用于病变血管修补的血管支架 Vascular stent for diseased blood vessel repair
技术领域Technical field
本发明涉及一种用于治疗血管畸形的植入性器械， 尤其涉及一种用于 载瘤动脉修补的新型血管支架。 更具体是一种具有低网孔孔隙率的血管支 架， 用于封堵动脉瘤。 背景技术 The present invention relates to an implantable device for treating vascular malformations, and more particularly to a novel vascular stent for use in the repair of a tumor-bearing artery. More specifically, it is a vascular stent having a low mesh porosity for occluding an aneurysm. Background technique
血管壁， 特别是动脉血管壁可能发生局部异常的扩张或凸起， 一般称 之为动脉瘤。 血管壁由于疾病、 损伤或先天等因素引起薄弱， 在承受血流 的冲击下， 该处动脉壁的薄弱点向外突出， 逐渐扩张， 形成圓形、 椭圓形 或菱形的嚢状膨大。 动脉瘤是一种有潜在生命危险的疾病， 动脉瘤在血流 的冲击下不断生长， 从而压迫周围器官或组织引起症状； 或者， 由于血压 增高或其他因素引起动脉瘤破裂， 进而发生急剧的出血， 而动脉瘤破裂具 有很高的致死率。 动脉瘤可发生在身体的不同部位， 最常见的腹主动脉瘤 和颅内动^瘤。 A local abnormal expansion or bulge may occur in the vessel wall, particularly the arterial vessel wall, and is generally referred to as an aneurysm. The blood vessel wall is weak due to diseases, injuries or congenital factors. Under the impact of blood flow, the weak point of the arterial wall protrudes outward and gradually expands to form a circular, elliptical or rhomboid shape. An aneurysm is a potentially life-threatening disease. An aneurysm grows under the influence of blood flow, which causes the surrounding organs or tissues to cause symptoms. Or, due to increased blood pressure or other factors, the aneurysm ruptures, and then a sharp bleeding occurs. , and aneurysm rupture has a high mortality rate. Aneurysms can occur in different parts of the body, the most common abdominal aortic aneurysms and intracranial motor tumors.
最常见的颅内动脉瘤易发生在血管分支、 分叉、 弯曲部位， 主要由于 该部位的血流动力学因素， 即轴向血流对血管远端的冲击形成剪切应力， 导致血管弹力层的破坏， 形成嚢状突起， 同时剪切应力刺激促进受损的血 管内皮细胞分裂生长， 进而生长形成动脉瘤， 这种剪切应力是动脉瘤形成 的基本原因。 形成的动脉瘤内血液发生紊乱， 形成涡流， 诱导流体共振， 引发血管壁振荡并促进其变性、 生长、 破裂。 The most common intracranial aneurysms are prone to branching, bifurcation, and bending of blood vessels, mainly due to the hemodynamic factors of the site, that is, the impact of axial blood flow on the distal end of the blood vessel to form shear stress, resulting in a resilient layer of blood vessels. The destruction, the formation of sickle-like protrusions, while shear stress stimulation promotes the division and growth of damaged vascular endothelial cells, and then grows to form an aneurysm. This shear stress is the basic cause of aneurysm formation. The blood formed in the aneurysm is disordered, forming eddy currents, inducing fluid resonance, triggering oscillation of the blood vessel wall and promoting denaturation, growth and rupture.
动脉瘤治疗的通常方法主要包括以下两种： （ 1 )外科手术夹闭动脉瘤， 例如通过开颅手术用金属夹子夹闭动脉瘤颈部。 （2)血管内介入治疗。 血管 内介入治疗具体有两种方式： 一种是利用可脱卸弹簧圈 （或微金属丝圈， 或其他栓塞材料如可解脱球嚢、 可固化液体等）栓塞动脉瘤； 另一种是植 入血管支架。 The usual methods for the treatment of aneurysms mainly include the following two types: (1) surgically clamping an aneurysm, for example, clamping the aneurysm neck with a metal clip through craniotomy. (2) Endovascular interventional therapy. There are two ways to treat endovascular interventions: one is to use a detachable coil (or micro-wire ring, or other embolic material such as detachable bulbs, curable liquid, etc.) to embolize the aneurysm; the other is implant Stent.
由于外科手术治疗存在创伤性、 高风险性及高并发症等缺陷， 而血管 内介入治疗则具有创伤小、 并发症少、 安全性高、 患者痛苦少、 易接受、 年高病情重也能耐受的优势。 因而血管内介入治疗已逐渐替代了外科手术 方法， 成为治疗动脉瘤的主要方法， 尤其是利用可脱卸弹簧圈填塞瘤腔的 血管内介入治疗方法。Because of the traumatic, high-risk and high-complication defects in surgical treatment, endovascular intervention has less trauma, less complications, high safety, less pain, easy to accept, and high-grade disease. The advantage. Therefore, endovascular intervention has gradually replaced surgery. The method is the main method for treating aneurysms, especially the intravascular interventional treatment method of filling the tumor cavity with a detachable spring coil.
利用可脱卸弹簧圈填塞瘤腔的血管内介入治疗方法是目前主要的动 脉瘤介入治疗方法。 其基本原理是通过微导管将金属弹簧圈置入动脉瘤内 以填塞动脉瘤， 使血流无法流入动脉瘤， 从而达到治疗效果。 但是该方法 在材料和技术上均存在很大缺陷， 具体如下： Intravascular interventional therapy using a detachable coil to fill the tumor cavity is currently the main interventional treatment for arteriovenous tumors. The basic principle is to place a metal coil into the aneurysm through a microcatheter to fill the aneurysm, so that blood flow can not flow into the aneurysm, thereby achieving a therapeutic effect. However, this method has great defects in materials and technology, as follows:
( 1 ) 弹簧圈须经微导管送入动脉瘤腔， 即动脉瘤填塞治疗的终端行 为发生在动脉瘤腔内。 因此， 手术中使用的金属导丝、 微导管或弹簧圈头 端极易刺破较薄的动脉瘤壁， 从而引发颅内或脑内大出血， 直接导致患者 在术中或术后死亡； (1) The coil must be delivered into the aneurysm lumen via a microcatheter, ie the terminal action of the aneurysm tamponade occurs in the aneurysm lumen. Therefore, the metal guide wire, microcatheter or coil end used in the operation is easy to pierce the thin aneurysm wall, thereby causing intracranial or intracerebral hemorrhage, which directly leads to death of the patient during or after surgery;
( 2 ) 宽基动脉瘤单纯弹簧圏填塞， 不能保证弹簧圈在瘤腔内盘曲， 极容易逸入载瘤动脉， 造成动脉主干闭塞； (2) The wide-base aneurysm is simply spring-filled, which cannot ensure that the coil is curled in the tumor cavity, and it is easy to escape into the tumor-bearing artery, causing the artery to be occluded;
( 3 ) 通常弹簧圈材料为铂， 由于铂为重金属元素。 因此， 当大动脉 瘤、 巨大动脉瘤致密填塞后， 常产生显著的占位效应， 从而使患者出现瘤 周脑组织、 重要血管和神经压迫症状； (3) Usually the coil material is platinum, since platinum is a heavy metal element. Therefore, when the large aneurysm and the large aneurysm are densely packed, it often produces a significant space-occupying effect, which causes the patient to have symptoms of peritumoral brain tissue, important blood vessels and nerve compression;
( 4 )假性动脉瘤， 瘤壁缺乏正常血管应有的平滑肌和弹力纤维等支 撑结构， 在动脉血流高压冲击下， 弹簧圈在瘤腔内难于停留或致密盘绕， 给弹簧圈的瘤腔有效填塞造成困难。 (4) pseudoaneurysm, the tumor wall lacks the supporting structure of smooth muscle and elastic fiber which should be in normal blood vessels. Under the high pressure of arterial blood flow, the coil is difficult to stay or densely coiled in the tumor cavity, giving the tumor cavity of the coil Effective filling makes it difficult.
( 5 ) 由于材料特性决定了填塞后的瘤腔内血栓机化困难， 或部分非 致密填塞， 造成病灶复发、 甚至增大。 (5) Due to the material characteristics, it is determined that the thrombus in the tumor cavity after packing is difficult to be machined, or partially non-compacted, causing recurrence or even enlargement of the lesion.
( 6 ) 手术耗时长， 费用昂贵。 (6) The operation is time consuming and expensive.
可脱卸弹簧圈填塞瘤腔的血管内介入治疗方法的以上缺陷， 给医患双 方的心理和实践都造成了消极的影响。 The above defects of the vascular detachable coil filling the tumor cavity have negatively affected both the psychology and practice of both doctors and patients.
此外， 常规的血管支架植入也被应用到动脉瘤治疗， 主要用于辅助弹 簧圈栓塞， 即支架植入后作为血管内支撑物可以防止弹簧圈突入载瘤动脉 内。 这类血管支架通常的设计特点是大网格设计以保证输送弹簧圈的微导 管可以通过网格深入动脉瘤释放弹簧圈。 该技术在一定程度上改善了弹簧 圈栓塞的缺点（如弹簧圈逸入载瘤动脉、提高宽颈、梭形动脉瘤治疗效果）， 但是该技术存在操作复杂、 难度高， 且费用 贵等诸多缺陷。 更主要的是 由于该技术也是利用金属圈栓塞瘤腔的原理来治疗血管瘤， 因此， 填塞后 的瘤腔内血栓机化困难， 或部分非致密填塞， 从而使得载瘤血管不可能实 现真正意义上的解剖治愈。 发明内容In addition, conventional vascular stent implantation has also been applied to aneurysm treatment, mainly for assisting the coil embolization, that is, as an intravascular support after the stent is implanted, the coil can be prevented from protruding into the artery. The usual design feature of this type of vascular stent is a large mesh design to ensure that the microcatheter that carries the coil can release the coil through the mesh deep into the aneurysm. This technology has improved the disadvantages of the coil embolization to some extent (such as the spring coil into the tumor-bearing artery, improving the wide neck, fusiform aneurysm treatment effect), but the technology is complicated, difficult, and expensive. defect. More importantly, because the technique also uses the principle of metal ring embolization of the tumor cavity to treat hemangiomas, therefore, after filling The intracavitary thrombosis is difficult to machine, or partially non-compactly packed, making it impossible to achieve true anatomical healing of the tumor-bearing blood vessels. Summary of the invention
本发明的血管支架是根据一种全新的治疗原理而设计， 通过选择适当 The vascular stent of the present invention is designed according to a completely new treatment principle, by selecting appropriate
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本发明提供一种网管状孔隙结构的血管支架， 其特征在于网孔孔隙率 为 40%~80%。 The invention provides a vascular stent with a mesh tubular pore structure, characterized in that the mesh porosity is 40% to 80%.
优选地， 所述网孔孔隙率为 55%〜75%。 Preferably, the mesh porosity is 55% to 75%.
所述网孔孔隙率是指非网格覆盖区域的面积与血管支架的圓柱外侧 面积、之比。 The mesh porosity refers to the ratio of the area of the non-mesh covered area to the outer area of the cylindrical side of the blood vessel stent.
本发明的网孔孔隙尺寸为 0.05mm~0.8mm。 所述的网孔孔隙尺寸的是 指非覆盖区域可通过的最大内切圓直径。 The mesh pore size of the present invention is from 0.05 mm to 0.8 mm. The pore size of the mesh refers to the maximum inscribed circle diameter through which the non-covered area can pass.
本发明的血管支架由多个圆周环状单元和连接圓周环状单元的连接 结构组成， 圓周环状单元沿着支架轴向左右排列， 左右排列的相邻圓周环 状单元通过连接结构连接。 所述连接结构可以是连接杆、 左右相邻环状单 元共有的连接点。 The blood vessel stent of the present invention is composed of a plurality of circumferential annular units and a connecting structure connecting circumferential annular units, the circumferential annular units are arranged side by side along the axial direction of the stent, and adjacent circumferential annular units arranged side by side are connected by a connecting structure. The connecting structure may be a connection point shared by the connecting rods and the left and right adjacent annular units.
所述圓周环状单元可以由主正弦波和副正弦波组成闭合网孔结构， 相 邻环状单元之间通过连接杆连接。 The circumferential annular unit may be composed of a main sine wave and a sub sine wave to form a closed mesh structure, and adjacent annular units are connected by a connecting rod.
所述圓周环状单元由四菱形闭合单元沿圓周方向排列组成， 沿圓周方 向排列的每相邻闭合单元环之间共用一个连接点， 左右排列的圆周环状单 元通过相邻闭合单元共用的连接点连接。 The circumferential annular unit is composed of a four-diamond closed unit arranged in a circumferential direction, and each adjacent closed unit ring arranged in the circumferential direction shares a connection point, and the left and right circumferential annular units are connected by a common closed unit. Point connection.
所述圓周环状单元上四菱形闭合单元的数量优选 15〜30个， 更优选 20-28个。 The number of the four-diamond closed cells on the circumferential annular unit is preferably 15 to 30, more preferably 20 to 28.
本发明的血管支架的圓周环状单元也可以由四菱形单元网孔组成， 每 相邻的四菱形单元共用一条边。 The circumferential annular unit of the blood vessel stent of the present invention may also be composed of a four-diamond unit mesh, and each adjacent four-diamond unit shares one side.
所述血管支架的材料可以是不锈钢、 钴基合金、 镍钛、 铂金、 钽、 医 用高分子材料。 The material of the blood vessel stent may be stainless steel, cobalt-based alloy, nickel titanium, platinum, rhodium, or medical polymer material.
本发明血管支架可以植入病变血管， 闭塞病变部位， 特别是闭塞动脉 瘤， 从而实现血管的修补重构和真正的解剖治愈。 相比于现有技术， 本发明具有以下优点：The vascular stent of the invention can be implanted into the diseased blood vessel, occlude the lesion site, especially the occlusion aneurysm, thereby realizing the repair and reconstruction of the blood vessel and the real anatomical cure. Compared with the prior art, the present invention has the following advantages:
( 1 ) 本发明的低孔隙率的网孔能够显著影响血流流动， 使得血流方 向改变， 速度减慢， 压力降低， 促使动脉瘤内血栓形成萎缩、 机化， 进而 使得动脉瘤可皱缩、 吸收， 明显减少压迫效应， 从而达到治疗动脉瘤的目 的。 (1) The low-porosity mesh of the present invention can significantly affect the flow of blood, so that the direction of blood flow changes, the speed is slowed, the pressure is lowered, and the thrombus formation in the aneurysm is atrophied and mechanized, thereby making the aneurysm shrinkable. , absorption, significantly reduce the oppression effect, so as to achieve the purpose of treatment of aneurysms.
( 2 ) 网孔的网丝作为内皮细胞生长或移行的支撑， 瘤颈部位的内膜 化程度与网孔大小呈负相关， 一定密集度即低孔隙率的网孔能够促使内膜 生长过程加快， 而动脉瘤内血流滞留则保障了内膜生长的物理条件， 使病 变血管内膜化实现真正的解剖治愈。 附图说明 (2) The mesh of the mesh is supported by the growth or migration of endothelial cells. The degree of intimalization of the neck is negatively correlated with the size of the mesh. A certain density, that is, a mesh with low porosity, can promote the growth process of the intima. Accelerate, and the retention of blood flow in the aneurysm guarantees the physical conditions of endometrial growth, enabling the endometrialization of the diseased vessel to achieve a true anatomical cure. DRAWINGS
图 1是本发明实施例一血管支架沿着轴向展开的示意图； 1 is a schematic view of a blood vessel stent deployed along an axial direction according to an embodiment of the present invention;
图 2是本发明实施例二血管支架沿着轴向展开的示意图； 2 is a schematic view showing the deployment of the blood vessel stent along the axial direction according to the embodiment of the present invention;
图 3是本发明实施例三血管支架沿着轴向展开的示意图； 具体实施方式 3 is a schematic view of the three-vessel stent of the embodiment of the present invention deployed along the axial direction;
下面结合附图对本发明的具体实施方式进行说明。 Specific embodiments of the present invention will be described below with reference to the accompanying drawings.
结合图 1所示， 本实施例一的网管状孔隙结构的血管支架， 由多个圓 周环状单元 11和连接圓周环状单元的连接杆 12组成， 圓周环状单元 11 沿着支架轴向左右排列， 左右排列的相邻圓周环状单元 11通过连接杆 12 连接， 圓周环状单元 11 由主正弦波 13和副正弦波 14组成闭合网孔结构 15 , 主正弦波 13比副正弦波 14粗， 血管支架的孔隙率为 78%。 As shown in FIG. 1, the stent of the mesh tubular structure of the first embodiment is composed of a plurality of circumferential annular units 11 and connecting rods 12 connecting circumferential annular units, and the circumferential annular unit 11 is axially arranged along the axial direction of the stent. Arranged, the adjacent circumferential annular units 11 arranged side by side are connected by a connecting rod 12, and the circumferential annular unit 11 is composed of a main sine wave 13 and a sub sine wave 14 to form a closed mesh structure 15, and the main sine wave 13 is thicker than the sub sine wave 14 The porosity of the vascular stent is 78%.
结合图 2所示， 本实施例二的网管状孔隙结构的血管支架， 由多个圓 周环状单元 21和连接相邻圓周环状单元的连接点 22组成， 圓周环状单元 21沿着支架轴向左右排列， 左右排列的圓周环状单元 21通过相邻闭合单 元共用的连接点 22连接， 圓周环状单元 21 由多个四菱形闭合单元 25沿 着圓周方向排列组成， 沿圓周方向排列的相邻闭合单元环之间共用一个连 接点 24 , 血管支架的孔隙率为 70%。 As shown in FIG. 2, the stent of the mesh tubular structure of the second embodiment is composed of a plurality of circumferential annular units 21 and connecting points 22 connecting adjacent circumferential annular units, and the circumferential annular unit 21 is along the stent axis. Arranged to the left and right, the circumferential annular unit 21 arranged side by side is connected by a joint point 22 shared by adjacent closing units, and the circumferential annular unit 21 is composed of a plurality of four-diamond closing units 25 arranged in the circumferential direction, and the phases arranged in the circumferential direction are arranged. A junction point 24 is shared between adjacent closed cell rings, and the porosity of the vascular stent is 70%.
进一步， 圓周环状单元上四菱形闭合单元数量为 15〜30个。 Further, the number of four-diamond closed cells on the circumferential annular unit is 15 to 30.
更进一步， 圓周环状单元上四菱形闭合单元数量为 20〜28个。 结合图 3所示， 本实施例三的网管状孔隙结构的血管支架， 由多个圓 周环状单元 31组成， 圓周环状单元 31沿着支架轴向左右排列， 圓周环状 单元由四菱形单元网孔 35组成， 每相邻的四菱形单元共用一条边 32 , 血 管支架的孔隙率为 50%。Furthermore, the number of four-diamond closed cells on the circumferential annular unit is 20 to 28. As shown in FIG. 3, the vascular stent of the mesh tubular structure of the third embodiment is composed of a plurality of circumferential annular units 31, and the circumferential annular unit 31 is arranged side by side along the axial direction of the stent, and the circumferential annular unit is composed of a quadrangular unit. The mesh 35 is composed of a side 32 of each adjacent four-diamond unit, and the porosity of the blood vessel stent is 50%.