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A super-flexible nickel-titanium alloy intracranial stent with micro-nano structure

A technology of intracranial blood vessels and micro-nano structures, applied in the field of medical devices, can solve problems such as inconsistent diameters of blood vessels, poor adherence, and extension into aneurysms, so as to improve flexibility and adherence, reduce discounts and ovalization, The effect of promoting vascular endothelialization

Active Publication Date: 2022-01-14
INST OF METAL RESEARCH - CHINESE ACAD OF SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, intracranial blood vessels are tortuous and complex, and intracranial aneurysms are more likely to occur at the bifurcation of the cerebral base arterial ring and its main branches, and there are often different degrees of curvature, and the diameter of the blood vessels may also be inconsistent
In addition, the size of intracranial aneurysms varies greatly, and interventional treatment for some wide-necked and fusiform aneurysms is still very difficult
For existing products, intracranial stent structures are roughly divided into two types: open-loop and closed-loop. Each structural stent has its own advantages and disadvantages. For blood vessels with high curvature, the bending performance of open-loop stents is better than that of closed-loop stents. Avoid discounting, ovalization, etc. Since the stent is not connected to the connecting rod in the open-loop part, the stent has better adaptability to uneven blood vessels, but the outer gap will increase with the curvature, resulting in the risk of the coil coming out; In addition, for open-loop structural stents with long unit spans, the open-loop part may cause non-adherence or protrude into the aneurysm, causing thrombosis and other problems
Although the closed-loop structure stent can provide high support performance, due to its overall continuity and high rigidity, the stent is relatively hard as a whole, and the wall-attachment is poor after implantation, and even displacement occurs, eventually causing complications such as thrombosis and restenosis
[0004] Most of the existing products are designed with a unified structure. For complex intracranial vessels, especially those with large curvature and variable vessel diameters, there is little coordination between compliance / adherence and support performance, and it is difficult to over-embolize coils. The wide-necked, fusiform aneurysm neck provides local support, but does not solve the problems of open-loop structural support performance, gaps, and non-adherence

Method used

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  • A super-flexible nickel-titanium alloy intracranial stent with micro-nano structure
  • A super-flexible nickel-titanium alloy intracranial stent with micro-nano structure
  • A super-flexible nickel-titanium alloy intracranial stent with micro-nano structure

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] 本实施例设计了一种具有微纳结构的超柔顺镍钛合金颅内血管支架,设计的中间部位采用闭环结构局部增强,长度为2.25mm;开环结构占整个颅内血管支架表面积的30%;第二V字形单元2丝宽为0.05mm,第一V字形单元1丝宽为0.0367mm,连接杆(b)高度a为0.05mm,宽度b为0.05mm,连接杆(c)高度c为0.06mm,宽度d为0.0857mm。第一V字形单元1长度尺寸与宽度尺寸比为0.84,第二V字形单元2高度尺寸与宽度尺寸比为0.6~0.7。

[0045] Such as image 3 所示,颅内血管支架平面展开切割图。 根据设计图纸在外径为2.8mm的镍钛合金管上进行激光切割,清洗,模具扩张,热处理去应力定型,电解抛光,再次清洗等步骤制备可得最终颅内血管支架。 Such as Figure 4 所示,颅内血管支架标称直径为4.5mm,长度为25mm,显影杆长度为0.7mm,显影杆宽度为0.15mm,壁厚为0.05mm。

Embodiment 2

[0047] 本实施例对实施例1中加工的支架进行三点弯曲实验测试,以表征支架的柔顺性。 三点弯曲实验设备由两个下方固定支撑部件(4mm直径平行圆柱)和一个上方加载部件(4mm直径圆柱)组成。 采用固定跨距三点弯曲方法,下方固定支撑部件的跨距设置为20mm。 Proceed as follows:

[0048] a)装配放样:将样品垂直于固定支撑部件放置,加载部件平行于固定支撑部件进行装配,并使其处于两固定支撑部件的正中。

[0049] b)启动测试:以0.05mm / s的恒定速率施加载荷直到预定的最大挠度4.5mm。

[0050] c)记录在整个试验过程中样品是否表现出充分均匀的弯曲,并绘制载荷随挠度变化曲线。

[0051] Such as Figure 5 为三点弯曲实验测试结果。 Such as Figure 5 (a)所示,过程中支架弯曲程度,整个试验过程中支架表现出充分均匀的弯曲,未出现打折、椭圆化的现象。 Such as Figure 5 (b)所示,支架载荷-挠度曲线,计算挠度为2.75mm时实施例1支架的弯矩为0.149N*mm,低于Enterprise(0.772N*mm)闭环支架、Solitaire(0.428N*mm)闭环支架,且优于Neuroform(0.235N*mm)开环支架。

Embodiment 3

[0053] 本实施例在释放和压缩的过程中,测定实施例1中加工的支架径向支撑力与支架直径之间的关系,以表征支架的支撑性能。分别采用径向压握法和平板法:

[0054] 1.径向压握法:

[0055] a)将支架放置到设备当中,设备初始孔径被设置为7mm;

[0056] b)将支架直径以0.0156mm / s的速度减小至0.5mm;

[0057] c)然后孔径以0.0156mm / s的速度增加,并且支架被缓慢卸载至4.5mm;

[0058] d)在支架压握过程中,记录径向力与支架直径之间的关系。

[0059] 2.平板法:

[0060] a)将支架放置于两平板之间,并使其处于部件中心,调节压头刚好贴于支架表面;

[0061] b)以0.05mm / s的恒定速率施加载荷直到位移达到支架直径的50%(即2.25mm),再以相同的速度回位;

[0062] c)记录载荷-位移曲线。

[0063] Such as Image 6 为支架径向支撑性能测试结果。 Such as Image 6 (a)所示,采用径向压握法测试径向支撑力随直径变化曲线,在目标血管直径3.0mm、4.0mm处实施例1支架径向支撑力分别为1.58N、0.929N;如 Image 6 (b)所示,采用平板法测试平板支撑力随变形量变化曲线,在变形量达到支架直径的50%(即2.25mm)时,开环支架力值达到0.01605N / mm,高于Neuroform(0.0065N / mm)开环支架、Enterprise(0.0082N / mm)闭环支架、Solitaire(0.0106N / mm)闭环支架,具有足够的径向支撑力。

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Abstract

The invention relates to a super-compliant nickel-titanium alloy intracranial vascular stent with a micro-nano structure, which can be used to assist coil embolization in the treatment of intracranial aneurysms, and belongs to the field of medical devices. The main body of the intracranial vascular stent is composed of an open-loop structure and a closed-loop structure. The open-loop structure is formed by connecting the first V-shaped unit arranged in the circumferential direction with the second V-shaped unit arranged in the circumferential direction through connecting rods. The closed-loop structure consists of The second V-shaped units arranged in the circumferential direction are connected by connecting rods, and the ratio of the open-loop free ends of the second V-shaped units to the open-loop free ends of the first V-shaped units is 1:2; the open-loop structure enhances the flexibility of the bracket And adherent, closed-loop construction provides supportive performance. The intracranial vascular stent of the present invention has super-flexible performance, and can be used for assisting coil embolization in the treatment of aneurysms in complex intracranial vessels (such as large-curvature vessels and variable-diameter vessels), achieving good wall-attachment effects.

Description

technical field [0001] The invention relates to a super-compliant nickel-titanium alloy intracranial vascular stent with a micro-nano structure, which can be used to assist coil embolization in the treatment of intracranial aneurysms, and belongs to the field of medical devices. Background technique [0002] Intracranial aneurysm is the abnormal bulging of the intracranial artery wall due to congenital abnormal defects of blood vessels or acquired lesion trauma and other factors, and is the primary cause of subarachnoid hemorrhage. Compared with aneurysm clipping and ligation, endovascular interventional therapy is safer and more adaptable. It is currently the main intracranial aneurysm treatment method. Aneurysm occlusion can be achieved by intracranial vascular stent-assisted coil embolization . [0003] However, intracranial blood vessels are tortuous and complex, and intracranial aneurysms are more likely to occur at the bifurcation of the arterial ring at the base of t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61F2/90
CPCA61F2/90A61F2310/00071A61F2310/00023
Inventor 张兴燕阳阳郭峰韩日峥杨锐
Owner INST OF METAL RESEARCH - CHINESE ACAD OF SCI
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