Aneurysm embolism device with good anchoring effect
The intratumoral embolizer with a diamond grid and annular stacking design provides enhanced anchoring by combining self-expansion and friction forces, addressing the anchoring issues of existing devices and ensuring stability within the aneurysm.
Patent Information
- Application Number
- CN202411406999.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-10
- Publication Date
- 2024-12-06
AI Technical Summary
Existing intratumoral embolization devices suffer from poor anchoring effects, leading to displacement during release and increased risk of falling out of the aneurysm due to blood flow impact, posing a threat to patient health.
An intratumoral embolizer woven from metal wires with a diamond grid design, featuring a funnel-shaped structure with an annular stacking area of higher grid density, enhanced by a self-expanding force and increased friction, anchored by a hollow ring for stability.
The embolizer achieves robust anchoring within the aneurysm without increasing diameter, utilizing a combination of self-expansion and friction forces to securely fix the device, reducing the risk of displacement and enhancing treatment efficacy.
Smart Images
Figure CN119074113A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and in particular to an aneurysm embolizer with good anchoring effect. 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 neck of the aneurysm. Wide-necked aneurysms at the bifurcation involve multiple branches, so traditional treatment methods are relatively complicated. Currently, traditional stent-assisted coil embolization and blood flow guidance devices are difficult to overcome this problem. In recent years, intratumor 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.
[0003] For example, the related art (CN219021359U) discloses an aneurysm closure device and an aneurysm closure device delivery system. The aneurysm closure device includes: a support attachment part, a neck closure part and a tightening collection part connected in sequence from the distal end to the proximal end; the distal end of the support attachment part is open, and the proximal end of the neck closure part is converged at the tightening collection part; the support attachment part and the neck closure part respectively include their own elastic skeletons, and the neck closure part also includes a closure membrane that circumferentially covers and is connected to the elastic skeleton of the neck closure part; in the implanted state, the support attachment part is supported and fixed to the aneurysm wall, and the neck closure part isolates and closes the neck of the aneurysm to isolate the parent artery from the aneurysm cavity. The aneurysm closure device provided by this technical solution can completely isolate the blood flow of the parent artery and the aneurysm cavity, and play a role in repairing the neck of the aneurysm.
[0004] However, existing intra-tumor embolization devices also have some shortcomings. For example, the anchoring effect of intra-tumor embolization devices in the aneurysm is poor, the embolization devices are easily displaced during the release process and fall out of the aneurysm, and the risk of the embolization devices being displaced by blood flow impact after implantation in the aneurysm is also high, which endangers the health of the patient. Therefore, it is necessary to propose an aneurysm embolization device with good anchoring effect. Summary of the invention
[0005] In order to solve the above technical problems, the present invention provides an aneurysm embolizer with good anchoring effect.
[0006] The present invention is implemented by the following technical scheme: an intratumoral embolizer woven from metal wires with a fixed number of braided strands and a delivery system for delivering the intratumoral embolizer to an aneurysm for implantation, the intratumoral embolizer being provided with a diamond grid formed by a plurality of metal wires interlaced and woven, the intratumoral embolizer comprising a top, a middle and a bottom, and the diameter of the intratumoral embolizer in an expanded state gradually decreases from the top to the bottom, and the overall shape is funnel-shaped, the diamond grids at the top of the intratumoral embolizer are stacked to form an annular stacking area with a higher grid density than other parts.
[0007] Preferably, the diamond grid includes a stacking area diamond grid and a non-stacking area diamond grid, the stacking area diamond grid is located in the annular stacking area of the intratumor embolizer, and the non-stacking area diamond grid is located in other areas of the intratumor embolizer except the annular stacking area, and the stacking area diamond grid is stacked by compression and / or overlap in the axial direction of the intratumor embolizer to form an annular stacking area.
[0008] Specifically, the length of the diamond grid in the axial direction of the intratumor embolizer is the axial length a, and the length in the circumferential direction of the intratumor embolizer is the circumferential width b. The ratio a / b of the axial length a of the diamond grid to the circumferential width b is the aspect ratio of the diamond grid. The stacked area diamond grid is compressed in the axial direction of the intratumor embolizer, so that the aspect ratio of the stacked area diamond grid is smaller than the aspect ratio of the non-stacked area diamond grid.
[0009] Preferably, the ratio of the radial length a to the circumferential width b of the diamond grid in the stacking 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 grid in the non-stacking area is in the range of 0.8≤a / b≤1.2.
[0010] Furthermore, the aspect ratio of the diamond grids in the stacking area is set to be uniform or gradually decrease along the axial direction of the intratumor embolizer.
[0011] Specifically, the number of braided strands used in the annular stacking region of the intratumor embolizer is the same as the number of braided strands used in other regions.
[0012] Preferably, the outer diameter of the annular stacking area is D1, and the inner diameter is D2, and the outer and inner diameters of the annular stacking area satisfy: D1>D2≥0.9*D1.
[0013] Furthermore, a hollow ring is provided at the bottom of the intratumor embolizer, and the bottom of the intratumor embolizer extends and converges into the hollow ring and is fixedly connected to the hollow ring. The conveying system includes a delivery rod and a release wire with a diameter smaller than the delivery rod, and the two ends of the release wire are respectively connected to the delivery rod and the hollow ring.
[0014] As a further improvement of the above scheme, the hollow ring is a cylindrical structure, the bottom of the intratumor embolizer extends into the hollow ring and is fixedly connected to the hollow ring, and one end of the release wire extends into the hollow ring and is connected to the hollow ring.
[0015] As a further improvement of the above solution, the end of the hollow ring close to the release wire is hemispherical with a smooth surface, so that when the blood flow impacts the bottom of the intratumor embolizer, the hollow ring can guide and divert the blood flow to the periphery.
[0016] Specifically, the intratumor embolizer is a mesh structure formed by interlacing and weaving metal wires with shape memory capability and good elasticity.
[0017] Preferably, the metal wire of the braided intratumor embolizer is nickel-titanium wire.
[0018] Compared with the prior art, the present invention has the following beneficial effects: Conventional methods for enhancing the anchoring effect of intratumoral embolic devices are to use intratumoral embolic devices with larger diameters. The disadvantage of this method is that the adhesion effect of the embolic device to the wall becomes worse, and when the embolic device adopts a multi-layer structure, the layers are prone to not fitting together and separation, which weakens the blocking effect. The advantage of the stacking design in the present invention is that during the release of the intratumoral embolizer, the metal wires in the annular stacking area will be extended first, so that the contact area between the top of the embolizer and the aneurysm wall is increased, thereby generating greater friction. In addition, the grid density of the annular stacking area is high, which makes it have a stronger self-expansion force. When the greater friction force is combined with the self-expansion force, the intratumoral embolizer is more firmly fixed in the aneurysm, thereby significantly enhancing the anchoring effect of the intratumoral embolizer without increasing the diameter of the intratumoral embolizer. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] Figure 1 This is a first overall display diagram of the aneurysm embolizer with good anchoring effect of the present invention; Figure 2 This is a second overall display diagram of the aneurysm embolizer with good anchoring effect of the present invention; Figure 3 This is a diagram showing the aneurysm embolizer with good anchoring effect after expansion. Figure 4 This is a diagram showing the initial state of the process of implanting an intratumoral embolization device into an aneurysm; Figure 5 This is a diagram showing the post-dilation state of the process of implanting an intratumoral embolization device into an aneurysm; Figure 6 It is a schematic diagram of the first diameter range of the intratumor embolization device; Figure 7It is a schematic diagram of the second diameter range of the intratumor embolizer; Figure 8 This is an enlarged display of the diamond grid of the intratumor embolizer; Fig. 9 This is an enlarged display of the diamond grid in the stacked area and the diamond grid in the non-stacked area of the intratumor embolizer.
[0020] Description of main symbols: 1. Intratumor embolizer; 11. Top; 12. Middle; 13. Bottom; 14. Hollow ring; 2. Delivery system; 21. Delivery rod; 22. Release wire; 41. Diamond grid; 42. Stacking area diamond grid; 43. Non-stacking area diamond grid. DETAILED DESCRIPTION
[0021] The present invention is further described below in conjunction with the accompanying drawings and specific implementation methods.
[0022] Please combine Figures 1 to 9 , an aneurysm embolizer with good anchoring effect, comprising: an intratumoral embolizer 1 woven from metal wires with a fixed number of braided strands and suitable for wide-necked aneurysms at the bifurcation of intracranial arteries, and a delivery system 2 for delivering the intratumoral embolizer 1 to the aneurysm for implantation, the intratumoral embolizer 1 is provided with a rhombus grid 41 formed by interlacing and braiding a plurality of metal wires, the intratumoral embolizer 1 is composed of three parts: a top 11, a middle 12 and a bottom 13, the intratumoral embolizer 1 has a compressed bundled state and an expanded unfolded state, 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 rhombus grids 41 at the top 11 of the intratumoral embolizer 1 are stacked to form an annular stacking area with a higher grid density than other parts, the annular stacking area starts from the top 11 of the intratumoral embolizer 1 and extends toward the middle 12 of the intratumoral embolizer 1, and the purpose of the annular stacking area is to enhance the anchoring effect of this part of the contact area.
[0023] Through the above technical solution, the intratumoral embolizer 1 adopts a mesh structure formed by metal interlacing with shape memory and good elasticity, so it has a self-expansion function. The intratumoral embolizer 1 is deformed into a bundled state under the action of an external load, and can spontaneously restore its initial shape (the initial shape is an expanded state) after the external load is removed, that is, the intratumoral embolizer 1 is compressed into a bundled state during transportation and enters the aneurysm, and after release, the intratumoral embolizer 1 will expand and expand into an expanded state and abut against the aneurysm wall; The top 11 of the intratumoral embolizer 1 generates a self-expanding force F1 on the aneurysm wall, and a friction force F2 is generated between the top 11 of the intratumoral embolizer 1 and the aneurysm wall. The anchoring force of the intratumoral embolizer 1 is F. The relationship between the anchoring force F of the intratumoral embolizer 1 and the self-expanding force F1 and the friction force F2 is: F=F1+F2. Under the combined action of the self-expanding force F1 and the friction force F2, the position of the top 11 of the intratumoral embolizer 1 is fixed, which plays an anchoring effect. The metal wires in the annular stacking area are extended when released, so that the contact area between the top of the embolizer and the aneurysm wall is increased, thereby generating a greater friction force F2; and the grid density of the annular stacking area is high, which makes it have a stronger self-expansion force F1; and when the greater friction force F2 is combined with the self-expansion force F1, the anchoring force F of the intratumoral embolizer 1 is enhanced, making the intratumoral embolizer more firmly fixed in the aneurysm, thereby significantly enhancing the anchoring effect of the intratumoral embolizer without increasing the diameter of the intratumoral embolizer.
[0024] In this embodiment, the number of braided strands used in the annular stacking area of the intratumoral embolizer 1 is the same as the number of braided strands in other areas. On the one hand, it avoids the generation of broken ends to stimulate the aneurysm, and also avoids the difference in the number of strands causing excessive expansion force in the annular stacking area to damage the aneurysm. On the other hand, the same number of strands braided intratumoral embolizers has a simple processing technology to avoid an increase in product costs. In addition, setting the number of braided strands of intratumoral embolizers of various specifications can form intratumoral embolizers with different radial force requirements.
[0025] Furthermore, in this embodiment, the outer diameter of the annular stacking area is D1, and the inner diameter is D2, and the outer and inner diameters of the annular stacking area satisfy: D1>D2≥0.9*D1. The outer and inner diameters of the annular stacking area are controlled within a suitable range, which not only avoids the annular stacking area being too small to affect the anchoring effect, but also avoids the annular stacking area being too large to cause the intratumoral embolizer 1 to extend and cover the tumor neck opening, and the bottom 13 of the intratumoral embolizer 1 extends too much out of the tumor neck opening, which affects the blood flow in the normal branch blood vessels.
[0026] In this embodiment, a hollow ring 14 is provided on the bottom 13 of the intratumoral embolizer 1, and the bottom 13 of the intratumoral embolizer 1 extends and converges into the hollow ring 14 and is fixedly connected to the hollow ring 14. The conveying system 2 includes a delivery rod 21 and a release wire 22 with a diameter smaller than the delivery rod 21, and the two ends of the release wire 22 are respectively connected to the delivery rod 21 and the hollow ring 14. The delivery rod 21 is a slender rod-shaped structure as a whole, which makes it possible to more smoothly deliver and implant the intratumoral embolizer 1 into the aneurysm. The hollow ring 14 is a tubular structure, and one end of the release wire 22 extends into the hollow ring 14 and is connected to the hollow ring 14.
[0027] The end of the hollow collar 14 close to the release wire 22 is hemispherical with a smooth surface, so that when the blood flow impacts the bottom 13 of the intratumor embolizer 1, the hollow collar 14 can guide and divert the blood flow to the periphery.
[0028] The intratumor embolizer 1 is a mesh structure formed by interlacing and weaving metal wires with shape memory and good elasticity. Specifically, in this embodiment, the metal wires used to weave the intratumor embolizer 1 are nickel-titanium wires.
[0029] Through the above technical scheme, in order to ensure the anchoring effect of the intratumor embolizer 1, it is necessary to first ensure the self-expansion of the intratumor embolizer 1. Therefore, metal wires with shape memory and good elasticity are preferably used, and nickel-titanium wires have both strength and flexibility, and are also biocompatible. After surface treatment by electropolishing and passivation, a passivated titanium oxide layer will be formed, forming a barrier to prevent corrosion and the release of toxic nickel ions into the blood. The stacking area composed of a nickel-titanium wire woven grid has excellent self-expansion and can perfectly adapt to the intratumor embolizer 1 with a stacking area.
[0030] Specifically, in the present embodiment, the diamond grid 41 includes a stacking area diamond grid 42 and a non-stacking area diamond grid 43. The stacking area diamond grid 42 is located in the annular stacking area of the intratumor embolizer 1, and the non-stacking area diamond grid 43 is located in other areas of the intratumor embolizer 1 except the annular stacking area. The stacking area diamond grid 42 is stacked by compression and / or overlap in the axial direction of the intratumor embolizer 1 to form an annular stacking area.
[0031] Specifically, in one embodiment, the length of the diamond grid 41 in the axial direction of the intratumor embolizer 1 is the axial length a, and the length in the circumferential direction of the intratumor embolizer 1 is the circumferential width b. The ratio a / b of the axial length a of the diamond grid 41 to the circumferential width b is the aspect ratio of the diamond grid 41. The stacking area diamond grid 42 is compressed in the axial direction of the intratumor embolizer 1, so that the aspect ratio of the stacking area diamond grid 42 is smaller than that of the non-stacked area diamond grid 43. The grid density of the stacking area diamond grid 42 is P1, and the grid density of the non-stacked area diamond grid 43 is P2, and the grid density relationship between the two is P1>P2. That is, the stacking area diamond grids are stacked by grid compression in the axial direction of the intratumor embolizer to form an annular stacking area with a higher grid density than other parts.
[0032] Furthermore, the ratio of the axial length a to the circumferential width b of the stacked area diamond grid 42 is in the range of 0 to 0.125 (ie, 0≤a / b≤0.125), and the ratio of the axial length a to the circumferential width b of the non-stacked area diamond grid 43 is in the range of 0.8 to 1.2 (ie, 0.8≤a / b≤1.2).
[0033] Through the above technical solution, the intratumoral embolizer 1 is formed by interlaced weaving of metal wires, and the length-to-width ratio of the diamond grid 42 in the stacking area is relatively small, so that the annular stacking area can maintain a smaller area while accommodating more metal wires, thereby having a higher metal coverage rate. This makes it possible for the mesh density to be higher when the wire diameter and the number of strands of the metal wire are the same, and the self-expansion force F1 of the intratumoral embolizer 1 is greater. Therefore, the annular stacking area at the top 11 of the intratumoral embolizer 1 has a better anchoring effect in the aneurysm. The aspect ratio of the diamond grid 42 in the stacking area of the present application is a / b=0, which makes the metal wires in the stacking area close to each other without mesh gaps. At this time, the metal coverage rate of the annular stacking area reaches 100%, which maximizes the self-expansion force of the stacking area and achieves the best anchoring effect with the aneurysm wall. In the annular stacking area, the aspect ratio of the stacking area diamond grid 42 is set to be uniform; the aspect ratio of the stacking area diamond grid 42 can also be set to be different. Preferably, the aspect ratio of the stacking area diamond grid 42 gradually decreases along the axial direction of the intratumor embolizer 1, so that the self-expansion force of the intratumor embolizer 1 forms a smooth transition between the annular stacking area and other non-stacked areas.
[0034] In another embodiment, the stacking region diamond grids 42 at least partially overlap each other. That is, the stacking region diamond grids are stacked in the axial direction of the intratumor embolizer by grid overlap to form an annular stacking region with a higher grid density than other parts.
[0035] In another embodiment, the stacking region diamond grids 42 at least partially overlap and have a smaller aspect ratio than the non-stacked region diamond grids 43. That is, the stacking region diamond grids overlap and compress in the axial direction of the intratumor embolizer to achieve stacking, so as to form an annular stacking region with a higher grid density than other parts.
[0036] The implementation principle of an aneurysm embolizer with good anchoring effect in the embodiment of the present application is: During the implantation process, the top 11 of the intratumoral embolizer 1 is first released to expand and contact the aneurysm wall. At this time, the top 11 of the intratumoral embolizer 1 will generate a self-expansion force F1 on the aneurysm wall. When the top 11 of the intratumoral embolizer 1 contacts the aneurysm wall, due to the existence of the contact surface, a friction force F2 will be generated between the top 11 of the intratumoral embolizer 1 and the aneurysm wall. Under the combined action of the self-expansion force F1 and the friction force F2, the position of the top 11 of the intratumoral embolizer 1 is fixed, which has an anchoring effect. After the intratumoral embolizer 1 is fixed to the aneurysm wall by the anchoring force F, the delivery system 2 will pull the intratumoral embolizer 1, and the middle part 12 of the intratumoral embolizer 1 will extend and cover the aneurysm neck. After the middle part 12 extends to cover the aneurysm neck, the blood flow is blocked by the fine mesh on the intratumoral embolizer 1, thereby reducing the impact of blood on the aneurysm, and the raised hollow ring 14 at the bottom 13 of the intratumoral embolizer 1 can divert the blood and guide it to the normal blood vessels.
[0037] The above-mentioned embodiments are only preferred embodiments of the present invention and cannot be used to limit the scope of protection of the present invention. Any non-substantial changes and substitutions made by technicians in this field on the basis of the present invention shall fall within the scope of protection required by the present invention.
Claims
1. An aneurysm embolizer with good anchoring effect, comprising an intra-tumor embolizer (1) woven from metal wires with a fixed number of braided strands and a delivery system (2) for delivering the intra-tumor embolizer (1) into the aneurysm for implantation, wherein the intra-tumor embolizer (1) is provided with a diamond grid (41) formed by a plurality of metal wires interlaced and braided, and characterized in that: The intratumor embolizer (1) comprises a top portion (11), a middle portion (12) and a bottom portion (13), and the diameter of the intratumor embolizer (1) in the expanded state gradually decreases from the top portion (11) to the bottom portion (13), and the overall shape is funnel-shaped. The diamond grids (41) at the top portion (11) of the intratumor embolizer (1) are stacked to form an annular stacking region with a higher grid density than other portions.
2. The aneurysm embolizer with good anchoring effect as claimed in claim 1, characterized in that: The diamond grid (41) includes a stacking area diamond grid (42) and a non-stacked area diamond grid (43), wherein the stacking area diamond grid (42) is located in the annular stacking area of the intratumor embolizer (1), and the non-stacked area diamond grid (43) is located in other areas of the intratumor embolizer (1) except the annular stacking area. The stacking area diamond grid (42) is stacked by compression and / or overlap in the axial direction of the intratumor embolizer (1) to form an annular stacking area.
3. The aneurysm embolizer with good anchoring effect as claimed in claim 2, characterized in that: The length of the diamond grid (41) in the axial direction of the intratumor embolizer (1) is the axial length a, and the length in the circumferential direction of the intratumor embolizer (1) is the circumferential width b. The ratio a / b of the axial length a of the diamond grid (41) to the circumferential width b is the length-to-width ratio of the diamond grid (41). The stacked region diamond grid (42) is compressed in the axial direction of the intratumor embolizer (1), so that the length-to-width ratio of the stacked region diamond grid (42) is smaller than the length-to-width ratio of the non-stacked region diamond grid (43).
4. The aneurysm embolizer with good anchoring effect as claimed in claim 3, characterized in that: The ratio of the radial length a to the circumferential width b of the stacked region diamond grid (42) 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 non-stacked region diamond grid (43) is in the range of 0.8≤a / b≤1.
2.
5. The aneurysm embolizer with good anchoring effect as claimed in claim 3, characterized in that: The aspect ratio of the stacked region diamond grid (42) is set to be uniform or gradually decrease along the axial direction of the intratumor embolizer (1).
6. The aneurysm embolizer with good anchoring effect as claimed in claim 1, characterized in that: The number of braided strands used in the annular stacking area on the intratumor embolizer (1) is the same as the number of braided strands used in other areas.
7. The aneurysm embolizer with good anchoring effect as claimed in claim 1, characterized in that: The outer diameter of the annular stacking area is D1, and the inner diameter is D2. The outer and inner diameters of the annular stacking area satisfy: D1>D2≥0.9*D1.
8. The aneurysm embolizer with good anchoring effect as claimed in claim 1, characterized in that: The bottom (13) of the intratumor embolizer (1) is provided with a hollow collar (14), the bottom (13) of the intratumor embolizer (1) extends and converges into the hollow collar (14) and is fixedly connected to the hollow collar (14), the delivery system (2) comprises a delivery rod (21) and a release wire (22) having a diameter smaller than that of the delivery rod (21), the two ends of the release wire (22) being respectively connected to the delivery rod (21) and the hollow collar (14).
9. The aneurysm embolizer with good anchoring effect as claimed in claim 8, characterized in that: The hollow collar (14) is 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 embolizer with good anchoring effect as claimed in claim 9, characterized in that: The end of the hollow collar (14) close to the release wire (22) is hemispherical with a smooth surface. 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 surrounding area.