CN111971079B - 血管内血泵 - Google Patents
血管内血泵 Download PDFInfo
- Publication number
- CN111971079B CN111971079B CN201980021509.5A CN201980021509A CN111971079B CN 111971079 B CN111971079 B CN 111971079B CN 201980021509 A CN201980021509 A CN 201980021509A CN 111971079 B CN111971079 B CN 111971079B
- Authority
- CN
- China
- Prior art keywords
- slit
- blood pump
- intravascular blood
- shaft
- impeller
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
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Images
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Abstract
血管内血泵具有承载叶轮(34)的可旋转的轴(25)和具有开口(35)的壳体(20),轴延伸穿过开口(35),叶轮被定位在壳体外。轴和壳体具有形成周向缝隙的表面(25A、33A),周向缝隙具有在缝隙的长度的至少一部分上的不大于2μm的缝隙宽度,并且形成缝隙的表面中的至少一个由具有至少100W/mK的热导率的材料制造,具体地陶瓷材料,例如SiC。
Description
技术领域
本发明涉及血管内血泵,特别是可经皮插入的血泵,用于支持在人的或可选择地还有动物的身体中的血液循环。例如,血泵可以被设计为被经皮地插入股动脉中,并且被引导经过身体的血管系统,例如,以支持或代替心脏中的泵送动作。
背景技术
上文提到的类型的血泵例如从EP 0 961 621 B1获知,其具有驱动节段、附接至驱动节段的近端端部(其是驱动节段的更靠近医生的端部或驱动节段的“后端部”)并且具有延伸经过其的用于向驱动节段供应电力的线的导管、以及在驱动节段的远端端部被紧固的泵节段。驱动节段包括具有布置在其中的电动马达的马达壳体,其中电动马达的马达轴在远端从驱动节段突出出来并且进入泵节段中。泵节段进而包括管状的泵壳体,管状的泵壳体具有在其中旋转的叶轮,叶轮固定在马达轴的从马达壳体突出出来的端部上。马达轴被安装在马达壳体中、且在两个轴承中,两个轴承被最大限度地彼此分开以保证叶轮在泵壳体内的真实的、精确地居中心的引导。虽然径向滚珠轴承被用于在马达壳体的近端端部的轴承,但是叶轮侧轴承(其是最靠近血液的轴承)被构造作为由聚四氟乙烯制造的对于血液的轴密封,聚四氟乙烯具有高的硬度和低的摩擦系数,从而提供支撑并且同时防止血液经过这样的远端轴承进入马达壳体。此外,血液向马达壳体内的进入,通过清洗流体被传递经过马达壳体和叶轮侧轴密封轴承抵消。这在高于血液中存在的压力的清洗流体压力进行。
上文提到的血泵的改进在US 2015/0051436 A1中公开,并且在附于本文的图2中示出。在此,在马达壳体的远端端部的叶轮侧轴承包括轴向滑动轴承和径向滑动轴承或组合的轴向径向滑动轴承,其中径向滑动轴承代替上文提到的轴密封轴承。据此,清洗流体流经叶轮侧径向滑动轴承的缝隙从而防止血液进入壳体中。
虽然本发明将被描述,并且优选地用于具有上文提到的具有被容纳在所述壳体中的马达的一类血管内血泵的上下文中,但是本发明同样有利地可适用于其他的类型的血管内血泵,其中马达在患者的身体外,用于叶轮的旋转能量借助于柔性的旋转驱动电缆被传递经过导管和被附接至导管的远端端部的所述壳体。此外,在这种类型的血管内血泵中,清洗流体通常流经驱动轴延伸穿过其中的开口进入患者的血液中。
典型地被混合入清洗流体中的肝素引起一个普遍的问题。即,尽管清洗流体流动经过在轴和壳体的开口之间形成的缝隙,由此将趋向于经过这样的缝隙进入壳体的血液推动返回,但是血液进入缝隙中不能够完全地被防止。特别是,一些血液可以始终至少进入这样的缝隙的远端节段中。肝素帮助防止血液在缝隙中凝结或血液粘附至表面,并且因此防止轴旋转的阻断。然而,医生往往不希望肝素被经过清洗流体给至患者的血液。例如,在急救期间,肝素可能适得其反,因为其防止血液的凝结,因此影响愈合或止血。此外,随清洗流体一起被给至患者的血液的肝素的量由于各种原因是难以控制的。特别是,肝素的量往往多于医生期望的量。据此,如果需要的话,医生将往往更愿意与血泵的操作相分开地将肝素以所需要的量供给患者。
据此,需要一种能够,如果期望的话,使用不含有或至少含有更少的肝素的清洗流体来运行的血管内血泵。
发明内容
因此,根据本发明的第一方面,血管内血泵可以包括承载叶轮的可旋转的轴和具有开口的壳体,其中轴延伸穿过开口,叶轮被定位在壳体外,轴和壳体具有形成在开口内的周向缝隙的表面。这与上文讨论的现有技术根本没有区别,并且所述缝隙可以特别构成用于轴的径向滑动轴承。然而,在本文公开的血泵中,缝隙的宽度在缝隙的长度的至少一部分上为2μm或更小,例如仅缝隙的前端或叶轮侧可以具有2μm或更小的缝隙宽度,或,在一个实施方式中,缝隙的宽度是沿着其整个长度为2μm或更小,并且,此外,两个形成周向缝隙的表面中的至少一个由具有热导率λ≥100W/mK的材料制造。
下文尝试解释为什么上文提到的措施对于在使用根本不含有肝素的清洗流体、甚至在临时时间内持续没有清洗流体的情况下能够被操作的血管内血泵有贡献。即,据认为,由于2μm或更小的小的缝隙宽度,具有近似地8μm的直径和近似地2μm的厚度的红血球难以进入和阻塞缝隙。此外,由于小的缝隙宽度,清洗流体以高速度流动经过缝隙,由此通过高动能将血液推动返回退出缝隙。然而,实验显示出,虽然看上去红血球被成功地防止进入缝隙中,但是生物材料在缝隙中聚集并且导致轴的阻断。据认为,尽管有强的清洗流体流,这种生物材料仍然来源于进入缝隙中的血浆。更具体地,据认为,沉积在缝隙中的生物材料主要地由附着至并且阻塞形成缝隙的表面的血浆的变性部分组成,特别是纤维蛋白。假设这是由在缝隙中产生的高的温度导致,由于很小的缝隙宽度,以及在缝隙中的由剪切引起的热量。另外的实验显示出,通过由具有相对高的热导率的材料制造表面,缝隙中的温度能够被保持为低水平,优选地在55℃或更低,由此防止血浆中的纤维蛋白的变性。
最出人意料地,已经发现,具有上文提到的特性的血管内血泵即使没有任何清洗流体移动穿过缝隙,也能工作持续更长的时间段而没有发生阻断。据认为,这能够归因于血浆进入缝隙并且在缝隙内的一个或更多个表面上形成滑的生物膜。这构成对于血管内血泵的实质性的安全因子,并且因此是对于这些泵极度地有益的。
具有100W/mK的热导率的形成缝隙的一个或更多个表面的材料可以足以将热量传导远离缝隙,并且因此将缝隙内的温度保持在55℃或更低。然而,热导率优选地是至少130W/mK,更优选地至少150W/mK,并且最优选地至少200W/mK。
为了将热量远离缝隙传递入血液中,优选的是所述形成缝隙的表面与流动经过泵的血流热传导接触。根据热力学,流动的血液比非流动的血液更快地带走热量。血液流动越快,越多的热量可以通过传导性的热传递被带走。经过泵的血流速度通常高于在泵外的血流速度。据此,例如,在缝隙中产生的、并且使形成缝隙的表面变热的热量可以被进一步地从轴的表面传导经过轴主体进入在轴的端部的叶轮中,并且从那里进入沿着叶轮流动的血液中。然而,因为用于热量在轴向方向流动经过轴主体、并且进一步地经过叶轮进入血液中的距离是相对长的,所以更优选的是将热量(另外地或仅)在径向方向,即经过形成缝隙的径向外表面,传导远离缝隙。将热量在径向方向带走是优选的,不但因为用于热量从缝隙流动至流动的血液的相对短的径向距离,而且因为,与热量可以被经过其在轴向方向传导的轴主体的热传导截面积相比,更容易增加热量可以被经过其在径向方向传导的热传导面积。即,轴主体的截面积A轴向是A轴向=πd2/4,并且形成缝隙的径向外表面的截面积A径向是A径向=πdl。因此,增加缝隙的直径(例如至d=1mm),对形成缝隙的径向外表面的截面积A径向的正面影响四倍高于对轴主体的截面积A轴向。此外,增加缝隙的长度(l)仅对形成缝隙的径向外表面的截面积A径向具有正面影响,对轴主体的截面积A轴向完全没有影响。在任何情况下,缝隙应该优选地是长的并且具有大的直径。然而,因为大的直径可以对抗在缝隙中产生的热量的量,所以缝隙的直径不应该太大(优选地d约≤1mm)。最优选地,形成缝隙的表面二者的热导率是高的,至少100W/mK,并且与血流热传导接触。
这样的热传导接触可以是直接的或间接的。直接的热传导接触能够被实现,如果形成缝隙的各个热传导表面构成结构元件的一部分,结构元件整个地由热传导材料制造,并且当血管内血泵在患者的血管中正在运行时与经过泵的血流直接接触。当轴和叶轮形成由一个热传导材料形成的一体部分时,和/或当壳体的形成用于轴通过的通孔的远端端部是由热传导材料制造的一体部分时,可以是这种情况。
可选择地,间接的热传导接触能够被实现,如果一个或更多个形成缝隙的表面分别地构成结构元件的一部分,该结构元件整个地由热传导材料制造,并且具有至少一个热传导地连接至分离的热传导元件的另外的表面,当血管内血泵在患者的血管中正在运行时,分离的热传导元件与流动的血液直接接触,或经过一个或更多个另外的热传导元件与流动的血液间接地热传导接触,使得来自一个或更多个形成缝隙的表面的热量能够通过热传导消散入流动的血液中。当然,热传导元件本身应该具有高的热导率,优选地高于一个或更多个形成缝隙的表面的优选的热导率,即高于100W/mK,优选地高于130W/mK,更优选地高于150W/mK,并且最优选地高于200W/mK。
因为形成缝隙的表面可以优选地构成用于轴的径向滑动轴承,所以表面应该具有非常小的表面粗糙度,优选地0.1μm或更小的表面粗糙度。虽然这样的表面粗糙度可以使用类金刚石碳覆层(DLC)被获得,如在US2015/0051436A1中作为用于轴的覆层提出的,但是使用当前的技术以这样的精度施用DLC覆层,在全缝隙的长度上,实现2μm或更小的缝隙宽度,是不可能的。因此优选的是由与DLC不同的材料,和/或通过不同的方法制造一个或更多个形成缝隙的表面,最优选地由陶瓷材料,特别是由烧结陶瓷元件。即,优选地,所述热传导表面不是结构元件上的覆层,而是一个或更多个结构元件的表面,即组装泵的一个或更多个元件的表面。
陶瓷的一个普遍的问题是陶瓷材料典型地具有非常低的热导率。例如,在US2015/0051436 A1中提到的氧化锆(ZrO2)具有仅2.5至3W/mK的热导率。氧化铝(Al2O3)是熟知的陶瓷,具有35至40W/mK的比较高的热导率,但是其仍然实质上低于金属例如铜的热导率。具有实质上较高的热导率的极少数的陶瓷的其中之一是碳化硅(SiC)。典型工艺的碳化硅具有在100W/mK和140W/mK之间的热导率,但是具有更高的热导率的碳化硅同样是可用的。纯的碳化硅具有350W/mK的热导率。与其他的陶瓷不同,碳化硅是非常脆性的并且因此难以操作。其可以在制造和组装期间容易地断裂。尽管如此,由于其良好的热容量,碳化硅对于本发明的目的对于形成缝隙的表面中的至少一个,优选地缝隙的径向外表面,是优选的材料,并且因为其脆性,对于轴不是优选的材料。因此,各个表面或形成这样的表面的整个结构元件包括碳化硅或优选地由碳化硅组成。
如果碳化硅形成滑动轴承的一个表面,那么滑动轴承的配合的相对的表面可以实质上具有任何其他的类型的材料,特别是任何其他的类型的陶瓷材料。用于各个其他的表面优选的陶瓷材料是氧化铝增韧氧化锆(ATZ),因为其的高的持久性,然而其具有仅25W/mK的热导率。因此优选的是由ATZ制造轴,并且由SiC制造轴在其中滑动(journal)的套筒,使得热量能够容易地从缝隙径向地向外地传导出进入流动的血液中。
因为从近端至远端流动穿过缝隙的清洗流体的压降由于小的缝隙宽度是高的,所以缝隙宽度优选地朝向缝隙的叶轮侧端部从宽至窄收缩(缝隙的叶轮侧端部是缝隙的接触到血液的侧部),使得仅缝隙的远端端部或相对短的远端节段具有2μm或更小的缝隙宽度。即,朝向缝隙的前端或叶轮侧端部或远端端部(这些术语具有相同的意思)收缩的缝隙的优点在于在沿着缝隙的长度从近端至远端流动的清洗流体中出现的压降能够被保持为低水平,如与在缝隙的整个长度上的具有最小宽度的相同的长度的非收缩的缝隙中的压降相比较。以这种方式,提供例如1至1.5bar的压力的清洗流体泵也可以被使用,即使具有非常小的最小缝隙宽度。
更具体地,缝隙可以朝向缝隙的前端或叶轮侧端部收缩,使得缝隙的最小宽度位于在缝隙的最靠近缝隙的叶轮侧端部的长度的30%内的某处。更优选地,所述最小宽度至少存在于缝隙的叶轮侧端部。
在最小缝隙宽度实际上被限于缝隙的叶轮侧端部,即限于缝隙长度为无限短的节段的情况下,这可能导致在缝隙的相应节段中增加的磨损。因此,根据优选的实施方式,缝隙的具有最小缝隙宽度的节段可以延伸经过缝隙的长度的50%或更小,优选地30%或更小,但是优选地不小于缝隙的长度的20%,以将磨损保持为低水平。这样的节段的长度可以在0.1和0.7mm之间的范围内,更优选地在0.2和0.4mm之间。
缝隙的收缩可以通过一个或两个形成缝隙的表面的锥形实现,即由经过壳体壁的开口的内表面形成缝隙的锥形的外表面,由轴的表面形成缝隙的锥形的内表面。缝隙的外表面的锥形意指朝向缝隙的叶轮侧端部的壁开口的直径的减小,缝隙的内表面的锥形意指朝向缝隙的叶轮侧端部的轴的直径的增加。优选的是在轴的表面中设置锥形,而构成缝隙的外边界的开口可以是圆柱形的,因为容易制造。
缝隙的优选的长度在从1至2mm的范围内,优选地1.3至1.7mm,而最小缝隙宽度可以是5μm或更小,优选地4μm或更小,更优选地3μm或更小,并且最优选地2μm或更小。最大缝隙宽度典型地位于缝隙的与缝隙的叶轮侧端部相反的端部并且达到15μm或更小,优选地10μm或更小,更优选地8μm或更小,并且最优选地6μm或更小。最优选的是具有约6μm的最大缝隙宽度和2μm或更小的最小缝隙宽度的收缩的缝隙。
此外,缝隙可以连续地,特别是线性地,收缩经过其的长度的至少一部分,直到缝隙具有其最小宽度之处。
附图说明
在下文,将参考附图以实施例的方式解释本发明。附图不意图是按比例绘制的。在附图中,每个在各个附图中图示的相同的或近似地相同的部件被相似的数字表示。为了清楚性的目的,不是每一个部件可以在每一个图中被标记。在附图中:
图1是被插入左心室之前的血管内血泵的示意图,其吸入插管被定位在左心室中,
图2是示例性的现有技术血泵的示意性的纵向截面,
图3是图2的血泵的一部分的放大图,然而,具有根据本发明的一个优选的实施方式的结构,并且
图4A至图4I是泵的远端径向轴承的放大部分视图,示出了收缩的周向缝隙的变化形式。
图1表示在本特定实施例中使用血泵用于支持左心室。血泵包括导管14和附接至导管14的泵送装置10。泵送装置10具有马达节段11和泵节段12,其被同轴地一个布置在另一个后方并且导致棒形状的构造形式。泵节段12具有以柔性的吸入软管13的形式的延伸部,吸入软管13往往被称为“插管”。叶轮设置在泵节段12中以引起从血液流动入口至血液流动出口的血液流动,并且叶轮的旋转由布置在马达节段11中的电动马达引起。血泵被放置为使得其主要地位于升主动脉15b中。主动脉瓣18在关闭状态中成为抵靠泵节段12或它的吸入软管13的外侧。具有在前方的吸入软管13的血泵通过前探导管14前探入被表示的位置中,可选择地采用导丝。这样的话,吸入软管13逆行经过主动脉瓣18,所以血液被经过吸入软管13吸入并且被泵送入主动脉16中。
血泵的用途不限于在图1中表示的应用,在图1中表示的应用仅涉及应用的典型的例子。因此,泵也可以被插入穿过其他的周围血管,例如锁骨下动脉。可选择地,对于右心室的反向应用可以被设想。
图2示出了根据现有技术US 2015/0051436 A1的血泵的一个示例性的实施方式,其同样地适合于在本发明的上下文中使用,除了根据本发明改进使用“I”标记的、被环绕的前端部,这样的改进的一个优选的实施方式在图3中示出。据此,马达节段11具有长形的壳体20,电动马达21可以被容纳在长形的壳体20中。通常方式下,电动马达21的定子24可以具有许多的周向分布的绕组,以及在纵向方向的磁返回路径28。磁返回路径28可以形成长形的壳体20的外圆柱形套筒。定子24可以围绕连接至马达轴25的转子26,并且由在活动方向被磁化的永磁体组成。马达轴25可以延伸经过马达壳体20的整个长度,并且在远端穿过开口35从后者突出出来。在那里,它承载叶轮34,使泵叶片36从其突出,叶轮34可以在管状的泵壳体32内旋转,管状的泵壳体32可以牢固地连接至马达壳体20。
马达壳体20的近端端部具有密封地附接至其的柔性导管14。用于向电动马达21供应电力和控制电动马达21的电缆23可以延伸经过导管14。另外地,清洗流体管线29可以延伸经过导管14,并且穿透马达壳体20的近端端壁22。清洗流体可以经过清洗流体管线29被供入马达壳体20的内部中,并且经过在马达壳体20的远端端部的端壁30离开。清洗压力被选择为使得其高于存在的血液压力,以由此防止血液渗透入马达壳体中,取决于应用的情况在300和1400mmHg之间。
如上文提到的,相同的清洗密封部可以与被柔性驱动轴和远程马达驱动的泵相结合。
在叶轮34的旋转时,血液被经过泵壳体32的远端开口37吸入,并且在泵壳体32内在轴向方向向后地输送。经过泵壳体32中的径向出口开口38,血液从泵节段12流动出来,并且进一步地沿着马达壳体20流动。这确保在马达中产生的热量被带走。也有可能的是,使用逆向输送方向操作泵节段,使血液被沿着马达壳体20吸入并且从泵壳体32的远端开口37离开。
在一个方面,马达轴25在马达壳体20的近端端部安装在径向轴承27中,在另一个方面,在马达壳体20的远端端部安装在径向轴承31中。径向轴承,特别是在马达壳体的远端端部在开口35中的径向轴承31,被构造作为滑动轴承。此外,马达轴25也轴向地安装在马达壳体20中,轴向轴承40同样地被构造作为滑动轴承。轴向滑动轴承40被用作当叶轮34将血液从远端输送至近端时,承受马达轴25的在远端方向作用的轴向力。如果血泵用于也或仅在逆向方向输送血液,那么相应的轴向滑动轴承40可以(也或仅)以相应的方式设置在马达壳体20的近端端部。
图3更详细地示出了在图2中使用“I”标记的部分,但已根据本发明的一个优选的实施方式在结构上被改进。特别是可以看到径向滑动轴承31和轴向滑动轴承40。径向滑动轴承31的轴承缝隙,在一个方面由马达轴25的周向表面25A形成,在另一个方面由马达壳体20的端壁30的衬套或套筒33中的通孔的表面33A形成,马达壳体20的端壁30界定约1mm的外缝隙直径,但是外缝隙直径也可以大于此。在本实施方式中,径向滑动轴承31的轴承缝隙具有2μm或更小的缝隙宽度,不但在缝隙的前端或叶轮侧端部,而且在径向滑动轴承的整个长度上。优选地,缝隙宽度在1μm和2μm之间。缝隙的长度可以在从1mm至2mm的范围内,优选地从1.3mm至1.7mm,例如1.5mm,相应于径向滑动轴承31的长度。形成径向滑动轴承31的缝隙的表面具有0.1μm或更小的表面粗糙度。
轴25优选地由陶瓷材料制造,最优选地由氧化铝增韧氧化锆(ATZ)制造,以避免轴断裂。由于铝具有在30和39W/mK之间的热导率,ATZ具有相对高的热导率。在轴25的远端端部上承载的叶轮34优选地由具有甚至更高的热导率的材料制造。以这种方式,在径向滑动轴承31的非常窄的缝隙中产生的热量,能够经过轴25和叶轮34消散入沿着叶轮34的外表面流动的血液中。
然而,在叶轮由具有低的热导率的材料例如PEEK制造的一个实施方式中,或甚至在叶轮由具有高的热导率的材料制造的实施方式中,如上文提出的,在任何情况下,有利的是使用具有高的热导率的材料制造在壳体20的端壁30中的套筒33,优选地至少100W/mK的热导率,更优选地至少130W/mK,甚至更优选地至少150W/mK,并且最优选地至少200W/mK。特别地,套筒33可以是陶瓷套筒,更具体地由烧结陶瓷材料制造。作为一个特别地优选的陶瓷材料,套筒33可以包含或整个地由SiC组成,因为其的高的热导率。
虽然整个端壁30可以作为由高度热传导材料制造的一体件被形成,但是可以优选的是由套筒33和一个或更多个本身热传导的径向外部元件33B组装端壁30。这在套筒33由脆性材料例如SiC制造的情况下可能是特别重要的。据此,径向外部热传导元件33B热传导地连接至套筒33,并且本身具有优选地高于套筒33的热导率的热导率,并且在任何情况下是至少100W/mK,从而确保来自套筒33的热量能够通过热传导和扩散经过热传导元件33B消散入流动的血液中。
如能够从图3进一步地看到的,与在图2中示出的现有技术结构相比,壳体20的端壁30的轴向长度是相对长的。更具体地,用于血液沿着壳体20的端壁30的外表面流动的路径在轴向方向比在径向方向长。这提供用于热量从壳体20的端壁30传递入血流中的大的表面积。例如,血流可以被沿着壳体20的端壁30向外地引导经过在0.5和1mm之间、优选地约0.75mm的径向距离,同时在轴向方向流动1.5mm至4mm、优选地约3mm。
关于轴向滑动轴承40的轴承缝隙,其由端壁30的轴向内部表面41和与其相对的表面42形成。该相对的表面42可以是陶瓷圆盘44的一部分,陶瓷圆盘可以在远端固定在转子26的马达轴25上,并且随着转子26旋转。通道43可以设置在端壁30的轴承缝隙表面41中,以确保清洗流体经过轴向滑动轴承40的轴承缝隙表面41和42之间朝向径向滑动轴承31流动。除这之外,轴向滑动轴承40的表面41和42可以是平坦的。轴向滑动轴承40的轴承缝隙是非常小的,是几微米。
当轴向滑动轴承40的轴承缝隙表面41由套筒33形成,如在图3中示出的,并且套筒33由SiC制造时,形成轴向滑动轴承40的相对的表面42的陶瓷圆盘44优选地由氧化铝增韧氧化锆(ATZ)制造。可选择地,相对的轴承缝隙表面42可以是DLC包覆的或可以同样地由SiC制造。
清洗流体的压力被调节使得沿着径向滑动轴承31的压降优选地是约500mmHg或更多,以在窄的1至2μm缝隙内保持高的轴向清洗流动速度(≥0.6m/s)。血泵10可以使用没有肝素的清洗流体来操作。如果清洗失败的话,血泵可以甚至在没有任何清洗流体的情况下持续运行至少几小时。
图4A至图4C示出了界定在血泵壳体20的远端端部的径向滑动轴承31的周向缝隙(在此具体地被附图标记39指定)的变化形式。更具体地,周向缝隙39在这些变化形式中从近端至远端收缩。箭头指示使用于清洗径向滑动轴承31的清洗流体的流动方向。
收缩的缝隙39的第一实施方式在图4A中示出。在此,缝隙从近端至远端连续地收缩,更具体地线性地收缩,使最小缝隙宽度精确地位于缝隙39的叶轮侧端部39A。
在图4B中示出的实施方式中的缝隙39,同样地朝向缝隙39的叶轮侧端部39A从近端至远端连续地并且线性地收缩,但是最小缝隙宽度延伸经过缝隙39的部分长度,从而形成其圆柱形的端部节段。如在图4B中示出的缝隙39的圆柱形的端部节段,比如在图4A的实施方式中示出的尖的端部节段较不易于磨损。在两个实施方式中,缝隙都可以可选择地非线性地收缩,特别是凸形地或,换句话说,从近端至远端递减地收缩。
在图4A和图4B中示出的实施方式中,缝隙39的收缩是由于具有与近端相比更窄直径的远端的开口35的锥形,而同时图4C和图4D涉及缝隙39的收缩由轴25的锥形来实现的实施方式。更具体地,在两个情况中,轴25的外径都朝向缝隙39的叶轮侧端部39A延伸。在图4C中,轴25的外径从在缝隙39的近端侧的恒定直径轴节段扩大至在缝隙39内的最大外径,该恒定直径轴节段延伸经过缝隙39的、与缝隙39的叶轮侧端部39A相反的端部。在图4D中示出的实施方式中,轴的外径具有周向凹槽,凹槽同样地延伸经过缝隙39的、与缝隙39的叶轮侧端部39A相反的端部。在示出的实施方式中,凹槽的直径从近端至远端线性地增加,使得最小缝隙在缝隙39的叶轮侧端部39A之前很快被达到。然而,代替线性地收缩的缝隙39,轴25的直径可以增加,例如渐进地朝向缝隙39的叶轮侧端部39A增加。
在图4A至图4D中示出的关于实施方式所描述的变化形式可以被以任何合适的方式组合,即,收缩的缝隙39既可以通过轴25延伸穿过其中的开口的成锥形的直径形成,也可以通过成锥形的轴25形成。
图4E至图4I涉及关于收缩的缝隙39的为易于制造而优化的泵的远端径向轴承31的实施方式。在图4E中轴承31被分割为两个轴承套圈31A和31B,与血液接触的远端轴承套圈31A具有比近端轴承套圈31B的开口小的直径的开口。在图4F中收缩的缝隙由在轴25的表面25A中的周向凹槽25B实现,凹槽25B具有简单曲线的截面。在图4G中收缩的缝隙同样地由在轴25的表面25A中的周向凹槽25B实现,但是此处凹槽25B使得轴25在缝隙39的区域中具有圆锥形的轴向截面。在图4H中轴承31通过阶梯孔形成,阶梯孔在与血液接触的远端端部具有与缝隙39的近端端部相比较小的直径,与图4E的实施方式相似。在图4I中,再次地,轴承31被分割为两个轴承套圈31A和31B,使与血液接触的远端轴承套圈31A具有比近端轴承套圈31B小的直径。然而,在本实施方式中,近端轴承套圈31B具有圆柱形的内表面,而远端套圈31A具有朝向缝隙的叶轮侧端部39A收缩的圆锥形内径。
Claims (26)
1.一种血管内血泵,包括承载叶轮(34)的可旋转的轴(25)和具有开口(35)的壳体(20),其中所述轴(25)延伸穿过所述开口(35),所述叶轮(34)被定位在所述壳体外,所述轴和所述壳体具有形成在所述开口(35)内的周向缝隙的表面(25A、33A),其中所述缝隙具有长度并且具有在所述长度的至少一部分上的2μm或更小的宽度,并且其中形成所述缝隙的所述表面(25A、33A)中的至少一个(33A)由具有至少100W/mK的热导率的材料制造。
2.根据权利要求1所述的血管内血泵,其中所述热导率是至少130W/mK。
3.根据权利要求1所述的血管内血泵,其中所述热导率是至少150W/mK。
4.根据权利要求1所述的血管内血泵,其中所述热导率是至少200W/mK。
5.根据权利要求1至4中任一项所述的血管内血泵,其中形成所述缝隙的所述表面构成用于所述轴的径向滑动轴承。
6.根据权利要求1至4中任一项所述的血管内血泵,其中形成所述缝隙的所述表面(25A、33A)中的所述至少一个(33A)构成结构元件(33)的一部分,所述结构元件(33)整个地由所述材料制造并且当所述血管内血泵在患者的血管中使用时与流动的血液直接接触。
7.根据权利要求1至4中任一项所述的血管内血泵,其中形成所述缝隙的所述表面(25A、33A)中的所述至少一个(33A)构成结构元件(33)的一部分,所述结构元件(33)整个地由所述材料制造并且具有至少一个热传导地连接至热传导元件(33B)的另外的表面,所述热传导元件(33B)当所述血管内血泵在患者的血管中在操作中时与流动的血液直接接触或经过一个或更多个另外的热传导元件与流动的血液间接热传导接触,使得来自形成所述缝隙的所述表面(25A、33A)中的所述至少一个(33A)的热量能够通过热传导消散入所述流动的血液中,其中所述一个(33B)或更多个热传导元件的所述热导率是至少100W/mK。
8.根据权利要求1至4中任一项所述的血管内血泵,其中形成所述缝隙的所述表面(25A、33A)中的每个具有0.1μm或更小的表面粗糙度。
9.根据权利要求1至4中任一项所述的血管内血泵,其中所述至少一个表面(33A)由陶瓷材料制造。
10.根据权利要求1至4中任一项所述的血管内血泵,其中所述至少一个表面(33A)构成所述轴(25)能够在其中滑动的陶瓷套筒(33)的一部分。
11.根据权利要求1至4中任一项所述的血管内血泵,其中包括所述轴的形成所述缝隙的所述表面(25A)的所述轴(25)由陶瓷材料制造。
12.根据权利要求11所述的血管内血泵,其中所述轴的形成所述缝隙的所述表面(25A)由氧化铝增韧氧化锆(ATZ)制造。
13.根据权利要求1至4中任一项所述的血管内血泵,其中所述至少一个表面(33A)包含碳化硅(SiC)。
14.根据权利要求13所述的血管内血泵,其中所述至少一个表面(25A、33A)中的一个(33A)包含碳化硅(SiC),并且所述至少一个表面(25A、33A)中的另一个(25A)包含氧化铝增韧氧化锆(ATZ)。
15.根据权利要求1至4中任一项所述的血管内血泵,还包括清洗流体供应管线(29),所述清洗流体管线连接至所述壳体并且设置为将清洗流体引导入所述壳体中从而经过所述开口(35)离开所述壳体。
16.根据权利要求1至4中任一项所述的血管内血泵,其中所述缝隙(39)朝向所述缝隙(39)的叶轮侧端部(39A)收缩,并且2μm或更小的所述宽度位于所述缝隙(39)的所述长度的最靠近所述缝隙(39)的所述叶轮侧端部(39A)的50%内的某处。
17.根据权利要求16所述的血管内血泵,其中2μm或更小的所述宽度存在于所述缝隙(39)的所述叶轮侧端部(39A)。
18.根据权利要求16所述的血管内血泵,其中2μm或更小的所述宽度延伸经过所述缝隙(39)的所述长度的30%或更小。
19.根据权利要求16所述的血管内血泵,其中所述开口(35)的直径朝向所述缝隙(39)的所述叶轮侧端部(39A)收缩。
20.根据权利要求16所述的血管内血泵,其中所述轴(25)的外径朝向所述缝隙(39)的所述叶轮侧端部(39A)扩大。
21.根据权利要求20所述的血管内血泵,其中所述轴(25)的所述外径具有延伸经过所述缝隙(39)的与所述缝隙(39)的所述叶轮侧端部(39A)相反的端部的周向凹槽。
22.根据权利要求20所述的血管内血泵,其中所述轴(25)的所述外径从延伸经过所述缝隙(39)的与所述缝隙(39)的所述叶轮侧端部(39A)相反的端部的恒定直径轴节段扩大至在所述缝隙(39)内的最大外径。
23.根据权利要求16所述的血管内血泵,其中所述缝隙(39)的最大宽度是15μm或更小。
24.根据权利要求23所述的血管内血泵,其中所述缝隙(39)的最大宽度是6μm或更小。
25.根据权利要求1至4中任一项所述的血管内血泵,其中所述缝隙(39)的所述长度在从1至2mm的范围内。
26.根据权利要求25所述的血管内血泵,其中所述缝隙(39)的所述长度在从1.3至1.7mm的范围内。
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