CN113855145B

CN113855145B - Hemangioma plugging device, hemangioma plugging treatment device and hemangioma plugging system

Info

Publication number: CN113855145B
Application number: CN202111276171.3A
Authority: CN
Inventors: 郭爽; 常孟琪; 郭远益; 潘光亮; 王亦群
Original assignee: Microport Neurotech Shanghai Co Ltd
Current assignee: Microport Neurotech Shanghai Co Ltd
Priority date: 2021-10-29
Filing date: 2021-10-29
Publication date: 2023-06-30
Anticipated expiration: 2041-10-29
Also published as: CN113855145A; WO2023071944A1

Abstract

The invention relates to a hemangioma plugging device, a hemangioma plugging treatment device and a hemangioma plugging system; the hemangioma plugging device comprises a reticular expansion structure and a positioning guide structure, wherein the reticular expansion structure has a plane vortex-shaped expansion state; the positioning guide structure has a three-dimensional spiral expansion state, after the hemangioma plugging device is expanded, one part of the positioning guide structure is spirally arranged in the central cavity of the plane vortex, and the other part of the positioning guide structure is positioned outside the plane vortex, so that the device is integrally stable, stably positioned in a tumor for a long time and difficult to move, and can realize filling and stable support of a tumor cavity through the netlike expansion structure. The invention can realize stable filling, and simultaneously has the advantages of preventing hemangioma from cracking, preventing vascular embolism, improving the coverage rate of the neck of the tumor, promoting the formation of thrombus in the tumor, accelerating the embolism of the hemangioma, and the like.

Description

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

Technical Field

The invention relates to the technical field of medical equipment, in particular to a hemangioma plugging device, a hemangioma plugging treatment device and a hemangioma plugging system.

Background

Saccular aneurysms are the most common type of aneurysm, accounting for 80% to 90% of all intracranial aneurysms, the most common cause of non-invasive subarachnoid hemorrhage (SAH), which, depending on the severity of the hemorrhage, can lead to permanent neurological deficit or death. Currently, there are three main approaches to treating aneurysms: surgical clips, coil embolization, and blood flow guides. The spring coil embolism and the blood flow guiding device are intravascular interventional treatment, can avoid brain tissues, directly reach lesions and have the characteristic of micro-trauma, so that the device becomes the main stream for treating intracranial aneurysms.

Coil embolization is a minimally invasive procedure in which preformed coils are released from a catheter into an aneurysm sac to fill, resulting in slow and non-laminar blood flow within the aneurysm sac. Disruption of blood flow within the aneurysm sac causes the formation of a clot and excludes further blood flow into the structure, thereby preventing further expansion of the aneurysm. When the embolism is successful, the thrombus may eventually become covered by a layer of endothelial cells, reforming the internal vessel wall. However, not all coil embolization procedures are successful, which may result in recanalization of the aneurysm, and may require implantation of additional devices, such as auxiliary stents and blood flow guides. The use of multiple devices increases the surgical time, cost of treatment, and the likelihood of adverse events. Meanwhile, the spring coil embolization has certain requirements on the technology and experience accumulation of doctors. In recent years, the application of blood flow guiding devices has significantly improved the long-term efficacy of large, giant aneurysms and greatly reduced the use of coils. The computer hemodynamic 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 guides has led patients to rely on dual antiplatelet therapy for long periods of time with the risk of post-operative bleeding complications; at the same time there is a risk of occluding the branch vessel with the blood flow guiding device for the bifurcation aneurysm. In addition, there is a certain risk of delayed rupture after treatment of part of the large aneurysm.

There are some new type of disposable embolism apparatuses, which are generally prepared from shape memory materials and prefabricated and shaped into a sphere, column or disc, and are delivered through a catheter, and after reaching a specific position, the new type of disposable embolism apparatuses are pushed out of a sheath tube and self-expanded to return to the prefabricated shape, so as to achieve the purpose of sealing an aneurysm. For example, a first embolic apparatus 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 the treatment of the aneurysm is realized by covering the tumor neck by a proximal dense net. The second embolism apparatus is a three-dimensional net structure formed by a developing wire and a peripheral self-expanding memory alloy, and can be released and recovered through a microcatheter like a spring ring, and can be in a spherical structure when being stuffed in a tumor, thereby playing a role of turbulence. A third embolic device is also provided, woven from a double layer nickel titanium alloy, similar to the first embolic device in principle, but without a rivet point at the distal end of the device. The fourth embolic device is formed by weaving double-layer memory alloy, is disc-shaped without limitation, can be limited by tumor walls to be tulip-shaped when released in a tumor body, can be stably arranged at the lower part of the tumor body and cover the tumor neck, and further plays a role in reconstructing hemodynamics. However, the proximal rivet design of the first embolic device provides a symmetrical structure to orient the device for neck coverage, is primarily used for treating bifurcated wide-diameter aneurysms, and is particularly useful for regular aneurysms. Moreover, the design of the riveting point of the first embolic device at the distal end has impact on the tumor wall, which easily causes the rupture of the tumor wall and the bleeding of the aneurysm. And in some cases, the proximal rivet of the first embolic device may be squeezed by the tumor wall to herniate the parent artery, affecting the endothelialization process of the tumor neck. In addition, the first embolic device is typically in the form of a single sphere or cylinder, with a large contact area, but insufficient support, poor long-term stability within the lumen of the tumor, and easy displacement of the device. The second type of embolism apparatus is shaped into a three-dimensional net structure by a plurality of sheet-shaped nets, and is similar to a sphere, and because the friction force between the three-dimensional net structures and the tumor wall is large, the molding stability of the apparatus in the tumor is poor, the apparatus is not easy to recover into a preset shape, the filling effect is affected, and the apparatus is complex to operate due to the fact that the apparatus is matched with a spring ring. The third embolic device works substantially similarly to the first embolic device and thus suffers from the same problems. The proximal rivet point of the fourth embolic device is also easily extruded by the tumor wall to herniate into the parent artery, so that the device is suitable for the apical aneurysm, and the position of the device needs to be adjusted and placed repeatedly, otherwise, the stability of the device in the tumor is affected, and therefore, the efficiency is low.

Disclosure of Invention

In order to solve the technical problems, the invention aims to provide a hemangioma plugging device, a hemangioma plugging treatment device and a hemangioma plugging system, which are used for realizing the plugging treatment of hemangioma, can be positioned more stably in the tumor, and have high embolism efficiency and small damage to the tumor wall.

To achieve the above object, according to a first aspect of the present invention, there is provided an hemangio-sealing device comprising:

a mesh expanded structure having a planar, swirling expanded state and a compressed state for endovascular delivery to a hemangioma; the method comprises the steps of,

a positioning guide structure having a proximal end connected to a distal end of the mesh-like dilating structure, the positioning guide structure having a three-dimensional helical dilating state and a compressed state for endovascular delivery to a hemangioma;

after the hemangioma plugging device is configured to be expanded, one part of the positioning guide structure is spirally arranged in a central cavity of a plane vortex of the reticular expansion structure, the other part of the positioning guide structure is spirally arranged outside the plane vortex of the reticular expansion structure, and the spiral direction of the positioning guide structure is the same as that of the reticular expansion structure.

Optionally, the expanded cross-section of the mesh expansion structure has a width in a direction perpendicular to the plane of the vortex that is greater than the width in the remaining directions.

Optionally, the expanded cross-sectional shape of the mesh-like expanded structure is elliptical, the major axis of the ellipse being perpendicular to the plane of swirl and the minor axis of the ellipse being parallel to the plane of swirl.

Optionally, the mesh expansion structure comprises a proximal portion, a middle portion and a distal portion connected axially in sequence; the distal end portion is connected to the positioning guide structure;

the expanded cross section area of the middle part is the same, and the width of the expanded cross section of the middle part in the direction perpendicular to the vortex plane is larger than the width of the expanded cross section of the middle part in the other directions; the expanded cross-sectional area of the distal portion increases in sequence from the distal end to the proximal end, and the expanded cross-sectional area of the proximal portion increases in sequence from the proximal end to the distal end.

Optionally, the area of the cross section of the expanded mesh-shaped expansion structure repeatedly increases and decreases from the proximal end to the distal end, or the area of the cross section of the expanded mesh-shaped expansion structure increases and decreases from the proximal end to the distal end sequentially.

Optionally, the expanded cross-sectional shape of the mesh expansion structure is a flattened shape or a non-flattened shape.

Optionally, the outer diameters of the expanded positioning guide structures are the same, or the outer diameters of the expanded positioning guide structures are sequentially increased from the distal end to the proximal end and then sequentially decreased.

Optionally, an included angle between each layer of spiral after the positioning guide structure is expanded and the cross section of the positioning guide structure is 10-60 degrees, so that adjacent layers of spirals of the positioning guide structure are attached.

Optionally, the mesh expansion structure comprises a proximal portion, a middle portion and a distal portion connected axially in sequence; the distal end portion is connected to the positioning guide structure; the cross-sectional area of the intermediate portion after expansion is greater than the cross-sectional areas of the proximal and distal portions, and the axial length of the intermediate portion after expansion is no less than 70% of the total length of the mesh expansion structure after expansion.

Optionally, the expanded cross-sectional areas of the intermediate portion are the same, the expanded cross-sectional areas of the distal portion increase in sequence from the distal end to the proximal end, and the expanded cross-sectional areas of the proximal portion increase in sequence from the proximal end to the distal end.

Optionally, the mesh-like expanded structure is a braided structure braided from braided filaments, and the intermediate portion has a braid density that is greater than the braid densities of the proximal and distal portions.

Optionally, the number of braided filaments of the proximal and distal portions is half the number of braided filaments of the intermediate portion.

Optionally, the number of turns of the spiral after the positioning guide structure is expanded is not more than 5.

Optionally, the number of spiral turns after the positioning guide structure is expanded is 1.5-3.

Optionally, the distal end of the positioning guide structure is connected to a length of spring structure.

Optionally, the maximum outer diameter of the positioning guide structure after expansion is smaller than the maximum outer diameter of the net-shaped expansion structure after expansion.

Optionally, the maximum outer diameter of the expanded positioning guide structure is less than or equal to 1/2 of the maximum outer diameter of the expanded mesh-like expanded structure.

Optionally, the number of turns of the helix after expansion of the mesh expansion structure is no more than 3.

Optionally, the number of spiral turns of the expanded reticular expansion structure is 1.1-1.5.

Optionally, the cross-sectional shape of the expanded mesh-like expanded structure is elliptical, the major axis of the ellipse is perpendicular to the vortex plane, the minor axis of the ellipse is parallel to the vortex plane, the major axis length of the inner spiral of the expanded mesh-like expanded structure is smaller than the major axis length of the outer spiral adjacent to the inner spiral, and the minor axis length of the inner spiral of the expanded mesh-like expanded structure is smaller than the minor axis length of the outer spiral adjacent to the inner spiral.

Optionally, the mesh expansion structure comprises a proximal portion, a middle portion and a distal portion connected axially in sequence; the distal portion is connected to the positioning guide, and the cross-sectional area of the intermediate portion is greater than the cross-sectional areas of the proximal and distal portions; wherein the major axis length of the oval shape of the intermediate portion is not less than 1/3 of the maximum outer diameter of the expanded mesh-like expanded structure.

Optionally, the mesh-shaped expanding structure and the positioning guide structure are integrally woven and formed.

Optionally, at least 1/2 turn of the spiral after the positioning guide structure is expanded is arranged in the central cavity of the plane vortex of the net-shaped expansion structure.

Optionally, the distal end of the mesh expansion structure is fixedly connected to the distal development ring and/or the proximal end of the mesh expansion structure is fixedly connected to the proximal development ring.

Optionally, the mesh-shaped expansion structure is formed by weaving braided wires, the braided wires are made of shape memory materials, the diameters of the braided wires are 0.0008-0.002 in, the total number of the braided wires is 48-144, the diameter of the expanded mesh-shaped expansion structure is 2-10 mm, and the maximum outer diameter of the expanded mesh-shaped expansion structure is 3-25 mm.

Alternatively, the mesh-like expansion structure is woven from developable braided filaments, or the mesh-like expansion structure is woven from a mixture of developable braided filaments and non-developable braided filaments.

Optionally, the central axis of the expanded positioning guide structure is perpendicular to the vortex plane of the expanded reticular expansion structure, and the central axis of the expanded reticular expansion structure coincides with or is parallel to the central axis of the expanded positioning guide structure.

To achieve the above object, according to a second aspect of the present invention, there is provided a hemangio-occlusion treatment device comprising any one of the hemangio-occlusion devices and a push rod connected to a proximal end of the hemangio-occlusion device.

Optionally, the pushing rod extends along a tangential direction of a spiral line of the planar vortex when the mesh-shaped expanding structure is in the expanded state.

To achieve the above object, according to a third aspect of the present invention, there is provided a hemangio-occlusion system, =comprising any one of the hemangio-occlusion devices and a microcatheter, wherein the mesh-like dilating structure and the positioning guiding structure are compressed within the microcatheter and are also capable of returning to a dilating state of a predetermined shape after being detached from the microcatheter.

Optionally, the microcatheter has an inner diameter of 0.017 inch, 0.021 inch, or 0.027 inch.

To achieve the above object, the present invention also provides a method for treating hemangioma, wherein the neck of the hemangioma opens into a blood vessel, the method comprising:

placing any hemangioma plugging device in the hemangioma, releasing a positioning guide structure in the hemangioma, enabling the positioning guide structure to rotate in the hemangioma to form and recover to a three-dimensional spiral shape, then further pushing the reticular expansion structure to enable the reticular expansion structure to start to release, enabling the reticular expansion structure to continue rotating to form by taking the positioning guide structure as a central shaft until the reticular expansion structure is completely unfolded to be in a plane vortex shape, and enabling a central cavity of a plane vortex of the reticular expansion structure to wrap a part of spiral of the positioning guide structure.

Optionally, the method further comprises:

when the mesh-like expanded structure is fully deployed within a aneurysm, the proximal end of the mesh-like expanded structure is parallel to the tumor wall of the aneurysm and does not herniate the blood vessel.

Optionally, the method further comprises:

The mesh-like expanded structure is caused to tamponade both in a tamponade plane of the lumen of the tumor and in a direction perpendicular to the tamponade plane as the mesh-like expanded structure is released within the hemangioma. This packing approach can expand the packing height to accommodate larger tumor cavity sizes.

The hemangioma plugging device, the hemangioma plugging treatment device and the hemangioma plugging system provided by the invention have the following advantages:

the hemangioma plugging device is actually a spiral structure formed by compounding planar vortex and three-dimensional spiral, and the three-dimensional spiral can play a role of a central shaft, so that the device is more stable and not easy to turn over in the releasing process, the influence of the device on the aneurysm is reduced, and the rupture bleeding risk is reduced. The plane vortex structure is unoriented, the friction force between the inner layer and the outer layer is large, the neck coverage rate is high, the device is more stable, and the displacement is not easy to occur. Meanwhile, the multilayer spiral composite structure enables intratumoral molding to be more stable, and the multilayer dense net structure can improve the embolic density and reduce the number of instruments required by operation. In addition, the hemangioma plugging device provided by the invention is completely positioned in an aneurysm, so that the use of double antiplatelet medicines can be avoided, the device can improve the neck coverage of the aneurysm, simultaneously increase the internal turbulence effect, promote the formation of thrombus in the aneurysm, accelerate the embolism of the aneurysm, and have high embolism effect and high embolism efficiency. In addition, the hemangioma plugging device provided by the invention is simple to release, can reduce the dependence on the personal aneurysm embolism experience of doctors in the operation process, and can reduce the operation time.

The cross section of the expanded reticular expansion structure in the hemangioma plugging device provided by the invention is wider than the widths of other directions in the direction vertical to the vortex plane, for example, the expanded reticular expansion structure is elliptical, the long axis of the expanded reticular expansion structure is vertical to the vortex plane, and the short axis of the expanded reticular expansion structure is parallel to the vortex plane.

Drawings

FIG. 1 is a top view of the expanded configuration of a preferred embodiment of the vascular occlusion device of the present invention wherein the positioning guide structure comprises 1.5 turns of a helix and the mesh expansion structure comprises 1.5 turns of a helix;

FIG. 2 is an elevation view of a preferred embodiment of the present invention after expansion, wherein the positioning guide structure comprises 1.5 turns of a helix and the net-like expansion structure comprises 1.5 turns of a helix;

FIG. 3 is a schematic view showing the state of endovascular delivery of a vascular occlusion device to an aneurysm via a microcatheter, wherein a positioning guide structure and a mesh-like dilating structure are compressed into a linear structure within the microcatheter, in accordance with a preferred embodiment of the present invention; the whole shape of the linear structure is like a long chain, the net-shaped expansion structure restores the plane vortex in the expansion state, the positioning guide structure restores to a three-dimensional spiral shape, and the whole device can be in a straight line shape when being stretched;

FIG. 4 is a state diagram of an example of an embodiment of the invention in which the stent is not fully released within the aneurysm, wherein a portion of the mesh-like expanded structure is rotated about a three-dimensional helical structure;

FIG. 5 is a state diagram of a complete release of a preferred embodiment of the endovascular occlusion device in a tumor, wherein a portion of the positioning guide structure is disposed within the central lumen of the planar scroll structure and the remainder of the positioning guide structure is disposed outside of the planar scroll structure;

FIG. 6 is a view showing the outer dense mesh of the mesh-like expanded structure of the vascular occlusion device covering the neck of a tumor in accordance with a preferred embodiment of the present invention;

FIG. 7 is a top view of another preferred embodiment of the expanded configuration of the vascular occlusion device of the present invention wherein the positioning guide structure comprises 2 turns of a helix and the mesh expanded configuration comprises 1 turn of a helix;

fig. 8 is a top view of another preferred embodiment of the expanded configuration of the vascular occlusion device of the present invention wherein the positioning guide structure comprises 2 turns of a helix and the mesh expansion structure comprises 2 turns of a helix.

The reference numerals are explained as follows:

10-hemangioma plugging device; 11-a reticulated expansion structure; a proximal end of the 111-mesh expansion structure; 112-a distal end of a mesh-like dilating structure; 110-the outer dense mesh surface of the mesh-like expanded structure; 113-a proximal portion; 114-an intermediate portion; 115-a distal portion;

12-positioning and guiding structure;

20-pushing a rod;

30-aneurysms; 31-tumor neck;

40-microcatheter;

d1—maximum outer diameter of the expanded mesh-like expanded structure; d2-maximum outer diameter of the positioning guide structure after expansion; d-diameter of the intermediate portion after expansion; a is the major axis of ellipse; b-elliptical short axis; p-vortex plane; alpha-helical downlink angle.

Detailed Description

The invention will be further described in detail with reference to the accompanying drawings, in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the 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. The term "plurality" is generally employed in its sense including two or more unless the content clearly dictates otherwise. The term "plurality" is used generally in a sense including an indefinite number unless the content clearly indicates otherwise. The term "proximal" generally refers to an end proximal to the operator of the instrument; "distal" is the end opposite "proximal" and "distal" generally refers to the end of the instrument that first enters the body, unless the context clearly indicates otherwise. Herein, "maximum outer diameter of the mesh-like expanded structure" means the maximum diameter of the mesh-like expanded structure on a projection plane perpendicular to the plane vortex central axis after expansion; the "maximum outer diameter of the positioning guide structure" means the maximum diameter of the positioning guide structure on a projection plane perpendicular to the central axis of the three-dimensional spiral after the positioning guide structure is stretched.

Fig. 1 is a structural plan view of an expanded hemangio-sealing device 10 of a preferred embodiment of the present invention, and fig. 2 is a front view of an expanded hemangio-sealing device 10 of a preferred embodiment of the present invention.

As shown in fig. 1 and 2, the present embodiment provides a vascular occlusion device 10 for effecting occlusion treatment of vascular tumors, including but not limited to intracranial aneurysms, which can be bifurcated aneurysms or lateral aneurysms. In practical use, the aneurysm occlusion device 10 is entirely disposed within the aneurysm, and the proximal end does not enter the parent artery, and does not require long-term administration of dual antiplatelet agents, while the embolization is efficient, reducing the requirements for physician skill and experience, and does not require use with other instruments, reducing the risk of developing ischemic complications, and reducing the surgical time.

In the following description, the treatment of a lateral aneurysm is mainly described as an illustration to easily achieve the sealing treatment of the aneurysm, but one skilled in the art will appreciate that the sealing device 10 can also be applied to the sealing treatment of other hemangiomas.

The hemangio-occlusion device 10 specifically comprises a net-like dilating structure 11 and a positioning guiding structure 12. The mesh expanded structure 11 has a planar, swirling expanded state and a compressed state for endovascular delivery to a hemangioma; the positioning guide structure 12 has a three-dimensional helical expanded state and a compressed state for endovascular delivery to a hemangioma; the spiral direction of the three-dimensional spiral after the expansion of the positioning guide structure 12 is the same as the spiral direction of the plane vortex after the expansion of the net-shaped expansion structure 11. The spiral direction here means only counterclockwise or clockwise, and does not limit the change in the three-dimensional direction of space; the spiral directions are the same, so that the positioning guide structure 12 can effectively drive the reticular expansion structure 11 to be spirally arranged in the tumor cavity, the reticular expansion structure 11 can be uniformly distributed according to the shape of the tumor wall, and the problem that the tumor neck is incompletely covered due to extrusion deformation of the reticular expansion structure 11 caused by friction of the tumor wall is avoided.

In addition, the central axis of expansion of the positioning guide structure 12 may be perpendicular or non-perpendicular to the vortex plane of the expanded mesh expansion structure 11. The central axis of the expanded reticular expansion structure 11 and the central axis of the expanded positioning guide structure 12 can be coincident or not, and can be parallel or not. That is, it is sufficient to ensure that a part of the three-dimensional spiral structure after the expansion of the positioning guide structure 12 is not in the same plane as the plane vortex. In a specific embodiment, the central axis of the expanded positioning guide structure 12 is perpendicular to the vortex plane of the expanded mesh-shaped expansion structure 11, and the central axis of the expanded mesh-shaped expansion structure 11 coincides with or is parallel to the central axis of the expanded positioning guide structure 12. In addition, the proximal end of the positioning guide structure 12 is connected to the distal end of the mesh-like expanded structure 11, and both are preferably integrally woven. It should be understood that the entire positioning guide structure 12 is disposed outside the distal end of the mesh-like expanded structure 11, that is, the positioning guide structure 12 is not disposed at a portion within the mesh body of the mesh-like expanded structure 11, and that a portion of the positioning guide structure 12 described below is spirally disposed within the central cavity of the planar vortex of the mesh-like expanded structure 11 means that the mesh body of the mesh-like expanded structure 11 encloses a portion of the positioning guide structure 12 during formation of the planar vortex, but is not disposed within the mesh body of the mesh-like expanded structure 11.

When the hemangioma plugging device 10 is expanded, a part of the positioning guide structure 12 is spirally arranged in the central cavity of the plane vortex of the reticular expansion structure 11, and the other part of the positioning guide structure 12 is spirally arranged outside the plane vortex of the reticular expansion structure 11, so that the positioning guide structure 12 performs positioning guide, and the reticular expansion structure 11 performs supporting, tumor cavity filling and tumor neck plugging. More specifically, the positioning guide structure 12 can make the whole device stable, can stably position for a long time in the tumor and is not easy to move, and the outer dense net surface of the net-shaped expansion structure 11 is distributed along the outline of the tumor cavity while covering the tumor neck, so that the filling and the supporting are realized simultaneously, the embolism effect is good, and the embolism efficiency is high.

In more detail, the hemangioma plugging device 10 of the invention can provide continuous, high metal coverage rate and high mesh density coverage at the tumor neck through the close mesh of the mesh-shaped expansion structure 11, and has good plugging effect; meanwhile, the composite structure of the planar vortex and the three-dimensional spiral can reduce the influence of the far and near ends of the device on the aneurysm wall and the aneurysm neck covering, namely the far and near ends cannot damage the aneurysm wall, the near ends cannot herniate into the carrying aneurysm artery, a dense net with multiple circles distributed inside and outside the tumor cavity is formed, the space division of the tumor cavity is increased, and the embolism efficiency is improved. Therefore, the hemangioma plugging device 10 of the invention can improve the internal turbulence effect of the aneurysm, promote the formation of thrombus in the aneurysm and accelerate the embolism of the aneurysm while improving the neck coverage rate of the aneurysm. It will be appreciated that in the initial stage of intravascular release, the smaller diameter of the three-dimensional helix structure serves as a guide and as the device is further released, the three-dimensional helix structure serves as a central axis to position the device so that the device does not turn over within the lumen of the tumour and is stably packed, and subsequently the planar vortex structure rotates along the central axis established by the three-dimensional helix structure to form a state of release packing along the outline of the lumen of the tumour so that the device can be stably shaped. In addition, the distal end and the proximal end of the whole device are soft, the distal end and the proximal end are not contacted with the tumor wall, the tumor wall is not impacted, and the damage to the tumor wall is small. And after release is finished, the outer dense net surface of the plane vortex structure contacts with the tumor wall, and the plane vortex structure is of a continuous dense net structure, so that the coverage rate of the tumor neck is high, the blocking effect is good, and the plane vortex structure is dispersed in stress and is not easy to shift, and stable filling can be realized.

The hemangio-occlusion device 10 of the present invention is an instrument for vascular intervention and is delivered in vivo via a microcatheter 40. To this end, an embodiment of the present invention also provides a vascular occlusion system including the vascular occlusion device 10 and the micro catheter 40 (refer to fig. 3 and 4), wherein the mesh-shaped expanding structure 11 and the positioning guide structure 12 are compressed in the micro catheter 40 and are also restored to an expanded state of a predetermined shape after being detached from the micro catheter 40. Optionally, the microcatheter 40 has an inner diameter of 0.017 inch, 0.021 inch, or 0.027 inch. Meanwhile, the invention also provides a hemangio plugging treatment device, which comprises the hemangio plugging device 10 and a pushing rod 20, wherein the pushing rod 20 is connected with the proximal end of the hemangio plugging device.

The operation of the vascular occlusion device 10 is described with reference to fig. 3-6:

as shown in fig. 3, microcatheter 40 is delivered intravascularly after loading of the aneurysm occlusion device 10 until the distal end of microcatheter 40 is positioned at aneurysm 30;

as shown in fig. 4, after the distal end of the microcatheter 40 is positioned at the aneurysm 30, pushing the hemangio-sealing device 10 to the distal end of the microcatheter 40 by using the pushing rod 20, so that the positioning guide structure 12 is released and formed in the aneurysm 30 first, and then pushing the hemangio-sealing device 10 is continued, so that the net-shaped expanding structure 11 is further rotated and formed on the basis of the positioning guide structure 12;

Finally, as shown in fig. 5, the net-shaped expanding structure 11 is distributed along the outline of the tumor cavity to form planar vortex and fill the whole aneurysm 30, and a part of spiral of the positioning guide structure 12 is wrapped by the planar vortex, and meanwhile, the outer dense net surface 110 of the net-shaped expanding structure 11 covers the tumor neck 31, as shown in fig. 6;

after the hemangio occlusion device 10 is fully released, the microcatheter 40 and push rod 20 are withdrawn; wherein fig. 5 shows the state in which the aneurysm occlusion device 10 is retained within the aneurysm 30 after withdrawal of the microcatheter 40 and push rod 20.

The proximal end 111 of the mesh expansion structure 11 is in fact releasably connected to the push rod 20. The pushing rod 20 preferably extends along a tangential direction of a spiral line of the planar vortex when the mesh expansion structure 11 is in an expanded state, so that when pushing is released, the outer tight mesh surface 110 of the maximum outer diameter D1 of the mesh expansion structure 11 covers the neck opening 31, that is, the outer tight mesh surface 110 of the mesh expansion structure 11 is disposed across the neck of the aneurysm 30, thereby improving the coverage of the neck opening 31 and avoiding herniation of the proximal end 111 of the hemangio-occlusion device 10, while ensuring that the proximal end 111 of the hemangio-occlusion device 10 is not located in the middle of the neck opening 31 and avoiding affecting healing of the neck. The release manner between the pushing rod 20 and the mesh-shaped expansion structure 11 may be, but not limited to, thermal release, electrolytic release, mechanical release, hydrolytic release, and the like in the prior art. The pushing rod 20 is used for pushing the hemangio-sealing device 10 out of the micro-catheter 40, so that the release of the hemangio-sealing device 10 in the aneurysm 30 is realized.

The net-shaped expansion structure 11 is specifically a woven mesh body woven by woven wires and is preformed into a planar vortex structure. The positioning guide structure 12 is preferably woven and pre-shaped into a three-dimensional spiral structure, and the mesh tube can be woven by woven wires to obtain the mesh tube, and then stretched into a slender shape and then pre-shaped into the three-dimensional spiral structure. In this embodiment, the mesh-shaped expanding structure 11 and the positioning guiding structure 12 are integrally woven, and are shaped into a planar vortex and a three-dimensional spiral respectively. The positioning guide structure 12 may serve as a central shaft of the planar scroll structure when in use, and a part of the spiral of the positioning guide structure 12 is disposed in the central cavity of the planar scroll structure, that is, the planar scroll structure and the nearest part of the spiral of the three-dimensional spiral structure are on the same plane, preferably at least 1/2 of the spiral is disposed in the central cavity of the planar scroll structure after the positioning guide structure 12 expands. Fig. 2 shows that 1 turn of the spiral is disposed within the central cavity of the planar scroll structure after expansion of the positioning pilot structure 12.

The cross-sectional area of the expanded mesh-like structure 11 preferably increases from the proximal end 111 to the distal end 112 and then decreases sequentially, or the cross-sectional area of the expanded mesh-like structure 11 increases from the proximal end to the distal end repeatedly and then decreases, that is, repeatedly becomes larger and smaller. In this embodiment, the net-like expanded structure 11 is configured as a shuttle-like structure after expansion, that is, the net-like expanded structure 11 having both small ends and a large middle. The net-shaped expanding structure 11 with the cross section being changed can increase the flexibility of the device, reduce pushing resistance and impact on the tumor wall, and is more convenient to compress and smaller in compression size.

Referring to fig. 1, in some embodiments, the mesh-like dilating structure 11 comprises a proximal portion 113, a middle portion 114, and a distal portion 115 axially connected in sequence, the distal portion 115 being connected to the positioning guide 12. Wherein the intermediate portion 114 has a cross-sectional area after expansion that is greater than the cross-sectional areas of the proximal portion 113 and the distal portion 115. Further, the cross-sectional area (or diameter) of the distal portion 115 increases sequentially from the distal end 112 to the proximal end 111, the cross-sectional area (or diameter) of the proximal portion 113 increases sequentially from the proximal end 111 to the distal end 1112, and the cross-sectional area of the intermediate portion 114 is the same. Because the size of the woven mesh tube of the positioning guide structure 12 is small, and the size of the woven mesh tube of the middle portion 114 is large, in order to smoothly transition the middle portion 114 and the positioning guide structure 12, the distal end portion 115 with gradually increased cross section is utilized to smoothly transition the positioning guide structure 12, so that smooth transition between the planar vortex structure and the three-dimensional spiral structure is ensured, and the proximal end portion 113 and the distal end portion 114 with changed cross section can increase the flexibility of the whole device and reduce the damage to the tumor wall.

The most proximal braided filaments of the net-like stent 11 may be gathered into a bundle and welded or secured by a proximal sleeve, preferably secured by a proximal sleeve, to avoid damage to the tumor wall by exposure of the filaments. The proximal sleeve is preferably a proximal developer ring that can be developed under X-rays to locate the proximal end of the entire device. In addition, the axial length of the proximal portion 113 and distal portion 115 should not be too long, which would increase the resistance to advancement of the entire device, as well as the length of the inactive tamponade portion. It will be appreciated that distal portion 115 is effectively an inner layer of a planar vortex structure, not in contact with the tumor wall, while proximal portion 113 is positioned substantially near the tumor neck without packing, so that both proximal portion 113 and distal portion 115 are effectively inactive fill segments, which if too long, would affect the length of the device filling the tumor cavity as well as reduce push performance. For this reason, the axial length of the intermediate portion 114 after expansion is preferably not less than 70% of the total axial length of the expanded mesh expansion structure 11. In some embodiments, the expanded axial length of the intermediate portion 114 is 70% of the total axial length of the expanded mesh expanded structure 11. In some embodiments, the expanded axial length of the intermediate portion 114 is 80% of the total axial length of the entire expanded mesh structure 11. In some embodiments, the expanded axial length of the intermediate portion 114 is 90% of the total axial length of the expanded mesh expanded structure 11.

When the hemangioma plugging device 10 is fully expanded, the proximal end portion 113 of the mesh-shaped expanding structure 11 is tightly attached to the middle portion 114, and the middle portion 114 is tightly attached to the distal end portion 115, that is, the inner and outer layers of the planar vortex structure are tightly screwed together, so that a dense mesh structure with tightly arranged inner and outer layers is formed, and the embolism effect is ensured. In order to control the size of the planar vortex, in practical manufacturing, adjacent spirals of the planar vortex-shaped net-shaped expanding structure 11 are preferably closely attached together, for example, the outer wall of the first spiral is attached to the inner wall of the second spiral, and the outer wall of the second spiral is attached to the inner wall of the third spiral, which is suitable for the case of more spirals, so that the net-shaped expanding structure 11 is better formed under the guidance of the positioning guide structure 12. It should be understood that the first spiral of the mesh-like expanded structure 11 refers to a first spiral wound from the most distal end of the mesh-like expanded structure 11.

The cross-sectional shape of the expanded mesh-like expanded structure 11 may be various shapes such as a regular shape such as a circle, an ellipse, etc., or a special-shaped shape, and more preferably the width of the expanded cross-section of the expanded mesh-like expanded structure 11 in the direction perpendicular to the plane of the vortex is larger than the width in the remaining directions. Further, the expanded cross section of the intermediate portion 114 has a width in the direction perpendicular to the plane of the vortex which is greater than the width in the remaining direction, thereby increasing the height of the packed tumor cavity after expansion of the expanded mesh-like expanded structure 11, and thus, it is possible to pack a larger size of tumor cavity.

In some embodiments, as shown in fig. 2, the expanded cross-sectional shape of the mesh-like expansion structure 11 is an ellipse, the major axis a of the ellipse being perpendicular to the plane of swirl P and the minor axis B being parallel to the plane of swirl P. The cross-sectional area of the intermediate portion 114 remains unchanged, i.e., the intermediate portion 114 is a woven mesh tube of equal diameter. In addition to increasing the packing height, the oval middle portion 114 may also increase the friction between the inner and outer coils of the planar scroll structure, making the entire aneurysm plugging device 10 more stable after packing the aneurysm, and not displacing between the inner and outer coils of the planar scroll structure, thereby making the entire aneurysm plugging device more stable.

As the cross-sectional area of the expanded proximal portion 113 increases from the proximal end to the distal end, in some embodiments, the proximal portion 113 may be conically shaped as shown in fig. 1, and in other embodiments, the proximal portion 113 may have an ellipsoidal half of the structure as shown in fig. 7.

Further, the cross-sectional shape of the expanded mesh-like structure 11 may be a flat shape or a non-flat shape. As in some embodiments, the expanded cross-sectional shape of the expanded mesh-like structure 11 is elliptical, wherein the ratio of the length of the major axis a to the length of the minor axis B of the ellipse is not significantly different to form a non-flattened ellipse, as shown in fig. 2, and in other embodiments, the ratio of the length of the major axis a to the length of the minor axis B of the ellipse is significantly different to form a flattened ellipse, i.e., the major axis a is increased and the minor axis B is decreased as compared to the ellipse shown in fig. 2, as shown in particular with reference to fig. 8.

The outer diameters of the expanded positioning guide structures 12 may be the same or sequentially increased from the distal end to the proximal end, or the outer diameters of the expanded positioning guide structures 12 sequentially increase from the distal end to the proximal end and then sequentially decrease, and preferably, the maximum outer diameter D2 of the expanded positioning guide structures 12 is smaller than the maximum outer diameter D1 of the expanded mesh-shaped expansion structures 11. In this embodiment, the outer diameters of the expanded positioning guide structures 12 are the same, so as to reduce the manufacturing difficulty. The positioning guide structure 12 is slender and flexible, the outer diameters of each layer of spiral are preferably the same, the central axis of the whole hemangio-sealing device 10 is formed by a multi-layer three-dimensional spiral structure, and the most distal end of the positioning guide structure 12 can be fixed by a distal end developing ring, so that the distal end of the whole hemangio-sealing device can be developed. Further preferably, after the positioning guide structure 12 is expanded, the descending angle α of each layer of spiral is 10 ° to 60 °, such as 15 °, 20 °, 30 °, etc., so as to reduce the gap between adjacent spirals, so that the adjacent layers of spirals can be closely attached, and the support is better. It will be appreciated that, at the beginning of the procedure for filling an aneurysm, since the maximum outer diameter D2 of the positioning guide 12 is much smaller than the diameter of the aneurysm, the friction with the wall of the aneurysm is small, which can act as a guide; with further packing, the action of the central shaft is developed, and the external planar vortex structure can be released along the rotation of the central shaft, and finally the state of packing along the outline of the tumor cavity is formed. After the filling is completed, the positioning guide structure 12 plays a role of a central shaft and positions the filling position; the outer dense mesh surface of the outer planar vortex structure is distributed along the tumor lumen and covers the tumor neck, with the fusiform or oval shape of the proximal portion 113 being compressed between the mesh body of the intermediate portion 114 and the tumor wall, without herniating into the parent artery and without damaging the tumor wall.

Preferably, the distal end of the positioning guide structure 12 is connected to a section of spring structure, which may be spiral, and has an outer diameter not greater than the maximum outer diameter of the positioning guide structure 12 and a number of spiral turns not greater than the number of spiral turns of the positioning guide structure 12. So configured, the softness of the device upon initial release can be further reduced,

the net-shaped expansion structure 11 is formed by braiding and shaping filaments, the number of the braided filaments is preferably 48-144, and the filament diameter of the braided filaments can be 0.0008-0.002 in, so that a dense net with larger grid density can be constructed, blood flow in a tumor cavity can be effectively blocked, the formation of thrombus in the tumor can be promoted, and the coverage rate of a tumor neck can be improved. Further, the diameter D of the intermediate portion 114 may be selected to be 2mm to 10mm, and the maximum outer diameter D1 of the expanded mesh-like expanded structure 11 may be 3mm to 20mm. The diameter D here refers to the size of the cross-section of the intermediate portion 114. Further, the intermediate portion 114 has a greater braid density than the proximal portion 113 and the distal portion 115 to increase the flexibility of the overall device, reduce trauma to the tumor wall, and avoid rupture and hemorrhage of the aneurysm. The minimum number of braided filaments of the proximal portion 113 and the distal portion 115 may be reduced to half the number of braided filaments of the intermediate portion 114 so that the distal and proximal ends of the hemangio-occlusion device may be more flexible. The braided filaments at the proximal end 111 and distal end 112 of the mesh expansion structure 11 may be welded or embedded in a sleeve.

The overall height of the expanded positioning guide 12 preferably does not exceed the maximum outer diameter D1 of the expanded mesh expanded structure 11 to ensure that the planar vortex structure is able to adequately fill the tumor cavity. In some embodiments, the number of turns of the helix after expansion of the positioning guide 12 is no more than 5, more preferably 1.5 to 3. The maximum outer diameter D2 of the positioning guide structure 12 after expansion is configured to be able to be wrapped by the central lumen of the mesh-like expansion structure 11, i.e., the maximum outer diameter D2 of the positioning guide structure 12 after expansion does not exceed the inner diameter of the mesh-like expansion structure 11. Preferably, the maximum outer diameter D2 of the expanded positioning guide structure 12 is not greater than 1/2 of the maximum outer diameter D1 of the expanded mesh-shaped expansion structure 11, and the spiral outer diameters of each turn of the positioning guide structure 12 are equal.

The number of turns of the helix of the expanded mesh expansion structure 11 preferably does not exceed 3, to avoid increasing the axial length of the overall device, which would increase the size of the delivery device. More preferably, the number of turns of the spiral after the expansion of the mesh expansion structure 11 is 1.1 to 1.5. In the aneurysm, the outer side wall of the inner spiral is connected with the inner side wall of the outer spiral after the mesh-shaped expanding structure 11 is expanded, and the mesh-shaped expanding structure sequentially rotates. In some embodiments, the cross-sectional shape of the mesh expansion structure 11 is elliptical, particularly for the middle portion 114, preferably the elliptical major axis length of the inner layer helix is less than the length of the major axis of its adjacent outer layer helix, and the minor axis length of the inner layer helix is less than the minor axis length of its adjacent outer layer helix, such that the cross-sectional dimension of the largest helix is greater to enable adequate filling of the tumor cavity. Alternatively, the maximum outer diameter D1 of the expanded mesh-like structure 11 is 3-25 mm, wherein the length of the major axis A of the oval shape of the intermediate portion 114 is not less than 1/3 of the maximum outer diameter D1 of the expanded mesh-like structure 11.

As previously described, the mesh expansion structure 11 has a compressed state and an expanded state. When the net-like expansion structure 11 is in an expanded state, the net-like expansion structure 11 has a planar vortex shape; when the mesh-like expanded structure 11 is in a compressed state, the mesh-like expanded structure 11 is conveniently delivered intravascularly to the hemangioma via the microcatheter 40. More specifically, the mesh-like expanded structure 11 has a compressed state when loaded within the microcatheter 40, at which time the mesh-like expanded structure 11 is generally linear in shape with its radial dimension minimized for ease of delivery; when the mesh-like expanded structure 11 is detached from the microcatheter 40, it is elastically expanded by itself to have a plane vortex-like expanded state. Similarly, the positioning guide 12 also has a compressed state and an expanded state. When the positioning guide structure 12 is in an expanded state, the positioning guide structure 12 is restored to a three-dimensional spiral shape as a whole; delivery of the positioning guide structure 12 from within the blood vessel to the aneurysm via the microcatheter 40 is also facilitated when the positioning guide structure 12 is in a compressed state. In more detail, the positioning guide structure 12 has a compressed state when the positioning guide structure 12 is in the microcatheter 40, and at this time, the positioning guide structure 12 has a linear shape with a small radial dimension; when the positioning guide structure 12 is separated from the micro catheter 40, it is elastically expanded by itself to have an expanded state, and in the expanded state, the positioning guide structure 12 is entirely restored to a three-dimensional spiral shape.

In an exemplary embodiment, as shown in fig. 1 and 2, the positioning guide structure 12 comprises 1.5 spirals having a descending angle α of 30 ° after expansion. It should be understood that the downward angle α of the helix is the angle between the helix and the cross section of the positioning guide 12. In some embodiments, as shown in fig. 1 and 2, the expanded mesh expanded structure 11 includes 1.5 spirals having an expanded axial length of the intermediate portion 114 that is 70% of the total length of the expanded mesh expanded structure 11. Fig. 1 and 2 also show that the positioning guide structure 12 and the intermediate portion 114 are smoothly transitionally joined by a distal portion 115 of sequentially varying cross-section, with the proximal portion 113 being fusiform in length and the sum of the axial lengths of the proximal portion 113 and the distal portion 115 after expansion accounting for 30% of the total length of the expanded mesh expanded structure 11. Also shown in fig. 1 and 2 is that the maximum outer diameter D2 of the positioning guide structure 12 after expansion is 1/3 of the maximum outer diameter D1 of the net-like expansion structure 11 after expansion, the cross-sectional shape of the intermediate portion 114 after expansion is elliptical, and the length of the major axis a is 1/2 of the maximum outer diameter D1 of the net-like expansion structure 11.

In another exemplary embodiment, as shown in fig. 7, the positioning guide structure 12 comprises 2 spirals after expansion, the descending angle α of the spirals is 20 °, the expanded mesh expansion structure 11 comprises 1 spiral, and the axial length of the expanded intermediate portion 114 is 80% of the total length of the expanded mesh expansion structure 11. Fig. 7 also shows that the positioning guide structure 12 and the intermediate portion 114 are smoothly transitionally joined by a distal portion 115 having a sequentially varying cross-section, but that the proximal portion 113 is ellipsoidal in shape and that the sum of the axial lengths of the proximal portion 113 and the distal portion 115 after expansion is 20% of the total length of the expanded mesh-like expanded structure 11. Fig. 7 also shows that the maximum outer diameter D2 of the positioning guide structure 12 after expansion is 2/5 of the maximum outer diameter D1 of the net-like expansion structure 11 after expansion, the cross-sectional shape of the intermediate portion 114 after expansion is elliptical, and the length of the major axis a is 3/7 of the maximum outer diameter D1 of the net-like expansion structure 11.

In yet another exemplary embodiment, as shown in fig. 8, the positioning guide structure 12 comprises 2 spirals after expansion and the downward angle α is 15 °, and the mesh-like expansion structure 11 comprises 2 spirals after expansion, wherein the mesh-like expansion structure 11 comprises a shuttle-like distal portion 115, a flat-sheet middle portion 114, and a shuttle-like proximal portion 113, the flat-sheet middle portion 114 comprising 90% of the total length of the expanded mesh-like expansion structure 11. Fig. 8 also shows that the maximum outer diameter D2 of the positioning guide structure 12 after expansion is 1/2 of the maximum outer diameter D1 of the expanded mesh-like expanded structure 11, and the length of the long axis of the expanded flat sheet intermediate portion 114 is 2/3 of the maximum outer diameter of the expanded mesh-like expanded structure 11.

Preferably, the material of the braided wire of the mesh-shaped expanding structure 11 includes a shape memory material, and the shape memory material may be a metal material having a shape memory function, such as nickel-titanium (Ni-Ti) alloy, nickel-titanium-cobalt alloy (Ni-Ti-Co), double-layer composite wire (Ni-ti@pt), and the like. The material of the braided filaments may also be a polymeric material having a 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 a shape memory metal material or a polymer material with a certain shape recovery capability, so that the mesh has the function of memorizing and recovering the original shape. Preferably, the mesh-like expansion structure 11 is woven from developable braided filaments, or the mesh-like expansion structure 11 is woven from a mixture of developable braided filaments and non-developable braided filaments. By the design, the reticular expansion structure 11 can be developed under X rays, elasticity of the reticular expansion structure 11 is guaranteed, and the reticular expansion structure 11 has strong recovery capability and original shape retaining capability. The developing material of the developing braided wire is not particularly limited, and for example, platinum (Pt), platinum iridium (Pt-Ir), au (gold) and the like can be selected. In some embodiments, the braided filaments are a composite structure comprising a sleeve and a core filament, the sleeve surrounding the core filament, the material of the core filament comprising, but not limited to, one or more radiopaque materials such as platinum, iridium, gold, silver, tantalum, tungsten, or the like, or alloys thereof, the sleeve not having developability, the material of the sleeve comprising, but not limited to, one or more combinations of nickel-titanium alloy, nitinol, stainless steel, cobalt-chromium alloy, nickel-cobalt alloy. Preferably, the braided wires of the middle portion 114 are developable, the braided wires of the proximal portion 113 and the distal portion 115 are not developable, and the middle portion 114 adopts the developing material as the braided wires, so that the X-ray developability of the mesh-shaped expanding structure 11 is better, and the safety and accuracy of the operation are improved.

Further, the present invention also provides a method for treating a hemangio-ma, wherein the neck of the hemangio-ma opens into a blood vessel, the method comprising:

the hemangioma plugging device 10 is placed in hemangioma, the positioning guide structure is released in the hemangioma, the positioning guide structure is made to rotate in the hemangioma and restore to be in a three-dimensional spiral shape, then the net-shaped expanding structure is pushed further, the net-shaped expanding structure starts to release, the net-shaped expanding structure continues to rotate and form by taking the positioning guide structure as a central shaft until the net-shaped expanding structure is completely unfolded to be in a plane vortex shape, and a central cavity of a plane vortex of the net-shaped expanding structure wraps a part of the positioning guide structure in a spiral mode.

Optionally, the method further comprises:

when the mesh-like expanded structure is fully deployed within a aneurysm, the proximal end of the mesh-like expanded structure is parallel to the wall of the aneurysm and does not herniate the blood vessel.

Optionally, the method further comprises:

when the net-like expansion structure is released in the hemangioma, the net-like expansion structure is filled both in the filling plane of the lumen of the tumor and in a direction perpendicular to the filling plane, for example, the net-like expansion structure, in particular the middle part, is configured as an ellipse with the major axis perpendicular to the filling plane and the minor axis parallel to the filling plane.

According to the technical scheme provided by the embodiment of the invention, the device can not turn over in the tumor cavity through the positioning guide structure at the far end so as to realize stable filling, the net-shaped expansion structure at the near end rotates along the central shaft constructed by the internal three-dimensional spiral structure to form a state of releasing filling along the outline of the tumor cavity, so that the device can be stably formed, the forming is stable, the filling effect is good, meanwhile, the far end and the near end of the device can not impact the tumor wall, the damage to the tumor wall is small, the outer side surface of the external plane vortex structure contacts the tumor wall, the device is of a continuous dense net structure, the coverage rate of a tumor neck is high, and the device is stressed to be dispersed so as to realize stable support and is not easy to shift. In addition, the cross-sectional area of the proximal portion of the reticulated expansion structure increases from the proximal end toward the distal end, which facilitates compression and attaches to the outer sidewall of the largest spiral of the planar scroll structure, while maintaining the stability of the device within the tumor cavity while reducing impact on the tumor wall. And because of the existence of the internal three-dimensional spiral structure, the friction between the inner vortex and the outer vortex is increased, so that the whole device is more stable, is not easy to shift and deform, and reduces the risk of proximal herniation. In addition, the hemangioma plugging device can provide continuous dense net coverage on the neck of the aneurysm, can improve the effect of reducing blood inflow into the aneurysm and simultaneously provide a scaffold for the endothelialization of the neck of the aneurysm, and particularly has a multilayer dense net structure inside, so that the blood flow resistance in the tumor cavity is increased, the thrombosis can be promoted more quickly, the embolism efficiency of the aneurysm is further improved, and the plugging treatment of the aneurysm is further promoted.

The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present invention.

Claims

1. A hemangio occlusion device, comprising:

2. The device of claim 1, wherein the expanded cross-section of the mesh-like expanded structure has a width in a direction perpendicular to the plane of the vortex that is greater than the width in the remaining directions.

3. The device of claim 2, wherein the expanded cross-sectional shape of the mesh-like expanded structure is elliptical, the major axis of the ellipse being perpendicular to the plane of swirl and the minor axis of the ellipse being parallel to the plane of swirl.

4. The hemangio-occlusion device of claim 2 or 3, wherein the mesh-like expanded structure comprises a proximal portion, a middle portion, and a distal portion connected axially in sequence; the distal end portion is connected to the positioning guide structure;

5. The device of claim 2 or 3, wherein the cross-sectional area of the expanded mesh-like expanded structure increases and decreases repeatedly from the proximal end to the distal end, or the cross-sectional area of the expanded mesh-like expanded structure increases and decreases sequentially from the proximal end to the distal end.

6. The hemangio-occlusion device of claim 3, wherein the expanded cross-sectional shape of the mesh-like expanded structure is a flattened shape or a non-flattened shape.

7. The device of claim 1, wherein the expanded outer diameters of the positioning guide structures are the same, or the expanded outer diameters of the positioning guide structures are sequentially increased from the distal end to the proximal end and then sequentially decreased.

8. The device of claim 1, wherein the angle between each layer of spirals after expansion of the positioning guide structure and the cross section of the positioning guide structure is between 10 ° and 60 ° so that adjacent layers of spirals of the positioning guide structure are attached.

9. The hemangio-occlusion device of claim 1, wherein the mesh-like expanded structure comprises a proximal portion, a middle portion, and a distal portion connected axially in sequence; the distal end portion is connected to the positioning guide structure; the cross-sectional area of the intermediate portion after expansion is greater than the cross-sectional areas of the proximal and distal portions, and the axial length of the intermediate portion after expansion is no less than 70% of the total length of the mesh expansion structure after expansion.

10. The device of claim 9, wherein the expanded cross-sectional areas of the intermediate portion are the same, the expanded cross-sectional areas of the distal portion increasing in sequence from the distal end to the proximal end, and the expanded cross-sectional areas of the proximal portion increasing in sequence from the proximal end to the distal end.

11. The hemangio-occlusion device of claim 9 or 10, wherein the mesh-like expanded structure is a braided structure braided from braided filaments, the intermediate portion having a braid density that is greater than the braid densities of the proximal and distal portions.

12. The hemangio-occlusion device of claim 11, wherein the number of braided filaments of the proximal portion and the distal portion is half the number of braided filaments of the intermediate portion.

13. The hemangio-occlusion device of claim 1, wherein the number of turns of the helix after expansion of the positioning guide structure is no more than 5.

14. The device of claim 13, wherein the number of turns of the helix after expansion of the positioning guide is 1.5-3.

15. The device of claim 1, wherein the distal end of the positioning guide structure is connected to a length of spring structure.

16. The hemangio-occlusion device of claim 1, wherein a maximum outer diameter of the positioning guide structure after expansion is less than a maximum outer diameter of the mesh expansion structure after expansion.

17. The hemangio-occlusion device of claim 16, wherein a maximum outer diameter of the positioning guide structure after expansion is less than or equal to 1/2 of a maximum outer diameter of the mesh expansion structure after expansion.

18. The hemangio-occlusion device of claim 1, wherein the mesh-like expanded structure has no more than 3 turns of helix after expansion.

19. The device of claim 18, wherein the mesh expansion structure has a number of turns of 1.1 to 1.5 after expansion.

20. The device of claim 1, wherein the expanded cross-sectional shape of the mesh expanded structure is elliptical, the major axis of the ellipse is perpendicular to the plane of the vortex, the minor axis of the ellipse is parallel to the plane of the vortex, and the length of the major axis of the expanded inner spiral of the mesh expanded structure is less than the length of the major axis of the adjacent outer spiral, and the length of the minor axis of the expanded inner spiral of the mesh expanded structure is less than the length of the minor axis of the adjacent outer spiral.

21. The hemangio-occlusion device of claim 20, wherein the mesh-like expanded structure comprises a proximal portion, a middle portion, and a distal portion connected axially in sequence; the distal portion is connected to the positioning guide, and the cross-sectional area of the intermediate portion is greater than the cross-sectional areas of the proximal and distal portions; wherein the major axis length of the oval shape of the intermediate portion is not less than 1/3 of the maximum outer diameter of the expanded mesh-like expanded structure.

22. The hemangio-occlusion device of claim 1, wherein the mesh-like dilating structure and the positioning guide structure are integrally woven and molded.

23. The device of claim 1, wherein at least 1/2 of a turn of the helix is disposed within the central lumen of the planar vortex of the mesh-like expanded structure after expansion of the positioning guide structure.

24. The device of claim 1, wherein the proximal end of the mesh-like dilating structure is fixedly connected to the proximal visualization ring and the distal end of the positioning guiding structure is fixedly connected to the distal visualization ring.

25. The hemangio occlusion device of claim 1, wherein the mesh-like expanded structure is woven from braided wires, the braided wires are of a shape memory material, the braided wires have a diameter of 0.0008-0.002 in, the total number of braided wires is 48-144, the expanded diameter of the mesh-like expanded structure is 2-10 mm, and the maximum outer diameter of the mesh-like expanded structure is 3-25 mm.

26. The hemangio-sealing device of claim 25, wherein the mesh-like expansion structure is braided from developable braided filaments or the mesh-like expansion structure is braided from a mixture of developable braided filaments and non-developable braided filaments.

27. The device of claim 1, wherein the central axis of the expanded positioning guide structure is perpendicular to the plane of the expanded vortex of the mesh-like expanded structure, and wherein the central axis of the expanded mesh-like expanded structure is coincident with or parallel to the central axis of the expanded positioning guide structure.

28. A vascular occlusion treatment device comprising the vascular occlusion device of any of claims 1-27 and a push rod attached to a proximal end of the vascular occlusion device.

29. The device of claim 28, wherein the push rod extends tangentially to a spiral of planar swirl when the mesh expanded structure is in the expanded state.

30. A vascular occlusion system comprising the vascular occlusion device of any of claims 1-27 and a microcatheter, wherein the mesh-like expandable structure and the positioning guide structure are compressed within the microcatheter and are capable of returning to an expanded state of a predetermined shape upon removal from the microcatheter.