CN104287870A - Tubular cavity stent - Google Patents

Tubular cavity stent Download PDF

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CN104287870A
CN104287870A CN201410532215.8A CN201410532215A CN104287870A CN 104287870 A CN104287870 A CN 104287870A CN 201410532215 A CN201410532215 A CN 201410532215A CN 104287870 A CN104287870 A CN 104287870A
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waveform
stent
proximal
ring
distal
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CN201410532215.8A
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CN104287870B (en
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王永胜
郭伟
李建民
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先健科技(深圳)有限公司
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Abstract

The invention discloses a tubular cavity stent which comprises a bare stent section and a covered stent section connected with the bare stent section. The bare stent section comprises at least two coaxial wave-shaped annuluses and rigid connecting parts and further comprises non-elastic flexible connecting parts capable of being optionally bent, wherein every two wave-shaped annuluses of at least two coaxial wave-shaped annuluses are connected through the corresponding rigid connecting part and the corresponding flexible connecting part, the rigid connecting parts and the flexible connecting parts are arranged in the circumferential direction in a mixed mode, and the length of each flexible connecting part is slightly greater than the shortest separation distance between every two wave-shaped annuluses. The flexibility of the tubular cavity stent can be improved, and the axial connecting strength of the tubular cavity stent can be kept.

Description

管腔支架 Luminal stent

技术领域 FIELD

[0001] 本发明属于医疗器械技术领域,涉及一种管腔内的支架,尤其涉及一种用于主动脉中的管腔支架。 [0001] The present invention belongs to the technical field of medical instruments, relates to a stent within a lumen, and particularly to a stent for a lumen of the aorta.

背景技术 Background technique

[0002] 在主动脉疾病中,主要包括主动脉夹层和主动脉瘤两类疾病;主动脉瘤进一步分为主动脉真性动脉瘤和主动脉假性动脉瘤。 [0002] In aortic diseases, including two types of aortic dissection and aortic aneurysm disease; aortic aneurysm is further divided into true aneurysm and aortic pseudoaneurysm. 主动脉瘤和主动脉夹层是一种极为凶险的疾病,发病后48小时内的死亡率大于50%,两周内的死亡率大于85%,已经严重威胁人类健康。 Aortic aneurysms and aortic dissection is a very dangerous disease, the mortality rate within 48 hours of the onset of greater than 50% mortality rate greater than 85% within two weeks, has been a serious threat to human health. 随着中国老龄化趋势的到来,其发病率将不断攀升。 With the arrival of China's aging trend, the incidence rate will continue to rise.

[0003] 在主动脉瘤患者中,腹主动脉瘤患者占主动脉瘤患病率的63%〜79%,而且多发生于60岁以上的老年人群,发病率达2%〜4%,男性多于女性,在所有导致死亡的原因中排在第13位。 [0003] In patients with aortic aneurysm, abdominal aortic aneurysm patients accounted for 63% ~79% prevalence of aortic aneurysms, but also occurs in the elderly population over the age of 60, the incidence rate of 2% ~ 4% for men than women, ranked No. 13 in all-cause death. 如图la、Ib所示,大多数腹主动脉瘤4系动脉粥样硬化所引起,一般位于肾动脉2的远端(在植入领域,通常定义血液从近端流向远端,血液流向如图la、lb中箭头所示),延伸至腹主动脉分叉处,常波及髂动脉5、偶尔位于肾动脉2以上部位;一旦病人腹主动脉瘤4破裂,死亡率高达50 %〜80 %,是一种及其凶险的疾病,所以在腹主动脉破裂前进行干预性治疗具有十分重要的意义。 FIG La, shown most abdominal aortic aneurysm 4 lines caused by atherosclerosis Ib, typically in the renal artery of the distal end 2 (in the field of implantable, distal blood flow is generally defined from the proximal end, such as blood flow FIG la, lb as shown by an arrow), extends to the bifurcation of the abdominal aorta, iliac arteries often spread to 5, and occasionally in the renal artery 2 or more parts; 4 Once a patient ruptured abdominal aortic aneurysm, the mortality rate as high as 50% ~ 80% , and it is a dangerous disease, so treatment before the intervention of abdominal aortic rupture has great significance.

[0004] 在微创介入治疗主动脉疾病的过程中,通常利用腔内隔绝原理,即腔内修复术(endovascular aneurysm repair, EVAR),采用覆膜支架隔绝血流与主动脉瘤或主动脉夹层。 [0004] In the process of minimally invasive treatment of aortic disease, typically utilize isolated cavity principle, i.e. endovascular repair (endovascular aneurysm repair, EVAR), isolated from blood using the stent graft and aortic aneurysm or aortic dissection . 目前业内的主动脉覆膜支架主要由金属丝及覆盖在其上的PET(聚对苯二甲酸乙二醇酯树脂)膜或ePTFE(聚四氟乙烯)膜组成,金属丝制成圆筒形支架骨架,其上覆盖PET膜或ePTFE膜。 Industry's aortic stent graft and a cover mainly of a metal wire on which a PET (polyethylene terephthalate resin) film or the ePTFE (polytetrafluoroethylene) film composition, a metal wire into a cylindrical shape stent scaffold, which is covered with a PET film or the ePTFE membrane.

[0005] 用于治疗主动脉瘤的大多数管腔支架包括覆膜支架段、以及与该覆膜支架段连通相连的裸支架段,覆膜支架段用于隔绝血流与主动脉瘤或主动脉夹层,裸支架段用于提高支架近端的贴壁性及主动脉血管覆膜支架近端的支撑锚定性能,防止覆膜支架段的移位及支架近端术中、术后I型内漏,对于用于腹主动脉的支架而言,裸支架段同时可避免切断流入肾动脉的血流。 Most intraluminal scaffold [0005] for the treatment of aortic aneurysm stent graft segment comprises, as well as the bare stent segment communicating with the stent-graft segment attached to the stent graft segment is used to isolate the main blood flow or aortic aneurysm dissection, the bare stent segment support for improving the anchoring properties of adherent vascular stent graft and the proximal end of the proximal end of the aortic stent, and the stent to prevent proximal displacement of the stent-graft segment surgery, postoperative type I endoleaks, to the support for the abdominal aorta, the bare stent segment while avoiding off blood flow into the renal arteries.

[0006] 如图la、Ib所示以腹主动脉瘤为例,图1a为近端锚定区形态较好的情形、图1b为近端锚定区形态较差的情形,EVAR手术对近端锚定区形态有一定的要求,要求近端瘤颈长度H(是指瘤体近端与较近肾动脉之间的正常主动脉段长度)> 15_,现在由于支架的改进和技术的提高,可以将近端瘤颈长度放宽到HS 1mm;近端肾上瘤颈角度α (指近端瘤颈中轴线与肾上腹主动脉主干中轴线之间夹角)应< 60°,肾下瘤颈角度β (指近端瘤颈中轴线与瘤腔中轴线之间夹角)应<70°。 [0006] FIG La, abdominal aortic aneurysm Ib shown as an example, FIG. 1a is a proximal anchoring region preferably form a given situation, Figure 1b is a poor morphology case proximal anchor region, near surgery of EVAR terminal anchor region morphology certain demands to the proximal aneurysm neck length H (refer to tumor near the proximal end of the normal aorta between the renal arteries length)> 15_, now due to increased and improved technology of the stent , the length of the proximal aneurysm neck to the HS 1mm can be relaxed; the renal proximal aneurysm neck angle [alpha] (refer to the angle between the axis of the proximal aneurysm neck renal abdominal aorta trunk axis) should be <60 °, renal aneurysm neck angle beta] (refer to the angle between the axis of the proximal aneurysm neck tumor cavity axis) should be <70 °. 瘤颈越短,可供覆膜支架锚定的区域就越小,术中、术后发生近端I型内漏、移植物移位等并发症的概率就越高。 The shorter the aneurysm neck, the smaller the stent-graft for anchoring region, surgery, type I endoleak postoperative proximal end, the probability of complications like graft shifted higher. 瘤颈角度越大,就需要柔顺性越好的支架来适应。 The larger the aneurysm neck angle, we need better flexibility of the stent to adapt. 目前业内解决这一问题的一种技术为近端裸支架跨肾动脉技术,将覆膜支架血管的近端裸支架跨肾动脉释放,适用的裸支架分为不带锚刺裸支架和带锚刺裸支架两类。 Currently a technology industry to solve this problem is proximal bare stent technology across the renal arteries, the renal artery proximal stent graft across the vessels of the bare stent release for the bare stent into a bare stent without thorns and anchor with anchor thorn bare stent types. 不带锚刺裸支架多为单圈波形环状物,呈圆柱形或喇叭口状,临床主要应用于近端瘤颈长度大于15mm,瘤颈形态规则,能够为其提供一个良好着陆区域的情形,但此类裸支架因其仅靠周向作用力与血管内壁贴合,有锚定性差的缺点,在手术过程或手术后期还是比较容易出现移位现象。 Without barbed anchor bare stent than a single waveforms ring coil, cylindrical or toroidal, applied to the proximal end of the main clinical aneurysm neck lengths greater than 15mm, neck aneurysm morphology rules, it is possible to provide a good landing zone case , but such bare-metal stents because of their week alone fit to force the blood vessel wall, there are disadvantages anchor qualitative difference, it is quite easy to shift phenomenon occurs during surgery or post-surgery.

[0007] 对于瘤颈较短(1mm < H < 14mm之间)的病例,通常采用带锚刺裸支架进行肾上固定,锚刺结构扎入血管壁内,可以稳固的固定住支架,防止支架远期的移位,此种设计较不带锚刺裸支架拓宽了腹主动脉瘤腔内治疗的适应范围。 [0007] For short neck tumors (<H <between 1mm 14mm) cases, usually with a barbed anchor is fixed on the bare stent kidney, gill structure anchor bar into the vessel wall, the stent can be fixed securely to prevent the stent forward displacement, this design is less barbed anchor with a bare stent to adapt to broaden the range of endovascular abdominal aortic aneurysm treatment. 带锚刺裸支架根据其基本组成结构又可分为单圈结构与多圈结构(目前业内一般为两圈),其中单圈结构为一圈设有锚刺的波形环状物,应用于临床复杂弯曲血管解剖形态,当支架释放后,因其轴向长度较短,裸支架会出现一侧锚刺过度贴服血管壁,另一侧锚刺与血管壁分离而悬空的状态,从而影响其锚定性能。 The barbed anchor with a bare stent structure consisting essentially of a single ring structure and can be divided into multiple ring structures (currently the industry typically twice), wherein the lap anchor structure is a circle with an annular stab waveform was applied to clinical complex curved vascular anatomy, when the stent is released, its axial length is short, there will be a side of the bare stent anchoring thorns stick take over the vessel wall, the other side of the anchor to the vessel wall puncture separated suspended state, thus affecting its anchoring performance.

[0008] 具有多圈波形环状物的多圈结构可避免上述缺点,但相邻波形环状物之间的连接则会带来新的问题,目前相邻圈波形环状物之间通过刚性连接件连接在一起,例如相邻的波形环状物中,其中一个波形环状物的远端顶点与另一个波形环状物中的近端顶点均连接有金属细杆,此刚性连接方式增加了裸支架的整体连接刚度,避免了支架短缩,但造成其柔顺性比较差的问题,裸支架很难适应血管角度的变化,植入后会给血管壁长期施加较大的应力,加大了并发症的发生概率。 [0008] The multi-turn coil structure having a plurality of waveform annulus above drawbacks can be avoided, but the connection between the adjacent waveforms ring will bring new problems, between adjacent turns of the current waveform by a rigid ring connecting member are connected together, for example in the annulus adjacent the waveform, wherein the distal end of the proximal apex ring vertex and another waveform in a waveform ring are connected with a thin metal rod, rigidly connected in this manner to increase the overall stiffness of the connection of bare-metal stents, stent avoid shortening, but the cause of its relatively poor compliance issues, bare-metal stents is difficult to adapt to changes in the vascular angle, long-term large stress is applied will give the vessel wall after implantation, to increase the probability of occurrence of complications.

发明内容 SUMMARY

[0009] 本发明要解决的技术问题在于,针对现有技术中上述的缺陷,提供一种能提高支架柔顺性并保持支架轴向连接强度的管腔支架。 [0009] The present invention is to solve the technical problem, the prior art for the above drawbacks, to provide an improved compliant stent lumen of the stent and hold the stent axially connecting strength.

[0010] 本发明解决其技术问题所采用的技术方案是:一种管腔支架,包括裸支架段和与所述裸支架段相连的覆膜支架段,所述裸支架段包括至少两个同轴的波形环状物和刚性连接件,所述裸支架段还包括无弹性并可任意弯曲的软性连接件,所述至少两个波形环状物中每相邻的两个波形环状物通过所述刚性连接件和所述软性连接件连接,在周向上所述刚性连接件与所述软性连接件混合排布,所述软性连接件的长度略大于两个波形环状物之间的最短间距。 [0010] aspect of the present invention to solve the technical problem is: A luminal stent comprising a stent graft and a bare stent segment segment and the segment connected to the bare stent, the bare stent segment comprises at least two different waveform and the ring member rigidly connected to the shaft, the bare stent segment further comprises an inelastic flexible connection can arbitrarily curved member, said at least two waveforms in each adjacent ring collar two waveforms rigidly connected to said connector and via the flexible connection member, said connecting member circumferentially rigid flexible connection member to the mixing arrangement, the length of the flexible connection member is slightly larger than the two waveforms ring the shortest distance between.

[0011] 每个所述波形环状物包括多个连续首尾相接形成波形的支撑部,所有的支撑部位于同一个圆柱面上、关于中轴线轴对称设置,多个支撑部首尾连接处形成多个近端顶点和多个远端顶点;相邻的两个波形环状物中的一个波形环状物的一个近端顶点与另一个波形环状物的一个远端顶点通过刚性连接件或软性连接件连接。 [0011] each of said waveform comprises a plurality of successive annular end to end to form a support portion of the waveform, all of the support portion in the same cylindrical surface, the bobbin symmetrically disposed about a central axis, are formed at a plurality of supporting portions connected end to end a distal plurality of vertices and a plurality of proximal apex; a distal end and a proximal apex another waveform ring adjacent two waveforms in a waveform annulus ring vertices or through a rigid connecting member flexible connection member is connected.

[0012] 所述至少两个波形环状物包括近端波形环状物和远端波形环状物,相邻的近端波形环状物和远端波形环状物之间的波形相位异步;或者近端波形环状物的波宽大于远端波形环状物的波宽。 [0012] waveforms of the at least two waveform comprises a proximal collar and a distal collar ring waveforms, the waveform between adjacent proximal and distal ring wave waveform phase asynchronous ring; wave or waveforms proximal annulus wider than the distal end of the wave waveform ring width.

[0013] 所述刚性连接件与所述软性连接件交错排布。 [0013] The connecting member rigidly connected to said flexible member staggered arrangement.

[0014] 所述波形环状物和所述刚性连接件为一体成型的结构。 The [0014] waveforms ring and said rigid connecting member is integrally formed structure.

[0015] 所述刚性连接件相对于所述裸支架段的中轴线倾斜设置、且位于在同一圆柱面上。 The [0015] connection member rigidly with respect to the bare stent segment disposed inclined to the axis and located on the same cylindrical surface.

[0016] 所述刚性连接件与所述裸支架段中轴线垂直的圆周线的夹角δ为20。 The [0016] element is rigidly connected to the angle δ in the bare stent segments perpendicular to the axis 20 of the circumferential line. 〜45°。 ~45 °.

[0017] 各波形环状物均设有用于固定所述软性连接件的连接孔。 [0017] Each waveform has a ring for fixing said flexible connection member connecting hole.

[0018] 所述软性连接件为单股具有高拉伸强度的、与人体相容的丝线;或者所述软性连接件为一种或多种丝线经多股混纺的混合线。 [0018] The flexible connection member is a single strand of high tensile strength wires are compatible with the human body; or the flexible connection member is one or more multi-strand wire was blended hybrid wire.

[0019] 所述丝线由高分子材料制成,所述高分子材料包括PE、PTFE、PET和PP中的至少一种。 [0019] The wire is made of a polymeric material, the polymeric material comprises PE, PTFE, at least one of PET and PP.

[0020] 所述波形环状物包括与相邻波形环状物无连接的至少一组悬空近端顶点和/或至少一组悬空远端顶点,每组悬空近端顶点包括I个悬空近端顶点或2个相邻的悬空近端顶点,每组悬空远端顶点包括I个悬空远端顶点或2个相邻的悬空远端顶点。 [0020] The waveform comprises a ring and / or at least one group of floating distal apex, each proximal apex comprising floating suspended proximal end of the I floating at least one set of the waveform of the proximal apex adjacent ring connectionless or two adjacent vertices vacant proximal apex, the distal end of each dangling vertex I comprises a floating distal apex or 2 adjacent the distal end dangling vertex.

[0021] 所述刚性连接件在裸支架段的轴向上呈螺旋状或者直线排布;和/或所述软性连接件在裸支架段的轴向上呈螺旋状或者直线排布。 [0021] The rigid connection of the bare stent segment in the axial direction or spirally arranged linearly; and / or said flexible connection member helically or linearly in the axial direction of the bare stent segment arrangement.

[0022] 所述裸支架段的近端顶部设有锚刺,所述锚刺件朝向裸支架段的远端。 [0022] The top section is provided with a proximal bare stent anchoring thorn, the thorn anchor member toward a distal bare stent segment.

[0023] 本发明的管腔支架中,裸支架段的相邻波形环状物之间除了通过刚性连接件连接外,还采用软性连接件连接。 [0023] The luminal stent according to the present invention, the waveform between adjacent ring segments in addition to the bare stent through the outer rigid connection member is connected, using flexible connection member is also connected. 由于软性连接件无弹性、可以任意弯曲,刚性连接和软性连接并存,在满足管腔支架轴向拉伸强度和防止短缩的基础上,软性连接件的使用,增加了管腔支架的弯曲顺应性,同时也可确保支架整体轴向的连接强度。 Since the inelastic flexible connection member, can be bent, and the flexible connection is rigidly connected to coexist, without taking the axial lumen of the stent and to prevent shortening of the tensile strength, the use of flexible connection member, increasing the lumen of the stent bending compliance, and also ensure the connection strength of the entire axial stent.

附图说明 BRIEF DESCRIPTION

[0024] 下面将结合附图及实施例对本发明作进一步说明,附图中: [0024] The accompanying drawings and the following embodiments of the present invention is further illustrated drawings in which:

[0025] 图1a为近端锚定区形态规范的肾下型腹主动脉瘤示意图; [0025] Figure 1a is a schematic view of the proximal anchor Tumor Morphology specification infrarenal abdominal aorta;

[0026] 图1b为相对图1a的近端锚定区形态相对不规范的肾下型腹主动脉瘤示意图; [0026] FIG. 1a 1b proximal anchor relative to FIG Morphology relatively standard infrarenal abdominal aortic aneurysm schematic;

[0027] 图2为本发明管腔支架结构示意图; [0027] FIG. 2 is a schematic view of the invention lumen of the stent structure;

[0028] 图3为裸支架段第一种实施方式的结构示意图; [0028] FIG. 3 is a schematic view of the bare stent segment of a first embodiment;

[0029] 图4为图3裸支架段的平面展开图; [0029] FIG. 4 is a planar development view of FIG. 3 of the bare stent segment;

[0030] 图5a、5b为图4中的局部示意图; [0030] Figures 5a, 5b is a partial schematic view in FIG 4;

[0031] 图6为图4中的局部示意图; [0031] FIG. 6 is a partial schematic view in FIG 4;

[0032] 图7为图2中管腔支架释放到腹主动脉后的示意图; [0032] FIG. 7 is a schematic view of the abdominal aorta in FIG. 2 released into the lumen of the stent;

[0033] 图8为第二种实施方式的裸支架段结构示意图; [0033] FIG. 8 is a schematic configuration of the bare stent segment to the second embodiment;

[0034] 图9为图8裸支架段的平面展开图; [0034] FIG 9 is a planar development view of the bare stent segment of FIG. 8;

[0035] 图10为图9中的局部示意图; [0035] FIG. 10 is a partial schematic view of FIG 9;

[0036] 图11为图9中裸支架段与主体覆膜支架连接示意图; [0036] FIG. 11 is a bare stent section connected to the body 9 a schematic view of the stent graft;

[0037] 图12为图11中管腔支架释放到腹主动脉后的示意图; [0037] FIG. 12 is a schematic view of the aortic lumen of the stent in FIG. 11 to release;

[0038] 图13为裸支架段第三种实施方式的结构示意图; [0038] FIG. 13 is a schematic view of the bare stent segment to the third embodiment;

[0039] 图14为图13实施例裸支架的平面展开图; [0039] FIG 14 FIG 13 is a planar bare stent embodiment of FIG expanded embodiment;

[0040] 图15为裸支架段第四种实施方式的结构示意图; [0040] FIG. 15 is a schematic view of the bare stent segment of the fourth embodiment;

[0041] 图16为图15实施例裸支架的平面展开图。 [0041] FIG. 16 is a planar development view bare stent embodiment of FIG. 15 embodiment.

具体实施方式 Detailed ways

[0042] 为了对本发明的技术特征、目的和效果有更加清楚的理解,现对照附图,以腹主动脉支架为例来详细说明本发明的具体实施方式。 [0042] For the technical characteristics of the invention, the objects and effects more clearly understood, reference to the drawings now, embodiments of the present invention in the abdominal aortic stent will be described in detail as an example. 本领域的普通技术人员应当知晓,该腹主动脉支架仅用作举例,并不对本发明的限制,本发明的管腔支架为任意的带裸支架的覆膜管腔支架,包括但不限于腹主动脉支架,还包括胸主动脉支架、髂动脉支架等。 Those of ordinary skill in the art should be aware, the abdominal aortic stent way of example only, not limitation of the invention, the lumen of the stent of the present invention is arbitrary covered with bare stent lumen of the stent, including but not limited to abdominal aortic stent, the stent further comprising thoracic aorta, iliac stents.

[0043] 方位定义:本发明根据血液流向定义方位,即血液从近端流向远端。 [0043] orientation is defined: The blood flow to the definition of the present invention, the orientation, i.e., blood flow distal from the proximal end.

[0044] 如图2所示,一种管腔支架,包括裸支架段10和与裸支架段10相连的覆膜支架段20,裸支架段10包括至少两个同轴的波形环状物100和刚性连接件130,裸支架段10还包括无弹性并可任意弯曲的软性连接件131,至少两个波形环状物100中每相邻的两个波形环状物100通过刚性连接件130和软性连接件131连接,在周向上刚性连接件130与软性连接件131混合排布,软性连接件131的长度略大于两个波形环状物100之间的最短间距。 [0044] 2 An intraluminal stent, comprising a bare stent and a stent graft segment section 10 connected to the bare stent segment 1020, the bare stent segment 10 includes at least two coaxial ring waveforms 100 and a rigid connecting member 130, the bare stent 10 further comprises an inelastic segment can arbitrarily curved flexible connection member 131, collar 100 at least two waveforms in each adjacent two waveforms 100 through a rigid ring member 130 is connected and a flexible connection member 131 is connected, in the circumferential direction is rigidly connected to the flexible member 130 connecting member 131 hybrid arrangement, the length of the flexible connection member 131 is slightly greater than the shortest distance between the two waveforms 100 annulus.

[0045] 如图2所示,管腔支架中的覆膜支架段20包括覆膜201和金属骨架202,金属骨架202可以采用生物相容的SM(应力诱发马氏体)合金制成,例如镍钛合金,其形状也可是多个轴向设置的波形环状物,覆膜201经过热处理贴覆或缝合的方式与金属骨架202连接为一体。 [0045] As illustrated, the stent graft in the lumen of the stent segment 202 comprises a metal frame 202 and the film 201, the metal skeleton 202 may be employed biocompatible SM (stress-induced martensitic) an alloy, e.g. nitinol, a shape may also be provided a plurality of axially cyclic waveform was heat-treated film 201 is pasted or stitched to the metal skeleton 202 is integrally connected. 覆膜支架段20的具体结构跟现有技术中其它覆膜支架段没有区别,在此不再赘述。 A specific configuration of stent-graft segment 20 with other prior art stent-graft segment is not distinction, are not repeated here. 本实施例中金属骨架202为镍钛丝编织或镍钛管切割定型而成的正弦波形轴向设置。 In the present embodiment the metal skeleton of embodiment 202 or a nickel titanium wire braided nitinol tube cutting stereotypes axially sinusoidal waveform. 覆膜201为PFFE(聚四氟乙烯,Polytetrafluoroethylene)或PET(聚对苯二甲酸乙二醇酯,Polythylene terephthalate)材料,经过热处理贴覆或缝合的方式与金属骨架202连接为一体。 Film 201 is PFFE (PTFE, Polytetrafluoroethylene) or PET (polyethylene terephthalate, Polythylene terephthalate) material, heat treated or coated suture attached to the metal skeleton 202 is integrally connected.

[0046] 管腔支架中的裸支架段10在覆膜支架段20近端设置,裸支架段10的远端与覆膜支架段20近端的覆膜缝合在一起。 [0046] The bare stent 10 segment of the stent in the lumen of the proximal stent-graft segment 20 is provided, proximal end 20 and a distal section of the stent graft coating bare stent segment 10 are sewn together. 裸支架段10包括至少两个同轴的波形环状物100,其中同轴是指在裸支架段10和覆膜支架段20都设置在管腔支架的轴向上,二者有一个共同的中轴线,裸支架段10的至少两个波形环状物100都关于该中轴线对称设置。 A bare stent segment 10 includes at least two coaxial ring waveforms 100, wherein the means 10 and is coaxially covered stent segment bare stent section 20 are disposed in the axial lumen of the stent, the two have a common axis, at least two waveforms bare stent segment 100 of the collar 10 are symmetrically disposed about the axis. 这些波形环状物100具有相同或相似的波形形状,例如,波形环状物100可以是Z形波、V形波或正弦波等。 The collar 100 has the same waveform or a similar waveform shape, for example, waveform 100 may be a ring like Z-wave, V-shaped or sine wave. 波形环状物100、刚性连接件130可以各自单独成型,然后通过焊接、粘接等方式连接在一起,也可以波形环状物100和刚性连接件130为一体成型的制成裸支架段10,例如采用镍钛管整体切割,并采用模具经过多步热定型而成一个裸支架段10。 Waveform ring 100, a rigid connecting member 130 may be formed individually and then joined together by welding, bonding or the like, the waveform may be ring 100 and the rigid connecting member 130 integrally molded section 10 made of a bare stent, for example, nickel titanium whole cut tube, and through the use of a mold formed by a multi-stage heat setting section 10 of the bare stent. 采用的镍钛管的直径可以根据具体放置位置的血管内径而定,例如镍钛管直径为5_。 Diameter nickel-titanium tubes employed may depend on the specific placement of the vessel diameter, such as a nickel titanium tube diameter 5_.

[0047] 每个波形环状物100包括多个连续首尾相接形成波形的支撑部112,所有的支撑部112位于同一个圆柱面上、关于中轴线轴对称设置,即波形环状物100形成圆柱状结构。 [0047] Each collar 100 includes a plurality of waveform end to end support portion 112 continuous wave formed, all of the support portion 112 in the same cylindrical surface, the bobbin symmetrically disposed about a central axis, i.e., the waveform collar 100 is formed cylindrical structure. 多个支撑部112首尾连接处形成多个近端顶点和多个远端顶点;这些近端顶点是整个波形中的波峰,远端顶点是整个波形中的波谷。 A plurality of end to end of the support portion 112 are formed a plurality of vertices and a plurality of proximal distal apex; proximal apices of these peaks in the entire waveform, the distal end of the entire waveform vertex trough. 相邻的两个波形环状物100中的一个波形环状物100的一个近端顶点与另一个波形环状物100的一个远端顶点通过刚性连接件130或软性连接件131连接。 A distal end 100 of the adjacent two waveform a waveform ring collar and a proximal apex 100 of another waveform 100 of ring vertices 131 connected by a rigid connecting member 130 or flexible connection member. 在周向上,刚性连接件130和软性连接件131混合排布,即刚性连接件130和软性连接件131的排布都不是集中设置,并且在某一位置上刚性连接件130和软性连接件131的连接是择一的,即采用刚性连接件130连接的位置不会再连接软性连接件131,采用软性连接件131的位置不同时选择刚性连接件130连接。 In the circumferential direction, a rigid connecting member 130 and the flexible connection member 131 hybrid arrangement, i.e. rigid connection member 130 and the flexible connection member 131 is not centralized arrangement is provided, and the rigid connecting member 130 and flexible in a position connecting member 131 is connected to the alternative, which uses rigid connection member 130 connected position will no longer flexible connection member 131 is connected, using the position of the flexible connection member 131 is not rigidly connected to simultaneously selected connection 130. 这样,在周向上刚性连接件130中间掺杂有软性连接件131,就能降低刚性连接件130的整体弯曲刚度,增加管腔支架的柔顺性。 Thus, in the circumferential direction is rigidly connected to the intermediate member 130 is doped with a flexible connection member 131, can reduce the overall bending stiffness of the rigid connecting member 130, and increase the flexibility of the luminal stent.

[0048] 刚性连接件130是指具有一定硬度和弯曲顺应性的连接件,刚性连接件130同时具有支撑功能和连接功能的连接件。 [0048] The rigid connection 130 is a connection and a curved member having a certain hardness compliant connector, a rigid connecting member 130 also has a support function and a connection function. 刚性连接件130的刚性可避免支架短缩和提供支架整体轴向上的连接强度,同时还保证了管腔支架整体具有一定的弯曲顺应性。 Rigid connection rigid to avoid shortening the stent 130 and provide the connection strength of the entire axial stent, but also to ensure the lumen of the stent as a whole has a certain bending compliance. 软性连接件131为无弹性、无拉伸变形、可任意弯曲的连接件,因此软性连接件131主要具有连接约束功能,即对波形环状物100的近端顶点和远端顶点起到约束的作用,在管腔支架弯曲过程中,由于软性连接件131的长度略大于两个波形环状物100之间的最短间距,软性连接件131约束波形环状物100的近端顶点和远端顶点随着弯曲发生顺应弯曲变形,增加了整个管腔支架的柔顺性,以避免相对尖锐的近端顶点和远端顶点刺入血管壁,对血管产生损伤。 Inelastic flexible connection member 131, no tensile deformation, the connecting member can be bent, thus having a flexible connection member 131 connected to the main constraint function, i.e., the waveform of the proximal apex and distal apex ring 100 functions constraint effects, the bending process in the lumen of the stent, since the length of the flexible connecting member 131 is slightly larger than two waveforms shortest distance between the proximal ring 100, the flexible connecting member 131 constrained waveform ring vertices 100 and a distal end with vertices conform to bending of the bending deformation, increasing the flexibility of the entire lumen of the stent, to avoid the relatively sharp proximal and distal apices pierce the vessel wall, vascular damaged.

[0049] 在刚性连接件130和软性连接件131的混合排布中优选在周向上刚性连接件130与软性连接件131交错排布。 [0049] In the connecting member 130 and a rigid flexible connection member 131 is preferably arranged upwardly mixed rigid connection member 130 is connected to the flexible cross member 131 arranged in the circumferential direction. 交错排布是指刚性连接件130中有规律的掺杂软性连接件131,例如周向上间隔一个或多个刚性连接件130就设置有软性连接件131,软性连接件131可以连续设置一个或多个,一般刚性连接件130和软性连接件131的连续设置数量不多于三个,避免局部刚性过强或刚性过弱。 Interleaving means arranged in a rigid connecting member 130 at regular doping flexible connection member 131, for example, one or more of circumferentially spaced rigid members 130 connected to the connection member 131 is provided with a soft, flexible connection member 131 may be continuously provided one or more, generally rigid connecting member 130 and the flexible connection member 131 provided continuously number is not more than three, to avoid excessive local rigid or rigid too weak.

[0050] 刚性连接件130整体上为柱状或杆状结构,其形状可以是多种,例如直线形、弧形、曲线形等,其截面形状可以为圆形、椭圆形、倒角后的方形或其他无尖锐拐角的无规则形状等,直径或宽度跟支撑部112 —致。 [0050] member 130 is rigidly connected to the rod-like or columnar structure overall, which may be of various shapes, for example rectilinear, curved, curvilinear, etc., which may be a square cross-sectional shape of the circular, oval, chamfers no sharp corners or other irregular shape, the diameter or width of the heel support 112 - to. 刚性连接件130的材料为生物相容性金属,或其他可以用于管腔支架的材料制成。 Material rigid connecting member 130 is a biocompatible metal or other material for the lumen of the stent may be made. 本实施例中优选镍钛合金材料。 Preferred embodiments of the present embodiment Nitinol material.

[0051] 各个波形环状物100的波形可以相同也可以不同,波峰宽度可以相同也可以不同,则使得刚性连接件130的取向设置相对于管腔支架的中轴线有不同,例如:相对于中轴线平行设置、相对于中轴线倾斜设置,其中有些刚性连接件130相对于裸支架段10的中轴线倾斜设置、且位于在同一圆柱面上。 [0051] waveforms of various waveforms ring 100 may be the same or different, the peak width may be the same or different, such that the orientation of the rigid connection member 130 is provided with respect to the axis of the lumen of the stent are different, for example: the relative axes disposed in parallel, inclined with respect to the central axis, wherein some of the rigid connecting member 130 disposed obliquely with respect to the central axis of the bare stent segment 10, and located on the same cylindrical surface. 刚性连接件130相对于中轴线的倾斜方向受到限制,限定在同一圆柱面上倾斜,而不是向内或向外倾斜。 A rigid connecting member 130 is restricted with respect to the inclination direction of the central axis of the cylindrical surface defining the same inclination, instead of inward or outward. 优选刚性连接件130的倾斜角度为:刚性连接件130与裸支架段10中轴线垂直的圆周线的夹角δ为20°〜45°。 A rigid connecting member 130 is preferably inclined angle: a rigid connecting member 130 and the bare stent segment in an angle δ circumferential line perpendicular to the axis 10 is 20 ° ~45 °. 相对于平行于中轴线设置的刚性连接件130,倾斜设置的刚性连接件130柔顺性更好,例如当支架弯曲时,刚性连接杆如果平行于中轴线,则刚性连接件130将全部受力,而如果相对倾斜,则只会在弯曲形变处附近受力;另外,刚性连接件130倾斜设置可以配合在轴向上形成螺旋排布,进一步提高支架整体的弯曲顺应性。 With respect to the rigid connection member arranged parallel to the central axis 130, inclined rigid links 130 and better flexibility, when the stent is bent, for example, if the rigid connecting rod parallel to the central axis, the rigid connection member 130 will be fully force, If a relative tilt, only in the vicinity of the bending deformation force; further, the rigid connecting member 130 may be disposed obliquely arranged with a spiral formed in the axial direction, further enhance the overall stent bending compliance.

[0052] 在使用软性连接件131进行连接的位置,各波形环状物100均设有用于固定软性连接件131的连接孔(例如连接孔116和123)。 [0052] In the position of use of the flexible connecting member 131 is connected, each waveform collar 100 has fixing holes for connecting the flexible connection member 131 (e.g., connection holes 116 and 123). 连接孔的位置是在波形环状物100的近端顶点或远端顶点。 Position of the connection holes is proximal apex or vertex of the distal end ring 100 of the waveform.

[0053] 软性连接件131可以采用柔性的软线,软性连接件131为单股具有高拉伸强度的、与人体相容的丝线;或者软性连接件131为一种或多种上述丝线经多股混纺的混合线。 [0053] The flexible connection member 131 may employ a flexible cord, flexible connection member 131 having a single strand of high tensile strength, and body compatible filaments; flexible connection member 131 or one or more of the above multi-strand wire was blended hybrid wire. 上述丝线可以为高分子材料制成,例如软性连接件131的材料为具有较高拉伸强度的PE(聚乙烯,polyethylene)、PTFE (聚四氟乙烯,Polytetrafluoroethylene)、PET (聚对苯二甲酸乙二醇酯,Polythylene terephthalate)、PP(聚丙烯,Polypropylene)材料的缝线或者其他医用缝线及其组合缝线,可以是单股也可以是多股相同或不同材料混纺的混合线。 Said wire may be made of a polymer material, such as a material for the flexible connection member 131 PE (polyethylene, Polyethylene) having high tensile strength, PTFE (PTFE, Polytetrafluoroethylene), PET (polyethylene terephthalate polyethylene terephthalate, Polythylene terephthalate), PP (polypropylene, polypropylene) or other medical suture material of the suture and suture combination, may be single-stranded may be the same or different strands of material blended hybrid wire. 优选软性连接件131为多种丝线多股混纺的混合线,通过试验证明:采用混合线相对于单一材料,具有更可靠的连接和拉伸强度,更适合用于裸支架段10的连接和打结固定。 Connecting member 131 is preferably more flexible multi-strand wire blended hybrid wire through experiments proved that: with respect to a single line mixed material, having a more reliable connection and tensile strength, is more suitable for the bare stent 10 and connecting segments fixed knot. 本实施例中采用的软性连接件131由超高分子量PE与PP缝线组合而成,PE、PP缝线采用编织结构,该组合缝合相对于其他大多数的聚酯纤维和聚合物共混体横截面更平整,容易打较小的结,且打结更结实,另外具有更高的拉伸强度。 Employed in the flexible connection member 131 formed by a combination of ultra high molecular weight PE and PP sutures of the present embodiment, PE, PP woven structure using a suture, the suture relative to most other combination of polyester fibers and polymer blends the cross section is more smooth and easy to hit a small knot, and the knot stronger, further having higher tensile strength.

[0054] 裸支架段10的近端顶部设有锚刺114,锚刺114件朝向裸支架段10的远端。 [0054] The top section of the proximal bare stent 10 is provided with a barbed anchor 114, anchor 114 toward the distal end of the barbed section 10 of the bare stent. 具体是在裸支架段10近端的波形环状物100的近端顶点上设置有锚刺114,图7所示为管腔支架释放到腹主动脉I后的示意图,释放后近端波形环状物110的锚刺114位于肾动脉2以上,其锚刺114刺入主动脉血管壁内,保证管腔支架近端可靠的锚定;近端波形环状物110和远端多圈波圈120跨过肾动脉,保证肾动脉正常的血流供应;覆膜近端位于肾动脉下侧。 DETAILED is provided on the proximal end of the proximal apices 10 of the bare stent segment 100 of the waveform with an anchor annulus stab 114, FIG. 7 is a schematic view of the abdominal aorta is released into the lumen of the stent as shown in I, the waveform of the proximal end of the release ring 114 was barbed anchor 110 is positioned above the renal arteries 2, barbed anchor 114 which pierce the aortic vessel wall, the proximal lumen of the stent to ensure reliable anchoring; waveform proximal end 110 and a distal ring waves multiturn coil 120 across the renal arteries to ensure the renal artery of normal blood supply; film side of the proximal end of the renal artery.

[0055] 如图3-16所示,波形环状物100可包括近端波形环状物110和远端波形环状物120,相邻的近端波形环状物110和远端波形环状物120之间的波形相位异步;或者近端波形环状物110的波宽大于远端波形环状物120的波宽。 [0055] shown in Figure 3-16, waveform 100 may include a proximal collar 110 and distal annular wave waveform ring 120, adjacent proximal end 110 and a distal end annulus waveform cyclic waveform asynchronous waveform phase between the object 120; or proximal end 110 of the wave waveform annulus wider than the distal end 120 of the waveform of the wave ring width. 如此设置可利于刚性连接件130相对中轴线倾斜(不平行),从而使得支架整体的弯曲顺应性提高,还利于刚性连接件130在轴向上配合形成螺旋状,进一步提高支架整体的弯曲顺应性。 Thus facilitate rigid connection member can be disposed relative to the central axis 130 is inclined (non-parallel), so that the entire stent is bent to improve compliance, but also facilitate rigid connection member 130 cooperate to form a spiral in the axial direction, further enhance the overall stent bending compliance . 当然,图示实施例仅用作举例,近端波形环状物110和远端波形环状物120的波宽可相同,波形相位可同步。 Of course, the illustrated embodiment way of example only, wave waveform proximal ring 110 and distal ring 120 of the waveform may be the same width, the phase of the waveform can be synchronized.

[0056] 以下根据不同波形环状物100排布方式具体详述多个不同裸支架段10的实施方式: [0056] Depending on the collar 100 arranged waveform DETAILED DETAILED plurality of different embodiments of the bare stent segment 10:

[0057] 第一种实施方式:如图3-7所示,裸支架段10包括两个波形环状物100,分别为近端波形环状物110和远端波形环状物120,波形环状物100可以是Z形波、V形波或正弦波坐寸ο [0057] The first embodiment: as shown in Figure 3-7, the bare stent segment 10 comprises two waveforms collar 100, respectively, the proximal ring 110 and distal waveform waveforms ring 120, the wave ring Z was 100 may be wave-shaped, V-shaped or sine wave sit inch ο

[0058] 如图3-5所示,近端波形环状物110的支撑部112,首尾相接形成Z形波、近端顶点Illa和远端顶点Illb,近端顶点111a、远端顶点Illb处分别过渡形成一圆弧115a, 115b,远端顶点处设置连接孔116。 [0058] shown in Figure 3-5, the proximal end of the support ring portion 112 waveform 110, end to end to form a Z-shaped wave, and a distal end proximal apex Illa Illb vertex, vertex proximal end 111a, a distal apex Illb a transition arc are respectively formed at 115a, 115b, the distal end of the connection hole 116 is provided at the apex. 本实施例形成6个Z波形单元,如图5a所示,波形高度hi (近端顶点Illa到远端顶点Illb间的垂直距离)为9mm。 Embodiment 6 of the present embodiment is formed waveform Z units, shown in Figure 5a, the wave height hi (Illa proximal apex to apex of the vertical distance between the distal end Illb) is 9mm.

[0059] 如图3、4、5a、5b所示,近端顶点11 Ia向近端方向延伸有锚刺柱113,锚刺柱113上设置有与锚刺柱113 —体成形的锚刺114,锚刺114设置是从锚刺柱113近端周向突出,并延伸指向远端,与锚刺柱113表面成夹角Y,如图5b所示,夹角Y在20°〜60°之间,优选夹角Y为45°,锚刺114长度在2mm〜5mm之间,优选3mm。 [0059] FIG 3,4,5a, 5b, the proximal apex 11 Ia in the proximal direction extending barbed anchor column 113, the column has a barbed anchor 113 with the pillar 113 disposed barbed anchor - shaped anchor member 114 stab , barbed anchor 114 is disposed to protrude from the periphery of the proximal anchor 113 thorn column and extending distally directed, with barbed surface anchor post 113 at an angle Y, shown in Figure 5b, at an angle Y of 20 ° ~60 ° room, preferably the angle Y is 45 °, the length 114 between the barbed anchor 2mm~5mm, preferably 3mm. 使用时锚刺114可刺入血管内,刺入位置内膜可爬覆,通过这种方式可实现支架近端可靠的固定,避免支架术中和远期的移位。 When piercing barbed anchor 114 may be provided with a blood vessel, the insertion position can climb intima coating, can be achieved in this way reliable fixation stent proximal end, and to avoid the shift in long-term stenting.

[0060] 远端波形环状物120包含近端顶点121a、远端顶点121b以及在相邻近端顶点121a和远端顶点121b之间的支撑部112。 [0060] waveforms distal ring 120 includes proximal apex 121a, 121b and the distal end of the support portion in the apex between adjacent proximal apex 121a and 121b the distal end 112 of the apex. 远端波形环状物120波形个数大于近端波形环状物110波形个数,为9个波形,但围合形成的柱面周长基本相等,因此波宽减少,波形高度与近端波形环状物110相等,也为9_。 Waveform distal annulus 110 waveform 120 waveform data is greater than the number of waveform proximal ring, nine waveforms, but the circumference of the cylindrical enclosure is formed substantially equal, thus reducing the pulse width, wave height of the waveform of the proximal end equal to the ring 110, it is also 9_. 近端顶点121a处设置连接孔123。 Provided at the proximal apex 121a connecting hole 123.

[0061 ] 近端波形环状物110与远端波形环状物120是通过3条倾斜刚性连接件130和3条软性连接件131连接在一起,连接孔116、连接孔123之间固定有软性连接件131。 [0061] waveforms proximal end 110 and distal ring 120 is a wave ring connected by three oblique rigid connection 130 and three flexible connecting member 131 together, the connecting hole 116, hole 123 is connected between the fixed flexible connection member 131. 如图6所示,刚性连接件130与裸支架段10中轴线垂直的圆周线的夹角δ为20。 6, member 130 is rigidly connected to the circumferential line segment perpendicular to the axis 10 of the bare stent 20 is the angle δ. 〜45°,本实例中为30°。 ~45 °, the present example is 30 °.

[0062] 如图3、4所示,远端波形环状物120远端顶点121b处设置缝合孔124,用来将裸支架与管腔支架的覆膜201近端连接在一起。 [0062] As shown, the distal end 120 of the distal apex 121b disposed 3,4 waveform annulus suture hole 124, 201 for connecting together the proximal bare stent coated with the lumen of the stent.

[0063] 如图2所示,覆膜支架段20包括覆膜201和金属骨架202,金属骨架202为镍钛丝编织而成的正弦波形,覆膜201为PFFE(聚四氟乙烯,Polytetrafluoroethylene)或PET(聚对苯二甲酸乙二醇酯,Polythylene terephthalate)材料,经过热处理贴覆或缝合的方式连接为一体。 Shown, stent-graft covered section 20 includes a metal frame 201 and 202, the metal frame 202 braiding [0063] FIG. 2 is a nickel titanium wire made of a sinusoidal waveform, the coating film 201 is PFFE (PTFE, Polytetrafluoroethylene) or PET (polyethylene terephthalate, Polythylene terephthalate) material, a heat treatment is pasted after the manner of stitching or integrally connected.

[0064] 图7所示为管腔支架释放到腹主动脉I后的示意图,释放后近端波形环状物110位于肾动脉2上侧附近,其锚刺114刺入肾动脉2上侧的主动脉血管壁内,保证管腔支架近端可靠的锚定;近端波形环状物110和远端波形环状物120跨过肾动脉,保证肾动脉正常的血流供应;覆膜支架段20的近端位于肾动脉下侧。 [0064] FIG. 7 is released into the lumen of the stent Scheme I the abdominal aorta, the proximal collar 110 is released after the waveform is located in the upper side 2 near the renal arteries, which pierce the anchor spines 114 on the side of the renal artery 2 aortic vessel wall, the proximal lumen of the stent to ensure reliable anchoring; waveform proximal end 110 and distal ring 120 is an annular wave across the renal arteries, the renal arteries to ensure normal blood supply; stent-graft segment the proximal end 20 is located in the lower side of the renal artery.

[0065] 裸支架段10的第二种实施方式:裸支架段10采用多于两个的波形环状物100,即一个近端波形环状物110、两个或多个远端波形环状物120。 A second embodiment of the [0065] 10 of the bare stent segment: the bare stent 10 segments to use more than two waveforms ring 100, i.e., a waveform of the proximal ring 110, distal ends of two or more cyclic waveforms He was 120.

[0066] 近端波形环状物110结构同第一种实施方式,在此不再赘述。 [0066] waveforms proximal ring structure 110 with a first embodiment, not described herein again.

[0067] 相对于第一种实施方式,多个远端波形环状物120的设置增加了裸支架段10的整体长径比,会有更好的柔顺性,顺应更加复杂的瘤颈夹角,同时较长的裸支架段长度可以使得近端波形环状物110进入到肾上腹主动脉平直段,贴壁性更好,近端锚定更加稳定。 [0067] with respect to the first embodiment, a plurality of waveforms distal ring 120 increases the overall aspect ratio of the bare stent segment 10, have better flexibility, adapt to more complicated aneurysm neck angle , while a longer length may cause the bare stent proximal annulus 110 into the waveform of the straight segment suprarenal abdominal aorta and better adherence, proximal anchoring more stable. 最远端的远端波形环状物120与管腔支架近端覆膜201位置缝合在一起。 The most distal end of the distal annulus 120 waveform are sewn together with the proximal lumen of the stent 201 covered position. 其中近端波形环状物110可根据需要设置,例如可与第一种实施方式中近端波形环状物110结构相同。 Wherein the proximal end of the cyclic waveform 110 may be provided as necessary, for example, same as the first embodiment, the proximal end of the annulus 110 a waveform structure.

[0068] 图9所示为第二种实施方式的裸支架段10的平面展开示意图。 [0068] Figure 9 is a section of a second embodiment of the bare stent 10 expanded schematic plane. 多个远端波形环状物120沿轴向平行排布于近端波形环状物110的远端,波形彼此同相位且波宽相等,本实施例中设置6个远端波形环状物120,相邻远端波形环状物120轴向部分重叠,呈鱼鳞状排列,即相邻的两个波形环状物100的近端顶点或远端顶点之间的间距小于波形高度。 A plurality of waveforms distal ring 120 in the axial direction are arranged in parallel to the proximal end of the distal annulus 110 of the waveform, the waveform and the phase of the wave with each other equal to the width, provided in Example 6 ring 120 distal waveforms embodiment , axial portion 120 adjacent the distal end of the waveform overlapping ring, was scaly arrangement, the distance between the distal end proximal apex or vertex i.e. two adjacent ring 100 is smaller than the wave height of the wave. 如图10所示,重叠距离为d优选为1/3〜2/3个波形高度,本实施例中重叠距离为d为1/2个波形高度。 10, the overlap distance d is preferably 1 / 3~2 / 3 wave height, according to the present embodiment, the overlap distance d is 1/2 embodiment of wave height. 本实施例中每个远端波形环状物120由9个Z形波形组成。 In this embodiment the distal end of each ring 120 by the waveform 9 Z-component of the waveform. 每个波形高度为 Each wave height

8.0mm,前后两个远端波形环状物120之间重叠距离为4mm。 8.0mm, waveforms before and after the two distal annulus 120 between the overlap distance of 4mm. 远端波形环状物120中相邻两个远端波形环状物120之间通过3个刚性连接件130和3个柔性的软性连接件131连接在一起。 Waveform two distal annulus 120 adjacent the distal end of the waveform between annulus 120 are connected together by a rigid connection 3 and 3 130 flexible flexible connection member 131. 刚性连接件130与支架整体激光切割而成,柔性的软线采用PE+PP组合的混合线,软性连接件131连接方式通过连接孔连接。 A rigid connecting member 130 integrally with the laser cut stent is made using a flexible cord PE + PP hybrid wire combination, the flexible member 131 is connected through the connection hole connection mode.

[0069] 本实例中多个远端波形环状物120之间的刚性连接件130在轴向上呈直线形设置,即相邻远端波形环状物120之间的刚性连接件130平行于中轴线,并且轴向上相邻的刚性连接件130在同一直线上排布。 [0069] waveforms present example, a plurality of distal collar rigid connection between the rectilinear 120 130 in the axial direction, i.e. parallel to the adjacent rigid member 130 connected between the distal end of the waveform 120 in ring axis, and adjacent the axially rigid connecting member 130 are arranged on the same straight line. 如图9所示,本实例中远端波形环状物120之间的柔性软性连接件131也呈直线形设置。 9, the present example the distal end of the flexible annulus waveform flexible connection element between the rectilinear 120,131 also provided. 在周向上,刚性连接件130和软性连接件131交错排布,即两个刚性连接件130之间设有一个软性连接件131。 Up rigidly connected flexible connection members 130 and 131 are arranged staggered in the circumferential direction, i.e., member 131 is provided with a flexible connection between two rigid links 130.

[0070] 近端波形环状物110和近端的第一个远端波形环状物120的连接方式,与第一种实施方式中近端波形环状物I1和远端波形环状物120的连接方式相同。 Connection [0070] waveforms proximal ring 110 and a proximal end a distal end of the first waveform ring 120, with the first embodiment, the proximal and distal waveform waveforms I1 ring annulus 120 the same connection. 为了保证近端波形环状物110和远端波形环状物120之间的轴向连接强度,远端波形环状物120设置有刚性连接件130的近端顶点与近端波形环状物110远端顶点通过倾斜的刚性连接件130连接在一起,不改变近端波形环状物110波形的形状,且保证近端波形环状物110波形沿周向分布均匀,刚性连接件130与裸支架段10中轴线的夹角为30°。 In order to ensure the axial distance between the proximal end of the waveform 110 and the distal annulus 120 is connected to the annular intensity waveform, the waveform distal ring member 120 is provided with a rigid connection with the proximal end of the proximal apex 130 of waveform 110 ring vertices connected by the distal end of the rigid connecting member 130 is inclined together, without changing the shape of the waveform of the proximal ring 110 of the waveform, and the waveform of the proximal annulus 110 to ensure that the waveform direction circumferentially distributed evenly, rigidly connecting member 130 and the bare stent the angle between the axis section 10 is 30 °.

[0071] 如图8、9、11所示,最远端的远端波形环状物120可以跟其他的远端波形环状物120相同,也可以是波形个数相同,波形高度略高。 As shown in [0071] FIG. 8, 9, 120 may be the same with other waveforms distal annulus 120 of the distal end of the distal-most waveform ring, may be the same number of waveforms, wave height slightly. 本实施例中,最远端的远端波形环状物120波形高度为9mm,最远端的远端波形环状物120远端顶点处设置缝合孔124,用来将裸支架段10与管腔支架的覆膜20近端连接在一起。 In this embodiment, the distal end 120 of the wave height of the most distal ring 9mm waveform, the distal end 120 of the distal end of the distal-most apex of the waveform annulus suture hole 124 is provided for the bare stent 10 and the tube segment covered stent proximal lumen 20 are joined together.

[0072] 图12所示为管腔支架释放到腹主动脉I后的示意图,释放后,近端波形环状物110位于肾动脉2以上,其锚刺214刺入主动脉血管壁内,保证管腔支架近端可靠的锚定;远端波形环状物120跨过肾动脉2,保证肾动脉正常的血流供应;覆膜支架段20近端位于肾动脉下侧。 [0072] FIG 12 is released into the lumen of the stent after schematic abdominal aorta I, after the release ring 110 is positioned proximal the waveform 2 above the renal arteries, which pierce the anchor 214 within the vessel wall puncture the aorta, to ensure the proximal end of the lumen of the stent reliable anchor; waveform distal annulus 120 2 across the renal arteries, the renal arteries to ensure normal blood supply; stent graft proximal segment 20 located between the renal artery side.

[0073] 第三种实施方式:如图13、14所示,第三种实施方式是在第二种实施方式基础上的变形,将多个远端波形环状物120之间的刚性连接件130和软性连接件131的排布方式进行变化。 [0073] Third Embodiment: FIG. 13 and 14, the third embodiment is a modification on the basis of the second embodiment, the rigid connection between the distal end of the more than 120 waveforms ring 130 changes and the flexible connection member 131 arranged manner. 每个刚性连接件130和软性连接件131都平行于中轴线,刚性连接件130在裸支架段10的轴向上呈螺旋状;和/或软性连接件131在裸支架段10的轴向上呈螺旋状。 Each rigid link 130 and the flexible connection member 131 are parallel to the central axis, the rigid connecting member 130 helically in the axial direction of the bare stent segment 10; a shaft 131 of the bare stent segment 10 and / or the flexible connection member upward spiral.

[0074] 本实施方式中,相邻远端波形环状物120之间通过3个刚性连接件130和3个软性连接件131连接在一起。 [0074] In the present embodiment, the distal end of the waveform adjacent ring connected by three rigid connection member 130 and 3 131 between the flexible connection member 120 together. 本实例中远端波形环状物120之间的刚性连接件130在轴向呈螺旋形,轴向前后两个刚性连接件130不在同一直线上,在周向上间隔一个波形距离设置。 Rigid connection between the distal end 120 of the present example, the waveform ring 130 in the axial direction spirally, two longitudinal axially rigid connecting member 130 are not aligned, circumferentially spaced from one waveform set. 这样的排布方式中,当近端的裸支架段10弯曲时,相邻两个波形环状物100之间同一轴线上的弯曲阻力较第二种实施方式进一步降低,可进一步提高管腔支架的柔顺性,适应更为复杂的瘤颈形态;远端波形环状物120之间的软性连接件131也呈螺旋形。 Such arrangement described above, when the bare stent segment 10 is bent proximal end, adjacent bending resistance on the same axis than the second embodiment is further reduced between the two waveforms ring 100 can be further improved intraluminal scaffold the flexibility to adapt to a more complex form of the aneurysm neck; flexible connection member 131 between the distal end ring 120 also waveform spiral. 周向上,刚性连接件130和软性连接件131同样间隔一个波形距离。 Circumferential direction, a rigid connecting member 130 and the flexible connection member 131 spaced the same distance from a waveform.

[0075] 近端波形环状物110结构可与第一种实施方式相同,在此不再赘述。 [0075] The waveform of the proximal collar 110 may be identical to the structure of the first embodiment, it is omitted herein.

[0076] 第四种实施方式:如图15、16所示,是本实施例中近端裸支架段10包括一个近端波形环状物110、两个或多个远端波形环状物120。 [0076] Fourth Embodiment: FIG. 15 and 16, the proximal bare stent segment 10 includes a proximal end embodiment waveform ring 110, two or more waveforms distal ring 120 of the present embodiment . 其中近端波形环状物110与第一种实施方式中的近端波形环状物I1结构相同。 Wherein the proximal end of the same waveform waveform proximal ring 110 with a first embodiment of the ring structure I1.

[0077] 如图16所示,远端波形环状物120由9个波形组成,两个远端波形环状物120之间有三个周向上均匀分布且倾斜的刚性连接件130,倾斜的刚性连接件130连接第一个远端波形环状物120的远端顶点121b和相邻第二个远端波形环状物120的近端顶点121a。 [0077] As shown in FIG. 16, the distal end ring 120 of the waveform component of the waveform 9, there are three weeks rigid connection member is inclined upwardly uniformly distributed and 130, inclined rigid annulus between two distal waveforms 120 a distal end 130 connected to the first and second proximal apex 121b waveforms distal annulus 120 adjacent vertices 121a connecting member distal end 120 of the waveform ring. 周向上,两个刚性连接件130之间,通过软性连接件131连接在一起。 Circumferential direction, between two rigid connection members 130 connected together by a flexible connection member 131. 软性连接件131连接的近端顶点121a设有连接孔116,远端顶点121b设有连接孔123,用于软性连接件131的连接固定。 Proximal apex flexible connection member 131 is connected to connector 121a provided with hole 116, the distal apex 121b connecting hole 123 is provided for connecting the flexible connecting member 131 is fixed. 近端和中间的远端波形环状物120波形的高度为9_。 Height intermediate the proximal and distal ring 120 waveform waveform is 9_.

[0078] 最远端的远端波形环状物120与近端波形环状物110的波形数量相同,波形高度略大于远端波形环状物120波形高度,波形高度为10mm,最远端的远端波形环状物120远端顶点处设置缝合孔124,与用来将裸支架与覆膜支架段连接在一起。 [0078] The distal end of the distal-most end of the proximal end of the waveform 120 waveform 110 waveform ring the same number of rings, the wave height slightly greater than the wave height of the distal end ring 120 wave, a wave height of 10mm, the most distal the distal end of the distal end 120 at the apex of the waveform annulus suture hole 124 is provided, and connected to the bare stent and stent-graft segment.

[0079] 近端波形环状物110与远端波形环状物120之间的连接方式与相邻的远端波形环状物120之间的连接方式相同,均只采用3个倾斜的刚性连接件130连接,且与远端波形环状物120的刚性连接件130在圆周向构成螺旋状。 Connection between the same 120 [0079] waveforms proximal ring 110 and distal ring with the adjacent waveform distal waveform connection between annulus 120, are rigidly connected using only three inclined connecting member 130, and the waveform of the distal end ring 120 is a rigid connection member 130 in a helical configuration circumferentially.

[0080] 本实施方式中,波形环状物100包括与相邻波形环状物100无连接的至少一组悬空近端顶点125和/或至少一组悬空远端顶点126,每组悬空近端顶点125包括I个悬空近端顶点或2个相邻的悬空近端顶点,每组悬空远端顶点126包括I个悬空远端顶点或2个相邻的悬空远端顶点。 [0080] In the present embodiment, the waveform 100 includes a collar 100 without dangling at least one set of vertex 125 connected to the proximal end and / or at least the distal end of a set of vertices vacant 126, each floating ring adjacent to the proximal end of the waveform dangling vertex 125 comprises the I or 2 adjacent proximal apex vacant proximal apex, each apex of the distal end 126 includes an I dangling a floating distal apex or 2 adjacent the distal end dangling vertex. 这些悬空远端顶点126和悬空近端顶点125在裸支架段10中省去一部分刚性连接件130,使上述相邻的波形环状物100的部分远端顶点与近端顶点之间处于悬空状态,可减少整体弯曲刚度,此部分悬空远端顶点126和悬空近端顶点125因无束缚而可紧贴血管壁甚至轻微刺入血管壁,增加了管腔支架的锚定。 These dangling vertex distal end 126 and proximal apex 125 suspended portion of the rigid connecting member 130 is omitted in the bare stent segment 10, so that the waveform of the adjacent ring is floating between the apex and the distal end portion 100 of the proximal apices , can reduce the overall bending stiffness, this apex 126 and the distal end portion of floating suspended by the unbound proximal apex 125 against the vessel wall but may even pierce the vessel wall slightly increases the anchoring of the stent lumen. 与此同时,因每一组悬空远端顶点或悬空近端顶点中悬空顶点的数量不超过2个,在周向上两侧有刚性连接件和软性连接件进行约束,因此上述具有悬空顶点的波形不会大幅度翻转而深入血管壁中、对血管产生新的损伤。 At the same time, because the distal end of each set of vertices or left dangling vertex number of dangling vertex proximal no more than 2, up rigid member and the flexible connection member is connected to constrain both sides in the circumferential direction, thus having the above-described vacant vertices waveform would not significantly flip and deep in the vessel wall, creating new damage to the blood vessels. 其余结构同第一种实施方式,在此不再赘述。 With the remaining structure a first embodiment, not described herein again.

[0081] 第二-第四种实施方式都是在第一种实施方式基础上增加了远端波形环状物120的数量,远端波形环状物120位于肾动脉中及肾动脉下侧附近,对于肾上夹角较大的血管形态,远端波形环状物120除了要求避免切断流入肾动脉、肠系膜动脉的血流外,还需要具有很好的柔顺性以顺应血管,因此刚性连接件130的倾斜设置和软性连接件131都增加了管腔支架的柔顺性,同时裸支架总体长度增加,可以使得近端环状物位于肾动脉以上比较平直的动脉血管内,使其锚刺114结构能够完全扎入血管内,具有很好的贴壁性能与抗移位性能。 [0081] The second - fourth embodiment In a first embodiment is based on embodiment increases the number of waveforms distal ring 120, distal ring 120 is located in the waveform renal artery and renal artery side for larger angle on renal vascular morphology, the distal end ring 120 in addition to the waveform desired to avoid cutting the inflow renal artery, mesenteric artery blood flow, but also need to have good flexibility to conform to a blood vessel, the rigidity of the connecting element and a flexible connecting member inclined 131,130 have increased flexibility of the lumen of the stent, while increasing the overall length of the bare stent, such that the proximal ring can be positioned above the renal arteries in a relatively straight arteries, so that the anchor thorn structure 114 can be fully pierced into the blood vessel, with good performance and anti-adherent properties displaced.

[0082] 为能适应血管大小不同,位置各异的患者,依据成年人腹主动脉直径情况,本发明可以设计成不同型号规格。 [0082] The vessel can accommodate different sizes, different positions of a patient, according to the diameter of a human adult abdominal aorta, the present invention may be designed to specifications of different models. 以下各实施方式中各部分直径相等,或呈喇叭口形式,直径为20mm 至36mm,例如可以优选为20mm、22mm、24mm、26mm、28mm、30mm、33mm 和36mm,总长度为30 至60mm。 In the following embodiments the diameter of each portion is equal to, or in the form of flare, a diameter of 20mm to 36mm, for example, may preferably be 20mm, 22mm, 24mm, 26mm, 28mm, 30mm, 33mm 36mm, and total length of 30 to 60mm.

Claims (10)

1.一种管腔支架,包括裸支架段和与所述裸支架段相连的覆膜支架段,所述裸支架段包括至少两个同轴的波形环状物和刚性连接件,其特征在于,所述裸支架段还包括无弹性并可任意弯曲的软性连接件,所述至少两个波形环状物中每相邻的两个波形环状物通过所述刚性连接件和所述软性连接件连接,在周向上所述刚性连接件与所述软性连接件混合排布,所述软性连接件的长度略大于两个波形环状物之间的最短间距。 An intraluminal stent, comprising a stent graft and a bare stent segment segment and the segment connected to the bare stent, the bare stent segment comprises at least two coaxial ring waveforms and the rigid connecting member, wherein , the bare stent segment further comprises an inelastic flexible connection member and can be bent, at least two waveforms in each adjacent ring collar two waveforms by the rigid connecting member and the soft connecting member is connected, the shortest distance between the circumferential direction in the two waveforms annulus rigidly connected to the mixing member arranged in the flexible connecting member, said flexible connection member is slightly greater than the length.
2.根据权利要求1所述的管腔支架,其特征在于,每个所述波形环状物包括多个连续首尾相接形成波形的支撑部,所有的支撑部位于同一个圆柱面上、关于中轴线轴对称设置,多个支撑部首尾连接处形成多个近端顶点和多个远端顶点;相邻的两个波形环状物中的一个波形环状物的一个近端顶点与另一个波形环状物的一个远端顶点通过刚性连接件或软性连接件连接。 2. The lumen of the stent according to claim 1, wherein each of said waveform comprises a plurality of successive annular end to end to form a support portion of the waveform, all of the support portion in the same cylindrical surface, on symmetrically disposed spool axis, a plurality of proximal apex and a plurality of vertices connected end to end at a distal end of the plurality of supporting portions; and a proximal apex of another adjacent two waveforms in a waveform annulus annulus a distal apex waveform ring connected by a rigid connecting member or flexible connection member.
3.根据权利要求2所述的管腔支架,其特征在于,所述至少两个波形环状物包括近端波形环状物和远端波形环状物,相邻的近端波形环状物和远端波形环状物之间的波形相位异步;或者近端波形环状物的波宽大于远端波形环状物的波宽。 3. The intraluminal scaffold according to claim 2, wherein said at least two waveforms include a proximal collar and a distal collar waveform waveform annulus, annulus adjacent the proximal end of the waveform and waveform phase asynchronous ring between the distal end of the waveform; waveform or wave ring proximal to the distal end of the wide pulse width of the waveform of the annulus.
4.根据权利要求1所述的管腔支架,其特征在于,在周向上所述刚性连接件与所述软性连接件交错排布。 4. The lumen of the stent according to claim 1, wherein said connecting member circumferentially rigid flexible connection member to the staggered arrangement.
5.根据权利要求1所述的管腔支架,其特征在于,所述刚性连接件相对于所述裸支架段的中轴线倾斜设置、且位于在同一圆柱面上。 The luminal stent according to claim 1, wherein the rigid connecting member relative to the bare stent segment disposed inclined to the axis and located on the same cylindrical surface.
6.根据权利要求2所述的管腔支架,其特征在于,所述刚性连接件与所述裸支架段中轴线垂直的圆周线的夹角δ为20°〜45°。 6. The intraluminal scaffold according to claim 2, wherein the rigid connecting member to the bare stent segment angle δ in the circumferential line perpendicular to the axis of 20 ° ~45 °.
7.根据权利要求1所述的管腔支架,其特征在于,所述软性连接件为单股具有高拉伸强度的、与人体相容的丝线;或者所述软性连接件为一种或多种丝线经多股混纺的混合线。 7. The intraluminal scaffold according to claim 1, wherein said flexible connection member is a single strand of high tensile strength wires are compatible with the human body; said flexible connection member or as a blends or multi-strand wires through a variety of hybrid wire.
8.根据权利要求7所述的管腔支架,其特征在于,所述丝线由高分子材料制成,所述高分子材料包括PE、PTFE, PET和PP中的至少一种。 8. The lumen of the stent according to claim 7, wherein said wire is made of a polymeric material, the polymeric material comprises PE, PTFE, at least one of PET and PP.
9.根据权利要求2所述的管腔支架,其特征在于,所述波形环状物包括与相邻波形环状物无连接的至少一组悬空近端顶点和/或至少一组悬空远端顶点,每组悬空近端顶点包括I个悬空近端顶点或2个相邻的悬空近端顶点,每组悬空远端顶点包括I个悬空远端顶点或2个相邻的悬空远端顶点。 9. The intraluminal scaffold according to claim 2, wherein said waveform comprises a non-cyclic ring connected to the waveform of at least one set of adjacent vertices dangling proximal and / or distal end of at least one group of floating vertices, each proximal apex comprising floating suspended proximal apex or the I 2 adjacent vacant proximal apex, the distal end of each dangling vertex I comprises a floating distal apex or 2 adjacent the distal end dangling vertex.
10.根据权利要求1所述的管腔支架,其特征在于,所述刚性连接件在裸支架段的轴向上呈螺旋状或者直线排布;和/或所述软性连接件在裸支架段的轴向上呈螺旋状或者直线排布。 10. The luminal stent according to claim 1, wherein the rigid connecting member arranged linearly or spirally in the axial direction of the bare stent segment; and / or the flexible connection member in bare stent axial section or spirally arranged on a straight line.
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