CN217285928U

CN217285928U - Hemangioma plugging device, hemangioma plugging treatment device and hemangioma plugging system

Info

Publication number: CN217285928U
Application number: CN202220627730.4U
Authority: CN
Inventors: 陈冰; 郭爽; 常孟琪; 潘光亮; 郭远益
Original assignee: Microport Neurotech Shanghai Co Ltd
Current assignee: Microport Neurotech Shanghai Co Ltd
Priority date: 2022-03-21
Filing date: 2022-03-21
Publication date: 2022-08-26
Anticipated expiration: 2032-03-21

Abstract

The utility model relates to a hemangioma plugging device, a hemangioma plugging treatment device and a hemangioma plugging system; the hemangioma plugging system comprises a hemangioma plugging device and a micro-catheter; the hemangioma plugging device comprises a main body plugging structure in a net pipe shape, the main body plugging structure has a planar spiral expansion state and a compression state for delivering hemangioma from the blood vessel, and the outer diameter of the net pipe of the main body plugging structure is not uniform, so that the outer diameter of the planar spiral when the main body plugging structure is expanded is not uniformly distributed; the hemangioma plugging device is compressed in the micro-catheter and can be restored to an expanded state after being separated from the micro-catheter; hemangioma shutoff treatment device includes hemangioma plugging device and push rod, and the push rod is connected in main part block structure's near-end. The utility model is suitable for a fill anomalous aneurysm, the shaping is effectual, and realizes the shutoff to the tumor neck mouth more easily.

Description

Hemangioma plugging device, hemangioma plugging treatment device and hemangioma plugging system

Technical Field

The utility model relates to the technical field of medical equipment, in particular to hemangioma plugging device, hemangioma shutoff treatment device and hemangioma plugging system.

Background

Intracranial aneurysm is pathological protrusion of intracranial arterial wall, and the incidence rate is 5% -10%, and MRA research shows that the incidence rate of unbroken aneurysm of 35-75 years old adults 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 directly reach lesions, and the micro-trauma characteristic 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:

(1) the coil spring for embolization in the cavity of aneurysm is the main method for treating aneurysm at present, and the treatment principle is to promote thrombosis by changing local hemodynamic factors, so as to realize the occlusion and treatment of aneurysm. 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.

(2) The blood flow guiding device is taken as a major breakthrough of intracranial aneurysm intravascular treatment, and provides a brand-new method for complex aneurysm treatment. 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 a spring ring. 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 certain risk of delayed rupture after treatment of a portion of a large aneurysm.

(3) At present, some novel disposable embolization devices are usually prepared from shape memory materials and shaped into a sphere, a column or a disk, 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 sphere, 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 and is woven from a double layer of nitinol. The fourth embolism instrument is woven by double-layer memory alloy, is in a disc shape without limit, is in a tulip shape limited by a tumor wall when released in a 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 design of the first embolic device at the proximal anchor point orients the device in a symmetrical configuration for coverage of the neck of the aneurysm, primarily for treatment of bifurcated wide-diameter aneurysms, and particularly for regular aneurysms. In addition, the rivet point design of the first embolism instrument at the far end has an impact effect on the tumor wall, which easily causes the tumor wall to rupture and the aneurysm to bleed. And in some cases, the proximal rivet of the first embolic device may be extruded by the tumor wall and hernial into the parent artery, affecting the endothelialization process of the tumor neck. In addition, the first embolic device is typically 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 poor, and the device is easily displaced. 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 works in a substantially similar manner to the first embolic device and therefore suffers from the same problems. 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.

In addition to the above problems, the above-described structures are also once expanded and molded after extrusion, and are only applicable to regular spherical aneurysms, but not to irregular aneurysms such as prolate spherical aneurysms and oblate spherical aneurysms.

SUMMERY OF THE UTILITY MODEL

In order to solve at least one technical problem that exists among the prior art, the utility model aims to provide a hemangioma plugging device, hemangioma shutoff treatment device and hemangioma shutoff system for realize the shutoff treatment of hemangioma, and can be adapted to filling of anomalous aneurysm, the shaping is effectual.

In order to achieve the above object, according to one aspect of the present invention, there is provided a hemangioma occlusion device, comprising a main body occlusion structure in the shape of a mesh, wherein the main body occlusion structure has a planar spiral expanded state and a compressed state for delivering hemangioma from the inside of a blood vessel, and the outer diameter of the mesh of the main body occlusion structure is not uniform, so that the outer diameter of the planar spiral when the main body occlusion structure is expanded is not uniformly distributed.

Optionally, the aneurysm occlusion device further comprises a distal guide structure disposed outside the main body occlusion structure, a proximal end of the distal guide structure being connected to a distal end of the main body occlusion structure, the distal guide structure having a helical expanded state and a compressed state for delivery from within the blood vessel to the aneurysm; the spiral direction of the far-end guide structure is the same as the spiral direction of the main body plugging structure.

Optionally, the ratio of the minimum mesh tube diameter to the maximum mesh tube diameter of the main body plugging structure is not less than 1: 2, the ratio of the maximum outer diameter to the minimum outer diameter of the plane spiral when the main body plugging structure is unfolded is 1.5-1.8.

Optionally, the helical outer diameter of the distal guide structure is uniformly or non-uniformly distributed when deployed.

Optionally, the maximum planar height of the hemangio-occlusion device when deployed is no less than 1/4 of the maximum outer diameter of the planar spiral when the main body occlusion structure is deployed.

Optionally, the maximum plane height of the hemangioma occlusion device when being unfolded is 1/3-2/3 of the maximum outer diameter of the plane spiral when the main body occlusion structure is unfolded.

Optionally, the maximum outer diameter of the helix when the distal guiding structure is deployed is no greater than 1/2 of the maximum outer diameter of the planar helix when the main body occluding structure is deployed.

Optionally, the distal guiding structure and the main plugging structure are made of the same mesh tube by pre-shaping.

Optionally, the main body occlusion structure has at least one planar spiral when deployed, the planar spiral is formed by winding a mesh tube spiral, and the mesh tube has cross sections of different shapes and/or sizes when deployed.

Optionally, the mesh tube is woven by weaving filaments, the filament diameter of the weaving filaments is 0.0008-0.002 in, the number of the weaving filaments is 48-144, and the maximum outer diameter of the mesh tube is 2-8 mm.

Optionally, the maximum outer diameter of the planar spiral when the main body occlusion structure is unfolded is 4mm to 32 mm.

Optionally, the proximal end of the hemangioma occlusion device is captively fixed by the proximal visualization marker, and/or the distal end of the hemangioma occlusion device is captively fixed by the distal visualization marker.

In order to achieve the above objective, according to the present invention, the present invention further provides a hemangioma plugging treatment device, including any one of hemangioma plugging device and push rod, push rod detachable connect in hemangioma plugging device's main body plugging structure's near-end.

Optionally, the push rod extends in a tangential direction of a spiral line of the planar spiral when the main body occlusion structure is deployed.

To achieve the above object, according to another aspect of the present invention, there is provided a hemangioma occlusion system comprising the hemangioma occlusion device of any one of the above aspects and a microcatheter, wherein the hemangioma occlusion device is compressed in the microcatheter and can be restored to a deployed state after being detached from the microcatheter.

Compared with the prior art, the utility model provides a hemangioma plugging device, hemangioma shutoff treatment device and hemangioma plugging system have following advantage:

the hemangioma occlusion device comprises a main body occlusion structure in a net pipe shape, wherein the main body occlusion structure has a planar spiral expanded state and a compressed state for delivering from the inside of a blood vessel to hemangioma, and the outer diameter of the net pipe of the main body occlusion structure is uneven, so that the outer diameter distribution of the planar spiral is uneven when the main body occlusion structure is expanded; due to the configuration, the hemangioma plugging device can form a continuous dense-network covering surface at the neck of the aneurysm through the side wall of the main body plugging structure, so that the neck of the aneurysm can be covered well, more forms and positions of the aneurysm can be adapted, especially the uneven outer diameter of the main body plugging structure can improve the compliance of the hemangioma plugging device to the cavity of the irregular aneurysm, the forming effect is improved, the hemangioma plugging device is particularly suitable for plugging the irregular aneurysm such as a long sphere or a flat sphere, and the treatment range of the hemangioma plugging device is improved; the planar spiral structure of the main body plugging structure when being unfolded can improve the space division in the aneurysm cavity, promote the turbulence effect and the formation of thrombus, promote the formation of thrombus in the aneurysm and accelerate the embolization of the aneurysm;

secondly, the hemangioma plugging device preferably guides the plugging process of the main body plugging structure through a far-end guide structure, so that the whole hemangioma plugging device is not expanded and formed at one time when the microcatheter is pushed out, the plugging is more stable, and the rotation and the forming are easier;

thirdly, the hemangioma plugging device is spirally plugged, so that the far end is riveted in the aneurysm cavity and is not directly contacted with the aneurysm wall, and the influence of the hemangioma plugging device on the aneurysm wall is reduced; meanwhile, the near-end riveting point is parallel to the tumor wall, and can be pressed between the main body blocking structure and the tumor wall, so that the covering of the tumor neck is not influenced, and the stability is good.

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 schematic top view of a preferred embodiment of a hemangioma occlusion device, wherein the distal guide structure has 1 elliptical spiral when deployed and the main occlusion structure has 1 substantially elliptical spiral when deployed;

fig. 2a is a schematic top view of a aneurysm occlusion device according to a second preferred embodiment of the present invention, wherein the distal guiding structure has 1.5 turns of a circular helix when deployed and the main body occlusion structure has 1.5 turns of a generally elliptical helix when deployed;

FIG. 2b is a schematic front view of the aneurysm occlusion device of FIG. 2 a;

fig. 3 is a diagram illustrating a state that the aneurysm occlusion device according to the second preferred embodiment of the present invention is completely released inside the aneurysm;

fig. 4 is a schematic top view of a third preferred embodiment of the hemangioma occlusion device of the present invention, wherein the distal guiding structure has 2 turns of a generally elliptical spiral when deployed and the main occlusion structure has 2 turns of a generally elliptical spiral when deployed.

In the figure: 10. 20, 30-hemangioma occlusion device; 40-aneurysm; 41-neck and neck; 50-parent artery; 11. 21, 31-a body occlusion structure; 12. 22, 32-distal guide structure; a-a proximal end of a hemangioma occlusion device; b-the distal end of the hemangioma occlusion device; a-the maximum outer diameter of the planar spiral; b-minimum outer diameter of the planar spiral; d-the maximum outer diameter of the distal guide structure; d-the maximum diameter of the mesh tube in the main body plugging structure.

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, the term "proximal" generally refers to the end near the operator of the device, and "distal" generally refers to the end of the device that enters the body first, unless the context clearly dictates otherwise.

The core idea of the utility model is to provide a hemangioma plugging device, which comprises a main body plugging structure in a net pipe shape; the main body occlusion structure has an expanded state and a compressed state; when the whole hemangioma plugging device is conveyed in the microcatheter, the main body plugging structure has a compressed state, at the moment, the radial dimension of the main body plugging structure is compressed, the axial direction is elongated, and the outer diameter of the whole hemangioma plugging device is smaller, so that the microcatheter is convenient to deliver the hemangioma plugging device through a narrow blood vessel; and after the whole hemangioma plugging device is pushed out of the microcatheter, the main body plugging structure is restored to the unfolding state, at the moment, the main body plugging structure is automatically restored to the planar spiral shape, and the outer diameter of the planar spiral is not uniformly distributed, namely, the outer diameter of the planar spiral is not consistent, so that the main body plugging structure is adaptive to the aneurysms with irregular shapes. It can be understood that the uneven plane spiral of the main body occlusion structure when being unfolded is mainly caused by the uneven diameter of the cross section of the mesh tube, and the uneven cross section of the mesh tube can improve the compliance of the hemangioma occlusion device to the irregular aneurysm cavity and improve the forming effect. Therefore, the outer diameter of the mesh tube of the main body plugging structure is not uniform, so that the outer diameter distribution of the planar spiral when the main body plugging structure is unfolded is not uniform. It is to be understood that "irregular" generally refers to shapes that are not regularly followed, and that, in general, irregularly shaped aneurysms refer primarily to non-spherical aneurysms, such as prolate or oblate spheroidal aneurysms or other non-spherical aneurysms. By prolate spheroid or oblate spheroid is meant a geometric shape of non-constant diameter, such as an elliptical or elliptical-like structure resembling a fusiform, olivine, etc., whereas a prolate spheroid has a greater ratio of its largest outer diameter (e.g., the major axis of the ellipse) to its smallest outer diameter (e.g., the minor axis of the ellipse) relative to an oblate spheroid, making the geometric shape more prone to a flattened shape. It should be understood, however, that the aneurysm occlusion device of the present invention is not limited to aneurysms, but may be hemangiomas occurring in other blood vessels.

The present invention will be described in more detail 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.

< example one >

Referring to fig. 1, a preferred embodiment of the present invention provides a hemangioma occlusion device 10 for performing an occlusion treatment of a hemangioma, particularly an intracranial aneurysm, and in particular, the hemangioma occlusion device 10 is suitable for occlusion treatment of an irregular shaped aneurysm.

The hemangioma plugging device 10 comprises a main body plugging structure 11 in a net tube shape, and preferably, the hemangioma plugging device 10 further comprises a far-end guide structure 12 arranged outside the main body plugging structure 11. The main body occluding structure 11 is a mesh-like lattice body having a planar helical expanded state and a compressed state for delivery from within a blood vessel to an aneurysm. Specifically, when the body blocking structure 11 is in a compressed state within the microcatheter, the push out microcatheter will self-return to the deployed state. Moreover, the outer diameters of the mesh tubes of the main body occlusion structure 11 are not uniform (i.e., the outer diameters of the mesh tubes are not equal), so that the outer diameters of the planar spirals are not uniformly distributed when the main body occlusion structure 11 is deployed, i.e., the planar spirals of the main body occlusion structure 11 have different outer diameters when deployed, so that the aneurysm occlusion device 10 is suitable for irregular aneurysm forms. Here, it should be understood that the shape of the planar spiral of the subject occluding structure 11 when deployed is non-circular, and the outer diameter of the planar spiral when deployed refers to the outer diameter of the outermost spiral. In this context, the first helix starts from the most distal end of the body blocking structure 11, and the last helix is the outermost helix.

In this embodiment, the planar spiral shape of the main body occlusion structure 11 during deployment is an ellipse or an ellipse-like shape, so as to be suitable for an oblate aneurysm shape, and overcome the defect that various hemangioma occlusion structures in the prior art are only suitable for regular spherical aneurysms. And because the outer side of the main body plugging structure 11 is a mesh pipe surface with uniform and continuous meshes, the outer side of the whole main body plugging structure 11 can be used for covering the aneurysm neck, so that the hemangioma plugging device 10 has certain isotropy, is suitable for aneurysm packing of a bifurcation part and a side wall part, and has a wider treatment range. In addition, the proximal end a of the whole hemangioma plugging device 10 is the proximal end a of the main body plugging structure 11, and the proximal end a can be pressed and held between the main body plugging structure 11 and the tumor wall, so that the proximal end a is parallel to the tumor wall, the tumor neck can be continuously covered while the influence on the tumor wall is reduced, and the metal coverage rate of the tumor neck opening is high.

The number of spirals of the main plugging structure 11 during deployment at least comprises one planar spiral, preferably the number of spirals of the main plugging structure 11 during deployment is between 2 and 4. However, in practice, the number of spirals of the main body occlusion structure 11 during the deployment can be set according to the size of the aneurysm, for example, the spiral with a small number of planar spirals is suitable for the treatment of small aneurysms, and the planar spiral with an increased number of turns can treat larger aneurysms.

In a specific example, as shown in fig. 1, the main body occluding structure 11 has 1 turn of a planar spiral when deployed, the 1 turn of the planar spiral being generally elliptical, and therefore, the outer diameter of the planar spiral when deployed is not uniformly distributed. In more detail, the planar spiral of the main body occlusion structure 11 when deployed has a maximum outer diameter A, which can be understood as the length of the major axis of the ellipse, and a minimum outer diameter B, which can be understood as the length of the minor axis of the ellipse, the direction of the major axis being parallel to the plane of the tumor neck. In the present embodiment, the outer diameter of the planar spiral refers to the outer diameter of the outermost one of the planar spirals projected in a projection plane perpendicular to the axis of the planar spiral.

In this embodiment, the main body plugging structure 11 is formed by spirally winding a mesh tube, and the mesh tube is preferably formed by weaving braided wires. The material of the braided wire preferably 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 (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 grid body has the functions of memorizing and recovering the original shape. Preferably, the main body blocking structure 11 is woven by using a developable weaving yarn, or the main body blocking structure 11 is formed by mixing and weaving a developable weaving yarn and a non-developable weaving yarn. By the design, the main body plugging structure 11 can be developed under X-rays, the elasticity of the main body plugging structure 11 is ensured, and the main body plugging structure 11 has strong recovery capability and capability of keeping the original shape. The developing material of the developable braided wire is not particularly limited, and for example, the developing material includes, but is not limited to, one of or an alloy of radiopaque materials such as platinum (Pt), iridium (Ir), gold (Au), silver, tantalum, and tungsten.

In one example, the mesh tube can be formed by co-weaving memory alloy wires (such as Ni-Ti and the like) and metal wires with good developability. In another example, the mesh tube may also be woven from composite filaments (DFT) of memory alloy material and developer material. The composite wire DFT comprises a sleeve and a core wire, wherein the sleeve is coated outside the core wire, the sleeve is made of a memory alloy material, and the core wire is made of a developing material.

Further, the diameter of the braided wire can be 0.0008-0.002 in, the number of the braided wires can be 48-144, and the maximum diameter d of the mesh tube can be 2-8 mm. Alternatively, the maximum outer diameter A of the planar spiral when the body blocking structure 11 is deployed may be between 4mm and 32 mm.

With continued reference to fig. 1, when the outer diameter distribution of the planar spiral of the main body occluding structure 11 is not uniform during deployment, the cross-sectional shapes and/or sizes of the mesh tubes are not the same, so that the cross-section of the mesh tubes is not uniform throughout the extension path of the planar spiral, e.g., a combination of circular and elliptical shapes, and the different cross-sections constitute a planar spiral structure with non-uniform overall outer diameter.

Further, the ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spiral of the main body occlusion structure 11 when deployed is not too small, and if not too small, it is not effective for packing irregular aneurysms. Preferably, the ratio of the minimum mesh tube diameter to the maximum mesh tube diameter of the main body plugging structure 11 is not less than 1: 2, so that the ratio of the maximum outer diameter A to the minimum outer diameter B of the planar spiral of the main body plugging structure 11 when being unfolded is 1.5-1.8. As in the example of fig. 1, the ratio between the maximum outer diameter a and the minimum outer diameter B of the planar spiral of the main body occluding structure 11 when deployed is 1.5.

As mentioned above, the aneurysm occlusion device 10 preferably further comprises a distal guiding structure 12, wherein a proximal end of the distal guiding structure 12 is connected to a distal end of the main body occlusion structure 11, i.e. the distal guiding structure 12 is disposed entirely outside the main body occlusion structure 11 and located at a distal end of the main body occlusion structure 11. Likewise, the distal guide structure 12 has a helical expanded state and a compressed state for delivery from within the vessel to the aneurysm. When the distal guide structure 12 is in a compressed state while inside the microcatheter, the pushout microcatheter will self-return to the deployed state. The helix of the distal guide structure 12 when deployed may be a planar helix (i.e., a two-dimensional helix) or a three-dimensional helix. The spiral direction of the distal guiding structure 12 and the spiral direction of the main body plugging structure 11 may be the same or different, and preferably, the spiral direction of the distal guiding structure 12 and the spiral direction of the main body plugging structure 11 are the same.

The distal guide structure 12 may have a helical configuration with a uniform or non-uniform distribution of outer diameter when deployed, such as 1-turn regular elliptical helix in fig. 1. The number of spirals of the distal guide structure 12 during deployment is also set by the size of the aneurysm and is therefore not limited to 1 spiral. For small aneurysms, a smaller number of helical turns of the distal guide structure 12 may be used, while for larger sizes, a larger number of helical turns of the distal guide structure 12 may be used.

The distal end guide structure 12 is generally a slender linear structure when compressed in the microcatheter, and the outer diameter of the spiral body is far smaller than that of the mesh tube of the main body plugging structure 11. On one hand, the distal guiding structure 12 plays a guiding role in the initial stage of release of the main body occlusion structure 11, that is, the spiral structure of the distal guiding structure 12 can guide the main body occlusion structure 11 to rotate in the aneurysm cavity and sequentially cover along the inner wall of the aneurysm until the main body occlusion structure 11 is completely released; on the other hand, after the main body occlusion structure 11 is released, the distal guiding structure 12 internally supports the main body occlusion structure 11 to a certain extent, so that the overall stability of the whole hemangioma occlusion device is increased when a large aneurysm is filled, and the hemangioma occlusion device is not easily compressed and displaced. And because the external diameter of the spiral body of the far-end guide structure 12 is small, the far-end guide structure 12 is relatively flexible on the whole, and the impact influence of the whole hemangioma plugging device on the tumor wall can be reduced. In addition, the profile shape of the helical structure of the distal guiding structure 12 in the deployed state may be other regular or irregular helical structures besides the regular elliptical helical structure shown in fig. 1, and this is not particularly limited.

The distal end guide structure 12 can be integrally formed with the main body plugging structure 11, for example, the distal end guide structure can be formed by rotationally winding, compressing and shaping the same net pipe, so that one net pipe is integrally formed into a structure with a long and thin distal end, an enlarged middle part and a compressed proximal end. Of course, in other embodiments, the distal guiding structure 12 may also be manufactured and formed separately from the main body occlusion structure 11, that is, after the two are manufactured separately, the distal guiding structure 12 is fixed at the distal end of the main body occlusion structure 11. Compared with the split molding, the integral molding process is simpler, and additional connection processing is not required to be performed at the far end of the main body plugging structure 11 and the near end of the far end guide structure 12.

Further, the maximum planar height of the hemangioma occluding device 10 when deployed is not less than 1/4 of the maximum outer diameter a of the planar spiral of the body occluding structure 11 when deployed, more preferably the maximum planar height is 1/3-2/3 of the maximum outer diameter a of the planar spiral of the body occluding structure 11 when deployed. As a specific example, the maximum planar height of the aneurysm occlusion device 10 when deployed is 0.5 times the maximum outer diameter a of the planar spiral of the body occlusion structure 11 when deployed. It should be understood that the maximum planar height of the hemangio-occlusion device 10 when deployed refers to the maximum height of the entire hemangio-occlusion device in a direction perpendicular to the plane of the planar spiral, which is perpendicular to the plane of the neck of the tumor.

The distal guide structure 12 has at least one helix and the outer diameter of the first helix from its distal end is the same as the inner diameter of the subsequent helix so that the subsequent helix can wrap around the previous helix. Further, the maximum outer diameter D of the helix of the distal guide structure 12 when deployed is no greater than 1/2 of the maximum outer diameter A of the planar helix of the body blocking structure 12 when deployed. As in this embodiment, the maximum outer diameter D of the helix of the distal guide structure 12 when deployed is 1/2 the maximum outer diameter A of the planar helix of the body blocking structure 11 when deployed.

With continued reference to fig. 1, the proximal end a of the main body occlusion structure 11 is preferably bound and fixed by the proximal visualization mark, and the proximal ends of the braided filaments are bound and fixed together to form a non-invasive proximal end a, so as to avoid affecting the tumor wall. Preferably, the distal end b of the distal guide structure 12 (i.e., the distal end of the entire device) is constrained by the distal visualization marker, which constrains the distal braided wire ends together to form an atraumatic distal end b. The proximal visualization marker and the distal visualization marker may be visualization cannulas.

In a specific embodiment, as shown in FIG. 1, the main body occluding structure 11 has 1 generally elliptical planar spiral when deployed, the distal guiding structure 12 has 1 generally elliptical spiral when deployed, and the ratio between the maximum outer diameter a and the minimum outer diameter B of the planar spiral of the main body occluding structure 11 when deployed is 1.5, the maximum planar height of the hemangioma occlusion device 10 when deployed is 0.5 times the maximum outer diameter a of the planar spiral of the main body occlusion structure 11 when deployed, the maximum outer diameter D of the helix of the distal guide structure 12 when deployed is 1/2 of the maximum outer diameter a of the planar helix of the body occluding structure 11 when deployed, the hemangioma occlusion device 10 can be applied to the occlusion of oblate irregular aneurysms, and the long axis direction (i.e. the direction of the maximum outer diameter) of the main body occlusion structure 11 is parallel to the plane of the neck of the aneurysm.

< example two >

Referring to fig. 2a and 2b, a second preferred embodiment of the present invention provides a hemangioma occlusion device 20, also for performing an occlusion treatment of hemangiomas, in particular intracranial aneurysms, in particular, the hemangioma occlusion device 20 is suitable for occlusion treatment of irregularly shaped aneurysms.

The hemangioma plugging device 20 comprises a main body plugging structure 21 in a net tube shape, and preferably, the hemangioma plugging device 20 further comprises a far-end guide structure 22 arranged outside the main body plugging structure 21. The main body occluding structure 11 is a mesh-like lattice having a planar helical expanded state and a compressed state for delivery from within a blood vessel to an aneurysm. Specifically, when the main body occlusion structure 21 is in a compressed state within the microcatheter, the expelled microcatheter will self-return to the deployed state. Moreover, the outer diameters of the mesh tubes of the main body occlusion structure 21 are not uniform (i.e., the outer diameters of the mesh tubes are not equal), so that the outer diameters of the planar spirals of the main body occlusion structure 21 when deployed are not uniformly distributed, i.e., the planar spirals of the main body occlusion structure 21 when deployed have different outer diameters, so that the aneurysm occlusion device 20 is suitable for irregular aneurysm shapes. Here, it should be understood that the shape of the planar spiral of the main body occlusion structure 21 when deployed is non-circular, and the outer diameter of the planar spiral when deployed refers to the outer diameter of the outermost spiral. In this context, the first helix starts from the distal-most end of the body occluding structure 21 and the last helix is the outermost helix.

In this embodiment, the planar spiral shape of the main body occlusion structure 21 during deployment is an ellipse or an ellipse-like shape, which is suitable for an oblate aneurysm shape, and overcomes the defect that various hemangioma occlusion structures in the prior art are only suitable for regular spherical aneurysms. And because the lateral surface of main part plugging structure 21 is the even and continuous net management face of mesh for the lateral surface of whole main part plugging structure 21 all can be used to the cover of tumor neck, makes hemangioma plugging device 20 have certain each sex, is applicable to the aneurysm of crotch portion and lateral wall portion simultaneously and packs, and the treatment scope is wider. In addition, the proximal end a of the whole hemangioma occlusion device 20 is the proximal end a of the main body occlusion structure 21, and the proximal end a can be pressed and held between the main body occlusion structure 21 and the tumor wall, so that the proximal end a is parallel to the tumor wall, the tumor neck can be continuously covered while the influence on the tumor wall is reduced, and the metal coverage rate of the tumor neck opening is high.

The number of spirals of the main plugging structure 21 during deployment at least comprises one planar spiral, preferably the number of spirals of the main plugging structure 21 during deployment is 2 to 4. However, in practice, the number of spirals of the main body occlusion structure 21 during the deployment can be set according to the size of the aneurysm, for example, the spiral with a small number of turns in a plane is suitable for the treatment of small-sized aneurysms, and the spiral with a larger number of turns in a plane can be treated.

In a specific example, as shown in fig. 2a, the main body occluding structure 21 has 1.5 turns of a planar spiral when deployed, the 1.5 turns of the planar spiral being substantially elliptical, and therefore, the outer diameter of the planar spiral when deployed is not uniformly distributed. In more detail, the planar spiral of the main body occlusion structure 21 when deployed has a maximum outer diameter a and a minimum outer diameter B, the maximum outer diameter a can be understood as the length of the major axis of the ellipse, and the minimum outer diameter B can be understood as the length of the minor axis of the ellipse, and the direction of the major axis is parallel to the plane of the tumor neck. In the present embodiment, the outer diameter of the planar spiral refers to the outer diameter of the outermost one of the planar spirals projected in a projection plane perpendicular to the axis of the planar spiral.

In this embodiment, the main body plugging structure 21 is formed by spirally winding a mesh tube, and the mesh tube is preferably formed by weaving braided wires. The material of the braided wire preferably 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 (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 grid body has the functions of memorizing and recovering the original shape. Preferably, the main body blocking structure 21 is woven by using a developable weaving wire, or the main body blocking structure 21 is formed by co-weaving a developable weaving wire and a non-developable weaving wire. By the design, the main body plugging structure 21 can be developed under X-rays, the elasticity of the main body plugging structure 21 is ensured, and the main body plugging structure 21 has strong recovery capability and the capability of keeping the original shape. The developing material of the developable braided wire is not particularly limited, and for example, the developing material includes, but is not limited to, one of or an alloy of radiopaque materials such as platinum (Pt), iridium (Ir), gold (Au), silver, tantalum, and tungsten.

Further, the diameter of the braided wire can be 0.0008-0.002 in, the number of the braided wires can be 48-144, and the maximum diameter d of the mesh tube can be 2-8 mm. Alternatively, the maximum outer diameter A of the planar spiral of the main body occluding structure 11 when deployed may be 4mm to 32 mm.

With continued reference to fig. 2, when the outer diameter distribution of the planar spiral of the main body occluding structure 21 is not uniform during deployment, the cross-sectional shapes and/or sizes of the mesh tubes are not the same, so that the cross-section of the mesh tubes is not uniform throughout the extension path of the planar spiral, e.g., a combination of circular and elliptical shapes, and the different cross-sections constitute a planar spiral structure with non-uniform overall outer diameter.

Further, the ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spiral of the main body occlusion structure 21 when deployed is not too small, and if not too small, it is not effective in packing irregular aneurysms. Preferably, the ratio of the minimum mesh tube diameter to the maximum mesh tube diameter of the main body plugging structure 21 is not less than 1: 2, so that the ratio of the maximum outer diameter A to the minimum outer diameter B of the planar spiral of the main body plugging structure 21 when being unfolded is 1.5-1.8. As in the example of fig. 2a and 2B, the ratio between the maximum outer diameter a and the minimum outer diameter B of the planar spiral of the body occluding structure 21 when deployed is 1.6.

As mentioned above, the aneurysm occlusion device 20 preferably further comprises a distal guiding structure 22, wherein a proximal end of the distal guiding structure 22 is connected to a distal end of the main body occlusion structure 21, i.e. the distal guiding structure 22 is disposed entirely outside the main body occlusion structure 21 and located at a distal end of the main body occlusion structure 21. Likewise, the distal guide structure 22 has a helical expanded state and a compressed state for delivery from within the vessel to the aneurysm. When the distal guide structure 22 is in a compressed state while inside the microcatheter, the pushout microcatheter will self-return to the deployed state. The helix of the distal guide structure 22 when deployed may be a planar helix (i.e., a two-dimensional helix) or a three-dimensional helix. The spiral direction of the distal guiding structure 22 and the spiral direction of the main body blocking structure 21 may be the same or different, and preferably, the spiral direction of the distal guiding structure 22 and the spiral direction of the main body blocking structure 21 are the same.

The distal guide structure 22 may have a helical configuration with a uniform or non-uniform distribution of outer diameter when deployed, such as 1.5 regular circular helix in fig. 2 a. The number of spirals of the distal guide structure 22 during deployment is also set based on the size of the aneurysm and is therefore not limited to 1.5 spirals. For small aneurysms, a smaller number of helical turns of the distal guide structure 22 may be used, while for larger sizes, a larger number of helical turns of the distal guide structure 22 may be used.

The distal guiding structure 22 is generally a slender linear structure when compressed in the microcatheter, and the outer diameter of the spiral body is far smaller than that of the mesh tube of the main body plugging structure 21. On one hand, the distal guiding structure 22 plays a guiding role at the initial stage of release of the main body occlusion structure 21, that is, the spiral structure of the distal guiding structure 22 can guide the main body occlusion structure 21 to rotate in the aneurysm cavity and sequentially cover along the inner wall of the aneurysm until the main body occlusion structure 21 is completely released; on the other hand, after the main body occlusion structure 21 is released, the distal guiding structure 22 internally supports the main body occlusion structure 21 to a certain extent, so that the overall stability of the whole hemangioma occlusion device is increased when a large aneurysm is filled, and the hemangioma occlusion device is not easily compressed and displaced. Moreover, because the outer diameter of the spiral body of the far-end guide structure 22 is small, the far-end guide structure 12 is relatively flexible as a whole, and the impact influence of the whole hemangioma plugging device on the tumor wall can be reduced. In addition, the profile shape of the helical structure of the distal guiding structure 22 in the expanded state may be other regular or irregular helical structures besides the regular circular helical structure shown in fig. 2a, and this is not particularly limited.

The distal end guide structure 22 can be integrally formed with the main body plugging structure 21, for example, the distal end guide structure can be formed by rotationally winding, compressing and shaping the same net pipe, so that one net pipe is integrally formed into a structure with a long and thin distal end, an enlarged middle part and a compressed proximal end. Of course, in other embodiments, the distal guiding structure 22 may also be manufactured and formed separately from the main body blocking structure 21, that is, after the two are manufactured separately, the distal guiding structure 22 is fixed at the distal end of the main body blocking structure 21. Compared with the split molding, the integral molding process is simpler, and additional connection processing is not required to be performed at the far end of the main body blocking structure 21 and the near end of the far end guide structure 22.

Further, the maximum plane height of the hemangioma occlusion device 20 when deployed is not less than 1/4 of the maximum outer diameter A of the planar spiral of the main body occlusion structure 21 when deployed, more preferably the maximum plane height is 1/3-2/3 of the maximum outer diameter A of the planar spiral of the main body occlusion structure 21 when deployed. As a specific example, the maximum planar height of the aneurysm occlusion device 20 when deployed is 2/3 of the maximum outer diameter a of the planar spiral of the main body occlusion structure 21 when deployed. It should be understood that the maximum planar height of the hemangioma occlusion device 20 when deployed refers to the maximum height of the entire hemangioma occlusion device in a plane perpendicular to the plane of the planar spiral, which is perpendicular to the plane of the tumor neck.

The distal guide structure 22 has at least one helix, and the outer diameter of the first helix from its distal end is the same as the inner diameter of the subsequent helix, so that the subsequent helix can wrap around the previous helix. Further, the maximum outer diameter D of the helix of the distal guide structure 22 when deployed is no greater than 1/2 of the maximum outer diameter A of the planar helix of the body blocking structure 22 when deployed. As in this embodiment, the maximum outer diameter D of the helix of the distal guide structure 22 when deployed is 4/5 the maximum outer diameter A of the planar helix of the body blockage structure 21 when deployed.

With continued reference to fig. 2, the proximal end a of the main body occlusion structure 21 is preferably bound and fixed by the proximal visualization mark, and the proximal ends of the braided filaments are bound and fixed together to form a non-invasive proximal end a, so as to avoid affecting the tumor wall. Preferably, the distal end b of the distal guide structure 22 (i.e., the distal end of the entire device) is held captive by the distal visualization marker, holding the distal ends of the braided filaments together to form a non-invasive distal end b. The proximal visualization marker and the distal visualization marker may be visualization cannulas.

In one specific embodiment, as shown in FIG. 2a, the main body occluding structure 21 has 1.5 turns of a generally elliptical planar spiral when deployed, the distal guiding structure 22 has 1.5 turns of a generally circular spiral when deployed, and the ratio between the maximum outer diameter a and the minimum outer diameter B of the planar spiral of the main body occluding structure 21 when deployed is 1.6, the maximum planar height of the hemangioma occluding device 20 when deployed is 2/3 of the maximum outer diameter a of the planar spiral of the main body occluding structure 21 when deployed, the maximum outer diameter D of the helix of the distal guide structure 22 when deployed is 4/5 the maximum outer diameter a of the planar helix of the body occluding structure 21 when deployed, the aneurysm occlusion device 20 can be adapted to occlude an oblate wide-necked aneurysm, with the major axis direction (i.e., the direction of the maximum outer diameter) of the main body occlusion structure 21 being parallel to the plane of the neck of the aneurysm.

Referring to fig. 3, when the aneurysm occlusion device 20 is completely released and then is packed in the oblate aneurysm 40, the outer side surface of the main body occlusion structure 21 is a mesh tube surface with uniform and continuous meshes and covers the neck opening 41, and the proximal end a of the whole aneurysm occlusion device is compressed between the aneurysm wall and the outer side surface of the mesh tube, so that the proximal end development mark is parallel to the tangential direction of the aneurysm wall, the influence on the aneurysm wall can be reduced, the continuous coverage of the aneurysm neck can not be affected, and the aneurysm-carrying artery 50 can not be protruded. Wherein the distal guiding structure 22 guides the main body occlusion structure 21 to rotate in the aneurysm cavity and to sequentially cover along the inner wall of the aneurysm 40 until the main body occlusion structure 21 is completely released.

< example three >

Referring to fig. 4, a third preferred embodiment of the present invention provides a hemangioma occlusion device 30, also for use in effecting occlusion treatment of hemangiomas, particularly intracranial aneurysms, and in particular, the hemangioma occlusion device 30 is suitable for occlusion treatment of irregularly shaped aneurysms.

The hemangioma occlusion device 30 comprises a main body occlusion structure 31 in a net tube shape, and preferably, the hemangioma occlusion device 30 further comprises a distal guiding structure 32 arranged outside the main body occlusion structure 31. The main body occlusion structure 31 is a mesh tubular mesh body and has a planar helical expanded state and a compressed state for delivery from within a blood vessel to an aneurysm. Specifically, when the body blocking structure 31 is in a compressed state within the microcatheter, the push out microcatheter will self-return to the deployed state. Moreover, the outer diameters of the mesh tubes of the main body occlusion structure 31 are not uniform (i.e., the outer diameters of the mesh tubes are not equal), so that the outer diameters of the planar spirals are not uniformly distributed when the main body occlusion structure 31 is deployed, i.e., the planar spirals of the main body occlusion structure 31 have different outer diameters when deployed, so that the aneurysm occlusion device 30 is suitable for irregular aneurysm shapes. Here, it should be understood that the shape of the planar spiral of the main body occluding structure 31 when deployed is non-circular, and the outer diameter of the planar spiral when deployed refers to the outer diameter of the outermost spiral. In this context, the first helix starts from the distal-most end of the body blocking structure 31, and the last helix is the outermost helix.

In this embodiment, the planar spiral shape of the main body occlusion structure 31 during deployment is an ellipse or an ellipse-like shape, so as to be suitable for a long spherical aneurysm shape, and overcome the defect that various hemangioma occlusion structures in the prior art are only suitable for regular spherical aneurysms. And because the outer side surface of the main body plugging structure 31 is a mesh pipe surface with uniform and continuous meshes, the outer side surface of the whole main body plugging structure 31 can be used for covering the aneurysm neck, so that the hemangioma plugging device 30 has certain isotropy, is suitable for aneurysm filling of a bifurcation part and a side wall part, and has wider treatment range. In addition, the proximal end a of the whole hemangioma occlusion device 30 is the proximal end a of the main body occlusion structure 31, and the proximal end a can be pressed and held between the main body occlusion structure 31 and the tumor wall, so that the proximal end a is parallel to the tumor wall, the tumor neck can be continuously covered while the influence on the tumor wall is reduced, and the metal coverage rate of the tumor neck opening is high.

The number of spirals of the main plugging structure 31 during deployment at least comprises one planar spiral, preferably the number of spirals of the main plugging structure 31 during deployment is 2 to 4. However, in practice, the number of spirals of the main body occlusion structure 31 when being deployed may be set according to the size of the aneurysm, for example, when the number of turns of the planar spiral is small, the spiral is suitable for treating small-sized aneurysms, and when the number of turns of the planar spiral is increased, the aneurysm with larger size can be treated.

In a specific example, as shown in fig. 4, the main body occlusion structure 31 has 2 turns of a planar spiral when deployed, the 2 turns of the planar spiral being substantially elliptical, and therefore, the outer diameter of the planar spiral when deployed is not uniformly distributed. In more detail, the planar spiral of the main body occlusion structure 31 when deployed has a maximum outer diameter a and a minimum outer diameter B, the maximum outer diameter a can be understood as the length of the major axis of the ellipse, and the minimum outer diameter B can be understood as the length of the minor axis of the ellipse, and the direction of the major axis is perpendicular to the plane of the tumor neck. In the present embodiment, the outer diameter of the planar spiral refers to the outer diameter of the outermost one of the planar spirals as projected in a projection plane perpendicular to the axis of the planar spiral.

In this embodiment, the main body plugging structure 311 is formed by winding a mesh tube in a preset spiral manner, and the mesh tube is preferably formed by weaving braided wires. The material of the braided wire preferably 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 (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 grid body has the functions of memorizing and recovering the original shape. Preferably, the main body blocking structure 31 is woven by using a developable weaving yarn, or the main body blocking structure 31 is formed by mixing and weaving a developable weaving yarn and a non-developable weaving yarn. By adopting the design, the main body plugging structure 31 can be developed under X-ray, the elasticity of the main body plugging structure 31 is ensured, and the main body plugging structure 31 has stronger recovery capability and keeps the original shape. The developing material of the developable braided wire is not particularly limited, and for example, the developing material includes, but is not limited to, one of or an alloy of radiopaque materials such as platinum (Pt), iridium (Ir), gold (Au), silver, tantalum, and tungsten.

Further, the diameter of the braided wire can be 0.0008-0.002 in, the number of the braided wires can be 48-144, and the maximum diameter d of the mesh tube can be 2-8 mm. Alternatively, the maximum outer diameter a of the planar spiral of the main body occluding structure 31 when deployed may be 4mm to 32 mm.

With continued reference to fig. 4, when the outer diameter distribution of the planar spiral of the main body occlusion structure 31 is not uniform during the deployment, the cross-sectional shapes and/or sizes of the mesh tubes are not substantially the same, so that the cross-section of the mesh tubes is not uniform in the extending path of the entire planar spiral, such as a combination of circular and elliptical shapes, and the different cross-sections constitute the planar spiral structure with the non-uniform overall outer diameter.

Further, the ratio between the maximum outer diameter A and the minimum outer diameter B of the planar spiral of the main body occlusion structure 31 when deployed is not too small, and if not too small, it is not effective to occlude irregular aneurysms. Preferably, the ratio of the minimum mesh tube diameter to the maximum mesh tube diameter of the main body plugging structure 31 is not less than 1: 2, so that the ratio of the maximum outer diameter A to the minimum outer diameter B of the planar spiral of the main body blocking structure 31 when being unfolded is 1.5-1.8. As in the example of fig. 4, the ratio between the maximum outer diameter a and the minimum outer diameter B of the planar spiral of the body occluding structure 31 when deployed is 1.8.

As mentioned above, the aneurysm occlusion device 30 preferably further comprises a distal guiding structure 32, wherein a proximal end of the distal guiding structure 32 is connected to a distal end of the main body occlusion structure 31, i.e. the distal guiding structure 32 is disposed entirely outside the main body occlusion structure 31 and at a distal end of the main body occlusion structure 31. Likewise, the distal guide structure 32 has a helical expanded state and a compressed state for delivery from within the vessel to the aneurysm. The pushout microcatheter will self-return to the deployed state when the distal guide structure 32 is in the compressed state within the microcatheter. The helix of the distal guide structure 32 when deployed may be a planar helix (i.e., a two-dimensional helix) or a three-dimensional helix. The spiral direction of the distal guiding structure 32 and the spiral direction of the main body blocking structure 31 may be the same or different, and preferably, the spiral direction of the distal guiding structure 32 and the spiral direction of the main body blocking structure 31 are the same.

The distal guide structure 32 may have a helical configuration with a uniform or non-uniform distribution of outer diameter when deployed, such as a 2-turn regular elliptical helix in fig. 4. The number of spirals of the distal guide structure 32 during deployment is also set based on the size of the aneurysm and is therefore not limited to 2 spirals. For small aneurysms, a smaller number of helical turns of the distal guide structure 32 may be used, while for larger sizes, a larger number of helical turns of the distal guide structure 32 may be used.

The distal guiding structure 32 is generally a slender linear structure when compressed in the microcatheter, and the outer diameter of the spiral body is much smaller than that of the mesh tube of the main body plugging structure 31. On one hand, the distal guiding structure 32 plays a guiding role in the initial stage of release of the main body occlusion structure 31, that is, the spiral structure of the distal guiding structure 32 can guide the main body occlusion structure 31 to rotate in the aneurysm cavity and sequentially cover along the inner wall of the aneurysm until the main body occlusion structure 31 is completely released; on the other hand, after the main body occlusion structure 31 is released, the distal guiding structure 32 internally supports the main body occlusion structure 31 to a certain extent, so that the overall stability of the whole hemangioma occlusion device is increased when a large aneurysm is plugged, and the hemangioma occlusion device is not easily compressed and displaced. And because the external diameter of the spiral body of the far-end guide structure 32 is small, the far-end guide structure 12 is relatively flexible on the whole, and the impact influence of the whole hemangioma plugging device on the tumor wall can be reduced. In addition, the profile shape of the helical structure of the distal guide structure 32 in the deployed state may be other regular or irregular helical structures besides the irregular elliptical helical structure shown in fig. 4, and this is not particularly limited.

The distal end guide structure 32 may be integrally formed with the main body plugging structure 31, for example, the same net tube may be formed by winding, compressing and shaping the same net tube in a rotating manner, so that one net tube is integrally formed into a structure with a long and thin distal end, an enlarged middle part and a compressed proximal end. Of course, in other embodiments, the distal guiding structure 32 may also be formed separately from the main body blocking structure 31, that is, after the two are formed separately, the distal guiding structure 32 is fixed at the distal end of the main body blocking structure 31. Compared with the split molding, the integral molding manufacturing process is simpler, and additional connection processing is not required to be performed at the far end of the main body plugging structure 31 and the near end of the far end guide structure 32.

Further, the maximum plane height of the hemangioma occlusion device 30 when deployed is not less than 1/4 of the maximum outer diameter A of the planar spiral of the main body occlusion structure 31 when deployed, more preferably the maximum plane height is 1/3-2/3 of the maximum outer diameter A of the planar spiral of the main body occlusion structure 31 when deployed. As one specific example, the maximum planar height of the aneurysm occlusion device 30 when deployed is 0.5 times the maximum outer diameter a of the planar spiral of the body occlusion structure 31 when deployed. It should be understood that the maximum planar height of the hemangio-occlusion device 30 when deployed refers to the maximum height of the entire hemangio-occlusion device in a plane perpendicular to the plane of the planar spiral, which is perpendicular to the plane of the neck of the tumor.

The distal guide structure 32 has at least one helix, and the outer diameter of the first helix from its distal end is the same as the inner diameter of the subsequent helix, so that the subsequent helix can wrap around the previous helix. Further, the maximum outer diameter D of the helix of the distal guide structure 32 when deployed is no greater than 1/2 of the maximum outer diameter A of the planar helix of the body blocking structure 32 when deployed. As in this embodiment, the maximum outer diameter D of the helix of the distal guide structure 32 when deployed is 1/2 the maximum outer diameter A of the planar helix of the body blockage structure 31 when deployed.

With continued reference to fig. 4, the proximal end a of the main body occlusion structure 31 is preferably bound and fixed by the proximal visualization mark, and the proximal ends of the braided filament ends are bound and fixed together to form an atraumatic proximal end a, which avoids affecting the tumor wall. Preferably, the distal end b of the distal guide structure 32 (i.e., the distal end of the entire device) is held captive by the distal visualization marker, holding the distal ends of the braided filaments together to form an atraumatic distal end b. The proximal visualization marker and the distal visualization marker may be visualization cannulas.

In a specific embodiment, as shown in fig. 4, the main body occluding structure 31 has 2 generally elliptical planar spirals when deployed, the distal guide structure 32 has 2 generally elliptical spirals when deployed, and the ratio between the maximum outer diameter a and the minimum outer diameter B of the planar spiral of the main body occluding structure 31 when deployed is 1.8, the maximum planar height of the hemangioma occlusion device 30 when deployed is 0.5 times the maximum outer diameter a of the planar spiral of the main body occlusion structure 31 when deployed, the maximum outer diameter D of the helix of the distal guide structure 32 when deployed is 1/2 the maximum outer diameter a of the planar helix of the body blockage structure 31 when deployed, the aneurysm occlusion device 30 can be adapted to occlude an aneurysm in the form of a long sphere, and the major axis direction (i.e., the direction of the maximum outer diameter) of the main body occlusion structure 31 is perpendicular to the plane of the neck of the aneurysm.

< example four >

The utility model discloses preferred embodiment four still provides a hemangioma plugging system, including little pipe and the hemangioma plugging device that any embodiment provided, hemangioma plugging device is in compressed in the little pipe, and breaking away from can also resume into the state of expanding of spiral shape behind the little pipe.

The utility model discloses preferred embodiment still provides a hemangioma shutoff treatment device, including the hemangioma plugging device that push rod and any embodiment provided, push rod detachable connect in hemangioma plugging device the near-end of netted expanding structure.

The push rod is disengageable from the proximal end of the mesh-like expandable structure. The preferred tangential direction along the spiral line of the plane spiral of main part block structure when expanding of propelling movement pole extends for the lateral surface of the biggest spiral of main part block structure covers at the tumour neck mouth when the propelling movement releases, promptly, the neck setting that hemangioma was strideed across to the lateral surface of main part block structure, thereby improves the coverage rate of tumour neck mouth, and avoids main part block structure's near-end hernia, and ensures that main part block structure's near-end is not located the middle part of tumour neck mouth and avoids influencing the healing of tumour neck. The releasing mode between the pushing rod and the main body plugging structure can adopt heating releasing, electrical releasing, mechanical releasing or hydrolysis releasing and the like in the prior art, and is not limited in this respect. The push rod is used for pushing the hemangioma plugging device to be separated from the micro-catheter, so that the release of the hemangioma plugging device in the aneurysm is realized.

The operation of the hemangioma occlusion device of the present invention will be further described, and the planar spiral distal guiding structure is taken as an illustration, but it should be understood by those skilled in the art that when the distal guiding structure is a three-dimensional spiral, the operation can still be performed with reference to the following method.

First, the aneurysm occlusion device is loaded into the microcatheter before the delivery, and after the loading, the aneurysm occlusion device is compressed and stretched, and at this time, the aneurysm occlusion device is elongated and formed in a linear shape, so that the entire aneurysm occlusion device can be delivered into a microcatheter having a small inner diameter while the radial dimension thereof is small. And then, after the distal end of the microcatheter is positioned at the proximal end of the aneurysm, the aneurysm occlusion device can be released, in the releasing process, the distal guide structure can be released in the aneurysm firstly by pushing towards the distal end by means of the pushing rod or withdrawing towards the proximal end by means of the microcatheter, and the distal guide structure is rotationally molded in the aneurysm along a preset shape. And then along with further propelling movement hemangioma plugging device, main part plugging structure begins the release, under the guide of distal end guide structure, main part plugging structure continues rotational moulding on the plane of packing that distal end guide structure constitutes, and distal end guide structure's lateral surface meets with main part plugging structure's medial surface in proper order, and the spiral external diameter is constantly increased, until main part plugging structure expandes completely, makes hemangioma plugging device's the most spiral lateral surface cover inside the tumor neck, makes whole device stably coil in the hemangioma, forms stable and compliant packing. And finally, after the completion of the plugging is confirmed, the pushing rod can be electrolyzed to separate from the main body plugging structure, and the microcatheter and the pushing rod are withdrawn, so that the plugging is completed.

According to the utility model discloses technical scheme, it has following advantage:

(1) the hemangioma plugging device can form a continuous dense net covering surface at the neck of the aneurysm through the side wall of the net pipe of the main body plugging structure, and can adapt to more forms and positions of the aneurysm, especially the uneven outer diameter of the net pipe of the main body plugging structure can improve the compliance of the hemangioma plugging device to the cavity of the irregular aneurysm and improve the forming effect, so that the hemangioma plugging device is particularly suitable for plugging irregular spherical or oblate spherical aneurysms and the like, and the treatment range of the hemangioma plugging device is improved;

(2) the spiral structure of the hemangioma plugging device can improve the space division in the aneurysm cavity, promote the turbulence effect and the thrombus formation, promote the formation of the thrombus in the aneurysm and accelerate the embolization of the aneurysm;

(3) the far-end guide structure of the hemangioma plugging device is spiral, so that the far-end riveting point is in a tumor cavity and is not in direct contact with a tumor wall, and the influence of the device on the aneurysm wall is reduced; similarly, the proximal rivet point is parallel to the tumor wall and can be pressed between the main body plugging structure and the tumor wall, the coverage of the tumor neck is not influenced, and the stability is good;

(4) the release process of the hemangioma plugging device is simple, the dependence on the personal aneurysm embolization experience of a doctor in the operation process can be reduced, and the operation time is reduced;

(5) the outer side surface of the main body plugging structure can be used for covering the tumor neck, so that the device is non-oriented to a certain extent, and the multi-layer dense-mesh structure can improve the tumor neck coverage rate and reduce the number of instruments required by the operation;

(6) the hemangioma plugging device is completely positioned in the aneurysm, so that the use of double antiplatelet medicaments can be avoided;

(7) the hemangioma plugging device gradually completes plugging through the radial size and can reach more lesion positions through a microcatheter with smaller inner diameter; the device increases the internal turbulence effect while improving the tumor neck coverage.

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

1. A hemangioma occlusion device, comprising a main body occlusion structure in the shape of a mesh tube, said main body occlusion structure having an expanded state in the shape of a planar spiral and a compressed state for delivery from within a blood vessel to the hemangioma, and the outer diameter of the mesh tube of said main body occlusion structure being non-uniform, such that the outer diameter of the planar spiral is non-uniformly distributed when said main body occlusion structure is expanded.

2. The hemangioma occlusion device of claim 1, further comprising a distal guide structure disposed outside the main body occlusion structure, a proximal end of the distal guide structure being connected to a distal end of the main body occlusion structure, the distal guide structure having a helical expanded state and a compressed state for delivery from within a blood vessel to the hemangioma; the spiral direction of the far-end guide structure is the same as the spiral direction of the main body plugging structure.

3. The hemangioma occlusion device of claim 1 or 2, wherein the ratio of the minimum mesh tube diameter to the maximum mesh tube diameter of the main body occlusion structure is not less than 1: 2, the ratio of the maximum outer diameter to the minimum outer diameter of the plane spiral when the main body plugging structure is unfolded is 1.5-1.8.

4. The aneurysm occlusion device of claim 2, wherein the helical outer diameter of the distal guide structure is uniformly or non-uniformly distributed when deployed.

5. The hemangioma occlusion device of claim 2, wherein the maximum planar height of the hemangioma occlusion device when deployed is no less than 1/4 of the maximum outer diameter of the planar spiral when the main body occlusion structure is deployed.

6. The hemangioma occlusion device of claim 5, wherein the maximum planar height of the hemangioma occlusion device when deployed is 1/3-2/3 of the maximum outer diameter of the planar spiral when the main body occlusion structure is deployed.

7. The aneurysm occlusion device of claim 2, wherein the maximum outer diameter of the spiral when the distal guiding structure is deployed is no greater than 1/2 of the maximum outer diameter of the planar spiral when the main body occlusion structure is deployed.

8. The hemangioma occlusion device of claim 2, wherein the distal guide structure and the main body occlusion structure are made from the same mesh tube pre-shaped.

9. The hemangioma occlusion device of claim 1 or 2, wherein the main body occlusion structure has at least one planar spiral when deployed, the planar spiral is formed by winding a mesh tube spiral, and the mesh tube has cross-sections of different shapes and/or sizes when deployed.

10. The hemangioma occlusion device of claim 9, wherein the mesh tube is woven from braided wires having a wire diameter of 0.0008in to 0.002in, a number of the braided wires of 48 to 144, and a maximum outer diameter of 2mm to 8 mm.

11. The hemangioma occlusion device of claim 1 or 2, wherein the maximum outer diameter of the planar spiral when the main body occlusion structure is deployed is between 4mm and 32 mm.

12. The hemangioma occlusion device of claim 1 or 2, wherein the proximal end of the hemangioma occlusion device is captively secured by proximal visualization indicia and/or the distal end of the hemangioma occlusion device is captively secured by distal visualization indicia.

13. A hemangioma occlusion treatment device comprising a hemangioma occlusion device according to any of claims 1-12 and a push rod detachably connected to the proximal end of the main body occlusion structure of the hemangioma occlusion device.

14. The hemangioma occlusion treatment device of claim 13, wherein the push rod extends in a tangential direction of a spiral of the planar spiral when the main body occlusion structure is deployed.

15. A system for aneurysm occlusion comprising the aneurysm occlusion device of any of claims 1-12 and a microcatheter, the aneurysm occlusion device being compressed within the microcatheter and capable of returning to an expanded state upon detachment from the microcatheter.