CN1442121A - 血管内限流器 - Google Patents

血管内限流器 Download PDF

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CN1442121A
CN1442121A CN03102917A CN03102917A CN1442121A CN 1442121 A CN1442121 A CN 1442121A CN 03102917 A CN03102917 A CN 03102917A CN 03102917 A CN03102917 A CN 03102917A CN 1442121 A CN1442121 A CN 1442121A
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K·安普拉茨
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Abstract

一种血管内限流器，包括一由多条金属股线编织而成的具有一近端和一远端的编织金属织物，每一端均具有固定连接在编织金属织物上的每一端的固定件，由此将股线聚集在一起并阻止股线的散开，编织金属织物具有一在血管中起限制作用的展开的预定构形，展开的预定构形的形状为预定厚度的圆筒体盤狀物，盤狀物具有至少一穿越其厚度的管腔并可变形为一较小剖面尺寸从而可经病人身体中一通道输送，编织金属织物具有记忆特性，从而当不受限制时该装置可自然地回复至所述展开的预定构形。本发明的装置放置在主肺动脉中可限制肺部血压，当放置在一输送导管内后，当它自输送导管被送出时其直径可扩大而成为其中具有一或多条纵向通道或通路的盤狀装置。

Description

血管内限流器
(1)技术领域
本发明总的涉及用于治疗某些医疗情况的血管内装置，更具体地说，涉及一种在装置了限流器处的下游降低血压的血管内限流器。
(2)背景技术
对于正常的心脏，其右侧泵血至肺部，这是个相当容易的任务，而心脏的左侧则泵血至整个身体，是个较困难的工作。因此，左心室(泵腔)的血压一般来说大约是右心室血压的5倍，且左心室的壁比右心室的壁厚。许多心脏缺陷中有一种是血过量流入肺部。很多缺陷涉及中隔内的孔允许血液自高压左侧流到低压右侧。这会使右心室血压增高而导致太多的血泵到肺部。身体对此的自然反应是收缩或使窄肺部的血管变窄以尽力限制这些过量的血流。超过一段时间后，肺动脉的收缩或变窄会导致肺动脉因工作负荷增加而加厚，最终使较小的肺动脉关闭而进一步减少血液流入肺部。
流入肺动脉的由左心室至右心室的血液分流越来越少，最后阻力使分流反转，即发生由右到左的分流。这个过程称之为肺血管病变，最后因血氧浓度下降而形成黑里透红的颜色以及病人的血红蛋白浓度的增加。长期肺动脉高压造成的损伤一般来说会造成心脏缺陷以后无法恢复。患有唐氏综合症的儿童倾向发展为肺血管病变，因为这种病使他们心脏的孔较大，小的肺动脉较少以及通道较小，对此一般都在较早的时候进行修补术，尽管做手术的时间要看心脏缺陷的具体情况而定。
例如，在心室中隔缺陷(VSD)的情况下，特别是有多个开口的情况下，不可能用外科手术修补该缺损。对于新生婴儿来说，他们未必经受得住为修补多个″瑞士乳酪″状中隔缺陷而必需的心脏开刀手术。对出生后头几个月患有VSD幼儿发展成充血性心力衰竭的症状时，就有可能要试用创伤较小的治标性手术来治疗。治标性手术可以减小缺陷的危险，而不能彻底治疗起病的根源。一种治标性治疗是肺动脉(PA)束扎术，用以阻止过量的血液自左心室通过缺陷分流入右心室。
对于患有肺动脉不正常高压的幼儿或儿童，外科手术经常被认为太危险，但肺动脉束扎术可能是会有效的。这种手术需要外科医生用束带束紧肺动脉，从而减少血液流到肺部，并可防止身体因需要而形成它自己的限制。如果成功的话，肺动脉高压的发展可以减缓或停止，并可能在以后补做孔的修补术。
PA束扎术的创伤虽然比心脏开刀手术小，但仍然需要用开胸手术暴露肺动脉，以将缩窄性束带缝在肺动脉周围。该PA束带减小肺动脉的直径，由此限制泵入肺部的血流量。这样一种手术可将原来的血流量减少一半至三分之一。在束带的远端，由于体积的缩小，肺动脉血压比束紧前通常可以降低50％-70％。
虽然肺动脉束带的危险比心脏开刀手术小，但它仍具有通常外科手术的危险性，诸如出血、感染、肺栓塞、心力衰竭等。肺动脉束扎术的危险是束带束得太紧或是太松。如果束得太紧，太少血流到肺部会使病人发青。如果束得太松，不能消除肺部的充血，因此不能保护肺部防止肺部受损伤以及肺血管病变。
(3)发明内容
因此，本发明的目的是提供一种血管内限流装置，可供一种比目前肺动脉束扎术创伤为小的非手术方法来限制血流到患先天性心脏疾病的病人肺部，该疾病可导致肺血管病变，诸如：在血流限制置于各肺动脉的地方造成左侧发育不良综合症；并且没有手术的风险，不痛或不会在胸部留下较大的疤痕。
按照本发明，本发明提供了一种适于放置和固定在血管系统内的装置，利用一经血管的方法限制或减少血流到肺部、肝或其他器官。它包括一由多股金属线编织成金属织物的可伸缩的医疗装置，该装置具有一近端和一远端，每一端均具有将梭织金属织物固定的夹持件，由此把金属线聚集在一起阻止金属股线散开。编织的金属织物具有一在血管中起限制作用的展开的预定结构，该展开的预定结构呈预定厚度和外径的圆盘状，并具有至少一贯通该盤狀物厚度的管腔。以编织金属织物形成的盤狀物可以变形形成为较小的剖面尺寸以由一导引导管经由病人身体中一通道加以运送。该编织金属织物具有记忆特性，从而使装置自然地回复至其展开的预定盘状结构。
该装置适于变形为较小的剖面尺寸以置于一导管内，该导管可在血管系统前进直到其远端位于一所要求的释放位置，例如当治疗肺血管病变时，越出主肺动脉的开口或进入单独的右室和左肺动脉。然后使该装置从输送导管的末端出来并并在回复自然尺寸后，留存在肺动脉内并限制由右心室通过管腔输送的血液量。本发明的限流器还发现可应用于其他各种医疗状况，这将在后面作描述。
根据本发明的进一步特征，除了用装置的管腔方法外，盤狀装置的空心内部可包括一纤维物料嵌入物以增强对血流的堵塞使之只能经由装置的管腔进行流动。
(4)附图说明
对于本领域的技术人员来说，本发明的其他特征点和优点可从下面对较佳实施例，特别是结合附图所作的详细描述而得以一清二楚：其中
图1是用作可伸缩的医疗装置的一展开状态的限流器的立体示意图；
图2是图1所示装置的俯视图；
图3是图1所示装置的侧视图；
图4是图1所示装置的后视图；
图5是图1所示装置变形为较小剖面尺寸状态的侧视图；
图6是安装在心脏的主肺动脉中作为一限流器的图1所示装置的解剖学上的示意图。
(5)具体实施方式
本发明提供了一种通过经皮导管的引导，用于治疗患有不正常血管系统结构的病人，诸如在心脏左右侧间有分路、大动脉移位(TGA)、Fontan术后经肝(肝穿)门体静脉的分流以及蛋白质流失肠道病。
参见图1，当装置处于未受约束的自然状态时，它包括一具有预定展开直径的相对端12和14以及一在所述两端之间中空的中部16的盤狀装置10。形成所述装置10的金属织物包括多股股线，该多股股线编织为一管状结构，然后以Curtis Amplatz的美国专利6,123,715所描述的方式在一模具中加热定形，此专利内容援引在此以供参考。
如美国专利6,123,715中所述，组成金属织物的股线最好由具有弹性的金属或金属合金制成，而且可以通过加热使编织物形成所需的形状。因此，所述金属股线可以是钴基的、通常称之为Elgiloy的低热膨涨合金、也可以是从Haynes国际公司购得的以″Hastelloy″商标注册的镍基高温高强度″超合金″、或可加热处理的镍基合金，诸如国际镍公司生产的Incoloy、以及大量不同等级的不锈钢。当这些材料置于模具中受一规定时间的高温处理时均可具有一合适的变形量。所谓的能记忆形状的合金诸如Nitinol特别适合用于本发明。
当夹环外端的股线被切断之前，夹环以预定间隔位置夹在管状结构上之后，一段具有预定数目股线和所要求的纬纱的管状金属编织物自其较长部分被切断。请参见图5，夹住的夹环被分别标上标号18和20且每一个夹环均包括一内螺纹孔，其目的将在下面进行阐述。
一旦获得一合适尺寸的金属织物，它将被变形以与模具表面形成一致。将织物放置在模具中的作用是使金属织物股线的相关位置由最初的位置重新定位至第二种位置，即一经重新定位的结构。在本发明此例中，模具呈圆筒形，具有预定的长度和直径，这样，在其内成形的编织装置的尺寸大小恰好可放置在一诸如肺动脉的管状血管内。当编织装置放置在模具中后，该模具和装置被加热足够时间以使带有夹持端的管状织物形成模具的形状。加热处理主要取决于制成股线的金属或金属合金的特性，其时间和温度要使装置在模具中形成模具的形状。
对构成本发明限流装置的方法要求更详细资料的人士请参看Amplatz的专利6,123,715。
为形成装置10，在组件被放置在模具中之前将一或多条圆柱形杆(图中未示)穿过编织物。当圆柱形杆在加热处理步骤后被取出时，所述装置具有通过装置端部12所形成的孔26和28，以及通过装置第二端14所形成的孔26和28。孔22与孔26纵向对齐，孔24与孔28纵向对齐。虽然图1-4所示的装置具有两个穿透该装置厚度的管腔，但是，只要孔的有效剖面面积可提供穿过孔时达到所要求的压降，孔的数目可以多些或少些。
为了阻止液流经限制器装置10的管腔以外的地方流过，可以在两端之间设置一诸如聚酯织物的非金属纤维物料，但必须谨慎以使该织物不会干扰孔22-28所形成的开口22-28。而且还发现可以在装置的外围包裹一聚四氟乙烯(PTFE)织物带30以阻止组织向内长入。织物带30的试用可以使限制器装置10在进行缺损修补术之前容易取出。
给病人做肺动脉绷扎术时，装置10首先与一诸如缆线或一细长导线的推进装置31的螺纹远端接上，接到夹件18或20中的一个螺纹孔，然后拉入一用于将该装置10装进一导引导管的近端的管状装置载件中，由此将装置纵向延伸从而大大减小其外部直径。一旦该装置以及与其连接在一起的推进装置31容入导引导管的管腔内时(图6中编号32)，导引导管经由血管系统进入右心房(RA)，然后经由三尖瓣阀进入右心室(RV)，然后，再进入主肺动脉(MPA)或右肺动脉(RPA)或左肺动脉(LPA)之中。当推进装置31的远端处于MPA、RPA和LPA其中之一时，推进装置31用于将装置10自导引导管32的远端边界推出来，于是装置10弹回到其自然未受约束的位置，在此位置，该装置横向留存于所选择的肺动脉中由此限制血液自右心室流入肺部。只允许血流经该装置10的厚度所形成的开口22，24和26，28。通过适当地制定开口的大小，右肺动脉(RPA)和左肺动脉(LPA)的血压可保持在不会导致充血性心力衰竭症状的水平。
该装置可以留在幼儿的心室中一段足够长的时间，直到认为是进行纠正中隔缺陷术的较佳的时候。此时，装置10可通过导管技术或外科手术取出。包裹该装置外围的织物带30有助于减少组织的内生长，使装置10在进行中隔缺陷修补术时容易取出。
在没有限制的情况下，用于构成装置10的管状编织物的直径的松弛度可大约为30毫米，斜度可大约为50°，纬纱可大约为72。在此条件下，可适当地在装置10的范围内放进一纤维物质来提高其闭锁性能。然而我们发现，若将编织纬纱增加至每线性英寸144时，就可以不需要设置这样一种纤维物质。编织物的本身密度足以阻挠除流经穿越该装置的厚度所预成形开口之外的其他血流。
虽然装置10最好是模制的，以使其具有一薄盘状或一正圆筒体的结构，但是也发现在某些应用中人们要求该装置的一端表面稍微凸出，而其对端表面则稍微凹入，如图3的侧视图所示。
至此，对本发明的该装置已联系它用于控制肺动脉的血压而作了以上的描述，并以治疗血管病变显示了本发明的用途，但是，它还可用于进行其他的医疗过程。对患有名为大动脉移位(TGA)心脏缺陷的新生儿有可能称为″气囊型导管中隔切开术″或稍有变化的称为″刀刃中隔切开术″的″Rashkind″手术。在气囊型导管中隔切开术中，其远端处具有一未膨涨气囊的导管被插入血管系统中并推向心脏。使该气囊型导管通过心房中隔中的称为″卵圆孔″的开口进入左心房。所述气囊然后被充气膨涨并撤回，在它被拉回至右心房时撕裂心房中隔。扩大后的开口可以增加流到主动脉然后再流到身体的含氧血流。
本发明的该装置可以做到更精确地控制血流通过心房中隔的撕裂处。通过选定一具有合适尺寸的管腔的限流装置，可实现更精确地控制含氧血流向主动脉的流动。装置10可以类似于以上所描述的将装置放置在肺动脉中的方式插入被气囊扩大的开口中。
该装置10还可用于治疗因经肝门体静脉分流而患有门静脉高压症的病人。这种病症可导致异位静脉曲张以及胃肠道出血。通过降低高压门脉系统中的血压，可以提高对大肝静脉堵塞的控制水准。该操作包括将一导管通过右颈内静脉进入右肝静脉，然后将一支针先通入肝门静脉。管道被扩大以使装置10插入用于保持不闭合。
本发明还可应用于目前其他的外科手术中的开孔式Fontan术中。患有一种先天性心脏不正常的幼儿只剩下一个心室起作用，输血到肺部的右心室可能不起作用。Francois Fontan博士用一种外科术来解决问题：使流过从身体返回的血液的腔静脉直接与肺动脉连接而因此使含有氧气。然而，很多被治疗的病人发生一种称为蛋白流失的肠道疾病。这种疾病的症状包括腹部、胫和踝肿胀、腹泻以及腹部不适。在药物治疗失败时，只能采取在Fontan通道中穿一孔的手术，以便实现自心脏右边通到左边的分流。
本发明允许以一最小的侵入性导管手术来形成一孔，然后在孔中安装一合适尺寸的限流器，通过防止闭塞来更好地控制流经孔的血流量，改善病人的症状以及引起的青紫症。
为遵从专利规则，已在此对本发明作了详细的描述，给本领域的技术人员提供了需要的资料以应用新的原理按要求构造和应用专门的构件。然而，应该理解，在不脱离本发明范围的情况下，本发明完全可以通过种种不同构件和装置来实施，无论对设备还是对操作过程都可以作出各种变化或者种种改型。

Claims (23)

1.一种可伸缩的医疗装置，其特征在于，该装置包括一由多条金属股线编织而成的具有一近端和一远端的编织金属织物，每一端均具有固定连接在所述编织金属织物上的每一端的固定件，由此将所述的股线聚集在一起并阻止所述股线的散开，所述编织金属织物具有一在血管中起限制作用的展开的预定构形，所述展开的预定构形的形状为预定厚度的圆筒体盤狀物，所述盤狀物具有至少一穿越其厚度的管腔并可变形为一较小剖面尺寸从而可经病人身体中一通道输送，该编织金属织物具有记忆特性，从而当不受限制时该装置可自然地回复至所述展开的预定构形。
2.如权利要求1所述的医疗装置，其特征在于，至少一固定每一端的所述固定件具有一与一输送装置旋转连接的螺纹孔。
3.如权利要求2所述的医疗装置，其特征在于，该医疗装置还包括一闭塞用的纤维物料，该物料置于由所述编织织物形成的中空中心部内。
4.如权利要求1所述的医疗装置，其特征在于，所述金属织物是由从包括不锈钢、镍钛合金以及钴铬镍合金所组成的一组材料中所选择的合金制成。
5.如权利要求4所述的医疗装置，其特征在于，该医疗装置还包括一闭塞用的纤维物料，该物料置于由所述编织织物所形成的中空中心部内。
6.如权利要求1所述的医疗装置，其特征在于，该医疗装置还包括一闭塞用的纤维物料，该物料保留在置于由所述编织织物形成的中空中心部内。
7.一种可伸缩的医疗装置，其特征在于，该装置包括一管状编织金属织物，该织物包括多条编织股线并具有一第一端和一第二端，每一端均具有一固定于所述金属织物并由此将所述股线聚集在一起及阻止所述股线散开的夹持件，所述金属织物具有一可经病人身体中一通道输送的可伸缩结构，它是呈圆筒体盤狀的展开的预定结构，以在身体器官中限制血流流动。
8.如权利要求7所述的医疗装置，其特征在于，所述两相对端是凸出的。
9.如权利要求7所述的医疗装置，其特征在于，所述第一端和第二端之间包含一非金属纤维物料。
10.如权利要求9所述的医疗装置，其特征在于，所述第一端和第二端均包括至少一孔，在所述第一端和第二端中的孔纵向对齐，而且不被所述纤维物料所闭塞。
11.如权利要求10所述的医疗装置，其特征在于，该医疗装置还包括一非金属化纤维物料制成的包裹在所述圆筒体盤狀装置外围的带。
12.如权利要求11所述的医疗装置，其特征在于，所述的带由聚四氟乙烯制成。
13.一种可伸缩的医疗装置，其特征在于，该装置包括一编织金属织物，该织物包括多条编织股线并具有一近端和一远端，每一端均具有一固定于所述管状金属织物以将所述股线聚集在一起及阻止所述股线散开的夹持件，所述编织金属织物具有一可在身体器官中限制血流的展开的预定构形，所述展开的预定构形为盘状物并可变形为一较小剖面尺寸从而可以经病人身体中的一通道被输送，其中，所述展开的预定构形包括两个展开直径的端部和一中空中心部，所述展开直径的部分的直径可横跨病人的肺动脉，所述端部和中部包括预定尺寸小于展开的直径部分的开口，所述编织金属织物具有记忆特性因而在不受限制时有助于该医学装置可自然地回复至所述展开的预定构形。
14.如权利要求13所述的医疗装置，其特征在于，其中一所述夹持件具有一适于旋转地接纳一输送装置的螺纹孔。
15.如权利要求13所述的医疗装置，其特征在于，该医疗装置还包括一包含在所述中空中心部的闭塞纤维。
16.如权利要求13所述的医疗装置，其特征在于，所述金属织物是由从包括不锈钢、镍钛合金以及钴铬镍合金所组成的一组材料中所选择的合金制成。
17.如权利要求13所述的医疗装置，其特征在于，该医疗装置还包括一非金属纤维物料制成的包裹所述中部外围的带。
18.如权利要求17所述的医疗装置，其特征在于，所述带由聚四氟乙烯制成。
19.一种可以降低患有中隔缺陷的病人的肺部受到的高血压的方法，其特征在于，该方法包括以下步骤：
(a)提供一编织的管状限流器装置，该装置的呈展开状态时的尺寸为可横跨病人肺动脉而其细长伸展状态尺寸适合置于一管状承载件的管腔内；
(b)将所述限流器装置装在一推进装置的远端；
(c)将所述推进装置插入一管状承载件的管腔内并在所述推进装置的近端施加拉力使所述限流器装置进入所述承载件的管腔中；
(d)使一导引导管循着血管内的路线前进直到该导引导管的远端进入肺动脉的孔口为止；
(e)将所述承载件连接在所述导引导管上并用推进装置将限流器推到一肺动脉中所要求的位置；
(f)将所述限流器装置自所述导引导管的远端推出，所述限流器装置旋即自动展开成其展开状以留在所述肺动脉中；以及
(g)使所述推进装置自所述限流器装置上脱开并将所述推进装置和导引导管自该病人身体撤回。
20.如权利要求19所述的方法，其特征在于，所述肺动脉为主肺动脉、右肺动脉和左肺动脉其中之一。
21.一种患有TGA的病人的治疗方法，其特征在于，该方法包括以下步骤：
(a)进行Rashkind手术使所述心房中隔的一自然开口扩大；以及
(b)将权利要求1所述的装置装在步骤(a)的扩大的开口中。
22.一种患有肝门脉高压的病人的治疗方法，其特征在于，该方法包括以下步骤：
(a)在所述右肝静脉和门静脉之间形成一分流道；以及
(b)将权利要求1所述的装置装在所述分流道中。
23.一种治疗病人以减小Fontan术后蛋白质流失肠道病的方法，其特征在于，该方法包括以下步骤：
(a)在手术中造成的Fontan通道中形成一孔；以及
(b)将权利要求1所述的装置装在所述孔中。
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