CN1244375A - 可由导管输送的血栓形成装置和血栓形成方法 - Google Patents

可由导管输送的血栓形成装置和血栓形成方法 Download PDF

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CN1244375A
CN1244375A CN98105498A CN98105498A CN1244375A CN 1244375 A CN1244375 A CN 1244375A CN 98105498 A CN98105498 A CN 98105498A CN 98105498 A CN98105498 A CN 98105498A CN 1244375 A CN1244375 A CN 1244375A
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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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    • A61F2/01—Filters implantable into blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
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Abstract

一种可由导管输送的血栓形成装置,包括一导管,用于穿入体内的脉管系统通道至目标部位,以及一弹性的金属丝元件,被绕成螺旋并具有某种形状,以便在不受约束时占有一定空间,当沿纵向插入导管并受其约束时拉直,为的是最终由其释放出来以扩展和占据目标位置。该金属丝元件在其外表面上被选定的位置上包括许多切口,以增加该金属丝元件的柔顺性。

Description

可由导管输送的血栓形成装置和血栓形成方法
本发明涉及用于阻止体内脉管系统或者体腔中血液流动的血管闭塞装置。
能够使血流阻塞和/或促使血液凝固，并可经过导管或其它插管引入躯体的装置，对于阻止出血或出血先兆、断开对生病组织的血液供应、减少血液流向组织及修复缺损的组织等等，是很重要的。一般应用的装置为螺旋线或者粒子，可被通过导管配置到需要阻止血液流动的目标部位。此外，各种溶液可以通过导管输送，或用于促使及加速血液凝固，或用来处理医疗问题。
过去使用的典型装置，包括有铂制的螺旋线，可被插入导管，然后使用普通的导管导线或者象“柱塞”类的其它装置，穿过导管推动到目标位置。该螺旋线装置按要求的形状被予置，一般为简单的螺旋形，以致于其在被输送至所需部位之后可恢复其原来的形状。已有技术的铂制螺旋线装置在保持其在被运送部位的位置方面经常不起作用，因而在该部位对于阻塞血液流动无效。过去使用的阻塞血流型粒子，包括聚醋酸乙烯酯(PVA)或者亲水性粒子，当其吸收血液时膨胀为更大的尺寸。当然，这种膨胀有助于阻止血液流动，设想该粒子的位置可被保持。
已有技术的用于阻止血液流动的手段相当不成熟，而且仅在获得所需要的阻止血流方面取得局部性成功。
本发明的目的在于提供一种新的改进了的血管闭塞装置，可以很容易地配置到人体中的目标部位，而且在产生凝结或者要不然就阻止血液流动方面有效。
本发明还一个目的在于提供这样一种装置，其容易制造并可按照规格及构形裁剪制作，以适应予定的配置位置。
本发明的进一步目的在于提供这样一种装置，它可被迅速和不费力地配置到躯体中的目标位置，并保持在应有的位置。
本发明的上述以及其它一些发明目的，可以按照对血栓形成装置具体说明的实施例来实现，该血栓形成装置包括一用来穿入体内脉管系统通道至目标部位的导管，以及一金属丝制的元件，该金属丝元件被绕成螺旋并具有某种形状，以便在不受约束时占有一定的体积，且当沿纵向插入导管并受其约束时拉直，为的是最终由其释放出来以扩展和占据目标位置。
根据本发明的一个方面，该金属丝元件被加工成具有朝向其远端逐渐变小的螺旋线圈直径。根据本发明的另一方面，该金属丝元件在其远端及靠近远端处的一些较小直径的螺旋线圈被紧密地缠绕，以便在插入血管中时能够阻止血液流过它。
该金属丝元件可以是单极的实心金属丝，或者是空心的金属丝。
为了控制该金属丝元件在血管中的柔性和“支持强度”，特别是在远端，可以在该金属丝元件的外部加工一些切口，且对其进行间距、宽度及深度控制，以达到所需要的柔性和形状。
本发明的上述以及其它一些目的、特性和优点，由以下与附图有关提供的详细描述考虑，将变得更清楚，其中，
图1A为根据本发明原理制成的螺旋形金属丝血栓形成装置的侧面片断剖示图；
图1B为沿图1A中1B-1B线所取金属丝螺旋线的前端视图；
图2为根据本发明原理制成的螺旋形金属丝装置的侧面片断剖示图，表示其被局部配置在导管中；
图3为根据本发明原理制成的螺旋形金属丝装置另一实施例的侧面片断视图。
参见图1A及1B，所表示的分别为已被加工成螺旋线圈的弹性金属丝4的侧面剖示片断图和端视图。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包括一较大直径的部分4a和逐渐变窄的部分4b。该螺旋线在较大直径的部分4a处扩大至与血管8的壁相接触，以将该螺旋形金属丝4夹持在应有位置。具有较窄直径的部分4b则用作螺旋形金属丝4的导向端或者远端，且其最好更加柔顺，以使插入螺旋形金属丝时将对血管壁的破坏或损伤减至最小(准备稍后进行讨论)。
螺旋形金属丝4的柔性及形状，可以通过在其外表面上(例如在图1中以放大视图10表示的那样)适当地安排一些切口9来控制，而且在1995.12.7提出的共同未决专利申请序列No.08/568.490中更详细地进行了描述，且在此被结合作为参考。通过将切口适当地既沿圆周又沿纵向分隔开，并且通过改变该切口的深度及宽度，所需要的柔性及形状便可获得。例如，一般说来，将切口靠近在一起分隔开并使其比较宽和比较深，可以提供更大的柔顺性，反之亦然。金属丝4中的切口还能增强该金属丝对血栓的形成，并且为夹持拟被沉积在血管中的凝结剂或其它药物提供位置。
金属丝4例如可由高弹性的镍钛合金丝构成，带有定向的特定切口，并且具有约为0.008至0.060英寸的外径。较大直径部分4a的直径约为3至12mm比较有利，而在部分4b处较小直径螺旋线圈的直径约为1至2mm比较有利，当此螺旋形金属丝4不受约束时两者均可被计算出来。
如在部分4b处让此螺旋形金属丝4的直径递减，可以对血液流动提供更大的阻挡和更大的金属丝阻塞强度，从而提供更大的阻塞能力，如沿图1A中1B-1B线所取的视图1B中最好看到的那样。控制螺旋线圈的锥度和各螺旋线圈之间的间隔，容许将该螺旋线圈用作有限漏泄阀或作为完全的障碍物。
此螺旋形金属丝4或可为实心金属丝或可为空心金属丝，具有上述总体尺寸。如果为空心的，且在其外表面上加工有许多切口，那么这些切口中的某些切口可以制成通过管形壁伸至内部，于是放在该管空腔中的药物，在螺旋形金属丝被放进目标部位的位置上之后，会从该切口逐渐地漏泄出去。按照这种方式，此螺旋形金属丝4的血栓形成作用，会由于药物释放作用而增大。并且，可以将能形成血栓的纤维材料配置在空心金属丝的空腔中，以增强其阻塞和凝固作用。
图2表示被局部配置在导管12中的螺旋形金属丝4的侧面片断剖示图。为了将此螺旋形金属丝4配置在脉管系统通道或其它体腔中的目标部位，可将此金属丝4穿入通常为直的导管12中，如图2所示，然后通过另一导向金属丝(未表示)或用作柱塞类型的类似装置穿过该导管对螺旋形金属丝施加力，使其从导管远端伸出然后在该处扩张，以将其本身安置在目标位置。当被配置在躯体中血液流过的目标部位时，螺旋形金属丝4的作用是使血流减慢而让其凝结或凝成块，而且最终阻止其进一步流动。为了帮助此凝固过程，可以将溶液形式的凝结剂随同螺旋形金属丝4的配置一起，通过导管12输送到目标部位。另一种办法是，可将此溶液配置在空心的螺旋形金属丝4中，经过伸过管壁的侧向切口逐渐从管中漏泄出去，如上予先讨论过的那样。
图2所示螺旋形金属丝4的实施例，包括变窄了的远端部分4b，其中的绕组被紧紧地缠绕到如此程度，以至相邻的绕组邻接在一起。使用这种高密度堆积的绕组，血流实质上已被阻止，甚至在其发生凝结或凝成块之前。
图3表示金属丝32的侧面片断图，在其外表面上加工有切口36。此金属丝32或可为实心或可为空心，且可被加工成具有渐缩的远端的螺旋线圈，如图1A所示。如早已描述过的那样，这些切口36可被设置来控制金属丝的柔性及沿其长度的形状。这些切口的形成，或通过锯齿状切削或通过三维蚀刻，如美国专利US.NO5,106,455中描述的那样。
射线透不过的带子40，可以沿金属丝32的长度方向在予定的位置上被缠绕在其周围，以容许跟踪该金属丝在体内的脉管系统通道中的运动。例如由涤纶或其它聚酯制的可形成血栓纤维44，在一定部位(最好是在制成切口的部位)被固定在金属丝32上。该纤维44可被系在金属丝32上，通过粘合剂固定、熔合或其它公知的连接方法。这些纤维能够促进流过金属丝32的血液的凝固和凝成块，这当然是所期望的结果。
应当理解，上述结构只是对本发明原理申请的说明。为数众多的改变和其它可能的结构，均可由本领域的技术熟练人员作出，而不离开本发明的精神和范围，而且所附的权利要求书试图覆盖住这种改变和结构。

Claims (20)

1.一种血栓形成装置，它包括：
一导管，用于穿入体内的脉管系统通道至目标部位，以及
一弹性的金属丝装置，被成形为其不受约束时占有一定空间，且当沿纵向插入该导管并受其约束时拉直，为的是最终由其排出以扩展并占据目标位置；所述金属丝装置在其外表面上被选定的位置上包括许多切口，以增加该金属丝装置的柔顺性。
2.如权利要求1所述的装置，其中所述的金属丝装置被加工成直径为朝向其远端逐渐变小的螺旋线圈。
3.如权利要求2所述的装置，其中在其远端或靠近远端处的一些较小直径的螺旋线圈被紧密地缠绕，以便在插入血管中时能够阻止血液流过它。
4.如权利要求1所述的装置，其中所述的金属丝在其远端附近每单位长度上包括比其其它部位更多的切口，以使其远端更加柔软。
5.如权利要求1所述的装置，进一步包括有配置在切口之中向该金属丝外伸展的许多段纤维，以帮助形成血栓。
6.如权利要求5所述的装置，其中的纤维是由选自由涤纶和丝绸组成的一组材料制成的。
7.如权利要求1所述的装置，其中所述的金属丝为实心的。
8.如权利要求1所述的装置，其中所述的金属丝为围绕其中央空腔带有侧壁的空心的。
9.如权利要求8所述的装置，其中至少上述切口的某些切口是通过该侧壁伸向该中央空腔的。
10.如权利要求9所述的装置，进一步包括有配置在该中央空腔中的药物，以便在该装置被配置在目标位置时，可经过穿过该侧壁伸展的一些切口从中漏泄出去。
11.如权利要求8所述的装置，进一步包括有配置在该金属丝空腔中的纤维，以帮助形成血栓。
12.如权利要求2所述的装置，其中在近端处的螺旋线圈直径约从3至12mm，而且其中远端处的螺旋线圈直径约从1至3mm。
13.如权利要求1所述的装置，其中所述的金属丝装置是由镍钛合金制成的。
14.如权利要求13所述的装置，其中所述的金属丝装置具有约从0.008至0.060英寸的直径。
15.一种血栓形成装置，它包括：
一导管，用于穿入躯体中的脉管系统通道至目标部位，以及
一弹性金属丝，被绕成螺旋并具有某种形状，以便在不受约束时占有一定的体积，且当沿纵向插入导管并受其约束时拉直，为的是最终由其排出以扩展和占据目标位置，所述金属丝被加工成具有直径为朝向其远端逐渐变小的螺旋线圈。
16.如权利要求15所述的装置，其中在远端处及靠近远端处的一些较小直径的螺旋线圈被紧密地缠绕，以便在插入血管中时能够阻止血液流过它。
17.如权利要求15所述的装置，其中所述的金属丝为实心的。
18.如权利要求15所述的装置，其中所述的金属丝为围绕其中央空腔带有侧壁的空心的。
19.如权利要求18所述的装置，其中所述的金属丝包括许多切口，至少其中某些切口是通过该侧壁伸向该中央空腔的。
20.如权利要求19所述的装置，进一步包括有配置在该中央空腔中的药物，以便在该装置被配置在目标位置时，可经过穿过该侧壁伸展的切口从中漏泄出去。
CN98105498A 1997-03-17 1998-03-16 可由导管输送的血栓形成装置和血栓形成方法 Pending CN1244375A (zh)

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US5911717A (en) 1999-06-15
DE69831889D1 (de) 2006-03-02
ATE306872T1 (de) 2005-11-15
TW387803B (en) 2000-04-21
CA2232186A1 (en) 1998-09-17
AU5933298A (en) 1998-09-17
KR19980080321A (ko) 1998-11-25
EP0865772B1 (en) 2005-10-19
JP3325828B2 (ja) 2002-09-17
CA2232186C (en) 2006-05-16
EP0865772A1 (en) 1998-09-23
DE69831889T2 (de) 2006-04-20

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