CN101951973A - 铂-钴-硼血泵元件 - Google Patents
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Abstract
本发明公开了一种血泵的磁性叶轮,其中血泵例如是用于抽吸患者血液的磁性驱动的旋转式心室辅助装置,所述叶轮包含含有铂、钴和硼的磁性合金。
Description
技术领域
本发明涉及一种用在血泵例如旋转式心室辅助装置(VAD)中的包含含有有效量的铂、钴和硼的合金的叶轮。
背景技术
在心血管医学中,心室辅助装置(VAD)作为心脏移植的桥梁或作为晚期治疗形式来支持晚期心脏病患者的临床应用已成为可接受的临床实践。据估计,超过35,000个患有晚期心脏衰竭的患者是心脏支持疗法的候选者。
VAD可以使用血泵为患者的血液提供动量,从而将血液推向更高压力。尤其是,旋转式VAD是一种包括电磁耦合叶轮的血泵,通过叶轮旋转以有助于患者的循环系统。
于2008年2月26日提交的美国专利申请No.12/072,471(将其公开内容并入本申请作为参考)提供了一种血管内旋转式VAD的例子,它可以植入患者体内,为患有充血性心脏衰竭等症状的心脏的血液抽吸提供协助。这种血管内旋转式VAD是一种微型VAD,由于其尺寸小,所以具有很多应用。这种微型化使得侵入性植入更少的新技术成为可能,预期这会缩短患者的术后恢复时间。
美国专利申请公开No.US2007/0078293A1(将其公开内容并入本申请作为参考)提供了一种包含铂-钴合金的血泵叶轮,其可被高度磁化并可以作为单件制造。
美国专利No.4,983,230(将其公开内容并入本申请作为参考)记载了一种用于各种应用的具有高矫顽力的磁性铂-钴-硼合金。
本发明提供了一种用在例如旋转式VAD中的改进血泵叶轮。已经发现,包含含有预定量的铂、钴和硼的合金的叶轮效率更高并具有优越的磁性、机械性能和生物相容性。这些优越的性能使VAD泵的进一步微型化和流线型化成为可能,这对于VAD行业以前是不可能的。
发明内容
本发明的一方面提供了一种血泵例如旋转式VAD的磁性叶轮。根据本发明的这个方面,优选地,所述血泵的磁性叶轮包含含有铂、钴和硼的磁性合金。更优选地,所述磁性叶轮包含主要由约12-14at%的硼以及铂与钴的原子百分比比率为0.90-1.2的铂和钴构成的合金。最优选地,所述磁性叶轮包含主要由约13at%的硼、42at%的铂和45at%的钴构成的磁性合金。
本发明的另一方面提供了一种用于抽吸患者血液的磁性驱动的可植入的旋转式心室辅助装置。根据本发明的这个方面,所述心室辅助装置包括叶轮,所述叶轮包含含有铂、钴和硼的磁性合金。优选地,所述心室辅助装置的叶轮包括单一体,并具有生物相容的血液接触面,所述血液接触面包含主要由铂、钴和硼构成的磁性合金。更优选地,所述叶轮包含主要由约12-14at%的硼以及铂与钴的原子百分比比率为0.90-1.2的铂和钴构成的合金。最优选地,所述磁性叶轮包含主要由约13at%的硼、42at%的铂和45at%的钴构成的磁性合金。
主要由约13at%的硼、42at%的铂和45at%的钴构成的叶轮或者主要由铂和钴构成的叶轮其磁性增强,使得转子和定子之间的效率更大。这种效率导致了具有医疗优势的进一步微型化。
附图说明
为进一步理解本发明,可以参照附图,从中将易于理解本发明的本质优点和附加优点,在附图中:
图1示出了根据本发明一个实施例的可植入的密封旋转式血泵的放大纵剖面图;
图2是图1所示的泵的旋转式叶轮的放大立体图;
图3和图4是图2所示的叶轮处于不同位置的其他侧视图;
图5为沿图2的线5-5的剖视图。
具体实施方式
在描述附图中所示的本发明实施例时,为清楚起见使用具体术语。然而,本发明的公开内容并不意图局限于所选择的具体术语,应该理解的是,每个具体元件包括以相似方式操作的所有技术等同物。
现在参照图1~5,示出了根据本发明各实施例的叶轮或转子14。“叶轮”被定义为泵的可移动的流体驱动部。从图1中可以看出,叶轮14可定位在轴流旋转式VAD泵10中。
在一个实施例中,叶轮14包含含有铂、钴和硼的合金。更优选地,合金含有12-14at%(原子百分比)的硼以及铂与钴的原子百分比比率为0.90-1.2的铂和钴。在优选实施例中,铂的含量略小于钴的含量。最优选地,合金主要由铂、钴和硼构成。例如,合金可以含有约42at%的铂、45at%的钴和13at%的硼。
如美国专利No.4,983,230中所公开的,铂、钴和硼合金可以通过铂、钴和硼的均匀熔体的快速固化来形成。该美国专利还公开了,铂、钴和硼的均匀熔体的快速固化和固化合金的热处理,对于含有12-14at%的硼以及铂与钴的原子比率为0.90-1.1的合金而言,可以产生12-14KOe的固有矫顽力。另外,此处公开的合金具有生物相容性并且具有高耐腐蚀性,这使其适于接触血液。此外,由于上述合金具有磁各向同性,因此合金可被高度磁化,多个磁极在任意几何方向取向。再者,合金通常洛氏硬度为31Rc级,这避免了对硬质外涂层的需要。由于上述优点,可以实现高效、紧凑的VAD设计,这避免了对构造常规磁铁组件和支撑构造的需要,从而降低了制造成本。此外,通过避免对常规组件和支撑构造的需要,进一步增加了微型化的可能性。
整个叶轮14可以通过加工合金的固化单件来形成,然后以需要的磁极分布对其进行磁化。优选地,叶轮14形成为包含上述合金的一体件,使用常规金属加工方法可将其制成复杂的形状,这不同于用在常规旋转式VAD中的其他“高强度”永磁体。单件叶轮的使用避免了装配过程以及与传统方法中将磁性材料置于叶轮壳内并将封闭帽激光焊接在壳上有关的气密封问题。单件叶轮可以完全由主要含有铂、钴和硼的生物相容性合金构成,这确保了整个叶轮(包括叶轮的外表面和内部)的生物相容性,使其适于接触血液。
叶轮14可被磁化成使得北磁极(N)和南磁极(S)位于叶片状突起20上(如图4所示)。
图1~5中所示的叶轮14可在VAD 10(图1)中运行,如下面所描述的。
叶轮或转子14可以定位在泵壳体12的管腔内,并且随着叶轮14顺时针旋转,具有液力面(具体而言,一系列液力面16,倾向于沿箭头18所示的轴向方向推动血液)。血泵10可与患者的血管系统连接,以作为旋转式VAD起作用。
如图1所示,叶轮14可以包括向外径向延伸并具有壁16的叶片状突起20,壁16限定突起20之间的通常纵向延伸的空间22。构成液力面的突起20和其侧壁16可以成形为在纵向延伸空间22中形成曲线形,随着叶轮14旋转(在图1所示的实施例中,顺时针方向旋转),这种形状趋于将血液沿轴向方向18驱动。
从图5中可以看出,各纵向延伸空间22一起的总圆周宽度可以基本上小于各突起20一起的总圆周宽度。如图5所示,各纵向延伸空间22具有圆周或外围宽度26。四个纵向延伸空间22的四个外围宽度26一起构成所有纵向延伸空间22的总外围宽度。相似地,弧28的距离代表叶片状突起20的圆周或外围宽度。纵向延伸空间22一起的总外围宽度基本上小于各叶片状突起20一起的总外围宽度。
优选地,纵向延伸空间22的横截面具有通常平行的侧壁16,但是从图1和其他附图中可以看出,纵向延伸空间22的总宽度可沿其长度改变,如图1所示,在上游区域30较窄,在下游区域32较宽。转子14的顺时针旋转会导致血液在壳体12的管腔中自左向右沿方向18流动。
血泵10还可以包括电机定子36(如图1所示),电机定子36包括位于包围壳体12和叶轮或转子14的机罩40内的导电线圈38。电机定子36用于通过将电力常规施加到线圈38上,然后转化为使叶轮14根据电力的极性顺时针旋转或逆时针旋转的磁场,从而转动叶轮14。用于实现此功能的具体技术与现有技术中公知的相似。
图1~4示出了叶片状突起20的径向外面42,还示出了在图1~5所示实施例中可被限定在突起20上的一对液力轴承44、46,当叶轮14旋转时它们利用流体压力使叶轮14在管状壳体12的管腔内居中,而不需要利用摩擦固体表面的物理轴承。
因此,叶轮14可由位于各叶片状突起20上的液力轴承44、46支持远离壳体12的内壁而旋转。在叶轮14的后方,壳体12的内环形环52(如图1所示)可从壳体12的内圆柱壁向内突出,以限制转子14的向左运动。环52可以包括一系列环形间隔突起,或者其可以包括实体环,使得液力轴承44用于防止随着转子14顺时针旋转而操作泵时转子14与环52之间的接触。出于相似目的,可在壳体12的另一端附近限定相似的环形环53。
各推力轴承44、46可限定凹陷的弯曲外表面,其相对于各突起20的外面42形成凹陷端部,从转子14的(顺时针)旋转角度观察,外面42位于各轴承44、46的向前端,使得凹陷端形成旋转的前边缘。该凹陷表面可以逐渐弯曲的方式向外朝各推力轴承44、46的后端渐缩,在后端处,轴承表面以相似于美国专利No.6,234,772中所描述的方式不凹陷或仅是极轻微凹陷。
因此,随着叶轮14的旋转,各叶片状突起20上的各个推力轴承44、46将血液推向各轴承的从端到端降低的截面凹陷区域,其作用是对血液增压,从而随着叶轮14的旋转使各突起20抵抗壳体12的内壁。由于叶轮14与壳体12的壁相间隔,所以经增压的血液流经端部而从各轴承放出,并从凹陷的侧面流出。在各旋转的突起20的旋转尾端设置有减压区。
在一个实施例中,定子36可以包括单独的密封线圈电机,它在管状壳体12的适当位置上滑动,并紧固在定子36上。可选择地,定子36和线圈38可一体连接到壳体12上。
在一个实施例中,定子可以减小到所需宽度的一半。这种直径上的减小增多了VAD植入人体的方法。先前,早期申请中的血管内VAD具有3/8英寸的直径。使用本发明的叶轮,VAD的外径比早期申请中的装置小25%。本发明外径的减小将产生侵入性更少的外科植入技术,从而缩短患者的恢复时间。
图1~5中所示的VAD 10与2004年12月3日提交的美国专利申请No.11/003,810中公开的相似,但本发明做出了改进,本文将该专利申请的公开内容并入作为参考。
在上述实施例中,叶轮14整个形成为单一体,其包含生物相容性的铂、钴和硼合金。然而,这并不是必须的。例如,叶轮14可以包含由本文公开的生物相容性的铂、钴和硼合金及其他材料的组合所形成的非单一体。例如,铁磁性材料如铁或铁镍合金(具有所需的铁磁性,但却不与血液相容)可被包含在叶轮的内部。这种叶轮的包含生物相容性和生物不相容性主体部的一部分或优选所有的外部血液接触面可由上述含有铂、钴和硼的生物相容性的合金来限定,从而确保叶轮的血液接触面是生物相容的。如果合金没有形成所有的外表面,那么外表面的剩余部分可由另一种生物相容性材料形成。叶轮可被磁化,多个磁极在任意几何方向取向。
可以预期的是,包含本文所述的合金的叶轮可被设计成沿逆时针方向旋转,从而利用上述原理和优点。
还可以预期的是,包含本文所述的铂、钴和硼合金的叶轮可被设计成用在混流式和离心流式心室辅助装置中,从而利用上述原理和优点。
虽然已经结合特定实施例对本发明进行了描述,但是应该理解的是,这些实施例仅用于说明本发明的原理和应用。因此,应该理解的是,在由所附权利要求书限定的本发明精神和范围内,可以对说明性实施例做出各种修改,并可以设计出其他配置。
Claims (15)
1.一种血泵的磁性叶轮,所述叶轮包含含有铂、钴和硼的磁性合金。
2.根据权利要求1所述的磁性叶轮,其中所述叶轮具有包含所述合金的血液接触面。
3.根据权利要求2所述的磁性叶轮,其中整个所述血液接触面均由所述合金构成。
4.根据权利要求1所述的磁性叶轮,其完全由所述合金形成。
5.根据权利要求1所述的磁性叶轮,其完全由所述合金的单件形成。
6.根据权利要求1所述的磁性叶轮,其中所述合金主要由铂、钴和硼构成。
7.根据权利要求1所述的磁性叶轮,其中所述合金含有约12-14at%的硼。
8.根据权利要求1所述的磁性叶轮,其中所述合金含有铂与钴的原子百分比比率为0.90-1.2的铂和钴。
9.根据权利要求1所述的磁性叶轮,其中所述合金含有约12-14at%的硼,并含有铂与钴的原子百分比比率为0.90-1.2的铂和钴。
10.根据权利要求6所述的磁性叶轮,其中所述合金含有约13at%的硼、42at%的铂和45at%的钴。
11.根据权利要求7所述的磁性叶轮,其中所述磁性合金具有12-14KOe的矫顽力。
12.一种用于抽吸患者血液的磁性驱动的可植入的旋转式心室辅助装置,其包括如权利要求1-11中任一项所述的叶轮。
13.根据权利要求12所述的心室辅助装置,其中所述装置还包括电机定子,其被构造和配置成提供用于使所述叶轮绕轴旋转的磁场。
14.根据权利要求12所述的心室辅助装置,其中所述装置提供轴向血流。
15.根据权利要求9所述的心室辅助装置,其中所述装置提供离心的血流。
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CN102755672A (zh) * | 2012-06-21 | 2012-10-31 | 北京工业大学 | 采用高磁导率材料叶轮的血泵 |
CN104740704A (zh) * | 2015-04-21 | 2015-07-01 | 傅风荣 | 一种治疗心血管疾病的医疗器械微动力泵 |
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CN110621357A (zh) * | 2017-05-19 | 2019-12-27 | 心脏器械股份有限公司 | 中心杆磁体 |
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Cited By (2)
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CN102755672A (zh) * | 2012-06-21 | 2012-10-31 | 北京工业大学 | 采用高磁导率材料叶轮的血泵 |
CN104740704A (zh) * | 2015-04-21 | 2015-07-01 | 傅风荣 | 一种治疗心血管疾病的医疗器械微动力泵 |
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WO2009099653A1 (en) | 2009-08-13 |
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US20090204205A1 (en) | 2009-08-13 |
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