CN1447669A - 用于过滤从心房附件流出的血液的可膨胀植入装置 - Google Patents

用于过滤从心房附件流出的血液的可膨胀植入装置 Download PDF

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CN1447669A
CN1447669A CN01814305A CN01814305A CN1447669A CN 1447669 A CN1447669 A CN 1447669A CN 01814305 A CN01814305 A CN 01814305A CN 01814305 A CN01814305 A CN 01814305A CN 1447669 A CN1447669 A CN 1447669A
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托马斯·E·博里洛
迪安·彼得逊
格莱格·S·萨顿
杰弗里·韦尔奇
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Abstract

用于过滤流过心房附件口的血液的植入装置，具有组成构件，其中，一个或多个组成构件可膨胀。具有组成构件的装置在处于未膨胀状态时有紧凑尺寸，适于通过皮内装置传送到心房附件位置。可膨胀的组成构件就地膨胀，以便展开该装置。该装置可以有足够短的轴向长度，这样，该装置的大部分或几乎全部长度都装入口区域内。在该装置中的可膨胀组成构件可以包括血液可透过的过滤元件。该装置可以展开，从而使该组成构件盖住该口，以便引导血液流过该过滤元件。用于该装置中的过滤元件的孔尺寸分布可以选择为能够滤出大小用危害的血栓。该过滤元件可以嵌入弹性材料中，这样，孔尺寸分布保持基本不受装置构件膨胀的影响。安装在组成构件上的锚固件与包围该装置的组织啮合，并使该装置保持就位。锚固件可以包括可充气的锚固件，它与心房附件的内壁啮合。

Description

用于过滤从心房附件流出的血液的可膨胀植入装置
本申请要求申请日为2000年8月18日的美国临时申请No.60/226461、申请日为2000年9月21日的美国临时申请No.60/234112以及申请日为2000年9月21日的美国临时申请No.60/234113的优先权，这些文献都整个被本文参引。
发明的背景技术
发明领域
本发明涉及一种可以植入到心房附件内的植入装置，用于过滤在心房附件和心脏的相关心房之间流动的血液，以便防止血栓离开心房附件进入人体的血液循环系统。
相关技术的说明
多种心脏病(例如冠状动脉疾病、二尖瓣疾病)对病人心脏有着各种不利的影响。某些心脏疾病例如二尖瓣疾病的不利影响是心房(或心耳)纤颤。心房纤颤可能导致抑制心脏输出。与心房纤颤一起出现血栓栓塞(即血凝块微粒)现象的发病率很高，左心房附件(LAA)经常是栓(微粒)的源头。
血栓(即血凝块)在LAA中形成可能是由于在纤颤和未充分排空的LAA中郁积。汇集在心房附件中的血液导致形成血凝块。血凝块自身可以积聚和累积。或大或小的血凝块部分可能断开，并离开该心房附件进入心房。然后，血凝块部分能够进入人体的血液循环系统，并使远处的血流发生栓塞。
血凝块部分从心房附件运动到人体血液中将引起严重医疗问题。来自左心房和心室的血液流向心肌、大脑以及其它身体器官，并向它们供给所需的氧和其它养料。由左心房附件中形成的血凝块产生的血栓可能堵塞动脉，血液通过该动脉流向身体器官。该堵塞使得器官组织不能获得正常的血流和氧供给(缺血)，根据所涉及的身体器官，将引起缺血症状，例如心脏病(心肌缺血)和中风(脑组织缺血)。
因此，重要的是发现一种能够防止血凝块在左心房附件中形成的装置。还有，重要的是发现一种装置，该装置能够防止由已经在心房附件中形成的血凝块而产生的断开部分或血栓通过血流传播到心肌、大脑或其它身体器官中。
美国专利5865791(下文称为专利’791)涉及减小心脏中的血瘀区域，最终减少血栓在该区域的形成，尤其是在有心房纤颤的病人的心房附件内。尤其是，专利′791涉及用于在一定位置粘住心房附件的的方法和装置，这将防止随后形成血栓。在专利′791中，通过将该附件拉起并将一个环环绕该附件以形成一个袋，再将它从心脏的其余部分上切下，从而将该附件从心房上取下。
美国专利5306234涉及一种通过手术封闭心房和心房附件之间的通道，或者可以选择割断心房附件的方法。
近来提出的一些治疗方法涉及在心房附件中植入塞子类型的装置，以闭塞血液从该心房附件的流动。
用于避免血栓栓塞病症(例如心脏病、中风和其它缺血病症)的预防治疗方法涉及从流出心房附件的血液中过滤出有害的血栓。共同待审和共同拥有的美国专利申请No.09/428008、美国专利申请No.09/614091、美国专利申请No.09/642291以及美国专利申请No.09/697628介绍了可以植入到心房附件内以便过滤从该心房附件流出的血液的过滤装置，这些文献整个被本文参引。该装置可以利用普通的心导管插入法来传送给心房附件。这些方法可以包括贯穿中隔的导管插入法，该方法涉及穿刺心房间隔。
导管和植入装置较大，这可能需要在中隔中进行较大穿刺。较大的导管和装置可能在传送或植入过程中损伤身体组织。对身体组织的损伤可能引起外伤，延长复原时间，增加并发症的危险，并增加病人的护理费用。而且，不同病人的心房附件的形状和尺寸可能不同。
因此，希望提供一种植入装置，该植入装置较小，且该植入装置能够通过较小尺寸的导管传送给心房附件。因此，还希望提供一种植入装置，该植入装置的尺寸能够就地进行调节，以适应心房附件的尺寸。
发明简介
本发明提供了植入装置和方法，该装置和方法可以用于过滤在心房附件和心房之间流动的血液。该装置设置成防止形成于心房附件中的血凝块释放到身体的血液循环系统中。
这里所述的所有植入装置都有可调节的尺寸。紧凑或狭窄的尺寸可以用于通过皮内装置传送给心房附件，例如通过心导管插入法。该装置包括尺寸调节机构，该尺寸调节机构使得装置的尺寸能够就地扩大至与心房附件的尺寸相符的膨胀尺寸。
在一个植入装置实施例中，膨胀内部构件布置在隔膜管内部。该内部构件有刚性部件，当该内部构件膨胀时，该刚性部件向外挤压或推动隔膜管的侧面。该内部构件可以自膨胀，或者例如可以通过可充气气球而膨胀。当内部构件处于折叠形状时，该装置有紧凑尺寸，适于传送到和插入心房附件内，例如通过心导管插入法。当充分展开以便使用时，隔膜管的封闭端盖住心房附件的口。形成隔膜管的封闭端的过滤元件或部件将大小用危害的血栓从流出心房附件的血液中滤出。通过使内部构件膨胀，以便使隔膜管的侧面压靠心房附件的内壁，从而可以使该装置保持就位。
另一植入装置实施例可以有其它类型的可充气或可膨胀构件，该可充气或可膨胀构件使得该装置有用于装置传送的紧凑尺寸，且该可充气或可膨胀构件能够随后就地扩大，以便使该装置的尺寸与心房附件的尺寸相符。
装置可以有较短的轴向长度，该轴向长度与口的长度的一部分相当或相同。较短轴向长度的装置可以有较薄的可膨胀或可充气构件。该较薄的可充气构件的横截面形状例如可以类似于蘑菇帽、药丸盒或圆环形管等。该构件可以包括血液可透过的合适过滤元件，用于将大小有危害的血栓从血流中滤出。该过滤元件可以位于该较薄构件的中心或者可以偏离该构件的中心。当展开时，该较薄构件盖住心房附件的口，并引导流过该口的全部血液都通过过滤元件。该构件可以合适设计成防止有不希望的流动槽道(例如环绕该装置的边缘)，未过滤的血液可以通过该流动槽道在附件和心房之间流动。该构件可以有安装在它的外周的锚固件。这些锚固件可以为销钉、钩子、倒钩、防止损伤的球形顶端或者其它用于与组织啮合的合适结构。该锚固件与口的内壁啮合，从而固定展开的装置的位置。某些装置的轴向长度可以稍微长于该口的长度，这些装置的锚固件可以布置在可膨胀构件的后面部分上，以便与心房附件的、通向口的颈部区域的内壁组织啮合。
具有可膨胀或可充气构件的其它装置可以有较长的轴向长度，该轴向长度与心房附件的长度的基本部分相当或相同。较长轴向长度的装置可以有第一构件，该第一构件设计成盖住心房附件的口，并过滤从该心房附件流出的血液。该第一构件可以选择为可膨胀或不可膨胀。在任意情况下，装置中的可膨胀的第二构件可以用于帮助将该装置固定在它的展开位置。该可膨胀的第二构件通常布置在心房附件的管腔或内腔中。该可膨胀的第二构件可以为自膨胀，或者例如可以通过气球充气而膨胀。可膨胀的第二构件可以有用于与心房附件的内壁啮合的部件，例如附加的锚固件。这些锚固件可以是销钉、钩子、倒钩、防止损伤的球形顶端或其它用于与壁组织啮合的合适结构。该可膨胀的第二构件另外或者可以选择包括可充气的锚固件。当充气时，这些可充气的锚固件直接与心房附件的内壁啮合，并产生阻止改变展开装置的位置的阻力。
在可膨胀的植入装置中可以包括具有预定孔尺寸分布的过滤元件，以便将大小用危害的血栓从血流中滤出。该过滤元件可以设置成使得它们的孔尺寸分布并不会在装置的膨胀过程中产生较大变化。在该结构中，过滤元件可以嵌入弹性隔膜中。该隔膜设计成这样，当装置膨胀时，该过滤元件的形状由于装置尺寸增大而伴随发生的拉伸大部分通过弹性隔膜来承受。过滤元件自身尺寸以及它们的预定孔尺寸分布保持基本不变。
通过附图和随后的详细说明，可以更清楚本发明的其它特征以及它的特性和各种优点。
附图的简要说明
图1a是根据本发明的原理，表示尺寸可调的植入装置在它的尺寸狭窄紧凑以适于通过心导管插入法传送时的剖视图。
图1b是表示图1a的植入装置在心房附件中展开时的剖视图。所示植入装置有隔膜管，该隔膜管有用于过滤血液的过滤元件。根据本发明的原理，该装置通过膨胀的内部结构而保持就位。
图1c是根据本发明的原理，表示在它处于膨胀形状时膨胀的内部结构的一个实例。
图2是表示在心房附件中展开的另一植入装置的局部剖视图。根据本发明的原理，所示植入装置有用于过滤血液的过滤元件，并通过自膨胀的内部结构而保持就位。
图3a是表示当传送的植入装置位于口内时的示意图。根据本发明的原理，该装置有较薄的可膨胀结构，它可以用于盖住心房附件的口，这样，将迫使附件和心房之间的血流经过装置中的过滤元件。
图3b和3c是表示图3a的植入装置的可膨胀结构的形状的实例的剖视图。
图4示意表示了根据本发明的原理，图3a的植入装置在它的可膨胀结构充气时的尺寸增加。
图5a是表示具有布置在心房附件中的可膨胀远端结构的植入装置的局部剖视图。所示植入装置的近端结构可以用于盖住心房附件的口，以便使血流经过过滤元件。根据本发明的原理，该装置通过具有可膨胀锚固件的远端结构而保持就位。
图5b是根据本发明的原理，表示具有可膨胀结构的另一植入装置的侧视图，在该可膨胀结构中，当盖住口和将该装置固定就位时，单个膨胀结构有图5a中所示的近端结构和远端结构的功能。
图5c是图5b中所示的植入装置的平面图。
图6是根据本发明的原理，表示预定尺寸的过滤元件和安装在该过滤元件上的弹性膜的示意图，该过滤元件有孔，使得大小有危害的血栓不能透过。
优选实施例的说明
尽管心房纤颤可能导致血液汇集到左心房附件中，且本发明将主要用于左心房附件，但是本发明也可以用于右心房附件，且通常用于布置成跨过身体内的任意小口，其中，允许血液通过或流过，但是能基本防止血凝块从心房附件中溢出和进入血流中。
这里所述的植入装置具有可调的尺寸。尺寸紧凑或狭窄时用于通过皮内装置传送给心房附件，例如通过心导管插入法。该装置包括尺寸调节膨胀机构，该尺寸调节膨胀机构使得装置的尺寸能够就地放大至膨胀尺寸。希望植入装置能够正确进行可控制的膨胀。例如，装置的过滤元件必须正确定心或布置成跨过心房附件口，以便使该装置能够合适地截断和过滤流出心房附件的血液。膨胀机构使得植入装置的尺寸能够就地进行可控制的膨胀，以便与心房附件的尺寸相符。而且，膨胀机构能够膨胀成至少部分翻转，从而使医生能够优化或调节该装置的就地展开。这里所述的各种植入装置都添加到在美国专利申请No.09/428008、美国专利申请No.09/614091、美国专利申请No.09/642291以及美国专利申请No.09/697628中所述的各种装置中，所有这些文献被本文参引。
图1a表示了处于紧凑尺寸的装置101，这时它适于通过心导管插入而传送给心房附件100(图1b)。装置101有隔膜管120，可膨胀构件130布置在该隔膜管120内。隔膜管120可以由薄的柔性材料制成。相反，膨胀构件130可以有由更硬的材料制成的部件，该更硬的材料例如硬塑料或包括形状记忆合金的耐腐蚀金属合金。膨胀构件130具有折叠形状(图1a)和较大的膨胀形状(图1b和1c)。
在折叠形状和膨胀形状中，构件130都可以为大致圆柱形形状。构件130可以设计成使它能够在轴向长度不同时发生明显变化的情况下进行径向膨胀。还设计成能够进行永久性变形，或者构件130在膨胀过程中部分或完全翻转变形。图1c示意表示了一个内部构件130实例在处于膨胀形状时的一部分。图1C中所示的构件130类似于在例如美国申请No.09/642291中所示和所述的构件。构件130包括相互连接的蛇形段131。相邻的蛇形段131通过大量纵向撑杆132而相互连接。端头的蛇形段131通过径向部件133与中心的空心圆柱环134相连。例如，一些或全部部件130-134可以由形状记忆金制成。
当构件130置于心房附件100中时，可以用外部起动装置来改变该构件130的形状。例如，气球140(例如通过中空圆柱形环134布置在构件130内)可以充气以便使构件130的形状从它的折叠形状转变成膨胀形状。通常，例如分别通过由合适的弹性密封开口例如阀结构142而向气球140本体注入合适流体或者从该气球140本体抽出合适流体气球140，从而可以使气球140充气或放气。该弹性密封开口例如阀结构142防止注入气球140的流体不受控制地释放。
例如，图1b表示了膨胀至合适的膨胀尺寸，以便在心房附件100内永久性展开的装置101。装置101可以用于过滤从心房附件100流出的血液。装置101有隔膜管120，膨胀构件130布置在该隔膜管120内。隔膜管120为大致圆柱形形状，且可以使它的远端和近端中的一个或者两个都封闭。图1b表示了远端和近端都是封闭端124的隔膜管120。该隔膜管120可以由可生物相容的材料制成，例如ePFTE(例如Gortex)、聚酯(例如Dacron)、PTFE(例如Teflon)、硅酮、尿烷、金属纤维或其它可生物相容的聚合物。
在装置101的一个实施例中，封闭端124的至少一部分作为过滤元件125，用于从血流中过滤出大小有危害的血栓。过滤元件125由血液可透过的材料制成。隔膜管125的其余部分(例如侧面126)可以由血液不可透过的材料制成。用于制造隔膜管125部件的材料可以是任意合适的可生物相容的材料，例如ePFTE(例如Gortex)、聚酯(例如Dacron)、PTFE(例如Teflon)、硅酮、尿烷、金属纤维或其它可生物相容的聚合物。用于制造过滤元件125的血液可透过材料的结构优选是两维筛网、蜂窝列阵、纺织网或无纺网等。血液可透过材料的结构还优选是可透过的金属或者细金属纤维的网。而且，在过滤元件125中的血液可透过材料可以涂覆或覆盖有抗凝血剂，例如肝磷脂或其它化合物，或者经过处理以使过滤元件125有抗血栓形成特性，从而防止过滤元件125被积累的血凝块堵塞。
过滤元件125有穿过它们的孔，以便血液流过。应当知道，在本文中，术语孔是指在过滤元件的结构中的开口，该开口提供了从该过滤元件的一侧到另一侧的连续开口槽道或通道。术语孔隙是指在过滤元件的材料中的小腔体。腔体或孔隙并不能提供穿过该过滤元件的连续开口槽道或通道。不过，局部开口的表面孔隙是表面组织的重要部分，它有利于细胞组织向内生长。
包含在过滤元件125中的血液可透过材料的孔的尺寸可以选择为足够小，这样，大小有危害的血栓可以从在附件100和心房105(图1b和1c中表示了一部分)之间流动的血液中滤出。该孔的尺寸还选择为足够大，以便提供充分的导流能力，从而使无血栓的血液通过该装置101。过滤元件125可以有直径大小范围为例如从大约50到大约400微米的孔。孔的大小例如可以考虑到各个情况而合适选择为并所述更大或更小，只要该孔足以防止大小有危害的血栓通过。
优选是，过滤元件125的开口面积为封闭端124的总表面积的至少20％，而优选的范围可以为大约25-60％。
上述用于制造过滤元件125的材料的孔的尺寸分布允许血液流过，同时阻挡或防止在心房附件中形成的血栓、血凝块或栓子通过并进入心脏的心房和最终进入病人的血流。
在可选实施例中，基本整个隔膜管120都可以由血液可透过的材料制成，该血液可透过材料适于过滤大小有危害的血栓。在隔膜管120中采用单种材料(或较少种的不同材料)可以简化它的制造。这时，用抗凝血剂涂覆或覆盖封闭端124部分就足以防止心房附件100和心房105之间的血流阻塞。例如，侧面126并不需要由抗凝血剂覆盖，因为当装置101在心房附件中展开时，该侧面126在任何情况下都可能被心房附件壁组织密封，如后面所述。
例如，对于上述的所有装置101实施例，当充分展开时，隔膜管120在心房附件100中保持就位，这样，近处的封闭端124跨过口110延伸或盖住该口110。当装置101首先插入心房附件100中之后，膨胀构件130例如通过向气球140充气而从它的初始紧凑尺寸膨胀到膨胀尺寸。膨胀构件130膨胀到合适尺寸，以便使隔膜管侧面126直接压靠心房附件100的内壁100a。由构件130的向外压而引起的、侧面126与内壁组织100a的直接啮合保持住装置101，并在一定程度上提供了阻碍装置101在心房附件100中运动的阻力，并将装置101保持在基本固定的位置。不过，至少在植入过程的初始阶段，该阻力可以反转，以便在需要或希望时能重新定位该装置101。该反转可以完全或部分与构件130的弹性变形特性相对应。例如，该反转可以通过气球140的放气而实现。以后，与侧面126的外表面组织相符的、内皮或心内组织的再生组织生长可以裹住该侧面126，并提供对完全展开的装置101的附加固定。该组织生长裹住例如可以包括组织向内生长到侧面126材料的局部开口的表面孔隙内，或者当该侧面126由具有孔的血液可透过材料制成时还包括组织向内生长到血液可透过材料的孔内。该组织生长与由内部构件130提供的向外压力一起，可以提供用于减小在装置101外周附近的流动泄漏的附加装置。
在某些植入过程中，可能希望将气球140留在原处，例如成放完气的状态。在其它植入过程中，可能希望在装置101已经固定在附件100中之后取出气球140。需要或希望时，可以利用普通的导管插入方法而将气球140从病人身体中取出。气球140可以通过在封闭端124中的合适自密封开口而从管120中取出。合适的自密封开口可以是由交叠的隔膜阀瓣(例如图1b的阀瓣124)。也可以采用其它类型的普通自密封开口，例如由弹性O形环构件(未示出)形成的自密封开口。
在装置101的还一实施例中，膨胀内部构件130可以是自膨胀构件。构件130可以有合适的偏压装置，例如弹簧或其它弹性部件，该偏压装置使得构件130的形状从它植入时的折叠形状转变成在装置101已经植入后的膨胀形状。自膨胀构件130也可以具有例如由形状记忆合金(例如Nitinol)制成的部件。该形状记忆合金部件可以预制成形状与构件130的膨胀形状相符。该预制的部件可以弯曲或压缩，以便形成处于折叠形状的构件130。当装置植入后，加热或改变温度使得弯曲或压缩的形状记忆合金部件自动回复到与构件130的膨胀形状相符的预制品形状。例如，图2表示了装置101，该装置通过自膨胀构件200膨胀到合适的膨胀尺寸，以便在心房附件100中永久性展开。
其它的植入装置实施例可以有其它类型的可充气或可膨胀构件，该可充气或可膨胀构件使得该装置能够有紧凑尺寸，以便进行装置传送，且该可充气或可膨胀构件随后能够就地扩大，以便使该装置的尺寸与心房附件的尺寸相符。这些实施例的植入装置可以有一个或多个组成构件或子构件。装置中的一个或多个组成构件或子构件可以进行膨胀或充气。第一类型的组成构件或子构件可以包括血液可透过的过滤元件，并用于例如将大小有危害的血栓从血流中滤出。第二类型的组成构件或子构件可以包括锚固元件，并用于例如将展开的装置保持就位。应当知道，在本发明中，并不是试图使部件类型必须有相互排斥的功能。且也不是将类型限制成只有过滤元件或只有锚固元件。单个组成构件可以既用于过滤血流，也用于将展开的装置保持就位。
有一个或多个这样类型的组成构件或子构件的不同装置实施例相应可以有不同的轴向长度，这些轴向长度覆盖很宽范围的值。在该范围的上端点处，装置的轴向长度可以与心房附件的长度的主要部分相当或相同。在该范围的底端点处，装置的轴向长度可以与口以及心房附件的、通向该口的颈部区域的长度的一部分相当或相同。
图3a、3b、3c和4中表示了一个装置实施例，该装置有较短的轴向长度，适于在口内完全展开。装置300有较薄的可膨胀或可充气构件310。图3a示意表示了在传送后的装置300，用于展开布置在口305内。构件310在膨胀后可以具有例如类似蘑菇帽(图3b)、药丸盒(图3c)、圆环形管的形状，或者为其它适于与口305啮合的形状。
可膨胀构件310可以由隔膜制成，或者由可生物相容的材料制成，例如ePFTE(例如Gortex)、聚酯(例如Dacron)、PTFE(例如Teflon)、硅酮、尿烷、金属纤维或其它可生物相容的聚合物。可膨胀构件310包括过滤元件，用于过滤大小有危害的血栓(未示出)。构件310可以包括不可膨胀的部分，该部分由适于过滤大小有危害的血栓(未示出)的血液可透过隔膜或织物制成。当构件310为可膨胀的圆环形状时，不可膨胀的部分可以跨过该圆环形状的中心区域延伸。构件310还可以包括进入开口或固定件，以便安装导管或其它传送装置(未示出)。锚固件330安装在可膨胀构件310的外周上。该锚固件330例如可以安装在可膨胀构件310的后部附近的出口缘上。锚固件330可以是销钉、钩子、倒钩、有防止损伤的球形顶端的金属线或者其它用于与组织啮合的合适结构。当锚固件330与周围的口壁组织啮合时，装置300相对于口305固定就位。
装置300可以合适展开，以便通过使可膨胀构件310跨过口305延伸来过滤流过口305的血液。可膨胀构件310可以进行自膨胀(例如象图2的构件130)。也可选择，可膨胀构件310可以包括用于膨胀的外部起动机械装置(例如象图1b的气球140)。图4示意表示了当可膨胀构件310进行充气时装置300的尺寸增大。图4表示了装置300从初始尺寸a增加到中间尺寸b，再增加到尺寸c。当装置300的尺寸增加时，附加的锚固件330朝着口305的内壁径向向外运动。当构件310充分膨胀时，锚固件330与周围的内壁组织啮合，并使装置300固定就位。
图5a表示了植入装置500，该植入装置500的轴向长度与心房附件100的长度的主要部分相当。装置500有两个组成构件，即近端构件510和远端构件520。近端构件510可以用于盖住心房附件100的口110，该近端构件510包括血液可透过的过滤元件，该过滤元件过滤流过口110的血液。近端构件510可以由合适织物制成，该织物由可生物相容的材料制成，例如ePFTE(例如Gortex)、聚酯(例如Dacron)、PTFE(例如Teflon)、硅酮、尿烷、金属纤维或其它可生物相容的聚合物。近端构件510可以是可膨胀构件，它例如可以与上面参考图3a、3b和3c所述的可膨胀构件310类似。也可选择，近端构件510可以是不可膨胀或不可充气的构件。不可充气的构件510例如可以是在美国专利申请No.09/428008、美国专利申请No.09/614091、美国专利申请No.09/642291以及美国专利申请No.09/697628中所述的、用于盖住口110的任意一种构件，这些文献都被本文参引。
在各种情况下，构件510通过利用附加的远端构件520而跨过口110保持就位。远端构件520是可充气的，并有安装在轴向部分或杆521上的一个或多个锚固装置530。各锚固装置530有合适数目的可膨胀锚固件531，该锚固件531设计成与心房附件100的内壁啮合。在装置530中的可膨胀锚固件531可以在离近端盖体510(未示出)合适距离处沿径向外周而安装在轴向部分521上。也可选择，在装置530中的可膨胀锚固件531可以沿一定轴向长度而安装在轴向部分521上，例如如图5a所示。也可以采用其它的锚固件531分布形式。例如，锚固件531可以沿螺旋形安装在轴向部分521上。包括锚固装置530的远端构件520可以由合适织物制成，该织物由可生物相容的材料制成，例如ePFTE(例如Gortex)、聚酯(例如Dacron)、PTFE(例如Teflon)、硅酮、尿烷、金属纤维或其它可生物相容的聚合物。
当远端构件520放气，且近端构件510根据它是可膨胀构件还是不可膨胀构件而进行放气或合适折叠时，装置500处于紧凑尺寸，适于进行皮内传送。在植入过程中，处于紧凑尺寸的装置500例如可以通过心导管插入法而传送给心房附件100。当完全展开时，装置500布置成使近端构件510大致跨过口510延伸。远端构件520布置在心房附件100的内部。远端构件520通过合适装置进行充气，这样，充气的锚固件531与心房附件100的内壁啮合，并压靠该内壁。在向外挤压的锚固件531和心房附件壁之间的摩擦将装置500保持在它完全展开的合适位置。用于使构件520充气的合适方法例如可以包括通过合适开口(未示出)而将流体注入构件520中。该开口可以有合适的阀密封件，从而防止充入的流体不受控制地释放或泄漏。
在另一装置实施例中，单个可膨胀构件可以提供上述远端构件和近端构件的功能。这样的装置可以有足够短的轴向长度，这样，整个装置或几乎整个装置都可以安装在心房附件的口或口区域中。装置的前面部分可以用于盖住该口，以便引导心房附件和心房之间的血流通过过滤元件。附加的锚固件可以布置在装置的后面部分的外表面区域的至少一部分上。该锚固件可以是销钉、钩子、倒钩、有防止损伤的球形顶端的金属线或者其它用于与组织啮合的合适结构。该单个可膨胀构件可以自膨胀，或者可以通过外部起动装置而膨胀。当装置膨胀时，安装在它的后面部分上的锚固件与口的后壁啮合和/或可能时与心房附件的、靠近该口的颈部区域的内表面啮合。该装置可以利用合适的隔膜或由可生物相容的材料制成的织物而制成，该可生物相容的材料例如前面所述的材料。而且，该可生物相容的材料例如可以有前面所述的任意结构(例如蜂窝列阵、线网等)。
在图5b和5c中表示了一个植入装置实例550，该装置的大部分或几乎全部都装入心房附件的口内。这两个图分别表示了装置550的侧视图和俯视图。象装置300(图3a)一样，装置550具有单组成构件，即可膨胀构件551。可膨胀构件551包括前面部分560和后面部分570。装置550的轴向长度可以与口的长度相当或稍微大于该口的长度。轴向长度稍微大于口的长度的装置550在展开时可以延伸到心房附件的、靠近口的颈部区域内。
图5b表示了处于膨胀尺寸的装置550，这时它可以在口中展开。前面部分560可以由弹性隔膜制成，并包括合适的过滤元件565，用于将大小用危害的血栓从血流中滤出。前面部分560可以包括合适的开口或固定件，以便安装导管或其它传送装置(未示出)。前面部分560用于盖住该口，以保证流过该口的全部血液都经过过滤元件565。前面部分570例如可以由线网(如图所示)、编织物或纺织物、或者板材管的较短段而形成。后面部分570可以有与口的尺寸相符的径向尺寸。例如，图5c表示了圆柱形的后面部分570，该后面部分570沿其轴向方向有基本恒定尺寸的横截面。也可选择，圆柱形的后面部分570可以为锥形，它的直径沿它的轴向长度增加，以便与口的直径变化相匹配，例如，当口并入心房附件(未示出)的颈部区域中时。
如图5b所示，后面部分570有倒钩575，该倒钩575分布在靠近前面部分560的外表面区域的一部分上。也可选择，倒钩575可以分布在全部外表面区域上。当装置550布置在口内并膨胀时，倒钩575与周围的口壁啮合(可能时还与颈部区域壁啮合)，以便将装置550固定就位。
后面部分570可以选择有合适的弹性变形特性，这使得该部分570的尺寸能够从它的最大膨胀尺寸稍微弹回。该合适的变形特性可以通过设计获得，例如通过选择具有合适弹性特性的制造材料。装置550的尺寸弹回使得已经在装置550的膨胀过程中与口和/或颈部区域的壁啮合的倒钩575将壁往回拉，并使该壁更靠近装置550。在包括前面所述实施例(例如图1-4，图5a)的其它装置实施例中，可膨胀构件也可以有类似的尺寸弹回弹性，这使得附加的锚固件与周围的壁组织啮合，并拉动该壁组织，使它们更靠近装置。
各种可膨胀植入装置(例如上面参考图1-5所述的可膨胀植入装置)可以有过滤元件，用于将大小有危害的血栓从流出心房附件并流入心房的血液中滤出。为了有效过滤，过滤元件将有合适的孔尺寸分布，该孔将滤出大小用危害的血栓。因为植入装置例如可以在使用时膨胀至不同尺寸，以便与各个心房附件的不同尺寸相符，因此，该过滤元件设置成使它们的孔尺寸分布在装置的膨胀过程中不会有很大变化。
例如，图6表示了过滤元件600的一种结构，其中，在装置的展开过程中，孔610的尺寸分布不会有很大的变化。在所示结构中，过滤元件600安装在弹性隔膜620上。过滤元件600和弹性隔膜620例如可以由包括可生物相容材料的合适隔膜或织物制成，该可生物相容的材料例如ePFTE(例如Gortex)、聚酯(例如Dacron)、PTFE(例如Teflon)、硅酮、尿烷、金属纤维或其它可生物相容的聚合物。过滤器600的孔的直径尺寸可以从大约50至大约400微米，以便适于过滤大小用危害的血栓。该范围的孔尺寸分布足以使得过滤元件600阻止大小用危害的血栓透过，还对于流过该元件600的血液有足够的可透过性。孔的尺寸分布例如可以通过选择用于制造过滤器600的织物的网眼密度而进行选择。也可选择，例如对于由实心板材制成的过滤元件，也可以采用其它方法例如激光钻孔，以便形成小直径的孔。
过滤元件600和弹性隔膜620设置成使前者的弹性远远小于后者。例如可以通过采用同种材料来制造两个部件，但使得过滤元件600远远厚于弹性隔膜620，从而获得该不同弹性。也可选择，弹性隔膜620和过滤器600由具有不同弹性特性的两种不同材料制成。这两种不同材料的部件可以粘接或胶接在一起。
过滤元件600和弹性隔膜620可以包含在各种类型的植入装置构件中，例如图1a的隔膜管120、图3a的可膨胀构件310、图5a的近端构件510元件图5b的前面部分560。当包含这两个部件的装置膨胀时，由于装置尺寸增大而伴随发生的过滤器结构的拉伸大部分通过弹性隔膜620的拉伸来承受，从而使过滤元件600的尺寸基本与它的预定值相同。
应当知道，前面所述只是举例说明了本发明的原理，在不脱离本发明的范围和精神的情况下，本领域技术人员可以进行各种变化。应当知道，象“远端”和“近端”、“前面”和“后面”这样的术语以及其它方向或方位术语只是为了方便而使用，这些术语并没有固定或绝对的方位。

Claims (49)

1.一种用于过滤流过心房附件口的血液的装置，包括：
隔膜管，该隔膜管有至少第一封闭端，其中，所述第一封闭端包括血液可透过的过滤器；以及
可膨胀的构件，该可膨胀构件布置在所述管内，所述构件有折叠形状和膨胀形状，
其中，当所述可膨胀构件处于所述折叠形状时，所述装置可插入所述附件内，当所述可膨胀构件处于所述膨胀形状时，所述封闭端盖住所述心房附件口，且所述隔膜管的一部分向外压靠所述心房附件的内壁，从而将所述装置锚固在所述心房附件内。
2.根据权利要求1所述的装置，其中：所述隔膜管为基本圆柱形形状。
3.根据权利要求1所述的装置，其中：所述隔膜管有第二封闭端。
4.根据权利要求3所述的装置，其中：所述第二封闭端包括血液可透过的过滤器。
5.根据权利要求1所述的装置，其中：所述可膨胀构件为自膨胀。
6.根据权利要求1所述的装置，其中：所述可膨胀构件通过可充气的气球而从所述折叠形状膨胀到所述膨胀形状。
7.根据权利要求6所述的装置，其中：所述第一封闭端还包括自密封开口，用于取出所述可充气的气球。
8.根据权利要求7所述的装置，其中：所述自密封开口包括弹性环。
9.根据权利要求7所述的装置，其中：所述自密封开口包括交叠的隔膜阀瓣。
10.根据权利要求1所述的装置，其中：所述隔膜管包括弹性材料。
11.根据权利要求1所述的装置，其中：所述隔膜管包括编织材料。
12.根据权利要求1所述的装置，其中：所述隔膜管包括纺织材料。
13.一种用于过滤流过心房附件口的血液的方法，包括：
提供包括隔膜管的装置，该隔膜管有至少第一封闭端，其中，所述第一封闭端包括血液可透过的过滤器；
将所述装置插入所述附件内；
将所述封闭端定位成盖住所述口；以及
将所述装置锚固在所述心房附件内。
14.根据权利要求13所述的方法，其中：所述锚固包括将所述管的侧面向外压靠在所述心房附件的内壁上。
15.根据权利要求13所述的方法，其中：所述提供装置还包括将可膨胀构件布置在所述隔膜管内，其中，所述插入还包括当所述可膨胀构件处于折叠形状时将所述装置置于所述心房附件中，且所述定位和所述锚固包括使所述可膨胀构件膨胀至膨胀形状。
16.根据权利要求15所述的方法，其中：所述膨胀包括使用可充气的气球。
17.根据权利要求16所述的方法，还包括：当所述装置锚固在所述心房附件中之后，使所述气球放气并将所述气球从所述心房附件中取出。
18.一种用于过滤流过心房附件口的血液的装置，包括：
盖体，该盖体包括：
过滤元件，该过滤元件有预定尺寸；以及
可膨胀隔膜，该可膨胀隔膜安装在所述过滤元件上；以及
可膨胀构件，用于展开所述盖体，
其中，所述可膨胀隔膜在所述盖体展开时拉伸，并使得所述预定尺寸保持基本不变。
19.根据权利要求18所述的装置，其中：所述过滤元件包括孔，该孔使得尺寸有危害的血栓基本不能透过。
20.根据权利要求18所述的装置，其中：所述过滤元件由弹性小于所述可膨胀隔膜的材料制成。
21.一种用于过滤流过心房附件口的血液的方法，包括：
提供盖体，该盖体包括可膨胀隔膜，该可膨胀隔膜安装在具有预定尺寸的过滤元件上；
提供可膨胀构件，用于跨过所述口来展开所述盖体；
利用所述可膨胀构件来将所述盖体定位成跨过所述口；
其中，所述定位包括拉伸所述可膨胀隔膜，从而使得所述预定尺寸基本不变。
22.一种用于过滤流过心房附件口的血液的装置，包括：
可膨胀的构件，用于盖住所述口；以及
锚固件，该锚固件布置在所述可膨胀构件的外周上，其中，可膨胀构件的轴向长度小于所述口和通向所述口的所述心房附件的颈部区域的近似组合长度，其中，所述可膨胀构件包括血液可透过的过滤器，其中，所述锚固件与周围的口壁组织啮合。
23.根据权利要求22所述的装置，其中：所述可膨胀构件为自膨胀。
24.根据权利要求22所述的装置，其中：所述可膨胀构件通过外部起动装置而膨胀。
25.根据权利要求24所述的装置，其中：所述外部起动装置包括可充气的气球。
26.根据权利要求22所述的装置，其中：所述血液可透过的过滤器包括孔，该孔使得尺寸有危害的血栓基本不能透过。
27.一种用于过滤流过心房附件口的血液的方法，包括：
提供可膨胀的构件，该可膨胀构件包括血液可透过的过滤器，所述可膨胀构件的轴向长度小于口的近似长度；
提供锚固件，该锚固件安装在所述可膨胀构件上；
将所述可膨胀构件布置在所述口内；
将所述可膨胀构件定位成盖住所述口；以及
使所述可膨胀构件膨胀，从而使所述锚固件与周围的口壁组织啮合。
28.根据权利要求27所述的方法，其中：所述提供可膨胀构件包括提供自膨胀构件。
29.根据权利要求27所述的方法，其中：所述提供可膨胀构件还包括提供外部起动装置，以便使所述可膨胀构件膨胀，其中，所述膨胀包括起动所述装置。
30.根据权利要求29所述的方法，其中：所述提供外部起动装置包括提供可充气的气球，其中，所述起动包括使所述可充气的气球充气。
31.根据权利要求30所述的方法，还包括：在所述锚固件与周围的口壁组织啮合之后，使所述可充气的气球放气，并取出该气球。
32.根据权利要求27所述的方法，其中：将所述可膨胀构件定位成盖住所述口包括定位所述可膨胀构件，以便引导流过所述口的基本全部血液都通过所述过滤器。
33.一种用于过滤流过心房附件口的血液的装置，包括：
第一构件，该第一构件包括血液可透过的过滤元件；以及
第二构件，该第二构件安装在所述第一构件上，所述后面的构件包括至少一个可充气的锚固装置，
其中，所述第一构件跨过所述口展开，所述可充气的锚固装置在充气时与所述心房附件的内壁组织啮合，以便将所述装置固定在它的展开位置。
34.根据权利要求33所述的装置，其中：所述第二构件包括轴向部分，所述至少一个可充气的锚固装置包括沿所述轴向部分的径向外周而安装在所述轴向部分上的锚固件。
35.根据权利要求33所述的装置，其中：所述第二构件包括轴向部分，所述至少一个可充气的锚固装置包括沿所述轴向部分的轴向长度而安装在所述轴向部分上的锚固件。
36.根据权利要求33所述的装置，其中：所述第一构件包括可充气的构件。
37.根据权利要求33所述的装置，其中：所述过滤元件包括孔，该孔使尺寸用危害的血栓基本不能透过。
38.一种用于过滤流过心房附件口的血液的方法，包括：
提供一种装置，该装置包括：
第一构件，该第一构件包括血液可透过的过滤元件；以及
第二构件，该第二构件安装在所述第一构件上，所述第二构件包括至少一个可充气的锚固装置，
将所述第一构件定位成盖住所述口；
将所述第二构件布置在所述心房附件的内部；以及
使所述锚固装置充气膨胀，从而使所述锚固件与周围的心房附件壁组织啮合。
39.根据权利要求38所述的方法，其中：提供植入装置还包括提供包括可充气构件的所述第一构件。
40.一种用于过滤流过心房附件口的血液的装置，包括：
可膨胀构件，包括：
第一部分，该第一部分有血液可透过的过滤元件；以及
第二部分，该第二部分为圆柱形形状；以及
锚固件，该锚固件布置在所述第二部分的外表面的至少一部分上，
其中，当通过使所述可膨胀构件膨胀而使所述装置在所述口附近展开时，所述第一部分盖住所述口，以便引导血液流过所述过滤元件，且所述锚固件与周围的壁组织啮合。
41.根据权利要求40所述的装置，其中：所述过滤元件包括孔，该孔使得大小有危害的血栓基本不能透过。
42.根据权利要求40所述的装置，其中：所述第二部分还包括基本恒定直径的圆柱形构件。
43.根据权利要求40所述的装置，其中：所述第二部分还包括扩大直径的圆柱形构件。
44.根据权利要求40所述的装置，其中：所述可膨胀构件为自膨胀。
45.根据权利要求40所述的装置，其中：所述可膨胀构件为可膨胀的气球。
46.根据权利要求40所述的装置，其中：所述可膨胀构件具有弹性变形特性，使得所述可膨胀构件的尺寸能从它的膨胀尺寸弹回。
47.根据权利要求46所述的装置，其中：所述尺寸弹回使得已经与周围的壁组织啮合的所述锚固件将所述壁往回拉，并使该壁更靠近所述装置。
48.一种用于过滤流过心房附件口的血液的方法，包括：
提供一种装置，该装置包括：
可膨胀构件，所述可膨胀构件包括：
第一部分，该第一部分有血液可透过的过滤元件；以及
第二部分，该第二部分为圆柱形形状；以及
锚固件，该锚固件布置在所述第二部分的外表面的至少一部分上，
使所述装置在所述口附近展开，其中，所述展开包括：
将所述第一部分定位成盖住所述口；以及
使所述可膨胀构件膨胀，从而使所述锚固件与周围的壁组织啮合。
49.根据权利要求48所述的装置，其中：提供装置还包括提供尺寸可从它的膨胀尺寸弹回的所述可膨胀构件，且所述膨胀还包括使所述可膨胀构件膨胀和弹回，从而使所述锚固件与周围的壁组织啮合，并将所述壁朝着装置往回拉。
CN01814305A 2000-08-18 2001-08-17 用于过滤从心房附件流出的血液的可膨胀植入装置 Pending CN1447669A (zh)

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US10278805B2 (en) 2019-05-07
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US20140107696A1 (en) 2014-04-17
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US20160008122A1 (en) 2016-01-14
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US9161830B2 (en) 2015-10-20
US8197527B2 (en) 2012-06-12

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