CN106061523B - 便携式血液透析机和一次性药筒 - Google Patents
便携式血液透析机和一次性药筒 Download PDFInfo
- Publication number
- CN106061523B CN106061523B CN201580010630.XA CN201580010630A CN106061523B CN 106061523 B CN106061523 B CN 106061523B CN 201580010630 A CN201580010630 A CN 201580010630A CN 106061523 B CN106061523 B CN 106061523B
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- Prior art keywords
- blood
- sensor
- dialyzate
- dialyzer
- cartridge case
- 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.)
- Expired - Fee Related
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Abstract
提供了一种便携式的血液透析系统,其包括一次性药筒和重复使用的透析机。所述一次性药筒包括透析器,和透析液流动路径和沿相反方向流过透析器的血液流动路径。所述一次性药筒包括用于从透析液除去废物的过滤器和用于测量透析液流动路径和血液流动路径中的压力和流体流速的压力和流体流量传感器。另外,所述一次性药筒拥有泵致动器(而不是泵用马达)以用于泵送透析液和血液通过其相应流动路径。所述重复使用的透析机拥有用于透析液的储罐、液位传感器、血液渗漏传感器、氨气传感器、静脉血管线压力传感器、静脉血管线气泡检测器、泵用马达和连接至电动机与传感器以用于控制和监控血液透析治疗的处理器。
Description
相关申请
本申请是2014年2月27日提交的待审美国临时专利申请序号61/945,698的继续。上述申请的内容通过引用被结合到本文中。
背景技术
本发明涉及一种供提供透析之用的人造肾脏系统。更特别地,本发明是针对一种血液透析系统,其显著地改善了血液透析治疗以便为更广泛基础的病人提供血液透析并且降低血液透析的总成本。
因此,申请人在本文中通过参引结合本申请中所引用或参考的任何和所有专利和公开专利申请。
血液透析是一种医疗过程,其被用于实现从病人的血液中体外移除包括肌酸、尿素和自由水分的废物,涉及溶解物横跨半渗透膜的扩散。无法恰当地除去所述废物可能引起肾衰竭。
在血液透析期间,病人的血液通过动脉管线移除、通过透析机处理并且通过静脉管线被返回身体中。透析机包括透析器,透析器包含形成半渗透膜的大量中空纤维,血液通过半渗透膜运送。另外,透析机使用包含适当量的电解液及其他主要成分(诸如,葡萄糖)的透析液,其也被泵送通过透析器。
一般地,通过将水与适当比例的酸浓缩物和碳酸氢盐浓缩物混合来制备透析液。优选是,酸和碳酸氢盐浓缩物被分开直到在透析器中使用之前最后混合好,因为酸浓缩物中的钙和镁当与碳酸氢盐浓缩物中的高碳酸氢盐水平接触时将沉淀析出。透析液可以还还包括适当水平的钠、钾、氯化物和葡萄糖。
通过扩散和对流的组合来实现横跨薄膜的透析过程。扩散必然伴有分子通过不规则运动从高浓度的部位迁移到低浓度的部位。同时,对流必然伴有溶解物一般响应于静压差的运动。形成半渗透膜的纤维将血浆与透析液分开并且为扩散的发生提供了较大的表面面积,其允许包括尿素、钾和磷酸盐的废物渗透到透析液中而同时防止诸如血细胞、多肽和某些蛋白质的较大分子转移到透析液中。
一般地,透析液在体外回路中沿与血液流动相反方向流动。所述逆向流动保持了横跨半渗透膜的浓度梯度以便增大透析的效率。在有些情况下,血液透析可以考虑到除去流体,也被称为超过滤。超过滤通常通过降低透析器的透析液隔室的流体静压来实现,因此允许包含包括电解液及其他可渗透物质的含水溶解物从血浆横穿薄膜移动至透析液。在较稀薄的情况中,透析器的透析液流动路径部分中的流体比血液流动部分的高,促使流体从透析流动路径移动至血液流动路径。这通常被称为反向超过滤。因为超过滤和反向超过滤可能增大对病人的风险,所以超过滤和反向超过滤一般仅当由训练有素的医务人员指导时实施。
遗憾的是,血液透析遭受了许多缺点。动静脉瘘是最普通公认的进入点。为了产生瘘管,医生将动脉和静脉联接到一起。因为这绕过了病人的毛细管,血液快速地流动。对于每个透析期间,必须以大针刺穿瘘管以将血液传送到透析器中并使血液从透析器返回。一般地,该过程一周做三次并且每次治疗3-4小时。对于稍低程度,病人在家实施血液透析。在家透析一般做两个小时,一周做六天。在家血液透析被认为更少紧张并且因为一般以导管实施而被认为更简单。然而,在家血液透析需要更频繁的治疗。
在家血液透析还遭受了另外的不利。当前的家用透析系统是较大的、复杂的、吓人的并且难以操作的。所述设备需要显著的训练。家用的血液透析系统目前是太大以致不是便携的,从而妨碍血液透析病人的旅行。家用的血液透析系统是昂贵的并且需要很高的初始金钱投资,特别是与其中病人不需要负担机械装置的费用的在血液中心的血液透析相比。现有的家用血液透析系统未充分地考虑到供给品的重复使用,使得家用的血液透析对于医疗供应商来说经济上更不可行。因为上述不利,很少促使病人接受在家血液透析的苦差事。
因此,显著需要一种便携式的、轻重量的、易于使用的、对病人友好的并且因此能在家使用的血液透析系统。
此外,希望提供一种在泵、马达、管或者电子设备中没有将危及病人的单个故障点的家用血液透析系统。
本发明的方面满足这些需求并且进一步提供了如以下发明内容中所描述的相关优点。
发明内容
根据本发明的第一方面,提供了一种血液透析系统,其包括连接至病人动脉用以从病人收集血液的动脉血管线、连接至病人静脉用以使血液返回到病人的静脉血管线、可再用的透析机和一次性药筒。在本发明的第二方面,本发明考虑到一种供血液透析机之用的药筒。
动脉血管线和静脉血管线可以是为本领域技术人员所知的典型构造。例如,动脉血管线可以是连接至用于从病人的动脉收集血液的针的传统的柔性中空管子。类似地,静脉血管线可以是用于使血液返回到病人静脉的传统的挠性管和针。各种构造和外科手术过程可被应用以便获得至病人血液通路,包括静脉内导管、动静脉瘘或者合成的移植物。
一次性药筒预定用于单个病人治疗且不可重复使用。一次性药筒包括为本领域中的技术人员所公知的构造和设计的透析器。合适的透析器可从Fresenius Medical Care、Baxter International,Inc和Nipro Medical Corporation处获得。优选地,透析器包括形成半渗透膜的大量中空纤维。
一次性药筒包括血液流动路径和透析液流动路径。血液流动路径通过连接用于将血液从病人输送给透析器的动脉血管线和使血液返回到病人的静脉血管线来按闭环系统输送血液。同时,透析液流动路径按照从储罐到透析器并且返回到储罐的闭环系统中输送透析液。血液流动路径和透析液流动路径两者都穿过透析器,但是被透析器的半渗透膜分隔开。
优选地,所述药筒包括三个泵致动器。对于本文的目的,术语“泵”是指涉及利用吸力或者压力使流体运动的致动器和用于机械地使致动器运动的马达两者。合适的泵致动器可以包括叶轮、活塞、振动膜、凸轮泵的凸轮、螺旋泵的螺旋、蠕动泵的滚子或者线性运动指状件或者如本领域普通技术人员可以确定的用于使流体运动的任何其他机械构造。同时,马达是用于使致动器运动的机电装置。马达可以通过轴或类似物被连接至泵致动器。在优选实施例中,一次性药筒的泵致动器是包括可滑动地安装到转子上的叶片的滑动叶片式旋转泵构造,该转子在外壳的中央空腔内部转动。转子是圆形的并且在更大的基本上圆形的空腔内转动。转子的中心相对于空腔的中心偏移以引起偏心。叶片被允许滑入和滑出转子以便与空腔的内部侧壁密封以形成泵送流体的叶片腔室。如以下更详细地阐述的,优选地,所述一次性药筒不包括泵用马达。
第一和第二泵致动器被连接至透析液流动路径以用于通过透析液流动路径将透析液从储罐泵送至透析器并且返回到储罐。优选地,第一泵致动器被从透析器的“上游”(意味着在流动路径之前)连接至透析液流动路径,而第二泵致动器被从透析器的“下游”(意味着流动路径之后)连接至透析液流动路径。同时,一次性药筒的第三泵致动器被连接至血液流动路径。第三泵致动器将血液从病人泵送通过动脉血管线、通过透析器并且通过静脉血管线以用于返回到病人。优选是,第三泵致动器被从透析器的上游连接至血液流通路径。一次性药筒可以容纳多于或者少于三个泵致动器。例如,透析液可以仅利用单个泵致动器被经由透析器泵出。然而,优选是,一次性药筒容纳两个泵致动器,包括透析器上游的第一泵致动器和透析器下游的第二泵致动器。
所述一次性药筒还包含连接至透析液流动路径的过滤器以用于除去已经通过半渗透膜从血浆渗透到透析液中的毒素。优选地,过滤器被从透析器的下游连接至透析液的流动路径,以便在透析液被输送到储罐中之前将由透析器传送到透析液中的毒素移除。供所述药筒使用的过滤器材料对本领域的技术人员来说是公知的。例如,合适的材料包括包含锆基树脂的树脂层。优选地,过滤器具有包含氧化锆层、磷酸锆层和碳层的外壳。在美国专利No.8,647,506和美国专利申请公开文件No.2014/0001112中描述了可接受的材料。其他可接受的过滤器材料可以在不过度实验的情况下由本领域普通技术人员研发和利用。优选地,过滤器外壳包括能释放包括氨气的气体的蒸气薄膜,但是液体且特别是透析液体不能流过过滤器。
优选地,所述一次性药筒包含用于监控血液透析的传感器。为此,优选地,所述药筒具有连接至透析液流动路径以用于检测透析液流动路径内部的流体流(体积和/或速度)的流量传感器。另外,优选是,所述一次性药筒包含用于检测透析液流动路径内的压力的一个或多个压力传感器。优选地,所述一次性药筒还具有用于测量血液流动路径内的压力和/或流体流的一个或多个传感器。在优选实施例中,所述药盒具有四个压力传感器,包括测量透析器上游的透析液流的压力的第一压力传感器、测量透析器下游的透析液流的压力的第二压力传感器、测量透析器上游的血液流的压力的第三压力传感器和测量透析器下游的血液流的压力的第四压力传感器。此外,优选的盒具有四个流量传感器,包括测量透析器上游的透析液流的流量的第一流量传感器、测量透析器下游的透析液流的流量的第二流量传感器、测量透析器上游的血液流的流量的第三流量传感器和测量透析器下游的血液流的流量的第四流量传感器。所述压力和流量传感器可以是独立的部件,或者压力和流量测量可以由单个传感器进行。例如,在优选实施例中,透析液流动路径具有用于仅测量压力的两个压力传感器和用于仅测量流量的两个传感器,结果形成了监控透析液流动路径中的透析液的压力或者流量的四个传感器。然而,所述优选的一次性药筒仅包括连接到血液流动路径的两个传感器,其中每个传感器能够测量压力和流量两者。为了传送由流量传感器和压力传感器所产生的测量结果,优选地,一次性药筒具有在外部安装的电端子,其被电连接至流量传感器和压力传感器。
优选是,所述一次性药筒是由诸如高等级的聚碳酸酯或者丙烯酸的耐用而高强度的塑料制成的。聚碳酸酯和/或丙烯酸因为对于其极高电阻的其高反射指数性能及很好的介电常数而被认为是有利的。优选地,所述药筒的血液流动路径和透析液流动路径是形成于药筒的塑料外壳内部的管道。此外,优选是,一次性药筒是无管的,意味着除了动脉血管线和静脉血管线之外在整个血液透析系统内部没有可接近病人或者临床医师的挠性管。具体地说,所述一次性药筒外壳和泵致动器优选是由坚硬的塑料制成的并且不采用任何挠性管,诸如应用于蠕动泵。
除了一次性药筒之外,血液透析系统包括可再用的“透析机”,其配合所述一次性药筒以用于连接至并控制该一次性药筒的泵致动器并且用于监控该一次性药筒的传感器。为此,优选的透析机包括用于接合并操作所述药筒的三个泵致动器的三个泵用马达。更具体地说,所述透析机包括用于接合并操作连接至透析液流动路径的第一和第二泵致动器的第一和第二泵用马达。透析机的第三泵用马达接合并操作被连接至血液流动路径的所述药筒的第三泵致动器,以用于控制泵送血液通过药筒的血液流动路径。有利地,优选是,泵用马达和泵致动器可在不使用工具的情况下通过仅仅手动地使泵致动器压靠泵用马达或者引起透析机或一次性药筒的损坏而轻易地相互结合和分离。泵用马达和泵致动器可以利用本领域技术人员已知的各种构造被机械地连接。例如,泵用马达或者泵致动器可以包括定位成伸入并接合相应泵致动器或者泵用马达内部的带键接受器的带键的轴。然而,在优选实施例中,泵用马达和泵致动器通过多个磁铁相连,其中泵用马达具有定位成结合泵致动器内部的相反极性的磁铁的多个磁铁。
优选地,透析机包含用于储存透析溶液的储罐。当透析机已经与一次性药筒配对时,储罐连接至药筒的透析液流动路径以形成用于将透析液从储罐输送至药筒的透析器并返回储罐的闭环系统。储罐可以是临床医师执行适当的血液透析治疗所需的任何尺寸的。然而,优选是,储罐足够小以使得所述透析机是易于携带的。
透析机优选具有用热的方法连接至储罐的用于加热储存在储罐内部的流体的加热器。所述加热器优选通过电力起动并且包括随着电流的经过产生热量的电阻器。
为了监控血液透析系统的正确操作,所述透析机具有各种传感器。所述透析机包括用于测量储罐内的流体的温度的温度传感器。另外,所述透析机具有用于检测储罐中的流体的液位的液位传感器。此外,优选是,所述透析机包括血液渗漏检测器,其监控透析液通过透析液流动路径的流动并且检测血液是否已经通过透析器的半渗透膜不适当地扩散到透析液流动路径中。
透析机优选包括:包含邻近一次性药筒的蒸气薄膜定位的氨气传感器的附加传感器,以便检测在药筒的过滤器内是否形成有氨气;用于检测静脉血管线中的压力的静脉血管线压力传感器;和连接至静脉血线的用于检测是否已经在静脉血管线中形成气泡的气泡传感器。所述透析机可以还包含连接至静脉血管线的用于有选择地允许或者隔断血液通过静脉血管线流动的夹管阀。所述夹管阀被设置成以便夹住静脉血管线并且从而在任一传感器已经检测到不安全状况的情况中防止血液流回至病人。
所述透析机具有包含用于控制血液透析系统的专用电子设备的处理器。处理器包含连接至泵用马达、透析机传感器和夹管阀的电力管理电路,以用于控制血液透析系统的正确操作。另外,所述透析机具有定位成接合并电力地连接至一次性药筒的电端子,以便使所述药筒的流量传感器和压力传感器连接于处理器,以使得所述处理器还可以监控所述一次性药筒的传感器。所述处理器监控多个传感器中的每一个以确保血液透析治疗按照由医务人员输入到用户界面中的预编程的程序而进行。
所述透析机和一次性药筒提供了一种便携的、重量轻的、易于使用的、对病人友好的且能在家使用的血液透析系统。
有利地,所述一次性药筒和血液管线在提交给病人之前被杀菌并且在血液透析治疗之后被处理掉。因为所述血液管线被直接连接至一次性药筒而不是被连接之重复使用的机器,所以对污染敏感的所有部件在每次治疗之后被丢弃并且在下次治疗之前被替换。
此外,有利地,所述血液透析系统除了动脉血管线和静脉血管线之外未应用任何挠性管以便减小对病人潜在危险的区域。
另外,所述血液透析系统提供了血液透析系统先前未提供的非常大量的控制和监控以便提供增进的病人安全。
本领域的普通技术人员在读取紧跟着参考附图的详细说明时将意识到本发明的其他特征和优点。
附图说明
图1是根据至少一个实施例的图解成用于治疗病人的血液透析系统的透视图;
图2是图解根据至少一个实施例的血液透析系统的分解透视图;
图3是根据至少一个实施例的血液透析系统的另一分解透视图;
图4是根据至少一个实施例的血液透析系统的透视图;
图5是根据至少一个实施例的透析机的托盘上方的血液透析系统的一次性药筒的分解透视图;
图6是图解根据至少一个实施例的供血液透析系统使用的包括泵致动器和泵用马达的优选泵的分解透视图;
图7是图解根据至少一个实施例的供血液透析系统使用的储罐和过滤器的分解透视图;
图8是图解根据至少一个实施例的当过滤器连接至血液透析系统的储罐时包括过滤器的血液透析系统的一次性药筒的透视图;
图9是根据至少一个实施例的血液透析系统的一次性药筒的俯视图;
图10是根据至少一个实施例的血液透析系统的一次性药筒的仰视图;
图11是图解根据至少一个实施例的用于接收一次性药筒的透析机的托盘的俯视图;
图12是图解根据至少一个实施例的包括压力传感器、气泡传感器和夹管阀的血液透析系统的安全设备的流程图;
图13是图解根据至少一个实施例的血液和透析液通过血液透析系统流动的流程图;
图14是图解根据至少一个实施例的血液透析系统的各种电子设备和机电部件的图表;
图15是图解根据至少一个实施例的血液和透析液通过血液透析系统流动的更详细的流程图;
图16是根据至少一个实施例的氨气传感器的示例性加热器的电路图;和
图17是图解根据至少一个实施例的由示例性液位传感器所提供的电极的排列的图表。
具体实施方式
虽然本发明可以有呈如附图中所示的多种形式的实施例,但是在下文中将描述本发明的当前优选实施例,能理解的是,本公开被认为是本发明的范例并且其不意图将本发明限制于所图解的具体实施例。
参见图1-15,本发明的血液透析系统1包括可再用的透析机201、一次性药筒11、包括用于连接患者的动脉的针7的动脉血管线3、和包括用于连接患者的静脉的针7的静脉血管线5。特别是参见图1-5和15,所述一次性药筒11包括具有提供血液流动路径15的管道17和提供透析液流动路径19的管道21的外壳13。优选地,所述药筒的血液流动路径和透析液流动路径是具有大约0.156英寸(3-5毫米)内径的管道。一次性药筒11可以是单件式构造。然而,优选地且如本文所述,所述一次性药筒可以被拆卸成多个零件以允许透析器25和过滤器79分离,但是所述多个零件可以被组装到一起以形成一次性药筒11。优选地,所述药筒的外壳是由联邦药品管理局许用的材料制成的。用于所述药筒的外壳的目前优选的材料是聚碳酸酯塑料。
所述一次性药筒的血液流动路径15在一端处连接至动脉血管线3且在另一端处连接至静脉血管线5。血液流动路径15和透析液流动路径19两者都穿过透析器25以将其相应的流体输送通过闭环系统,在该闭环路径中透析液流动路径通过半渗透膜(未显示)被从血液流动路径隔离开。优选地,透析液在透析器25内部沿与血流相反方向地流动,所述透析器具有用于接收透析液的进口31、用于排出透析液的出口33、用于从病人接收血液的进口27和用于将血液返回给病人的出口29。
更特别地并且如图1、3和9中所示,一次性药筒的外壳13包括用于将透析器的进口27连接至动脉血管线3的联接器37和用于将透析器的血液出口29连接至静脉血管线5的联接器39。另外,一次性药筒的外壳13包括包含用于从储罐209来回输送透析液的管道21的盒部段23。为此,所述盒23通过联接器47和43连接至透析器的进口31和出口33。透析液通过盒的联接器47被接收到盒23中。此后,透析液穿过透析液流动路径19(管道21内部)行进直到在透析器的进口31处进入透析器25。透析液然后在透析器的出口33处排出透析器25并且通过管道21继续穿过透析液流动路径19直到在联接器43处排出盒23。
优选地,所述药筒的盒23具有两个泵致动器51和53。第一泵致动器51被定位在透析器25的上游以通过透析液流动路径19将透析液泵送至透析器25。第二泵致动器53几乎刚好被定位在透析器25的下游以用于从透析器25泵送透析液。通过相对于第二泵致动器53独立地控制第一泵致动器51的操作允许人们增大或者减小透析器25内部的透析液流体的压力。优选地,一次性药筒的外壳13包括第三泵致动器55,其被定位在连接至动脉血管线3的外壳联接器37内部。该第三泵致动器55泵送血液通过血液流动路径15并且优选被定位在透析器25的上游。
如图2、7和8中最佳地示出,一次性药筒11包括过滤器79。过滤器79包括用于包封过滤器材料的外壳81,所述过滤器材料用于从透析液体除去毒素。所述过滤器材料可以是已知的或者可以是所述领域的技术人员可以确定的用于从血液中除去主要为尿素和肌酸的各种废物的成分和构造。过滤器71包括进口83和出口85。过滤器的进口83连接至药筒的联接器43,并且过滤器的出口85连接至储罐的进口211,以下更详细地描述。在优选实施例中,过滤器的外壳81包括图7和8中所示的蒸气薄膜87。所述蒸气薄膜87是一种能释放包括氨气的气体的半渗透膜,但是液体且特别是透析液体不能流过过滤器79。
如以下详细论述的,所述一次性药筒11具有用于监控透析器25内部发生透析的各种传感器。如图5-10中所示,优选的一次性药筒11包括盒中的两个由流量传感器93和压力传感器95构成的对,以用于测量透析液流动路径19中的流体流速和透析液的压力。优选地,所述盒的流量传感器93分别被定位在透析器25的上游和下游。在优选实施例中,每个流量传感器93包括处于透析液流动路径中的圆形腔室91和所述腔室91内部的可转动的辐条轮(未显示),其被透析液的流所转动。优选地,所述轮的辐条包括两个相反极性的磁铁,其显示出所述轮的旋转位置和旋转速度,该旋转速度被用于确定流体流量。优选地,所述盒的用于测量透析液的压力的压力传感器95也被分别定位在透析器25的上游和下游,以用于测量透析液进入透析器25之前和透析液离开透析器25之后的透析液的压力。所述盒的压力和流量传感器可以是可由本领域技术人员选用的联邦药物管理局许用的传感器。
优选地,一次性药筒还具有刚好在从病人接收血液之后并且在使血液返回病人之前用于测量通过血液流动路径15的血液的压力和流体流速两者的附加传感器97。在优选实施例中,血液的压力和流体流速的测量两者都由单个传感器进行。如图5、9、10、13和15中最佳地示出的,优选的药筒11包括联接器37内部的第一压力/流量传感器97以用于在血液进入透析器25中之前当血液被动脉血管线3接收时测量血液的压力和流体的流速。另外,优选地,所述药筒具有联接器39内部的第二压力/流体传感器97以用于在血液通过静脉血管线5返回到病人之前测量血液的压力和流体的流速。为了传送由盒的流量传感器和压力传感器所产生的测量结果,一次性药筒11具有电端子101。
在图1-5中最佳地示出了血液透析系统的透析机201。优选地,透析机201具有箱体205和一次性的药筒11,所述箱体具有用于封装并保护透析机201的各种部件的空腔207。优选地,箱体205的尺寸适合于在商务班机的吊箱中平移。透析机201具有在血液透析过程期间用于储存透析液的储罐209。优选的储罐储存1加仑(3.785升)的透析液,所述透析液可以通过储罐的可移动盖215被导入储罐中。另外,储罐209包括进口211和出口213。如图7中最佳地示出的,储罐的进口211连接至一次性药筒的过滤器的出口85。同时,储罐的出口213连接至一次性药筒的连接器47。优选地,透析机具有加热器221(图15中示出),该加热器221热联接至储罐209以用于加热透析液并将其温度保持在期望的温度。
优选地,透析机201包括用于支承并匹配一次性药筒的外壳13、透析器25、动脉管线联接器37和静脉管线联接器39的托盘219。托盘219可以包括用于将一次性药筒11锁定成与透析机201接合的闩锁225。在优选实施例中,托盘219还包括用于联接至一次性药筒的三个泵致动器(51、53和55)的三个泵用马达(227、229和231)。参见图5、6和11,透析机包括用于与一次性药筒的第一泵致动器51联接的第一泵用马达227、用于与一次性药筒的第二泵致动器53联接的第二泵用马达221和用于与一次性药筒的第三泵致动器55联接的第三泵用马达231。优选地,所述泵用马达是如本领域技术人员可以选用的传统的市场上现货的电转马达。
如图6中所示,优选地,每个泵致动器(51、53和55)未采用提供泵送作用的可变形构件,诸如,应用于接合动脉管线或者静脉管线的普通的滚子泵。反而,优选的泵致动器具有滑动叶片式构造。为此,每个泵致动器包括用于将流体导入空腔63中的进口57和用于排出所述流体的出口59。此外,每个泵致动器包括具有用于接收径向运动的叶片69的槽缝67的圆形转子65。离心力、液压力和/或诸如弹簧或推杆的偏压器件将叶片推向空腔63的壁,以形成由转子、叶片和空腔侧壁所形成的腔室。在图6中所示的优选实施例中,由转子的转动所引起的离心力将叶片推向空腔的侧壁。优选地,空腔63和转子67是基本上圆形的并且转子被定位在更大的空腔内。然而,转子的中心和空腔的中心是相互轴向地偏移的(偏心的)。在操作中,转子65和叶片69形成叶轮。当转子转动时,流体通过进口57进入泵致动器中。转子和叶轮的转动将被推进的流体从泵致动器的出口59泵出。优选地,每个泵致动器是由包括联邦药物管理局认可的塑料的基本上不变形的材料制成的。如本文所使用的,术语“不变形的”不意味着指泵致动器部件在泵运转期间不会经历某些不重要的变形。然而,不变形的泵致动器的部件在某种意义上不变形以提供诸如由蠕动的滚子泵接合诸如血液管线的挠性管所提供的泵送作用,如当前血液透析治疗普通应用的。在优选实施例中,泵致动器的外壳和转子是由聚碳酸酯制成的,并且泵致动器的叶片是由聚醚酮醚(PEEK)制成的。
仍然参见图6,泵致动器的转子63可以通过本领域普通技术人员公知的各种构造被连接至电马达67。例如,转子可以包括轴,所述轴带有键以与形成于转子中的相应接受器形成压配合。然而,在图6中所示的优选实施例中,马达227和转子65用磁铁71联接。如图所示,优选的转子具有六个磁铁,其中的极性(北-南方向)对于每个相邻的磁铁71是交替的。类似地,马达227包含六个附加的磁铁71,其中每个磁铁的极性是交替的。当一次性药筒11被联接至透析机201时,马达的磁铁被定位并对准以与转子的磁铁紧密接触。磁力将泵用马达联接到泵致动器以使得泵用马达的受控致动使转子转动,并且从而操作泵致动器。
如以下详细地论述的,除了在一次性药筒11中发现的传感器之外,优选的透析机201还具有用于监控血液透析系统1的适当操作的各种传感器。例如,所述透析机优选包括用于测量储罐209内的透析液的温度的温度传感器223。另外,所述透析系统包括氨气传感器237(参见图15),该氨气传感器定位于过滤器的蒸气薄膜87附近以用于检测过滤器79内部的任何氨气。如图2、3和12中所示的,优选地,透析机201还包括一对传感器(239和241)和连接至静脉血管线5的阀245,以便为病人进一步提供附加的冗余安全措施。所述附加传感器包括用于测量静脉血管线5中的血液压力的压力传感器239和确定在静脉血管线5中是否存在任何不希望有的气泡的气泡传感器241。在血压不在预定范围内的情况中或者在检测到不希望有的气泡的情况中,夹管阀245被强制关闭。
参见图14,透析机201包括处理器249、用户接口25和用于向处理器249、用户接口251、泵用马达和传感器提供电力的电源253。处理器249通过传统的电路被连接至透析机的传感器(包括储罐液位传感器217、血液渗漏传感器235、氨气传感器237、静脉血管线压力传感器239和静脉血管线气泡传感器241)、三个泵用马达227、229与231和夹管阀245。另外,透析机具有用于连接至一次性药筒的电端子101的电端子247(参见图11)以便使处理器249与一次性药筒的传感器(包括流量和压力传感器)相连。处理器可以是包含如可以由本领域普通技术人员确定的硬件和软件的通用计算机或者微处理器以监控各种传感器并且提供加热器、泵和夹管阀的自动或者直接控制。处理器可以位于电路板的电子设备内部或者多个电路板的聚集配置内部。
在操作中,处理器249被电连接至第一、第二和第三泵用马达以用于控制泵用马达的起动和转动速度,该泵用马达进而控制泵致动器,该泵致动器进而控制血液通过血液流动路径和透析液通过透析液流动路径的压力和流体速度。通过独立地控制第一和第二泵致动器的操作,处理器可以保持、增大或减小透析器内部的透析液流动路径内的压力和/或流体流。此外,通过独立地控制所有三个泵致动器,处理器249可以控制透析器的半渗透膜两侧上的压力差以保持预定的压力差(零、正或者负)或者保持预定的压力范围。例如,大部分血液透析以半渗透膜两侧上的零或者接近零的压力差来执行,并且为此,处理器可以监控和控制泵以保持该期望的零或者接近零的压力差。备选地,处理器可以监控压力传感器并且控制泵用马达,并且进而控制泵致动器,以相对于透析器内部透析液流动路径的压力增大并保持透析器内部血液流动路径中的正压。有利地,该压力差可以受处理器的影响,以提供超过滤作用以及自由水分和溶解的溶解物从血液转移到透析液中。
此外,处理器监控所有的各种传感器以确保血液透析机高效且安全地运行,并且在检测到不安全或者未指定的状态的情况中,处理器修正缺陷或者停止进一步的血液透析治疗。例如,如果静脉血管线压力传感器239指示不安全的压力或者气泡传感器241检测到静脉血管线中气态的气泡,则处理器发出警报信号,停用泵,并且关闭夹管阀245以防止血液进一步流回至病人。类似地,如果血液渗漏传感器235检测到血液已经渗透过透析器的半渗透膜,则处理器249发出警报信号并且停止进一步的血液透析治疗。
透析机的用户接口251可以包括用于使病人或者医务人员能输入涉及治疗的指令或者使病人或者医务人员能监控血液透析系统的性能的键盘或者触摸屏。此外,处理器可以包括用于将信息或者控制传送至远程位置的Wi-Fi的联络性。
如上所述的,血液透析系统1结合有在之前从未并入到血液透析装置中的许多改进的传感器。改进的传感器包括氨气传感器237、液位传感器217和血液渗漏传感器235。这些传感器中的每一个在以下被更详细地描述。
氨气传感器系统
还如上所述,至少一个氨气传感器237被邻近于过滤器的蒸气薄膜87定位并且被构造成用于检测过滤器79内部的任何氨气。更详细地,在至少一个实施例中,每个氨气传感器237包含有具有以下参数的加热器(未显示):
在至少一个实施例中,由于氨气传感器237上的化学敏感膜的本性,重要的是,来自加热器的温度升高是可重复的并且在氨气传感器237的使用寿命上是一致的。为此,同样重要的是,控制施加给加热器的电力尽可能一致,特别是已知加热器的电阻在氨气传感器237的使用寿命上的变化。在至少一个实施例中,氨气传感器237使用与加热器串联的单个负载电阻。该配置对VCC以及RH方面的变化是极端敏感的。利用额定VCC=3.3V±3.0%和RL=36.5Ω±1.0%产生如以下表格中所表示的PH=0.0669W±10.3%(具有设计中心PH=0.0667W):
在至少一个实施例中,为了更紧密地控制加热器中的功率耗散,使用图16中所示的电路。LDO被用于强制通过RL的恒定电流,并且RP被用于平衡通过RH的电流。如以下表格中所表示的使用VFB=0.8V±1.25%,RL=13.0Ω±1%,RP=69.8Ω±1%,PH=0.0658W±1.65%(具有设计中心PH=0.0661W):
最大功率耗散为P(RL)=0.050W和P(RP)=0.076W,其在1/10W、0603电阻的正常工作参数内是良好的。LDO所需的最大VOUT是3.12V(V(RH)+VFB)。在62mA时的去励电压为~80mV。VCC(最小)=3.12+0.08=3.20V,其需要3.3V±3%的VCC电源。
在至少一个实施例中,氨气传感器237的敏感层具有化学抵抗特性。由于敏感层的制造,基准电阻R0(环境条件、合成空气)不能被紧密地控制。通过采用电流感测电阻RS并除以周围环境电阻将来执行气体感测,因为SnO2气体感测层在高温、偏压下减少了NH3(以及其他气体)并且导电率增大。RS/R0比值代表气体的浓度,并且被用作校准和阈值检测。下表中示出了敏感层的特性:
因为氨气传感器237的输出将横跨RL(差动器)读取,所以V(RL)必须保持低于转换器的差分全比例输入范围(0.5V)以用于适当的极限范围内的换算。由于R0的宽动态范围,显然必须切换多个电阻以便管理氨气传感器237的读出数据。以下图解了至少一个实施例的配置。对于涉及低电流,GPIO信号可以被假设为GND(或者重复地接近GND)。GPIO管脚保持在高-Z状态(浮动)状态,或者驱动0。
该构造用于确保实际横穿敏感层的最高电压以便确保在敏感层增益的边界处的正确减小。通过敏感层的最大电流和功率由以下公式限定:
还应当注意到,一旦预热后确定了基准线R0则转换器的内部增益可用于增大动态范围。
血液渗漏传感器
还如上所述,血液渗漏传感器235被定位和构造成用于检测血液是否已经渗透过透析器25的半渗透膜。更详细地,在至少一个实施例中,血液渗漏传感器235运用光学吸收原理来确定透析液中血液的存在。使用两个独立的波长发射器,血液渗漏传感器235补偿透析液透明度方面的变化。
液位传感器
也如上所述,至少一个液位传感器217被定位和构造成用于监控和测量透析液储罐209中的透析流体的液位(图13和15)。在至少一个实施例中,流体被容纳在储罐209内,并且液位传感器217被定位在储罐209外部并邻近储罐209。液位传感器217当其监控到透析液储罐209在液面方面升高和降低时提供安全判断功能。除了惨重的流体损耗(即,储罐209或者流动路径19破裂)以外,透析流体的增或减表示横跨透析器25的压力平衡是不正确的且必须调整。
更详细地,在至少一个实施例中,液位传感器217利用容量方面的变化来确定储罐209中的液面。一系列的电极260和零位面262邻近储罐209定位,并且给定电极260处的电容方面的变化反映存在或者没有适度地导电的透析流体。在至少一个实施例中,如图17中所示,电极260被按交错排列方式设置,以在电极260之间提供重叠。该重叠与不重叠的电极260相比还允许更好的液位分辨力(resolution)。电极260与零位面262(“GND”)之间的电容耦合依据透析流体的存在而变化。电容方面的该变化被测量并用于确定横跨所有电极260的液面。在电极260之间,液位传感器217包括湿的参考电极264和干的参考电极266,其被用作透析流体的电容耦合和周围的电容耦合的参考。在至少一个实施例中,湿的参考电极264被定位成始终在透析液液面的下方,并且干的参考电极266被定位成在正常运行期间始终处于透析液液面的上方。
继续参照图17,在至少一个实施例中,液位传感器217还提供了电容-数字转换器(未显示),其测量每一个电极260和零位面262之间的电容。液位传感器217还提供了AC屏蔽输出268,其与受驱动电极260同相并且被用于将电极260从偶遇的地面耦合隔离。AC屏蔽268被用在电极260后面的平面中以将电极260从偶遇的地面屏蔽出来并且处于电极位置以确保用于每个电极260的相等负荷。在至少一个实施例中,每个电极260是具有72mm2面积的带有12mm的总高度和12mm的总宽度的旋转九十度的对称的正方形(具有8.49mm边长的旋转正方形)。电极260在电极260的中心之间以7.5mm竖直地间隔开。由该空间所代表的透析流体的体积与流体液面处的横截面积成正比。在示例性实施例中,储罐209的横截面积为3.102mm2。利用下列公式来计算由液位方面的偏差表示的体积:
在所述示例性实施例中,液位传感器217具有±58ml的基本量程(±18.75mm),其代表5.8%的透析流体。
最后,关注如同所示和本文所描述的本发明的示例性实施例,应当意识到,公开了一种便携式血液透析机和一次性药筒。因为本发明的原理可以按超出所示和所描述的那些之外的许多构造来实施,所以应当理解,本发明无论如何不受示例性实施例的限制,而是通常指向一种便携式血液透析机和一次性药筒并且在不脱离本发明的精神和范围的情况下可以采取许多形式来这样做。本领域的普通技术人员应当意识到,本发明不限于所公开构造的特定几何结构和材料,而是在不脱离本发明的精神和范围的情况下反而可能必然伴有现在已知的或者稍后发展的其他功能上可比较的结构或者材料。此外,上述实施例中的每一个的各项特征可以被按任何逻辑方式地组合并且确定为包含在本发明的范围内。
本发明的备选实施例、元件或者步骤的组合将不被看作是限制。每个组构件可能被逐一地或者按与本文所公开的其他组构件的任何组合地提及和要求保护。可以预料到,组中的一个或多个构件可以包含在为了方便和/或专利性的理由的组中或者从其中删除。当任何所述包含或删除出现时,说明书被认定为包含如所修改后的组。
除非另有陈述,否则用于本说明书和权利要求中的表示特征、项目、数量、参数、性能、条件等的所有数字将被理解为在所有情况下由术语“大约”来修饰。如本文中所使用的,术语“大约”是指如此限制的所述特征、项目、数量、参数、性能或者条件包括超过和低于所述特征、项目、数量、参数、性能或者条件的值加或者减百分之十的范围。因此,除非相反地指出,否则说明书和所附权利要求中阐述的数字参数是可以改变的近似值。至少,不作为试图限制相当于权利要求范围的原理的应用,每个数字指示将至少被视为是根据所报告的有效数字的数量的并且适用普通的舍入技术。尽管阐述本发明的宽广范围的数值范围和值都是近似值,但是在具体实例中所阐述的所述数值范围和值被尽可能准确地转述。然而,任何数值范围或者值内在地包含必定由在其相应的试验测量中所发现的标准偏差所引起的某些误差。本文中的值的数值范围的详述仅预定用作逐个地涉及落入范围的每个单独数值的简写方法。除非本文中另有陈述,否则数值范围的每个独立的值被并入到本说明书中,好像其在本文中被逐一地叙述的一样。
用于描述本发明的上下文(特别是在以下的权利要求的上下文中)中的术语“一”、“一个”、“所述的”和类似的指示词将被视为涉及单数和复数两者,除非本文中另有陈述或者同上下文清楚地相抵触。本文所述的所有方法可以按任何合适的顺序执行除非本文中另有陈述或者同上下文清楚地相抵触。任何和所有实例的使用或本文所提供的示例性措词(例如,“诸如”)仅意图更好地说明本发明并且不对所要求的本发明范围产生限制。本说明书中没有措辞将被看作是指出任何未提出要求保护的元件对于实施本发明是必需的。
本文所公开的具体实施例可以使用“由...组成”或者“基本上由...组成”的措辞在权利要求中进一步限制。当被在权利要求中使用时,无论是提交的或者补充的每次修改,过渡术语“由...组成”排除了权利要求中未说明的任何元件、步骤或者成分。过渡术语“基本上由...组成”将权利要求的范围限制为指定的材料或者步骤并且其不会实质上影响基本的和新颖的特征。如所要求的本发明的实施例在本文中被固有地或者清楚地描述和赋能。
很清楚,逻辑代码、程序、模块、过程、方法和执行每种方法的相应元件的次序是纯粹示例性的。取决于实施,其可以被按任何次序地或者并行地执行,除非本公开内容中另外指出。此外,逻辑代码不是关联的,并且不限于任何特定的程序设计语言,并且可以包括在分配、未分配或者多处理环境中在一个或多个处理器上执行的一个或多个模块。
虽然已经图解和描述了本发明的几种特定形式,但是显然,在不脱离本发明的精神和范围的情况下可以进行各种修改。因此,本发明不意图受到除了以下权利要求之外的限制。
Claims (6)
1.一种血液透析系统,包括:
动脉血管线,所述动脉血管线用于连接至病人的动脉,以用于从病人收集血液;
静脉血管线,所述静脉血管线用于连接至病人的静脉,以用于将血液返回给病人;
可重复使用的透析机和一次性药筒,其中所述一次性药筒能连接至所述可重复使用的透析机并且能与所述可重复使用的透析机脱离连接;
所述一次性药筒包括:
透析器;
血液流动路径,所述血液流动路径连接至所述动脉血管线和所述静脉血管线,用于将血液从病人输送通过所述透析器并且返回至病人;
透析液流动路径,所述透析液流动路径与所述血液流动路径隔离开,用于将透析液从储罐输送至所述透析器并且输送回所述储罐;
第一泵致动器,所述第一泵致动器从所述透析器的上游连接至所述透析液流动路径,以用于泵送透析液通过所述透析液流动路径;
第二泵致动器,所述第二泵致动器从所述透析器的下游连接至所述透析液流动路径,以用于泵送透析液通过所述透析液流动路径;
第三泵致动器,所述第三泵致动器连接至所述血液流动路径,以用于泵送血液通过所述血液流动路径;
过滤器,所述过滤器从所述透析器的下游连接至所述透析液流动路径,以用于从所述透析液流动路径除去尿毒症性的毒素,所述过滤器定位在具有蒸气薄膜的外壳内,所述蒸气薄膜允许氨气穿过所述蒸气薄膜而不允许透析液体穿过所述蒸气薄膜;
第一流量传感器,所述第一流量传感器在所述透析器上游连接至所述透析液流动路径,以用于检测所述透析液流动路径内的流体流;
第二流量传感器,所述第二流量传感器在所述透析器下游连接至所述透析液流动路径,以用于检测所述透析液流动路径内的流体流;
第三流量传感器,所述第三流量传感器在所述透析器上游连接至所述血液流动路径,以用于检测所述血液流动路径内的血流;
第四流量传感器,所述第四流量传感器在所述透析器下游连接至所述血液流动路径,以用于检测所述血液流动路径内的流体流;
第一压力传感器,所述第一压力传感器在所述透析器上游连接至所述透析液流动路径,以用于检测所述透析液流动路径内的压力;
第二压力传感器,所述第二压力传感器在所述透析器下游连接至所述透析液流动路径,以用于检测所述透析液流动路径内的压力;
第三压力传感器,所述第三压力传感器在所述透析器上游连接至所述血液流动路径,以用于检测所述血液流动路径内的压力;
第四压力传感器,所述第四压力传感器在所述透析器下游连接至所述血液流动路径,以用于检测所述血液流动路径内的压力;和
药筒的电端子,所述药筒的电端子电连接至所述一次性药筒的第一流量传感器、第二流量传感器、第三流量传感器和第四流量传感器以及所述一次性药筒的第一压力传感器、第二压力传感器、第三压力传感器和第四压力传感器;
所述可重复使用的透析机包括:
第一泵用马达,所述第一泵用马达接合所述第一泵致动器并致动所述第一泵致动器的运转;
第二泵用马达,所述第二泵用马达接合所述第二泵致动器并致动所述第二泵致动器的运转;
第三泵用马达,所述第三泵用马达接合所述第三泵致动器并致动所述第三泵致动器的运转;
所述储罐,所述储罐用于以与所述透析液流动路径流体连接的方式储存透析溶液;
加热器,所述加热器热连接至所述储罐,以用于加热所述储罐中的流体;
温度传感器,所述温度传感器用于测量所述储罐中的流体的温度;
液位传感器,所述液位传感器用于检测所述储罐中的流体的液位;
血液渗漏传感器,所述血液渗漏传感器用于检测所述透析液流动路径中的血液;
氨气传感器,所述氨气传感器邻近所述蒸气薄膜,用于感测从所述过滤器释放的氨气;
静脉血管线压力传感器,所述静脉血管线压力传感器连接至所述静脉血管线,以用于感测所述静脉血管线中的压力;
气泡传感器,所述气泡传感器连接至所述静脉血管线,以用于检测所述静脉血管线中的气态气泡;
夹管阀,所述夹管阀连接至所述静脉血管线,以用于有选择地允许或者阻止血液通过所述静脉血管线的流动;
透析机的电端子,所述透析机的电端子用于电连接至所述一次性药筒的电端子,以用于在所述可重复使用的透析机和所述一次性药筒之间传输电信号;和
处理器,所述处理器被连接至所述第一泵用马达、第二泵用马达和第三泵用马达,以用于控制所述第一泵用马达、第二泵用马达和第三泵用马达的运转,所述处理器连接至所述液位传感器、所述温度传感器、所述血液渗漏传感器、所述氨气传感器、所述静脉血管线压力传感器和所述气泡传感器,以用于监控所述透析机的各传感器,所述处理器连接至所述透析机的电端子,以连接并监控所述一次性药筒的各流量传感器和所述一次性药筒的各压力传感器,并且所述处理器连接至所述夹管阀,以用于控制所述夹管阀的打开和关闭。
2.如权利要求1所述的血液透析系统,其中透析器包括将所述血液流动路径和所述透析液流动路径分开的半渗透膜,并且所述处理器监控所述第一压力传感器、第二压力传感器、第三压力传感器、第四压力传感器并控制所述第一泵用马达、第二泵用马达和第三泵用马达中的相应的泵用马达,以便保持所述半渗透膜两侧的预定压力差。
3.如权利要求2所述的血液透析系统,其中所述处理器将透析器内所述血液流动路径相对于透析液流动路径的所述压力差保持在大约零。
4.如权利要求2所述的血液透析系统,其中所述处理器将透析器内所述血液流动路径相对于透析液流动路径的所述压力差保持在零之上,以提供超过滤。
5.如权利要求1所述的血液透析系统,其中所述泵致动器是由不变形的部件构成的。
6.如权利要求1所述的血液透析系统,其中所述第一泵致动器、第二泵致动器和第三泵致动器包括滑动式叶片构造,其中每个泵致动器是由不变形部件构成的,所述不变形部件包括:具有形成内部侧壁的中央空腔的外壳;偏心地定位在所述空腔内的转子,所述转子在所述转子的外周处具有多个径向排列的槽缝;和叶片,所述叶片可滑动地定位在所述槽缝中以滑入和滑出所述槽缝,以便与所述空腔的内部侧壁密封,从而形成泵送透析液通过所述透析液流动路径的叶片腔室。
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