CN1529571A - 心房过滤器植入物 - Google Patents
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Abstract
用于过滤流经心房附件口的血液的植入物装置,具有弹性盖和锚固子结构。所述子结构包括可逆地折叠的叉或可压缩的丝编结构。所述装置折叠装配在导管中,以便输送到心房附件中。当所述装置从导管排出时,它们弹性地扩展到其原始尺寸。所述盖上的过滤元件阻止血栓经所述口流出。具有叉式子结构的所述装置可具有H形的截面。这些装置通过夹紧所述盖和所述锚固子结构之间的口组织的环形区域而密封所述附件。对于不同长度的心房附件,这些H形的装置的浅展开深度可以通用的装置尺寸得以使用。所述装置可包括远程致动的固定件,用于重新折叠所述叉,以便装置回收和位置调节。
Description
本发明要求享有2001年3月8日提交的美国临时申请No.60/274345和60/274344、2001年3月8日提交的美国临时申请No.60/274189,和2001年5月1日提交的美国临时申请No.60/287829的权利,在此通过引用而包含其全部内容。
发明背景
本发明涉及一种植入物装置,该装置可以植入到心房附件中,用于过滤在心房附件和心脏的相关腔室之间流动的血液,防止血栓从心房附件中逸出而进入身体的血液循环系统。
多种心脏病(例如,冠状动脉疾病,二尖瓣疾病)对于患者的心脏有各种不利的影响。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。心房纤颤导致心输出量降低。血栓栓塞(例如血栓颗粒)的高发现象与心房纤颤有关,左心房附件(LAA)经常是栓塞(颗粒)源。
在LAA中,血栓(例如血凝块)的形成可能是由于纤颤中的郁积和未充分排空LAA造成的。汇流到心房附件中的血液有助于形成血凝块。血凝块可能累积,并在其自身基础上增加。小或大的血凝块碎片会破碎,然后从心房附件扩散到心房中。然后,血凝块碎片可进入人体的血液循环,并在血流末梢发生血栓。
从心房附件进入身体血流中的血凝块碎片会产生严重的医学问题。血液从左心房和左心室循环进入心肌、大脑、以及其他身体器官,为它们供应必须的氧气和其它营养。由在左心房附件中形成的血凝块产生的血栓会阻塞心房,其中血液经该心房流到身体器官。这种阻塞使器官组织失去了正常的血流和氧气供应(局部缺血),且根据涉及的身体器官,导致局部缺血现象,比如心脏病(心肌局部缺血)和中风(脑组织局部缺血)。
因此,寻求一种避免左心房附件中形成血凝块的方法非常重要。而且,寻求一种避免由左心房附件中形成的任何血凝块产生的碎片和血栓经血流扩散到心肌、脑和其他身体器官中的装置也非常重要。
美国专利US5865791(在下文中,称为’791专利)涉及减少心脏中的血瘀区域,以及最终减少该区域的血栓形成,尤其是在有心房纤颤的病人的心房附件内。更准确地说,’791专利中涉及按照避免随后形成血栓的方位固定心房附件的方法和装置。在’791专利中,通过拉起附件而从心房中取出所述附件,并在所述附件周围放置一环,从而形成附件袋,然后将其从心脏的其余部分上切下。
美国专利US5306234描述了一种通过手术封闭心房和心房附件之间的通道,或割断心房附件的方法。
最近提出的某些治疗方法针对的是在心房附件中植入插入式装置,以阻塞血液的流动。
用于避免血栓现象(例如,心脏病、中风和其他局部缺血现象)的一种预防治疗方法包括将有害的血栓从心房附件中过滤掉。均未审结和共有的美国专利申请No.09/428008,美国专利申请No.09/614091,美国专利申请No.09/642291,美国专利申请No.09/932512,描述了可以植入心房附件中而过滤血流的过滤装置,在此通过引用而包含其全部内容。所述装置可以利用普通的心脏导管插入方法送入心房附件中。这些方法可包括经中隔的导管插入术,该手术包括刺穿心房隔膜。
较大的导管和植入物装置可能需要在隔膜上有较大穿孔。在输送或植入过程中,较大的导管和装置可能损伤身体组织。对身体组织的损伤可能导致外伤,增加恢复时间,增加并发症的危险,并增加病人护理的花费。而且,在病人与病人之间心房附件可能形状和大小不同。
美国专利申请No.09/932512公开了较小的植入物装置,该装置可以通过小尺寸的导管送入心房附件中。在成功的装置植入过程中,要素是植入的装置在心房附件中可靠地保持。植入物装置的尺寸可以就地调节,例如与用于装置保持的个体心房附件的尺寸一致。
现在考虑其他的植入物装置设计,以提供更多不同的装置,从而可以选择适当的装置,匹配个体的心房附件。
发明内容
本发明提供了植入物装置和方法,该装置可用于过滤流经心房附件和心房室之间的血液。所述装置设计用于防止心房附件内形成的血液凝块释放入身体的血液循环系统。
在此公开的所有装置都具有弹性结构。所述弹性结构可以使所述装置折叠或压缩,以使尺寸紧凑,而可以装在例如通过导管插入术输送的窄径管中。当从输送导管中排出时,所述压缩的装置弹性扩展至其实际尺寸。所述装置的形状可以使展开的装置在其展开时所处的心房附件中保持位置。所述装置包括适当的从流经心房附件的血液中过滤血栓的过滤元件。
所述装置可包括回收管,该管使展开或扩展的装置重新压缩。使用内部导管轴或丝可以远程启动所述回收管。被重新压缩的装置可以退回输送导管中,以便装置回收和位置调节。
一个实施例的植入物装置具有可扩展的近端盖和远端锚固子结构。所述可扩展的子结构包括折叠叉。所述叉可以由弹性材料制成,例如弹性的形状记忆合金。所述叉可以沿所述装置的轴线向下折叠,而使所述装置压缩,便于导管输送。在扩展的装置中,所述叉从使所述装置具有H形横截面的装置中部径向向外延伸。
所述近端盖包括血液渗透型过滤元件。所述血液过滤元件用于防止有害尺寸的血栓通过。当装置在心房附件中展开时,近端盖的叉啮合包围附件口的心房壁部分,而密封所述附件。所述锚固叉啮合心房附件的壁组织。所述锚固叉的形状可以使其在口壁组织的环形区域上施加向外的弹性压力。包围所述口的心房壁部分与所述近端叉的啮合,以及心房附件壁组织与锚固叉的同时啮合相联合,夹紧近端盖和锚固子结构之间的口壁组织的环形区域。口壁组织的这种夹紧可以有效地密封心房附件,且引导血液流经近端血液渗透型的过滤元件。
这些装置的H形横截面使装置在紧接心房附件口附近完全展开。所以,普通大小的装置可以是适于长度和深度不同的心房附件的植入物。
在本发明的植入物装置的另一实施例中,一个弹性结构可用于过滤血流,并在适当位置锚固展开的装置。通常圆柱形形状的弹性结构是由丝编材料制成的。使用普通的丝材,比如不锈钢或镍钛合金(nitinol)制成所述丝编织物。所述装置结构的远端部分啮合心房附件的壁组织,使植入物装置保持位置。所述圆柱形装置结构的近端封闭,且设计用于沿心房附件延伸。在封闭的圆柱形近端上的过滤膜防止有害尺寸的血栓从心房附件流出。所述过滤膜例如是由聚酯纤维制成的。或者,细丝或纤维可以与近端的所述装置的丝编织物交织,而形成具有较小的丝间孔尺寸的高密度编织物。所述孔的尺寸可以足够小,使高密度的编织物过滤有害尺寸的血栓。在某些装置中,整个装置的包括近端和远端的丝编结构可以由高密度的丝编材料制成。
从附图和下面的详细描述,本发明的其他特征,其性质和各优点将更为明显。
附图简要说明
图1a是根据本发明原理的H型植入物的支撑框架的透视图。
图1b是可以用于根据本发明原理的H型植入物的另一种支撑框架的透视图。
图1c是图1b的H型植入物的透视图,其中过滤元件放置在根据本发明原理的支撑框架上。
图2示出了根据本发明原理在心房附件中展开的如图1c所示的H型植入物的截面图。
图3是根据本发明原理的另一种植入物装置的透视图。
图4示出了图3所示的植入物装置放置在根据本发明的原理的心房附件的截面图。
图5是根据本发明原理的另一种植入物装置的示意图。其中所述装置示为处于折叠状态,且装在回收固定件中。
图6是当如图5所示的装置连接于根据本发明原理的输送系统时,处于扩展状态的所述装置的透视图。其中示出了部分输送系统。
图7是如图6所示的所述装置和输送系统的局部剖面透视图。
图8a是根据本发明原理的端部开口的丝编植入物装置的示意图。其中还示出了与所述装置连接的输送设备的一部分。
图8b是示出了在心房附件中展开的8a的装置的局部剖面示意图。
图9是根据本发明原理的另一两端封闭的丝编植入物装置的示意图。其中还示出了与所述装置连接的输送设备的一部分。
图10a是根据本发明原理的另一两端封闭的丝编植入物装置的示意图。
图10b是在心房附件中(剖面图)展开的图10a的装置示意图。其中还示出了与所述装置连接的图9的输送设备的一部分。
图11a是根据本发明原理的具有明显不同的近端盖的丝编植入物装置的示意图。
图11b是在心房附件(剖面图)中展开的图11a的装置示意图。
优选实施例的详细描述
尽管心房纤颤会引发血液向左心房附件中汇流,并且本发明主要是用于左心房附件,但本发明还可以用于右心房附件,并且一般可以放置在身体血液可以流入流出的任何体腔内。本发明旨在防止在任一心房或其他体腔内形成的血凝块通过所述附件口或体腔开口进入血流。
本发明的所述装置具有弹性结构。所述弹性结构可以折叠或压缩到非常紧凑的尺寸,而可以装入直径很小的导管中。这种导管可用于从经由皮肤的装置输送到所述心房附件中。传统的导管插入技术可用于装置的输送。所述装置输送到体内的适当位置,以便在心房附件中展开。当所述装置从输送导管排出,不再受输送导管的限制时,所述压缩的装置扩展至其实际大小。所述装置的形状可以使展开的装置在其展开时所处的心房附件中保持位置。所述装置包括适当的从流经心房附件的血液中过滤血栓的过滤元件。所述装置这样设计,即当展开时,所述过滤元件居中且跨过所述心房附件口定位时,适当地拦截并过滤流出心房附件的血流。所述装置的这种设计还可以使回收或重新调节展开的装置成为可能。
在此公开的植入物装置将增加美国专利申请No.09/428008,美国专利申请No.09/614091,美国专利申请No.09/642291,美国专利申请No.09/697628以及美国专利申请No.09/932512中公开的装置种类,在此通过引用而包含其全部内容。
图1a,1b和1c示出了装置100的示例性结构,它具有H型的截面。图2以截面图的形式示出了展开且过滤来自心房附件200的血流的H型装置。装置100可以具有支撑框架,例如,框架105或106。所述装置的框架可以具有一个或多个子结构,例如,近端盖子结构110和末端锚固子结构120。这两部分分别包括多个弹性肋或叉110a和120a。所述两部分在结构上通过装置中部130连接。叉110a和120a通常从中部130径向向外延伸,因此使装置100具有H型截面。叉110a和120a可以沿中部130的轴线150折叠,而使装置100具有紧凑的管状尺寸,因此可以装在输送导管中。
近端盖110包括血液渗透型过滤元件140,例如可以是环形或碟形的过滤膜(图1c)。当装置100展开时(图2),近端盖110跨过口230放置,拦截流经的血液。近端盖110圆周上的端部与围绕口230的心房壁部分啮合,密封心房附件200。末端锚固子结构123啮合靠近口230的心房附件壁组织,固定处于展开状态的装置100。口230的组织可以在近端盖110和末端锚固子结构120之间夹紧。夹紧在其周围的口230的组织,可以有效地密封心房附件200,且防止未过滤的血液渗漏到近端盖110的周围。
过滤元件140可以在使用生物兼容性材料制成,例如,含氟聚合物、比如ePFTE(例如,Gortex)或PTFE(例如,Teflon)、聚酯(例如,Dacron)、尿烷、硅酮、金属纤维,以及其他适当的生物兼容性材料。在过滤元件140的材料上设有导流孔,使过滤元件140可以透过血液。如本文所使用的,可以理解术语孔指的是形成从过滤元件的一侧到达另一侧的连续开放通道或通路的开口。过滤元件140上的孔的尺寸,可以选择得足够小,而使有害尺寸的血栓可以从流经附件200和心房210(在图2中部分示出)之间血液中过滤出。而且,孔的尺寸也可以选择得足够大,以形成足够的导流能力,让没有血栓的血液通过装置100。孔的尺寸可以介于例如直径50~400微米之间。孔的尺寸分布也可以适当选择,例如考虑到各自的情况,只要这种孔能基本上阻止有害尺寸的血栓通过,可以比所示的更大或者更小。过滤元件140的开口面积最好至少为整个表面积的20%,可取的是25~60%。
如上所述,过滤元件上孔的尺寸分布可以允许血液流过,同时阻碍或阻止在心房附件中形成的血栓块、血凝块和血栓进入心脏的心房,最终进入到病人的血流中。
参照图1a,1b,1c,近端盖110处的过滤元件140支撑在弹性肋或叉110a上。叉110a可以用任何适当的弹性材料制成,包括金属和聚合物材料。叉110a和120a可以例如用已知的形状记忆合金材料制成(例如,镍钛合金)。普通制造工艺可用于制造叉110a和120a。在一种这样的装置制造工艺中,激光铣削或切削可用于由镍钛合金管加工成实心预制件。在镍钛合金管的圆柱形部分的壁上切出纵向槽。这些槽从圆柱形部分的两端向内延伸适当的长度。相邻槽间的材料带形成近端盖和锚固子结构(例如,叉110a和120a)。镍钛合金管的非切割的中心部分可以在结构上连接两组叉。然后,所述预制件继续加工或成形为装置结构(例如,结构105或106)。叉110a和120a可以例如分别从未切割的中心部分相对端向上抬起。被抬起的叉径向向外张开,形成所述近端盖和锚固子结构,其直径可以远远大于初始的镍钛合金管直径。
选择所述锚固子结构的直径,当装置100装入心房附件中时,可以形成干涉配合。锚固叉120a可以为适当的形状或弯曲,而与所述心房附件壁形成无损伤接触,且可以在心房附件壁上施加向外的弹性压力,将装置100固定或保持在适当的位置。图1a示出例如弯曲的叉120带有圆形的叉边缘,而使其成为无损伤的。可选的是或另外,叉120a可以覆盖有软性材料覆盖物和/或设有无损伤的泡状或球形末端(例如,图5、6和7的装置500)。可选的是,所述锚固叉120a可以进一步弯曲,形成接触表面120s,所述表面通常平行于所述装置100的轴线150。图1b示出例如带有接触表面120s的叉120a通常平行于装置100的轴线150。当装置100展开时,叉子120a的平坦侧面(即,图1b和1c的接触表面120s)与心房附件壁形成无损伤的接触。
如前所述,叉110a通常从中部130径向向外延伸。延伸的叉110a的端部也可以朝末端子结构120(在图1b和1c中向下)翻转或弯曲,而使近端盖110具有通常朝末端子结构120下凹的形状。弹性叉110a的这种向下弯曲可以偏压叉110a,使近端盖110的圆周区域压在包围所述口的心房壁组织的环形区域上,其中装置100在所述口中展开。同样,形成锚固子结构120的径向延伸的叉120a可以朝近端盖110翻转或弯曲(在图1b和1c中向上)。弹性叉120a的这种向上弯曲可以偏压叉120a,朝近端盖110对包围所述口(装置100在所述口中展开)的心房附件壁组织加压。
当装置100在心房附件中展开时,弹性叉110a和120a的这种互相偏压有助于夹紧近端盖110和锚固子结构120之间的口壁组织的环形区域。叉110a和120a之间的间隔(在图1a和2中以间距“X”表示)可以适当地选择而足够小,以便封闭或夹紧口壁组织,有效地密封心房附件。相对于心房附件的尺寸,适当选择的间距X可以较小。叉110a和120a之间的小间距X对应于具有较小轴向长度的H形装置100。
H形状和较小的轴向长度使装置,比如装置100,在紧接心房附件口的附近彻底展开和固定。因为本发明的H形装置(例如装置100)的锚固子结构不伸入心房附件中,所以这种装置的使用有利地避免了装置的尺寸各不相同,否则需要调整尺寸以匹配病人心房附件的尺寸或形状。一个(或多个)通用的装置尺寸可以用于不同尺寸和形状的心房附件。
在图3中示出了另一种可以用于本发明的装置中的锚固叉。装置300的锚固子结构120具有叉320a,该叉通常指向装置300的近端。叉320可以与中部130的轴线150(朝近端盖110延伸)形成锐角“A”,如图3所示。这样,锚固子结构120的横截面大致为V形(或箭形),其中顶点在装置300的远端。叉320的这种结构可以在心房附件壁组织上产生钩子或鱼叉式的作用,防止装置300从已经在其中展开的心房附件排出。图4示出了例如在心房附件400中展开的装置300。叉110a将近端盖110弹性地压在包围所述附件口的心房壁上,密封附件400。叉320a的尖端啮合内壁。叉320a的V形截面指向附件400的后部。装置300的任何向前移动,都易于使接触壁的叉320a向后(较宽部分)弯曲。由于叉320a的特定结构,这种向后弯曲遇到弹性阻力,其中所述叉在结构上连接于中部130的末端。由于附件壁与叉320的钩式啮合,任何向前移动都遇到阻力。
装置300可以以类似于上述的方式制造,例如激光切割镍钛合金管。叉320a还可具有可选的无损伤特征,类似于上述叉120a中的那些。这些特征可以包括可以使叉320a的平坦侧面啮合或接触心房壁组织的形状弯曲。
本发明的装置,比如装置100或300,可以通过简单地顶推所述装置使其从导管端部排出而在心房附件中展开,其中所述导管端部已经插入心房附件中。滑动穿过导管的推杆可用于使所述装置移动通过所述导管。本发明的装置还可包括固定件(例如,连接于中部130的螺纹插座),输送轴或引导丝可以连接于或穿过该固定件。连接的轴或丝可用于引导所述装置通过导管,且用于所述装置在心房附件中更加受控的释放和展开。
所述装置还可包括可选的、用于使所述装置的叉机械地折叠或展开的固定件。这种固定件在将折叠的装置插入输送导管中,以及在体内展开所述装置时有用。这种固定件还可以使展开的装置复原,例如用于在导管插入手术中重新定位,或从体内完全取出。
图5示出了具有这种固定件(回收管510)的装置500,该固定件可用于使所述装置的叉110a和120a机械地折叠和展开。回收管510绕所述装置中部130同轴放置。回收管510可以沿中部130滑动。回收管510可以由任何适当的刚性生物兼容性材料制成,例如不锈钢、镍钛合金、热固性聚合物或热塑性聚合物。可以使用普通的机械设计在结构上连接回收管510和中部130。例如,可以使用可在中部130的纵向槽(未示出)中滑动的销子540连接回收管510和中部130。
回收管510的壁可以具有其他切口或槽550。当回收管510朝所述装置的扩展位置(在图5中朝左)滑动时,叉320a可以穿过槽550远离装置500的轴线扩展。槽550之间的管材料(即杆555)在结构上接合或连接管的圆柱形端部560和570。当回收管510朝装置的收缩位置(在图5中朝右)滑动时,圆柱形端部560和570分别沿中部130在叉320a和110a上滑动,并压缩或折叠叉320a和110a。装置500的结构可包括普通的棘爪、杠杆或掣子(例如销子540和棘爪580,图7),以锁定或释放装置部件的相对运动。这些棘爪可以利用适当的输送系统远程啮合或启动,以控制回收管510的滑动操作。
在图6和7中示出了可用于远程操作回收管510的输送系统600的一部分。这些图示出了输送系统600与装置500一起的协同操作。装置500安装或连接在输送系统600的装置推杆650的远端。输送系统600可以经导管护套(未示出)到达体内的位置,其中带有连接的装置500,或啮合以前放置的装置500。输送系统600可用于将回收管510推向装置的扩展位置,在此位置叉120a和320a经槽550自由扩展。或者,输送系统600可用于朝叉120a和320a上方所述装置的收缩位置牵引回收管510,以便装置的回收或再调节。输送系统600包括绕推杆650同轴的内轴610和外轴620。轴610和620分别终止于夹头630和640。轴610、620和推杆650可以相对滑动。
在操作过程中,外轴620的位置沿推杆650滑动或调节,而使夹头640啮合装置中部的棘爪580。这样,中部130可以通过保持外轴620固定而固定。而且,内轴610的位置沿推杆650滑动或调节,而使夹头630啮合回收管510的棘爪(销子540)。在中部130固定的情况下,通过在推杆上分别推入或拉出内轴610,回收管510可以沿中部130在扩展位置和收缩位置之间滑动。在回收管510处于扩展位置,通过使叉120a和320a经槽550扩展,装置500已经适当地展开之后,推杆650可以与所述装置500脱离,且输送系统600从导管护套中退出。或者,如果需要,在回收管510处于收缩位置时,通过从导管护套中拉出输送系统,连接于推杆650的收缩的装置500可以退出或重定位。
输送系统600的部件,比如内轴610、外轴620和推杆650可以由适当的金属或聚合物材料制成。
在其他的装置实施例中,由编织的弹性丝制成的单个结构可以提供上述近端盖和锚固子结构110和120的功能。编织丝可以由金属、塑料或聚合物材料或其任意组合制成。制造材料可以这样选择,即所述装置的结构可以可逆地收缩到适当的尺寸,便于经导管护套输送。在图8a、9和10a中分别示出了具有丝编装置结构1200的示例性装置800、900和1000。丝编装置结构1200可以例如使用镍钛合金丝编织的预制件制成。初始的丝编材料可以是例如管或圆柱体形式。所述丝编预制件可以例如在心轴上热处理,以获得各种圆柱形状的装置结构1200。所述圆柱形状可以根据装置用作体腔或心房附件植入物而选择。例如在图8a、9和10a中分别示出了具有不同的气球式圆柱形状的装置结构1200。装置结构1200的直径可以根据所述装置在其中展开的心房附件的形状而沿结构长度变化,以便在心房附件中形成干涉配合。装置结构1200的近端部分的直径可以这样选择,即比得上或大于心房附件口的直径,从而使展开的装置有效地拦截流经附件口的所有血液。
丝编的装置结构1200可以打结、卷曲或绑扎在一起,以封闭装置结构1200的近端。例如带子810将装置结构1200的近端绑在装置800、900和1000上。或者,装置结构1200的远端可以类似地封闭。例如,带子820在装置900和1000中封闭装置结构1200的远端。带子810和820可以由适当的材料制成,包括金属和聚合物。带子810和820例如可以由不透无线电的材料制成。带子810和820也可包括普通的固定件,比如套管或螺纹插座(未示出),用于使导管的引导丝经过所述装置或者用于使输送丝或轴连接于所述装置。
装置800、900或1000可以例如使用普通的导管设备输送到心房附件中。例如,在图8a、9和10b中示出了可用于输送所述装置的普通导管输送设备的一部分。所述设备包括外导管护套920、内护套930和引导丝940。普通的导管插入手术(包括经中隔的手术)可用于使外护套920在引导丝940上前进,穿过病人的脉管系统,到达心房附件(例如,图8b和10b中的心房附件910)。压缩的植入物装置可以使用普通的固定件连接于内护套930,比如上述的螺纹插座。通过使内护套930在引导丝940上滑动而经过外护套920,连接的装置前进到心房附件910中(例如图10b的装置1000)。
一旦连接的装置被从外护套920推到前方或排出,它们就扩展。为说明起见,图8a、9和10b示出了在外护套920外部的处于扩展状态的装置800、900和1000。在所述装置已经适当地展开之后,内护套930可以拆卸并退出(例如,图8b的装置800)。
当装置800、900或1000在心房附件(例如图8和10b的附件910)中展开时,装置结构1200的末端部分1200d使心房附件壁啮合心房附件中的锚固装置。装置结构1200的近端部分1200p延伸跨过所述附件口。
近端部分1200p可以包括血液渗透型过滤器,以防止血栓经过心房附件口。所述过滤器可以由膜材料,比如ePFTE(例如,Gortex)、聚酯(例如,Dacron)、PTFE(例如,Teflon)、硅酮、尿烷、金属或聚合物纤维,或任何其他适当的生物兼容材料制成。过滤膜可以具有导流孔。这些孔可以是织物中纤维间的间隔,或者是编织材料的丝线之间的间隔,或者可以在实心膜材料上形成,例如通过激光钻孔。在过滤膜上孔的尺寸可以选择而过滤有害尺寸的血栓。
图8a、8b和9例如分别示出了装置800和900的近端装置部分1200p上的过滤膜850。过滤膜850例如可以由一件聚酯织物制成。过滤器850可以例如通过粘接、热熔合或缝合固定到近端部分1200p的下侧丝编织物上。或者,过滤膜850可以使用细小的金属丝或聚合物纤维与近端部分1200p的下侧丝编织物交织或交编。由镍钛合金或不锈钢制成的24-72规格的细丝适于制造交织的过滤膜850。
在本发明的另一实施例中,植入物装置可以由高密度金属丝编织物制成。高密度的结构可以使植入物放入LAA中,且具有足够的结构保持位置,同时又作为阻挡血栓从LAA排出的过滤器。
在这些装置的实施例中,整个装置结构1200可以由高密度丝编材料制成。所述密度可以这样选择,即丝间孔的尺寸足够小,而可以阻止有害尺寸的血栓通过。具有适当高密度的丝编织物的装置结构1200本身可以作为血液渗透型过滤器,而不再需要单独的过滤元件。图10a和10b示出了例如具有高密度丝编织物形成的装置结构1200的装置1000。所述高密度丝编织物可以由形状记忆合金材料制成,比如镍钛合金丝。也可以使用其他的材料,比如不锈钢或聚合物纤维,制造高密度的丝编装置结构1200。在一种制造工艺中,通过交编不同尺寸的丝和/或不同材料的丝获得高密度。在所述丝编织物中,使用不同尺寸的丝可以制造适当结构强度的装置结构1200,其中丝间孔的尺寸比单种尺寸的丝编织物中可得到的尺寸更小。例如,微细的聚合物纤维可以与22-74规格的镍钛合金丝交织,而获得孔的尺寸比使用单种镍钛合金丝可得到的尺寸更小的丝编织物。孔的尺寸分布由交织的丝编织物中使用的聚合物纤维的尺寸和数量确定。这种分布可以选择,以对有害的血栓进行有效的过滤。
在另一装置实施例中,明显不同的近端盖结构可以形成或连接于前述实施例的圆柱形丝编装置结构1200上。图11a和11b例如示出了装置1000,其中近端盖1120连接于丝编装置结构1200上。近端盖1120用于覆盖和密封心房附件910的口,例如图11b所示。近端盖1120可具有丝编结构,或具有任何其他的适当结构,例如类似于前述近端盖110的叉式支撑结构。(图1a、1b和1c)。近端盖1120可包括适当的过滤膜或元件,用于过滤血栓。这些膜或元件例如可以类似于前述过滤膜850或过滤元件140(图8a和1c)。
应当理解的是,前述内容仅是本发明原理的说明,本领域的技术人员可以作出各种改进,而不脱离本发明的范围和实质。应当理解的是,术语“远端”和“近端”,“向前”和“向后”,“前”和“后”,以及其他方向和方位术语在本文中仅是为了方便而使用的,使用这些术语并非意味着固定或绝对的方位。
Claims (50)
1.一种用于过滤流经身体腔孔的血液的装置,包含:
包含过滤器的盖,所述盖位于从装置轴线径向向外延伸的多个叉上;
包含多个锚固叉的锚固结构,所述多个叉从所述轴线径向向外延伸;
沿所述轴线连接所述盖和所述锚固结构的连接结构,
其特征在于所述装置具有基本上H形的截面,且所述盖和所述锚固结构位于所述身体腔孔的相对两侧。
2.如权利要求1所述的装置,其特征在于所述叉受到偏压,而使所述多个叉将所述盖压在包围所述腔孔的身体组织上,且所述多个锚固叉受到偏压,而从与所述盖相对的侧面压住包围所述腔孔的身体组织。
3.如权利要求1所述的装置,其特征在于所述过滤器包含血液渗透型过滤器。
4.如权利要求3所述的装置,其特征在于所述血液渗透型过滤器包含从含氟聚合物、硅酮、尿烷、金属纤维、聚合物纤维、聚酯纤维及其组合构成的组中选择的材料。
5.如权利要求1所述的装置,其特征在于所述叉可以大致平行于所述装置轴线折叠。
6.如权利要求1所述的装置,其特征在于所述叉包含从金属、塑料、聚合物、金属合金、形状记忆合金及其组合构成的组中选择的弹性材料。
7.如权利要求6所述的装置,其特征在于所述叉包含镍钛合金。
8.如权利要求1所述的装置,其特征在于所述叉和所述连接结构是由实心管状预制件制成的。
9.如权利要求8所述的装置,其特征在于所述实心管状预制件包含形状记忆合金管。
10.如权利要求1所述的装置,其特征在于所述锚固结构与所述腔孔一侧的体腔形成干涉配合。
11.如权利要求10所述的装置,其特征在于所述锚固叉具有用于接触所述体腔壁的大致平坦的表面。
12.一种用于过滤流经心房附件口的血液的方法,包含:
提供具有基本上H形截面的装置,所述装置包含位于从装置轴线径向向外延伸的多个叉上的盖,所述盖包括过滤器;
通过沿所述装置轴线的连接结构连接于所述盖的锚固结构,所述锚固结构包含多个从所述轴线径向向外延伸的锚固叉;
将所述装置的一部分插入所述心房附件中;
使所述盖和所述锚固结构在所述口的相对侧定位。
13.如权利要求12所述的方法,其特征在于所述定位过程包含夹紧所述盖和所述锚固结构之间的口组织,从而引导血液流经所述过滤器。
14.如权利要求13所述的方法,其特征在于所述插入过程还包含大致平行于所述装置轴线折叠所述叉;
通过导管输送具有折叠的叉的所述装置;
从所述导管排出所述装置,使所述叉可以展开。
15.一种用于过滤流经心房附件口的血液的装置,包含:
包含过滤器的盖,所述盖延伸跨过所述口;
锚固结构,包含多个从连接结构径向向外延伸的锚固叉,所述连接结构连接所述锚固结构和所述盖,
其中所述锚固结构具有大致V形的截面,其中顶点远离所述盖,且所述锚固结构啮合所述心房附件的内壁,而使所述装置保持在适当位置。
16.如权利要求15所述的装置,其特征在于所述锚固叉受到偏压,而使所述锚固结构利用钩式作用啮合所述内壁,而阻止所述装置向外移动。
17.如权利要求15所述的装置,其特征在于所述锚固叉可以大致沿所述连接结构折叠。
18.如权利要求15所述的装置,其特征在于所述锚固叉包含从金属、塑料、聚合物、金属合金、形状记忆合金及其组合构成的组中选择的弹性材料。
19.如权利要求18所述的装置,其特征在于所述叉包含镍钛合金。
20.如权利要求15所述的装置,其特征在于所述叉和所述连接结构是由实心管状预制件制成的。
21.如权利要求15所述的装置,其特征在于所述盖还包含多个从所述连接结构径向向外延伸的叉。
22.如权利要求21所述的装置,其特征在于所述多个叉受到偏压,而使所述叉将所述盖压在包围所述口的心房壁组织上。
23.如权利要求21所述的装置,其特征在于所述多个叉和所述锚固结构包含形状记忆合金。
24.如权利要求15所述的装置,其特征在于所述过滤器包含从含氟聚合物、硅酮、尿烷、金属纤维、聚合物纤维、聚酯纤维及其组合构成的组中选择的材料。
25.一种用于过滤流经身体孔腔的血液的装置,包含:
包含过滤器的盖;
锚固结构;
连接所述盖和所述锚固结构的连接结构;
位于所述连接结构上的可滑动的回收管;
其中所述盖和所述锚固结构可沿所述连接结构可逆地折叠,所述回收管滑动到第一位置,折叠所述盖和所述锚固结构,且所述回收管滑动到第二位置,展开所述盖和所述锚固结构。
26.如权利要求25所述的装置,其特征在于所述盖和所述锚固结构还包含从所述连接结构径向延伸的叉,该叉可以大致沿所述连接结构折叠。
27.如权利要求26所述的装置,其特征在于所述回收管包含槽,当所述回收管滑动所述第二位置时,折叠的叉经该槽展开,且远离所述连接结构径向延伸。
28.如权利要求26所述的装置,其特征在于所述回收管包含端部,当所述回收管滑动到所述第一位置时,所述端部下压所述叉且在所述叉上滑动,而使所述叉沿所述连接结构折叠。
29.如权利要求25所述的装置,其特征在于所述回收管和所述连接结构还包含棘爪,所述棘爪可以啮合而锁定所述回收管和所述连接结构的移动。
30.一种用于可逆地植入权利要求29所述的装置的输送系统,包含:
导管,当所述回收管处于所述第一位置时,所述装置装在所述导管中;
第一轴,可滑动经过所述导管,所述第一轴具有第一夹头,该夹头可以啮合所述棘爪,而使所述连接结构的运动锁定于所述第一轴的运动;
第二轴,可滑动经过所述导管,所述第二轴具有第二夹头,该夹头可以啮合所述棘爪,而使所述回收管的运动连接于所述第二轴的运动;
第三轴,用于使所述装置移动经过所述导管。
31.一种通过导管将植入物装置可逆地放入体腔中的方法,包含:
提供植入物装置,包含:
管状部分;
可以沿所述管状部分可逆地折叠的结构;
位于所述管状部分上的滑动管;
其中所述滑动管滑动到第一位置而折叠所述结构,且滑动到第二位置而展开所述结构,所述管状部分和所述滑动管还包含可以啮合而锁定其运动的棘爪;
在所述滑动管处于所述第一位置时移动所述装置,使其经过所述导管到达所述体腔;
使所述滑动管滑动到所述第二位置,使所述结构展开。
32.如权利要求31所述的方法,其特征在于还包含:
提供可滑动经过所述导管的第一轴,所述第一轴具有第一夹头,该夹头可啮合所述棘爪,而使管状部分的运动锁定于所述第一轴的运动;
提供可滑动经过所述导管的第二轴,所述第二轴具有第二夹头,该夹头可以啮合所述棘爪,使所述滑动管的运动连接于所述第二轴的运动;
提供第三轴,用于使所述装置移动经过所述导管;
使用所述第三轴,在所述管处于所述第一位置时移动所述装置,使其经过所述导管进入所述体腔内;
使用所述第一轴,锁定所述管状部分的运动;
使用所述第二轴,使所述滑动管的运动连接于所述第二轴的运动;
使所述第二轴滑动,从而使所述滑动管在所述第一和第二位置之间移动。
33.一种使通过权利要求32的方法放入体腔内的植入物装置的放置过程逆转的方法,包含:
使用所述第一轴,锁定所述管状部分的运动;
使用所述第二轴,使所述滑动管的运动连接于所述第二轴的运动;
使所述第二轴滑动,将所述管移动到所述第一位置;
使用所述第三轴,在所述管处于所述第一位置时使所述装置移动,进入所述导管中。
34.一种用于过滤流经心房附件口的血液的装置,包含:
近端部分;
连接于所述近端部分的远端部分;
位于所述近端部分上的过滤器,其中所述远端部分包含圆柱形丝编结构,且所述近端部分包含所述圆柱形丝编结构的封闭端,其中所述过滤器位于所述近端部分上,且所述丝编结构的形状可以使其在所述心房附件中干涉配合,且所述近端部分延伸跨过所述口。
35.如权利要求34所述的装置,其特征在于所述丝编结构是弹性的,且所述结构可以可逆地压缩,以便通过导管输送。
36.如权利要求34所述的装置,其特征在于所述封闭端包含封闭所述圆柱形丝编结构的管状端部的带子。
37.如权利要求35所述的装置,其特征在于所述带子包含用于使输送轴连接于所述装置的固定件。
38.如权利要求34所述的装置,其特征在于所述圆柱形丝编结构包含从金属丝、塑料丝、聚合物丝、金属合金丝、形状记忆合金丝及其组合构成的组中选择的。
39.如权利要求38所述的装置,其特征在于所述圆柱形丝编结构包含镍钛合金丝。
40.如权利要求34所述的装置,其特征在于所述过滤器包含从含氟聚合物、硅酮、尿烷、金属纤维、聚合物纤维、聚酯纤维及其组合构成的组中选择的材料。
41.如权利要求34所述的装置,其特征在于所述过滤器包含与所述圆柱形丝编结构交织的材料。
42.如权利要求41所述的装置,其特征在于所述交织材料包含从金属丝、塑料丝、聚合物丝及其组合构成的组中选择的材料。
43.如权利要求34所述的装置,其特征在于所述过滤器包含从含氟聚合物、硅酮、尿烷、金属纤维、聚合物纤维、聚酯纤维及其组合构成的组中选择的材料。
44.如权利要求34所述的装置,其特征在于所述圆柱形丝编结构还包含:
丝间孔尺寸基本上小于有害尺寸的血栓的编织物。
45.如权利要求34所述的装置,其特征在于所述过滤器包含连接于所述近端部分的盖,其中所述盖啮合包围所述口的心房壁组织,且所述盖包括过滤元件。
46.一种用于过滤流经心房附件口的血液的装置,包含:
近端部分;
连接于所述近端部分的远端部分;
其中所述远端部分包含圆柱形丝编结构,且所述近端部分包含所述圆柱形丝编结构的封闭端,且所述丝编结构的形状可以使其在所述心房附件中干涉配合,且所述近端部分延伸跨过所述口,所述丝编结构包含丝间孔尺寸基本上小于有害尺寸的血栓的编织物。
47.如权利要求46所述的装置,其特征在于所述丝编结构是弹性的,且所述结构可以可逆地压缩,以便经导管输送。
48.如权利要求46所述的装置,其特征在于所述圆柱形丝编结构包含从金属丝、塑料丝、聚合物丝、金属合金丝、形状记忆合金丝及其组合构成的组中选择的。
49.如权利要求48所述的装置,其特征在于所述圆柱形丝编结构包含镍钛合金丝。
50.一种用于将权利要求47所述的装置植入体腔中而过滤血液流的方法,包含:
经导管输送具有压缩结构的所述装置;
从所述导管排出所述装置,而使所述压缩结构扩展。
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- 2002-03-08 EP EP02713797A patent/EP1365702A2/en not_active Withdrawn
- 2002-03-08 CA CA002441119A patent/CA2441119A1/en not_active Abandoned
- 2002-03-08 IL IL15773202A patent/IL157732A0/xx unknown
- 2002-03-08 CN CNA028061349A patent/CN1529571A/zh active Pending
- 2002-03-08 US US10/094,730 patent/US20030057156A1/en not_active Abandoned
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- 2002-03-08 JP JP2002570937A patent/JP2005508201A/ja active Pending
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US11213411B2 (en) | 2017-02-24 | 2022-01-04 | Tsinghua University | Shape memory material-based minimally invasive implantation with end part self-expanding structure |
Also Published As
Publication number | Publication date |
---|---|
WO2002071977A3 (en) | 2003-06-26 |
EP1365702A2 (en) | 2003-12-03 |
IL157732A0 (en) | 2004-03-28 |
US20030057156A1 (en) | 2003-03-27 |
WO2002071977A2 (en) | 2002-09-19 |
JP2005508201A (ja) | 2005-03-31 |
CA2441119A1 (en) | 2002-09-19 |
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