Tumor neck plugging device

Abstract

The tumor neck plugging device comprises an implantation net body and a near-end fixing piece, the implantation net body comprises an outer-layer woven net body and a center supporting body which are integrally formed, the outer-layer woven net body surrounds the center supporting body by a circle, and the far end of the outer-layer woven net body is integrally connected with the far end of the center supporting body; the near end of the outer-layer woven mesh body is in bound connection with the near end of the central support body through a near-end fixing piece, in a natural state, the maximum outer diameter of the outer-layer woven mesh body is larger than or equal to the diameter of the aneurysm, and the height of the central support body is 25%-50% of the maximum outer diameter of the outer-layer woven mesh body. Thus, the device only covers the tumor neck and does not fully fill the whole tumor cavity, and meanwhile the upper layer and the lower layer of the outer-layer woven mesh body are not attached together.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and in particular relates to a tumor neck blocking device which only covers the tumor neck but does not fill the entire tumor cavity. Background Art

[0002] Intracranial aneurysms are pathological protrusions of the intracranial arterial wall, with an incidence of 5% to 10%. Magnetic resonance angiography (MRA) studies have shown that the incidence of unruptured aneurysms in adults aged 35 to 75 in my country is approximately 7.0%. Saccular aneurysms are the most common type of aneurysm, accounting for 80% to 90% of all intracranial aneurysms and the most common cause of non-traumatic subarachnoid hemorrhage (SAH).

[0003] Vascular interventional therapy has become the mainstream method for treating intracranial aneurysms in recent years due to its ability to bypass brain tissue and reach the lesion directly, and its minimal surgical trauma. It includes endovascular treatment and intra-aneurysm treatment. Endovascular treatment mainly involves blood flow diversion devices, the use of which improves the long-term efficacy of large and giant aneurysms and is mainly suitable for the treatment of sidewall aneurysms. However, the use of blood flow diversion devices makes patients rely on dual antiplatelet therapy for a long time, and there is a risk of hemorrhagic complications after surgery. It is not suitable for aneurysm-bearing arteries with perforating vessels. In addition, there is a certain risk of delayed rupture after using blood flow diversion devices alone to treat some large aneurysms.

[0004] Currently, intra-aneurysm treatment primarily involves coil embolization and, in recent years, some intra-aneurysm flow-disrupting devices. Coil embolization involves sequentially releasing preformed coils from a microcatheter into the aneurysm cavity. Once the cavity is densely packed with coils, the neck of the aneurysm is also covered, thereby achieving aneurysm treatment. However, not all coil embolization procedures are successful. Furthermore, for wide-necked aneurysms, coil embolization has a high recurrence rate and generally requires the implantation of additional devices to assist with packing, such as stents and flow-diverting devices. The use of multiple devices increases surgical time, treatment costs, and the likelihood of adverse events. Overall, coil embolization is inefficient and requires high physician skill and experience. Used alone, it carries the risk of aneurysm herniation, and combined with other devices, it increases the risk of ischemic complications.

[0005] Intra-aneurysmal flow-disrupting devices are safe, effective, and relatively easy to use. They primarily involve single-stage embolization of the aneurysm. They cover the aneurysm neck with a dense mesh structure, reducing the impact of blood flow on the neck, causing blood stasis and formation of a thrombus within the lumen. This, in turn, provides a "scaffolding" for endothelial cells to climb, delaying aneurysm healing. However, there is still room for improvement in the structure of intra-aneurysmal flow-disrupting devices. For example, the WEB aneurysm embolization system is primarily suitable for treating wide-diameter bifurcated aneurysms with relatively regular shapes. Its double-studded spherical structure results in a longer device release length, and the distal studs impact the aneurysm wall. Furthermore, a single spherical or cylindrical packing structure has poor long-term stability within the aneurysm cavity and is prone to extrusion and displacement. Furthermore, although the Medina embolization device utilizes a three-dimensional mesh structure, the high friction between the mesh and the aneurysm wall results in poor device stability, making it ineffective at occluding blood flow within the aneurysm and requiring its use in conjunction with a coil. Additionally, the Contour device, which covers the aneurysm neck with its mesh disc, is suitable for aneurysms with necks smaller than the maximum intraluminal diameter. However, the proximal aneurysm neck is prone to herniation, impacting blood flow in the parent artery. Furthermore, the device is limited in specifications and cannot be used to treat larger aneurysms. In summary, current intratumoral flow-disrupting devices have a limited scope of application, complex structures, and a high reliance on the physician's individual aneurysm embolization experience. The procedure is lengthy, and most require filling the entire aneurysm cavity, resulting in a significant mass effect.

[0006] It should be noted that the information disclosed in the background technology section of this application is only intended to deepen the understanding of the general background technology of this application, and should not be regarded as an admission or any form of implication that the information constitutes prior art already known to those skilled in the art. Summary of the Invention

[0007] The purpose of the present invention is to provide a tumor neck occlusion device to solve the problems of existing intratumor flow disturbance devices, such as small application range, poor stability, and large space-occupying effect.

[0008] To achieve the above-mentioned purpose, the present invention provides a tumor neck occlusion device, comprising an implantable mesh and a proximal fixing member, wherein the implantable mesh comprises an integrally formed outer braided mesh and a central support body, wherein the outer braided mesh surrounds the central support body, the distal end of the outer braided mesh is integrally connected to the distal end of the central support body, and the proximal end of the outer braided mesh is constrained and connected to the proximal end of the central support body by the proximal fixing member. In a natural state, the maximum outer diameter of the outer braided mesh is greater than or equal to the diameter of the target aneurysm, and the height of the central support body is 25% to 50% of the maximum outer diameter of the outer braided mesh.

[0009] In one embodiment, in a natural state, the height of the central support body is 25% to 35% of the maximum outer diameter of the outer braided mesh.

[0010] In one embodiment, the outer braided mesh has an upper edge and a lower edge that are arranged opposite to each other. In a natural state, the outer diameter of the upper edge is greater than, equal to, or smaller than the outer diameter of the lower edge.

[0011] In one embodiment, in a natural state, the projection outline of the outer woven mesh on a projection plane perpendicular to the height direction is circular or polygonal.

[0012] In one embodiment, the implant mesh is formed by cross-weaving a plurality of wires, the implant mesh has no exposed wire heads and boundaries, and both ends of all the wires converge at the proximal fixing piece.

[0013] In one embodiment, the distal end of the outer braided mesh and the distal end of the central support body are smoothly connected and form an opening. In a natural state, the maximum diameter of the opening is less than or equal to 20% of the maximum outer diameter of the outer braided mesh.

[0014] In one embodiment, the implant mesh is woven from at least one of shape memory alloy wire and developable wire.

[0015] In one embodiment, the wire diameter is 0.0005 in to 0.002 in, and the number of the wires is 24 to 196.

[0016] In one embodiment, the central support body is prepared from a central wire bundle, one end of which extends along a predetermined path and is woven to form the outer woven mesh surrounding the central support body.

[0017] In one embodiment, in a natural state, the maximum outer diameter of the outer braided mesh is 3 mm to 20 mm.

[0018] As described above, in the aneurysm neck occlusion device provided by the present invention, a central support body is provided within the outer braided mesh, the height of which is 25% to 50% of the maximum outer diameter of the outer braided mesh. This configuration allows the aneurysm neck occlusion device to only fill the lower half of the aneurysm, rather than filling the entire aneurysm cavity. This reduces the impact on the aneurysm dome, which is prone to rupture, and also reduces the mass effect of large aneurysms. Furthermore, due to the height restriction of the central support body, the upper and lower layers of the outer braided mesh will not adhere to each other, thus providing the aneurysm neck occlusion device with good flexibility, allowing it to unfold and adhere to the aneurysm wall adjacent to the aneurysm neck, thereby stably supporting the aneurysm neck occlusion device in the lower half of the aneurysm, making it less likely to shift or herniate the proximal end of the aneurysm neck into the parent artery. Since it does not need to fill the entire aneurysm cavity, the aneurysm neck occlusion device no longer needs to adapt to the overall shape of the aneurysm, making it suitable for aneurysms of varying sizes, thereby increasing the device's applicability. At the same time, the outer woven mesh can build a "bridge" at the neck of the aneurysm, weakening the blood flow impacting the aneurysm cavity and providing support for the endothelialization of the neck, ultimately achieving occlusion of the aneurysm. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0020] Figure 1 1 is a schematic structural diagram of a tumor neck occlusion device provided by an embodiment of the present invention;

[0021] Figure 2 yes Figure 1 The image shows a scene of an aneurysm being occluded by an aneurysm neck occlusion device;

[0022] Figure 3 is a scene diagram of an aneurysm occluded by the aneurysm neck occlusion device of the comparative embodiment;

[0023] Figure 4 is a schematic structural diagram of a tumor neck occlusion device provided by another embodiment of the present invention;

[0024] Figure 5 yes Figure 4 The aneurysm neck occlusion device is shown as a top view when deployed in a natural state;

[0025] Figure 6 This is a scene diagram of an aneurysm occluded by an aneurysm neck occlusion device provided by another embodiment of the present invention;

[0026] Figure 7 1 is a schematic structural diagram of a tumor neck occlusion device provided by another embodiment of the present invention;

[0027] Figure 8This is a scene diagram of an aneurysm occluded by an aneurysm neck occlusion device provided by another embodiment of the present invention. DETAILED DESCRIPTION

[0028] To make the objects, advantages, and features of the present invention more clearly apparent, the present invention is further described below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale. They are only used to conveniently and clearly assist in illustrating the purposes of the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structure. In particular, different drawings may need to illustrate different focuses and sometimes use different scales.

[0029] As used in the present invention, the singular forms "a", "an" and "the" include plural objects, the term "or" is generally used in a sense including "and / or", the term "several" is generally used in a sense including "at least one", and the term "at least two" is generally used in a sense including "two or more". In addition, the term "proximal end" is generally the end close to the operator of the medical device, the term "distal end" is generally the end away from the operator of the medical device, "one end" and "the other end" as well as "proximal end" and "distal end" generally refer to two corresponding parts, which not only include endpoints. The terms "installed", "connected" and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. In addition, as used in the present invention, "one element is disposed on another element" generally only indicates that there is a connection, coupling, cooperation, or transmission relationship between the two elements, and the connection, coupling, cooperation, or transmission between the two elements may be direct or indirect through an intermediate element. It should not be understood as indicating or implying a spatial positional relationship between the two elements. That is, one element can be in any orientation, such as inside, outside, above, below, or to one side of another element, unless the content clearly indicates otherwise. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0030] The term "height" used herein refers to the dimension of the aneurysm neck closure device along its axis, while the term "outer diameter" or "diameter" refers to the dimension of the aneurysm neck closure device perpendicular to its axis. The height of the aneurysm neck closure device is measured from the aneurysm neck to the aneurysm dome. For the purposes of this invention, the term "maximum outer diameter of the outer braided mesh" refers to the maximum diameter of the expanded aneurysm neck closure device as projected on a plane perpendicular to the aneurysm axis.

[0031] The core idea of ​​the present invention is to provide a tumor neck occlusion device to solve the problems of existing intratumor flow disturbance devices, such as small application range, poor stability, and large space-occupying effect.

[0032] The following description is given with reference to the accompanying drawings.

[0033] Reference Figures 1 and 2 ,as well as Figures 4 to 8 As shown, an embodiment of the present invention provides a tumor neck occlusion device, which includes an implantable mesh 1 and a proximal fixing member 2. The implantable mesh 1 includes an integrally formed outer braided mesh 11 and a central support body 12. The outer braided mesh 11 surrounds the central support body 12, thereby confining the central support body 12 inside the outer braided mesh 11. The distal end 101 of the outer braided mesh 11 is integrally connected to the distal end 101 of the central support body 12. The proximal end 102 of the outer braided mesh 11 is constrained and connected to the proximal end 102 of the central support body 12 by the proximal fixing member 2. The proximal fixing member 2 is used to be detachably connected to the push rod 10. The proximal fixing member 2 is preferably made of a radiopaque developable material, such as but not limited to platinum, iridium, tantalum, precious metal alloys, etc. The structure of the proximal fixing member 2 is not limited, and includes but is not limited to a sleeve. The proximal fixing member 2 and the push rod 10 can be released by any method known in the art, which is not limited by the present invention.

[0034] The outer braided mesh 11 is a woven structure, while the central support body 12 can be a woven or non-woven structure. Preferably, the central support body 12 is also a woven structure. A non-woven structure can be understood as a structure in which the wires are not cross-woven, but rather intertwined or entangled in other ways to form the central support body 12. In short, it is sufficient to ensure that the central support body 12 has a certain degree of support and flexibility. In this embodiment, the implant mesh 1 is composed of multiple cross-woven wires, which has good support and flexibility.

[0035] In one preparation method, a braided mesh tube is first prepared, and then one end of the mesh tube is turned outward. After the turning outward, the turned-out end of the mesh tube is aligned with the unturned end and joined. The joined ends are then fastened and fixed by a proximal fixing member 2. Finally, after heat treatment and shaping, the implant mesh body 1 of the desired shape and size can be obtained. In this method, the implant mesh body 1 is mainly prepared through folding and heat setting processes.

[0036] In another preparation method, a central wire bundle composed of several wires can be provided first, and a central support body 12 can be pre-formed by the central wire bundle. Then, one end of the central wire bundle is further extended along a predetermined path and woven to form an outer woven mesh body 11 surrounding the central support body 12. After the weaving is completed, the two ends of all the wires are gathered together at the proximal fixing member 2 to be bound and fixed. Finally, after heat treatment and shaping, the implant mesh body 1 of the desired shape and size is obtained. In one embodiment, the predetermined path is: starting from the central wire bundle, weaving upward (i.e., toward the distal end 101) and extending outward, and then weaving downward (i.e., toward the proximal end 102) and extending inward after reaching the desired boundary, until the other ends of all the wires are woven and converged to one end of the central wire bundle, and then the two ends of all the wires are bound and fixed by the proximal fixing member 2. Different from the previous method, this method can directly prepare the implant mesh body 1 through a weaving process and a heat setting process. The process is relatively simpler, more convenient to make, and easier to shape.

[0037] It should be understood that when the implant mesh 1 is integrally formed, there is no rivet point at the connection between the distal end 101 of the outer braided mesh 11 and the distal end 101 of the central support body 12, but because it has been heat-treated and shaped, the distal end 101 will not fall apart during the release process. The implant mesh 1 only forms an unreleasable rivet point at the proximal end 102 due to the restraint and fixation of the wire head.

[0038] In practice, the aneurysm neck occlusion device of the present invention has at least one natural state, one compressed state, and one expanded state. The natural state refers to the naturally expanded state of the aneurysm neck occlusion device when not constrained by external forces. In actual use, the aneurysm neck occlusion device of the present invention can be delivered via a microcatheter. Accordingly, the aneurysm neck occlusion device exhibits a compressed state during delivery within the microcatheter, and after being pushed out of the microcatheter into the aneurysm cavity, it can spontaneously return to its expanded state, filling the aneurysm. It should be understood that the dimensions described below primarily refer to the dimensions of the aneurysm neck occlusion device in its natural state.

[0039] like Figure 2 、 Figure 6 and Figure 8As shown, in actual application, the aneurysm neck occlusion device of the present invention does not need to fill the entire aneurysm cavity of the aneurysm 20, but only fills the lower half of the aneurysm 20 and covers the aneurysm neck opening 21. This can reduce the impact on the easily ruptured aneurysm dome, reduce the damage of the device to the aneurysm, and reduce the space-occupying effect of large aneurysms. It should also be noted that filling the lower half of the aneurysm 20 does not mean filling half of the aneurysm 20, but should be understood as partially filling the aneurysm 20 rather than the entire aneurysm 20. For example, half of the aneurysm 20 can be filled, more than half of the aneurysm 20 can be filled, or less than half of the aneurysm 20 can be filled. In addition, the aneurysm neck occlusion device of the present invention can also smoothly cover the aneurysm neck opening 21, which is more conducive to endothelial cell climbing and vascular reconstruction. It can also reduce the impact of the implant on the branch arteries and avoid the occurrence of late ischemic complications.

[0040] To this end, the height of the implanted mesh 1 is limited by the height of the central support body 12. Specifically, in the natural state, the height (H) of the central support body 12 is 25% to 50% of the maximum outer diameter (D) of the outer braided mesh 11. In this way, while achieving the above-mentioned effects, it can also prevent the upper and lower layers (along the height direction) of the outer braided mesh 11 from being tightly attached together, so that the aneurysm neck occlusion device has better flexibility and can unfold and fit the aneurysm wall near the aneurysm neck opening, thereby stably supporting the aneurysm neck occlusion device in the lower half of the aneurysm, making it difficult to shift and the proximal end of the aneurysm neck occlusion device from herniating into the aneurysm-bearing artery. Since it is not necessary to fill the entire aneurysm cavity, the aneurysm neck occlusion device no longer needs to adapt to the overall shape of the aneurysm, and can therefore be applied to aneurysms of different specifications, thereby increasing the scope of application of the aneurysm neck occlusion device. At the same time, the outer braided mesh 11 can build a "bridge" at the aneurysm neck 21 to weaken the blood flow impacting the aneurysm cavity, while providing support for the endothelialization of the aneurysm neck, ultimately achieving occlusion of the aneurysm and achieving better treatment results.

[0041] The height of the central support body 12 can also be further optimized to make the aneurysm neck occlusion device more applicable and to cover some short and wide aneurysms. Thus, it is further preferred that, in the natural state, the height (H) of the central support body 12 is 25% to 35% of the maximum outer diameter (D) of the outer braided mesh 11, such as 25%, 30% or 35%. When the mesh body 1 is implanted according to this size design, the height of the implanted mesh body 1 is more optimal, which can not only cover aneurysms of more specifications, but also further improve the flexibility and support of the aneurysm neck occlusion device.

[0042] Furthermore, in its natural state, the maximum outer diameter (D) of the outer braided mesh 11 should also be greater than or equal to the diameter of the aneurysm 20, so that after deployment, the implanted mesh 1 can be securely supported within the aneurysm by its own radial support force. It should be understood that the aneurysm diameter is the maximum diameter of the aneurysm, or a larger diameter of the aneurysm 20, as long as the implanted mesh 1 can adequately conform to the aneurysm wall and occlude the aneurysm neck.

[0043] The outer braided mesh 11, after being deployed, can be spherical, cylindrical, or in other shapes. More preferably, the outer braided mesh 11, after being deployed, is cylindrical, as cylindrical structures offer greater flexibility and support. Thus, compared to a multi-layer sheet structure that adheres to each other, the implantable mesh 1 of the present invention offers greater flexibility and prevents the formation of a conical structure at the neck of the aneurysm, thereby preventing the aneurysm from herniating and affecting blood flow in branch vessels.

[0044] like Figure 1 、 Figure 4 and Figure 7 As shown, in some embodiments, the outer braided mesh body 11 is a cylindrical mesh body having an upper edge 111, a lower edge 112, and a side wall 113 connecting the upper edge 111 and the lower edge 112. The upper edge 111 corresponds to one side of the distal end 101, and the lower edge 112 corresponds to one side of the proximal end 102. In a natural state, the outer diameter of the upper edge 111 is greater than, equal to, or less than the outer diameter of the lower edge 112. More preferably, the outer diameter of the upper edge 111 is greater than or equal to the outer diameter of the lower edge 112. The larger of the outer diameters of the upper edge 111 and the lower edge 112 is defined as the maximum outer diameter (D) of the outer braided mesh body 11. In a natural state, the maximum distance between the upper edge 111 and the lower edge 112 is defined as the height (H) of the central support body 12. In this way, the distance between the upper edge 111 and the lower edge 112 is limited by the central support body 12 to prevent the two from fitting together. The upper edge 111 and the lower edge 112 at a certain distance are equivalent to two layers of dense mesh barriers, which will produce two blocks on the blood flow impacting the tumor cavity. Its flow disturbance effect is better than a single layer of dense mesh and better than multiple layers of dense mesh attached to each other.

[0045] The shape of the outer braided mesh 11 can be further optimized to further improve the flexibility and support of the implanted mesh 1. Further preferably, in the natural state, the projection contour of the outer braided mesh 11 on the projection plane perpendicular to the height direction is circular or polygonal. The projection contour can also be understood as the projection shape of the side wall 113. When the projection contour is a polygon, such as a triangle, quadrilateral, pentagon, hexagon or other polygon, more preferably, a hexagon is used. It should be understood that when the projection contour is circular, the implanted mesh 1 has better flexibility and can better fit the aneurysm wall; when the projection contour is a polygon, the side wall 113 has many more planes, so that the upper edge 111 and the lower edge 112 also have many more corners, which makes the implanted mesh 1 more supportive, can be more stably supported in the aneurysm, and is more suitable for large-scale aneurysms.

[0046] In this embodiment, the implant mesh 1 is formed by cross-weaving a plurality of wires, and the material of the wires is not particularly limited. Preferably, the implant mesh 1 is woven from at least one of a shape memory alloy wire and a developable wire. Shape memory materials include metal materials with shape memory functions, such as nickel titanium (Ni-Ti) alloy, nickel titanium cobalt alloy (Ni-Ti-Co), double-layer composite metal wire (Ni-Ti@Pt), etc. Shape memory materials can also be selected from polymer materials with certain shape recovery capabilities, such as polydioxanone (PDO), (lactide-ε-caprolactone) copolymer (PLC), polyurethane (PU), polynorbornene amorphous polymer, etc. Preferably, the shape memory alloy wire and the developable wire are mixed to prepare the implant mesh 1, so that the implant mesh 1 has good elasticity and can also be developed. For example, the shape memory wire can be mixed with a metal wire with good developability (Pt, Pt-Ir, etc.), or the shape memory wire can be mixed with a composite wire (DFT). Preferably, the wire diameter is 0.0005 in to 0.002 in, and the number is 24 to 196 wires.

[0047] Furthermore, the implant mesh 1 (including the upper edge 111, sidewalls 113, and lower edge 112) has no exposed wire ends or boundaries, and all wires are closed at both ends and converge at the proximal fixing member 2 (i.e., the proximal rivet point). This structure exerts a relatively uniform force on the aneurysm, minimizing the risk of aneurysm damage caused by the implanted device.

[0048] Preferably, the distal end 101 of the outer braided mesh 11 and the distal end 101 of the central support body 12 are connected in a smooth transition to reduce the stress on this part. Furthermore, an opening 103 is formed at the smooth transition connection. The opening 103 is as small as possible to better limit the distance between the upper and lower edges, so that the upper and lower edges remain as parallel as possible when filled in the aneurysm, the distance is stable, the distance will not be reduced, and the flexibility of the aneurysm neck occlusion device will not be changed. Preferably, in the natural state, the maximum diameter of the opening 103 is less than or equal to 20% of the maximum outer diameter (D) of the outer braided mesh 11.

[0049] The maximum outer diameter of the outer braided mesh 11 in its natural state can be determined according to the diameter of the aneurysm to which it is applied. In order to be applicable to most aneurysms, preferably, the maximum outer diameter of the outer braided mesh 11 in its natural state is 3 mm to 20 mm, more preferably 4 mm to 15 mm.

[0050] The following further illustrates the tumor neck occlusion device provided by the present invention with reference to several specific examples.

[0051] like Figure 1 As shown, in a specific embodiment, in a natural state, the outer diameter of the upper edge 111 and the outer diameter of the lower edge 112 are almost equal, the height (H) of the central support body 12 is 25% of the maximum outer diameter (D) of the outer braided mesh body 11, and the projection shape of the side wall 113 is circular. Figure 2 As shown, after being inserted into aneurysm 20, the outer diameters of upper edge 111 and lower edge 112 are nearly equal, allowing the entire outer braided mesh 11 to smoothly and flexibly fill aneurysm 20. Furthermore, lower edge 112 closely adheres to the aneurysm wall in the lower half of the aneurysm cavity. Because the central support body 12 limits its height, upper edge 111 lies almost parallel to and above lower edge 112, not completely filling the aneurysm cavity. Thus, upper edge 111 and lower edge 112 form two flow barriers within the aneurysm cavity, significantly reducing the impact of blood flow on the aneurysm cavity and helping to prevent blood from stagnating within the aneurysm cavity and forming thrombi. Furthermore, the sufficient height between upper edge 111 and lower edge 112 makes the entire aneurysm neck occlusion device relatively flexible, allowing for a relatively smooth coverage of the aneurysm neck opening 21. This eliminates the problem of the upper edge 111 and lower edge 112 abutting against each other to form a tapered tip, thus preventing the aneurysm neck opening 21 from herniating. It should also be understood that a smooth tumor neck coverage is more conducive to the climbing of endothelial cells and vascular reconstruction, while also reducing the impact of the implant on the branch arteries and avoiding the occurrence of late ischemic complications.

[0052] Refer again Figure 3In the comparative embodiment shown, the braided mesh 11' lacks a central support 12. In this case, the upper and lower mesh layers of the braided mesh 11' cling tightly together, making the device rigid and less flexible. The entire braided mesh 11' cannot be smoothly and flexibly packed within the aneurysm 20. Furthermore, the proximal end forms a tapered shape, herniating beyond the aneurysm neck 21 and affecting the parent artery. Therefore, the central support 12 plays a crucial role.

[0053] like Figure 4 and Figure 5 As shown, in another specific embodiment, in the natural state, the outer diameter of the upper edge 111 and the outer diameter of the lower edge 112 are also almost equal, and the height (H) of the central support body 12 continues to be 25% of the maximum outer diameter (D) of the outer braided mesh body 11, but Figure 1 The difference is that the projected shape of the side wall 113 is Figure 5 The schematic diagram shows a hexagon. However, the edges of the polygon can be straight lines, curves or arcs. Correspondingly, Figure 6 As shown, after being packed within aneurysm 20, lower edge 112 closely adheres to the aneurysm wall in the lower half of the aneurysm cavity. Upper edge 111, limited in height by central support body 12, lies almost parallel to and above lower edge 112, not completely filling the aneurysm cavity. This embodiment functions similarly, with upper edge 111 and lower edge 112 also forming two flow barriers within the aneurysm cavity, reducing the impact of blood flow on the aneurysm cavity and helping to prevent blood from stagnating within the cavity and forming thrombi.

[0054] However, it should be understood that as the maximum outer diameter of the implant mesh 1 increases, the implant mesh 1 becomes more flexible. In this case, configuring the projection of the sidewalls 113 to be a hexagon or other polygon can increase the radial support force of the implant mesh 1, preventing the device from becoming too flexible due to the increased outer diameter and being unable to stably support the aneurysm cavity, causing displacement and rendering the aneurysm incurable or recurring. It should also be understood that as the height of the central support body 12 increases, the implant mesh 1 also becomes more flexible. In this case, configuring the projection of the sidewalls 113 to be a hexagon or other polygon can balance the flexibility and support of the entire implant mesh 1, enabling it to effectively occlude the aneurysm.

[0055] like Figure 7 As shown, in another embodiment, in its natural state, the outer diameter of the upper edge 111 is greater than that of the lower edge 112, the height (H) of the central support body 12 is 35% of the maximum outer diameter (D) of the outer braided mesh 11, and the projection of the sidewall 113 is circular. Compared to the two aforementioned embodiments, this embodiment increases the height of the central support body 12. This increased height of the central support body 12 improves the flexibility of the implanted mesh 1.

[0056] In more detail, Figure 8As shown, since the outer diameter of the lower edge 112 is smaller than that of the upper edge 111, a kind of arc-shaped transition is formed between the upper and lower edges, so that the lower half of the device can better fit the neck of the saccular aneurysm. Moreover, the upper edge 111 is long and can extend upward better, maintaining the stable support of the device in the aneurysm to a greater extent. Therefore, after being deployed in the aneurysm 20, the upper edge 112 is deployed in parallel with the lower edge 112, the lower edge 112 is stably fitted to the neck of the aneurysm, and the upper edge 111 extends to a greater extent into the aneurysm cavity at its upper part, providing stable support for the device under the restriction of the central support body 12. In this way, there is no need to consider the overall shape of the aneurysm, only the mesh body 1 needs to be implanted to stably fit its lower half, thereby shortening the operation time. At the same time, it also greatly increases the range of aneurysms that the device is adapted to, providing more options for aneurysm treatment for more patients.

[0057] In summary, the tumor neck occlusion device provided by the present invention can achieve at least the following beneficial effects:

[0058] (1) By setting a central support body with a certain height, the height of the implanted mesh is limited. While maintaining the device's flexibility and stable support, the device only needs to fit the lower half of the aneurysm cavity to achieve smooth coverage of the aneurysm neck, reducing the damage of the implant to the aneurysm. At the same time, as the aneurysm neck becomes endothelialized, the aneurysm will continue to shrink, reducing the occurrence of the space-occupying effect. Moreover, when selecting the device, there is no need to consider the overall shape of the aneurysm. It is only necessary to consider the compatibility of the device with the lower half of the aneurysm, making the device widely applicable.

[0059] (2) The entire device has a simple structure and a simple release operation, which can reduce the reliance on the doctor's personal aneurysm embolization experience during the operation and shorten the operation time. In addition, the device has a short release length and does not contact the aneurysm dome that is prone to rupture, which reduces the risk of perioperative bleeding.

[0060] (3) Under the constraints of the central support body, the lower edge can fit the aneurysm neck and the upper edge can be parallel to each other, thereby providing better support and reducing the possibility of compression and displacement of the device after implantation. In addition, the separation of the upper and lower edges can provide two layers of turbulence, greatly reducing the impact of blood flow on the aneurysm cavity and accelerating the healing of the aneurysm.

[0061] (4) The entire device has good flexibility and can form a smooth coverage on the tumor neck without forming a protruding tumor neck opening;

[0062] (5) The device is completely located within the aneurysm, avoiding the use of dual antiplatelet drugs.

[0063] The above description is only a description of the preferred embodiment of the present invention and does not limit the scope of the present invention. Any changes and modifications made by ordinary technicians in the field of the present invention based on the above disclosure are within the scope of protection of the technical solution of the present invention.

Claims

1. A tumor neck occlusion device, characterized in that: It includes an implantable mesh body and a proximal fixing device, wherein the implantable mesh body includes an integrally formed outer braided mesh body and a central support body, the outer braided mesh body surrounds the central support body, the distal end of the outer braided mesh body is integrally connected with the distal end of the central support body, the proximal end of the outer braided mesh body is bound and connected with the proximal end of the central support body by the proximal fixing device, in a natural state, the maximum outer diameter of the outer braided mesh body is greater than or equal to the diameter of the aneurysm, and the height of the central support body is 25% to 50% of the maximum outer diameter of the outer braided mesh body.

2. The tumor neck occlusion device according to claim 1, characterized in that: In a natural state, the height of the central support body is 25% to 35% of the maximum outer diameter of the outer braided mesh body.

3. The tumor neck occlusion device according to claim 1 or 2, characterized in that: The outer braided mesh body has an upper edge and a lower edge that are arranged opposite to each other. In a natural state, the outer diameter of the upper edge is greater than, equal to, or smaller than the outer diameter of the lower edge.

4. The tumor neck occlusion device according to claim 3, characterized in that: In a natural state, the projection outline of the outer woven mesh body on a projection plane perpendicular to the height direction is circular or polygonal.

5. The tumor neck occlusion device according to claim 3, characterized in that: The implant mesh body is formed by cross-weaving a plurality of wires, the implant mesh body has no exposed wire heads and boundaries, and both ends of all the wires converge at the proximal fixing piece.

6. The tumor neck occlusion device according to claim 5, characterized in that: The distal end of the outer braided mesh body and the distal end of the central support body are smoothly connected and form an opening. In a natural state, the maximum diameter of the opening is less than or equal to 20% of the maximum outer diameter of the outer braided mesh body.

7. The tumor neck occlusion device according to claim 5, characterized in that: The implant mesh is woven from at least one of shape memory alloy wires and developable wires.

8. The tumor neck occlusion device according to claim 5, characterized in that: The wire diameter of the wire is 0.0005 in to 0.002 in, and the number of the wires is 24 to 196.

9. The tumor neck occlusion device according to claim 1 or 2, characterized in that: The central support body is prepared by a central wire bundle, one end of which extends along a predetermined path and is woven to form the outer woven mesh body surrounding the central support body.

10. The tumor neck occlusion device according to claim 1 or 2, characterized in that: In a natural state, the maximum outer diameter of the outer braided mesh is 3 mm to 20 mm.

Images