CN105056324B - 模块化便携透析系统 - Google Patents

模块化便携透析系统 Download PDF

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CN105056324B
CN105056324B CN201510391794.3A CN201510391794A CN105056324B CN 105056324 B CN105056324 B CN 105056324B CN 201510391794 A CN201510391794 A CN 201510391794A CN 105056324 B CN105056324 B CN 105056324B
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modularization
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dialysis system
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CN105056324A (zh
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巴里·N·福尔克森
简·B·兹维尔斯特拉
马克·F·史密斯
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Fresenius Medical Care Holdings Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D61/00Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/24Dialysis ; Membrane extraction
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D61/00Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/24Dialysis ; Membrane extraction
    • B01D61/28Apparatus therefor
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D61/00Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/24Dialysis ; Membrane extraction
    • B01D61/30Accessories; Auxiliary operation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/121General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit interface between cassette and base
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3546Range
    • A61M2205/3569Range sublocal, e.g. between console and disposable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00Ancillary equipment
    • A61M2209/08Supports for equipment
    • A61M2209/084Supporting bases, stands for equipment
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2313/00Details relating to membrane modules or apparatus
    • B01D2313/20Specific housing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2313/00Details relating to membrane modules or apparatus
    • B01D2313/20Specific housing
    • B01D2313/205Specific housing characterised by the shape
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D2313/00Details relating to membrane modules or apparatus
    • B01D2313/20Specific housing
    • B01D2313/208Resilient or flexible housing walls, e.g. bags or foils

Abstract

本发明涉及模块化便携透析系统。本发明涉及模块化且便携的具有改进的功能性的透析单元。在一个实施例中,透析系统包括可拆卸地附着到底座的顶部单元,所述底座包括用于流体存储的储存器。在众多其它特征中,本发明的便携的模块化透析系统具有改进的动力门锁定、区域性泄漏检查、流体处理和使得能够具有改进的模块性的机械设计特征。

Description

模块化便携透析系统
本申请是申请日为2009年10月30日,申请号为200980153428.7,发明名称为“模块化便携透析系统”的申请的分案申请。
交叉引用
本发明依赖于在2008年10月30日提交的美国临时专利No.61/109,834的优先权。本发明还与以下美国专利申请有关:2009年10月7日提交的No.12/575,450、2009年10月7日提交的12/575,449、2009年1月16日提交的12/355,102、2009年1月16日提交的12/355,128、2009年1月12日提交的12/351,969、2008年11月28日提交的12/324,924、2008年9月12日提交的12/210,080、2008年9月25日提交的12/238,055、2008年9月25日提交的12/237,914、2008年10月10日提交的12/249,090和2008年10月3日提交的12/245,397。所有的上述申请在此被引入作为参考。
技术领域
本发明涉及具有改进的结构和功能特征的透析系统。特别地,本发明的透析系统涉及具有改进的模块性、易于实用性和安全特征的便携透析系统。
背景技术
血液透析用于在肾衰竭的情形下从人体移除有毒废物。患者血液经由管子被临时带到身体外面并通过透析器中的至少一个半渗透膜,所述膜可以是一组中空纤维。半渗透膜从透析液溶液分离血液。来自血液的杂质通过膜并主要通过渗透压力进入到透析液溶液中。清洁后的血液然后返回到身体。
利用在医院中安装的设备的标准透析治疗包括两个阶段,也就是,(a)透析,其中有毒物质和渣子(通常为小分子)从血液通过半透膜到透析液体,和(b)超滤,其中血液回路和透析液回路之间的压差,更准确地说,透析液回路中降低的压力,使得水中的血液含量减少预定量。
利用标准设备的透析程序除了需要患者身处透析中心很长时间之外趋于笨重且昂贵。便携透析系统已经发展出来。美国专利No.4,083,777公开一种具有透析器装置的血液透析系统,包含血液和透析液溶液的废物杂质以间接质量传递透析关系通过该透析器装置,用于将废物杂质从血液转移到透析液溶液。所述设备包括用于从患者转移包含血液的废物杂质到所述透析器装置的装置,该透析器装置包括挠弹性管式泵送部分,通过该部分血液被泵送,以及还包括用于将废物杂质被去除的血液返回到患者从而形成血流回路的装置。蠕动泵装置装备有可旋转的泵头组件,该组件包括定位用于绕固定轴转动的底座构件,多个圆周地间隔开的辊子安装在那上面,用于绕平行于底座构件固定轴的各轴独立转动。
美国专利No.4,443,333公开一种用于透析血液的便携系统,其中血液通过交换台,血液接触半透性膜的一侧而透析液接触半透性膜的另一侧,该系统包括:适于连接到血液源并将血液返回到那里的弹性管装置,用于传导血液通过多个站、与所述血液管装置连通的气泡检测器和血块检测器;适于连接到透析液源的弹性管装置,用于传导透析液通过多个站;用于测量和调节透析液流动、压力、温度和电导率的装置;用于保持透析液在低于通过交换台期间的血液的压力的装置;单一电机装置,其输出轴连接到至少两个蠕动泵,一个蠕动泵用于在弹性血液装置中传输血液,另一个用于在弹性透析液管装置中传输透析液;与电机装置和蠕动泵相关联的机构,用于保持透析液流三倍于血液流,每个蠕动泵具有拱式的内表面;血液泵,其具有与拱式的内支撑表面相关联以捕获血液管装置在其间的至少一个辊;透析液泵,其具有与所述内拱式支撑表面相关联以捕获所述透析液管装置在其间的单一的辊,蠕动血液泵的促动由于辊而导致血液管装置中的血液平稳的层流,蠕动透析液泵的促动由于由导致弹性透析液管装置变形和返回的单一辊产生的真空而导致透析液流动;和控制机构,其可操作地连接到血液泄漏检测器和气泡检测器以及电机装置和透析液流动、压力、温度和电导率测量装置,用于响应压力或者温度或者电导率测量值位于预选范围之外而选择性停止透析液辊从而停止透析液运动通过透析液管装置和通过交换台,同时保持血液流动,并用于响应来自血液泄漏检测器或者气泡检测器的信号而同时停止所有的辊子以停止整个系统并停止泵送。
美国专利No.6,168578公开一种便携肾透析系统,其包括具有安装在其上的排放袋的带。泵同样安装在带上并耦合在用户和排放袋之间。泵适于在接收到排放信号时将流体从用户泵送到排放袋。进一步提供的是压力开关,用于检测排放袋何时满。控制机构用于仅当装置未检测到排放袋是满的才传递排放信号到泵。由NxStage制造的称作System One的便携透析系统是传统的便携血液透析系统的另一个例子。
上述便携透析系统受制于某些缺点。第一,它们不是充分模块化的,从而有碍系统的易安装、移动、装运和维修的方便性。第二,所述系统不是足够简化以便患者可靠、正确地使用的。系统的分界面和利用一次性部件的方法受制于患者在使用中的错用和/或错误。对于真正有效的便携透析系统,它应当容易地且方便地由并非健康护理专家的个体使用,可处理的输入和数据输入受限以足以防止不正确的使用。
因此,期望具有一种便携透析系统,其具有配置来优化系统的模块性的结构设计,从而使得该系统易于设置、移动、装运和维修。进一步期望具有系统分界面,通过该分界面患者输入数据或者部署一次性部件,所述分界面配置来防止使用错误并充分限制以防止不正确的使用。
发明内容
本发明涉及一种模块化透析系统,包括:控制器单元,其具有第一外部壳体,该第一外部壳体具有前侧面、后侧面、左侧面、右侧面、顶部侧面和底部侧面,其中所述前侧面包括配置来提供到所述控制单元内的内部体积的通路的门;储存器单元,其具有第二外部壳体,该第二外部壳体具有前侧面、后侧面、左侧面、右侧面、顶部侧面和底部侧面,其中所述前侧面包括配置来提供到所述储存器单元内的内部体积的通路的门;其中所述第一外部壳体的底部侧面适于牢固地并可移除地附着到所述第二外部壳体的所述顶部侧面,并且其中当所述第一外部壳体牢固地并可移除地附着到所述第二外部壳体时,所述控制器单元自动地布置为与所述储存器单元电连通。
任选地,第一外部壳体的底部侧面包括电触垫,第二外部壳体的顶部侧面包括多个电销。任选地第一外部壳体的底部侧面包括多个电销,第二外部壳体的顶部侧面包括电触垫。当触垫对齐并布置为与多个推销电连通时,控制器单元自动布置为与所述储存器单元电连通。
任选地,当所述第一外部壳体牢固地并可移除地附着到所述第二外部壳体时,控制器单元自动布置为与所述储存器单元数据连通。第一外部壳体的底部侧面包括具有至少一个LED发射器和至少一个LED接收器的第一红外通信端口,第二外部壳体的顶部侧面包括具有至少一个LED发射器和至少一个LED接收器的第二红外通信端口。当第一红外通信端口对齐并布置为与第二红外通信端口数据连通时,控制器单元自动布置为与所述储存器数据连通。
任选地,在所述控制器单元之内的内部体积容纳歧管、钩子和围绕歧管的保护罩。配置为提供到所述控制器单元内的内部体积的通路的门具有内表面,该内表面包括多个泵靴、锁闩和具有当所述门闭合时伸入到所述内部体积中的侧面的外壳。当门闭合时,所述锁闩机械地接合所述钩子。模块化透析系统进一步包括配置为促动电机以施加运动力到所述钩子的控制器,运动力的所述施加导致所述门通过在90-110磅范围内的力闭合。模块化透析系统进一步包括机具有第一状态和第二状态的械释放按钮,其中,在所述第一状态按钮能够机械地接合所述钩子,其中在所述第二状态按钮不能机械地接合所述钩子。
在另一个实施例中,本发明涉及一种模块化透析系统,包括:控制器单元,其具有第一外部壳体,该第一外部壳体具有前侧面、后侧面、左侧面、右侧面、顶部侧面和底部侧面,其中所述前侧面包括配置来提供到所述控制器单元内的内部体积的通路的门;储存器单元,其具有第二外部壳体,该第二外部壳体具有前侧面、后侧面、左侧面、右侧面、顶部侧面和底部侧面,其中所述前侧面包括配置来提供到所述控制器单元内的内部体积的通路的门,其中所述顶部侧面具有倾斜表面,该倾斜表面具有多个通道,该通道与至少一个泄漏检测器流体连通;以及其中所述第一外部壳体的所述底部侧面适于牢固地并可移除地附着到所述第二外部壳体的所述顶部侧面。
任选地,第一外部壳体的底部侧面包括电触垫,第二外部壳体的顶部侧面包括多个电销。当触垫对齐并布置为与多个推销电连通时,控制器单元自动布置为与所述储存器单元电连通。第一外部壳体的底部侧面包括具有至少一个LED发射器和至少一个LED接收器的第一红外通信端口,第二外部壳体的顶部侧面包括具有至少一个LED发射器和至少一个LED接收器的第二红外通信端口。当第一红外通信端口对齐并布置为与第二红外通信端口数据连通时控制器单元自动布置为与所述储存器单元数据通信。
任选地,在所述控制器单元之内的内部体积罩住钩子,配置来提供到所述控制器单元内的内部体积的通路的门具有内表面,该内表面包括锁闩。模块化透析系统进一步包括配置来响应用户输入促动电机以施加运动力到所述钩住的控制器,所述运动力的施加导致所述门通过90-110磅范围内的力闭合。模块化透析系统进一步包括具有第一状态和第二状态的机械释放按钮,其中,在所述第一状态,按钮能够机械地接合所述钩子,其中在所述第二状态,按钮不能机械地接合所述钩子。
这些和其它的实施例将在关于附图的详细描述部分更加详细地进行描述。
附图说明
参照下面的附图更加详细地描述本发明德文实施例,其中:
图1是本发明的透析系统的前视图;
图2是透析系统的视图,其示出系统的模块性;
图3是门打开的情形下透析系统的后部的视图;
图4是具有打开的门和U形锁闩的透析系统的一个实施例的前视图;
图5是本发明的一个实施例中顶部单元的内部结构的视图;
图6是本发明中实施的基于标尺的流体平衡中的部件的图形;
图7a是具有一体的标尺的储存器的侧面透视图;
图7b是弯曲组件的侧面透视图;
图8是本发明中实施的示例性图形用户界面的前视图;
图9a是具有设计在那里的泄漏通道和泄漏检测器的底部单元的顶部表面的第一视图;
图9b是具有设计在那里的泄漏通道和泄漏检测器的底部单元的顶部表面的第二视图;
图9c是具有设计在那里的泄漏通道和泄漏检测器的底部单元的前视图;
图10是具有条形码读取器的透析设备的实施例的侧面;
图11a是门组件的一个实施例的示意图;
图11b是门释放的一个实施例的示意图;
图12是描述具有模块化的可动的工作空间的透析系统的顶部的图形;
图13是附着到便携透析系统的上单元的锁闩的一个实施例的侧面透视图;
图14是具有相配的锁闩机构的便携透析系统的底座单元的一个实施例的第一侧面透视图;
图15是具有相配的锁闩机构的便携透析系统的底座单元的一个实施例的第二侧面透视图;
图16是在便携透析系统的一个实施例中实施的电和通信连接的顶视图;
图17a是具有标出的示例性尺寸的便携透析系统的一个实施例的顶视图;
图17b是具有标出的示例性尺寸的便携透析系统的一个实施例的前视图;
图18a是具有接收腔和对齐销的底座单元的一个实施例的视图;以及
图18b是具有脚垫的顶部单元的一个实施例的视图。
具体实施方式
尽管本发明可以以许多不同形式进行实施,但是为了便于理解本发明的原理,现参照在附图中示出的实施例并且特定的语言将用于描述所述实施例。然而,应当理解,并不打算因此限制本发明的范围。本发明所涉及的技术领域的技术人员通常能够想到的在描述的实施例中的任何变化和进一步修改以及如在此描述的本发明的原理的任何的进一步应用。
“持续时间”及其变体是指从开始到结束的规定治疗的时间段,不管治疗是否因为病情治愈而结束或者治疗由于任何原因而中止。在治疗的持续时间中,可以规定多个治疗疗程,在所述疗程中对对象执行一个或多个规定的刺激。
“疗程”是指作为规定的治疗计划的一部分对对象执行一剂刺激的时间。
术语“和/或”是指所列要素的一个或者全部,或者所列要素的任何两个或多个的组合。
术语“包括”及其变体在出现在说明书和权利要求中的情形下并不具有限制的含义。
除非另有特别说明,“一”、“所述”、“一个或多个”和“至少一个”是可互换使用的并且指一个或超过一个。
对于包括离散的步骤的在这里公开的任何的方法,所述步骤可以以任何可行的顺序执行。并且,根据需要,两个或多个步骤的任何组合可以同时执行。
同样地,在这里,通过端点的数值范围的引用包括包含在该范围内的所有数字(例如,1至5包括1、1.52、2、2.75、3、3.80、4、5等)。除非另有特别说明,在说明书和权利要求中使用的表示部件数量、分子重量等的所有数字应当理解为在所有情形下都可以被术语“大约”修饰。相应地,除非另有相反说明,在说明书和权利要求中提出的数字参数都是近似值,其可以取决于本发明寻求获得的期望属性而变化。最起码,并且不是试图限制权利要求的范围的等同原则,每个数字参数应当至少根据所代表的明显的位数以及进行普通的取整技术进行理解。
尽管阐明本发明的宽的范围的数值范围和参数是近似值,但是在特定例子中提出的数字值被尽可能精确地汇报。但是,全部的数字值固有地包含在它们的各测试测量中发现的标准偏差所导致的必要的一定范围。
本发明涉及模块化并且便携并具有改进的功能的透析单元。参照图1和2,在一个实施例中,透析系统100、200包括可拆卸地贴附到底座202的顶部单元101、201,该底座202包括用于流体储存的储存器122、222。顶部单元101、201,其也称为主单元或者控制器单元,包括图形用户界面114、214、泵送单元和具有动力锁定和机械备用机构的门110、210,如下面进一步讨论的。到顶部单元101、201的第一侧的是带扣105,用于可拆卸地贴附透析器103。到顶部单元101、201的第二侧的是吸附剂盒锁定底座104、204,用于可拆卸地贴附吸附剂盒107。应当认识到,带扣105、血液过滤器103、吸附剂盒锁定底座104和吸附剂盒107可以定位在顶部单元101的相同的侧面上,如图3所示。在任一情形中,底部单元具有相对于顶部单元足够更大的区域以使得在顶部单元的任一侧上都形成架子以保持吸附剂盒,以保持注入液罐,以俘获任何的溢出和/或连通任何泄漏到泄漏检测器。
在透析器103和门110之间是注射器泵190形式的抗凝剂泵。任选地,顶部单元101可以包括瓶保持器190,其具有锥形底座以接收倒置的瓶子在瓶保持器壳体内。注入液连接至血液泵的入口、血液泵的出口或透析器的出口(血液侧)。注入液线路还可以“螺纹”通过气泡检测器以传感抗凝剂是否/何时空了或者阻塞了。
本发明的透析系统实现具有超过现有技术的实质性改进的功能和操作参数。顶部单元是在大约20-40磅的范围内,更特别地30磅,并且底部单元是在大约15-30磅的范围内,更特别地22磅,从而比现有技术的系统更加轻。顶部单元是在大约1-4立方英尺的范围内,更特别地2.3立方英尺,底部单元是在大约1-4立方英尺的范围内,更特别地2.8立方英尺,从而具有比现有技术的系统更小的体积。
在一个实施例中,参照图17,顶部单元1701,其包括用户界面和控制器,具有与底座单元1702相同深度,但是不同的长度和高度,其包括集成有标尺的储存器。在这个示例性实施例中,顶部单元1701和底部单元1702都具有在10-30英寸范围内,更优选大约19英寸的深度D。在这个示例性实施例中,顶部单元1701具有在6-20英寸范围内,更优选地大约14英寸的长度Lt,而底部单元具有在14-40英寸范围内,更优选27英寸的长度Lb。在这个示例性实施例中,顶部单元1701具有在7-21英寸范围内,更优选地大约14.5英寸的高度Ht,而底部单元具有在3-11英寸范围内,更优选7英寸的高度Hb。
底座单元1702可进一步通过两台肩1704限定,每个台肩沿着底座单元1702的长度从中心地定位的顶部单元1701的侧面向外延伸。顶部单元优选地定位在底座单元1702的中心,如通过长度Lb测量的。相应地,台肩1704可以限定为具有在4-10英寸范围内,更优选地大约7英寸的长度。从底座单元1702的表面向上延伸的是唇部1703,在底座单元的表面那里台肩1704物理接触顶部单元1701,所述唇部1703限定一表面,单元1701在该表面上对齐和布置。唇部1703围绕顶部单元1701的底座邻接,具有与顶部单元1701相同的长度和深度,具有限定为Ht2和Ht之间的差的高度。在一个实施例中,唇部高度是在0.1-3.5英寸范围内,更优选地0.6英寸。系统的总高度Ht3是在10-35英寸范围内,更优选地22英寸。
限定顶部单元1701和底座单元1702的外部壳体结构可以特征为矩形平行多边体、长方体或者箱体,每个具有四个侧面一顶部和一底部。在示例性实施例中,对于顶部单元1701和底座单元1702而言,四个侧面的两个具有相同高度、长度和深度,该两个表面的每个具有外表面和内表面,而顶部和底部结构具有相同高度、长度和深度,顶部和底部结构的每一个具有内表面和外表面。
应当认识到,如图1、2、17a和17b所示的系统构型是示例性的,而非限制性的。例如,如图3所示,顶部单元301可定位在底座单元302的一个侧面上(形成非对称的底座),与相对于底座单元302的整个长度中心地定位在底座单元302的顶部上(形成对称的底座)相反。而布置顶部单元301在底座单元302的一个侧面上具有布置所有的管子连接和消耗品在系统的相同的侧面上的优点,吸附剂盒317和透析器313不必聚集在一起从而使得设备更难以使用。
透析系统使用比现有技术的系统更少的水。传统的系统每次治疗使用大约120公升。在一个实施例中,本系统使用3-8公升之间,更特别地5-6公升之间的水。而且,所述系统并不要求家庭排放、供应连接或者单独的出口来解决过多的水。
此外,在一个实施例中,本发明使用多通道吸附剂系统,如在XCORP212中公开的,其在此被引入作为参考。相应地,所述系统并不要求具有反渗透系统的单独的净化水输入,相反,可以使用一般的自来水,然后利用吸附剂系统提纯。
而且,系统设计更紧凑,需要低的功率(在峰值仅300W,在操作期间50-100W),不需要用于充灌或者移动单独的流体袋以及一体的泵。所述装置利用20-600Qb(ml/min)的血流范围、50-500Qd(ml/min)的透析液流进行操作。体积精度精确性同样低于+/-30ml/hr。
如图2所示,透析系统是模块化的。在一个实施例中,顶部单元201可以与底部单元202物理分离。顶部单元201包含系统的主要电子元器件,包括图形用户界面、控制器以及一体形成到自包含壳体中的泵。更大、更笨重的底部单元202包含储存器222。系统电子元器件从储存器的分离允许便携透析系统分离为多个单元以便安装、维修和移动,每个子单元易于搬运、包装和传送。该设计特别形成的部件的尺寸以便于通过UPS或者其它的送货上门递送商装运。它进一步提供产品成长的灵活性。例如,如果对控制器单元或者单独地对储存器进行改进(例如减少流体体积或者体积标尺测量中的变化),现有用户仅需升级两个部件部分的一个,而非两个。类似地,如果两部件的仅一个坏了(例如,泵烧坏了),用户仅需要送一个去修理或者购买两部件中的一个。
为了使得能够实现上面描述的模块性,本发明的实施例采用锁闩机构,该锁闩机构在第一构型牢固地附着底部单元202到顶部单元201并能够操控以从顶部单元201可移除地拆卸底部单元202。即使两系统可以不用锁闩而简单地一个堆叠在另一个顶部,但是锁闩的存在和使用也可减少意外断开的可能。而且,当锁定在一起时,该装置更容易移动。锁闩机构优选地不使用工具并利用在顶部部件和底部部件上的阳/阴配合连接而简单完成。进一步优选地,锁闩机构设计以保证顶部和底部部件之间的牢固对齐,从而使得能够使用电子部件(例如在顶部单元的底部和底部单元的顶部上的暴露的电子连接器,如下面进一步描述的),其在当各个单元适当对齐时自动接触并完成电力回路。这允许使用单一的电源和简单的连接/断开。
参照图14,底部单元1402具有四个侧面1405a、1405b、1405c、1405d、底座、顶部表面1406和可经由第一侧面1405d接近的储存器1422。底部单元1402进一步包括在它的顶部表面1406上的多个锁闩配合结构1420。在一个实施例中,本发明包括两个锁闩配合结构1420a、1420b,所述两个锁闩配合结构1420a、1420b相对于底部单元1402的长度中心地定位以保证均匀的重量分配。第一锁闩配合结构1420a优选地定位为从侧面1405d测量具有等于底部单元1402的宽度的三分之一的距离。第二锁闩配合结构1420b优选地定位为从侧面1405b测量具有等于底部单元1402的宽度的三分之一的距离。
锁闩机构,如图15所示,包括金属框架1501,其利用例如螺栓、螺钉或者其它的紧固件1502牢固地紧固到底部单元1505的顶部表面。框架1501支撑突起或者长型构件1503,该构件1503可以柔性地插入到相应锁闩中并从相应的锁闩移除。
为了牢固地并可拆除地附着底部单元到顶部单元,顶部单元包括互补的机械滑动锁闩,所述锁闩牢固地附着到顶部单元的底座。在一个实施例中,顶部单元的底座包括第一锁闩,其相对于顶部单元的长度优选地定位在顶部单元的中心,并且从第一侧面测量具有等于顶部单元的宽度的三分之一的距离。底座还包括第二锁闩,其相对于顶部单元的长度优选地定位在顶部单元的中心,并且从第二侧面测量具有等于顶部单元的宽度的三分之一的距离,所述第二侧面与第一侧面相对并平行。
如图13所示,顶部单元包括具有滑动金属平面底座1315的锁闩1300。导轨1330可滑动地接合顶部单元的底部表面,所述顶部单元的底部表面具有配合件以保持导轨1330在适当的位置。锁闩1300具有两个锁闩凸片1315,其适于滑入和滑出物理地附着到底座单元1406的顶部表面的配合结构。
附着到顶部单元的锁闩1300与底部单元1406的顶部表面上的锁闩配合结构1420a、1420b配合。在操作中,当滑动锁闩1300处于第一位置时,顶部单元将不会有效地配合在底座单元的顶部上或者对齐底座单元,因为滑动锁闩1300不会正确地物理配合锁闩配合结构1420a、1420b。为了制备用于牢固布置到底座单元1406的顶部表面上的顶部单元,滑动锁闩在定位在顶部单元的底部上的构件保持结构内运动并布置到第二位置中。
在第二位置,锁闩1311的手柄将伸出,从而远离锁闩配合结构1420a、1420b移动凸片1315并允许顶部单元正确地定位在底座单元上。参照图18a和18b,具有滑动锁闩1880的顶部单元1801通过在顶部单元1801的底部上的四个小的橡胶脚部或者脚垫1840对齐到底部单元1802,所述四个小的橡胶脚部或者脚垫1840配置或者适配来合适地(snugly)并牢固地配合到位于底部单元1802的顶部上的每个拐角附近的四个腔或者袋1830中。此外,顶部单元1801可以利用在底座单元1802的顶部表面上的对齐销1860或者突起精确对齐到底部单元1802,所述对齐销1860或者突起配置或者适配为牢固地并合适地配合到顶部单元1801的底部表面上的相应腔1890中。底部单元还具有如上面描述的锁闩配合结构1863。
对齐橡胶脚部1840到腔1830中以及对齐销1860到腔1880中保证在顶部单元1801上的锁闩1880可以容易地对齐和锁定到锁闩相配结构1863,而没有过多的试验和错误。一旦对齐,通过滑动锁闩1880到锁闩配合结构1863中,锁闩1880配合锁闩配合结构1863,从而在两单元之间产生紧配合。回过来参照图13和14,为了解锁,锁闩手柄1311被拉动或者否则被操控,从而从底座单元缝槽1420a、1420b释放凸片1315,并允许顶部上单元从底部下单元提升。
而且,为了使得能够实现上面描述的模块性,本发明的实施例还采用电和通信连接机构,其在第一构型中牢固地建立底部单元和顶部单元之间的电通信和/或数据通信连接,并且在第二构型中,终止底部单元和顶部单元之间的电通信和/或数据通信连接。
参照图16,当顶部单元位于底部单元上时,顶部和底部单元之间的电连接得以产生。这些连接通过非接触红外通信端口1603和推动-销电力端口1603进行,所述非接触红外通信端口1603和推动-销电力端口1603一体地形成到板1602中并利用紧固件1601牢固地附着到底部单元1605的顶部表面。应当认识到,顶部单元的底部表面然后将包括与推动-销适当对齐的电触垫。应当进一步认识到,推销和触垫的位置可以反过来,从而布置推销在顶部单元的底部表面上,布置触垫在底部单元的顶部表面上。
在一个实施例中,高强度电流电力连接通过布置六个弹簧加载销为与触垫电接触而产生,所述触垫集成到顶部单元的底部表面中。三个销是用于+24伏特直流电流的,三个销是用于接地的。在一个实施例中,销或者探针具有以下特征:a)0.175英寸的最小中心,b)15安培(连续的)的电流等级,c)在0.06英寸-0.067英寸的移动中6.2oz-9.0oz的范围内的弹簧力,d)小于10毫欧的典型电阻,e)在0.09-0.1英寸范围内的最大移动,f)在0.06-0.067英寸范围内的工作移动,g)镍/银制成并镀金的筒,h)不锈钢弹簧(任选地镀金),i)由完全硬度的铍铜制成并镀金的活塞;和j)任选地不锈钢偏压球。销的弹簧力有助于通过吸收弯曲或者其它变形而防止破坏。应当认识到,术语电销代表能够传输电力的任何突起,电触垫代表能够接收电销的任何的表面。
非接触红外通信端口1603采用两个LED发射器和两个LED接收器,它们与顶部单元的底部表面上的两个LED发射器和两个LED接收器对齐并通信。发射和接收端口之间的距离小于0.3英寸。在底部单元的顶部表面和顶部单元的底部表面上,四个LED单元分为两对,一个控制对(包括一个发射器和一个接收器)和一个安全对(包括一个发射器和一个接收器)。当顶部和底部单元正确对齐时,这些端口布置为数据通信。在一个实施例中,LED发射器是由GaAlAs双异性技术制造的870nm的高速红外发射二极管。LED发射器是高速二极管,具有下面的特征:a)超高的辐射功率,b)低前向电压,c)适合高脉冲电流操作,d)大约17度的半强度角,e)大约870nm的峰值波长,f)大约5V的反向电压,g)大约100mA的前向电流,h)大约200mA的峰值前向电流,i)大约0.8A的浪涌前向电流,j)大约190mW的功率耗散,k)大约100摄氏度的结区温度,和l)-40到85摄氏度的操作温度范围。应当认识到,非接触红外通信端口可以以任何功能方式跨过底部单元的顶部表面或者顶部单元的底部表面分布。应当进一步认识到,在此可以实施本领域普通技术人员已知的任何其它的通信端口和结构。
在一个实施例中,LED接收器是具有特快的响应时间、大约0.25平方毫米的发射敏感面积和大约15度的半敏感度角度的高速硅光电二极管。
LED接收器具有以下特征:a)大约60V的反向电压,b)大约75mW的功率耗散,c)大约100摄氏度的结区温度,d)-40到85摄氏度的操作温度范围,e)大约1V的正向电压,f)60V的最小击穿电压,和g)大约1.8pF.的二极管电容。
回过来参照图1、2和3,在控制器单元101、201的顶部是手柄211、311和可用架子112、212形式的工作空间。位于系统的上泵送部分的手柄直接连接到系统的内部结构或者框架并且不仅仅是围绕顶部单元101、201的外部塑料模制、壳体或者表皮的延伸。到系统的内部框架的直接连接允许利用手柄以安全并且可以可靠地处理装载的方式改变系统位置,特别是当仪器处于通过六公升水(加入大约40磅)的操作中时。
参照图5,在一个实施例中,顶部单元501包括内部金属外壳、框架或者壳体510,电子元器件、控制器及其他顶部单元部件包含在其中并包含到其上。内部外壳510包括水平凸出的臂507,其延伸到顶部单元501的后侧。大致水平的顶部架子505包括至少一个手柄520,其一体形成到顶部架子结构505、底座支架530和竖直臂506中,从而产生单一的邻接的金属或者模制塑料件。底座支架530在顶部单元501的前面牢固地附着到内部外壳510,竖直臂506在点508利用螺丝牢固地附着到凸出臂507。通过牢固地附着架子505和手柄520结构到顶部单元501的内部外壳510,可以避免布置大重量的负荷在手柄和顶部单元的外部或者外面壳体之间的连接点处通常会发生的潜在损坏或者破坏。
同样通过铰链565附着到内部框架或者外壳510的是金属门562,其形成门110的内部框架,如图1所示。门562牢固地附着到板561,板561是内部框架510的一部分。结构563和572是保持内部电机和滑轮组件的结构,和/或代表内部电机和滑轮组件的突起。从框架510的后部延伸的突起583用于连接各种电子部件,包括电力输入模块和USB连接582。
控制器单元的顶部或者架子505是平的,并具有使得它非常适于提供存储的侧壁或者临时工作表面。参照图12,在一个实施例中,用于该系统中的一次性物品1206以预装在托盘1205上的包裹进行装运。托盘1205布置在控制器单元1201工作空间的顶部,从而允许基于操作和管理需要的一次性物品,这对于家庭用户是特别重要的。控制器单元1201是防水等级的,以使得在液体溢出的情形下,它不会浸入并损坏顶部控制器单元1201。
控制器单元1001的另一个结构特征示出在图10中。优选地,单元1001具有内嵌的暴露的读取器,例如条形码读取器或者RFID标签读取器,其可以用于读取一次性部件上的编码或者标签。操作上,用户可以优选地通过读取器扫一次性部件上的编码/标签。对用户的提示可以通过初始GUI透析安装步骤实行,其指导用户扫通过读取器的每个一次性部件。
通过那样做,读取器获得关于一次性物品的识别信息,将该识别信息传输到存储在存储器中的内部表,比较识别信息与内部表的内容,并验证(或者不验证)存在正确的一次性部件(特别是用于透析液中的添加剂)。内部表的内容可以通过手动输入一次性物品的身份和数量或者通过远程访问详细列出一次性物品的身份和数量的处方而产生。该验证步骤至少具有两个益处。第一个是保证用户在他或者她的物品中具有所有要求的部件,第二个是保证正确的部件将被使用(不是伪造的或者不合适的一次性物品)。
在另一个实施例中,安装在顶部单元侧面上的读取器1005是专门的多功能红外照相机,该红外照相机在一个模式下提供读取条形码的能力,在另一模式下检测注入液容器的液位变化。照相机发射反射离开液面的红外信号。反射信号通过照相机的红外接收器接收并利用处理器处理以确定液面的弯月面的位置。在一个实施例中,照相机可以确定和监测液面的变化到0.02毫米的分辨率。在一个实施例中,照相机是1.3兆(mega)像素的单一芯片的照相机模块,具有以下特征的一个或多个:a)1280H x 1024V有效像素,b)3.0μm像素大小,c)1/3英寸光学格式,d)RGB Bayer滤色器阵列,e)集成的10-比特ADC,f)集成的数字图像处理功能,包括缺陷修正、透镜阴影修正、图像缩放、去马赛克、锐利、伽马修正和色空间转化,g)嵌入式照相机控制器,用于自动曝光控制、自动白平衡控制和背光补偿,h)可编程帧频和输出降级功能,i)高达15fps的SXGA逐行扫描,j)小功率的30fps的VGA逐行扫描,k)8位的并行影像接口,1)两缆线的串行控制接口,m)芯片上PLL,n)从2.4-3.0V的模拟电源,o)单独的I/O电源,p)集成电力管理,具有电力开关,和q)24针的屏蔽插座选择。在一个实施例中,照相机是由ST Microelectronics制造的型号为No.VL6624/VS6624的1.3兆像素的照相机。
透析系统的顶部或者底部单元还优选地具有电子接口,例如以太网连接或者USB端口,以使得能够直接连接到网络,从而方便远程处方验证、顺从警戒及其他远程维修操作。USB端口允许直接连接到附件产品例如血液压力监视器或者血细胞容量计/饱和监视器。接口是电隔离的,从而保证患者安全,而不管接口装置的质量如何。
顶部单元的前面具有图形用户界面114,其提供给系统100简单的用户界面。在家庭设置中,装置易于使用是重要的。颜色和触屏的最大使用非常适于该应用。触屏允许多用户输入构型,提供多语言能力,并可以易于在晚上看到(特别地,具有亮度控制和夜视颜色)。GUI进一步包括用于在操作过程中自动闭合、打开和锁定门的特征。在一个实施例中,GUI打开门到第一锁闩位置,然后用户必须按压物理的开门按钮以完全打开门。在另一个实施例中,装置具有手动超驰控制,其允许用户打开门(例如通过按压开门按钮两次或者用特别大的力按压开门按钮)以手动打开门。参照图8,优选地,在GUI800附近是单一的机械按钮805,具有发光的可视指示,其如果被促动则通过一般的功能(例如停止系统)提供中心停止按钮,而不管操作状态如何。
参照图1,储存器系统102具有门118,该门当被拉动时使得储存器122滑出以允许操作该储存器。储存器容积通过标尺系统进行监测。基于标尺的液体平衡600,如在图6中,更特别地图7a和7b中描述的,与储存器一体形成并提供精确的流体移除数据并使得能够实现精确的平衡计算,从而防止由于液体不平衡导致的血压过低或者其它疾病。集成标尺与储存器并完全包裹它们提供更稳定的系统。
参照图7a,储存器系统内部结构700被示出。金属的内部框架720包括两个侧面721、后部722和打开的面对的前部723和底座724。内部结构或者框架被示出为没有外部壳体,如在图1中元件102所示。标尺718集成到储存器内部结构700中。标尺718的底部表面715包括金属表面或盘,其与标尺718其余部分一起从外部储存器壳体(在图1中如102所示)通过四个弯曲部705悬垂。在标尺的底部表面715的下面优选地定位加热垫,例如正方形、矩形、圆形或者其它的形状表面,其能够随着加热而温度升高并传导升高的温度到表面715。能够施加场并利用场的变化测量电导率的电导率线圈770集成到底座表面715中。相应地,当储存袋(未示出)布置在底部表面715上,它可以由加热垫加热,并且因为它与线圈770接触,它的电导率可以被监测。
侧面721的内表面包括多个导轨、长型构件或者突起719,其用于固定、保持、包住或者附着一次性储存袋安装表面,例如塑料件710,储存袋可以附着到该件710。具体地,定位在表面715上的储存袋可以具有附着到集成到件710中的导管771的出口。安装在标尺表面718的四个拐角的每一个中的是弯曲部705,每个弯曲部包括霍尔传感器和磁体。
参照图7b,弯曲部705包括多个附着点761,在那里弯曲部固定到外部储存器壳体。弯曲部进一步包括磁性的主体762,例如两个磁体,和霍尔传感器764。弯曲部705的底座767附着到标尺718的顶部表面715。当标尺718由于重量装载的施加而位移时(例如当储存袋用透析液充灌时,袋挤压在表面715上,从而向下拉动标尺718),弯曲部705,其在一端连接到标尺而在另一端连接到外部壳体,将折曲,并且安装在弯曲部705的一端上的磁体762将借助磁性的主体762产生的磁场的变化而跟踪该变化。霍尔传感器764检测磁场强度的变化。本领域普通技术人员将理解如何将传感到的该磁场变化转变为施加的重量装载的测量。
一次性部件例如透析器103、吸附剂盒107和注入液以位于系统外部但是易于接近的方式布置允许利用多个尺寸的吸附剂盒、透析器和注入液混合物,从而给予系统使用和适用性的更大的灵活度。参照图3和9,一次性部件,特别地完全一次性的血液和透析液回路,预先包装成套件(其包括透析器、歧管、管子、储存袋、氨传感器和其它的部件),然后通过开口顶部单元301的前门303(如上面讨论的)、安装透析器313和安装歧管304以使得保证对齐抵靠非一次性的部件例如压力传感器和其它的部件而进行使用。集成到前门303的内表面中的多个泵靴使得一次性部件的装载更加容易。歧管仅需要被插入,不需要泵管子来在辊子和靴305之间螺纹连接。这样包装的简单的方法使得一次性物品的装载和系统的清洁容易。它还保证如图11所示的流动线路正确地配置并易于使用。在操作中,顶部单元301通过储存器322附着到底部单元302。
前门大打开(大约100度),用于装载一次性物品。使得门大打开有利于歧管装载并易于清洁设备的面和门内部。使得门闭合并盖住装置的运动部件使得更安全并更稳定,其对于家庭使用是特别重要的。此外,使得前门罩住显示器节省空间并加强这样的重要点:该装置不会被操作,除非一次性物品就位并且门闭合。门提供歧管及其泵送部分上必要的梗塞力。门还包含触屏、声音警报和在门的面上的手动停止按钮。
在一个实施例中,门通过步进电机保持在完全闭合的位置。当门准备好完全闭合或者打开时,该电机经由用户界面进行操作,特别地,通过用户按压按钮而进行操作。为了保证通过门和泵靴在歧管结构上布置正确的压力,优选具有电子机构,通过该电子机构门闭合并且足够的闭合门的力得以产生。在一个实施例中,产生90-110磅的闭合门的力。
参照图1la,示出电力门闭合机构1100的一个实施例。步进电机1106机械地接合丝杠1116,以使得当被控制器促动时,步进电机1106使得丝杠1116转动,结果导致杆1118施加运动力到钩子。位于构件1140下面的钩子用以锁闩到U形锁闩1130上,并且当被拉动、转动或者否则向着步进电机1106向内运动时,拉动U形锁闩1130进一步闭合,从而施加必要的闭合门的力。钩子物理接合杆1118并能够操作以拉动U形锁闩1130紧紧地闭合或者松弛地接合U形锁闩1130。通过安装支架1105,电力闭合系统安装并保持在适当的方向上。
操作上,用户关闭门足以接合在门上的U形锁闩410,钩子450位于控制器单元的内部体积的内部,如图4所示。用户然后优选通过机械按钮或者图形用户界面图标向便携透析设备表明关闭门的期望,所述机械按钮或者图形用户界面图标当被按压时发送信号到控制器,控制器相应地促动步进电机1106。步进电机1106施加运动力到钩子450,钩子然后拉动接合的U形锁闩1130、410紧紧地闭合。在一个实施例中,控制器监测通过电机施加的扭矩力,并且当它达到预定极限时,停止步进电机。在另一个实施例中,紧邻丝杠定位的霍尔装置传感丝杠的延伸并确定丝杠的运动范围。如果丝杠已经在产生更大闭合门的力的方向充分运动,霍尔传感器传递信号到控制器以停止电机。或者,传感器经常地传输表征丝杠延伸的信号,该信号然后由控制器译码以确定是否已经施加足够的运动力,以及步进电机是否应当被停止。在这些实施例的任一中,如果电机超过扭矩、预设距离被超过,或者门在预定时间内没有达到它的完全闭合的位置,控制器可以促动电机以停止和反向到完全打开的状态。控制器还可以产生可视和/或可听的警报。
当用户希望打开门时机械按钮或图形用户界面图标被促动,发送信号到控制器,控制器相应地反向促动步进电动机1106。钩子然后变为与U形锁闩松接合。机械释放按钮1107然后被挤压以从U形锁闩脱离松接合的钩子。
除提供必需的闭合力之外,该电力门闭合机构具有几个重要特征。第一,它设计来避免在门中发生阻塞以及遭受有力的门闭合力。参照图4,歧管由边缘保护罩围绕,如果障碍物例如人的手指或者不适当安装的一次性物品位于门和顶部单元的底座板之间,该保护罩防止门锁闩接合顶部单元上的锁闩接收器。门405包括金属外壳425附着到其上的内表面406。在一个实施例中,门405的内表面406的顶部表面牢固地附着到外壳425的外表面。外壳425大致矩形并限定具有四个侧面407和底座408从而产生内部体积的腔。腔向着透析系统400的歧管结构430开口并包围和围绕歧管结构430和保护罩440,保护罩优选地为在它的顶部和侧面围绕歧管结构430的塑料遮蔽体。附着到底座408的表面的是泵靴415和至少一个U形状的锁闩410,所述锁闩410向着后板伸出。集成在保护罩中并延伸处保护罩的是钩子450,该钩子配置为牢固地接合和脱离U形状的锁闩410。如果门正确闭合并且没有东西夹在门和保护罩之间,那么U形状的锁闩将被电力门锁定钩子机构机械地勾住。如果在门通路中发生阻塞,金属外壳425将不能延伸到顶部单元的内部体积中(并包围保护罩),因此,U形状的锁闩将不能接合钩子,从而防止当发生阻塞时机械地勾住并意外地电力闭合门。
第二,机械释放按钮1107只能在当电力闭合门的力已经通过步进电机的反向运动而被消耗时才被促动,从而防止门意外的释放和突然打开。参照图11a和11b,当门闭合并被锁定时,在按钮轴1107上的衬套1150转动90度,从而远离电力门锁定钩子移动推销。衬套1150借助杆1121被转动,该杆在点1145连接到衬套并与丝杠1116机械接合。衬套1150通过小的销螺线管弹簧加载和锁定。如果当在锁定位置时用户按压按钮,按钮将移动到设备中,但是,由于由衬套的转动所致的位移将不脱离钩子,从而防止门被打开。如果电力消失或者不期望地终止,那么销螺线管将释放,从而允许衬套向后转动90度并布置推销以正确对齐。然后,当用户挤压按钮时,推销将接触电力门钩子并释放门锁闩。该机构提供机械门释放的便利性和安全后备,而不用考虑机械门释放会被意外地促动以使得门大力地摇摆打开。应当认识到,术语“钩子”或者“锁闩”应当广义地限定为能够物理或者机械地接合另一突起或者构件的任何突起或者构件。应当进一步认识到,术语“U形锁闩”并非限定性的,任何锁闩或者钩子机构,如上限定的,都可以使用。
如上讨论的,由底部单元形成并围绕顶部单元的架子空间在终止内外的多个位置采用具有流体传感器的排放路径,以为了使得能够区域性泄漏检测。具体地,通过构建排放路径到终止的外部主体中借助于光学泄漏传感器,系统俘获并导引从外部构件(如吸附剂小罐)到光学泄漏传感器的潜在泄漏的流体。
在一个实施例中,集成在底部单元的外部壳体之内的是至少三个不同的光学泄漏检测器。参照图9a,底部单元902的顶部表面稍微倾斜,中心980相对于侧面981和982升高。在一个实施例中,表面从中心区域980向下倾斜1-10度的角度,优选3度,到侧面981和982。通道987围绕底部单元的顶部表面,围绕周边延伸,延伸通过顶部表面的中心,和/或延伸通过顶部表面的任何的其它部分。通过底部单元902的倾斜的顶部表面,通道987同样从中心980倾斜到侧面981、982。在另一个实施例中,顶部表面同样从后部侧面991向下倾斜到前部表面990。倾斜的通道987使得流体被导引远离中心和/或者向前回到系统并到泄漏检测器988被定位并与通道987流体连通所在的侧面。
第一光学泄漏检测器988a位于底部单元902的顶部表面的右前边角上。第二光学泄漏检测器988b位于底部单元902的顶部表面的左前边角上。每个泄漏检测器定位在井或者腔内并包括光学传感器,该光学传感器位于井的侧面中。光学传感器检测已经排放和/或连通到井的流体并传输检测到的信号到顶部单元中的控制器。检测到的信号通过处理器进行处理,确定是否已经发生泄漏。检出的信号然后被存储,并且如果需要的话处理器发出警报或者警告以显示在GUI上。井或者腔优选地包括圆整的底座以允许用户容易将井擦干。图9b示出底部单元902的顶部表面的更多详细视图,通道987和泄漏检测器988a定位在井997内。
参照图9c,至少一个额外的泄漏检测器位于底部单元902之内,并且更特别地,在储存器903内部,在该储存器903内部集成有标尺904。通道905集成到储存器结构例如内部壳体或者金属袋保持器中,并且优选地从一个侧面倾斜到另一个侧面,或者从中心倾斜到任一侧面。在一个实施例中,该角度是在1-10度的范围内,特别地3度。罩住泄漏检测器的井910集成到储存器壳体中并与在储存器壳体的一个或两个侧面中的通道905连通。如果在一次性袋中发生泄漏,流体将经由通道905排放到金属盘或者储存器壳体的边角并被导向到至少一个具有泄漏传感器910的井中。
排放路径具有两个功能:a)确保流体不进入仪器和b)确保泄漏被快速包含并导引到传感器,该传感器可以触发警报或者警告。此外,装置优选地还包括通向井的流体排放通道,光学传感器布置在装置的内部。因此,例如,如果在内部储存器中存在泄漏,流体远离关键部件导引并且光学传感器警告该泄漏。基于促动的传感器,GUI可以呈现警报给用户并具体识别流体泄漏的位置。通过提供几个独立的泄漏检测带(几个流体传感器和排放路径),仪器可以导引用户以快速发现泄漏。具有多个通道和传感器允许系统部分地、转动地识别泄漏源并提供解决问题的图形帮助给用户。
尽管已经示出和描述目前认为是本发明的优选实施例的内容,但是,本领域技术人员应当理解,可以进行各种变化和修改,并且等效物可以替换其元件,而不脱离本发明的实际范围。此外,可以根据本发明的教导进行许多修改以适应特定情形或者材料,而不脱离本发明的中心范围。因此,意在的是,本发明并不限于作为实施本发明所能想到的最好的模式公开的特定实施例,而是本发明将包括落在所附权利要求的范围内的所有实施例。

Claims (15)

1.一种模块化透析系统,所述模块化透析系统具有控制器单元,所述控制器单元限定内部体积,且包括:
门,所述门被配置来提供到所述控制器单元内的所述内部体积的通路,其中所述控制器单元内的内部体积被配置为容纳歧管;
多个泵靴,所述多个泵靴在所述门闭合时伸入所述内部体积;
锁闩,在所述门闭合时所述锁闩机械地接合;
钩子,所述钩子位于所述控制器单元的所述内部体积的内部;以及
电机,所述电机适于施加运动力以通过90-110磅范围内的力闭合所述门,其中所述电机被配置成在用户希望关闭所述门时施加所述运动力到所述钩子以使所述钩子机械地接合所述锁闩以及在用户希望打开所述门时被反向促动以使所述钩子脱离所述锁闩。
2.如权利要求1所述的模块化透析系统,进一步包括具有第一状态和第二状态的机械释放按钮,其中,在所述第一状态,该按钮能够机械地接合所述钩子,并且其中在所述第二状态所述按钮不能机械地接合所述钩子。
3.如权利要求1所述的模块化透析系统,进一步包括储存器单元,所述储存器单元适于被定位成临近所述控制器单元,其中所述储存器单元具有前侧面,所述前侧面包括配置来提供到所述储存器单元内的内部体积的通路的门。
4.如权利要求1所述的模块化透析系统,进一步包括储存器单元,所述储存器单元适于被定位成临近所述控制器单元,其中所述储存器单元具有顶部侧面,所述顶部侧面具有倾斜表面,该倾斜表面具有多个通道,与至少一个泄漏检测器流体连通。
5.如权利要求1所述的模块化透析系统,其中所述控制器单元适于以在20-600ml/分钟的范围内的血液流速进行操作。
6.如权利要求1所述的模块化透析系统,其中所述控制器单元适于以在50-500ml/分钟的范围内的透析液流速进行操作。
7.如权利要求1所述的模块化透析系统,其中所述控制器单元适于使用在3到8公升范围内的非无菌水来实现透析治疗。
8.如权利要求1所述的模块化透析系统,进一步包括带扣,所述带扣适于可拆卸地贴附透析器。
9.如权利要求1所述的模块化透析系统,进一步包括锁定底座,所述锁定底座适于可拆卸地贴附吸附剂盒。
10.如权利要求1所述的模块化透析系统,进一步包括外部壳体和定位在所述外部壳体内部的金属框架。
11.如权利要求10所述的模块化透析系统,进一步包括直接连接到所述金属框架和所述门内的金属框架的手柄。
12.如权利要求1所述的模块化透析系统,其中所述控制器单元包括图形用户界面,且所述图形用户界面被配置为打开所述门到第一锁定位置并提示用户按压按钮以完全打开所述门。
13.如权利要求1所述的模块化透析系统,进一步包括机械按钮,所述机械按钮被配置为如果被激活则停止透析治疗。
14.如权利要求1所述的模块化透析系统,进一步包括储存器单元,所述储存器单元具有由至少一个弯曲单元支持的标尺。
15.一种模块化透析系统,所述模块化透析系统具有控制器单元,所述控制器单元限定内部体积,且包括:
门,所述门被配置来提供到所述控制器单元内的内部体积的通路,其中所述控制器单元内的内部体积被配置为容纳歧管;
锁闩,在所述门闭合时所述锁闩机械地接合;
钩子,所述钩子位于所述控制器单元的所述内部体积的内部;
电机,所述电机适于施加运动力以通过90-110磅范围内的力闭合所述门,其中所述电机被配置成在用户希望关闭所述门时施加所述运动力到所述钩子以使所述钩子机械地接合所述锁闩以及在用户希望打开所述门时被反向促动以使所述钩子脱离所述锁闩;以及
机械释放按钮,所述机械释放按钮具有第一状态和第二状态,其中,在所述第一状态,所述钩子被机械地接合,并且其中,在所述第二状态,所述钩子不被机械地接合。
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