CN1842354A - 医疗设备锚件及置放系统 - Google Patents
医疗设备锚件及置放系统 Download PDFInfo
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Abstract
一种用于在医疗植入设备已经停止在血管或其他身体通道内的预定位置以后锚定该设备的方法和装置。提供一种锚件置放系统(22),其容纳一个或多个独特构形的可展开锚件(28)其连接到医疗植入设备(10)。锚件(28)以非展开的形态被保持容纳直到医疗植入设备(10)停止在体内的预期位置,然后锚件(28)被主动推动通过身体壁(12)从第一侧到第二侧,在那里每个锚件(28)在锚杆(18)的相对侧向外展开。为了主动推动锚件(28),驱动轴(50)延伸回到触发单元(68)其当被启动时会使驱动轴(50)在某方向上驱动锚杆(18),这样导致锚件(28)被推动通过身体壁(12)。
Description
本申请为2003年11月12日提交的申请序号10/705226的申请的部分继续申请。
技术领域
近来,在医疗技术上的进步已经发展出多种用于在人体中永久或暂时植入的医疗设备。对这样的设备的有效定位证实为一项非常困难的任务,而将植入设备保持在想要的位置一段较长时间经常是更加困难。特别是,如果植入设备仅要暂时保持并设计成便于随后的取出的话。
背景技术
许多医疗植入设备设计为折叠以插入到导管或其他置放单元内,并在置放后弹出而展开成预定形状。在移开置放单元后,这些自体展开设备中的许多主要依靠设备与身体脉管或通道的壁之间的接触而将设备保持在适当的位置。不幸的是,身体脉管或通道的大小或者其中通过的血液或其他流体的流动改变会使医疗植入物移动和改变位置。
使医疗植入设备正确定位并取向,并且保持这种位置和取向是极其重要的。否则,无法达到这样的治疗设备的有效作用。将这样的设备以预期取向移动到合适位置经常是非常困难的,一旦完成以后,关键的是不再出现另外的移动。
在防止医疗植入设备的移动的尝试中,经常在设备上形成刚性钩以在当植入设备展开而与身体脉管或通道的壁接触时与该壁接合。在几周后,内皮生长到刚性钩上,其不能在收回压力的影响下容易地弯曲,医疗植入设备则被埋入的钩锁定到合适的位置上。对永久植入来说这或许是可以接受的,但如果医疗植入设备要在几周后几个月以后被取出的话,刚性钩就不是一个可行的选择。
为了通过从包膜内皮层中收回锚件钩并不对身体脉管或通道有产生实质损害的危险而便于取出先前植入的医疗设备,钩被制为当受到大于最大移动力的收回力量时会变直。Ravenscroft等的美国专利6007558和6258026示出一种钩其形成为弯的并响应收回的力而变直,Silmon的美国专利4425908,Herms等的4817600,Lefebvre的5108418,Rasmussen等人的5133733,Elnounou等人的5242462,Irie的5370657,Smith的5601595,Gelbfish的5800457以及Chevillon等人的5853420,都公开可展开的医疗植入设备,其中许多带有锚件钩。
虽然锚件钩在许多情况中有效,但有许多缺点,使其难以正确定位和保持医疗植入设备的位置。在现有设备中,锚件钩是因为设备展开与身体脉管或通道的壁接触而实现接合,如果发生了设备在展开期间从预期位置移开并接触壁的话,难以容易地重新定位该设备。钩的锚定功能与设备的展开是不可分开的。
在钩的操作与医疗植入设备的展开联系在一起的情况中,有可能有这样的情况即一个或多个钩没有正确与身体脉管或通道的壁接合而导致设备变得偏心的情况。有时候设备的纵向移动会接合上错误的钩,但这种移动也能改变设备的位置。
此外,钩的结构即在单一方向上从杆到尖端弯曲也证实是一个缺点。当钩用于将医疗植入设备锚定在血管内时,当它与血管壁接合时钩取向为在正常血流流过血管的方向上弯曲是很重要的。这样当接合时,钩会从杆朝向尖端基本在血管的纵向轴的方向上延伸,而能够有效地阻止医疗植入设备因在流过血管的通常的方向上的血流的压力下而导致的移动。然而,也有会导致血液在血管中回流的情况,由回流产生的对设备和锚件钩的压力会使钩后退并与血管脱离,因而改变设备在血管内的取向并引起植入性能的有害变化。
最后,即使植入设备的钩与血管壁正确接合,也存在这样的情况,其导致血管壁随后向外膨胀到会使钩容易脱离的程度。
发明内容
本发明的第一个目的是提供一种新的和改进的定位及锚定医疗植入设备的方法,其包括在与锚件连接的医疗植入设备到达预期位置并停止移动之后主动推动一个或多个锚件通过身体壁。
本发明的第二个目的是提供一种新的和改进的医疗设备锚件及置放系统,其中一个或多个锚件被主动推动通过身体壁。一旦锚件已经通过壁,它从至少锚件杆的两个相对侧向外展开。
本发明的第三个目的是提供一种新的和改进的医疗设备锚件其设计为从第一侧到第二侧穿透身体壁并在穿透后从至少锚件杆的两个相对侧向外展开。
本发明的第四个目的是提供一种新的和改进的医疗设备锚件其设计为从第一侧到第二侧穿透身体壁并在穿透后以独特的方式从至少锚件杆向外展开。展开后的锚件设计为靠在血管的第二壁上压缩加载,并响应在与血管的纵轴成角度所施加的力而改变形态以提高由此提供的锚定功能。
本发明的第五个目的是提供一种新的和改进的医疗设备锚件其设计为从第一侧到第二侧穿透身体壁并在穿透后以独特的方式从至少锚件杆向外展开。锚件从锚件杆向外展开成一个或多个环,每个环弯回来而越过锚件杆。环的越过锚件杆的部分形成为与血管的第二壁接合并使锚件响应一施加到附在锚件上的医疗设备的力或者由血管壁的扩张产生的力而抵靠到血管的第二壁压缩加载。
本发明的第六个目的是提供一种新的和改进的医疗设备锚件及置放系统,其中一个或多个锚件在与锚件连接的医疗植入设备到达预期位置并停止移动之后被主动推动通过的身体壁。该锚件置放系统不需要将与其连接的医疗植入设备压缩及/或收回而便于锚件的移出和再插入。
本发明的第七个目的是提供一种新的和改进的用于医疗植入设备以将该设备锚定到血管或其他身体通道内的合适位置的锚件及锚件置放系统。一旦该医疗植入设备被定位并展开而与血管或身体通道的壁接触,那么锚件置放系统主动推动一个或多个锚件通过血管或通道壁,其中锚件从锚杆的相对侧向外张开。锚件置放系统使锚件能被移出并然后再插入通过壁而不需要折叠医疗植入设备。
本发明的第八个目的是提供一种新的和改进的锚件及锚件置放系统,其用于医疗植入设备以将该设备锚定到血管或其他身体通道内的合适位置的同时便于以后收回该设备。一旦该医疗植入设备展开而与血管或身体通道的壁接触,那么锚件置放系统主动推动一个或多个锚件通过该壁,锚件随后从锚杆的相对侧向外张开。锚件形成为响应预定的力量相对锚杆的纵轴向后收缩以能够通过壁移出。
本发明的第九个目的是为血块过滤器提供一种新的和改进的锚件及锚件置放系统,其中置放系统包括拉长的管状的容纳锚件的过滤器腿。一旦过滤器腿被从导管或置放管弹出并展开而与血管壁接触,锚件置放系统主动从过滤器腿向外推动锚件并通过血管壁从第一侧到第二侧,在那里锚件从锚杆的相对侧向外张开抵靠在壁的第二侧上。每个锚形成为响应预定的力量相对锚杆的纵轴向后收缩以能够通过壁移出,这使得锚件可以被移出回到过滤器腿中并然后被再次推动通过血管壁而不需要折叠过滤器腿。
本发明的第十个目的是为血块过滤器提供一种新的和改进的锚件及锚件置放系统,其中置放系统包括拉长的管状的容纳锚件并展开而与血管壁接触的过滤器腿。与血管壁接触的过滤器腿的部分形成有侧面开口,过滤器腿设计为便于通过横穿过滤器腿的侧面开口弹出锚件。一旦过滤器腿展开而与血管壁接触,锚件置放系统主动从过滤器腿的侧面开口侧向向外推动锚件并通过血管壁从第一侧到第二侧,在那里锚件从锚杆向外张开抵靠在血管壁的第二侧上。
通过提供容纳一个或多个独特结构的与医疗植入设备连接的锚件的锚件置放系统,能达到本发明的这些以及其他目标。锚件保持容纳状态直到医疗植入设备已经停止移动到达在身体内的预期的位置,然后锚件被主动推动通过身体壁从第一侧到第二侧,在那里每个锚件从单一杆结构张开。为推动锚件,驱动轴从锚件支撑套管向后延伸到触发单元,该触发单元在被启动后,使驱动轴在一方向上移动锚件支撑套管以推动锚件通过身体壁。触发单元可以是弹簧动力的或螺线管动力的。
附图说明
图1示出安装在导管内的具有根据本发明形成的锚的血块过滤器的剖视图;
图2示出图1中的锚件支撑毂和腿保持套管的透视图;
图3示出用于图2中的腿保持套管的锁定套管的透视图;
图4示出用于图1中的锁定套管和锚件支撑毂的操作机构的剖视图;
图5示出在图1的导管近端的用于推动锚件支撑毂的弹簧动力的触发单元的透视图;
图6示出图1的展开的血块过滤器的透视图;
图7示出用于图6的血块过滤器的展开锚件的透视图;
图8示出本发明展开锚件的第二实施例的透视图;
图9示出本发明展开锚件的第三实施例的透视图;
图10示出本发明的单个锚件和锚件置放系统的剖视图;
图11示出本发明展开锚件的第四实施例的透视图,其展开而形成具有从上面越过并延伸超出锚杆的壁接合部的闭合环;
图12示出本发明展开锚件的第五实施例的透视图,其展开而形成具有从下面越过并延伸超出锚杆的壁接合部的闭合环;
图13示出被固定到包含血块过滤器腿的锚件的末端的锚件引导套管的侧视图;
图14示出图13的锚件引导套管的剖视图;
图15示出图14的锚件引导套管的变型的剖视图;
图16示出展开的血块过滤器的透视图,其变化为从过滤器腿的侧面在腿的远端上弹出锚件,锚件为展开;
图17示出图16的过滤器的过滤器腿的端截面的前视图,锚件部分展开;
图18示出图16的过滤器的过滤器腿的端截面的前视图,锚件全部展开。
具体实施方式
参考图1-2,用10总体标示包括根据本发明的锚件的血块过滤器。该过滤器为说明而以腔静脉过滤器示出,形成有多个细长的腿12,其固定到并从腿保持套管14向外延伸。该细长腿由小的端部开口的管形成,每个管有一个在腿保持套管敞开的第一开口端16。多个长的锚杆18附在锚件支撑毂20的远端,当腔静脉过滤器在导管或置放管22中折叠时该锚件支撑毂20从腿保持套管隔开。每个杆18从锚件支撑毂20延伸到管状腿12的第一开口端16并通过腿到远端24到邻近管状腿的第二开口端26的位置。锚件28以下面要描述的方式形成在每个杆18的远端。
形成细长腿12及长的锚杆18的材料使得它们可以向过滤器10的纵轴压缩以便被导管22置放。一旦过滤器被从导管中弹出,腿12和杆18设计为从如图6所示的过滤器纵轴向外展开以使腿与血管壁接触。虽然可以用弹性金属和适当的塑料形成腿12及/或杆18,最好用合适的形状记忆材料形成锚杆18及在大多数情况下形成腿12。如果使用如镍钛合金这样的温度响应形状记忆材料,可以通过与转变温度有关的温度变化实现材料的马氏体和奥氏体之间的转变。在马氏体状态,材料变软,由此允许其形成的过滤器被压缩和装入导管中。如果材料的转变温度设定为正好在或接近于正常身体的温度,那么当过滤器被从导管中弹出并展开而重新回到记忆的形状时,过滤器腿会变到奥氏体状态。
为了通过导管22置放,腿保持套管14被锁定套管30锁在锚件支撑毂20,该锁定套管30当在如图1所示的锁定位置时既包围锚件支撑毂也包围腿保持套管。在解锁状态,如图3所示锁定套管从腿保持套管纵向向后移动。两个弹性臂32被连接到锚件支撑毂后面的壳体34的一端并向外延伸到腿保持套管的相对侧上。每个弹性臂的自由端弯曲而形成弓形插销组件36,其位于形成在腿保持套管上的锁定突起38上方并在图1的锁定位置上与该突起啮合。当锁定套管30朝向腿保持套管14的锁定位置移动时,它使弹性臂32和34压在一起并且弓形插销组件与锁定突起啮合。当锁定套管到达图1的完全锁定位置时,弓形插销组件滑入到锁定套管中的槽40内而腿保持套管被明确锁到锚件支撑毂上。然而,当锁定套管从腿保持套管纵向移开时,插销组件36的弓形结构允许它们滑出槽40,当锁定套管移动得更远时,弹性臂32向外移动使得弓形插销组件与锁定突起38脱离。
安装锁定套管30用于朝向及远离中心杆42,其从邻近腔静脉过滤器10的远端延伸回到导管22的入口端。中心杆的远端形成有多个间隔开的内腔46,每个内腔安装多个中心臂48之一。中心杆移动这些中心臂到导管22外面在腔静脉过滤器后面,这些中心臂然后向外展开以与血管壁接合并确定过滤器的引导端的中心。这些中心臂可以由弹性金属或塑料形成,但最好用如镍钛合金的形状记忆材料来形成。
为了控制腔静脉过滤器10的位置及随后的从腿12的第二开口端弹出锚件28,长条的驱动轴50从导管22的入口或近端52通过导管延伸到具有锚件支撑毂20的可释放连接件54。该可释放连接件可以是任何适当的通过在导管近端对驱动轴的操作便于将驱动轴从锚件支撑毂释放的连接件,例如所示的螺纹连接件、钩和孔连接器、啮合钩连接器,以及已知的扭曲啮合及释放连接器。该驱动轴通过中心杆42,并可相对其既能转动也能纵向移动。
如图4所示,驱动轴通过锁定套管操作器56并相对该操作器既能转动也能纵向移动,该操作器通过壳体34中的槽58和60。在62和64锁定套管操作器被固定到锁定套管30并在锁定套管操作器从槽58和60中的腿保持套管中操作时起作用以移动锁定套管离开腿保持套管14。借助于固定到驱动轴的止动件66驱动轴起作用以从锁定位置移动锁定套管并定位以啮合锁定套管操作器。
当导管22到达血管内的预期位置时,腔静脉过滤器10和中心臂48通过或者将它们从导管中弹出或者把导管从它们周围拉回来而被露出来。这种情况细长腿12和中心臂48会向外展开而与血管壁接合。然而,锚件28会保持封装在细长腿中,这使得在细长腿展开直到到达某个精确位置之后,腔静脉过滤器相对血管移动。如果需要实质性的位置改变,中心臂和腔静脉过滤器可以被拉进导管内并随后重新布置到新的位置。
当腔静脉过滤器在血管内的预期位置而细长腿12与血管壁接合,锚件28此时被主动从细长腿的第二开口端26弹出以穿过血管壁。为了实现在细长腿与血管壁接合后的此次锚件的主动弹出有足够力量而能够穿透血管壁,驱动轴50被连接到在导管22的近端或入口端70处的触发单元68。触发单元可以由多种已知的能够给予驱动轴纵向力的单元形成。电动螺线管单元以及许多弹簧动力单元可以用于此目的。在图5中,触发单元由通常用于使针穿透患者皮肤以提供血液样品的那种类型的常规发射型射针器形成。这样的射针器包括中空体72,该中空体包含能够在中空体内前后轴向移动的柱塞。柱塞被卷簧76围绕,当柱塞通过端钮78被拉回来准备发射时卷簧76被压缩。准备发射的柱塞被扳机80保持在适当的位置,由按钮82触发扳机80以释放柱塞。当柱塞被释放时,卷簧76将柱塞推向在附在中空体上的头锥罩86的开口84。发射型射针器正常的使用中,针被固定到柱塞的端部88并被释放的柱塞推动穿过开口84并进入患者的皮肤。在图5中,驱动轴50固定到柱塞的端部88,当装好的柱塞被释放时,驱动轴被纵向推动以驱动锚件支撑毂20朝向腿保持套管14。这使得长杆18纵向移动通过细长腿12而将锚件推出并穿过血管壁。图6示出展开的腔静脉过滤器10,其中锚件28的结构为在通过血管壁后要呈现的形状。下面描述这些锚件的结构和操作。
腔静脉过滤器10的一个显著的优点是它可以在即使锚件已经到位的情况下再定位而不需要将整个过滤器撤回到导管22中。只要细长腿与血管壁接触,通过使驱动轴50移动锚件支撑毂20离开腿保持套管14,就可以将锚件28从血管壁上撤下并返回到细长腿中。这种情况下腔静脉过滤器可以被重新定位,可以重新使触发单元68的柱塞74处于发射状态,并再次弹出锚件穿透血管壁。
一旦腔静脉过滤器10被正确定位并再血管中锚定,驱动轴50从锚件支撑毂20上分离并被拉动离开锚件支撑毂使得止动件66与锁定套管操作器56接合并移动其离开锚件支撑毂。这使得锁定套管30移动离开腿保持套管14从而弹性臂32向外弹而插销组件36与锁定突起38分离。此时可以将中心杆42、锁定套管30、驱动轴50和壳体34通过导管22拉回来,留下腔静脉过滤器在血管内适当的位置上。
为了随后移出先前锚定的腔静脉过滤器,可以使用与过滤器主体接合的标准的身体取出装置。例如,要与取出装置接合的钩子可以附在锚件支撑毂20上。
锚件28形成在长的锚杆18的近端,在细长腿12中锚件采用与它们整体形成的杆相同的外形。杆在外形上与细长腿的内部形状一致以便能在细长腿内容易移动,通常杆是圆柱形的,有一个形成锚件引导端的尖端。在图7中示出图6的锚件的放大图。
参考图7,管状锚杆18在90处中心分开而形成锚件的相对的臂92和94。每个臂的内表面96和98是平的而每个臂的保持面100是弓形的,这样当臂的内表面接触时,直的管状端部形成在每个长杆18的末端。每个长杆的尖端在锚件的臂92和94上形成尖端102和104。
在图6和图7中示出了锚件的展开形状记忆外形。当锚件支撑毂20被驱动朝向腿保持套管14时,每个具有接触的内表面96和98的锚件以直的外形被从细长腿12中弹出。每个锚件的尖的引导端会穿透血管壁从而整个锚件通过血管壁,在该处锚件展开成图7所示的它的形状记忆外形。此时细长腿的末端26接合血管壁的内表面同时臂92和94的尖端102和104接合血管壁的外表面。重要的是请注意到,展开锚件的一部分,在此例中为臂92和94,在杆18的相对侧向外延伸,从而在锚件臂的平面上的任一方向上的力都不会以某种方式,如在单一钩仅在一个方向上从支撑杆向外延伸的情况中会发生的那样,移走锚件。为了提供对意外移走情况的更多的保护,锚件28如图7所示取向,从而锚件的相对臂92和94相对血流通过过滤器的纵向方向106横向展开。这样顺行或逆行的血流产生的力不会移走锚件,但由于锚件臂每个形成为直径极小的杆18的一半,沿杆的纵轴的移出力允许锚件臂一起移动而便于锚件从血管壁移出。
重要的是注意到锚件臂92和94向外向后朝向杆18弯曲而与血管壁的外表面接合。这使得当垂直血管的纵轴的力被施加到与锚件连接的医疗设备上时,锚件抵靠血管壁上加载为压缩状态。这种压缩的情况极大地提高锚件所提供的锚定功能,便于有效使用非常小的精细的锚件组件。
锚件28可以采用多种形式,只要锚件会从在细长腿12内的直的形态展开为锚件至少在杆18的两个相对侧上向外延伸的形状记忆形态。在图8中,锚件28延伸为螺旋形态,以便完全围绕杆18延伸。这里杆并不象图7所示那样分开,而是杆的完整末端被用于形成螺旋108。在所有情况中锚件的从细长腿12形成的第一端为承接锚件尖端的直的部分110,该部分在后面的形成弯折的部分显露之前,先通过血管壁。图7和图8的两个锚件在展开后都会因抵靠血管壁的弹力作用而变平。
为了形成图9中的锚件28,杆18在末端变平并在90处分开而形成两个相对的平的臂112和114,其在杆的相对侧向外展开。这些臂从细长腿12形成为直的部分,其通过血管壁然后裂开并在116和118向外弯曲而形成臂。这些臂保持靠在血管壁的外表面上并在腔静脉过滤器中取向为相对血液流过过滤器的纵向方向为横向。
对一些医学应用来说,都存在需要一种单个锚件将设备拴在身体脉管或身体的壁上。与前面描述的关于多锚件腔静脉过滤器10相似的装置可以用于布置图10中的单个锚件120。该单个锚件120形成在装在细长管124上的的锚杆122的远端,杆122和管124都有如关于细长腿12和长杆18所述的形状记忆材料形成,但通常在长度上要比细长腿12和杆18短得多。管保持套管126以腿保持套管14操作以保持细长腿12相同的方式来保持单个管124,该管保持套管被以前面所述方式操作的锁定套管(未示出)和弹性臂32接合。驱动轴50在导管22的入口端连接到扳机单元68,并还连接到类似可释放连接件54的可释放连接件128。该可释放连接件固装在杆支撑毂130并通常与连接到锚杆的近端的管保持套管126隔开。
驱动轴50可在类似于中心杆42的控制杆132上移动,中心杆42操作以纵向移动杆支撑毂和管保持套管以从导管22中排出包含锚件120的管124。此时管124采取预定形状以使锚件相对容纳锚件的身体壁定位。这时可操作触发单元68使驱动轴50将杆支撑毂130朝向管保持套管126移动以驱动锚件120通过身体壁。锚件120由形状记忆材料形成,其采用的形态和操作的方式可以象前面描述的锚件一样。一旦锚件被置放出去,可操作弹性臂32释放管保持套管126,可以从可释放连接件128上放开驱动轴,从而驱动和控制杆及在某些情况中导管可以被撤出。如果锚件的目的是将导管锚定在合适的位置,那么在导管和锚件之间提供系绳134,导管不会被驱动和控制杆收回。
在某些情况中,导管22可以是双内腔导管,其具有包含所述锚机构的第一腔136和包含要被锚件120锚定的可植入医疗设备140的第二腔138。在这种情况中,在锚件和可植入医疗设备中连接有系绳142,一旦锚件到达合适位置,可植入医疗设备就被从导管中弹出。
当可能使用导管来使锚件120相对身体壁正确定位时,管124和管保持套管126可以省去而被导管内腔代替。此时,驱动轴50会纵向驱动杆支撑毂130以驱动锚件从导管内腔并通过身体壁。
图11和12分别示出锚件144和146,其每一个在展开的形状记忆形态形成为单个的闭合的环。当锚件支撑毂20被推向腿保持套管14时,每个锚件144或146以与长锚杆18同向延伸的直线形态被从细长腿12中弹出。每个锚件的末端,其可由148示出所标示,会穿透包含腔静脉过滤器10或其他要被锚定的医疗植入设备的血管壁150,这样整个锚件通过并抵靠在血管壁的外表面上展开。在它的形状记忆展开形态中,锚件144从锚杆向外弓形延伸并成环回越过并延伸超过锚杆而形成单个闭合环152。环152在154接合血管壁150的外表面并抵靠在血管壁上以压缩态加载;这种压缩会响应在任何方向施加的会使环152更加抵靠在血管壁上的力而增大。当这些力增大时,环152改变形态并在尺寸上缩小,变得更坚硬同时环的更多部分被压过锚杆18,由此增大锚件的锚定力。
不同于锚件114其取向为限制在锚杆18和血管壁150之间的角形空间,锚件146取向为在此角形空间之外。在其形状记忆展开形态锚件从锚杆向外弓形延伸并成环回越过并延伸超过锚杆而形成单个闭合环156,环156抵靠在血管壁上以压缩态加载。然而,由于锚件146的取向和形态,当在锚件上的力增大时,环变直而不减小尺寸而可以用比拉出锚件144所需的更小的力将其拉出来。
锚件144和146都可构建为通过分开杆18和形成与由图7的臂92和94形成的开环相似的双重相对的闭合环而提供双重环的锚。然而,变型锚件144和146的双重闭合环都会以图11或图12中所示的方式,在锚杆上方或下方弓形延伸。
较好的作法是保证一旦布置了锚件,包含过滤器腿12的锚件的远端24不会随着弹出的锚件通过血管的侧壁。这一点可以根据本发明通过在过滤器腿的一部分上形成侧面开口而实现,过滤器腿接触血管壁而侧面开口隔开设置在过滤器腿的远端上。一旦过滤器腿展开而与血管壁接触,那么锚件就被通过该过滤器腿的侧面开口侧向弹出。这时锚件会在过滤器腿的远端以上的位置通过血管壁,由此确保避免过滤器腿的远端随锚件通过血管壁的可能性。
已经发现将图13、14和15所示出类型的单独的锚件引导套管158附在每个包含过滤器腿的锚件的远端24上。锚件引导套管具有为过滤器腿的远端向内部支座162敞开的开口端160。可用任何已知的手段如摩擦配合、焊接、热膨胀或粘结将过滤器腿的末端固定到支座162内。内部通道164将支座162连接到形成在锚件引导套管中的侧面开口166,并且此侧面开口与锚件引导套管的闭合端168间隔开。内部通道被从开口166的下端向上弯曲到内部通道的相对侧的弯曲导壁170封闭。
当触发单元68被激发时,每个长锚杆18将锚件28移向锚件引导套管158的闭合端168并与封闭内部通道164的弯曲的导壁170接合。锚件然后被沿该弯曲导壁引导使得随着锚件被通过侧面开口166弹出并侧向通过血管壁时杆18弯曲。锚件引导套管158可以由钽形成以在荧光透视下提供较高的可行性。
为了防止由弹出锚件28施加到弯曲的导壁170上的力引起过滤器腿12相对血管纵向移动,可以在或者锚件引导套管158或者过滤器腿12或者两者上都形成倒钩172。当过滤器腿接触血管壁时,这些倒钩与血管壁接合,并倾向于穿透并防止过滤器腿朝向锚件引导套管的闭合端168纵向移动。
为了免除对锚件引导套管158的需要,如图16到18所示,侧面开口174可以直接在过滤器腿12中形成并与远端24隔开以在激发触发单元68时便于侧向弹出锚件。管状过滤器腿在侧面开口174下端和过滤器腿的远端之间封闭,从而锚件会通过侧面开口从过滤器腿侧向弹出。该封闭可以用从侧面开口的下端向上弯曲越过过滤器腿的管状内部的弯曲壁176形成。图16中的过滤器10示出为展开的形态,锚件144通过侧面开口174侧向布置。图17示出锚件部分展开,而图18示出锚件全部展开。
权利要求书
(按照条约第19条的修改)
1.一种医疗设备锚件及置放系统,其用于推动一个或多个锚件通过血管壁从第一内侧到第二外侧,包括:
血块过滤器其具有中央纵轴并可向所述纵轴折叠成折叠形态并可展开成从所述纵轴向外展开的形态以与所述血管壁的内侧接触,所述血块过滤器具有多个细长腿其每个具有近端和在远端终止的远端部,所述细长腿的近端固定到一起邻近所述血块过滤器的纵轴,所述细长腿形成为从所述纵轴向外延伸出去以使得至少其远端部的一部分在所述血块过滤器的展开形态中与血管壁的第一内侧接触,
一个或多个所述细长腿其具有敞开近端,出口开口形成在所述腿中的远端部,内部通道在所述敞开近端和所述出口开口之间延伸,
一个或多个锚杆其具有相对的第一和第二端,一第二末端部在所述第二端终止,
在每个所述锚杆的第二端的可展开锚件其具有一个或多个锚件部分,所述可展开锚件具有所述锚件与所述锚杆基本同向延伸的第一形态,以及所述一个或多个锚件部分从所述锚杆向外展开的第二展开形态,
锚杆其安装以在所述一个或多个细长腿的内部通道中的纵向移动,而可展开锚件以折叠形态邻近所述出口开口,当可展开锚件在折叠形态邻近出口开口时,每个所述锚杆的第一端从所述细长腿的近端向外展开,及
驱动单元包括安装用于朝向所述细长腿的近端的纵向移动以接合所述一个或多个锚杆的第一端而将每个锚杆纵向移向所述一个或多个细长腿的远端,以将每个可展开锚件通过出口开口推出并穿过血管壁的驱动杆。
2.如权利要求1所述的医疗设备锚件及置放系统,其中每个所述可展开的锚件包括一个或多个锚件部分,其在所述可展开锚件被从管状细长腿的出口开口中推出并通过血管壁时从所述锚杆向外展开并形成环回从上方越过所述锚杆,所述可展开锚件取向使得由所述一个或多个锚件部分之一形成的环压靠在所述血管壁上并响应将所述环拉向所述血管壁的力而改变形态形成更小的环。
3.如权利要求1所述的医疗设备锚件及置放系统,其中每个所述可展开锚件包括一个或多个锚件部分,其在所述可展开锚件被从管状细长腿的出口开口中推出并通过血管壁时从所述锚杆向外展开并形成环回从下方越过所述锚杆。
4.如权利要求1所述的医疗设备锚件及置放系统,其中包括连接到每个细长锚杆的第一端的杆支撑毂,当所述一个或多个在第一折叠情况下的可展开锚件包含在所述细长腿的内部通道中时所述杆支撑毂与所述细长腿的近端隔开,所述杆支撑毂可朝向所述细长腿的近端移动以使所述锚杆轴向移动以将可展开锚件推出所述细长腿的出口开口并通过血管壁,所述驱动轴具有第一驱动轴端其与所述杆支撑毂接合以使所述杆支撑毂相对所述细长腿的近端移动。
5.如权利要求4所述的医疗设备锚件及置放系统,其中所述驱动轴安装用于在具有邻近所述杆支撑毂隔开的内端的细长的过滤器中心杆内移动,所述过滤器中心杆具有多个长的间隔的一端固定到所述中心杆内端的中心臂,所述中心臂适于向外展开而与所述血管壁内侧接合。
6.如权利要求5所述的医疗设备锚件及置放系统,其中所述驱动轴包括与所述第一驱动轴端相对的第二驱动轴端,所述第二驱动轴端连接到推进装置以使所述驱动轴将所述杆支撑毂推向所述细长腿的近端。
7.如权利要求1所述的医疗设备锚件及置放系统,其中一个或多个所述细长并间隔的腿具有相对所述敞开近端的闭合远端,以及对内部通道的形成在腿的远端部分的作为所述出口开口的侧面开口,所述侧面开口与所述每个细长腿的闭合远端隔开。
8.如权利要求7所述的医疗设备锚件及置放系统,其中所述侧面开口具有与所述各细长腿的远端隔开的下缘,细长腿具有从与侧面开口的下缘相对并在其上方的位置到侧面开口的下缘延伸越过所述内部通道的内部弯曲导壁,在每个锚杆朝向细长腿的远端纵向移动时,所述弯曲导壁起作用以接合及引导所述锚件通过侧面开口出去。
9.如权利要求1所述的血块过滤器及置放系统,其中包括锁定单元其与细长腿的近端接合以使细长腿相对所述一个或多个锚杆的纵向移动被锁定。
10.如权利要求9所述的医疗设备锚件及置放系统,其中所述一个或多个细长腿连接到其近端的保持套管,所述锁定单元啮合所述保持套管以使所述一个或多个细长腿相对所述一个或多个锚杆的纵向移动被锁定。
11.如权利要求10所述的医疗设备锚件及置放系统,其中所述锁定单元包括用于啮合所述保持套管的可释放锁。
12.如权利要求11所述的医疗设备锚件及置放系统,其中安装所述驱动轴以纵向移动以使所述杆支撑毂移向所述保持套管以使所述一个或多个锚杆移向所述一个或多个细长腿的远端而将每个可展开锚件通过出口开口推出并通过血管壁。
13.如权利要求12所述的医疗设备锚件及置放系统,其中所述驱动轴包括安装以接合所述第一驱动轴的第二驱动轴,所述第二驱动轴连接到一推进单元,其可被操作以纵向推动所述第二驱动轴而将所述驱动轴和杆支撑毂推向保持套管。
14.如权利要求13所述的医疗设备锚件及置放系统,其中所述锁定单元包括长的过滤器中心杆其在其内端具有用于啮合保持套管的可释放锁,所述长的过滤器中心杆的可释放锁与保持套管啮合以允许过滤器中心杆将血块过滤器移入到血管内并在所述一个或多个锚杆朝向细长腿的远端纵向移动期间在一个或多个细长腿的纵向移动期间防止所述一个或多个细长腿的纵向移动,安装所述驱动轴用于在所述过滤器中心杆内纵向移动。
15.如权利要求4所述的医疗设备锚件及置放系统,其中当所述一个或多个锚件在细长腿内处于折叠状态时所述杆支撑毂与细长腿的近端隔开足够的距离以使在所述杆毂移动到邻近细长腿的近端时所述可展开锚件和每个锚杆的所述第二端部被通过出口开口推出并通过血管壁到其第二侧。
16.如权利要求15所述的医疗设备锚件及置放系统,其中在所述可展开锚件的第二展开形态中,所述一个或多个锚件部分从每个所述锚杆的第二端向外弓形弯曲并朝向所述锚杆的第二端部弯回。
17.如权利要求1所述的医疗设备锚件及置放系统,其中每个所述可展开锚件形成为从锚杆的第二端侧向展开并在至少两个分开的位置接合血管的外表面。
18.如权利要求1所述的医疗设备锚件及置放系统,其中所述出口开口形成在细长腿的远端。
19.如权利要求7所述的医疗设备锚件及置放系统,其中每个所述出口开口具有与细长腿的远端上方隔开的下缘,每个所述细长腿具有一内部弯曲导壁其从相对并在所述出口开口的下缘的上方的位置延伸到所述出口开口的所述下缘,在所述锚杆纵向移向细长腿的远端时所述弯曲导壁工作以接合并引导所述锚件从出口开口出来
20.如权利要求1所述的医疗设备锚件及置放系统,其中设置了从一个或多个细长腿的远端向外延伸的突起以在所述远端部接触所述内表面时穿透血管壁的内侧以在每个可展开锚件被弹出通过出口开口和血管壁时防止所述细长腿引起的纵向移动。
Claims (18)
1.一种医疗设备锚件及置放系统,其用于推动锚件通过血管壁从第一侧到第二侧其中所述锚件在所述第二侧上展开,包括:
具有第一和第二相对端的锚杆,
在所述锚杆的第二端上的具有一个或多个锚件部分的可展开锚件,所述可展开锚件具有第一折叠形态其中锚件与锚杆基本同向延伸,以及第二展开形态其中所述一个或多个锚件部分从锚杆向外延伸,
细长管其具有敞开的近端和带有出口开口的远端,该出口开口用于锚件形成在所述管中位于或邻近于但与所述远端隔开,所述管包括具有以折叠形态邻近所述出口开口的可展开锚件的所述锚杆,及
驱动单元其安装以接合锚杆的第一端及
将锚杆纵向移向细长管的第二端以将可展开锚件从所述出口开口向外推。
2.如权利要求1所述的医疗设备锚件及置放系统,其中在锚杆的第二端的可展开锚件通过在第二端纵向裂开锚杆而形成第一和第二锚件部分而与锚杆整体形成。
3.如权利要求1所述的医疗设备锚件及置放系统,其中在可展开锚件的第二展开形态,所述一个或多个锚件部分从锚杆向外弓形延伸并形成环回越过并延伸超过锚杆而形成闭合环。
4.如权利要求1所述的医疗设备锚件及置放系统,其中所述管的远端是封闭的,出口开口形成为在所述管中的隔开在所述封闭远端之上的侧面开口,锚杆被驱动单元驱动产生的纵向移动将锚件侧向推出管的出口开口。
5.如权利要求4所述的医疗设备锚件及置放系统,其中出口开口具有与所述管的远端隔开的下缘,所述管具有从与所述出口开口的下缘相对并在其上方的位置到所述出口开口的下缘延伸的内部弯曲导壁,在所述锚杆朝向管的远端纵向移动时,所述弯曲导壁起作用以接合及引导所述锚件通过所述出口开口出去。
6.如权利要求1所述的医疗设备锚件及置放系统,其中锚杆的近端连接到杆支撑毂,所述驱动单元包括驱动轴其具有与杆支撑毂接合的第一端,并可操作为在被推动时使杆支撑毂将细长管的锚杆纵向移动以将可展开锚件从管的出口开口向外推出。
7.如权利要求6所述的医疗设备锚件及置放系统,其中驱动轴包括与第一端相对的第二端,所述第二端连接到一推进单元其可被操作而推动驱动轴。
8.如权利要求7所述的医疗设备锚件及置放系统,其中细长管的近端连接到管保持套管,当所述可展开锚件在细长管内处于所述折叠形态时,锚杆从细长管的近端向外延伸到与管保持套管隔开的杆支撑毂,
所述驱动轴可在被驱动时操作将杆支撑毂移向管保持套管。
9.如权利要求8所述的医疗设备锚件及置放系统,其中在可展开锚件的第二展开形态,所述一个或多个锚件部分从锚杆向外弯曲并弯回而从下方越过锚杆。
10.如权利要求9所述的医疗设备锚件及置放系统,其中所述可展开锚件由热形状记忆材料形成,该材料具有温度转变水平其中在低于所述温度转变水平的温度下所述形状记忆材料柔软可压缩而在至少等于或大于所述温度转变水平的温度下所述形状记忆材料为自动展开的成为大致坚硬的预定形态。
11.如权利要求1所述的医疗设备锚件及置放系统,其中所述管形成血块过滤器的一个或多个腿以推动一个或多个锚件通过血管壁从第一内侧到第二外侧,血块过滤器具有中心纵轴并可被朝向所述纵轴折叠成折叠形态及从所述纵轴向外展开成展开形态以与血管壁的内侧接触,
所述血块过滤器包括多个长的隔开的腿其每一个具有远端和近端,每个细长腿被一起固定到邻近血块过滤器的纵轴,在所述血块过滤器的展开形态,所述多个长的隔开的腿形成为从所述纵轴向外延伸以使其远端与血管的第一内侧接触,
一个或多个所述长的隔开的腿形状为管状并由包含所述长的锚杆和所述可展开锚件的所述管形成,所述一个或多个管状细长腿其每个包含在第一折叠状态的邻近其远端的所述可展开锚件,及
杆支撑毂连接到每个长的锚杆的第一端,当位于第一折叠状态的可展开锚件被包含在所述管状细长腿中时所述杆支撑毂与细长腿的近端隔开,所述杆支撑毂可移向所述细长腿的近端以纵向移动锚杆而将所述可展开锚件从所述管状细长腿的出口开口推出并通过血管壁。
12.如权利要求11所述的医疗设备锚件及置放系统,其中每个所述可展开锚件包括一个或多个锚件部分,在所述可展开锚件被从管状细长腿的出口开口推出并通过血管壁时其从锚杆向外延伸并形成环回从上方越过所述锚杆,所述可展开锚件取向为使得一个或多个锚件部分之一形成的环被抵靠在血管壁上压缩并响应将环拉向血管壁的力而改变形态形成更小的环。
13.如权利要求11所述的医疗设备锚件及置放系统,其中每个所述可展开锚件包括一个或多个锚件部分,在所述可展开锚件被从管状细长腿的出口开口推出并通过血管壁时其从锚杆向外延伸并形成环回从下方越过锚杆。
14.如权利要求11所述的医疗设备锚件及置放系统,其中包括驱动轴,其具有连接到所述杆支撑毂以使杆支撑毂相对细长腿的近端移动的第一驱动轴。
15.如权利要求14所述的医疗设备锚件及置放系统,其中所述驱动轴安装用于在具有邻近所述杆支撑毂隔开的内端的长的过滤器中心杆内移动,所述过滤器中心杆具有多个长的间隔的一端固定到所述中心杆内端的中心臂,所述中心臂适于向外展开而与所述血管壁内侧接合。
16.如权利要求15所述的医疗设备锚件及置放系统,其中所述驱动轴包括与所述第一驱动轴端相对的第二驱动轴端,所述第二驱动轴端连接到推进装置以使所述驱动轴将所述杆支撑毂推向所述细长腿的近端。
17.如权利要求11所述的医疗设备锚件及置放系统,其中一个或多个所述细长并间隔的腿具有敞开的近端、从敞开近端延伸的内部通道、相对所述敞开近端的闭合远端,以及对内部通道的形成在腿的侧面部分在所述闭合远端上方的作为所述出口开口的侧面开口,
及杆推进单元其用于啮合杆支撑毂以将长的锚杆纵向移向所述一个或多个细长腿的闭合远端以将可展开锚件推出所述一个或多个细长腿的侧面开口并通过血管壁。
18.如权利要求17所述的医疗设备锚件及置放系统,其中所述侧面开口具有与所述各细长腿的远端隔开的下缘,细长腿具有从与侧面开口的下缘相对并在其上方的位置到侧面开口的下缘延伸越过所述内部通道的内部弯曲导壁,在每个锚杆朝向细长腿的远端纵向移动时,所述弯曲导壁起作用以接合及引导所述锚件通过侧面开口出去。
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CN111513662A (zh) * | 2014-03-31 | 2020-08-11 | 捷锐士股份有限公司 | 用于腔内装置的锚固机构和系统 |
CN104055601A (zh) * | 2014-07-07 | 2014-09-24 | 宁波健世生物科技有限公司 | 一种新型的植入器械释放装置 |
US10485909B2 (en) | 2014-10-31 | 2019-11-26 | Thoratec Corporation | Apical connectors and instruments for use in a heart wall |
CN113229992A (zh) * | 2016-04-28 | 2021-08-10 | 深圳市科奕顿生物医疗科技有限公司 | 一种下腔静脉滤器 |
CN113229992B (zh) * | 2016-04-28 | 2023-07-21 | 深圳市科奕顿生物医疗科技有限公司 | 一种下腔静脉滤器 |
US10894116B2 (en) | 2016-08-22 | 2021-01-19 | Tc1 Llc | Heart pump cuff |
US11583671B2 (en) | 2016-08-22 | 2023-02-21 | Tc1 Llc | Heart pump cuff |
US11235137B2 (en) | 2017-02-24 | 2022-02-01 | Tc1 Llc | Minimally invasive methods and devices for ventricular assist device implantation |
CN108969030A (zh) * | 2017-06-02 | 2018-12-11 | 上海微创医疗器械(集团)有限公司 | 医疗装置 |
CN108969030B (zh) * | 2017-06-02 | 2022-01-07 | 上海佐心医疗科技有限公司 | 医疗装置 |
Also Published As
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US9283065B2 (en) | 2016-03-15 |
US8398672B2 (en) | 2013-03-19 |
US7056286B2 (en) | 2006-06-06 |
US20050131451A1 (en) | 2005-06-16 |
US20100076545A1 (en) | 2010-03-25 |
US8409239B2 (en) | 2013-04-02 |
US20130218195A1 (en) | 2013-08-22 |
US20050101982A1 (en) | 2005-05-12 |
US20100222772A1 (en) | 2010-09-02 |
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