Intratumoral embolism device and intratumoral embolism device with same

Abstract

The invention relates to the technical field of medical instruments, in particular to an intratumoral embolism device which comprises an intratumoral embolism device body with at least two layers of net structures, the net structures are formed by weaving metal wires in a staggered mode, and the intratumoral embolism device body comprises a first net structure and a second net structure which are not interwoven. The arrangement of the metal wires on the first net-shaped structure is designed to be different from the arrangement of the metal wires on the second net-shaped structure, so that the metal wires of the first net-shaped structure and the second net-shaped structure are staggered and are not completely overlapped, and the first net-shaped structure and the second net-shaped structure are overlapped; the first metal wires and the second metal wires of the first net-shaped structure are not completely overlapped with the third metal wires and the fourth metal wires of the second net-shaped structure, the grids of the second net-shaped structure can divide the grids of the first net-shaped structure to be finer, the grid density is increased by several times, and then the blocking effect of the intra-tumor embolism device body is enhanced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and in particular to an intratumor embolization device and an intratumor embolization apparatus having the same. Background Art

[0002] Intracranial aneurysms are pathological expansions caused by long-term impact of unstable blood flow in weak areas of intracranial blood vessel walls. They are characterized by high morbidity, high disability and high mortality, and seriously endanger the life and health of patients. Wide-necked aneurysms at the bifurcation of intracranial arteries are difficult to treat with interventional therapy because of the large vascular branches that emanate from the vicinity of the neck of the aneurysm. Wide-necked aneurysms at the bifurcation involve multiple branches, so traditional treatment methods are relatively complicated. Stent-assisted coil embolization and blood flow guidance devices are difficult to overcome this problem. In recent years, intratumoral embolization devices have emerged that can interfere with the blood flow at the neck of the aneurysm and enter the aneurysm, overcoming the shortcomings of traditional devices. After the intratumoral embolizer is implanted into the aneurysm, the mesh structure will block the aneurysm neck. When blood flows to the aneurysm, the blood flow rate will be greatly reduced under the obstruction of the mesh structure of the intratumoral embolizer, weakening the impact of blood flow on the aneurysm. The blood flow flowing into the aneurysm will also be blocked by the mesh structure and stay in the aneurysm for a long time until an intratumoral thrombus is formed, completing the closure of the aneurysm.

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

[0004] However, existing intratumoral embolic devices also have some shortcomings. For example, the mesh density of the intratumoral embolic device at the neck of the aneurysm is relatively small, the effect of reducing the impact force of blood flow is poor, the retention effect of blood in the aneurysm is not obvious enough, and the blocking effect is poor. The conventional way to increase the mesh density of the intratumoral embolic device is to increase the amount of metal wire, weave the mesh area smaller, or stack more layers. The disadvantage of this is that it will significantly increase the overall supporting force of the intratumoral embolic device, and the increase in supporting force will increase the pressure exerted by the intratumoral embolic device on the aneurysm wall. The aneurysm wall is relatively weak and prone to serious injuries such as rupture.

[0005] To this end, an intratumor embolization device and an intratumor embolization apparatus having the same are proposed. Summary of the invention

[0006] The purpose 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 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 woven by metal wires in a staggered manner, the intratumoral embolizer main body includes a first mesh structure and a second mesh structure that are mutually attached 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 woven in a staggered manner 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 woven in a staggered manner 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. 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 transitioning connecting part, and converge and are fixedly connected at the bottom of the intratumoral embolizer main body. 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.

[0008] Preferably, when the intratumoral embolizer main body is deployed, it is arranged in a funnel shape, and the size relationship of the top, middle part and 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.

[0009] 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, and the bending radius of the first curved surface is T1. The second curved surface is convex in the direction of blood flow impact, and the bending radius of the second curved surface is T2. 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.

[0010] Preferably, the first mesh structure and the second mesh structure have the same outline size, the first mesh structure and the second mesh structure are uniformly formed by interlacing a plurality of arc-shaped metal wires, the first metal wire, the second metal wire, the third metal wire and the fourth metal wire are all made of shape memory materials, one end of the first metal wire, the second metal wire, the third metal wire and the fourth metal wire converge at the bottom of the intratumor embolizer body, the other end of the first metal wire diverges toward the top, and is uniformly arranged in a circle on the first mesh structure, the first metal wire and the third metal wire are clockwise metal wires, the second metal wire and the fourth metal wire are counterclockwise metal wires, the two ends of the first metal wire and the second metal wire are respectively connected at the top and the bottom to form a closed loop, the third metal wire and the fourth metal wire are connected at the top to form a closed loop, and the areas of the first grid and the second grid gradually decrease from the top to the bottom.

[0011] Preferably, the deflection angles of the first metal wire and the second metal wire with respect to the horizontal line are α1, and the deflection angles of the third metal wire and the fourth metal wire with respect to the horizontal line are α2, and α1≠α2.

[0012] Preferably, the relationship between the deflection angles α1 and α2 satisfies: , wherein the total number of the first metal wires and the second metal wires is n, the total number of the first metal wires and the second metal wires is equal to the total number of the third metal wires and the fourth metal wires, and k is an arbitrary integer.

[0013] Preferably, the bending radii of the first metal wire and the second metal wire in the first mesh structure are both R1, and the bending radii of the third metal wire and the fourth metal wire in the second mesh structure are both R2, and the relationship between the bending radii satisfies: R1≠R2.

[0014] Preferably, the number of mesh structure layers of the intratumor embolizer body is C, C satisfies C≥2 and is an even number, the Xth layer is connected to the Xth last layer (X=1; 2; 3; 4; 5...), until all metal meshes are connected, and other metal meshes N are wrapped layer by layer in sequence.

[0015] Preferably, the intratumor embolizer body further comprises a third mesh structure and a fourth mesh structure which fit each other but are not intertwined with each other, the third mesh structure and the fourth mesh structure are integrally connected at the top of the intratumor embolizer body, converge together and are fixedly connected at the bottom, the third mesh structure and the fourth mesh structure are wrapped between the first mesh structure and the second mesh structure, 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 and the second mesh structure, the first mesh structure, the second mesh structure, the third mesh structure and the fourth mesh structure are arranged differently, 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 do not completely overlap.

[0016] The present invention also provides: an intratumor embolization device, comprising any one of the intratumor embolization devices described above and a delivery system for delivering and deploying the intratumor embolization device; The delivery system includes a delivery device and a release wire. The delivery device is a slender rod-shaped structure. The distal end of the delivery device is connected to the intratumoral embolizer body through the release wire. The delivery device is used to deliver and implant the intratumoral embolizer into the aneurysm. After the intratumoral embolizer is deployed, the release of the intratumoral embolizer is achieved by the breaking of the release wire.

[0017] Beneficial effects of the present invention: 1. The present invention designs the metal wires of the first mesh structure and the second mesh structure to have different deflection phase angles, which is beneficial to ensure that after the first mesh structure and the second mesh structure overlap, the first metal wires and the second metal wires of the first mesh structure do not completely overlap the third metal wires and the fourth metal wires of the second mesh structure, and the meshes of the second mesh structure divide the meshes of the first mesh structure into smaller parts, so that the mesh density increases several times while the number of layers of the main body of the intratumor embolizer remains unchanged, thereby enhancing the blocking effect of the main body of the intratumor embolizer.

[0018] 2. The present invention designs the bending radii of the metal wires of the first mesh structure and the second mesh structure to be different, which is conducive to using the metal wires with smaller bending radius to divide the mesh formed by the metal wires with larger bending radius into more meshes with smaller areas, so that the mesh density is increased several times while the number of layers of the main body of the intra-tumor embolizer remains unchanged, thereby significantly enhancing the blocking effect on the aneurysm.

[0019] 3. The present invention increases the number of different layers of the mesh structure of the intratumoral embolizer body by design, which is beneficial to enhancing the grid density on the surface of the intratumoral embolizer body, and has a stronger effect of mitigating blood flow impact, and a better effect of blocking and embolizing the aneurysm. It is suitable for different types of aneurysms. However, the more layers there are, the stronger the self-expansion force of the intratumoral embolizer body will be. Since the self-expansion force of the intratumoral embolizer body directly acts on the aneurysm wall, the aneurysm wall is relatively weak, and excessive expansion force will increase the risk of aneurysm rupture. Therefore, the optimal number of layers C of the intratumoral embolizer body for wide-necked aneurysms in the bifurcation of intracranial arteries in the present invention is in the range of 2≤C≤4, and the optimal number of layers is an even number of layers. Within this range of layers, the intratumoral embolizer can take into account both good blocking effect and moderate self-expansion force.

[0020] 4. The present invention designs different sizes of the top, middle and bottom parts so that the blood flow of the intratumoral embolizer body can flow more smoothly to the branch blood vessels after it is fully implanted. This design can reduce the impact force of blood flow on the intratumoral embolizer and the neck of the aneurysm, ensuring that the intratumoral embolizer will not be displaced or deformed under the impact of long-term blood flow. Since the blood flow is diverted and guided to flow to normal blood vessels, platelets at the neck of the aneurysm cannot aggregate in large quantities, which significantly reduces the risk of free thrombus formation and protects the health of patients. In addition, the areas of the first grid and the second grid are gradually reduced from the top to the bottom, so that the grid at the bottom of the intratumoral embolizer body is small and has a high density, which significantly reduces the impact of blood flow on the aneurysm and enhances the blocking effect. The grid at the top of the intratumoral embolizer body is larger and the outer side is smoother. When it contacts the aneurysm wall, it causes less damage and stimulation to the aneurysm wall, making it safer after implantation into the aneurysm. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions in the present invention or the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only for the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0022] Figure 1 It is a schematic diagram of the structure of the intratumor embolization device and the delivery system of the present invention; Figure 2 It is a schematic diagram of the structure of the intratumor embolization device of the present invention; Figure 3 For the present invention Figure 2 A schematic diagram of the structure of the intratumor embolizer shown from a top view; Figure 4 For the present invention Figure 2 Schematic cross-sectional view of the intratumoral embolization device; Figure 5 It is a schematic diagram of the structure of the intratumor embolization device and the delivery system of the present invention; Figure 6 It is a schematic diagram of the structure of the intra-tumor embolization device of the present invention being implanted into an aneurysm; Figure 7 It is a schematic diagram of the structure of the intratumor embolization device of the present invention after being implanted into an aneurysm; Figure 8 For the present invention Figure 2 A schematic diagram of the structure of the first mesh structure of the intratumoral embolizer from a top view; Fig. 9 It is a structural schematic diagram of a first mesh structure and a second mesh structure in accordance with a first embodiment of the present invention; Fig.10 This is a schematic structural diagram of a first mesh structure and a second mesh structure according to a second embodiment of the present invention; Fig.11 It is a schematic diagram of the structure after the first mesh structure and the second mesh structure are superimposed in the second embodiment of the present invention; Fig.12 This is a schematic diagram of a connection method in which the number of layers of the intratumor embolizer is 4 in Example 3 of the present invention.

[0023] Markings in the figure are: 1. intratumor embolizer body; 11. top; 111. connecting part; 12. middle part; 121. first curved surface; 122. second curved surface; 13. bottom; 14. loop; 2. delivery device; 3. release wire; 4. first mesh structure; 41. first metal wire; 42. second metal wire; 43. first grid; 5. second mesh structure; 51. third metal wire; 52. fourth metal wire. DETAILED DESCRIPTION

[0024] In order to make the objectives, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with specific embodiments.

[0025] It should be noted that, unless otherwise defined, the technical terms or scientific terms used in the present invention should be understood by people with ordinary skills in the field to which the present invention belongs. The words "first", "second" and similar words used in the present invention do not indicate any order, quantity or importance, but are only used to distinguish different components. "Include" or "comprise" and similar words mean that the elements or objects appearing before the word include the elements or objects listed after the word and their equivalents, without excluding other elements or objects. "Connect" or "connected" and similar words are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly. The terms "proximal" and "distal" refer to the relative orientation, position, and direction of components or actions relative to each other from the perspective of an operator using the medical device. Although "proximal" and "distal" are not restrictive, the "proximal" usually refers to the end of the medical device that is close to the operator during normal operation, and the "distal" usually refers to the end that first enters the patient's body.

[0026] See also Figures 1 to 12The present invention provides a technical solution: an intratumor embolizer, comprising an intratumor embolizer body 1 formed by interlacing metal wires, the intratumor embolizer body 1 comprising a first mesh structure 4 and a second mesh structure 5 which are attached to each other and not interlaced with each other, the first mesh structure 4 comprising a first metal wire 41 and a second metal wire 42, the first metal wire 41 and the second metal wire 42 are interlaced to form a plurality of first grids 43, the second mesh structure 5 comprising a third metal wire 51 and a fourth metal wire 52, the third metal wire 51 and the fourth metal wire 52 are interlaced to form a second grid, the first metal wire 41 and the second metal wire 42 on the first mesh structure 4 are not interlaced with the third metal wire 51 and the fourth metal wire 52 on the second mesh structure 5; The intratumor 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 intratumor embolizer body 1 to form a smoothly transitioned connecting part 111, and converge together and are fixedly connected at the bottom 13 of the intratumor 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 grid 43 and the second grid are staggered and do not completely overlap.

[0027] In this way, the present invention 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 meshes between the layers integrally connected at the top are staggered and do not completely overlap, thereby achieving a significant increase in mesh density without increasing the number of layers or the amount of metal wires used, and at the same time without increasing the supporting force, so that the intra-tumor embolizer has both high mesh density and appropriate supporting force with a smaller number of layers and a smaller number of metal wires in each layer, thereby ensuring the embolizer's effect of mitigating blood flow impact and retaining and blocking blood flow in the tumor without increasing the supporting force of the embolization device to avoid irritating the inner wall of the aneurysm.

[0028] The top 11 of the intratumor embolizer body 1 is formed by integrally connecting the first mesh structure 4 and the second mesh structure 5 to form a connecting portion 111, and the connecting portion 111 is smoothly transitioned to be integrated 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 position by their own metal wires, so that the top 11 has no irregular shapes such as welding points and protrusions, thereby preventing the edge of the top 11 from irritating and damaging the aneurysm wall.

[0029] The second mesh structure 5 is wrapped around the outside of the first mesh structure 4. The first mesh structure 4 and the second mesh structure 5 are fixedly connected at the bottom 13, the middle 12 is fitted, and the top 11 is integrally arranged, so that the first mesh structure 4 and the second mesh structure 5 will not be stratified due to the impact of blood flow, thereby avoiding the formation of cavities between the layers to form thrombi, because the formed cavities will retain blood to form free thrombi, which will seriously affect the health of patients.

[0030] The first metal wire 41, the second metal wire 42, the third metal wire 51 and the fourth metal wire 52 are all made of shape memory materials with good elasticity and shape memory ability. Preferably, the metal wire is nickel titanium wire. The main body 1 of the intratumoral embolizer has a self-expansion function, and thus has a compressed contracted state and an expanded expanded state, that is, the intratumoral embolizer 1 is deformed into a contracted state under the action of an external load, and can spontaneously restore its original shape to an expanded state after the external load is removed. In the process of transporting and deploying the intratumoral embolizer, the main body 1 of the intratumoral embolizer is compressed by the external load during transport to achieve transport, and is released after entering the aneurysm, that is, after the external load is removed, the main body 1 of the intratumoral embolizer will spontaneously restore its original shape and generate a self-expansion force to achieve occlusion of the aneurysm orifice.

[0031] As an embodiment of the present invention, Figure 4 and Figure 6 as well as Figure 7 As shown, the main body 1 of the intratumor embolizer is arranged in a funnel shape when unfolded, and the size relationship between the top 11, the middle part 12 and the bottom 13 of the main body 1 of the intratumor embolizer 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 main body 1 of the intratumor embolizer gradually decreases from the top 11 to the bottom middle part 12, and the bottom 13 protrudes from the middle part 12. The intratumoral embolizer body 1 is suitable for wide-necked aneurysms at the bifurcation of intracranial arteries. During the implantation of the intratumoral embolizer body 1 into the aneurysm, the top 11 is first released to expand and contact the aneurysm wall, and the intratumoral embolizer body 1 is anchored in the aneurysm through the self-expansion force of the intratumoral embolizer body 1 and the friction force with the aneurysm; the middle part 12 will cover and block the neck of the aneurysm after release, and the fine grid on the intratumoral embolizer body 1 will reduce the impact of blood on the aneurysm; the raised shape of the bottom 13 can divert the blood and guide it to normal blood vessels.

[0032] 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 with 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 first curved surface 121 is connected to the second curved surface 122 and the transition between them 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 embolizer body 1 will be pulled and extended during the implantation process in the aneurysm, the deformation amount of the bottom 13 is smaller and the deformation amount of the middle part 12 is larger. Under the action of the aneurysm, the first curved surface 121 and the second curved surface 122 are deformed until the bending radii tend to be close, so that the blood flow can flow more smoothly to the branch vessels after the intratumoral embolizer body 1 is completely implanted. This design can reduce the impact force of the blood flow on the intratumoral embolizer and the aneurysm neck opening, ensuring that the intratumoral embolizer will not shift and deform under the long-term blood flow impact. Since the blood flow is shunted and guided to flow to the normal blood vessels, platelets cannot accumulate in large amounts at the aneurysm neck opening, significantly reducing the risk of free thrombus formation and protecting the health of the patient. The intratumoral embolizer body 1 can also be provided with an anticoagulant coating, such as a fibrin coating, etc., to further reduce the risk of thrombus formation.

[0033] The present invention also provides an intratumoral embolization device, which includes an intratumoral embolizer and a delivery system for delivering and deploying the intratumoral embolizer. The delivery system includes a delivery device 2 and a detaching wire 3. The delivery device 2 is a slender rod-shaped structure. The distal end of the delivery device 2 is connected to the intratumoral embolizer body 1 through the detaching wire 3. The delivery device 2 delivers and implants the intratumoral embolizer body 1 into the aneurysm. The delivery system delivers the intratumoral embolizer into the aneurysm and deploys the intratumoral embolizer in the aneurysm. After the deployment is completed, the detaching wire is broken by electrifying to realize the detachment of the intratumoral embolizer.

[0034] As an embodiment of the present invention, a cylindrical hollow collar 14 is provided at the bottom 13 of the intratumoral embolizer body 1. The collar 14 is sleeved on the outside of the bottom 13, and all the metal wires of the bottom 13 pass through the inner cavity of the collar 14 and are fixed therein. The fixing method between the bottom 13 of the intratumoral embolizer body 1 and the collar 14 is crimping, welding, bonding, etc. Further, the collar 14 protrudes from the middle part 12 in the axial direction of the intratumoral embolizer body 1 in the direction away from the top 11, and the end away from the intratumoral embolizer body 1 is set to be hemispherical and the surface is smooth, which is beneficial to enhancing the diversion of the blood flow impacting the bottom of the intratumoral embolizer body 1 to the circumferential side. The collar 14 is connected with a detaching wire 3, the proximal end of the detaching wire 3 is connected to the delivery device 2, and the diameter of the detaching wire 3 is smaller than that of the delivery device 2.

[0035] The collar 14, the first curved surface 121 and the second curved surface 122 form a shunt guide for the blood flow, thereby reducing the impact force of the blood flow on the intratumoral embolizer and the neck of the aneurysm. After the blood flow impacting the aneurysm contacts the collar 14, it will be shunted to both sides, and then contact the first curved surface 121 of the intratumoral embolizer 1. Since the first curved surface 121 is concave in the direction of the blood flow impact, under the influence of the surface grid of the intratumoral embolizer 1, the blood flow rate will be reduced and the impact force will be significantly weakened. When the blood flow continues to flow to the second curved surface 122, under the influence of the convex shape of the second curved surface 122, the direction of the blood flow will be guided and changed, and flow to the normal branch vessels on both sides. The arrangement of the collar 14, the first curved surface 121 and the second curved surface 122 can reduce the impact force of the blood flow on the intratumoral embolizer and the neck of the aneurysm, ensuring that the intratumoral embolizer will not shift or deform under the impact of long-term blood flow. At the same time, blood flow is diverted and guided to normal blood vessels, and platelets at the tumor neck cannot aggregate in large numbers, significantly reducing the risk of free thrombus formation and protecting the patient's health.

[0036] In addition, the intratumoral embolizer can also be provided with an anticoagulant coating, such as a fibrin coating, to further reduce the risk of thrombosis.

[0037] like Figure 8As shown, the first mesh structure 4 and the second mesh structure 5 have the same outline size, so as 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 achieve fixed connection. The first mesh structure 4 and the second mesh structure 5 are uniformly formed by a plurality of arc-shaped metal wires interlaced, and the first metal wire 41, the second metal wire 42, the third metal wire 51 and the fourth metal wire 52 are all made of shape memory materials, and 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 intratumor embolizer body 1, and the other end diverges toward the top 11. The first metal wire 41 and the second metal wire 42 are evenly arranged in a circle on the first mesh structure 4. The metal wires of the intratumor embolizer body 1 are divided into clockwise metal wires and counterclockwise metal wires according to different directions. Among them, 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 interlaced with each other to form a first grid 43 that is approximately diamond-shaped. The first metal wire 41 and the second metal wire 42 are connected at the top 11 to form a closed loop. The third metal wire 51 and the fourth metal wire 52 are on the second mesh structure 5 The third metal wire 51 and the fourth metal wire 52 are evenly arranged, and are interlaced to form a second grid that is approximately diamond-shaped. The third metal wire 51 and the fourth metal wire 52 are connected at the top 11 to form a closed loop. The areas of the first grid 43 and the second grid gradually decrease from the top 11 to the bottom 13, so that the grid at the bottom 13 of the intratumoral embolizer body 1 is small and has a high density, which significantly reduces the impact of blood flow on the aneurysm and enhances the blocking effect. The grid at the top 11 of the intratumoral embolizer body 1 is larger and the outer side is smoother. When it contacts the aneurysm wall, it causes less damage and stimulation to the aneurysm wall, and is safer after being implanted into the aneurysm.

[0038] The number of the first metal wires 41 is the same as the number of the second metal wires 42 , and the number of the third metal wires 51 is the same as the number of the fourth metal wires 52 .

[0039] The number of braided strands of the first metal wire 41 and the second metal wire 42 on the first mesh structure 4 is the same as the number of braided strands of the third metal wire 51 and the fourth metal wire 52 on the second mesh structure 5. The wire diameters of the first metal wire 41 and the second metal wire 42 on the first mesh structure 4 are the same as the wire diameters of the third metal wire 51 and the fourth metal wire 52 on the second mesh structure 5. The first mesh structure and the second mesh structure connected at the top are braided with metal wires of the same number of braided strands and the same wire diameter. On the one hand, the stimulation of the aneurysm caused by the broken ends due to different numbers of braided strands is avoided, and the radial support force is basically the same to ensure the adhesion between the layers. On the other hand, the processing technology is simple and the requirements for the metal wire are relatively low, which avoids the increase of the main material cost and processing cost of the intra-tumor embolizer.

[0040] As an embodiment of the present invention, Fig. 9 In the top view shown, the deflection angle of the first metal wire 41 and the second metal wire 42 on the first mesh structure 4 and the horizontal line X is different from the deflection angle of the third metal wire 51 and the fourth metal wire 52 on the second mesh structure 5 and the horizontal line X, so that 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 as to achieve the staggered and incomplete overlap of the metal wires and meshes between layers. As another embodiment of the present invention, Fig.10 In the top view shown, the bending radius of the first metal wire 41 and the second metal wire 42 on the first mesh structure 4 is different from the bending radius of the third metal wire 51 and the fourth metal wire 52 on the second mesh structure 5, so that 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 as to achieve staggered and incomplete overlap of the metal wires and meshes between layers.

[0041] Embodiment 1: Fig. 9 As shown, the deflection phase angles of the metal wires of the first mesh structure 4 and the second mesh structure 5 are different. Fig. 9 In a top view, the deflection angle between the first metal wire 41 and the second metal wire 42 and the horizontal line X is α1, and the deflection angle between the third metal wire 51 and the fourth metal wire 52 and the horizontal line X is α2, and α1≠α2.

[0042] Furthermore, 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 an arbitrary integer. Such a setting is conducive to ensuring that after the first mesh structure 4 and the second mesh structure 5 overlap, 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, and the mesh of the second mesh structure 5 will divide the mesh of the first mesh structure 4 into smaller parts, so that the mesh density increases several times when the number of layers of the intratumor embolizer body 1 remains unchanged, thereby enhancing the blocking effect of the intratumor embolizer body 1.

[0043] The metal wire deflection angles of the first mesh structure and the second mesh structure can be interchanged, as long as the metal wires and grids of the first mesh structure and the second mesh structure do not completely overlap.

[0044] Embodiment 2: The arrangement of the metal wires is different from that of embodiment 1. Fig.10 and Fig.11 As shown, Fig.10 In the top view, the bending radius of the metal wires of the first mesh structure 4 and the second mesh structure 5 are different. The bending radius of the first metal wire 41 and the second metal wire 42 in the first mesh structure 4 is R1, and the bending radius of the third metal wire 51 and the fourth metal wire 52 in the second mesh structure 5 is R2. The relationship between the bending radii satisfies: R1≠R2. Such a setting is conducive to using metal wires with smaller bending radius to divide the grid formed by metal wires with larger bending radius into more grids with smaller areas, so that the grid density increases several times when the number of layers of the intra-tumor embolizer body 1 remains unchanged, which significantly enhances the blocking effect on aneurysms.

[0045] Embodiment 3: Fig.12 As shown, when the number of layers of the mesh structure of the intratumoral embolizer body 1 is C>2 and the number of layers C of the intratumoral embolizer body 1 is an even number, the Xth layer is connected to the Xth-to-last layer X=1; 2; 3; 4; 5... until all metal meshes are connected, and other metal meshes N are wrapped layer by layer in turn, which is suitable for use in different types of aneurysms.

[0046] In this embodiment, the preferred number of layers c of the intratumoral embolizer is in the range of 2≤c≤4. Within this range of layers, the intratumoral embolizer can take into account both good blocking effect and moderate self-expansion force. More preferably, an even number of layers is selected. The more layers the intratumoral embolizer body 1 has, the finer the mesh on the surface of the intratumoral embolizer body 1, the stronger the effect of slowing down the impact of blood flow, and the better the blocking and embolization effect on the aneurysm. However, the more layers the intratumoral embolizer body 1 has, the stronger the self-expansion force of the intratumoral embolizer body 1 will be. Since the self-expansion force of the intratumoral embolizer body 1 directly acts on the aneurysm wall, the aneurysm wall is relatively weak, and excessive expansion force will increase the risk of aneurysm rupture.

[0047] Specifically, as another embodiment, the intratumor embolizer body 1 also includes a third mesh structure and a fourth mesh structure that fit each other but are not intertwined. The third mesh structure and the fourth mesh structure are integrally connected at the top 11 of the intratumor embolizer body 1 and converge together and 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.

[0048] As one of the embodiments, the deflection angle α3 of the metal wire on the third mesh structure is different from the deflection angle α4 of the metal wire on the fourth mesh structure, and the deflection angle of the metal wire on the third mesh structure is different from the deflection angle of the metal wire in the first mesh structure and the deflection angle of the metal wire in the second mesh structure, and the deflection angle of the metal wire on the fourth mesh structure is different from the deflection angle of the metal wire in the first mesh structure and the deflection angle of the metal wire in the second mesh structure.

[0049] Furthermore, the deflection angle α3 of the metal wires on the third mesh structure and the deflection angle α4 of the metal wires on the fourth mesh structure satisfy: , wherein the total number of metal wires in the third mesh structure and the fourth mesh structure is the same, both being n, and k is an arbitrary integer.

[0050] When the total number of metal wires in the third mesh structure and the fourth mesh structure is set to be the same as that in the first mesh structure and the second mesh structure, the above formula can also be satisfied between the two mesh structures.

[0051] As another embodiment, the bending radius of the metal wire on the third mesh structure is different from the bending radius of the metal wire on the fourth mesh structure, and the bending radius of the metal wire on the third mesh structure is different from the bending radius of the metal wire in the first mesh structure and the bending radius of the metal wire in the second mesh structure, and the bending radius of the metal wire on the fourth mesh structure is different from the bending radius of the metal wire in the first mesh structure and the bending radius of the metal wire in the second mesh structure.

[0052] It should be understood by those skilled in the art that the discussion of any of the above embodiments is merely illustrative and is not intended to imply that the scope of the present invention (including the claims) is limited to these examples. Under the concept of the present invention, the technical features in the above embodiments or different embodiments may also be combined, the steps may be implemented in any order, and there are many other variations of the different aspects of the present invention as described above, which are not provided in detail for the sake of simplicity.

[0053] The present invention is intended to cover all such substitutions, modifications and changes that fall within the broad scope of the appended claims. Therefore, any omissions, modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. An intratumoral embolizer, comprising an intratumoral embolizer body (1) woven by intersecting 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 attached and do not intersect; 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 interwoven 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 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 intersect 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), and 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 transitional 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 intratumor embolization device according to claim 1, characterized in that: When the intratumoral embolizer body (1) is unfolded, 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 intratumor 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) than the second curved surface (122), the first curved surface (121) is concave in the direction of blood flow impact, 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, the bending radius of the second curved surface (122) is T2, and the bending radius T1 and the bending radius T2 satisfy T1<T2, and the first curved surface (121) is connected to the second curved surface (122) and the transition between them is smooth.

4. The intratumor 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. The first mesh structure (4) and the second mesh structure (5) are uniformly formed by a plurality of arc-shaped metal wires interlaced. The first metal wire (41), the second metal wire (42), the third metal wire (51) and the fourth metal wire (52) are all made of 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 intratumor embolizer body (1), and the other end thereof is directed toward the top (13). 1) diverges and is evenly arranged in a circular pattern on the first mesh structure (4), the first metal wire (41) and the third metal wire (51) are clockwise metal wires, 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, the third metal wire (51) and the fourth metal wire (52) are connected at the top (11) to form a closed loop, and the areas of the first mesh (43) and the second mesh gradually decrease from the top (11) to the bottom (13).

5. The intratumor embolization device according to claim 1, characterized in that: The deflection angle between the first metal wire (41) and the second metal wire (42) and the horizontal line is α1, the deflection angle between the third metal wire (51) and the fourth metal wire (52) and the horizontal line is α2, and α1≠α2.

6. The intratumor embolization device according to claim 5, characterized in that: The relationship between the deflection angles α1 and α2 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 an arbitrary integer.

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

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

9. The intratumor embolization device according to claim 1, characterized in that: The intratumor embolization device body (1) further comprises a third mesh structure and a fourth mesh structure which are fitted to each other but not intertwined with each other. The third mesh structure and the fourth mesh structure are integrally connected at the top (11) of the intratumor embolization device body (1) and converged together and 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 intratumor embolization device, characterized in that: It comprises an intratumor embolizer according to any one of claims 1 to 9 and a delivery system for delivering and deploying the intratumor embolizer; The delivery system comprises 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 intratumoral embolizer body (1) via the release wire (3). The delivery device (2) is used to deliver and implant the intratumoral embolizer (1) into the aneurysm. After the intratumoral embolizer is deployed, the release wire (3) is broken to achieve release of the intratumoral embolizer.

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