CN1278713A - 栓塞预防装置 - Google Patents
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Abstract
一种栓塞预防装置包含一个可收缩滤芯(105),其安装在一个滤芯载体,如导丝(101)上。滤芯(105)可以收缩到一个导管(118)的外端中,以展开和回收于患者血管系统中。滤芯(105)包含一个带有近侧进入端和远侧排出瑞的可收缩过滤体。近侧进入端带有进入口,它们的尺寸允许血液和栓塞物质进入过滤体。排出端带有排出口,它们允许血液通过但会将不希望的栓塞物质限制在过滤体中。在使用之后,导管(118)可以沿导丝(101)移动,以咬合滤芯的近端并封闭进入口,接着会从近端至远端在滤芯上滑动,从而逐渐将过滤体压缩在导丝(101)上以便回收。滤芯(105)可以方便地安装在一个管状套筒(105)上,套筒可以在位于导丝(101)上的相隔挡块(106,120)之间沿着导丝(101)滑动和旋转,从而在滤芯使用时能够对导丝进行一些独立操作。
Description
介绍
本发明涉及一种栓塞预防装置。
术语“中风”用于描述一种医学现象,其使得供应到脑部或脑部特定区域中的血液受限或阻塞到这样的程度,即不能充分地提供维持功能所需的氧合血液流动。脑部将被临时或永久损伤,而患者将失去某些功能,例如,视觉、语言或四肢的控制能力。中风有两种截然不同的类型,即出血性和栓塞性中风。本发明涉及栓塞性中风。
医学文献中认为颈动脉疾病是栓塞物质的只要产生源。通常,会有动脉粥样硬化斑块形成在颈动脉中。斑块的性质差别很大,但在大多数情况下,斑块可以裂开并流向血管远侧,从而阻塞流向脑部特定区域的血流并导致神经性损伤。这种疾病的传统治疗方法是外科颈动脉内模切除术,即切开颈动脉并将斑块从血管中物理去除。这种方法被广泛接受,因为据文献称神经性并发症比例低,有的文献称该比例为6%左右,尽管声称该比例可以有很大变化。
不是所有患者均适宜接受手术。有很多原因可能导致患者不能承受手术介入。这样的患者以及越来越多的实施手术的患者将接受一种贯穿导管方法的治疗。在这种情况下,该方法采用某些装置插入股动脉中并控制装置到达狭窄部位。一个气囊原生质导管将膨胀以张开动脉,而且有时需要在狭窄部位采用一个血管内扩张器。这些装置的作用同手术一样,可以使栓塞物质移出,而这种物质将随动脉血流动,并且如果增长到足够大,最终将阻塞血管并导致中风。
现已知道,可以在人的血管系统中永久性植入一个过滤器以收集栓塞物质。还知道,为此可以使用可换过滤器。这种可换过滤器通常包括伞式过滤器,在伞式过滤器中,一个过滤膜被支撑在一个可收缩架上,该架位于一根导丝上,后者用于带动过滤膜在一个顶靠着导丝的收缩位置与一个封闭血管的横向伸展位置之间运动。这种过滤器的例子见于US 4723549、US 5053008、US5108419和WO 98/33442中。各种展开和/或收缩装置可以用于伞式过滤器中。然而,当过滤器收缩时,所俘获的栓塞物质容易被向外挤压到过滤器的一个开口端,而栓塞物质块将从过滤器中逃脱,从而有可能导致灾难性后果。更常见的情况是,在从一个导管或类似物中移出之前,过滤伞就已经收缩了。同样,在过滤膜收缩时,将导致栓塞物质被挤出。此外,伞式过滤器通过要被固定在导丝上,而导丝在介入过程中的任何偶然动作都可能导致过滤器移位。
本发明的目的是克服这些问题。
因此,需要有一种栓塞预防装置,以克服这些问题。
本发明概述
根据本发明,提供了一种栓塞预防装置,其包含:
一个可收缩滤芯,其安装在一个用于输送通过患者血管系统的滤芯载体上,
滤芯可以在一个用于移动通过血管系统的顶靠着滤芯载体的收缩储存位置与一个用于阻塞血管系统以使流过血管的血液输送通过滤芯的扩张位置之间移动,
其特征在于,滤芯包含一个可收缩过滤体,其带有一个进入端和一个排出端,
过滤体的进入端具有一个或多个进入口,它们的尺寸允许血液和栓塞物质进入过滤体,
过滤体的排出端具有一组排出口,它们的尺寸允许血液通过但会将不希望的栓塞物质限制在过滤体中,以及
用于封闭位于过滤体进入端的进入口的装置。
有益的是,滤芯的进入口在滤芯被压缩之前封闭,从而将所有的栓塞物质限制在滤芯中。
在本发明的一个特别优选的实施例中,用于封闭进入口的装置包含:
一个管状滤芯回收装置,其具有一个用于接收滤芯的敞开远端,
上述远端可以与过滤体的一个近侧进入端咬合以封闭进入口,并能够在过滤体上从进入端向排出端滑动,以使过滤体逐渐收缩在滤芯载体上并将过滤体接收于回收装置中。
方便的是,回收装置可以是一个导管或罩等,其在咬合和压缩滤芯时首先会封闭进入口,以防止任何栓塞物质逃逸,之后再从近端开始向着滤芯远端滑过滤芯,从而压缩滤芯的其余部分。
在本发明的一个特别优选的实施例中,可收缩滤芯在一对位于滤芯载体上的相隔挡块之间以可滑动的方式安装在滤芯载体上,以使滤芯能够沿滤芯载体在所述挡块之间移动。
有益的是,滤芯载体可以是,例如,一个导丝,其可以相对于滤芯独立移动,从而在,例如,更换医用装置时允许导丝的偶然动作,而又不会意外移动滤芯。
在一个附加实施例中,滤芯以可旋转的方式安装在滤芯载体上。
在一个优选实施例中,一个套筒在所述挡块之间以可滑动的方式安装在滤芯载体上,套筒的长度小于所述挡块之间的距离,滤芯元件安装在套筒上。
在一个特别优选实施例中,滤芯包含:
一个可收缩滤网,其安装在滤芯载体上,
滤网可以在一个顶靠着滤芯载体的收缩位置与一个从滤芯载体向外伸展以横贯血管展开的扩张位置之间移动。
优选的是,管状滤芯回收装置包含一个导管,其可以沿滤芯载体滑动,导管的一个敞开远端形成一个用于接收滤芯的壳。
在另一个实施例中,过滤体的一个近侧进入端固定在滤芯载体上,而过滤体的一个远端以可滑动的方式安装在滤芯载体上,当然也可以相反安置。
在一个附加实施例中,过滤体的远端固定在一个可以沿滤芯载体滑动的套环上。
在一个优选实施例中,一个滤芯支撑构架安装在滤芯载体上,该支撑构架可以在一个沿着滤芯载体的收缩位置与一个用于将过滤体支撑在扩张位置的向外凸出位置之间移动。
在另一个实施例中,滤芯支撑构架在过滤体的一个近端固定在滤芯载体上。
优选的是,滤芯支撑构架在过滤体的一个远端以可滑动的方式咬合着滤芯载体。理想的是,滤芯支撑构架被推向一个常规伸展位置。
在一个附加实施例中,过滤体上带有一个圆周槽,其位于过滤体的所述端部之间。
在另一个实施例中,一个橄榄形导向件在过滤体的远侧装于滤芯载体上,橄榄形导向件具有一个圆筒形本体和一个锥形远端,圆筒形本体咬合在一个展开导管的远端中,上述锥形远端从展开导管向外伸出,从而在导管与滤芯载体之间提供光滑过渡。
在一个附加实施例中,网在其每端均汇聚在滤芯载体中。
在本发明的另一个实施例中,提供了一种栓塞预防装置,其包含一个用于安置在所需位置上的滤芯,滤芯带有一个血液通道并带有装置以俘获、限制和取出不希望有的栓塞物质。
在本发明的一个实施例中,通道中带有限流装置以俘获不希望有的栓塞物质。
在本发明的另一个实施例中,滤芯带有一个近端和一个远端,近端的开口大于远端的开口,近端开口的尺寸允许血液和栓塞进入滤芯,而远端开口的尺寸允许血液通过,但会将不希望有的栓塞物质俘获在滤芯中。
在本发明的又一个实施例中,滤芯包含储存装置,以储存滤芯中俘获的不希望有的栓塞物质。优选的是,储存装置包含位于滤芯中的附加储存通道。优选的是,滤芯确定了一个三维矩阵。
在本发明的另一个实施例中,滤芯由一个聚合物多孔结构构成。在本发明的又一个实施例中,矩阵包含一个多孔结构,该结构具有这样的尺寸,从而能够收集尺寸在100微米至3500微米范围内的栓塞物质。在本发明的又一个实施例中,滤芯是可压缩和/或可折叠的,从而可以被装载到一个输送装置中,以将滤芯以压缩或折叠状态输送到一个所需位置。
在本发明的一个实施例中,滤芯中的材料被从结构中去除,以有助于提高压缩率。
在本发明的另一个实施例中,滤芯中的材料被从结构中去除,从而根据所需俘获的栓塞物质的尺寸而提供出特定的尺寸。
在本发明的又一个实施例中,滤芯中带有穿过滤体的通道,它们是相互连通的,以适应于流过滤芯的流率的要求。
在本发明的另一个实施例中,滤芯具有一个锥形远端,以使横向刚度光滑过渡,从而提高滤芯在血管系统中的灵活性。
在本发明的又一个实施例中,滤芯具有一个柔软的远端,以有助于在血管系统中无损伤输送。优选的是,滤芯具有一个圆周槽,以降低滤芯的横向柔性。
在本发明的一个实施例中,滤芯具有一个锥形近端,以便于被一个取出导管回收。
在本发明的另一个实施例中,滤芯具有进入口,它们在被拉入一个取出导管时会被封闭,从而确保限制住收集的栓塞。
在本发明的又一个实施例中,滤芯具有排出口,它们具有这样的尺寸,即能够俘获尺寸大到足以损伤用于接收滤芯下游血液的组织的功能的栓塞物质。优选的是,滤芯的尺寸使之可以俘获尺寸大于100微米的栓塞物质。最优选的是,滤芯的尺寸使之可以俘获尺寸大于200微米的栓塞物质。最优选的是,滤芯的尺寸使之可以俘获尺寸大于500微米的栓塞物质。
在本发明的一个实施例中,滤芯的尺寸使之能够完全覆盖在血管的横截面上,并允许血液和血液成分通过。
在本发明的又一个实施例中,提供了一种装置,其包含有用于安装在一个医用导丝上的装置。
在本发明的另一个实施例中,提供了一种装置,其可以被安置在一个气囊或扩张输送导管下面。
在本发明的又一个实施例中,提供了一种装置,其包含有利用贯穿导管方法穿过股动脉、臂动脉、桡骨动脉、锁骨下动脉或其它动脉穿孔的装置。
在本发明的一个实施例中,提供了一种装置,其能够在手术介入过程中保护手术切口部位及其附近的神经功能。
可以预计,可以将两个装置双向用于左右颈动脉中,从而在凝块产生可能性高的过程中,例如冠状心率失常的电生理治疗中,保证充足的脑血流,以维持神经功能。
在本发明的又一个实施例中,提供了一种装置,其包含一个输送导管,其中一个外套可以与滤芯或滤芯载体咬合以在输送过程中提供推力,从而在介入过程中使得血管横截面空间最大化。
在本发明的一个实施例中,外套通过一个接合装置连接在滤芯或滤芯载体上。接合装置可以是一个可拆除缩口管或可拆除卡箍。优选的是,接合装置是一个压缩接头,如Tuohy Borst连接器。
在本发明的另一个实施例中,输送导管在其至少部分长度上带有一个中央孔腔,以使之能够沿一个可控导丝运行。
在本发明的又一个实施例中,外套足够长以伸展到血管系统之外,并且能够向近侧移动以将滤芯从导管中释放出来。
在本发明的一个实施例中,输送导管带有一个外罩,其伸展超出推力元件,从而构成一个滤芯限制套筒。
在本发明的另一个实施例中,输送导管中包含一个弹簧部件,其具有一个局部阶进增大的节距,以改变刚度特性,从而适应于目标血管系统。
在本发明的又一个实施例中,输送导管中包含一个弹簧部件,其具有一个局部逐渐增大的节距,以改变刚度特性,从而适应于目标血管系统。
在本发明的一个实施例中,滤芯安装在一个可收缩支撑构架上,该构架可以在一个用于部署的收缩位置与一个伸展的使用位置之间移动,装有装置以将支撑构架限制在收缩位置。优选的是,支撑构架包含支撑臂。优选的是,支撑臂由一种形状记忆或弹性记忆材料制成。最优选的是,支撑臂由镍钛诺制成。
在本发明的一个实施例中,支撑臂被这样构造,即它们从滤芯载体上同轴张开,从而可以通过将滤芯向近侧拉入一个适宜尺寸的外套中而限制并取出它们。
在本发明的另一个实施例中,滤芯带有一个相关的支撑构架,其具有一个预成形螺旋结构,从而使之可以向滤芯提供径向支撑。
在本发明的又一个实施例中,在被拉入一个回收导管时,滤芯支撑构架可以折叠至一个收缩位置。
在本发明的一个实施例中,滤芯包含一个柔性的成形聚合物部件。
在本发明的另一个实施例中,成形聚合物部件被这样构造,从而使得流过该部件的流体有助于使部件从收缩位置张开。
在本发明的又一个实施例中,成形聚合物部件是柔性的并利用排出滤芯表面的两侧压差而张开,从而与血管壁发生圆周接触。
在本发明的又一个实施例中,滤芯安装在一个导丝上,从而使得导丝具有相对于滤芯独立的旋转和/或轴向移动自由度。更优选的是,导丝具有相对于滤芯完全独立的旋转自由度,但轴向运动被限制。轴向运动的限制是通过安装和连接在导丝上的挡块实现的。理想的是,导丝可以相对于滤芯独立地轴向移动100mm。更理想的是,导丝可以相对于滤芯独立移动100mm以下。本实施例便于在更换导管时保持滤芯的位置并能够相对于滤芯独立地操纵导丝。
在本发明的又一个实施例中,滤芯的近端连接在滤芯载体上,而其远端可以相对于滤芯载体和近端自由移动,从而有助于使滤芯收缩以便部署。
在本发明的又一个实施例中,滤芯在部分或整个长度具有锥形,因而能够在其某些长度部分上精确地适合于血管尺寸。
在本发明的又一个实施例中,成形聚合物部件包含一个或多个沿其本体布置的圆周槽,以使滤芯在过小尺寸动脉中保持环形形状。
在本发明的一个实施例中,滤芯直接连接在一个可控医用导丝上,导丝上装有一个可以通过移动而展开滤芯的可滑动套。
在本发明的另一个实施例中,提供了一种装置,其采用了一个医用导丝,导丝上带有一个位于滤芯远侧的柔性段,以使导丝具有可操作性,特别是在展开之前。
在本发明的又一个实施例中,提供了一种装置,其采用了一个医用导丝,导丝上带有一个柔软的远侧段,从而提供出一个无损伤末端部分。
在本发明的又一个实施例中,提供了一种装置,其包含一个位于滤芯远端上的多孔涂层,其带有通过滑动运动打开和关闭滤芯的装置。
在本发明的一个实施例中,滤芯的近端为锥形,从而使之能够向近侧拉入外套中以便取出,这种拉出动作将有效地减小滤芯直径并有助于回收。
在本发明的另一个实施例中,滤芯包含一个多孔结构,其可以通过滑动运动展开和关闭,其通过紧配合在一个凸缘上而实现的关闭可以导致支撑元件向近侧拉动,从而利用所附着的过滤薄膜而封闭该结构。
在本发明的又一个实施例中,提供了一种装置,其包含一个滤芯,该滤芯允许一个医用导丝装于滤芯外壁之内或附近,以便于在滤芯的近侧进入端带有大的进入口。
在本发明的一个实施例中,滤芯包含一个具有大的近侧进入口和小的远侧排出口的网结构,其中网结构可以收缩到一个小径输送导管中并可以通过展开而膨胀至一个被网结构通过形状记忆特性或弹性记忆特性而记忆的形状。
在本发明的另一个实施例中,滤芯包含一个网结构,其中滤芯在血管中的扩张可以使滤芯咬合血管壁并与血管内孔的形状一致,从而导致流过血管的血液可以流过滤芯。
在另一个实施例中,滤芯包含一个编织纤维网。优选的是,远侧排出口由一组交织纤维所包围的区域确定出来。大的近侧进入口通过编织物中的纤维汇聚成安装在滤芯载体上的少量几束而构成。优选的是,纤维网材料是一种弹簧或形状记忆材料,从而使之可以收缩到一个输送导管中并随着展开而回复其扩大形状。网中的纤维在它们彼此交叉的点处连接起来。纤维可以由一种聚合物或金属或一种复合材料制成。
在又一个实施例中,滤芯的远端能够沿轴向相对于滤芯近端移动,从而占据血管的准确形状。
在又一个实施例中,装置包含一个位于滤芯远端上的多孔涂层,其带有通过滑动运动打开和关闭滤芯的装置。优选的是,滤芯包含一个由一组丝构成的可收缩丝构架,所述丝的外面端部铰接安装在滤芯载体上,丝的端部是间接铰接的,丝的一端固定在滤芯载体上,而丝的另一端安装在一个可以沿滤芯载体滑动的套环上,一个多孔滤网安装在丝构架上。一个操纵套筒可以在滤芯载体上滑动,以将套环推向滤芯的固定端,而一个收缩装置可以与套环咬合,以将套环从滤芯的固定端上拉回,从而使丝构架收缩顶靠在滤芯载体上,以回收滤芯。
在本发明的又一个实施例中,提供了一种滤芯回收系统,其包含一个轴向导管,该导管具有一个可变形末端,以有助于将滤芯拉入导管。
在本发明的另一个实施例中,提供了一种系统,其包含一个滤芯、一个输送导管和一个回收导管,用以在介入过程中临时过滤血管系统。
根据本发明的另一个方面,提供了一种栓塞预防装置,其包含:
一个可收缩滤芯,其安装在一个用于输送通过患者血管系统的滤芯载体上,
滤芯可以在一个用于移动通过血管系统的顶靠着滤芯载体的收缩储存位置与一个用于阻塞血管系统以使流过血管的血液输送通过滤芯的扩张位置之间移动,一对相隔的挡块位于滤芯载体上,可收缩滤芯以可滑动的方式安装在滤芯载体上,从而可以在挡块之间沿滤芯载体轴向移动,以及用于将滤芯收缩在滤芯载体上的装置。
附图简述
通过下面仅以示例形式所作的说明并参考附图,可以更清除地理解本发明,附图包括:
图1是根据本发明的一个栓塞预防装置在使用时的侧视图;
图2是图1所示装置在预加载位置以备插入时的侧视图;
图3a是一种用于将装置固定在导管上的方法的侧视图;
图3b是采用图3a所示固定方法的栓塞预防装置的侧视图;
图4是另一种固定方法的侧视图;
图5是图4所示固定方法中所用的一个双瓣套环的端视图;
图6是另一种固定方法的侧视图;
图7是图6所示固定方法中所用的一个小型卡箍的端视图;
图8是本发明的装置中所用的一个滤芯的侧视图;
图9是另一个滤芯的侧视图;
图10是图8所示滤芯被取出时的侧视图;
图11是另一个滤芯在使用时的就位形状的等角轴测图;
图12是图11所示滤芯在收缩位置以备插入和抽出时的侧视图;
图13至15是另一个滤芯在不同位置时的侧视图;
图16和17是另一个带掀钮配合回收结构的滤芯的一部分的侧视图;
图18是另一个栓塞预防装置安装在血管中时的局部横截面透视图;
图19a至19c是图18中所用滤芯支撑的成形过程透视图;
图20至22是另一个滤芯的透视图;
图23是另一个滤芯的立视图;
图24是沿图23中的线ⅩⅩⅣ-ⅩⅩⅣ的剖面图;
图25是沿图23中的线ⅩⅩⅤ-ⅩⅩⅤ的剖面图;
图26是滤芯的一部分的放大视图;
图27是图23所示滤芯的展开图;
图28是一种方法的侧视图,其中用于附着滤芯的基管可以在基本横贯导丝上移动;
图29是用于显示位置的侧视图,其中安装了“橄榄形”部件,以在基本横贯导丝与加载罩之间形成光滑过渡;
图30是滤芯处于最远端位置时的透视图;
图31是滤芯处于最近端位置时的透视图;
图32是滤芯的透视图,其中滤芯远端不粘着在基管上;
图33是一个手风琴形滤芯的侧视图;在图33a中滤芯展开,而在图33b中滤芯处于加载形状;
图34是浮动远端的透视图,其中一个弹簧元件装于浮动远端的远侧;
图35是浮动远端的侧视图,其中一个弹簧装在浮动远端中;
图36是浮动远端结构的侧视图,其中形状记忆合金从近端伸展到远端;
图37是采用了浮动远端的网结构的透视图;
图38是多种滤芯几何形状的透视图;
图39中显示了一个纤维网滤芯结构,其中纤维在远端编织并汇聚成多个位于近端的纤维束;
图40是根据本发明的一个栓塞预防装置的局部剖切立视图;
图41是图40所示栓塞预防装置的示意性剖切立视图;以及
图42是图40所示装置的一部分的详细剖面图。
详细说明
请参考各附图,它们显示了根据本发明的各种栓塞预防装置。总体上讲,这些装置中均包含一个滤芯,其在手术或介入过程中通常通过导丝和导管而被临时放置在一个所需位置上。滤芯提供了一个血液通道,并带有工具以俘获和保持手术过程中释放出来的不希望有的栓塞物质。当介入过程结束之后,容纳着栓塞物质的滤芯被取出。通过这种方式,可以防止因手术过程中不希望有的栓塞物质的释放而导致患者出现中风或其它并发症。
在装置的一个实施例中,采用了跨丝贯穿导管结构。临床医师将一个可控导丝穿过损伤的器官区域。之后,栓塞预防装置被穿在导丝上并远程放置到被治疗的部位处。通过操作或其它途径,滤芯被展开在血管中并收集在气囊膨胀和扩张器放置过程中产生或移出的栓塞。
首先请参考图1和2,在本例中滤芯由一个可压缩多孔结构聚合泡沫滤芯1构成,其嵌套模塑或接合在一个聚合物或金属管或弹簧或其它空心支撑元件2上。泡沫滤芯1被压缩到一个位于导管6远端的壳或罩3中,以便被推进到所需位置。一旦就位之后,罩3将后退或滤芯1被推进。这个动作将导致压缩滤芯1膨胀到所需尺寸并阻塞住血管4,只留下滤芯1中提供的一个或多个通道。滤芯1被这样设计,即提供出一个或多个通道,用以使血细胞和其它血液成分通过,但能够俘获尺寸大于滤芯孔尺寸的栓塞。通过滤芯的形成,可以保持血液流率,以使滤芯两侧的局部压降最小化。滤芯1具有一个近侧进入端7和一个远侧排出端8。进入端7带有一组进入口,它们的尺寸允许血液和栓塞进入滤芯。排出端8带有一组排出口,它们的尺寸允许血液通过,但会将不希望有的栓塞物质限制在滤芯1的本体中。
在本例中,滤芯1由多孔结构或聚合泡沫制成,这种泡沫具有开口腔结构且通常密度小于每立方米400公斤。优选的是,密度小于每立方米100公斤,理想的是小于每立方米50公斤。通过适宜地构造泡沫体的孔尺寸或附加去除材料,可以产生具有适宜尺寸的血液流通通道和俘获大尺寸栓塞的途径,从而获得过滤能力。在后文中将描述多种可以单独或同时实现滤芯1的尺寸和流率特性的结构。滤芯1的操作和展开可以通过滤芯1与覆盖壳3之间的相对运动而实现。
在操作过程中不希望导管相对于支撑元件2移动。可以通过多种不同方式将内部支撑元件2固定在导管6上,从而防止上述运动。在描述的实施例中,这种固定是通过一个导管6罩盖着支撑元件2和滤芯1而实现的。如图3A和3B所示,这种固定是这样实现的,即一个收缩卷绕管5通过收缩而捕获了罩盖导管6和支撑元件2。一旦滤芯1到达理想位置,则通过一个剥离环7而将收缩卷绕接头打开,以使外侧导管6随后移出,并使支撑元件2和滤芯1就位。
可以采用多种其它可操作结构以将支撑元件2和导管6连接起来。可以使用一个双瓣套环结构10(图4和5),其可以通过松开一个或多个螺钉或诸如小型卡箍11(图6和7)等可以松开的结构而被卸下,以释放开各部件之间的连接。
另一种可以用于将内部支撑元件2临时固定在外套或导管6上的方法是采用止血高压Touhy Borst Y连接器。利用这种市场有售的连接器,医生可以在插入动脉之前冲洗外套。外套或导管可以永久性连接在连接器上。内部管状支撑元件2穿过连接器的Touhy Borst段,并因此而穿过外套中心。拧紧Touhy Borst段将导致这种夹持松开,以使内部管状支撑元件2和外部外套在此彼此相对移动。
图8中显示了滤芯1的一种典型实施例,其中一个泡沫基体的过滤体中通过去除材料而产生了一组路径或通道20,它们能够使血液流过但能够限制住栓塞物质并防止栓塞物质通过滤芯。通道20可以通过各种方法加工出来,例如,采用激元、YAG(钇铝柘榴石)、CO2或其它激光类型的激光切割,冻结和加工或失蜡加工。多种尺寸形式可以满足需要。在图示结构中,进入口优选具有0.5mm或以上的尺寸,以俘获大的栓塞,而排出口则小于300微米。可以根据不同尺寸血管中的不同流体介质中所需过滤的不同尺寸的颗粒而容易地改变上述尺寸。
过滤介质可以通过任何现有技术连接在基管上,例如通过机械接合、溶解或粘接,并嵌套模塑在一个结构中,即基管被放置在模具中,之后,聚合材料被注射到模具中,从而在基管与聚合物元件之间的界面处连接起来。此外,泡沫或多孔元件可以基础或粘接在一个基管上。
应当指出,滤芯1具有一个圆形远端21,以便于插入,而近端22则为锥形的,以便于抽出。或者,如图9所示,远端21也可以是锥形的。
特别请参考图10,在介入过程结束后,可以将一个大孔导管25推进到滤芯1的近端22并将滤芯1拉入导管25中,从而将装置抽出。当起始锥体被拉入导管25而过滤体的其它部分在缩扁之前,滤芯1会压缩并封闭滤芯近端进入口。一旦滤芯1被完全抽入导管25中,即可以从患者体内去除。滤芯1中容纳着俘获的栓塞。
在图11至15中所示的本发明的另一个实施例中,一个被薄膜或多孔织物或网31覆盖着的辐条结构30可以被叠合入一个输送外套或罩中,以便随后在目标血管中展开。本结构中包含一个基轴33,其上沿径向或圆周方向连接着一组预成形丝30。丝30在近端汇聚成一个安装在基轴33上的可移动环或管32,而在远端汇聚成一个固定管34。管32可以移近和移远到一定程度,从而将组件以类似于伞的方式打开和封闭,以阻塞血管。辐条30可以由金属、聚合或合成材料制成。构架上覆盖着多孔材料31,多孔材料的孔尺寸被选择,以使介质能够通过,从而有效地形成一个滤膜。可以通过将一种材料,如聚氨脂或PET注塑在预成形丝上,从而将覆盖织物31连接在构架30上。之后,薄膜被lazed或通过其它方法,如机械或加热冲孔或化学蚀刻而制成多孔结构。此外,也可以在聚合物基质中加入可溶颗粒,之后再去除这些颗粒以使聚合物多孔。通过调节颗粒在聚合物基质中的比率和分布,可以控制孔隙度。
当组件被构造为轴向形状后,一个外套或罩可以在组件上滑动以覆盖组件。与前面实施例中相同,加载后的导管是通过穿在导丝上而被放置在所需位置上的。一旦到达了所需位置,外套可以向后移动,以使组件暴露在血管中。之后,一个套筒35可以向前移动以张开或展开组件。通过构造相对尺寸和选择材料可以使得套筒35不会在内管上滑动,除非施加外力以使之移动。在展开后,装置将保持张开并捕捉流向脑部的栓塞。在过程结束后,一个沿内管进给的预成形部件将与可移动管32对接,以使后者移向装置的近端,从而导致结构被封闭。之后,一个较大外套可以单独地进给到滤芯位置,而滤芯可以被拉入或被操纵着向近侧进入外套。在被抽入外套或管中后,装置可以沿着导丝或与导丝一起被取出。
请参考图16和17,图中显示了另一种栓塞预防装置。在本例中,滤芯的基本结构是一个连接在基管上的成形薄膜部件。在实际应用中,有很多种形状可以采用。当约束力去除之后,一个处于预成形形状的元件将张开成为一个构架40,其连接在一个基管41上。构架元件40可以由各种金属或聚合材料制成,例如,诸如镍钛诺等形状记忆合金或形状记忆聚合物或具有类似性能的成形不锈钢或金属,从而可以从变形状态充分恢复原形,以导致薄膜部件张开。否则的话,也可以通过机械运动或操作以使装置张开。成形薄膜部件连接在构架40周围。薄膜部件可以通过多种现有的工业技术成形。这些技术包括吹塑、浸渍模塑、溶解模塑、旋转模塑、薄膜接头以及粘接剂粘接。薄膜部件的目标是制造出一个成形形状并能够在血管中张开到一定尺寸和形状以阻塞血管。通过在元件的远端和近端产生一个点阵或组的孔,可以获得过滤能力,以使栓塞和血液能够进入装置,但远端较小的孔则允许血液通过而到达远侧血管,同时又限制住了栓塞。
在被输送到所需位置时,滤芯被一个外套覆盖或限制着。通过抽回外套或进给滤芯,可以使滤芯露出并张开以阻塞血管。在随后的过程中,滤芯能够俘获试图流向远侧的栓塞。在过程结束后,一个外套前进到装置的近端,而滤芯则带着俘获的栓塞而被向近侧拉入外套中。在这种结构中,栓塞可以容易地取出,以便随后分析。
前面所描述的本发明涉及的是一种套在导丝上使用的装置。幸运的是,本发明可以以这样的方式构造,即其自身可以被用作基本横贯装置。所有上述滤芯结构均可以安装在导丝或下面所述的横贯装置上。对于基本横贯装置,滤芯可以连接在一个实心基体上。由于不需要在另一个工具上移动,因此滤芯的缠绕内径可以较小,从而带轮某些益处。图18中显示了有关差异。滤芯1安装在一个基轴33上。一个可收缩滤芯支撑元件50在滤芯1的近端安装在基轴33上。支撑元件50带有多个可折叠臂51,它们在收缩时顶靠着轴33,并在释放后展开时向外伸展以使滤芯1在血管中扩张。
请参考图20至22,图中显示了滤芯的一种替换性结构,所示的一个处于扩张位置的可压缩滤芯1带有一个大的进入口60和若干小的排出口61。一个可收缩丝支承62装于滤芯1的近端。丝支承62可以带着滤芯1收缩在一个壳或罩中,并在释放后展开以将滤芯1支撑在血管4中。
图23至27中显示了一种替换性滤芯结构,在本例中,滤芯包含一个镍钛诺网,其可以从图23所示的收缩位置展开到图27所示的扩张位置,从而提供出一个带近端入口66和远端出口67的过滤体65。
对于基本横贯装置,装置的远端应是柔性和无损伤的。这可以通过多种途径实现,例如,制作一个弹性或聚合物元件,其具有足够的柔性从而能够在接触到血管内壁时偏转。末端部分被安装在滤芯的远端。装置的一个中央部分套着滤芯1,滤芯在展开之前一直被覆盖着。一个外套可以具有装置的全长,或者也可以利用一个致动器连接着只套着滤芯的短外套。装置的近侧部分带有气囊膨胀和扩张装置的工作台。图示中的获得工作台的方法是去除近端盖子以暴露出一个丝或弹性组件。或者,整个近端部分可以用作一个工作台。基本上讲,在用作气囊导管和扩张器时,装置应这样构造尺寸,即它的外径尺寸能够使得导管在其上自由移动。冠状制品的普通工业标准允许装置在0.014”或0.018”的直径上自由移动,而外围原生质制品采用0.035”外径。
请参考图28,连接着滤芯的基管33可以在两个挡块63与64之间移动,所示挡块安装在基本横贯导丝2上。挡块可以由各种金属或聚合材料制成,以使基管33能够在它们之间移动。在实际医用导丝中,挡块还可以采用台阶的形式。在这种应用例子中,挡块63与64之间的距离可以有很大变化。挡块的尺寸可以防止基管相对于它们移动,从而用作基管的近侧位置和远侧位置挡块。挡块可以通过多种现有工业技术安装在基本横贯导丝上;这些技术包括低温焊接、焊接、braising、碾压和粘接剂粘接。近端挡块的尺寸应足够小,以便能够装配在输送导管的内轴中。滤芯可以相对于导丝独立地轴向移动和旋转。这样可以获得良好的导丝运动和滤芯位置控制。在更换导管时,滤芯位置保持不变。可以采用任何现在有售的导丝以实施本技术。
图29中涉及一个“橄榄形”部件65;该橄榄形部件可以由各种金属或聚合材料制成,例如聚合泡沫、塑料、不锈钢或金属。橄榄形部件可以在导丝2与加载了滤芯的罩3之间形成光滑过渡,并使得滤芯容易在罩中定位。橄榄形部件可以直接连接在导丝上,或者也可以连接在一个基管33上。橄榄形部件可以通过各种现有技术,如粘接剂粘接和低温焊接而连接到导丝或基管上。橄榄形部件可以根据需要在一定范围的距离内移动到滤芯远端。橄榄形部件可以具有多种形状和尺寸。
图30中涉及处于最远侧位置时的滤芯1。滤芯在加载过程中或展开之后可以到达这个位置。挡块元件64可以防止滤芯1向远侧移动超出它。
图31中显示了处于最近侧位置时的滤芯,滤芯在装置展开过程中或展开之后可以到达这个位置。挡块元件63可以防止滤芯1向近侧移动超出它。
图32中涉及一种浮动远端,在本例中,一个挡块部件66邻近于滤芯的远端。滤芯的最远端固定在一个标记圈70或其它适宜的基体上。标记圈70不固定在基管33上。这使得滤芯远端能够沿轴向自由移动超出挡块部件。挡块部件可以采用任何适宜的形状或形式,以防止滤芯的远端向近侧移动超出挡块部件的固定点。挡块部件可以由金属或聚合材料制成,其可以通过各种现有技术,包括粘接剂粘接和低温焊接,而连接在基管33上。挡块部件66可以工作在50与70之间的任何位置上。由于滤芯可以沿轴向伸展并缠绕在较大长度上,因此滤芯的浮动远端有助于将滤芯加载到加载罩。这将使所需的加载力降低,同时又减小了加载滤芯的轮廓。浮动远端结构方便了大范围滤芯结构的加载。
图33中涉及一种带浮动远端的手风琴形滤芯。这种滤芯形状提高了滤芯的周边整体性,从而可以防止滤芯沿长度方向出现褶皱。图33a中滤芯处于展开就位状态。图33b中显示了滤芯被加载到一个加载罩中后其远端沿轴向伸展的情况。浮动远端结构适合于加载多种形状的滤芯结构。对于所示滤芯结构,在加载时需要采用一个长套以容纳滤芯增加了的轴向长度。
图34中涉及添加了弹簧元件67的浮动远端。弹簧安置在滤芯的远侧。如前面图33中所示,在加载后浮动远端沿轴向伸展,弹簧在滤芯展开时用作一个安全装置,以确保浮动远端能够返回初始位置。弹簧元件足够软,以使远端能够在加载时沿远侧方向自由伸展,但又足够硬,从而能够在展开后将远端推回初始位置。弹簧元件可以由聚合物或金属材料制成。弹簧元件可以安装在一个基体33上,而且一个挡块元件用于防止弹簧向远侧轴向移动。也可以采用其它方法,例如粘接、焊接、碾压、低温焊接,以保持弹簧元件的远端静止,或者也可以将弹簧远端碾压在基体33上。这种技术也可以通过将弹簧制成实际导丝的一部分而实现。还有其它装有回复弹簧元件的结构,如图35和36中所示。
在图35中,弹簧元件67在其近端连接在基体33上,而滤芯的远端连接着弹簧轴。这种结构使得滤芯的远端能够向远侧伸展。伸展长度可以由一个挡块68的定位或弹簧刚度确定。当外力从滤芯上撤除之后,弹簧将推动滤芯返回初始位置。在图36中,一种形状记忆合金,例如镍钛诺,用于使滤芯返回初始位置。镍钛诺支撑构架69以其远端70固定在基体33上,且其近端71是浮动的。镍钛诺的形状记忆性能将确保滤芯返回初始位置。这种结构便于使用其它市场有售或已知的形状记忆合金。这种结构也可以通过弹簧部件实现。
在图37中也采用了浮动远端结构。如前面在图27中所示的过滤体65安装在一个基体33上。扩张器的近端固定在基体上而浮动远端结构使得过滤体65能够向远侧伸展。当远侧伸展时,其外径会减小而总体长度增大。可以带有也可以不带一个挡块68,因为过滤体65最多伸展到其自身的弹性极限,该极限是由过滤体的尺寸和几何形状确定的。在外力撤除之后,过滤体的形状记忆功将导致过滤体返回初始位置。过滤体65的近端可以通过现有技术,如粘接、低温焊接或碾压而固定在基体上。
图38中显示了可以用在栓塞预防装置中的多种滤芯结构。在滤芯过大时,这些滤芯结构可以减小褶皱的轴向长度,从而用作褶皱破坏器。图示滤芯的每个端部均可以用作滤芯的远端和近端。过滤体可以是筒形的或截头圆锥形的。
请参考图40至42,图中显示了一个根据本发明的栓塞预防装置,其总体上以参考代号100表示。装置100中包含一个导丝101,其具有一个近端102和一个远端103。一个管状套筒104以可滑动的方式安装在导丝101上。一个可收缩滤芯105安装在套筒104上,该滤芯105可以在一个顶靠着套筒104的收缩储存位置与图中所示的从套筒104向外伸展以阻塞血管的扩张位置之间移动。
套筒104可以在导丝101上在一对相隔的端部挡块之间滑动,这一对挡块包括一个内挡块106和一个外挡块,在本例中外挡块由位于导101远端103处的弹簧末端107构成。
滤芯105中包含一个网110,其安装在一个可收缩支撑构架111上。网110的每端均收集在套筒104中,网110刚性连接着套筒104的一个近端112,而且网110还连接在一个可以沿着套筒104的远端114滑动的套环115上。这样,网110的远端可以沿着套筒104轴向滑动。支撑构架111也固定在套筒104的近端112上。支撑构架111的一个远端116不固定在套筒104上,因而可以以沿着套筒104轴向滑动,以便于使支撑构架111收缩顶靠在套筒104上。支撑构架111可以如图所示自然展开,也可以向内收缩顶靠在套筒104上,以装载到一个导管118或类似物中。
滤芯105带有大的近侧进入口117和小的远侧排出口119。近侧进入口117使得血液和栓塞物质能够进入过滤体中,而远侧排出口119允许血液通过但能够将不希望有的栓塞物质限制在过滤体中。
一个橄榄形导向件120安装在套筒104的远端处并具有一个圆筒形中央部分121和锥形端部122和123。远端122可以具有一个箭头形状,以使导管与橄榄形表面光滑过渡。支撑构架111被这样成形,即在滤网110上带有一个圆周槽125。如果滤芯相对于血管来说过大,则网可能出现褶皱,而该槽125可以确保不会有任何褶皱沿滤芯扩展。
在滤网110的近端带有扩大开口,以使血液和栓塞能够进入网110内部。
在使用时,滤芯105在收缩状态下安装在导管118的远端中并被输送到一个展开位置。当滤芯被蒸汽就位后,导管118后退,以使支撑构架111展开,从而使网110横贯安置着滤芯的血管。血液和栓塞可以进入滤网110的近端扩大开口。血液可以通过网壁,而网的开口或孔的尺寸使之可以限制住栓塞。在使用之后,导管沿导管101传输并首先滑过与近侧进入端112咬合着的滤芯105以封闭各开口,之后,随着导管118在滤芯105上前进,又逐渐使网收缩顶靠在套筒104上。一旦滤芯105被完全装载到导管118中,即可以被抽出。
应当指出,滤芯的一个近端是固定的,而滤芯的一个远端可以沿套筒轴向移动,从而便于收缩滤网。
此外,导管首先咬合滤网的近端,从而可以封闭滤网进入口,以防止滤网在收缩过程中栓塞物质从滤网中逃逸。
方便的是,构成滤芯的接收壳或罩的导管的末端可以由弹性材料制成,其可以径向扩展以容纳俘获了栓塞物质的滤芯。通过适宜地选择材料,同一个导管或罩可以用于展开或收缩滤芯。在展开时,弹性材料在一个缩紧位置上保持着滤芯,以使导管末端或罩的尺寸最小化。之后,在收缩滤芯时,导管末端或罩充分地弹性变形,以容纳因栓塞物质造成的滤芯的额外体积。
此外,滤芯并不紧固在导丝上,因此,例如,在更换医疗装置或替换导管时,导丝的偶然动作不会导致滤芯的意外移动。
还应当指出,根据本发明的滤芯不象很多伞式过滤器那样带有锋利的外棱边。相反,滤芯的普通管状形状更容易被血管内壁接纳。
方便的是,当滤芯在血管中展开时,导管可以取出,从而留下一个与滤芯邻近的裸露导丝,从而可以与诸如导管等现有装置和位于滤芯上游的扩张装置一起使用。
Claims (77)
1.一种栓塞预防装置,其包含:
一个可收缩滤芯,其安装在一个用于输送通过患者血管系统的滤芯载体上,
该滤芯可以在一个用于移动通过血管系统的顶靠着滤芯载体的收缩储存位置与一个用于阻塞血管系统以使流过血管的血液输送通过滤芯的扩张位置之间移动,
其特征在于,滤芯包含一个可收缩过滤体,其带有一个进入端和一个排出端,
过滤体的进入端具有一个或多个进入口,它们的尺寸允许血液和栓塞物质进入过滤体,
过滤体的排出端具有一组排出口,它们的尺寸允许血液通过但会将不希望的栓塞物质限制在过滤体中,以及
用于封闭位于过滤体进入端的进入口的装置。
2.根据权利要求1所述的装置,其特征在于,所述用于封闭进入口的装置包含:
一个管状滤芯回收装置,其具有一个用于接收滤芯的敞开远端,
上述远端可以与过滤体的一个近侧进入端咬合以封闭进入口,并能够在过滤体上从进入端向排出端滑动,以使过滤体逐渐收缩在滤芯载体上并将过滤体接收于回收装置中。
3.根据权利要求1或2所述的装置,其特征在于,可收缩滤芯在一对位于滤芯载体上的相隔挡块之间以可滑动的方式安装在滤芯载体上,以使滤芯能够沿滤芯载体在所述挡块之间移动。
4.根据权利要求3所述的装置,其特征在于,滤芯以可旋转的方式安装在滤芯载体上。
5.根据权利要求3或4所述的装置,其特征在于,一个套筒在所述挡块之间以可滑动的方式安装在滤芯载体上,套筒的长度小于所述挡块之间的距离,滤芯元件安装在套筒上。
6.根据前面任一权利要求所述的装置,其特征在于,滤芯包含:
一个可收缩滤网,其安装在滤芯载体上,
滤网可以在一个顶靠着滤芯载体的收缩位置与一个从滤芯载体向外伸展以横贯血管展开的扩张位置之间移动。
7.根据权利要求2至6之任一项所述的装置,其特征在于,管状滤芯回收装置包含一个导管,其可以沿滤芯载体滑动,导管的一个敞开远端形成一个用于接收滤芯的壳。
8.根据前面任一权利要求所述的装置,其特征在于,过滤体的一个近侧进入端固定在滤芯载体上,而过滤体的一个远端以可滑动的方式安装在滤芯载体上。
9.根据权利要求8所述的装置,其特征在于,过滤体的远端固定在一个可以沿滤芯载体滑动的套环上。
10.根据权利要求5至9之任一项所述的装置,其特征在于,一个滤芯支撑构架安装在滤芯载体上,该支撑构架可以在一个沿着滤芯载体的收缩位置与一个用于将过滤体支撑在扩张位置的向外凸出位置之间移动。
11.根据权利要求10所述的装置,其特征在于,滤芯支撑构架在过滤体的一个近端固定在滤芯载体上。
12.根据权利要求10或11所述的装置,其特征在于,滤芯支撑构架在过滤体的一个远端以可滑动的方式咬合着滤芯载体。
13.根据权利要求10至12之任一项所述的装置,其特征在于,滤芯支撑构架被推向一个常规伸展位置。
14.根据权利要求10至13之任一项所述的装置,其特征在于,过滤体上带有一个圆周槽,其位于过滤体的所述端部之间。
15.根据前面任一权利要求所述的装置,其特征在于,一个橄榄形导向件在过滤体的远侧装于滤芯载体上,橄榄形导向件具有一个圆筒形本体和一个锥形远端,圆筒形本体咬合在一个展开导管的远端中,上述锥形远端从展开导管向外伸出,从而在导管与滤芯载体之间提供光滑过渡。
16.根据权利要求6至15之任一项所述的装置,其特征在于,网在其每端均汇聚在滤芯载体中。
17.根据前面任一权利要求所述的装置,其特征在于,滤芯包含储存装置,以储存滤芯中俘获的不希望有的栓塞物质。
18.根据权利要求17所述的装置,其特征在于,储存装置包含位于滤芯中的附加储存通道。
19.根据前面任一权利要求所述的装置,其特征在于,滤芯确定了一个三维矩阵。
20.根据权利要求19所述的装置,其特征在于,滤芯由一个聚合物多孔结构构成。
21.根据权利要求19或20所述的装置,其特征在于,矩阵包含一个多孔结构,该结构具有这样的尺寸,从而能够收集尺寸在100微米至3500微米范围内的栓塞物质。
22.根据前面任一权利要求所述的装置,其特征在于,滤芯是可压缩和/或可折叠的,从而可以被装载到一个输送装置中,以将滤芯以压缩或折叠状态输送到一个所需位置。
23.根据前面任一权利要求所述的装置,其特征在于,滤芯中有材料被从结构中去除,以有助于提高压缩率。
24.根据前面任一权利要求所述的装置,其特征在于,滤芯中有材料被从结构中去除,从而根据所需俘获的栓塞物质的尺寸而提供出特定的尺寸。
25.根据前面任一权利要求所述的装置,其特征在于,滤芯中带有穿过滤体的通道,它们是相互连通的,以适应于流过滤芯的流率的要求。
26.根据前面任一权利要求所述的装置,其特征在于,滤芯具有一个锥形远端,以使横向刚度光滑过渡,从而提高滤芯在血管系统中的灵活性。
27.根据前面任一权利要求所述的装置,其特征在于,滤芯具有一个柔软的远端,以有助于在血管系统中无损伤输送。
28.根据前面任一权利要求所述的装置,其特征在于,滤芯具有一个圆周槽,以降低滤芯的横向柔性。
29.根据前面任一权利要求所述的装置,其特征在于,滤芯具有一个锥形近端,以便于被一个取出导管回收。
30.根据前面任一权利要求所述的装置,其特征在于,滤芯具有进入口,它们在被拉入一个取出导管时会被封闭,从而确保限制住收集的栓塞。
31.根据前面任一权利要求所述的装置,其特征在于,滤芯具有排出口,它们具有这样的尺寸,从而能够俘获尺寸大到足以损伤用于接收滤芯下游血液的组织的功能的栓塞物质。
32.根据权利要求31所述的装置,其特征在于,滤芯的尺寸使之可以俘获尺寸大于100微米的栓塞物质。
33.根据权利要求31所述的装置,其特征在于,滤芯的尺寸使之可以俘获尺寸大于200微米的栓塞物质。
34.根据权利要求31所述的装置,其特征在于,滤芯的尺寸使之可以俘获尺寸大于500微米的栓塞物质。
35.根据前面任一权利要求所述的装置,包含用于将装置安置在一个医用导丝上的装置。
36.根据权利要求35所述的装置,可以被安置在一个气囊或扩张输送导管下面。
37.根据前面任一权利要求所述的装置,包含有利用贯穿导管方法穿过股动脉、臂动脉、桡骨动脉、锁骨下动脉或其它动脉穿孔的装置。
38.根据前面任一权利要求所述的装置,包含一个输送导管,其中一个外套可以与滤芯或滤芯载体咬合,以在输送过程中提供推力,从而在介入过程中使得血管横截面的空间最大化。
39.根据权利要求38所述的装置,其特征在于,外套通过一个接合装置连接在滤芯或滤芯载体上。
40.根据权利要求39所述的装置,其特征在于,接合装置是一个可拆除缩口管。
41.根据权利要求39所述的装置,其特征在于,接合装置是一个可拆除双瓣套环。
42.根据权利要求39所述的装置,其特征在于,接合装置是一个可拆除卡箍。
43.根据权利要求39所述的装置,其特征在于,接合装置是一个压缩接头。
44.根据权利要求43所述的装置,其特征在于,压缩接头是一个Tuohy Borst连接器。
45.根据权利要求38至44之任一项所述的装置,其特征在于,输送导管在其至少部分长度上带有一个中央孔腔,以使之能够沿一个可控导丝运行。
46.根据权利要求38至45之任一项所述的装置,其特征在于,外套足够长以伸展到血管系统之外,并且能够向近侧移动以将滤芯从导管中释放出来。
47.根据权利要求38至46之任一项所述的装置,其特征在于,输送导管带有一个外罩,其伸展超出推力元件,从而构成一个滤芯限制套筒。
48.根据前面任一权利要求所述的装置,其特征在于,输送导管中包含一个弹簧部件,其具有一个局部阶进增大的节距,以改变刚度特性,从而适应于目标血管系统。
49.根据前面任一权利要求所述的装置,其特征在于,输送导管中包含一个弹簧部件,其具有一个局部逐渐增大的节距,以改变刚度特性,从而适应于目标血管系统。
50.根据前面任一权利要求所述的装置,其特征在于,滤芯安装在一个可收缩支撑构架上,该构架可以在一个用于部署的收缩位置与一个伸展的使用位置之间移动,装有装置以将支撑构架限制在收缩位置。
51.根据权利要求50所述的装置,其特征在于,支撑构架包含支撑臂。
52.根据权利要求51所述的装置,其特征在于,支撑臂由一种形状记忆或弹性记忆材料制成。
53.根据权利要求52所述的装置,其特征在于,支撑臂由镍钛诺制成。
54.根据权利要求51所述的装置,其特征在于,支撑臂被这样构造,即它们从滤芯载体上同轴张开,从而可以通过将滤芯向近侧拉入一个适宜尺寸的外套中而限制并取出它们。
55.根据前面任一权利要求所述的装置,其特征在于,滤芯带有一个相关的支撑构架,其具有一个预成形螺旋结构,从而使之可以向滤芯提供径向支撑。
56.根据前面任一权利要求所述的装置,其特征在于,在被拉入一个回收导管时,滤芯支撑构架可以折叠至一个收缩位置。
57.根据前面任一权利要求所述的装置,其特征在于,滤芯包含一个柔性的成形聚合物部件。
58.根据权利要求57所述的装置,其特征在于,成形聚合物部件被这样构造,从而使得流过该部件的流体有助于使部件从收缩位置张开。
59.根据前面任一权利要求所述的装置,其特征在于,成形聚合物部件是柔性的并利用排出滤芯表面的两侧压差而张开,从而与血管壁发生圆周接触。
60.根据前面任一权利要求所述的装置,其特征在于,滤芯直接连接在一个可控医用导丝上,导丝上装有一个可以通过移动而展开滤芯的可滑动套。
61.根据前面任一权利要求所述的装置,采用了一个医用导丝,导丝上带有一个位于滤芯远侧的柔性段,以使导丝具有可操作性,特别是在展开之前。
62.根据前面任一权利要求所述的装置,采用了一个医用导丝,导丝上带有一个柔软的远侧段,从而提供出一个无损伤末端部分。
63.根据前面任一权利要求所述的装置,包含一个滤芯,其允许一个医用导丝装于滤芯外壁之内或附近,以便于在滤芯的近侧进入端带有大的进入口。
64.根据前面任一权利要求所述的装置,其特征在于,滤芯包含一个具有大的近侧进入口和小的远侧排出口的网结构,其中网结构可以收缩到一个小径输送导管中并可以通过展开而膨胀至一个被网结构通过形状记忆特性或弹性记忆特性而记忆的形状。
65.根据前面任一权利要求所述的装置,其特征在于,滤芯包含一个网结构,其中滤芯在血管中的扩张可以使滤芯咬合血管壁并与血管内孔的形状一致,从而导致流过血管的血液可以流过滤芯。
66.根据前面任一权利要求所述的装置,其特征在于,滤芯包含一个编织纤维网。
67.根据权利要求66所述的装置,其特征在于,远侧排出口由一组交织纤维所包围的区域确定出来。
68.根据权利要求66或67所述的装置,其特征在于,大的近侧进入口通过编织物中的纤维汇聚成安装在滤芯载体上的少量几束而构成。
69.根据权利要求66至68所述的装置,其特征在于,纤维网材料是一种弹簧或形状记忆材料,从而使之可以收缩到一个输送导管中并随着展开而回复其扩大形状。
70.根据权利要求66至69所述的装置,其特征在于,网中的纤维在它们彼此交叉的点处连接起来。
71.根据权利要求66至70所述的装置,其特征在于,纤维由一种聚合物或金属或一种复合材料制成。
72.根据前面任一权利要求所述的装置,其特征在于,滤芯的远端能够沿轴向相对于滤芯的近端移动,从而占据血管的准确形状。
73.根据前面任一权利要求所述的装置,包含一个位于滤芯远端上的多孔涂层,其带有通过滑动运动打开和关闭滤芯的装置。
74.根据权利要求73所述的装置,其特征在于,滤芯包含一个由一组丝构成的可收缩丝构架,所述丝的外面端部铰接安装在滤芯载体上,丝的端部是间接铰接的,丝的一端固定在滤芯载体上,而丝的另一端安装在一个可以沿滤芯载体滑动的套环上,一个多孔滤网安装在丝构架上。
75.根据权利要求74所述的装置,其特征在于,一个操纵套筒可以在滤芯载体上滑动,以将套环推向滤芯的固定端,而一个收缩装置可以与套环咬合,以将套环从滤芯的固定端上拉回,从而使丝构架收缩顶靠在滤芯载体上,以回收滤芯。
76.用于与根据前面任一权利要求所述装置一起使用的滤芯回收系统,其包含一个轴向导管,该导管具有一个可变形末端,以有助于将滤芯拉入导管。
77.一种用于在介入过程中将栓塞材料从血管中复合并取出的方法,其包含以下步骤:
准备一个栓塞预防装置,其包含一个具有近端和远端的导丝,一个可收缩滤芯邻近于导丝的远端安装,滤芯可以在一个顶靠着导丝的收缩储存位置与一个从导丝横向向外伸展的扩张位置之间移动,
将一个导管沿导丝滑动并从滤芯的一个近侧进入端覆盖滤芯,以将滤芯收缩并容纳在导管的一个远端中,
将导管的远端插入患者的血管系统中,
将远端安置在血管系统中的一个所需位置,
保持住导丝并抽回导管,以将滤芯从导管中释放到扩张位置,
在介入过程中过滤血液,
在介入过程之后沿导丝进给一个回收导管并使之咬合滤芯的一个近侧进入端,
将滤芯压缩到导管的远端中,以及
将导管从患者体内抽出。
Applications Claiming Priority (4)
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IE970789 | 1997-11-07 | ||
IE970789 | 1997-11-07 | ||
IE980267 | 1998-04-08 | ||
IE980267 | 1998-04-08 |
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CN1278713A true CN1278713A (zh) | 2001-01-03 |
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Application Number | Title | Priority Date | Filing Date |
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CN98810901A Pending CN1278713A (zh) | 1997-11-07 | 1998-11-09 | 栓塞预防装置 |
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US (27) | US6336934B1 (zh) |
EP (2) | EP1752112B1 (zh) |
JP (2) | JP4328888B2 (zh) |
KR (1) | KR20010052095A (zh) |
CN (1) | CN1278713A (zh) |
AT (2) | ATE382309T1 (zh) |
AU (1) | AU9758398A (zh) |
BR (1) | BR9813935A (zh) |
CA (2) | CA2450927C (zh) |
DE (4) | DE69838952T2 (zh) |
ES (2) | ES2300124T3 (zh) |
GB (1) | GB2345253B (zh) |
IE (2) | IE980920A1 (zh) |
IL (1) | IL135463A0 (zh) |
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2007
- 2007-06-13 US US11/762,283 patent/US8221448B2/en not_active Expired - Fee Related
- 2007-06-13 US US11/762,440 patent/US8430901B2/en not_active Expired - Fee Related
- 2007-06-13 US US11/762,462 patent/US8226678B2/en not_active Expired - Fee Related
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2008
- 2008-12-17 US US12/336,572 patent/US20090099593A1/en not_active Abandoned
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2009
- 2009-02-05 US US12/366,249 patent/US20090143814A1/en not_active Abandoned
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2011
- 2011-07-15 US US13/183,583 patent/US8852226B2/en not_active Expired - Fee Related
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