CN1244376A - 可由导管输送的螺旋线血栓形成装置和血栓形成方法 - Google Patents

可由导管输送的螺旋线血栓形成装置和血栓形成方法 Download PDF

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CN1244376A
CN1244376A CN98105499A CN98105499A CN1244376A CN 1244376 A CN1244376 A CN 1244376A CN 98105499 A CN98105499 A CN 98105499A CN 98105499 A CN98105499 A CN 98105499A CN 1244376 A CN1244376 A CN 1244376A
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conduit
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斯迪芬·C·贾考波森
克拉克·C·戴维斯
约翰·A·里泊特
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Sarcos LC
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    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01Filters implantable into blood vessels
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0006Rounded shapes, e.g. with rounded corners circular
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0091Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

一种可由导管输送的血栓形成装置,包括一个穿入体内脉管系统通道到达目标位置的导管,和一个弹性金属丝元件,该元件螺旋缠绕并具一定形状,以便在未受约束时占据一定空间,而当沿导管长度方向插入并受导管约束时变平直,从而最终从导管中释放出来并膨胀及占据目标位置。该金属丝元件包括一个第一长度金属丝和一个绕第一金属丝螺旋缠绕以形成一复合对的第二长度金属丝。该复合对本身螺旋缠绕并具一定形状,以便在未受约束时占据一定空间,而当沿导管长度方向插入并受导管约束时变平直。

Description

可由导管输送的螺旋线血栓形成 装置和血栓形成方法
本发明涉及用于体内脉管系统或体腔中阻止血流的血管闭塞装置。
截断血流和/或促使血凝并且可以通过导管或其它插管引入体内的装置,对于止血或阻止出血先兆、切断向患病器官的供血、将血流引向某个器官和修复有缺陷的器官等等是很有价值的。通常采用的装置是可通过导管配置到需阻止血流的目标位置的螺旋线或颗粒。此外,可以通过导管传送多种溶液,或者有助于并加快凝血,或者处理这类医学问题。
过去通常采用的装置包括铂质螺旋线,它们可以被插入导管中并且随后利用一个普通的导管导引线或其它装置作为“柱塞”,通过导管被推到目标位置。螺旋线装置呈所需要的形状,一般为简单的螺旋形,以便在将它们送到所需位置之后,可恢复其原有形状。已有技术的铂质螺旋线装置,在将其位置保持在被运送部位经常不起作用,因而在此部位上对阻塞血流无效。过去采用的用来阻止血流的颗粒的种类,包括PVA或亲水性颗粒,当血液被吸收时,这些颗粒会膨胀变大。当然,这种膨胀有助于阻止血流,假设颗粒的位置不变。
已有技术中阻止血流的手段相当不成熟,并且在完成所需阻止血流的过程中仅仅是部分成功的。
本发明的一个目的在于提供新的和改进的血管闭塞型装置,它们可被很容易地配置在躯体中的目标位置,并且在产生凝血或阻止血流方面有效。
本发明还有一个目的在于提供这样的装置,它们制作起来容易,并且可以在尺寸和形状上被修整制作,以适应预定的配置位置。
本发明的再一个目的就是提供这样的装置,它们可以被很快而且不费力地配置在目标位置,并保持就位。
本发明的上述以及其它目的,可以在一个血栓形成装置的具体说明的实施例中被认识到,该装置包括一个穿入人体脉管系统通道到达目标位置的导管以及一个金属丝元件,该金属丝元件被绕成螺旋形并具有一定形状,当其不受约束时占据一定体积,且当沿长度方向被插入并受导管约束时拉直,以便最终从导管中释放出来以膨胀并占据目标位置。
根据本发明的一个方面,该金属丝元件被加工成朝向其远端具有逐渐变小的直径的螺旋线。根据本发明的另一个方面,靠近其远端以及远端处的较小直径的螺旋线要紧密盘绕,以便在插入血管中时能阻止血液流过它。
金属丝元件最好是一对金属丝,一个绕另一个盘绕,随后由该复合对构成更大的螺旋线。
本发明的上述以及其它目的、特征和优点,将由下面结合附图所考虑的详细描述中变得显而易见,附图中:
图1A为根据本发明原理制做的可形成血栓的螺旋线装置的部分侧剖面图;
图1B为图1A中螺旋线沿1B-1B线所取的前端视图;
图2为根据本发明原理制做的螺旋线装置的部分侧剖面图,该装置被表示成部分地配置于导管中;
图3A为根据本发明原理的金属丝复合对的一段的部分侧视图,它可构成图3B所示的螺旋线装置;
图3B为图3A所示的金属丝复合对形成的本发明的螺旋线装置的部分侧视图,以及
图4为根据本发明的螺旋线装置另一个实施例的一部分的部分侧视图。
参见图1A和1B,它们分别表示的是已被加工成螺旋线的弹性金属丝4的部分侧剖视图和端部视图。在图1A中,所表示的金属丝4被配置在血管8中。该金属丝4包括一个较大直径的部分4a和一个逐渐变窄的部分4b。在较大直径部分4a处的螺旋线膨胀接触到血管8的壁,以将螺旋线4保持就位。较窄直径部分4b用作螺旋线4的引导端或远端,便于该装置在血管中定向,并且最好更有弹性,以将插入螺旋线时对血管壁的损伤或损坏减至最小(很快就要讨论)。
例如,金属丝4可由高弹性的镍钛合金丝制成。较大螺旋线直径部分4a的直径最好为约3mm至12mm,而部分4b中的最小直径螺旋线的直径最好约为0.75mm至2mm,上述两个范围都是在螺旋线4未受约束的情况下计算得到的。
如在部分4b中使螺旋线4的直径逐渐变小,对于血流来说可提供一个更大的障碍和密集度,并因此提供了更大的阻止血流的能力,如在沿图1A中1B-1B线所取视图1B中可以清楚地看到的那样。(通过改变金属丝弹性来控制螺旋线的锥度和间隔的做法,能够将螺旋线用作一个有限泄漏阀或者一个完全闭塞物。)
图2表示被部分设置在导管12中的螺旋线4的部分侧剖面图。为了将螺旋线4配置在脉管系统通道或体内其它腔体的目标位置处,金属丝4可以大体上平直地穿过导管12,如图2所示,并随后由另一种导线(未示出)或类似装置将其推过导管,这类装置起到了柱塞的作用以迫使螺旋线弹出到导管远端以外,随后膨胀并将其在目标位置就位。当被配置在血流经过的体内目标位置处时,螺旋线4的作用是使血流减慢以产生凝血或血凝块,并且最终阻止血液进一步流动。为了有助于凝血过程,可以在设置螺旋线4的同时通过导管12以溶液的形式向目标位置输送凝血剂。此外,连在螺旋线上的纤维材料也有助于促进凝血。
图2所示螺旋线4的实施例包括一个较窄的远端部分4b,其中的螺旋线紧密缠绕至彼此相接触的程度。由于螺旋线这种高密度堆积,血流甚至在凝血或血凝块发生之前就基本上被阻止住了。
图3A和3B表示本发明的另一实施例,其包括一个中心的金属丝20和一个绕中心丝缠绕(一级螺旋线)的外围金属丝24。该金属丝的复合对随后形成了图3B所示的一个较大的螺旋线(二级螺旋线),其中包括一个大体为圆柱形部分4a和一个圆锥形部分4b,类似于图1A所示的情况。为了在该复合对的远端部分或圆锥形部分4b获得更大的弹性,中心的金属丝20本身可以逐渐变细(或直径逐渐变小)至部分4b的一个较窄的直径,或者可以朝向其端部但未到达端部逐渐变细。当然,较窄的直径允许更大的弹性,并且可以通过控制中心丝20的直径来调整弹性度。
使中心丝20逐渐变细的一种替换方式是提供一种带有适当间隔和大小的切口的中心丝(既可以是实心的也可以是空心的),以获得所需要的弹性。
比较有利地是,螺旋线24的直径约为0.001英寸至0.005英寸。中心丝可由镍-钛合金、不锈钢或其它适合的合金或替代物制成。
图4表示本发明的血栓形成装置的另一实施例的部分侧视图。该实施例包括一个紧密缠绕的金属丝28(一级螺旋线),其螺旋线自身又形成一个更大的螺旋线圈(二级螺旋线),类似于图3B的情况,但是没有中心丝。为获得较大螺旋线的可变弹性,金属丝28的直径可以变化以致于较小直径的金属丝部分比较大直径的金属丝部分具有更大的弹性。在图4中,金属丝28的直径朝向其远端28a逐渐变小。在图4所示紧密缠绕螺旋线28形成如图3B所示较大螺旋线时,具有较窄直径的螺旋线28的那部分要位于远端或图3B的部分4b处。
当然,图4的螺旋线28可以配备类似于图3A实施例中的中心丝,该中心丝可以随着金属丝28逐渐变细而适当地变细,以便沿着两者结合的长度调整弹性度。
应当理解的是,上述结构只是对本发明原理的应用的示意性说明。对于本领域普通技术人员来说,在不脱离本发明的精神实质与范畴的前提下可以做出多种改进和替换结构,而所附权利要求书试图覆盖住这些改进和结构。

Claims (15)

1.血栓形成装置,包括:
一个穿入体内脉管系统通道到达目标位置的导管,以及
一个弹性金属丝装置,被绕成螺旋形并具有一定形状,在其未受约束时占据一定空间,而当沿导管长度方向插入并受导管约束时变平直,以便最终从导管中释放出来而膨胀并占据目标位置,所述金属丝装置进一步包括:
一个第一长度的金属丝;和
一个第二长度金属丝,它绕第一金属丝螺旋缠绕以形成一复合对,所述复合对自身被螺旋缠绕并具一定形状,以便在未受约束时占据上述空间,且当沿导管长度方向插入并受导管约束时变平直。
2.如权利要求1所述的装置,其中所述第一金属丝逐渐变细以在其一远端变得更窄,并因此在该远端更具有弹性。
3.如权利要求1或2所述的装置,其中所述第二金属丝逐渐变细以在其一远端处变得更窄,并因此在该远端处更具有弹性。
4.如权利要求1所述的装置,其中所述第一金属丝朝向不到第二螺旋线一远端的位置延伸,以使复合对的一远端比复合对的其它部分更具有弹性。
5.如权利要求1所述的装置,其中所述第一金属丝包括在沿至少一部分长度方向上所选择的位置上的多个切口,以增加其弹性。
6.如权利要求1所述的装置,其中所述复合对被加工成具有朝向远端逐渐变小直径的螺旋线。
7.如权利要求6所述的装置,其中靠近和位于远端处的较小直径的螺旋线被紧密缠绕,以便在插入血管中时能阻止血液流过它。
8.血栓形成装置,包括:
一个穿入体内脉管系统通道到达目标位置的导管,以及
一个弹性金属丝装置,被绕成螺旋形并具有一定形状,在其未受约束时占据一定空间,而当沿导管长度方向插入并受导管约束时变平直,以便最终从导管中释放出来而膨胀并占据目标位置,所述金属丝装置包括一段紧密缠绕长度的金属丝,其螺旋线自身又形成一个更大的螺旋线并具有一定形状,以便在未受约束时占据上述空间,且当沿长度方向插入导管并受导管约束时变平直,该金属丝直径朝向其远端逐渐变小,因此更具弹性。
9.如权利要求8所述的装置,其中较大螺旋线直径朝向一远端逐渐变小。
10.如权利要求8所述的装置,其中所述金属丝装置是由从包括镍-钛合金和不锈钢的一组材料中选择出来的一种材料制成的。
11.如权利要求8所述的装置,其中所述金属丝装置为实心的。
12.如权利要求8所述的装置,其中所述金属丝装置为空心的,具有围绕其中心空腔的侧壁。
13.如权利要求8所述的装置,其中还包括一个被设置用来在由金属丝装置形成的螺旋线中心延伸的芯线。
14.如权利要求13所述的装置,其中芯线的直径是选择性改变的,从而使得组合起来的金属丝装置和芯线的弹性也有选择性地变化。
15.血栓形成装置,包括:
一个穿入体内脉管系统通道到达一目标位置的导管,
一个弹性金属丝装置,包括螺旋缠绕成一级螺旋线的一定长度的金属丝,该一级螺旋线本身又螺旋缠绕成一个更大的二级螺旋线,该二级螺旋线具有一定形状,以便在未受约束时占据一定空间,而当沿导管长度方向插入并受导管约束时变平直,所述金属丝装置在其一端比另一端更具弹性。
CN98105499A 1997-03-17 1998-03-16 可由导管输送的螺旋线血栓形成装置和血栓形成方法 Pending CN1244376A (zh)

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US08/818,268 US5800454A (en) 1997-03-17 1997-03-17 Catheter deliverable coiled wire thromboginic apparatus and method

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