An intratumoral embolus and an intratumoral embolization device having the same

Abstract

The present application relates to the technical field of medical devices, in particular to an intratumoral embolism device, comprising an intratumoral embolism device body with at least two layers of mesh structures, the mesh structures are formed by interlaced weaving of metal wires, the intratumoral embolism device body comprises a first mesh structure and a second mesh structure which are not interwoven, the metal wire arrangement on the first mesh structure is different from that on the second mesh structure, so that the metal wires of the first mesh structure and the second mesh structure are staggered and not completely overlapped, which is beneficial to make the first metal wire and the second metal wire of the first mesh structure not completely overlap the third metal wire and the fourth metal wire of the second mesh structure after the first mesh structure and the second mesh structure overlap, the mesh of the second mesh structure will further divide the mesh of the first mesh structure into smaller meshes, increase the mesh density by several times, and further enhance the blocking effect of the intratumoral embolism device body.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an intratumoral embolization device and an intratumoral embolization device with the same. BACKGROUND

[0002] Intracranial aneurysm is a pathological expansion of the weak area of the intracranial blood vessel wall due to long-term impact of unstable blood flow, which has the characteristics of high morbidity, high disability rate and high mortality, and seriously endangers the life and health of patients. The wide-necked aneurysm at the bifurcation of the intracranial artery is a difficult point for interventional treatment because of the large blood vessel branches issuing from near the aneurysm neck. The traditional treatment method for wide-necked aneurysm at the bifurcation is relatively complex, and both stent-assisted coil embolization and flow diversion devices have difficulty in overcoming this problem. In recent years, the intratumoral embolization device can interfere with the blood flow into the aneurysm at the aneurysm neck, overcoming the shortcomings of traditional devices. After the intratumoral embolization device is implanted into the aneurysm, the mesh structure will block the aneurysm neck. When the blood flow flows into the aneurysm, the flow rate will be greatly reduced under the blockage of the mesh structure of the intratumoral embolization device, weakening the impact of the blood flow on the aneurysm. The blood flow into the aneurysm will also be retained in the aneurysm for a long time under the blockage of the mesh structure, until the intratumoral thrombus is formed, and the aneurysm is closed.

[0003] For example, the related technology (application number 202211563739.4) discloses an intratumoral dense mesh stent and a stent system. The intratumoral dense mesh stent includes a woven mesh, a sleeve and a connecting rod. The woven mesh has opposite end portions and edge portions, and the woven mesh is a double-layer structure. The sleeve is fixedly connected to the end portions of the woven mesh, and the connecting rod is connected to the sleeve, with one end of the connecting rod wrapped inside the sleeve and the other end of the connecting rod exposed outside the sleeve.

[0004] However, the existing intratumoral embolization device also has some shortcomings. For example, the mesh density of the intratumoral embolization device at the aneurysm neck is small, the blood flow impact force is reduced, the blood retention effect in the aneurysm is not obvious, and the blockage effect is poor. The conventional way to increase the mesh density of the intratumoral embolization device is to increase the amount of metal wire and weave a smaller mesh area, or to stack more layers. This has the disadvantage of significantly increasing the overall support force of the intratumoral embolization device. The increase in support force increases the pressure exerted by the intratumoral embolization device on the aneurysm wall. The aneurysm wall is relatively weak and is prone to rupture and other serious damage.

[0005] Therefore, an intratumoral embolization device and an intratumoral embolization device with the same are proposed. SUMMARY

[0006] The object of the present invention is to provide an intratumoral embolizer and an intratumoral embolization device having the same, so as to solve the problem that the grid density of the intratumoral embolization device at the aneurysm neck is small and the effect of slowing down the blood flow impact force is poor in the above-mentioned background technology.

[0007] To achieve the above object, the present invention provides the following technical solution: An intratumoral embolizer, an intratumoral embolizer main body formed by interleaving metal wires, the intratumoral embolizer main body includes a first mesh structure and a second mesh structure that are mutually adhered and do not interweave with each other. The first mesh structure further includes a first metal wire and a second metal wire, and the first metal wire and the second metal wire are interleaved to form a plurality of first meshes. The second mesh structure includes a third metal wire and a fourth metal wire, and the third metal wire and the fourth metal wire are interleaved to form a second mesh. The first metal wire and the second metal wire on the first mesh structure do not interweave with the third metal wire and the fourth metal wire on the second mesh structure;

[0008] The intratumoral embolizer main body is provided with a top, a middle part and a bottom. The first mesh structure and the second mesh structure are integrally connected at the top of the intratumoral embolizer main body to form a smoothly transitional connecting part, and converge and are fixedly connected at the bottom of the intratumoral embolizer main body;

[0009] The arrangement of the first metal wire and the second metal wire on the first mesh structure is different from the arrangement of the third metal wire and the fourth metal wire on the second mesh structure, so that the first metal wire and the second metal wire on the first mesh structure are staggered and do not completely overlap the third metal wire and the fourth metal wire on the second mesh structure, and the first mesh and the second mesh are staggered and do not completely overlap.

[0010] Preferably, when the intratumoral embolizer main body is unfolded, it is arranged in a funnel shape, and the size relationship of the top, the middle part and the bottom of the intratumoral embolizer main body is D1>D2>D3, where D1 is the size of the top, D2 is the size of the middle part, and D3 is the size of the bottom.

[0011] Preferably, the middle part of the intratumoral embolizer main body includes a first curved surface and a second curved surface. Both the first curved surface and the second curved surface are arc-shaped curved surfaces and have different bending directions. The first curved surface is closer to the bottom relative to the second curved surface. The first curved surface is concave in the direction of blood flow impact, the bending radius of the first curved surface is T1, the second curved surface is convex in the direction of blood flow impact, the bending radius of the second curved surface is T2, and the bending radius T1 and the bending radius T2 satisfy T1<T2. The first curved surface and the second curved surface are connected and the transition between them is smooth.

[0012] Preferably, the first and second mesh structures have the same profile size, the first and second mesh structures are formed by a plurality of arc-shaped metal wires, the first, second, third and fourth metal wires are all shape memory materials, one end of the first, second, third and fourth metal wires converges at the bottom of the intratumoral embolism device body, the other end of the first metal wire diverges towards the top and is uniformly arranged in a circle on the first mesh structure, the first and third metal wires are clockwise metal wires, and the second and fourth metal wires are counterclockwise metal wires, the two ends of the first and second metal wires are connected at the top and the bottom to form a closed loop, and the third and fourth metal wires are connected at the top to form a closed loop, and the areas of the first and second meshes gradually decrease from the top to the bottom.

[0013] Preferably, the deflection angles of the first and second metal wires with respect to the horizontal line are α1, and the deflection angles of the third and fourth metal wires with respect to the horizontal line are α2, and α1≠α2.

[0014] Preferably, the relationship between the deflection angles α1 and α2 satisfies: wherein the total number of the first and second metal wires is n, the total number of the first and second metal wires is equal to the total number of the third and fourth metal wires, and k is any integer.

[0015] Preferably, the bending radii of the first and second metal wires in the first mesh structure are R1, and the bending radii of the third and fourth metal wires in the second mesh structure are R2, and the relationship between the bending radii satisfies R1≠R2.

[0016] Preferably, the intratumoral embolism device body has C layers of mesh structures, C satisfies C≥2 and is an even number, the Xth layer is connected to the last Xth layer (X=1; 2; 3; 4; 5…), and all metal meshes are connected in turn and wrapped around other metal meshes N.

[0017] Preferably, the intratumoral embolism device body further comprises third and fourth mesh structures that are attached to each other but not interwoven, the third and fourth mesh structures are integrally connected at the top of the intratumoral embolism device body and are fixedly connected together at the bottom, the third and fourth mesh structures are wrapped between the first and second mesh structures, the third and fourth mesh structures have the same profile size as the first and second mesh structures, and the metal wire arrangements of the first, second, third and fourth mesh structures are different, so that the metal wires on the first mesh structure, the metal wires on the second mesh structure, the metal wires on the third mesh structure and the metal wires on the fourth mesh structure are staggered and not completely overlapped.

[0018] The application also provides: an intratumoral embolization device comprising the intratumoral embolization device of any one of the above and a delivery system for delivering and deploying the intratumoral embolization device;

[0019] The delivery system comprises a delivery device and a release wire, the delivery device is an elongated rod structure, the distal end of the delivery device is connected with the main body of the intratumoral embolization device through the release wire, the delivery device is used for delivering and implanting the intratumoral embolization device into an aneurysm, and the release of the intratumoral embolization device is realized by the breaking of the release wire after the deployment of the intratumoral embolization device is completed.

[0020] The application has the following beneficial effects:

[0021] 1. The application is advantageous in making the first wire and the second wire of the first mesh structure not completely overlap the third wire and the fourth wire of the second mesh structure after the first mesh structure and the second mesh structure overlap, the mesh of the second mesh structure can divide the mesh of the first mesh structure into smaller meshes, the mesh density is increased by several times under the condition that the number of layers of the main body of the intratumoral embolization device is unchanged, and the occlusion effect of the main body of the intratumoral embolization device is further enhanced.

[0022] 2. The application is advantageous in dividing the mesh formed by the wire with a larger bending radius into a larger number of meshes with smaller areas by using the wire with a smaller bending radius, the mesh density is increased by several times under the condition that the number of layers of the main body of the intratumoral embolization device is unchanged, and the occlusion effect on the aneurysm is significantly enhanced.

[0023] 3. The application is advantageous in enhancing the mesh density of the surface of the main body of the intratumoral embolization device by designing different numbers of layers of the mesh structure of the main body of the intratumoral embolization device, the effect of slowing down the blood flow impact is stronger, the occlusion and embolization effect on the aneurysm is better, and the intratumoral embolization device is suitable for different types of aneurysms. However, the more the number of layers is, the stronger the self-expanding force of the main body of the intratumoral embolization device is. Since the self-expanding force of the main body of the intratumoral embolization device directly acts on the aneurysm wall, the aneurysm wall is relatively weak, and the expansion force that is too strong can increase the risk of aneurysm rupture. Therefore, the optimal number of layers C of the main body of the intratumoral embolization device for the intracranial aneurysm at the bifurcation of the artery is in the range of 2≤C≤4, and the optimal number of layers is an even number. Within this range of the number of layers, the intratumoral embolization device can balance the good occlusion effect and moderate self-expanding force.

[0024] 4. The intravascular embolization device of the present application can make the blood flow to the branch vessels more smoothly after complete implantation by designing different sizes of the top, middle and bottom parts. This design can reduce the impact of blood flow on the intravascular embolization device and the aneurysm neck, ensuring that the intravascular embolization device will not be displaced or deformed under the impact of blood flow for a long time. Since the blood flow is shunted and directed to normal blood vessels, platelets cannot accumulate in large quantities at the aneurysm neck, significantly reducing the risk of free thrombus formation and protecting the health of the patient. The area of the first mesh and the second mesh gradually decreases from the top to the bottom, making the mesh at the bottom of the intravascular embolization device body small and dense, significantly reducing the impact of blood flow on the aneurysm and enhancing the blocking effect. The mesh at the top of the intravascular embolization device body is larger and smoother on the outside, causing less damage and irritation to the aneurysm wall when in contact with the aneurysm wall, making it safer to implant the aneurysm. BRIEF DESCRIPTION OF DRAWINGS

[0025] In order to more clearly illustrate the technical solutions in the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings described below are only a part of the present application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0026] Figure 1 The structure diagram of the intravascular embolization device and the delivery system of the present application;

[0027] Figure 2 The structure diagram of the intravascular embolization device of the present application;

[0028] Figure 3 The structure diagram of the intravascular embolization device of the present application; Figure 2

[0029] The structure diagram of the intravascular embolization device of the present application; Figure 4 Figure 2 The structure diagram of the intravascular embolization device and the delivery system of the present application;

[0030] Figure 5 The structure diagram of the intravascular embolization device of the present application;

[0031] Figure 6 The structure diagram of the intravascular embolization device of the present application;

[0032] Figure 7 The structure diagram of the intravascular embolization device of the present application;

[0033] Figure 8 The structure diagram of the intravascular embolization device of the present application; Figure 2

[0034] The structure diagram of the first mesh structure of the intravascular embolization device of the present application from the top view;​Figure 9 Structure diagram of the first and second mesh structures of the first embodiment of the present application;

[0035] Figure 10 Structure diagram of the first and second mesh structures of the second embodiment of the present application;

[0036] Figure 11 Structure diagram of the first and second mesh structures of the second embodiment of the present application after superposition;

[0037] Figure 12 Structure diagram of the first and second mesh structures of the second embodiment of the present application after superposition;

[0038] In the figure, the marks are: 1, intratumoral embolus main body; 11, top; 111, connecting part; 12, middle part; 121, first curved surface; 122, second curved surface; 13, bottom; 14, collar; 2, delivery device; 3, release wire; 4, first mesh structure; 41, first metal wire; 42, second metal wire; 43, first mesh; 5, second mesh structure; 51, third metal wire; 52, fourth metal wire. DETAILED DESCRIPTION

[0039] In order to make the purpose, technical scheme and advantages of the present application more clear and obvious, the present application is further described in detail below in combination with specific embodiments.

[0040] It should be noted that, unless otherwise defined, the technical terms or scientific terms used in the present application should be understood as the usual meanings by those skilled in the art. The terms "first", "second" and similar words used in the present application do not represent any order, quantity or importance, but are only used to distinguish different components. The terms "include" or "contain" and similar words mean that the elements or objects before the words cover the elements or objects listed after the words and their equivalents, without excluding other elements or objects. The terms "connect" or "connected" and similar words are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect. The terms "up", "down", "left", "right" and the like are only used to represent relative positional relationships, and when the absolute positions of the described objects change, the relative positional relationships may also change accordingly. The terms "proximal" and "distal" are the relative positions, directions and orientations of the elements or actions with respect to each other from the perspective of the operator using the medical device, although "proximal" and "distal" are not limited, but "proximal" generally refers to the end of the medical device that is closest to the operator during normal operation, and "distal" generally refers to the end that enters the patient's body first.

[0041] Please refer to Figures 1 to 12The application provides a technical solution: an intratumoral embolism device, comprising an intratumoral embolism device body 1 woven by metal wires, the intratumoral embolism device body 1 comprises a first mesh structure 4 and a second mesh structure 5 which are attached to each other and do not interweave, the first mesh structure 4 comprises a first metal wire 41 and a second metal wire 42, the first metal wire 41 and the second metal wire 42 are interwoven to form a plurality of first meshes 43, the second mesh structure 5 comprises a third metal wire 51 and a fourth metal wire 52, the third metal wire 51 and the fourth metal wire 52 are interwoven to form a second mesh, the first metal wire 41 and the second metal wire 42 on the first mesh structure 4 do not interweave the third metal wire 51 and the fourth metal wire 52 on the second mesh structure 5.

[0042] The intratumoral embolism device body 1 is provided with a top portion 11, a middle portion 12 and a bottom portion 13, the first mesh structure 4 and the second mesh structure 5 are integrally connected at the top portion 11 of the intratumoral embolism device body 1 to form a smooth transition connecting portion 111, and are fixedly connected together at the bottom portion 13 of the intratumoral embolism device body 1.

[0043] The arrangement of the first metal wire 41 and the second metal wire 42 on the first mesh structure 4 is different from the arrangement of the third metal wire 51 and the fourth metal wire 52 on the second mesh structure, so that the first metal wire 41 and the second metal wire 42 on the first mesh structure 4 are staggered and do not completely overlap the third metal wire 51 and the fourth metal wire 52 on the second mesh structure 5, and the first mesh 43 and the second mesh are staggered and do not completely overlap.

[0044] In this way, the application designs the arrangement of the first metal wire 41 and the second metal wire 42 on the first mesh structure 4 to be different from the arrangement of the third metal wire 51 and the fourth metal wire 52 on the second mesh structure 5, so that the metal wires and the meshes between the layers integrally connected at the top portion are staggered and do not completely overlap, thereby significantly increasing the mesh density without increasing the number of layers or the amount of metal wires, and at the same time, without increasing the supporting force, the intratumoral embolism device can balance high mesh density and appropriate supporting force under the condition of fewer layers and fewer metal wires per layer, thereby guaranteeing the slowing effect of blood flow impact and the retention effect of intratumoral blood flow, and at the same time, without increasing the supporting force of the embolism device to avoid stimulating the inner wall of the aneurysm.

[0045] The top portion 11 of the intratumoral embolism device body 1 is integrally connected by the first mesh structure 4 and the second mesh structure 5 to form a connecting portion 111, the connecting portion 111 is smoothly processed to be a whole with the first mesh structure 4 and the second mesh structure 5, that is, the first mesh structure 4 and the second mesh structure 5 are connected at the top portion position by the metal wires themselves, so that the top portion 11 has no irregular shapes such as welding points and protrusions, thereby avoiding the edge of the top portion 11 from stimulating and damaging the aneurysm wall.

[0046] The second mesh structure 5 is wrapped outside the first mesh structure 4, and the first mesh structure 4 is fixedly connected with the bottom 13 of the second mesh structure 5, is attached at the middle part 12, and is integrally arranged at the top 11, so that the first mesh structure 4 and the second mesh structure 5 will not be separated due to the impact of blood flow, and the separation between the first mesh structure 4 and the second mesh structure 5 avoids the formation of a cavity between the first mesh structure 4 and the second mesh structure 5 to form a thrombus, because the formed cavity will retain blood to form a free thrombus, which will seriously affect the health of the patient.

[0047] The first metal wire 41, the second metal wire 42, the third metal wire 51 and the fourth metal wire 52 are all shape memory materials with good elasticity and shape memory ability, and preferably, the metal wires are nickel-titanium wires. The intrasaccular embolus body 1 has a self-expanding function, and thus has a compressed and contracted state and an expanded and deployed state, that is, the intrasaccular embolus 1 is deformed into a contracted state under the action of an external load, and after the external load is removed, the intrasaccular embolus 1 spontaneously recovers to an initial shape to become a deployed state. In the process of delivering and deploying the intrasaccular embolus, the intrasaccular embolus body 1 is compressed by an external load to achieve delivery when being delivered, and is released after entering the aneurysm, that is, after the external load is removed, the intrasaccular embolus body 1 spontaneously recovers to the initial shape to generate a self-expanding force to achieve occlusion of the aneurysm orifice.

[0048] As an embodiment of the present application, as shown in Figure 4 and Figure 6 and Figure 7 As shown, the intrasaccular embolus body 1 is in a funnel-shaped arrangement when deployed, and the size relationship of the top 11, the middle part 12 and the bottom 13 of the intrasaccular embolus body 1 is D1>D2>D3, wherein D1 is the size of the top 11, D2 is the size of the middle part 12, and D3 is the size of the bottom 13. Preferably, the diameter of the intrasaccular embolus body 1 gradually decreases from the top 11 to the middle part 12, and the bottom 13 protrudes from the middle part 12. The intrasaccular embolus body 1 is suitable for intracranial arterial bifurcation wide-necked aneurysms, and in the process of implanting the aneurysm, the top 11 is first released to expand and contact the aneurysm wall, and the intrasaccular embolus body 1 is anchored in the aneurysm through the self-expanding force of the intrasaccular embolus body 1 and the friction force with the aneurysm; the middle part 12 will cover and occlude the aneurysm orifice after being released, and slow down the impact of blood on the aneurysm through the fine mesh on the intrasaccular embolus body 1; and the protruding shape of the bottom 13 can divert blood and guide it to normal blood vessels.

[0049] The middle part 12 of the intratumoral embolization device body 1 comprises a first curved surface 121 and a second curved surface 122, both of which are arc-shaped curved surfaces with different bending directions, the first curved surface 121 is closer to the bottom part 13 relative to the second curved surface 122, the first curved surface 121 is concave to the direction of blood flow impact, the bending radius of the first curved surface 121 is T1, the second curved surface 122 is convex to the direction of blood flow impact, the bending radius of the second curved surface 122 is T2, the first curved surface 121 is connected with the second curved surface 122 and the transition therebetween is smooth, the relationship between the bending radii of the first curved surface 121 and the second curved surface 122 satisfies T1 < T2, since the intratumoral embolization device body 1 will be pulled and stretched during implantation into an aneurysm, the deformation amount of the bottom part 13 is relatively small and the deformation amount of the middle part 12 is relatively large, so that under the action of the aneurysm, the first curved surface 121 and the second curved surface 122 are deformed to have bending radii close to each other, so that after complete implantation, the blood flow can flow more gently to the branch blood vessels, this design can reduce the impact force of the blood flow on the intratumoral embolization device and the aneurysm neck, so as to ensure that the intratumoral embolization device will not be displaced and deformed under the impact of the blood flow for a long time, since the blood flow is shunted and guided to the normal blood vessels, platelets cannot be aggregated in large quantities at the aneurysm neck, the risk of free thrombus formation is significantly reduced, the health of the patient is protected, and the intratumoral embolization device body 1 can be further provided with an anticoagulant coating, such as a fibrin coating, to further reduce the risk of thrombus formation.

[0050] The application also provides an intratumoral embolization device, comprising an intratumoral embolization device and a delivery system for delivering and deploying the intratumoral embolization device, the delivery system comprising a delivery device 2 and a release wire 3, the delivery device 2 being an elongated rod-shaped structure, the distal end of the delivery device 2 being connected with the intratumoral embolization device body 1 through the release wire 3, and the delivery device 2 delivering and implanting the intratumoral embolization device body 1 into an aneurysm. The delivery system delivers the intratumoral embolization device into the aneurysm and deploys the intratumoral embolization device in the aneurysm, and after completing the deployment, the release wire is broken by energization to achieve the release of the intratumoral embolization device.

[0051] As an embodiment of the application, the bottom part 13 of the intratumoral embolization device body 1 is provided with a cylindrical hollow collar 14, the collar 14 is sleeved on the outside of the bottom part 13, and the metal wires of the bottom part 13 all pass through the inner cavity of the collar 14 and are fixed therein. The fixing mode between the bottom part 13 of the intratumoral embolization device body 1 and the collar 14 is pressure welding, welding and adhesion, etc. Further, the collar 14 protrudes from the middle part 12 in the direction away from the top part 11 in the axial direction of the intratumoral embolization device body 1, the end away from the intratumoral embolization device body 1 is provided with a hemispherical shape and a smooth surface, which is beneficial to enhance the diversion of the blood flow impacting the bottom of the intratumoral embolization device body 1 to the side, the collar 14 is connected with the release wire 3, the proximal end of the release wire 3 is connected with the delivery device 2, and the diameter of the release wire 3 is smaller than that of the delivery device 2.

[0052] The loop 14, the first curved surface 121 and the second curved surface 122 guide the blood flow to be shunted, thereby reducing the impact force of the blood flow on the aneurysm neck and the intrasaccular embolization device. The blood flow impacting the aneurysm is shunted to both sides after contacting the loop 14, and then contacts the first curved surface 121 of the intrasaccular embolization device 1. Since the first curved surface 121 is concave to the direction of the blood flow impact, the flow rate of the blood is reduced and the impact force is significantly weakened under the influence of the surface mesh of the intrasaccular embolization device 1. When the blood flow continues to flow to the second curved surface 122, the direction of the blood flow will be guided and changed under the influence of the convex shape of the second curved surface 122, and flow to the normal branch vessels on both sides. By the arrangement of the loop 14, the first curved surface 121 and the second curved surface 122, the impact force of the blood flow on the aneurysm neck and the intrasaccular embolization device can be reduced, and the intrasaccular embolization device can be prevented from being displaced and deformed under the impact of the blood flow for a long time. At the same time, the blood flow is shunted and guided to flow to the normal vessels, and the platelets cannot be aggregated in large quantities at the aneurysm neck, thereby significantly reducing the risk of free thrombus formation and protecting the health of the patient.

[0053] In addition, the intrasaccular embolization device can also be provided with an anticoagulant coating, such as a fibrin coating, to further reduce the risk of thrombus formation.

[0054] As Figure 8As shown, the first mesh structure 4 and the second mesh structure 5 have the same size to ensure that the first mesh structure 4 and the second mesh structure 5 integrally connected at the top 11 can converge together at the bottom 13 to realize fixed connection. The first mesh structure 4 and the second mesh structure 5 are both formed by interlacing a plurality of arc-shaped wires, the first wire 41, the second wire 42, the third wire 51 and the fourth wire 52 are all shape memory materials, one end of the first wire 41, the second wire 42, the third wire 51 and the fourth wire 52 converges at the bottom 13 of the intrasaccular embolus main body 1, and the other end diverges towards the top 11. The first wire 41 and the second wire 42 are uniformly arranged on the first mesh structure 4 in a circle, the wires of the intrasaccular embolus main body 1 are divided into clockwise wires and counterclockwise wires according to the direction, wherein the first wire 41 and the third wire 51 are clockwise wires, and the second wire 42 and the fourth wire 52 are counterclockwise wires, the first wire 41 and the second wire 42 interlaced to form a first mesh 43 approximately in the shape of a rhombus, the first wire 41 and the second wire 42 are connected to form a closed loop at the top 11, the third wire 51 and the fourth wire 52 are uniformly arranged on the second mesh structure 5, the third wire 51 and the fourth wire 52 interlaced to form a second mesh approximately in the shape of a rhombus, the third wire 51 and the fourth wire 52 are connected to form a closed loop at the top 11, the area of the first mesh 43 and the second mesh gradually decreases from the top 11 to the bottom 13, so that the mesh at the bottom 13 of the intrasaccular embolus main body 1 is small and has high density, which significantly reduces the impact of blood flow on the aneurysm and enhances the plugging effect, while the mesh at the top 11 of the intrasaccular embolus main body 1 is larger and the outer side is relatively smooth, which is less damaging and stimulating to the aneurysm wall when in contact with the aneurysm wall, and is safer after being implanted into the aneurysm.

[0055] The number of the first wire 41 and the second wire 42 is the same, and the number of the third wire 51 and the fourth wire 52 is the same.

[0056] The number of the first wire 41 and the second wire 42 on the first mesh structure 4 is the same as the number of the third wire 51 and the fourth wire 52 on the second mesh structure 5. The wire diameter of the first wire 41 and the second wire 42 on the first mesh structure 4 is the same as the wire diameter of the third wire 51 and the fourth wire 52 on the second mesh structure 5. The first mesh structure and the second mesh structure integrally connected at the top are woven by wires with the same number of braids and the same wire diameter, which on the one hand avoids the stimulation of the broken end part caused by different numbers of braids to the aneurysm, and the radial support force is basically the same to ensure the adhesion of the layers, and on the other hand the processing technology is simple, the requirements for the wires are relatively low, which avoids the increase of the material cost and processing cost of the intrasaccular embolus main body.

[0057] As an embodiment of the present application, asFigure 9 As shown in the top view, the deflection angles of the first metal wires 41 and the second metal wires 42 on the first mesh structure 4 and the deflection angles of the third metal wires 51 and the fourth metal wires 52 on the second mesh structure 5 are different, so that the arrangement of the first metal wires 41 and the second metal wires 42 on the first mesh structure 4 is different from the arrangement of the third metal wires 51 and the fourth metal wires 52 on the second mesh structure, so as to realize the incomplete overlap of the metal wires and the mesh between the layers. Figure 10 As shown in the top view, the deflection angles of the first metal wires 41 and the second metal wires 42 on the first mesh structure 4 and the deflection angles of the third metal wires 51 and the fourth metal wires 52 on the second mesh structure 5 are different, so that the arrangement of the first metal wires 41 and the second metal wires 42 on the first mesh structure 4 is different from the arrangement of the third metal wires 51 and the fourth metal wires 52 on the second mesh structure, so as to realize the incomplete overlap of the metal wires and the mesh between the layers.

[0058] Embodiment one: as shown in Figure 9 The deflection phase angles of the metal wires of the first mesh structure 4 and the second mesh structure 5 are different, and in the top view, the deflection angles of the first metal wires 41 and the second metal wires 42 are α1, and the deflection angles of the third metal wires 51 and the fourth metal wires 52 are α2, α1≠α2. Figure 9 The deflection angles of the first metal wires 41 and the second metal wires 42 are α1, and the deflection angles of the third metal wires 51 and the fourth metal wires 52 are α2, α1≠α2.

[0059] Further, the relationship between the deflection angles satisfies: Wherein the total number of the first metal wires 41 and the second metal wires 42 is n, the total number of the first metal wires 41 and the second metal wires 42 is equal to the total number of the third metal wires 51 and the fourth metal wires 52, and k is any integer. This arrangement is conducive to ensuring that the first metal wires 41 and the second metal wires 42 of the first mesh structure 4 do not completely overlap the third metal wires 51 and the fourth metal wires 52 of the second mesh structure 5 after overlapping, and the mesh of the second mesh structure 5 will further divide the mesh of the first mesh structure 4, so that the grid density increases several times under the condition that the number of layers of the intratumoral embolism device body 1 remains unchanged, thereby enhancing the blocking effect of the intratumoral embolism device body 1.

[0060] The deflection angles of the metal wires of the first mesh structure and the second mesh structure can be interchanged, as long as the metal wires and the mesh of the first mesh structure and the second mesh structure can be incompletely overlapped.

[0061] Embodiment two: different from the metal wire arrangement of embodiment one, as shown in Figure 10 and Figure 11 As shown inFigure 10 From a top-down perspective, the bending radii of the metal wires in the first mesh structure 4 and the second mesh structure 5 are different. In the first mesh structure 4, the bending radius of the first metal wire 41 and the second metal wire 42 is both R1, while in the second mesh structure 5, the bending radius of the third metal wire 51 and the fourth metal wire 52 is both R2. The relationship between the bending radii satisfies: R1 ≠ R2. This arrangement allows the use of metal wires with smaller bending radii to divide the mesh formed by metal wires with larger bending radii into more numerous and smaller meshes. This results in a several-fold increase in mesh density while maintaining the same number of layers in the aneurysm embolization device body 1, significantly enhancing the occlusion effect on the aneurysm.

[0062] Example 3: Figure 12 As shown, the number of mesh structure layers of the intraneural embolizer body 1 is C>2. When the number of layers C of the intraneural embolizer body 1 is even, the Xth layer is connected to the Xth layer from the end, X=1;2;3;4;5... until all metal meshes are connected, and other metal meshes N are wrapped layer by layer in sequence. This method is suitable for use on different types of aneurysms.

[0063] In this embodiment, the preferred number of layers c of the intra-aneurysmal embolizer is 2 ≤ c ≤ 4. Within this range, the intra-aneurysmal embolizer can achieve both good occlusion and moderate self-expansion force. More preferably, an even number of layers is selected. The more layers the intra-aneurysmal embolizer body 1 has, the finer the mesh on the surface of the body 1, resulting in a stronger effect in mitigating blood flow impact and a better occlusion effect on the aneurysm. However, the more layers there are, the stronger the self-expansion force of the body 1 will be. Since the self-expansion force of the body 1 acts directly on the aneurysm wall, which is relatively thin, excessive expansion force will increase the risk of aneurysm rupture.

[0064] Specifically, as another embodiment, the intratumoral embolization device body 1 also includes a third mesh structure and a fourth mesh structure that are attached to each other but not intertwined. The third mesh structure and the fourth mesh structure are integrally connected at the top 11 of the intratumoral embolization device body 1 and converge and are fixedly connected at the bottom 13. The third mesh structure and the fourth mesh structure are wrapped between the first mesh structure 4 and the second mesh structure 5. The outline size of the third mesh structure and the fourth mesh structure is the same as the outline size of the first mesh structure 4 and the second mesh structure 5. The metal wires of the first mesh structure 4, the second mesh structure 5, the third mesh structure and the fourth mesh structure are arranged differently, so that the metal wires on the first mesh structure 4, the second mesh structure 5, the third mesh structure and the fourth mesh structure are staggered and do not completely overlap.

[0065] As one of the embodiments, the deflection angle a3 of the wire on the third mesh structure is different from the deflection angle a4 of the wire on the fourth mesh structure, and the deflection angle of the wire on the third mesh structure is different from the deflection angle of the wire on the first mesh structure and the deflection angle of the wire on the second mesh structure, and the deflection angle of the wire on the fourth mesh structure is different from the deflection angle of the wire on the first mesh structure and the deflection angle of the wire on the second mesh structure.

[0066] Further, the deflection angle a3 of the wire on the third mesh structure and the deflection angle a4 of the wire on the fourth mesh structure satisfy: wherein the total number of the wires of the third mesh structure and the fourth mesh structure is n, and k is an arbitrary integer.

[0067] When the total number of the wires of the third mesh structure and the fourth mesh structure is set to be the same as that of the first mesh structure and the second mesh structure, the above formula can also be satisfied between the two mesh structures.

[0068] As another embodiment, the bending radius of the wire on the third mesh structure is different from the bending radius of the wire on the fourth mesh structure, and the bending radius of the wire on the third mesh structure is different from the bending radius of the wire on the first mesh structure and the bending radius of the wire on the second mesh structure, and the bending radius of the wire on the fourth mesh structure is different from the bending radius of the wire on the first mesh structure and the bending radius of the wire on the second mesh structure.

[0069] It should be understood by those skilled in the art that the above discussion of any of the embodiments is only exemplary and is not intended to imply that the scope (including claims) of the present application is limited to these examples; under the idea of the present application, the above embodiments or technical features among different embodiments can also be combined, the steps can be implemented in any order, and there are many other changes of different aspects of the present application as described above, which are not provided in details for the sake of brevity.

[0070] The present application is intended to cover all such alternatives, modifications and variations as fall within the broad scope of the appended claims. Accordingly, any and all such modifications, variations or equivalents that fall within the spirit and scope of the application are intended to be included within the scope of the application.

Claims

1. An intratumoral embolizer, comprising an intratumoral embolizer body (1) woven by interlacing metal wires, characterized in that: The intratumoral embolizer body (1) includes a first mesh structure (4) and a second mesh structure (5) that are mutually adhered and do not interweave with each other; the first mesh structure (4) further includes a first metal wire (41) and a second metal wire (42), and the first metal wire (41) and the second metal wire (42) are interlaced to form a plurality of first meshes (43); the second mesh structure (5) includes a third metal wire (51) and a fourth metal wire (52), and the third metal wire (51) and the fourth metal wire (52) are interlaced to form a second mesh; the first metal wire (41) and the second metal wire (42) on the first mesh structure (4) do not interweave with the third metal wire (51) and the fourth metal wire (52) on the second mesh structure (5); The intratumoral embolizer body (1) is provided with a top (11), a middle part (12) and a bottom (13). The first mesh structure (4) and the second mesh structure (5) are integrally connected at the top (11) of the intratumoral embolizer body (1) to form a smoothly transitioning connecting part (111), and converge and are fixedly connected at the bottom (13) of the intratumoral embolizer body (1); The arrangement of the first metal wire (41) and the second metal wire (42) on the first mesh structure (4) is different from the arrangement of the third metal wire (51) and the fourth metal wire (52) on the second mesh structure, so that the first metal wire (41) and the second metal wire (42) on the first mesh structure (4) are staggered and do not completely overlap the third metal wire (51) and the fourth metal wire (52) on the second mesh structure (5), and the first mesh (43) and the second mesh are staggered and do not completely overlap.

2. The intratumoral embolization device according to claim 1, characterized in that, When the intratumoral embolizer body (1) is deployed, it is arranged in a funnel shape, and the size relationship of the top (11), the middle part (12) and the bottom (13) of the intratumoral embolizer body (1) is D1 > D2 > D3, where D1 is the size of the top (11), D2 is the size of the middle part (12), and D3 is the size of the bottom (13).

3. The intratumoral embolization device according to claim 2, characterized in that, The middle part (12) of the intratumoral embolizer body (1) includes a first curved surface (121) and a second curved surface (122). Both the first curved surface (121) and the second curved surface (122) are arc-shaped curved surfaces and have different bending directions. The first curved surface (121) is closer to the bottom (13) relative to the second curved surface (122). The first curved surface (121) is concave in the direction of blood flow impact, and the bending radius of the first curved surface (121) is T1. The second curved surface (122) is convex in the direction of blood flow impact, and the bending radius of the second curved surface (122) is T2. The bending radius T1 and the bending radius T2 satisfy T1 < T2. The first curved surface (121) and the second curved surface (122) are connected and the transition between them is smooth.

4. The intratumoral embolization device according to claim 2, characterized in that, The first mesh structure (4) and the second mesh structure (5) have the same outline size. Both the first mesh structure (4) and the second mesh structure (5) are formed by several interlaced arc-shaped metal wires. The first metal wire (41), the second metal wire (42), the third metal wire (51) and the fourth metal wire (52) are all shape memory materials. One end of the first metal wire (41), the second metal wire (42), the third metal wire (51) and the fourth metal wire (52) converge at the bottom (13) of the tumor embolization device body (1), and the other end faces the top (11). The first metal wire (41) and the third metal wire (51) are clockwise metal wires, and the second metal wire (42) and the fourth metal wire (52) are counterclockwise metal wires. The first metal wire (41) and the second metal wire (42) are connected at the top (11) to form a closed loop, and the third metal wire (51) and the fourth metal wire (52) are connected at the top (11) to form a closed loop. The area of ​​the first grid (43) and the second grid gradually decreases from the top (11) to the bottom (13).

5. The intratumoral embolization device according to claim 1, characterized in that, The first metal wire (41) and the second metal wire (42) deflect at an angle of α1 relative to the horizontal line, and the third metal wire (51) and the fourth metal wire (52) deflect at an angle of α2 relative to the horizontal line, wherein α1 ≠ α2.

6. The intratumoral embolization device according to claim 5, characterized in that, The relationship between the deflection angles α1 and α2 satisfies: The total number of the first metal wire (41) and the second metal wire (42) is n, and the total number of the first metal wire (41) and the second metal wire (42) is equal to the total number of the third metal wire (51) and the fourth metal wire (52). k is any integer.

7. The intratumoral embolization device according to claim 1, characterized in that, In the first mesh structure (4), the bending radius of the first metal wire (41) and the second metal wire (42) is R1, and in the second mesh structure (5), the bending radius of the third metal wire (51) and the fourth metal wire (52) is R2. The relationship between the bending radii satisfies: R1≠R2.

8. The intratumoral embolization device according to claim 1, characterized in that, The number of mesh structure layers of the main body (1) of the tumor embolizer is C, where C satisfies C≥2 and is an even number. The Xth layer is connected to the Xth layer from the end (X=1; 2; 3; 4; 5...) until all metal meshes are connected, and other metal meshes N are wrapped layer by layer in turn.

9. The intratumoral embolization device according to claim 1, characterized in that, The main body (1) of the intratumoral embolizer also includes a third mesh structure and a fourth mesh structure that are attached to each other but not intertwined. The third mesh structure and the fourth mesh structure are integrally connected at the top (11) of the main body (1) of the intratumoral embolizer and converge and are fixedly connected at the bottom (13). The third mesh structure and the fourth mesh structure are wrapped between the first mesh structure (4) and the second mesh structure (5). The outline size of the third mesh structure and the fourth mesh structure is the same as the outline size of the first mesh structure (4) and the second mesh structure (5). The metal wires of the first mesh structure (4), the second mesh structure (5), the third mesh structure and the fourth mesh structure are arranged differently, so that the metal wires on the first mesh structure (4), the metal wires on the second mesh structure (5), the metal wires on the third mesh structure and the metal wires on the fourth mesh structure are staggered and do not completely overlap.

10. An intratumoral embolization device, characterized in that, Includes the intratumoral embolizer as described in any one of claims 1-9 and a delivery system for delivering and deploying the intratumoral embolizer; The delivery system includes a delivery device (2) and a release wire (3). The delivery device (2) is a slender rod-shaped structure. The distal end of the delivery device (2) is connected to the body (1) of the intraneural embolizer via the release wire (3). The delivery device (2) is used to deliver the intraneural embolizer (1) and implant it into the aneurysm. After the intraneural embolizer is deployed, the release wire (3) breaks to release the intraneural embolizer.

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