CN110100283A - 包括具有支持外域的安全集群域的信息技术基础架构的医疗设备系统 - Google Patents

包括具有支持外域的安全集群域的信息技术基础架构的医疗设备系统 Download PDF

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CN110100283A
CN110100283A CN201780079960.3A CN201780079960A CN110100283A CN 110100283 A CN110100283 A CN 110100283A CN 201780079960 A CN201780079960 A CN 201780079960A CN 110100283 A CN110100283 A CN 110100283A
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B·比耶勒
R·佩尔松
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Gambro Lundia AB
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Abstract

在一个实施例中，一种医疗设备信息技术(“IT”)数据传输系统包括集群域、外域和接口域。属于集群域的设备可进行实时通信，使得可用性、安全性、安保、可靠的完整性和性能被保证。外域包括不因直接包括在集群域中而启动的设备，并且可包括用于外部信息系统、呈现设备、个人电脑设备、共享医疗设备和床边医疗设备的设备。接口域使得外域设备能够以双向方式与集群设备进行通信。通信可通过集群中的某些访问节点进行。访问节点使得能够在开放的外域与封闭和私有的集群域之间进行信息的交换。

Description

包括具有支持外域的安全集群域的信息技术基础架构的医疗 设备系统
技术领域
本公开总体上涉及医疗设备系统，并且更具体地说，涉及管理和运行连接到类似诊所信息系统(“CIS”)、计费系统、实验室等的外部系统的信息技术(“IT”)基础架构。
背景技术
用于医疗系统的IT连接性最初仅引进给选定的一组医疗提供者并且是严格专有的。最终，医疗IT系统逐渐开始依赖于标准化的解决方案，它们从成本和发展的角度来看被认为是有利的。不利的方面是，在责任由专有系统提供者承担之前，标准化解决方案将IT系统可靠性的责任分给几个当事人，主要责任由相关的设备制造商、CIS制造商和IT专业人员承担。
管理医疗设备IT系统的基础架构所涉及的复杂性相当大，通常，只有较大的诊所才能负担设定和维持具有保健环境所需的可靠性和可用性的这种系统的费用和能力。其结果是，利用基于IT的支持来提高医疗设备环境(诸如透析诊所)的效率的进展缓慢。事实上，许多人会说，在过去30多年，与当今个人计算与智能移动通信设备的爆炸性发展相比，保健环境几乎没有什么进展。
诊所在将所有子系统和设备合并为一个单位时最终从质量管理和风险分析的角度负责，使诊所的负担进一步加重。该责任使诊所期望使用合格人员进行这种质量和风险管理评估，因为大多数设备和软件制造商在将其产品与其它产品合并时，或在将其产品整合到软件制造商在先或在前不了解的系统中时，将避免承担这种责任。
概括地说，当今多数医疗环境(例如，透析诊所)认识到IT系统在减少错误、文件工作量和其它管理工作量方面的潜力。诊所也认识到管理不同IT解决方案的成本和复杂性，以及对集成这些系统的现成支持(off-the-shelf support)是非常有限的。也就是说，诊所意识到他们将承担实施和维护信息IT方案的责任。然而，多数诊所没有且负担不起专门的IT人员。
虽然存在将IT用于治疗管理的广泛期望，但从数据结构或报告角度来看，现有的许多电子医疗记录系统不能满足需求。因此，在诊所工作流程管理的背景下，现有的系统被认为缺乏对医疗用户需要的理解。
因此，需要针对医疗环境(例如透析诊所，其存在大量的数据管理需要但IT预算相对较少)的改进IT解决方案。
发明内容
本公开的医疗设备信息技术(“IT”)系统和方法学可应用于(例如)诸如用于血浆除去法、血液透析(“HD”)、血液过滤(“HF”)、血液透析过滤(“HDF”)、连续肾脏替代疗法(“CRRT”)处理的医疗设备。本文描述的医疗设备IT系统还可应用于腹膜透析(“PD”)、静脉注射给药和营养液输送。这些模式可在本文中统称或一般地单独称为医用流体输送，然而，IT系统并不局限于医用流体输送，而是通常可以涉及医疗设备。医疗设备可以容纳输送医用流体所需的部件，诸如一个或更多个泵、多个阀门、加热器(如果需要)、在线医用流体生成设备(如果需要)、多个传感器(诸如压力传感器、电导率传感器、温度传感器、空气检测器、血液泄漏检测器等中的任何一个或更多个或全部)、用户接口和控制单元，其可以使用一个或更多个处理器和存储器来控制上述设备。医用流体输送装置还可包括一个或更多个过滤器，诸如用于清洗血液的透析器或血液过滤器和/或用于净化水、透析流体或其它流体的超滤器。
本公开的医疗设备IT系统和方法学可与位于诊所/医院的医疗设备或基于家庭的医疗设备一起使用。一个用于临床环境的适当血液透析机在2014年2月11日发布的美国专利号8,647,290的标题为“Hemodialysis or Hemo(dia)filtration Apparatus and aMethod for Controlling a Hemodialysis or Hemo(dia)filtration Apparatus”中描述，其在2008年5月26日提交。一个用于医院或临床环境的适当CRRT机在2014年12月16日发布的美国专利号8,911,390的标题为“Multipart Fluid System And A System ForRegional Citrate Anticoagulation In An Extracorporeal Blood Circuit”中描述，其在2010年3月31日提交。一个合适的家庭系统在2011年10月4日发布的美国专利号8,029,454的标题为“High Convection Home Hemodialysis/Hemofiltration and SorbentSystem”中描述，其在2004年11月4日转让给本申请的受让人。另一个这样的家庭系统在2013年3月12日发布的美国专利号8,393,690的标题为“Enclosure for a PortableHemodialysis System”中描述，其在2008年8月27日提交。一种可在家庭或诊所使用的合适的腹膜透析系统在2016年2月2日发布的美国专利号9,248,225的标题为“MedicalTreatment System and Methods Using a Plurality of Fluid Lines”中描述，其在2009年1月23日提交。以上每个参考文献的全部内容均通过引用纳入到本文中并依赖于此。
上述类型的医疗设备中的每个可视为多个节点的集群中的一个节点，这些节点共享一个共同的分布式数据库。集群的每个节点将其数据(例如，(i)关于其编程操作参数的数据，(ii)从诸如医疗设备输出数据、事件数据和患者数据等治疗中收集的数据，以及(iii)任何其它相关数据)与集群的其它节点共享。为了共享其数据，集群可被设置为使得节点：(i)将它们的数据相互推送，(ii)从彼此提取它们的数据，或者(iii)彼此之间推送和提取数据。此外，为了共享其数据，集群可被设置为，使得(a)每个节点使用(i)、(ii)或(iii)向彼此发送它们的数据，或(b)可提供一个或更多个核心节点，从节点的子集收集数据，在子集内共享数据连同其自己的数据，使用(i)、(ii)或(iii)将所收集的数据连同其自身的数据传递给任何其它现有的核心节点，以用于分布在另一节点的子集内，并从任何其它核心节点接收收集的数据，以用于分布在其自己的子集内。
无论信息如何在集群或分布式数据库内共享，信息和信息共享都是安全和完整的。由于多种原因，信息是安全的。首先，只有集群兼容的和经过认证的节点才能连接到集群，并且只有这些节点可以共享数据。对该规则的管理例外在下面描述。第二，用于集群的软件在一个实施例中是专有的，使得不具有专有软件的外部设备即使以某种方式连接到与集群的节点相同的网络，也无法与节点进行通信。专有软件可具有标准化的组件，例如，可使用开源软件，但整个软件是专有的。
在一个实施例中，集群由医疗设备制造商提供。安全分布式数据库被部署为参与集群中的节点的每个医疗设备的一部分。集群兼容的医疗设备在网络中连接并自动形成本公开的共享或分布式数据库，其可以在存在于每个物理医疗设备中的物理数据库(例如，基于硬盘的)周围形成。下面讨论的是节点的集群可以控制的许多功能。被设计用于作为集群成员节点运行的设备(节点)的集群承担了处理与开放IT基础架构相关联的复杂性的大部分责任，并且因此对于诊所和任何其它医疗设备环境(其存在大的数据管理需要但IT预算相对较小)来说是有吸引力的选项。一些责任可能仍然存在于诊所，诸如提供布线和其它硬件。
集群及其节点可以被称为形成集群域。预期即使不是全部也是大多数诊所或其它医疗设备环境将具有一些计算机网络，护士、临床医生和技术人员可以使用该计算机网络来运行相关软件，诸如第三方临床软件、计费软件、会计软件等。在集群域外部的任何这种软件可以说形成外域。
一些外域软件可能具有在分布式数据库内共享的至少一些数据的需要。此外，取决于在集群域内处理哪些功能，可存在分布式数据库从外域接收数据并将其传输到外域的需要。为此，可以设想创建或指定分布式数据库的一个或更多个节点作为访问节点。在实施例中，每个访问节点具有内部部分和外部部分，它们可以仅通过一个或更多个受控接口(诸如存储器管理器)彼此通信。访问节点的外部部分与外域交互，而访问节点的内部部分与集群域交互。可以说集群访问节点在开放的外域和内部集群域之间形成接口域。
可以设想提供三种不同类型的访问选项。第一类访问选项是访问节点，其是分布式数据库访问节点。该访问节点维护在所有其它节点之间形成的共享数据库。分布式数据库访问节点可以或者可以不将数据添加到共享数据库，但是在任一种情况下均从生成数据并永久存储数据的所有其它节点接收所有数据。分布式数据库访问节点使客户端设备能够从共享数据库接收数据并将数据添加到共享数据库。虽然访问节点通常被描述为不同于集群的医疗设备，但可以设想医疗设备还可以提供访问能力并因此也形成访问节点。
第二类访问选项也是访问节点，但它是仅转换节点或非分布式数据库访问节点。非分布式数据库访问节点不包含共享数据库，而是被限制为允许客户端设备在功能上与集群节点交互。例如，可能期望通过非分布式数据库访问节点将患者的体重数据有线或者无线地从体重秤发送到集群。在一个实施例中，非分布式数据库节点连接到分布式数据库节点并将其信息传输到该节点。所传输的信息在下一分布式数据库更新处与分布式数据库的其余部分共享。随后，权重数据可连同患者标识符可以被任何节点或需要权重数据的医疗设备(例如，该日治疗患者的节点或医疗设备)来调用。仅转换访问节点使权重数据能够安全地传输到节点的集群，但本身不包含分布式数据库。
除了两种类型的物理访问节点外，还可设想提供在分布式数据库域与外域之间的第三类接口，这种接口可以称为虚拟访问节点。该访问节点由于不涉及额外的硬件，所以被认为是虚拟的。例如，虚拟节点可以是在医生或临床医生的运行在与分布式数据库分离的其自己的开放网络中的计算机中的软件。医生或临床医生的计算机和实验室技术人员的计算机可能运行需要或受益于与分布式数据库共享信息的软件。例如，这种软件可能需要来自实验室技术人员的计算机的数据，例如，患者测试结果。虽然预计医生或临床医生的计算机能够通过访问节点发送服务请求，以调用在分布式数据库中运行的操作例程，但也可能可替代地或也许期望医生的计算机能够实际访问分布式数据库，并确保医生的计算机这样做受到足够的保护。例如，可以通过医生的计算机与存在于医疗设备内部的虚拟访问节点的一部分之间的虚拟专用网络(“VPN”)提供安全性。
本公开的医疗设备IT系统和方法学降低了管理和运行IT基础架构的总体复杂性，同时提供完全的灵活性以连接到部署在医疗设备诊所内部或外部的外部系统(CIS、计费系统、实验室等)。在如可靠性、可用性、安保、安全性和完整性的关键领域的单个负责部分(集群设置及其相关的分布式数据库)方面来隐藏和控制IT系统和方法学，而同时从过程、工作人员和患者的角度提供对诊所中需要的服务的访问。在处理前、处理期间和/或处理后，IT系统和方法学能够将存储在分布式数据库中的与患者有关的医疗信息与诊所的整体医疗记录系统以及患者床边的设备所使用和生成的信息相结合。
本公开的医疗设备IT系统和方法学使数据能够实时地双向流动，例如，在外部医疗设备与集群的医疗设备之间流动，例如，能够在治疗之前基于医生处方和床边生成的信息正确设置透析设备，例如，在处理前、处理期间和/或处理后，在护士和其它透析护理人员的指导下。相反，可能期望将来自医疗设备的实际治疗结果信息，例如在设备上生成和记录的事件(例如，警告、警报)以及护士的与治疗有关的笔记或输入传递回CIS，以进行短期和/或长期的医学评估。
在诊所中运行当前“开放”IT结构的复杂性来源于维护一个应用服务器的基础架构，其具有服务器软件、数据库服务器、备份服务器(与服务器物理地分离)、IT网络(有线或无线的、布线和路由器)以及具有客户端软件的客户端计算机。在具有到外部系统(例如，CIS或任何其它信息管理系统)或从外部系统的访问权限的“封闭”集群设置中，与支持专有连接性设备(访问节点)相结合，将这种基础架构集成在医疗设备内以共同形成分布式数据库，使得这种基础架构的整体可靠性的主要责任被限制并局限在医疗设备及其集成的分布式数据库的控制良好的领域内。
本公开的医疗设备IT系统和方法学的优点也适用于家庭治疗和其它外部情景。例如，可存在单独的节点集群，其形成例如家庭透析机或者透析中心和家庭透析机的混合物的虚拟网络。负责基于家庭的医疗设备的诊所仍然可以从集群所提供的同步机制和其它服务中获益。主要的例外是对传输基础架构的控制，在家庭患者的情况下，其无法声称在集群设置的控制下。这可能影响可用性和性能，因为这种基础架构中的干扰超出了集群的控制范围。然而，除了同步以外，集群设置的多数其它益处将仍然可用，例如安全性、安保、完整性和信息交换将仍然可用，尽管这取决于诊所和患者家庭环境之间的传输链所提供的数据速率。
在通常在诊所接受治疗的患者代替地在诊所外部(例如家、工作旅行或度假)临时接受治疗的情况下，包含诊所或医院外的医疗设备的集群可能是有价值的。本公开的系统可以确保属于诊所的所有医疗设备都以相同的方式设置(例如，在技术上)，无论它们是在诊所内部或是外部使用。在一个实施例中，在患者的家庭位置处使用的医疗设备或节点被限制访问共享数据库，使得患者只能看到他或她自己的数据以及设置和运行治疗所需的信息。外部治疗所生成的数据被添加到共享数据库中。因此，当在医院或诊所外部操作时，该设备未必是从数据库“离线”操作的。
鉴于本文的公开并且不以任何方式限制本公开，在本公开的第一个方面中(除非另有规定，否则其可与本文列出的任何其它方面结合)，医疗设备系统包括：集群，包括多个节点并且运行专有软件；多个医疗设备，实现节点中的至少一些节点；节点中的至少一个是访问节点；分布式数据库，沿着集群共享并由节点中的至少一些节点托管；以及集群外部的至少一个外部设备，该至少一个外部设备运行不同于专有软件的软件，并且能够通过访问节点(i)写入到分布式数据库中的至少一些，或(ii)从分布式数据库中的至少一些中读取中的至少一个。
在本公开的第二方面中(除非另有规定，否则可与本文列出的任何其它方面结合)，至少一个访问节点与医疗设备分离提供。
在本公开的第三方面中(除非另有规定，否则可与本文列出的任何其它方面结合)，至少一个访问节点设置有医疗设备。
在本公开的第四方面中(除非另有规定，否则可与本文列出的任何其它方面结合)，至少一个访问节点不托管分布式数据库。
在本公开的第五方面中(除非另有规定，否则可与本文列出的任何其它方面结合)，至少一个外部设备是第一外部设备，并其还包括通过第二外部设备形成的集群的虚拟访问节点，虚拟访问节点提供安全的数据交换环境，以确保利用第二外部设备操作的集群的安全性。
在本公开的第六方面中(除非另有规定，否则可与本文列出的任何其它方面结合与第五方面结合)，安全数据交换环境包括诸如虚拟专用网络等安全信道。
在本公开的第七方面中(除非另有规定，否则可与本文列出的任何其它方面结合)，至少一个外部设备被设置为将数据传输到分布式数据库，该数据由实施用于治疗的节点之一的医疗设备之一使用。
在本公开的第八方面中(除非另有规定，否则可与本文列出的任何其它方面结合)，多个医疗设备属于相同的治疗类型。
在本公开的第九方面中(除非另有规定，否则可与本文列出的任何其它方面结合)，多个医疗设备正在治疗同一患者。
在本公开的第十方面中(除非另有规定，否则可与本文列出的任何其它方面结合)，分布式数据库由(i)生成将其数据推送到其它节点的每个节点，(ii)具有从其它节点提取数据的分布式数据库的每个节点，或(iii)(i)与(ii)的组合填充。
在本公开的第十一方面中(除非另有规定，否则可与本文列出的任何其它方面结合)，医疗设备系统包括：集群，包括多个节点；一组节点中的每一个节点，由医疗设备实施；分布式数据库，由医疗设备之一托管；至少一个第一访问节点，其托管分布式数据库；至少一个第二访问节点，与分布式数据库分离提供；集群外部的至少一个外部设备，所述至少一个外部设备能够通过至少一个第一访问节点或至少一个第二访问节点(i)写入到分布式数据库中的至少一些，或(ii)从分布式数据库中的至少一些中读取中的至少一个。
在本公开的第十二方面中(除非另有规定，否则可与本文列出的任何其它方面结合)，至少一个第一访问节点和至少一个第二访问节点与医疗设备分离。
在本公开的第十三方面中(除非另有规定，否则可与本文列出的任何其它方面结合与第十一方面结合)，至少一个第一访问节点和至少一个第二访问节点设置有用户接口或利用用户接口操作。
在本公开的第十四方面中(除非另有规定，否则可与本文列出的任何其它方面结合)，医疗设备系统包括：集群，包括多个节点；多个医疗设备，实施节点中的至少一些节点；至少一个节点，其是包括外部部分和内部部分的访问节点；分布式数据库，沿着集群提供并由节点中的至少一些节点托管，分布式数据库，如果由所述至少一个访问节点存储，则与该访问节点的内部部分相关联；集群外部的至少一个外部设备，所述至少一个外部设备能够通过访问节点的外部部分(i)写入到分布式数据库中的至少一些，或(ii)从分布式数据库中的至少一些中读取中的至少一个。
在本公开的第十五方面中(除非另有规定，否则可与本文列出的任何其它方面结合与第十四方面结合)，外部部分和内部部分由处理和存储器管理器分离，该管理器知道如何(i)将来自内部部分的数据设置到外部部分中，(ii)将来自外部部分的数据设置到内部部分中。
在本公开的第十六方面中(除非另有规定，否则可与本文列出的任何其它方面结合)，医疗设备系统包括：集群，包括多个节点；多个医疗设备，实施节点中的至少一些节点，每个医疗设备包括被设置为执行医疗程序的处理和存储器；分布式数据库，由节点中的至少一些节点沿着集群共享，分布式数据库部署在多个医疗设备上，该分布式数据库由处理和存储器管理器与被配置为执行医疗程序的处理和存储器分离，该处理和存储器管理器知道如何(i)将来自分布式数据库的数据放置到被设置为执行医疗程序的处理和存储中，以及(ii)将来自被设置为执行医疗程序的处理和存储器的数据放置到分布式数据库中。
在本公开的第十七方面中(除非另有规定，否则可与本文列出的任何其它方面结合与第十六方面结合)，被设置为执行医疗程序的处理和存储器被设置为通过处理和存储器管理器发起与分布式数据库的通信。
在本公开的第十八方面中(除非另有规定，否则可与本文列出的任何其它方面结合与第十六方面结合)，分布式数据库位于医疗设备的集群控制部分中，该集群控制部分与被设置为执行位于医疗设备的治疗控制部分中的医疗程序的处理和存储器分离，集群控制部分与治疗控制部分由处理和存储器管理器分离。
在本公开的第十九方面中(除非另有规定，否则可与本文列出的任何其它方面结合)，医疗设备系统包括医疗设备系统(110)，其包括：集群(10)，包括多个节点(12)；多个医疗设备，实施至少一些节点(12)；分布式数据库(14)，沿着集群(10)共享并由多个医疗设备托管；外部设备(50)，在集群(10)外部；集群(10)的虚拟访问节点(100)，利用外部设备(50)和医疗设备之一形成，虚拟访问节点(100)提供安全的数据交换环境，以确保在(i)外部设备(50)写入到医疗设备或(ii)外部设备(50)从医疗设备读取时分布式数据库(14)的安全。
在本公开的第二十方面中(除非另有规定，否则可与本文列出的任何其它方面结合与第十九方面结合)，医疗设备包括第一虚拟访问节点接口，外部设备包括第二虚拟访问节点接口，并且其中，安全数据交换环境包括安全信道，诸如与虚拟访问节点接口交互的虚拟专用网络。
在本公开的第二十一方面中，结合图1至图15公开的任意结构和功能可与结合图1至图15公开的任意其它结构和功能进行组合。
鉴于本公开和上述各方面，因此本公开的优点是提供一种改进的医疗信息技术(“IT”)系统，其中将连接性集成到相关的医疗设备中。
本公开的另一优点是降低了对保健环境中IT连接性解决方案的诊所的拥有成本，并且其中，操作的责任集中在具有明确限定的范围的节点集群周围。
本公开的另一优点是提高在保健环境中IT连接性解决方案的可靠性、可用性和正确性。
本公开的另一优点是在保健环境中提供IT连接性解决方案，其对于护理人员(例如，护士)和技术人员来说易于使用，并且减少了间接工作。
本公开的另一个优点是在保健环境中提供IT连接性解决方案，其促进和支持以下人员中的至少一个的需要：护理人员(远程警报、即时访问、双向信息流)，医师，他们的主要关注点是患者的福利和利益(处方更新、对信息的访问(即使属于集群的医疗设备不可用)、患者数据的实时检索)，IT技术人员(降低的IT复杂性、至少部分由医疗设备制造商承担的责任)，服务技术人员(软件安装和更新可以是集群范围的、易获得的历史数据、早期警告诊断)，和/或管理员(容易设定和实施临床偏好、运行报告和获得统计数据、容易安排用于治疗的医疗设备、容易跟踪患者数据)。
此外，本公开的优点是提供IT连接性解决方案，其即时地向所有节点提供所有更新，且信息失真的风险低。
本公开的另一个优点是提供在安全的、实时的分布式医疗设备域和外部的、开放的外域之间的双向的IT连接性解决方案，并且其具有恶意软件免疫力。
本公开的另一优点是为诊所或其它医疗设备环境提供可扩展性，其中医疗设备的集群可单独操作，在安装时可具有一组较少的外部设备，并且如果期望的话，未来还可具有一组扩展的外部数据库。
本发明的另一个优点是提供IT连接性解决方案，其使临时从节点的集群断开(出于选择或意外)的医疗设备节点或访问节点仍然能够访问断开时存在的分布式数据库，并在重新连接到节点的集群时进行更新。
此外，本公开的一个优点是提供一种医疗设备IT连接性解决方案，该解决方案在数据可用性、正确性、安保、安全性、完整性和/或可用性的至少一个方面提供良好的整体可靠性。
本文讨论的优点可以在这里公开的一个或一些，也许不是所有的实施例中找到。本文描述了其它特性和优点，并将从下面的详细描述和图中可以看出。
附图说明
图1是示出共享本公开的分布式数据库的节点的集群的一个实施例的示意图。
图2是包括形成集群域的节点的集群的整体医疗设备信息技术(“IT”)系统的一个实施例的示意图，该集群域通过接口域与开放的外域进行通信。
图3是包括共享分布式数据库的节点的集群的整体医疗设备IT系统的一个实施例的示意图，该分布式数据库通过集群的多个访问节点与多个外部实体交互。
图4是进一步示出外部信息系统设备的示例的示意性视图。
图5是进一步示出呈现类外部设备的示例的示意性视图。
图6是进一步示出平板和计算机类外部设备的示例的示意性视图。
图7是进一步示出共享医疗类外部设备的示例的示意性视图。
图8是进一步示出床边医疗类外部设备的示例的示意性视图。
图9是示出本公开的集群系统的医疗设备节点的放大视图和分布式数据库访问节点的一个实施例的示意性视图。
图10是进一步示出本公开的集群系统的医疗设备节点的隔离方面的示意性视图。
图11和图12是示出本公开的集群系统的分布式数据库访问节点的放大视图的一个实施例的示意性视图。
图13是示出本公开的集群系统的非分布式数据库访问节点的放大视图的一个实施例的示意性视图。
图14是示出集群域如何包括具有分布式数据库的集群以及每个医疗设备节点的治疗控制部分的一个实施例的示意性视图。
图15是示出本公开的集群系统的虚拟访问节点的一个实施例的示意性视图。
具体实施方式
本文描述的示例可应用于任何类型的医疗设备，例如，输送医用流体(诸如血液、透析流体、置换流体或静脉注射药物(“IV”))的医疗设备。示例特别适合于肾衰竭治疗，诸如所有形式的血液透析(“HD”)、血液过滤(“HF”)、血液透析过滤(“HDF”)、连续肾脏替代疗法(“CRRT”)和腹膜透析(“PD”)，它们在本文中统称为或一般地独立地称为肾功能衰竭治疗。可替代地，医疗设备可以是药物输送或营养液输送医疗设备，诸如大容量蠕动型泵或注射器泵。医疗设备可以具有下列中的任何一个或更多个：一个或更多个泵、多个阀门、加热器(如果需要)、在线医用流体生成设备(如果需要)、多个传感器(诸如压力传感器、电导率传感器、温度传感器、空气检测器、血液泄漏检测器等中的任何一个或更多个或全部)、用户接口和控制单元，其可以利用一个或更多个处理器和存储器来控制上述设备。医疗设备还可包括一个或更多个过滤器，诸如用于清洗血液的透析器或血液过滤器和/或用于净化水、透析流体或其它流体的超滤器。
医疗设备在许多情况下包括利用一次性部件操作的可重复使用部件。可重复使用部件可以(例如，在线血液处理透析机)或可以不(例如，腹膜透析机、CRRT机、药物和营养液体输送机)携带处理流体。一次性部件可携带血液(血液处理包括CRRT机)或处理流体(腹膜透析机、CRRT机、药物和营养液体输送机)。
现参照附图并特别参照图1，示出了节点的集群10。集群10包括多个节点12a至12h(在本文中统称为节点12或总体上单独称为节点12)。节点12可以由上面描述的任何医疗设备表示。可替代地，节点12中的任何一个可以是计算机。集群10的多数节点共享一组共同的数据或分布式数据库14。如下面详细讨论的，访问节点12h不拥有或共享分布式数据库14。
分布式数据库14是输入至每个节点12并在每个节点12处生成的所有数据的组合，包括由非分布式数据库节点12h生成的数据。也就是说，即使节点12h不共享分布式数据库14，数据仍然可以通过非分布式数据库节点12h或由节点12h生成，其变为由节点12a到12g共享的分布式数据库14的一部分。
关于节点12a至12g如何共享其数据的许多实施例载于专利合作条约申请PCT/EP2016/064392中，其具有国际提交日期为2016年6月22日和本公开的共同申请人，其全部内容通过引用纳入在本文中并依赖于此。通常，集群10的每个节点12将其数据(例如，(i)关于其编程操作参数的数据，(ii)从诸如医疗设备输出数据、事件数据和患者数据等治疗中收集的数据，以及(iii)其它相关数据)与除特定访问节点(诸如节点12h)之外的集群的其它节点共享。为了共享其数据，集群10可被设置为使得节点12(i)将它们的数据相互推送，(ii)相互间提取它们的数据，或者(iii)彼此之间推送和提取数据。此外，为了共享其数据，集群10可被设置为，使得(a)每个节点12使用(i)、(ii)或(iii)向彼此发送它们的数据，或(b)可提供一个或更多个核心节点，从节点的子集收集数据，在子集内共享数据连同其自己的数据，使用(i)、(ii)或(iii)将所收集的数据连同其自身的数据传递给任何其它现有的核心节点，以用于分布在另一节点的子集内，并从任何其它核心节点接收收集的数据，以用于分布在其子集内。
集群10的节点运行在专有软件上，并且对分布式数据库14的访问被限制为以下所述。软件可以使用现成的组件(诸如开源软件)构建，但整个产品是专有的。因此，即使集群10以某种方式被不正确地访问或黑客攻击，如果没有专有软件(例如，医疗设备制造商自行开发的软件，这些软件可以使用公开可用的软件，例如开源软件，但其本身并不公开可用)，就很难访问分布式数据库数据14。因此，在封闭的环境中，集群10可被信赖处理关于与运行开放IT基础架构的现有诊所相关的复杂性的所有方面。这些复杂性可包括：(i)所需的服务器(服务)和同步化角色；(ii)数据库部署；(iii)所有级别的网络解决方案(可能物理和链路层面除外，其中可以选择在现有/共享硬件基础架构上运行或在现有临床IT硬件解决方案上运行虚拟专用网络)，以及(iv)备份服务器角色，如具有共同数据集14的每个节点12充当备份设备(除了备份服务器必须与任何其它设备在物理上分离的要求之外)。
通过将信息技术(“IT”)基础架构支持集成在医疗设备内，与支持专有连接性设备相结合，在具有受限的对/从集群-外部系统(例如客户信息系统(“CIS”)或任何其它信息系统)的访问权限的“封闭”集群设置中，这种IT基础架构的整体可靠性的责任受到限制并局限在医疗设备的控制良好的领域内，例如，医用流体输送设备节点12。
现参照图2和图3，图1的集群10被示出为整体医疗设备信息技术(“IT”)系统110的一部分。图2示出了系统110包括外域110a、集群域110b和接口域110c，该接口域110c将外域110a链接到集群域110b。在图2中，图1的集群10被示出为集群域110b的一部分。可以存在形成集群域110b的多个集群10。例如，对于上述节点12处的不同类型的医疗设备，可能存在不同的集群10。
集群域110b表示集群数据库服务和基础架构的核心功能。集群域110b处理在它和外域110a之间在集群10入站和出站两个方向上的信息流的传输和转换。如上所述，集群10的每个节点12(除了节点12h以外)保存共享的数据14。集群域110b的每个集群10(在域110b中可以存在多于一个的集群10)的每个节点12是相互同步的，这允许任意成员节点12被关闭同时仍然保持对集群10的服务和信息的外部访问。
集群域110b的每个集群10在网络业务和信息访问两个方面均形成受保护的空间，其结合了大量的冗余，目的是保证集群10始终可用。集群10保持高度的信息完整性；实现从集群外部的客户端访问信息的安全方式，同时满足与节点12的医疗设备到外部设备的连接相关联的建立的安保要求。
在一个实施例中，如果与节点12相关联的医疗设备出于任何原因进行访问而不使用该节点(例如，通过下面讨论的虚拟访问)，则该医疗设备服从某些安保要求。例如，如果医疗设备要通过有线局域网(“LAN”)连接到集群10和一台外部客户端设备，则在一个实施例中，需要两个分离的LAN连接器，一个连接器为集群10连接性而保留，第二连接器用于开放环境连接性。在另一实施例中，可以为集群和开放环境共享LAN连接器，但是采用软件隔离。因此，在集群10内的分离可以采用集群10的LAN连接和到开放环境的连接之间的硬件和软件隔离的不同组合。在严格的与医疗产品相关的严苛条件下开发设备时，提供对这样的隔离和维护质量、IT连接和相关服务的责任，得到冗余的和高度稳定的操作系统。
集群10的一个重要应用是支持设备占用节点12的技术维护。以与节点12复制医疗信息相同的方式，它们还可以复制下载的代码(例如，医疗设备软件更新)。通过例如，经由访问节点12a或12h经由膝上型或平板设备进行连接(如下所述)，服务技术人员可以诊断、设置和更新医疗设备上的软件，包括收集技术统计信息以促进预防性维护。
从医疗角度来看，集群10将在众多领域提供协助，例如，操作处方管理、处理结果汇编和储存、处理疗程报告以及医疗记录管理和支持。从警报角度来看，集群10在集群10的节点12(包括医疗设备和访问节点12)之间不断更新和分布警报以及其它实时事件。
集群10可扮演重要角色的另一个领域是用于不同类型的连接设备之间的同步。在一个示例中，多台在线透析流体生成透析机可流体地连接到中心供水回路，该中心供水回路向机器供应净化水，该机器使用净化水来制备透析流体。供水回路需要定期清洁，例如，通过热水消毒。在一个实施例中，集群10的定制软件能够确定透析机节点12中的每一个何时可用于对其供水回路的部分进行消毒，使得消毒序列可开始有效地和优化地清洁整个供水回路，包括将机器连接到供水回路的其余部分的回路的部分。集群10可报告所有相关医疗设备节点12(非医疗设备访问节点排除在外)可用于清洁期，在该清洁期时，中心水厂发起热水回路消毒。注意，对中心供水回路消毒的请求可能来自于(i)集群10内，例如，专有软件被设置为提示在所有医疗设备节点12停止并且自上次消毒以来至少已经过了特定量的时间或总服务时长时；或来自于(ii)中心水厂，例如，自上次消毒以来至少已经过特定量的时间或总服务时长。医疗设备节点12可与外部设备同步的其它示例包括软件更新，其中更新可安排在下一次每个医疗设备节点12停止时进行，此时集群10报告其已为新软件做好了准备。
还可设想集群10的节点12之间的协作不限于医疗应用。例如，集群10可以存储和同步信息，以支持患者在透析中心的娱乐偏好，如喜爱的网站、电视和广播频道、电影、食品和饮料。无论使用集群10的哪种医疗设备来治疗患者，这些信息都是可用的。
集群域110b的集群10为下面列出的众多应用领域提供了具有高度完整性的强大平台。下面的列表并不是详尽无遗的，而是用于举例说明从封闭集群域110b中受益的多种服务。以下列表的每一项都以一种方式从集群域110b提供的安全性、安保和质量方面获得了另一种益处，包括：(i)诊所行政服务，(ii)工作人员和患者行政服务，(iii)注意服务，包括信息呈现服务、工作人员援助呼叫服务、医疗设备警报分布服务和工作人员提醒服务，(iv)连接性服务，包括集群节点连接性服务、连接性等级服务和透析监测连接性服务；(v)设备服务，包括透析监测服务和水净化系统服务；(vi)金融服务，包括透析计费服务；(vii)识别服务，包括透析疗程识别服务、药物识别服务、透析站识别服务、一次性识别服务，设备识别服务、患者识别服务和工作人员识别服务；(viii)信息管理服务，包括诊所信息服务和患者信息服务；(ix)库存服务，包括库存消费跟踪服务、产品追溯服务和再利用追溯服务；(x)安排服务，包括设备安排服务、患者安排服务和工作人员安排服务，(xi)安保服务，包括访问控制服务、可用性保护服务、机密性保护服务、加密服务和完整性保护服务；(xii)治疗服务，包括评估服务、咨询服务、透析疗程服务、透析疗程记录服务、医疗测试服务、处方服务和血管通路服务；以及(xiii)水净化服务，包括分配回路服务和水质服务。
在图2中，外域110a在一个实施例中是使用标准的现成硬件和软件的开放IT环境域。该现成结构唯一的例外是部署在外域110a设备上的软件应用，出于通过接口域110c与集群域110b进行交互的目的。在许多情况下，外域110a设备不容易设计，因此将不接收用于与集群10交互的定制软件。相反，访问节点12a和12h包含用于读取从外部设备输入的数据的交互软件。然而，在医生或临床医生的计算机的情况下，可存在安装在计算机上的应用软件，该计算机具有存储在节点12处的对应应用软件或用于与存储在节点12处的应用软件进行交互的软件。外域110a设备可包括非专有设备，其不被设计用于包括集群域110b，因此需要额外的设备(接口域110c)来与集群域110b交换信息。
图3更加详细地示出了外域110a以及与具有形成接口域110c的至少一部分的访问节点12a和12h的集群域110b操作。在示出的实施例中，外域110a由以下分类或类型的设备来表示：(i)外部信息系统50a，其可以是受益于与集群10的成员节点12交换信息的集群10外部的任何信息系统；(ii)呈现设备50b，其可以是主要用于呈现从集群10检索到的信息的任何设备，例如，所有尺寸和技术的显示屏幕(可选地是触摸型)，(iii)平板和个人计算机设备50c，其可以是用于在外域110a和集群域110c设备(例如，智能电话、智能平板、膝上型计算机、固定个人计算机(“PC”)、混合设备和类似的基于计算机的设备)之间交换信息的任何基于键盘的或基于触摸的用户接口设备，(iv)共享(例如，医疗)设备50d，其可以是用于支持在患者之间共享的医疗设备临床过程(作为患者在诊所期间登记前和/后活动的一部分)的任何设备(医疗或非医疗)，(例如，患者预处理和/或后处理体重秤和登记站、血压站、诊所到达/离开登记和出于类似目的在临床中部署的设备)(这种共享设备通常配备有、连接到和/或与某种个人识别设备一起使用)，以及(v)床边(例如，医疗)设备50e，其可以是部署在患者床边并且在治疗的部分或全部持续时间期间与(服务)特定患者相关联的任何设备(医疗或非医疗)，例如，用于透析流体制备的水反渗透单元、血压计、娱乐控制台和出于类似目的在床边部署的其它设备。
虽然图1和图3示出了具有分布式数据库访问节点12a和非分布式数据库访问节点12h的集群10，但应该认识到，包含一个或更多个节点12b-12g的任何集群可能具有(i)仅一个或更多个分布式数据库访问节点12a，(ii)仅一个或更多个非分布式数据库访问节点12h，(iii)一个或更多个分布式数据库访问节点12a和一个或更多个非分布式数据库访问节点12h，(iv)仅虚拟访问节点100(下文所述)，以及(v)虚拟访问节点100与任意一个或两个分布式数据库访问节点12a和非分布式数据库访问节点12h的任意一个或更多个的组合。
图4说明了外部信息系统50a的非限制性示例。外部信息系统50a可以采取许多不同的形式，从纯粹的行政系统(例如，帐单和报销)到专门的和专业的与医疗有关的系统(诸如实验室分析系统和诊所信息系统)。图4列出的示例包括但不限于本地诊所信息系统、基于云的诊所信息系统、电子医疗记录系统、健康信息系统、医疗质量监测系统、实验室分析系统、全国注册系统、帐单和报销系统以及库存系统。
实施例中的外部信息系统50a通过到接口域110c的一个或更多个分布式数据库访问节点12a的有线或无线连接而连接到集群10。
图5示出了呈现设备50b的非限制性示例。呈现设备50b包括手持或固定的设备(例如，安装在墙上)，其主要(但不是唯一的)目的是向治疗诊所内的工作人员和/或患者呈现信息。呈现设备50b通常不生成输入到集群10的医疗设备中的数据，但是，如果它们具有触摸支持能力，则它们可以可选地用于输入。例如，呈现设备50b可以呈现患者信息，以用于在治疗期间引导到达的患者通过各种步骤。例如，到达诊所的患者可具有访问安排信息的权限，包括前后体重登记位置/状态和用于接受治疗的治疗站位置。工作人员信息屏幕可以呈现患者的准备状况、透析站的占用和治疗进展以及临床中各治疗地点的警报信息。
实施例中的呈现设备50b通过到接口域110c的一个或更多个分布式数据库访问节点12a的有线或无线连接而连接到集群10。
图6示出了平板电脑和个人电脑(“PC”)设备50c的非限制性示例。平板电脑和PC设备50c可能需要更多的输入密集和先进的信息交换，而目前实际使用的是手持设备，例如，智能电话或平板电脑。然而，平板电脑和混合的平板/PC技术的进步使这两种类型的设备处于50c设备之下。部署在设备50c上的软件可以从非常简单的应用程序到高度先进的应用程序(包括面向访问存储在集群10中的信息的完整的CIS接口和环境)。这些应用可为诊所工作人员(医生、护士、技术服务人员和行政人员等)呈现用户接口，以访问和更新服务领域中的信息或特征，诸如行政服务、工作人员和患者护理服务、连接性服务、设备技术服务和维护服务、账单和报销服务、识别服务、信息管理服务、库存服务、安排服务、安保服务、患者医疗服务、治疗服务和水净化服务。
实施例中的平板电脑和PC设备50c通过(i)有线或无线连接到接口域110c的一个或更多个分布式数据库访问节点12a或(ii)在没有访问节点硬件的情况下的虚拟访问连接，连接到集群10。移动连接使医生能够对原始操作参数处方进行床边改变，这些改变随后立即分配到共享数据14中，并在节点12的合适医疗设备上生效。在移动性不是最高优先级的情况下，可交替使用膝上型计算机或固定PC，例如用于长期与集群10交互。
图7示出了共享的例如医疗设备50d的非限制性示例。共享的例如医疗设备50d包括在临床中同时存在的患者之间共享的设备。共享设备50d可以具有医疗或非医疗目的。尽管用于共享医疗或医疗相关目的的设备是普遍的，但是多种其它设备，诸如为行政目的和/或支持临床治疗过程的设备也属于该类别。
一个示例是患者体重预处理和后处理登记。在诊所或其它治疗环境中，可以由多个患者共享体重秤。在称重时识别每个患者，例如，通过将患者的姓名或患者识别符(“ID”)输入到称重设备或通过(例如)呈现给存在于称重站处的设备的患者ID卡。随后，登记的和识别的重量被传输到集群10的分布式数据库14，并且例如存储在该患者的重量文件中。无论患者被分配给哪个节点，医疗设备都检索患者该日的预处理重量，并且例如将重量输入到机器中以与患者的处方共同使用。预处理重量可以与已知干重结合使用，以确定从接受透析处理的患者中去除多少过量的血水或超滤。共享设备的其它示例包括血压测量设备、葡萄糖测量设备和当患者进入和离开诊所时用于登记的患者登入和登出设备。
在各种实施例中，共享设备50d通过到接口域110c的一个或更多个分布式数据库访问节点12a或非分布式数据库节点12h的有线或无线连接而连接到集群10。如果共享设备50d不需要来自分布式数据库14的任何数据，则可以使用非分布式数据库访问节点12h。
图8示出了床边的例如医疗设备50e的非限制性示例。床边设备可以像共享设备50d一样具有医疗或非医疗原因或目的。例如，非医疗床边或患者专用设备50e可包括个人通信、娱乐(例如，HDMI连接的电视)、患者工作相关设备和患者识别设备。非医疗床边或患者专用设备50e可能不需要访问来自分布式数据库14的数据，并且如果是这样的话，则可以通过到接口域110c的一个或更多个非分布式数据库节点12h的有线或无线连接而连接到集群10。然而，共享数据14可以受益于与非医疗床边设备50e的交互。在一个示例中，集群10的分布式数据库14可以为每个患者形成存储关于最喜欢的网站、电视频道、无线电台等的个人偏好的个人偏好文件。
床边或患者专用设备50e当然可以是医学相关的。某些诊所可以为节点12的每个医疗设备提供血压袖带，使得在处理期间可以跟踪血压。另一示例是用于使透析流体进行透析的水净化设备。在任何一种情况下，医疗床边或患者专用设备50e可以或可以不需要访问共享数据14，并且因此通过(i)有线或者无线连接到一个或更多个分布式数据库访问节点12a或接口域110c的一个或更多个非分布式数据库节点12h或(ii)如本文所述的虚拟访问节点，连接到集群10。
另一个示例涉及在血液透析或其它血液清洗处理期间向患者输送药物，例如用于红细胞的EpgenTM或用于铁/蔗糖的VenoferTM。这些药物可以通过节点12的透析机泵或通过外部泵输送。如果由透析机泵提供，则药物输送已经是集群10的一部分。然而，如果通过单独的泵提供，例如，该单独的泵是根据需要在诊所中使用的浮动泵，则单独的泵可通过接口域110c的分布式数据库访问节点12a或非分布式数据库节点12h访问分布式数据库14，以用于药物输送泵和节点12的透析机之间的双向通信。节点12的透析机将任何期望的药物输送数据添加到集群10的分布式数据库14，而外部药物输送泵可记录任何期望的数据，诸如在以血压读数、生物阻抗读数、水合水平读数或来自患者的主观响应的形式输送到透析机的用户接口中之后的患者响应。在一个实施例中，药物输送泵是其自身的浮动泵的集群10的一部分，并将数据馈送到其自身的分布式数据库14。
另一示例涉及患者正在其中接收多种药物的医院病房或药物输送环境。这里，可预期实施一个或更多个集群10。第一集群10可以在患者周围形成，其中节点12由不同的泵或一个或更多个泵的不同通道连同在药物输送期间分析患者的任何设备形成。所得到的分布式数据库14可用于电子医疗记录(“EMR”)、计费和其它目的，并且可写入专有软件以实现共享数据14的任何目标。例如，可能希望(i)记录对输送药物的任何反应，例如，血压读数、生物阻抗读数、水合水平读数或由护士输入的患者的主观响应，或(ii)记录对输送药物的组合的任何反应，例如血压读数、生物阻抗读数、水合水平读数或由护士输入的患者的主观响应。也可针对每种药物记录药物输送时间、剂量、剂量率等。
可以在特定药物周围形成第二集群10，例如，药物制造商可以发现关于其药物的集合数据是非常有价值的。在此，节点12位于多个床边，每个床边输送要分析的药物。可将专有软件写入条带(strip)，或简单地不记录任何患者识别数据，而是将多个患者对输送药物的任何反应(例如，血压读数、生物阻抗读数、水合水平读数或由护士输入的患者的主观响应)记录到分布式数据库14中。专有软件可被写入以在分布式数据库14处记录患者类型数据，例如，性别、年龄、人种、种族。软件还可以记录从其它药物的输送收集的数据，例如，在患者接收制造商的药物与分布式数据库14中的一种或多种其它药物时的任何上述反应。在此，这样的其它药物信息可通过一个或更多个访问节点12a或12h进入。
如上所述，刚刚描述的两种药物输送集群10可以同时和同步地运行。
现在参照图2、3和9，更详细地描述了接口域110c。集群接口域110c充当(外观)以访问集群设置的服务，而不暴露实际集群实施、基础架构和设定的内部。如上所述，访问节点12a和12h形成接口域110c的一部分。同样如上所述，如果访问的主要目的仅为信息访问，则大多数设备50a到50e(在此被统称为设备50或通常单独称为设备50)可以通过分布式数据库访问节点12a、非分布式数据库节点12h或虚拟访问节点连接到分布式数据库。
在一个实施例中，分布式数据库访问节点12a是集群10的完全合格的成员，并且在内容以及服务能力方面将复制的数据集14保持为与由图1、2和9中的医疗设备节点12b到12g主持的分布式数据库14相同。因此，即使集群10的所有其它医疗设备节点12b到12g被关闭，通过访问节点12a和12h的集群10仍然可以用于外部访问。在一个实施例中，非分布式数据库节点12h在外域110a的设备50(例如，不满足集群10基础架构要求的任意设备)与集群域110b的内部(受保护的)基础架构之间提供接口转换。例如，非分布式数据库节点12h允许来自任意共享设备50d和床边设备50e的数据连同来自患者识别设备的患者识别数据发送到分布式数据库14，以用于患者医疗记录存储。
在连接性能力方面，分布式数据库访问节点12a和非分布式数据库节点12h在一个实施例中是相同的。每个可连接到上述类型的设备50a至50e中的任何一个。
图2示出接口域110c包括进入域110b的分布式数据库14中的第三类访问，即，虚拟访问节点100。虚拟访问节点100是虚拟的，这是由于不存在代表节点的额外设备，如同访问节点12a和12h的情况一样。在一个实施例中，虚拟访问节点100要求在连接的客户端设备50和集群10的医疗设备节点12之间共享用于保持外域110a和集群域110b之间的隔离的责任。在一个实施例中，客户端设备50连接到集群域110b，以保证传输到集群10的信息的完整性。可以通过直接连接到集群10环境的虚拟专用网络(“VPN”)连接提供安全的连接性。例如，虚拟访问节点100可允许在诊所或医疗设备环境内连接的医生、临床医生或技术人员计算机通过VPN访问分布式数据库14。这些计算机可以运行用于为节点12的医疗设备开发操作例程的设备处方软件。计算机可通过虚拟访问节点100操作，以发送和接收(例如)要输入到处方软件中的实验室结果。一旦处方操作例程完成，则可以经由虚拟访问节点100将其放置到分布式数据库14上，其在针对一个患者或多个患者已开发操作例程的文件夹下。客户端计算机还可以使用保护的虚拟访问节点100以从集群10的分布式数据库14中提取数据，例如，以从一个或更多个操作例程中查看处理结果，以查看是否需要修改或替换它。
现参考图9和图10，更详细地示出集群兼容的医疗设备节点12b到12g…12n。图9示出了在集群10内操作的医疗设备节点12b到12g…12n，并突出显示医疗设备节点12f，而图10在医疗设备节点12f的分布式数据库14侧提供了更详细的细节。图9和图10两者均示出医疗设备节点12f包括两个分离的(由硬件和/或软件分离)部分，即，治疗控制部分28a和集群控制部分28b。在示出的实施例中，治疗控制部分28a包括在中间件16上托管(host)的服务器接口。服务器接口和中间件16与医疗设备操作软件20共同操作，该医疗设备操作软件20可以包括主医疗设备控制处理器和存储器中的任何一个或更多个、一个或更多个安全处理器和存储器、用户接口处理器和存储器以及一个或更多个低级控制器(诸如传感器板、泵控制板等)，用于传感器和致动器22(图10)。上述功能中的任一个和全部功能可以可替代地组合在单个处理器和存储器上。
在示出的实施例中，服务器接口和中间件16驱动医疗设备节点12的用户接口18。用户接口18可以例如显示设置屏幕、治疗屏幕、技术数据等。如果患者希望从患者期望的网站(例如，通过由医院或诊所提供的因特网连接)查看网页，则在图9中作为集群14的一部分提供的诸如分布式数据库访问节点12a的访问节点的用户接口18处，患者可以这样做。这些网站可以被存储在分布式数据库14中针对患者的偏好文件中，使得无论患者接下来使用群10的哪个访问节点，优选的网站都是已知的。访问节点12a、12h可以放置在每个医疗设备节点12b到12g…12n处，以提供由患者和/或护理员使用的因特网访问。
集群控制部分28b容纳复制的数据库14，在图中9该数据库14由在集群10的节点12a至12g和12n-2至12n处的医疗设备共享。集群控制部分28b被仔细构造以满足针对受保护的内部集群基础架构的安保、安全性、可用性、完整性和其它方面的要求。此外，由于治疗控制部分28a运行处理，所以它负责患者的安全，因此不应面对与分布式数据库14竞争资源(时钟周期、存储器消耗等)。在一个实施例中，处理和存储器管理器120因此可以被应用在医疗设备节点12f的治疗控制部分28a与集群控制部分28b之间。例如，处理和存储器管理器120可由能够处理硬件支持的处理和存储器保护和虚拟化的LinuxTM操作系统或其它操作系统来支持。在一个实施例中，处理和存储器管理器120将(i)源自治疗控制部分28a的数据复制到集群控制部分28b中，以及(ii)以保留部分28a和28b之间的隔离的方式(例如，部分28a和28b从不共享或看到彼此的存储器区域)将源自集群控制部分28b的数据复制到治疗控制部分28a中。
在一个实施例中，治疗控制部分28a的服务器接口和中间件16知道何时与分布式数据库14自由共享数据，因此被赋予利用内部部分112b发起数据传输的责任。治疗控制部分28a的服务器接口和中间件16当有数据要发送时，通过存储器处理和存储器管理器120将数据发送到集群控制部分28b，，并且在它准备好时，将自己打开以从分布式数据库14接收数据。
图10更详细地说明了集群控制部分28b。除了分布式数据库14以外，集群控制部分28b还包括集群数据库管理器24和集群通信接口26。集群数据库管理器24和集群通信接口26可以是单独的软件，其中集群数据库管理器24负责通过处理和存储器管理器120从中间件软件16接收数据，并安全地将数据转换成适于分布式数据库14的存储格式。集群数据库管理器24还负责安全地将从分布式数据库14检索的数据转换为适合治疗控制部分28a的中间件软件16和医疗设备操作软件20的格式。
在一个实施例中，集群通信接口26是用于控制如何向集群10的其它节点12发送和从集群10的其它节点12接收数据的消息收发监控器。上面讨论的是数据可以在集群10的不同节点12之间分布的许多不同的方式。集群通信接口26知道所选择的数据传输设置，并使其节点12f在适当的时间和/或以适当的顺序与其它节点12安全和完整地发送和/或接收数据。
现参照图11和图12，更详细地示出了分布式数据库访问节点12a。如本文已经讨论的，分布式数据库节点12a包括并是分布式数据库14的一部分，并且与外部设备50交互。分布式数据库节点12a包括其自己的服务器接口和与集群访问节点逻辑118(访问节点的操作软件)共同操作托管的中间件116。与医疗设备节点12b至12g和12n-2至12n类似，分布式数据库访问节点12a包括由如上所述的处理和存储器管理器120分离的外部部分112a和内部部分112b，从而在分布式数据库14和服务器接口与中间件116之间建立了清楚和清晰的分离。分布式数据库访问节点12a能够从分布式数据库14检索并向外部设备50发送信息。分布式数据库访问节点12a可以从外部设备50(诸如CIS)和服务器客户端(诸如计算机、显示设备、手持智能设备(诸如智能电话或智能平板)和/或医疗设备(诸如体重秤))接收数据并存储在共享分布式数据库14中。
例如，外部部分112a与外部设备50之间的连接性可通过有线局域网(“LAN”)、无线局域网(“WLAN”)或蓝牙技术等。如果通过外部设备50与分布式数据库访问节点12a之间的物理LAN线缆进行连接，则线缆可以是来自任何其它外部设备线缆的单独线缆，并且连接到访问节点12a的专用端口。
图11和图12示出分布式数据库访问节点12a可包括其自己的用户接口18，其与服务器接口和中间件116共同操作。如上所述，分布式数据库访问节点12a的用户接口18可以将因特网站点显示给正在接受治疗的患者或例如需要帮助的护理员。用户接口18还可将设置屏幕、治疗屏幕、技术数据等显示给患者或护理员。再次，患者或护理人员对任何外部内容的选择可存储在共享数据库14中的偏好文件中。
外部设备50与分布式数据库14之间的数据传输可以在没有直接通过集群访问节点逻辑118的应用干扰的情况下发生。访问节点接口和中间件116和访问节点逻辑118可以主持访问节点设置软件和应用，例如，网络客户端(internet explorer、google chrome等)，用于通过集成或外部连接到访问节点12a的用户接口18进行用户交互。集群访问节点逻辑118可以对数据进行错误检查，并且如果需要的话，可以将数据组合为可与分布式数据库14使用的形式。例如，可以存在向分布式数据库访问节点12a提供治疗操作处方的第一外部设备50和提供患者重量数据的第二外部设备50。集群访问节点逻辑118可以协助分类和汇编相关数据，例如，与同一患者ID相关联的数据，并将其路由到分布式数据库14中的特定条目。
图11和图12还示出分布式数据库访问节点12a可以如何分别存储不同的外部设备/系统接口软件，例如，用于不同外部设备(例如，50a和50e)的软件150a和150e(在此统称为外部设备/系统接口软件150，或者通常单独地称为外部设备/系统接口软件150)。提供外部设备/系统接口软件150，用于特定外部设备50，以将信息发送到分布式数据库14和从分布式数据库14接收信息。外部设备/系统接口软件150与集群访问节点逻辑118之间的相互作用提供第一层隔离(如图12中的外部部分112a中的上虚线所指示的)。该第一隔离的目的是防止错误或恶意的外部设备影响访问节点逻辑118。
由处理和存储器管理器120从外部部分112a分离的分布式数据库访问节点12a的内部部分112b，以与上述针对医疗设备节点12f描述的集群控制部分28b相同的方式操作。具体地，数据库管理器24可以负责通过处理和存储器管理器120从集群访问节点逻辑118接收数据，并将该数据安全地转换为适于分布式数据库14的形式。集群通信接口26同样是消息收发监控器，用于知道如何将数据发送到集群10的不同节点12和从集群10的不同节点12接收数据。处理和存储器管理器120向分布式数据库访问节点12a提供第二层隔离。
现参照图13，更详细地说明非分布式数据库访问节点12h。非分布式数据库节点12h不具有用于分布式数据库14的其自身的存储器存储，但是与这里所讨论的外部设备50交互。非分布式数据库节点12h可以分别向分布式数据库14发送和从分布式数据库14接收数据，并且来自分布式数据库14的数据可以显示在其用户接口18上。但是分布式数据库14不存在于非分布式数据库节点12h处，因此在不访问其它节点的情况下不能被访问。另一方面，利用分布式数据库访问节点12a，即使访问节点12a是集群10的唯一可用节点12，数据库14也是可访问的。
在一个实施例中，非分布式数据库访问节点12h的数据库管理器24和集群通信接口26、处理和存储器管理器120、集群访问节点逻辑118、服务器接口和中间件116、外部设备/系统接口软件150如上面针对分布式数据库访问节点12a所描述或引用的那样操作。
在上述实施例中，治疗控制部分28a/外部部分112a可以在其自己的一个或更多个处理器和存储器上提供，该处理器和存储器与用于集群控制部分28b/内部部分112b的一个或更多个处理器和存储器分离。在可替代实施例中，治疗控制部分28a/外部部分112a可以设置在与集群控制部分28b/内部部分112b相同的处理器和存储器上，但被保持在存储器的不同部分上，并且仍然可以由处理和存储器管理器120分离。
此外，虽然已将访问节点12a和12h描述为物理上与集群10的医疗设备节点12b到12g和12n-2到12n分离，但是访问节点12a和12h的额外结构和功能可以可替代地提供为容纳在与医疗设备节点12b到12g和12n-2到12n中的一个共同的壳体中的单独节点。具体地，如上所述，服务器接口和中间件116、集群访问节点逻辑118和外部设备/系统接口150可以被添加为外部部分112a，其在医疗设备节点12b到12g和12n-2到12n的治疗控制部分28a旁边操作。在一个实施例中，控制部分28a和外部部分112a都通过处理和存储器管理器120以本文描述的方式与集群数据库14、集群数据库管理器24和集群通信接口26分离。在一个实施例中，医疗设备内的访问节点12a是与医疗设备节点12b到12g和12n-2到12n分离的节点。即使两个节点共享相同的壳体(并且可以共享集群数据库管理器24和集群通信接口26)，访问节点12a也可以独立于医疗设备节点进行操作。由访问节点12a接收的信息不必用于其主机医疗设备，并且可以是集群10的另一医疗设备所需的信息。该信息存储在分布式数据库14上。同样，位于医疗设备内的访问节点12a可以从分布式数据库14中提取数据，并将其发送到外部设备50，无论该信息已经由主机医疗设备还是由集群10的另一医疗设备生成。
现参照图14，将医疗设备节点12b至12e的治疗控制部分28a和集群控制部分28b以及图9至图13的分布式数据库访问节点12a的外部部分112a和内部部分112b与图2的外域110a、集群域110b和接口域110c一起示出。图14通过圆圈表示集群10，并示出集群域110b包括集群10。此外，集群域110b包括医疗设备节点12b至12e的治疗控制部分28a。图14重申外域110a包括外部设备50。
图14还示出集群10包括医疗设备节点12b至12e的集群控制部分28b和分布式数据库访问节点12a的内部部分112b(包括分布式数据库14)(也会包括非分布式数据库访问节点12h的内部部分112b)。在示出的实施例中，分布式数据库访问节点12a的外部部分不是集群域110b的一部分，而是连同集群10的任何其它访问节点的外部部分112a形成接口域110c。图2和图3示出了在接口域110c内具有分布式数据库14的分布式数据库访问节点12a。分布式数据库14如图2和图3中的方式将分布式数据库访问节点12a与非分布式数据库访问节点12h区分开来。然而，从图14应该理解，完全访问节点12a的分布式数据库14属于集群域110b的集群10内。
现参照图15，示出了虚拟访问节点100的一个实施例。在示出的实施例中，虚拟访问节点100包括医疗设备节点(诸如医疗设备节点12f)与外部(开放侧)设备50(诸如外部计算机(医生、护士或技术人员的计算机))之间的接口。医疗设备节点12f设置有上述关于图10描述的中间件16、用户接口18、服务器接口20、致动器22、分布式数据库14、集群数据库管理器24和集群通信接口的每个结构和相关的功能。
在示出的实施例中的计算机50具有已安装其上的第三方应用软件114，诸如用于开发治疗操作处方的软件。例如，第三方应用软件114可以从分布式数据库14接收数据，并使用它来分析或形成新的治疗操作处方。如果期望的第三方应用软件114不存在，或者医院或诊所不拥有这种软件，则可设想向虚拟访问节点100提供专有数据处理软件102，该软件使用从分布式数据库14检索的数据来执行与第三方应用软件114相同的和/或额外功能。在任何一种情况下，专有数据处理软件102和第三方应用软件114可以反过来创建存储在分布式数据库14处的数据。
第三方系统接口104将来自第三方应用软件114的数据转换为安全通信信道所需的形式，例如，存在于医疗设备虚拟访问节点接口108a与外部设备虚拟访问节点接口108b之间的虚拟专用网络(“VPN”)106。VPN 106本质上是医疗设备节点12f与外部设备50之间的加密桥。VPN 106可由集群10的安装器提供和安装。在示出的实施例中，专有数据处理软件102，在由第三方系统接口104转换之后，被构造成在医疗设备虚拟访问节点接口108a和外部设备虚拟访问节点接口108b之间通过VPN 106直接通信。
一旦在医疗设备节点12f内部，来自外部设备虚拟访问节点接口108b的数据就通过处理和存储器管理器120安全地从治疗控制部分28a发送到集群控制部分28b，通过集群数据库管理器24提供给分布式数据库14，并以上述方式通过集群通信接口26发送到其它节点。来自分布式数据库14的数据可通过集群数据库管理器24转换，并通过处理和存储器管理器120安全地从集群控制部分28b发送到治疗控制部分28a，通过VPN 106从接口108a发送到接口108b，并通过第三方系统接口104处的转换从那里发送到一个或两个专有数据处理软件102和/或第三方应用软件114。
应该理解的是，对本文描述的当前优选实施例的各种改变和修改对于本领域技术人员来说将是显而易见的。可以在不脱离本主题的精神和范围的情况下进行这种改变和修改，并且不会削弱其预期的优点。因此，所附权利要求书意在涵盖这样的改变和修改。

Claims (20)

1.一种医疗设备系统(110)，包括：
集群(10)，包括多个节点(12)并运行专有软件；
多个医疗设备，实施节点(12)中的至少一些；
至少一个节点(12)是访问节点(12a，12h)；
分布式数据库(14)，沿着集群(10)共享并由多个节点(12)中的至少一些托管；
至少一个外部设备(50)，位于集群(10)外部，至少一个外部设备(50)运行与所述专有软件不同的软件并且能够通过访问节点(12a，12h)执行下述中的中的至少一个：(i)写入到分布式数据库(14)中的至少一些或(ii)从分布式数据库(14)中的至少一些读取。
2.根据权利要求1所述的医疗设备系统(110)，其中，至少一个访问节点(12a，12h)与医疗设备分离地提供。
3.根据权利要求1或2所述的医疗设备系统(110)，其中，至少一个访问节点(12a)设置有所述医疗设备之一。
4.根据前述权利要求中的任意一项所述的医疗设备系统(110)，其中，至少一个访问节点(12h)不托管分布式数据库(14)。
5.根据前述权利要求中的任意一项所述的医疗设备系统(110)，其中，至少一个外部设备(50)是第一外部设备，并且其还包括通过第二外部设备(50)形成的集群(10)的虚拟访问节点(100)，虚拟访问节点(100)提供安全的数据交换环境，以确保与第二外部设备(50)操作的集群(10)的安全。
6.根据权利要求5所述的医疗设备系统(110)，其中，安全的数据交换环境包括诸如虚拟专用网络(106)的安全信道。
7.根据前述权利要求中的任意一项所述的医疗设备系统(110)，其中，至少一个外部设备(50)被设置为将数据传输到分布式数据库(14)，所述数据由实施用于治疗的多个节点(12)之一的多个医疗设备之一使用。
8.根据前述权利要求中的任意一项所述的医疗设备系统(110)，其中，所述多个医疗设备属于同一种治疗类型。
9.根据前述权利要求中的任意一项所述的医疗设备系统(110)，其中，所述多个医疗设备治疗同一个患者。
10.根据前述权利要求中的任意一项所述的医疗设备系统(110)，其中，由(i)生成将其数据推送到其它节点(12)的每个节点(12)，(ii)具有从其它节点(12)提取数据的分布式数据库(14)的每个节点(12)，或(iii)(i)与(ii)的组合来填充分布式数据库(14)。
11.一种医疗设备系统(110)，包括：
集群(10)，包括多个节点(12)；
一组节点(12)，其中的每个由医疗设备实施；
分布式数据库(14)，由医疗设备中的每个来托管；
至少一个第一访问节点(12a)，托管分布式数据库(14)；
至少一个第二访问节点(12h)，与分布式数据库(14)分离地提供；以及
至少一个外部设备(50)，位于集群(10)外部，至少一个外部设备(50)能够通过至少一个第一访问节点(12a)或至少一个第二访问节点(12h)执行下述中的至少一个：(i)写入到分布式数据库(14)或(ii)从分布式数据库(14)读取。
12.根据权利要求11所述的医疗设备系统(110)，其中，至少一个第一访问节点(12a)和至少一个第二访问节点(12h)与医疗设备分离。
13.根据权利要求11所述的医疗设备系统(110)，其中，至少一个第一访问节点(12a)和至少一个第二访问节点(12h)设置有用户接口(18)或与用户接口(18)共同操作。
14.一种医疗设备系统(110)，包括：
集群(10)，包括多个节点(12)；
多个医疗设备，实施节点(12)中的至少一些；
至少一个节点(12)，其是包括外部部分(112a)和内部部分(112b)的访问节点(12a，12h)；
分布式数据库(14)，沿着集群(10)共享并由节点(12)中的至少一些托管，分布式数据库(14)，如果由至少一个访问节点(12a)存储，则与访问节点(12a)的内部部分(112b)相关联；以及
至少一个外部设备(50)，位于集群(10)外部，至少一个外部设备(50)能够通过访问节点(12a，12h)的外部部分(112a)执行下述中的至少一个：(i)写入到分布式数据库(14)中的至少一些或(ii)从分布式数据库(14)中的至少一些读取。
15.根据权利要求14所述的医疗设备系统(110)，其中，外部部分(112a)和内部部分(112b)由处理和存储器管理器(120)分离，所述处理和存储器管理器知道如何(i)将来自内部部分(112b)的数据放置到外部部分(112a)中和(ii)将来自外部部分(112a)放置到内部部分(112b)中。
16.一种医疗设备系统(110)，包括：
集群(10)，包括多个节点(12)；
多个医疗设备，实施节点(12)中的至少一些，每个医疗设备包括被配置为执行医疗程序(20)的处理和存储器；
分布式数据库(14)，通过节点(12)中的至少一些沿着集群(10)共享，分布式数据库(14)部署在多个医疗设备上，分布式数据库(14)由处理和存储器管理器(120)与被配置为执行医疗程序(20)的处理和存储器分离，所述处理和存储器管理器知道如何(i)将来自分布式数据库(14)的数据设置到被配置为执行医疗程序(20)的处理和存储器中和(ii)将来自被配置为执行医疗程序(20)的处理和存储器的数据设置到分布式数据库(14)中。
17.根据权利要求16所述的医疗设备系统(110)，其中，被配置为执行医疗程序(20)的处理和存储器被设置为通过处理和存储器管理器(120)发起与分布式数据库(14)的通信。
18.根据权利要求16所述的医疗设备系统(110)，其中，分布式数据库(14)位于医疗设备的集群控制部分(28b)中，所述集群控制部分与被配置为执行位于医疗设备的治疗控制部分(28a)中的医疗程序(20)的处理器和存储器分离，所述集群控制部分(28b)通过处理和存储器管理器(120)与治疗控制部分(28a)分离。
19.一种医疗设备系统(110)，包括：
集群(10)，包括多个节点(12)；
多个医疗设备，实施节点(12)中的至少一些；
分布式数据库(14)，沿着集群(10)共享并由多个医疗设备托管；
外部设备(50)，位于集群(10)外部；以及
集群(10)的虚拟访问节点(100)，与外部设备(50)和多个医疗设备之一共同形成，虚拟访问节点(100)提供安全的数据交换环境，以确保在外部设备(50)写入到医疗设备或(ii)从医疗设备读取时分布式数据库(14)的安全。
20.根据权利要求19所述的医疗设备系统(110)，其中，医疗设备包括第一虚拟访问节点接口(108a)，外部设备(50)包括第二虚拟访问节点接口(108b)，并且其中，安全的数据交换环境包括安全信道，诸如与虚拟访问节点接口(108a，108b)交互的虚拟专用网络(106)。
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CN110100283B (zh) 2023-07-04
AU2023248083A1 (en) 2023-11-02
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