CN113855145A

CN113855145A - Hemangioma plugging device, hemangioma plugging treatment device and hemangioma plugging system

Info

Publication number: CN113855145A
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: 2021-12-31
Anticipated expiration: 2041-10-29
Also published as: CN113855145B; 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; location guide structure has three-dimensional spiral helicine expansion state, and hemangioma plugging device expands the back, and location guide structure's partly spiral sets up in the central cavity of plane vortex, and another part spiral is located the outside of plane vortex to fix a position the direction through location guide structure, make the device wholly firm, long-term stable positioning and difficult removal in the tumour, and can realize the packing and stable support to the tumour chamber through netted expansion structure. The invention has the advantages of preventing angioma from breaking and blood vessel from embolism, improving the coverage rate of neck of tumor, promoting the formation of thrombus in tumor, accelerating the embolism of hemangioma and the like while realizing stable stuffing.

Description

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

Technical Field

The invention relates to the technical field of medical instruments, 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, and are the most common cause of non-traumatic subarachnoid hemorrhage (SAH), which, depending on the severity of the hemorrhage, can lead to permanent neurological deficits or death. Currently, there are three main approaches to treating aneurysms: surgical clamping, coil embolization, and blood flow directing devices. The spring ring embolization and blood flow guiding device is used for intravascular interventional therapy, brain tissues can be avoided, lesions can be directly reached, and the characteristics of micro-trauma enable the spring ring embolization and blood flow guiding device to become the mainstream of the current intracranial aneurysm therapy.

Coil embolization is a minimally invasive procedure in which a preformed coil is released from a catheter into the aneurysm sac to fill it, resulting in slow and laminar blood flow within the aneurysm sac. Disruption of blood flow within the aneurysm sac causes clot formation and removal of further blood flow into the structure, thereby preventing further expansion of the aneurysm. When embolization is successful, the thrombus may eventually become covered with a layer of endothelial cells, reforming the inner vessel wall. However, not all coil embolization procedures are successful, which may lead to aneurysm recanalization, and may require the implantation of additional devices, such as auxiliary stents and blood flow guides. The use of multiple devices increases the time of the procedure, the cost of the treatment and the likelihood of adverse events. Meanwhile, spring coil embolization has certain requirements for the skill and experience accumulation of physicians. In recent years, the application of the blood flow guiding device obviously improves the long-term curative effect of large and huge aneurysms, and greatly reduces the use of a spring ring. The computer hemodynamics simulation analysis shows that when the metal coverage rate reaches 30-50%, the blood flow in the aneurysm cavity can be obviously reduced. However, the use of blood flow directing devices has led patients to rely on dual anti-platelet therapy for long periods of time, with the risk of bleeding complications following surgery; while at the same time risking occlusion of the branch vessel with a flow directing device for a bifurcation aneurysm. In addition, there is a certain risk of delayed rupture after treatment of a portion of a large aneurysm.

At present, some novel disposable embolization devices are prepared from shape memory materials, are preformed 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 return to the preformed shape, so that the purpose of plugging aneurysm is achieved. For example, a first embolization device is provided, which is a spherical or cylindrical dense-net device with riveted points at two ends, the whole device is expanded in a tumor cavity, and aneurysm treatment is realized by covering a tumor neck with a near-end dense net. The second embolism instrument is provided, which is a three-dimensional net structure formed by a developing wire and a peripheral self-expanding memory alloy, can be released and recovered through a microcatheter like a spring ring, and can be in a spherical structure when being filled in a tumor, thereby playing a role of turbulence. A third embolic device is also provided, woven from a double layer of nitinol, and operates on a similar principle to the first embolic device, but without a rivet point at the distal end of the device. The fourth embolism instrument is 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, with large contact area but insufficient support, poor long-term stability in the tumor cavity, and easy device displacement. The second embolism apparatus is shaped into a three-dimensional net structure by a plurality of sheet nets, is similar to a sphere, and has the defects of poor forming stability of the apparatus in a tumor, difficult recovery to a preset shape, influence on filling effect, and complex operation because of the large friction force between the three-dimensional net structure and the tumor wall. The third embolic device 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.

Disclosure of Invention

In order to solve the above technical problems, an object of the present invention is to provide a hemangioma occlusion device, a hemangioma occlusion treatment device, and a hemangioma occlusion system, which are used to achieve an occlusion treatment of hemangioma, which can be positioned more stably within the tumor, and which have high embolization efficiency and little damage to the tumor wall.

To achieve the above object, according to a first aspect of the present invention, there is provided a hemangioma occlusion device comprising:

a reticular stent structure having a planar, convoluted, expanded state and a compressed state for intravascular delivery to a hemangioma; and the number of the first and second groups,

a positioning guide structure having a proximal end coupled to the distal end of the mesh-like expandable structure, the positioning guide structure having an expanded state in a three-dimensional helical pattern and a compressed state for delivery from within a blood vessel to a hemangioma;

after the hemangioma occlusion device is configured to expand, one part of the spiral of the positioning and guiding structure is arranged in the central cavity of the planar vortex of the reticular expansion structure, the other part of the spiral is positioned outside the planar vortex of the reticular expansion structure, and the spiral direction of the positioning and guiding structure is the same as the spiral direction of the reticular expansion structure.

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

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

Optionally, the mesh-like expandable structure comprises a proximal portion, an intermediate portion and a distal portion connected axially in series; the distal portion is connected to the positioning guide;

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

Optionally, the area of the cross section of the expanded reticular structure is repeatedly increased and then decreased from the proximal end to the distal end, or the area of the cross section of the expanded reticular structure is sequentially increased and then sequentially decreased from the proximal end to the distal end.

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

Optionally, the expanded outer diameters of the positioning and guiding structures are the same, or the expanded outer diameters of the positioning and guiding structures sequentially increase from the distal end to the proximal end and then sequentially decrease.

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

Optionally, the mesh-like expandable structure comprises a proximal portion, an intermediate portion and a distal portion connected axially in series; the distal portion is connected to the positioning guide; the cross-sectional area of the expanded middle section is greater than the cross-sectional areas of the proximal section and the distal section, and the axial length of the expanded middle section is not less than 70% of the total length of the expanded mesh-like expansion structure.

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

Optionally, the mesh-like expandable structure is a braided structure of braided filaments, the braid density of the intermediate portion being greater than the braid density 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 helical turns after the positioning and guiding structure is expanded is not more than 5.

Optionally, the number of spiral turns of the positioning and guiding structure after expansion is 1.5-3.

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

Optionally, the expanded maximum outer diameter of the positioning and guiding structure is smaller than the expanded maximum outer diameter of the mesh-like expanding structure.

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

Optionally, the mesh-like expandable structure has no more than 3 helical turns after expansion.

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

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

Optionally, the mesh-like expandable structure comprises a proximal portion, an intermediate portion and a distal portion connected axially in series; the distal portion is connected to the positioning guide, and the intermediate portion has a cross-sectional area greater than the cross-sectional areas of the proximal portion and the distal portion; wherein the major axis length of the ellipse of the intermediate portion is not less than 1/3 of the maximum outer diameter of the expanded mesh-like expandable structure.

Optionally, the mesh-like expanding structure and the positioning and guiding structure are integrally woven and formed.

Optionally, at least 1/2 spirals are disposed within the central lumen of the planar vortex of the mesh-like expansion structure after expansion of the positioning guide structure.

Optionally, the distal end of the mesh-like expandable structure is fixedly connected to the distal developer ring, and/or the proximal end of the mesh-like expandable structure is fixedly connected to the proximal developer ring.

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

Optionally, the mesh-like expansion structure is woven by developable weaving wires, or the mesh-like expansion structure is woven by mixing developable weaving wires and non-developable weaving wires.

Optionally, the central axis of the expanded positioning and guiding structure is perpendicular to the vortex plane of the expanded mesh-shaped expanding structure, and the central axis of the expanded mesh-shaped expanding structure coincides with or is parallel to the central axis of the expanded positioning and guiding structure.

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

Optionally, the push rod extends in a tangential direction of a spiral of the planar vortex when the mesh-like expansion structure is in the expanded state.

In order to achieve the above object, according to a third 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 mesh-like expansion structure and the positioning and guiding structure are compressed in the microcatheter and are capable of returning to an expanded state of a predetermined shape after being detached from the microcatheter.

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

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

the hemangioma occlusion device is placed in the hemangioma, a positioning guide structure is firstly released in the hemangioma, the positioning guide structure is rotationally molded in the hemangioma and is restored to a three-dimensional spiral shape, then the reticular expansion structure is further pushed to be released, the reticular expansion structure is continuously rotationally molded by taking the positioning guide structure as a central shaft until the reticular expansion structure is completely expanded to a plane vortex shape, and a central cavity of a plane vortex of the reticular expansion structure wraps a part of spiral of the positioning guide structure.

Optionally, the method further comprises:

when the reticular dilation structure is completely unfolded in the hemangioma, the proximal end of the reticular dilation structure is parallel to the tumor wall of the hemangioma and does not herniate into the blood vessel.

Optionally, the method further comprises:

when the reticular dilation structure is released in the hemangioma, the reticular dilation structure is enabled to be stuffed both on a stuffing plane of the tumor cavity and in a direction perpendicular to the stuffing plane. The packing mode can enlarge the packing height to adapt to the condition that the tumor cavity is larger in size.

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 a plane vortex and a three-dimensional spiral, and the three-dimensional spiral can play a role of a central shaft, so that the device is more stable in the releasing process and is not easy to turn over, the influence of the device on the aneurysm is reduced, and the bleeding risk caused by rupture is reduced. And the plane vortex structure has no orientation, the friction force between the inner layer and the outer layer is large, the tumor neck coverage rate is high, and meanwhile, the device is more stable and is not easy to shift. Meanwhile, the multi-layer spiral composite structure enables intratumoral molding to be more stable, and the multi-layer dense net structure can improve embolism density and reduce the number of instruments required by the operation. In addition, the hemangioma plugging device provided by the invention is completely positioned in the aneurysm, so that the use of dual antiplatelet drugs can be avoided, the device can improve the coverage of the neck of the aneurysm, simultaneously increase the internal turbulence effect, promote the formation of thrombus in the aneurysm, accelerate the embolization of the aneurysm, and has high embolization effect and high embolization efficiency. In addition, the hemangioma plugging device provided by the invention is simple to release, can reduce the dependence on the personal aneurysm embolization experience of a doctor in the operation process, and can reduce the operation time.

The expanded cross section of the reticular expansion structure in the hemangioma occlusion device provided by the invention has a width in the direction vertical to the vortex plane larger than the width in other directions, for example, the reticular expansion structure is in an oval shape after being expanded, the long axis of the reticular expansion structure is vertical to the vortex plane, and the short axis of the reticular expansion structure is parallel to the vortex plane.

Drawings

FIG. 1 is a top view of a preferred embodiment of the expanded structure of a hemangioma occlusion device of the present invention, wherein the positioning and guiding structure comprises 1.5 spirals and the mesh-like expanded structure comprises 1.5 spirals;

FIG. 2 is an elevational view of a preferred embodiment of the aneurysm occlusion device of the invention after expansion, wherein the placement guide comprises 1.5 spirals and the mesh-like expansion structure comprises 1.5 spirals;

FIG. 3 is a schematic view of a preferred embodiment of the present invention showing a state of endovascular delivery of a aneurysm occlusion device via a microcatheter, wherein a positioning guide structure and a mesh-like expandable structure are compressed into a linear configuration within the microcatheter; the whole shape of the linear structure is just like a long chain, the reticular expansion structure recovers a plane vortex in the expansion state of the structure, the positioning guide structure recovers a three-dimensional spiral shape, and the whole device can be in a linear shape when being stretched;

FIG. 4 is a view of a preferred embodiment of the aneurysm occlusion device of the present invention in an incompletely released state within the aneurysm, wherein the placement guide structure is completely released within the aneurysm and a portion of the mesh-like expandable structure is rotated around the three-dimensional helical structure;

FIG. 5 is a view of a preferred embodiment of the present invention showing a aneurysm occlusion device fully released within a aneurysm, wherein a portion of the positioning guide structure is disposed within the central lumen of the planar vortex structure and the remainder of the positioning guide structure is disposed outside the planar vortex structure;

FIG. 6 is a view showing the state that the outer dense net of the net-like expanding structure of the hemangioma occlusion device covers the neck of the tumor;

FIG. 7 is a top view of an expanded structure of a hemangioma occluding device of another preferred embodiment of the invention, wherein the positioning and guiding structure comprises 2 spirals and the mesh-like expanded structure comprises 1 spiral;

figure 8 is a top view of an expanded structure of a hemangio-occlusion device of another preferred embodiment of the present invention, wherein the placement guide comprises 2 spirals and the mesh-like expansion structure comprises 2 spirals.

The reference numerals are explained below:

10-a hemangioma occlusion device; 11-a reticulated expanding structure; 111-the proximal end of the reticulated dilation structure; 112-the distal end of the mesh-like expansion structure; 110-the outer dense mesh side of the expanded mesh structure; 113-a proximal portion; 114-a middle portion; 115-a distal portion;

12-positioning the guide structure;

20-a push rod;

30-an aneurysm; 31-tumor neck and mouth;

40-a microcatheter;

d1-maximum outer diameter of expanded reticulated stent structure; d2-maximum outer diameter of the positioning guide structure after expansion; d-the expanded diameter of the intermediate section; a-major axis of ellipse; b-elliptical minor axis; p-vortex plane; alpha-helix down angle.

Detailed Description

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming 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. The term "plurality" is generally employed in a sense that it includes two or more, unless the content clearly dictates otherwise. The term "plurality" is generally employed in a sense including an indefinite amount unless the content clearly dictates otherwise. The term "proximal" generally refers to the end near the operator of the instrument; "distal" is the end opposite the "proximal" and "distal" generally refers to the end of the instrument that enters the body first, unless the context clearly dictates otherwise. Herein, the "maximum outer diameter of the expanded mesh structure" means the maximum diameter on a projection plane perpendicular to the central axis of the planar vortex after the expanded mesh structure; the maximum outer diameter of the positioning and guiding structure refers to the maximum diameter of the positioning and guiding structure on a projection plane perpendicular to the central axis of the three-dimensional spiral.

Fig. 1 is a top view of a preferred embodiment of the aneurysm occlusion device 10 of the present invention after expansion, and fig. 2 is a front view of a preferred embodiment of the aneurysm occlusion device 10 of the present invention after expansion.

As shown in fig. 1 and 2, the present embodiment provides a aneurysm occlusion device 10 for effecting occlusion treatment of a aneurysm, including but not limited to an intracranial aneurysm, which may be a bifurcation aneurysm or a side wall aneurysm. In practical application, the hemangioma plugging device 10 is wholly arranged in the hemangioma, the near end of the hemangioma plugging device can not enter a parent artery, double antiplatelet drugs do not need to be taken for a long time, simultaneously, the embolization efficiency is high, the requirements on skills and experience of doctors can be reduced, and the hemangioma plugging device does not need to be matched with other instruments for use, so that the risk of generating ischemic complications is reduced, and the operation time is reduced.

In the following description, the treatment of a side-wall aneurysm is mainly taken as an illustration to show that the aneurysm occlusion device 10 is easy to perform the occlusion treatment of the aneurysm, but those skilled in the art will know that the aneurysm occlusion device 10 can also be applied to the occlusion treatment of other hemangiomas.

The hemangioma occlusion device 10 specifically comprises a reticular expansion structure 11 and a positioning guide structure 12. The reticulated expansile structure 11 has a planar, convoluted, expanded state and a compressed state for intravascular delivery to a hemangioma; the positioning guide structure 12 has an expanded state in a three-dimensional helical pattern and a compressed state for delivery from within the blood vessel to the aneurysm; the spiral direction of the expanded three-dimensional spiral of the positioning guide structure 12 is the same as the spiral direction of the expanded planar vortex of the reticular expansion structure 11. The spiral direction here only means the counterclockwise direction or the clockwise direction, and does not limit the change in the three-dimensional direction of the space; and the spiral direction is the same for location guide structure 12 can effectively drive netted expanding structure 11 and arrange at tumor intracavity spiral, makes netted expanding structure 11 can evenly follow tumor wall shape and arranges, and avoids netted expanding structure 11 to take place extrusion deformation because of rubbing the tumor wall, and then leads to the incomplete problem of tumor neck cover.

In addition, the central axis of the expansion of the positioning and guiding structure 12 and the vortex plane after the expansion of the mesh-like expansion structure 11 may be perpendicular or not. The expanded central axis of the mesh-like expanding structure 11 and the expanded central axis of the positioning and guiding structure 12 may or may not coincide and may or may not be parallel. That is, it is sufficient to ensure that a portion of the three-dimensional spiral structure after expansion of the pilot structure 12 is not in the same plane as the planar vortex. In one embodiment, the expanded central axis of the positioning and guiding structure 12 is perpendicular to the plane of the vortex of the expanded mesh-like expanding structure 11, and the expanded central axis of the mesh-like expanding structure 11 is coincident with or parallel to the expanded central axis of the positioning and guiding structure 12. The proximal end of the positioning guide structure 12 is connected to the distal end of the mesh-like expanding structure 11, and preferably, both are integrally formed by weaving. It should be understood that the entire positioning guide structure 12 is disposed outside the distal end of the mesh-like expansion structure 11, that is, the positioning guide structure 12 is not disposed in a portion of the mesh body of the mesh-like expansion structure 11, and that a portion of the positioning guide structure 12, which is described below, is spirally disposed in the central cavity of the planar vortex of the mesh-like expansion structure 11 means that the mesh body of the mesh-like expansion structure 11 wraps a portion of the positioning guide structure 12 during the formation of the planar vortex, but does not mean that the portion of the positioning guide structure 12 is disposed in the mesh body of the mesh-like expansion structure 11.

After the hemangioma occlusion device 10 is expanded, a part of the spiral of the positioning guide structure 12 is arranged in the central cavity of the planar vortex of the reticular expansion structure 11, and the other part of the spiral of the positioning guide structure 12 is arranged outside the planar vortex of the reticular expansion structure 11, so that the positioning guide structure 12 is used for positioning and guiding, and the reticular expansion structure 11 is used for supporting, filling the tumor cavity and occluding the tumor neck. More specifically, location guide structure 12 can make whole device whole firm, can be in the tumour long-term stable positioning and difficult removal, and the dense net face in the outside of netted expansion structure 11 distributes along tumour chamber profile when covering the tumour neck, makes to pack and supports and realizes simultaneously, and the embolism is effectual, and the embolism is efficient.

In more detail, the hemangioma plugging device 10 can provide a continuous covering surface with high metal coverage rate and high mesh density at the neck of a tumor through the dense mesh of the mesh-shaped expansion structure 11, and has good plugging effect; meanwhile, the composite structure of the plane vortex and the three-dimensional spiral can reduce the influence of the far end and the near end of the device on the coverage of the aneurysm wall and the aneurysm neck, namely, the far end and the near end can not damage the aneurysm wall, the near end can not hernia into the parent artery, and a dense net which is distributed in a plurality of circles inside and outside the aneurysm cavity is formed in the aneurysm cavity, so that the space division of the aneurysm cavity is increased, and the embolization efficiency is improved. Therefore, the hemangioma plugging device 10 of the invention can improve the covering rate of the neck of the aneurysm, simultaneously improve the turbulence effect inside the aneurysm, promote the formation of thrombus in the aneurysm and accelerate the embolism of the aneurysm. It should be understood that in the initial release stage in the hemangioma, the smaller diameter of the three-dimensional spiral structure can play a guiding role, and as the device is further released, the three-dimensional spiral structure plays a role of a central shaft, the device is positioned, so that the device cannot turn over in the aneurysm cavity, and is stably filled, and then the planar vortex structure rotates along the central shaft constructed by the three-dimensional spiral structure to form a state of being filled along the contour of the aneurysm cavity, so that the device can be stably molded. In addition, the far end and the near end of the whole device are soft, and the far end and the near end are not in contact with the tumor wall, so that the tumor wall cannot be impacted, and the tumor wall is slightly damaged. After the release is finished, the outer side dense mesh surface of the planar vortex structure contacts with the tumor wall, the tumor neck opening is of a continuous dense mesh structure, the coverage rate of the tumor neck opening is high, the blocking effect is good, the stress is dispersed and is not easy to shift, and the stable blocking can be realized.

The hemangioma occluding device 10 of the present invention is an instrument for vascular interventional therapy, and is delivered in vivo through a microcatheter 40. To this end, the present invention further provides a system for closing off a hemangioma, comprising a device 10 for closing off a hemangioma and a micro-catheter 40 (see fig. 3 and 4), wherein the mesh-like expandable structure 11 and the positioning and guiding structure 12 are compressed in the micro-catheter 40 and are capable of returning 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 inches, 0.021 inches, or 0.027 inches. Meanwhile, the invention also provides a hemangioma occlusion treatment device, which comprises a hemangioma occlusion device 10 and a push rod 20, wherein the push rod 20 is connected to the proximal end of the hemangioma occlusion device.

The detailed operation of the aneurysm occlusion device 10 can be seen in fig. 3 to 6:

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

as shown in fig. 4, after the distal end of the microcatheter 40 is positioned at the aneurysm 30, the pushing rod 20 is used to push the aneurysm occlusion device 10 to the distal end of the microcatheter 40, so that the positioning guide structure 12 is firstly released and formed in the aneurysm 30, and then the pushing of the aneurysm occlusion device 10 is continued, so that the reticular dilation structure 11 is further rotationally formed on the basis of the positioning guide structure 12;

finally, as shown in fig. 5, the net-like expansion structure 11 is distributed along the contour of the aneurysm cavity to form a planar vortex and fill the whole aneurysm 30, and a part of the spiral of the positioning guide structure 12 is wrapped by the planar vortex while the outer dense net surface 110 of the net-like expansion structure 11 covers the neck opening 31, as shown in fig. 6;

after the hemangioma plugging device 10 is completely released, the microcatheter 40 and the push rod 20 are removed; wherein figure 5 shows the state of the aneurysm occlusion device 10 remaining within the aneurysm 30 after the microcatheter 40 and push rod 20 have been withdrawn.

The proximal end 111 of the mesh-like stent 11 is actually releasably coupled to the push rod 20. The push rod 20 preferably extends along the tangential direction of the spiral line of the planar vortex when the mesh-like expansion structure 11 is in the expanded state, so that when the push is released, the outer dense mesh surface 110 of the maximum outer diameter D1 of the mesh-like expansion structure 11 covers the tumor neck opening 31, that is, the outer dense mesh surface 110 of the mesh-like expansion structure 11 is disposed across the neck of the aneurysm 30, thereby improving the coverage rate of the tumor neck opening 31, preventing the proximal end 111 of the aneurysm occlusion device 10 from herniating, and simultaneously ensuring that the proximal end 111 of the aneurysm occlusion device 10 is not located in the middle of the tumor neck opening 31 to avoid affecting the healing of the tumor neck. The releasing manner between the pushing rod 20 and the mesh-like expanding structure 11 can be thermal releasing, electrical releasing, mechanical releasing or hydrolytic releasing, etc. in the prior art, which is not limited in this respect. The pushing rod 20 is used for pushing the hemangioma plugging device 10 to be separated from the micro-catheter 40, so that the release of the hemangioma plugging device 10 in the aneurysm 30 is realized.

The mesh-like expansion structure 11 is a woven mesh body woven by woven filaments and is pre-shaped into a planar vortex structure. The positioning and guiding structure 12 is preferably woven and pre-shaped into a three-dimensional spiral structure, and the mesh tube can be woven by weaving wires firstly, and then is pre-shaped into a three-dimensional spiral structure after being stretched into a slender shape. In this embodiment, the mesh-like expanding structure 11 and the positioning guide structure 12 are integrally woven and respectively shaped as a planar vortex and a three-dimensional spiral. The positioning guide 12 may serve, in use, as a central axis of the planar scroll within the central cavity of which is disposed the partial spiral of the positioning guide 12, i.e., the planar scroll is in the same plane as the most proximal partial spiral of the three-dimensional spiral, preferably at least 1/2 spiral turns of the positioning guide 12 are disposed within the central cavity of the planar scroll after expansion. Figure 2 shows that 1 turn of the spiral is disposed within the central cavity of the planar scroll structure after expansion of the pilot structure 12.

The expanded cross-sectional area of the expanded mesh-like structure 11 preferably increases and then decreases sequentially from the proximal end 111 to the distal end 112, or the expanded cross-sectional area of the expanded mesh-like structure 11 increases and then decreases repeatedly from the proximal end to the distal end, i.e., the repeated increases and decreases. In this embodiment, the expanded sac-like expanded structure 11 is configured as a fusiform structure, i.e., the sac-like expanded structure 11 has two small ends and a large middle. The reticular expansion structure 11 with the changed cross section can increase the flexibility of the device, reduce the pushing resistance, reduce the impact on the tumor wall, facilitate the compression and reduce the compression size.

Referring to fig. 1, in some embodiments, the mesh-like expandable structure 11 includes a proximal portion 113, an intermediate portion 114, and a distal portion 115 connected in axial sequence, the distal portion 115 being connected to the positioning guide structure 12. Wherein the expanded cross-sectional area of the intermediate portion 114 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 from the distal end 112 to the proximal end 111, the cross-sectional area (or diameter) of the proximal portion 113 increases from the proximal end 111 to the distal end 1112, and the cross-sectional areas of the intermediate portions 114 are the same. Because the woven mesh tube of the positioning and guiding structure 12 is small in size, and the woven mesh tube of the middle part 114 is large in size, in order to enable the middle part 114 and the positioning and guiding structure 12 to be smoothly transited, the distal part 115 with the gradually-increased cross section is used for smoothly transitionally connecting the positioning and guiding structure 12, smooth transition between a planar vortex structure and a three-dimensional spiral structure is ensured, and the proximal part 113 and the distal part 114 with the changed cross section can increase the flexibility of the whole device and reduce damage to the tumor wall.

The braided wire ends at the nearest end of the mesh-like expansion structure 11 can be gathered into a bundle and welded or fixed by a near-end sleeve, preferably fixed by the near-end sleeve, so that the damage to the tumor wall caused by the exposed wire ends is avoided. 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 113 and distal 115 sections should not be too long, which would increase the resistance to advancement of the entire device, as well as increase the length of the ineffective 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 neck of the tumor without packing, so that proximal portion 113 and distal portion 115 are effectively void-filled segments, both of which, if too long, can affect the length of the tumor-filled cavity of the overall device, and also can reduce pushability. For this reason, the expanded axial length of the intermediate portion 114 is preferably not less than 70% of the expanded axial total length of the expanded mesh-like expandable structure 11. In some embodiments, the expanded axial length of the intermediate portion 114 is 70% of the expanded axial total length of the expanded mesh-like expandable structure 11. In some embodiments, the expanded axial length of the intermediate portion 114 is 80% of the total expanded axial length of the entire mesh structure 11. In some embodiments, the expanded axial length of the intermediate portion 114 is 90% of the expanded axial total length of the expanded mesh-like expandable structure 11.

When the hemangioma occlusion device 10 is completely expanded, the proximal part 113 of the reticular expansion structure 11 is tightly attached to the middle part 114, and the middle part 114 is tightly attached to the distal part 115, i.e. the inner layer and the outer layer of the planar vortex structure are tightly attached in a spiral manner, so that a dense net structure which is tightly arranged inside and outside is formed, and the embolization effect is ensured. In order to control the size of the planar vortex conveniently, in actual manufacturing, it is preferable that each adjacent spiral of the planar vortex-shaped reticular structure 11 is tightly screwed together, for example, the outer wall of the first spiral is fitted with the inner wall of the second spiral, and the outer wall of the second spiral is fitted with the inner wall of the third spiral, which is suitable for the case of more spirals, so as to facilitate better molding of the reticular structure 11 under the guidance of the positioning guide structure 12. It should be understood that the first spiral of the reticular dilation structure 11 refers to the first spiral wound from the most distal end of the reticular dilation structure 11.

The cross-sectional shape of the expanded reticulated expanded structure 11 may be various shapes, such as a regular shape, e.g., a circle, an ellipse, etc., or a deformed shape, and more preferably, the expanded cross-sectional shape of the reticulated expanded structure 11 has a width in a direction perpendicular to the vortex plane larger than the width in the remaining direction. Further, the expanded cross-section of the middle portion 114 has a width in the direction perpendicular to the vortex plane larger than the width in the other directions, so as to increase the height of the tumor-filled cavity of the expanded mesh-like expanded structure 11, thereby filling the tumor cavity with a larger size.

In some embodiments, as shown in FIG. 2, the expanded cross-sectional shape of the expanded mesh-like expansion structure 11 is an ellipse, with the major axis A of the ellipse being perpendicular to the vortex plane P and the minor axis B being parallel to the vortex plane P. The cross-sectional area of the middle portion 114 remains constant, i.e., the middle portion 114 is a braided mesh tube of equal diameter. Oval-shaped mid portion 114 can also increase the frictional force between the inner and outer circles of the planar vortex structure in addition to increasing the packing height, so that the whole hemangioma plugging device 10 is more stable after packing the aneurysm, and the displacement between the inner and outer circles of the planar vortex structure is avoided, thereby making the whole hemangioma plugging device more stable.

While the expanded cross-sectional area of the proximal portion 113 increases from the proximal end to the distal end, in some embodiments, the proximal portion 113 may be conically shaped after expansion, as shown in FIG. 1, while in other embodiments, the proximal portion 113 may have an expanded half-ellipsoidal configuration, as shown in FIG. 7.

Further, the expanded cross-sectional shape of the expanded mesh-like expanding structure 11 may be a flat shape or a non-flat shape. In some embodiments, the expanded cross-sectional shape of the expanded mesh-like stent structure 11 is an ellipse, wherein the ratio of the length of the major axis A to the length of the minor axis B of the ellipse is not very different, so as 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 very different, so as to form a flattened ellipse, i.e., the major axis A is increased and the minor axis B is decreased compared to the ellipse shown in FIG. 2, as shown in FIG. 8.

The expanded outer diameter of the positioning and guiding structure 12 may be the same or sequentially increases from the distal end to the proximal end, or the expanded outer diameter of the positioning and guiding structure 12 sequentially increases from the distal end to the proximal end and then sequentially decreases, preferably, the expanded maximum outer diameter D2 of the positioning and guiding structure 12 is smaller than the expanded maximum outer diameter D1 of the mesh-like expanded structure 11. In this embodiment, the expanded outer diameters of the positioning and guiding structures 12 are the same, so as to reduce the manufacturing difficulty. The positioning and guiding structure 12 is slender and flexible, the outer diameter of each layer of spiral is preferably the same, the central axis of the whole hemangioma plugging device 10 is formed by a plurality of layers of three-dimensional spiral structures, and the farthest end of the positioning and guiding structure 12 can be fixed by a far-end developing ring, so that the far end of the whole hemangioma plugging device can be developed. Further preferably, after the positioning and guiding structure 12 is expanded, the downward angle α of each layer of helix is 10 ° to 60 °, such as 15 °, 20 °, 30 °, and the like, so as to reduce the gap between adjacent helices, so that adjacent helices can be tightly attached, and the support performance is better. It should be understood that, in the early stage of the aneurysm filling process, since the maximum outer diameter D2 of the positioning and guiding structure 12 is far smaller than the diameter of the aneurysm, the friction force between the positioning and guiding structure and the aneurysm wall is small, and the guiding function can be achieved; with further packing, the central axis is progressively acted upon, and the outer planar vortex structure can be rotationally released along the central axis, eventually creating a packed state along the contour of the tumor cavity. After the filling is finished, the positioning guide structure 12 plays a role of a central shaft to position the filling position; the outer dense mesh surface of the external planar vortex structure is distributed along the tumor cavity and covers the tumor neck, and the fusiform or oval shape of the proximal part 113 is compressed between the mesh body of the middle part 114 and the tumor wall, so that the hernia cannot occur to the parent artery, and the tumor wall cannot be damaged.

Preferably, the distal end of the positioning and guiding structure 12 is connected with a section of spring structure, the spring structure may be a spiral shape, the outer diameter of the spring structure is not greater than the maximum outer diameter of the positioning and guiding structure 12, and the number of spiral turns is not greater than the number of spiral turns of the positioning and guiding structure 12. So configured, the flexibility of the device during initial release can be further reduced,

the reticular dilation structure 11 is formed by weaving and shaping fine wires, the number of the weaving wires is preferably 48-144, the wire diameter of the weaving wires can be 0.0008-0.002 in, and therefore a dense net with high grid density can be constructed, blood flow in a tumor cavity is effectively blocked, thrombus formation in the tumor is promoted, and the coverage rate of tumor necks is improved. Further, the diameter D of the middle portion 114 may be selected to be 2mm to 10mm, and the maximum outer diameter D1 of the expanded reticular dilatation structure 11 is 3mm to 20 mm. Diameter D here refers to the size of the cross-section of the intermediate portion 114. Further, the braid density of the intermediate portion 114 is greater than the braid density of the proximal portion 113 and the distal portion 115 to increase the flexibility of the overall device, reduce damage to the aneurysm wall, and avoid bleeding from the ruptured aneurysm. The number of braided wires of the proximal and

distal portions

113, 115 may be reduced to a minimum of half the number of braided wires of the intermediate portion 114, so that the distal and proximal ends of the aneurysm occlusion device may be more flexible. The braided wire ends at the proximal 111 and distal 112 ends of the mesh stent 11 may be welded or embedded in a sleeve.

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

The number of helical turns of the expanded mesh stent 11 is preferably no more than 3 to avoid increasing the axial length of the entire device, which would increase the size of the delivery device. More preferably, the number of turns of the expanded mesh-like expanded structure 11 is 1.1 to 1.5 turns. In the aneurysm, the outer side wall of the inner spiral is connected with the inner side wall of the outer spiral after the reticular expansion structure 11 is expanded, and the outer spiral and the inner side wall rotate in sequence. In some embodiments, the cross-sectional shape of the reticulated dilation structure 11 is elliptical, and particularly for the intermediate portion 114, it is preferred that the length of the major axis of the ellipse of the inner helix is less than the length of the major axis of the outer helix adjacent thereto, and the length of the minor axis of the inner helix is less than the length of the minor axis of the outer helix adjacent thereto, such that the cross-sectional dimension of the largest helix is larger to enable adequate packing of the tumor lumen. Optionally, the expanded maximum outer diameter D1 of the expanded mesh-like expanding structure 11 is 3-25 mm, wherein the length of the major axis a of the ellipse of the middle portion 114 is not less than 1/3 of the maximum outer diameter D1 of the expanded mesh-like expanding structure 11.

As previously mentioned, the reticulated expanding structure 11 has a compressed state and an expanded state. When the reticulated dilation structure 11 is in an expanded state, the reticulated dilation structure 11 has a planar vortex shape; when the expanded mesh structure 11 is in a compressed state, it is convenient to deliver the expanded mesh structure 11 intravascularly to the aneurysm via the microcatheter 40. More specifically, when the expanded mesh structure 11 is loaded within the microcatheter 40, it has a compressed state, in which the expanded mesh structure 11 is generally linear in shape to minimize its radial dimension for ease of delivery; when the expanded mesh structure 11 is detached from the microcatheter 40, it is elastically expanded by itself to have a flat spiral expanded state. Similarly, the positioning guide structure 12 also has a compressed state and an expanded state. When the positioning and guiding structure 12 is in the expanded state, the positioning and guiding structure 12 is restored to the three-dimensional spiral shape as a whole; when the positioning guide structure 12 is in a compressed state, it is also convenient to deliver the positioning guide structure 12 intravascularly to the hemangioma through the microcatheter 40. In more detail, when the positioning guide structure 12 has a compressed state inside the microcatheter 40, the positioning guide structure 12 is linear in shape and has a small radial dimension; when the positioning and guiding structure 12 is separated from the micro-catheter 40, it is expanded by its own elasticity to have an expanded state, and in the expanded state, the positioning and guiding structure 12 is entirely restored to a three-dimensional spiral shape.

In an exemplary embodiment, as shown in FIGS. 1 and 2, the positioning guide structure 12 comprises 1.5 spirals after expansion, the downward angle α of the spiral being 30. It will be appreciated that the helix has a downward angle a which is the angle between the helix and the cross-section of the positioning guide structure 12. In some embodiments, as shown in fig. 1 and 2, the expanded mesh dilation structure 11 comprises 1.5 helical turns and the expanded axial length of the intermediate portion 114 is 70% of the total expanded length of the mesh dilation structure 11. Fig. 1 and 2 also show that the positioning guide structure 12 and the intermediate portion 114 are smoothly transitionally connected by a distal portion 115 with a sequentially changing cross-section, and that the proximal portion 113 is fusiform and has a relatively short length, and that the sum of the axial lengths of the proximal portion 113 and the distal portion 115 after expansion accounts for 30% of the total length of the expanded mesh-like expanded structure 11 after expansion. It is also shown in fig. 1 and 2 that the expanded maximum outer diameter D2 of the positioning guide structure 12 is 1/3 of the expanded maximum outer diameter D1 of the expanded mesh-like expandable structure 11, and the expanded cross-sectional shape of the intermediate portion 114 is elliptical and the length of the major axis a is 1/2 of the maximum outer diameter D1 of the mesh-like expandable structure 11.

In another exemplary embodiment, as shown in FIG. 7, the positioning guide structure 12 comprises 2 spirals having a down-run angle α of 20 ° when expanded, and the expanded mesh expansion structure 11 comprises 1 spiral, and the expanded axial length of the intermediate portion 114 is 80% of the total length of the expanded mesh expansion structure 11. Fig. 7 also shows that the positioning guide 12 and the intermediate section 114 are smoothly transitioned from the distal section 115 with sequentially changing cross-sections, but the proximal section 113 is ellipsoidal and the sum of the axial lengths of the expanded proximal section 113 and the distal section 115 accounts for 20% of the total length of the expanded mesh-like expanded structure 11. FIG. 7 also shows that the expanded maximum outer diameter D2 of the positioning guide structure 12 is 2/5 of the expanded maximum outer diameter D1 of the expanded mesh-like expandable structure 11, and the expanded cross-sectional shape of the intermediate portion 114 is elliptical, with the major axis A being 3/7 of the maximum outer diameter D1 of the mesh-like expandable structure 11.

In yet another exemplary embodiment, as shown in FIG. 8, the positioning guide structure 12 comprises 2 spirals after expansion, the descending angle α is 15 °, and the expanded mesh-like expansion structure 11 comprises 2 spirals after expansion, wherein the mesh-like expansion structure 11 comprises a fusiform distal portion 115, a flat medial portion 114, and a fusiform proximal portion 113, and the flat medial portion 114 occupies 90% of the total expanded length of the mesh-like expansion structure 11 after expansion. 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 expansion structure 11, and the long axis length of the expanded middle portion 114 of the flat is 2/3 of the maximum outer diameter of the expanded mesh-like expansion structure 11.

Preferably, the material of the braided wire of the mesh-like expansion 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 (Ni-Ti-Co) alloy, 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 object has the functions of memorizing and recovering the original shape. Preferably, the mesh-like expanding structure 11 is woven by using a developable weaving yarn, or the mesh-like expanding structure 11 is woven by mixing a developable weaving yarn and a non-developable weaving yarn. By adopting the design, the reticular expansion structure 11 can be developed under X-rays, the elasticity of the reticular expansion structure 11 is ensured, and the reticular expansion 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 in the present invention, and platinum (Pt), platinum-iridium (Pt-Ir), Au (gold), or the like can be used, for example. In some embodiments, the braided wire is a composite structure including a sheath and a core wire, the sheath covers the core wire, the core wire is made of a material including but not limited to one or more of radiopaque materials such as platinum, iridium, gold, silver, tantalum, and tungsten, the sheath has no developability, and the sheath is made of a material including but not limited to one or more combinations of nitinol, stainless steel, cobalt-chromium alloy, and nickel-cobalt alloy. Preferably, the braided wires of the intermediate portion 114 are developable, the braided wires of the proximal portion 113 and the distal portion 115 are not developable, and the developing material is used as the braided wires of the intermediate portion 114, so that the X-ray developability of the mesh-like expanding structure 11 is better, and the safety and accuracy of the surgical operation are improved.

Further, the present invention also provides a method for treating a hemangioma, wherein the neck of the hemangioma leads to a blood vessel, the method comprising:

the hemangioma plugging device 10 is placed in a hemangioma, a positioning guide structure is released in the hemangioma firstly, the positioning guide structure is rotationally molded in the hemangioma and is restored to a three-dimensional spiral shape, then a reticular expansion structure is further pushed to start releasing the reticular expansion structure, the reticular expansion structure is continuously rotationally molded by taking the positioning guide structure as a central shaft until the reticular expansion structure is completely expanded to be in a planar vortex shape, and a central cavity of a planar vortex of the reticular expansion structure wraps a part of a spiral of the positioning guide structure.

Optionally, the method further comprises:

when the reticular dilation structure is released in the hemangioma, the reticular dilation structure is enabled to be stuffed both on the stuffing plane of the tumor cavity and in the direction perpendicular to the stuffing plane, such as configuring the reticular dilation structure, particularly the middle part, into an ellipse, the long axis of the ellipse is perpendicular to the stuffing plane, and the short axis of the ellipse is parallel to the stuffing 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 and guiding structure at the far end so as to realize stable filling, and 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 tumor cavity outline, so that the device can be stably formed, is stable in forming and good in filling effect, and meanwhile, the far end and the near end of the device cannot impact the tumor wall and have small damage to the tumor wall, and the outer side surface of the external plane vortex structure contacts the tumor wall, so that the device is a continuous net-tight structure, has high tumor neck coverage rate, realizes stable support due to dispersed stress and is not easy to shift. In addition, the cross section area of the proximal part of the reticular expansion structure is increased from the proximal end to the distal end, the structure is convenient to compress and is attached to the outer side wall of the largest spiral of the planar vortex structure, and the impact on the tumor wall is reduced while the stability of the device in the tumor cavity is maintained. And because the internal three-dimensional spiral structure exists, the friction force between the inner vortex and the outer vortex is increased, the whole device is more stable and is not easy to shift and deform, and the risk of proximal hernia is reduced. In addition, hemangioma plugging device can provide continuous dense net covering surface at the neck of tumour, can improve and provide the scaffold for follow-up endothelialization of tumour neck mouth when reducing blood and flowing into aneurysm, especially inside be multilayer dense net structure, has increased the blood flow resistance in the tumour chamber, can be faster promote thrombosis, further improves the embolism efficiency of aneurysm, and then promotes the shutoff treatment of aneurysm.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the present invention.

Claims

1. A hemangioma occlusion device, comprising:

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

3. The hemangioma occlusion device of claim 2, wherein the expanded cross-sectional shape of the mesh-like expanded structure is an ellipse with the major axis perpendicular to the vortex plane and the minor axis parallel to the vortex plane.

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

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

7. The hemangioma occlusion device of claim 1, wherein the expanded outer diameters of the positioning and guiding structures are the same, or the expanded outer diameters of the positioning and guiding structures increase sequentially from the distal end to the proximal end and then decrease sequentially.

8. The hemangioma occlusion device of claim 1, wherein the angle between each layer of spiral after the positioning and guiding structure is expanded and the cross section of the positioning and guiding structure is 10-60 degrees, so that adjacent layers of spiral of the positioning and guiding structure are attached to each other.

9. The hemangioma occlusion device of claim 1, wherein the mesh-like expandable structure comprises a proximal portion, an intermediate portion, and a distal portion connected axially in series; the distal portion is connected to the positioning guide; the cross-sectional area of the expanded middle section is greater than the cross-sectional areas of the proximal section and the distal section, and the axial length of the expanded middle section is not less than 70% of the total length of the expanded mesh-like expansion structure.

10. The aneurysm occlusion 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 increase sequentially from the distal end to the proximal end, and the expanded cross-sectional areas of the proximal portion increase sequentially from the proximal end to the distal end.

11. The hemangioma occlusion device of claim 9 or 10, wherein the mesh-like expansion structure is a braided structure of braided filaments, the braid density of the intermediate portion being greater than the braid density of the proximal and distal portions.

12. The hemangioma occlusion device of claim 11, wherein the number of braided wires of the proximal and distal portions is half the number of braided wires of the intermediate portion.

13. The hemangioma occlusion device of claim 1, wherein the number of helical turns after expansion of the positioning guide structure does not exceed 5 turns.

14. The hemangioma occlusion device of claim 13, wherein the number of helical turns of the positioning and guiding structure after expansion is 1.5-3 turns.

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

16. The aneurysm occlusion device of claim 1, wherein the expanded maximum outer diameter of the positioning guide structure is less than the expanded maximum outer diameter of the expanded mesh-like structure.

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

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

19. The hemangioma occlusion device of claim 18, wherein the number of helical turns of the expanded mesh-like expansion structure is 1.1-1.5.

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

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

22. The hemangioma occlusion device of claim 1, wherein the mesh-like expansion structure and the positioning and guiding structure are integrally woven.

23. The hemangioma occlusion device of claim 1, wherein at least 1/2 coils of the positioning guide structure are helically disposed within the central lumen of the planar vortex of the mesh-like expansion structure after expansion.

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

25. The hemangioma occlusion device of claim 1, wherein the mesh-like expansion structure is woven from braided wires, the braided wires are made 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 mesh-like expansion structure has a diameter of 2-10 mm, and the expanded mesh-like expansion structure has a maximum outer diameter of 3-25 mm.

26. The hemangioma occlusion device of claim 25, wherein the mesh-like expandable structure is woven from developable woven filaments, or wherein the mesh-like expandable structure is co-woven from developable woven filaments and non-developable woven filaments.

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

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

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

30. A system for aneurysm occlusion comprising the apparatus of any of claims 1-27 and a microcatheter, wherein the mesh-like expandable structure and the positioning and guiding structure are compressed within the microcatheter and are capable of returning to an expanded state of a predetermined shape after detachment from the microcatheter.