CN113226439A - 开放式电动泵 - Google Patents
开放式电动泵 Download PDFInfo
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Abstract
一种可植入式泵被配置来与来自心脏的血流串联植入。所述泵包括:框架,所述框架被配置来植入在所述心脏的天然血流诸如所述心脏的心室流出道、出口瓣膜内;以及中心轴,所述中心轴被配置来平行于所述血流附连在所述框架内。所述泵还包括:转子,所述转子附接到所述中心轴并且被配置来旋转以便泵送血液;以及至少两个电磁线圈,所述至少两个电磁线圈被配置来被通电以便致使所述转子旋转。
Description
相关申请的交叉引用
本申请要求临时申请号62/711,856的提交日期的优先权权益,所述申请的整个内容以引用的方式并入本文。
背景技术
技术领域
本公开涉及用于泵送流体的开放式电动泵。具体地,本公开描述可被植入衰竭心脏中以辅助血液的泵送的开放式电动泵。
相关技术描述
心脏衰竭患者具有无法通过患者的循环***充分地泵送血液的衰竭心脏。因此,已经开发了循环辅助装置以便帮助衰竭心脏泵送血液。此类装置可包括旋转式轴流泵或离心泵,这些泵具有通过自旋来泵送血液的转子。这些常规泵还包括围绕转子的外壳,并且在转子与外壳壁之间具有非常小的公差。这种“封闭式”设计在常规泵的电机停止泵送的情形下导致对血液流动产生严重阻力,这可在相关联电池组变得耗尽的情形下或在常规泵本身失灵的情形下发生。
为了在泵停止泵送的情形下维持循环,必须平行于心脏的天然血流,通常从左心室的顶点到升主动脉或降主动脉使用常规泵。从主泵送腔或前腔到主动脉或肺动脉的其他平行泵配置也用于左心脏支撑或右心脏支撑。即使泵暂时地停止,此平行配置也允许天然心脏射血并且支持循环。将常规泵与来自心脏的血流串联植入,诸如植入在左心室流出道中或主泵送腔的出口瓣膜内在常规泵停止泵送(诸如在电池交换期间、与电池意外断开连接或泵失灵)的情形下可导致灾难性循环虚脱。这是因为常规泵的封闭式设计在泵停止时允许非常少的血液穿过它们。
常规泵还包括生成热量的线圈,所述热量通过外壳传递到周围组织和血液。这可致使血液和周围组织变暖到引起血液蛋白和其他细胞血液成分受损的程度,从而可能导致凝血和血栓栓塞。
因此,存在对新泵设计的需要,所述新泵设计能够与心脏的血流串联植入而不会在泵停止的情形下对血液流动引起显著阻力,并且使对血液和周围组织的创伤最小化并且使到周围组织的热传递最小化。
发明内容
本公开涉及具有“开放式”设计以允许将泵与来自心脏的血流串联放置的泵。所述泵的开放式设计还允许更大、更有效的转子,其以更低转子速度有效地泵送血液,从而导致对血液及其细胞成分产生更少剪切力并且因此产生更少创伤。所述泵的开放式设计在泵停止的情况下大大地降低对血液流动的阻力,从而使循环虚脱的风险最小化。因此,本文所述的本发明泵可被放置在例如左心室或右心室流出道中或右心室或左心室的出口瓣膜的位置内,而不会对常规泵具有任何负面影响。
与常规泵相比,由于暴露于血液的表面积更大,开放式设计进一步提供更好的热交换和可能更少的血液创伤。与常规泵相比,在所述泵中电磁线圈的表面的更大部分与血流接触。这允许血液成分具有更好的散热功能并且较不易变暖,并且降低血栓栓塞并发症的可能性。本发明的开放式泵也可被配置成使得从血流内进行血管内/微创放置是可能的。
具体地,在本公开的一个方面,可植入式泵被配置来与来自心脏的血流串联植入。所述泵包括:框架,所述框架被配置来植入所述心脏的心室流出道中;以及中心轴,所述中心轴被配置来平行于所述血流附连在所述框架内。所述泵还包括:转子,所述转子附接到所述中心轴并且被配置来旋转以便泵送血液;以及至少两个电磁线圈,所述至少两个电磁线圈被配置来被通电以便致使所述转子旋转。
推进所述泵转子的电脉冲的定时是基于霍尔传感器或来自经过线圈的旋转磁体的反电磁脉冲感测(反EMP感测)。所述泵由机电或电子外部控制单元(图片中未示出)控制,所述机电或电子外部控制单元具有通过手动控制来调整泵旋转速度的能力并且还可具有可自动地调整的可变泵速度特征件,所述可变泵速度特征件利用用于患者心脏的电活动(诸如在心电图中)的传感器或利用检测患者的物理活动程度或检测患者的呼吸率和身***置的运动传感器基于患者传感器输入(诸如患者的心率)来调整所述旋转速度。
所述泵转子和框架由生物相容性材料(诸如不锈钢、金属合金(诸如钛合金,如镍钛诺)或其他金属合金)制成,轴承由诸如陶瓷、蓝宝石或红宝石或金属或金属合金的材料制成。所述转子可由磁性金属或金属合金制成。所述泵的所述电线圈由诸如金属线(如铜线或金线)或者任何合适的金属或金属合金线的材料制成,并且被包封在由金属、金属合金或聚合物制成的防水外壳中。所述泵还使用聚合物来使线和线连接绝缘。
附图说明
在结合附图考虑时参考以下详细描述,可更好地理解本发明及其许多伴随优点,因此将容易获得对本发明及其许多伴随优点的更完全的了解,在附图中:
图1是根据本公开的示例性方面的开放式泵;
图2是根据本公开的示例性方面的开放式泵的另一个透视图;
图3是根据本公开的示例性方面的开放式泵的另一个侧视图;
图4是根据本公开的示例性方面的开放式泵的顶视图;
图5是根据本公开的示例性方面的开放式泵的透视图;
图6是根据本公开的示例性方面的开放式泵的侧视图;
图7是根据本公开的示例性方面的开放式泵的顶视图;并且
图8是根据本公开的示例性方面的开放式泵的透视图。
具体实施方式
现在参考图式,其中贯穿若干视图,相同附图标号指代相同或对应零件,图1是根据本公开的示例性方面的开放式泵。如图1所示,泵包括框架101,所述框架101保持转子102安装在其上的中心轴103。两个电磁线圈104和105也附接在中心轴103与框架之间,所述两个电磁线圈104和105在被通电时致使转子102转动。线圈104和105径向地或稍微“偏心”布置在血液通道内。为了对提供给电磁线圈104和105的信号正确地定时,使用霍尔传感器或使用反向电磁脉冲感测(EMP脉冲感测)。泵还包括用于***用于致使转子102旋转的一个或多个磁体的开口107,并且具有附接到线圈104、15以便向那些线圈提供电力的电力电缆108。开放式泵不包括外壳并且作为替代由框架101支撑,因此从而使对血液流动的阻力最小化。
图1还示出框架101将中心轴103保持在容纳轴套106的开口或类似保持装置中。轴套106可以是压配合的,并且可被加工成围绕其外圆周具有凹部以便配合在框架101中的开口内。轴套还可包括轴承、轴承组件或铅笔尖形轴承以便允许中心轴103以最小阻力自由地自旋。当然,在不脱离本公开的范围的情况下,其他轴套和轴承设计也是可能的。
尽管图1示出中心轴103通过轴套106保持在框架101的任一侧处,但可省略轴套106并且中心轴103可直接由框架101保持而无需任何其他结构。为了防止中心轴103脱离框架101而独自工作,可使用开尾销或类似结构。框架101中的保持中心轴103的孔也可以是并不沿框架材料的整个厚度延伸以便使中心轴103保持在适当位置的“盲”孔。普通技术人员将认识到,在不脱离本公开的情况下,将中心轴103可旋转地附连到框架101的其他方式是可能的。
图2是根据本公开的示例性方面的开放式泵的透视图。为了清楚起见,在图2中省略转子。图2的框架201包括线圈205放置在其中的凹部。如可见,两组相对的电磁线圈205径向地位于框架201中。它们还可具有稍微“偏心”配置以允许泵仅在一个方向上旋转。轴套106保持转子可安装在其上的中心轴3(未示出)。使用一对电磁线圈允许利用反电磁脉冲感测对到达线圈的电脉冲进行定时,从而消除对霍尔传感器的需要。而且,此配置允许使用更高功率的电机,所述更高功率的电机由于泵的微创放置所需的大小约束而可能是可用的。具有4个或更多个磁体的这种设置有利于使用EMP反感测来对泵进行定时,因为泵可由一对磁体推进,而另一对磁体被设置在感测模式下较短时间段。
图3是图2的开放式泵的侧视图。为清楚起见,在图3中省略转子、中心轴103以及保持中心轴103的轴套106。如可见,图1d中的框架201的结构包括两个构件202、203,所述两个构件202、203各自保持两个电磁线圈以及分别附接到两个构件202、203的端部的两个端板204和206。然而,在不脱离本公开的范围的情况下,框架201也可被制成为单一件。
图4是图2和图3的开放式泵的顶视图。在图4中,示出轴套106、端板204、206以及构件中的一个构件203。如从此图可见,线圈205由构件203保持在凹部中的适当位置,所述凹部由构件203的侧壁产生以用于线圈205。因为构件203的侧壁围绕线圈205弯曲,所以无需另外的保持器来将线圈205保持在适当位置。然而,作为构件203的弯曲侧壁的补充或替代,还可使用另外的保持器(诸如夹具、螺钉等)以便将线圈250保持在适当位置。如本领域的普通技术人员将认识到,也可使用树脂或粘合剂来将线圈205保持在适当位置。尽管未示出,但构件202具有与构件203基本上相同的结构。
图5是根据本公开的示例性方面的开放式泵的透视图。泵包括框架301,所述框架301包括汽缸302,所述汽缸302保持围绕其内圆周布置的多个电磁线圈305。汽缸302包括两个支撑件304,所述两个支撑件304支撑用于保持转子306的中心轴的轴套308放置在其中的梁303。类似梁也附连到汽缸302的相反侧。汽缸302可由用于微创植入的柔性材料(诸如保持刚性支撑梁303和304的血管内支架)制成。转子306包括磁体307,所述磁体307与电磁线圈305组合致使转子306自旋。转子可具有不同于此示意图中(诸如图1中)的形状以最佳地推进血液。转子本身也可由磁性材料制成,这从而避免了对单独磁体的需要。如可见,电磁线圈305垂直于或略微倾斜于转子306并且平行于血液的流布置。尽管图5示出6个线圈305,但如本领域的普通技术人员将认识到,取决于应用,可使用更多或更少线圈305。
图6是图5的开放式泵的侧视图。如从此视图可见,转子306悬挂在汽缸302和电磁线圈305上方,使得泵的整体结构保持开放并且对血液流动呈现低阻力。线圈305可经由压配合在围绕汽缸302的圆周形成的单个汽缸中保持在适当位置,或者可利用粘合剂或树脂粘合在适当位置。线圈305也可利用保持器或紧固件(诸如夹具)而被机械地保持。在不脱离本公开的范围的情况下,用于将线圈305保持在适当位置的其他方法和结构也是可能的。
图7是图5和6的泵的顶视图。此图示出泵的开放式设计,所述开放式设计允许血液流动,即使在泵停止时也是如此。所述图还示出保持转子306的轴309的轴套308。如可了解,可省略轴套308,并且可直接通过框架301和位于轴309的每个端部处的开尾销将轴309保持在适当位置。
图5至图7所示的泵可缩放以配合在人类心脏中,并且可将垂直于转子在血流的方向上定向的电磁线圈安装在血管支架或支架移植物(未示出)上。也可利用由金属、金属合金(诸如镍钛诺)或聚合物制成的柔性圆形或对角地定向的金属支柱将电磁线圈保持在适当位置。
图8是根据本公开的示例性方面的开放式泵的透视图。图8中的泵包括框架402安装在其中的汽缸401。框架402保持转子403的中心轴。沿着汽缸401的内圆周的是相对于血流以预定角度布置的多个电磁线圈404。如本领域的普通技术人员将认识到,此预定角度可以是介于0度至180度之间的任何角度。如可了解,汽缸401可用将泵保持在心脏中的适当位置的支架或支架移植物替换。框架402也可与汽缸401形成为一个件。401示出具有“双叶片转子”的另一个示例性转子配置。在不脱离本公开的范围的情况下其他变化形式是可能的。
尽管为了清楚起见单独地描述了上述泵,但本领域的普通技术人员将认识到,针对一个泵描述的不同特征可与其他泵的特征组合而不受限制。
此外,就本文的图和描述标识具体数量的电磁线圈而言,此类数量仅是示例性的,因为对于每个泵,可使用更多更弱线圈,或可使用更少更强线圈。泵还可由与活组织中的植入兼容的任何材料制成,并且部分或整个泵可涂覆有保形涂层以便保护泵部件。
为了清楚起见,在本文已参考将本发明泵植入衰竭心脏中进行了描述。然而,本发明泵可在要求在停止时对流动呈现很小阻力的泵的其他应用中使用。因此,本文的描述仅是示例性的并且不限制本公开的范围。显然地,鉴于以上教导内容,本公开的众多修改和变化是可能的。因此,应理解,在所附权利要求的范围内,本发明可以不同于如本文具体描述的方式来实践。
Claims (10)
1.一种可植入式泵,其被配置来与来自心脏的血流串联植入,所述泵包括:
框架,所述框架被配置来植入在所述心脏中的血液的天然血液路径中,包括植入在所述心脏的心室流出道中或所述心脏的出口瓣膜的适当位置中;
中心轴,所述中心轴被配置来平行于所述血流附连在所述框架内;
转子,所述转子附接到所述中心轴并且被配置来旋转以便泵送血液;以及
至少两个电磁线圈,所述至少两个电磁线圈被配置来被通电以便致使所述转子旋转。
2.根据权利要求1所述的可植入式泵,其中所述框架在所述血流的方向上具有至少一个开口,以在所述转子不旋转时允许所述血液流动而不受阻碍。
3.根据权利要求1所述的可植入式泵,其中所述至少两个电磁线圈定位成相对于所述血流的方向是径向的。
4.根据权利要求1所述的可植入式泵,其中所述至少两个电磁线圈定位成垂直于所述转子。
5.根据权利要求1所述的可植入式泵,其中所述至少两个电磁线圈两者在所述框架中位于所述转子的同一侧上。
6.根据权利要求1所述的可植入式泵,其中所述至少两个电磁线圈中的第一个电磁线圈位于所述转子的第一侧上,并且所述至少两个电磁线圈中的第二个电磁线圈位于所述转子的与所述第一侧相反的第二侧上。
7.根据权利要求1所述的可植入式泵,其中所述至少两个电磁线圈布置成与所述血流成预定角度。
8.根据权利要求1所述的可植入式泵,其中所述框架包括圆柱形构件,所述圆柱形构件的开口定位成与所述血流一致。
9.根据权利要求8所述的可植入式泵,其中所述至少两个电磁线圈沿着所述圆柱形构件的内圆周定位。
10.根据权利要求8所述的可植入式泵,其中所述圆柱形构件是支架或支架移植物。
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JP2021532958A (ja) | 2021-12-02 |
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AU2019315428A1 (en) | 2021-03-04 |
US11793993B2 (en) | 2023-10-24 |
KR20210060444A (ko) | 2021-05-26 |
CA3108320A1 (en) | 2020-02-06 |
EP3829674A4 (en) | 2022-07-13 |
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AU2019315428B2 (en) | 2024-06-20 |
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