Aneurysm embolism device with good anchoring effect

Abstract

The utility model relates to the technical field of medical instruments, and discloses an aneurysm embolism device with a good anchoring effect. The intratumoral embolism device comprises an intratumoral embolism device formed by weaving metal wires with a fixed weaving strand number and a conveying system used for delivering the intratumoral embolism device into an aneurysm for implantation, rhombic grids formed by weaving a plurality of metal wires in a staggered mode are arranged on the intratumoral embolism device, and the intratumoral embolism device comprises a top, a middle and a bottom. The diameter of the intratumoral embolism device in an unfolded state is gradually reduced from the top to the bottom, and the whole intratumoral embolism device is funnel-shaped. According to the intratumoral embolism device, the funnel-shaped structure is adopted, and the stacking area is arranged at the top of the intratumoral embolism device, so that the intratumoral embolism device can be stably and firmly anchored in an aneurysm after being implanted in the aneurysm, and the problems that the intratumoral embolism device is disengaged from the aneurysm in the operation process or shifts due to the impact of blood flow and the like are solved.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to an aneurysm embolization device with good anchoring effect. Background Technology

[0002] Intracranial aneurysms are pathological expansions formed in weak areas of the intracranial blood vessel walls due to the long-term impact of unstable blood flow. They are characterized by high incidence, high disability rate, and high mortality rate, seriously endangering the lives and health of patients. Wide-necked aneurysms at the bifurcation of intracranial arteries present a challenge for interventional treatment due to the large branches originating near the aneurysm neck. Because wide-necked aneurysms at bifurcation involve multiple branches, traditional treatment methods are quite complex. Currently, traditional stent-assisted coil embolization and flow diversion devices are insufficient to overcome this problem. In recent years, intra-aneurysmal embolization devices have emerged that can interfere with blood flow at the aneurysm neck to enter the aneurysm, overcoming the shortcomings of traditional devices.

[0003] For example, related technology (CN219021359U) discloses an aneurysm closure device and an aneurysm closure device delivery system. The aneurysm closure device includes: a supporting attachment portion, a neck closure portion, and a tightening and collecting portion connected sequentially from distal to proximal; the supporting attachment portion has a distal opening, and the proximal end of the neck closure portion is constricted by the tightening and collecting portion; the supporting attachment portion and the neck closure portion each include their own elastic skeleton, and the neck closure portion also includes a sealing membrane that covers and connects to the elastic skeleton of the neck closure portion circumferentially; in the implanted state, the supporting attachment portion supports and fixes itself to the aneurysm wall, and the neck closure portion isolates and closes the neck of the aneurysm, thereby isolating the parent artery from the aneurysm cavity. The aneurysm closure device provided by this technical solution can completely isolate the blood flow between the parent artery and the aneurysm cavity, thus repairing the neck of the aneurysm.

[0004] However, existing intra-aneurysmal embolization devices also have some shortcomings. For example, the anchoring effect of the intra-aneurysmal embolization device within the aneurysm is poor, the embolization device is prone to displacement during release and dislodging from the aneurysm, and the embolization device is also at high risk of displacement due to blood flow impact after implantation into the aneurysm, which endangers the patient's health. Therefore, it is necessary to propose an aneurysm embolization device with good anchoring effect. Utility Model Content

[0005] To solve the above-mentioned technical problems, this utility model provides an aneurysm embolization device with good anchoring effect.

[0006] This utility model is achieved by the following technical solution: an intra-anesthetic embolizer made of metal wires with a fixed number of braids and a delivery system for delivering the intra-anesthetic embolizer to the aneurysm for implantation. The intra-anesthetic embolizer is provided with a diamond-shaped grid formed by several metal wires interlaced and woven together. The intra-anesthetic embolizer includes a top, a middle and a bottom, and the diameter of the intra-anesthetic embolizer in the unfolded state gradually decreases from the top to the bottom. The overall shape is funnel-shaped. The diamond-shaped grid at the top of the intra-anesthetic embolizer is stacked to form a ring-shaped stacked area with a higher grid density than other parts.

[0007] Preferably, the rhomboid mesh includes a stacked rhomboid mesh and a non-stacked rhomboid mesh. The stacked rhomboid mesh is located in the annular stacked area of ​​the intratumoral embolizer, and the non-stacked rhomboid mesh is located in other areas of the intratumoral embolizer except for the annular stacked area. The stacked rhomboid mesh is stacked in the axial direction of the intratumoral embolizer by compression and / or overlap to form an annular stacked area.

[0008] Specifically, the length of the rhomboid mesh in the axial direction of the intratumoral embolizer is axial length a, and the length in the circumferential direction of the intratumoral embolizer is circumferential width b. The ratio of the axial length a to the circumferential width b of the rhomboid mesh, a / b, is the aspect ratio of the rhomboid mesh. The rhomboid mesh in the stacked region is compressed in the axial direction of the intratumoral embolizer, so that the aspect ratio of the rhomboid mesh in the stacked region is smaller than the aspect ratio of the rhomboid mesh in the non-stacked region.

[0009] Preferably, the ratio of the radial length a to the circumferential width b of the diamond mesh in the stacked area is in the range of 0 ≤ a / b ≤ 0.125, and the ratio of the radial length a to the circumferential width b of the diamond mesh in the non-stacked area is in the range of 0.8 ≤ a / b ≤ 1.2.

[0010] Furthermore, the aspect ratio of the diamond-shaped grid in the stacked region is set to be uniform or gradually decreases along the axial direction of the intratumoral embolizer.

[0011] Specifically, the number of braided strands used in the annular stacked area of ​​the intratumoral embolizer is the same as the number of braided strands used in other areas.

[0012] Preferably, the outer diameter of the annular stacked region is D1 and the inner diameter is D2, and the outer and inner diameters of the annular stacked region satisfy: D1>D2≥0.9*D1.

[0013] Furthermore, the bottom of the intratumoral embolizer is provided with a hollow collar, the bottom of the intratumoral embolizer extends and converges into the hollow collar and is fixedly connected to the hollow collar, the delivery system includes a delivery rod and a release wire with a diameter smaller than the delivery rod, the two ends of the release wire are respectively connected to the delivery rod and the hollow collar.

[0014] As a further improvement to the above solution, the hollow collar has a cylindrical structure, the bottom of the intratumoral embolizer extends into the hollow collar and is fixedly connected to the hollow collar, and one end of the release wire extends into the hollow collar and is connected to the hollow collar.

[0015] As a further improvement to the above solution, the end of the hollow collar near the release wire is a smooth hemispherical shape, which allows the hollow collar to guide and divert blood flow to the periphery when it impacts the bottom of the intratumoral embolization device.

[0016] Specifically, the intratumoral embolization device is a mesh structure made of interwoven metal wires with shape memory and good elasticity.

[0017] Preferably, the metal wire of the braided tumor embolizer is a nickel-titanium wire.

[0018] Compared with the prior art, the beneficial effects of this utility model are as follows:

[0019] The conventional method to enhance the anchoring effect of intratumoral embolization devices is to use a larger diameter intratumoral embolization device. The disadvantage of this method is that it will reduce the adhesion effect of the embolization device to the wall, and when the embolization device adopts a multi-layer structure, it is easy for the layers to not adhere properly and separate, thus weakening the sealing effect.

[0020] The advantage of the stacked design in this invention is that, during the release of the intra-anesthetic embolizer, the metal wires in the annular stacked area will extend first, increasing the contact area between the top of the embolizer and the aneurysm wall, thereby generating greater friction. Furthermore, the high mesh density of the annular stacked area gives it stronger self-expansion force. The combination of greater friction and self-expansion force makes the intra-anesthetic embolizer more firmly fixed within the aneurysm, thus significantly enhancing its anchoring effect without increasing the diameter of the embolizer. Attached Figure Description

[0021] Figure 1 This is a first overall view of the aneurysm embolization device with good anchoring effect of this utility model;

[0022] Figure 2 This is a second overall view of the aneurysm embolization device with good anchoring effect of this utility model;

[0023] Figure 3 This is a diagram showing the expanded aneurysm embolizer of this invention, which has a good anchoring effect.

[0024] Figure 4 An illustration showing the initial state of the aneurysm implantation process using an intraneural embolization device;

[0025] Figure 5A diagram illustrating the post-dilation state of an aneurysm during the implantation of an intra-aneurysmal embolization device;

[0026] Figure 6 A schematic diagram showing the first diameter range of the intratumoral embolization device;

[0027] Figure 7 A schematic diagram showing the second diameter range of the intratumoral embolization device;

[0028] Figure 8 A magnified view of the diamond-shaped grid of the intratumoral embolization device;

[0029] Figure 9 This is an enlarged view of the diamond grid in the stacked area and the diamond grid in the non-stacked area of ​​the intratumoral embolization device.

[0030] Explanation of key symbols:

[0031] 1. Intratumoral embolization device; 11. Top; 12. Middle; 13. Bottom; 14. Hollow collar; 2. Delivery system; 21. Delivery rod; 22. Release wire; 41. Diamond grid; 42. Stacked area diamond grid; 43. Non-stacked area diamond grid. Detailed Implementation

[0032] The present invention will now be further described in conjunction with the accompanying drawings and specific embodiments.

[0033] Please combine Figures 1 to 9 An aneurysm embolizer with good anchoring effect includes: an intraneural embolizer 1 made of metal wires with a fixed number of braids and suitable for wide-necked aneurysms at the bifurcation of intracranial arteries; and a delivery system 2 for delivering the intraneural embolizer 1 into the aneurysm for implantation. The intraneural embolizer 1 is provided with a diamond-shaped mesh 41 formed by several metal wires interlaced. The intraneural embolizer 1 consists of three parts: a top 11, a middle 12, and a bottom 13. The intraneural embolizer 1 has a compressed bundled state and an expanded unfolded state. The diameter of the intraneural embolizer 1 in the unfolded state gradually decreases from the top 11 to the bottom 13, and the overall shape is funnel-shaped. The diamond-shaped mesh 41 of the top 11 of the intraneural embolizer 1 is stacked to form an annular stacked area with a higher mesh density than other parts. The annular stacked area starts from the top 11 of the intraneural embolizer 1 and extends towards the middle 12 of the intraneural embolizer 1. The purpose of the annular stacked area is to enhance the anchoring effect of the contact area.

[0034] Through the above technical solution, the intraneural embolizer 1 adopts a mesh structure made of interwoven metal with shape memory and good elasticity, thus having a self-expansion function. Under the action of external load, the intraneural embolizer 1 deforms into a bundled state, and after the external load is removed, it can spontaneously restore its initial shape (the initial shape is an unfolded state). That is, the intraneural embolizer 1 is compressed into a bundled state to enter the aneurysm during delivery, and after release, the intraneural embolizer 1 will expand and unfold into an unfolded state to abut against the aneurysm wall.

[0035] The top 11 of the intra-aneurysmal embolizer 1 generates a self-expansion force F1 on the aneurysm wall, and a frictional force F2 is generated between the top 11 of the intra-aneurysmal embolizer 1 and the aneurysm wall. The anchoring force of the intra-aneurysmal embolizer 1 is F. The relationship between the anchoring force F of the intra-aneurysmal embolizer 1, the self-expansion force F1, and the frictional force F2 is: F = F1 + F2. Under the combined action of the self-expansion force F1 and the frictional force F2, the position of the top 11 of the intra-aneurysmal embolizer 1 is fixed, thus achieving the anchoring effect.

[0036] The wires in the annular stacked region extend out upon release, increasing the contact area between the top of the embolizer and the aneurysm wall, thereby generating a greater frictional force F2. Furthermore, the high mesh density of the annular stacked region gives it a stronger self-expanding force F1. When the greater frictional force F2 combines with the self-expanding force F1, it enhances the anchoring force F of the intra-aneurysmal embolizer 1, making the fixation of the intra-aneurysmal embolizer within the aneurysm more stable. This significantly enhances the anchoring effect of the intra-aneurysmal embolizer without increasing its diameter.

[0037] In this embodiment, the number of braided strands used in the annular stacked area of ​​the intraneural embolizer 1 is the same as that in other areas. This avoids irritation to the aneurysm from the broken ends and also prevents excessive expansion force in the annular stacked area from damaging the aneurysm due to differences in the number of strands. Furthermore, the simple manufacturing process of the intraneural embolizer with the same number of strands avoids increased product costs. In addition, setting various specifications of braided strands for the intraneural embolizer can create intraneural embolizers with different radial force requirements.

[0038] Furthermore, in this embodiment, the outer diameter of the annular stacked region is D1, and the inner diameter is D2. The outer and inner diameters of the annular stacked region satisfy: D1 > D2 ≥ 0.9 * D1. Controlling the outer and inner diameters of the annular stacked region within a suitable range avoids both an excessively small annular stacked region affecting the anchoring effect and an excessively large annular stacked region causing a significant increase in the extension of the intratumoral embolizer 1 when it extends to cover the aneurysm neck. Conversely, if the bottom 13 of the intratumoral embolizer 1 extends too far beyond the aneurysm neck, it will affect the blood flow in the normal branch vessels.

[0039] In this embodiment, a hollow collar 14 is provided on the bottom 13 of the intraneural embolizer 1. The bottom 13 of the intraneural embolizer 1 extends and converges into the hollow collar 14 and is fixedly connected to the hollow collar 14. The delivery system 2 includes a delivery rod 21 and a release wire 22 with a diameter smaller than that of the delivery rod 21. The two ends of the release wire 22 are respectively connected to the delivery rod 21 and the hollow collar 14. The delivery rod 21 has a slender rod-shaped structure, which makes it easier to deliver the intraneural embolizer 1 and implant it into the aneurysm. The hollow collar 14 has a cylindrical structure, and one end of the release wire 22 extends into the hollow collar 14 and is connected to the hollow collar 14.

[0040] The hollow collar 14 is a smooth hemispherical shape at the end near the release wire 22, which allows the hollow collar 14 to guide and divert the blood flow to the periphery when it impacts the bottom 13 of the embolizer 1 in the aneurysm.

[0041] The intratumoral embolization device 1 is a mesh structure made of interwoven metal wires with shape memory and good elasticity. Specifically, in this embodiment, the metal wires used to weave the intratumoral embolization device 1 are nickel-titanium wires.

[0042] To ensure the anchoring effect of the intratumoral embolization device 1 through the above technical solution, it is first necessary to ensure the self-expansion of the intratumoral embolization device 1. Therefore, metal wires with shape memory and good elasticity are preferred. Nickel-titanium wire has both strength and flexibility, as well as biocompatibility. After surface treatment by electropolishing and passivation, it will form a passivated titanium oxide layer, forming a barrier to prevent corrosion and the release of toxic nickel ions into the blood. The stacked area composed of a mesh woven from nickel-titanium wire has excellent self-expansion and can be perfectly adapted to the intratumoral embolization device 1 with the stacked area.

[0043] Specifically, in this embodiment, the rhomboid mesh 41 includes a stacked rhomboid mesh 42 and a non-stacked rhomboid mesh 43. The stacked rhomboid mesh 42 is located in the annular stacked area of ​​the intratumoral embolizer 1, and the non-stacked rhomboid mesh 43 is located in other areas of the intratumoral embolizer 1 other than the annular stacked area. The stacked rhomboid mesh 42 is stacked in the axial direction of the intratumoral embolizer 1 by compression and / or overlap to form an annular stacked area.

[0044] Specifically, in one embodiment, the length of the rhomboid mesh 41 in the axial direction of the intratumoral embolizer 1 is axial length a, and the length in the circumferential direction of the intratumoral embolizer 1 is circumferential width b. The ratio a / b of the axial length a and circumferential width b of the rhomboid mesh 41 is the aspect ratio of the rhomboid mesh 41. The stacked rhomboid mesh 42 is compressed in the axial direction of the intratumoral embolizer 1, so that the aspect ratio of the stacked rhomboid mesh 42 is smaller than that of the non-stacked rhomboid mesh 43. The mesh density of the stacked rhomboid mesh 42 is P1, and the mesh density of the non-stacked rhomboid mesh 43 is P2. The mesh density relationship between the two is P1>P2. That is, the stacked rhomboid meshes in the stacked region are stacked in the axial direction of the intratumoral embolizer through mesh compression to form a ring-shaped stacked region with a higher mesh density than other parts.

[0045] Furthermore, the ratio of the axial length a to the circumferential width b of the diamond mesh 42 in the stacked region is in the range of 0 to 0.125 (i.e., 0 ≤ a / b ≤ 0.125), and the ratio of the axial length a to the circumferential width b of the diamond mesh 43 in the non-stacked region is in the range of 0.8 to 1.2 (i.e., 0.8 ≤ a / b ≤ 1.2).

[0046] Through the above technical solution, the intra-anesthetic embolizer 1 is formed by interlaced metal wires, and the aspect ratio of the diamond grid 42 in the stacked area is small, so that the annular stacked area can accommodate more metal wires while maintaining a small area, thus having a higher metal coverage. This means that when the metal wire diameter and the number of strands are the same, the higher the grid density, the greater the self-expansion force F1 of the intra-anesthetic embolizer 1. Therefore, the annular stacked area at the top 11 of the intra-anesthetic embolizer 1 has a better anchoring effect in the aneurysm. In this application, the aspect ratio of the diamond grid 42 in the stacked area is a / b=0, which makes the metal wires in the stacked area stick together tightly without grid gaps. At this time, the metal coverage of the annular stacked area reaches 100%, which maximizes the self-expansion force of the stacked area and achieves the best anchoring effect with the aneurysm wall. In the annular stacked region, the aspect ratio of the diamond grid 42 in the stacked region is set to be uniform; the aspect ratio of the diamond grid 42 in the stacked region can also be set to be different. Preferably, the aspect ratio of the diamond grid 42 in the stacked region gradually decreases along the axial direction of the intratumoral embolizer 1, so that the self-expansion force of the intratumoral embolizer 1 forms a smooth transition between the annular stacked region and other non-stacked regions.

[0047] In another embodiment, the diamond grids 42 in the stacked region at least partially overlap. That is, the diamond grids in the stacked region are stacked by grid overlap in the axial direction of the intratumoral embolizer to form a ring-shaped stacked region with a higher grid density than other parts.

[0048] In another embodiment, the diamond grids 42 in the stacked region at least partially overlap and have an aspect ratio smaller than that of the diamond grids 43 in the non-stacked region. That is, the diamond grids in the stacked region overlap and compress in the axial direction of the intratumoral embolizer to form a ring-shaped stacked region with a higher grid density than other parts.

[0049] The implementation principle of an aneurysm embolization device with good anchoring effect in this application embodiment is as follows:

[0050] During implantation, the top 11 of the intra-anesthetic embolizer 1 first expands and contacts the aneurysm wall. At this time, the top 11 of the intra-anesthetic embolizer 1 will generate a self-expansion force F1 on the aneurysm wall. After the top 11 of the intra-anesthetic embolizer 1 contacts the aneurysm wall, due to the presence of a contact surface, a frictional force F2 will be generated between the top 11 of the intra-anesthetic embolizer 1 and the aneurysm wall. Under the combined action of the self-expansion force F1 and the frictional force F2, the position of the top 11 of the intra-anesthetic embolizer 1 is fixed, achieving an anchoring effect.

[0051] After the intra-anesthetic embolizer 1 is fixed to the aneurysm wall by the anchoring force F, the delivery system 2 will pull the intra-anesthetic embolizer 1, and the middle part 12 of the intra-anesthetic embolizer 1 will extend and cover the neck of the aneurysm. After the middle part 12 extends and covers the neck of the aneurysm, the blood flow is blocked through the fine mesh on the intra-anesthetic embolizer 1, thereby reducing the impact of blood on the aneurysm. The protruding hollow collar 14 at the bottom 13 of the intra-anesthetic embolizer 1 can divert blood and guide it to normal blood vessels.

[0052] The above embodiments are merely preferred embodiments of this utility model and should not be construed as limiting the scope of protection of this utility model. Any non-substantial changes and substitutions made by those skilled in the art based on this utility model shall fall within the scope of protection claimed by this utility model.

Claims

1. An aneurysm embolizer with good anchoring effect, comprising an intra-anesthetic embolizer (1) woven from metal wires of a fixed number of braids and a delivery system (2) for delivering the intra-anesthetic embolizer (1) into the aneurysm for implantation, wherein the intra-anesthetic embolizer (1) is provided with a diamond-shaped mesh (41) formed by interlacing a plurality of metal wires, characterized in that: The intratumoral embolizer (1) includes a top (11), a middle (12) and a bottom (13), and the diameter of the intratumoral embolizer (1) in the unfolded state gradually decreases from the top (11) to the bottom (13), and the overall shape is funnel-shaped. The diamond grid (41) of the top (11) of the intratumoral embolizer (1) is stacked to form an annular stacked area with a higher grid density than other parts.

2. The aneurysm embolization device with good anchoring effect as described in claim 1, characterized in that, The rhomboid mesh (41) includes a stacked area rhomboid mesh (42) and a non-stacked area rhomboid mesh (43). The stacked area rhomboid mesh (42) is located in the annular stacked area of ​​the intratumoral embolizer (1), and the non-stacked area rhomboid mesh (43) is located in other areas of the intratumoral embolizer (1) other than the annular stacked area. The stacked area rhomboid mesh (42) is stacked in the axial direction of the intratumoral embolizer (1) by compression and / or overlap to form an annular stacked area.

3. The aneurysm embolization device with good anchoring effect as described in claim 2, characterized in that, The length of the rhomboid mesh (41) in the axial direction of the intratumoral embolizer (1) is axial length a, and the length in the circumferential direction of the intratumoral embolizer (1) is circumferential width b. The ratio of the axial length a to the circumferential width b of the rhomboid mesh (41) is the aspect ratio of the rhomboid mesh (41). The stacked area rhomboid mesh (42) is compressed in the axial direction of the intratumoral embolizer (1), so that the aspect ratio of the stacked area rhomboid mesh (42) is smaller than the aspect ratio of the non-stacked area rhomboid mesh (43).

4. The aneurysm embolization device with good anchoring effect as described in claim 3, characterized in that, The ratio of the radial length a to the circumferential width b of the diamond mesh (42) in the stacked area is 0 ≤ a / b ≤ 0.125, and the ratio of the radial length a to the circumferential width b of the diamond mesh (43) in the non-stacked area is 0.8 ≤ a / b ≤ 1.

2.

5. The aneurysm embolization device with good anchoring effect as described in claim 3, characterized in that, The aspect ratio of the diamond grid (42) in the stacked area is set to be uniform or gradually decreases along the axial direction of the intratumoral embolizer (1).

6. The aneurysm embolization device with good anchoring effect as described in claim 1, characterized in that, The number of braided strands used in the annular stacked area of ​​the intratumoral embolizer (1) is the same as the number of braided strands in other areas.

7. The aneurysm embolization device with good anchoring effect as described in claim 2, characterized in that, The outer diameter of the annular stacked region is D1, and the inner diameter is D2. The outer and inner diameters of the annular stacked region satisfy: D1>D2≥0.9*D1.

8. The aneurysm embolization device with good anchoring effect as described in claim 1, characterized in that, The bottom (13) of the intratumoral embolizer (1) is provided with a hollow collar (14). The bottom (13) of the intratumoral embolizer (1) extends and converges into the hollow collar (14) and is fixedly connected to the hollow collar (14). The delivery system (2) includes a delivery rod (21) and a release wire (22) with a diameter smaller than that of the delivery rod (21). The two ends of the release wire (22) are respectively connected to the delivery rod (21) and the hollow collar (14).

9. The aneurysm embolization device with good anchoring effect as described in claim 8, characterized in that, The hollow collar (14) has a cylindrical structure, and one end of the release wire (22) extends into the hollow collar (14) and is connected to the hollow collar (14).

10. The aneurysm embolization device with good anchoring effect as described in claim 9, characterized in that, The hollow collar (14) is a smooth hemispherical shape at the end near the release wire (22). When the blood flow impacts the bottom (13) of the intratumoral embolizer (1), the hollow collar (14) can guide and divert the blood flow to the periphery.

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