials that are capable of returning to a desired shape upon release of the microcatheter 31.

< example II >

In this embodiment, as shown in FIG. 6, after the embolic device 10 is deployed, the distal mesh 12 is cylindrical and the proximal mesh 11 is still ellipsoidal. The following description mainly deals with differences from the first embodiment, and please refer to the first embodiment for the same.

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

It should be appreciated that the embolic device 10 of the present embodiment can effectively shorten the axial release length of the device while ensuring that the proximal mesh surface covers the tumor neck, and the lateral dimension of the proximal mesh surface is larger, which can better cover the tumor neck, maintain the stability of the device, and is more suitable for wide-necked aneurysms.

< example three >

In this embodiment, as shown in FIG. 7, after the embolic device 10 is deployed, the distal mesh 12 remains in an ellipsoidal configuration while the proximal mesh 11 remains in a cylindrical configuration. The following description mainly deals with differences from the first embodiment, and please refer to the first embodiment for the same.

In this embodiment, after the embolic device 10 is deployed, the maximum outer diameter D1 of the distal mesh body 12 is 1/2 of the maximum outer diameter D2 of the proximal mesh body 11, and the maximum outer diameter D1 of the distal mesh body 12 in the first embodiment is equal to the maximum outer diameter D2 of the proximal mesh body 11. In addition, after the embolic device 10 of the present embodiment is deployed, the total axial length L is equal to the outer diameter D2 of the proximal mesh body 11, which is the same as the first embodiment. In addition, after the embolic device 10 of the present embodiment is deployed, the longitudinal height of the distal mesh body 12 is 1/3 of the total longitudinal height L of the embolic device, while the longitudinal height of the distal mesh body 12 of the first embodiment is 1/2 of the total longitudinal height L of the embolic device 10.

It can be understood that embolism device 10 of this embodiment can also effectively shorten the axial release length of device when guaranteeing that the end face covers the tumor neck near, and the horizontal size of near-end wire side is bigger, the more big aneurysm of cover tumor neck that can be better, holding device's stability, more be applicable to the major diameter ratio.

In other embodiments, the proximal mesh body 11 and the distal mesh body 12 may be both cylindrical structures.

To sum up, the utility model discloses an embolization device is because the existence of middle fixed knot structure, in the release process, the distal end grid body can resume to the expansion state at first, effectively shortens the release length of whole embolization device, not only reduces the extrusion friction of embolization device to the aneurysm, but also reduces the restriction that aneurysm draw ratio was selected to embolization device, makes it be applicable to bigger aneurysm size to and in the near-end release process, the distal end grid body also can buffer the effort of device to the aneurysm; meanwhile, the far end is not provided with a riveting point but is an even and dense net surface, the center of the net surface is formed by arranging the closed ends of the net pipes in a centripetal manner, and the acting force on the tumor wall can be effectively dispersed after the net surface contacts the tumor wall, so that the damage of the embolization device to the aneurysm is reduced, and the rupture risk of the aneurysm is reduced. The near end has no rivet point, so that the nearest end surface is a nearly horizontal uniform dense mesh surface, can effectively cover the tumor neck and promote the endothelialization process at the tumor neck.

It is also understood that the reduction in the release length of the occluding device may allow the occluding device to be used not only in bifurcation aneurysms (i.e., apical aneurysms) but also in side wall aneurysms. In addition, the push rod can be detachably connected with the middle fixing structure of the embolization device, so that the problem that the push rod is connected by riveting points arranged at the near end of the embolization device in the prior art is solved, the protruding riveting points at the near end of the embolization device are eliminated, and the influence of the embolization device on the blood flow in the parent artery is reduced. It should also be understood that the proximal end of the embolization device may be of an ellipsoidal or cylindrical structure, and the proximal end face is formed by the closed ends of the mesh tubes arranged centripetally, and the pushing rod may pass through the central circular hole to connect with the fixing structure, so that the proximal end face is a nearly horizontal dense mesh surface, without recesses and protrusions, and uniform and dense, which may effectively cover the neck of the aneurysm, reduce the amount of blood flow into or out of the aneurysm, promote thrombosis, and further promote the healing of the aneurysm.

In addition to the advantages described above, the embolization device of the present invention is simpler to release, reduces the dependency on the embolization experience of a physician on a single aneurysm during a surgical procedure, and reduces the time required for the surgical procedure. In addition, the composite structure of the ellipsoidal structure and/or the cylindrical structure enables intratumoral molding to be more stable, the multilayer dense-net structure can improve embolization density, reduce the number of instruments required by an operation, improve the coverage of the neck of a tumor, increase the internal turbulence effect, promote the formation of thrombus in the tumor and accelerate embolization of the aneurysm. In addition, the embolization device is completely located within the aneurysm, avoiding the use of dual antiplatelet drugs. Moreover, in the unfolding state, the far end is of an ellipsoidal or cylindrical structure, and the farthest end can be contacted with the tumor top, so that the device can stably exist in the tumor without displacement, and the stability is good.

The above description is only for the preferred embodiment of the present invention, and not for any limitation of the scope of the present invention, and any modification and modification made by those skilled in the art according to the above disclosure all belong to the protection scope of the present invention.

Claims (12)

1. An embolism device is used for filling hemangioma, and is characterized by comprising a far-end grid body, a fixing structure and a near-end grid body which are sequentially connected in the axial direction, wherein the far-end grid body and the near-end grid body are both made of net pipes with two closed ends, and the far-end grid body and the near-end grid body can be twisted relatively; wherein: the embolic device has at least a compressed state and a deployed state and is switchable between the compressed state and the deployed state.

2. The embolization device of claim 1, wherein the distal mesh body and the proximal mesh body are configured to have a transverse dimension greater than a longitudinal dimension after deployment of the embolization device.

3. The embolization device of claim 2, wherein the distal mesh is an ellipsoid structure or a cylinder structure and the proximal mesh is an ellipsoid structure or a cylinder structure.

4. The embolic device of claim 1 or 2, wherein the proximal mesh body has a maximum outer diameter that is greater than or equal to a total longitudinal height of the embolic device after deployment.

5. The embolic device of claim 1 or 2, wherein a maximum outer diameter of the distal mesh body is less than or equal to a maximum outer diameter of the proximal mesh body after deployment of the embolic device.

6. The embolization device of claim 5, wherein the largest outer diameter of the distal mesh body is greater than or equal to 1/2 of the largest outer diameter of the proximal mesh body after deployment of the embolization device.

7. The embolization device of claim 5, wherein the proximal mesh body has a maximum outer diameter of 3mm to 25mm after deployment of the embolization device.

8. The embolization device of claim 7, wherein each of the mesh tubes is a woven body, the filament diameter of the woven filaments in the woven body is 0.0008-0.002 in, and the number of the woven filaments is 48-144.

9. The embolic device of claim 1 or 2, wherein the longitudinal height of the distal mesh body is 1/3-1/2 of the total longitudinal height of the embolic device after deployment.

10. The embolization device of claim 1 or 2, wherein the fixation structure is fixedly connected at one end to the mesh side of the proximal mesh body and at the other end to the mesh side of the distal mesh body.

11. The embolization device of claim 9, wherein the fixation structure is developable, and/or wherein the fixation structure is an elastic structure.

12. An embolic system comprising a push rod and the embolic device of any of claims 1-11, the distal end of the push rod being releasably connectable to the fixed structure of the embolic device.

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