CN104068912A - Intracranial vascular thrombus retrieval machine and thrombus retrieval device - Google Patents

Intracranial vascular thrombus retrieval machine and thrombus retrieval device Download PDF

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Publication number
CN104068912A
CN104068912A CN201310101113.6A CN201310101113A CN104068912A CN 104068912 A CN104068912 A CN 104068912A CN 201310101113 A CN201310101113 A CN 201310101113A CN 104068912 A CN104068912 A CN 104068912A
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China
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outer
stent
embolectomy
inner
thrombectomy
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CN201310101113.6A
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Chinese (zh)
Inventor
徐庆顺
谢志永
倪尊张
季杰
金巧蓉
吴颖妹
祁勇翔
罗七一
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上海微创医疗器械(集团)有限公司
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Priority to CN201310101113.6A priority Critical patent/CN104068912A/en
Publication of CN104068912A publication Critical patent/CN104068912A/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire

Abstract

The invention provides a vascular thrombus retrieval machine and a thrombus retrieval device which are particularly applicable to retrieving thrombi in intracranial blood vessels. The thrombus retrieval machine comprises an outer-layer stent and an inner-layer stent. The inner-layer stent and the outer-layer stent are netted, the outer-layer stent covers the inner-layer stent, and a gap is formed between the outer-layer stent and the inner-layer stent. The vascular thrombus retrieval machine and the thrombus retrieval device have the advantages that the thrombi can be firmly fixed by the aid of the vascular thrombus retrieval machine in withdrawal procedures after being captured, accordingly, the capturing stability can be improved, the thrombi can be prevented from falling off, the problem of secondary embolism of distal blood vessels due to the fact that plaques on the walls of blood vessels and fragmental thrombus blocks are easy to fall off can be solved, and the vascular thrombus retrieval machine and the thrombus retrieval device are small in size and good in flexibility.

Description

颅内血管取栓器及取栓装置 Intracranial thrombectomy and embolectomy device is

技术领域 FIELD

[0001] 本发明涉及医疗器械,具体涉及一种介入血管的医疗器械,特别涉及一种颅内血管取栓器。 [0001] The present invention relates to medical devices, particularly to a vascular interventional medical devices, and particularly to a vascular intracranial thrombectomy device. 本发明还涉及一种包括该取栓器的颅内血管取栓装置。 The present invention also relates to a thrombectomy apparatus of the intracranial thrombectomy device comprises.

背景技术 Background technique

[0002] 血管内血栓是临床上的常见病和多发病,而颅内血栓又是重中之重,它造成脑栓塞,具有发病率高、致残率高、死亡率高和复发率高的特点,是中老年人致死和致残的主要疾病。 [0002] intravascular thrombosis and is a common clinical disease, and cerebral thrombosis is the most important, it causes cerebral embolism, having a high incidence, high morbidity, mortality and high recurrence rate features, is the major diseases of death and disability in the elderly. 而随着老年人口的不断增加和生活水平的提高,脑血管病的发病率在不断升高。 With the improvement of living standards and the increasing elderly population, the incidence of cerebrovascular disease in rising. 根据调查,我国目前每年有300万的新增脑血栓群体,而急性脑血栓占脑卒中的比例也由55.8%上升到81.6%,成为脑部第一大疾病。 According to the survey, China currently has three million of the new group each year cerebral thrombosis, cerebral thrombosis and acute stroke accounted for the proportion rose from 55.8% to 81.6%, becoming the first major brain diseases.

[0003] 血管的再通是治疗急性缺血性脑卒中的关键。 [0003] recanalization is the key to the treatment of acute ischemic stroke. 目前颅内血栓的治疗方法主要有两种:药物溶栓和机械取栓。 The current treatment of cerebral thrombosis there are mainly two: mechanical thrombectomy and thrombolytic drugs.

[0004] 药物溶栓治疗是把溶栓剂注入病变所在的血管内的病灶附近,在病灶局部瞬间地形成很高的溶栓剂浓度,加快血栓溶解速度,进而增加血管再通的机会。 [0004] Thrombolytic therapy is the thrombolytic agent is injected into the vicinity of the lesion within the vascular disease is located, is formed in very high concentrations localized lesions thrombolytic agent instantaneously accelerate thrombolysis speed, thereby increasing the chance of recanalization. 但是,根据美国国立神经疾病与卒中研究院(NINDS)的研究结果,静脉溶栓应在发病3小时内进行,动脉溶栓时间窗为6小时之内。 However, according to findings of the US National Institute of Neurological Disorders and Stroke (the NINDS) and intravenous thrombolysis should take place within 3 hours onset, arterial thrombolysis time window is within 6 hours. 由于药物溶栓治疗时间窗较短,而且溶栓治疗只适用于体积较小的血栓,其对大体积血栓栓塞的治疗效果并不理想,所以最终大约只有3~5%的患者适合做药物溶栓治疗。 Due to the shorter time window Thrombolytic therapy, thrombolytic therapy and is only available in small volume thrombus which therapeutic effects on a large volume of thromboembolism is not ideal, in the end, only about 3 to 5% of patients with the pharmaceutical solution suitable for suppository treatment.

[0005] 机械取栓是将取栓器输送至病变位置,然后通过鞘管将血栓取出至体外。 [0005] Mechanical embolectomy embolectomy device is conveyed to the location of the lesion, and then taken out to the body through the thrombus sheath. 机械取栓包括以下几种方法:血栓切除术,这种方法取栓较为彻底,但是对血管壁损伤过大,极易引起各种并发炎症;激光碎栓,这种方法操作难度大,激光能量过低则无效,能量过高则损伤血管,而且同样易引起各种并发症;抓捕器取栓,这种方法操作简单,对血管壁损伤很小,但是经常不能套住血凝块;捕栓网取栓,这种方法操作简单,但因捕栓网体积较大而无法在颅内血管内使用。 Mechanical thrombectomy include the following methods: thrombectomy, embolectomy this method is more thorough, but too much damage to the vessel wall, which concurrency can easily cause inflammation; laser thrombectomy, big difficulty this method of operation, the laser energy invalid too low, too high energy vascular injury, and it can lead to the same complications; embolectomy capture device, this method is simple, very little damage to the vessel wall, but often can not trap blood clots; catch thrombectomy plug network, this method is simple, but the catch bolt bulky network can not be used in the intracranial vasculature.

[0006] 中国实用新型专利03210077.9公开了一种椭球形血管远端保护器,其包括设有骨架的两端尖的椭球形保护器主体和多孔的高分子膜,高分子膜覆盖在骨架上部,以允许正常血流通过而将由脱落的斑块或形成的血栓等固体颗粒滤住,从而保护下游血管不被堵塞。 [0006] Chinese utility model patent 03210077.9 discloses an ellipsoidal vessel distal protection device, comprising ellipsoidal protector body and the porous polymer film is provided with pointed ends skeleton, a polymer film overlaid on top of the skeleton, thrombosis solids filtered off to allow normal blood flow through the shed by plaque formation or live, to protect the downstream vessels are not blocked. 中国实用新型专利200620164685.4则公开了一种用于下肢动脉的取栓器,其由伞、主轴杆、推拉导丝、内外套管、外套管芯组成,伞由形状记忆合金丝制成,通过两长一短的三爪按一定角度与主轴干焊接在一起而形成,且伞周边附有网状结构,以滤住血栓。 Chinese utility model patent 200620164685.4 discloses a thrombectomy device for a lower limb, consisting of the umbrella, the main rod, the push-pull wire, the inner and outer sleeve, the outer sleeve of the core composition, the umbrella made of a shape memory alloy wire, by two a short length of the spindle and jaw angularly welded together to form a dry, outside the umbrella, and with a mesh structure, to filter thrombus live. 美国专利申请2007/0005103、2008/0243170、2011/0098738也公开了类似构造的捕栓装置,其均包括框架和附着于框架的过滤网或膜,用以滤住血栓。 U.S. Patent Application 2007 / 0005103,2008 / 0243170,2011 / 0098738 also discloses a similar construction of the catch bolt means, which comprises a frame and a filter membrane or is attached to the frame, for filtering live thrombosis. 上述取栓装置体积较大,因而无法在颅内血管内使用。 Above thrombectomy apparatus larger, and therefore can not be used in the intracranial vasculature.

[0007] 中国发明专利申请01114889.6公开了一种可用于颅内血管的可回收血栓临时滤器,其由过滤器、导向头、导引杆、连接件和外鞘组成,其中过滤器由形状记忆合金丝编织而成。 [0007] Chinese Patent Application 01114889.6 discloses a recoverable thrombosis filter temporary intracranial vessels which can be used, which by the filter, the guide head, the guide rod connecting member and the outer sheath, where the filter of shape memory alloy woven silk. 美国专利申请2011/0160763也公开了一种可用于颅内血管的取栓装置,其包括骨架,骨架可由形状记忆合金丝编织而成,以捕获血栓。 U.S. Patent Application 2011/0160763 also discloses a thrombectomy device for an intracranial vessels, comprising a skeleton, a shape memory alloy wire skeleton may be woven, in order to capture thrombi. 这些取栓装置在捕获血栓之后回收时,血栓固定不牢固、容易脱落,而且结构复杂。 These thrombectomy devices recovered after capturing the thrombus is not firmly fixed, easy to fall off, and complex structures.

[0008] 此外,利用目前的取栓装置,在取栓过程中血管壁上的斑块和破碎的血栓块很容易脱落,流向远端血管,造成新的栓塞。 [0008] Furthermore, with the current thrombectomy apparatus, vessel wall plaque and thrombi broken off easily during the embolectomy, flow distal vessel, resulting in a new plug. 据报道,约有70%的血管介入取栓手术中观察到了有血栓碎片和碎块流向远端血管,这增加了患者血管再栓塞的风险。 According to reports, thrombectomy surgery was observed in approximately 70% of endovascular thrombus debris and debris flow distal vessel, which increases the risk of thrombosis in patients with revascularization.

[0009] 因此,需要一种改进的颅内血管取栓装置,这种装置应满足以下几个条件:1)取栓过程简单、方便;2)体积小,可以方便的运送至颅内的远端血管;3)柔顺性好,捕获率高,支撑力适中,取栓过程中不会损伤血管内壁;4)在捕获血栓之后回收时,血栓固定牢固、不易脱落。 [0009] Accordingly, a need for an improved vascular intracranial thrombectomy device which should meet the following conditions: 1) thrombectomy procedure is simple and convenient; 2) small size, can be easily transported to the far intracranial end of the vessel; 3) good flexibility, the capture rate, the supporting force is moderate, the process will not damage the embolectomy vascular wall; 4) is recovered after capturing the thrombus fixation, not falling.

发明内容 SUMMARY

[0010] 有鉴于此,本发明提供了一种改进的取栓系统,该系统解决了现有技术中存在的血管壁斑块和碎血栓块容易脱落而造成远端血管再次栓塞的问题,而且体积小、柔顺性好。 [0010] Accordingly, the present invention provides an improved embolectomy system that solves the vessel wall plaques and thrombi broken prior art that may break off and cause problems embolization distal vessel again, and small size, flexibility is good.

[0011] 根据本发明的一方面,本发明提出一种血管取栓器,其包括外层支架和内层支架,内外层支架均构成为网状,且外层支架包覆在内层支架外,两者之间形成间隙。 [0011] According to an aspect of the present invention, the present invention provides a thrombectomy vessel, comprising an inner layer and an outer holder bracket, inner and outer layers are configured to mesh stent, the stent and an outer layer covering an outer inner stent , a gap is formed therebetween. 当然,取栓器也可以是多层结构。 Of course, embolectomy device may be a multilayer structure.

[0012] 优选地,所述外层支架的网孔大于内层支架的网孔。 [0012] Preferably, the outer layer is greater than the mesh stent inner mesh stent. 根据本发明的实施例,外层支架的网孔面积为3-15mm2,内层支架的网孔面积为2_10mm2。 According to an embodiment of the present invention, the outer area of ​​the stent mesh 3-15mm2, an opening area of ​​the inner stent 2_10mm2.

[0013] 以此构造,在释放后,血栓大部分通过取栓器的外层支架的较大网孔进入而小部分进入到内层支架内部,大部分血栓都留在内外支架之间的间隙中。 [0013] In this configuration, upon release, the majority of larger thrombus by embolectomy mesh stent's outer layer and into the small portion into the interior of the inner stent, most thrombosis stay in the gap between the inner and outer stent . 这样,内外支架会对留在间隙内的血栓起到挤压固定的作用,防止血栓在回撤时脱落。 Thus, the gap will remain in the inner and outer stent thrombosis fixed pressing play role in preventing blood clots off when retracement.

[0014] 根据本发明,外层支架与内层支架在近端相连接或在近端和远端均相连接。 [0014] According to the present invention, the outer holder and inner bracket or homogeneous connecting the proximal and distal connector at the proximal end. 根据本发明,外层支架与内层支架可通过焊接相连接,或利用金属套管或金属丝缠绕而相连接。 According to the present invention, the outer holder and the inner holder can be connected by welding, or with a metal or metal cannula connected to the wire winding. 金属套管和金属丝材质可以是钼、金、钨、钼钨、钼铱等,可以兼作为显影标记。 Metal sleeve and the wire may be made of molybdenum, gold, tungsten, molybdenum, tungsten, molybdenum, iridium, and can be used as a developing marker.

[0015] 优选地,内外层支架的近端和/或远端构成为椭圆形开口或圆形开口,或构成为封闭的。 [0015] Preferably, the inner and outer stent proximal and / or distal opening configured elliptical or circular openings, or as a closed. 更优选地,取栓器在其近端处的开口呈椭圆形。 More preferably, the embolectomy device oval opening at its proximal end. 这样在推拉取栓器时可以保证有效捕获面积。 So that when the push-pull plug may be taken to ensure the effective capture area.

[0016] 优选地,外层支架和/或内层支架的沿取栓器纵向相邻的网孔的中心之间的间距可以相同或者从支架的近端到远端逐渐减小,使得网孔以远密近疏的方式分布。 The distance between the centers of longitudinally adjacent [0016] Preferably, the outer layer of the stent and / or stent along the inner mesh thrombectomy device may be the same or decreases gradually from the proximal end to the distal end of the stent, such that the mesh beyond the way of close sparse distribution. 根据本发明的实施例,间距为3-15mm。 According to an embodiment of the present invention, a pitch of 3-15mm.

[0017] 根据本发明,内外层支架通过激光切割金属管材获得,其中金属管材可以是镍钛合金、钴镍合金、不锈钢等。 [0017] According to the present invention, the inner and outer stent obtained by laser cutting a metal pipe, which metal pipe may be a nickel-titanium alloy, cobalt-nickel alloy, stainless steel and the like. 或者,取栓器通过激光切割具有形状记忆效应的金属或者具有高弹性的高分子片材,然后卷曲,热处理定型而形成。 Alternatively, the thrombectomy by laser cutting a metal having a shape memory effect or a highly elastic polymer sheet, and then crimped, heat treatment finish is formed. 这样使取栓器的柔顺性和贴壁性良好。 This allows flexibility and an embolectomy good adherence.

[0018] 根据本发明,取栓器整体上呈近似圆柱形,外层支架长度为30~60mm,直径为2~6mm,壁厚为0.04~0.1Omm,内层支架长度为20~50mm,直径为2~5mm,壁厚为0.04~ [0018] According to the present invention, showing an overall embolectomy approximately cylindrical outer stent length of 30 ~ 60mm, a diameter of 2 ~ 6mm, wall thickness of 0.04 ~ 0.1Omm, inner stent length of 20 ~ 50mm, diameter is 2 ~ 5mm, the wall thickness of from 0.04 to

0.08mm。 0.08mm.

[0019] 根据本发明另一方面,本发明提出一种颅内血管取栓装置,该取栓装置包括取栓器、导引导丝或导引头、推拉导丝和外鞘管。 [0019] According to another aspect of the present invention, the present invention provides a means intracranial thrombectomy, embolectomy device which comprises a thrombectomy, a guide wire or a guide head, the guide wire and the outer sliding sheath. 导引头或导引导丝与外鞘管相连,取栓器则与推拉导丝相连,安装好的推拉导丝和取栓器被压握入外鞘管内。 Seeker guidewire or tube connected to the outer sheath, embolectomy device is connected to the push-pull wire, push wire and mounted embolectomy is crimped into the outer sheath. 取栓器可通过推拉导丝推拉而在收回位置和展开位置之间转换,在收回位置,取栓器被回收到外鞘管内,在展开位置,取栓器被推出外鞘管。 Thrombectomy may push or pull the guide wire in sliding transition between retracted position and a deployed position, in the retracted position, embolectomy is recovered into the outer sheath, in the deployed position, is introduced embolectomy outer sheath. 本发明的取栓装置的特征在于:其包括上述的取栓器。 Wherein thrombectomy apparatus of the present invention: which includes the above thrombectomy device. 根据本发明的取栓装置,可以牢固固定血栓,提高捕获稳定性,防止血栓脱落。 Thrombectomy apparatus according to the invention may be fixedly secured thrombosis, improve the stability of the capture, to prevent blood clots off.

[0020] 优选地,推拉导丝与取栓器的牵引连接点布置成在展开位置贴近血管壁。 [0020] Preferably the tow point connection, and sliding the guide wire embolectomy is disposed proximate to the vessel wall in the deployed position. 这样可提闻大体积血检的有效捕获率。 This provides an audible efficiently capture a large volume of blood tests.

[0021] 优选地,取栓器在展开位置整体呈近似圆柱形。 [0021] Preferably, in the deployed position embolectomy approximately cylindrical overall shape. 这样使取栓器具有良好的径向支撑力,从外鞘管中释放到血管后具有较好的血管贴壁性。 This allows the embolectomy has good radial strength, is released from the outer sheath into the vascular vessel having good adherent.

[0022] 使用时,将取栓器定位在颅内血管的血栓中间,回撤外鞘管,使取栓器在血栓中间位置打开。 [0022] In use, the thrombectomy positioned in the middle of intracranial vascular thrombosis, retracement outer sheath, so embolectomy open position in the middle of the thrombus. 然后,将近端血管封堵,最后将取栓器和外鞘管回撤至体外。 Then, the proximal end of the vascular occlusion, and finally embolectomy retracement to the outer sheath body.

[0023] 根据本发明的血管取栓器及取栓装置,可以有效捕获斑块和血栓碎片,增加了血栓捕获稳定性,防止了血栓脱落,从而降低再栓塞的风险。 [0023] Vascular embolectomy and thrombectomy device apparatus according to the present invention can effectively capture of plaque and thrombus debris, thrombus capturing increase stability, prevent blood clots off, thereby reducing the risk of reocclusion. 本发明的血管取栓器及取栓装置特别适合于颅内血管取栓,当然,也可以用于其它血管取栓。 Vascular present invention embolectomy and thrombectomy device is particularly adapted for the intracranial thrombectomy vessel, of course, may also be used for other vascular embolectomy. 另外,本发明的血管取栓装置结构简单,取栓过程方便容易。 Furthermore, the vascular structures thrombectomy apparatus according to the present invention is simple, convenient easy thrombectomy procedure.

附图说明 BRIEF DESCRIPTION

[0024] 通过下面参照附图对本发明实施例进行的详细描述,本发明的特征及其优点将是显而易见的。 [0024] The following detailed description of embodiments of the present invention for the drawings, features and advantages of the invention will be apparent. 在图中: In the picture:

[0025] 图1是本发明实施例的取栓装置的总体示意图。 [0025] FIG. 1 is an overall schematic view of the thrombectomy apparatus of the embodiment of the present invention.

[0026] 图2-7是本发明实施例的取栓器的示意图。 [0026] FIG. 2-7 is a schematic view of an embodiment of the thrombectomy embodiment of the present invention.

[0027] 图8显示了本发明的取栓器的内外层支架的网孔布置结构。 [0027] Figure 8 shows the arrangement of the inner and outer mesh stent thrombectomy device of the present invention.

具体实施方式 Detailed ways

[0028] 下面参照图1-8详细描述本发明的实施例。 [0028] Referring to Figures 1-8 embodiment of the present invention will be described in detail.

[0029] 为了便于描述,以下描述使用了术语“近端”和“远端”,其中“近端”指的是离操作端近的一端,远端指的是远离操作端的一端。 [0029] For ease of description, the following description the terms "proximal" and "distal", wherein "proximal" refers to the end away from the near end of the operation, the distal end refers to the end away from the operating side.

[0030] 图1显示了取栓装置I的总体示意图,其包括外鞘管2、推拉导丝3和取栓器10。 [0030] FIG. 1 shows a general schematic view of the thrombectomy device I, which comprises an outer sheath 2, 3 and push the guide wire embolectomy 10. 取栓器10与推拉导丝3相连,安装好的推拉导丝3和取栓器10被压握入外鞘管2内。 Thrombectomy device 10 is connected to the push-pull wire 3, 3 mounted sliding guidewire and embolectomy 10 is crimped into the outer sheath 2. 取栓器10可通过推拉导丝3的推拉而在收回位置和展开位置之间转换,在收回位置,取栓器10收回到外鞘管2内,在展开位置,取栓器10被推出到外鞘管2外。 Thrombectomy device 10 by push-pull and push the guide wire 3 is in transition between retracted position and a deployed position, in the retracted position, embolectomy outer sheath 10 is retracted inside the tube 2, in the deployed position, the bolt 10 is taken out to the 2 an outer sheath tube. 另外,取栓装置I还包括导引导丝(未示出),导引导丝穿过外鞘管2,用以在血管内引导取栓装置I。 Further, thrombectomy apparatus I further includes a guide wire (not shown), guide wire 2 through the outer sheath to guide the embolectomy device within the vessel I.

[0031] 此外,如图1所示,取栓器10上还设有显影标记6,以帮助定位取栓器10。 [0031] Further, as shown in FIG. 1, taken on the plug 10 also is provided with 6 opaque markers to aid positioning pin 10 is taken. 可以理解的是,外鞘管上也可以设有显影标记(未示出)。 It will be appreciated that the outer sheath may be provided with opaque markers (not shown).

[0032] 如图2-7所示,取栓器10为支架套支架结构,整体呈近似圆柱形,其包括两部分,即内层支架20和外层支架30,其中内外层支架均构成为网状,外层支架30包覆在内层支架20外,且两者之间留有间隙。 [0032] Figure 2-7, the stent 10 embolectomy sleeve support structure, an approximately cylindrical overall shape, which comprises two parts, namely, the inner holder 20 and outer holder 30, wherein the inner and outer layers are configured as a bracket mesh, the outer holder the inner holder 30 in the outer cladding 20, leaving a gap therebetween. 另外,外层支架30的网孔大于内层支架20的网孔。 Further, the outer holder 30 is larger than the inner mesh 20 of the mesh stent. 在本例中,外层支架的网孔面积为3~15mm2,内层支架的网孔面积为2~10mm2。 In the present embodiment, the outer area of ​​the stent mesh 3 ~ 15mm2, an opening area of ​​the inner bracket 2 ~ 10mm2.

[0033] 图2-7显示了本发明的取栓器的不同实施例。 [0033] Figures 2-7 show different embodiments of the thrombectomy device of the present invention. 为了简便起见,图中未显示显影标记6。 For simplicity, not shown in FIG. 6 opaque marker. 如图3、4、6和7所示,内外层支架可以只在近端连接。 As shown in FIG. 4, 6 and 7, the inner and outer layers may be connected only at the proximal end of the stent. 或者,如图2和5所示,内外层支架可以在近端和远端都连接。 Alternatively, as shown in Figures 2 and 5, the inner and outer stent may be connected at the proximal and distal ends. 连接可以是焊接连接、利用金属套管连接或利用金属丝缠绕连接等。 May be connected to a welded connection, a metal bushing connection using a wire wrap connection or the like. 另外,内外层支架的沿纵向相邻的网孔的中心之间的间距可以是相同的,也可以是从支架的近端到远端逐渐减小,如图8所示,使网孔呈远密近疏式分布,即L1>L2>L3。 Further, the spacing between the inner and outer stent along a central longitudinally adjacent mesh may be the same or may be gradually reduced from the proximal end to the distal end of the stent, shown in Figure 8, so far as a mesh of close formula sparse distribution, i.e., L1> L2> L3. 在本例中,间距范围为3~15mm。 In the present embodiment, the pitch in the range of 3 ~ 15mm.

[0034] 另一方面,如图2-4所示,内外层支架的近端可以都是封闭的。 [0034] On the other hand, as shown in Figure 2-4, the proximal end of the inner and outer layer are closed stent can. 或者,如图5-7所示,内外层支架的近端都开口。 Alternatively, shown in Figures 5-7, the proximal end of the inner and outer stent are open. 或者,内外层支架在近端和远端都是封闭的,如图2和5所示,或为一封闭一开口设计,如图3、4、6和7。 Alternatively, the inner and outer stent proximal and distal ends are closed, as shown in FIG. 2 and 5, or an opening of a closed design, 4, 6 and 7 as shown in FIG. 此外,如图2-7所示,内外层支架的近端和远端可以是椭圆形扩口、封闭收缩口或圆形开口。 Further, as shown in Figure 2-7, the proximal and distal inner and outer stent may be flared elliptical, circular opening or closing the constriction.

[0035] 取栓器10通过激光切割具有形状记忆效应的金属管材(如镍铁合金等)而形成并经热处理定型。 [0035] The bolt 10 is formed to take the heat treated shaped and cut metal pipes (such as nickel-iron alloy) having a shape memory effect by the laser. 当然,取栓器10也可以通过切割具有形状记忆效应的金属片材,然后卷曲,热处理定型而形成。 Of course, taking the bolt 10 may have a shape memory effect of sheet metal by cutting, and then crimped, heat treatment finish is formed. 取栓器10的合适尺寸如下:外层支架长度为30~60mm,直径为2~6mm,壁厚为0.04~0.1Omm,内层支架长度为20~50mm,直径为2~5mm,壁厚为0.04~ Suitable dimensions embolectomy 10 are as follows: length of the outer holder 30 ~ 60mm, a diameter of 2 ~ 6mm, wall thickness of 0.04 ~ 0.1Omm, inner stent length of 20 ~ 50mm, a diameter of 2 ~ 5mm, a wall thickness 0.04 ~

0.08mm。 0.08mm. 也可以用高弹性的高分子材料来代替金属材料。 High polymer materials may also be used instead of elastic metal material. 上述合适的材料是本领域技术人员所熟知的,在此不再详细描述。 Suitable materials are above those of skill in the art, which is not described in detail.

[0036] 推拉导丝3与取栓器10的牵引连接点布置为在展开位置贴近血管壁。 [0036] 3 and push the guide wire embolectomy of traction connection point 10 is disposed proximate the vessel wall in the deployed position. 这样可提闻大体积血检的有效捕获率。 This provides an audible efficiently capture a large volume of blood tests.

[0037] 本发明的取栓装置I的使用方法如下。 Thrombectomy apparatus [0037] I of the present invention used as follows.

[0038] 介入治疗时,首先通过血管造影确定颅内血管病变位置,然后从股动脉或肱动脉将取栓装置I导入血管内,使导引导丝穿过病变位置,通过导引导丝将外鞘管2穿过病变位置并通过外鞘管2上的显影标记(未示出)定位,期间取栓器10 —直位于外鞘管2内,处于收回位置。 [0038] When the intervention is first determined by angiography intracranial vascular lesion position, and then from the femoral or brachial artery thrombectomy apparatus I is introduced into a blood vessel, the guide wire through the guide position of the lesion, the guidewire through the sheath 2 passes through the tube and the position of the lesion through the outer sheath opaque markers (not shown) is positioned on the 2, during thrombectomy device 10 - a straight tube 2 is located in the sheath, in the retracted position. 然后,回撤导引导丝,通过推拉导丝3将取栓器10推到外鞘管2远端,回撤外鞘管2至病变位置,以将取栓器10释放,通过取栓器10上的显影标记6可定位取栓器10。 Then, retracement guide wire, the guide wire pushed by the push-pull 3 embolectomy 10 to the distal end of the outer sheath 2, 2 to the position of the lesion retracement outer sheath, to release the thrombectomy devices 10, 10 through the thrombectomy 6 opaque markers may be positioned on the bolt 10 is taken. 由于形状记忆金属的形状记忆效应或高弹性高分子材料的弹性作用,取栓器10在血液温度的作用下转换到展开位置,贴靠血管壁。 Due to the elastic action of the shape memory effect of shape memory metal or a highly elastic polymer material, thrombectomy converter 10 under the effect of the blood temperature to the deployed position, against the vessel wall. 然后,固定外鞘管2的位置,拉动推拉导丝3,回撤取栓器10捕获血栓,直至将取栓器10收回到外鞘管2内。 Then, the fixed position of the outer sheath 2, the sliding guide wire 3 is pulled, 10 thrombectomy retracement trapping emboli, until embolectomy 10 retracted inside the outer sheath 2. 最后,将取栓装置I整体撤出人体外,完成取栓过程。 Finally, the entire embolectomy device I withdrawn outside the body, to complete the thrombectomy procedure.

[0039] 采用目前的取栓系统取栓时,血管壁上的斑块和破碎的的血栓块很容易因外力作用破碎脱落,流向远端血管而造成新的栓塞,增加患者的手术风险。 [0039] When using the present thrombectomy thrombectomy system, the vessel wall plaque and thrombus blocks broken easily broken off by an external force, caused by the flow of new blood vessels distal embolization, increasing surgical risk to the patient. 本发明的设计可以牢固抓牢捕获的血栓,有效防止取栓装置在回收过程中血栓的脱落。 Design of the present invention may be firmly gripped thrombus capturing effectively prevents thrombus thrombectomy apparatus off in the recovery process.

[0040] 以上描述针对的是颅内血管取栓。 [0040] The above description is directed to intracranial thrombectomy. 可以理解的是,本发明的取栓器及取栓装置在合适的尺寸下也可以适合于其它血管内取栓。 It will be appreciated that the thrombectomy device and thrombectomy apparatus of the present invention under suitable size may be adapted to other intravascular thrombectomy. 本领域技术人员可以理解,以上描述只是示例性的。 Those skilled in the art will appreciate, the foregoing description is only exemplary. 在不背离本发明的思想和范围的情况下,本领域技术人员仍可以对本发明作出多种修改和变化。 Without departing from the spirit and scope of the present invention, those skilled in the art can still make various modifications and variations of the present invention.

Claims (12)

1.一种取栓器,其特征在于,其包括外层支架和内层支架,内外层支架均构成为网状,且外层支架包覆在内层支架外,两者之间形成间隙。 A thrombectomy device, characterized in that it comprises an inner layer and an outer holder bracket, inner and outer layers are configured to mesh stent, the stent and an outer layer covering an outer inner stent, a gap is formed therebetween.
2.根据权利要求1所述的取栓器,其中所述外层支架的网孔大于内层支架的网孔。 Embolectomy according to claim 1, claim, wherein said outer stent is a mesh larger than the inner mesh stent.
3.根据权利要求2所述的取栓器,其中外层支架的网孔面积为3-15_2,内层支架的网孔面积为2-10mm2。 Embolectomy according to claim claim 2, wherein the outer layer mesh stent 3-15_2 area, the inner opening area of ​​the stent 2-10mm2.
4.根据权利要求1-3中任一项所述的取栓器,其中外层支架与内层支架在近端相连接或在近端和远端均相连接。 According to claim 1-3 thrombectomy device as claimed in any one of the inner and outer stent scaffold or homogeneous connected to the proximal and distal connector at the proximal end.
5.根据权利要求4所述的取栓器,其中外层支架与内层支架通过焊接相连接,或利用金属套管或金属丝缠绕而相连接。 Embolectomy according to claim 4, wherein the inner and outer stent holder is connected by welding, or with a metal or metal cannula connected to the wire winding.
6.根据权利要求1-3中任一项所述的取栓器,其中内外层支架的近端和/或远端构成为椭圆形开口或圆形开口,或构成为封闭的。 According to claim 1-3 thrombectomy device as claimed in any one of the inner and outer layers wherein the proximal end of the stent and / or the distal opening configured elliptical or circular openings, or as a closed.
7.根据权利要求1-3中任一项所述的取栓器,其中外层支架和/或内层支架的沿取栓器纵向相邻的网孔的中心之间的间距相同或者从支架的近端到远端逐渐减小,使得网孔以远密近疏的方式分布。 According to claim 1-3 thrombectomy device as claimed in any one of the same pitch between longitudinally adjacent outer center support and / or along the inner stent thrombectomy device or from the stent mesh the proximal end to the distal end decreases, so that the mesh of close beyond sparse distributed.
8.根据权利要求7所述的取栓器,其中所述间距为3-15mm。 According to claim embolectomy claim 7, wherein the pitch of 3-15mm.
9.一种取栓装置,其包括导引导丝、推拉导丝和外鞘管,导引导丝穿过外鞘管,用以在血管内引导,其特征在于,该取栓装置还包括权利要求1-8中任一项的取栓器,该取栓器与推拉导丝相连,安装好的推拉导丝和取栓器被压握入外鞘管内,且所述取栓器能够通过推拉导丝推拉而在收回位置和展开位置之间转换,在收回位置,取栓器被回收到外鞘管内,在展开位置,取栓器被推出外鞘管。 An embolectomy apparatus comprising a guide wire, the guide wire and the outer sliding sheath, guidewire through the outer sheath to guide within the vessel, wherein the apparatus further comprises embolectomy claim thrombectomy device as claimed in any one of the thrombectomy wire is connected to the sliding guide, and a guide wire mounted sliding embolectomy is crimped into the outer sheath, and the bolt is taken through sliding guide push-pull wire transitions between the retracted position and a deployed position, in the retracted position, embolectomy is recovered into the outer sheath, in the deployed position, is introduced embolectomy outer sheath.
10.根据权利要求9所述的取栓装置,其中推拉导丝与取栓器的牵引连接点布置成在展开位置贴近血管壁。 10. A thrombectomy apparatus according to claim 9, wherein the tow point of attachment and push the guide wire embolectomy device is arranged close to the vessel wall in the deployed position.
11.根据权利要求9或10所述的取栓装置,其中取栓器在展开位置整体呈近似圆柱形。 11. A thrombectomy apparatus of claim 9 or claim 10, wherein in the deployed position embolectomy approximately cylindrical overall shape.
12.权利要求9-11中任一项所述的取栓装置在颅内血管取栓中的应用。 Thrombectomy apparatus according to any one of Application 9-11 intracranial thrombectomy in claim 12.
CN201310101113.6A 2013-03-26 2013-03-26 Intracranial vascular thrombus retrieval machine and thrombus retrieval device CN104068912A (en)

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